Pivotal trial of BT-001 in type 2 diabetes
expected to be fully enrolled in Q4 2021, with primary endpoint
readout in Q1 2022; de novo submission to FDA requesting marketing
authorization planned following completion of trial
Clinical development of BT-002 and BT-003
in hypertension and hyperlipidemia on track; pivotal studies
expected to commence in 2022
Early clinical discovery in non-alcoholic fatty
liver disease (NAFLD) expected to enroll first patient in Q1
2022
Real-world evidence study evaluating the
long-term effectiveness and healthcare cost impact of BT-001 to
enroll first patient in Q4 2021; two study partners (Colorado
Prevention Center and Catalyst Health Network) announced and one
more anticipated
New patent filing covering inventions in
nutritional cognitive behavior therapy and the use of AI to guide
treatment expands intellectual property portfolio
Up to $150M in cash from financing activities
including merger with Mountain Crest Acquisition Corp II, a special
purpose acquisition company or “SPAC”; a fully committed $50M PIPE;
and a $50M debt facility provide an operating runway into 2023
Better Therapeutics, Inc. (“Better
Therapeutics”), a prescription digital therapeutics (PDT) company
developing cognitive behavioral therapy to address root causes of
cardiometabolic diseases, today provided an update on recent
progress since announcing its intention to merge with Mountain
Crest Acquisition Corp. II (NASDAQ: MCAD) (“Mountain Crest II”).
The merger and concurrent PIPE and debt financings are expected to
close in October.
“I’m pleased with the progress we’ve
made since announcing our plans to become a public company through
a merger with Mountain Crest II,” said Kevin Appelbaum, co-founder
and chief executive officer of Better Therapeutics. “We’ve advanced
our clinical pipeline in type 2 diabetes, hypertension,
hyperlipidemia and non-alcoholic fatty liver disease (NAFLD). Our
potentially pivotal study of BT-001, a PDT for the treatment of
type 2 diabetes, is approaching full enrollment, and a real-world
evidence study of BT-001 is about to begin enrolling. We expect the
data generated from the pivotal study will form the basis of our
planned de novo submission to FDA requesting marketing
authorization of BT-001, and data from the real-world evidence
study, if positive, will provide compelling evidence of clinical
and economic impact to support reimbursement coverage. We’ve added
a fourth patent family to our intellectual property portfolio, and,
through the SPAC, PIPE and debt financings, we will be well funded
into 2023, as we progress towards the commercial launch of our
first PDT in diabetes and advance our pipeline across multiple
cardiometabolic diseases.”
The Better Therapeutics platform
blends clinical, behavioral and psychological inputs into a series
of cognitive behavioral therapy lessons and skill-building modules
designed to shift neural pathways of the brain and treat the
disease at its source through behavior change. Following FDA
marketing authorization or clearance, it is anticipated that
primary care providers will prescribe, and insurers will reimburse,
Better Therapeutics’ PDTs much like they would a traditional
medication.
About Better Therapeutics
Better Therapeutics is a
prescription digital therapeutics (PDT) company developing a novel
form of cognitive behavioral therapy to address root causes of
cardiometabolic diseases. The company has developed a proprietary
platform for the development of FDA-regulated, software-based
solutions for type 2 diabetes, heart disease and other conditions.
The cognitive behavioral therapy delivered by Better Therapeutics’
PDTs is designed to enable changes in neural pathways of the brain
so lasting changes in behavior become possible. Addressing the
underlying causes of these diseases has the potential to
dramatically improve patient health while lowering healthcare
costs. Better Therapeutics’ PDTs are intended to be prescribed by
physicians and reimbursed like traditional medicines. For more
information, visit: bettertx.com.
About Mountain Crest Acquisition
Corp. II
Mountain Crest Acquisition Corp. II
is a blank check company formed for the purpose of effecting a
merger, share exchange, asset acquisition, share purchase,
reorganization or similar business combination with one or more
businesses. Mountain Crest II’s efforts to identify a prospective
target business will not be limited to a particular industry or
geographic region, although the company intends to focus on
operating businesses in North America.
Additional Information
On April 6, 2021, Better
Therapeutics entered into a definitive merger agreement with
Mountain Crest II , a special purpose acquisition company for a
proposed business combination.
In connection with the proposed
business combination between Mountain Crest II and Better
Therapeutics, Mountain Crest II has filed a registration statement
on Form S-4 containing a proxy statement/prospectus (the “Form
S-4”) with the Securities and Exchange Commission (the “SEC”). The
Form S-4 includes a proxy statement to be distributed to holders of
Mountain Crest II’s common stock in connection with Mountain Crest
II’s solicitation of proxies for the vote by Mountain Crest II’s
shareholders with respect to the proposed transaction and other
matters as described in the Form S-4, as well as the prospectus
relating to the offer of securities to be issued to Better
Therapeutics’ stockholders in connection with the proposed business
combination. After the Form S-4 has been declared effective,
Mountain Crest II will mail a definitive proxy statement, when
available, to its stockholders. Investors and security holders and
other interested parties are urged to read the Form S-4, any
amendments thereto and any other documents filed with the SEC
carefully and in their entirety when they become available because
they will contain important information about Mountain Crest II,
Better Therapeutics, and the proposed business combination.
Additionally, Mountain Crest II will file other relevant materials
with the SEC in connection with the business combination. Copies of
these documents may be obtained free of charge at the SEC’s web
site at www.sec.gov. Securityholders of Mountain Crest II are urged
to read the Form S-4 and the other relevant materials when they
become available before making any voting decision with respect to
the proposed business combination because they will contain
important information.
Participants in the
Solicitation
Mountain Crest II and its directors
and executive officers may be deemed participants in the
solicitation of proxies with respect to the proposed business
combination under the rules of the SEC. Securityholders may obtain
more detailed information regarding the names, affiliations, and
interests of certain of Mountain Crest II’s executive officers and
directors in the solicitation by reading Mountain Crest II’s Form
S-4 and other relevant materials filed with the SEC in connection
with the proposed business combination. Information about Mountain
Crest II’s directors and executive officers and their ownership of
Mountain Crest II common stock is set forth in Mountain Crest II’s
annual report on Form 10-K for the year ended December 31, 2020,
dated March 30, 2021, as modified or supplemented by any Form 3 or
Form 4 filed with the SEC since the date of that filing. Other
information regarding the interests of Mountain Crest II’s
participants in the proxy solicitation, which in some cases, may be
different than those of their stockholders generally, are set forth
in the Form S-4 relating to the proposed business combination.
These documents can be obtained free of charge at the SEC's web
site at www.sec.gov.
Better Therapeutics and its
directors and executive officers may also be deemed to be
participants in the solicitation of proxies from the stockholders
of Mountain Crest II in connection with the proposed business
combination. A list of the names of such directors and executive
officers and information regarding their interests in the proposed
business combination are included in the Form S-4 for the proposed
business combination.
Non-Solicitation
This press release shall not
constitute a solicitation of a proxy, consent, or authorization
with respect to any securities or in respect of the proposed
business combination. This press release shall also not constitute
an offer to sell or the solicitation of an offer to buy any
securities, nor shall there be any sale of securities in any states
or jurisdictions in which such offer, solicitation, or sale would
be unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No offering of securities
shall be made except by means of a prospectus meeting the
requirements of Section 10 of the Securities Act of 1933, as
amended, or an exemption therefrom.
Forward-Looking
Statements
This press release contains
“forward-looking statements” within the meaning of the United
States Private Securities Litigation Reform Act of 1995. These
forward-looking statements include, but are not limited to,
statements regarding the delivery of cognitive behavioral therapy
and/ or prescription digital therapeutics or PDTs, by Better
Therapeutics to address the root causes of type 2 diabetes and
other cardiometabolic diseases; development of a proprietary
platform and software-based solutions for treatment of type 2
diabetes, heart disease and other conditions; achievement of
changes in neural pathways of the brain and lasting changes in
behavior through cognitive behavioral therapy delivered by Better
Therapeutics’ PDT; the capability of Better Therapeutics to address
the underlying causes of certain diseases and its related potential
to improve patient health while lowering healthcare costs; the
potential for Better Therapeutics’ clinically validated mobile
applications to be prescribed by physicians and reimbursed like
traditional medicines; potential and significance of the results of
the potentially pivotal study of BT-001 or any clinical or other
trial or any expectations regarding the potentially pivotal trial
of BT-001 to be fully enrolled in Q4 2021 with primary endpoint
readout in Q1 2022; the potential success of BT-001 as a prescribed
treatment used under physician supervision for people with
uncontrolled type 2 diabetes; the possibility for the results of
the potentially pivotal study to support a regulatory submission
for marketing authorization from the FDA; the potential timing of
Better Therapeutics’ expected progress towards developing and
obtaining FDA approval for its products, including statements
regarding the de novo submission to the FDA requesting marketing
authorization following completion of any trial, pending positive
outcomes, related research and validation studies; the clinical
development of BT-002 and BT-003 in hypertension and hyperlipidemia
and the potential timing of such development; the commencement of
other pivotal studies and expected timing for the same; early
clinical discovery in non-alcoholic fatty liver disease (NAFLD) and
any expected timing of studies or trials for the same; the expected
timing or start of any real-world evidence studies evaluating the
long-term effectiveness and healthcare cost impact of BT-001; the
potential impact of any studies announced with any study partners
announced; the impact of any new patent filing or addition to
intellectual property portfolio of Better Therapeutics; the future
financial stability, strength or success of Better Therapeutics;
the successful or positive impact that any financing transaction
may have on Better Therapeutics’ business, including advancing
Better Therapeutics’ pipeline of additional PDTs for other
behavior-driven cardiometabolic diseases; statements as to the
expected timing, completion and effects of the merger, any
financing or debt transaction. In addition, any statements that
refer to projections (including EBITDA, adjusted EBITDA, EBITDA
margin and revenue projections), forecasts or other
characterizations of future events or circumstances, including any
underlying assumptions, are forward-looking statements.
Forward-looking statements are typically identified by words such
as “plan,” “believe,” “expect,” “anticipate,” “intend,” “outlook,”
“estimate,” “forecast,” “project,” “continue,” “could,” “may,”
“might,” “possible,” “potential,” “predict,” “should,” “would” and
other similar words and expressions, but the absence of these words
does not mean that a statement is not forward-looking. Any
forward-looking statements in this press release are based on
management’s current expectations of future events and are subject
to a number of risks and uncertainties that could cause actual
results to differ materially and adversely from those set forth in
or implied by such forward-looking statements. These risks and
uncertainties include, but are not limited to, the risk that the
FDA may not be satisfied with the design of any of Better
Therapeutics’ studies and trials, and payers may not reimburse
BT-001, if approved, the risk that the results of previously
conducted studies will not be repeated or observed in ongoing or
future studies involving our product candidates, the risk that the
current COVID-19 pandemic will impact Better Therapeutics’ platform
validation, product testing, the timing of the Better Therapeutics’
submission of the BT-001 for marketing approval from the FDA and
other operations, and the risk that the Merger, any financing or
debt transaction may not be completed in a timely manner or at all.
For a discussion of other risks and uncertainties, and other
important factors, any of which could cause Better Therapeutics’
actual results to differ from those contained in the
forward-looking statements, see the section entitled “Risk
Factors'' in Mountain Crest II’s filings on file with the
Securities and Exchange Commission, available at the Securities and
Exchange Commission’s website at www.sec.gov, and as well as
discussions of potential risks, uncertainties and other important
factors in Mountain Crest II and/or Better Therapeutics’
subsequent/future filings, if any, with the Securities and Exchange
Commission. All information in this press release is as of the date
of the release, and the Company undertakes no duty to update this
information unless required by law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210909005295/en/
Better Therapeutics Media Contact Heidi Chokeir, Ph.D.
heidi.chokeir@canalecomm.com +1 619 203 5391
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