Gain Therapeutics(US:GANX)2025-08-12 20:05Financial Performance - Net loss for the three months ended June 30, 2025, was $5,809,087, compared to a net loss of $8,143,078 for the same period in 2024, indicating a reduction of approximately 28.8%[16] - The company reported a comprehensive loss of $5,105,139 for the three months ended June 30, 2025, compared to $8,152,479 for the same period in 2024, reflecting a decrease of approximately 37.5%[20] - For the six months ended June 30, 2024, the net loss was $12,157,272, compared to a net loss of $10,339,145 for the same period in 2025, indicating a decrease in losses year-over-year[31] - The company incurred net losses of $5.8 million and $10.3 million for the three and six months ended June 30, 2025, respectively[170] - Net loss for the three months ended June 30, 2025, was $5.8 million, a decrease of $2.3 million compared to a net loss of $8.1 million for the same period in 2024[187] Assets and Liabilities - Total assets decreased from $12,123,884 as of December 31, 2024, to $9,833,980 as of June 30, 2025, representing a decline of approximately 19.9%[13] - Current liabilities increased significantly from $3,911,321 as of December 31, 2024, to $5,197,044 as of June 30, 2025, an increase of about 32.9%[13] - Cash and cash equivalents decreased from $10,385,863 as of December 31, 2024, to $6,694,136 as of June 30, 2025, a decline of about 35.0%[13] - Total stockholders' equity decreased from $7,339,574 as of December 31, 2024, to $3,696,050 as of June 30, 2025, a decrease of approximately 49.7%[13] - As of June 30, 2025, accounts payable amounted to $2.7 million, an increase from $0.9 million as of December 31, 2024[116] Cash Flow and Financing - Cash used in operating activities for the six months ended June 30, 2024, was $9,342,986, while for the same period in 2025, it was $8,920,509, showing a slight improvement in cash flow management[31] - Cash provided by financing activities for the six months ended June 30, 2025, was $4.9 million, primarily from the issuance of shares under the 2024 ATM Program[203] - The company raised $4,910,240 from the issuance of shares in an ATM offering during the six months ended June 30, 2025[31] - The public offering completed in June 2024 resulted in gross proceeds of $11.5 million, including $1.2 million in underwriting commissions and expenses[131] - The company completed a public offering in July 2025, raising gross proceeds of $7.0 million from the sale of 4,501,640 shares and warrants[150] Research and Development - Research and development expenses for the six months ended June 30, 2025, were $5,015,983, down from $6,944,537 in the same period of 2024, a decrease of about 27.8%[16] - The company plans to continue advancing existing research programs and initiate additional programs targeting allosteric binding sites identified with its Magellan™ platform[154] - The clinical stage product candidate GT-02287 is being developed for the treatment of Parkinson's disease, with preclinical data showing restoration of glucocerebrosidase function and improvement in dopaminergic neuron survival[35] - GT-02287, a clinical stage product candidate for Parkinson's disease, demonstrated a 53% mean increase in GCase activity among healthy volunteers in a Phase 1 study[155] - The company anticipates significant research and development expenses to support ongoing clinical trials and product development[161] Capital Requirements and Going Concern - The company anticipates needing substantial additional capital to fund operations and develop its product candidates[46] - There is substantial doubt about the Company's ability to continue as a going concern, necessitating additional capital to sustain operations beyond the first quarter of 2026[49] - The company has substantial doubt about its ability to continue as a going concern without additional financing[195] - Future funding requirements will depend on various factors, including operational needs for preclinical studies and clinical trials, which are currently uncertain[207] - The company expects to finance operations through public and private equity offerings, debt financings, and collaborations until substantial product revenue is generated[208] Expenses and Cost Management - General and administrative expenses decreased by $1.4 million to $2.3 million for the three months ended June 30, 2025, compared to $3.7 million for the same period in 2024[189] - The total stock-based compensation expense for the six months ended June 30, 2025, was $941,523, a decrease from $1,673,325 in the same period of 2024[142] - Management plans to optimize expenditures and improve cash burn rate by reviewing the cost structure and seeking strategic collaborations and funding opportunities[50] - The primary use of cash is to fund operating expenses, including research and development and general administrative expenditures[206] Grants and Funding - The Company received a grant of $1.3 million from Eurostars and Innosuisse, with $0.45 million allocated to the Company, which was later terminated, resulting in a repayment of $0.21 million[98] - 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[99] - The Company recorded a reduction to research and development expenses of $0.3 million and $0.2 million for the three months ended June 30, 2025 and 2024, respectively, due to grants received[100] Risks and Uncertainties - The company faces risks common to early-stage biotechnology firms, including the need for significant additional research and development efforts prior to regulatory approval[38] - Increased costs may arise from global conditions such as high interest rates and supply chain disruptions, impacting overall funding requirements[210] - Management's estimates and judgments regarding financial conditions are based on historical experience and known trends, which may differ from actual results[209] Stock and Equity - The weighted average common stock for basic and diluted net loss per share increased from 19,215,582 in Q2 2024 to 30,341,523 in Q2 2025[16] - The company granted 1,204,325 stock options during the six months ended June 30, 2025, with a weighted average exercise price of $2.28[138] - The company had research commitments totaling $3.7 million as of June 30, 2025, for activities to be performed within one year[148] - As of June 30, 2025, the company had 4,903,778 outstanding warrants with a weighted average exercise price of $2.73[134] - The company’s stock options outstanding increased to 4,339,920 as of June 30, 2025, with a weighted average exercise price of $3.76[138]