Preclinical PTSD study backs MIRA (NASDAQ: MIRA) drug Ketamir-2

Rhea-AI Filing Summary

MIRA Pharmaceuticals reported positive preclinical results for its oral drug candidate Ketamir-2 in an animal model of post-traumatic stress disorder (PTSD). In a proof-of-concept study using the Single Prolonged Stress model in rats, repeated predator exposure produced persistent PTSD-like behaviors such as increased despair, immobility, and avoidance of coping. After five days of once-daily oral Ketamir-2, these behaviors shifted back toward levels seen in non-stressed animals, suggesting a normalization of stress-related responses.

The company notes that this initial validation supports the study design and that a larger PTSD study is ongoing. Ketamir-2 is already in an ongoing Phase 1 clinical trial for neuropathic pain, where it has shown a favorable safety profile so far. The compound is a proprietary, orally bioavailable NMDA receptor modulator designed to retain ketamine-like therapeutic effects while reducing dissociative and other central nervous system side effects. A U.S. Drug Enforcement Administration scientific review concluded Ketamir-2 is not a controlled substance, and earlier preclinical work showed superior efficacy versus ketamine, pregabalin, and gabapentin in neuropathic pain models.

Insights

Biotech clinical development analyst

Early PTSD animal data for Ketamir-2 are encouraging but still very preliminary.

The company describes a proof-of-concept PTSD study in rats where repeated predator stress led to persistent PTSD-like behaviors, including increased immobility and avoidance. After five days of once-daily oral Ketamir-2, these behaviors reportedly moved back toward those seen in non-stressed animals, which supports the drug’s mechanistic rationale in stress-related conditions.

Ketamir-2 targets the NMDA receptor (PCP site) with low affinity and was designed to capture ketamine’s therapeutic benefits while limiting dissociative and other central nervous system side effects. The mention of a favorable safety profile in an ongoing Phase 1 neuropathic pain trial and prior preclinical efficacy versus ketamine, pregabalin, and gabapentin in pain models broadens its potential use beyond PTSD. A U.S. Drug Enforcement Administration review concluding it is not a controlled substance may simplify future prescribing and logistics if it advances clinically.

However, these PTSD results are based on a small animal study, and translation from rodent models to human PTSD is uncertain. The company notes that a larger PTSD study is underway, and outcomes from that work and from the ongoing Phase 1 neuropathic pain trial will be key to understanding Ketamir-2’s clinical promise.

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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 15, 2025

MIRA PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in its Charter)

Florida		001-41765		85-3354547
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer 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 8.01 Other Events

MIRA Pharmaceuticals Reports Positive PTSD Data Demonstrating Ketamir-2 Restores Normalized Behavior in Stressed Animals

MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) today announced results from a proof-of-concept validation study evaluating its oral drug candidate, Ketamir-2, in an animal model of post-traumatic stress disorder (PTSD). The study was conducted in a small group of rats using the Single Prolonged Stress (SPS) model, a widely accepted paradigm for inducing PTSD-like symptoms. Animals were exposed twice to a predator stressor (bobcat urine), which induced avoidance behavior, anxiety-like responses, and depressive-like symptoms that persisted and intensified over time, modeling chronic PTSD-like states.

Following the development of these symptoms, animals were dosed orally with Ketamir-2 once daily for five consecutive days. Behavioral assessments included anxiety-and coping/resilience-related behavior in the forced swim test (FST), which measures immobility versus active coping strategies. Stressed animals displayed hallmark PTSD-like behaviors, including increased despair, immobility, and avoidance of coping. Treatment with Ketamir-2 was associated with a reversal of these types of behaviors toward the level observed in non-stressed animals.

This initial validation supports the study design, and a larger follow-on PTSD study is ongoing. Ketamir-2 is also being evaluated in an ongoing Phase 1 clinical trial for neuropathic pain, where it has demonstrated a favorable safety profile to date.

Ketamir-2 is a proprietary, orally bioavailable new molecular entity that selectively targets the NMDA receptor (PCP site) with low affinity and has shown no significant off-target activity across a broad receptor panel. It was designed to capture the therapeutic efficacy of ketamine while minimizing dissociative and other central nervous system side effects that limit ketamine’s clinical use. 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. In prior preclinical studies, Ketamir-2 demonstrated superior efficacy compared to ketamine, pregabalin, and gabapentin in neuropathic pain models.

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 15, 2025	By:	/s/ Erez Aminov
	Name:	Erez Aminov
	Title:	Chief Executive Officer

FAQ

What did MIRA (MIRA) announce about Ketamir-2 in this 8-K?

MIRA reported positive proof-of-concept results showing that its oral drug candidate Ketamir-2 reversed PTSD-like behaviors in a rat Single Prolonged Stress model, normalizing behavior toward that of non-stressed animals.

What is Ketamir-2 and how does it work according to MIRA?

Ketamir-2 is a proprietary, orally bioavailable new molecular entity that selectively targets the NMDA receptor (PCP site) with low affinity and showed no significant off-target activity across a broad receptor panel, aiming to preserve ketamine’s benefits while reducing dissociative and other CNS side effects.

What were the key findings from the PTSD animal study for MIRAs Ketamir-2?

In rats exposed twice to a predator stressor that induced persistent PTSD-like symptoms, five days of once-daily oral Ketamir-2 treatment was associated with a reversal of increased despair, immobility, and avoidance of coping toward behavior seen in non-stressed animals.

What stage of development is Ketamir-2 currently in?

Ketamir-2 is being tested in an ongoing Phase 1 clinical trial for neuropathic pain, where it has shown a favorable safety profile to date, and a larger follow-on PTSD study is also ongoing.

What did the U.S. Drug Enforcement Administration conclude about Ketamir-2?

The U.S. Drug Enforcement Administrations scientific review concluded that Ketamir-2 would not be considered a controlled substance or listed chemical under the Controlled Substances Act and its regulations.

How has Ketamir-2 performed in prior preclinical pain studies?

In earlier preclinical neuropathic pain models, Ketamir-2 demonstrated superior efficacy compared to ketamine, pregabalin, and gabapentin, according to the company.