MIRA Pharmaceuticals to Participate in BIO 2025 in Boston and Highlights Ongoing Progress Across Clinical Program

Rhea-AI Summary

MIRA Pharmaceuticals (NASDAQ:MIRA) announced its participation in the BIO International Convention 2025 in Boston from June 16-19, where it will explore potential licensing, partnerships, and M&A opportunities. The company reported progress on multiple fronts: its lead candidate Ketamir-2, an oral ketamine analog, has completed its second dosing cohort in Phase 1 trials and is preparing for Phase IIa studies in neuropathic pain by year-end. MIRA is also conducting preclinical studies for Ketamir-2 in PTSD and developing a topical formulation for localized inflammatory pain. Additionally, the company is finalizing regulatory filings for its acquisition of SKNY Pharmaceuticals, whose candidate SKNY-1 targets smoking cessation and obesity through CB1, CB2, and MAO-B receptor activity.

Positive

• Phase 1 trial for Ketamir-2 progressing with second dosing cohort completed
• Planned initiation of Phase IIa study in neuropathic pain by end of 2025
• Strategic expansion through SKNY Pharmaceuticals acquisition
• Multiple potential applications for Ketamir-2 including PTSD and inflammatory pain

Negative

• None.

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. The Company has a full schedule of BIO One-on-One Partnering™ meetings planned as it explores potential licensing, strategic partnerships, and M&A opportunities.

The Company's lead candidate, Ketamir-2, a next-generation oral ketamine analog, is currently undergoing a Phase 1 clinical trial. With the second dosing cohort completed, the Company is now preparing to initiate the third cohort. Building on this momentum, MIRA anticipates initiating a Phase IIa study in neuropathic pain before the end of the year, advancing the development of what the Company believes could be a safe, effective non-opioid alternative for chronic pain management.

In addition, MIRA is advancing a series of preclinical studies with Ketamir-2, including models evaluating its potential in PTSD, as well as a topical formulation aimed at treating localized inflammatory pain. The Company is also finalizing regulatory filings related to its acquisition of SKNY Pharmaceuticals, Inc. ("SKNY"), with submission to the U.S. Securities and Exchange Commission (SEC) expected in the coming weeks. SKNY-1, SKNY's primary pharmaceutical candidate, is being developed as an oral therapeutic targeting smoking cessation and obesity, with activity at CB1, CB2, and MAO-B receptors.

"Our pipeline is advancing on all fronts, and we are focused on turning this scientific momentum into long-term value for patients and shareholders," said Erez Aminov, Chief Executive Officer of MIRA. "As we move closer to initiating Phase IIa and completing the SKNY transaction, we're actively exploring strategic opportunities to accelerate growth, including licensing and partnerships-especially in areas like chronic pain where non-opioid alternatives like Ketamir-2 are urgently needed."

Dr. Angel, Chief Scientific Advisor at MIRA, added:
"We believe Ketamir-2 is paving the way for a new class of non-opioid therapies. The science is compelling, and the progress we have made is truly exciting. I look forward to sharing the depth of our work and the promising data we've generated with potential partners and investors."

Cautionary Note Regarding Forward-Looking Statements
This press release and the statements of MIRA's management related thereto contain "forward-looking statements," which are statements other than historical facts made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements may be identified by words such as "aims," "anticipates," "believes," "could," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words or similar expressions that are intended to identify forward-looking statements. Any statements in this press release that are not historical facts may be deemed forward-looking. Any forward-looking statements in this press release are based on MIRA's current expectations, estimates, and projections only as of the date of this release and are subject to a number of risks and uncertainties (many of which are beyond MIRA's control) that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements, including related to MIRA's potential merger with SKNY Pharmaceuticals, Inc. These and other risks concerning MIRA's programs and operations are described in additional detail in the Annual Report on Form 10-K for the year ended December 31, 2024, and other SEC filings, which are on file with the SEC at www.sec.gov and MIRA's website at https://www.mirapharmaceuticals.com/investors/sec-filings. MIRA explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

Contact Information
Helga Moya
info@mirapharma.com
(786) 432-9792

SOURCE: MIRA Pharmaceuticals

View the original press release on ACCESS Newswire

FAQ

What is the current status of MIRA's Ketamir-2 clinical trials?

Ketamir-2 has completed its second dosing cohort in Phase 1 clinical trials and is preparing for the third cohort. MIRA plans to initiate Phase IIa studies for neuropathic pain before the end of 2025.

What are the potential applications for MIRA's Ketamir-2 drug?

Ketamir-2 is being developed as a non-opioid alternative for chronic pain management, with additional potential applications in PTSD and localized inflammatory pain through a topical formulation.

What is MIRA Pharmaceuticals' acquisition target SKNY developing?

SKNY's primary candidate SKNY-1 is being developed as an oral therapeutic targeting smoking cessation and obesity, working through CB1, CB2, and MAO-B receptors.

When is MIRA participating in the BIO International Convention 2025?

MIRA will participate in the BIO International Convention 2025 from June 16-19, 2025, in Boston, MA, where it will engage in BIO One-on-One Partnering meetings.