MindMed: Financial And Business Results For Q2 2022, Management And Pipeline Changes

MindMed MNMD, which recently received a letter on behalf of one of its shareholders calling for a new business strategy and offering a solution, reported its earnings for the quarter ended June 30, 2022. And the next day, it announced the appointment of two independent directors to its board.

First, a quick financial report: 

• Total cash balance of $105.7 million, expected to be sufficient for the operating requirements beyond key development milestones until 2024.

• Net cash used in operating activities was $28.0 million within six months, compared to $21.2 million for the same period in 2021. 

• R&D expenses were $9.3 million within three months, compared to $8.1 million for the three months ended June 30, 2021. The company stated it faced $2.8 million of external costs related to the LSD research program and the start of R(-)-MDMA study, while the decrease in external costs of $1.0 million was related to the completion of 18-MC study in 2021. 

• R&D expenses were $19.6 million for the six months ended June 30, 2022, compared to $14.9 million for the six months ended June 30, 2021. The company stated it faced $2.9 million of internal costs related to compensation costs for additional headcount and an increase of $1.0 million of stock-based compensation expenses.  

• Net loss within three months was $17.1 million compared to $44.5 million for the same period in 2021. 

• Net loss within the six months ended June 30, 2022 was $35.6 million compared to $58.2 million for the same period in 2021.  

Recent Highlights

MindMed’s MM-120 (LSD D-tartrate) for generalized anxiety disorder (GAD) treatment continues to be studied in patients within the Phase 2b study, of which results are expected in late 2023. Yet the company intends to prioritize further on in focusing on MM-120’s development for psychiatric indications.

MM-402 or R(-)-MDMA is a synthetic R-enantiomer of MDMA under development for treating core symptoms of autism spectrum disorder, with IND-enabling studies currently ongoing and a Phase 1 clinical trial expected to begin in 2023.

And MM-110 (zolunicant HCl or 18-MC) is MindMed’s non-hallucinogenic congener of ibogaine for the treatment of opioid withdrawal. It’s already been tested in preclinical models of withdrawal and substance use disorders, and in May 2022, the Phase 1 placebo-controlled trials showed positive results in 108 healthy volunteers. 

Now, the company intends to continue towards Phase 2 MM-110’s clinical development, yet through new, non-dilutive sources of capital, or collaborations with third parties. This means the company will temporarily halt its 18-MC (MM-110) program for opioid withdrawal, in view of the other two programs’ potentially faster path to commercialization. 

In the meeting, CEO Robert Barrow stated that after a “productive engagement” with the FDA, “it was clear that we needed to do additional nonclinical research…and therefore decided that the time and cost requirements needed to be allocated to our other programs.”

Considering Roth Capital’s reiterated buy rating -$7.00 per share- and Cantor Fitzgerald’s $3.00 target, investors are showing confidence in the company’s decision to advance with its Phase 2b trial for anxiety. 

On the other hand, in view of today’s announcement of the incorporation of Dr. Suzanne Bruhn, PhD., and Dr. Roger Crystal, M.D., Barrow expressed: “Their collective life sciences experience will be invaluable as we advance through several key product development inflection points in the coming year and we look forward to their immediate contributions to our company's success."

MindMed’s board of directors’ chair Carol Vallone reasserted both doctors’ “broad experience and strategic vision” in development and commercialization, which she expects “will serve as a valuable resource to our directors and executive leadership team as we execute our strategy to advance our brain health disorder product candidates through clinical development and potential commercialization."

Dr. Suzanne Bruhn is currently president, director and CEO of private biotech company Tiaki Therapeutics, and sits on the board of directors of Pliant Therapeutics, Travere Therapeutics and Vigil Neuroscience. She also served as president and CEO of clinical-stage companies Proclara Biosciences and Promedior Inc. 

Dr. Crystal is the president, director and CEO for Opiant Pharmaceuticals OPNT, is the lead inventor of NARCAN nasal spray, and currently sits on the board of directors of the Biotechnology Innovation Organization (BIO). He previously served as CBO for ImaginAb, a venture capital-backed biotech company, after working at Goldman Sachs, A.T. Kearney and GE Healthcare. 

Photo courtesy of Olia Danilevich on Pexels.