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
--Company to host a conference call today at
“This is a pivotal moment for MindMed as we prepare to initiate Voyage, our first Phase 3 study of MM120 ODT in GAD,” said
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
The Company believes that its cash and cash equivalents as of
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
Conference Call and Webcast Reminder
MindMed management will host a conference call at
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
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (In thousands, except share and per share amounts) |
||||||||||||||||
|
|
Three Months Ended
|
|
Nine Months Ended
|
||||||||||||
|
|
|
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 |
|
Condensed Consolidated Balance Sheets (In thousands, except share amounts) |
||||||||
|
|
2024 (Unaudited) |
|
|
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 |
|
|
|
|
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 |
|
|
— |
|
|
|
— |
|
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: