MomsSpaghetti
23時間前
New Association Launches to Expand Patient Access to Psychedelic Medicines
https://www.prnewswire.com/news-releases/new-association-launches-to-expand-patient-access-to-psychedelic-medicines-302311365.html
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Association for Prescription Psychedelics
Nov 20, 2024, 06:56 ET
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Organization Will Educate Policymakers and Advocate for the Development of Safe and Effective Prescription Psychedelics
WASHINGTON, Nov. 20, 2024 /PRNewswire/ -- The Association for Prescription Psychedelics (APP) announced its launch today to integrate proven, efficacious, and evidence-based prescription psychedelic medicines into the health care system for eligible patients across the country.
APP will serve as a trusted and recognized voice on prescription psychedelics and highlight how government-sponsored research, public-private partnerships, patient centric treatment, and health care infrastructure investments can support this innovative area of medicine.
"There's a tremendous opportunity to address the unmet needs of patients across the country who are experiencing a wide range of health challenges by expanding access to psychedelic medicines," said Jon Kostas, Executive Director of APP and Chief Executive Officer of Apollo Pact. "The Association for Prescription Psychedelics will serve as the leading voice for clinical, evidence-based psychedelic medicines and treatments administered by licensed, experienced, and highly trained professionals in the medical community."
APP will be guided by prominent researchers and academics from the University of Alabama at Birmingham, Heffter Research Institute, University of Wisconsin, Shepard Pratt, Cleveland Clinic, Johns Hopkins University, and University of California San Francisco. The organization's founding members include B.More Inc., Compass Pathways, Lykos Therapeutics, and MindMed. APP's patient advocacy organization partners include Apollo Pact.
"Fostering strong collaboration between industry, academia, health care professionals, and policymakers can help advance scientific research into psychedelics and hopefully expand patient access to lasting and effective treatments," said Peter Hendricks, PhD, Professor and Heersink Endowed Chair of Psychiatry at the University of Alabama at Birmingham, who serves on as one of APP's scientific advisors. "Psychedelic research looks very promising for many treatment-resistant patients, and there is a good chance prescription psychedelic medicines will be a part of our healthcare system in the near future."
"As someone who credits psychedelic research with saving my life, I understand firsthand the life-changing effects of these treatments," added Kostas.
Visit psychedelicsRX.org to learn more.
About the Association for Prescription Psychedelics
The Association for Prescription Psychedelics (APP) works to educate and advocate for the development and accessibility of safe and effective prescription psychedelic medicines for patients. We serve as the trusted and recognized industry voice – at the national and state levels – on prescription psychedelic medicine and its integration into the healthcare system. Our education efforts help policymakers, regulators, and other key stakeholders learn about psychedelics and entactogens/empathogens and the associated medical conditions each compound may be able to treat. Our advocacy efforts help advance responsible legislative and regulatory policies that drive innovation, increase funding for research, and enhance access and coverage for prescription psychedelic medicine. Learn more at psychedelicsRX.org.
SOURCE Association for Prescription Psychedelics
MomsSpaghetti
3日前
MindMed Appoints Gregg Pratt, Ph.D. as Chief Regulatory and Quality Assurance Officer
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 the appointment of Gregg A. Pratt, Ph.D., as Chief Regulatory and Quality Assurance Officer. Dr. Pratt will serve as a member of the Executive Committee and oversee the Company’s regulatory and quality functions, as well as its product registration strategies.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20241118653031/en/
“We are thrilled to welcome Gregg to the MindMed team. His leadership will strengthen our capabilities and accelerate our progress as we prepare to launch three Phase 3 studies of MM120 orally disintegrating tablet (ODT) in generalized anxiety disorder (GAD) and major depressive disorder (MDD),” said Rob Barrow, Chief Executive Officer of MindMed. “Gregg’s deep expertise in leading the regulatory approvals of transformative psychiatric drugs—demonstrated by his recent leadership in the approval of the first novel schizophrenia treatment in decades—will be key as we advance our Phase 3 programs. His appointment also reflects our strong commitment to clinical and regulatory excellence as we aim for two potential approvals in the coming years and work to transform the treatment of brain health disorders.”
“The therapeutic potential of MM120 ODT, as demonstrated in the Phase 2b study results, inspired me to join MindMed in pursuing what could be one of the most meaningful breakthroughs in the field of psychiatry,” said Dr. Pratt. “With our Phase 3 trial initiations imminent, I am eager to collaborate with the team to ensure our regulatory approach supports continued execution of the Company’s strategy and, if approved, to deliver MM120 ODT as a novel, much-needed therapy for millions of patients living with GAD and MDD.”
Dr. Pratt brings more than three decades of experience in drug development, registration, and commercialization, with a distinguished career spanning multiple therapeutic areas including psychiatry, neurology, and cardiology. Dr. Pratt joins MindMed from Karuna Therapeutics, which Bristol Myers Squibb acquired in March 2024. At Karuna, he served as Senior Vice President of Regulatory Affairs and Quality Assurance, where he oversaw the regulatory submission and ultimate approval by the U.S. Food and Drug Administration of COBENFY™, the first product in four decades with a novel mechanism of action in schizophrenia. Before joining Karuna Therapeutics, Dr. Pratt held leadership positions at Lundbeck, Abbvie, Solvay, Collegium, Baxter, and Assertio Therapeutics, where he led regulatory affairs in drug, biologic, and combination product development strategies, as well as registration maintenance for approved products in global markets. Dr. Pratt has a Ph.D. in chemistry from West Virginia University and a Bachelor of Science degree from the University of Wyoming.
Inducement Grants under Nasdaq Listing Rule 5635(c)(4)
In connection with his appointment as Chief Regulatory and Quality Assurance Officer, MindMed granted Dr. Pratt an inducement award consisting of an option to purchase an aggregate of 350,000 common shares of the Company (the "Option"), with an effective grant date of November 18, 2024. The Option has an exercise price equal to the closing price of MindMed’s common shares on November 15, 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 the first anniversary and the remaining 75% vesting in 36 equal monthly installments over the next three-year period thereafter, subject to his continued employment.
The inducement award to Dr. Pratt was granted as a material inducement to his employment and was approved by MindMed's Compensation Committee on August 31, 2024, in accordance with Rule 5635(c)(4) of The NASDAQ Stock Market LLC. The award was granted outside MindMed's equity incentive plans.
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.
MomsSpaghetti
7日前
Commodore Capital now owns 9.9% of MindMed $MNMD
Total owned shares are 8,176,721
https://ir.stockpr.com/mindmed/sec-filings-email/content/0001493152-24-045841/formsc13ga.htm
Commodore Capital is a healthcare investment firm. We use a science-driven approach to invest in innovative companies that are developing medical products to meaningfully improve patients’ lives. The fund is designed to make long term investments in small-cap public and late-stage private biopharmaceutical companies.
They have achieved notable success with several investments in the biopharmaceutical sector. One significant win was their investment in BELLUS Health Inc., a biopharmaceutical company specializing in treatments for chronic cough and other hypersensitization disorders. Commodore Capital held approximately 5,128,557 shares of BELLUS Health, valued at $54.2 million, representing 8.7% of their portfolio as of November 2022.
Wallmine Notes for BELLUS
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In April 2023, BELLUS Health was acquired by GSK plc for $2 billion, a substantial premium over its market value at the time. This acquisition likely resulted in a significant return on investment for Commodore Capital, given their substantial stake in BELLUS Health prior to the acquisition.
Another notable investment is Cogent Biosciences, a biotechnology company developing precision therapies for genetically defined diseases. Commodore Capital's stake in Cogent Biosciences was valued at $64.5 million, making up 10.4% of their portfolio as of November 2022.
Wallmine Notes for Cogent
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While specific financial outcomes are not detailed, the substantial allocation suggests a strong performance and confidence in the company's prospects. These investments underscore Commodore Capital's strategic focus on identifying and supporting promising healthcare companies, leading to significant returns in the sector.
MomsSpaghetti
2週前
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/home/20241107702200/en/MindMed-Reports-Third-Quarter-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”
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“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.
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