Financial Performance - Total operating expenses for the three months ended September 30, 2025, were $15,809,125, compared to $2,301,172 for the same period in 2024 [157]. - The company has incurred losses and generated negative cash flows from operations since inception, with cash totaling $10.1 million as of September 30, 2025 [161]. - For the nine months ended September 30, 2025, net cash used in operations was $12.0 million, consisting of a net loss of $30.5 million [168]. - The company experienced a decrease in cash of $4.7 million for the nine months ended September 30, 2025, compared to a decrease of $1.3 million for the same period in 2024 [167]. Research and Development - Research and development expenses increased by $14.0 million and $18.3 million for the three and nine months ended September 30, 2025, respectively, compared to prior periods [158]. - The HALT-CINP-203 clinical trial is assessing Halneuron® in approximately 200 patients with moderate to severe neuropathic pain, with top-line data expected in the second half of 2026 [148]. - The company licensed the rights to the IV formulation of SP16 for the treatment of chemotherapy-induced peripheral neuropathy, with initial Phase 1 evaluation expected to start in the first half of 2026 [149]. - Halneuron® has been granted FDA fast-track review designation as a treatment for chemotherapy-induced neuropathic pain (CINP) [147]. Financing Activities - The company entered into a Loan Agreement for a total principal amount of $19.5 million, with $16.5 million disbursed on October 7, 2024 [150]. - A registered direct offering on March 12, 2025, resulted in gross proceeds of approximately $4.78 million from the sale of 578,950 shares at $8.26 per share [152]. - The company raised approximately $4.78 million through a registered direct offering of 578,950 shares of Common Stock on March 14, 2025 [163]. - Net cash provided by financing activities for the nine months ended September 30, 2025 was $7.3 million, attributed to loan proceeds and gross proceeds from the registered direct offering [170]. Equity and Debt Management - The company issued 191,017 shares of common stock and 89.5939 shares of Series A-2 Preferred Stock as part of a licensing agreement with Serpin Pharma [154]. - The company received $3 million in loan proceeds on February 18, 2025, with no debt outstanding as of September 30, 2025 due to a Debt Exchange and Cancellation Transaction [164]. - The company reclassified approximately $5.5 million from temporary equity to permanent equity due to waivers by holders of Series A Preferred Stock [174]. Going Concern - The company has substantial doubt regarding its ability to continue as a going concern within 12 months from the issuance of the Quarterly Report [166]. - The company will need to secure additional financing to fund ongoing clinical trials and operations beyond the first quarter of 2026 [166]. - There were no off-balance sheet arrangements as of September 30, 2025 [173]. Administrative Expenses - General and administrative expenses increased by $1.2 million for the nine months ended September 30, 2025, compared to the prior year period [160].
Virios Therapeutics(VIRI) - 2025 Q3 - Quarterly Report