MomsSpaghetti
4 days ago
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.
Giovanni
1 week ago
That is a long winded explanation of an event that may never come to pass.
It cost MindMed exactly nothing to incentives their scientific employes to keep their nose to the grindstone.
Standard Operating Procedure.
It helps to run a drug business if one has previous experience.
The FDA has approved over 33,000 drugs to later take 13000 of them off the market.
How many FDA approved drugs have been taken off the market?
Guess what happened to thoses companies? Longs were eviserated.
How many FDA approved drugs have been taken off the market?
Summary of Findings
There has been a total of 15,749 drug recalls since 2012, with 15,351 recalls specifically happening in the U.S. Since 2012, there have been 2,193 ongoing recalls, 807 completed recalls, and 13,254 terminated recalls.Apr 1, 2024
How many FDA approved drugs have been taken off the market?
Summary of Findings
There has been a total of 15,749 drug recalls since 2012, with 15,351 recalls specifically happening in the U.S. Since 2012, there have been 2,193 ongoing recalls, 807 completed recalls, and 13,254 terminated recalls.Apr 1, 2024
How many FDA approved drugs have been taken off the market?
Summary of Findings
There has been a total of 15,749 drug recalls since 2012, with 15,351 recalls specifically happening in the U.S. Since 2012, there have been 2,193 ongoing recalls, 807 completed recalls, and 13,254 terminated recalls.Apr 1, 2024 many FDA approved drugs have been taken off the market?
Summary of Findings
There has been a total of 15,749 drug recalls since 2012, with 15,351 recalls specifically happening in the U.S. Since 2012, there have been 2,193 ongoing recalls, 807 completed recalls, and 13,254 terminated recalls.Apr 1, 2024
How many FDA approved drugs have been taken off the market?
Summary of Findings
There has been a total of 15,749 drug recalls since 2012, with 15,351 recalls specifically happening in the U.S. Since 2012, there have been 2,193 ongoing recalls, 807 completed recalls, and 13,254 terminated recalls.Apr 1, 2024
Summary of Findings
There has been a total of 15,749 drug recalls since 2012, with 15,351 recalls specifically happening in the U.S. Since 2012, there have been 2,193 ongoing recalls, 807 completed recalls, and 13,254 terminated recalls.Apr 1, 2024
MomsSpaghetti
1 week ago
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/home/20240909361119/en/MindMed-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.
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