Clinical Development - Full enrollment of the Phase 1b study for GT-02287 in Parkinson's disease was reached with 16 participants, with total enrollment not expected to exceed 20 participants [2] - Analysis of functional changes and biomarker activity from the Phase 1b study is expected to be available in Q4 2025 [14] - Approval from healthcare authorities in Australia to extend the dosing duration for participants in the Phase 1b study beyond the original 90 days [14] - The company plans to submit an Investigational New Drug (IND) application to the FDA by the end of 2025 to facilitate expansion of Phase 2 clinical development for GT-02287 in the U.S. [14] - Compelling preclinical data suggest that GT-02287 may have the potential to slow or stop the progression of Parkinson's disease [10] Financial Performance - Net loss for Q2 2025 was $0.19 per share, compared to $0.42 per share for Q2 2024 [8] - The company reported a loss of $10,339,145 for the period, compared to a loss of $20,411,191 in the previous period, indicating an improvement of about 49.3% [22] Expenses - Research and Development (R&D) expenses decreased by $1.7 million to $2.8 million for Q2 2025, compared to $4.4 million for Q2 2024, primarily due to research grant income and optimization of pipeline costs [6] - General and Administrative (G&A) expenses decreased by $1.4 million to $2.3 million for Q2 2025, compared to $3.7 million for Q2 2024, mainly due to a reduction in stock-based compensation [7] Cash and Assets - Cash and cash equivalents were $6.7 million as of June 30, 2025, down from $10.4 million as of December 31, 2024 [8] - Cash and cash equivalents decreased from $10,385,863 to $6,694,136, a reduction of approximately 35.0% [22] - Total assets decreased from $12,123,884 to $9,833,980, a decline of approximately 19.0% [22] Liabilities and Equity - Current liabilities increased significantly from $3,911,321 to $5,197,044, representing a rise of about 32.9% [22] - Total stockholders' equity dropped from $7,339,574 to $3,696,050, a decrease of approximately 49.7% [22] - Additional paid-in capital increased from $88,779,318 to $94,642,942, reflecting a growth of about 6.5% [22] - The defined benefit pension plan liability rose from $443,623 to $522,676, an increase of approximately 17.8% [22] - Total noncurrent liabilities increased from $872,989 to $940,886, a rise of about 7.8% [22] - Accumulated deficit worsened from $(60,783,717) to $(81,194,908), indicating a decline of approximately 33.6% [22] Funding - Gain completed an underwritten public offering resulting in approximately $7.1 million of net proceeds, extending the cash runway beyond the completion of the Phase 1b study [14] Shareholder Information - The number of common shares issued and outstanding increased from 27,132,588 to 30,771,321, representing a growth of about 13.3% [22]
Gain Therapeutics(GANX) - 2025 Q2 - Quarterly Results