The Albany Gazette - MIRA Pharmaceuticals Closes Acquisition of SKNY Pharmaceuticals, Expands Pipeline with SKNY-1 for Obesity and Nicotine Addiction

Closing adds $5 million in marketable securities, strengthens financial position, and complements MIRA's advancing programs including Ketamir-2 and MIRA-55

MIAMI, FLORIDA / ACCESS Newswire / September 30, 2025 / MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) ("MIRA" or the "Company"), a clinical-stage pharmaceutical company focused on developing novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders, today announced that it has completed its acquisition of SKNY Pharmaceuticals, Inc. ("SKNY").

As part of the transaction, SKNY fulfilled all closing obligations, contributing $5 million in marketable securities to MIRA, further strengthening the Company's balance sheet.

"The successful closing of the SKNY acquisition marks a pivotal milestone for MIRA, both financially and strategically," said Erez Aminov, CEO of MIRA. "We are expanding our pipeline into obesity and nicotine addiction with SKNY-1, while continuing to advance Ketamir-2 through clinical development and progressing MIRA-55 as a novel approach to inflammatory and nociceptive pain. Together, these programs position MIRA to address major unmet needs across some of the largest healthcare markets."

SKNY-1: A Next-Generation Oral Therapy Candidate for Obesity and Smoking Cessation

SKNY-1 is a differentiated oral drug candidate designed to modulate CB1, CB2, and MAO-B pathways to address energy storage, lipid metabolism, appetite, cravings, and reward - without the psychiatric side effects that limited earlier CB1-targeting drugs.

Key preclinical findings include:

• Up to 30% reduction in body weight without muscle loss in validated animal models.

• Marked modification of metabolic parameters.

• Reversal of nicotine craving and high-calorie food cravings, supporting dual therapeutic potential.

• Favorable CNS safety profile compared with prior CB1-targeting agents.

Dr. Itzchak Angel, Chief Scientific Advisor at MIRA, commented:

"SKNY-1's unique biased CB1 signaling and favorable CB2/MAO-B activity translate into robust and broad-spectrum efficacy across metabolic syndrome, obesity, and addiction models while addressing the safety limitations of earlier agents. We believe it has the potential to be best-in-class."

Ketamir-2: Clinical-Stage Development in Neuropathic Pain

On September 22, 2025, MIRA announced favorable topline results from the single ascending dose (SAD) portion of its ongoing Phase 1 clinical trial of Ketamir-2, its proprietary next-generation ketamine analog. The study demonstrated Ketamir-2 was safe and well tolerated across all dose levels, with predictable absorption, once-daily dosing potential, and no CNS side effects typically associated with ketamine.

Preclinical studies further support Ketamir-2's potential in neuropathic pain, depression, and PTSD, reinforcing its profile as a differentiated non-scheduled therapeutic.

MIRA-55: A Novel Approach to Inflammatory Pain

MIRA-55, the Company's oral pharmaceutical cannabis-derived candidate, has shown preclinical results in inflammatory and nociceptive pain comparable to morphine. Unlike opioids, MIRA-55 is designed to provide pain relief without addictive risk, positioning it as a promising next-generation analgesic.

Market Opportunity

Obesity, metabolic disorders, nicotine addiction, neuropathic pain, nociceptive and inflammatory pain, depression, and post-traumatic stress disorder (PTSD) represent some of the largest and fastest-growing healthcare markets, each with high prevalence and substantial unmet medical need.

MIRA is directly addressing these areas through its pipeline:

• SKNY-1 for obesity and nicotine addiction.

• Ketamir-2 for neuropathic pain with potential in depression and PTSD.

• MIRA-55 for inflammatory and nociceptive pain.

• Additional preclinical programs targeting cognitive impairment and related neuropsychiatric disorders.

Together, these programs underscore MIRA's strategy of advancing differentiated, non-opioid, and non-addictive therapeutic options aimed at improving patient outcomes in high-value markets.

About MIRA Pharmaceuticals, Inc.

MIRA Pharmaceuticals, Inc. (NASDAQ:MIRA) is a clinical-stage pharmaceutical company focused on the development and commercialization of novel therapeutics for neurologic, neuropsychiatric, and metabolic disorders. The Company's pipeline includes oral drug candidates designed to address significant unmet medical needs in neuropathic pain, inflammatory pain, obesity, addiction, anxiety, and cognitive decline.

For more information, please visit www.mirapharmaceuticals.com.

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 the Form 14A filed by MIRA on June 18, 2025, and other SEC filings, which are on file with the SEC at www.sec.gov and on 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:
Helga Moya
[email protected]
(786) 432-9792

SOURCE: MIRA Pharmaceuticals

View the original press release on ACCESS Newswire

(F.Allen--TAG)