Allarity Therapeutics, Inc.
For the period ended Sep 30, 2025. Filed Nov 14, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Sep 30, 2025 · Filed Nov 14, 2025
ALLR$0.96-1.1%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-15.
0001437749-25-027146
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-09-30; filed 2025-11-14.
0001437749-25-035003
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 65 previous paragraphs and 64 current paragraphs.
43 unchanged; 15 reworded; 6 added; 7 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (6)
Current report
FDA Fast Track Designation
Current report
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.
Current report
PIPE Investment
Current report
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.
Current report
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.
Current report
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.
Removed paragraphs (7)
Previous report
SEC Investigation Settlement
Previous report
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.
Previous report
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.
Previous report
Advancement in Intellectual Property
Previous report
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.
Previous report
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.
Previous report
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.
Reworded paragraphs (15)
Previous wording
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.
Current wording
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 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.
Previous wording
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. 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. We expect to continue to incur significant expenses and increasing operating losses over at least the next several years. We expect our expenses will increase substantially in connection with our ongoing activities, as we:
Current wording
We have incurred net losses in each year since inception. 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. We expect to continue to incur significant expenses and increasing operating losses over at least the next several years. We expect our expenses will increase substantially in connection with our ongoing activities, as we:
Previous wording
Comparison of the Three and Six Months Ended June 30, 2025 and 2024 (unaudited)
Current wording
Comparison of the Three and Nine Months Ended September 30, 2025 and 2024 (unaudited)
Previous wording
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. These expenses are recognized at the time of purchase. Additional research study costs made up the remaining $0.2 million.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
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. The at-the-market offering was terminated as of March 31, 2025. We believe that our current cash balance is sufficient to fund operations through at least the next 12 months from the date of this Quarterly Report. We may need to seek additional capital through the sale of our securities or other sources to carry out all of our planned research and development and potential commercialization activities. There are no assurances, however, that we will be successful in raising additional working capital, or if we are able to raise additional working capital, we may be unable to do so on commercially favorable terms. Our failure to raise capital or enter into other such arrangements if and when needed would have a negative impact on our business, results of operations and financial condition and our ability to develop stenoparib.
Current wording
On March 21, 2024, we commenced an at the market offering of shares of our common stock. 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. We believe that our current cash balance is sufficient to fund operations through at least the next 12 months from the date of this Quarterly Report. We may need to seek additional capital through the sale of our securities or other sources to carry out all of our planned research and development and potential commercialization activities. There are no assurances, however, that we will be successful in raising additional working capital, or if we are able to raise additional working capital, we may be unable to do so on commercially favorable terms. Our failure to raise capital or enter into other such arrangements if and when needed would have a negative impact on our business, results of operations and financial condition and our ability to develop stenoparib.
Previous wording
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.
Current wording
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.
Previous wording
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. However, the Company repurchased 2,455,702 common shares as part of a share repurchase program for $2.6 million.
Current wording
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.
Previous wording
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.
Current wording
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.
Previous wording
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. GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses. On an on-going basis, we evaluate our critical accounting policies and estimates. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable in the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions and conditions.
Current wording
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. GAAP. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, and expenses. On an on-going basis, we evaluate our critical accounting policies and estimates. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable in the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions and conditions.
Previous wording
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.
Current wording
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 nine months ended September 30, 2025. These unaudited condensed interim consolidated financial statements should be read in conjunction with our audited financial statements and accompanying notes.