Mind Medicine: Two Pathways Created From One Pipeline Clinical Candidate

seekingalpha11-05

Mind Medicine (MindMed) Inc. is advancing MM-120 for GAD with two phase 3 trials, VOYAGE and PANORAMA, starting in late 2024 and early 2025.MM-120 is also being tested for MDD in the phase 3 EMERGE ...

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AndreyPopov/iStock via Getty Images  The last time I wrote about Mind Medicine (MindMed) Inc. (NASDAQ:MNMD) was in a Seeking Alpha article entitled “MindMed: Despite MDMA Setback, Still Hope In Light Of Differentiating Factors.” In this article, I noted that the company had met the primary endpoint of the phase 2b MMED008 study using MM-120 for the treatment of patients with generalized anxiety disorder [GAD]. There have been two important updates since then in relation to the development of MM-120. The first development is that about several weeks after this article, the company held a productive meeting with the FDA. It noted that there was an alignment on what the phase 3 trial design should entail to be sufficient for possible regulatory approval. Having said that, the company remains on track to initiate two phase 3 studies using MM-120 for the treatment of patients with GAD in the 2nd half of 2024 and 1st half of 2025 respectively. This would put top-line results from Part A of VOYAGE in the 1st half of 2026 and then PANORAMA in the 2nd half of 2026. Another development that came about from this company is that it believe lysergic acid diethylamide [LSD] D-tartrate may also be useful in treating patients with Major Depressive Disorder [MDD]. With that said, the company only intends to initiate one of the two phase 3 studies expected for this program in the 1st half of 2025, with data from Part A for it to be released 2nd half of 2026. This registration trial is to be known as EMERGE and only if positive data is obtained for it, will the company initiate the other one. Plus, it depends upon what feedback is given by the FDA for this MDD treatment program. With several milestones anticipated for the MM-120 program targeting patients with GAD and MDD, plus the continued development of phase 1 candidate MM-402 for the treatment of patients with Autism Spectrum Disorder [ASD], I believe that investors could benefit with any potential gains made here. MM-120 Program Advancement For Another Mental Health Disorder A good thing about Mind Medicine is that its lysergic acid diethylamide [LSD] D-tartrate drug may potentially be used to target another mental health disorder, known as Major Depressive Disorder, or MDD. As I noted briefly above, the goal for it is to initiate the phase 3 EMERGE study first, to see if the drug can succeed in a trial of this caliber. Before going over this late-stage study, plus any catalysts to come out of this program, it is first important to understand what this disorder is and what the possible market opportunity for it could be. Major Depressive Disorder [MDD] is a mood disorder that causes a person to feel consistently depressed or low all the time. This is a terrible disorder for patients to have. Not only because it affects how they feel, but it also can have an impact on other essential functions for a person. Such functions also affected by MDD include the following:  Sleep pattern Appetite  Ability to think clearly.  It is normal for a person to feel sad after a life event has occurred. However, with MDD, this clinical depression persists for an extended period of time [2 weeks or more]. The global major depressive disorder treatment market is expected to reach $14.96 billion by 2032. This is a massive market opportunity. Thus, this provides another shot on goal for Mind Medicine, beyond that of going after the Generalized Anxiety Disorder [GAD] treatment market. To see if the company will be able to target these patients with MDD, it is first only going to start off with the phase 3 EMERGE study. Why is that? That's because the goal is to first see if clinical data from this study is adequate to initiate another late-stage one targeting the very same patients. Secondly, regarding the advancement of this MDD treatment program, there needs to be additional talks with the FDA about such a second trial. Having said that, the phase 3 EMERGE study is expected to start in the 1st half of 2025, with top-line data readout of Part A to be released in the 2n half of 2026. The phase 3 EMERGE 12-week, randomized, double-blind, placebo-controlled trial is expected to be broken up into two parts. Part A being the 12-week placebo-controlled portion and then Part B being the 40-week extension portion of it. It is expected that a total of 140 patients with MDD are to be randomized 1:1 to receive one of the following doses:  100 micrograms of MM-120  Placebo.  The primary endpoint is expected to evaluate the change from baseline in the Montgomery Asberg Depression Rating Scale [MADRS] score at 6-weeks between MM-120 ODT and placebo. Regarding this primary efficacy measure, it is critical because it is used to measure the severity of depression symptoms. There are point ranges from “0” to “60,” which indicates the level of depression. If the patient achieves any score at or above 35, then it signifies that they have severe depression. MM-120 For Patients With GAD Moves Towards Phase 3 After FDA Meeting As I noted above, Mind Medicine had a very productive meeting with the FDA. Matter of fact, there was an alignment on what the trial design for this GAD program should look like. To see if MM-120 oral disintegrating tablet [ODT] will be capable of being effective in treating patients with GAD, the company is expected to have two studies for this program. These pivotal late-stage studies are to be known as VOYAGE and PANORAMA. The phase 3 VOYAGE study is expected to use MM-120 ODT tablets for patients and see if it performs better than placebo. Not only that, but it's important to highlight that this study will be split into different parts [just like the other one]. The study is expected to have two portions of patients enrolled, as follows:  Part A portion of study : 12-week randomized, double-blind, placebo-controlled trial evaluating MM-120 versus placebo  Part B portion of study : 40-weeks extension study for eligible patients who meet re-treatment criteria [Open-label].  Going to Part A of this late-stage VOYAGE study, it is expected that a total of 200 patients are to be randomized 1:1 to receive either 100 micrograms of MM-120 or placebo. The primary endpoint will be a change from baseline in Hamilton Anxiety Rating Scale [HAM-A] score at Week 12 between drug and placebo. Why this specific efficacy endpoint, though? That's because this specific score is used to measure the severity of anxiety. The end game goal is to reduce a significant number of points change from baseline of the drug compared to placebo. The score ranges from “0” to “56” to determine such severity. The higher the score that is given for the patient, the worse anxiety or worry that they have. Thus, with statistical significance achieved here, then it would only be one piece of the puzzle. The rest is the second phase 3 PANORAMA study. The phase 3 VOYAGE study is expected to start any day now in the 2nd half of 2024, with top-line readout of Part A results expected in the 1st half of 2026. Then, the PANORAMA study is expected to kick off in the 1st half of 2025, with possible data [also from Part A of it] expected in the 2nd half of 2026. GAD is a devastating disease and there needs to be a new treatment option for this indication. Why is that? Well, consider that the last FDA approval for these patients was in 2007. It remains to be seen if MM-120 does well in treating these GAD patients, but the fact that it was able to achieve the primary and secondary endpoints of this study bodes well for the pivotal one. At week 4 patients given 100 micrograms of MM-120 achieved a 65% clinical response rate, and then at Week 12 the response rate was 48%. Financials According to the 10-Q SEC Filing, Mind Medicine had cash and cash equivalents of $243.1 million as of June 30th of 2024. This was not going to be enough funds to operate its business. Thus, it chose to enact a cash raise. This was the pricing of a public offering on August 9th of 2024 to raise approximately $75 million in funds. This cash raise, along with prior cash on hand, is expected to fund its operations, or be a cash runway, into 2027. The company is expected to offer a financial and corporate update on November 7th of 2024. I wouldn't expect the cash runway projection to change much, especially in light of the guidance that was given for it, which is that it would have enough to operate its business into 2027. What investors might want to watch out for as a change with the next earnings report could possibly be the catalyst dates I noted above being altered. Although, it is quite possible that there may not be any changes to these catalysts at all. The company's cash burn is roughly $24.5 million in cash per quarter. This is broken down into $14.7 million in R&D expenses and then $9.8 million in G&A expenses. Risks To Business There are several risks that investors should be aware of before investing in Mind Medicine. The first risk to consider would be regarding the development of MM-120 for the treatment of patients with GAD in the two expected phase 3 studies, which will be VOYAGE and PANORAMA. Even though this drug was shown to do well in the prior phase 2b study in GAD patients, as I noted above with 4-week and 12-week response rates of 65% and 48% respectively, there is no assurance that these or higher percentage response rates will be achieved in either of these pivotal phase 3 studies to be done. Nor, that the final data from one or both will be enough to file for regulatory approval of MM-120 for the treatment of these patients with GAD. The second risk to consider would be in terms of the EMERGE study to be done, using MM-120 for the treatment of patients with MDD. That's because the goal is to only initiate one study first in the early part of next year. Only if positive results are achieved, will the company initiate the second pivotal one. The risk here is that there is no guarantee that the primary endpoint of the EMERGE study will be met with statistical significance. Nor, that the FDA is going to feel comfortable enough to allow the company to initiate the second pivotal phase 3 study using MM-120 for the treatment of these patients. The third and final risk to consider would be in terms of the development of MM-402, which is being evaluated in the ongoing phase 1, single-ascending dose study in healthy volunteers. The goal of this study is to assess the effects of giving this drug on repeated daily doses, in hopes of helping to treat their Autism Spectrum Disorder [ASD]. The risk here is that there is no assurance that the final data will show the allowance of daily dosing of MM-402 for these patients. Nor, that the clinical data to be released from it will be enough to eventually move towards a phase2 study. Conclusion Mind Medicine has done well to develop MM-120 for two massive, multibillion-dollar market indications. The most notable program from its pipeline would be the use of this drug for the treatment of patients with GAD. The reason I state that is because it had a highly productive end-of-phase 2 [EOP2] meeting with the FDA regarding being able to advance MM-120 in two pivotal phase 3 studies for the treatment of these patients with GAD. With both the VOYAGE and PANORAMA studies expected to start within a 1-year period, this sets up two data readouts in 2026. It remains to be seen if the data from Part A of these two pivotal studies is positive, but it sets up milestones for investors to look forward to. Plus, this is only on the front of developing MM-120 for the treatment of patients with GAD only. There is a shot at targeting the MDD patient population, which is expected to be a huge market opportunity in itself. The global major depressive disorder treatment market is expected to reach $14.96 billion by 2032. MM-402 acts as another de-risking product for its pipeline, but the hope is that it will be able to progress into a phase 2 study. However, that largely depends upon if repeat dosing of this drug is possible. Along with the fact, that positive data has been obtained from the ongoing phase 1 study for it.  Editor's Note: This article discusses one or more securities that do not trade on a major U.S. exchange. 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