On August 15, 2025 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor— reported financial results and provided an update on operational highlights for the second quarter ended June 30, 2025 (Press release, Allarity Therapeutics, AUG 15, 2025, View Source [SID1234655334]).
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"The second quarter of 2025 marked a period of strong operational execution for Allarity. Most notably, we continued to advance our lead program, stenoparib, with strong momentum in our new ovarian cancer trial protocol. In parallel, we expanded our proprietary DRP platform—both through a new commercial agreement granting a non-exclusive global license for our breast cancer DRP to a partner company, and scientifically with the development of a new DRP for the antibody therapy, daratumumab. On the financial front, we maintained a solid cash position and reduced liabilities, including a $2 million reduction in accounts payable and accrued expenses during the quarter. These developments position us well to deliver on our upcoming clinical milestones," said Thomas Jensen, CEO of Allarity Therapeutics.
"I would also like to take the opportunity to look further back, as I have now been the CEO for just over 1.5 years. I’m struck by how quickly our Company’s situation has improved. Just a year ago, we were still working to regain compliance with Nasdaq’s listing requirements. At the same time, we had just completed the cleanup of a previously complex capitalization table—which had deterred many prospective investors—and we had committed to a more focused strategy centered solely on the advancement of stenoparib. Thanks to the dedication of our team, the guidance of our board, and the support of our shareholders, we have resolved all compliance and regulatory matters, strengthened our leadership with seasoned management professionals bringing extensive life sciences experience to our board and executive team, and are successfully executing our stenoparib-focused strategy—having launched a refined monotherapy trial protocol, which is now steadily enrolling. In addition, we have advanced the Veterans Administration–funded combination trial of stenoparib and temozolomide in small cell lung cancer, which may provide valuable insights into stenoparib’s potential beyond ovarian cancer—a potential we believe could also extend to additional cancer types. Importantly, we have maintained disciplined spending. Therefore, as we present this business update—showing solid progress in the advancement of stenoparib, continued execution of our IP strategy, expansion of our DRP platform, growth in our laboratory activities, and new collaborations with R&D partners—I’m encouraged that Allarity is on the right path toward building greater interest in stenoparib, our unique DRP technology, and thereby the Company as a whole. I am deeply grateful for the trust and support from everyone who has made this progress possible."
Clinical and Drug Development Progress
Early trial enrollment momentum: First patients dosed in the new Phase 2 clinical trial protocol, reflecting strong investigator engagement. The trial focuses on recurrent, platinum-resistant or platinum-ineligible advanced ovarian cancer patients, with the goal of optimizing dose and refining patient selection to accelerate stenoparib’s path toward regulatory approval.
IBRI research collaboration: Initiated partnership with the Indiana Biosciences Research Institute to conduct advanced molecular and cellular studies clarifying the individual and combined contributions of PARP inhibition and WNT pathway modulation to stenoparib’s anti-cancer effects. This work aims to deepen mechanistic understanding, strengthen DRP-based patient selection, and potentially expand therapeutic opportunities, including in cancers such as colorectal cancer where WNT pathway activation is common.
Corporate and Strategic Developments
IP portfolio expansion: Received Australian patent acceptance notice for the Stenoparib DRP companion diagnostic. 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.
Allarity Medical Laboratory growth: Signed a new licensing and laboratory services agreement with an EU-based biotech, providing access to select DRP algorithms for breast cancer and securing laboratory services revenue commitments.
DRP platform expansion: Presented first antibody therapy–specific DRP for daratumumab in multiple myeloma at AACR (Free AACR Whitepaper) 2025, further showcasing the platform’s broad applicability across numerous cancer types and drug classes, and its ability to aid in the development of personalized, targeted therapies.
Partnering outreach: Participated in Pharma Partnering Summit US (May 14–15, 2025), where CEO Thomas Jensen presented a company overview highlighting stenoparib and the DRP companion diagnostic platform, and held one-on-one partnering meetings.
Board changes: Jesper Høiland appointed to the Board of Directors, succeeding Joseph Vazzano, effective June 30, 2025. Høiland brings more than 30 years of biopharmaceutical industry experience, including senior executive roles at Ascendis Pharma and Novo Nordisk, with a proven track record in global commercialization, corporate strategy, and business development.
Executive leadership changes: Jeffrey S. Ervin appointed as Chief Financial Officer effective July 1, 2025, succeeding Alexander Epshinsky. Mr. Ervin brings extensive financial and operational leadership experience in the biotechnology and healthcare sectors, having previously served as CEO of IMAC Holdings, where he led the company through its IPO and multiple strategic growth initiatives.
Anticipated Clinical Milestones in 2025
Ovarian cancer trial progress: Continued enrollment in new Phase 2 ovarian cancer trial protocol, with initial data expected in 2026.
SCLC combination trial launch: U.S. Veterans Administration–funded Phase 2 trial of stenoparib plus temozolomide in recurrent small cell lung cancer should open for enrollment in Q3, with patient recruitment expected to begin during H2 2025.
Second Quarter 2025 Operating Results
Cash Position: As of June 30, 2025, cash and cash equivalents totaled $17.8 million. The Company implemented a share repurchase plan and used $2.6 million for a stock buyback totaling 2,455,702 shares during the quarter. The Company also reduced accounts payable and accrued expenses by $2 million during the quarter.
R&D Expenses: Research and Development (R&D) expenses for the quarter ended June 30, 2025, were $2.3 million, compared to $1.06 million for the quarter ended June 30, 2024. The expense is consistent with planned clinical advancement activities, including the launch of the new Phase 2 ovarian cancer trial.
G&A Expenses: General and Administrative (G&A) expenses for the quarter ended June 30, 2025, were $1.8 million, compared to $2.3 million for the quarter ended June 30, 2024.
Net Loss: Net loss was $2.3 million for the quarter ended June 30, 2025, compared to $1.6 million for the quarter ended June 30, 2024. For the six months ended June 30, 2025, the Company’s net loss was $5.1 million, down from $5.5 million for the six months ended June 30, 2024.
About Stenoparib
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. 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.
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.