Galera(GRTX) - 2024 Q1 - Quarterly Results

Company Overview & Strategic Updates Galera Therapeutics is a clinical-stage biopharmaceutical company evaluating strategic alternatives and implementing stockholder protection measures Introduction and Strategic Review Galera Therapeutics, a clinical-stage biopharmaceutical company, is evaluating strategic alternatives including mergers, asset sales, or dissolution to maximize stockholder value - Galera Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapeutics to transform radiotherapy in cancer[1] - The company is actively evaluating potential strategic alternatives, including mergers, asset sales, divestiture, licensing arrangements, or other strategic transactions, which may encompass a development path for avasopasem or culminate in company dissolution[2] General Corporate Updates Galera continues its strategic review with Stifel, Nicolaus & Company, Inc. and adopted a stockholder rights agreement to protect stockholder interests - Galera remains actively engaged with Stifel, Nicolaus & Company, Inc. to undertake a comprehensive review of strategic alternatives for the Company and its portfolio, with no fixed timeline for completion[4] - On May 3, 2024, the Board of Directors adopted a limited duration stockholder rights agreement to protect stockholder interests by reducing the likelihood of control acquisition without an appropriate premium[4] About Galera Therapeutics Galera Therapeutics historically developed novel therapeutic candidates like avasopasem and rucosopasem to transform radiotherapy in cancer - Galera Therapeutics historically focused on developing novel, proprietary therapeutic candidates with the potential to transform radiotherapy in cancer[5] - Avasopasem manganese (avasopasem) was being developed for radiation-induced and cisplatin-related toxicities, receiving FDA Fast Track and Breakthrough Therapy designations[5] - Rucosopasem manganese (rucosopasem) was being developed to augment anti-cancer efficacy in non-small cell lung cancer and locally advanced pancreatic cancer, receiving Orphan Drug designation from the FDA and EMA[5] First Quarter 2024 Financial Results Galera reported significantly reduced operating expenses and net loss in Q1 2024, with cash expected to fund operations into Q3 2025 Financial Highlights Galera significantly reduced Q1 2024 operating expenses and net loss, with $13.5 million cash expected to fund operations into Q3 2025 First Quarter Financial Performance | Metric | Q1 2024 (Millions USD) | Q1 2023 (Millions USD) | Change (YoY) | | :----- | :--------------------- | :--------------------- | :----------- | | R&D Expenses | $1.5 | $7.3 | -79.5% | | G&A Expenses | $3.1 | $6.6 | -53.0% | | Net Loss | $(4.4) | $(17.7) | -75.1% | | Net Loss Per Share (USD) | $(0.08) | $(0.50) | -84.0% | - The decrease in research and development expenses was primarily attributable to the cessation of all clinical trial activity and suspension of clinical development for product candidates[3] - The decrease in general and administrative expenses was primarily due to the cessation of avasopasem commercial preparations and medical affairs activities, and reduced personnel-related expenses from an August 2023 workforce reduction[7] - As of March 31, 2024, Galera had cash and cash equivalents of $13.5 million, which are expected to fund operating expenses and capital expenditure requirements into the third quarter of 2025[7] Consolidated Statements of Operations Galera's consolidated statements of operations for the three months ended March 31, 2024, reflect a substantial reduction in operating expenses and net loss compared to the prior year, driven by decreased research and development and general and administrative costs Consolidated Statements of Operations Data | Metric (in thousands) | 2024 | 2023 | | :-------------------- | :--- | :--- | | Research and development | $1,488 | $7,272 | | General and administrative | $3,089 | $6,609 | | Loss from operations | $(4,577) | $(13,881) | | Other income (expense), net | $196 | $(3,829) | | Net loss | $(4,381) | $(17,710) | | Net loss per share of common stock, basic and diluted | $(0.08) | $(0.50) | | Weighted average common shares outstanding, basic and diluted | 54,392,170 | 35,196,134 | Selected Consolidated Balance Sheet Data As of March 31, 2024, Galera's selected consolidated balance sheet data shows a decrease in cash and cash equivalents, total assets, and total current liabilities compared to December 31, 2023, while total stockholders' deficit increased Selected Consolidated Balance Sheet Data | Metric (in thousands) | March 31, 2024 | December 31, 2023 | | :-------------------- | :------------- | :---------------- | | Cash and cash equivalents | $13,466 | $18,257 | | Total assets | $19,651 | $26,141 | | Total current liabilities | $2,013 | $4,957 | | Total liabilities | $154,342 | $157,326 | | Total stockholders' deficit | $(134,691) | $(131,185) | Forward-Looking Statements This section outlines forward-looking statements subject to significant risks, including funding needs, clinical trial uncertainties, and the potential for operational cessation Disclaimer and Key Risks Forward-looking statements are subject to significant risks including funding, clinical trials, regulatory approvals, and the potential inability to secure strategic alternatives or additional funding - Forward-looking statements are subject to known and unknown risks, uncertainties, and other important factors that may cause Galera's actual results, performance, or achievements to be materially different[6] - Key risks include limited operating history, anticipated continued losses, the need for substantial funding, dependence on avasopasem, uncertainties in clinical trials, regulatory approval risks, and the inability to enter into any desired strategic alternative or partnership, which could lead to the cessation of operations[6][8] - Galera's ability to fund its operating expenses and capital expenditure requirements into the third quarter of 2025 is a forward-looking statement[6] Investor & Media Contacts This section provides essential contact information for investor relations and media inquiries for Galera Therapeutics Contact Information This section provides contact details for investor relations and media inquiries for Galera Therapeutics, Inc - Investor contacts are Christopher Degnan from Galera Therapeutics, Inc. and William Windham from Solebury Strategic Communications[12] - Media contact is Timothy Biba from Solebury Strategic Communications[12]