MIRA Pharmaceuticals(MIRA) - 2025 Q3 - Quarterly Report

Financial Performance - MIRA Pharmaceuticals incurred $0.4 million in research and development expenses for Q3 2025, down from $1.0 million in Q3 2024, primarily due to decreased costs for the development of MIRA-55[100] - For the nine months ended September 30, 2025, research and development expenses totaled $1.2 million, a decrease from $2.4 million in the same period of 2024, again attributed to reduced costs for MIRA-55[101] - General and administrative expenses for Q3 2025 were $0.9 million, slightly down from $1.0 million in Q3 2024, mainly due to a decrease in stock-based compensation[103] - For the nine months ended September 30, 2025, general and administrative expenses increased to $3.4 million from $3.1 million in the same period of 2024, primarily due to increased stock-based compensation[104] - For the nine months ended September 30, 2025, operating activities used $3.5 million of cash, primarily driven by a net loss of $4.5 million[117] - Financing activities provided $3.4 million of cash, resulting from $3.0 million proceeds from the sale of common stock and $0.29 million from stock option exercises[119] - The cash used in operating activities was offset by $1.8 million in stock-based compensation expense for the nine months ended September 30, 2025[117] - For the nine months ended September 30, 2024, operating activities used $3.7 million of cash, primarily driven by a net loss of $5.4 million[118] Acquisition and Investments - MIRA Pharmaceuticals acquired SKNY Pharmaceuticals on September 29, 2025, with SKNY becoming a wholly owned subsidiary, enhancing MIRA's portfolio with the preclinical drug candidate SKNY-1[93] - The acquisition of SKNY included 3,521,127 shares of Telomir Pharmaceuticals, valued at $4,718,310 at the time of acquisition, which increased to $4,894,366 by September 30, 2025, resulting in an unrealized gain of $176,056[106] - The company recorded a value of $4,718,310 for 3,521,127 shares of common stock in Telomir Pharmaceuticals, Inc. acquired from SKNY[122] Regulatory and Clinical Developments - The FDA cleared the Investigational New Drug application for Ketamir-2 on July 29, 2025, allowing MIRA to initiate U.S.-based clinical trials for neuropathic pain[97] - MIRA plans to begin a Phase 2a study for Ketamir-2 in chemotherapy-induced peripheral neuropathy in the first half of 2026, pending regulatory feedback[90] Financial Outlook and Compliance - MIRA expects to fund operations through the third quarter of 2026 but will require additional financing to support ongoing clinical development activities[109] - The company has raised $6.7 million through an ATM financing supported by a shelf registration statement filed with the SEC[110] - As of September 30, 2025, the company's shareholder's equity was $7.6 million, and it had sold 4,133,402 shares in ATM transactions with net proceeds of $6.7 million[123] - On April 8, 2025, the company received a notification from Nasdaq indicating non-compliance with the minimum stockholders' equity requirement of $2.5 million[120] - Nasdaq accepted the company's compliance plan on May 7, 2025, granting an extension until October 6, 2025, to regain compliance[121] - The company has no material non-cancellable contractual obligations as of September 30, 2025[114] - The management concluded that the disclosure controls and procedures were effective as of September 30, 2025[129]