What changed in this filing

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Item 7. Management’s Discussion and Analysis

2026-03-10 compared with 2025-03-05 · 227 added, 212 removed, 38 unchanged (92% of the section changed)

Management’s Discussion and Analysis of Financial

Condition and Results of Operations

You should read the following

discussion and analysis of our financial condition and results of operations together with our financial statements and related notes

appearing elsewhere in this Annual Report on Form 10-K.

Some of the information contained in this discussion and analysis or set forth

elsewhere in this Annual Report on Form 10-K, including information with respect to our plans and strategy for our business and related

financing, includes forward-looking statements that involve risks and uncertainties.

As a result of many factors, including those factors

set forth in the “Risk Factors” section of this document, our actual results could differ materially from the results described

in, or implied by, the forward-looking statements contained in the following discussion and analysis.

We are a New York City based

clinical-stage biopharmaceutical company committed to advancing transformative therapies for the treatment of cancer and rare diseases.

We were founded on the principle of applying modern scientific, regulatory or manufacturing advancements to established mechanisms in

order to create new development opportunities.

We prioritize creativity, diverse perspectives, integrity and tenacity to expedite our

goal of bringing life-changing therapies to people with limited treatment options.

Our portfolio includes two

development programs utilizing TARA-002, an investigational cell therapy based on the broad immunopotentiator, OK-432, which was originally

granted marketing approval by the Japanese Ministry of Health and Welfare as an immunopotentiating cancer therapeutic agent.

therapy is currently approved in Japan and Taiwan for lymphatic malformations, or LMs, and multiple oncologic indications.

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

should read the following discussion and analysis of our financial condition and results of operations together with our financial statements

and related notes appearing elsewhere in this Annual Report on Form 10-K.

Some of the information contained in this discussion and analysis

or set forth elsewhere in this Annual Report on Form 10-K, including information with respect to our plans and strategy for our business

and related financing, includes forward-looking statements that involve risks and uncertainties.

As a result of many factors, including

those factors set forth in the “Risk Factors” section of this document, our actual results could differ materially from the

results described in, or implied by, the forward-looking statements contained in the following discussion and analysis.

are a New York City based clinical-stage biopharmaceutical company committed to advancing transformative therapies for the treatment

of cancer and rare diseases.

We were founded on the principle of applying modern scientific, regulatory or manufacturing advancements

to established mechanisms in order to create new development opportunities.

We prioritize creativity, integrity and tenacity to expedite

our goal of bringing life-changing therapies to people with limited treatment options.

portfolio includes two development programs utilizing TARA-002, an investigational cell therapy based on the broad immunopotentiator,

OK-432, which was originally granted marketing approval by the Japanese Ministry of Health and Welfare as an immunopotentiating cancer

therapeutic agent.

This cell therapy is currently approved in Japan and Taiwan for LMs and multiple oncologic indications.

We have secured

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was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432 (marketed as Picibanil®

in Japan by Chugai Pharmaceutical Co., Ltd., or Chugai Pharmaceutical).

We are currently developing TARA-002 in non-muscle invasive bladder

cancer, or NMIBC, and in LMs.

We are also pursuing intravenous,

or IV, Choline Chloride, an investigational phospholipid substrate replacement therapy, for patients receiving parenteral support, or

PS, which includes both nutrition and fluids.

Choline is a known important substrate for phospholipids that are critical for healthy liver

function and also plays an important role in modulating gene expression, cell membrane signaling, brain development and neurotransmission,

muscle function and bone health.

PS patients are unable to synthesize choline from enteral nutrition sources, and there are currently

no available PS formulations containing choline.

For additional information regarding our various clinical trials

and programs, see “Item 1.

Business.” We have devoted substantial efforts to the development of these programs and do not

have any approved products and have not generated any revenue from product sales.

Neither TARA-002 nor IV Choline Chloride have been approved

for use for any indications.

We do not expect to generate revenues in the near-term, and it is possible we may never generate revenues

in the future.

To finance our current strategic plans, including the conduct of ongoing and future clinical trials and further research

and development costs, we will need to raise additional capital.

Management’s Discussion and Analysis of Financial

Condition and Results of Operations—Liquidity and Capital Resources” for additional information about our liquidity and capital

in Japan by Chugai Pharmaceutical).

We are currently developing TARA-002 in NMIBC and in LMs.

We are also pursuing IV

Choline Chloride, an investigational phospholipid substrate replacement therapy, for patients receiving PS which includes both nutrition

Choline is a known important substrate for phospholipids that are critical for healthy liver function and also plays an important

role in modulating gene expression, cell membrane signaling, brain development, neurotransmission, muscle function and bone health.

patients are unable to synthesize choline from enteral nutrition sources, and there are currently no available PS formulations containing

Business” for additional information regarding our various clinical trial programs.

We have devoted substantial

efforts to the development of our programs and do not have any approved products and, to date, have not generated any revenues from product

Neither TARA-002 nor IV Choline Chloride have been approved by the FDA or other comparable regulatory authorities for use for any

We do not expect to generate revenues in the near-term, and it is possible we may never generate revenues in the future.

To finance our current strategic plans, including the conduct of ongoing and future clinical trials and further research and development

costs, we will need to raise additional capital.

Management’s Discussion and Analysis of Financial Condition

and Results of Operations—Liquidity and Capital Resources” for additional information about our liquidity and capital

resource needs.

4 unchanged sentences

of, and seek marketing approvals for, our product candidates, prepare for and begin the commercialization of any approved products and

add infrastructure and personnel to support our product development efforts and operations as a public company in the United States.

As a clinical-stage company,

our expenses and results of operations are likely to fluctuate significantly from quarter-to-quarter and year-to-year.

We believe that

our period-to-period comparisons of our results of operations should not be relied upon as indicative of our future performance.

As of December 31, 2024,

we had approximately $170.3 million in cash and cash equivalents, and marketable debt securities.

Financial Overview

Research and Development

Research and development expenses consist primarily of costs incurred

for the development of TARA-002 and IV Choline Chloride, which include personnel-related expenses, including salaries, benefits, travel

and stock-based compensation expense, external expenses incurred under agreements with contract research organizations, or CROs, contract

development and manufacturing organizations, or CDMOs, the cost of acquiring, developing and manufacturing clinical trial materials, clinical

and non-clinical related costs, costs associated with regulatory operations and facilities, depreciation and other expenses, which include

expenses for rent and maintenance of facilities and other supplies.

add infrastructure and personnel to support our product development efforts and operations as a public company in the U.S.

a clinical-stage company, our expenses and results of operations are likely to fluctuate significantly from quarter-to-quarter and year-to-year.

We believe that our period-to-period comparisons of our results of operations should not be relied upon as indicative of our future performance.

of December 31, 2025, we had approximately $197.9 million in unrestricted cash and cash equivalents, and marketable debt securities.

and Development

and development expenses consist primarily of costs incurred for the development of our current and potential future product candidates,

which include personnel-related expenses, including salaries, benefits, travel and stock-based compensation expense, external expenses

incurred under agreements with CROs or CDMOs, the cost of acquiring, developing and manufacturing clinical trial materials, clinical

and non-clinical related costs and costs associated with regulatory operations and facilities, which includes depreciation and other

expenses such as rent, maintenance and other supplies.

and Administrative

General and administrative

General and administrative expenses consist primarily of personnel-related

expenses, including salaries, benefits, travel and stock-based compensation expense, in executive and other administrative functions.

Other general and administrative expenses also include professional fees for business and market development, legal, intellectual property

matters, consulting and accounting services, facility related costs, as well as expenses related to audit, legal, regulatory and tax-related

services associated with maintaining compliance with our Nasdaq listing and Securities and Exchange Commission, or SEC, requirements,

director and officer liability insurance premiums and investor relations costs associated with being a public company.

expenses consist primarily of personnel-related costs, including salaries, benefits, travel expenses and stock-based compensation, for

executive management and other administrative personnel.

General and administrative expenses also include professional fees for legal,

investor relations, consulting, auditing and accounting services, business and market development activities, as well as costs related

to human resources, information technology and facilities.

In addition, these expenses include costs associated with operating as a public

company, such as expenses related to our Nasdaq listing and SEC compliance and director and officer liability insurance premiums.

Income (Expense), net

Other income (expense), net

Other Income (Expense), net consists of interest and investment income

and other income.

Interest and investment income consists of interest and dividend income on our cash and cash equivalents and marketable

debt securities and amortization of premiums and/or accretion of discounts.

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion

and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared

in accordance with accounting principles generally accepted in the United States of America, or GAAP.

The preparation of consolidated

financial statements in conformity with GAAP requires us to make estimates and assumptions that affect the amounts reported in the financial

statements and accompanying notes.

We base our estimates on historical experience and other market-specific or other relevant assumptions

that we believe to be reasonable under the circumstances.

Actual results may differ materially from those estimates or assumptions.

While our significant accounting policies are described in more detail

in the notes to our consolidated financial statements and related notes appearing elsewhere in this Annual Report on this Form 10-K, we

believe the following accounting policies to be most critical to the judgments and estimates used in the preparation of our financial

Our critical accounting policy is the accounting for prepaid and accrued

research and development expenses.

Research and Development Prepaid and Accrued

We record accruals for estimated costs of research, preclinical,

non-clinical, clinical and manufacturing development within accrued expenses which are significant components of research and development

A substantial portion of our ongoing research and development activities are conducted by third-party service providers.

accrue costs incurred under these third-party arrangements based on estimates of actual work completed in accordance with the respective

We determine the estimated costs to accrue through discussions with internal personnel and our external service providers

as to the percentage of completion of the services and the agreed-upon fees to be paid for such services.

Payments made to third parties

under these arrangements in advance of performance of the related services are recorded as prepaid expenses until the services are rendered.

Results of Operations

Comparison of the Years Ended December 31,

2024 and 2023

The following table summarizes our results of operations (in thousands):

For the Years Ended

consists of interest and investment income (expense) and other income (expense).

Interest and investment income (expense) consists of

interest and dividend income on our cash and cash equivalents and marketable debt securities and amortization of premiums and/or accretion

of discounts.

Other income (expense) may also include non-operating items, such as refundable tax credits and other miscellaneous income

not related to our core operating activities.

Accounting Policies and Significant Judgments and Estimates

management’s discussion and analysis of our financial condition and results of operations is based on our consolidated financial

statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America, or

The preparation of consolidated financial statements in conformity with GAAP requires us to make estimates and assumptions that

affect the amounts reported in the financial statements and accompanying notes.

We base our estimates on historical experience and other

market-specific or other relevant assumptions that we believe to be reasonable under the circumstances.

Actual results may differ materially

from those estimates or assumptions.

our significant accounting policies are described in more detail in the notes to our consolidated financial statements and related notes

appearing elsewhere in this Annual Report on this Form 10-K, we believe the following accounting policies to be most critical to the

judgments and estimates used in the preparation of our financial statements.

Our critical accounting policy

is the accounting for research and development prepaid and accrued expenses.

and Development Prepaid and Accrued Expenses

record accruals for estimated costs of research, preclinical, non-clinical, clinical and manufacturing development within accrued expenses

which are significant components of research and development expenses.

A substantial portion of our ongoing research and development

activities are conducted by third-party service providers.

We accrue costs incurred under these third-party arrangements based on estimates

of actual work completed in accordance with the respective agreements.

We determine the estimated costs to accrue through discussions

with internal personnel and our external service providers as to the percentage of completion of the services and the agreed-upon fees

to be paid for such services.

Payments made to third parties under these arrangements in advance of performance of the related services

are recorded as prepaid expenses until the services are rendered.

of Operations

of the Years Ended December 31, 2025 and 2024

following table summarizes our results of operations (in thousands):

the Years Ended

Operating expenses:

Research and development

General and administrative

Total operating expenses

and administrative

operating expenses

Income (Loss) from operations

Other income (expense), net:

Interest and investment income

Other income (expense), net

Interest and investment

income (expense)

income (expense), net

Net income (loss)

Research and development

The following table summarizes our research and development expenses

(in thousands):

For the Years Ended

and development expenses

following table summarizes our research and development expenses (in thousands):

the Years Ended

Direct expenses by product candidate:

TARA-002 in NMIBC

TARA-002 in LM

IV Choline Chloride

Total direct expenses by product candidate

Indirect research and development expenses

Total research and development expenses

Research and development expenses were $31.7 million for the year ended

December 31, 2024, which represented an increase of approximately $6.7 million as compared to the year ended December 31, 2023.

This increase

was primarily due to a $6.1 million increase in direct expenses for our product candidates and a $0.6 million increase in indirect expenses.

The increase in indirect expenses was primarily due to a $1.0 million increase in personnel-related expenses offset by a decrease of $0.3

million in indirect clinical manufacturing expenses.

TARA-002 in LMs

Choline Chloride

Total direct expenses by

product candidate

Indirect research and

development expenses

Research and development

expenses were $42.6 million for the year ended December 31, 2025, which represented an increase of approximately $10.9 million as compared

to the year ended December 31, 2024.

This increase was primarily due to a $10.1 million increase in direct expenses for our product candidates

and a $0.9 million increase in indirect expenses.

The increase in direct expenses was primarily due to site expansion and enrollment efforts

for the ADVANCED-2 trial for NMIBC, start-up costs related to the ADVANCED-3 trial for NMIBC, as well as start-up and enrollment costs

related to the THRIVE-3 trial for IV Choline Chloride.

The increase in indirect expenses was primarily due to a $2.0 million increase

in personnel-related expenses offset by a decrease of $1.1 million in research and development expenses not directly attributable to one

specific product candidate.

and administrative expenses

following table summarizes our general and administrative expenses (in thousands):

the Years Ended

Personnel-related

expenses, including stock-based compensation

Other general and administrative

General and administrative

General and administrative expenses were $17.5 million for the year

ended December 31, 2024, which represented a decrease of approximately $1.2 million as compared to the year ended December 31, 2023.

decrease was primarily due to a net decrease of $1.2 million in personnel-related expenses.

Other income (expense),

Other income (expense), net was $4.6 million for the year ended December

31, 2024, which represented an increase of approximately $1.4 million as compared to the year ended December 31, 2023, due primarily to

higher investment returns on a higher invested balance as well as a $0.4 million increase in other income.

Liquidity and Capital Resources

As of December 31, 2024 and 2023, our cash and cash equivalents, and

marketable debt securities were $170.3 million and $65.6 million, respectively.

We have not generated revenues since our inception and

have incurred net losses of approximately $44.6 million and $40.4 million for the years ended December 31, 2024 and 2023, respectively.

As of December 31, 2024, we had working capital of approximately $161.2 million and stockholder’s equity of approximately $167.1

During the year ended December 31, 2024, cash flows used in operating activities were approximately $35.8 million, consisting

primarily of a net loss of approximately $44.6 million, which includes non-cash activities of approximately $4.8 million, inclusive of

$4.1 million in stock-based compensation expense, as well as working capital adjustments of $4.0 million.

Since inception, we have met

our liquidity requirements principally through the sale of our common stock, preferred stock and pre-funded warrants in private placements

and public offerings.

expenses were $21.9 million for the year ended December 31, 2025, which represented an increase of approximately $4.5 million as compared

to the year ended December 31, 2024.

This increase was primarily due to an increase of $2.3 million in personnel-related expenses, as

well as an increase of $2.1 million in other general and administrative expenses primarily related to professional and consulting services.

income (expense), net

Other income (expense), net

was $7.1 million for the year ended December 31, 2025, which represented an increase of approximately $2.6 million as compared to the

year ended December 31, 2024.

The $2.2 million increase in interest and investment income (expense) is due primarily to investment returns

on a higher invested balance.

The $0.3 million increase in other income (expense) is due to an increase in refundable tax credits received

in the year ended December 31, 2025.

and Capital Resources

of December 31, 2025 and 2024, our unrestricted cash and cash equivalents, and marketable debt securities were $197.9 million and $170.3

million, respectively.

We have not generated revenues since our inception and have incurred net losses of approximately $57.4 million

and $44.6 million for the years ended December 31, 2025 and 2024, respectively.

As of December 31, 2025, we had working capital of approximately

$148.6 million and stockholder’s equity of approximately $196.4 million.

During the year ended December 31, 2025, cash flows used

in operating activities were approximately $56.4 million, consisting primarily of a net loss of approximately $57.4 million, which includes

non-cash activities of approximately $4.0 million, inclusive of $3.8 million in stock-based compensation expense, as well as cash used

for changes in operating assets and liabilities of $2.9 million.

Since inception, we have met our liquidity requirements principally

through the sale of our common stock, preferred stock and pre-funded warrants in private placements of securities and public offerings

of securities.

In addition, we may receive proceeds upon the exercise of the common warrants issued in the April 2024 private placement

described below.

On November 3, 2023, we filed a shelf registration statement on Form

S-3, or the Shelf Registration Statement, which became effective in November 2023.

The Shelf Registration Statement permits the offering,

issuance and sale by us of up to a maximum aggregate offering price of $300.0 million of common stock, preferred stock, debt securities

and warrants in one or more offerings and in any combination.

In December 2024, we sold and issued approximately $100.1 million in gross

proceeds of common stock and pre-funded warrants in a public offering, or the December 2024 Public Offering, under the Shelf Registration

November 3, 2023, we filed a shelf registration statement on Form S-3, or the Shelf Registration Statement, which became effective in

November 2023.

The Shelf Registration Statement permits the offering, issuance and sale by us of up to a maximum aggregate offering price

of $300.0 million of common stock, preferred stock, debt securities and warrants in one or more offerings and in any combination.

December 2024, we sold and issued approximately $102.8 million in gross proceeds of common stock and pre-funded warrants in a public

offering, or the December 2024 Public Offering, under the Shelf Registration Statement.

The net proceeds were approximately $95.9 million.

In January 2025, the underwriters partially exercised their option, or the

Underwriters’ Option, to purchase a portion of the additional shares of common stock pursuant to the underwriting agreement,

or the Underwriting Agreement, which resulted in gross proceeds of approximately $2.7 million and net proceeds of approximately $2.5 million.

In December 2025, we sold and issued approximately $86.3 million in gross proceeds of common stock in a public offering, or the December

2025 Public Offering, under the Shelf Registration Statement.

The net proceeds were approximately $80.4 million.

In April 2024, the Company entered into a private placement transaction,

1 unchanged sentence

warrants to certain purchasers.

At the close of the April 2024 Private Placement, the Company received net proceeds of approximately $42.0

million after deducting placement agent fees and offering expenses.

We are in the business of

developing biopharmaceuticals and have no current or near-term revenues.

We have incurred substantial clinical and other costs in our

drug development efforts.

We will need to raise additional capital in order to fully realize management’s plans.

We believe that our current

financial resources, as of the date of the issuance of our consolidated financial statements included elsewhere in this Annual Report

on this Form 10-K, are sufficient to satisfy our estimated liquidity needs for at least 12 months.

At the close of the April 2024 Private Placement, the Company received approximately $45.0 million in

gross proceeds.

The net proceeds were approximately $42.0 million.

Additionally, as part of the April 2024 Private Placement, purchasers

were offered common warrants.

Common warrants exercised as of December 31, 2025 have resulted in $3.8 million in proceeds and, if exercised,

proceeds from the remaining common warrants as of December 31, 2025 could result in an additional $53.1 million.

are in the business of developing biopharmaceuticals and have no current or near-term revenues.

We have incurred substantial clinical

and other costs in our drug development efforts.

We will need to raise additional capital in order to fully realize management’s

believe that our current financial resources are sufficient to satisfy our estimated liquidity needs for at least 12 months from the

date of issuance of our consolidated financial statements included elsewhere in this Annual Report on this Form 10-K.

As a result of volatility

8 unchanged sentences

Further, a recession or market correction, supply chain

disruptions and/or continued inflation could materially affect our business and the value of our common stock.

The following table summarizes our sources and uses of cash (in thousands):

For the Years Ended

Net cash provided by/(used in) operating activities

disruptions and/or inflation could materially affect our business and the value of our common stock.

following table summarizes our sources and uses of cash (in thousands):

the Years Ended

Net cash provided by (used in)

operating activities

Net cash provided by (used in) investing activities

Net cash provided by/(used in) financing activities

Net increase/(decrease) in cash and cash equivalents, and restricted cash

Comparison of the Years Ended December 31, 2024 and 2023

Net cash provided by (used in) operating activities was approximately

$(35.8) million for the year ended December 31, 2024 compared to approximately $(37.6) million for the year ended December 31, 2023.

decrease of approximately $1.7 million in cash used in operating activities was primarily driven by a decrease in working capital adjustments,

primarily related to changes in prepaid expenses and other current assets, accounts payable, and accrued expenses resulting from the timing

of payments to our service providers of $8.1 million, offset in part by an increase in net loss of $4.2 million and by a $2.2 million

decrease in non-cash items, consisting principally of stock-based compensation expense.

Net cash provided by

(used in) financing activities

Net increase (decrease)

in cash and cash equivalents, and restricted cash

of the Years Ended December 31, 2025 and 2024

Net cash provided by (used

in) operating activities was approximately $(56.4) million for the year ended December 31, 2025 compared to approximately $(35.8) million

for the year ended December 31, 2024.

The increase of approximately $20.6 million in cash used in operating activities was primarily driven

by an increase in net loss of $12.8 million, an increase in cash used for operating assets and liabilities, primarily related to changes

in prepaid expenses and other current assets, accounts payable, and accrued expenses and other current liabilities, resulting from the

timing of payments to our service providers of $6.9 million, and by a decrease in non-cash items, consisting principally of accretion

of discount on marketable debt securities and stock-based compensation expense of $0.8 million.

Net cash provided by (used

in) investing activities was approximately $(139.5) million for the year ended December 31, 2025 compared to approximately $19.2 million

for the year ended December 31, 2024.

The decrease of $34.0 million resulted primarily from an increase of $17.2 million of marketable

debt securities purchased as well as a decrease of $16.7 million of proceeds from marketable debt securities matured.

Net cash provided by (used in) financing activities was $139.9 million

for the year ended December 31, 2024 compared to $(0.1) million for the year ended December 31, 2023.

The increase of approximately $140.0

million resulted primarily from the net proceeds of the December 2024 Public Offering of $94.0 million and the April 2024 Private Placement

of $42.0 million, as well as proceeds from the exercise of common warrants of $3.8 million.

Contractual and Other Obligations

Operating lease obligations

Our operating lease obligations

primarily consist of lease payments on our corporate headquarters in New York, New York, as well as lease payments for our development

laboratory, a manufacturing facility and an additional manufacturing space, all located in North America which are described in further

detail in Note 9 of our consolidated financial statements included in this Annual Report on Form 10-K.

Future contractual payments on

operating lease obligations due within one year of December 31, 2024 are $1.4 million, and future contractual payments on operating lease

obligations due greater than one year from December 31, 2024 are $3.7 million.

Other obligations

From time to time, we enter

into certain types of contracts that contingently require us to indemnify parties against third-party claims, supply agreements, and agreements

with directors and officers.

The terms of such obligations vary by contract and in most instances a maximum dollar amount is not explicitly

stated therein.

Generally, amounts under these contracts cannot be reasonably estimated until a specific claim is asserted, thus no liabilities

have been recorded for these obligations on our consolidated balance sheet for the periods presented.

We enter into contracts in

the normal course of business with CROs and clinical sites for the conduct of clinical trials, non-clinical research studies, professional

consultants for expert advice and other vendors for clinical supply manufacturing or other services.

These contracts generally provide

for termination on notice, and therefore are cancelable contracts.

Certain of these agreements

require us to pay milestones to such third parties upon achievement of certain development, regulatory or commercial milestones as further

described in Note 10 of our consolidated financial statements included in this Annual Report on Form 10-K.

Amounts related to contingent

milestone payments are not considered contractual obligations as they are contingent on the successful achievement of certain development,

regulatory approval and commercial milestones, which may not be achieved.

We also have obligations

to make future payments to third parties that become due and payable on the achievement of certain milestones, including future payments

to third parties with whom we have entered into research, development and commercialization agreements.

We have not included these commitments

on our consolidated balance sheet for the periods presented because the achievement and timing of these milestones is not fixed and determinable.

The increase in cash used of $158.7 million resulted primarily from an increase in purchases of

marketable debt securities of $175.2 million offset slightly by an increase in proceeds from marketable debt securities matured and redeemed

of $16.6 million.

Net cash provided by (used

in) financing activities was $82.7 million for the year ended December 31, 2025 compared to $139.9 million for the year ended December

The decrease of approximately $57.2 million resulted primarily from less capital being raised from public and private offerings

in the year ended December 31, 2025 as compared to the year ended December 31, 2024 of $53.1 million.

During the year ended December 31,

2025, cash provided by financing activities related to public offerings was $82.9 million as compared to December 31, 2024 where cash

provided by financing activities related to private and public offerings was $136.0 million.

Additionally, during the year ended December

31, 2024 cash provided by financing activities related to the exercise of common warrants was $3.8 million.

and Other Obligations

lease obligations

operating lease obligations primarily consist of lease payments on our corporate headquarters in New York, New York, as well as lease

payments for our development laboratory, a manufacturing facility and an additional manufacturing space, all located in North America

which are described in further detail in Note 9 of our consolidated financial statements included in this Annual Report on Form 10-K.

Future contractual payments on operating lease obligations due within one year of December 31, 2025 are $1.4 million, and future contractual

payments on operating lease obligations due greater than one year from December 31, 2025 are $2.2 million.

time to time, we enter into certain types of contracts that contingently require us to indemnify parties against third-party claims,

supply agreements, and agreements with directors and officers.

The terms of such obligations vary by contract and in most instances a

maximum dollar amount is not explicitly stated therein.

Generally, amounts under these contracts cannot be reasonably estimated until

a specific claim is asserted, thus no liabilities have been recorded for these obligations on our consolidated balance sheet for the

periods presented.

enter into contracts in the normal course of business with CROs and clinical sites for the conduct of clinical trials, non-clinical research

studies, professional consultants for expert advice and other vendors for clinical supply manufacturing or other services.

These contracts

generally provide for termination on notice, and therefore are cancelable contracts.

of these agreements require us to pay milestones to such third parties upon achievement of certain development, regulatory or commercial

milestones as further described in Note 10 of our consolidated financial statements included in this Annual Report on Form 10-K.

related to contingent milestone payments are not considered contractual obligations as they are contingent on the successful achievement

of certain development, regulatory approval and commercial milestones, which may not be achieved.

also have obligations to make future payments to third parties that become due and payable on the achievement of certain milestones,

including future payments to third parties with whom we have entered into research, development and commercialization agreements.

have not included these commitments on our consolidated balance sheet for the periods presented because the achievement and timing of

these milestones is not fixed and determinable.

Quantitative and Qualitative Disclosures About Market Risk .

No disclosure required.

disclosure required.

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

What changed 10-K

Item 7. Management’s Discussion and Analysis