MindMed expects big milestones in 2024

Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (Cboe Canada: MMED) announced its financial results for the year ended December 31, 2023, and provided a business update. MindMed produces no revenue at this time and reported a net loss of $95.7 million for 2023. This was a big jump over 2022’s net loss of $56.8 million.

As of December 31, 2023, MindMed said it had cash and cash equivalents totaling $99.7 million versus ending 2022 with $142.1 million. The company told investors it believes it has enough money to fund operations into 2026 if certain milestones are achieved that unlock additional capital. The net cash used in operating activities was $64.4 million, compared to $50.1 million for 2022.

“2023 was a highly productive year for MindMed, which concluded with positive Phase 2b results for MM120 in the treatment of adult patients with GAD,” said Rob Barrow, Chief Executive Officer and Director of the Company. “We believe the initial data we shared validates our scientific understanding of MM120’s mechanism of action and shows the potential to have a best-in-class product profile compared to today’s standard of care. We look forward to sharing 12-week safety, efficacy, and durability data and results from our Phase 1 pharmacokinetics bridging trial to support the advancement of our MM120 oral dissolving tablet (ODT) formulation into pivotal clinical trials at our virtual investor event in March.”

2024 is shaping up to be a busy year for MindMed.

Barrow added, “Looking further into 2024, we anticipate several additional milestones, including one-year follow-up results from an investigator-initiated clinical trial of lysergide in anxiety disorders conducted by our collaborators at University Hospital Basel. We will be working closely with the FDA to finalize our Phase 3 development program for MM120 in GAD (general anxiety disorder) and expect to hold our End-of-Phase 2 meeting with the FDA in the first half of the year. This is intended to enable the initiation of our Phase 3 clinical program in the second half of the year.”

The company said in a statement that it plans to share topline 12-week safety, efficacy, and durability results from the Phase 2b study and results from its pharmacokinetics bridging trial of the MM120 Zydis ODT formulation at an upcoming virtual investor event on March 7, 2024. MindMed expects that full results from the Phase 2b trial of MM120 in GAD will be presented at a scientific meeting in 2024.

In addition to that, MindMed plans to hold an End-of-Phase 2 meeting with the FDA in the first half of 2024 and expects to initiate its Phase 3 clinical program in the second half of 2024. Plus, one-year follow-up data from a Phase 2 placebo-controlled investigator-initiated clinical trial of lysergide in the treatment of anxiety disorders is anticipated in 2024. This trial was conducted by the company’s collaborators at University Hospital Basel (UHB) in Switzerland and completed in Q3 2023.

Board Battle

Despite winning the board battle during 2023, MindMed continues to have legal issues with those parties. The company said it filed a case against Dr. Scott Freeman and FCM MM Holdings, LLC on July 26, 2023, alleging, among other things, a breach by Dr. Freeman and FCM MM Holdings, LLC of the non-disparagement and confidentiality provisions of the Separation Agreement dated August 31, 2020, between the company and Dr. Freeman. In the filing, MindMed said, “This dispute is pending in the U.S., District Court for the District of Nevada. We are seeking permanent injunctive relief, as well as compensatory, punitive, and exemplary damages and attorneys’ fees.”

In addition to that, on September 5, 2023, MindMed filed a lawsuit in the Southern District of New York against Dr. Scott Freeman, Jake Freeman, Chad Boulanger, FCM MM Holdings, LLC, and the other three FCM nominees Farzin Farzaneh, Vivek Jain and Alexander Wodka for violations of the federal securities laws governing proxy filings, primarily Section 14(a) of the Securities Exchange Act of 1934, as amended. The company also said inits filing, “We are seeking permanent injunctive relief and attorneys’ fees, as well as an award of damages sustained by us as a result of defendants’ actions, including expenses incurred in connection with the proxy contest caused by defendants’ material misstatements and omissions.”

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