Core Viewpoint - Allarity Therapeutics has authorized a share repurchase program of up to $5 million, reflecting the company's confidence in its future and commitment to delivering value to shareholders and patients [1][2][3] Group 1: Share Repurchase Program - The share repurchase program allows Allarity to buy back up to $5 million of its common stock through February 28, 2026, without affecting its financial runway [1][2] - The program is discretionary, meaning the company can repurchase shares at its own pace and under market conditions, complying with legal requirements [3][4] Group 2: Company Confidence and Future Plans - The CEO of Allarity expressed confidence in the long-term vision and clinical potential of stenoparib, particularly for treating advanced ovarian cancer [3] - The company plans to initiate patient enrollment soon under a new trial protocol to further investigate stenoparib's dual mechanisms of action [3] Group 3: About Stenoparib - Stenoparib is a dual-targeted inhibitor of PARP1/2 and tankyrase 1/2, showing promise in treating various cancers, especially ovarian cancer [5] - The drug has exclusive global rights for development and commercialization, originally developed by Eisai Co. Ltd. [5] Group 4: Drug Response Predictor (DRP) - Allarity utilizes its proprietary Drug Response Predictor (DRP) to identify patients likely to benefit from stenoparib based on gene expression signatures [6] - The DRP platform has demonstrated the ability to predict clinical outcomes from drug treatment in numerous studies, enhancing the therapeutic benefit rate [6]

Core Viewpoint - Allarity Therapeutics has successfully dismissed a securities class action lawsuit, allowing the company to refocus on advancing its cancer treatment, stenoparib, and its companion diagnostic technology, the Drug Response Predictor (DRP) [1][2][3]. 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 proprietary DRP technology to identify patients who are most likely to benefit from stenoparib, enhancing the therapeutic benefit rate [5][6]. Legal Proceedings - The lawsuit, filed on September 13, 2024, alleged misleading statements regarding the regulatory prospects of the Dovitinib New Drug Application (NDA) [2]. - The case has been dismissed in its entirety, with no settlement or payment made by Allarity or its officers [2]. Product Information - Stenoparib is an orally available small-molecule inhibitor targeting PARP1/2 and tankyrase 1/2, showing potential in treating various cancers, including ovarian cancer [4]. - The DRP platform has demonstrated the ability to predict clinical outcomes from drug treatments in cancer patients, based on gene expression profiles from patient biopsies [5]. Future Focus - Following the dismissal of the lawsuit, the company aims to concentrate on advancing stenoparib and its companion diagnostic through a new Phase 2 trial protocol for advanced ovarian cancer [3][8].

Core Viewpoint - Allarity Therapeutics is advancing its Phase 2 clinical trial for stenoparib, a dual PARP/Wnt pathway inhibitor, in ovarian cancer, with expectations to provide critical data by summer 2026 for pivotal registration trials [1][2][3]. Group 1: Clinical Trial and Protocol - The new trial protocol was developed after a comprehensive review of ongoing Phase 2 clinical data in collaboration with ovarian cancer experts, showing durable clinical benefits in platinum-resistant advanced ovarian cancer patients [2][3]. - The protocol has received approval from the Institutional Review Board (IRB) of the first trial sites, allowing for immediate patient enrollment [2][3]. - The trial aims to deepen the understanding of stenoparib's clinical benefits and evaluate its impact on the Wnt pathway, which is significant in advanced ovarian cancer and other malignancies [3][4]. Group 2: Drug Development and Market Position - Stenoparib is positioned as a potentially safer and more effective alternative to traditional chemotherapy, with the trial designed to enhance clinical benefits through an additional dosing level [3][4]. - The ongoing Phase 2 study has shown promising results, with two patients remaining on treatment for over 17 months [5]. - The trial is expected to address the FDA's "Project Optimus" guidelines and set the stage for pivotal registration studies [3][4]. Group 3: Regulatory Pathways and Future Plans - Allarity plans to pursue multiple regulatory pathways to expedite approval in the first half of 2025 [4]. - Key data will be presented at various scientific and clinical conferences, with abstracts already accepted [4]. - The company has completed a new drug manufacturing campaign to ensure readiness for patient enrollment [2][4]. Group 4: About Stenoparib and DRP Technology - Stenoparib is an orally available small-molecule inhibitor targeting PARP1/2 and tankyrase 1/2, with potential applications across various cancer types [5][6]. - The Drug Response Predictor (DRP) technology is utilized to select patients likely to benefit from stenoparib, enhancing therapeutic benefit rates [7]. - The DRP platform has shown significant predictive capabilities in clinical outcomes across numerous studies [7]. Group 5: Company Overview - Allarity Therapeutics is focused on developing personalized cancer treatments, particularly stenoparib for advanced ovarian cancer, utilizing its proprietary DRP technology [8]. - 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 [8].

Core Viewpoint - Allarity Therapeutics is advancing the clinical development of stenoparib, a dual PARP/Wnt pathway inhibitor, towards FDA approval for advanced ovarian cancer, utilizing its Drug Response Predictor (DRP) technology for patient selection [1][2][4]. Group 1: Clinical Development Plans - The new Phase 2 protocol aims to optimize the dose of stenoparib and refine DRP patient selection criteria to maximize clinical benefits [1][2]. - The trial will focus on patients with advanced, recurrent, platinum-resistant ovarian cancer, a group that has shown durable clinical benefits from stenoparib [2][4]. - Patient enrollment is expected to begin in the first half of 2025, pending final protocol review by regulatory authorities [5][6]. Group 2: Mechanism of Action and Therapeutic Potential - Stenoparib is a small-molecule inhibitor targeting PARP1/2 and tankyrase 1/2, with potential implications for controlling the Wnt pathway, which is involved in various cancers [7]. - The trial is designed to enhance understanding of stenoparib's therapeutic mechanism, particularly its impact on the Wnt pathway [2][3]. Group 3: Drug Response Predictor (DRP) Technology - The DRP technology will be used to identify patients most likely to benefit from stenoparib, generating a robust data set to refine the DRP cut-off [3][9]. - The DRP platform has shown significant predictive ability for clinical outcomes in cancer patients across numerous studies [9]. Group 4: Company Background - Allarity Therapeutics is focused on developing personalized cancer treatments and has exclusive global rights for the development and commercialization of stenoparib [10]. - The company is headquartered in the U.S. and has a research facility in Denmark, addressing significant unmet medical needs in cancer treatment [10].

Core Viewpoint - Allarity Therapeutics has reached an agreement in principle with the SEC to resolve an investigation related to its disclosures concerning FDA meetings for its New Drug Application for Dovitinib, allowing the company to focus on advancing its cancer treatment, stenoparib [1][2][3]. Company Overview - Allarity Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing personalized cancer treatments, particularly stenoparib, a novel PARP/tankyrase inhibitor for advanced ovarian cancer patients [6]. - The company utilizes its proprietary drug-specific patient selection technology, DRP®, in its ongoing Phase 2 clinical trial for stenoparib [6]. SEC Investigation and Settlement - The SEC investigation pertains to the company's disclosures made during or prior to fiscal year 2022 regarding its NDA for Dovitinib, submitted in 2021 [2]. - The settlement is still subject to mutual agreement on final language and SEC approval, with no assurance that it will be finalized [2]. Clinical Development - The CEO of Allarity expressed optimism about stenoparib, noting that some patients in the Phase 2 trial have exceeded 14 months on treatment [3]. - The company aims to finalize the design of a follow-on trial to advance stenoparib toward FDA registration [3]. Financial Position - Allarity is financially positioned to continue its core operations and the development of stenoparib as planned into 2026 [3]. Product Information - Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2, with potential therapeutic benefits due to its unique action on the Wnt signaling pathway [5]. - The company holds exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. [5].

Two patients exceed 14 months on treatment in Phase 2 trial of advanced ovarian cancerAllarity maintains a cash balance of $18.5 million, sufficient to advance and accelerate stenoparib’s clinical development toward FDA approval Expansion of Allarity Medical Laboratory into revenue-generating services for external biotech clientsContinued focus on advancing stenoparib to address critical unmet needs in ovarian cancer Boston (November 18, 2024)—Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASD ...

Table of Contents Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.0001 par value per share ALLR The Nasdaq Stock Market LLC Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Smaller reporting company ☒ Emerging growth company ☒ UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30 ...

Financial Performance - Net loss attributable to common stockholders for Q3 2024 was $12.2 million, compared to a net loss of $5.6 million in Q3 2023, reflecting a 118% increase in losses[9] - The net loss attributable to common stockholders for the three months ended September 30, 2023, was $12,152 million, compared to a net loss of $5,552 million for the same period in 2022, representing an increase of 118.9%[16] - Basic and diluted net loss per common stock for the three months ended September 30, 2023, was $(7.71), compared to $(1,346.09) for the same period in 2022[16] - The company reported a net loss before tax benefit of $(11,967) million for the three months ended September 30, 2023, compared to $(4,447) million for the same period in 2022[16] - Total comprehensive loss attributable to common stockholders for the three months ended September 30, 2023, was $(11,753) million, compared to $(4,539) million for the same period in 2022[16] - The total operating loss for the nine months ended September 30, 2023, was $(19,924) million, compared to $(12,250) million for the same period in 2022, indicating a worsening operational performance[16] Cash and Assets - Cash balance as of September 30, 2024, was $18.5 million, a significant increase from $0.2 million at December 31, 2023[8] - The total assets as of September 30, 2024, were $20.4 million, up from $11.9 million at December 31, 2023[14] - Total liabilities decreased to $7.4 million as of September 30, 2024, from $14.6 million at December 31, 2023[14] Expenses - Research and development expenses for Q3 2024 were $1.0 million, down from $1.9 million in Q3 2023, indicating a 47% reduction[8] - General and administrative expenses decreased to $1.6 million in Q3 2024 from $2.5 million in Q3 2023, representing a 36% decline[9] - Research and development expenses for the three months ended September 30, 2023, were $1,021 million, compared to $1,948 million for the same period in 2022, reflecting a decrease of 47.5%[16] - Total operating expenses for the nine months ended September 30, 2023, were $19,924 million, an increase of 62.7% from $12,250 million in the same period of the previous year[16] - The company incurred impairment of intangible assets amounting to $9,703 million for the nine months ended September 30, 2023[16] Compliance and Leadership - The company regained NASDAQ compliance in October 2024, confirming adherence to minimum bid price requirements[7] - The company appointed Alexander Epshinsky as CFO in September 2024, bringing nearly a decade of financial leadership experience in the biotech sector[5] Clinical Trials and Patents - Two patients in the Phase 2 trial for stenoparib exceeded one year on treatment, showcasing durable clinical benefits[3] - A European patent for the DRP® companion diagnostic specific to stenoparib was granted in October 2024, enhancing market position[6] Other Financial Metrics - Interest income for the three months ended September 30, 2023, was $261 million, a significant increase from $12 million in the same period of the previous year[16] - The company reported a foreign exchange gain of $121 million for the three months ended September 30, 2023, compared to a loss of $(156) million in the same period of the previous year[16]

Core Viewpoint - Rosen Law Firm is reminding investors who purchased Allarity Therapeutics, Inc. securities between May 17, 2022, and July 19, 2024, of the upcoming lead plaintiff deadline on November 12, 2024 [1] Group 1: Class Action Details - Investors who purchased Allarity securities during the specified Class Period may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2] - A class action lawsuit has already been filed, and interested parties must move the Court to serve as lead plaintiff by November 12, 2024 [3] - Investors are encouraged to select qualified legal counsel with a successful track record in securities class actions [4] Group 2: Case Allegations - The lawsuit alleges that Allarity and its former officers made false and misleading statements regarding the regulatory prospects of Dovitinib, a drug candidate for renal cell carcinoma [5] - It is claimed that Allarity engaged in improper conduct related to the Dovitinib new drug application and premarket approval application, leading to increased regulatory scrutiny and potential legal repercussions [5] - The lawsuit asserts that Allarity downplayed the likelihood of enforcement actions following the announcement of an investigation into its conduct, resulting in materially false public statements [5]

NEW YORK, Nov. 07, 2024 (GLOBE NEWSWIRE) -- WHY: Rosen Law Firm, a global investor rights law firm, reminds purchasers of securities of Allarity Therapeutics, Inc. (NASDAQ: ALLR) between May 17, 2022 and July 19, 2024, both dates inclusive (the “Class Period”), of the important November 12, 2024 lead plaintiff deadline. SO WHAT: If you purchased Allarity securities during the Class Period you may be entitled to compensation without payment of any out of pocket fees or costs through a contingency fee arrang ...