Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the “Company” or "MindMed"), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today reported its financial results for the quarter ended March 31, 2023.
“2023 is a critical year for MindMed and we are well positioned to continue advancing our R&D pipeline toward multiple near-term milestones later this year. These include key data 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 plan to initiate the first clinical trial of MM-402 later in the year following positive preclinical results, which we plan to present at the ASCP 2023 Annual Meeting. We made great progress throughout the first quarter and continue to remain focused on long-term value creation for our shareholders through focused and efficient execution."
Phase 2b study evaluating MM-120 for generalized anxiety disorder ("GAD") remains on track for late 2023 topline readout
Phase 2a study evaluating MM-120 for attention deficit hyperactivity disorder ("ADHD") remains on track for late 2023 topline readout
Advancing development of MM-402 into first clinical trial in 2023
The Company continues to support its ongoing collaboration with the Liechti Lab at University Hospital Basel (“UHB”) in Switzerland. MindMed has exclusive worldwide rights to data, compounds and patent rights associated with UHB’s research on lysergide and other psychedelic compounds, including data from preclinical studies and investigator-initiated clinical trials.
In April 2023, Prof. Matthias Liechti and Dr. Felix Mueller, MindMed collaborators at UHB, released positive topline data from a Phase 2 double-blind investigator-initiated clinical trial evaluating two lysergide regimens in the treatment of major depressive disorder (MDD). These demonstrated the significant, rapid and beneficial effects of lysergide and its potential to safely mitigate symptoms of MDD. Patients in the high dose arm (n=28) demonstrated a least square mean change from baseline in clinician-rated Inventory of Depressive Symptomatology (IDS-C) scores of -12.9 points compared to -3.6 points in the lower dose arm (n=27, p=0.02). The statistically significant benefit as measured by IDS-C was maintained up to 16 weeks after the first administration compared to placebo (p=0.008). Data from the secondary endpoints were also encouraging. The investigational drug was generally well-tolerated, as indicated by reported adverse events, changes in vital signs and laboratory values.
Read the full press release for consolidated financial statements.
Cash Balance. As of March 31, 2023, MindMed had cash and cash equivalents totaling $129.4 million compared to $142.1 million as of December 31, 2022. The Company believes its available cash and cash equivalents will be sufficient to fund its operating requirements into the first half of 2025.
Net Cash in Operating Activities. The net cash used in operating activities was $13.3 million for the quarter ended March 31, 2023, compared to $12.9 million in the quarter ended March 31, 2022.
Research and Development (R&D). R&D expenses were $12.6 million for the quarter ended March 31, 2023, compared to $10.2 million for the quarter ended March 31, 2022, an increase of $2.4 million. The increase was primarily due to increases of $2.9 million in expenses related to clinical research for the MM-120 GAD study, $0.9 million in expenses related to our MM-402 program, and $0.2 million in internal personnel costs as a result of increasing research and development capacities, offset by a decrease of $0.7 million in expenses related to our MM-110 program, and a decrease of $0.9 million of expenses in connection with various external R&D collaborations.
General and Administrative (G&A). G&A expenses were $8.3 million for the quarter ended March 31, 2023, compared to $8.3 million for the quarter ended March 31, 2022.
Net Loss. Net loss for the quarter ended March 31, 2023 was $24.8 million, compared to $18.5 million for the same period in 2022.
MindMed management will host a conference call at 4:30 PM EST today to provide a corporate update and review the Company’s first quarter 2023 financial results. Individuals may participate in the live call via telephone by dialing (888) 396-8049 (domestic) or (416) 764-8646 (international). The webcast can be accessed live here on the Financials page in the Investors section of the MindMed website, https://mindmed.co/. The webcast will be archived on the Company’s website for at least 30 days after the conference call.
MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders.
MindMed trades on NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED.
Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release includes, but is not limited to, statements regarding anticipated upcoming milestones, trials and studies, results and timing of clinical trials, the potential benefits of the Company’s product candidates, and the Company’s cash runway funding its operations into the first half of 2025. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; lack of product revenue; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2023 under headings such as “Special Note Regarding Forward-Looking Statements,” and “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and other filings and furnishings made by the Company with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events, changes in expectations or otherwise.
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