Financial Performance - The company reported a net loss of approximately $3.47 million for the nine months ended September 30, 2025, compared to a net loss of $1.45 million for the same period in 2024, reflecting an increase in losses of $2.03 million [125]. - The company has incurred operating losses since inception and anticipates continued losses due to increased research and development costs for later-stage clinical trials [125]. - Net cash used in operating activities during the nine months ended September 30, 2025, was $1.38 million, primarily due to a net loss of $3.4 million [149]. - Other income increased by $169.05 thousand from $22.88 thousand for the nine months ended September 30, 2024, to $191.93 thousand for the same period in 2025, primarily due to vendor-related adjustments [143]. Expenses - General and administrative expenses increased by $2.2 million from $1.2 million for the nine months ended September 30, 2024, to $3.4 million for the same period in 2025, primarily due to legal and advisory service accruals related to the direct listing [141]. - The company expects to incur significant additional costs in research and development, general and administrative expenses, and marketing [148]. Cash Position - The company has cash and cash equivalents of approximately $3.11 million as of September 30, 2025, which is expected to fund operations into the first quarter of 2026 [126]. - Cash and cash equivalents available as of September 30, 2025, were approximately $3.1 million, which may not be sufficient to fund operations for the next 12 months [147]. - Net cash provided by financing activities during the nine months ended September 30, 2025, was $3.74 million, consisting entirely of proceeds from the issuance of common stock [152]. Clinical Trials and Research - The Phase 2-equivalent clinical trial for GX-03, targeting moderate to severe eczema, began in July 2025 with approximately 30% of enrollees having completed the trial as of now [128]. - The company is in discussions with multinational contract research organizations to initiate Phase 3-equivalent pivotal trials for GX-03 for the treatment of onychomycosis in 2026 [129]. - Research and development expenses for eczema and vaccine programs remained stable with no material change for the three and nine months ended September 30, 2025, compared to the same periods in 2024 [142]. - The company has completed preclinical studies for basal cell carcinoma, showing a 29% reduction in tumor size compared to placebo and a 20% reduction compared to standard care [124]. - The Hexagen formula demonstrated an 85% reduction in viral load in preclinical studies for herpes zoster ophthalmicus compared to placebo, indicating significant therapeutic potential [124]. Liabilities and Future Funding - As of September 30, 2025, total liabilities amounted to $3.79 million, including $2.3 million in current accounts payable and accrued expenses [145]. - The company anticipates requiring approximately $18.0 to $20.0 million for planned Phase 3 trials for eczema and onychomycosis, and $1.5 million to $2.5 million for its vaccine program [146]. - Deferred revenue as of September 30, 2025, was $1.44 million, primarily related to a license agreement for the FleX Product pending FDA approval [145]. - The company entered into a GEM Purchase Agreement allowing for the potential sale of up to $85.0 million in common stock under certain conditions [147]. Tax and Revenue - The company has federal cumulative NOL carryforwards of approximately $8.59 million and state NOL carryforwards of approximately $7.35 million as of December 31, 2024 [161]. - The company did not recognize any royalty revenue from licensing agreements to date [159].
Global Health Solutions(TTRX) - 2025 Q3 - Quarterly Report