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Item 1. Business

2026-03-31 compared with 2025-03-31 · 788 added, 779 removed, 255 unchanged (86% of the section changed)

Overview and Mission

Therapies Incorporated (“OS Therapies,” the “Company,” “we,” “our” or “us”)

is a clinical stage biopharmaceutical company focused on the identification,

development and commercialization of treatments for Osteosarcoma (OS) and other solid tumors.

Our mission is to address the significant

need for new treatments in cancers of the bone in children and young adults.

Osteosarcoma is an extremely challenging and often aggressive

cancer that has particular treatment challenges due to its location, changing genotypes and high recurrence rates.

We are currently seeking

to answer the call for new treatments with our lead core product candidate OST-HER2 (also known as OST31-164).

We intend to expand our

pipeline beyond Osteosarcoma with this product candidate into other solid tumors with the same recurrence mechanism of action, including

breast, esophageal and lung cancers.

With the addition of our OST-Tunable Drug Conjugate (OST-tADC) platform, which we consider to be

a next generation antibody-drug conjugate (ADC) technology, we will be targeting ovarian, lung and pancreatic cancers.

OS Therapies Incorporated

(“OS Therapies,” the “Company,” “we,” “our” or “us”) is a clinical stage biopharmaceutical

company focused on the identification, development and commercialization of treatments for Osteosarcoma (OS) and other solid tumors.

mission is to address the significant need for new treatments in cancers of the bone in children and young adults.

Osteosarcoma is an

extremely challenging and often aggressive cancer that has particular treatment challenges due to its location, changing genotypes and

high metastases rates.

We are currently seeking to answer the call for new treatments that will prevent metastasis and the recurrence

of metastases with our lead core product candidate OST-HER2 (also known as OST31-164), a cancer immunotherapy product candidate that produces

a cellular immune response against the cancer antigen HER2.

In 2021, we opened a clinical

study to produce data for the U.S.

Food and Drug Administration (FDA) to evaluate the safety and efficacy of OST-HER2 in patients after

resection of recurrent Osteosarcoma, which achieved full enrollment of 41 patients in October 2023.

In the first quarter of 2025, we announced

that our Phase IIb clinical trial achieved its primary endpoint with statistical significance.

In October 2025, we announced final two-year

overall survival data from the Phase IIb trial, in which 75% (27 of 36 evaluable patients) of OST-HER2-treated patients achieved two-year

overall survival from the most recent pulmonary resection, compared with 40% in historical control patients (p < 0.0001).

was observed to be well-tolerated in the study.

In January 2026, we announced positive immune biomarker data from the Phase IIb trial

indicating that activation of immune blood biomarkers in the interferon gamma pathway correlated with, and was predictive of, overall

survival, distinguishing long-term survivors (≥ two years) from short-term survivors (< one year).

These biomarker findings are

based on exploratory analyses and have not been validated as surrogate endpoints for clinical benefit.

Based on the totality of the data

generated to date, including the observed survival outcomes, safety profile and the significant unmet medical need in this patient population,

we intend to engage with the FDA regarding potential regulatory pathways for OST-HER2.

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.

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.

is a term used in drug development that refers to the properties that can be influenced by chemical modifications, and “antibody-drug

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active and toxic pharmaceutical molecule, through chemical linkers.

The ADC links an antibody that can home in on a targeted tumor like

and deploy the cytotoxic payload or toxic agent against the tumor.

Furthering our founding mission, we also intend to investigate clinical

indications for OST-tADC in Osteosarcoma.

We believe that there have

not been any new treatments approved by the U.S.

Food and Drug Administration (FDA) for Osteosarcoma for more than 40 years.

In humans, Osteosarcoma is an extremely rare cancer that primarily affects children, teenagers and young adults generally under 40 years

We are not aware of any competing adjuvant therapy for Osteosarcoma to be tested in children that is further along in the development

process than OST-HER2.

This disease is difficult to diagnose.

The standard of care following first line therapies is simply to screen

and wait for possible recurrence/metastasis, or the development of secondary malignant growths at a distance from a primary site of cancer.

Studies published in the Journal of Clinical Oncology, “Osteosarcoma Relapse After Combined Modality Therapy:

An Analysis of Unselected

Patients in the Cooperative Osteosarcoma Study Group (COSS),” by Kempf-Bielack B., et al.

(January 2005), and “Second

and Subsequent Recurrences of Osteosarcoma:

Presentation, Treatment, and Outcomes of 249 Consecutive Cooperative Osteosarcoma Study Group

Patients,” by Bielack S., et al.

(February 2009), reported that recurrence/metastasis happens in approximately half of all

patients within 12 to 18 months following initial remittance.

For those patients that experience recurrence, metastasis is typically

to the lungs and brain, with survival rates of approximately 13% over the next year, according to these studies.

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

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silicone linkers (SiLinkers™).

The payloads may include antibodies, chemotherapeutics, cytotoxins and potentially mRNA treatments directly

into and in the vicinity of solid tumors.

The payloads may include antibodies, chemotherapeutics, cytotoxins and potentially mRNA treatments

directly into and in the vicinity of solid tumors.

OST-HER2 (OST31-164).

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the membrane of the bacteria.

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 new cases 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.

In May 2024, we submitted a request to the FDA for breakthrough therapy

designation for OST-HER2.

Such designations by the FDA do not convey any advantages or shorten the duration of the regulatory review or

approval process.

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.

tunable drug conjugate (tADC) platform is currently in preclinical development.

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payload is released, to cause cell death.

The payload cassette adaptors enable the stoichiometrical attachments of linkers and payloads.

The payload cassette adapters enable the stoichiometrical attachments of linkers and payloads.

The SiLinkers represent a novel and pH-sensitive linker system.

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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, as

This discovery work is being carried out at Syngene International Limited, an integrated contract research organization (CRO)

based in Bangalore, India.

a small molecule, as the targeting ligands and contains six exatecan-silanols, which is a type of silanol-based cytotoxic payload.

discovery work is being carried out at Syngene International Limited, an integrated contract research organization (CRO) based in Bangalore,

From time to time, we may

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Clinical Trials and Studies — Preclinical Animal Study ” for more information.

Our Pending Acquisition of HER2 and Lm -Related

On January 28, 2025, we entered

into an Asset Purchase Agreement (the “HER2 Purchase Agreement”) with Ayala Pharmaceuticals, Inc., a Delaware corporation

Our Acquisition of HER2 and Lm -Related

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”), pursuant to which we agreed, subject to the terms and conditions set forth therein,

to acquire from Ayala Lm -based immuno-oncology programs and related intellectual property assets (collectively, the “HER2

The HER2 Assets include two investigational new drug (IND) filings with the FDA:

(i) ADXS-503 for non-small cell lung

and (ii) ADXS-504 for prostate cancer.

The closing of the transaction, which we expect to in the second quarter of 2025, is subject

to assignment of a license between Ayala and the Trustees of the University of Pennsylvania (the “Penn License”), execution

and delivery of a patent assignment agreement, a termination of license agreement, a lock-up agreement and a registration rights agreement,

the approval of the transaction by Ayala stockholders and other customary closing conditions.

(“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 licensors have

conducted a number of clinical trials and studies in the field of Osteosarcoma and Tunable Drug Conjugates to date.

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

In July 2021, a Phase IIb clinical trial to treat Osteosarcoma in humans was commenced

and sponsored by us and conducted by George Clinical, Inc., our clinical research services provider, utilizing our OST-HER2 product candidate.

The course of the trial involved a regimen of 16 infusions of OST-HER2 administered over 48 weeks to 41 eligible patients from ages

12 to 39 years.

As of September 30, 2024, the treatment phase of the trial has been completed, and patients are now being followed

for long-term survival.

This Phase IIb trial was conducted at major hospitals across 21 sites in 18 states.

On January 15, 2025, we announced

that our Phase IIb clinical trial achieved its primary endpoint with statistical significance.

The primary outcome measures were the relative

proportion of patients experiencing event-free (recurrence-free) survival at 12 months (“Responders”) compared to the best

available historical control group from U.S.

published literature (the “Published Control”) by evaluating the patients for

recurrence every 3 months, consistent with the standard of care.

Trial results showed that 33% of OST-HER2 treated patients were Responders

compared to 20% in the Published Control.

The secondary outcome measures

were overall survival of patients for three years compared to the three-year overall survival of the Published Control, which will

be evaluated by assessing patients every three months over the course of three years, and the incidence of treatment-emergent

adverse events as assessed by Common Terminology Criteria for Adverse Events (CTCAE) Grade 5, the safety of which will be assessed throughout

the treatment period of 48 weeks with assessments of potential persistence of the vector every three months and continuing for

three years after treatment.

CTCAE is a method to categorize adverse events across all clinical trials of five grades, with Grade

5 being death.

Trial results showed a higher proportion of OST-HER2 treated patients were alive at the 12-month (91% vs.

80%) and 24-month

40%) post-resection timepoints relative to the Published Control.

Notably, 100% of patients who were disease-free at 12 months

remained alive at 12, 18, 24, and 30 months at their last follow-up.

OST-HER2 was well tolerated with a safety profile supportive of regulatory

no treatment-emergent adverse events classified as CTCAE Grade 5 (death) were observed.

We believe the efficacy results,

combined with the favorable safety profile and the unmet clinical need, support the potential for regulatory approval.

We plan to request

a Type B or Type C FDA meeting in the first quarter of 2025 to discuss the data and the path to a BLA.

Subject to positive FDA feedback,

we plan to submit a BLA with the FDA CBER for approval to market the drug candidate in the second quarter of 2025.

The FDA generally takes

six to ten months to complete its review of a BLA, subject to any FDA request for additional information.

We believe that it remains

uncertain whether a Phase III clinical trial will be necessary for the advancement of OST-HER2 through the regulatory approval process.

We will not know whether a Phase III trial will be required until we receive a determination from the FDA following the filing of

a BLA for marketing approval as to whether the results of our ongoing Phase IIb trial provided sufficiently positive endpoint data.

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.

was conducted at major hospitals across 21 clinical sites in 18 U.S.

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.

(the “Published Control”), with recurrence assessments conducted every three months in accordance with standard of care.

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 <

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).

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.

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

From September 2015 to May 2017, a Phase Ib trial to treat Osteosarcoma in humans

was sponsored and conducted by Advaxis utilizing ADXS-HER2 (also known as ADXS31-164), the patents of which we agreed to purchase from

Ayala to develop and commercialize our lead core product candidate, OST-HER2.

The Phase Ib was a multicenter, open-label, dose-escalation

study designed to estimate the maximum tolerated dose (MTD) and determine the recommended Phase II dose of ADXS-HER2.

The trial was

conducted at hospitals in Colorado, Michigan, North Carolina, Pennsylvania and Texas.

The course of the trial involved injecting 12 adult

patients with HER2 expressing solid tumors with escalating doses of ADXS-HER2 every three weeks during a 12-week treatment cycle.

Following the last dose of study treatment, all 12 patients participated in a three-year Listeria monocytogenes surveillance period.

The primary outcome measures

were the number of patients with dose-limiting toxicities for each dose level as assessed by the CTCAE Grade 4 (time frame:

four months),

with Grade 4 being life threatening, and the frequency and severity of adverse effects as assessed by CTCAE Grade 4 (time frame:

three years).

The secondary outcome measures were (i) proportion of patients who have objective tumor response (complete or partial) evaluated

by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and RECIST-based immune criteria (ir-RECIST) and (ii) changes in

clinical immunology based upon serum, which were measured and evaluated by collection of peripheral blood for preparation of peripheral

blood mononuclear cells and serum at baseline, prior to each treatment and post-treatment in the first treatment cycle only.

of this study were primarily intended to describe the safety and tolerability of ADXS-HER2.

This study was not intended to contribute

to the evaluation of the effectiveness of ADXS-HER2 for the treatment of patients with a history of HER2 expressing tumors.

data presented from this Phase Ib trial demonstrated that ADXS-HER2 IV infusion at the dose of 1×10 9 CFU appeared

to be well tolerated in 12 subjects treated and evaluable with no evidence of dose-limiting toxicities.

No objective tumor responses (complete

or partial) were observed in this late stage, heavily pre-treated patient cohort.

Based on the data presented, the recommended Phase II

dose of ADXS-HER2 was determined to be 1x10 9 CFU as it was well tolerated.

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 × 10 9 colony-forming units (“CFU”)), and no maximum

tolerated dose was reached.

ADXS-HER2 administered intravenously at 1 × 10 9 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 × 10 9 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.

July 2012 to September 2015, a preclinical study to treat Osteosarcoma in 18 companion canines (sometimes referred to as a Phase I

animal trial) was sponsored and conducted by a previous licensee of Advaxis utilizing ADXS-HER2, the product candidate of Advaxis, from

whom we agreed to purchase patents for ADXS-HER2 constructs that enable us to develop OST-HER2.

The results showed, in the setting of

minimal residual disease where there is a very small number of cancer cells remaining in the body during or after initial treatment, significant

improvements in overall survival and metastatic disease progression when compared to an historical control group with Human Epidermal

Growth Factor Receptor 2-positive (HER2) appendicular Osteosarcoma, a well-recognized spontaneous model for pediatric Osteosarcoma, treated

with amputation and chemotherapy alone.

In September 2016, the study results, published in the journal, Clinical Cancer Research,

“Immunotherapy with a HER2-Targeting Listeria Induces HER2-Specific Immunity and Demonstrates Potential Therapeutic Effects in a

Phase I Trial in Canine Osteosarcoma,” by Mason, N.

( https://pubmed.ncbi.nlm.nih.gov/26994144/ ), indicated that

ADXS-HER2 significantly increased the duration of survival time and one-, two- and three-year survival rates and significantly reduced

the incidence of metastatic disease (the spread of cancer cells from an initial or primary site to a different or secondary site within

the host’s body) when compared with the historical control group.

The overall survival rates at one, two and three years for

dogs treated with ADXS-HER2 were 77.8%, 67% and 56%, respectively, compared to 55%, 28% and 22%, respectively, for the historical control

The median survival time (MST) for the historical control group was 423 days, which was significantly shorter than the 956 days

for ADXS-HER2 — treated dogs (p=0.014, HR 0.33;

95% confidence intervals;

CI, 0.136 – 0.802).

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.

In analyzing preclinical study

results, a p-value is used to determine the probability as to whether the difference between two data sets is due to chance.

the p-value, the more likely the differences are not due to chance alone.

In general, if the p-value is less than or equal to 0.05, the

outcome is considered statistically significant.

The FDA’s evidentiary standard of efficacy generally relies on a p-value of less

than or equal to 0.05.

A p-value greater than 0.05 is considered statistically non-significant.

As shown above, the results of this preclinical

study were statistically significant compared to the historical control group.

Following the study, an application

for the use of ADXS-HER2, our OST-HER2, in the treatment of canine Osteosarcoma was submitted to the USDA.

In December 2017,

ADXS-HER2 was granted a conditional license by the USDA.

Because we are the current licensee of ADXS-HER2 constructs, we held the

conditional license previously granted to ADXS-HER2 for OST-HER2.

The conditional license allowed for commercialization but limited the

use of OST-HER2 to treat dogs, one year of age and older, diagnosed with Osteosarcoma.

We allowed such conditional license to lapse as

a result of improvements made in our manufacturing process that would improve the performance in canines, and we plan to request from

USDA a new conditional license for the product once we have contracted for manufacture with a suitable USDA licensed contract manufacturer.

To receive full licensure, the USDA requires the submission of additional data that further describes the effects of OST-HER2 on metabolism

and shedding in canines and provides substantial evidence of the safety, purity, potency and effectiveness of OST-HER2.

We are currently

evaluating the best path to development.

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

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;

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.

for canine Osteosarcoma indications constituted preclinical work as it relates to our development of OST-HER2 to treat Osteosarcoma in

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.

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

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.

OST-HER2 product candidate for breast, esophageal, lung and other solid tumor indications is currently in preclinical development.

additional preclinical trials will be required will depend on several factors, including the outcome of our ongoing Phase IIb clinical

trial, the inclusion or exclusion of breast, esophageal, lung or other solid tumor indications in any follow-on study, or master protocol,

to the Phase IIb clinical trial and the FDA’s determination of whether the preclinical data is sufficient to support the safety

and efficacy of the drug.

Although we cannot be certain, we believe that OST-HER2 may not require additional preclinical development before

progressing to human clinical trials for breast, esophageal, lung and other solid tumor indications if the results of our ongoing Phase IIb

clinical trial have sufficiently positive endpoint data as determined by the FDA.

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

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To achieve our goal, we are pursuing the following growth strategies:

● Consider potentially out-licensing OST-HER2 to animal health companies for veterinary use to treat dogs

diagnosed with Osteosarcoma, one year of age or older.

● 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.

● Conclude pre-clinical and toxicology trials with the lead drug candidate for OST-tADC (OST-tADC-A, Exatecan-silanol-FRa),

and file for an IND to initiate a Phase I trial in ovarian cancer and other folate receptor alpha overexpressing cancers like endometrial

cancer and some osteosarcomas.

We believe that positive results from preclinical two-week and good laboratory practice (GLP) toxicology

studies may also stimulate potential out-licensing activity of SiLinker and CAPs drug products, while not limiting therapeutic development.

● Establish global commercial and medical affairs capabilities for OST-HER2 based therapies.

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.

Expansion Opportunities

We believe opportunities may

exist from time to time to expand our current business through acquisitions or in-licenses of complementary products or technologies or

acquisitions of companies with complementary products or technologies.

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 are also aware of increased

acquisition and licensing interest from large pharmaceutical firms in biotechnology companies developing ADC technology as a relatively

new kind of cancer therapy.

In the article, “Seagen Cancer Therapy Draws Suitors” (March 7, 2023), The Wall Street Journal

reported that driving this interest, according to analysts, is the potential for ADCs to capture a chunk of the worldwide cancer market.

Technical advances by combining the ADCs with widely used cancer agents like immunotherapies have also opened up exploring various potential

cancer applications, according to the article.

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.

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.

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

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and kinase selectivity.

OST-HER2’s compositions and methods of use are covered by three granted U.S.

OST-HER2’s compositions and methods of use are covered by two granted U.S.

utility patents and one

granted Japanese patent that we in-license through our development license and supply agreement with Advaxis and were developed at the

University of Pennsylvania and are owned by the University of Pennsylvania, either jointly with Advaxis or solely by the University.

“ Our Licensing Agreements — Advaxis ” and “ Our Intellectual Property ” below.

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

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Scientific Advisory

We have established a scientific advisory board comprised of seven 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.

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:

Ahmed, MD — Texas Children’s Hospital

Ahmed, MD — Texas

Children’s Hospital

Anderson, MD — Cleveland Clinic

Hawkins, MD — Seattle Children’s Hospital

Meenakshi Hedge, MD — Texas Children’s Hospital

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Patient Advocacy Advisory

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

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.

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.

Our patient advocacy advisory

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Olivia Egge — Founding Member, Counsel and Patient Advocate of Osteosarcoma Collaborative;

Graduate student at Columbia University School of Professional Studies;

MD candidate at David Geffen School of Medicine at UCLA;

Osteosarcoma Survivor

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Tony Trent — President of The Tyler Trent Foundation

Serena Subada — OST-HER2 Trial Participant

ADC Advisory Board.

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.

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.

We have established an ADC advisory board comprised of two members with extensive experience with ADC technologies.

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

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● Borys Shor, Ph.D.

— President and Chief Executive Officer of Manhattan BioSolutions, Inc.

and Chief Executive Officer of Manhattan BioSolutions, Inc.

● Jutta Wanner, Ph.D.

— Senior Vice President of Drug Discovery at Alpha-9 Oncology, Inc.

Vice President of Drug Discovery at Alpha-9 Oncology, Inc.

● Colin Goddard, Ph.D.

at BlinkBio, Inc.

Some of the members of our

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Hospitals, medical centers and companies with which advisory board members are involved may in the future have commercial relationships

Our Licensing Agreements

Our Licensing Obligations

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 allows us to utilize Advaxis’ ADXS-HER2 construct patents to develop and commercialize ADXS-HER2,

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 January 28, 2025, we entered into the HER2 Purchase Agreement with Ayala, pursuant to which

we agreed, subject to the terms and conditions set forth therein, to acquire from Ayala the HER2 Assets.

The closing of the transaction,

which we expect to occur in the second quarter of 2025, is subject to assignment of the Penn License, execution and delivery of a patent

assignment agreement, a termination of license agreement, a lock-up agreement and a registration rights agreement, the approval of the

transaction by Ayala stockholders and other customary conditions.

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.

August 2020, we entered into a licensing agreement with BlinkBio, Inc., pursuant to which BlinkBio granted a license to us that allows

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In connection with the license agreement, we also agreed to issue a convertible note to BlinkBio.

See “ Management’s

Discussion and Analysis of Financial Condition and Results of Operations ” for more information on our licensing agreements and

the BlinkBio convertible note.

Our Research Services Agreement

George Clinical.

June 2020, we entered into a services agreement, as amended, with George Clinical, Inc., a clinical contract research organization.

Pursuant to this agreement, we engaged George Clinical to use its clinical research services for our study entitled “An Open Label,

Phase 2 Study of Maintenance Therapy with OST-HER2 after Resection of Recurrent Osteosarcoma.”

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);

Food and Drug Administration (FDA, United States).

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.

terms of the license agreement, we are required to pay an annual license fee to the Trustees of the University of Pennsylvania.

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;

● 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 research services agreement

with George Clinical.

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

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candidate OST-HER2, our other core product candidate OST-tADC, our non-core product candidates, our proprietary compound library and other

We seek to protect our proprietary and intellectual property position by, among other methods, in-licensing 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.

Although we have agreed to

acquire the HER2 Assets pursuant to the HER2 Purchase Agreement, we do not currently own any issued patents.

We in-license patents and

patent applications related to our lead core product candidate OST-HER2 from Advaxis, Inc.

and our other core product candidate OST-tADC

from BlinkBio, Inc.

The intellectual property licensed from Advaxis, Inc.

includes nine granted U.S.

utility patents and a number

of foreign patents and pending patent applications.

The patents and patent applications if granted are expected to expire between 2030

and 2035, not including any patent term extension.

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

The intellectual property licensed from BlinkBio, Inc.

includes six granted U.S.

utility patents

and a number of foreign patents and pending patent applications.

The patents cover methods of use of silicon based drug conjugates and

silanol based therapeutic payloads.

The patents and pending patent applications if granted are expected to expire between 2036 and 2037,

not including any patent term extension.

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

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We cannot provide any assurances that

any of the patents that we 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.

if the breadth or strength of protection provided by such patent applications or any patents we may in-license is threatened, it

could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates.

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

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after issuance.

In addition, any patent we may own or in-license may be challenged, circumvented or invalidated by third parties.

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.

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.

Factors — Risks Related to Our Intellectual Property ” for a more comprehensive description of risks related

to our intellectual property.

Our Commercialization Strategy

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We rely, and expect to continue to rely, on third parties for

the manufacture of our product candidates for preclinical and clinical testing, as well as for commercial manufacturing if any of our

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.

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Preclinical Studies and IND

The preclinical developmental

stage generally involves laboratory evaluations of drug chemistry, formulation and stability, as well as studies to evaluate toxicity

in animals, which support subsequent clinical testing.

The sponsor must submit the results of the preclinical studies, together with manufacturing

information, analytical data, any available clinical data or literature and a proposed clinical protocol, to the FDA as part of the IND.

IND is a request for authorization from the FDA to administer an investigational product to humans, and must become effective before human

clinical trials may begin.

Preclinical studies include

laboratory evaluation of product chemistry and formulation, as well as in vitro and animal studies to assess the potential for

adverse events and in some cases to establish a rationale for therapeutic use.

The conduct of preclinical studies is subject to federal

regulations and requirements, including GLP regulations for safety/toxicology studies.

An IND sponsor must submit the results of the preclinical

tests, together with manufacturing information, analytical data, any available clinical data or literature, and plans for clinical trials,

among other things, to the FDA as part of an IND.

Some long-term preclinical testing, such as animal tests of reproductive adverse

events and carcinogenicity, may continue after the IND is submitted.

An IND automatically becomes effective 30 days after receipt

by the FDA, unless before that time the FDA raises concerns or questions related to one or more proposed clinical trials and places the

trial on clinical hold.

In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical trial can

As a result, submission of an IND may not result in the FDA allowing clinical trials to commence.

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

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

(i) in compliance with federal regulations;

(ii) in compliance with good clinical practice (“GCP”) an international

standard intended to protect the rights and health of patients and to define the roles of clinical trial sponsors, investigators, and

and (iii) under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety, and the

effectiveness criteria to be evaluated.

Clinical trials are typically conducted at geographically diverse clinical trial sites and are

designed 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 when considering whether a drug satisfies the statutory standard for commercialized.

Clinical trials must be approved in the

United States by an Institutional Review Board (“IRB”), an appropriately constituted group that has been formally designated

to review and monitor biomedical research involving human subjects and which has the authority to approve, require modifications in, or

disapprove research to protect the rights, safety and welfare of the human research subject.

In other countries, clinical trials may be

subject to review and approval by ethics boards similar to IRBs.

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 either

is not being conducted in accordance with the FDA requirements or presents an unacceptable risk to the clinical trial patients.

may also require the clinical trial it has approved to be halted, either temporarily or permanently, for failure to comply with the IRB’s

requirements, or may impose other conditions or sanctions.

The FDA’s current good

manufacturing practices (cGMPs) apply to drug product candidates in Phase II and Phase III clinical trials;

thus, the product

candidates in those trials must be manufactured in compliance with cGMPs.

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.

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.

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.

We have not received approval to market any of our

current product candidates.

We expect to rely on third-party CROs and/or regulatory consultants to assist us in this process.

regulatory approval requires the submission of extensive preclinical and clinical data and supporting information to the various regulatory

authorities for each therapeutic indication and line of treatment to establish the product candidate’s safety and efficacy.

regulatory approval also requires the submission of information about the drug manufacturing process to, and further requires inspection

of manufacturing facilities by, the relevant regulatory authority.

The process required by the

FDA before biopharmaceuticals may be marketed in the United States generally involves the following:

● nonclinical laboratory and, at times, animal tests;

● adequate and well-controlled human clinical trials to establish the safety and efficacy of the proposed

drug for its intended use or uses;

● pre-approval inspection of manufacturing facilities and some clinical trial sites;

● FDA approval of an NDA or a BLA, which must occur before a drug or biologic product can be marketed or

any of our current or future product candidates, we must obtain marketing approval from the applicable regulatory authorities.

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.

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;

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 until we receive approval of a BLA from the FDA CBER in the United States or a marketing

authorization application from the European Medicines Agency in the European Economic Area or until we receive approval of comparable

agencies in other foreign countries.

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 a comparable

foreign regulatory authority approves 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,

as well as continued compliance with cGMPs and Good Clinical Practices (“GCPs”) for any clinical trials that we conduct post-approval.

Any regulatory approvals that we receive for our current or future product candidates may also be subject to limitations on the approved

indicated uses for which the drug may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing

testing, including Phase IV clinical trials, and surveillance to monitor the safety and efficacy of the drug.

Later discovery of

previously unknown problems with a drug, including adverse events of unanticipated severity or frequency, or with our third-party manufacturers

or manufacturing processes, or failure to comply with regulatory requirements, may result in, among other things:

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

drug recalls;

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 the FDA to approve pending applications or supplements to approved applications filed by us,

or suspension or revocation of drug license approvals;

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

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;

injunctions or the imposition of civil or criminal penalties.

In order to produce our product

candidates for clinical trials and our products, if any, for commercial purposes, either at our own facility or at a third-party’s

facility, we and our third party vendors will need to comply with the FDA’s cGMP regulations and guidelines.

As part of our ongoing

quality and process improvement efforts, we conducted a gap analysis of our cGMP quality system and it identified certain key areas for

necessary remediation, including with regard to documentation requirements.

We are subject to inspections by the FDA and comparable foreign

regulatory authorities to confirm compliance with applicable regulatory requirements.

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.

Animal Health Products

regulatory agencies are charged with oversight and regulatory authority of animal health products in the United States.

These agencies,

depending on the product and its intended use, may include the FDA, the U.S.

Department of Agriculture (“USDA”) and the

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 (“CVM”) regulates animal

pharmaceuticals under the Food, Drug and Cosmetics Act.

The EPA is responsible for regulating pesticides, which include some products

used for controlling pests and diseases in animals.

of Agriculture .

The regulation of veterinary biologics is overseen by the USDA, specifically the USDA Animal

and Plant Health Inspection Service (“APHIS”) and the USDA Center for Veterinary Biologics (“CVB”).

and CVB are responsible for regulating veterinary vaccines and some biologics pursuant to the Virus-Serum-Toxin Act.

The APHIS is responsible

for protecting animal health by regulating the importation, interstate movement and environmental release of veterinary biologics.

includes overseeing the importation and exportation of veterinary biologics, issuing permits for the movement of these products across

state lines, and regulating the release of genetically engineered veterinary biologics into the environment.

The CVB is responsible for

ensuring the safety, purity, potency and efficacy of veterinary biologics, including vaccines, diagnostics, and other biologics used in

The CVB evaluates the safety and efficacy of these products before granting them approval for use in animals.

The CVB also oversees

the manufacturing, testing, labeling and distribution of veterinary biologics and monitors their ongoing safety and effectiveness.

USDA Center for Veterinary

The CVB reviews and approves applications for veterinary biologics, including vaccines, immunomodulators,

diagnostic kits and other biologic products.

The CVB evaluates the safety, efficacy and quality of each product and grants licenses for

products that meet the necessary regulatory requirements.

The licensure process for veterinary biologics involves several key steps, including:

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

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.

Before a veterinary biologic can be licensed, the manufacturer

must submit an application to the CVB.

The CVB reviews the application and evaluates the data on the product’s safety, efficacy

This evaluation may include laboratory studies, field studies and other relevant information.

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

Licensing Decision.

Based on its evaluation, the CVB may grant a license for the

product or require additional data or studies before making a final decision.

If the CVB determines that the product meets all necessary

regulatory requirements, it grants a license for the product.

Once a product is licensed, the manufacturer must submit labeling for

the product to the CVB for approval.

The labeling must include specific information on the product’s indications, dosage, administration,

contraindications and warnings.

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.

The CVB establishes and enforces manufacturing standards

for veterinary biologics, including requirements for facilities, equipment and procedures.

The CVB conducts inspections of manufacturing

facilities to ensure compliance with these standards and may revoke licenses for manufacturers that fail to comply.

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

Post-Licensure Surveillance.

The CVB monitors veterinary biologics after they are

licensed to detect and respond to any safety or efficacy issues that may arise.

The CVB may require manufacturers to conduct post-licensure

surveillance studies or to report adverse events associated with their products.

Conditional licenses are used

to meet an emergency condition, limited market, local situation or other special circumstance.

A product may be granted a conditional

license if it has demonstrated a reasonable expectation of efficacy and safety, but additional data is needed to fully evaluate its efficacy

To be eligible for conditional licensure, a veterinary biologic must meet certain regulatory criteria, including:

● the product must be intended for use in a target species for which there is a significant need;

● the product must have demonstrated a reasonable expectation of efficacy and safety based on preclinical

and/or field studies;

● the product must have an acceptable safety profile;

● the manufacturer must submit a plan for follow-up studies to address the data gaps or uncertainties identified

during the evaluation process.

A product with conditional

licensure can be marketed and sold, but it must be labeled with specific conditions, such as limitations on use, required follow-up studies

and other specific instructions for use.

The product label must also clearly state that the product has been conditionally licensed and

that additional data is required to fully evaluate its efficacy and safety.

The manufacturer must continue to collect data on the safety

and efficacy of the product and submit it to the CVB for review.

The CVB may require additional studies or data to be submitted before

granting full licensure.

To obtain full licensure for a veterinary biologic product that has been granted conditional licensure by the

CVB, the manufacturer must meet the follow-up study requirements specified in the conditional license and submit additional data to the

CVB demonstrating the safety and efficacy of the product, which may include results from additional studies, post-marketing surveillance

data and other relevant information.

In addition to granting licenses,

the CVB is responsible for establishing and enforcing manufacturing standards for veterinary biologics, including requirements for facilities,

equipment, and procedures.

The CVB conducts inspections of manufacturing facilities to ensure compliance with these standards and may

revoke licenses for manufacturers that fail to comply.

The CVB also monitors veterinary biologics after they are marketed to detect and

respond to any safety or efficacy issues that may arise.

The CVB may require manufacturers to conduct post-marketing surveillance studies

or to report adverse events associated with their products.

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

Although we do not currently

have any drugs on the market, if we begin commercializing our current or future product candidates, we will be subject to additional healthcare

statutory and regulatory requirements and enforcement by the federal government and the states and foreign governments in which we conduct

our business.

Healthcare providers, including physicians, play a primary role in the recommendation and prescription of any current or

future product candidates for which we obtain marketing approval.

Our future arrangements with healthcare providers, as well as third-party

payors and other customers, may expose us to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain

the business or financial arrangements and relationships through which we market, sell and distribute our current or future product candidates

for which we obtain marketing approval.

Restrictions under applicable federal and state healthcare laws and regulations, include the following:

Anti-Kickback Statute.

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 under federal and state healthcare programs such as Medicare,

Medicaid and TRICARE.

False Claims Act.

False Claims Act imposes criminal and civil penalties, including through 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.

In addition, manufacturers

can be held liable under the False Claims Act even when they do not submit claims directly to government payors if they are deemed to

“cause” the submission of false or fraudulent claims.

The government may assert that a claim including items and services

resulting from a violation of the federal Anti-Kickback Statute constitutes a false of fraudulent claim for purposes of the False Claims

Analogous State Laws.

state laws and regulations, such as state anti-kickback and false claims laws that may apply to sales or marketing arrangements and claims

involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers;

state laws require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the

relevant compliance guidance promulgated by the federal government in addition to requiring drug manufacturers to report information related

to payments to physicians and other health care providers or marketing expenditures.

Healthcare Reform

The United States and

many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system.

Changes in regulations,

statutes or the interpretation of existing regulations could impact our business in the future by requiring, for example, (i) changes

to our manufacturing arrangements, (ii) additions or modifications to product labeling, (iii) the recall or discontinuation

of our products or (iv) additional record-keeping requirements.

If any such changes were to be imposed, they could adversely affect

the operation of our business.

In the United States,

there have been and continue to be a number of legislative initiatives to contain healthcare costs.

For example, in March 2010, the

Affordable Care Act, or the ACA, was passed, which substantially changed the way healthcare is financed by both governmental and private

insurers, and significantly impacted the U.S.

pharmaceutical industry.

The ACA, among other things, subjects biological products

to potential competition by lower-cost biosimilars, addresses a new methodology by which rebates owed by manufacturers under the Medicaid

Drug Rebate Program are calculated for drugs that are inhaled, infused, instilled, implanted or injected, increases the minimum Medicaid

rebates owed by manufacturers under the Medicaid Drug Rebate Program and extends the rebate program to individuals enrolled in Medicaid

managed care organizations, establishes annual fees and taxes on manufacturers of certain branded prescription drugs, and creates a new

Medicare Part D coverage gap discount program, in which manufacturers must agree to offer 70% (increased pursuant to the Bipartisan

Budget Act of 2018, effective as of 2019) point-of-sale discounts off negotiated prices of applicable brand drugs

to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered

under Medicare Part D.

There has been increasing

legislative and enforcement interest in the United States with respect to specialty drug pricing practices.

Specifically, there

have been several recent U.S.

Congressional inquiries and proposed federal and state legislation designed to, among other things,

bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing

and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.

In May 2019, CMS issued a

final rule to allow Medicare Advantage Plans the option of using step therapy, a type of prior authorization, for Part B drugs beginning

January 1, 2020.

This final rule codified CMS’s policy change that was effective January 1, 2019.

On September 24, 2020,

the FDA released a final rule effective November 30, 2020, providing guidance for states to build and submit importation plans for

drugs from Canada.

The Inflation Reduction Act

(“IRA”) was passed into law on August 16, 2022.

The drug pricing reform section of the IRA represents a sweeping change

with respect to how the Medicare program will pay for prescription drugs in the future.

The IRA drug pricing provisions will be phased

Medicare will negotiate a “maximum fair price” directly with manufacturers for the most expensive drugs covered

under Medicare Part B and Medicare Part D.

In addition, additional rebates will be imposed on manufacturers related to

certain Medicare Part B and D covered drugs to the extent their costs are rising faster than inflation.

In addition, the Part D

benefit will be restructured and in 2025 the existing coverage gap discount program, in which manufacturers must agree to offer 70% (increased

pursuant to the Bipartisan Budget Act of 2018, effective as of 2019) point-of-sale discounts off negotiated prices of applicable

brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to

be covered under Medicare Part D will sunset.

The program will be replaced by a new Part D rebate program pursuant to which

manufacturers of certain drugs will pay a rebate of 10 percent off the negotiated price for applicable drugs (branded drugs and biologics

manufactured by companies that have Part D discount agreements) after the deductible is satisfied through the catastrophic phase

of the benefit.

In the catastrophic phase, manufacturers will provide a 20 percent discount off negotiated price.

At the state level, individual

states are increasingly aggressive in passing legislation and implementing regulations designed to designed to create prescription drug

price transparency and in some instances control pharmaceutical and biological product pricing or set maximum reimbursement for certain

drug products, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

In addition, regional health

care authorities and individual hospitals are increasingly using bidding procedures to determine what pharmaceutical products and which

suppliers will be included in their prescription drug and other health care programs.

These measures could reduce the ultimate demand

for our products, once approved, or put pressure on our product pricing.

There have been, and likely

will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availability

of healthcare and containing or lowering the cost of healthcare.

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.

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.

legislative and regulatory frameworks exist in other countries, where foreign authorities regulate drug approval, reimbursement and healthcare

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.

Privacy and Data Protection Laws

federal Health Insurance Portability and Accountability Act of 1996 (“HIPPA”) imposes criminal and civil liability

for executing a scheme to defraud any healthcare benefit program, or 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;

similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent

to violate it in order to have committed a violation.

as amended by the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”) and its

implementing regulations, which also imposes obligations on certain covered entity healthcare providers, health plans, and healthcare

clearinghouses as well as their business associates that perform certain services involving the use or disclosure of individually identifiable

health information, including mandatory contractual terms, with respect to safeguarding the privacy, security and transmission of individually

identifiable health information.

HITECH also created new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties

directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions

in federal courts to enforce the federal HIPAA laws and seek attorneys’ fees and costs associated with pursuing federal civil actions.

EU General Data Protection Regulation (“GDPR”) also confers a private right of action on data subjects and consumer associations

to lodge complaints with supervisory authorities, seek judicial remedies, and obtain compensation for damages resulting from violations

In addition, the GDPR includes restrictions on cross-border data transfers.

The GDPR may increase our responsibility

and liability in relation to personal data that we process where such processing is subject to the GDPR, and we may be required to put

in place additional mechanisms to ensure compliance with the GDPR, including as implemented by individual countries.

Compliance with the

GDPR is a rigorous and time-intensive process that may increase our cost of doing business or require us to change our business practices,

and despite those efforts, there is a risk that we may be subject to fines and penalties, litigation, and reputational harm in connection

with our European activities.

Further, the United Kingdom’s decision to leave the European Union, referred to as Brexit, has created

uncertainty with regard to data protection regulation in the United Kingdom.

In particular, it is unclear how data transfers to and from

the United Kingdom will be regulated now that the United Kingdom has left the European Union.

recently enacted and has proposed companion regulations to the California Consumer Privacy Act (“CCPA”) which went into effect

January 1, 2020.

The CCPA creates new individual privacy rights for California consumers (as defined in the law) and places increased

privacy and security obligations on entities handling personal data of consumers or households.

The CCPA requires covered companies to

provide certain disclosures to consumers about its data collection, use and sharing practices, and to provide affected California residents

with ways to opt-out of certain sales or transfers of personal information.

As of March 28, 2020, the California State

Attorney General has proposed varying versions of companion draft regulations which are not yet finalized.

Despite the delay in adopting

regulations, the California State Attorney General will commence enforcement actions against violators beginning July 1, 2020.

there is currently an exception for protected health information that is subject to HIPAA and clinical trial regulations, other records

and information we maintain on our customers may be subject to the CCPA.

Where state laws are more protective than HIPAA, we must

comply with the state laws we are subject to, in addition to HIPAA.

In certain cases, it may be necessary to modify our planned operations

and procedures to comply with these more stringent state laws.

Not only may some of these state laws impose fines and penalties upon violators,

but also some, unlike HIPAA, may afford private rights of action to individuals who believe their personal information has been misused.

In addition, state laws are changing rapidly, and there is discussion of a new federal privacy law or federal breach notification law,

to which we may be subject.

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.

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

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

Outside the United States, privacy and data protection laws regulate the processing of personal information, including health-related

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.

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.

State Privacy Laws.

states have enacted comprehensive privacy laws that regulate the collection and use of personal information.

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, properties

and products are subject to a variety of U.S.

and foreign environmental laws and regulations governing, among other things, use of

manufacturing components containing substances below established threshold, air emissions, wastewater discharges, management and disposal

of hazardous and non-hazardous materials and waste and remediation of releases of hazardous materials.

Our operations involve the use

of hazardous and flammable materials, including chemicals and biological and radioactive materials.

Our operations also produce hazardous

waste products.

We generally contract with third parties for the disposal of these materials and wastes.

The use of hazardous substances

is regulated and monitored by various environmental regulatory authorities such as the EPA.

As such, we are subject to national,

state and local laws, regulations and directives pertaining to hazardous substances, pollution and protection of the environment, health

and safety, which govern, among other things, emissions to the air, discharges onto land or waters, the maintenance of safe conditions

in the workplace, and the generation, handling, storage, transportation, treatment and disposal of waste materials.

These laws include,

without limitation, the Comprehensive Environmental Response, Compensation, and Liability Act, the Federal Facilities Compliance Act,

the Hazardous Materials Transportation Act, and the Resource Conservation and Recovery Act.

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 regulations that govern

regulatory approvals, pricing and reimbursement for new drugs vary widely from country to country.

Some countries require approval of

the sale price of a drug before it can be marketed.

In many countries, the pricing review period begins after marketing approval is granted.

In some foreign markets, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval

As a result, we might obtain marketing approval for a product candidate in a particular country, but then be subject to price

regulations that delay our commercial launch of the product candidate, possibly for lengthy time periods.

Our ability to commercialize

any current or future product candidates successfully also will depend in part on the extent to which coverage and reimbursement for these

current or future product candidates and related treatments will be available from government authorities, private health insurers and

other organizations.

Government authorities and other third-party payors, such as private health insurers and health maintenance organizations,

decide which medications they will pay for and establish reimbursement levels.

Factors payors consider in determining reimbursement are

based on whether the product is:

● a covered benefit under its health plan;

● safe, effective and medically necessary;

● appropriate for the specific patient;

● cost-effective;

● neither experimental nor investigational.

A primary trend in the U.S.

industry and elsewhere is cost containment.

Government authorities and other third-party payors have attempted to control costs by limiting

coverage and the amount of reimbursement for particular drugs.

Increasingly, third-party payors are requiring that drug companies provide

them with predetermined discounts from list prices and are challenging the prices charged for drugs.

Reimbursement may impact the demand

for, or the price of, any product candidate for which we obtain marketing approval.

There may be significant delays

in obtaining reimbursement for newly approved drugs, and coverage may be more limited than the purposes for which the drug is approved

by the FDA or similar regulatory authorities outside the United States.

Moreover, eligibility for reimbursement does not imply

that any drug will be paid for in all cases or at a rate that covers our costs, including research, development, manufacture, sale and

distribution.

Interim reimbursement levels for new drugs, if applicable, may also not be sufficient to cover our costs and may not be

made permanent.

Reimbursement rates may vary according to the use of the drug and the clinical setting in which it is used, may be based

on reimbursement levels already set for lower cost drugs and may be incorporated into existing payments for other services.

for drugs may be reduced by mandatory discounts or rebates required by government healthcare programs or private payors and by any future

relaxation of laws that presently restrict imports of drugs from countries where they may be sold at lower prices than in the United States.

the United States, the principal decisions about coverage and reimbursement of new medicines under the Medicare program are typically

made by the Centers for Medicare & Medicaid Services (“CMS”) an agency within the U.S.

Department of Health

and Human Services, or HHS.

CMS decides whether and to what extent a new medicine will be covered and reimbursed under Medicare.

Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies.

Among other matters, U.S.

foreign anti-corruption, anti-money laundering, export control, sanctions, and other trade laws and regulations, which are collectively

referred to as Trade Laws, prohibit companies and their employees, agents, clinical research organizations, legal counsel, accountants,

consultants, contractors, and other partners from authorizing, promising, offering, providing, soliciting, or receiving directly or indirectly,

corrupt or improper payments or anything else of value to or from recipients in the public or private sector.

Violations of Trade Laws

can result in substantial criminal fines and civil penalties, imprisonment, the loss of trade privileges, debarment, tax reassessments,

breach of contract and fraud litigation, reputational harm, and other consequences.

We have, or may have in the future, direct or indirect

interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations.

We plan to engage third parties for clinical trials and/or to obtain necessary permits, licenses, patent registrations, and other regulatory

approvals and we can be held liable for the corrupt or other illegal activities of our personnel, agents, or partners, even if we do not

explicitly authorize or have prior knowledge of such activities.

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.

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.

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

While we are not aware of

any competing adjuvant therapy for Osteosarcoma to be tested in children that is further along in the development process than OST-HER2,

there are a large number of companies developing or marketing treatments for rare diseases and cancers, including many major pharmaceutical

and biotechnology companies.

We may face competition from other product candidates in development for these indications, including product

candidates in development from AstraZeneca, Y-mAbs Therapeutics and MD Anderson Cancer Center, among others.

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 28, 2025, we

had four full-time employees and one part-time employee.

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

3 unchanged sentences

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.

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

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.

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 “Purchase Agreement”) with certain institutional and accredited investors (collectively,

the “PIPE investors”), substantially all of whom were our existing stockholders, pursuant to which we agreed to issue and

sell to the PIPE investors immediately separable units (the “Units”), with each Unit being comprised of (i) one share of Series

A Senior Convertible Preferred Stock, par value $0.001 per share (the “Series A Preferred Stock”), and (ii) a warrant to purchase

one share of common stock (each, a “Series A Warrant” and such shares, the “Warrant Shares”), at a price per Unit

of $4.00, for aggregate gross proceeds of not less than $6 million and not more than $10 million (the “Private Placement”).

At two closings occurring on December 31, 2024 and January 14, 2025, we issued to the PIPE investors an aggregate of (i) 1,775,750 shares

of Series A Preferred Stock and (ii) Series A Warrants initially exercisable into 1,775,750 shares of common stock.

The gross proceeds

from the Private Placement, before deducting transaction fees and other estimated Private Placement expenses, were approximately $7,103,000.

The Purchase Agreement requires us to seek stockholder approval for any transactions contemplated by the Purchase Agreement and the related

documents for which the rules of the NYSE American require stockholder approval (“Stockholder Approval”) and to hold a special

meeting of stockholders for the purpose of obtaining Stockholder Approval not later than April 10, 2025.

In the event Stockholder Approval

is not obtained at the first meeting, we are required to call a meeting every four months seeking Stockholder Approval until Stockholder

Approval is obtained.

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”).

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

Brookline Capital Markets,

a division of Arcadia Securities, LLC (“Brookline”), acted as exclusive placement agent for the issuance and sale of the securities

in the Private Placement.

Pursuant to the terms of a letter agreement, dated December 27, 2024, between us and Brookline (the “Placement

Agency Agreement”), we agreed to pay Brookline an aggregate cash fee (the “Cash Fee”) equal to (i) 7% of the gross proceeds

received by us from the sale of the securities in the Private Placement to PIPE investors other than certain PIPE investors identified

on a schedule thereto (“Reduced Fee Purchasers”), plus (ii) 3% of the gross proceeds received by us from the sale of the securities

in the Private Placement to Reduced Fee Purchasers, plus expenses;

provided that Ceros Financial Services, Inc., Brookline’s selected

dealer for the Private Placement (“Ceros”), is entitled to 33.3% of the Cash Fee.

In addition, we agreed to

pay Brookline or its designees a fee in the form of warrants to purchase shares of common stock (the “Agent Warrants”).

Agent Warrants are initially exercisable into a number of shares of common stock equal to (i) 7% of the number of shares of common stock

initially issuable pursuant to the shares of Series A Preferred Stock issued to PIPE investors, other than Reduced Fee Purchasers in the

Private Placement, plus (ii) 3% of the number of shares of common stock initially issuable pursuant to the shares of Series A Preferred

Stock issued to Reduced Fee Purchasers in the Private Placement;

provided that Ceros or its designee is entitled to 33.3% of the Agent

At two closings occurring on December 31, 2024 and January 14, 2025, (i) Brookline received an aggregate cash fee of $159,685

and the right to receive Agent Warrants initially exercisable for an aggregate of 39,918 shares of common stock, and (ii) Ceros received

an aggregate cash fee of $79,723 and the right to receive Agent Warrants initially exercisable for an aggregate of 19,930 shares of common

On January 28, 2025, we entered

into the HER2 Purchase Agreement with Ayala, pursuant to which we agreed, subject to the terms and conditions set forth therein, to acquire

from Ayala the HER2 Assets.

The HER2 Assets include two IND filings with the FDA:

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

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

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;

ADXS-504 for prostate cancer.

The closing of the transaction, which we expect to occur in the second quarter of 2025, is subject to assignment

of the Penn License, execution and delivery of a patent assignment agreement, a termination of license agreement, a lock-up agreement

and a registration rights agreement, the approval of the transaction by Ayala stockholders and other customary closing conditions.

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

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.

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.

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

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

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.

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%

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

5 unchanged sentences

in August 2024 and our common stock is currently listed on NYSE American under the symbol “OSTX.”

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.

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.

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.

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business