Latest news with #MM120
National Post
31-07-2025
- Business
- National Post
MindMed Reports Q2 2025 Financial Results and Business Updates
Article content –Strong enrollment continues in all three Phase 3 trials of MM120 Orally Disintegrating Tablet (ODT) in Generalized Anxiety Disorder (GAD) and Major Depressive Disorder (MDD)– Article content –Data from the Phase 3 Voyage trial in GAD anticipated in 1H 2026 and data from the Phase 3 Panorama trial in GAD and Phase 3 Emerge trial in MDD anticipated in 2H 2026– Article content Article content –Strengthened leadership team with appointment of Brandi L. Roberts as Chief Financial Officer– Article content –Conference call scheduled today at 4:30 p.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 second quarter 2025 financial results and provided an update on business highlights. 'We continue making significant progress across all three of our pivotal Phase 3 trials evaluating MM120 ODT in GAD and MDD, with ongoing enthusiasm from both trial sites and participants driving strong enrollment,' said Rob Barrow, Chief Executive Officer of MindMed. 'We remain on track to report topline data from our Phase 3 Voyage trial in the first half of 2026, followed by Panorama and Emerge in the second half of the year. In parallel, we are advancing our commercial strategy and have continued to strengthen our leadership team with the appointment of Brandi Roberts as Chief Financial Officer. With our clearly defined regulatory strategy, disciplined operational execution, and strong balance sheet, we are well-positioned to advance MM120 ODT as a potential best-in-class therapeutic option for the treatment of GAD and MDD.' Article content Business Highlights Article content Progressing Pivotal Trials: Strong enrollment continues across all three MM120 ODT Phase 3 trials: Voyage and Panorama in GAD and Emerge in MDD. The continued execution reinforces the Company's targeted trial timelines and progress in preparing for a potential NDA filing. Strengthened Leadership for Growth: Appointed Brandi L. Roberts as Chief Financial Officer. Ms. Roberts brings more than 25 years of financial leadership experience within the life sciences industry. As a member of the executive team, she leads all aspects of the Company's financial strategy, capital planning, accounting, investor relations and information technology. Article content MM120 ODT (lysergide D-tartrate) for GAD 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 Panorama study, the Company's second Phase 3 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 MM120 (lysergide D-tartrate) for MDD Article content Enrollment is on track in the Phase 3 Emerge study of M120 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 MM402 (R(-)-MDMA) for Autism Spectrum Disorder (ASD) 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 Balance. Article content As of June 30, 2025, MindMed had cash, cash equivalents and investments totaling $237.9 million compared to $245.5 million as of March 31, 2025. Article content Based on the Company's current operating plan and anticipated R&D milestones, the Company believes that its cash, cash equivalents and investments as of June 30, 2025 will be sufficient to fund the Company's operations into 2027 and at least 12 months beyond its first Phase 3 topline data readout for MM120 ODT in GAD. Article content Research and Development (R&D). Article content R&D expenses were $29.8 million for the quarter ended June 30, 2025, compared to $14.6 million for the quarter ended June 30, 2024, an increase of $15.2 million. The net increase of $15.2 million was primarily related to increases of $14.5 million related to our MM120 ODT program, $1.5 million in internal personnel costs as a result of increased headcount, and $0.2 million related to preclinical activities, offset by a decrease of $1.0 million in MM402 program expenses based on the timing of studies. Article content General and Administrative (G&A). Article content G&A expenses were $11.1 million for the quarter ended June 30, 2025, compared to $9.8 million for the quarter ended June 30, 2024, an increase of $1.3 million. The increase was primarily related to increases in personnel costs as a result of increased headcount. Article content Net Loss. Article content Net loss for the quarter ended June 30, 2025, was $42.7 million, compared to $5.9 million for the same period in 2024, a decrease of $36.8 million. The decrease was primarily due to increases in operating expenses of $16.4 million, changes in the fair value of warrants issued in our September 2022 underwritten offering of $15.6 million, the absence of a $2.5 million gain on extinguishment of contribution payable from 2024 and increased interest expense related primarily to the amendment of our credit facility of $1.8 million. Article content Conference Call and Webcast Reminder Article content MindMed management will host a webcast at 4:30 p.m. EDT today to provide a corporate update and review the Company's second quarter 2025 financial results, and business highlights. 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, 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 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 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, cash equivalents and investments 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 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. Article content Mind Medicine (MindMed) Inc. Consolidated Statements of Operations and Comprehensive Loss (Unaudited) Three Months Ended June 30, Six Months Ended June 30, (in thousands, except share and per share amounts) 2025 2024 2025 2024 Operating expenses: Research and development $ 29,809 $ 14,645 $ 53,166 $ 26,350 General and administrative 11,094 9,813 19,896 20,312 Total operating expenses 40,903 24,458 73,062 46,662 Loss from operations (40,903 ) (24,458 ) (73,062 ) (46,662 ) Other income/(expense): Interest income 2,774 3,116 5,207 4,772 Interest expense (2,338 ) (466 ) (2,940 ) (900 ) Foreign exchange loss, net (49 ) (32 ) (68 ) (557 ) Change in fair value of 2022 USD Financing Warrants (2,228 ) 13,445 4,771 (19,448 ) Gain on extinguishment of contribution payable — 2,541 — 2,541 Total other income/(expense) (1,841 ) 18,604 6,970 (13,592 ) Net loss (42,744 ) (5,854 ) (66,092 ) (60,254 ) Other comprehensive loss Unrealized gain on investments 36 — 46 — Gain/(loss) on foreign currency translation (31 ) (3 ) (58 ) 490 Comprehensive loss $ (42,739 ) $ (5,857 ) $ (66,104 ) $ (59,764 ) Net loss per common share, basic $ (0.50 ) $ (0.08 ) $ (0.78 ) $ (1.01 ) Net loss per common share, diluted $ (0.50 ) $ (0.26 ) $ (0.81 ) $ (1.01 ) Article content Article content Article content Article content Article content Contacts Article content For Media: Article content Article content Article content
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. 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