MIRA Pharmaceuticals, 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).

"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."