Advancing a selective oral NMDA receptor modulator toward Phase 2a in chemotherapy-induced peripheral neuropathy following favorable Phase 1 safety and tolerability findings MIAMI, FLORIDA / ACCESS Newswire / March 4, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral therapeutics for neuropathic and inflammation-driven pain conditions, metabolic disorders, and oncology-related indications, today announced completion of do ...

Core Insights - MIRA Pharmaceuticals has initiated dosing in the final cohort of its Phase 1 clinical trial for Ketamir-2, an oral NMDA receptor antagonist, with plans to complete the trial by the end of Q1 2026 [1] - The company is preparing for a Phase 2a study targeting chemotherapy-induced peripheral neuropathy (CIPN) and aims to submit the protocol to the FDA after completing Phase 1 [1] - MIRA plans to pursue FDA Fast Track designation for Ketamir-2 due to the significant unmet medical need in CIPN treatment [1] Phase 1 Progress and Phase 2a Development Plans - The ongoing Phase 1 study is randomized, double-blind, and placebo-controlled, focusing on safety, tolerability, and pharmacokinetics of Ketamir-2 [1] - So far, 50 healthy volunteers have been dosed, with 6 subjects remaining in the final cohort [1] - No serious adverse events have been reported, supporting the advancement of the program [1] - The Phase 2a study is expected to begin in Q2 2026, pending regulatory feedback [1] Unmet Medical Need in CIPN - CIPN is a common complication of cancer treatment, leading to chronic nerve pain and significantly impairing quality of life [1] - There are currently no FDA-approved treatments for CIPN, with management relying on off-label therapies that often provide limited benefits [1] - Ketamir-2 aims to offer a safer, orally administered alternative without the psychoactive effects associated with existing treatments [1] Strategic Partnering and Scientific Engagement - MIRA will attend the BIO Partnering Investment & Growth Summit in March 2026 to engage with pharmaceutical companies for potential partnerships [1] - The company will present Phase 1 data on Ketamir-2 at the AACR Annual Meeting in April 2026 [1] Pipeline Update Beyond Ketamir-2 - MIRA is also developing two preclinical programs, SKNY-1 and MIRA-55, both undergoing CMC optimization [1] - SKNY-1 targets weight loss and nicotine addiction, designed to avoid CNS-related adverse effects [1] - MIRA-55 has shown analgesic activity comparable to morphine and significant anti-inflammatory effects in preclinical models [1]

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]

Core Insights - MIRA Pharmaceuticals, Inc. has initiated the multiple ascending dose (MAD) portion of its Phase 1 clinical trial for its lead oral candidate, Ketamir-2, targeting chemotherapy-induced peripheral neuropathy (CIPN) as the lead indication for Phase 2a evaluation [1] Company Developments - The company is focused on developing novel oral therapeutics for neurologic, neuropsychiatric, and metabolic disorders [1] - The Phase 1 clinical trial is currently evaluating Ketamir-2 in healthy volunteers [1] - CIPN is identified as a common and debilitating side effect of cancer treatment, highlighting the potential market need for effective therapies [1]

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential trading opportunities before the market opens [1] Premarket Gainers - rYojbaba Co., Ltd. (RYOJ) increased by 134% to $5.09 - Linkage Global Inc (LGCB) rose by 101% to $3.33 - MIRA Pharmaceuticals, Inc. (MIRA) gained 87% to $2.46 - Auddia Inc. (AUUD) went up by 23% to $2.54 - SOPHiA GENETICS SA (SOPH) increased by 16% to $4.99 - J.B. Hunt Transport Services, Inc. (JBHT) rose by 13% to $157.44 - AlphaVest Acquisition Corp (ATMV) increased by 11% to $13.09 - New Era Energy & Digital, Inc. (NUAI) went up by 10% to $3.71 - Critical Metals Corp. (CRML) rose by 9% to $24.80 - Blaize Holdings, Inc. (BZAI) increased by 9% to $6.90 [3] Premarket Losers - Fossil Group, Inc. (FOSL) decreased by 40% to $2.23 - Pinnacle Food Group Limited (PFAI) fell by 25% to $3.41 - American Battery Technology Company (ABAT) declined by 22% to $6.91 - Sadot Group Inc. (SDOT) dropped by 20% to $6.15 - TechCreate Group Ltd. (TCGL) decreased by 14% to $4.14 - PMGC Holdings Inc. (ELAB) fell by 13% to $6.43 - Arcadia Biosciences, Inc. (RKDA) decreased by 13% to $4.73 - ATIF Holdings Limited (ZBAI) dropped by 11% to $9.28 - Roma Green Finance Limited (ROMA) fell by 7% to $2.62 - Australian Oilseeds Holdings Limited (COOT) decreased by 6% to $2.46 [4]

Core Insights - MIRA Pharmaceuticals has demonstrated that oral Mira-55 fully normalizes pain and significantly reduces inflammation, which supports its Investigational New Drug (IND) plans [1] - The findings reinforce MIRA's competitive position in the $70 billion non-opioid pain market [1] Company Summary - MIRA Pharmaceuticals, Inc. is focused on developing non-opioid pain management solutions, with recent findings highlighting the efficacy of its product, Mira-55 [1] - The company is advancing its plans for regulatory approval, indicating a strategic move towards commercialization in a lucrative market [1] Industry Summary - The non-opioid pain management market is valued at $70 billion, presenting significant opportunities for companies like MIRA Pharmaceuticals that are innovating in this space [1] - The shift towards non-opioid solutions is driven by the need for safer pain management alternatives, highlighting the relevance of MIRA's developments [1]

Core Viewpoint - MIRA Pharmaceuticals has successfully completed the acquisition of SKNY Pharmaceuticals, enhancing its financial position and supporting its ongoing development programs [1] Financial Position - The acquisition included a contribution of $5 million in marketable securities from SKNY, which strengthens MIRA's balance sheet [1] Development Programs - The acquisition complements MIRA's advancing programs, specifically Ketamir-2 and MIRA-55, which focus on neurologic, neuropsychiatric, and metabolic disorders [1]

Core Insights - The study demonstrated that Ketamir-2 is safe and well tolerated at all dose levels, with no severe or clinically significant adverse effects observed [1] - The drug exhibited rapid and predictable absorption, supporting a favorable duration of action for once-daily dosing [1] - Ketamir-2 does not present CNS side effects typically associated with ketamine [1]

Core Viewpoint - MIRA Pharmaceuticals, Inc. has announced positive results for its oral drug candidate Ketamir-2, which has shown efficacy in restoring normalized behavior in stressed animals within a validated model of post-traumatic stress disorder (PTSD) [1] Group 1: Drug Development - Ketamir-2 is currently undergoing evaluation in an ongoing Phase 1 clinical trial specifically for neuropathic pain, where it has demonstrated a favorable safety profile to date [1] - The company is broadening the development of Ketamir-2 into neuropsychiatric disorders, including PTSD, indicating a strategic expansion of its therapeutic applications [1] Group 2: Company Overview - MIRA Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company focused on developing novel oral therapeutics for neurologic, neuropsychiatric, and metabolic disorders [1]

Core Insights - MIRA Pharmaceuticals has strengthened its pipeline with the acquisition of SKNY Pharmaceuticals, focusing on a differentiated oral candidate, SKNY-1, which has shown up to 30% weight loss and reversal of nicotine cravings in preclinical studies [1] Company Developments - MIRA Pharmaceuticals, a clinical-stage pharmaceutical company, specializes in developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders [1] - The acquisition of SKNY Pharmaceuticals was approved by MIRA's stockholders during the 2025 Annual Meeting [1]