On May 9, 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 recent operational highlights for the first quarter ended March 31, 2025 (Press release, Allarity Therapeutics, MAY 9, 2025, View Source [SID1234652829]).
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"The start of 2025 marks an important next chapter for Allarity," said Thomas Jensen, CEO of Allarity Therapeutics. "With enrollment about to begin in both our self-funded ovarian cancer trial and the Veterans Administration–funded combination trial in small cell lung cancer, we are focused on generating the data needed to advance stenoparib toward regulatory approval. The continued durability of response observed in ovarian cancer patients is encouraging, and we look forward to sharing updates on both trials in the months ahead."
Clinical and Drug Development Progress
Durable Clinical Benefit as monotherapy dosed twice daily: Multiple patients treated with stenoparib in the ongoing Phase 2 trial for advanced ovarian cancer exceeded 30 weeks on therapy, with two patients still on treatment and receiving benefit more than 19 months, underscoring the drug’s safety profile.
DRP Platform Expansion Beyond Small Molecules: At AACR (Free AACR Whitepaper) 2025, Allarity presented a novel DRP for daratumumab in multiple myeloma, marking the Company’s first DRP developed for a targeted antibody therapy. This milestone expands the versatility of the DRP platform, which was previously focused exclusively on small-molecule drugs.
New Protocol Implemented: Building on compelling data in the ongoing phase 2 ovarian cancer trial, the Company implemented a new Phase 2 protocol focused on platinum-resistant, advanced ovarian cancer patients, with the goal of optimizing dose and refining patient selection to accelerate stenoparib more aggressively toward regulatory approval.
Combination Trial Launched: Allarity announced a new Phase 2 trial evaluating stenoparib in combination with temozolomide for recurrent small cell lung cancer (SCLC), fully funded by the U.S. Veterans Administration. Allarity’s material contribution is limited to supplying the necessary stenoparib drug product. This novel trial is based upon compelling therapeutic rationale for the combination and could provide a new treatment option for these patients whose options are otherwise limited.
Clinical Data Presented at SGO: The Company presented updated Phase 2 clinical data at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting, demonstrating durable clinical benefit from stenoparib in heavily pre-treated ovarian cancer patients, including those with platinum-resistant, platinum-refractory, and BRCA wild-type disease.
Financial Strengthening and Corporate Development
Fully utilized the Company’s At-the-Market (ATM) offering program initiated in March 2024. With all capacity under the related Form S-3 now exhausted, the current ATM program has concluded.
Authorized a $5 million share repurchase program, reinforcing confidence in long-term shareholder value.
To date, the Company has repurchased approximately 2 million shares under the authorized buyback program.
Initiated efforts to combat potential illegal short selling, engaging ShareIntel to investigate trading irregularities through enhanced market surveillance and potential legal action.
Ended Q1 2025 with a cash and restricted cash balance of approximately $27 million, further reinforcing the Company’s financial stability and ability to execute on clinical development objectives.
Regulatory and Compliance Resolutions
Finalized settlement with the SEC following receipt of a Wells Notice in July 2024, resolving all outstanding regulatory matters related to past disclosures by prior management regarding FDA interactions on the Dovitinib NDA, which was submitted to the FDA in 2021.
Had class action lawsuit dismissed, closing all related shareholder litigation and further clearing the path for Allarity to focus on clinical and corporate progress.
Anticipated Clinical Milestones in 2025
New Ovarian Cancer Trial Protocol—New Protocol Enrollment: In the first half of 2025, Allarity expects to begin enrollment under a new protocol for stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer. The updated protocol design reflects the compelling, durable clinical benefit observed to date in platinum resistant patients. The protocol aims to provide the definitive foundation for pivotal registration trials for stenoparib in ovarian cancer.
New Small Cell Lung Cancer Trial—Combination Study: Patient enrollment will initiate in Q2-Q3 2025 in this new Phase 2 trial evaluating stenoparib in combination with temozolomide for recurrent small cell lung cancer (SCLC). The trial, fully funded by the U.S. Veterans Administration, will assess the potential of this novel combination to improve outcomes in recurrent SCLC patients with extremely limited therapeutic opportunities.
First Quarter 2025 Operating Results
Cash Position: As of March 31, 2025, cash, cash equivalents and restricted cash totaled $27.7 million compared to $20.9 million of cash and cash receivables at December 31, 2024.
R&D Expenses: Research and Development (R&D) expenses for the quarter ended March 31, 2025, were $1.4 million, compared to $2.2 million for the quarter ended March 31, 2024.
G&A Expenses: General and Administrative (G&A) expenses for the quarter ended March 31, 2025, were $1.6 million, compared to $2.1 million for the quarter ended March 31, 2024.
Net Loss: Net loss was $2.7 million for the quarter ended March 31, 2025, compared to $3.8 million for the quarter ended March 31, 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.