- Strengthened financial position through disciplined cost management, with a year-end 2025 cash position of
$14.7 million and runway into mid-2028 - Received FDA Fast Track designation for stenoparib, enabling accelerated development in advanced ovarian cancer
- Durable clinical benefit observed in ongoing stenoparib ovarian cancer study, including patients treated for nearly 30 months, with new Phase 2 protocol implemented
- Expansion of stenoparib development beyond ovarian cancer with the launch of a
VA -funded Phase 2 combination study in recurrent small cell lung cancer
today announced financial results for the year ended
“2025 was a year of continued execution and clinical progress for Allarity as we advanced stenoparib toward pivotal trials, FDA approval and commercialization in ovarian cancer. The FDA’s Fast Track designation for stenoparib underscores both the encouraging clinical benefit we have observed to date and the significant unmet medical need in this patient population. Over the course of the year, we initiated enrollment in a new Phase 2 clinical trial protocol designed to optimize dosing and refine future DRP-based patient selection in platinum-resistant ovarian cancer patients. This protocol reflects the compelling and durable clinical benefit we have observed throughout 2024 and 2025 and supports the acceleration of stenoparib’s development,” stated
“Furthermore, we broadened the potential reach of stenoparib through the launch of our first combination study evaluating stenoparib with temozolomide in recurrent small cell lung cancer in collaboration with the
2025 Corporate Highlights and Recent Developments
Clinical and Drug Development Progress
- Stenoparib received Fast Track designation from the
U.S. Food and Drug Administration for the treatment of advanced ovarian cancer, enabling more frequent regulatory engagement and the potential for accelerated review pathways. - Durable Clinical Benefit as monotherapy dosed twice daily observed: Updated analyses from the ongoing Phase 2 study in advanced ovarian cancer continued to demonstrate durable clinical benefit in heavily pre-treated patients. Certain patients have remained on therapy nearly 30 months, highlighting the long-term therapeutic potential of stenoparib in this population.
- New Trial Protocol Implemented and Enrolling: Following an in-depth review of maturing clinical data and consultation with leading gynecologic oncologists, the Company implemented a new Phase 2 clinical trial protocol during 2025 designed to accelerate stenoparib’s development toward pivotal studies, regulatory approval and eventual commercialization. The protocol focuses on patients with advanced, recurrent platinum-resistant or platinum-ineligible ovarian cancer—a population with limited therapeutic options—and aims to optimize stenoparib dosing while refining the DRP® companion diagnostic to better identify patients most likely to benefit from treatment.
- First Combination Trial Launched: During 2025, Allarity announced and initiated a Phase 2 trial evaluating stenoparib in combination with temozolomide for recurrent small cell lung cancer (SCLC), fully funded by the
U.S. Veterans Administration . This study represents the first clinical evaluation of the stenoparib–temozolomide combination and expands the development potential of stenoparib beyond ovarian cancer into additional tumor types with significant unmet medical need. Stenoparib has demonstrated a favorable tolerability profile in clinical studies to date, which may support its use in combination with DNA-damaging agents such as temozolomide while potentially avoiding the dose-limiting hematologic toxicities that have historically constrained the use of 1st generation PARP inhibitors in combination regimens. Preparations for the study were completed during 2025, and the trial subsequently opened for enrollment across 11VA medical centers inthe United States , with the first patients dosed in early 2026. - Presentations of Scientific and Clinical Data: The Company presented updated clinical and scientific data at multiple major oncology conferences during 2025, including the
AACR Special Conference on Ovarian Cancer and the AACR Annual Meeting, highlighting stenoparib’s clinical outcomes as well as the expanding capabilities of the DRP® platform.
Leadership Changes
During 2025, Allarity strengthened its leadership team and governance structure.
Jeff Ervin was appointed Chief Financial Officer ofAllarity Therapeutics inJuly 2025 .Mr. Ervin brings nearly two decades of executive leadership experience across healthcare and biotechnology, including previous roles as Chief Executive Officer of NASDAQ-listed IMAC Holdings and Co-Chief Financial Officer at NYSE-listedDDC Enterprises .Jesper Høiland was appointed to the Company’s Board of Directors in 2025.Mr. Høiland brings more than three decades of global pharmaceutical leadership experience, including senior executive roles atNovo Nordisk andAscendis Pharma .
Corporate Development and Financial Strengthening
- DRP® Platform Expansion: Allarity initiated commercial licensing of its DRP® companion diagnostic platform, marking an important step toward broader external utilization of the Company’s proprietary patient-selection technology.
- Allarity Medical Laboratory Growth: In connection with the licensing of its DRP® companion diagnostic platform, Allarity’s
Medical Laboratory inDenmark also became a supplier of commercial transcriptomic analysis services, supporting the generation of laboratory service revenue. - IP Portfolio Expansion: The Company strengthened its intellectual property portfolio through the acceptance of an Australian patent covering the stenoparib DRP companion diagnostic.
- Recent Financing: In
March 2026 , Allarity closed a$20 million non-convertible debt financing withStreeterville Capital designed to accelerate the advancement of stenoparib toward pivotal development, FDA approval and commercialization and extend the Company’s cash runway into mid-2028.
2025 Financial Results
Results of Operations for the Twelve Months Ended December 31, 2025, compared to the Twelve Months Ended December 31, 2024.
Cash Position: As of
Total Liabilities: As of
Revenue: The company generated
R&D Expenses: Research and Development (R&D) expenses were
G&A Expenses: General and Administrative (G&A) expenses were
Net Loss: The net loss attributable to shareholders was
About Stenoparib/2X-121
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant WNT/ß-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer, Small Cell
About the Drug Response Predictor – DRP® Companion Diagnostic
Allarity uses its drug-specific DRP® to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP® platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.
About
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Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide the Company’s current expectations or forecasts of future events. The words “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements regarding the continued clinical development of stenoparib (2X-121) in advanced ovarian cancer and small cell lung cancer; the completion of Phase 2 enrollment; anticipated timing of critical clinical data; preparation for and timing of End-of-Phase-2 FDA meeting; potential initiation of pivotal development; the development and potential prospective use of the Company’s DRP® companion diagnostic platform; and potential exploratory development of stenoparib in additional oncology indications, including other WNT-driven tumor types; the anticipated use of proceeds from the debt financing; and the filing of a Current Report on Form 8-K. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to clinical development and regulatory review, including the possibility that future clinical data, may not support safety, efficacy, or durability claims; risks that Phase 2 enrollment may not be completed as planned; delays in patient enrollment or trial completion; risks associated with preparation for or outcome of End-of-Phase-2 FDA meeting; uncertainties regarding potential initiation or timing of pivotal development; reliance on third-party investigators, clinical sites, and manufacturing partners; the predictive accuracy, regulatory acceptance, and clinical utility of the DRP® platform; risks related to exploratory development in additional tumor types; and the Company’s ability to secure sufficient funding or strategic partnerships to support its operations and development plans; risks relating to the Company’s ability to deploy the proceeds as anticipated, satisfy its obligations under the debt instruments, and complete and timely file the Form 8-K. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our Form 10-K annual report filed with the Securities and Exchange Commission (the “SEC”) on
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Company Contact:
investorrelations@allarity.com
Media Contact:
Thomas Pedersen
Carrotize PR & Communications
+45 6062 9390
tsp@carrotize.com
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except for share and per share data)
| 2025 | 2024 | ||
| ASSETS | |||
| Current assets: | |||
| Cash | |||
| Receivables from ATM sales | — | 1.416 | |
| Other current assets | 265 | 115 | |
| Prepaid expenses | 2.110 | 507 | |
| Tax credit receivable | 866 | 770 | |
| Total current assets | 17.928 | 22.341 | |
| Non-current assets: | |||
| Property, plant and equipment, net | 330 | 309 | |
| Total assets | |||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | |||
| Current liabilities: | |||
| Accounts payable | |||
| Accrued expenses and other current liabilities | 2.667 | 5.232 | |
| Warrant derivative liability | — | 1 | |
| Income taxes payable | 81 | 74 | |
| Convertible promissory note and accrued interest | 1.400 | 1.350 | |
| Total current liabilities | 8.430 | 10.839 | |
| Total liabilities | 8.430 | 10.839 | |
| Commitments and contingencies (Note 14) | |||
| Stockholders’ equity | |||
| Common stock, | 3 | 1 | |
| Additional paid-in capital | 144.233 | 131.130 | |
| Accumulated other comprehensive loss | (1.021) | (354) | |
| Accumulated deficit | (130.197) | (118.966) | |
| (3.190) | — | ||
| Total stockholders’ equity | 9.828 | 11.811 | |
| Total liabilities and stockholders’ equity |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
| 2025 | 2024 | |||
| Revenue: | ||||
| License Revenue | $ — | |||
| Total Revenue | 320 | — | ||
| Operating expenses: | ||||
| Research and development | 6.601 | 6.096 | ||
| Impairment of intangible assets | — | 9.703 | ||
| General and administrative | 6.324 | 11.442 | ||
| Total operating expenses | 12.925 | 27.241 | ||
| Loss from operations | (12.605) | (27.241) | ||
| Other income (expense) | ||||
| Interest income | 801 | 533 | ||
| Interest expenses | (185) | (653) | ||
| Foreign exchange gains (losses) | 757 | (212) | ||
| Change in fair value adjustment of warrant derivative liabilities | 1 | 2.677 | ||
| Total other income | 1.374 | 2.345 | ||
| Loss before income tax expense (benefit) | (11.231) | (24.896) | ||
| Income tax expense (benefit) | — | (381) | ||
| Net loss | (11.231) | (24.515) | ||
| Deemed dividends on Series A Preferred Stock | — | (299) | ||
| Deemed dividend on Series A Convertible Redeemable Preferred Stock | — | (562) | ||
| Gain on extinguishment of Series A Preferred Stock | — | 222 | ||
| Net loss attributable to common stockholders | ||||
| Net loss per common share, basic and diluted | ||||
| Weighted average common shares outstanding, basic and diluted | 14.378.942 | 1.606.989 | ||
| Other comprehensive loss | ||||
| Net loss | ||||
| Change in cumulative translation adjustment | (667) | 57 | ||
| Total comprehensive loss |
Attachment
