Allarity Therapeutics(ALLR) - 2025 Q1 - Quarterly Results

First Quarter 2025 Update 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 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] - 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] - A share repurchase program has been initiated[1] - The company ended Q1 2025 with a cash and restricted cash balance of approximately $27 million[1] Clinical and Drug Development Progress 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] - 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] - 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] - 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] Financial Strengthening and Corporate Development 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] - A $5 million share repurchase program was authorized, and approximately 2 million shares have been repurchased to date[9] - The company engaged ShareIntel to investigate potential illegal short selling activities[9] - Ended Q1 2025 with a cash and restricted cash balance of approximately $27 million[9] Regulatory and Compliance Resolutions 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] - A class action lawsuit was dismissed, closing all related shareholder litigation[9] Anticipated Clinical Milestones in 2025 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] - 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] First Quarter 2025 Operating Results 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 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 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] - It inhibits the WNT signaling pathway, which is implicated in the development of numerous cancers, giving it broad therapeutic potential[7] - Allarity has exclusive global rights for stenoparib, which was originally developed by Eisai Co Ltd[7] About the Drug Response Predictor – DRP® Companion Diagnostic 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] - The method is based on comparing mRNA expression profiles from sensitive versus resistant human cancer cell lines[8][10] - 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] About Allarity Therapeutics 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] - The company's main focus is developing stenoparib for advanced ovarian cancer, using its DRP® technology as a companion diagnostic[11] Financial Statements 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 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 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 |