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Vor Biopharma Inc.
Response Received
1 company response(s)
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Vor Biopharma Inc.
Awaiting Response
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Vor Biopharma Inc.
Response Received
1 company response(s)
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Vor Biopharma Inc.
Response Received
1 company response(s)
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Vor Biopharma Inc.
Response Received
1 company response(s)
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Vor Biopharma Inc.
Response Received
1 company response(s)
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Company responded
2022-03-16
Vor Biopharma Inc.
Summary
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Vor Biopharma Inc.
Response Received
4 company response(s)
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Company responded
2021-01-21
Vor Biopharma Inc.
References: December 3, 2020
Summary
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SEC wrote to company
2021-01-27
Vor Biopharma Inc.
Summary
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Company responded
2021-02-01
Vor Biopharma Inc.
References: January 27, 2021
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Company responded
2021-02-02
Vor Biopharma Inc.
Summary
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Company responded
2021-02-02
Vor Biopharma Inc.
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Vor Biopharma Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2021-01-04
Vor Biopharma Inc.
Summary
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Company responded
2021-01-15
Vor Biopharma Inc.
References: January 4, 2021
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Vor Biopharma Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2020-12-04
Vor Biopharma Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-02-02 | Company Response | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2026-01-30 | SEC Comment Letter | Vor Biopharma Inc. | N/A | 333-293052 | Read Filing View |
| 2025-09-30 | SEC Comment Letter | Vor Biopharma Inc. | N/A | 333-290490 | Read Filing View |
| 2025-03-27 | Company Response | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2025-03-26 | SEC Comment Letter | Vor Biopharma Inc. | N/A | 333-285969 | Read Filing View |
| 2025-01-27 | Company Response | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2025-01-27 | SEC Comment Letter | Vor Biopharma Inc. | N/A | 333-284380 | Read Filing View |
| 2022-12-16 | Company Response | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2022-12-15 | SEC Comment Letter | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2022-03-16 | Company Response | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2022-03-16 | SEC Comment Letter | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2021-02-02 | Company Response | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2021-02-02 | Company Response | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2021-02-01 | Company Response | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2021-01-27 | SEC Comment Letter | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2021-01-21 | Company Response | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2021-01-15 | Company Response | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2021-01-04 | SEC Comment Letter | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2020-12-04 | SEC Comment Letter | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-01-30 | SEC Comment Letter | Vor Biopharma Inc. | N/A | 333-293052 | Read Filing View |
| 2025-09-30 | SEC Comment Letter | Vor Biopharma Inc. | N/A | 333-290490 | Read Filing View |
| 2025-03-26 | SEC Comment Letter | Vor Biopharma Inc. | N/A | 333-285969 | Read Filing View |
| 2025-01-27 | SEC Comment Letter | Vor Biopharma Inc. | N/A | 333-284380 | Read Filing View |
| 2022-12-15 | SEC Comment Letter | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2022-03-16 | SEC Comment Letter | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2021-01-27 | SEC Comment Letter | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2021-01-04 | SEC Comment Letter | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2020-12-04 | SEC Comment Letter | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-02-02 | Company Response | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2025-03-27 | Company Response | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2025-01-27 | Company Response | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2022-12-16 | Company Response | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2022-03-16 | Company Response | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2021-02-02 | Company Response | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2021-02-02 | Company Response | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2021-02-01 | Company Response | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2021-01-21 | Company Response | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
| 2021-01-15 | Company Response | Vor Biopharma Inc. | N/A | N/A | Read Filing View |
2026-02-02 - CORRESP - Vor Biopharma Inc.
CORRESP 1 filename1.htm CORRESP Vor Biopharma Inc. 500 Boylston Street, Suite 1350 Boston, MA 02116 February 2, 2026 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Daniel Crawford RE: Vor Biopharma Inc. Registration Statement on Form S-3 (File No. 333-293052) Request for Acceleration of Effective Date Requested Date: February 4, 2026 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “ Registrant ”) hereby requests that the Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-293052) (the “ Registration Statement ”) to become effective on February 4, 2026, at 4:00 p.m. Eastern Time, or as soon thereafter as is practicable. Once the Registration Statement has been declared effective, please orally confirm that event with Divakar Gupta of Cooley LLP, counsel to the Registrant, at (212) 479-6474, or in his absence, David Brinton at (202) 776-2989. Very truly yours, Vor Biopharma Inc. By: /s/ Sandy Mahatme Name: Sandy Mahatme Title: Chief Financial Officer
2026-01-30 - UPLOAD - Vor Biopharma Inc. File: 333-293052
January 30, 2026
Jean-Paul Kress, M.D.
President, Chief Executive Officer and Chairman of the Board
Vor Biopharma Inc.
500 Boylston Street, Suite 1350
Boston, MA 02116
Re:Vor Biopharma Inc.
Registration Statement on Form S-3
Filed January 29, 2026
File No. 333-293052
Dear Jean-Paul Kress M.D.:
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:Div Gupta, Esq.
2025-09-30 - UPLOAD - Vor Biopharma Inc. File: 333-290490
September 30, 2025
Jean-Paul Kress, M.D.
President and Chief Executive Officer
Vor Biopharma Inc.
500 Boylston Street, Suite 1350
Boston, Massachusetts 02116
Re:Vor Biopharma Inc.
Registration Statement on Form S-3
Filed September 24, 2025
File No. 333-290490
Dear Jean-Paul Kress M.D.:
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:Katie Kazem
2025-03-27 - CORRESP - Vor Biopharma Inc.
CORRESP 1 filename1.htm CORRESP V OR B IOPHARMA I NC . 100 Cambridgepark Drive, Suite 101 Cambridge, MA 02140 March 27, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Lauren Hamill Re: Vor Biopharma Inc. Registration Statement on Form S-3 (File No. 333- 285969) Request for Acceleration of Effective Date Requested Date: March 31, 2025 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “ Registrant ”) hereby requests that the Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333- 285969) (the “ Registration Statement ”) to become effective on March 31, 2025, at 4:00 p.m. Eastern Time, or as soon thereafter as is practicable. Once the Registration Statement has been declared effective, please orally confirm that event with Katie Kazem of Cooley LLP, counsel to the Registrant, at (703) 456-8043, or in her absence, Divakar Gupta at (212) 479-6474. Very truly yours, Vor Biopharma Inc. By: /s/ Robert Ang Robert Ang Chief Executive Officer
2025-03-26 - UPLOAD - Vor Biopharma Inc. File: 333-285969
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> March 26, 2025 Robert Ang Chief Executive Officer Vor Biopharma Inc. 100 Cambridgepark Drive Suite 101 Cambridge, MA 02140 Re: Vor Biopharma Inc. Registration Statement on Form S-3 Filed March 20, 2025 File No. 333-285969 Dear Robert Ang: 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 Lauren Hamill at 303-844-1008 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Katie Kazem </TEXT> </DOCUMENT>
2025-01-27 - CORRESP - Vor Biopharma Inc.
CORRESP 1 filename1.htm CORRESP VOR BIOPHARMA INC. 100 Cambridgepark Drive, Suite 101 Cambridge, MA 02140 January 27, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Alan Campbell Re: Vor Biopharma Inc. Registration Statement on Form S-3 (File No. 333-284380) Request for Acceleration of Effective Date Requested Date: January 29, 2025 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement on Form S-3 (File No. 333-284380) (the “Registration Statement”) to become effective on January 29, 2025, at 4:00 p.m. Eastern Time, or as soon thereafter as is practicable. Once the Registration Statement has been declared effective, please orally confirm that event with Katie Kazem of Cooley LLP, counsel to the Registrant, at (703) 456-8043, or in her absence, Divakar Gupta at (212) 479-6474. Very truly yours, Vor Biopharma Inc. By: /s/ Robert Ang Robert Ang Chief Executive Officer
2025-01-27 - UPLOAD - Vor Biopharma Inc. File: 333-284380
January 27, 2025
Robert Ang
President and Chief Executive Officer
Vor Biopharma Inc.
100 Cambridgepark Drive, Suite 101
Cambridge, MA 02140
Re:Vor Biopharma Inc.
Registration Statement on Form S-3
Filed January 21, 2025
File No. 333-284380
Dear Robert Ang:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Alan Campbell at 202-551-4224 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc:Katie Kazem
2022-12-16 - CORRESP - Vor Biopharma Inc.
CORRESP
1
filename1.htm
CORRESP
VOR BIOPHARMA INC.
100 Cambridgepark Drive, Suite 101
Cambridge, MA 02140
December 16, 2022
Via EDGAR
U.S. Securities and Exchange
Commission
Division of Corporation Finance
100 F Street,
N.E.
Washington, D.C. 20549
Attn:
Jason Drory
Re:
Vor Biopharma Inc.
Registration Statement on Form S-3 (File No. 333-268798)
Request for Acceleration of Effective Date
Acceleration Request
Requested Date: December 20, 2022
Requested Time: 4:00 p.m. Eastern Time
Ladies and Gentlemen:
In
accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission take appropriate action to cause the
above-referenced Registration Statement on Form S-3 (File No. 333-268798) (the “Registration Statement”) to become effective
on December 20, 2022, at 4:00 p.m. Eastern Time, or as soon thereafter as is practicable.
Once the Registration Statement has been declared
effective, please orally confirm that event with Divakar Gupta of Cooley LLP, counsel to the Registrant, at (212) 479-6474, or in his absence, Katie Kazem at (703)
456-8043.
[Signature page follows]
Very truly yours,
Vor Biopharma Inc.
By:
/s/ Robert Ang
Robert Ang
Chief Executive Officer and Director
cc:
Robert Ang, Vor Biopharma Inc.
Nathan Jorgensen, Vor Biopharma Inc.
Divakar
Gupta, Cooley LLP
Katie Kazem, Cooley LLP
Signature Page to Company Acceleration Request – S-3
2022-12-15 - UPLOAD - Vor Biopharma Inc.
United States securities and exchange commission logo
December 15, 2022
Robert Ang, M.B.B.S.
President and Chief Executive Officer
Vor Biopharma Inc.
100 Cambridgepark Drive, Suite 101
Cambridge, MA 02140
Re:Vor Biopharma Inc.
Registration Statement on Form S-3
Filed December 14, 2022
File No. 333-268798
Dear Robert Ang:
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 Jason Drory at 202-551-8342 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Divakar Gupta
2022-03-16 - CORRESP - Vor Biopharma Inc.
CORRESP
1
filename1.htm
CORRESP
VOR BIOPHARMA INC.
100 Cambridgepark Drive, Suite 101
Cambridge, MA 02140
March 16, 2022
Via EDGAR
U.S. Securities and Exchange
Commission
Division of Corporation Finance
100 F Street,
N.E.
Washington, D.C. 20549
Attn:
Michael Davis
Re:
Vor Biopharma Inc.
Registration Statement on Form S-3 (File No. 333-263541)
Request for Acceleration of Effective Date
Acceleration Request
Requested
Date: March 18, 2022
Requested Time:
4:00 p.m. Eastern Time
Mr. Davis:
In accordance
with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission take appropriate action to cause the above-referenced
Registration Statement on Form S-3 (File No. 333-263541) (the “Registration Statement”) to become effective on March 18,
2022, at 4:00 p.m. Eastern Time, or as soon thereafter as is practicable.
Once the Registration Statement has been declared effective, please orally
confirm that event with Richard Segal of Cooley LLP, counsel to the Registrant, at (617) 937-2332.
[Signature page follows]
Very truly yours,
Vor Biopharma Inc.
By:
/s/ Robert Ang
Robert Ang
Chief Executive Officer and Director
cc:
Robert Ang, Vor Biopharma Inc.
Anthony Joyce, Vor Biopharma Inc.
Richard Segal, Cooley LLP
Daniel I.
Goldberg, Cooley LLP
2022-03-16 - UPLOAD - Vor Biopharma Inc.
United States securities and exchange commission logo
March 16, 2022
Robert Ang, M.B.B.S.
President and Chief Executive Officer
Vor Biopharma Inc.
100 Cambridgepark Drive
Suite 101
Cambridge, Massachusetts 02140
Re:Vor Biopharma Inc.
Registration Statement on Form S-3
Filed March 14, 2022
File No. 333-263541
Dear Mr. Ang:
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 Michael Davis at 202-551-4385 or Celeste Murphy at 202-551-3257 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Richard Segal
2021-02-02 - CORRESP - Vor Biopharma Inc.
CORRESP 1 filename1.htm Company Acceleration Request Vor Biopharma Inc. 100 Cambridgepark Drive Suite 400 Cambridge, Massachusetts 02140 February 2, 2021 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Eric Atallah Kevin Kuhar Joe McCann Margaret Schwartz RE: Vor Biopharma Inc. Registration Statement on Form S-1 File No. 333-252175 Acceleration Request Requested Date: February 4, 2021 Requested Time: 4:00 P.M. Eastern Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, the undersigned registrant (the “Registrant”) hereby requests that the Securities and Exchange Commission take appropriate action to cause the above-referenced Registration Statement on Form S-1 (the “Registration Statement”) to become effective on February 4, 2021, at 4:00 p.m., Eastern Time, or as soon thereafter as is practicable. Once the Registration Statement has been declared effective, please orally confirm that event with Richard Segal of Cooley LLP, counsel to the Registrant, at (617) 937-2332 or, in his absence, Layne Jacobs of Cooley LLP at (617) 937-2321. [Signature Page Follows] Very truly yours, Vor Biopharma Inc. /s/ Robert Ang Robert Ang Chief Executive Officer cc: Richard Segal, Cooley LLP Charles S. Kim, Cooley LLP [Signature Page to Acceleration Request]
2021-02-02 - CORRESP - Vor Biopharma Inc.
CORRESP 1 filename1.htm Underwriter's Acceleration Request VIA EDGAR February 2, 2021 Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Margaret Schwartz Joe McCann Eric Atallah Kevin Kuhar Re: Vor Biopharma Inc. Registration Statement on Form S-1 (as amended) (File No. 333-252175) Ladies and Gentlemen: In connection with the above-referenced Registration Statement, and pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as representatives of the several underwriters, hereby join in the request of Vor Biopharma Inc. that the effective date of the above-referenced Registration Statement be accelerated so that it will be declared effective at 4:00 p.m., Eastern Time, on February 4, 2021, or as soon thereafter as practicable. Pursuant to Rule 460 under the Act, please be advised that we will take reasonable steps to secure adequate distribution of the preliminary prospectus, to underwriters, dealers, institutions and others, prior to the requested effective time of the Registration Statement. The undersigned advise that they have complied and will continue to comply, and that they have been informed by the participating underwriters and dealers that they have complied with and will continue to comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. [SIGNATURE PAGES FOLLOW] GOLDMAN SACHS & CO. LLC By: /s/ Matthew Leskowitz Name: Matthew Leskowitz Title: Managing Director EVERCORE GROUP, L.L.C. By: /s/ Maren Winnick Name: Maren Winnick Title: Senior Managing Director BARCLAYS CAPITAL INC. By: /s/ Victoria Hale Name: Victoria Hale Title: Authorized Signatory STIFEL, NICOLAUS & COMPANY, INCORPORATED By: /s/ Nathan Thompson Name: Nathan Thompson Title: Director As Representatives of the several Underwriters. [Signature Page to Acceleration Request (Underwriters)]
2021-02-01 - CORRESP - Vor Biopharma Inc.
CORRESP 1 filename1.htm CORRESP Richard Segal +1 (617) 937-2332 rsegal@cooley.com VIA EDGAR February 1, 2021 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington D.C., 20549 Attn: Eric Atallah Kevin Kuhar Joe McCann Margaret Schwartz Re: Vor Biopharma Inc. Registration Statement on Form S-1 Submitted January 15, 2021 CIK No. 0001817229 Ladies and Gentlemen: On behalf of Vor Biopharma Inc. (the “Company”), we are providing this response letter in response to the comment (the “Comment”) received from the staff of the U.S. Securities and Exchange Commission’s Division of Corporation Finance (the “Staff”) contained in its letter, dated January 27, 2021 (the “Comment Letter”), relating to the Company’s Registration Statement on Form S-1, as filed with the Staff on January 15, 2021. The Company is concurrently filing Amendment No. 1 to the Registration Statement on Form S-1 (the “Amended Registration Statement”), which reflects changes made in response to the Comment contained in the Comment Letter and certain other changes. For your convenience, we have incorporated the Comment into this response letter in italics. Page references in the text of this response letter correspond to the page numbers of the Amended Registration Statement. Summary 1. The revised disclosure on page 2 and elsewhere concerning your VCAR33 program indicates that VCAR33 is not the subject of an on-going clinical trial but rather that a third-party is conducting a Phase 1/2 trial of a T cell therapy that uses “the same CAR construct as VCAR33.” In light of this revision, it is inappropriate to: (i) identify yourself as a “clinical-stage company”, (ii) to highlight this third-party study in your pipeline table and (iii) to refer to the third-party trial/program throughout the prospectus as “VCAR33”. With reference to your risk factor disclosure on page 27, also revise page 2 to explain that FDA may disagree with the sufficiency of your right of reference to the preclinical, manufacturing or clinical data generated by the third-party trial. Response to Comment: In response to the Comment, the Company revised its disclosure to (i) remove identifications of itself as a “clinical-stage” company, (ii) update its pipeline table and (iii) clarify the relationship between VCAR33 and the third-party trial, including by providing further information regarding the FDA requirements for demonstrating comparability. The Company also revised its disclosure on page 2 and elsewhere in the Amended Registration Statement, as appropriate, to provide additional information about the risks associated with the VCAR33 program. Cooley LLP 500 Boylston Street, 14th Floor, Boston, MA 02116-3736 t: (617) 937-2300 f: (617) 937-2400 cooley.com United States Securities and Exchange Commission February 1, 2021 Page Two The Company respectfully requests the Staff’s assistance in completing the review of this response letter. Please contact me at (617) 937 2332 with any questions regarding the Company’s responses to the Staff’s Comment or if you require further information. Thank you in advance for your attention to this matter. Sincerely, /S/ RICHARD SEGAL RICHARD SEGAL cc: Robert Ang, Vor Biopharma Inc. Nathan Jorgensen, Vor Biopharma Inc. Amy Mendel, Vor Biopharma Inc. Charles S. Kim, Cooley LLP Divakar Gupta, Cooley LLP Peter N. Handrinos, Latham & Watkins LLP Nathan Ajiashvili, Latham & Watkins LLP Cooley LLP 500 Boylston Street, 14th Floor, Boston, MA 02116-3736 t: (617) 937-2300 f: (617) 937-2400 cooley.com
2021-01-27 - UPLOAD - Vor Biopharma Inc.
United States securities and exchange commission logo
January 27, 2021
Robert Ang, M.B.B.S.
President and Chief Executive Officer
Vor Biopharma Inc.
100 Cambridgepark Drive
Suite 400
Cambridge, MA 02140
Re:Vor Biopharma Inc.
Registration Statement on Form S-1
Filed January 15, 2021
File No. 333-252175
Dear Dr. Ang:
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-1, Filed January 15, 2021
Summary, page 1
1.The revised disclosure on page 2 and elsewhere concerning your VCAR33 program
indicates that VCAR33 is not the subject of an on-going clinical trial but rather that a
third-party is conducting a Phase 1/2 trial of a T cell therapy that uses “the same CAR
construct as VCAR33.” In light of this revision, it is inappropriate to: (i) identify yourself
as a “clinical-stage company”, (ii) to highlight this third-party study in your pipeline table
and (iii) to refer to the third-party trial/program throughout the prospectus as “VCAR33”.
With reference to your risk factor disclosure on page 27, also revise page 2 to explain that
FDA may disagree with the sufficiency of your right of reference to the preclinical,
manufacturing or clinical data generated by the third-party trial.
FirstName LastNameRobert Ang, M.B.B.S.
Comapany NameVor Biopharma Inc.
January 27, 2021 Page 2
FirstName LastName
Robert Ang, M.B.B.S.
Vor Biopharma Inc.
January 27, 2021
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.
You may contact Eric Atallah at 202-551-3663 or Kevin Kuhar at 202-551-3662 if you
have questions regarding comments on the financial statements and related matters. Please
contact Margaret Schwartz at 202-551-7153 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Richard Segal, Esq.
2021-01-21 - CORRESP - Vor Biopharma Inc.
CORRESP 1 filename1.htm CORRESP Richard Segal +1 617 937 2332 rsegal@cooley.com BY EDGAR *FOIA Confidential Treatment Request* Confidential Treatment Requested by Vor Biopharma Inc. in connection with Registration Statement on Form S-1 (File No. 333-252175) January 21, 2021 U.S. Securities and Exchange Commission Office of Life Sciences Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Vor Biopharma Inc. Registration Statement on Form S-1 Filed January 15, 2021 File No. 333-252175 Ladies and Gentlemen: On behalf of Vor Biopharma Inc. (the “Company”), we are submitting this supplemental letter in further response to comment 9 received from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter dated December 3, 2020 (the “Comment Letter”) with respect to the Company’s Confidential Draft Registration Statement on Form S-1 originally submitted to the Commission on November 6, 2020, resubmitted to the Commission on December 18, 2020, and subsequently filed with the Commission on January 15, 2021 (the “Registration Statement”). Due to the commercially sensitive nature of information contained in this letter, this submission is accompanied by the Company’s request for confidential treatment for selected portions of this letter. The Company has filed a separate letter with the Office of Freedom of Information and Privacy Act Operations in connection with the confidential treatment request pursuant to Rule 83 of the Commission’s Rules on Information and Requests, 17 C.F.R. § 200.83. For the Staff’s reference, we have enclosed a copy of the Company’s letter to the Office of Freedom of Information and Privacy Act Operations as well as a copy of this correspondence, marked to show the portions redacted from the version filed via EDGAR and for which the Company is requesting confidential treatment. For the convenience of the Staff, we have recited the prior comment from the Staff in italicized type and have followed the comment with the Company’s response. Management’s Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies and Significant Judgments and Estimates Stock-Based Compensation, page 114 9. Once you have an estimated offering price or range, please explain to us how you determined the fair value of the common stock underlying your equity issuances and the reasons for any differences between the recent valuations of your common stock leading up to the IPO and the estimated offering price. This information will help facilitate our review of your accounting for equity issuances including stock compensation and beneficial conversion features. Please discuss with the staff how to submit your response. Cooley LLP 500 Boylston Street, 14th Floor, Boston, MA 02116-3736 t: (617) 937-2300 f: (617) 937-2400 cooley.com U.S. Securities and Exchange Commission January 21, 2021 Page Two Preliminary Price Range The Company advises the Staff that the Company currently expects a price range of $[*] to $[*] per share of common stock (the “Preliminary Price Range”) for its initial public offering (“IPO”). The Preliminary Price Range is based in part upon the Company’s prospects, prospects for the biotechnology industry, the general condition of the securities markets and the recent market prices of, and the demand for, publicly traded shares of generally comparable companies in the biotechnology industry, as well as input received from Goldman Sachs & Co. LLC, Evercore Group L.L.C., Barclays Capital Inc. and Stifel, Nicolaus & Company, Incorporated, the underwriters (the “Representatives”) for the IPO. The Company notes that, as is typical in IPOs, the Preliminary Price Range for the Company’s IPO was not derived using a formal determination of fair value but was determined by discussions between the Company and the Representatives based on the assessment of the foregoing factors. The Preliminary Price Range also does not reflect any stock split (or reverse stock split) that may be effected by the Company prior to the IPO; however, the Company would not expect any such stock split (or reverse stock split) to impact the Preliminary Price Range in any manner other than to decrease (or increase) it in proportion to the stock split (or reverse stock split) itself. The parameters of the bona fide price range to be included in the Registration Statement at the time of the commencement of the Company’s road show will be subject to then-current market conditions, continuing discussions with the Representatives and material business developments impacting the Company, and due to the volatility in the securities markets. In any event, the Company confirms to the Staff that the bona fide price range will comply with Item 501(b)(3) of Regulation S-K and CD&I 134.04. Determinations of the Fair Value of Common Stock As there has been no public market for the Company’s common stock to date, the estimated fair value of its common stock has been determined by the Board, as of the date of each option grant, with input from management, considering the Company’s most recent arm’s-length sales of its preferred stock and the most recent third-party valuation of its common stock, as well as the Board’s assessment of additional objective and subjective factors that the Board believed were relevant and which may have changed from the date of the most recent third-party valuation through the date of the grant. The Board considered various objective and subjective factors to determine the fair value of the common stock as of each grant date, including: • contemporaneous valuations performed by an independent third-party valuation firm; • the Company’s stage of development and material risks related to its business; • the progress of the Company’s research and development programs, including the status and results of preclinical studies for its product candidates; • the Company’s’ business conditions and projections; • sales of the Company’s preferred stock; • the rights, preferences and privileges of the Company’s preferred stock relative to its common stock; • lack of marketability of its common and preferred stock as a private company; • the Company’s operating results and financial performance; • the likelihood of achieving a liquidity event, such as an IPO or sale, in light of prevailing market conditions; • the trends, developments and conditions in the life sciences and biotechnology industry sectors; FOIA Confidential Treatment Requested by Vor Biopharma Inc. Cooley LLP 500 Boylston Street, 14th Floor, Boston, MA 02116-3736 t: (617) 937-2300 f: (617) 937-2400 cooley.com U.S. Securities and Exchange Commission January 21, 2021 Page Three • analysis of initial public offerings and the market performance and stock price volatility of similar public companies in the life sciences and biopharmaceutical sectors; and • the economy in general. The third-party valuations of the Company’s common stock that the Board considered in making its determinations were prepared in accordance with the American Institute of Certified Public Accountants Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation (the “Practice Guide”), which prescribes several valuation approaches for determining the value of an enterprise, such as the cost, market and income approaches, and various methodologies for allocating the value of an enterprise to its capital structure and specifically the common stock. In accordance with the Practice Guide, the Company considered the following methods for determining and allocating the enterprise value across its classes and series of capital stock to determine the fair value of its common stock at each valuation date. • Option Pricing Method (“OPM”). The OPM estimates the value of the common equity of the Company using the various inputs in the Black-Scholes option pricing model. The OPM treats the rights of the holders of common stock as equivalent to that of call options on any value of the enterprise above certain break points of value based upon the liquidation preferences of the holders of the Company’s preferred stock, as well as their rights to participation, and the stock prices of the outstanding options. Thus, the value of the common stock can be determined by estimating the value of its portion of each of these call option rights. Under this method, the common stock has value only if the funds available for distribution to stockholders exceed the value of the liquidation preference at the time of a liquidity event, such as a merger or sale. Given the common stock represents a non-marketable equity interest in a private enterprise, an adjustment to the preliminary value estimates had to be made to account for the lack of liquidity that a stockholder experiences. This adjustment is commonly referred to as a discount for lack of marketability (“DLOM”). • Probability-Weighted Expected Return Method (“PWERM”). The PWERM is a scenario-based analysis that estimates the value per share based on the probability-weighted present value of expected future investment returns, considering each of the possible outcomes considered by the Company, as well as the economic and control rights of each share class. • Hybrid Method. The hybrid method is a weighted-average method that combines both OPM and PWERM. Weighting allocations are assigned to the OPM and PWERM methods factoring in possible future liquidity events. As of each award date set forth in the table below under “Summary of Recent Equity Awards,” the Board evaluated any recent events and their potential impact on the estimated fair value per share of the Company’s common stock. For grants of stock awards made on dates for which there was no contemporaneous independent third-party valuation, the Board determined the fair value of the Company’s common stock on the date of grant taking into consideration the immediately preceding independent third-party valuation report as well as other pertinent information available to it at the time of the grant. The valuation methodology used in valuations through June 30, 2020 was the OPM, and after June 30, 2020, the valuation methodology changed to the hybrid method, as the Company had better visibility into the near-term timing of a potential IPO, but still considered the uncertainty around the Company’s value should an IPO not occur. FOIA Confidential Treatment Requested by Vor Biopharma Inc. Cooley LLP 500 Boylston Street, 14th Floor, Boston, MA 02116-3736 t: (617) 937-2300 f: (617) 937-2400 cooley.com U.S. Securities and Exchange Commission January 21, 2021 Page Four Fair Value Reassessment In the course of preparing the Company’s financial statements for the nine months ended September 30, 2020, the Company considered the fair value of common stock for purposes of stock options granted in August 2020. The Company evaluated the use of the contemporaneous valuation performed as of June 30, 2020 and determined that certain inputs utilized to determine the equity value as of June 30, 2020 should be updated as a result of certain developments in the business in August 2020, including initial discussions regarding a potential IPO. These developments impacted both the probability and expectations related to the timing of milestones triggering the sale of additional shares of its Series B Preferred Stock, and therefore were important to consider to reflect the fair value of the Company’s common stock for financial reporting purposes for stock option grants in August 2020. As a result, the contemporaneous valuation as of June 30, 2020 was not utilized for financial reporting purposes. Summary of Recent Equity Awards The following table summarizes all stock option awards granted by the Company since January 1, 2020, including the Company’s reassessment of the fair value of its common stock for each option granted in August 2020, as described above: Option Grant Dates Number of Shares Subject to Options Granted Fair Value Per Common Share for Financial Reporting Purposes Exercise Price Intrinsic Value Per Underlying Common Share March 10, 2020 [ *] $ [ *] $ [ *] — April 11, 2020 [ *] $ [ *] $ [ *] — August 21, 2020 [ *] $ [ *](1) $ [ *] $ [ *] August 25, 2020 [ *] $ [ *](1) $ [ *] $ [ *] August 31, 2020 [ *] $ [ *](1) $ [ *] $ [ *] September 15, 2020 [ *] $ [ *] $ [ *] — October 22, 2020 [ *] $ [ *] $ [ *] — November 18, 2020 [ *] $ [ *] $ [ *] — December 11, 2020 [ *] $ [ *] $ [ *] — (1) At the time of this option grant, the Board determined the fair value of the Company’s common stock after taking into account the Company’s most recently available contemporaneous third-party valuation of its common stock as of such grant date, and other objective and subjective factors as appropriate. However, solely for financial reporting purposes, the fair value of the Company’s common stock at the date of this grant was adjusted in connection with a retrospective fair value assessment using hindsight and an updated third-party valuation of its common stock as of such grant date, as further described under the subsection entitled “Fair Value Reassessment” above. FOIA Confidential Treatment Requested by Vor Biopharma Inc. Cooley LLP 500 Boylston Street, 14th Floor, Boston, MA 02116-3736 t: (617) 937-2300 f: (617) 937-2400 cooley.com U.S. Securities and Exchange Commission January 21, 2021 Page Five The above table excludes an option, granted to an advisor of the Company on October 22, 2020, to purchase [*] shares of common stock at an exercise price of $[*], which was higher than the fair market value of the Company’s common stock of $[*] as determined by the Board. The option was granted with an exercise price greater than the fair market value in order to create additional long-term incentives for the advisor. Summary of Methodologies and Third-Party Valuations The following is a summary of the methodologies used in determining the estimated fair values of the Company’s common stock with the assistance of independent third-party valuation reports for the options listed above. February 5, 2020 Valuation (Used for March 10, 2020 and April 11, 2020 Option Grants) An independent third-party valuation specialist performed a contemporaneous valuation of the Company’s common stock as of February 5, 2020, which determined a fair value of $[*] per share (the “February 2020 Valuation”). For the February 2020 Valuation, the third-party valuation first determined an equity value by applying (1) a growth factor based on the change in the market index and guideline company market capitalizations between the date of its prior valuation of the Company in February 2019 (which determined a fair value of $[*] per share) and the date of the February 2020 Valuation, (2) a valuation adjustment to reflect recent advancements in the Company’s research and development activities, based on value decreases and increases of comparable companies after public announcements of similar advancements and (3) an adjustment for cash received in a milestone closing of a sale of the Company’s Series A-2 Preferred stock in February 2020. Then, the OPM was used to allocate the equity value across the Company’s classes and series of capital stock to determine the fair value of the Company’s common stock. In determining the total implied equity value under the OPM, the Company used an estimated volatility of [*]%, an estimated time to liquidity of [*] years, based on management’s then best estimates of a liquidity event at such time, and a DLOM of [*]%. On March 10, 2020 and April 11, 2020, the Board granted options to purchase [*] and [*] shares of common stock, respectively, at exercise prices equal to $[*] per sha
2021-01-15 - CORRESP - Vor Biopharma Inc.
CORRESP 1 filename1.htm CORRESP Richard Segal +1 (617) 937-2332 rsegal@cooley.com VIA EDGAR January 15, 2021 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington D.C., 20549 Attn: Eric Atallah Kevin Kuhar Joe McCann Margaret Schwartz Re: Vor Biopharma Inc. Amendment No. 1 to the Draft Registration Statement on Form S-1 Submitted December 18, 2020 CIK No. 0001817229 Ladies and Gentlemen: On behalf of Vor Biopharma Inc. (the “Company”), we are providing this response letter in response to the comments (the “Comments”) received from the staff of the U.S. Securities and Exchange Commission’s Division of Corporation Finance (the “Staff”) contained in its letter, dated January 4, 2021 (the “Comment Letter”), relating to the Company’s Amendment No. 1 to the Draft Registration Statement on Form S-1, as confidentially submitted to the Staff on December 18, 2020. The Company is concurrently filing the Registration Statement on Form S-1 (the “Registration Statement”), which reflects changes made in response to certain of the Comments contained in the Comment Letter and certain other changes. The numbering of the paragraphs below corresponds to the numbering of the Comments contained in the Comment Letter, which for your convenience we have incorporated into this response letter in italics. Page references in the text of this response letter correspond to the page numbers of the Registration Statement. Capitalized terms used in this response letter but not otherwise defined in this response letter shall have the meanings set forth in the Registration Statement. Summary 1. We note your response to our prior comment number 1. Please revise your disclosure in the Overview section to clearly state that your lead candidate, VOR33 is preclinical. To explain the novelty and uniqueness of your approach and to highlight the associated challenges, please also revise the Overview to disclose that (i) engineered hematopoietic stem cells have never undergone clinical trials and (ii) the removal of CD33 from hematopoietic stem cells has never been studied in clinical trials. Response to Comment 1: In response to the Staff’s comment, the Company revised its disclosure as requested on page 2 of the Registration Statement. Cooley LLP 500 Boylston Street, 14th Floor, Boston, MA 02116-3736 t: (617) 937-2300 f: (617) 937-2400 cooley.com United States Securities and Exchange Commission January 15, 2021 Page Two 2. We note your response to our prior comment number 4. On page 18 you state that you have not yet filed an IND application for VOR33. Please revise pages 2 or 4 to state when you plan to submit an IND for VOR33 for AML. Response to Comment 2: In response to the Staff’s comment, the Company revised its disclosure as requested on pages 2 and 4 of the Registration Statement. Our Proprietary Vor Platform 3. We note that your disclosure on page 3 highlights that you have a highly efficient manufacturing process. Please revise page 3 to clarify the meaning of this statement in light of your risk factor disclosure on page 39, where you state that you “have not demonstrated that eHSCs or VCAR33 can be frozen and thawed in large quantities without damage, in a cost-efficient manner and without degradation” and, further, that you “may not be able to commercialize eHSCs, VCAR33 or other cell-based companion therapeutics we may develop on a large scale or in a cost-effective manner.” Response to Comment 3: The Company respectfully advises the staff that, while the Company has conducted preclinical tests of its manufacturing processes to establish that these processes are highly efficient and permit rapid manufacturing of eHSC products for its initial clinical trials, and while the Company believes these manufacturing processes can be scaled for commercialization of its eHSCs, the Company has not yet developed manufacturing capabilities at the scale required for later stage clinical trials or commercialization. To clarify its current manufacturing capabilities and the associated risks, and in response to the Staff’s comment, the Company has revised its disclosure on pages 3 and 40 of the Registration Statement. Risk Factors 4. We note your response to prior comment 6. With reference to your disclosure on page 28, please revise to clarify whether you will need to work with Pfizer to satisfy the requirement that you reference in this risk factor. In this regard, it should be clear whether you will need to negotiate a license and/or supply agreement so that Mylotarg can be used in combination or in sequence with VOR33. Response to Comment 4: In response to the Staff’s comment, the Company revised its disclosure as requested on pages 28 of the Registration Statement. Business 5. We note your response to our prior comment number 11. Please revise pages 103 and 127 to expressly state that your companion therapeutic VCAR33, which is intended to be used in conjunction with VOR33, employs viral vectors. Response to Comment 5: In response to the Staff’s comment, the Company revised its disclosure as requested on pages 103 and 127 of the Registration Statement. The Company respectfully requests the Staff’s assistance in completing the review of this response letter. Please contact me at (617) 937 2332 with any questions regarding the Company’s responses to the Staff’s Comments or if you require further information. Thank you in advance for your attention to this matter. Cooley LLP 500 Boylston Street, 14th Floor, Boston, MA 02116-3736 t: (617) 937-2300 f: (617) 937-2400 cooley.com United States Securities and Exchange Commission January 15, 2021 Page Three Sincerely, /S/ RICHARD SEGAL RICHARD SEGAL cc: Robert Ang, Vor Biopharma Inc. Nathan Jorgensen, Vor Biopharma Inc. Amy Mendel, Vor Biopharma Inc. Charles S. Kim, Cooley LLP Divakar Gupta, Cooley LLP Peter N. Handrinos, Latham & Watkins LLP Nathan Ajiashvili, Latham & Watkins LLP Cooley LLP 500 Boylston Street, 14th Floor, Boston, MA 02116-3736 t: (617) 937-2300 f: (617) 937-2400 cooley.com
2021-01-04 - UPLOAD - Vor Biopharma Inc.
United States securities and exchange commission logo
January 4, 2021
Robert Ang, M.B.B.S.
President and Chief Executive Officer
Vor Biopharma Inc.
100 Cambridgepark Drive
Suite 400
Cambridge, MA 02140
Re:Vor Biopharma Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted December 18, 2020
CIK No. 0001817229
Dear Dr. Ang:
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 December 3, 2020 letter.
Amendment No. 1 to Draft Registration Statement on Form S-1, Submitted December 18, 2020
Summary, page 1
1.We note your response to our prior comment number 1. Please revise your disclosure in
the Overview section to clearly state that your lead candidate, VOR33 is preclinical. To
explain the novelty and uniqueness of your approach and to highlight the associated
challenges, please also revise the Overview to disclose that (i) engineered hematopoietic
stem cells have never undergone clinical trials and (ii) the removal of CD33 from
hematopoietic stem cells has never been studied in clinical trials.
FirstName LastNameRobert Ang, M.B.B.S.
Comapany NameVor Biopharma Inc.
January 4, 2021 Page 2
FirstName LastName
Robert Ang, M.B.B.S.
Vor Biopharma Inc.
January 4, 2021
Page 2
2.We note your response to our prior comment number 4. On page 18 you state that you
have not yet filed an IND application for VOR33. Please revise pages 2 or 4 to state when
you plan to submit an IND for VOR33 for AML.
Our Proprietary Vor Platform, page 2
3.We note that your disclosure on page 3 highlights that you have a highly efficient
manufacturing process. Please revise page 3 to clarify the meaning of this statement in
light of your risk factor disclosure on page 39, where you state that you "have not
demonstrated that eHSCs or VCAR33 can be frozen and thawed in large quantities
without damage, in a cost-efficient manner and without degradation" and, further, that you
"may not be able to commercialize eHSCs, VCAR33 or other cell-based companion
therapeutics we may develop on a large scale or in a cost-effective manner."
Risk Factors
Development of a product candidate such as VOR33, which is intended for use in combination or
in sequence with an already approved therapy.., page 27
4.We note your response to prior comment 6. With reference to your disclosure on page 28,
please revise to clarify whether you will need to work with Pfizer to satisfy the
requirement that you reference in this risk factor. In this regard, it should be clear whether
you will need to negotiate a license and/or supply agreement so that Mylotarg can be used
in combination or in sequence with VOR33.
Business, page 121
5.We note your response to our prior comment number 11. Please revise pages 103 and 127
to expressly state that your companion therapeutic VCAR33, which is intended to be used
in conjunction with VOR33, employs viral vectors.
You may contact Eric Atallah at 202-551-3663 or Kevin Kuhar at 202-551-3662 if you
have questions regarding comments on the financial statements and related matters. Please
contact Margaret Schwartz at 202-551-7153 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Richard Segal, Esq.
2020-12-04 - UPLOAD - Vor Biopharma Inc.
United States securities and exchange commission logo
December 3, 2020
Robert Ang, M.B.B.S.
President and Chief Executive Officer
Vor Biopharma Inc.
100 Cambridgepark Drive
Suite 400
Cambridge, MA 02140
Re:Vor Biopharma Inc.
Draft Registration Statement on Form S-1
Submitted November 6, 2020
CIK No. 0001817229
Dear Dr. Ang:
We have reviewed your draft registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-1, Submitted November 6, 2020
Summary, page 1
1.With reference to your disclosure on page 23, please revise the Overview to explain that
your VOR33 candidate is pre-clinical and there have been no clinical trials of any
engineered HSCs (eHSCs) to date.
2.Please tell us why VOR33 for MDS and MPN should be highlighted in the table given
that you have not selected a development candidate and you provide limited disclosure in
the Business section concerning this program.
3.With reference to your disclosure on page 21, please revise the disclosure on page 3 to
FirstName LastNameRobert Ang, M.B.B.S.
Comapany NameVor Biopharma Inc.
December 3, 2020 Page 2
FirstName LastNameRobert Ang, M.B.B.S.
Vor Biopharma Inc.
December 3, 2020
Page 2
clarify that the Center for International Blood and Marrow Transplant Research also
oversees the VCAR33 trial.
4.On page 3, please revise to state when you plan to submit an IND for VOR33 for AML, as
you state on pages 20-21, and clearly explain that the Phase 1 clinical trial will evaluate
VOR33 in combination with Mylotarg as you state on page 26. Please also further
describe the mechanism of action for VCAR33, including the meaning of “bridge-to-
transplant monotherapy” and how the therapy uses autologous T cells from the patient.
Please clarify in the Summary the extent to which you view VCAR33 as a distinct and
standalone treatment option.
5.Please revise the Summary to make clear, as you do on pages 26 and 100, that you expect
VOR33 and any other eHSC product candidates will be required to be used in
combination with another therapy.
6.Please revise your disclosure on page 3 to explain that Mylotarg is a commercialized
therapy owned by a third-party. Given that your one clinical stage program incorporates
this third-party therapy, also revise the Summary to put your "single company solution"
statement into context.
7.Please revise the Summary to briefly explain what a CAR-T therapy is so it is clear how it
differs from stem cell transplants.
Risk Factors, page 13
8.On page 58 you state that you rely on CRISPR-Cas9 genome engineering technology to
create VOR33 and will need a license to this technology prior to commercialization.
Please revise to discuss, as applicable, the general timeline for obtaining licenses to
genome engineering technology. For instance, explain whether this process typically
commences during early or late clinical development or after regulatory approval has been
received. Also, revise to discuss whether the licenses granted are typically exclusive or
non-exclusive in nature. Discuss, if known, whether there are existing licenses covering
the field of use(s) that you are targeting and that could prevent or negatively impact
commercialization.
Management's Discussion and Analysis of Financial Condition and Results of Operations
Critical Accounting Policies and Significant Judgments and Estimates
Stock-Based Compensation, page 114
9.Once you have an estimated offering price or range, please explain to us how you
determined the fair value of the common stock underlying your equity issuances and the
reasons for any differences between the recent valuations of your common stock leading
up to the IPO and the estimated offering price. This information will help facilitate our
review of your accounting for equity issuances including stock compensation and
beneficial conversion features. Please discuss with the staff how to submit your response.
FirstName LastNameRobert Ang, M.B.B.S.
Comapany NameVor Biopharma Inc.
December 3, 2020 Page 3
FirstName LastNameRobert Ang, M.B.B.S.
Vor Biopharma Inc.
December 3, 2020
Page 3
Business, page 119
10.Please revise page 119 to further describe your arrangement with the Center for
International Blood and Marrow Transplant Research, including any contractual or
monetary commitments. If required by Item 601(b)(10) of Regulation S-K, please also file
any agreement with the Center for International Blood and Marrow Transplant Research
or advise.
11.On page 125 and elsewhere you state: “Our approach also does not involve the insertion
of new genetic material, thereby avoiding complications related to the use of delivery
modalities necessary for gene insertion, such as viral vectors.” Please revise the statement
on page 125 and elsewhere as appropriate to disclose that your companion therapeutic
VCAR33 to be used in conjunction with VOR33 employs viral vectors, as you state on
page 24.
12.We note the following statement on page 126 and the corresponding graphic on page 127:
“In addition, as shown in the right graphic below, we observed in other preclinical studies
that our process resulted in 88% of eHSCs having removal of CD33 on both copies, or
alleles, of the gene, effectively eliminating any expression of CD33.” Please include
further details for this studies, such as the number of subjects.
13.On page 132, we note that in in vitro studies you “observed few differences in cell killing
at extreme Mylotarg concentrations.” Please revise to state the dosage range that Mylotarg
is approved for and the dose typically administered.
14.Please provide the number of subjects for your mice studies on pages 133-135.
15.Please revise the disclosure to describe the bottom left panel of the figure at the top of
page 134.
16.On page 135 you state: “…we observed statistically significant lower rates of CD33
surface proteins…” Please provide the corresponding p-values and describe how they
relate to the FDA’s standards of efficacy. Please also revise to ensure each vertical axis in
the graphic on page 135 is explained.
17.We note when describing the royalty term for the Columbia Agreement described on page
149 and the Patent License described on page 50, you state that the term will expire on the
latest to occur of several events, including the expiration date of the last valid claim on a
country-by-country basis. Please revise to clarify when these claims are due to expire.
18.Please revise pages 153-154 to provide the specific jurisdictions to which your owned and
licensed patents and patent applications relate.
19.Your disclosure on page 137 states that you expect that engraftment of VOR33 will occur
within 28 days of administration. Please tell us how this timeframe compares to
engraftment for existing HSCT therapies.
FirstName LastNameRobert Ang, M.B.B.S.
Comapany NameVor Biopharma Inc.
December 3, 2020 Page 4
FirstName LastName
Robert Ang, M.B.B.S.
Vor Biopharma Inc.
December 3, 2020
Page 4
20.Please revise page 141 to state the number of subjects covered by each of the two phases
of the VCAR33 Phase 1/2 clinical trial.
General
21.Please supplementally provide us with copies of all written communications, as defined in
Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf,
present to potential investors in reliance on Section 5(d) of the Securities Act, whether or
not they retain copies of the communications.
You may contact Eric Atallah at (202) 551-3663 or Kevin Kuhar at (202) 551-3662 if
you have questions regarding comments on the financial statements and related matters. Please
contact Margaret Schwartz at (202) 551-7153 or Joe McCann at (202) 551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences