Galera(US:GRTX)2023-11-14 12:53Financial Performance - The company reported a net loss of $15,073,000 for the three months ended September 30, 2023, compared to a net loss of $16,033,000 for the same period in 2022, indicating an improvement of about 6%[19] - The company reported a net loss of $53.495 million for the nine months ended September 30, 2023, compared to a net loss of $46.034 million for the same period in 2022[24] - The comprehensive loss for the three months ended September 30, 2023, was $15,078,000, slightly improved from a comprehensive loss of $16,016,000 in the same period of 2022, indicating a reduction of about 5.9%[19] - Net loss for Q3 2023 was $15.1 million, a decrease of $0.96 million compared to a net loss of $16.0 million in Q3 2022[120] Assets and Cash Position - As of September 30, 2023, total assets decreased to $37,779,000 from $44,036,000 as of December 31, 2022, representing a decline of approximately 14.3%[13] - The company had cash and cash equivalents of $24,379,000 as of September 30, 2023, significantly up from $4,266,000 at the end of 2022, representing an increase of approximately 471.5%[13] - The company had cash, cash equivalents, and restricted cash of $24.429 million at the end of the period, up from $12.780 million at the end of September 2022[24] - As of September 30, 2023, the company had $28.4 million in cash, cash equivalents, and short-term investments, with an accumulated deficit of $431.8 million[120] - The company expects its existing cash and short-term investments will fund operations into 2025[33] Expenses - Research and development expenses for the three months ended September 30, 2023, were $6,093,000, down from $8,105,000 in the same period of 2022, reflecting a decrease of approximately 24.8%[15] - General and administrative expenses for the nine months ended September 30, 2023, were $20,849,000, compared to $15,193,000 for the same period in 2022, reflecting an increase of approximately 37.5%[15] - Research and development expenses for the nine months ended September 30, 2023, totaled $20.9 million, compared to $22.8 million for the same period in 2022[98] - General and administrative expenses increased by $0.1 million from $4.9 million in Q3 2022 to $5.0 million in Q3 2023, mainly due to avasopasem commercial preparations and increased legal expenses[111] Restructuring and Workforce Changes - The company incurred restructuring costs of $2,309,000 during the three months ended September 30, 2023, which were not present in the same period of the previous year[15] - The company incurred total restructuring-related charges of $2.3 million during the three months ended September 30, 2023, due to a workforce reduction of approximately 70%[45] - A reduction in force was implemented in August 2023, affecting 22 employees, or 70% of the workforce, incurring a charge of $2.3 million primarily for severance and related costs[173] Strategic Initiatives - The company is exploring strategic alternatives, including potential mergers or asset divestitures, to maximize shareholder value[31] - The company announced the decision to halt the GRECO-1 and GRECO-2 trials following a futility analysis, aiming to conserve cash[30] - The company has engaged Stifel, Nicolaus & Company, Inc. as its financial advisor to assist in reviewing strategic alternatives[31] - The company is concurrently evaluating strategic alternatives for the continued development of avasopasem and rucosopasem[169] Compliance and Regulatory Issues - As of September 22, 2023, the company was not in compliance with Nasdaq's minimum Market Value of Listed Securities of $50 million and the minimum bid price requirement of $1.00 per share[89] - The company has until March 20, 2024, to regain compliance with Nasdaq's listing requirements[89] - The company received a Complete Response Letter (CRL) from the FDA on August 9, 2023, regarding the NDA for avasopasem, indicating that additional clinical trials are required for resubmission[157] - The FDA requires an additional Phase 3 trial to confirm the efficacy and safety of avasopasem for radiotherapy-induced SOM, which may delay the approval process[165] Funding and Financial Obligations - The company may need substantial additional funding to meet financial obligations and pursue growth strategies, which could be impacted by market conditions[149][152] - Future funding requirements will depend on various factors, including the outcome of strategic alternatives being explored, such as mergers or partnerships[128] - The company entered into a Royalty Agreement with Blackstone Life Sciences, potentially receiving up to $117.5 million based on clinical milestones achieved in the ROMAN trial[133][134] Legal Matters - The company is involved in a lawsuit against Alira Health Clinical, LLC and IQVIA Biotech, LLC related to a breach of contract in the Phase 3 ROMAN trial[146]