- FDA cleared MindMed's Investigational New
Drug (IND) application for Phase 2b
dose optimization trial of MM-120 -
- Progressed development programs for all
three lead product candidates -
- Cash balance of $133.5 million at year end 2021 -
- Company to host earnings conference call
today at 8:30 AM EDT -
NEW
YORK, March 28, 2022 /PRNewswire/ -- Mind
Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED) (the
"Company" or "MindMed"), a clinical stage biopharmaceutical company
developing novel products to treat brain health disorders, today
reported its financial results for the full-year ended December 31, 2021.
"2021 was a year of major advancements across all aspects of
MindMed, with significant growth in our organization, development
programs and research collaborations. We established a regulatory
pathway for MM-120 in the treatment of GAD and, with MM-402,
launched a program to develop a novel treatment for core symptoms
of autism spectrum disorder – both of which represent meaningful
leaps forward in the field of psychiatry," said Robert Barrow, Chief Executive Officer and
Director of MindMed. "We expect 2022 to be a transformational year
in which we continue to drive substantial growth across our
pharmaceutical and digital medicine pipelines. I am incredibly
proud of our team's achievements and I am more confident than ever
in our ability to continue advancing our organization and
development programs. We are keenly focused on our mission to
deliver novel therapies to treat brain health disorders, leading to
meaningful improvements in patient outcomes in these major areas of
unmet medical need."
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.
- In January 2022, the U.S. Food
and Drug Administration (FDA) cleared the Company's Investigational
New Drug (IND) application for the Phase 2b dose-optimization trial of MM-120 for the
treatment of GAD.
-
- Study MMED008, a Phase 2b
dose-optimization study of MM-120 for the treatment of GAD, is
expected to begin in Q2 2022.
- In December 2021, Study MMED007,
a Phase 2a proof-of-concept study, 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 clinical study of MM-120 in a chronic pain condition is
expected to be initiated in Q4 2022.
MM-110 (zolunicant HCl or 18-MC): a derivative 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 extensively tested in preclinical models
of substance use disorders.
- In January 2022, the USAN Council
assigned the non-proprietary name "zolunicant" (pronounced: zoe
lun' i kant), to MM-110 or 18-MC.
- In December 2021, the Company
completed a Phase 1 study of MM-110 with topline data expected in
Q2 2022. These results will inform the design of the planned Phase
2a study in individuals undergoing standardized supervised opioid
withdrawal, which is expected to commence in Q2 2022. The Phase 2a
study will evaluate the safety, tolerability and efficacy of MM-110
in mitigating symptoms of opioid withdrawal and facilitating
completion of detoxification.
MM-402 (R(-)-MDMA): a synthetic enantiomer of MDMA that
exhibits prosocial and empathogenic activity 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 a favorable safety, tolerability 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 study of R(-),
S(+) and + MDMA is expected to commence in mid 2022.
Digital Medicine
Initiatives
- In February 2021, the Company
completed the acquisition of HealthMode and fully integrated its
team to enable rapid progression of digital medicine and business
operations functions.
- Having engaged in a productive Pre-Submission meeting with FDA
in late 2021, in January 2022, the
first subjects were enrolled into the Session Monitoring System
(SMS-01) study evaluating the passive collection of sensory data
during a consciousness-altering therapeutic session using the
MindMed Session Monitoring System (MSMS).
- Anxiety Digital Diagnoses for Precision Psychiatry (ADDAPT,
MMED-D001): A Natural History Study and our newly developed mobile
application to support the study is expected to launch in private
beta in Q2 2022.
- In September 2021, the first
participants were enrolled by invitation in the Quantifying the
Processes and Events of Psychotherapy at Scale (MM061302)
study.
Collaborations and
Partnerships
- University Hospital Basel (UHB): The Company continued to
support the ongoing collaboration with the Liechti Lab at UHB in
Switzerland. MindMed has exclusive
worldwide rights to data, compounds and patent rights associated
with the Liechti laboratory's research with LSD and other
psychedelic compounds, including data from preclinical studies and
over 15 completed and 9 ongoing clinical trials.
-
- In March 2022, the peer-reviewed
publication of a double-blind placebo-controlled comparative study
of LSD and psilocybin was published in
Neuropsychopharmacology. The study demonstrated that the key
differences between LSD and psilocybin are dose-dependent rather
than substance-dependent. These findings have the potential to
assist with dose-finding, trial design and inform future studies
evaluating the therapeutic utility of psychedelics.
- In November 2021, the
peer-reviewed publication of a randomized, double-blind,
placebo-controlled study evaluating the interacting effects of an
SSRI and psilocybin in healthy volunteers was published in
Clinical Pharmacology and Therapeutics. The study suggests
psilocybin is safe to take in combination with an SSRI.
- Nextage Therapeutics Ltd: The Company entered into a
collaboration with Nextage Therapeutics in April 2021 to explore the therapeutic potential
of noribogine in a proprietary brain targeted liposome drug
delivery technology system to mitigate risks of peripheral adverse
effects.
- MindShift Compounds AG: The Company continued to progress its
collaborative research and development activities with MindShift
Compounds AG in Basel,
Switzerland, focusing on the discovery and optimization of
next generation compounds, including those with and without acute
perceptual effects.
- The Chopra Foundation: The company ultimately did not reach a
definitive agreement for a potential collaboration and discontinued
the engagement.
Director & Officer
Appointments
- In December 2021, Robert Barrow was appointed as Chief Executive
Officer and as a member of the Board of Directors. Mr. Barrow
previously served as interim Chief Executive Officer and Chief
Development Officer of MindMed and brings strategic expertise and
deep industry insight to his role.
- In December 2021, Cynthia Hu, JD was appointed as Chief Legal
Officer and Corporate Secretary.
- In November 2021, Carrie Liao, CPA was appointed as VP, Corporate
Controller and Principal Accounting Officer.
- In September 2021, Carol Vallone and Andreas Krebs were appointed to the Board of
Directors and were subsequently appointed as chair and vice chair,
respectively.
- In May 2021, Sarah Vinson, MD was appointed to the Board of
Directors.
- In February 2021, Daniel Karlin, MD, MA was appointed as Chief
Medical Officer.
Scientific Advisory Board
Appointments
- Over the course of 2021, we made significant additions to our
Scientific Advisory Board (SAB), including:
-
- Robert C. Malenka, MD, PhD
(Professor, Stanford University) – SAB
chair
- Maurizio Fava, MD
(Psychiatrist-In-Chief, Mass General Hospital; Associate Dean and
Professor of Psychiatry, Harvard Medical
School)
- Peter Bergethon, MD (President,
Symmetry Research; formerly Vice President, Biogen)
- Robert Dworkin, PhD (Professor,
Rochester University; Director, ACTTION
public-private partnership)
- Bryan Roth, MD, PhD (Professor,
University of North Carolina; Director,
NIMH Psychoactive Drug Screening Program)
- Maria Oquendo, MD, PhD (Chair
and Professor of Psychiatry, University of
Pennsylvania; Past President, American Psychiatric
Association)
2021 Financial Results
Cash Balance. As of December
31, 2021, MindMed had cash totaling $133.5 million compared to $80.1 million as of December 31, 2020. MindMed believes its available
cash and cash equivalents 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 $45.8 million for the year ended
December 31, 2021, compared to
$23.6 million for the same period in
2020.
Research and Development (R&D). R&D expenses
were $34.8 million for the year ended
December 31, 2021, compared to
$18.6 million for the year ended
2020. The increase was primarily due to an increase of $2.7 million in expenses related to our
MM-120 clinical research, $2.3
million in expenses related to our MM-110 clinical research,
$3.5 million in expenses related to
preclinical and other research programs, offset by a $3.5 million decrease of expense in connection
with various external R&D collaborations. Internal costs
increased $11.1 million primarily
related to an increase in non-cash expenses of $6.6 million of stock-based compensation expenses
and $2.6 million of amortization of
our developed technology.
General and Administrative (G&A).
G&A expenses were $59.1
million for the year ended December
31, 2021, compared to $14.4
million for the year ended 2020. The increase was primarily
due to an increase of $28.9 million
in non-cash stock-based compensation expenses of which $21.9 million related to the modification of
stock options and RSUs. Other contributors to the increase included
higher professional services 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
year ended December 31, 2021 was
$92.3 million, compared to
$33.7 million for the year ended
2020.
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 fiscal year 2021 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 under the headings "Risk Factors" in the Company's
filings 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.
For Media: media@mindmed.co
For Investors: ir@mindmed.co
Mind Medicine
(MindMed) Inc.
Consolidated Statements of Operations and Comprehensive
Loss
(In thousands, except share and per share
amounts)
|
|
|
|
For the Year
Ended
December 31, 2021
|
|
|
For the Year
Ended
December 31,
2020
|
|
|
For the Period
from May 30,
2019 (Date of
Incorporation)
to December 31,
2019
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Research
and development
|
|
$
|
34,789
|
|
|
$
|
18,631
|
|
|
$
|
7,549
|
|
General
and administrative
|
|
|
59,065
|
|
|
|
14,399
|
|
|
|
3,178
|
|
Total operating expenses
|
|
|
93,854
|
|
|
|
33,030
|
|
|
|
10,727
|
|
Loss from
operations
|
|
|
(93,854)
|
|
|
|
(33,030)
|
|
|
|
(10,727)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
Interest
expense, net
|
|
|
(359)
|
|
|
|
(164)
|
|
|
|
10
|
|
Foreign
exchange (loss) gain, net
|
|
|
(86)
|
|
|
|
130
|
|
|
|
18
|
|
Other
income
|
|
|
106
|
|
|
|
—
|
|
|
|
—
|
|
Loss on
revaluation of derivative liability
|
|
|
—
|
|
|
|
(873)
|
|
|
|
—
|
|
Total other expense, net
|
|
|
(339)
|
|
|
|
(907)
|
|
|
|
28
|
|
Loss before income
taxes
|
|
|
(94,193)
|
|
|
|
(33,937)
|
|
|
|
(10,699)
|
|
Income tax
benefit
|
|
|
(1,157)
|
|
|
|
—
|
|
|
|
—
|
|
Net loss
|
|
|
(93,036)
|
|
|
|
(33,937)
|
|
|
|
(10,699)
|
|
Other comprehensive
gain:
|
|
|
|
|
|
|
|
|
|
Gain on
foreign currency translation
|
|
|
762
|
|
|
|
284
|
|
|
|
—
|
|
Comprehensive
loss
|
|
$
|
(92,274)
|
|
|
$
|
(33,653)
|
|
|
$
|
(10,699)
|
|
Net loss per common
share, basic and diluted
|
|
$
|
(0.23)
|
|
|
$
|
(0.13)
|
|
|
$
|
(0.10)
|
|
Weighted-average common
shares, basic and diluted (Note 2)
|
|
|
410,656,231
|
|
|
|
266,220,592
|
|
|
|
102,763,621
|
|
Mind Medicine
(MindMed) Inc.
Consolidated Balance Sheets
(In thousands, except share amounts)
|
|
|
|
December 31,
|
|
|
2021
|
|
|
2020
|
|
|
Assets
|
|
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
|
|
Cash
|
|
$
|
133,539
|
|
|
$
|
80,094
|
|
|
Prepaid
and other current assets
|
|
|
3,676
|
|
|
|
1,425
|
|
|
Total current assets
|
|
|
137,215
|
|
|
|
81,519
|
|
|
Goodwill
|
|
|
19,918
|
|
|
|
—
|
|
|
Intangible assets,
net
|
|
|
6,869
|
|
|
|
—
|
|
|
Total assets
|
|
$
|
164,002
|
|
|
$
|
81,519
|
|
|
|
|
|
|
|
|
|
|
Liabilities and Shareholders'
Equity
|
|
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
4,178
|
|
|
$
|
2,022
|
|
|
Accrued
expenses
|
|
|
6,230
|
|
|
|
986
|
|
|
Total current liabilities
|
|
|
10,408
|
|
|
|
3,008
|
|
|
Contribution
payable
|
|
|
1,930
|
|
|
|
2,643
|
|
|
Total
liabilities
|
|
|
12,338
|
|
|
|
5,651
|
|
|
|
|
|
|
|
|
|
|
Commitments and
contingencies (Note 11)
|
|
|
|
|
|
|
|
Shareholders'
Equity:
|
|
|
|
|
|
|
|
Subordinate voting shares, no par value, unlimited authorized
as of
December 31, 2021 and 2020; 421,444,157 and
306,135,160 issued and
outstanding as of December 31, 2021 and 2020,
respectively
|
|
|
—
|
|
|
|
—
|
|
|
Multiple
voting shares, no par value, unlimited authorized as of
December 31, 2021 and 2020; 4,521 and 550,000 issued
and
outstanding as of December 31, 2021 and 2020,
respectively
|
|
|
—
|
|
|
|
—
|
|
|
Additional
paid-in capital
|
|
|
288,290
|
|
|
|
120,220
|
|
|
Accumulated other comprehensive income
|
|
|
1,046
|
|
|
|
284
|
|
|
Accumulated deficit
|
|
|
(137,672)
|
|
|
|
(44,636)
|
|
|
Total shareholders'
equity
|
|
|
151,664
|
|
|
|
75,868
|
|
|
Total liabilities and
shareholders' equity
|
|
$
|
164,002
|
|
|
$
|
81,519
|
|
|
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SOURCE Mind Medicine (MindMed) Inc.