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Cadrenal Therapeutics, Inc.
Response Received
1 company response(s)
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Cadrenal Therapeutics, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2024-11-20
Cadrenal Therapeutics, Inc.
Summary
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Company responded
2024-11-21
Cadrenal Therapeutics, Inc.
Summary
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Cadrenal Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
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Cadrenal Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
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Cadrenal Therapeutics, Inc.
Response Received
4 company response(s)
High - file number match
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Company responded
2022-10-17
Cadrenal Therapeutics, Inc.
References: October 13, 2022
↓
Company responded
2022-12-08
Cadrenal Therapeutics, Inc.
References: December 8, 2022
↓
Company responded
2023-01-17
Cadrenal Therapeutics, Inc.
Summary
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Company responded
2023-01-17
Cadrenal Therapeutics, Inc.
Summary
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Cadrenal Therapeutics, Inc.
Awaiting Response
0 company response(s)
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SEC wrote to company
2022-12-08
Cadrenal Therapeutics, Inc.
Summary
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Cadrenal Therapeutics, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2022-08-30
Cadrenal Therapeutics, Inc.
Summary
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Cadrenal Therapeutics, Inc.
Awaiting Response
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SEC wrote to company
2022-08-11
Cadrenal Therapeutics, Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-27 | Company Response | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2026-04-27 | SEC Comment Letter | Cadrenal Therapeutics, Inc. | DE | 333-295200 | Read Filing View |
| 2024-11-21 | Company Response | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-11-20 | SEC Comment Letter | Cadrenal Therapeutics, Inc. | DE | 333-283226 | Read Filing View |
| 2024-03-18 | Company Response | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-03-15 | SEC Comment Letter | Cadrenal Therapeutics, Inc. | DE | 333-277835 | Read Filing View |
| 2023-07-26 | SEC Comment Letter | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-07-26 | Company Response | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-01-17 | Company Response | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-01-17 | Company Response | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-12-08 | Company Response | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-12-08 | SEC Comment Letter | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-10-17 | Company Response | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-10-13 | SEC Comment Letter | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-09-22 | Company Response | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-08-30 | SEC Comment Letter | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-08-11 | SEC Comment Letter | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-27 | SEC Comment Letter | Cadrenal Therapeutics, Inc. | DE | 333-295200 | Read Filing View |
| 2024-11-20 | SEC Comment Letter | Cadrenal Therapeutics, Inc. | DE | 333-283226 | Read Filing View |
| 2024-03-15 | SEC Comment Letter | Cadrenal Therapeutics, Inc. | DE | 333-277835 | Read Filing View |
| 2023-07-26 | SEC Comment Letter | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-12-08 | SEC Comment Letter | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-10-13 | SEC Comment Letter | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-08-30 | SEC Comment Letter | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-08-11 | SEC Comment Letter | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-04-27 | Company Response | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-11-21 | Company Response | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-03-18 | Company Response | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-07-26 | Company Response | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-01-17 | Company Response | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-01-17 | Company Response | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-12-08 | Company Response | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-10-17 | Company Response | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-09-22 | Company Response | Cadrenal Therapeutics, Inc. | DE | N/A | Read Filing View |
2026-04-27 - CORRESP - Cadrenal Therapeutics, Inc.
CORRESP
1
filename1.htm
April 27, 2026
VIA EDGAR
United States Securities
and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Alan Campbell
Re:
Cadrenal Therapeutics, Inc.
Registration Statement on Form S-1
Filed April 21, 2026
File No: 333-295200
Dear Mr. Campbell:
Cadrenal Therapeutics, Inc.
(the “Registrant”) hereby requests that the effective date of the above-referenced Registration Statement on Form S-3
(File No. 333-295200), be accelerated by the U.S. Securities and Exchange Commission (the “Commission”) to become effective
on Wednesday, April 29, 2026, at 5:00 p.m., Eastern Time, or as soon as reasonably practicable thereafter.
The Registrant understands
that the Staff of the Commission will consider this request as confirmation by the Registrant that it is aware of its responsibilities
under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement.
The Registrant hereby authorizes
Leslie Marlow and/or Jamie Plisner of Blank Rome LLP to orally modify or withdraw this request for acceleration. Please contact Ms. Marlow
at (212) 885-5358 or Ms. Plisner at (212) 885-5298 with any questions you may have concerning this request, and please notify either of
them when this request for acceleration has been granted.
Thank you.
Very truly yours,
CADRENAL THERAPEUTICS, INC.
By:
/s/ Quang Pham
Name:
Quang Pham
Title:
Chief Executive Officer
cc: Leslie Marlow, Blank Rome LLP
Jamie Plisner, Blank Rome LLP
2026-04-27 - UPLOAD - Cadrenal Therapeutics, Inc. File: 333-295200
April 27, 2026
Quang Pham
Chairman and Chief Executive Officer
Cadrenal Therapeutics, Inc.
822 A1A North, Suite 306
Ponte Vedra, FL 32082
Re: Cadrenal Therapeutics, Inc.
Registration Statement on Form S-3
Filed April 21, 2026
File No. 333-295200
Dear Quang Pham:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Alan Campbell at 202-551-4224 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Leslie Marlow, Esq.
2024-03-18 - CORRESP - Cadrenal Therapeutics, Inc.
CORRESP
1
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March 18, 2023
VIA EDGAR
United States Securities
and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Cadrenal Therapeutics, Inc.
Registration Statement on Form S-3
Filed March 12, 2024
File No: 333-277835
Dear Sir or Madam:
Cadrenal Therapeutics, Inc. (the
“Registrant”) hereby requests that the effective date of the above-referenced Registration Statement on Form S-3, as
amended (File No. 333-277835), be accelerated by the U.S. Securities and Exchange Commission (the “Commission”) to
become effective on Wednesday, March 20, 2024, at 5:00 p.m., Eastern Time, or as soon as reasonably practicable thereafter.
The Registrant understands
that the Staff of the Commission will consider this request as confirmation by the Registrant that it is aware of its responsibilities
under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement.
The Registrant hereby authorizes
Leslie Marlow and/or Jamie Plisner of Blank Rome LLP to orally modify or withdraw this request for acceleration. Please contact Ms. Marlow
at (212) 885-5358 or Ms. Plisner at (212) 885-5298 with any questions you may have concerning this request, and please notify either of
them when this request for acceleration has been granted.
Thank you.
Very truly yours,
CADRENAL THERAPEUTICS, INC.
By:
/s/ Quang Pham
Name:
Quang Pham
Title:
Chief Executive Officer
cc: Leslie Marlow, Blank Rome LLP
Jamie Plisner, Blank Rome LLP
2024-03-15 - UPLOAD - Cadrenal Therapeutics, Inc. File: 333-277835
United States securities and exchange commission logo
March 15, 2024
Quang Pham
President, Chief Executive Officer and Director
Cadrenal Therapeutics, Inc.
822 A1A North, Suite 306
Ponte Vedra, Florida 32082
Re:Cadrenal Therapeutics, Inc.
Registration Statement on Form S-3
Filed March 12, 2024
File No. 333-277835
Dear Quang Pham:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Chris Edwards at 202-551-6761 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Leslie Marlow, Esq.
2023-07-26 - UPLOAD - Cadrenal Therapeutics, Inc.
United States securities and exchange commission logo
July 26, 2023
Quang Pham
President, Chief Executive Officer and Director
Cadrenal Therapeutics, Inc.
822 A1A North, Suite 306
Ponte Vedra, Florida 32082
Re:Cadrenal Therapeutics, Inc.
Registration Statement on Form S-1
Filed July 24, 2023
File No. 333-273384
Dear Quang Pham:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Daniel Crawford at 202-551-7767 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Leslie Marlow, Esq.
2023-07-26 - CORRESP - Cadrenal Therapeutics, Inc.
CORRESP
1
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July 26, 2023
VIA EDGAR
United States Securities
and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re:
Cadrenal Therapeutics, Inc.
Registration Statement on Form S-1
Filed July 24, 2023
File No: 333-273384
Dear Sir or Madam:
Cadrenal Therapeutics, Inc. (the
“Registrant”) hereby requests that the effective date of the above-referenced Registration Statement on Form S-1, as
amended (File No. 333-273384), be accelerated by the U.S. Securities and Exchange Commission (the “Commission”) to
become effective on Friday, July 28, 2023, at 5:00 p.m., Eastern Time, or as soon as reasonably practicable thereafter.
The Registrant understands
that the Staff of the Commission will consider this request as confirmation by the Registrant that it is aware of its responsibilities
under the federal securities laws as they relate to the issuance of the securities covered by the Registration Statement.
The Registrant hereby authorizes
Leslie Marlow and/or Jamie Plisner of Blank Rome LLP to orally modify or withdraw this request for acceleration. Please contact Ms. Marlow
at (516) 457-4238, or Ms. Plisner at (212) 885-5298 with any questions you may have concerning this request, and please notify either
of them when this request for acceleration has been granted.
Very truly yours,
CADRENAL THERAPEUTICS, INC.
By:
/s/ Quang Pham
Name:
Quang Pham
Title:
Chief Executive Officer
cc: Leslie Marlow, Blank Rome LLP
Jamie Plisner, Blank Rome LLP
2023-01-17 - CORRESP - Cadrenal Therapeutics, Inc.
CORRESP
1
filename1.htm
January 17, 2023
VIA EDGAR
United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Dillon Hagius
Re:
Cadrenal Therapeutics, Inc.
Registration Statement on Form S-1, as amended
File No: 333-267562
Request for Acceleration
Ladies and Gentlemen:
Pursuant
to Rule 461 under the Securities Act of 1933, as amended, Cadrenal Therapeutics, Inc. (the “Registrant”)
hereby requests that the United States Securities and Exchange Commission (the “Commission”) take appropriate action
to cause the above-referenced Registration Statement on Form S-1, as amended, File No. 333-267562 (the “Registration Statement”),
to become effective on Thursday, January 19, 2023, at 5:00 p.m., Eastern Time, or as soon thereafter as is practicable.
The
Registrant understands that the Staff of the Commission will consider this request as confirmation by the Registrant that it is aware
of its responsibilities under the federal securities laws as they relate to the issuance of the securities covered by the Registration
Statement.
The
Registrant hereby authorizes its counsel, Leslie Marlow, Esq. or Jamie L. Plisner, Esq. of Blank Rome LLP, to orally modify or withdraw
this request for acceleration. Please contact Ms. Marlow at (212) 885-5358 or Ms. Plisner at (212) 885-5298 with any questions you may
have concerning this request, and please notify either Ms. Marlow or Ms. Plisner when this request for acceleration has been granted.
Very truly yours,
CADRENAL THERAPEUTICS, INC.
By:
/s/ Quang Pham
Name:
Quang Pham
Title:
Chairman of the Board and Chief Executive Officer
cc:
Leslie Marlow, Esq., Blank Rome LLP
Jamie L. Plisner, Esq., Blank Rome LLP
2023-01-17 - CORRESP - Cadrenal Therapeutics, Inc.
CORRESP
1
filename1.htm
Boustead Securities LLC
6 Venture #395
Irvine, CA 92618
January 17, 2023
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
Cadrenal Therapeutics, Inc.
Registration Statement on Form S-1, as amended
File No. 333-267562
Acceleration Request
Requested Date:
Thursday, January 19, 2023
Requested Time:
5:00 p.m. Eastern Time (US)
Ladies and Gentlemen:
In connection with the above-referenced Registration
Statement, and pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as the underwriters, hereby
join in the request of Cadrenal Therapeutics, Inc. that the effective date of the Registration Statement be accelerated so that it will
be declared effective at 5:00 p.m., Eastern Time (US), on Thursday, January 19, 2023, or at such later time as the Company or its outside
counsel, Blank Rome LLP, may request via a telephone call to the staff of the Division of Corporation Finance of the Securities and Exchange
Commission.
Pursuant to Rule 460 under the Act, we wish to
advise you that the underwriters have distributed as many copies of the Preliminary Prospectus dated January 17, 2023 to underwriters,
dealers, institutions and others as appears to be reasonable to secure adequate distribution of the preliminary prospectus.
The undersigned, as representatives of the underwriters,
have complied and will comply, and we have been informed by the participating underwriters that they have complied and will comply, with
Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
Very truly yours,
BOUSTEAD SECURITIES, LLC
By:
/s/ Keith Moore
Name:
Keith Moore
Title:
Chief Executive Officer
2022-12-08 - CORRESP - Cadrenal Therapeutics, Inc.
CORRESP
1
filename1.htm
Phone:
(212) 885-5358
Fax:
(917) 332-3824
Email:
leslie.marlow@blankrome.com
December 8, 2022
VIA EDGAR
United States Securities
and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Dillon Hagius
Re:
Cadrenal Therapeutics, Inc.
Amendment No. 3 to Registration Statement on Form S-1
Submitted on December 6, 2022
File No. 333-267562
Dear Mr. Haguis:
On behalf of our client, Cadrenal
Therapeutics, Inc. (the “Company”), we submit this letter in response to comments from the staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) contained in its letter dated December 8, 2022 (the “Comment
Letter”), relating to the above-referenced Amendment No. 3 to Registration Statement on Form S-1. We are concurrently submitting
via EDGAR Amendment No. 4 to Registration Statement on Form S-1 (“Amended Registration Statement No. 4”).
Set forth below is the comment
and caption from the Comment Letter. Immediately following the comment is the Company’s response to that comment in bold.
Amendment No. 3 to Registration
Statement on Form S-1
Cover Page
1. Disclose
whether your offering is contingent upon final approval of your Nasdaq listing on your cover page. Please ensure the disclosure is consistent
with your underwriting agreement.
Response: We have added disclosure on the cover
page that the offering is contingent upon final approval of our Nasdaq listing.
United States Securities
and Exchange Commission
December 8, 2022
Page 2
Risk Factors
Our stock price may be extremely
volatile, and your investment in our common stock could suffer a decline in value., page 44
2. We note recent instances of extreme stock
price run-ups followed by rapid price declines and stock price volatility seemingly unrelated to company performance following a number
of recent initial public offerings, particularly among companies with relatively smaller public floats. Please revise this risk factor
or include a separate risk factor addressing the potential for rapid and substantial price volatility and any known factors particular
to your offering that may add to this risk and discuss the risks to investors when investing in stock where the price is changing rapidly.
In addition, please clearly state that there is a risk of rapid and substantial price volatility and that any such volatility, including
any stock-run up, may be unrelated to your actual or expected operating performance and financial condition or prospects, which could
make it difficult for prospective investors to assess the rapidly changing value of your stock.
Response: We have revised our disclosure to
include a risk factor related to extreme stock price volatility seemingly unrelated to company performance following a number of recent
initial public offerings and the risk of rapid and substantial price volatility investors may experience related to our common stock following
our initial public offering.
If you have any questions
or need additional information, please contact the undersigned at (212) 885-5358 or Hank Gracin at (212) 885-5362.
Sincerely,
/s/ Leslie Marlow
Leslie Marlow
cc:
Quang Pham
Chief Executive Officer, Cadrenal Therapeutics, Inc.
2022-12-08 - UPLOAD - Cadrenal Therapeutics, Inc.
United States securities and exchange commission logo
December 8, 2022
Quang Pham
Chief Executive Officer
Cadrenal Therapeutics, Inc.
822 A1A North, Suite 320
Ponte Vedra, FL 32082
Re:Cadrenal Therapeutics, Inc.
Amendment No. 3 to Registration Statement on Form S-1
Filed December 6, 2022
File No. 333-267562
Dear Quang Pham:
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.
Amendment No. 3 to Registration Statement on Form S-1
Cover Page
1.Disclose whether your offering is contingent upon final approval of your Nasdaq listing
on your cover page. Please ensure the disclosure is consistent with your underwriting
agreement.
Risk Factors
Our stock price may be extremely volatile, and your investment in our common stock could
suffer a decline in value. , page 44
2.We note recent instances of extreme stock price run-ups followed by rapid price declines
and stock price volatility seemingly unrelated to company performance following a
number of recent initial public offerings, particularly among companies with relatively
FirstName LastNameQuang Pham
Comapany NameCadrenal Therapeutics, Inc.
December 8, 2022 Page 2
FirstName LastName
Quang Pham
Cadrenal Therapeutics, Inc.
December 8, 2022
Page 2
smaller public floats. Please revise this risk factor or include a separate risk factor
addressing the potential for rapid and substantial price volatility and any known factors
particular to your offering that may add to this risk and discuss the risks to investors when
investing in stock where the price is changing rapidly. In addition, please clearly state that
there is a risk of rapid and substantial price volatility and that any such volatility,
including any stock-run up, may be unrelated to your actual or expected operating
performance and financial condition or prospects, which could make it difficult for
prospective investors to assess the rapidly changing value of your stock.
You may contact Ibolya Ignat at 202-551-3636 or Al Pavot at 202-551-3738 if you have
questions regarding comments on the financial statements and related matters. Please contact
Dillon Hagius at 202-551-7967 or Jason Drory at 202-551-8342 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Leslie Marlow
2022-10-17 - CORRESP - Cadrenal Therapeutics, Inc.
CORRESP
1
filename1.htm
Phone:
(212) 885-5358
Fax:
(917) 332-3824
Email:
leslie.marlow@blankrome.com
October 17, 2022
VIA EDGAR
United States Securities
and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Attention: Dillon Hagius
Re:
Cadrenal Therapeutics, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Submitted on October 11, 2022
File No. 333-267562
Dear Mr. Haguis:
On behalf of our client, Cadrenal
Therapeutics, Inc. (the “Company”), we submit this letter in response to comments from the staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) contained in its letter dated October 13, 2022 (the “Comment
Letter”), relating to the above-referenced Amendment No. 1 to Registration Statement on Form S-1. We are concurrently submitting
via EDGAR Amendment No. 2 to Registration Statement on Form S-1 (“Amended Registration Statement No. 2”).
Set forth below is the comment
and caption from the Comment Letter. Immediately following the comment is the Company’s response to that comment in bold, including
a cross-reference to the location of changes made in Amended Registration Statement No. 2 in response to the Staff’s comment.
Amendment No. 1 to Registration
Statement on Form S-1
Public Offering Prospectus Summary
Our Business, page 1
1. Please balance your disclosure regarding the
tecarfarin patents on page 3 and 69 with additional disclosure that you have not engaged intellectual property counsel to conduct a freedom
to operate analysis and briefly explain how this impacts your certainty regarding your claims to the tecarfarin patents.
Response: We have made additional disclosure
on pages 3 and 69 that we have not engaged intellectual property counsel to conduct a freedom to operate analysis and we briefly explained
how this impacts our claims to the tecarfarin patents.
United States Securities
and Exchange Commission
October 17, 2022
Page 2
If you have any questions
or need additional information, please contact the undersigned at (212) 885-5358 or Hank Gracin at (212) 885-5362.
Sincerely,
/s/ Leslie Marlow
Leslie Marlow
cc:
Quang Pham
Chief Executive Officer, Cadrenal Therapeutics, Inc.
2022-10-13 - UPLOAD - Cadrenal Therapeutics, Inc.
United States securities and exchange commission logo
October 13, 2022
Quang Pham
Chief Executive Officer
Cadrenal Therapeutics, Inc.
822 A1A North, Suite 320
Ponte Vedra, FL 32082
Re:Cadrenal Therapeutics, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed October 11, 2022
File No. 333-267562
Dear Quang Pham:
We have reviewed your amended registration statement and have the following
comment.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comment applies 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 this comment, we may have additional comments.
Amendment No. 1 to Registration Statement on Form S-1
Public Offering Prospectus Summary
Our Business, page 1
1.Please balance your disclosure regarding the tecarfarin patents on pages 3 and 69
with additional disclosure that you have not engaged intellectual property counsel
to conduct a freedom to operate analysis and briefly explain how this impacts your
certainty regarding your claims to the tecarfarin patents.
You may contact Ibolya Ignat at 202-551-3636 or Al Pavot at 202-551-3738 if you have
questions regarding comments on the financial statements and related matters. Please contact
Dillon Hagius at 202-551-7967 or Jason Drory at 202-551-8342 with any other questions.
FirstName LastNameQuang Pham
Comapany NameCadrenal Therapeutics, Inc.
October 13, 2022 Page 2
FirstName LastName
Quang Pham
Cadrenal Therapeutics, Inc.
October 13, 2022
Page 2
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Leslie Marlow
2022-09-22 - CORRESP - Cadrenal Therapeutics, Inc.
CORRESP
1
filename1.htm
Phone:
(212)
885-5358
Fax:
(917)
332-3824
Email:
leslie.marlow@blankrome.com
September
22, 2022
VIA
EDGAR
United
States Securities and Exchange Commission
Division of Corporation Finance
100
F Street, N.E.
Washington, D.C. 20549
Attention: Dillon Hagius
Re: Cadrenal
Therapeutics, Inc.
Registration
Statement on Form S-1
Submitted
on August 23, 2022
CIK
No. 0001937993
Ladies
and Gentlemen:
On
behalf of Cadrenal Therapeutics, Inc. (the “Company”), set forth below is information in response to the fourth
bullet point in comment number 6 contained in the letter to the Company dated August 30, 2022 from the staff (the “Staff”)
of the Securities and Exchange Commission (the “Commission”) relating to the Draft Registration Statement on
Form S-1 that was confidentially submitted to the Commission on August 23, 2022. The supplemental response set forth below is based
upon information provided to Blank Rome LLP by the Company.
On
behalf of the Company, we are respectfully requesting confidential treatment for specified portions of this letter pursuant to Rule 83
promulgated by the Commission (17 C.F.R. § 200.83). This letter is accompanied by such request for confidential treatment because
of the commercially sensitive nature of the information discussed in this letter. A redacted version of this letter will be filed with
the Commission on EDGAR, omitting the confidential information.
DETERMINATION
OF FAIR VALUE OF COMMON STOCK
The
Company’s discussion of its accounting for stock-based compensation is primarily contained within the sections of the Registration
Statement on Form S-1 that is being filed with the Commission contemporaneously with this letter on September 22, 2022 (“Registration
Statement”) entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical
Accounting Policies and Significant Judgments and Estimates—“Stock-Based Compensation” and “Determination
of the Fair Value of Common Stock” (the “MD&A”) and appears on pages 65 through 66 of the Registration
Statement.
United
States Securities and
Exchange Commission
September
22, 2022
Page
2
As
described in the Registration Statement, the Company has historically determined the fair value of its common stock using methodologies,
approaches and assumptions consistent with the American Institute of Certified Public Accountants Accounting and Valuation Guide, Valuation
of Privately-Held-Company Equity Securities Issued as Compensation (the “Practice Guide”). Specifically,
the fair value of the shares of common stock underlying the Company’s stock options has been determined by the Company’s
Board of Directors (the “Board”). Because there has been no public market for the Company’s common stock,
and in the absence of recent arm’s-length cash sales transactions of the Company’s common stock with independent
third parties, the Board has determined the fair value of the common stock by considering a number of objective and subjective factors,
including an independent third-party valuation as of May 31, 2022.
Management
notes that during the period of time from our independent third-party valuation on May 31, 2022 through the date of this response, we
do not have any financing events indicating a certain fair value of our common stock and we have not had any material developments from
a science, regulatory or commercial standpoint. During this time, we hired a Chief Medical Officer in August 2022, we established a scientific
advisory board over the last four months, and took various progressive steps to file our Draft Registration Statement on Form S-1 and
get ready for Form S-1 effectiveness with the Commission.
At
each equity award grant date which occurred during the July 2022 to September 2022 time period, the Board evaluated any recent events
and their potential impact on the estimated fair value per share of the common stock. Please note that no single event caused the valuation
of the Company’s common stock to fluctuate. Instead, a combination of the Company’s progress toward an initial public offering
(“IPO”) and the probabilities of completing an IPO led to the changes in the fair value of the underlying common
stock. We used a probability of IPO weighted model leading up to our planned IPO from our last 409a valuation dated May 31, 2022. The
following probability percentages were used at the following dates:
● May
31, 2022 – [***] % probability
● June
30, 2022 – [***] % probability
● July
31, 2022 – [***] % probability
● August
30, 2022 – [***] % probability
● Subsequent
to this filing – 100% probability
The
estimated initial public offering price (the “IPO Price”) of $5.00 per share has been estimated based on a
number of factors, including current market conditions and input received from Boustead Securities, LLC (the “Underwriter”),
including discussions on September 15, 2022 among representatives of the Company and representatives of the Underwriter.
The
estimated IPO Price does not take into consideration the current lack of liquidity for the Company’s common stock and assumes a
successful IPO with no weighting attributed to any other outcome for the Company’s business, such as remaining a privately held
company or being sold in an acquisition transaction. As is typical for initial public offerings, the IPO Price was not derived using
a formal determination of fair value but was determined as a result of discussions among representatives of the Company and the Underwriter.
United
States Securities and
Exchange Commission
September
22, 2022
Page
3
Equity
Grants and Common Stock Valuations
Information
regarding equity grants to the Company’s employees and consultants since inception is summarized in the following table:
Grant
Date
Number
of
Shares Underlying
Stock
Options
Granted
Exercise
Price Per
Share
Common
Stock
Fair Value
Per Share
for Financial
Reporting
Aggregate
Grant
Date Fair
Value
for
Financial
Reporting
7/11/2022
600,000
$ 0.64 $
[***]
$ 222,000
8/18/2022
400,000
$ 0.64 $
[***]
$ 833,600
Grant
Date
Number
of
Common Shares Granted
Common
Stock
Fair Value
Per Share
for Financial
Reporting
Aggregate
Grant
Date Fair
Value for
Financial
Reporting
7/11/2022
46,875
[***]
$ 30,000
8/18/2022
80,000
[***]
$ 200,000
9/16/2022
100,000
[***]
$ 375,000
Conclusion
As
detailed in the Registration Statement and based on the above analysis, the Company respectfully submits to the Staff that it has fully
complied with the applicable rules and regulations for the determination of fair value, including the best practices outlined in the American
Institute of Certified Public Accountants Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation.
The Company will continue to monitor the topic for financial reporting purposes as it prepares its financial statements for the three
and nine months ended September 30, 2022 and determine whether further adjustment is appropriate.
The
Company advises the Staff that for stock-based compensation accounting purposes, the Company intends to use the IPO Price to value any
additional stock options granted hereafter until the time that there is a public market for its common stock.
If
you have any questions or need additional information, please contact the undersigned at (212) 885-5358 or Hank Gracin at (212) 885-5362.
Sincerely,
/s/
Leslie Marlow
Leslie
Marlow
cc:
Quang
Pham
Chief
Executive Officer, Cadrenal Therapeutics, Inc.
2022-08-30 - UPLOAD - Cadrenal Therapeutics, Inc.
United States securities and exchange commission logo
August 30, 2022
Quang Pham
Chief Executive Officer
Cadrenal Therapeutics, Inc.
822 A1A North, Suite 320
Ponte Vedra, FL 32082
Re:Cadrenal Therapeutics, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted August 23, 2022
CIK No. 0001937993
Dear Mr. Pham:
We have reviewed your amended draft 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 providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. 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 the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Amendment No. 1 to Draft Registration Statement on Form S-1
Risk Factors
Risks Related to Ownership of Our Common Stock
Our initial public offering price is substantially higher than the pro forma as adjusted net tangible
book value per share..., page 45
1.We note your revised disclosure in response to comment 10, including your disclosure
that pursuant to an Amended Asset Purchase Agreement with HESP LLC (the
"Amendment") you plan to issue shares of your common stock at a 40% discount to the
initial public offering price in lieu of $1.8 million in milestone payments. Please update
this risk factor or include an additional risk factor disclosure discussing the potential
dilutive impact of the potential share issuance under the Amendment.
FirstName LastNameQuang Pham
Comapany NameCadrenal Therapeutics, Inc.
August 30, 2022 Page 2
FirstName LastNameQuang Pham
Cadrenal Therapeutics, Inc.
August 30, 2022
Page 2
Market Opportunity, page 81
2.We note your response to comment 18, including your revised disclosure on page 81, and
reissue in part. Please revise to the remove the attribution to an unidentified third-party or
revise your filing to identify such third party and file a consent from such third-party.
Please see Securities Act Rule 436.
Data Exclusivity, page 84
3.We note your disclosure that "[u]pon approval of tecarfarin by the FDA, [you] will
receive five years of data exclusivity for [y]our tecarfarin NDA." Please balance your
disclosure here to clarify that tecarfarin may not be approved by the FDA. In addition,
please update your disclosure to discuss the type of exclusivity you believe tecarfarin may
be afforded and balance your disclosure to clearly state that the FDA may disagree with
your belief or otherwise advise.
Certain Relationships and Related Party Transactions, page 105
4.We note your response to comment 24. Please file the convertible promissory note with
John Murphy dated March 1, 2022 as an exhibit to the registration statement. We note the
exhibit previously filed as Exhibit 4.3 appears to be the Form of Convertible Note dated
March 1, 2022.
Principal Stockholders, page 107
5.Please identify in a footnote to the table all natural persons who have voting and/or
investment power over the shares held by HESP LLC.
Financial Statements
Notes to Financial Statements
Note 12. Subsequent Events, page F-17
6.Please respond to the following comments with regard to your subsequent events:
•Disclose the date through which subsequent events have been evaluated
and the nature of this date. Refer to ASC 855-10-50-1
•Disclose the August 8, 2022 and August 18, 2022 stock option grants awarded to
your Acting Chief Medical Officer discussed on pages 100 and 105
•Disclose here or in your MD&A the expected accounting for the elements of your
equity based instrument awards, the July 2022 Notes and the amendment of the Asset
Purchase Agreement.
•Once you have an estimated offering price or range, please explain to
us how you determined the fair value of the common stock underlying your equity
issuances and the reasons for any differences between the recent valuations of your
common stock leading up to the initial public offering and the estimated offering
price. This information will help facilitate our review of your accounting for equity
issuances including stock compensation. Please discuss with the staff how to submit
FirstName LastNameQuang Pham
Comapany NameCadrenal Therapeutics, Inc.
August 30, 2022 Page 3
FirstName LastName
Quang Pham
Cadrenal Therapeutics, Inc.
August 30, 2022
Page 3
your response.
You may contact Ibolya Ignat at 202-551-3636 or Al Pavot at 202-551-3738 if you have
questions regarding comments on the financial statements and related matters. Please contact
Dillon Hagius at 202-551-7967 or Jason Drory at 202-551-8342 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Leslie Marlow
2022-08-11 - UPLOAD - Cadrenal Therapeutics, Inc.
United States securities and exchange commission logo
August 11, 2022
Quang Pham
Chief Executive Officer
Cadrenal Therapeutics, Inc.
822 A1A North, Suite 320
Ponte Vedra, FL 32082
Re:Cadrenal Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted July 15, 2022
CIK No. 0001937993
Dear Mr. Pham:
We have reviewed your draft 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 providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. 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 the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-1 submitted July 15, 2022
Cover Page
1.Please revise the cover page to note that you will be a controlled company under Nasdaq
rules and, as a result, may elect not to comply with certain corporate governance
requirements.
FirstName LastNameQuang Pham
Comapany NameCadrenal Therapeutics, Inc.
August 11, 2022 Page 2
FirstName LastName
Quang Pham
Cadrenal Therapeutics, Inc.
August 11, 2022
Page 2
Prospectus Summary
Our Business , page 1
2.Please revise your disclosure here and upfront in your business section to:
•clarify how you acquired your product candidate, tecarfarin;
•identify the "previous owner"; and
•disclose that the eleven human clinical trials were conducted by third parties.
3.Please remove statements that tecarfarin is a "late-stage" therapy, as these statements
imply that your product is farther into the development process than it really is. We note
statements to this effect throughout the filing. Additionally, please revise to explain what
tecarfarin being "Phase 3- ready" means.
4.Please revise your statement that, in 2019, the FDA “concurred with the recommended
design of the remaining pivotal Phase 3 trial for tecarfarin, submitted by the previous
owner of tecarfarin” to remove any implication that the FDA has approved your Phase 3
trial design. Specifically, disclose that you have not received FDA input on your current
Phase 3 design and that there can be no assurance that the design will be accepted by the
FDA. We note risk factor disclosure to this effect on pages 15 and 16. Additionally,
disclose whether you are making any changes to the design of the Phase 3 trial for
tecarfarin that was submitted by the "previous owner" of tecarfarin and disclose the name
of this owner.
5.Please balance your statement that tecarfarin has generally been "well-tolerated in both
healthy adult subjects and patients" with disclosure discussing whether any severe adverse
advents have been observed that have been deemed to be related to tecarfarin and the
nature of any such events and the number of patients who experienced them. We note
your risk factor disclosure on page 25 that major hemorrhages occurred in 1.6% of the
blinded tecarfarin patients randomized in the EMBRACE-AC trial. In addition, we note
your disclosure on page 74 that at least one patient died due to intracerebral hemorrhage
that was considered to be possibly related to tecarfarin.
6.Please remove statements that: (1) tecarfarin may "potentially eliminate specific side
effects while maintaining or improving effectiveness" when compared to the most
commonly prescribed drugs for the treatment of thrombosis and AFib and; (2) that
tecarfarin "was designed to have the same well-established and reversible VKA
mechanism of action as warfarin, but to be free of certain potentially life-
threatening clearance and drug-to-drug interaction problems associated with warfarin."
These statements imply that your product candidate is safe and effective, which is a
determination solely within the authority of the FDA and comparable foreign regulatory
authorities. Remove similar statements from pages 58, 59, 64, and 71.
FirstName LastNameQuang Pham
Comapany NameCadrenal Therapeutics, Inc.
August 11, 2022 Page 3
FirstName LastName
Quang Pham
Cadrenal Therapeutics, Inc.
August 11, 2022
Page 3
7.Please provide balancing disclosure in the Prospectus Summary concerning the following:
•your history of net losses and limited operating history;
•the going concern opinion provided by your auditors;
•that you do not believe that the proceeds from this offering will provide you with
sufficient funds to complete the Phase 3 clinical trial for tecarfarin; and
•that your patents directed to tecarfarin expire in 2024.
Clinical Trials, page 3
8.Please disclose when the Phase 2/3 CLN-505 trial occurred and who sponsored the trial.
Additionally, balance your discussion of its results with disclosure that it did not achieve
statistical significance on its primary endpoint and the results of the primary analysis
showed that tecarfarin was not superior to warfarin as measured by TTR. Similarly revise
the discussion of this trial on page 66.
Our Strategy, page 3
9.Please revise the statement that you plan to expand your existing pipeline of
"investigational products" to clarify that you currently only have one investigational
product or otherwise advise.
Recent Events, page 3
10.Please disclose that you intend to use $1.8 million of this offering's proceeds to pay HESP
LLC pursuant to the terms of the Asset Purchase Agreement and clarify whether this
payment will impact the milestone payments that you owe to HESP LLC.
Summary of Risks Associated with Our Business, page 4
11.We note that your summary risk factors are four pages in length. Please revise to limit
to two pages and disclose only the principal factors that make an investment in the
registrant or offering speculative or risky, as required by Item 105(b) of Regulation S-K.
Risk Factors
Our amended and restated certificate of incorporation and amended and restated bylaws. . ., page
45
12.We note your disclosure that your amended and restated certificate of incorporation and
amended and restated bylaws will be in effect upon consummation of this offering. When
available, please file both documents as exhibits to the registration statement. Refer to
Item 601(b)(3) of Regulation S-K.
Use of Proceeds, page 52
13.Please revise to state how far in the clinical development of tecarfarin you expect to
proceed with the offering proceeds. We note your disclosure on page 14 that you will
need additional funding to enroll patients and complete the Phase 3 trial.
FirstName LastNameQuang Pham
Comapany NameCadrenal Therapeutics, Inc.
August 11, 2022 Page 4
FirstName LastNameQuang Pham
Cadrenal Therapeutics, Inc.
August 11, 2022
Page 4
Business, page 64
14.Your pipeline table on page 66 shows the clinical trial of tecarfarin for mechanical heart
valves has completed its Phase 2 trial; however, your disclosure states that the Phase 2
trial has not yet begun to enroll patients. Please reconcile and, if necessary, revise to
reduce the length of the arrow to accurately reflect the actual status of your pipeline
candidate as of the latest practicable date.
Our Investigational Product Candidate, page 68
15.We note your disclosure on page 69 that warfarin was initially marketed as rat poison.
Please explain why this is relevant to an investor's understanding of the current FDA
approved uses for warfarin. Relatedly, please provide the basis for your statement that,
"due to its side effects, the use of warfarin has decreased during the last decade."
Tecarfarin Clinical Program, page 71
16.We note that you do not disclose any narrative explanation for four of the 11 clinical trials
listed in this table (CLN-501, CLN-502, CLN-503, and CLN-509). Please describe the
results these trials or explain why you do not believe this information is material. In
addition, please update your summary table to disclose who sponsored each study.
Lee's Pharmaceutical Holdings Limited, page 76
17.Please file the LPH License as an exhibit to the registration statement or, alternatively,
provide your analysis supporting your belief that such filing is not required. See Item
601(b)(10) of Regulation S-K.
Market Opportunity, page 77
18.We note that you commissioned a 2019 study by Navigant/Guidehouse. Please analyze
whether you are required to file a consent pursuant to Rule 436 of the Securities Act and,
if necessary, file this consent or otherwise advise. Additionally, please balance your
statement concerning your estimated annual U.S. market revenue potential for tecarfarin
with disclosure that tecarfarin would first have to receive FDA approval to be sold in the
United States.
Summary of Safety and Tolerability of Tecarfarin, page 77
19.This section, including its sub-heading, implies that your product candidates are safe,
which is a determination solely within the authority of the FDA and comparable foreign
regulatory authorities. For example, it is not appropriate to state that
you believe "tecarfarin is at least as safe as warfarin and believe tecarfarin may show
improved safety, as measured by bleeding events, as compared to warfarin." Please
revise. In addition, we advise you that you may present the objective data from pre-
clinical and clinical trials without drawing a conclusion from the results.
FirstName LastNameQuang Pham
Comapany NameCadrenal Therapeutics, Inc.
August 11, 2022 Page 5
FirstName LastName
Quang Pham
Cadrenal Therapeutics, Inc.
August 11, 2022
Page 5
Intellectual Property, page 78
20.We note that both of your issued patents directed to tecarfarin expire in 2024 and that the
corresponding foreign patents expire in 2025. Please revise your disclosure to explain the
material impact, if any, of the patent expiration on your business. We note your risk
factor disclosure on page 37 that your "success depends in large part on [y]our ability to
obtain and maintain patent protection in the United States and other countries with respect
to [y]our proprietary product candidate."
21.We note only footnotes (1) and (2) to your list of U.S. and foreign patents discuss the type
of patent protection and which product candidates are covered by each patent. Please
revise your disclosure regarding your patent portfolio to clarify the specific product
candidate or technology to which each of these patents relate and identify the type of
patent protection (e.g., composition of matter, use, or process).
Management, page 89
22.We note that Quang Pham previously served as Espero CEO from 2015 until Espero's
"assets were assigned for the benefit of its creditors in July 2020." Please clarify the
nature of this assignment. Please provide the disclosures required by Item 401(f) of
Regulation S-K or otherwise advise.
Scientific Advisory Board (SAB), page 91
23.Please describe the role or function of the Scientific Advisory Board and whether there are
any rules or procedures governing such board. Additionally, please file the Scientific
Advisory Board and Consulting Agreement with Dr. Pokorney as an exhibit to the
registration statement or, alternatively, provide an analysis supporting your belief that
such filing is not required. Refer to Item 601(b)(10) of Regulation S-K.
Certain Relationships and Transactions , page 100
24.Please file the subscription agreements with Quang Pham dated January 25, 2022 and the
convertible promissory note with John Murphy dated March 1, 2022 as exhibits to the
registration statement or, alternatively, provide an analysis supporting your belief that
such filing is not required. Refer to Item 601(b)(10) of Regulation S-K.
25.We note your disclosure that you entered into an agreement with Phamace, LLC, a
consulting firm of which your chief executive officer is the sole member. Please update
your disclosure to more specifically describe the "services rendered."
FirstName LastNameQuang Pham
Comapany NameCadrenal Therapeutics, Inc.
August 11, 2022 Page 6
FirstName LastName
Quang Pham
Cadrenal Therapeutics, Inc.
August 11, 2022
Page 6
Material U.S. Federal Income Tax Considerations for Non-U.S. Holders of Our Common Stock,
page 110
26.Please remove the disclaimer on page 111 indicating that the discussion of material tax
considerations are provided "for informational purposes only" and the disclaimer on page
113 that this discussion is "for general information only." These statements imply that
investors are not entitled to rely on the disclosure in your registration statement
Exhibits
27.Please revise so that all agreements show the signatures or conformed signatures of all the
parties to the agreements. It appears, for example only, that Exhibit 10.7 and 10.8 do not
show signatures by all parties to the agreements.
General
28.Please supplementally provide us with copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
You may contact Ibolya Ignat at 202-551-3636 or Al Pavot at 202-551-3738 if you have
questions regarding comments on the financial statements and related matters. Please contact
Dillon Hagius at 202-551-7967 or Jason Drory at 202-551-8342 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Leslie Marlow