Wave Life Sciences Reports First Quarter 2024 Financial Results and Provides Business Update

Wave Life Sciences USA, Inc.

RestorAATion-2 clinical trial of WVE-006 in AATD patients underway; expected proof-of-mechanism data in patients with AATD remains on track for 2024

INHBE program for obesity expected clinical trial initiation in 1Q 2025; preclinical data demonstrate weight loss similar to semaglutide, fat loss with no loss of muscle mass, and curtailed rebound weight gain upon cessation of semaglutide, with potential for dosing 1 – 2 times per year

Continued momentum in GSK collaboration; advancing first two GSK collaboration programs following successful target validation; both programs utilize Wave’s GalNAc-siRNA format and discovery collaboration continues to span all Wave modalities, including RNA editing

Clinical data on track for first-in-class, allele-selective HD program (expected 2Q 2024) and potentially registrational FORWARD-53 trial in DMD (expected 3Q 2024)

Cash and cash equivalents of $181 million as of March 31, 2024; with an additional $12 million aggregate initiation payment earned under GSK collaboration subsequent to quarter-end for advancement of programs; runway expected into 4Q 2025

Investor conference call and webcast at 8:30 a.m. ET today

CAMBRIDGE, Mass., May 09, 2024 (GLOBE NEWSWIRE) — Wave Life Sciences Ltd. (Nasdaq: WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health, today announced financial results for the first quarter ended March 31, 2024, and provided a business update.

“Since our last update, we have made excellent progress across our multimodal pipeline of novel RNA medicines and continued to advance our collaboration with GSK. We are on-track to deliver key data sets this year, which enable opportunities to unlock the broad potential of our RNA editing, silencing and splicing capabilities,” said Paul Bolno, MD, MBA, President and Chief Executive Officer of Wave Life Sciences. “In RNA editing, we are advancing WVE-006, having used data from healthy volunteers in RestorAATion-1 to identify a starting dose in our RestorAATion-2 study that is expected to engage target in patients. With RestorAATion-2 now underway, we remain on track to deliver expected proof of mechanism data in patients with AATD this year, which would represent the first-ever clinical demonstration of RNA editing and be an important milestone for the alpha-1 community, as well as serve to validate our wholly owned RNA editing pipeline.”

Dr. Bolno continued, “In addition to pioneering the field of RNA editing, we are working expeditiously to advance our GalNAc-siRNA INHBE program in obesity and expect to initiate a clinical trial in the first quarter of next year. In DMD and HD, we are approaching clinical data readouts as we plan to deliver multidose data for our allele-selective HD program in the second quarter and potentially registrational data from our FORWARD-53 trial in DMD in the third quarter. Our efforts to accelerate development of our INHBE program and advance our pipeline and collaborations have laid a strong foundation for Wave’s future and we look forward to demonstrating our leadership in RNA medicines as we reimagine what’s possible for science, for medicine, and for human health.”

Recent Business Highlights

AATD and AIMer pipeline (RNA editing)

Obesity (siRNA)

GSK Collaboration

DMD (exon skipping)

HD (antisense silencing)

Corporate

  • Dr. Erik Ingelsson appointed CSO; builds on Wave’s recent progress advancing innovative genetic targets and adds experience to accelerate rapid identification and translation of unique genetic insights

    • Today, Wave announced the appointment of Erik Ingelsson, MD, PhD, as Chief Scientific Officer (CSO). Dr. Ingelsson joins Wave to drive the emerging therapeutic portfolio strategy, including growing its genetics and genomics capabilities for identifying new, high impact targets and leveraging Wave’s multimodal platform to advance transformative RNA medicines. Dr. Ingelsson brings deep expertise in genetics and drug discovery, as well as substantial experience in metabolic diseases, such as obesity, MASH and cardiovascular disease.

    • Most recently, Dr. Ingelsson served as Senior Vice President, Head of Target Discovery, at GSK, and prior to that, was SVP of Genomic Sciences at GSK. Previously, he was a Professor of Medicine at Stanford University. (See May 9, 2024 press release here)

Financial Highlights

  • Cash and cash equivalents were $180.9 million as of March 31, 2024, compared to $200.4 million as of December 31, 2023. Subsequent to March 31, 2024, GSK advanced two programs to candidate development, triggering a $12.0 million aggregate initiation payment to Wave. Wave expects that its current cash and cash equivalents will be sufficient to fund operations into the fourth quarter of 2025. Potential future milestone and other payments to Wave under its GSK and Takeda collaborations are not included in its cash runway.

  • Revenue was $12.5 million for the first quarter of 2024, as compared to $12.9 million in the first quarter of 2023. The slight decrease in revenue was due to decreased revenue from the Takeda collaboration. Revenue from the GSK collaboration was consistent for the first quarter of 2024 and 2023.

  • Research and development expenses were $33.4 million in the first quarter of 2024, as compared to $31.0 million in the first quarter of 2023. General and administrative expenses were $13.5 million in the first quarter of 2024, as compared to $12.2 million in the first quarter of 2023.

  • Net loss was $31.6 million for the first quarter of 2024, as compared to $27.4 million for the first quarter of 2023.

Investor Conference Call and Webcast
Wave will host an investor conference call today at 8:30 a.m. ET to review the first quarter 2024 financial results and pipeline updates. A webcast of the conference call can be accessed by visiting “Investor Events” on the investor relations section of the Wave Life Sciences website: https://ir.wavelifesciences.com/events-publications/events. Analysts planning to participate during the Q&A portion of the live call can join the conference call at the following audio-conferencing link: available here. Once registered, participants will receive the dial-in information. Following the live event, an archived version of the webcast will be available on the Wave Life Sciences website.

About Wave Life Sciences
Wave Life Sciences (Nasdaq: WVE) is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Wave’s RNA medicines platform, PRISM®, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Its toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing Wave with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Wave’s diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a preclinical program in obesity. Driven by the calling to “Reimagine Possible”, Wave is leading the charge toward a world in which human potential is no longer hindered by the burden of disease. Wave is headquartered in Cambridge, MA. For more information on Wave’s science, pipeline and people, please visit www.wavelifesciences.com and follow Wave on X (formerly Twitter) and LinkedIn.

Forward-Looking Statements
This press release contains forward-looking statements concerning our goals, beliefs, expectations, strategies, objectives and plans, and other statements that are not necessarily based on historical facts, including statements regarding the following, among others: the anticipated initiation, site activation, patient recruitment, patient enrollment, dosing, generation and reporting of data and completion of our clinical trials, including interactions with regulators and any potential registration based on these data, and the announcement of such events; the protocol, design and endpoints of our clinical trials; the future performance and results of our programs in clinical trials; ongoing and future preclinical activities and programs; regulatory submissions; the progress and potential benefits of our collaborations; the potential achievement of milestones under our collaborations and receipt of cash payments therefor; the potential of our preclinical data to predict the behavior of our compounds in humans; our identification and expected timing of future product candidates and their therapeutic potential; the anticipated benefits of our therapeutic candidates and pipeline compared to our competitors; our ability to design compounds using various modalities and the anticipated benefits of that approach; the breadth and versatility of our PRISM drug discovery and development platform; the expected benefits of our stereopure oligonucleotides compared with stereorandom oligonucleotides; the potential benefits of our RNA editing capability, including our AIMers, compared to others; the potential for certain of our programs to be best-in-class or first-in-class; the potential benefits of our GalNAc-conjugated siRNA program targeting INHBE; the potential benefits that our “edit-verse” may provide us, including identifying new RNA editing targets; the status and progress of our programs relative to potential competitors; anticipated benefits of our proprietary manufacturing processes and our internal manufacturing capabilities; the benefits of RNA medicines generally; the strength of our intellectual property and the data that support our IP; the anticipated duration of our cash runway and our ability to fund future operations; our intended uses of capital; and our expectations regarding the impact of any potential global macro events on our business. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including the following: our ability to finance our drug discovery and development efforts and to raise additional capital when needed; the ability of our preclinical programs to produce data sufficient to support our clinical trial applications and the timing thereof; the clinical results of our programs and the timing thereof, which may not support further development of our product candidates; actions of regulatory authorities and their receptiveness to our adaptive trial designs, which may affect the initiation, timing and progress of clinical trials; our effectiveness in managing regulatory interactions and future clinical trials; the effectiveness of PRISM; the effectiveness of our RNA editing capability and our AIMers; our ability to demonstrate the therapeutic benefits of our candidates in clinical trials, including our ability to develop candidates across multiple therapeutic modalities; our dependence on third parties, including contract research organizations, contract manufacturing organizations, collaborators and partners; our ability to manufacture or contract with third parties to manufacture drug material to support our programs and growth; our ability to obtain, maintain and protect our intellectual property; our ability to enforce our patents against infringers and defend our patent portfolio against challenges from third parties; competition from others developing therapies for the indications we are pursuing; our ability to maintain the company infrastructure and personnel needed to achieve our goals; and the information under the caption “Risk Factors” contained in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) and in other filings we make with the SEC from time to time. We undertake no obligation to update the information contained in this press release to reflect subsequently occurring events or circumstances.

WAVE LIFE SCIENCES LTD.
UNAUDITED CONSOLIDATED BALANCE SHEETS

 

(In thousands, except share amounts)

 

 

 

March 31,
2024

 

 

December 31,
2023

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

180,922

 

 

$

200,351

 

Accounts receivable

 

 

 

 

 

21,086

 

Prepaid expenses

 

 

11,139

 

 

 

9,912

 

Other current assets

 

 

4,706

 

 

 

4,024

 

Total current assets

 

 

196,767

 

 

 

235,373

 

Long-term assets:

 

 

 

 

 

 

Property and equipment, net of accumulated depreciation of $43,687 and $42,709
as of March 31, 2024 and December 31, 2023, respectively

 

 

12,418

 

 

 

13,084

 

Operating lease right-of-use assets

 

 

21,502

 

 

 

22,637

 

Restricted cash

 

 

3,715

 

 

 

3,699

 

Other assets

 

 

868

 

 

 

156

 

Total long-term assets

 

 

38,503

 

 

 

39,576

 

Total assets

 

$

235,270

 

 

$

274,949

 

Liabilities, Series A preferred shares, and shareholders’ equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

11,730

 

 

$

12,839

 

Accrued expenses and other current liabilities

 

 

6,621

 

 

 

16,828

 

Current portion of deferred revenue

 

 

140,586

 

 

 

150,059

 

Current portion of operating lease liability

 

 

6,936

 

 

 

6,714

 

Total current liabilities

 

 

165,873

 

 

 

186,440

 

Long-term liabilities:

 

 

 

 

 

 

Deferred revenue, net of current portion

 

 

12,536

 

 

 

15,601

 

Operating lease liability, net of current portion

 

 

23,598

 

 

 

25,404

 

Total long-term liabilities

 

 

36,134

 

 

 

41,005

 

Total liabilities

 

$

202,007

 

 

$

227,445

 

Series A preferred shares, no par value; 3,901,348 shares
issued and outstanding at March 31, 2024 and December 31, 2023

 

$

7,874

 

 

$

7,874

 

Shareholders’ equity:

 

 

 

 

 

 

Ordinary shares, no par value; 122,321,384 and 119,162,234 shares
issued and outstanding at March 31, 2024 and December 31, 2023, respectively

 

$

949,877

 

 

$

935,367

 

Additional paid-in capital

 

 

132,118

 

 

 

129,237

 

Accumulated other comprehensive loss

 

 

(198

)

 

 

(124

)

Accumulated deficit

 

 

(1,056,408

)

 

 

(1,024,850

)

Total shareholders’ equity

 

$

25,389

 

 

$

39,630

 

Total liabilities, Series A preferred shares, and shareholders’ equity

 

$

235,270

 

 

$

274,949

 

WAVE LIFE SCIENCES LTD.
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

 

(In thousands, except share and per share amounts)

 

 

 

Three Months Ended
March 31,

 

 

 

2024

 

 

2023

 

Revenue

 

$

12,538

 

 

$

12,929

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

 

33,447

 

 

 

30,979

 

General and administrative

 

 

13,549

 

 

 

12,235

 

Total operating expenses

 

 

46,996

 

 

 

43,214

 

Loss from operations

 

 

(34,458

)

 

 

(30,285

)

Other income, net:

 

 

 

 

 

 

Dividend income and interest income

 

 

2,535

 

 

 

1,873

 

Other income, net

 

 

365

 

 

 

1,007

 

Total other income, net

 

 

2,900

 

 

 

2,880

 

Loss before income taxes

 

 

(31,558

)

 

 

(27,405

)

Income tax benefit (provision)

 

 

 

 

 

 

Net loss

 

$

(31,558

)

 

$

(27,405

)

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

 

$

(0.24

)

 

$

(0.27

)

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

 

 

129,271,678

 

 

 

102,056,712

 

Other comprehensive loss:

 

 

 

 

 

 

Net loss

 

$

(31,558

)

 

$

(27,405

)

Foreign currency translation

 

 

(74

)

 

 

(21

)

Comprehensive loss

 

$

(31,632

)

 

$

(27,426

)

 

Investor Contact:
Kate Rausch
+1 617-949-4827
[email protected]

Media Contact:
Alicia Suter
+1 617-949-4817
[email protected]

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