Ketamir-2 outperforms ketamine, plans Phase 2a FDA submission in Q4 2025

Rhea-AI Filing Summary

MIRA Pharmaceuticals announced on August 12, 2025 that a manuscript describing its lead candidate, Ketamir-2, was accepted for publication in Frontiers in Pharmacology. The paper reports that Ketamir-2 outperformed ketamine, pregabalin, or gabapentin in two validated preclinical models of neuropathic pain, restoring sensory function and reversing pain behaviors across genders and species. The company cites epidemiology that 7–10% of the population experiences neuropathic pain, equal to 36–51 million people in North America, and cites market estimates of $7.97 billion globally in 2024 growing to $16.79 billion by 2034.

MIRA states these findings support its plan to submit a Phase 2a clinical trial protocol to the FDA in Q4 2025 as a follow-up to its active IND, with the goal of initiating a neuropathic pain study by year-end. The company is also evaluating Ketamir-2 for other CNS indications including depression, anxiety, PTSD, and a topical formulation for localized pain.

Positive

• Manuscript accepted for publication in Frontiers in Pharmacology, offering peer-reviewed validation of the data
• Ketamir-2 outperformed ketamine, pregabalin, or gabapentin in two validated preclinical neuropathic pain models
• Preclinical effects observed across genders and species, and described restoration of sensory function and reversal of pain behaviors
• Company plans to submit a Phase 2a clinical trial protocol to the FDA in Q4 2025 and aims to initiate the study by year-end
• Large addressable market cited: neuropathic pain market estimates presented, including global and North American figures

Negative

• Data are preclinical; the filing does not report clinical efficacy or human safety results
• No financial or enrollment details for planned clinical work are provided in this report
• Timeline stated as a goal to initiate the Phase 2a study by year-end after a Q4 2025 submission, but the filing does not confirm definitive trial start or logistics

Insights

Clinical Development Specialist

TL;DR: Peer-reviewed preclinical superiority supports moving toward human efficacy testing; Phase 2a filing planned in Q4 2025.

The acceptance of a peer-reviewed manuscript in Frontiers in Pharmacology provides external validation of the preclinical dataset showing Ketamir-2 outperformed standard comparators in two validated neuropathic pain models across sexes and species. That breadth of preclinical effect and a noted favorable safety profile strengthen a rationale for a Phase 2a protocol. The announced plan to submit to the FDA in Q4 2025 and the goal to initiate the study by year-end are meaningful development milestones that, if met, would transition the program from preclinical to early clinical evaluation.

Securities Analyst

TL;DR: Positive scientific progress and clear milestones, but clinical validation and funding remain determinants of shareholder value.

The filing highlights a peer-reviewed publication and a target regulatory milestone (Phase 2a submission in Q4 2025). The release also cites market-size estimates for neuropathic pain and expanded indication opportunities, which frame potential commercial upside. From a market perspective, publication acceptance and an active IND followed by a Phase 2a submission are constructive developments, though material valuation impacts will depend on clinical outcomes, trial execution, and financing not detailed in this report.

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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): August 12, 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’ Second Ketamir-2 Manuscript Accepted for Peer-Reviewed Publication Demonstrating Superior Efficacy in Preclinical Neuropathic Pain Models versus Ketamine, Gabapentin, or Pregabalin

On August 12, 2025, MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) (“MIRA” or the “Company”) announced that a new manuscript describing its lead drug candidate, Ketamir-2, has been accepted for publication in the peer-reviewed journal Frontiers in Pharmacology. The accepted manuscript reports that Ketamir-2 outperformed ketamine, pregabalin, or gabapentin—depending on the comparator used—in two validated preclinical models of neuropathic pain, restoring sensory function and reversing pain behaviors across genders and species.

Neuropathic pain represents a significant and underserved market across North America. Epidemiology suggests approximately 7–10% of the population experiences neuropathic pain; in North America, this equates to approximately 36–51 million people across the U.S., Canada, and Mexico. According to Precedence Research, the global neuropathic pain market is valued at approximately $7.97 billion in 2024 and is projected to reach $16.79 billion by 2034, growing at a compound annual growth rate (CAGR) of 7.73%. North America accounts for a significant share of this market, representing an estimated $3.7–3.9 billion annually today. The U.S. neuropathic pain market is estimated at $2.79 billion in 2024 and is projected to reach $5.92 billion by 2034, growing at a CAGR of 7.80% over the same period.

These findings build on MIRA’s previously published characterization of Ketamir-2’s differentiated pharmacology and favorable safety profile and support the Company’s plan to submit a Phase 2a clinical trial protocol to the U.S. Food and Drug Administration (FDA) in Q4 2025 as a follow-up development to its active IND, with the goal of initiating the study in neuropathic pain by year-end. MIRA is also evaluating Ketamir-2’s potential in additional central nervous system indications, including depression, anxiety, post-traumatic stress disorder (PTSD), and as a topical formulation for localized pain conditions.

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: August 12, 2025	By:	/s/ Erez Aminov
	Name:	Erez Aminov
	Title:	Chief Executive Officer

FAQ

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

MIRA announced that a manuscript on Ketamir-2 was accepted for publication in Frontiers in Pharmacology describing preclinical superiority in neuropathic pain models.

What do the preclinical results report for Ketamir-2?

The accepted manuscript reports Ketamir-2 outperformed ketamine, pregabalin, or gabapentin in two validated preclinical neuropathic pain models and restored sensory function while reversing pain behaviors.

What are MIRA's next regulatory steps and timing?

MIRA plans to submit a Phase 2a clinical trial protocol to the FDA in Q4 2025 as a follow-up to its active IND and has the goal of initiating the neuropathic pain study by year-end 2025.

Does the filing include market size estimates for neuropathic pain?

Yes. The filing cites an estimated 7–10% population prevalence (~36–51 million in North America) and market estimates of $7.97B global in 2024 growing to $16.79B by 2034; North America is cited at $3.7–3.9B and the U.S. at $2.79B in 2024.

Is Ketamir-2 being evaluated for other indications?

Yes. The company is evaluating Ketamir-2 for additional CNS indications including depression, anxiety, PTSD, and as a topical formulation for localized pain conditions.