- Advanced clinical programs for three lead
drug candidates -
- Strengthened leadership team with the
appointment of Francois Lilienthal,
MD as Chief Commercial Officer -
- Cash runway through key clinical readouts in
2023 and into 2024 -
- Company to host conference call today at
8:30 AM ET -
NEW
YORK, May 16, 2022 /CNW/ -- Mind Medicine
(MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED), (the "Company"), a
clinical stage biopharmaceutical company developing novel products
to treat brain health disorders, today reported its financial
results for the quarter ended March 31,
2022.
![Mindmed logo (PRNewsfoto/Mind Medicine, Inc. (Mindmed)) Mindmed logo (PRNewsfoto/Mind Medicine, Inc. (Mindmed))](https://mma.prnewswire.com/media/996320/Mindmed_Logo.jpg)
"The outset of 2022 was marked by significant progress across
all aspects of the company that propelled our business forward, as
we continued to advance and de-risk our three lead product
candidates: MM-120 for the treatment of generalized anxiety
disorder, MM-402 for the treatment of core symptoms of autism
spectrum disorder, and MM-110 for the management of opioid use
disorder," said Robert Barrow, Chief
Executive Officer and Director of MindMed. "We anticipate multiple
upcoming catalysts and further growth across our drug development
pipeline as well as our enabling technologies. We look forward to
building on this momentum and believe we are well positioned to
deliver on the therapeutic potential of psychedelics and other
novel targets to transform the treatment of brain health
disorders."
Recent Highlights and Anticipated Upcoming Milestones
MM-120 (LSD D-tartrate): a proprietary, pharmaceutically
optimized form of lysergic acid diethylamide (LSD) that is being
developed for the treatment of generalized anxiety disorder (GAD).
MM-120 is also being studied under various dosing regimens for the
treatment of adult attention deficit hyperactivity disorder (ADHD)
and for the treatment of chronic pain.
- Study MMED008, a Phase 2b
dose-optimization trial of MM-120 for the treatment of GAD, was
initiated.
- In December 2021, Study MMED007,
a Phase 2a proof-of-concept trial, was initiated for the treatment
of ADHD. The study is designed to assess the safety and efficacy of
repeated low-dose MM-120 administration.
- A Phase 2a trial of MM-120 in a chronic pain condition is
expected to initiate in Q4 2022.
MM-110 (zolunicant HCl or 18-MC): a congener of ibogaine that
the Company is developing for the treatment of opioid withdrawal.
MM-110 is an α3β4 nicotinic cholinergic receptor antagonist that
has been tested in preclinical models of withdrawal and substance
use disorders.
- In December 2021, the Company
completed MMED003, a Phase 1 trial of MM-110. In this study, 77
participants received up to 325 mg of MM-110 twice (on a single
day) or were administered up to 90mg of MM-110 twice daily for
seven days, and 31 participants received a placebo.
- The results of this successful Phase 1 study have informed the
Phase 2a trial design that is expected to be initiated in Q2
2022.
- In May 2022, the Company
announced an upcoming webinar on substance use disorders and
withdrawal management featuring presentations from noted experts in
the field, Kelly E. Dunn, PhD, MBA,
Professor, Johns Hopkins School of
Medicine and Stuart Gitlow,
MD, MPH, MBA, Past President of the American Society of Addiction
Medicine. Following presentations by Drs. Dunn and Gitlow, the
MindMed leadership team will provide an overview of MM-110 and its
potential to address a critical gap in current treatment of opioid
use disorder.
MM-402 or R(-)-MDMA: a synthetic R-enantiomer of MDMA that
exhibits feelings of connectedness and compassion that the Company
is developing for the treatment of core symptoms of autism spectrum
disorder. Preclinical studies of R(-)-MDMA demonstrate its acute
prosocial effects, while its diminished dopaminergic activity
suggests that it may exhibit less stimulant activity,
neurotoxicity, hyperthermia and abuse liability profile when
compared to racemic MDMA or the S(+)-enantiomer of MDMA.
- IND-enabling studies are currently ongoing and, through the
Company's collaboration with University Hospital Basel, a
comparative Phase 1 pharmacokinetic/pharmacodynamic trial of
R(-)-MDMA, S(+)-MDMA and (+)- MDMA in healthy volunteers is
expected to commence in Q3 2022.
Digital Medicine Initiatives
MindMed Session Monitoring System (MSMS): technological platform
and product that provides the foundation for the development and
implementation of a suite of regulated and unregulated products for
use by clinicians and patients during treatment sessions that may
also include the use of consciousness altering
medications.
- Session Monitoring System (SMS-01): The study is designed to
evaluate the passive collection of sensory data during a
consciousness-altering therapeutic session using the MSMS.
- Anxiety Digital Diagnoses for Precision Psychiatry (ADDAPT,
MMED-D001): The newly developed mobile application to support the
study is currently in private beta, enrolling by invitation.
- Quantifying the Processes and Events of Psychotherapy at Scale
(MM061302): The study remains on track and is continuing to enroll
and collect data.
Collaborations and Partnerships
- In May 2022, Dr. Frederike Holze and Prof. Dr. Matthias Liechti, MindMed collaborators at
University Hospital Basel (UHB), presented results from the
LSD-Assist Study, a Phase 2 placebo-controlled
investigator-initiated clinical trial of LSD in the treatment of
anxiety disorders, at London's
PSYCH Symposium.
- Preliminary topline safety and efficacy results for LSD in 46
patients with clinically significant anxiety demonstrated the
significant, rapid, durable, and beneficial effects of LSD and
potential to safely mitigate symptoms of anxiety and
depression.
Leadership Additions
- In April 2022, Francois Lilienthal, MD was appointed as Chief
Commercial Officer. With more than two decades of global
biopharmaceutical experience, Dr. Lilienthal will step into this
role to support the advancement of the Company's clinical and
commercial objectives.
First Quarter 2022 Financial and Other Recent
Highlights
Cash Balance. As of March 31,
2022, MindMed had cash totaling $120.5 million compared to $133.5 million as of December 31, 2021. MindMed believes its available
cash will be sufficient to meet its operating requirements beyond
its key development milestones in 2023 and into 2024.
Net Cash in Operating Activities. The net cash used
in operating activities was $12.9
million for the three months ended March 31, 2022, compared to $10.0 million for the same period in 2021.
Research and Development (R&D). R&D expenses
were $10.2 million for the three
months ended March 31, 2022, compared
to $6.8 million for the same period
in 2021. The increase of $3.4 million
was primarily due to $4.4 million of
internal expenses related to compensation costs for additional
headcount of $2.0 million and an
increase in non-cash expenses of $1.7
million of stock-based compensation expenses. This increase
was offset by a decrease in external spending of $0.8 million related to our preclinical and other
programs.
General and Administrative (G&A).
G&A expenses were $8.3
million for the three months ended March 31, 2022, compared to $7.0 million for the same period in 2021. The
increase of $1.2 million was
primarily due to an increase of $0.9
million in non-cash stock-based compensation expenses. Other
contributors to the increase included higher professional service
expenses including accounting, audit, legal, compliance, director
and officer insurance, and investor and public relations and
personnel costs to support the growth of the company.
Net Loss. The net and comprehensive loss for the
three months ended March 31, 2022,
was $18.5 million, compared to
$13.8 million for the same period in
2021.
Conference Call and Webcast Reminder
MindMed management will host a conference call at 8:30 AM EDT today to provide a corporate update
and review the Company's first quarter 2022 financial results.
Individuals may participate in the call via telephone by dialing
(877) 407-0789 (domestic) or (201) 689-8562 (international) and
using conference ID 13728028. The webcast can be accessed live here
or on MindMed's Investor Resources webpage. The webcast will be
archived on the Company's website for at least 30 days after the
conference call.
About MindMed
MindMed is a clinical-stage biopharmaceutical company developing
novel products to treat brain health disorders, with a particular
focus on psychiatry, addiction, pain and neurology. 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 NEO 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
include, but are not limited to, statements regarding anticipated
upcoming milestones and studies, results and timing of clinical
studies, expected growth and developments of drugs and
technologies, continuing collaborations and partnerships, and the
availability of cash and cash equivalents. 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; lack of product revenue;
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 year
ended December 31, 2021 and its
Quarterly Report on Form 10-Q for the period ended March 31, 2022 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.sedar.com 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.
For Media: media@mindmed.co
For Investors: ir@mindmed.co
Mind Medicine
(MindMed) Inc.
Condensed
Consolidated Statements of Operations and Comprehensive
Loss
(Unaudited)
(In thousands,
except share and per share amounts)
|
|
|
|
For the
Three Months
Ended
March 31,
2022
|
|
|
For the
Three Months
Ended
March 31,
2021
|
|
Operating
expenses:
|
|
|
|
|
|
|
Research and development
|
|
$
|
10,241
|
|
|
$
|
6,813
|
|
General and administrative
|
|
|
8,264
|
|
|
|
7,035
|
|
Total operating
expenses
|
|
|
18,505
|
|
|
|
13,848
|
|
Loss from
operations
|
|
|
(18,505)
|
|
|
|
(13,848)
|
|
Other income
(expense):
|
|
|
|
|
|
|
Interest expense, net
|
|
|
(27)
|
|
|
|
(87)
|
|
Foreign exchange gain, net
|
|
|
45
|
|
|
|
8
|
|
Other income
|
|
|
36
|
|
|
|
168
|
|
Total other income,
net
|
|
|
54
|
|
|
|
89
|
|
Net loss
|
|
|
(18,451)
|
|
|
|
(13,759)
|
|
Other comprehensive
gain/(loss):
|
|
|
|
|
|
|
{Loss}/gain on foreign currency translation
|
|
|
(49)
|
|
|
|
59
|
|
Comprehensive
loss
|
|
$
|
(18,500)
|
|
|
$
|
(13,700)
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(0.04)
|
|
|
$
|
(0.04)
|
|
Weighted-average common
shares, basic and diluted
|
|
|
422,212,489
|
|
|
|
389,575,029
|
|
Mind Medicine (MindMed) Inc.
Condensed Consolidated Balance
Sheets
(In thousands, except share
amounts)
|
|
|
|
March 31,
|
|
|
December 31,
|
|
|
|
|
2022
|
|
|
2021
|
|
|
|
|
(unaudited)
|
|
|
|
|
|
Assets
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash
|
|
$
|
120,472
|
|
|
$
|
133,539
|
|
|
Prepaid and other current assets
|
|
|
2,755
|
|
|
|
3,676
|
|
|
Total current assets
|
|
|
123,227
|
|
|
|
137,215
|
|
|
Goodwill
|
|
|
19,918
|
|
|
|
19,918
|
|
|
Intangible assets,
net
|
|
|
6,089
|
|
|
|
6,869
|
|
|
Total assets
|
|
$
|
149,234
|
|
|
$
|
164,002
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Shareholders'
Equity
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts payable
|
|
$
|
3,332
|
|
|
$
|
4,178
|
|
|
Accrued expenses
|
|
|
7,227
|
|
|
|
6,230
|
|
|
Total current
liabilities
|
|
|
10,559
|
|
|
|
10,408
|
|
|
Contribution payable,
long-term
|
|
|
1,870
|
|
|
|
1,930
|
|
|
Total
liabilities
|
|
|
12,429
|
|
|
|
12,338
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shareholders'
Equity:
|
|
|
|
|
|
|
|
Subordinate voting shares, no par value, unlimited
authorized as
of
March 31, 2022 and December 31, 2021;
422,401,776 and 421,444,157 issued and
outstanding as of March 31, 2022 and
December
2021, respectively
|
|
|
—
|
|
|
|
—
|
|
|
Multiple voting shares, no par value, unlimited
authorized as of
March 31, 2022 and December 31, 2021;
none and
4,521 issued and
outstanding as of March 31, 2022 and
December 31,
2021, respectively
|
|
|
—
|
|
|
|
—
|
|
|
Additional paid-in capital
|
|
|
291,931
|
|
|
|
288,290
|
|
|
Accumulated other comprehensive income
|
|
|
997
|
|
|
|
1,046
|
|
|
Accumulated deficit
|
|
|
(156,123)
|
|
|
|
(137,672)
|
|
|
Total shareholders'
equity
|
|
|
136,805
|
|
|
|
151,664
|
|
|
Total liabilities and
shareholders' equity
|
|
$
|
149,234
|
|
|
$
|
164,002
|
|
|
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SOURCE Mind Medicine (MindMed) Inc.