Allarity Therapeutics(US:ALLR)2025-03-31 20:10markdown [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)