UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended SeptemberJune 30, 20172023

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ______ to ______

Commission File No. Number: 001-37627

WAVE LIFE SCIENCES LTD.

(Exact name of registrant as specified in its charter)

Singapore

(State or other jurisdiction of

incorporation or organization)

Not applicable98-1356880

(I.R.S. Employer

Identification No.)

8 Cross Street #10-00, PWC Building7 Straits View #12-00, Marina OneEast Tower

Singapore 048424

(Address of principal executive offices)

+65 6236 3388018936

(Registrant’s telephone number)Zip Code)

+656236 3388

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading symbol

Name of each exchange on which registered

$0 Par Value Ordinary Shares

WVE

The Nasdaq Global Market

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes No

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of ‘‘large accelerated filer,’’ ‘‘accelerated filer,’’ ‘‘smaller reporting company,’’ and ‘‘emerging growth company’’ in Rule 12b–212b-2 of the Exchange Act.

Large accelerated filer

Accelerated filer

Non-accelerated filer

(Do not check if a smaller reporting company)

Smaller reporting company

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No

The number of outstanding ordinary shares of the registrant as of November 1, 2017July 27, 2023 was 27,790,022.98,983,261.


WAVE LIFE SCIENCES LTD.

QUARTERLY REPORT ON FORM 10-Q

TABLE OF CONTENTS

Page

PART I - FINANCIAL INFORMATION

35

Item 1. Financial Statements

35

Unaudited Consolidated Balance Sheets

35

Unaudited Consolidated Statements of Operations and Comprehensive Loss

46

Unaudited Consolidated Statements of Comprehensive LossSeries A Preferred Shares and Shareholders' Equity (Deficit)

57

Unaudited Consolidated Statements of Cash Flows

69

Notes to Unaudited Consolidated Financial Statements

710

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

1319

Item 3. Quantitative and Qualitative Disclosures aboutAbout Market Risk

2231

Item 4. Controls and Procedures

2331

PART II - OTHER INFORMATION

2332

Item 1. Legal Proceedings

2332

Item 1A. Risk Factors

2432

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

2432

Item 3. Defaults Upon Senior Securities

2432

Item 4. Mine Safety Disclosures

2432

Item 5. Other Information

2432

Item 6. Exhibits

3233

2


PART I - FINANCIAL INFORMATION

Item 1. Financial Statements.

WAVE LIFE SCIENCES LTD.

UNAUDITED CONSOLIDATED BALANCE SHEETS

(In thousands, except share amounts)

 

 

September 30, 2017

 

 

December 31, 2016

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

168,464

 

 

$

150,293

 

Prepaid expenses and other current assets

 

 

5,370

 

 

 

1,483

 

Deferred tax assets

 

 

 

 

 

214

 

Total current assets

 

 

173,834

 

 

 

151,990

 

Property and equipment, net

 

 

24,584

 

 

 

8,607

 

Deferred tax assets

 

 

 

 

 

560

 

Restricted cash

 

 

3,608

 

 

 

3,601

 

Other assets

 

 

60

 

 

 

53

 

Total assets

 

$

202,086

 

 

$

164,811

 

Liabilities, Series A preferred shares and shareholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

4,705

 

 

$

4,943

 

Accrued expenses and other current liabilities

 

 

6,953

 

 

 

4,434

 

Current portion of capital lease obligation

 

 

31

 

 

 

62

 

Current portion of deferred rent

 

 

50

 

 

 

 

Current portion of deferred revenue

 

 

2,705

 

 

 

2,705

 

Current portion of lease incentive obligation

 

 

678

 

 

 

11

 

Total current liabilities

 

 

15,122

 

 

 

12,155

 

Long-term liabilities:

 

 

 

 

 

 

 

 

Capital lease obligation, net of current portion

 

 

 

 

 

16

 

Deferred rent, net of current portion

 

 

3,837

 

 

 

680

 

Deferred revenue, net of current portion

 

 

6,283

 

 

 

8,311

 

Lease incentive obligation, net of current portion

 

 

2,093

 

 

 

116

 

Other liabilities

 

 

1,021

 

 

 

796

 

Total long-term liabilities

 

 

13,234

 

 

 

9,919

 

Total liabilities

 

$

28,356

 

 

$

22,074

 

Series A preferred shares, no par value; 3,901,348 shares issued and outstanding

   at September 30, 2017 and December 31, 2016

 

$

7,874

 

 

$

7,874

 

Shareholders’ equity:

 

 

 

 

 

 

 

 

Ordinary shares, no par value; 27,767,905 and 23,502,169 shares issued and

   outstanding at September 30, 2017 and December 31, 2016, respectively

 

$

309,434

 

 

$

215,602

 

Additional paid-in capital

 

 

18,995

 

 

 

10,029

 

Accumulated other comprehensive loss

 

 

(272

)

 

 

(291

)

Accumulated deficit

 

 

(162,301

)

 

 

(90,477

)

Total shareholders’ equity

 

$

165,856

 

 

$

134,863

 

Total liabilities, Series A preferred shares and shareholders’ equity

 

$

202,086

 

 

$

164,811

 

The accompanying notes are an integral part of the unaudited consolidated financial statements.

3


WAVE LIFE SCIENCES LTD.

UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except share and per share amounts)

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Revenue

 

$

676

 

 

$

392

 

 

$

2,028

 

 

$

809

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

20,097

 

 

 

13,686

 

 

 

53,940

 

 

 

26,823

 

General and administrative

 

 

7,571

 

 

 

3,939

 

 

 

20,088

 

 

 

10,809

 

Total operating expenses

 

 

27,668

 

 

 

17,625

 

 

 

74,028

 

 

 

37,632

 

Loss from operations

 

 

(26,992

)

 

 

(17,233

)

 

 

(72,000

)

 

 

(36,823

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Dividend income

 

 

515

 

 

 

 

 

 

1,287

 

 

 

 

Interest income (expense), net

 

 

1

 

 

 

118

 

 

 

5

 

 

 

328

 

Other income (expense), net

 

 

(75

)

 

 

(36

)

 

 

(211

)

 

 

(25

)

Total other income (expense), net

 

 

441

 

 

 

82

 

 

 

1,081

 

 

 

303

 

Loss before income taxes

 

 

(26,551

)

 

 

(17,151

)

 

 

(70,919

)

 

 

(36,520

)

Income tax benefit (provision)

 

 

416

 

 

 

(384

)

 

 

(905

)

 

 

(427

)

Net loss

 

$

(26,135

)

 

$

(17,535

)

 

$

(71,824

)

 

$

(36,947

)

Net loss per share attributable to ordinary shareholders—

   basic and diluted

 

$

(0.94

)

 

$

(0.75

)

 

$

(2.75

)

 

$

(1.64

)

Weighted-average ordinary shares used in computing net loss

   per share attributable to ordinary shareholders—basic

   and diluted

 

 

27,758,792

 

 

 

23,445,673

 

 

 

26,078,696

 

 

 

22,571,575

 

The accompanying notes are an integral part of the unaudited consolidated financial statements.

4


WAVE LIFE SCIENCES LTD.

UNAUDITED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

(In thousands)

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

Net loss

 

$

(26,135

)

 

$

(17,535

)

 

$

(71,824

)

 

$

(36,947

)

Other comprehensive income (loss):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Foreign currency translation

 

 

1

 

 

 

8

 

 

 

19

 

 

 

43

 

Comprehensive loss

 

$

(26,134

)

 

$

(17,527

)

 

$

(71,805

)

 

$

(36,904

)

The accompanying notes are an integral part of the unaudited consolidated financial statements.

5


WAVE LIFE SCIENCES LTD.

UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

 

 

Nine Months Ended September 30,

 

 

 

2017

 

 

2016

 

Cash flows from operating activities

 

 

 

 

 

 

 

 

Net loss

 

$

(71,824

)

 

$

(36,947

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

 

 

Amortization of lease incentive obligation

 

 

(131

)

 

 

 

Depreciation of property and equipment

 

 

1,266

 

 

 

525

 

Share-based compensation expense

 

 

8,966

 

 

 

4,319

 

Deferred rent

 

 

3,207

 

 

 

371

 

Tax benefit related to share-based compensation

 

 

 

 

 

(67

)

Deferred income taxes

 

 

774

 

 

 

178

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts receivable

 

 

 

 

 

(2,500

)

Prepaid expenses and other current assets

 

 

(3,887

)

 

 

(466

)

Other non-current assets

 

 

(7

)

 

 

(53

)

Accounts payable

 

 

624

 

 

 

1,899

 

Accrued expenses and other current liabilities

 

 

1,898

 

 

 

2,484

 

Deferred revenue

 

 

(2,028

)

 

 

11,692

 

Other non-current liabilities

 

 

225

 

 

 

(13

)

Net cash used in operating activities

 

 

(60,917

)

 

 

(18,578

)

Cash flows from investing activities

 

 

 

 

 

 

 

 

Increase in restricted cash

 

 

(7

)

 

 

 

Proceeds from the sale of property and equipment

 

 

 

 

 

4

 

Purchases of property and equipment

 

 

(14,808

)

 

 

(2,838

)

Net cash used in investing activities

 

 

(14,815

)

 

 

(2,834

)

Cash flows from financing activities

 

 

 

 

 

 

 

 

Proceeds from issuance of ordinary shares, net of offering costs

 

 

93,509

 

 

 

30,000

 

Costs associated with initial public offering

 

 

 

 

 

(1,075

)

Payments on capital lease obligation

 

 

(47

)

 

 

(47

)

Tax benefit related to share-based compensation

 

 

 

 

 

67

 

Proceeds from the exercise of share options

 

 

323

 

 

 

161

 

Net cash provided by financing activities

 

 

93,785

 

 

 

29,106

 

Effect of foreign exchange rates on cash

 

 

118

 

 

 

101

 

Net increase in cash and cash equivalents

 

 

18,171

 

 

 

7,795

 

Cash and cash equivalents at beginning of period

 

 

150,293

 

 

 

161,220

 

Cash and cash equivalents at end of period

 

$

168,464

 

 

$

169,015

 

Supplemental disclosure of cash flow information:

 

 

 

 

 

 

 

 

Tenant improvements paid for by the landlord during the period

 

$

2,774

 

 

$

 

Property and equipment purchases in accounts payable and

  accrued expenses at period end

 

$

1,419

 

 

$

1,595

 

The accompanying notes are an integral part of the unaudited consolidated financial statements.

6


Wave Life Sciences Ltd.

Notes to Unaudited Consolidated Financial Statements

1. THE COMPANY

Organization

Wave Life Sciences Ltd. (together with its subsidiaries, “Wave” or the “Company”) is a biotechnology company with an innovative and proprietary synthetic chemistry drug development platform that the Company is using to design, develop and commercialize a broad pipeline of first-in-class or best-in-class nucleic acid therapeutic candidates for genetically defined diseases. The Company is initially developing oligonucleotides that target genetic defects to either reduce the expression of disease-promoting proteins or transform the production of dysfunctional mutant proteins into the production of functional proteins.

The Company was incorporated in Singapore on July 23, 2012 and has its principal U.S. office in Cambridge, Massachusetts. The Company was incorporated with the purpose of combining two commonly held companies, Wave Life Sciences USA, Inc. (“Wave USA”), a Delaware corporation (formerly Ontorii, Inc.), and Wave Life Sciences Japan, Inc. (“Wave Japan”), a company organized under the laws of Japan (formerly Chiralgen., Ltd.), which occurred on September 13, 2012. On May 31, 2016, Wave Life Sciences Ireland Limited (“Wave Ireland”) was formed as a wholly-owned subsidiary of Wave Life Sciences Ltd. On April 3, 2017, Wave Life Sciences UK Limited (“Wave UK”) was formed as a wholly-owned subsidiary of Wave Life Sciences Ltd.

The Company’s primary activities since inception have been developing a synthetic chemistry drug development platform to design, develop and commercialize nucleic acid therapeutic programs, advancing the Company’s neurology franchise, expanding the Company’s research and development activities, advancing programs into the clinic, furthering clinical development of such clinical-stage programs, building the Company’s intellectual property, recruiting personnel and assuring adequate capital to support these activities.

Risks and Uncertainties

The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, developing internal manufacturing capabilities, dependence on key personnel, compliance with government regulations and the need to obtain additional financing. The Company’s therapeutic programs will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to commercialization of any product candidates. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance-reporting capabilities. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition from pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees and consultants.

Basis of Presentation

The Company has prepared the accompanying consolidated financial statements in conformity with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and in U.S. dollars.

2. SIGNIFICANT ACCOUNTING POLICIES

The significant accounting policies described in the Company’s audited financial statements as of and for the year ended December 31, 2016, and the notes thereto, which are included in the Company’s 2016 Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 16, 2017, have had no material changes during the three and nine months ended September 30, 2017.

Unaudited Interim Financial Data

The accompanying interim consolidated balance sheet as of September 30, 2017, the related interim consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2017 and 2016 and cash flows for the nine months ended September 30, 2017 and 2016, and the related interim information contained within the notes to the consolidated financial statements have been prepared in accordance with the rules and regulations of the SEC for interim financial information. Accordingly, they do not include all of the information and the notes required by U.S. GAAP for complete financial statements. The

7


financial data and other information disclosed in these notes related to the three and nine months ended September 30, 2017 and 2016 are unaudited. In the opinion of management, the unaudited interim consolidated financial statements reflect all adjustments, consisting of normal and recurring adjustments, necessary for the fair presentation of the Company’s financial position and results of operations for the three and nine months ended September 30, 2017 and 2016. The results of operations for the interim periods are not necessarily indicative of the results to be expected for the year ending December 31, 2017 or any other interim period or future year or period.

Principles of Consolidation

The Company’s consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation.

Recently Issued Accounting Pronouncements

The recently issued accounting pronouncements described in the Company’s audited financial statements as of and for the year ended December 31, 2016, and the notes thereto, which are included in the Company’s 2016 Annual Report on Form 10-K filed with the SEC on March 16, 2017, have had no material changes during the three and nine months ended September 30, 2017, except as described below.

In May 2014, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers (Topic 606) (“ASU 2014-09”), which supersedes all existing revenue recognition requirements, including most industry-specific guidance. The new standard requires a company to recognize revenue when it transfers goods or services to customers in an amount that reflects the consideration that the company expects to receive for those goods or services. The new standard will be effective on January 1, 2018 and earlier application is permitted only for annual reporting periods beginning after December 15, 2016, including interim reporting periods within that reporting period.  For the year ended December 31, 2016 and the nine months ended September 30, 2017, revenue was generated exclusively from the Pfizer Collaboration Agreement. The Company is currently evaluating the potential impact that ASU 2014-09 may have on its financial position and results of operations as it relates to this single arrangement, and expects to elect the modified retrospective application as its transition method.

In November 2015, the FASB issued Accounting Standards Update No. 2015-17, Balance Sheet Classification of Deferred Taxes (“ASU 2015-17”), which requires entities to present deferred tax assets and liabilities, along with any related valuation allowance, as noncurrent on the balance sheet. The new standard is effective for annual and interim periods beginning after December 15, 2016. During the three months ended March 31, 2017, the Company elected to adopt ASU 2015-17 on a prospective basis. The adoption of this standard resulted in the reclassification of short-term deferred tax assets to long-term deferred tax assets.

In October 2016, the FASB issued Accounting Standards Update No. 2016-16, Income Taxes (Topic 740): Intra-Entity Transfers of Assets Other Than Inventory (“ASU 2016-16”).  The new standard requires companies to recognize the income tax consequences of an intra-entity transfer of an asset other than inventory when the transfer occurs. Prior to the issuance of this standard, existing guidance prohibited the recognition of current and deferred income taxes for an intra-entity asset transfer until the asset has been sold to an outside party. ASU 2016-16 will be effective for the Company in the first quarter of 2018 with early adoption permitted. The Company is currently evaluating the potential impact that the adoption of ASU 2016-16 may have on its consolidated financial statements.

3. SHARE-BASED COMPENSATION

The Wave Life Sciences Ltd. 2014 Equity Incentive Plan (the “2014 Plan”) authorizes the board of directors or a committee of the board to grant incentive share options, non-qualified share options, share appreciation rights and restricted share awards to eligible employees, outside directors and consultants of the Company. Options generally vest over periods of one to four years, and options that expire or are forfeited are available to be granted again. The contractual life of all options is generally five or ten years from the grant date.

As of September 30, 2017, 1,730,546 ordinary shares remained available for future grant under the 2014 Plan.

The Company measures and records the value of options granted to non-employees over the period of time that services are provided and, as such, unvested portions are subject to re-measurement at subsequent reporting periods.

8


Share Options

Share option activity under the 2014 Plan for the nine months ended September 30, 2017 is summarized as follows:

 

 

Number of

Shares

 

 

Weighted-

Average

Exercise Price

 

Options outstanding as of January 1, 2017

 

 

3,577,766

 

 

$

10.58

 

Granted

 

 

414,000

 

 

 

25.55

 

Exercised

 

 

(76,319

)

 

 

4.24

 

Canceled or forfeited

 

 

(109,652

)

 

 

16.79

 

Outstanding as of September 30, 2017

 

 

3,805,795

 

 

 

12.26

 

Options exercisable as of September 30, 2017

 

 

2,042,259

 

 

 

6.62

 

Options unvested as of September 30, 2017

 

 

1,763,536

 

 

 

18.79

 

The Company recorded share-based compensation expense related to options granted to non-employees in the amount of $0.6 million and $0.9 million for the three months ended September 30, 2017 and 2016, respectively. During the nine months ended September 30, 2017 and 2016, the Company recorded share-based compensation expense related to options granted to non-employees in the amount of $1.9 million and $1.9 million, respectively. Share-based compensation expense related to non-employees is recorded in research and development expenses.

Restricted Share Units

Restricted share unit (“RSU”) activity for the nine months ended September 30, 2017 is summarized as follows:

 

 

RSUs

 

 

Average Grant

Date Fair Value

(in dollars

per share)

 

RSUs Outstanding as of January 1, 2017

 

 

22,750

 

 

$

21.69

 

Granted

 

 

170,859

 

 

 

29.05

 

Vested

 

 

(22,750

)

 

 

21.69

 

Canceled or forfeited

 

 

(8,579

)

 

 

29.05

 

RSUs Outstanding at September 30, 2017

 

 

162,280

 

 

 

29.05

 

The RSUs granted in 2016 fully vested during the three months ended September 30, 2017 upon the first anniversary of the grant date. The RSUs granted in 2017 vest over a four-year period. Any RSUs that are forfeited or canceled are available to be granted again.

Share-based compensation expense for the three and nine months ended September 30, 2017 and 2016 was classified in the consolidated statements of operations as follows:

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

 

(in thousands)

 

Research and development expenses

 

$

1,759

 

 

$

1,695

 

 

$

5,527

 

 

$

3,207

 

General and administrative expenses

 

 

1,241

 

 

 

486

 

 

 

3,439

 

 

 

1,112

 

Total share-based compensation

 

$

3,000

 

 

$

2,181

 

 

$

8,966

 

 

$

4,319

 

4. PFIZER COLLABORATION AND SHARE PURCHASE AGREEMENT

On May 5, 2016, the Company entered into a Research, License and Option Agreement (the “Pfizer Collaboration Agreement”) with Pfizer Inc. (“Pfizer”). Pursuant to the terms of the Pfizer Collaboration Agreement, the Company and Pfizer agreed to collaborate on the discovery, development and commercialization of stereopure oligonucleotide therapeutics for up to five programs (the “Pfizer Programs”), each directed at a genetically-defined hepatic target selected by Pfizer (the “Collaboration”).  The Company received $10.0 million as an upfront license fee under the Pfizer Collaboration Agreement.  Subject to option exercises by Pfizer, assuming five potential products are successfully developed and commercialized, the Company may earn up to $871.0 million in potential research, development and commercial milestone payments, plus royalties, tiered up to low double-digits, on sales of any products that may result from the Collaboration. None of the payments under the Pfizer Collaboration Agreement are refundable.

9


Simultaneously with the entry into the Pfizer Collaboration Agreement, the Company entered into a Share Purchase Agreement (the “Pfizer Equity Agreement,” and together with the Pfizer Collaboration Agreement, the “Pfizer Agreements”) with C.P. Pharmaceuticals International C.V., an affiliate of Pfizer (the “Pfizer Affiliate”). Pursuant to the terms of the Pfizer Equity Agreement, the Pfizer Affiliate purchased 1,875,000 of the Company’s ordinary shares (the “Shares”) at a purchase price of $16.00 per share, for an aggregate purchase price of $30.0 million. The Company did not incur any material costs in connection with the issuance of the Shares.

Under the Pfizer Collaboration Agreement, the parties agreed to collaborate during the four-year Research Term. During the Research Term, the Company is responsible to use its commercially reasonable efforts to advance up to five programs through to the selection of clinical candidates. At that stage, Pfizer may elect to license any of these Pfizer Programs exclusively and to have exclusive rights to undertake the clinical development of the resulting clinical candidates into products and the potential commercialization of any such products thereafter. In addition, the Company receives a non-exclusive, royalty-bearing sublicensable license to use Pfizer’s hepatic targeting technology in any of the Company’s own hepatic programs that are outside the scope of the Collaboration (the “Wave Programs”). If the Company uses this technology on the Wave Programs, Pfizer is eligible to receive potential development and commercial milestone payments from the Company. Pfizer is also eligible to receive tiered royalties on sales of any products that include Pfizer’s hepatic targeting technology.

Pfizer nominated two hepatic targets upon entry into the Collaboration in May 2016. In August 2016, Pfizer nominated the third hepatic target under the Collaboration and pursuant to the terms of the Pfizer Collaboration Agreement, Pfizer had the option to nominate two additional targets by November 5, 2017. On November 5, 2017, the Company amended its Pfizer Collaboration Agreement to extend the target nomination period from November 5, 2017 to May 5, 2018. This amendment provides Pfizer with an additional six months to nominate the two remaining hepatic targets under the Pfizer Collaboration Agreement. The Collaboration is managed by a joint steering committee in which both parties are represented equally, which will oversee the scientific progression of each Pfizer Program up to the clinical candidate stage. During the four-year Research Term and for a period of two years thereafter, the Company has agreed to work exclusively with Pfizer with respect to using any of the Company’s stereopure oligonucleotide technology that is specific for the applicable hepatic target which is the basis of any Pfizer Program.  

The stated term of the Pfizer Collaboration Agreement commenced on May 5, 2016 and terminates, with respect to each Pfizer Program, on the date of the last to expire payment obligations and expires, with respect to each Wave Program, on a program-by-program basis accordingly. Pfizer may terminate its rights related to a Pfizer Program under the Pfizer Collaboration Agreement at its own convenience upon 90 days’ notice to the Company. The Company may also terminate its rights related to a Wave Program at its own convenience upon 90 days’ notice to Pfizer. The Pfizer Collaboration Agreement may also be terminated by either party in the event of an uncured material breach of the Pfizer Collaboration Agreement by the other party.

During the three and nine months ended September 30, 2017, the Company recognized revenue of $0.7 million and $2.0 million, respectively, under the Pfizer Collaboration Agreement. During the three and nine months ended September 30, 2016, the Company recognized revenue of $0.4 million and $0.8 million, respectively, under the Pfizer Collaboration Agreement. Deferred revenue amounted to $9.0 million at September 30, 2017, of which $2.7 million is included in current liabilities.

5. NET LOSS PER ORDINARY SHARE

The Company applies the two-class method to calculate its basic and diluted net loss per share attributable to ordinary shareholders, as its Series A preferred shares are participating securities. The two-class method is an earnings allocation formula that treats a participating security as having rights to earnings that otherwise would have been available to ordinary shareholders. However, for the periods presented, the two-class method does not impact the net loss per ordinary share as the Company was in a net loss position for each of the periods presented and holders of Series A preferred shares do not participate in losses.

Basic loss per share is computed by dividing net loss attributable to ordinary shareholders by the weighted-average number of ordinary shares used in computing net loss per share attributable to ordinary shareholders.

The Company’s potentially dilutive shares, which include outstanding share options to purchase ordinary shares and Series A preferred shares, are considered to be ordinary share equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive.

10


The following ordinary share equivalents, presented based on amounts outstanding at each period end, were excluded from the calculation of diluted net loss per share attributable to ordinary shareholders for the periods indicated because including them would have had an anti-dilutive effect:

 

 

As of September 30,

 

 

 

2017

 

 

2016

 

Options to purchase ordinary shares

 

 

3,805,795

 

 

 

3,509,242

 

Restricted share units

 

 

162,280

 

 

 

22,750

 

Series A preferred shares

 

 

3,901,348

 

 

 

3,901,348

 

6. INCOME TAXES

The Company is a multi-national company subject to taxation in the United States and various other jurisdictions. During the three months ended September 30, 2017 and 2016, the Company recorded an income tax benefit of $0.4 million and an income tax provision of $0.4 million, respectively. The income tax benefit recorded during the three months ended September 30, 2017 was due to the implementation of a revised international corporate structure aligned with the Company’s international operations. The income tax provision recorded during the three months ended September 30, 2016 was primarily the result of U.S. income generated under research and management services arrangements between the Company’s U.S. and Singapore entities.

During the nine months ended September 30, 2017 and 2016, the Company recorded an income tax provision of $0.9 million and $0.4 million, respectively. The increase in the income tax provision for the nine months ended September 30, 2017 as compared to the nine months ended September 30, 2016 was a result of the Company’s establishment of a valuation allowance against the Company’s U.S. deferred tax assets.

During the three and nine months ended September 30, 2017 and 2016, the Company recorded no income tax benefits for the net operating losses incurred in Japan, Singapore, Ireland or the United Kingdom, due to its uncertainty of realizing a benefit from those items.

The Company’s reserves related to taxes and its accounting for uncertain tax positions are based on a determination of whether and how much of a tax benefit taken by the Company in its tax filings or positions is more-likely-than-not to be realized following resolution of any potential contingencies present related to the tax benefit.

7. RELATED PARTIES

The Company had the following related party transactions for the periods presented in the accompanying consolidated financial statements, which have not otherwise been discussed in these notes to the consolidated financial statements:

The Company had cash of $109 thousand and $118 thousand at September 30, 2017 and December 31, 2016, respectively, in depository accounts with Kagoshima Bank, Ltd., an affiliate of one of the Company’s shareholders, Kagoshima Shinsangyo Sousei Investment Limited Partnership.

Pursuant to the terms of various service agreements with Shin Nippon Biomedical Laboratories Ltd. (“SNBL”), one of the Company’s shareholders, the Company paid SNBL $83 thousand and $4 thousand during the three months ended September 30, 2017 and 2016, respectively, and $161 thousand and $329 thousand during the nine months ended September 30, 2017 and 2016, respectively, for contract research services provided to the Company and its affiliates.

In 2012, the Company entered into a consulting agreement for scientific advisory services with Dr. Gregory L. Verdine, one of the Company’s founders and a member of the Company’s Board of Directors. The consulting agreement does not have a specific term and may be terminated by either party upon 14 days’ prior written notice. Pursuant to the consulting agreement, the Company pays Dr. Verdine approximately $13 thousand per month, plus reimbursement of certain expenses.

11


8. GEOGRAPHIC DATA

The Company’s long-lived assets consist of property and equipment, net and are located in the following geographical areas:

 

 

September 30, 2017

 

 

December 31, 2016

 

 

 

(in thousands)

 

Asia

 

$

13

 

 

$

136

 

United States

 

 

24,571

 

 

 

8,471

 

Total long-lived assets

 

$

24,584

 

 

$

8,607

 

9. SUBSEQUENT EVENT

On November 5, 2017, the Pfizer Collaboration Agreement was amended to extend the target nomination period from November 5, 2017 to May 5, 2018. This amendment provides Pfizer with an additional six months to nominate the two remaining hepatic targets under the Pfizer Collaboration Agreement.

12


Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q, unless otherwise stated or the context otherwise indicates, references to “Wave,” the “Company,” “we,” “our,” “us” or similar terms refer to Wave Life Sciences Ltd. and in our Annual Report on Form 10-K for the year ended December 31, 2016, filed with the Securities and Exchange Commission (“SEC”) on March 16, 2017 (the “2016 Annual Report on Form 10-K”). Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth under the caption “Risk Factors” in this Quarterly Report on Form 10-Q, our actual results could differ materially from the results described in, or implied by, these forward-looking statements.wholly-owned subsidiaries.

Special Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), that involve substantialrelate to future events or to our future operations or financial performance. Any forward-looking statement involves known and unknown risks, uncertainties and uncertainties.other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by such forward-looking statement. In some cases, forward-looking statements are identified by the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “future,” “goals,” “intend,” “likely,” “may,” “might,” “ongoing,” “objective,” “plan,” “potential,” “predict,” “project,” “seek,” “should,” “strategy,” “target,” “will” and “would” or the negative of these terms, or other comparable terminology intended to identify statements about the future.future, although not all forward-looking statements contain these identifying words. Forward-looking statements include statements, other than statements of historical fact, about, among other things: our ability to fund our workingfuture operations; our financial position, revenues, costs, expenses, uses of cash and capital requirements; our need for additional financing or the period for which our existing cash resources will be sufficient to meet our operating requirements; the success, progress, number, scope, cost, andduration, timing or results of our productresearch and development activities, preclinical studies and currentclinical trials, including the timing for initiation or completion of or availability of results from any preclinical studies and future clinical trials;trials or for submission, review or approval of any regulatory filing; the timing of, and our ability to, obtain and maintain regulatory approvals for any of our product candidates; the potential benefits that may be derived from any of our product candidates; our strategies, prospects, plans, goals, expectations, forecasts or objectives; the success of our collaborations with third parties; any payment that our collaboration partners may make to us; our ability to identify and develop new product candidates; our intellectual property position; our manufacturing, commercialization, marketing and marketingmanufacturing capabilities and strategy; our ability to develop sales and marketing capabilities; our use of proceeds from our equity offerings; our estimates regarding future expenses and needs for additional financing; our ability to develop sales and marketing capabilities; our ability to identify, recruit and retain key personnel; our financial performance; developments and projections relating to our competitive position;competitors in the industry; our liquidity and working capital requirements; and the expected impact of new accounting standards. Thesestandards; and our expectations regarding the impact of the coronavirus (“COVID-19”) and variants thereof on our business, including on our research and development activities, preclinical studies and clinical trials, supply of drug product, and workforce.

Although we believe that we have a reasonable basis for each forward-looking statement contained in this report, we caution you that these statements involveare based on our estimates or projections of the future that are subject to known and unknown risks and uncertainties and other important factors that may cause our actual results, levelslevel of activity, performance or achievements to be materially different from the information expressed or implied by these statements, including the following:any forward-looking statement to differ. These risks, uncertainties and other factors include, among other things, our critical accounting policies; the ability of our preclinical studies to produce data sufficient to support the filing of global clinical trial applications and the timing thereof; our ability to continue to build and maintain the company infrastructure and personnel needed to achieve our goals; the clinical results and timing of our programs, which may not support further development of our product candidates; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials; our effectiveness in managing current and future clinical trials and regulatory processes; the success of our platform in identifying viable candidates; the continued development and acceptance of nucleic acid therapeutics as a class of drugs; our ability to demonstrate the therapeutic benefits of our stereopure candidates in clinical trials, including our ability to develop candidates across multiple therapeutic modalities; our ability to obtain, maintain and protect intellectual property; our ability to enforce our patents against infringers and defend our patent portfolio against challenges from third parties; our ability to fund our operations and to raise additional capital as needed; and competition from others developing therapies for similar uses, uses; any impacts on our business as a result of or related to the COVID-19 pandemic, the conflict involving Russia and Ukraine, global economic uncertainty, rising inflation, rising interest rates or market disruptions, as well as the informationother risks and uncertainties under the caption “Risk Factors” contained in this Quarterly Report on Form 10-Q and in other filings we make with the SEC. IfSecurities and Exchange Commission (the “SEC”).

3


Each forward-looking statement contained in this report is based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. As a result of these factors, we cannot assure you that the forward-looking statements in this Quarterly Report on Form 10-Q will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, these statements should not be regarded as representations or warranties by us or any other person that we will achieve our objectives and plans in any specified time frame,timeframe, or at all. We caution you not to place undue reliance on any forward-looking statement.

In addition, any forward-looking statement in this report represents our views only as of the date of this report and should not be relied upon as representing our views as of any subsequent date. We anticipate that subsequent events and developments may cause our views to change. Although we may elect to update these forward-looking statements publicly at some point in the future, we undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments we may make.

As used

The Wave Life Sciences Ltd. and Wave Life Sciences Pte. Ltd. names, the Wave Life Sciences mark, PRISM and the other registered and pending trademarks, trade names and service marks of Wave Life Sciences Ltd. appearing in this Quarterly Report on Form 10-Q unless otherwise stated orare the context otherwise indicates, references to “Wave,” the “Company,” “we,” “our,” “us” or similar terms referproperty of Wave Life Sciences Ltd. This Quarterly Report on Form 10-Q also contains additional trade names, trademarks and service marks belonging to Wave Life Sciences Ltd. and to other companies. We do not intend our wholly-owned subsidiaries.use or display of other parties’ trademarks, trade names or service marks to imply, and such use or display should not be construed to imply, a relationship with, or endorsement or sponsorship of us by, these other parties. Solely for convenience, the trademarks and trade names in this Quarterly Report on Form 10-Q are referred to without the ® and ™ symbols, but such reference should not be construed as any indicator that their respective owners will not assert, to the fullest extent under applicable law, their rights thereto.

Overview4


WePART I - FINANCIAL INFORMATION

Item 1. Financial Statements

WAVE LIFE SCIENCES LTD.

UNAUDITED CONSOLIDATED BALANCE SHEETS

(In thousands, except share amounts)

 

 

June 30, 2023

 

 

December 31, 2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

172,974

 

 

$

88,497

 

Prepaid expenses

 

 

9,012

 

 

 

7,932

 

Other current assets

 

 

2,722

 

 

 

2,108

 

Total current assets

 

 

184,708

 

 

 

98,537

 

Long-term assets:

 

 

 

 

 

 

Property and equipment, net of accumulated depreciation of $40,423 and $37,846 
   as of June 30, 2023 and December 31, 2022, respectively

 

 

14,983

 

 

 

17,284

 

Operating lease right-of-use assets

 

 

24,805

 

 

 

26,843

 

Restricted cash

 

 

3,668

 

 

 

3,660

 

Other assets

 

 

1,821

 

 

 

62

 

Total long-term assets

 

 

45,277

 

 

 

47,849

 

Total assets

 

$

229,985

 

 

$

146,386

 

Liabilities, Series A preferred shares and shareholders’ equity (deficit)

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

12,379

 

 

$

16,915

 

Accrued expenses and other current liabilities

 

 

10,429

 

 

 

17,552

 

Current portion of deferred revenue

 

 

111,133

 

 

 

31,558

 

Current portion of operating lease liability

 

 

6,285

 

 

 

5,496

 

Total current liabilities

 

 

140,226

 

 

 

71,521

 

Long-term liabilities:

 

 

 

 

 

 

Deferred revenue, net of current portion

 

 

104,540

 

 

 

79,774

 

Operating lease liability, net of current portion

 

 

28,875

 

 

 

32,118

 

Other liabilities

 

 

190

 

 

 

190

 

Total long-term liabilities

 

 

133,605

 

 

 

112,082

 

Total liabilities

 

$

273,831

 

 

$

183,603

 

Series A preferred shares, no par value; 3,901,348 shares
   issued and outstanding at June 30, 2023 and December 31, 2022

 

$

7,874

 

 

$

7,874

 

Shareholders’ equity (deficit):

 

 

 

 

 

 

Ordinary shares, no par value; 98,566,816 and 86,924,643 shares
   issued and outstanding at June 30, 2023 and December 31, 2022, respectively

 

$

839,675

 

 

$

802,833

 

Additional paid-in capital

 

 

124,601

 

 

 

119,442

 

Accumulated other comprehensive loss

 

 

(150

)

 

 

(29

)

Accumulated deficit

 

 

(1,015,846

)

 

 

(967,337

)

Total shareholders’ deficit

 

$

(51,720

)

 

$

(45,091

)

Total liabilities, Series A preferred shares and shareholders’ deficit

 

$

229,985

 

 

$

146,386

 

The accompanying notes are an integral part of the unaudited consolidated financial statements.

5


WAVE LIFE SCIENCES LTD.

UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share amounts)

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Revenue

 

$

22,106

 

 

$

375

 

 

$

35,035

 

 

$

2,125

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

33,314

 

 

 

29,733

 

 

 

64,293

 

 

 

57,203

 

General and administrative

 

 

12,265

 

 

 

12,806

 

 

 

24,500

 

 

 

25,180

 

Total operating expenses

 

 

45,579

 

 

 

42,539

 

 

 

88,793

 

 

 

82,383

 

Loss from operations

 

 

(23,473

)

 

 

(42,164

)

 

 

(53,758

)

 

 

(80,258

)

Other income, net:

 

 

 

 

 

 

 

 

 

 

 

 

Dividend income and interest income, net

 

 

2,251

 

 

 

124

 

 

 

4,124

 

 

 

150

 

Other income, net

 

 

118

 

 

 

744

 

 

 

1,125

 

 

 

998

 

Total other income, net

 

 

2,369

 

 

 

868

 

 

 

5,249

 

 

 

1,148

 

Loss before income taxes

 

 

(21,104

)

 

 

(41,296

)

 

 

(48,509

)

 

 

(79,110

)

Income tax provision

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(21,104

)

 

$

(41,296

)

 

$

(48,509

)

 

$

(79,110

)

Net loss per share attributable to ordinary
   shareholders—basic and diluted

 

$

(0.20

)

 

$

(0.62

)

 

$

(0.47

)

 

$

(1.25

)

Weighted-average ordinary shares used in
   computing net loss per share attributable to
   ordinary shareholders—basic and diluted

 

 

105,462,414

 

 

 

66,479,293

 

 

 

103,768,971

 

 

 

63,514,426

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(21,104

)

 

$

(41,296

)

 

$

(48,509

)

 

$

(79,110

)

Foreign currency translation

 

 

(100

)

 

 

(142

)

 

 

(121

)

 

 

(228

)

Comprehensive loss

 

$

(21,204

)

 

$

(41,438

)

 

$

(48,630

)

 

$

(79,338

)

The accompanying notes are an integral part of the unaudited consolidated financial statements.

6


WAVE LIFE SCIENCES LTD.

UNAUDITED CONSOLIDATED STATEMENTS OF SERIES A PREFERRED SHARES AND SHAREHOLDERS’ EQUITY (DEFICIT)

(In thousands, except share amounts)

 

 

Series A
Preferred Shares

 

 

 

Ordinary Shares

 

 

Additional
Paid-In-

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Shareholders’

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity (Deficit)

 

Balance at December 31, 2021

 

 

3,901,348

 

 

$

7,874

 

 

 

 

59,841,116

 

 

$

749,851

 

 

$

87,980

 

 

$

181

 

 

$

(805,514

)

 

$

32,498

 

Issuance of ordinary shares
   pursuant to the at-the-market
   equity program, net

 

 

 

 

 

 

 

 

 

458,092

 

 

 

1,167

 

 

 

 

 

 

 

 

 

 

 

 

1,167

 

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,971

 

 

 

 

 

 

 

 

 

3,971

 

Vesting of RSUs

 

 

 

 

 

 

 

 

 

468,226

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Option exercises

 

 

 

 

 

 

 

 

 

15,000

 

 

 

37

 

 

 

 

 

 

 

 

 

 

 

 

37

 

Issuance of ordinary shares
   under the ESPP

 

 

 

 

 

 

 

 

 

77,534

 

 

 

174

 

 

 

 

 

 

 

 

 

 

 

 

174

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(86

)

 

 

 

 

 

(86

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(37,814

)

 

 

(37,814

)

Balance at March 31, 2022

 

 

3,901,348

 

 

$

7,874

 

 

 

 

60,859,968

 

 

$

751,229

 

 

$

91,951

 

 

$

95

 

 

$

(843,328

)

 

$

(53

)

Issuance of ordinary shares,
   net of offering costs

 

 

 

 

 

 

 

 

 

25,464,483

 

 

 

51,220

 

 

 

 

 

 

 

 

 

 

 

 

51,220

 

Issuance of pre-funded warrants,
   net of offering costs

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

14,268

 

 

 

 

 

 

 

 

 

14,268

 

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6,950

 

 

 

 

 

 

 

 

 

6,950

 

Vesting of RSUs

 

 

 

 

 

 

 

 

 

400,207

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(142

)

 

 

 

 

 

(142

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(41,296

)

 

 

(41,296

)

Balance at June 30, 2022

 

 

3,901,348

 

 

$

7,874

 

 

 

 

86,724,658

 

 

$

802,449

 

 

$

113,169

 

 

$

(47

)

 

$

(884,624

)

 

$

30,947

 

The accompanying notes are an integral part of the unaudited consolidated financial statements.

7


WAVE LIFE SCIENCES LTD.

UNAUDITED CONSOLIDATED STATEMENTS OF SERIES A PREFERRED SHARES AND SHAREHOLDERS’ EQUITY (DEFICIT) CONTINUED

(In thousands, except share amounts)

 

 

Series A
Preferred Shares

 

 

 

Ordinary Shares

 

 

Additional
Paid-In-

 

 

Accumulated
Other
Comprehensive

 

 

Accumulated

 

 

Total
Shareholders’

 

 

 

Shares

 

 

Amount

 

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Income (Loss)

 

 

Deficit

 

 

Equity (Deficit)

 

Balance at December 31, 2022

 

 

3,901,348

 

 

$

7,874

 

 

 

 

86,924,643

 

 

$

802,833

 

 

$

119,442

 

 

$

(29

)

 

$

(967,337

)

 

$

(45,091

)

Issuance of ordinary shares

 

 

 

 

 

 

 

 

 

10,683,761

 

 

 

34,623

 

 

 

 

 

 

 

 

 

 

 

 

34,623

 

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,750

 

 

 

 

 

 

 

 

 

2,750

 

Vesting of RSUs

 

 

 

 

 

 

 

 

 

363,161

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Option exercises

 

 

 

 

 

 

 

 

 

181

 

 

 

1

 

 

 

 

 

 

 

 

 

 

 

 

1

 

Issuance of ordinary shares
   under the ESPP

 

 

 

 

 

 

 

 

 

133,098

 

 

 

429

 

 

 

 

 

 

 

 

 

 

 

 

429

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(21

)

 

 

 

 

 

(21

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(27,405

)

 

 

(27,405

)

Balance at March 31, 2023

 

 

3,901,348

 

 

$

7,874

 

 

 

 

98,104,844

 

 

$

837,886

 

 

$

122,192

 

 

$

(50

)

 

$

(994,742

)

 

$

(34,714

)

Issuance of ordinary shares
   pursuant to the at-the-market
   equity program, net

 

 

 

 

 

 

 

 

 

429,051

 

 

 

1,704

 

 

 

 

 

 

 

 

 

 

 

 

1,704

 

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,409

 

 

 

 

 

 

 

 

 

2,409

 

Vesting of RSUs

 

 

 

 

 

 

 

 

 

9,234

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Option exercises

 

 

 

 

 

 

 

 

 

23,687

 

 

 

85

 

 

 

 

 

 

 

 

 

 

 

 

85

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(100

)

 

 

 

 

 

(100

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(21,104

)

 

 

(21,104

)

Balance at June 30, 2023

 

 

3,901,348

 

 

$

7,874

 

 

 

 

98,566,816

 

 

$

839,675

 

 

$

124,601

 

 

$

(150

)

 

$

(1,015,846

)

 

$

(51,720

)

The accompanying notes are an integral part of the unaudited consolidated financial statements.

8


WAVE LIFE SCIENCES LTD.

UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

 

 

Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

Cash flows from operating activities

 

 

 

 

 

 

Net loss

 

$

(48,509

)

 

$

(79,110

)

Adjustments to reconcile net loss to net cash provided by (used in) operating activities:

 

Amortization of right-of-use assets

 

 

2,038

 

 

 

1,593

 

Depreciation of property and equipment

 

 

2,722

 

 

 

3,425

 

Share-based compensation expense

 

 

5,159

 

 

 

10,921

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses

 

 

(1,080

)

 

 

1,188

 

Other assets

 

 

(2,373

)

 

 

(1,946

)

Accounts payable

 

 

(4,456

)

 

 

3,264

 

Accrued expenses and other current liabilities

 

 

(7,123

)

 

 

(3,776

)

Deferred revenue

 

 

104,341

 

 

 

(1,855

)

Operating lease liabilities

 

 

(2,454

)

 

 

(2,399

)

Net cash provided by (used in) operating activities

 

 

48,265

 

 

 

(68,695

)

Cash flows from investing activities

 

 

 

 

 

 

Purchases of property and equipment

 

 

(561

)

 

 

(700

)

Proceeds from the sale property and equipment

 

 

 

 

 

106

 

Purchase of short-term investments

 

 

 

 

 

(50,000

)

Proceeds from maturity of short-term investments

 

 

 

 

 

25,000

 

Net cash used in investing activities

 

 

(561

)

 

 

(25,594

)

Cash flows from financing activities

 

 

 

 

 

 

Proceeds from issuance of ordinary shares, net of offering costs

 

 

34,623

 

 

 

51,464

 

Proceeds from issuance of pre-funded warrants, net of offering costs

 

 

 

 

 

14,336

 

Proceeds from issuance of ordinary shares pursuant to the
   at-the-market equity program, net of offering costs

 

 

1,764

 

 

 

1,105

 

Proceeds from the exercise of share options

 

 

86

 

 

 

37

 

Proceeds from the ESPP

 

 

429

 

 

 

174

 

Net cash provided by financing activities

 

 

36,902

 

 

 

67,116

 

Effect of foreign exchange rates on cash, cash equivalents and restricted cash

 

 

(121

)

 

 

(228

)

Net increase (decrease) in cash, cash equivalents and restricted cash

 

 

84,485

 

 

 

(27,401

)

Cash, cash equivalents and restricted cash, beginning of period

 

 

92,157

 

 

 

154,215

 

Cash, cash equivalents and restricted cash, end of period

 

$

176,642

 

 

$

126,814

 

Supplemental disclosure of cash flow information

 

 

 

 

 

 

Increase in operating lease right-of-use assets and
   lease liabilities related to lease extension

 

$

 

 

$

12,006

 

Offering costs in accounts payable at period end

 

$

60

 

 

$

311

 

The accompanying notes are an integral part of the unaudited consolidated financial statements.

9


Wave Life Sciences Ltd.

Notes to Unaudited Consolidated Financial Statements

1. THE COMPANY

Organization

Wave Life Sciences Ltd. (together with its subsidiaries, “Wave” or the “Company”) is a biotechnologyclinical-stage RNA medicines company with an innovativecommitted to delivering life-changing treatments for people battling devastating diseases. Using PRISM, Wave’s proprietary discovery and proprietary synthetic chemistry drug development platform that we are usingenables the precise design, optimization, and production of novel stereopure oligonucleotides, Wave is working to develop best- or first-in-class medicines that target the transcriptome (the full set of ribonucleic acid (“RNA”) molecules produced from the human genome) to treat genetically defined diseases with a high degree of unmet need.

The Company was incorporated in Singapore on July 23, 2012 and has its principal U.S. office in Cambridge, Massachusetts. The Company was incorporated with the purpose of combining two commonly held companies, Wave Life Sciences USA, Inc. (“Wave USA”), a Delaware corporation (formerly Ontorii, Inc.), and Wave Life Sciences Japan, Inc. (“Wave Japan”), a company organized under the laws of Japan (formerly Chiralgen., Ltd.), which occurred on September 13, 2012. On May 31, 2016, Wave Life Sciences Ireland Limited (“Wave Ireland”) was formed as a wholly-owned subsidiary of Wave Life Sciences Ltd. On April 3, 2017, Wave Life Sciences UK Limited (“Wave UK”) was formed as a wholly-owned subsidiary of Wave Life Sciences Ltd.

The Company’s primary activities since inception have been developing and evolving PRISM to design, develop and commercialize oligonucleotide therapeutics, advancing the Company’s differentiated portfolio, building the Company’s research, development and manufacturing capabilities, advancing programs into the clinic, furthering clinical development of such clinical-stage programs, building the Company’s intellectual property, and assuring adequate capital to support these activities.

Liquidity

Since its inception, the Company has not generated any product revenue and has incurred recurring net losses. To date, the Company has primarily funded its operations through private placements of debt and equity securities, public and other registered offerings of its equity securities and collaborations with third parties. Until the Company can generate significant revenue from product sales, if ever, the Company expects to continue to finance operations through a broad pipelinecombination of public or private equity or debt financings or other sources, which may include collaborations with third parties. Adequate additional financing may not be available to the Company on acceptable terms, or at all. The inability to raise capital as and when needed would have a negative impact on the Company’s financial condition and ability to pursue its business strategy.

As of June 30, 2023, the Company had cash and cash equivalents of $173.0 million. The Company expects that its existing cash and cash equivalents will be sufficient to fund its operations for at least the next twelve months. The Company has based this expectation on assumptions that may prove to be incorrect, and the Company may use its available capital resources sooner than it currently expects. If the Company’s anticipated operating results are not achieved in future periods, planned expenditures may need to be further reduced in order to extend the time period over which the then-available resources would be able to fund the Company’s operations. In addition, the Company may elect to raise additional funds before it needs them if the conditions for raising capital are favorable due to market conditions or strategic considerations, even if the Company expects it has sufficient funds for its current or future operating plans.

Risks and Uncertainties

The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, maintaining internal manufacturing capabilities, dependence on key personnel, compliance with government regulations and the need to obtain additional financing. The Company’s therapeutic programs will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to commercialization of any product candidates. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance-reporting capabilities. There can be no assurance that the Company’s research and development efforts will be successful, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapid change in technology and substantial competition from pharmaceutical and biotechnology companies.

10


Basis of Presentation

The Company has prepared the accompanying consolidated financial statements in conformity with generally accepted accounting principles in the United States (“U.S. GAAP”) and in U.S. dollars.

2. SIGNIFICANT ACCOUNTING POLICIES

The significant accounting policies described in the Company’s audited financial statements as of and for the year ended December 31, 2022, and the notes thereto, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 23, 2023, as amended (the “2022 Annual Report on Form 10-K”), have had no material changes during the six months ended June 30, 2023, except as described below.

Use of Estimates

The Company’s consolidated financial statements are prepared in accordance with U.S. GAAP. The preparation of the Company’s financial statements and related disclosures requires the Company to make estimates and assumptions that affect the reported amount of assets, liabilities, revenue, costs and expenses and related disclosures. Management considers many factors in selecting appropriate financial accounting policies and in developing the estimates and assumptions that are used in the preparation of the financial statements. Management must apply significant judgment in this process. The Company believes that its revenue recognition policy, particularly (a) assessing the number of performance obligations; (b) determining the transaction price; (c) allocating the transaction price to the performance obligations in the contract; and (d) determining the pattern over which performance obligations are satisfied, including estimates to complete performance obligations, and the assumptions and estimates used in the Company’s analysis of contracts with contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”) to estimate the contract expense, involve a greater degree of judgment, and therefore the Company considers them to be its critical accounting policies. The Company evaluates its estimates and assumptions on an ongoing basis. The Company’s actual results may differ from these estimates under different assumptions and conditions.

Unaudited Interim Financial Data

The accompanying interim consolidated balance sheet as of June 30, 2023, the related interim consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2023 and 2022, the consolidated statements of Series A preferred shares and shareholders’ equity (deficit) for the three months ended March 31, June 30, 2023 and 2022, the consolidated statements of cash flows for the six months ended June 30, 2023 and 2022, and the related interim information contained within the notes to the unaudited consolidated financial statements have been prepared in accordance with the rules and regulations of the SEC for interim financial information. Accordingly, they do not include all of the information and the notes required by U.S. GAAP for complete financial statements. The financial data and other information disclosed in these notes related to the three and six months ended June 30, 2023 and 2022 are unaudited. In the opinion of management, the unaudited interim consolidated financial statements reflect all adjustments, consisting of normal and recurring adjustments, necessary for the fair presentation of the Company’s financial position and results of operations for the three and six months ended June 30, 2023 and 2022. The results of operations for the interim periods are not necessarily indicative of the results to be expected for the year ending December 31, 2023 or any other interim period or future year or period.

3. ACCRUED EXPENSES AND OTHER CURRENT LIABILITIES

Accrued expenses and other current liabilities consist of the following:

 

 

June 30, 2023

 

 

December 31, 2022

 

 

 

(in thousands)

 

Accrued compensation

 

$

6,898

 

 

$

12,287

 

Accrued expenses related to CROs and CMOs

 

 

2,662

 

 

 

3,516

 

Accrued expenses and other current liabilities

 

 

869

 

 

 

1,749

 

Total accrued expenses and other current liabilities

 

$

10,429

 

 

$

17,552

 

11


4. SHARE-BASED COMPENSATION

The Wave Life Sciences Ltd. 2021 Equity Incentive Plan was approved by the Company’s shareholders and went into effect on August 10, 2021 and was amended effective as of August 9, 2022 (as amended, the “2021 Plan”). The 2021 Plan serves as the successor to the Wave Life Sciences Ltd. 2014 Equity Incentive Plan, as amended (the “2014 Plan”), such that outstanding awards granted under the 2014 Plan continue to be governed by the terms of the 2014 Plan, but no awards may be made under the 2014 Plan after August 10, 2021. The aggregate number of ordinary shares authorized for issuance of awards under the 2021 Plan was originally 5,450,000 ordinary shares, and was subsequently increased to 11,450,000 in August 2022, plus the number of ordinary shares underlying any awards under the 2014 Plan that are forfeited, cancelled or otherwise terminated (other than by exercise or withheld by the Company to satisfy any tax withholding obligation) on or after August 10, 2021.

The 2021 Plan authorizes (and the 2014 Plan previously authorized) the board of directors or a committee of the board of directors to, among other things, grant non-qualified share options, restricted awards, which include restricted shares and restricted share units (“RSUs”), and performance awards to eligible employees and directors of the Company. The Company accounts for grants to its non-employee directors as grants to employees.

Options generally vest over periods of one to four years, and options that are forfeited or cancelled are available to be granted again. The contractual life of options is generally five or ten years from the grant date. RSUs can be time-based or performance-based. Time-based RSUs generally vest over a period of one to four years. The vesting of performance-based RSUs is contingent on the achievement of certain performance milestones. Any RSUs that are forfeited are available to be granted again.

During the six months ended June 30, 2023, the Company granted an aggregate of 4,984,750 options and 101,700 time-based RSUs to employees.

As of June 30, 2023, 1,756,326 ordinary shares remained available for future grant under the 2021 Plan.

The Wave Life Sciences Ltd. 2019 Employee Share Purchase Plan (“ESPP”) allows full-time and certain part-time employees to purchase the Company’s ordinary shares at a discount to fair market value. Eligible employees may enroll in a six-month offering period beginning every January 15th and July 15th. Ordinary shares are purchased at a price equal to 85% of the lower of the fair market value of the Company’s ordinary shares on the first business day or the last business day of an offering period. During the six months ended June 30, 2023, 133,098 ordinary shares were issued under the ESPP. As of June 30, 2023, there were 583,315 ordinary shares available for issuance under the ESPP.

5. COLLABORATION AGREEMENTS

GSK Collaboration and Equity Agreements

On December 13, 2022, Wave USA and Wave UK entered into a Collaboration and License Agreement (the “GSK Collaboration Agreement”) with GlaxoSmithKline Intellectual Property (No. 3) (“GSK”). Pursuant to the GSK Collaboration Agreement, Wave and GSK have agreed to collaborate on the research, development, and commercialization of oligonucleotide therapeutics, including an exclusive global license to WVE-006. The discovery collaboration component has an initial four-year research term and combines Wave’s proprietary discovery and drug development platform, PRISM, with GSK’s unique insights from human genetics and its global development and commercial capabilities. On January 27, 2023, the GSK Collaboration Agreement became effective, and GSK paid Wave an upfront payment of $120.0 million.

Simultaneously with the execution of the GSK Collaboration Agreement, Wave entered into a Share Purchase Agreement (the “SPA”) on December 13, 2022, with Glaxo Group Limited (“GGL”), an affiliate of GSK, pursuant to which Wave agreed to sell 10,683,761 of its ordinary shares to GGL at a purchase price of $4.68 per share (the “GSK Equity Investment”). The GSK Equity Investment closed on January 26, 2023, following the completion of customary closing conditions. The ordinary shares purchased by GGL are subject to lock-up and standstill restrictions and carry certain registration rights, customary for transactions of this kind. The Company did not incur any material costs in connection with the issuance of the ordinary shares under the SPA.

The GSK Collaboration Agreement has three components:

1.
An exclusive global license for GSK to WVE-006, the Company’s preclinical, first-in-class A-to-I(G) RNA editing candidate for alpha-1 antitrypsin deficiency, with development and commercialization responsibilities transferring to GSK after the Company completes the first-in-patient study (the “AATD Collaboration”). The Company will be responsible for preclinical, regulatory, manufacturing, and clinical activities for WVE-006 through the initial Phase 1/2 study, at the Company’s sole cost. Thereafter, GSK will be responsible for advancing WVE-006 through pivotal studies, registration, and global commercialization at GSK’s sole cost;
2.
A discovery research collaboration which enables GSK to advance up to eight programs leveraging PRISM and the Company’s oligonucleotide expertise and discovery capabilities (the “Discovery Research Collaboration”); and
3.
A discovery collaboration which enables the Company to advance up to three programs leveraging targets informed by GSK’s novel insights (“Wave’s Collaboration Programs”).

12


Under the GSK Collaboration Agreement, each party grants to the other party certain licenses to the collaboration products to enable the other party to perform its obligations and exercise its rights under the GSK Collaboration Agreement, including license grants to enable each party to conduct research, development and commercialization activities pursuant to the terms of the GSK Collaboration Agreement. The parties’ exclusivity obligations to each other are limited on a target-by-target basis with regard to targets in the collaboration. GSK may terminate the GSK Collaboration Agreement for convenience, in its entirety or on a target-by-target basis. Subject to certain exceptions, each party has the right to terminate the GSK Collaboration Agreement on a target-by-target basis if the other party, or a related party, challenges the patentability, enforceability or validity of any patents within the licensed technology that cover any product that is subject to the GSK Collaboration Agreement. In the event of any material breach of the GSK Collaboration Agreement by a party, subject to cure rights, the other party may terminate the GSK Collaboration Agreement in its entirety if the breach relates to all targets or on a target-by-target basis if the breach relates to a specific target. In the event that GSK and its affiliates cease development, manufacturing and commercialization activities with respect to compounds or products subject to the GSK Collaboration Agreement and directed to a particular target, the Company may terminate the GSK Collaboration Agreement with respect to such target. Either party may terminate the GSK Collaboration Agreement for the other party’s insolvency. In certain termination circumstances, the Company would receive a license from GSK to continue researching, developing and manufacturing certain products.

The GSK Collaboration Agreement, unless terminated earlier, will continue until the date on which: (i) with respect to a validation target, the date on which such validation target is not advanced into a collaboration program; or (ii) with respect to a collaboration target, the royalty term has expired for all collaboration products directed to the applicable collaboration target. The GSK Collaboration Agreement includes options to extend the research term for up to three additional years, which would increase the number of programs available to both parties. The Company will lead all preclinical research for GSK and the Company’s collaboration programs up to investigational new drug (“IND”)-enabling studies. The Company will lead IND-enabling studies, clinical development and commercialization for the Company’s collaboration programs. GSK collaboration programs will transfer to GSK for IND-enabling studies, clinical development and commercialization.

The GSK Collaboration Agreement is managed by a joint steering committee in which both parties are represented equally. In addition, the AATD Collaboration is overseen by a joint development committee, a joint patent committee advises on intellectual property activities, and the Discovery Research Collaboration is overseen by a joint research committee. Both parties are represented equally for these committees and report to the joint steering committee.

The Company assessed this arrangement in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”) and concluded that the contract counterparty, GSK, is a customer for the AATD Collaboration prior to GSK exercising its option and, for the Discovery Research Collaboration programs during the target validation research term. The Company identified the following material promises under the arrangement: (1) the exclusive global license for WVE-006; (2) the research and development services for WVE-006 through the Phase 1/2 study; (3) the discovery research services under the Discovery Research Collaboration to perform target validation programs; (4) research and development license for the Discovery Research Collaboration; and (5) the research and development services for the GSK collaboration programs through completion of a candidate selection. The research and development services for WVE-006 were determined to not be distinct from the exclusive global license and should therefore be combined into a single performance obligation for the AATD Collaboration. The research and development services for the Discovery Research Collaboration were determined to not be distinct from the research and development license for the Discovery Research Collaboration and should therefore be combined into a single performance obligation. In addition, the Company determined that the option to advance up to eight programs from the Discovery Research Collaboration was priced at fair value and did not provide a material right to GSK.

Based on these assessments, the Company identified two performance obligations in the GSK Collaboration Agreement: (1) AATD Collaboration consisting of the research and development services through completion of the Phase 1/2 study and research and development license for WVE-006 and (2) Discovery Research Collaboration which consists of research and development services for validating the targets and license for research and development license for targets.

At the outset of the arrangement, the transaction price included fixed consideration of the $120.0 million upfront, the $15.4 million in premium related to the GSK Equity Investment and the estimated variable consideration related to the additional target validation research funding. The Company allocated the estimated variable consideration to the Discovery Research Collaboration programs and then allocated the fixed consideration to the performance obligations on a relative standalone selling price basis. The Company determined that the GSK Collaboration Agreement did not contain a significant financing component. The program initiation fees to research and preclinically develop the GSK collaboration programs and the additional potential milestone payments were excluded from the transaction price, as all milestone amounts were fully constrained at the inception of the GSK Collaboration Agreement. The Company will reevaluate the transaction price at the end of each reporting period, and as uncertain events are resolved or other changes in circumstances occur, the Company will adjust its estimate of the transaction price.

13


The Company developed the estimated standalone selling price for the global license for WVE-006, under the AATD Collaboration, using a discounted cash flow model. For the performance obligation associated with the research and development services under the Discovery Research Collaboration and the research and development services for WVE-006 under the AATD Collaboration, the Company determined the standalone selling price using estimates of the costs to perform the research and development services, including expected internal and external costs for services and supplies, adjusted to reflect a profit margin. The total estimated cost of the research and development services reflected the nature of the services to be performed and the Company’s best estimate of the length of time required to perform the services.

Revenue associated with the AATD Collaboration performance obligation is being recognized as the research and development services are provided using an input measure, according to the costs incurred and the total costs expected to be incurred to satisfy the performance obligation. The revenue associated with the Discovery Research Collaboration performance obligation is being recognized as the research and development services are provided using an input measure, according to the costs incurred and the total costs expected to be incurred to satisfy the performance obligation. The amounts received that have not yet been recognized as revenue are recorded in deferred revenue on the Company’s consolidated balance sheet. Additional funding related to the Company’s research activities related to Discovery Research Collaboration will be recorded as accounts receivable when contractually enforceable and recorded as deferred revenue, or as revenue as the services are provided.

During the three and six months ended June 30, 2023, the Company recognized revenue of approximately $20.8 million and $33.1 million, respectively, under the GSK Collaboration Agreement using the input method described above.

The aggregate amount of the transaction price allocated to the Company’s unsatisfied and partially unsatisfied performance obligations and recorded in deferred revenue on June 30, 2023 is approximately $106.3 million, of which $81.2 million is included in current liabilities and $25.1 million is included in long-term liabilities.

Takeda Collaboration and Equity Agreements

In February 2018, Wave USA and Wave UK entered into a global strategic collaboration (the “Takeda Collaboration”) 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 provides the Company with at least $230.0 million in committed cash and Takeda with the option to co-develop and co-commercialize the Company’s CNS development programs in (1) Huntington’s disease (“HD”); (2) amyotrophic lateral sclerosis (“ALS”) and frontotemporal dementia (“FTD”); and (3) the Company’s discovery-stage program targeting ATXN3 for the treatment of spinocerebellar ataxia 3 (“SCA3”) (collectively, “Category 1 Programs”). In addition, the Takeda Collaboration provided Takeda 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 became effective and Takeda paid the Company $110.0 million as an upfront payment. Takeda also agreed to fund the Company’s research and preclinical activities in the amount of $60.0 million during the four-year research term and to reimburse the Company 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 collaboration and license agreement with Takeda (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 Takeda Equity Agreement and received aggregate cash proceeds of $60.0 million. The Company did not incur any material costs in connection with the issuance of the shares.

With respect to Category 1 Programs, the Company will be responsible for researching and developing products and companion diagnostics for Category 1 Programs through completion of the first proof of mechanism study 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 the proof of mechanism study. If Takeda exercises this option, the Company 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 the Company will be eligible to receive development and commercial milestone payments. In addition to its 50% profit share, the Company is eligible to receive option exercise fees and development and commercial milestone payments for each of the Category 1 Programs.

14


With respect to Category 2 Programs, the Company 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 Takeda Collaboration provided that the parties may collaborate on preclinical programs for up to six targets at any one time. The Company was responsible for researching and preclinically developing products and companion diagnostics directed to the agreed upon targets through completion of Investigational New Drug application (“IND”)-enabling studies in the first major market country. Thereafter, Takeda would have an exclusive worldwide license to develop and commercialize products and companion diagnostics directed to such targets, subject to the Company’s retained rights to lead manufacturing activities for products directed to such targets. Takeda agreed to fund the Company’s research and preclinical activities in the amount of $60.0 million during the research term and reimburse the Company for any collaboration-budgeted research and preclinical expenses incurred by the Company that exceeded that amount. The Company was 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.

Under the Takeda Collaboration Agreement, each party granted to the other party specific intellectual property licenses to enable the other party to perform its obligations and exercise its rights under the Takeda Collaboration Agreement, including license grants to enable each party to conduct research, development and commercialization activities pursuant to the terms of the Takeda Collaboration Agreement.

The term of the Takeda Collaboration Agreement commenced on April 2, 2018 and, unless terminated earlier, will continue until the date on which: (i) with respect to each Category 1 Program target for which Takeda does not exercise its option, the expiration or termination of the development program with respect to such target; (ii) with respect to each Category 1 Program target for which Takeda exercises its option, the date on which neither party is researching, developing or manufacturing any products or companion diagnostics directed to such target; or (iii) with respect to each Category 2 Program target, the date on which royalties are no longer payable with respect to products directed to such target.

Takeda may terminate the Takeda Collaboration Agreement for convenience on 180 days’ notice, in its entirety or on a target-by-target basis. Subject to certain exceptions, each party has the right to terminate the Takeda Collaboration Agreement on a target-by-target basis if the other party, or a third party related to such party, challenges the patentability, enforceability or validity of any patents within the licensed technology that cover any product or companion diagnostic that is subject to the Takeda Collaboration Agreement. In the event of any material breach of the Takeda Collaboration Agreement by a party, subject to cure rights, the other party may terminate the Takeda Collaboration Agreement in its entirety if the breach relates to all targets or on a target-by-target basis if the breach relates to a specific target. In the event that Takeda and its affiliates cease development, manufacturing and commercialization activities with respect to compounds or products subject to the Takeda Collaboration Agreement and directed to a particular target, the Company may terminate the Takeda Collaboration Agreement with respect to such target. Either party may terminate the Takeda Collaboration Agreement for the other party’s insolvency. In certain termination circumstances, the Company would receive a license from Takeda to continue researching, developing and manufacturing certain products, and companion diagnostics.

The Takeda Collaboration is managed by a joint steering committee in which both parties are represented equally. The joint steering committee is tasked with overseeing the scientific progression of each Category 1 Program and, prior to the Amendment (discussed below), the Category 2 Programs.

The Company assessed this arrangement in accordance with ASC 606 and concluded that the contract counterparty, Takeda, is a customer for Category 1 Programs prior to Takeda exercising its option, and for Category 2 Programs during the Category 2 Research Term. The Company identified the following material promises under the arrangement: (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 completion of the first proof of mechanism study; (3) the exclusive option to license, co-develop and co-commercialize each Category 1 Program; (4) the right to exclusively license the Category 2 Programs; and (5) 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 to not be distinct from the research and development license and should therefore be combined into a single performance obligation for each Category 1 Program. The research and preclinical development services for the Category 2 Programs were determined to not be distinct from the exclusive licenses for the Category 2 Programs and therefore were combined into a single performance obligation.

Additionally, the Company determined that the exclusive option for each Category 1 Program was priced at a discount, and, as such, provide material rights to Takeda, representing three separate performance obligations. Based on these assessments, the Company identified seven performance obligations in the Takeda Collaboration Agreement: (1) research and development services through completion of the first proof of mechanism and non-exclusive research and development license for HD; (2) research and development services through completion of the first proof of mechanism and non-exclusive research and development license for ALS and FTD; (3) research and development services through completion of the first proof of mechanism 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.

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At the outset of the arrangement, the transaction price included the $110.0 million upfront consideration received and the $60.0 million of committed research and preclinical funding for the Category 2 Programs. The Company determined that the Takeda Collaboration Agreement did not contain a significant financing component. The option exercise fees to license, co-develop and co-commercialize each Category 1 Program that may be received are excluded from the transaction price until each customer option is exercised. The potential milestone payments were excluded from the transaction price, as all milestone amounts were fully constrained at the inception of the Takeda Collaboration Agreement. The Company will reevaluate the transaction price at the end of each reporting period and as uncertain events are resolved or other changes in circumstances occur, if necessary, will adjust its estimate of the transaction price.

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 first proof of mechanism and non-exclusive research and development license for SCA3; and the research and preclinical development services and right to exclusively license the Category 2 Programs, the Company determined the standalone selling price using estimates of the costs to perform the research and development services, including expected internal and external costs for services and supplies, adjusted to reflect a profit margin. The total estimated cost of the research and development services reflected the nature of the services to be performed and the Company’s best estimate of the length of time required to perform the services. For the performance obligations associated with 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; and the material right provided for the exclusive option to license, co-develop and co-commercialize SCA3, the Company estimated the standalone fair value of the option to license each Category 1 Program utilizing an adjusted market assessment approach, and determined that any standalone fair value in excess of the amounts to be paid by Takeda associated with each option represented a material right.

Revenue associated with the research and development services for each Category 1 Program performance obligation is being recognized as the research and development services are provided using an input method, according to the costs incurred on each Category 1 Program and the total costs expected to be incurred to satisfy each Category 1 Program performance obligation. Prior to the Amendment (as defined below), revenue associated with the research and preclinical development services for the Category 2 Programs performance obligation was recognized as the research and preclinical development services are provided using an input method, according to the costs incurred on Category 2 Programs and the total costs expected to be incurred to satisfy the performance obligation. The amount allocated to the material right for each Category 1 Program option will be recognized on the date that Takeda exercises each respective option, or immediately as each option expires unexercised. The amounts received that have not yet been recognized as revenue are recorded in deferred revenue on the Company’s consolidated balance sheet.

On October 15, 2021, Wave USA, Wave UK and Takeda entered into the Second Amendment to the Takeda Collaboration Agreement (the “Amendment”), which discontinued the Category 2 component of the Takeda Collaboration. The Category 1 Programs under the Collaboration Agreement remain in effect and are unchanged by the Amendment. Pursuant to the Amendment, Takeda agreed to pay the Company an additional $22.5 million as full payment for reimbursable Category 2 Programs collaboration-budgeted research and preclinical expenses. The Company received this payment from Takeda related to the Category 2 component and recognized the full amount as collaboration revenue in the year ended December 31, 2021.

Through June 30, 2023, the Company had recognized revenue of $83.2 million as collaboration revenue under the Takeda Collaboration Agreement in the Company’s consolidated statements of operations and comprehensive loss. During the three and six months ended June 30, 2023, the Company recognized revenue of $1.3 million and $2.0 million under the Takeda Collaboration Agreement, respectively. During the three and six months ended June 30, 2022, the Company recognized revenue of approximately $0.3 million and $1.9 million under the Takeda Collaboration Agreement, respectively.

The aggregate amount of the transaction price allocated to the Company’s unsatisfied and partially unsatisfied performance obligations and recorded in deferred revenue as of December 31, 2022 was $111.3 million, of which approximately $31.6 million was included in current liabilities and $79.8 million was included in long-term liabilities. The aggregate amount of the transaction price allocated to the Company’s unsatisfied and partially unsatisfied performance obligations and recorded in deferred revenue at June 30, 2023 is $109.3 million, of which $29.9 million is included in current liabilities and $79.4 million is included in long-term liabilities. The Company expects to recognize revenue for the portion of the deferred revenue that relates to the research and development services for each Category 1 Program as costs are incurred, over the remaining research term. The Company expects to recognize revenue for the portion of the deferred revenue that relates to the material right for each Category 1 Program option upon Takeda’s exercise or termination of such option, or immediately as each option expires unexercised.

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6. NET LOSS PER ORDINARY SHARE

The Company applies the two-class method to calculate its basic and diluted net loss per share attributable to ordinary shareholders, as its Series A preferred shares are participating securities. The two-class method is an earnings allocation formula that treats a participating security as having rights to earnings that otherwise would have been available to ordinary shareholders.

As of June 30, 2023, there are 7,093,656 vested and exercisable pre-funded warrants (“Pre-Funded Warrants”) outstanding to purchase ordinary shares for the exercise price of $0.0001 per share, provided that, unless and until the Company obtains shareholder approval for the issuance of the shares underlying the Pre-Funded Warrants, a holder will not be entitled to exercise any portion of any Pre-Funded Warrant, which, upon giving effect to such exercise, would cause (i) the aggregate number of our ordinary shares beneficially owned by the holder (together with its affiliates) to exceed 19.99% of the number of our ordinary shares outstanding immediately after giving effect to the exercise, or (ii) the combined voting power of our securities beneficially owned by the holder (together with its affiliates) to exceed 19.99% of the combined voting power of all of our securities then outstanding immediately after giving effect to the exercise, as such percentage ownership is determined in accordance with the terms of the Pre-Funded Warrants. The Pre-Funded Warrants are included in the weighted-average shares outstanding used in the calculation of basic net loss per share as the exercise price is negligible and the warrants are fully vested and exercisable.

Basic loss per share is computed by dividing net loss attributable to ordinary shareholders and Pre-Funded Warrant holders by the weighted-average number of ordinary shares and Pre-Funded Warrants outstanding.

The Company’s potentially dilutive shares, which include outstanding share options to purchase ordinary shares, RSUs, and Series A preferred shares, are considered to be ordinary share equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive.

The following potential ordinary shares, presented based on amounts outstanding at each period end, were excluded from the calculation of diluted net loss per share attributable to ordinary shareholders for the periods indicated because including them would have had an anti-dilutive effect:

 

 

As of June 30,

 

 

 

2023

 

 

2022

 

Options to purchase ordinary shares

 

 

14,176,822

 

 

 

8,526,312

 

RSUs

 

 

626,465

 

 

 

979,850

 

Series A preferred shares

 

 

3,901,348

 

 

 

3,901,348

 

Additionally, for the periods presented, the two-class method does not impact the net loss per ordinary share as the Company was in a net loss position for each of the periods presented and holders of Series A preferred shares do not participate in losses.

7. INCOME TAXES

During the three and six months ended June 30, 2023 and 2022, the Company recorded no income tax provision. The Company maintained a full valuation allowance for the three and six months ended June 30, 2023 and 2022 in all jurisdictions due to uncertainty regarding future taxable income.

8. GEOGRAPHIC DATA

Substantially all of the Company’s long-lived assets were located in the United States as of June 30, 2023 and December 31, 2022.

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9. RELATED PARTY TRANSACTIONS

The Company had the following related party transactions:

In 2012, the Company entered into a consulting agreement for scientific advisory services with Dr. Gregory L. Verdine, one of the Company’s founders and a member of the Company’s board of directors. The consulting agreement does not have a specific term and may be terminated by either party upon 14 days’ prior written notice. Pursuant to the consulting agreement, the Company pays Dr. Verdine approximately $13 thousand per month, plus reimbursement for certain expenses. In October 2022, the compensation committee of the Company’s board of directors granted Dr. Verdine a non-qualified share option for 163,467 ordinary shares in lieu of cash as payment under this consulting agreement for the service period of October 1, 2022 through December 31, 2024, the monthly vesting of which is subject to Dr. Verdine’s continued service under the consulting agreement.
In April 2023, the Company engaged Shin Nippon Biomedical Laboratories Ltd. (“SNBL”), one of the Company’s shareholders, to provide approximately $2.8 million in certain non-human primate contract research services to the Company and during the three months ended June 30, 2023, the Company paid SNBL $1.4 million for the aforementioned contract research services.

10. SUBSEQUENT EVENT

In May 2023, the Company announced its decision to discontinue clinical development of WVE-004 for C9orf72-associated ALS and FTD (“C9-ALS/FTD”). In July 2023, the joint steering committee that manages the Takeda Collaboration terminated C9-ALS/FTD as a target under the collaboration (the “C9 Target”) and consequently Takeda and the Company’s rights and obligations under the Takeda Collaboration were terminated with respect to the C9 Target.

As a result of the termination, the Company will recognize $28.0 million in revenue during the three months ended September 30, 2023, this represents the remainder of the deferred revenue for the C9 Target as of June 30, 2023.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our financial statements and related notes appearing elsewhere in this Quarterly Report on Form 10-Q and in our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 23, 2023, as amended (the “2022 Annual Report on Form 10-K”). Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to our plans and strategy for our business, includes forward-looking statements that involve risks and uncertainties. As a result of many factors, including those factors set forth in the “Risk Factors” section of this Quarterly Report on Form 10-Qand the “Risk Factor” section of our 2022 Annual Report on Form 10-K, our actual results could differ materially from the results described in, or implied by, these forward-looking statements.

Overview

We are a clinical-stage RNA medicines company committed to delivering life-changing treatments for people battling devastating diseases. Using PRISM, our proprietary discovery and drug development platform that enables the precise design, optimization, and production of novel stereopure oligonucleotides, we are working to develop first- or best-in-class medicines that target the transcriptome (the full set of ribonucleic acid (“RNA”) molecules produced from the human genome) to treat genetically defined diseases with a high degree of unmet need.

Our RNA-targeting oligonucleotides are designed to correct disease-causing mutations, modulate protein activity, restore the production of functional proteins or reduce the expression of disease-promoting RNAs or proteins. Data from our ongoing clinical and preclinical studies has demonstrated significant improvements in potency, durability, and distribution for our oligonucleotides designed through PRISM, compared with competitor chemistries. These data support our platform as best-in-class for designing and optimizing RNA-targeting medicines.

Since our inception, we have seen the value of developing RNA-targeting medicines compared to other nucleic acid therapeutic candidates for genetically-defined diseases. Nucleic acid therapeutics, are a growingincluding gene therapy and innovative class of drugs thatDNA editing. By intervening at the RNA level, we have the potential to address diseases that have historically been difficult to treat with small molecule drugsmolecules or biologics.biologics, while retaining the ability to titrate dose, modulate duration of effect, and avoid risk of permanent off-target genetic changes and other challenges associated with DNA editing or gene therapy approaches. Oligonucleotides arehave additional advantages as a therapeutic class, including the ability to access multiple tissue types and the ability to modulate the frequency of dosing to ensure broad distribution within tissues over time. Oligonucleotides also have well-established manufacturing processes and validated test methods based on decades of improvements, as well as established regulatory, access, and reimbursement pathways.

Our approach is based on the scientific insight that the biological machinery necessary to address genetic diseases already exists in human cells and can be harnessed for therapeutic purposes with the right tools. We have built a versatile platform comprised of multiple therapeutic modalities, which provides flexibility to design built-for-purpose molecules that optimally address disease biology. These modalities are RNA base editing, splicing, and silencing, including both RNA interference (“RNAi”) and antisense, all of which incorporate proprietary and novel chemistries to optimize the pharmacological properties of our therapeutic oligonucleotides.

img56420585_0.jpg 

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We have a sequencerobust and diverse pipeline of nucleotidespotential first- or best-in-class programs. Our lead programs are designed to treat genetic diseases, including those in muscle, including Duchenne muscular dystrophy (“DMD”); liver, including alpha-1 antitrypsin deficiency (“AATD”); and the central nervous system (“CNS”), including Huntington’s disease (“HD”). These programs include:

WVE-N531 (splicing), our exon 53 molecule for the treatment of DMD;
WVE-006 (editing), our SERPINA1 molecule for the treatment of AATD; and
WVE-003 (silencing), our mHTT SNP3 molecule for the treatment of HD.

Over the last several years, we have built a leading RNA base editing capability. Our A-to-I RNA base editing oligonucleotides (“AIMers”) enable access to areas of disease biology that are linked togethernot viable for other therapeutic modalities. Our editing capability affords us the dexterity to address both rare diseases, as well as diseases impacting large patient populations.

AIMers are designed to target single bases on an RNA transcript and recruit proteins that exist in the body, called ADAR (adenosine deaminases acting on RNA) enzymes, which naturally possess the ability to change an adenine (A) to an inosine (I), which cells read as guanine (G). This approach enables both the correction of G-to-A point mutations, as well as the modulation of RNA to upregulate protein expression, modify protein-protein interactions, or alter RNA folding and processing. AIMers enable simplified delivery and avoid the risk of permanent changes to the genome and irreversible off-target effects with DNA-targeting approaches. AIMers are short in length, fully chemically modified, and use novel chemistry, including proprietary PN backbone modifications and chiral control, which make them distinct from other ADAR-mediated editing approaches.

Our PRISM platform was built on the recognition that a significant opportunity exists to tune the pharmacological properties of oligonucleotide therapeutics by a backboneleveraging three key features of chemical bonds. Wethese molecules: sequence, chemistry, and stereochemistry. Our unique ability to control stereochemistry provides the resolution necessary to optimize pharmacological profiles and develop and manufacture stereopure oligonucleotides. Stereopure oligonucleotides are initially developing oligonucleotides that target genetic defects to either reduce the expression of disease-promoting proteins or transform the production of dysfunctional mutant proteins into the production of functional proteins.

The nucleic acid therapeutics we are developing are stereopure. A stereopure oligonucleotide is comprised of molecules with atoms precisely and purposefully arranged in three-dimensional orientations at each linkage. We believe controlling the position of the sulfur atom in the phosphorothioate (“PS”) moiety will optimize the pharmacological profile of our therapeutics by maximizing therapeutic effect while minimizing the potential for side effects and safety risks. The stereopure therapies we are developingThese differ from the mixture-based

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nucleic acid therapeutics oligonucleotides currently on the market andor in development by others. OurAdditionally, to mitigate pharmacological risks and potential manufacturing challenges, our approach focuses on designing short, chemically modified oligonucleotides without the need for complex delivery vehicles. We have also established and continue to enhance our internal current good manufacturing practices (“cGMP”) manufacturing capabilities to increase control and visibility of our drug substance supply chain, while continuing to innovate oligonucleotide manufacturing.

PRISM also incorporates our novel, proprietary PN backbone chemistry modifications, which have been shown preclinically and clinically to increase potency, distribution, and durability of effect across our various modalities. PN chemistry is incorporated in all of our current clinical, preclinical studies have demonstrated thatand discovery-stage programs.

In December 2022, we announced a strategic collaboration with GlaxoSmithKline Intellectual Property (No. 3) (“GSK”) to advance transformative oligonucleotide therapeutics, including WVE-006. The collaboration combines GSK’s unique insights in human genetics, as well as its global development and commercial capabilities, with our stereopure nucleic acid therapeutics may achieve superior pharmacologic properties as compared to mixture-based nucleic acid therapeutics. OurPRISM platform is designed toand oligonucleotide expertise. The collaboration will enable us to rationally design, optimizecontinue building a pipeline of first-in-class oligonucleotide-based therapeutics and produce stereopure nucleic acid therapeutics, which were previously thought to be too difficult to make and too expensive to manufacture. Further, our platformunlock new areas of disease biology, as well as realize the full value of WVE-006 as a potential best-in-class treatment for AATD that has the potential to design therapies that use anysimultaneously address both liver and lung manifestations of the major molecular mechanisms employed by nucleic acid therapeutics, including antisense, ribonucleic acid interference (“RNAi”) splicing, and exon skipping.disease.

Our goal is to develop disease-modifying drugs for indications with a high degree of unmet medical need in genetically-defined diseases. We are focused on designing single-stranded nucleic acid therapeutics that can distribute broadly within the human body, allowingThe GSK collaboration has three components:

(1)
A discovery collaboration which enables us to target diseases across multiple organ systems and tissues, through both systemic and local administration. In additionadvance up to our currentthree programs in development, we are also leveraging our platformtargets informed by GSK’s novel insights;
(2)
A discovery collaboration which enables GSK to explore the next generation of stereopure nucleic acid therapeutics that have the potentialadvance up to selectively target certain cell types.

Our core focus for our wholly-owned proprietaryeight programs is neurology, which we broadly define as genetic diseases within the central nervous system and neuromuscular system. We have initiated clinical trials of our two lead programs in Huntington’s disease (“HD”)leveraging PRISM and our leadoligonucleotide expertise and discovery capabilities; and

(3)
An exclusive global license for GSK to WVE-006, our preclinical program in Duchenne muscular dystrophy (“DMD”) targeting exon 51. As a partfor AATD that uses our proprietary AIMer technology. We will maintain development responsibilities for WVE-006 through completion of the first clinical study, at which point development and commercial responsibilities will transition to GSK.

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On May 23, 2023, we announced topline results from the Phase 1b/2a FOCUS-C9 study and our portfolio strategy, we expectdecision to initiate three additionaldiscontinue clinical development programs by the end of 2018, targeting exon 53 in DMD and C9orf72 (chromosome 9 open reading frame 72) inWVE-004 for C9orf72-associated amyotrophic lateral sclerosis (“ALS”) and frontotemporal dementia (“FTD”) (“C9-ALS/FTD”). FurtherResults from the study indicated that WVE-004 was generally safe and well-tolerated across doses of WVE-004, with most adverse events presenting as mild in intensity. Importantly, robust, sustained reductions in poly(GP) dipeptide proteins from baseline were observed in the cerebrospinal fluid (“CSF”), with a maximal mean reduction of 48% (p<0.0001) in the Q12W dose and 50% (p=0.0001) in the Q4W dose of WVE-004, successfully translating preclinical model pharmacodynamic effects to clinical biomarker effects. However, no trends in clinical benefit were observed at 24 weeks, and reductions in poly(GP) were not correlated with stabilization or improvement in functional outcomes. Based on these data, and in the absence of biomarkers reasonably likely to predict clinical outcomes, we discontinued development of WVE-004. In July 2023, the joint steering committee that manages the Takeda Collaboration (as defined in Note 5 in the notes to the unaudited consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q, “Note 5”) terminated C9-ALS/FTD as a target under the collaboration (the “C9 Target”) and consequently Takeda and Wave’s rights and obligations under the Takeda Collaboration were terminated with respect to the C9 Target.

Our Current Programs

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Additional details regarding our lead therapeutic programs are set forth below.

In HD, we have two separate programs, WVE-120101 and WVE-120102, each targeting a different disease-associated single nucleotide polymorphism (“SNP”) within the huntingtin gene: rs362307 (“SNP1”) and rs362331 (“SNP2”). SNPs are naturally occurring variations within a given genetic sequence and in certain instances can be used to distinguish between two related copies of a gene where only one is responsible for causing production of a defective protein which causes disease. It has been shown that by targeting SNP1 or SNP2, the production of disease-causing proteins associated with HD can be reduced. In July 2017, we initiated PRECISION-HD1 and PRECISION-HD2, our two Phase 1b/2a multicenter, randomized, double-blind, placebo-controlled clinical trials that will primarily evaluate the safety and tolerability of single and multiple doses of WVE-120101 and WVE-120102, respectively, administered intrathecally in HD patients.

Duchenne muscular dystrophy (“DMD”)

In DMD, we have developed WVE-210201,are advancing WVE-N531, which targetsis designed to skip exon 51, a region53 within the ribonucleic acid (“RNA”), transcribeddystrophin gene – a therapeutic approach that would address approximately 8-10% of DMD cases. WVE-N531 is designed to cause the cellular splicing machinery to skip over this exon during pre-mRNA processing, which restores the dystrophin mRNA reading frame and enables production of truncated, but functional, dystrophin protein. Exon skipping produces dystrophin from the endogenous dystrophin gene. DMD gene (not micro or mini dystrophin expressed from a vector), under the control of native gene-regulatory elements, resulting in normal expression. WVE-N531 is a genetic disorder caused by mutationsboth our first splicing candidate and our first systemically administered candidate incorporating PN chemistry to be assessed in the dystrophin gene that resultsclinic.

In December 2022 (data cut-off: December 6, 2022), we announced a positive update from Part A of the Phase 1b/2a proof-of-concept study of WVE-N531 in dysfunctional dystrophin protein. In November 2017, we initiated our Phase 1 multicenter, double-blind, placebo-controlled clinical trial to evaluate the safety, tolerability and plasma concentrations of single ascending doses of WVE-210201 administered intravenously inthree boys with DMD patients with gene mutations amenable to exon 5153 skipping. In addition, in September 2017, we announced that our next development program will targetHigh muscle concentrations of WVE-N531 and exon 53 in DMD and is expected to initiate clinical trialsskipping were observed six weeks after initiating biweekly multi-dosing at 10 mg/kg, achieving proof-of-concept in the first quarter of 2019.

In ALSstudy. WVE-N531 also appeared safe and FTD,well-tolerated.

To evaluate dystrophin protein restoration, we are targeting pathological C9orf72 mutations resulting from repeat expansions ininitiating the gene. These expansions are currently known asPhase 2 portion of the largest genetic causeWVE-N531 open-label study (“Part B”), and plan to enroll up to ten boys. Boys will be dosed at 10 mg/kg biweekly, and we plan to assess dystrophin protein after 24 and 48 weeks of familial ALSdosing. The primary endpoint will be dystrophin protein levels, and FTD, accounting for approximately one-thirdthe study will also evaluate pharmacokinetics, functional

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endpoints and one-quarter of patients, respectively. Mutations of C9orf72 are also considered to be a strong genetic risk factor for the more common, non-inherited, sporadic forms of ALSsafety and FTD, both of which are fatal, complex, neurodegenerative disorders.tolerability. We expect to initiate clinical developmentdosing in ALS2023 and FTDto deliver data in 2024. Based on results from this study, we would consider advancing a broader DMD pipeline with PN-modified splicing oligonucleotides for skipping other exons, with the fourth quartergoal of 2018.

In May 2016, we entered intoproviding new treatment options for a collaborationlarger population of boys with Pfizer focused onDMD.

Alpha-1 antitrypsin deficiency (“AATD”)

Our AATD program is the advancement of genetically-defined targets for the treatment of metabolic diseases, bringing together our proprietary drug development platform, across antisense and single-stranded RNAi modalities, along with GalNAc and Pfizer’s hepatic targeting technology for delivery to the liver. The collaboration seeksfirst to leverage our stereochemistry platform across antisensenovel RNA editing capability and RNAi modalitiesuses clinically proven N-acetylgalactosamine (“GalNAc”)-conjugated AIMers with subcutaneous dosing. By correcting the single RNA base mutation that causes a majority of AATD cases with the Pi*ZZ phenotype (approximately 200,000 in the United States and Europe), RNA editing may incorporate GalNAcprovide an ideal approach for increasing circulating levels of wild-type Alpha-1 antitrypsin (“AAT”) protein and Pfizer’s hepatic targeting technology.reducing mutant protein aggregation in the liver, thus simultaneously addressing both the lung and liver manifestations of the disease.

In the third quarter of 2022, we announced WVE-006 as our development candidate for AATD. WVE-006 is first-in-class in AATD and is the most advanced program currently in development using an oligonucleotide to harness an endogenous enzyme for RNA editing. IND-enabling studies are complete, and we expect to submit clinical trial applications (CTAs) in the second half of 2023. Additionally, under the GSK collaboration, GSK received the exclusive global license for WVE-006, with clinical development and commercial responsibilities transitioning to GSK after we complete the first clinical trial. Under the terms of the agreement, Pfizercollaboration, we are eligible to receive up to $525 million in development, launch and sales-related milestones, as well as double-digit tiered royalties as a percentage of net sales up to the high teens, for WVE-006.

Preclinical data show that treatment with WVE-006 resulted in approximately 50% RNA editing of SERPINA1 transcript and approximately 7-fold greater AAT protein levels (well above the predicted protective threshold of 11uM) at 13 weeks in an established AATD mouse model (NSG-PiZ). WVE-006 also led to restoration of approximately 50% wild-type M-AAT protein in serum and a 3-fold increase in neutrophil elastase inhibition activity, indicating that the restored M-AAT protein was functional. Wave’s AATD AIMers are highly specific to SERPINA1 RNA in vitro and in vivo based on transcriptome-wide analyses.

If we are successful in the clinic with WVE-006, we will select,both validate our clinical approach to AATD, as well as validate the feasibility of RNA editing in humans.

Huntington’s disease (“HD”)

In HD, we are currently advancing WVE-003, a stereopure antisense oligonucleotide designed to selectively target an undisclosed single nucleotide polymorphism (“SNP”), “mHTT SNP3”, associated with the disease-causing mutant huntingtin (“mHTT”) mRNA transcript within the Huntingtin(“HTT”) gene. Approximately 40% of the HD population carries SNP3 according to published literature (Carroll et al., Molecular Therapy, 2011).

WVE-003 incorporates our novel PN chemistry, as well as learnings from our first-generation HD programs. Targeting mRNA with SNP3 allows us to lower expression of transcript from the mutant allele, while leaving the healthy transcript relatively intact, thereby preserving wild-type (healthy) huntingtin (“wtHTT”) protein, which is important for neuronal function. Our allele-selective approach may also enable us to address the pre-manifest, or asymptomatic, HD patient population in the future. In preclinical studies, WVE-003 showed dose-dependent and selective reduction of mHTT mRNA in vitro, as well as potent and durable knockdown of mHTT mRNA and protein in vivo in mouse models.

The SELECT-HD trial is a multicenter, randomized, double-blind, placebo-controlled Phase 1b/2a clinical trial to assess the safety and tolerability of intrathecally administered WVE-003 for patients with early manifest HD. Additional objectives include measurement of mHTT and wtHTT protein and exploratory pharmacokinetic, pharmacodynamic, clinical and magnetic resonance imaging (“MRI”) endpoints. The SELECT-HD trial is designed to be adaptive, with dose level and dosing frequency being guided by an independent committee.

In September 2022 (data cut-off: August 29, 2022), we announced a positive update from SELECT-HD driven by the observation of reductions in mHTT protein in cerebrospinal fluid (“CSF”) after study participants received either a single 30 or 60 mg dose of WVE-003. Additionally, wtHTT protein levels appeared consistent with allele-selectivity. Single doses (30 mg, 60 mg, and 90 mg) of WVE-003 appeared generally safe and well-tolerated. Based on the SELECT-HD data, we adapted the trial to expand the single-dose cohorts, the multi-dose portion is underway, and we will advance, upexpect to fiveshare additional single-dose, as well as available multi-dose, biomarker and safety data in the second half of 2023. As previously disclosed, Wave’s mHTT assay vendor experienced a cyber-attack in April 2023. No Wave data or patient samples were impacted by the attack and Wave remains in close contact with the vendor as they address this issue.

Discovery Pipeline

We are advancing new targets from discovery throughacross multiple disease areas, in light of compelling preclinical data indicating our oligonucleotides can distribute to various tissues and cells without complex delivery vehicles. We are also focusing on targets that have been genetically

22


validated and offer biomarkers for target engagement to enable early proof-of-concept in the selectionclinic. We expect this research to result in multiple new programs with first-in-class potential being added to our pipeline over the next several years.

In April 2023, we announced the publication of clinical candidates, at which point Pfizer may electpreclinical data for our novel siRNA formats in the journal of Nucleic Acids Research. The preclinical data demonstrated unprecedented Ago2 loading following administration of single subcutaneous GalNAc-siRNA dose, leading to exclusively licenseimproved potency and durability in vivo versus comparator siRNA formats.

We have also demonstrated the programs and undertake further development and potential commercialization. Twoof our siRNA to silence targets were declared upon initiation of the agreement, including Apolipoprotein C-III.in extra-hepatic tissues. In the thirdfirst quarter of 2016, Pfizer nominated its third target.2023, we announced data from our first in vivo siRNA study in the central nervous system (CNS), where our unconjugated siRNA constructs demonstrated 70-90% APP silencing across six brain regions in mouse CNS at eight weeks, following a single intracerebroventricular (ICV) dose.

Through our collaboration with GSK, we are gaining access to proprietary genetic insights to expand our wholly-owned pipeline. In November 2017,addition, we amended the agreement with Pfizer to extend theand GSK are actively working on multiple target nomination periodvalidation programs for the remaining two targets. Per the termsour GSK-partnered programs, for which all of the amended agreement, Pfizer is entitled to nominate the remaining two targetsour costs and expenses are prepaid by May 2018.GSK.

Financial Operations Overview

We have never been profitable, and since our inception, we have incurred significant operating losses. Our net loss for the three months ended June 30, 2023 and 2022 was $71.8$21.1 million and $36.9$41.3 million, inrespectively. Our net loss for the ninesix months ended SeptemberJune 30, 20172023 and 2016,2022 was $48.5 million and $79.1 million, respectively. As of SeptemberJune 30, 20172023 and December 31, 2016,2022, we had an accumulated deficit of $162.3$1,015.8 million and $90.5$967.3 million, respectively. We expect to continue to incur significant expenses and increasing operating losses for the foreseeable future.

14


Recent DevelopmentsRevenue

In July 2017, we commenced occupancy of our new 90,000 square foot manufacturing, laboratory and office facilityWe recognize collaboration revenue under the GSK Collaboration Agreement, which became effective in Lexington, Massachusetts. The facility is designed to produce active pharmaceutical ingredient under current good manufacturing practice (“cGMP”) and to have oligonucleotide synthesis capacity ranging from high throughput to large scale production. Our primary objectives for building this facility are to provide us and our current and future partners increased visibility and control of our drug product supply chain, greater independence, capacity and flexibilityJanuary 2023 (as defined in conducting clinical trials,Note 5), and the possibility of bringing disease-modifying therapies to patientsTakeda Collaboration Agreement (as defined in a potentially expedited manner.

Financial Operations Overview

Revenue

Note 5), which became effective in April 2018. We have not generated any product revenue since our inception and do not expect to generate any revenue from the sale of products for the foreseeable future. Our revenue during the three and nine months ended September 30, 2017 and 2016 represents revenue earned under the Pfizer Collaboration Agreement, which was entered into in May 2016.

Operating Expenses

Our operating expenses since inception have consisted primarily of research and development costsexpenses and general and administrative costs.expenses.

Research and Development Expenses

Research and development expenses consist primarily of costs incurred for our research activities, including our discovery efforts, and the development of our product candidates, which include:

compensation-related expenses, including employee salaries, bonuses, share-based compensation expense and other related benefits costs,expenses for personnel in our research and development organization;

expenses incurred under agreements with third parties, including contract research organizations (“CROs”) that conduct research, preclinical and clinical activities on our behalf, as well as contract manufacturing organizations (“CMOs”) that manufacture drug productsproduct for use in our preclinical studies and clinical trials;

costsexpenses incurred related to our internal manufacturing of third-party consultants, including fees, share-based compensationdrug substance for use in our preclinical studies and related travel expenses;

clinical trials;

the cost of sponsored expenses related to compliance with regulatory requirements;

expenses related to third-party consultants;
research which includes laboratoryand development supplies and services expenses; and
facility-related expenses, including rent, maintenance and other general operating costs; and

costs related to compliance with regulatory requirements.

expenses.

We recognize research and development costs as incurred. We recognize external development costs based on an evaluation of the progress to completion of specific tasks using information provided to us by our vendors. Payments for these activities are based on the terms of the individual agreements, which may differ from the pattern of costs incurred, and are reflected in our financial statements as prepaid or accrued research and development expenses.

Our primary research and development focus since inception has been the development of our innovativeproprietary discovery and proprietary synthetic chemistry drug development platform.platform, PRISM. We are using PRISM, which includes our platformnovel PN backbone chemistry modifications, to design,

23


develop and commercialize a broad pipeline of nucleic acid therapeutic candidates.candidates that target RNA using RNA editing, splicing, and silencing.

Our direct research and development expenses are tracked on a program-by-program basis and consist primarily of expenses related to our CROs, CMOs, consultants, other external vendors and fees paid to global regulatory agencies to conduct our clinical trials, in addition to compensation-related expenses, internal manufacturing expenses, facility-related expenses and other external costsgeneral operating expenses. These expenses are incurred in connection with research and development efforts and our preclinical studies and clinical studies and regulatory fees.trials. We track certain external expenses on a program-by-program basis. However, we do not allocate the cost of sponsored researchcompensation-related expenses, internal manufacturing expenses, equipment repairs and maintenance expense, facility-related expenses or other operating expenses to specific programs. These expenses, which are not allocated on a program-by-program basis, because these costs are deployed across multiple product programs under developmentincluded in the “PRISM and as such, are classified as costs of our research. The cost of sponsored research includes laboratory supplies, equipment repairs and maintenance and facility-related expenses.

15


The table below summarizes ourother research and development expenses” category along with other external expenses incurred onrelated to our discovery and development programs, as well as platform development and by program:identification of potential drug discovery candidates.

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2017

 

 

2016

 

 

2017

 

 

2016

 

 

 

(in thousands)

 

HD programs

 

$

2,144

 

 

$

3,791

 

 

$

6,637

 

 

$

6,949

 

DMD programs

 

 

4,178

 

 

 

994

 

 

 

11,089

 

 

 

1,861

 

ALS and FTD programs

 

 

183

 

 

 

 

 

 

693

 

 

 

 

Other discovery programs, platform development

   and identification of potential drug discovery

   candidates

 

 

13,592

 

 

 

8,901

 

 

 

35,521

 

 

 

18,013

 

Total research and development expenses

 

$

20,097

 

 

$

13,686

 

 

$

53,940

 

 

$

26,823

 

Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We expect that our compensation-related expenses, including salaries, bonuses, share-based compensation and other related benefits costs, will increase in the future as we attract and maintain additional personnel. We expect that ourto continue to incur significant research and development expenses will continue to increase in the foreseeable future as we continue to conduct andmanage our existing clinical trials, initiate additional clinical trials for certain of our product candidates, pursue later stages of clinical development for certain product candidates, maintain our manufacturing capabilities and continue to discover and develop additional product candidates and pursue later stages of clinical development of our product candidates. Additionally, we expect our facility-related expenses to increase related to the lease we entered into in 2016 for space in Lexington, Massachusetts, which we intend to use primarily for our cGMP manufacturing, as well as for additional laboratory and office space.multiple therapeutic areas.

General and Administrative Expenses

General and administrative expenses consist primarily of compensation-related expenses, including salaries, bonuses, share-based compensation and other related benefits costs for personnel in our executive, finance, corporate, business development, legal and administrative functions.functions, as well as compensation-related expenses for our board of directors. General and administrative expenses also include legal fees relating to intellectual property and general corporate matters;fees; expenses associated with being a public company; professional fees for accounting, auditing, tax and consulting services; insurance costs; travel expenses; other operating costs; and facility-related expenses.

We anticipate that our general and administrative expenses will increase in the future, primarily due to additional compensation-related expenses, including salaries, benefits, incentive arrangements and share-based compensation awards, as we increase our employee headcount to support the expected growth in our research and development activities and the potential commercialization of our product candidates.

Other Income, (Expense), netNet

Other income, (expense), net for the three and nine months ended September 30, 2017 and 2016 consistsis comprised primarily of dividend income and interest income earned on cashrefundable tax credits from tax authorities. We recognize refundable tax credits when there is reasonable assurance that we will comply with the requirements of the refundable tax credit and cash equivalents balances.that the refundable tax credit will be received.

Income Taxes

We are a Singapore multi-national company subject to taxation in the United States and various other jurisdictions. The income tax provision recorded during the three and nine months ended September 30, 2016 was primarily the result of U.S. income generated under research and management services arrangements between our U.S. and Singapore entities. The income tax benefit recorded during the three months ended September 30, 2017 was the result of the implementation of a revised international corporate structure aligned with our international operations. The income tax provision recorded during the nine months ended September 30, 2017 was mainly the result of the establishment of a valuation allowance against our U.S. deferred tax assets.

Critical Accounting Policies and Significant Judgments and Estimates

Our consolidated financial statements are prepared in accordance with generally accepted accounting principles in the United States of America. The preparation of our financial statements and related disclosures requires us to make estimates assumptions and judgmentsassumptions that affect the reported amount of assets, liabilities, revenue, costs and expenses revenue, and related disclosures.

16


Our critical Management considers many factors in selecting appropriate financial accounting policies and in developing the estimates and assumptions that are described underused in the caption “Management’s Discussion and Analysispreparation of Financial Condition and Results of Operations— Critical Accounting Policies and Significant Judgments and Estimates”the financial statements. Management must apply significant judgment in our 2016 Annual Report on Form 10-K filed with the SEC on March 16, 2017.this process. We believe that of our critical accounting policies, the accounting policies with respect to revenue recognition policy, particularly (a) assessing the number of performance obligations; (b) determining the transaction price; (c) allocating the transaction price to the performance obligations in the contract; and income taxes(d) determining the pattern over which performance obligations are satisfied, including estimates to complete performance obligations, and the assumptions and estimates used in our analysis of contracts with CROs and CMOs to estimate the contract expense, involve the mosta greater degree of judgment, and complexity. During the nine months ended September 30, 2017, there were no material changestherefore we consider them to be our critical accounting policies.

Accordingly, we believe these identified policies are critical to fully understanding We evaluate our estimates and evaluating our financial condition and results of operations. Ifassumptions on an ongoing basis. Our actual results or eventsmay differ materially from thethese estimates judgmentsunder different assumptions and assumptions used by us in applying these policies, our reported financial condition and results of operations could be materially affected.conditions.

24


Results of Operations

Comparison of the three months ended SeptemberJune 30, 20172023 and 2016:2022

 

Three Months Ended September 30,

 

 

 

 

 

 

Three Months Ended June 30,

 

 

 

 

 

2017

 

 

2016

 

 

Change

 

 

2023

 

 

2022

 

 

Change

 

 

(in thousands)

 

 

(in thousands)

 

Revenue

 

$

676

 

 

 

392

 

 

$

284

 

 

$

22,106

 

 

$

375

 

 

$

21,731

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

 

20,097

 

 

 

13,686

 

 

 

6,411

 

 

 

33,314

 

 

 

29,733

 

 

 

3,581

 

General and administrative

 

 

7,571

 

 

 

3,939

 

 

 

3,632

 

 

 

12,265

 

 

 

12,806

 

 

 

(541

)

Total operating expense

 

 

27,668

 

 

 

17,625

 

 

 

10,043

 

Total operating expenses

 

 

45,579

 

 

 

42,539

 

 

 

3,040

 

Loss from operations

 

 

(26,992

)

 

 

(17,233

)

 

 

(9,759

)

 

 

(23,473

)

 

 

(42,164

)

 

 

18,691

 

Other income (expense), net

 

 

441

 

 

 

82

 

 

 

359

 

Total other income, net

 

 

2,369

 

 

 

868

 

 

 

1,501

 

Loss before income taxes

 

 

(26,551

)

 

 

(17,151

)

 

 

(9,400

)

 

 

(21,104

)

 

 

(41,296

)

 

 

20,192

 

Income tax benefit (provision)

 

 

416

 

 

 

(384

)

 

 

800

 

Income tax provision

 

 

 

 

 

 

 

 

 

Net loss

 

$

(26,135

)

 

$

(17,535

)

 

$

(8,600

)

 

$

(21,104

)

 

$

(41,296

)

 

$

20,192

 

Revenue

The revenueRevenue for the three months ended SeptemberJune 30, 20172023 was $22.1 million and 2016 was earned under the PfizerGSK Collaboration Agreement which was entered into in May 2016. There was $0.7 million of revenueand the Takeda Collaboration Agreement. Revenue for the three months ended SeptemberJune 30, 2017, which represents an increase of $0.3 million over the2022 was $0.4 million ofand was earned primarily under the Takeda Collaboration Agreement, as the GSK Collaboration Agreement became effective in January 2023. The year-over-year increase is primarily driven by the revenue forearned under the three months ended September 30, 2016. This increase was the result of the nomination of the third target in August 2016.GSK Collaboration Agreement.

Research and Development Expenses

 

 

Three Months Ended June 30,

 

 

 

 

 

 

2023

 

 

2022

 

 

Change

 

 

 

(in thousands)

 

ALS and FTD program

 

$

3,334

 

 

$

3,348

 

 

$

(14

)

HD programs

 

 

4,095

 

 

 

1,253

 

 

 

2,842

 

DMD programs

 

 

2,255

 

 

 

392

 

 

 

1,863

 

AATD program

 

 

2,156

 

 

 

1,541

 

 

 

615

 

PRISM and other research and development expenses (1)

 

 

21,474

 

 

 

23,199

 

 

 

(1,725

)

Total research and development expenses

 

$

33,314

 

 

$

29,733

 

 

$

3,581

 

 

 

Three Months Ended September 30,

 

 

 

 

 

 

 

2017

 

 

2016

 

 

Change

 

 

 

(in thousands)

 

HD programs

 

$

2,144

 

 

$

3,791

 

 

$

(1,647

)

DMD programs

 

 

4,178

 

 

 

994

 

 

 

3,184

 

ALS and FTD programs

 

 

183

 

 

 

 

 

 

183

 

Other discovery programs, platform development

   and identification of potential drug discovery

   candidates

 

 

13,592

 

 

 

8,901

��

 

 

4,691

 

Total research and development expenses

 

$

20,097

 

 

$

13,686

 

 

$

6,411

 

(1)
Includes expenses related to discovery and development programs, identification of potential drug discovery candidates, compensation, internal manufacturing, equipment repairs and maintenance, facilities and other operating expenses, which are not allocated to specific programs.

Research and development expenses were $20.1$33.3 million for the three months ended SeptemberJune 30, 2017,2023, compared to $13.7$29.7 million for the three months ended SeptemberJune 30, 2016.2022. The increase of $6.4$3.6 million was due primarily to the following:

a less than $0.1 million decrease of $1.6 million in preclinical and clinicalexternal expenses related to our two HD programs;

ALS and FTD program, WVE-004 (PN-modified silencing oligonucleotide), which we discontinued in May 2023;

an increase of $3.2$2.8 million in preclinical and clinicalexternal expenses related to our HD programs, including our WVE-003 (PN-modified silencing oligonucleotide) program;

an increase of $1.9 million in external expenses related to our DMD programs, mainly driven by activities related to WVE-210201;

including WVE-N531 (PN-modified splicing oligonucleotide);

an increase of $0.2$0.6 million in preclinicalexternal expenses related to our ALSAATD program, WVE-006 (PN-modified RNA editing oligonucleotide); and

a decrease of $1.7 million in internal and our FTD program, each of which targets the C9orf72 mutation; and

17


an increase of $4.7 million in research and development expenses related to other discovery programs, platform development and identification of potential drug discovery candidates, due to an increase of $2.8 million in compensation-related expenses, which is the result of an increase in employee headcount, and an increase of $1.9 million in research and development supplies and services expenses and facility-related expenses.

Foreign currency translation did not have a significant impact on changes in our consolidatedexternal research and development expenses fromthat are not allocated on a program-by-program basis and are related to other discovery and development programs, including PRISM and the three months ended September 30, 2016identification of potential drug discovery candidates, mainly due to the three months ended September 30, 2017.decreases in external research and development expenses and compensation-related expenses, partially offset by increases in facilities-related expenses.

25


General and Administrative Expenses

General and administrative expenses were $7.6$12.3 million for the three months ended SeptemberJune 30, 2017,2023, as compared to $3.9$12.8 million for the three months ended SeptemberJune 30, 2016.2022. The increase of $3.7 million was the result of the increasesdecrease is primarily driven by decreases in compensation-related expenses, which is the result of the increase in employee headcount, as well aspartially offset by increases in facility-related expenses and other general operating expenses.

Foreign currency translation did not have a significant impact on changes in our consolidatedexternal general and administrative expenses fromand facilities-related expenses.

Other Income, Net

Other income, net for the three months ended SeptemberJune 30, 2016 to the three months ended September 30, 2017.2023 and 2022 was $2.4 million and $0.9 million, respectively, and consisted of dividend income and estimated refundable tax credits. The increase in other income year-over-year was driven by an increase in dividend income.

Income Tax Benefit (Provision)Provision

During the three months ended SeptemberJune 30, 20172023 and 2016, we recorded an income tax benefit of $0.4 million and an income tax provision of $0.4 million, respectively. The income tax provision recorded during the three months ended September 30, 2016 was primarily the result of U.S. income generated under research and management services arrangements between our U.S. and Singapore entities. The income tax benefit recorded during the three months ended September 30, 2017, was the result of the implementation of a revised international corporate structure aligned with our international operations. During the three months ended September 30, 2017 and 2016,2022, we recorded no income tax benefitsprovision. We maintained a full valuation allowance for the net operating losses incurredthree months ended June 30, 2023 and 2022 in Japan, Singapore, Ireland or the United Kingdom,all jurisdictions due to uncertainty regarding future taxable income in these jurisdictions.income.

Comparison of the ninesix months ended SeptemberJune 30, 20172023 and 2016:2022

The following table summarizes our results of operations

 

 

Six Months Ended June 30,

 

 

 

 

 

 

2023

 

 

2022

 

 

Change

 

 

 

(in thousands)

 

Revenue

 

$

35,035

 

 

$

2,125

 

 

$

32,910

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

 

64,293

 

 

 

57,203

 

 

 

7,090

 

General and administrative

 

 

24,500

 

 

 

25,180

 

 

 

(680

)

Total operating expenses

 

 

88,793

 

 

 

82,383

 

 

 

6,410

 

Loss from operations

 

 

(53,758

)

 

 

(80,258

)

 

 

26,500

 

Total other income, net

 

 

5,249

 

 

 

1,148

 

 

 

4,101

 

Loss before income taxes

 

 

(48,509

)

 

 

(79,110

)

 

 

30,601

 

Income tax provision

 

 

 

 

 

 

 

 

 

Net loss

 

$

(48,509

)

 

$

(79,110

)

 

$

30,601

 

Revenue

Revenue for the ninesix months ended SeptemberJune 30, 20172023 was $35.0 million and 2016:

 

 

Nine Months Ended September 30,

 

 

 

 

 

 

 

2017

 

 

2016

 

 

Change

 

 

 

(in thousands)

 

Revenue

 

$

2,028

 

 

 

809

 

 

$

1,219

 

Operating expenses

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

53,940

 

 

 

26,823

 

 

 

27,117

 

General and administrative

 

 

20,088

 

 

 

10,809

 

 

 

9,279

 

Total operating expense

 

 

74,028

 

 

 

37,632

 

 

 

36,396

 

Loss from operations

 

 

(72,000

)

 

 

(36,823

)

 

 

(35,177

)

Other income (expense), net

 

 

1,081

 

 

 

303

 

 

 

778

 

Loss before income taxes

 

 

(70,919

)

 

 

(36,520

)

 

 

(34,399

)

Income tax benefit (provision)

 

 

(905

)

 

 

(427

)

 

 

(478

)

Net loss

 

$

(71,824

)

 

$

(36,947

)

 

$

(34,877

)

Revenue

The revenue for the nine months ended September 30, 2017 and 2016 was earned under the PfizerGSK Collaboration Agreement which was entered into in May 2016. There was $2.0 million in revenueand the Takeda Collaboration Agreement. Revenue for the ninesix months ended SeptemberJune 30, 2017, which represents an increase of approximately $1.22022 was $2.1 million in revenue over the $0.8 million of revenue for the nine months ended September 30, 2016. This increase is due to the fact that nine months of revenue wereand was primarily earned under the PfizerTakeda Collaboration Agreement, duringas the nine months ended September 30, 2017, as compared toGSK Collaboration Agreement became effective in January 2023. The year-over-year increase is primarily driven by the five months of revenue that were earned under the PfizerGSK Collaboration Agreement for the nine months ended September 30, 2016 from the May 2016 effective date through September 30, 2016 as well as the fact that the third target was nominated in August 2016.Agreement.

1826


Research and Development Expenses

The table below summarizes our research

 

 

Six Months Ended June 30,

 

 

 

 

 

 

2023

 

 

2022

 

 

Change

 

 

 

(in thousands)

 

ALS and FTD program

 

$

6,051

 

 

$

5,087

 

 

$

964

 

HD programs

 

 

7,417

 

 

 

3,446

 

 

 

3,971

 

DMD programs

 

 

2,569

 

 

 

817

 

 

 

1,752

 

AATD program

 

 

3,724

 

 

 

1,852

 

 

 

1,872

 

PRISM and other research and development expenses (1)

 

 

44,532

 

 

 

46,001

 

 

 

(1,469

)

Total research and development expenses

 

$

64,293

 

 

$

57,203

 

 

$

7,090

 

(1)
Includes expenses related to discovery and development programs, identification of potential drug discovery candidates, compensation, internal manufacturing, equipment repairs and maintenance, facilities and other operating expenses, incurred for the nine months ended September 30, 2017 and 2016:

 

 

Nine Months Ended September 30,

 

 

 

 

 

 

 

2017

 

 

2016

 

 

Change

 

 

 

(in thousands)

 

HD programs

 

$

6,637

 

 

$

6,949

 

 

$

(312

)

DMD programs

 

 

11,089

 

 

 

1,861

 

 

 

9,228

 

ALS and FTD programs

 

 

693

 

 

 

 

 

 

693

 

Other discovery programs, platform development

   and identification of potential drug discovery

   candidates

 

 

35,521

 

 

 

18,013

 

 

 

17,508

 

Total research and development expenses

 

$

53,940

 

 

$

26,823

 

 

$

27,117

 

which are not allocated to specific programs.

Research and development expenses were $53.9$64.3 million for the ninesix months ended SeptemberJune 30, 20172023, compared to $26.8$57.2 million for the ninesix months ended SeptemberJune 30, 2016.2022. The increase of $27.1$7.1 million was due to the following:

a decreasean increase of $0.3$1.0 million in preclinical and clinical external expenses related to our two HD programs;

ALS and FTD program, WVE-004 (PN-modified silencing oligonucleotide), which we discontinued in May 2023;

an increase of $9.2$4.0 million in preclinicalexternal expenses related to our HD programs, driven by decreased external expenses related to our discontinued WVE-120101 and clinical WVE-120102 programs, partially offset by continuing external expenses for our WVE-003 (PN-modified silencing oligonucleotide) program;

an increase of $1.8 million in external expenses related to our DMD programs, mainly driven by activities related to WVE-210201;

including WVE-N531 (PN-modified splicing oligonucleotide);

an increase of $0.7$1.9 million in preclinicalexternal expenses related to our ALSAATD program, and our FTD program, each of which targets the C9orf72 mutationWVE-006 (PN-modified RNA editing oligonucleotide); and

an increasea decrease of $17.5$1.5 million in internal and external research and development expenses that are not allocated on a program-by-program basis and are related to other discovery and development programs, platform developmentincluding PRISM and the identification of potential drug discovery candidates, primarily due to an increase of $10.4 milliondecreases in compensation-related expenses, including an increase of $2.3 million in share-based compensation expense, which is the result of an increase in employee headcount, as well as an increase of $7.1 million in research and development supplies and services expenses and facility-related expenses.

Foreign currency translation did not have a significant impact on changes in our consolidatedexternal research and development expenses from the nine months ended September 30, 2016 to the nine months ended September 30, 2017.

and depreciation expenses, partially offset by increased compensation-related expenses and facilities related expenses.

General and Administrative Expenses

General and administrative expenses were $20.1$24.5 million for the ninesix months ended SeptemberJune 30, 2017,2023, as compared to $10.8approximately $25.2 million for the ninesix months ended SeptemberJune 30, 2016.2022. The increasedecrease of $9.3$0.7 million was the result of the increasesprimarily due to decreases in compensation-related expenses, which is the result of the increase in employee headcount, as well as increases in facility-related expenses and other general operating expenses.

Foreign currency translation did not have a significant impact on changes in our consolidatedpartially offset by increased external general and administrative expenses fromand facilities related expenses.

Other Income (Expense), Net

Other income, net for the ninesix months ended SeptemberJune 30, 2016 to2023 was $5.2 million and consisted primarily of dividend income, as well as estimated refundable tax credits. Other income, net for the ninesix months ended SeptemberJune 30, 2017.2022 was $1.1 million and primarily related to estimated refundable tax credits. The increase year-over-year was driven by the increase in dividend income.

Income Tax Benefit (Provision)Provision

During the ninesix months ended SeptemberJune 30, 20172023 and 2016, we recorded an income tax provision of $0.9 million and $0.4 million, respectively. The increase in the income tax provision was mainly the result of the establishment of a valuation allowance against our U.S. deferred tax assets. During the nine months ended September 30, 2017 and 2016,2022, we recorded no income tax benefitsprovision. We maintained a full valuation allowance for the net operating losses incurredsix months ended June 30, 2023 and 2022 in Japan, Singapore, Ireland or the United Kingdom,all jurisdictions due to uncertainty regarding future taxable income in these jurisdictions.income.

19

27


Liquidity and Capital Resources

To date we have primarily funded our operations through private placements of debt and equity securities, public offerings of our ordinary shares and collaborations. Through September 30, 2017, we have received an aggregate of approximately $323.2 million in net proceeds from these transactions. We received $89.3 million in net proceeds from private placements of our debt and equity securities, $100.4 million in net proceeds ($111.9 million gross proceeds) from our initial public offering, inclusive of the over-allotment exercise, $40.0 million under the Pfizer Agreements, including $10.0 million as an upfront payment under the Pfizer Collaboration Agreement and $30.0 million in the form of an equity investment, and $93.5 million in net proceeds ($100.0 million gross proceeds) from our April 2017 follow-on underwritten public offering.

Since our inception, we have not generated any product revenue and have incurred recurring net losses. To date, we have primarily funded our operations through public and other registered offerings of our ordinary shares, collaborations with third parties and private placements of debt and equity securities. Through June 30, 2023, we have received an aggregate of approximately $1,192.9 million in net proceeds from these transactions, consisting of $632.6 million in net proceeds from public and other registered offerings of our ordinary shares, $471.0 million from our collaborations and $89.3 million in net proceeds from private placements of our debt and equity securities.

As of SeptemberJune 30, 2017,2023, we had cash and cash equivalents totaling $168.5$173.0 million, restricted cash of $3.7 million and an accumulated deficit of $162.3 million and restricted cash of $3.6 million related to letters of credit for our leased premises in Cambridge, Massachusetts and Lexington, Massachusetts.$1,015.8 million.

We expect that the capital resources available to us as of September 30, 2017, together with anticipated milestone payments under our existing collaboration with Pfizer,cash and cash equivalents will be sufficient to fund our operating expenses and capital expenditure requirements into mid-2019.operations for at least the next twelve months. We have based this estimateexpectation on assumptions that may prove to be incorrect, and we may use our available capital resources sooner than we currently expect. In addition, we may elect to raise additional funds before we need them if the conditions for raising capital are favorable due to market conditions or strategic considerations, even if we believeexpect we have sufficient funds for our current or future operating plans.

Our operating lease commitments as of June 30, 2023 total approximately $42.2 million, of which $3.8 million is related to payments in 2023 and $38.4 million is related to payments beyond 2023.

Until we can generate significant revenue from product sales, if ever, we expect to continue to finance our operations through a combination of public or private equity or debt financings or other sources, which may include collaborations with third parties. On January 4, 2017,In May 2019, we filed a universal shelf registration statement on Form S-3ASR with the SEC pursuant to which we registered for sale an indeterminate amount of any combination of our ordinary shares, debt securities, warrants, rights and/or units from time to time and at prices and on terms that we may determine. Our shelf registration statement on Form S-3ASR also included a prospectus covering up to an aggregate of $250.0 million in ordinary shares that we may issue and sell from time to time, through Jefferies LLC (“Jefferies”) acting as our sales agent, pursuant to the open market sales agreement that we entered into with Jefferies in May 2019, as amended in March 2020 and March 2022 (as amended, the “Sales Agreement”), for our “at-the-market” equity program. Since we no longer qualified as a “well-known seasoned issuer” at the time of the filing of our Annual Report on Form 10-K for the year ended December 31, 2019, we previously amended the shelf registration statement to register for sale up to $500.0 million of any combination of our ordinary shares, debt securities, warrants, rights and/or units from time to time and at prices and on terms that we may determine, including the $250.0 million in ordinary shares that we may issue and sell from time to time pursuant to our “at-the-market” equity program. This registration statement, which we refer to as the “2019 Form S-3,” remained effective until our 2022 Form S-3 (as defined below) was declared effective on May 4, 2022, after which time we may no longer offer or sell any securities under the 2019 Form S-3. During the three months ended June 30, 2023, we sold 429,051 ordinary shares under our at-the-market equity program for aggregate gross proceeds of $1.9 million.

On March 3, 2022, we filed a new universal shelf registration on Form S-3 with the SEC, which was declared effective by the SEC on February 6, 2017, onMay 4, 2022, pursuant to which we registered for sale up to $500.0 million of any combination of our ordinary shares, debt securities, warrants, rights purchase contracts and/or units from time to time and at prices and on terms that we may determine. Afterdetermine, which we refer to as the closing“2022 Form S-3.” The 2022 Form S-3 includes a prospectus covering up to approximately $132.0 million in ordinary shares that had not yet been issued or sold under our Sales Agreement with Jefferies. As of our follow-on underwritten public offering on April 18, 2017, approximately $400.0June 30, 2023, we have $428.1 million ofin securities remain available for issuance under this shelf registration. This shelf registration statement will remainthe 2022 Form S-3, including approximately $130.1 million in effectordinary shares available for up to three years from the date it was declared effective. issuance under our at-the-market equity program.

Adequate additional financing may not be available to us on acceptable terms, or at all. Our inability to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. We will need to generate significant revenue to achieve profitability, and we may never do so.

28


Cash Flows

The following table summarizes our sources and uses of cash and cash equivalents forflow activity:

 

 

Six Months Ended June 30,

 

 

 

2023

 

 

2022

 

 

 

(in thousands)

 

Net cash provided by (used in) operating activities

 

$

48,265

 

 

$

(68,695

)

Net cash used in investing activities

 

 

(561

)

 

 

(25,594

)

Net cash provided by financing activities

 

 

36,902

 

 

 

67,116

 

Effect of foreign exchange rates on cash, cash equivalents and restricted cash

 

 

(121

)

 

 

(228

)

Net increase (decrease) in cash, cash equivalents and restricted cash

 

$

84,485

 

 

$

(27,401

)

Operating Activities

During the ninesix months ended SeptemberJune 30, 2017 and 2016:

 

 

Nine Months Ended September 30,

 

 

 

2017

 

 

2016

 

 

 

(in thousands)

 

Cash used in operating activities

 

$

(60,917

)

 

$

(18,578

)

Cash used in investing activities

 

 

(14,815

)

 

 

(2,834

)

Cash provided by financing activities

 

 

93,785

 

 

 

29,106

 

Effect of foreign exchange rates of cash

 

 

118

 

 

 

101

 

Net increase in cash and cash equivalents

 

$

18,171

 

 

$

7,795

 

Operating Activities

During the nine months ended September 30, 2017,2023, operating activities used approximately $60.9provided $48.3 million of cash, which was the result ofdue to our net loss of $71.8$48.5 million, offset by non-cash charges of $9.9 million and changes in operating assets and liabilities of $3.2 million, partially offset by non-cash charges of $14.1$86.9 million. The non-cash charges were mainly related to the share-based compensation expense of $9.0 million and the $3.2 million increase in deferred rent.

During the nine months ended September 30, 2016, operating activities used $18.6 million of cash, which was the result of our net loss of $36.9 million, partially offset by changes in operating assets and liabilities of $13.0 million and non-cash charges of $5.3 million. The non-cash charges were related primarily to share-based compensation of $4.3 million. The cash provided from changeslargest change in operating assets and liabilities was primarily the result of the $11.7a $104.3 million increase in deferred revenue, as a result of the upfront payments received pursuant to the Pfizer Agreements.mainly driven by our GSK Collaboration Agreement, which became effective in January 2023.

20


Investing Activities

During the ninesix months ended SeptemberJune 30, 2017,2022, operating activities used $68.7 million of cash, primarily due to our net loss of $79.1 million, offset by $10.9 million of share-based compensation expense.

Investing Activities

During the six months ended June 30, 2023, investing activities used $14.8$0.6 million of cash, consisting primarily ofrelated to purchases of property and equipment.

During the ninesix months ended SeptemberJune 30, 2016,2022, investing activities used $2.8$25.6 million of cash, consisting primarily of which $50.0 million related to purchases of short-term investments, $25.0 million of which was subsequently sold, and $0.6 million related to purchases and sales of property and equipment.

Financing Activities

During the ninesix months ended SeptemberJune 30, 2017,2023, net cash provided by financing activities was $93.8$36.9 million, which was primarily due to the $93.5 millionGSK Equity Investment (as defined in net proceeds from the April 2017 follow-on underwritten public offering of 4,166,667 ordinary shares.Note 5).

During the ninesix months ended SeptemberJune 30, 2016,2022, net cash provided by financing activities was $29.1$67.1 million, which was primarily due to the $30.0 million innet proceeds from the issuanceour previously disclosed June 2022 underwritten offering, which was comprised of 1,875,000sales of ordinary shares to an affiliate of Pfizer related to the Pfizer Equity Agreement.and Pre-Funded Warrants.

Effect of Foreign Exchange Rates on Cash

During the nine months ended September 30, 2017, the effect of changes in foreign exchange rates on cash was an increase in cash of $0.1 million, primarily due to changes in the Japanese yen from December 31, 2016 to September 30, 2017.

During the nine months ended September 30, 2016, the effect of changes in foreign exchange rates on cash was an increase in cash of $0.1 million, primarily due to changes in the Japanese yen from December 31, 2015 to September 30, 2016.

Funding Requirements

We expect our expenses to continue to increaseincur significant expenses in connection with our ongoing research and development activities and the establishment of our internal cGMP manufacturing capabilities. Weactivities. Furthermore, we anticipate that our expenses will increase substantiallycontinue to vary if and as we:

continue to conduct our two Phase 1b/2a clinical trials evaluating our product candidates WVE 102101 and WVE 102102 in patients with HD and our Phase 1 clinical trial evaluating our product candidate WVE-210201 in patients with DMD;

patients;

conduct research and preclinical development of discovery targets and advance additional programs into clinical development;

file clinical trial applications with global regulatory agencies and conduct clinical trials for our programs;

make strategic investments in expandingcontinuing to innovate our R&Dresearch and development platform, capabilitiesPRISM, and in optimizing our manufacturing processes and formulations;

developmaintain our manufacturing capabilities through outsourcingour internal facility and establishing a scalable manufacturing facility;

our CMOs;

maintain our intellectual property portfolio and consider the acquisition of complementary intellectual property;

seek and obtain regulatory approvals for our product candidates; and

respond to the impacts of the COVID-19 global pandemic, the conflict involving Russia and Ukraine, global economic uncertainty, rising inflation, rising interest rates or market disruptions on our business; and

establish and build capabilities to market, manufacturedistribute and distributesell our product candidates.

29


We may experience delays or encounter issues with any of the above, including but not limited to failed studies, complex results, safety issues or other regulatory challenges.

Because of the numerous risks and uncertainties associated with the development of drug candidates and because the extent to which we may enter into collaborations with third parties for development of product candidates is unknown, we are unable to estimate the amounts of increasedfuture capital outlays and operating expenses associated with completing the research and development for our therapeutic programs. Our future capital requirements for our therapeutic programs will depend on many factors, including:

the progress, results and resultscosts of conducting research and continued preclinical and clinical development withinfor our therapeutic programs and with respect to future potential pipeline candidates;

the number and characteristics of product candidates and programs that we pursue;

the cost of manufacturing clinical supplies of our product candidates;

whether and to what extent milestone events are achieved under our collaborations with Takeda and GSK or any potential future licensee or collaborator;

the costs, timing and outcome of regulatory review of our product candidates;

21


our ability to obtain marketing approval for our product candidates;
the impacts of the COVID-19 global pandemic, the conflict involving Russia and Ukraine, global economic uncertainty, rising inflation, rising interest rates or market disruptions on our business;
the costs and timing of future commercialization activities, including manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval;
market acceptance of our product candidates, to the extent any are approved for commercial sale, and timing of future commercialization activities, including manufacturing, marketing, sales and distribution, for any of our product candidates for which we receive marketing approval;

the revenue, if any, received from commercial sales of our product candidates for which we receive marketing approval;

the costs and timing of preparing, filing and prosecuting patent applications, maintaining and enforcing our intellectual property rights and defending any intellectual property-related claims;

the effect of competing technological and market developments; and

the extent to which we acquire or invest in businesses, products and technologies, including entering into licensing or collaboration arrangements for product candidates.

Identifying potential product candidates and conducting preclinical testing and clinical trials is a time-consuming, expensive and uncertain process that takes years to complete, and we may never generate the necessary data or results required to obtain marketing approval and achieve product sales. In addition, our product candidates, if approved, may not achieve commercial success. Our product revenue, if any, will be derived from sales of products that we do not expect to be commercially available for many years, if ever. Accordingly, we will need to obtain substantial additional funds to achieve our business objectives.

Adequate additional funds may not be available to us on acceptable terms when we need them, or at all. We do not currently have any committed external source of funds, except for possible future payments from Pfizer if milestonesTakeda or GSK under the Pfizer Collaboration Agreement are achieved. On January 4, 2017, we filed a universal shelf registration statement on Form S-3, which was declared effective by the SEC on February 6, 2017 (the “2017 Shelf”), on which we registered for sale up to $500.0 million of any combination of our ordinary shares, debt securities, warrants, rights, purchase contracts and/or units from time to time and at prices and on terms that we may determine. On April 18, 2017, we closed a follow-on underwritten public offering of 4,166,667 for gross proceeds of $100.0 million under the 2017 Shelf. Following that closing, approximately $400.0 million of securities remains available for issuance under the 2017 Shelf. This registration statement will remain in effect for up to three years from the date it was declared effective.collaborations with them. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our existing shareholders will be diluted, and the terms may include liquidation or other preferences that adversely affect the rights of our shareholders. Additional debt financing and preferred equity financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends and may require the issuance of warrants, which could potentially dilute our shareholders’ ownership interests.

If we raise additional funds through collaborations, strategic alliances or licensing arrangements with third parties, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development programs or any future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Contractual Obligations and Commitments30


There have been no material changes to our contractual obligations and commitments set forth under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations- Contractual Obligations and Commitments” in our 2016 Annual Report on Form 10-K filed with the SEC on March 16, 2017.

Off-Balance Sheet Arrangements

We had no off-balance sheet arrangements (as that term is defined in Item 303(a)(4)(ii) of Regulation S-K) as of September 30, 2017 that had or were reasonably likely to have a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

Recently Issued Accounting Pronouncements

For detailed information regarding recently issued accounting pronouncements and the expected impact on our consolidated financial statements, see Note 2, “Significant Accounting Policies” in the notes to the consolidated financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.

Item 3. Quantitative and Qualitative Disclosures aboutAbout Market Risk.Risk

Market risk represents the risk of loss that may impact our financial position due to adverse changes in financial market prices and rates. Our market risk exposure is primarily the result of fluctuations in interest rates and foreign exchange rates, as well as, to a lesser extent, inflation and capital market risk.

22


Interest Rate Risk

We are exposed to interest rate risk in the ordinary course of our business. Our cash and cash equivalents are comprised of funds held in readily available checking accounts and money market accounts.

Foreign Currency Risk

WeDue to our operations outside of the United States, we are exposed to market risk related to changes in the value of the Japanese yen, which is theforeign currency in whichexchange rates. Historically, we have not hedged our Japanese subsidiary conducts its business. As of September 30, 2017 and December 31, 2016, 0.1% and 0.2% of our assets, respectively, were located in Japan. Additionally, 0.8% and 0.5% of our general and administrative expenses were transacted in Japanese yen during the nine months ended September 30, 2017 and 2016, respectively. Furthermore, 1.0% and 2.1% of our research and development expenses were transacted in Japanese yen during the nine months ended September 30, 2017 and 2016, respectively. When the U.S. dollar strengthens relative to the yen, our U.S. dollar reported revenue and expense from non-U.S. dollar denominated income and operating costs will decrease. Conversely, when the U.S. dollar weakens relative to the yen, our U.S. dollar reported revenue and expenses from non-U.S. dollar denominated income and operating costs will increase.foreign currency exposure. Changes in the relative values of currencies occur regularly and, in some instances, could materially adversely affect our business, our financial conditions, our results of operations financial condition or our cash flows. Our foreign currency sensitivity is affected byFor the three and six months ended June 30, 2023 and 2022, changes in the Japanese yen, which is impacted by economic factors both locally in Japan and worldwide. A hypothetical 10% change in foreign currency exchange rates woulddid not have a material impact on our historical financial position, orour business, our financial condition, our results of operations.operations or our cash flows.

Inflation Risk

We do not believe that inflation had a material effect on our business, financial condition, or results of operations foror cash flows in the threelast two years. If global inflation trends continue, we expect appreciable increases in clinical trial, labor, and nine months ended September 30, 2017 and 2016.other operating costs.

Capital Market Risk

We currently have no product revenues and depend on funds raised through other sources. One possible source of funding is through further equity offerings. Our ability to raise funds in this manner depends in part upon capital market forces affecting our share price.price, including impacts of global economic uncertainty on the capital markets.

Item 4. Controls and Procedures.Procedures

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our principal executive officer and principal financial officer, evaluated the effectiveness of our disclosure controls and procedures as of SeptemberJune 30, 2017.2023. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act, of 1934, as amended, or the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to its management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of SeptemberJune 30, 2017,2023, our principal executive officer and principal financial officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.

Changes in Internal Control over Financial Reporting

There were no changes in our internal control over financial reporting identified in connection with the evaluation of such internal control required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act that occurred during the fiscal quarterthree months ended SeptemberJune 30, 20172023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

31


PART II – OTHER INFORMATION

We are not currently a party to any material legal proceedings.

23


Item 1A. Risk Factors.Risk Factors

In addition to the other information set forth in this Quarterly Report on Form 10-Q, you should carefully consider the factors discussed under the caption “Risk Factors” that appear in Item 1A of our 2022 Annual Report on Form 10-K for the year ended December 31, 2016, which was filed with the SEC on March 16, 2017 (the “2016 Annual Report on Form 10-K”), and in Item 1A of our Quarterly Report on Form 10-Q for the period ended June 30, 2017, which was filed with the SEC on August 9, 2017 (the “June 30 Quarterly Report on Form 10-Q”), which could materially affect our business, financial condition or results of operations. There have been no material changes from the risk factors previously disclosed in the 2016 Annual Report on Form 10-K, as supplemented and amended by the risk factors disclosed in the June 30 Quarterly Report on Form 10-Q.10-K.

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.Proceeds

(a)

Recent Sales of Unregistered Equity Securities

Recent Sales of Unregistered Equity Securities

None.

(b)

Use of Proceeds

On November 10, 2015,Issuer Purchases of Equity Securities

We did not repurchase any of our equity securities during the SEC declared our registration statement on Form S-1 (Registration No. 333-207379) effective for our initial public offering and we registered additional ordinary shares for our initial public offering on a registration statement on Form S-1 (Registration No. 333-207940) filed pursuant to Rule 462(b) of the Securities Act of 1933, as amended. The aggregate net proceeds to us from the offering, inclusive of the over-allotment exercise, were approximately $100.4 million, after deducting underwriting discounts and commissions and offering expenses payable by us. There has been no material change in the planned use of proceeds from our initial public offering as described in our final prospectus filed with the SEC on November 12, 2015 pursuant to Rule 424(b). We have used the net offering proceeds to advance our product candidates and for working capital and general corporate purposes. As of Septemberthree months ended June 30, 2017, we have used all of the net initial public offering proceeds.2023.

Item 3. Defaults Upon Senior Securities.Securities

None.

Item 4. Mine Safety Disclosures.Disclosures

Not applicable.

Item 5. Other Information.Information

Amendment to Pfizer Collaboration AgreementNone.

The information set forth in this paragraph is included herein for the purpose of providing the disclosure required under “Item 1.01 - Entry into a Material Definitive Agreement” of Form 8-K. On November 5, 2017, we amended our Research, License and Option Agreement (the “Pfizer Collaboration Agreement”) with Pfizer, Inc. (“Pfizer”) to extend the target nomination period from November 5, 2017 to May 5, 2018. This amendment provides Pfizer with an additional six months to nominate the two remaining hepatic targets under the Pfizer Collaboration Agreement.

Amendments to 2014 Equity Incentive Plan

As disclosed on Form 8-K/A filed with the Securities and Exchange Commission (“SEC”) on August 17, 2017, our shareholders approved, at our 2017 Annual General Meeting of Shareholders on August 10, 2017, amendments to the Wave Life Sciences Ltd. 2014 Equity Incentive Plan (the “2014 Plan”) to increase the total number of shares of common stock available for issuance under the plan by 1,000,000 shares, to increase by 150,000 shares the maximum number of shares available for grant to any participant in any fiscal year for purposes of meeting the requirements for qualified performance-based compensation under Section 162(m) of the Internal Revenue Code of 1986, as amended (the “Code”), and to provide our Compensation Committee with discretion to grant awards intended to qualify as “performance-based compensation” for purposes of Section 162(m) of the Code.  A description of the terms and conditions of the amendments to the 2014 Plan is set forth in our definitive proxy statement on Schedule 14A filed with the SEC on July 6, 2017, under the heading “Proposal 4: Approval of Amendments to 2014 Equity Incentive Plan,” and is incorporated herein by reference. Such description is qualified in its entirety by reference to the actual terms of the plan, a copy of which is filed as Exhibit 10.1 to this Quarterly Report on Form 10-Q.

2432


Description of Share Capital

The information set forth below in this “Item 5. Other Information” is included to amend the description of our share capital contained in our Registration Statement on Form 8-A filed with SEC, on November 9, 2015. We intend to incorporate the following description by reference into certain filings with the SEC, including registration statements on Form S-3 and Form S-8.

General

For the purposes of this section, references to “shareholders” mean those persons whose names and number of shares are entered in our register of members. Only persons who are registered in our register of members are recognized under Singapore law as shareholders of our company with legal standing to institute shareholder actions against us or otherwise seek to enforce their rights as shareholders. Our branch register of members is maintained by our transfer agent, Computershare Trust Company, N.A. (“Computershare”).

Certain of our ordinary shares are held through the Depository Trust Company (“DTC”). Accordingly, DTC or its nominee, Cede & Co., is the shareholder on record registered in our register of members for such shares. The holder of our shares held in book-entry through DTC or its nominee may become a registered shareholder by exchanging its interest in our shares for certificated shares and being registered in our register of members. The procedures by which a holder of book-entry interests held through DTC or its nominee may exchange such interests for certificated shares are determined by DTC and Computershare, in accordance with their internal policies and guidelines regulating the withdrawal and exchange of book-entry interests for certificated shares, and following such an exchange Computershare will perform the procedures to register the shares in the register.

Under the Singapore Companies Act, if (a) the name of any person is without sufficient cause entered in or omitted from the register of members; or (b) default is made or there is unnecessary delay in entering in the register of members the fact of any person having ceased to be a member, the person aggrieved or any member of the public company or the company itself, may apply to the Singapore courts for rectification of the register of members. The Singapore courts may either refuse the application or order rectification of the register of members, and may direct the company to pay any damages sustained by any party to the application. The Singapore courts will not entertain any application for the rectification of a register of members in respect of an entry which was made in the register of members more than 30 years before the date of the application.

As of September 30, 2017, there were outstanding:

27,767,905 ordinary shares;

3,901,348 Series A preferred shares held by one shareholder of record;

162,280 ordinary shares issuable upon vesting of outstanding restricted share units;

3,805,795 ordinary shares issuable upon the exercise of outstanding share options; and

1,730,546 ordinary shares reserved for issuance in connection with future grants under our equity incentive plan.

The following description of our share capital and provisions of our constitution (formerly known as our memorandum and articles of association) are summaries and are qualified by reference to the Singapore Companies Act and our constitution. A copy of our constitution has been filed with the SEC as an exhibit to our Annual Report on Form 10-K for the fiscal year ended December 31, 2016 filed with the SEC on March 16, 2017 and amended on April 28, 2017.

Ordinary Shares

As of September 30, 2017, our issued and paid-up ordinary share capital consists of 27,767,905 ordinary shares. We currently have only one class of issued ordinary shares, which have identical rights in all respects and rank equally with one another. Our ordinary shares have no par value and there is no authorized share capital under Singapore law. There is a provision in our constitution which provides that we may issue shares with such preferred, deferred or other special rights or such restrictions, whether in regard to dividend, voting, return of capital or otherwise as our board of directors may determine.

All our shares presently issued are fully paid-up, and existing shareholders are not subject to any calls on these shares. Although Singapore law does not recognize the concept of “non-assessability” with respect to newly-issued shares, we note that any purchaser of our shares who has fully paid up all amounts due with respect to such shares will not be subject under Singapore law to any personal liability to contribute to the assets or liabilities of our company in such purchaser’s capacity solely as a holder of such shares. We believe that this interpretation is substantively consistent with the concept of “non-assessability” under most, if not all, U.S. state corporations laws. All our shares are in registered form. We cannot, except in the circumstances permitted by the Singapore Companies Act, grant any financial assistance for the acquisition or proposed acquisition of our own shares. Except as described below under “— Takeovers,” there are no limitations imposed by the Singapore Companies Act or by our constitution on the right of shareholders not resident in Singapore to hold or vote ordinary shares.

25


Transfer Agent and Registrar

The transfer agent and registrar for our ordinary shares is Computershare Trust Company, N.A.

NASDAQ Global Market

Our ordinary shares are listed for quotation on The NASDAQ Global Market under the symbol “WVE.”

New Shares

Under the Singapore Companies Act, new shares may be issued only with the prior approval of our shareholders in a general meeting. General approval may be sought from our shareholders in a general meeting for the issue of shares. Approval, if granted, will lapse at the earlier of:

the conclusion of the next annual general meeting; or

the expiration of the period within which the next annual general meeting is required by law to be held (i.e., once every calendar year and within 15 months from the last preceding annual general meeting),

but any approval may be revoked or varied by the company in a general meeting.

Our shareholders have provided such general authority to issue new ordinary shares until the conclusion of our 2018 annual general meeting. Such approval will lapse in accordance with the preceding paragraph if our shareholders do not grant a new approval at our 2018 annual general meeting. Subject to this and the provisions of the Singapore Companies Act and our constitution, our board of directors may allot and issue or grant options over or otherwise dispose of new ordinary shares to such persons on such terms and conditions and with the rights and restrictions as they may think fit to impose.

Preferred Shares

Series A Preferred Shares

As of September 30, 2017, we have 3,901,348 Series A preferred shares outstanding. These shares are currently held by one of our largest shareholders, Shin Nippon Biomedical Laboratories, Ltd. The terms of the Series A preferred shares as set out in our constitution include (1) no voting rights at any general meeting other than in limited circumstances, (2) a liquidation preference equal to $0.002 per Series A preferred share, (3) no entitlement to dividends and (4) the right to convert the Series A preferred shares at any time on a one-for-one basis into ordinary shares at the discretion of the holder in accordance with the constitution.

The holders of the Series A preferred shares are not entitled to vote at any general meeting. The only instances in which the holders of the Series A preferred shares are able to vote at a general meeting would be if (but only if): the matters to be discussed at the meeting relate to or there is intent to pass resolutions on (i) abrogating or changing the rights attached to the Series A preferred shares; and (ii) for the winding up of the Company. Such resolutions would require the unanimous approval of the holders of the Series A preferred shares.

Other Preferred Shares

Under the Singapore Companies Act, different classes of shares in a public company may be issued only if (a) the issue of the class or classes of shares is provided for in the constitution of the public company and (b) the constitution of the public company sets out in respect of each class of shares the rights attached to that class of shares. Our constitution provides that we may issue shares of a different class with preferred, deferred or other special rights, or such restrictions, whether in regard to dividend, voting, return of capital or otherwise as our board of directors may determine. Under Singapore law, our preferred shareholders will have the right to attend any general meeting and in a poll at such general meeting, to have at least one vote for every preferred share held:

upon any resolution concerning the voluntary winding-up of our company under Section 290 of the Singapore Companies Act;

upon any resolution which varies the rights attached to such preferred shares; or

in the case of preferred shares issued after August 15, 1984, but before the commencement of Section 96 of the Companies (Amendment) Act 2014, when the dividends to be paid on our preferred shares or any part thereof are more than twelve months in arrears and unpaid, for the period they remain in arrears and unpaid.

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We may, subject to the Singapore Companies Act and the prior approval in a general meeting of our shareholders, issue preferred shares which are, or at our option or are to be, subject to redemption provided that such preferred shares may not be redeemed out of capital unless:

all the directors have made a solvency statement in relation to such redemption; and

we have lodged a copy of the statement with the Accounting and Corporate Regulatory Authority of Singapore.

Further, such shares must be fully paid-up before they are redeemed.

As of September 30, 2017, we have no preferred shares outstanding other than the Series A preferred shares described above. At present, we have no plans to issue additional preferred shares.

Registration Rights Under Our Investors’ Rights Agreement

As of September 30, 2017, the holders of approximately 7.4 million of our ordinary shares are entitled to rights with respect to the registration of these shares under the Securities Act. These rights are provided under the terms of the Investors’ Rights Agreement dated as of August 14, 2015 between us and the holders of these shares, and include demand registration rights, Form S-3 registration rights and piggyback registration rights. We are generally required to bear all registration expenses incurred in connection with the demand, Form S-3 and piggyback registrations described below, other than underwriting commissions and discounts, and will pay the reasonable fees and expenses, not to exceed $25,000, of one special counsel to represent all participating shareholders in a registration.

Demand Registration Rights

Under the terms of the Investors’ Rights Agreement, we will be required, upon the request of holders of at least 50% of the then-outstanding shares of Registrable Securities, as such term is defined in the Investors’ Rights Agreement, requesting registration of at least 50% of the then-outstanding shares of Registrable Securities having an anticipated aggregate offering price of at least $25.0 million, net of selling expenses, to effect the registration of such shares on Form S-1 for public resale. We are required to effect only one registration pursuant to this provision of the Investors’ Rights Agreement.

Form S-3 Registration Rights

At any time that we are entitled under the Securities Act to register our shares on Form S-3 and the holders of at least 30% of the then-outstanding Registrable Securities request that we register their shares for public resale on Form S-3 with an aggregate offering price of the shares to be registered of at least $5.0 million, net of selling expenses, we will be required to effect such registration. If, however, our chief executive officer certifies that, in the good faith judgment of our board of directors, it would be materially detrimental to us and our shareholders for such registration to become or remain effective because such action would (i) materially interfere with a significant acquisition, corporate reorganization or similar transaction involving us, (ii) require premature disclosure of material information that we have a bona fide business purpose for preserving as confidential, or (iii) render us unable to comply with requirements under the Securities Act or Exchange Act, then we will have the right to defer the registration for up to 120 days. We are only obligated to effect up to one registration on Form S-3 within any 12 month period.

Piggyback Registration Rights

If we register any of our securities either for our own account or for the account of other shareholders, the holders of these shares are entitled to include their shares in the registration. Subject to certain exceptions, we and the underwriters may limit the number of shares included in the underwritten offering if the underwriters believe that including these shares would adversely affect the offering.

Indemnification

Our Investors’ Rights Agreement contains customary cross-indemnification provisions, under which we are obligated to indemnify holders of registrable securities in the event of material misstatements or omissions in the registration statement attributable to us, and they are obligated to indemnify us for material misstatements or omissions attributable to them.

Termination of Registration Rights

The registration rights granted under the Investors’ Rights Agreement will terminate on the third anniversary of the closing of our initial public offering (November 16, 2018), or, with respect to any holder of registrable securities, such earlier time as all such registrable securities held by such holder are available for resale without limitation during a three-month period without registration, pursuant to Rule 144 or another similar exemption under the Securities Act.

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Registration Rights under our Share Purchase Agreement

Under the terms of our Share Purchase Agreement dated as of May 5, 2016 with an affiliate of Pfizer Inc. (the “Pfizer Affiliate”), the Pfizer Affiliate agreed that the 1,875,000 ordinary shares that the Pfizer Affiliate purchased from us under the Share Purchase Agreement (the “Pfizer Shares”) are subject to a lock-up restriction, such that the Pfizer Affiliate will not, and will also cause its affiliates not to, without our prior approval, sell, transfer or otherwise dispose of the Pfizer Shares until certain specified periods of time after the effective date of the Share Purchase Agreement. For a certain period following the expiration of the lock-up period, subject to certain conditions and limitations, we agreed to provide certain demand registration rights to the Pfizer Affiliate in order to register all or a portion of the Pfizer Shares purchased by the Pfizer Affiliate. We also provided the Pfizer Affiliate with certain “piggyback” registration rights for a certain period following the expiration of the lock-up period, subject to certain conditions and limitations, such that when we propose to register our ordinary shares for our account, the Pfizer Affiliate will have the right to include some or all of the Pfizer Shares in such registration. The Share Purchase Agreement also contains other customary terms and conditions of the parties with respect to the registration of the Pfizer Shares.

Transfer of Ordinary Shares

Subject to applicable securities laws in relevant jurisdictions and our constitution, our ordinary shares are freely transferable. Our constitution provides that shares may be transferred by a duly signed instrument of transfer in any usual or common form or in a form approved by the directors and NASDAQ. The directors may decline to register any transfer unless, among other things, evidence of payment of any stamp duty payable with respect to the transfer is provided together with other evidence of ownership and title as the directors may reasonably require to show the right of the transferor to make the transfer. We will replace lost or destroyed certificates for shares upon notice to us and upon, among other things, the applicant furnishing evidence and indemnity as the directors may require and the payment of all applicable fees.

Election and Re-election of Directors

We may, by ordinary resolution, remove any director before the expiration of his or her period of office, notwithstanding anything in our constitution or in any agreement between us and such director. We may also, by an ordinary resolution, appoint another person in place of a director removed from office pursuant to the foregoing.

Under our constitution, subject to the Singapore Companies Act, any director shall retire at the next annual general meeting and shall then be eligible for re-election at that meeting.

Our board of directors shall have the power, at any time and from time to time, to appoint any person to be a director either to fill a casual vacancy or as an additional director so long as the total number of directors shall not at any time exceed the maximum number (if any) fixed by or in accordance with our constitution.

Shareholders’ Meetings

We are required to hold an annual general meeting each calendar year and not more than 15 months after the date of our most recent annual general meeting. The directors may convene an extraordinary general meeting whenever they think fit and they must do so upon the written request of shareholders holding not less than 10% of the total number of paid-up shares as of the date of deposit of the requisition carrying the right to vote at a general meeting. In addition, two or more shareholders holding not less than 10% of our total number of issued shares (excluding our treasury shares) may call a meeting of our shareholders.

The Singapore Companies Act provides that a shareholder is entitled to attend any general meeting and speak on any resolution put before the general meeting. Unless otherwise required by law or by our constitution, resolutions put forth at general meetings may be decided by ordinary resolution, requiring the affirmative vote of a majority of the shareholders present in person or represented by proxy at the meeting and entitled to vote on the resolution. An ordinary resolution suffices, for example, for appointments of directors. A special resolution, requiring an affirmative vote of not less than three-fourths of the shareholders present in person or represented by proxy at the meeting and entitled to vote on the resolution, is necessary for certain matters under Singapore law, such as an alteration of our constitution. A shareholder entitled to attend and vote at a meeting of the company, or at a meeting of any class of shareholders of the company, shall be entitled to appoint another person or persons, whether a shareholder of the company or not, as his proxy to attend and vote instead of the shareholder at the meeting. Under the Singapore Companies Act, a proxy appointed to attend and vote instead of the shareholder shall also have the same right as the shareholder to speak at the meeting, but unless the constitution of the company otherwise provides, (i) a proxy shall not be entitled to vote except on a poll, (ii) a shareholder shall not be entitled to appoint more than two proxies to attend and vote at the same meeting and (iii) where a shareholder appoints two proxies the appointment shall be invalid unless the shareholder specifies the proportions of his holdings to be represented by each proxy.

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Notwithstanding the foregoing, a registered shareholder entitled to attend and vote at a meeting of the company held pursuant to an order of court under Section 210(1) of the Singapore Companies Act, or at any adjourned meeting under Section 210(3) of the Singapore Companies Act, is, unless the court orders otherwise, entitled to appoint only one proxy to attend and vote at the same meeting, and except where the aforementioned applies, a registered shareholder having a share capital who is a relevant intermediary (as defined under the Singapore Companies Act) may appoint more than two proxies in relation to a meeting to exercise all or any of his rights to attend and to speak and vote at the meeting, but each proxy must be appointed to exercise the rights attached to a different share or shares held by him (which number and class of shares shall be specified), and at such meeting, the proxy has the right to vote on a show of hands.

Only registered shareholders of our company, and their proxies, will be entitled to attend, speak and vote at any meeting of shareholders. Under the Singapore Companies Act, public companies may issue non-voting shares and shares that confer special, limited or conditional voting rights, such that the holder of a share may vote on a resolution before a general meeting of the company if, in accordance with the provisions of Section 64 of the Singapore Companies Act, the share confers on the holder a right to vote on that resolution.

Voting Rights

As provided under our constitution and the Singapore Companies Act, voting at any meeting of shareholders is by show of hands unless a poll has been demanded prior to the declaration of the result of the show of hands by, among others, (i) the chairman or (ii) at least one shareholder present in person or by proxy or by attorney or, in the case of a corporation, by a representative entitled to vote thereat, in each case representing in the aggregate not less than 5% of the total voting rights of all shareholders having the right to vote at the general meeting, provided that no poll shall be demanded in respect of an election of a chairman or relating to any adjournment of such meeting. On a poll every shareholder who is present in person or by proxy or by attorney, or in the case of a corporation, by a representative, has one vote for every share held by such shareholder. Proxies need not be shareholders.

Only those shareholders who are registered in our register of members as holders of ordinary shares will be entitled to vote at any meeting of shareholders. Therefore, DTC, or its nominee, will grant an omnibus proxy to DTC participants holding our shares in book-entry form through a broker, bank, nominee, or other institution that is a direct or indirect participant in the DTC. Such shareholders will have the right to instruct their broker, bank, nominee or other institution holding these shares on how to vote such shares by completing the voting instruction form provided by the applicable broker, bank, nominee, or other institution. Whether voting is by a show of hands or by a poll, DTC’s vote will be voted by the chairman of the meeting according to the results of the DTC’s participants’ votes (which results will reflect the instructions received from shareholders that own our shares electronically in book-entry form).

Minority Rights

The rights of minority shareholders of Singapore companies are protected, among other things, under Section 216 of the Singapore Companies Act, which gives the Singapore courts a general power to make any order, upon application by any shareholder of a company, as they think fit to remedy any of the following situations:

the affairs of a company are being conducted or the powers of the board of directors are being exercised in a manner oppressive to, or in disregard of the interests of, one or more of the shareholders, including the applicant; or

a company takes an action, or threatens to take an action, or the shareholders pass a resolution, or propose to pass a resolution, which unfairly discriminates against, or is otherwise prejudicial to, one or more of the shareholders, including the applicant.

Singapore courts have wide discretion as to the remedy they may grant, and the remedies listed in the Singapore Companies Act itself are not exclusive. In general, Singapore courts may, with a view to bringing to an end or remedying the matters complained of:

direct or prohibit any act or cancel or modify any transaction or resolution;

regulate the conduct of the affairs of the company in the future;

authorize civil proceedings to be brought in the name of, or on behalf of, the company by a person or persons and on such terms as the court may direct;

provide for the purchase of a minority shareholder’s shares by the other shareholders or by the company itself;

in the case of a purchase of shares by the company provide for a reduction accordingly of the company’s capital; or

provide that the company be wound up.

29


Dividends

Subject to any preferential rights of holders of any outstanding preferred shares, holders of our ordinary shares will be entitled to receive dividends and other distributions in cash, shares or property as may be declared by our company from time to time. We may, by ordinary resolution, declare dividends at a general meeting of shareholders, but we are restricted from paying dividends in excess of the amount recommended by our board of directors. Pursuant to Singapore law and our constitution, no dividend may be paid except out of our profits. To date, we have not declared any cash dividends on our ordinary shares and have no current plans to pay cash dividends in the foreseeable future.

Bonus and Rights Issues

In a general meeting, our shareholders may, upon the recommendation of the directors, capitalize any reserves or profits and distribute them as bonus shares, credited as paid-up, to the shareholders in proportion to their shareholdings.

Subject to the provisions of the Singapore Companies Act and our constitution, our directors may also issue rights to take up additional ordinary shares to our shareholders in proportion to their respective ownership. Such rights are subject to any condition attached to such issue and the regulations of any stock exchange on which our shares are listed, as well as U.S. federal and blue sky securities laws applicable to such issue.

Takeovers

The Singapore Code on Take-overs and Mergers applies to, among other things, the acquisition of voting shares of Singapore-incorporated public companies. Any person acquiring, whether by a series of transactions over a period of time or not, either on his or her own or together with parties acting in concert with such person, 30% or more of our voting shares, or, if such person holds, either on his or her own or together with parties acting in concert with such person, between 30% and 50% (both amounts inclusive) of our voting shares, and if such person (or parties acting in concert with such person) acquires additional voting shares representing more than 1% of our voting shares in any six-month period, must, except with the consent of the Securities Industry Council in Singapore, extend a mandatory takeover offer for the remaining voting shares in accordance with the provisions of the Singapore Code on Take-overs and Mergers. Responsibility for ensuring compliance with the Singapore Code on Take-overs and Mergers rests with parties (including company directors) to a take-over or merger and their advisors.

“Parties acting in concert” comprise individuals or companies who, pursuant to an agreement or understanding (whether formal or informal), cooperate, through the acquisition by any of them of shares in a company, to obtain or consolidate effective control of that company. Certain persons are presumed (unless the presumption is rebutted) to be acting in concert with each other. They are as follows:

a company, its parent company, subsidiaries and fellow subsidiaries, the associated companies of any of the company and its related companies, subsidiaries and fellow subsidiaries, companies whose associated companies include any of these companies and any person who has provided financial assistance (other than a bank in the ordinary course of business) to any of the foregoing for the purchase of voting rights;

a company with any of its directors (together with their close relatives, related trusts and companies controlled by any of the directors, their close relatives and related trusts);

a company with any of its pension funds and employee share schemes;

a person with any investment company, unit trust or other fund whose investment such person manages on a discretionary basis, but only in respect of the investment account which such person manages;

a financial or other professional adviser, including a stockbroker, with its client in respect of the shareholdings of (i) the adviser and persons controlling, controlled by or under the same control as the adviser and (ii) all the funds managed by the adviser on a discretionary basis, where the shareholdings of the adviser and any of those funds in the client total 10% or more of the client’s equity share capital;

directors of a company (together with their close relatives, related trusts and companies controlled by any of such directors, their close relatives and related trusts) which is subject to an offer or where the directors have reason to believe a bona fide offer for their company may be imminent;

partners; and

an individual and (i) such person’s close relatives, (ii) such person’s related trusts, (iii) any person who is accustomed to act in accordance with such person’s instructions, (iv) companies controlled by the individual, such person’s close relatives, related trusts or any person who is accustomed to act in accordance with such person’s instructions and (v) any person who has provided financial assistance (other than a bank in the ordinary course of business) to any of the foregoing for the purchase of voting rights.

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Subject to certain exceptions, a mandatory offer must be in cash or be accompanied by a cash alternative at not less than the highest price paid by the offeror or parties acting in concert with the offeror during the offer period and within the six months prior to its commencement.

Under the Singapore Code on Take-overs and Mergers, where effective control of a company is acquired or consolidated by a person, or persons acting in concert, a general offer to all other shareholders is normally required. An offeror must treat all shareholders of the same class in an offeree company equally. A fundamental requirement is that shareholders in the company subject to the takeover offer must be given sufficient information, advice and time to consider and decide on the offer. These legal requirements may impede or delay a takeover of our company by a third-party.

We may submit an application to the Securities Industry Council of Singapore for a waiver from the Singapore Code on Take-overs and Mergers so that the Singapore Code on Take-overs and Mergers will not apply to our company for so long as we are not listed on a securities exchange in Singapore. We will make an appropriate announcement if we submit the application and when the result of the application is known.

Liquidation or Other Return of Capital

On a winding-up or other return of capital, subject to any special rights attaching the Series A preferred shares or to any other class of shares, holders of ordinary shares will be entitled to participate in any surplus assets in proportion to their shareholdings.

Limitations of Liability and Indemnification Matters

Under Section 172 of the Singapore Companies Act, any provision exempting or indemnifying the officers of a company (including directors) against any liability that would otherwise attach to them in connection with any negligence, default, breach of duty or breach of trust in relation to the company is void. However, a company is not prohibited from (a) purchasing and maintaining for any such individual insurance against liability incurred by him or her in connection with any negligence, default, breach of duty or breach of trust in relation to the company, or (b) indemnifying the individual against liability incurred by him or her to a person other than the company except when the indemnity is against any liability (i) of the individual to pay a fine in criminal proceedings, (ii) of the individual to pay a penalty in respect of non-compliance with any requirements of a regulatory nature (howsoever arising), (iii) incurred by the individual in defending criminal proceedings in which he or she is convicted, (iv) incurred by the individual in defending civil proceedings brought by the company or a related company in which judgment is given against him or her, or (v) incurred by the individual in connection with an application for relief under Section 76A(13) or Section 391 of the Singapore Companies Act in which the court refuses to grant him or her relief.

Subject to the Singapore Companies Act and every other Singapore statute for the time being in force concerning companies and affecting us, our constitution provides that each of our directors and other officers and those of our subsidiaries and affiliates shall be entitled to be indemnified by us or such subsidiary against any liability incurred by him or her arising out of or in connection with any acts, omissions or conduct, actual or alleged, by such individual acting in his or her capacity as either director, officer, secretary or employee of us or the relevant subsidiary, except to such extent as would not be permitted under applicable Singapore laws or which would otherwise result in such indemnity being void in accordance with the provisions of the Singapore Companies Act.

Subject to the Singapore Companies Act and every other Singapore statute for the time being in force and affecting our company, we may indemnify our directors and officers against costs, charges, fees and other expenses that may be incurred by any of them in defending any proceedings (whether civil or criminal) relating to anything done or omitted or alleged to be done or omitted by such person acting in his or her capacity as a director, officer or employee of our company, in which judgment is given in his or her favor, or in which he or she is acquitted or in which the courts have granted relief pursuant to the provisions of the Singapore Companies Act, provided that such indemnity shall not extend to any liability which by law would otherwise attach to him or her in respect of any negligence, default, breach of duty or breach of trust of which he may be guilty in relation to our company, or which would otherwise result in such indemnity being voided under applicable Singapore laws.

No director or officer of our company shall be liable for any acts, omissions, neglects, defaults or other conduct of any other director or officer, and to the extent permitted by Singapore law, our company shall contribute to the amount paid or payable by a director or officer in such proportion as is appropriate to reflect the relative fault of such director or officer, taking into consideration any other relevant equitable considerations, including acts of other directors or officers and our company, and the relative fault of such parties in respect thereof.

In addition, subject to the Singapore Companies Act and every other Singapore statute for the time being in force and affecting our company, no director, managing director or other officer shall be liable for the acts, receipts, neglects or defaults of any other director or officer, or for joining in any receipt or other act for conformity, or for any loss or expense incurred by us, through the insufficiency or deficiency of title to any property acquired by order of the directors for us or for the insufficiency or deficiency of any security upon which any of our moneys are invested or for any loss or damage arising from the bankruptcy, insolvency or tortious act of any person with whom any moneys, securities or effects are deposited, or any other loss, damage or misfortune which happens in the execution of his duties, unless the same happens through his own negligence, default, breach of duty or breach of trust.

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We have entered into deeds of indemnity with each of our directors and officers. These agreements will require us to indemnify these individuals to the fullest extent permitted under our constitution and the Singapore Companies Act against liabilities that may arise by reason of their service to us as a director or officer of the company (as the case may be), and to advance expenses incurred in connection with any proceeding against them by reason of their status as a director, officer, agent or employee of the company in accordance with the terms of the deeds. These indemnification rights shall not be exclusive of any other right which an indemnified person may have or thereafter acquire under any applicable law, provision of our constitution, agreement, vote of shareholders or disinterested directors or otherwise.

We expect to maintain standard policies of insurance that provide coverage (1) to our directors and officers against loss rising from claims made by reason of breach of duty or other wrongful act and (2) to us with respect to indemnification payments that we may make to such directors and officers.

Item 6. Exhibits.Exhibits

Exhibit

Number

Exhibit Description

Filed

with this

Report

Incorporated by

Reference herein

from Form or

Schedule

Filing

Date

SEC

File/Reg.

Number

 10.1+4.1

Wave Life Sciences Ltd. 2014 Equity Incentive Plan, as amendedDescription of Securities of the Registrant and Comparison of Shareholder Rights

X

 10.2+31.1

Form of Non-qualified Share Option Agreement under the 2014 Equity Incentive Plan, as amended

X

 10.3+

Form of Incentive Share Option Agreement under the 2014 Equity Incentive Plan, as amended

X

 10.4+

Form of Restricted Share Unit Agreement under the 2014 Equity Incentive Plan, as amended

X

 10.5+

Form of Non-qualified Share Option Agreement for UK Participants under the 2014 Equity Incentive Plan, as amended

X

 31.1

Rule 13a-14(a)/15d-14(a) Certification of Principal Executive Officer

X

31.2

Rule 13a-14(a)/15d-14(a) Certification of Principal Financial Officer

X

32*

Section 1350 Certifications of Principal Executive Officer and Principal Financial Officer

X

101.INS

Inline XBRL Instance Document – The instance document does not appear in the interactive data file because its Inline XBRL tags are embedded within the Inline XBRL document

X

101.SCH

Inline XBRL Taxonomy Extension Schema Document

X

101.CAL

Inline XBRL Taxonomy Extension Calculation Linkbase Document

X

101.DEF

Inline XBRL Taxonomy Extension Definition Linkbase Document

X

101.LAB

Inline XBRL Taxonomy Extension Label Linkbase Document

X

101.PRE

Inline XBRL Taxonomy Extension Presentation Linkbase Document

X

104

Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101)

X

(*)

The certifications attached as Exhibit 32 that accompany this Quarterly Report on Form 10-Q are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Wave Life Sciences Ltd. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of such Form 10-Q), irrespective of any general incorporation language contained in such filing.

(+)

Indicates management contract or compensatory plan.

(*) The certifications attached as Exhibit 32 that accompany this Quarterly Report on Form 10-Q are not deemed filed with the Securities and Exchange Commission and are not to be incorporated by reference into any filing of Wave Life Sciences Ltd. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended (whether made before or after the date of such Form 10-Q), irrespective of any general incorporation language contained in such filing.

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SIGNATURES

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Date: November 9, 2017

WAVE LIFE SCIENCES LTD.

By:Date: August 3, 2023

By:

/s/ Paul B. Bolno, M.D., MBA

Paul B. Bolno, M.D., MBA

President and Chief Executive Officer

(Principal Executive Officer)

By:Date: August 3, 2023

By:

/s/ Keith C. RegnanteKyle Moran

Keith C. Regnante

Kyle Moran

Chief Financial Officer
(Principal
(Principal Financial Officer and Principal Accounting Officer)

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