Release Date: August 13, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Mind Medicine Inc (MNMD, Financial) successfully completed a constructive end-of-phase 2 meeting with the FDA, supporting the advancement of MM120 into pivotal Phase 3 clinical trials for generalized anxiety disorder (GAD).
- The company is on track to initiate its first Phase 3 trial for MM120 ODT in GAD in the second half of 2024, marking a major milestone in their development program.
- Mind Medicine Inc (MNMD) announced the expansion of their R&D program for MM120 into major depressive disorder (MDD), with the initiation of the Emerge Study expected in the first half of 2025.
- The company raised approximately $75 million in a successful underwritten public offering, extending their cash runway into 2027 and at least 12 months beyond their first Phase 3 clinical readout in GAD.
- MM120 has shown significant potential in addressing large unmet needs in brain health disorders, with Phase 2b trial results demonstrating an effect size more than double that of the standard of care and a 48% remission rate 12 weeks after a single dose.
Negative Points
- Research and development expenses were $14.7 million for the quarter ended June 30, 2024, representing a slight decrease from the same period in 2023, but still indicating high ongoing costs.
- General and administrative expenses were $9.8 million for the quarter ended June 30, 2024, a decrease from the same period in 2023, but still a significant expenditure.
- The company's net loss for the quarter ended June 30, 2024, was $5.9 million, although this was an improvement from the $29.1 million loss in the same period in 2023.
- There are risks associated with the forward-looking statements made during the call, including potential changes in market conditions and difficulties with research and development and regulatory approval processes.
- The company must carefully balance the scope and sequencing of their clinical programs to maintain their cash runway into 2027, which could limit the pace of their development efforts.
Q & A Highlights
Q: For the first question, is the open label 100 microgram dose to help maintain response or remission rates versus having patients continue the 50-microgram dose in the 40-week follow-up? And for my second question, is for reduction of the treatment session duration to 8 hours from 12 hours, what information enabled this decision to be agreed by the FDA and what requirements for patient care following the 8-hour treatment session, what requirements will be implemented?
A: The 100 microgram dose is the clinical dose of interest based on Phase 2b results, while the 50-microgram dose is used as a functional mask to address functional unblinding. For the reduction in treatment session duration, data from Phase 2b showed that shorter monitoring times were feasible, and structured criteria were used to determine the appropriate timing for ending sessions.
Q: How much dose dependence will you need to demonstrate between 50 and 100 micrograms in order to address the potential regulatory questions about functional unblinding? Do you need to show a statistical separation between those two arms or just a trend?
A: The 50-microgram control is there as a functional mask and not of statistical interest. The primary analysis of the Phase 2 study established dose response with high statistical significance. The 100 microgram dose is the go-forward dose, and the 50-microgram dose is included to confound patient expectancy.
Q: Regarding the regulatory pathway in GAD, did you confirm with the FDA that the Phase 2b can be used as one of the pivotal trials or do you still need both Phase 3 trials to file NDA? And quickly, just a follow-up to Brian's question. With the first Phase 3 GAD starting in the second half of the year, what will be the rate limiting step for filing considering the 40-week open label retention trial?
A: The Phase 2b study is not a pivotal study. We intend to file with two Phase 3 studies, Voyage and Panorama. The rate limiting factor will be the completion of Part A of these studies to demonstrate safety and efficacy.
Q: Could you talk a little bit more about the end-of-phase 2 meeting, especially considering the Lykos AdCom, whether there were any issues or concerns that were raised during the meeting?
A: The end-of-phase 2 meeting was constructive with no surprises. We integrated feedback from the Lykos AdCom into our discussions with the FDA, and we came away with a high degree of alignment on our Phase 3 program.
Q: Do you have any specific targets for prior use of LSD or other psychedelic inclusion criteria in your Phase 3 trials? And in the open-label portions of your studies, how do you ensure integrity is maintained to make sure that any potential durability of effect is more purely attributable to MM120 versus other treatments or therapy?
A: We have explicit exclusion criteria related to recent use and heavy use of psychedelics. In the open-label extension phase, we enforce restrictions on outside treatments to ensure that any observed effects are attributable to MM120.
Q: In terms of 120, I know your primary focus is the domestic market, but have you started at all analyzing ex-US opportunities? And if so, how would you characterize that analysis?
A: We have started analyzing ex-US markets and are open to collaborations and partnerships for commercialization outside the US. However, our primary focus remains on the US market.
Q: The dose relationship being -- going after 50 microgram and 100 micrograms. Does the FDA generally agree with that approach that's demonstrating a dose relationship just address the expectancy bias or functional blinding issue?
A: We presented our view and strategy to the FDA and are confident in our path forward. The 50-microgram dose is included to mitigate expectancy bias and functional unblinding, which is a common issue in psychiatry.
Q: For the reduction of the treatment session duration to 8 hours from 12 hours, what information enabled this decision to be agreed by the FDA and what requirements for patient care following the 8-hour treatment session will be implemented?
A: Data from Phase 2b showed that shorter monitoring times were feasible. We used structured criteria to determine the appropriate timing for ending sessions and presented this data to the FDA. In Phase 3, the minimum required monitoring duration will be 8 hours, with assessments starting as early as 5 hours.
Q: How do you ensure integrity is maintained in the open-label portions of your studies to make sure that any potential durability of effect is more purely attributable to MM120 versus other treatments or therapy?
A: We enforce restrictions on outside treatments and ensure that the only new or changed treatment during the extension phase is MM120. This approach maintains the integrity of the data and ensures that observed effects are attributable to MM120.
Q: Could you talk a little bit more about the end-of-phase 2 meeting, especially considering the Lykos AdCom, whether there were any issues or concerns that were raised during the meeting?
A: The end-of-phase 2 meeting was constructive with no surprises. We integrated feedback from the Lykos AdCom into our discussions with the FDA, and we came away with a high degree of alignment on our Phase 3 program.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
