Institutional ownership is generally a good sign, in most cases. I'm not sure that everyone would be impressed that they are the largest holding of AdvisorShares Psychedelics ETF. I do think there is a pretty good case that 1. some of the products being developed by MNMD are likely to have significant and profitable markets in the future 2. the stock has a better than average chance of increasing in price over time - perhaps dramatically so. It seems like a reasonable bet for people who have speculative money to invest, or, as I personally tend to think of it, a certain amount of 'play money' that I'm not relying on for any future purpose. As I've mentioned before, I do have a small holding and will probably add to it on dips, given the opportunity.
Just a little interesting note. David Gryska, Board Director, Chair of Audit Committee for MindMed increased his shares by 20% as of 8/23 See here: https://d1io3yog0oux5.cloudfront.net/sec/0000950170-24-100668/0000950170-24-100668.pdf What is interesting is that he sat on the board for Seagen, Inc. (NASDAQ: SGEN)... SGEN was bought out on December 14th, 2023 by Pfizer. It was a $43 billion deal --- https://mindmed.co/team/david-gryska/ Mr. Gryska possesses decades of experience as a C-suite executive and director at a number of leading public biopharmaceutical companies. He most recently served as Executive Vice President and Chief Financial Officer of Incyte Corporation, a biopharmaceutical company (NASDAQ: INCY). Additionally, Mr. Gryska served as Chief Operating Officer of Myrexis, Inc., a biopharmaceutical company as well as Senior Vice President and Chief Financial Officer of Celgene Corporation, a former publicly traded biopharmaceutical company acquired by Bristol-Myers Squibb Company. Previously, Mr. Gryska served at Scios Inc., a former publicly traded biopharmaceutical company acquired by Johnson & Johnson, as Senior Vice President and Chief Financial Officer. Mr. Gryska also served as Vice President, Finance and Chief Financial Officer at Cardiac Pathways Corporation, a former publicly traded medical device company acquired by Boston Scientific Corporation. Prior to Cardiac Pathways, Mr. Gryska served as a partner at Ernst & Young LLP in California. Mr. Gryska currently serves on the boards of directors of biopharmaceutical companies Seagen, Inc. (NASDAQ: SGEN) and Forte Biosciences, Inc. (NASDAQ: FBRX).
It's a good sign that insiders are increasing their stake - obviously. The bad news that broke recently is that Lykos, MDMN or any other company that is pursuing MDMA-based/related FDA drug approval(s) is going to have a very rough road to navigate after the latest recommendations from its advisory panel on the Lykos MDMA trials. Good news for other companies in this arena is that some - not necessarily most - of the negative findings were specific to either Lykos or these particular trials. The best news as I understand it for MNMD (based on my admittedly very limited knowledge!) is that their biggest plans are not around MDMA-class drugs. In which case the dip caused by this news might once again represent a buying opportunity.
H.C. Wainwright adjusted its outlook on MindMed (NASDAQ:MNMD) stock, increasing the price target to $55 from the previous $35 while reaffirming a Buy rating https://www.investing.com/news/comp...utlook-cites-mdd-trial-expansion-93CH-3592893
back at pre fda announcement levels. Accumulation zone for me. Perfect entry time for the next wave up. price action will be incredible as we inch through the next year from here with anticipation of phase 3 results.
Pharmacological and non-pharmacological predictors of the LSD experience in healthy participants https://www.nature.com/articles/s41398-024-03074-9
This study explored pharmacological and extra-pharmacological predictors of the LSD experience. While dose emerged as the most influential factor, traits like 'Openness to Experience', mood, and pre-drug mental states (e.g., anxiety, emotional excitability) also significantly impacted subjective effects. Sex and body weight? Not so much. Based on 9 double-blind, placebo-controlled studies with 213 participants, this research offers a deeper understanding of what shapes the LSD experience. More data from University Hospital Basel is only good as we move into Phase 3 and (fingers crossed) commercialization / buyout)... plus this data was licensed by MindMed.
Several potential signals with the recent Employee Inducement Grants for MindMed I want to go over three areas. 1; what is the outlook for Employee Inducement Grants in general with respect to biotech companies, 2; the synergies between the idea of this type of benefits package to top talent and MindMed itself, 3; the concern of dilution based on the press release. PR: https://www.businesswire.com/news/h...dMed-Announces-New-Employee-Inducement-Grants The announcement of Employee Inducement Grants in a biotech firm, especially one moving into a critical Phase 3 trial, could convey several potential signals to investors and shareholders: Talent Acquisition: Inducement grants are often used to attract top-tier talent, especially in critical phases like Phase 3 trials. This could signal the company's commitment to strengthening its workforce with experts who can ensure the trial's success and, potentially, future commercialization. Confidence in the Pipeline: Offering inducement grants may indicate management's confidence in their clinical program. They may believe the company's prospects are bright enough to make stock options and grants a valuable incentive, suggesting that they see positive outcomes on the horizon. Retention and Long-Term Incentive: Inducement grants can also be designed to retain key talent through the late-stage clinical development process, which can be intense and high-stakes. This could mean the company expects critical developments and wants to ensure the team stays on board through potential milestones. Dilution Concerns: On the other hand, depending on the size of the grants, shareholders might be concerned about stock dilution. Inducement grants increase the number of outstanding shares, which can impact stock value in the short term. In the near term, this move could reflect the company’s strategic positioning for upcoming pivotal events like trial results or partnerships. For shareholders, it is likely a positive sign that management is confident and proactive. Knowing that we're invested in MindMed, here are some specific insights in light of their recent announcement of Employee Inducement Grants and the FDA breakthrough status: Key Focus on Psychedelic Medicine: MindMed is working on MM-120 (LSD), which is being investigated for anxiety disorders, particularly Generalized Anxiety Disorder (GAD). Their status as a pioneer in psychedelic-based therapies for mental health conditions puts them in a promising but highly speculative sector. FDA Breakthrough Designation: This status indicates that MM-120 is addressing unmet needs in treatment-resistant conditions. If this candidate is in or near Phase 3, positive trial results could lead to faster market approval. The inducement grants may be part of scaling up for potential commercialization. Recruiting Experts in Regulatory and Clinical Development: Moving through Phase 3 trials and potentially to market will require MindMed to hire specialists in clinical operations, regulatory affairs, and commercial strategy. The inducement grants might be aimed at hiring or retaining personnel who can manage the complexities of regulatory submissions and partnerships with larger pharmaceutical companies. Market Sentiment: The psychedelic sector, including MindMed, tends to experience high volatility due to both regulatory uncertainty and the early-stage nature of most companies in the space. Inducement grants may reassure shareholders that the company is well-staffed for future success, though it could also trigger short-term stock price fluctuation due to potential dilution concerns. The inducement grants is a positive indication of MindMed’s growth ambitions as they push their promising therapies forward. Based on the details of MindMed's inducement grants: The issuance of inducement grants to three newly hired non-executive employees consisting of options to purchase an aggregate of 70,000 common shares of the Company (the "Options"), with an effective grant date of September 9, 2024. The Options have an exercise price equal to the closing price of MindMed’s common shares on September 6, 2024, the last trading day on which MindMed’s common shares traded prior to the date of the grant, and will vest over a four-year period with 25% vesting on October 1, 2025 and the remaining 75% vesting in substantially equal monthly increments over the three-year period thereafter, subject to each employee’s continued employment. Here’s an analysis of the potential impact on shareholders and whether there’s cause for concern regarding short-term dilution: Size of the Grant: The issuance is for 70,000 common shares, which is a relatively small number compared to the total number of outstanding shares for MindMed, This means the dilution from these options is minimal and unlikely to have a significant short-term impact on the stock price. Vesting Schedule: The options vest over a four-year period, with 25% vesting in October 2025 and the remainder vesting incrementally over three years. This slow vesting means that the full dilution won’t occur immediately. The gradual vesting ensures that the dilution is spread out over time, rather than all at once, reducing any immediate impact on shareholders. Exercise Price: The options are priced at the closing price on September 6, 2024, meaning employees will only benefit if the stock price rises above that level. If the stock price remains flat or declines, these options might not be exercised, and dilution would be avoided. Summary: Given the relatively small number of shares involved, the slow vesting schedule, and the fact that the options are only valuable if the stock price appreciates, the potential for short-term dilution is low. From a shareholder’s perspective, there’s little cause for concern about immediate dilution from these grants. That is 23,333 shares per hire (average)... considering these are top executives that want to get something accomplished. Event at a conservative target of 25.00 a share (which is very low in my opinion), each employee stands to make approx 500k on the shares alone if the price averaged 25.00 over the course of a 4 year period. Good times are ahead. This is a good thing for MindMed. They want top talent and they want to get to commercialization. I trust they will.
The announcement clearly states 'non-executive' employees. I'm guessing that means medical or technical professionals? Emphasis mine in the quotes below:
After the Lykos debacle, what’s next for psychedelic therapies? While Lykos Therapeutics’ MDMA therapy was rejected by the FDA, psychedelic therapy advocates remain optimistic about the sector. https://www.pharmaceutical-technolo...-for-psychedelic-therapies/?cf-view&cf-closed Market opinion Lykos is not alone in MDMA research, as several other companies continue to push their candidates towards approval. New York-based MindMed is developing its MDMA therapy MM-402 for treating autism spectrum disorder. Dr. Dan Karlin, CMO at MindMed, views concerns raised by the FDA committee as “Lykos-specific issues, study conduct-specific issues.” He believes MindMed’s methodology will side-step the patient and rater-blinding problems central to Lykos’ NDA rejection. Though Lykos had to demonstrate a drug effect while part of a multi part treatment, others may not use the same approach. “Rather than doing psychedelic-assisted therapy, this [MM-402] is drug treatment only,” says Karlin. Additionally, incorporating dose response analysis, expectancy assessment, blinded central raters, and excluding participants with prior psychedelic use are among measures that can shield MindMed from the failings of Lykos, says Karlin. “It will be important, whether it’s Lykos or some other company, and whether it’s MDMA or some other substance, for some other psychiatric indication, to really maintain a strong, explicit neutrality in regards to the potential for the treatment to work,” says Henner. Nonetheless, Karlin remains confident in getting psychedelics approved and, cited growing interest in psychedelics among groups supporting veterans with PTSD as a route to bipartisan political acceptance of these therapies.
Fireside chat at the 2024 Cantor Global Healthcare Conference with Robert Barrow, and CMO Dan Karlin https://wsw.com/webcast/cantor22/re...https://wsw.com/webcast/cantor22/mnmd/2081412
Bank of New York Mellon Corp Purchases 203,216 Shares of Mind Medicine (MindMed) Inc. (NASDAQ:MNMD) https://www.marketbeat.com/instant-alerts/nasdaq-mnmd-sec-filing-2024-09-19/
One thing that might be a concern is this excerpt from a risk analysis on an investing website regarding MNMD: "Shareholders have been substantially diluted in the past year."
Not overly concerned - they have cash runway to 2027... trials end in 2026... if FDA approval happens in 2026 this will explode.
Can LSD break the 20-year drought in anxiety treatment? As MindMed advances its novel LSD therapy to a Phase 3 trial, the company aims to transform treatment for generalized anxiety disorder. https://www.drugdiscoverytrends.com/lsd-phase-3-trials-anxiety-treatment-mindmed/
Functional and Sexual Disability, and Quality of Life After One Dose of MM120 (Lysergide) in Adults With Generalized Anxiety Disorder https://d1io3yog0oux5.cloudfront.ne...+Adults+with+Generalized+Anxiety+Disorder.pdf
