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MIRA Pharmaceuticals, Inc. operates as a clinical development stage biopharmaceutical company. The company focuses on the development and commercialization of a new molecular synthetic tetrahydrocannabinol (THC) analog under investigation for the treatment of adult patients with anxiety and cognitive decline typically associated with early-stage dementia. It is developing MIRA1a, a synthetic cannabinoid analog to treat anxiety and chronic pain by targeting the cannabinoid type 1 and type 2 receptors. The company was formerly known as MIRA1a Therapeutics, Inc. MIRA Pharmaceuticals, Inc. was incorporated in 2020 and is headquartered in Baltimore, Maryland.

MIRA Pharmaceuticals, Inc.

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MANUSCRIPT ACCEPTED FOR PUBLICATION IN FRONTIERS IN PHARMACOLOGY, "ORAL ADMINISTRATION OF KETAMIR-2, A NOVEL KETAMINE ANALOG, ATTENUATES NEUROPATHIC PAIN IN RODENT MODELS VIA SELECTIVE NMDA ANTAGONISM" DETAILS KETAMIR-2'S SUPERIOR PERFORMANCE IN TWO VALIDATED NEUROPATHIC PAIN MODELS AND SUPPORTS ADVANCEMENT TO PHASE 2A CLINICAL TRIALS BY YEAR-END 2025. MIAMI, FL / ACCESS NEWSWIRE / AUGUST 12, 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 THE ACCEPTANCE OF A SECOND PEER-REVIEWED MANUSCRIPT DESCRIBING ITS LEAD ORAL DRUG CANDIDATE, KETAMIR-2, IN FRONTIERS IN PHARMACOLOGY.

MIRA PHARMACEUTICALS' SECOND KETAMIR-2 MANUSCRIPT ACCEPTED FOR PEER-REVIEWED PUBLICATION DEMONSTRATING SUPERIOR EFFICACY IN PRECLINICAL NEUROPATHIC PAIN MODELS VERSUS KETAMINE, GABAPENTIN, OR PREGABALIN

TOPICAL KETAMIR-2 SIGNIFICANTLY REDUCED BOTH ACUTE AND INFLAMMATORY PAIN BEHAVIORS IN ANIMALS, DEMONSTRATING RAPID ONSET, DURABLE EFFECT, AND COMPARABLE EFFICACY TO INJECTED MORPHINE ACROSS BOTH PAIN PHASES MIAMI, FLORIDA / ACCESS NEWSWIRE / JULY 30, 2025 / MIRA PHARMACEUTICALS, INC. (NASDAQ:MIRA) ("MIRA" OR THE "COMPANY"), A CLINICAL-STAGE PHARMACEUTICAL COMPANY FOCUSED ON DEVELOPING NOVEL THERAPEUTICS FOR NEUROLOGIC, NEUROPSYCHIATRIC, AND METABOLIC DISORDERS, TODAY ANNOUNCED NEW PRECLINICAL DATA SHOWING THAT ITS TOPICAL KETAMIR-2 CREAM DELIVERED SIMILAR AND CONSISTENT PAIN RELIEF COMPARED WITH INJECTED MORPHINE IN A VALIDATED ANIMAL MODEL OF ACUTE AND INFLAMMATORY PAIN. IN THE STUDY, KETAMIR-2 CREAM WAS APPLIED TOPICALLY TO THE AFFECTED AREA 30 MINUTES BEFORE PAIN WAS INDUCED USING THE FORMALIN MODEL, A WIDELY ACCEPTED PRECLINICAL METHOD FOR EVALUATING BOTH ACUTE AND INFLAMMATORY PAIN.

MIRA PHARMACEUTICALS REPORTS NEW TOPICAL KETAMIR-2 SHOWS COMPARABLE EFFECTS TO INJECTED MORPHINE IN PRECLINICAL PAIN STUDY

ORAL, NON-OPIOID DRUG CANDIDATE ADVANCING THROUGH PHASE 1 AND NEARING COMPLETION OF THE SINGLE ASCENDING DOSE (SAD) PORTION AS THE COMPANY PREPARES TO LAUNCH U.S. PHASE 2A BY YEAR-END MIAMI, FLORIDA / ACCESS NEWSWIRE / JULY 29, 2025 / MIRA PHARMACEUTICALS, INC. (NASDAQ:MIRA), A CLINICAL-STAGE PHARMACEUTICAL COMPANY DEVELOPING NOVEL THERAPIES FOR NEUROLOGIC, NEUROPSYCHIATRIC, AND METABOLIC DISORDERS, TODAY ANNOUNCED THAT THE U.S. FOOD AND DRUG ADMINISTRATION (FDA) HAS CLEARED ITS INVESTIGATIONAL NEW DRUG (IND) APPLICATION FOR KETAMIR-2, A NOVEL ORAL NMDA RECEPTOR ANTAGONIST FOR THE TREATMENT OF NEUROPATHIC PAIN. THE IND SUBMISSION INCLUDED A COMPREHENSIVE DATA PACKAGE ENCOMPASSING PRECLINICAL PHARMACOLOGY, SAFETY, AND TOXICOLOGY STUDIES, INCLUDING A PIVOTAL NEUROTOXICITY STUDY IN SPRAGUE-DAWLEY RATS WHICH SHOWED NO EVIDENCE OF BRAIN LESIONS OR ADVERSE CNS EFFECTS-A KEY DISTINCTION FROM TRADITIONAL KETAMINE, WHICH HAS BEEN ASSOCIATED WITH NMDA-LINKED NEUROTOXICITY AND THE FORMATION OF OLNEY LESIONS IN SIMILAR PRECLINICAL MODELS.

MIRA PHARMACEUTICALS ANNOUNCES FDA CLEARANCE OF IND FOR KETAMIR-2, ENABLING U.S. CLINICAL TRIALS IN NEUROPATHIC PAIN

SKNY-1 WAS PREVIOUSLY SHOWN TO ACHIEVE UP TO 30% WEIGHT LOSS, REVERSE NICOTINE CRAVING, AND PRESERVE MUSCLE MASS IN AN ANIMAL MODEL-AND IS DESIGNED TO AVOID THE CNS SIDE EFFECTS THAT HALTED EARLIER CB1-TARGETING DRUGS MIAMI, FL / ACCESS NEWSWIRE / JULY 11, 2025 / MIRA PHARMACEUTICALS, INC. (NASDAQ:MIRA) TODAY ANNOUNCED NEW PRECLINICAL RESULTS FROM SKNY-1, AN ORAL DRUG CANDIDATE FOR OBESITY AND NICOTINE ADDICTION CURRENTLY UNDER DEFINITIVE AGREEMENT FOR ACQUISITION. IN A VALIDATED BEHAVIORAL MODEL USED TO MEASURE CANNABINOID 1 RECEPTOR (CB1) RELATED ANXIETY-LIKE EFFECTS, SKNY-1 DEMONSTRATED CLEAR REVERSAL OF ANXIETY-RELATED BEHAVIOR INDUCED BY A CB1 ACTIVATOR, SETTING IT APART FROM EARLIER CB1-TARGETING DRUGS THAT WERE DISCONTINUED DUE TO SERIOUS CENTRAL NERVOUS SYSTEM (CNS) EFFECTS.

MIRA REPORTS CLEAR REVERSAL OF ANXIETY-RELATED BEHAVIOR IN ANIMAL MODEL USING SKNY-1, AN ORAL DRUG CANDIDATE FOR OBESITY AND NICOTINE ADDICTION UNDER DEFINITIVE AGREEMENT FOR ACQUISITION

WITH MIRA-55 AND KETAMIR-2, MIRA IS ADVANCING COMPLEMENTARY NON-OPIOID THERAPIES FOR TWO OF THE LARGEST PAIN MARKETS MIAMI, FLORIDA / ACCESS NEWSWIRE / JULY 3, 2025 / MIRA PHARMACEUTICALS, INC. (NASDAQ:MIRA) ("MIRA" OR THE "COMPANY"), A CLINICAL-STAGE PHARMACEUTICAL COMPANY DEVELOPING NOVEL THERAPEUTICS FOR NEUROLOGIC, NEUROPSYCHIATRIC, AND METABOLIC DISORDERS, TODAY ANNOUNCED POSITIVE PRECLINICAL DATA DEMONSTRATING THAT MIRA-55, THE COMPANY'S PROPRIETARY NON-PSYCHOTROPIC MARIJUANA ANALOG, DELIVERED MORPHINE-COMPARABLE PAIN RELIEF IN A VALIDATED MODEL OF INFLAMMATORY PAIN-WITHOUT CAUSING LOCAL INFLAMMATION. MIRA-55 IS A NEXT-GENERATION ANALOG OF MARIJUANA, ENGINEERED TO SELECTIVELY ACTIVATE CB2 CANNABINOID RECEPTORS, WHICH ARE ASSOCIATED WITH ANTI-INFLAMMATORY AND ANALGESIC EFFECTS.

MIRA REPORTS POTENT INFLAMMATORY PAIN RELIEF FROM NON-PSYCHOACTIVE MARIJUANA ANALOG MIRA-55 IN ANIMAL MODEL, MATCHING MORPHINE WITHOUT OPIOID RISKS

ORAL THERAPY DESIGNED TO MINIMIZE CNS SIDE EFFECTS SHOWS DUAL ACTIVITY IN WEIGHT LOSS AND SMOKING CESSATION MODELS WITHOUT MUSCLE LOSS MIAMI, FLORIDA / ACCESS NEWSWIRE / JUNE 30, 2025 / MIRA (NASDAQ:MIRA) TODAY ANNOUNCED NEW ANIMAL STUDY RESULTS FROM SKNY-1, A NEXT-GENERATION ORAL THERAPEUTIC UNDER DEFINITIVE AGREEMENT FOR ACQUISITION. IN A ZEBRAFISH MODEL THAT MIMICS HUMAN OBESITY AND CRAVING BEHAVIORS, SKNY-1 DEMONSTRATED WEIGHT LOSS, SUPPRESSION OF APPETITE AND CRAVING FOR HIGH-CALORIE DIETS, AND REVERSAL OF NICOTINE-SEEKING BEHAVIOR-ALL ACHIEVED WITHIN SIX DAYS OF ORAL TREATMENT.

MIRA REPORTS UP TO 30% WEIGHT LOSS AND REVERSAL OF HIGH-CALORIE AND NICOTINE CRAVINGS IN AN ANIMAL MODEL OF OBESITY AND CRAVING USING SKNY-1, A DRUG CANDIDATE UNDER DEFINITIVE AGREEMENT FOR ACQUISITION

MIAMI, FL / ACCESS NEWSWIRE / JUNE 25, 2025 / MIRA PHARMACEUTICALS, INC. (NASDAQ:MIRA) ("MIRA" OR THE "COMPANY"), A CLINICAL-STAGE PHARMACEUTICAL COMPANY FOCUSED ON DEVELOPING NOVEL THERAPEUTICS FOR NEUROLOGIC, NEUROPSYCHIATRIC, AND METABOLIC DISORDERS, TODAY ANNOUNCED NEW IN VITRO PRECLINICAL DATA GENERATED BY EUROFINS SUPPORTING THE THERAPEUTIC POTENTIAL OF SKNY-1, A NEXT-GENERATION ORAL DRUG CANDIDATE BEING DEVELOPED BY SKNY PHARMACEUTICALS, INC. ("SKNY"). MIRA HAS SIGNED A DEFINITIVE AGREEMENT TO ACQUIRE SKNY, AND THE PROPOSED TRANSACTION REMAINS SUBJECT TO REGULATORY REVIEW AND SHAREHOLDER APPROVAL.

MIRA PHARMACEUTICALS ANNOUNCES NEW DATA UNDERSCORING POTENTIAL OF SKNY-1 - A DRUG CANDIDATE PENDING ACQUISITION - TO DISRUPT WEIGHT LOSS AND SMOKING CESSATION MARKETS WITHOUT CNS SIDE EFFECTS

MIAMI, FL / ACCESS NEWSWIRE / JUNE 18, 2025 / MIRA PHARMACEUTICALS, INC. (NASDAQ:MIRA) ("MIRA" OR THE "COMPANY"), A CLINICAL-STAGE PHARMACEUTICAL COMPANY DEVELOPING NOVEL THERAPEUTICS FOR NEUROLOGIC, NEUROPSYCHIATRIC, AND METABOLIC DISORDERS, TODAY ANNOUNCED THAT THE FIRST MANUSCRIPT DESCRIBING ITS LEAD DRUG CANDIDATE KETAMIR-2, CURRENTLY BEING EVALUATED IN AN ONGOING PHASE 1 CLINICAL TRIAL FOR NEUROPATHIC PAIN, HAS BEEN ACCEPTED FOR PUBLICATION IN THE PEER-REVIEWED JOURNAL FRONTIERS IN PHARMACOLOGY. THE ARTICLE, TITLED "KETAMIR-2, A NEW MOLECULAR ENTITY AND NOVEL KETAMINE ANALOG," AUTHORED BY ITZCHAK ANGEL, PH.D.

MIRA PHARMACEUTICALS' LEAD DRUG CANDIDATE KETAMIR-2 FIRST MANUSCRIPT ACCEPTED FOR PUBLICATION IN THE PEER-REVIEWED JOURNAL FRONTIERS IN PHARMACOLOGY

THE COMPANY WILL ENGAGE IN BIO ONE-ON-ONE PARTNERING MEETINGS AS IT ADVANCES PHASE 1 FOR KETAMIR-2, PREPARES PHASE IIA STUDY IN NEUROPATHIC PAIN, AND FINALIZES FILINGS FOR SKNY ACQUISITION. MIAMI, FL / ACCESS NEWSWIRE / MAY 28, 2025 / MIRA PHARMACEUTICALS, INC. (NASDAQ:MIRA) ("MIRA" OR THE "COMPANY"), A CLINICAL-STAGE PHARMACEUTICAL COMPANY DEVELOPING NOVEL THERAPEUTICS FOR NEUROLOGIC, NEUROPSYCHIATRIC, AND METABOLIC DISORDERS, TODAY ANNOUNCED THAT IT WILL PARTICIPATE IN THE BIO INTERNATIONAL CONVENTION 2025, TAKING PLACE IN BOSTON, MA FROM JUNE 16-19, 2025.

MIRA PHARMACEUTICALS TO PARTICIPATE IN BIO 2025 IN BOSTON AND HIGHLIGHTS ONGOING PROGRESS ACROSS CLINICAL PROGRAM

WITH VALUATIONS CONFIRMED BY THE BOARD, MIRA ADVANCES STRATEGIC ACQUISITION TARGETING OBESITY AND NICOTINE DEPENDENCE, WHICH INCLUDES A $5 MILLION CONTRIBUTION IN CASH OR ASSETS FROM SKNY TO BE TRANSFERRED AT CLOSING. MIAMI, FLORIDA / ACCESS NEWSWIRE / MAY 8, 2025 / MIRA PHARMACEUTICALS, INC. (NASDAQ:MIRA) ("MIRA" OR THE "COMPANY"), A CLINICAL-STAGE PHARMACEUTICAL COMPANY DEVELOPING NOVEL THERAPEUTICS FOR NEUROLOGIC, NEUROPSYCHIATRIC, AND METABOLIC DISORDERS, TODAY ANNOUNCED THAT ITS BOARD OF DIRECTORS HAS APPROVED THE PLANNED ACQUISITION OF SKNY PHARMACEUTICALS, INC. (THE "MERGER"), FOLLOWING THE COMPLETION OF INDEPENDENT VALUATION REPORTS ON BOTH COMPANIES.

MIRA PHARMACEUTICALS ANNOUNCES BOARD APPROVAL OF SKNY ACQUISITION REFLECTING $60+ MILLION IN COMBINED ENTERPRISE VALUE BASED ON INDEPENDENT REVIEW

PRECLINICAL DATA SUPPORTS THE ADVANCEMENT OF ORAL KETAMIR-2 AS A SAFE, NEXT-GENERATION ALTERNATIVE TO KETAMINE, WITH ONGOING MOMENTUM IN PHASE I CLINICAL TRIAL ENROLLMENT MIAMI, FL / ACCESS NEWSWIRE / MAY 6, 2025 / MIRA PHARMACEUTICALS, INC. (NASDAQ:MIRA) ("MIRA" OR THE "COMPANY"), A CLINICAL-STAGE PHARMACEUTICAL COMPANY FOCUSED ON DEVELOPING BREAKTHROUGH TREATMENTS FOR NEUROLOGICAL AND NEUROPSYCHIATRIC CONDITIONS, TODAY ANNOUNCED POSITIVE 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 (FDA) PRIOR TO INITIATING HUMAN DOSING IN THE UNITED STATES.

MIRA Pharmaceuticals, Inc.

MIRA

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