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With Mira-55 and Ketamir-2, MIRA is advancing complementary non-opioid therapies for two of the largest pain markets

MIAMI, FLORIDA / / July 3, 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 positive preclinical data demonstrating that Mira-55, the Company's proprietary non-psychotropic marijuana analog, delivered morphine-comparable pain relief in a validated model of inflammatory pain-without causing local inflammation.

Mira-55 is a next-generation analog of marijuana, engineered to selectively activate CB2 cannabinoid receptors, which are associated with anti-inflammatory and analgesic effects. Unlike THC, Mira-55 minimizes activation of CB1 receptors, reducing the risk of euphoria, sedation, and pro-inflammatory side effects.

"These results reinforce the value of Mira-55 as a differentiated cannabinoid-based therapy with real clinical potential," said Erez Aminov, Chairman and CEO of MIRA. "We believe the drug's ability to match morphine's pain relief-without the baggage of addiction, sedation, or THC-like effects-makes Mira-55 an ideal candidate for large, underserved inflammatory pain markets. It's another step in building a non-opioid pain franchise that addresses both inflammatory and neuropathic pain."

Study Overview and Key Findings

Mira-55 was tested using the formalin model, a gold-standard preclinical method for studying inflammatory pain. In this model, formalin is injected into the rat's paw, producing a pain response that mimics human inflammatory pain. Pain sensitivity was assessed using Von Frey Filament testing, which measures tactile pain thresholds, and inflammation was measured by paw edema volume.

Key findings:

• Mira-55 reduced pain sensitivity by approximately threefold, restoring thresholds to near-baseline levels.

• Its analgesic effect was equivalent to morphine, the standard opioid comparator in the study.

• No sedation or inflammatory swelling was observed with Mira-55 treatment.

Importantly, following a scientific review, the U.S. Drug Enforcement Administration (DEA) determined that Mira-55 is not classified as a controlled substance. This designation supports the compound's long-term clinical and commercial viability and removes key barriers typically associated with cannabinoid-based drug development.

These results build on prior data from a separate inflammatory pain model conducted by a leading U.S. academic research center, where Mira-55 blocked both thermal and mechanical hyperalgesia without increasing inflammation. In contrast, low-dose THC in that model exacerbated inflammation-further validating Mira-55's selective pharmacological profile.

"Mira-55 offers the pain-relieving potential of cannabinoids without the liabilities traditionally seen in THC-based drugs," said Dr. Itzchak Angel, Chief Scientific Advisor at MIRA. "Its novel structure and unique profile with CB2 selectivity and non-scheduled DEA status make it a compelling candidate for treating inflammation-driven pain conditions that are poorly managed by today's standards."

Strategic Fit Within MIRA's Pain Portfolio

Mira-55 complements Ketamir-2, MIRA's clinical-stage NMDA receptor antagonist, which is advancing through Phase 1 development for neuropathic pain. While Ketamir-2 addresses nerve-related pain through central mechanisms, Mira-55 targets inflammatory pain through the endocannabinoid system. Together, they represent two mechanistically distinct, non-opioid approaches to treating chronic pain.

"With Mira-55 and Ketamir-2, we now have two highly differentiated drug candidates with the potential to transform how inflammatory and neuropathic conditions are treated," added Aminov. "We're advancing each asset methodically, and we're energized by the momentum we've built across the pipeline."

Corporate Update on SKNY Merger

MIRA also announced continued progress on its previously disclosed acquisition of SKNY Pharmaceuticals, the developer of SKNY-1, a novel investigational therapy targeting both obesity and nicotine addiction. In recent studies, SKNY-1 demonstrated a 30% reduction in body weight without muscle loss, along with a reversal of nicotine cravings-highlighting its potential as a differentiated treatment in two major markets. The U.S. Securities and Exchange Commission (SEC) has completed its review of the merger proxy with no comments, allowing MIRA to proceed with shareholder approval and the final steps toward completing the transaction.

"We are pleased to report that the SEC had no comments on our merger filing, which reflects the quality of our regulatory and business preparation," said Aminov. "This milestone allows us to advance toward shareholder approval with clarity and confidence as we prepare for the next phase of growth."

Next Steps

MIRA Pharmaceuticals is advancing Mira-55 toward an Investigational New Drug (IND) submission, with ongoing activities supporting future clinical development in inflammatory pain. The Company remains focused on progressing both lead programs-Mira-55 and Ketamir-2-toward their next regulatory and clinical milestones.

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 areas such as neuropathic pain, inflammatory pain, obesity, addiction, anxiety, and cognitive decline.

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 and on MIRA's website at . 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