Loaded from persisted store.
Threads
All Filings
SEC Comment Letters
Company Responses
Letter Text
Q32 Bio Inc.
Awaiting Response
0 company response(s)
High
Q32 Bio Inc.
Response Received
2 company response(s)
High - file number match
↓
↓
Q32 Bio Inc.
Response Received
1 company response(s)
High - file number match
↓
Q32 Bio Inc.
Response Received
1 company response(s)
High - file number match
↓
Q32 Bio Inc.
Response Received
3 company response(s)
High - file number match
↓
↓
↓
Q32 Bio Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2024-02-09
Q32 Bio Inc.
Summary
Generating summary...
Q32 Bio Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2023-03-14
Q32 Bio Inc.
Summary
Generating summary...
↓
Q32 Bio Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-04-08
Q32 Bio Inc.
Summary
Generating summary...
↓
Q32 Bio Inc.
Response Received
3 company response(s)
High - file number match
SEC wrote to company
2018-03-06
Q32 Bio Inc.
Summary
Generating summary...
↓
Company responded
2018-03-14
Q32 Bio Inc.
References: January 19, 2018 | March 6, 2018
Summary
Generating summary...
↓
↓
Q32 Bio Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2018-02-12
Q32 Bio Inc.
Summary
Generating summary...
Q32 Bio Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2018-01-19
Q32 Bio Inc.
Summary
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-28 | SEC Comment Letter | Q32 Bio Inc. | DE | 001-38433 | Read Filing View |
| 2025-08-26 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2025-07-31 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2025-07-30 | SEC Comment Letter | Q32 Bio Inc. | DE | 001-38433 | Read Filing View |
| 2025-04-17 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2025-04-16 | SEC Comment Letter | Q32 Bio Inc. | DE | 333-286491 | Read Filing View |
| 2024-04-25 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2024-04-25 | SEC Comment Letter | Q32 Bio Inc. | DE | 333-278829 | Read Filing View |
| 2024-02-13 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2024-02-12 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2024-02-09 | SEC Comment Letter | Q32 Bio Inc. | DE | 333-276093 | Read Filing View |
| 2024-01-26 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2024-01-22 | SEC Comment Letter | Q32 Bio Inc. | DE | 333-276093 | Read Filing View |
| 2023-03-16 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2023-03-14 | SEC Comment Letter | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2019-04-08 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2019-04-08 | SEC Comment Letter | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2018-03-23 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2018-03-23 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2018-03-14 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2018-03-06 | SEC Comment Letter | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2018-02-12 | SEC Comment Letter | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2018-01-19 | SEC Comment Letter | Q32 Bio Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-28 | SEC Comment Letter | Q32 Bio Inc. | DE | 001-38433 | Read Filing View |
| 2025-07-30 | SEC Comment Letter | Q32 Bio Inc. | DE | 001-38433 | Read Filing View |
| 2025-04-16 | SEC Comment Letter | Q32 Bio Inc. | DE | 333-286491 | Read Filing View |
| 2024-04-25 | SEC Comment Letter | Q32 Bio Inc. | DE | 333-278829 | Read Filing View |
| 2024-02-09 | SEC Comment Letter | Q32 Bio Inc. | DE | 333-276093 | Read Filing View |
| 2024-01-22 | SEC Comment Letter | Q32 Bio Inc. | DE | 333-276093 | Read Filing View |
| 2023-03-14 | SEC Comment Letter | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2019-04-08 | SEC Comment Letter | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2018-03-06 | SEC Comment Letter | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2018-02-12 | SEC Comment Letter | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2018-01-19 | SEC Comment Letter | Q32 Bio Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-08-26 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2025-07-31 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2025-04-17 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2024-04-25 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2024-02-13 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2024-02-12 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2024-01-26 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2023-03-16 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2019-04-08 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2018-03-23 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2018-03-23 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
| 2018-03-14 | Company Response | Q32 Bio Inc. | DE | N/A | Read Filing View |
2025-08-28 - UPLOAD - Q32 Bio Inc. File: 001-38433
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> August 28, 2025 Lee Kalowski CFO and President Q32 Bio Inc. 830 Winter Street Waltham, MA 02451 Re: Q32 Bio Inc. Form 10-K for the year ended December 31, 2024 Filed March 11, 2025 File No. 001-38433 Dear Lee Kalowski: We have completed our review of your filing. 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. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2025-08-26 - CORRESP - Q32 Bio Inc.
CORRESP 1 filename1.htm CORRESP Goodwin Procter LLP The New York Times Building 620 Eighth Avenue New York, NY 10018 goodwinlaw.com +1 (212) 813-8800 August 26, 2025 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549 Attention: Sasha Parikh and Kevin Vaughn Re: Q32 Bio Inc. Form 10-K for the year ended December 31, 2024 Filed March 11, 2025 File No. 001-38433 Ladies and Gentlemen: On behalf of Q32 Bio Inc., or the Company, this letter responds to the comments set forth in the letter to the Company dated July 30, 2025 from the staff of the Securities and Exchange Commission, or the Staff. For your convenience, we have repeated the Staff’s comment from the July 30, 2025 letter in italics, and the Company’s response is provided below. Form 10-K for the year ended December 31, 2024 Notes to consolidated financial statements 15. Agreements with Horizon, page F-31 1. Please tell us and revise your disclosure in future filings to address the following: • breakout the $75.1 million contingent consideration between regulatory and sales milestones; • provide a summary of the regulatory milestones and the related consideration that needs to be achieved; • disclose the extent to which you are required to repay Horizon the $55 million received under your prior agreements with Horizon or any of the additional $20 million if bempikibart does not meet any of the milestones; and • tell us your expected accounting for the liability if bempikibart does not achieve any of the milestones and if no payments are required. Response : The Company respectfully acknowledges the Staff’s comment and advises the Staff that in future filings it will provide additional disclosure, including the breakout of the $75.1 million contingent consideration between regulatory and sales milestones, a summary of the regulatory milestones and the related consideration that needs to be achieved and any applicable repayment obligations under prior agreements with Horizon. The additional disclosure will be included in the Company’s future annual and quarterly reports under the Securities Exchange Act of 1934, as amended, beginning with the Company’s upcoming Quarterly Report on Form 10-Q for the quarter ended September 30, 2025. Goodwin Procter LLP The New York Times Building 620 Eighth Avenue New York, NY 10018 goodwinlaw.com +1 (212) 813-8800 Upon entering into the Horizon Termination Agreement (as defined below), the Company recognized a refund liability of $55 million for consideration previously received from Horizon based on the guidance in ASC 606-10-32-10 related to its obligation to pay Horizon regulatory and sales milestone payments with respect to bempikibart. Consistent with the guidance in ASC 606-10-32-10 and ASC 405-20, Extinguishments of Liabilities , the Company advises the Staff that if bempikibart does not achieve any of the milestones and if no payments are triggered, the Company would expect to reverse the refund liability and recognize a corresponding adjustment to revenue as the refund privilege would have expired. The following is an example of how the Company expects to provide this additional disclosure, which will be included in the notes to the consolidated financial statements ( additions are italicized ): 15. Agreements with Horizon From August 2022 until November 2023, Legacy Q32 was a party to the Collaboration and Option Agreement (the “Horizon Collaboration Agreement”) and the Asset Purchase Agreement (the “Purchase Agreement”, and together with the Horizon Collaboration Agreement, the “Horizon Agreements”), each between Legacy Q32 and Horizon Therapeutics Ireland DAC (“Horizon”), pursuant to which Legacy Q32 received $55.0 million in initial consideration and staged development funding for the completion of the two ongoing Phase 2 trials for bempikibart, and Horizon had an option to acquire the bempikibart program at a prespecified price, subject to certain adjustments. The Company has received $55.0 million of the $55.0 million transaction price from Horizon. In October 2023, Amgen Inc. (“Amgen”) completed its acquisition of Horizon Therapeutics public limited company (“Horizon plc”). Following the closing of Amgen’s acquisition of Horizon plc, the Company agreed with Amgen to mutually terminate the Horizon Agreements and, in November 2023, the Company and Horizon entered into a termination agreement (the “Horizon Termination Agreement”), pursuant to which Horizon’s option to acquire the bempikibart program was terminated. As a result, the Company retained all initial consideration and development funding received under the Horizon Collaboration Agreement (as defined below) and regained full development and commercial rights to bempikibart. In consideration for the Horizon Termination Agreement, the Company agreed to pay Horizon regulatory and sales milestones payments of up to an aggregate amount of $75.1 million upon the first achievement of certain regulatory and sales milestones with respect to bempikibart. Prior to its entry into the Horizon Termination Agreement, the Company concluded that the consideration allocated to the research service performance obligations should be recognized over time as Horizon received the benefit of the research activities as the activities were performed. The Company determined that this method was most appropriate as progress towards completion of research was largely driven by time and effort spent and costs incurred to perform this research. The Horizon Termination Agreement is accounted for as a modification because it does not result in the addition of distinct goods or services. Since the two performance obligations and the material right were terminated with no further performance obligations, the Company recognized the remaining deferred revenue in the fourth quarter of 2023. Upon the execution of the Horizon Termination Agreement, the Company became obligated to pay Horizon up to $75.1 million contingent on regulatory and sales-based milestones or up to $20.1 million in excess of the cash received , consisting of a $5 million payment upon the first regulatory approval in the U.S. or in any of five specified major western European markets, and up to $70.1 million ranging from mid-single digit to low-double digit millions of dollars upon the achievement of specified annual sales thresholds, which range from exceeding $250 million to exceeding $1.5 billion. If bempikibart does not achieve the milestones set forth in the Horizon Termination Agreement, the Company will not be obligated to make any payments nor repay any amounts to Horizon. Goodwin Procter LLP The New York Times Building 620 Eighth Avenue New York, NY 10018 goodwinlaw.com +1 (212) 813-8800 These potential payments to Horizon are not in exchange for a distinct good or service; therefore, the Company accounts for variable consideration payable to Horizon as a reduction of the transaction price under FASB ASC Topic 606, Revenue from Contracts with Customers . The Company concluded that the $55.0 million of arrangement consideration previously recognized should be fully constrained as a result of the variable contingent consideration payable to Horizon, and accordingly, all amounts previously recognized as revenue were reversed in the fourth quarter of 2023 and a refund liability was established for the $55.0 million cash received during the term of the Horizon Collaboration Agreement. No amounts have been recognized related to the remaining potential payment to Horizon (up to $20.1 million) as it is not probable that the respective milestones will be achieved at this time. If you or any other member of the Staff have any questions with regard to the foregoing response, would like to discuss any of the matters covered in this letter, or otherwise require additional information, please contact me at (212) 459-7238. Sincerely, /s/ Sarah Ashfaq Sarah Ashfaq, Esq. Cc: Jodie Morrison, Chief Executive Officer, Q32 Bio Inc. Lee Kalowski, Chief Financial Officer and President, Q32 Bio Inc. Jackie Mercier, Goodwin Procter LLP
2025-07-31 - CORRESP - Q32 Bio Inc.
CORRESP 1 filename1.htm CORRESP July 31, 2025 VIA EDGAR Sasha Parikh and Kevin Vaughn United States Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549 Re: Q32 Bio Inc. Form 10-K for the fiscal year ended December 31, 2024 Filed March 11, 2025 File No. 001-38433 Dear Ms. Parikh and Mr. Vaughn: On behalf of Q32 Bio Inc. (the “Company”), we acknowledge receipt of the Securities and Exchange Commission Staff’s comment letter dated July 30, 2025, regarding the Company’s Form 10-K for the Fiscal Year Ended December 31, 2024. The comment letter requests that the Company respond within ten business days or inform the Staff when the Company will respond. The Company hereby requests an extension of ten additional business days to respond by no later than August 27, 2025. This additional time will enable the necessary internal review related to the Company’s response to the comment letter. Thank you for your consideration of our request for an extension. If you have any questions, please do not hesitate to contact me at SAshfaq@goodwinlaw.com or (212) 459-7238. Sincerely, /s/ Sarah Ashfaq
2025-07-30 - UPLOAD - Q32 Bio Inc. File: 001-38433
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> July 30, 2025 Lee Kalowski CFO and President Q32 Bio Inc. 830 Winter Street Waltham, MA 02451 Re: Q32 Bio Inc. Form 10-K for the year ended December 31, 2024 Filed March 11, 2025 File No. 001-38433 Dear Lee Kalowski: We have limited our review of your filing to the financial statements and related disclosures and have the following comment(s). Please respond to this letter within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Form 10-K for the year ended December 31, 2024 Notes to consolidated financial statements 15. Agreements with Horizon, page F-31 1. Please tell us and revise your disclosure in future filings to address the following: breakout the $75.1 million contingent consideration between regulatory and sales milestones; provide a summary of the regulatory milestones and the related consideration that needs to be achieved; disclose the extent to which you are required to repay Horizon the $55 million received under your prior agreements with Horizon or any of the additional $20 million if bempikibart does not meet any of the milestones; and tell us your expected accounting for the liability if bempikibart does not achieve any of the milestones and if no payments are required. In closing, we remind you that the company and its management are responsible for July 30, 2025 Page 2 the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Sasha Parikh at 202-551-3627 or Kevin Vaughn at 202-551-3494 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences </TEXT> </DOCUMENT>
2025-04-17 - CORRESP - Q32 Bio Inc.
CORRESP 1 filename1.htm CORRESP Q32 Bio Inc. 830 Winter Street Waltham, Massachusetts 02451 April 17, 2025 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Re: Q32 Bio Inc. Registration Statement on Form S-3 (File No. 333-286491) Request for Acceleration of Effective Date Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “ Act ”), Q32 Bio Inc. (the “ Company ”) hereby respectfully requests that the effective date of the Company’s Registration Statement on Form S-3 (File No. 333-286491) (the “ Registration Statement ”), be accelerated by the Securities and Exchange Commission to 4:00 p.m. Eastern time, on April 21, 2025, 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. We request that we be notified of such effectiveness by a telephone call to Sarah Ashfaq of Goodwin Procter LLP at (212) 459-7238 and that such effectiveness also be confirmed in writing. Very truly yours, Q32 Bio Inc. By: /s/ Lee Kalowski Name: Lee Kalowski Title: Chief Financial Officer and President cc: Sarah Ashfaq, Goodwin Procter LLP
2025-04-16 - UPLOAD - Q32 Bio Inc. File: 333-286491
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 16, 2025 Jodie Morrison Chief Executive Officer Q32 Bio Inc. 830 Winter Street Waltham, MA 02451 Re: Q32 Bio Inc. Registration Statement on Form S-3 Filed April 11, 2025 File No. 333-286491 Dear Jodie Morrison: 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: Sarah Ashfaq, Esq. </TEXT> </DOCUMENT>
2024-04-25 - CORRESP - Q32 Bio Inc.
CORRESP 1 filename1.htm CORRESP Q32 Bio Inc. 830 Winter Street Waltham, MA 02451 April 25, 2024 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance – Office of Life Sciences 100 F Street, N.E. Washington, D.C. 20549 Re: Q32 Bio Inc. Registration Statement on Form S-1 File No. 333-278829 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Q32 Bio Inc. (the “Company”) hereby requests acceleration of the effective date of its Registration Statement on Form S-1 (File No. 333-278829) (the “Registration Statement”), so that it may become effective at 4:00 pm Eastern time on April 29, 2024, 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. If you have any questions regarding this request, please contact Sarah Ashfaq of Goodwin Procter LLP at (212) 459-7238. Very truly yours, Q32 BIO INC. By: /s/ Jodie Morrison Name: Jodie Morrison Title: Chief Executive Officer cc: Sarah Ashfaq, Goodwin Procter LLP
2024-04-25 - UPLOAD - Q32 Bio Inc. File: 333-278829
United States securities and exchange commission logo
April 25, 2024
Jodie Morrison
Chief Executive Officer
Q32 Bio Inc.
830 Winter Street
Waltham, MA 02451
Re:Q32 Bio Inc.
Registration Statement on Form S-1
Filed April 19, 2024
File No. 333-278829
Dear Jodie Morrison:
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: Sarah Ashfaq, Esq.
2024-02-13 - CORRESP - Q32 Bio Inc.
CORRESP 1 filename1.htm CORRESP Homology Medicines, Inc. One Patriots Park Bedford, MA 01730 February 13, 2024 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, NE Washington, D.C. 20549 Re: Homology Medicines, Inc. Registration Statement on Form S-4 Originally Filed December 18, 2023 (File No. 333-276093) Ladies and Gentlemen: 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 acceleration of the effective date of the above-referenced Registration Statement on Form S-4 so that it will become effective as of 2:00 p.m., Eastern Time, on February 14, 2024, or as soon thereafter as practicable, or at such later time as Homology Medicines, Inc. (the “Company”) or its counsel may request via telephone call to the Staff. Please contact Elisabeth M. Martin of Latham & Watkins LLP at (617) 948-6018 to provide notice of effectiveness, or if you have any other questions or concerns regarding this matter. Sincerely yours, Homology Medicines, Inc. By: /s/ Paul Alloway, Ph.D. Name: Paul Alloway, Ph.D. Title: President and Chief Operating Officer cc: Elisabeth M. Martin, Esq., Latham & Watkins LLP Peter N. Handrinos, Esq., Latham & Watkins LLP Leah R. Sauter, Esq., Latham & Watkins LLP
2024-02-12 - CORRESP - Q32 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 Austin Milan Beijing Munich Boston New York Brussels Orange County Century City Paris Chicago Riyadh February 12, 2024 Dubai San Diego Düsseldorf San Francisco Frankfurt Seoul Hamburg Silicon Valley Hong Kong Singapore Houston Tel Aviv London Tokyo VIA EDGAR DELIVERY Los Angeles Washington, D.C. Madrid United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: Cindy Polynice Joe McCann Tracie Mariner Angela Connell Re: Homology Medicines, Inc. Amendment No. 1 to Registration Statement on Form S-4 Filed January 29, 2024 File No. 333-276093 Ladies and Gentlemen: On behalf of Homology Medicines, 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 February 9, 2024 (the “Comment Letter”) with respect to the Company’s Amendment No. 1 to Registration Statement on Form S-4, as filed on January 29, 2024 (“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. February 12, 2024 Page 2 Amendment No. 1 to Form S-4 Filed January 29, 2024 Cover Page 1. We note your response to our prior comment 1. Given that the Nasdaq listing condition is waivable, please further revise your disclosure to indicate whether recirculation or resolicitation of shareholders will occur prior to the vote if the listing application is not approved but the condition is waived. If Homology shareholders will not have certainty regarding the listing of the combined company’s shares at the time they are asked to vote, please clarify this fact. Please also provide risk factor disclosure that addresses the potential consequences of the parties waiving the condition and the closing occurring without the Nasdaq listing, including but not limited to the liquidity implications thereof. Response: In response to the Staff’s comment, the Company has revised the disclosure on the cover page and on pages 45 and 189 of Amendment No. 2. Homology is currently subject to securities class action litigation and may be subject to similar..., page 79 2. We note your response to our prior comment 11 and reissue in part. Please revise your disclosure to clarify whether damage awards could impact CVR payments. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 79 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) 948-6018 with any questions or comments regarding this correspondence. Very truly yours, /s/ Elisabeth M. Martin Elisabeth M. Martin of LATHAM & WATKINS LLP cc: Paul Alloway, Ph.D., President and Chief Operating Officer, Homology Medicines, Inc. Jodie Morrison, President and Chief Executive Officer, Q32 Bio Inc. Peter N. Handrinos, Esq., Latham & Watkins LLP Leah R. Sauter, Esq., Latham & Watkins LLP Kingsley L. Taft, Esq., Goodwin Procter LLP Sarah Ashfaq, Esq., Goodwin Procter LLP
2024-02-09 - UPLOAD - Q32 Bio Inc. File: 333-276093
United States securities and exchange commission logo
February 9, 2024
Paul Alloway, Ph.D.
President and Chief Operating Officer
Homology Medicines, Inc.
One Patriots Park
Bedford, MA 01730
Re:Homology Medicines, Inc.
Amendment No.1 to Registration Statement on Form S-4
Filed January 29, 2024
File No. 333-276093
Dear Paul Alloway:
We have reviewed your amended registration statement and have the following
comments.
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 January 19, 2024 letter.
Amendment No. 1 to Form S-4 Filed January 29, 2024
Cover Page
1.We note your response to our prior comment 1. Given that the Nasdaq listing condition is
waivable, please further revise your disclosure to indicate whether recirculation or
resolicitation of shareholders will occur prior to the vote if the listing application is not
approved but the condition is waived. If Homology shareholders will not have certainty
regarding the listing of the combined company's shares at the time they are asked to vote,
please clarify this fact. Please also provide risk factor disclosure that addresses the
potential consequences of the parties waiving the condition and the closing occurring
without the Nasdaq listing, including but not limited to the liquidity implications thereof.
FirstName LastNamePaul Alloway, Ph.D.
Comapany NameHomology Medicines, Inc.
February 9, 2024 Page 2
FirstName LastName
Paul Alloway, Ph.D.
Homology Medicines, Inc.
February 9, 2024
Page 2
Homology is currently subject to securities class action litigation and may be subject to similar...,
page 79
2.We note your response to our prior comment 11 and reissue in part. Please revise your
disclosure to clarify whether damage awards could impact CVR payments.
Please contact Tracie Mariner at 202-551-3744 or Angela Connell at 202-551-3426 if you
have questions regarding comments on the financial statements and related matters. Please
contact Cindy Polynice at 202-551-8707 or Laura Crotty at 202-551-7614 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Lisa Martin, Esq.
2024-01-26 - CORRESP - Q32 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 Austin Milan Beijing Munich Boston New York Brussels Orange County Century City Paris Chicago Riyadh January 26, 2024 Dubai San Diego Düsseldorf San Francisco Frankfurt Seoul Hamburg Silicon Valley Hong Kong Singapore Houston Tel Aviv London Tokyo VIA EDGAR DELIVERY Los Angeles Washington, D.C. Madrid United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: Cindy Polynice Joe McCann Tracie Mariner Angela Connell Re: Homology Medicines, Inc. Registration Statement on Form S-4 Originally Filed December 18, 2023 File No. 333-276093 Ladies and Gentlemen: On behalf of Homology Medicines, 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 January 19, 2024 (the “Comment Letter”) with respect to the Company’s Registration Statement on Form S-4, as filed on December 18, 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. January 26, 2024 Page 2 Registration Statement on Form S-4 filed December 18, 2023 Cover Page 1. Please revise the Letter to Stockholders to prominently disclose, if true, whether the listing approval for Q32’s securities on NASDAQ is a closing condition of the merger. Response: In response to the Staff’s comment, the Company has revised the disclosure on the cover page of Amendment No. 1. 2. Please revise the Letter to Stockholders to disclose the valuations assigned to Homology and Q32 for purposes of this merger. Response: In response to the Staff’s comment, the Company has revised the disclosure on the cover page of Amendment No. 1. Questions and Answers, page 2 3. Please revise this section, where appropriate, as well as the Prospectus Summary, to disclose Homology’s net cash as of the most recent practicable date and briefly describe the factors that could affect Homology’s net cash between this date and the closing date of the merger Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 2 and 15 of Amendment No. 1. What is the Merger?, page 2 4. Please revise to disclose and, if necessary, explain the Exchange Ratio. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 2 of Amendment No. 1. What are the CVRs being issued to Homology stockholders?, page 5 5. With reference to Exhibit 10.5, please revise this Q&A or add a new one to explain that Q32 must use commercially reasonable efforts to sell the legacy assets and discuss the level of efforts and resources required. Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 6, 24 and 219 of Amendment No. 1. Prospectus Summary, page 13 6. Please shorten the ADX-097 pipeline arrow given that the Phase 1 appears to be on-going. January 26, 2024 Page 3 Response: The Company respectfully advises the Staff that the Phase 1 clinical trial of ADX-097 has been completed. In response to the Staff’s comment, the Company has revised the disclosure on pages 14, 112 and 311 of Amendment No. 1 to clarify that such trial has been completed. 7. Please revise to remove the final candidate from the table. In this regard, we note that both the discovery phase program and the indication are unidentified. Response: In response to the Staff’s comment, the Company has revised the pipeline table on pages 15 and 312 of Amendment No. 1. 8. Please revise your pipeline table to include the information for footnote 2 or advise. Response: In response to the Staff’s comment, the Company has revised the pipeline table on pages 15 and 312 of Amendment No. 1. Opinion of Homology’s Financial Advisor, page 17 9. Please revise to explain why Homology’s Board sought a fairness opinion concerning the $195 million Q32 Equity Value as opposed to one that addressed the fairness of the Merger exchange ratio. Revise to clarify, if true, that the advisor did not assess whether the $80 million Homology Equity Value of Homology was fair from a financial point of view to the Homology stockholders. Discuss how Homology’s Board assessed this valuation in rending its recommendation to shareholders. Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 18, 163 and 169 of Amendment No. 1. Following the Merger, the combined company may be unable to integrate successfully…, page 36 10. Please reconcile this risk factor disclosure with your disclosure on page 2 and elsewhere indicating that the business of Q32 will continue as the business of the combined company. Response: In response to the Staff’s comment, the Company has deleted the risk factor disclosure on page 37 of Amendment No. 1. Homology is currently subject to securities class action litigation…, page 77 11. Please revise to address whether future damages in excess of insurance coverage will be borne by the combined company and its shareholders. In this regard, clarify whether damage awards could impact CVR payments. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 79 of Amendment No. 1. The Company notes for the Staff that damages awards January 26, 2024 Page 4 will not impact CVR payments under the CVR Agreement. A separate risk factor explains that the CVRs will be unsecured obligations of the combined company and all payments under the CVRs, all other obligations under the CVR Agreement and the CVRs and any rights or claims relating thereto may be subordinated in right of payment to the prior payment in full of all current or future senior obligations of the combined company. Background of the Merger, page 153 12. Please revise your disclosure on page 154 to explain the basis on which Homology narrowed the field down to the 6 initial bidders. Also describe what factors the Homology board took into consideration in selecting Q32 as the lead potential counterparty. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 157 of Amendment No. 1. The Company respectfully advises the Staff that as disclosed on page 159 of Amendment No. 1, the Homology Board selected Q32 as the lead potential counterparty and Bidder F as the primary backup counterparty, based on, among other things, the relative valuations of Homology and the respective counterparties as well as the underlying business cases proposed by such counterparties. 13. Please revise to discuss the negotiations and revisions relating to the CVRs, including those pertaining to the definition of commercially reasonable efforts. It should be clear how the terms evolved over time and the positions of the two parties. Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 161 and 162 of Amendment No. 1. 14. Please revise the October 16 entry to identify the items included in the supplemental request. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 161 of Amendment No. 1. 15. With reference to the October 12 and November 9 entries, please revise to explain the material changes to the Q32 financial models during the course of the negotiations. Please revise to discuss what consideration the Homology Board gave to negotiating the $195 million Q32 Equity Value downward in light of Q32’s inability to identify sufficient demand to pursue a $75 million PIPE financing led by its current investors. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 162 of Amendment No. 1. Financial Analyses, page 169 16. Please revise your disclosure regarding TD Cowen’s DCF analysis to disclose why cash flows for a 26-year period were used instead of a shorter period. Response: The Company respectfully advises the Staff that as disclosed on page 172 of Amendment No. 1, cash flows for a 26-year period were used instead of a shorter period in order to capture Q32’s cash flows through profitability and loss of regulatory and patent exclusivity based on the Q32 forecasts. January 26, 2024 Page 5 Certain Unaudited Financial Projections for Q32, page 171 17. Please revise page 173 to also present the unadjusted projections that Q32’s management provided to Homology. Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 175 and 176 of Amendment No. 1. Material U.S. Federal Income Tax Consequences of the Merger, page 220 18. Please revise to add a section that discusses the material tax consequences of the Merger to the Homology stockholders, or advise. With reference to Staff Legal Bulletin No. 19, please provide a tax opinion of counsel, as applicable. Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 8 and 228 of Amendment No. 1. With respect to the reorganization opinion, the Company has revised the disclosure on page 457 of Amendment No.1 in response to the Staff’s comment. In addition, the Company advises the Staff that counsel to Q32 will deliver an opinion with respect to the qualification of the merger as a “reorganization” within the meaning of Section 368(a) of the Code, and such opinion will be filed by amendment to the Registration Statement. Matters Being Submitted to a Vote of Homology Stockholders, page 233 19. We note your disclosure in Proposal No. 3 stating that you are proposing an amendment to the Restated Certificate of Incorporation to give the Homology’s board of directors discretionary authority to effect a Reverse Stock Split of Homology’s issued and outstanding common stock. Please revise to disclose the range of this reverse stock split. Further, to the extent that any such reverse stock split is expected to occur prior to the effectiveness of your registration statement, all share data will require retroactive adjustment pursuant to SAB Topic 4.C. Response: The Company has revised the disclosure on the cover page and on pages 39, 229, 238, 239 and 242 of Amendment No. 1 to disclose the range of the reverse stock split. The Company advises the Staff that the reverse stock split is expected to occur subsequent to the effectiveness of the Registration Statement and therefore the Company has not retroactively adjusted the per share data. Q32’s Business, page 305 20. Please revise your disclosure to provide a narrative description explaining the results in the graphs on page 311 so it is clear how the results support the claims in this section. January 26, 2024 Page 6 Response: In response to the Staff’s comment, the Company has revised the disclosure on page 317 of Amendment No. 1. Future Funding Requirements, page 378 21. With reference to the pro forma balance sheet on page 401, please revise to discuss the combined company’s plans for the funds it will hold post-merger, including the approximate amount intended for each purpose. Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 375 and 376 of Amendment No. 1. Unaudited Pro Forma Condensed Combined Financial Information Notes to the Unaudited Pro Forma Condensed Consolidated Financial Information 1. Description of the Transaction, page 404 22. We note your disclosure that the number and value of the shares of Homology common stock and options to purchase Homology common stock to be held by Homology stockholders to be outstanding following the Merger and the fair value of the CVRs will not be determined until the completion of the Merger and therefore, the final aggregate value of the consideration paid in the Merger may be more or less than $45.3 million. We further note that the ownership percentages are subject to adjustment to the extent that Homology’s net cash of the closing is less than $59.5 million or greater than $60.5 million. Please tell us your consideration of including a sensitivity analysis of the merger consideration. Response: In response to the Staff’s comment, the Company has revised the disclosure on page 412 of Amendment No. 1. Unaudited Pro Forma Condensed Combined Financial Information Notes to the Unaudited Pro Forma Condensed Consolidated Financial Information 4. Pro Forma Adjustments, page 407 23. We note your disclosure in Note H stating, “The estimated fair value of the CVR is $14.3 million, which is the fair value of the estimated cash dividend expected to be paid.” Please expand your disclosure to explain how this amount was determined. Response: In response to the Staff’s comment, the Company has revised the disclosure on pages 414 and 416 of Amendment No. 1. January 26, 2024 Page 7 General 24. With reference to your disclosures concerning the current status of Homology Medicines, Inc.’s operations, the plans for those operations, and the pro forma accounting treatment for Homology Medicines’ assets and liabilities on page 404, please provide us an analysis concerning whether Homology Medicines is a shell company as defined in Rule 12b-2 of the Exchange Act or whether it could become one prior to Closing. For guidance, 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. Response: The Company respectfully advises the Staff that as of September 30, 2023, Homology did not meet the Commission’s definition of a shell company because it had significant pre-combination assets and/or activities, including multiple clinical and pre-clinical development programs, a robust intellectual property portfolio and a research and development team, prior to its decision to seek strategic alternatives. Rule 12b-2 of the Securities Exchange Act of 1934, as amended, defines a “shell company” as a registrant that has: (1) No or nominal operations; and (2) Either: (i) no or nominal assets; (ii) assets consisting solely of cash and cash equivalents; or (iii) assets consisting of any amount of cash and cash equivalents and nominal other assets. Homology is a clinical-stage genetic medicines company historically focused on transforming the lives of patients suffering from rare genetic diseases with significant unmet medical needs by addressing the underlying cause of the disease. Homology has a proprietary platform designed to utilize its AAVHSCs to precisely and efficiently deliver single administration genetic medicines in vivo through a nuclease-free gene editing modality, gene therapy, or gene therapy to express antibodies platform, which is designed to produce antibodies throughout the body. Until July 2023, Homology had multiple clinical and pre-clinical development programs that it was pursuing internally. As described in the Registration Statement, in July 2023, following a review of its business, Homology’s board of direct
2024-01-22 - UPLOAD - Q32 Bio Inc. File: 333-276093
United States securities and exchange commission logo
January 19, 2024
Paul Alloway, Ph.D.
President and Chief Operating Officer
Homology Medicines, Inc.
One Patriots Park
Bedford, MA 01730
Re:Homology Medicines, Inc.
Registration Statement on Form S-4
Filed December 18, 2023
File No. 333-276093
Dear Paul Alloway:
We have reviewed your registration statement and have the following comments.
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-4 Filed December 18, 2023
Cover Page
1.Please revise the Letter to Stockholders to prominently disclose, if true, whether the listing
approval for Q32's securities on NASDAQ is a closing condition of the merger.
2.Please revise the Letter to Stockholders to disclose the valuations assigned to Homology
and Q32 for purposes of this merger.
Questions and Answers, page 2
3.Please revise this section, where appropriate, as well as the Prospectus Summary, to
disclose Homology's net cash as of the most recent practicable date and briefly describe
the factors that could affect Homology's net cash between this date and the closing date of
the merger.
FirstName LastNamePaul Alloway, Ph.D.
Comapany NameHomology Medicines, Inc.
January 19, 2024 Page 2
FirstName LastName
Paul Alloway, Ph.D.
Homology Medicines, Inc.
January 19, 2024
Page 2
What is the Merger?, page 2
4.Please revise to disclose and, if necessary, explain the Exchange Ratio.
What are the CVRs being issued to Homology stockholders?, page 5
5.With reference to Exhibit 10.5, please revise this Q&A or add a new one to explain that
Q32 must use commercially reasonable efforts to sell the legacy assets and discuss the
level of efforts and resources required.
Prospectus Summary , page 13
6.Please shorten the ADX-097 pipeline arrow given that the Phase 1 appears to be on-going.
7.Please revise to remove the final candidate from the table. In this regard, we note that
both the discovery phase program and the indication are unidentified.
8.Please revise your pipeline table to include the information for footnote 2 or advise.
Opinion of Homology's Financial Advisor, page 17
9.Please revise to explain why Homology’s Board sought a fairness opinion concerning the
$195 million Q32 Equity Value as opposed to one that addressed the fairness of the
Merger exchange ratio. Revise to clarify, if true, that the advisor did not assess whether
the $80 million Homology Equity Value of Homology was fair from a financial point of
view to the Homology stockholders. Discuss how Homology’s Board assessed this
valuation in rending its recommendation to shareholders.
Following the Merger, the combined company may be unable to integrate successfully..., page 36
10.Please reconcile this risk factor disclosure with your disclosure on page 2 and elsewhere
indicating that the business of Q32 will continue as the business of the combined
company.
Homology is currently subject to securities class action litigation..., page 77
11.Please revise to address whether future damages in excess of insurance coverage will be
borne by the combined company and its shareholders. In this regard, clarify whether
damage awards could impact CVR payments.
Background of the Merger, page 153
12.Please revise your disclosure on page 154 to explain the basis on which Homology
narrowed the field down to the 6 initial bidders. Also describe what factors the Homology
board took into consideration in selecting Q32 as the lead potential counterparty.
13.Please revise to discuss the negotiations and revisions relating to the CVRs, including
those pertaining to the definition of commercially reasonable efforts. It should be clear
FirstName LastNamePaul Alloway, Ph.D.
Comapany NameHomology Medicines, Inc.
January 19, 2024 Page 3
FirstName LastName
Paul Alloway, Ph.D.
Homology Medicines, Inc.
January 19, 2024
Page 3
how the terms evolved over time and the positions of the two parties.
14.Please revise the October 16 entry to identify the items included in the supplemental
request.
15.With reference to the October 12 and November 9 entries, please revise to explain the
material changes to the Q32 financial models during the course of the negotiations.
Please revise to discuss what consideration the Homology Board gave to negotiating the
$195 million Q32 Equity Value downward in light of Q32’s inability to identify sufficient
demand to pursue a $75 million PIPE financing led by its current investors.
Financial Analyses, page 169
16.Please revise your disclosure regarding TD Cowen's DCF analysis to disclose why cash
flows for a 26-year period were used instead of a shorter period.
Certain Unaudited Financial Projections for Q32, page 171
17.Please revise page 173 to also present the unadjusted projections that Q32’s management
provided to Homology.
Material U.S. Federal Income Tax Consequences of the Merger, page 220
18.Please revise to add a section that discusses the material tax consequences of the Merger
to the Homology stockholders, or advise. With reference to Staff Legal Bulletin No. 19,
please provide a tax opinion of counsel, as applicable.
Matters Being Submitted to a Vote of Homology Stockholders, page 233
19.We note your disclosure in Proposal No. 3 stating that you are proposing an amendment to
the Restated Certificate of Incorporation to give the Homology’s board of directors
discretionary authority to effect a Reverse Stock Split of Homology’s issued and
outstanding common stock. Please revise to disclose the range of this reverse stock split.
Further, to the extent that any such reverse stock split is expected to occur prior to the
effectiveness of your registration statement, all share data will require retroactive
adjustment pursuant to SAB Topic 4.C.
Q32's Business, page 305
20.Please revise your disclosure to provide a narrative description explaining the results in
the graphs on page 311 so it is clear how the results support the claims in this section.
Future Funding Requirements, page 378
21.With reference to the pro forma balance sheet on page 401, please revise to discuss the
combined company’s plans for the funds it will hold post-merger, including the
approximate amount intended for each purpose.
FirstName LastNamePaul Alloway, Ph.D.
Comapany NameHomology Medicines, Inc.
January 19, 2024 Page 4
FirstName LastName
Paul Alloway, Ph.D.
Homology Medicines, Inc.
January 19, 2024
Page 4
Unaudited Pro Forma Condensed Combined Financial Information
Notes to the Unaudited Pro Forma Condensed Combined Financial Information
1. Description of the Transaction, page 404
22.We note your disclosure that the number and value of the shares of Homology common
stock and options to purchase Homology common stock to be held by Homology
stockholders to be outstanding following the Merger and the fair value of the CVRs will
not be determined until the completion of the Merger and therefore, the final aggregate
value of the consideration paid in the Merger may be more or less than $45.3 million. We
further note that the ownership percentages are subject to adjustment to the extent that
Homology's net cash of the closing is less than $59.5 million or greater than $60.5 million.
Please tell us your consideration of including a sensitivity analysis of the merger
consideration.
Unaudited Pro Forma Condensed Combined Financial Information
Notes to the Unaudited Pro Forma Condensed Combined Financial Information
4. Pro Forma Adjustments, page 407
23.We note your disclosure in Note H stating, "The estimated fair value of the CVR is $14.3
million, which is the fair value of the estimated cash dividend expected to be paid."
Please expand your disclosure to explain how this amount was determined.
General
24.With reference to your disclosures concerning the current status of Homology Medicines,
Inc.’s operations, the plans for those operations, and the pro forma accounting treatment
for Homology Medicines' assets and liabilities on page 404, please provide us an analysis
concerning whether Homology Medicines is a shell company as defined in Rule 12b-2 of
the Exchange Act or whether it could become one prior to Closing. For guidance, 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.
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.
FirstName LastNamePaul Alloway, Ph.D.
Comapany NameHomology Medicines, Inc.
January 19, 2024 Page 5
FirstName LastName
Paul Alloway, Ph.D.
Homology Medicines, Inc.
January 19, 2024
Page 5
Please contact Tracie Mariner at 202-551-3744 or Angela Connell at 202-551-3426 if you
have questions regarding comments on the financial statements and related matters. Please
contact Cindy Polynice at 202-551-8707 or Joe McCann at 202-551-6262 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Lisa Martin, Esq.
2023-03-16 - CORRESP - Q32 Bio Inc.
CORRESP 1 filename1.htm CORRESP HOMOLOGY MEDICINES, INC. One Patriots Park Bedford, Massachusetts 01730 March 16, 2023 VIA EDGAR TRANSMISSION Securities and Exchange Commission Division of Corporation Finance Mail Stop 3010 100 F Street, N.E. Washington, D.C. 20549 Attention: Arzhang Navai Re: HOMOLOGY MEDICINES, INC. Registration Statement on Form S-3 (Registration No. 333-270414) 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- 270414) (the “Registration Statement”) of Homology Medicines, Inc. (the “Company”). We respectfully request that the Registration Statement become effective as of 4:00 p.m., Eastern Time, on March 17, 2023, 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 Peter Handrinos at (617) 948-6060 or Wesley Holmes at (617) 948-6027. If you have any questions regarding the foregoing, please do not hesitate to contact Peter Handrinos at (617) 948-6060 or Wesley Holmes at (617) 948-6027, of Latham & Watkins LLP. Thank you in advance for your consideration. Very truly yours, HOMOLOGY MEDICINES, INC. By: /s/ W. Bradford Smith Name: W. Bradford Smith Title: Chief Financial Officer cc: Peter N. Handrinos, Latham & Watkins LLP Wesley C. Holmes, Latham & Watkins LLP
2023-03-14 - UPLOAD - Q32 Bio Inc.
United States securities and exchange commission logo
March 14, 2023
Paul Alloway
General Counsel
Homology Medicines, Inc.
One Patriots Park
Bedford, Massachusetts 01730
Re:Homology Medicines, Inc.
Registration Statement on Form S-3
Filed March 9, 2023
File No. 333-270414
Dear Paul Alloway:
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 Arzhang Navai at 202-551-4676 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Wesley Holmes
2019-04-08 - CORRESP - Q32 Bio Inc.
CORRESP 1 filename1.htm CORRESP HOMOLOGY MEDICINES, INC. One Patriots Park Bedford, Massachusetts 01730 April 8, 2019 VIA EDGAR TRANSMISSION Securities and Exchange Commission Division of Corporation Finance Mail Stop 3010 100 F Street, N.E. Washington, D.C. 20549 Attention: Christine Westbrook Re: HOMOLOGY MEDICINES, INC. Registration Statement on Form S-3 (Registration No. 333-230664) 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. 333-230664) (the “Registration Statement”) of Homology Medicines, Inc. (the “Company”). We respectfully request that the Registration Statement become effective as of 4:00 p.m., Eastern Time, on April 9, 2019, 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 Peter Handrinos at (617) 948-6060 or Wesley Holmes at (212) 906-1366. If you have any questions regarding the foregoing, please do not hesitate to contact Peter Handrinos at (617) 948-6060 or Wesley Holmes at (212) 906-1366, of Latham & Watkins LLP. Thank you in advance for your consideration. Very truly yours, HOMOLOGY MEDICINES, INC. By: /s/ Bradford Smith Name: Bradford Smith Title: Chief Financial Officer cc: Peter N. Handrinos, Latham & Watkins LLP Wesley C. Holmes, Latham & Watkins LLP
2019-04-08 - UPLOAD - Q32 Bio Inc.
April 8, 2019
Arthur O. Tziannabos
President and Chief Executive Officer
Homology Medicines, Inc.
One Patriots Park
Bedford, MA 01730
Re:Homology Medicines, Inc.
Registration Statement on Form S-3
Filed April 1, 2019
File No. 333-230664
Dear Dr. Tziannabos:
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 Christine Westbrook at 202-551-5019 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Wesley C. Holmes, Esq.
2018-03-23 - CORRESP - Q32 Bio Inc.
CORRESP
1
filename1.htm
CORRESP
March 23, 2018
Securities and Exchange Commission
100 F Street, N.E.
Washington, D.C. 20549
Re:
Homology Medicines, Inc.
Registration Statement on Form S-1 (as amended) (SEC File No. 333-223409)
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 Homology Medicines, Inc. that the effective date of the Registration Statement be
accelerated so that it will be declared effective at 4:00 p.m., New York City time, on March 27, 2018, or as soon thereafter as practicable.
Pursuant to
Rule 460 under the Act, please be advised that we have distributed approximately 870 copies of the Preliminary Prospectus dated March 19, 2018 through the date hereof, to underwriters, dealers, institutions and others, and are in the process of
redistributing the preliminary prospectus dated March 23, 2018 (the “Preliminary Prospectus”) to those investors as well.
In connection with
the Preliminary Prospectus distribution for the above-referenced issue, the prospective underwriters have confirmed that they are complying with the 48-hour requirement in Rule
15c2-8(b) under the Securities Exchange Act of 1934, as amended.
Very truly yours,
MERRILL LYNCH, PIERCE, FENNER & SMITH
INCORPORATED
COWEN AND COMPANY, LLC
EVERCORE GROUP L.L.C.
As Representatives of the several
underwriters
[SIGNATURE PAGES FOLLOW]
MERRILL LYNCH, PIERCE, FENNER & SMITH
INCORPORATED
By:
/s/ Anurag Jindal
Name: Anurag Jindal
Title: Managing
Director
COWEN AND COMPANY, LLC
By:
/s/ Bill Follis
Name: Bill Follis
Title: Managing
Director
EVERCORE GROUP L.L.C.
By:
/s/ Maren Winnick
Name: Maren Winnick
Title: Managing
Director
As representatives of the several underwriters.
[Signature Page to Acceleration Request Letter]
2018-03-23 - CORRESP - Q32 Bio Inc.
CORRESP 1 filename1.htm CORRESP March 23, 2018 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: Mr. Jeffrey Gabor Re: Homology Medicines, Inc. Registration Statement on Form S-1 Filed March 2, 2018 Registration No. 333-223409 Dear Mr. Gabor: 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 March 27, 2018, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, or at such later time as Homology Medicines, Inc. (the “Company”) or its counsel may request via telephone call to the staff. Please contact Wesley Holmes of Latham & Watkins LLP, counsel to the Company, at (212) 906-1366, or in his absence, Peter Handrinos at (617) 948-6060, to provide notice of effectiveness, or if you have any other questions or concerns regarding this matter. Sincerely yours, Homology Medicines, Inc. By: /s/ Arthur O. Tzianabos, Ph.D. Arthur O. Tzianabos, Ph.D. President and Chief Executive Officer cc: Peter N. Handrinos, Esq. Wesley C. Holmes, Esq.
2018-03-14 - CORRESP - Q32 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
March 14, 2018
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
Rome
San Diego
San Francisco
Seoul
Shanghai
Silicon Valley
Singapore
Tokyo
Washington, D.C.
VIA EDGAR AND HAND DELIVERY
CONFIDENTIAL
FOIA Confidential Treatment Request
Under 17 C.F.R. §200.83
Securities and Exchange Commission
Division of Corporation Finance
Office of Healthcare &
Insurance
100 F Street, N.E.
Mail Stop 4720
Washington, D.C. 20549
Attention: Mr. Jeffrey Gabor
Re:
Homology Medicines, Inc. | Anticipated Price Range
Registration Statement on Form S-1 (File No. 333-223409)
Dear Mr. Gabor:
On behalf of Homology
Medicines, 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 originally submitted the above-referenced Registration Statement (the “Registration Statement”) to the Commission on December 22, 2017. The purpose of this letter is to
respond to an outstanding comment relating to stock-based compensation and beneficial conversion features that was provided to the Company in a letter from the Staff dated January 19, 2018, as well as to provide proposed responses to a comment
from the Staff received by letter dated March 6, 2018, also related to the Registration Statement. 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 this 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.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED BY HOMOLOGY MEDICINES, INC.
Securities and Exchange Commission
March 14, 2018
Page
2
Comment 4 (January 19, 2018):
Once you have an estimated offering price or range, please provide us an analysis explaining the reasons for the 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.
ESTIMATED IPO PRICE RANGE
To assist the
Staff in its review, the Company advises the Staff that, although not yet reflected in the Registration Statement, based on discussions with the Company’s board of directors and reflecting input from the lead underwriters (the
“Underwriters”) for the Company’s initial public offering (“IPO”), if the Company were to commence marketing of the transaction today, the Company presently anticipates that the estimated price
range would be approximately $[***] to $[***] per share for the Company’s common stock (the “Preliminary IPO Price Range”) with a midpoint of the anticipated range of approximately $[***] per share (the
“Preliminary Assumed IPO Price”). The Preliminary IPO Price Range and Preliminary Assumed IPO Price do not reflect the reverse stock split that the Company intends to effect prior to the Commission’s declaration of
effectiveness of the Registration Statement.1 The Company advises the Staff that the final range to be included in a pre-effective amendment to the
Registration Statement, after giving effect to an appropriate reverse stock split, will include a price range of no more than $2.00, if the maximum price is $10.00 per share or less, or 20%, if the maximum price is greater than $10.00 per share,
unless otherwise approved by the Staff.
The Company’s final post-split Preliminary IPO Price Range 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.
ANALYSIS OF STOCK OPTION GRANTS IN PRECEDING 12 MONTHS
The following table summarizes by grant date the number of shares of common stock underlying stock options granted during the past year, as
well as the associated per share exercise price and the estimated fair value per share of the Company’s common stock on the date of option grant, and the estimated fair value of options per share used to determine stock-based compensation
expense for financial reporting purposes.
Grant Date
Number of
Shares
Underlying
Stock Options
Granted
Per Share
Exercise Price of
Options
Estimated
Fair Value of
Common Stock
per Share on Date
of Option Grant
Per Share
Estimated Fair
Value of Options
September 7, 2017
661,500
$0.55
$0.55
$0.29
December 7, 2017
4,991,496
$1.26
$1.26
$0.67
The Company expects that additional option grants made prior to the offering shall have an exercise price
equal to the initial public offering price per share for shares of common stock sold in the offering pursuant to the Registration Statement.
1
The Company intends to effect a reverse stock split of one-for-[***] shares of common stock prior to the Commission’s declaration of effectiveness of the Registration Statement.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED BY HOMOLOGY MEDICINES, INC.
Securities and Exchange Commission
March 14, 2018
Page
3
The Company’s discussion of
stock-based compensation for financial reporting purposes is primarily contained within the section of the Registration Statement entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations—Critical
Accounting Policies and Use of Estimates—Stock-Based Compensation,” which is included on pages 83 and 84 of the Registration Statement. As disclosed, the Company’s board of directors has estimated the fair value of the
Company’s common stock at various grant dates, with input from management, considering the Company’s most recently available third-party valuations of the common stock and the board of directors’ assessment of additional objective and
subjective factors that it believed were relevant, including:
•
the prices at which the Company sold shares of preferred stock and the superior rights and preferences of the preferred stock relative to the Company’s common stock at the time of each grant;
•
the progress of the Company’s research and development programs, including the status and results of preclinical studies for the Company’s product candidates;
•
the Company’s stage of development and commercialization and business strategy;
•
external market conditions affecting the life sciences industry and trends within the life sciences industry;
•
the Company’s financial position, including cash on hand, and the Company’s historical and forecasted performance and operating results;
•
the lack of an active public market for the Company’s common stock and the Company’s preferred stock;
•
the likelihood of achieving a liquidity event, such as an IPO or sale of the Company in light of prevailing market conditions; and
•
the analysis of IPOs and the market performance of similar companies in the life sciences industry.
Common Stock Valuation Methodologies
The Company’s determination of the fair value of common stock was performed using methodologies, approaches and assumptions consistent
with the American Institute of Certified Public Accountants’ Accounting and Valuation Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. The Company’s common stock valuations were performed using
option-pricing method (“OPM”) or a hybrid of the probability-weighted expected return method (“PWERM”) and the OPM, which the Company refers to as the hybrid method. Each of the methods is described as
follows:
•
OPM. The OPM treats common stock and preferred stock as call options on the total equity value of a
company, with exercise prices based on the value thresholds at which
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED BY HOMOLOGY MEDICINES, INC.
Securities and Exchange Commission
March 14, 2018
Page
4
the allocation among the various holders of a company’s securities changes. Under this method, the common stock has value only if the funds available for distribution to stockholders exceed the value of the liquidation
preferences at the time of a liquidity event, such as a strategic sale or merger. The common stock is modeled as a call option on the underlying equity value at a predetermined exercise price. In the model, the exercise price is based on a
comparison with the total equity value rather than, as in the case of a regular call option, a comparison with a per share stock price. Thus, common stock is considered to be a call option with a claim on the enterprise at an exercise price equal to
the remaining value immediately after the preferred stock liquidation preference is paid.
The OPM uses the Black-Scholes
option-pricing model to price the call options. This model defines the fair values of securities as functions of the current fair value of a company and uses assumptions such as the anticipated timing of a potential liquidity event and the estimated
volatility of the equity securities.
•
PWERM. Under the PWERM methodology, the fair value of common stock is estimated based upon an analysis of future values for the Company, assuming various outcomes. The common stock value is based on the
probability-weighted present value of expected future investment returns considering each of the possible outcomes available as well as the rights of each class of stock. The future value of the common stock under each outcome is discounted back to
the valuation date at an appropriate risk-adjusted discount rate and probability weighted to arrive at an indication of value for the common stock.
•
Hybrid method. The hybrid method is a PWERM where the equity value in one of the scenarios is calculated using an OPM. In the hybrid method used by the Company, two types of future-event scenarios were
considered: an IPO scenario and a sale scenario. The enterprise value for the IPO scenario was determined using a market approach identified in a number of recent IPO transactions in the biotechnology and pharmaceutical industry. The Company
compared the enterprise values of certain newly public companies and considered the stage of development, depth of clinical candidates in each company’s product portfolio and the number of strategic partnerships and collaboration agreements
compared to that of the Company at the time. Accordingly, the Company selected an enterprise value within the average of the Guideline Public Transactions with a focus on gene editing or gene therapy platform companies. For the market approach
scenario, the recent transaction method was selected to calculate the enterprise value of the Company. The common stock value was based on the probability-weighted present value of expected future investment returns considering each of the potential
possible outcomes available as well as the rights of each class of stock. The Company then applied a discount for lack of marketability to the common stock to account for the lack of access to an active public market.
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED BY HOMOLOGY MEDICINES, INC.
Securities and Exchange Commission
March 14, 2018
Page
5
Grant Date Fair Value
Determinations
September 7, 2017 Option Grants. The
Company’s board of directors determined that the fair value of its common stock was $0.55 per share as of September 7, 2017 based on input from management, the objective and subjective criteria discussed above and the results of its most
recent third-party valuation performed as of July 31, 2017, which was received by the Company in early-August 2017. In reaching this determination, the board of directors determined that no material changes had occurred in the business since
July 31, 2017.
The July 31, 2017 valuation analysis was performed using the hybrid method, which considered a sale scenario and
an IPO scenario, in addition to the market approach scenario, for the first time. For those future-event scenarios, the Company’s management determined that the probability for the market approach scenario was 75% and for the IPO scenario was
5%, based on the Company’s assessment of its development pipeline and market conditions. The valuation analysis also attributed a 20% probability to a sale at or below the preferred liquidation preference scenario.
In determining the enterprise value for the market approach scenario, the Company applied a recent transaction method. The market approach was
selected as the Company had recently closed a Series B Preferred round of financing. This approach priced the common stock off the Series B Preferred implied price by considering the economic and control rights of the preferred shareholders versus
common shareholders. For the sale scenario, the Company estimated time to completion for the sale as 2.3 years.
In determining the
enterprise value for the IPO scenario, the Company applied the guideline public company method under the market approach, which analyzed enterprise values at the IPO date of publicly traded life sciences companies that recently completed IPOs. For
the IPO scenario, the Company estimated time to completion for the IPO as 1.3 years and applied a risk-adjusted discount rate of 25%, which was determined based on a weighted average cost of capital model. The estimate of 1.3 years for completion of
the IPO was based on the lack of receptivity for preclinical stage companies at the time and the expectation that the Company would plan the IPO timing to be a few months before the then assumed time for filing an Investigational New Drug
(“IND”) application for its lead product candidate.
In determining the enterprise value for the low case sale at
or below liquidation preference scenario, the Company applied the guideline transaction method under the market approach, which analyzed enterprise values at the sale date of life sciences companies that recently completed acquisition transactions.
Significant current risks of the business include: the need to obtain IND approval prior to the initiation of clinical trials, future clinical trials will need to be conducted to validate the safety, efficacy, and manufacturing feasibility (due to
novel concept) of product candidates prior to potential U.S. Food and Drug Administration approval, and need for future funding in order to complete clinical trials. For the low sale at or below liquidation preference scenario, the Company estimated
time to low sale event to be two years.
For the three future-event scenarios, the Company then applied a discount for lack of
marketability of 30% under the market approach scenario and of 25% under the IPO scenario. The July 31, 2017 valuation analysis resulted in a valuation of the Company’s common stock of $0.55
CONFIDENTIAL TREATMENT HAS BEEN REQUESTED BY HOMOLOGY MEDICINES, INC.
Securities and Exchange Commission
March 14, 2018
Page
6
per share. Based on that result as well as
consideration of other qualitative factors, the Company’s board of directors determined that the fair value of the Company’s common stock was $0.55 per share as of September 7, 2017, when it granted stock options for the purchase of
661,500 shares of common stock.
December 7, 2017 Option Grants. The Company’s
board of directors determined that
2018-03-06 - UPLOAD - Q32 Bio Inc.
March 6, 2018
Arthur Tzianabos
President and Chief Executive Officer
Homology Medicines, Inc.
45 Wiggins Avenue
Bedford, MA 01730
Re:Homology Medicines, Inc.
Registration Statement on Form S-1
Filed March 2, 2018
File No. 333-223409
Dear Dr. Tzianabos:
We have reviewed 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 our comment applies to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to this comment, we may have additional comments.
Form S-1 filed March 2, 2018
Notes to Consolidated Financial Statements
Note 16. Collaboration and License Agreement, page F-27
1.Please revise to separately quantify your potential development, regulatory and
commercial milestone payments under the Novartis agreement.
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.
FirstName LastNameArthur Tzianabos
Comapany NameHomology Medicines, Inc.
June 16, 2017 Page 2
FirstName LastName
Arthur Tzianabos
Homology Medicines, Inc.
March 6, 2018
Page 2
You may contact Keira Nakada at 202-551-3659 or Angela Connell at 202-551-3426 if
you have questions regarding comments on the financial statements and related matters. Please
contact Jeffrey Gabor at 202-551-2544 or Erin Jaskot at 202-551-3442 with any other questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Wesley Holmes
2018-02-12 - UPLOAD - Q32 Bio Inc.
February 9, 2018
Arthur Tzianabos
President and Chief Executive Officer
Homology Medicines, Inc.
45 Wiggins Avenue
Bedford, MA 01730
Re:Homology Medicines, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted January 30, 2018
CIK 0001661998
Dear Dr. Tzianabos:
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 January 19, 2018 letter.
DRS on Form S-1 Submitted January 30, 2018
Prospectus Summary, page 1
1.We note your response to comment 1. Please balance your disclosure in the Summary by
clearly stating that you are a preclinical company, you have not submitted an IND for
HMI-102 or any other product candidate, and that you will require additional capital to
move beyond Phase 1/2.
FirstName LastNameArthur Tzianabos
Comapany NameHomology Medicines, Inc.
June 16, 2017 Page 2
FirstName LastName
Arthur Tzianabos
Homology Medicines, Inc.
February 9, 2018
Page 2
You may contact Keira Nakada at 202-551-3659 or Angela Connell at 202-551-3426 if
you have questions regarding comments on the financial statements and related matters. Please
contact Jeff Gabor at 202-551-2544 or Erin Jaskot at 202-551-3442 with any other questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Wesley Holmes
2018-01-19 - UPLOAD - Q32 Bio Inc.
January 19, 2018
Arthur Tzianabos
President and Chief Executive Officer
Homology Medicines, Inc.
45 Wiggins Avenue
Bedford, MA 01730
Re:Homology Medicines, Inc.
Draft Registration Statement on Form S-1
Submitted December 22, 2017
CIK No. 0001661998
Dear Dr. Tzianabos:
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.
Form DRS Submitted December 22, 2017
Prospectus Summary, page 1
1.We note your statement that you are "rapidly" advancing HMI-102 for the treatment of
phenylketonuria into a Phase 1/2 clinical trial. Please balance your disclosure by stating
here that you are a preclinical company, you have not submitted an IND for HMI-102 or
any other product candidate, and that you will require additional capital to move beyond
Phase 1/2. Please also remove the term "rapidly advancing" or tell us why you believe it
is appropriate to use this term. Please supplementally tell us why you believe you will
be to initiate a Phase 1/2 clinical trial in 2019. Please make similar disclosure in your
FirstName LastNameArthur Tzianabos
Comapany NameHomology Medicines, Inc.
June 16, 2017 Page 2
FirstName LastNameArthur Tzianabos
Homology Medicines, Inc.
January 19, 2018
Page 2
Business section.
2.We note your statement that you believe that your compelling preclinical data, scientific
expertise, product development strategy, manufacturing capabilities and robust
intellectual property position you as a leader in the development of genetic medicines.
Given the early stage of your development and the competition in this space, please
supplementally tell us the basis of your belief that you are a leader in the development of
genetic medicines.
Pipeline Table, page 5
3.Please include a column for each of Phase 1, Phase 2, and Phase 3 in your product
pipeline table here and on page 92.
Stock-Based Compensation
Critical Accounting Policies and Use of Estimates
Determination of Fair Value of Common Stock, page 81
4.Once you have an estimated offering price or range, please provide us an analysis
explaining the reasons for the 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.
Contractual Obligations and Commitments, page 86
5.Please include your obligations under the license agreements.
Business
Our Proprietary AAVHSCs, page 98
6.We note that the preclinical trials discussed in this section provide results without
providing proper context for such results. For each of the pre-clinical trials discussed in
this section, please disclose the date(s) of the trials, the sponsor and the location; scope
and size; dosage and duration; and actual results observed. Please include this disclosure
for trials you conducted as well as any third-party trials you use for comparison, such as
the AAV trials mentioned in Figure 6 or the third party studies you cite in Figure 9.
Please also state whether you have published the data for any of your preclinical studies.
Figure 5. In vivo Gene Editing, page 99
7.We note your statement that "while not illustrated, in subsequent studies at higher doses
we have observed gene correction editing efficiencies of up to 20%." Please either
provide a complete description of the study that resulted in such efficiencies, or delete
FirstName LastNameArthur Tzianabos
Comapany NameHomology Medicines, Inc.
June 16, 2017 Page 3
FirstName LastNameArthur Tzianabos
Homology Medicines, Inc.
January 19, 2018
Page 3
this statement. Please make similar revisions elsewhere that you mention this statistic,
including your prospectus summary. Please only use this statistic to the extent that it is a
balanced representation of the efficiencies you have observed in pre-clinical trials.
Competition, page 109
8.Please revise your discussion of competitive conditions by describing in greater detail the
current landscape for patent protections in your industry. In this regard, we note that
across several risk factors on pages 46 to 56 you address specific risks related to your
intellectual property.
Intellectual Property, page 110
9.For each of your material licensed patents, please disclose (1) which patents or patent
applications are material to HMI-102; (2) expected expiration dates for patent
applications; and (3) the jurisdictions where patents are issued and patent applications are
pending. Please also explain what you mean that certain patents are "generally" expected
to expire in 2031 and 2034.
Collaboration and License Agreement with Novartis Institutes for BioMedical Research, Inc.,
page 112
10.We note that you are eligible to earn tiered royalties on net sales of licensed products by
Novartis ranging from mid single-digit to low double-digit percentages. This disclosure
is too broad and could imply that your royalty rate is up to 49%. Please revise your
disclosure here and throughout the prospectus to give investors a reasonable idea of the
amount of the royalty rate that does not exceed 10 percentage points
Consolidated Statements of Convertible Preferred Stock and Stockholders’ Deficit for the Year
Ended December 31, 2016, page F-5
11.Please explain the negative balance carried under Additional Paid-in Capital.
Notes to Consolidated Financial Statements
2. Summary of Significant Accounting Policies, page F-7
12.Please disclose your revenue recognition policy.
7. License Agreements
City of Hope, page F-13
13.Please disclose your obligations under the sponsored research agreement with COH.
FirstName LastNameArthur Tzianabos
Comapany NameHomology Medicines, Inc.
June 16, 2017 Page 4
FirstName LastName
Arthur Tzianabos
Homology Medicines, Inc.
January 19, 2018
Page 4
General
14.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.
15.Please provide us proofs of all graphics, visual, or photographic information you will
provide in the printed prospectus prior to its use, for example in a preliminary prospectus.
Please note that we may have comments regarding this material.
You may contact Keira Nakada at 202-551-3659 or Angela Connell at 202-551-3426 if
you have questions regarding comments on the financial statements and related matters. Please
contact Jeffrey Gabor at 202-551-2544 or Erin Jaskot at 202-551-3442 with any other questions.
Division of Corporation Finance
Office of Healthcare & Insurance
cc: Wesley Holmes