SecProbe.io

Filing text and metadata
Intelligence Terminal Search Probe Scores Topics IPO Watchlist Monthly Activity About API

SEC Company Response from Wave Life Sciences, Inc. (WVE) (CIK 0001631574) (WVE) — Dec 3, 2019

Wave Life Sciences, Inc. (WVE) (CIK 0001631574)
Date: Dec. 3, 2019 · CIK: 0001631574 · Accession: 0001193125-19-304738

AI Filing Summary & Sentiment

Sentiment
Urgency
Document Type
Confidence
SEC Posture
Company Posture

Summary

Reasoning

File numbers found in text: 001-37627

Referenced dates: November 26, 2019

Date
December 2, 2019
Author
Not clearly detected
Form
CORRESP
Company
Wave Life Sciences, Inc. (WVE) (CIK 0001631574)

Letter

Via EDGAR and Courier Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 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.

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)

Research and development services through completion of POM and non-exclusive research and development license for HD

[***]

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.

Research and development services through completion of POM and non-exclusive research and development license for SCA3

[***]

The material right provided for the exclusive option to license, co-develop and co-commercialize HD

[***]

The material right provided for the exclusive option to license, co-develop and co-commercialize ALS and FTD

[***]

The material right provided for the exclusive option to license, co-develop and co-commercialize SCA3

[***]

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.

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.

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

Show Raw Text
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