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United States securities and exchange commission logo
June 24, 2021
Rajiv Shukla
Chairman and Chief Executive Officer
Alpha Healthcare Acquisition Corp.
1177 Avenue of the Americas
5th Floor
New York, NY 10036
Re: Alpha Healthcare
Acquisition Corp.
Amendment No. 1 to
Registration Statement on Form S-4
Filed June 14,
20021
File No. 333-254597
Dear Mr. Shukla:
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 April
22, 2021 letter.
Amendment No. 1 to Registration Statement on Form S-1, Filed June 14,
2021
Risk Factors
Risks Related to Humacyte's Business and Industry
Risks Related to the Development and Commercialization of Our Product
Candidates
If SAEs occur or other unacceptable side effects are identified in our
HAV's we may need to
delay, abandon or limit development..., page 27
1. We note your response
to our prior comment number 7 and the revisions to page 29,
where you state that
the most frequently reported SAEs related to the HAV for
hemodialysis access
were vascular graft thrombosis, vascular graft complications, and
venous stenosis, and
the most frequently reported SAEs related to the HAV for PAD were
Rajiv Shukla
FirstName LastNameRajiv Shukla
Alpha Healthcare Acquisition Corp.
Comapany
June NameAlpha Healthcare Acquisition Corp.
24, 2021
June 24,
Page 2 2021 Page 2
FirstName LastName
vascular graft complication and graft thrombosis. Please disclose all
SAEs, rather then the
most frequently reported SAEs and disclose the number of occurrences.
Please provide
similar disclosure with respect to the SAEs experienced in your V006
trial where you
mention severe infections on page 184.
Opinion of AHAC's Financial Advisor
Certain Projected Financial Information, page 87
2. We have reviewed your revised disclosure in response to prior comment
17 and have the
following additional comments:
As previously requested, with specific reference to the
significant length of the
projections and Humacyte s current status as a clinical stage
company with limited
operations and no approved products, please expand your
disclosures to address how
management and the Board determined the reasonableness of the
projections.
Specifically, address the reliability of the projections related
to the later years
presented;
Identify the assumptions and estimates underlying the four bullet
points on page 87;
Expand your disclosures to provide additional information
surrounding the specific
assumptions and estimates underlying the forecasted information
on page 88 to
provide investors with sufficient information to evaluate the
projected financial
information and its reasonableness. For example:
o Identify the market and geographical regions for the
revenue projections and the
specific market growth rates and projected market rate
penetrations to help
provide additional insight into the range in these rates
underlying the revenue
projections. Explain how the market rate growth and market
rate penetrations
were determined. Explain the basis for assuming growth
rates over such an
extended period of time;
o Explain to us the extent you have considered providing
separate projected
financial information for each group of product candidates
based on their stage
of development given the significant differences in
probability rates;
o Explain how projected cost of goods sold were determined.
In this regard,
while you indicate they were based on current production
costs, we note that
you have not yet manufactured commercial products and the
manufacture of
your product is complex;
o Explain what you mean by product candidates projected
to be developed
during the time frame of the projections as well as other
research programs.
Are these yet to be identified projects and programs? If
so, explain in more
detail the assumptions underlying these projected costs;
and
o Please explain in more detail the specific assumptions
underlying the sales and
marketing and general and administrative expenses; and
Relabel the line item "net income" to "unlevered net income".
Disclose the amount
of interest expense excluded from such measure for each period
presented or if such
amounts cannot be estimated, explain why not.
Rajiv Shukla
Alpha Healthcare Acquisition Corp.
June 24, 2021
Page 3
Information about AHAC, page 146
3. We note your reference to backstop agreements that you may enter into
on page 153.
Please revise to state whether you have any present intent to enter
backstop agreements
and, if so, describe purpose of such agreements and likely parties if
known.
Information about Humacyte
Our Clinical and Pre-Clinical Stage Product Pipeline, page 173
4. We note your response to our prior comment number 28. Please remove
the sentence
added directly below the table comparing your product to ePTFE and
Procol on page 187
or revise it to remove the comparison given these are not head-to-head
studies.
Additionally, we note the new disclosure on pages 181-182 regarding
your V001 and
V003 trials, the disclosure on pages 183-186 regarding your V0006
trial, and the last
sentence on page 186 and related graphic on page 187 regarding your
V007 trial, in each
case, comparing either your technology or, with respect to the
disclosure on pages 183-
186, the ePTFE results in your V006 trial, to published studies.
Because such data was not
based on head to head studies, please revise your disclosure here and
comparisons
elsewhere to eliminate the comparison. You may retain any comparison
based on the
results of the head-to-head comparison conducted in your V006 trial.
Proposed Indication #2: Use of the HAV for Arteriovenous Access for
Hemodialysis, page 179
5. Please provide p-values for the results of your V006 and V004 trials,
mentioned on pages
182-186 and 189 or explain why you are unable to provide such values.
6. We note your reference on page 183 concerning the safety advantage of
the HAV over
ePTFE. Please revise this statement to remove implication that your
product candidates
are safe, including as compared to an approved device, as this
determination is solely
within the authority of the FDA and comparable regulatory bodies.
Proposed Indication #3: Peripheral Arterial Disease, page 187
7. We note your response to our prior comment number 29. Please revise
page 188 to
quantify the participant results that were excluded due to death and
clarify whether such
deaths were deemed to be related to your product candidates.
Management of the Combined Company, page 271
FirstName LastNameRajiv Shukla
8. Please provide the information required by Item 18(a)(7) of Form S-4 for
Todd Pope and a
Comapany NameAlpha
file his consent asHealthcare Acquisition
appropriate pursuant toCorp.
Rule 438 of Regulation C
under the Securities
Act.
June 24, 2021 Page 3
FirstName LastName
Rajiv Shukla
FirstName LastNameRajiv Shukla
Alpha Healthcare Acquisition Corp.
Comapany
June NameAlpha Healthcare Acquisition Corp.
24, 2021
June 24,
Page 4 2021 Page 4
FirstName LastName
Financial Statements of Humacyte, Inc.
14. Subsequent Events, page F-71
9. We have reviewed your revised disclosure in response to prior comment
36. Please
update your disclosure on page 228 to disclose the fair value of your
common stock
underlying your January 2021 stock option grants and how such fair
value was it was
determined. In addition, tell us how this fair value compares to the
Equity Value
Reference Range as determined by AHAC's Financial Advisor and address
the reasons
underlying any differences.
You may contact Michael Fay at 202-551-3812 or Jeanne Baker at
202-551-3691 if you
have questions regarding comments on the financial statements and related
matters. Please
contact Margaret Schwartz at 202-551-7153 or Suzanne Hayes at 202-551-3675 with
any other
questions.
Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Laurie A. Burlingame, Esq.