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We have engaged in ongoing
regulatory interactions with the FDA, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), and the European
Medicines Agency (EMA) regarding the clinical and biomarker data for OST-HER2 in recurrent, fully resected pulmonary metastatic Osteosarcoma.
Following submission of the Non-Clinical and Chemistry, Manufacturing & Controls (CMC) modules of our Biologics License Application
(BLA) to the FDA at the end of January 2026, we anticipate submitting the clinical BLA module following an expected Type B meeting with
the FDA in the second quarter of 2026 and completing conditional Marketing Authorization Application (MAA) submissions to both the MHRA
and the EMA in the second quarter of 2026. We also anticipate releasing additional biomarker data in the second quarter of 2026 to further
characterize immune pathway activation and its relationship to clinical outcomes. We expect to initiate confirmatory clinical studies
in the third quarter of 2026 in support of conditional approval pathways. If OST-HER2 receives approval under the FDA’s Accelerated
Approval Program prior to September 30, 2029, we would become eligible to receive a Priority Review Voucher under the Rare Pediatric Disease
Designation Program.

Upon success in gaining regulatory
approval from the FDA with OST-HER2 in Osteosarcoma, we intend to evaluate OST-HER2’s potential use, both alone and in combination
with HER2 targeting antibodies such as Herceptin®, in other solid tumors including breast, esophageal and lung cancers. OST-HER2 has
potential uses in both the prevention of metastases in solid tumors, and therapeutically against HER2-expressing solid tumors treated
with HER targeting antibodies.

We also own rights to an OST-Tunable
Drug Conjugate (OST-tADC) platform, a next generation antibody-drug conjugate (ADC) silicone dioxide linker technology. “Tunable”
is a term used in drug development that refers to the properties that can be influenced by chemical modifications, and “antibody-drug
conjugate” or ADC is a term used to describe a drug made up of a monoclonal antibody attached to a cytotoxic payload, or a highly
active and toxic pharmaceutical molecule, through chemical linkers. The ADC links an antibody that can home in on a targeted tumor to
deploy the cytotoxic payload or toxic agent against the tumor. Furthering our founding mission, we intend to investigate clinical indications
for OST-tADC in Osteosarcoma and other solid tumors.

Pipeline of Our Product Candidates

We have built a pipeline of
product candidates targeting multiple indications for solid cancers. Our pipeline includes two drug technologies: (i) OST-HER2, an
off-the-shelf immunotherapy, which is a type of cancer treatment that helps one’s immune system fight cancer, comprised of a genetically
weakened and modified strain of Listeria monocytogenes, a species of bacteria that causes the infection listeriosis, that expresses
HER2 peptides, and (ii) OST-tADC, a next generation tunable ADC with a plug-and-play platform that features tunable pH sensitive
silicone linkers (SiLinkers™). The payloads may include antibodies, chemotherapeutics, cytotoxins and potentially mRNA treatments
directly into and in the vicinity of solid tumors.

OST-HER2 (OST31-164). Our
most advanced product candidate, OST-HER2, is a genetically engineered strain of Listeria monocytogenes, attenuated for reduced
virulence, increased antibiotic susceptibility and the expression of three HER2 protein epitopes fused to immune-enhancing peptides on
the membrane of the bacteria.

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OST-HER2 has received an orphan
drug designation in the United States. The FDA may designate a biologic product as an orphan product if it is intended to treat a
rare disease or condition, which generally is defined as having a patient population of fewer than 200,000 individuals in the United States.
Osteosarcoma has an incidence rate of approximately 1,000 individuals affected per year in the United States. Orphan product designation,
subject to limited exceptions, can provide a period of market exclusivity for a product that is the first to receive marketing approval
for the designated indication. Other potential indications may include breast, esophageal, lung and other solid tumors. In August 2021,
OST-HER2 was awarded rare pediatric disease designation and previously received fast track designation by the FDA. Such designations
by the FDA do not convey any advantages in, or shorten the duration of, the regulatory review or approval process.

OST-tADC. Our
tunable drug conjugate (tADC) platform is currently in preclinical development. Each tADC contains four main components: ligand, payload
cassette adaptor, linker and payload. In addition, tADCs contain units to optimize physicochemical properties. The ligands are selected
to bind to receptors overexpressed on cancer cells. Upon binding, the tADC construct gets internalized into the cancer cell, where the
payload is released, to cause cell death. The payload cassette adapters enable the stoichiometrical attachments of linkers and payloads.
The SiLinkers represent a novel and pH-sensitive linker system. The SiLinker release profile can be tuned with proximal functional groups,
resulting in payload release in the endosome, lysosome or the slightly acidic tumor microenvironment. The SiLinker system is compatible
with a variety of payloads and not limited to the employment of cytotoxic drug delivery. The first set of internal programs focus on the
use of SiLinker and conditionally active payloads (CAPs™) drug products. CAPs are cytotoxic drugs which on their own, due to their
functional groups, cannot readily permeate cells at physiological pH; however, at the slightly acidic pH of the tumor-microenvironment,
after some linker cleavage, these payloads readily permeate into cancer cells, resulting in an enhanced bystander effect. Our lead program
targets folate receptor alpha, a protein expressed on the surface of cells that participates in cell signaling, as well as cellular replication
and division, and is overexpressed in multiple cancers such as ovarian and endometrial cancers. The lead compound employs folic acid,
a small molecule, as the targeting ligands and contains six exatecan-silanols, which is a type of silanol-based cytotoxic payload. This
discovery work is being carried out at Syngene International Limited, an integrated contract research organization (CRO) based in Bangalore,
India.

From time to time, we may
evaluate collaboration opportunities for our product candidates. We expect to work opportunistically with pharmaceutical and biotechnology
companies, as we have done with BlinkBio, Inc. by in-licensing the OST-tADC technology, seeking to utilize our technology and know-how
for developing additional oncologic drug products. The following table summarizes information regarding our product candidates and development
programs.

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In addition to our development
of OST-HER2 for multiple indications of solid cancers in humans, OST-HER2 is a product candidate for veterinary use in canines. As part
of our growth strategies, we intend to consider potentially out-licensing OST-HER2 to animal health companies for such use. See “OS-Focused
Clinical Trials and Studies — Preclinical Animal Study” for more information.

Our Acquisition of HER2 and Lm-Related
Assets

On April 9, 2025, pursuant
to the terms of an Asset Purchase Agreement, dated as of January 28, 2025 (the “HER2 Purchase Agreement”), between us and
Ayala Pharmaceuticals, Inc. (formerly known as Advaxis, Inc. (“Ayala”)), we completed the acquisition of the Lm-based
immune-oncology programs and related intellectual property assets (the “HER2 Assets”) from Ayala. The HER2 Assets include
two investigational new drug applications (“IND”) with the FDA: (i) ADXS-503 for non-small cell lung cancer; and (ii) ADXS-504
for prostate cancer.

Our OS-Focused Clinical Trials and Studies

We and our former licensors
have conducted a number of clinical trials and studies in the field of Osteosarcoma and Tunable Drug Conjugates to date.

Phase IIb Clinical
Trial. In July 2021, we initiated a Phase IIb clinical trial to evaluate the safety and efficacy of our OST-HER2 product candidate
in patients following complete surgical resection of recurrent pulmonary metastatic Osteosarcoma. The study was sponsored by us and conducted
by George Clinical, Inc. A total of 41 eligible patients between the ages of 12 and 39 were enrolled, with full enrollment completed in
October 2023. Patients received a total of 16 intravenous infusions of OST-HER2 administered over a 48-week treatment period. The trial
was conducted at major hospitals across 21 clinical sites in 18 U.S. states. The treatment phase has been completed, and patients continue
to be followed prospectively for long-term survival.

The primary endpoint of the
study was 12-month event-free survival (“EFS”), defined as the proportion of patients who remained recurrence-free at 12 months
following surgical resection. EFS outcomes were compared to a best available historical control derived from published U.S. literature
(the “Published Control”), with recurrence assessments conducted every three months in accordance with standard of care. In
the first quarter of 2025, we announced that the study met its primary endpoint with statistical significance. Specifically, 33% of OST-HER2-treated
patients (n=41) were event-free at 12 months compared to 20% in the Published Control population, representing a 13-percentage point absolute
improvement over historical outcomes.

Secondary endpoints included
overall survival and safety. In October 2025, we announced final two-year overall survival data. Among 36 evaluable patients, 75% (27
of 36) were alive two years following their most recent pulmonary resection compared to 40% in the Published Control population (p <
0.0001). Earlier interim analyses demonstrated 12-month overall survival of 91% for OST-HER2-treated patients compared to 80% in the Published
Control, and 24-month overall survival of 61% compared to 40%, respectively. Survival assessments were conducted at three-month intervals.
The study was not powered as a randomized controlled trial, and comparisons were made against published historical data rather than a
contemporaneous control arm.

Safety was assessed throughout
the treatment period and follow-up using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE). OST-HER2
was generally well tolerated. No treatment-emergent adverse events classified as CTCAE Grade 5 (death) were reported. Adverse events were
monitored during the 48-week treatment period, with ongoing follow-up for survival and long-term safety.

In January 2026, we announced
results from exploratory biomarker analyses evaluating immune activation markers in peripheral blood. Activation of biomarkers within
the interferon gamma pathway was observed to correlate with overall survival outcomes and distinguished long-term survivors (≥ two
years) from short-term survivors (< one year). These biomarker analyses were exploratory in nature, were not pre-specified as primary
or secondary endpoints, and have not been validated as surrogate endpoints for clinical benefit.

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Although the Phase IIb trial
met its primary endpoint and demonstrated favorable overall survival outcomes relative to historical controls, the study was conducted
as an open-label trial and did not include a randomized, contemporaneous control arm. Comparisons to historical controls are subject to
inherent limitations, including potential differences in patient populations, standards of care, supportive therapies and assessment methodologies,
and such comparisons may not be predictive of results in a randomized controlled trial. We intend to continue engaging with the FDA regarding
potential regulatory pathways for OST-HER2. However, there can be no assurance that the FDA will determine that the results of the Phase
IIb trial are sufficient to support submission or approval of a BLA. The FDA may require additional clinical data, including data from
a randomized Phase III clinical trial, prior to approval. The necessity, scope and design of any additional trials will depend on future
regulatory interactions and formal FDA determinations.

Phase Ib Clinical
Trial. From September 2015 through May 2017, Advaxis, Inc. (“Advaxis”) sponsored and conducted a Phase Ib clinical
trial evaluating ADXS-HER2 (also known as ADXS31-164), the intellectual property rights to which we subsequently acquired from Ayala for
further development and commercialization as our OST-HER2 product candidate. The Phase Ib study was a multicenter, open-label, dose-escalation
trial designed to evaluate safety and tolerability, determine the maximum tolerated dose (“MTD”), and establish a recommended
Phase II dose. The study enrolled 12 adult patients with advanced, HER2-expressing solid tumors. Patients received escalating intravenous
doses of ADXS-HER2 administered every three weeks during a 12-week treatment cycle. Clinical sites were located at hospitals in Colorado,
Michigan, North Carolina, Pennsylvania and Texas. Following completion of study treatment, all 12 patients entered a three-year surveillance
period to monitor for potential Listeria monocytogenes-related complications.

The primary endpoints were
safety and tolerability, including the incidence of dose-limiting toxicities (“DLTs”) during the first four months of treatment
and the frequency and severity of adverse events, assessed using the CTCAE, including Grade 4 events (life-threatening consequences).
Secondary endpoints included (i) objective tumor response rate (complete or partial response) as assessed by Response Evaluation Criteria
in Solid Tumors (RECIST) v1.1 and immune-related RECIST (ir-RECIST), and (ii) immunologic response parameters measured through serial
peripheral blood collection and analysis of peripheral blood mononuclear cells and serum biomarkers.

No dose-limiting toxicities
were observed at the highest dose level evaluated (1 × 109 colony-forming units (“CFU”)), and no maximum
tolerated dose was reached. ADXS-HER2 administered intravenously at 1 × 109 CFU appeared to be generally well tolerated
in the 12 treated and evaluable subjects. No objective tumor responses (complete or partial responses) were observed in this late-stage,
heavily pre-treated patient population. Based on the observed safety and tolerability profile, 1 × 109 CFU was selected
as the recommended Phase II dose.

This Phase Ib study was primarily
designed to assess safety and dose selection and was not powered or intended to evaluate clinical efficacy. Accordingly, the absence of
objective tumor responses in this small, heterogeneous patient population should be interpreted in the context of the study’s dose-escalation
design and safety-focused objectives.

Preclinical Animal Study.
From July 2012 through September 2015, a prior licensee of Advaxis sponsored and conducted a preclinical study evaluating ADXS-HER2
in 18 companion canines with HER2-positive appendicular Osteosarcoma following standard-of-care treatment (amputation and chemotherapy).
This study is sometimes referred to as a Phase I veterinary clinical study. We subsequently acquired the intellectual property rights
to ADXS-HER2 constructs for further development and commercialization as OST-HER2.

Canine appendicular Osteosarcoma
is recognized in scientific literature as a spontaneous large-animal model with biological and clinical similarities to pediatric Osteosarcoma.
In this study, ADXS-HER2 was administered in the setting of minimal residual disease following definitive surgical and chemotherapeutic
management. Outcomes were compared to a historical control cohort treated with amputation and chemotherapy alone.

Results published in 2016
in Clinical Cancer Research (Mason, N. et al., “Immunotherapy with a HER2-Targeting Listeria Induces HER2-Specific Immunity and
Demonstrates Potential Therapeutic Effects in a Phase I Trial in Canine Osteosarcoma”) reported improvements in overall survival
and metastatic disease progression relative to the historical control group. Reported overall survival rates at one, two and three years
were 77.8%, 67% and 56%, respectively, for ADXS-HER2-treated dogs, compared to 55%, 28% and 22%, respectively, for historical controls.
Median survival time was 956 days in the ADXS-HER2-treated group compared to 423 days in the historical control group (hazard ratio 0.33;
95% confidence interval 0.136–0.802; p = 0.014). A reduction in the incidence of metastatic disease was also reported relative to
historical controls. The study also noted the important translational relevance of the findings for children with Osteosarcoma. This study
for canine Osteosarcoma indications constituted preclinical work as it relates to our development of OST-HER2 to treat Osteosarcoma in
humans. These findings were generated in a small, non-randomized veterinary study using historical controls. Animal study results are
not necessarily predictive of clinical outcomes in humans.

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Following completion of the
study, an application for conditional licensure of ADXS-HER2 for the treatment of canine Osteosarcoma was submitted to the United States
Department of Agriculture (“USDA”). In December 2017, ADXS-HER2 was granted a conditional license for veterinary use in dogs
one year of age and older diagnosed with Osteosarcoma. As the current owner of the ADXS-HER2 constructs, we held the conditional license
for OST-HER2. The conditional license permitted limited commercial distribution while additional data was to be generated to support full
licensure. We subsequently allowed the conditional license to lapse in connection with manufacturing process improvements and a strategic
reassessment of our development priorities. We may seek a new conditional license in the future following engagement with a USDA-licensed
contract manufacturer. Full USDA licensure would require submission of additional data, including studies addressing safety, purity, potency,
effectiveness, metabolism and shedding in canines. We are currently evaluating potential future development strategies with respect to
the veterinary indication. There can be no assurance that we will seek or obtain future USDA licensure.

Preclinical Development.
Our OST-HER2 product candidate is also being evaluated for potential development in additional HER2-expressing solid tumor indications,
including breast, esophageal and lung cancers. These programs are currently in the preclinical stage. The scope of additional preclinical
development required, if any, will depend on multiple factors, including the totality of available clinical and nonclinical data, the
specific tumor indication pursued, the design of any subsequent clinical protocol (including whether additional cohorts are incorporated
into a follow-on or master protocol) and feedback from the FDA and other regulatory authorities. While OST-HER2 has been evaluated clinically
in Osteosarcoma, regulatory authorities may require additional preclinical pharmacology, toxicology, biodistribution or other nonclinical
studies to support initiation of clinical trials in different tumor types. The extent of any such requirements will depend on regulatory
determinations regarding the sufficiency and applicability of existing data to the proposed indications. There can be no assurance that
additional preclinical studies will not be required prior to initiating clinical trials in breast, esophageal, lung or other solid tumor
indications, or that existing clinical data will be deemed sufficient to support expansion into those indications.

Our OST-tADC product candidate
for all indications is also currently in preclinical development. We will need to conduct further preclinical trials for OST-tADC prior
to the submission of an IND in order to pursue clinical trials with these candidates. Such preclinical trials are expected to include
pharmacokinetics and pharmacodynamics, two-week dose finding toxicology studies in vivo (on living cell lines or in living animals), as
well as good laboratory practice (GLP) trials ensuring stability, potency and purity of the IND product candidate.

Our Technology Platform

We are in the process of building
a fully integrated platform technology to accelerate the development of a range of product candidates across multiple therapeutic areas.
Our platform technology is intended to leverage our management’s in-depth experience in immunotherapy research, development and
manufacturing to enable us to pursue multiple therapeutic targets. Our scientists and scientific advisors have accumulated decades of
collective experience in the field of immunotherapy, oncology and small-molecule drug production, contributing key insights and significant
achievement in our clinical development process.

Our Growth Strategies

Our goal is to enrich and
lengthen the lives of patients by being a leading, fully integrated biotechnology company. We are seeking to develop, manufacture and
commercialize multiple product candidates targeting orphan and non-orphan oncologic diseases across multiple tissue types and therapeutic
areas. To achieve our goal, we are pursuing the following growth strategies:

●
We may consider out-licensing OST-HER2 to animal health companies for veterinary use in dogs diagnosed with Osteosarcoma, one year of age or older, consistent with prior conditional licensure and preclinical data.

●
Obtain marketing approval for OST-HER2 in Osteosarcoma, then quickly pivot to a master protocol within breast, esophageal, lung and other solid tumors where metastases express HER2 that could be targeted by immune cells.

●
Complete pre-clinical and toxicology trials with the lead drug candidate for OST-tADC (OST-tADC-A, Exatecan-silanol-FRa) and submit an IND to initiate a Phase I trial in ovarian cancer and other folate receptor alpha-overexpressing tumors, including endometrial cancer and certain Osteosarcomas. We believe that positive results from preclinical and GLP toxicology studies may also facilitate potential out-licensing opportunities for SiLinker and CAPs drug products, without limiting therapeutic development.

●
Establish global commercial, clinical and medical affairs infrastructure to support the potential launch and commercialization of OST-HER2-based therapies and related product candidates.

Through these strategies,
we aim to leverage our OST-HER2 and OST-tADC platforms to develop a diversified oncology pipeline across multiple tumor types, while maintaining
flexibility to pursue both human and veterinary indications, and to capture value through partnerships, out-licensing and clinical expansion.

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Expansion Opportunities

We may seek to expand our
business through acquisitions, in-licensing of complementary products or technologies, or the acquisition of companies with complementary
capabilities. While we have current collaborative agreements in place, we believe in an opportunistic approach to collaboration and licensing;
thus, we expect to operate in a manner that is customary in the pharmaceutical industry, including potential acquisitions and partnerships.

We believe there is continued
interest from larger pharmaceutical companies in biotechnology firms developing next-generation therapies, including ADCs, due in part
to the potential of these therapies to address unmet medical needs in oncology. Advances in ADC technology, including combinations with
immunotherapies and other targeted agents, have broadened the potential applications for these modalities, which we may consider as part
of our expansion strategy.

Our Scientific Collaborations

Scientific Collaborators.
We collaborate with experts and physicians to help advance our programs and, together, we are focused on translational strategies
to support the clinical study of our new therapy candidates. These collaborations support our goals to translate deep expertise in structure-based
drug design into a novel portfolio of precisely targeted therapies. We strive to address medical needs for patients with cancer harboring
resistance mutations in driver kinases using technology originally developed at the University of Pennsylvania under the guidance of Dr. Robert
G. Petit, our Chief Medical and Scientific Officer. Our partnering approach with physician-scientists allows us to understand the
limitations of existing therapies, which we believe will lead to product candidates that address the dual needs of treatment resistance
and kinase selectivity. OST-HER2’s compositions and methods of use are covered by two granted U.S. utility patents and one
granted Japanese patent. These patents were originally developed at the University of Pennsylvania and were owned either solely by the
University or jointly with Advaxis. We acquired all rights, title and interest in these patents from Advaxis pursuant to an assignment,
which enables us to develop, manufacture and commercialize OST-HER2 without reliance on in-licensing from Advaxis. See “Our Licensing
Obligations — Advaxis” and “Our Intellectual Property” below.

We have also established collaborations
through service agreements with global CROs to provide scale and expertise in research chemistry, chemical manufacturing, biology, pharmacology
and toxicology, and clinical studies.

Scientific Advisory
Board. We have established a scientific advisory board comprised of six members with extensive experience in the field of oncology.
Our scientific advisors include researchers who publish widely cited research on topics relevant to the study and treatment of cancer,
lead clinical units at experienced precision medicine cancer centers in the United States and are actively involved in our drug development
process and programs. Our scientific advisory board meets periodically with our board of directors and management to discuss matters relating
to our business activities and to establish commercial business alliances. Members of our scientific advisory board are reimbursed by
us for out-of-pocket expenses incurred in connection with serving on our advisory board.

Our scientific advisory board
currently includes the following physicians and their professional affiliations:

● Nabil M. Ahmed, MD — Texas
Children’s Hospital

●
Peter M. Anderson, MD — Cleveland Clinic

●
Meenakshi Hedge, MD — Texas Children’s Hospital

●
Alejandro Sweet-Cordero, MD — University of California San Francisco

●
Brenda Weigel, MD — Masonic Cancer Center — University of Minnesota

●
Felasfa M. Wodajo, MD — Inova Fairfax Hospital, Virginia

Patient Advocacy Advisory
Board. We have established a patient advocacy advisory board comprised of four members with experience dealing with the effects
of Osteosarcoma. This board is responsible for reviewing and establishing our patient advocacy philosophy and policy. This board also
develops procedures for patient care evaluation while adhering to regulatory standards. This board identifies gaps in patient care and
represents patient interests at FDA meetings, ensuring that patient voices are heard in regulatory discussions. Members of our patient
advocacy advisory board are reimbursed by us for out-of-pocket expenses incurred in connection with serving on such board and sign customary
non-disclosure agreements.

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Our patient advocacy advisory
board currently includes the following individuals and their affiliations:

●
Miriam Cohen — Founding Member, Chairperson and President of Osteosarcoma Collaborative

●
Olivia Egge — Founding Member, Counsel and Patient Advocate of Osteosarcoma Collaborative; MD candidate at David Geffen School of Medicine at UCLA; Osteosarcoma Survivor

●
Mac Tichenor — President of Osteosarcoma Institute

●
Tony Trent — President of The Tyler Trent Foundation

●
Serena Subada — OST-HER2 Trial Participant

ADC Advisory Board.
We have established an ADC advisory board comprised of two members with extensive experience with ADC technologies. This board
is responsible for reviewing and establishing our strategy and policies related to ADCs and helps to design and implement procedures for
evaluating the efficacy and safety of our ADC technologies, ensuring compliance with regulatory standards. This board identifies opportunities
to enhance ADC technology and address challenges in development, contributing to the advancement of innovative therapies in the field.
Members of our ADC advisory board are reimbursed by us for out-of-pocket expenses incurred in connection with serving on such board and
sign customary non-disclosure agreements.

Our ADC advisory board currently
includes the following professionals and their affiliations:

● Borys Shor, Ph.D. — President
and Chief Executive Officer of Manhattan BioSolutions, Inc.

● Jutta Wanner, Ph.D. — Senior
Vice President of Drug Discovery at Alpha-9 Oncology, Inc.

● Colin Goddard, Ph.D. — Chairman
at BlinkBio, Inc.

Some of the members of our
advisory boards may serve as consultants under consulting agreements for which they will receive compensation. To date, however, none
of our advisory board members has served as consultants to us, and we have not entered into any consulting agreements with any of them.
To our knowledge, none of our advisory board members has any conflict of interest between their obligations to us and their obligations
to others. Hospitals, medical centers and companies with which advisory board members are involved may in the future have commercial relationships
with us.

Our Licensing Obligations

Advaxis. In
November 2020, we entered into an amended and restated development, license and supply agreement with Advaxis, pursuant to which
Advaxis granted a license to us that allowed us to utilize Advaxis’ ADXS-HER2 construct patents to develop and commercialize ADXS-HER2,
our lead product candidate (OST-HER2). On April 9, 2025, we acquired from Ayala (formerly Advaxis) the HER2 Assets. In connection with
such acquisition, the amended and restated development, license and supply agreement was terminated.

BlinkBio. In
August 2020, we entered into a licensing agreement with BlinkBio, Inc., pursuant to which BlinkBio granted a license to us that allows
us to utilize BlinkBio’s proprietary technology to develop, manufacture and commercialize certain of our products. BlinkBio granted
us an exclusive license for tADC’s that are directed towards, binds to or modifies the folate receptor alpha and a co-exclusive
license for tADC’s that are directed towards, binds to or modifies any target other than the folate receptor alpha, such as HER2.
In connection with the license agreement, we also agreed to issue a convertible note to BlinkBio.

Biolacuna
Ltd. We have contracted with Biolacuna Ltd, a global life sciences advisory firm, to assist with the following agencies requirements
to register OST-HER2 and gain approval of its use in the respective regions:

● European Medicines Agency (EMA, Europe);

● Medicines Evaluation Board (MEB, Netherlands);

● Medicines and Healthcare products Regulatory Agency (MHRA,
United Kingdom); and

● U.S. Food and Drug Administration (FDA, United States).

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University of Pennsylvania.
On April 9, 2025, we acquired from Ayala the HER2 Assets. Pursuant to the terms of the HER2 Purchase Agreement, the amended and restated
development, license and supply agreement with Advaxis terminated. In connection with the acquisition of the HER2 Assets, we were assigned
by Ayala a license agreement with the Trustees of the University of Pennsylvania covering the use of HER2 construct patents. Under the
terms of the license agreement, we are required to pay an annual license fee to the Trustees of the University of Pennsylvania. We are
obligated to pay a royalty equal to 1.5% of net sales related to:

● OST-HER2-related sales;

● ADXS-503-related sales;

● ADXS-504-related sales; and

● Sales related to any new immunotherapy drug candidates created from the Lm platform during the
term of such licensing agreement.

See “Management’s
Discussion and Analysis of Financial Condition and Results of Operations” for more information on our licensing obligations
and the BlinkBio convertible note.

Our Intellectual Property

Our commercial success depends
in part on our ability and the ability of those third parties from whom we in-license patents to obtain and maintain intellectual property
protection in the United States and other countries for our current or future product candidates, including our lead core product
candidate OST-HER2, our other core product candidate OST-tADC, our non-core product candidates, our proprietary compound library and other
know-how. We seek to protect our proprietary and intellectual property position by, among other methods, in-licensing, owning, co-owning
and filing patents and patent applications in the United States and abroad related to our proprietary technology, inventions and
improvements that are important to the development and implementation of our business. We also rely on trade secrets, know-how and continuing
technological innovation to develop and maintain our proprietary and intellectual property position.

Following our acquisition
of the HER2 Assets from Ayala, we now own or co-own certain patents covering our lead product candidates. We also in-license patents
and patent applications for our other core candidate, OST-tADC, from BlinkBio, Inc. We co-own with the University of Pennsylvania the
intellectual property related to OST-HER2, which includes two granted U.S. utility patents, one granted Japanese patent, and two additional
foreign patents and pending applications, with expected expiration between 2029 and 2035, excluding any potential patent term extensions.
We hold exclusive rights to patents and patent applications covering the commercial manufacturing of OST-HER2 and our broader Listeria-based
immunotherapy platform, including two granted U.S. utility patents, one pending U.S. patent application, 11 granted foreign patents and
12 pending foreign applications. These patents are expected to expire in 2038, with one U.S. patent expiring in 2040 after patent term
adjustment. The intellectual property licensed from BlinkBio, Inc. includes six granted U.S. utility patents and multiple foreign patents
and pending applications covering methods of use for silicon-based drug conjugates and silanol-based therapeutic payloads, with expected
expiration between 2036 and 2037, excluding any potential patent term extensions.

We also rely on trade secrets
and know-how relating to our proprietary technology and product candidates and continuing innovation to develop, strengthen and maintain
our proprietary position in the field of oncology. Our future plans also include reliance on data exclusivity, market exclusivity and
patent term extensions when available.

The degree of patent protection
we require to successfully commercialize our current or future product candidates may be unavailable or severely limited in some cases
and may not adequately protect our rights or permit us to gain or keep any competitive advantage. We cannot provide any assurances that
any of the patents that we own, co-own or in-license have, or that any of such pending patent applications that mature into issued patents
will include, claims with a scope sufficient to protect OST-HER2 and OST-tADC or our other current or future product candidates.
In addition, if the breadth or strength of protection provided by such patent applications or any patents we may own, co-own or in-license is
threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.

Our ability to stop third
parties from making, using, selling, offering to sell or importing products identical or similar to ours will depend on the extent to
which we have rights under valid and enforceable patents, trade secrets or other intellectual property rights that cover these activities.
The patent rights of biotechnology and pharmaceutical companies like ours are generally uncertain and can involve complex legal, scientific
and factual issues. Our and any future licensor’s current and future patent applications may not result in the issuance of any patent
in any particular jurisdiction, and the claims of any current or future issued patents, even if those claims are valid and enforceable,
may not provide sufficient protection from competitors. Any owned or in-licensed patent rights we may obtain may not enable us to prevent
others from replicating, manufacturing, using or administering our product candidates for any indication. Moreover, the coverage initially
claimed in a patent application may be significantly reduced before a patent is issued, and a patent’s scope can be reinterpreted
after issuance. In addition, any patent we may own, co-own or in-license may be challenged, circumvented or invalidated by third parties.
As a result, we cannot ensure that any of our product candidates will be protected by valid and enforceable patents. See “Risk
Factors — Risks Related to Our Intellectual Property” for a more comprehensive description of risks related
to our intellectual property.

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Our Commercialization Strategy

We intend to retain significant
development and commercial rights to our product candidates and, if marketing approval is obtained, to commercialize our product candidates
on our own, or potentially with a partner, in the United States and other regions. We currently have no sales, marketing or commercial
product distribution capabilities. We intend to build the necessary infrastructure and capabilities over time for the United States,
and potentially other regions, following further advancement of our product candidates. We believe that such a focused sales and marketing
organization will be able to address the community of oncologists who are the key specialists in treating the patient populations for
which our product candidates are being developed. Clinical data, the size of the addressable patient population and the size of the commercial
infrastructure and manufacturing needs may all influence or alter our commercialization plans. The responsibilities of the marketing organization
would include developing educational initiatives with respect to approved products and establishing relationships with researchers and
practitioners in relevant fields of medicine.

Our Future Manufacturing

We do not own or operate,
and currently have no plans to establish, any manufacturing facilities. We rely, and expect to continue to rely, on third parties for
the manufacture of our product candidates for pre-clinical and clinical testing, as well as for commercial manufacturing if any of our
product candidates obtain marketing approval. We also rely, and expect to continue to rely, on third parties to package, label, store
and distribute our investigational product candidates, as well as our commercial products if marketing approval is obtained.

We believe that this strategy
allows us to maintain a more efficient infrastructure by eliminating the need for us to invest in our own manufacturing facilities, equipment,
and personnel while also enabling us to focus our expertise and resources on the development of our product candidates.

All of our product candidates
are biopharmaceuticals and are manufactured in synthetic processes from available starting materials. The chemistry appears amenable to
scale-up and does not currently require unusual equipment in the manufacturing process. We expect to continue to develop product candidates
that can be produced cost-effectively at contract manufacturing facilities.

Currently, the OST-HER2 active
pharmaceutical ingredients (API) (e.g., clinical drug substance) are manufactured in accordance with GMPs. The drug product formulation
is being developed with the goal of producing lyophilized therapeutics with consistent and immediate release dissolution profiles that
can be reproducibly manufactured using automated equipment. All manufacturing activities for the OST-HER2 drug product are performed in
accordance with GMPs. We currently rely on these vendors as single-source contract manufacturing organizations.

We are in the process of developing
our supply chain for each of our product candidates and intend to put in place framework agreements under which third party ReciBioPharma,
a chemical manufacturer, will generally provide us with necessary quantities of API and drug product on a project-by-project basis based
on our development needs.

As we advance our product
candidates through development, we will explore adding backup suppliers for the OST-tADC and drug product for each of our product candidates
to protect against any potential supply disruptions.

We generally expect to rely
on third parties for the manufacture of any companion diagnostics that we may develop.

Government Regulation

Our current or future product
candidates and the activities associated with their development and commercialization, including their design, testing, manufacture, safety,
efficacy, recordkeeping, labeling, storage, approval, advertising, promotion, sale, distribution, import and export are subject to comprehensive
regulation by the FDA and other regulatory agencies in the United States and by comparable authorities in other countries.

Preclinical Studies and IND

Before initiating clinical
trials in humans, a sponsor must complete preclinical development activities, which generally include laboratory evaluations of product
chemistry, manufacturing, formulation and stability, as well as in vitro and animal studies designed to assess pharmacology, toxicology
and potential safety risks. Nonclinical safety studies intended to support an IND application are required to comply with applicable GLP
regulations.

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To initiate human clinical trials in
the United States, a sponsor must submit an IND to the FDA. An IND contains, among other things, results of preclinical studies, manufacturing
and analytical data, any available clinical data or relevant literature, and a proposed clinical trial protocol. The IND submission process
is intended to allow the FDA to assess whether the investigational product is reasonably safe to evaluate in humans and whether the proposed
clinical trial protocol is appropriate.

An IND becomes effective 30
days after receipt by the FDA unless the FDA, within that 30-day period, places the proposed clinical trial on full or partial clinical
hold due to safety concerns or deficiencies in the submission. If a clinical hold is imposed, the sponsor must address the FDA’s
concerns to the agency’s satisfaction before the clinical trial may proceed. Accordingly, submission of an IND does not guarantee
that the FDA will permit a clinical trial to begin. Certain long-term nonclinical studies, such as reproductive toxicity or carcinogenicity
studies, may continue after an IND becomes effective.

Clinical Trials

Clinical trials must be conducted
in accordance with applicable federal statutes and regulations governing drug development and human subject research, as well as in compliance
with Good Clinical Practice (“GCP”) requirements, which are international ethical and scientific quality standards intended
to protect the rights, safety and welfare of human subjects and to ensure the integrity and reliability of clinical trial data. Clinical
trials must also be conducted pursuant to protocols that detail, among other things, the study objectives, inclusion and exclusion criteria,
dosing regimen, safety monitoring procedures, and statistical analysis plans designed to evaluate efficacy and safety endpoints.

Clinical trials are typically
conducted at multiple geographically dispersed sites to support generalizability of the data and to enable the FDA to evaluate the overall
benefit-risk profile of the investigational product and determine whether it satisfies the applicable statutory standard for approval.
Clinical data generated in these trials form the basis for the product labeling, if approved.

In the United States, each
clinical trial must be reviewed and approved by an Institutional Review Board (“IRB”) prior to initiation. An IRB is a duly
constituted body established to review and monitor biomedical research involving human subjects and has authority to approve, require
modifications to, or disapprove research in order to protect the rights and welfare of trial participants. In foreign jurisdictions, clinical
trials are subject to review and approval by independent ethics committees or similar regulatory authorities in accordance with applicable
local laws and regulations.

The FDA may impose a clinical
hold at any time before or during a clinical trial if it identifies safety concerns or determines that the investigation is not being
conducted in accordance with applicable statutory or regulatory requirements. A clinical hold may delay or suspend a trial until the identified
deficiencies are satisfactorily addressed. Similarly, an IRB may suspend or terminate a trial at its institution for non-compliance with
applicable legal or regulatory requirements or IRB determinations, or if it determines that the research presents an unexpected serious
risk to subjects.

Investigational products used
in clinical trials must be manufactured in accordance with applicable current good manufacturing practice (“cGMP”) requirements
under federal law and related regulations. While full commercial-scale validation is not required during early development, manufacturing
controls must be sufficient to ensure product identity, strength, quality and purity appropriate for the stage of development. As clinical
development progresses, regulatory expectations for manufacturing controls and validation generally increase.

Marketing Approval

Before we can commercialize
any of our current or future product candidates, we must obtain marketing approval from the applicable regulatory authorities. We have
not received approval to market any of our current product candidates. We expect to rely on third-party contract research organizations
and regulatory consultants to assist us in preparing and submitting marketing applications and navigating the regulatory review process.
Securing regulatory approval requires the submission of extensive preclinical and clinical data, as well as supporting information, to
the relevant regulatory authorities for each therapeutic indication and line of treatment to establish the product candidate’s safety,
efficacy, and, in the case of biologics, purity and potency. Securing regulatory approval also requires the submission of detailed information
regarding the drug manufacturing process and, in most cases, inspection of manufacturing facilities by the applicable regulatory authority.

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The process required by the FDA before
a drug or biologic product may be marketed in the United States generally involves the following:

●
completion of nonclinical laboratory studies and, as applicable, animal studies;

●
adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed product for its intended use or uses;

●
pre-approval inspection of manufacturing facilities and, in certain cases, clinical trial sites; and

●
FDA review and approval of a marketing application, such as an NDA or BLA, which must occur before a drug or biologic product may be commercially marketed or sold.

We are not permitted to market
our current or future product candidates in the United States until we receive approval of an NDA or BLA from the FDA, as applicable.
In the European Economic Area, we must receive a marketing authorization from the European Commission following review by the European
Medicines Agency, and in other foreign jurisdictions, we must obtain approval from comparable regulatory authorities prior to commercialization.

Post-Market Requirements

If the FDA or comparable foreign
regulatory authorities approve any of our current or future product candidates, the manufacturing processes, labeling, packaging, distribution,
adverse event reporting, storage, advertising, promotion, and recordkeeping for the drug will be subject to extensive and ongoing regulatory
requirements. These requirements include submissions of safety and other post-marketing information and reports, registration, continued
compliance with cGMPs, and compliance with GCPs for any clinical trials conducted post-approval. Regulatory approvals may also be subject
to limitations on the approved indications, conditions of approval, or requirements for additional post-marketing studies, including Phase
IV clinical trials and ongoing safety surveillance.

Later discovery of previously
unknown problems with a product, including adverse events of unanticipated severity or frequency, or issues with our manufacturing processes
or third-party manufacturers, or failure to comply with regulatory requirements, may result in, among other things:

●
restrictions on the marketing or manufacturing of the drug, withdrawal from the market, or product recalls;

●
fines, warning or other letters or holds on clinical trials;

●
refusal by regulatory authorities to approve pending applications or supplements, or suspension or revocation of marketing approvals;

●
seizure or detention of drugs, or refusal to permit the import or export of products; and

●
injunctions or the imposition of civil or criminal penalties.

To produce our product candidates
for clinical trials and any products for commercial purposes, either at our own facilities or at third-party facilities, we and our third-party
vendors must comply with applicable cGMP requirements. As part of our ongoing quality and process improvement efforts, we routinely assess
our quality systems and implement enhancements as necessary to maintain compliance with applicable regulations. Regulatory authorities,
including the FDA and comparable foreign authorities, may inspect our facilities to confirm compliance.

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Animal Health Products

Certain U.S. federal agencies
oversee the regulation of animal health products, including the FDA, the USDA and,
as applicable, the U.S. Environmental Protection Agency (“EPA”). The FDA Center for Veterinary Medicine regulates animal
pharmaceuticals under the Federal Food, Drug, and Cosmetic Act. The EPA regulates certain pesticidal products intended for use in or on
animals.

The USDA, through the Animal
and Plant Health Inspection Service (“APHIS”) and the Center for Veterinary Biologics (“CVB”), regulates veterinary
biologics, including vaccines, diagnostics and immunomodulators, under the Virus-Serum-Toxin Act. APHIS oversees the importation, interstate
movement and environmental release of veterinary biologics, while the CVB evaluates the safety, purity, potency and efficacy of these
products prior to licensure.

The CVB’s licensure
process for veterinary biologics generally includes:

●
Pre-License Evaluation. Review of the manufacturer’s application and supporting data on safety, efficacy, and quality, which may include laboratory and field studies.

●
Licensing Decision. Granting a license if regulatory requirements are met, or requesting additional data if necessary.

●
Labeling Review. Approval of product labeling, including indications, dosage, administration, contraindications, and warnings.

●
Manufacturing Standards. Establishment and enforcement of requirements for facilities, equipment, and procedures, with inspections to ensure compliance.

●
Post-Licensure Surveillance. Ongoing monitoring for safety or efficacy concerns, and requirements for reporting adverse events or conducting post-marketing studies.

Conditional licenses may be
granted for veterinary biologics in special circumstances, such as limited markets or unmet needs, if the product demonstrates a reasonable
expectation of safety and efficacy. Products with conditional licensure may be marketed under specific restrictions and are subject to
follow-up studies to support full licensure. The CVB continues to monitor licensed products, enforce manufacturing standards, and may
require additional data, inspections, or post-marketing studies as needed to ensure ongoing safety and efficacy.

Other Healthcare Laws

If we begin commercializing
any of our current or future product candidates, our operations will be subject to a variety of U.S. federal, state and foreign healthcare
laws and regulations. These laws govern, among other things, the recommendation, prescribing, marketing, distribution and reimbursement
of biopharmaceutical products. Healthcare providers, including physicians, play a central role in prescribing and recommending drugs for
which we obtain marketing approval. Our arrangements with healthcare providers, payors and other customers are subject to requirements
designed to ensure the integrity of these interactions.

U.S. federal laws include,
among others, the Anti-Kickback Statute, which prohibits offering or receiving remuneration to induce or reward the referral or recommendation
of products reimbursable under federal healthcare programs, and the False Claims Act, which imposes penalties for submitting, or causing
the submission of, false or fraudulent claims to the federal government. Analogous state laws may impose similar requirements, including
reporting obligations for payments or other transfers of value to healthcare providers.

Healthcare reform legislation
also influences coverage, pricing and reimbursement for biopharmaceutical products. In the United States, statutes such as the Affordable
Care Act and the Inflation Reduction Act, as well as other federal and state programs, establish requirements for Medicaid and Medicare
drug rebates, coverage determinations, pricing transparency and other programmatic matters. States may also adopt regulations affecting
pricing, reimbursement and product access, including measures that encourage importation, bulk purchasing or competitive bidding. Similar
legislative and regulatory frameworks exist in other countries, where foreign authorities regulate drug approval, reimbursement and healthcare
coverage.

Compliance with these laws
and regulations informs our commercial programs, interactions with healthcare providers and payors, product labeling and pricing strategies.
Government authorities may update, amend or reinterpret these laws, which can affect operational requirements for biopharmaceutical companies.

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Privacy and Data Protection Laws

Our operations may involve
the collection, use, storage and transmission of personal information, including health-related data obtained in connection with clinical
trials, research activities and other business operations. As a result, we are subject to a variety of federal, state, and foreign privacy
and data protection laws and regulations.

HIPAA and HITECH. In
the United States, the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), as amended by the Health Information
Technology for Economic and Clinical Health Act of 2009 (“HITECH”), establishes standards for the privacy and security of
protected health information maintained by healthcare providers, health plans and healthcare clearinghouses, as well as their business
associates. These laws impose requirements relating to the use, disclosure and safeguarding of individually identifiable health information,
including administrative, physical, and technical safeguards and breach notification obligations. HIPAA and HITECH also provide for civil
and criminal penalties for violations and authorize enforcement by the U.S. Department of Health and Human Services and, in certain circumstances,
state attorneys general.

International Data Protection
Laws. Outside the United States, privacy and data protection laws regulate the processing of personal information, including health-related
data. For example, the European Union’s General Data Protection Regulation (“GDPR”) establishes requirements governing
the collection, processing, storage and transfer of personal data and imposes obligations on organizations that process such data. The
GDPR includes restrictions on cross-border data transfers and provides individuals with certain rights regarding their personal data.
The United Kingdom has adopted a similar regulatory framework under the UK GDPR and the Data Protection Act 2018. Compliance with these
frameworks may affect how we collect, process, and transfer personal data in connection with our operations in Europe and other jurisdictions.

U.S. State Privacy Laws.
Several U.S. states have enacted comprehensive privacy laws that regulate the collection and use of personal information. For
example, the California Consumer Privacy Act (“CCPA”), as amended by the California Privacy Rights Act (“CPRA”),
provides California residents with rights regarding their personal information and imposes obligations on covered businesses relating
to disclosures, consumer rights requests, and limitations on certain uses or sharing of personal data. These laws are enforced by state
authorities and may provide private rights of action in certain circumstances. Additional states have adopted or are considering similar
privacy legislation.

Compliance with these privacy
and data protection requirements may affect how we design our clinical trial activities, information systems, data processing practices
and contractual arrangements with third parties that process personal information on our behalf.

Environmental Regulations

Our operations, facilities
and product development activities are subject to a variety of U.S. federal, state, local and foreign environmental, health and safety
laws and regulations. These requirements govern, among other things, air emissions, wastewater discharges, the use and storage of hazardous
substances, the generation and disposal of hazardous and non-hazardous waste, and the remediation of environmental contamination.

Our research and development
and manufacturing-related activities involve the use of hazardous and flammable materials, including chemicals and biological and radioactive
materials, and may generate hazardous waste. We typically rely on third-party contractors for the transport, treatment and disposal of
these materials and wastes.

Environmental regulatory authorities,
including the EPA and comparable state and foreign agencies, administer laws and regulations relating to pollution control, environmental
protection and workplace health and safety. These requirements address, among other matters, emissions to air, discharges to land or water,
and the handling, storage, transportation and disposal of regulated materials. Compliance with these laws and regulations is an ongoing
component of our operations and facility management.

Pricing Regulations and Third-Party
Coverage and Reimbursement

The requirements governing
regulatory approval, pricing and reimbursement for pharmaceutical and biologic products vary significantly among countries. In some jurisdictions,
governmental authorities regulate or approve the price of a drug before it can be marketed, while in others pricing reviews occur after
marketing authorization. In many foreign markets, prescription drug pricing remains subject to ongoing governmental oversight even after
initial approval. As a result, the timing of commercial launch and the price at which products may be marketed can be influenced by regulatory
review and reimbursement determinations.

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The commercial success of
any of our current or future product candidates will depend, in part, on the availability of coverage and reimbursement from government
healthcare programs, private health insurers and other third-party payors. These payors determine whether a product will be covered under
a particular health plan and establish reimbursement levels. In making these determinations, payors typically consider factors such as
the product’s safety and efficacy, clinical value, medical necessity and cost-effectiveness.

Healthcare systems in the
United States and other countries increasingly emphasize cost containment. Government authorities and third-party payors employ a range
of mechanisms to manage pharmaceutical expenditures, including coverage limitations, formulary controls, negotiated discounts and rebates,
and utilization management tools. These policies may influence product pricing, prescribing practices and reimbursement levels.

In the United States, coverage
and reimbursement decisions for many medicines under the Medicare program are administered by the Centers for Medicare & Medicaid
Services (“CMS”), a component of the U.S. Department of Health and Human Services. CMS policies often inform reimbursement
approaches adopted by private payors and other healthcare programs.

Trade Laws

Our global operations are
subject to various U.S. and foreign laws and regulations relating to anti-corruption, anti-money laundering, export controls, economic
sanctions and other international trade matters (collectively, “Trade Laws”). These laws generally prohibit companies and
their employees, agents and other representatives from offering, authorizing or providing improper payments or other benefits to government
officials or private parties in order to obtain or retain business or secure an improper advantage.

In the course of our business,
we may interact with government agencies, government-affiliated hospitals, universities and other public institutions, including in connection
with clinical trials, regulatory approvals and research collaborations. We may also engage third parties, such as contract research organizations,
consultants and other service providers, to support these activities. Trade Laws may apply to our activities and to those conducted on
our behalf by such third parties.

Compliance with applicable
Trade Laws informs our internal policies, procedures and contractual arrangements with third parties engaged in our operations in the
United States and internationally.

Our Competition

The biotechnology and pharmaceutical
industries are highly competitive and characterized by rapid technological advancement, evolving regulatory requirements, and significant
research and development efforts. We face competition from large pharmaceutical companies, biotechnology companies, academic institutions,
government agencies and other research organizations that are developing or commercializing therapies for cancer and rare diseases, including
Osteosarcoma.

While we are not currently
aware of any adjuvant therapy for Osteosarcoma intended for use in pediatric patients that is further advanced in development than OST-HER2,
a number of organizations are developing therapies that may compete with our product candidates. These include product candidates under
development by companies such as AstraZeneca and Y-mAbs Therapeutics, as well as programs being pursued by academic and research institutions,
including MD Anderson Cancer Center.

Competition in this industry
is based on a number of factors, including the ability to successfully develop product candidates, demonstrate safety and efficacy in
clinical trials, obtain regulatory approvals, secure intellectual property protection, establish manufacturing capabilities, obtain reimbursement
from third-party payors and successfully commercialize approved products.

Human Capital and Employees

As of March 26, 2026, we had
four full-time employees and one part-time employee. We also utilize the services of a limited number of consultants as needed to
perform specialized regulatory and medical-related services. Our employees are not represented by labor unions or covered by collective
bargaining agreements. We consider our relationship with our employees to be good. All of our employees have entered into agreements with
our company requiring them not to disclose our proprietary information and assigning to us all rights to inventions made during their
employment.

15

Facilities

Our corporate address is 115
Pullman Crossing Road, Suite 103, Grasonville, Maryland 21638. This space is the accounting office of our Chief Financial Officer and
provided to us rent free. We believe that suitable additional or alternative space would be available in the future on commercially reasonable
terms, if necessary. As of the date of this annual report, all our operations are conducted remotely.

Recent Developments

PIPE Financing

On December 24, 2024, we entered
into a Securities Purchase Agreement (the “PIPE Purchase Agreement”) with certain institutional and accredited investors,
substantially all of whom were existing stockholders, to issue immediately separable units (the “Units”), each consisting
of one share of Series A senior convertible preferred stock (“Series A Preferred Stock”) and one warrant to purchase one share
of common stock (each, a “Series A Warrant”). The Units were sold at $4.00 per Unit (the “PIPE Financing”). At
two closings on December 31, 2024 and January 14, 2025, we issued an aggregate of 1,775,750 shares of Series A Preferred Stock and Series
A Warrants exercisable into 1,775,750 shares of common stock, generating gross proceeds of approximately $7.1 million before fees and
expenses.

Brookline Capital Markets,
a division of Arcadia Securities, LLC, acted as exclusive placement agent for the issuance and sale of the securities in the PIPE Financing.
Brookline Capital Markets, a division of Arcadia Securities, LLC, acted as exclusive placement agent. In connection with the PIPE Financing,
we paid Brookline cash fees totaling $159,685 and $79,723 to Brookline and Brookline’s selected dealer, respectively, plus warrants
to purchase an aggregate of 59,848 shares of common stock (the “Agent Warrants”).

The PIPE Purchase Agreement
required stockholder approval under NYSE American rules for issuances that could exceed 20% of common stock outstanding as of December
24, 2024. On April 9, 2025, we held a Special Meeting of Stockholders, at which the issuance of shares upon (i) conversion of the Series
A Preferred Stock, (ii) exercise of the Series A Warrants, and (iii) exercise of the Agent Warrants, in each case without regard to any
limits on conversion or exercise therein and in amounts collectively equal to or exceeding 20% of our common stock outstanding as of December
24, 2024 (including upon the operation of applicable price reset and anti-dilution provisions and/or the reduction of conversion prices
and exercise prices), was approved by our stockholders.

Acquisition of HER2
Assets

On April 9, 2025, we completed
the acquisition of the HER2 Assets from Ayala. The HER2 Assets include two INDs with the FDA: (i) ADXS-503 for non-small cell lung cancer;
and (ii) ADXS-504 for prostate cancer. In consideration for the purchase of the HER2 Assets, we agreed to assume certain specified liabilities
and to pay an aggregate purchase price of $8,000,000, which was paid as follows: (i) $400,000 to Ayala ($150,000 of which was transferred
upon signing of the HER2 Purchase Agreement and the remainder on the closing date); (ii) $100,000 to a third party on behalf of Ayala
on the closing date; and (iii) $7,500,000 worth of shares of our common stock, or 4,774,637 shares based on the volume-weighted average
price of our common stock over the 30 trading days immediately preceding the closing date.

ATM Equity Offering
Program and Sales

On August 8, 2025, we entered
into an at market issuance sales agreement (the “Sales Agreement”) with B. Riley Securities, Inc. and JonesTrading Institutional
Services LLC (each, a “Sales Agent” and, together, the “Sales Agents”) relating to shares of our common stock.
Pursuant to the Sales Agreement, we may offer and sell shares of our common stock from time to time having an aggregate offering price
of up to $18,000,000 through or to the Sales Agents. We will pay each of the Sales Agents a total commission for its services in acting
as agent in the sale of common stock up to 3.0% of the gross sales price per share of all shares sold through it as agent under the Sales
Agreement. The amount of proceeds we will receive will depend upon the actual number of shares of our common stock sold and the market
price at which such shares are sold. Because there is no minimum offering amount required as a condition to close a sale, the actual total
public offering amount, commissions and proceeds to us are not determinable at this time. Sales of our common stock under the Sales Agreement
are being made pursuant to a prospectus supplement filed with the SEC on August 25, 2025. As of March 26, 2026, we have sold an aggregate
of 282,679 shares of our common stock for aggregate gross proceeds of $530,162 pursuant to the Sales Agreement.

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Warrant Exercise Inducement
and Exchange Offers

On July 11, 2025, we completed
a final closing of a warrant exercise inducement and exchange offer (the “First Inducement Offering”). On September 2, 2025,
we closed on a second warrant exercise inducement and exchange offer (the “Second Inducement Offering”). On January 14, 2026,
we closed on a third warrant exercise inducement and exchange offer (the “Third Inducement Offering” and, collectively with
the First Inducement Offering and Second Inducement Offering, the “Inducement Offerings”). The First Inducement Offering and
Second Inducement Offering were made to holders of certain of our Series A Warrants to purchase shares of our common stock having a then
current exercise price of $1.12 per share.

Pursuant to certain inducement
offer letter agreements, holders of Series A Warrants exercised for cash their Series A Warrants to purchase an aggregate of 7,154,338
shares of our common stock at the then current exercise price of $1.12 per share and in exchange we issued to such holders new warrants
(the “New Warrants”) to purchase up to an aggregate of 7,154,338 shares of our common stock at an exercise price of $3.00
per share, subject to adjustment as provided therein. The New Warrants are immediately exercisable from the date of issuance and have
a term of exercise of five years from such date.

The Third Inducement Offering
was made to less than 10 accredited investors that held New Warrants to purchase up to an aggregate of 5,382,148 shares of our common
stock having a then current exercise price of $3.00 or $2.10 per share. Pursuant to certain inducement offer letter agreements, such holders
of New Warrants exercised for cash their New Warrants to purchase 2,499,558 shares of our common stock at a reduced exercise price of
$1.40 per share and in exchange we issued to such holders new warrants (the “2026 Warrants”) to purchase up to an aggregate
of 2,499,558 shares of our common stock at an exercise price of $1.40 per share, subject to adjustment as provided therein. The 2026 Warrants
are immediately exercisable from the date of issuance and have a term of exercise of five years from such date.

We engaged a SEC-registered
broker dealer and FINRA member (the “Solicitation Agent”) to act as our exclusive warrant solicitation agent in connection
with the Inducement Offerings and paid the Solicitation Agent a cash fee equal to 5.0%, 1.5% and 8.0% of the total gross cash proceeds
received from the exercise by the holders of their respective warrants in connection with the First Inducement Offering, Second Inducement
Offering and Third Inducement Offering, respectively. We also paid the Solicitation Agent $15,000 and $25,000 for its reasonable legal
and other expenses in connection with the First Inducement Offering and Third Inducement Offering, respectively.

The gross proceeds to us from
the Inducement Offerings, before deducting transaction fees and other offering expenses, were approximately $11.5 million. We are using
the net proceeds from the Inducement Offerings to support U.S. and international regulatory and pre-commercial efforts aimed at securing
marketing authorizations for OST-HER2 in the prevention or delay of recurrent, fully resected, pulmonary metastatic Osteosarcoma, provide
funding for our wholly owned subsidiary OS Animal Health’s proposed spin-off transaction preparations, and for general corporate
purposes.

The shares of common stock
underlying the New Warrants have been registered for resale under the Securities Act. We agreed to file a registration statement on Form
S-3 (or other appropriate form, including on Form S-1, if we are not then eligible to register securities on Form S-3) providing for the
resale of the shares of common stock issued or issuable upon exercise of the 2026 Warrants within 30 calendar days of March 2, 2026, and
to use commercially reasonable efforts to have such registration statement declared effective by the SEC within 60 calendar days (or within
90 calendar days in case of “full review” by the SEC) following its initial filing and to keep such registration statement
effective at all times until the earlier of (i) the time no holder owns any 2026 Warrants or shares of common stock issuable upon exercise
thereof and (ii) the Delegend Date (as defined in the inducement offer letter agreements entered into in connection with the Third Inducement
Offering).

Privately Negotiated
Warrant Exercise Inducement and Exchange Agreements

From January 10, 2026 through February 2026, we entered into privately
negotiated inducement offer letters, pursuant to which certain remaining holders of our New Warrants exercised for cash their New Warrants
to purchase an aggregate of 123,216 shares of our common stock at a reduced exercise price of $1.40 per share and in exchange we issued
new warrants to purchase up to an aggregate of 123,216 shares of our common stock at an exercise price of $1.40 per share, subject to
adjustment as provided therein. Such new warrants are immediately exercisable from the date of issuance and have a term of exercise of
five years from such date. We received gross proceeds of approximately $172,502 from the exercise of these New Warrants.

17

We agreed to file a registration
statement on Form S-3 (or other appropriate form, including on Form S-1, if we are not then eligible to register securities on Form S-3)
providing for the resale of the shares of common stock issued or issuable upon exercise of these warrants on or before March 30, 2026,
and to use commercially reasonable efforts to have such registration statement declared effective by the SEC within 60 calendar days (or
within 90 calendar days in case of “full review” by the SEC) following its initial filing and to keep such registration statement
effective at all times until the earlier of (i) the time no holder of these warrants owns any such warrants or shares of common stock
issuable upon exercise thereof and (ii) the Delegend Date (as defined in the privately negotiated inducement offer letters).

2026 Bridge Financing

On March 4, 2026, pursuant
to a securities purchase agreement (the “Bridge SPA”), we issued to certain accredited investors in a private placement transaction
(i) 10.0% original issue discount unsecured convertible promissory notes in an aggregate principal amount of $2,200,000 (the “Bridge
Notes”) and (ii) warrants to purchase up to an aggregate of 1,666,667 shares of our common stock (the “Bridge Warrants”
and such private placement transaction, the “Bridge Financing”), for aggregate gross proceeds of $2,000,000, before deducting
placement agent fees and other Bridge Financing expenses. The Bridge Notes mature on March 4, 2027 and accrue interest at a rate of 4.0%
per annum. The Bridge Warrants were immediately exercisable upon issuance, expire five years from the date of issuance and have an exercise
price of $1.40 per share, subject to adjustment as provided therein.

The Bridge Notes were sold
at a 10% original issue discount, such that for each $100,000 invested by a purchaser, such purchaser received a Bridge Note in the principal
amount of $110,000. The Bridge Notes are convertible into shares of our common stock under certain circumstances. If we complete a “Qualified
Offering,” defined as a registered public offering or registered direct offering resulting in at least $2.5 million in gross proceeds
from new money investments, the outstanding principal, together with all accrued and unpaid interest, will automatically convert into
the securities sold in such offering at the offering price. Additionally, prior to any such Qualified Offering or repayment of the Bridge
Notes, holders may elect to convert the Bridge Notes, in whole or in part, into shares of our common stock at a conversion price equal
to 90% of the average daily volume-weighted average price of our common stock during the 10 trading days immediately preceding the holder’s
conversion notice, subject to adjustment.

We intend to use the net proceeds
of the Bridge Financing to fund clinical development activities, including ongoing and planned clinical trials, and advance our research
and development programs, as well as for working capital and general corporate purposes.

We engaged a SEC-registered
broker dealer and FINRA member to act as the exclusive placement agent for the Bridge Financing. In connection with the Bridge Financing,
we paid to the placement agent (a) a cash fee equal to 7.0% of the aggregate gross cash proceeds received by us in connection with the
Bridge Financing and (b) a one-time expense reimbursement of $25,000 for its legal and other expenses incurred in connection with the
Bridge Financing.

We agreed to file a registration
statement on Form S-3 (or Form S-1 if we are not then eligible to register securities for Form S-3) by April 3, 2026 to register for resale
the shares of our common stock issuable upon conversion of the Bridge Notes and exercise of the Bridge Warrants, and to use commercially
reasonable efforts to cause such registration statement to become effective within 60 calendar days (or 90 calendar days in the case of
a “full review” by the SEC) following its initial filing and to keep such registration statement effective at all times until
the earlier of (i) the time that no investor owns any Bridge Notes, Bridge Warrants or shares underlying such Bridge Notes and Bridge
Warrants or (ii) the Legend Removal Date (as defined in the Bridge SPA).

Other Information

We were formed as a Delaware
limited liability company on April 12, 2018 under the name OS Therapies, LLC. On June 24, 2019, we converted from a limited
liability company to a Delaware corporation and changed our name to OS Therapies Incorporated. We completed our initial public offering
in August 2024 and our common stock is currently listed on NYSE American under the symbol “OSTX.”

We presently conduct all of
our operations remotely. Our registered corporate address is 115 Pullman Crossing Road, Suite #103, Grasonville, Maryland 21638, and our
telephone number is (410) 297-7793. Our website address is www.ostherapies.com. We make available on this website, free of charge,
our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports pursuant
to Section 13(a) or 15(d) of the Exchange Act as soon as reasonably practicable after we electronically file such material with, or furnish
such information to, the SEC. Reports and other information we file with the SEC may also be viewed at the SEC’s website at www.sec.gov.
The information contained on, or that can be accessed through, our website is not incorporated by reference into this report.

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