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Galmed Pharmaceuticals(GLMD) - 2023 Q3 - Quarterly Report

Financial Position - As of September 30, 2023, the company reported current assets of $14.2 million, a decrease from $14.7 million at December 31, 2022, primarily due to a reduction in cash and cash equivalents from $2 million to $1.5 million[46]. - As of September 30, 2023, the company had cash and cash equivalents of approximately $1.5 million, short-term deposits of $1.9 million, and marketable debt securities of approximately $9.9 million, totaling approximately $13.4 million[65]. - The accumulated deficit as of September 30, 2023, was approximately $191.0 million, with positive working capital of approximately $12.1 million[64]. Operating Losses and Expenses - The company expects to continue incurring operating losses over the next several years and anticipates needing additional funds to further develop its research and development programs[47]. - General and administrative expenses are anticipated to increase due to costs associated with being a public company and compliance with Nasdaq and SEC requirements[53]. - Research and development expenses are expected to remain the primary expense as the company continues to develop Aramchol, with costs primarily driven by the number and duration of pre-clinical and clinical studies[49]. - Research and development expenses for the three and nine months ended September 30, 2023, were approximately $0.6 million and $2.4 million, representing decreases of 86% and 79% compared to $4.2 million and $11.6 million in the same periods of 2022[57]. - General and administrative expenses for the same periods were approximately $0.9 million and $2.9 million, reflecting decreases of 18% and 19% from $1.1 million and $3.6 million in 2022[59]. - The operating loss for the three and nine months ended September 30, 2023, was approximately $1.5 million and $5.3 million, a decrease of 72% and 65% compared to $5.4 million and $15.2 million in 2022[61]. - The net loss for the three and nine months ended September 30, 2023, was approximately $1.5 million and $4.9 million, representing decreases of 72% and 68% from $5.4 million and $15.2 million in 2022[63]. Cash Flow and Financing - The company experienced negative cash flow from operating activities of approximately $5.2 million for the nine months ended September 30, 2023, compared to negative cash flow of approximately $14.5 million for the same period in 2022[66]. - The company raised approximately $6.2 million in financing activities during the nine months ended September 30, 2023, primarily from a public offering in July 2023[68]. - The company plans to seek additional funding through various means, including debt or equity financings, to support ongoing research and development efforts[70]. Clinical Programs and Strategic Initiatives - The company initiated a new clinical program for Aramchol meglumine targeting Primary Sclerosing Cholangitis (PSC), with an estimated delay of 6-9 months in the initiation of the Phase 2 study due to the ongoing conflict in Israel[43]. - The ARMOR Study for Aramchol has transitioned to an open-label part, and the company does not expect to initiate the second part of the study in the near term[42]. - The company is no longer evaluating strategic alternatives following the initiation of the PSC clinical program and investment in OnKai[45]. - The company entered into a definitive agreement for a $1.5 million equity investment in OnKai Inc., which will enhance its strategic operations in underserved healthcare markets[44]. - The company holds approximately 23.9% of the outstanding share capital of OnKai following the recent investment round[44]. Compliance and Listing Requirements - Nasdaq notified the company on September 22, 2023, that it has 180 days to regain compliance with the minimum bid price requirement of $1.00 per share[82]. - The company must achieve a closing bid price of at least $1.00 for a minimum of 10 consecutive business days to regain compliance by March 18, 2024[82]. - If compliance is not regained by the deadline, the company may be eligible for an additional 180 days under certain conditions[82]. - Failure to meet Nasdaq's continued listing requirements could lead to delisting, negatively impacting the share price and liquidity[83]. - The company cannot assure that actions taken to restore compliance will stabilize the market price or improve liquidity of its ordinary shares[83].