MindMed Moves Along In LSD, MDMA Studies

After the market closed on Thursday, Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) reported its financial results for the quarter ending June 30, 2022. At this time the company has no revenue and reported a net loss of $17.1 million versus $44.5 million for the same period in 2021.

“In the second quarter, we took important steps to advance our ongoing development programs, which was highlighted by the progression of our Phase 2b dose-optimization trial of MM-120 for the treatment of generalized anxiety disorder (GAD), one of the largest well-controlled studies of LSD ever conducted. This trial builds on encouraging positive data generated in the LSD-Assist Study, a Phase 2 placebo-controlled investigator-initiated clinical trial of LSD in the treatment of anxiety disorders and decades of evidence of the therapeutic potential of LSD in anxiety, depression, and beyond. During the quarter, we also announced positive safety and tolerability results for our MM-110 program, for the treatment of opioid withdrawal, that provide important insight into the design for future studies for the clinical program for individuals undergoing supervised opioid withdrawal,” said Robert Barrow, Chief Executive Officer and Director of MindMed.

The MM-120 (LSD D-tartrate) is a proprietary, pharmaceutically optimized form of lysergic acid diethylamide (LSD) that is primarily being developed for the treatment of generalized anxiety disorder (GAD). The company said it remains on track for patient dosing in the Phase 2b dose-optimization study of MM-120 for the treatment of GAD, with topline results expected in late 2023.

The MM-402 or R(-)-MDMA is  a synthetic R-enantiomer of 3,4-Methylenedioxymethamphetamine that the company is developing for the treatment of core symptoms of autism spectrum disorder. The IND-enabling studies are currently ongoing and initiation of the Phase 1 clinical trial of MM-402 is planned for 2023. Through the company’s collaboration with the University Hospital Basel in Switzerland, a Phase 1 pharmacokinetic/pharmacodynamic investigator-initiated trial of R(-)-MDMA, S(+)-MDMA and (+)- MDMA in healthy volunteers is expected to commence in Q3 2022.

Expenses

Research and development expenses were $9.3 million for the quarter versus $8.1 million for the same time period in 2021, an increase of $1.2 million. MindMed said the increase was primarily due to $2.8 million of external costs related to the LSD research program and the commencement of R(-)-MDMA study. G&A expenses were $7.6 million for the quarter versus $37.1 million for last year’s second quarter, a decrease of $29.5 million. The decrease was primarily due to $24.4 million in additional non-cash stock-based compensation expenses relating to the modification of stock option awards and RSUs.

MindMed said it had cash and cash equivalents totaling $105.7 million compared to $133.5 million as of December 31, 2021. MindMed believes its available cash and cash equivalents will be sufficient to meet its operating requirements beyond its key development milestones in 2023 and into 2024.

“As we continue to sharpen our efforts on our key strategic priorities for the near-term, we remain primarily focused on directing our resources towards advancing our MM-120 program in psychiatric indications, and our MM-402 program in autism spectrum disorder. We intend to continue further development for our MM-110 program subject to successful pursuit of non-dilutive sources of capital and/or collaborations with third parties. We believe that this strategy represents a cost-effective approach to advancing the programs in our pipeline that we believe have the highest probability to generate near-term value for our shareholders. With our sharpened focus and strengthened leadership team, we look forward to providing additional updates on our progress as we advance our clinical pipeline.”

Separately, Schond L. Greenway was appointed as Chief Financial Officer in May. On August 4, 2022, the Board of Directors approved a ratio of the 1-for-15 reverse share split of the Company’s common shares. The reverse share split is expected to take effect after the close of business on August 26, 2022, with trading expected to begin on a split-adjusted basis on the Nasdaq and the Neo Exchange Inc. at market open on August 29, 2022.

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