MIRA Pharmaceuticals Announces Ketamir-2's Oral Bioavailability Predicted to be 80%

New Data from IQVIA Supports Potential $3 Billion Annual Market

BALTIMORE, Nov. 29, 2023 /PRNewswire/ -- MIRA Pharmaceuticals, Inc. (NASDAQ: MIRA) ("MIRA" or the "Company"), an innovative pre-clinical-stage pharmaceutical company focused on neurologic diseases and neuropsychiatric disorders, today announced results from recent studies that indicate Ketamir-2's oral bioavailability is predicted to be approximately 80%.

MIRA recently unveiled its revolutionary product, Ketamir-2, which is designed to potentially reshape the landscape of depression treatment.

Ketamir-2 lead developer Adam Kaplin, MD, Ph.D., President and Chief Scientific Officer of MIRA Pharmaceuticals, commented: "Ketamir-2, an innovative analog of Ketamine developed as an oral formulation, signifies a breakthrough for Major Depressive Disorder and MDSI. 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."

Recent laboratory invitro studies of the CaCO-2 model of human intestinal drug absorption suggested Ketamir-2's superior absorption when taken by mouth compared to Ketamine, with key findings indicating a dramatic 41% net absorption (amount of drug absorbed minus the amount pumped back into the gut), signifying significantly improved uptake compared to Ketamine's -15% (where the amount of drug pumped back into the gut from the bloodstream, for eventual excretion, exceeded the amount absorbed into the body).

Given oral Ketamine's previously determined 23% bioavailability when taken by mouth, Ketamir-2's adjusted oral bioavailability based on the CaCO-2 results is predicted to be around 80%1. This bioavailability is more than double that of oral or intranasal absorption of ketamine, promising a potential shift to oral, home administration, granting patients greater autonomy, convenience, and accessibility to effective depression treatment.

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-2 could generate an average annual sales of $3 billion, with estimates rising to up to $7.8 billion. This projection highlights Ketamir-2's potential to bridge the therapeutic gap experienced by 30% of patients who do not find relief from conventional treatment-resistant depression (TRD) and major depressive disorder with suicidal ideation (MDSI) treatments, solidifying its status as a trailblazing therapeutic agent.

"This positive financial outlook bolsters our confidence in advancing Ketamir-2's clinical development," said Erez Aminov, Chief Executive Officer of MIRA Pharmaceuticals. "We are poised to make a significant impact to a market that urgently needs innovative solutions."

Annupama Kumar, MBBS, Vice President of Drug Development at MIRA Pharmaceuticals, added: "Oral delivery of Ketamir-2 could transform depression management, offering more consistent and accessible treatment for patients. This advancement is not just a milestone for MIRA Pharmaceuticals, but a beacon of hope for millions battling severe depression."

Ongoing research aims to confirm these findings and establish the safety and efficacy of Ketamir-2's oral administration.

With a keen focus on patient well-being and a robust pipeline, MIRA Pharmaceuticals is leading the way to a brighter future for individuals battling severe depression.

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 diseases 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.

About IQVIA Holdings Inc.

IQVIA Holdings Inc. is a leading global provider of advanced analytics, technology solutions, and clinical research services to the life sciences industry. The Company sought the expertise of IQVIA and commissioned them to conduct an in-depth analysis of its Ketamir-2 asset.

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.

1 Zhang K, Yao Y, Hashimoto K. Ketamine and its metabolites: Potential as novel treatments for depression. Neuropharmacology. Jan 1 2023;222:109305. doi:10.1016/j.neuropharm.2022.109305

Cision View original content:https://www.prnewswire.com/news-releases/mira-pharmaceuticals-announces-ketamir-2s-oral-bioavailability-predicted-to-be-80-302000249.html

SOURCE MIRA Pharmaceuticals, Inc.