Gain Therapeutics(GANX) - 2025 Q1 - Quarterly Report

Financial Performance - Net loss for the three months ended March 31, 2025, was $4.53 million, compared to a net loss of $4.01 million for the same period in 2024, reflecting an increase in loss of approximately 12.9%[16] - Comprehensive loss for Q1 2025 was $4.40 million, compared to $4.24 million in Q1 2024, indicating an increase of about 3.9%[20] - Cash used in operating activities for Q1 2025 was $3.82 million, compared to $3.59 million in Q1 2024, an increase of approximately 6.4%[28] - The company has incurred an accumulated deficit of $81.2 million as of March 31, 2025, with recurring losses and negative cash flows from operations[165] - Net loss for the three months ended March 31, 2025, was $4.5 million, an increase of $0.5 million compared to a net loss of $4.0 million for the same period in 2024[182] Assets and Liabilities - Total assets decreased to $11.62 million as of March 31, 2025, from $12.12 million as of December 31, 2024, representing a decline of approximately 4.1%[13] - Current liabilities increased significantly to $5.03 million as of March 31, 2025, compared to $3.91 million as of December 31, 2024, marking an increase of about 28.6%[13] - Total stockholders' equity decreased to $5.78 million as of March 31, 2025, from $7.34 million as of December 31, 2024, a decline of approximately 21.2%[13] - Total prepaid expenses and other current assets increased to $1,833,659 as of March 31, 2025, up from $945,536 on December 31, 2024, representing a growth of 93.9%[104] - Accounts payable increased to $2.2 million as of March 31, 2025, compared to $0.9 million on December 31, 2024, indicating a rise of 144.4%[112] Cash and Financing - Cash and cash equivalents at the end of Q1 2025 were $9.07 million, down from $10.39 million at the end of Q4 2024, a decrease of approximately 12.7%[13] - As of March 31, 2025, the Company has $9.1 million in cash and cash equivalents, which is insufficient to fund operations for the next 12 months[48] - The company raised gross proceeds of $2.49 million from the sale of 1,094,701 shares under the 2024 ATM Program at an average price of $2.28 per share[122] - The public offering completed in June 2024 resulted in gross proceeds of $11.5 million, including $1.2 million in underwriting commissions and expenses[126] - Cash provided by financing activities was $2.4 million for the three months ended March 31, 2025, due to net proceeds from the issuance of shares[197] Research and Development - The Company is developing GT-02287 for Parkinson's disease, showing significant preclinical efficacy in restoring GCase function and improving neuronal health[34] - In a Phase 1 study with 72 participants, GT-02287 was safe and well tolerated at the highest planned dose, supporting further development in GBA1 Parkinson's patients[34] - Research and development expenses decreased to $2.26 million in Q1 2025 from $2.51 million in Q1 2024, a reduction of about 9.9%[16] - The Company started a Phase 1 Clinical Trial for its lead program in Parkinson's disease in Australia, supported by the R&DTI program[98] - The company plans to continue advancing existing research programs and initiate additional programs targeting allosteric binding sites identified with the Magellan™ platform[150] Grants and Income - The Company received a grant of $1.3 million from Eurostars and Innosuisse, with $0.45 million allocated to the Company for its alpha-1 antitrypsin deficiency program[95] - In May 2023, the Company was awarded a grant of $2.8 million under the Swiss Accelerator program, later amended to approximately $2.0 million due to project scope changes[96] - The Company recorded deferred grant income of $0.2 million and $0.3 million as of March 31, 2025 and December 31, 2024, respectively[97] - The R&DTI program provided a cash refund based on a percentage of eligible research and development activities, resulting in a reduction to research and development expenses of $0.2 million during the three months ended March 31, 2025[98] Risks and Concerns - The Company anticipates incurring additional losses until it can generate significant sales from its product candidates currently in development[45] - If unable to secure additional funding, the Company may need to suspend or terminate ongoing development activities, impacting shareholder investments[51] - The company reported substantial doubt about its ability to continue as a going concern due to insufficient cash resources to fund operations for one year from the issuance of the financial statements[189] - The Company faces risks typical of early-stage biotechnology firms, including reliance on key personnel and the need for significant additional capital[37] Stock and Compensation - The weighted average common stock increased to 28,685,417 shares in Q1 2025 from 17,978,951 shares in Q1 2024, an increase of approximately 59.7%[16] - The total stock-based compensation expense for the three months ended March 31, 2025, was $419,504, significantly higher than $190,424 for the same period in 2024[137] - The company granted 1,099,325 stock options during the three months ended March 31, 2025, with a weighted average grant date fair value of $1.67[133] - As of March 31, 2025, the company had unrecognized compensation costs associated with stock options grants amounting to $4.3 million, expected to be recognized over 4.0 years[133] Management and Controls - Management plans to raise additional capital through private/public equity financings and is reviewing cost structures to optimize expenditures[49] - The company maintains effective disclosure controls and procedures as of March 31, 2025, ensuring timely reporting and management communication[208] - No changes in internal control over financial reporting were reported during the period that materially affected internal controls[210] - Management acknowledges that controls can only provide reasonable assurance and are subject to inherent limitations[211]