MindMed Has Big Goals For 2023

After the market closed on Thursday, Mind Medicine Inc. or MindMed (NASDAQ: MNMD), (NEO: MMED) reported its financial results for the full year that ended December 31, 2022. The psychedelic medicine company does not have any revenue to report at this time. MindMed reported the net loss for 2022 was $56.8 million versus $93.0 million for 2021. The net loss per share was ($1.84) for 2022 versus ($3.40) in 2021. This missed the Yahoo Finance Average analyst estimate for a loss per share of ($0.52).

The company noted that it has cash and cash equivalents of $142.1 million versus $133.5 million at the end of 2021. MindMed said it believes its cash will be sufficient to fund its operating requirements into the first half of 2025.

Expenses

The net cash used in operating activities was $50.1 million for 2022. R&D expenses were $36.2 million for 2022 a bit higher than 2021’s $34.8 million. The company attributed the increase an additional $2.9 million in expenses related to clinical research for MM-120, and $5.4 million in internal personnel costs as a result of increasing research and development capacities, offset by a decrease of $5.6 million in expenses related to the company’s MM-110 program, and a decrease of $2.4 million of expenses in connection with various external R&D collaborations.

G&A expenses were $30.2 million for 2022 versus $59.1 million for 2021, a decrease of $28.9 million. The company said that the decrease was primarily due to a decrease of $27.4 million in non-cash stock-based compensation expenses primarily relating to the modification of stock option awards and RSUs recorded during the year ended December 31, 2021.

“Our significant progress in 2022 has set the stage for what we expect to be a transformational 2023,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “This year we expect key data readouts from our Phase 2b study of MM-120 for the treatment of generalized anxiety disorder, as well as from our Phase 2a proof-of-concept trial of repeated low-dose MM-120 in attention-deficit/hyperactivity disorder. Additionally, we expect to initiate the first clinical trial of MM-402 later in the year. Importantly, we believe our financial position provides us with the ability to fund our programs well beyond these key milestones and into the first half of 2025. I am incredibly proud of our team’s achievements, and I am more confident than ever in our ability to continue advancing our organization and development programs. We are keenly focused on our mission to deliver novel therapies to treat brain health disorders, which we believe will lead to meaningful improvements in patient outcomes in these major areas of unmet medical need.”

R&D 2023

MindMed has big plans for 2023. The company outlined its progress for various study trials in a statement as follows:

Phase 2b study evaluating MM-120 for generalized anxiety disorder  remains on track

• MM-120, the company’s proprietary, pharmaceutically optimized form of lysergide D-tartrate, is being developed for the treatment of GAD. In August 2022, the Company initiated dosing in the 200-patient Phase 2b dose-optimization study of MM-120 for the treatment of GAD. Patient enrollment is currently ongoing, and the study remains on track, with topline results expected to be announced in late 2023.

Phase 2a study evaluating MM-120 for attention deficit hyperactivity disorder remains on track

• The company’s Phase 2a proof-of-concept trial for the treatment of ADHD is designed to assess the safety and efficacy of repeated low-dose MM-120 administration in 52 patients. The company expects topline results in late 2023.

Advancing the development of MM-402 into the first clinical trial in 2023

• The company is developing MM-402, the company’s proprietary form of the R-enantiomer of 3,4-Methylenedioxymethamphetamine (“MDMA”), for the treatment of core symptoms of autism spectrum disorder (“ASD”). Results from a preclinical study of MM-402 in a model of ASD are expected to be presented in the first half of 2023.

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