OTC: RVRC

Our core business strategy combines disciplined
product candidate development with strategic deployment of internal expertise and effective use of external resources. We leverage our
experienced executive management team and our established networks throughout the biopharmaceutical industry to identify and develop product
candidates that we believe can provide superior clinical benefits to patients living with life-threatening conditions.

Nanoparticle-based therapies involve using
tiny particles (nanoparticles) to deliver drugs or other therapeutic agents to specific locations in the body, often with the goal of
enhancing treatment effectiveness and minimizing side effects. These nanoparticles, typically ranging from 1 to 1000 nanometers in
size, can be engineered to encapsulate various therapeutic agents, including proteins, nucleic acids, or small molecule drugs. Compared
to conventional drugs, nanoparticle-based drug delivery has specific advantages, such as improved stability and biocompatibility, enhanced
permeability and retention effect, and improved targeting to diseased tissues such as tumors or sites of infection.

While the abovementioned attributes have been
observed in preclinical models, there can be no assurance that they will be replicated in clinical studies or translate into meaningful
patient outcomes. Our product candidates are in early stages of development and have not yet been clinically tested in the United States
or elsewhere.

Corporate History and Recent Developments

Revium Rx was incorporated on January 24, 1997
as a Delaware corporation under the name “Fun Cosmetic, Inc.” On August 29, 2005, it changed its name to Grand Canal
Entertainment, Inc. On October 14, 2008, the Company merged with OC Beverage, Inc. a Nevada corporation, a manufacturer of beverages,
and on October 31, 2008 it subsequently changed its name to OC Beverages, Inc. It ceased operations as a manufacturer of beverages in
2010. On June 22, 2020, the Company formed a wholly owned Israeli subsidiary called Revium Recovery Ltd. On December 4, 2020, the Company
changed its name to Revium Recovery Inc.

On December 17, 2024, the Company completed the
redomicile from the State of Delaware to the State of Nevada by conversion (the “Reincorporation”), pursuant to the Plan of
Conversion dated December 16, 2024. As a result of the Reincorporation, the Company ceased its business existence as a Delaware corporation
and continued its business existence as a Nevada corporation under the name “Revium Rx” succeeding all our rights, assets,
liabilities and obligations, except that our affairs ceased to be governed by the Delaware General Corporation Law, the Certificate of
Incorporation, as amended, and became subject to the Nevada Revised Statutes, Articles of Incorporation and our new bylaws. The Reincorporation
did not change the number of the authorized shares of the Company, its par value, or its issued and outstanding shares.

1

Share Exchange Agreement

On July 23, 2024, we consummated the share exchange
transaction (the “Share Exchange”) contemplated by the Stock Exchange Agreement, dated November 14, 2023 (the “Share
Exchange Agreement”), by and among the Company, LipoVation Ltd., a company organized under the laws of the State of Israel (“LipoVation”),
and all shareholders of LipoVation (the “LipoVation Shareholders”). As a result of the consummation of the Share Exchange,
LipoVation became a wholly owned subsidiary of the Company. At such date, the shareholders of LipoVation contributed all of their shareholdings
in LipoVation in exchange for 23,171,642 shares of the Company’s Common Stock (the “Exchange Shares”) with each LipoVation
Shareholder receiving a pro rata portion of the Exchange Shares based on their ownership in LipoVation. The Exchange Shares represented
approximately 40% of the issued and outstanding shares of the Company’s Common Stock immediately upon the closing of the Share Exchange.

As a result of the Share Exchange, the Company
acquired the business of LipoVation, which became the primary business of the Company. Through LipoVation, the Company is dedicated to
developing novel nano-medicines to deliver advanced treatment solutions for diseases with limited or no effective medical options. Pursuant
to the license and research agreements with Yissum Research Development Company of the Hebrew University of Jerusalem, Ltd. (“Yissum”),
executed on November 24, 2022, as amended on October 25, 2023 (the “Yissum License Agreements”), LipoVation has exclusive
license rights to develop and market a novel technology related to Nano-Liposomal Particles (NLP)-based medicines including: (i) novel
formulation of a potent antibiotic which shows promise in combating several life-threatening antibiotic-resistant bacteria which currently
have no available treatment, (ii) potent adjunct to improve cancer treatment outcomes and (iii) novel immunization approach based on Liposomal
Protein-Loaded Technology (LPLT).

Prior to the closing of the Share Exchange, the
Company had been developing clinical decision-making support system (DMSS) in the field of mental health, including novel diagnostics
algorithm and treatment monitoring tools allowing for integrative care and evidence-based addiction treatment. After the closing
of the Share Exchange with LipoVation, the Company discontinued its prior activities and efforts with respect to the development and activation
of the DMSS and focused its business operations primarily on the acquired LipoVation’s business, specifically on developing and
marketing a range of novel NLP-based medicines to combat several life-threatening diseases which have no efficient treatment today.

Technology and Industry Overview

Market Opportunities

Nanoparticles-based therapies, also referred to
as nanomedicines or nano delivery systems, are employed to serve as means of diagnostic tools or to deliver therapeutic agents to specific
targeted sites in a controlled manner. Nanotechnology offers multiple benefits in treating chronic human diseases by site-specific, and
target-oriented delivery of precise medicines. These systems enable site-specific, controlled delivery of pharmaceutical agents, including
chemotherapeutic, biological, and immunotherapeutic compounds, with what we believe to be improved safety and efficacy profiles.

Liposomal and lipid-based nanoparticles are designed
to improve the therapeutic index of both novel and existing drugs by modifying pharmacokinetics, enhancing absorption, reducing metabolism,
extending biological half-life, and reducing toxicity [2]. These nanostructures circulate in the bloodstream for extended periods and
enable controlled drug release, thereby minimizing plasma fluctuations and associated adverse effects. Due to their nanoscale size and
their prolonged circulation in blood, they can potentially accumulate in tumors or inflamed tissues via the enhanced permeability and
retention (EPR) effect and improve cellular uptake. Studies have shown that nanoparticles (<200 nm) achieve greater cellular internalization
than microparticles (>1 µm), allowing for improved targeting while reducing off-target toxicity [2&3].

2

The advantages of liposomes as drug carriers are
well recognized. Over 20 liposomal and lipid-based formulations have received approval from the FDA and EMA, with many others in clinical
and preclinical development stages [4]. One of the earliest and most significant approvals in nanomedicine was Doxil™, a liposomal
formulation of doxorubicin co-invented by Prof. Barenholz and the first FDA-approved nanodrug.

More recently, lipid nanoparticles (LNPs) have
emerged as the leading non-viral delivery systems for nucleic acid-based therapeutics, including RNA interference (RNAi) and in vitro
transcribed (IVT) mRNA. Their role was central in the development and success of mRNA vaccines during the COVID-19 pandemic. These include:

●Pfizer-BioNTech
(Comirnaty): Used LNPs to encapsulate and deliver mRNA encoding the SARS-CoV-2 spike protein [5].

●Moderna
(Spikevax): Similarly relied on LNP technology for mRNA stabilization and delivery [6].

●Arcturus:
Developed an mRNA vaccine platform using LNPs, demonstrating the broader trend toward LNP adoption in mRNA vaccine development [7].

The demonstrated success of using LNPs as efficient
drug delivery means in COVID-19 vaccines has fueled expanded research into their application in gene therapy, oncology, and other infectious
diseases [8].

Our proprietary technology builds on the same
principles that made Doxil®, the first FDA-approved Nanomedicine using liposomal drug delivery, a success. We intend to
apply these principles to treat infectious diseases and cancer by encapsulating potent therapeutics in proven lipid-based particles, such
as those used in Doxil®. By encapsulating potent therapeutics, our approach is intended to enable controlled release, improve
biodistribution to the affected tissues, and extend systemic circulation time. These enhancements may collectively improve the therapeutic
index by increasing efficacy while potentially reducing systemic exposure and associated toxicities. However, there can be no assurance
that features will be replicated in clinical studies or translate into meaningful patient outcomes.

References

1.
De Villiers MM, Aramwit P, Kwon GS. Nanotechnology in Drug Delivery. Springer, 2008.

2.
Allen TM, Cullis PR. Liposomal drug delivery systems: From concept to clinical applications. Advanced Drug Delivery Revew. 2013;65(1):36–48.

3.
He Q, Zhang Z, Gao F, Li Y, Shi J. In vivo biodistribution and urinary excretion of mesoporous silica nanoparticles: Effects of particle size and PEGylation. Small. 2011;7(2):271–280.

4.
Sercombe L, Veerati T, Moheimani F, Wu SY, Sood AK, Hua S. Advances and challenges of liposome assisted drug delivery. Frontiers in Pharmacology. 2015;6:286.

5.
EMA Assessment Report – Comirnaty (BioNTech/Pfizer). EMA/707383/2020.

6.
Baden LR, El Sahly HM, Essink B, et al. Efficacy and safety of the mRNA-1273 SARS-CoV-2 vaccine. N The New England Journal of Medicine. 2021;384:403–416.

7.
Arcturus Therapeutics Press Releases, 2020–2021.

8.
Hou X, Zaks T, Langer R, Dong Y. Lipid nanoparticles for mRNA delivery. Nature Reviews Materials. 2021;6:1078–1094.

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Product Pipeline in
Development

Through LipoVation, our
operating subsidiary which we acquired in July 2024, we are developing programs in infectious diseases, oncology and vaccination.

We intend to use tiny, specially designed fat-based
particles called liposomes to carry powerful medicines directly to where they’re needed in the body. We believe that this method
is one of the more advanced ways to deliver medicine and allows the drugs to stay in the bloodstream longer, reach their target more precisely,
and release their effects in a controlled way. We believe that this approach is designed to improve drug delivery and treatment outcomes,
subject to validation in clinical studies. At Revium Rx, we’re leveraging these features to target diseased tissues, including tumors
and infected areas, thereby minimizing effects on healthy cells.

We are developing a portfolio of lipid based and
Nano-Liposomal Particle NLP-based pharmaceutical candidates and plan to complete the development and commercialization of a series of
medical technologies comprised of:

●A
nanoparticle-based formulation of mupirocin, a well-known and potent antibiotic which is currently limited to topical use due to its
instability in blood when administered systemically. Our novel Nano-Mupirocin formulation, supported by both in vitro and in vivo animal
studies, has demonstrated promising potential for the treatment of severe, life-threatening infections caused by antibiotic-resistant
bacteria, including Methicillin-Resistant Staphylococcus aureus (MRSA), Vancomycin-Resistant Enterococci (VRE), and resistant Neisseria
gonorrhoeae. If approved, the novel proprietary formulation of nano-mupirocin is intended to be administered systemically,
providing extended presence in the bloodstream and enhanced delivery of mupirocin to inflamed areas of the body.

●A
novel combination therapy designed to enhance the efficacy of existing cancer treatments: our novel nanoparticle-based formulation of
angiotensin receptor blockers (ARB), Nano-Candesartan, our second product candidate is being developed for intravenous administration,
and is intended to improve treatment outcomes when used in combination with established anticancer therapies, with an initial focus on
pancreatic cancer indication.

●
Liposomal Protein-Loaded Technology (LPLT), which is currently in early-stage development, represents a novel approach to immunization through innovative nanoparticle-based vaccines. We are currently awaiting the finalization of a SARS-CoV-2 challenge study involving 114 ACE2-transgenic mice by Prof. Barenholz and his team. It is expected to resume in Q4 2025 and conclude in the second quarter of 2026. We have an exclusive license to these liposomal based vaccines and know-how, including potential applications other than SARS-CoV-2. The results of the study are necessary to establish proof of concept (POC) as well as to inform the provisional patent application that we are currently working on. The results of this study are critical to determining the commercial viability of continued investment in this program.

These product candidates
are in early stages of development and have not yet been clinically tested in the United States or elsewhere. Even if preclinical studies
show promising results, there is no guarantee that such pharmaceutical candidate will demonstrate sufficient efficacy or safety in human
populations.

The diagram below illustrates our product pipeline
across the various stages of development.

*
Under Research and Option Agreement, subject to successful completion of large animal studies. For more details please see Our Second Product Candidate - Nano-Candesartan. If we are unable to reach an amicable resolution with Yissum that preserves our right to exercise the option, or if we ultimately elect not to exercise the option based on the results of the large animal study, our development pipeline would exclude the Nano-Candesartan product candidate. While the Company’s option to obtain an exclusive license for Nano-Candesartan is subject to uncertainty due to a disagreement with Yissum, this uncertainty does not affect the Company’s other development programs, including Nano-Mupirocin.

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Our leading Product Candidate --Nano-Mupirocin

Nano-Mupirocin is a novel NLP-based formulation
of a potent antibiotic mupirocin. Mupirocin is an antibiotic with a unique mode of action, not shared by any other therapeutically available
antibiotic. However, due to its rapid metabolic degradation following systemic administration and extensive plasma protein binding, the
therapeutic use of this well-established agent has been limited to topical application. The novel formulation of Nano-Mupirocin is specifically
designed to overcome the challenge of rapid metabolic degradation, enabling the development of a potent systemic therapy for life-threatening
antibiotic-resistant infections.

Antibiotic resistance occurs when bacteria change
in a way that makes antibiotics less effective or ineffective against them. This makes infections harder to treat and increases the risk
of disease spread, severe illness, disability, and death. Antibiotic resistance is driven by the misuse and overuse of antibiotics in
humans, animals, and plants, and is exacerbated by poverty and inequality.

Global Research on Antimicrobial Resistance (GRAM)
Project conducted and published by Cambridge University in 2024 demonstrated that globally antibiotic-resistant infections were directly
responsible for 1.45 million deaths and contributed to 5.35 million deaths in 2022. In the US alone, antimicrobial resistance was responsible
for 47,000 deaths and contributed to 180,000 deaths in 2022. [1]. These numbers are echoed by the 2022 report published by WHO. Health
management organizations and medical professionals around the world increasingly recognize antimicrobial resistance (AMR) as one of the
most urgent and escalating threats to global health and sustainable development.

We believe that our novel liposomal Nano-Mupirocin
product candidate may potentially present significant advancement in antibiotic therapy by enabling systemic use of mupirocin, a potent
topical antibiotic previously ineffective in systemic applications due to rapid degradation in blood. Through a PEGylated liposomal delivery
system, we believe that Nano-Mupirocin can be designed to achieve intracellular delivery, prolonged circulation time, and improve biodistribution
to the affected by the resistant bacterial tissue. This technology we are working to develop fills a critical therapeutic gap, particularly
for multidrug-resistant pathogens such as MRSA, VRE, rapidly emerging resistant pathogens of Gonorrhea, and others.

We believe that Nano-Mupirocin can address the
global Anti-Microbial Resistance (AMR) crisis by enabling highly potent systemic therapy for high-risk infections with limited existing
treatment options. The platform is being designed to offer improved affected tissue-selective delivery and intracellular access, unlike
current untargeted broad-spectrum antibiotics. We believe that our product candidate is being developed to establish a new therapeutic
standard and to potentially introduce a new class of liposomal anti-infective agents.

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Nano-Mupirocin technology overview

The nano-liposomal formulation
of Mupirocin is enhanced by adding hydroxypropyl-beta-cyclodextrin (HPCD) to the intraliposomal volume, allowing for Mupirocin controlled
release from the liposomes in blood. The novel Nano-Mupirocin’s efficacy has been demonstrated in various animal models, with two
of these studies sponsored by the National Institute of Health (US). Its pharmacokinetic profile in animal studies demonstrated increased
systemic exposure compared to the free drug, together with a substantially extended half-life. The in vitro spectrum of activity
for both Mupirocin and our liposomal Nano-Mupirocin was tested on many clinical isolates, showing no cross-resistance with other antibiotics.
Interestingly, similar Minimum Inhibitory Concentrations (MIC – the lowest concentration of the drug that inhibit visible growth
of a microorganism) were observed, indicating that Mupirocin remains active against bacteria while encapsulated in liposomes. However,
even if preclinical studies show promising results, there is no guarantee that such pharmaceutical candidate will demonstrate sufficient
efficacy or safety in human populations.

Additionally, Nano-Mupirocin was shown to penetrate
phagocytic cells and enhance the extermination of bacteria in vitro. Our internal data, which has not been independently verified, suggests
that our liposomal formulation has been well-tolerated in preclinical models.

The production process for Nano-Mupirocin is well-defined
and has been scaled up to approximately a 5-liter batch. There is expertise available to further scale up this process to 25 liters, based
on experience with other liposomal drug products. All excipients used in our novel formulation are pharmaceutical grade and approved for
human use.

Nano-Mupirocin: Preclinical Studies Proof on Concept in Vivo

To assess the systemic therapeutic potential of
Nano-Mupirocin, a PEGylated liposomal formulation of mupirocin, multiple preclinical studies were conducted using murine and rabbit models
of infection. These studies aimed to assess pharmacokinetics (PK), biodistribution, and efficacy against multidrug-resistant bacterial
infections, notably Staphylococcus aureus, including MRSA strains.

1.
Murine Model – Bloodstream Infection

A murine model of S. aureus bloodstream infection was used,
involving 9–10 week-old specific-pathogen-free C57BL/6 female mice (~20g, Envigo). Mice were intravenously inoculated with 10⁶
CFU of S. aureus strain 6850 via the tail vein. On day 3 post-infection, mice were randomized into three groups (Nano-Mupirocin,
free mupirocin, blank liposomes), each containing 10 animals. Treatments were administered IV (50 mg/kg) on day 3 and IP on days 4 through
7. Mice were sacrificed on day 8, and bacterial loads were quantified in the liver, kidneys, and tibia via serial dilution plating on
blood agar. Nano-Mupirocin significantly reduced bacterial loads in all organs tested compared to both control groups. Measurements also
included HPLC quantification of mupirocin in tissues and serum IL-6 levels, which were significantly lower in Nano-Mupirocin-treated animals,
indicating reduced systemic inflammation.

6

Representative figures from the animal model of bloodstream infection
are shown below:

Fig. 1. Superior therapeutic efficacy Nano-mupirocin
over the free drug after parenteral administration in a murine model of S. aureus bloodstream infection. (A) Schematic illustration of
therapeutic regimen. C57BL/6 mice were infected intravenously with 106 CFU of S. aureus strain 6850 and treated with either Nano-Mupirocin
(50 mg/kg), free mupirocin (50 mg/kg) or empty nanoliposomes (blank liposomes) intravenously at day 3 and intraperitoneally at day 4,
5, 6 and 7 of infection. Mice were sacrificed at day 8 of infection and mupirocin concentration and bacterial loads were determined in
kidneys and tibia. (B) Mupirocin concentration in kidneys and tibia of S. aureus-infected mice treated with Nano-mupirocin (white bars)
Nano-Mupirocin (white bars) or with free mupirocin (grey bars) at day 8 of infection. Each bar represents the mean ± SD of values
pooled from three independent experiments. Bacterial loads in kidneys (C) and tibia (D) of mice treated with either Nano-Mupirocin (triangles),
free mupirocin (squares) or blank liposomes (circles) at day 8 of infection. Each symbol represents the value for an individual animal
(n=10). Data were pooled from three experiments performed independently. Horizontal lines indicate the mean ± SD. (E) Changes in
body weight with the progression of infection in the different treatment groups. Each symbol represents the mean ± SD value of
n=5. One representative experiment out of three is shown. (F) Serum concentrations of IL-6 in uninfected or S. aureus-infected mice treated
with either Nano-Mupirocin, free mupirocin or blank liposomes at day 8 of infection. Each bar represents the mean ± SD of values
pooled from three independent experiments. **, p < .01; ***, p < .001.

Reference: Liposomal
mupirocin holds promise for systemic treatment of invasive Staphylococcus aureus infections; Oliver Goldmanna,, Ahuva Cern, Mathias Mueskenc,
Manfred Rohdec, William Weissd, Yechezkel Barenholzb, Eva Medinaa https://doi.org/10.1016/j.jconrel.2019.11.007

2.
Murine Model – Neutropenic Lung Infection

In a neutropenic lung infection model, female
CD-1 (ICR) mice (5–6 weeks old) were rendered neutropenic via cyclophosphamide (150 mg/kg and 100 mg/kg on days -4 and -1). Mice
were anesthetized and intranasally inoculated with ~5 × 10⁷ CFU of MRSA (UNT141-3). Treatment groups (n=5 per group) received
IV doses of Nano-Mupirocin (50 or 75 mg/kg), free mupirocin (same doses), or blank liposomes 2 hours post-inoculation. Additional control
groups were treated with vancomycin. Mice were euthanized at 24 hours, and lung bacterial loads were measured by plating organ homogenates
on selective agar. Nano-Mupirocin-treated groups showed up to 2.28 log₁₀ CFU reductions compared to free mupirocin at equivalent
doses.

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Representative results from the neutropenic lung infection animal model
are shown below:

Fig. 2. Therapeutic effect of parenterally
administered Nano-Mupirocin or free mupirocin against MRSA in a neutropenic murine model of lung infection. (A) Schematic illustration
of therapeutic regimen in neutropenic mice. CD1 mice were rendered neutropenic and infected intranasally with app. 5×107 CFU of
MRSA strain UNT141-3 and treated with the indicated dose of either Nano-Mupirocin, free mupirocin, Vancomycin or with blank nanoliposomes.
Mice were sacrificed at 24 h of infection and bacteria enumerated in the lungs. (B) Bacterial loads in the lungs of the different groups
of mice treated according to scheme depicted in (A) at 24 h of infection. Each symbol represents the value for an individual animal (n=5).
Horizontal lines indicate the mean ± SD.

Reference: Liposomal mupirocin holds promise
for systemic treatment of invasive Staphylococcus aureus infections; Oliver Goldmanna,, Ahuva Cern, Mathias Mueskenc, Manfred Rohdec,
William Weissd, Yechezkel Barenholzb,, Eva Medinaa https://doi.org/10.1016/j.jconrel.2019.11.007

3. Rabbit Model – Infective Endocarditis

A rabbit model of MRSA endocarditis was employed
using 2.2–2.5 kg New Zealand white rabbits. Animals were infected with ~10⁵ CFU MRSA (MW2 strain) and randomized (n=8 per
group) into three groups: Nano-Mupirocin (25 mg/kg IV BID), free mupirocin (same dose), or saline control. After 3 days of treatment,
animals were euthanized, and bacterial counts were determined in vegetations, kidneys, and spleen. Nano-Mupirocin-treated animals showed
statistically significant reductions in bacterial counts across all tissues compared to controls.

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Figure 3: Rabbit survival. Percent survival of rabbits in endocarditis study across the treatment groups.

Figure 4: Rabbit PK Profile. Mupirocin plasma concentrations after IV administration of 25 mg/kg Nano-mupirocin vs. free mupirocin.

Reference: Ahuva Cern, Ayelet Michael-Gayego,
Yaelle Bavli, Erez Koren, Amiram Goldblum, Allon E. Moses, Yan Q. Xiong and Yechezkel Barenholz* Nano-mupirocin: enabling the
parenteral activity of mupirocin DOI 10.1515/ejnm-2016-0006

4.
Murine Model – Necrotizing Fasciitis (Streptococcus pyogenes)

A dose–response study was conducted in a
mouse model of necrotizing fasciitis using group A Streptococcus (GAS). Mice (n=6 per group) received a single IV dose of Nano-Mupirocin
(1.1–57 mg/kg) one hour post-infection. Survival was monitored for 5 days. All untreated mice died within 48 hours. Complete survival
was observed at doses ≥11 mg/kg, with a clear dose-dependent protection from mortality and clinical symptoms.

Figure 5. Dose response to Nano-Mupirocin in a murine necrotizing fasciitis model.

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Figure 6: Mortality during the study and disease parameters (rough hair and wound development) 48 h after the bacterial challenge. (A) A study to compare one prophylactic dose of Nano-Mupirocin (50 mg/kg) vs. free mupirocin administered prophylactically and 3 and 24 h after the bacterial challenge. (B) A prophylactic dose response study. (C) Nano-Mupirocin administration after the bacterial challenge vs. free mupirocin administration. Survival of mice in response to increasing doses of Nano-Mupirocin.

Figure 7.  Appearance of a typical Nano-Mupirocin-treated
mouse (A) vs. an untreated one (B) 24 h after bacterial challenge.

Figure 8: Plasma profile of mupirocin after IV administration of
40 mg/kg free vs. Nano-Mupirocin.

Reference: Ahuva Cern, Ayelet Michael-Gayego, Yaelle Bavli, Erez
Korena, Amiram Goldblum, Allon E. Moses, Yan Q. Xiong and Yechezkel Barenholz* Nano-Mupirocin: enabling the parenteral activity
of mupirocin DOI 10.1515/ejnm-2016-0006/

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5.
Biodistribution and Pharmacokinetics

PK studies in mice (n=4 per time point) showed
that Nano-Mupirocin had a terminal half-life of 262 minutes vs. 5.3 minutes for free mupirocin. The area under the curve (AUC) was ~97-fold
higher for Nano-Mupirocin, confirming sustained systemic exposure. Biodistribution studies showed accumulation in infected organs and
in mucosal secretions (e.g., vaginal fluid), maintaining drug concentrations well above the MIC₉₀ for >24h

Figure 9: Vaginal Smear Fluorescence. Fluorescence
microscopy of vaginal smears. (A,B) are overlays of Differential interference contrast (DIC) and Fluorescent Light. (A), un-treated mice;
(B), mice treated with LRPE-Nano-mupirocin; (C,D), smears of LRPE-Nano-mupirocin observed under fluorescent light. Scale bar = 50 μm.

Figure 10: Mupirocin in Vaginal Secretions.
Mupirocin concentration (free (non-liposomal) plus liposomal) in vaginal secretions (ng/g) and plasma (ng/mL) following IP administration
of Nano-mupirocin 50 mg/kg (mean ± SE). (n = 5 for swab samples and n = 4 for plasma samples).

Substantial pre-clinical research of the novel
Nan-Mupirocin formulation has indicated that this novel approach may allow for a new potent therapy to combat bacteria listed as serious
and urgent threats by the Center for Disease Control (CDC), subject to clinical trials. Management believes that the novel formulation
of Nano-Mupirocin may hold the potential to serve as a highly potent systemic therapy for serious life-threatening infections, such as
resistant Gonorrhea, MRSA induced endocarditis, or sepsis.

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Key facts about mupirocin and findings from preclinical
research on Nano-Mupirocin:

-
Broad antibacterial activity. The antibacterial spectrum of mupirocin is well studied. Mupirocin is registered as a topical ointment (Bactroban™ by GlaxoSmithKlein). Mupirocin is known to be highly effective against staphylococci, streptococci, certain Gram-negative bacilli, including N. gonorrhoea and a broad range of Gram-positive bacteria. [1] Mupirocin’s activity is enhanced at acidic pH levels and is not significantly influenced by inoculum size, although its effectiveness decreases in serum due to high protein binding (95%). Its primary mechanism involves inhibiting RNA and protein synthesis by targeting the isoleucine-binding site on the isoleucyl-transfer-RNA synthetase enzyme in bacteria. This unique mode of action, different from other antibiotics, reduces the likelihood of cross-resistance.[2]

-
Spectrum and cellular uptake: Pre-clinical studies have indicated that Nano-Mupirocin has demonstrated a high level of tolerance, including activity against methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus faecium (VRE), and cephalosporin-resistant Neisseria gonorrhoeae [3]. This formulation indicated enhanced uptake by phagocytic cells such as macrophages and neutrophils, potentially improving intracellular antibiotic delivery and bactericidal activity [4].

-
No cross-resistance: Due to its unique mechanism, mupirocin does not display cross-resistance with β-lactams, glycopeptides, or other classes of antibiotics, making it valuable in treating resistant strains [2].

-
Preclinical profile: Nano-Mupirocin formulations appeared to be well tolerated in preclinical studies, with no significant adverse effects reported [3]. However, these are pre-clinical indications that need to confirmed in appropriate clinical studies.

-
WHO Priority Pathogens: The World Health Organization (WHO) lists MRSA, VRE, and Neisseria gonorrhoeae among its high-priority pathogens due to increasing antimicrobial resistance [5]. Nano-Mupirocin demonstrated activity against these bacteria which supports its potential relevance in global health initiatives.

A team of researchers from the National Institute
of Health in collaboration with Prof. Barenholtz’s team have demonstrated proof of concept in a number of preclinical studies performed
on resistant bacteria which causes severe life-threating infections including necrotizing fasciitis, endocarditis, and gonorrhea. A few
in vitro and in vivo studies testing novel LNP mupirocin were supported and conducted in collaboration with the National
Institute of Health/National Institute of Allergy and Infectious Diseases (NIH/NIAID). The results were published in the Antimicrobial
Agents and Chemotherapy journal [6] as well as in the Journal of Controlled Release [7].

While the abovementioned attributes have been observed in preclinical
models, there can be no assurance that they will be replicated in clinical studies or translate into meaningful patient outcomes.

References

1.
Williams JD. Antibacterial activity of mupirocin (pseudomonic acid), a new antibiotic for topical use. Antimicrobial Agents and Chemotherapy. 1985;27(4):495–498. DOI: 10.1128/aac.27.4.495

2.
DrugBank Online: Mupirocin (DB00410). DrugBank. https://go.drugbank.com/drugs/DB00410

3.
Kulkarni NS, et al. Therapeutic potential of injectable nano-mupirocin liposomes against MRSA and VRE infections. Pharmaceutics. 2021;13(11):1789. PMC8706398

4.
He W, et al. Enhanced uptake of antibiotic-loaded nanoparticles by macrophages improves intracellular killing of pathogens. Journal of Controlled Release. 2021;336:149–162.

5.
WHO. WHO Bacterial Priority Pathogens List, 2024. https://www.who.int/publications/i/item/9789240093461

12

6.
Cern A, Connolly KL, Jerse AE, Barenholz Y. In Vitro Susceptibility of Neisseria gonorrhoeae Strains to Mupirocin, an Antibiotic Reformulated for Parenteral Administration in Nanoliposomes. Antimicrob Agents Chemother. 2018 Mar 27;62(4):e02377-17. https://doi.org/10.1128/aac.02377-17

7.
O. Goldmann, A. Cern, M. Muesken, et al., Liposomal mupirocin holds promise for systemic treatment of invasive Staphylococcus aureus infections, Journal of Controlled Release (2019), https://doi.org/10.1016/j.jconrel.2019.11.007

Current Status

Our novel liposomal formulation of mupirocin remains in early-stage
development. The program is intended to follow, a 505(b)(2) pathway, leveraging a well-characterized antibiotic with established clinical
use. While we believe this approach may reduce certain aspects of development risk relative to a new molecular entity, there can be no
assurance that such pathway will result in reduced development timelines, lower costs, or diminished regulatory risk.

To date:

-We have completed scale-up of the manufacturing process to a 25-liter clinical batch, and final batch release is currently ongoing;

-GLP toxicology studies are ongoing and are currently expected to be completed by May 2026, subject to change;

-The program is supported by non-GLP toxicology data generated from preclinical studies; however, such data may not be predictive of
clinical outcomes;

-We have received approval from the Israeli Ministry of Health to initiate a Phase 1 clinical trial in Israel; however, the timing
and conduct of such trial remain subject to operational, regulatory, and financial considerations.

The Company is evaluating potential regulatory pathways that may include
eligibility for Qualified Infectious Disease Product (QIDP) designation and Fast Track designation. If granted, such designations may
provide certain regulatory benefits, including the potential for priority review and extended market exclusivity; however, there can be
no assurance that the Company will obtain any such designations.

The Company is also assessing potential indications that may qualify
for Orphan Drug Designation (ODD). Certain ODD-qualified indications, including rare paediatric diseases, may be eligible for a Priority
Review Voucher (PRV) upon regulatory approval. PRVs are transferable and have been monetized in prior market transactions; however, there
can be no assurance that the Company will obtain ODD status, qualify for a PRV, or realize any economic benefit from such voucher.

Further development, including clinical trials and regulatory approvals,
will require substantial additional funding. The Company intends to pursue strategic alternatives, including licensing, co-development,
or other partnering arrangements, to support further development and potential commercialization; however, there can be no assurance that
the Company will be able to enter into such arrangements on favourable terms, or at all.

IP protection

Several patents and licenses for Nano-Mupirocin
were already obtained in major countries and regions, including the U.S., Europe (in the table referred to as European Patent Office –
EP), Japan, India and China.

Pursuant to the Yissum License Agreements, we
have an exclusive, worldwide license for the development, use, manufacture and commercialization of products arising out of patents owned
by, and patent applications filed by, Yissum in connection with Liposomal formulation of Nano-Mupirocin. All of patents and patent applications
listed below were licensed to us by Yissum pursuant to the Yissum License Agreements.

13

All below patents are composition of matter patents.

Status

Country

Application

Date

Title (with

embodiment

where applicable)

Publication

Number

Patent Date

Patent Number

Expiry Date

Granted

US

Oct. 10, 2016

Liposomal Mupirocin

2017/0027869

June 26, 2018

10,004,688

April 8, 2035

Granted

EP

Oct. 11, 2016

Liposomal Mupirocin

3142642

August 29, 2018

3142642

April 8, 2035

Granted

EP-BE

Oct. 11, 2016

Liposomal Mupirocin

3142642

August 29, 2018

3142642

April 8, 2035

Granted

EP-DK

Oct. 11, 2016

Liposomal Mupirocin

3142642

August 29, 2018

3142642

April 8, 2035

Granted

EP-FR

Oct. 11, 2016

Liposomal Mupirocin

3142642

August 29, 2018

3142642

April 8, 2035

Granted

EP-DE

Oct. 11, 2016

Liposomal Mupirocin

3142642

August 29, 2018

6020150155610

(EP 3142642)

April 8, 2035

Granted

EP-IE

Oct. 11, 2016

Liposomal Mupirocin

3142642

August 29, 2018

3142642

April 8, 2035

Granted

EP-IT

Oct. 11, 2016

Liposomal Mupirocin

3142642

August 29, 2018

502018000035029

(EP 3142642)

April 8, 2035

Granted

EP-NL

Oct. 11, 2016

Liposomal Mupirocin

3142642

August 29, 2018

3142642

April 8, 2035

Granted

EP-CH

Oct. 11, 2016

Liposomal Mupirocin

3142642

August 29, 2018

3142642

April 8, 2035

Granted

EP-GB

Oct. 11, 2016

Liposomal Mupirocin

3142642

August 29, 2018

3142642

April 8, 2035

Granted

CN

Oct. 10, 2016

Liposomal Mupirocin

106659795

June 2, 2023

106659795

April 8, 2035

Granted

JP

Oct. 6, 2016

Liposomal Mupirocin

2017-513938

March 13, 2020

6676035

April 8, 2035

Granted

IN

Oct. 19, 2016

Liposomal Mupirocin

201627035738

November 23, 2020

351893

April 8, 2035

Market Opportunity and Estimated Commercial
Potential for Systemic Liposomal Nano-Mupirocin

First indication: Ceftriaxone-Resistant Gonorrhea
(CR-Gonorrhea)

Clinical Background and Unmet Need

Gonorrhea, caused by Neisseria gonorrhoeae, is
one of the most common sexually transmitted infections globally. The U.S. Center for Disease Control and Prevention (CDC) recommends Ceftriaxone
as the first-line treatment [2]. Resistance is a growing threat. However, strains resistant to Ceftriaxone are emerging, posing a serious
public health threat [3].

We are working to develop Liposomal Mupirocin
as a systemic treatment alternative for Ceftriaxone-resistant infections, with the potential to offer improved tissue penetration, higher
drug concentration at the site of the infection and sustained drug exposure.

Pricing Benchmark and Market Assumptions

Our pricing assumptions are based on comparison
between conventional small-molecule drugs and their nanoparticle/liposomal equivalents. For example, conventional Amphotericin B averages
approximately $51 per 50 mg dose (source: Drugs.com price guide), whereas liposomal Amphotericin B (AmBisome®) averages approximately
$341 per dose, reflecting a ~7x premium (Lee et al., Lancet Global Health, Sept 2024, “Paving the way for affordable and
equitable liposomal amphotericin B access worldwide”).

14

For Liposomal Nano-Mupirocin, we benchmarked against:

-
Ceftriaxone: the current recommended treatment for uncomplicated gonorrhea (including resistant strains) as recommended by CDC. Average price per treatment course is $538 [5]

-
Topical Mupirocin (~$45 per 50g). [6]

-
Based on these benchmarks and the ~7x premium commonly observed for liposomal formulations, we estimate a potential treatment course price of $315–$1,200, depending on market segment, with an illustrative base case of $600. The lower end of this range corresponds to assumptions of low-income or no-profit procurement pricing, while the upper end reflects premium pricing in private market segment.

These ranges are assumptions only. Nano-Mupirocin
is still in preclinical development and has not been approved by any regulatory authority. We do not yet know the final dosage, or number
of injections required per treatment course, and actual pricing will depend on multiple factors including clinical results, regulatory
approval, reimbursement, adoption, and competition.

Epidemiology and Estimated Market Opportunity for Resistant Gonorrhea
Indication

Gonorrhea is one of the most common
bacterial sexually transmitted infections (STIs) in the world with an estimated 82 million cases across the globe each year. In the United
States, the Centers for Disease Control and Prevention (CDC) reported approximately 710,000 cases in 2022, while estimating that the true
number of infections may exceed 1.5 million annually due to underreporting and asymptomatic cases. [7]

Gonorrhea has progressively developed resistance
to multiple classes of antibiotics historically used for treatment. According to the CDC, many infections demonstrate resistance to at
least one previously used antibiotic, and treatment options have become increasingly limited. Currently, cephalosporins, including ceftriaxone,
represent the primary recommended class of antibiotics for treatment in the United States.

Although resistance to ceftriaxone remains relatively
low, surveillance data from the WHO’s Gonococcal Antimicrobial Surveillance Program (GASP) and other sources indicate increasing
resistance trends to several antibiotics, including azithromycin and cefixime, in certain regions. These trends underscore the potential
for further erosion of treatment effectiveness over time [11]

As a result, the clinical and commercial opportunity
is driven not only by cases involving resistance to current first-line therapies, but also by the broader need for new treatment options
to address antimicrobial resistance and reduce reliance on a limited number of remaining effective antibiotics. However, the prevalence
and clinical impact of resistant infections may vary by geography and over time, and there can be no assurance regarding the size of the
what ? Total Addressable Market (TAM) for Ceftriaxone-Resistant Gonorrhea

The TAM represents the entire pool of patients who suffer from the
condition, have been diagnosed, and could theoretically benefit from our therapy.

U.S. Case

-
Assumed annual resistant gonorrhea cases: ~ 550,000

-
Ceftriaxone resistance prevalence: ~5%

-
Cefixime (another first-line cephalosporin) resistance - 11%

-
Azithromycin resistance prevalence - 4%

-
Assumed resistant infections of Nano-mupirocin target group: ~91,000 cases annually (16% of all resistant infection cases)

-

Estimated treatment cost per patient: $600

-

U.S. TAM = ~$55 million per year

15

Global Case

-
Resistance rates are higher in Asia and parts of Europe.

-
Conservative multiplier: 4× U.S. TAM

-
Global TAM ≈ $220 million per year

Thus, we estimate that $220 million represents
the maximum revenue ceiling assuming full penetration of all diagnosed resistant gonorrhea cases worldwide.

Serviceable Obtainable Market (SOM) –
Ceftriaxone-Resistant Gonorrhea

The Serviceable Obtainable Market (SOM) represents
the realistic portion of the global patient pool that can be accessed and captured by our therapy, accounting for geography, regulatory
pathways, healthcare access, and competitive penetration.

Launch strategies in infectious disease markets
typically achieve 20–40% penetration in high-need segments over five years. We conservatively assume 30% global market share capture.

Patient SOM

-
Global resistant infections: ~364,000 cases/year (based on 4× U.S. burden)

-
30% capture represents approximately 110,000 patients annually

-
U.S. contribution alone: ~27,000 patients (~$17M in revenue)

Revenue SOM

-
30% of $220M global market = ~$66–70M/year

SOM reflects a tangible, realistic revenue line,
not the theoretical ceiling (TAM).

Even at 30% penetration, the opportunity is substantial
and defensible due to:

-
Lack of effective alternative therapies for resistant gonorrhea

-
High clinical urgency and CDC/WHO surveillance prioritization

-
Concentrated patient pools in developed markets with strong reimbursement systems

Final SOM Opportunity

~110,000 patients/year treatable

~$70M/year realistic revenue potential at 30%
global penetration of the addressable market for Ceftriaxone-Resistant Gonorrhea

These estimates are illustrative only and based
on assumptions regarding TAM/SAM/SOM, pricing and epidemiology. Our product candidate is still in preclinical development and has
not been approved by any regulatory authority. We do not yet know the final dosage, or number of injections required per treatment course,
and actual pricing will depend on multiple factors including clinical results, regulatory approval, reimbursement, adoption, and competition.

16

Epidemiology and Estimated Market Opportunity
for Methicillin-Resistant Staphylococcus Aureus (MRSA), Including Vancomycin-Resistant (VRE) Cases

MRSA is a leading cause of hospital- and community-acquired
infections. The CDC estimates over 1.2 million MRSA infections annually in the U.S. with another 423,000 hospitalized patients colonized
with the bacteria [8]. While Vancomycin is standard therapy, resistance and treatment failures are increasing, prompting interest in second-line
options including liposomal Amphotericin B [9].

Our novel formulation of systemic Liposomal-Mupirocin
is positioned to target serious systemic MRSA infections, especially in Vancomycin-resistant or refractory cases.

Pricing Benchmark and Market Assumptions

-
Liposomal Amphotericin B (per dose): ~$120 (average worldwide without US)- ~$341 in the US [4], per course ~$1700-~4,700

-
Assumed Liposomal Mupirocin IV pricing: ~$220 per dose, with a total course cost ranging from ~$1,540 to $3,000 depending on the number of injections required. The exact dosage regimen and treatment duration remain to be determined during the planned clinical trials.

-
Assumed average pricing per course for illustration purposes: ~$2,200

U.S. incidence of MRSA:

-
Based on an estimated 32 invasive MRSA cases per 100,000 people [10], the U.S. (population ~330 million) has approximately 106,000 such cases annually

-
U.S. Total Addressable Market TAM for invasive infections:

-
106,000 × $2,200 = ~$230 million/year

-
Estimated annual revenue potential at 30% assumed realistic market penetration over 5 years (U.S. Serviceable Obtainable Market): ~$70 million

Global Total Addressable Market (TAM) assumptions rationale:

-
We estimate the global market at roughly 3 times the size of the U.S. market at around $690 million.

-
Estimated global annual realistic revenue potential at 20% market penetration, which represents serviceable obtainable market (SOM): ~$130+ million

Based on the epidemiological data and pricing
assumptions outlined above, the following table summarizes our estimates for the total addressable market (TAM) and serviceable obtainable
market (SOM) for liposomal mupirocin.

17

Prospective Market Opportunity Summary with Detailed Assumptions
and Limitations

Parameter

Resistant Gonorrhea

Invasive MRSA

U.S. Annual Cases

~91,000 ceftriaxone-resistant infections 5% of 710,000 total U.S. Gonorrhea cases

~106,000 invasive MRSA infections 32/100,000 × 330M population

Estimated Cost per Treatment

~$600

~$2,200

U.S. TAM

~$55M 91,000 cases × $600 per treatment cost

~$230M ~106,000 cases × $2,200 per course of treatment

Global Multiplier

4×* higher prevalence in Asia/Europe, robust disease surveillance, outpatient uptake

3×* hospital-based, formulary controls, stronger generic competition, ex-U.S. price compression

Global TAM

~$220M

~$690M

Assumed Market Penetration

30% U.S. faster uptake due to limited alternatives, outpatient setting

20% globally slower adoption, higher generic competition, hospital stewardship

U.S. SOM

~$17M 30% of $55M TAM

~$70M 30% of $230M TAM

Global SOM

~$70M (30% of $220M)

~$130M (20% of $690M)

Key Limitations Assumptions

Product candidates are not yet approved; treatment regimens remain to be defined. It is assumed that Gonorrhea requires a shorter treatment course than MRSA, resulting in a lower cost per patient, whereas MRSA incurs significantly higher per-course costs. Market penetration percentages are illustrative, epidemiology varies by region, and treatment policies differ substantially across geographies

Explanatory note: For invasive MRSA we apply
a conservative 3× U.S. for global multiplier, versus 4× for ceftriaxone-resistant gonorrhea, due to the following:

●
Care setting: MRSA treatment is hospital-based and tightly controlled by stewardship/formulary policies, slowing adoption abroad. Gonorrhea is outpatient, single-dose, and rapidly updated in global protocols.

●
Competition & use patterns: MRSA faces entrenched, low-cost generics (vancomycin, linezolid, daptomycin), with new drugs often reserved for salvage cases. Gonorrhea has few alternatives, so resistance drives faster substitution and greater demand not just in the U.S., but globally.

●
Pricing & procurement: anti-MRSA agents face steep ex-U.S. discounts, limiting revenue scaling. Gonorrhea pricing is lower but scales more directly with higher patient volumes.

To conclude:

●
MRSA (3×): reflects slower uptake, stronger generic competition, and price compression.

●
Gonorrhea (4×): reflects higher ex-U.S. burden, faster uptake, fewer alternatives, and more direct revenue translation.

The assumed pricing profile is based on benchmarks
from systemic antibiotics used for resistant infections. While the potential application of Nano-Mupirocin in high-mortality, high-cost
indications such as invasive MRSA supports commercial attractiveness and meaningful global revenue potential, these estimates are our
assumptions that are illustrative only. Actual outcomes will depend on future clinical trial results, regulatory approvals, regional treatment
guidelines, reimbursement decisions, and market adoption.

Our product candidate is still in preclinical
development and has not been approved by any regulatory authority. We do not yet know the final dosage, or number of injections required
per treatment course, and actual pricing will depend on multiple factors including clinical results, regulatory approval, reimbursement,
adoption, and competition.

18

References

1.
https://www.tropicalmedicine.ox.ac.uk/gram/news/drug-resistant-enteric-fever-has-risen-53-percent-since-1990-gram-study-estimates

2.
CDC (2022). Gonorrhea Treatment Guidelines. https://www.cdc.gov/std/treatment-guidelines/gonorrhea.htm

3.
WHO (2021). Antimicrobial Resistance in Gonorrhea. https://www.who.int/news-room/fact-sheets/detail/antimicrobial-resistance

4.
Red Book Online (2024). Amphotericin B and AmBisome Pricing Data.

5.
GoodRx (2024). Ceftriaxone Average Cost. https://www.goodrx.com/ceftriaxone

6.
Drugs.com (2024). Mupirocin Ointment Pricing. https://www.drugs.com/price-guide/mupirocin

7.
CDC (2022). STD Surveillance Report – Gonorrhea. https://www.cdc.gov/std/statistics/2022/default.htm

8.
CDC (2020). Healthcare-Associated Infections (HAI) Reports – MRSA.

9.
NIH/NIAID. Treatment Failures and Resistance Trends in MRSA

10.
Incidence, prevalence, and management of MRSA bacteremia across patient populations—a review
of recent developments in MRSA management and treatment, Critical Care. Hassoun et al, Aug 2017

11.
https://www.ashasexualhealth.org/antibiotic-resistant-gonorrhea-is-on-the-rise-globally.

Our Second Product Candidate - Nano-Candesartan

The Company’s next drug candidate is another
novel nanoparticles-based formulation of angiotensin receptor blockers (ARBs), also known as AT1 receptor blockers (AT1) for intravenous
(IV) administration – Nano-Candesartan.

Nano-Candesartan, our nanoparticles-based formulation of an angiotensin
receptor blocker (ARB), is being evaluated as a potential combination therapy candidate, with an initial focus on pancreatic ductal adenocarcinoma
(PDAC), an indication with a significant unmet medical need.

ARBs is a class of drugs that block the
Angiotensin II Type 1 receptor (AT1), which is involved in the regulation of blood pressure, fluid balance, and inflammation. ARBs have
been widely used for the treatment of hypertension, heart failure, and diabetic nephropathy. Several recent studies have shown that ARBs
may have certain anti-cancer enhancement features. Among other, ARBs can inhibit proliferation, migration, invasion, and angiogenesis
of tumor cells, as well as induce apoptosis and autophagy. ARBs may also modulate the immune response by affecting the polarization and
activation of macrophages, T cells, and natural killer cells.

By “combination therapy” we refer
to the administration of nano-candesartan with other oncology agents, such as approved chemotherapy drugs and/or immune checkpoint inhibitors
(immunotherapy agents such as Keytruda).

Novel formulation of Nanoparticles-based ARB (nano-ARB)
was designed to improve the therapeutic outcome of chemotherapy and biological treatments, such as antibodies and immune checkpoint inhibitors
for solid cancers. Solid cancers, such as breast, lung, colon, pancreas and prostate cancers, present a formidable challenge to oncologists,
as they are often resistant to existing treatments and have poor prognosis. One major obstacle lies in the complex tumor microenvironment
(TME), which consists of various cellular and non-cellular components that interact with each other and with the tumor cells. The TME
creates a physical and immunological barrier that impairs the delivery and effectiveness of anti-cancer drugs. For example, the tumor
blood vessels are leaky and irregular, resulting in poor perfusion and hypoxia. The extracellular matrix (ECM) within the TME is dense
and fibrotic, making it difficult for drugs to penetrate and reach their intended targets. The TME also contains various immune cells,
such as macrophages, T cells, and natural killer cells, that can either suppress or enhance the anti-tumor immune response, depending
on their polarization and activation state.

19

To overcome the challenges posed by the TME, nano-ARB
is targeting one of the key cellular structures in the TME: cancer-associated fibroblasts (CAFs). CAFs are fibroblasts that are recruited
or transformed by tumor cells. CAFs have a multifaceted role in cancer progression, influencing everything from tumor mechanics to the
immune system. CAFs secrete various growth factors, cytokines, chemokines, and ECM components that can promote tumor growth, angiogenesis,
invasion, metastasis, and drug resistance. CAFs can also modulate the immune response by attracting or repelling immune cells, or by inducing
immunosuppression or immune activation.

As illustrated in the diagram below, the tumor
microenvironment (TME) hinders drug delivery and diminishes the treatment outcomes of existing therapies. Incorporating the nano-ARB component
is intended to assist in overcoming this barrier by normalizing the TME through decompression of tumor blood vessels and reprogramming
of fibroblasts. As a result, therapeutic penetration is expected to be significantly enhanced.

The diagram is hypothetical and conceptual in
nature. It is based on published scientific literature third party studies describing the role of ARBs in tumor stroma normalization and
on exploratory preclinical studies conducted in animal models, and is not derived from clinical data with our Nano-ARB (Nano-Candesartan)
product. As such, the diagram reflects management’s current development hypothesis as to treatment outcomes.

Previous clinical evidence from retrospective
analyses and early human trials conducted by third parties suggested that cancer patients receiving candesartan or other AT1 receptor
antagonists showed improved responses to treatments such as gemcitabine and other chemotherapies (1,2). The blood pressure–lowering
effect of ARBs is well documented and generally well tolerated in patients already using them as antihypertensives; however, it may raise
concerns in individuals not accustomed to anti-hypertensive (HT) medication. However, there can be no assurance that these results will
be replicated in large scale human clinical studies or future clinical trials will demonstrate an acceptable safety profile, or that the
product will be tolerated in patients, or that it will show clinically significant results.

With respect to combination therapy, findings
from a large population-based clinical study (1) demonstrated that ARB exposure after a pancreatic cancer diagnosis was significantly
associated with improved survival. These results suggest that ARBs may represent an important therapeutic consideration for pancreatic
cancer patients, particularly those with the poorest prognosis and limited treatment options. The results of the study are presented below.

20

Figure 11: Kaplan– Meier curves
for overall survival by treatment groups. The median overall survival was 15.1 months in the ACEI/ARB group, 8.9 months in the non-ACEI/ARB
with hypertension group, and 9.5 months in the non- hypertension group (1)

In another clinical study evaluating the combination
of gemcitabine and candesartan (2), the investigators recommended a candesartan dose of 16 mg alongside gemcitabine for the treatment
of advanced pancreatic cancer. The study concluded that this regimen is both feasible and safe in normotensive patients, with encouraging
efficacy reflected in a high disease control rate and prolonged progression-free survival. The authors further recommended continued investigation
of this approach in larger trials.

Additionally, a retrospective study by Wilop
et al. (3) examined the impact of ARBs and other agents on survival in patients with advanced non-small-cell lung cancer undergoing
first-line platinum-based chemotherapy. The researchers found that the addition of an ARB to platinum-based therapy was associated with
prolonged survival. This clinical observation aligns with previous experimental findings suggesting that ARBs may exert direct antiproliferative
effects on tumor cells and/or their microenvironment.

Fig. 12. Estimated survival from 1st cycle
of chemotherapy in the entire patient group according to long-term medication with (n = 52) or without (n =235) ACEI (Angiotensin converting
enzyme inhibitor) or ARB (P =0.03, log rank test) (3)

Described above clinical and preclinical findings
suggest that blockade of the angiotensin receptor may favorably modulate the tumor microenvironment, reduce immunosuppressive signaling,
and enhance responsiveness to anticancer agents. Based on this, we believe that administration of our novel formulation of Nano-Candesartan
could provide dual benefits: maintaining stable blood pressure profiles in patients while offering a clinically significant and tolerable
therapeutic effect in oncology settings.

21

Pre-clinical Studies on Nano-Candesartan

Preclinical exploratory studies performed in Prof.
Barenholz’s laboratory evaluated liposomal formulations of angiotensin receptor blockers (ARBs), including Candesartan, in animal
models of several solid tumors. These studies investigated tolerability and biological activity of liposomal ARBs in combination with
standard anticancer agents. While exploratory in nature and not designed to demonstrate definitive clinical efficacy, the results lend
scientific rationale for further investigation of Nano-Candesartan as a combination therapy candidate. No preclinical results were obtained
from third-party studies; all studies were conducted exclusively by Prof. Barenholz’s team.

Key findings of pre-clinical results obtained
by Prof. Chezy Barenholz and his team at the Hebrew University of Jerusalem:

-
Passive targeting. PEGylated nano-liposomes can exploit the enhanced permeability and retention (EPR) effect allowing for passive targeting of tumors, without the need for specific ligands or receptors.

-
Selective release. Specially engineered liposomes can release ARBs selectively within tumors, minimizing systemic effects on blood pressure while achieving TME normalization. The nano-ARB liposomal specific characteristics might trigger the release of ARBs in response to the acidic or proteolytic environment of the TME.

-
Proof-of-concept blood pressure effect studies Non-GLP exploratory studies performed by Prof. Barenholz’s team evaluated whether nano-encapsulated ARBs produced systemic blood-pressure effects after IV administration. Four groups of five mice each received single doses of PEGylated liposomal candesartan or valsartan (1–3 mg/kg). Mean arterial pressure was measured over 24–48 hours using a CODA® noninvasive tail-cuff system. Free valsartan reduced mean blood pressure within two hours, whereas nano-encapsulated ARBs produced no measurable decrease in blood pressure at comparable doses. This study assessed only relative BP effects and was not designed to evaluate safety. (Figure 13 provides a conceptual illustration.).

●
In vitro assay for drug release in tumors was developed and was found to correlate the release in the presence of tumors.

●
Lead formulations of valsartan and candesartan liposomes were selected based on having high loading efficiency (low % of free drug), in vitro slow release in serum and more rapid release in medium relevant to tumors.

●
The effect of valsartan liposomes in vivo on mice Blood Pressure (BP) was tested and compared to similar dose of free valsartan. The study showed that indeed the free drug lowered mice but the liposomal drug did not affect it. Fig 13

●
Initial studies with candesartan liposomes (25% HPCD formulation) showed no reduction in MBP, similar to the results obtained for valsartan formulations. Fig.13

22

FIG.13 Mouse blood pressure (mmHg) after free
valsartan or liposomal valsartan (25 mg/kg) administration as determined using blood pressure monitor device.

However, the safety of Nano-Candesartan has not
yet been evaluated in any clinical studies, and there can be no assurance that future clinical trials will demonstrate an acceptable safety
profile, that the product will be tolerated in patients, or that it will show clinically significant results.

To strengthen translational relevance, we plan
to conduct a dose-dependent study to evaluate the effect of the lead formulation on blood pressure in large animals. This program will
include detailed evaluation of multiple safety and pharmacological parameters relevant to intravenous administration, thereby informing
the clinical development pathway.

Following the large animal studies, we plan to
undertake a series of IND-enabling preclinical studies. These include therapeutic efficacy testing of the lead formulation in chosen cancer
models to assess its anti-cancer activity. Preliminary pharmacokinetics and tumor biodistribution studies in mice will be performed to
understand the absorption, distribution, metabolism, and excretion of the drug, as well as its accumulation in tumors. Concurrently, bioanalytical
methods will be developed and validated to quantify the drug and its metabolites in biological samples.

The Company also intends to scale up the manufacturing
process from lab scale to pilot scale, ensuring consistency in the formulation. Stability studies will follow, involving the development
of analytical methods to monitor stability and the performance of long-term and accelerated stability tests to define the shelf life and
storage conditions of the lead formulation.

In this way, management expects that the Company
will be able to proceed with submission of an IND application with the FDA and preparedness for clinical trials, subject to raising additional
capital. In the event that results from large-animal studies are supportive, we anticipate initiating clinical trials in the second half
of 2027.

We believe that combination therapy may offer
potential advantages beyond clinical performance. Because Nano-Candesartan may be paired with more than one class of established therapies,
the platform has the potential to enable collaborations with multiple pharmaceutical companies. This flexibility may create opportunities
for strategic partnerships and broaden the commercial applicability of the program.

However, developing a drug as part of a combination
regimen introduces unique complexities compared to monotherapy. In clinical development, combinations must demonstrate not only the safety
and efficacy of the investigational product itself, but also its added value beyond existing standards of care. This requires larger and
more complex trial designs, often involving multiple treatment arms to isolate the contribution of each agent. Regulatory agencies may
request mechanistic justification and additional data to ensure that the benefit is not solely attributable to the approved partner drug.

23

From a marketing perspective, positioning a combination
therapy is also more challenging. Uptake depends on alignment with established treatment paradigms, pricing relative to existing regimens,
and reimbursement policies. Physicians may hesitate to adopt combinations unless clear superiority in outcomes is demonstrated.

IP Protection.

The ATI Receptor Blockers technology is covered
by patent applications listed below, which, subject to our exercising our option to obtain the license, will be the subject of an exclusive
to us by Yissum.

Title: Liposomal Formulations Comprising
AT1 Receptor Blockers (ARB) and Uses Thereof (Composition matter and use claimed)

Status

Country

Application Date

Application

Number

Publication Date

Publication

Number

Expiry Date

Pending

US

July 15, 2022

17/793,254

April 27, 2023

2023/0129331

March 25, 2041

Pending

EU

October 25, 2022

21718237.7

February 8, 2023

4125809

March 25, 2041

Pending

CN

August 26, 2022

202180017153.5

October 11, 2022

115175664

March 25, 2041**

**Note: this application was abandoned and divisional application
in CN was filed. The divisional has not been published yet (as of January 22, 2026)

Current Status

In 2023, we entered into an option agreement with
Yissum, the technology transfer company of the Hebrew University of Jerusalem, relating to a preclinical liposomal angiotensin receptor
blocker (Nano-Candesartan, or ARB) program. Under the terms of the agreement, following completion of four designated preclinical studies,
Yissum is required to deliver a final scientific report summarizing the results of those studies. Delivery of this final scientific report
is a condition precedent to the commencement of a 90-day option exercise period, plus an additional 120-day negotiation period, during
which we may negotiate an exclusive license to the ARB program.

As of the date of this report, we do not believe
that Yissum has delivered a final scientific report that meets the definition set forth in the ARB option agreement. Certain data, analyses,
and supporting materials that we understood would form part of the final scientific report remain outstanding. In addition, research activities
continued throughout 2024 and 2025 under the approved research plan, with the knowledge and involvement of Yissum and University personnel,
further supporting our understanding that the option period had not yet commenced.

In November 2025, Yissum informed us that, in
its view, the ARB final scientific report had been delivered in September 2024 and that the option exercise period had therefore expired.
We dispute this position and have communicated to Yissum that the September 2024 report did not include the components specified under
the agreement and therefore does not constitute a final scientific report. We and Yissum are currently engaged in discussions to resolve
this matter, and there can be no assurance as to the timing, outcome, or potential impact of these discussions on our rights under the
option agreement.

Subject to the outcomes of our discussions with
Yissum, we intend to proceed with an evaluation of the proposed collaboration opportunities and assess their feasibility, alignment, and
potential impact. originally expected in the and now anticipated in the second half of 2026, before determining whether to exercise the
exclusive license option. Initiation of this study has been delayed pending receipt of what we consider to be the contractually required
final scientific report. If we are unable to obtain the exclusive license to the ARB program or determine not to pursue it, the Nano-Candesartan
program would no longer be part of our development pipeline. Given the uncertainty of our rights to the option, we have determined to impair the recorded value of intangible asset associated with
this program. Notwithstanding the need for further agreement on these matters, we present below
our current understanding of the development efforts, pre-clinical studies and potential market opportunities relating to the Nano-Candesartan
product candidate.

24

References:

1.
Keith SW, Gerber DE, Raghavan D, Galsky MD, Lin J, Wang L, et al. Angiotensin blockade therapy and survival in pancreatic cancer. BMC Cancer. 2022;22(1):920. doi:10.1186/s12885-022-09200-4

2.
Nakai Y, Isayama H, Ijichi H, Sasaki T, Kogure H, Yagioka H, Yamamoto K, Arizumi T, Hamada S, Miyabayashi K, Mizuno S, Kawakubo K, Yamamoto N, Hirano K, Sasahira N, Tateishi K, Tada M, Koike K. Phase I trial of gemcitabine and candesartan combination therapy in normotensive patients with advanced pancreatic cancer: GECA1. Cancer Science. 2012;103(8):1489-92. doi:10.1111/j.1349-7006.2012.02311.x

3.
Wilop S, von Hobe S, Crysandt M, Esser A, Osieka R, Jost E. Impact of angiotensin I converting enzyme inhibitors and angiotensin II type 1 receptor blockers on survival in patients with advanced non-small-cell lung cancer undergoing first-line platinum-based chemotherapy. Journal of Cancer Research and Clinical Oncology. 2009;135(10):1429–1435. doi:10.1007/s00432-009-0589-1

Clinical Background and Unmet Need

The global anticancer therapeutics market is undergoing
rapid growth, driven by the rising incidence of cancer and advancements in treatment technologies. According to The Brainy Insights, the
market was valued at approximately $222.71 billion in 2023 and is projected to reach around $885.44 billion by 2033, reflecting a compound
annual growth rate (CAGR) of 14.80% from 2024 to 2033.

The Nano-Candesartan platform has broad potential
applicability across multiple cancer indications. Although preclinical studies have demonstrated activity in various tumor models, our
initial clinical development will focus on Pancreatic Ductal Adenocarcinoma (PDAC) as the first indication in which efficacy will be evaluated
in humans.

PDAC is a highly aggressive malignancy with extremely
limited treatment options and a very poor prognosis. Current standard therapies offer only modest survival benefits, and there remains
a significant unmet need for more effective and better-tolerated treatments. PDAC remains one of the deadliest malignancies with a 5-year
survival rate under 11% [1]. The current standard of care for advanced PDAC includes combination chemotherapy with Gemcitabine (Gemzar®)
and Nab-Paclitaxel (Abraxane®), and provides only a limited survival benefit. Angiotensin receptor blockers (ARBs), including generic
candesartan, have shown preliminary promise as modulators of the tumor microenvironment. Based on these findings, it is hypothesized that
ARBs may have the potential to enhance the clinical outcomes of anti-cancer therapies, especially such deadly cancer as pancreatic.

Our novel formulation of liposomal ARB, Nano-Candesartan,
is being developed as a potential combination therapy with standard-of-care agents such as Gemcitabine (Gemzar®) and Nab-Paclitaxel
(Abraxane®). The objective of this approach is to explore whether modulation of the tumor microenvironment could improve tumor penetration
and potentially reduce systemic risks such as blood pressure lowering. Preclinical data suggest Nano-ARB may also influence cancer-associated
fibroblasts (CAFs) and vascular permeability, which could support enhanced delivery and retention of therapeutic agents within the tumor
(EPR effect). However, these observations are based solely on preclinical findings. There can be no assurance that such effects will be
observed in human studies, that they will translate into clinically meaningful outcomes, or that regulators will view these results as
sufficient for approval.

Epidemiology and Market Size Estimates for Nano-Candesartan (Liposomal
ARB) in Pancreatic Cancer

Global Revenue Potential for Nano-Candesartan in Pancreatic Cancer

U.S. incidence of Pancreatic Cancer is estimated
at ~61,000 new cases per year. [4] Global incidence is estimated at ~495,000 cases annually. [5]

25

Revenue assumptions (U.S. Market Only):

-
Per Patient Per Month (PPPM) cost of treatment: estimated at $3,700–$7,400

-
Assumed average duration of treatment course (based on 3–4 months of use): 3.5 months

-
Per-patient course cost: $12,950 downside case scenario – $25,900 upside case scenario. Downside case scenario here reflects pricing at the lower end of the estimated range, driven by reimbursement pressure, competition, or a shorter treatment course. Upside case scenario reflects pricing at the upper end of the estimated range, aligned with premium pricing observed for other liposomal oncology agents demonstrating significant clinical benefit, or a longer treatment course. Final treatment duration will depend on outcomes from future clinical trials.

U.S. TAM based on the estimated 61,000 patients/year may then translate
to:

~$790 million to $1.58 billion/year downside and upside case scenario
respectively.

Global Revenue Potential for Nano-Candesartan in Pancreatic Cancer

Global TAM assumed at roughly 4 times the size of the U.S. market at
around $690 million:

-
~$3.2 billion in downside case scenario

-
~$6.3 billion in upside case scenario

Serviceable Obtainable Market (SOM) for
Nano-Candesartan in Pancreatic Cancer

At an assumed ~50% market penetration, projected
U.S. revenue could reach approximately $390–790 million annually under the downside and upside case scenarios. This reflects the
premium pricing typical of targeted liposomal oncology therapeutics, the severity of pancreatic cancer, U.S. payer willingness to reimburse
high-cost treatments, and the lack of effective alternatives.

At assumed ~20% market penetration, projected
global revenue could reach $632 million to 1.26 billion annually. This reflects the premium pricing typical of targeted liposomal oncology
therapeutics, but also accounts for lower payer ability to reimburse outside the U.S. and greater variability in adoption and uptake across
geographies.

Estimated Market Opportunity Summary for Nano-Candesartan (Liposomal
ARB) in Pancreatic Cancer

Geography

Estimated

Annual Cases

Assumed Pricing (per patient)

TAM (100%

Coverage)

SOM (Realistic

Penetration)

U.S.

~61,000 new PDAC cases

~$12,950–$25,900 (3.5 months PPPM: $3,700–$7,400)

~$0.8B–$1.6B

~$390M–$790M

at ~50% penetration

Global

~495,000 new PDAC cases

~$12,950–$25,900 (same per-patient assumption)

~$3.2B–$6.3B

~$0.6B–$1.3B

at ~20% penetration

The assumed pricing profile is based on benchmarks
from other liposomal oncology drugs. While its potential use in a high-mortality, high-cost indication supports commercial attractiveness
and significant global revenue potential, these estimates reflect our assumptions that are illustrative only. Actual outcomes will depend
on future clinical trial results, regulatory approvals, regimen.

This product candidate is still in preclinical
development and has not been approved by any regulatory authority. We do not yet know the final dosage, or number of injections required
per treatment course, and actual pricing will depend on multiple factors including clinical results, regulatory approval, reimbursement,
adoption, and competition.

26

References

1.
American Cancer Society. Pancreatic Cancer Survival Rates. https://www.cancer.org

2.
GoodRx (2024). Gemzar and Abraxane Pricing Estimates. https://www.goodrx.com

3.
Drugs.com (2024). Candesartan Cost Data. https://www.drugs.com

4.
SEER Cancer Statistics (2023). Pancreatic Cancer Incidence – United States. https://seer.cancer.gov

5.
GLOBOCAN 2022. Global Pancreatic Cancer Incidence and Mortality. https://gco.iarc.fr

6.
Solid Tumor Therapeutics Market Size by Cancer Type, by Drug Type, Regions, Global Industry Analysis, Share, Growth, Trends, and Forecast 2024 to 2033”. The Brainy Insights, January 2024

Liposomal Protein-Loaded Technology: Scientific
Background Overview

Under the agreements with Yissum, we have a broad exclusive license
for all human application utilizing liposomal based vaccines. The initial indications that we are pursuing in this regard relate to COVID
19 and West Nile virus.

Currently, there are four (4) different platforms that are used to
develop viral vaccines:

●
Whole virus

●
Protein-based

●
Viral vector

●
Nucleic acid

Virus based vaccines can be live attenuated and
inactivated.

The live attenuated vaccine (LAV) requires genetic
manipulation to develop low-replication variants of the virus that cannot cause disease but can elicit a similar immune response to that
seen in natural infections. It has been linked to genetic instability and the presence of residual virulence.

Inactivated vaccines are part of the standard
viral vaccination technique. Because these vaccines contain many antigenic components, they have the ability to elicit a wide range of
immune responses. Compared to live-attenuated vaccines, they are generally associated with lower reactogenicity but may also elicit weaker
immune responses.. For inactivated vaccines to be effective, multiple inoculations and powerful combination therapies may be required.

Protein-based vaccines

Subunit vaccines implement purified immunogenic
proteins or peptides. For example, the majority of Coronavirus (CoV) subunit vaccines target the Spike protein, particularly its receptor
binding domain (RBD) which is highly immunogenic. Vaccination targets include viral structural proteins such as small envelope protein
E, envelope spike protein S, nucleocapsid protein N, and matrix protein M. Sever Acute Respiratory Syndrome SARS-CoV RBD antibodies cross-react
with the respective protein, and the resultant antisera neutralises the virus, shows that a vaccination targeting the S protein domain
could be successful in preventing Coronavirus. The S protein of full-length i.e., S1, S2 subunit and RBD, proteins were identified as
critical epitopes for generating neutralising antibodies as per computational analyses and studies on the viruses, SARS-CoV and MERS-CoV
(Middle East Respiratory Syndrome-CoV). Antibodies against the RBD domain have early been shown protection against SARS and MERS-CoV infections,
and the S1 epitope, containing both the RBD as well as N-terminal binding domain, NTD, has also been used to develop vaccines. A cluster
of T cell epitope was discovered in the transmembrane part of the M protein, allowing the development of a significant cellular type of
immune response against the SARS-CoV. For instance, Novavax Inc. (Gaithersburg, Maryland) used Matrix-M combination therapy recombinant
protein nanoparticle technology and the Sf9 system to develop the subunit vaccine candidate for SARS-CoV-2. The antigen in Clover Biopharmaceuticals
Inc.’s (Shanghai, CN) S-Trimer vaccine is a recombinantly generated homotrimer of the full-length S-protein.

27

A protein subunit vaccine, also known as a combination
therapy recombinant vaccine, is assembled of virus components that enhance the human immune system without incorporating virus particles
into the body. In 2020, Russian Federation established recombinant adenovirus vectors of type 26 (rAd26) and type 5 (rAd5), both of which
carry the SARS-CoV-2 Spike protein gene. This vaccine was also shown to induce a strong cellular and humoral immune response.

Other protein-based vaccines consist of virus-like
particles (VLPs), the recombinant proteins or supramolecular structures which may contain one or more copies of 10–200 nm nanoparticles
assembling viral proteins. Virus-like particles are created using structural proteins that have been recombinantly generated (VLPs). VLPs,
the S protein of SARS-CoV-2, facilitate host cell fusion via ACE2 receptor binding and priming via TMPRSS2, unlike in subunit vaccines
where VLPs seem to be unable to directly attach to B cell receptors to form the antibodies. The VLPs of SARS-CoV-2, which are derived
from genetically modified plants, have been shown to be effective in the production of neutralizing antibodies. Gene-based vaccines (GBVs)
GBV encloses RNA, DNA, and the viral vector platforms and also each of them contributes peculiar advantages and disadvantages.

DNA vaccines, which are generally made up of a
plasmid vector that encodes a target vaccine molecule and can elicit longer period of cellular and humoral immunity, can be mass-produced
in large quantities. This type of vaccine does not require the use of live viruses and may be freeze-dried and stored for a long time
even though in underdeveloped countries, a major issue like power outages can be faced where some vaccine batches become inoperable. Through
DNA vaccines, immune responses are prompted against recombinant antigens encoded by genetically engineered DNA plasmids.

The immune system is able to recognize these foreign
antigens generated by the host, resulting in a complete and adequate immunization. RNA-based vaccines invigorates the immunogen production
via induction of both cellular and humoral immune responses. These vaccines also act on DNA based vaccine’s principle with an exception
that there is no need of translocation to the nucleus for RNA transcription.

The display of viral proteins, such as the SARS-CoV-2
coat Spike protein, triggers humoral (neutralizing antibodies) and cellular responses that protect the recipient from the viral infection
as well as from future infections. Thus, this approach requires both efficient mRNA delivery into target cells and the identification
of suitable nucleic acid molecules that would trigger effective anti-viral immune response. BNT162b1, a lipid-soluble nanoparticles-based
formulation containing mRNA encoding the S protein RBD trimer, was produced by Pfizer and BioNTech.

Viral vector vaccines often consist of attenuated
recombinant virus, designed to encode sequence of an antigen for host cell delivery for high level endogenous production of that antigen
and thus induces elevated levels of cellular and humoral immune responses. These vaccines grant increased capabilities of gene transduction
because of the natural host cell infection ability of the viruses and these are of replicating or non-replicating. They are constructed
to transmit one or many antigens, as well as the capacity to load a big genome suggest that a wider range of vaccines might be developed.

Whole virus and protein vaccines are well-established
platforms. Examples of whole virus, live attenuated vaccines are measles-mumps-rubella vaccine and rotavirus vaccine; inactivated vaccines:
hepatitis A and rabies; and protein vaccines: hepatitis B and acellular pertussis. Viral vector and nucleic acid (mRNA and DNA) vaccines
are more novel platforms. The only viral vector vaccine licensed for human use is the Ebola vaccine by Merck.

The success of the vaccines from Pfizer-BioNTech
(BNT162b2, also known as Comirnaty®) and Moderna (mRNA-1273, also known as Spikevax®) in combatting Coronavirus has demonstrated
the value and rapid translational potential of lipid nanoparticles.

28

The Coronavirus pandemic introduced many millions
of people to mRNA vaccines, saving many lives. These vaccines consist of two main components:

-
An mRNA molecule, a fragile single strand polymer of nucleic acid that instructs the host cells to produce predetermined protein(s)

-
A lipid nanoparticles (LNPs) coating that enables an efficient delivery of nucleic acids into living cells.

Upon injection these vaccines into the muscle,
the mRNA in the vaccine is taken up by muscle cells and muscle immune cells that start producing the desired protein and displaying it
to specialized immune cells. Despite of wide vaccination with the newly introduced mRNA vaccines, since 2020, the rapid evolution and
spread of new Covid variants have caused severe illnesses and national lockdowns, proving to the world how critical it is to prepare for
future potential pandemics.

Mutations of other dangerous viruses that are
easily transferred from animals to humans, such as bird flu, can erupt at any moment, bringing the global healthcare system to the brink
of collapse, as well as triggering a social and economic crisis similar to what occurred during Covid. New mutations of known deadly viral
diseases, such as Ebola, can pose a rapid and aggressive threat to the entire world.

Novel Approach: LPLT by LipoVation

Our team has been focusing on the development
of Liposomal Protein-Loaded Technology (LPLT), a novel immunization platform that we are evaluating for potential use in developing vaccines
against a variety of viral diseases, including Coronavirus, West Nile Virus, Zika, HIV and others. The platform incorporates a proprietary
lipid and a CCS-based delivery system designed to protect virus-specific antigens and support their delivery. This approach may enable
coverage of a broader range of antigens, beyond the spike protein, which could potentially improve the breadth of immune responses. However,
this program remains at a preclinical stage, and there can be no assurance that these features will translate into safety or efficacy
in humans or that regulatory authorities will view them as sufficient for approval.

We are currently awaiting the completion of a
SARS-CoV-2 challenge study involving 114 ACE2-transgenic mice, conducted by Prof. Barenholz. It is expected to conclude in the first quarter
of 2026. The study is designed to evaluate the short- and long-term outcomes of the LPLT approach-based vaccination. The results of the
study are also intended to inform us of the provisional patent application that we are currently working on. The results of this study
are critical to determining the commercial viability of continued investment in this program. Prof. Barenholtz’s study was scheduled
to be completed in the third quarter of 2025 but has been delayed due to contamination of the specialized BSL-3 unit designed for research
of dangerous infectious agents that can be transmitted through the air and cause serious, potentially lethal disease.

The LPLT-based immunization platform is being
designed to:

-
Significantly improve vaccines’ efficiency and be more durable than mRNA vaccines and, potentially, provide longer-lasting protection;

-
Provide broader cross-immunity to protect against new virus variants;

-
Expected to boost the immune system of people vaccinated with other vaccines as well as to effectively stop the spread of the pandemic;

Recent animal studies conducted by Prof. Barenholz
suggest that the new LPLT technology may have the potential to induce immune responses and generate antibody levels in preclinical models.
This novel immunization approach is being evaluated for its ability to broaden immune protection, including potential effects on mucosal
immunity. Such effects, if confirmed, could be relevant in addressing viral mutations. However, these observations are limited to preclinical
models, and there can be no assurance that they will be replicated in clinical studies, result in meaningful patient outcomes, or be considered
sufficient by regulatory authorities for approval.

LPLT technology may potentially have several advantages
over the current methods of protein delivery. Firstly, this unique CCS drug-delivery technology is designed to protect the proteins from
degradation and clearance by the immune system or the liver, thus increasing their half-life and reducing the frequency and dose of administration.
Secondly, it can improve the biodistribution and accumulation of the proteins at the desired sites of action, such as inflamed tissues,
or infected cells, thus increasing their efficacy and reducing their side effects.

29

LPLT protein delivery technology is patent
protected.

Title: Vaccines: Sphingolipids Polyalkylamines
Conjugates for Vaccination

All composition of matter patents

Pursuant to the Yissum License Agreements, we
have an exclusive, worldwide license for the development, use, manufacture and commercialization of products arising out of patents owned
by, and patent applications filed by, Yissum in connection with LPLT vaccination approach.

The patent listed below was licensed to us on
an exclusive basis by Yissum pursuant to the Yissum License Agreements.

Status

Country

Application Date

Publication Number

Patent Date

Patent Number

Expiry Date

Granted

US

May 5, 2006

2006/0252717

March 18, 2014

8,673,285

February 18, 2027

The U.S. patent referenced above relate to the
proprietary lipid-based delivery system developed in Prof. Barenholz’s laboratory at the Hebrew University of Jerusalem. This patent,
protects the composition and method of use of a liposomal nanoparticle platform incorporating ceramide carbamoyl spermine (CCS) for the
delivery of recombinant protein antigens in vaccine formulations. They include composition of matter claims and methods of use for prophylactic
and therapeutic immunization.

Planned Patent Applications and Timeline

Our liposomal vaccine platform is designed to
co-encapsulate multiple recombinant protein antigens within a proprietary lipid nanoparticle system incorporating ceramide carbamoyl spermine
(CCS), a synthetic lipid developed to enhance immunogenicity, antigen stability, and mucosal delivery. As mentioned previously, this platform
has been initially evaluated in preclinical models for two viral targets: SARS-CoV-2 and West Nile Virus (WNV). The dual-antigen design
includes the receptor binding domain (RBD) and nucleocapsid (N) proteins for SARS-CoV-2, and the EDIII and NS1 proteins for WNV, offering
both neutralizing antibody and T-cell mediated immune responses.

Assuming the acceptable outcome of the ongoing
long-term challenge animal study and our positive determination as o the commercial viability of the protein-based vaccine, we plan to
submit a new provisional patent application we are covering the co-encapsulation of specific protein combinations targeting additional
viruses, beyond SARS-CoV-2 and WNV. The new patent applications will focus on the antigen-specific compositions designed for each selected
virus. These applications are expected to be submitted following completion and internal review of the final reports from both the West
Nile Virus (WNV) and SARS-CoV-2 preclinical proof-of-concept and challenge studies. The key remaining milestones include: (i) completion
and analysis of both short and long-term SARS-CoV-2 challenge study dataset, and (ii) drafting of patent claims specific to each antigen
formulation.

There can be no assurance that these applications
will result in issued patents, that any patents granted will provide meaningful protection, or that they will not be challenged by third
parties.

Current Stage of Development

The vaccine candidates have completed initial
preclinical proof-of-concept studies in rodent models. A short-term challenge study in BALB/c mice, conducted by Prof. Barenholz’s
team at specialized BSL-3 unit, assessed immunogenicity, mucosal and systemic antibody titers, T-cell responses, viral clearance, and
histopathology following intranasal administration. Preliminary results suggested a favorable immunogenicity profile, including mucosal
IgA and T-cell responses, as well as potential reductions in viral load and lung injury in the treated groups. Of course, there can be
no assurance that these features will be demonstrated in clinical studies or translate into meaningful treatment outcomes.

A long-term proof-of-concept (POC) challenge study
using the SARS-CoV-2 virus is planned to be completed Q1 2026. In addition, a similar formulation targeting WNV using the same lipid-based
delivery system is being evaluated in rodents. These data sets are critical for assessing the platform’s modularity and will help
guide further development decisions, inform potential intellectual property filings, and support the design of our regulatory strategy.

30

24 Months Development Plan

Upon receipt and internal review of the final
challenge study reports, the Company plans to:

1.
Evaluate go/no-go decision for advancement of either the SARS-CoV-2 or WNV vaccine candidate based on immunological outcomes and strategic alignment.

2.
In the event a decision is made to advance development, we intend to initiate IND-enabling studies for the selected candidate, including GLP toxicology and safety pharmacology studies in accordance with FDA guidelines.

3.
Develop clinical study protocol and prepare a standard IND submission for the chosen indication, with the goal of initiating a Phase 1 clinical trial focused on safety and immunogenicity in healthy volunteers.

Contingent R&D Milestones (12–24
months):

Milestone

Target Timeline

Final report of challenge/POC studies (SARS-CoV-2 and WNV)

Q1 2026

Internal review and candidate prioritization

Q2 2026

IND-enabling GLP studies initiation

Q3 2026-Q3 2027

GMP manufacturing + Pre-IND submission (standard pathway)

Q3-Q4 2027

Phase 1 trial initiation (pending IND clearance)

Q2 2028

Yissum Research and License Agreements

Our rights to the foregoing are based on research
and license agreement with Yissum, the tech transfer company of the Hebrew University in Jerusalem. Below is a summary of the principal
terms of these agreements.

On November 24,
2022, LipoVation entered into the Yissum Agreements, which were subsequently amended. Pursuant to the Yissum License Agreements, Yissum
granted LipoVation an exclusive, worldwide, sublicensable license to develop, have developed, manufacture, have manufactured, use, market,
distribute, export, import and/or sell products and/or processes that comprise, contain or incorporate certain technology relating to
the Nanoparticles-based liposomal therapeutics, including the above noted patents (the “Licensed Patents”). Under the terms
of the Yissum Agreements, Yissum retains the ownership of the Licensed Technology (as such term is defined therein). All rights in the
results of the activities carried out by LipoVation or third parties in the development of these products shall be solely owned by LipoVation
(unless an employee of the Hebrew University of Jerusalem or each of its branches is an inventor of any of the patents claiming such results,
in which case they shall be owned jointly by Yissum and LipoVation). LipoVation m has the right to grant sub-licenses to third parties
in accordance with the terms set forth in the Yissum Agreements.

Notwithstanding granting LipoVation the exclusive
license, Yissum and the Hebrew University of Jerusalem retained the right to make non-commercial, academic use of the technology at the
Hebrew University, including academic research sponsored by third parties that does not conflict or interfere with the license. In addition,
Yissum may grant licenses to third party academic or research institutions for non-commercial, academic research and teaching purposes
provided that any results from such efforts shall be the sole property of Yissum and shall be exclusively licensed to LipoVation under
the agreement. If Yissum desires to license or divest any of the intellectual property rights, the Company has the right of first negotiation
with respect to such rights. Under the license agreement, we are responsible for, and are required to exert, reasonable commercial efforts
to carry out the development, regulatory, manufacturing and marketing work necessary to develop and commercialize products under the agreement
in accordance with a specified development plan.

31

We paid Yissum a $35,000 license fee, and on each
anniversary date of the agreement we owe pay Yissum an annual license maintenance fee of $35,000. The license fee is credited against
royalties due to Yissum, and if we paid Yissum $100,000 during the previous year for research activities the license fee for said year
is not due. Pursuant to the terms of the license agreement, we owe Yissum $150,000 upon the first patient being enrolled in a Phase I
clinical trial; $300,000 upon the first patient in a Phase II clinical trial; $450,000 upon the first patient being enrolled in a Phase
III clinical trial; and $600,000 upon the earlier of the first commercial sale in either Europe or the U.S.

Royalties will be payable to Yissum at the rate
of 3% of sales of any products which use, exploit or incorporate technology covered by the Licensed Patents (“Net Sales”).

We also have to pay Yissum 13% of any proceeds
we receive from sublicensees other than royalties from a sublicensee.

The exclusive license agreements are in effect,
if not earlier terminated pursuant to the provisions of the Yissum Agreement, on a country-by-country, product-by-product basis, upon
the later of: (i) the date of expiration in such country of the last to expire Licensed Patent included in the Licensed Technology; (ii)
the date of expiration of any exclusivity on the product granted by a regulatory or government body in such country; or (iii) the end
of a period of twenty (20) years from the date of the first commercial sale in such country. Should the periods referred to in items (i)
or (ii) above expire in a particular country prior to the period referred to in item (iii), above, the license in that country or those
countries shall be deemed a license to the Know-How during such post-expiration period.

Either LipoVation or Yissum may terminate the
agreement immediately upon written notice to the other relating to bankruptcy and insolvency matters, upon 90 days’ written notice
of a material breach if such breach is not cured, and upon 90 days with notice of a non-material breach, is such breach is not cured.
Notwithstanding the foregoing, a party is entitled to an extra 45 days to cure a breach if the breach is not capable of cure during the
stated period if the breaching party uses diligent good faith efforts to cure the breach. In addition, Yissum may terminate the agreement
(a) immediately if an attachment is made over our assets and/or execution proceedings are taken against us and are not set aside within
60 days of the date of attachment or proceedings, as applicable and (b) if we fail to pay, in full, the research fee under a related sponsored
research agreement upon 45 days’ notice, subject to certain exceptions. We may terminate the license agreement for any reason on
30 days’ prior written notice to Yissum.

Termination of the agreement will result in the
termination of the license and, accordingly, the Licensed Technology and all rights included therein will revert to Yissum. All sublicenses
under the agreement are required to provide that, upon termination of the license, in whole or in part, that is, with respect to any country,
the sublicense shall terminate; provided that as long as the sublicensee is not in breach of the sublicense agreement at such time to
the extent that we would have the right to terminate the sublicense, Yissum will be required to act in one of the two following ways:
either (a) enter into a new agreement with the sublicensee upon substantially the same terms as the sublicense as long as the terms are
amended such that Yissum is not subject to any obligation or liability which are not included in, or in greater scope than, Yissum’s
obligations or liabilities under the license agreement; or (b) require the sublicensee to enter into a new license agreement on substantially
the same terms and conditions as those contained in the license agreement.

We have the first right to prepare, file, prosecute and maintain
any patent applications and patents in respect of the licensed technology and any part thereof, at our expense, subject to certain conditions.
We are required to file each licensed patent application at least in the United States, Europe and Japan. We are also required to take
action, in reasonable commercial circumstances and after consultation with patent counsel, in the prosecution, prevention or termination
of any infringement of patents licensed under the agreement. We are responsible for the expenses of any patent infringement suit that
we bring, including the expenses incurred by Yissum in connection with such suits. We are entitled to reimbursement from any awards or
settlements recovered in such suit or in the settlement thereof for all costs and expenses involved in the prosecution of any such suit.
If we elect not to pursue any action in connection with infringement and Yissum in good faith disagrees with us that it is in the mutual
best interest of both parties not to pursue any such action, then, at our election, we may either allow Yissum to pursue such actions,
at Yissum’s expense, or pay Yissum the royalties that Yissum would otherwise receive from us attributable to lost sales resulting
from such alleged infringement

32

Research and Option Agreement with Yissum for
the ARB Blockers

On October 25, 2023, we entered into Research
and Option Agreement with Yissum with respect to the nanoparticles-based formulation of angiotensin receptor blockers (ARB) for intravenous
administration. Under the agreement, we shall provide funding for research and development studies to be performed by researchers at Hebrew
University related to the formulation, preparation and characterization of nanoparticles-based formulation of angiotensin receptor blockers
(ARB) for intravenous administration. In consideration for the research services, we agreed to pay research service fees of $150,000,
in periodic payments subject to completing specified milestones. All data generated from the provision of the services, including any
reports, which are specifically required and contemplated under such agreement, shall be owned by us upon full payment of the research
services fees. If a patentable invention arises from the research, we shall be responsible for funding the costs of the patent application.
Each party will be entitled to terminate the agreement in the event of a breach by the other party of its obligations under the agreement,
including, but not limited to, any payment failure, which is not remedied by the breaching party within 30 days of receipt of written
notice from the non-breaching party.

The Company has the exclusive right within 90
days from receipt of the final scientific report to exercise the option to obtain an exclusive worldwide license for the production and
commercialization of products with the underlying solution, and then the parties have up to 120 days to negotiate the specific terms of
the license. If the parties fail to negotiate a license within said time period, Yissum shall have no further obligations to the Company.

As of September 30, 2025, we have paid Yissum
a total of $226 ,000 pursuant to the Research and Option Agreement, as amended.

Subject to receiving a final report as to the
results of the research, we have the exclusive right to enter into a license agreement substantially on the same terms as our current
license agreement with Yissum. The research is continuing.

However, as discussed above under the caption
“Our Second Lead Candidate, Nano-Candesartan (nanoparticles-based ARB), is being targeted for combination therapy with an initial
indication in pancreatic ductal adenocarcinoma (PDAC), if we are unable to reach an amicable resolution with Yissum that preserves
our right to exercise the option, or if we ultimately elect not to exercise the option based on the results of the large animal study,
our development pipeline would exclude the Nano-Candesartan product candidate.

The disagreement with Yissum relates solely to
the Nano-Candesartan program and does not affect the Company’s other development programs, including Nano-Mupirocin.

Our Growth Strategy

The Company plans to recruit an in-house development
team, with members working on several projects simultaneously to save costs and maximize knowledge and expertise. Where relevant stages
of the process will be subcontracted, with members of our team supervising their work.

We aim to progress with the continuous research
and developments activities, to develop additional applications using its technologies and to develop
future product candidates and the necessary clinical trials until such time as they can be commercialized through licensing to
larger pharmaceutical companies which will take responsibility for completing advanced stages CTs trials, like Phase III and obtaining
regulatory approvals and marketing the products.

In connection with our Development of Nano Mupirocin, we are planning
to:

●
Seek funding through a potential clinical collaboration agreement through partnerships with U.S. government entities and non-profit organizations, such as BARDA and CARB-X in the United States and Israeli Innovation authority (IIA) for conducting Phase I Clinical Trials.

●
Implement strategy to minimize time to realization of the Nano Mupirocin, including:

-
forging strategic alliances with established pharmaceutical companies and pursuing non-dilutive funding through governmental and non-governmental grant programs, early in the development process, especially Phase 1-2 clinical trials. These partnerships could range from non-profit organizations like Carb-X for advancing novel treatment development to co-development with larger Pharma companies. However, there can be no assurance that such funding will be awarded or sufficient to support our development plan;

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-
Concentrating on indications where antibiotic resistance poses a significant and immediate clinical challenge, and where Nano-Mupirocin can offer a distinct advantage;

-
Accelerating regulatory approvals through pathways
like Breakthrough Therapy Designation or Priority Review;

-
Utilizing adaptive regulatory pathways and engaging
in early dialogue with regulatory agencies to expedite the development timeline in order to achieve early regulatory milestones;

-
To further develop and strengthen its IP strategy and submit more patent applications for methods of production and methods of use, including Orphan Drug Designation protection for chosen disease.

●
To generate high-impact publications in reputable scientific and medical journals in collaboration with KOLs and leading researchers.

●
If we successfully conduct clinical trials, we plan to publish pivotal trials data and to present at major pharmaceutical and medical industry conferences. Positive data can significantly increase valuation and attract acquisition interest.

Our strategy for maximizing long-term value includes:

●
Expanding the development program to include a wider range of indications, demonstrating the versatility and broad applicability of Nano-Mupirocin across various infectious diseases. This can significantly enhance the long-term market potential.

●
Developing a comprehensive target market strategy that includes key regions affected by antibiotic resistance. Tailoring market approaches to fit regional healthcare landscapes is expected to maximize adoption and revenue generation.

●
Cultivating long-term relationships and collaborations with key institutions, health organizations, such as Israel Innovation Authority WHO and NIH, NGOs, and governments, especially in regions with high burdens of antibiotic-resistant infections. These partnerships can facilitate market access, drive adoption, and support public health initiatives.

With respect to Development of ARB combination therapy, our strategy
includes:

●
Early Collaborative Ventures: Initiate strategic collaborations with leading oncology-focused pharmaceutical companies early in the development cycle, particularly following promising preclinical results or early-phase clinical trial success. These collaborations could encompass licensing deals, co-development agreements, or joint ventures, aimed at leveraging external expertise and resources to accelerate ARB’s progression through clinical development and regulatory pathways.

●
Target High-Impact Indications: Prioritize cancer indications where the tumor microenvironment (TME) significantly impacts treatment outcomes and where current therapeutic options are limited. Focusing on these indications can potentially facilitate expedited regulatory approvals, such as orphan drug status or breakthrough therapy designation, enhancing ARB’s attractiveness to potential partners and acquirers.

●
Strategic Regulatory Engagement: Pursue early and continuous engagement with regulatory bodies to navigate the development process efficiently, utilizing programs like the FDA’s Fast Track and Priority Review to shorten the timeline to market authorization.

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●
Robust IP Portfolio Development: Expand and protect the intellectual property landscape around main ARB patent, including its unique liposomal formulation manufacturing methods and potential use cases across various solid tumors.

●
Data Publication and Presentation: Strategically release clinical trial results and other key data milestones at major oncology conferences and in high-impact journals to maximize visibility and interest from the oncology community, investors, and potential acquirers.

●
Timely Exit Considerations: Evaluate exit opportunities following pivotal Phase 2 data, which often serves as an inflection point in valuation for emerging oncology therapies, balancing the potential for further value appreciation against the risks and costs of later-stage development.

●
Expanding Therapeutic Range: Broaden the scope of ARB’s development program to explore its potential across a diverse array of solid tumors, capitalizing on the versatility of the liposomal formulation to address multiple facets of the TME. This expansion can significantly enhance ARB’s market potential and long-term value.

●
Enduring Partnerships and Collaborations: Forge and maintain strategic partnerships with academic institutions, research organizations, and cancer advocacy groups to advance ARB’s development and adoption. Engaging with the broader oncology community can foster support for ARB’s innovative approach to cancer treatment. We also plan to engage with major pharmaceutical companies regarding existing cancer therapy products in the market, aiming to collaborate and integrate our combination therapy nano-ARB with approved treatments. This collaboration aims to facilitate lower doses, improve toxicity profiles, enhance treatment efficacy, and reduce resistance to current therapies.

By adhering to this multi-path strategy,
we are planning to ensure that the ARB project is optimally positioned to navigate the complexities of the oncology field, from developmental
hurdles to regulatory approvals and market entry, aligning our efforts with the ultimate goal of transforming cancer treatment paradigms.

In this regard, we note that there can be no assurance
that we will be able to secure above referenced development partnerships or collaborations. However, we do not rely on public funding
and continue to pursue multiple funding strategies to support our development programs. If we are unable to successfully contract with
third parties for development support, we may need to target less indications and/or raise additional funds to continue advancing our
product candidates.

Manufacturing

Development plan and Chemistry, Manufacturing,
and Controls (CMC)

CMC activities are centered on the development
of manufacturing methods, scaling up processes, and preparing Nano-Mupirocin for clinical trials. We do not own or operate, and currently
have no plans to establish, any manufacturing facilities.

We have engaged, and currently rely on, a single
third-party CMO, STA Pharmaceutical Hong Kong Limited, a Hong Kong corporation and an affiliated company of WuXi AppTec a global pharmaceutical
CDMO providing integrated drug discovery, development & manufacturing services across Asia, Europe & North America for the supply
of our product candidates for use in our preclinical studies and future clinical trials. Should our CMO become unavailable to us for any
reason, we believe that there are a number of potential replacements, although we would incur delay and cost in identifying and qualifying
such replacements. We maintain a master services agreement with STA Pharmaceuticals pursuant to which it has agreed to provide substance
development and manufacturing services on a per-project basis. The agreement includes confidentiality and intellectual property provisions
to protect our proprietary rights related to our product candidates. While any reduction or halt in supply from the CDMO could limit our
ability to develop our product candidates until a replacement CDMO is found and qualified, we believe that we have sufficient supply to
support our current clinical trial programs. See “Risk Factors” for additional information. As of today, the 25L clinical
batch manufacturing has been completed and its final release is underway.

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WUXI STA has developed the production process,
ensuring compliance with regulatory standards while effectively scaling up to produce clinical trial batches. The analytical methods necessary
for product characterization are developed by our R&D team in close collaboration with WUXI STA. These methods are intended to assess
critical attributes of the drug product, including potency, impurity levels, particle size distribution, and stability. They form the
foundation of quality control and regulatory compliance efforts. Simultaneously, we have initiated the bioanalytical methods development.
These bioanalytical methods are intended to support the validated quantification of Nano-Mupirocin and its metabolites in relevant biological
matrices and will be used to generate pharmacokinetic and metabolism data in preclinical studies and subsequent clinical trials. Metabolite
analysis, performed in collaboration with STA Pharmaceutical, aim to provide deeper insights into the drug’s pharmacokinetics and
metabolism. This dual approach ensures a thorough characterization of Nano-Mupirocin, laying the groundwork for successful clinical development
and regulatory submission.

Phase 1 clinical activities for Nano-Mupirocin are scheduled to commence
in the third quarter of 2026, subject to the procurement of additional capital or grant funding. The initial study is designed to evaluate
the safety, tolerability, and pharmacokinetics of the candidate. While the clinical trial protocol has been finalized, the Company expects
to initiate the trial in Israel and/or South Africa, contingent upon regulatory and logistical factors.

In February 2026, the Company received regulatory
approval from the Israeli Ministry of Health. Additionally, a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug
Administration (FDA) is planned for the fourth quarter of 2026 – early 2027. Following completion of the Phase 1 trial, the resulting
data will be analyzed to establish the drug’s pharmacokinetic profile and inform the strategy for subsequent clinical development.

Management believes that this comprehensive plan
is designed to ensure that Nano-Mupirocin progresses systematically through manufacturing and clinical evaluation, adhering to regulatory
standards and providing the necessary data to support further development.

Competition

The pharmaceutical industry
is characterized by rapidly advancing technologies and intense competition and a strong emphasis on proprietary drugs. While we believe
that our knowledge, experience and scientific resources provide us with competitive advantages, we face potential competition from many
different sources, including large and specialty pharmaceutical and biotechnology companies, academic research institutions and governmental
agencies, as well as public and private research institutions. Any product candidates that we successfully develop and commercialize,
if approved, will compete with existing therapies and new therapies that may become available in the future.

The key competitive factors
affecting the success of all of our product candidates, if approved, are likely to be their safety, efficacy, convenience, price, the
level of generic competition, the existence of therapeutic alternatives and the availability of coverage and reimbursement from government
and other third-party payors.

Many of our competitors
have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting
clinical trials, obtaining regulatory approvals and marketing approved drugs than we do. Mergers and acquisitions in the pharmaceutical
and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller or
early-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large and established
companies. These competitors also compete with us in recruiting and retaining qualified scientific and management personnel and establishing
clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary
for, our programs. The current market for treatments that assist in novel therapeutics for major unmet medical needs, is highly unknown.
Our commercial opportunity would be reduced significantly if our competitors develop and commercialize products that are safer, more effective,
more convenient, have fewer side effects or are less expensive than our product candidates.

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Competition related to Nano Mupirocin

The global challenge of antibiotic resistance
has prompted significant efforts by pharmaceutical companies, biotechnology firms, and academic institutions to develop innovative therapeutic
solutions, including novel antibiotics, antibiotic combination therapies, bacteriophage therapies, antimicrobial peptides, and other non-traditional
antibacterial strategies. Our Nano-Mupirocin product candidate is being evaluated as a potential systemic therapy that leverages the known
antibacterial activity of mupirocin together with a novel liposomal delivery system. This approach may allow alternative distribution
and pharmacokinetic properties in preclinical models; however, this program remains in preclinical development, and there can be no assurance
that such characteristics will be observed in humans or that they will result in regulatory approval.

Among our direct competitors are companies advancing
new chemical entities (NCEs) that exhibit novel mechanisms of action against resistant bacteria, including Spero Therapeutics and Entasis
Therapeutics, which are developing innovative classes of antibiotics designed to target gram-negative bacteria, including those resistant
to carbapenems and third-generation cephalosporins. These new antibiotics aim to address critical gaps in current treatment options for
multidrug-resistant infections. The US-based startup Acurx Pharmaceuticals offers Ibezapolstat, their lead antibiotic candidate, for the
treatment of clostridium difficile infections. This antibiotic blocks the Pol 3IIIC enzymes in streptococcal, staphylococcal, and enterococcal
infections. The antibiotic also inhibits further DNA replication of CDI-causing pathogen and is currently undergoing Phase II trials.
Dutch startup AGILeBiotics creates novel antibiotics for the treatment of hospital-acquired infections such as ventilator acquired pneumonia,
bloodstream infections, and neonatal sepsis. Further, this startup develops treatment options for multi-drug resistant tuberculosis and
cystic fibrosis. Their Toframicin agent is currently undergoing preclinical development and is already delivering in-vitro results. The
US-based startup Geom Therapeutics, in partnership with a Korean biotechnology company LegoChem Biosciences, provides GT-1, a novel cephalosporin
class antibiotic. GT-1, with the help of a siderophore receptor, binds with iron and takes a trojan horse approach to attack the resistant
bacteria. The Global Antibiotic Research & Development Partnership (GARDP) in collaboration with Innoviva Specialty Therapeutics,
a subsidiary of Innoviva, Inc. (Nasdaq: INVA), recently announced that zoliflodacin, a clinically competitive candidate antibiotic, met
its primary endpoint in an global pivotal phase 3 clinical trial (for the treatment of gonorrhoea indication). Study investigators found
that oral zoliflodacin demonstrated statistical non-inferiority of microbiological cure at the urogenital site when compared to treatment
with intramuscular (IM) injection of ceftriaxone and oral azithromycin, a current global standard of care regimen. In the study, zoliflodacin
was found to be generally well tolerated and there were no serious adverse events or deaths recorded in the trial.

In addition to traditional small molecule antibiotics,
there is significant research and development activity in the field of antibiotic combination therapies. These are compounds that, when
used in combination with existing antibiotics, can enhance their efficacy, expand their spectrum of activity, or overcome resistance mechanisms.

VenatoRx Pharmaceuticals and Forge Therapeutics
are exploring beta-lactamase inhibitors and metalloenzyme inhibitors as potential combination therapys to restore the activity of beta-lactam
antibiotics against resistant strains.

Bacteriophage therapy represents another emerging
area of competition. This approach utilizes viruses that specifically target and kill bacteria, offering a highly selective alternative
to conventional antibiotics. Companies like Pherecydes Pharma and BiomX are at the forefront of developing phage-based therapies for indications
where antibiotic resistance is a significant concern, such as infections caused by MRSA and Pseudomonas aeruginosa.

Antimicrobial peptides (AMPs) and other non-traditional
antibacterial agents are also under development by companies like ContraFect Corporation and Polyphor AG. These agents offer novel modes
of action that differ from traditional antibiotics, potentially bypassing existing resistance mechanisms and providing new treatment avenues
for resistant infections.

In the realm of drug delivery technologies similar
to our liposomal formulation, companies like Matinas BioPharma and Encapsula NanoSciences are leveraging lipid-based nanoparticles and
other nanocarriers to improve the pharmacokinetics, safety, and efficacy of antimicrobial agents. These technologies aim to enhance drug
stability, reduce toxicity, and improve tissue penetration, offering potential competitive advantages over conventional formulations.

Furthermore, the ongoing discovery of new resistance
mechanisms and the genetic adaptability of pathogenic bacteria necessitate continuous innovation in the field of antimicrobial research.
Academic and government research institutions, often in collaboration with industry partners, are vital sources of novel antibacterial
strategies and could present future competitive threats or opportunities for collaboration.

37

Recent FDA approvals of oral therapies such as
zoliflodacin (Nuzolvence) and gepotidacin (Blujepa) for uncomplicated gonorrhea may expand treatment options in outpatient settings. However,
these therapies are primarily designed for uncomplicated infections and may have limitations in certain clinical scenarios, including
severe, invasive, or treatment-refractory cases.

We believe that there remains a potential need
for additional therapeutic options targeting more complex or resistant infections, particularly in hospital or high-acuity settings.

Given the ongoing risk of antimicrobial resistance,
including the potential for reduced susceptibility to newly approved agents over time, therapies with differentiated mechanisms may play
a role in future treatment paradigms. We are exploring the potential positioning of Nano-Mupirocin as a treatment option for complicated
infections where existing therapies may be insufficient or contraindicated; however, such positioning will depend on clinical outcomes,
regulatory approval, and market adoption.

The regulatory landscape for new antibacterial
agents is stringent, with a high emphasis on demonstrating not only efficacy and safety but also a clear advantage over existing therapies
in terms of resistance management and clinical outcomes. Our Nano-Mupirocin’s unique mechanism of action, broad-spectrum activity,
and enhanced delivery system position it as a promising candidate in this competitive environment. However, the success of Nano-Mupirocin
will depend on our ability to demonstrate its clinical benefits, safety profile, and cost-effectiveness relative to these emerging therapies.

While our Nano-Mupirocin product candidate is
being evaluated as a potential approach to addressing the critical issue of antibiotic resistance, it faces competition from a range of
traditional and non-traditional antibacterial therapies under development.

Our strategic positioning and ongoing innovation will be key to differentiating
Nano-Mupirocin in this diverse and evolving competitive landscape.

Competition related to ARB (AT1 receptor
blocker) novel cancer therapy combination therapy

We also face competition from a wide range of
pharmaceutical and biotechnology companies in the field of cancer therapy, particularly in the development of treatments targeting the
tumor microenvironment (TME) to enhance the efficacy of chemotherapy and immunotherapy. Many of these competitors are working on advanced
therapeutic strategies that include, but are not limited to, targeted therapies, immune checkpoint inhibitors, cancer vaccines, oncolytic
viruses, and cell therapies. These therapies aim to improve drug delivery, overcome TME-induced drug resistance, and modulate the immune
system’s response to cancer.

Several companies are developing liposomal formulations
and other nanoparticle-based delivery systems designed to improve the delivery and efficacy of cancer drugs, including Merrimack Pharmaceuticals
and Celator Pharmaceuticals, that have developed liposomal platforms for chemotherapeutic agents. These platforms aim to enhance drug
accumulation in tumor tissues while minimizing systemic toxicity, similar to our ARB’s intended mechanism of action.

Additionally, AstraZeneca, Roche, and Merck are
advancing the development of therapies targeting the TME, particularly focusing on modulating the immune microenvironment and overcoming
the immunosuppressive barriers within solid tumors. These efforts include the development of novel immune checkpoint inhibitors and agents
targeting CAFs, ECM remodeling enzymes, and other components critical to TME dynamics.

Emerging biotech firms are also exploring innovative
approaches to TME normalization, such as the use of small molecule inhibitors, monoclonal antibodies targeting CAFs or ECM components,
and gene therapy approaches to modulate the TME. These therapies aim to improve the penetration and effectiveness of existing cancer treatments
and may provide direct competition to our ARB technology.

On the technological front, advancements in nanotechnology,
drug formulation, and targeted delivery mechanisms, including the use of targeting ligands and stimuli-responsive release systems, present
potential competition. These technologies aim to enhance the selective accumulation and controlled release of therapeutics within the
TME, which is a key feature of our liposomal ARB formulation.

38

Furthermore, the use of angiotensin receptor blockers
(ARBs) in cancer therapy, while innovative, is not exclusive to our company. Research institutions and pharmaceutical companies are investigating
the repurposing of ARBs and other similar agents for oncological applications, given their potential anti-tumor effects. This could lead
to direct competition with our ARB product candidate, especially if these entities develop formulations or combinations that demonstrate
superior efficacy or safety profiles. However, while other methods of delivering ARBs orally or intravenously may lower blood pressure,
making them unsuitable for a large portion of cancer patients, the liposomal ARB has been demonstrated in animal models to be safe without
reducing blood pressure. This allows for its potential administration in a safe and efficacious manner.

The competitive landscape in oncology is highly
dynamic, with continuous advancements in science and technology leading to the emergence of novel therapeutic modalities. Regulatory approvals,
strategic partnerships, and market adoption of competing therapies could significantly impact the commercial potential of our ARB product
candidate.

While our proprietary Liposomal Protein-Loaded
Technology and the innovative use of ARB for TME normalization present a unique approach to cancer therapy, we acknowledge the presence
of significant competition from existing and forthcoming technologies aimed at improving the treatment of solid tumors. Our success will
depend on our ability to demonstrate superior efficacy, safety, and patient outcomes compared to these competing therapies.

Competition related to the novel vaccination
platform LPTP

The global race to develop effective vaccines
against Coronavirus has led to a highly competitive environment, with numerous pharmaceutical companies, biotech firms, and academic institutions
actively engaged in the creation of a variety of vaccine platforms. These include mRNA vaccines, viral vector vaccines, protein subunit
vaccines, and inactivated virus vaccines, among others. Each of these platforms has its own set of advantages and challenges, particularly
in terms of efficacy, safety, storage requirements, and ease of distribution.

Our liposomal booster vaccine, leveraging proprietary
Liposomal Protein-Loaded Technology, faces competition from several established and emerging vaccine technologies. Notably, mRNA vaccines
from companies like Pfizer-BioNTech and Moderna have received widespread approval and adoption due to their high efficacy rates and relatively
rapid development timelines. However, limitations related to cold-chain storage, distribution challenges, and the need for booster doses
to maintain immunity, especially against emerging variants, highlight areas where our technology could offer significant advantages.

Viral vector vaccines, such as those developed
by AstraZeneca-Oxford and Johnson & Johnson, also present competition. These vaccines have the advantage of stable storage temperatures
compared to mRNA vaccines but have faced challenges related to rare adverse events and variable efficacy rates across different populations
and virus variants.

Protein subunit vaccines, including those developed
by Novavax and Sanofi-GSK, offer a more traditional approach to vaccination and generally have a well-studied safety profile. These vaccines,
however, may also require combination therapies to enhance immune response and may face similar challenges in terms of scalability and
adaptability to new variants as our liposomal booster vaccine.

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In addition to these established platforms, several
companies and research institutions are exploring next-generation vaccine technologies, such as nanoparticle-based vaccines, DNA vaccines,
and intranasal vaccines. For example, companies like Vaxart are working on oral vaccines, while others, such as Altimmune, are developing
intranasal vaccines that could offer advantages in terms of administration and mucosal immunity, directly competing with the administration
route proposed for our liposomal booster vaccine.

Emerging technologies focusing on universal coronavirus
vaccines aim to provide broad protection against multiple strains and variants of coronaviruses, including SARS-CoV-2 and its variants.
This approach could potentially outpace the variant-specific booster strategy by offering long-lasting immunity across a wider array of
potential future threats.

The competitive landscape is further complicated
by the global nature of the Coronavirus pandemic, which requires vaccines not only to be effective and safe but also accessible and scalable
to meet the vast demands of different countries and populations. Regulatory approvals, strategic alliances, manufacturing capabilities,
and distribution networks will play crucial roles in the successful deployment of Coronavirus vaccines, including our liposomal booster
vaccine.

While our liposomal booster vaccine is expected
to offer distinct advantages in terms of durability, broad-spectrum immunity, minimal side effects, it enters a highly competitive and
rapidly evolving market. The success of our vaccine will depend on our ability to demonstrate superior efficacy, safety, and ease of use
compared to existing and forthcoming Coronavirus vaccines, as well as our capacity to navigate regulatory, manufacturing, and distribution
challenges in a timely manner in additional antiviral product development programs.

Intellectual Property

We strive to protect
the intellectual property that we believe is important to our business, including seeking and maintaining patent protection intended to
cover the composition of matter of our product candidates, their methods of use, their methods of production, related technologies and
other inventions. In addition to patent protection, we also rely on trade secrets to protect aspects of our business that are not amenable
to, or that we do not consider appropriate for, patent protection, including certain aspects of technical know-how.

Our commercial success
depends in part upon our ability to obtain and maintain patent and other proprietary protection for commercially important technologies,
inventions and know-how related to our business, defend and enforce our intellectual property rights, particularly our patent rights,
preserve the confidentiality of our trade secrets and operate without infringing valid and enforceable intellectual property rights of
others. We have discussed above our strategy with respect to the patent protection for each of our product candidates.

The patent positions
for companies like us are generally uncertain and can involve complex legal, scientific and factual issues. In addition, the coverage
claimed in a patent application can be significantly reduced before a patent is issued, and its scope can be reinterpreted and even challenged
after issuance. As a result, we cannot guarantee that any of our product candidates will be protectable or remain protected by enforceable
patents. We cannot predict whether the patent applications we are currently pursuing will issue as patents in any particular jurisdiction
or whether the claims of any issued patents will provide sufficient proprietary protection from competitors. Any patents that we hold
may be challenged, circumvented or invalidated by third parties.

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Regulation

Government Regulation

Government authorities at the federal, state and
local level in the United States and in other countries and jurisdictions, including UK, EU and chosen APAC countries, extensively regulate,
among other things, the research, development, testing, manufacture, pricing, reimbursement, sales, quality control, approval, packaging,
storage, recordkeeping, labeling, advertising, promotion, distribution, marketing, post-approval monitoring and reporting and import and
export of pharmaceutical products such as those we are developing.

We, along with our CMOs, CROs and third-party
vendors, will be required to satisfy these requirements in each of the countries in which we wish to conduct studies or seek approval
or licensure of our product candidates. The processes for obtaining marketing approvals in the United States and in foreign countries
and jurisdictions, along with subsequent compliance with applicable statutes, regulations, and other regulatory requirements, require
the expenditure of substantial time and financial resources.

Licensure and Regulation of Pharmaceutical Products in the United
States

Licensure and Regulation of Pharmaceutical Products in the United States

We are currently developing product candidates
that are regulated as pharmaceutical (drug) products. In the United States, the development, approval, and commercialization of pharmaceutical
products are governed primarily by the Federal Food, Drug, and Cosmetic Act (FDCA) and related regulations enforced by the U.S. Food and
Drug Administration (FDA). Drug development programs may ultimately proceed toward one of two primary FDA approval pathways under the
Food, Drug, and Cosmetic Act: Section 505(b)(1) or Section 505(b)(2). A 505(b)(1) application is used for new drugs with full reports
of safety and efficacy data from studies conducted by the applicant. In contrast, a 505(b)(2) application may permit, subject to FDA discretion,
the sponsor to rely in part on data not developed by them, such as published literature or data from an already approved drug, while still
submitting original clinical or preclinical data required to support the proposed changes—such as a new formulation, dosage form,
or indication. The 505(b)(2) pathway may be considered for product candidates involving reformulation or repositioning of existing drugs
and, while it could potentially reduce development time and cost, there can be no assurance that the FDA will permit its use or that it
will ultimately result in approval. In addition to the FDCA, pharmaceutical products are subject to various other federal, state, and
local laws and regulations.

41

Our product candidates are in early stages of
development and have not yet been approved for marketing or commercial distribution in the United States.

To obtain FDA approval to market and distribute
a new pharmaceutical product in the United States, a sponsor must successfully complete the following regulatory steps:

●
Preclinical Testing: Conduct laboratory and animal studies to evaluate pharmacology, toxicology, and formulation, in accordance with the FDA’s Good Laboratory Practice (GLP) regulations, where applicable.

●
Manufacturing Compliance: Develop and manufacture the drug substance and drug product in accordance with current Good Manufacturing Practice (cGMP) requirements, including analytical method validation, process validation, and stability testing.

●
Investigational New Drug (IND) Application: Submit an IND to the FDA to obtain authorization to initiate human clinical trials. The IND must include preclinical data, manufacturing information, and a proposed clinical trial protocol. The IND must become effective (30-day FDA review period) before human studies may commence.

●
Institutional Review Board (IRB) Approval: Obtain approval from an IRB for each clinical trial site before enrolling participants in any clinical study.

●
Clinical Trials: Conduct a series of well-controlled human clinical trials, in accordance with current Good Clinical Practice (cGCP) standards, to demonstrate the safety and efficacy of the product for each intended indication.

●
New Drug Application (NDA): Prepare and submit an NDA to the FDA, providing comprehensive data from preclinical and clinical studies, detailed manufacturing and quality control information, and proposed product labeling.

●
FDA Inspections: Undergo one or more inspections by the FDA of clinical trial sites, testing facilities, and manufacturing sites (including third-party contractors), to confirm compliance with cGMP, GLP, and cGCP standards, and to ensure data integrity and product quality.

●
User Fee Payment: Pay applicable user fees under the Prescription Drug User Fee Act (PDUFA), unless an exemption applies.

●
FDA Review and Approval: The FDA reviews the NDA and may convene an advisory committee for input. Approval is granted if the FDA determines that the product is safe and effective for its intended use, and that the manufacturing process ensures consistent product quality.

●
Post-Approval Commitments: If approved, the sponsor must comply with post-marketing requirements, which may include Risk Evaluation and Mitigation Strategies (REMS), Phase 4 (post-marketing) studies, periodic safety reporting, and continued compliance with cGMP and labeling regulations.

42

Failure to comply with the applicable requirements
at any time during the product development process, including preclinical testing, clinical testing, the approval process, or post-approval
process, may subject an applicant to delays in the conduct of the study or regulatory review and approval, as well as administrative or
judicial sanctions or other consequences. These sanctions or consequences may include, but are not limited to, the FDA’s refusal
to allow an applicant to proceed with clinical testing, issuance of clinical holds for planned or ongoing studies, refusal to approve
pending applications, suspension or revocation of existing product licenses or approvals, issuance of warning or untitled letters, adverse
publicity, product recalls, marketing restrictions, product seizures, import detentions and refusals, total or partial suspension of manufacturing
or distribution, injunctions, fines and civil or criminal investigations and penalties brought by the FDA or the Department of Justice
(“DOJ”), and other governmental entities, including state agencies.

Preclinical Studies and Investigational New Drug Application

Once a therapeutic product candidate is identified
for development, it must undergo preclinical studies (also known as preclinical testing) before any testing may be conducted in humans.
Preclinical tests include laboratory evaluations of product chemistry, formulation and stability, as well as studies to evaluate the potential
for efficacy and toxicity in animals. The conduct of preclinical tests and formulation of the compounds for testing must comply with federal
regulations and requirements, including GLPs. The results of the preclinical tests, together with manufacturing information, analytical
data, and plans for the proposed clinical studies, are submitted to the FDA as part of an IND. Some preclinical testing may continue after
an IND is submitted.

An IND is a request for FDA authorization to administer
an investigational new drug product to humans. The IND automatically becomes effective 30 days after receipt by the FDA, unless before
that time the FDA raises concerns or questions about the product or the conduct of the proposed clinical trial, including concerns that
human research subjects will be exposed to unreasonable health risks. In that case, the IND sponsor and the FDA must resolve any outstanding
FDA concerns before the clinical trials can begin. As a result, submission of an IND may or may not result in FDA authorization to begin
a clinical trial, or to begin a clinical trial on the terms originally specified by the sponsor in the IND.

At any time during the initial 30-day IND review
period or while clinical trials are ongoing under the IND, the FDA may impose a partial or complete clinical hold. Clinical holds may
be imposed by the FDA when there is concern for patient safety, and may be a result of new data, findings, or developments in clinical,
preclinical, and/or chemistry, CMC or where there is non-compliance with regulatory requirements. This order would delay either a proposed
clinical trial or cause suspension of an ongoing trial, until all outstanding concerns have been adequately addressed and the FDA has
notified the company that investigations may proceed. A separate submission to an existing IND must also be made for each successive clinical
trial conducted, and the FDA must grant permission, either explicitly or implicitly, by not objecting before each clinical trial can begin.

Human Clinical Trials

Clinical trials involve the administration of
an investigational drug product to healthy volunteers or patients with the disease or condition to be treated under the supervision of
qualified investigators. Clinical trials must be conducted in accordance with GCPs, which establish ethical and data integrity standards
for clinical testing, as well as the requirements for informed consent.

Clinical trials are conducted under protocols
detailing, among other things, the objectives of the trial, dosing procedures, inclusion and exclusion criteria, the parameters to be
used in monitoring safety, and the effectiveness criteria to be evaluated. A protocol for each clinical trial and any subsequent protocol
amendments must be submitted to the FDA as part of the IND.

For clinical trials conducted in the United States,
an IND is required, and each clinical trial must be reviewed and approved by an IRB either centrally or individually at each institution
at which the clinical trial will be conducted. The IRB will consider, among other things, clinical trial design, patient informed consent,
ethical factors, the safety of human subjects and the possible liability of the institution. An IRB must operate in compliance with FDA
regulations.

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The FDA, IRB or the trial sponsor may suspend
a clinical trial at any time on various grounds, including a finding that the trial is not being conducted in accordance with GCPs or
IRB requirements or that research subjects or patients are being exposed to an unacceptable health risk. In addition, some clinical trials
are overseen by an independent group of qualified experts organized by the sponsor, known as a data safety monitoring board or data monitoring
committee. Depending on its charter, this group may recommend continuation of the trial as planned, changes in trial conduct, or cessation
of the trial at designated check points based on certain available data from the trial.

A sponsor who wishes to conduct a clinical trial
outside the United States may, but need not, obtain FDA authorization to conduct the clinical trial under an IND. When a foreign clinical
trial is conducted under an IND, all FDA IND requirements must be met unless waived. When a foreign clinical trial is not conducted under
an IND, FDA may accept the results of the study in support of a BLA if the study was well-designed and conducted in accordance with GCPs,
and the FDA is able to validate the data through an onsite inspection if deemed necessary.

Clinical trials typically are conducted in three
sequential phases, but the phases may overlap or be combined. Additional studies may be required after approval.

●
Phase 1 clinical trials are initially conducted in a limited population of healthy subjects to test the product candidate for safety, including adverse effects, dose tolerance, absorption, metabolism, distribution, excretion and PD. In the case of some products designed to address severe or life-threatening diseases, initial human testing is often conducted in patients with the disease, especially when the product may be too inherently toxic to ethically administer to healthy volunteers.

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Phase 2 clinical trials are generally conducted in a limited patient population to identify possible adverse effects and safety risks, evaluate the preliminary efficacy of the product candidate for specific targeted indications and determine dose tolerance and recommended dosage. Multiple Phase 2 clinical trials may be conducted by the sponsor to obtain information prior to beginning larger and more costly Phase 3 clinical trials.

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Phase 3 clinical trials are typically conducted to further refine dosage regimens, generate substantial evidence of clinical efficacy, and expand the safety database by evaluating the investigational product in a broader and more diverse patient population across multiple, geographically dispersed clinical trial sites. These trials are generally well-controlled and statistically powered to support regulatory decision-making regarding product approval and labeling.

Such studies are commonly referred to
as “pivotal trials,” as they are designed to provide the definitive data required by regulatory authorities to assess the
risk-benefit profile of the product. However, in certain cases, such as for investigational products targeting rare diseases with Orphan
Drug Designation, a Phase 2 trial may be deemed pivotal if it is sufficiently robust to provide the clinical evidence necessary to support
targeted marketing application.

While the IND is active and before approval, progress
reports detailing the results of the clinical trials and preclinical studies performed since the last progress report must be submitted
at least annually to the FDA and written IND safety reports must be submitted to the FDA and the investigators for serious and unexpected
suspected adverse events, findings from other studies or animal or in vitro testing that suggest a significant risk for
human subjects and any clinically important increase in the rate of a serious suspected adverse reaction over that listed in the protocol
or investigator brochure. The sponsor must submit an IND safety report within 15 calendar days after the sponsor determines that the information
qualifies for reporting. The sponsor also must notify the FDA of any unexpected fatal or life-threatening suspected adverse reaction within
seven calendar days after the sponsor’s initial receipt of the information.

There are also requirements governing the reporting
of ongoing clinical trials and clinical trial results to public registries. Sponsors of certain clinical trials of FDA-regulated products
are required to register and disclose information about ongoing clinical trials, including information related to the drug, patient population,
phase of investigation, trial sites and investigators. Sponsors are also obligated to disclose the results of completed clinical
trials, other than Phase 1 clinical trials, within specific timeframes. Information about applicable clinical trials is published
on www.ClinicalTrials.gov, a clinical trials database maintained by the National Institute of Health (NIH).

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During the development of a new pharmaceutical
product, sponsors are given opportunities to meet with the FDA at certain points. These points may be prior to submission of an IND, at
the end of Phase 2, and before an NDA is submitted. Meetings at other times may be requested. These meetings can provide an opportunity
for the sponsor to share information about the data gathered to date, for the FDA to provide advice, and for the sponsor and the FDA to
reach agreement on the next phase of development.

Compliance with cGMPs

Concurrent with clinical trials, companies must
finalize a process for manufacturing the product in commercial quantities in accordance with cGMPs. The manufacturing process must be
capable of consistently producing quality batches of the product and, among other things, companies must develop methods for testing the
identity, strength, quality and purity of the final product. Additionally, appropriate packaging must be selected and tested and stability
studies must be conducted to demonstrate that the products do not undergo unacceptable deterioration over their shelf life. Before approving
a New Drug Application ( NDA), the FDA will typically inspect the facility or facilities where the product is manufactured. The FDA will
not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMPs and adequate
to assure consistent production of the product within required specifications. Material changes in manufacturing equipment, location,
or process post-approval, may result in additional regulatory review and approval.

Review and Approval of an NDA

The results of clinical trials and preclinical
studies, together with detailed information regarding the manufacturing processes, chemistry and composition of the product, the proposed
labeling and other relevant information, are submitted to the FDA as part of an NDA requesting approval to market the product for one
or more specified indications. Clinical and preclinical data may come from company-sponsored trials or from a number of alternative sources,
including studies initiated by investigators, and the NDA must include any negative and ambiguous results, as well as positive results.
To support marketing approval, the data submitted must be sufficient in quality and quantity to establish the safety, purity, and potency
of the investigational product to the satisfaction of the FDA. For most NDAs, the sponsor is required to pay a substantial application
user fee at the time of submission and the sponsor of an approved NDA is subject to an annual program fee. Certain exceptions and waivers
are available for some of these fees, such as an exception from the application fee for products with orphan designation and a waiver
for certain small businesses.

The FDA has 60 days after submission of the
application to conduct an initial review to determine whether to accept it for filing based on the agency’s threshold determination
that it is sufficiently complete to permit substantive review. If the submission has been accepted for filing, the FDA begins an in-depth
review of the application. Under the goals and policies agreed to by the FDA under PDUFA, the FDA has ten months from the filing
date in which to complete its initial review of a standard application and respond to the applicant, and six months for a priority
review of the application. The FDA does not always meet its PDUFA goal dates for standard and priority NDAs and the review process may
be significantly extended by FDA requests for additional information or clarification.

During its review of a NDA, the FDA may refer
applications for novel pharmaceutical products that present difficult questions of safety or efficacy to an advisory committee. Typically,
an advisory committee is a panel of independent experts, including clinicians and other scientific experts, that reviews, evaluates and
provides a recommendation as to whether the application should be approved and under what conditions, if any. The FDA is not bound by
the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions. Accordingly, there
can be no assurance that a favorable advisory committee recommendation, if obtained, will result in FDA approval.

On the basis of the FDA’s evaluation of
the application and accompanying information, including the results of the inspection of the manufacturing facilities and any FDA audits
of preclinical and clinical trial sites to assure compliance with GLPs or GCPs, the FDA may approve the NDA or issue a complete response
letter. A complete response letter may require additional clinical data and/or other significant and time-consuming requirements related
to clinical trials, preclinical studies or manufacturing. Sponsors that receive a complete response letter have one year to submit information
that represents a complete response to the deficiencies identified by the FDA. The FDA will then re-review the application, taking into
consideration the response, and determine whether the application meets the criteria for approval. Failure to respond to a complete response
letter will serve as a withdrawal of an application. The FDA will not approve an application until issues identified in any complete response
letters have been addressed.

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If the FDA approves a new product, it may limit
the approved indication(s) for use of the product. It may also require that contraindications, warnings, or precautions be included in
the product labeling. In addition, the FDA may require post-approval studies, including Phase 4 clinical trials, to further assess
the product’s efficacy and/or safety after approval. The agency may also require testing and surveillance programs to monitor the
product after commercialization, or impose other conditions, including distribution restrictions or other risk management mechanisms.
The FDA may prevent or limit further marketing of a product based on the results of post-market studies or surveillance programs.

After approval, if there are any modifications
to the approved product, including changes in the indications, dosage forms, labeling, or manufacturing processes or facilities, the sponsor
may be required to submit and obtain FDA approval of a new NDA or NDA supplement, which may require the generation of additional data
or the conduct of additional preclinical studies and clinical trials.

Post-Approval Regulation

Upon FDA approval of a NDA, the sponsor is required
to comply with all applicable post-approval regulatory requirements for pharmaceutical products, including any specific conditions imposed
by the FDA as part of the approval for the product or its indicated use. The sponsor will be required to report certain adverse reactions
and production problems to the FDA, provide updated safety and efficacy information, obtain FDA approval for certain manufacturing and
labeling changes, and comply with requirements concerning advertising and promotional labeling, record-keeping, and drug supply chain
security. Manufacturers and certain of their subcontractors are required to register their establishments with the FDA and certain state
agencies and are subject to periodic unannounced inspections for compliance with ongoing regulatory requirements, including cGMPs. Accordingly,
the sponsor and its third-party manufacturers must continue to expend time, money and effort in the areas of production and quality control,
as well as pharmacovigilance activities, to maintain compliance with cGMPs and other regulatory requirements.

Post NDA regulations include, among other things,
standards and regulations for direct-to-consumer advertising, communications regarding unapproved uses, industry-sponsored scientific
and educational activities and promotional activities involving the internet and social media. Promotional claims about a drug’s
safety or effectiveness are prohibited before the NDA is approved. Once a NDA is approved, the sponsor can make only those claims relating
to safety, efficacy, purity and potency that are in accordance with the provisions of the approved label. In the United States, healthcare
professionals are generally permitted to prescribe legally available drugs for uses that are not described in the product’s labeling
and that differ from those approved by the FDA. Such off-label uses are common across medical specialties. The FDA does not regulate the
practice of medicine or healthcare providers’ choice of treatments. However, FDA regulations do impose rigorous restrictions on
manufacturers’ communications of off-label uses. Additionally, promotional materials for prescription drug products must be submitted
to the FDA in conjunction with their first use.

The FDA may require testing and surveillance programs
to monitor the effect of approved products that have been commercialized, and the FDA has the power to prevent or limit further marketing
of a product based on the results of these post-marketing programs.

The FDA may withdraw product approval if compliance
with regulatory requirements and standards is not maintained or if issues occur after the product reaches the market. Later discovery
of previously unknown issues with a product, including adverse events of unanticipated severity or frequency, or with manufacturing processes,
or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition
of post-market studies or clinical trials to assess new safety risks; or imposition of distribution or other restrictions and consequences
including:

●
restrictions on the marketing or manufacturing of the product, including total or partial suspension of production, or complete withdrawal of the product from the market;

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the issuance of safety alerts, Dear Healthcare Provider letters, press releases or other

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refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of product license approvals;

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product recall, seizure or detention, or refusal to permit the import or export of products;

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imposition of clinical holds on ongoing clinical trials;

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mandated modification of promotional materials and labeling and the issuance of corrective information;

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consent decrees, corporate integrity agreements, debarment or exclusion from federal

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fines, injunctions or the imposition of civil or criminal penalties.

Fast Track, Breakthrough Therapy and Priority Review Designations

The FDA has several programs intended to facilitate
and expedite development and review of new products that are intended to address an unmet medical need in the treatment of a serious or
life-threatening disease or condition. These programs are referred to as fast track designation, breakthrough therapy designation and
priority review designation. These designations are not mutually exclusive, and a product candidate may qualify for one or more of these
programs. While these programs are intended to expedite product development and approval, they do not alter the standards for FDA approval.

The FDA may designate a product for fast track
designation if it is intended for the treatment of a serious or life-threatening disease or condition, and preclinical or clinical data
demonstrate the potential to address unmet medical needs for such a disease or condition. For products with fast track designation, sponsors
may have more frequent interactions with the FDA, the product is potentially eligible for accelerated approval and priority review, if
relevant criteria are met. and the NDA may be eligible for “rolling review,” under which the FDA may consider sections of
the NDA for review on a rolling basis before the complete application is submitted. This rolling review may be available if the FDA determines,
after preliminary evaluation of clinical data submitted by the sponsor, that a product with fast track designation may be effective. The
sponsor must also provide, and the FDA must approve, a schedule for the submission of the remaining sections of the NDA, and the sponsor
must pay any required user fees upon submission of the first section of the NDA. The FDA’s time goal for reviewing a fast track
application does not begin until the last section of the application is submitted.

A product may be designated as a breakthrough
therapy if it is intended to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that
the product may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. The designation
includes all of the fast track program features, including eligibility for rolling review. Additionally, the FDA may take certain actions
to expedite the development and review of breakthrough therapies, including holding meetings with the sponsor throughout the development
process; providing timely advice to the product sponsor regarding development and approval; involving more senior staff managers in the
review process; assigning a cross-disciplinary lead for the review team; and taking other steps to design the clinical trials in an efficient
manner.

The FDA may designate a product for priority review
if it is a product that treats a serious condition and, if approved, would provide a significant improvement in safety or effectiveness
when compared with other available therapies. A priority review designation is intended to direct the FDA’s attention and resources
to the evaluation of such applications, and to shorten the FDA’s goal for taking action on an original NDA from ten months
to six months from the filing date.

Fast track designation, breakthrough therapy designation,
and priority review do not change the standards for approval but may expedite the development or approval process. Even if a drug qualifies
for one or more of these programs, the FDA may later withdraw or rescind the designation if it decides that the drug no longer meets the
conditions for qualification or decides that the time period for FDA review or approval will not be shortened.

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Accelerated Approval Pathway

The FDA may grant accelerated approval to a product
candidate designed to treat a serious or life-threatening condition that provides a meaningful therapeutic advantage to patients over
existing treatments based upon a determination that the product has an effect on a surrogate endpoint that is reasonably likely to predict
clinical benefit. For the purposes of accelerated approval, a surrogate endpoint is a marker, such as a laboratory measurement, radiographic
image, physical sign, or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The
FDA may also grant accelerated approval for such a condition when the product has an effect on an intermediate clinical endpoint that
can be measured earlier than an effect on irreversible morbidity or mortality (“IMM”), and that is reasonably likely to predict
an effect on IMM or other clinical benefit, taking into account the severity, rarity or prevalence of the condition and the availability
or lack of alternative treatments.

The accelerated approval pathway is most often
used in settings in which the course of a disease is long, and an extended period of time is required to measure the intended clinical
benefit of a product, even if the effect on the surrogate or intermediate clinical endpoint occurs rapidly. Products granted accelerated
approval must meet the same statutory standards for safety and effectiveness as those granted traditional approval.

The FDA’s approval of a candidate product
under the accelerated approval pathway is usually contingent on a sponsor’s agreement to conduct post-approval confirmatory studies
to verify and describe the product’s clinical benefit, and the FDA may require such studies to be underway prior to approval. Failure
to conduct required post-approval studies, confirm a clinical benefit during post-marketing studies may result in the FDA’s withdrawal
of the product from the market on an expedited basis. All promotional materials for therapeutic candidates approved under accelerated
regulations are subject to prior review by the FDA.

Orphan Drug Designation and Exclusivity

Orphan drug designation in the United States is
designed to encourage sponsors to develop products intended for treatment of rare diseases or conditions. In the United States, a rare
disease or condition is statutorily defined as a condition that affects fewer than 200,000 individuals in the United States or that affects
200,000 or more individuals in the United States and for which there is no reasonable expectation that the cost of developing and making available
the drug or biologic for the disease or condition will be recovered from sales of the product in the United States.

Orphan drug designation qualifies a company for
tax credits and market exclusivity for seven years following the date of the product’s marketing approval if granted by the
FDA. An application for designation as an orphan product can be made any time prior to the filing of an application for approval to market
the product. If orphan drug designation is granted by the FDA, the generic identity of the therapeutic agent and its potential orphan
use are disclosed publicly by the FDA. After FDA grants orphan designation, the product must then go through the review and approval process
like any other product.

A sponsor may request orphan drug designation
of a previously unapproved product or new orphan indication for an already marketed product. In addition, a sponsor of a product that
is otherwise the same product as an already approved orphan drug may seek and obtain orphan drug designation for the subsequent product
for the same rare disease or condition if it can present a plausible hypothesis that its product may be clinically superior to the first
drug. More than one sponsor may receive orphan drug designation for the same product for the same rare disease or condition, but each
sponsor seeking orphan drug designation must file a complete request for designation.

If a product with orphan designation receives
the first FDA approval for the disease or condition for which it has such designation or for a select indication or use within the rare
disease or condition for which it was designated, the product generally will receive orphan drug exclusivity. Orphan drug exclusivity
means that the FDA may not approve another sponsor’s marketing application for the same product for the same indication for seven years,
except in certain limited circumstances. If a product designated as an orphan drug ultimately receives marketing approval for an indication
broader than what was designated in its orphan drug application, it may not be entitled to exclusivity. Orphan drug exclusivity does not
prevent the FDA from approving a different drug for the same disease or condition, or the same drug for a different disease or condition.

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The period of exclusivity begins on the date that
the marketing application is approved by the FDA and applies only to the indication for which the product has been designated. The FDA
may approve a second application for the same product for a different use or a second application for a clinically superior version of
the product for the same use. The FDA cannot, however, approve the same product made by another manufacturer for the same indication during
the market exclusivity period unless it has the consent of the sponsor, or the sponsor is unable to provide sufficient quantities.

The FDA has historically interpreted orphan drug
exclusivity as applying only to the specific approved indication, not the entire disease for which the orphan designation was granted.
However, in Catalyst Pharmaceuticals, Inc. v. Becerra (2021), the Eleventh Circuit ruled that exclusivity should cover all uses
within the designated orphan disease, rejecting the FDA’s narrower interpretation. In response, the FDA announced in January 2023
that it would follow the court’s ruling only within the Eleventh Circuit’s jurisdiction and maintain its longstanding approach
elsewhere. As a result, the scope of orphan drug exclusivity in the U.S. remains uncertain and may be further shaped by future litigation
or legislative action.

Development in Pediatric Patients

Under the Pediatric Research Equity Act of 2003,
a NDA must contain data that are adequate to assess the safety and effectiveness of the product for the claimed indications in all relevant
pediatric subpopulations and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective.
A sponsor who is planning to submit a marketing application for a product that includes a new active ingredient, new indication, new dosage
form, new dosing regimen or new route of administration must submit a Pediatric Study Plan (“PSP”) that contains an outline
of the proposed pediatric study or studies the applicant plans to conduct, including study objectives and design, any deferral or waiver
requests and other information required by regulation. The sponsor and the FDA must reach agreement on the PSP. The FDA or the applicant
may request an amendment to the plan at any time.

The FDA may, on its own initiative or at the request
of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in adults,
or full or partial waivers from the pediatric data requirements. The FDA must send a non-compliance letter to any sponsor that fails to
submit the required assessment, keep a deferral current or fails to submit a request for approval of a pediatric formulation. Unless otherwise
required by regulation, the pediatric data requirements do not apply to products with orphan designation.

Pediatric Exclusivity

Pediatric exclusivity is a type of non-patent
marketing exclusivity in the United States and, if granted, provides for the attachment of an additional six months of marketing
protection to the term of any existing regulatory exclusivity, including orphan exclusivity. This six-month exclusivity may be granted
if a NDA sponsor submits pediatric data that fairly respond to a written request from the FDA for such data. The data do not need to show
the product to be effective in the pediatric population studied; rather, if the clinical trial is deemed to fairly respond to the FDA’s
request, the additional protection is granted.

U.S. Patent Term Restoration and Extension

In the United States, a patent claiming a new
biologic product, its method of use or its method of manufacture may be eligible for a limited patent term extension under the Hatch-Waxman
Amendments, which permits a patent extension of up to five years for patent term lost during product development and FDA regulatory
review. Assuming grant of the patent for which the extension is sought, the restoration period for a patent covering a product is
typically one-half the time between the effective date of the IND and the submission date of the NDA, plus the time between the submission
date of the NDA and the ultimate approval date, except that the review period is reduced by any time during which the applicant failed
to exercise due diligence. Patent term restoration cannot be used to extend the remaining term of a patent past a total of 14 years
from the product’s approval date in the United States. Only one patent applicable to an approved product is eligible for the extension,
and the application for the extension must be submitted prior to the expiration of the patent for which extension is sought. A patent
that covers multiple products for which approval is sought can only be extended in connection with one of the approvals. The USPTO reviews
and approves the application for any patent term extension in consultation with the FDA.

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Regulation and Procedures Governing Approval of Medicinal Products
in Europe

In order to market any medicinal product outside
of the United States, a company must also comply with numerous and varying regulatory requirements to generate relevant data for the purpose
of establishing its quality, safety and efficacy. There are specific rules governing, among other things, clinical trials, marketing authorization,
commercial sales and distribution of products. Regardless of the product approval status in the United States, an applicant will need
to obtain the necessary approvals granted by the comparable foreign regulatory authorities before it can commence clinical trials or marketing
of a medicinal product in those countries or jurisdictions.

The processes governing approval of medicinal
products in the EU and UK generally adopt a similar approach to that applied in the United States. They entail satisfactory completion
of preclinical studies and adequate and well-controlled clinical trials to establish the safety and efficacy of the product for each proposed
indication. Data should be generated to demonstrate that a drug substance and a drug product can be manufactured and controlled according
to the pre-specified quality standards. The data relating to quality, preclinical testing and clinical trials should be submitted to the
relevant competent authorities in a marketing authorization application (“MAA”) for regulatory review in order to determine
whether a marketing authorization can be granted. Even if a marketing authorization has been granted, there is a need to obtain a pricing
and reimbursement decision before a new medicinal product can be marketed and sold in the EU and/or the UK (as applicable).

Clinical Trial Approval

Pursuant to the currently applicable Regulation
(EU) No 536/2014 (CTR) and Directive 2005/28/EC on GCP, an applicant must obtain approval from the national competent authority of an
EU member state in which the clinical trial is to be conducted, or in multiple member states if the clinical trial is to be conducted
in a number of member states. Furthermore, the applicant can only start a clinical trial at a specific site after a research ethics committee
has issued a favorable opinion. The clinical trial application must be accompanied by an investigational medicinal product dossier with
supporting information prescribed by the CTR and corresponding national laws of the member states. All suspected unexpected serious adverse
reactions to the investigational medicinal product that occur during the clinical trial have to be reported to the national competent
authorities and research ethics committees of the member state where they occurred.

Pursuant to the CTR, a sponsor must submit a single
application for a new clinical trial authorization through a centralized EU clinical trials portal called the Clinical Trials Information
System (“CTIS”). One national competent authority (from the reporting EU member state selected by the applicant) takes the
lead in validating and evaluating the application, as well as consulting and coordinating with the other concerned member states in which
the clinical trial is to be conducted. If an application is rejected, it may be amended and resubmitted through CTIS. A concerned member
state may in limited circumstances declare an “opt-out” from an approval and prevent the clinical trial from being conducted
in that member state. As of January 31, 2025, all ongoing trials approved under the CTD must comply with the CTR and information
relating to such clinical trials must be recorded in CTIS. The CTR aims to streamline and simplify the rules on safety reporting, and
introduces enhanced transparency requirements such as mandatory submission of a summary of the clinical trial results to the CTIS.

The UK formally left the EU on January 31,
2020, under the terms of the Agreement on the withdrawal of the UK of Great Britain and Northern Ireland from the EU and the European
Atomic Energy Community (the EU-UK Withdrawal Agreement). Despite this, EU law continued to apply in the UK until the expiry of the transition
period on 31 December 2020. Following the UK’s departure from the EU, the UK and the EU entered into a trade and cooperation
agreement (“TCA”), which includes specific provisions concerning pharmaceuticals (such as the mutual recognition of cGMP inspections
of manufacturing facilities for medicinal products and cGMP documents issued), but which does not provide for wholesale mutual recognition
of UK and EU pharmaceutical regulations. At the point that the transition period expired, the Northern Ireland Protocol, which is contained
in the EU-UK Withdrawal Agreement, took effect. The Northern Ireland Protocol makes certain provisions of EU law, including several concerning
medicinal products, applicable in Northern Ireland. This position has recently been revised via the Windsor Framework. Under the Windsor
Framework, from January 1, 2025, all new medicinal products for the UK market will be authorized by the UK’s Medicines and
Healthcare products Regulatory Agency (“MHRA”) (see further below).

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In the UK, clinical trials of medicinal products
are primarily governed by the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended (the UK Regulations). The UK
Regulations sought to implement the CTD while the UK was a member state of the EU. Since the CTR was not in force in the EU at the time
when the UK exited the EU, it was not retained in UK law on exit day under the terms of the European Union (Withdrawal) Act 2018. Following
a public consultation which was conducted in early 2022, the UK authorities are in the process of developing legislation which seeks to
improve and strengthen the clinical trials regulatory regime in the UK. The extent to which the regulation of clinical trials in the UK
will mirror the CTR is unknown at present.

Accelerated Assessment Pathways

The EU’s Priority Medicines (“PRIME”)
scheme is intended to encourage drug development in areas of unmet medical need and facilitates accelerated assessment of medicinal products
representing substantial innovation reviewed under the centralized procedure. Eligible products must target conditions for which there
is an unmet medical need (there is no satisfactory method of diagnosis, prevention or treatment in the EEA or, if there is, the new medicine
will bring a major therapeutic advantage) and they must demonstrate the potential to address the unmet medical need by, for example, introducing
new methods of therapy or improving existing ones. Products from small- and medium-sized enterprises may qualify for earlier entry into
the PRIME scheme. Many benefits accrue to sponsors of therapeutic candidates with PRIME designation, including but not limited to, early
and proactive regulatory dialogue with the EMA, frequent discussions on clinical trial designs and other development program elements,
and accelerated MAA assessment once a dossier has been submitted. Importantly, an EMA contact and rapporteur from the Committee for Human
Medicinal Products (“CHMP”), or Committee for Advanced Therapies are appointed early in the PRIME scheme facilitating increased
understanding of the product at the EMA’s Committee level. A kick-off meeting initiates these relationships and includes a team
of multidisciplinary experts at the EMA to provide guidance on the overall development and regulatory strategies. Where, during the course
of development, a medicine no longer meets the eligibility criteria, support under the PRIME scheme may be withdrawn.

The UK’s Innovative Licensing and Access
Pathway (“ILAP”) aims to accelerate the time to market of innovative medicinal products. It is open to both commercial and
non-commercial applicants, who are based in the UK or global, and who are developing medicinal products which include products containing
new chemical entities, biological medicinal products, new indications and repurposed medicinal products. It comprises of an Innovation
Passport designation and a Target Development Profile, and provides applicants with access to a toolkit to support all stages of the design,
development and approvals process. The major benefit of the ILAP scheme is that it provides applicants with opportunities for enhanced
regulatory and stakeholder input during the development of their medicinal products.

Marketing Authorization

To obtain a marketing authorization for a medicinal
product under the EU regulatory system, an applicant must submit an MAA, either under a centralized procedure administered by the EMA
or one of the procedures administered by competent authorities in EU member states (decentralized procedure, national procedure, or mutual
recognition procedure). A marketing authorization may be granted only to an applicant established in the EU.

Regulation (EC) No 1901/2006 provides that prior
to obtaining a marketing authorization in the EU, an applicant must demonstrate compliance with all measures included in an EMA-approved
Pediatric Investigation Plan (“PIP”), covering all subsets of the pediatric population, unless the EMA has granted a product-specific
waiver, class waiver or a deferral for one or more of the measures included in the PIP. The Pediatric Committee of the EMA (“PDCO”),
may grant deferrals for some medicines, allowing a company to delay development of the medicine for children until there is enough information
to demonstrate its effectiveness and safety in adults. The PDCO may also grant waivers when development of a medicine for children is
not needed or is not appropriate, such as for diseases that only affect the elderly population. An application for marketing authorization
or a variation or a variation or a line-extension which is accompanied by the pediatric clinical trials conducted in accordance with the
PIP (even where such results are negative) are eligible for a six months extension of their supplementary protection certificate.
In the case of orphan medicinal products, a two-year extension of the orphan market exclusivity may be available. This pediatric reward
is not automatically available and is subject to the EMA or the relevant national competent authorities confirming compliance with the
agreed PIP that may require an opinion to be given by the EMA’s Pediatric Committee.

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The centralized procedure provides for the grant
of a single marketing authorization by the European Commission that is valid for all EU member states, as well as the additional member
states of the EEA (Norway, Iceland and Liechtenstein). The centralized procedure is optional for products containing a new active substance
which was not authorized in the EU on May 20, 2004, or for products that constitute a significant therapeutic, scientific or technical
innovation or which are in the interest of public health in the EU. An applicant for the centralized MA must demonstrate the quality,
safety and efficacy of their products to the EMA for an opinion to be adopted regarding the approvability of the MAA. The European Commission
grants or refuses marketing authorization in light of the opinion delivered by the EMA.

Under the centralized procedure, the CHMP established
within the EMA is responsible for conducting an initial assessment of a medicinal product. The maximum timeframe for the evaluation of
an MAA is 210 days, excluding clock stops when additional information or written or oral explanation is to be provided by the applicant
in response to questions of the CHMP. Clock stops may extend the timeframe of evaluation of an MAA considerably beyond 210 days.
Where the CHMP gives a positive opinion, the EMA provides the opinion together with supporting documentation to the European Commission,
who make the final decision to grant a marketing authorization, which is issued ordinarily within 67 days of receipt of the EMA’s
recommendation. Accelerated evaluation may be granted by the CHMP in exceptional cases, when a medicinal product is of major interest
from the point of view of public health and, in particular, from the viewpoint of therapeutic innovation. If the CHMP accepts such a request,
the time limit of 210 days will be reduced to 150 days (excluding clock stops), but it is possible that the CHMP may revert
to the standard time limit for the centralized procedure if it determines that it is no longer appropriate to conduct an accelerated assessment.

National marketing authorizations, which are issued
by the national competent authorities of the member states of the EEA and only cover their respective territory, are available for products
not falling within the mandatory scope of the centralized procedure. Where a medicinal product has already been authorized for marketing
in a member state of the EEA, this national authorization can be recognized in other member states through the mutual recognition procedure.
If the product has not received a national authorization in any member state at the time of application, it can be approved simultaneously
in two or more member states through the decentralized procedure.

Following its departure from the EU, the UK has
introduced changes to its national licensing procedures, including procedures to prioritize access to new medicines that will benefit
patients, ILAP (described above) and new routes of evaluation for novel products and biotechnological products. Notwithstanding that there
is no wholesale recognition of EU pharmaceutical legislation under the TCA, and that EU marketing authorizations do not automatically
provide a valid basis for the commercialization of medicinal products in Great Britain from January 1, 2024, applicants will be able
to request the MHRA to recognize marketing authorizations granted in foreign jurisdictions (including the EU) under a new International
Recognition Procedure.

Patent Term Extensions in the EU and Other Jurisdictions

The EU also provides for patent term extension
through SPCs which aim to offset the loss of patent protection for pharmaceutical products arising from the lengthy testing and clinical
trials required to obtain an MA. The rules and requirements for obtaining a SPC are similar to those in the United States. An SPC may
extend the term of a basic patent for up to five years after its originally scheduled expiration date in order to provide up to a
maximum of fifteen years of exclusivity from the time the medicinal product in question first obtains an MA for it to be placed on
the market. As mentioned above, in certain circumstances, these periods may be extended for six additional months if pediatric exclusivity
is obtained; and in the case of orphan medicinal products, a two-year extension of the orphan market exclusivity may be available. Although
SPCs are available throughout the EU, holders must apply the patent term extension on a country-by-country basis. Similar patent term
extension rights exist in certain other foreign jurisdictions outside the EU.

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Orphan Drug Designation and Exclusivity

Regulation (EC) No 141/2000 and Regulation (EC)
No. 847/2000 provide that a medicinal product can be designated as an orphan medicinal product by the European Commission, upon satisfactory
scientific assessment by the EMA’s Committee for Orphan Medicinal Products (“COMP”), if the sponsor can establish: (1) that
the product is intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition, where
either (i) such condition affects not more than five in ten thousand persons in the EU when the application is made, or (ii) without
incentives it is unlikely that the marketing of the drug in the EU would generate sufficient return to justify the necessary investment
in its development, and (2) that there exists no satisfactory method of diagnosis, prevention or treatment of the condition in question
that has been authorized in the EU or, if such method exists, the drug will be of significant benefit to those affected by that condition.
In the UK, the MHRA conducts an equivalent assessment, against criteria which have been tailored for the UK population.

The COMP is required to re-assess the granted
orphan designation at the time of marketing authorization grant to ensure that it continues to meet the criteria for the designation to
be maintained. Otherwise, the orphan designation can be revoked. In relation to the UK, the MHRA does not grant orphan designations during
the development of the medicinal product. Instead, the MHRA will decide whether the criteria are satisfied at the point of marketing authorization
grant. An orphan drug designation provides a number of benefits, including fee reductions, fee waivers, protocol assistance (as a type
of scientific advice specific for orphan medicinal products) and the possibility to apply for a centralized EU marketing authorization.
Marketing authorization for an orphan medicinal product benefits from a ten-year period of market exclusivity. During this period of market
exclusivity, the European Commission, national competent authorities of the EU member states may only grant marketing authorization to
a “similar medicinal product” for the same therapeutic indication if: (i) a second applicant can establish that its medicinal
product, although similar to the authorized product, is safer, more effective or otherwise clinically superior; (ii) the marketing
authorization holder for the authorized product consents to a second orphan medicinal product application; or (iii) the marketing
authorization holder for the authorized product cannot supply enough orphan medicinal product. A “similar medicinal product”
is defined as a medicinal product containing a similar active substance or substances as contained in an authorized orphan medicinal product,
and which is intended for the same therapeutic indication. The period of marketing protection for the authorized therapeutic indication
may, however, be reduced to six years if, at the end of the fifth year, it is established that the product no longer meets the criteria
for orphan drug designation because, for example, the product is sufficiently profitable not to justify market exclusivity. Orphan medicinal
product designation does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. Following
the UK’s exit from the EU, the MHRA continues to apply the same orphan market exclusivity framework as the EU.

Periods of Authorization and Renewals

A marketing authorization is valid for five years,
in principle, and it may be renewed indefinitely after five years on the basis of a reevaluation of the risk-benefit balance by the
EMA, the competent authority of the authorizing member state, or the MHRA. To that end, the marketing authorization holder must provide
the EMA, the relevant national competent authority, or the MHRA with a consolidated version of the file in respect of quality, safety
and efficacy, including all variations introduced since the marketing authorization was granted, at least six months before the marketing
authorization expiry date. Once renewed, the marketing authorization is valid for an unlimited period, unless the European Commission,
the relevant national competent authority, or the MHRA decides, on justified grounds relating to pharmacovigilance, to proceed with one
additional five-year renewal period. Any marketing authorization ceases to be valid if it is not followed by the placement of the medicinal
product on the EU market (in the case of the centralized procedure), on the market of the authorizing member state (in the case of a national
procedure), or the UK market (as applicable), within three years after grant of such an authorization.

Regulatory Requirements After Marketing Authorization

Following approval, the holder of the marketing
authorization is required to comply with a range of requirements applicable to the manufacturing, marketing, promotion and sale of the
medicinal product, and must adhere in strict compliance with the applicable EU laws, regulations and guidance. These include compliance
with stringent pharmacovigilance rules, pursuant to which post-authorization studies and additional monitoring obligations can be imposed.
In addition, manufacture and control must also be conducted in strict compliance with cGMP requirements and comparable requirements of
other regulatory bodies in the EU and UK. cGMP requirements apply to the methods, facilities and controls used in manufacturing,
processing and packing of drugs against the quality standards appropriate to the intended use of a medicinal product and as required by
the marketing authorization, clinical trial authorization or product specification.

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Much like the federal healthcare program anti-kickback
law in the United States, the provision of benefits or advantages to physicians to induce or encourage the prescription, recommendation,
endorsement, purchase, supply, order or use of medicinal products is also prohibited in the EU and the UK. The provision of benefits or
advantages to induce or reward improper performance generally is governed by the national anti-bribery laws of EU member states and the
Bribery Act 2010 in the UK. Infringement of these laws could result in substantial fines and imprisonment. Applicable law in Europe further
provides that, where medicinal products are being promoted to persons qualified to prescribe or supply them, no gifts, pecuniary advantages
or benefits in kind may be supplied, offered or promised to such persons unless they are inexpensive and relevant to the practice of medicine
or pharmacy.

Pursuant to national laws, industry codes or professional
codes of conduct payments made to physicians in certain EU member states and the UK must be publicly disclosed. Moreover, agreements with
physicians often must be the subject of prior notification and approval by the physician’s employer, his or her competent professional
organization and/or the regulatory authorities of the individual EU member states, or the UK (as applicable). Failure to comply with these
requirements could result in reputational risk, public reprimands, administrative penalties, fines or imprisonment.

The advertising and promotion of medicinal products
is also subject to laws concerning promotion of medicinal products, interactions with physicians, misleading and comparative advertising
and unfair commercial practices. All advertising and promotional activities for the product must be consistent with the approved summary
of product characteristics, and therefore all off-label promotion is prohibited. Direct-to-consumer advertising of prescription medicines
is also prohibited in the EU and the UK. Although general requirements for advertising and promotion of medicinal products are established
under Directive 2001/83/EC, which was transposed into national law in the UK via the Human Medicines Regulations 2012, the details
are governed by regulations in each European jurisdiction and can differ from one country to another.

Coverage and Reimbursement

Significant uncertainty exists as to the coverage
and reimbursement status of any product candidates for which we may seek regulatory approval by the FDA or other government authorities.
In the United States and markets in other countries, patients generally rely on third-party payors to reimburse all or part of the costs
associated with their treatment. Adequate coverage and reimbursement from governmental healthcare programs, such as Medicare and Medicaid,
and commercial payors is critical to new product acceptance. Our ability to successfully commercialize our product candidates will depend
in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from government
health authorities or programs, private health insurers and other organizations. Even if coverage is provided, the approved reimbursement
amount may not be high enough to allow us to establish or maintain pricing sufficient to realize a sufficient return on our investment.

Government authorities and other third-party payors,
such as private health insurers and health maintenance organizations, decide which medications they will pay for and establish reimbursement
levels. Additionally, coverage and reimbursement for drug products can differ significantly from payor to payor. One third-party payor’s
decision to cover a particular drug product or service does not ensure that other payors will also provide coverage for the drug product,
or will provide coverage at an adequate reimbursement rate. Coverage policies and third-party reimbursement rates may change at any time.
Even if favorable coverage and reimbursement status is attained for one or more product candidates for which we receive regulatory approval
from one or more third party payors, less favorable coverage policies and reimbursement rates may be implemented in the future. Additionally,
if a companion diagnostic test is developed for use with a drug product, any coverage and reimbursement for that test would be separate
and apart from the coverage and reimbursement sought for such product. A lack of coverage or adequate reimbursement for such a test could
adversely affect access to a drug product.

Within the U.S., third-party payors are increasingly
seeking to control drug costs by examining the cost-effectiveness of new products and services in addition to their safety and efficacy;
managing drug utilization and challenging the price of drugs. To obtain or maintain coverage and reimbursement for any future product,
we may need to conduct expensive pharmacoeconomic studies to demonstrate the medical necessity and cost-effectiveness of our product.
These studies will be in addition to the studies required to obtain regulatory approvals. Third-party payors may limit coverage of product
by, for example, only covering specific products on an approved list, or formulary, which might not include all of the FDA-approved products
for a particular indication. Some third-party payors may manage utilization of a particular product by requiring pre-approval (known as
“prior authorization”) for coverage of particular prescriptions (to allow the payor to assess medical necessity) or otherwise
restricting coverage of a product even if used consistent with its approved indication. Manufacturers of marketed drugs may be required
to provide discounts or rebates under government healthcare programs or to certain government and private purchasers in order to obtain
coverage under federal healthcare programs such as Medicaid. More generally, price concessions may need to be offered to third party payors
to obtain favorable coverage or to purchasers to achieve sales. Arrangements with third party payors or purchasers may include value-based
arrangements under which the amount paid for products depends on the performance of the product. Net prices for drugs may be further reduced
by mandatory discounts or rebates required by government healthcare programs or private payors and by any future relaxation of laws that
presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States.

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In addition, in some foreign countries, the proposed
pricing for a drug must be approved before it may be lawfully marketed. The requirements governing drug pricing vary widely from country
to country. For example, the EU provides options for its member states to restrict the range of medicinal products for which their national
health insurance systems provide reimbursement and to control the prices of medicinal products for human use. To obtain reimbursement
or pricing approval, some of these countries may require the completion of clinical trials that compare the cost effectiveness of a particular
medicinal product candidate to currently available therapies. A member state may approve a specific price for the medicinal product or
it may instead adopt a system of direct or indirect controls on the profitability of the company placing the medicinal product on the
market. There can be no assurance that any country that has price controls or reimbursement limitations for pharmaceutical products will
allow favorable reimbursement and pricing arrangements for any of our product candidates. Historically, products launched in the EU do
not follow price structures of the U.S. and generally prices tend to be significantly lower.

Healthcare Reform

Payors, whether domestic or foreign, or governmental
or private, are developing increasingly sophisticated methods of controlling healthcare costs and those methods are not always specifically
adapted for therapies addressing rare diseases such as those we are developing. In both the United States and certain foreign jurisdictions,
there have been a number of legislative and regulatory changes to the healthcare system that could impact our ability to sell our product
candidates profitably if and when approved for marketing. In particular, in 2010, the ACA was enacted, which, among other things, subjected
biologic products to potential competition by lower-cost biosimilars; addressed a new methodology by which rebates owed by manufacturers
under the Medicaid Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected; increased
the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program; extended the Medicaid Drug Rebate program
to utilization of prescriptions of individuals enrolled in Medicaid managed care organizations; subjected manufacturers to new annual
fees and taxes for certain branded prescription drugs; created a new Medicare Part D coverage gap discount program, in which manufacturers
must agree to offer point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage
gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D. More generally, the
ACA expanded healthcare coverage through Medicaid expansion and the implementation of the “individual mandate” for health
insurance coverage.

Beyond the ACA, there have been ongoing healthcare
reform efforts. Drug pricing and payment reform was a focus of the Trump administration and has been a focus of the Biden administration.
For example, federal legislation enacted in 2021 eliminates the statutory cap on Medicaid drug rebate program rebates (currently set at
100% of a drug’s “average manufacturer price”), effective January 1, 2024. As another example, the IRA, includes
a number of changes intended to address rising prescription drug prices in Medicare Parts B and D. These changes include caps on Medicare
Part D out-of-pocket costs, Medicare Part B and Part D drug price inflation rebates, a new Medicare Part D manufacturer
discount drug program (replacing the ACA Medicare Part D coverage gap discount program) and a drug price negotiation program for
certain high spend Medicare Part B and D drugs (with the first list of drugs announced in 2023). The IRA changes have varying implementation
dates that start in 2022. On August 29, 2023, HHS announced the list of the first ten drugs that will be subject to price negotiations.
The focus on healthcare reform, including reform of drug pricing and payment, has continued in the wake of the IRA. For example, in 2022,
subsequent to the enactment of the IRA, the Biden administration released an executive order directing the HHS to report on how the Center
for Medicare and Medicaid Innovation (“CMMI”) could be leveraged to test new models for lowering drug costs for Medicare and
Medicaid beneficiaries. The report was issued in 2023 and proposed various models that CMMI is currently developing which seek to lower
the cost of drugs, promote accessibility and improve quality of care. Further, in December 2023, the Biden administration announced
an initiative to control the price of prescription drugs through the use of march-in rights under the Bayh-Dole Act (which allow the government,
in specified circumstances, to grant or require a patent-holder of technology funded by the federal government to grant a license to certain
third parties). The announcement was followed by publication of Draft Interagency Guidance Framework for Considering the Exercise of March-In
Rights which for the first time includes the price of a product as one factor an agency can use when deciding to exercise march-in rights.
While march-in rights have not previously been exercised, given these actions, there can be no certainty that such rights will not be
exercised in the future.

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Healthcare reform efforts have been and may continue
to be subject to scrutiny and legal challenge. For example, with respect to the ACA, tax reform legislation was enacted that eliminated
the tax penalty established for individuals who do not maintain mandated health insurance coverage beginning in 2019 and, in 2021, the
U.S. Supreme Court dismissed the latest judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality
of the ACA. As another example, revisions to regulations under the federal anti-kickback statute would remove protection for traditional
Medicare Part D discounts offered by pharmaceutical manufacturers to pharmacy benefit managers and health plans. Pursuant to court
order, the removal was delayed and recent legislation imposed a moratorium on implementation of the rule until January 2032. As another
example, the IRA drug price negotiation program has been challenged in litigation filed by various pharmaceutical manufacturers and industry
groups.

There have also been efforts by federal and state
government officials or legislators to implement measures to regulate prices or payment for pharmaceutical products, including legislation
on drug importation. For example, on January 5, 2024, the FDA approved Florida’s Section 804 Importation Program (SIP)
proposal to import certain drugs from Canada for specific state healthcare programs. It is unclear how this program will be implemented,
United States or Canada. Other states have also submitted Section 804 Importation Program (“SIP”) proposals that are
pending review by the FDA. Any such approved importation plans, when implemented, may result in lower drug prices for products covered
by those programs. Recently, there has been considerable public and government scrutiny of pharmaceutical pricing and proposals to address
the perceived high cost of pharmaceuticals. There have also been recent state legislative efforts to address drug costs, which generally
have focused on increasing transparency around drug costs or limiting drug prices.

General legislative cost control measures may
also affect reimbursement for our product candidates. The Budget Control Act, as amended, resulted in the imposition of reductions in
Medicare (but not Medicaid) payments to providers in 2013 that remain in effect through 2032 unless additional Congressional action is
taken. Any significant spending reductions affecting Medicare, Medicaid or other publicly funded or subsidized health programs that may
be implemented and/or any significant taxes or fees that may be imposed on us could have an adverse impact on our results of operations.

Adoption of new legislation at the federal or
state level could affect demand for, or pricing of, any future products if approved for sale. We cannot, however, predict the ultimate
content, timing or effect of any federal and state reform efforts. There is no assurance that federal or state healthcare reform will
not adversely affect our future business and financial results.

Other Healthcare Laws

Pharmaceutical companies are subject to additional
healthcare regulation and enforcement by the federal government and by authorities in the states and foreign jurisdictions in which they
conduct their business that may constrain how we conduct our business, including the financial arrangements and relationships through
which we research, as well as sell, market and distribute any products for which we obtain marketing authorization. Restrictions under
applicable federal and state healthcare laws and regulations, some of which will apply only if and when we receive marketing approval
for a product candidate, include the following:

●
federal healthcare program anti-kickback law, which prohibits, among other things, persons from soliciting, receiving or providing remuneration, directly or indirectly, to induce either the referral of an individual for an item or service or the purchasing or ordering of a good or service, for which payment may be made under federal healthcare programs such as Medicare and Medicaid;

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●
federal false claims, false statements and civil monetary penalties laws which prohibit, among other activities, any person from knowingly presenting, or causing to be presented, a false claim for payment of government funds or knowingly making, or causing to be made, a false statement to get a false claim paid and may be implicated if claims are submitted that result from a violation of the federal anti-kickback statute;

●
HIPAA, which, in addition to privacy protections applicable to healthcare providers and other entities, prohibits executing a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

●
the FDCA, which among other things, strictly regulates drug marketing, prohibits manufacturers from marketing such products for off-label use and regulates the distribution of samples;

●
federal laws that require pharmaceutical manufacturers to report certain calculated product prices to the government or provide certain discounts or rebates to government authorities or private entities, often as a condition of reimbursement under government healthcare programs;

●
the so-called “federal sunshine” law, which requires pharmaceutical and medical device companies to monitor and report certain financial interactions with physicians, certain non-physician practitioners and teaching hospitals to the federal government for re-disclosure to the public;

●
the U.S. Foreign Corrupt Practices Act of 1977, as amended, which prohibits, among other things, U.S. companies and their employees and agents from authorizing, promising, offering, or providing, directly or indirectly, corrupt or improper payments or anything else of value to foreign government officials, employees of public international organizations and foreign government owned or affiliated entities, candidates for foreign political office, and foreign political parties or officials thereof; and

●
analogous state and foreign laws and regulations, such as state anti-bribery, anti-kickback and false claims laws, which may apply to healthcare items or services that are reimbursed by non-governmental third-party payors, including private insurers.

Some state laws require pharmaceutical companies
to comply with specific compliance standards, restrict financial interactions between pharmaceutical companies and healthcare providers
or require pharmaceutical companies to report information related to payments to healthcare providers or marketing expenditures. Other
state laws may require pharmaceutical companies to file reports relating to pricing and marketing information, and state and local laws
may require registration of pharmaceutical sales representatives.

Efforts to ensure that our business arrangements
with third parties comply with applicable healthcare laws and regulations will involve substantial costs. Given the breadth of the laws
and regulations, limited guidance for certain laws and regulations and evolving government interpretations of the laws and regulations,
governmental authorities may possibly conclude that our business practices may not comply with healthcare laws and regulations. If our
operations are found to be in violation of any of the laws described above or any other government regulations that apply to us, we may
be subject to penalties, including significant civil and criminal penalties, damages, fines, exclusion from participation in government
healthcare programs, such as Medicare and Medicaid, imprisonment, and the curtailment or restructuring of our operations, any of which
could adversely affect our business, financial condition, results of operations, and prospects.

Nano-Mupirocin Regulatory Strategy

United States

We may seek FDA approval for Nano-Mupirocin under
the 505(b)(2) regulatory pathway, which is subject to FDA discretion, and there can be no assurance that this pathway will be available
or sufficient for approval. The 505(b)(2) pathway could potentially allow reliance on existing data for an approved active ingredient
while supporting innovation in formulation or route of administration. Mupirocin is currently approved in the U.S. as a topical antibiotic
(Bactroban) but is unsuitable for systemic use due to rapid metabolism and high protein binding.

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Nano-Mupirocin is a novel liposomal formulation
being developed to enable parenteral administration of mupirocin (i.e., administration into the body by routes other than the intestines
or digestive tract), with the goal of evaluating its potential as a systemically active antibiotic. By encapsulating mupirocin in a liposomal
composition similar to that used in the FDA-approved product Doxil (liposomal doxorubicin), preclinical studies suggest that the drug
may be protected in the bloodstream and may exhibit altered bioavailability and antibacterial activity against serious and resistant bacterial
pathogens identified by the CDC. However, these observations are limited to preclinical models, and there can be no assurance that such
effects will be observed in humans, that they will result in clinical benefit, or that they will be sufficient for regulatory approval.

While no assurance can be provided, we believe
that the 505(b)(2) pathway may provide an appropriate regulatory approach for this product, subject to FDA discretion, as it could allow
us to bridge existing data on both the active ingredient (mupirocin) and the well-characterized and FDA-approved liposomal delivery platform,
while generating new data specific to the systemic application of the formulation. This regulatory strategy may provide a scientifically
sound and capital-efficient path to approval and could potentially facilitate development of a critical new therapeutic in the context
of the growing global threat of antimicrobial resistance.

We believe that the 505(b)(2) pathway may be appropriate,
subject to FDA discretion, as it could allow the sponsor to reference existing safety and efficacy data on mupirocin from prior approvals
and published literature, while requiring new data to bridge the change in formulation, route of administration, and indication. The 505(b)(2)
application may rely in part on existing data for the known active ingredient, mupirocin, from the Reference Listed Drug (Bactroban, GSK).
If accepted by the FDA, this approach may enable us to leverage available data on mupirocin, including toxicological and efficacy data
from studies previously conducted by other sponsors. If permitted, this pathway could potentially offer a more efficient and capital-sparing
route to approval compared to traditional development pathways, such as 505(b)(1). While this approach may help reduce duplicative studies,
shorten timelines, and lower cost, there can be no assurance that the FDA will accept this strategy or that it will ultimately result
in approval.”

This approach has been used in other cases involving
repurposed or reformulated drugs like Liposomal Mupirocin and we believe it could be applicable for nanoparticle, liposomal, or IV versions
of previously approved compounds.

Given the public health priority of antibiotic
resistance, we may seek QIDP designation (Qualified Infectious Disease Product) and Fast Track status, which provide priority review and
extended exclusivity.

We plan to seek regulatory support mechanisms,
including Orphan Drug Designation (ODD), which may provide market exclusivity, FDA fee waivers, and potential tax credits.

Additional designations which we may pursue include:

I. Qualified Infectious Disease Product (QIDP):
Grants an extra 5 years of exclusivity.

●
Fast Track Designation: Allows for early and frequent FDA engagement.

●
Breakthrough Therapy Designation: Contingent on significant clinical benefit signals during early trials.

AMR-Orphan Indication program is structured to
target diseases with low prevalence in the United States, qualifying for Orphan Drug Designation (ODD). In our assessment, we identified
several antimicrobial-resistant (AMR) indications listed in the FDA’s orphan designation database that are suitable for development
based on the known spectrum of activity of mupirocin. These include infections where MRSA, VRE, and other resistant Gram-positive pathogens
are involved, and where liposomal delivery offers added benefit.

Focusing on these AMR-related orphan indications
supports a targeted clinical development plan with high unmet medical need, potentially more focused clinical trial designs, and a strong
alignment with public health priorities. This also enhances the potential to access key regulatory incentives and pathways dedicated to
antimicrobial resistance. The Company is evaluating potential regulatory pathways that may include eligibility for Qualified Infectious
Disease Product (QIDP) designation and Fast Track designation. If granted, such designations may provide certain regulatory benefits,
including the potential for priority review and extended market exclusivity; however, there can be no assurance that the Company will
obtain any such designations.

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The Company may be eligible to receive a Priority Review Voucher (PRV)
from the U.S. FDA, if approved, for certain qualifying indications, including those that meet the criteria of the FDA’s rare pediatric
disease, , or other applicable PRV programs. Eligibility is subject to meeting applicable statutory and regulatory requirements, and there
can be no assurance that any of the Company’s product candidates will qualify.

A PRV entitles the holder to an expedited priority review of approximately
six months for a subsequent marketing application, compared to the standard ten-month review cycle. While PRVs are transferable and may
be sold to third parties, there can be no assurance that the Company will be granted a PRV, successfully transfer such a voucher, or realize
any material economic benefit from its issuance.

Expedited Regulatory Pathways and Potential
Designations

We intend to evaluate and, where appropriate,
pursue various expedited development and review pathways provided by the U.S. Food and Drug Administration (FDA), including Orphan Drug
Designation (ODD), Breakthrough Therapy designation (BTD), Fast Track designation, and Priority Review, for certain of our product candidates
such as Nano-Mupirocin, Nano-Candesartan (as an ARB cancer therapy adjuvant), and our liposomal vaccine platform. These regulatory programs
are intended to facilitate the development and expedite the review of drugs that treat serious conditions and address unmet medical needs.

Basis for Potential Eligibility:

Based on early-stage preclinical data and the
indications we are targeting, we believe that certain of our product candidates may meet the preliminary criteria for expedited development
programs. For example:

●
Nano-Mupirocin may be eligible for Fast Track designation or QIDP status due to its potential to address serious, multidrug-resistant Gram-positive infections, including MRSA.

●
Nano-Candesartan may qualify for Breakthrough Therapy designation if future clinical data demonstrate substantial improvement over available therapies in oncology settings. See Description of Business, Our Second Lead Candidate, Nano-Candesartan (nanoparticles-based ARB), is targeted for combination therapy with an initial indication in pancreatic ductal adenocarcinoma (PDAC).

However, these beliefs are based on our current
development plans and nonclinical data, and actual eligibility for any FDA designation is subject to further evaluation by the FDA following
submission of the relevant data.

Limitations and Regulatory Uncertainty:

While these designations can provide potential
benefits, including more frequent interactions with the FDA, eligibility for rolling submissions, and in some cases shorter review timelines,
they do not guarantee a faster development or approval process. Moreover, they do not increase the likelihood that a product candidate
will ultimately receive marketing approval. Because our product candidates are in early stages of development, there can be no assurance
that the FDA will grant any such designation or accept any application under an expedited program.

Furthermore, even if one or more of our product
candidates receive such designations, the FDA may later rescind them if subsequent data fail to confirm the initial qualifying criteria.

European Union

We intend to pursue marketing authorization for
Nano-Mupirocin via the European Medicines Agency (EMA) under the centralized procedure, which ensures access across all EU member states
and is required for novel antimicrobial therapies. Nano-Mupirocin, a novel liposomal formulation of mupirocin for systemic (parenteral)
use, is designed to treat serious, resistant bacterial infections, addressing critical unmet needs in the context of antimicrobial resistance
(AMR). However, this program remains at a preclinical stage, and there can be no assurance that Nano-Mupirocin will demonstrate safety
or efficacy in humans, or that it will receive regulatory approval in the EU or elsewhere.

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Given the severity and limited treatment options
for certain resistant infections, particularly those affecting vulnerable populations, we plan to seek Orphan Medicinal Product Designation
(OMPD) for relevant rare infectious disease indications. To qualify, we will demonstrate that:

●
The target condition has a prevalence of fewer than 5 in 10,000 individuals in the EU;

●
Nano-Mupirocin offers significant benefit over existing therapies, such as improved systemic activity or a novel mechanism of action;

●
There is a plausible scientific rationale for its clinical effect in the proposed indication.

●
Upon OMPD approval, the product will benefit from:

●
10 years of market exclusivity in the orphan indication;

●
Protocol assistance (free or reduced-cost scientific advice);

●
Fee reductions for various regulatory activities.

As part of our development strategy, we also intend
to submit a Pediatric Investigation Plan (PIP), as required under EU regulation for all new marketing authorization applications, including
orphan drugs. Given the increasing incidence of multidrug-resistant infections in pediatric populations, especially in neonatal and pediatric
intensive care settings, Nano-Mupirocin may offer an important pediatric therapeutic alternative. We plan to engage early with EMA’s
Pediatric Committee (PDCO) to define an age-appropriate development plan or, where justified, request a waiver or deferral based on disease
prevalence and clinical feasibility.

Depending on the strength of clinical data and the magnitude of unmet
need, we may also pursue:

●
Accelerated Assessment, reducing EMA review timelines from 210 to 150 days;

●
Conditional Marketing Authorization, particularly if robust efficacy and safety data can be demonstrated in Phase 2 studies and the product is addressing a life-threatening or seriously debilitating condition;

●
Future inclusion under Europe’s AMR-focused regulatory and incentive frameworks, currently under revision.

China

We intend to pursue regulatory approval for Nano-Mupirocin
in China through the National Medical Products Administration (NMPA) under the classification of a Class 1 New Chemical Drug, due to its
novel liposomal formulation enabling systemic (parenteral) use of mupirocin, which is currently approved in China only as a topical agent.

Given the escalating burden of antimicrobial resistance
in China and the urgent need for systemically active antibiotics targeting multidrug-resistant pathogens, Nano-Mupirocin may qualify for
Breakthrough Therapy designation or Priority Review, especially if supported by compelling Phase 2/3 data. We will also evaluate eligibility
for inclusion in China’s Urgently Needed Imported Drug List, which can provide a fast-track review pathway if initial clinical trials
are conducted overseas and meet China’s public health priorities.

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The development pathway may include:

●
Pre-IND consultation with CDE to align on the need for bridging studies, acceptance of overseas data, and specific technical requirements for liposomal formulations.

●
Submission of a clinical trial application (CTA) in China, which must be approved before initiating local clinical trials unless exemptions apply.

●
A possible requirement for local Phase 1 or bridging PK studies, depending on the origin and scope of the global clinical package.

●
Full New Drug Application (NDA) submission following successful completion of clinical development, CMC review, and local site inspections.

●
To support regulatory success, we will ensure early alignment on CMC requirements specific to liposomal products, including characterization, release specifications, and stability, in accordance with ICH and Chinese Pharmacopoeia standards.

Japan

In Japan, we intend to file through the Pharmaceuticals
and Medical Devices Agency (PMDA) and anticipate applying under the Sakigake designation. This program offers expedited review for innovative
therapies and is broadly comparable to the FDA’s Fast Track designation in the United States.

Novel ARB Combination Therapy Regulatory Strategy

United States

We may seek FDA approval for Nano-Candesartan
under the 505(b)(2) pathway, which is subject to FDA discretion, and there can be no assurance that this pathway will be available or
sufficient for approval. This approach could potentially allow us to reference existing safety and pharmacology data from the reference
product, Candesartan, as well as the regulatory precedent for the liposomal delivery platform used in FDA-approved products such as Doxil.
Nano-Candesartan is a PEGylated liposomal formulation of candesartan, a widely used angiotensin II receptor blocker (ARB) currently approved
for hypertension and heart failure (e.g., Atacand). Our novel formulation introduces a new route of administration and a potential therapeutic
use in oncology, while relying on components with demonstrated safety and prior regulatory acceptance. While this pathway may provide
a more efficient development route compared to traditional approaches, there can be no assurance that the FDA will approve it.

While the cardiovascular indications of candesartan
are well established, emerging evidence has demonstrated its potential in oncology, particularly through modulation of the tumor microenvironment
(TME). Candesartan has been shown to reduce tumor-associated fibrosis, lower interstitial pressure, and normalize abnormal tumor vasculature—mechanisms
that enhance the intratumoral delivery and efficacy of co-administered therapies such as chemotherapy and immune checkpoint inhibitors.

Encapsulation of candesartan in nano-liposomes
enables targeted delivery to tumor tissue, prolongs circulation time, and significantly reduces systemic exposure and side effects, such
as hypotension. This targeted approach enhances the drug’s therapeutic index and supports its repurposing for oncology indications,
including hard-to-treat cancers like pancreatic adenocarcinoma.

We believe that the 505(b)(2) pathway may be scientifically
and strategically appropriate for this product, subject to FDA discretion. This pathway could potentially permit reliance on established
safety and pharmacology data from the reference listed drug (Atacand), while requiring us to generate new data specific to the novel liposomal
formulation and its intended oncology use. This approach may help streamline development timelines, may reduce costs, and could potentially
accelerate market entry compared to the 505(b)(1) pathway. However, the FDA must agree with our assessment, and there can be no assurance
that the 505(b)(2) pathway will be accepted or sufficient for approval.

For our oncology combination therapy program,
we may decide to prioritize regulatory filings in the United States and Europe, with a phased expansion into Asia based on emerging data
and partnership opportunities.

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Given the increasing incidence of therapy-resistant
cancers and the need for new treatment strategies, Nano-Candesartan is being evaluated as a potential therapy. We may prioritize regulatory
discussions in the United States and Europe and may seek Orphan Drug Designation for oncology indications such as pancreatic cancer. Any
such designation is subject to regulatory discretion, and there can be no assurance that it will be granted or that it will provide the
anticipated benefits. See Description of Business, Our Second Lead Candidate, Nano-Candesartan (nanoparticles-based ARB), is targeted
for combination therapy with an initial indication in pancreatic ductal adenocarcinoma (PDAC) for a discussion of a disagreement between
us and Yissum as to our rights to the nano-cadesartan license.

Europe

We intend to seek regulatory approval for Liposomal-ARB
through the European Medicines Agency (EMA) via the centralized marketing authorization procedure, which is mandatory for all medicinal
products designated as Orphan Medicinal Products and ensures simultaneous access across all EU member states.

Given the poor prognosis and limited treatment
options associated with advanced pancreatic cancer, we may seek Orphan Medicinal Product Designation (OMPD) for Liposomal-ARB under Regulation
(EC) No 141/2000. To qualify, we may provide:

●
Justification that pancreatic cancer affects fewer than 5 in 10,000 individuals in the EU.

●
Evidence of the product’s potential significant benefit over existing treatments, such as FOLFIRINOX or gemcitabine/nab-paclitaxel, particularly when used in combination regimens.

●
Data supporting the drug’s unique mechanism of action, involving tumor microenvironment normalization and improved drug penetration.

●
Upon designation, we will benefit from a range of regulatory incentives, including:

●
10 years of market exclusivity in the orphan indication

●
Protocol assistance from the EMA, including scientific advice specifically tailored for orphan development

●
Fee reductions for regulatory procedures (e.g., scientific advice, inspections, and marketing authorization)

If interim or early clinical data demonstrate
compelling activity or address a critical unmet need, we will also evaluate eligibility for:

●
Conditional Marketing Authorization, allowing approval based on less comprehensive data if the benefit-risk balance is positive and further data will be provided post-approval.

●
Accelerated Assessment, which shortens the EMA review period from 210 to 150 days.

We may engage with the Committee for Orphan Medicinal
Products (COMP) during development to discuss potential designation, and we may also seek scientific advice regarding pivotal trial design,
comparator selection, and endpoints. The content, timing, and outcome of such interactions remain subject to regulatory discretion, and
there can be no assurance of acceptance.

China

We may seek regulatory approval for our novel
formulation of Liposomal-ARB in China through the National Medical Products Administration (NMPA) as a Class 1 New Drug, based on its
novel liposomal formulation and intended use in oncology. While candesartan is an approved antihypertensive agent in China, our liposomal
formulation represents a new route of administration (intravenous) and a distinct therapeutic indication (cancer treatment), qualifying
it as a new drug under NMPA’s classification system.

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Given the novel mechanism of action in oncology,
through tumor microenvironment (TME) modulation, and its potential synergy with chemotherapy and immunotherapy, Liposomal-ARB may be eligible
for the following expedited programs:

●
Breakthrough Therapy Designation (BTD), if early clinical data in China or abroad demonstrate significant clinical advantages over existing treatments.

●
Priority Review which regulators may consider in cases of significant unmet medical need in solid tumors such as pancreatic or liver cancer.

●
China’s Urgently Needed Overseas Drugs Pathway, which may be considered if supported by compelling clinical data and recognition in major regulatory jurisdictions (e.g., FDA or EMA)..

Development Pathway:

●
Pre-IND Consultation with CDE: We plan to initiate communication with the Center for Drug Evaluation (CDE) to confirm clinical development expectations, including the acceptability of foreign clinical data, bridging study requirements, and technical data for the liposomal formulation.

●
Clinical Trial Application (CTA): A CTA will be submitted to initiate clinical studies in China, with the potential for waiver or abbreviated trials if global data are robust and a local bridging study is sufficient.

●
Local PK/bridging studies: May be required to support ethnic sensitivity and dose justification.

●
New Drug Application (NDA) submission upon completion of pivotal data and CMC review. The NDA will include full data on safety, efficacy, manufacturing, and quality, and must comply with both ICH and Chinese Pharmacopoeia standards.

Given the increasing regulatory alignment between
NMPA and global standards, including China’s implementation of ICH E6 (R2) and E17 for multi-regional clinical trials (MRCTs), we
are designing our development program to enable seamless inclusion of Chinese sites in global pivotal trials.

Japan: we plan to engage with the Pharmaceuticals
and Medical Devices Agency (PMDA) to pursue regulatory approval under Japan’s standard NDA pathway. Given the innovation and potential
life-extending benefit of Liposomal-ARB in pancreatic cancer, we may seek qualification for the Sakigake designation, which supports expedited
development and review of promising therapies addressing high unmet needs in Japan.

Employees

We currently have three
(3) full-time employees, three (3) part time employee, and 10 experienced consultants, including two (2) on administrative level, five
(5) in the scientific and product development and three (3) in the medical (clinical trials) field. Our employees work at will and are
not represented by a collective bargaining unit. We believe our relationship with our employees is excellent in most cases. We require
all our employees and consultants to sign a confidentiality and non-disclosure agreement. Our success relies on our ability to hire additional
employees, particularly on the local sales side. We believe there are numerous quality people to choose from throughout our area of targeted
expansion.

Subsidiaries

The Company has two wholly-owned subsidiary, Revium
Rx, Ltd. and LipoVation Ltd., each organized under the laws of the State of Israel.

Corporate Office

Our principal executive office is at Azrieli Business
Center, 89 Medinat HaYehudim Herzliya, Israel. Our main telephone number is 1 800 519-1687.

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Legal Proceedings

There are no pending
legal proceedings to which the Company is a party or in which any director, officer or affiliate of the Company, any owner of record or
beneficially of more than 5% of any class of voting securities of the Company, or security holder is a party adverse to the Company or
has a material interest adverse to the Company. The Company’s property is not the subject of any pending legal proceedings.