On May 15, 2026 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib (2X-121)—a differentiated, dual PARP and WNT pathway inhibitor, reported financial results and provided an update on operational highlights for the first quarter ended March 31, 2026.
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"Q1 2026 was an especially exciting period for Allarity. While we continue to accelerate stenoparib clinical development in advanced ovarian cancer, we have also begun to expand the reach for stenoparib into new cancer indications. Indeed, in Q1, we started enrolling relapsed small cell lung cancer patients onto the VA-funded trial combining stenoparib with temozolomide. This trial may help establish stenoparib as the combination agent of choice in the PARP inhibitor class. Moreover, we reported new preclinical data suggesting that stenoparib’s unique mechanism of action may make it an attractive therapy. And, we continued to strengthen the DRP companion diagnostic strategy to help identify the patients most likely to benefit from stenoparib. Critically important, we were also notified that one of our critical U.S. patent applications has been allowed, expanding the time horizon for stenoparib’s exclusivity," said Thomas Jensen, Chief Executive Officer of Allarity Therapeutics.
"Financially, we also excelled, ending the quarter with a significant cash position and a P&L profile consistent with the prior-year period. Net loss per share was lower compared with the prior-year period, and separately, we reduced our outstanding share count during the quarter through our repurchase program. We believe this combination of clinical and preclinical progress, a Notice of Allowance for new intellectual property and financial discipline solidifies the strongest position Allarity has ever had," Mr. Jensen continued.
Clinical and Drug Development Progress
Stenoparib Phase 3-ready drug production campaign is on track for third-quarter completion. Subsequent to quarter-end, Allarity announced that its active pharmaceutical ingredient manufacturing (API) campaign for stenoparib is progressing in line with the planned timeline for completion in the third quarter of 2026. No additional cash outlays for this API manufacturing campaign are anticipated.
Stenoparib DRP companion diagnostic received USPTO Notice of Allowance: Subsequent to quarter-end, the United States Patent and Trademark Office (USPTO) issued a Notice of Allowance for Allarity’s patent application covering the Company’s DRP companion diagnostic specific to stenoparib. The allowed application, if issued as a patent, is expected to extend exclusivity at least another 11 years for stenoparib when used in concert with the DRP as a companion diagnostic.
AACR 2026 data on DRP findings in ovarian cancer: Subsequent to quarter-end, Allarity presented clinical data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2026 (AACR 2026) demonstrating that the highest stenoparib DRP scores were associated with the greatest overall survival in patients treated with stenoparib, reinforcing the potential value of DRP-based patient selection.
AACR 2026 data indicated stenoparib’s potential in colorectal cancer: Allarity also presented new findings demonstrating stenoparib’s ability to modulate the WNT/β-catenin signaling pathway and inhibit the growth of human colorectal cancer cell lines at clinically relevant concentrations.
VA-funded Phase 2 lung cancer trial opened for enrollment and initiated patient dosing: During the first quarter, Allarity announced that enrollment had opened and the first patients had been dosed in its collaborative investigator-initiated Phase 2 trial with the U.S. Department of Veterans Affairs (VA) evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer. The trial, which represents the first clinical evaluation of stenoparib in combination with another anti-cancer agent, is fully funded through the VA’s Special Emphasis Panel on Precision Oncology and is open for enrollment across 11 VA medical centers throughout the United States.
Ovarian cancer program continued under FDA Fast Track designation: Allarity continued enrollment in its Phase 2 clinical trial protocol evaluating stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. The amended protocol is designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum-resistant patients and to accelerate the clinical development of stenoparib toward FDA approval.
Corporate and Strategic Developments
Closed $20 million promissory note financing to strengthen the Company’s financial position. During the first quarter, Allarity also secured a $6 million equity line of credit to support the continued advancement of stenoparib.
Reduced outstanding share count during the quarter while decreasing the net loss per share, reflecting the Company’s continued financial discipline and operational execution.
First Quarter 2026 Financial Highlights
Results of Operations for the Three Months Ended March 31, 2026
Cash Position: As of March 31, 2026, cash and restricted cash totaled $29.8 million, compared to total cash and restricted cash of $27.7 million at March 31, 2025.
Prepaid Expenses: Prepaid expenses increased to $3.5 million at March 31, 2026, compared to $2.1 million at December 31, 2025, primarily reflecting payments related to stenoparib API manufacturing activities supporting potential pivotal-stage development.
R&D Expenses: Research and Development (R&D) expenses were $1.3 million for the quarter ended March 31, 2026, compared to $1.4 million for the quarter ended March 31, 2025.
G&A Expenses: General and Administrative (G&A) expenses were $1.4 million for the quarter ended March 31, 2026, compared to $1.6 million for the quarter ended March 31, 2025.
Net Loss: Net loss attributable to common stockholders was $2.75 million for the quarter ended March 31, 2026, compared to $2.73 million for the quarter ended March 31, 2025. Net loss per common share was $0.17 for the quarter ended March 31, 2026, compared to $0.25 for the quarter ended March 31, 2025.
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/β-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 lung cancer and colorectal cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121. Allarity has two ongoing Phase 2 trial protocols for stenoparib in ovarian cancer patients. In the first, patients who had had 2+ lines of therapy were enrolled on stenoparib and given drug twice daily. This protocol has been closed to further enrollment but continues for the enrolled patients who are still receiving benefit from stenoparib administration. The updated data from this study were presented at the AACR (Free AACR Whitepaper) special conference on advances in ovarian cancer in September 2025. Note that, as these data are from an ongoing trial, analyses may change as the study fully matures. An amended protocol designed expressly to capitalize on the emerging clinical experience with stenoparib in platinum resistant patients began enrolling patients in the summer of 2025. This amended protocol enrolls only platinum resistant or platinum-ineligible patients and is designed to accelerate the clinical development of stenoparib toward FDA approval. In parallel, a separate Phase 2 trial evaluating stenoparib in combination with temozolomide for relapsed small cell lung cancer (SCLC) began enrolling patients in early 2026 and is currently enrolling patients across multiple VA sites.
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.
(Press release, Allarity Therapeutics, MAY 15, 2026, View Source [SID1234665788])