Mind Medicine (MindMed) Inc. (Nasdaq: MNMD), (NEO: MMED) reported its financial results for the second quarter ending on June 30. The company has no revenue to report at this time, but the net loss for the quarter increased to $29.1 million versus last year’s net loss of $17 million for the same period in 2022.
It did note that it had cash and cash equivalents totaling $116.9 million versus $142.1 million as of Dec. 31, 2022. MindMed said it believes it has enough money to fund its operations into the first half of 2025.
“We’re coming up on a critical period for MindMed as we are close to wrapping up enrollment in our Phase 2b study of MM-120 for the treatment of generalized anxiety disorder (GAD),” said Robert Barrow, chief executive officer and director. “Our ability to enroll a study of this size in such an efficient manner stands out in the field and speaks to the remarkable quality of our R&D team. We are also excited to have licensed Catalent’s Zydis ODT technology for use with MM-120 which we believe significantly bolsters the differentiation and protectability of our MM-120 product candidate while potentially offering enhanced bioavailability and more rapid absorption, which may lead to a shorter treatment session.”
Expenses
MindMed reported that the operating expenses were $29 million in the second quarter versus $16 million for the same time period in 2022.
Research and development expenses were $14.8 million for the quarter versus $9.3 million for the quarter in 2022, an increase of $5.5 million. The company said the increase was primarily due to increases of:
- $4.4 million in expenses related to clinical research for the MM-120, MindMed’s LSD drug, GAD study.
- $800,000 in preclinical activities
- $600,000 in internal personnel costs as a result of increasing R&D capacity
- $200,000 in connection with various external R&D collaborations
Those increases were partially offset by a decrease of $500,000 in expenses related to the MM-110 program and a decrease of $100,000 related to the MM-402 program.
Post Board Battle
MindMed is coming off a bruising battle for control of the company. Last month, shareholders voted for the board members who wanted to pursue more research at the Phase II level for MM-120, while a group called FCM MM Holdings fought for a faster track to a Phase III study.
The company said that a topline readout of MM-120 in GAD (Phase 2b) is expected in the fourth quarter of 2023 with enrollment to be concluded in the third quarter of 2023.
“It is our aim that with compelling clinical data from our Phase IIb study, our proprietary form of LSD MM-12 will become one of the leading candidates, if not the leading candidate, in the psychedelic drug class,” Barrow said on the company’s latest earnings call.
He went on to say that the Phase 2b study of MM-120 and GAD is the largest controlled study of LSD ever conducted and will guide the dose selection and development strategy for MM-120. However, he also noted that the patient population size was reduced from 200 to 180.
In addition, MindMed entered into an exclusive license agreement with Catalent that covers all forms of LSD across all major pharmaceutical markets.
“With our agreement, RyMed has gained access to Catalent-patented Zydis orally disintegrating tablets, or ODT, technology for use with MM-120,” Barrow said.
“We are also encouraged by the recent growth and uptake of Janssen’s Spravato nasal spray, which similarly utilizes a session-based delivery paradigm to the lack of a durable treatment response for Spravato requires patients to spend over 12 hours in the clinical study across six or more visits in the first month of treatment alone,” Barrow added.
In the most recent quarter, Spravato sales grew 99% year-over-year with a greater than $675 million annual run rate, which the company believes will translate into willingness to adopt MM-120 – “should we be successful in demonstrating the safety and effectiveness” – with its “more durable and less administratively commerce delivery characteristics.” (Full Story)