What changed in this filing

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Item 1. Financial Statements

2025-11-14 compared with 2025-08-15 · 176 added, 108 removed, 495 unchanged (36% of the section changed)

3 unchanged sentences

(in thousands, except for share and per share data*)

September 30,

Current assets

23 unchanged sentences

Common stock, $ 0.0001 par value ( 250,000,000 shares authorized);

17,075,338 and 7,302,797 shares issued and 14,619,636 and 7,302,797 outstanding at June 30, 2025, and December 31, 2024, respectively

18,712,224 and 7,302,797 shares issued and 16,111,461 and 7,302,797 outstanding at September 30, 2025, and December 31, 2024, respectively

Additional paid-in capital

16 unchanged sentences

Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

Operating expenses:

Research and development

$ 1,203 $ 1,021 $ 4,927 $ 4,249

Impairment of Intangible Assets

— 9,703 — 9,703

General and administrative

1,315 1,589 4,760 5,972

Total operating expenses

2,518 12,313 9,687 19,924

Loss from operations

( 2,518 ) ( 12,313 ) ( 9,687 ) ( 19,924 )

Other income (expense):

Interest income

187 261 646 314

Interest expense

( 57 ) ( 50 ) ( 126 ) ( 578 )

Foreign exchange gains (losses)

( 418 ) 121 1,308 69

Change in fair value of derivative and warrant liabilities

Total other income, net

( 288 ) 346 1,829 2,481

Loss before income tax benefit

( 2,806 ) ( 11,967 ) ( 7,858 ) ( 17,443 )

Income tax benefit

( 2,806 ) ( 11,590 ) ( 7,858 ) ( 17,062 )

Gain on extinguishment of Series A Convertible Preferred Stock

Deemed dividend on Series A Preferred Stock

— — — ( 299 )

Deemed dividend on Series A Convertible Preferred Stock

— ( 562 ) — ( 562 )

Net loss attributable to common stockholders

$ ( 2,806 ) $ ( 12,152 ) $ ( 7,858 ) $ ( 17,701 )

Net loss per common share, basic and diluted

$ ( 0.19 ) $ ( 7.71 ) $ ( 0.57 ) $ ( 25.33 )

Weighted average common shares outstanding, basic and diluted

14,739,800 1,575,762 13,849,976 698,877

Other comprehensive loss

$ ( 2,806 ) $ ( 11,590 ) $ ( 7,858 ) $ ( 17,062 )

Change in cumulative translation adjustment

158 ( 163 ) ( 1,949 ) ( 282 )

Total comprehensive loss

$ ( 2,648 ) $ ( 11,753 ) $ ( 9,807 ) $ ( 17,344 )

* All common share data has been retroactively adjusted to effect reverse stock splits in 2024 (See Note 1).

1 unchanged sentence

ALLARITY THERAPEUTICS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN REDEEMABLE CONVERTIBLE STOCKHOLDERS ’ EQUITY (DEFICIT)

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

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS ’ EQUITY (DEFICIT)

For the three and nine months ended September 30, 2025 and 2024

(in thousands, except for share data*)

Series A Convertible

Stockholders’

Preferred Stock

Comprehensive

31 unchanged sentences

— — — — 1,062,822 3 27,649 — — 27,652

Reverse split (1-30) rounding adjustment

— — — — ( 1 ) — — — — —

Stock based compensation (recoveries)

6 unchanged sentences

— — — — 1,167,974 3 120,285 ( 530 ) ( 99,923 ) 19,835

Stockholders’

Issuance of convertible redeemable preferred stock

— — 35,000 2,938 — — — — — 2,938

Redemption of convertible redeemable preferred stock

— — ( 35,000 ) ( 3,500 ) — — — — — ( 3,500 )

Deemed dividend on redeemable preferred stock

— — — 562 — — ( 562 ) — — —

Issuance of common stock, net of offering costs under open market sales agreement (ATM)

— — — — 1,493,878 — 5,427 — — 5,427

Reverse split (1-30) rounding adjustment

— — — — 97,218 ( 3 ) 3 — — —

Stock based compensation

— — — — — — 17 — — 17

Currency translation adjustment

— — — — — — — ( 163 ) — ( 163 )

Loss for the period

— — — — — — — — ( 11,590 ) ( 11,590 )

Balance, September 30, 2024

— $ — — $ — 2,759,070 $ — 125,170 $ ( 693 ) ( 111,513 ) $ 12,964

Treasury Stock

Comprehensive

Stockholders’

Balance, December 31, 2024

22 unchanged sentences

17,075,338 2 141,209 2,455,702 ( 2,565 ) ( 2,461 ) ( 124,018 ) 12,167

Stock-based compensation

24,881 — 132 — — — — 132

Issuance of common stock for service

49,505 — 50 — — — — 50

Repurchase of common stock

— — — 145,061 ( 141 ) — — ( 141 )

Issuance of common stock, net of costs

1,562,500 1 2,450 — — — — 2,451

Currency translation adjustment

— — — — — 158 — 158

Loss for the period

— — — — — — ( 2,806 ) ( 2,806 )

Balance, September 30, 2025

18,712,224 $ 3 143,841 $ 2,600,763 $ ( 2,706 ) $ ( 2,303 ) $ ( 126,824 ) $ 12,011

* All common share data has been retroactively adjusted to effect reverse stock splits in 2024 (See Note 1).

3 unchanged sentences

(in thousands)

Six Months Ended

Nine Months Ended

September 30,

CASH FLOWS FROM OPERATING ACTIVITIES:

$ ( 7,858 ) $ ( 17,062 )

Reconciliation of net loss to net cash used in operating activities:

2 unchanged sentences

Stock-based compensation

Impairment of intangible assets

Unrealized foreign exchange gains

( 13 ) ( 10 )

Non-cash interest expense

Change in fair value of warrant and derivative liabilities

( 1 ) ( 2,676 )

Changes in operating assets and liabilities:

2 unchanged sentences

Tax credit receivable

( 892 ) ( 837 )

Prepaid expenses

( 1,289 ) 630

Accounts payable

433 ( 3,623 )

Accrued expenses and other liabilities

( 2,646 ) ( 123 )

Income taxes payable

Net cash used in operating activities

( 11,577 ) ( 14,146 )

CASH FLOWS FROM FINANCING ACTIVITIES:

Proceeds from ATM sales of common stock, net of issuance costs

11,143 33,119

Net proceeds from sale of common stock and pre-funded warrant issuance

Proceeds from issuance of Convertible Redeemable Series A Preferred Stock

Redemption of Convertible Redeemable Series A Preferred Stock

Proceeds from convertible promissory notes and accrued interest, net of discount

2 unchanged sentences

Net cash provided by financing activities

10,888 32,557

Net increase in cash and cash equivalents

( 689 ) 18,411

Effect of exchange rate changes on cash and cash equivalents

( 1,949 ) ( 114 )

Cash and cash equivalents, beginning of period

Cash and cash equivalents, end of period

$ 16,895 $ 18,463

Supplemental information

6 unchanged sentences

Issuance of 2,359,650 common shares on conversion of 3,632,366 3i Exchange Warrants

Deemed dividend on Convertible Redeemable Series A Preferred Stock

See accompanying notes to condensed consolidated financial statements.

9 unchanged sentences

Pursuant to the requirements of Accounting Standard Codification (“ASC”) 205 - 40, Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern, the Company has evaluated whether there are conditions and events, considered in the aggregate, that raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the accompanying Financial Statements are issued.

The Company had an accumulated deficit of $ 124.0 million as of June 30, 2025.

Further, the Company incurred a net loss of $ 5.1 million and experienced negative cash flows from operations of $ 8.2 million for the six months ended June 30, 2025.

Based on the Company’s current operating plan, it estimates that its existing cash, cash equivalents and restricted cash of $ 17.8 million as of June 30, 2025 will be sufficient to enable the Company to fund its operating expenses and capital requirements through at least the next 12 months from the issuance of these Financial Statements.

The Company had an accumulated deficit of $ 126.8 million as of September 30, 2025.

Further, the Company incurred a net loss of $ 7.7 million and experienced negative cash flows from operations of $ 11.6 million for the nine months ended September 30, 2025.

Based on the Company’s current operating plan, it estimates that its existing cash, cash equivalents and restricted cash of $ 16.9 million as of September 30, 2025 will be sufficient to enable the Company to fund its operating expenses and capital requirements through at least the next 12 months from the issuance of these Financial Statements.

While the Company believes its capital resources are sufficient to fund the Company’s on-going operations for the next 12 months from the issuance date of the Financial Statements, the Company’s liquidity could be materially affected over this period by:

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Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the ASC and Accounting Standards Updates (“ASU”) of the Financial Accounting Standards Board (“FASB”).

The unaudited condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of our management, reflect all adjustments, which include only normal recurring adjustments, necessary to fairly state our financial position as of June 30, 2025, our results of operations and stockholders’ equity for the three and six months ended June 30, 2025 and 2024, and cash flows for the six months ended June 30, 2025 and 2024.

The financial data and the other financial information disclosed in these notes to the condensed consolidated financial statements related to the three and six month periods are also unaudited.

The results of operations for the three and six months ended June 30, 2025 are not necessarily indicative of the results to be expected for the year ending December 31, 2025 or for any other future annual or interim period.

The unaudited condensed consolidated financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of our management, reflect all adjustments, which include only normal recurring adjustments, necessary to fairly state our financial position as of September 30, 2025, our results of operations and stockholders’ equity for the three, six, and nine months ended September 30, 2025 and 2024, and cash flows for the nine months ended September 30, 2025 and 2024.

The financial data and the other financial information disclosed in these notes to the condensed consolidated financial statements related to the three and nine month periods are also unaudited.

The results of operations for the three and nine months ended September 30, 2025 are not necessarily indicative of the results to be expected for the year ending December 31, 2025 or for any other future annual or interim period.

The condensed consolidated balance sheet data as of December 31, 2024 was derived from our audited financial statements, but does not include all disclosures required by GAAP.

31 unchanged sentences

Adjustments that arise from exchange rate translations are included in other comprehensive loss in the consolidated statements of operations and comprehensive loss as incurred.

During the three months ended June 30, 2025 and 2024 , the Company recorded foreign exchange gains (losses) of $ 1.6 million and ($ 0.1 ) million, respectively.

During the six months ended June 30, 2025 and 2024, the Company recorded foreign exchange gains (losses) of $ 1.7 million and ($ 0.1 ) million, respectively.

During the three months ended September 30, 2025 and 2024 , the Company recorded foreign exchange gains (losses) of ($ 0.2 ) million and $ 0.2 million, respectively.

During the nine months ended September 30, 2025 and 2024, the Company recorded foreign exchange gains (losses) of ($ 2.1 ) million and $ 0.3 million, respectively.

Concentrations of credit risk and of significant suppliers

11 unchanged sentences

The Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents.

The Company had no cash equivalents on June 30, 2025 and December 31, 2024.

The Company had no cash equivalents on September 30, 2025 and December 31, 2024.

Property, plant and equipment

7 unchanged sentences

The Company records unrealized gains and losses related to foreign currency translation and instrument specific credit risk as components of other accumulated comprehensive loss in the condensed consolidated statements of operations and comprehensive loss.

During the three and six months ended June 30, 2025 and 2024 , the Company’s other comprehensive (loss) and gain was comprised of currency translation adjustments.

During the three and nine months ended September 30, 2025 and 2024 , the Company’s other comprehensive (loss) and gain was comprised of currency translation adjustments.

Recently Issued Accounting Pronouncements

10 unchanged sentences

The Company’s accrued expenses and other current liabilities are comprised of the following:

September 30,

($ in thousands)

5 unchanged sentences

Total accrued expenses and other current liabilities

$ 2,977 $ 5,232

Convertible promissory note due to Novartis

2 unchanged sentences

and all liabilities due to Novartis became immediately due and payable inclusive of interest which is continuing to accrue at 5 % per annum.

As of June 30, 2025 , the liability is recorded as a current liability on the Company’s condensed unaudited consolidated balance sheets as follows:

As of September 30, 2025 , the liability is recorded as a current liability on the Company’s condensed unaudited consolidated balance sheets as follows:

$ 3.6 million in accounts payable, $ 1.4 million convertible promissory notes and accrued interest, net of debt discount, and $ 0.4 million in accrued liabilities.

4 unchanged sentences

Warrant liabilities are categorized within Level 3 of the fair value hierarchy and are measured at fair value on a recurring basis.

The warrants issued in April 2023, July 2023, and September 2023 ( the “2023 Warrants”) are measured at fair value at each reporting period and the reconciliation of changes in fair value during the six months ended June 30, 2025 is presented in the following table:

The warrants issued in April 2023, July 2023, and September 2023 ( the “2023 Warrants”) are measured at fair value at each reporting period and the reconciliation of changes in fair value during the nine months ended September 30, 2025 is presented in the following table:

($ in thousands)

1 unchanged sentence

Change in fair value of warrant derivative liability

Balance at June 30, 2025

On June 30, 2025 , the Company used the Black-Scholes Merton model to estimate the fair value of the 2023 Warrants derivative liability at approximately $ 0 , using the following inputs:

Balance at September 30, 2025

On September 30, 2025 , the Company used the Black-Scholes Merton model to estimate the fair value of the 2023 Warrants derivative liability at approximately $ 0 , using the following inputs:

September 2023

Initial exercise price

$ 600.00 $ 600.00 $ 600.00

Stock price on valuation date

$ 1.01 $ 1.01 $ 1.01

Risk-free rate

3.68 % 3.68 % 3.71 %

Term (in years)

3.03 3.03 3.71

Rounded annual volatility

124 % 124 % 124 %

Stockholders ’ Equity

1 unchanged sentence

On March 3, 2025, the board of directors approved a share repurchase program, with authorization to purchase up to $ 5 million of the Company’s outstanding shares of common stock.

For the three months ended June 30, 2025, the Company repurchased 2,455,702 shares for an aggregate cost of $ 2,565,511 , inclusive of all transaction fees.

For the six months ended June 30, 2025 and 2024, the total proceeds used to repurchase shares were $ 2,565,511 and $ 0 , respectively.

As of June 30, 2025, there is $ 2,434,489 remaining for share repurchases under the share repurchase program.

For the three months ended September 30, 2025, the Company repurchased 145,061 shares at a cost of $ 140,038 .

For the nine months ended September 30, 2025, the Company purchased 2,600,763 shares for an aggregate cost of $ 2,705,550 , inclusive of $ 52,015 in transaction fees.

For the nine months ended September 30, 2025 and 2024, the total proceeds used to repurchase shares were $ 2,705,550 and $ 0 , respectively.

As of September 30, 2025, there is $ 2,294,450 remaining for share repurchases under the share repurchase program.

Share Issuance for Services

On April 4, 2025, the Company issued 53,368 restricted shares to a vendor in exchange for services rendered.

On July 7, 2025, the Company issued 49,505 restricted shares to a vendor in exchange for services rendered.

For the nine months ended September 30, 2025, the Company issued 102,873 restricted shares for services rendered.

Sale of Common Stock

On September 22, 2025, the Company entered into a Securities Purchase Agreement with a certain accredited investor, pursuant to which the Company agreed to sell the shares and/or prefunded warrants to the investor, in a private placement transaction.

The Company agreed to issue and sell 1,562,500 shares of the Company’s common stock for $ 1.60 per Share, and/or prefunded warrants to purchase one share of common stock per prefunded warrant, at an offering price of $ 1.60 per prefunded warrant, for gross proceeds to the Company of approximately $ 2.5 million, before deducting $ 0.05 million in legal fees and expenses.

On March 19, 2024, the Company entered into an At-The-Market Issuance Sales Agreement, as amended (the “Sales Agreement”) with Ascendiant Capital Markets, LLC (“Ascendiant”) pursuant to which, the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $ 0.0001 per share, having an aggregate gross sales price of up to $ 50 million, to or through the Ascendiant.

8 unchanged sentences

The Sales Agreement was fully utilized and terminated on March 31, 2025.

For the three months ended June 30, 2025 and 2024, the amount of proceeds generated from the sale of common stock under the Sales Agreement was $ 0.0 and $ 27.7 million from the sale of 0 and 1,062,821 shares, respectively.

For the six months ended June 30, 2025 and June 30, 2024, the Company sold an aggregate of 9,719,173 shares of its common stock pursuant to the Sales Agreement, resulting in net proceeds of $ 9.7 million, and $ 27.7 million from the sale of 1,062,821 shares, respectively.

For the three months ended September 30, 2025 and 2024, the amount of proceeds generated from the sale of common stock under the Sales Agreement was $ 0.0 and $ 5.4 million from the sale of 0 and 1,493,878 shares, respectively.

For the nine months ended September 30, 2025, the Company sold an aggregate of 9,719,173 shares of its common stock pursuant to the Sales Agreement, resulting in net proceeds of $ 9.7 million.

For the nine months ended September 30, 2024, the Company sold an aggregate of $ 33.1 million pursuant to the Sales Agreement from the sale of 2,556,927 shares.

Equity Incentive Plan

5 unchanged sentences

In January 2025, Board approved a 5 % increase to the authorized shares in the 2021 Incentive Plan from 353,163 to 717,941 .

Total shares available for the issuance of stock-based awards under the Company’s 2021 Incentive Plan was 0 shares at June 30, 2025.

Total shares available for the issuance of stock-based awards under the Company’s 2021 Incentive Plan was 85,051 shares at September 30, 2025.

Stock-based compensation expense has been reported in the Company’s condensed consolidated statements of operations as follows:

Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

($ in thousands)

6 unchanged sentences

Restricted Stock Units

The following table summarizes the restricted stock unit activity during the six months ended June 30, 2025:

The following table summarizes the restricted stock unit activity during the nine months ended September 30, 2025:

Average Grant

3 unchanged sentences

570,671 $ 1.01

Unvested balance at June 30, 2025

( 39,494 ) $ 2.11

At June 30, 2025, the Company had unrecognized stock-based compensation expense related to restricted stock awards of $ 0.65 million, which is expected to be recognized over the remaining weighted-average vesting period of 1.5 years.

( 85,051 ) $ 2.23

Unvested balance at September 30, 2025

620,164 $ 1.15

At September 30, 2025, the Company had unrecognized stock-based compensation expense related to restricted stock awards of $ 0.41 million, which is expected to be recognized over the remaining weighted-average vesting period of 1.3 years.

The expense is recognized over the vesting period of the award.

Stock Options

The following table summarizes stock option activity during the six months ended June 30, 2025:

The following table summarizes stock option activity during the nine months ended September 30, 2025:

Intrinsic Value

4 unchanged sentences

( 25,000 ) 1.01 9.3 —

Outstanding at June 30, 2025

Outstanding at September 30, 2025

50,000 $ 1.01 9.3 $ —

The aggregate intrinsic value of options is calculated as the difference between the exercise price of the underlying options and the fair value of the Company’s common stock for those options that had exercise prices lower than the fair value of the Company’s common stock.

As of June 30, 2025, the total compensation cost related to non-vested options awards not yet recognized is $ 21,531 with a weighted average remaining vesting period of 0.5 years.

As of September 30, 2025, the total compensation cost related to non-vested options awards not yet recognized is $ 11,915 with a weighted average remaining vesting period of 0.3 years.

The Company estimated the fair value of stock options granted in the period presented using a Black-Scholes option-pricing model utilizing the following assumptions:

As of June 30,

As of September 30,

Expected term (in years)

6 unchanged sentences

and all liabilities due to Novartis became immediately due and payable inclusive of interest which is continuing to accrue at 5 % per annum.

As of June 30, 2025 , the liability is recorded as a current liability on the Company’s condensed unaudited consolidated balance sheets as follows:

As of September 30, 2025 , the liability is recorded as a current liability on the Company’s condensed unaudited consolidated balance sheets as follows:

$ 3.6 million in accounts payable, $ 1.4 million convertible promissory notes and accrued interest, net of debt discount, and $ 0.4 million in accrued liabilities.

4 unchanged sentences

Potentially dilutive securities outstanding, as determined by the latest applicable conversion price, that have been excluded from diluted loss per share due to being anti-dilutive include the following:

Three and Six Months Ended June 30,

As of September 30,

Unvested restricted stock units

803,266 8,557

Commitments and Contingencies

6 unchanged sentences

The Company made a cash payment of $ 2.5 million to the SEC on April 2, 2025.

Subsequent Events

Appointment of Executive Officer

On July 1, 2025, Jeffrey S.

Ervin was appointed as Chief Financial Officer of the Company after the June 30, 2025 resignation of Alexander Epshinsky.

Epshinsky's departure was not the result of any disagreement with the Company regarding its operations, policies or practices, including accounting principles, practices or disclosures.

Allarity DRP Partnership

On July 15, 2025, the Company announced a new commercial agreement with a non-disclosed EU-based biotechnology company.

The agreement provides the partner with a non-exclusive global license to a range of selected proprietary Allarity DRP® algorithms in breast cancer, alongside laboratory services from Allarity’s Medical Laboratory in Denmark.

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

16 unchanged sentences

On March 3, 2025, the board of directors approved a share repurchase program, with authorization to purchase up to $5 million of the Company’s outstanding shares of common stock.

For the three months ended June 30, 2025, the Company repurchased 2,455,702 shares for an aggregate cost of $2,565,511, inclusive of all transaction fees.

For the six months ended June 30, 2025 and 2024, the total proceeds used to repurchase shares were $2,565,511 and $0, respectively.

As of June 30, 2025, there is $2,434,489 remaining for share repurchases under the share repurchase program.

SEC Investigation Settlement

On July 19, 2024, we received a “Wells Notice” from the Staff of the SEC relating to our previously disclosed SEC investigation.

The Wells Notice relates to our disclosures regarding meetings with the United States Food and Drug Administration (the “FDA”) regarding our NDA for Dovitinib or Dovitinib-DRP, which was submitted to the FDA in 2021.

We understand that all conduct relating to the SEC Wells Notice occurred during or prior to fiscal year 2022.

We also understand that three of our former officers received Wells Notices from the SEC relating to the same conduct.

A Wells Notice is neither a formal charge of wrongdoing nor a final determination that the recipient has violated any law.

The Wells Notice informed us that the SEC Staff has made a preliminary determination to recommend that the SEC file an enforcement action against us that would allege certain violations of the federal securities laws.

On March 13, 2025, we issued a press release that we reached a final settlement with the SEC relating to our previously disclosed SEC investigation.

As part of the settlement, we agreed to and paid a one-time civil penalty of $2.5 million on April 2, 2025.

For the three months ended September 30, 2025, the Company repurchased 145,061 shares for an aggregate cost of $140,038 inclusive of all transaction fees.

For the nine months ended September 30, 2025 and 2024, the total proceeds used to repurchase 2,600,763 and 0 shares were $2,705,550 inclusive of $52,015 in fees and $0, respectively.

As of September 30, 2025, there is $2,294,450 remaining for share repurchases under the share repurchase program.

Changes in Leadership

On June 10, 2025, the Board appointed Mr.

Jesper Høiland as a director of the Company, effective as of June 30, 2025.

This follows the resignation of Joseph W.

Vazzano on June 5, 2025, and effective June 30, 2025.

On July 1, 2025, Jeffrey S.

Ervin was appointed to the office of Chief Financial Officer of the Company, replacing Alexander Epshinsky upon his resignation on June 30, 2025.

Advancement in Intellectual Property

On June 30, 2025, the Company announced that IP Australia, the Australian Government agency that administers intellectual property rights in the country, formally accepted the Company’s patent application for its DRP® companion diagnostic specific to stenoparib.

The acceptance covers 40 claims and marks a key step in Allarity’s global strategy to protect the potential international commercialization of its proprietary DRP® platform alongside the clinical development of stenoparib.

FDA Fast Track Designation

On August 26, 2025, the Company announced the FDA granted Fast Track designation status for Stenoparib for the treatment of advanced ovarian cancer.

The FDA's Fast Track designation is intended to expedite the development and review of drugs that treat serious conditions and fill an unmet medical need.

This designation enables more frequent interactions with the FDA throughout the drug development process and potentially provides eligibility for accelerated approval, priority review, and rolling review if relevant criteria are met.

PIPE Investment

The Company agreed to issue and sell 1,562,500 shares of the Company’s common stock for $1.60 per Share, and/or prefunded warrants to purchase one share of common stock per prefunded warrant, at an offering price of $1.60 per prefunded warrant, for gross proceeds to the Company of approximately $2.5 million, before deducting $0.05 million in legal fees and expenses.

Risks and Uncertainties

9 unchanged sentences

We have incurred net losses in each year since inception.

Our net losses were $5.1 million and $5.5 million for the six months ended June 30, 2025 and 2024, respectively.

As of June 30, 2025, we had an accumulated deficit of $124.0 million and cash and cash equivalents of $17.8 million.

Our net losses were $7.7 million and $17.1 million for the nine months ended September 30, 2025 and 2024, respectively.

As of September 30, 2025, we had an accumulated deficit of $126.8 million and cash and cash equivalents of $16.9 million.

Substantially all our net losses have resulted from costs incurred in connection with our research and development programs and from general and administrative costs associated with our operations.

29 unchanged sentences

Results of Operations

Comparison of the Three and Six Months Ended June 30, 2025 and 2024 (unaudited)

Comparison of the Three and Nine Months Ended September 30, 2025 and 2024 (unaudited)

Three Months Ended

Six Months Ended

Nine Months Ended

September 30,

($ in thousands)

1 unchanged sentence

Research and development

Impairment of Intangible Assets

General and administrative

10 unchanged sentences

Research and Development Expenses

For the three months ended June 30, 2025, compared to June 30, 2024

The increase of $1.3 million in research and development expenses was primarily related to a $1.0 million cost in manufacturing and supplies needed for the expansion of the Phase II clinical trial of stenoparib.

For the three months ended September 30, 2025, compared to September 30, 2024

Research and development expenses increased $0.2 million primarily due to implementation costs and supplies of the Phase II clinical trial of stenoparib.

These expenses are recognized at the time of purchase.

Additional research study costs made up the remaining $0.2 million.

For the six months ended June 30, 2025, compared to June 30, 2024

Research and development expenses increased over $0.5 million with the expansion of the Phase II clinical trial to accelerate development of stenoparib in Advanced Ovarian Cancer.

The increase in research and development expenses was primarily related to an increase in regulatory costs $0.2 million, clinical site fees $0.1 million, and staff and consultant increases $0.2 million.

For the nine months ended September 30, 2025, compared to September 30, 2024

Research and development expenses increased over $0.7 million with the launch and expansion of the Phase II clinical trial to accelerate development of stenoparib in Advanced Ovarian Cancer.

The increase in research and development expenses was primarily related to an increase in study costs of $0.3 million.

A staffing increase of $0.8 million was partially offset by a $0.5 million reduction of contractor and consulting costs.

General and Administrative Expenses

For the three months ended June 30, 2025, compared to June 30, 2024

General and administrative expenses decreased by $0.5 million for the three months ended June 30, 2025, compared to June 30, 2024.

The decrease was primarily due to a decrease of $0.8 million in professional services which offset a $0.3 million increase in staffing costs including non-cash stock-based compensation.

For the six months ended June 30, 2025, compared to June 30, 2024

General and administrative expenses decreased by $0.9 million for the six months ended June 30, 2025, compared to June 30, 2024.

The decrease was primarily due to a $1.2 million decrease in professional services and $0.3 million increase in staffing costs including non-cash stock-based compensation.

For the three months ended September 30, 2025, compared to September 30, 2024

General and administrative expenses decreased by $0.3 million for the three months ended September 30, 2025, compared to September 30, 2024.

The decrease was primarily due to a decrease of $0.3 million in professional services.

For the nine months ended September 30, 2025, compared to September 30, 2024

General and administrative expenses decreased by $1.2 million for the nine months ended September 30, 2025, compared to September 30, 2024.

The decrease was primarily due to a $1.6 million decrease in professional services and an increase in $0.6 million of staffing and other administrative charges including non-cash equity compensation.

Other income (expense)

For the three months ended June 30, 2025, compared to June 30, 2024

There was little difference for the total other income in the comparable three months ended June 30, 2025.

However, interest income improved $0.2 million, interest expense decreased $0.4 million with the retirement of debt in 2024, and the foreign exchange gain amounted to $1.7 million difference.

All of this was offset by a 2024 change in fair value of the derivative and warrant liabilities of $2.2 million during the three months ended June 30, 2024.

For the six months ended June 30, 2025, compared to June 30, 2024

Other income was $2.1 million for the six months ended June 30, 2025, consisting primarily of $1.7 million in foreign exchange gains.

Other income for the six months ended June 30, 2024 was $2.1 million, when $2.7 million was recognized in a change in fair value adjustment of derivative and warrant liabilities.

The remaining difference for the comparable period was the $0.4 million increase of interest income and $0.5 million decrease in interest expense for the six months ended June 30, 2025.

For the three months ended September 30, 2025, compared to September 30, 2024

For the three months ended September 30, 2025, net other income decreased $0.6 million from the comparable quarter.

Interest income decreased $0.1 million and the foreign exchange impact was $0.5 million.

For the nine months ended September 30, 2025, compared to September 30, 2024

Other income was $1.8 million for the nine months ended September 30, 2025, consisting primarily of $1.3 million in foreign exchange gains.

Other income for the nine months ended September 30, 2024 was $2.5 million, when $2.7 million was recognized in a change in fair value adjustment of derivative and warrant liabilities.

The remaining difference for the comparable period was the $0.3 million increase of interest income and $0.4 million decrease in interest expense.

Liquidity, Capital Resources and Plan of Operations

Since our inception through June 30, 2025, our operations have been financed primarily by the sale of convertible promissory notes and the sale and issuance of our securities.

As of June 30, 2025, we had $17.8 million in cash and cash equivalents and an accumulated deficit of $124.0 million.

Since our inception through September 30, 2025, our operations have been financed primarily by the sale of convertible promissory notes and the sale and issuance of our securities.

As of September 30, 2025, we had $16.9 million in cash and cash equivalents and an accumulated deficit of $126.8 million.

Our primary use of cash is to fund operating expenses, which consist of research and development as well as regulatory expenses clinical programs for stenoparib, and to a lesser extent, general and administrative expenses.

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On March 21, 2024, we commenced an at the market offering of shares of our common stock.

During the six months ended June 30, 2025, we sold 9,719,173 shares of our common stock for net proceeds of $9.7 million.

During the nine months ended September 30, 2025, we sold 9,719,173 shares of our common stock for net proceeds of $9.7 million.

The at-the-market offering was terminated as of March 31, 2025.

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We have not included these payments in a table of contractual obligations since these contracts are generally cancellable at any time by us following a certain period after notice and therefore, we believe that our non-cancellable obligations under these agreements are not material.

Six Months Ended

Nine Months Ended

September 30,

($ in thousands)

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Effect of foreign exchange rates on cash

Net increase in cash and cash equivalents

Net increase (decrease) in cash and cash equivalents

Operating Activities

Net cash and cash equivalents used in operating activities was $8.2 million for the six months ended June 30, 2025, primarily due to a $2.5 million settlement payment to the Securities and Exchange Commission.

The remaining amount was used for working capital purposes and expansion costs to launch a Phase II Clinical Trial of stenoparib in advanced ovarian cancer.

Net cash and cash equivalents used in operating activities was $8.7 million for the six months ended June 30, 2024, primarily comprised of working capital.

Net cash and cash equivalents used in operating activities was $11.6 million for the nine months ended September 30, 2025, primarily derived from our $7.9 million net loss, a $2.5 million settlement payment to the Securities and Exchange Commission, and a $1.1 million decrease in operating assets and liabilities.

Net cash and cash equivalents used in operating activities was $14.1 million for the nine months ended September 30, 2024, primarily comprised of our $17.1 million net loss, $3.8 million increase in operating assets and liabilities, $2.7 million change in fair value of warrant liability and $0.4 million in deferred income taxes, partially offset by a $9.7 million impairment of intangible assets and $0.2 million in non-cash interest expense.

Financing Activities

Net cash and cash equivalents provided by financing activities was $8.6 million for the six months ended June 30, 2025.

The Company received an outstanding ATM receivable balance of $1.4 million in addition to the sale of 9,719,173 shares of our common stock for net proceeds of $9.7 million.

Net cash and cash equivalents provided by financing activities was $10.9 million for the nine months ended September 30, 2025.

The Company sold an aggregate of 9,719,173 shares of its common stock from the ATM resulting in net proceeds of $9.7 million, received an ATM receivable balance of $1.4 million, and sold shares and prefunded warrants representing 1,562,500 shares of our common stock for proceeds of $2.5 million.

However, the Company repurchased 2,600,763 common shares as part of a share repurchase program for $2.7 million.

Net cash and cash equivalents provided by financing activities was $27.7 million for the six months ended June 30, 2024, due to net proceeds from the sale of 1,062,821 shares of stock.

Net cash and cash equivalents provided by financing activities was $32.6 million for the nine months ended September 30, 2024, due to net proceeds from the sale of 2,556,927 shares of stock.

Operating Capital and Capital Expenditure Requirements

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Critical Accounting Policies and Use of Estimates

Our management’s discussion and analysis of financial condition and results of operations is based upon our unaudited condensed interim consolidated financial statements for the three and six months ended June 30, 2025 and 2024, and our audited consolidated financial statements for the years ended December 31, 2024 and 2023, which have been prepared in accordance with U.S.

Our management’s discussion and analysis of financial condition and results of operations is based upon our unaudited condensed interim consolidated financial statements for the three and nine months ended September 30, 2025 and 2024, and our audited consolidated financial statements for the years ended December 31, 2024 and 2023, which have been prepared in accordance with U.S.

The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses.

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Actual results may differ from these estimates under different assumptions and conditions.

Our significant accounting policies are described in the notes to our consolidated financial statements for the year ended December 31, 2024 included in the Form 10-K, and there have been no significant changes to our significant accounting policies during the six months ended June 30, 2025.

These unaudited condensed interim consolidated financial statements should be read in conjunction with our audited financial statements and accompanying notes.

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

What changed 10-Q

Item 1. Financial Statements