NYSE: OGEN

We
believe the proprietary powder formulation and intranasal administration allows for rapid and direct accessibility to the brain. The
device is breath propelled and is designed to allow patients to blow into the device which closes the soft palate in the back of the
nasopharynx, preventing the flow of drug to the lungs or esophagus, minimizes system exposure and side effects, and effectively crosses
the blood brain barrier. This mechanism is designed to trap ONP-002 in the nasal cavity allowing for more abundant and faster drug availability
in the traumatized brain.

Expected
ONP-002 Product Development Timeline:

Pre-clinical
Animal Studies

Phase
1 clinical trial

Phase
2a clinical trial

US
based clinical trial

Phase
3 clinical trial

Complete

Complete

Q1
2026 Start

Estimated
Q1 2027 start

Estimated
Q1 2028 start

This
product development plan is an estimate and is subject to change based on funding, technical risks and regulatory approvals.

Validation
and Stability of ONP-002

A
Certificate of Analysis (COA) was issued by the manufacturer of the drug, indicating that testing methods were standard and include appearance,
identification by 1H NMR (a technique used to determine the structure of organic molecules), identification by Mass Spectroscopy (MS),
optical purity by HPLC, residual solvent analysis, elemental impurities, percent water, and residue on ignition. The manufacturer has
shown both the specifications and the results, indicating that the material supplied passes all criteria. ONP-002 is supplied in pure
form. As such, no excipients are present. Stability studies were performed by storing samples under carefully controlled conditions with
respect to temperature and humidity. The stability testing protocol included storage at 25 °C± 2 °C at 60% relative humidity
± 5% relative humidity for 24 months and 40 °C± 2 °C at 75% relative humidity ± 5% for 18 months. Samples
were pulled at the scheduled time and analyzed for appearance, purity, assay, optical purity, and water content. No changes in ONP-002
were seen.

Intellectual
Property

Patent
applications that concern ONP-002 and the nasal delivery device have been filed as follows:

● New
chemical entity patent filings concerning the C-20 steroid compounds have been filed with
the USPTO and are pending in the U.S. To date, national patents in 9 different countries
have been granted, including European countries and Canada and Philippines. A bundle of
patents under the European Patent Convention have also been granted, namely, France, Germany,
Ireland, Italy, Spain, Switzerland and UK.

○ C-20
steroid compounds, composition and uses thereof to treat traumatic brain injury (TBI), including
concussion.

○ Inventions relate to, inter alia, ONP-002 compositions,
methods of use to treat and/or, minimize traumatic brain injury (TBI), including severe TBI, moderate TBI, and mild TBI, including
concussions, methods of manufacture and/or synthesis, products by process, and intermediates.

○ An
issued U.S. patent expiration with 5-year maximum patent term extension - 9/17/2040.

○ An
issued U.S. patent expiration without patent term extension - 9/17/2035.

● Multiple
nasal delivery device patent applications concerning the Breath-Powered Nasal Devices and
Uses Thereof have been filed in the U.S. with the USPTO as utility patent applications.
In addition, multiple nationalized patent applications drawn to the Breath-Powered Nasal
Devices and Uses Thereof have been filed in over 60 countries.

○ Breath-Powered
Nasal Devices and Uses Thereof for, inter alia, treatment of TBI, Including Concussion,
and Methods.

○ Inventions
relate to, inter alia, breath-powered nasal devices, single-directional breath-powered nasal
devices for providing dual airflow for propelling a drug substance into a nasal cavity for
targeted delivery to the olfactory region in high drug substance concentration for rapid
diffusion into the brain for the treatment of local or systemic and/or central nervous system
(“CNS”) injury, disease or disorder, and methods of treating local or systemic
and/or CNS injury, disease or disorder with such devices.

○ An
exemplary issued U.S. patent expiration - 10/19/2042.

1

ONP-002
Development and Studies

ONP-002
Pre-Clinical Trials

The
ONP-002 drug has completed toxicology studies in rats and dogs. Those studies show that ONP-002 has a large safety margin for its predicted
efficacious dose. In preclinical animal studies, the drug demonstrated rapid and broad biodistribution throughout the brain while simultaneously
reducing swelling, inflammation, and oxidative stress, along with an excellent safety profile.

Results
from the preclinical studies suggest that ONP-002 has an equivalent, and potentially superior, neuroprotective effect compared to related
neurosteroids. The animals treated with the drug post-concussion showed positive behavioral outcomes using various testing platforms
including improved memory and sensory-motor performance, and reduced depression and anxiety-like behaviors.

ONP-002
Induction of Pregnane X Receptor (PXR)

The
induction of the human CYP450 enzymes, CYP2B6, and CYP3A4, by ONP-002, as measured by mRNA expression, was tested in human hepatocytes
from 3 donors at 3 concentrations: 1 μM, 10 μM and 100 μM. Results reflected that ONP-002, through the known PXR-mechanism,
produced a modest induction of CYP3A4, up to 17% of the positive control, and a greater induction of CYP2B6, of up to 59% of the positive
control, both at a concentration of 100 μM. Past data reflected that ONP-001 (entProgesterone) and Progesterone induce the PXR receptor.
Receptor binding studies have been performed showing ONP-002 does not activate the classical Progesterone Receptor.

ONP-002
Animal Studies

All
surgical animals (male Sprague-Dawley rats weighing approximately 250 grams) were anesthetized with an initial isoflurane induction for
4 minutes, the minimum time necessary to sedate the animal. The scalp was shaved and cleaned with isopropanol and betadine. During the
stereotaxic surgery, anesthesia was maintained with isoflurane. A medial incision was made, and the scalp was pulled back over the medial
frontal cortex. A 6mm diameter craniotomy was performed exposing the brain tissue. An electrically controlled injury device using a 5mm
metal impactor was positioned over the exposed brain. An impact speed of 1.6 m/s at a 90-degree angle from vertical was used to produce
an open head injury at a depth of 1mm to create a milder TBI. All treatments were given intranasal (IN) as a liquid solution with a micro
atomizer. Vehicle for all administrations was 22.5% Hydroxy-Propyl-β-cyclodextrin (HPβCD).

Molecular
Studies - Brain tissue was taken from the penumbral region of injury.

Cerebral
Edema

In
Figure 1, we show that ONP-002 reduces swelling in rats compared to vehicle-treated at 24hours after brain injury by measure of brain
water content through speed-vacuum dehydration and tissue weight comparisons. ONP-002-treated (4mg/kg) and vehicle-treated were compared
to sham which was set at zero. Local edema can occur after mTBI.

Severe
cerebral edema is associated with poor outcomes including increased mortality after mTBI with Second Impact Syndrome (2). *Denotes
significance at p<0.05, n=6

Figure
1

Inflammation

mTBI
causes vascular and neuronal stress. Microglia and reactive astrocytes infiltrate the areas of injury and release inflammatory mediators
like TNF-alpha. We show that ONP-002 (4mg/kg) reduces TNF-alpha-mediated neuroinflammation in brain tissue of rats compared to vehicle
at 24 hours after mTBI (ELISA).

2

Pharmacokinetics
and Safety of IN ONP-002 in Dogs

This
pivotal GLP 14-day study used repeat dosing of ONP-002, 3X a day, approximately 4 hours apart, for 14 consecutive days at concentrations
of 0, 3, 10 or 23 mg/mL at a volume of 1ml/nostril to beagle dogs (both nostrils had drug administered). The IN treatment was given as
a liquid solution using a micro atomizer using 22.5% HPβCD as the vehicle. IN ONP-002 dosing revealed that ONP-002 was well tolerated
up to the highest dose of 23mg/ml or 46mg in total per dosing. Clinical observations were limited to increased salivation in dogs which
occurred in a dose-dependent manner. There were no effects on body weight, food consumption, ophthalmic parameters, clinical chemistry,
hematology, or organ weights at any of the doses tested. Microscopic analysis revealed purulent exudates in the nasal turbinate and evidence
of inflammatory infiltrates and fibrin deposition in the lungs. All of these events were classified as mild, reversed during the recovery
period, and did not appear to show any dose dependency. Similar findings were evident in vehicle control treated dogs indicating the
findings were vehicle related. The highest dose of 23mg/ml was thus determined to be the no-observed adverse-effect level (NOAEL), which
is equivalent to a ONP-002 dose of 1.5mg/kg and 2.3mg/kg in male and female dogs, respectively. Testing shows the dose-dependent increase
in plasma exposure of ONP-002 in male and female dogs following IN administration. Plasma exposure levels were similar in males and females
and there did not appear to be any evidence of drug accumulation following multiple doses.

Cardiopulmonary
Safety Pharmacology

The
effect of ONP-002 on the human ether-a-go-go related gene (hERG) tail currents was assessed in a non-Good Laboratory Practice (GLP) study
using manual whole-cell patch clamp. ONP-002 tested at a single concentration of 10μM inhibited hERG tail currents by 42.6% (n=3).
In order to achieve a safety factor of 30-fold between in vitro hERG IC50 and free plasma levels of ONP-002 in clinical studies, Cmax
should not exceed a free drug concentration of 0.33μM (99ng/ml). ONP-002 is 97.2% human plasma protein bound and is estimated to reach
a plasma Cmax of 12.5nM, the highest dose of 0.533mg/kg to be administered in the planned first in human (FIH) study, which provides
a safety factor of 800-fold. A GLP study is planned at Charles River, Inc. and will be performed prior to IND submission.

ONP-002
Clinical Trials

ONP-002
has completed a Phase 1 clinical trial in healthy human subjects showing it is safe and well tolerated.

Safety
studies have established a dosing regimen of 2X/day for fourteen days. The Phase I clinical trial was performed in Melbourne, Australia
with a Contract Research Organization (CRO), Avance Clinical Pty Ltd and Nucleus Network Pty Ltd. The country of Australia provides a
currency exchange advantage and a tax rebate at the end of our fiscal year from the Australian government on all Research and Development
performed in Australia.

The
Phase 1 study was double-blinded, randomized and placebo controlled (3:1, drug: placebo). Phase 1 used a Single Ascending/Multiple Ascending
(SAD/MAD) drug administration design. The SAD component was a 1X treatment (low, medium, or high dose) and the MAD component was a 1X/day
treatment for five consecutive days (low and medium dose). Blood and urine samples were collected at multiple time points for safety
pharmacokinetics. Standard safety monitoring was provided for each body system.

Forty
human subjects (31 males, 9 females) were successfully enrolled in Phase I. The Safety Review Board, made up of medical doctors, has
reviewed the trial data and has determined the drug is safe and well tolerated at all dosing levels.

After
a delay due to a large hospital merger in Australia that included our lead site, we anticipate launching our Phase 2a clinical trials
in Australia in the first quarter of 2026. Phase 2a clinical trials are focused on feasibility metrics and we anticipate that this data
will be important in our clinical trial design and strategy for future U.S. based clinical trials.

We
anticipate preparing for Phase 2b clinical trials to further evaluate ONP-002’s safety and efficacy. Based on the Phase I data,
we plan to apply for an Investigational New Drug application (IND) with the FDA and conduct a Phase 2b trial in the U.S. Additional non-clinical
studies are planned for 2026 as part of our IND submission strategy.

Business
Development Strategy

Success
in the biopharmaceutical and product development industry relies on the continuous development of novel product candidates. Most product
candidates do not make it past the clinical development stage, which forces companies to look externally for innovation. Accordingly,
we expect, from time to time, to seek strategic opportunities through various forms of business development, which can include strategic
alliances, licensing deals, joint ventures, collaborations, equity or debt-based investments, dispositions, mergers, and acquisitions.
We view these business development activities as a necessary component of our strategies, and we seek to enhance shareholder value by
evaluating business development opportunities both within and complementary to our current business, as well as opportunities that may
be new and separate from the development of our existing product candidates.

Market
Opportunity

We
are currently focused on applying intranasal drug delivery to the development of therapies for neurological conditions, including mild
traumatic brain injury (“mTBI” or concussion). We believe the treatment of concussion represents a significant unmet medical
need, as there are currently no FDA-approved pharmacological therapies specifically indicated for the treatment of concussion.

We
believe intranasal delivery may offer certain advantages compared to systemic administration, including non-invasive administration and
the potential for more rapid central nervous system exposure. Systemic administration can present challenges in achieving efficient delivery
of certain therapies to the central nervous system, which we believe present an opportunity for intranasal drug delivery approaches.

Growth
Strategy

If
the FDA clears or approves our product candidates to be marketed commercially, we intend to enter into agreements with industry partners
or qualified distributors throughout the U.S. We intend to pursue a similar approach if our product candidates are cleared or approved
for marketing outside of the U.S. We intend to require such partners or distributors to pay us an initial license fee, as well as royalties
based on gross sales. Retaining exclusivity is expected to be based on a mutually agreeable semi-annual or quarterly sales minimum. We
also anticipate focusing on international growth because, generally, we believe such international license agreements provide a stronger
path to revenue and earnings than purely domestic products.

Our
objective is to eventually grow revenue through marketing and sales of ONP-002 if it gains regulatory approvals. Although no assurances
can be given, management anticipates company growth from the following areas:

1) Distribution
or License Agreements. Once any of our products in development are approved by the appropriate
regulatory agency, we plan to enter into distribution agreements with companies that have
sales professionals with experience selling through a variety of sales methods. These distribution
agreements should allow us to achieve sales and revenue more quickly in the medical products
industries.

2) Identify
and develop our products for additional proprietary uses. When funding allows, we intend
to utilize our proprietary nasal delivery system to deliver other drugs to the brain to treat
brain-related medical issues.

3) The
development and acquisition of new products. We intend to pursue the development and
acquisition of other product candidates and market any new products, if cleared or approved.
We intend, as capital resources permit, to develop such opportunities if and when they present
themselves.

4) Seek
partners to assist in the further development of our drug device combination products.
We intend to seek partners to assist with the further development and clinical trials of
ONP-002. Partnerships could be in the form of government grants or from industry pharmaceutical
companies who have an interest in brain-related drug therapies.

We
currently have no products authorized for commercial distribution in the U.S., Europe, or any other country. We have development programs
for devices and pharmaceutical drugs, which are in various stages of development. Currently we are only funding the development of ONP-002
which is intended to treat concussion. All of our products require regulatory clearance or approvals, and we cannot begin marketing and
selling our product candidates until we obtain applicable authorizations from the respective regulatory agency.

3

Government
Regulations

In
the U.S., foods (including dietary supplements), drugs (including biological products), medical devices, cosmetics, tobacco products
and radiation-emitting products are subject to extensive regulation by the FDA. The FDC Act and other federal and state statutes and
regulations govern, among other things, the manufacture, distribution and sale of these products. These laws and regulations prescribe
criminal and civil penalties that can be assessed, and violation of these laws and regulations can result in enforcement actions by the
FDA and other regulatory agencies.

FDA
Regulation of Drugs - New Drug Approval Process

Pharmaceutical
products are subject to extensive regulation by the FDA. The FDC Act, and other federal and state statutes and regulations, govern, among
other things, the research, development, testing, manufacture, storage, recordkeeping, approval, labeling, promotion and marketing, distribution,
post-approval monitoring and reporting, sampling, and import and export of pharmaceutical products. Failure to comply with applicable
U.S. requirements may subject a company to a variety of administrative or judicial sanctions, such as FDA refusal to approve pending
NDAs or Biologics License Applications (BLAs), warning or untitled letters, product recalls, product seizures, total or partial suspension
of production or distribution, injunctions, fines, civil penalties and criminal prosecution.

Pharmaceutical
product development for a new product or certain changes to an approved product in the U.S. typically involves the following steps before
a biological product or new drug may be marketed in the U.S.:

● pre-clinical
laboratory tests, animal studies and formulation studies in compliance with the FDA’s
Good Laboratory Practice and Good Manufacturing Practice regulations;

● submission
to the FDA of an IND application for human clinical testing, which must become effective
before human clinical trials may commence;

● performance
of adequate and well-controlled clinical trials in three phases, as described below, to establish
the safety and efficacy of the drug for each indication according to Good Clinical Practices;

● submission
of an NDA or BLA to the FDA for review;

● random
inspections of clinical sites to ensure validity of clinical safety and efficacy data;

● satisfactory
completion of an FDA inspection of the manufacturing facility or facilities at which the
drug is produced to assess compliance with current good manufacturing practices;

● FDA
approval of the NDA or BLA; and

● payment
of user and establishment fees, if applicable.

Satisfaction
of FDA pre-market approval requirements typically takes many years, and the actual time required may vary substantially based upon the
type, complexity and novelty of the product or disease.

Pre-clinical
tests include laboratory evaluation of product chemistry, formulation and toxicity, as well as animal trials to assess the characteristics
and potential safety and efficacy of the product. The conduct of the pre-clinical tests must comply with federal regulations and requirements,
including good laboratory practices. The results of preclinical testing are submitted to the FDA as part of an IND along with other information,
including information about product chemistry, manufacturing and controls, and a proposed clinical trial protocol. Long term pre-clinical
tests, such as animal tests of reproductive toxicity and carcinogenicity, may continue after the IND is submitted.

A
30-day waiting period after the submission of each IND is required prior to the commencement of clinical testing in humans. If the FDA
has neither commented on nor questioned the IND within this 30-day period, the clinical trial proposed in the IND may begin.

Clinical
trials involve the administration of the IND to healthy volunteers or patients under the supervision of a qualified investigator. Clinical
trials must be conducted: (i) in compliance with federal regulations; (ii) in compliance with good clinical practice, or GCP, an international
standard meant to protect the rights and health of patients and to define the roles of clinical trial sponsors, administrators, and monitors;
as well as (iii) under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety, and the effectiveness
criteria to be evaluated. Each protocol involving testing on U.S. patients and subsequent protocol amendments must be submitted to the
FDA as part of the IND.

4

The
FDA may order the temporary, or permanent, discontinuation of a clinical trial at any time, or impose other sanctions, if it believes
that the clinical trial is not being conducted in accordance with FDA requirements or presents an unacceptable risk to the clinical trial
patients. The trial protocol and informed consent information for patients in clinical trials must also be submitted to an institutional
review board or IRB for approval. An IRB may also require the clinical trial at the site to be halted, either temporarily or permanently,
for failure to comply with the IRB’s requirements, or may impose other conditions.

Clinical
trials to support NDAs or BLAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap.
In Phase 1, after the initial introduction of the drug into healthy human subjects or patients, the drug is tested to assess metabolism,
pharmacokinetics, pharmacological actions, side effects associated with increasing doses, and, if possible, early evidence on effectiveness.
Phase 2 usually involves trials in a limited patient population to determine the effectiveness of the drug for a particular indication,
dosage tolerance, and optimum dosage, and to identify common adverse effects and safety risks. If a compound demonstrates evidence of
effectiveness and an acceptable safety profile in Phase 2 evaluations, Phase 3 trials are undertaken to obtain the additional information
about clinical efficacy and safety in a larger number of patients, typically at geographically dispersed clinical trial sites, to permit
the FDA to evaluate the overall benefit-risk relationship of the drug and to provide adequate information for the labeling of the drug.
In most cases the FDA requires two adequate and well-controlled Phase 3 clinical trials to demonstrate the efficacy of the drug. A single
Phase 3 clinical trial with other confirmatory evidence may be sufficient in rare instances where the trial is a large multicenter trial
demonstrating internal consistency and a statistically very persuasive finding of a clinically meaningful effect on mortality, irreversible
morbidity or prevention of a disease with a potentially serious outcome and confirmation of the result in a second trial would be practically
or ethically impossible.

The
length of time and related costs necessary to complete clinical trials varies significantly and may be difficult to predict. Clinical
trial results are frequently susceptible to varying interpretations that may delay, limit or prevent regulatory approvals. Additional
factors that can cause delay or termination of our clinical trials, or cause the costs of these clinical trials to increase, include:

● slow
patient enrollment due to the nature of the protocol, the proximity of patients to clinical
sites, the eligibility criteria for the trial, competition with clinical trials for other
drug candidates or other factors;

● inadequately
trained or insufficient personnel at the trial site to assist in overseeing and monitoring
clinical trials;

● delays
in approvals from a trial site’s IRB;

● longer
than anticipated treatment time required to demonstrate effectiveness or determine the appropriate
product dose;

● lack
of sufficient supplies of the drug candidate for use in clinical trials;

● adverse
medical events or side effects in treated patients; and

● lack
of effectiveness of the drug candidate being tested.

Any
drug is likely to produce some toxicities or undesirable side effects in animals and in humans when administered at sufficiently high
doses and/or for sufficiently long periods of time. Unacceptable toxicities or side effects may occur at any dose level, and at any time
in the course of animal studies designed to identify unacceptable effects of a drug candidate, known as toxicological studies, or in
clinical trials of our drug candidates. The appearance of any unacceptable toxicity or side effect could cause us or regulatory authorities
to interrupt, limit, delay or abort the development of any of our drug candidates and could ultimately prevent marketing approval by
the FDA or foreign regulatory authorities for any or all targeted indications.

In
addition, the manufacturer of an investigational drug in a Phase 2 or Phase 3 clinical trial for a serious or life-threatening disease
is required to make available, such as by posting on its website, its policy on evaluating and responding to requests for expanded access.

5

After
completion of the required clinical testing, an NDA or BLA is prepared and submitted to the FDA. FDA approval of the NDA or BLA is required
before marketing of the product may begin in the U.S. The NDA or the BLA must include the results of all pre-clinical, clinical and other
testing and a compilation of data relating to the product’s pharmacology, chemistry, manufacture and controls. The cost of preparing
and submitting an NDA is substantial.

The
FDA has 60 days from its receipt of an NDA or BLA to determine whether the application will be filed based on the agency’s threshold
determination that it is sufficiently complete to permit substantive review. If the NDA or BLA submission is filed, the FDA reviews the
NDA or BLA to determine, among other things, whether the proposed product is safe and effective for its intended use. The FDA has agreed
to certain performance goals in the review of NDAs or BLAs. Most such applications for standard review drug products are reviewed within
ten to twelve months; most applications for priority review drugs are reviewed in six to eight months. Priority review can be applied
to drugs that the FDA determines offer major advances in treatment or provide a treatment where no adequate therapy exists. For biologics,
priority review is further limited to drugs intended to treat a serious or life-threatening disease relative to the currently approved
products. The review process for both standard and priority review may be extended by the FDA for three additional months to consider
certain late-submitted information, or information intended to clarify information already provided in the submission.

The
FDA may also refer applications for novel drug products, or drug products that present difficult questions of safety or efficacy, to
an advisory committee – typically a panel that includes clinicians and other experts – for review, evaluation and a recommendation
as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee, but it generally
follows such recommendations. Before approving an NDA or BLA, the FDA will typically inspect one or more clinical sites to assure compliance
with GCP. Additionally, the FDA will inspect the facility or the facilities at which the drug is manufactured. The FDA will not approve
the product unless compliance with current Good Manufacturing Processes (cGMPs) is satisfactory and the NDA or BLA contains data that
provide substantial evidence that the drug is safe and effective in the indication studied.

After
the FDA evaluates the NDA or BLA and the manufacturing facilities, it issues either an approval letter or a complete response letter.
A complete response letter generally outlines the deficiencies in the submission and may require substantial additional testing, or information,
in order for the FDA to reconsider the application. If, or when, those deficiencies have been addressed to the FDA’s satisfaction
in a resubmission of the NDA or BLA, the FDA will issue an approval letter. The FDA has committed to reviewing such resubmissions in
two or six months depending on the type of information included.

An
approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. As a condition
of NDA or BLA approval, the FDA may require a risk evaluation and mitigation strategy, or REMS, to help ensure that the benefits of the
drug outweigh the potential risks. REMS can include medication guides, communication plans for healthcare professionals, and elements
to assure safe use, or ETASU. ETASU can include, but is not limited to, special training or certification for prescribing or dispensing,
dispensing only under certain circumstances, special monitoring and the use of patient registries. The requirement for a REMS can materially
affect the potential market and profitability of the drug. Moreover, product approval may require substantial post-approval testing and
surveillance to monitor the drug’s safety or efficacy. Once granted, product approvals may be withdrawn if compliance with regulatory
standards is not maintained, or problems are identified following initial marketing.

Changes
to some of the conditions established in an approved application, including changes in indications, labeling, or manufacturing processes
or facilities, require submission and FDA approval of a new NDA or BLA supplement before the change can be implemented. An NDA or BLA
supplement for a new indication typically requires clinical data similar to that in the original application, and the FDA uses the same
procedures and actions in reviewing NDA or BLA supplements as it does in reviewing NDAs or BLAs.

The
required testing, data collection, analysis and compilation of an IND and a BLA or NDA are labor intensive and costly and may take a
great deal of time. Tests may have to be redone, or new tests performed in order to comply with FDA requirements. It can take considerable
time (e.g., 5-10 years) and resources to achieve enrollment sufficient to commence such trials and complete Phase 2 or 3 clinical trials.
Moreover, there is no guarantee a product will be approved.

6

The
Orphan Drug Act provides incentives to manufacturers to develop and market drugs for rare diseases and conditions affecting fewer than
200,000 people in the U.S. at the time of application for orphan drug designation. The first developer to receive FDA marketing approval
for an orphan drug is entitled to a seven-year exclusive marketing period in the U.S. for the orphan drug indication. However, a drug
that the FDA considers to be clinically superior to, or different from, another approved orphan drug, even though for the same indication,
may also obtain approval in the U.S. during the seven-year exclusive marketing period.

Legislation
similar to the Orphan Drug Act has been enacted in other countries outside of the U.S., including the EU. The orphan legislation in the
EU is available for therapies addressing conditions that affect five or fewer out of 10,000 persons, are life-threatening or chronically
debilitating conditions and for which no satisfactory treatment is authorized. The market exclusivity period is for ten years, although
that period can be reduced to six years if, at the end of the fifth year, available evidence establishes that the product does not justify
maintenance of market exclusivity.

Expedited
Development and Review Programs

Under
the FDA Modernization Act of 1997, designation as a Fast-Track product or a breakthrough therapy for a new drug or biological product
means that the FDA will take such actions as are appropriate to The FDA has the authority to facilitate and expedite the development
and review of a drug through various programs, such as fast track designation, breakthrough therapy designation and priority review designation.
Each program may be utilized by the FDA in the context of particular circumstances. For example, fast track designation would generally
be used to facilitate the development and review of a drug that addresses an unmet medical need. Breakthrough therapy designation applies
similarly in cases where a drug demonstrates substantial improvement over existing and available therapies. Priority review designation
suggests the FDA will act on an application within six months of filing.

We
cannot guarantee that the FDA will grant any of our requests for fast track or breakthrough therapy designations, that any such designations
would affect the time of review or that the FDA will approve the NDA or BLA submitted for any of our drug candidates, whether these designations
are granted or not. Additionally, FDA approval of a fast track/breakthrough product can include restrictions on the product’s use
or distribution (such as permitting use only for specified medical conditions or limiting distribution to physicians or facilities with
special training or experience). Approval of such designated products can be conditioned on additional clinical trials after approval.

Accelerated
approval is also possible in the event a product treats a serious or life-threatening condition and provides a meaningful advantage over
available therapies. Products in this category must also meet a number of additional requirements. While a product may qualify for one
or more of the foregoing programs, the FDA reserves the right to later decide the product no longer qualifies or that the product is
no longer subject to priority regarding its review or approval.

Emergency
Use Authorization

The
FDA also has the authority to grant an Emergency Use Authorization (“EUA”) to allow unapproved medical products to be used
in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved,
and available alternatives, as designated by the U.S. government. An EUA granted by the FDA would permit a drug candidate to be able
to be distributed under the conditions set forth in the EUA prior to FDA approval. Furthermore, the FDA may revoke an EUA for a variety
of reasons, including where it is determined that the underlying health emergency no longer exists or warrants such authorizations.

Pediatric
Information

Under
the Pediatric Research Equity Act, or PREA, NDAs, BLAs or supplements to NDAs or BLAs must contain data to assess the safety and effectiveness
of the drug for the claimed indications in all relevant pediatric subpopulations and to support dosing and administration for each pediatric
subpopulation for which the drug is safe and effective. The FDA may grant full or partial waivers, or deferrals, for submission of data.
Unless otherwise required by regulation, PREA does not apply to any drug for an indication for which orphan designation has been granted,
except a product with a new active ingredient that is a molecularly targeted cancer product intended for the treatment of an adult cancer
and directed at a molecular target determined by FDA to be substantially relevant to the growth or progression of a pediatric cancer
that is subject to an NDA submitted on or after August 18, 2020.

7

The
Best Pharmaceuticals for Children Act, (“BPCA”), provides NDA holders a six-month extension of any exclusivity – patent
or non-patent – for a drug if certain conditions are met. For BLAs, the BPCA provides a six-month extension for non-patent exclusivity
if certain conditions are met. Conditions for exclusivity include the FDA’s determination that information relating to the use
of a new drug in the pediatric population may produce health benefits in that population, the FDA making a written request for pediatric
studies, and the applicant agreeing to perform, and reporting on, the requested studies within the statutory timeframe. Applications
under the BPCA are treated as priority applications, with all of the benefits that designation confers.

Disclosure
of Clinical Trial Information

Sponsors
of clinical trials of FDA-regulated products, including drugs, are required to register and disclose certain clinical trial information.
Information related to the product, patient population, phase of investigation, study sites and investigators, and other aspects of the
clinical trial is then made public as part of the registration. Sponsors are also obligated to discuss the results of their clinical
trials after completion. Disclosure of the results of these trials can be delayed in certain circumstances for up to two years after
the date of completion of the trial. Competitors may use this publicly available information to gain knowledge regarding the progress
of development programs.

The
Hatch-Waxman Amendments

Orange
Book Listing

In
seeking approval for a drug through an NDA, applicants are required to list with the FDA each patent with claims covering the applicant’s
product or method of using the product. Upon approval of a drug, each of the patents listed in the application for the drug is then published
in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Drugs listed in
the Orange Book can, in turn, be cited by potential generic competitors in support of approval of an abbreviated new drug application,
or ANDA. An ANDA provides for marketing of a drug product that has the same active ingredients in the same strengths and dosage form
as the listed drug and has been shown to be bioequivalent to the listed drug. Other than the requirement for bioequivalence testing,
ANDA applicants are not required to conduct, or submit results of, pre-clinical or clinical tests to prove the safety or effectiveness
of their drug product. Drugs approved in this way are commonly referred to as “generic equivalents” to the listed drug and
can often be substituted by pharmacists under prescriptions written for the original listed drug.

The
ANDA applicant is required to certify to the FDA concerning any patents listed for the approved product in the FDA’s Orange Book.
Specifically, the applicant must certify that: (i) the required patent information has not been filed; (ii) the listed patent has expired;
(iii) the listed patent has not expired but will expire on a particular date and approval is sought after patent expiration; or (iv)
the listed patent is invalid or will not be infringed by the new product. The ANDA applicant may also elect to submit a section viii
statement certifying that its proposed ANDA labeling does not contain (or carves out) any language regarding the patented method-of-use
rather than certify to a listed method-of-use patent. If the applicant does not challenge the listed patents, the ANDA application will
not be approved until all the listed patents claiming the referenced product have expired.

A
certification that the new product will not infringe the already approved product’s listed patents, or that such patents are invalid,
is called a Paragraph IV certification. If the ANDA applicant has provided a Paragraph IV certification to the FDA, the applicant must
also send notice of the Paragraph IV certification to the NDA and patent holders once the ANDA has been received by the FDA. The NDA
and patent holders may then initiate a patent infringement lawsuit in response to the notice of the Paragraph IV certification. The filing
of a patent infringement lawsuit within 45 days of the receipt of a Paragraph IV certification automatically prevents the FDA from approving
the ANDA until the earlier of 30 months, expiration of the patent, settlement of the lawsuit or a decision in the infringement case that
is favorable to the ANDA applicant.

The
ANDA application also will not be approved until any applicable non-patent exclusivity listed in the Orange Book for the referenced product
has expired.

8

Exclusivity

Exclusivity
provisions under the FDC Act also can delay the submission or the approval of certain applications. The FDC Act provides a five-year
period of non-patent exclusivity within the U.S. to the first applicant to gain approval of an NDA for a new chemical entity, or NCE.
A drug is entitled to NCE exclusivity if it contains a drug substance with no active moiety of which has been previously approved by
the FDA. During the exclusivity period, the FDA may not accept for review an ANDA or file a 505(b)(2) NDA submitted by another company
for another version of such drug where the applicant does not own or have a legal right of reference to all the data required for approval.
However, an application may be submitted after four years if it contains a Paragraph IV certification. The FDC Act also provides three
years of market exclusivity for an NDA, including a 505(b)(2) NDA, or supplement to an existing NDA if new clinical investigations, other
than bioavailability studies, that were conducted or sponsored by the applicant are deemed by the FDA to be essential to the approval
of the application, for example, for new indications, dosages or strengths of an existing drug. This three-year exclusivity covers only
the conditions for use associated with the new clinical investigations and does not prohibit the FDA from approving ANDAs for drugs for
the original conditions of use, such as the originally approved indication. Five-year and three-year exclusivity will not delay the submission
or approval of a full NDA; however, an applicant submitting a full NDA would be required to conduct or obtain a right of reference to
all the non-clinical studies and adequate and well-controlled clinical trials necessary to demonstrate safety and effectiveness.

Patent
Term Extension

After
NDA approval, the owner of relevant drug patent may apply for up to a five-year patent term extension. Only one patent may be extended
for each regulatory review period, which is composed of two parts: a testing phase, and an approval phase. The allowable patent term
extension is calculated as half of the drug’s testing phase – the time between the day the IND becomes effective and NDA
submission – and all of the review phase – the time between NDA submission and approval up to a maximum of five years. The
time can be shortened if the FDA determines that the applicant did not pursue approval with due diligence. The total patent term after
the extension may not exceed 14 years and only one patent may be extended.

For
patents that might expire during the application phase, the patent owner may request an interim patent extension. An interim patent extension
increases the patent term by one year and may be renewed up to four times. For each interim patent extension granted, the post-approval
patent extension is reduced by one year. The Director of the U.S. Patent and Trademark Office must determine that approval of the drug
covered by the patent for which a patent extension is being sought is likely. Interim patent extensions are not available for a drug
for which an NDA has not been submitted.

Section
505(b)(2) New Drug Applications

Most
drug products obtain FDA marketing approval pursuant to an NDA or an ANDA. A third alternative is a special type of NDA, commonly referred
to as a Section 505(b) (2), or 505(b)(2), NDA, which enables the applicant to rely, in part, on studies not conducted by, or for, the
applicant and for which the applicant has not obtained a right of reference or use, such as the FDA’s findings of safety and/or
effectiveness for a similar previously approved product, or published literature, in support of its application.

505(b)(2)
NDAs often provide an alternate path to FDA approval for new or improved formulations or new uses of previously approved products. Section
505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from studies not conducted
by, or for, the applicant and for which the applicant has not obtained a right of reference. If the 505(b)(2) applicants can establish
that reliance on the FDA’s previous approval is scientifically appropriate, it may eliminate the need to conduct certain pre-clinical
or clinical trials of the new product. The FDA may also require companies to perform additional studies or measurements to support the
change from the approved product. The FDA may then approve the new product candidate for all, or some, of the label indications for which
the referenced product has been approved, as well as for any new indication sought by the Section 505(b)(2) applicant.

9

To
the extent that the Section 505(b)(2) applicant is relying on studies conducted for an already approved product, the applicant is required
to certify to the FDA concerning any patents listed for the approved product in the Orange Book to the same extent that an ANDA applicant
would. Thus approval of a 505(b)(2) NDA can be stalled until all the listed patents claiming the referenced product have expired, until
any non-patent exclusivity, such as exclusivity for obtaining approval of a new chemical entity, listed in the Orange Book for the referenced
product has expired, and, in the case of a Paragraph IV certification and subsequent patent infringement suit, until the earlier of 30
months, settlement of the lawsuit or a decision in the infringement case that is favorable to the Section 505(b)(2) applicant.

Post-Approval
Requirements

Once
an NDA or BLA is approved, a product will be subject to certain post-approval requirements. For instance, the FDA closely regulates the
post-approval marketing and promotion of drugs, including standards and regulations for direct-to-consumer advertising, off-label promotion,
industry-sponsored scientific and educational activities and promotional activities involving the internet. Drugs may be marketed only
for the approved indications and in accordance with the provisions of the approved labeling.

Adverse
event reporting and submission of periodic reports are required following FDA approval of an NDA or BLA. The FDA also may require post-marketing
testing, known as Phase 4 testing, REMS, and surveillance to monitor the effects of an approved product, or the FDA may place conditions
on an approval that could restrict the distribution or use of the product. In addition, quality-control, drug manufacture, packaging
and labeling procedures must continue to conform to cGMPs after approval. Drug manufacturers and certain of their subcontractors are
required to register their establishments with the FDA and certain state agencies. Registration with the FDA subjects’ entities to periodic
unannounced inspections by the FDA, during which the agency inspects manufacturing facilities to assess compliance with cGMPs. Accordingly,
manufacturers must continue to expend time, money and effort in the areas of production and quality control to maintain compliance with
cGMPs. Regulatory authorities may withdraw product approvals or request product recalls if a company fails to comply with regulatory
standards, if it encounters problems following initial marketing or if previously unrecognized problems are subsequently discovered.
In addition, prescription drug manufacturers in the United States must comply with applicable provisions of the Drug Supply Chain Security
Act and provide and receive product tracing information, maintain appropriate licenses, ensure they only work with other properly licensed
entities, and have procedures in place to identify and properly handle suspect and illegitimate products.

Failure
to comply with the applicable FDA requirements may subject manufacturers and distributors to administrative or judicial sanctions. These
sanctions could include, among other things, warning letters, product seizures, total or partial suspension of production or distribution,
injunctions, civil money penalties, fines, restitution, disgorgement, or civil or criminal penalties. Further, the FDA has authority
to issue mandatory recalls for medical devices and biologics, and we may need to undertake a voluntary recall for any of our products.

In
addition to regulations enforced by the FDA, we are also subject to regulation under the Occupational Safety and Health Act, the Environmental
Protection Act, the Toxic Substances Control Act, the Resource Conservation and Recovery Act and other federal, state and local regulations.
Our research and development activities involve the controlled use of hazardous materials, chemicals, biological materials and radioactive
compounds.

Biologics
Regulation

Biological
products used for the prevention, treatment or cure of a disease or condition of a human being are subject to regulation under the FDC
Act, except the section of the FDC Act which governs the approval of NDAs. Biological products are approved for marketing under provisions
of the Public Health Service Act, or PHSA, via a BLA. However, the application process and requirements for approval of BLAs are very
similar to those for NDAs, and biologics are associated with similar approval risks and costs as drugs. To help reduce the increased
risk of the introduction of adventitious agents, the PHSA emphasizes the importance of manufacturing controls for products whose attributes
cannot be precisely defined. The PHSA also provides authority to the FDA to immediately suspend licenses in situations where there exists
a danger to public health, to prepare or procure products in the event of shortages and critical public health needs, and to authorize
the creation and enforcement of regulations to prevent the introduction or spread of communicable diseases in the US and between states.

10

After
a BLA is approved, the product may also be subject to official lot release as a condition of approval. As part of the manufacturing process,
the manufacturer is required to perform certain tests on each lot of the product before it is released for distribution. If the product
is subject to official release by the FDA, the manufacturer submits samples of each lot of products to the FDA together with a release
protocol showing a summary of the history of manufacture of the lot and the results of all of the manufacturer’s tests performed
on the lot. The FDA may also perform certain confirmatory tests on lots of some products, such as viral vaccines, before releasing the
lots for distribution by the manufacturer. In addition, the FDA conducts laboratory research related to the regulatory standards on the
safety, purity, potency, and effectiveness of biological products. As with drugs, after approval of biologics, manufacturers must address
any safety issues that arise, are subject to recalls or a halt in manufacturing, and are subject to periodic inspection after approval.

The
Biologics Price Competition and Innovation Act of 2009, or BPCIA, creates an abbreviated approval pathway for biological products shown
to be highly similar to, or interchangeable with, an FDA-licensed reference biological product. Biosimilarity sufficient to reference
a prior FDA-approved product requires that there be no differences in conditions of use, route of administration, dosage form, and strength,
and no clinically meaningful differences between the biological product and the reference product in terms of safety, purity and potency.
Biosimilarity must be shown through analytical studies, animal studies, and at least one clinical trial, absent a waiver by the Secretary.
A biosimilar product may be deemed interchangeable with a prior approved product if it meets the higher hurdle of demonstrating that
it can be expected to produce the same clinical results as the reference product and, for products administered multiple times, the biologic
and the reference biologic may be switched after one has been previously administered without increasing safety risks or risks of diminished
efficacy relative to exclusive use of the reference biologic. To date, only four biosimilar products and no interchangeable products
have been approved under the BPCIA. Complexities associated with the larger, and often more complex, structures of biological products,
as well as the process by which such products are manufactured, particularly with respect to interchangeability, are still being evaluated
by the FDA.

A
reference biologic is granted twelve years of exclusivity from the time of first licensure of the reference product, and no application
for a biosimilar can be submitted for four years from the date of licensure of the reference product. The first biologic product submitted
under the abbreviated approval pathway that is determined to be interchangeable with the reference product has exclusivity against a
finding of interchangeability for other biologics for the same condition of use for the lesser of (i) one year after first commercial
marketing of the first interchangeable biosimilar, (ii) eighteen months after the first interchangeable biosimilar is approved if there
is no patent challenge, (iii) eighteen months after resolution of a lawsuit over the patents of the reference biologic in favor of the
first interchangeable biosimilar applicant, or (iv) 42 months after the first interchangeable biosimilar’s application has been
approved if a patent lawsuit is ongoing within the 42-month period.

Regulation
Outside the United States

In
order to market any product outside of the U.S., a company must also comply with numerous and varying regulatory requirements of other
countries and jurisdictions regarding quality, safety and efficacy and governing, among other things, clinical trials, marketing authorization,
commercial sales and distribution of drug products. Whether or not it obtains FDA approval for a product, the company would need to obtain
the necessary approvals by the comparable foreign regulatory authorities before it can commence clinical trials or marketing of the product
in those countries or jurisdictions. The approval process ultimately varies between countries and jurisdictions and can involve additional
product testing and additional administrative review periods. The time required to obtain approval in other countries and jurisdictions
might differ from and be longer than that required to obtain FDA approval. Regulatory approval in one country or jurisdiction does not
ensure regulatory approval in another, but a failure or delay in obtaining regulatory approval in one country or jurisdiction may negatively
impact the regulatory process in others.

Regulation
and Marketing Authorization in the European Union

The
process governing approval of medicinal products in the European Union follows essentially the same lines as in the United States and,
likewise, generally involves satisfactorily completing each of the following:

● pre-clinical
laboratory tests, animal studies and formulation studies all performed in accordance with
the applicable EU Good Laboratory Practice regulations;

● submission
to the relevant national authorities of a clinical trial application, or CTA, which must
be approved before human clinical trials may begin;

● performance
of adequate and well-controlled clinical trials to establish the safety and efficacy of the
product for each proposed indication;

● submission
to the relevant competent authorities of a marketing authorization application, or MAA, which
includes the data supporting safety and efficacy as well as detailed information on the manufacture
and composition of the product in clinical development and proposed labeling;

● satisfactory
completion of an inspection by the relevant national authorities of the manufacturing facility
or facilities, including those of third parties, at which the product is produced to assess
compliance with strictly enforced current cGMP;

● potential
audits of the non-clinical and clinical trial sites that generated the data in support of
the MAA; and

● review
and approval by the relevant competent authority of the MAA before any commercial marketing,
sale or shipment of the product.

Pre-Clinical
Studies

Pre-clinical
tests include laboratory evaluations of product chemistry, formulation and stability, as well as studies to evaluate toxicity in animal
studies, in order to assess the potential safety and efficacy of the product. The conduct of the pre-clinical tests and formulation of
the compounds for testing must comply with the relevant EU regulations and requirements. The results of the pre-clinical tests, together
with relevant manufacturing information and analytical data, are submitted as part of the CTA.

Clinical
Trial Approval

Requirements
for the conduct of clinical trials in the European Union including GCP are implemented in the Clinical Trials Directive 2001/20/EC and
the GCP Directive 2005/28/EC. Pursuant to Directive 2001/20/EC and Directive 2005/28/EC, as amended, a system for the approval of clinical
trials in the European Union has been implemented through national legislation of the member states. Under this system, approval must
be obtained from the competent national authority of an EU member state in which a study is planned to be conducted, or in multiple member
states if the clinical trial is to be conducted in a number of member states. To this end, a CTA is submitted, which must be supported
by an investigational medicinal product dossier, or IMPD, and further supporting information prescribed by Directive 2001/20/EC and Directive
2005/28/EC and other applicable guidance documents. Furthermore, a clinical trial may only be started after a competent ethics committee
has issued a favorable opinion on the clinical trial application in that country.

In
2019 new Regulation (EU) No 536/2014 became applicable and aims to simplify and streamline the approval of clinical trials in the European
Union. The main characteristics of the regulation include:

● A
streamlined application procedure via a single-entry point, the EU portal.

● A
single set of documents to be prepared and submitted for the application as well as simplified
reporting procedures that will spare sponsors from submitting broadly identical information
separately to various bodies and different member states.

● A
harmonized procedure for the assessment of applications for clinical trials, which is divided
into two parts. Part I is assessed jointly by all member states concerned. Part II is assessed
separately by each member state concerned.

● Strictly
defined deadlines for the assessment of clinical trial application.

● The
involvement of the ethics committees in the assessment procedure in accordance with the national
law of the member state concerned but within the overall timelines defined by the Regulation
(EU) No 536/2014.

Marketing
Authorization

Authorization
to market a product in the member states of the European Union proceeds under one of four procedures: a centralized authorization procedure,
a mutual recognition procedure, a decentralized procedure, or a national procedure.

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Centralized
Authorization Procedure

The
centralized procedure enables applicants to obtain a marketing authorization that is valid in all EU member states based on a single
application. Certain medicinal products, including products developed by means of biotechnological processes, must undergo the centralized
authorization procedure for marketing authorization, which, if granted by the European Commission, is automatically valid in all 28 EU
member states. The EMA and the European Commission administer this centralized authorization procedure pursuant to Regulation (EC) No
726/2004.

Pursuant
to Regulation (EC) No 726/2004, this procedure is mandatory for:

● medicinal
products developed by means of one of the following biotechnological processes;

● recombinant
DNA technology;

● controlled
expression of genes coding for biologically active proteins in prokaryotes and eukaryotes
including transformed mammalian cells;

● hybridoma
and monoclonal antibody methods;

● advanced
therapy medicinal products as defined in Article 2 of Regulation (EC) No. 1394/2007 on advanced
therapy medicinal products;

● medicinal
products for human use containing a new active substance that, on the date of effectiveness
of this regulation, was not authorized in the European Union, and for which the therapeutic
indication is the treatment of any of the following diseases;

● acquired
immune deficiency syndrome;

● cancer;

● neurodegenerative
disorder;

● diabetes;

● auto-immune
diseases and other immune dysfunctions;

● viral
diseases; and

● medicinal
products that are designated as orphan medicinal products pursuant to Regulation (EC) No
141/2000.

The
centralized authorization procedure is optional for other medicinal products if they contain a new active substance or if the applicant
shows that the medicinal product concerned constitutes a significant therapeutic, scientific or technical innovation or that the granting
of authorization is in the interest of patients in the European Union.

Administrative
Procedure

Under
the centralized authorization procedure, the EMA’s Committee for Human Medicinal Products, or CHMP, serves as the scientific committee
that renders opinions about the safety, efficacy, and quality of medicinal products for human use on behalf of the EMA. The CHMP is composed
of experts nominated by each member state’s national authority for medicinal products, with an expert appointed to act as Rapporteur
for the co-ordination of the evaluation with the possible assistance of a further member of the Committee acting as a Co-Rapporteur.
After approval, the Rapporteur(s) continue to monitor the product throughout its life cycle. The CHMP has 210 days to adopt an opinion
as to whether a marketing authorization should be granted. The process usually takes longer in case additional information is requested,
which triggers clock-stops in the procedural timelines. The process is complex and involves extensive consultation with the regulatory
authorities of member states and a number of experts. When an application is submitted for a marketing authorization in respect of a
drug that is of major interest from the point of view of public health and in particular from the viewpoint of therapeutic innovation,
the applicant may be pursuant to Article 14(9) Regulation (EC) No 726/2004 request an accelerated assessment procedure. If the CHMP accepts
such request, the time-limit of 210 days will be reduced to 150 days, but it is possible that the CHMP can revert to the standard time-limit
for the centralized procedure if it considers that it is no longer appropriate to conduct an accelerated assessment. Once the procedure
is completed, a European Public Assessment Report, or EPAR, is produced. If the opinion is negative, information is given as to the grounds
on which this conclusion was reached. After the adoption of the CHMP opinion, a decision on the MAA must be adopted by the European Commission,
after consulting the E.U. member states, which in total can take more than 60 days.

12

Conditional
Approval

In
specific circumstances, EU legislation (Article 14(7) Regulation (EC) No 726/2004 and Regulation (EC) No 507/2006 on Conditional Marketing
Authorizations for Medicinal Products for Human Use) enables applicants to obtain a conditional marketing authorization prior to obtaining
the comprehensive clinical data required for an application for a full marketing authorization. Such conditional approvals may be granted
for product candidates (including medicines designated as orphan medicinal products) if (1) the risk-benefit balance of the product candidate
is positive, (2) it is likely that the applicant will be in a position to provide the required comprehensive clinical trial data, (3)
the product fulfills unmet medical needs and (4) the benefit to public health of the immediate availability on the market of the medicinal
product concerned outweighs the risk inherent in the fact that additional data are still required. A conditional marketing authorization
may contain specific obligations to be fulfilled by the marketing authorization holder, including obligations with respect to the completion
of ongoing or new studies, and with respect to the collection of pharmacovigilance data. Conditional marketing authorizations are valid
for one year, and may be renewed annually, if the risk-benefit balance remains positive, and after an assessment of the need for additional
or modified conditions and/or specific obligations. The timelines for the centralized procedure described above also apply with respect
to the review by the CHMP of applications for a conditional marketing authorization.

Marketing
Authorization under Exceptional Circumstances

Under
Article 14(8) Regulation (EC) No 726/2004, products for which the applicant can demonstrate that comprehensive data (in line with the
requirements laid down in Annex I of Directive 2001/83/EC, as amended) cannot be provided (due to specific reasons foreseen in the legislation)
might be eligible for marketing authorization under exceptional circumstances. This type of authorization is reviewed annually to reassess
the risk-benefit balance. The fulfillment of any specific procedures/obligations imposed as part of the marketing authorization under
exceptional circumstances is aimed at the provision of information on the safe and effective use of the product and will normally not
lead to the completion of a full dossier/approval.

Market
Authorizations Granted by Authorities of EU Member States

In
general, if the centralized procedure is not followed, there are three alternative procedures as prescribed in Directive 2001/83/EC:

● The
decentralized procedure allows applicants to file identical applications to several EU member
states and receive simultaneous national approvals based on the recognition by EU member
states of an assessment by a reference member state.

● The
national procedure is only available for products intended to be authorized in a single EU
member state.

● A
mutual recognition procedure similar to the decentralized procedure is available when a marketing
authorization has already been obtained in at least one E.U. member state.

A
marketing authorization may be granted only to an applicant established in the EU.

Pediatric
Studies

Prior
to obtaining a marketing authorization in the European Union, applicants have to demonstrate compliance with all measures included
in an EMA-approved Pediatric Investigation Plan, or PIP, covering all subsets of the pediatric population, unless the EMA has
granted a product-specific waiver, a class waiver, or a deferral for one or more of the measures included in the PIP. The respective
requirements for all marketing authorization procedures are set forth in Regulation (EC) No 1901/2006, which is referred to as the
Pediatric Regulation. This requirement also applies when a company wants to add a new indication, pharmaceutical form or route of
administration for a medicine that is already authorized. The Pediatric Committee of the EMA, or PDCO, may grant deferrals for some
medicines, allowing a company to delay development of the medicine in 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 in children is not needed or is
not appropriate, such as for diseases that only affect the elderly population.

Before
a marketing authorization application can be filed, or an existing marketing authorization can be amended, the EMA determines that companies
actually comply with the agreed studies and measures listed in each relevant PIP.

13

Periods
of Authorization and Renewals

A
marketing authorization is valid for five years in principle and the marketing authorization may be renewed after five years on the basis
of a re-evaluation of the risk-benefit balance by the EMA or by the competent authority of the authorizing member state. To this end,
the marketing authorization holder must provide the EMA or the competent authority 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 ceases to be valid. Once renewed, the marketing authorization is valid for an unlimited period, unless
the European Commission or the competent authority decides on justified grounds relating to pharmacovigilance, to proceed with one additional
five-year renewal. Any authorization which is not followed by the actual placing of the drug on the EU market (in case of centralized
procedure) or on the market of the authorizing member state within three years after authorization ceases to be valid (the so-called
sunset clause).

Regulatory
Data Protection

EU
legislation also provides for a system of regulatory data and market exclusivity. According to Article 14(11) of Regulation (EC) No 726/2004,
as amended, and Article 10(1) of Directive 2001/83/EC, as amended, upon receiving marketing authorization, new chemical entities approved
on the basis of complete independent data package benefit from eight years of data exclusivity and an additional two years of market
exclusivity. Data exclusivity prevents regulatory authorities in the European Union from referencing the innovator’s data to assess
a generic (abbreviated) application. During the additional two-year period of market exclusivity, a generic marketing authorization can
be submitted, and the innovator’s data may be referenced, but no generic medicinal product can be marketed until the expiration
of the market exclusivity. The overall ten-year period will be extended to a maximum of 11 years if, during the first eight years of
those ten years, the marketing authorization holder, or MAH, obtains an authorization for one or more new therapeutic indications which,
during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit in comparison with existing
therapies. Even if a compound is considered to be a new chemical entity and the innovator is able to gain the period of data exclusivity,
another company nevertheless could also market another version of the drug if such company obtained marketing authorization based on
an MAA with a complete independent data package of pharmaceutical test, pre-clinical tests and clinical trials. However, products designated
as orphan medicinal products enjoy, upon receiving marketing authorization, a period of ten years of orphan market exclusivity. Depending
upon the timing and duration of the EU marketing authorization process, products may be eligible for up to five years’ supplementary
protection certificates, or SPCs, pursuant to Regulation (EC) No 469/2009. Such SPCs extend the rights under the basic patent for the
drug.

Regulatory
Requirements After Marketing Authorization has been Obtained

If
we obtain authorization for a medicinal product in the EU, we will be required to comply with a range of requirements applicable to the
manufacturing, marketing, promotion and sale of medicinal products:

Pharmacovigilance
and Other Requirements

We
are required to comply with the EU’s stringent pharmacovigilance or safety reporting rules, pursuant to which post-authorization
studies and additional monitoring obligations can be imposed. Other requirements relate, for example, to the manufacturing of products
and APIs in accordance with good manufacturing practice standards. EU regulators may conduct inspections to verify our compliance with
applicable requirements, and we will have to continue to expend time, money and effort to remain compliant. Non-compliance with EU requirements
regarding safety monitoring or pharmacovigilance, and with requirements related to the development of products for the pediatric population,
can also result in significant financial penalties in the European Union. Similarly, failure to comply with the EU’s requirements
regarding the protection of individual personal data can also lead to significant penalties and sanctions. Individual EU member states
may also impose various sanctions and penalties in case we do not comply with locally applicable requirements.

14

Manufacturing

The
manufacturing of authorized drugs, for which a separate manufacturer’s license is mandatory, must be conducted in strict compliance
with the EMA’s Good Manufacturing Practices, or GMP, requirements and comparable requirements of other regulatory bodies in the
European Union, which mandate the methods, facilities and controls used in manufacturing, processing and packing of drugs to assure their
safety and identity. The EMA enforces its current GMP requirements through mandatory registration of facilities and inspections of those
facilities. The EMA may have a coordinating role for these inspections while the responsibility for carrying them out rests with the
member states competent authority under whose responsibility the manufacturer falls. Failure to comply with these requirements could
interrupt supply and result in delays, unanticipated costs and lost revenues, and could subject the applicant to potential legal or regulatory
action, including but not limited to warning letters, suspension of manufacturing, seizure of product, injunctive action or possible
civil and criminal penalties.

Marketing
and Promotion

The
marketing and promotion of authorized drugs, including industry-sponsored continuing medical education and advertising directed toward
the prescribers of drugs and/or the general public, are strictly regulated in the EU under Directive 2001/83/EC. The applicable regulations
aim to ensure that information provided by holders of marketing authorizations regarding their products is truthful, balanced and accurately
reflects the safety and efficacy claims authorized by the EMA or by the competent authority of the authorizing member state. Failure
to comply with these requirements can result in adverse publicity, warning letters, corrective advertising and potential civil and criminal
penalties.

Patent
Term Extension

In
order to compensate the patentee for delays in obtaining a marketing authorization for a patented product, a supplementary certificate,
or SPC, may be granted extending the exclusivity period for that specific product by up to five years. Applications for SPCs must be
made to the relevant patent office in each EU member state and the granted certificates are valid only in the member state of grant.
An application has to be made by the patent owner within six months of the first marketing authorization being granted in the EU (assuming
the patent in question has not expired, lapsed or been revoked) or within six months of the grant of the patent (if the marketing authorization
is granted first). In the context of SPCs, the term “product” means the active ingredient or combination of active ingredients
for a medicinal product and the term “patent” means a patent protecting such a product or a new manufacturing process or
application for it. The duration of an SPC is calculated as the difference between the patent’s filing date and the date of the
first marketing authorization, minus five years, subject to a maximum term of five years.

A
six-month pediatric extension of an SPC may be obtained where the patentee has carried out an agreed pediatric investigation plan, the
authorized product information includes information on the results of the studies, and the product is authorized in all member states
of the European Union.

Pharmaceutical
Coverage, Pricing and Reimbursement

Significant
uncertainty exists as to the coverage and reimbursement status of products approved by the FDA and other government authorities. Sales
of products will depend, in part, on the extent to which the costs of the products will be covered by third-party payors, including government
health programs in the U.S. such as Medicare and Medicaid, commercial health insurers and managed care organizations. The process for
determining whether a payor will provide coverage for a product may be separate from the process for setting the price or reimbursement
rate that the payor will pay for the product once coverage is approved. Third-party payors may limit coverage to specific products on
an approved list, or formulary, which might not include all of the approved products for a particular indication.

In
order to secure coverage and reimbursement for any product that might be approved for sale, a company may need to conduct expensive pharmacoeconomic
studies in order to demonstrate the medical necessity and cost-effectiveness of the product, in addition to the costs required to obtain
FDA or other comparable regulatory approvals. A payor’s decision to provide coverage for a drug product does not imply that an
adequate reimbursement rate will be approved. Third-party reimbursement may not be sufficient to maintain price levels high enough to
realize an appropriate return on investment in product development.

15

There
has been an increased focus on drug pricing in recent years in the U.S. Although there are no direct government price controls over private
sector purchases in the U.S., there are rebates and other financial requirements for federal and state health care programs. The Medicare
Modernization Act, enacted in December 2003, established the Medicare Part D outpatient prescription drug benefit, which is provided
primarily through private entities that attempt to negotiate price concessions from pharmaceutical manufacturers. The health care reform
legislation enacted in 2010, known as the Affordable Care Act, requires drug manufacturers to pay 50% of the Medicare Part D coverage
gap, also known as the “donut hole,” on prescriptions for branded products filled when the beneficiary reaches this coverage.
The Deficit Reduction Act of 2005 resulted in changes to the way drug prices are reported to the government and the formula using such
information to calculate the required Medicaid rebates. The Affordable Care Act increased the minimum basic Medicaid rebate for branded
prescription drugs from 15.1% to 23.1% and requires pharmaceutical manufacturers to pay states rebates on prescription drugs dispensed
to Medicaid managed care enrollees. In addition, the Affordable Care Act increased the additional Medicaid rebate on “line extensions”
(such as extended-release formulations) of solid oral dosage forms of branded products, revised the definition of average manufacturer
price by changing the classes of purchasers included in the calculation, and expanded the entities eligible for discounted pricing under
the federal 340B drug pricing program. Current orphan drugs are excluded from the expanded 340B hospitals eligible for discounts.

The
Affordable Care Act imposes a significant annual fee on companies that manufacture or import branded prescription drug products. The
fee (which is not deductible for federal income tax purposes) is based on the manufacturer’s market share of sales of branded drugs
and biologics (excluding orphan drugs) to, or pursuant to coverage under, specified U. S. government programs. The Affordable Care Act
also contains a number of provisions, including provisions governing the way that health care is financed by both governmental and private
insurers, enrollment in federal health care programs, reimbursement changes, the increased use of comparative effectiveness research
in health care decision-making, and enhancements to fraud and abuse requirements and enforcement, that are affecting existing government
health care programs and will result in the development of new programs. The Affordable Care Act also contains requirements for manufacturers
to publicly report certain payments or other transfers of value made to physicians and teaching hospitals. We are unable to predict the
future course of federal or state health care legislation and regulations, including regulations that will be issued to implement provisions
of the Affordable Care Act. The Affordable Care Act and further changes in the law or regulatory framework that reduce our revenues or
increase our costs could also have a material adverse effect on our business, financial condition and results of operations and cash
flows.

Public
and private health care payers control costs and influence drug pricing through a variety of mechanisms, including through negotiating
discounts with the manufacturers and through the use of tiered formularies and other mechanisms that provide preferential access to certain
drugs over others within a therapeutic class. Payers also set other criteria to govern the uses of a drug that will be deemed medically
appropriate and therefore reimbursed or otherwise covered. Payers may require physicians to seek approval from them before a product
will be reimbursed or covered, commonly referred to as prior authorization. In particular, many public and private health care payers
limit reimbursement and coverage to the uses of a drug that are either approved by the FDA or appear in a recognized drug compendium.
Drug compendia are publications that summarize the available medical evidence for particular drug products and identify which uses of
a drug are supported or not supported by the available evidence, whether or not such uses have been approved by the FDA. For example,
in the case of Medicare Part D coverage for oncology drugs, the Medicare Modernization Act, with certain exceptions, provides for Medicare
coverage of unapproved uses of an FDA-approved drug if the unapproved use is reasonable and necessary and is supported by one or more
citations in CMS-approved compendia, such as the National Comprehensive Cancer Network Drugs and Biologics Compendium. Different pricing
and reimbursement schemes exist in other countries. For example, in the European Union, governments influence the price of pharmaceutical
products through their pricing and reimbursement rules and control of national health care systems that fund a large part of the cost
of such products to consumers. The approach taken varies from member state to member state. Some jurisdictions operate positive or negative
list systems under which products may only be marketed once a reimbursement price has been agreed. Other member states allow companies
to fix their own prices for medicines but monitor and control company profits and may limit or restrict reimbursement. The downward
pressure on health care costs in general, and prescription drugs in particular, has become very intense. As a result, increasingly high
barriers are being erected to the entry of new products, as exemplified by the actions of the National Institute for Clinical Excellence
in the U.K., which evaluates the data supporting new medicines and passes reimbursement recommendations to the government. In addition,
in some countries cross-border imports from low-priced markets (parallel imports) exert commercial pressure on pricing within a country.

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In
the EU, pricing and reimbursement schemes vary widely from country to country. Some countries provide that drug products may be marketed
only after a reimbursement price has been agreed. Some countries may require the completion of additional studies that compare the cost-effectiveness
of our drug candidate to currently available therapies (so called health technology assessment) in order to obtain reimbursement or pricing
approval. For example, the EU provides options for its member states to restrict the range of drug products for which their national
health insurance systems provide reimbursement and to control the prices of medicinal products for human use. EU member states may approve
a specific price for a drug product, or it may instead adopt a system of direct or indirect controls on the profitability of the company
placing the drug product on the market. Other member states allow companies to fix their own prices for drug products but monitor and
control prescription volumes and issue guidance to physicians to limit prescriptions. The downward pressure on health care costs in general,
particularly prescription drugs, has become intense. As a result, increasingly high barriers are being erected to the entry of new products.
In addition, there can be considerable pressure from governments and other stakeholders on prices and reimbursement levels, including
as part of cost containment measures. Political, economic and regulatory developments may further complicate pricing negotiations, and
pricing negotiations may continue after reimbursement has been obtained. Reference pricing used by various EU member states, and parallel
distribution (arbitrage between low-priced and high-priced member states), can further reduce prices. Any country that has price controls
or reimbursement limitations for drug products may not allow favorable reimbursement and pricing arrangements.

Healthcare
Law and Regulation

Healthcare
providers, physicians and third-party payors play a primary role in the recommendation and prescription of drug products that are granted
marketing approval. Arrangements with third-party payors and customers are subject to broadly applicable fraud and abuse and other healthcare
laws and regulations. Such restrictions under applicable federal and state healthcare laws and regulations include the following:

● the
federal Anti-Kickback Statute prohibits, among other things, persons from knowingly and willfully
soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash
or in kind, to induce or reward either the referral of an individual for, or the purchase,
order or recommendation of, any good or service, for which payment may be made, in whole
or in part, under a federal healthcare program such as Medicare and Medicaid;

● the
federal False Claims Act imposes civil penalties, and provides for civil whistleblower or
qui tam actions, against individuals or entities for knowingly presenting, or causing to
be presented, to the federal government, claims for payment that are false or fraudulent
or making a false statement to avoid, decrease or conceal an obligation to pay money to the
federal government.

● the
federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, imposes criminal
and civil liability for executing a scheme to defraud any healthcare benefit program or making
false statements relating to healthcare matters;

● HIPAA,
as amended by the Health Information Technology for Economic and Clinical Health Act and
its implementing regulations, also imposes obligations, including mandatory contractual terms,
with respect to safeguarding the privacy, security and transmission of individually identifiable
health information;

● the
federal false statements prohibit knowingly and willfully falsifying, concealing or covering
up a material fact or making any materially false statement in connection with the delivery
of or payment for healthcare benefits, items or services;

● the
federal transparency requirements under the Health Care Reform Law requires manufacturers
of drugs, devices, biologics and medical supplies to report to the Department of Health and
Human Services information related to payments and other transfers of value to physicians
and teaching hospitals and physician ownership and investment interests; and

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

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An
increasing number of states have enacted legislation requiring pharmaceutical and biotechnology companies to file periodic reports of
expenses relating to the marketing and promotion of drug products and gifts and payments to individual healthcare practitioners in these
states; to make periodic public disclosures on sales, marketing, pricing, clinical trials and other activities; to report information
pertaining to and justifying price increases; or to register their sales representatives. Other states prohibit various marketing-related
activities, such as the provision of certain kinds of gifts or meals; price gouging; or pharmacies and other healthcare entities from
providing certain physician prescribing data to pharmaceutical and biotechnology companies for use in sales and marketing. In addition,
states such as California, Connecticut, Nevada, and Massachusetts require pharmaceutical companies to implement compliance programs and/or
marketing codes. State and foreign laws also govern the privacy and security of health information in some circumstances, many of which
differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.

Environmental,
Health and Safety Matters

The
manufacturing facilities of the third-parties that develop our product candidates are subject to extensive environmental, health and
safety laws and regulations in a number of jurisdictions, governing, among other things: the use, storage, registration, handling, emission
and disposal of chemicals, waste materials and sewage; chemicals, air, water and ground contamination; air emissions and the cleanup
of contaminated sites, including any contamination that results from spills due to our failure to properly dispose of chemicals, waste
materials and sewage.

These
laws, regulations and permits could potentially require the expenditure by us of significant amounts for compliance or remediation if,
among other things, our operations result in contamination of the environment or breach of regulatory obligations or expose individuals
to harm. If the third-party manufacturers fail to comply with such laws, regulations or permits, we may be subject to fines and other
civil, administrative or criminal sanctions, including the revocation of permits and licenses necessary to continue our business activities.
In addition, we may be required to pay damages or civil judgments in respect of third-party claims, including those relating to personal
injury (including exposure to hazardous substances we use, store, handle, transport, manufacture or dispose of), property damage or contribution
claims. Some environmental, health and safety laws allow for strict, joint and several liability for remediation costs, regardless of
comparative fault. We may be identified as a responsible party under such laws. Such developments could have a material adverse effect
on our business, financial condition and results of operations.

In
addition, laws and regulations relating to environmental, health and safety matters are often subject to change. In the event of any
changes or new laws or regulations, we could be subject to new compliance measures or to penalties for activities that were previously
permitted.

Competition

Our
industry is subject to rapid and intense technological change. Competition is intense among manufacturers of nutritional, non-prescription,
and prescription pharmaceuticals. We face, and will continue to face, competition from nutraceutical, pharmaceutical, biopharmaceutical,
medical device and biotechnology companies developing similar products and technologies both in the United States and abroad, as well
as numerous academic and research institutions, governmental agencies and private organizations engaged in drug funding or research and
discovery activities both in the United States and abroad. Academic institutions, government agencies and other public and private research
organizations may also conduct research, seek patent protection and establish collaborative arrangements for discovery, research and
clinical development of technologies and products similar to ours. We also face competition from entities and healthcare providers using
more traditional methods. We believe there are a substantial number of products under development by numerous nutraceuticals, pharmaceutical,
biopharmaceutical, medical device and biotechnology companies, and it is likely that other competitors will emerge.

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Many
of our existing and potential competitors are large, well-established pharmaceutical, chemical or healthcare companies with considerably
greater research and product development capabilities and financial, scientific, marketing and human resources than we have. Large and
established companies, such as Merck & Co., Inc., GlaxoSmithKline plc, CSL Ltd., Sanofi Pasteur, SA, Pfizer Inc., Johnson & Johnson,
AstraZeneca, and Moderna, among others, compete in the same or similar markets. In particular, these companies have greater experience
and expertise in securing government contracts and grants to support their research and development efforts, conducting testing and clinical
trials, obtaining regulatory approvals to market products, manufacturing such products on a broad scale and marketing approved products.
As a result, these competitors may succeed in developing competing products earlier than we do; obtain patents that block or otherwise
inhibit our ability to further develop and commercialize our product candidates; obtain approvals from the FDA or other regulatory agencies
for products more rapidly than we do; or develop treatments or cures that are safer or more effective than those we propose to develop.
These competitors may also devote greater resources to marketing or selling their products and may be better able to withstand price
competition. In addition, these competitors may introduce or adapt more quickly to new technologies or scientific advances, which could
render our technologies obsolete, and may introduce products or technologies that make the continued development, production, or marketing
of our product candidates uneconomical. These competitors may also be more successful in negotiating third-party licensing or collaborative
arrangements and may be able to take advantage of acquisitions or other strategic opportunities more readily than we can. These actions
by competitors or potential competitors could materially affect our business, financial condition and results of operations. We cannot
assure you that we will be able to compete successfully.

Regardless
of the disease, smaller or early-stage companies and research institutions also may prove to be significant competitors, particularly
through collaborative arrangements with large and established pharmaceutical companies. As these companies develop their technologies,
they may develop proprietary positions, which may prevent or limit our product development and commercialization efforts. We will also
face competition from these parties in recruiting and retaining qualified scientific and management personnel, establishing clinical
trial sites and participant registration for clinical trials and in acquiring and in-licensing technologies and products complementary
to our programs or potentially advantageous to our business. If any of our competitors succeed in obtaining approval from the FDA or
other regulatory authorities for their products sooner than we do or for products that are more effective or less costly than ours, our
commercial opportunity could be significantly reduced.

We
have limited ability to predict how competitive our products and product candidates will be in the marketplace.

Our
Intellectual Property

Our
success will depend in part on our ability to obtain and maintain patents and other proprietary protection for our technology, inventions,
improvements, and know-how related to the business; to defend and enforce proprietary rights, including any patents that we may own or
have rights to in the future; to preserve the confidentiality of our trade secrets and other intellectual property; to obtain and maintain
licenses to use intellectual property owned by third parties; and to operate without infringing valid and enforceable patents and other
proprietary rights of third parties. Our ability to stop third parties from making, using, selling, offering to sell, exporting, and/or
importing our products and methods may depend on the extent to which we have rights under valid and enforceable patents and/or trade
secrets that cover these activities. With respect to both licensed and company-owned intellectual property, we cannot be sure that patents
will be granted with respect to any of our pending patent applications or with respect to any patent applications filed in the future,
nor can we be sure that any of our existing patents or any patents that may be granted in the future will be commercially useful in protecting
our commercial products and methods of using and/or manufacturing the same, or will be held invalid, unenforceable or not infringed.

Patents

We
attempt to protect our technology, innovations, and products through patents, patent applications, and trade secrets and know-how. As
part of the December 2023 acquisition of ONP-002 and related intellectual property, we acquired rights to numerous patent properties
for ONP-002 which have been filed and/or issued and a right to multiple patent applications that have been filed worldwide on the novel
Breadth-Powered Nasal Delivery Devices and Uses Thereof.

Patent
applications that concern ONP-002 and the nasal delivery device have been filed as follows:

● New
chemical entity patent filings concerning the C-20 steroid compounds haves been filed with
the USPTO and are pending in the U.S. To date, national patents in 9 different countries
have been granted, including European countries and Canada and Philippines. A bundle of
patents under the European Patent Convention have also been granted, namely, France, Germany,
Ireland, Italy, Spain, Switzerland and UK.

○ C-20
steroid compounds, composition and uses thereof to treat traumatic brain injury (TBI), including
concussion.

○
Inventions relate to, inter alia, ONP-002 compositions, methods of use to treat and/or, minimize traumatic brain injury (TBI),
including severe TBI, moderate TBI, and mild TBI, including concussions, methods of manufacture and/or synthesis, products by process,
and intermediates.

○ An issued U.S. patent expiration with 5-year maximum patent term extension - 9/17/2040.

○ An issued U.S. patent expiration without patent term extension - 9/17/2035.

● Multiple
nasal delivery device patent applications concerning the Breath-Powered Nasal Devices and
Uses Thereof haves been filed in the U.S. with the USPTO as utility patent applications.
In addition, multiple nationalized patent applications drawn to the Breath-Powered Nasal
Devices and Uses Thereof have been filed in over 60 countries.

○ Breath-Powered
Nasal Devices and Uses Thereof for, inter alia, treatment of TBI, Including Concussion,
and Methods.

○ Inventions relate to, inter alia, breath-powered nasal devices, single-directional breath-powered nasal devices for providing dual airflow
for propelling a drug substance into a nasal cavity for targeted delivery to the olfactory region in high drug substance concentration
for rapid diffusion into the brain for the treatment of local or systemic and/or central nervous system (“CNS”) injury, disease
or disorder, and methods of treating local or systemic and/or CNS injury, disease or disorder with such devices.

○ An exemplary issued U.S. patent expiration - 10/19/2042.

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The
effect of issued patents is that they provide patent protection for the claims covered by the patents. While the expiration of a product
or method patent may result in a loss of market exclusivity for the covered product or product candidate, commercial benefits may continue
to be derived from later-granted patents on, for example, (i) processes, (ii) methods, (iii) uses, (iv) dosage strengths, (v) dosage
forms, (vi) compositions, (vii) formulations, (viii) treatment regimens, (ix) pharmacokinetic properties, (x) safety properties, (xi)
stability properties, (xii) improvements, (xiii) nasal devices in combination with pharmaceuticals, and (xiv) intermediates related to
the most economical method of manufacture of the active ingredients of such product in the United States and certain other countries.
Market exclusivities may also be available under relevant regulatory law in the United States and certain other countries that can provide
regulatory exclusivities in addition to patent protection. The effect of patent expiration on products or product candidates also depends
upon many other factors such as the nature of the market and the position of the product in it, the growth of the market, the complexities
and economics of the process for manufacture of the active ingredient of the product, the ability to establish bio equivalency, safety
and effectiveness of third parties, and the requirements of new drug provisions of the Federal Food, Drug and Cosmetic Act or similar
laws and regulations in other countries.

We
believe that the protection of discoveries in connection with our development activities, our proprietary products and information,
technologies, processes and know-how and all of our intellectual property are important to our business. There can be no assurance
that our patents, and any patents that may be issued, assigned, or licensed to us in the future, will afford protection against
competitors with similar technology. In addition, no assurances can be given that any patents issued, assigned, or licensed to us
will not be infringed upon or designed around by others or that others may obtain patents that we would require us to license or
design around. If existing or future patents held by third parties and containing broad claims that cover our technology that may
infringe, and if such patents were upheld by a court or other authority of competent jurisdiction as valid and infringed, the
holders of such patents could require us to obtain licenses to use such technology or require us to cease from using such infringing
technology until their infringed patents expire.

Trademarks

Our
trademarks are important to our business. We currently use the following unregistered trademarks: SMaRT Replacement Therapy™, MU1140™,
and LPT3-04™. In November 2025, the USPTO issued a Notice of Allowance in connection with our application for registration of the
mark of ORAGENICS™ for therapeutic products, namely, anti-infectives and vaccine products in the nature of antibiotics for medical
or veterinary use and vaccines for medical or veterinary use. Registration of the mark of ORAGENICS™ is pending, subject to our
filing of a Statement of Use and the subsequent acceptance thereof by the USPTO. Also pending in different classes in the USPTO is our
mark ORAGENICS™ for therapeutic goods, namely, neurotherapeutic products, for medical, pharmaceutical, or veterinary use, namely,
neurosteroid compounds and preparations; Therapeutic goods, namely, neurotherapeutic products, for medical, pharmaceutical, or veterinary
use, namely, nasal devices for medical or pharmaceutical use, namely, nasal devices for delivering drug compounds to the nasal cavity,
sold filled with neurosteroid compounds and preparations; and therapeutic goods, namely, neurotherapeutic products, for medical, pharmaceutical,
or veterinary use, namely, nasal devices for medical or pharmaceutical use, namely, nasal devices for delivering drug compounds to the
nasal cavity, sold empty. We also have rights to use other names essential to our business. Federally registered trademarks have a perpetual
life, as long as they are maintained and renewed on a timely basis and used properly as trademarks, subject to the rights of third parties
to seek cancellation of the trademarks if they claim priority or confusion of usage. We regard our trademarks and other proprietary rights
as valuable assets and believe they have significant value to us.

Protection
of Trade Secrets

We
attempt to protect and safeguard our trade secrets, including the processes, concepts, ideas and documentation associated with our technologies,
through the use of internal policies and confidentiality agreements and non-competition agreements with our current employees and with
other parties to whom we have divulged such trade secrets. There can be no assurance that these agreements will not be breached, that
we will have adequate remedies for any breach, that others will not independently develop equivalent proprietary information or that
other third parties will not otherwise gain access to our trade secrets and other intellectual property. If our employees or other parties
breach our confidentiality agreements and non-competition agreements or if these agreements are not sufficient to protect our technology
or are found to be unenforceable, our competitors could acquire and use information that we consider to be our trade secrets and we may
not be able to compete effectively. Most of our competitors have substantially greater financial, marketing, technical and manufacturing
resources than we have and we may not be profitable if our competitors are also able to take advantage of our trade secrets.

Human
Capital

Employees

As
of December 31, 2025, we had three full-time and part-time employees. We believe our relations with our employees are good.
None of our employees are represented by a labor union, and we are not a party to any collective bargaining agreement.

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Consultants

We
have consulting agreements with a number of scientists, clinicians, and regulatory experts who support our research and development and
regulatory activities. These consultants provide expertise in areas including neurology, clinical development, manufacturing, and regulatory
affairs.

We
retain consultants pursuant to written consulting agreements under which we pay consulting fees and reimburse out-of-pocket expenses
incurred in performing services for us. In addition, certain consultants have been granted options to purchase shares of our common
stock pursuant to separate equity award agreements, subject to applicable vesting requirements. Our consultants may be employed by other
entities or provide services to other companies and, as a result, may have commitments that could limit their availability to us.

Corporate
Information

We
were incorporated in November 1996 and commenced operations in 1999. We consummated our initial public offering in June 2003. Our Corporate
office is located at 9015 Town Center Parkway, Suite 143, Lakewood Ranch, Florida 34202.

Available
Information

Our
website is www.oragenics.com. On our website we make available at no cost our annual reports on Form 10-K, quarterly reports on Form
10-Q, current reports on Form 8K and amendments to those reports filed or furnished as soon as reasonably practicable after we electronically
file such material with, or furnish them to, the United States Securities and Exchange Commission (“SEC”). The information
contained on our website or connected thereto is not a part of, or incorporated into, this annual report on Form 10-K.