– Key MM-120 readouts in GAD (Phase 2b) and
ADHD (Phase 2a) expected by end of 2023 –
– MM-402 pre-clinical data in ASD model to be
presented at ASCP 2023 Annual Meeting –
– Strengthened leadership team with appointment
of Mark R. Sullivan as Chief Legal Officer –
– Cash and cash equivalents of $129.4 million
at March 31, 2023 –
– Company to host conference call today at 4:30
PM ET –
Mind Medicine (MindMed) Inc. (NASDAQ: MNMD), (NEO: MMED),
(the “Company” or "MindMed"), a clinical stage biopharmaceutical
company developing novel product candidates to treat brain health
disorders, today reported its financial results for the quarter
ended March 31, 2023.
“2023 is a critical year for MindMed and we are well positioned
to continue advancing our R&D pipeline toward multiple
near-term milestones later this year," said Robert Barrow, Chief
Executive Officer and Director of MindMed. "These include key data
from our Phase 2b study of MM-120 for the treatment of generalized
anxiety disorder, as well as from our Phase 2a proof-of-concept
trial of repeated low-dose MM-120 in
attention-deficit/hyperactivity disorder. Additionally, we plan to
initiate the first clinical trial of MM-402 later in the year
following positive preclinical results, which we plan to present at
the ASCP 2023 Annual Meeting. We made great progress throughout the
first quarter and continue to remain focused on long-term value
creation for our shareholders through focused and efficient
execution."
Business Update
- In April 2023, Mark R. Sullivan was appointed as Chief Legal
Officer. Mr. Sullivan comes to MindMed with extensive and
demonstrated success as a pharmaceutical executive, with particular
expertise in the areas of SEC reporting, financing, corporate
governance and compliance, mergers and acquisitions, intellectual
property, litigation management and business development.
- The Company reiterates its guidance for its cash runway, which
is expected to fund its current operating plan into the first half
of 2025.
- MindMed’s management team will participate in the RBC Capital
Markets Global Healthcare Conference that is being held in New
York, NY from May 16-17, 2023, the BIO International Convention
being held in Boston, MA from June 5-8, 2023, the Jefferies Global
Healthcare Conference that is being held in New York, NY from June
7-9, 2023 as well as the H.C. Wainwright Neuropsychiatry Conference
that is being held virtually on June 26, 2023.
- The Company plans to host an analyst and investor day in the
second quarter of 2023. The event will be hosted by the Company’s
management team and will include a physician expert and other key
opinion leaders.
Recent Highlights and Anticipated
Upcoming Milestones:
Phase 2b study evaluating MM-120 for generalized anxiety
disorder ("GAD") remains on track for late 2023 topline
readout
- MM-120, the Company’s proprietary, pharmaceutically optimized
form of lysergide D-tartrate, is being developed for the treatment
of GAD.
- In August 2022, the Company initiated dosing in the 200-patient
Phase 2b dose-optimization study of MM-120 for the treatment of
GAD.
- Patient enrollment is currently ongoing, and the study remains
on track, with topline results expected to be announced in late
2023.
Phase 2a study evaluating MM-120 for attention deficit
hyperactivity disorder ("ADHD") remains on track for late 2023
topline readout
- The Company’s Phase 2a proof-of-concept trial for the treatment
of ADHD is designed to assess the safety and efficacy of repeated
low-dose MM-120 administration in 52 patients.
- The Company expects topline results in late 2023.
Advancing development of MM-402 into first clinical trial in
2023
- The Company is developing MM-402, the Company's proprietary
form of the R-enantiomer of 3,4-Methylenedioxymethamphetamine
("MDMA"), for the treatment of core symptoms of autism spectrum
disorder ("ASD").
- A late breaking abstract on the results from a pre-clinical
study of MM-402 in a model of ASD, titled “MM-402,
R(−)-3,4-Methylenedioxymethamphetamine, Demonstrates Prosocial and
Therapeutic-Like Effects in Fmr1 Knockout mice, a Preclinical Model
of Autism Spectrum Disorder (due to Fragile X syndrome)” has been
accepted for presentation at the American Society of Clinical
Psychopharmacology (ASCP) 2023 Annual Meeting that is being held in
Miami Beach, FL from May 30-June 2, 2023.
- The Company plans to initiate its first clinical trial of
MM-402 in 2023. This Phase 1 study is intended to characterize the
tolerability, pharmacokinetics and pharmacodynamics of MM-402, and
to evaluate early signals of efficacy to support the Company’s
approach in targeting core symptoms of ASD.
- University Hospital Basel ("UHB") in Switzerland, the Company’s
collaborator, is currently enrolling participants in a Phase 1
investigator-initiated trial of R(-)-MDMA, S(+)-MDMA and R/S-MDMA
in healthy volunteers. This trial compares the tolerability,
pharmacokinetics and acute subjective, physiological and endocrine
effects of the three molecules.
Collaborations and
Partnerships
The Company continues to support its ongoing collaboration with
the Liechti Lab at University Hospital Basel (“UHB”) in
Switzerland. MindMed has exclusive worldwide rights to data,
compounds and patent rights associated with UHB’s research on
lysergide and other psychedelic compounds, including data from
preclinical studies and investigator-initiated clinical trials.
In April 2023, Prof. Matthias Liechti and Dr. Felix Mueller,
MindMed collaborators at UHB, released positive topline data from a
Phase 2 double-blind investigator-initiated clinical trial
evaluating two lysergide regimens in the treatment of major
depressive disorder (MDD). These demonstrated the significant,
rapid and beneficial effects of lysergide and its potential to
safely mitigate symptoms of MDD. Patients in the high dose arm
(n=28) demonstrated a least square mean change from baseline in
clinician-rated Inventory of Depressive Symptomatology (IDS-C)
scores of -12.9 points compared to -3.6 points in the lower dose
arm (n=27, p=0.02). The statistically significant benefit as
measured by IDS-C was maintained up to 16 weeks after the first
administration compared to placebo (p=0.008). Data from the
secondary endpoints were also encouraging. The investigational drug
was generally well-tolerated, as indicated by reported adverse
events, changes in vital signs and laboratory values.
First Quarter 2023 Financial Results
Cash Balance. As of March 31, 2023, MindMed had cash and cash
equivalents totaling $129.4 million compared to $142.1 million as
of December 31, 2022. The Company believes its available cash and
cash equivalents will be sufficient to fund its operating
requirements into the first half of 2025.
Net Cash in Operating Activities. The net cash used in operating
activities was $13.3 million for the quarter ended March 31, 2023,
compared to $12.9 million in the quarter ended March 31, 2022.
Research and Development (R&D). R&D expenses were $12.6
million for the quarter ended March 31, 2023, compared to $10.2
million for the quarter ended March 31, 2022, an increase of $2.4
million. The increase was primarily due to increases of $2.9
million in expenses related to clinical research for the MM-120 GAD
study, $0.9 million in expenses related to our MM-402 program, and
$0.2 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 MM-110 program, and a decrease
of $0.9 million of expenses in connection with various external
R&D collaborations.
General and Administrative (G&A). G&A expenses were $8.3
million for the quarter ended March 31, 2023, compared to $8.3
million for the quarter ended March 31, 2022.
Net Loss. Net loss for the quarter ended March 31, 2023 was
$24.8 million, compared to $18.5 million for the same period in
2022.
Conference Call and Webcast Reminder
MindMed management will host a conference call at 4:30 PM EST
today to provide a corporate update and review the Company’s first
quarter 2023 financial results. Individuals may participate in the
live call via telephone by dialing (888) 396-8049 (domestic) or
(416) 764-8646 (international). The webcast can be accessed live
here on the Financials page in the Investors section of the MindMed
website, https://mindmed.co/. 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 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 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
includes, but is not limited to, statements regarding anticipated
upcoming milestones, trials and studies, results and timing of
clinical trials, the potential benefits of the Company’s product
candidates, and the Company’s cash runway funding its operations
into the first half of 2025. 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
fiscal year ended December 31, 2022, the Company’s Quarterly Report
on Form 10-Q for the fiscal quarter ended March 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.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.
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,
2023
2022
Operating expenses:
Research and development
$
12,599
$
10,241
General and administrative
8,263
8,264
Total operating expenses
20,862
18,505
Loss from operations
(20,862
)
(18,505
)
Other income/(expense):
Interest income/(expense), net
1,284
(27
)
Foreign exchange gain/(loss), net
(52
)
45
Change in fair value of 2022 USD Financing
Warrants
(5,185
)
—
Other income
—
36
Total other income/(expense), net
(3,953
)
54
Net loss
(24,815
)
(18,451
)
Other comprehensive loss
Gain/(loss) on foreign currency
translation
14
(49
)
Comprehensive loss
$
(24,801
)
$
(18,500
)
Net loss per common share, basic and
diluted
$
(0.65
)
$
(0.66
)
Weighted-average common shares, basic and
diluted
38,077,251
28,147,499
Mind Medicine (MindMed)
Inc.
Condensed Consolidated Balance
Sheets
(In thousands, except share
amounts)
March 31, 2023
(unaudited)
December 31, 2022
Assets
Current assets:
Cash and cash equivalents
$
129,409
$
142,142
Prepaid and other current assets
3,004
3,913
Total current assets
132,413
146,055
Goodwill
19,918
19,918
Intangible assets, net
2,898
3,689
Other non-current assets
300
331
Total assets
$
155,529
$
169,993
Liabilities and Shareholders’
Equity
Current liabilities:
Accounts payable
$
2,320
$
2,111
Accrued expenses
6,687
5,877
2022 USD Financing Warrants
15,089
9,904
Total current liabilities
24,096
17,892
Other liabilities, long-term
1,089
1,184
Total liabilities
25,185
19,076
Commitments and contingencies
Shareholders' Equity:
Common shares, no par value, unlimited
authorized as of March 31, 2023 and December 31, 2022; 38,290,111
and 37,979,136 issued and outstanding as of March 31, 2023 and
December 31, 2022, respectively
—
—
Additional paid-in capital
348,986
344,758
Accumulated other comprehensive income
641
627
Accumulated deficit
(219,283
)
(194,468
)
Total shareholders' equity
130,344
150,917
Total liabilities and shareholders'
equity
$
155,529
$
169,993
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230504005909/en/
For Media & Investor Inquiries, please contact:
Maxim Jacobs, CFA Vice President, Investor Relations and
Corporate Communications Mind Medicine (MindMed) Inc. ir@mindmed.co
media@mindmed.co
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