Latest news with #MM120
Globe and Mail
27-05-2025
- Business
- Globe and Mail
MindMed Strengthens Executive Team with Appointment of Brandi Roberts, CPA, as Chief Financial Officer
Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (the "Company" or "MindMed"), a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced the appointment of Brandi L. Roberts as its Chief Financial Officer (CFO), effective June 2, 2025. In her new role, Ms. Roberts will join MindMed's executive leadership team where she will oversee all aspects of financial strategy, capital planning, accounting, investor relations and information technology as the Company advances its clinical development and commercial priorities for its lead product candidate MM120 orally disintegrating tablet (ODT) for generalized anxiety disorder (GAD) and major depressive disorder (MDD). This press release features multimedia. View the full release here: 'Brandi joins MindMed at a pivotal moment for the company, bringing with her a powerful combination of financial acumen, strategic vision, and deep biotech sector expertise,' said Rob Barrow, Chief Executive Officer of MindMed. 'Her proven track record leading public companies through transformative milestones, including initial public offerings (IPO), business development and investor engagement makes her a valuable addition to our organization. As we accelerate toward the potential commercialization of MM120 ODT, her understanding of the healthcare landscape and executional strength will be instrumental in advancing our strategy, driving growth, and delivering long-term value for both patients and shareholders.' 'MindMed is leading a true paradigm shift in mental health treatment, and I'm excited to collaborate with a team renowned for its exceptional depth and breadth of experience in drug development,' said Ms. Roberts. 'With MM120 ODT, the company is advancing a potential breakthrough for the millions of people in the U.S. suffering from GAD and MDD. Joining MindMed is an extraordinary opportunity to continue building a robust financial infrastructure that matches the strength of the Company's science; delivering a comprehensive strategic financial vision built to support innovation, agility, and access with the goal of helping patients and making a meaningful impact in addressing the mental health crisis.' Ms. Roberts has more than 25 years of financial leadership experience within the life sciences industry. Most recently, she served as CFO and Executive Vice President of Longboard Pharmaceuticals, where she helped lead the company through its IPO, multiple financings, and ultimately, its $2.6 billion acquisition by Lundbeck in 2024. Throughout her career, Ms. Roberts has played pivotal roles in scaling operations, supporting clinical development, and managing investor relations with leading investors, funds, and analysts. She has held CFO roles at Lineage Cell Therapeutics, REVA Medical, and Mast Therapeutics, and senior finance positions at Alphatec Spine, Inc., Artes Medical, Inc., Stratagene Corporation, and Pfizer, Inc. Ms. Roberts received her MBA from the University of San Diego and her B.S. degree in business administration in Accounting and Finance from the University of Arizona. She is a Certified Public Accountant in the State of California and currently serves on the board of advisors for Life Science Cares San Diego and the board for the Association of Bioscience Financial Officers Southwest chapter. Inducement Grants under Nasdaq Listing Rule 5635(c)(4) In connection with her appointment as Chief Financial Officer on June 2, 2025, MindMed will grant Ms. Roberts on such date inducement awards consisting of (i) an option to purchase 500,000 common shares of the Company (the "Option") and (ii) 125,000 performance share units (the 'PSUs') (assuming achievement at target levels of performance) that, if earned, will be settled in MindMed common shares upon vesting. The Option will have an exercise price equal to the closing price of MindMed's common shares on May 30, 2025, the last trading day on which MindMed's common shares will trade 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 three-year period thereafter, subject to her continued employment. The PSUs will vest on the third anniversary of the grant date, subject to continued service through the vesting date. Actual earned PSUs can range from 0%-200% of the target number of PSUs and will be based on the achievement of certain performance metrics as measured at the end of the three-year performance period. The inducement awards to Ms. Roberts will be granted as a material inducement to her entering into employment with MindMed and were approved by MindMed's Compensation Committee on May 21, 2025, in accordance with Rule 5635(c)(4) of The NASDAQ Stock Market LLC. The awards were granted outside MindMed's equity incentive plans. About MindMed MindMed is a late-stage clinical 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. Forward-Looking Statements 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 the Company's beliefs regarding potential benefits of MM120 ODT for GAD and MDD; the size of the addressable market for MM120 ODT for treatment of GAD and MDD; the Company's plans to appoint Ms. Roberts as CFO effective June 2, 2025, and to grant her inducements awards in connection therewith. 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; compliance with laws and regulations; legislative and regulatory developments, including decisions by the Drug Enforcement Administration and states to reschedule any of our product candidates, if approved, containing Schedule I controlled substances, before they may be legally marketed in the U.S.; difficulty associated with research and development; risks associated with clinical studies or studies; heightened regulatory scrutiny; early stage product development; clinical study risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; ability to maintain effective patent rights and other intellectual property protection; as well as those risk factors discussed or referred to herein and the risks, uncertainties and other factors described in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and the Company's Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2025 under headings such as "Special Note Regarding Forward-Looking Statements," and "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 and with the U.S. Securities and Exchange Commission on EDGAR at 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.
Business Wire
27-05-2025
- Business
- Business Wire
MindMed Strengthens Executive Team with Appointment of Brandi Roberts, CPA, as Chief Financial Officer
NEW YORK--(BUSINESS WIRE)--Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (the "Company" or "MindMed"), a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced the appointment of Brandi L. Roberts as its Chief Financial Officer (CFO), effective June 2, 2025. In her new role, Ms. Roberts will join MindMed's executive leadership team where she will oversee all aspects of financial strategy, capital planning, accounting, investor relations and information technology as the Company advances its clinical development and commercial priorities for its lead product candidate MM120 orally disintegrating tablet (ODT) for generalized anxiety disorder (GAD) and major depressive disorder (MDD). 'Brandi joins MindMed at a pivotal moment for the company, bringing with her a powerful combination of financial acumen, strategic vision, and deep biotech sector expertise,' said Rob Barrow, Chief Executive Officer of MindMed. 'Her proven track record leading public companies through transformative milestones, including initial public offerings (IPO), business development and investor engagement makes her a valuable addition to our organization. As we accelerate toward the potential commercialization of MM120 ODT, her understanding of the healthcare landscape and executional strength will be instrumental in advancing our strategy, driving growth, and delivering long-term value for both patients and shareholders.' 'MindMed is leading a true paradigm shift in mental health treatment, and I'm excited to collaborate with a team renowned for its exceptional depth and breadth of experience in drug development,' said Ms. Roberts. 'With MM120 ODT, the company is advancing a potential breakthrough for the millions of people in the U.S. suffering from GAD and MDD. Joining MindMed is an extraordinary opportunity to continue building a robust financial infrastructure that matches the strength of the Company's science; delivering a comprehensive strategic financial vision built to support innovation, agility, and access with the goal of helping patients and making a meaningful impact in addressing the mental health crisis.' Ms. Roberts has more than 25 years of financial leadership experience within the life sciences industry. Most recently, she served as CFO and Executive Vice President of Longboard Pharmaceuticals, where she helped lead the company through its IPO, multiple financings, and ultimately, its $2.6 billion acquisition by Lundbeck in 2024. Throughout her career, Ms. Roberts has played pivotal roles in scaling operations, supporting clinical development, and managing investor relations with leading investors, funds, and analysts. She has held CFO roles at Lineage Cell Therapeutics, REVA Medical, and Mast Therapeutics, and senior finance positions at Alphatec Spine, Inc., Artes Medical, Inc., Stratagene Corporation, and Pfizer, Inc. Ms. Roberts received her MBA from the University of San Diego and her B.S. degree in business administration in Accounting and Finance from the University of Arizona. She is a Certified Public Accountant in the State of California and currently serves on the board of advisors for Life Science Cares San Diego and the board for the Association of Bioscience Financial Officers Southwest chapter. Inducement Grants under Nasdaq Listing Rule 5635(c)(4) In connection with her appointment as Chief Financial Officer on June 2, 2025, MindMed will grant Ms. Roberts on such date inducement awards consisting of (i) an option to purchase 500,000 common shares of the Company (the "Option") and (ii) 125,000 performance share units (the 'PSUs') (assuming achievement at target levels of performance) that, if earned, will be settled in MindMed common shares upon vesting. The Option will have an exercise price equal to the closing price of MindMed's common shares on May 30, 2025, the last trading day on which MindMed's common shares will trade 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 three-year period thereafter, subject to her continued employment. The PSUs will vest on the third anniversary of the grant date, subject to continued service through the vesting date. Actual earned PSUs can range from 0%-200% of the target number of PSUs and will be based on the achievement of certain performance metrics as measured at the end of the three-year performance period. The inducement awards to Ms. Roberts will be granted as a material inducement to her entering into employment with MindMed and were approved by MindMed's Compensation Committee on May 21, 2025, in accordance with Rule 5635(c)(4) of The NASDAQ Stock Market LLC. The awards were granted outside MindMed's equity incentive plans. About MindMed MindMed is a late-stage clinical 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. Forward-Looking Statements 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 the Company's beliefs regarding potential benefits of MM120 ODT for GAD and MDD; the size of the addressable market for MM120 ODT for treatment of GAD and MDD; the Company's plans to appoint Ms. Roberts as CFO effective June 2, 2025, and to grant her inducements awards in connection therewith. 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; compliance with laws and regulations;legislative and regulatory developments, including decisions by the Drug Enforcement Administration and states to reschedule any of our product candidates, if approved, containing Schedule I controlled substances, before they may be legally marketed in the U.S.; difficulty associated with research and development; risks associated with clinical studies or studies; heightened regulatory scrutiny; early stage product development; clinical study risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; ability to maintain effective patent rights and other intellectual property protection; as well as those risk factors discussed or referred to herein and the risks, uncertainties and other factors described in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and the Company's Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2025 under headings such as "Special Note Regarding Forward-Looking Statements," and "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 and with the U.S. Securities and Exchange Commission on EDGAR at 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.
Yahoo
21-05-2025
- Business
- Yahoo
Mind Medicine (MindMed) Inc. (MNMD): Analysts See 285% Upside Potential
We recently published an article titled . Mind Medicine (MindMed) Inc. (NASDAQ:MNMD) was one of the stocks that was covered in that article. Wall Street analysts believe MNMD has a 285% upside potential over the next 12 months. A biopharmaceutical researcher proficiently using laboratory instruments. Mind Medicine (MindMed) Inc. (NASDAQ:MNMD) is a clinical-stage biopharmaceutical company dedicated to pioneering innovative treatments for brain health disorders. With a focus on addressing the therapeutic needs of patients suffering from anxiety, depression, autism spectrum disorders, and other severe mental health challenges, MindMed explores the promising potential of psychedelics and other compounds. The company's approach is rooted in cutting-edge research, aiming to develop transformative solutions that improve patients' quality of life by targeting the underlying mechanisms of these disorders. A key candidate in MindMed's pipeline is MM120, a proprietary form of lysergide D-tartrate. This compound has gained considerable attention for its potential efficacy in treating generalized anxiety disorder (GAD) and major depressive disorder (MDD). Currently in Phase 3 clinical trials, MM120 has shown remarkable promise in addressing symptoms of anxiety and depression. Preliminary results from earlier trials indicate a rapid onset of therapeutic effects, with the benefits enduring for at least 12 weeks without requiring adjunct psychotherapy. This durability and reliability have positioned MM120 as a groundbreaking candidate in the realm of mental health treatments. MindMed's financial stability bolsters its ability to advance clinical programs efficiently. The company reported a strong cash position of $273 million, ensuring a robust financial runway to sustain operations and progress its trials. During the first quarter of 2025, CEO Rob Barrow reaffirmed MindMed's commitment to furthering its clinical programs, specifically emphasizing the pivotal Phase 3 trials for MM120 ODT. These trials, named Voyage, Panorama, and Emerge, are strategically designed to refine the therapeutic applications of MM120, aiming to deliver comprehensive solutions for GAD and MDD. Top-line results from these trials are eagerly anticipated by 2026, which could mark a significant milestone in the field of mental health treatment. With a solid cash balance of $245.5 million as of March 31, 2025, MindMed remains well-equipped to operationally sustain its progress through 2027. Analysts on Wall Street have expressed optimism regarding the company's growth trajectory, projecting a twelve-month average share price of $24.50, offering an upside potential of 291.37%. Overall, Mind Medicine (MindMed) Inc. (NASDAQ:MNMD) ranks 8th on our list of 13 Best Multibagger Stocks to Invest in Now. While we acknowledge the potential of MNMD to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than MNMD and that has 100x upside potential, check out our report about this cheapest AI stock. READ NEXT: 10 Best Low Volatility Stocks to Buy Now and Starter Stock Portfolio: 12 Safe Stocks to Buy Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
National Post
08-05-2025
- Business
- National Post
MindMed Reports First Quarter 2025 Financial Results and Recent Business Updates
Article content –Dosed first patient in Emerge, the first Phase 3 study of MM120 Orally Disintegrating Tablet (ODT) in Major Depressive Disorder (MDD); 12-week topline data anticipated in 2H 2026– Article content Article content –Enrollment on track in Phase 3 Voyage and Panorama studies of MM120 (ODT) in Generalized Anxiety Disorder (GAD); 12-week topline data anticipated in 1H 2026 for Voyage and 2H 2026 for Panorama– Article content –Company to host a conference call today at 8:00 a.m. EDT– Article content NEW YORK — Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (the 'Company' or 'MindMed'), a late-stage clinical biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced its first quarter 2025 financial results and provided an update on business highlights. 'We are proud to share that all three of our pivotal Phase 3 trials evaluating MM120 ODT in patients with GAD and MDD—Voyage, Panorama, and Emerge—are actively enrolling. Momentum is building, with strong and growing enthusiasm from both clinical sites and patients as recruitment continues to accelerate,' said Rob Barrow, Chief Executive Officer of MindMed. 'We're on track to report topline data from Voyage in the first half of 2026, followed by Panorama and Emerge in the second half of the year. With our breakthrough therapy designation in GAD, a clearly defined regulatory strategy, and strong operational execution across our programs, we're delivering on our goal of advancing MM120 ODT as a potential best-in-class, differentiated therapeutic option. Our team remains fully committed to delivering transformational innovation for the over 50 million people in the U.S. living with GAD or MDD as we drive toward commercialization.' Article content Initiated dosing in the Phase 3 Emerge study of MM120 ODT for the treatment of MDD in April 2025. Topline data from the 12-week double-blind period (Part A) is anticipated in the second half of 2026. Appointed Matt Wiley as Chief Commercial Officer, adding deep commercial expertise to the executive leadership team. With more than 25 years of experience in sales, marketing and strategic leadership, including multiple specialty product launches focused on central nervous system disorders and psychiatry, Mr. Wiley will lead global commercial strategy and execution to drive the next phase of growth. In April, amended the Company's loan agreement with K2 HealthVentures to provide greater financial flexibility and optionality. The amended agreement provides the Company with up to $120 million based on the achievement of certain milestones and extends the interest only period through at least May 1, 2027. The Company received approximately $17.8 million in net cash at closing, after refinancing in full all term loans outstanding under the original agreement, and the payment of fees and expenses in connection with the amendment and the refinancing of the existing term loans. Article content Enrollment is on track in the Phase 3 Voyage study of MM120 ODT for the treatment of GAD. Voyage is expected to enroll approximately 200 participants in the U.S. who will be randomized 1:1 to receive MM120 ODT 100 µg or placebo. Topline data from the 12-week double-blind period (Part A) is anticipated in the first half of 2026. Enrollment is on track in the second Phase 3 Panorama study of MM120 ODT for the treatment of GAD. Panorama is expected to enroll approximately 250 participants (randomized 2:1:2 to receive MM120 ODT 100 µg, MM120 ODT 50 µg or placebo) in the U.S. and Europe. Topline data from the 12-week double-blind period (Part A) is anticipated in the second half of 2026. Article content Enrollment is on track in the Phase 3 Emerge study of MM120 ODT for the treatment of MDD. Emerge is expected to enroll 140 participants (randomized 1:1 to receive MM120 ODT 100 µg or placebo). Topline data from the 12-week double-blinded period (Part A) is anticipated 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 discussions. Article content Completed a Phase 1 study of MM402, a single-ascending dose study in adult healthy volunteers. The study characterized the tolerability, pharmacokinetics and pharmacodynamics of MM402. The Company expects to initiate further studies of MM402 to assess its potential efficacy for the treatment of ASD. Article content Cash, Cash Equivalents and Investments totaled $245.5 million as of March 31, 2025. The Company believes that its cash, cash equivalents, and investments as of March 31, 2025, 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. Article content Research and Development (R&D) expenses were $23.4 million for the three months ended March 31, 2025, compared to $11.7 million for the three months ended March 31, 2024, an increase of $11.7 million. The increase was primarily due to $9.4 million in expenses related to the Company's MM120 ODT program, an increase of $2.4 million in internal personnel costs as a result of increasing R&D capacities, and an increase of $0.1 million in preclinical and other program expenses, partially offset by a decrease of $0.2 million in MM402 program expenses. Article content General and Administrative expenses were $8.8 million for the three months ended March 31, 2025, compared to $10.5 million for the three months ended March 31, 2024, a decrease of $1.7 million. The decrease was primarily attributable to stock-based compensation expense. Article content MindMed management will host a webcast at 8:00 AM EDT today to provide a corporate update and review the Company's first quarter 2025 financial results and business highlights. Listeners can register for the webcast via 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, 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. Article content About MM120 Orally Disintegrating Tablet (ODT) Article content MM120 ODT (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-HT2A) receptors. MM120 ODT is MindMed's proprietary and pharmaceutically optimized form of LSD. MM120 ODT is an advanced formulation incorporating Catalent's Zydis® ODT fast-dissolve technology which has a unique clinical profile with more rapid absorption, improved bioavailability and reduced gastrointestinal side effects. MindMed is developing MM120, the tartrate salt form of lysergide, for generalized anxiety disorder (GAD), major depressive disorder (MDD), and is exploring its potential applications in other serious brain health disorders. Article content About MM402 Article content MM402 is the Company's proprietary form of R(-)-MDMA (rectus-3,4-methylenedioxymethamphetamine), being developed for the treatment of core symptoms of Autism Spectrum Disorder (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. Article content About MindMed Article content MindMed is a late-stage clinical 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. Article content Forward-Looking Statements Article content 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 is 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 the Company's anticipated topline readout (Part A results) for the Phase 3 Voyage study of MM120 ODT in GAD in the first half of 2026; the Company's anticipated topline readout (Part A results) for the Phase 3 Panorama study for MM120 ODT in GAD in the second half of 2026; the Company's anticipated topline readout (Part A results) for the Phase 3 Emerge study for MM120 ODT in MDD in the second half of 2026; the Company's plans to conduct a second Phase 3 study in MDD; the Company's expectations regarding the enrollment for each of the Voyage, Panorama and Emerge studies; the Company's beliefs regarding potential benefits of its product candidates; the Company's expectation to conduct further studies of MM402; the Company's expectation that its cash and cash equivalents will fund operations into 2027; the Company's expectation that its cash runway will extend at least 12 months beyond its first Phase 3 topline data readout for MM120 ODT in GAD; and potential additional indications for MM120 ODT and MM402. 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; compliance with laws and regulations; legislative and regulatory developments, including decisions by the Drug Enforcement Administration and states to reschedule any of our product candidates, if approved, containing Schedule I controlled substances, before they may be legally marketed in the U.S.; difficulty associated with research and development; risks associated with clinical studies or studies; heightened regulatory scrutiny; early stage product development; clinical study risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; ability to maintain effective patent rights and other intellectual property protection; as well as those risk factors discussed or referred to herein and the risks, uncertainties or other factors described in the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2023 and the Company's Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2025 under headings such as 'Special Note Regarding Forward-Looking Statements,' and '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 and with the U.S. Securities and Exchange Commission on EDGAR at 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. Article content Article content Article content Article content Article content Article content
Medscape
07-05-2025
- Health
- Medscape
LSD for Anxiety and Depression: Worth the Trip?
A year after the US Food and Drug Administration (FDA) opened the door to clinical use of lysergic acid diethylamide (LSD), US-based MindMed has launched phase 3 trials in the United States and Europe of MM120 (lysergide d-tartrate) for the treatment of generalized anxiety disorder (GAD) and major depressive disorder (MDD). The trials are testing the company's 100-mcg orally disintegrating tablet MM120, which received FDA Breakthrough Therapy based on results from a phase 2B trial in GAD. In that study, one dose of the drug was associated with rates of 65% for clinical response and 48% for clinical remission at 12 weeks. 'It's unprecedented in psychiatry,' investigator Daniel R. Karlin, MD, psychiatrist and chief medical officer of MindMed, said during a presentation at the European Psychiatric Association Congress (EPA) 2025. Compared with traditional psychopharmacologic therapy, the drug's effect can be measured as early as 1 day after treatment, he added. Successful phase 3 results could put MM120 in line to become the first FDA-approved psychedelic drug. What does the research show and what hurdles must the drug clear to make it to market? How Does It Work? Most experts agree that the mechanism of action of LSD remains somewhat of a mystery. What is known is that all psychedelic drugs bind to the 5-HT 2A receptor, a subtype of the serotonin receptor that plays a role in cognition, mood, perception, and other psychological processes. That binding 'seems to start a cascade of events changing how brain networks connect,' Jerrold Rosenbaum, MD, psychiatrist-in-chief emeritus and director of the Center for the Neuroscience of Psychedelics, Massachusetts General Hospital, and professor of psychiatry at Harvard Medical School, both in Boston, told Medscape Medical News . The resulting surge in synapse and neuronal growth creates neuroplasticity, 'potentially reopening critical periods for learning, and then maybe the emotional and spiritual experience,' he said. Karlin explained it as changing the brain's filter. 'If I were to tell you that I knew reliably why LSD makes people feel better the way that it does, I'd be making it up,' he said. 'People under the influence of so-called hallucinogens really aren't hallucinating. What's happening is the organizing principles that underlie their ability to perceive the world in the usual way are turned down or all the way off, and the world becomes a complicated, confusing mix of lights and colors and sounds, sounds perceived as colors, taste perceived as sound. It's the loss of organization,' he added. The result is a rearrangement of an individual's relationship with anxiety and depression, he noted. 'We have thought for a long time about psychiatric drugs in terms of symptom suppression. What we really haven't thought about is the potential for psychiatric meds, particularly in anxiety, to enhance the view of the future. It's not about feeling less overall — therefore, less anxiety — it's just feeling differently about life and about the prospects of the future,' Karlin said. Is MM120 Effective? While none of the clinical research on MM120 to date has been published in peer-reviewed journals, findings have been presented at various scientific congresses. The phase 2b dose optimization study that prompted the FDA's Breakthrough Therapy designation included 198 participants with GAD who were randomized to receive either a single administration of MM120 at a dose of 25 mcg (n = 39), 50 mcg (n = 40), 100 mcg (n = 40), or 200 mcg (n = 40) or placebo (n = 39). The primary endpoint was a change from baseline in the Hamilton Anxiety Rating Scale (HAM-A) scores. MM120 at doses of 100 and 200 mcg demonstrated a statistically significant dose-response relationship at both 4 and 8 weeks. The estimated minimally efficacious dose to be between 56.7 and 85.1 mcg. At 12 weeks, the 100-mcg dose was associated with a 65% clinical response and a 48% clinical remission based on HAM-A scores compared with 30.8% and 20.5%, respectively, in the placebo group. Secondary outcomes showed a clinically meaningful change compared with placebo in the Montgomery-Åsberg Depression Rating Scale (MADRS), Clinical Global Impression-Severity, and Patient Global Impression-Severity scores from baseline to weeks 1, 2, 4, 8, and 12. A separate evaluation of this study also measured the ability of independent clinicians known as 'central raters' (CRs) to remain blinded to whether a participant was receiving placebo or active study drug. Findings suggested the majority of CRs remained blinded, demonstrating that study results were protected from functional unblinding. A third evaluation of the same study looked at functional disability, health-related quality of life, sleep quality, and sexual dysfunction in study participants across the five dosing arms and showed clinically meaningful improvements associated with the two higher doses as early as 1 week post-treatment and through the 12-week follow-up. Based on these results, MindMed has launched three phase 3 double-blind, randomized clinical trials to study the MM120 efficacy for GAD and MDD. The two GAD studies, Voyage and Panorama, are expected to enroll approximately 200 US participants and 250 US and European participants, respectively. Voyage will compare the 100-mcg MM120 dose with placebo on a primary endpoint of HAM-A scores at 12 weeks, followed by a 40-week extension phase with the opportunity for four open-label doses looking at safety, as well as time to and response to re-treatment. Panorama will be identical except for including a third 50 mcg 'blinding control' arm, said Karlin. The MDD trial, Emerge, is expected to enroll approximately 140 US participants and will compare the 100-mcg MM120 dose with placebo. For this trial, the primary endpoint is MADRS scores at 12 weeks, followed by a 40-week extension phase with the opportunity for four open-label doses looking at MADRS scores and the Patient Health Questionnaire for depression. 'Progress in Emerge and additional regulatory discussions will inform the design and timing of a second phase 3 study in MDD,' according to the company website. What About Safety? Safety data from early MM120 trials showed no increase in suicidal ideation, and there were minimal side effects, mostly on the day of treatment, said Karlin. The most frequent adverse events in patients in the therapeutic (100 mcg) dosing arm were illusion, reported by 60% of participants, and nausea, which affected 40%. Other side effects included euphoric mood, headache, visual hallucination, hyperhidrosis, mydriasis, altered state of consciousness, anxiety, increased blood pressure, and abnormal thinking. The frequency of these adverse events ranged from 10% to 27.5%. 'I think the reported effects are quite consistent with what a full dose LSD experience would induce. Illusions, visual hallucinations, and altered state of consciousness for someone choosing an LSD experience would likely be considered desirable, but as a therapeutic for anxiety are registered as adverse effects,' Rosenbaum said. Additionally, there are a number of known and potential harms associated with LSD use, noted Rosenbaum, who co-authored a recent review on the potential for both healing and harm. In addition to the uncommon risk for acute or long-term cardiovascular effects, some individuals have reported ongoing perceptual disturbances, including flashbacks and visual trails triggered by moving objects, he noted. 'A small percentage of people who are vulnerable, let's say, to bipolar, mania, schizophrenia, or other psychotic disorders, may be triggered by psychedelics. Others may have a terrifying and challenging experience which is traumatic itself,' he said. Hurdles to FDA Approval? Last year's FDA rejection of Lykos Therapeutics' application for midomafetamine with assisted therapy (MDMA-AT) to treat posttraumatic stress disorder was disappointing, but it doesn't necessarily mean an uphill battle for other psychoactive drugs in the pipeline, said Rosenbaum, who was a consultant for Lykos. One problem the agency noted was functional unblinding in the trials — the inability to blind participants to whether they were taking a placebo or active drug. MindMed has also made efforts to address this potential barrier with MM120 with its assessment of CRs. The Panorama trial, which has just launched, includes two LSD arms (a therapeutic dose of 100 mcg and a subtherapeutic dose of 50 mcg) plus placebo. 'The 50 mcg arm isn't of analytic interest — in the dose range finding study 50 mcg was actually the least active dose,' said Karlin. 'But it is to confound the belief of people who got 100 mcg that they got the active dose of drug.' Although Rosenbaum believes blinding in psychedelic studies is virtually impossible because 'a psychedelic experience is pretty obvious,' he and other experts in the field don't expect this to be a barrier because the FDA has overlooked this in other successful psychotropic drug applications, such as esketamine. Another problem cited in Lykos' trials was a lack of evidence to demonstrate the therapy was effective without psychotherapy assistance. 'Pairing the compound with psychotherapy was confusing things, making it harder to study and raising questions, when the FDA said, 'we don't regulate therapy,'' Rosenbaum said, referring to Lykos' MDMA compound. In early MM120 trials, patients were monitored by clinical staff through an approximately 8-hour treatment session, but there was no psychotherapy component, explained Karlin. If MindMed is successful in its application for FDA approval, one last hurdle would remain. LSD is currently classified as a schedule 1 drug under the Controlled Substances Act, making its use illegal. The US Drug Enforcement Agency would have to reschedule LSD before MM120 could be prescribed. The rescheduling process is lengthy, and the outcome is uncertain. Should Psychotherapy Play a Role? Some experts question the movement toward psychedelics as stand-alone treatment, without accompanying psychotherapy. 'Psychotherapy is as essential as pharmacological treatment in managing mental disorders, particularly in the context of psychedelic therapies,' Gabriella Gobbi, MD, PhD, professor of psychiatry at McGill University, Montreal, Quebec, Canada, told Medscape Medical News . 'The mechanisms of therapeutic action of psychedelics are not entirely dependent on neurobiology, such as receptor interactions and the activation of specific brain circuits, but also rely significantly on psychological, social, and spiritual processes,' noted Gobbi, who also is president-elect of The International College of Neuropsychopharmacology. 'For these reasons, physicians or psychotherapists involved in psychedelic-assisted psychotherapy r equire specialized training to accompany patients through this experience to enhance positive outcomes and address potential side effects.' Rosenbaum does not dispute that patients need support during their psychedelic treatment session, but in his opinion, psychotherapy is not realistic. 'You can't do therapy during a psychedelic experience. You can do hand holding, you can do monitoring, you can encourage people to stay within the treatment, and you can rescue them if they're having a challenging experience. But it's not therapy,' he said. Current FDA requirements for clinical trials call for the presence of two monitors when a patient is under the effects of a psychedelic. The lead monitor must be a licensed clinician with graduate-level professional training and clinical experience in psychotherapy. The second monitor must hold a bachelor's degree and at least 1 year of clinical experience in a licensed mental health care setting. If the FDA were to approve a psychedelic therapy, it is unclear if the agency would impose similar requirements. 'We don't think that this is moving in a direction where you don't need a monitor, but could it be one monitor? That's something we'll have to figure out,' Karlin said. 'If it can be done safely and effectively, and certainly there's precedent for that in the Swiss use of the drug. There's precedent for that in the way that [esketamine] is being used in the US and worldwide.' Rosenbaum reported holding stock or equity in Atai Life Sciences, Cerebral Inc., Entheos Labs, Psy Therapeutics, Sensorium Therapeutics, Tara Mind Inc., and Terran Biosciences; being a member of the board of directors for Cerebral Inc., Entheos Labs, Psy Therapeutics, and Sensorium Therapeutics; and being an advisor for Tara Mind Inc. and Reunion Neuroscience. Gobbi reported receiving funds from Diamond Therapeutics Inc. and being the inventor of a pending patent on the use of LSD.
