- Kaplan-Meier analyses show for the first time that median Overall Survival exceeds 25 months for Platinum Resistant and Refractory Ovarian Cancer Patients receiving stenoparib/2X-121 twice daily - Two patients continue on therapy now more than 24 months - Clinical Benefit Evident in patients with BRCAwt as well as BRCAmut genetics - Data presented at the American Association for Cancer Research (AACR) 7th Biennial Special Conference on Ovarian Cancer, Denver CO TARPON SPRINGS, Fla., September 22, 2025 – ...

Core Insights - Allarity Therapeutics, Inc. is a Phase 2 clinical-stage pharmaceutical company focused on developing stenoparib, a dual PARP and WNT pathway inhibitor, and its CEO has been invited to present at the Biomarkers & Precision Medicine 2025 conference in London [1][2] Company Overview - Allarity Therapeutics is dedicated to developing personalized cancer treatments, particularly stenoparib for advanced ovarian cancer patients, utilizing its Drug Response Predictor (DRP) technology [5] - The company has exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. [3] Drug Information - Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2, showing potential therapeutic action against various cancers, including ovarian cancer [3] - The DRP companion diagnostic platform is designed to select patients likely to benefit from specific drugs based on gene expression signatures, enhancing therapeutic benefit rates [4] Conference Participation - CEO Thomas Jensen will present a talk titled "A Gene Expression Based Biomarker For Predicting Response To Treatment With Stenoparib" at the conference on October 1, 2025, and will be available for individual meetings to discuss business development opportunities [6][8]

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 ...

PART I—FINANCIAL INFORMATION [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) Allarity Therapeutics' unaudited condensed consolidated financial statements detail financial position and performance as of June 30, 2025 [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheets as of June 30, 2025, show total assets of **$21.2 million** and total stockholders' equity of **$12.2 million** | Balance Sheet Highlights (in thousands) | June 30, 2025 (Unaudited) | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $17,801 | $19,533 | | Total current assets | $20,883 | $22,341 | | Total assets | $21,205 | $22,650 | | **Liabilities & Equity** | | | | Total current liabilities | $9,038 | $10,839 | | Total liabilities | $9,038 | $10,839 | | Total stockholders' equity | $12,167 | $11,811 | | Total liabilities and stockholders' equity | $21,205 | $22,650 | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The statements of operations show a net loss of **$2.3 million** for Q2 2025 and **$5.1 million** for H1 2025 | (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $2,321 | $1,058 | $3,724 | $3,228 | | General and administrative | $1,812 | $2,313 | $3,445 | $4,383 | | Loss from operations | $(4,133) | $(3,371) | $(7,169) | $(7,611) | | Net loss | $(2,320) | $(1,629) | $(5,052) | $(5,472) | | Net loss per common share | $(0.15) | $(3.34) | $(0.38) | $(21.78) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) The cash flow statements detail **$8.2 million** net cash used in operations and **$8.6 million** provided by financing for H1 2025 | (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(8,167) | $(8,703) | | Net cash provided by financing activities | $8,578 | $27,689 | | Effect of exchange rate changes on cash | $(2,143) | $81 | | Cash and cash equivalents, end of period | $17,801 | $19,233 | - Financing activities in the first six months of 2025 included **$11.1 million** in net proceeds from ATM stock sales, offset by a **$2.6 million** common stock repurchase[24](index=24&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes provide critical details on accounting policies, liquidity, reverse stock splits, and the SEC investigation settlement - The company believes its existing cash of **$17.8 million** as of June 30, 2025, is sufficient to fund operations for at least the next 12 months, despite having an accumulated deficit of **$124.0 million** and negative cash flows from operations of **$8.2 million** for the period[28](index=28&type=chunk) - The company effected two reverse stock splits in 2024: a **1-for-20** split on April 9 and a **1-for-30** split on September 11. All share and per-share data have been retroactively adjusted[30](index=30&type=chunk) - On March 3, 2025, the board approved a **$5 million** share repurchase program. During the three months ended June 30, 2025, the company repurchased **2,455,702 shares** for approximately **$2.6 million**[52](index=52&type=chunk) - The company reached a final settlement with the SEC regarding a previously disclosed investigation and made a one-time civil penalty payment of **$2.5 million** on April 2, 2025[67](index=67&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses financial performance, liquidity, and operational developments, including R&D and G&A expense changes and cash sufficiency [Results of Operations](index=19&type=section&id=Results%20of%20Operations) Operating expenses decreased slightly for H1 2025, with R&D increasing by **$0.5 million** and G&A decreasing by **$0.9 million** | ($ in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Increase/(Decrease) | | :--- | :--- | :--- | :--- | | Research and development | $3,724 | $3,228 | $496 | | General and administrative | $3,445 | $4,383 | $(938) | | Total operating expenses | $7,169 | $7,611 | $(442) | | Net loss | $(5,052) | $(5,472) | $420 | - The increase in R&D expenses for the six months ended June 30, 2025, was driven by costs related to the expansion of the Phase II clinical trial for stenoparib in Advanced Ovarian Cancer, including increases in regulatory costs, clinical site fees, and staffing[87](index=87&type=chunk) - The decrease in G&A expenses for the six months ended June 30, 2025, was primarily due to a **$1.2 million** reduction in professional services, partially offset by a **$0.3 million** increase in staffing costs[89](index=89&type=chunk) [Liquidity, Capital Resources and Plan of Operations](index=20&type=section&id=Liquidity%2C%20Capital%20Resources%20and%20Plan%20of%20Operations) The company had **$17.8 million** in cash as of June 30, 2025, and believes it has sufficient liquidity for the next 12 months - The company's cash balance was **$17.8 million** as of June 30, 2025, which management believes is sufficient to fund operations for at least the next 12 months[92](index=92&type=chunk)[94](index=94&type=chunk) - During the six months ended June 30, 2025, the company sold **9,719,173 shares** of common stock through its at-the-market (ATM) offering for net proceeds of **$9.7 million**. The ATM offering was terminated on March 31, 2025[94](index=94&type=chunk) [Cash Flows](index=21&type=section&id=Cash%20Flows) Net cash used in operating activities was **$8.2 million** for H1 2025, with **$8.6 million** provided by financing activities | ($ in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(8,167) | $(8,703) | | Net cash provided by financing activities | $8,578 | $27,689 | | Effect of foreign exchange rates on cash | $(2,143) | $81 | | Net increase (decrease) in cash | $(1,732) | $19,067 | [Quantitative and Qualitative Disclosures About Market Risk](index=22&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Allarity Therapeutics is exempt from providing quantitative and qualitative disclosures about market risk - As a smaller reporting company, Allarity Therapeutics is exempt from providing quantitative and qualitative disclosures about market risk[107](index=107&type=chunk) [Controls and Procedures](index=22&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were ineffective due to a material weakness in internal control over financial reporting - Management identified a material weakness in internal control over financial reporting as of June 30, 2025[108](index=108&type=chunk) - The material weakness is related to the accounting of the share repurchase plan that was initiated in the quarter ended June 30, 2025[109](index=109&type=chunk) - To remediate the weakness, management plans to update internal controls, implement new policies and procedures, and enhance review processes for contractual agreements[109](index=109&type=chunk)[114](index=114&type=chunk) PART II—OTHER INFORMATION [Legal Proceedings](index=24&type=section&id=Item%201.%20Legal%20Proceedings) Information on material legal proceedings, including the SEC investigation settlement, is incorporated by reference from Note 9 - Information regarding material legal proceedings is incorporated by reference from Note 9, which discusses the SEC investigation and settlement[116](index=116&type=chunk)[67](index=67&type=chunk) [Risk Factors](index=24&type=section&id=Item%201A.%20Risk%20Factors) The company updated its risk factors to include a material weakness in internal control over financial reporting, potentially impacting financial report reliability - A new risk factor was added to reflect the identification of material weaknesses in the company's internal control over financial reporting as of June 30, 2025[117](index=117&type=chunk) - The material weakness could limit the company's ability to prevent or detect a material misstatement in its financial statements, potentially leading to non-compliance with SEC filing requirements and a decline in stock price[118](index=118&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=25&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details the company's share repurchases, including the repurchase of **2,455,702 shares** during Q2 2025 | Period | Total Number of Shares Purchased | Average Price Paid per Share | | :--- | :--- | :--- | | April, 2025 | 1,857,024 | $1.07 | | May, 2025 | 99,242 | $1.12 | | June, 2025 | 499,436 | $0.94 | | **Total Q2 2025** | **2,455,702** | **N/A** | - The board of directors approved a share repurchase program on March 3, 2025, authorizing up to **$5 million** in purchases. As of the end of June 2025, **$2,434,489** remained available for future repurchases under the plan[122](index=122&type=chunk) [Other Information](index=25&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted or terminated Rule 10b5-1 trading arrangements during Q2 2025 - No directors or officers adopted or terminated a Rule 10b5-1 trading plan during the second quarter of 2025[125](index=125&type=chunk) [Exhibits](index=26&type=section&id=Item%206.%20Exhibits) This section provides an index of exhibits filed with the Quarterly Report on Form 10-Q, including required certifications

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].