MIRA

Obesity Treatment Candidate Designed to Preserve Lean Body Mass Toxicokinetic Findings De-Risk Dose Selection and Support Regulatory Pathway Toward IND See what 10M+ investors are talking about. Get the Stocktwits Daily Rip for what retail is watching right now, free to your inbox MIAMI, Aug. 06, 2026 (GLOBE NEWSWIRE) -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company developing novel oral small-molecule therapeutics, today announced positive toxicokinetic findings from a 7-day repeated-dose study of SKNY-1 in Beagle dogs. The study demonstrates dose-dependent systemic exposure and rapid absorption that de-risk dose selection and support advancement toward GLP toxicology studies and IND-enabling development. The study evaluated SKNY-1 following repeated daily oral dosing in male and female Beagle dogs over 7 days. SKNY-1 demonstrated rapid oral absorption and dose-dependent systemic exposure across the evaluated dose range. Plasma concentrations were comparable between male and female animals. The data demonstrates evidence of dose-dependent response and systemic accumulation with repeated dosing, providing confidence in dose selection for the planned GLP toxicology program. "Obesity treatments today often come at the cost of lean muscle loss, which undermines long-term health outcomes," said Erez Aminov, Chairman and Chief Executive Officer of MIRA Pharmaceuticals. "SKNY-1 aims to solve that problem. These toxicokinetic findings de-risk our dose selection, and we're excited to continue advancing SKNY-1 toward IND-enabling development." Dr. Itzchak Angel, Chief Scientific Advisor of MIRA, added: "Characterizing systemic exposure in a larger animal species is essential for translating to humans. The dose-dependent relationship and rapid absorption in dogs further strengthen our development package and support advancement toward GLP toxicology studies." These toxicokinetic findings will inform dose selection and study design for the Company's planned GLP-compliant toxicology program. MIRA is advancing SKNY-1 through additional preclinical efficacy and safety studies to build a comprehensive nonclinical package supporting IND-enabling development for obesity. About SKNY-1 In peer-reviewed preclinical studies published in the International Journal of Molecular Sciences, oral SKNY-1 demonstrated dose-dependent reductions in body weight while preserving lean body mass, along with lipid normalization and reduced hepatic triglyceride accumulation. The compound attenuated compulsive feeding behavior in validated experimental models. In separate behavioral studies, SKNY-1 was devoid of anxiety-related effects despite engaging central cannabinoid pathways, distinguishing it from earlier CB1-targeting therapies. A lead oral formulation demonstrated favorable bioavailability with robust brain penetration and substantial liver exposure, supporting once-daily oral dosing potential. About MIRA Pharmaceuticals, Inc. MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) is a clinical-stage pharmaceutical company developing novel oral small-molecule therapeutics. The Company's pipeline includes Ketamir-2 for chemotherapy-induced peripheral neuropathy (CIPN), which has completed Phase 1 and is advancing toward Phase 2a under an active IND; MIRA-55, an investigational oral drug candidate for chronic inflammatory pain; and SKNY-1, an investigational oral drug candidate for obesity. Following scientific review, the U.S. Drug Enforcement Administration has determined that Ketamir-2, MIRA-55 and SKNY-1 are not classified as controlled substances. Cautionary Note Regarding Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally may be identified by the use of words such as "anticipate," "expect," "plan," "can," "could," "would," "may," "will," "believe," "estimate," "forecast," "goal," "project," "guidance," "potential," "intend," "seek," "target" and other words of similar meaning, although not all forward-looking statements include these words. Forward-looking statements may include, but are not limited to, statements regarding the therapeutic potential, mechanism of action, development plans, regulatory pathway, safety profile, efficacy, anticipated clinical development, commercialization prospects, market opportunity, and future development of MIRA-55, SKNY-1, Ketamir-2, and the Company's other product candidates. These forward-looking statements are based on current expectations, estimates, forecasts, and projections, as well as management's current beliefs and assumptions, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, risks related to preclinical and clinical development, the ability to obtain regulatory approvals, the outcome of future studies, reliance on third parties, intellectual property protection, financing needs, market conditions, and the other risks identified under the heading "Risk Factors" contained in the Company's Annual Report on Form 10-K and the Company's subsequent filings with the U.S. Securities and Exchange Commission (“SEC”). Forward-looking statements contained in this press release speak only as of the date of this press release, and the Company undertakes no obligation to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by applicable law. Investors are cautioned not to place undue reliance on these forward-looking statements. Additional information regarding these and other risks and uncertainties is contained in the Company's filings with the SEC, including its Annual Report on Form 10-K and subsequent filings, available at www.sec.gov and in the Investors section of the Company's website at www.mirapharmaceuticals.com. Forward-looking statements should be considered in light of these risks and uncertainties. Contact: Krystina QuintanaMIRA [email protected] (786) 432-9792 Note: This article has been published automatically by sourcing from Access Newswire. The Stocktwits editorial team did not edit this article. Stocktwits PR Desk has no position in any of the stocks mentioned in this article. StockTwits' news team content is for informational purposes only and is not intended as investment advice. For more, see our editorial policy. This article was originally published on StockTwits. Related: Why S&P 500, Dow Futures Are Slipping Overnight After Wall Street’s Second Straight Day In The Red TTD Stock Crashes Overnight: CEO Says Trade Desk's Customers ‘Operating In Different Environment' DKNG Stock Slips After-Hours As Q2 Earnings Disappoint — CEO Says Predictions Growing Faster Than Expected, Ready To Win NFL Season

Optimized Oral Formulation Demonstrates Favorable Oral Bioavailability Together with Robust Brain and Liver Distribution Following Oral Administration MIAMI, FL / ACCESS Newswire / July 10, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company, today announced positive results from preclinical studies evaluating optimized oral formulations of MIRA-55, the Company's oral drug candidate being developed as a non-opioid therapy for chronic inflammatory pain. Following evaluation of multiple oral formulations, the Company selected a lead formulation demonstrating favorable oral bioavailability together with sustained systemic exposure and reproducible distribution into both brain and liver tissue following oral administration. Collectively, these findings support the continued development of MIRA-55 as an orally administered therapy for chronic inflammatory pain. "Patients deserve safer and more effective non-opioid treatment options for chronic inflammatory pain," said Erez Aminov, Chief Executive Officer of MIRA Pharmaceuticals. "These formulation and pharmacokinetic findings represent another important step in advancing MIRA-55 as a differentiated oral therapy designed to address that need." The objective of the study was to optimize the oral formulation of MIRA-55 by comparing multiple formulations in a preclinical pharmacokinetic study. An intravenous reference arm was included to characterize absolute oral bioavailability and support selection of the lead formulation based on its overall pharmacokinetic profile. The selected formulation demonstrated reproducible distribution into both brain and liver tissue following oral administration. Brain exposure may support modulation of central pain-processing pathways, while peripheral distribution may contribute to the anti-inflammatory activity previously observed in MIRA's preclinical efficacy studies. Together, these findings demonstrate that the optimized formulation successfully delivers MIRA-55 to pharmacologically relevant tissues associated with both central and peripheral mechanisms of chronic inflammatory pain. "Formulation optimization is far more than a pharmaceutical exercise-it is what enables a molecule to consistently engage its intended biological targets," said Itzchak Angel, Ph.D., Chief Scientific Advisor of MIRA Pharmaceuticals. "The combination of favorable oral exposure together with reproducible brain and peripheral tissue distribution provides important support for MIRA-55's proposed mechanism of action and its continued development as an oral therapy for chronic inflammatory pain." Today's pharmacokinetic findings build upon MIRA's previously reported preclinical studies demonstrating that oral MIRA-55 normalized pain and reduced inflammation in a validated inflammatory pain model, outperforming injected morphine, while also exhibiting a differentiated pharmacological profile relative to THC. In separate mechanistic and behavioral studies, MIRA-55 demonstrated anxiolytic activity, did not produce the characteristic central nervous system effects associated with THC, and was shown to interact with the cannabinoid system through a mechanism distinct from THC. Collectively, these efficacy, behavioral, mechanistic, and pharmacokinetic findings continue to strengthen the overall development package supporting MIRA-55 as a differentiated oral therapeutic candidate for chronic inflammatory pain. The Company plans to continue evaluating the relationship between tissue exposure, pharmacodynamic activity, and therapeutic efficacy as MIRA-55 advances through additional preclinical development. About Mira-55 Mira-55 is a next-generation cannabinoid analog designed to modulate cannabinoid receptor activity, including CB1 and CB2 pathways, while minimizing CB1-related psychoactivity. Following scientific review, the U.S. Drug Enforcement Administration (DEA) determined that Mira-55 is not classified as a controlled substance. About MIRA Pharmaceuticals, Inc. MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company developing novel oral small-molecule therapeutics for neurologic, inflammatory, metabolic, and neuropsychiatric disorders. The Company's pipeline includes Ketamir-2, an investigational oral therapy that successfully completed a Phase 1 clinical trial and for which the Company has submitted a Phase 2a protocol to the U.S. Food and Drug Administration (FDA) under its active U.S. Investigational New Drug (IND) application for chemotherapy-induced peripheral neuropathy (CIPN); MIRA-55, a preclinical oral drug candidate being developed for chronic inflammatory pain; and SKNY-1, a preclinical oral drug candidate being developed for obesity and addiction-related disorders. Cautionary Note Regarding Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as "anticipate," "expect," "plan," "can," "could," "would," "may," "will," "believe," "estimate," "forecast," "goal," "project," "guidance," "potential," "intend," "seek," "target" and other words of similar meaning, although not all forward-looking statements include these words. Forward-looking statements may include, but are not limited to, statements regarding the development of SKNY-1; its potential efficacy, safety, tolerability, pharmacokinetic profile, tissue distribution, mechanism of action, and therapeutic benefits; the potential advantages of SKNY-1 compared to existing treatment options; the potential for once-daily oral dosing; the preservation of lean body mass; future preclinical studies; future clinical development; regulatory interactions; intellectual property protection; strategic partnership opportunities; and the future development and commercialization of SKNY-1. Forward-looking statements are based on current expectations, estimates, forecasts, and projections, as well as management's beliefs and assumptions, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, risks related to preclinical and clinical development; the ability to obtain regulatory approvals; the outcome of future studies; reliance on third parties; intellectual property protection; financing needs; market conditions; and the other risks identified under the heading "Risk Factors" contained in the Company's Annual Report on Form 10-K and the Company's other filings with the U.S. Securities and Exchange Commission ("SEC"). Forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update or revise such statements, whether as a result of new information, future events, or otherwise, except as required by applicable law. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. Investors are encouraged to review the Company's filings with the SEC, available at www.sec.gov, and in the Investors section of the Company's website at www.mirapharma.com, for a discussion of these and other risks and uncertainties. ContactKrystina QuintanaMIRA Pharmaceuticals, [email protected](786) 432-9792 SOURCE: MIRA Pharmaceuticals View the original press release on ACCESS Newswire

New Preclinical Data Demonstrate Favorable Oral Bioavailability, Robust Brain Penetration and Liver Exposure with Once-Daily Dosing Potential MIAMI, FL / ACCESS Newswire / July 6, 2026 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company, today announced positive results from preclinical studies evaluating the optimized oral formulation of SKNY-1, the Company's oral drug candidate being developed for obesity and addiction-related disorders. The studies demonstrated favorable oral bioavailability together with reproducible systemic exposure and robust brain penetration, and substantial liver exposure following oral administration. Peak plasma concentrations were observed approximately six to twelve hours after dosing, supporting the potential for convenient once-daily oral dosing. Collectively, these findings further strengthen the development profile of SKNY-1 by demonstrating that the compound combines meaningful pharmacologic activity observed in previously reported efficacy studies with pharmacokinetic characteristics that support continued development as an orally administered therapeutic. "We believe the next generation of obesity therapies should not only help patients lose weight, but also preserve lean body mass, support long-term metabolic health, and provide the convenience of oral administration," said Erez Aminov, CEO of MIRA."These formulation and pharmacokinetic findings further strengthen our confidence in SKNY-1 as a differentiated oral drug candidate designed to address both obesity and addiction through a novel mechanism." The objective of the study was to optimize the oral formulation of SKNY-1 and evaluate its pharmacokinetic profile, oral bioavailability, and tissue distribution following oral administration. Multiple oral formulations were evaluated in a preclinical pharmacokinetic study to identify an optimized formulation that provides reproducible systemic exposure together with meaningful distribution into pharmacologically relevant target tissues. Importantly, SKNY-1 demonstrated robust brain penetration and substantial liver exposure following oral administration. Detectable tissue exposure was consistently observed across multiple animals, supporting reliable and reproducible distribution into target organs. The simultaneous exposure of both the central nervous system and liver is particularly significant because these organs regulate complementary aspects of appetite, reward signaling, and metabolic homeostasis. Brain penetration may support modulation of neuronal circuits involved in appetite, satiety, and reward-associated behaviors, while liver exposure may contribute to regulation of lipid metabolism, glucose homeostasis, and energy utilization previously observed in preclinical efficacy studies. Importantly, robust brain penetration was achieved while maintaining a differentiated central nervous system profile. As previously reported by the Company, SKNY-1 was devoid of anxiety-related behavior in a validated preclinical cannabinoid behavioral model despite engaging central cannabinoid pathways. These findings distinguish SKNY-1 from earlier CB1-targeting therapies, including rimonabant, which were associated with significant neuropsychiatric adverse effects. SKNY-1 was designed with a differentiated pharmacological profile combining biased CB1 receptor modulation, partial CB2 receptor agonism, and selective MAO-B inhibition without MAO-A inhibition. The Company believes this differentiated pharmacology may allow engagement of central pathways involved in appetite regulation and reward signaling while potentially avoiding the psychiatric limitations that restricted earlier CB1-targeting therapies. "Earlier CB1-targeting therapies demonstrated the importance of the pathway, but their development was ultimately limited by neuropsychiatric side effects," said Itzchak Angel, Ph.D., CSA of MIRA. "The combination of robust brain penetration together with our previously reported behavioral findings reinforces the differentiated pharmacological profile of SKNY-1 and supports its continued development as a potential next-generation therapy targeting the endocannabinoid system." The pharmacokinetic findings complement MIRA's recently published peer-reviewed preclinical studies demonstrating that SKNY-1 produced significant reductions in body weight, preserved lean body mass, improved lipid parameters, reduced hepatic triglyceride accumulation, and attenuated compulsive feeding and nicotine-seeking behaviors in validated experimental models of obesity. Taken together, the efficacy, behavioral, mechanistic, and pharmacokinetic findings continue to strengthen the overall development package supporting SKNY-1 as a differentiated oral therapeutic candidate. Key Study Highlights Optimized oral formulation demonstrated favorable oral bioavailability following oral administration. Pharmacokinetic profile supports the potential for convenient once-daily oral dosing. Robust brain penetration and substantial liver exposure following oral administration. Reproducible systemic exposure and target tissue distribution across multiple animals. Findings complement previously reported efficacy, behavioral, mechanistic, and pharmacokinetic studies supporting SKNY-1's differentiated development profile. The Company plans to continue evaluating the relationship between tissue exposure, pharmacodynamic activity, and therapeutic efficacy as SKNY-1 advances through additional preclinical development. About SKNY-1 SKNY-1 is an orally administered investigational drug candidate designed to modulate multiple pathways associated with metabolic regulation and reward-associated behaviors. The compound was designed to combine pathway-selective CB1 modulation, CB2 receptor activity, and selective MAO-B inhibition. In preclinical studies, oral administration of SKNY-1 was associated with dose-dependent reductions in body weight and lipid normalization, with no significant reduction in whole-body density observed during the treatment period - a finding relevant in the context of ongoing clinical focus on lean body mass preservation during weight reduction. SKNY-1 has not been approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority, and its safety and efficacy have not been established in humans. About MIRA Pharmaceuticals, Inc. MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company developing novel oral small-molecule therapeutics for serious neurologic, inflammatory, metabolic, and neuropsychiatric disorders. The Company's pipeline includes Ketamir-2, an investigational oral therapy that successfully completed a Phase 1 clinical trial and for which the Company has submitted a Phase 2a protocol to the U.S. Food and Drug Administration (FDA) under its active U.S. Investigational New Drug (IND) application for chemotherapy-induced peripheral neuropathy (CIPN); MIRA-55, a preclinical therapy being developed for chronic inflammatory pain; and SKNY-1, a preclinical oral small-molecule drug candidate being developed for obesity and addiction-related disorders. Cautionary Note Regarding Forward-Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as "anticipate," "expect," "plan," "can," "could," "would," "may," "will," "believe," "estimate," "forecast," "goal," "project," "guidance," "potential," "intend," "seek," "target" and other words of similar meaning, although not all forward-looking statements include these words. Forward-looking statements may include, but are not limited to, statements regarding the development of SKNY-1; its potential efficacy, safety, tolerability, pharmacokinetic profile, tissue distribution, mechanism of action, and therapeutic benefits; the potential advantages of SKNY-1 compared to existing treatment options; the potential for once-daily oral dosing; the preservation of lean body mass; future preclinical studies; future clinical development; regulatory interactions; intellectual property protection; strategic partnership opportunities; and the future development and commercialization of SKNY-1. Forward-looking statements are based on current expectations, estimates, forecasts, and projections, as well as management's beliefs and assumptions, and are subject to significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, risks related to preclinical and clinical development; the ability to obtain regulatory approvals; the outcome of future studies; reliance on third parties; intellectual property protection; financing needs; market conditions; and the other risks identified under the heading "Risk Factors" contained in the Company's Annual Report on Form 10-K and the Company's other filings with the U.S. Securities and Exchange Commission ("SEC"). Forward-looking statements contained in this press release speak only as of the date hereof, and the Company undertakes no obligation to update or revise such statements, whether as a result of new information, future events, or otherwise, except as required by applicable law. We caution investors not to place undue reliance on the forward-looking statements contained in this press release. Investors are encouraged to review the Company's filings with the SEC, available at www.sec.gov, and in the Investors section of the Company's website at www.mirapharma.com, for a discussion of these and other risks and uncertainties. ContactKrystina QuintanaMIRA Pharmaceuticals, [email protected](786) 432-9792 SOURCE: MIRA Pharmaceuticals View the original press release on ACCESS Newswire

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 observed. Next Steps Based on the data, MIRA is initiating the multiple ascending dose (MAD) portion of the Phase 1 study in healthy volunteers, to be followed by a Phase 2a trial in patients with neuropathic pain. Management Commentary "These first-in-human data clearly demonstrate a favorable safety profile and predictable pharmacokinetics across a wide dosing range," said Erez Aminov, CEO of MIRA. "Importantly, the absence of the hallmark CNS side effects typically associated with ketamine, which we first observed preclinically, has now been confirmed clinically - reinforcing Ketamir-2's differentiated profile. Given the significant unmet need for safe, effective, and non-addictive treatments for neuropathic pain, we believe Ketamir-2 is well positioned as a highly attractive development candidate, and the Company is actively exploring strategic partnering opportunities to accelerate its advancement." Dr. Itzchak Angel, CSA of MIRA, added: "The Phase 1 pharmacokinetic data demonstrate that Ketamir-2 is rapidly absorbed, predictably metabolized, and suitable for once-daily dosing - a major advantage compared to oral ketamine, which suffers from poor bioavailability and short half-life. Importantly, we were able to confirm in a human clinical study that Ketamir-2 continues to differentiate itself from ketamine by showing a robust safety and pharmacokinetics profile well adapted for its intended use. These findings underscore its potential as a next-generation therapeutic." About Ketamir-2 Ketamir-2 is a proprietary, orally bioavailable new molecular entity that selectively targets the NMDA receptor (PCP site) with low affinity and shows no significant off-target activity across a broad receptor panel. Preclinical studies have demonstrated: Neuropathic pain: Superior efficacy upon oral administration versus ketamine, pregabalin, and gabapentin in gold-standard models, without the dissociative side effects associated with ketamine. PTSD: In the validated Single Prolonged Stress (SPS) model, Ketamir-2 restored normalized behavior in stressed animals, reversing hallmark PTSD-like behaviors consistent with non-stressed controls. A larger follow-on PTSD study is ongoing. Depression: Activity in established preclinical models supports the potential of Ketamir-2 as a differentiated treatment for major depressive disorders, including treatment-resistant depression (TRD). Inflammatory pain (topical formulation): In animal models, a topical formulation of Ketamir-2 demonstrated pain relief equal to injected morphine, underscoring its versatility and non-opioid potential across pain indications. The U.S. Drug Enforcement Administration's scientific review of Ketamir-2 concluded that it would not be considered a controlled substance or listed chemical under the Controlled Substances Act and its governing regulations. About MIRA Pharmaceuticals, Inc. MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders. The Company's pipeline includes oral drug candidates designed to address significant unmet medical needs in neuropathic pain, inflammatory pain, obesity, addiction, anxiety, and cognitive decline. For more information, please visit www.mirapharmaceuticals.com. Cautionary Note Regarding Forward-Looking Statements This press release and the statements of MIRA's management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and the Form 14A filed by MIRA on June 18, 2025, and other SEC filings, which are on file with the SEC at www.sec.gov and on MIRA's website at https://www.mirapharmaceuticals.com/investors/sec-filings. MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact: Helga Moya [email protected] (786) 432-9792 SOURCE: MIRA Pharmaceuticals View the original press release on ACCESS Newswire

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 extremely positive on MIRA, as 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. We urge investors to look at MIRA and suggest those with a modestly higher risk tolerance consider investing before MIRA announces more positive results or collaborations the stock really starts to move higher. SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.

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 Anxiety Disorder. “We are proud to share that all three of our pivotal Phase 3 trials evaluating MM120 ODT in patients with GAD and MDD—Voyage, Panorama, and Emerge—are actively enrolling. Momentum is building, with strong and growing enthusiasm from both clinical sites and patients as recruitment continues to accelerate,” said Rob Barrow, CEO. “We’re on track to report topline data from Voyage in the first half of 2026, followed by Panorama and Emerge in the second half of the year. With our breakthrough therapy designation in GAD, a clearly defined regulatory strategy, and strong operational execution across our programs, we’re delivering on our goal of advancing MM120 ODT as a potential best-in-class, differentiated therapeutic option. Our team remains fully committed to delivering transformational innovation for the over 50 million people in the U.S. living with GAD or MDD as we drive toward commercialization.” CYBIN ANNOUNCES U.S. PATENT GRANT: Cybin (CYBN) announced Thusday that the United States Patent and Trademark Office has granted U.S. patent 12,291,499 in support of its CYB003 program in Major Depressive Disorder. The patent, which is expected to provide exclusivity until 2041, includes claims to pharmaceutical compositions and oral dosage forms within the company’s proprietary deuterated psilocin analog program, CYB003. “Securing an additional patent in support of CYB003 provides important validation of our program and reinforces the commercial potential of our pipeline,” said Doug Drysdale, CEO. “Robust patent protection is essential for drug development companies, and we are proud of our expanding intellectual property portfolio. As we continue to dose patients in our first Phase 3 study, we are focused on execution, delivering shareholder value, and ultimately, creating more effective treatments for those with mental health disorders.” MIRA REPORTS KETAMIR-2 NEUROTOXICITY RESULTS: On Tuesday, MIRA Pharmaceuticals (MIRA) announced results from a neurotoxicity study of Ketamir-2, its novel oral NMDA receptor antagonist. The study was required by the U.S. Food and Drug Administration prior to initiating human dosing in the United States. The preclinical study showed no evidence of brain toxicity, including the absence of Olney lesions-vacuolar brain changes historically associated with older NMDA-targeting drugs such as ketamine and MK-801. The neurotoxicity study was conducted in sexually mature Sprague-Dawley rats. High oral doses of Ketamir-2 were administered, while a positive control group received MK-801, a known neurotoxic NMDA receptor antagonist. Brain tissues were examined through detailed histopathological analysis at two time points. Key outcomes included no adverse clinical signs or mortality in any Ketamir-2-treated animals; No microscopic or macroscopic brain lesions detected at any dose; MK-801-treated animals showed clear evidence of brain toxicity, including vacuolation and neuronal necrosis. “These results represent a key milestone in the development of Ketamir-2,” said Erez Aminov, CEO. “The absence of NMDA-linked neurotoxicity, along with continued clinical progress, reinforces our confidence in Ketamir-2’s potential as a safe next-generation, oral candidate for CNS disorders.” Additionally on Thursday, MIRA announced that its Board of Directors has approved the planned acquisition of SKNY Pharmaceuticals, following the completion of independent valuation reports on both companies. The merger remains subject to MIRA and SKNY’s shareholder approval. A third-party analysis conducted by Moore Financial Consulting assigned SKNY Pharmaceuticals an enterprise value of approximately $30.5M, based on a risk-adjusted net present value of its lead compound, SKNY-1. MIRA was separately valued by Moore at $30M. As outlined in the previously announced binding letter of intent for the merger, upon the closing, SKNY must hold at least $5M in cash or other assets, to be transferred at closing, and the company is preparing a filing with the U.S. Securities and Exchange Commission to seek shareholder approval. BRIGHT MINDS INITIATED WITH BUY: On Wednesday, Chardan initiated coverage of Bright Minds (DRUG) with a Buy rating and $80 price target. The firm cites the potential of the company’s lead asset BMB-101 for the treatment of epilepsy for the Buy rating. Bright Minds is an “interesting story even at current valuation: as BMB-101 could be differentiated verses other 5-HT2C agonists with its unique binding profile, and it could potentially achieve greater than $1B peak sales in epilepsy, the analyst said. NRXP FILES PATENT APPLICATION: NRx Pharmaceuticals (NRXP) announced Monday the filing of a patent application for NRX-100, its preservative-free intravenous ketamine formulation for the treatment of suicidal depression. The application discloses pharmaceutical compositions, methods of treatment and methods of manufacture and currently includes twenty claims. While subject to the patent review process of the U.S. Patent and Trademark Office, if granted, the patent would provide NRX-100 exclusivity into 2045. “We are committed to delivering safer, more effective treatments for patients with suicidal depression,” said Jonathan Javitt, CEO. “NRX-100 eliminates the need for benzethonium chloride, a compound with well-documented safety concerns, and reflects our belief that patients in crisis deserve therapies formulated with their long-term well-being in mind. With the recent FDA fee waiver now in place, we remain on track to complete our NDA submission this quarter — a critical step toward bringing this innovation to patients in need.” OTHER PSYCHEDELIC STOCKS: Publicly-traded companies in the space include Algernon Pharmaceuticals (AGNPF), Allied Corp. (ALID), atai Life Sciences (ATAI), BetterLife (BETRF), Clearmind (CMND), Entheon Biomedical (ENTBF), Enveric Biosciences (ENVB), Filament Health (FLHLF), Incannex (IXHL), Mydecine Innovations (MYCOF), Numinus Wellness (NUMIF), Optimi Health (OPTHF), Pasithea Therapeutics (KTTA), PharmAla (MDXXF), PharmaTher (PHRRF), Psyence Biomedical (PBM), Psyence Group (PSYGF), Quantum BioPharma (QNTM), Relmada Therapeutics (RLMD), Revive Therapeutics (RVVTF), SciSparc (SPRC), Seelos Therapeutics (SEEL), Silo Pharma (SILO) and Synaptogenix (SNPX). Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>> See Insiders’ Hot Stocks on TipRanks >> Read More on CMPS: Disclaimer & DisclosureReport an Issue Compass Pathways reports Q1 EPS (24c), consensus (49c) Compass Pathways enters strategic collaboration with HealthPort Psychedelic: Clearmind completes clinical site initiations for AUD trial Compass Pathways completes dosing in Part A of Phase 3 psilocybin trial COMPASS Pathways Amends Executive Employment Agreements

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 focusing on the one with the potential to get to market the fastest — Ketamir-2, but also continuing to advance MIRA-55, which we have written extensively about, in the background. We urge investors to look at MIRA and suggest those with a modestly higher risk tolerance consider investing before MIRA announces more positive results or collaborations the stock really starts to move higher. SUBSCRIBE TO ZACKS SMALL CAP RESEARCH to receive our articles and reports emailed directly to you each morning. Please visit our website for additional information on Zacks SCR. DISCLOSURE: Zacks SCR has received compensation from the issuer directly, from an investment manager, or from an investor relations consulting firm, engaged by the issuer, for providing research coverage for a period of no less than one year. Research articles, as seen here, are part of the service Zacks SCR provides and Zacks SCR receives quarterly payments totaling a maximum fee of up to $40,000 annually for these services provided to or regarding the issuer. Full Disclaimer HERE.

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 safety, tolerability, and pharmacokinetics in healthy volunteers. Completion is expected in Q4 2025, with a Phase IIa study in diabetic neuropathy patients planned to follow. "The strong alignment between this model and human pathology, together with results obtained with other experimental models, gives us a high degree of scientific confidence as we move forward," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "Seeing such robust responses in a validated model of diabetic neuropathy reinforces the potential clinical impact of Ketamir-2 and helps guide the path ahead." Addressing a Pressing Unmet Need Diabetic neuropathy affects between 28% to 55% of patients with diabetes and remains one of the most prevalent and debilitating complications associated with the disease. As global diabetes rates continue to climb, the number of patients suffering from chronic neuropathic pain is expected to rise sharply, placing an increasing burden on healthcare systems worldwide. Current treatment options are limited, with first-line therapies such as pregabalin, gabapentin, and duloxetine often delivering only modest symptom relief. These drugs are frequently associated with side effects such as dizziness, fatigue, cognitive impairment, and gastrointestinal discomfort. Up to 50% of patients fail to achieve meaningful pain reduction, underscoring the urgent need for safer and more effective alternatives. (Tesfaye et al., Diabetes Metab Res Rev. 2011) At the same time, the demand for non-opioid therapies is growing rapidly, driven by the ongoing opioid crisis and heightened regulatory scrutiny. Ketamir-2's non-addictive profile and lack of dissociative side effects position it as a strong candidate in this emerging treatment landscape. The economic burden of diabetic neuropathy is also substantial. A study published in Drugs & Aging estimated that diabetic peripheral neuropathy contributes more than $10 billion annually in direct medical costs in the U.S. alone. This includes costs related to increased hospitalizations, physician visits, disability, and lost productivity. (Gordois et al., Drugs Aging. 2003) Importantly, the FDA has previously identified neuropathic pain as a high-priority area for accelerated development, granting Fast Track and Breakthrough Therapy designations to compounds that demonstrate potential to improve outcomes over standard treatments. (FDA Guidance for Industry - Expedited Programs for Serious Conditions) MIRA believes that, with continued positive data, Ketamir-2 may be positioned to meet key criteria for future regulatory acceleration. Looking Ahead MIRA anticipates initiating its Phase IIa clinical trial in diabetic neuropathy by the end of 2025, with first human efficacy data expected in the first half of 2026. In parallel, development of a topical slow-release formulation of Ketamir-2 continues, aimed at providing localized pain relief with minimized systemic exposure. In addition, MIRA is actively conducting ongoing studies assessing the efficacy of Ketamir-2 in models of post-traumatic stress disorder (PTSD), a serious and underserved neuropsychiatric condition. MIRA remains committed to unlocking the full therapeutic potential of Ketamir-2 across multiple indications. MIRA is also pleased to report continued progress on the pending acquisition of SKNY Pharmaceuticals, a move that strengthens MIRA's strategic pipeline. MIRA is highly enthusiastic about the promise of SKNY-1, a next-generation oral therapeutic in development for the treatment of obesity and smoking cessation, two major public health challenges that lack scalable, well-tolerated solutions. About MIRA Pharmaceuticals, Inc. MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. MIRA holds the exclusive U.S., Canadian, and Mexican rights for Ketamir-2, a novel, patent-pending oral ketamine analog under investigation to treat neuropathic pain (NP), treatment-resistant depression (TRD), major depressive disorder with suicidal ideation (MDD-SI), and post-traumatic stress disorder (PTSD). MIRA's novel oral pharmaceutical marijuana analog, MIRA-55, is currently under investigation for treating adult patients suffering from anxiety and cognitive decline, often associated with early-stage dementia. If approved by the FDA, MIRA-55 could mark a significant advancement in addressing various neuropsychiatric, inflammatory, and neurologic diseases and disorders. The U.S. Drug Enforcement Administration's scientific review concluded that both Ketamir-2 and MIRA-55 would not be considered controlled substances or listed chemicals under the Controlled Substances Act and its governing regulations. Additional information about MIRA Pharmaceuticals is available at www.mirapharmaceuticals.com. Cautionary Note Regarding Forward-Looking Statements This press release and the statements of MIRA's management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. These forward-looking statements include, without limitation, statements regarding the anticipated benefits of the acquisition transaction and claims regarding SKNY-1. Any forward-looking statements in this press release are based on Mira's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and other SEC filings, which are on file with the SEC at www.sec.gov and MIRA's website at https://www.mirapharmaceuticals.com/investors/sec-filings. MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law. Contact Information Helga Moya [email protected] (786) 432-9792 SOURCE: MIRA Pharmaceuticals View the original press release on ACCESS Newswire