--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--
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).
- 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 $243.1 million compared to $99.7 million as of
December 31, 2023. The Company recently 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.
The Company believes that its cash and cash equivalents as of
June 30, 2024, plus the approximately $70.0 million in net proceeds
from the recently completed offering 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 six months ended
June 30, 2024, net cash used in operating activities was $36.6
million, compared to $27.2 million in the six months ended June 30,
2023.
Research and Development (R&D). R&D expenses were $14.7
million for the quarter ended June 30, 2024, compared to $14.8
million for the quarter ended June 30, 2023, a decrease of $0.1
million. The decrease was primarily due to decreases of $0.5
million in expenses related to our MM120 program, and a decrease of
$2.0 million in expenses related to preclinical activities,
partially offset by an increase of $1.0 million in internal
personnel costs as a result of increasing research and development
capacities, and an increase of $1.4 million in expenses related to
our MM402 program.
General and Administrative (G&A). G&A expenses were $9.8
million for the quarter ended June 30, 2024, compared to $14.4
million for the quarter ended June 30, 2023, a decrease of $4.6
million. The decrease was primarily attributable to professional
services fees and expenses during the three months ended June 30,
2023 related to the proxy contest in connection with our 2023
annual general meeting of shareholders, partially offset by
increased stock-based compensation expense.
Net Loss. Net loss for the quarter ended June 30, 2024, was $5.9
million, compared to $29.1 million for the same period in 2023. The
decrease was primarily due to changes in the fair value of 2022 USD
Financing Warrants of $15.0 million.
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 U.S. Food & Drug Administration (FDA) has
designated MM120 for GAD as a breakthrough therapy. MM120 is
entering a Phase 3 clinical program for GAD in the second half of
2024 and a Phase 3 clinical program for MDD in the first half of
2025 with additional clinical indications under exploration.
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 Canada which are available under the
Company's profile on SEDAR+ at www.sedarplus.ca and with the U.S.
Securities and Exchange Commission on EDGAR at www.sec.gov. Except
as required by law, the Company undertakes no duty or obligation to
update any forward-looking statements contained in this release as
a result of new information, future events, changes in expectations
or otherwise.
Mind Medicine (MindMed)
Inc.
Condensed Consolidated
Statements of Operations and Comprehensive Loss
(Unaudited)
(In thousands, except share
and per share amounts)
Three Months Ended June
30,
Six Months Ended June
30,
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
(unaudited)
December 31, 2023
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
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Mind Medicine MindMed (NASDAQ:MNMD)
過去 株価チャート
から 7 2024 まで 8 2024
Mind Medicine MindMed (NASDAQ:MNMD)
過去 株価チャート
から 8 2023 まで 8 2024
