--Announced statistically significant and
clinically meaningful topline Phase 2b data for MM120 at 4 weeks in
Generalized Anxiety Disorder (GAD)--
--Multiple planned milestones for MM120 in GAD,
including 12-week Phase 2b data to be presented at March 7th
investor event, and initiation of Phase 3 clinical program in
second half of 2024--
--Initiated Phase 1 clinical trial of MM402 in
Autism Spectrum Disorder (ASD)--
--Conference call to discuss year-end financial
results at 8:00 a.m. EST--
Mind Medicine (MindMed) Inc. (NASDAQ:MNMD), (Cboe Canada:MMED),
(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 year ended
December 31, 2023 and provided a business update.
“2023 was a highly productive year for MindMed, which concluded
with positive Phase 2b results for MM120 in the treatment of adult
patients with GAD,” said Rob Barrow, Chief Executive Officer and
Director of the Company. “We believe the initial data we shared
validates our scientific understanding of MM120’s mechanism of
action and shows the potential to have a best-in-class product
profile compared to today’s standard of care. We look forward to
sharing 12-week safety, efficacy, and durability data and results
from our Phase 1 pharmacokinetics bridging trial to support the
advancement of our MM120 oral dissolving tablet (ODT) formulation
into pivotal clinical trials at our virtual investor event in
March. Looking further into 2024, we anticipate several additional
milestones, including one-year follow-up results from an
investigator-initiated clinical trial of lysergide in anxiety
disorders conducted by our collaborators at University Hospital
Basel. We will be working closely with the FDA to finalize our
Phase 3 development program for MM120 in GAD and expect to hold our
End-of-Phase 2 meeting with the FDA in the first half of the year.
This is intended to enable the initiation of our Phase 3 clinical
program in the second half of the year.”
Business Update
- The Company will host a virtual investor event on March 7, 2024
to provide 12-week data from the Phase 2 program for MM120 being
developed for the treatment of GAD. Senior management and key
opinion leaders will discuss the treatment landscape, market
potential and commercial opportunity for MM120 in GAD and other
psychiatric disorders.
Program Updates and Anticipated
Milestones
MM120 (lysergide D-tartrate) for GAD
- In December 2023, the Company announced statistically
significant and clinically meaningful topline 4- week data from the
198-patient Phase 2b dose-optimization trial of MM120 for the
treatment of GAD.
- MM120 100 µg – the dose achieving the highest level of clinical
activity – demonstrated a 7.6- point reduction on the Hamilton
Anxiety rating scale (HAM-A) compared to placebo at Week 4 (-21.3
MM120 vs. -13.7 placebo; p<0.0004; Cohen’s d effect size=0.88),
which is more than double the effect sizes seen with the current
standards of care1.
- Clinical response (50% or greater improvement in HAM-A) at Week
4 was achieved in 78% of participants treated with MM120 (100 µg or
200 µg) compared to 31% for placebo.
- Clinical remission (HAM-A≤ 7) at Week 4 was achieved in 50% of
participants treated with MM120 100 µg compared to 18% for
placebo.
- The Company plans to share topline 12-week safety, efficacy,
and durability results from the Phase 2b study and results from its
pharmacokinetics bridging trial of the MM120 Zydis® ODT
formulation, its intended commercial formulation of MM120, at an
upcoming virtual investor event on March 7, 2024.
- The Company anticipates that full results from the Phase 2b
trial of MM120 in GAD will be presented at a scientific meeting in
2024.
- The Company plans to hold an End-of-Phase 2 meeting with the
FDA in the first half of 2024 and expects to initiate its Phase 3
clinical program in the second half of 2024.
- One-year follow-up data from a Phase 2 placebo-controlled
investigator-initiated clinical trial of lysergide in the treatment
of anxiety disorders is anticipated in 2024. This trial was
conducted by the Company’s collaborators at University Hospital
Basel (UHB) in Switzerland and completed in Q3 2023.
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 and 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.
- In October 2023, the Company presented results from a
nonclinical study in a model of ASD, titled “MM402 demonstrates
better efficacy than S(+)-3,4-MDMA or (±)-3,4-MDMA in Fmr1 knockout
mice, an animal model of autism spectrum disorder” at the 36th
Annual European College of Neuropsychopharmacology (ECNP)
Congress.
- UHB is currently conducting a Phase 1 investigator-initiated
trial of R(-)-MDMA, S(+)-MDMA and R/S- MDMA in healthy adult
volunteers. This trial is designed to assess the tolerability,
pharmacokinetics and acute subjective, physiological and endocrine
effects of the three molecules. The Company anticipates topline
results to be presented in the first half of 2024.
2023 Financial Results
Cash Balance. As of December 31, 2023, MindMed had cash and cash
equivalents totaling $99.7 million compared to $142.1 million as of
December 31, 2022. The Company believes its available cash and cash
equivalents as well as its committed credit facility are expected
to fund operations into 2026, if certain milestones are achieved
that unlock additional capital.
Net Cash Used in Operating Activities. For the year ended
December 31, 2023, net cash used in operating activities was $64.4
million, compared to $50.1 million for the year ended December 31,
2022.
Research and Development (R&D). R&D expenses were $52.1
million for the year ended December 31, 2023, compared to $36.2
million for the year ended December 31, 2022, an increase of $15.9
million. The increase was primarily due to increases of $16.1
million in expenses related to clinical research and product
development for the MM120 GAD Phase 2b clinical trial, and $2.6
million in internal personnel costs as a result of increasing
research and development capacities, offset by a decrease of $0.7
million in expenses related to our MM402 program, a decrease of
$0.8 million in expenses related to various external research and
development collaborations, and a decrease of $1.2 million in
expenses related to preclinical activities and the MM110
program.
General and Administrative (G&A). G&A expenses were
$41.7 million for the year ended December 31, 2023, compared to
$30.2 million for the year ended December 31, 2022, an increase of
$11.5 million. The increase was primarily attributable to
professional services fees and expenses related to the proxy
contest in connection with our 2023 annual general meeting of
shareholders and costs to support the growth of our business.
Net Loss. Net loss for the year ended December 31, 2023 was
$95.7 million, compared to $56.8 million for the year ended
December 31, 2022.
Conference Call and Webcast
Reminder
MindMed management will host a conference call at 8:00 AM EST
today to provide a corporate update and review the Company’s 2023
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.
MindMed trades on NASDAQ under the symbol MNMD and on the
Canadian Cboe Exchange under the symbol MMED.
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 anticipated
upcoming milestones, trials and studies; results and timing of and
reporting of topline data from clinical trials, including the
Company’s expectations to announce 12- week data from its Phase 2b
clinical trial for MM120 in GAD at its upcoming investor day; the
Company’s expectations to share results from its Phase 1
pharmacokinetics bridging trial of the MM120 Zydis® ODT formulation
at its upcoming investor day; the Company’s expectation that
follow-up data from UHB’s Phase 2 placebo-controlled
investigator-initiated clinical trial will be released in 2024; the
potential benefits of the Company’s product candidates; potential
additional psychiatric indications for MM120; the timing of a
potential End-of-Phase 2 meeting with the FDA; the timing of a
potential Phase 3 clinical trial for MM120 in GAD; the Company’s
expectations to present data from the Phase 2b trial for MM120 at a
scientific meeting in 2024; the Company’s expectation that topline
results from UHB’s Phase 1 investigator initiated trial will be
presented in the first half of 2024; and the Company’s expectation
that its cash and cash equivalents are expected to fund operations
into 2026, if certain milestones are achieved that unlock
additional capital. 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.
__________________________ 1 Source: RB Hidalgo, J
Psychopharmacol. 2007 Nov;21(8):864-72.
Mind Medicine (MindMed)
Inc.
Consolidated Statements of
Operations and Comprehensive Loss
(In thousands, except share
and per share amounts)
Years Ended December
31,
2023
2022
Operating expenses:
Research and development
$
52,124
$
36,169
General and administrative
41,742
30,162
Total operating expenses
93,866
66,331
Loss from operations
(93,866
)
(66,331
)
Other income/(expense):
Interest income, net
4,664
1,495
Foreign exchange gain, net
157
195
Change in fair value of 2022 USD Financing
Warrants
(6,636
)
7,843
Other (expense)/income
(51
)
2
Total other (expense)/income, net
(1,866
)
9,535
Net loss
(95,732
)
(56,796
)
Other comprehensive loss:
Loss on foreign currency translation
(284
)
(419
)
Comprehensive loss
$
(96,016
)
$
(57,215
)
Net loss per common share, basic and
diluted
$
(2.44
)
$
(1.84
)
Weighted-average common shares, basic and
diluted (Note 2)
39,157,420
30,857,463
Mind Medicine (MindMed)
Inc.
Consolidated Balance
Sheets
(In thousands, except share
amounts)
December 31,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$
99,704
$
142,142
Prepaid and other current assets
4,168
3,913
Total current assets
103,872
146,055
Goodwill
19,918
19,918
Intangible assets, net
527
3,689
Other non-current assets
224
331
Total assets
$
124,541
$
169,993
Liabilities and Shareholders’
Equity
Current liabilities:
Accounts payable
$
4,136
$
2,111
Accrued expenses
11,634
5,877
2022 USD Financing Warrants
16,476
9,904
Total current liabilities
32,246
17,892
Credit facility, long-term
14,129
—
Other liabilities, long-term
32
1,184
Total liabilities
46,407
19,076
Shareholders' Equity:
Common shares, no par value, unlimited
authorized as of December 31, 2023 and 2022; 41,101,303 and
37,979,136 issued and outstanding as of December 31, 2023 and 2022,
respectively
—
—
Additional paid-in capital
367,991
344,758
Accumulated other comprehensive income
343
627
Accumulated deficit
(290,200
)
(194,468
)
Total shareholders' equity
78,134
150,917
Total liabilities and shareholders'
equity
$
124,541
$
169,993
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