– Topline readout of MM-120 in GAD (Phase 2b)
expected in Q4 2023 with enrollment to be concluded in Q3 2023
–
– Topline readout of MM-120 in ADHD (Phase 2a
proof-of-concept) anticipated in Q4 2023 / Q1 2024 –
– MM-402 in ASD on track for Phase 1 clinical
trial initiation in Q4 2023 –
– Entered into exclusive license agreement with
Catalent for MM-120 Zydis® orally disintegrating tablet (ODT)
formulation for advancement into pivotal clinical trials –
– Cash and cash equivalents of $116.9 million
at June 30, 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 June 30, 2023.
“We’re coming up on a critical period for MindMed as we are
close to wrapping up enrollment in our Phase 2b study of MM-120 for
the treatment of generalized anxiety disorder,” said Robert Barrow,
Chief Executive Officer and Director of MindMed. “Our ability to
enroll a study of this size in such an efficient manner stands out
in the field and speaks to the remarkable quality of our R&D
team. We are also excited to have licensed Catalent’s Zydis ODT
technology for use with MM-120 which we believe significantly
bolsters the differentiation and protectability of our MM-120
product candidate while potentially offering enhanced
bioavailability and more rapid absorption, which may lead to a
shorter treatment session. We could not be more excited about the
progress we have made to date and the numerous upcoming milestones
in the months ahead.”
Business Update
- 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 H.C.
Wainwright 25th Annual Global Investment Conference that is being
held in New York, NY from September 11-13, 2023 as well as the 2023
Cantor Global Healthcare Conference being held in New York, NY from
September 26-28, 2023.
Recent Highlights and Anticipated Upcoming
Milestones:
Phase 2b study evaluating MM-120 for generalized anxiety
disorder (GAD) remains on track for topline readout in Q4 2023.
- Patient enrollment is expected to be completed by the end of Q3
2023 with topline results for the primary endpoint expected to be
announced in Q4 2023. Based on a recent review of the Company’s
statistical assumptions, the target patient enrollment for the
trial has been lowered from 200 to 180 participants while
maintaining the statistical power (approximately 90%) to achieve
the study’s objectives.
- The primary objective of the study is to determine the
dose-response relationship of four doses of MM-120 versus placebo
as measured by the change in Hamilton Anxiety Rating Scale (HAM-A)
from baseline to week 4.
- In August 2023, MindMed announced an exclusive licensing
agreement with Catalent for its patented Zydis® ODT technology for
use with MM-120. The Company is also in the process of initiating a
Phase 1 pharmacokinetics bridging study to support advancement of
the MM-120 ODT formulation into pivotal clinical trials.
Phase 2a study evaluating MM-120 for attention deficit
hyperactivity disorder (ADHD) continues to advance toward a topline
readout in Q4 2023 / Q1 2024.
- 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 study is over 80% enrolled and on track for completion in
Q4 2023.
- The Company expects to present topline results in Q4 2023 or Q1
2024.
Advancing development of MM-402 (also referred to as R(-)-MDMA)
for autism spectrum disorder (ASD) into first clinical trial in Q4
2023.
- The Company plans to initiate its first clinical trial of
MM-402 in Q4 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 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.
- In June 2023, the Company presented 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)” at the
American Society of Clinical Psychopharmacology (ASCP) 2023 Annual
Meeting.
Collaborations and Partnerships
The Company continues to support its ongoing collaboration with
the Liechti Lab at 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.
Second Quarter 2023 Financial Results
Cash and Cash Equivalents Balance. As of June 30, 2023, MindMed
had cash and cash equivalents totaling $116.9 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 Used in Operating Activities. The net cash used in
operating activities was $27.2 million for the six months ended
June 30, 2023, compared to $28.0 million in the six months ended
June 30, 2022.
Research and Development (R&D). R&D expenses were $14.8
million for the quarter ended June 30, 2023, compared to $9.3
million for the quarter ended June 30, 2022, an increase of $5.5
million. The increase was primarily due to increases of $4.4
million in expenses related to clinical research for the MM-120 GAD
study, $0.8 million in preclinical activities, $0.6 million in
internal personnel costs as a result of increasing R&D
capacity, and $0.2 million in connection with various external
R&D collaborations, partially offset by a decrease of $0.5
million in expenses related to our MM-110 program, and a decrease
of $0.1 million related to our MM-402 program.
General and Administrative (G&A). G&A expenses were
$14.4 million for the quarter ended June 30, 2023, compared to $7.6
million for the quarter ended June 30, 2022, an increase of $6.8
million. The increase was attributable to professional services
fees and expenses related to our proxy contest in connection with
our 2023 annual general meeting of shareholders, and additional
costs to support the growth of our business.
Net Loss. Net loss for the quarter ended June 30, 2023 was $29.1
million, compared to $17.0 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 (877) 407-3982 (domestic) or
(201) 493-6780 (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, and progress of enrollment of trials and
studies; results and timing of and reporting of topline data from
clinical trials; the potential benefits of the Company’s license
with Catalent; 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 June 30, 2023 under
headings such as “Special Note Regarding Forward-Looking
Statements,” “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 June 30,
Six Months
Ended June 30,
2023
2022
2023
2022
Operating expenses:
Research and development
$
14,777
$
9,326
$
27,375
$
19,567
General and administrative
14,407
7,617
22,670
15,881
Total operating expenses
29,184
16,943
50,045
35,448
Loss from operations
(29,184
)
(16,943
)
(50,045
)
(35,448
)
Other income/(expense):
Interest income, net
1,311
82
2,595
83
Foreign exchange gain/(loss), net
247
(89
)
195
(44
)
Change in fair value of 2022 USD Financing
Warrants
(1,504
)
—
(6,690
)
—
Other income/(expense)
—
(7
)
—
1
Total other income/(expense), net
54
(14
)
(3,900
)
40
Net loss
(29,130
)
(16,957
)
(53,945
)
(35,408
)
Other comprehensive loss
Loss on foreign currency translation
(279
)
(147
)
(265
)
(196
)
Comprehensive loss
$
(29,409
)
$
(17,104
)
$
(54,210
)
$
(35,604
)
Net loss per common share, basic and
diluted
$
(0.76
)
$
(0.60
)
$
(1.41
)
$
(1.26
)
Weighted-average common shares, basic and
diluted
38,576,394
28,242,026
38,329,919
28,196,789
Mind Medicine (MindMed)
Inc.
Condensed Consolidated Balance
Sheets
(In thousands, except share
amounts)
June 30, 2023
(unaudited)
December 31,
2022
Assets
Current assets:
Cash and cash equivalents
$
116,895
$
142,142
Prepaid and other current assets
2,896
3,913
Total current assets
119,791
146,055
Goodwill
19,918
19,918
Intangible assets, net
2,108
3,689
Other non-current assets
268
331
Total assets
$
142,085
$
169,993
Liabilities and Shareholders’
Equity
Current liabilities:
Accounts payable
$
8,577
$
2,111
Accrued expenses
9,950
5,877
2022 USD Financing Warrants
16,594
9,904
Total current liabilities
35,121
17,892
Other liabilities, long-term
992
1,184
Total liabilities
36,113
19,076
Shareholders' Equity:
Common shares, no par value, unlimited
authorized as of June 30, 2023 and December 31, 2022; 38,807,159
and 37,979,136 issued and outstanding as of June 30, 2023 and
December 31, 2022, respectively
—
—
Additional paid-in capital
354,023
344,758
Accumulated other comprehensive income
362
627
Accumulated deficit
(248,413
)
(194,468
)
Total shareholders' equity
105,972
150,917
Total liabilities and shareholders'
equity
$
142,085
$
169,993
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230803968689/en/
For Media & Investor Inquiries: Maxim Jacobs, CFA
Vice President, Investor Relations and Corporate Communications
Mind Medicine (MindMed) Inc. ir@mindmed.co media@mindmed.co
Mind Medicine MindMed (NASDAQ:MNMD)
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