Core Viewpoint - Allarity Therapeutics has reached a final settlement with the U.S. SEC regarding past disclosures related to its New Drug Application for Dovitinib, resolving all regulatory and legal challenges [1][2][3] Settlement Details - The settlement includes a one-time civil penalty of $2.5 million, with Allarity consenting to an administrative cease-and-desist order without admitting or denying the SEC's findings [2][4] - The SEC's investigation found violations of non-scienter-based provisions under Sections 17(a)(2) and (3) of the Securities Act of 1933, as well as Section 13(a) of the Securities Exchange Act of 1934 [2] Company Focus - With the resolution of legal matters, Allarity can now concentrate on advancing its clinical development plans for stenoparib, a dual PARP/Wnt pathway inhibitor [4] - The company has indicated that its cash position is expected to support operations into 2026, and the civil penalty will not affect its financial outlook or clinical programs [4] Product Information - Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2, showing potential for treating various cancers, including advanced ovarian cancer [5] - Allarity holds exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. [5] Company Overview - Allarity Therapeutics is a clinical-stage biopharmaceutical company focused on developing personalized cancer treatments, particularly through its DRP® technology for companion diagnostics [6]

Core Viewpoint - Allarity Therapeutics is advancing a Phase 2 trial for stenoparib in combination with temozolomide to treat recurrent Small Cell Lung Cancer (SCLC), fully funded by the U.S. Veterans Administration, aiming to address significant unmet medical needs in this patient population [1][7][10]. Company Overview - Allarity Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing personalized cancer treatments, particularly stenoparib, a dual PARP/tankyrase inhibitor [13]. - The company is headquartered in the U.S. and has a research facility in Denmark, committed to addressing significant unmet medical needs in cancer treatment [13]. Clinical Study Design - The Phase 2 trial will enroll approximately 65 extensive-stage SCLC patients across 11 VA medical centers, assessing progression-free survival and determining the recommended Phase 2 dose during an initial safety lead-in phase [5]. Mechanism of Action - Stenoparib is a dual PARP and tankyrase inhibitor that enhances the efficacy of temozolomide by blocking DNA repair mechanisms, potentially increasing cancer cell death and addressing treatment resistance associated with SCLC [2][6][8]. - The combination aims to overcome resistance mechanisms such as the MGMT enzyme and mismatch repair deficiencies that limit the effectiveness of temozolomide [8]. Funding and Financial Considerations - The trial is fully funded by the U.S. Veterans Administration, ensuring that it will not impact Allarity's financial outlook or other clinical programs [10]. - Allarity's cash position is reported to support operations into 2026, indicating a stable financial foundation for ongoing and future projects [10]. Regulatory Status - Investigators are in the process of obtaining final regulatory approvals from the U.S. Food and Drug Administration, the VA, and the Institutional Review Board before patient enrollment can begin [9].

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].

Patient enrollment set to begin at leading U.S. clinical trial sites, new drug product already deliveredTrial will advance stenoparib and the stenoparib-DRP Companion Diagnostic toward FDA approvalTwo patients in the ongoing phase 2 trial have now exceeded 17 months on stenoparib treatment Boston (February 24, 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/Wnt path ...

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 ...

Exhibit 99.1 Allarity Therapeutics Reports Third Quarter 2024 Financial Results and Provides Recent Operational Highlights - Cash balance at $18.5 million - Strengthened leadership team with new members driving stenoparib development - NASDAQ compliance regained Boston (November 14, 2024)—Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a clinical-stage pharmaceutical company dedicated to developing personalized cancer treatments using its proprietary, drug-specific patient selectio ...