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Korro Bio, Inc.
Response Received
1 company response(s)
High - file number match
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Korro Bio, Inc.
Response Received
1 company response(s)
High - file number match
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Korro Bio, Inc.
Response Received
1 company response(s)
High - file number match
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Korro Bio, Inc.
Response Received
2 company response(s)
High - file number match
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Korro Bio, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-12-06
Korro Bio, Inc.
Filing - SEC Comment Letter to Korro Bio, Inc.
UPLOAD · 2023-12-06
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Korro Bio, Inc.
Response Received
4 company response(s)
High - file number match
SEC wrote to company
2023-08-24
Korro Bio, Inc.
Filing - SEC Comment Letter to Korro Bio, Inc.
UPLOAD · 2023-08-24
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Company responded
2023-08-31
Korro Bio, Inc.
References: August 23, 2023
Filing - Correspondence from Korro Bio, Inc.
CORRESP · 2023-08-31
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Company responded
2023-09-20
Korro Bio, Inc.
References: September 15, 2023
Filing - Correspondence from Korro Bio, Inc.
CORRESP · 2023-09-20
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Company responded
2023-12-01
Korro Bio, Inc.
References: November 17, 2023
Korro Bio, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2023-09-15
Korro Bio, Inc.
Filing - SEC Comment Letter to Korro Bio, Inc.
UPLOAD · 2023-09-15
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Korro Bio, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-11-19
Korro Bio, Inc.
Filing - SEC Comment Letter to Korro Bio, Inc.
UPLOAD · 2020-11-19
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Company responded
2020-11-20
Korro Bio, Inc.
Filing - Correspondence from Korro Bio, Inc.
CORRESP · 2020-11-20
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Korro Bio, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-09-01
Korro Bio, Inc.
Filing - SEC Comment Letter to Korro Bio, Inc.
UPLOAD · 2020-09-01
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Company responded
2020-09-01
Korro Bio, Inc.
Filing - Correspondence from Korro Bio, Inc.
CORRESP · 2020-09-01
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Korro Bio, Inc.
Response Received
4 company response(s)
Medium - date proximity
SEC wrote to company
2019-09-04
Korro Bio, Inc.
Filing - SEC Comment Letter to Korro Bio, Inc.
UPLOAD · 2019-09-04
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Company responded
2019-09-06
Korro Bio, Inc.
References: September 4, 2019
Filing - Correspondence from Korro Bio, Inc.
CORRESP · 2019-09-06
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Company responded
2019-09-13
Korro Bio, Inc.
References: August 13, 2019
Filing - Correspondence from Korro Bio, Inc.
CORRESP · 2019-09-13
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Company responded
2019-09-30
Korro Bio, Inc.
Filing - Correspondence from Korro Bio, Inc.
CORRESP · 2019-09-30
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Company responded
2019-09-30
Korro Bio, Inc.
Filing - Correspondence from Korro Bio, Inc.
CORRESP · 2019-09-30
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Korro Bio, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2019-08-13
Korro Bio, Inc.
Filing - SEC Comment Letter to Korro Bio, Inc.
UPLOAD · 2019-08-13
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-18 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2026-03-18 | SEC Comment Letter | Korro Bio, Inc. | DE | 333-294298 | Read Filing View |
| 2024-12-06 | SEC Comment Letter | Korro Bio, Inc. | DE | 333-283552 | Read Filing View |
| 2024-12-06 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2024-05-20 | SEC Comment Letter | Korro Bio, Inc. | DE | 333-279402 | Read Filing View |
| 2024-05-20 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2023-12-21 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2023-12-20 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2023-12-06 | SEC Comment Letter | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2023-12-01 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2023-11-17 | SEC Comment Letter | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2023-09-28 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2023-09-20 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2023-09-15 | SEC Comment Letter | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2023-08-31 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2023-08-24 | SEC Comment Letter | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2020-11-20 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2020-11-19 | SEC Comment Letter | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2020-09-01 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2020-09-01 | SEC Comment Letter | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2019-09-30 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2019-09-30 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2019-09-13 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2019-09-06 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2019-09-04 | SEC Comment Letter | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2019-08-13 | SEC Comment Letter | Korro Bio, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-18 | SEC Comment Letter | Korro Bio, Inc. | DE | 333-294298 | Read Filing View |
| 2024-12-06 | SEC Comment Letter | Korro Bio, Inc. | DE | 333-283552 | Read Filing View |
| 2024-05-20 | SEC Comment Letter | Korro Bio, Inc. | DE | 333-279402 | Read Filing View |
| 2023-12-06 | SEC Comment Letter | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2023-11-17 | SEC Comment Letter | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2023-09-15 | SEC Comment Letter | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2023-08-24 | SEC Comment Letter | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2020-11-19 | SEC Comment Letter | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2020-09-01 | SEC Comment Letter | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2019-09-04 | SEC Comment Letter | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2019-08-13 | SEC Comment Letter | Korro Bio, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-03-18 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2024-12-06 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2024-05-20 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2023-12-21 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2023-12-20 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2023-12-01 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2023-09-28 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2023-09-20 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2023-08-31 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2020-11-20 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2020-09-01 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2019-09-30 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2019-09-30 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2019-09-13 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
| 2019-09-06 | Company Response | Korro Bio, Inc. | DE | N/A | Read Filing View |
2026-03-18 - CORRESP - Korro Bio, Inc.
CORRESP 1 filename1.htm CORRESP VIA EDGAR March 18, 2026 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Mr. Tim Buchmiller Re: Korro Bio, Inc. Acceleration Request for Registration Statement on Form S-3 File No. 333-294298 Acceleration Request Requested Date: March 20, 2026 Requested Time: 4:15 p.m., Eastern Time Dear Mr. Buchmiller: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “ Act ”), Korro Bio, Inc. (the “ Company ”) hereby requests that the effective date of the above-referenced registration statement (the “ Registration Statement ”) be accelerated to March 20, 2026, at 4:15 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Goodwin Procter LLP, by calling Marianne Sarrazin at (415) 733-6134. If you have any questions regarding this request, please contact Marianne Sarrazin of Goodwin Procter LLP at (415) 733-6134. Sincerely, KORRO BIO, INC. /s/ Ram Aiyar Ram Aiyar President, Chief Executive Officer and Interim Chief Financial Officer Korro Bio, Inc. cc: Jeffrey Cerio, General Counsel, Korro Bio, Inc. Kingsley L. Taft, Esq., Goodwin Procter LLP Marianne Sarrazin, Esq., Goodwin Procter LLP
2026-03-18 - UPLOAD - Korro Bio, Inc. File: 333-294298
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 18, 2026 Ram Aiyar President, Chief Executive Officer and interim Chief Financial Officer Korro Bio, Inc. 60 First Street, 2nd Floor, Suite 250 Cambridge, MA 02141 Re: Korro Bio, Inc. Registration Statement on Form S-3 Filed March 13, 2026 File No. 333-294298 Dear Ram Aiyar: 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 Tim Buchmiller at 202-551-3635 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Marianne Sarrazin, Esq. </TEXT> </DOCUMENT>
2024-12-06 - UPLOAD - Korro Bio, Inc. File: 333-283552
December 6, 2024
Ram Aiyar
President and Chief Executive Officer
Korro Bio, Inc.
60 First Street, 2nd floor, Suite 250
Cambridge, MA 02141
Re:Korro Bio, Inc.
Registration Statement on Form S-3
Filed December 2, 2024
File No. 333-283552
Dear Ram Aiyar:
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:Marianne Sarrazin, Esq.
2024-12-06 - CORRESP - Korro Bio, Inc.
CORRESP 1 filename1.htm CORRESP VIA EDGAR December 6, 2024 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Mr. Daniel Crawford Re: Korro Bio, Inc. Acceleration Request for Registration Statement on Form S-3 File No. 333-283552 Acceleration Request Requested Date: December 6, 2024 Requested Time: 4:05 p.m., Eastern Time Dear Mr. Crawford: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Korro Bio, Inc. (the “Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to December 6, 2024, at 4:05 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Goodwin Procter LLP, by calling Marianne Sarrazin at (415) 733-6134. If you have any questions regarding this request, please contact Marianne Sarrazin of Goodwin Procter LLP at (415) 733-6134. Sincerely, KORRO BIO, INC. /s/ Vineet Agarwal Vineet Agarwal Chief Financial Officer Korro Bio, Inc. cc: Ram Aiyar, President, Chief Executive Officer and Director, Korro Bio, Inc. Jeffrey Cerio, General Counsel, Korro Bio, Inc. Kingsley L. Taft, Esq., Goodwin Procter LLP Marianne Sarrazin, Esq., Goodwin Procter LLP
2024-05-20 - UPLOAD - Korro Bio, Inc. File: 333-279402
United States securities and exchange commission logo
May 20, 2024
Ram Aiyar
President and Chief Executive Officer
Korro Bio, Inc.
One Kendall Square, Building 600-700
Suite 6-401
Cambridge, MA 02139
Re:Korro Bio, Inc.
Registration Statement on Form S-1
Filed May 14, 2024
File No. 333-279402
Dear Ram Aiyar:
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: Marianne C. Sarrazin, Esq.
2024-05-20 - CORRESP - Korro Bio, Inc.
CORRESP 1 filename1.htm CORRESP VIA EDGAR May 20, 2024 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Mr. Chris Edwards Re: Korro Bio, Inc. Acceleration Request for Registration Statement on Form S-1 File No. 333-279402 Acceleration Request Requested Date: May 22, 2024 Requested Time: 4:05 p.m., Eastern Time Dear Mr. Edwards: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Korro Bio, Inc. (the “Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to May 22, 2024, at 4:05 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Goodwin Procter LLP, by calling Marianne Sarrazin at (415) 733-6134. If you have any questions regarding this request, please contact Marianne Sarrazin of Goodwin Procter LLP at (415) 733-6134. Sincerely, KORRO BIO, INC. /s/ Vineet Agarwal Vineet Agarwal Chief Financial Officer Korro Bio, Inc. cc: Ram Aiyar, President, Chief Executive Officer and Director, Korro Bio, Inc. Shelby Walker, General Counsel, Korro Bio, Inc. Kingsley L. Taft, Esq., Goodwin Procter LLP Marianne Sarrazin, Esq., Goodwin Procter LLP
2023-12-21 - CORRESP - Korro Bio, Inc.
CORRESP 1 filename1.htm Acceleration Request VIA EDGAR December 21, 2023 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Ms. Doris Stacey Gama Mr. Joe McCann Re: Korro Bio, Inc. Acceleration Request for Registration Statement on Form S-1 File No. 333-275353 Acceleration Request Requested Date: December 22, 2023 Requested Time: 4:05 p.m., Eastern Time Dear Ms. Gama and Mr. McCann: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Korro Bio, Inc. (the “Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to December 22, 2023, at 4:05 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Goodwin Procter LLP, by calling Marianne Sarrazin at (415) 733-6134. If you have any questions regarding this request, please contact Marianne Sarrazin of Goodwin Procter LLP at (415) 733-6134. Sincerely, KORRO BIO, INC. /s/ Ram Aiyar Ram Aiyar President, Chief Executive Officer and Director Korro Bio, Inc. cc: Vineet Agarwal, Chief Financial Officer, Korro Bio, Inc. Shelby Walker, General Counsel, Korro Bio, Inc. Kingsley L. Taft, Esq., Goodwin Procter LLP Daniel Hughes, Esq., Goodwin Procter LLP
2023-12-20 - CORRESP - Korro Bio, Inc.
CORRESP 1 filename1.htm Response Letter Goodwin Procter LLP Three Embarcadero Center, 28th Floor San Francisco, CA 94111 goodwinlaw.com +1 (415) 733-6000 December 20, 2023 VIA EDGAR Office of Life Sciences Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street NE Washington, DC 20549 Attention: Ms. Doris Stacey Gama Mr. Joe McCann Re: Korro Bio, Inc. Amendment No. 1 to Registration Statement S-3 on Form S-1 Filed December 1, 2023 File No. 333-275353 Dear Ms. Gama and Mr. McCann: This letter is submitted on behalf of Korro Bio, Inc. (“Korro”) in response to the comment of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to Korro’s Amendment No. 1 to Registration Statement S-3 on Form S-1 (File No: 333-275353), filed on December 1, 2023 (the “Registration Statement”), as set forth in the Staff’s letter dated December 6, 2023 (the “Comment Letter”). In connection with this letter responding to the Comment Letter, the Company is concurrently filing Amendment No. 2 to Registration Statement S-3 on Form S-1 (“Amendment No. 2”), which reflects certain revisions to the Registration Statement in response to the Comment Letter as well as certain other changes. For reference purposes, the text of the Comment Letter has been reproduced herein with the response below the numbered comment. Amendment No.1 to Form S-3 on Form S-1 General 1. We note the representation in Section 3.4 of the Agreement and Plan of Merger, filed on July 14, 2023 as exhibit 2.1 to Frequency Therapeutics, Inc.’s Form 8-K, that Korro’s stockholders were required to consent to the merger. We further note your Form S-1 seeks to register the resale of securities issued to Korro’s security holders in connection with the merger. Please revise to identify all former affiliates of Korro reselling pursuant to this Form S-1 as underwriters and fix a selling price for the duration of their offering. See Securities Act Rule 145(c). RESPONSE: Korro respectfully acknowledges the Staff’s comment and while it respectfully disagrees with the Staff’s position regarding applicability of Rule 145(c), it has nevertheless revised the selling stockholder table to remove those selling stockholders who may have been deemed to be affiliates within the meaning of Rule 145(c) at the time of the vote on the merger. See pages 200-203. *** U.S. Securities and Exchange Commission December 20, 2023 Page 2 If you should have any questions or comments with respect to the foregoing, please contact me at (415) 733-6134 or via e-mail at msarrazin@goodwinlaw.com. Very truly yours, /s/ Marianne Sarrazin Marianne Sarrazin Cc: Ram Aiyar, Korro Bio, Inc. Vineet Agarwal, Korro Bio, Inc. Shelby Walker, Korro Bio, Inc. Kingsley L. Taft, Goodwin Procter LLP Daniel Hughes, Goodwin Procter LLP
2023-12-06 - UPLOAD - Korro Bio, Inc.
United States securities and exchange commission logo
December 6, 2023
Ram Aiyar
Chief Executive Officer
Korro Bio, Inc.
One Kendall Square, Building 600-700, Suite 6-401
Cambridge, MA 02139
Re:Korro Bio, Inc.
Amendment No. 1 to Registration Statement S-3 on Form S-1
Filed December 1, 2023
File No. 333-275353
Dear Ram Aiyar:
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 a 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 letter, we may have additional comments. Unless we note otherwise,
any references to prior comments are to comments in our November 17, 2023 letter.
Amendment No.1 to Form S-3 on Form S-1
General
1.We note the representation in Section 3.4 of the Agreement and Plan of Merger, filed on
July 14, 2023 as exhibit 2.1 to Frequency Therapeutics, Inc.'s Form 8-K, that Korro's
stockholders were required to consent to the merger. We further note your Form S-1 seeks
to register the resale of securities issued to Korro's security holders in connection with the
merger. Please revise to identify all former affiliates of Korro reselling pursuant to this
Form S-1 as underwriters and fix a selling price for the duration of their offering. See
Securities Act Rule 145(c).
FirstName LastNameRam Aiyar
Comapany NameKorro Bio, Inc.
December 6, 2023 Page 2
FirstName LastName
Ram Aiyar
Korro Bio, Inc.
December 6, 2023
Page 2
Please contact Doris Stacey Gama at 202-551-3188 or Joe McCann at 202-551-6262 with
any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Daniel Hughes, Esq.
2023-12-01 - CORRESP - Korro Bio, Inc.
CORRESP 1 filename1.htm CORRESP Goodwin Procter LLP Three Embarcadero Center, 28th Floor San Francisco, CA 94111 goodwinlaw.com +1 (415) 733-6000 December 1, 2023 VIA EDGAR Office of Life Sciences Division of Corporation Finance U.S. Securities and Exchange Commission 100 F Street NE Washington, DC 20549 Attention: Ms. Doris Stacey Gama Mr. Joe McCann Re: Korro Bio, Inc. Registration Statement on Form S-3 Filed November 6, 2023 File No. 333-275353 Dear Ms. Gama and Mr. McCann: This letter is submitted on behalf of Korro Bio, Inc. (“Korro”) in response to the comment of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to Korro’s Registration Statement on Form S-3 (File No: 333-275353), filed on November 6, 2023 (the “Registration Statement”), as set forth in the Staff’s letter dated November 17, 2023 (the “Comment Letter”). For reference purposes, the text of the Comment Letter has been reproduced herein with the response below the numbered comment. Concurrent with the submission of this Comment Letter, Korro is simultaneously filing an amendment to the Registration Statement on Form S-1. Registration Statement on Form S-3 General 1. We note that on November 3, 2023, Korro Bio, Inc completed its merger with Frequency Therapeutics Inc. Based on your public filings, we note that the business of the combined company is the business of Korro Bio and that you do expect to conduct any further development of Frequency Therapeutics’ legacy programs. We further note that Frequency Therapeutics’ executives resigned in connection with the closing and that you granted Frequency Therapeutics’ stockholders of record with a non-transferrable contingent value right relating to the disposition or monetization of Frequency Therapeutics’ MS Program. Given these circumstances, please tell us your basis for registering this transaction on Form S-3. See Use of Form S-8, Form 8-K, and Form 20-F by Shell Companies, Release No. 33-8587 (July 15, 2005) at n. 32 as reiterated in Special Purpose Acquisition Companies, Shell Companies, and Projections, Release No. 33-11048 (March 30, 2022) at n. 239 and accompanying text. U.S. Securities and Exchange Commission December 1, 2023 Page 2 RESPONSE: Korro respectfully acknowledges the Staff’s comment and advises the Staff that it believes that it continues to be eligible to use Form S-3 as it has never been a shell company within the meaning of Rule 405 under the Securities Act of 1933, as amended, (the “1933 Act”) and Rule 12b-2 under the Securities Exchange Act of 1934, as amended (the “1934 Act”), and was not a shell company at the time of its business combination with the private company, Korro Bio Ops, Inc. (formerly known as Korro Bio, Inc., or “Legacy Korro”), which is now its wholly-owned subsidiary. We refer to such transaction herein as the “Merger.” For periods prior to the Merger, Korro was known as Frequency Therapeutics, Inc., or “Frequency.” Background In Release No. 33-8587 (July 15, 2005) (the “Shell Company Release”), the Commission stated that it was adopting rules and rule amendments to protect investors by deterring fraud and abuse in our securities markets through the use of reporting shell companies. The Shell Company Release further notes that its “…rules target regulatory problems that it identified where shell companies have been used as vehicles to commit fraud and abuse our regulatory processes.” The Shell Company Release defined a shell company “… as a company, other than an asset-backed issuer, with: • no or nominal operations; and • either: • no or nominal assets; • assets consisting solely of cash and cash equivalents; or • assets consisting of any amount of cash and cash equivalents and nominal other assets.” Analysis Korro respectfully submits that Frequency was not at any time prior to the Merger, a shell company. The Merger was between two operating pre-commercial life sciences companies, and was consummated only after Frequency registered the issuance of its securities on Form S-4 (File No. 333-273490) (“Form S-4”), which Form S-4 was subject to a thorough comment and review process by the Staff, and received the affirmative vote of 95% of the votes cast by Frequency’s stockholders. At no time during the Form S-4 review process did the Staff question whether or not Frequency was (or would become prior to the Merger) a shell company. Notably: • Since Frequency’s 2019 underwritten initial public offering (“IPO”), Frequency was an operating biotech company focused on developing its product candidates, such as its former leading product candidate FX-322 for individuals with sensorineural hearing loss and its product candidate for individuals living with multiple sclerosis (the “MS Program”); • Frequency represented that it was not a shell company in that certain Agreement and Plan of Merger by and among Frequency, a merger subsidiary and Legacy Korro dated as of July 14, 2023 (the “Merger Agreement”), as well as in its 1934 Act filings; • Frequency continued its business operations, with employees, processes and plans in place to support its employees, including operating contracts and more than nominal other assets through the Merger and assumed the operations of Legacy Korro upon completion of the Merger; • The use of a contingent value right (“CVR”) is not a sham transaction intended to temporarily park assets in a company to avoid shell company status only to revert them to promoters at a later date; and • Frequency was incentivized to increase its cash position prior to completion of the Merger to increase the ownership of the combined company, Korro, by its stockholders. As discussed in Frequency’s filings with the Commission, since its IPO, Frequency focused on developing therapeutic product candidates using its proprietary progenitor cell activation approach. In February 2023, Frequency’s leading product candidate, FX-322, failed to achieve its primary endpoint in a Phase 2a/2b clinical trial. As a result, Frequency shifted its focus to its MS Program and began to explore strategic U.S. Securities and Exchange Commission December 1, 2023 Page 3 alternatives to fund the future development of the MS Program, including the sale of the MS Program. While pursuing development of the MS Program, Frequency also explored a potential strategic transaction involving all of Frequency. To align its resources with its new development focus on the MS Program, Frequency’s Board of Directors (as described in detail in the “Background of the Merger” section of the Form S-4) took steps to preserve its cash resources with a view towards maximizing value for its stockholders. Such actions were not taken with a view towards becoming a shell company. Like many similarly situated pre-commercial biotech companies,1 Frequency was not able to secure funding to continue the development of the MS Program at a valuation that the Board of Directors believed maximized value for its stockholders. Accordingly, the Board of Directors ultimately determined to pursue a reverse merger transaction, the Merger, with Legacy Korro. Frequency continued to maintain employees to support the MS Program, related intellectual property assets and contracts while it sought to monetize such assets for the benefit of its stockholders. Throughout the period between signing and closing of the Merger, Frequency believed in good faith that it was not a shell company. Frequency functioned as an operating company and did not check the “shell company” box on the cover of its Form 10-Q filed November 2, 2023, the day prior to closing the Merger. Frequency confirmed the truthfulness and accuracy of its representations and warranties in the Merger Agreement. At the time of entry into the Merger Agreement in July 2023, Frequency continued to have approximately ten employees, processes and plans in place to support its employees, including operating contracts and more than nominal other assets. Such employees were essential to the continued functioning of Frequency’s operations as a viable biotech enterprise as there was no guarantee that it would be able to successfully consummate the Merger. While Frequency continued to preserve its MS Program assets, its primary non-cash asset for GAAP purposes was its right of use asset in its operating lease. Because Frequency intended to shift its headquarters to those of Legacy Korro effective upon closing of the Merger (as it did not need two operating leases to support its intended future business), Frequency took steps to renegotiate its lease following execution of the Merger Agreement, and in August 2023, Frequency terminated its lease (and sublease) effective January 2024 (see Form 8-K filed August 15, 2023). While for accounting purposes this termination led to a reduction in the right of use asset and significant increase in cash and cash equivalents, Frequency still had almost $5 million of non-cash assets at the time of the Merger, which included its operating lease, prepaid operating expenses, and property and equipment. Frequency’s senior leadership team did not resign until its successors were ready to step in. The sale of Frequency’s MS Program did not close until after the Merger. While Frequency streamlined its prior operations in anticipation of closing of the Merger, such steps were taken not with a view to abuse the securities markets, but to increase its net cash at closing and ownership of the combined company for its stockholders post-Merger. For GAAP purposes Frequency’s assets became largely cash and cash equivalents due to the reduction in the right of use asset, but for practical purposes, Frequency had not significantly changed its operations, it continued to have more than nominal other assets, and did not somehow become a shell company simply because of the GAAP accounting treatment of the termination of an operating lease. Even without the Merger Agreement, had Frequency simply chosen to reduce its real estate footprint while shifting its focus to the MS Program, the GAAP result would be the same (reduction in the right of use asset and significant increase in cash and cash equivalents). This, however, would not somehow make Frequency into a shell company. 1 Life sciences reverse mergers that closed in 2023 to date include: Tourmaline Bio/Talaris Therapeutics, Inc.; Notable Labs Ltd/Vascular Biogenics Ltd.; Morphimmune Inc/Immunome, Inc.; Dianthus Therapeutics, Inc./Magenta Therapeutics, Inc., CervoMed, Inc./Diffusion Pharmaceuticals, Inc.; Elicio Therapeutics, Inc./Angion Biomedica Corp.; Adamnis Pharmaceuticals/DMK Pharmaceuticals; CalciMedica, Inc./Graybug Vision, Inc.; Carisma Therapeutics, Inc./Sesen Bio, Inc.; Enliven Therapeutics, Inc., Imara, Inc. U.S. Securities and Exchange Commission December 1, 2023 Page 4 While the Staff notes the existence of the CVR agreement in its Comment Letter, the use of the CVR is not equivalent to a sham transaction where a promoter places assets into a company simply to have other than “nominal assets” only to have them returned at a later date (e.g., the abusive transaction highlighted in note 32 of the Shell Company Release). As described in detail in the Form S-4, here, the CVRs covered the MS Program, an asset that Frequency had been developing internally and investing substantial time and resources on. Because CVRs have the potential to capture benefits of pre-merger assets for the pre-merger stockholders, CVRs are commonly used in merger transactions as a tool to capture as much value as possible for pre-merger stockholders and thus increase likelihood of stockholder approval of the deal (and avoid claims that the Board did not strike the best deal possible). CVRs are not intended as a cover to somehow return assets to a promoter that were only temporarily placed into an entity to avoid shell company status. As is typical in reverse merger transactions, Frequency’s value to a potential reverse merger partner was driven by (a) its anticipated net cash at closing, (b) its stock exchange listing, and (c) its status as an operating (non-shell) company. Given the additional limitations under U.S. securities laws that arise due to shell company/former shell company status, Frequency’s attractiveness as a merger partner increased by not being (or becoming) a shell company. Frequency’s status as an operating company allowed it to negotiate terms and command valuations that it would not otherwise have been able to pursue as a shell company. These negotiated terms maximized Frequency’s value for its stockholders (which actively traded shares through closing of the Merger). Legacy Korro would not have agreed to pursue the Merger with Frequency at the agreed Frequency implied valuation if Frequency was (or would become) a shell company. Legacy Korro bargained for a representation and warranty from Frequency in Section 4.7(i) of the Merger Agreement that Frequency had not been and was not currently a “shell company” as defined in the 1934 Act. Frequency was incentivized to maximize value for its stockholders as it worked towards completion of the Merger, but did not intend that such efforts would result in a violation of its representations and warranties in the Merger Agreement nor that such efforts would result in it becoming a “shell company” and thus not delivering the benefit that Legacy Korro bargained for. If Frequency maintained status quo between signing and closing of the Merger merely to avoid inadvertently becoming a shell company, it would have continued to utilize cash resources, thereby decreasing the potential overall ownership of the combined company by its stockholders (based on its net cash at closing); a result seemingly at odds with the objective of maximizing value for stockholders. Not only would such requirement burn cash, it also doesn’t take into account the benefits of the potential Merger to Frequency’s stockholders and the bargained for opportunity to become stockholders of the combined company, which would have the potential to generate substantial long-term value for all of its stockholders (see, e.g., Frequency’s Reasons for the Merger in the Form S-4). In the Special Purpose Acquisition Companies, Shell Companies, and Projections, Release No. 33-11048 (March 30, 2022) (the “SPAC Release”), the Commission proposed new rules and rule amendments to enhance existing disclosure requirements and investor protections in IPOs by special purpose acquisition companies (“SPACs”) and in de-SPAC transactions. Frequency, however, was not a SPAC; it was not formed by a sponsor to seek out a target acquisition. Frequency was a clinical-stage regenerative medicine company focused on developing therapeutics, which conducted a traditional underwritten IPO in September 2019 led by three bulge bracket banks. Unfortunately, despite efforts to execute on its pre-clinical and clinical development plan, Frequency did not achieve the primary endpoints in its clinical trials and shifted its focus in February 2023 to maximize value to its stockholders. Frequency did not change its focus and pursue the Merger and enter into the CVR agreement in order to abuse the securities markets, nor did Frequency morph into a shell company or a SPAC or cloak itself with nominal assets to avoid being deemed a shell company as it pursued strategic alternatives. Frequency engaged a financial advisor, negotiated the Merger Agreement after a lengthy and formal process, its Board received a fairness opinion, it registered the issuance of securities in the Merger on Form S-4, the Form S-4 was subject to an extensive review and comment process by the Staff and included fulsome disclosure regarding Legacy Korro’s business (equivalent to that if Legacy Korro had filed on Form S-1 for a traditional IPO), and
2023-11-17 - UPLOAD - Korro Bio, Inc.
United States securities and exchange commission logo
November 17, 2023
Ram Aiyar
Chief Executive Officer
Korro Bio, Inc.
One Kendall Square, Building 600-700, Suite 6-401
Cambridge, MA 02139
Re:Korro Bio, Inc.
Registration Statement on Form S-3
Filed November 6, 2023
File No. 333-275353
Dear Ram Aiyar:
We have conducted a limited review of your 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 a 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 letter, we may have additional comments.
Registration Statement on Form S-3
General
1.We note that on November 3, 2023, Korro Bio, Inc completed its merger with Frequency
Therapeutics Inc. Based on your public filings, we note that the business of the combined
company is the business of Korro Bio and that you do expect to conduct any further
development of Frequency Therapeutics' legacy programs. We further note that Frequency
Therapeutics' executives resigned in connection with the closing and that you granted
Frequency Therapeutics' stockholders of record with a non-transferrable contingent value
right relating to the disposition or monetization of Frequency Therapeutics' MS
Program. Given these circumstances, please tell us your basis for registering this
transaction on Form S-3. See Use of Form S-8, Form 8-K, and Form 20-F by Shell
Companies, Release No. 33-8587 (July 15, 2005) at n. 32 as reiterated in Special Purpose
Acquisition Companies, Shell Companies, and Projections, Release No. 33-11048 (March
30, 2022) at n. 239 and accompanying text.
FirstName LastNameRam Aiyar
Comapany NameKorro Bio, Inc.
November 17, 2023 Page 2
FirstName LastName
Ram Aiyar
Korro Bio, Inc.
November 17, 2023
Page 2
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.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Doris Stacey Gama at 202-551-3188 or Joe McCann at 202-551-6262 with
any other questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Daniel Hughes, Esq.
2023-09-28 - CORRESP - Korro Bio, Inc.
CORRESP 1 filename1.htm CORRESP Frequency Therapeutics, Inc. 75 Hayden Avenue, Suite 300 Lexington, MA 02421 September 28, 2023 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, D.C. 20549 Re: Frequency Therapeutics, Inc. Registration Statement on Form S-4 (File No. 333-273490) Ladies and Gentlemen: In accordance with Rule 461 of the General Rules and Regulations under the Securities Act of 1933, as amended, Frequency Therapeutics, Inc. (the “Company”) hereby requests acceleration of the effective date of its Registration Statement on Form S-4 initially filed on July 27, 2023 and amended on September 1, 2023, September 21, 2023 and September 28, 2023 (the “Registration Statement”). The Company respectfully requests that the Registration Statement become effective as of 4:00 p.m., Eastern Time, on September 29, 2023, or as soon thereafter as practicable. Once the Registration Statement has been declared effective, please orally confirm that event with the Company’s counsel, Latham & Watkins LLP, by calling Jennifer A. Yoon at (617) 880-4540. Very truly yours, Frequency Therapeutics, Inc. By: /s/ David Lucchino Name: David Lucchino Title: President and Chief Executive Officer cc: Jennifer A. Yoon, Esq., Latham & Watkins LLP John H. Chory, Esq., Latham & Watkins LLP Bradley C. Faris, Esq., Latham & Watkins LLP
2023-09-20 - CORRESP - Korro Bio, Inc.
CORRESP
1
filename1.htm
CORRESP
200 Clarendon Street
Boston,
Massachusetts 02116
Tel: +1.617.948.6000 Fax: +1.617.948.6001
www.lw.com
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September 20, 2023
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United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549-6010
Attention: Cindy Polynice
Alan Campbell
Sasha Parikh
Mary Mast
Re: Frequency Therapeutics, Inc.
Amendment No. 1 to Registration Statement on Form S-4
Filed September 1, 2023
File No. 333-273490
Ladies and Gentlemen:
On behalf of Frequency
Therapeutics, Inc., a Delaware corporation (the “Company”), we are providing this letter in response to comments received from the staff (the “Staff”) of the Securities and Exchange Commission (the
“Commission”) by letter dated September 15, 2023 (the “Comment Letter”) with respect to the Company’s Amendment No. 1 to Registration Statement on Form
S-4, as filed on September 1, 2023 (“Amendment No. 1”).
In connection with this letter responding to the Comment Letter, the Company is concurrently filing Amendment No. 2 to the Company’s
Registration Statement on Form S-4 (“Amendment No. 2”), which reflects certain revisions to Amendment No. 1 in response to the Comment Letter as
well as certain other changes.
For ease of review, we have set forth below each of the numbered comments of the Comment Letter in bold
type, followed by the Company’s responses thereto. Unless otherwise indicated, capitalized terms used herein have the meanings assigned to them in Amendment No. 2 and all references to page numbers in such responses are to page numbers in
Amendment No. 2.
September 20, 2023
Page
2
Amendment No. 1 to Registration Statement on Form S-4
filed September 1, 2023
Prospectus Summary
Korro Bio, Inc., page 14
1.
Please revise this section or elsewhere in your registration statement, as appropriate, to disclose
(i) how Korro Bio currently expects to allocate the proceeds from the Pre-Closing Financing and Frequency Net Cash among its development programs and (ii) how far Korro Bio currently expects to reach
in its development programs with these proceeds.
Response: The Company respectfully acknowledges the
Staff’s comment and has revised the disclosure on pages 15-16 and 354-355 of Amendment No. 2.
Korro Bio’s Pipeline, page 16
2.
We note your response to prior comment 14. Please provide us with an analysis as to why each of the four
programs other than Korro Bio’s AATD program is sufficiently material to Korro Bio to merit inclusion in the pipeline chart on an individual basis. In your analysis, please address the projections disclosed elsewhere in the prospectus which do
not appear to contemplate Korro Bio recognizing material revenue from any program other than the AATD program prior to December 31, 2045. Please also tell us the amounts of proceeds from the Pre-Closing
Financing and Frequency Net Cash that are anticipated to be allocated to each of these programs. Alternatively, please remove these programs from the pipeline chart.
Response: The Company respectfully acknowledges the Staff’s comment and has revised the pipeline chart on pages 18, 288 and
297 of Amendment No. 2, as well as included disclosure regarding expected use of the cash, cash equivalents and marketable securities upon completion of the Merger (on pages 15-16 and 354-355 of Amendment No. 2), accordingly.
The Company notes for the Staff that it has removed the pipeline program for severe Alcoholic Hepatitis (sAH) from the pipeline chart graphic
even though it believes it is material. For competitive reasons, Korro Bio is not yet disclosing the intended target. The Company further directs the Staff’s attention to the analysis below of the materiality of each of the other pipeline
programs in Korro Bio’s pipeline chart (including the now removed sAH program).
As disclosed in Amendment No. 2, Korro Bio was
founded on a proprietary RNA-editing platform (OPERA) and funded with a goal of developing a novel class of RNA editing therapies using learnings from a combination of genetics and approved medicines (see
pages 20 and 290 of Amendment No. 2). The Company further respectfully advises the Staff that Korro Bio believes that each of its other pipeline programs (other than the AATD program) on an individual basis is material to Korro Bio because
each demonstrates the versatility of the oligonucleotide-based ADAR-mediated RNA editing approach to bring additional precision and tunability to address a broad range of rare and highly prevalent diseases (see pages 17 and 287 of Amendment
No. 2), which is a key component of Korro Bio’s business.
Each of these additional pipeline programs is material to Korro Bio
and merits inclusion in the pipeline chart because:
•
They are material to an investment decision in Korro Bio. Korro Bio engaged in extensive due
diligence discussions with investors in the Pre-Closing Financing. These investors, who collectively agreed to purchase approximately $117.3 million of Korro Bio common stock in the Pre-Closing Financing (as disclosed on page 18 and elsewhere in Amendment No. 2), were focused on the versatility and broad potential of the OPERA Platform and applicability of the RNA editing technology.
Discussions with these investors focused on both the AATD program, as it is the most advanced, but also the extensive pre-clinical studies and development work to support Korro Bio’s earlier stage
programs in Parkinson’s disease, amyotrophic lateral sclerosis (ALS), subsets of pain (collectively the three other indications in the pipeline chart), as well as other undisclosed targets for sAH and cardiometabolic disease.
2
September 20, 2023
Page
3
•
They are supported by pre-clinical studies. As disclosed on
pages 19, 287-289, and 311-316 of Amendment No. 2, Korro Bio has done multiple pre-clinical studies that demonstrate its ability to repair a pathogenic variant (Parkinson’s disease program),
prevent protein aggregation (ALS) and selectively modulate ion channels (subsets of pain). The additional programs and the pre-clinical proof-of-concept data generated to date evidence that Korro Bio’s
RNA editing technology is a novel way to potentially alleviate disease and, if developed successfully and approved, provide tangible benefit to patients. Korro Bio has also done similar work (and included similar disclosure) for its sAH program,
which is no longer included in the updated pipeline chart given the undisclosed nature of the target.
•
They are covered by extensive intellectual property. As disclosed on pages 319-320 of
Amendment No. 2, Korro Bio has a broad intellectual property portfolio that supports these additional pipeline programs.
The Company has also included the graphic below, as a reference guide for the Staff for the fulsome details in Amendment No. 2 regarding
each Korro Bio program included in the updated pipeline chart other than AATD, supporting the materiality of each program on an individual basis to Korro Bio and, upon completion of the Merger, the combined company.
The Company further respectfully advises the Staff that all of Korro Bio’s pipeline programs were
considered by the Company while evaluating the potential of the combined company to generate future value for stockholders. As disclosed in the sections titled “Background of the Merger” (beginning on page 157 of Amendment No. 2)
and “Frequency’s Reasons for the Merger” (beginning on page 170 of Amendment No. 2), the Company evaluated and selected Korro Bio as a merger partner because of, among other things, the potential for success for Korro
Bio’s platform technology (page 163 of Amendment No. 2), including the potential value of Korro Bio’s product candidate development (page 170 of Amendment No. 2); the opportunity for Korro Bio’s RNA editing
technology to generate substantial long-term value for the combined company and its stockholders (page 171 of Amendment No. 2); and Korro Bio’s focus on RNA editing technology to leverage genetics transiently, expanding the target
space to intervene in biology in a unique manner (page 171 of Amendment No. 2).
As for the Staff’s request to address why
the projections used do not appear to contemplate Korro Bio recognizing material revenue from any program other than the AATD program prior to December 31, 2045, the Company respectfully submits to the Staff that the projections used by the
Company’s board of directors were provided for the limited purpose of assessing the value of Korro Bio’s business. Within this context, the Company determined to focus on Korro Bio’s most advanced program in AATD, which was the first
product candidate likely to generate revenue for the combined company, and used the potential revenue streams from the AATD program to support its valuation of Korro Bio.
Further, while the Company acknowledges the Staff’s request to disclose the amounts of proceeds from the
Pre-Closing Financing and Frequency Net Cash that are anticipated to be allocated to programs other than the AATD program, the Company respectfully advises the Staff that it has revised the disclosure on
pages 15-16 and 354-355 of Amendment No. 2 to reflect its expected use of the cash, cash equivalents and marketable securities after completion of the Merger. As a pre-clinical company, Korro Bio has
not yet begun to track spending on a program by program basis and has not allocated its spending on a program by program basis. As disclosed on page 355 of Amendment No. 2, Korro Bio plans to track program costs upon nomination of a
development candidate or filing of an Investigational New Drug application.
3
September 20, 2023
Page
4
Korro Bio’s Strategy, page 19
3.
We note your response to prior comment 16 and revised disclosure. Please revise here and on page 289 to
provide the basis for your statements that Korro Bio has “position as a leader” in RNA editing.
Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 20 and 290 of
Amendment No. 2.
Background of the Merger, page 156
4.
We note your response to prior comment 19 and revised disclosure. Please revise further to disclose why the
Frequency Board modified its position regarding the valuation of Korro Bio and Frequency’s equity premium. Alternatively, please advise.
Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 168 of Amendment
No. 2.
Financial Analyses, page 177
5.
We note your response to prior comment 22 and re-issue in part.
Please disclose the stage of development of each company presented in the comparable company analysis. Please also present the estimated enterprise value for each selected company in the comparable company analysis and disclose whether TD Cowen
applied any discount factor to companies at a more advanced stage of development than Korro Bio. You may state that individual estimated enterprise values of each selected company were not independently determinative or utilized in deriving the
results of TD Cowen’s selected publicly traded companies analysis.
Response: The Company respectfully
acknowledges the Staff’s comment and has revised the disclosure on pages 178-179 of Amendment No. 2.
6.
We note your response to prior comment 23. Please revise to disclose whether TD Cowen’s DCF analysis
incorporated the possibility that Korro Bio’s products are not approved and/or Korro Bio does not achieve profitability.
Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 179 of Amendment
No. 2.
Certain Unaudited Financial Projections for Korro Bio, page 179
7.
We note your response to prior comment 24 and re-issue. Please
revise to disclose the extent to which the Frequency Board considered the Korro Bio Projections in making its decision to approve the Merger. To the extent the Frequency Board considered the Korro Bio Projections, please disclose whether the
Frequency Board determined that the time period and revenue figures presented in the projections were reasonable and, if so, the reasons underlying these determinations.
4
September 20, 2023
Page
5
Response: The Company respectfully acknowledges the Staff’s comment and has
revised the disclosure on page 182 of Amendment No. 2.
Key Advantages of Oligonucleotide-Based ADAR-Mediated RNA Editing as a Therapeutic
Modality, page 292
8.
We note your response to prior comment 29 and re-issue. We note your
disclosure in the graphic that oligo-based RNA editing has precedented delivery, tolerability and manufacturing as well as multiple approved products. Please revise the graphic to reconcile these claims with your statements in Risk Factors that
Korro Bio is uncertain how it will deliver product candidates to target tissues, RNA editing is a novel technology that has not yet been validated for human therapeutic use, Korro Bio is not aware of clinical trials being completed by third parties
using RNA editing or similar technologies, regulators have not established definitive guidelines for oligonucleotide drugs and no gene editing therapeutic product has been approved in the U.S. or Europe.
Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 17-18, the risk factor on page 104 and pages 289 and 301 of Amendment No. 2 to clarify the uncertainty. The Company supplementally informs the Staff that there are currently three approved
oligonucleotide products that leverage various delivery modalities, including lipid nanoparticles, or LNP, for liver tissue (ONPATTRO®), GalNAC conjugates for liver tissue (LEQVIO®) and unconjugated oligonucleotides for neuronal cells (SPINRAZA®). For Korro Bio’s first product, focused on AATD, Korro Bio is using
LNP for delivery to liver tissue. The delivery modality is not the limiting factor for Korro Bio’s current pipeline that targets liver tissue as evidenced by the three approved oligonucleotide products referenced above. In contrast, the
limitation is the risk-benefit profile that indicates clinical benefit with acceptable safety benefits as determined by the relevant regulatory authorities. The Company has also added clarifying language to the graphic on page 293 of Amendment
No 2, including cautionary language regarding the uncertainties faced by Korro Bio’s novel technologies.
Patent Portfolio, page 318
9.
We note your response to prior comment 32 and re-issue in part.
Please revise to disclose for each material patent and patent application the subject matter to which such patents or patent applications relate and the type of patent protection. In your revisions, please discuss the patent protection for your lead
product candidate(s).
Response: The Company respectfully acknowledges the Staff’s comment and has
revised the disclosure on pages 319-320 of Amendment No. 2.
* * *
We hope the foregoing answers are responsive to your comments. Please do not hesitate to contact me by telephone at (617) 880-4540 with any questions or comments regarding this correspondence.
5
September 20, 2023
Page
6
Very truly yours,
/s/ Jennifer A. Yoon
Jennifer A. Yoon, Esq.
of LATHAM &
WATKINS LLP
cc:
David Lucchino, President and Chief Executive Officer, Frequency Therapeutics, Inc.
Ram Aiyar, President and Chief Executive Officer, Korro Bio, Inc.
John H. Chory, Esq., Latham & Watkins LLP
Bradley C. Faris, Esq., Latham & Watkins LLP
Kingsley L. Taft, Esq., Goodwin Procter LLP
Marianne C. Sarrazin, Esq., Goodwin
2023-09-15 - UPLOAD - Korro Bio, Inc.
United States securities and exchange commission logo
September 15, 2023
David Lucchino
President and Chief Executive Officer
Frequency Therapeutics, Inc.
75 Hayden Avenue, Suite 300
Lexington, MA 02421
Re:Frequency Therapeutics, Inc.
Amendment No. 1 to Registration Statement on Form S-4
Filed September 1, 2023
File No. 333-273490
Dear David Lucchino:
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 August 23, 2023 letter.
Amendment No. 1 to Registration Statement on Form S-4 filed September 1, 2023
Prospectus Summary
Korro Bio, Inc., page 14
1.Please revise this section or elsewhere in your registration statement, as appropriate, to
disclose (i) how Korro Bio currently expects to allocate the proceeds from the Pre-Closing
Financing and Frequency Net Cash among its development programs and (ii) how far
Korro Bio currently expects to reach in its development programs with these proceeds.
Korro Bio's Pipeline, page 16
2.We note your response to prior comment 14. Please provide us with an analysis as to why
each of the four programs other than Korro Bio's AATD program is sufficiently material
FirstName LastNameDavid Lucchino
Comapany NameFrequency Therapeutics, Inc.
September 15, 2023 Page 2
FirstName LastName
David Lucchino
Frequency Therapeutics, Inc.
September 15, 2023
Page 2
to Korro Bio to merit inclusion in the pipeline chart on an individual basis. In your
analysis, please address the projections disclosed elsewhere in the prospectus which do
not appear to contemplate Korro Bio recognizing material revenue from any program
other than the AATD program prior to December 31, 2045. Please also tell us the
amounts of proceeds from the Pre-Closing Financing and Frequency Net Cash that are
anticipated to be allocated to each of these programs. Alternatively, please remove these
programs from the pipeline chart.
Korro Bio's Strategy, page 19
3.We note your response to prior comment 16 and revised disclosure. Please revise here and
on page 289 to provide the basis for your statements that Korro Bio has “position as a
leader” in RNA editing.
Background of the Merger, page 156
4.We note your response to prior comment 19 and revised disclosure. Please revise further
to disclose why the Frequency Board modified its position regarding the valuation of
Korro Bio and Frequency's equity premium. Alternatively, please advise.
Financial Analyses, page 177
5.We note your response to prior comment 22 and re-issue in part. Please disclose the stage
of development of each company presented in the comparable company analysis. Please
also present the estimated enterprise value for each selected company in the comparable
company analysis and disclose whether TD Cowen applied any discount factor to
companies at a more advanced stage of development than Korro Bio. You may state that
individual estimated enterprise values of each selected company were not independently
determinative or utilized in deriving the results of TD Cowen's selected publicly traded
companies analysis.
6.We note your response to prior comment 23. Please revise to disclose whether TD
Cowen's DCF analysis incorporated the possibility that Korro Bio's products are not
approved and/or Korro Bio does not achieve profitability.
Certain Unaudited Financial Projections for Korro Bio, page 179
7.We note your response to prior comment 24 and re-issue. Please revise to disclose the
extent to which the Frequency Board considered the Korro Bio Projections in making its
decision to approve the Merger. To the extent the Frequency Board considered the Korro
Bio Projections, please disclose whether the Frequency Board determined that the time
period and revenue figures presented in the projections were reasonable and, if so, the
reasons underlying these determinations.
FirstName LastNameDavid Lucchino
Comapany NameFrequency Therapeutics, Inc.
September 15, 2023 Page 3
FirstName LastName
David Lucchino
Frequency Therapeutics, Inc.
September 15, 2023
Page 3
Key Advantages of Oligonucleotide-Based ADAR-Mediated RNA Editing as a Therapeutic
Modality, page 292
8.We note your response to prior comment 29 and re-issue. We note your disclosure in the
graphic that oligo-based RNA editing has precedented delivery, tolerability and
manufacturing as well as multiple approved products. Please revise the graphic
to reconcile these claims with your statements in Risk Factors that Korro Bio is uncertain
how it will deliver product candidates to target tissues, RNA editing is a novel technology
that has not yet been validated for human therapeutic use, Korro Bio is not aware of
clinical trials being completed by third parties using RNA editing or similar technologies,
regulators have not established definitive guidelines for oligonucleotide drugs and no gene
editing therapeutic product has been approved in the U.S. or Europe.
Patent Portfolio, page 318
9.We note your response to prior comment 32 and re-issue in part. Please revise to disclose
for each material patent and patent application the subject matter to which such patents or
patent applications relate and the type of patent protection. In your revisions, please
discuss the patent protection for your lead product candidate(s).
You may contact Sasha Parikh at 202-551-3627 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Cindy Polynice at 202-551-8707 or Alan Campbell at 202-551-4224 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Jennifer Yoon, Esq.
2023-08-31 - CORRESP - Korro Bio, Inc.
CORRESP
1
filename1.htm
CORRESP
200 Clarendon Street
Boston,
Massachusetts 02116
Tel: +1.617.948.6000 Fax: +1.617.948.6001
www.lw.com
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August 31, 2023
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VIA EDGAR DELIVERY
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United States Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549-6010
Attention:
Cindy Polynice
Alan Campbell
Sasha Parikh
Mary Mast
Re:
Frequency Therapeutics, Inc.
Registration Statement on Form S-4
Filed July 27, 2023
File No. 333-273490
Ladies and Gentlemen:
On behalf of Frequency
Therapeutics, Inc., a Delaware corporation (the “Company”), we are providing this letter in response to comments received from the staff (the “Staff”) of the Securities and Exchange Commission (the
“Commission”) by letter dated August 23, 2023 (the “Comment Letter”) with respect to the Company’s Registration Statement on Form S-4, as filed on
July 27, 2023 (the “Registration Statement”).
In connection with this letter responding to the Comment
Letter the Company is concurrently filing Amendment No. 1 to the Company’s Registration Statement on Form S-4 (“Amendment No. 1”), which
reflects certain revisions to the Registration Statement in response to the Comment Letter as well as certain other changes.
For ease of
review, we have set forth below each of the numbered comments of the Comment Letter in bold type, followed by the Company’s responses thereto. Unless otherwise indicated, capitalized terms used herein have the meanings assigned to them in
Amendment No. 1 and all references to page numbers in such responses are to page numbers in Amendment No. 1.
August 31, 2023
Page 2
Registration Statement on Form S-4 filed July 27,
2023
Questions and Answers, page 2
1.
Please revise this section, where appropriate, as well as the Prospectus Summary, to disclose
Frequency’s net cash as of the most recent practicable date and to describe and quantify the factors that could affect Frequency’s net cash between this date and the closing date of the Merger.
Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 2 and 19 of Amendment
No. 1.
2.
Please revise this section, where appropriate, to briefly and clearly reflect your disclosure elsewhere in
the proxy statement/prospectus that the combined company will pursue the business of Korro Bio while attempting to sell the assets related to Frequency’s current business.
Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on page 2 of Amendment
No. 1.
3.
Please revise this section, where appropriate, to include the ownership of the combined company on a
fully-diluted basis.
Response: The Company respectfully acknowledges the Staff’s comment and has revised
the disclosure on page 2 of Amendment No. 1.
4.
Please revise this section, where appropriate, as well as the Prospectus Summary, to disclose the material
terms of the Pre-Closing Financing.
Response: The Company
respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 5 and 27 of Amendment No. 1.
Q: What are the CVRs
being issued to Frequency stockholders?, page 4
5.
Please revise the response to this question, as well as your disclosure on page 214, to disclose the fees
payable to the Rights Agent, when those fees will be paid and the party responsible for paying the fees.
Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 5 and 217 of Amendment
No. 1.
Prospectus Summary
Korro
Bio, Inc., page 13
6.
Your discussion of Korro Bio should present a balanced view of the company and its current stage of
development. Please revise your Prospectus Summary to include a more balanced discussion of Korro Bio. Your discussion of Korro Bio’s strengths and benefits
2
August 31, 2023
Page 3
should be balanced with equally prominent disclosure of weaknesses and challenges. By way of example only:
•
Reflect your disclosure on page 100 that the risk of failure of Korro Bio’s programs is high.
•
Reflect your disclosure on page 101 that Korro Bio is uncertain regarding the delivery of product candidates
to target tissues, the level of editing efficiency required for disease impact, its ability to achieve pharmacological activity in humans and the safety of its edits.
•
Clarify that it will be “many years” before Korro Bio commercializes a product candidate, if ever.
•
Reflect your disclosure on pages 103 and 116 that RNA editing is a novel technology that is not yet clinically
validated for human therapeutic use, Korro Bio is not aware of any clinical trials for safety or efficacy having been completed by any third party using RNA editing and that no gene editing therapeutic product has been approved in the U.S. or
Europe.
•
Reflect your disclosure on page 108 that the feasibility of developing product candidates using Korro
Bio’s approach is preliminary and limited.
•
Reflect your disclosure on page 115 that regulators have not yet established any definitive guidelines related
to overall development considerations for oligonucleotide drugs.
Response: The Company respectfully
acknowledges the Staff’s comment and has revised the disclosure on pages 15, 17, 18, 285, 287, 288, 289, 291, 293, 296, 300, 316, and 352 of Amendment No. 1.
7.
We note your statements regarding Korro Bio’s performance (e.g. Korro Bio’s programs “harness
the body’s natural RNA editing process to effect a precise yet transient single base edit”, “Korro Bio can edit the transcriptome with high efficiency and specificity”, etc.). Please revise throughout this section and the section
titled “Korro Bio’s Business” to clarify, if true, that the performance claims related to Korro Bio and its technology have only been observed in preclinical studies and that Korro Bio has yet to submit an IND to the FDA or commence a
clinical trial. Your clarifying disclosure should be equally as prominent as the performance claims.
Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 19 and 289 of Amendment
No. 1.
3
August 31, 2023
Page 4
8.
We note in your disclosure you state “Korro Bio’s AATD product candidate is a proprietary
oligonucleotide that utilizes an established lipid nanoparticle, or LNP, based delivery system administered intravenously to transiently restore production of normal A1AT in liver hepatocytes.” Please revise to disclose whether this product
candidate delivery system has been finalized and to reflect your disclosure on page 109 that LNPs have not been clinically proven to deliver oligonucleotides for RNA editing.
Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 17, 287, and 296 of
Amendment No. 1.
9.
We note your references here and throughout to Korro Bio’s “life changing” medicines and
claims that Korro Bio’s product candidates have the potential to “establish a new standard of care.” These characterizations appears to be premature given Korro Bio’s current stage of development. Please remove them.
Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on
pages 15, 17, 285, 287, 289, 299 and 350 of Amendment No. 1.
10.
Please revise here and throughout to provide the basis for your claim that Korro Bio has assembled the
“preeminent suite of technologies and capabilities” to build its OPERA platform.
Response: The
Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 15, 285 and 293 of Amendment No. 1.
11.
Please revise here and throughout to provide the basis for your claim that Korro Bio’s approach can
repair pathogenic SNVs, engineer de novo SNVs and change amino acids on proteins to endow them with desired properties while preserving their broader functional capabilities.
Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 16, 286 and 350 of
Amendment No. 1 to indicate that Korro Bio’s AATD program and Parkinson’s Disease program support the claim that Korro Bio’s approach can repair pathogenic SNVs, and Korro Bio’s sAH, ALS and Pain programs can engineer de
novo SNVs and change amino acids on proteins to endow them with desired properties while preserving their broader functional capabilities.
Supplementally, the Company advises the Staff that SNVs have been implicated in a number of diseases to affect the function of genes and their
associated downstream biochemical pathways. These diseases include AATD, sAH, ALS and subsets of pain. Specifically, the pathogenicity of AATD is caused by a G-to-A
mutation at the E342 location in the SERPINA1 gene. This mutation can lead to Z-A1AT in circulation (as disclosed on pages 17, 287-288, 297, and 299-302 of Amendment No. 1). Korro Bio has conducted preclinical studies in the PiZ mouse model (a humanized mouse model that expresses the human SERPINA1 gene), where, using its product candidates, has
demonstrated that it could repair the SNV and create a normal variant of the protein (M-A1AT) that could be detected in circulation (as disclosed in Figure 14 and on pages
305-306 of Amendment No. 1). Moreover, Korro Bio has shown the level of repaired normal M-A1AT subsequently expressed reduced liver aggregates found to be causal
for the disease (as disclosed in Figure 15 and on pages 306-307 of Amendment No. 1).
4
August 31, 2023
Page 5
The Company further supplementally advises the Staff that Korro Bio’s ability to
engineer de novo SNVs is exemplified by its sAH program. As disclosed in Figures 20 and 21 and on pages 311-312 of Amendment No. 1, Korro Bio has created a de novo mutation in RNA encoding a transcription factor present intracellularly
within liver cells. As disclosed, Korro Bio has demonstrated that by selectively modifying a single amino acid—a de novo mutation – it created a protein variant that:
•
disrupts the binding of a transcription factor with its inhibitor, preventing the degradation of that
transcription factor (Figure 20 on page 311 of Amendment No. 1),
•
despite not binding to the inhibitor, the transcription factor is still able to increase expression of downstream
genes (Figures 21 and 22 on page 312 of Amendment No. 1), and
•
demonstrates activity in preclinical models of sAH (Figure 23 on page 313 of Amendment No. 1).
Korro Bio’s Pipeline, page 15
12.
Please revise your pipeline chart here and on page 284 to ensure that the Phase 1, Phase 2 and Phase 3
columns are at least as wide as each of the other columns in the chart.
Response: The Company respectfully
acknowledges the Staff’s comment and has revised the disclosure on pages 17, 287 and 296 of Amendment No. 1.
13.
Your disclosure indicates that Korro Bio will need to complete additional preclinical work before it submits
an IND for its AATD product candidate. Please shorten the AATD pipeline arrow here and on page 284 accordingly.
Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 17, 287 and 296 of
Amendment No. 1.
14.
We note that you have included multiple rows in your pipeline chart for programs that are minimally
discussed in the prospectus and for which Korro Bio has yet to identify a product candidate. Please remove these programs from the chart. Alternatively, please provide us with an analysis as to why each of these programs is sufficiently material to
the business of the combined company as to merit inclusion in the pipeline chart.
Response: The Company
respectfully acknowledges the Staff’s comment and has revised the pipeline chart on pages 17, 287 and 296 of Amendment No. 1 to remove one of the undisclosed targets from the graphic. However, the Company believes that the remaining
indications are important to include in Korro Bio’s pipeline table because they support the potential breadth and versatility of Korro Bio’s RNA editing technology and OPERA platform. The Company believes the strength of Korro Bio’s
RNA editing technology and OPERA platform is the potential ability to address a broad range of rare and common indications and considers these programs taken together as material. The Company has also achieved preclinical proof-of-concept across each of these indications and has added the corresponding data in the proxy statement/prospectus on pages
310-316 of Amendment No. 1.
5
August 31, 2023
Page 6
Korro Bio’s Strategy, page 17
15.
We note your statement that Korro Bio intends to “rapidly” advance its AATD product candidate into
the clinic. Please revise this statement here and on page 286 as well as any similar disclosure to remove any implication that Korro Bio will be successful in developing its product candidate in a “rapid” or accelerated manner as such
statements are speculative.
Response: The Company respectfully acknowledges the Staff’s comment and has
revised the disclosure on pages 19, 104, 289-290, and 295 of Amendment No. 1.
16.
Please revise here and on page 286 to provide the basis for your statements that Korro Bio has a
“leadership position” in RNA editing and genetic medicines.
Response: The Company respectfully
acknowledges the Staff’s comment and has revised the disclosure on pages 19, 289 and 290 of Amendment No. 1.
Background of the Merger,
page 153
17.
Please revise this section to describe the negotiations related to the
Pre-Closing Financing.
Response: The Company respectfully
acknowledges the Staff’s comment and has revised the disclosure on pages 165-166 and 169 of Amendment No. 1.
18.
Your disclosure elsewhere in the prospectus indicates that Korro Bio sold additional shares of Series B-2 Preferred Stock during the quarter ended March 31, 2023. Please disclose the valuation ascribed to Korro Bio in this financing and disclose whether Frequency’s board of directors considered this
valuation in its evaluation of the Merger. To the extent that Frequency’s board did not consider this valuation, please explain why.
Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 158, 160 and 168 of
Amendment No. 1.
19.
Your disclosure throughout this section indicates that the Frequency Board believed that Korro Bio’s
valuation should be lower and that it directed TD Cowen to inform J.P. Morgan that an equity premium for Frequency below $20.7 million would not be acceptable. However, the final terms of the transaction appear to contain a valuation of Korro
Bio that is higher than the initial valuations reviewed by Frequency’s board and a Frequency equity premium that is capped at $15.0 million unless Frequency’s Net Cash exceeds $25.0 million and could be as low as
$12.5 million. Please revise this section to disclose why the Frequency Board modified its position on these issues. Alternatively, please advise.
Response: The Company respectfully acknowledges the Staff’s comment and has revised the disclosure on pages 167 and 168 of
Amendment No. 1.
6
August 31, 2023
Page 7
20.
Your disclosure indicates that on July 11, 2023, the parties agreed to a sliding equity premium scale
for Frequency which would apply a $12.5 million to $20.0 million premium, depending on Frequency’s level of net cash. However, this sliding scale does not appear to match the terms of the definition of Frequency Equity Value on page
192. Please revise your disclosure. Alternatively, please advise.
Response: The Company respectfully
acknowledges the Staff’s comment and has rev
2023-08-24 - UPLOAD - Korro Bio, Inc.
United States securities and exchange commission logo
August 23, 2023
David Lucchino
President and Chief Executive Officer
Frequency Therapeutics, Inc.
75 Hayden Avenue, Suite 300
Lexington, MA 02421
Re:Frequency Therapeutics, Inc.
Registration Statement on Form S-4
Filed July 27, 2023
File No. 333-273490
Dear David Lucchino:
We have reviewed your 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.
Registration Statement on Form S-4 filed July 27, 2023
Questions and Answers, page 2
1.Please revise this section, where appropriate, as well as the Prospectus Summary, to
disclose Frequency’s net cash as of the most recent practicable date and to describe and
quantify the factors that could affect Frequency’s net cash between this date and the
closing date of the Merger.
2.Please revise this section, where appropriate, to briefly and clearly reflect your disclosure
elsewhere in the proxy statement/prospectus that the combined company will pursue the
business of Korro Bio while attempting to sell the assets related to Frequency’s current
business.
3.Please revise this section, where appropriate, to include the ownership of the combined
FirstName LastNameDavid Lucchino
Comapany NameFrequency Therapeutics, Inc.
August 23, 2023 Page 2
FirstName LastNameDavid Lucchino
Frequency Therapeutics, Inc.
August 23, 2023
Page 2
company on a fully-diluted basis.
4.Please revise this section, where appropriate, as well as the Prospectus Summary, to
disclose the material terms of the Pre-Closing Financing.
Q: What are the CVRs being issued to Frequency stockholders?, page 4
5.Please revise the response to this question, as well as your disclosure on page 214, to
disclose the fees payable to the Rights Agent, when those fees will be paid and the party
responsible for paying the fees.
Prospectus Summary
Korro Bio, Inc., page 13
6.Your discussion of Korro Bio should present a balanced view of the company and its
current stage of development. Please revise your Prospectus Summary to include a more
balanced discussion of Korro Bio. Your discussion of Korro Bio’s strengths and benefits
should be balanced with equally prominent disclosure of weaknesses and challenges. By
way of example only:
•Reflect your disclosure on page 100 that the risk of failure of Korro Bio’s programs is
high.
•Reflect your disclosure on page 101 that Korro Bio is uncertain regarding the
delivery of product candidates to target tissues, the level of editing efficiency
required for disease impact, its ability to achieve pharmacological activity in humans
and the safety of its edits.
•Clarify that it will be “many years” before Korro Bio commercializes a product
candidate, if ever.
•Reflect your disclosure on pages 103 and 116 that RNA editing is a novel technology
that is not yet clinically validated for human therapeutic use, Korro Bio is not aware
of any clinical trials for safety or efficacy having been completed by any third party
using RNA editing and that no gene editing therapeutic product has been approved in
the U.S. or Europe.
•Reflect your disclosure on page 108 that the feasibility of developing product
candidates using Korro Bio’s approach is preliminary and limited.
•Reflect your disclosure on page 115 that regulators have not yet established any
definitive guidelines related to overall development considerations for
oligonucleotide drugs.
7.We note your statements regarding Korro Bio’s performance (e.g. Korro Bio’s programs
“harness the body’s natural RNA editing process to effect a precise yet transient single
base edit”, “Korro Bio can edit the transcriptome with high efficiency and specificity”,
etc.). Please revise throughout this section and the section titled “Korro Bio’s Business” to
clarify, if true, that the performance claims related to Korro Bio and its technology have
only been observed in preclinical studies and that Korro Bio has yet to submit an IND to
FirstName LastNameDavid Lucchino
Comapany NameFrequency Therapeutics, Inc.
August 23, 2023 Page 3
FirstName LastNameDavid Lucchino
Frequency Therapeutics, Inc.
August 23, 2023
Page 3
the FDA or commence a clinical trial. Your clarifying disclosure should be equally as
prominent as the performance claims.
8.We note in your disclosure you state "Korro Bio’s AATD product candidate is a
proprietary oligonucleotide that utilizes an established lipid nanoparticle, or LNP, based
delivery system administered intravenously to transiently restore production of normal
A1AT in liver hepatocytes." Please revise to disclose whether this product candidate
delivery system has been finalized and to reflect your disclosure on page 109 that LNPs
have not been clinically proven to deliver oligonucleotides for RNA editing.
9.We note your references here and throughout to Korro Bio’s “life changing” medicines
and claims that Korro Bio’s product candidates have the potential to “establish a new
standard of care.” These characterizations appears to be premature given Korro Bio’s
current stage of development. Please remove them.
10.Please revise here and throughout to provide the basis for your claim that Korro Bio has
assembled the “preeminent suite of technologies and capabilities” to build its OPERA
platform.
11.Please revise here and throughout to provide the basis for your claim that Korro Bio’s
approach can repair pathogenic SNVs, engineer de novo SNVs and change amino acids on
proteins to endow them with desired properties while preserving their broader functional
capabilities.
Korro Bio's Pipeline, page 15
12.Please revise your pipeline chart here and on page 284 to ensure that the Phase 1, Phase 2
and Phase 3 columns are at least as wide as each of the other columns in the chart.
13.Your disclosure indicates that Korro Bio will need to complete additional preclinical work
before it submits an IND for its AATD product candidate. Please shorten the AATD
pipeline arrow here and on page 284 accordingly.
14.We note that you have included multiple rows in your pipeline chart for programs that are
minimally discussed in the prospectus and for which Korro Bio has yet to identify a
product candidate. Please remove these programs from the chart. Alternatively, please
provide us with an analysis as to why each of these programs is sufficiently material to the
business of the combined company as to merit inclusion in the pipeline chart.
Korro Bio's Strategy, page 17
15.We note your statement that Korro Bio intends to “rapidly” advance its AATD product
candidate into the clinic. Please revise this statement here and on page 286 as well as any
similar disclosure to remove any implication that Korro Bio will be successful in
developing its product candidate in a “rapid” or accelerated manner as such statements are
speculative.
16.Please revise here and on page 286 to provide the basis for your statements that Korro Bio
FirstName LastNameDavid Lucchino
Comapany NameFrequency Therapeutics, Inc.
August 23, 2023 Page 4
FirstName LastNameDavid Lucchino
Frequency Therapeutics, Inc.
August 23, 2023
Page 4
has a “leadership position” in RNA editing and genetic medicines.
Background of the Merger, page 153
17.Please revise this section to describe the negotiations related to the Pre-Closing Financing.
18.Your disclosure elsewhere in the prospectus indicates that Korro Bio sold additional
shares of Series B-2 Preferred Stock during the quarter ended March 31, 2023. Please
disclose the valuation ascribed to Korro Bio in this financing and disclose whether
Frequency’s board of directors considered this valuation in its evaluation of the Merger.
To the extent that Frequency’s board did not consider this valuation, please explain why.
19.Your disclosure throughout this section indicates that the Frequency Board believed that
Korro Bio’s valuation should be lower and that it directed TD Cowen to inform J.P.
Morgan that an equity premium for Frequency below $20.7 million would not be
acceptable. However, the final terms of the transaction appear to contain a valuation of
Korro Bio that is higher than the initial valuations reviewed by Frequency’s board and a
Frequency equity premium that is capped at $15.0 million unless Frequency’s Net Cash
exceeds $25.0 million and could be as low as $12.5 million. Please revise this section to
disclose why the Frequency Board modified its position on these issues. Alternatively,
please advise.
20.Your disclosure indicates that on July 11, 2023, the parties agreed to a sliding equity
premium scale for Frequency which would apply a $12.5 million to $20.0 million
premium, depending on Frequency’s level of net cash. However, this sliding scale does
not appear to match the terms of the definition of Frequency Equity Value on page 192.
Please revise your disclosure. Alternatively, please advise.
21.Please revise this section, as well as your disclosure on page 20, to disclose why the
Frequency Board did not retain a third-party financial advisor who had not been
previously involved in the transaction to provide a fairness opinion.
Financial Analyses, page 174
22.Please revise your disclosure regarding the publicly traded companies analysis as follows:
•Disclose in more detail how TD Cowen identified each comparable company and
why these companies were deemed to be “relevant for the purposes of analysis.”
•Disclose the stage of development of each company in the analysis as well as each
company’s estimated enterprise value. To the extent that clinical-stage companies are
included in the analysis, please explain why TD Cowen included companies that are
at a more advanced stage of development than Korro Bio and whether TD Cowen
applied any discount factor to these companies.
23.Please revise your disclosure regarding TD Cowen’s DCF analysis to disclose why TD
Cowen believed that an analysis of the cash flows over 22 years was reasonable.
FirstName LastNameDavid Lucchino
Comapany NameFrequency Therapeutics, Inc.
August 23, 2023 Page 5
FirstName LastNameDavid Lucchino
Frequency Therapeutics, Inc.
August 23, 2023
Page 5
Certain Unaudited Financial Projections for Korro Bio, page 176
24.Please revise here and/or on page 165, as appropriate, to disclose the extent to which the
Frequency Board considered the Korro Bio Projections in making its decision to approve
the Merger. To the extent the Frequency Board considered the Korro Bio Projections,
please disclose whether the Frequency Board determined that the time period and revenue
figures presented in the projections were reasonable and, if so, the reasons underlying
these determinations.
25.Please revise to discuss the assumptions underlying the projections with more granularity.
For example, disclose whether the projections consider market competition for Korro
Bio’s product candidates and whether the projections incorporate any possibility of Korro
Bio’s product candidates failing to obtain marketing approval, market acceptance or
insurance coverage.
26.Please disclose and explain the bases for and the nature of the material assumptions that
underlie the line items presented in the financial projections. Please ensure the level of
detail provided is sufficient enough for an investor to evaluate and understand the
reasonableness of the assumptions, uncertainties and/or contingencies underlying the
projections as well as the inherent limitations on the reliability of projections in order to
make informed investment decisions. Please specifically address the growth rates as well
as identify the material product revenue streams underlying these projections.
27.We note your disclaimer that the Korro Bio Projections will not be updated even in the
event that any or all of the assumptions underlying such prospective financial information
are no longer appropriate. This disclaimer does not appear to be appropriate. Please
remove it.
Korro Bio's Business, page 282
28.Please revise this section to describe the material terms of Korro Bio’s agreement with
Genevant and file the agreement as an exhibit to your registration statement.
Key Advantages of Oligonucleotide-Based ADAR-Mediated RNA Editing as a Therapeutic
Modality, page 288
29.We note your disclosure in the graphic that oligo-based RNA editing has precedented
delivery, tolerability and manufacturing as well as multiple approved products. Please
reconcile these claims with your statements in Risk Factors that Korro Bio is uncertain
how it will deliver product candidates to target tissues, RNA editing is a novel technology
that has not yet been validated for human therapeutic use, Korro Bio is not aware of
clinical trials being completed by third parties using RNA editing or similar technologies,
regulators have not established definitive guidelines for oligonucleotide drugs and no gene
editing therapeutic product has been approved in the U.S. or Europe. Similarly revise the
bullets at the bottom of page 289.
FirstName LastNameDavid Lucchino
Comapany NameFrequency Therapeutics, Inc.
August 23, 2023 Page 6
FirstName LastName
David Lucchino
Frequency Therapeutics, Inc.
August 23, 2023
Page 6
Fit-for-purpose delivery, page 292
30.Please revise this bullet to clarify whether Korro Bio has tested any of these delivery
technologies for its product candidates and to clarify whether any approved RNA editing
drugs utilize these technologies.
Korro Bio's Approach to Overcome the Limitations: Transiently Correcting the SERPINA1
Variant on RNA, page 300
31.Please remove Figure 12 as the claims in this graphic appear to be premature given Korro
Bio’s current stage of development.
Patent Portfolio, page 313
32.Please revise to disclose for each material patent and patent application the subject matter
to which such patents or patent applications relate, the expiration date, the type of patent
protection and applicable jurisdictions.
Principal Stockholders of the Combined Company, page 423
33.Please revise to disclose the natural persons who hold voting and/or dispositive power
over the shares held by each of the institutions disclosed in the beneficial ownership table.
Korro Bio, Inc.
Notes to Condensed Consolidated Financial Statements
Note 10. Genevant Agreement, page F-96
34.Please revise your disclosure in the filing to disaggregate the aggregate total of $40.5
million potential payments to separately quantify payments by clinical, regulatory and
commercial milestones.
Exhibits
35.Please file the offer letter with Dr. Aiyar and the employment agreement with Mr.
Agarwal as exhibits to your registration statement.
FirstName LastNameDavid Lucchino
Comapany NameFrequency Therapeutics, Inc.
August 23, 2023 Page 7
FirstName LastName
David Lucchino
Frequency Therapeutics, Inc.
August 23, 2023
Page 7
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.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
You may contact Sasha Parikh at 202-551-3627 or Mary Mast at 202-551-3613 if you
have questions regarding comments on the financial statements and related matters. Please
contact Cindy Polynice at 202-551-8707 or Alan Campbell at 202-551-4224 with any other
questions.
Sincerely,
Division of Cor
2020-11-20 - CORRESP - Korro Bio, Inc.
CORRESP 1 filename1.htm CORRESP Frequency Therapeutics, Inc. 19 Presidential Way, 2nd Floor Woburn, MA 01801 November 20, 2020 VIA EDGAR TRANSMISSION Securities and Exchange Commission Division of Corporation Finance Mail Stop 4720 100 F Street, N.E. Washington, D.C. 20549 Attention: Tim Buchmiller Re: FREQUENCY THERAPEUTICS, INC. Registration Statement on Form S-3 (Registration No. 333-250099) Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, we hereby request acceleration of the effective date of the Registration Statement on Form S-3 (Registration No. 333-250099) (the “Registration Statement”) of Frequency Therapeutics, Inc. (the “Company”). We respectfully request that the Registration Statement become effective as of 4:00 p.m., Eastern Time, on November 24, 2020, or at such later time as the Company or its counsel may orally request via telephone call to the staff. Please contact Nathan Ajiashvili of Latham & Watkins LLP, counsel to the Company, at (212) 906-2916, or in his absence, Jennifer Yoon at (617) 880-4540, to provide notice of effectiveness, or if you have any other questions or concerns regarding this matter. Very truly yours, FREQUENCY THERAPEUTICS, INC. By: /s/ Michael D. Bookman Name: Michael D. Bookman Title: Deputy General Counsel cc: David L. Lucchino., Frequency Therapeutics, Inc. John Chory, Esq., Latham & Watkins LLP Nathan Ajiashvili, Esq., Latham & Watkins LLP Jennifer A. Yoon, Esq., Latham & Watkins LLP
2020-11-19 - UPLOAD - Korro Bio, Inc.
United States securities and exchange commission logo
November 19, 2020
David L. Lucchino
President and Chief Executive Officer
Frequency Therapeutics, Inc.
19 Presidential Way, 2nd Floor
Woburn, MA 01801
Re:Frequency Therapeutics, Inc.
Registration Statement on Form S-3
Filed November 16, 2020
File No. 333-250099
Dear Mr. Lucchino:
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 Tim Buchmiller at (202) 551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Nathan Ajiashvili, Esq.
2020-09-01 - CORRESP - Korro Bio, Inc.
CORRESP 1 filename1.htm CORRESP September 1, 2020 VIA EDGAR TRANSMISSION Securities and Exchange Commission Division of Corporation Finance Mail Stop 3010 100 F Street, N.E. Washington, D.C. 20549 Attention: Mr. Tim Buchmiller Re: Frequency Therapeutics, Inc. Registration Statement on Form S-1 (Registration No. 333-248474) Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, we hereby request acceleration of the effective date of the Registration Statement on Form S-1 (Registration No. 333- 248474) (the “Registration Statement”) of Frequency Therapeutics, Inc. (the “Company”). We respectfully request that the Registration Statement become effective as of 4:30 p.m., Eastern Time, on September 3, 2020, or at such later time as the Company or its counsel may orally request via telephone call to the staff. Once the Registration Statement has been declared effective, please orally confirm that event with our counsel, Latham & Watkins LLP, by calling Nathan Ajiashvili at (212) 906-2916 or Jennifer Yoon at (617) 880-4540. If you have any questions regarding the foregoing, please do not hesitate to contact Nathan Ajiashvili at (212) 906-2916 or Jennifer Yoon at (617) 880-4540, of Latham & Watkins LLP. Thank you in advance for your consideration. Very truly yours, FREQUENCY THERAPEUTICS, INC. By: /s/ David L. Lucchino Name: David L. Lucchino Title: President and Chief Executive Officer cc: Michael Bookman, Frequency Therapeutics, Inc. Nathan Ajiashvili, Latham & Watkins LLP Jennifer Yoon, Latham & Watkins LLP
2020-09-01 - UPLOAD - Korro Bio, Inc.
United States securities and exchange commission logo
September 1, 2020
David L. Lucchino
President and Chief Executive Officer
Frequency Therapeutics, Inc.
19 Presidential Way, 2nd Floor
Woburn, MA 01801
Re:Frequency Therapeutics, Inc.
Registration Statement on Form S-1
Filed August 28, 2020
File No. 333-248474
Dear Mr. Lucchino:
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 Tim Buchmiller at (202) 551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: John Chory, Esq.
2019-09-30 - CORRESP - Korro Bio, Inc.
CORRESP 1 filename1.htm CORRESP September 30, 2019 Via EDGAR Transmission United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Mail Stop 4720 Washington, D.C. 20549 Attention: Donald Field Re: Frequency Therapeutics, Inc. Registration Statement on Form S-1 Filed September 6, 2019 Registration No. 333-233652 Dear Mr. Field: In accordance with Rule 461 of Regulation C of the General Rules and Regulations under the Securities Act of 1933, as amended, we hereby request the acceleration of the effective date of the above-referenced Registration Statement so that it will become effective on October 2, 2019, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, or at such later time as Frequency Therapeutics, Inc. (the “Company”) or its counsel may request via telephone call to the staff. Please contact Nathan Ajiashvili of Latham & Watkins LLP, counsel to the Company, at (212) 906-2916, or in his absence, Jennifer Yoon at (617) 880-4540, to provide notice of effectiveness, or if you have any other questions or concerns regarding this matter. Sincerely yours, Frequency Therapeutics, Inc. By: /s/ David L. Lucchino David L. Lucchino President and Chief Executive Officer cc: Nathan Ajiashvili, Esq. Jennifer A. Yoon, Esq.
2019-09-30 - CORRESP - Korro Bio, Inc.
CORRESP 1 filename1.htm CORRESP J.P. Morgan Securities LLC 383 Madison Avenue New York, New York 10179 Goldman Sachs & Co. LLC 200 West Street New York, New York 10282 Cowen and Company, LLC 599 Lexington Avenue New York, New York 10022 September 30, 2019 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Donald Field Re: Frequency Therapeutics, Inc. Registration Statement on Form S-1 (File No. 333-233652) 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 hereby join in the request of Frequency Therapeutics, Inc. (the “Company”) that the effective date of the above-referenced Registration Statement be accelerated so that it will be declared effective at 4:00 p.m., Washington, D.C. time, on October 2, 2019, or as soon thereafter as practicable, or at such later time as the Company or its counsel may request via telephone call to the staff. Pursuant to Rule 460 under the Act, we wish to advise you that we have effected the following distribution of the Company’s Preliminary Prospectus dated September 23, 2019: (i) Dates of distribution: September 23, 2019 through the date hereof. (ii) Number of prospectuses distributed: a total of approximately 3,449 copies of the prospectus were distributed to prospective underwriters, institutional investors, dealers and others. We have complied and will comply, and have been informed by the participating underwriters that they have complied and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. Very truly yours, J.P. MORGAN SECURITIES LLC GOLDMAN, SACHS & CO. LLC COWEN AND COMPANY, LLC As Representatives of the Underwriters By: J.P. MORGAN SECURITIES LLC By: /s/ David Ke Name: David Ke Title: Executive Director By: GOLDMAN SACHS & CO. LLC By: /s/ Lyla Bibi Name: Lyla Bibi Title: Managing Director By: COWEN AND COMPANY, LLC By: /s/ Bill Follis Name: Bill Follis Title: Managing Director
2019-09-13 - CORRESP - Korro Bio, Inc.
CORRESP 1 filename1.htm CORRESP 53rd at Third 885 Third Avenue New York, New York 10022-4834 Tel: +1.212.906.1200 Fax: +1.212.751.4864 www.lw.com FIRM / AFFILIATE OFFICES FOIA CONFIDENTIAL TREATMENT REQUEST UNDER 17 C.F.R. §200.83 The entity requesting confidential treatment is: Frequency Therapeutics, Inc. 19 Presidential Way, 2nd Floor Woburn, MA 01801 Beijing Boston Brussels Century City Chicago Dubai Düsseldorf Frankfurt Hamburg Hong Kong Houston London Los Angeles Madrid Milan Moscow Munich New York Orange County Paris Riyadh San Diego San Francisco Seoul Shanghai Silicon Valley Singapore Tokyo Washington, D.C. Certain confidential information in this letter has been omitted and provided separately to the Securities and Exchange Commission. Confidential treatment has been requested by Frequency Therapeutics, Inc. with respect to the omitted portions, which are identified in this letter by the mark “[***].” September 13, 2019 VIA EDGAR AND HAND DELIVERY CONFIDENTIAL U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Mail Stop 4720 Washington, D.C. 20549 Attention: Donald Field Dietrich King Andi Carpenter Sharon Blume Re: Frequency Therapeutics, Inc. | Anticipated Price Range and Share-Based Compensation | Registration Statement on Form S-1 (File No. 333-233652) September 13, 2019 Page 2 Dear Mr. Field: On behalf of Frequency Therapeutics, Inc. (the “Company”), we submit this letter to the staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”). The Company confidentially submitted a draft of the above-referenced Registration Statement (the “Registration Statement”) to the Commission on July 19, 2019, resubmitted the Registration Statement to the Commission on August 22, 2019, and subsequently filed the Registration Statement with the Commission on September 6, 2019. The purpose of this letter is to respond to an outstanding comment relating to share-based compensation that was provided to the Company in a letter from the Staff dated August 13, 2019. Because of the commercially sensitive nature of the information contained herein, this submission is accompanied by the Company’s request for confidential treatment of selected portions of this letter pursuant to Rule 83 of the Commission’s Rules on Information and Requests, 17 C.F.R. §200.83. A redacted letter has been filed on EDGAR, omitting the confidential information contained in the Letter. For the convenience of the Staff, we are providing to the Staff copies of this letter by hand delivery. In this letter, we have recited the prior comment from the Staff in italicized, bold type and have followed the comment with the Company’s response. 3. Once you have an estimated offering price or range, please explain to us the reasons for any differences between the recent valuations of your common stock and the estimated offering price. This information will help facilitate our review of your accounting for equity issuance including stock compensation and beneficial conversion features. Estimated Preliminary IPO Price Range The Company supplementally advises the Staff that, while not yet reflected in the Registration Statement, based on discussions with the Company’s board of directors (the “Board”) and reflecting input from the lead underwriters (the “Underwriters”) of the Company’s proposed initial public offering of its common stock (“IPO”), if the Company were to commence marketing of the IPO today, the Company presently anticipates that the estimated price range would be approximately $[***] per share to $[***] per share (the “Preliminary IPO Price Range”), with a midpoint of approximately $[***] per share (the “Preliminary Assumed IPO Price”), before giving effect to an anticipated reverse stock split. The Company advises the Staff that the final range to be included in a pre-effective amendment to the Registration Statement will include a price range of no more than $2.00, if the maximum price is $10.00 per share or less, or 20% of the high end of the range, if the maximum price is greater than $10.00 per share, unless otherwise approved by the Staff. The Company’s final range to be included in a pre-effective amendment to the Registration Statement remains under discussion between the Company and the Underwriters, and a bona fide price range will be included in an amendment to the Registration Statement prior to any distribution of the preliminary prospectus in connection with the Company’s road show. Summary of Recent Option Grants and Common Stock Valuation The estimated fair value of the Company’s common stock has been determined by the Board as of the date of each stock option grant or restricted stock award (“RSA”), with input from management after considering third-party valuations of the common stock, as well as the Board’s assessment of additional objective and subjective factors that it believed were relevant and which may have changed from the date of the most recent third-party valuation through the date of the grant. This valuation methodology has been applied as there has been no public market to date for the common stock of the Company. These third-party valuations were performed in accordance with the guidance outlined in the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation, and were prepared using a hybrid method, which is a probability-weighted expected return method (“PWERM”) where the equity value in one or more of the scenarios is calculated using an option pricing method (“OPM”). CONFIDENTIAL TREATMENT HAS BEEN REQUESTED BY FREQUENCY THERAPEUTICS, INC. September 13, 2019 Page 3 The Company’s most recent third-party valuations, which were used, in part, by the Board to determine the fair value of the Company’s common stock as of the grant date of each option and/or restricted stock award, considered a combination of the following three future-event scenarios: an IPO scenario, a sale scenario, and a liquidation scenario. The equity value of the Company in the IPO scenario and the sale scenario was determined using market approaches. The IPO scenario assumed that all shares of preferred stock would convert into shares of common stock and would no longer have the liquidation preferences and preferential rights attributable to the preferred stock as compared to the common stock prior to the IPO. Each valuation probability-weighted the future-event scenarios based on the Company’s assessment of its development pipeline and market conditions at that time. For the IPO scenario and the sale scenario, the Company then applied a discount for lack of marketability (“DLOM”), each determined by a put option analysis that considered the timing of each future-event scenario. Since July 1, 2018, equity awards were granted as follows at the exercise or sale price that the Board determined to be the fair value per share of the Company’s common stock on that date: Grant Date Type of award Number of Shares Subject to Award Granted Per Share Exercise Price of Options or Sale Price for RSAs Fair Value per Share of Common Stock on Grant Date December 5, 2018 Options 315,000 $ 0.26 $ 0.26 December 5, 2018 RSAs 50,000 $ 0.26 $ 0.26 April 17, 2019 Options 15,995,329 $ 0.50 $ 0.50 May 20, 2019 Options 1,000,000 $ 0.50 $ 0.50 August 2, 2019 Options 1,215,000 $ 1.11 $ 1.11 August 18, 2019 Options 1,250,000 $ 1.11 $ 1.11 September 11, 2019 Options 850,000 $ 1.58 $ 1.58 The Board’s determination of each fair value was based, in part, on the results of a third-party valuation of the Company’s common stock performed on October 31, 2018 (the “October 31, 2018 Valuation”), March 31, 2019 (the “March 31, 2019 Valuation”), July 19, 2019 (the “July 19, 2019 Valuation”), and September 6, 2019 (the “September 6, 2019 Valuation”). December 5, 2018 Option and Restricted Stock Grants. The Board determined that the fair value of the Company’s common stock was $0.26 per share as of December 5, 2018 based on input from management, the objective and subjective factors that it believed were relevant and the results of the October 31, 2018 Valuation. The October 31, 2018 Valuation was prepared taking into account the sale of shares of the Company’s Series B preferred stock to new and existing investors on October 17, 2018, at a price of $0.92 per share for total consideration of $40.0 million. In the October 31, 2018 Valuation, the independent third-party valuation specialist used a hybrid back-solve method considering three scenarios in a PWERM framework and using the OPM to allocate value in one of the scenarios. The scenarios CONFIDENTIAL TREATMENT HAS BEEN REQUESTED BY FREQUENCY THERAPEUTICS, INC. September 13, 2019 Page 4 included: a trade-sale scenario predicated on the Series B financing that transpired prior to the valuation date, an IPO scenario with reference to the arms’ length capital transaction, and a liquidation scenario. Under the hybrid method, the per share value calculated under the three scenarios are weighted based on expected exit outcomes and the quality of the information specific to each allocation methodology to arrive at a final estimated fair value per share of the common stock before a DLOM is applied. The October 31, 2018 Valuation (i) assigned a 75% probability of occurrence to the trade-sale scenario, with a 71% volatility rate and a 1.9-year weighted average estimated term applied within the OPM, then reflected a DLOM of 35%; and (ii) assigned a 5% probability of occurrence to the IPO scenario, with a 30% discount rate and a 1.0-year estimated term to an IPO event, then reflected a DLOM of 15%. The liquidation scenario was weighted at 20% with no value allocated to the common stock for this scenario. April 17, 2019 and May 20, 2019 Option Grants. The Board determined that the fair value of the Company’s common stock was $0.50 per share as of April 17, 2019 and May 20, 2019 based on input from management, the objective and subjective factors that it believed were relevant, and the results of the March 31, 2019 Valuation. In the March 31, 2019 Valuation, the independent third-party valuation specialist used a hybrid back-solve method considering three scenarios in a PWERM framework and using the OPM to allocate value in one of the scenarios. The scenarios included: a trade-sale scenario predicated on a projected future M&A transaction, an IPO scenario with reference to guideline IPO transactions, and a liquidation scenario. Under the hybrid method, the per share value calculated under the three scenarios are weighted based on expected exit outcomes and the quality of the information specific to each allocation methodology to arrive at a final estimated fair value per share of the common stock before a DLOM is applied. The March 31, 2019 Valuation (i) assigned a 70% probability of occurrence to the trade-sale scenario, with a 79% volatility rate and a 1.9-year weighted average estimated term applied within the OPM, then reflected a DLOM of 30%; and (ii) assigned a 20% probability of occurrence to the IPO scenario, with a 30% discount rate and a 0.7-year estimated term to an IPO event, then reflected a DLOM of 12.5%. The liquidation scenario was weighted at 10% with no value allocated to the common stock for this scenario. The March 31, 2019 Valuation also took into consideration clinical data from the unblinding of the Company’s Phase 1 clinical trial for its primary product candidate, FX-322, in late January 2019 as well as the signing of a letter of intent on March 28, 2019 with Astellas Pharma, Inc. (“Astellas”) for a corporate collaboration centered around FX-322. Further, it also reflects that the Company was actively seeking a lead investor for its Series C preferred stock crossover financing, did not execute a term sheet until May 21, 2019, and did not fill out the financing syndicate until some time thereafter. The closing of this crossover financing was contingent on the closing of the corporate partnership with Astellas. August 2, 2019 and August 18, 2019 Option Grants. The Board determined that the fair value of the Company’s common stock was $1.11 per share as of August 2, 2019 and August 18, 2019 based on input from management, the objective and subjective factors that it believed were relevant and the results of the July 19, 2019 Valuation. The July 19, 2019 Valuation was prepared taking into account the sale of shares of the Company’s Series C preferred stock to new and existing investors on July 17, 2019 at a price of $1.57 per share for total consideration of $62.0 million. In the July 19, 2019 Valuation, the independent third-party valuation specialist used a hybrid back-solve method considering two scenarios in a PWERM framework and using the OPM to allocate value in one of the scenarios. The scenarios included: a trade-sale scenario predicated on the Company’s Series C financing and an IPO scenario with reference to guideline IPO transactions. Under the hybrid method, the per share value calculated under the two scenarios are weighted based on expected exit outcomes and the quality of the information specific to each allocation methodology to arrive at a final estimated fair value per share of the common stock before a CONFIDENTIAL TREATMENT HAS BEEN REQUESTED BY FREQUENCY THERAPEUTICS, INC. September 13, 2019 Page 5 DLOM is applied. The July 19, 2019 Valuation (i) assigned a 40% probability of occurrence to the trade-sale scenario, with a 79% volatility rate and a 1.5-year weighted average estimated term applied within the OPM, then reflected a DLOM of 30%; and (ii) assigned a 60% probability of occurrence to the IPO scenario, with a 25% discount rate and a 0.2-year estimated term to an IPO event, then reflected a DLOM of 10%. The July 19, 2019 Valuation also took into consideration the execution of the corporate collaboration with Astellas on July 17, 2019 and the confidential submission of the Registration Statement on July 19, 2019. September 11, 2019 Option Grants. The Board determined that the fair value of the Company’s common stock was $1.58 per share as of September 11, 2019 based on input from management, the objective and subjective factors that it believed were relevant and the results of the September 6, 2019 Valuation. The September 6, 2019 Valuation was prepared taking into account the sale of shares of the Company’s Series C preferred stock to new and existing investors on July 17, 2019 at a price of $1.57 per share for total consideration of $62.0 million. In the September 6, 2019 Valuation, the independent third-party valuation specialist used a hybrid back-solve method considering two scenarios in a PWERM framework and using the OPM to allocate value in one of the scenarios. The scenarios included: a trade-sale scenario predicated on the Company’s Series C financing and an IPO scenario with reference to guideline IPO transactions. Under the hybrid method, the per share value calculated under the two scenarios are weighted based on expected exit outcomes and the quality of the information specific to each allocation methodology to arrive at a final estimated fair value per share of the common stock before a DLOM is applied. The September 6, 2019 Valuation (i) assigned a 15% probability of occurrence to the trade-sale scenario, with a 79% volatility rate and a 1.5-year weighted average estimated term applied within the OPM, then reflected a DLOM of 30%; and (ii) assigned a 85% probability of occurrence to the IPO scenario, with a 25% discount rate and a 0.24-year estimated term to an IPO event, then reflected a DLOM of 2.5%. The September 6, 2019 Valuation also took into consideration the execu
2019-09-06 - CORRESP - Korro Bio, Inc.
CORRESP 1 filename1.htm CORRESP 200 Clarendon Street Boston, Massachusetts 02116 Tel: +1.617.948.6000 Fax: +1.617.948.6001 www.lw.com FIRM / AFFILIATE OFFICES September 6, 2019 Beijing Boston Brussels Century City Chicago Dubai Düsseldorf Frankfurt Hamburg Hong Kong Houston London Los Angeles Madrid Milan Moscow Munich New York Orange County Paris Riyadh San Diego San Francisco Seoul Shanghai Silicon Valley Singapore Tokyo Washington, D.C. VIA EDGAR AND OVERNIGHT DELIVERY Division of Corporation Finance Office of Healthcare & Insurance United States Securities and Exchange Commission 100 F Street, N.E. Mail Stop 4720 Washington, D.C. 20549 Attn: Donald Field Re: Frequency Therapeutics, Inc. Draft Registration Statement on Form S-1 Submitted August 22, 2019 CIK 0001703647 Dear Mr. Field: On behalf of Frequency Therapeutics, Inc., a Delaware corporation (the “Company”), we are transmitting this letter in response to comments received from the staff (the “Staff”) of the Securities and Exchange Commission by letter dated September 4, 2019 with respect to the Company’s confidential Draft Registration Statement on Form S-1 submitted on August 22, 2019 (the “Draft Registration Statement”). This letter is being submitted together with the Company’s Registration Statement on Form S-1 (the “Registration Statement”), which has been revised to address various of the Staff’s comments. The bold and numbered paragraphs below correspond to the numbered paragraphs in the Staff’s letter and are followed by the Company’s responses. For the Staff’s convenience, we are also sending, by courier, copies of this letter and marked copies of the Registration Statement that reflect changes made to the Draft Registration Statement. September 6, 2019 Page 2 Impact and prevalence of hearing, page 99 1. We note your response to comment 4. Please revise the exhibit index to indicate that you will file a consent from Health Advances LLC pursuant to Rule 436 of the Securities Act. For guidance, please refer to Question 233.02 of our Securities Act Rules Compliance and Disclosure Interpretations, which are available on our website. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that the consent from Health Advances LLC has been filed as Exhibit 23.3 to the Registration Statement. Unaudited Consolidated Financial Statements as of June 30, 2018 and 2019 Consolidated Balance Sheets, page F-31 2. Please revise to reflect only the conversion of preferred stock existing at the latest balance sheet date in the pro forma information presented on the face of your historical financial statements. In this regard, while we do not object to the inclusion of other pro forma adjustments on your capitalization table, we believe that the pro forma presentation on the face of the historical statements should be limited to the impact of pro forma adjustments on financial instruments actually outstanding at the balance sheet date. Response: The Company respectfully acknowledges the Staff’s comment and advises the Staff that it has revised pages F-31 and F-36 in response to the Staff’s comment. Please do not hesitate to contact me at 212-906-2916 or Jennifer Yoon at 617-880-4540 with any questions or further comments you may have regarding this filing or if you wish to discuss the Company’s responses above. Sincerely, /s/ Nathan Ajiashvili Nathan Ajiashvili of LATHAM & WATKINS LLP cc: David L. Lucchino, Frequency Therapeutics, Inc. Michael D. Bookman, Frequency Therapeutics, Inc. Jennifer A. Yoon, Latham & Watkins LLP Arthur D. Robinson, Simpson Thacher & Bartlett LLP
2019-09-04 - UPLOAD - Korro Bio, Inc.
September 4, 2019
David L. Lucchino
Chief Executive Officer
Frequency Therapeutics, Inc.
19 Presidential Way, 2nd Floor
Woburn, MA 01801
Re:Frequency Therapeutics, Inc.
Amendment No. 1 to
Draft Registration Statement on Form S-1
Submitted August 22, 2019
CIK No. 0001703647
Dear Mr. Lucchino:
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
Impact and prevalence of hearing , page 99
1.We note your response to comment 4. Please revise the exhibit index to indicate that you
will file a consent from Health Advances LLC pursuant to Rule 436 of the Securities Act.
For guidance, please refer to Question 233.02 of our Securities Act Rules Compliance and
Disclosure Interpretations, which are available on our website.
FirstName LastNameDavid L. Lucchino
Comapany NameFrequency Therapeutics, Inc.
September 4, 2019 Page 2
FirstName LastName
David L. Lucchino
Frequency Therapeutics, Inc.
September 4, 2019
Page 2
Unaudited Consolidated Financial Statements as of June 30, 2018 and 2019
Consolidated Balance Sheets, page F-31
2.Please revise to reflect only the conversion of preferred stock existing at the latest balance
sheet date in the pro forma information presented on the face of your historical financial
statements. In this regard, while we do not object to the inclusion of other pro forma
adjustments on your capitalization table, we believe that the pro forma presentation on the
face of the historical statements should be limited to the impact of pro forma adjustments
on financial instruments actually outstanding at the balance sheet date.
You may contact Andi Carpenter at 202-551-3645 or Sharon Blume at 202-551-3474
if you have questions regarding comments on the financial statements and related matters.
Please contact Donald Field at 202-551-3680 or Dietrich King at 202-551-8071 with any
other questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2019-08-13 - UPLOAD - Korro Bio, Inc.
August 13, 2019
David L. Lucchino
Chief Executive Officer
Frequency Therapeutics, Inc.
19 Presidential Way, 2nd Floor
Woburn, MA 01801
Re:Frequency Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted July 19, 2019
CIK No. 0001703647
Dear Mr. Lucchino:
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
Implications of being an emerging growth company, page 5
1.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.
Use of proceeds, page 65
2.We note that the net proceeds will be used to fund the clinical development of FX-322 to
include your planned Phase 2a clinical trial. Please revise your disclosure to specify how
far in the clinical development you expect to reach with the net proceeds.
FirstName LastNameDavid L. Lucchino
Comapany NameFrequency Therapeutics, Inc.
August 13, 2019 Page 2
FirstName LastNameDavid L. Lucchino
Frequency Therapeutics, Inc.
August 13, 2019
Page 2
Management’s discussion and analysis of financial condition and results of operations
Critical accounting policies and use of estimates
Determination of fair value of common stock, page 88
3.Once you have an estimated offering price or range, please explain to us the reasons for
any differences between the recent valuations of your common stock and the estimated
offering price. This information will help facilitate our review of your accounting for
equity issuance including stock compensation and beneficial conversion features.
Impact and prevalence of hearing loss, page 96
4.We note that the prospectus includes information from a commissioned study. Please
identify the party who prepared the study and revise the exhibit index to indicate that you
will file a consent from such party pursuant to Rule 436 of the Securities Act.
Astellas Pharma, Inc., page 111
5.We note your disclosure that you may be entitled to double-digit royalties on any future
product sales in the licensed territory. Please revise your description of royalty rates to
provide a range that does not exceed ten percent.
Massachusetts Institute of Technology, page 111
6.We note your disclosure that you are required to pay certain annual license maintenance
fees. Please revise to disclose the general range of the annual license maintenance fees.
7.We note your disclosure that you are subject to certain development timeline obligations.
Please revise to disclose these development timeline obligations or, alternatively, advise
why such obligations are not material to the company. Please also revise the
Massachusetts Eye and Ear Infirmary and The Scripps Research Institute (California
Institute for Biomedical Research) sections on page 112 accordingly.
Massachusetts Eye and Ear Infirmary, page 112
8.We note your disclosure that you are required to pay certain annual license maintenance
fees and a minimum annual royalty payment after first commercial sale. Please revise to
disclose the general range of these fees and payments.
The Scripps Research Institute, page 113
9.We note your disclosure that you are required to make certain funding payments to
support Scripps's research activities. Please revise to disclose the general range of the
funding payments.
FirstName LastNameDavid L. Lucchino
Comapany NameFrequency Therapeutics, Inc.
August 13, 2019 Page 3
FirstName LastName
David L. Lucchino
Frequency Therapeutics, Inc.
August 13, 2019
Page 3
General
10.Please provide us mockups of any pages that include any additional pictures or graphics to
be presented, including any accompanying captions. Please keep in mind, in scheduling
your printing and distribution of the preliminary prospectus, that we may have comments
after our review of these materials.
You may contact Andi Carpenter at 202-551-3645 or Sharon Blume at 202-551-3474 if
you have questions regarding comments on the financial statements and related matters. Please
contact Donald Field at 202-551-3680 or Dietrich King at 202-551-8071 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
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