Galera(GRTX) - 2023 Q4 - Annual Results

Corporate Overview and Strategic Direction Galera is implementing cost-saving measures and exploring strategic alternatives, including potential dissolution, after FDA feedback and program discontinuations Strategic Review and Corporate Actions Galera implemented significant cost-saving measures, including a 70% workforce reduction, and is exploring strategic alternatives - The company is exploring strategic options to maximize shareholder value, including a potential new development path for avasopasem or the dissolution of the company[2] - In August 2023, the company reduced its workforce by approximately 70% to lower operational costs[4] - Stifel, Nicolaus & Company, Inc. was engaged in October 2023 as a financial advisor to assist in reviewing strategic alternatives[4] Clinical Development Updates Clinical development updates include FDA's requirement for an additional avasopasem trial and the discontinuation of rucosopasem programs Avasopasem Program Updates FDA issued a CRL for avasopasem NDA, requiring an additional trial for SOM, while ROMAN trial showed 50% CKD reduction - In August 2023, the FDA issued a Complete Response Letter (CRL) for the avasopasem NDA, deeming the Phase 2b and Phase 3 data insufficient for approval[4] - A Type A meeting with the FDA in September 2023 confirmed the need for an additional Phase 3 trial to support an NDA resubmission for avasopasem[8] - Data presented at ASN Kidney Week 2023 showed a 50% reduction in the incidence of cisplatin-related Chronic Kidney Disease (CKD) at one year in the avasopasem arm compared to placebo[5] Rucosopasem Program Updates Galera discontinued its rucosopasem development programs, halting GRECO-2 due to futility and subsequently GRECO-1 - The Phase 2b GRECO-2 trial of rucosopasem in patients with LAPC was halted in October 2023 following an unsuccessful futility analysis[9] - Following the GRECO-2 futility analysis, the company also decided to halt the Phase 1/2 GRECO-1 trial of rucosopasem in patients with NSCLC[6] Financial Performance The company significantly reduced operating expenses and net loss in Q4 2023, with a modest improvement in full-year net loss Fourth Quarter 2023 Financial Highlights In Q4 2023, Galera significantly reduced operating expenses and net loss, ending the year with $18.3 million in cash Q4 2023 vs Q4 2022 Financials (in thousands, except per share data) | Metric | Q4 2023 | Q4 2022 | | :--- | :--- | :--- | | Research & Development Expenses | $3,189 | $8,137 | | General & Administrative Expenses | $1,987 | $5,021 | | Net Loss | $(5,587) | $(16,188) | | Net Loss Per Share | $(0.10) | $(0.58) | - As of December 31, 2023, the company had cash and cash equivalents of $18.3 million, which is expected to fund operations into the second quarter of 2025[9] Full Year 2023 Financial Highlights For FY2023, R&D expenses decreased, G&A rose, and the net loss was $59.1 million, including $2.3 million in restructuring charges Full Year 2023 vs 2022 Financials (in thousands, except per share data) | Metric | FY 2023 | FY 2022 | | :--- | :--- | :--- | | Research & Development Expenses | $24,115 | $31,012 | | General & Administrative Expenses | $22,836 | $20,214 | | Net Loss | $(59,082) | $(62,222) | | Net Loss Per Share | $(1.33) | $(2.30) | - The company incurred restructuring-related charges of $2.3 million in Q3 2023, primarily for severance and employee benefits from the workforce reduction[13] Consolidated Financial Statements This section presents detailed Consolidated Statements of Operations and Balance Sheet Data for 2023 and 2022 Consolidated Statements of Operations (in thousands, except per share data) | | Three Months Ended Dec 31, | Year Ended Dec 31, | | :--- | :--- | :--- | | | 2023 | 2022 | 2023 | 2022 | | Research and development | $3,189 | $8,137 | $24,115 | $31,012 | | General and administrative | $1,987 | $5,021 | $22,836 | $20,214 | | Restructuring costs | $— | $— | $2,309 | $— | | Loss from operations | $(5,176) | $(13,158) | $(49,260) | $(51,226) | | Net Loss | $(5,587) | $(16,188) | $(59,082) | $(62,222) | | Net loss per share | $(0.10) | $(0.58) | $(1.33) | $(2.30) | Selected Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | Cash, cash equivalents, and short-term investments | $18,257 | $31,597 | | Total assets | $26,141 | $44,036 | | Total liabilities | $157,326 | $153,217 | | Total stockholders' deficit | $(131,185) | $(109,181) |