• Announces Research Collaboration with Pharmaseed to Conduct Pre-Clinical Studies on the Use of Ketamir for Patients with Major Depressive Disorder (MDD) and Post-Traumatic Stress Disorder (PTSD)
• Studies will Investigate Antidepressant Properties of Ketamir to Position for Initial IND Application in 2024

BALTIMORE, Feb. 5, 2024 /PRNewswire/ -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), an innovative pre-clinical-stage pharmaceutical company focused on the treatment of neurologic and neuropsychiatric disorders, today provided a corporate and operational update.

The Company has partnered with Pharmaseed Ltd., a clinical research organization ("CRO"), to research and evaluate Ketamir-2 ("Ketamir"), a novel ketamine analog with improved gastrointestinal bioavailability under investigation to potentially be an orally delivered ultra-rapid antidepressant.

Pharmaseed is Israel's largest GLP-certified pre-clinical and early clinical CRO specializing in translational and regenerative studies. The MIRA team will utilize Pharmaseed's neurological disorder expertise to conduct pre-clinical research on Ketamir, focusing primarily on investigating its antidepressant properties. The studies will include safety and efficacy evaluation in various animal models. Additionally, MIRA has initiated a Toxicology program for Ketamir in collaboration with Frontage Laboratories. The Company anticipates positioning Ketamir for an initial Investigational New Drug (IND) application with the FDA by the end of 2024.

Ketamir is a novel compound designed to address the challenges presented by major depressive disorder (MDD), a significant health concern affecting approximately 18 million people in the U.S., of which 5.5 million reported suicide ideation (MDSI)¹. Tailored for convenient home use, it offers administration ease and aims for fewer side effects, eliminating the need for clinical supervision associated with existing treatments like Spravato. The total annual burden of medication-treated MDD among the US population was $92.7 billion, with $43.8 billion (47.2%) attributable to Treatment Resistant Depression (TRD)².

Moreover, Ketamir is also under investigation for treating Post Traumatic Stress Disorder (PTSD), a market that is projected to reach $26 billion by 2031³. Ketamir aims to serve as an alternative to commonly prescribed drugs for PTSD including SSRIs such as Sertraline (Zoloft), Paroxetine (Paxil), as well as SNRIs such as Venlafaxine (Effexor).

Additionally, a valuation analysis conducted by IQVIA, a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry, forecasts that by 2035, Ketamir could generate average annual sales of $3 billion, with estimates rising to up to $7.8 billion⁴.

"We are privileged to be working with Pharmaseed to evaluate our novel ketamine analog that may have the potential to transform the treatment of depression and PTSD," said Erez Aminov, Chief Executive Officer of MIRA Pharmaceuticals. "Pharmaseed is an ideal pre-clinical research partner with their experience in a wide range of neurological disorders including depression and anxiety. Results from recent studies indicate Ketamir's oral bioavailability is predicted to be approximately 80%, and this ongoing research aims to confirm these findings and establish the safety and efficacy of Ketamir's oral administration. We believe the pre-clinical program and toxicology work will prepare us for an IND application investigating Ketamir for the treatment of TRD, MDSI, and PTSD in late 2024, with a Phase I trial expected to begin post-IND submission. With a growing need for a rapid-acting antidepressant that can assist patients with TRD, MDSI, and PTSD and strong market potential, we look forward to the results from the partnership with Pharmaseed."

Itschak Lamensdorf, PhD, Founder and CEO of Pharmaseed, added, "We're enthusiastic about joining forces with MIRA to develop their groundbreaking pipeline for CNS disorders, a field with critical unmet needs. At Pharmaseed, leveraging our expertise to transition ideas into early clinical stages is fundamental to our mission, and this collaboration is a testament to that commitment."

New Research Coverage

MIRA is honored to announce that Kingswood Capital Partners, LLC, a respected and reputable entity in the financial sector, has initiated research coverage on the Company's publicly traded stock with a Buy rating and a $10 Price Target. For more information, please contact your Kingswood Capital Partners, LLC representative.

About Pharmaseed Ltd.

Pharmaseed is a GLP-certified contract research organization (CRO) providing pre-clinical, early clinical and consulting services for medical device, biotechnology and pharmaceutical companies. Pharmaseed also provides pre-formulation services for small and medium-size start-up companies as well as companies in the idea and feasibility stages. For more information, visit https://www.pharmaseedltd.com/.

About Kingswood Capital Partners, LLC

Kingswood Capital Partners, LLC, part of the Kingswood Group, is a network of wealth management firms that includes an SEC-registered RIA and a FINRA-licensed broker-dealer, offering comprehensive wealth management and business-building services, designed specifically for the independent financial advisor.

¹ BMC Psychiatry, PMID: 32703173

² The Journal of Clinical Psychiatry, PMID: 33989464

³ Allied Market Research: Post-Traumatic Stress Disorder Treatment Market Research, 2031

⁴ IQVIA Analysis

About MIRA Pharmaceuticals, Inc.

MIRA Pharmaceuticals, Inc. (Nasdaq: MIRA) is a pre-clinical-stage pharmaceutical development company with two neuroscience programs targeting a broad range of neurologic and neuropsychiatric disorders. The Company's novel oral pharmaceutical marijuana, MIRA1a, is currently under investigation for treating adult patients suffering from anxiety and cognitive decline, often associated with early-stage dementia. MIRA1a, if approved by the FDA, could mark a significant advancement in addressing various neuropsychiatric, inflammatory, and neurologic diseases and disorders.

MIRA has an exclusive licensing agreement for Ketamir-2, a unique, patent pending novel oral ketamine analog under investigation to potentially deliver ultra-rapid antidepressant effects, providing hope for individuals battling treatment-resistant depression (TRD) and major depressive disorder with suicidal ideation (MDSI).

The U.S. Drug Enforcement Administration (DEA)'s scientific review of MIRA1a and Ketamir-2 concluded that neither would be considered a controlled substance or listed chemical under the Controlled Substances Act (CSA) and its governing regulations.

Additional information about the Company is available at: www.mirapharmaceuticals.com.

Forward-Looking Statements

This press release may contain forward-looking statements about MIRA Pharmaceuticals, Inc. ("MIRA," "we," "us," or "our"). In some cases, you can identify forward-looking statements by terminology such as "anticipate,' "believe," "contemplate," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will" or "would," or the negative of these terms or other comparable terminology. These forward-looking statements are subject to numerous risks and uncertainties, many of which are beyond our control, including risks and uncertainties regarding our ability to develop and obtain regulatory approval for our product candidates, Ketamir-2 and MIRA1a. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, which may cause our actual results, levels of activity, performance or achievements of and those of our industry to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Some of these risks and uncertainties are identified in our Registration Statement on Form S-1 filed with the SEC (File No. 333-273024) and in our other filings with the SEC, which are available at www.sec.gov. You should not place undue reliance on any forward-looking statement. We undertake no obligation to update or revise publicly any of the forward-looking statements after the date hereof to conform the statements to actual results or changed expectations except as required by law.

General Note

This press release discusses product candidates that are in early stage pre-clinical development and have not yet been approved for marketing by the U.S. Food and Drug Administration. No representations are made as to the safety or effectiveness of these product candidates for the uses for which they are being studied. There is no assurance that either product candidate will proceed through development or will receive FDA approval for marketing.