SEC 8-K filings with transcript text
Aug 6, 2026
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Exhibit 99.1
Definium Therapeutics Reports Second Quarter 2026 Financial Results and Recent Highlights
Announced positive topline results from Phase 3 Emerge study of DT120 ODT in major depressive disorder (MDD), demonstrating rapid, robust, and durable efficacy
Topline results from Phase 3 GAD studies of DT120 ODT in generalized anxiety disorder (GAD) on track: Voyage results anticipated week of August 10; Panorama results anticipated September 2026
Approximately $1.1 billion in cash, cash equivalents, and investments as of June 30, 2026
Conference call scheduled today at 4:30 p.m. EDT
NEW YORK, August 6, 2026 -- Definium Therapeutics, Inc. (“Definium” or the “Company”) (NASDAQ: DFTX), a late-stage clinical biopharmaceutical company developing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders, today reported financial results for the quarter ended June 30, 2026, and recent highlights.
“The second quarter marked a meaningful inflection point for Definium as we further established our leadership position in psychedelic medicine,” said Rob Barrow, Chief Executive Officer of Definium Therapeutics. “The unprecedented Phase 3 Emerge results validated the highly differentiated profile of DT120 ODT and reinforced its potential to become a best-in-class treatment across multiple psychiatric disorders. We also continued to execute across our pipeline, completing enrollment in Voyage and Panorama and initiating enrollment in Ascend. Our public offering generated approximately $805 million in gross proceeds and provides the capital to advance our clinical and commercial strategy from a position of strength. We believe Definium is uniquely positioned to advance a potential new treatment paradigm across some of the field’s largest and most underserved indications.”
Business Updates
▪ Completed an underwritten public offering of 23,676,471 common shares of the Company for gross proceeds of $805 million. Net proceeds from the offering were approximately $757.9 million, after deducting underwriting discounts and commissions and other offering expenses payable by the Company.
▪ Launched Wired for Worry, a new healthcare provider disease education platform designed to deepen understanding of GAD, reinforce the importance of ongoing assessment, and help healthcare professionals better understand the neurobiological mechanisms that may contribute to the disorder.
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Program Status and Anticipated Milestones
▪ Announced positive topline results from Phase 3 Emerge study (MDD) with 149 participants randomized 1:1 to receive DT120 ODT 100 µg or placebo. Key findings included:
o Met the primary endpoint and all key secondary efficacy endpoints with a high degree of statistical significance.
o Demonstrated a statistically significant and clinically meaningful placebo-adjusted improvement of 8.1 points in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from baseline at Week 6 (Cohen’s d = 0.83; p<0.0001), the study's primary endpoint.
o Demonstrated a statistically significant placebo-adjusted improvement of 7.3 points in MADRS total score from baseline at Week 12 (p<0.0001), the study’s key secondary endpoint.
o DT120 ODT was generally well tolerated, with no serious adverse events and no suicidality signal observed.
▪ Completed enrollment of Phase 3 Voyage study (GAD) with 214 participants randomized 1:1 to receive DT120 ODT 100 µg or placebo. Topline data anticipated the week of August 10, 2026.
▪ Completed enrollment of Phase 3 Panorama study (GAD) with 245 participants randomized 2:1:2 to receive DT120 ODT 100 µg, DT120 ODT 50 µg control, or placebo. Topline data anticipated in September 2026.
▪ Initiated enrollment of Phase 3 Ascend study (MDD). The trial is expected to enroll approximately 165 participants randomized 2:1:2 to receive DT120 ODT 100 µg, DT120 ODT 50 µg control, or placebo. Topline data expected in 2027.
▪ Phase 3 Haven study in posttraumatic stress disorder (PTSD) is expected to initiate in 2027 and enroll approximately 200 participants randomized 1:1 to receive DT120 ODT 100 µg or placebo. The primary endpoint in the study is expected to be the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at Week 8.
Second Quarter 2026 Financial Results
Cash, Cash Equivalents and Investments. As of June 30, 2026, Definium Therapeutics had cash, cash equivalents and investments of approximately $1.1 billion compared to $411.6 million as of December 31, 2025. Based on the Company’s current operating plan and anticipated milestones, the Company believes that its cash, cash equivalents and investments as of June 30, 2026 will be sufficient to fund the Company’s operations into 2030.
Research and Development (R&D). R&D expenses were $48.7 million for the three months ended June 30, 2026 compared to $29.8 million for the three months ended June 30, 2025, an increase of $18.9 milli
May 7, 2026
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Exhibit 99.1
Definium Therapeutics Reports First Quarter 2026 Financial Results and Recent Highlights
Three Phase 3 topline data readouts for DT120 ODT expected in the coming months
DT120 ODT program expanded into PTSD with Phase 3 Haven study expected to initiate in 2027
$373.4 million in cash, cash equivalents, and investments as of March 31, 2026, expected to fund operations into 2028
Conference call scheduled today at 4:30 p.m. EDT
NEW YORK, May 7, 2026 -- Definium Therapeutics, Inc. (“Definium” or the “Company”) (NASDAQ: DFTX), a late-stage clinical biopharmaceutical company developing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders, today reported financial results for the quarter ended March 31, 2026, and recent highlights.
“After an exceptionally productive start to 2026, we are thrilled to enter an exciting and transformative period for Definium, marked by three pivotal data readouts for DT120 ODT anticipated within the next five months and an expanded development program in PTSD,” said Rob Barrow, Chief Executive Officer of Definium Therapeutics. “With enrollment complete in our Emerge and Voyage studies, Panorama enrolling its final participants, and Ascend now underway, our momentum has never been stronger. We are energized by the prospect of reaching multiple critical milestones that will shape our path forward and propel our regulatory strategy for DT120 ODT. Our team remains laser-focused on executing with discipline and scientific rigor to deliver robust, high-quality studies across our pivotal pipeline. We are driven by the urgent need to bring new hope and effective solutions to the millions of individuals battling depression, anxiety, and PTSD.”
First Quarter 2026 and Other Recent Highlights
▪ Completed enrollment in Emerge (MDD) with 149 participants randomized 1:1 to receive DT120 ODT 100 µg or placebo. Topline data expected in late 2Q 2026.
▪ Completed enrollment in Voyage (GAD) with 214 participants randomized 1:1 to receive DT120 ODT 100 µg or placebo. Topline data expected in early 3Q 2026.
▪ Completed the blinded sample size re-estimation for Panorama (GAD) with total target enrollment updated to 200 participants. Current enrollment is over 200 participants, and screening has been closed. Participants are randomized 2:1:2 to receive DT120 ODT 100 µg, DT120 ODT 50 µg control, or placebo. Topline data expected in late 3Q 2026 (updated from 2H 2026).
▪ Continued to activate sites for Ascend, with first patient dosing anticipated in 2Q 2026. The trial is expected to enroll approximately 175 participants randomized 2:1:2 to receive DT120 ODT 100 µg, DT120 ODT 50 µg control, or placebo.
▪ Expanded DT120 ODT clinical development program into PTSD with plans to initiate Haven, a Phase 3 study in PTSD. Haven is expected to enroll approximately 200 participants randomized 1:1 to receive DT120 ODT or placebo. The primary endpoint in the study is the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at Week 8. Study initiation expected in 2027.
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▪ Hosted an Investor and Analyst Day in New York on April 22, 2026. The event featured Definium’s executive leadership team alongside distinguished expert clinicians, who discussed the evolving treatment landscape in psychiatry, significant unmet need, emerging opportunities to improve outcomes for patients, and the Company’s clinical and commercial progress for DT120 ODT.
First Quarter 2026 Financial Results
Cash, Cash Equivalents and Investments. As of March 31, 2026, Definium Therapeutics had cash, cash equivalents and investments of $373.4 million compared to $411.6 million as of December 31, 2025. Based on the Company’s current operating plan and anticipated milestones, the Company believes that its cash, cash equivalents and investments as of March 31, 2026 will be sufficient to fund the Company’s operations into 2028.
Research and Development (R&D). R&D expenses were $41.5 million for the three months ended March 31, 2026 compared to $23.4 million for the three months ended March 31, 2025, an increase of $18.1 million. The increase was primarily due to increases of $15.2 million in DT120 ODT program expenses, $3.2 million in internal personnel costs reflecting expanded research and development capabilities, and $0.3 million in DT402 program expenses, partially offset by a decrease of $0.6 million in preclinical and other program expenses.
General and Administrative (G&A). G&A expenses were $17.7 million for the three months ended March 31, 2026, compared to $8.8 million for the three months ended March 31, 2025, an increase of $8.9 million. The increase was primarily due to increases of $3.9 million in stock-based compensation expense, $1.4 million in personnel-related expenses, $1.4 million in commercial-preparedness related expenses, $1.4 million in corporate and government affairs expenses, and $1.2 million in l
Feb 26, 2026
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Definium Therapeutics Reports Full-Year 2025 Financial Results and Business Updates
Emerge (Phase 3 MDD) enrollment complete; topline data anticipated in late 2Q 2026
Voyage (Phase 3 GAD) approximately 80% enrolled; no change in sample size required; topline readout anticipated in early 3Q 2026
Panorama (Phase 3 GAD) enrollment on track; topline readout expected in 2H 2026
$411.6 million in cash, cash equivalents and investments as of December 31, 2025 expected to fund operations into 2028
Conference call scheduled today at 4:30 p.m. EST
NEW YORK, February 26, 2026 -- Definium Therapeutics, Inc. (“Definium” or the “Company”), a late-stage clinical biopharmaceutical company developing a new generation of therapeutics intended to address underlying causes of psychiatric and neurological disorders, today reported its full-year 2025 financial results and provided business updates.
“We are proud of the strong execution and momentum across our organization, following a year of significant progress in our comprehensive development programs for DT120 ODT,” said Rob Barrow, Chief Executive Officer of Definium Therapeutics. “With our first Phase 3 MDD trial, Emerge, now fully enrolled and advancing toward topline data sooner than anticipated, and our Phase 3 GAD studies, Voyage and Panorama, rapidly progressing toward enrollment completion, 2026 represents a monumental year for Definium. Each of these pivotal readouts represents an important catalyst opportunity to move DT120 ODT one step closer to delivering on its best-in-class potential in both MDD and GAD. We remain committed to precise science and our ambitious view of the potential to deliver meaningful improvements for patients, reinforce our leadership in mental health innovation, and drive long-term shareholder value.”
Business Updates
▪ Completed equity financing in 4Q 2025 totaling approximately $259 million in gross proceeds, before deducting underwriting discounts and commissions and offering expenses payable by the Company, bringing in multiple new institutional investors, and extending the Company’s cash runway into 2028.
▪ Published full study results in the Journal of the American Medical Association from the Company’s randomized, placebo-controlled Phase 2b trial evaluating a single dose of DT120 across four dose levels in patients with moderate to severe generalized anxiety disorder (GAD). DT120 has received FDA Breakthrough Designation for GAD.
▪ Further strengthened the leadership team with the appointments of Brandi L. Roberts as Chief Financial Officer and Matt Wiley as Chief Commercial Officer.
▪ Expanded Board of Directors with appointment of Roger Adsett in January 2026. Mr. Adsett is a highly accomplished biopharmaceutical executive with more than two decades of experience leading landmark drug launches, scaling global commercial organizations, and helping companies establish leadership positions within their therapeutic areas, including specialty, rare disease, and primary care markets. He currently serves as Chief Operating Officer of Insmed.
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▪ Company to host Investor and Analyst Day on April 22, 2026, to discuss program updates and the commercial opportunity for DT120 orally disintegrating tablet (ODT) (lysergide tartrate).
Program Updates and Anticipated Milestones
The program for DT120 ODT (lysergide tartrate) consists of four pivotal Phase 3 studies, two in GAD and two in major depressive disorder (MDD). Each study is comprised of two parts: Part A, a 12-week, randomized, double-blind, placebo-controlled, parallel group assessing the efficacy and safety of DT120 ODT versus placebo, and Part B, a 40-week open-label extension period. The primary endpoint in the GAD studies is the change from baseline in Hamilton Anxiety Scale (HAM-A) score at Week 12 between DT120 ODT 100 µg and placebo; and in the MDD studies the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) score at Week 6 between DT120 ODT 100 µg and placebo.
DT120 ODT (lysergide tartrate) for MDD
▪ Emerge: study is fully enrolled with 149 patients randomized 1:1 to receive DT120 ODT 100 µg or placebo. Topline data are anticipated in late 2Q 2026.
▪ Ascend: initial sites have been activated, and study initiation has been accelerated with first patient dosing anticipated by early 2Q 2026. The trial is expected to enroll approximately 175 participants randomized 2:1:2 to receive DT120 ODT 100 µg, DT120 ODT 50 µg control, or placebo.
DT120 ODT (lysergide tartrate) for GAD
▪ Voyage: study enrollment is approximately 80% complete and is expected to conclude in the coming weeks. Topline data are anticipated in early 3Q 2026. The protocol-specified blinded sample size re-estimation is complete, requiring no increase in enrollment. Voyage is expected to enroll approximately 200 participants in the U.S. randomized 1:1 to receive DT120 ODT 100 µg or placebo.
▪ Panorama: study enrollment on track
Jan 12, 2026
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Exhibit 99.1
MindMed Rebrands to Definium Therapeutics, Advancing a Leading Late-Stage Psychiatry Pipeline with Three Phase 3 Readouts Expected in 2026 Topline Data from Three Phase 3 Studies Evaluating DT120 Orally Disintegrating Tablet (ODT) for GAD and MDD Expected in 2026: Voyage in 2Q, Panorama in 2H, and Emerge Mid-Year Company Presenting at the 44th Annual J.P. Morgan Healthcare Conference on Wednesday, January 14, at 2:15 PM PST Company Shares Will Trade Under New Nasdaq Ticker Symbol "DFTX"
NEW YORK January 12 (BUSINESS WIRE)—Definium Therapeutics, Inc. (formerly Mind Medicine (MindMed) Inc.) (the "Company" or “Definium") unveiled its new brand today, marking a decisive step forward as the company leads psychiatry toward a transformation built on strong clinical evidence, scientific rigor, and the ambition to evolve the treatment paradigm for mental health. Definium is developing innovative, next-generation therapeutics intended to solve the underlying causes of psychiatric and neurological disorders and offer patients long-term remission rather than transient symptom reduction.
Over the past several years, the Company has offered a clear, differentiated vision and executed with discipline, positioning it as a leader in psychiatric drug development. Definium Therapeutics demonstrates this clarity and consistency, representing a confident step forward that best reflects what the Company has become and the enormous potential of what it's building for tomorrow.
"Definium Therapeutics reflects the core of who we've always been and where we're headed - disciplined execution, scientific leadership, and a vision to develop accessible treatments that can unlock healing at scale,” said Rob Barrow, Chief Executive Officer of Definium Therapeutics. “We are unwavering in our mission to forge a new era of psychiatry by applying scientific rigor to psychedelics. By retracing LSD to its origins, we aim to fully realize its clinical potential as a safe and transformative therapeutic. With three Phase 3 readouts expected in 2026, we are uniquely positioned to validate the strength of our science, advance care for patients, and continue delivering long-term value for our shareholders.”
2026 Anticipated Milestones & Events Definium is set to deliver some of the psychiatric field’s most important data in 2026, highlighting its progress and ambition to bring novel, scalable therapies to patients underserved by today’s standard of care. The Company plans to advance DT1201 ODT toward FDA submissions in the two largest psychiatric markets—generalized anxiety disorder (GAD) and major depressive disorder (MDD)—which together affect over 50 million people2 in the U.S.
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Definium’s late-stage pipeline includes four Phase 3 trials—two each for GAD and MDD—anchored by its lead candidate, DT120 ODT, which has received FDA Breakthrough Therapy Designation for GAD. In parallel, the Company is advancing its commercial strategy and operational readiness to support a best-in-class care model and prepare for the potential launch of DT120 ODT, if approved and marketed. Definium also continues to advance its early-stage pipeline, having dosed the first patient in a Phase 2a study of DT4023 in adults with autism spectrum disorder (ASD).
Expected this year:
▪ 2Q 2026: Analyst Day highlighting pivotal programs, pipeline and path to commercialization
▪ 2Q 2026: Topline data from Voyage – the first Phase 3 study of DT120 ODT in GAD
▪ 2H 2026: Topline data from Panorama – the second Phase 3 study of DT120ODT in GAD
▪ Mid-year 2026: Topline data from Emerge – the first Phase 3 study DT120 ODT in MDD
▪ Mid-year 2026: Initiation of Ascend – the second Phase 3 study of DT120 ODT in MDD
▪ 2026: Initial data from DT402 - early signs of efficacy study in ASD
"Definium Therapeutics marks a defining moment in our evolution as we move from shaping what’s possible in psychiatry to setting a new standard for what’s next," said Stephanie Fagan, Chief Corporate Affairs Officer of Definium Theraeutics. “‘Definio’ speaks to our clear sense of direction and scientific precision, and ‘infinitum’ to being open to what hasn’t been done before and the impact we can have on the world. Together, they capture how Definium is moving psychiatry forward for patients and providers—guided by transparency, trust and collaboration with all our stakeholders—measured by the lives we hope to transform.”
In conjunction with the rebrand, the Company’s Nasdaq ticker symbol will change to "DFTX" effective at market open on January 13, 2026.
J.P. Morgan Healthcare Conference Webcast A live audio webcast will be available to investors and other interested parties and can be accessed here.
The audio webcast replay will be available 24 hours after the webcast and active on the investor relations section of Definium’s website for 30 days.
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About Definium Therapeutics The mission of Definium Therapeutics is to forge a new
Nov 6, 2025
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Exhibit 99.1
MindMed Reports Q3 2025 Financial Results and Business Updates
-- Anticipated topline data readouts on track for ongoing Phase 3 studies of MM120 Orally Disintegrating Tablet (ODT) in GAD: Voyage (1H 2026) and Panorama (2H 2026)--
--Anticipated topline data readout from first Phase 3 study of MM120 ODT in MDD (Emerge) accelerated to mid-2026, aligning with the anticipated initiation of second Phase 3 study in MDD (Ascend)--
--MM120 Phase 2b GAD Study published in the Journal of the American Medical Association (JAMA)--
--Continued advancement of pipeline with planned Phase 2a study initiation of MM402 in Autism Spectrum Disorder (ASD) in 4Q 2025--
--Cash, cash equivalents and marketable securities totaled $209.1 million as of September 30, 2025; completed underwritten public offering of common stock with net proceeds of $242.8 million on October 31, 2025--
--Conference call scheduled today at 4:30 p.m. EST--
NEW YORK, November 6, 2025 – 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 reported financial results for the third quarter ended September 30, 2025 and provided business updates.
“2025 continues to be a year of strong execution, and our recent $258.9 million financing further strengthens our position as we prepare for a transformational 2026,” said Rob Barrow, Chief Executive Officer of MindMed. “Enrollment across all three pivotal MM120 ODT trials remains on track. Given faster than expected enrollment in Emerge, our first Phase 3 study in MDD, we have accelerated guidance for topline data readout which is now expected in mid-2026. We plan to initiate Ascend, our second Phase 3 study in MDD, in mid-2026 and remain focused on advancing toward FDA submissions in both generalized anxiety disorder (GAD) and major depressive disorder (MDD). We are also excited to advance our pipeline with the start of a Phase 2a study of MM402 in ASD. With multiple anticipated Phase 3 topline data readouts ahead, 2026 is set to be the most significant year in our history to date, as our team works to bring new treatment options to both providers and patients.”
Business Updates
• On October 31, 2025, the Company completed an underwritten public offering of 21,131,250 common shares of the Company for gross proceeds of $258.9 million. Net proceeds from the offering were approximately $242.8 million, after deducting underwriting discounts and commissions and other estimated offering expenses payable by the Company.
• The Company published full study results in JAMA from its randomized, placebo-controlled Phase 2b trial evaluating a single dose of MM120 across four dose levels in patients with moderate to severe GAD. The Phase 2b study demonstrated a statistically significant dose-response relationship at the primary endpoint following a single administration of MM120 across four dose levels, with improvements sustained throughout the 12-week observation period. MM120 100 µg was determined to be the optimal dose, meeting its primary and key secondary endpoints, demonstrating a clinically and statistically significant improvement vs. placebo, and a 65% clinical response rate and 48% clinical remission rate at Week 12. MM120 was well-tolerated with mostly mild-to-moderate adverse events that were limited to the dosing day and consistent with the mechanism of action of lysergide D-tartrate (LSD). These results represent a substantial improvement over currently approved
therapies for GAD, which led to MM120 being granted Breakthrough Therapy Designation (BTD) from FDA in March 2024.
Program Status and Anticipated Milestones
MM120 ODT (lysergide D-tartrate) for GAD
• 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 control, 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.
MM120 (lysergide D-tartrate) for MDD
• Enrollment in the Phase 3 Emerge study of MM120 ODT for the treatment of MDD has progressed faster than previously expected and topline data from the 12-week double-blinded period (Part A) is now anticipated in mid-2026 (previously 2H 2026). Emerge is expected to enroll approximately 140 participants (randomized 1:1 to receive MM120 ODT 100 µg or placebo).
• The Company plans to initiate Ascend
Oct 29, 2025
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Exhibit 99.1
Corporate Presentation October 2025
2 This presentation (the “Presentation”) has been prepared by Mind Medicine (MindMed) Inc. (“MindMed”, the “Company”, “we”, “ou r” or “us") solely for informational purposes. This Presentation does not constitute an offering of, or a solicitation of an offer to purchase, securities of MindMed and under no circumstances is it to be construe d a s a prospectus or advertisement or public offering of securities. Any trademarks included herein are the property of the owners thereof and are used for reference purposes only. Such use should not be construed as a n e ndorsement of the products or services of MindMed. Any amounts are in USD unless otherwise noted. MindMed’s securities have not been approved or disapproved by the U.S. Securities and Exchange Commission (the "SEC") or by any state, pr ovincial or other securities regulatory authority, nor has the SEC or any state, provincial or other securities regulatory authority passed on the accuracy or adequacy of this Presenta tio n. Any representation to the contrary is a criminal offense . Cautionary Note Regarding Forward - Looking Statements This Presentation contains, and our officers and representatives may from time to time make, “forward - looking statements” within the meaning of applicable securities laws and are prospective in nature. Forward - looking statements are 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”, “continue”, “budget”, “scheduled”, “fo rec asts”, “intends”, “anticipates”, “projects” or the negative thereof or similar variations. Forward - looking statements in this Presentation include, but are not limited to, statements regarding the anticipated design, timing, pr ogress and results of our investigational programs for MM120 oral disintegrating tablet (“ODT”), a proprietary, pharmaceutically optimized form of lysergide D - tartrate (including the anticipated topline readouts for the Voyage, Panorama, Emerge and Ascend studies), MM402, also referr ed to as R( - ) - MDMA, and any other product candidates; our ability to identify new indications for our lead product candidates beyond our cu rre nt primary focuses; the success and timing of our development activities; the success and timing of our planned clinical trials; our ability to meet the milestones set forth herein; the likelihood of success of any clinical trials or of obtaining U.S. Food and Drug Administration (“FDA”) or other regulatory approvals; our beliefs regarding potential benefits of our product candidates; opinions of potential providers regarding our pro duct candidates, if approved and commercialized; our ability to maximize operational efficiencies through our trial designs; strategies to address drug class methodological considerations; our cash runway fundi ng operations into 2027 based on our current operating plan and anticipated research and development milestones; our pre - launch strategy; the potential commercial opportunity for MM120 ODT, if approved, including tota l addressable market; the potential delivery model for MM120 ODT, if approved; the potential for the markets that we are anticipating to access and protection of our intellectual property . There are numerous risks and uncertainties that could cause actual results, plans and objectives to differ materially from th ose expressed in forward - looking statements, including history of negative cash flows, limited operating history, incurrence of future losses, availability of additional capital, compliance with laws and regulati ons , difficulty associated with research and development, risks associated with clinical trials or studies, heightened regulatory scrutiny, early stage product development, clinical trial risks, regulatory approval processes , n ovelty of the psychedelic inspired medicines industry, our ability to maintain effective patent rights and other intellectual property protection for our product candidates, our expectations regarding the size of t he eligible patient populations for our lead product candidates, if approved and commercialized; our ability to identify third - party treatment sites to conduct our trials and our ability to identify and train appropriate qualified healthcare practitioners to administer our treatments; the pricing, coverage and reimbursement of our lead product candidates, if approved and commercialized; the rate and degree of market acce pta nce and clinical utility of our lead product candid
Jul 31, 2025
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Exhibit 99.1
MindMed Reports Q2 2025 Financial Results and Business Updates
--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)--
--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--
--Strengthened leadership team with appointment of Brandi L. Roberts as Chief Financial Officer--
--Conference call scheduled today at 4:30 p.m. EDT--
NEW YORK, July 31, 2025 – 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.”
Business Highlights
• 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.
Program Status and Anticipated Milestones
MM120 ODT (lysergide D-tartrate) for GAD
• 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.
MM120 (lysergide D-tartrate) for MDD
• 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.
MM402 (R(-)-MDMA) for Autism Spectrum Disorder (ASD)
• 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.
Second Quarter 2025 Financial Results
Cash Balance. 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.
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.
Research and Development (R&D). 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
May 8, 2025
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Exhibit 99.1
MindMed Reports First Quarter 2025 Financial Results and
Recent Business Updates
--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--
--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--
--Company to host a conference call today at 8:00 a.m. EDT--
NEW YORK, May 8, 2025 – 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.”
Business Highlights
• 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.
Program Updates and Anticipated Milestones
MM120 ODT (lysergide D-tartrate) for GAD
• 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.
MM120 ODT (lysergide D-tartrate) for MDD
• 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.
MM402 (R(-)-MDMA) for Autism Spectrum Disorder (ASD)
• 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.
First Quarter 2025 Financial Results
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 opera
Mar 6, 2025
2 mnmd-ex99_1.htm
Exhibit 99.1
MindMed Reports Fourth Quarter and Full-Year 2024 Financial Results and Recent Business Updates
--First Patients Dosed in Phase 3 Voyage and Panorama studies of MM120 Orally Disintegrating Tablet (ODT) in Generalized Anxiety Disorder (GAD); 12-week topline data anticipated in 1H 2026 for Voyage and 2H 2026 for Panorama--
--On track to initiate Emerge, the first Phase 3 study of MM120 ODT in Major Depressive Disorder (MDD) in 1H of 2025--
--Raised approximately $250 million in gross proceeds through two equity financings in 2024; cash and cash equivalents of $273.7 million as of December 31, 2024, expected to fund operations into 2027 and extend at least 12 months beyond the first Phase 3 topline data readout for MM120 ODT in GAD--
--Company to host a conference call today at 8:00 a.m. EST--
NEW YORK, March 6, 2025 – 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 fourth quarter and full year 2024 financial results and provided an update on business highlights.
“2024 was a year of significant progress for MindMed. We successfully achieved several key milestones that have built momentum for multiple clinical readouts from our MM120 ODT Phase 3 development program, which are expected to drive our next phase of growth,” said Rob Barrow, Chief Executive Officer of MindMed. “The positive data from our MM120 Phase 2b study in GAD helped secure breakthrough therapy designation from the FDA and led to the expansion of our pipeline into MDD. In 2025, we are focused on enrolling our Phase 3 GAD and MDD studies, as well as regulatory and pre-commercialization activities to support the development of MM120 ODT. We are well positioned to deliver transformational innovation that has the potential to redefine treatment for the over 50 million people living with anxiety and depression.”
Business Highlights
• Completed equity financings in 2024 totaling approximately $250 million in gross proceeds, bringing in several new institutional investors, and extending the Company’s cash runway into 2027. This is expected to fund the Company at least 12 months beyond the first Phase 3 topline data readout for MM120 ODT in GAD.
• MM120 ODT patent issued covering pharmaceutical formulation, and methods of manufacturing and treatment; extends patent life through 2041.
• Strengthened leadership team with the appointments of Stephanie Fagan as Chief Corporate Affairs Officer and Gregg A. Pratt, Ph.D., as Chief Regulatory and Quality Assurance Officer.
• The Company was added to the Nasdaq Biotechnology Index (NBI) in November 2024 and the Russell 2000® and Russell 3000® Indexes in June 2024.
Program Updates and Anticipated Milestones
MM120 ODT (lysergide D-tartrate) for GAD
• Initiated dosing in the Phase 3 Voyage study of MM120 ODT for the treatment of GAD in the fourth quarter of 2024. 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.
• Initiated dosing in Panorama, the second Phase 3 study of MM120 ODT in GAD, in the first quarter 2025. 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.
• Presented the full data set from the Phase 2b study of MM120 in GAD at the 2024 American Psychiatric Association (APA) Annual Meeting (here) and presented encore data from the study at the American College of Neuropsychopharmacology (ACNP) 2024 Congress (here).
• FDA granted breakthrough designation to the MM120 program for the treatment of GAD.
• U.K. Innovative Licensing and Access Pathway (ILAP) steering group under the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) granted an Innovation Passport for MM120 ODT for the potential treatment of GAD. The Innovation Passport is the entry point to the ILAP, which aims to accelerate time to market and facilitate patient access to medicines in the U.K.
MM120 (lysergide D-tartrate) for MDD
• On track to initiate Emerge, the first Phase 3 study of MM120 ODT for the treatment of MDD in the first half of 2025. 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.
MM402 (R(-)-MDMA) for Autism Spectrum Disorder (ASD)
• 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
Nov 7, 2024
2 mnmd-ex99_1.htm
Exhibit 99.1
MindMed Reports Third Quarter 2024 Financial Results and Business Updates
--On track to initiate the Phase 3 Voyage study of MM120 Orally Disintegrating Tablet (ODT) in Generalized Anxiety Disorder (GAD) in the fourth quarter of 2024; 12-week topline data anticipated in the first half of 2026--
--On track to initiate the Phase 3 Panorama study of MM120 ODT in GAD and the Phase 3 Emerge study of MM120 ODT in Major Depressive Disorder (MDD) in the first half of 2025--
--Cash and cash equivalents of $295.3 million as of September 30, 2024, expected to fund operations into 2027 and extend at least 12 months beyond the first Phase 3 topline data readout for MM120 ODT in GAD--
--Company to host a conference call today at 4:30 p.m. EST--
NEW YORK, November 7, 2024 – Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (the "Company" or "MindMed"), a clinical-stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced its financial results for the quarter ended September 30, 2024, and provided a business update.
“This is a pivotal moment for MindMed as we prepare to initiate Voyage, our first Phase 3 study of MM120 ODT in GAD,” said Rob Barrow, Chief Executive Officer of MindMed. “Beyond Voyage, we are on track to initiate two additional Phase 3 studies: the Panorama study, our second trial in GAD, and the Emerge study, our first trial of MM120 ODT in MDD. Our Phase 3 development strategy leverages high-performing clinical trial sites from our Phase 2 study, as well as thoughtfully aligned protocols, which we expect to enable efficient enrollment across GAD and MDD. Our strong execution throughout the year has positioned us as a well-financed, late-stage clinical leader, set to launch three Phase 3 studies targeting two indications affecting approximately 51 million adults in the U.S. I could not be more pleased with our progress as we continue to build a high-performing organization dedicated to transforming the standard of care for people with brain health disorders.”
Program Updates and Anticipated Milestones
MM120 (lysergide D-tartrate) for GAD
▪ The Company is on track to initiate the Phase 3 Voyage study of MM120 ODT, a pharmaceutically optimized form of lysergide D-tartrate (LSD) for the treatment of adults with GAD in the fourth quarter of 2024. The Company expects the topline readout from the 12-week double-blind period (Part A) of Voyage in the first half of 2026.
▪ The Phase 3 clinical program for MM120 ODT in GAD consists of two clinical studies: the Voyage study (MM120-300) and the Panorama study (MM120-301).
o Both studies are comprised of two parts: Part A, which is a 12-week, randomized, double-blind, placebo-controlled, parallel group study assessing the efficacy and safety of MM120 ODT versus placebo; and Part B, which is a 40-week extension period during which participants will be eligible for open-label treatment with MM120 ODT, subject to certain conditions for treatment eligibility.
o Voyage is anticipated to enroll approximately 200 participants in the U.S. who will be randomized 1:1 to receive MM120 ODT 100 µg or placebo, and Panorama is anticipated to enroll approximately 240 participants (randomized 5:2:5 to receive MM120 ODT 100 µg, MM120 ODT 50 µg or placebo).
o The primary endpoint for each study is the change from baseline in Hamilton Anxiety Rating Scale (HAM-A) score at Week 12 between MM120 ODT 100 µg and placebo.
o Both studies are expected to employ an adaptive design with interim blinded sample size re-estimation based on nuisance parameters (e.g. participant retention rate, variability of primary outcome measure) which allows for an increase of sample size up to 50% to maintain statistical power.
▪ Panorama, the second Phase 3 study, will be conducted in the U.S. and Europe and is on track to initiate in the first half of 2025 with an anticipated topline readout from the 12-week double-blind period (Part A) in the second half of 2026.
MM120 (lysergide D-tartrate) for MDD
▪ The Company is also developing MM120 ODT for the treatment of adults with MDD, beginning with the Emerge study (MM120-310) which, like the Phase 3 studies in GAD, is comprised of two parts: Part A, which is a 12-week, randomized, double-blind, placebo-controlled, parallel-group study assessing the efficacy and safety of MM120 ODT versus placebo; and Part B, which is a 40-week extension period during which participants will be eligible for open-label treatment with MM120 ODT, subject to certain conditions for treatment eligibility.
o Emerge is anticipated to enroll at least 140 participants (randomized 1:1 to receive MM120 ODT 100 µg or placebo).
o The primary endpoint is the change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) score at Week 6 between MM120 ODT 100 µg and placebo.
o The Company expects to initiate Emerge in the first half of 2025 with an anticipated
Aug 13, 2024
2 mnmd-ex99_1.htm
Exhibit 99.1
MindMed Reports Second Quarter 2024 Financial Results and Business Updates
--Completed End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA); on track to initiate Phase 3 clinical program for MM120 orally disintegrating tablet (ODT) in Generalized Anxiety Disorder (GAD) in the second half of 2024--
--Expanding pipeline with MM120 ODT clinical program in Major Depressive Disorder (MDD) with plans to initiate a registrational study in first half of 2025--
--New patent issued by the United States Patent and Trademark Office (USPTO) extends intellectual property protection for MM120 ODT through 2041--
--Company to host a conference call today at 8:00 a.m. EDT--
NEW YORK, August 13, 2024 – Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (the "Company" or "MindMed"), a clinical-stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced its financial results for the quarter ended June 30, 2024, and provided a business update.
“Building on the positive momentum from our Phase 2b data for MM120 ODT in GAD, we are excited to be launching our Phase 3 clinical program in GAD later this year and to announce the expansion of our pipeline as we embark on a registrational study for MM120 ODT in MDD,” said Rob Barrow, Chief Executive Officer of MindMed. “In June, we successfully completed our End-of-Phase 2 meeting with the FDA, aligning on Phase 3 requirements for MM120 ODT in GAD, with initiation of our first Phase 3 trial on track for the second half of the year. We have also extended our intellectual property protection for MM120 ODT through 2041 bolstering our market protection strategy. With a cash balance of $243.1 million as of June 30, 2024, and our recently closed $75 million in gross proceeds, we are well-positioned to rapidly advance our R&D pipeline with exemplary operational and financial efficiency to numerous readouts beginning in the first half of 2026. The $250 million of equity investment into MindMed since the beginning of 2024 extends our cash runway into 2027, which we believe will be at least 12 months beyond our first Phase 3 clinical readout for MM120 ODT in GAD.”
Business Update
▪ Completed an underwriting offering of its common shares and pre-funded warrants to purchase common shares for $75.0 million in gross proceeds before deducting transaction fees and other offering related expenses.
▪ In July 2024, the Company announced issuance of a new patent (USPN 12,036,220) by the USPTO covering claims related to the pharmaceutical formulation, methods of manufacturing and method of treatment for MM120 ODT. This patent extends the Company’s intellectual property protection for MM120 through 2041.
▪ The Company voluntarily delisted its common shares from Cboe Canada. The Company’s common shares continue to be listed and tradable on Nasdaq under the symbol “MNMD”.
Program Updates and Anticipated Milestones
MM120 (lysergide D-tartrate) for GAD
▪ In June 2024, the Company announced the completion of its EOP2 meeting with the FDA, supporting the advancement of MM120 into pivotal trials for the treatment of adults with GAD.
▪ The Phase 3 clinical program for MM120 ODT consists of two clinical trials: the Voyage Study (MM120-300) and the Panorama Study (MM120-301).
o Both trials are comprised of two parts: Part A, which is a 12-week, randomized, double-blind, placebo-controlled, parallel group study assessing the efficacy and safety of MM120 ODT versus placebo; and Part B, which is a 40-week extension study during which participants will be eligible for open-label treatment with MM120, subject to certain conditions for re-treatment eligibility.
o Voyage is anticipated to enroll approximately 200 participants (randomized 1:1 to receive MM120 ODT 100 µg or placebo) and Panorama is anticipated to enroll approximately 240 participants (randomized 5:2:5 to receive MM120 ODT 100 µg, MM120 ODT 50 µg or placebo).
o The primary endpoint for each trial is the change from baseline in Hamilton Anxiety Rating Scale (HAM-A) score at Week 12 between MM120 ODT 100 µg and placebo.
o Both trials will employ an adaptive design with interim blinded sample size re-estimation based on nuisance parameters (e.g. patient retention rate, variability of primary outcome measure) which allows for an increase of sample size up to 50% to maintain statistical power.
o The Company expects to initiate Voyage in the second half of 2024 with an anticipated topline readout (Part A results) in the first half of 2026. Panorama is expected to start in the first half of 2025 with an anticipated topline readout (Part A results) in the second half of 2026.
MM120 (lysergide D-tartrate) for MDD
▪ The Company is also developing MM120 ODT for the treatment of Major Depressive Disorder (MDD), beginning with the Emerge Study (MM120-310), which like the pivotal studies in GAD, is comprised of two parts:
Aug 12, 2024
6 tm2420790d4_ex99-1.htm
Exhibit 99.1
Mind Medicine (MindMed) Inc. Announces Proposed Public Offering
NEW YORK, August 9, 2024 – Mind Medicine (MindMed) Inc. (NASDAQ: MNMD) (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced that it intends to offer and sell, subject to market conditions, common shares and, to certain investors, pre-funded warrants to purchase common shares in an underwritten public offering. All of the common shares and pre-funded warrants are being offered by MindMed.
MindMed intends to use the net proceeds from this offering to fund the research and development of its product candidates and working capital and general corporate purposes.
Leerink Partners and Evercore ISI are acting as the joint bookrunning managers for the offering. RBC Capital Markets and Oppenheimer & Co. are acting as lead managers. The offering is subject to market conditions and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. No distribution under the offering shall occur in Canada or to a person resident in Canada.
The securities in the offering are being offered by the Company pursuant to an effective shelf registration statement on Form S-3 (File No. 333-280548) that was filed with the Securities and Exchange Commission (“SEC”) on June 28, 2024 and became effective upon filing. The securities will be offered by means of a prospectus supplement and accompanying prospectus relating to the offering that form a part of the shelf registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to and describing the terms of the offering will be filed with the SEC and SEDAR+ and will be available on the SEC’s website at www.sec.gov and on SEDAR+’s website at www.sedarplus.ca. Copies of the preliminary prospectus supplement, when available, and the accompanying prospectus relating to the offering may be obtained, when available, by contacting the following: Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at syndicate@leerink.com, or Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at ecm.prospectus@evercore.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About MindMed
MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders.
MindMed trades on NASDAQ under the symbol MNMD.
Certain statements in this press 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 press release includes, but is not limited to, the uncertainties related to market conditions, the intended use of proceeds, the filing of the preliminary prospectus supplement and the accompanying prospectus relating to the offering and the completion of the offering on the anticipated terms or at all. There can be no assurance that this offering will close and the Company will receive the net proceeds therefrom. 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 market conditions and satisfaction of the customary closing conditions for the offering. These forward-looking statements are based on our current expec
May 8, 2024
2 mnmd-ex99_1.htm
Exhibit 99.1
MindMed Reports First Quarter 2024 Financial Results and Business Updates
--Announced positive Phase 2b clinical trial results for MM120 in Generalized Anxiety Disorder (GAD), demonstrating clinically and statistically significant activity through 12 weeks after treatment--
--The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to MM120 for the treatment of GAD in adults--
--Cash and cash equivalents of $252.3 million as of March 31, 2024--
--Company to host a conference call today at 4:30 p.m. EDT--
NEW YORK, May 8, 2024 – Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (the "Company" or "MindMed"), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced its financial results for the quarter ended March 31, 2024, and provided a business update.
“Building on a highly productive 2023, we were pleased to start the year by announcing that our Phase 2b trial of MM120 in GAD hit its key secondary endpoint with clinically and statistically significant activity observed through Week 12 of the study,” said Rob Barrow, Chief Executive Officer of MindMed. “Additionally, the results we shared from our Phase 1 pharmacokinetics bridging trial support the advancement of our MM120 oral dissolving tablet (ODT) formulation into pivotal clinical trials, with our Phase 3 program of MM120 in GAD on track to initiate in the second half of 2024. We also presented at several recent medical meetings highlighting the continued unmet need, burden and increasing prevalence of GAD. With a strong balance sheet expected to fund operations through numerous key milestones, we look forward to providing additional updates on our GAD program, as well as on our pipeline as we advance MM402 for the treatment of autism spectrum disorder (ASD), and potentially expand into additional indications for MM120.”
Business Update
▪ The Company completed an underwritten offering and concurrent private placement for $175.0 million in gross proceeds before deducting transaction fees and other offering related expenses.
▪ The Company voluntarily delisted its common shares from Cboe Canada. The Company’s common shares continue to be listed and tradable on Nasdaq under the symbol “MNMD”.
Program Updates and Anticipated Milestones
MM120 (lysergide D-tartrate) for GAD
▪ In March 2024, the Company announced that FDA granted Breakthrough Therapy Designation (BTD) to MM120 for the treatment of GAD in adults.
▪ In March 2024, the Company announced that its Phase 2b study of MM120 in GAD met its key secondary endpoint with data demonstrating rapid, robust, and durable activity, which was clinically and statistically significant through Week 12.
o MM120 100 µg – the dose with optimal clinical activity observed in the trial – demonstrated a 7.7-point improvement over placebo at Week 12 (-21.9 MM120 vs. -14.2 placebo; p<0.003 Cohen’s d=0.81), with a 65% clinical response rate and a 48% clinical remission rate sustained to Week 12.
o Clinical Global Impressions - Severity (CGI-S) scores, on average, improved from 4.8 to 2.2 in the 100-µg dose group, representing a two-category shift from ‘markedly ill’ to ‘borderline ill’ at Week 12 (p<0.004). This clinical activity was rapid, observed as early as study day 2, and durable, with further improvements observed in mean HAM-A or CGI-S scores between Weeks 4 and 12.
o MM120 was generally well-tolerated in the trial, with most adverse events rated as mild to moderate, transient, occurring on dosing day, and consistent with expected acute effects of the study drug.
▪ In March 2024, the Company announced results from its pharmacokinetics (PK) bridging study to support the advancement of the MM120 Zydis® oral dissolving tablet (ODT) formulation into pivotal clinical trials.
o In the trial, the Zydis® ODT formulation demonstrated 50% faster onset of action and meaningful improvements in both the overall area under the curve and the area under the curve above target or therapeutic concentrations compared to the non ODT formulation.
o We believe the Zydis® ODT formulation offers numerous product performance, clinical, and intellectual property benefits.
▪ The Company presented detailed results from its Phase 2b study of MM120 in GAD, as well as multiple presentations describing the epidemiology and growing burden of GAD at the following conferences:
o European Psychiatric Association (EPA) 2024 Congress
o Anxiety & Depression Association of America (ADAA) 2024 Conference
o American Psychiatric Association (APA) 2024 Congress
o International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2024
▪ One-year follow-up data from a Phase 2 placebo-controlled investigator-initiated clinical trial of lysergide in the treatment of anxiety disorders will be presented at the Society of Biological Psychiatry (SOBP) 2024 Annual Meeting being held May 9-
Feb 28, 2024
2 mnmd-ex99_1.htm
Exhibit 99.1
MindMed Reports 2023 Financial Results and Business Updates
--Announced statistically significant and clinically meaningful topline Phase 2b data for MM120 at 4 weeks in Generalized Anxiety Disorder (GAD)--
--Multiple planned milestones for MM120 in GAD, including 12-week Phase 2b data to be presented at March 7th investor event, and initiation of Phase 3 clinical program in second half of 2024--
--Initiated Phase 1 clinical trial of MM402 in Autism Spectrum Disorder (ASD)--
--Conference call to discuss year-end financial results at 8:00 a.m. EST--
NEW YORK, February 28, 2024 – Mind Medicine(MindMed) Inc. (NASDAQ:MNMD), (Cboe Canada:MMED), (the "Company" or "MindMed"), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today announced its financial results for the year ended December 31, 2023 and provided a business update.
“2023 was a highly productive year for MindMed, which concluded with positive Phase 2b results for MM120 in the treatment of adult patients with GAD," said Rob Barrow, Chief Executive Officer and Director of the Company. “We believe the initial data we shared validates our scientific understanding of MM120’s mechanism of action and shows the potential to have a best-in-class product profile compared to today’s standard of care. We look forward to sharing 12-week safety, efficacy, and durability data and results from our Phase 1 pharmacokinetics bridging trial to support the advancement of our MM120 oral dissolving tablet (ODT) formulation into pivotal clinical trials at our virtual investor event in March. Looking further into 2024, we anticipate several additional milestones, including one-year follow-up results from an investigator-initiated clinical trial of lysergide in anxiety disorders conducted by our collaborators at University Hospital Basel. We will be working closely with the FDA to finalize our Phase 3 development program for MM120 in GAD and expect to hold our End-of-Phase 2 meeting with the FDA in the first half of the year. This is intended to enable the initiation of our Phase 3 clinical program in the second half of the year.”
Business Update
▪ The Company will host a virtual investor event on March 7, 2024 to provide 12-week data from the Phase 2 program for MM120 being developed for the treatment of GAD. Senior management and key opinion leaders will discuss the treatment landscape, market potential and commercial opportunity for MM120 in GAD and other psychiatric disorders.
Program Updates and Anticipated Milestones
MM120 (lysergide D-tartrate) for GAD
▪ In December 2023, the Company announced statistically significant and clinically meaningful topline 4- week data from the 198-patient Phase 2b dose-optimization trial of MM120 for the treatment of GAD.
o MM120 100 µg – the dose achieving the highest level of clinical activity – demonstrated a 7.6- point reduction on the Hamilton Anxiety rating scale (HAM-A)compared to placebo at Week 4
(-21.3 MM120 vs. -13.7 placebo; p<0.0004; Cohen’s d effect size=0.88), which is more than double the effect sizes seen with the current standards of care1.
o Clinical response (50% or greater improvement in HAM-A) at Week 4 was achieved in 78% of participants treated with MM120 (100 µg or 200 µg) compared to 31% for placebo.
o Clinical remission (HAM-A≤ 7) at Week 4 was achieved in 50% of participants treated with MM120 100 µg compared to 18% for placebo.
▪ The Company plans to share topline 12-week safety, efficacy, and durability results from the Phase 2b study and results from its pharmacokinetics bridging trial of the MM120 Zydis® ODT formulation, its intended commercial formulation of MM120, at an upcoming virtual investor event on March 7, 2024.
▪ The Company anticipates that full results from the Phase 2b trial of MM120 in GAD will be presented at a scientific meeting in 2024.
▪ The Company plans to hold an End-of-Phase 2 meeting with the FDA in the first half of 2024 and expects to initiate its Phase 3 clinical program in the second half of 2024.
▪ One-year follow-up data from a Phase 2 placebo-controlled investigator-initiated clinical trial of lysergide in the treatment of anxiety disorders is anticipated in 2024. This trial was conducted by the Company’s collaborators at University Hospital Basel (UHB) in Switzerland and completed in Q3 2023.
MM402 (R(-)-MDMA) for ASD
▪ The Company initiated its first clinical trial of MM402 (R(-)-MDMA), a single-ascending dose trial in adult healthy volunteers in Q4 2023. This Phase 1 trial is intended to characterize the tolerability, pharmacokinetics and pharmacodynamics of MM402 and should enable further clinical trials to characterize the effects of repeated daily doses of MM402 and the exploration of early signs of efficacy in the ASD population.
▪ In October 2023, the Company presented results from a nonclinical study in a model of ASD, titled “M
Nov 2, 2023
2 mnmd-ex99_1.htm
Exhibit 99.1
MindMed Reports Third Quarter 2023 Financial Results and Business Highlights
– Topline readout of MM-120 in GAD (Phase 2b) expected in Q4 2023 –
– Topline readout of MM-120 in ADHD (Phase 2a proof-of-concept) anticipated by the end of Q1 2024 –
– MM-402 in ASD on track for Phase 1 clinical trial initiation in Q4 2023 –
– Cash and cash equivalents of $117.7 million at September 30, 2023 –
– Company to host conference call today at 4:30 PM ET –
NEW YORK, November 2, 2023 -- Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today reported its financial results for the quarter ended September 30, 2023.
“During the third quarter we continued to focus on execution ahead of several key data readouts in the coming months. This includes, in particular, topline results from our Phase 2b study of MM-120 in generalized anxiety disorder (GAD) which are anticipated by the end of this year. Additionally, we anticipate the initiation of our Phase 1 study of MM-402 by the end of this year and reporting topline data from our proof-of-concept study of MM-120 in ADHD by the end of Q1 2024.” said Robert Barrow, Chief Executive Officer and Director of MindMed. “The continued growth in prevalence and impact of GAD, ASD and other brain health disorders highlights the importance and timeliness of our innovative programs. Our team remains singularly focused on delivering novel treatments for brain health disorders to the millions of patients in need and we are eager to share these important milestones in the months ahead.”
Recent Highlights and Anticipated Upcoming Milestones:
Phase 2b study evaluating MM-120 for generalized anxiety disorder (GAD) in adults.
• Study MMED008 is a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. The trial enrolled 198 participants who were randomized to receive a single oral administration of MM-120 (25 µg, 50 µg, 100 µg or 200 µg) or placebo.
• The primary objective of the study is to determine the dose-response relationship of four doses of MM-120 versus placebo as measured by the change in Hamilton Anxiety Rating Scale (HAM-A) from Baseline to Week 4.
• Dosing is complete with topline results for the primary endpoint (Week 4) expected to be announced in Q4 2023.
• We anticipate the announcement of 12-week safety and efficacy results by the end of Q1 2024 and the presentation of the full data from the study at a scientific meeting in 2024.
Proof-of-Concept study evaluating repeated low-dose administration of MM-120 for attention-deficit/hyperactivity disorder (ADHD) in adults.
• Study MMED007 is a multi-center, randomized, double-blind, placebo-controlled study. The trial enrolled 53 participants who were randomized to receive twice-weekly oral doses of MM-120 20 μg or placebo for 6 weeks.
• Topline results expected by the end of Q1 2024.
• The primary endpoint of this study is the mean change from baseline at Week 6 in ADHD symptoms, as assessed by the Adult ADHD Investigator Rating Scale (AISRS).
Advancing development of MM-402 (R(-)-MDMA) for autism spectrum disorder (ASD) into first clinical trial in Q4 2023.
• The Company plans to initiate its first clinical trial of MM-402 in Q4 2023. This Phase 1 study is intended to characterize the tolerability, pharmacokinetics and pharmacodynamics of MM-402, and to evaluate early signals of efficacy to support the Company’s approach in targeting core symptoms of ASD in adults.
• University Hospital Basel (UHB) in Switzerland, the Company’s collaborator, is currently enrolling participants in a Phase 1 investigator-initiated trial of R(-)-MDMA, S(+)-MDMA and R/S-MDMA in healthy adult volunteers. This trial is designed to assess the tolerability, pharmacokinetics and acute subjective, physiological and endocrine effects of the three molecules. The Company anticipates topline results to be presented in the first half of 2024.
• In October 2023, the Company presented results from a MM-402 nonclinical study in a model of ASD, titled “MM-402 demonstrates better efficacy than S(+)-3,4-MDMA or (±)-3,4-MDMA in Fmr1 knockout mice, an animal model of autism spectrum disorder” at the 36th Annual European College of Neuropsychopharmacology (ECNP) Congress.
Third Quarter 2023 Financial Results
Cash and Cash Equivalents Balance. As of September 30, 2023, MindMed had cash and cash equivalents totaling $117.7 million compared to $142.1 million as of December 31, 2022. The Company believes its available cash and cash equivalents as well as its committed credit facility are expected to fund operations into 2026, if certain milestones are achieved that unlock additional capital.
Net Cash Used in Operating Activities. For the nine months ended September 30, 2023, net cash used in operating activities
Aug 3, 2023
2 mnmd-ex99_1.htm
Exhibit 99.1
MindMed Reports Second Quarter 2023 Financial Results and Business Highlights
– Topline readout of MM-120 in GAD (Phase 2b) expected in Q4 2023 with enrollment to be concluded in Q3 2023 –
– Topline readout of MM-120 in ADHD (Phase 2a proof-of-concept) anticipated in Q4 2023 / Q1 2024 –
– MM-402 in ASD on track for Phase 1 clinical trial initiation in Q4 2023 –
– Entered into exclusive license agreement with Catalent for MM-120 Zydis® orally disintegrating tablet (ODT) formulation for advancement into pivotal clinical trials –
– Cash and cash equivalents of $116.9 million at June 30, 2023 –
– Company to host conference call today at 4:30 PM ET –
NEW YORK, August 3, 2023 -- Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the “Company” or "MindMed"), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today reported its financial results for the quarter ended June 30, 2023.
“We’re coming up on a critical period for MindMed as we are close to wrapping up enrollment in our Phase 2b study of MM-120 for the treatment of generalized anxiety disorder” said Robert Barrow, Chief Executive Officer and Director of MindMed. “Our ability to enroll a study of this size in such an efficient manner stands out in the field and speaks to the remarkable quality of our R&D team. We are also excited to have licensed Catalent’s Zydis ODT technology for use with MM-120 which we believe significantly bolsters the differentiation and protectability of our MM-120 product candidate while potentially offering enhanced bioavailability and more rapid absorption, which may lead to a shorter treatment session. We could not be more excited about the progress we have made to date and the numerous upcoming milestones in the months ahead.”
Business Update
• The Company reiterates its guidance for its cash runway, which is expected to fund its current operating plan into the first half of 2025.
• MindMed’s management team will participate in the H.C. Wainwright 25th Annual Global Investment Conference that is being held in New York, NY from September 11-13, 2023 as well as the 2023 Cantor Global Healthcare Conference being held in New York, NY from September 26-28, 2023.
Recent Highlights and Anticipated Upcoming Milestones:
Phase 2b study evaluating MM-120 for generalized anxiety disorder (GAD) remains on track for topline readout in Q4 2023.
• Patient enrollment is expected to be completed by the end of Q3 2023 with topline results for the primary endpoint expected to be announced in Q4 2023. Based on a recent review of the Company’s statistical assumptions, the target patient enrollment for the trial has been lowered from 200 to 180 participants while maintaining the statistical power (approximately 90%) to achieve the study’s objectives.
• The primary objective of the study is to determine the dose-response relationship of four doses of MM-120 versus placebo as measured by the change in Hamilton Anxiety Rating Scale (HAM-A) from baseline to week 4.
• In August 2023, MindMed announced an exclusive licensing agreement with Catalent for its patented Zydis® ODT technology for use with MM-120. The Company is also in the process of initiating a Phase 1 pharmacokinetics bridging study to support advancement of the MM-120 ODT formulation into pivotal clinical trials.
Phase 2a study evaluating MM-120 for attention deficit hyperactivity disorder (ADHD) continues to advance toward a topline readout in Q4 2023 / Q1 2024.
• The Company’s Phase 2a proof-of-concept trial for the treatment of ADHD is designed to assess the safety and efficacy of repeated low-dose MM-120 administration in 52 patients.
• The study is over 80% enrolled and on track for completion in Q4 2023.
• The Company expects to present topline results in Q4 2023 or Q1 2024.
Advancing development of MM-402 (also referred to as R(-)-MDMA) for autism spectrum disorder (ASD) into first clinical trial in Q4 2023.
• The Company plans to initiate its first clinical trial of MM-402 in Q4 2023. This Phase 1 study is intended to characterize the tolerability, pharmacokinetics and pharmacodynamics of MM-402, and to evaluate early signals of efficacy to support the Company’s approach in targeting core symptoms of ASD.
• University Hospital Basel (UHB) in Switzerland, the Company’s collaborator, is currently enrolling participants in a Phase 1 investigator-initiated trial of R(-)-MDMA, S(+)-MDMA and R/S-MDMA in healthy volunteers. This trial is designed to assess the tolerability, pharmacokinetics and acute subjective, physiological and endocrine effects of the three molecules. The Company anticipates topline results to be presented in the first half of 2024.
• In June 2023, the Company presented results from a pre-clinical study of MM-402 in a model of ASD, titled “MM-402, R(−)-3,4-Methylenedioxymethamphetamine, Demonstrates Prosocial and Ther
May 17, 2023
2 mnmd-ex99_1.htm
Exhibit 99.1
MindMed Announces Enrollment Milestone in Phase 2b Trial of MM-120 in Generalized Anxiety Disorder (GAD)
– Over 50% of patients dosed across 20 active clinical sites –
– On Track for Topline Results in late 2023 –
NEW YORK, May 17, 2023 — Mind Medicine (MindMed) Inc (NASDAQ: MNMD), (NEO: MMED), (the “Company” or “MindMed”), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, announced today that the company’s Phase 2b study evaluating MM-120 (lysergide D-tartrate) for GAD is over 50% enrolled. The trial plans to enroll up to 200 participants who will receive a single administration of 25 µg, 50 µg, 100 µg or 200 µg of MM-120 or placebo. Topline results are expected to be announced in late 2023.
“We are thrilled by the quality and efficiency with which study enrollment has progressed as we approach our expected topline data release later this year. This progress is a testament to the tireless work and dedication of all the individuals executing this study and stands out as one of the fastest recruiting efforts for this class of therapies in development,” said Robert Barrow, Chief Executive Officer and Director of MindMed. “We have seen a meaningful acceleration in enrollment over the last few months since our full set of study sites were activated early this year with 25 patients enrolled just in the last 30 days. I would like to thank our team, the study investigators and their staff and the many patients who have helped us achieve this important milestone.”
The Phase 2b trial in patients diagnosed with GAD is a multi-center, parallel, randomized, double-blind, placebo-controlled, dose-optimization study. The trial plans to enroll up to 200 participants who will be randomized to receive a single administration of 25 µg, 50 µg, 100 µg or 200 µg of MM-120 or placebo. The primary objective is to determine the reduction in anxiety symptoms 4 weeks after a single administration of MM-120, compared across the five treatment arms. Key secondary objectives, measured up to 12 weeks after the single administration, include assessments of anxiety symptoms, safety and tolerability as well as other measures of efficacy and quality of life. More information about the trial is available on our website (mindmed.co), the trial’s website (anxietyresearchstudy.com) or on clinicaltrials.gov (identifier NCT05407064).
About MindMed
MindMed is a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health disorders.
MindMed trades on NASDAQ under the symbol MNMD and on the Canadian NEO Exchange under the symbol MMED.
Certain statements in this news release related to the Company constitute “forward-looking information” within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as “will”, “may”, “should”, “could”, “intend”, “estimate”, “plan”, “anticipate”, “expect”,
“believe”, “potential” or “continue”, or the negative thereof or similar variations. Forward-looking information in this news release includes, but is not limited to, statements regarding anticipated timing of results from the Phase 2b clinical trial and the potential benefits of the Company’s product candidates. There are numerous risks and uncertainties that could cause actual results and the Company’s plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; lack of product revenue; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical trials or studies; heightened regulatory scrutiny; early stage product development; clinical trial risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; as well as those risk factors discussed or referred to herein and the risks described in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 under headings such as “Special Note Regarding Forward-Looking Statements,” and “Risk Factors” an
May 4, 2023
2 mnmd-ex99_1.htm
Exhibit 99.1
MindMed Reports First Quarter 2023 Financial Results and Business Highlights
– Key MM-120 readouts in GAD (Phase 2b) and ADHD (Phase 2a) expected by end of 2023 –
– MM-402 pre-clinical data in ASD model to be presented at ASCP 2023 Annual Meeting –
– Strengthened leadership team with appointment of Mark R. Sullivan as Chief Legal Officer –
– Cash and cash equivalents of $129.4 million at March 31, 2023 –
– Company to host conference call today at 4:30 PM ET –
NEW YORK, May 4, 2023 -- Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the “Company” or "MindMed"), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today reported its financial results for the quarter ended March 31, 2023.
“2023 is a critical year for MindMed and we are well positioned to continue advancing our R&D pipeline toward multiple near-term milestones later this year," said Robert Barrow, Chief Executive Officer and Director of MindMed. "These include key data from our Phase 2b study of MM-120 for the treatment of generalized anxiety disorder, as well as from our Phase 2a proof-of-concept trial of repeated low-dose MM-120 in attention-deficit/hyperactivity disorder. Additionally, we plan to initiate the first clinical trial of MM-402 later in the year following positive preclinical results, which we plan to present at the ASCP 2023 Annual Meeting. We made great progress throughout the first quarter and continue to remain focused on long-term value creation for our shareholders through focused and efficient execution."
Business Update
• In April 2023, Mark R. Sullivan was appointed as Chief Legal Officer. Mr. Sullivan comes to MindMed with extensive and demonstrated success as a pharmaceutical executive, with particular expertise in the areas of SEC reporting, financing, corporate governance and compliance, mergers and acquisitions, intellectual property, litigation management and business development.
• The Company reiterates its guidance for its cash runway, which is expected to fund its current operating plan into the first half of 2025.
• MindMed’s management team will participate in the RBC Capital Markets Global Healthcare Conference that is being held in New York, NY from May 16-17, 2023, the BIO International Convention being held in Boston, MA from June 5-8, 2023, the Jefferies Global Healthcare Conference that is being held in New York, NY from June 7-9, 2023 as well as the H.C. Wainwright Neuropsychiatry Conference that is being held virtually on June 26, 2023.
• The Company plans to host an analyst and investor day in the second quarter of 2023. The event will be hosted by the Company’s management team and will include a physician expert and other key opinion leaders.
Recent Highlights and Anticipated Upcoming Milestones:
Phase 2b study evaluating MM-120 for generalized anxiety disorder ("GAD") remains on track for late 2023 topline readout
• MM-120, the Company’s proprietary, pharmaceutically optimized form of lysergide D-tartrate, is being developed for the treatment of GAD.
• In August 2022, the Company initiated dosing in the 200-patient Phase 2b dose-optimization study of MM-120 for the treatment of GAD.
• Patient enrollment is currently ongoing, and the study remains on track, with topline results expected to be announced in late 2023.
Phase 2a study evaluating MM-120 for attention deficit hyperactivity disorder ("ADHD") remains on track for late 2023 topline readout
• The Company’s Phase 2a proof-of-concept trial for the treatment of ADHD is designed to assess the safety and efficacy of repeated low-dose MM-120 administration in 52 patients.
• The Company expects topline results in late 2023.
Advancing development of MM-402 into first clinical trial in 2023
• The Company is developing MM-402, the Company's proprietary form of the R-enantiomer of 3,4-Methylenedioxymethamphetamine ("MDMA"), for the treatment of core symptoms of autism spectrum disorder ("ASD").
• A late breaking abstract on the results from a pre-clinical study of MM-402 in a model of ASD, titled “MM-402, R(−)-3,4-Methylenedioxymethamphetamine, Demonstrates Prosocial and Therapeutic-Like Effects in Fmr1 Knockout mice, a Preclinical Model of Autism Spectrum Disorder (due to Fragile X syndrome)” has been accepted for presentation at the American Society of Clinical Psychopharmacology (ASCP) 2023 Annual Meeting that is being held in Miami Beach, FL from May 30-June 2, 2023.
• The Company plans to initiate its first clinical trial of MM-402 in 2023. This Phase 1 study is intended to characterize the tolerability, pharmacokinetics and pharmacodynamics of MM-402, and to evaluate early signals of efficacy to support the Company’s approach in targeting core symptoms of ASD.
• University Hospital Basel ("UHB") in Switzerland, the Company’s collaborator, is currently enrolling participants in a Phase 1 investigator-in
Mar 9, 2023
2 mnmd-ex99_1.htm
99.1
MindMed Reports Full Year 2022 Financial Results and Business Highlights
– Company positioned for key MM-120 Phase 2b data readout in GAD and Phase 2a data readout in ADHD in late 2023 –
– Company to initiate first clinical trial of MM-402 in 2023 –
– Cash and cash equivalents of $142.1 million at December 31, 2022 –
– Company to host conference call today at 4:30 PM ET –
NEW YORK, March 9, 2023 -- Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the “Company” or "MindMed"), a clinical stage biopharmaceutical company developing novel product candidates to treat brain health disorders, today reported its financial results for the full-year ended December 31, 2022.
“Our significant progress in 2022 has set the stage for what we expect to be a transformational 2023," said Robert Barrow, Chief Executive Officer and Director of MindMed. "This year we expect key data readouts from our Phase 2b study of MM-120 for the treatment of generalized anxiety disorder, as well as from our Phase 2a proof-of-concept trial of repeated low-dose MM-120 in attention-deficit/hyperactivity disorder. Additionally, we expect to initiate the first clinical trial of MM-402 later in the year. Importantly, we believe our financial position provides us with the ability to fund our programs well beyond these key milestones and into the first half of 2025. I am incredibly proud of our team’s achievements, and I am more confident than ever in our ability to continue advancing our organization and development programs. We are keenly focused on our mission to deliver novel therapies to treat brain health disorders, which we believe will lead to meaningful improvements in patient outcomes in these major areas of unmet medical need.”
Business Update
• The Company reiterates its guidance for its cash runway, which is expected to fund its current operating plan into the first half of 2025.
• MindMed’s management team will participate in the 33rd Annual Oppenheimer Healthcare Conference that is being held virtually from March 13-15, 2023 as well as the 35th Annual Roth Conference in Laguna Niguel, CA from March 12-14, 2023.
• The Company expects to host a virtual analyst and investor day in the first half of 2023. The event will be hosted by the Company’s management team and will include a physician expert and other key opinion leaders.
Recent Highlights and Anticipated Upcoming Milestones:
Phase 2b study evaluating MM-120 for generalized anxiety disorder ("GAD") remains on track
• MM-120, the Company’s proprietary, pharmaceutically optimized form of lysergide D-tartrate, is being developed for the treatment of GAD.
• In August 2022, the Company initiated dosing in the 200-patient Phase 2b dose-optimization study of MM-120 for the treatment of GAD.
• Patient enrollment is currently ongoing, and the study remains on track, with topline results expected to be announced in late 2023.
Phase 2a study evaluating MM-120 for attention deficit hyperactivity disorder ("ADHD") remains on track
• The Company’s Phase 2a proof-of-concept trial for the treatment of ADHD is designed to assess the safety and efficacy of repeated low-dose MM-120 administration in 52 patients.
• The Company expects topline results in late 2023.
Advancing development of MM-402 into first clinical trial in 2023
• The Company is developing MM-402, the Company's proprietary form of the R-enantiomer of 3,4-Methylenedioxymethamphetamine ("MDMA"), for the treatment of core symptoms of autism spectrum disorder ("ASD").
• Results from a preclinical study of MM-402 in a model of ASD are expected to be presented in the first half of 2023.
• The Company plans to initiate its first clinical trial of MM-402 in 2023. This Phase 1 study is intended to characterize the tolerability, pharmacokinetics and pharmacodynamics of MM-402, and to evaluate early signals of efficacy to support the Company’s approach in targeting core symptoms of ASD.
• University Hospital Basel ("UHB") in Switzerland, the Company’s collaborator, is currently enrolling patients in a Phase 1 investigator-initiated trial of R(-)-MDMA, S(+)-MDMA and R/S-MDMA in healthy volunteers. This trial is comparing the tolerability, pharmacokinetics and acute subjective, physiological and endocrine effects of the three molecules.
Collaborations and Partnerships
The Company continues to support its ongoing collaboration with the Liechti Lab at University Hospital Basel (“UHB”) in Switzerland. MindMed has exclusive worldwide rights to data, compounds and patent rights associated with UHB’s research on lysergide and other psychedelic compounds, including data from preclinical studies and investigator-initiated clinical trials.
In September 2022, UHB published the results of a randomized, double-blind, placebo-controlled Phase 2 study in the peer-reviewed scientific journal, Biological Psychiatry. Topline results in 46 patients with clinically significant anxiety
Nov 10, 2022
2 mnmd-ex99_1.htm
99.1
MindMed Reports Third Quarter 2022 Financial Results and Business Highlights
– Phase 2b dose-optimization trial in patients with Generalized Anxiety Disorder with first patients dosed in Q3 2022 and expect key clinical readout in late 2023 –
– Advanced IND-enabling studies for MM-402 and initiated Phase 1 investigator-initiated trial in Q3 2022 –
– Cash and cash equivalents of $154.5 million expected to fund current operating plan into first half of 2025 -
– Company to host conference call today at 8:30 AM ET –
NEW YORK, November 10, 2022 -- Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the “Company” or "MindMed"), a clinical stage biopharmaceutical company developing novel products to treat brain health disorders, today reported its financial results for the quarter ended September 30, 2022.
“We are pleased with the progress made in the third quarter as we continue executing on our core development programs (MM-120 and MM-402) and accelerating preparations for Phase 3 studies – all with the goal of bringing our treatments to market as efficiently as possible for the benefit of both patients and shareholders. During the quarter, we initiated enrollment in the largest well-controlled clinical trial of LSD, a 200-patient Phase 2b trial in patients diagnosed with Generalized Anxiety Disorder (GAD), with data expected in the second half of 2023. Additionally, we continue our efforts to bring MM-402 into human clinical studies,” said Robert Barrow, Chief Executive Officer and Director of MindMed. "Throughout the third quarter, we have taken meaningful steps to reduce our cash expenditures and we further bolstered our balance sheet, by raising approximately $60 million. We believe our strong financial position provides the Company the necessary funding to prepare for later stage clinical development of MM-120 while continuing our pursuit to retain, protect, and build the intellectual property portfolio of the Company.”
Business Update
The Company enhanced and strengthened its financial resources with approximately $60.0 million in gross proceeds as a result of sales pursuant to our at-the-market selling program and a public offering. During the quarter, the Company also regained compliance with Nasdaq’s minimum bid price listing requirement.
Development Program Updates and Anticipated Milestones:
MM-120 (LSD D-tartrate): a proprietary, pharmaceutically optimized form of lysergic acid diethylamide (LSD) that is primarily being developed for the treatment of generalized anxiety disorder (GAD).
• In August 2022, the Company initiated patient dosing in the Phase 2b dose-optimization study of MM-120 for the treatment of GAD. Patient enrollment is currently ongoing and topline results are expected in the second half of 2023.
• In September 2022, results from a Phase 2 placebo-controlled investigator-initiated clinical trial of LSD in the treatment of anxiety disorders (LSD-Assist Study) were published in the peer-reviewed scientific journal Biological Psychiatry. Topline results in 46 patients with clinically significant anxiety demonstrated the significant, rapid, durable, and beneficial effects of LSD and its potential to safely mitigate symptoms of anxiety and depression.
• Enrollment is ongoing for Study MMED007, a Phase 2a proof-of-concept trial for the treatment of ADHD. The study is designed to assess the safety and efficacy of repeated low-dose MM-120 administration. The Company expects topline results in the second half of 2023.
• The Company continues to prioritize and focus its current development efforts and resources on MM-120 in psychiatric indications. MindMed currently owns and retains all clinical data and manufacturing rights for MM-120 and is aggressively protecting and expanding its intellectual property portfolio.
MM-402 or R(-)-MDMA: a synthetic R-enantiomer of 3,4-Methylenedioxymethamphetamine
(MDMA) that the Company is developing for the treatment of core symptoms of autism spectrum disorder.
• IND-enabling studies are currently ongoing and initiation of a Phase 1 clinical trial of MM-402 is planned in 2023.
• A Phase 1 pharmacokinetic/pharmacodynamic investigator-initiated trial of R(-)-MDMA, S(+)-MDMA and R/S-MDMA in healthy volunteers is currently underway through the Company’s collaboration with the University Hospital Basel in Switzerland.
Third Quarter 2022 Financial and Other Recent Highlights
Cash Balance. As of September 30, 2022, MindMed had cash and cash equivalents totaling $154.5 million compared to $133.5 million as of December 31, 2021. MindMed believes its available cash and cash equivalents will be sufficient to meet its operating requirements into the first half of 2025.
Net Cash in Operating Activities. The net cash used in operating activities was $37.3 million for the nine months ended September 30, 2022, compared to $38.0 million for the same period in 2021.
Research and Development (R&D)
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