TARPON SPRINGS, Fla., August 26, 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—today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to stenoparib, its investigational treatment for patients with advanced ovarian cancer. The FDA’s Fast Track designation is intended to expedite the developme ...

Core Insights - Allarity Therapeutics has successfully initiated enrollment in an advanced Phase 2 clinical trial for ovarian cancer, focusing on recurrent, platinum-resistant or platinum-ineligible patients [1][6] - The company has expanded its global intellectual property (IP) protection by securing an Australian patent for the stenoparib DRP companion diagnostic, which includes 40 claims [5] - A new service contract has been secured with a European biotech for Allarity Medical Laboratory, enhancing revenue opportunities [1][10] Clinical and Drug Development Progress - The Phase 2 clinical trial for stenoparib is progressing well, with initial patient dosing reflecting strong engagement from investigators [6] - A partnership has been initiated with the Indiana Biosciences Research Institute to conduct advanced studies on the anti-cancer effects of stenoparib, potentially expanding its therapeutic applications [6] - The company is also advancing a Veterans Administration-funded combination trial of stenoparib and temozolomide in small cell lung cancer, with patient recruitment expected to begin in the second half of 2025 [10] Financial Performance - As of June 30, 2025, Allarity reported cash and cash equivalents of $17.8 million, down from $19.5 million at the end of 2024 [16] - The company reduced its accounts payable and accrued expenses by $2 million during the quarter, indicating improved financial management [2][10] - Research and Development (R&D) expenses for the second quarter of 2025 were $2.3 million, compared to $1.06 million in the same quarter of 2024, reflecting ongoing clinical advancement activities [10][18] Corporate and Strategic Developments - Allarity has made significant progress in strengthening its leadership team, with new appointments to the Board of Directors and executive positions [10] - The company has launched a refined monotherapy trial protocol for stenoparib, which is now steadily enrolling patients [3][10] - Allarity's DRP platform has been expanded to include a new DRP for the antibody therapy daratumumab, showcasing its broad applicability across various cancer types [10]

LinkedIn: https://www.linkedin.com/company/allaritytx/ TARPON SPRINGS, Fla., May 12, 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—today announced the Company's CEO, Thomas Jensen, will deliver a company overview focused on stenoparib and the Company's DRP companion diagnostic platform and conduct one-on-one meetings at the Pharma Partne ...

Core Insights - Allarity Therapeutics has made significant advancements in the development of stenoparib, a dual PARP/WNT pathway inhibitor, particularly for advanced ovarian cancer treatment [1][2] - The company has undergone a strategic realignment to focus exclusively on stenoparib, discontinuing other clinical programs, which has accelerated progress in its clinical trials [2][3] - Financially, Allarity has strengthened its position, with a cash balance of approximately $25 million at the end of Q1 2025, providing a runway into 2027 for ongoing clinical activities [2][9] Clinical and Drug Development Progress - In 2024, Allarity executed a strategic realignment to focus solely on stenoparib, leading to accelerated progress in its clinical program [2] - The company reported a cash and cash receivable balance of $20.9 million as of December 31, 2024, which is expected to fund operations into 2027 [2][9] - Stenoparib has shown durable clinical benefits in heavily pre-treated ovarian cancer patients, with some patients remaining on treatment for over 17 months [3][4] Leadership Changes - Thomas Jensen has been appointed as the permanent CEO, transitioning from interim status, with a focus on advancing Allarity's strategic and clinical goals [8] - Key appointments include Jeremy Graff as President and Chief Development Officer, and Jose Iglesias as Consultant Chief Medical Officer, both bringing extensive oncology experience [8] Financial Strengthening and Corporate Development - The company reported a net loss of $24.5 million for 2024, an increase from $11.9 million in 2023, largely due to a non-cash impairment charge and costs related to an SEC investigation [10][21] - Allarity has implemented cost-reduction initiatives to strengthen financial sustainability while prioritizing stenoparib's advancement [8] - A $5 million share repurchase program has been authorized to reinforce long-term shareholder value [8] Regulatory and Compliance Resolutions - Allarity has resolved outstanding regulatory matters with the SEC related to past disclosures, allowing the company to focus on clinical and corporate progress [8] - The company regained compliance with Nasdaq listing requirements following a successful hearing [8]