MindMed Reports Second Quarter 2024 Financial Results and Business Updates
MindMed (NASDAQ: MNMD) reported Q2 2024 financial results and provided business updates. Key highlights include:
1. Completed End-of-Phase 2 meeting with FDA for MM120 ODT in GAD
2. Phase 3 clinical program for MM120 ODT in GAD to start in H2 2024
3. Expanding pipeline with MM120 ODT for MDD, registrational study planned for H1 2025
4. New patent extends MM120 ODT IP protection through 2041
5. $243.1M cash balance as of June 30, 2024
6. Recently closed $75M gross proceeds offering
7. Cash runway extended into 2027
Financial results: R&D expenses $14.7M, G&A expenses $9.8M, net loss $5.9M for Q2 2024. The company expects its first Phase 3 clinical readout for MM120 ODT in GAD in H1 2026.
MindMed (NASDAQ: MNMD) ha riportato i risultati finanziari del Q2 2024 e fornito aggiornamenti aziendali. I punti salienti includono:
1. Completato l'incontro End-of-Phase 2 con la FDA per MM120 ODT in GAD
2. Inizio del programma clinico di Fase 3 per MM120 ODT in GAD previsto per il secondo semestre del 2024
3. Espansione del pipeline con MM120 ODT per MDD, studio registrativo pianificato per il primo semestre del 2025
4. Nuovo brevetto che estende la protezione IP di MM120 ODT fino al 2041
5. Saldo di cassa di $243.1M al 30 giugno 2024
6. Recentemente chiuso un'offerta di proventi lordi di $75M
7. Estensione della disponibilità di cassa fino al 2027
Risultati finanziari: spese per R&D $14.7M, spese per G&A $9.8M, perdita netta di $5.9M per il Q2 2024. L'azienda prevede il suo primo readout clinico di Fase 3 per MM120 ODT in GAD nel primo semestre del 2026.
MindMed (NASDAQ: MNMD) reportó los resultados financieros del Q2 2024 y proporcionó actualizaciones comerciales. Los aspectos destacados incluyen:
1. Reunión de fin de fase 2 completa con la FDA para MM120 ODT en GAD
2. Programa clínico de fase 3 para MM120 ODT en GAD comenzará en el segundo semestre de 2024
3. Expansión de la cartera con MM120 ODT para MDD, estudio de registro planificado para el primer semestre de 2025
4. Nueva patente que extiende la protección de propiedad intelectual de MM120 ODT hasta 2041
5. Saldo de efectivo de $243.1M al 30 de junio de 2024
6. Oferta de ingresos brutos de $75M cerrada recientemente
7. Camino de efectivo extendido hasta 2027
Resultados financieros: gastos de I+D $14.7M, gastos generales y administrativos $9.8M, pérdida neta de $5.9M para el Q2 2024. La empresa espera su primer resultado clínico de fase 3 para MM120 ODT en GAD en el primer semestre de 2026.
MindMed (NASDAQ: MNMD)는 2024년 2분기 재무 결과를 발표하고 사업 업데이트를 제공했습니다. 주요 하이라이트는 다음과 같습니다:
1. GAD에 대한 MM120 ODT와 관련하여 FDA와의 임상 2상 종료 미팅 완료
2. 2024년 하반기에 GAD를 위한 MM120 ODT의 3상 임상 프로그램 시작 예정
3. 2025년 상반기에 MDD를 위한 MM120 ODT의 등록 연구 계획 중
4. 새로운 특허가 MM120 ODT의 지적 재산 보호를 2041년까지 연장
5. 2024년 6월 30일 기준 현금 잔고 $243.1M
6. 최근 $75M의 총 수익 제공 완료
7. 2027년까지 현금 운영 연장
재무 결과: R&D 비용 $14.7M, G&A 비용 $9.8M, 2024년 2분기 순손실 $5.9M. 회사는 2026년 상반기에 GAD를 위한 MM120 ODT의 첫 번째 3상 임상 결과를 기대하고 있습니다.
MindMed (NASDAQ: MNMD) a publié ses résultats financiers pour le deuxième trimestre 2024 et fourni des mises à jour commerciales. Les points clés incluent:
1. Réunion de fin de phase 2 achevée avec la FDA pour MM120 ODT dans le GAD
2. Le programme clinique de phase 3 pour MM120 ODT dans le GAD devrait commencer au deuxième semestre 2024
3. Expansion du pipeline avec MM120 ODT pour le MDD, étude d'enregistrement prévue pour le premier semestre 2025
4. Nouveau brevet prolongeant la protection de la propriété intellectuelle de MM120 ODT jusqu'en 2041
5. Solde de trésorerie de 243,1 millions de dollars au 30 juin 2024
6. Offre de produits bruts de 75 millions de dollars récemment clôturée
7. Durée de trésorerie prolongée jusqu'en 2027
Résultats financiers : dépenses de R&D de 14,7 millions de dollars, dépenses générales de 9,8 millions de dollars, perte nette de 5,9 millions de dollars pour le deuxième trimestre 2024. L'entreprise s'attend à son premier résultat clinique de phase 3 pour MM120 ODT dans le GAD au premier semestre 2026.
MindMed (NASDAQ: MNMD) hat die Finanzzahlen für das zweite Quartal 2024 veröffentlicht und Unternehmensupdates bereitgestellt. Wichtige Highlights sind:
1. Abschluss des End-of-Phase-2-Meetings mit der FDA für MM120 ODT in GAD
2. Das klinische Programm der Phase 3 für MM120 ODT in GAD wird im zweiten Halbjahr 2024 beginnen
3. Erweiterung der Pipeline mit MM120 ODT für MDD, Registrierungsstudie für das erste Halbjahr 2025 geplant
4. Neues Patent verlängert den IP-Schutz von MM120 ODT bis 2041
5. Barguthaben von 243,1 Millionen Dollar zum 30. Juni 2024
6. Kürzlich abgeschlossenes Angebot mit brutto 75 Millionen Dollar
7. Cash-Ressourcen bis 2027 verlängert
Finanzergebnisse: F&E-Ausgaben 14,7 Millionen Dollar, Allgemeine Verwaltungskosten 9,8 Millionen Dollar, Nettoverlust von 5,9 Millionen Dollar für das zweite Quartal 2024. Das Unternehmen erwartet, dass es im ersten Halbjahr 2026 den ersten klinischen Bericht der Phase 3 für MM120 ODT in GAD veröffentlicht.
- Successful completion of End-of-Phase 2 meeting with FDA for MM120 ODT in GAD
- Phase 3 clinical program for MM120 ODT in GAD on track to start in H2 2024
- Expansion of pipeline with MM120 ODT for MDD, registrational study planned for H1 2025
- New patent extends MM120 ODT intellectual property protection through 2041
- Strong cash position of $243.1M as of June 30, 2024
- Recently closed $75M gross proceeds offering
- Cash runway extended into 2027, at least 12 months beyond first Phase 3 clinical readout
- Decrease in net loss from $29.1M in Q2 2023 to $5.9M in Q2 2024
- Increase in net cash used in operating activities from $27.2M in H1 2023 to $36.6M in H1 2024
- Slight increase in R&D expenses related to MM402 program and internal personnel costs
Insights
MindMed's Q2 2024 results reveal a strong financial position with
MindMed's pipeline progress is noteworthy. The company is advancing MM120 ODT into Phase 3 trials for GAD in H2 2024, with topline results expected in H1 2026. They're also expanding into MDD, planning to initiate a registrational study in H1 2025. The FDA alignment on Phase 3 requirements for GAD and the new patent extending protection for MM120 ODT through 2041 are significant milestones. These developments, coupled with the ongoing Phase 1 trial of MM402 for Autism Spectrum Disorder, demonstrate a diversified and advancing clinical portfolio targeting major unmet needs in mental health.
MindMed's strategic focus on GAD and MDD with MM120 ODT positions them well in the growing psychedelic medicine market. The company's robust cash position and extended runway provide a competitive advantage in this capital-intensive field. The new patent strengthens their market protection strategy, potentially leading to a strong commercial position if trials succeed. However, investors should note the long timeline to potential commercialization, with key readouts not expected until 2026. The company's delisting from Cboe Canada to focus on Nasdaq listing may impact liquidity for some investors but could attract more U.S.-based institutional investors.
--Completed End-of-Phase 2 (EOP2) meeting with the
--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--
“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
Business Update
-
Completed an underwriting offering of its common shares and pre-funded warrants to purchase common shares for
in gross proceeds before deducting transaction fees and other offering related expenses.$75.0 million - 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).
- 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.
- 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).
- 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.
-
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. - 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: 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.
- 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 (Part A results) in the second half of 2026. The Company expects to conduct a second registrational study in MDD with the study design and timing to be informed by Emerge and additional regulatory discussion.
MM402 (R(-)-MDMA) for Autism Spectrum Disorder (ASD)
- MM402 is being evaluated in a Phase 1, single-ascending dose trial in adult healthy volunteers intended to characterize its tolerability, pharmacokinetics and pharmacodynamics. Results from this trial are expected to 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.
Second Quarter 2024 Financial Results
Cash Balance. As of June 30, 2024, MindMed had cash and cash equivalents totaling
The Company believes that its cash and cash equivalents as of June 30, 2024, plus the approximately
Net Cash Used in Operating Activities. For the six months ended June 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 June 30, 2024, was
Conference Call and Webcast Reminder
MindMed management will host a conference call at 8:00 AM EDT today to provide a corporate update and review the Company’s second 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, https://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 (LSD or lysergide D-tartrate) 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 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 disorders. 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 Voyage Study in the second half of 2024 with an anticipated topline readout (Part A results) in the first half of 2026; the Company’s expectation to initiate the Panorama Study 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 Emerge Study 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 provide additional updates on its GAD program and other product candidates in its pipeline; the Company’s beliefs regarding potential benefits of its product candidates; the potential IP protection for MM120; the Company’s belief that its Phase 1 trial for MM402 (R(-)-MDMA) 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; the Company’s expectation that its cash and cash equivalents plus the gross proceeds from the recently completed offering will fund operations into 2027; the Company’s expectation that its cash runway will extend at least 12 months beyond the topline data readout for its VOYAGE Phase 3 trial of MM120 in GAD; anticipated upcoming milestones, trials and studies; results and timing of and reporting of data from clinical trials; 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 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, 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
|
|
|
Six Months
|
|
||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Research and development |
|
$ |
14,645 |
|
|
$ |
14,777 |
|
|
$ |
26,350 |
|
|
$ |
27,375 |
|
General and administrative |
|
|
9,813 |
|
|
|
14,407 |
|
|
|
20,312 |
|
|
|
22,670 |
|
Total operating expenses |
|
|
24,458 |
|
|
|
29,184 |
|
|
|
46,662 |
|
|
|
50,045 |
|
Loss from operations |
|
|
(24,458 |
) |
|
|
(29,184 |
) |
|
|
(46,662 |
) |
|
|
(50,045 |
) |
Other income/(expense): |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Interest income |
|
|
3,116 |
|
|
|
1,388 |
|
|
|
4,772 |
|
|
|
2,748 |
|
Interest expense |
|
|
(466 |
) |
|
|
(77 |
) |
|
|
(900 |
) |
|
|
(153 |
) |
Foreign exchange gain/(loss), net |
|
|
(32 |
) |
|
|
247 |
|
|
|
(557 |
) |
|
|
195 |
|
Change in fair value of 2022 USD Financing Warrants |
|
|
13,445 |
|
|
|
(1,504 |
) |
|
|
(19,448 |
) |
|
|
(6,690 |
) |
Gain on extinguishment of contribution payable |
|
|
2,541 |
|
|
|
— |
|
|
|
2,541 |
|
|
|
— |
|
Total other income/(expense), net |
|
|
18,604 |
|
|
|
54 |
|
|
|
(13,592 |
) |
|
|
(3,900 |
) |
Net loss |
|
|
(5,854 |
) |
|
|
(29,130 |
) |
|
|
(60,254 |
) |
|
|
(53,945 |
) |
Other comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
||||
Gain/(loss) on foreign currency translation |
|
|
(3 |
) |
|
|
(279 |
) |
|
|
490 |
|
|
|
(265 |
) |
Comprehensive loss |
|
$ |
(5,857 |
) |
|
$ |
(29,409 |
) |
|
$ |
(59,764 |
) |
|
$ |
(54,210 |
) |
Net loss per common share, basic |
|
$ |
(0.08 |
) |
|
$ |
(0.76 |
) |
|
$ |
(1.01 |
) |
|
$ |
(1.41 |
) |
Net loss per common share, diluted |
|
$ |
(0.26 |
) |
|
$ |
(0.76 |
) |
|
$ |
(1.01 |
) |
|
$ |
(1.41 |
) |
Weighted-average common shares, basic |
|
|
71,912,323 |
|
|
|
38,576,394 |
|
|
|
59,886,540 |
|
|
|
38,329,919 |
|
Weighted-average common shares, diluted |
|
|
75,304,101 |
|
|
|
38,576,394 |
|
|
|
59,886,540 |
|
|
|
38,329,919 |
|
Mind Medicine (MindMed) Inc. Condensed Consolidated Balance Sheets (In thousands, except share amounts) |
||||||||
|
|
June 30, 2024
|
|
|
December 31,
|
|
||
Assets |
|
|
|
|
|
|
||
Current assets: |
|
|
|
|
|
|
||
Cash and cash equivalents |
|
$ |
243,132 |
|
|
$ |
99,704 |
|
Prepaid and other current assets |
|
|
4,561 |
|
|
|
4,168 |
|
Total current assets |
|
|
247,693 |
|
|
|
103,872 |
|
Goodwill |
|
|
19,918 |
|
|
|
19,918 |
|
Intangible assets, net |
|
|
— |
|
|
|
527 |
|
Other non-current assets |
|
|
534 |
|
|
|
224 |
|
Total assets |
|
$ |
268,145 |
|
|
$ |
124,541 |
|
|
|
|
|
|
|
|
||
Liabilities and Shareholders’ Equity |
|
|
|
|
|
|
||
Current liabilities: |
|
|
|
|
|
|
||
Accounts payable |
|
$ |
2,936 |
|
|
$ |
4,136 |
|
Accrued expenses |
|
|
8,231 |
|
|
|
11,634 |
|
2022 USD Financing Warrants |
|
|
30,680 |
|
|
|
16,476 |
|
Total current liabilities |
|
|
41,847 |
|
|
|
32,246 |
|
Credit facility, long-term |
|
|
24,251 |
|
|
|
14,129 |
|
Other liabilities, long-term |
|
|
— |
|
|
|
32 |
|
Total liabilities |
|
|
66,098 |
|
|
|
46,407 |
|
|
|
|
|
|
|
|
||
Commitments and contingencies |
|
|
|
|
|
|
||
Shareholders' Equity: |
|
|
|
|
|
|
||
Common shares, no par value, unlimited authorized as of June 30, 2024 and December 31, 2023; 72,075,076 and 41,101,303 issued and outstanding as of June 30, 2024 and December 31, 2023, respectively |
|
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
|
551,668 |
|
|
|
367,991 |
|
Accumulated other comprehensive income |
|
|
833 |
|
|
|
343 |
|
Accumulated deficit |
|
|
(350,454 |
) |
|
|
(290,200 |
) |
Total shareholders' equity |
|
|
202,047 |
|
|
|
78,134 |
|
Total liabilities and shareholders' equity |
|
$ |
268,145 |
|
|
$ |
124,541 |
|
View source version on businesswire.com: https://www.businesswire.com/news/home/20240813926656/en/
For Media: media@mindmed.co
For Investors: ir@mindmed.co
Source: Mind Medicine Inc.
FAQ
When will MindMed (MNMD) start its Phase 3 clinical program for MM120 ODT in GAD?
What is MindMed's (MNMD) cash balance as of June 30, 2024?
When does MindMed (MNMD) expect topline results from its Phase 3 trial for MM120 ODT in GAD?
What is MindMed's (MNMD) expected cash runway?