Highest-materiality recent filing
MIRA Pharma reports preclinical data showing Mira-55 differentiated from THC, anxiolytic effect
Mira-55 did not produce THC-like locomotor suppression or catalepsy in standard preclinical assays.
MIRA submits Phase 2a protocol to FDA for Ketamir-2 in CIPN
Phase 2a protocol (Mira-002) for oral NMDA receptor modulator Ketamir-2 in chemotherapy-induced peripheral neuropathy.
MIRA secures worldwide rights for Ketamir-2, expands IP to 10 markets ahead of Phase 2a
Amendment expands licensed territory from US, Canada, Mexico to all countries with patent rights.
Mira Pharmaceuticals announces positive Phase 1 results for Ketamir-2; plans Phase 2a in CIPN
Phase 1 trial in 57 healthy volunteers; all completed with no withdrawals or serious adverse events.
MIRA Pharma initiates final cohort of Ketamir-2 Phase 1 MAD trial; 50 volunteers dosed
Phase 1 MAD trial final cohort dosing underway; 50 healthy volunteers dosed, 6 remaining; completion expected by Q1 2026.
MIRA Pharmaceuticals increases ATM offering capacity by $15.2M
Filed prospectus supplement to raise additional $15,241,591 via ATM offering.
MIRA Pharmaceuticals starts MAD Phase 1 of oral Ketamir-2; selects CIPN for Phase 2a
Initiated multiple ascending dose (MAD) portion of Phase 1 trial for oral Ketamir-2 in healthy volunteers.
MIRA Pharmaceuticals sells 1.75M shares at $2.19 each in block deal, raising ~$3.84M
Sold 1,751,000 shares to institutional investors at avg price of $2.19/share, a 66% premium to prior day's close.
Oral Mira-55 normalized pain thresholds to baseline and reduced paw edema in formalin-induced chronic pain model, outperforming injected morphine.
MIRA completes SKNY acquisition, adds three pipeline programs; regains Nasdaq compliance
Acquired 100% of SKNY for restricted MIRA shares; SKNY contributed $5M in marketable securities to MIRA.
MIRA Pharma Phase 1 SAD of Ketamir-2 safe, well tolerated; positive PK
Phase 1 SAD study in 32 healthy volunteers (50-600 mg doses) showed no severe or serious adverse events.
MIRA announces positive preclinical PTSD data for Ketamir-2 in rat model
Ketamir-2 reversed stress-induced avoidance, anxiety, and despair in rats after 5 daily oral doses.
Shareholders approve SKNY acquisition; combined enterprise value >$60M
SKNY will contribute $5M in cash or assets to MIRA at closing.
MIRA Pharmaceuticals completes Phase 1 SAD for Ketamir-2; no safety issues, advances to MAD
Completed SAD phase with 32 participants across 4 cohorts (50-600 mg); no severe adverse effects observed.
Ketamir-2 manuscript accepted in Frontiers in Pharmacology; outperformed ketamine, pregabalin, gabapentin in preclinical models.
MIRA reports preclinical data: topical Ketamir-2 comparable to injected morphine in pain model
Topical Ketamir-2 nearly eliminated paw licking and markedly reduced paw lifting in both acute (0-10 min) and inflammatory (15-60 min) phases.
MIRA Pharma receives FDA IND clearance for Ketamir-2, advancing neuropathic pain program
FDA cleared IND for Ketamir-2, an oral NMDA antagonist for neuropathic pain, enabling U.S. clinical trials.
MIRA Pharmaceuticals sells 1.55M shares at $1.2981, raising ~$2.0M via ATM facility
Sold 1,550,741 shares to institutional investor in block sales on July 3, 2025.
Mira-55 shows morphine-comparable pain relief in animal model; SKNY acquisition clears SEC review
Mira-55, a non-psychoactive marijuana analog, matched morphine's pain relief in a formalin-based rodent model without sedation or inflammation.
MIRA reports SKNY-1 achieves 30% weight loss and reverses cravings in zebrafish obesity model
SKNY-1 reduced body weight by ~30% in six days; treated animals weighed ~10% less than healthy controls.
SKNY-1 shows biased CB1 antagonism: blocks β-arrestin (cravings) but spares G-protein (mood stability), unlike rimonabant.
MIRA Pharma announces Ketamir-2 publication, Phase 1 progress, SKNY acquisition update
Ketamir-2 accepted for publication in Frontiers in Pharmacology; highlights selective NMDA antagonism, no hyperlocomotion, improved oral bioavailability.
MIRA Pharmaceuticals to acquire SKNY; combined enterprise value over $60M
Board unanimously approved definitive agreement to acquire SKNY on April 30, 2025.
MIRA receives Nasdaq minimum equity deficiency notice; equity $2.2M vs $2.5M
Stockholders' equity $2,199,750 as of Dec 31, 2024, below Nasdaq's $2.5M minimum requirement under Rule 5550(b)(1).
MIRA Pharmaceuticals enrolls first subjects in Phase 1 trial of Ketamir-2 for neuropathic pain
Phase 1 trial of oral ketamine analog Ketamir-2 for neuropathic pain; 56 healthy volunteers in SAD/MAD cohorts.
MIRA Pharma to acquire SKNY in stock-for-stock deal; adds weight loss drug SKNY-1
SKNY contributes $5M in cash/assets at closing, no contingencies.
Mira Pharmaceuticals develops topical Ketamir-2 for localized pain; preclinical study underway
Topical Ketamir-2 designed for slow release, enabling targeted pain relief with minimal systemic exposure.
MIRA Pharma receives Israeli MoH approval to start Phase 1 trial for Ketamir-2 in neuropathic pain
Approval from Israeli Ministry of Health and IRB to initiate Phase 1 trial for Ketamir-2, an oral ketamine analog.
MIRA Pharmaceuticals replaces auditor Cherry Bekaert with Salberg; material weaknesses cited
Cherry Bekaert resigned as auditor effective Dec 16, 2024; no disagreements but noted material weaknesses in internal controls for 2022 and 2023.
MIRA submits IND for Ketamir-2 (neuropathic pain) to FDA; Phase I expected Q1 2025
IND submitted to FDA on Dec 19, 2024 for Ketamir-2, a novel oral ketamine analog.
Successful completion of GLP preclinical safety program for Ketamir-2; no adverse findings across cardiovascular, CNS, respiratory, and toxicology studies.
Ketamir-2 demonstrated 60% greater efficacy than FDA-approved gabapentin in a preclinical model of chemotherapy-induced neuropathic pain.
Mira Pharma reports Ketamir-2 beats Gabapentin and Pregabalin in preclinical neuropathic pain study
Ketamir-2 demonstrated significantly greater efficacy than FDA-approved Gabapentin (Neurontin) and Pregabalin (Lyrica) in preclinical neuropathic pain models.
Mira Pharma selects neuropathic pain for Ketamir-2, submits pre-IND request to FDA
Selected neuropathic pain as primary indication for oral ketamine analog Ketamir-2.
MIRA Pharma reports 100% pain signal reversal with oral Ketamir-2 in rat neuropathic pain model
Low oral doses of Ketamir-2 reversed neuropathic pain for 14-22 days in nerve-ligation rat model.
On June 2, 2026, the board of directors of the Company appointed Andriy Mushak to serve as the Company’s fractional Chief Financial Officer, effective as of June 6, 2026 (the “Effective Date”).
Effective June 6, 2026, Alan Weichselbaum will be no longer serving as the Chief Financial Officer of Mira Pharmaceuticals, Inc. (the “Company”).
Effective May 15, 2025, the Company appointed Alan Weichselbaum as the Chief Financial Officer of the Company.
Effective May 16, 2025, Michelle Yanez and the Company mutually agreed to release Ms. Yanez from her position as Chief Financial Officer, Treasurer and Secretary of MIRA Pharmaceuticals, Inc. (the “Company”), effective on that date.
On March 13, 2024, the remaining members of the Board (Erez Aminov and Michael Jerman) unanimously approved the appointment of (i) Mr. Aminov, the Company’s Chief Executive Officer, as Chairman of the Board and (ii) Dr. Matthew P. Del Giudice, Dr. Denil N. Shekhat and Mr. Ned MacPherson as members of the Board, to fill the vacancies on the Board occasioned by the resignations from the Board described above
Ms. Talhia Tuck, Mr. Brad Kroenig and Mr. Hugh McColl, each voluntarily resigned from the Board, effective immediately.
Also on March 9, 2024, Dr. Chris Chapman notified the Board and senior Company management of his resignation both as Executive Chairman and as an employee of the Company, effective immediately, citing his desire to focus his time on his role as Chairman and Chief Executive Officer of Telomir Pharmaceuticals, Inc.
On March 13, 2024, the remaining members of the Board (Erez Aminov and Michael Jerman) unanimously approved the appointment of (i) Mr. Aminov, the Company’s Chief Executive Officer, as Chairman of the Board and (ii) Dr. Matthew P. Del Giudice, Dr. Denil N. Shekhat and Mr. Ned MacPherson as members of the Board, to fill the vacancies on the Board occasioned by the resignations from the Board described above
On March 13, 2024, the remaining members of the Board (Erez Aminov and Michael Jerman) unanimously approved the appointment of (i) Mr. Aminov, the Company’s Chief Executive Officer, as Chairman of the Board and (ii) Dr. Matthew P. Del Giudice, Dr. Denil N. Shekhat and Mr. Ned MacPherson as members of the Board, to fill the vacancies on the Board occasioned by the resignations from the Board described above
Ms. Talhia Tuck, Mr. Brad Kroenig and Mr. Hugh McColl, each voluntarily resigned from the Board, effective immediately.
On March 13, 2024, the remaining members of the Board (Erez Aminov and Michael Jerman) unanimously approved the appointment of (i) Mr. Aminov, the Company’s Chief Executive Officer, as Chairman of the Board and (ii) Dr. Matthew P. Del Giudice, Dr. Denil N. Shekhat and Mr. Ned MacPherson as members of the Board, to fill the vacancies on the Board occasioned by the resignations from the Board described above
Ms. Talhia Tuck, Mr. Brad Kroenig and Mr. Hugh McColl, each voluntarily resigned from the Board, effective immediately.
Max materiality 0.85 · Median 0.60 · Most common event other_material