Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________ to_________ Commission file number 001-41160 ALLARITY THERAPEUTICS, INC. (Exact name of registrant as specified in its charter) | Del ...

Core Viewpoint - Allarity Therapeutics has successfully closed a $20 million non-convertible debt financing with Streeterville Capital, which is expected to extend its cash runway into the summer of 2028 [1]. Financing Details - The financing is structured as a note purchase agreement, involving two non-convertible promissory notes: one with an original principal amount of $10,930,000 and another secured promissory note of $10,000,000, together providing approximately $20 million in net proceeds to the Company [1]. Use of Proceeds - The Company plans to utilize the proceeds primarily to support key initiatives aimed at accelerating the development of stenoparib towards pivotal development, FDA approval, and commercialization [1].

Core Viewpoint - Allarity Therapeutics has successfully closed a $20 million non-convertible debt financing to support the development of stenoparib, a dual PARP and WNT pathway inhibitor, aimed at advancing its clinical trials and commercialization efforts [1][3][4] Financing Details - The financing consists of two non-convertible promissory notes: one for $10,930,000 and another secured note for $10,000,000, totaling approximately $20 million in net proceeds [2] - This financing is expected to extend the company's cash runway into the summer of 2028 [3][6] Use of Proceeds - The funds will primarily be used to support key initiatives for stenoparib, including completing Phase 2 enrollment, preparing for an FDA meeting, and advancing the companion diagnostic strategy [3][4] - The financing also supports broader strategic initiatives, including the development of the DRP companion diagnostic platform and exploratory development in additional WNT-driven tumor types [4] Clinical Development - Stenoparib has shown durable clinical benefits in heavily pre-treated ovarian cancer patients, with some patients remaining on therapy for over 30 months [4] - The ongoing open-label Phase 2 trial aims to generate critical clinical data to inform future regulatory engagement and pivotal trial development [4][5] About Stenoparib - Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2, with potential applications in various cancer types, including ovarian cancer, small cell lung cancer, and colorectal cancer [5] - Allarity holds exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. [5][9] About Allarity Therapeutics - Allarity Therapeutics is a clinical-stage biopharmaceutical company focused on developing personalized cancer treatments, particularly stenoparib, using its DRP® technology to identify patients likely to benefit from the drug [9]

Core Viewpoint - Allarity Therapeutics has initiated a Phase 2 clinical trial for stenoparib in combination with temozolomide for the treatment of relapsed small cell lung cancer (SCLC), with the first patients already dosed [1][4]. Group 1: Clinical Trial Details - The trial is funded by the U.S. Department of Veterans Affairs (VA) and is being conducted across 11 VA medical centers in the United States [2][8]. - Patient recruitment is ongoing, reflecting a significant unmet medical need in relapsed SCLC [4][5]. Group 2: Mechanism of Action - Stenoparib is a dual inhibitor targeting both PARP and the WNT pathway, which may enhance the effects of temozolomide while mitigating drug resistance associated with advanced cancers like relapsed SCLC [3][4]. - The drug's ability to cross the blood-brain barrier is particularly relevant for SCLC, where brain metastases are common [6]. Group 3: Safety and Efficacy - Stenoparib has shown a favorable safety profile compared to earlier-generation PARP inhibitors, which were limited by hematologic toxicity [4]. - The combination therapy aims to maximize tumor cell death while minimizing toxicity risks [4]. Group 4: Market Context - Over 218,000 Americans are diagnosed with lung cancer annually, with approximately 12% being SCLC, highlighting the need for effective treatment options [5]. - Real-world data indicates that only 40% of SCLC patients receive second-line treatment, with a median treatment duration of under two months [5]. Group 5: Company Overview - Allarity Therapeutics is focused on developing personalized cancer treatments, particularly stenoparib, and utilizes a drug response predictor (DRP) to identify patients likely to benefit from treatment [11]. - The company has exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. [7].

Core Viewpoint - Allarity Therapeutics has opened enrollment for a Phase 2 clinical trial evaluating the combination of stenoparib and temozolomide for recurrent small cell lung cancer (SCLC) [1][2]. Group 1: Trial Details - The trial is conducted in collaboration with the U.S. Department of Veterans Affairs (VA) and is fully funded through the VA's Special Emphasis Panel on Precision Oncology [2]. - It is registered as NCT06681220 and is open for enrollment at 11 VA sites across the U.S. [2][7]. - The study will assess the safety and efficacy of stenoparib in combination with temozolomide in patients with recurrent SCLC who have progressed after frontline treatment [3]. Group 2: Drug Mechanism and Benefits - Stenoparib is a dual PARP and WNT pathway inhibitor, which may enhance the activity of temozolomide while potentially offering a more favorable safety profile [3][4]. - The drug's ability to cross the blood-brain barrier may provide therapeutic potential for patients with brain metastases, a common complication in advanced SCLC [5]. - The study includes a blood-based biomarker developed in the VA Lung Precision Oncology Program to select patients most likely to benefit from the combination therapy [3]. Group 3: Company Insights - The CEO of Allarity Therapeutics emphasized the importance of this trial in exploring stenoparib's potential as a combination agent, particularly in settings where tolerability has been a limiting factor [4]. - The Principal Investigator noted that patients with relapsed SCLC have very few effective treatment options, and stenoparib's unique mechanism of action could provide significant benefits [4]. - Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. [8].

Core Insights - Allarity Therapeutics is focused on advancing stenoparib, a dual PARP and WNT pathway inhibitor, for the treatment of advanced ovarian cancer and other difficult-to-treat cancers [1][2][10] Group 1: Strategic Developments - In 2024, Allarity underwent a strategic reset, focusing exclusively on stenoparib and shedding legacy programs to enhance its therapeutic potential [2][3] - The company achieved FDA Fast Track Designation for stenoparib, indicating a significant step towards clinical and regulatory success [2] - Allarity simplified its capital structure and resolved legacy SEC matters, improving its corporate and financial foundations [3][4] Group 2: Clinical Progress - In 2025, Allarity accelerated stenoparib's path to FDA approval while expanding its clinical potential to recurrent Small Cell Lung Cancer [5][6] - Updated clinical data showed that median Overall Survival for patients on stenoparib had not been reached, with some patients remaining on therapy for over 30 months [6][10] - A new Phase 2 trial protocol was initiated to confirm and extend the clinical benefits of stenoparib [6][10] Group 3: Financial Health - The company maintained a disciplined operating model, aligning its cash runway with development objectives and managing expenses rigorously [9] - Selective share repurchases were made to enhance shareholder value while preserving financial stability [9] Group 4: Future Outlook - Looking ahead to 2026, Allarity aims to deepen and accelerate the advancement of stenoparib towards approval and explore additional cancer indications [11][12] - The foundation laid over the past two years is expected to support meaningful progress across clinical, regulatory, and strategic dimensions [12]

Financial Performance - For the nine months ended September 30, 2025, the company incurred net losses of $7.7 million compared to $17.1 million for the same period in 2024, reflecting a decrease of $9.4 million[83]. - The total operating expenses for the three months ended September 30, 2025, were $2.5 million, a decrease of $9.8 million from $12.3 million in the same period of 2024[88]. - General and administrative expenses decreased by $1.2 million for the nine months ended September 30, 2025, primarily due to a reduction in professional services[92]. - The company expects to continue incurring significant expenses and increasing operating losses over the next several years as it advances its clinical programs[83]. - The company reported a net cash outflow of $2.6 million in cash and cash equivalents for the nine months ended September 30, 2025, compared to an increase of $18.3 million in the same period of 2024[100]. - A settlement payment of $2.5 million to the Securities and Exchange Commission contributed to the cash outflow in operating activities for the nine months ended September 30, 2025[101]. Research and Development - Research and development expenses for the three months ended September 30, 2025, increased by $0.2 million primarily due to costs associated with the Phase II clinical trial of stenoparib[89]. - Research and development expenses for the nine months ended September 30, 2025, increased by over $0.7 million, mainly due to the launch and expansion of the Phase II clinical trial[90]. - The FDA granted Fast Track designation for stenoparib for the treatment of advanced ovarian cancer, which may expedite its development and review process[77]. - The company anticipates substantial expenses for the development and potential commercialization of its drug candidate, stenoparib, and may require additional funding in the future[98]. Cash and Financing Activities - The company had cash and cash equivalents of $16.9 million as of September 30, 2025, with an accumulated deficit of $126.8 million[95]. - Financing activities provided net cash of $10.9 million for the nine months ended September 30, 2025, including proceeds from the sale of common stock and prefunded warrants[103]. - The company believes its current cash balance is sufficient to fund operations for at least the next 12 months, but may need to seek additional capital[97]. - The company entered into a Securities Purchase Agreement to sell 1,562,500 shares at $1.60 per share, resulting in gross proceeds of approximately $2.5 million[79]. - The company sold 9,719,173 shares of common stock for net proceeds of $9.7 million during the nine months ended September 30, 2025[97]. - The company repurchased 2,600,763 common shares as part of a share repurchase program for $2.7 million during the nine months ended September 30, 2025[103]. - The company repurchased 145,061 shares for an aggregate cost of $140,038 during the three months ended September 30, 2025, with $2.3 million remaining under the share repurchase program[75]. Operational Insights - Operating activities resulted in a net cash outflow of $11.6 million for the nine months ended September 30, 2025, primarily due to a net loss of $7.9 million[101]. - The company has no off-balance sheet arrangements[106]. - There have been no significant changes to the company's accounting policies during the nine months ended September 30, 2025[108].

Core Insights - Allarity Therapeutics achieved FDA Fast Track designation for stenoparib in advanced ovarian cancer, highlighting the drug's potential in addressing significant unmet medical needs [2][3] - New clinical data indicates that the median overall survival for patients in the Phase 2 trial has exceeded 25 months, marking a significant milestone in treatment outcomes for this patient population [2][4] - The company is advancing its Drug Response Predictor (DRP) platform through new licensing agreements, enhancing its commercial capabilities [2][7] Clinical and Drug Development Progress - The FDA granted Fast Track designation to stenoparib for advanced ovarian cancer in August 2025, facilitating more frequent interactions with the FDA and potential eligibility for accelerated review pathways [3] - Landmark survival data presented in September 2025 shows that the median overall survival for patients receiving stenoparib has not yet been reached and now exceeds 25 months [4] - Enrollment is ongoing in a new Phase 2 trial for recurrent, platinum-resistant or platinum-ineligible advanced ovarian cancer, with critical data expected by the end of 2026 [5] Research Collaborations - Collaboration with the Indiana Biosciences Research Institute (IBRI) is progressing, focusing on understanding the contributions of PARP inhibition and WNT pathway modulation to stenoparib's anticancer activity [6] Corporate and Strategic Developments - A new commercial agreement was signed with an EU-based biotechnology company, providing a non-exclusive global license to selected breast cancer DRP algorithms [7] - CEO Thomas Jensen presented at a scientific forum, emphasizing the role of the stenoparib DRP companion diagnostic in optimizing patient selection for precision oncology [8] Financial Position - As of September 30, 2025, Allarity reported a cash position of $16.9 million, a decrease of $0.9 million from June 30, 2025, maintaining a financial runway through December 2026 [12] - Research and development expenses for Q3 2025 were $1.2 million, compared to $1.0 million in Q3 2024 [12] - General and administrative expenses decreased to $1.3 million in Q3 2025 from $1.6 million in Q3 2024, while the net loss attributable to common stockholders was $2.8 million, significantly reduced from $12.2 million in the same quarter of 2024 [13]

Core Insights - The median Overall Survival (mOS) for patients with platinum-resistant and refractory ovarian cancer receiving stenoparib exceeds 25 months, marking a significant improvement over existing therapies [1][3][4] - The clinical trial data presented at the AACR conference indicates that stenoparib shows clinical benefit in both BRCA wild-type and BRCA mutant patients, highlighting its unique mechanism of action as a dual inhibitor [2][3][5] - Stenoparib demonstrates a favorable safety profile with less myelotoxicity compared to earlier-generation PARP inhibitors, addressing the need for effective treatments in heavily pre-treated ovarian cancer patients [4][5] Clinical Trial Data - The ongoing Phase 2 trial includes patients with advanced ovarian cancer who are platinum-resistant or refractory, with a Stenoparib-specific Drug Response Predictor (DRP) score above 50 [2][3] - Two patients have been on therapy for over 24 months, including one with a wild-type BRCA gene, which typically does not respond well to PARP inhibitors [2][3] - The current Kaplan-Meier estimate for mOS has not yet been reached, with a median follow-up time of nearly 22 months, indicating promising long-term outcomes [3][4] Drug Mechanism and Development - Stenoparib is a dual-targeted inhibitor of PARP1/2 and tankyrase 1/2, with potential applications across various cancer types due to its action on the WNT signaling pathway [6][8] - Allarity Therapeutics has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. [6][8] - The company is actively enrolling patients in a new Phase 2 trial protocol specifically for platinum-resistant or platinum-ineligible patients to expedite the drug's development towards FDA approval [3][6] Drug Response Predictor (DRP) - The DRP is utilized to select patients likely to benefit from stenoparib based on their cancer's gene expression signature, enhancing the therapeutic benefit rate [7] - The DRP platform has shown significant predictive ability for clinical outcomes across various cancer studies, supporting personalized treatment approaches [7]

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]