What changed in this filing

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Item 2. Management’s Discussion and Analysis

2025-11-14 compared with 2025-08-18 · 328 added, 263 removed, 438 unchanged (57% of the section changed)

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and analysis of the financial condition and results of operations of OS Therapies Incorporated (“OS Therapies,” the “Company,”

“we,” “our” or “us”) should be read in conjunction with the financial statements and notes thereto

appearing in Part I, Item 1 of this report.

In the following discussions, most percentages and dollar amounts have been rounded to aid

presentation, and, accordingly, all amounts are approximations.

“we,” “our” or “us”) should be read in conjunction with the consolidated financial statements and

notes thereto appearing in Part I, Item 1 of this report.

In the following discussions, most percentages and dollar amounts have been

rounded to aid presentation, and, accordingly, all amounts are approximations.

Cautionary Note Regarding Forward-Looking Statements

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a cellular immune response against the cancer antigen HER2.

In 2021, we opened a clinical study to produce data for the U.S.

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 June 2025, we participated in a Type D meeting with the FDA and subsequently

received positive written feedback regarding the design and endpoints of our Phase IIb trial of OST-HER2 to support a potential Biologics

License Application (BLA).

Based on this feedback, we have submitted a Breakthrough Therapy Designation request and, subject to continued

positive regulatory guidance, plan to submit a BLA for OST-HER2 following our End of Phase 2 meeting with the FDA, anticipated in the

third quarter of 2025.

Upon success in gaining regulatory approval from the FDA with OST-HER2 in Osteosarcoma, we intend to evaluate

OST-HER2’s potential use, both alone and in combination with HER2 targeting antibodies such as Herceptin®, in other solid tumors

including breast, esophageal and lung cancers.

OST-HER2 has potential uses in both the prevention of metastases in solid tumors, and therapeutically

against HER2-expressing solid tumors treated with HER targeting antibodies.

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 <

OST-HER2 was observed to be well-tolerated in the study.

We believe the results, combined with the product’s safety profile

and unmet clinical need, support the potential for regulatory approval from the FDA.

We have conducted regulatory

meetings with the FDA, the United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), and the European Medicines Agency

Representatives from these agencies indicated that overall survival, when supported by biomarker data, may be considered an appropriate

clinical endpoint to support conditional marketing authorization.

We are currently analyzing patient samples from our Phase IIb trial

to assess potential correlations between clinical outcomes and immune system biomarker activation, with results expected in November 2025.

We expect to submit a conditional Marketing Authorization Application (MAA) to the MHRA in December 2025, a Biologics License Application

under the FDA’s Accelerated Approval Program in January 2026, and an MAA to the EMA in the first quarter of 2026.

If approved, we

would become eligible to receive a Priority Review Voucher from the FDA.

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 OST-Tunable

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PIPE Financing

December 24, 2024, we entered into a Securities Purchase Agreement (the “PIPE Purchase Agreement”) with certain institutional

and accredited investors (collectively, the “Purchasers”), substantially all of whom were existing

stockholders of our company, pursuant to which we agreed to issue and sell to the Purchasers immediately separable units (the “Units”),

with each Unit being comprised of (i) one share of Series A s enior c onvertible

p referred s tock

(“Series A Preferred Stock”) and (ii) a warrant to purchase one share

On December 24, 2024, we

entered into a Securities Purchase Agreement (the “PIPE Purchase Agreement”) with certain institutional and accredited investors

(collectively, the “Purchasers”), substantially all of whom were existing stockholders of our company, pursuant to which we

agreed to issue and sell to the Purchasers immediately separable units (the “Units”), with each Unit being comprised of (i)

one share of Series A senior convertible preferred stock (“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,

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The gross proceeds from the PIPE

Financing , before deducting transaction fees and other estimated PIPE

Financing expenses, were approximately $7,103,000.

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

and sale of the securities in the PIPE Financing.

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 PIPE Financing to Purchasers other than certain Purchasers 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 PIPE Financing to Reduced Fee Purchasers, plus expenses;

provided that Ceros Financial Services, Inc.,

Brookline’s selected dealer for the PIPE Financing (“Ceros”) , is

entitled to up to 33.3% of the Cash Fee.

addition, we agreed to pay Brookline or its designee a fee in the form

of warrants to purchase shares of common stock (the “Agent Warrants”).

The 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 Purchasers other than Reduced Fee Purchasers in the PIPE Financing plus (ii) 3% of the number of shares

of common stock initially issuable pursuant to the shares of Series A Preferred Stock issued to the Reduced

Fee Purchasers in the PIPE Financing;

Financing, before deducting transaction fees and other estimated PIPE Financing expenses, were approximately $7,103,000.

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 PIPE Financing.

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 PIPE Financing to Purchasers other than certain Purchasers 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

PIPE Financing to Reduced Fee Purchasers, plus expenses;

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

for the PIPE Financing (“Ceros”), is entitled to up to 33.3% of the Cash Fee.

In addition, we agreed to

pay Brookline or its designee 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 Purchasers other than Reduced Fee Purchasers in the PIPE

Financing plus (ii) 3% of the number of shares of common stock initially issuable pursuant to the shares of Series A Preferred Stock issued

to the Reduced Fee Purchasers in the PIPE Financing;

provided that, Ceros is entitled to up to 33.3% of the Agent Warrants.

The terms of the Agent Warrants

are substantially similar to the terms of the Series A Warrants.

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 stock.

of the Agent Warrants are substantially similar to the terms of the Series A Warrants.

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 stock.

The PIPE Purchase Agreement

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Warrant Shares”).

Once we obtain stockholder approval in accordance with NYSE American LLC Company Guide Section 713, we will subsequently

issue to Ayala the remaining 444,041 shares of common stock (the “Ayala Additional Consideration Shares”), except that, if

at that time, the number of shares of common stock beneficially owned by Ayala would exceed 9.99% of the number of shares of our common

stock then outstanding, Ayala has the right to require us to issue, in lieu of such shares, a warrant to purchase 444,041 on substantially

the same terms of the Ayala Warrant.

On October 21, 2025, we obtained stockholder approval in accordance with NYSE American LLC Company Guide Section

713 and subsequently issued to Ayala the remaining 444,041 shares of common stock (the “Ayala Additional Consideration Shares”).

Ayala entered into a lock-up

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the closing of the transaction.

Warrant Exercise Inducement

and Exchange Offer

Warrant Exercise Inducement and Exchange

On July 11, 2025, we completed

a final closing of a warrant exercise inducement and exchange offer (the “Offering”).

The Offering was made to holders (the

“Holders”) of certain of our existing warrants to purchase shares of our common stock, having a then current exercise price

of $1.12 per share, originally issued to the Holders pursuant to the PIPE Purchase Agreement (the “Existing Warrants”), during

the period beginning on June 20, 2025 and ending at 5:00 p.m., Eastern time, on July 10, 2025 (the “Inducement Period”).

During the Inducement Period,

a final closing of a warrant exercise inducement and exchange offer (the “First Offering”).

On September 2, 2025, we closed

on a second warrant exercise inducement and exchange offer (the “Second Offering” and, together with the First Offering, the

“Offerings”).

The First Offering and Second Offering were made to holders (the “Holders”) of certain of our existing

warrants to purchase shares of our common stock, having a then current exercise price of $1.12 per share, originally issued to the Holders

pursuant to the PIPE Purchase Agreement (the “Existing Warrants”), during the period beginning on June 20, 2025 and ending

on July 10, 2025, with respect to the First Offering (the “First Inducement Period”), and during the period beginning on August

29, 2025 and ending on September 1, 2025, with respect to the Second Offering (the “Second Inducement Period” and, together

with the First Inducement Period, the “Inducement Periods”).

During the Inducement Periods,

we entered into inducement offer letter agreements (the “Inducement Letters”) with the Holders of Existing Warrants, pursuant

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The New Warrants are immediately exercisable from the date of issuance and have a term of exercise of five years from such date.

Pursuant to the terms of

the Inducement Letters, if the exercise of any Existing Warrant by a Holder would have resulted in such Holder exceeding the beneficial

ownership limitation contained in the Existing Warrants, the Holder agreed to pre-fund the exercise of its Existing Warrants for cash

at $1.119 per share.

Upon such pre-funding, the exercise price of the Holder’s Existing Warrants was reduced to $0.001 per share

(the “Remaining Exercise Price”), and such Existing Warrants became exercisable for our common stock solely at the Remaining

Exercise Price.

A Holder pre-funded the exercise of 937,500 of its Existing Warrants and agreed to receive 937,500 prepaid shares of common

stock that will be issued in the future.

We engaged an SEC registered

broker dealer and FINRA member (the “Solicitation Agent”) to act as our exclusive warrant solicitation agent in connection

with the Offering and agreed to pay the Solicitation Agent a cash fee equal to 5.0% of the total gross cash proceeds received from the

exercise by the Holders of their Existing Warrants during the Inducement Period.

We also agreed to pay the Solicitation Agent up to $15,000

for its reasonable legal and other expenses.

with the Offerings and agreed to pay the Solicitation Agent a cash fee equal to (i) 5.0% of the total gross cash proceeds received from

the exercise by the Holders of their Existing Warrants during the First Inducement Period and (ii) 1.5% of the total gross cash proceeds

received from the exercise by the Holders of their Existing Warrants during the Second Inducement Period.

We also agreed to pay the Solicitation

Agent up to $15,000 for its legal and other expenses.

The gross proceeds to us

from the Offering, before deducting transaction fees and other estimated Offering expenses, were approximately $4,216,794.

use the net proceeds 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, advance strategic alternatives

for our OS Animal Health subsidiary, close out and report on our OST-504 (previously ADXS-504) prostate cancer study, initiate AI-driven

next-generation tADC product candidate modeling and for general corporate purposes.

from the Offerings, before deducting transaction fees and other estimated Offering expenses, were approximately $6,398,358.

the net proceeds from the 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, advance strategic

alternatives for our OS Animal Health subsidiary, close out and report on our OST-504 (previously ADXS-504) prostate cancer study, initiate

AI-driven next-generation tADC product candidate modeling and for general corporate purposes.

We also agreed to file a

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on Form S-3) (the “Resale Registration Statement”) providing for the resale of the shares of common stock issued or issuable

upon exercise of the New Warrants, within 30 calendar days of the final closing, and to use commercially reasonable efforts to have such

Resale Registration Statement declared effective by the SEC within 60 calendar days (or within 90 calendar days in case of “full

review” of the Resale Registration Statement by the SEC) following the initial filing of such Resale Registration Statement and

to keep the Resale Registration Statement effective at all times until the earlier of (i) the time no holder of the New Warrants owns

any New Warrants or New Warrant Shares and (ii) the Delegend Date (as defined in the Inducement Letters).

upon exercise of the New Warrants, within 30 calendar days of July 11, 2025, with respect to the First Offering, and September 2, 2025,

with respect to the Second Offering, and to use commercially reasonable efforts to have such Resale Registration Statement declared effective

by the SEC within 60 calendar days (or within 90 calendar days in case of “full review” of the Resale Registration Statement

by the SEC) following the initial filing of such Resale Registration Statement and to keep the Resale Registration Statement effective

at all times until the earlier of (i) the time no holder of the New Warrants owns any New Warrants or New Warrant Shares and (ii) the

Delegend Date (as defined in the Inducement Letters).

ATM Equity Offering Program

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, 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 the date of this filing, we have sold

an aggregate of 189,600 shares of our common stock for aggregate gross proceeds of $384,888 pursuant to the Sales Agreement.

Critical Accounting Policies and Estimates

Our financial statements

are prepared in accordance with generally accepted accounting principles in the United States (“GAAP”).

The preparation

of our financial statements and related disclosures requires us to make estimates and judgments that affect the reported amounts of assets,

liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our financial statements.

We base our estimates

on historical experience, known trends and events and various other factors that we believe are reasonable under the circumstances, the

results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent

from other sources.

Our consolidated financial

statements are prepared in accordance with generally accepted accounting principles in the United States (“GAAP”).

preparation of our consolidated financial statements and related disclosures requires us to make estimates and judgments that affect the

reported amounts of assets, liabilities, costs and expenses, and the disclosure of contingent assets and liabilities in our consolidated

financial statements.

We base our estimates on historical experience, known trends and events and various other factors that we believe

are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and

liabilities that are not readily apparent from other sources.

We evaluate our estimates and assumptions on an ongoing basis.

Our actual results may differ from these estimates

under different assumptions or conditions.

results may differ from these estimates under different assumptions or conditions.

Critical accounting policies

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While our significant accounting policies are described in more detail

in Note 2 to our financial statements appearing elsewhere in this annual report, we believe that the following accounting policies

are those most critical to the judgments and estimates used in the preparation of our financial statements.

in Note 2 to our consolidated financial statements appearing elsewhere in this annual report, we believe that the following accounting

policies are those most critical to the judgments and estimates used in the preparation of our consolidated financial statements.

Warrant Liability

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instruments, including whether such instruments should be recorded as liabilities or as equity, is re-assessed at the end of each reporting

The Series A Warrants issued in connection with the Purchase Agreement

are recognized as a derivative liability in accordance with ASC 815.

We recognize the warrant instruments as a liability at fair value

and adjust the instruments to fair value at each reporting period.

The liability is subject to re-measurement at each balance sheet date

until exercised or reclassified, and any change in fair value is recognized in our consolidated statements of operations.

The fair value

of the Series A Warrants was measured using a Binomial simulation model.

The determination of the fair value of the warrant liability

may be subject to change as more current information becomes available, and accordingly, the actual results could differ significantly.

The derivative warrant liability is classified as non-current liabilities as their liquidation is not reasonably expected to require the

use of current assets or require the creation of current liabilities.

The Series A Warrants issued

in connection with the Purchase Agreement are recognized as a derivative liability in accordance with ASC 815.

We recognize the warrant

instruments as a liability at fair value and adjust the instruments to fair value at each reporting period.

The liability is subject to

re-measurement at each balance sheet date until exercised or reclassified, and any change in fair value is recognized in our consolidated

statements of operations.

The fair value of the Series A Warrants was measured using a Binomial simulation model.

The determination of

the fair value of the warrant liability may be subject to change as more current information becomes available, and accordingly, the actual

results could differ significantly.

The derivative warrant liability is classified as non-current liabilities as their liquidation is

not reasonably expected to require the use of current assets or require the creation of current liabilities.

Components of Our Results of Operations

did not recognize revenues for the six months ended June 30, 2025 and 2024.

did not recognize revenues for the nine months ended September 30, 2025 and 2024.

Operating Expenses.

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The cumulative

accrued dividend as of June 30, 2025 and December 31, 2024 were $375,000 and $375,000, respectively.

The Series A preferred stock

was converted into common stock on a 1:1 basis in February 2024, and the last coupon dividend was issued in the quarter ended March 31,

accrued dividend as of September 30, 2025 and December 31, 2024 were $375,000 and $375,000, respectively.

The Series A preferred

stock was converted into common stock on a 1:1 basis in February 2024, and the last coupon dividend was issued in the quarter ended

March 31, 2024.

Income Taxes.

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the deferred tax assets due to the uncertainty of realizing the benefits of the net deferred tax asset.

Our issuances of common stock have resulted in ownership changes as

defined by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”);

however, we have not conducted

a Section 382 study to date.

It is likely that a future analysis may result in the conclusion that a substantial portion, or perhaps

substantially all, of our NOL carryforwards and R&D tax credit carryforwards will expire due to the limitations of Sections 382 and

383 of the Code.

As a result, the utilization of the carryforwards may be limited, and a portion of the carryforwards may expire unused.

Our issuances of common stock

have resulted in ownership changes as defined by Section 382 of the Internal Revenue Code of 1986, as amended (the “Code”);

however, we have not conducted a Section 382 study to date.

It is likely that a future analysis may result in the conclusion that

a substantial portion, or perhaps substantially all, of our NOL carryforwards and R&D tax credit carryforwards will expire due to

the limitations of Sections 382 and 383 of the Code.

As a result, the utilization of the carryforwards may be limited, and a portion of

the carryforwards may expire unused.

We are subject to U.S.

federal tax examinations by tax authorities for the year 2021 due to the fact that NOL carryforwards exist

going back to 2019 that may be utilized on a current or future year tax return.

federal tax examinations by tax authorities for the year 2021 due to

the fact that NOL carryforwards exist going back to 2019 that may be utilized on a current or future year tax return.

Deferred Offering Costs.

Deferred offering costs consisted of legal, accounting, printing and

filing fees that we capitalized, which were offset against the gross proceeds from our initial public offering.

Deferred offering costs consisted of legal, accounting, printing and filing fees that we capitalized, which were offset against

the gross proceeds from our initial public offering.

Results of Operations

Three and Six Months Ended June 30, 2025

Compared to Three and Six Months Ended June 30, 2024

The following table summarizes our results of operations for the three

and six months ended June 30, 2025 and 2024:

Three and Nine Months Ended September 30,

2025 Compared to Three and Nine Months Ended September 30, 2024

The following table summarizes

our results of operations for the three and nine months ended September 30, 2025 and 2024:

September 30,

OPERATING EXPENSES

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Loss from Operations

(16,717,809 )

OTHER INCOME/EXPENSE

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TOTAL OTHER INCOME/EXPENSE

(15,293,011 )

Research and Development

Research and development expenses were approximately $3.8 million

for the six months ended June 30, 2025 compared to approximately $0.8 million for the six months ended June 30, 2024.

This increase

was primarily due to an increase in vendor expenses associated with our Phase IIb clinical trial, as we compile data to submit to

various governmental agencies, and a decrease in vendor expenses associated with out OST-tADC platform technology.

Research and development expenses were approximately $7.6 million for the nine months ended September 30, 2025

compared to approximately $2.0 million for the nine months ended September 30, 2024.

This increase was primarily due to an increase

in vendor expenses associated with our pursuit for FDA approval on our Phase IIb clinical trial, as we compile data to submit to

various governmental agencies, and a decrease in vendor expenses associated with our OST-tADC platform technology.

Research and development

expenses were approximately $2.5 million for the three months ended June 30, 2025 compared to approximately $0.4 million for

the three months ended June 30, 2024.

expenses were approximately $3.8 million for the three months ended September 30, 2025 compared to approximately $1.2 million

for the three months ended September 30, 2024.

This increase was primarily due to an increase in vendor expenses associated with our Phase IIb

clinical trial, as we compile data to submit to various governmental agencies, and a decrease in vendor expenses associated with out OST-tADC

clinical trial, as we compile data to submit to various governmental agencies, and a decrease in vendor expenses associated with our OST-tADC

platform technology.

The following table summarizes

our research and development expenses for the three and six months ended June 30, 2025 and 2024:

Three Months Ended June 30,

Six Months Ended June 30,

our research and development expenses for the three and nine months ended September 30, 2025 and 2024:

Three Months Ended

September 30,

Nine Months Ended

September 30,

(In thousands)

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Total research and development expenses

For the six months ended

June 30, 2025 and 2024, the direct research and development expenses related to OST-HER2 were primarily lab fees, vendor expenses and

staff payroll fees.

For the nine months ended

September 30, 2025 and 2024, the direct research and development expenses related to OST-HER2 were primarily lab fees, vendor expenses

and staff payroll fees.

In 2025, such expenses were primarily lab fees and related clinical support of approximately $1.0 million attributed

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OST-tADC related direct research and development expenses were approximately $0.0 million and $0.0 million for the

six months ended June 30, 2025 and 2024, respectively.

nine months ended September 30, 2025 and 2024, respectively.

For the three months ended

June 30, 2025 and 2024, the direct research and development expenses related to OST-HER2 were primarily lab fees, vendor expenses and

staff payroll fees.

September 30, 2025 and 2024, the direct research and development expenses related to OST-HER2 were primarily lab fees, vendor expenses

and staff payroll fees.

In 2025, such expenses were primarily lab fees and related clinical support of approximately $0.03 million attributed

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OST-tADC related

direct research and development expenses were approximately $0.0 million and $0.0 million for the three months ended June 30,

direct research and development expenses were approximately $0.0 million and $0.0 million for the three months ended September

30, 2025 and 2024, respectively.

General and Administrative

General and administrative expenses for the six months ended June 30, 2025 were approximately $6.0 million compared

to $0.7 million for the six months ended June 30, 2024.

These expenses were primarily attributed to marketing and investor relations

costs and advisory fees associated with the PIPE Financing and equity line of credit.

General and administrative expenses for the nine months ended September 30, 2025 were approximately $9.2 million

compared to $1.9 million for the nine months ended September 30, 2024.

These expenses were primarily attributed to marketing and

investor relations costs and advisory fees associated with the PIPE Financing and equity line of credit.

General and administrative

expenses for the three months ended June 30, 2025 were approximately $2.3 million compared to $0.4 million for the three months

ended June 30, 2024.

These expenses were primarily attributed to marketing and investor relations costs and advisory fees associated with

the PIPE Financing and equity line of credit.

expenses for the three months ended September 30, 2025 were approximately $3.1 million compared to $1.2 million for the three

months ended September 30, 2024.

These expenses were primarily attributed to marketing and investor relations costs and advisory fees

associated with the PIPE Financing and equity line of credit.

Interest Expense.

expense for the six months ended June 30, 2025 was approximately $0.0 million compared to $1.6 million for the six months ended June 30,

expense for the nine months ended September 30, 2025 was approximately $0.0 million compared to $2.0 million for the nine months ended

September 30, 2024.

Interest expense for the

three months ended June 30, 2025 was approximately $0.0 million compared to $0.8 million for the three months ended June 30, 2024.

three months ended September 30, 2025 was approximately $0.0 million compared to $0.4 million for the three months ended September 30,

Change in Fair Value

The Series A preferred stock coupon dividend requirement of $31,250

for the six months ended June 30, 2024 represents an expense that terminated during the period ended March 31, 2024 upon the conversion

of our old Series A preferred shares into shares of our common stock.

We issued Series A convertible preferred stock and detachable warrants

on December 31, 2024 and January 14, 2025.

The adjustment of the fair value of the warrant liability was $1.4 million and $0.0 million for

the six months ended June 30, 2025 and 2024, respectively.

The Series A preferred stock

coupon dividend requirement of $31,250 for the nine months ended September 30, 2024 represents an expense that terminated during the period

ended March 31, 2024 upon the conversion of our old Series A preferred shares into shares of our common stock.

We issued Series A convertible

preferred stock and detachable warrants on December 31, 2024 and January 14, 2025.

The adjustment of the fair value of the warrant liability

was $1.4 million and $0.0 million for the nine months ended September 30, 2025 and 2024, respectively.

Liquidity and Capital Resources

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on the successful development and eventual commercialization of our product candidates.

For the six months ended June 30, 2025 and 2024,

For the nine months ended September 30, 2025 and

2024, we reported a net loss of approximately $15.3 million and $5.9 million, respectively, and had an accumulated deficit of approximately

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losses for the foreseeable future.

For the three months ended June 30, 2025 and 2024, we reported a net loss of approximately $4.5 million

and $1.6 million, respectively.

As of June 30, 2025 and December 31, 2024, we had cash of approximately

For the three months ended September 30, 2025 and 2024, we reported a net loss of approximately $6.9

million and $2.9 million, respectively.

We have funded our operations to date primarily from the sale of our convertible notes

and Series A securities in our private placements and cash exercises of our warrants, as well as the sale of our common stock in our initial

public offering, which have provided total gross proceeds of $37.1 million as of June 30, 2025.

We believe that the net proceeds from

our private placements and initial public offering, together with our existing cash, will enable us to fund our operating expenses and

capital expenditure requirements for the next nine to 12 months.

The following table summarizes our sources and uses of cash for the

six months ended June 30, 2025 and 2024:

As of September 30, 2025

and December 31, 2024, we had cash of approximately $1.9 million and $5.5 million, respectively.

We have funded our operations to

date primarily from the sale of our convertible notes and Series A securities in our private placements and cash exercises of our warrants,

as well as the sale of our common stock in our initial public offering, which have provided total gross proceeds of $41.1 million as of

September 30, 2025.

We believe that the net proceeds from our private placements and initial public offering, together with our existing

cash, will enable us to fund our operating expenses and capital expenditure requirements for the next nine to twelve months.

The following table summarizes

our sources and uses of cash for the nine months ended September 30, 2025 and 2024:

September 30,

(In thousands)

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Operating Activities

During the six months ended June 30, 2025 and 2024, operating activities

used approximately $5.9 million and $1.5 million of cash, respectively, resulting from our net loss of approximately $8.4 million and

$3.0 million, respectively, offset by net non-cash charges of approximately $1.4 million and $1.1 million, respectively, partially offset

by net cash provided by changes in our operating assets and liabilities of approximately $1.2 million and $0.4 million, respectively.

During the nine months ended

September 30, 2025 and 2024, operating activities used approximately $10.5 million and $4.9 million of cash, respectively, resulting from

our net loss of approximately $15.3 million and $5.9 million, respectively, offset by net non-cash charges of approximately $2.6 million

and $1.4 million, respectively, partially offset by net cash provided by changes in our operating assets and liabilities of approximately

$2.1 million and ($0.4) million, respectively.

Net cash provided by changes

in our operating assets and liabilities for the six months ended June 30, 2025 and 2024 consisted primarily of an increase (decrease)

in our operating assets and liabilities for the nine months ended September 30, 2025 and 2024 consisted primarily of an increase (decrease)

in accounts payable of approximately $1.7 million and $(0.94) million, respectively, an increase in accrued interest of approximately

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Non-cash charges for the

six months ended June 30, 2025 and 2024 were primarily the result of the changes in the fair value of our warrant liability of $(1.4)

million and $0.0 million, respectively, combined with our common stock shares issued for service and our stock-based compensation of approximately

$2.7 million and $0.0 million, respectively.

Changes in accounts payable, accrued expenses and other current liabilities and prepaid expenses

and other current assets in all periods were generally due to growth in our business, the advancement of our research programs and the

timing of vendor invoicing and payments.

nine months ended September 30, 2025 and 2024 were primarily the result of the changes in the fair value of our warrant liability of $(1.4)

million and $0.0 million, respectively, combined with our common stock shares issued for services and our stock-based compensation of

approximately $3.3 million and $0.0 million, respectively.

Changes in accounts payable, accrued expenses and other current liabilities

and prepaid expenses and other current assets in all periods were generally due to growth in our business, the advancement of our research

programs and the timing of vendor invoicing and payments.

Investing Activities

During the six months ended June 30, 2025 and 2024, net cash used in

investing activities was approximately $0.4 million and $0.0 million, respectively.

During the nine months ended

September 30, 2025 and 2024, net cash used in investing activities was approximately $0.4 million and $0.0 million, respectively.

Financing Activities

For the six months ended June 30, 2025 and 2024, net cash provided

by financing activities was approximately $3.5 million and $1.6 million, respectively.

For the six months ended June 30, 2025, we saw

funds raised from our Series A securities offering of $1.1 million and our warrant inducement exercise offering of $2.5 million.

For the nine months ended

September 30, 2025 and 2024, net cash provided by financing activities was approximately $7.3 million and $6.7 million, respectively.

For the nine months ended September 30, 2025, we saw funds raised from our Series A securities offering of $1.1 million and our warrant

inducement exercise offering of $6.3 million.

Convertible Notes.

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of BlinkBio, in exchange for the entry into the license agreement.

On March 15, 2021, the principal and unpaid accrued interest

of $100,000 of the BlinkBio Convertible Note converted into 1,302,082 shares of our Series A preferred stock and then distributed

to BlinkBio stockholders.

The BlinkBio Convertible Note had a conversion capitalization ceiling of $19.2 million, which limited

the price a noteholder must pay in a convertible note-to-common stock conversion occurrence.

On February 9, 2024, the 1,302,082

shares of our Series A preferred stock were converted into 651,041 shares of common stock (on a post-split basis).

On March 15, 2021, the principal and unpaid accrued interest of

$100,000 of the BlinkBio Convertible Note converted into 1,302,082 shares of our Series A preferred stock and then distributed to

BlinkBio stockholders.

The BlinkBio Convertible Note had a conversion capitalization ceiling of $19.2 million, which limited the

price a noteholder must pay in a convertible note-to-common stock conversion occurrence.

On February 9, 2024, the 1,302,082 shares

of our Series A preferred stock were converted into 651,041 shares of common stock (on a post-split basis).

May 2021, we received the first of two tranches from TEDCO’s Rural & Underserved Business Recovery from Impact of

Covid-19 (RUBRIC) Grant in the amount of $50,000.

In October 2021, we received the second tranche of $50,000, which brought the

total reimbursable grant amount to $100,000.

We are obligated to report on and pay to TEDCO 3% of their quarterly revenues for a

five-year period following the reward date.

In October 2021, we received the second tranche of $50,000, which brought the total

reimbursable grant amount to $100,000.

We are obligated to report on and pay to TEDCO 3% of their quarterly revenues for a five-year

period following the reward date.

Income from grants and investments are not considered revenues.

Royalties due to TEDCO are

capped at 150% of the amount of the award, or $150,000.

We have the option to eliminate the quarterly royalty obligation by making an

advance payment prior to the end of the five-year period, in which case, we will receive a 10% reduction of the royalty cap percentage

for each year prior to the expiration of the five-year reimbursement period that the grant is repaid in full.

If we cease to meet eligibility

requirements at any time, the reimbursement obligation will become due to TEDCO immediately;

however, the discount for meeting the obligation

will still apply.

Royalties due to TEDCO are capped at

150% of the amount of the award, or $150,000.

We have the option to eliminate the quarterly royalty obligation by making an advance payment

prior to the end of the five-year period, in which case, we will receive a 10% reduction of the royalty cap percentage for each year prior

to the expiration of the five-year reimbursement period that the grant is repaid in full.

If we cease to meet eligibility requirements

at any time, the reimbursement obligation will become due to TEDCO immediately;

however, the discount for meeting the obligation will

PIPE Financing

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On July 11, 2025, we completed

the final closing of the Offering.

During the Inducement Period, we entered into Inducement Letters with the Holders of Existing Warrants,

pursuant to which the Holders agreed to exercise for cash their Existing Warrants to purchase an aggregate of 3,764,995 shares of our

common stock in consideration of our agreement to issue New Warrants to purchase up to an aggregate of 3,764,995 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.

We engaged an SEC registered

broker dealer and FINRA member (the “Solicitation Agent”) to act as our exclusive warrant solicitation agent in connection

with the Offering and agreed to pay the Solicitation Agent a cash fee equal to 5.0% of the total gross cash proceeds received from the

exercise by the Holders of their Existing Warrants during the Inducement Period.

We also agreed to pay the Solicitation Agent up to $15,000

for its reasonable legal and other expenses.

The gross proceeds to us from the Offering, before deducting transaction

fees and other estimated Offering expenses, were approximately $4,216,794.

We intend to use the net proceeds 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, advance strategic alternatives for our OS Animal Health subsidiary, close out and report

on our OST-504 (previously ADXS-504) prostate cancer study, initiate AI-driven next-generation tADC product candidate modeling and for

general corporate purposes.

the final closing of the First Offering.

On September 2, 2025, we closed on the Second Offering.

During the Inducement Periods, we entered

into Inducement Letters with the Holders of Existing Warrants, pursuant to which the Holders agreed to exercise for cash their Existing

Warrants to purchase an aggregate of 4,566,391 shares of our common stock in consideration of our agreement to issue New Warrants to purchase

up to an aggregate of 4,566,391 shares of our common stock at an exercise price of $3.00 per share, subject to adjustment as provided

The New Warrants are immediately exercisable from the date of issuance and have a term of exercise of five years from such date.

Pursuant to the terms of

the Inducement Letters, if the exercise of any Existing Warrant by a Holder would have resulted in such Holder exceeding the beneficial

ownership limitation contained in the Existing Warrants, the Holder agreed to pre-fund the exercise of its Existing Warrants for cash

at $1.119 per share.

Upon such pre-funding, the exercise price of the Holder’s Existing Warrants was reduced to $0.001 per share,

and such Existing Warrants became exercisable for our common stock solely at the Remaining Exercise Price.

A Holder pre-funded the exercise

of 937,500 of its Existing Warrants and agreed to receive 937,500 prepaid shares of common stock that will be issued in the future.

We engaged the Solicitation

Agent to act as our exclusive warrant solicitation agent in connection with the Offerings and agreed to pay the Solicitation Agent a cash

fee equal to (i) 5.0% of the total gross cash proceeds received from the exercise by the Holders of their Existing Warrants during the

First Inducement Period and (ii) 1.5% of the total gross cash proceeds received from the exercise by the Holders of their Existing Warrants

during the Second Inducement Period.

We also agreed to pay the Solicitation Agent up to $15,000 for its legal and other expenses.

The gross proceeds to us

from the Offerings, before deducting transaction fees and other estimated Offering expenses, were approximately $6,798,159.

the net proceeds from the 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, advance strategic

alternatives for our OS Animal Health subsidiary, close out and report on our OST-504 (previously ADXS-504) prostate cancer study, initiate

AI-driven next-generation tADC product candidate modeling and for general corporate purposes.

ATM Equity Offering Program

On August 8, 2025, we entered

into the Sales Agreement with the Sales Agents relating to shares of our common stock.

Pursuant to the Sales Agreement, we may offer and

sell shares of our common stock from time to time having an aggregate offering price of up to $18,000,000 through or to the Sales Agents.

We will pay each of the Sales Agents a total commission for its services in acting as agent in the sale of common stock up to 3.0% of

the gross sales price per share of all shares sold through it as agent under the Sales Agreement.

The amount of proceeds we will receive

will depend upon the actual number of shares of our common stock sold and the market price at which such shares are sold.

Because there

is no minimum offering amount required as a condition to close, 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 the date of this filing, we have sold an aggregate of 189,600 shares of our common stock

for aggregate gross proceeds of $384,888 pursuant to the Sales Agreement.

Contractual Obligations and Other Commitments

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candidate (OST-HER2).

The agreement was subsequently amended in April 2021 to modify the payment amounts for Milestones 2 and 3

listed in the table below.

Under the terms of the amended agreement, we are required to pay to Advaxis (i) a one-time, non-refundable

payment of $1,550,000 (the “License Commencement Payment”) and (ii) certain amounts based on the achievement of the

milestones described in the payment schedule below.

For the six months ended June 30, 2025 and for the year ended December 31, 2024,

no payments were made.

A $400,000 payment was made to Ayala, together with payment of stock consideration, in connection with our purchase

of the HER2 Assets on April 9, 2025, terminating this license agreement.

The payment schedule for milestones and corresponding payment

amounts were as set forth below.

The agreement was subsequently amended in April 2021 to modify the payment amounts for Milestones 2 and 3 listed

in the table below.

Under the terms of the amended agreement, we are required to pay to Advaxis (i) a one-time, non-refundable payment

of $1,550,000 (the “License Commencement Payment”) and (ii) certain amounts based on the achievement of the milestones

described in the payment schedule below.

For the nine months ended September 30, 2025 and for the year ended December 31, 2024, no payments

A $400,000 payment was made to Ayala, together with payment of stock consideration, in connection with our purchase of the

HER2 Assets on April 9, 2025, terminating this license agreement.

The payment schedule for milestones and corresponding payment amounts

were as set forth below.

Milestone Bearing Event

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to pay an annual fee to the Trustees of the University of Pennsylvania.

In April 2025, the Company paid a fee of $266,317 for the six

months ended June 30, 2025 for the period from April 9, 2025 through April 8, 2026.

In April 2025, the Company paid a fee of $266,317 for the nine

months ended September 30, 2025.

August 2020, we entered into a licensing agreement with BlinkBio, Inc., a privately held developer of drug conjugate therapies designed

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reductions on such royalty, and (iii) certain amounts based on the achievement of the milestones described in the payment schedule

As of June 30, 2025, we had paid the Up-Front Fee.

The payment schedule

for milestones and corresponding payment amounts is set forth below.

As of September 30, 2025,

we had paid the Up-Front Fee.

The payment schedule for milestones and corresponding payment amounts is set forth below.

Milestone Bearing Event

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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.” Under the terms of the agreement, we are required to pay to George Clinical certain fees described in

the fee schedule below.

The total new budget under the agreement is approximately $2,436,928.

For the six months ended June 30, 2025 and

2024, we paid $0 and $86,687, respectively, to George Clinical.

These payments have been recorded as research and development expenses

in our Statement of Operations and Comprehensive Loss.

The fee schedule for certain fees and corresponding payment amounts is set forth

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.” Under the terms of the agreement,

we are required to pay to George Clinical certain fees described in the fee schedule below.

The total new budget under the agreement is

approximately $2,436,928.

For the nine months ended September 30, 2025 and 2024, we paid $0 and $86,687, respectively, to George Clinical.

These payments have been recorded as research and development expenses in our Statement of Operations and Comprehensive Loss.

schedule for certain fees and corresponding payment amounts is set forth below.

George Clinical Payment Schedule

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The PTC Fee Advance will be used to offset the first few months of invoices payable.

As of June 30, 2025 and 2024, the balance

due to George Clinical was $0 and $663,622, respectively.

As of September 30, 2025 and 2024,

the balance due to George Clinical was $0 and $663,622, respectively.

The services agreement has terminated on its terms.

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its use in the respective regions:

Medicines Agency (EMA, Europe);

Evaluation Board (MEB, Netherlands);

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

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).

For the six months ended June 30, 2025, we paid

$459,485 in consulting fees, with accounts payable as of June 30, 2025 of $1,118,343.

For the nine months ended September 30, 2025,

we paid $2,397,131 in consulting fees, with accounts payable as of September 30, 2025 of $2,022,496.

The contract with Biolacuna is estimated

to exceed $5.2 million in 2025.

Off-Balance Sheet Arrangements

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issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2

to Notes to the Financial Statements appearing elsewhere in this report.

to Notes to the Consolidated financial statements appearing elsewhere in this report.

The JOBS Act permits an emerging

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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-Q

Item 2. Management’s Discussion and Analysis