10-Q
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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 September 30, 2022

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

For the transition period from ______ to ______

Commission File 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)

 

00-0000000

(I.R.S. Employer Identification No.)

 

 

 

7 Straits View #12-00, Marina One East Tower

Singapore

(Address of principal executive offices)

 

018936

(Zip Code)

 

+65 6236 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 every Interactive Data File required to be submitted 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 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-2 of the Exchange Act.

 

Large accelerated filer

 

Accelerated filer

Non-accelerated filer

 

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, 2022 was 86,900,688.

 

 


 

WAVE LIFE SCIENCES LTD.

QUARTERLY REPORT ON FORM 10-Q

TABLE OF CONTENTS

 

 

 

Page

PART I - FINANCIAL INFORMATION

 

5

Item 1. Financial Statements

 

5

Unaudited Consolidated Balance Sheets

 

5

Unaudited Consolidated Statements of Operations and Comprehensive Loss

 

6

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

 

7

Unaudited Consolidated Statements of Cash Flows

 

9

Notes to Unaudited Consolidated Financial Statements

 

10

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

 

20

Item 3. Quantitative and Qualitative Disclosures About Market Risk

 

34

Item 4. Controls and Procedures

 

34

PART II - OTHER INFORMATION

 

35

Item 1. Legal Proceedings

 

35

Item 1A. Risk Factors

 

35

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

 

35

Item 3. Defaults Upon Senior Securities

 

35

Item 4. Mine Safety Disclosures

 

35

Item 5. Other Information

 

36

Item 6. Exhibits

 

37

 

2


 

As used 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 our 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 relate to future events or to our future operations or financial performance. Any forward-looking statement involves known and unknown risks, uncertainties and 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, 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 future 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, duration, timing or results of our research and development activities, preclinical studies and clinical trials, including the timing for initiation or completion of or availability of results from any preclinical studies and clinical 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 commercialization, marketing and manufacturing capabilities and strategy; 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 competitors in the industry; our liquidity and working capital requirements; the expected impact of new accounting standards; and our expectations regarding the impact of 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 are 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, level of activity, performance or achievements expressed or implied by 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; competition from others developing therapies for similar uses; the severity and duration of the COVID-19 pandemic; the COVID-19 pandemic, and variants thereof, may negatively impact the conduct of, and the timing of enrollment, completion and reporting with respect to, our clinical trials; any other 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 other 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 Securities and Exchange Commission.

 

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 report 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 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.

 

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 Form 10-Q are the property of Wave Life Sciences Ltd. This 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 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 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.

4


 

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements

WAVE LIFE SCIENCES LTD.

UNAUDITED CONSOLIDATED BALANCE SHEETS

(In thousands, except share amounts)

 

 

 

September 30, 2022

 

 

December 31, 2021

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

96,954

 

 

$

150,564

 

Short-term investments

 

 

25,044

 

 

 

 

Prepaid expenses

 

 

7,419

 

 

 

6,584

 

Other current assets

 

 

2,017

 

 

 

5,416

 

Total current assets

 

 

131,434

 

 

 

162,564

 

Long-term assets:

 

 

 

 

 

 

Property and equipment, net

 

 

18,552

 

 

 

22,266

 

Operating lease right-of-use assets

 

 

27,827

 

 

 

18,378

 

Restricted cash

 

 

3,654

 

 

 

3,651

 

Other assets

 

 

44

 

 

 

148

 

Total long-term assets

 

 

50,077

 

 

 

44,443

 

Total assets

 

$

181,511

 

 

$

207,007

 

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

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

15,934

 

 

$

7,281

 

Accrued expenses and other current liabilities

 

 

11,056

 

 

 

14,861

 

Current portion of deferred revenue

 

 

32,341

 

 

 

37,098

 

Current portion of operating lease liability

 

 

4,928

 

 

 

4,961

 

Total current liabilities

 

 

64,259

 

 

 

64,201

 

Long-term liabilities:

 

 

 

 

 

 

Deferred revenue, net of current portion

 

 

80,230

 

 

 

77,479

 

Operating lease liability, net of current portion

 

 

33,667

 

 

 

24,955

 

Total long-term liabilities

 

 

113,897

 

 

 

102,434

 

Total liabilities

 

$

178,156

 

 

$

166,635

 

Series A preferred shares, no par value; 3,901,348 shares
   issued and outstanding at September 30, 2022 and December 31, 2021

 

$

7,874

 

 

$

7,874

 

Shareholders’ equity (deficit):

 

 

 

 

 

 

Ordinary shares, no par value; 86,841,523 and 59,841,116 shares
   issued and outstanding at September 30, 2022 and December 31, 2021, respectively

 

$

802,697

 

 

$

749,851

 

Additional paid-in capital

 

 

116,535

 

 

 

87,980

 

Accumulated other comprehensive income (loss)

 

 

(123

)

 

 

181

 

Accumulated deficit

 

 

(923,628

)

 

 

(805,514

)

Total shareholders’ equity (deficit)

 

$

(4,519

)

 

$

32,498

 

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

 

$

181,511

 

 

$

207,007

 

 

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 September 30,

 

 

Nine Months Ended September 30,

 

 

 

2022

 

 

2021

 

 

2022

 

 

2021

 

Revenue

 

$

285

 

 

$

36,423

 

 

$

2,410

 

 

$

39,199

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

27,575

 

 

 

31,086

 

 

 

84,778

 

 

 

96,114

 

General and administrative

 

 

11,609

 

 

 

12,944

 

 

 

36,789

 

 

 

33,991

 

Total operating expenses

 

 

39,184

 

 

 

44,030

 

 

 

121,567

 

 

 

130,105

 

Loss from operations

 

 

(38,899

)

 

 

(7,607

)

 

 

(119,157

)

 

 

(90,906

)

Other income (expense), net:

 

 

 

 

 

 

 

 

 

 

 

 

Dividend income and interest income, net

 

 

596

 

 

 

6

 

 

 

746

 

 

 

25

 

Other income (expense), net

 

 

(701

)

 

 

1,371

 

 

 

297

 

 

 

3,421

 

Total other income (expense), net

 

 

(105

)

 

 

1,377

 

 

 

1,043

 

 

 

3,446

 

Loss before income taxes

 

 

(39,004

)

 

 

(6,230

)

 

 

(118,114

)

 

 

(87,460

)

Income tax provision

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(39,004

)

 

$

(6,230

)

 

$

(118,114

)

 

$

(87,460

)

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

 

$

(0.42

)

 

$

(0.12

)

 

$

(1.60

)

 

$

(1.75

)

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

 

 

93,900,484

 

 

 

50,709,877

 

 

 

73,754,417

 

 

 

50,017,521

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Other comprehensive loss:

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(39,004

)

 

$

(6,230

)

 

$

(118,114

)

 

$

(87,460

)

Foreign currency translation

 

 

(76

)

 

 

(11

)

 

 

(304

)

 

 

(131

)

Comprehensive loss

 

$

(39,080

)

 

$

(6,241

)

 

$

(118,418

)

 

$

(87,591

)

 

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

 

Balance at December 31, 2020

 

 

3,901,348

 

 

$

7,874

 

 

 

 

48,778,678

 

 

$

694,085

 

 

$

71,573

 

 

$

389

 

 

$

(683,269

)

 

$

82,778

 

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

 

 

 

 

 

 

 

 

 

844,796

 

 

 

8,028

 

 

 

 

 

 

 

 

 

 

 

 

8,028

 

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

4,063

 

 

 

 

 

 

 

 

 

4,063

 

Vesting of RSUs

 

 

 

 

 

 

 

 

 

155,184

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Option exercises

 

 

 

 

 

 

 

 

 

31,957

 

 

 

200

 

 

 

 

 

 

 

 

 

 

 

 

200

 

Issuance of ordinary shares
   under the ESPP

 

 

 

 

 

 

 

 

 

44,036

 

 

 

336

 

 

 

 

 

 

 

 

 

 

 

 

336

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(120

)

 

 

 

 

 

(120

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(42,464

)

 

 

(42,464

)

Balance at March 31, 2021

 

 

3,901,348

 

 

$

7,874

 

 

 

 

49,854,651

 

 

$

702,649

 

 

$

75,636

 

 

$

269

 

 

$

(725,733

)

 

$

52,821

 

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

 

 

 

 

 

 

 

 

 

718,179

 

 

 

5,065

 

 

 

 

 

 

 

 

 

 

 

 

5,065

 

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

2,722

 

 

 

 

 

 

 

 

 

2,722

 

Vesting of RSUs

 

 

 

 

 

 

 

 

 

3,636

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(38,766

)

 

 

(38,766

)

Balance at June 30, 2021

 

 

3,901,348

 

 

$

7,874

 

 

 

 

50,576,466

 

 

$

707,714

 

 

$

78,358

 

 

$

269

 

 

$

(764,499

)

 

$

21,842

 

Issuance of ordinary shares,
   net of offering costs

 

 

 

 

 

 

 

 

 

1,345,830

 

 

 

8,082

 

 

 

 

 

 

 

 

 

 

 

 

8,082

 

Share-based compensation

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5,896

 

 

 

 

 

 

 

 

 

5,896

 

Vesting of RSUs

 

 

 

 

 

 

 

 

 

7,485

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Option exercises

 

 

 

 

 

 

 

 

 

20,000

 

 

 

50

 

 

 

 

 

 

 

 

 

 

 

 

50

 

Issuance of ordinary shares
   under the ESPP

 

 

 

 

 

 

 

 

 

48,251

 

 

 

272

 

 

 

 

 

 

 

 

 

 

 

 

272

 

Other comprehensive loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(11

)

 

 

 

 

 

(11

)

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(6,230

)

 

 

(6,230

)

Balance at September 30, 2021

 

 

3,901,348

 

 

$

7,874

 

 

 

 

51,998,032

 

 

$

716,118

 

 

$

84,254

 

 

$

258

 

 

$

(770,729

)

 

$

29,901

 

 

 

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, 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