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]

Core Insights - Allarity Therapeutics has signed a new commercial agreement with a non-disclosed EU-based biotechnology company, granting a non-exclusive global license to selected proprietary Drug Response Predictor (DRP) algorithms in breast cancer, along with laboratory services from Allarity's Medical Laboratory in Denmark [1][2] Group 1: Agreement Details - The agreement includes advanced transcriptome analysis services to support the partner's precision oncology solutions in breast cancer and secures purchase commitments for Allarity's laboratory services over the next year [2] - The financial impact of this agreement on Allarity's outlook is not expected to be significant [2] Group 2: Technology and Expertise - The agreement validates the broad applicability of Allarity's DRP technology, which is based on decades of research and development, aimed at improving patient selection and treatment outcomes [3] - Allarity's DRP platform utilizes advanced gene expression profiling to predict individual tumor responses to specific therapies, covering over 100 drugs, including investigational compounds and approved drugs [3][5] Group 3: Product Information - Stenoparib, developed by Allarity, is a dual-targeted inhibitor of PARP1/2 and tankyrase 1/2, showing potential as a therapeutic for various cancers, including ovarian cancer [4] - The company holds exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. [4][6] Group 4: Company Overview - Allarity Therapeutics is a clinical-stage biopharmaceutical company focused on developing personalized cancer treatments, particularly through the use of its DRP technology for selecting patients who may benefit most from stenoparib [6]

TARPON SPRINGS, Fla., July 7, 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—as a personalized cancer treatment using its proprietary, drug-specific Drug Response Predictor (DRP) patient selection technology, today announced the appointment of Jeff Ervin as the Company's new Chief Financial Officer (CFO). He succeeds Alexander Epshinsky, ...

Core Viewpoint - Allarity Therapeutics has received formal acceptance of its patent application for the Drug Response Predictor (DRP) companion diagnostic specific to stenoparib from IP Australia, marking a significant step in its global strategy for intellectual property protection and commercialization of its proprietary technology [1][2][3]. Company Overview - Allarity Therapeutics, Inc. is a Phase 2 clinical-stage pharmaceutical company focused on developing stenoparib, a dual PARP and WNT pathway inhibitor, as a personalized cancer treatment using its proprietary DRP technology [1][6]. - The company is headquartered in the U.S. and has a research facility in Denmark, aiming to address significant unmet medical needs in cancer treatment [6]. Patent and Intellectual Property - The accepted patent covers 40 claims and is a crucial part of Allarity's strategy to protect its DRP platform internationally, with the patent expected to be granted within 20 working days if unopposed [2][3]. - Allarity has previously secured a European patent for the stenoparib DRP and holds 18 granted patents for drug-specific DRPs, including eight in the U.S. [3]. Drug and Technology Details - Stenoparib is an orally available small-molecule inhibitor targeting PARP1/2 and tankyrase 1/2, with potential applications in various cancer types, particularly ovarian cancer [4]. - The DRP technology is designed to select patients likely to benefit from specific drugs based on gene expression signatures, enhancing therapeutic benefit rates [5]. Future Prospects - The acceptance of the Australian patent is seen as a vital achievement in securing international IP protection while advancing stenoparib through Phase 2 trials towards U.S. regulatory approval [3].

Core Insights - Allarity Therapeutics has initiated a Phase 2 clinical trial for stenoparib, with the second patient dosed shortly after the trial's launch, indicating strong engagement from investigators [1][2] - Stenoparib is being evaluated for its potential benefits in patients with advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer, a group with limited treatment options [2][4] - The trial aims to further assess the unique WNT-modulating mechanism of action of stenoparib and advance Allarity's proprietary Drug Response Predictor (DRP) companion diagnostic [3][4] Company Overview - Allarity Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing personalized cancer treatments, particularly stenoparib, a dual-targeted inhibitor for advanced ovarian cancer [6] - The company utilizes its DRP technology to identify patients who are likely to benefit from stenoparib based on their cancer's gene expression signature [5][6] - Allarity has exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. [4]

Core Viewpoint - Allarity Therapeutics has appointed Jesper Høiland to its Board of Directors, replacing Joseph Vazzano, as the company prepares for the next phases of clinical development and potential commercialization of its cancer treatment, stenoparib [1][4]. Group 1: Leadership Changes - Jesper Høiland has been a strategic consultant for Allarity since October 2024 and brings over 30 years of experience in global pharmaceutical commercialization [2][3]. - Joseph Vazzano will resign from the Board effective June 30, 2025, after contributing to Allarity's development for two years [1][4]. Group 2: Company Overview - Allarity Therapeutics is a Phase 2 clinical-stage pharmaceutical company focused on developing stenoparib, a dual PARP and WNT pathway inhibitor, as a personalized cancer treatment [1][7]. - The company utilizes its proprietary Drug Response Predictor (DRP) technology to select patients who may benefit most from stenoparib [6][8]. Group 3: Product Information - Stenoparib is an orally available small-molecule inhibitor targeting PARP1/2 and tankyrase 1/2, with potential applications in various cancers, including ovarian cancer [5]. - Allarity holds exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. [5]. Group 4: Strategic Importance - The appointment of Jesper Høiland is seen as a strategic move to enhance Allarity's governance and operational focus during a critical time in the company's development [4]. - Høiland's experience in preparing for the commercialization phase of investigational drugs is expected to be valuable as Allarity advances its clinical development [4].

Core Viewpoint - Allarity Therapeutics has announced a research collaboration with the Indiana Biosciences Research Institute (IBRI) to enhance the understanding of the dual mechanism of action of its drug stenoparib, a novel cancer treatment [1][3]. Company Overview - Allarity Therapeutics, Inc. is a Phase 2 clinical-stage pharmaceutical company focused on developing stenoparib, a dual PARP and WNT pathway inhibitor, as a personalized cancer treatment [1][9]. - The company utilizes its proprietary Drug Response Predictor (DRP) technology to select patients who may benefit most from stenoparib [1][7]. Drug Mechanism and Collaboration - Stenoparib is an orally available small-molecule inhibitor that targets PARP1/2 and tankyrase1/2, impairing DNA repair and inhibiting the WNT signaling pathway, which is associated with chemoresistance in various cancers [2][6]. - The collaboration with IBRI will involve advanced studies to clarify how PARP inhibition and WNT pathway modulation contribute to stenoparib's anticancer effects [2][3]. Strategic Importance - Understanding stenoparib's dual biological effects is crucial for Allarity's long-term clinical development strategy, enhancing engagement with oncologists and biotech investors [3]. - The collaboration may also support future marketing approval efforts for stenoparib and clarify its mechanism of action in ongoing clinical trials for advanced ovarian cancer and recurrent small cell lung cancer [3][4]. Research Institute Profile - The Indiana Biosciences Research Institute (IBRI) is a leading translational research institute that focuses on solving high-impact biomedical challenges, including cancer [5].

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 continues to show clinical benefits of stenoparib in heavily pre-treated ovarian cancer, with two patients on treatment for over 19 months [1][5] - The company has initiated a share repurchase program and ended Q1 2025 with approximately $27 million in cash and restricted cash, indicating financial stability [1][10] Clinical and Drug Development Progress - Enrollment is set to begin in self-funded ovarian cancer trials and a Veterans Administration-funded trial for small cell lung cancer [2] - A new Phase 2 protocol for platinum-resistant advanced ovarian cancer patients has been implemented to optimize dosing and patient selection [5][10] - A new Phase 2 trial evaluating stenoparib in combination with temozolomide for recurrent small cell lung cancer has been launched, fully funded by the U.S. Veterans Administration [5][10] - Updated Phase 2 clinical data presented at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting shows durable clinical benefits in heavily pre-treated ovarian cancer patients [5] Financial Strengthening and Corporate Development - The company fully utilized its At-the-Market (ATM) offering program initiated in March 2024, concluding the current ATM program [5] - A $5 million share repurchase program has been authorized, with approximately 2 million shares repurchased to date [5] - Cash, cash equivalents, and restricted cash totaled approximately $27.7 million as of March 31, 2025, compared to $20.9 million at the end of 2024 [10] - Research and Development (R&D) expenses for Q1 2025 were $1.4 million, down from $2.2 million in Q1 2024 [10] - General and Administrative (G&A) expenses for Q1 2025 were $1.6 million, down from $2.1 million in Q1 2024 [10] - The net loss for Q1 2025 was $2.7 million, compared to $3.8 million for the same period in 2024 [10]