--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--
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.
- 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.
- 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.
- 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.
- 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.
- 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:
- European Psychiatric Association (EPA) 2024 Congress
- Anxiety & Depression Association of America (ADAA) 2024
Conference
- American Psychiatric Association (APA) 2024 Congress
- 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 9-11 in
Austin, Texas.
- This trial was conducted by the Company’s collaborators at
University Hospital Basel (UHB) in Switzerland and extends on the
previously reported positive findings from the LSD-Assist study
presented in May 2022.
- The Company plans to hold an End-of-Phase 2 meeting with FDA in
the second quarter[DK1] of 2024 and is on track to initiate its
Phase 3 clinical program of MM120 Zydis® ODT for the treatment of
GAD in the second half of 2024.
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. It 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.
- UHB has conducted a Phase 1 investigator-initiated trial of
R(-)-MDMA, S(+)-MDMA and R/S- MDMA in healthy adult volunteers.
This trial was designed to assess the tolerability,
pharmacokinetics and acute subjective, physiological and endocrine
effects of the three molecules. Topline results are anticipated to
be presented in the second quarter of 2024.
First Quarter 2024 Financial
Results
Cash Balance. As of March 31, 2024, MindMed had cash and cash
equivalents totaling $252.3 million compared to $99.7 million as of
December 31, 2023. The Company believes its available cash and cash
equivalents will be sufficient to fund its operations into 2026
based on its current operating plan.
Net Cash Used in Operating Activities. For the quarter ended
March 31, 2024, net cash used in operating activities was $16.6
million, compared to $13.3 million in the quarter ended March 31,
2023.
Research and Development (R&D). R&D expenses were $11.7
million for the quarter ended March 31, 2024, compared to $12.6
million for the quarter ended March 31, 2023, a decrease of $0.9
million. The decrease was primarily due to decreases of $0.6
million in expenses related to our MM402 program, a decrease of
$0.5 million in expenses related to preclinical activities,
partially offset by an increase of $0.3 million in internal
personnel costs as a result of increasing research and development
capacities.
General and Administrative (G&A). G&A expenses were
$10.5 million for the quarter ended March 31, 2024, compared to
$8.3 million for the quarter ended March 31, 2023, an increase of
$2.2 million. The increase was primarily attributable to increased
stock-based compensation expense of $1.1 million and an increase of
$0.7 million in personnel-related expenses due to an increase in
headcount to support the growth of our business.
Net Loss. Net loss for the quarter ended March 31, 2024 was
$54.4 million, compared to $24.8 million for the quarter ended
March 31, 2023. The increase was primarily due to changes in the
fair value of 2022 USD Financing Warrants of $27.7 million.
CFO Transition
On May 3, 2024, the Company made a transition in the role of
Chief Financial Officer resulting in the departure of Schond
Greenway. “On behalf of the Board of Directors and Executive team,
I would like to thank Schond for all his hard work and dedication
over the past two years,” said Robert Barrow, Chief Executive
Officer and Director of MindMed. “Schond supported the Company
through several significant milestones and has left us well
positioned financially and strategically. As we continue to
progress our development pipeline and advance preparations for the
potential commercialization of MM120, we are committed to
identifying leaders that will continue the Company’s recent
momentum and deliver long-term value to shareholders.”
MindMed has retained an executive search firm to assist in
identifying a new Chief Financial Officer.
Conference Call and Webcast
Reminder
MindMed management will host a conference call at 4:30 PM EDT
today to provide a corporate update and review the Company’s first
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
Lysergide is a synthetic tryptamine 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 (lysergide D-tartrate), the
tartrate salt form of lysergide, for GAD and other psychiatric
indications.
About MM402
MM402 is our proprietary form of R(-)-MDMA
(rectus-3,4-methylenedioxymethamphetamine), which we are developing
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 drug
candidates, with and without acute perceptual effects, targeting
the serotonin, dopamine, and acetylcholine systems.
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
belief that results from its Phase 1 pharmacokinetics bridging
trial will support the advancement of its MM120 ODT formulation
into pivotal clinical trials; the Company’s belief that it is on
track to initiate a Phase 3 clinical program for MM120 Zydis® ODTs
in the second half of 2024; 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 Company’s plans to hold an
End-of-Phase 2 meeting with the FDA in the second quarter of 2024;
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
topline results from UHB’s Phase 1 investigator-initiated clinical
trial of R(-)-MDMA, S(+)-MDMA and R/S- MDMA will be presented in
the second quarter of 2024; the Company’s expectation that its cash
and cash equivalents are expected to fund operations into 2026;
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 March 31,
2024
2023
Operating expenses:
Research and development
$
11,705
$
12,599
General and administrative
10,499
8,263
Total operating expenses
22,204
20,862
Loss from operations
(22,204
)
(20,862
)
Other income/(expense):
Interest income
1,656
1,360
Interest expense
(434
)
(76
)
Foreign exchange loss, net
(525
)
(52
)
Change in fair value of 2022 USD Financing
Warrants
(32,893
)
(5,185
)
Total other expense, net
(32,196
)
(3,953
)
Net loss
(54,400
)
(24,815
)
Other comprehensive loss
Gain on foreign currency translation
493
14
Comprehensive loss
$
(53,907
)
$
(24,801
)
Net loss per common share, basic and
diluted
$
(1.14
)
$
(0.65
)
Weighted-average common shares, basic and
diluted
47,860,757
38,077,251
Mind Medicine (MindMed)
Inc.
Condensed Consolidated Balance
Sheets
(Unaudited)
(In thousands, except share
amounts)
March 31, 2024
(unaudited)
December 31,
2023
Assets
Current assets:
Cash and cash equivalents
$
252,332
$
99,704
Prepaid and other current assets
3,139
4,168
Total current assets
255,471
103,872
Goodwill
19,918
19,918
Intangible assets, net
—
527
Other non-current assets
144
224
Total assets
$
275,533
$
124,541
Liabilities and Shareholders’
Equity
Current liabilities:
Accounts payable
$
7,595
$
4,136
Accrued expenses
9,974
11,634
2022 USD Financing Warrants
47,700
16,476
Total current liabilities
65,269
32,246
Credit facility, long-term
14,190
14,129
Other liabilities, long-term
15
32
Total liabilities
79,474
46,407
Shareholders' Equity:
Common shares, no par value, unlimited
authorized as of March 31, 2024 and December 31, 2023; 71,163,720
and 41,101,303 issued and outstanding as of March 31, 2024 and
December 31, 2023, respectively
—
—
Additional paid-in capital
539,823
367,991
Accumulated other comprehensive income
836
343
Accumulated deficit
(344,600
)
(290,200
)
Total shareholders' equity
196,059
78,134
Total liabilities and shareholders'
equity
$
275,533
$
124,541
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