MindMed Reports Third Quarter 2024 Financial Results and Business Updates
MindMed (NASDAQ: MNMD) reported Q3 2024 financial results and provided updates on its clinical programs. The company is preparing to launch three Phase 3 studies, including the Voyage study for GAD in Q4 2024, with topline data expected in H1 2026. Cash position stands at $295.3 million, expected to fund operations into 2027. Q3 2024 saw R&D expenses of $17.2 million and net loss of $13.7 million. The company's MM120 ODT program is advancing with additional Phase 3 studies Panorama (GAD) and Emerge (MDD) planned for H1 2025, targeting conditions affecting approximately 51 million U.S. adults.
MindMed (NASDAQ: MNMD) ha riportato i risultati finanziari del terzo trimestre del 2024 e fornito aggiornamenti sui suoi programmi clinici. L'azienda si sta preparando a lanciare tre studi di Fase 3, inclusa lo studio Voyage per il GAD nel quarto trimestre del 2024, con i dati preliminari attesi nella prima metà del 2026. La posizione di cassa è di 295,3 milioni di dollari, prevista per finanziare le operazioni fino al 2027. Nel terzo trimestre del 2024, le spese per R&S sono state di 17,2 milioni di dollari e la perdita netta di 13,7 milioni di dollari. Il programma MM120 ODT dell'azienda sta avanzando con ulteriori studi di Fase 3, Panorama (GAD) ed Emerge (MDD) pianificati per la prima metà del 2025, mirando a condizioni che colpiscono circa 51 milioni di adulti negli Stati Uniti.
MindMed (NASDAQ: MNMD) informó los resultados financieros del tercer trimestre de 2024 y proporcionó actualizaciones sobre sus programas clínicos. La empresa se está preparando para lanzar tres estudios de Fase 3, incluido el estudio Voyage para el GAD en el cuarto trimestre de 2024, con datos preliminares esperados para la primera mitad de 2026. La posición de efectivo asciende a 295.3 millones de dólares, esperando financiar operaciones hasta 2027. En el tercer trimestre de 2024, los gastos de I+D fueron de 17.2 millones de dólares y la pérdida neta fue de 13.7 millones de dólares. El programa MM120 ODT de la empresa avanza con estudios adicionales de Fase 3, Panorama (GAD) y Emerge (MDD) planeados para la primera mitad de 2025, dirigidos a condiciones que afectan a aproximadamente 51 millones de adultos en EE. UU.
MindMed (NASDAQ: MNMD)는 2024년 3분기 재무 결과를 보고하고 임상 프로그램에 대한 업데이트를 제공했습니다. 이 회사는 2024년 4분기에 GAD를 위한 Voyage 연구를 포함한 3개의 3상 연구를 출시할 준비를 하고 있으며, 주요 데이터는 2026년 상반기에 예상됩니다. 현금 보유고는 2억 9,530만 달러로, 2027년까지 운영 자금을 지원할 것으로 예상됩니다. 2024년 3분기 R&D 비용은 1,720만 달러였고, 순손실은 1,370만 달러였습니다. 회사의 MM120 ODT 프로그램은 2025년 상반기를 목표로 하는 추가 3상 연구인 Panorama (GAD) 및 Emerge (MDD)와 함께 진전되고 있으며, 이는 약 5,100만 명의 미국 성인에게 영향을 미치는 질환을 목표로 하고 있습니다.
MindMed (NASDAQ: MNMD) a rapporté les résultats financiers du troisième trimestre 2024 et a fourni des mises à jour sur ses programmes cliniques. L'entreprise se prépare à lancer trois études de Phase 3, y compris l'étude Voyage pour le GAD au quatrième trimestre 2024, avec des données préliminaires attendues au premier semestre 2026. La position de trésorerie s'élève à 295,3 millions de dollars, prévue pour financer les opérations jusqu'en 2027. Au troisième trimestre 2024, les dépenses de R&D étaient de 17,2 millions de dollars et la perte nette de 13,7 millions de dollars. Le programme MM120 ODT de l'entreprise avance avec d'autres études de Phase 3, Panorama (GAD) et Emerge (MDD) prévues pour le premier semestre 2025, visant des conditions touchant environ 51 millions d'adultes aux États-Unis.
MindMed (NASDAQ: MNMD) hat die Finanzzahlen für das 3. Quartal 2024 veröffentlicht und Updates zu seinen klinischen Programmen bereitgestellt. Das Unternehmen bereitet sich darauf vor, drei Phase-3-Studien zu starten, einschließlich der Voyage-Studie für GAD im 4. Quartal 2024, mit Ergebnissen, die für das 1. Halbjahr 2026 erwartet werden. Die Liquiditätsposition beläuft sich auf 295,3 Millionen Dollar, die voraussichtlich die Geschäftstätigkeit bis 2027 finanzieren werden. Im 3. Quartal 2024 lagen die F&E-Ausgaben bei 17,2 Millionen Dollar und der Nettverlust bei 13,7 Millionen Dollar. Das MM120 ODT-Programm des Unternehmens schreitet voran, mit weiteren Phase-3-Studien, Panorama (GAD) und Emerge (MDD), die für das 1. Halbjahr 2025 geplant sind und Bedingungen ansprechen, die etwa 51 Millionen Erwachsene in den USA betreffen.
- Strong cash position of $295.3 million, sufficient to fund operations into 2027
- Net loss decreased by $4.2 million to $13.7 million compared to Q3 2023
- G&A expenses decreased by $0.8 million compared to Q3 2023
- R&D expenses increased by $4.0 million compared to Q3 2023
- Net cash used in operating activities increased to $53.8 million from $43.8 million YoY
Insights
The Q3 results show a robust financial position with
The advancement to Phase 3 trials represents a significant milestone in psychedelic medicine development. The comprehensive trial design includes adaptive sample sizing and clear endpoints using established scales (HAM-A for anxiety and MADRS for depression). The multi-pronged approach targeting both GAD and MDD with MM120 ODT shows strategic diversification. The completion of MM402's Phase 1 study for ASD also demonstrates pipeline progression. The planned trials' structure, with 12-week double-blind periods followed by 40-week extensions, provides robust data collection opportunities for safety and efficacy assessment.
--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
--Company to host a conference call today at 4:30 p.m. EST--
“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
Program Updates and Anticipated Milestones
MM120 (lysergide D-tartrate) for GAD
- The Company is on track to initiate the Phase 3 Voyage study of MM120 ODT, a pharmaceutically optimized form of lysergide D-tartrate (LSD) for the treatment of adults with GAD in the fourth quarter of 2024. The Company expects the topline readout from the 12-week double-blind period (Part A) of Voyage in the first half of 2026.
-
The Phase 3 clinical program for MM120 ODT in GAD consists of two clinical studies: the Voyage study (MM120-300) and the Panorama study (MM120-301).
- Both studies are comprised of two parts: Part A, which is a 12-week, randomized, double-blind, placebo-controlled, parallel group study assessing the efficacy and safety of MM120 ODT versus placebo; and Part B, which is a 40-week extension period during which participants will be eligible for open-label treatment with MM120 ODT, subject to certain conditions for treatment eligibility.
-
Voyage is anticipated to enroll approximately 200 participants in the
U.S. who will be randomized 1:1 to receive MM120 ODT 100 µg or placebo, and Panorama is anticipated to enroll approximately 240 participants (randomized 5:2:5 to receive MM120 ODT 100 µg, MM120 ODT 50 µg or placebo). - The primary endpoint for each study is the change from baseline in Hamilton Anxiety Rating Scale (HAM-A) score at Week 12 between MM120 ODT 100 µg and placebo.
-
Both studies are expected to employ an adaptive design with interim blinded sample size re-estimation based on nuisance parameters (e.g. participant retention rate, variability of primary outcome measure) which allows for an increase of sample size up to
50% to maintain statistical power.
-
Panorama, the second Phase 3 study, will be conducted in the
U.S. andEurope and is on track to initiate in the first half of 2025 with an anticipated topline readout from the 12-week double-blind period (Part A) in the second half of 2026.
MM120 (lysergide D-tartrate) for MDD
-
The Company is also developing MM120 ODT for the treatment of adults with MDD, beginning with the Emerge study (MM120-310) which, like the Phase 3 studies in GAD, is comprised of two parts: Part A, which is a 12-week, randomized, double-blind, placebo-controlled, parallel-group study assessing the efficacy and safety of MM120 ODT versus placebo; and Part B, which is a 40-week extension period during which participants will be eligible for open-label treatment with MM120 ODT, subject to certain conditions for treatment eligibility.
- Emerge is anticipated to enroll at least 140 participants (randomized 1:1 to receive MM120 ODT 100 µg or placebo).
-
The primary endpoint is the change from baseline in
Montgomery -Åsberg Depression Rating Scale (MADRS) score at Week 6 between MM120 ODT 100 µg and placebo. - The Company expects to initiate Emerge in the first half of 2025 with an anticipated topline readout from the 12-week double-blinded period (Part A) in the second half of 2026.
- The Company expects to conduct a second Phase 3 registrational study in MDD, with the study design and timing to be informed by the progress of Emerge and additional regulatory discussion.
MM402 (R(-)-MDMA) for Autism Spectrum Disorder (ASD)
- In October, the Company completed a Phase 1 study of MM402, a single-ascending dose study in adult healthy volunteers. The study was intended to characterize the tolerability, pharmacokinetics and pharmacodynamics of MM402. The Company expects to initiate further studies of MM402 for the potential treatment of ASD, with the exact timing and scope of such studies to be determined.
Third Quarter 2024 Financial Results
Cash Balance. As of September 30, 2024, MindMed had cash and cash equivalents totaling
The Company believes that its cash and cash equivalents as of September 30, 2024, will be sufficient to fund the Company’s operations into 2027. Based on the Company’s current operating plan and anticipated R&D milestones, the Company expects its cash runway to extend at least 12 months beyond its first Phase 3 topline data readout for MM120 ODT in GAD.
Net Cash Used in Operating Activities. For the nine months ended September 30, 2024, net cash used in operating activities was
Research and Development (R&D). R&D expenses were
General and Administrative (G&A). G&A expenses were
Net Loss. Net loss for the quarter ended September 30, 2024, was
Conference Call and Webcast Reminder
MindMed management will host a conference call at 4:30 PM EST today to provide a corporate update and review the Company’s third quarter 2024 financial results. Listeners can register for the webcast via this link. Analysts wishing to participate in the question-and-answer session should use this link. A replay of the webcast will be available via the Investor Relations section of the MindMed website, ir.mindmed.co and archived for at least 30 days after the webcast. Those who plan on participating are advised to join 15 minutes prior to the start time.
About MM120
MM120 (lysergide D-tartrate or LSD) is a synthetic ergotamine belonging to the group of classic, or serotonergic, psychedelics, which acts as a partial agonist at human serotonin-2A (5-hydroxytryptamine-2A [5-HT2A]) receptors. MindMed is developing MM120, the tartrate salt form of lysergide, for GAD and MDD and is exploring its potential applications in other serious brain health disorders. Based on the significant unmet medical need in the treatment of GAD – especially in patients who do not respond to or tolerate currently available medications – along with the initial clinical data from Phase 2b and other research conducted by MindMed, the
About MM402
MM402 is the Company’s proprietary form of R(-)-MDMA (rectus-3,4-methylenedioxymethamphetamine), being developed for the treatment of core symptoms of ASD. MDMA is a synthetic molecule that is often referred to as an empathogen because it is reported to increase feelings of connectedness and compassion. Preclinical studies of R(-)-MDMA demonstrate its acute pro-social and empathogenic effects, while its diminished dopaminergic activity suggest that it has the potential to exhibit less stimulant activity, neurotoxicity, hyperthermia and abuse liability compared to racemic MDMA or the S(+)-enantiomer.
About MindMed
MindMed is a clinical-stage biopharmaceutical company developing novel product candidates to treat brain health disorders. Our mission is to be the global leader in the development and delivery of treatments that unlock new opportunities to improve patient outcomes. We are developing a pipeline of innovative product candidates, with and without acute perceptual effects, targeting neurotransmitter pathways that play key roles in brain health. MindMed trades on NASDAQ under the symbol MNMD.
Forward-Looking Statements
Certain statements in this news release related to the Company constitute "forward-looking information" within the meaning of applicable securities laws and are prospective in nature. Forward-looking information is not based on historical facts, but rather on current expectations and projections about future events and are therefore subject to risks and uncertainties which could cause actual results to differ materially from the future results expressed or implied by the forward-looking statements. These statements generally can be identified by the use of forward-looking words such as "will", "may", "should", "could", "intend", "estimate", "plan", "anticipate", "expect", "believe", "potential" or "continue", or the negative thereof or similar variations. Forward-looking information in this news release includes, but is not limited to, statements regarding the Company’s expectation to initiate the Phase 3 Voyage study of MM120 ODT in GAD in the fourth quarter of 2024 with an anticipated topline readout (Part A results) in the first half of 2026; the Company’s expectation to initiate the Phase 3 Panorama study for MM120 ODT in GAD in the first half of 2025 with an anticipated topline readout (Part A results) in the second half of 2026; the Company’s expectation to initiate the Phase 3 Emerge study for MM120 ODT in MDD in the first half of 2025 with an anticipated topline readout (Part A results) in the second half of 2026; the Company’s plans to conduct a second Phase 3 study in MDD; the Company’s expectations regarding the enrollment for each of the Voyage, Panorama and Emerge studies; the Company’s beliefs regarding potential benefits of its product candidates; the Company’s expectation to conduct further studies of MM402; the Company’s expectation that its cash and cash equivalents will fund operations into 2027; the Company’s expectation that its cash runway will extend at least 12 months beyond its first Phase 3 topline data readout for MM120 ODT in GAD; the Company’s anticipated upcoming milestones, trials and studies; and potential additional indications for MM120 and MM402. There are numerous risks and uncertainties that could cause actual results and the Company's plans and objectives to differ materially from those expressed in the forward-looking information, including history of negative cash flows; limited operating history; incurrence of future losses; availability of additional capital; compliance with laws and regulations; difficulty associated with research and development; risks associated with clinical studies or studies; heightened regulatory scrutiny; early stage product development; clinical study risks; regulatory approval processes; novelty of the psychedelic inspired medicines industry; 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, 2023 under headings such as "Special Note Regarding Forward-Looking Statements," and "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" and other filings and furnishings made by the Company with the securities regulatory authorities in all provinces and territories of
Mind Medicine (MindMed) Inc. Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (In thousands, except share and per share amounts) |
||||||||||||||||
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
||||||||||||
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
||||||||
Research and development |
|
$ |
17,188 |
|
|
$ |
13,203 |
|
|
$ |
43,538 |
|
|
$ |
40,578 |
|
General and administrative |
|
|
7,604 |
|
|
|
8,413 |
|
|
|
27,916 |
|
|
|
31,083 |
|
Total operating expenses |
|
|
24,792 |
|
|
|
21,616 |
|
|
|
71,454 |
|
|
|
71,661 |
|
Loss from operations |
|
|
(24,792 |
) |
|
|
(21,616 |
) |
|
|
(71,454 |
) |
|
|
(71,661 |
) |
Other income/(expense): |
|
|
|
|
|
|
|
|
||||||||
Interest income |
|
|
3,507 |
|
|
|
1,491 |
|
|
|
8,279 |
|
|
|
4,240 |
|
Interest expense |
|
|
(727 |
) |
|
|
(328 |
) |
|
|
(1,627 |
) |
|
|
(481 |
) |
Foreign exchange loss, net |
|
|
(32 |
) |
|
|
(439 |
) |
|
|
(589 |
) |
|
|
(244 |
) |
Change in fair value of 2022 USD Financing Warrants |
|
|
8,360 |
|
|
|
3,020 |
|
|
|
(11,088 |
) |
|
|
(3,671 |
) |
Gain on extinguishment of contribution payable |
|
|
— |
|
|
|
— |
|
|
|
2,541 |
|
|
|
— |
|
Other expense |
|
|
— |
|
|
|
(51 |
) |
|
|
— |
|
|
|
(51 |
) |
Total other income/(expense), net |
|
|
11,108 |
|
|
|
3,693 |
|
|
|
(2,484 |
) |
|
|
(207 |
) |
Net loss |
|
|
(13,684 |
) |
|
|
(17,923 |
) |
|
|
(73,938 |
) |
|
|
(71,868 |
) |
Other comprehensive loss |
|
|
|
|
|
|
|
|
||||||||
Gain/(loss) on foreign currency translation |
|
|
(12 |
) |
|
|
415 |
|
|
|
478 |
|
|
|
150 |
|
Comprehensive loss |
|
$ |
(13,696 |
) |
|
$ |
(17,508 |
) |
|
$ |
(73,460 |
) |
|
$ |
(71,718 |
) |
Net loss per common share, basic |
|
$ |
(0.18 |
) |
|
$ |
(0.45 |
) |
|
$ |
(1.12 |
) |
|
$ |
(1.85 |
) |
Net loss per common share, diluted |
|
$ |
(0.27 |
) |
|
$ |
(0.45 |
) |
|
$ |
(1.12 |
) |
|
$ |
(1.85 |
) |
Weighted-average common shares, basic |
|
|
77,909,441 |
|
|
|
39,720,007 |
|
|
|
65,938,025 |
|
|
|
38,798,374 |
|
Weighted-average common shares, diluted |
|
|
80,238,688 |
|
|
|
39,720,007 |
|
|
|
65,938,025 |
|
|
|
38,798,374 |
|
Mind Medicine (MindMed) Inc. Condensed Consolidated Balance Sheets (In thousands, except share amounts) |
||||||||
|
|
September 30, 2024 (Unaudited) |
|
|
December 31, 2023 |
|
||
Assets |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
295,284 |
|
|
$ |
99,704 |
|
Prepaid and other current assets |
|
|
4,074 |
|
|
|
4,168 |
|
Total current assets |
|
|
299,358 |
|
|
|
103,872 |
|
Goodwill |
|
|
19,918 |
|
|
|
19,918 |
|
Intangible assets, net |
|
|
— |
|
|
|
527 |
|
Other non-current assets |
|
|
493 |
|
|
|
224 |
|
Total assets |
|
$ |
319,769 |
|
|
$ |
124,541 |
|
|
|
|
|
|
|
|
||
Liabilities and Shareholders’ Equity |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
2,149 |
|
|
$ |
4,136 |
|
Accrued expenses |
|
|
8,796 |
|
|
|
11,634 |
|
2022 USD Financing Warrants |
|
|
22,320 |
|
|
|
16,476 |
|
Total current liabilities |
|
|
33,265 |
|
|
|
32,246 |
|
Credit facility, long-term |
|
|
24,311 |
|
|
|
14,129 |
|
Other liabilities, long-term |
|
|
— |
|
|
|
32 |
|
Total liabilities |
|
|
57,576 |
|
|
|
46,407 |
|
|
|
|
|
|
|
|
||
Shareholders' Equity: |
|
|
|
|
|
|
||
Common shares, no par value, unlimited authorized as of September 30, 2024 and December 31, 2023; 81,590,491 and 41,101,303 issued and outstanding as of September 30, 2024 and December 31, 2023, respectively |
|
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
|
625,510 |
|
|
|
367,991 |
|
Accumulated other comprehensive income |
|
|
821 |
|
|
|
343 |
|
Accumulated deficit |
|
|
(364,138 |
) |
|
|
(290,200 |
) |
Total shareholders' equity |
|
|
262,193 |
|
|
|
78,134 |
|
Total liabilities and shareholders' equity |
|
$ |
319,769 |
|
|
$ |
124,541 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20241107702200/en/
For Media: media@mindmed.co
For Investors: ir@mindmed.co
Source: Mind Medicine Inc.
FAQ
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