"Most advanced sponsors including our company
MindMed, have already implemented such steps to mitigate
these potential biases and enhance the internal and external
validity of clinical trials"
MedNous September 2023
This article was written by Dr Daniel Karlin, Chief
Medical Officer, and Robert Barrow, Chief Executive
Officer, of Mind Medicine Inc.
Commentary: FDA guides industry on psychedelic drugs
In June 2023, the US Food and Drug Administration’s Center
for Drug Evaluation and Research (CDER) published its
first draft guidance on drug development for the class of
drugs known as psychedelics. The agency intends for this
guidance to "help researchers design studies that will yield
interpretable results that will be capable of supporting future
Naturally occurring psychedelics have a long history of use
in indigenous communities. More broad interest in the class
began with the discovery of synthetic psychedelic molecules
in the 1930s, which were widely studied for their therapeutic
potential during the mid-20th century, yielding promising
preliminary results. However, due to a multitude of non-
scientific factors, research into their therapeutic potential
became increasingly difficult after much of the class was
classified as illegal controlled substances, with no currently
accepted medical use and a high potential for abuse. This
nearly worldwide classification made it extremely difficult for
researchers to obtain funding and conduct further studies of
psychedelics. Most research was abruptly halted in the 1970s.
Despite these obstacles, the past decade has seen a
renaissance in research of psychedelics. Beginning in the
mid-2010s, a series of groundbreaking studies that confirmed
the promising findings from legacy studies led to renewed
research interest in the drug class and the potential to
treat a wide range of brain health disorders – including,
in particular, strong and durable effects in anxiety and
depression among other disorders.
Public acceptance of psychedelic therapies by healthcare
providers and potential patients is crucial for widespread
adoption and access to these treatments. By aligning with the
FDA's guidelines, researchers and companies gain credibility,
increasing the chances of acceptance by the medical
community and the general public. FDA has long taken a
forward-thinking, leadership position in facilitating rigorous
research methodologies and regulatory pathways for this
promising drug class, and this guidance further clarifies the
programme and study-level methodological considerations
that need to be addressed in order to ultimately obtain
marketing authorisation for drugs of the class. These
considerations are especially relevant with the psychedelic
drug class, which must contend with unique challenges and
opportunities given the paradigm-shifting delivery models
and implications for clinical research.
The FDA plays a pivotal role in regulating drug
development and facilitates the efficient advancement
of novel research by proactively guiding sponsors and
researchers on the key considerations that could drive
regulatory action in the future. With this drug class-specific
guidance, the FDA has taken a significant step forward in
clarifying the regulatory and R&D expectations in our field.
The new guidelines provide a framework for conducting
adequate, well-controlled, scientifically rigorous trials that
can assess the safety and effectiveness of the drug class.
While addressing unique aspects of developing psychedelics,
the guidance also reinforces fundamental principles that are
key to developing any new psychiatric therapy.
With regard to the guidelines themselves, biopharma
veterans will find the FDA’s thinking on these issues to
be in line with prevailing best practices for just about any
other typical pharmaceutical product, especially in the
world of central nervous system (CNS) and neuropsychiatric
treatments. As stated in the document, “the substantial
evidence standard for establishing effectiveness of
psychedelic drugs is the same as it is for all other drugs.”
While some of the topics covered in the guidance may appear
to be unique to the psychedelic drug class, we note that the
vast majority are common to research of all CNS-active
pharmacotherapies but may be simply more pronounced for
psychedelics. For instance, the guidance highlights the issue
of functional unblinding, a topic that is particularly relevant
given the likely obvious, profound nature of the acute
perceptual disturbances resulting from the administration of
psychedelics. While this topic may be particularly pronounced
for psychedelics, it is not unique. Many drugs – and virtually
all of the approved CNS agents that are controlled substances
– suffer from potential functional unblinding due either
to the directly observable pharmacodynamic effects (e.g.
dissociative effects of NMDA antagonists) or indirectly due to
high incidence adverse events.
The guidance offers well-reasoned steps that sponsors
can take to mitigate these potential biases, such as using
video or central raters to make assessments as objective as
possible. Most advanced sponsors including our company
MindMed, have already implemented such steps to mitigate
these potential biases and enhance the internal and external
validity of clinical trials.
The draft guidance also considers the respective roles of
psychotherapy and non-therapy session monitors in clinical
trials. These topics remain some of the most widely debated
among practitioners and supporters, warranting careful
deliberation in pursuing effective guidance for drug sponsors.
While the guidance provides specific expectations of the
qualifications of session monitors, it also rightly highlights
the complications introduced with concurrent psychotherapy.
Additionally, we note that as with most clinical research
studies, the strict research protocols mandated by the FDA
and sponsors are likely to be overly restrictive and are rightly
intended to maximise the quality and integrity of data that
is intended to support claims of safety and effectiveness. We
anticipate that future real-world research – assuming these
products are approved and marketed – will be critical to set
the standards for the practice of medicine and to elucidate
treatment protocols that maximise patient benefit.
While the guidance leaves room for further clarification and
an evolution of thought as additional evidence is generated,
the regulatory framework enumerated in this draft guidance
provides the greatest clarity of regulatory expectations and
R&D considerations to date.
Slide Deck Comparisons
Sept 2023 - https://mindmed.co/wp-content/uploads/2023/09/MindMed-Investor-Presentation-September-2023.pdf
March 2023 - https://mindmed.co/wp-content/uploads/2023/03/MindMed-Investor-Presentation-March-2023.pdf
Page 1 - No Change - except dates
Page 2 - No Change
Page 3 - March 2023 had a business highlights page, in September 2023 we have now flag-shipped the MM-120 and MM-402 programs
Page 4 - We have moved the "There is an Urgent Need for Better Treatments" slide from what was on Page 6 prior up to page 4. ANXIETY figure was removed in favor of the term GAD and the percentage was adjusted from 21% to 10%. Previous figures were pulled from NIMH 2020; Mental Illness where as the new figures are pulled from Mental and Substance Use Disorders Prevalence Study (MDPSU): Findings Report 2023 - Keeping in mind that ANXIETY is different from the term GAD and while the percentage is lower it is now targeted to GAD.
Page 5 - Pipeline remains unchanged.
Page 6 - "Advancing the Field with Strong IP & Strategic Competitive Moats" slide has remain unchanged
Page 7 - "MM-120 - LSD D-tartrate" Title Slide has now changed the "Key Milestones Anticipated" from "GAD Readout - Late 2023 | Phase 2b" and "ADHD Readout - Late 2023 | Phase 2a" to now read "Phase 2b in GAD Topline Data | Q4 2023" and "Phase 2a in ADHD Topline Data | Q4 2023 / Q1 2024" respectively.
Page 8 - "Lead Candidate with Evidence Across Multiple Therapeutic Areas" remains unchanged.
Page 9 - "Emerging Treatment Paradigm for Brain Health Disorders" remains unchanged.
Page 10 - New Slide - "Mechanism of Action Driving Potential Durable Clinical Response" in regards to LSD
Page 11 - New Slide - "An Urgent Need for Better Anxiety Treatments" presents general data points on current SSRI issues and why new treatments are needed.
Page 12 - "Legacy of LSD Clinical Research in Psychiatric Disorders" - has now updated and split the entry on the the table from "UHB’s LSD-Assist" entry to now include both "HOLZE 2022" which correlated with the UHB entry and also includes "HOLZE 2023" outlining an additional 61 patient study.
Page 13 - "Modern Evidence in Anxiety Disorders" title has been updated with the term Modern which was not present in the last version of this slide. Remaining data is unchanged.
Page 14 - "Phase 2b Generalized Anxiety Disorder (GAD)" title has been reduced from "MM-120 | Phase 2b Generalized Anxiety Disorder (GAD)" Removing MM-120 from the headline, still present in slide.
Page 15 - "Potential MM-120 Clinical Care Model" remains unchanged
Page 16 - "Digital Unlocks Potential Opportunities Throughout the Product Lifecycle" has moved up from page 31 on March slide deck. No changes. Could suggest push for digital in these trials.
Page 17 - "Potential Pathway to Commercial Success for MM-120" remains unchanged
Page 18 - "Phase 2a Attention-Deficit Hyperactivity Disorder (ADHD)" title has been reduced from "MM-120 | Phase 2a Attention-Deficit Hyperactivity Disorder (ADHD)" Removing MM-120 from the headline, still present in slide. As the main slide for this area we do have new topics and points related to this study.
Page 19 - "Phase 2a Attention-Deficit Hyperactivity Disorder (ADHD)" timeline slide for study remains unchanged.
Page 20 - "MM-402 R(-)-MDMA" Title Slide has now changed the "Key Milestones Anticipated" from "Phase 1 Study Initiation 2023 | Phase 1" to now read "Phase 1 Study Initiation | Q4 202" and "Phase 1 IIT (UHB-Sponsored) Topline Data | H1 2024".
Page 21 - New Slide - "Differentiated Mechanism of Action Targets Key Pathways" in regards to R-MDMA
Page 22 - "No Approved Drugs for Core Symptoms of Autism Spectrum Disorder (ASD)" remains unchaged
Page 23 - "Preclinical Data Indicate Potential Enhanced Benefit/Risk Profile" remains unchanged
Page 24 - "Clinical Data Support Opportunity for MDMA in ASD" remains unchanged.
Page 25 - Collaborations & Early R&D" Title Slide - remains unchanged.
Page 26 - "External Collaborations Aim to Accelerate Discovery & Development" remains unchanged
Page 27 - "Exclusive Collaboration with Leading Researchers" remains unchanged.
Page 28 - "Our Leadership Team" - Moved to this page from being on page 4 previsouly and has now added Mark Sullivan, JD CLO. All team members have new photos.
Page 29 - "Our R&D Leadership Team" no changes other than new photos for all team members.
Page 30 - New Slide - "Our Team Has Significant Drug Development Experience" sub tag reads "Our Management and R&D team’s relevant experience overseeing the approval of drug candidates positions MindMed for success" with both CNS and Other drug products listed. Quite attractive to say the least :)
Page 31 - "Business Highlights" changes to the last 3 points. Expected cash runway into 2026 ($116.9 million and committed credit facility are expected to fund operations into 2026, if certain milestones are achieved that unlock additional capital.) LSD and MDMA study timeline terminology updated.
Page 32 - Last Slide - Logo - Remains unchanged
Slides Removed: Slides related to Digital "Digital to Complement Drug Delivery Through the Patient Journey", "Digital Enables Alignment of Incentives for Broad Market Access", "Digital Pipeline Progression Aligns with Drug Development" and Slides related to MM-110 have been removed.
I don't believe this is for any other reason that to concentrate fully on the studies, digital was mentioned in Page 16. That is all that is needed.
MM-110 is mentioned on pipeline page with same sub note as previous.
MDMA as psychiatric treatment moves closer to US approval
This is going to get crazy here when this passes considering:
MindMed Completes Enrollment of Phase 2b Trial of MM-120 in Generalized Anxiety Disorder (GAD)
– 198 participants dosed across 20 clinical sites –
– On track for topline results in Q4 2023 –
September 12, 2023 07:30 AM Eastern Daylight Time
NEW YORK--(BUSINESS WIRE)--Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (NEO: MMED) (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, announced today that it has completed enrollment and dosing in Study MMED008, the Company’s Phase 2b study evaluating MM-120 (lysergide D-tartrate) for the treatment of GAD.
“Completion of enrollment of this study is a significant milestone for MindMed and moves us one step closer to our goal of transforming the treatment of GAD for the millions suffering from the disorder,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “Thanks in large part to the enthusiasm we have seen regarding MM-120 among investigators and patients, as well as the strong execution of our team, we were able to enroll almost 200 participants in this trial in just over a year. We anticipate sharing topline results during the fourth quarter of this year.”
Study MMED008 is a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. The trial has enrolled 198 participants who were randomized to receive a single administration of 25 µg, 50 µg, 100 µg or 200 µg of MM-120, or placebo. The primary objective of the study is to determine the dose-response relationship of four doses of MM-120 versus placebo as measured by the change in Hamilton Anxiety Rating Scale (HAM-A) from baseline to week 4. Key secondary objectives, measured up to 12 weeks after the single administration, include assessments of anxiety symptoms, safety and tolerability, as well as other measures of efficacy and quality of life. More information about the trial is available on our website (mindmed.co), the trial’s website (anxietyresearchstudy.com) or on clinicaltrials.gov (identifier NCT05407064).
MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders.
MindMed trades on NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED.
Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”, “believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release includes, but is not limited to, statements regarding anticipated timing and results from the Phase 2b clinical trial of MM-120] and the potential benefits of the Company’s product candidates. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; lack of product revenue; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022, the Company’s Quarterly Report on Form 10-Q for the fiscal quarter ended June 30, 2023 under headings such as “Special Note Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and other filings and furnishings made by the Company with the securities regulatory authorities in all provinces and territories of Canada which are available under the Company’s profile on SEDAR at www.sedar.com and with the U.S. Securities and Exchange Commission on EDGAR at www.sec.gov. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events, changes in expectations or otherwise.
For Media & Investor Inquiries, please contact:
Maxim Jacobs, CFA
Vice President, Investor Relations and Corporate Communications
Mind Medicine (MindMed) Inc.
Swing trading scum. Muted.
Mind Medicine (MindMed) Inc NASDAQ: MNMD
Health Care : Pharmaceuticals | Small Cap Value | Based in CanadaCompany profile
Mind Medicine (MindMed) Inc. is a clinical-stage biopharmaceutical company. The Company is engaged in developing products to treat brain health disorders. It is developing a pipeline of product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways. This specifically includes pharmaceutically optimized product candidates derived from the psychedelic and empathogen drug classes, including MM-120 and MM-402, the Company's product candidates. MM-120 is a pharmaceutically optimized form of lysergide D-tartrate that the Company is developing for the treatment of generalized anxiety disorder (GAD). MM-120 is also being studied in a subperceptual repeat administration dosing regimen for the treatment of attention deficit hyperactivity disorder (ADHD). MM-402, also referred to as R(-)-MDMA, is the Company's form of the R-enantiomer of 3,4-methylenedioxymethampheta (MDMA), which the Company is developing for the treatment of autism spectrum disorder (ASD).
If you have tried LSD (a reasonable amount that is not and ego death trip - lol) you know these compounds work... you just do. It will make cannabis as a medicine seem like child's play. Big things are coming. Hold your tickets. I have a substantial feeling they will be bought out. When that happens you will be glad you held.
My Take on What’s Happening with MNMD
Share price is steadily increasing because someone, possibly FCM or insiders, is trying to scoop up a controlling percentage of shares. Essentially, the buyer purchases a decent amount of shares on one day, then turns around to sell a small percentage of the shares once the price has run up. This basically funds the accumulation of shares.
For example, buy 100,000 shares at 3.75-4 then sell 30,000 at 4.35-4.50, maybe sell some covered calls as well and sell to open some puts for extra liquidity. Rinse and repeat as share price rises, keeping the foot on the gas pedal.
This is a classic technique for establishing a position.
Also, MNMD has massive potential. MM-120 could be a truly revolutionary medication. The medical conditions (anxiety, mood disorders, ADHD) targeted by MM-120 already have numerous multi-billion dollar medications. MM-120 could be a $10b plus medication which would value the company around 2x+ revenue or $20-30b giving MNMD a share price north of 100 (as high as 300+).
Obviously pie in the sky numbers but worthwhile throwing some money at MNMD. I’m sure if someone told you GME would go from 3 to 300 in a little over a month you would have just laughed at them.
Anyhoo, happy weekend!
Alas MNMD Was Overbought
Sorry to see the pullback fall and close below $4.10; which was first floor of support.
True. State and Federal Goverments have Mismanaged Legalization
The mismanagement of legal cannabis is just a long line of issues with how states and the Fed have handled the situation and ultimately has been a massive drag on how publicly traded companies can participate in the legal industry. The Schedule 2 classification prevents federally regulated banks from participating which forces the legal cannabis industry to primarily use cash for all their business needs. Absurd taxes have murdered the legal market. Cannabis is taxed anywhere from 10-100x higher than other “sin” taxes for liquor, cigarettes or gambling. Even more absurd is that while the feds consider cannabis illegal on a national level they are all to willing to take some of those oh so sweet tax dollars.
The beauty here is that the markets will dictate the outcome, not stuffy old institutions, and as long as one can hold out long enough there will be hope for reform. Prior to legalization cannabis was so ubiquitous in California that the state was basically forced to legalize, first medically via Prop 215 and later via SB 420.
Same thing is happening with psychedelics. Many dispensaries in the LA area already openly sell mushrooms.
Once all the federal and state bullshit is washed away, the floodgates will open. Banks will open their doors to loans, financing and capital investment. There will be a medical, recreational and Industrial revolution all wrapped into one juggernaut once cannabis and psychedelic prohibition is lifted
which is the problem w/ binary type stocks that have no fda approved drugs AND will have to rely on legislative changes to allow for access.
Since MJ legislation appears to be falling to the wayside (at least until Nov 2024 during an election year), I'm assuming legislation for psychedelics have been derailed too...
The Numbers are Based on Industry Comps
Obviously it’s quite impossible to come up with numbers for psychedelic drugs that aren’t at market yet so I’m basing numbers on comparable drugs already on the market. Zoloft, Paxil, Xanax, Adderall…..medications such as those bring in about $3-7b annual revenues.
If MNMD is able to market an anti-anxiety/PTSD/ADHD medication similar to those listed above then I think $3-5b revenue would be possible. Of course with that sort of revenue MNMD would likely be valued much higher, say 2x revenue for $6-10b
Big pharma is scared about psychedelics. For decades they have used law enforcement, the legal system and propaganda to suppress psychedelics. I mean the US and other governments did loads of testing with LSD, psilocybin, mescaline, ecstasy….and what was the result….they freaking banned it. Sure, smoke ciggys, drink booze, take our pills/medicine that you cannot make on your own….but LSD baaaaaaad?!?!?!?
The walls are coming tumbling down. By all means it seems the US is more likely to ease restrictions on psychedelics long before the end cannabis prohibition. And let’s hope MNMD is in good order when the day comes…
Thanks, and what are your calculations/valuations for other binary psychedelic companies like MNMD who also do not have any fda approved drugs?
In the Meantime, Here are Some Basic Numbers
MNMD has a float of 32mm shares. At 75pps that gives MNMD a valuation of $2.5b which in my guesstimate is actually quite low. Should the LSD based anxiety medication be a winner I think MNMD could actually be worth $5-10b based on comparable drug revenues.
Of course this is exceptionally optimistic but not outside the real of possibility. The pie in the sky share price could be $100+
Thanks that'd be awesome
I will draft something up here soon... need to pull my details together.
Thanks. Would you mind sharing the projected valuations, the numbers that support your feelings?
These are my valuations based on the sector, share count and what I perceive their value to be on the market. It is not a technical indicator, but rather a gut feeling.
just out of curiosity, based on what?
can you do a screenshot of your projections in graph form?
Easy long term target of 75ish territory.
Short term 10.00 with year end readout on mm-120 trial.
Could become new floor until readout at end of the year.
Low Key Accumulation Happening with MNMD
Since the FCM spat was resolved there seems to be some low key accumulation of MNMD shares. Considering the small outstanding share count (less than 35mm) anyone trying to establish a position would likely do so in subdued increments otherwise they run the risk of a frenzy that might drive up the price.
Maybe FCM is making a takeover play? Maybe info for Phase 2 trials is coming in the back half of 2023 and insiders are optimistic? Who knows?
Get in, sell covered calls. If this one rips, being a biopharma company, share price could easily shoot north of 20pps. I’ve seen it happen before will other pharma stocks, going from 5 to 25 over nice and then 75 in just a week
Looking to Fill the Gap at 6
Seems doable but not sure after that.
I have a feeling we will get another wave. First one was too easy to miss. This one I have been loading all through this current zone ready for next breakout!