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]

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].

Core Viewpoint - Allarity Therapeutics has initiated a new Phase 2 clinical trial for stenoparib, targeting advanced, platinum-resistant or platinum-ineligible ovarian cancer, with the first patient enrolled [1][2]. Group 1: Clinical Development - The new trial protocol aims to accelerate the clinical development of stenoparib and its companion diagnostic, Drug Response Predictor (DRP), towards potential FDA approval [2][5]. - The updated study design includes an additional dosing level to explore optimal dosing for enhanced clinical benefit, aligning with FDA's Project Optimus initiative [4]. Group 2: Clinical Efficacy and Safety - Previous Phase 2 studies indicated that patients receiving twice-daily stenoparib experienced durable clinical benefits, with some patients remaining on treatment for over 20 months [2][3]. - The new trial will further assess the efficacy and safety of stenoparib while deepening the understanding of its modulation of the WNT signaling pathway, which is crucial in cancer progression [3][6]. Group 3: Drug Response Predictor (DRP) - The DRP is designed to select patients likely to benefit from stenoparib based on their cancer's gene expression signature, potentially enhancing therapeutic benefit rates [7][8]. - The DRP platform has shown significant predictive ability for clinical outcomes across various cancer studies [8]. Group 4: Company Overview - Allarity Therapeutics is focused on developing personalized cancer treatments, particularly stenoparib, a novel PARP/tankyrase inhibitor for advanced ovarian cancer patients [9]. - The company is headquartered in the U.S. and has a research facility in Denmark, committed to addressing unmet medical needs in cancer treatment [9].

[PART I—FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for the quarter ended March 31, 2025, detailing balance sheets, statements of operations, and cash flows, reporting a **$2.7 million** net loss and **$27.7 million** in cash, cash equivalents, and restricted cash, with all share data adjusted for prior reverse stock splits Condensed Consolidated Balance Sheet Highlights (Unaudited) | Account | March 31, 2025 ($ in thousands) | December 31, 2024 ($ in thousands) | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | 25,201 | 19,533 | | Restricted cash | 2,503 | — | | Total current assets | 29,422 | 22,341 | | Total assets | 29,730 | 22,650 | | **Liabilities & Equity** | | | | Total current liabilities | 11,061 | 10,839 | | Total liabilities | 11,061 | 10,839 | | Total stockholders' equity | 18,669 | 11,811 | | Total liabilities and stockholders' equity | 29,730 | 22,650 | Condensed Consolidated Statements of Operations (Unaudited) | Account | Three Months Ended March 31, 2025 ($ in thousands) | Three Months Ended March 31, 2024 ($ in thousands) | | :--- | :--- | :--- | | Research and development | 1,403 | 2,170 | | General and administrative | 1,633 | 2,070 | | **Loss from operations** | **(3,036)** | **(4,240)** | | **Net loss** | **(2,732)** | **(3,843)** | | Net loss per common share, basic and diluted | (0.25) | (664.16) | Condensed Consolidated Statements of Cash Flows (Unaudited) | Activity | Three Months Ended March 31, 2025 ($ in thousands) | Three Months Ended March 31, 2024 ($ in thousands) | | :--- | :--- | :--- | | Net cash used in operating activities | (2,686) | (1,399) | | Net cash provided by financing activities | 11,143 | 1,380 | | Effect of exchange rate changes on cash | (286) | 165 | | **Net increase in cash, cash equivalents and restricted cash** | **8,457** | **(19)** | - The company effected a **1-for-20 reverse stock split** on April 9, 2024, and a **1-for-30 reverse stock split** on September 11, 2024, with all historical share and per-share amounts **retroactively adjusted** to reflect these splits[7](index=7&type=chunk)[26](index=26&type=chunk) - As of March 31, 2025, the company had an accumulated deficit of **$121.7 million**, and management believes its existing cash of **$27.7 million** is **sufficient to fund operations for at least the next 12 months** from the financial statement issuance date[24](index=24&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=18&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management analyzes Q1 2025 financial results, noting decreased operating expenses and net loss due to reduced R&D and G&A, successful **$9.7 million** ATM facility utilization, a **$2.5 million** SEC settlement, and sufficient cash reserves for the next twelve months Comparison of Operations for the Three Months Ended March 31 | ($ in thousands) | 2025 | 2024 | Increase/(Decrease) | | :--- | :--- | :--- | :--- | | Research and development | $1,403 | $2,170 | $(767) | | General and administrative | $1,633 | $2,070 | $(437) | | **Total operating expenses** | **$3,036** | **$4,240** | **$(1,204)** | | **Net loss** | **$(2,732)** | **$(3,843)** | **$1,111** | - Research and development expenses decreased by **$0.8 million**, mainly due to a **$1.0 million** reduction in manufacturing and supplies, partially offset by a **$0.4 million** increase in staffing costs[88](index=88&type=chunk) - General and administrative expenses decreased by **$0.4 million**, primarily due to a **$0.5 million** decrease in professional services[89](index=89&type=chunk) - In Q1 2025, the company sold **9,719,173 shares** of common stock under its At-The-Market (ATM) Sales Agreement, generating net proceeds of approximately **$9.7 million**, and the agreement has since been **fully utilized and terminated**[74](index=74&type=chunk)[94](index=94&type=chunk) - The company reached a final settlement with the SEC regarding a previously disclosed investigation and agreed to pay a one-time civil penalty of **$2.5 million**, with the payment made on April 2, 2025[75](index=75&type=chunk)[68](index=68&type=chunk) - As of March 31, 2025, the company had **$27.7 million** in cash, cash equivalents, and restricted cash, 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) [Quantitative and Qualitative Disclosures About Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company under Rule 12b-2 of the Exchange Act, the company is not required to provide quantitative and qualitative disclosures about market risk - As a **smaller reporting company**, Allarity Therapeutics is **not required** to provide the information under this item[106](index=106&type=chunk) [Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures) Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal control over financial reporting during the quarter - Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were **effective** as of March 31, 2025[107](index=107&type=chunk) - **No changes** in internal control over financial reporting occurred during the quarter ended March 31, 2025, that have **materially affected**, or are reasonably likely to materially affect, internal controls[108](index=108&type=chunk) [PART II—OTHER INFORMATION](index=26&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) [Legal Proceedings](index=26&type=section&id=Item%201.%20Legal%20Proceedings) This section details the company's legal matters, including a **$2.5 million** SEC investigation settlement and the dismissal of a class-action lawsuit in February 2025 - The company settled with the SEC and agreed to pay a one-time civil penalty of **$2.5 million**, which was paid on April 2, 2025[68](index=68&type=chunk)[110](index=110&type=chunk) - A class action lawsuit filed against the company and certain officers on September 13, 2024, was **dismissed** on February 26, 2025[69](index=69&type=chunk) [Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors) The company reports no material changes to previously disclosed risk factors from its Form 10-K, but adds a new risk concerning potential adverse effects of tariffs, trade sanctions, and government actions on global economic conditions and business operations - There are **no material changes** to the risk factors from the Annual Report on Form 10-K for the year ended December 31, 2024[111](index=111&type=chunk) - A **new risk** is disclosed regarding the potential adverse effects of **tariffs, trade sanctions, or similar government actions**, which could **depress economic activity** and **restrict access to potential partners and suppliers**[112](index=112&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=26&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales of equity securities during the reporting period - The company reported 'None' for this item, indicating **no unregistered sales** of equity securities[113](index=113&type=chunk) [Defaults Upon Senior Securities](index=26&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This item is reported as not applicable to the company - The company reported '**Not applicable**' for this item[114](index=114&type=chunk) [Mine Safety Disclosures](index=26&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is reported as not applicable to the company - The company reported '**Not applicable**' for this item[115](index=115&type=chunk) [Other Information](index=26&type=section&id=Item%205.%20Other%20Information) The company confirms no directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during Q1 2025 - **No directors or officers** **adopted or terminated** a **Rule 10b5-1 trading arrangement** during the first quarter of 2025[116](index=116&type=chunk) [Exhibits](index=27&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the quarterly report, including corporate governance documents, CEO and CFO certifications, and Inline XBRL financial data files - The report includes **certifications from the CEO and CFO** under **Section 302 of the Sarbanes-Oxley Act**[119](index=119&type=chunk) - **Inline XBRL documents** (Instance, Schema, Calculation, Definition, Label, and Presentation) are filed as exhibits[119](index=119&type=chunk)[120](index=120&type=chunk)

[First Quarter 2025 Update](index=1&type=section&id=First%20Quarter%202025%20Update) Allarity Therapeutics reported a strong Q1 2025, marked by continued clinical progress for stenoparib, strategic financial strengthening, and resolution of past regulatory matters [Key Highlights](index=1&type=section&id=Key%20Highlights) Allarity Therapeutics reported a strong start to 2025, highlighting continued clinical benefit of stenoparib in ovarian cancer, preparing for two key trials, and strengthening its financial position with approximately **$27 million** in cash and a share repurchase program - Stenoparib continues to show clinical benefit in heavily pre-treated ovarian cancer, with two patients remaining on treatment for over 19 months[1](index=1&type=chunk) - The company is about to begin enrollment in two trials: a self-funded ovarian cancer trial and a Veterans Administration-funded combination trial for small cell lung cancer[2](index=2&type=chunk) - A share repurchase program has been initiated[1](index=1&type=chunk) - The company ended Q1 2025 with a cash and restricted cash balance of approximately **$27 million**[1](index=1&type=chunk) [Clinical and Drug Development Progress](index=1&type=section&id=Clinical%20and%20Drug%20Development%20Progress) The company reported significant clinical and development progress for its lead candidate, stenoparib, and its DRP® platform, demonstrating durable clinical benefit, expanding the DRP® platform, implementing a new trial protocol, and launching a VA-funded combination trial - Stenoparib demonstrated durable clinical benefit as a monotherapy in a Phase 2 trial for advanced ovarian cancer, with two patients receiving treatment for over 19 months[3](index=3&type=chunk) - The DRP® platform was expanded beyond small molecules with the development of a novel DRP® for daratumumab, a targeted antibody therapy, presented at AACR 2025[3](index=3&type=chunk) - A new Phase 2 protocol for stenoparib was implemented for platinum-resistant, advanced ovarian cancer to optimize dose and patient selection, aiming to accelerate the path to regulatory approval[3](index=3&type=chunk) - A new Phase 2 combination trial of stenoparib with temozolomide for recurrent small cell lung cancer (SCLC) was launched, fully funded by the U.S. Veterans Administration[3](index=3&type=chunk) [Financial Strengthening and Corporate Development](index=2&type=section&id=Financial%20Strengthening%20and%20Corporate%20Development) Allarity has taken several steps to strengthen its financial and corporate standing, fully utilizing its ATM offering, authorizing a **$5 million** share repurchase program, actively combating potential illegal short selling, and ending Q1 with a strong cash position of approximately **$27 million** - The At-the-Market (ATM) offering program initiated in March 2024 was fully utilized and has concluded[9](index=9&type=chunk) - A **$5 million** share repurchase program was authorized, and approximately **2 million** shares have been repurchased to date[9](index=9&type=chunk) - The company engaged ShareIntel to investigate potential illegal short selling activities[9](index=9&type=chunk) - Ended Q1 2025 with a cash and restricted cash balance of approximately **$27 million**[9](index=9&type=chunk) [Regulatory and Compliance Resolutions](index=2&type=section&id=Regulatory%20and%20Compliance%20Resolutions) The company has successfully resolved significant past legal and regulatory issues, including finalizing a settlement with the SEC regarding past disclosures and the dismissal of a related class action lawsuit, allowing management to focus on clinical and corporate progress - Finalized a settlement with the SEC, resolving all outstanding matters related to a Wells Notice from July 2024 concerning past disclosures by prior management[9](index=9&type=chunk) - A class action lawsuit was dismissed, closing all related shareholder litigation[9](index=9&type=chunk) [Anticipated Clinical Milestones in 2025](index=2&type=section&id=Anticipated%20Clinical%20Milestones%20in%202025) Allarity expects to achieve key clinical milestones in 2025, with patient enrollment set to begin for two important Phase 2 trials, aiming to provide a definitive foundation for pivotal registration trials for stenoparib in ovarian cancer and to assess a novel combination therapy for small cell lung cancer - In H1 2025, the company expects to begin enrollment for a new protocol for stenoparib in advanced, recurrent, platinum-resistant or platinum-ineligible ovarian cancer[9](index=9&type=chunk) - Patient enrollment is expected to start in Q2-Q3 2025 for the Phase 2 trial evaluating stenoparib in combination with temozolomide for recurrent small cell lung cancer (SCLC)[9](index=9&type=chunk) [First Quarter 2025 Operating Results](index=2&type=section&id=First%20Quarter%202025%20Operating%20Results) For the first quarter of 2025, Allarity reported a significant reduction in operating expenses and net loss compared to the same period in 2024, with cash increasing to **$27.7 million** and both R&D and G&A expenses decreasing, reflecting improved operational efficiency Q1 2025 Financial Highlights (in millions) | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Cash, Cash Equivalents & Restricted Cash | $27.7 | $20.9 (as of 12/31/24) | +$6.8M | | R&D Expenses | $1.4 | $2.2 | -36.4% | | G&A Expenses | $1.6 | $2.1 | -23.8% | | Net Loss | $2.7 | $3.8 | -28.9% | [Company and Product Overview](index=2&type=section&id=Company%20and%20Product%20Overview) This section provides an overview of Allarity Therapeutics, its lead drug candidate stenoparib, and its proprietary Drug Response Predictor (DRP®) companion diagnostic platform [About Stenoparib](index=2&type=section&id=About%20Stenoparib) Stenoparib is an orally available, small-molecule drug that functions as a dual-targeted inhibitor of PARP1/2 and tankyrase 1/2, showing potential as a promising therapeutic for many cancer types, including ovarian cancer, with Allarity holding exclusive global rights - Stenoparib is an oral, small-molecule, dual-targeted inhibitor of PARP1/2 and tankyrase 1/2[7](index=7&type=chunk) - It inhibits the WNT signaling pathway, which is implicated in the development of numerous cancers, giving it broad therapeutic potential[7](index=7&type=chunk) - Allarity has exclusive global rights for stenoparib, which was originally developed by Eisai Co Ltd[7](index=7&type=chunk) [About the Drug Response Predictor – DRP® Companion Diagnostic](index=2&type=section&id=About%20the%20Drug%20Response%20Predictor%20%E2%80%93%20DRP%C2%AE%20Companion%20Diagnostic) The DRP® is Allarity's proprietary companion diagnostic platform used to select cancer patients most likely to benefit from a specific drug by analyzing mRNA expression profiles from tumor biopsies to generate a drug-specific DRP score, aiming to significantly enhance therapeutic benefit rates - The DRP® platform uses a gene expression signature from a patient's cancer to predict their likelihood of responding to a specific drug[8](index=8&type=chunk) - The method is based on comparing mRNA expression profiles from sensitive versus resistant human cancer cell lines[8](index=8&type=chunk)[10](index=10&type=chunk) - The platform has shown a statistically significant ability to predict clinical outcomes in numerous studies and is patented for dozens of anti-cancer drugs[10](index=10&type=chunk) [About Allarity Therapeutics](index=3&type=section&id=About%20Allarity%20Therapeutics) Allarity Therapeutics is a clinical-stage biopharmaceutical company focused on developing personalized cancer treatments, with its primary focus on stenoparib for advanced ovarian cancer, utilizing its proprietary DRP® technology as a companion diagnostic - Allarity is a clinical-stage biopharmaceutical company dedicated to developing personalized cancer treatments[11](index=11&type=chunk) - The company's main focus is developing stenoparib for advanced ovarian cancer, using its DRP® technology as a companion diagnostic[11](index=11&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) This section presents Allarity Therapeutics' condensed consolidated financial statements, including the balance sheets and statements of operations and comprehensive loss, providing a summary of the company's financial position and performance [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, Allarity reported total assets of **$29.7 million** and total liabilities of **$11.1 million**, resulting in total stockholders' equity of **$18.7 million**, a significant increase from **$11.8 million** at the end of 2024, primarily driven by increased cash and additional paid-in capital Balance Sheet Summary (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Total Current Assets** | **$29,422** | **$22,341** | | *Cash and cash equivalents* | *$25,201* | *$19,533* | | *Restricted cash* | *$2,503* | *$—* | | **Total Assets** | **$29,730** | **$22,650** | | **Total Liabilities** | **$11,061** | **$10,839** | | **Total Stockholders' Equity** | **$18,669** | **$11,811** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the three months ended March 31, 2025, Allarity reported a net loss of **$2.7 million**, or (**$0.25**) per share, representing a significant improvement from the net loss of **$3.8 million**, or (**$664.16**) per share, in the same period of 2024, driven by lower operating expenses Statement of Operations Summary (in thousands, except per share data) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $1,403 | $2,170 | | General and administrative | $1,633 | $2,070 | | **Total operating expenses** | **$3,036** | **$4,240** | | **Loss from operations** | **($3,036)** | **($4,240)** | | **Net loss** | **($2,732)** | **($3,843)** | | **Net loss per common share** | **($0.25)** | **($664.16)** | | Weighted average shares outstanding | 11,146,922 | 5,842 |