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Stoke Therapeutics, Inc.
Response Received
1 company response(s)
Medium - date proximity
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Stoke Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2024-06-17
Stoke Therapeutics, Inc.
Summary
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Company responded
2024-06-17
Stoke Therapeutics, Inc.
Summary
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Stoke Therapeutics, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2023-11-16
Stoke Therapeutics, Inc.
Summary
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Company responded
2023-11-17
Stoke Therapeutics, Inc.
References: November 16, 2023
Summary
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Stoke Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-05-25
Stoke Therapeutics, Inc.
Summary
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Company responded
2022-05-26
Stoke Therapeutics, Inc.
Summary
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Stoke Therapeutics, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2020-07-15
Stoke Therapeutics, Inc.
Summary
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Company responded
2020-07-16
Stoke Therapeutics, Inc.
Summary
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Stoke Therapeutics, Inc.
Response Received
5 company response(s)
High - file number match
SEC wrote to company
2019-06-03
Stoke Therapeutics, Inc.
References: April 17, 2019
Summary
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Company responded
2019-06-03
Stoke Therapeutics, Inc.
Summary
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Company responded
2019-06-07
Stoke Therapeutics, Inc.
References: April 17, 2019 | June 3, 2019
Summary
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Company responded
2019-06-12
Stoke Therapeutics, Inc.
References: June 11, 2019
Summary
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Company responded
2019-06-14
Stoke Therapeutics, Inc.
Summary
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Company responded
2019-06-14
Stoke Therapeutics, Inc.
Summary
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Stoke Therapeutics, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-06-11
Stoke Therapeutics, Inc.
Summary
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Stoke Therapeutics, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2019-05-14
Stoke Therapeutics, Inc.
Summary
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Company responded
2019-05-23
Stoke Therapeutics, Inc.
References: May 14, 2019
Summary
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Stoke Therapeutics, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2019-04-17
Stoke Therapeutics, Inc.
Summary
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Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-07-09 | Company Response | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2025-06-30 | SEC Comment Letter | Stoke Therapeutics, Inc. | DE | 377-08144 | Read Filing View |
| 2024-06-17 | Company Response | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-06-17 | SEC Comment Letter | Stoke Therapeutics, Inc. | DE | 333-280172 | Read Filing View |
| 2023-11-17 | Company Response | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-11-16 | SEC Comment Letter | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-05-26 | Company Response | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-05-25 | SEC Comment Letter | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-07-16 | Company Response | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-07-15 | SEC Comment Letter | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-06-14 | Company Response | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-06-14 | Company Response | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-06-12 | Company Response | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-06-11 | SEC Comment Letter | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-06-07 | Company Response | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-06-03 | SEC Comment Letter | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-06-03 | Company Response | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-05-23 | Company Response | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-05-14 | SEC Comment Letter | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-04-17 | SEC Comment Letter | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-06-30 | SEC Comment Letter | Stoke Therapeutics, Inc. | DE | 377-08144 | Read Filing View |
| 2024-06-17 | SEC Comment Letter | Stoke Therapeutics, Inc. | DE | 333-280172 | Read Filing View |
| 2023-11-16 | SEC Comment Letter | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-05-25 | SEC Comment Letter | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-07-15 | SEC Comment Letter | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-06-11 | SEC Comment Letter | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-06-03 | SEC Comment Letter | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-05-14 | SEC Comment Letter | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-04-17 | SEC Comment Letter | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2025-07-09 | Company Response | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2024-06-17 | Company Response | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2023-11-17 | Company Response | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2022-05-26 | Company Response | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2020-07-16 | Company Response | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-06-14 | Company Response | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-06-14 | Company Response | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-06-12 | Company Response | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-06-07 | Company Response | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-06-03 | Company Response | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
| 2019-05-23 | Company Response | Stoke Therapeutics, Inc. | DE | N/A | Read Filing View |
2025-07-09 - CORRESP - Stoke Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP STOKE THERAPEUTICS, INC. 45 Wiggins Avenue Bedford, MA 01730 July 9, 2025 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Office of Life Sciences Re: Stoke Therapeutics, Inc. Registration Statement on Form S-3 Filed July 9, 2025 File No. 333-288583 Via EDGAR - Acceleration Request Requested Date: July 11, 2025 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: Stoke Therapeutics, Inc. (the “ Registrant ”) hereby requests that the Securities and Exchange Commission (the “ Commission ”) take appropriate action to make the above-captioned Registration Statement on Form S-3 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable. The Registrant hereby authorizes Robert A. Freedman or Julia Forbess, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration. The Registrant requests that it be notified of such effectiveness by a telephone call to Ms. Forbess at (415) 875-2420 or, in her absence, to Mr. Freedman at (206) 389-4524. * * * Sincerely, S TOKE T HERAPEUTICS , I NC . By: /s/ Thomas Leggett Thomas Leggett Chief Financial Officer cc: Ian F. Smith, Interim Chief Executive Officer Jonathan Allan, General Counsel Stoke Therapeutics, Inc. Robert A. Freedman, Esq. Julia Forbess, Esq. Fenwick & West LLP
2025-06-30 - UPLOAD - Stoke Therapeutics, Inc. File: 377-08144
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> June 30, 2025 Ian F. Smith Interim Chief Executive Officer Stoke Therapeutics, Inc. 45 Wiggins Avenue Bedford, MA 01730 Re: Stoke Therapeutics, Inc. Draft Registration Statement on Form S-3 Submitted June 26, 2025 CIK No. 0001623526 Dear Ian F. Smith: This is to advise you that we do not intend to review your registration statement. We request that you publicly file your registration statement at least two business days prior to the requested effective date and time. Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Tim Buchmiller at 202-551-3635 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Julia Forbess, Esq. </TEXT> </DOCUMENT>
2024-06-17 - CORRESP - Stoke Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP STOKE THERAPEUTICS, INC. 45 Wiggins Avenue Bedford, MA 01730 June 17, 2024 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Office of Life Sciences Re: Stoke Therapeutics, Inc. Registration Statement on Form S-3 Filed June 13, 2024 File No. 333-280172 Via EDGAR - Acceleration Request Requested Date: June 20, 2024 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: Stoke Therapeutics, Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to make the above-captioned Registration Statement on Form S-3 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable. The Registrant hereby authorizes Robert A. Freedman or Julia Forbess, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration. The Registrant requests that it be notified of such effectiveness by a telephone call to Ms. Forbess at (415) 875-2420 or, in her absence, to Mr. Freedman at (206) 389-4524. * * * Sincerely, STOKE THERAPEUTICS, INC. By: /s/ Thomas Leggett Thomas Leggett Chief Financial Officer cc: Edward M. Kaye, Chief Executive Officer Jonathan Allan, General Counsel Stoke Therapeutics, Inc. Robert A. Freedman, Esq. Julia Forbess, Esq. Fenwick & West LLP
2024-06-17 - UPLOAD - Stoke Therapeutics, Inc. File: 333-280172
United States securities and exchange commission logo
June 17, 2024
Edward Kaye
Chief Executive Officer
Stoke Therapeutics, Inc.
45 Wiggins Avenue
Bedford, MA 01730
Re:Stoke Therapeutics, Inc.
Registration Statement on Form S-3
Filed June 13, 2024
File No. 333-280172
Dear Edward Kaye:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Jason Drory at 202-551-8342 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Julia Forbess
2023-11-17 - CORRESP - Stoke Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP Julia Forbess jforbess@fenwick.com | 415.875.2420 November 17, 2023 VIA EDGAR AND OVERNIGHT DELIVERY U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, DC 20549 Attention: Christina Chalk Shane Callaghan Re: Stoke Therapeutics, Inc. Schedule TO-I Filed November 2, 2023 File No. 005-91051 Ladies and Gentlemen: On behalf of Stoke Therapeutics, Inc. (the “Company”), we are concurrently transmitting herewith the Amendment No. 2 to the Company’s Tender Offer Statement on Schedule TO (the “ Amendment No. 2”). In this letter, we respond to the comments of the staff of the Commission (the “Staff”) contained in the Staff’s letter dated November 16, 2023 (the “Letter”) regarding the Company’s Tender Offer Statement on Schedule TO (File No. 005-91051) (the “Schedule TO-I”) submitted by the Company to the U.S. Securities and Exchange Commission (the “Commission”) on November 2, 2023. The numbered paragraphs below correspond to the numbered comments in the Letter, and the Staff’s comments are presented in bold italics. Capitalized terms used in this letter but not otherwise defined herein have the meanings set forth in the Schedule TO-I. U.S. Securities and Exchange Commission Attention: Christina Chalk, Shane Callaghan November 17, 2023 Page 2 Schedule TO-I filed November 2, 2023 General 1. The cross reference in Item 7(b) of Schedule TO to Section 6 of the Offering Memorandum appears to be inappropriate, as Section 6 of the Offering Memorandum sets forth the conditions to the consummation of the Exchange Offer rather than material conditions, if any, to any financing of consideration to be provided in the Exchange Offer. See Item 1007(b) of Regulation M-A. Please revise. In response to the Staff’s comment, the Company has revised the response to Item 7(b) of the Schedule TO-I in Amendment No. 2. Summary Term Sheet—Questions and Answers, page 5 2. Refer to the following disclosure made on pages 9-10 of the Exchange Offer under Question 10: “Unless we amend or terminate the Exchange Offer in accordance with its terms, we will grant you New RSUs in exchange for Eligible Options with respect to which you properly made a valid election (and did not validly revoke that election), effective as of the New RSU Grant Date, following the Expiration Time. However, it may take a few weeks from the Expiration Time for you to receive your New RSUs.” Please explain in your response letter how this payment process is consistent with your obligation to pay promptly under Rule 13e-4(f)(5). In response to the Staff’s comment, the Company has revised its disclosure on pages 9-10 of the Exchange Offer in Amendment No. 2. Procedures for Tendering Eligible Options, page 25 3. Refer to the following disclosure on page 26 of the Exchange Offer: “Subject to Rule 13e-4 under the Exchange Act, we also reserve the right to waive any of the conditions of the Exchange Offer or any defect or irregularity in any tender with respect to any particular Eligible Option or any particular Eligible Employee.” Please revise to avoid the implication that you may waive a condition of the offer as to one or some Eligible Employees, rather than generally waiving such offer condition. All conditions to the Exchange Offer must apply uniformly to all Eligible Employees. In response to the Staff’s comment, the Company has revised its disclosure on page 26 of the Exchange Offer in Amendment No. 2. Withdrawal Rights, page 27 4. Refer to the following disclosure made on page 27 of the Exchange Offer: “[I]f we have not accepted your tendered Eligible Options by 11:59 p.m. Eastern Time on December 28, 2023 (which is the 40th business day following the commencement of the offer), you may withdraw your Eligible Options at any time thereafter but prior to our acceptance.” It does not appear that December 28, 2023 is the 40th business day (as defined in Rule 13e- 4(a)(3)) after commencement of this Exchange Offer. Please revise or advise. 2 U.S. Securities and Exchange Commission Attention: Christina Chalk, Shane Callaghan November 17, 2023 Page 3 In response to the Staff’s comment, the Company has revised its disclosure on page 27 of the Exchange Offer in Amendment No. 2. Conditions of the Exchange Offer, page 28 5. On page 29 of the Exchange Offer, you have included a condition that will be triggered by “any general suspension of trading in, or limitation on prices for, securities on any national securities exchange or automated quotation system or in the over-the-counter market.” Please revise to explain what would be considered a limitation on prices for securities on any national securities exchange or automated quotation system or in the over-the-counter market, or delete. In response to the Staff’s comment, the Company has revised the condition to remove the reference to the limitation on prices on page 29 of the Exchange Offer in Amendment No. 2. 6. Refer to the following language in the condition on page 30 of the Exchange Offer: “any changes occur in our business, financial condition, assets, income, operations, prospects or stock ownership that, in our reasonable judgment, is or may be material to Stoke Therapeutics.” As drafted, the condition is extremely broad since it is not limited to negative changes. Please revise to outline how you will judge materiality in this context, or advise. In response to the Staff’s comment, the Company has revised its disclosure on page 30 of the Exchange Offer in Amendment No. 2 to clarify it only refers to adverse changes. 7. Refer to the following condition on page 30 of the Exchange Offer: “Any event or events occur that have resulted or may result, in our reasonable judgment, in a material impairment of the contemplated benefits of the Exchange Offer to Stoke Therapeutics . . . .” Revise to describe the “contemplated benefits of the Exchange Offer” for purposes of this offer condition. In response to the Staff’s comment, the Company has revised its disclosure on page 30 of the Exchange Offer in Amendment No. 2. 8. Refer to the following statement made on page 30 of the Exchange Offer: “We may waive the conditions, in whole or in part, at any time and from time to time prior to our acceptance of your tendered Eligible Options for exchange, whether or not we waive any other condition to the Exchange Offer.” If an offer condition is 3 U.S. Securities and Exchange Commission Attention: Christina Chalk, Shane Callaghan November 17, 2023 Page 4 “triggered” while the offer is pending, in our view, the offeror must promptly inform security holders whether it will assert the condition and terminate the offer, or waive it and continue. Reserving the right to waive a condition “at any time and from time to time” may be inconsistent with your obligation in this regard. Please confirm in your response letter that you will promptly notify target security holders if a condition is triggered while the Exchange Offer is pending. In response to the Staff’s comment, the Company confirms that it will promptly notify target security holders if a condition is triggered while the Exchange Offer is pending. Information Concerning Stoke Therapeutics; Financial Information, page 32 9. Refer to Item 10 of Schedule TO. To the extent that you are incorporating by reference financial statements in other filings by Stoke Therapeutics, revise to expressly do so and to identify where the specific information may be found within the applicable filing(s). See Instruction 3 to Item 10 of Schedule TO. In response to the Staff’s comment, the Company has revised Section 9 (“Information Concerning Stoke Therapeutics; Financial Information”) of the Exchange Offer to expressly incorporate by reference the financial statements and related management’s discussion and analysis of results of operations and financial condition included the Company’s Annual Report and Quarterly Reports. 10. See our last comment above. Where a filing person elects to incorporate by reference the information required by Item 1010(a) of Regulation M-A, all of the summarized financial information required by Item 1010(c) must be disclosed in the document furnished to security holders. See Instruction 6 to Item 10 of Schedule TO and telephone interpretation I.H.7 in the July 2001 supplement to our “Manual of Publicly Available Telephone Interpretations” available on the Commission’s website at http://www.sec.gov. Please revise the Offering Memorandum to include the information required by Item 1010(c) of Regulation M-A and disseminate the amended disclosure in the same manner as the original offer materials. In response to the Staff’s comment, the Company has revised Section 9 (“Information Concerning Stoke Therapeutics; Financial Information”) of the Exchange Offer to include summarized financial information and undertakes to disseminate the amended disclosure in the same manner as the original offer materials. 4 U.S. Securities and Exchange Commission Attention: Christina Chalk, Shane Callaghan November 17, 2023 Page 5 11. Please include the Company’s book value per share as of the date of the most recent balance sheet presented. See Item 1010(a)(4) of Regulation M-A. In response to the Staff’s comment, the Company has revised Section 9 (“Information Concerning Stoke Therapeutics; Financial Information”) of the Exchange Offer to include the book value per share of common stock as of September 30, 2023. 12. In your response letter, explain why you do not believe pro forma financial information is material in the context of the Exchange Offer, or revise to provide such information in the amended disclosure document. See Item 1010(b) of Regulation M-A and Item 10 of Schedule TO. In response to the Staff’s comment, the Company informs the Staff that the grant of New RSUs in connection with the exchange offer is not expected to result in an incremental compensation expense that would have a material impact on the Company’s reported net loss or require reporting of pro forma financial information. The Company designed an approach to exchange ratios for the Exchange Offer to result in a fair value of the New RSUs that will approximate the fair value of the eligible stock options that employees will surrender in the exchange based on the Black-Scholes valuation model. The Exchange Offer provides a “value for value” exchange, and the accounting fair value of the replacement options granted will be approximately equal to the fair value of the options that are surrendered at the time of the exchange, such that the impact on compensation expense, if any, will be immaterial to the financial statements taken as a whole. As disclosed in Section 11 (“Accounting Consequences of the Exchange Offer”) of the Exchange Offer, the Company cannot predict the exact amount of the charge (if any) that will result from the exchange offer as the fair value of the New RSUs and related incremental compensation expense, if any, will be determined on the New RSU Grant Date. Further, because the Company is currently in a net loss position and has been historically since its initial public offering, any net reduction in the outstanding number of stock options resulting from surrendered and cancelled stock options in the Exchange Offer will not have any impact to basic or diluted earnings per share calculations as the Company is in an anti-dilutive position. Interests of Directors and Executive Officers; Transactions and Arrangements Concerning Our Securities, page 33 13. Please revise the Offering Memorandum or Schedule TO to provide the information required by Item 1008(a) of Regulation M-A for each person named in response to Item 1003(a) of Regulation M-A and by each associate and majority-owned subsidiary of those persons, if applicable. In response to the Staff’s comment, the Company has revised Section 10 (“Interests of Directors and Executive Officers; Transactions and Arrangements Concerning Our Securities”) of the Exchange Offer to include the information required by Item 1008(a) of Regulation M-A for each of its executive officers and directors. * * * * * * * 5 U.S. Securities and Exchange Commission Attention: Christina Chalk, Shane Callaghan November 17, 2023 Page 6 Should the Staff have additional questions or comments regarding the foregoing, please do not hesitate to contact the undersigned at (415) 875-2420, or, in her absence, Rob Freedman at (206) 389-4524. Sincerely, /s/ Julia Forbess Julia Forbess FENWICK & WEST LLP Cc Edward M. Kaye, M.D., Chief Executive Officer Stephen J. Tulipano, Chief Financial Officer Jonathan Allan, General Counsel and Corporate Secretary Stoke Therapeutics, Inc. Effie Toshav, Esq. Rob Freedman, Esq. Fenwick & West LLP 6
2023-11-16 - UPLOAD - Stoke Therapeutics, Inc.
United States securities and exchange commission logo
November 16, 2023
Edward M. Kaye, M.D.
Chief Executive Officer
Stoke Therapeutics, Inc.
45 Wiggins Avenue
Bedford, Massachusetts 01730
Re:Stoke Therapeutics, Inc.
Schedule TO-I Filed November 2, 2023
File No. 005-91051
Dear Edward M. Kaye:
We have reviewed your filing and have the following comments.
Please respond to these comments by providing the requested information or advise us as
soon as possible when you will respond. If you do not believe our comments apply to your facts
and circumstances, please tell us why in your response.
After reviewing your response to these comments, we may have additional comments.
All defined terms used herein have the same meaning as in your offer materials, unless otherwise
indicated.
Schedule TO-I Filed November 2, 2023
General
1.The cross reference in Item 7(b) of Schedule TO to Section 6 of the Offering
Memorandum appears to be inappropriate, as Section 6 of the Offering Memorandum sets
forth the conditions to the consummation of the Exchange Offer rather than material
conditions, if any, to any financing of consideration to be provided in the Exchange Offer.
See Item 1007(b) of Regulation M-A. Please revise.
Summary Term Sheet - Questions and Answers, page 5
2.Refer to the following disclosure made on pages 9-10 of the Exchange Offer under
Question 10: “Unless we amend or terminate the Exchange Offer in accordance with its
terms, we will grant you New RSUs in exchange for Eligible Options with respect to
which you properly made a valid election (and did not validly revoke that election),
effective as of the New RSU Grant Date, following the Expiration Time. However, it may
take a few weeks from the Expiration Time for you to receive your New RSUs.” Please
FirstName LastNameEdward M. Kaye, M.D.
Comapany NameStoke Therapeutics, Inc.
November 16, 2023 Page 2
FirstName LastNameEdward M. Kaye, M.D.
Stoke Therapeutics, Inc.
November 16, 2023
Page 2
explain in your response letter how this payment process is consistent with your obligation
to pay promptly under Rule 13e-4(f)(5).
Procedures for Tendering Eligible Options, page 25
3.Refer to the following disclosure on page 26 of the Exchange Offer: "Subject to Rule 13e-
4 under the Exchange Act, we also reserve the right to waive any of the conditions of the
Exchange Offer or any defect or irregularity in any tender with respect to any particular
Eligible Option or any particular Eligible Employee." Please revise to avoid the
implication that you may waive a condition of the offer as to one or some Eligible
Employees, rather than generally waiving such offer condition. All conditions to the
Exchange Offer must apply uniformly to all Eligible Employees.
Withdrawal Rights, page 27
4.Refer to the following disclosure made on page 27 of the Exchange Offer: "[I]f we have
not accepted your tendered Eligible Options by 11:59 p.m. Eastern Time on December 28,
2023 (which is the 40th business day following the commencement of the offer), you may
withdraw your Eligible Options at any time thereafter but prior to our acceptance." It does
not appear that December 28, 2023 is the 40th business day (as defined in Rule 13e-
4(a)(3)) after commencement of this Exchange Offer. Please revise or advise.
Conditions of the Exchange Offer, page 28
5.On page 29 of the Exchange Offer, you have included a condition that will be triggered by
“any general suspension of trading in, or limitation on prices for, securities on any
national securities exchange or automated quotation system or in the over-the-counter
market.” Please revise to explain what would be considered a limitation on prices for
securities on any national securities exchange or automated quotation system or in the
over-the-counter market, or delete.
6.Refer to the following language in the condition on page 30 of the Exchange Offer: “any
changes occur in our business, financial condition, assets, income, operations, prospects or
stock ownership that, in our reasonable judgment, is or may be material to Stoke
Therapeutics.” As drafted, the condition is extremely broad since it is not limited to
negative changes. Please revise to outline how you will judge materiality in this context,
or advise.
7.Refer to the following condition on page 30 of the Exchange Offer: “Any event or events
occur that have resulted or may result, in our reasonable judgment, in a material
impairment of the contemplated benefits of the Exchange Offer to Stoke Therapeutics . . .
.” Revise to describe the "contemplated benefits of the Exchange Offer" for purposes of
this offer condition.
8.Refer to the following statement made on page 30 of the Exchange Offer: “We may waive
the conditions, in whole or in part, at any time and from time to time prior to our
FirstName LastNameEdward M. Kaye, M.D.
Comapany NameStoke Therapeutics, Inc.
November 16, 2023 Page 3
FirstName LastNameEdward M. Kaye, M.D.
Stoke Therapeutics, Inc.
November 16, 2023
Page 3
acceptance of your tendered Eligible Options for exchange, whether or not we waive any
other condition to the Exchange Offer.” If an offer condition is “triggered” while the offer
is pending, in our view, the offeror must promptly inform security holders whether it will
assert the condition and terminate the offer, or waive it and continue. Reserving the right
to waive a condition “at any time and from time to time” may be inconsistent with your
obligation in this regard. Please confirm in your response letter that you will promptly
notify target security holders if a condition is triggered while the Exchange Offer is
pending.
Information Concerning Stoke Therapeutics; Financial Information, page 32
9.Refer to Item 10 of Schedule TO. To the extent that you are incorporating by reference
financial statements in other filings by Stoke Therapeutics, revise to expressly do so and
to identify where the specific information may be found within the applicable filing(s).
See Instruction 3 to Item 10 of Schedule TO.
10.See our last comment above. Where a filing person elects to incorporate by reference the
information required by Item 1010(a) of Regulation M-A, all of the summarized financial
information required by Item 1010(c) must be disclosed in the document furnished to
security holders. See Instruction 6 to Item 10 of Schedule TO and telephone interpretation
I.H.7 in the July 2001 supplement to our “Manual of Publicly Available Telephone
Interpretations” available on the Commission’s website at http://www.sec.gov. Please
revise the Offering Memorandum to include the information required by Item 1010(c) of
Regulation M-A and disseminate the amended disclosure in the same manner as the
original offer materials.
11.Please include the Company’s book value per share as of the date of the most recent
balance sheet presented. See Item 1010(a)(4) of Regulation M-A.
12.In your response letter, explain why you do not believe pro forma financial information
is material in the context of the Exchange Offer, or revise to provide such information in
the amended disclosure document. See Item 1010(b) of Regulation M-A and Item 10
of Schedule TO.
Interests of Directors and Executive Officers; Transactions and Arrangements Concerning Our
Securities, page 33
13.Please revise the Offering Memorandum or Schedule TO to provide the information
required by Item 1008(a) of Regulation M-A for each person named in response to Item
1003(a) of Regulation M-A and by each associate and majority-owned subsidiary of those
persons, if applicable.
We remind you that the filing persons are responsible for the accuracy and adequacy of
their disclosures, notwithstanding any review, comments, action or absence of action by the staff.
FirstName LastNameEdward M. Kaye, M.D.
Comapany NameStoke Therapeutics, Inc.
November 16, 2023 Page 4
FirstName LastName
Edward M. Kaye, M.D.
Stoke Therapeutics, Inc.
November 16, 2023
Page 4
Please direct any questions to Christina Chalk at 202-551-3263 or Shane Callaghan at
202-330-1032.
Sincerely,
Division of Corporation Finance
Office of Mergers & Acquisitions
2022-05-26 - CORRESP - Stoke Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP STOKE THERAPEUTICS, INC. 45 Wiggins Avenue Bedford, MA 01730 May 26, 2022 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Office of Life Sciences Re: Stoke Therapeutics, Inc. Registration Statement on Form S-3 Filed May 20, 2022 File No. 333-265107 Via EDGAR - Acceleration Request Requested Date: May 31, 2022 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: Stoke Therapeutics, Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to make the above-captioned Registration Statement on Form S-3 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable. The Registrant hereby authorizes Robert A. Freedman or Julia Forbess, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration. Sincerely, STOKE THERAPEUTICS, INC. By: /s/ Stephen J. Tulipano Stephen J. Tulipano Chief Financial Officer cc: Edward M. Kaye, Chief Executive Officer Jonathan Allan, Deputy General Counsel Stoke Therapeutics, Inc. Robert A. Freedman, Esq. Julia Forbess, Esq. Fenwick & West LLP
2022-05-25 - UPLOAD - Stoke Therapeutics, Inc.
United States securities and exchange commission logo
May 25, 2022
Edward Kaye, M.D.
Chief Executive Officer
Stoke Therapeutics, Inc.
45 Wiggins Avenue
Bedford, MA 01730
Re:Stoke Therapeutics, Inc.
Registration Statement on Form S-3
Filed May 20, 2022
File No. 333-265107
Dear Dr. Kaye:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Michael Davis at 202-551-4385 or Celeste Murphy at 202-551-3257 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: Robert Freedman
2020-07-16 - CORRESP - Stoke Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP STOKE THERAPEUTICS, INC. 45 Wiggins Avenue Bedford, MA 01730 July 16, 2020 United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Attention: Abby Adams Office of Life Sciences Re: Stoke Therapeutics, Inc. Registration Statement on Form S-3 Filed July 10, 2020 File No. 333-239801 Via EDGAR - Acceleration Request Requested Date: July 20, 2020 Requested Time: 4:00 p.m. Eastern Time Ladies and Gentlemen: Stoke Therapeutics, Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission (the “Commission”) take appropriate action to make the above-captioned Registration Statement on Form S-3 effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable. The Registrant hereby authorizes Robert A. Freedman or Julia Forbess, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration. Sincerely, STOKE THERAPEUTICS, INC. By: /s/ Robin A. Walker Robin A. Walker Senior Vice President, Chief Legal Officer, Chief Compliance Officer and Secretary cc: Edward M. Kaye, Chief Executive Officer Stephen J. Tulipano, Chief Financial Officer Stoke Therapeutics, Inc. Robert A. Freedman, Esq. Julia Forbess, Esq. Fenwick & West LLP
2020-07-15 - UPLOAD - Stoke Therapeutics, Inc.
United States securities and exchange commission logo
July 15, 2020
Edward M. Kaye, M.D.
Chief Executive Officer
Stoke Therapeutics, Inc.
45 Wiggins Avenue
Bedford, MA 01730
Re:Stoke Therapeutics, Inc.
Registration Statement on Form S-3
Filed July 20, 2020
File No. 333-239801
Dear Dr. Kaye:
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 Abby Adams at (202) 551-6902 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2019-06-14 - CORRESP - Stoke Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP June 14, 2019 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, DC 20549 Re: Stoke Therapeutics, Inc. Registration Statement on Form S-1 (File No. 333-231700) Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended (the “Act”), we, as representatives of the several underwriters (the “Underwriters”), hereby join in the request of Stoke Therapeutics, Inc. with respect to the effective time of the above-referenced Registration Statement so that it will become effective June 18, 2019, at 4:00 p.m. Eastern Time, or as soon thereafter as practicable. In connection with this acceleration request and pursuant to Rule 460 under the Act, please be advised that, during the period from June 7, 2019 to the date of this letter, we have effected the distribution of approximately 1,636 copies of the preliminary prospectus, dated June 7, 2019, to prospective underwriters, dealers, institutions, and others. We were advised on June 7, 2019 by the Corporate Financing Department of the Financial Industry Regulatory Authority that it has reviewed the above-captioned proposed offering and that it has determined to raise no objections with respect to the fairness of the terms and arrangements of the offering. We, the undersigned, as representatives of the several Underwriters, have complied and will comply, and we have been informed by the participating Underwriters that they have complied and will comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended. [Remainder of Page Intentionally Left Blank] Very truly yours, J.P. MORGAN SECURITIES LLC COWEN AND COMPANY, LLC CREDIT SUISSE SECURITIES (USA) LLC on behalf of themselves and as representatives of the Underwriters J.P. MORGAN SECURITIES LLC By: /s/ John Whittaker Name: John Whittaker Title: Managing Director COWEN AND COMPANY, LLC By: /s/ Jason Fenton Name: Jason Fenton Title: Managing Director CREDIT SUISSE SECURITIES (USA) LLC By: /s/ Connie Chiang Name: Connie Chiang Title: Managing Director [Signature Page to Underwriters’ Acceleration Request Letter]
2019-06-14 - CORRESP - Stoke Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP Stoke Therapeutics, Inc. 45 Wiggins Avenue Bedford, MA 01730 June 14, 2019 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance Office of Healthcare & Insurance 100 F Street, NE Washington, DC 20549 Attention: Sonia Bednarowski Justin Dobbie Rolf Sunderwall Jim Rosenberg Re: Stoke Therapeutics, Inc. Registration Statement on Form S-1 (File No. 333-231700) originally filed May 23, 2019, as amended, and corresponding Registration Statement on Form 8-A (File No. 001-38938) filed June 11, 2019 Requested Date: June 18, 2019 Requested Time: 4:00 PM Eastern Time Ladies and Gentlemen: Stoke Therapeutics, Inc. (the “Registrant”) hereby requests that the Securities and Exchange Commission take appropriate action to declare the above-captioned Registration Statements on Form S-1 and Form 8-A effective at the “Requested Date” and “Requested Time” set forth above or as soon thereafter as practicable. The Registrant hereby authorizes Robert A. Freedman or Julia Forbess, both of whom are attorneys with the Registrant’s outside legal counsel, Fenwick & West LLP, to orally modify or withdraw this request for acceleration. The Registrant requests that it be notified of such effectiveness by a telephone call to Mr. Freedman at (650) 335-7292 or, in his absence, Ms. Forbess at (415)-875-2420. * * * Sincerely, STOKE THERAPEUTICS, INC. By: /s/ Stephen J. Tulipano Stephen J. Tulipano Chief Financial Officer cc: Edward M. Kaye, Chief Executive Officer Stoke Therapeutics, Inc. Robert A. Freedman, Esq. Effie Toshav, Esq. Julia Forbess, Esq. Fenwick & West LLP [Signature Page to Company Acceleration Request Letter]
2019-06-12 - CORRESP - Stoke Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP June 12, 2019 ROBERT A. FREEDMAN EMAIL: RFREEDMAN@FENWICK.COM Direct Dial: +1 (650) 335-7292 VIA EDGAR AND OVERNIGHT DELIVERY U.S. Securities and Exchange Commission Division of Corporation Finance Office of Healthcare & Insurance 100 F Street, NE Washington, DC 20549 Attention: Sonia Bednarowski Justin Dobbie Rolf Sundwall Jim Rosenberg Re: Stoke Therapeutics, Inc. Amendment No.1 to Registration Statement on Form S-1 Filed June 7, 2019 File No. 333-231700 Ladies and Gentlemen: We are submitting this letter on behalf of Stoke Therapeutics, Inc. (the “Company”) in response to the comments of the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) in its letter dated June 11, 2019 (the “Letter”) regarding the Company’s Amendment No. 1 to Registration Statement on Form S-1 (File No. 333-231700) filed with the Commission on June 7, 2019 (“Amendment No.1”), such Form S-1 initially filed with the Commission on May 23, 2019 (the “Registration Statement”). The Company advises the Staff that it has filed Amendment No. 2 (“Amendment No. 2”) to the Registration Statement on June 12, 2019. The numbered paragraphs below correspond to the numbered comments in the Staff’s Letter, and the Staff’s comments are presented in bolded italics. For the convenience of the Staff, we are also sending, by overnight courier, a copy of this letter and two copies of Amendment No. 2 in paper format, marked to show changes from Amendment No 1. In addition to addressing the comments raised by the Staff in the Letter, the Company has revised Amendment No. 1 to update certain other disclosures. Amendment No. 1 to Registration Statement on Form S-1 Prospectus Summary June 12, 2019 Page 2 The Offering, page 7 1. You reference a 9.95 for 1 reverse stock split effected on June 6, 2019. Please revise, if true, to state herein and throughout the filing including the notes to the consolidated financial statements that you effected a 1 for 9.95 reverse stock split. The Company acknowledges the Staff’s comment and advises the Staff that in response, it has revised its disclosure on pages 8, F-7, F-29 and F-40. Business License Agreements Cold Spring Harbor Laboratory, page 112 2. We note that, if you sublicense rights under the CSHL Agreement, you are obligated to pay a “low-double digit” percentage of the sublicense revenue to CSHL. Please revise the sublicense revenue range to reflect no more than a 10% range. The Company acknowledges the Staff’s comment and advises the Staff that in response, it has revised its disclosure on pages 112, F-16 and F-35. Exhibits and financial statement schedules, page II-4 3. Please revise your exhibit index to remove the reference to confidential treatment and to state that portions of the exhibits have been omitted pursuant to Item 601(b)(10) of Regulation S-K. Please also remove the references to “Confidential Treatment Requested” in Exhibits 10.8 and 10.9 and refile those exhibits accordingly. The Company acknowledges the Staff’s comment and advises the Staff that it has revised the exhibit index and Exhibits 10.8 and 10.9 accordingly to remove references to “Confidential Treatment Requested” and has refiled those exhibits with Amendment No. 2. * * * * * * * June 12, 2019 Page 3 Should the Staff have additional questions or comments regarding the foregoing, please do not hesitate to contact the undersigned at (650) 335-7292, or, in his absence, Julia Forbess at (415) 875-2420. Sincerely, /s/ Robert A. Freedman Robert A. Freedman Partner FENWICK & WEST LLP cc: Edward M. Kaye, Chief Executive Officer Stephen J. Tulipano, Chief Financial Officer Stoke Therapeutics, Inc. Effie Toshav, Esq. Julia Forbess, Esq. Fenwick & West LLP Deanna Kirkpatrick, Esq. Marcel Fausten, Esq. Davis Polk & Wardwell LLP
2019-06-11 - UPLOAD - Stoke Therapeutics, Inc.
June 11, 2019
Edward Kaye
Chief Executive Officer
Stoke Therapeutics, Inc.
45 Wiggins Avenue
Bedford, MA 01730
Re:Stoke Therapeutics, Inc.
Amendment No. 1 to Registration Statement on Form S-1
Filed June 7, 2019
File No. 333-231700
Dear Dr. Kaye:
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 June 3, 2019 letter.
Amendment No. 1 to Registration Statement on Form S-1
Prospectus Summary
The Offering, page 7
1.You reference a 9.95 for 1 reverse stock split effected on June 6, 2019. Please revise, if
true, to state herein and throughout the filing including the notes to the consolidated
financial statements that you effected a 1 for 9.95 reverse stock split.
Business
License Agreements
Cold Spring Harbor Laboratory, page 112
2.We note that, if you sublicense rights under the CSHL Agreement, you are obligated to
FirstName LastNameEdward Kaye
Comapany NameStoke Therapeutics, Inc.
June 11, 2019 Page 2
FirstName LastName
Edward Kaye
Stoke Therapeutics, Inc.
June 11, 2019
Page 2
pay a "low-double digit" percentage of the sublicense revenue to CSHL. Please revise the
sublicense revenue range to reflect no more than a 10% range.
Exhibits and financial statement schedules, page II-4
3.Please revise your exhibit index to remove the reference to confidential treatment and to
state that portions of the exhibits have been omitted pursuant to Item 601(b)(10) of
Regulation S-K. Please also remove the references to "Confidential Treatment Requested"
in Exhibits 10.8 and 10.9 and refile those exhibits accordingly.
You may contact Rolf Sundwall at 202-551-3105 or Jim Rosenberg at 202-551-3679 if
you have questions regarding comments on the financial statements and related matters. Please
contact Sonia Bednarowski at 202-551-3666 or Justin Dobbie, Legal Branch Chief, at 202-551-
3469 with any other questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2019-06-07 - CORRESP - Stoke Therapeutics, Inc.
CORRESP
1
filename1.htm
Response Letter
June 7, 2019
ROBERT A. FREEDMAN
EMAIL: RFREEDMAN@FENWICK.COM
Direct Dial: +1 (650) 335-7292
VIA EDGAR AND OVERNIGHT DELIVERY
U.S. Securities and Exchange Commission
Division of Corporation
Finance
Office of Healthcare & Insurance
100 F
Street, NE
Washington, DC 20549
Attention:
Sonia Bednarowski
Justin Dobbie
Rolf Sundwall
Jim Rosenberg
Re:
Stoke Therapeutics, Inc.
Registration Statement on Form S-1
Filed May 23, 2019
File No. 333-231700
Ladies and Gentlemen:
We are submitting this letter on behalf of Stoke Therapeutics, Inc. (the “Company”) in response to the comments of the
staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) in its letter dated June 3, 2019 (the “Letter”) regarding the Company’s
Registration Statement on Form S-1 (File No. 333-231700) initially filed with the Commission on May 23, 2019 (“Registration
Statement”). The Company advises the Staff that it has filed Amendment No. 1 (“Amendment No. 1”) to the Registration Statement on June 7, 2019. The numbered paragraphs
below correspond to the numbered comments in the Staff’s Letter, and the Staff’s comments are presented in bolded italics. For the convenience of the Staff, we are also sending, by overnight courier, a copy of this letter and two copies of
Amendment No. 1 in paper format, marked to show changes from the Registration Statement as initially filed.
In addition to
addressing the comments raised by the Staff in the Letter, the Company has revised the Registration Statement to update certain other disclosures.
Registration Statement on Form S-1
Description of capital stock
June 7, 2019
Page
2
Anti-takeover provisions
Restated certificate of incorporation and restated bylaw provisions, page 151
1.
We note your response to comment 8 in our letter dated April 17, 2019 that it is the
registrant’s position that the reference “to the fullest extent permitted by law” in your certificate of incorporation is sufficient to indicate that your exclusive forum provision will not apply to actions brought under the Exchange
Act. However, this may not be clear to investors. If you do not intend to state in your certificate of incorporation that the provision does not apply to actions arising under the Exchange Act, please tell us how you will inform investors in future
filings that the provision does not apply to any actions arising under the Exchange Act, as you do on page 153. In addition, please expand your risk factor on page 57 to state that your exclusive forum provision applies to claims under the
Securities Act and to address any uncertainty as to whether a court would enforce an exclusive forum provision with respect to claims under the Securities Act.
The Company acknowledges the Staff’s comment and advises the Staff that it in response, it has revised its disclosure in the risk factor on pages 57 and
58 titled “Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of us, which may be beneficial to our stockholders, more difficult and may prevent attempts by our stockholders to replace or
remove our current management.” In addition, the Company advises the Staff that it will include similar language in future filings. For example, the Company will include such language in the risk factors that it will include in each annual
report on Form 10-K (irrespective of any exemptions which may be available to the Company), and to the extent that the Company includes risk factors with its quarterly reports on Form 10-Q, as it currently anticipates doing for the foreseeable future, it will include the same language there. Furthermore, the Company will include the related disclosure on pages 154 and 155 in all
future filings that call for disclosure under Item 202 of Regulation S-K. The Company believes that by adding these disclosures to its future filings, investors will be informed that the reference
“to the fullest extent permitted by law” will not apply to actions brought under the Exchange Act.
* * * * * * *
June 7, 2019
Page
3
Should the Staff have additional questions or comments regarding the foregoing, please do not
hesitate to contact the undersigned at (650) 335-7292, or, in his absence, Julia Forbess at (415) 875-2420.
Sincerely,
/S/ Robert A. Freedman
Robert A. Freedman
Partner
FENWICK & WEST LLP
cc:
Edward M. Kaye, Chief Executive Officer
Stephen J. Tulipano, Chief Financial Officer
Stoke Therapeutics, Inc.
Effie Toshav, Esq.
Julia Forbess, Esq.
Fenwick & West LLP
Deanna Kirkpatrick, Esq.
Marcel Fausten, Esq.
Davis Polk & Wardwell LLP
2019-06-03 - UPLOAD - Stoke Therapeutics, Inc.
June 3, 2019
Edward Kaye
Chief Executive Officer
Stoke Therapeutics, Inc.
45 Wiggins Avenue
Bedford, MA 01730
Re:Stoke Therapeutics, Inc.
Registration Statement on Form S-1
Filed May 23, 2019
File No. 333-231700
Dear Dr. Kaye:
We have reviewed your registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and
circumstances or do not believe an amendment is appropriate, please tell us why in your
response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments. Unless we note
otherwise, our references to prior comments are to comments in our May 14, 2019 letter.
Registration Statement on Form S-1
Description of capital stock
Anti-takeover provisions
Restated certificate of incorporation and restated bylaw provisions, page 151
1.We note your response to comment 8 in our letter dated April 17, 2019 that it is the
registrant’s position that the reference “to the fullest extent permitted by law” in your
certificate of incorporation is sufficient to indicate that your exclusive forum provision
will not apply to actions brought under the Exchange Act. However, this may not be clear
to investors. If you do not intend to state in your certificate of incorporation that the
provision does not apply to actions arising under the Exchange Act, please tell us how you
will inform investors in future filings that the provision does not apply to any actions
FirstName LastNameEdward Kaye
Comapany NameStoke Therapeutics, Inc.
June 3, 2019 Page 2
FirstName LastName
Edward Kaye
Stoke Therapeutics, Inc.
June 3, 2019
Page 2
arising under the Exchange Act, as you do on page 153. In addition, please expand your
risk factor on page 57 to state that your exclusive forum provision applies to claims under
the Securities Act and to address any uncertainty as to whether a court would enforce an
exclusive forum provision with respect to claims under the Securities 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.
You may contact Rolf Sundwall at 202-551-3105 or Jim Rosenberg at 202-551-3679 if
you have questions regarding comments on the financial statements and related matters. Please
contact Sonia Bednarowski at 202-551-3666 or Justin Dobbie at 202-551-3469 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2019-06-03 - CORRESP - Stoke Therapeutics, Inc.
CORRESP 1 filename1.htm Cheap Stock Letter June 3, 2019 CERTAIN PORTIONS OF THIS LETTER AS FILED VIA EDGAR HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR THE OMITTED PORTIONS, WHICH HAVE BEEN REPLACED WITH THE FOLLOWING PLACEHOLDER: “[*].” VIA EDGAR AND OVERNIGHT DELIVERY Securities and Exchange Commission Division of Corporation Finance Office of Healthcare & Insurance 100 F Street, NE Washington, DC 20549 Attention: Sonia Bednarowski Justin Dobbie Rolf Sundwall Jim Rosenberg Re: Stoke Therapeutics, Inc. Registration Statement on Form S-1 Filed May 23, 2019 File No. 333-231700 Ladies and Gentlemen: On behalf of Stoke Therapeutics, Inc. (the “Company”), we submit this letter to assist the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) in its review of the Company’s Registration Statement on Form S-1 (File No. 333-231700) (the “Registration Statement”), to further address comment 10 of the Staff set forth in its letter to the Company dated April 17, 2019, concerning valuation considerations related to the Company’s equity awards. For the convenience of the Staff, we are providing to the Staff by overnight delivery copies of this letter. Because of the commercially sensitive nature of 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 and the Freedom of Information Act. CONFIDENTIAL TREATMENT REQUESTED BY STOKE THERAPEUTICS, INC. STOKE-1 Securities and Exchange Commission Division of Corporation Finance June 3, 2019 Page 2 The Company advises the Staff that the Company currently anticipates that it will include an expected price range in its preliminary prospectus (the “Preliminary Prospectus”) for the proposed initial public offering (the “IPO”) that will be between approximately $[*] and $[*] per share after effecting a proposed approximate [*]-to-1 reverse stock split (the “Price Range”). The Company plans to effect the reverse stock split in connection with its IPO pursuant to a future amendment of the Company’s certificate of incorporation that will be filed with the Secretary of State of the State of Delaware before filing the Preliminary Prospectus with the Commission (the “Stock Split”). The share numbers and stock prices set forth in this letter reflect the Stock Split and are all post-split. The Price Range has been determined based, in part, upon current market conditions, recent public offerings of other comparable companies and input received from the lead underwriters of the proposed offering, including discussions that took place on May 31, 2019 between senior management of the Company, the Board of Directors of the Company (the “Board”) and representatives of J.P. Morgan Securities LLC, Cowen and Company, LLC and Credit Suisse Securities (USA) LLC, the lead underwriters. Prior to May 31, 2019, the Company had not held formal discussions with the underwriters regarding a price range for the IPO. The Price Range does not take into account the current lack of liquidity for the Company’s common stock and assumes a successful initial public offering as of the date of that discussion with no weighting attributed to any other outcome for the Company’s business, such as remaining a privately held company. The Company expects to include a bona fide price range in an amendment to the Registration Statement that would shortly precede the commencement of the Company’s public marketing process, which it anticipates could commence as soon as [*]. Such price range could differ from the Price Range based on then-current market conditions, continuing discussions with the lead underwriters and further business developments impacting the Company. We supplementally advise the Staff that, as described on pages 81-85 of the Registration Statement, for all periods prior to the IPO, the fair values of the shares of common stock underlying the Company’s share-based awards were estimated on each grant date by the Board. To determine the fair value of the Company’s common stock underlying option grants, the Board considered, among other things, timely valuations of the Company’s common stock prepared by an unrelated third-party valuation firm in accordance with the guidance provided by the American Institute of Certified Public Accountants Practice Guide, Valuation of Privately-Held-Company Equity Securities Issued as Compensation. Given the absence of a public trading market for the Company’s common stock, the Board exercised reasonable judgment and considered a number of objective and subjective factors to determine the best estimate of the fair value of the Company’s common stock, including important developments in the Company’s operations, its stage of development, valuations performed by an independent third party valuation firm, sales of the Company’s preferred stock, actual operating results and financial performance, the conditions in the life sciences and biotechnology industry sectors and the economy in general, the stock price performance and volatility of comparable public companies, the lack of liquidity of the Company’s common stock, and the likelihood of achieving a liquidity event, such as an initial public offering or sale. The following table summarizes the grant of options by the Company since January 1, 2018 (on a post-Stock Split basis): CONFIDENTIAL TREATMENT REQUESTED BY STOKE THERAPEUTICS, INC. STOKE- 2 Securities and Exchange Commission Division of Corporation Finance June 3, 2019 Page 3 Date of Grant Number of Shares Subject to Stock Options Granted Exercise Price Per Share Fair Value Per Share Valuation Date April 2, 2018 [*] [*] [*] January 31, 2018 July 3, 2018 [*] [*] [*] January 31, 1018 December 12, 2018 [*] [*] [*] October 22, 2018 January 22, 2019 [*] [*] [*] October 22, 2018 March 18, 2019 [*] [*] [*] February 11, 2019 March 25, 2019 [*] [*] [*] February 11, 2019 April 29, 2019 [*] [*] [*] April 16, 2019 May 14, 2019 [*] [*] [*] April 16, 2019 June 4, 2019* [*] [*] [*] Anticipated Preliminary Prospectus Price Range *Representing ordinary course new hire grants anticipated to be made by the Company’s Board on such date. The Company used the following valuation and allocation methods for each of the valuation reports: For the January 2018 valuation, the Company employed an option pricing method (“OPM”) framework, given the very wide range of possible future exit events, and utilized the back-solve method for inferring and allocating the equity value predicated on the Series A-2 convertible preferred stock financing (the “Series A-2 Financing”) that closed immediately prior to the valuation date. This method was selected as the Company’s management concluded that the Series A-2 Financing was an arm’s-length transaction. Furthermore, as of the valuation date the Company was at an early stage of development and future liquidity events were difficult to forecast. Application of the OPM back-solve method involves making assumptions for the expected time to liquidity, volatility and risk-free rate and then solving for the value of equity such that value for the Series A-2 Financing equals the amount paid. For the January 2018 valuation and for purposes of the OPM allocation of total equity value determined with reference to the Series A-2 Financing, the Company assumed a 57% volatility rate and a 1.5-year estimated term. The Company then reflected a probability weighted average discount for lack of marketability (“DLOM”) of 35% to arrive at a $[*] per share valuation. CONFIDENTIAL TREATMENT REQUESTED BY STOKE THERAPEUTICS, INC. STOKE- 3 Securities and Exchange Commission Division of Corporation Finance June 3, 2019 Page 4 For the October 2018 valuation, the independent third-party valuation specialist used a hybrid method of two potential liquidity outcomes: a trade-sale scenario predicated on the Company’s arm’s length Series B convertible preferred stock financing (the “Series B Financing”) that closed just prior to the valuation date and an IPO scenario with reference to recent IPO transactions in the biotechnology and pharmaceutical industry and considering the Company’s preclinical stage of development. Under the hybrid method, the per share value calculated under the two scenarios were weighted based on expected exit outcomes and the quality of the information specific to each allocation methodology to arrive at a final estimated fair value per share value of the Company’s common stock before a DLOM is applied. For the October 2018 valuation, the Company (i) assigned a 90% probability of occurrence to the trade-sale scenario, with a 60% volatility rate and a 2-year estimated term applied within the OPM, then reflected a probability weighted average DLOM of 35%; and (ii) the Company assigned a 10% probability of occurrence to the IPO scenario, with a 30% weighted average cost of capital and a 0.88-year estimated term to an IPO event, then reflected a probability weighted average DLOM of 15%. For the February 2019 valuation, the independent third-party valuation specialist again used a hybrid method of two potential liquidity outcomes: a trade-sale scenario predicated on the Series B Financing and an IPO scenario with reference to recent IPO transactions in the biotechnology and pharmaceutical industry and considering the Company’s preclinical stage of development. Under the hybrid method, the per share values calculated under the two scenarios were weighted based on expected exit outcomes and the quality of the information specific to each allocation methodology to arrive at a final estimated fair value per share value of the Company’s common stock before a DLOM is applied. For the February 2019 valuation, the Company (i) assigned a 65% probability of occurrence to the trade-sale scenario, with a 61% volatility rate and a 1.75-year estimated term applied within the OPM, then reflected a probability weighted average DLOM of 30%; and (ii) the Company assigned a 35% probability of occurrence to the IPO scenario, with a 25% weighted average cost of capital and a 0.38-year estimated term to an IPO event, then reflected a probability weighted average DLOM of 12.5%. For the April 2019 valuation, the independent third-party valuation specialist again used a hybrid method of two potential liquidity outcomes: a trade-sale scenario predicated on the Series B Financing and an IPO scenario with reference to recent IPO transactions in the biotechnology and pharmaceutical industry and considering the Company’s preclinical stage of development. Under the hybrid method, the per share values calculated under the two scenarios were weighted based on expected exit outcomes and the quality of the information specific to each allocation methodology to arrive at a final estimated fair value per share value of the Company’s common stock before a DLOM is applied. For the April 2019 valuation, the Company (i) assigned a 40% probability of occurrence to the trade-sale scenario, with a 61% volatility rate and a 1.75-year estimated term applied within the OPM, then reflected a probability weighted average DLOM of 25%; and (ii) the Company assigned a 60% probability of occurrence to the IPO scenario, with a 25% weighted average cost of capital and a 0.25-year estimated term to an IPO event, then reflected a probability weighted average DLOM of 7.5%. The Company has not granted any options since May 2019 and does not currently intend to grant any options other than those in the ordinary course for newly hired employees anticipated on June 4, 2019, which it expects to total [*] shares, and to be valued at the midpoint of the Price Range. The Company submits that the primary reason for the difference between the fair value per share used for the stock options granted in April and May 2019 and the midpoint of the Price Range are: CONFIDENTIAL TREATMENT REQUESTED BY STOKE THERAPEUTICS, INC. STOKE- 4 Securities and Exchange Commission Division of Corporation Finance June 3, 2019 Page 5 • Differences in the valuation methodologies, assumptions and inputs used by the underwriters in their valuation analysis discussed with the Company and used to determine the Price Range, which assume a successful IPO as of today’s date with no weighting attributed to any other outcome for the Company’s business, such as remaining a privately held company, compared to the valuation methodologies, assumptions and inputs used in the valuations determined by the Board as described above in connection with the description of methodologies used. • The Price Range necessarily assumes that the IPO has occurred and a public market for the Company’s common stock has been created and, therefore, excludes any marketability or liquidity discount for the Company’s common stock, which was appropriately taken into account in the Board’s historical determinations of fair value. • The Company’s consideration of various objective and subjective factors in the previous fair value determinations, as described above, that were not applicable to the determination of the Price Range. • The expected proceeds of a successful IPO would substantially increase the Company’s cash balances. In addition, the completion of an IPO would potentially provide the Company with readier access to the public equity markets. The Price Range reflects the fact that investors may be willing to purchase shares in the IPO at a per share price that takes into account other factors that were not expressly considered in the Company’s prior valuations as a private company, and are not objectively determinable and that valuation models are not able to quantify with any level of certainty. As such, taking into account all of the above, the Company submits that it believes that its determination of the fair value of the Common Stock for financial reporting purposes is appropriate and it has properly reflected the stock-based compensation expense for its historical grants. CONFIDENTIAL TREATMENT REQUESTED BY STOKE THERAPEUTICS, INC. STOKE- 5 Securities and Exchange Commission Division of Corporation Finance June 3, 2019 Page 6 ********* Should the Staff have additional questions or comments regarding the foregoing, please do not hesitate to contact the undersigned at (650) 335-7292, or, in his absence, Julia Forbess at (415) 875-2420. Sincerely, FENWICK & WEST LLP /s/ Robert A. Freedman Robert A. Freedman Partner cc: Edward M. Kaye, M.D., Chief Executive Officer Stephen J. Tulipano, Chief Financial Officer Stoke Therapeutics, Inc. Julia Forbess Fenwick & West LLP Deanna Kirkpatrick Marcel Fausten Davis Polk & Wardwell LLP CONFIDENTIAL TREATMENT REQUESTED BY STOKE THERAPEUTICS, INC. STOKE- 6
2019-05-23 - CORRESP - Stoke Therapeutics, Inc.
CORRESP 1 filename1.htm CORRESP May 23, 2019 ROBERT A. FREEDMAN EMAIL: RFREEDMAN@FENWICK.COM Direct Dial: +1 (650) 335-7292 VIA EDGAR AND OVERNIGHT DELIVERY U.S. Securities and Exchange Commission Division of Corporation Finance Office of Healthcare & Insurance 100 F Street, NE Washington, DC 20549 Attention: Sonia Bednarowski Justin Dobbie Rolf Sundwall Jim Rosenberg Re: Stoke Therapeutics, Inc. Amendment No. 1 to Draft Registration Statement on Form S-1 Submitted April 30, 2019 CIK No. 0001623526 Ladies and Gentlemen: We are submitting this letter on behalf of Stoke Therapeutics, Inc. (the “Company”) in response to the comments of the staff (the “Staff”) of the U.S. Securities and Exchange Commission (the “Commission”) in its letter dated May 14, 2019 (the “Letter”) regarding Amendment No. 1 to the Company’s Draft Registration Statement on Form S-1 (CIK No. 0001623526) as confidentially submitted to the Commission on April 30, 2019 (“Amendment No. 1”). The Company advises the Staff that it publicly filed its Registration Statement on Form S-1 (the “Registration Statement”) on May 23, 2019. The numbered paragraphs below correspond to the numbered comments in the Staff’s letter and the Staff’s comments are presented in bolded italics. For the convenience of the Staff, we are also sending, by overnight courier, a copy of this letter and two copies of the Registration Statement in paper format, marked to show changes from Amendment No. 1. In addition to addressing the comments raised by the Staff in the Letter, the Company has revised the Registration Statement to update certain other disclosures. May 23, 2019 Page 2 Amendment No. 1 to Draft Registration Statement on Form S-1 Prospectus Summary Company overview, page 1 1. Please balance your statement that you believe you have the first genetic medicine with the potential to significantly reduce the occurrence of seizures for Dravet syndrome patients and to address the severe intellectual and developmental disabilities of the disease by clarifying here that you are in an early stage of your development and that to date you have only conducted preclinical studies for your product candidate. The Company acknowledges the Staff’s comment and advises the Staff that it has revised its disclosure on page 1 of the Registration Statement to balance this statement as indicated. Business STK-001: Preclinical data, page 100 2. Please disclose how many groups of pre-pubescent monkeys were administered with a single dose of STK-001 and how many control groups you used in the preclinical study described on page 103. The Company acknowledges the Staff’s comment and advises the Staff that it has revised its disclosure on page 105 of the Registration Statement to provide additional detail about the monkey groups. Description of capital stock Anti-takeover provisions Restated certificate of incorporation and restated bylaw provisions, page 147 3. We continue to consider your response to our prior comment 8. Please note that we may have additional comments. The Company acknowledges that the Staff will continue to consider the Company’s response to prior comment 8 and may have further comments. Notes to Consolidated Financial Statements 8. Convertible preferred stock Liquidation, page F-18 4. Please demonstrate to us why you believe that common shareholders hold a majority of the board seats and, as such, that the company controls the vote of the Board of Directors and any deemed liquidation event. As of December 31, 2018, it appears that only two board seats elected are controlled by common shareholders. In this regard, it appears that pursuant to articles 3.2.3 and 3.2.4 of your certificate of incorporation (exhibit 3.1) that the other four board seats elected are controlled by the preferred shareholders or effectively controlled by preferred shareholders voting together with common stock as a single class given the number of shares of preferred entitled to vote on an as-converted basis. May 23, 2019 Page 3 The Company acknowledges the Staff’s comment and provides the Staff with the following explanation: The Company’s Second Amended and Restated Voting Agreement dated October 22, 2018, among the Company, the preferred stockholders and certain common stockholders (the “Agreement”) contractually dictates how the preferred stockholders and other stockholders must vote their shares with respect to the election of members of the Board of Directors (the “Board”) in connection with any voting rights they have set forth in the Company’s certificate of incorporation. Despite the fact that the preferred stockholders hold a majority of the outstanding shares of the Company, the parties to the Agreement must vote all of their shares for members of the Board as follows: Section 1.2 (a) of the Agreement indicates that two people designated by the preferred shareholders shall be elected as directors to the Board, “Two people designated by Apple Tree Partners IV, L.P., a Cayman Islands limited partnership (“ATP”), which individuals shall initially be Seth L. Harrison, M.D. and Samuel W. Hall, Ph.D., for so long as such Stockholder and its Affiliates continue to own beneficially, in the aggregate, at least a number of shares of Preferred Stock equal to 25% of the total number of shares of Preferred Stock issued to such Stockholder and its Affiliates calculated as of the date of this Agreement, in the aggregate”; Section 1.2 (b) of the Agreement references the appointment of Adrian R. Krainer by the holders of the common stock as a director to the Board, “One person designated by the holders of a majority of the Shares of Common Stock held by the Key Holders, which individual shall initially be Adrian R. Krainer, for so long as the Key Holders who are then providing services to the Company as officers, employees or consultants hold at least 15% of the then-outstanding shares of Common Stock (as adjusted for any stock splits, stock dividends, recapitalizations or the like)”; Section 1.2 (c) of the Agreement references the appointment of Edward Kaye, M.D. as CEO Director to the Board of Directors, “The Company’s Chief Executive Officer, who shall initially be Edward Kaye, M.D. (the “CEO Director”), provided that if for any reason the CEO Director shall cease to serve as the Chief Executive Officer of the Company, each of the Stockholders shall promptly vote their respective Shares (i) to remove the former Chief Executive Officer from the Board if such person has not resigned as a member of the Board; and (ii) to elect such person’s replacement as Chief Executive Officer of the Company as the new CEO Director”; Section 1.2 (d) references the appointment of Arthur A. Levin, Ph.D. and Arthur Tzianabos, Ph.D. as Directors to the Board, “Three individuals not otherwise Affiliates (as defined below) of the Company or of any Investor, two of whom shall be mutually acceptable to the Company and ATP, which individuals shall initially be Arthur A. Levin, Ph.D. and Arthur Tzianabos, Ph.D., and one of whom shall be nominated by a majority of the remaining members of the Board and mutually acceptable to the holders of a majority of the outstanding shares of Series B Preferred Stock, which seat shall initially be vacant.” Section 1.2, last paragraph, defines an “Affiliate”. “For purposes of this Agreement, an individual, firm, corporation, partnership, association, limited liability company, trust or any other entity (collectively, a “Person”) shall be deemed an “Affiliate” of another Person who, directly or indirectly, controls, is controlled by or is under common control with such Person, including, without limitation, any general partner, managing member, officer or director of such Person or any account, fund, venture capital fund or registered investment company now or hereafter existing that is controlled by one or more general partners, managing members or investment advisers of, or shares the same management company or investment adviser with, such Person.” May 23, 2019 Page 4 As of December 31, 2018, the Company had, and as of today the Company has, six directors. None of the directors referenced in Sections 1.2(b), (c) or (d) of the Agreement were or are affiliated with the preferred shareholders nor do any of those directors hold preferred shares. As a result, the Company considers that the preferred stockholders hold a minority of the seats, two, on the Board, while the common shareholders combined with the mutually agreed upon members of the Board hold a majority, four, of such seats. In our view, at the balance sheet date of December 31, 2018, the composition of the Board is such that the preferred shareholders did not control the Board through direct representation or through other rights. Accordingly, as of December 31, 2018, the preferred stockholders could not control the vote of the Board and could not effectuate a deemed liquidation and cause a redemption. As such, redemption provision events were in the control of the Company and as of December 31, 2018, the Company therefore considered permanent equity classification for its preferred stock to be appropriate under these facts and circumstances. Given the above explanation, the Company advises the Staff that it has revised its disclosure on page 129 of the Registration Statement to modify the board composition language. The Company also advises the Staff that it has revised its disclosure on page F-19 of the Registration Statement to conform the redemption language. Under separate cover, the Company has concurrently herewith supplementally provided the Staff with a copy of the Agreement. The Company respectfully requests that the Staff destroy such materials upon completion of its review. * * * * * * * May 23, 2019 Page 5 Should the Staff have additional questions or comments regarding the foregoing, please do not hesitate to contact the undersigned at (650) 335-7292, or, in his absence, Julia Forbess at (415) 875-2420. Sincerely, /s/ Robert A. Freedman Robert A. Freedman Partner FENWICK & WEST LLP cc: Edward M. Kaye, Chief Executive Officer Stephen J. Tulipano, Chief Financial Officer Stoke Therapeutics, Inc. Effie Toshav, Esq. Julia Forbess, Esq. Fenwick & West LLP Deanna Kirkpatrick, Esq. Marcel Fausten, Esq. Davis Polk & Wardwell LLP
2019-05-14 - UPLOAD - Stoke Therapeutics, Inc.
May 14, 2019
Edward Kaye
Chief Executive Officer
Stoke Therapeutics, Inc.
45 Wiggins Avenue
Bedford, MA 01730
Re:Stoke Therapeutics, Inc.
Amendment No. 1 to Draft Registration Statement on Form S-1
Submitted April 30, 2019
CIK No. 0001623526
Dear Dr. Kaye:
We have reviewed your amended draft registration statement and have the following
comments. In some of our comments, we may ask you to provide us with information so we
may better understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments. Unless we note otherwise, our references to prior comments are to comments in our
April 17, 2019 letter.
Amendment No. 1 to Draft Registration Statement on Form S-1
Prospectus summary
Company overview, page 1
1.Please balance your statement that you believe you have the first genetic medicine with
the potential to significantly reduce the occurrence of seizures for Dravet syndrome
patients and to address the severe intellectual and developmental disabilities of the disease
by clarifying here that you are in an early stage of your development and that to date you
have only conducted preclinical studies for your product candidate.
FirstName LastNameEdward Kaye
Comapany NameStoke Therapeutics, Inc.
May 14, 2019 Page 2
FirstName LastName
Edward Kaye
Stoke Therapeutics, Inc.
May 14, 2019
Page 2
Business
STK-001: Preclinical data, page 100
2.Please disclose how many groups of pre-pubescent monkeys were administered with a
single dose of STK-001 and how many control groups you used in the preclinical study
described on page 103.
Description of capital stock
Anti-takeover provisions
Restated certificate of incorporation and restated bylaw provisions, page 147
3.We continue to consider your response to our prior comment 8. Please note that we may
have additional comments.
Notes to Consolidated Financial Statements
8. Convertible preferred stock
Liquidation, page F-18, page F-18
4.Please demonstrate to us why you believe that common shareholders hold a majority of
the board seats and, as such, that the company controls the vote of the Board of Directors
and any deemed liquidation event. As of December 31, 2018, it appears that only two
board seats elected are controlled by common shareholders. In this regard, it appears that
pursuant to articles 3.2.3 and 3.2.4 of your certificate of incorporation (exhibit 3.1) that
the other four board seats elected are controlled by the preferred shareholders or
effectively controlled by preferred shareholders voting together with common stock as a
single class given the number of shares of preferred entitled to vote on an as-converted
basis.
You may contact Rolf Sundwall at 202-551-3105 or Jim Rosenberg at 202-551-3679 if
you have questions regarding comments on the financial statements and related matters. Please
contact Sonia Bednarowski at 202-551-3666 or Justin Dobbie at 202-551-3469 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
2019-04-17 - UPLOAD - Stoke Therapeutics, Inc.
April 17, 2019
Edward Kaye
Chief Executive Officer
Stoke Therapeutics, Inc.
45 Wiggins Avenue
Bedford, MA 01730
Re:Stoke Therapeutics, Inc.
Draft Registration Statement on Form S-1
Submitted March 26, 2019
CIK No. 0001623526
Dear Dr. Kaye:
We have reviewed your draft registration statement and have the following comments. In
some of our comments, we may ask you to provide us with information so we may better
understand your disclosure.
Please respond to this letter by providing the requested information and either submitting
an amended draft registration statement or publicly filing your registration statement on
EDGAR. If you do not believe our comments apply to your facts and circumstances or do not
believe an amendment is appropriate, please tell us why in your response.
After reviewing the information you provide in response to these comments and your
amended draft registration statement or filed registration statement, we may have additional
comments.
Draft Registration Statement on Form S-1
Market and industry data, page ii
1.We note your disclosure that you commissioned a report by Health Advances LLC.
Please file a consent by Health Advances LLC as an exhibit to your registration statement
pursuant to Rule 436 of the Securities Act.
Prospectus summary
Company overview, page 1
2.You state that current treatments for Dravet syndrome provided by your competitors
perform "very poorly." Please provide us with your basis for this characterization of their
performance or revise your disclosure.
FirstName LastNameEdward Kaye
Comapany NameStoke Therapeutics, Inc.
April 17, 2019 Page 2
FirstName LastNameEdward Kaye
Stoke Therapeutics, Inc.
April 17, 2019
Page 2
Advantages of TANGO, page 2
3.Please revise this section and throughout to remove comparisons of your ASOs to other
product candidates, products and treatments if you have not conducted head-to-head
clinical trials. For example, we note your statement on page 2 that TANGO may have
several key advantages over existing and emerging therapeutic modalities, your disclosure
on page 88 that your product candidate "has the potential to result in significantly
improved outcomes compared to existing antipileptic drugs," and your disclosure on page
102 that "[b]y comparison to the approved drug SPINRAZA, STK-001 possesses less
predicted off-target activities."
Our precision medicine platform
Treatment of autosomal dominant haploinsufficiency diseases with TANGO, page 2
4.Your statement on page 3 that ASO delivery to the CNS is particularly well-precedented
with one FDA-approved drug creates the implication that your drug candidate will also be
approved by the FDA. In addition, your statement on page 2 that your technology can
provide a single-drug approach for diseases that are caused by many loss-of-function
mutations in a single gene, the inclusion of your "TANGO Technology" as a current or
emerging medicine in your chart on page 90 and your statement on page 100 that your
precision medicine approach may have a profound impact on individuals and families
imply that your current and future product candidates will be approved by the FDA. Such
statements are inappropriate given the stage of development of your product candidates.
Revise these statements and all other similar statements to eliminate such implication.
Our Programs
Dravet syndrome--STK-001, page 3
5.We note your disclosure on page 3 that you plan to apply for Orphan Drug Designation
from the FDA and that you plan to discuss expedited regulatory pathways with regulatory
authorities such as Fast Track Designation and Breakthrough Therapy Designation.
Please disclose here and throughout, if true, that the FDA has not given any indication as
to whether your product candidate will receive an orphan drug designation or be permitted
to use expedited regulatory pathways.
Implications of being an emerging growth company and smaller reporting company, page 5
6.Please 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.
FirstName LastNameEdward Kaye
Comapany NameStoke Therapeutics, Inc.
April 17, 2019 Page 3
FirstName LastNameEdward Kaye
Stoke Therapeutics, Inc.
April 17, 2019
Page 3
Risk factors
Risks related to our intellectual property
Our owned and in-licensed patents and patent applications, page 36
7.Please clarify what you mean by your disclosure that your in-licensed patent and patent
applications generally cover the use of STK-001 but do not specifically cover STK-001 or
its use.
Risks related to our common stock and this offering
Anti-takeover provision in our charter documents, page 57
8.We note your disclosure here and on page 147 that your restated certificate of
incorporation will contain an exclusive forum provision. Please disclose whether these
provisions apply to actions arising under the Securities Act or Exchange Act. If these
provisions do not apply to actions arising under the Securities Act or Exchange Act,
please also ensure that the exclusive forum provisions in the certificate of incorporation
state this clearly. Please also file a copy of your amended and restated certificate of
incorporation with your next amendment or tell us when you plan to do so. Note that we
may have further comment after review of this document and your revised disclosure.
Use of Proceeds, page 61
9.Please clarify what you mean by "demonstrate clinical proof of concept" by clarifying
whether you are referring to preclinical studies or clinical trials.
Management's discussion and analysis of financial condition and results of operations
Critical accounting policies and significant judgments and estimates
Determination of the fair value of common stock, page 81
10.Once you have an estimated offering price or range, please explain to us the reasons for
any differences between the recent valuations of your common stock 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.
Business, page 86
11.Please revise to disclose the material terms of your sponsored research agreement with the
University of Michigan, and file the agreement as an exhibit to your registration
statement, if required.
Our precision medicine platform
Tango mechanisms of action, page 93
12.Please balance the disclosure in this section by stating that you have only one product
FirstName LastNameEdward Kaye
Comapany NameStoke Therapeutics, Inc.
April 17, 2019 Page 4
FirstName LastNameEdward Kaye
Stoke Therapeutics, Inc.
April 17, 2019
Page 4
candidate and that this product candidate is still in preclinical studies.
Dravet syndrome disease overview
STK-001: Preclinical data, page 100
13.Please revise your disclosure of your preclinical studies by identifying the number of mice
in each group, as opposed to a range, and the number of groups tested as well as the range
of results observed. In addition, please identify the range of increases in the Nav1.1
protein that was observed in your study with monkeys and the number of monkeys
sacrificed at 3 days and at 29 days after dosing.
14.Please clarify what you mean by "non-Good Laboratory Practice" on page 103, and
disclose whether you will be able to use the results of this test as part of your IND
submission to the FDA .
Additional product opportunities, page 104
15.Please revise your disclosure on page 104 and similar statements throughout that refer to
your "broader pipeline of first-in-class medicines" as this statement and other similar
statements throughout are inappropriate given the stage of development of your product
candidate. In this regard, we note that you have identified only one product candidate,
which is still in the preclinical stage.
Intellectual property
License agreements
Cold Spring Harbor Laboratory, page 109
16.Please quantify your royalty obligations under the CSHL and Southampton
Agreements and the and the percentage of the sublicense revenue if you sublicense rights
under the CSHL Agreement.
Notes to Consolidated Financial Statements
8. Convertible preferred stock
Liquidation , page F-18
17.Considering that the company may be subject to an involuntary event, which may trigger
payment to the preferred stockholders, please provide us your analysis under ASR 268
supporting your classification of convertible preferred stock within permanent equity.
General
18.Please provide us mockups of any pages that include any additional pictures or graphics to
be presented, including any accompanying captions. Please keep in mind, in scheduling
your printing and distribution of the preliminary prospectus, that we may have comments
after our review of these materials.
FirstName LastNameEdward Kaye
Comapany NameStoke Therapeutics, Inc.
April 17, 2019 Page 5
FirstName LastName
Edward Kaye
Stoke Therapeutics, Inc.
April 17, 2019
Page 5
You may contact Rolf Sundwall at 202-551-3105 or Jim Rosenberg at 202-551-3679 if
you have questions regarding comments on the financial statements and related matters. Please
contact Sonia Bednarowski at 202-551-3666 or Justin Dobbie at 202-551-3469 with any other
questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance