MIRA

Study demonstrated Ketamir-2 was safe and well tolerated at all dose levels, with a favorable safety and tolerability profile, with no severe or clinically significant adverse effects observed. The drug showed rapid and predictable absorption, a favorable duration of action supporting once-daily dosing, and no CNS side effects typically seen with ketamine. MIAMI, FLORIDA / ACCESS Newswire / September 22, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced topline results from the single ascending dose (SAD) portion of its ongoing Phase 1 clinical trial evaluating the safety, tolerability, and pharmacokinetics (PK) of its lead oral candidate, Ketamir-2, in healthy volunteers. The randomized, placebo-controlled study enrolled 32 healthy adult participants across four escalating oral dose cohorts (50 mg to 600 mg). The primary endpoints were safety, tolerability, and PK characterization. Key Pharmacokinetic Findings Dose-proportional increases in exposure (Cmax and AUC) were observed across all dose levels tested. Median time to maximum plasma concentration (Tmax) reached within 1-2 hours, consistent across cohorts, confirming rapid and predictable absorption. Terminal half-life (t½) of Ketamir-2 ranged from 2-5 hours, while its primary active metabolite, nor-Ketamir, demonstrated a longer half-life of 6.5-8.5 hours. This favorable duration of action supports convenient once-daily dosing and may contribute to sustained therapeutic benefit. This contrasts with oral ketamine, which is characterized by erratic absorption and a much shorter half-life, limiting its clinical use in chronic treatment. The predictable PK profile of Ketamir-2 supports convenient once-daily dosing for patients with neuropathic pain and potentially other CNS conditions. Safety and Tolerability Ketamir-2 was generally safe and well tolerated across all four cohorts No dose-limiting toxicities or serious adverse events were observed Treatment-emergent adverse events were transient and resolved without intervention In addition to routine safety assessments, CNS effects were carefully monitored using validated tools (C-SSRS, Bowdle VAS, KSET). Across all SAD cohorts, Ketamir-2no clinically significant adverse effects obser...

Mira Pharmaceuticals (MIRA) said Friday that new preclinical results from obesity and nicotine addic

By Brad Sorensen, CFA NASDAQ:MIRA READ THE FULL MIRA RESEARCH REPORT MIRA Pharmaceuticals (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of a new molecular synthetic cannabinoid analog for the treatment of adult patients with neuropathic pain, as well as anxiety and cognitive decline typically associated with early-stage dementia. The company also acquired the rights to Ketamir, which, in layman’s terms, is a potential derivative of the antidepressant ketamine that has shown indications of having fewer side effects, working more rapidly, and having the opportunity to impact millions of patients that have not responded to other, existing treatments. We have written about the exciting preclinical results for Ketamir-2, the company’s novel oral ketamine analog, and the company just announced more positive testing results that build on all of the other positive results seen to this point and position Ketamir-2 to be a potential game-changing treatment. As if that’s not enough, company management continues to push forward and has signed a definitive agreement to acquire SKNY, which is developing SKNY-1 to help people lose weight and quit smoking by targeting biological pathways involved without triggering the central nervous system (CNS) side effects that have been associated with cannabinoid-based therapies. Recent in vitro preclinical data supports the therapeutic potential of SKNY-1. The study shows that SKNY-1 acts as a biased CB-1 inhibitor, which means it selectively blocks a signaling pathway associated with cravings and compulsive behavior. Additionally, this oral drug interacts with the CB2 receptor, which plays an important role in metabolic regulation and inflammation. Lastly, GLP-1 drugs, which are injected, have been the primary focus of weight loss drugs in recent history, but those have been associated with gastrointestinal side effects and muscle loss. In contrast, SKNY-1 is an oral drug with a mechanism that may help to preserve muscle mass and enhance patient adherence due to avoiding injection. Preliminary tests are very encouraging and have the potential to disrupt an obesity drug market that may pass $150 billion by 2030 and the stopping smoking market, which was valued at $28 billion in 2024—showing the massive potential as this drug moves through the testing process. We remain extre...

In this week’s “Psychedelic,” The Fly’s recurring series focused on psychedelic stock news, The Fly looks back on earnings, a patent grant and study results. Discover companies with rock-solid fundamentals in TipRanks' Smart Value Newsletter. Receive undervalued stocks, resilient to market uncertainty, delivered straight to your inbox. Q1 EARNINGS: On Thursday, Compass Pathways (CMPS) reported a first quarter loss per share of (24c), which compared to analyst estimates of a loss per share of (49c). The company said cash and cash equivalents were $260.1M as of March 31, compared with $165.1M as of December 31. Compass also guided to full year 2025 net cash used in operating activities in the range of $120M to $145M. The cash position at March 31 is expected to be sufficient to fund operating expenses and capital expenditure requirements at least through the planned 26-week data read-out from the COMP006 study, which is expected in the second half of 2026. “We eagerly await the upcoming topline 6-week data readout, on track for late June, the first data from our pivotal phase 3 COMP360 program in treatment resistant depression.” said Kabir Nath, CEO. “Our continued progress reinforces Compass’ leadership in psychedelic therapy development, which we believe represents the next generation of mental health therapeutic options and can lead to significant value creation.” GH Research (GHRS) also reported Q1 results Thursday with a loss per share of (19c), which compared to analyst consensus of a loss per share of (20c). Cash, cash equivalents, other financial assets and marketable securities were $315.3M as of March 31, compared to cash, cash equivalents, other financial assets and marketable securities of $182.6M as of December 31. Gross proceeds from public offering in Q1 were $150M. Additionally on Thursday, Mind Medicine (MNMD) reported a Q1 loss per share of (35c), which compared to analyst estimates of a loss per share of (37c). Cash, cash equivalents and investments totaled $245.5M as of March 31. The company believes that its cash, cash equivalents, and investments as of March 31 will be sufficient to fund the company’s operations into 2027. Based on the company’s current operating plan and anticipated R&D milestones, the company expects its cash runway to extend at least 12 months beyond its first Phase 3 topline data readout for MM120 ODT in General Anxie...

By Brad Sorensen, CFA NASDAQ:MIRA READ THE FULL MIRA RESEARCH REPORT MIRA Pharmaceuticals (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of a new molecular synthetic cannabinoid analog for the treatment of adult patients with neuropathic pain as well as anxiety and cognitive decline typically associated with early-stage dementia. The company also acquired the rights to Ketamir, which, in layman’s terms, is a potential derivative of the antidepressant ketamine that has shown indications of having fewer side effects, working more rapidly, and having the opportunity to impact millions of patients that have not responded to other, existing treatments. We have written about the exciting preclinical results for Ketamir-2, the company’s novel oral ketamine analog, and the company just announced more positive testing results that build on all of the other positive results seen to this point and position Ketamir-2 to be a potential game-changing treatment. Company management announced that a preclinical safety study required by the FDA showed that Ketamir-2 showed no evidence of brain toxicity. The company noted that this included the absence of Olney lesions, which are vacuolar brain changes historically associated with older NMDA-targeting drugs such as ketamine and MK-801. This announcement is crucial to the advancement of Ketamir-2 and sets the stage for human trials to continue. Ketamir-2 has a chance to be a game-changing treatment as it offers oral administration, with few known side effects, which is just as, or more, effective as existing treatments that require intravenous application and have major side effects. These study results should ease the FDA's concerns and allow human trials to continue. Management noted that the Phase I study on Ketamir-2 continues to advance and that the company plans to initiate a Phase IIa trial in diabetic neuropathy by year end. These recently released testing results expand the potential market opportunity for Ketamir-2 should, as we expect, the treatment gain FDA approval. We remain extremely positive on MIRA, and this announcement is yet further confirmation that company management is focused on bringing relief to as many patients as possible and providing value to shareholders. The company now has multiple potential groundbreaking therapies and is rightly focusi...

Ketamir-2 Demonstrates Strong Efficacy in Diabetic Neuropathy Model, with Some Subjects Achieving Complete Symptom Reversal MIAMI, FLORIDA / ACCESS Newswire / April 16, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA), or MIRA, a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic and neuropsychiatric disorders, today announced compelling data demonstrating the efficacy of the oral ketamine analog, Ketamir-2, in a validated animal model of diabetic neuropathy. In the study, Type 2 diabetes was induced in rats using a high-fat diet combined with a low dose of Streptozotocin (STZ). This resulted in hyperglycemia and neuropathic symptoms, including hyperalgesia and allodynia, mimicking human diabetic pathology. By week 8, most diabetic rats exhibited sensory hypersensitivity. Treatment with Ketamir-2 led to a significant reduction in neuropathic pain symptoms, with some animals returning completely to pre-diabetic baseline sensitivity. "Millions of patients with diabetic neuropathy are left with limited, often ineffective treatment options," said Erez Aminov, Chairman and CEO of MIRA. "With Ketamir-2, we're aiming to offer a non-opioid alternative that's not only safer but potentially more effective. We're currently advancing our Phase I study and plan to initiate a Phase IIa trial in diabetic neuropathy patients by year-end. Given that the FDA has designated neuropathic pain as a high-priority area for Fast Track and Breakthrough Therapy pathways, we believe Ketamir-2 is uniquely positioned to meet this urgent need and unlock significant clinical and commercial value." Translational Data Strengthens Clinical Momentum These results build upon prior preclinical studies using other neuropathy animal models, where orally administered Ketamir-2 outperformed FDA-approved neuropathic pain medications such as pregabalin and gabapentin, while also demonstrating a favorable safety profile. Unlike traditional ketamine, Ketamir-2 does not induce dissociative or psychedelic effects and is not a substrate for P-glycoprotein (P-gp), allowing for more efficient penetration across the blood-brain barrier. MIRA has already begun dosing and recruitment in its Phase I clinical trial at Hadassah Medical Center in Jerusalem. The study is progressing smoothly and on schedule. The randomized, double-blind, placebo-controlled trial is assessing...