Up 12.5%! During his first term, Trump emphasized deregulation and aimed to streamline the drug approval process through initiatives like the Right to Try Act (which expanded access to experimental drugs) and Fast Track initiatives for certain therapies. He also appointed FDA commissioners like Scott Gottlieb, who, although focused on public health, pushed for more efficient approval processes while still maintaining safety standards. This could be seen as positive for biotech companies, as it might lead to faster approvals for new drugs and treatments. Having said that. I'm bullish on a buyout more than ever now because of this.
I am following MNMD and have taken a very small position, but I am not in favor of making the approval process more lenient or with less rigorous testing and trials. There are too many medications out there already that are killing too many people, just because they work for more people than they kill, and make the pharmaceutical companies a crap ton of money. "Right to Try" experimental drugs make be okay as long as the guinea pigs, er, test subjects, are fully and honestly informed of the risks. "Fast Track" is fine, when no serious side effects are discovered in early trials and the potential patients who could benefit are underserved - which to me means, don't currently have meaningful treatments widely available.
MindMed Reports Third Quarter 2024 Financial Results and Business Updates --On track to initiate the Phase 3 Voyage study of MM120 Orally Disintegrating Tablet (ODT) in Generalized Anxiety Disorder (GAD) in the fourth quarter of 2024; 12-week topline data anticipated in the first half of 2026-- https://www.businesswire.com/news/h...r-2024-Financial-Results-and-Business-Updates --On track to initiate the Phase 3 Panorama study of MM120 ODT in GAD and the Phase 3 Emerge study of MM120 ODT in Major Depressive Disorder (MDD) in the first half of 2025-- --Cash and cash equivalents of $295.3 million as of September 30, 2024, expected to fund operations into 2027 and extend at least 12 months beyond the first Phase 3 topline data readout for MM120 ODT in GAD-- --Company to host a conference call today at 4:30 p.m. EST-- November 07, 2024 04:01 PM Eastern Standard Time NEW YORK--(BUSINESS WIRE)--Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (the "Company" or "MindMed"), a clinical-stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced its financial results for the quarter ended September 30, 2024, and provided a business update. “Management's Discussion and Analysis of Financial Condition and Results of Operations” Post this “This is a pivotal moment for MindMed as we prepare to initiate Voyage, our first Phase 3 study of MM120 ODT in GAD,” said Rob Barrow, Chief Executive Officer of MindMed. “Beyond Voyage, we are on track to initiate two additional Phase 3 studies: the Panorama study, our second trial in GAD, and the Emerge study, our first trial of MM120 ODT in MDD. Our Phase 3 development strategy leverages high-performing clinical trial sites from our Phase 2 study, as well as thoughtfully aligned protocols, which we expect to enable efficient enrollment across GAD and MDD. Our strong execution throughout the year has positioned us as a well-financed, late-stage clinical leader, set to launch three Phase 3 studies targeting two indications affecting approximately 51 million adults in the U.S. I could not be more pleased with our progress as we continue to build a high-performing organization dedicated to transforming the standard of care for people with brain health disorders.” Program Updates and Anticipated Milestones MM120 (lysergide D-tartrate) for GAD The Company is on track to initiate the Phase 3 Voyage study of MM120 ODT, a pharmaceutically optimized form of lysergide D-tartrate (LSD) for the treatment of adults with GAD in the fourth quarter of 2024. The Company expects the topline readout from the 12-week double-blind period (Part A) of Voyage in the first half of 2026. The Phase 3 clinical program for MM120 ODT in GAD consists of two clinical studies: the Voyage study (MM120-300) and the Panorama study (MM120-301). Both studies are comprised of two parts: Part A, which is a 12-week, randomized, double-blind, placebo-controlled, parallel group study assessing the efficacy and safety of MM120 ODT versus placebo; and Part B, which is a 40-week extension period during which participants will be eligible for open-label treatment with MM120 ODT, subject to certain conditions for treatment eligibility. Voyage is anticipated to enroll approximately 200 participants in the U.S. who will be randomized 1:1 to receive MM120 ODT 100 µg or placebo, and Panorama is anticipated to enroll approximately 240 participants (randomized 5:2:5 to receive MM120 ODT 100 µg, MM120 ODT 50 µg or placebo). The primary endpoint for each study is the change from baseline in Hamilton Anxiety Rating Scale (HAM-A) score at Week 12 between MM120 ODT 100 µg and placebo. Both studies are expected to employ an adaptive design with interim blinded sample size re-estimation based on nuisance parameters (e.g. participant retention rate, variability of primary outcome measure) which allows for an increase of sample size up to 50% to maintain statistical power. Panorama, the second Phase 3 study, will be conducted in the U.S. and Europe and is on track to initiate in the first half of 2025 with an anticipated topline readout from the 12-week double-blind period (Part A) in the second half of 2026. MM120 (lysergide D-tartrate) for MDD The Company is also developing MM120 ODT for the treatment of adults with MDD, beginning with the Emerge study (MM120-310) which, like the Phase 3 studies in GAD, is comprised of two parts: Part A, which is a 12-week, randomized, double-blind, placebo-controlled, parallel-group study assessing the efficacy and safety of MM120 ODT versus placebo; and Part B, which is a 40-week extension period during which participants will be eligible for open-label treatment with MM120 ODT, subject to certain conditions for treatment eligibility. Emerge is anticipated to enroll at least 140 participants (randomized 1:1 to receive MM120 ODT 100 µg or placebo). The primary endpoint is the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) score at Week 6 between MM120 ODT 100 µg and placebo. The Company expects to initiate Emerge in the first half of 2025 with an anticipated topline readout from the 12-week double-blinded period (Part A) in the second half of 2026. The Company expects to conduct a second Phase 3 registrational study in MDD, with the study design and timing to be informed by the progress of Emerge and additional regulatory discussion. MM402 (R(-)-MDMA) for Autism Spectrum Disorder (ASD) In October, the Company completed a Phase 1 study of MM402, a single-ascending dose study in adult healthy volunteers. The study was intended to characterize the tolerability, pharmacokinetics and pharmacodynamics of MM402. The Company expects to initiate further studies of MM402 for the potential treatment of ASD, with the exact timing and scope of such studies to be determined. Third Quarter 2024 Financial Results Cash Balance. As of September 30, 2024, MindMed had cash and cash equivalents totaling $295.3 million compared to $99.7 million as of December 31, 2023. The Company believes that its cash and cash equivalents as of September 30, 2024, will be sufficient to fund the Company’s operations into 2027. Based on the Company’s current operating plan and anticipated R&D milestones, the Company expects its cash runway to extend at least 12 months beyond its first Phase 3 topline data readout for MM120 ODT in GAD. Net Cash Used in Operating Activities. For the nine months ended September 30, 2024, net cash used in operating activities was $53.8 million, compared to $43.8 million in the nine months ended September 30, 2023. Research and Development (R&D). R&D expenses were $17.2 million for the quarter ended September 30, 2024, compared to $13.2 million for the quarter ended September 30, 2023, an increase of $4.0 million. The increase was primarily due to $2.1 million in expenses related to our MM120 program supporting the advancement into pivotal studies for the treatment of adults with GAD, $0.9 million in expenses related to our MM402 program, $0.6 million in internal personnel costs as a result of increasing research and development capacities, and an increase of $0.4 million in expenses related to preclinical activities. General and Administrative (G&A). G&A expenses were $7.6 million for the quarter ended September 30, 2024, compared to $8.4 million for the quarter ended September 30, 2023, a decrease of $0.8 million. The decrease was primarily attributable to lower spending in legal and commercial activities, partially offset by an increase in stock-based compensation expense. Net Loss. Net loss for the quarter ended September 30, 2024, was $13.7 million, compared to $17.9 million for the same period in 2023, a decrease of $4.2 million. The decrease was primarily due to changes in the fair value of warrants issued in our September 2022 underwritten offering of $5.3 million partially offset by an increase in research and development expense. Conference Call and Webcast Reminder MindMed management will host a conference call at 4:30 PM EST today to provide a corporate update and review the Company’s third quarter 2024 financial results. Listeners can register for the webcast via this link. Analysts wishing to participate in the question-and-answer session should use this link. A replay of the webcast will be available via the Investor Relations section of the MindMed website, ir.mindmed.co and archived for at least 30 days after the webcast. Those who plan on participating are advised to join 15 minutes prior to the start time. About MM120 MM120 (lysergide D-tartrate or LSD) is a synthetic ergotamine belonging to the group of classic, or serotonergic, psychedelics, which acts as a partial agonist at human serotonin-2A (5-hydroxytryptamine-2A [5-HT2A]) receptors. MindMed is developing MM120, the tartrate salt form of lysergide, for GAD and MDD and is exploring its potential applications in other serious brain health disorders. Based on the significant unmet medical need in the treatment of GAD – especially in patients who do not respond to or tolerate currently available medications – along with the initial clinical data from Phase 2b and other research conducted by MindMed, the U.S. Food & Drug Administration (FDA) has designated MM120 for GAD as a breakthrough therapy. The MM120 ODT Phase 3 clinical development program includes the Voyage and Panaroma studies in GAD and the Emerge study in MDD. Additional clinical indications under consideration. About MM402 MM402 is the Company’s proprietary form of R(-)-MDMA (rectus-3,4-methylenedioxymethamphetamine), being developed for the treatment of core symptoms of ASD. MDMA is a synthetic molecule that is often referred to as an empathogen because it is reported to increase feelings of connectedness and compassion. Preclinical studies of R(-)-MDMA demonstrate its acute pro-social and empathogenic effects, while its diminished dopaminergic activity suggest that it has the potential to exhibit less stimulant activity, neurotoxicity, hyperthermia and abuse liability compared to racemic MDMA or the S(+)-enantiomer. About MindMed 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. MindMed trades on NASDAQ under the symbol MNMD.
RFK Jr. Pledges To Legalize Marijuana And Psychedelics, Using Revenue To Fund Farms Where People Recovering From Drug Addiction Can Grow Organic Food https://www.marijuanamoment.net/rfk...ng-from-drug-addiction-can-grow-organic-food/ “I would legalize psychedelic drugs—some form of legalization,” he said, adding that he doesn’t necessarily envision a commercial market where anyone could visit a shop to buy the substances, but that there should be regulated access”
Blackrock now owns 7% of MNMD https://ir.stockpr.com/mindmed/sec-.../0002012383-24-003562/ca60255c8850_110824.txt
The problem with regulated access is that prices will be $1000 per pill and there will be a mountain of paperwork and background checks involved. Meanwhile, people will be able to buy ostensibly the same pill from a trench coated man wearing socks and saddles, standing just outside the door of the dispensary, for $1.50 per pill. Government will never be able to compete with the efficiency or honesty of drug dealers.
As someone who unfortunately had some first hand experience with drug dealers in the distant past, your statement is a strong testimonial to the dishonesty and inefficiency inherent in government - as drug dealers are inefficient as hell and as dishonest as the devil himself, in my experience. They can't even tell the truth to themselves, they wouldn't recognize the truth if it slapped them in the face - as it sometimes does.
That quote was written a bit tongue-in-cheek as hyperbole to convey my distrust and dislike of government. It was intended to amuse but the sentiment is not without a kernel of truth.
Plus the Earnings Webcast: https://edge.media-server.com/mmc/p/846ghfnx/ You can just fill in the form to listen to the replay for 30 more days. This is an overview of this PR: https://ir.mindmed.co/news-events/p...r-2024-financial-results-and-business-updates In all seriousness. This is a really good company I know the RFK stuff was tongue in cheek. However, this company is going to succeed.
$MNMD Mind Medicine (MindMed)'s (MNMD) Buy Rating Reiterated at HC Wainwright - 55.00 https://www.marketbeat.com/instant-...ating-reiterated-at-hc-wainwright-2024-11-11/
As it related to importation of Schedule II substances. MindMed got this. I had to do some digging, but to get for example their ODT LSD tablets into the US once approved they will have to follow: DEA Form 357 - Application for Permit to Import Controlled Substances for Domestic and/or Scientific PurposesDEA Form 357 - Application for Permit to Import Controlled Substances for Domestic and/or Scientific Purposes and The importation must adhere to the regulations outlined in Title 21 of the Code of Federal Regulations (CFR), Part 1312. These regulations detail the procedures and requirements for importing controlled substances. https://www.ecfr.gov/current/title-21/chapter-II/part-1312?toc=1 I am not concerned about this at all and you can bet their team is already on this ahead of approval or anything else. That is just smart business practice. Take this for what is is worth, but if LSD is rescheduled to CII and MindMed gets FDA approval they will get this. For example for those still having doubts: Cocaine is a Schedule II drug under the Controlled Substances Act, meaning it has a high potential for abuse and has an accepted medical use for treatment in the United States. Cocaine is derived from the coca plant, which is primarily cultivated in South American countries such as Colombia, Peru, and Bolivia. For medical use in the U.S., pharmaceutical-grade cocaine is imported from these regions under strict regulatory oversight. Once imported, it is processed and packaged by pharmaceutical companies for medical distribution. Several pharmaceutical companies are authorized to manufacture and distribute cocaine hydrochloride for medical purposes in the United States. These companies produce and package cocaine hydrochloride under strict regulatory oversight for use as a local anesthetic in specific medical procedures. Notable companies include: Mallinckrodt Pharmaceuticals: Offers Cocaine Hydrochloride USP CII in various package sizes, such as 5 grams and 25 grams. Lannett Company, Inc.: Manufactures Numbrino, a cocaine hydrochloride nasal solution approved by the FDA for use as a local anesthetic during nasal surgeries Genus Lifesciences Inc.: Produces Goprelto, a cocaine hydrochloride nasal solution indicated for the induction of local anesthesia of the mucous membranes during diagnostic procedures and surgeries on or through the nasal cavities in adults. Having said all that... MindMed gets either bought out just prior to approval or if approval happens. Even without a buyout and no revenue the company will be valued at billions. We are just getting started.
