What changed in this filing

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Item 2. Management’s Discussion and Analysis

2024-11-15 compared with 2024-08-14 · 492 added, 522 removed, 117 unchanged (90% of the section changed)

Management’s Discussion and Analysis

of Financial Condition and Results of Operations.

The following discussion

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.

Cautionary Note Regarding Forward-Looking Statements

This report contains “forward-looking

statements” (within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and

Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)), which may include information concerning

our beliefs, plans, objectives, goals, expectations, strategies, anticipations, assumptions, estimates, intentions, future events, future

revenues or performance, capital expenditures and other information that is not historical information.

Forward-looking statements involve

known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause our actual results, performance

or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking

When used in this report, the words “seek,” “estimate,” “expect,” “anticipate,”

“project,” “plan,” “contemplate,” “plan,” “continue,” “intend,”

“believe” and variations of such words or similar expressions are intended to identify forward-looking statements.

All forward-looking

statements are based upon our current expectations and various assumptions.

We believe there is a reasonable basis for its expectations

and beliefs, but there can be no assurance that we will realize its expectations or that its beliefs will prove to be correct.

There are a number of risks

and uncertainties that could cause our actual results to differ materially from the forward-looking statements contained in this report.

Examples of risks and uncertainties that could cause actual results to differ materially from historical performance and any forward-looking

statements include, but are not limited to, the risks described under the section below titled “Risk Factors” of our Registration

Statement on Form S-1 initially filed with the Securities and Exchange Commission (the “SEC”) on May 30, 2024, as well as

any subsequent filings with the SEC.

There may be other factors

of which we are currently unaware or which it currently deems immaterial that may cause its actual results to differ materially from the

forward-looking statements.

All forward-looking statements attributable to us or persons acting on our behalf apply only as of the date

they are made and are expressly qualified in their entirety by the cautionary statements included in this report.

Except as may be required

by law, we undertake no obligation to publicly update or revise any forward-looking statement to reflect events or circumstances occurring

after the date they were made or to reflect the occurrence of unanticipated events, or otherwise.

We make available through

its Internet website, free of charge, its Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, and

amendments to such reports and other filings made by us with the SEC, as soon as practicable after we electronically file such reports

and filings with the SEC.

Management’s Discussion and Analysis of Financial Condition and Results of Operations.

following discussion 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.

Note Regarding Forward-Looking Statements

report contains “forward-looking statements” (within the meaning of Section 27A of the Securities Act of 1933, as amended

(the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”)),

which may include information concerning our beliefs, plans, objectives, goals, expectations, strategies, anticipations, assumptions,

estimates, intentions, future events, future revenues or performance, capital expenditures and other information that is not historical

Forward-looking statements involve known and unknown risks, uncertainties and other factors, which may be beyond our control,

and which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements

expressed or implied by such forward-looking statements.

When used in this report, the words “seek,” “estimate,”

“expect,” “anticipate,” “project,” “plan,” “contemplate,” “plan,”

“continue,” “intend,” “believe” and variations of such words or similar expressions are intended

to identify forward-looking statements.

All forward-looking statements are based upon our current expectations and various assumptions.

We believe there is a reasonable basis for its expectations and beliefs, but there can be no assurance that we will realize its expectations

or that its beliefs will prove to be correct.

are a number of risks and uncertainties that could cause our actual results to differ materially from the forward-looking statements

contained in this report.

Examples of risks and uncertainties that could cause actual results to differ materially from historical performance

and any forward-looking statements include, but are not limited to, the risks described under the section below titled “Risk Factors”

of our Registration Statements on Form S-1 initially filed with the Securities and Exchange Commission (the “SEC”) on May

30, 2024 and November 12, 2024, as well as any subsequent filings with the SEC.

may be other factors of which we are currently unaware or which it currently deems immaterial that may cause its actual results to differ

materially from the forward-looking statements.

All forward-looking statements attributable to us or persons acting on our behalf apply

only as of the date they are made and are expressly qualified in their entirety by the cautionary statements included in this report.

Except as may be required by law, we undertake no obligation to publicly update or revise any forward-looking statement to reflect events

or circumstances occurring after the date they were made or to reflect the occurrence of unanticipated events, or otherwise.

make available through its Internet website, free of charge, its Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current

Reports on Form 8-K, and amendments to such reports and other filings made by us with the SEC, as soon as practicable after we electronically

file such reports and filings with the SEC.

Our website address is www.ostherapies.com.

The information contained on our website is not incorporated by

reference into this report.

We are 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 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.

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.

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

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.

The information contained on our website is not

incorporated by reference into this report.

are 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 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.

We expect topline results from all 41

patients enrolled in the fourth quarter of 2024 and, if successful, intend to seek regulatory approval for OST-HER2 for the prevention

of metastases in Osteosarcoma in 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.

also own rights to OST-Tunable Drug Conjugate (OST-tADC) platform, a next generation antibody-drug conjugate (ADC) silicone dioxide linker

“Tunable” is a term used in drug development that refers to the properties that can be influenced by chemical

modifications, and “antibody-drug conjugate” or ADC is a term used to describe a drug made up of a monoclonal antibody attached

to a cytotoxic payload, or a highly active and toxic pharmaceutical molecule, through chemical linkers.

The ADC links an antibody that

can home in on a targeted tumor to deploy the cytotoxic payload or toxic agent against the tumor.

Furthering our founding mission, we

intend to investigate clinical indications for OST-tADC in Osteosarcoma and other solid tumors

new treatments have been approved by the FDA for human 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 of age.

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.

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

(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.

We have built a pipeline

of product candidates targeting multiple indications for solid cancers.

Our pipeline includes two drug technologies:

(i) OST-HER2,

an off-the-shelf immunotherapy, which is a type of cancer treatment that helps one’s immune system fight cancer, comprised of a

genetically weakened and modified strain of Listeria monocytogenes , a species of bacteria that causes the infection listeriosis,

that expresses HER2 peptides, and (ii) OST-tADC, a next generation tunable ADC with a plug-and-play platform that features tunable

pH sensitive silicone linkers (SiLinkers).

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

directly into and in the vicinity of solid tumors.

Our Technology Platform

We are in the process of

building a fully integrated platform technology to accelerate the development of a range of product candidates across multiple therapeutic

Our platform technology is intended to leverage our management’s in-depth experience in immunotherapy research, development

and manufacturing to enable us to pursue multiple therapeutic targets.

Our scientists and scientific advisors have accumulated decades

of collective experience in the field of immunotherapy, oncology and small-molecule drug production, contributing key insights and significant

achievement in our clinical development process.

Our Core Values

Our company’s three

core values are:

● Patient Impact.

We care deeply about what we

are building to change the future for patients.

We are developing therapies for significant unmet medical need.

● Empowerment.

We are all responsible for delivering

on our mission to develop new medicines for patients:

listen, speak up and engage.

● Collaboration.

We know that we are better together

and thrive when we challenge each other to find a better way for patients.

Our Growth Strategies

Our goal is to enrich and

lengthen the lives of patients by being a leading, fully integrated biotechnology company.

We are seeking to develop, manufacture and

commercialize multiple product candidates targeting orphan and non-orphan oncologic diseases across multiple tissue types and therapeutic

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 investigational new drug application (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.

Critical Accounting Policies and Significant

Judgments 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.

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.

Accounting Policies and Significant Judgments and Estimates

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.

We evaluate our estimates and assumptions on an ongoing basis.

Our actual results may differ from these estimates

under different assumptions or conditions.

Critical accounting policies

are those that, in management’s view, are most important to the portrayal of a company’s financial condition and results of

operations and most demanding on their calls on judgment, often as a result of the need to make estimates about the effect of matters

that are inherently uncertain and may change in subsequent periods.

While our significant accounting policies are described in more detail

in Note 2 to our financial statements appearing elsewhere in this 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.

Debt Discount and Redemption Premium

We evaluated the Group A

Convertible Notes, the Group B Convertible Notes, the Group C Convertible Notes and the Bridge Notes (collectively, the “Convertible

Notes”) in accordance with ASC 480, Distinguishing Liabilities from Equity (“ASC 480”) and determined that

the Convertible Notes are considered share-settled debt and should be recorded as a liability.

This conclusion was determined based on

the debt providing the holder with a variable number of shares at settlement with an aggregate fair value equal to the debt instrument’s

outstanding principal.

The general measurement guidance in ASC 480 requires obligations that can be settled in shares with a fixed

monetary value at settlement (e.g., share-settled debt) to be carried at fair value unless other accounting guidance specifies another

measurement attribute.

Our actual results may differ

from these estimates under different assumptions or conditions.

accounting policies are those that, in management’s view, are most important to the portrayal of a company’s financial condition

and results of operations and most demanding on their calls on judgment, often as a result of the need to make estimates about the effect

of matters that are inherently uncertain and may change in subsequent periods.

While our significant accounting policies are described

in more detail in Note 2 to our financial statements appearing elsewhere in this 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.

Discount and Redemption Premium

evaluated the Group A Convertible Notes, the Group B Convertible Notes, the Group C Convertible Notes and the Bridge Notes (collectively,

the “Convertible Notes”) in accordance with ASC 480, Distinguishing Liabilities from Equity (“ASC 480”)

and determined that the Convertible Notes are considered share-settled debt and should be recorded as a liability.

This conclusion was

determined based on the debt providing the holder with a variable number of shares at settlement with an aggregate fair value equal to

the debt instrument’s outstanding principal.

The general measurement guidance in ASC 480 requires obligations that can be

settled in shares with a fixed monetary value at settlement (e.g., share-settled debt) to be carried at fair value unless other accounting

guidance specifies another measurement attribute.

It has been determined that the appropriate guidance for share-settled debt is ASC 835.

As a result, the Convertible

Notes will be recorded at the amortized cost.

The initial fair value of

the redemption value relating to the convertible debt instruments are capitalized and amortized over the term of the related debt using

the straight-line method, which approximates the interest method.

If a loan is paid in full, any unamortized financing costs will be removed

from the related accounts and charged to operations.

Amortization of debt discount is recorded as a component of interest expense.

accordance with ASU 2015-03, Interest — Imputation of Interest, the unamortized debt discount is presented in the

accompanying balance sheet as a direct deduction from the carrying amount of the related debt.

As a result, the Convertible Notes will be recorded at the amortized cost.

initial fair value of the redemption value relating to the convertible debt instruments are capitalized and amortized over the term of

the related debt using the straight-line method, which approximates the interest method.

If a loan is paid in full, any unamortized financing

costs will be removed from the related accounts and charged to operations.

Amortization of debt discount is recorded as a component of

interest expense.

In accordance with ASU 2015-03, Interest — Imputation of Interest, the unamortized debt discount

is presented in the accompanying balance sheet as a direct deduction from the carrying amount of the related debt.

The fair value of the redemption

2 unchanged sentences

This PWERM was determined to be the most appropriate method of estimating the value of possible redemption

or conversion outcomes over time, since we have not entered into a priced equity round through June 30, 2024.

The fair value of the redemption

liability is calculated using the initial value of the Convertible Notes less the debt discount rate of 12.5% in Group A, 20% in Groups

B and C, and 50% in Groups D, E and F.

The redemption liability is then amortized over the remaining life of the note, utilizing the interest

rates of 10% and 6% for the groups, respectively.

The life of each note in Group A is for a set period of three years and is variable

in Groups B, C, D, E and F, with a range of 12 months to three years.

We retain the option to negotiate an extended maturity date for

Groups B, C, D, E and F.

The new embedded redemption values were $750,500 and $1,541,250 for the periods ended June 30, 2024 and December

31, 2023, respectively.

The fees associated with

the convertible debt raise are legal and investment fees associated with the issuance of the Convertible Notes for Groups A, B, C, D,

or conversion outcomes over time.

The fair value of the redemption liability is calculated using the initial value of the Convertible

Notes less the debt discount rate of 12.5% in Group A, 20% in Groups B and C, and 50% in Groups D, E and F.

The redemption liability is

then amortized over the remaining life of the note, utilizing the interest rates of 10% and 6% for the groups, respectively.

of each note in Group A is for a set period of three years and is variable in Groups B, C, D, E and F, with a range of 12 months to three

We retain the option to negotiate an extended maturity date for Groups B, C, D, E and F.

The new embedded redemption values were

$0 and $1,541,250 for the periods ended September 30, 2024 and December 31, 2023, respectively.

fees associated with the convertible debt raise are legal and investment fees associated with the issuance of the Convertible Notes for

Groups A, B, C, D, E and F.

There were no related parties who received these fees.

The fees are amortized over the life of the Convertible Notes utilizing

an interest rate of 10% for Group A and 6% for Groups B, C, D, E and F.

Components of Our Results of Operations

did not recognize revenues for the six months ended June 30, 2024 or the year ended December 31, 2023.

Operating Expenses.

operating expenses are comprised primarily of research and development expenses, general and administrative expenses and licensing costs.

Research and Development

The fees are amortized over the life of the Convertible

Notes utilizing an interest rate of 10% for Group A and 6% for Groups B, C, D, E and F.

convertible debt raises and all associated accounts were closed out to stockholders’ equity on August 2, 2024, which was the date

on which we consummated our initial public offering and all outstanding convertible notes automatically converted into shares of common

of Our Results of Operations

We did not recognize revenues for the nine months ended September 30, 2024 or the year ended December 31, 2023.

Our operating expenses are comprised primarily of research and development expenses, general and administrative expenses

and licensing costs.

and Development Expenses.

Research and development expenses consist primarily of costs incurred for our research activities,

including our drug discovery efforts, and the development of our product candidates, which include:

● personnel-related costs, including salaries, benefits and

stock-based compensation expense, for employees engaged in research and development functions;

● expenses incurred in connection with our research programs,

including under agreements with third parties, such as consultants and contractors and CROs;

● the cost of developing and scaling our manufacturing process

and manufacturing drug substance and drug product for use in our research and preclinical and clinical studies, including under agreements

with third parties, such as consultants and contractors and contract development and manufacturing organizations (CDMOs);

● the cost of laboratory supplies and research materials.

We track our direct external

research and development expenses on a program-by-program basis.

These consist of costs that include fees, reimbursed materials, and other

costs paid to consultants, contractors, CDMOs, and CROs in connection with our preclinical, clinical and manufacturing activities.

do not allocate employee costs, costs associated with our discovery efforts, and facilities expenses, including depreciation or other

indirect costs, to specific product development programs because these costs are deployed across multiple programs and, as such, are not

separately classified.

We expect that our research

and development expenses will increase substantially as we advance OST-HER2 and OST-tADC into clinical development and expand our discovery,

research and preclinical activities in the near term and in the future.

General and Administrative

General and administrative expenses consist primarily of salaries and related costs, including

stock-based compensation, for personnel in executive, finance and administrative functions.

General and administrative expenses also include

professional fees for legal, patent, consulting, investor and public relations and accounting and audit services.

We anticipate that our general

and administrative expenses will increase in the future as we increase our headcount to support our continued research activities and

development of our product candidates.

We also anticipate that we will incur increased accounting, audit, legal, regulatory, compliance,

and director and officer insurance costs as well as investor and public relations expenses associated with operating as a public company.

Licensing Costs.

incurred in obtaining technology licenses and asset purchases are charged to licensing costs if the technology licensed has not reached

technological feasibility which includes manufacturing, clinical, intellectual property and/or regulatory success which has no alternative

The licenses purchased by us require substantial completion of research and development and regulatory and marketing approval

efforts in order to reach technological feasibility.

Interest Expense.

evaluated the Convertible Notes in accordance with ASC 480, Distinguishing Liabilities from Equity (“ASC 480”),

personnel-related

costs, including salaries, benefits and stock-based compensation expense, for employees engaged in research and development functions;

incurred in connection with our research programs, including under agreements with third parties, such as consultants and contractors

cost of developing and scaling our manufacturing process and manufacturing drug substance and drug product for use in our research

and preclinical and clinical studies, including under agreements with third parties, such as consultants and contractors and contract

development and manufacturing organizations (CDMOs);

cost of laboratory supplies and research materials.

track our direct external research and development expenses on a program-by-program basis.

These consist of costs that include fees,

reimbursed materials, and other costs paid to consultants, contractors, CDMOs, and CROs in connection with our preclinical, clinical

and manufacturing activities.

We do not allocate employee costs, costs associated with our discovery efforts, and facilities expenses,

including depreciation or other indirect costs, to specific product development programs because these costs are deployed across multiple

programs and, as such, are not separately classified.

expect that our research and development expenses will increase substantially as we advance OST-HER2 and OST-tADC into clinical development

and expand our discovery, research and preclinical activities in the near term and in the future.

and Administrative Expenses.

General and administrative expenses consist primarily of salaries and related costs, including stock-based

compensation, for personnel in executive, finance and administrative functions.

General and administrative expenses also include professional

fees for legal, patent, consulting, investor and public relations and accounting and audit services.

anticipate that our general and administrative expenses will increase in the future as we increase our headcount to support our continued

research activities and development of our product candidates.

We also anticipate that we will incur increased accounting, audit, legal,

regulatory, compliance, and director and officer insurance costs as well as investor and public relations expenses associated with operating

as a public company.

Costs incurred in obtaining technology licenses and asset purchases are charged to licensing costs if the technology licensed

has not reached technological feasibility which includes manufacturing, clinical, intellectual property and/or regulatory success which

has no alternative future use.

The licenses purchased by us require substantial completion of research and development and regulatory

and marketing approval efforts in order to reach technological feasibility.

We evaluated the Convertible Notes in accordance with ASC 480, Distinguishing Liabilities from Equity (“ASC 480”),

and determined the Convertible Notes are considered share-settled debt and should be recorded as a liability.

This conclusion was determined

based on the debt providing the holder with a variable number of shares at settlement with an aggregate fair value equal to the debt instrument’s

outstanding principal.

The general measurement guidance in ASC 480 requires obligations that can be settled in shares with a fixed

monetary value at settlement (e.g., share-settled debt) to be carried at fair value unless other accounting guidance specifies another

measurement attribute.

based on the debt providing the holder with a variable number of shares at settlement with an aggregate fair value equal to the debt

instrument’s outstanding principal.

The general measurement guidance in ASC 480 requires obligations that can be settled in

shares with a fixed monetary value at settlement (e.g., share-settled debt) to be carried at fair value unless other accounting guidance

specifies another measurement attribute.

It has been determined that the appropriate guidance for share-settled debt is ASC 835.

As a result, the Convertible

Notes were recorded at the amortized cost.

As a result, the Convertible Notes were recorded at the amortized cost.

Cumulative Series A

Preferred Stock Dividend.

The Series A preferred stock dividend requirement represents the coupon

dividends on our preferred stock and is identified as a separate component of our statement of operations to compute net income (loss)

available to common shareholders.

The Series A preferred stock dividend requirement represents the coupon dividends on our preferred

stock and is identified as a separate component of our statement of operations to compute net income (loss) available to common shareholders.

The coupon dividends are computed at 5% of the principal per annum and are recorded monthly.

The cumulative

accrued dividend at June 30, 2024 and 2023 was $375,000 and $250,000, 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.

our inception, we have not recorded income tax benefits for the net operating losses incurred or the research and development tax credits

generated in each year, due to the uncertainty of realizing a benefit from those items.

As of December 31, 2023,

federal net operating loss carry forwards of approximately $16.3 million, which may be available to offset future taxable

The federal net operating loss carry forward indefinitely but may only be used to offset 80% of annual taxable income.

The cumulative accrued dividend at September

30, 2024 and 2023 was $375,000 and $312,500, 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.

Since our inception, we have not recorded income tax benefits for the net operating losses incurred or the research and

development tax credits generated in each year, due to the uncertainty of realizing a benefit from those items.

of December 31, 2023, we had U.S.

federal net operating loss carry forwards of approximately $16.3 million, which may be available

to offset future taxable income.

The federal net operating loss carry forward indefinitely but may only be used to offset 80% of annual

taxable income.

As of December 31, 2023, we also had federal and state general business tax credit carry forwards of $1.4 million

available to offset future tax liabilities and expire at various dates beginning in January 1, 2022.

We have R&D credits that

we opted to convert and use toward payroll taxes in amounts equal to $0.3 million as of December 31, 2023.

As of December 31, 2023,

2023, we also had federal and state general business tax credit carry forwards of $1.4 million available to offset future tax liabilities

and expire at various dates beginning in January 1, 2022.

We have R&D credits that we opted to convert and use toward payroll

taxes in amounts equal to $0.3 million as of December 31, 2023.

As of December 31, 2023, we also had a federal and state research

and development tax credit carry forwards of approximately $0.3 million, which may be available to offset future tax liabilities and expire

at various dates beginning January 1, 2024 and January 1, 2023, respectively.

Deferred Offering Costs.

offering costs consisted of legal, accounting, printing and filing fees that we capitalized, which will be offset against the gross proceeds

from our initial public offering.

Results of Operations

Six Months Ended June 30, 2024 Compared

to Six Months Ended June 30, 2023

we also had a federal and state research and development tax credit carry forwards of approximately $0.3 million, which may be available

to offset future tax liabilities and expire at various dates beginning January 1, 2024 and January 1, 2023, respectively.

Offering Costs.

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

be offset against the gross proceeds from our initial public offering.

of Operations

Three Months Ended September 30, 2024 Compared

to Three Months Ended September 30, 2023

The following table summarizes

our results of operations for the six months ended June 30, 2024 and 2023:

our results of operations for the three months ended September 30, 2024 and 2023:

September 30,

(In thousands)

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Research and Development

Research and development expenses were approximately $0.8 million for the six months

ended June 30, 2024 compared to approximately $1.7 million for the six months ended June 30, 2023.

This decrease was primarily

due to a decrease in vendor expenses associated with our Phase IIb clinical trial and a decrease in vendor expenses associated with

out OST-tADC platform technology.

The following table summarizes our research and development expenses for the three months ended

June 30, 2024 and 2023:

As of June 30,

Research and development expenses were approximately $1.2 million for the three months ended September 30, 2024

compared to approximately $0.5 million for the three months ended September 30, 2023.

This decrease was primarily due to a decrease

in vendor expenses associated with our Phase IIb clinical trial and a decrease in vendor expenses associated with out OST-tADC platform

The following table summarizes our research and development expenses for the three months ended September 30, 2024 and

As of September 30,

(In thousands)

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Total research and development expenses

For the six months ended

June 30, 2024 and 2023, the direct research and development expenses related to OST-HER2 were primarily lab fees, vendor expenses and

staff payroll fees.

For the three months ended

September 30, 2024 and 2023, the direct research and development expenses related to OST-HER2 were primarily lab fees, vendor expenses

and staff payroll fees.

In 2024, 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 $0.2 million for the six months ended June 30, 2024 and 2023, respectively.

expenses were approximately $0.0 million and $0.0 million for the three months ended September 30, 2024 and 2023, respectively.

General and Administrative

General and administrative expenses for the six months ended June 30, 2024 were approximately

$0.7 million compared to $0.8 million for the six months ended June 30, 2023.

These expenses were primarily attributed

to marketing costs and accounting fees to consultants.

General and administrative expenses for the three months ended September 30, 2024 were approximately $1.2 million

compared to $0.2 million for the three months ended September 30, 2023.

These expenses were primarily attributed to marketing costs

and accounting fees to consultants.

Licensing Costs.

did not have any licensing costs for the six months ended June 30, 2024 and 2023.

did not have any licensing costs for the three months ended September 30, 2024 and 2023.

Interest Expense.

expense for the six months ended June 30, 2024 was approximately $1.6 million compared to $1.8 million for the six months

ended June 30, 2023.

to the amounts of interest are comprised of accretion of debt discount being amortized in 2024 and 2023 from associated

discounts related to convertible notes and placement agent warrants, together with interest expenses from the issuances of convertible

Liquidity and Capital Resources

Operating Losses

expense for the three months ended September 30, 2024 was approximately $0.4 million compared to $1.4 million for the three

months ended September 30, 2023.

The amounts of interest are comprised of accretion of debt discount being amortized in 2024 and 2023

from associated discounts related to convertible notes and placement agent warrants, together with interest expenses from the issuances

of convertible notes.

Months Ended September 30, 2024 Compared to Nine Months Ended September 30, 2023

following table summarizes our results of operations for the nine months ended September 30, 2024 and 2023:

September 30,

(In thousands)

Research and development expenses

General and administrative

Total operating expenses

Loss from operations

Other income (expenses):

Interest Income

Interest expense

Total other expenses

Cumulative Series A preferred stock dividend requirement

Net loss available to common shareholders

$ (5,922,954 )

$ (6,420,766 )

Research and Development

Research and development expenses were approximately $1.9 million for the nine months ended September 30, 2024

compared to approximately $2.2 million for the nine months ended September 30, 2023.

This decrease was primarily due to a decrease

in vendor expenses associated with our Phase IIb clinical trial and a decrease in vendor expenses associated with out OST-tADC platform

The following table summarizes our research and development expenses for the nine months ended September 30, 2024 and

As of September 30,

(In thousands)

Direct research and development expenses by program:

Unallocated research and development expenses:

Personnel-related

Total research and development expenses

For the nine months ended

September 30, 2024 and 2023, the direct research and development expenses related to OST-HER2 were primarily lab fees, vendor expenses

and staff payroll fees.

In 2024, such expenses were primarily lab fees and related clinical support of approximately $1.6 million attributed

to our Phase IIb clinical trial preparation and CRO costs as we completed IND-enabling studies.

OST-tADC related direct research and development

expenses were approximately $0.0 million and $0.2 million for the nine months ended September 30, 2024 and 2023, respectively.

and Administrative Expenses.

General and administrative expenses for the nine months ended September 30, 2024 were approximately

$1.9 million compared to $1.0 million for the nine months ended September 30, 2023.

These expenses were primarily attributed

to marketing costs and accounting fees to consultants.

We did not have any licensing costs for the nine months ended September 30, 2024 and 2023.

Interest expense for the nine months ended September 30, 2024 was approximately $2.0 million compared to $3.1 million

for the nine months ended September 30, 2023.

The amounts of interest are comprised of accretion of debt discount being amortized in

2024 and 2023 from associated discounts related to convertible notes and placement agent warrants, together with interest expenses from

the issuances of convertible notes.

and Capital Resources

Since our inception, we have

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

For the six months ended June 30, 2024 and 2023,

For the nine months ended September 30, 2024 and

2023, we reported a net loss of approximately $5.9 million and $6.4 million, respectively, and had an accumulated deficit of approximately

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losses for the foreseeable future.

As of June 30, 2024 and 2023,

we had cash of approximately $0.1 million and $0.0 million, respectively.

We have funded our operations to date primarily from the sale

of our convertible notes in our private placements, which have provided total gross proceeds of $19.2 million as of June 30, 2024.

believe that the net proceeds from our private placements, together with our existing cash, will enable us to fund our operating expenses

and capital expenditure requirements for the next three to six months.

The following table summarizes

our sources and uses of cash for each of the periods presented:

As of September 30, 2024

and 2023, we had cash of approximately $1.9 million and $0.02 million, respectively.

We have funded our operations to date primarily from

the sale of our convertible notes in our private placements, which have provided total gross proceeds of $19.2 million as of July 31,

We believe that the net proceeds from our private placements, together with our existing cash, will enable us to fund our operating

expenses and capital expenditure requirements for the next three to nine months.

consummated our initial public offering on August 2, 2024, converting all our outstanding Convertible Notes into common stock and raising

$6.4 million in gross proceeds on the sale of 1.6 million shares of our common stock.

Net proceeds from our initial public offering were

used to pay off accounts payable and fund continuing losses through September 30, 2024.

following table summarizes our sources and uses of cash for each of the periods presented:

September 30,

(In thousands)

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Net increase (decrease) in cash

Operating Activities

During the six months ended

June 30, 2024 and 2023, operating activities used approximately $1.5 million and $1.3 million of cash, respectively, resulting from

our net loss of approximately $3.0 million and $4.4 million, respectively, offset by net non-cash charges of approximately $1.1 million

and $1.6 million, respectively, partially offset by net cash provided by changes in our operating assets and liabilities of approximately

$0.4 million and $1.5 million, respectively.

the nine months ended September 30, 2024 and 2023, operating activities used approximately $4.9 million and $2.1 million of cash,

respectively, resulting from our net loss of approximately $5.9 million and $6.3 million, respectively, offset by net non-cash charges

of approximately $1.4 million and $2.6 million, respectively, partially offset by net cash provided by changes in our operating

assets and liabilities of approximately $(0.4) million and $1.6 million, respectively.

Net cash provided by changes

in our operating assets and liabilities for the six months ended June 30, 2024 and 2023 consisted primarily of an increase in accounts

payable of approximately $0.0 million and $1.3 million, respectively, an increase in accrued interest of approximately $0.5 million

and $0.3 million, respectively, and a change in accrued payroll of approximately $(0.0) million and $(0.1) million, respectively.

Non-cash charges for the

six months ended June 30, 2024 and 2023 were primarily the result of the amortization of debt discount on our convertible debt of approximately

$1.1 million and $1.5 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, 2024 and 2023, net cash provided by investing activities was approximately $0.0 million and $0.0 million, respectively.

Financing Activities

During the six months ended June 30, 2024 and 2023, net cash provided

by financing activities was approximately $1.6 million and $1.1 million, respectively.

The net cash provided by financing activities

for the six months ended June 30, 2024 and 2023 consisted primarily of net proceeds from sales of convertible notes, reduced by capitalized

deferred offering costs.

Convertible Notes

We have completed seven separate

private financing transactions from July 2018 to April 2024 in which we issued the Convertible Notes and raised total gross proceeds

of $19,186,520 from accredited investors.

Information with respect

to the seven separate private financings of convertible notes — A, B, C, D, E, F and BlinkBio — are indicated

in the table below.

June 30, 2024

in our operating assets and liabilities for the nine months ended September 30, 2024 and 2023 consisted primarily of an increase (decrease)

in accounts payable of approximately $(0.9) million and $1.1 million, respectively, an increase in accrued interest of approximately

$0.6 million and $0.7 million, respectively, and a change in accrued payroll of approximately $(0.1) million and $(0.1) million,

respectively.

charges for the nine months ended September 30, 2024 and 2023 were primarily the result of the amortization of debt discount on our convertible

debt of approximately $1.4 million and $2.4 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.

the nine months ended September 30, 2024 and 2023, net cash provided by investing activities was approximately $0.0 million and $0.0 million,

respectively.

the nine months ended September 30, 2024 and 2023, net cash provided by financing activities was approximately $6.7 million and $2.0 million,

respectively.

The net cash provided by financing activities for the nine months ended September 30, 2024 and 2023 consisted of net proceeds

from sales of convertible notes and our initial public offering, reduced by capitalized deferred offering costs.

have completed seven separate private financing transactions from July 2018 to April 2024 in which we issued the Convertible Notes

and raised total gross proceeds of $19,186,520 from accredited investors.

with respect to the seven separate private financings of convertible notes — A, B, C, D, E, F and BlinkBio — are

indicated in the table below.

September 30,

2023 carrying amount

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The total accrued interest

on the convertible notes listed in the table above was approximately $2.5 million and $2.0 million as of June 30, 2024 and December

on the convertible notes listed in the table above was approximately $0.0 million and $2.0 million as of September 30, 2024 and December

31, 2023, respectively.

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The material terms of each group of Convertible Notes are described below.

Group A Convertible

From July 2018 through November 2021, we issued convertible notes in an aggregate principal

amount of $1,154,000 (the “Group A Convertible Notes”) to accredited investors, including related parties.

Interest on the

unpaid principal balance on the Group A Convertible Notes accrued at a rate of 10% per annum, computed on the basis of the actual number

of days elapsed and a year of 365 days.

Unless earlier converted into shares of Equity Securities, the principal and accrued

interest on the Group A Convertible Notes were due and payable by us on demand by the holders of such convertible notes at any time after

the earlier of (i) the Maturity Date and (ii) the closing of the Next Equity Financing (which was our initial public offering).

In general, the stated Maturity Date varied from the date of issuance of two to four years and was extended in October 2023,

under the same terms, until October 31, 2024.

The Group A Convertible Notes

automatically converted into shares of our common stock upon the consummation of our initial public offering.

The number of shares of

our common stock issued upon the automatic conversion was equal to the quotient obtained by dividing the outstanding principal and unpaid

accrued interest due on the Group A Convertible Note on the date of conversion by a percentage between 80% to 87.5%, as applicable, of

the initial public offering price per share in such offering.

The Group A Convertible Notes had conversion capitalization ceilings that

ranged from $5 million to $25 million, which limited the price a noteholder must pay in a convertible note-to-common stock conversion

The Group A Convertible Notes had a conversion price that ranged from $0.39 to $1.97 per share, depending on the applicable

valuation ceiling of each note (based on the initial public offering price of $4.00 per share).

Group B Convertible

From April 2020 through June 2021, we issued convertible notes in an aggregate principal

amount of $5,154,000 (the “Group B Convertible Notes”) to accredited investors.

Interest on the unpaid principal balance of

the Group B Convertible Notes accrued at a rate of 6% per annum, computed on the basis of the actual number of days elapsed and a

year of 365 days.

The Convertible Notes, including interest accrued thereon,

automatically converted into common stock upon consummation of our initial public offering on August 2, 2024.

A Convertible Notes.

From July 2018 through November 2021, we issued convertible notes in an aggregate principal amount

of $1,154,000 (the “Group A Convertible Notes”) to accredited investors, including related parties.

Interest on the unpaid

principal balance on the Group A Convertible Notes accrued at a rate of 10% per annum, computed on the basis of the actual number of days

elapsed and a year of 365 days.

Unless earlier converted into shares of Equity Securities, the principal and accrued interest on

the Group A Convertible Notes were due and payable by us on demand by the holders of such convertible notes at any time after the earlier

of (i) the Maturity Date and (ii) the closing of the Next Equity Financing (which was our initial public offering).

the stated Maturity Date varied from the date of issuance of two to four years and was extended in October 2023, under the

same terms, until October 31, 2024.

Group A Convertible Notes automatically converted into shares of our common stock upon the consummation of our initial public offering.

The number of shares of our common stock issued upon the automatic conversion was equal to the quotient obtained by dividing the outstanding

principal and unpaid accrued interest due on the Group A Convertible Note on the date of conversion by a percentage between 80% to 87.5%,

as applicable, of the initial public offering price per share in such offering.

The Group A Convertible Notes had conversion capitalization

ceilings that ranged from $5 million to $25 million, which limited the price a noteholder must pay in a convertible note-to-common

stock conversion occurrence.

The Group A Convertible Notes had a conversion price that ranged from $0.39 to $1.97 per share, depending

on the applicable valuation ceiling of each note (based on the initial public offering price of $4.00 per share).

B Convertible Notes.

From April 2020 through June 2021, we issued convertible notes in an aggregate principal amount

of $5,154,000 (the “Group B Convertible Notes”) to accredited investors.

Interest on the unpaid principal balance of the

Group B Convertible Notes accrued at a rate of 6% per annum, computed on the basis of the actual number of days elapsed and a year

Unless earlier converted into shares of Equity Securities, the principal and accrued interest were due and payable

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2022 but was extended in October 2023, under the same terms, until October 31, 2024.

The Group B Convertible Notes

automatically converted into shares of our common stock upon the consummation of our initial public offering.

The number of shares of

our common stock issued upon the automatic conversion was equal to the quotient obtained by dividing the outstanding principal and unpaid

accrued interest due on the Group B Convertible Note on the date of conversion by 80% of the initial public offering price per share in

such offering.

The Group B Convertible Notes had a conversion capitalization ceiling of $19 million, which limited the price a noteholder

Group B Convertible Notes automatically converted into shares of our common stock upon the consummation of our initial public offering.

The number of shares of our common stock issued upon the automatic conversion was equal to the quotient obtained by dividing the outstanding

principal and unpaid accrued interest due on the Group B Convertible Note on the date of conversion by 80% of the initial public offering

price per share in such offering.

The Group B Convertible Notes had a conversion capitalization ceiling of $19 million, which limited

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

As a result of the valuation ceiling, the

Group B Convertible Notes had a conversion price of $1.31 per share (based on the initial public offering price of $4.00 per share).

C Convertible Notes.

From June 2021 through January 2023, we issued convertible notes in an aggregate principal amount of

$3,945,020 (the “Group C Convertible Notes”) to accredited investors.

Interest on the unpaid principal balance of the Group

C Convertible Notes accrued at a rate of 6% per annum, computed on the basis of the actual number of days elapsed and a year of

Unless earlier converted into shares of Equity Securities, the principal and accrued interest were due and payable by

us on demand by the holders of such convertible notes at any time after the earlier of (i) the Maturity Date and (ii) the closing

of the Next Equity Financing (which was our initial public offering).

In general, the stated Maturity Date was May 31, 2024 but

was extended in October 2023, under the same terms, until October 31, 2024.

Group C Convertible Notes automatically converted into shares of our common stock upon the consummation of our initial public

The number of shares of our common stock issued upon the automatic conversion was equal to the quotient obtained by

dividing the outstanding principal and unpaid accrued interest due on the Group C Convertible Note on the date of conversion by 80%

of the initial public offering price per share in such offering.

The Group C Convertible Notes had a conversion capitalization

ceiling of $50 million, except that one note was subject to a valuation ceiling of $19 million, which limited the price a noteholder

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

As a result of the valuation ceiling, the Group B Convertible Notes

had a conversion price of $1.31 per share (based on the initial public offering price of $4.00 per share).

Group C Convertible

From June 2021 through January 2023, we issued convertible notes in an aggregate principal

amount of $3,945,020 (the “Group C Convertible Notes”) to accredited investors.

Interest on the unpaid principal balance of

the Group C Convertible Notes accrued at a rate of 6% per annum, computed on the basis of the actual number of days elapsed and a

year of 365 days.

Unless earlier converted into shares of Equity Securities, the principal and accrued interest were due and payable

by us on demand by the holders of such convertible notes at any time after the earlier of (i) the Maturity Date and (ii) the

closing of the Next Equity Financing (which was our initial public offering).

In general, the stated Maturity Date was May 31, 2024

but was extended in October 2023, under the same terms, until October 31, 2024.

The Group C Convertible Notes

automatically converted into shares of our common stock upon the consummation of our initial public offering.

The number of shares of

our common stock issued upon the automatic conversion was equal to the quotient obtained by dividing the outstanding principal and unpaid

accrued interest due on the Group C Convertible Note on the date of conversion by 80% of the initial public offering price per share in

such offering.

The Group C Convertible Notes had a conversion capitalization ceiling of $50 million, except that one note was subject

to a valuation ceiling of $19 million, which limited the price a noteholder must pay in a convertible note-to-common stock conversion

As a result of the applicable valuation ceiling, the Group C Convertible Notes had a conversion price of $1.31 or $2.59 per

share, as applicable (based on the initial public offering price of $4.00 per share).

Bridge Notes (Groups

As a result of the applicable valuation ceiling, the Group C

Convertible Notes had a conversion price of $1.31 or $2.59 per share, as applicable (based on the initial public offering price of

$4.00 per share).

Notes (Groups D, E and F).

In November 2022, we issued convertible notes in an aggregate principal amount of $2,000,000

(the “Group D Convertible Notes”) to accredited investors.

From February to June 2023, we issued convertible notes in an aggregate

principal amount of $1,100,000 (the “Group E Convertible Notes”) to accredited investors.

From June 2023 to April 2024, we

issued convertible notes in an aggregate principal amount of $3,433,500 (the “Group F Convertible Notes” and, collectively

with the Group D Convertible Notes and Group E Convertible Notes, the “Bridge Notes”) to accredited investors, of which

an aggregate of $750,000 was issued in April 2024.

Interest on the unpaid principal balance of the Bridge Notes accrued at a rate of 6%

per annum, computed on the basis of the actual number of days elapsed and a year of 365 days.

Unless earlier converted into

shares of Equity Securities, the principal and accrued interest was due and payable by us on demand by the holders of such convertible

From February to June 2023, we issued convertible notes in an

aggregate principal amount of $1,100,000 (the “Group E Convertible Notes”) to accredited investors.

From June 2023 to April

2024, we issued convertible notes in an aggregate principal amount of $3,433,500 (the “Group F Convertible Notes” and,

collectively with the Group D Convertible Notes and Group E Convertible Notes, the “Bridge Notes”) to accredited investors,

of which an aggregate of $750,000 was issued in April 2024.

Interest on the unpaid principal balance of the Bridge Notes accrued at a

rate of 6% per annum, computed on the basis of the actual number of days elapsed and a year of 365 days.

Unless earlier converted

into shares of Equity Securities, the principal and accrued interest was due and payable by us on demand by the holders of such convertible

notes at any time after the earlier of (i) the Maturity Date and (ii) the closing of the Next Equity Financing (which was our

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In general, the stated Maturity Date was October 31, 2024.

The Bridge Notes automatically

converted into shares of our common stock upon the consummation of our initial public offering.

The number of shares of our common stock

issued upon the automatic conversion was equal to the quotient obtained by dividing the outstanding principal and unpaid accrued interest

due on a Bridge Note on the date of conversion by 50% of the initial public offering price per share in such offering.

The Bridge Notes

had a conversion capitalization ceiling of $50 million, which limited the price a noteholder must pay in a convertible note-to-common

stock conversion occurrence.

As a result of the valuation ceiling, the Bridge Notes had a conversion price of $2.00 per share (based on

the initial public offering price of $4.00 per share).

Demand Notes.

On March 6, 2024 and June 28, 2024, we issued demand promissory notes

to a lender who was an investor in one of our prior convertible notes rounds in a principal amount of $100,000 and $150,000, respectively.

The demand notes bear interest at a rate of 8% per annum and the principal plus all accrued interest is payable upon demand by such lender.

If such notes are not paid on demand by us, interest will accrue at a rate of the lesser of 16% per annum and the highest rate of interest

allowable under Maryland law.

As of August 14, 2024, we have repaid the demand notes in full.

August 19, 2020, we issued a convertible note with a principal amount of $2,400,000 (the “BlinkBio Convertible Note”)

to BlinkBio, Inc., which is a related party based on Dr.

Goddard being our Chairman and as the Chairman and Chief Executive Officer

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).

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.

Bridge Notes automatically converted into shares of our common stock upon the consummation of our initial public offering.

of shares of our common stock issued upon the automatic conversion was equal to the quotient obtained by dividing the outstanding principal

and unpaid accrued interest due on a Bridge Note on the date of conversion by 50% of the initial public offering price per share in such

The Bridge Notes had a conversion capitalization ceiling of $50 million, which limited the price a noteholder must pay

in a convertible note-to-common stock conversion occurrence.

As a result of the valuation ceiling, the Bridge Notes had a conversion

price of $2.00 per share (based on the initial public offering price of $4.00 per share).

On March 6, 2024 and June 28, 2024, we issued demand promissory notes to a lender who was an investor in one of our prior

convertible notes rounds in a principal amount of $100,000 and $150,000, respectively.

The demand notes bear interest at a rate of 8%

per annum and the principal plus all accrued interest is payable upon demand by such lender.

If such notes are not paid on demand by

us, interest will accrue at a rate of the lesser of 16% per annum and the highest rate of interest allowable under Maryland law.

of August 14, 2024, we have repaid the demand notes in full.

On August 19, 2020, we issued a convertible note with a principal amount of $2,400,000 (the “BlinkBio Convertible

Note”) to BlinkBio, Inc., which is a related party based on Dr.

Goddard being our Chairman and as the Chairman and Chief Executive

Officer 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).

In 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.

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

Contractual Obligations and Other Commitments

We enter into contracts in

the normal course of business with our CDMOs, CROs and other third parties to support preclinical research studies and testing and other

development activities.

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.

Obligations and Other Commitments

enter into contracts in the normal course of business with our CDMOs, CROs and other third parties to support preclinical research studies

and testing and other development activities.

These contracts are generally cancellable by us.

Payments due upon cancellation consist only of payments for services

provided or expenses incurred, including non-cancellable obligations of our service providers, up to the date of cancellation.

License Obligations and Research Services

November 2020, we entered into an amended and restated development, license and supply agreement with Advaxis, Inc.

(now Ayala Pharmaceuticals,

Inc.) (“Advaxis”), a clinical-stage biotechnology company focused on the development and commercialization of proprietary

Lm ( Listeria monocytogenes )-LLO (Listeriolysin O) cancer immunotherapies.

Pursuant to this agreement, Advaxis granted a

license to us that allows us to utilize Advaxis’ ADXS-HER2 construct patents to develop and commercialize ADXS-HER2, our lead product

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.

As of June 30, 2024, we paid to Advaxis a total of $2,925,000, consisting of (i) the License

Commencement Payment for Milestone 1 and (ii) $1,375,000 for Milestone 2.

Payments towards the License

Commencement Payment have been recorded as licensing expenses in our Statement of Operations and Comprehensive Loss for the year ended

December 31, 2022.

Payments due upon cancellation consist

only of payments for services provided or expenses incurred, including non-cancellable obligations of our service providers, up to the

date of cancellation.

Obligations and Research Services

In November 2020, we entered into an amended and restated development, license and supply agreement with Advaxis, Inc.

Ayala Pharmaceuticals, Inc.) (“Advaxis”), a clinical-stage biotechnology company focused on the development and commercialization

of proprietary Lm ( Listeria monocytogenes )-LLO (Listeriolysin O) cancer immunotherapies.

Pursuant to this agreement, Advaxis

granted a license to us that allows us to utilize Advaxis’ ADXS-HER2 construct patents to develop and commercialize ADXS-HER2,

our lead product 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.

As of September 30, 2024, we paid to Advaxis a total of $2,925,000, consisting of

(i) the License Commencement Payment for Milestone 1 and (ii) $1,375,000 for Milestone 2.

towards the License Commencement Payment have been recorded as licensing expenses in our Statement of Operations and Comprehensive Loss

for the year ended December 31, 2022.

We expect to achieve Milestone 3 in March 2025.

The payment schedule for milestones and corresponding payment

amounts is set forth below.

The payment schedule for milestones and

corresponding payment amounts is set forth below.

OST has secured funding of at least $2,337,500, in the aggregate (paid)

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Cumulative Net Sales of all Licensed Products in excess of $100,000,000

All milestone payments are

non-creditable and non-refundable and are due and payable upon the achievement of the milestone, regardless of any failure by us to provide

notice to Advaxis of such achievement.

In addition to the payments

upon achievement of the milestones listed in the above payment schedule, we are required to pay to Advaxis (i) a percentage in the high

single digits to low double digits of (a) upfront sublicense fees or (b) clinical or regulatory milestone payment amounts, paid

by a sublicensee to us in consideration of a sublicense grant to such sublicensee, and (ii) a quarterly royalty of a percentage in

the high single digits to low double digits of net sales of our products containing the ADXS-HER2 constructs.

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

to facilitate the treatment of cancer.

Pursuant to this agreement, BlinkBio granted a license to us that allows us to utilize BlinkBio’s

proprietary technology to develop, manufacture and commercialize certain of our products.

BlinkBio granted us an exclusive license for

tunable drug conjugates that are directed towards, binds to or modifies the folate receptor alpha and a co-exclusive license for tunable

drug conjugates that are directed towards, binds to or modifies any target other than the folate receptor alpha, such as HER2.

Under the terms of the agreement,

we are required to pay to BlinkBio (i) an upfront, non-refundable, non-creditable license fee of $300,000 (the “Up-Front Fee”),

(ii) a royalty of 6% of net sales of our products that were made using BlinkBio’s proprietary technology, subject to potential

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

As of June 30, 2024, we had

paid the Up-Front Fee.

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

milestone payments are non-creditable and non-refundable and are due and payable upon the achievement of the milestone, regardless of

any failure by us to provide notice to Advaxis of such achievement.

addition to the payments upon achievement of the milestones listed in the above payment schedule, we are required to pay to Advaxis (i)

a percentage in the high single digits to low double digits of (a) upfront sublicense fees or (b) clinical or regulatory milestone

payment amounts, paid by a sublicensee to us in consideration of a sublicense grant to such sublicensee, and (ii) a quarterly royalty

of a percentage in the high single digits to low double digits of net sales of our products containing the ADXS-HER2 constructs.

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

therapies designed to facilitate the treatment of cancer.

Pursuant to this agreement, BlinkBio granted a license to us that allows us

to utilize BlinkBio’s proprietary technology to develop, manufacture and commercialize certain of our products.

BlinkBio granted

us an exclusive license for tunable drug conjugates that are directed towards, binds to or modifies the folate receptor alpha and a co-exclusive

license for tunable drug conjugates that are directed towards, binds to or modifies any target other than the folate receptor alpha,

such as HER2.

the terms of the agreement, we are required to pay to BlinkBio (i) an upfront, non-refundable, non-creditable license fee of $300,000

(the “Up-Front Fee”), (ii) a royalty of 6% of net sales of our products that were made using BlinkBio’s proprietary

technology, subject to potential reductions on such royalty, and (iii) certain amounts based on the achievement of the milestones

described in the payment schedule below.

of September 30, 2024, we had paid the Up-Front Fee.

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

Milestone Bearing Event

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Regulatory Approval in the first of the United States, within the European Union or within the United Kingdom

We are required to make the

above cash payments to BlinkBio within 30 days of the achievement of each milestone with respect to the first product to attain each

such milestone, except that the first milestone only applies to our first product candidate.

The aggregate amount of payments relating

to milestones 2 through 6 payable thereunder cannot exceed $22,375,000.

In connection with the license

agreement, we also agreed to issue the BlinkBio Convertible Note.

See “— Convertible Notes” above for more information

on the BlinkBio Convertible Note.

are required to make the above cash payments to BlinkBio within 30 days of the achievement of each milestone with respect to the

first product to attain each such milestone, except that the first milestone only applies to our first product candidate.

The aggregate

amount of payments relating to milestones 2 through 6 payable thereunder cannot exceed $22,375,000.

connection with the license agreement, we also agreed to issue the BlinkBio Convertible Note.

See “— Convertible Notes”

above for more information on the BlinkBio Convertible Note.

George Clinical.

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approximately $2,436,928.

For the six months ended June 30, 2024 and year ended December 31, 2023, we paid $219,200 and $921,300, respectively,

to George Clinical.

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

For the nine months ended September 30, 2024 and year ended December 31, 2023, we paid $345,836 and $921,300,

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 below.

George Clinical Payment Schedule

Clinical Payment Schedule

Service Fee Advance (paid)

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Split monthly

George Clinical tracks and

invoices us for the number of task units completed and pass-through costs are invoiced each month in arrears based on actual costs without

Clinical tracks and invoices us for the number of task units completed and pass-through costs are invoiced each month in arrears based

on actual costs without mark-up.

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

As of June 30, 2024, the balance due

to George Clinical was $663,622.

Off-Balance Sheet Arrangements

We did not have during the

periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules and regulations of the SEC.

Recent Accounting Pronouncements

A description of recently

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.

The JOBS Act permits an emerging

growth company such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable

to public companies until those standards would otherwise apply to private companies.

We have elected to avail ourselves of the extended

transition period for complying with new or revised financial accounting standards.

We will remain an emerging

growth company until the earliest of (i) the last day of our first fiscal year in which we have total annual gross revenues

of $1.235 billion or more;

(ii) the date on which we are deemed to be a “large accelerated filer” under the rules

of the SEC with at least $700.0 million of outstanding equity securities held by non-affiliates;

(iii) the date on which we

have issued more than $1.0 billion in non-convertible debt securities during the previous three years;

or (iv) the last day

of our fiscal year following the fifth anniversary of the date of the completion of our initial public offering.

Quantitative and Qualitative Disclosures

About Market Risk.

Not applicable.

As of September

30, 2024, the balance due to George Clinical was $295,082.

Sheet Arrangements

did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined in the rules

and regulations of the SEC.

Accounting Pronouncements

description of recently 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.

JOBS Act permits an emerging growth company such as us to take advantage of an extended transition period to comply with new or revised

accounting standards applicable to public companies until those standards would otherwise apply to private companies.

We have elected

to avail ourselves of the extended transition period for complying with new or revised financial accounting standards.

will remain an emerging growth company until the earliest of (i) the last day of our first fiscal year in which we have total

annual gross revenues of $1.235 billion or more;

(ii) the date on which we are deemed to be a “large accelerated filer”

under the rules of the SEC with at least $700.0 million of outstanding equity securities held by non-affiliates;

date on which we have issued more than $1.0 billion in non-convertible debt securities during the previous three years;

(iv) the last day of our fiscal year following the fifth anniversary of the date of the completion of our initial public offering.

Quantitative and Qualitative Disclosures About Market Risk.

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