Gain Therapeutics(US:GANX)2025-11-12 21:09Financial Performance - Net loss for the three months ended September 30, 2025, was $5,284,373, compared to a net loss of $4,485,692 for the same period in 2024, indicating an increase in loss of approximately 17.8%[16] - For the nine months ended September 30, 2024, the net loss was $16,642,964, compared to a net loss of $15,623,518 for the same period in 2025, indicating a decrease in losses year-over-year[31] - The company incurred net losses of $5.3 million and $15.6 million for the three and nine months ended September 30, 2025, respectively, with negative cash flows from operations of $13.8 million during the nine months[186] - The company has not generated any revenue from product sales and has incurred significant operating losses and negative cash flows from operations[212] - The company has not yet received approval for or commercialized any products or technologies, and does not expect to generate revenue from sales in the near term[212] Assets and Liabilities - Total current assets decreased from $11,602,478 as of December 31, 2024, to $10,517,268 as of September 30, 2025, a decline of approximately 9.36%[13] - Total liabilities increased from $4,784,310 as of December 31, 2024, to $5,062,250 as of September 30, 2025, representing an increase of about 5.8%[13] - Total stockholders' equity decreased from $7,339,574 as of December 31, 2024, to $5,909,430 as of September 30, 2025, a decline of approximately 19.4%[13] - Cash and cash equivalents decreased from $10,385,863 as of December 31, 2024, to $8,807,353 as of September 30, 2025, a reduction of about 15.2%[13] - As of September 30, 2025, the Company has cash and cash equivalents of $8.8 million, which is insufficient to fund estimated operating and capital expenditures for at least the next 12 months[50] Research and Development - Research and development expenses for the nine months ended September 30, 2025, were $7,865,493, down from $9,566,259 for the same period in 2024, a decrease of about 17.8%[16] - Research and development expenses for the three months ended September 30, 2025, increased to $2.8 million, a rise of $0.2 million compared to the same period in 2024, primarily due to ongoing clinical trials[203] - For the nine months ended September 30, 2025, research and development expenses decreased to $7.9 million, down $1.7 million from $9.6 million in the same period in 2024, attributed to research grant income and tax credits[204] - The company’s clinical stage product candidate, GT-02287, is being developed for the treatment of Parkinson's disease, with positive early results from a Phase 1b clinical study presented in October 2025[36] - The Phase 1b clinical study of GT-02287 showed that participants experienced stabilization and trending improvements in their MDS-UPDRS scores after 90 days of administration[36] Capital and Financing - The company has primarily funded its operations through equity financings and research grants, indicating reliance on external capital for continued operations[47] - The company reported net proceeds from the issuance of shares in ATM offerings of $615,515 for the nine months ended September 30, 2024, and $4,910,240 for the same period in 2025, showing a significant increase in capital raised[31] - The Company completed a public offering in July 2025, raising gross proceeds of $7.0 million, with net proceeds of $6.0 million after offering expenses[137] - The company raised gross proceeds of $11.5 million from a public offering in June 2024, which included $1.2 million in underwriting commissions and expenses[147] - The company plans to finance its cash needs through public and private equity offerings, debt financings, and collaborations, but may face challenges in obtaining favorable terms[187] Operational Challenges - The Company has significant doubt about its ability to continue as a going concern due to current liquidity issues and lack of expected revenues[50] - The company has not generated any product revenues and does not expect to do so in the foreseeable future[190] - The company anticipates needing to raise additional capital to fund operations beyond the first quarter of 2026 due to projected cash outflows[186] - Management is reviewing the cost structure to optimize expenditures and improve the overall cash burn rate, including research and development expenses[51] Tax and Income - Income taxes increased to $549 thousand for the three months ended September 30, 2025, compared to $11 thousand for the same period in 2024, primarily due to higher corporate taxes in Australia[92] - Income taxes were $791 thousand for the nine months ended September 30, 2025, compared to $32 thousand in the same period of 2024[211] Currency and Foreign Exchange - The company experienced a foreign exchange loss of $26,170 for the three months ended September 30, 2025, compared to a gain of $229,047 for the same period in 2024[20] - Accumulated currency translation adjustments as of September 30, 2025, amounted to $835,949, compared to $41,247 as of December 31, 2024[57] - The Company has not utilized any foreign currency hedging strategies, exposing it to foreign currency risk[57] Stock and Compensation - The total stock-based compensation expense for the nine months ended September 30, 2025, was $1.4 million, compared to $2.0 million for the same period in 2024[158] - The Company issued 1,204,325 stock options during the nine months ended September 30, 2025, with a weighted average exercise price of $2.28[154] - The weighted average grant date fair value of stock options granted in the nine months ended September 30, 2025, was $1.63[156] - As of September 30, 2025, unrecognized compensation costs associated with stock options grants were $3.5 million, expected to be recognized over 3.5 years[154] Legal and Compliance - The Company recorded an accrual of $0.53 million related to litigation against the former CEO, which was dismissed on July 2, 2025[165]