What changed in this filing

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Item 1. Financial Statements

2025-05-14 compared with 2024-11-13 · 582 added, 711 removed, 695 unchanged (65% of the section changed)

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(In thousands, except for share and per share

September 30,

Current assets:

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Property, plant and equipment, net

Liabilities and stockholders’ (deficit) equity

Liabilities and stockholders’ equity

Current liabilities:

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Commitments and contingencies (Note 6)

Stockholders’ (deficit) equity:

Series A-2 Prime preferred stock, $ 0.001 par value per share – 43,649 Series A-2 shares authorized at December 31, 2023 and 21,388.01 Series A-2 Prime shares authorized at September 30, 2024;

43,649 Series A-2 shares outstanding at December 31, 2023 and 11,111.24 Series A-2 Prime shares outstanding at September 30, 2024

Series B-2 preferred stock, $ 0.001 par value per share – zero Series B-2 shares authorized at December 31, 2023 and 7,882 Series B-2 Prime shares authorized at September 30, 2024;

zero Series B-2 shares outstanding at December 31, 2023 and 7,882 Series B-2 shares outstanding at September 30, 2024

Stockholders’ equity:

Series A-2 Prime preferred stock, $ 0.001 par value per share – 21,338.01 Series A-2 Prime shares authorized at December 31, 2024 and March 31, 2025;

6,150.21 and 5,464.21 Series A-2 Prime shares issued and outstanding at December 31, 2024 and March 31, 2025, respectively

Series B-2 preferred stock, $ 0.001 par value per share – 7,882 Series B-2 shares authorized at December 31, 2024 and March 31, 2025;

3,000 Series B-2 shares issued and outstanding at December 31, 2024 and March 31, 2025

Preferred stock:

$ 0.001 par value per share— 10,000,000 shares authorized at December 31, 2023 and September 30, 2024;

zero shares issued and outstanding at December 31, 2023 and September 30, 2024

Common stock, $ 0.001 par value per share – 200,000,000 shares authorized at December 31, 2023 and 400,000,000 shares authorized at September 30, 2024;

34,756,049 and 97,858,406 shares issued and outstanding at December 31, 2023 and September 30, 2024, respectively

$ 0.001 par value per share — 9,846,891 shares authorized at December 31, 2024 and March 31, 2025;

zero shares issued and outstanding at December 31, 2024 and March 31, 2025

Common stock, $ 0.001 par value per share – 400,000,000 shares authorized at December 31, 2024 and March 31, 2025;

113,842,364 and 119,749,743 shares issued and outstanding at December 31, 2024 and March 31, 2025, respectively

Additional paid-in capital

Accumulated deficit

Total stockholders’ (deficit) equity

Total liabilities and stockholders’ (deficit) equity

Total stockholders’ equity

Total liabilities and stockholders’ equity

See accompanying notes to the financial statements

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Three Months Ended

September 30,

Nine Months Ended

September 30,

Licensing revenues

Operating expenses:

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Total other income (expenses)

Deemed dividends to Series A-1 preferred stockholders

Cash dividends to Series B-1 preferred stockholders

Net loss attributable to common stockholders

Net loss per share attributable to common stockholders, basic and diluted

Weighted-average shares outstanding used in computing net loss per share, basic and diluted

Net (loss) income

Net (loss) income attributable to common stockholders, basic

Net loss attributable to common stockholders, diluted

Net (loss) income per share:

Weighted-average shares outstanding:

See accompanying notes to the financial statements

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Statements of Mezzanine Equity and Stockholders’

(Deficit) Equity

(In thousands, except share amounts)

Series A-2 Prime

Preferred Stock

Stockholders’

Balance at December 31, 2023

Issuance of Series A-1 preferred stock, net of issuance costs and allocated fair value of warrant liability

Deemed dividends on Series A-1 preferred stock

Issuance of Series B-1 preferred stock, net of issuance costs

Dividends on Series B-1 preferred stock

Exchange of Series A-2 preferred stock for Series A-2 Prime preferred stock

Conversion of Series A-2 Prime preferred stock into common stock

Issuance of common stock for exercise of options

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Balance at March 31, 2024

Deemed dividends on Series A-1 preferred stock

Issuance of common stock for exercise of options

Stock-based compensation expense

Balance at June 30, 2023

Deemed dividends on Series A-1 preferred stock

Issuance of Series A-2 preferred stock and common stock upon conversion of Series A-1 preferred stock

Issuance of common stock from exercise of options

Stock-based compensation expense

Balance at September 30, 2023

Preferred Stock

Series A-2 Prime

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Preferred Stock

Stockholder’s

Balance at December 31, 2024

Issuance of Series B-1 preferred stock, net of issuance costs

Dividends on Series B-1 preferred stock

Exchange of Series A-2 preferred stock for Series A-2 Prime preferred stock

$ ( 101,270 )

Conversion of Series A-2 Prime preferred stock into common stock

Issuance of common stock for exercise of options

Issuance of common stock for cash, net of issuance costs

Stock-based compensation expense

Balance at March 31, 2025

Dividends Paid on Series B-1 preferred stock

Conversion of Series A-2 Prime preferred stock into common stock

Issuance of common stock for exercise of options

Stock-based compensation expense

Balance at June 30, 2024

Issuance of Series B-2 preferred stock and common stock upon conversion of Series B-1 preferred stock

Issuance of common stock for exercise of options

Stock-based compensation expense

Balance at September 30, 2024

$ ( 100,700 )

See accompanying notes to the financial statements

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(In thousands)

Nine Months Ended

September 30,

Three Months Ended

Cash flows from operating activities

Net (loss) income

Adjustments to reconcile net loss to net cash used in operating activities:

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Proceeds from issuance of Series B-1 preferred stock

Issuance costs related to issuance of Series A-1 preferred stock and warrants

Proceeds from issuance of Series A-1 preferred stock and warrants

Dividends on preferred stock

Commissions paid on secondary public offering

Proceeds from secondary public offering

Net cash provided by financing activities

Net increase in cash and cash equivalents

Net increase (decrease) in cash and cash equivalents

Cash and cash equivalents at the beginning of the period

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Accrued dividends on preferred stock

Fair value of warrants issued in connection with the issuance of preferred stock

Issuance of Series A-2 preferred stock and common stock upon conversion

of Series A-1 preferred stock

Issuance of Series B-2 preferred stock and common stock upon conversion

of Series B-1 preferred stock

Deferred insurance charges included in prepaid expenses and other current assets

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was incorporated in the State of Delaware on August 18, 2016 .

The Company was dormant until July 2017 when it began evaluating a number

of drug candidates for in-licensing.

The Company was dormant until July 2017 when it began evaluating several

drug candidates for in-licensing.

The Company in-licensed the drug candidate UNI

494 from Sphaera Pharma Pte.

Ltd, a Singapore-based corporation, (“Sphaera”) (Note 3).

UNI 494 is a pro-drug of Nicorandill

that is being developed as a treatment for acute kidney injury.

In September 2018, the Company purchased a second

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Kidney Disease (“CKD”).

In 2017, the Company in-licensed the drug candidate UNI 494 from Sphaera

Ltd, a Singapore-based corporation, (“Sphaera”) (Note 3).

UNI 494 is a pro-drug of nicorandil that is being developed

as a treatment for acute kidney injury.

The Company continues to evaluate the licensing

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revenue as well as product sales.

The Company has not generated any licensing revenue during the nine months ended September 30, 2024.

The Company has incurred operating losses and

negative cash flows from operations since inception and expects to continue to incur negative cash flows from operations in the future.

As the Company increases its research and development activities, the operating losses are expected to increase.

As the Company continues its research and development activities, the operating losses are expected to increase.

The Company has historically

relied on private equity offerings, debt financing and loans from a stockholder to fund its operations.

As of December 31, 2023 and September

relied on equity offerings, debt financing and loans from a stockholder to fund its operations.

As of December 31, 2024, and March 31,

2025, the Company had an accumulated deficit of $ 101.3 million and $ 100.7 million, respectively.

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other commercial planning.

On March 3, 2023, the Company entered into a

securities purchase agreement with certain healthcare-focused institutional investors that may provide up to $ 130.0 million in gross

proceeds through a private placement and that included initial upfront funding of $ 28.0 million in net proceeds.

On March 3, 2023, the Company entered into a securities

purchase agreement with certain healthcare-focused institutional investors that may provide up to $ 130.0 million in gross proceeds through

a private placement and that included initial upfront funding of $ 28.0 million in net proceeds.

On March 13, 2024, the Company entered into a

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a private placement.

Pursuant to the securities purchase agreement, the Company issued institutional investors $ 50.0 million in shares

Pursuant to the securities purchase agreement, the Company issued institutional purchasers $ 50.0 million in shares

of Series B Convertible Preferred Stock.

The Company received $ 46.2 million in net proceeds (net of issuance costs).

The Company received $ 46.2 million in net proceeds.

On November 13, 2024, the Company entered into

a sales agreement, with Guggenheim Securities, LLC pursuant to which, the Company may offer and sell shares of common stock having an

aggregate offering price of up to $ 50.0 million, subject to certain limitations and in accordance with the terms of the sales agreement,

from time to time through or to Guggenheim Securities, acting as sales agent or principal.

During the three months ended March 31, 2025,

the Company sold 4,507,379 shares of common stock at an average price of $ 0.62 per share and paid $ 84 ,000 in commissions, resulting in

net proceeds to the Company of approximately $ 2.7 million.

The Company expects to continue incurring losses

in the future and will be required to raise additional capital in the future to complete its planned clinical trials, pursue product

development initiatives and penetrate markets for the sale of its products.

Management believes that the Company will continue to have

access to capital resources through possible equity offerings, debt financings, corporate collaborations or other means.

no assurance that the Company will be able to obtain additional financing on terms acceptable to the Company, on a timely basis or at

If the Company is unable to secure additional capital, it may be required to curtail any clinical trials and development of new

or existing products and take additional measures to reduce expenses in order to conserve its cash in amounts sufficient to sustain operations

and meet its obligations.

Based on the Company’s current level of expenditures, the Company believes that it has sufficient resources

such that there is not substantial doubt about the ability to continue operations for at least one year after the date that these financial

statements are available to be issued.

in the future and will be required to raise additional capital in the future to complete its planned clinical trials, pursue product development

initiatives and penetrate markets for the sale of its products.

Management believes that the Company will continue to have access to capital

resources through possible equity offerings, debt financing, corporate collaborations, or other means.

There can be no assurance that

the Company will be able to obtain additional financing on terms acceptable to the Company, on a timely basis or at all.

If the Company

is unable to secure additional capital, it may be required to curtail any clinical trials and development of new or existing products

and take additional measures to reduce expenses in order to conserve its cash in amounts sufficient to sustain operations and meet its

Based on the Company’s currently anticipated level of expenditures, the Company believes that current available cash

will not be sufficient to fund planned expenditures and meet obligations through the end of the first quarter of 2026, and there is substantial

doubt about the Company’s ability to continue as a going concern for one year after the date that these financial statements are

available to be issued.

Summary of Significant Accounting Policies

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The accompanying unaudited financial statements

of the Company as of September 30, 2024 have been prepared in accordance with the instructions to Form 10-Q and Article 10 of Regulation

S-X and, accordingly, they do not include all information and footnote disclosures required by accounting principles generally accepted

The Company believes the footnotes and other disclosures made in the financial statements are adequate

for a fair presentation of the results of the interim periods presented.

The financial statements include all adjustments (solely of

a normal recurring nature) which are, in the opinion of management, necessary to make the information presented not misleading.

read these financial statements and the accompanying notes in conjunction with the financial statements and notes thereto included in

the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, filed with the U.S.

Securities and Exchange

Commission (“SEC”) on March 28, 2024.

of the Company as of March 31, 2025 have been prepared in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X

and, accordingly, they do not include all information and footnote disclosures required by accounting principles generally accepted in

The Company believes the footnotes and other disclosures made in the financial statements are adequate for a fair presentation

of the results of the interim periods presented.

The financial statements include all adjustments (solely of a normal recurring nature)

which are, in the opinion of management, necessary to make the information presented not misleading.

You should read these financial statements

and the accompanying notes in conjunction with the financial statements and notes thereto included in the Company’s Annual Report

on Form 10-K for the fiscal year ended December 31, 2024, filed with the U.S.

Securities and Exchange Commission on March 31, 2025.

Use of Estimates

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could have a material effect on future results of operations and financial position.

Significant items subject to such estimates and

assumptions include revenues, stock-based compensation, research contract progress estimates, and the fair value of warrant liabilities.

Actual results may materially differ from those estimates.

Significant items subject to such estimates and assumptions

include, stock-based compensation, research contract progress estimates, incremental borrowing rate for leases, useful life for assets, debt

and equity transactions, and the valuation of warrant liabilities.

Actual results may

materially differ from those estimates.

Revenue Recognition

The Company recognizes revenue in accordance

with Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers (“ASC 606”).

The Company recognizes revenue in accordance with

Accounting Standards Codification (“ASC”) 606, Revenue from Contracts with Customers (“ASC 606”).

applies the five-step model in ASC 606 and recognizes revenue from product sales or services rendered when control of the promised goods

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To achieve this core principle, the Company applies the following five steps:

contract with the client, identify the performance obligations in the contract, determine the transaction price, allocate the transaction

price to performance obligations in the contract and recognize revenues when or as the Company satisfies a performance obligation.

identify the contract

with the client, identify the performance obligations in the contract, determine the transaction price, allocate the transaction price

to performance obligations in the contract and recognize revenues when or as the Company satisfies a performance obligation.

Warrant Liability

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Segment Information

The Company operates and manages its business

as one reportable operating segment.

The Company’s Chief Executive Officer, who is the chief operating decision maker, reviews

financial information on an aggregate basis for purposes of allocating resources and evaluating financial performance.

Company reports its segment information to reflect the manner in which the Company’s

Chief Operating Decision Maker (“CODM”) reviews

and assesses performance.

The Company’s Chief Executive Officer has the responsibility as the CODM to review and assess the performance

of the Company as a whole.

The primary financial measures used by the CODM

to evaluate performance and allocate resources are net (loss) income and operating (loss) income.

The CODM uses net income (loss) and

operating (loss) income to evaluate the performance of the Company’s ongoing operations and as part of the Company’s internal

planning and forecasting processes.

Information on net (loss) income and operating (loss) income is disclosed in the Statements of Operations.

Segment expenses and other segment items are provided to the CODM on the same basis as disclosed in the Statements of Operations.

The CODM does not evaluate performance or allocate

resources based on segment assets, and therefore such information is not presented in the notes to the financial statements.

Risks and Uncertainties

The Company operates in a dynamic and highly

competitive industry and believes that changes in any of the following areas could have a material adverse effect on the Company’s

future financial position, results of operations, or cash flows:

The Company operates in a dynamic and highly competitive

industry and believes that changes in any of the following areas could have a material adverse effect on the Company’s future financial

position, results of operations, or cash flows:

ability to obtain future financing;

advances and trends in new technologies

and industry standards;

advances and trends in new technologies and industry

results of clinical trials;

regulatory approval and market acceptance of the Company’s products;

of sales channels;

development of sales

certain strategic relationships;

litigation or claims against the Company related to intellectual property, product,

regulatory, or other matters;

litigation or claims against the Company related to intellectual property, product, regulatory,

or other matters;

and the Company’s ability to attract and retain employees necessary to support its growth.

The Company’s general business strategy

may be adversely affected by any such economic downturns, volatile business environments and continued unstable or unpredictable economic

and market conditions.

may be adversely affected by any such economic volatile business environments and continued unstable or unpredictable economic and market

Any product candidates developed by the Company

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the Company’s current product candidates or any future product candidates will receive the necessary approvals.

If the Company

is denied approval, approval is delayed or the Company is unable to maintain approval, it could have a materially adverse impact on the

If the Company is

denied approval, approval is delayed or the Company is unable to maintain approval, it could have a materially adverse impact on the Company.

The Company has expended and will continue to

expend substantial funds to complete the research, development and clinical testing of its product candidates.

The Company also will

be required to expend additional funds to establish commercial-scale manufacturing arrangements and to provide for the marketing and

distribution of products that receive regulatory approval.

The Company also will be

required to expend additional funds to establish commercial-scale manufacturing arrangements and to provide for the marketing and distribution

of products that receive regulatory approval.

The Company will require additional funds to commercialize its products.

Company is unable to entirely fund these efforts with its current financial resources.

If adequate funds are unavailable on a timely

basis from operations or additional sources of financing, the Company may have to delay, reduce the scope of or eliminate one or more

of its research or development programs, which would materially and adversely affect its business, financial condition and operations.

The Company is

unable to entirely fund these efforts with its current financial resources.

If adequate funds are unavailable on a timely basis from operations

or additional sources of financing, the Company may have to delay, reduce the scope of or eliminate one or more of its research or development

programs, which would materially and adversely affect its business, financial condition and operations.

The Company is dependent upon the services of

its employees, consultants and other third parties.

Property, Plant and Equipment

Property, plant, and equipment are recorded at

Property and Equipment

Property and equipment are recorded at

cost less accumulated depreciation.

Additions, improvements, and major renewals or replacements that substantially extend the useful

life of an asset are capitalized.

Additions, improvements, and major renewals or replacements that substantially extend the useful life

of an asset are capitalized.

Repairs and maintenance expenditures are expensed as incurred.

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fair value at that time.

At September 30, 2024, management determined there were no impairments of the Company’s property and equipment.

During the three months ended March 31, 2024 and 2025, management determined there were no impairments of the

Company’s property, plant and equipment.

The Company determines whether a contract is,

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term, and lease liabilities represent the Company’s obligation to make lease payments arising from the lease.

Right-of-use assets

and lease liabilities are recognized at lease commencement based upon the estimated present value of unpaid lease payments over the lease

The Company uses its incremental borrowing rate based on the information available at lease commencement in determining the present

value of unpaid lease payments.

The Company records

the right-of-use asset at the amount of the lease liability plus any prepaid rent, amounts paid for lessor-owned leasehold improvements,

and initial direct costs, less any lease incentives and accrued rent.

Lease liabilities are recognized at lease commencement based upon

the estimated present value of unpaid lease payments over the lease term.

The Company uses its incremental borrowing rate based on the

information available at lease commencement in determining the present value of unpaid lease payments.

Fair Value of Financial Instruments

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be received for sale of an asset or paid for transfer of a liability, in an orderly transaction between market participants at the measurement

GAAP establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value.

establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value.

The fair value

hierarchy contains the following levels:

Level 1 — defined as observable inputs based on unadjusted quoted

prices for identical instruments in active markets;

Level 2 — defined as inputs other than Level 1 that are either

directly or indirectly observable in the marketplace for identical or similar instruments in markets that are not active;

Level 3 — defined as unobservable inputs in which little or no

market data exists where valuations are derived from techniques in which one or more significant inputs are unobservable.

The following table summarizes the fair value hierarchy of financial

liabilities measured at fair value as of September 30, 2024 (in thousands):

Level 1 — defined as observable inputs based on unadjusted quoted prices for identical instruments in active markets;

Level 2 — defined as inputs other than Level 1 that are either directly or indirectly observable in the marketplace for identical or similar instruments in markets that are not active;

Level 3 — defined as unobservable inputs

in which little or no market data exists where valuations are derived from techniques in which one or more significant inputs are unobservable.

The fair value of the warrant liability is

determined using a Black Scholes model with parameters including (i) the exercise price of the warrants, (ii) the price of the

underlying security, (iii) the time to expiration, or expected term, (iv) the expected volatility of the underlying security, (v)

the risk-free rate, and (vi) estimated probability assumptions surrounding the achievement by the Company of technical milestones

associated with regulatory and commercial progress.

These valuation techniques involve management’s

estimates and judgment based on unobservable inputs and are classified in Level 3.

The fair value estimates may not be indicative of the

amounts that would be realized in a market exchange.

Additionally, there may be inherent uncertainties or changes in the underlying assumptions

used, which could significantly affect the current or future fair value estimates.

Generally, a significant increase (decrease) in the

probabilities of shareholder approval and the achievement of technical milestones would have resulted in a significantly higher (lower)

fair value measurement;

however, changes in other inputs such as expected term and price of the underlying common stock will have a directionally

opposite impact on fair value measurement.

The following table summarizes the fair value

hierarchy of financial liabilities measured at fair value as of March 31, 2025 (in thousands):

Warrant liability

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are attributable to unobservable inputs (in thousands):

Nine months Ended

September 30,

Fair value at January 1, 2023

Issuance of Warrants (March 3, 2023)

Three Months Ended

Fair value at December 31, 2023