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  4. [8-K] MIRA PHARMACEUTICALS, INC. Reports Material Event

MIRA advances 2027 Ketamir-2 neuropathy trial

MIRA moves Ketamir-2 into a Phase 2a CIPN trial after FDA protocol review, targeting site initiation in early 2027 under an active IND.

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Rhea-AI Filing Summary

MIRA Pharmaceuticals, Inc. (MIRA) reported that its Phase 2a clinical program for Ketamir-2 in chemotherapy-induced peripheral neuropathy (CIPN) has advanced following U.S. FDA review of the study protocol. The updated Phase 2a protocol has been submitted for Institutional Review Board (IRB) review at a leading cancer research institution, moving the trial toward site initiation, which the company is targeting for the first quarter of 2027, subject to completion of IRB review and routine site-activation steps.

The randomized, double-blind, placebo-controlled, three-period crossover study will test oral Ketamir-2 at 300 mg and 600 mg versus placebo over three seven-day treatment periods separated by 13-day washouts, generating initial efficacy, dose-response, and expanded safety data in patients with persistent CIPN. The program builds on a completed Phase 1 study in healthy volunteers where Ketamir-2 showed a favorable safety, tolerability, and pharmacokinetic profile, with no serious adverse events or dose-limiting toxicities, and proceeds under an active IND. MIRA highlights CIPN as a significant unmet need, notes that Ketamir-2 is not classified as a controlled substance, and plans scientific presentations and business development activities in Japan in October 2026.

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Item 7.01 Regulation FD Disclosure Disclosure
Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.
Item 9.01 Financial Statements and Exhibits Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Target site initiation timing First quarter of 2027 Planned start of Phase 2a clinical site initiation for Ketamir-2 in CIPN, subject to IRB review and site activation
Ketamir-2 dose levels 300 mg and 600 mg Oral doses tested in the Phase 2a randomized, double-blind, placebo-controlled, three-period crossover CIPN study
Treatment period length Three periods of 7 days Each participant receives Ketamir-2 doses and placebo across three seven-day treatment periods
Washout duration 13 days Length of washout intervals separating each of the three treatment periods in the Phase 2a study
Conference presentation dates October 5–6, 2026 Dates for the planned oral presentation on Ketamir-2 at the International Conference on Addiction and Psychiatry in Tokyo
chemotherapy-induced peripheral neuropathy medical
"evaluating Ketamir-2 in chemotherapy-induced peripheral neuropathy (CIPN)"
Nerve damage caused by certain cancer drugs that produces numbness, tingling, pain or weakness in the hands and feet; think of it like electrical wiring in the body becoming frayed and sending poor signals. It matters to investors because this side effect can force dose cuts, treatment delays, or additional care, affecting a drug’s safety profile, clinical trial results, patient demand and overall healthcare costs — all of which influence a company’s revenue and regulatory prospects.
Institutional Review Board regulatory
"has been submitted for Institutional Review Board (IRB) review"
An institutional review board is an independent committee that reviews and approves research involving people to make sure studies are safe, ethical, and protect participants’ rights and privacy. For investors, IRB approval is a gatekeeper: it can determine whether a clinical trial can start or continue, affecting timelines, regulatory risk, cost and the credibility of trial results—similar to a safety inspector whose sign-off is required before work can proceed.
Investigational New Drug (IND) application regulatory
"The Phase 2a study will be conducted under MIRA’s active Investigational New Drug (IND) application"
An investigational new drug (IND) application is a formal request submitted to a drug regulator asking permission to begin testing a new medicine in people. It compiles lab results, manufacturing details and proposed human trial plans so regulators can judge safety before human studies start; for investors, an accepted IND is a key milestone that opens the clinical development pathway and can materially change a company’s risk profile and potential value, like getting a license to road-test a prototype.
NMDA receptor modulator medical
"Ketamir-2 is being developed as an oral NMDA receptor modulator"
An NMDA receptor modulator is a drug or compound that adjusts the activity of NMDA receptors, a type of protein on brain cells that helps control communication involved in learning, memory and mood. Think of it like turning a dial on the volume of specific brain signaling pathways: small changes can improve symptoms in conditions like depression, Alzheimer's or chronic pain, while larger changes can cause side effects. For investors, these modulators matter because clinical trial results, safety profiles and regulatory decisions determine the commercial potential and value of companies developing them.
double-blind, placebo-controlled, three-period crossover study medical
"The randomized, double-blind, placebo-controlled, three-period crossover study will enroll adults"
Schedule III controlled-substance status regulatory
"and its Schedule III controlled-substance status"

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did MIRA (MIRA) announce regarding Ketamir-2 in this 8-K?
MIRA announced that, after FDA review and comments, the Phase 2a protocol for Ketamir-2 in chemotherapy-induced peripheral neuropathy has been submitted for IRB review at a leading cancer research institution, moving the program toward clinical site initiation targeted for the first quarter of 2027.

What is the design of MIRA’s Phase 2a Ketamir-2 study for CIPN?
The Phase 2a trial is a randomized, double-blind, placebo-controlled, three-period crossover study in adults with moderate-to-severe persistent CIPN. Participants receive Ketamir-2 at 300 mg, 600 mg, and placebo in three seven-day treatment periods, each separated by 13-day washout intervals.

When does MIRA (MIRA) expect Ketamir-2 Phase 2a site initiation?
MIRA is targeting Phase 2a site initiation for Ketamir-2 in chemotherapy-induced peripheral neuropathy in the first quarter of 2027, subject to completion of IRB review and other routine site activation requirements at the participating cancer research institution.

What prior clinical data does MIRA have on Ketamir-2?
MIRA states that Ketamir-2 has completed a Phase 1 clinical program in healthy volunteers, where it showed a favorable safety, tolerability, and pharmacokinetic profile, with no serious adverse events and no dose-limiting toxicities reported, supporting advancement into the Phase 2a CIPN study.

Why is Ketamir-2 potentially differentiated in neuropathic pain for MIRA (MIRA)?
Ketamir-2 is described as an oral NMDA receptor modulator designed to engage a validated analgesic pathway while potentially addressing ketamine’s limitations, including intravenous administration and neuropsychiatric effects. MIRA notes Ketamir-2’s once-daily Phase 1 pharmacokinetics and that it is not classified as a controlled substance by the DEA.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): September 17, 2026

 

MIRA PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in its Charter)

 

Florida   001-41765   85-3354547
(State or Other Jurisdiction   (Commission   (IRS Employer
of Incorporation)   File Number)   Identification No.)

 

1200 Brickell Avenue, Suite 1950 #1183

Miami, Florida 33131

(Address of Principal Executive Offices)

 

Registrant’s telephone number, including area code: (786) 432-9792

 

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
   
☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
   
☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
   
☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class   Trading Symbol   Name of each exchange on which registered
Common Stock, $0.0001 par value per share   MIRA   The Nasdaq Capital Market

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ☒

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 

 

 

 

 

Item 7.01 Regulation FD Disclosure.

 

On September 17, 2026, MIRA Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that its Phase 2a clinical program evaluating Ketamir-2 in chemotherapy-induced peripheral neuropathy (“CIPN”) has advanced toward site initiation following review of the study protocol by the U.S. Food and Drug Administration (“FDA”). Following FDA review and comments, the Company incorporated the FDA’s feedback into the Phase 2a protocol, which has been submitted for Institutional Review Board review at a leading cancer research institution.

 

A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

 

The information contained in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

 

Cautionary Note Regarding Forward-Looking Statements

 

This report 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 report speak only as of the date of this report, 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.

 

Item 9.01 Financial Statements and Other Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Description
99.1   Press Release of MIRA Pharmaceuticals, Inc., dated September 17, 2026
104   Cover Page Interactive Data File (embedded within the Inline XBRL document)

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  MIRA PHARMACEUTICALS, INC.
   
Dated: September 17, 2026 By: /s/ Erez Aminov
  Name: Erez Aminov
  Title: Chief Executive Officer

 

 

 

 

Exhibit 99.1

 

MIRA Pharmaceuticals Advances Ketamir-2 to Phase 2a in Chemotherapy-Induced Peripheral Neuropathy (CIPN) Following FDA Review

 

Protocol Submitted for IRB Review at a Leading Cancer Research Institution, Advancing the Study Toward Site Initiation

 

MIAMI, Sept. 17, 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 that, following review and comments from the U.S. Food and Drug Administration (FDA), the Phase 2a protocol evaluating Ketamir-2 in chemotherapy-induced peripheral neuropathy (CIPN) has been submitted for Institutional Review Board (IRB) review at a leading cancer research institution.

 

MIRA incorporated the FDA’s feedback into the protocol and is targeting site initiation in the first quarter of 2027, subject to completion of IRB review and other routine site activation requirements. The study represents Ketamir-2’s first clinical evaluation in patients with CIPN and is designed to generate initial efficacy and dose-response data while further characterizing safety and tolerability.

 

“We are entering an important stage for Ketamir-2 as we prepare to evaluate the drug for the first time in patients with persistent CIPN,” said Erez Aminov, CEO of MIRA. “This marks the transition from establishing safety and pharmacokinetics in healthy volunteers to evaluating Ketamir-2’s potential therapeutic effect in patients.”

 

About the Phase 2a Study

 

The randomized, double-blind, placebo-controlled, three-period crossover study will enroll adults with moderate-to-severe persistent CIPN. Participants will receive Ketamir-2 at 300 mg and 600 mg, as well as placebo, in a defined treatment sequence across three seven-day treatment periods separated by 13-day washout periods, allowing each participant to serve as their own control.

 

The study will evaluate the safety, tolerability, efficacy, and dose-response relationship of oral Ketamir-2, including its effect on post-chemotherapy neuropathic pain intensity. Additional assessments will evaluate CIPN-related symptoms and functional status, as well as potential central nervous system adverse effects.

 

The study builds on MIRA’s completed Phase 1 clinical program in healthy volunteers, in which Ketamir-2 demonstrated a favorable safety, tolerability, and pharmacokinetic profile, with no serious adverse events or dose-limiting toxicities reported. The Phase 2a study will be conducted under MIRA’s active Investigational New Drug (IND) application.

 

Addressing a Significant Unmet Need in Neuropathic Pain

 

CIPN is a painful and potentially persistent complication of certain commonly used chemotherapies that can continue long after cancer treatment has ended. Treatment options remain limited, and there are currently no FDA-approved therapies specifically indicated for CIPN. Existing treatment approaches offer limited options for managing painful CIPN, underscoring the need for new therapies specifically developed for this condition.

 

Ketamine has demonstrated analgesic activity in neuropathic pain through modulation of the NMDA receptor pathway, supporting the therapeutic relevance of this mechanism. However, its broader use as a chronic treatment can be constrained by intravenous administration, dissociative and other neuropsychiatric effects, monitoring requirements, and its Schedule III controlled-substance status.

 

Ketamir-2 is being developed as an oral NMDA receptor modulator designed to engage this therapeutically relevant pathway while potentially overcoming key limitations associated with ketamine. Ketamir-2 is orally administered; its Phase 1 pharmacokinetic profile supports once-daily dosing, and it is not classified as a controlled substance by the U.S. Drug Enforcement Administration (DEA).

 

“There is a strong scientific rationale for targeting NMDA receptor signaling in neuropathic pain,” said Itzchak Angel, Ph.D., Chief Scientific Advisor of MIRA. “Ketamine has provided important clinical validation of this pathway, but its properties can limit its practicality for chronic use. Ketamir-2 was designed as an oral NMDA receptor modulator with high selectivity and a differentiated pharmacologic profile, and we believe this Phase 2a study will provide an important first opportunity to determine whether this profile can translate into meaningful pain reduction in patients with persistent CIPN.”

 

While CIPN is the initial patient population being evaluated in Phase 2a, MIRA believes that positive clinical evidence in CIPN could support the evaluation of Ketamir-2 across additional neuropathic pain conditions where NMDA receptor signaling may play a role. The Company views CIPN as a potential clinical entry point into the broader neuropathic pain market.

 

 

 

 

October Scientific Presentation and BioJapan Participation

 

MIRA expects to present Ketamir-2 at the International Conference on Addiction and Psychiatry in Tokyo, Japan, on October 5–6, 2026, where an abstract titled “An Oral Selective NMDA Modulator for Chemotherapy-Induced Peripheral Neuropathy—Phase 1 Safety, Pharmacokinetics, and Clinical Development Update” has been accepted for oral presentation by Dr. Itzchak Angel, MIRA’s Chief Scientific Advisor.

 

MIRA also expects to participate in BioJapan in October as the Company continues licensing and strategic partnership discussions around Ketamir-2 and its broader pipeline.

 

About Ketamir-2

 

Ketamir-2 is MIRA Pharmaceuticals’ proprietary oral NMDA receptor modulator in clinical development for neuropathic pain. The compound is designed to selectively modulate the NMDA receptor PCP binding site with low binding affinity and limited off-target receptor activity.

 

MIRA holds exclusive worldwide rights to Ketamir-2 and is pursuing intellectual property protection across major global pharmaceutical markets.

 

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 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.

 

Investor and Media Contact

 

Krystina Quintana

MIRA Pharmaceuticals

info@mirapharma.com

(786) 432-9792

 

 

 

Source: View Original Filing on SEC EDGAR

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