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Voyager Therapeutics, Inc.
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1 company response(s)
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Voyager Therapeutics, Inc.
Response Received
1 company response(s)
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Voyager Therapeutics, Inc.
Response Received
2 company response(s)
High - file number match
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Company responded
2019-11-22
Voyager Therapeutics, Inc.
References: November 19, 2019
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Voyager Therapeutics, Inc.
Response Received
2 company response(s)
Medium - date proximity
SEC wrote to company
2016-12-19
Voyager Therapeutics, Inc.
Filing - SEC Comment Letter to Voyager Therapeutics, Inc.
UPLOAD · 2016-12-19
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Company responded
2016-12-19
Voyager Therapeutics, Inc.
References: December 16, 2016
Filing - Correspondence from Voyager Therapeutics, Inc.
CORRESP · 2016-12-19
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Company responded
2016-12-20
Voyager Therapeutics, Inc.
Filing - Correspondence from Voyager Therapeutics, Inc.
CORRESP · 2016-12-20
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Voyager Therapeutics, Inc.
Response Received
4 company response(s)
Medium - date proximity
SEC wrote to company
2015-09-15
Voyager Therapeutics, Inc.
Filing - SEC Comment Letter to Voyager Therapeutics, Inc.
UPLOAD · 2015-09-15
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Company responded
2015-10-09
Voyager Therapeutics, Inc.
References: September 14, 2015
Filing - Correspondence from Voyager Therapeutics, Inc.
CORRESP · 2015-10-09
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Company responded
2015-10-16
Voyager Therapeutics, Inc.
Filing - Correspondence from Voyager Therapeutics, Inc.
CORRESP · 2015-10-16
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Company responded
2015-11-06
Voyager Therapeutics, Inc.
Filing - Correspondence from Voyager Therapeutics, Inc.
CORRESP · 2015-11-06
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Company responded
2015-11-06
Voyager Therapeutics, Inc.
Filing - Correspondence from Voyager Therapeutics, Inc.
CORRESP · 2015-11-06
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Voyager Therapeutics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2015-07-28
Voyager Therapeutics, Inc.
Filing - SEC Comment Letter to Voyager Therapeutics, Inc.
UPLOAD · 2015-07-28
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Voyager Therapeutics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2015-07-15
Voyager Therapeutics, Inc.
Filing - SEC Comment Letter to Voyager Therapeutics, Inc.
UPLOAD · 2015-07-15
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-11-26 | Company Response | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-11-10 | Company Response | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-11-09 | SEC Comment Letter | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-11-27 | Company Response | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-11-22 | Company Response | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-11-19 | SEC Comment Letter | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-12-20 | Company Response | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-12-19 | SEC Comment Letter | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-12-19 | Company Response | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-11-06 | Company Response | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-11-06 | Company Response | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-10-16 | Company Response | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-10-09 | Company Response | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-09-15 | SEC Comment Letter | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-07-28 | SEC Comment Letter | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-07-15 | SEC Comment Letter | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2022-11-09 | SEC Comment Letter | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-11-19 | SEC Comment Letter | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-12-19 | SEC Comment Letter | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-09-15 | SEC Comment Letter | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-07-28 | SEC Comment Letter | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-07-15 | SEC Comment Letter | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-11-26 | Company Response | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-11-10 | Company Response | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-11-27 | Company Response | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-11-22 | Company Response | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-12-20 | Company Response | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2016-12-19 | Company Response | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-11-06 | Company Response | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-11-06 | Company Response | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-10-16 | Company Response | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2015-10-09 | Company Response | Voyager Therapeutics, Inc. | DE | N/A | Read Filing View |
2025-11-26 - CORRESP - Voyager Therapeutics, Inc.
CORRESP 1 filename1.htm VOYAGER THERAPEUTICS, INC. 75 Hayden Avenue Lexington, MA 02421 November 26, 2025 VIA EDGAR SUBMISSION Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Voyager Therapeutics, Inc. Registration Statement on Form S-3 File No. 333-291418 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, Voyager Therapeutics, Inc. (the " Registrant ") hereby requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-291418), so that it may become effective at 4:30 p.m., Eastern time, on December 1, 2025, or as soon as practicable thereafter, or at such later time as the Registrant or its counsel may orally request via telephone call to the staff. Very truly yours, VOYAGER THERAPEUTICS, INC. By: /s/ Nathan Jorgensen Name: Nathan Jorgensen Title: Chief Financial Officer cc: Scott Townsend Senior Vice President of Legal and Chief Corporate Counsel Voyager Therapeutics, Inc. Robin Swartz Chief Business Officer and Chief Operating Officer Voyager Therapeutics, Inc. Brian A. Johnson C.S. Avery Reaves Wilmer Cutler Pickering Hale and Dorr LLP
2022-11-10 - CORRESP - Voyager Therapeutics, Inc.
CORRESP
1
filename1.htm
VOYAGER THERAPEUTICS, INC.
64 Sidney Street
Cambridge, MA 02139
November 10, 2022
VIA EDGAR SUBMISSION
Securities and Exchange Commission
Division of Corporation Finance
100 F Street, N.E.
Washington, D.C. 20549
Re: Voyager Therapeutics, Inc.
Registration Statement on Form S-3
File No. 333-268240
Request for Acceleration
Ladies and Gentlemen:
Pursuant to Rule 461 promulgated under the Securities Act of 1933,
as amended, Voyager Therapeutics, Inc. (the “Registrant”) hereby requests acceleration of the effective date of
its Registration Statement on Form S-3 (File No. 333-268240), so that it may become effective at 4:30 p.m., Eastern time,
on November 15, 2022, or as soon as practicable thereafter, or at such later time as the Registrant or its counsel may orally request
via telephone call to the staff.
Very truly yours,
VOYAGER THERAPEUTICS, INC.
By:
/s/ Peter P. Pfreundschuh
Name:
Peter P. Pfreundschuh
Title:
Chief Financial Officer
cc:
Robert W. Hesslein
Senior Vice President and General Counsel
Voyager Therapeutics, Inc.
Brian A. Johnson
C.S. Avery Reaves
Wilmer Cutler Pickering Hale
and Dorr LLP
2022-11-09 - UPLOAD - Voyager Therapeutics, Inc.
United States securities and exchange commission logo
November 9, 2022
Alfred Sandrock
President and Chief Executive Officer
Voyager Therapeutics, Inc.
64 Sidney Street
Cambridge, Massachusetts 02139
Re:Voyager Therapeutics, Inc.
Registration Statement on Form S-3
Filed November 8, 2022
File No. 333-268240
Dear Alfred Sandrock:
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 Joshua Gorsky at 202-551-7836 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Brian A. Johnson, Esq.
2019-11-27 - CORRESP - Voyager Therapeutics, Inc.
CORRESP 1 filename1.htm VOYAGER THERAPEUTICS, INC. 75 Sidney Street Cambridge, MA 02139 November 27, 2019 VIA EDGAR SUBMISSION Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Re: Voyager Therapeutics, Inc. Registration Statement on Form S-3 File No. 333-234527 Request for Acceleration Ladies and Gentlemen: Pursuant to Rule 461 promulgated under the Securities Act of 1933, as amended, Voyager Therapeutics, Inc. hereby requests acceleration of the effective date of its Registration Statement on Form S-3 (File No. 333-234527), so that it may become effective at 4:00 p.m., Eastern time, on December 2, 2019, or as soon as practicable thereafter. Very truly yours, VOYAGER THERAPEUTICS, INC. By: /s/ Robert W. Hesslein Name: Robert W. Hesslein Title: Senior Vice President & General Counsel
2019-11-22 - CORRESP - Voyager Therapeutics, Inc.
CORRESP 1 filename1.htm November 22, 2019 By Electronic Submission Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Paul Fischer Re: Voyager Therapeutics, Inc. Registration Statement on Form S-3 Filed November 6, 2019 File No. 333-234527 Ladies and Gentlemen: On behalf of Voyager Therapeutics, Inc. (the “Company”), we are responding to the comment of the staff (the “Staff”) of the Securities and Exchange Commission contained in its letter dated November 19, 2019, relating to the above referenced Registration Statement on Form S-3 filed on November 6, 2019 (the “S-3 Registration Statement”). Set forth below is the single Staff comment to the S-3 Registration Statement and the Company’s response to this comment. The response set forth below is based upon information provided to Wilmer Cutler Pickering Hale and Dorr LLP by the Company. Registration Statement on Form S-3, filed on November 6, 2019 Exclusive Forum Selection, page 25 1. We note that your exclusive forum selection identifies the Court of Chancery of the State of Delaware as the exclusive forum for certain litigation, including any “derivative action.” Please disclose whether this provision applies to actions arising under the Securities Act or the Exchange Act. In that regard, we note that Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder, and Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and regulations thereunder. If the provision applies to Securities Act claims, please revise your prospectus to state that there is uncertainty as to whether a court would enforce such provision and investors cannot waive compliance with the federal securities laws and the rules and regulations thereunder. If the provision does not apply to actions arising under the Securities Act or Exchange Act, please also tell us how you will inform investors in future filings that the provision does not apply to any actions arising under the Securities Act or Exchange Act. Company Response To inform investors regarding the effect of the applicability of the Company’s exclusive forum provisions, in the Company’s future quarterly and annual reports, including the Company’s Annual Report on Form 10-K for the year ended December 31, 2019, the Company will revise its existing risk factor disclosure on this topic as follows (with revisions emphasized below by italicized and underlined text): “Our amended and restated certificate of incorporation designates the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees. Our amended and restated certificate of incorporation provides that, unless we consent in writing to an alternative forum, the Court of Chancery of the State of Delaware will be the sole and exclusive forum for (i) any derivative action or proceeding brought on our behalf, (ii) any action asserting a claim of breach of a fiduciary duty owed by any of our directors, officers and employees to us or our stockholders, (iii) any action asserting a claim arising pursuant to any provision of the Delaware General Corporation Law, our certificate of incorporation or our bylaws or (iv) any action asserting a claim that is governed by the internal affairs doctrine, in each case subject to the Court of Chancery having personal jurisdiction over the indispensable parties named as defendants therein. Any person purchasing or otherwise acquiring any interest in any shares of our capital stock shall be deemed to have notice of and to have consented to this provision of our amended and restated certificate of incorporation. This choice of forum provision is inapplicable to actions arising under the Securities Exchange Act of 1934, as amended, and we likewise do not intend to apply this choice of forum provision to actions arising under the Securities Act of 1933, as amended. This choice of forum provision may limit a stockholder’s ability to bring a claim that is not arising under the Securities Exchange Act of 1934, as amended, or the Securities Act of 1933, as amended, in a judicial forum that he, she or it finds favorable for disputes with us or our directors, officers or employees, which may discourage such lawsuits against us and our directors, officers and employees even though an action, if successful, might benefit our stockholders. Stockholders who do bring a claim in the Court of Chancery could face additional litigation costs in pursuing any such claim, particularly if they do not reside in or near the State of Delaware. The Court of Chancery may also reach different judgments or results than would other courts, including courts where a stockholder considering an action may be located or would otherwise choose to bring the 2 action, and such judgments or results may be more favorable to us than to our stockholders. Alternatively, if a court were to find this provision of our amended and restated certificate of incorporation inapplicable to, or unenforceable in respect of, one or more of the specified types of actions or proceedings, we may incur additional costs and business interruption that could have a material adverse effect on our business, financial condition or results of operations.” If you have any further questions or comments, or if you require any additional information, please contact the undersigned by telephone at (212) 937-7206 or e-mail at brian.johnson@wilmerhale.com. Thank you for your assistance. Very truly yours, /s/ Brian A. Johnson Brian A. Johnson cc: Andre Turenne, Voyager Therapeutics, Inc. Robert W. Hesslein, Voyager Therapeutics, Inc. Allison Dorval, Voyager Therapeutics, Inc. 3
2019-11-19 - UPLOAD - Voyager Therapeutics, Inc.
November 19, 2019
Andre Turenne
Chief Executive Officer
Voyager Therapeutics, Inc.
75 Sidney Street
Cambridge, MA 02139
Re:Voyager Therapeutics, Inc.
Registration Statement on Form S-3
Filed on November 6, 2019
File No. 333-234527
Dear Mr. Turenne:
We have limited our review of your registration statement to those issues we have
addressed in our 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.
Registration Statement on Form S-3, filed on November 6, 2019
Exclusive Forum Selection, page 25
1.We note that your exclusive forum selection identifies the Court of Chancery of the State
of Delaware as the exclusive forum for certain litigation, including any "derivative
action." Please disclose whether this provision applies to actions arising under the
Securities Act or the Exchange Act. In that regard, we note that Section 27 of the
Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any
duty or liability created by the Exchange Act or the rules and regulations thereunder, and
Section 22 of the Securities Act creates concurrent jurisdiction for federal and state courts
over all suits brought to enforce any duty or liability created by the Securities Act or the
rules and regulations thereunder. If the provision applies to Securities Act claims, please
revise your prospectus to state that there is uncertainty as to whether a court would
enforce such provision and investors cannot waive compliance with the federal securities
FirstName LastNameAndre Turenne
Comapany NameVoyager Therapeutics, Inc.
November 19, 2019 Page 2
FirstName LastName
Andre Turenne
Voyager Therapeutics, Inc.
November 19, 2019
Page 2
laws and the rules and regulations thereunder. If the provision does not apply to actions
arising under the Securities Act or Exchange Act, please also tell us how you will inform
investors in future filings that the provision does not apply to any actions arising under the
Securities Act or Exchange Act.
We remind you that the company and its management are responsible for the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action or absence of
action by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Paul Fischer, Staff Attorney, at 202-551-3415, or Celeste M. Murphy,
Legal Branch Chief, at 202-551-3257, with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Brian Johnson, Esq.
2016-12-20 - CORRESP - Voyager Therapeutics, Inc.
CORRESP 1 filename1.htm VIA EDGAR AND FACSIMILE December 20, 2016 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Susan Hayes Re: Voyager Therapeutics, Inc. Acceleration Request for Registration Statement on Form S-3 File No. 333-214861 Dear Ms. Hayes, Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Voyager Therapeutics, Inc. (the “Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to December 20, 2016, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Goodwin Procter LLP by calling Edwin O’Connor at (212) 813 8853. We also respectfully request that a copy of the written order from the Securities and Exchange Commission (the “Commission”) verifying the effective time and date of the Registration Statement be sent to our counsel, Goodwin Procter LLP, Attention: Edwin O’Connor, by facsimile to (212) 937 3476. If you have any questions regarding this request, please contact Edwin O’Connor of Goodwin Procter LLP at (212) 813 8853. Sincerely, VOYAGER THERAPEUTICS, INC. /s/ Steven M. Paul Steven M. Paul, M.D. President and Chief Executive Officer cc: J. Jeffrey Goater, Voyager Therapeutics, Inc. Mitchell S. Bloom, Goodwin Procter LLP Edwin O’Connor, Goodwin Procter LLP Laurie A. Burlingame, Goodwin Procter LLP
2016-12-19 - UPLOAD - Voyager Therapeutics, Inc.
December 16, 2016
Steven M. Paul, M.D.
President and Chief Executive Officer
Voyager Therapeutics, Inc.
75 Sidney Street
Cambridge, MA 02139
Voyager Therapeutics, Inc.
Registration Statement on Form S-3
Filed December 1, 2016
File No. 333-214861Re:
Dear Dr. Paul, M.D.:
We have limited our review of your registration statement to those issues we have
addressed in our 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-3 filed December 1, 2016
Plan of Distribution, page 10
Your plan of distribution and coverpage for the sales agreement prospectus indicate that
sales of your common stock, if any, will be made at market prices by any method that is
deemed to be an "at the market offering" as defined in Rule 415 under the Securities Act,
including sales made directly on The NASDAQ Global Select Market or any other
trading market for your common stock, or sales to or through a market maker other than
on an exchange. Your disclosure also states that Cowen and Company may sell your
common stock by any other method permitted by law, including negotiated transactions.
Please tell us whether sales made to or through a market maker or sales made in
negotiated transactions satisfy the “at the market offering” definition under Rule 415. If
any sales method does not constitute a sales method that is deemed to be an “at the1.
Steven M. Paul, M.D.
Voyager Therapeutics, Inc.
2 PageDecember 16, 2016
market offering” as defined in Rule 415 or if any material information with respect to a
particular offering has been omitted, please confirm that you will file an additional
prospectus supplement at the time of such sales or tell us why such additional filing
would not be necessary.
Exhibits
Please file your indentures (Exhibits 4.2 and 4.3) prior to effectiveness of the registration
statement.2.
We remind you that the company and its management are responsible for the accuracy and
adequacy of their disclosures, notwithstanding any review, comments, action or absence of action
by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Joseph McCann at (202) 551-6262 or Suzanne Hayes, Assistant Director, at
(202) 551-3675 with any questions.
Division of Corporation Finance
Office of Healthcare & Insurance
2016-12-19 - CORRESP - Voyager Therapeutics, Inc.
CORRESP 1 filename1.htm December 19, 2016 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4561 100 F. Street, N.E. Washington, D.C. 20549 Attention: Suzanne Hayes Joseph McCann Re: Voyager Therapeutics, Inc. Registration Statement on Form S-3 Filed December 1, 2016 File No. 333-214861 Dear Ms. Hayes: This letter is being submitted on behalf of Voyager Therapeutics, Inc. (the “Company”) in response to the comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the Company’s Registration Statement on Form S-3, File No. 333-214861, filed December 1, 2016 (the “Registration Statement”), as set forth in your letter dated December 16, 2016 addressed to Dr. Steven M. Paul, President and Chief Executive Officer of the Company (the “Comment Letter”). The Company is concurrently filing with the Commission an amended Registration Statement, which includes changes that reflect responses to the Staff’s comments. For reference purposes, the text of the Comment Letter has been reproduced herein with responses below each numbered comment. Registration Statement on Form S-3 filed December 1, 2016 1. Your plan of distribution and coverpage for the sales agreement prospectus indicate that sales of your common stock, if any, will be made at market prices by any method that is deemed to be an “at the market offering” as defined in Rule 415 under the Securities Act, including sales made directly on The NASDAQ Global Select Market or any other trading market for your common stock, or sales to or through a market maker other than on an exchange. Your disclosure also states that Cowen and Company may sell your common stock by any other method permitted by law, including negotiated transactions. Please tell us whether sales made to or through a market maker or sales made in negotiated transactions satisfy the “at the market offering” definition under Rule 415. If any sales method does not constitute a sales method that is deemed to be an “at the market offering” as defined in Rule 415 or if any material information with respect to a particular offering has been omitted, please confirm that you will file an additional prospectus supplement at the time of such sales or tell us why such additional filing would not be necessary. RESPONSE: The Company acknowledges the Staff’s comment. The Company has revised its disclosure on the coverpage and page 10 of the sales agreement prospectus to provide that sales may be made only in an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act of 1933, as amended (the “Securities Act”). The Company hereby confirms that if any sales method does not constitute a sales method that is deemed to be an “at the market offering” as defined in Rule 415(a)(4) of the Securities Act, or if any material information with respect to a particular offering has been omitted, it will file an additional prospectus supplement at the time of such sales. Exhibits 2. Please file your indentures (Exhibits 4.2 and 4.3) prior to effectiveness of the registration statement. RESPONSE: The Company acknowledges the Staff’s comment and has filed the indentures as Exhibits 4.2 and 4.3 to the Registration Statement. Should you have any further comments or questions with regard to the foregoing, please do not hesitate to contact the undersigned by phone at (617) 570-1879, by facsimile transmission at (617) 321-4398 or by e-mail LBurlingame@goodwinlaw.com, or Edwin O’Connor by phone at (212) 813-8853, by facsimile transmission at (212) 937-3476 or by email at EOConnor@goodwinlaw.com.com. Sincerely, /s/ Laurie A. Burlingame, Esq. Goodwin Procter LLP cc: Dr. Steven M. Paul, Voyager Therapeutics, Inc. J. Jeffrey Goater, Voyager Therapeutics, Inc. Mitchell S. Bloom, Esq., Goodwin Procter LLP Edwin O’Connor, Esq., Goodwin Procter LLP
2015-11-06 - CORRESP - Voyager Therapeutics, Inc.
CORRESP 1 filename1.htm VIA EDGAR AND FACSIMILE November 6, 2015 United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4561 100 F Street, N.E. Washington, D.C. 20549 Attention: Jeffrey P. Riedler Re: Voyager Therapeutics, Inc. Acceleration Request for Registration Statement on Form S-1 File No. 333-207367 Dear Mr. Riedler, Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), Voyager Therapeutics, Inc. (the “Company”) hereby requests that the effective date of the above-referenced registration statement (the “Registration Statement”) be accelerated to November 10, 2015, at 4:00 p.m., Eastern Time, or as soon thereafter as practicable, unless we or our outside counsel, Goodwin Procter LLP, request by telephone that such Registration Statement be declared effective at some other time. In making this acceleration request, the Company acknowledges that it is aware of its responsibilities under the Act. Once the Registration Statement is effective, please orally confirm the event with our counsel, Goodwin Procter LLP by calling Laurie A. Burlingame at (617) 570-1879. We also respectfully request that a copy of the written order from the Securities and Exchange Commission (the “Commission”) verifying the effective time and date of the Registration Statement be sent to our counsel, Goodwin Procter LLP, Attention: Laurie A. Burlingame, by facsimile to (617) 523-1231. In connection with the foregoing, the Company hereby acknowledges the following: · should the Commission or the staff of the Commission, acting pursuant to delegated authority, declare the Registration Statement effective, it does not foreclose the Commission from taking any action with respect to the Registration Statement; · the action of the Commission or the staff of the Commission, acting pursuant to delegated authority, in declaring the Registration Statement effective, does not relieve the Company from its full responsibility for the adequacy and accuracy of the disclosure in the Registration Statement; and · the Company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. If you have any questions regarding this request, please contact Laurie A. Burlingame of Goodwin Procter LLP at (617) 570-1879. Sincerely, VOYAGER THERAPEUTICS, INC. /s/ Steven M. Paul Steven M. Paul, M.D. President and Chief Executive Officer cc: Jeff Goater, Voyager Therapeutics, Inc. Mitchell S. Bloom, Goodwin Procter LLP Edwin O’Connor, Goodwin Procter LLP Laurie A. Burlingame, Goodwin Procter LLP
2015-11-06 - CORRESP - Voyager Therapeutics, Inc.
CORRESP 1 filename1.htm VIA EDGAR November 6, 2015 United State Securities and Exchange Commission Division of Corporation Finance Mail Stop 4720 100 F Street, N.E. Washington, D.C. 20549 Attn: Jeffrey P. Riedler, Assistant Director Re: Voyager Therapeutics, Inc. (the “Company”) Registration Statement on Form S-1 File No. 333-207367 Ladies and Gentlemen: Pursuant to Rule 461 under the Securities Act of 1933, as amended (the “Act”), and as representatives of the several underwriters of the Company’s proposed public offering of shares of the Company’s common stock, par value $0.001 per share (the “Common Stock”), we hereby join the Company’s request for acceleration of the effective date of the above-referenced Registration Statement, as amended, requesting effectiveness for 4:00 p.m. (ET) on November 10, 2015, or as soon thereafter as practicable. Pursuant to Rule 460 of the Act, we wish to advise you that we have distributed approximately 755 copies of the Company’s preliminary prospectus relating to the Common Stock, dated October 30, 2015, through the date hereof to underwriters, dealers, institutions and others. The undersigned, as representatives of the several underwriters, have complied and will continue to comply, and have been informed by the participating underwriters that they have complied and will continue to comply, with the provisions of Rule 15c2-8 of the Securities Exchange Act of 1934, as amended. [Signature page follows] Very truly yours, COWEN AND COMPANY, LLC PIPER JAFFRAY & CO. Acting on their own behalf and as representatives of several underwriters By: COWEN AND COMPANY, LLC By: /s/ George Milstein Name: George Milstein Title: Co-head of Healthcare Investment Banking By: PIPER JAFFRAY & CO. By: /s/ Christie L. Christina Name: Christie L. Christina Title: Managing Director [Signature Page to Acceleration Request]
2015-10-16 - CORRESP - Voyager Therapeutics, Inc.
CORRESP 1 filename1.htm Goodwin Procter LLP Counselors at Law Exchange Place Boston, MA 02109 T: 617.570.1000 F: 617.523.1231 October 16, 2015 FOIA Confidential Treatment Request The entity requesting confidential treatment is: Voyager Therapeutics, Inc. 215 First Street Cambridge, MA 02142 CERTAIN PORTIONS OF THIS LETTER HAVE BEEN OMITTED FROM THE VERSION FILED VIA EDGAR. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. INFORMATION THAT WAS OMITTED IN THE EDGAR VERSION HAS BEEN NOTED IN THIS LETTER WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***].” THE OMITTED PORTIONS ARE BRACKETED IN THIS LETTER FOR EASE OF IDENTIFICATION. VIA EDGAR AND FEDERAL EXPRESS United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4561 100 F Street, N.E. Washington, D.C. 20549 Attention: Tara Keating Brooks RE: Voyager Therapeutics, Inc. Registration Statement on Form S-1 (the “Registration Statement”) File No. 333-207367 CIK No. 0001640266 Securities and Exchange Commission October 16, 2015 Page 2 Confidential Treatment Requested by Voyager Therapeutics, Inc. VYGR-0002 Dear Ms. Brooks: This letter is being submitted on behalf of Voyager Therapeutics, Inc. (the “Company”) to supplementally provide the Staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with additional information with respect to the above-referenced Registration Statement that was filed with the Commission on October 9, 2015. To assist the Staff of the Commission in the review of the Registration Statement, the Company advises the Staff that the managing underwriters of the initial public offering have communicated to the Company that they currently expect the proposed price range for the common stock to be between $[***] to $[***] per share, after giving effect to a [***] for 1 reverse stock split to be implemented prior to the consummation of the initial public offering. The anticipated price range for this offering is based on a number of factors, including the prevailing market conditions and estimates of the Company’s business potential, the general condition of the securities market, the recent market prices of, and the demand for, publicly traded common stock of generally comparable companies and preliminary discussions with the underwriters for this offering regarding potential valuations of the Company. The actual bona fide price range to be included in a subsequent amendment to the Registration Statement has not yet been determined and remains subject to adjustment based on factors outside of the Company’s control. However, the Company believes that the actual bona fide price range will be within this estimated price range, but could be lower than this estimated price range. We confirm on behalf of the Company that, prior to circulating copies of the preliminary prospectus in connection with this offering, the Company will file a pre-effective amendment to the Registration Statement that will include all information other than information that may be excluded in reliance upon Rule 430A of Regulation C, and the actual price range to be included in such amendment which will comply with the Staff’s interpretation regarding the parameters of a bona fide price range. Estimated Initial Public Offering Price The estimated price range for this offering was determined with reference to several quantitative and qualitative factors. In mid-October 2015, the Company and the underwriters determined the estimated price range for this offering to be $[***] to $[***] per share. In comparison, the Company’s Board of Directors (the “Board of Directors”) estimated the fair value of the Company’s common stock was [***] per share as of October 6, 2015, after giving effect to a [***] to 1 reverse split, based in part upon a third-party valuation of the Company’s common stock as of September 30, 2015. Securities and Exchange Commission October 16, 2015 Page 3 Confidential Treatment Requested by Voyager Therapeutics, Inc. VYGR-0003 In October 2015, the Company obtained a third-party valuation of its common stock as of September 30, 2015, which was considered by the Board of Directors in its determination of the fair value of its common stock for stock options granted on October 6, 2015. The valuation analysis was prepared using a hybrid method which probability weighted the initial public offering (“IPO”) and option pricing method (“OPM”) scenarios. For those two future-event scenarios, management and the Board of Directors determined that the probability of either scenario was 50%. In determining the enterprise value for the OPM scenario, the Company (1) estimated the time to liquidity as 2.37 years; (2) assumed volatility of 75%, based on historical trading volatility for its publicly traded peer companies; and (3) used a risk-free rate of return of 0.8%, based on a pro-rated U.S. Treasury yield curve. In determining the enterprise value, the Company applied the guideline public company method under the market approach, which considered the multiple of paid-in-capital balance for a group of comparable biopharmaceutical companies that had recently completed IPOs. The comparable companies were selected based on a number of factors, including the similarity of their industry, business model, financial risk and stage of development to the Company. For the IPO scenario, the Company estimated time to completion of the IPO as 3.0 months and applied a risk-adjusted discount rate of 30% to the common stock and 25% to the preferred stock, based on three studies that indicated rates of return required by venture investors for bridge financing or IPO-stage companies. The Company then applied a discount for lack of marketability of 27% under the OPM scenario and 8% under the IPO scenario. The Company notes that, as is typical in initial public offerings, the price range for this offering was not derived using a formal determination of fair value, but was determined based upon discussions between the Company and the underwriters. Among the factors considered in setting the price range for this offering were the following: · an analysis of the typical valuation ranges seen in recent IPOs for companies in the same industry as the Company; · the general condition of the securities market and the recent market prices of, and the demand for, publicly traded common stock of generally comparable companies to the Company; · an assumption that there would be a receptive public trading market for biopharmaceutical companies such as the Company; and · an assumption that there would be sufficient demand for the Company’s common stock to support an offering of the size contemplated by the prospectus included in the Registration Statement. Securities and Exchange Commission October 16, 2015 Page 4 Confidential Treatment Requested by Voyager Therapeutics, Inc. VYGR-0004 In addition, the Company believes that the difference in value reflected between the midpoint of the estimated price range for this offering and the Board of Directors’ determination of the fair value of the Company’s common stock on October 6, 2015 was primarily the result of the following circumstances and events occurring subsequent to October 6, 2015: · The following significant events occurred in the Company’s lead program from advanced Parkinson’s disease, or VY-AADC01: (1) the investigational new drug application (the “IND”) for VY-AADC01 was formally transferred to the Company from the University of California, San Francisco, such that the Company is now the sponsor of the ongoing Phase 1b clinical trial. Since the Company is now the holder of the IND, it has greater control over the conduct of this trial; (2) the Company received interim three month data from the first patient treated with VY-AADC01 under the amended protocol for the ongoing Phase 1b clinical trial, which provides for the administration of a larger volume of VY-AADC01 to the putamen to increase the area of the putamen covered by VY-AADC01, that demonstrated encouraging signs of efficacy and safety and suggests that efficacy signs may be seen as a result of increased coverage of the putamen; and (3) the surgical procedure for the latest patient treated in the ongoing Phase 1b clinical trial, the first to be treated with a lower limb sequential compression device during the surgical procedure, was successful (i.e., no serious adverse events were seen and threshold coverage of target region of the brain was achieved), thereby providing support for a recent protocol amendment to further optimize the surgical approach. · The IPO price is based only upon a scenario in which the Company completes this offering and is not probability weighted, in contrast to the Company’s prior valuations of common stock, which considered two potential outcomes, one of which would have resulted in a lower value of the Company’s common stock than an IPO. Under the IPO scenario of the valuation analysis completed as of September 30, 2015, the undiscounted non-probability-weighted pre-money IPO valuation was determined to be approximately $[***] or $[***] per share, after giving effect to a [***] to 1 reverse split. By comparison, the implied pre-money valuation at the mid-point of the valuation range provided by the underwriters is approximately $[***]; this represents an approximately [***]% increase Securities and Exchange Commission October 16, 2015 Page 5 Confidential Treatment Requested by Voyager Therapeutics, Inc. VYGR-0005 relative to the amount used in the IPO scenario in the valuation as of September 30, 2015. Given the significant milestones achieved in the Company’s lead program after October 6, 2015, the Company believes that the [***]% increase is reasonable. The probability weighting of the two scenarios was based, in part, on the fact that interim three month data from the first patient dosed under the revised protocol was not available and that the latest patient had not yet been treated as of September 30, 2015, which were two events that influenced the decision to continue to pursue an IPO. · The IPO price necessarily assumes that the IPO has occurred and that a public market for the Company’s common stock has been created, and, therefore, it excludes any discount for lack of marketability of the Company’s common stock, which was taken into account in the Board of Directors’ determination of the fair value of the Company’s common stock on October 6, 2015. In the September 30, 2015 third-party valuation, the discount for lack of marketability that was applied to the IPO and OPM scenarios was 8% and 27%, respectively. · The Company’s convertible preferred stock has substantial economic rights and preferences superior to the Company’s common stock. The IPO price assumes the conversion of the Company’s convertible preferred stock to common stock upon the completion of this offering and the corresponding elimination of such superior economic rights and preferences. · Furthermore, the actual IPO price could be lower than estimated price range and pre-IPO shares of common stock are expected to be subject to a 180 day lock-up. The Company respectfully requests that the Staff return to us this letter pursuant to Rule 418 of the Securities Act of 1933, as amended, once the Staff has completed its review. We have provided a self-addressed stamped envelope for this purpose. In addition, the Company requests confidential treatment under 17 C.F.R. § 200.83 (1992) for this letter and has submitted a separate request for confidential treatment in accordance therewith to the Commission’s Office of Freedom of Information and Privacy Act Operations. *-*-*-* If you have any questions or comments regarding the foregoing, or if there is any additional information that we might provide to assist the Staff’s review, please contact the undersigned at (617) 570-1879. Sincerely, /s/ Laurie A. Burlingame Laurie A. Burlingame cc: Mitchell S. Bloom, Goodwin Procter LLP Edwin M. O’Connor, Goodwin Procter LLP Steven Paul, Voyager Therapeutics, Inc. J. Jeffrey Goater, Voyager Therapeutics, Inc.
2015-10-09 - CORRESP - Voyager Therapeutics, Inc.
CORRESP 1 filename1.htm Goodwin Procter LLP Counselors at Law Exchange Place Boston, MA 02109 T: 617.570.1000 F: 617.523.1231 October 9, 2015 VIA EDGAR AND FEDERAL EXPRESS United States Securities and Exchange Commission Division of Corporation Finance Mail Stop 4561 100 F. Street, N.E. Washington, D.C. 20549 Attention: Suzanne Hayes Re: Voyager Therapeutics, Inc. Amendment No. 3 to Confidential Draft Registration Statement on Form S-1 Submitted August 28, 2015 CIK No. 0001640266 Dear Ms. Hayes: This letter is submitted on behalf of Voyager Therapeutics, Inc. (the “Company”) in response to the comments of the staff of the Division of Corporation Finance (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) with respect to the Company’s Amendment No. 3 to Draft Registration Statement on Form S-1, confidentially submitted on August 28, 2015 (the “Draft Registration Statement”), as set forth in the Staff’s letter dated September 14, 2015 addressed to Steven M. Paul, M.D., President and Chief Executive Officer of the Company (the “Comment Letter”). The Company is concurrently publicly filing the Registration Statement on Form S-1 (“Registration Statement”), which includes changes to the Draft Registration Statement in response to the Staff’s comments. For reference purposes, the text of the Comment Letter has been reproduced herein with responses below each numbered comment. For your convenience, we have italicized the reproduced Staff comments from the Comment Letter. Unless otherwise indicated, page references in the descriptions of the Staff’s comments refer to the Draft Registration Statement, and page references in the responses refer to the Registration Statement. All capitalized terms used and not otherwise defined herein shall have the meanings set forth in the Registration Statement. The responses provided herein are based upon information provided to Goodwin Procter LLP by the Company. In addition to confidentially submitting this letter via EDGAR, we are sending via Federal Express five (5) copies of each of this letter and the Registration Statement (marked to show changes from the Draft Registration Statement). 1. We refer to your disclosure regarding your “exclusive, worldwide, royalty-bearing license” agreement with the University of Massachusetts and the corresponding agreement filed as Exhibit 10.4. We also note your disclosure, “[w]e have exclusively licensed three families of patents and patent applications and nonexclusively licensed three families of patents and patent applications directed to RNAi constructs as vector payloads, their design and use in the treatment of CNS disorders from the University of Massachusetts,” in the second paragraph of “Licensed Intellectual Property” on page 122. Please expand your disclosure to indicate which patents and patent applications licensed from the University of Massachusetts are exclusive and which are non-exclusive. Please also discuss the material terms of any agreement with the University of Massachusetts relating to the non-exclusive licensed patent families. In addition, please file the agreement as an exhibit in accordance with Item 601 of Regulation S-K. RESPONSE: The Draft Registration Statement has been revised in response to the Staff’s comment. Please see revisions on page 123 of the Registration Statement. 2. We refer to your last patent disclosure on page 122. Please expand your disclosure to briefly identify the intellectual property and type of patent protection sought (e.g. method of use or composition of matter) to protect your intellectual property rights arising from the Amyotrophic Lateral Sclerosis Association grant. RESPONSE: The Draft Registration Statement has been revised in response to the Staff’s comment. Please see revisions on page 123 of the Registration Statement. If you should have any questions concerning the enclosed matters, please contact the undersigned at (617) 570-1055. Sincerely, /s/ Mitchell S. Bloom Mitchell S. Bloom cc: Steven M. Paul, M.D., President and Chief Executive Officer, Voyager Therapeutics, Inc. J. Jeffrey Goater, Senior Vice President, Finance & Business Development, Voyager Therapeutics, Inc. Edwin M. O’Connor, Esq., Goodwin Procter LLP Laurie A. Burlingame, Esq., Goodwin Procter LLP 2
2015-09-15 - UPLOAD - Voyager Therapeutics, Inc.
Mail Stop 4720 September 14, 2015 Steven M. Paul, M.D. President and Chief Executive Officer Voyager Therapeutics, Inc. 75 Sidney Street Cambridge, Massachusetts 02139 Re: Voyager Therapeutics, Inc. Amendment No. 3 to Draft Registration Statement on Form S -1 Submitted August 28 , 2015 CIK No. 0001640266 Dear Dr. Paul: We have reviewed your amended draft registration statement and have the following comments. In some of our comments, we may ask you to provide us with information so we may better understand your disclosure. Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement on EDGAR. If you do not believe our comments apply to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response. After reviewing the information you provide in re sponse to these comments and your amended draft registration statement or filed registration statement, we may have additional comments. License Agreement with University of Massachusetts, page 117 1. We refer to your disclosure regarding your “exclusive, worldwide, royalty -bearing license” agreement with the University of Massachusetts and the corresponding agreement filed as Exhibit 10.4. We also note your disclosure, “[w]e have exclusively licensed three families of patents and patent applications and nonexclusively licensed three families of patents and patent applications directed to RNAi constructs as vector payloads, their design and use in the treatment of CNS disorders from the University of Massachusetts,” in the second paragraph of “Licensed Int ellectual Property” on page 122. Please expand your disclosure to indicate which patents and patent applications licensed from the University of Massachusetts are exclusive and which are non -exclusive. Please Steven M. Paul, M.D. Voyager Therapeutics, Inc. September 14, 2015 Page 2 also discuss the material terms of any agreeme nt with the University of Massachusetts relating to the non -exclusive licensed patent families. In addition, please file the agreement as an exhibit in accordance with Item 601 of Regulation S -K. Company -Owned Intellectual Property, page 121 2. We refer to your last patent disclosure on page 122. Please expand your disclosure to briefly identify the intellectual property and type of patent protection sought (e.g. method of use or composition of matter) to protect your intellectual property rights arising f rom the The Amyotrophic Lateral Sclerosis Association grant. You may contact Keira Nakada at (202) 551 -3659 or James Rosenberg at 202 -551- 3679 if you have questions regarding comments on the financial statements and related matters. Please contact Tara Keating Brooks at (202) 551 -8336, Bryan Pitko at (202) 551 -3203 or me at (202) 551 -3675 with any other questions. Sincerely, /s/ Bryan J. Pitko for Suzanne Hayes Assistant Director cc: Via E -mail Mitchell S. Bloom, Esq. Goodwin Procter LLP
2015-07-28 - UPLOAD - Voyager Therapeutics, Inc.
July 28, 2015
Steven M. Paul, M.D.
President and Chief Executive Officer
Voyager Therapeutics, Inc.
75 Sidney Street
Cambridge, Massachusetts 02139
Re: Voyager Therapeutics, Inc.
Amendment No. 2 to Draft Registration Statement
Submitted July 21, 2015
CIK No. 0001640266
Dear Dr. Paul :
We have reviewed your amended draft registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
Please re spond 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 additio nal
comments.
The Voyager Product Engine, page 2
1. We refer to your response to prior comment 1. We also note your disclosure in the third
paragraph, “…. a baculovirus AAV production system, a system for manufacturing AAV
vectors that uses viruses from the baculoviridae family, which we use and have continued
to improve upon. ” Please revise this disclosure to explain in layman’s terms the meaning
or significance of the baculoviridae family to facilitate an understanding on the
baculovirus AAV produ ction system .
Manufacturing at Commercial Quality and Scale, page 5
2. We note your amended disclosure in response to our prior comment 6. Please clarify
your disclosure to identify where in the Western world Glybera is an approved AAV gene
therapy. In the alternative, please state that the FDA has not approved a gene therapy.
Steven M. Paul, M.D.
Voyager Therapeutics, Inc.
July 28, 2015
Page 2
Risk Factors, page 6
3. We refer to our prior comment 7 and your revised disclosure on page 6. We note yo ur
product candidates and the process for administering your product candid ates may cause
undesirable side effects. We also note your disclosure regarding several significant side
effects caused by other gene therapy treatments using non -AAV vectors. As disclosed in
your prospectus, patients in the prior Phase 1 trial utilizing AAV vectors experienced
hemorrhages relating to the surgical procedure of administering the treatment. Please
expand your bulleted risk factor to include other several significant side effects (i.e.
hemorrhages) associated with the administration of gene therapy products.
The dosing and delivery techniques being employed in the ongoing VY -AADC01, page 17
4. We refer to our prior comment 10 and your amended disclosure on pages 17, 95 and 102.
Please expand your disclosure to clearly state the previous p roblem(s) the system is
intended to solve. For example, if the Clearpoint System is being used to reduce the risk
of hemorrhages please revise your prospectus accordingly. In that regard, we note your
disclosure in the second to last paragraph on page 10 1, “[n] evertheless, the stereotactic
injection protocol used in the surgical procedure was modified to avoid specific blood
vessels and no further hemorrhages were reported. The implementation of real -time MRI
guidance in the ongoing Phase 1b clinical tria l is a significant advancement in vector
delivery. ”
Genzyme Collaboration Agreement, page F -20
5. We have read your revised disclosure in response to our prior comment 24. You disclose
in MD&A under research and development expense on page 82 that approxim ately $1
million was incurred on your behalf by third parties related to the Genzyme
Collaboration. Please tell us why you are unable to disclose this amount and other
expenses incurred or at least a reasonable estimate of expenses incurred under the
Genz yme Collaboration. Refer to ASC 730 -20-50-1b.
Steven M. Paul, M.D.
Voyager Therapeutics, Inc.
July 28, 2015
Page 3
You may contact Keira Nakada at (202) 551 -3659 or James Rosenberg at 202 -551-3679
if you have questions regarding comments on the financial statements and related matters. Please
contact Tara Keating Br ooks at (202) 551 -8336 or me at (202) 551 -3715 with any other
questions.
Sincerely,
/s/ Jeffrey P. Riedler
Jeffrey P. Riedler
Assistant Director
cc: Via E -mail
Mitchell S. Bloom, Esq .
Goodwin Procter LLP
2015-07-15 - UPLOAD - Voyager Therapeutics, Inc.
July 15, 2015
Via E-mail
Steven M. Paul, M.D.
President and Chief Executive Officer
Voyager Therapeutics, Inc.
75 Sidney Street
Cambridge, Massachusetts 02139
Re: Voyager Therapeutics, Inc.
Draft Registration Statement on Form S -1
Submitted June 19, 2015
CIK No. 0001640266
Dear Dr. Paul :
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 in formation 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 n ot 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 registrati on statement or filed registration statement, we may have additional
comments.
Prospectus Summary
1. Please clarify the meaning of any significant scientific or technical terms the first time
they are used in your prospectus in order to ensure that lay readers will understand the
disclosure. For example, please define each of the following at their first use:
clinically meaningful
adeno -associated virus
AAV vectors
oncogenesis
modalities
Steven M. Paul, M.D.
Voyager Therapeutics, Inc.
July 15, 2015
Page 2
baculovirus AAV
refractory to levodopa
monogenic amytotrophic later al sclerosis
2. We refer to your disclosure in the third paragraph on page 1 , that “AAV is able to transfer
a therapeutic gene, or transgene, into target cells in the CNS and is believed to be safe .”
We note your first full risk factor on page 20, “[t] here have been several significant side
effects caused by gene therapy treatments in the past, including reported cases of
leukemia and death. ” We also note, “[i] n previous Phase 1 clinical trials conducted by
others, several patients experienced hemorrhages f ollowing the surgical procedures ”
following the administration of the proposed therapy. In view of your disclosures
relating to severe adverse effects in other clinical trials and gene therapy, please expand
your disclosure in your prospectus summary to e xplain to potential investors why you
believe AAV is “believed to be safe.”
3. Please revise your disclosure to include a general description of the administration of
your AAV gene therapy in patients. For example, please disclose how the therapy is
deliver ed, whether the therapy is injected into patients, if surgery is required and the
intended injection or surgical sites in patients.
4. We refer to your disclosure in the third paragraph on page 1, “ CNS diseases are a leading
driver of global disease burden and represent the single largest biopharmaceutical market
with estimated worldwide annual sales of over $125 billion in 2013. ” Please revise your
estimated amount of worldwide annual sales to quantify the individual amounts relative
to your five in dications currently under development. Please make any corresponding
changes throughout your prospectus.
Preclinical Programs, page 4
5. We refer to your first bullet point regarding Monogenic ALS Program: VY -SOD101 . We
note your approximation of 30,000 patients in the United States with ALS, the percentage
of familial ALS patients , and the subset of patients with familial ALS cause d by
mutations in the SOD1 gene. The disclosed patient numbers and percentages suggest that
your actual potential patient po pulation for VY-SOD101 is 600 patients . If so, please
disclose your actual potential population for VY-SOD101 for patients with ALS caused
by mutations in the SOD1 gene .
Manufacturing at Commercial Quality and Scale, page 5
6. We refer to your fourth bull et point regarding an established regulatory framework for
the baculovirus AAV production system. We also note your disclosure that no gene
therapy has been approved by the FDA and only one therapy was approved by the
European Union. In addition, we also note your first risk factor on page 30 that to date
Steven M. Paul, M.D.
Voyager Therapeutics, Inc.
July 15, 2015
Page 3
no cGMP gene therapy manufacturing facility has received FDA approved. Please
revise your disclosure to further explain to investors how your AAV gene therapy
manufactured with the baculovirus system has the attribute of manufacturing under an
established regulatory framework.
Risk Factors, page 6
7. Please expand your fifth bulleted risk factor to include a brief discussion of the severe
adverse effects that have been associated with gene therapy.
Risk Factors, page 12
8. We refer to your disclosure in the third full paragraph on page 151 under Anti -Takeover
Provisions. Please add a risk factor describing the disadvantages to stockholders
attendant to the exclusive forum provision contained in your a mended and restated
certificate of incorporation.
9. We refer to your risk factor on page 17 and the subsequent risk factor on page 19 . We
note that these risk factors appear to be substantially similar and repetitive. Please revise
these risk factors to provide one concise risk factor to discuss the risks described therein.
10. We refer to your risk factor on page 17 and your use of the Clearpoint System in your
Phase1b clinical trial. Please expand your risk factor to briefly disclose why the
Clearpoint System is being utilized , the previous problem (s) the system is intended to
solve , and how the system works differently from earlier methods used in previous
clinical trials. In addition, please briefly describe the “Clearpoint System” in your
business se ction.
Use of Proceeds, page 61
11. Please revise your disclosure to quantify the amount of cash, including current available
cash, you anticipate after the completion of the offering and how you intend to apply the
entire amount of cash.
12. Please revise your disclosure to provide your best reasonable estimate of how the
proceeds from this offering and available cash will enable you to advance your identified
use of proceeds :
the VY-AADC01 program fo r advanced Parkinson’s disease , including relevant
clinical and manufacturing expenses; and
the advancement of your four preclinical pipeline products (i.e. VY -SOD101,
VY-FXN01, VY-HTT01 and VY -SMN101 ) and in each case preclinical
development, drug manufacturing, clinical development and internal personnel
costs .
Steven M. Paul, M.D.
Voyager Therapeutics, Inc.
July 15, 2015
Page 4
Determination of Fair Value of Common Stock on Grant Dates, page 77
13. We may have additional comments on your accounting for equity issuances including
stock based compensation and convertible instruments. Once you have an estimated
offering price, please provide us an analysis explaining the reasons for the differences
between the recent valuations of your common stock leading up to the IPO an d the
estimated offering price.
Vector Engineering and Optimization, page 92
14. We note your disclosure on the top of page 93 stating that FXN expression “was
normalized as a fold increase relative to FXN expression” in a human brain reference
sample. As this is not a term that is familiar to non -specialists, please briefly describe the
mean ing and significance of “normalized as a fold increase relative to FXN expression.”
Phase 1 Clinical Trials, page 99
15. Please expand your disclosure to briefly describe the primary endpoint for each of the
Phase 1 clinical trials and whether each endpoint was achieved .
16. We note your chart on the top on page 100. Please expand your disclosure to provide,
through a legend or other explanatory narrative:
what each figure represent s and what each number measured ; and
the control used and what the p-value measur ed.
In addition, please discuss the reliability of the p -values in view of the small number of
subjects in the study .
Our Program Status, page 101
17. Please revise your disclosure to include the primary endpoints of your Phase 1b clinical
trials. In tha t regard, we note your disclosure on the top of page 102 , “clinical readouts
will include standard endpoints, such as UPDRS…” P lease briefly explain how the
UPDRS is anticipated to be used in the analysis of trial results and how it will be
considered in regard to all endpoint measurements.
Collaborations and License Agreements , page 111
18. We refer to your announcement of the entry into a license agreement with REGENX
Biosciences, LLC. Please revise your prospectus to describe the material terms of the
agreement including:
the nature and scope of the intellectual property rights transferred and whether
such rights are exclusive;
each parties’ rights and obligations;
Steven M. Paul, M.D.
Voyager Therapeutics, Inc.
July 15, 2015
Page 5
duration and termination provisions;
material payment provisions, which may include up-front or execution payments;
milestones, royalty rates or revenue sharing; and
aggregate amounts paid or received to date.
In addition, please file the agreement as an exhibit in accordance with Item 601 of
Regulation S -K. In the alternative, please advise us as to why the agreement is not
material and the exhibit need not be filed.
License Agreement with the University of Massachusetts, page 113
19. Please revise your disclosure to provide a royalty range for your tiered minimum annual
royalty payments and a percentage range relating to the sublicensing income.
MassBiologics and UMass Collaboration Agreement, page 113
20. Please revise your disclosure to discuss the material terms of the agreement including:
nature and scope of each party’s intellectual property rights in the manufacturing
of recombinant AAV products ;
each parties’ material rights and obligations; and
duration and termination provisions
In addition, please file the agreement as an exhibit to your Form S -1 in accordance with
Item 601 of Regulation S -K.
Executive Officers and Directors, page 128
21. We refer to the signature page of A mendment 1 to your draft registration statement
submitted on June 29, 2015. We also note the reference to Perry Karsen as a director of
the company. Please update your disclosure here and throughout your Form S -1 to
include the disclosure s required for Mr. Karsen .
Summary Compensation Table, page 136
22. We note your inclusion of $50,000 to Dr. Pietrusko in the bonus column of your
summary compensation table. Please revise your table to include Dr. Pietrusko’s
relocation expenses in the “all other compensation” column in accordance with Item 402
of Regulation S -K.
Genzyme Collaboration Agreement , page F -20
23. Please disclose, separately, the amount of specified regulatory milestones in total and
commercial milestones in total, and the nature of the milestones within these two
categories. Refer to 605 -28-50.
Steven M. Paul, M.D.
Voyager Therapeutics, Inc.
July 15, 2015
Page 6
24. Please disclose the nature and amount of costs incurred under the agreement and where
they are classifie d within your statement of operations for the three months ended March
31, 2015, and thereafter for each period presented.
Other Agreements, page F -24
25. Please disclose the aggregate potential milestone payments under these agreements here in
and in your contractual obligations table.
Other Comments
26. Please submit all exhibits as soon as practicable. We may have further comments upon
examination of these exhibits.
27. Please confirm that the graphics included in your registration statement are the only
graphics you will use in your prospectus. If those are not the only graphics, please
provide any additional graphics prior to their use for our review.
28. Please suppleme ntally 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 Keira Nakada at (202) 551 -3659 or James Rosenberg at 202 -551-3679
if you have questions regarding comments on the financial statements and related matters. Please
contact Tara Keating Bro oks at (202) 551 -8336 or me at (202) 551 -3715 with any other
questions.
Sincerely,
/s/ Jeffrey P. Riedler
Jeffrey P. Riedler
Assistant Director
cc: Via E -mail
Mitchell S. Bloom, Esq .
Goodwin Procter LLP
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