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Wave Life Sciences .(WVE) - 2024 Q2 - Quarterly Report
2024-08-08 11:55
Clinical Development - The company initiated the RestorAATion clinical program for WVE-006 in Q4 2023, targeting Alpha-1 antitrypsin deficiency (AATD) with a focus on restoring wild-type AAT protein levels in serum [51]. - WVE-006 achieved serum AAT protein levels of up to 30 micromolar in preclinical models, restoring approximately 50% wild-type M-AAT protein and demonstrating a 3-fold increase in neutrophil elastase inhibition activity [53]. - The company is advancing WVE-007, a GalNAc-siRNA targeting INHBE for obesity, with preclinical data showing significant weight loss and fat reduction in diet-induced obesity models [54]. - WVE-N531 is designed to skip exon 53 in the dystrophin gene, addressing approximately 8-10% of Duchenne muscular dystrophy (DMD) cases, with positive proof-of-concept data from early trials [56]. - The Phase 2 trial for WVE-N531 (FORWARD-53) has been initiated, with results expected in Q3 2024, focusing on dystrophin protein levels and safety [58]. - WVE-003 is being developed for Huntington's disease, targeting a specific SNP associated with the disease, with the potential to address up to 80% of the HD population in future [59]. - The SELECT-HD trial showed a statistically significant reduction of up to 46% in cerebrospinal fluid mHTT levels with WVE-003, indicating potential benefits for early-stage HD patients [63]. Financial Performance - For the three months ended June 30, 2024, the company reported a net loss of $32.9 million, compared to a net loss of $21.1 million for the same period in 2023, reflecting an increase of $11.8 million [67]. - Total operating expenses for Q2 2024 were $54.7 million, up from $45.6 million in Q2 2023, marking an increase of $9.1 million [77]. - Research and development expenses rose to $40.4 million in Q2 2024, compared to $33.3 million in Q2 2023, an increase of approximately $7.1 million [82]. - The company has an accumulated deficit of $1,089.3 million as of June 30, 2024, up from $1,024.9 million at the end of 2023 [67]. - Revenue for the six months ended June 30, 2024, was $32.2 million, a decrease of approximately 8.1% from $35.0 million in the same period of 2023 [84]. - Total operating expenses increased to $101.7 million in the first half of 2024, up from $88.8 million in 2023, representing a rise of approximately 14.5% [84]. - Research and development expenses rose to $73.8 million in the first half of 2024, an increase of about 14.8% compared to $64.3 million in 2023 [84]. - General and administrative expenses were $27.8 million for the six months ended June 30, 2024, up from $24.5 million in 2023, reflecting an increase of approximately 13.5% [85]. - Net loss for the six months ended June 30, 2024, was $64.5 million, compared to a net loss of $48.5 million in 2023, indicating an increase in loss of approximately 33.0% [84]. - Cash and cash equivalents totaled $154.0 million as of June 30, 2024, with an accumulated deficit of $1,089.3 million [88]. - Net cash used in operating activities was $60.9 million for the six months ended June 30, 2024, compared to a net cash provided of $48.3 million in 2023 [89]. - Net cash provided by financing activities was $15.2 million in the first half of 2024, down from $36.9 million in the same period of 2023 [92]. Collaborations and Partnerships - The collaboration with GlaxoSmithKline (GSK) includes potential milestone payments of up to $525 million and double-digit tiered royalties for WVE-006, with a $20 million milestone payment already achieved [52]. - GSK selected two programs for development candidates, triggering a $12 million initiation payment [66]. - The GSK collaboration agreement generated revenue of $19.7 million in Q2 2024, a decrease from $22.1 million in Q2 2023 [78]. Future Outlook and Risks - The company expects to continue incurring significant operating losses and expenses in the foreseeable future [67]. - The company has not generated any product revenue since inception and does not expect to do so in the near future [68]. - The company anticipates continued significant expenses related to ongoing research and development activities and internal manufacturing [93]. - The company may face delays and issues in drug candidate development due to various risks, including regulatory challenges and safety issues [95]. - Future capital requirements for therapeutic programs will depend on research progress, costs, and the number of product candidates pursued [95]. - The company currently has no committed external funding sources, relying on potential future payments from collaborations with Takeda and GSK [95]. - The company is exposed to interest rate risk due to fluctuations in interest rates affecting cash and cash equivalents [97]. - Foreign currency exchange rate changes could materially impact the company's financial condition, although no significant effects were noted in the past two years [98]. - Inflation trends may lead to increased clinical trial, labor, and operating costs in the future [99]. - The company has no product revenues and relies on funds raised through equity offerings, which are influenced by capital market conditions [100]. Research and Development Strategy - The company maintains a robust pipeline of RNA-targeting modalities, leveraging novel chemistry to enhance the pharmacological properties of oligonucleotides [46]. - The company’s RNA medicines platform, PRISM®, combines multiple modalities and deep insights into human genetics to address both rare and prevalent disorders [46]. - The strategic focus on oligonucleotides allows the company to avoid risks associated with DNA editing and gene therapy, while leveraging established manufacturing processes [47].
Wave Life Sciences .(WVE) - 2024 Q1 - Quarterly Report
2024-05-10 11:30
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 March 31, 2024 ☐ 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 juris ...
Wave Life Sciences .(WVE) - 2024 Q1 - Quarterly Results
2024-05-09 11:37
Exhibit 99.1 Wave Life Sciences Reports First Quarter 2024 Financial Results and Provides Business Update 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 f ...
Wave Life Sciences .(WVE) - 2023 Q4 - Earnings Call Transcript
2024-03-06 17:03
Wave Life Sciences Ltd. (NASDAQ:WVE) Q4 2023 Earnings Call Transcript March 6, 2024 8:30 AM ET Company Participants Kate Rausch - Vice President, Investor Relations & Corporate Affairs Paul Bolno - President & Chief Executive Officer Anne-Marie Li-Kwai-Cheung - Chief Development Officer Kyle Moran - Chief Financial Officer Conference Call Participants Timur Ivannikov - Raymond James Salim Syed - Mizuho Joon Lee - Truist Joseph Schwartz - Leerink Partners Luca Issi - RBC Capital Andrew Fein - H.C. Wainwright ...
Wave Life Sciences .(WVE) - 2023 Q4 - Annual Report
2024-03-06 12:55
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 ☐ 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. 001-37627 WAVE LIFE SCIENCES LTD. (Exact name of registrant as specified in its charter) Singapore 98-1356880 (State or other jurisdiction of i ...
Wave Life Sciences .(WVE) - 2023 Q4 - Annual Results
2024-03-06 12:39
Financial Performance - Revenue for the fourth quarter of 2023 was $29.1 million, a significant increase from $1.2 million in the prior year quarter, with total revenue for 2023 reaching $113.3 million compared to $3.6 million in 2022[13] - Total revenue for Q4 2023 reached $29,056 thousand, a significant increase from $1,239 thousand in Q4 2022, representing a growth of 2,241%[18] - For the full year 2023, revenue was $113,305 thousand, up from $3,649 thousand in 2022, marking a growth of 3,008%[18] - The net loss for Q4 2023 was $16.3 million, significantly improved from a net loss of $43.7 million in the prior year quarter, with a total net loss of $57.5 million for 2023 compared to $161.8 million in 2022[13] - The net loss for Q4 2023 was $16,256 thousand, an improvement from a net loss of $43,709 thousand in Q4 2022, indicating a reduction of 63%[18] - The comprehensive loss for the full year 2023 was $57,608 thousand, a decrease from $162,033 thousand in 2022, showing a reduction of 64%[18] Research and Development - Research and development expenses were $34.1 million in Q4 2023, up from $31.1 million in Q4 2022, with total R&D expenses for 2023 at $130.0 million compared to $115.9 million in 2022[13] - Research and development expenses for the full year 2023 totaled $130,009 thousand, up from $115,856 thousand in 2022, reflecting a 12% increase[18] - Wave anticipates delivering proof-of-mechanism data for WVE-006 in AATD in 2024, which would unlock its pipeline of RNA editing candidates[6] - The FORWARD-53 trial for WVE-N531 in DMD is on track to deliver data, including dystrophin protein expression, in the third quarter of 2024, with industry-leading exon skipping levels of 53% reported[9] - WVE-003 has demonstrated a 35% reduction in mean mutant HTT in cerebrospinal fluid compared to placebo, with ongoing multi-dose evaluations expected to report data in Q2 2024[9] - The company expects to initiate a clinical trial for its INHBE candidate in the first quarter of 2025, with a potentially best-in-class profile for obesity[9] Cash and Assets - Cash and cash equivalents were $200.4 million as of December 31, 2023, compared to $88.5 million as of December 31, 2022, primarily due to $170.0 million received from the GSK collaboration and $93.6 million in net proceeds from the December 2023 offering[13] - Wave's current cash and cash equivalents are expected to fund operations into the fourth quarter of 2025, excluding potential future milestone payments[13] - The total assets as of December 31, 2023, were $274,949 thousand, compared to $146,386 thousand as of December 31, 2022, an increase of 87%[16] Liabilities and Equity - Current liabilities increased to $186,440 thousand in 2023 from $71,521 thousand in 2022, a rise of 161%[16] - Shareholders' equity improved to $39,630 thousand in 2023 from a deficit of $45,091 thousand in 2022, indicating a positive shift[16] Milestones and Payments - The company received a $20 million milestone payment from GSK in Q4 2023 following the initiation of dosing in the RestorAATion-1 clinical trial[6] - The company reported a weighted-average of 109,627,549 ordinary shares used in computing net loss per share for Q4 2023, compared to 93,993,638 in Q4 2022[18]
Wave Life Sciences .(WVE) - 2023 Q3 - Earnings Call Transcript
2023-11-10 17:04
Wave Life Sciences Ltd. (NASDAQ:WVE) Q3 2023 Earnings Conference Call November 9, 2023 8:30 AM ET Company Participants Kate Rausch - Vice President, Investor Relations & Corporate Affairs Paul Bolno - President & Chief Executive Officer Anne-Marie Li-Kwai-Cheung - Chief Development Officer Kyle Moran - Chief Financial Officer Conference Call Participants Steve Seedhouse - Raymond James Salim Syed - Mizuho Joseph Schwartz - Leerink Partners Eun Yang - Jefferies Operator Good morning and welcome to Wave Life ...
Wave Life Sciences .(WVE) - 2023 Q3 - Quarterly Report
2023-11-09 12:55
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, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ Singapore (State or other jurisdiction of incorporation or organization) 7 Straits View #12-00, Marina One East Tower Singapore Commission F ...
Wave Life Sciences .(WVE) - 2023 Q2 - Earnings Call Transcript
2023-08-06 07:14
Wave Life Sciences Ltd. (NASDAQ:WVE) Q2 2023 Earnings Conference Call August 3, 2023 8:30 AM ET Company Participants Kate Rausch - Head of Investor Relations Paul Bolno - President and Chief Executive Officer Anne Cheung - Chief Development Officer Kyle Moran - CFO Conference Call Participants Steven Seedhouse - Raymond James Julian Pino - Stifel Eun Yang - Jefferies Salim Syed - Mizuho Operator Good morning, and welcome to the Wave Life Sciences Second Quarter 2023 Financial Results Conference Call. [Opera ...
Wave Life Sciences .(WVE) - 2023 Q2 - Quarterly Report
2023-08-03 11:56
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 June 30, 2023 ☐ 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 jurisd ...