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United States securities and exchange commission logo
July 29, 2021
Suying Liu, Ph.D.
Chief Executive Officer
Mountain Crest Acquisition Corp II
311 West 43rd Street
12th Floor
New York, NY 10036
Re: Mountain Crest
Acquisition Corp II
Amendment No. 1 to
Registration Statement on Form S-4
Filed July 13, 2021
File No. 333-255493
Dear Dr. Liu:
We have reviewed your amended registration statement and have the
following
comments. In some of our comments, we may ask you to provide us with
information so we
may better understand your disclosure.
Please respond to this letter by amending your registration
statement and providing the
requested information. If you do not believe our comments apply to your
facts and
circumstances or do not believe an amendment is appropriate, please tell
us why in your
response.
After reviewing any amendment to your registration statement and
the information you
provide in response to these comments, we may have additional comments.
Unless we note
otherwise, our references to prior comments are to comments in our May
23, 2021 letter.
Amendment No. 1 to Registration Statement on Form S-4 filed July 13,
2021
Questions and Answers About the Proposals
What interests do MCAD's current officers and directors have in the
Business Combination?,
page 7
1. Please update your
disclosure here to quantify the aggregate dollar amount and describe
the nature of what the
sponsor and its affiliates have at risk that depends on completion of
a business combination.
Include the current value of securities held, loans extended, fees
due, and out-of-pocket
expenses for which the sponsor and its affiliates are awaiting
reimbursement. Provide
similar disclosure for the company s officers and directors, if
material
Suying Liu, Ph.D.
Mountain Crest Acquisition Corp II
July 29, 2021
Page 2
Better Therapeutics, Inc., page 17
2. We note your revised disclosure on page 17 in response to prior
comment number 4 and
reissue in part. Please expand your disclosure here to describe the
number and types of
sample payers that participated in your market research and describe
what you mean when
you state sample payers "responded with enthusiasm." To the extent
sample payers
responded negatively to your market research please include relevant
disclosure or
otherwise advise. In addition, we note your statement in your response
that "BTX is
focused on seeking coverage from payer groups other than Medicaid."
Please add
disclosure in your "Information About BTX" section, where appropriate,
to clarify that
your strategy seeks coverage from payer groups other than Medicaid.
Summary Historical Financial Information of MCAD, page 32
3. Please present your common stock subject to possible redemption line
item to be
consistent with your historical financial statements.
Risk Factors, page 37
4. Please add a risk factor to disclose the material risks to
unaffiliated investors presented by
taking the company public through a merger rather than an underwritten
offering. These
risks could include the absence of due diligence conducted by an
underwriter that would
be subject to liability for any material misstatements or omissions in
a registration
statement.
Notes to Unaudited Pro Forma Condensed Combined Financial Information
Adjustments to Unaudited Pro Forma Condensed Combined Statements of Operation,
page 97
5. Here under item (BB), you stated that you reversed $189k
market-to-market impact of the
change in fair value of the SAFEs for the year ended December 31,
2020. However, you
also added back $3,042k increase in fair value of SAFEs outstanding as
of March 31,
2021, through the close of the Business Combination. Because you are
giving effect to the
transactions as if they occurred on January 1, 2020, it is unclear why
you would not adjust
to remove all fair value changes of the SAFEs that will be converted,
similar to your pro
forma adjustment for the three months ended March 31, 2021.
Pivotal study of BT-001, page 157
6. We note your response to prior comment number 24 and revised risk factor
disclosure on
page 53 and reissue in part. Please add similar disclosure describing
the virtual aspects of
FirstName LastNameSuying Liu, Ph.D.
your trial to your description of your pivotal study of BT-001 section
on page 157. In
Comapany NameMountain
addition, Crest
please update Acquisition
your heading toCorp II that you study of
BT-001 is "potentially"
qualify
July 29,pivotal and make
2021 Page 2 similar updates throughout the registration
statement, as applicable.
FirstName LastName
Suying Liu, Ph.D.
FirstName LastNameSuying Liu, Ph.D.
Mountain Crest Acquisition Corp II
Comapany
July NameMountain Crest Acquisition Corp II
29, 2021
July 29,
Page 3 2021 Page 3
FirstName LastName
BTX's Solution, page 158
7. We note your response to comment 17 and the revised disclosure on
pages 164-165 and
reissue in part. We continue to note your conclusory statement
regarding the safety or
efficacy of your product candidates when you state, [BT-001 s]
strong efficacy signal.
Since findings of safety and efficacy are solely within the authority
of the FDA and are
assessed throughout all clinical trial phases, please revise to remove
any statements that
suggest the efficacy of your product candidates. In addition, we note
your disclosure
that BTX demonstrated comparable efficacy in lowering A1c to orally
administered
medications with fewer side effects. However, we note your
completed pilot study
enrolled patients who "were taking 2.2 antihyperglycemic medications."
Please provide
your basis for your claim that BTX demonstrated comparable efficacy in
lowering A1c to
orally administered medications given that it does not appear that you
have performed a
head-to-head study and it also appears that participants in your pilot
study continued taking antihyperglycemic medications or otherwise
advise.
BTX's Platform, page 160
8. We note your response to prior comment number 20 and revised
disclosure on pages 161-
162. Given that you currently do not have any FDA approved products,
please revise your
claim that, "BTX s platform supports the rapid discovery and
validation of PDTs that treat
CMDx using nCBT to address root causes."
Changes in FBG Observed in a Pilot Study of BT-001, page 165
9. We note you response to prior comment 22 and reissue in part. Please
delete footnote 1 in
your graphic on page 165 or revise to clarify what you mean when you
say, "[t]he FDA
approvable endpoint is a reduction in A1c of -0.4% compared to
control." We further
note, that the graphic depicts the results of your pilot study, which
does not appear to have
a control group.
Early feasibility study, page 167
10. We note you response to prior comment 22, including your inclusion of
additional
disclosure of certain p values with respect to BT-001. Please revise
your disclosure here to
disclose the p values and indicate whether each reported study result
for your other
product candidates were statistically significant.
Use of Proceeds, page 187
11. We note your response to prior comment number 16 and revised
disclosure on page
187. Please revise to provide more specific disclosure of the intended
use of proceeds, as
well as the approximate amounts intended to be used for each such
purpose. In this regard,
consider disclosing the amount of proceeds that you plan to use for
the continued
development of BT-001, including your ongoing potentially pivotal
trial for BT-001.
Suying Liu, Ph.D.
Mountain Crest Acquisition Corp II
July 29, 2021
Page 4
Employment Agreements and Offer Letters
Kevin Applebaum, page 193
12. We note your response to prior comment 26 and reissue in part. Please add
narrative disclosure describing and quantifying Mr. Applebaum's annual
base salary,
target bonus and transaction bonus.
Director Compensation, page 201
13. We note that prior to the Business Combination you intend to enter into
an executive
chairperson agreement with Mr. Perry. Please file this agreement as an
exhibit to the
registration statement. See Item 601(b)(10) of Regulation S-K.
General
14. We note that you deleted your prior disclosure that "BTX has entered into
a research
collaboration with Steward Health Care Network ( Steward ) to conduct
a one-year real
world use study of BT-001 in up to 1,000 patients" which was expected to
begin
enrollment "by mid 2021." Please advise if the research collaboration
agreement was
terminated. To the extent the research collaboration agreement was
terminated, please
update your disclosure to provide an explanation for the termination.
You may contact Li Xiao at (202) 551-4391 or Daniel Gordon at (202)
551-3486 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Jason Drory at (202) 551-8342 or Joe McCann at (202) 551-6262 with any
other
questions.
Sincerely,
FirstName LastNameSuying Liu, Ph.D.
Division of
Corporation Finance
Comapany NameMountain Crest Acquisition Corp II
Office of Life
Sciences
July 29, 2021 Page 4
cc: Andrei Sirabionian, Esq.
FirstName LastName