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Letter Text
Wave Life Sciences, Inc.
Awaiting Response
0 company response(s)
High
Wave Life Sciences, Inc.
Response Received
2 company response(s)
High - file number match
SEC wrote to company
2019-11-27
Wave Life Sciences, Inc.
Filing - SEC Comment Letter to Wave Life Sciences, Inc.
UPLOAD · 2019-11-27
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Company responded
2019-12-03
Wave Life Sciences, Inc.
References: November 26, 2019
Filing - Correspondence from Wave Life Sciences, Inc.
CORRESP · 2019-12-03
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Company responded
2026-05-01
Wave Life Sciences, Inc.
References: April 30, 2026
Wave Life Sciences, Inc.
Awaiting Response
0 company response(s)
High
Wave Life Sciences, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2022-03-07
Wave Life Sciences, Inc.
Filing - SEC Comment Letter to Wave Life Sciences, Inc.
UPLOAD · 2022-03-07
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Company responded
2022-05-02
Wave Life Sciences, Inc.
Filing - Correspondence from Wave Life Sciences, Inc.
CORRESP · 2022-05-02
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Wave Life Sciences, Inc.
Awaiting Response
0 company response(s)
High
SEC wrote to company
2019-12-06
Wave Life Sciences, Inc.
Filing - SEC Comment Letter to Wave Life Sciences, Inc.
UPLOAD · 2019-12-06
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Wave Life Sciences, Inc.
Response Received
1 company response(s)
High - file number match
SEC wrote to company
2019-08-09
Wave Life Sciences, Inc.
Filing - SEC Comment Letter to Wave Life Sciences, Inc.
UPLOAD · 2019-08-09
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Company responded
2019-08-12
Wave Life Sciences, Inc.
Filing - Correspondence from Wave Life Sciences, Inc.
CORRESP · 2019-08-12
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Wave Life Sciences, Inc.
Response Received
1 company response(s)
Medium - date proximity
SEC wrote to company
2017-01-17
Wave Life Sciences, Inc.
Filing - SEC Comment Letter to Wave Life Sciences, Inc.
UPLOAD · 2017-01-17
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Company responded
2017-02-02
Wave Life Sciences, Inc.
Filing - Correspondence from Wave Life Sciences, Inc.
CORRESP · 2017-02-02
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Wave Life Sciences, Inc.
Response Received
3 company response(s)
Medium - date proximity
SEC wrote to company
2015-10-20
Wave Life Sciences, Inc.
Filing - SEC Comment Letter to Wave Life Sciences, Inc.
UPLOAD · 2015-10-20
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Company responded
2015-10-23
Wave Life Sciences, Inc.
References: October 2, 2015 | October 20, 2015
Filing - Correspondence from Wave Life Sciences, Inc.
CORRESP · 2015-10-23
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↓
Company responded
2015-11-06
Wave Life Sciences, Inc.
Filing - Correspondence from Wave Life Sciences, Inc.
CORRESP · 2015-11-06
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Company responded
2015-11-06
Wave Life Sciences, Inc.
Filing - Correspondence from Wave Life Sciences, Inc.
CORRESP · 2015-11-06
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Wave Life Sciences, Inc.
Awaiting Response
0 company response(s)
Medium
SEC wrote to company
2015-10-02
Wave Life Sciences, Inc.
Filing - SEC Comment Letter to Wave Life Sciences, Inc.
UPLOAD · 2015-10-02
Generating summary...
Summary
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-05-05 | SEC Comment Letter | Wave Life Sciences, Inc. | DE | 001-37627 | Read Filing View |
| 2026-05-01 | Company Response | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2026-04-30 | SEC Comment Letter | Wave Life Sciences, Inc. | DE | 001-37627 | Read Filing View |
| 2022-05-02 | Company Response | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2022-03-07 | SEC Comment Letter | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2019-12-06 | SEC Comment Letter | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2019-12-03 | Company Response | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2019-11-27 | SEC Comment Letter | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2019-08-12 | Company Response | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2019-08-09 | SEC Comment Letter | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2017-02-02 | Company Response | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2017-01-17 | SEC Comment Letter | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2015-11-06 | Company Response | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2015-11-06 | Company Response | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2015-10-23 | Company Response | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2015-10-20 | SEC Comment Letter | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2015-10-02 | SEC Comment Letter | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-05-05 | SEC Comment Letter | Wave Life Sciences, Inc. | DE | 001-37627 | Read Filing View |
| 2026-04-30 | SEC Comment Letter | Wave Life Sciences, Inc. | DE | 001-37627 | Read Filing View |
| 2022-03-07 | SEC Comment Letter | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2019-12-06 | SEC Comment Letter | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2019-11-27 | SEC Comment Letter | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2019-08-09 | SEC Comment Letter | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2017-01-17 | SEC Comment Letter | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2015-10-20 | SEC Comment Letter | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2015-10-02 | SEC Comment Letter | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| Date | Type | Company | Location | File No | Link |
|---|---|---|---|---|---|
| 2026-05-01 | Company Response | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2022-05-02 | Company Response | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2019-12-03 | Company Response | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2019-08-12 | Company Response | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2017-02-02 | Company Response | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2015-11-06 | Company Response | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2015-11-06 | Company Response | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
| 2015-10-23 | Company Response | Wave Life Sciences, Inc. | DE | N/A | Read Filing View |
2026-05-05 - UPLOAD - Wave Life Sciences, Inc. File: 001-37627
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> May 5, 2026 Paul Bolno Chief Executive Officer Wave Life Sciences Ltd. 7 Straits View #12-00 Marina One East Tower Singapore 018936 Re: Wave Life Sciences Ltd. Preliminary Proxy Statement on Schedule 14A Filed April 15, 2026 File No. 001-37627 Dear Paul Bolno: We have completed our review of your filing. We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Mark M. Bekheit, Esq. </TEXT> </DOCUMENT>
2026-05-01 - CORRESP - Wave Life Sciences, Inc.
CORRESP 1 filename1.htm CORRESP 505 Montgomery Street, Suite 2000 San Francisco, California 94111-6538 Tel: +1.415.391.0600 Fax: +1.415.395.8095 www.lw.com FIRM / AFFILIATE OFFICES Austin Milan Beijing Munich Boston New York Brussels Orange County Chicago Paris May 1, 2026 Dubai Riyadh Düsseldorf San Diego Frankfurt San Francisco Hamburg Seoul Hong Kong Silicon Valley Houston Singapore London Tel Aviv VIA EDGAR Los Angeles Tokyo Madrid Washington, D.C. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549-6010 Attention: Ms. Jessica Dickerson Mr. Chris Edwards Re: Preliminary Proxy Statement on Schedule 14A of Wave Life Sciences Ltd. Filed April 15, 2026 (File No. 001-37627) Ladies and Gentlemen: On behalf of Wave Life Sciences Ltd., a public company limited by shares incorporated under the laws of the Republic of Singapore (“ Wave ”), we submit this letter in response to the comments and requests for additional information contained in the letter (the “ Comment Letter ”) from the staff of the Division of Corporation Finance (the “ Staff ”) of the United States Securities and Exchange Commission (the “ Commission ”), dated April 30, 2026, regarding the Preliminary Proxy Statement on Schedule 14A, which was filed with the Commission on April 15, 2026 (the “ Proxy Statement ”). Wave has further revised the Proxy Statement in response to the Comment Letter and is concurrently filing via EDGAR Amendment No. 1 to the Proxy Statement (the “ Amended Proxy Statement ”) that reflects these revisions and generally updates the information contained therein. For your convenience, we have repeated each comment of the Staff in italicized text and set forth our response below each comment. All references to page numbers in the responses to the Staff’s comments correspond to the pages in the Amended Proxy Statement. All terms used but not defined in this letter have the meanings assigned to such terms in the Amended Proxy Statement. Staff Comments Description of Wave-Delaware Capital Stock; Choice of Forum, page 51 1. We note your disclosure regarding the forum selection clause in the Wave-Delaware amended and restated certificate of incorporation. Please revise your disclosure to describe any subject matter jurisdiction carve out, including to clarify whether the clause is intended to apply to federal securities law claims, and to describe any risks or other impacts on stockholders. In May 1, 2026 Page 2 describing any such risks, you should address the increased costs that stockholders may experience in bringing a claim and the potential that the forum selection clause may discourage claims or limit stockholders’ ability to bring a claim in a judicial forum that they find favorable. Please also disclose that stockholders cannot waive compliance with the federal securities laws and the rules and regulations thereunder. Response: The Company respectfully acknowledges the Staff’s comment and has revised page 51 of the Amended Proxy Statement to include such disclosure. * * * * * * Please do not hesitate to contact Mark Bekheit by telephone at (650) 463-3032 or by email at mark.bekheit@lw.com , or Lauren Lefcoe by telephone at (415) 395-8294 or by e-mail at lauren.lefcoe@lw.com , with any questions or comments regarding this correspondence. Very truly yours, /s/ Mark Bekheit Mark M. Bekheit of LATHAM & WATKINS LLP cc: Paul Bolno, Wave Life Sciences Ltd. Linda Rockett, Wave Life Sciences Ltd. Lauren Lefcoe, Latham & Watkins LLP
2026-04-30 - UPLOAD - Wave Life Sciences, Inc. File: 001-37627
<DOCUMENT> <TYPE>TEXT-EXTRACT <SEQUENCE>2 <FILENAME>filename2.txt <TEXT> April 30, 2026 Paul Bolno Chief Executive Officer Wave Life Sciences Ltd. 7 Straits View #12-00 Marina One East Tower Singapore 018936 Re: Wave Life Sciences Ltd. Preliminary Proxy Statement on Schedule 14A Filed April 15, 2026 File No. 001-37627 Dear Paul Bolno: We have reviewed your filing and have the following comment. Please respond to this letter within ten business days by providing the requested information or advise us as soon as possible when you will respond. If you do not believe a comment applies to your facts and circumstances, please tell us why in your response. After reviewing your response to this letter, we may have additional comments. Preliminary Proxy Statement on Schedule 14A Description of Wave-Delaware Capital Stock Choice of Forum, page 51 1. We note your disclosure regarding the forum selection clause in the Wave-Delaware amended and restated certificate of incorporation. Please revise your disclosure to describe any subject matter jurisdiction carve out, including to clarify whether the clause is intended to apply to federal securities law claims, and to describe any risks or other impacts on stockholders. In describing any such risks, you should address the increased costs that stockholders may experience in bringing a claim and the potential that the forum selection clause may discourage claims or limit stockholders' ability to bring a claim in a judicial forum that they find favorable. Please also disclose that stockholders cannot waive compliance with the federal securities laws and the rules and regulations thereunder. April 30, 2026 Page 2 We remind you that the company and its management are responsible for the accuracy and adequacy of their disclosures, notwithstanding any review, comments, action or absence of action by the staff. Please contact Jessica Dickerson at 202-551-8013 or Chris Edwards at 202-551-6761 with any questions. Sincerely, Division of Corporation Finance Office of Life Sciences cc: Mark M. Bekheit, Esq. </TEXT> </DOCUMENT>
2022-05-02 - CORRESP - Wave Life Sciences, Inc.
CORRESP 1 filename1.htm CORRESP WAVE LIFE SCIENCES LTD. 7 Straits View #12-00, Marina One East Tower Singapore 018936 May 2, 2022 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Tim Buchmiller RE: Wave Life Sciences Ltd. Registration Statement on Form S-3 Filed March 3, 2022 File No. 333-263251 Acceleration Request Dear Mr. Buchmiller: With respect to the above-referenced Registration Statement on Form S-3 (the “Registration Statement”), and pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, the undersigned hereby respectfully requests, on behalf of Wave Life Sciences Ltd. (the “Company”), that the Securities and Exchange Commission (the “Commission”) accelerate the effective date of the Registration Statement to Wednesday, May 4, 2022, at 4:00 p.m. Eastern Time, or as soon as practicable thereafter. The cooperation of the staff in meeting the timetable described above is very much appreciated. Please call John T. Rudy or John P. Condon of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Company, at (617) 542-6000, with any comments or questions regarding the Registration Statement. Very truly yours, WAVE LIFE SCIENCES LTD. /s/ Kyle Moran Kyle Moran Chief Financial Officer cc: Linda Rockett, Esq., Senior Vice President, General Counsel, Wave Life Sciences Ltd. John T. Rudy, Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. John P. Condon, Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2022-03-07 - UPLOAD - Wave Life Sciences, Inc.
United States securities and exchange commission logo
March 7, 2022
Linda Rockett, Esq.
Senior Vice President, General Counsel
Wave Life Sciences Ltd.
c/o 733 Concord Avenue
Cambridge, MA 02138
Re:Wave Life Sciences Ltd.
Registration Statement on Form S-3
Filed March 3, 2022
File No. 333-263251
Dear Ms. Rockett:
This is to advise you that we have not reviewed and will not review your registration
statement.
Please refer to Rules 460 and 461 regarding requests for acceleration. We remind you
that the company and its management are responsible for the accuracy and adequacy of their
disclosures, notwithstanding any review, comments, action or absence of action by the staff.
Please contact Tim Buchmiller at (202) 551-3635 with any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
cc: John P. Condon, Esq.
2019-12-06 - UPLOAD - Wave Life Sciences, Inc.
December 6, 2019
Keith Regnante
Chief Financial Officer
Wave Life Sciences Ltd.
7 Straits View #12-00
Marina One East Tower
Singapore 018936
Re:Wave Life Sciences Ltd.
Form 10-K for fiscal year ended December 31, 2018
Filed March 1, 2019
File No. 001-37627
Dear Mr. Regnante:
We have completed our review of your filing. We remind you that the company and its
management are responsible for the accuracy and adequacy of their disclosures, notwithstanding
any review, comments, action or absence of action by the staff.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2019-12-03 - CORRESP - Wave Life Sciences, Inc.
CORRESP 1 filename1.htm CORRESP CONFIDENTIAL TREATMENT REQUESTED BY WAVE LIFE SCIENCES LTD. PURSUANT TO 17 C.F.R. §200.83 December 2, 2019 Via EDGAR and Courier Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, DC 20549 Attn: Mary Mast and Frank Wyman Re: Wave Life Sciences Ltd. Form 10-K for the Fiscal Year Ended December 31, 2018 Filed March 1, 2019 File No. 001-37627 Dear Ms. Mast and Mr. Wyman: Wave Life Sciences Ltd. (the “Company” or “Wave”) is submitting this letter in response to the written comments of the staff (the “Staff”) of the Division of Corporation Finance of the Securities and Exchange Commission (the “Commission”), dated November 26, 2019 (the “Comment Letter”) with regards to the Company’s Annual Report on Form 10-K for the period ended December 31, 2018 filed with the Commission on March 1, 2019 (the “Form 10-K”). For the convenience of the Staff’s review, we have set forth the comments contained in the Comment Letter in bold and italics followed by the Company’s response. 1. Please provide us the following terms governing the Takeda collaboration, as well as your consideration of providing additional disclosure pursuant to ASC 606-10-50. • Quantify the amount allocated to each performance obligation. Background In February 2018, Wave Life Sciences USA, Inc. (“Wave USA”) and Wave Life Sciences UK Limited (“Wave UK”) entered into a global strategic collaboration (the “Takeda Collaboration Agreement”) with Takeda Pharmaceutical Company Limited (“Takeda”), pursuant to which Wave USA, Wave UK and Takeda agreed to collaborate on the research, development and commercialization of oligonucleotide therapeutics for disorders of the Central Nervous System (“CNS”). The Takeda Collaboration Agreement provides Wave with at least $230.0 million in committed cash and Takeda with the option to co-develop and co-commercialize Wave’s CNS development programs in (1) Huntington’s disease (“HD”); (2) amyotrophic lateral sclerosis (“ALS”) and frontotemporal dementia (“FTD”); and (3) Wave’s discovery-stage program targeting ATXN3 for the treatment of spinocerebellar ataxia 3 (“SCA3”) (collectively, “Category 1 Programs”), which Wave will have the right to co-commercialize in the United States. In addition, Takeda will have the right to exclusively license multiple preclinical programs for CNS disorders, including Alzheimer’s disease and Parkinson’s disease (collectively, “Category 2 Programs”). In April 2018, the Takeda Collaboration Agreement became effective and Takeda paid Wave $110.0 million as an upfront payment. Takeda also agreed to fund Wave’s research and preclinical activities in the amount of $60.0 million during the four-year research term and to reimburse Wave for any collaboration-budgeted research and preclinical expenses incurred by Wave that exceed that amount. Simultaneously with Wave USA and Wave UK’s entry into the Takeda Collaboration Agreement, the Company entered into a share purchase agreement with Takeda (the “Takeda Equity Agreement,” and together with the Takeda Collaboration Agreement, the “Takeda Agreements”) pursuant to which it agreed to sell to Takeda 1,096,892 of its ordinary shares at a purchase price of $54.70 per share. In April 2018, the Company closed the share purchase pursuant to the Takeda Equity Agreement and received aggregate cash proceeds of $60.0 million. With respect to Category 1 Programs, Wave will be responsible for researching and developing products and companion diagnostics for Category 1 Programs through completion of the first proof of mechanism study (“POM”) for such products. Takeda will have an exclusive option for each target and all associated products and companion diagnostics for such target, which it may exercise at any time through completion of POM. If Takeda exercises this option, Wave will receive an opt-in payment and will lead manufacturing and joint clinical co-development activities and Takeda will lead joint co-commercial activities in the United States and all commercial activities outside of the United States. Global costs and potential profits will be shared 50:50 and Wave will be eligible to receive development and commercial milestone payments. In addition to its 50% profit share, Wave is eligible to receive option exercise fees and development and commercial milestone payments for each of the Category 1 Programs. With respect to Category 2 Programs, Wave has granted Takeda the right to exclusively license multiple preclinical programs during a four-year research term (subject to limited extension for programs that were initiated prior to the expiration of the research term, in accordance with the Takeda Collaboration Agreement) (“Category 2 Research Term”). During that term, the parties may collaborate on preclinical programs for up to six targets at any one time. Wave will be responsible for researching and preclinically developing products and companion diagnostics directed to the agreed upon targets through completion of IND-enabling studies in the first major market country. Thereafter, Takeda will have an exclusive worldwide license to develop and commercialize products and companion diagnostics directed to such targets, subject to Wave’s retained rights to lead manufacturing activities for products [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to 17 C.F.R. §200.83. 2 directed to such targets. Takeda will fund Wave’s research and preclinical activities in the amount of $60.0 million during the research term and will reimburse Wave for any collaboration-budgeted research and preclinical expenses incurred by Wave that exceed that amount. Wave is also eligible to receive tiered high single-digit to mid-teen royalties on Takeda’s global commercial sales of products from each Category 2 Program. The Company assessed this arrangement in accordance with ASC 606-10-25-14 and identified the following under the arrangement to be considered: (1) the non-exclusive, royalty-free research and development license for each Category 1 Program; (2) the research and development services for each Category 1 Program through POM; (3) the right to exclusively license the Category 2 Programs; and (4) the research and preclinical development services of the Category 2 Programs through completion of IND-enabling studies. The research and development services for each Category 1 Program were determined not to be distinct from the research and development license and were therefore combined into a single performance obligation for each Category 1 Program. The research and preclinical development services for the Category 2 Programs were determined not to be distinct from the exclusive licenses for the Category 2 Programs and were therefore combined into a single performance obligation. Additionally, in accordance with ASC 606-10-55-42 the Company determined that the exclusive options to license, co-develop and co-commercialize each Category 1 Program were priced at a discount and, as such, provide material rights to Takeda, representing three separate performance obligations. Based on these assessments, the Company identified a total of seven performance obligations in the Takeda Collaboration Agreement: (1) research and development services through completion of POM and non-exclusive research and development license for HD; (2) research and development services through completion of POM and non-exclusive research and development license for ALS and FTD; (3) research and development services through completion of POM and non-exclusive research and development license for SCA3; (4) the material right provided for the exclusive option to license, co-develop and co-commercialize HD; (5) the material right provided for the exclusive option to license, co-develop and co-commercialize ALS and FTD; (6) the material right provided for the exclusive option to license, co-develop and co-commercialize SCA3; and (7) the research and preclinical development services and right to exclusively license the Category 2 Programs. Based on the Company’s application of ASC 606, the Company has determined that the amount of the transaction price allocated to each performance obligation is as follows: Performance Obligation Allocated Transaction Price (000’s) 1 Research and development services through completion of POM and non-exclusive research and development license for HD [***] 2 Research and development services through completion of POM and non-exclusive research and development license for ALS and FTD [***] [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to 17 C.F.R. §200.83. 3 3 Research and development services through completion of POM and non-exclusive research and development license for SCA3 [***] 4 The material right provided for the exclusive option to license, co-develop and co-commercialize HD [***] 5 The material right provided for the exclusive option to license, co-develop and co-commercialize ALS and FTD [***] 6 The material right provided for the exclusive option to license, co-develop and co-commercialize SCA3 [***] 7 The research and preclinical development services and right to exclusively license the Category 2 Programs [***] TOTAL $ 170,000 Page F-18 of the Form 10-K states that, “The aggregate amount of the transaction price allocated to the Company’s unsatisfied and partially unsatisfied performance obligations and recorded in deferred revenue at December 31, 2018 is $160.4 million, of which $94.1 million is included in current liabilities.” The Company believes that this disclosure addresses the requirements of ASC 606-10-50-13, and believes that more disaggregated disclosure regarding allocation of the transaction price to individual performance obligations is neither material nor useful to investors. • Describe and quantify the methods and assumptions used to determine standalone selling price for each collaboration. Per ASC 606-10-32-28, the objective when allocating the transaction price is for an entity to allocate the transaction price to each performance obligation (or distinct good or service) in an amount that depicts the amount of consideration to which the entity expects to be entitled in exchange for transferring the promised goods or services to the customer. Per ASC 606-10-32-29, to meet the allocation objective, an entity shall allocate the transaction price to each performance obligation identified in the contract on a relative standalone selling price basis in accordance with paragraphs 606-10-32-31 through 32-35, except as specified in paragraphs 606-10-32-36 through 32-38 (for allocating discounts) and paragraphs 606-10-32-39 through 32-41 (for allocating consideration that includes variable amounts). Per ASC 606-10-32-31, to allocate the transaction price to each performance obligation on a relative standalone selling price basis, an entity shall determine the standalone selling price at contract inception of the distinct good or service underlying each performance obligation in the contract and allocate the transaction price in proportion to those standalone selling prices. Per ASC 606-10-32-33, if a standalone selling price is not directly observable, an entity shall estimate the standalone selling price at an amount that would result in the allocation of the transaction price meeting the allocation objective in paragraph 606-10-32-28. When estimating a [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to 17 C.F.R. §200.83. 4 standalone selling price, an entity shall consider all information (including market conditions, entity-specific factors, and information about the customer or class of customer) that is reasonably available to the entity. In doing so, an entity shall maximize the use of observable inputs and apply estimation methods consistently in similar circumstances. Performance Obligations 1, 2 and 3 In order to estimate the standalone selling price for performance obligations 1, 2 and 3 above, the Company considered ASC 606-10-32-34 and utilized a cost plus margin approach. The Company forecasted the expected costs to be incurred from contract inception through the estimated potential option exercise date for each Category 1 Program plus an estimated profit margin. Performance Obligations 4, 5 and 6 In order to estimate the standalone selling price for performance obligations 4, 5 and 6 above, the Company considered ASC 606-10-32-34 and utilized an adjusted market assessment approach. The Company estimated the value of each Category 1 Option by performing a discounted cash flow analysis (“DCF”) as of the estimated potential option exercise date for each Category 1 Program. The estimated free cash flow for each Category 1 Program was reduced by 50% to reflect the 50:50 co-development / co-commercialization post option exercise, and then further adjusted for the estimated probability of reaching the commercial stage from the estimated potential option exercise date. Assumptions in the DCF for each Category 1 Program included patient population, annual cost of therapy (pricing), and the discount rate, among others. The net present value of the DCF for each Category 1 Target was compared to the payments that Takeda would be required to make before achieving the commercial stage for each Category 1 Program (option fee plus the net present value (as of estimated potential option exercise date) of any development milestones to be paid). As the net present value of each DCF exceeded Takeda’s required payments for each such Category 1 Program, the excess amount was reduced by the probability of achieving POM. The resulting probability-adjusted discount was considered a material right and was determined to be the estimated standalone selling price for each performance obligation 4, 5 and 6. Performance Obligation 7 In order to estimate the standalone selling price for performance obligation 7, the Company considered ASC 606-10-32-34 and utilized a cost plus margin approach. The Company estimated the value of the Category 2 services by totaling (1) the $60 million minimum funding, and (2) the estimated costs incurred by the Company for the Company’s CNS programs subject to potential nomination under Category 2 as of the contract inception date plus an estimated profit margin. [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to 17 C.F.R. §200.83. 5 In future filings with the Commission beginning with the Company’s Annual Report on Form 10-K for the period ended December 31, 2019, the Company agrees to revise its disclosure to describe the methods and assumptions used to determine the standalone selling price for each performance obligation in accordance with ASC 606-10-50-20(c) by adding the following to its Collaboration Agreements footnote: Proposed New Disclosure: “The Company allocated the transaction price to the performance obligations on a relative standalone selling price basis. For the performance obligations associated with the research and development services through completion of the first proof of mechanism and non-exclusive research and development license for HD; the research and development services through completion of the first proof of mechanism and non-exclusive research and development license for ALS and FTD; the research and development services through completion of the
2019-11-27 - UPLOAD - Wave Life Sciences, Inc.
November 26, 2019
Keith Regnante
Chief Financial Officer
Wave Life Sciences Ltd.
7 Straits View #12-00
Marina One East Tower
Singapore 018936
Re:Wave Life Sciences Ltd.
Form 10-K for fiscal year ended December 31, 2018
Filed March 1, 2019
File No. 001-37627
Dear Mr. Regnante:
We have limited our review of your filing to the financial statements and related
disclosures 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 these comments within ten business days by providing the requested
information or advise us as soon as possible when you will respond. If you do not believe 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.
Form 10-K for fiscal year ended December 31, 2018
Notes to Consolidated Financial Statements
Note 5, Collaboration Agreements, page F-15
1.Please provide us the following terms governing the Takeda collaboration, as well as your
consideration of providing additional disclosure pursuant to ASC 606-10-50.
•Quantify the amount allocated to each performance obligation.
•Describe and quantify the methods and assumptions used to determine standalone
selling price for each collaboration.
•Provide a range of milestone and other payment obligations to be received by stage
(e.g. development, regulatory and commercialization). Also, tell us your
consideration of disclosing individually material milestones.
•It appears that the amount paid by Takeda for the purchase of 1,096,892 shares
included a premium over the fair value of your stock on the date of purchase. Clarify
FirstName LastNameKeith Regnante
Comapany NameWave Life Sciences Ltd.
November 26, 2019 Page 2
FirstName LastName
Keith Regnante
Wave Life Sciences Ltd.
November 26, 2019
Page 2
how you accounted for the premium.
2.Please provide us the following information regarding licenses that you received under
your collaboration agreements with Pfizer and Takeda and your consideration of
providing additional disclosure under ASC 606.
•Provide a range of future milestone obligations by stage that you may be required to
pay to Pfizer and Takeda (e.g. development, regulatory and commercialization).
•Tell us your consideration of including disclosure relating to your obligations on page
95 under the Contractual Obligation Table.
•Provide a description and quantification of other possible future obligations that you
may be required to pay under these two collaboration agreements.
•Explain your basis for excluding discussion of governance by a joint steering
committee, as described in the Takeda collaboration agreement. Also, tell us your
consideration of including your obligations under the joint steering committee as a
separate performance obligation.
3.You state on page F-18 that at December 31, 2018, deferred revenue under the Takeda
agreement was $160.4 million, of which $94.1 million was included in current liabilities.
At September 30, 2019, deferred revenue under this agreement was $152.8 million, of
which $93.6 million was included in current liabilities, while revenue recognized for the
nine months ended September 30, 2019 was $17.2 million. Please demonstrate for us how
revenue recognized was consistent with the expected research term governing each
performance obligation, including how associated incurred FTE hours compared to total
expected FTE hours. Also, provide us additional information for each collaboration that
will facilitate an understanding of the nature, timing and uncertainty of revenue
recognized to date and to be recognized in future periods.
In closing, 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.
You may contact Frank Wyman at 202-551-3660 or Mary Mast at 202-551-3613 with
any questions.
Sincerely,
Division of Corporation Finance
Office of Life Sciences
2019-08-12 - CORRESP - Wave Life Sciences, Inc.
CORRESP 1 filename1.htm CORRESP WAVE LIFE SCIENCES LTD. 7 Straits View #12-00, Marina One East Tower Singapore 018936 August 12, 2019 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attn: Tonya K. Aldave RE: Wave Life Sciences Ltd. Registration Statement on Form S-3 Filed August 6, 2019 File No. 333-233052 Acceleration Request Dear Ms. Aldave: With respect to the above-referenced Registration Statement on Form S-3 (the “Registration Statement”), and pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, the undersigned hereby respectfully requests, on behalf of Wave Life Sciences Ltd. (the “Company”), that the Securities and Exchange Commission (the “Commission”) accelerate the effective date of the Registration Statement to Wednesday, August 14, 2019, at 4:00 p.m. Eastern Time, or as soon as practicable thereafter. The cooperation of the staff in meeting the timetable described above is very much appreciated. Please call John T. Rudy or John P. Condon of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Company, at (617) 542-6000, with any comments or questions regarding the Registration Statement. Very truly yours, WAVE LIFE SCIENCES LTD. /s/ Keith C. Regnante Keith C. Regnante Chief Financial Officer cc: Linda Rockett, Esq., Senior Vice President, General Counsel, Wave Life Sciences Ltd. John T. Rudy, Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. John P. Condon, Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2019-08-09 - UPLOAD - Wave Life Sciences, Inc.
August 9, 2019
Paul Bolno
Chief Executive Officer
Wave Life Sciences Ltd.
7 Straits View #12-00, Marina One East Tower
Singapore 018936
Re:Wave Life Sciences Ltd.
Registration Statement on Form S-3
Filed August 6, 2019
File No. 333-233052
Dear Dr. Bolno:
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 Tonya K. Aldave at (202) 551-3601 with any questions.
Sincerely,
Division of Corporation Finance
Office of Healthcare & Insurance
cc: John Condon, Esq.
2017-02-02 - CORRESP - Wave Life Sciences, Inc.
CORRESP 1 filename1.htm CORRESP WAVE LIFE SCIENCES LTD. 8 Cross Street #10-00, PWC Building Singapore 048424 February 2, 2017 VIA EDGAR United States Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 RE: WAVE Life Sciences Ltd. Registration Statement on Form S-3, as amended File No. 333-215428 Acceleration Request Ladies and Gentlemen: With respect to the above-referenced Registration Statement on Form S-3, as amended (the “Registration Statement”), and pursuant to Rule 461 of Regulation C promulgated under the Securities Act of 1933, as amended, the undersigned hereby respectfully requests, on behalf of WAVE Life Sciences Ltd. (the “Company”), that the Securities and Exchange Commission (the “Commission”) accelerate the effective date of the Registration Statement to Monday, February 6, 2017, at 4:00 p.m. Eastern Time, or as soon as practicable thereafter. The cooperation of the staff in meeting the timetable described above is very much appreciated. Please call Brian Keane or John Condon of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Company, at (617) 542-6000, with any comments or questions regarding the Registration Statement. Very truly yours, WAVE LIFE SCIENCES LTD. /s/ Keith Regnante Keith Regnante Chief Financial Officer cc: Josh Samples, Securities and Exchange Commission Joseph McCann, Securities and Exchange Commission Linda Rockett, Esq., General Counsel, Wave Life Sciences Ltd. Brian P. Keane, Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. John P. Condon, Esq., Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
2017-01-17 - UPLOAD - Wave Life Sciences, Inc.
January 17, 2017
Paul B. Bolno
President and Chief Executive Officer
WAVE Life Sciences Ltd.
8 Cross Street #10-00
PWC Building
Singapore 048424
WAVE Life Sciences Ltd.
Registration Statement on Form S-3
Filed January 4, 2017
File No. 333-215428Re:
Dear Dr. Bolno:
We have limited our review of your registration statement to those issues we have
addressed in our comments. In some of our comments, we may ask you to provide us with
information so we may better understand your disclosure.
Please respond to this letter by amending your registration statement and providing the
requested information. If you do not believe our comments apply to your facts and circumstances
or do not believe an amendment is appropriate, please tell us why in your response.
After reviewing any amendment to your registration statement and the information you
provide in response to these comments, we may have additional comments.
Form S-3 filed January 4, 2017
Exhibits
We note that you are registering rights under the registration statement. Please have
counsel revise the legality opinion to cover these rights. For guidance, please see Part
II.B.1.f of Staff Legal Bulletin No. 19.1.
We note that the debt securities are governed by New York law but that counsel's legality
opinion is limited to Singapore law. As such, please file an opinion pursuant to
Regulation S-K, Item 601(b)(5) that covers the legality of the debt securities under New
York law. For guidance, please refer to Staff Legal Bulletin No. 19, Part II.B.1.e and Part
II.B.3.b.2.
Paul B. Bolno
WAVE Life Sciences Ltd.
2 PageJanuary 17, 2017
We remind you that the company and its management are responsible for the accuracy and
adequacy of their disclosures, notwithstanding any review, comments, action or absence of action
by the staff.
Refer to Rules 460 and 461 regarding requests for acceleration. Please allow adequate
time for us to review any amendment prior to the requested effective date of the registration
statement.
Please contact Josh Samples at (202) 551-3199 or Joseph McCann at (202) 551-6262 with any
questions.
Division of Corporation Finance
Office of Healthcare and
Insurance
cc: Brian Keane, Esq.
2015-11-06 - CORRESP - Wave Life Sciences, Inc.
CORRESP 1 filename1.htm Company Acceleration Request WAVE Life Sciences Ltd. 8 Cross Street #10-00 PWC Building Singapore 048424 November 6, 2015 VIA EDGAR U.S. Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Suzanne Hayes, Assistant Director Christina De Rosa Christian Windsor Lisa Vanjoske Joel Parker Re: WAVE Life Sciences Ltd. Registration Statement on Form S-1 File No. 333-207379 Acceleration Request Requested Date: November 10, 2015 Requested Time: 4:00 p.m. Eastern Standard Time Ladies and Gentlemen: In accordance with Rule 461 under the Securities Act of 1933, as amended, WAVE Life Sciences Ltd. (the “Registrant”) hereby requests that the U.S. Securities and Exchange Commission (the “Commission”) take appropriate action to cause the above-referenced Registration Statement to become effective on November 10, 2015, at 4:00 p.m. Eastern Standard Time, or as soon as practicable thereafter, or at such later time as the Registrant may orally request via telephone call to the staff of the Commission (the “Staff”). The Registrant hereby authorizes each of Matthew J. Gardella and Matthew W. Tikonoff of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Registrant, to make such request on its behalf. In connection with this request, the Registrant acknowledges that: • should the Commission or the Staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission from taking any action with respect to the filing; • the action of the Commission or the Staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the Registrant from its full responsibility for the adequacy and accuracy of the disclosure in the filing; and • the Registrant may not assert Staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please contact Matthew J. Gardella of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., counsel to the Registrant, at (617) 348-1735 with any questions regarding this request. Very truly yours, WAVE Life Sciences Ltd. By: /s/ Paul B. Bolno, M.D. Name: Paul B. Bolno, M.D. Title: President and Chief Executive Officer cc: Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. Matthew J. Gardella William C. Hicks Matthew W. Tikonoff Cooley LLP Frank F. Rahmani Nicole Brookshire John T. McKenna
2015-11-06 - CORRESP - Wave Life Sciences, Inc.
CORRESP
1
filename1.htm
UW Acceleration Request
November 6, 2015
U.S. Securities and Exchange Commission
Division of Corporation
Finance
100 F Street, N.E.
Washington, DC 20549
Re:
WAVE Life Sciences Ltd.
Registration Statement on Form S-1 (File
No. 333-207379)
Ladies and Gentlemen:
As
representatives of the several underwriters of WAVE Life Sciences Ltd.’s proposed initial public offering, we hereby join in the request of the registrant that the effectiveness of the above-referenced Registration Statement, as amended, be
accelerated to 4:00 p.m. Eastern Standard Time, on November 10, 2015, or as soon thereafter as practicable.
In connection with the above-captioned
Registration Statement, and pursuant to Rule 460 under the Securities Act of 1933, as amended, please be advised that between November 2, 2015 and the date hereof, approximately 1,168 copies of the Preliminary Prospectus, dated November 2,
2015, were distributed to prospective underwriters, institutional investors and prospective dealers.
We have been informed by the participating
underwriters that they have complied, and will continue to comply, with the requirements of Rule 15c2-8 under the Securities Exchange Act of 1934, as amended.
[signature page follows]
Very truly yours,
Jefferies LLC
Leerink Partners LLC
As Representatives of the several Underwriters
By:
Jefferies LLC
By:
/s/ Kevin J. Sheridan
Name:
Kevin J. Sheridan
Title:
Managing Director
By:
Leerink Partners LLC
By:
/s/ Jon Civitarese
Name:
Jon Civitarese
Title:
Managing Director
[Signature Page to WAVE Life Sciences Ltd. Acceleration Request]
2015-10-23 - CORRESP - Wave Life Sciences, Inc.
CORRESP 1 filename1.htm CORRESP One Financial Center Boston, MA 02111 617-542-6000 617-542-2241 fax www.mintz.com Matthew J. Gardella | 617 348 1735 | mgardella@mintz.com CERTAIN PORTIONS OF THIS LETTER AS FILED VIA EDGAR HAVE BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED FOR THE OMITTED PORTIONS, WHICH HAVE BEEN REPLACED WITH THE PLACEHOLDER “[***].” October 23, 2015 VIA EDGAR Securities and Exchange Commission Division of Corporation Finance 100 F Street, N.E. Washington, D.C. 20549 Attention: Suzanne Hayes, Assistant Director Christina De Rosa Christian Windsor Lisa Vanjoske Joel Parker Re: Wave Life Sciences Pte. Ltd. Registration Statement on Form S-1 (File No. 333-207379) Dear Ladies and Gentlemen: We are submitting this letter on behalf of Wave Life Sciences Pte. Ltd. (the “Company”) in response to comments received from the staff (the “Staff”) of the Securities and Exchange Commission (the “Commission”) by letter dated October 2, 2015 (the “Comment Letter”) relating to the Staff’s review of the Company’s registration statement on Form S-1 submitted confidentially to the Commission on September 4, 2015, which was subsequently amended in response to the Comment Letter and filed publicly with the Commission on October 9, 2015 (the “Registration Statement”). In this letter, we are responding only to comment number 6 in the Comment Letter, the text of which we have incorporated into this response letter for convenience. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. BOSTON | LONDON | LOS ANGELES | NEW YORK | SAN DIEGO | SAN FRANCISCO | STAMFORD | WASHINGTON FOIA CONFIDENTIAL TREATMENT REQUESTED PURSUANT TO 17 C.F.R. § 200.83 BY WAVE LIFE SCIENCES PTE. LTD. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. October 23, 2015 Page 2 As an overview, the Company is filing today Amendment No. 1 to the Registration Statement in response to the Staff’s second comment letter dated October 20, 2015. Subject to resolving any outstanding Staff comments and market conditions, the Company would like to (i) prepare over the weekend of October 31 to November 1, 2015 a preliminary prospectus reflecting the Share Split based on the bona fide price range for the Company’s initial public offering (“IPO”), which the Company and its investment bankers have determined, each as discussed further below, (ii) file Amendment No. 2 with the Commission, which will include this bona fide IPO price range and reflect the Share Split, on Monday, November 2, 2015 and (iii) complete printing of the preliminary prospectus and commence a road show later that same day. Subject to market conditions, the Company’s goal would be to obtain the effectiveness of the Registration Statement and price the offering by no later than November 12, 2015, the date after which financial statements for the period ended June 30, 2015 would be stale. Accordingly, the purpose of this letter is to preview with the Staff this bona fide IPO range and the Company’s analysis of how that range compares to the valuations the Company has used (or will use), for financial reporting purposes, for equity grants in March, July and October 2015. Because the Registration Statement contains financial statements no later than June 30, 2015, the only grants presented therein for financial reporting purposes are the March grants; the presentation of the July and October 2015 equity grants would appear in the financial statements for subsequent periods (i.e., the third quarter ended September 30, 2015 and the fourth quarter ending December 31, 2015). Confidential Treatment Request Due to the commercially sensitive nature of information contained herein, the Company hereby requests, pursuant to 17 C.F.R. § 200.83, that certain portions of this letter be maintained in confidence, not be made part of any public record and not be disclosed to any person as they contain confidential information. The Company has filed a separate copy of this letter, marked to show the portions redacted from the version filed via EDGAR and for which the Company is requesting confidential treatment. In accordance with 17 C.F.R. § 200.83(d)(1), if any person (including any governmental employee who is not an employee of the Commission) should request access to or an opportunity to inspect this letter, we request that we be immediately notified of any such request, be furnished with a copy of all written materials pertaining to such request (including, but not limited to, the request itself) and be given at least ten business days advance notice of any intended release so that the Company may, if deemed necessary or appropriate, pursue any remedies available to it. In such an event, we request that you telephone the undersigned rather than rely upon the U.S. mail for such notice. The address and telephone number for Matthew Gardella, the responsible representative, is c/o Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C., One Financial Center, Boston, MA 02111, telephone number (617) 542-6000. FOIA CONFIDENTIAL TREATMENT REQUESTED PURSUANT TO 17 C.F.R. § 200.83 BY WAVE LIFE SCIENCES PTE. LTD. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. October 23, 2015 Page 3 Comment from the Staff: Management’s Discussion and Analysis of Financial Condition and Results of Operations Critical Accounting Policies and Significant Judgments and Estimates Share-Based Compensation, page 66 6. We may have additional comments on your accounting for equity issuances including stock compensation and beneficial conversion features. Once you have an estimated offering price, please provide us an analysis explaining the reasons for the differences between recent valuations of your common stock leading up to the IPO and the estimated offering price. Response: The Company supplementally advises the Staff that on October 23, 2015, representatives of the lead book-running managers of its IPO advised the Company that, based on then-current market conditions, they anticipated that the underwriters currently anticipate recommending to the Company a preliminary estimated IPO price range of $[***] to $[***] per share (the “Preliminary IPO Price Range”). The share numbers, as well as all option exercise prices and estimated fair values of ordinary shares referred to in this letter, have been adjusted to reflect an estimated 4.683373-to-1.0 share split of the Company’s capital shares (the “Share Split”), which the Company plans to reflect in a subsequent pre-effective amendment to the Registration Statement. The Preliminary IPO Price Range and the related Share Split are based on existing conditions in the public capital markets for biotechnology companies, the Company’s financial position and prospects (assuming the completion of the IPO), the market valuations of comparable publicly traded companies and preliminary discussions with the underwriters regarding potential valuations for the Company. Until such time as the Company revises the Registration Statement through a pre-effective amendment to include the price range and other details of the IPO and to commence the road show, the Preliminary IPO Price Range and the Share Split remain subject to adjustment based on factors outside the Company’s control, such as changes in market conditions, the Company’s business and prospects and the valuation of comparable publicly traded companies. Historically, the fair value of the ordinary shares underlying the Company’s share-based awards has been determined on each grant date by the Company’s board of directors (the “Board”), with input from management. All options to purchase the Company’s ordinary shares were intended to be granted with an exercise price per share no less than the fair market value per share of the FOIA CONFIDENTIAL TREATMENT REQUESTED PURSUANT TO 17 C.F.R. § 200.83 BY WAVE LIFE SCIENCES PTE. LTD. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. October 23, 2015 Page 4 Company’s ordinary shares underlying those options on the date of grant, as determined by the Board in good faith and based on the information known to the Board on the date of grant. In the absence of a public trading market for the Company’s ordinary shares, on each grant date, the Board considered various objective and subjective factors described in detail in the Registration Statement to determine fair value, including contemporaneous valuations from third-party valuation specialists using methodologies, approaches and assumptions consistent with the guidelines outlined in the American Institute of Certified Public Accountants Practice Aid, Valuation of Privately-Held-Company Equity Securities Issued as Compensation (the “Practice Aid”). In connection with its preparation for the IPO, the Company completed retrospective valuations for March 2015 and June 2015, using methodologies, approaches and assumptions consistent with the Practice Aid. The following table summarizes share awards granted since January 1, 2015, giving effect to the Share Split. Date of Grant Number of Instruments Granted (#) Per Share Exercise Price ($) Fair Value Per Share of Ordinary Shares ($) Type of Valuation Methodology 3/10/15 1,997,220 2.14 3.81 Retrospective 3/10/15 221,163 N/A (1) 3.81 Retrospective 3/22/15 140,501 2.14 3.81 Retrospective 7/9/15 114,274 5.17 7.59 Retrospective 10/7/15 82,662 8.82 8.82 Contemporaneous (1) Not applicable since the award was for fully vested ordinary shares. A discussion of each valuation and related award is as follows: March 2015 Awards On March 10, 2015 and March 22, 2015, the Board granted options to purchase an aggregate of 1,997,220 and 140,501 ordinary shares, respectively. Additionally, on March 10, 2015, the Board granted 221,163 fully vested ordinary shares to an executive of the Company. FOIA CONFIDENTIAL TREATMENT REQUESTED PURSUANT TO 17 C.F.R. § 200.83 BY WAVE LIFE SCIENCES PTE. LTD. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. October 23, 2015 Page 5 March 2015 Retrospective Valuation In accordance with the Practice Aid, the March 10, 2015 valuation used the Market Approach to determine an enterprise value. The valuation then used the Probability-Weighted Expected Return Method (“PWERM”) to allocate and value the ordinary shares. The valuation utilized the market data from recent IPOs of companies in the biopharmaceutical industry to determine the enterprise value under a short-term and long-term IPO scenario. • Under the short-term IPO scenario, the Company estimated it would be approximately 0.8 years until this transaction. The Company selected an enterprise value between the 50th and 75th percentiles of comparable public biopharmaceutical transactions. The Company discounted this scenario with a 30.0% discount rate which was based on the Venture Capital Rate of Return Studies and also applied a 7.5% Discount for Lack of Marketability (“DLOM”) under this scenario. • In the longer-term IPO scenario, the Company estimated it would be approximately 1.5 years until this transaction. The selected enterprise value was between the 50th and 75th percentile of the comparable public biopharmaceutical transactions. The Company also used a 30.0% discount rate in this scenario and applied a DLOM of 10.0% to the concluded value under this scenario. The valuation also utilized market data from recent guideline M&A transactions in the biopharmaceutical industry to determine the enterprise value under a liquidity event through a trade sale/merger transaction (high M&A) and sale of the Company’s intellectual property if neither a success sale/merger or an IPO materializes (low M&A). • Under the high M&A scenario, the Company selected an enterprise value between the 50th percentile and 75th percentile for a sale. The Company selected a term of 2.0 years as an opportune timeframe for an M&A transaction to occur, utilized a 30.0% discount rate and applied a DLOM of 15.0%. • Under the low M&A scenario, the Company selected an enterprise value just below the 25th percentile range for the low M&A scenario. The Company selected a term of 1.3 years, utilized a 30.0% discount rate and applied a DLOM of 15.0%. FOIA CONFIDENTIAL TREATMENT REQUESTED PURSUANT TO 17 C.F.R. § 200.83 BY WAVE LIFE SCIENCES PTE. LTD. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. October 23, 2015 Page 6 To determine the ordinary share value under the PWERM, the Company assigned the following probabilities to each scenario: Short-term IPO 20.0 % Long-term IPO 10.0 High M&A 55.0 Low M&A 15.0 Total 100.0 % The resulting fair value of the Company’s ordinary shares was $3.81 per share, which the Company utilized for determining the fair value per share for the March 2015 option grants. July 9, 2015 Awards On July 9, 2015, the Board granted options to purchase an aggregate of 114,274 ordinary shares with an exercise price of $5.17 per share. June 2015 Retrospective Valuation In accordance with the Practice Aid, the June 24, 2015 valuation used the Market Approach to determine an enterprise value. The valuation then used the PWERM to allocate and value the ordinary shares. The valuation utilized market data from recent IPOs of companies in the biopharmaceutical industry to determine the enterprise value under a short term and long term IPO scenario. • Under the short-term IPO scenario, the Company estimated it would be approximately 0.5 years until this transaction. The Company selected an enterprise value between the 50th and 75th percentiles of comparable public biopharmaceutical transactions. The Company discounted this scenario with a 25.0% discount rate which was based on the Venture Capital Rate of Return Studies and also applied a 5.0% DLOM under this scenario. • In the longer-term IPO scenario, the Company estimated it would be approximately 1.3 years until this transaction. The Company selected an enterprise value between the 50th and 75th percentiles of comparable public biopharmaceutical transactions. The Company also used a 25.0% discount rate in this scenario and applied a DLOM of 7.5% to the concluded value under this scenario. FOIA CONFIDENTIAL TREATMENT REQUESTED PURSUANT TO 17 C.F.R. § 200.83 BY WAVE LIFE SCIENCES PTE. LTD. Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. October 23, 2015 Page 7 The valuation utilized market data from recent guideline M&A transactions in the biopharmaceutical industry to determine the enterprise value under a high and low M&A scenario. • Under the high M&A scenario, the Company selected an enterprise value between the 50th percentile and 75th percentile for a sale. The Company selected a term of 1.8 years as an opportune timeframe for an M&A transaction to occur, utilized a 25.0% discount rate and applied a DLOM of 15.0%. • Under the low M&A scenario, the Company selected an enterprise value just below the 25th percentile range for the low M&A scenario. The Company selected a term of 1.0 years, utilized a 25.0% discount rate and applied a DLOM of 15.0%. To determine the ordinary share value under the PWERM, the Company assigned the following probabilities to each scenario: Short-term IPO 40.0 % Long-term IPO 15.0 High M&A 35.0 Low M&A 10.0 Total 100.0 % The resulting fair value of the Company’s ordinary shares was $7.59 per share, which the Company utilized for determining the fair value per share for the June 2015 option grants. The preparation of the valuation included consideration of the following factors: Company Specific During the period from March 2015 through June 2015, the Company achieved the following milestones: • The Company expanded the breath of the target platform and further developed the proof of concept across multiple modalities, including but not limited to Huntington
2015-10-20 - UPLOAD - Wave Life Sciences, Inc.
Mail Stop 4720 October 20, 2015 Via E -mail Paul B. Bolno, M.D. President and Chief Executive Officer WAVE Life Sciences Pte. Ltd. 8 Cross Street #10 -00 PWC Building Singapore 048424 Re: WAVE Life Sciences Pte. Ltd. Registration Statement on Form S -1 Filed October 9, 2015 File No. 333 -207379 Dear Dr. Bolno: 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 com ments. Prospectus Summary, page 1 1. Revise your disclosure in the Overview section to clarify that while your nucl eic acid therapeutics have led to some significant initial results, the FDA has only approved two treatments using this type of therapeutics. 2. Revise your disclosure throughout the document, and particularly in the Summary, to clarify that while you have done some initial research that suggests that by controlling stereochemistry you are able to increase the safety and effectiveness of nucleic therapy, these results are preclinical and therefore the ability of the concept to lead to therapies that can be approved for use in humans is speculative at this point. Similarly, when referencing your “demonstrated ability” to synthesize stereopure PS -modified nucleic Paul B. Bolno, M.D. WAVE Life Sciences Pte. Ltd. October 2 0, 2015 Page 2 acid therapeutics, please clarify that you have shown, in preclinical models, that your therapeutics may be able to produce complex nucleic acid therapeutic drug mixtures, if the preclinical results continue as you advance through the clini cal trials process. 3. We note your response to our prior comments 7, 9 and 10 as well as the “Glossary of Scientific Terms” added to the registration statement. In order for investors to better understand the scientific basis for your research and product targets, please revise your disclosure in the Summary, and particularly when you first introduce a scientific concept or a disease target, to provide an explanation of the scientific concept that is accessible for a reader who may lack scientific tra ining. For instance , on page 1 you discuss how your most advanced therapeutic programs target HTT SNP -1, Exon 51 and SMA D7, among other targets. Revise to explain why those specific targets are most likely to be impacted by the therapy and how the therapy woul d lead to an alleviation of the symptoms for Huntington ’s disease, DMD or IBD. Please refer to Item 503 of Regulation S -K that the prospectus summary be written in plain English. Business , page 72 Advantages of Our Approach, page 74 4. We note your disclosure, both here and on page 5 of the Summary, that you have significant experience producing PS -modified therapeutics. However, your disclosure on page 88 indicates that you have manufactured “only limited supplies” of drug substances. Since you ci te your experience producing PS -modified therapeutics, please revise the text to discuss the source of your manufact uring experience, including production beyond what you reference on page 88. If you are relying on the prior experience of your key employe es manufacturing therapeutics earlier in their career, please make this clear. Our Pipeline, page 80 5. Please revise your pipeline table to delete the list of early -stage discovery programs. Since you have not yet selected a target for the programs, it is premature to include them in a product pipeline table. If you feel that your investors would benefit from knowing other areas where you are conducting early -stage research, consider presenting them separately from your disclosure about programs where you have selected a target. Description of Share Capital, page 115 6. Please expand your discussion of your shareholder register to make clear how shares purchased in this offering are expected to be held and describe the procedures and timing required to make appropriate entries. Please include a statement, if true, that the company will perform the procedures to register the shares in the register. You should also discuss the ability of shareholders to seek rectification of the register as necessary. Paul B. Bolno, M.D. WAVE Life Sciences Pte. Ltd. October 2 0, 2015 Page 3 We ur ge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 1933 and all applicable Securities Act rules require. Since the company and its m anagement are in possession of all facts relating to a company’s disclosure, they are responsible for the accuracy and adequacy of the disclosures they have made. Notwithstanding our comments, in the event you request acceleration of the effective date of the pending registration statement, please provide a written statement from the company acknowledging that: should the Commission or the staff, acting pursuant to delegated authority, declare the filing effective, it does not foreclose the Commission f rom taking any action with respect to the filing; the action of the Commission or the staff, acting pursuant to delegated authority, in declaring the filing effective, does not relieve the company from its full responsibility for the adequacy and accurac y of the disclosure in the filing; and the company may not assert staff comments and the declaration of effectiveness as a defense in any proceeding initiated by the Commission or any person under the federal securities laws of the United States. Please refer to Rules 460 and 461 regarding requests for acceleration. We will consider a written request for acceleration of the effective date of the registration statement as confirmation of the fact that those requesting acceleration are aware of thei r respective responsibilities under the Securities Act of 1933 and the Securities Exchange Act of 1934 as they relate to the proposed public offering of the securities specified in the above registration statement. Please allow adequate time for us to rev iew any amendment prior to the requested effective date of the registration statement. Please contact Christina De Rosa at (202) 551 -3577, or Christian Windsor, Special Counsel, at (202) 551 -3419 with any questions. Sincerely, /s/ Suzanne Hayes Suzanne Hayes Assistant Director Office of Healthcare & Insurance cc: Via E -mail Matthew J. Gardella Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. Paul B. Bolno, M.D. WAVE Life Sciences Pte. Ltd. October 2 0, 2015 Page 4 One Financial Center Boston, MA 02111
2015-10-02 - UPLOAD - Wave Life Sciences, Inc.
Mail Stop 4720 October 2, 2015 Via E -mail Paul B. Bolno, M.D. President and Chief Executive Officer WAVE Life Sciences Pte. Ltd. 8 Cross Street #10 -00 PWC Building Singapore 048424 Re: WAVE Life Sciences Pte. Ltd. Draft Registration Statement on Form S -1 Submitted September 4, 2015 CIK No. 0001631574 Dear Dr. Bolno : 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 registrat ion 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 commen ts and your amended draft registration statement or filed registration statement, we may have additional comments. Prospectus Summary , page 1 Advantages of Our Approach, page 4 1. We note your statement that you “are a leader in the manufacturing of PS -modified stereopure nucleic acid therapeutics…” As you do not manufacture any commercial products, this statement appears to be premature. Please qualify the quoted language appropriately. Paul B. Bolno, M.D. WAVE Life Sciences Pte. Ltd. October 2, 2015 Page 2 Our Strategy, page 5 2. Revise the first bullet point to clarify that you must first identify product candidates and then advance those candidates through the testing and approval process. You should also clarify that your company does not have experience conducting clinical trials or otherwise advancing product candid ates through the approval process. Our Product Pipeline, page 5 3. Revise the heading to this section to more clearly indicate that you do not, at this time, have any products, but instead you have areas of research focuses which may lead to the identific ation of product candidates. Risks Related to Our Business, page 7 4. Revise this section to clarify that not only do you have a history of losses, but you have not, to date, produced meaningful revenues. Use of Proceeds, page 47 5. For each therapeutic program that you intend to develop with the proceeds from this offering, please state the anticipated stage of development that you expect to reach using the proceeds of the offering. Management’s Discussion and Analysis of Financial Cond ition and Results of Operations Critical Accounting Policies and Significant Judgments and Estimates Share -Based Compensation, page 66 6. We may have additional comments on your accounting for equity issuances including stock compensation and beneficial conversion features. Once you have an estimated offering price, please provide us an analysis explaining the reasons for the differences between recent valuations of your common stock leading up to the IPO and the estimated offering price. Business, page 71 7. Please revise yo ur disclosure to provide brief explanations of scientific terms to enable a lay investor to understand. For instance, at first use, please define the following terms: “Stereochemistry technology;” “Stereopure nucleic acid therapeutics;” “Stereoisomer mix tures;” “Antisense;” “oligonucleotide stereochemistry;” Paul B. Bolno, M.D. WAVE Life Sciences Pte. Ltd. October 2, 2015 Page 3 “Ribonucleic acid interference;” “Exon skipping;” “HTT SNP -1 and HTT SNP -2;” “Exon 51;” “SMAD7;” “KRT14 SNP -1 and KRT14 SNP -2;” “Chiral centers;” “directing medicine ‘upstream’ of protein production;” and “splice -correction” Please make corresponding changes to the Prospectus Summary. Proof of Concept of Our Technology , page 74 Efficacy, page 76 8. We note your statement that the results of your preclinical study “ confirm [y]our ability to rationally design PS -modified nucleic acid therapeutics with greater stability, catalytic activity, efficacy and durability .” Because approval of the FDA and other comparable regulatory agencies is dependent on such agencies making a determination (acc ording to criteria specified in law and agency regulations) that a drug or biologic is effective, it is premature for you to describe or suggest that any non-approved product i s effective. Accordingly, please delete this language throughout your registrat ion statement. In addition, please revise your disclosure as necessary to make clear that any observations you make about your products’ potential for efficacy are your own, are not based on the FDA’s or any other comparable governmental agency’s assessme nt and do not indicate that your products will achieve favorable results in any later stage trials or that the FDA or comparable agency will ultimately determine that your product is effective for purposes of granting marketing approval. Immunogenicity, p age 78 9. Please provide a brief explanation of the term “ C3a levels ” for a lay investor to understand. 10. Please provide a brief discussion of enzyme -linked immunosorbent assay (ELISA) analytical method . Our Initial Therapeutic Candidates, page 80 11. Revise this section to clarify which of your candidates will require the Max Planck license in order for you to continue your research and proceed through the approval process. Paul B. Bolno, M.D. WAVE Life Sciences Pte. Ltd. October 2, 2015 Page 4 Intellectual Property, page 87 12. We note your discussion of patents licensed fr om or co -owned with the University of Tokyo or Shin Nippon Biomedical Laboratories, Ltd. Please provide a discussion of the material terms of such license or co -ownership agreements and file the agreements as exhibits to the registration statement. In th e alternative, please provide your analysis for why these patents and the underlying agreements are not material to your business. Competition, page 88 13. To the extent known, please disclose the stage of development of competing product candidates. Genera l 14. Please supplementally provide us with copies of all written communications, as defined in Rule 405 under the Securities Act, that you, or anyone authorized to do so on your behalf, present to potential investors in reliance on Section 5(d) of the Secur ities Act, whether or not they retain copies of the communications. 15. Please confirm that the images included in your draft registration statement are all of the graphic, visual or photographic information you will be including. If you intend to use any additional images, please provide us proofs of such materials. Please note that we may have comments regarding this material. You may contact Lisa Vanjoske at (202) 551 -3614 or Joel Parker , Accounting Branch Chief, at (202) 551 -3651 if you have questions regarding comments on the financial statements and related matters. Please contact Christin a De Rosa at (202) 551 -3577, or Christian Windsor, Special Counsel, at (202) 551 -3419 with any other questions. Sincerely, /s/ Christian Windsor Special Counsel For Suzanne Hayes Assistant Director cc: Via E -mail Matthew J. Gardella Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. One Financial Center Boston, MA 02111 Paul B. Bolno, M.D. WAVE Life Sciences Pte. Ltd. October 2, 2015 Page 5
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