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].

LinkedIn: https://www.linkedin.com/company/allaritytx/ TARPON SPRINGS, Fla., May 12, 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 the Company's CEO, Thomas Jensen, will deliver a company overview focused on stenoparib and the Company's DRP companion diagnostic platform and conduct one-on-one meetings at the Pharma Partne ...

[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 |

Core Insights - Allarity Therapeutics continues to show clinical benefits of stenoparib in heavily pre-treated ovarian cancer, with two patients on treatment for over 19 months [1][5] - The company has initiated a share repurchase program and ended Q1 2025 with approximately $27 million in cash and restricted cash, indicating financial stability [1][10] Clinical and Drug Development Progress - Enrollment is set to begin in self-funded ovarian cancer trials and a Veterans Administration-funded trial for small cell lung cancer [2] - A new Phase 2 protocol for platinum-resistant advanced ovarian cancer patients has been implemented to optimize dosing and patient selection [5][10] - A new Phase 2 trial evaluating stenoparib in combination with temozolomide for recurrent small cell lung cancer has been launched, fully funded by the U.S. Veterans Administration [5][10] - Updated Phase 2 clinical data presented at the Society of Gynecologic Oncology (SGO) 2025 Annual Meeting shows durable clinical benefits in heavily pre-treated ovarian cancer patients [5] Financial Strengthening and Corporate Development - The company fully utilized its At-the-Market (ATM) offering program initiated in March 2024, concluding the current ATM program [5] - A $5 million share repurchase program has been authorized, with approximately 2 million shares repurchased to date [5] - Cash, cash equivalents, and restricted cash totaled approximately $27.7 million as of March 31, 2025, compared to $20.9 million at the end of 2024 [10] - Research and Development (R&D) expenses for Q1 2025 were $1.4 million, down from $2.2 million in Q1 2024 [10] - General and Administrative (G&A) expenses for Q1 2025 were $1.6 million, down from $2.1 million in Q1 2024 [10] - The net loss for Q1 2025 was $2.7 million, compared to $3.8 million for the same period in 2024 [10]

Core Insights - Allarity Therapeutics has developed a new Drug Response Predictor (DRP) for the monoclonal antibody daratumumab, aimed at identifying multiple myeloma patients who are most likely to benefit from the treatment [1][2][3] Group 1: Drug Response Predictor Development - The daratumumab DRP was created by analyzing gene expression patterns related to sensitivity and resistance to daratumumab-induced antibody-dependent cellular cytotoxicity (ADCC), identifying 53 genes in total [2] - The DRP utilizes single-cell RNA sequencing data and clinical response information from the KYDAR trial, demonstrating its ability to predict treatment outcomes and survival in multiple myeloma patients [2] Group 2: Company Strategy and Technology - The introduction of the daratumumab DRP marks the first application of Allarity's DRP technology for an antibody therapy, expanding its portfolio beyond small-molecule drugs [3] - The company aims to position itself as a strategic partner for third parties looking to target the right patients with existing cancer therapies, enhancing its potential for future collaborations [3] Group 3: Clinical and Regulatory Context - Daratumumab is already approved by the FDA and EMA for treating multiple myeloma, marketed under the brand name Darzalex [5] - Allarity has developed DRPs for numerous anticancer drugs, including its lead program, stenoparib, which is in Phase 2 development for advanced ovarian cancer [6][11]

```markdown [Business Overview and CEO Statement](index=1&type=section&id=Business%20Overview%20and%20CEO%20Statement) In 2024, Allarity Therapeutics underwent a significant transformation, strategically realigning to focus exclusively on advancing stenoparib for advanced ovarian cancer. The company strengthened its financial position, securing a cash runway into 2027, and bolstered its leadership team. Key priorities for 2025 include restarting enrollment in the Phase 2 ovarian cancer trial and initiating a new Phase 2 trial for small cell lung cancer (SCLC) - The CEO highlighted 2024 as a transformational year, marked by a strategic realignment to focus on stenoparib, a simplified capital structure, and a strengthened leadership team[2](index=2&type=chunk) - The company has secured a cash runway expected to fund operations and clinical activities into **2027**[1](index=1&type=chunk)[2](index=2&type=chunk) - The company's cash balance was approximately **$25 million** at the end of Q1 2025, reinforcing its financial stability[1](index=1&type=chunk) [2024 Highlights and Recent Developments](index=1&type=section&id=2024%20Highlights%20and%20Recent%20Developments) During 2024, Allarity executed a full strategic realignment to concentrate solely on developing its novel dual PARP/WNT pathway inhibitor, stenoparib. This involved discontinuing other programs, making significant clinical progress, strengthening the leadership team and financial position, and resolving key regulatory and compliance issues [Clinical and Drug Development Progress](index=1&type=section&id=Clinical%20and%20Drug%20Development%20Progress) The company focused exclusively on stenoparib, discontinuing dovitinib and IXEMPRA®. Stenoparib demonstrated durable clinical benefit in a Phase 2 trial for advanced ovarian cancer, with some patients on treatment for over 17 months. A new protocol was implemented to target platinum-resistant ovarian cancer. Additionally, a new Phase 2 trial for small cell lung cancer (SCLC), fully funded by the U.S. Veterans Administration, was launched to evaluate stenoparib in combination with temozolomide - Executed a full strategic realignment to focus exclusively on the development of stenoparib, discontinuing other clinical programs like dovitinib and IXEMPRA®[3](index=3&type=chunk) - Stenoparib showed durable clinical benefit in the Phase 2 trial for advanced ovarian cancer, with some patients on therapy for more than **17 months**[1](index=1&type=chunk)[3](index=3&type=chunk) - A new Phase 2 trial was launched to evaluate stenoparib with temozolomide for recurrent SCLC, fully funded by the U.S. Veterans Administration[3](index=3&type=chunk) - Updated Phase 2 clinical data presented at the SGO 2025 Annual Meeting demonstrated stenoparib's benefit in heavily pre-treated ovarian cancer patients[4](index=4&type=chunk) [Leadership Changes](index=2&type=section&id=Leadership%20Changes) The company significantly strengthened its management team with several key appointments. Thomas Jensen was named permanent CEO, Jeremy Graff, Ph.D., became President and Chief Development Officer, and Jose Iglesias, M.D., was appointed as Consultant Chief Medical Officer. Other key additions include a new CFO and a Strategic Advisor - Key leadership appointments include Thomas Jensen (CEO), Jeremy Graff, Ph.D. (President and Chief Development Officer), Jose Iglesias, M.D. (Consultant CMO), Alex Epshinsky (CFO), and Jesper Høiland (Strategic Advisor)[10](index=10&type=chunk) [Financial Strengthening and Corporate Development](index=2&type=section&id=Financial%20Strengthening%20and%20Corporate%20Development) Allarity took several steps to bolster its financial health and corporate structure. These include implementing cost-reduction initiatives, securing a European patent for its DRP® companion diagnostic, and establishing a revenue-generating lab unit. The company fully utilized its At-the-Market (ATM) program, which is now concluded, and authorized a $5 million share repurchase program - Strengthened cash balance to provide a runway into **2027**, enabling accelerated development of stenoparib[10](index=10&type=chunk) - The At-the-Market (ATM) offering program initiated in March 2024 was fully utilized and is no longer active[1](index=1&type=chunk)[10](index=10&type=chunk) - Authorized a **$5 million** share repurchase program and initiated efforts to combat potential illegal short selling[10](index=10&type=chunk) - Secured a European patent for the DRP® companion diagnostic for stenoparib and established Allarity Medical Laboratory as a revenue-generating unit[10](index=10&type=chunk) [Regulatory and Compliance Resolutions](index=2&type=section&id=Regulatory%20and%20Compliance%20Resolutions) The company successfully resolved several outstanding regulatory and legal matters. It finalized a settlement with the SEC regarding past disclosures, had a class action lawsuit dismissed, and regained compliance with Nasdaq listing requirements after implementing a 1-for-30 reverse stock split. The equity structure was also streamlined to a single class of common stock - Finalized a settlement with the SEC, resolving all outstanding regulatory matters related to past disclosures on the Dovitinib NDA[10](index=10&type=chunk) - Regained compliance with Nasdaq listing requirements following a **1-for-30** reverse stock split and a successful hearing[10](index=10&type=chunk) - A class action lawsuit was dismissed, closing all related shareholder litigation[10](index=10&type=chunk) [Anticipated Clinical Milestones in 2025](index=2&type=section&id=Anticipated%20Clinical%20Milestones%20in%202025) For 2025, Allarity anticipates two major clinical milestones for stenoparib. Enrollment is expected to begin in the first half of the year for a new protocol in its Phase 2 trial for advanced, platinum-resistant ovarian cancer. Additionally, patient enrollment for the VA-funded Phase 2 combination study in recurrent small cell lung cancer (SCLC) is scheduled to start in Q2-Q3 2025 - Expects to begin enrollment under a new protocol for stenoparib in advanced, recurrent, platinum-resistant ovarian cancer in H1 2025[1](index=1&type=chunk)[10](index=10&type=chunk) - Patient enrollment will initiate in Q2-Q3 2025 for the new Phase 2 trial evaluating stenoparib in combination with temozolomide for recurrent SCLC[1](index=1&type=chunk)[10](index=10&type=chunk) [Full Year 2024 Operating Results](index=2&type=section&id=Full%20Year%202024%20Operating%20Results) For the full year 2024, Allarity reported a significantly improved cash position of $20.9 million. R&D expenses decreased slightly, while G&A expenses rose, partly due to a $2.5 million SEC settlement accrual. The net loss increased to $24.5 million, largely driven by a $9.7 million non-cash impairment charge and costs related to the SEC investigation Key Financial Metrics | Financial Metric | 2024 | 2023 | Change | Source Chunk(s) | | :--- | :--- | :--- | :--- | :--- | | Cash and cash receivables | $20.9 million | $0.2 million | +$20.7 million | 9 | | R&D Expenses | $6.1 million | $7.1 million | -$1.0 million | 11 | | G&A Expenses | $11.4 million | $10.0 million | +$1.4 million | 11 | | Net Loss | $24.5 million | $11.9 million | +$12.6 million | 12 | - The increase in net loss from 2023 to 2024 is primarily due to a **$9.7 million** non-cash intangible asset impairment charge and costs from the SEC investigation, including a **$2.5 million** settlement[11](index=11&type=chunk)[12](index=12&type=chunk) [Financial Statements](index=5&type=section&id=Financial%20Statements) The consolidated financial statements for the year ended December 31, 2024, reflect the company's strategic and financial realignment. The balance sheet shows a significant increase in cash and total assets, coupled with a decrease in total liabilities, resulting in a shift from a stockholders' deficit to positive equity. The statement of operations details the expenses, including a major non-cash impairment charge, that contributed to the net loss for the year [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) As of December 31, 2024, Allarity's balance sheet showed total assets of $22.7 million, a significant increase from $11.9 million in 2023, primarily driven by a rise in cash to $19.5 million. Total liabilities decreased to $10.8 million from $14.6 million. Consequently, the company moved from a stockholders' deficit of $2.8 million in 2023 to a positive stockholders' equity of $11.8 million in 2024 Consolidated Balance Sheets | Balance Sheet (in thousands) | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Total current assets** | $22,341 | $1,971 | | **Total assets** | $22,650 | $11,862 | | **Total liabilities** | $10,839 | $14,613 | | **Total stockholders' equity (deficit)** | $11,811 | $(2,751) | - Intangible assets were fully impaired, decreasing from **$9.9 million** in 2023 to zero in 2024[20](index=20&type=chunk) [Consolidated Statements of Operations](index=6&type=section&id=Consolidated%20Statements%20of%20Operations) For the year ended December 31, 2024, the company reported total operating expenses of $27.2 million, up from $17.1 million in 2023. This increase was largely due to a $9.7 million non-cash impairment charge on intangible assets. The net loss was $24.5 million, or ($15.65) per share, compared to a net loss of $11.9 million, or ($6,031.31) per share, in 2023. The significant change in EPS reflects changes in the number of outstanding shares following corporate actions Consolidated Statements of Operations | Statement of Operations (in thousands) | 2024 | 2023 | | :--- | :--- | :--- | | Total operating expenses | $27,241 | $17,129 | | Loss from operations | $(27,241) | $(17,129) | | Net loss | $(24,515) | $(11,901) | | Net loss per common share, basic and diluted | $(15.65) | $(6,031.31) | - A non-cash impairment charge of **$9.7 million** on intangible assets was a major contributor to the operating loss in 2024[22](index=22&type=chunk) - Other income included a **$2.7 million** positive change in the fair value of warrant derivative liabilities[22](index=22&type=chunk) [Company and Product Overview](index=3&type=section&id=Company%20and%20Product%20Overview) Allarity Therapeutics is a clinical-stage biopharmaceutical company focused on personalized cancer treatments. Its lead asset is stenoparib, a novel PARP/tankyrase inhibitor for advanced ovarian cancer. The company utilizes its proprietary DRP® companion diagnostic technology to select patients who are most likely to benefit from its therapies - Allarity Therapeutics is a clinical-stage biopharmaceutical company headquartered in the U.S. with a research facility in Denmark, dedicated to developing personalized cancer treatments[15](index=15&type=chunk) [About Stenoparib](index=3&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. By inhibiting PARP and blocking the WNT signaling pathway (regulated by tankyrases), stenoparib shows potential as a therapeutic for numerous cancer types. Allarity holds exclusive global rights for the drug, which was originally developed by Eisai Co. Ltd - Stenoparib is a dual-targeted inhibitor of PARP1/2 and tankyrase 1/2, which plays a role in regulating the WNT signaling pathway implicated in many cancers[13](index=13&type=chunk) - Allarity has secured exclusive global rights for the development and commercialization of stenoparib, originally developed by Eisai Co. Ltd[13](index=13&type=chunk) [About the Drug Response Predictor – DRP® Companion Diagnostic](index=3&type=section&id=About%20the%20Drug%20Response%20Predictor%20%E2%80%93%20DRP%C2%AE%20Companion%20Diagnostic) The DRP® is Allarity's companion diagnostic platform used to select patients who are likely to have a high probability of benefiting from a specific drug. The method is based on analyzing the messenger RNA (mRNA) expression profiles from patient biopsies to identify a predictive gene expression signature. The DRP® platform has shown statistically significant predictive ability in numerous clinical studies and is patented for use with dozens of anti-cancer drugs - The DRP® platform uses a drug-specific gene expression signature from a patient's cancer biopsy to predict the likelihood of therapeutic benefit[14](index=14&type=chunk) - The method is based on messenger RNA (mRNA) expression profiles and has been extensively published and patented for dozens of anti-cancer drugs[14](index=14&type=chunk) ```

Core Insights - Allarity Therapeutics has made significant advancements in the development of stenoparib, a dual PARP/WNT pathway inhibitor, particularly for advanced ovarian cancer treatment [1][2] - The company has undergone a strategic realignment to focus exclusively on stenoparib, discontinuing other clinical programs, which has accelerated progress in its clinical trials [2][3] - Financially, Allarity has strengthened its position, with a cash balance of approximately $25 million at the end of Q1 2025, providing a runway into 2027 for ongoing clinical activities [2][9] Clinical and Drug Development Progress - In 2024, Allarity executed a strategic realignment to focus solely on stenoparib, leading to accelerated progress in its clinical program [2] - The company reported a cash and cash receivable balance of $20.9 million as of December 31, 2024, which is expected to fund operations into 2027 [2][9] - Stenoparib has shown durable clinical benefits in heavily pre-treated ovarian cancer patients, with some patients remaining on treatment for over 17 months [3][4] Leadership Changes - Thomas Jensen has been appointed as the permanent CEO, transitioning from interim status, with a focus on advancing Allarity's strategic and clinical goals [8] - Key appointments include Jeremy Graff as President and Chief Development Officer, and Jose Iglesias as Consultant Chief Medical Officer, both bringing extensive oncology experience [8] Financial Strengthening and Corporate Development - The company reported a net loss of $24.5 million for 2024, an increase from $11.9 million in 2023, largely due to a non-cash impairment charge and costs related to an SEC investigation [10][21] - Allarity has implemented cost-reduction initiatives to strengthen financial sustainability while prioritizing stenoparib's advancement [8] - A $5 million share repurchase program has been authorized to reinforce long-term shareholder value [8] Regulatory and Compliance Resolutions - Allarity has resolved outstanding regulatory matters with the SEC related to past disclosures, allowing the company to focus on clinical and corporate progress [8] - The company regained compliance with Nasdaq listing requirements following a successful hearing [8]

Core Viewpoint - Allarity Therapeutics has engaged Shareholder Intelligence Services to investigate potential illegal naked short selling and trading irregularities in its stock, emphasizing its commitment to protecting shareholder value and ensuring fair trading practices [1][2][3]. Group 1: Engagement with ShareIntel - The collaboration with ShareIntel aims to monitor trading activities and detect unusual short-selling patterns, utilizing ShareIntel's DRIL-Down™ technology for compliance-driven data analytics [2][3]. - Allarity will take corrective actions, including legal recourse if necessary, based on the findings from ShareIntel's investigation [2][3]. Group 2: CEO's Statement - The CEO of Allarity highlighted the importance of this engagement in fostering market confidence and addressing notable stock volatility observed by the company [3]. - The company aims to ensure that its shares are traded fairly and free from manipulation as it advances the clinical development of stenoparib [3]. Group 3: About Stenoparib - Stenoparib is a dual-targeted inhibitor of PARP1/2 and tankyrase 1/2, showing potential as a therapeutic for various cancers, particularly ovarian cancer [4]. - The drug's unique mechanism involves inhibiting PARP and blocking Wnt pathway activation, which is significant in cancer progression [4]. Group 4: Company Overview - Allarity Therapeutics is focused on developing personalized cancer treatments and has secured exclusive global rights for the development and commercialization of stenoparib [5]. - The company utilizes its DRP technology to create companion diagnostics aimed at selecting patients who would benefit most from stenoparib [5].