Lexicon Pharmaceuticals Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Business Updates

Topline Results for Phase 2b PROGRESS Study of Pilavapadin (LX9211) in Diabetic Peripheral Neuropathic Pain (DPNP); 10 mg dose to Advance into Phase 3 Development

Leaner organization focused on Advancing Strong Pipeline

Conference Call and Webcast at 5:00 pm ET 

THE WOODLANDS, Texas, March 06, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months and year ended December 31, 2024, and provided an update on key corporate milestones and accomplishments. 

"In 2024, Lexicon made progress on our Lead to Succeed strategy, resulting in a complete repositioning of the company to focus on advancing our R&D pipeline,” said Mike Exton, Ph.D., Lexicon's chief executive officer and director. "With R&D efforts our core priority, we were pleased to report progress on three programs. First, we recently reported topline results from the PROGRESS Phase 2b study of pilavapadin, our novel non-opioid, oral, investigational therapy for neuropathic pain with potential to be the first new therapy for neuropathic pain in over two decades. We met our study objectives with respect to the 10 mg dose, which achieved meaningful pain reduction versus placebo and was well-tolerated, providing support for initiation of a Phase 3 program for pilavapadin in DPNP in 2025.”

"We are on track for an IND filing this year for LX9851 in obesity and other potential metabolic disorders. In parallel, we continue to build strong differentiating evidence for sotagliflozin, an SGLT1/2 inhibitor, and we are continuing to enroll a Phase 3 clinical trial in support of a potential broad indication in hypertrophic cardiomyopathy (HCM). These three pipeline opportunities are each in areas of significant unmet need, and have the potential for multiple indications, to be first or only new therapy to market, or to be meaningfully differentiated within their market.”

Fourth Quarter 2024 Business and Pipeline Highlights 

Pilavapadin (LX9211) for DPNP 

• Pilavapadin is an orally delivered, small molecule drug candidate for the treatment of DPNP. Pilavapadin has the potential to become the first oral non-opioid drug therapy approved in neuropathic pain in more than 20 years.
• Topline data in PROGRESS met the Company's objective to identify a well-tolerated dose exhibiting meaningful pain reduction that is appropriate to advance into Phase 3 development. In the study, the 10 mg dose arm demonstrated meaningful separation in ADPS from both baseline and placebo and was well-tolerated, although the lack of separation in ADPS between the 20 mg dose arm and placebo resulted in the study not reaching statistical significance on its primary endpoint.
• The Company is moving toward an end of Phase 2 meeting with FDA and targeting initiation of U.S. and ex-U.S. Phase 3 trials in DPNP in 2025, while selecting a future medical meeting for release of additional clinical data later this year.

LX9851 for Obesity and Associated Cardiometabolic Disorders 

• LX9851 is a novel, non-incretin oral development candidate that inhibits ACSL5 and is in preclinical development for obesity and weight management. LX9851 is progressing in IND-enabling studies and on track for a 2025 investigational new drug (IND) application submission.  

Sotagliflozin for HCM 

• Enrollment is underway in SONATA HCM, a pivotal Phase 3 placebo-controlled study with a targeted enrollment of 500 patients with obstructive or nonobstructive hypertrophic cardiomyopathy (HCM). 
• Site initiation in the European Union and Latin America countries are well underway to further support the company's trial execution timelines. All target sites are expected to be up and running by Q3.

INPEFA (sotagliflozin)

• Completed reprioritization of SG&A investment to cease active promotion while continuing to make product commercially available.

Zynquista (sotagliflozin)

• Discontinued preparation for potential Zynquista launch in type 1 diabetes following receipt of complete response letter from FDA.

Data and Publications Highlights

• Continued to focus on generating clinical data to support differentiation of sotagliflozin, including most recent publication in The Lancet Diabetes & Endocrinology analyzing the ability of sotagliflozin to reduce the risks of life-threatening cardiovascular outcomes.
• The findings from the study, "Reduction in Major Adverse Cardiovascular Events with Sotagliflozin: A Prespecified Analysis of the SCORED Randomized Trial,” concluded that the ischemic benefit of sotagliflozin on both heart attack (myocardial infarction, or MI), and stroke reduction has not been observed with other SGLT inhibitors.

Fourth Quarter 2024 Financial Highlights

Revenues: Revenues for the fourth quarter of 2024 increased to $26.6 million from $0.7 million for the comparable period in 2023 and for the full year 2024 increased to $31.1 million from $1.2 million for the full year 2023. Revenues for both periods in 2024 reflect increased sales of INPEFA compared to 2023 and an upfront payment of $25.0 million received upon entering into the Viatris INPEFA licensing agreement in October 2024.

Research and Development (R&D) Expenses: Research and development expenses for the fourth quarter of 2024 increased to $26.7 million from $14.8 million for the comparable period in 2023. Full-year research and development expenses for 2024 increased to $84.5 million from $58.9 million for the full year 2023, primarily due to investments in Phase 2 and 3 clinical trials, including the SONATA Phase 3 study of sotagliflozin in HCM and the PROGRESS Phase 2b study of pilavapadin in DPNP.

Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the fourth quarter of 2024 decreased to $32.3 million from $32.6 million for the comparable period in 2023. Full-year 2024 selling, general and administrative expenses increased to $143.1 million from $114.0 million for the full year 2023. The increase in 2024 reflects higher marketing costs related to the commercialization of INPEFA and increased employee salaries and benefit costs prior to the reduction in our field force in late 2024 including severance costs associated with our strategic repositioning.

Net Loss: Net loss for the fourth quarter of 2024 was $33.8 million, or $0.09 per share, as compared to a net loss of $49.8 million, or $0.20 per share, in the corresponding period in 2023. For the fourth quarters of 2024 and 2023, net loss included non-cash, stock-based compensation expense of $1.5 million and $3.2 million, respectively. Net loss for the full year 2024 was $200.4 million, or $0.63 per share, as compared to a net loss of $177.1 million, or $0.80 per share, for the full year 2023. For the full years of 2024 and 2023, net loss included non-cash, stock-based compensation expense of $13.5 million and $14.3 million, respectively.

Cash and Investments: As of December 31, 2024, Lexicon had $238.0 million in cash and short-term investments, as compared to $170.0 million as of December 31, 2023.

Conference Call and Webcast Information  

Lexicon management will hold a live conference call and webcast today at 5:00 pm ET / 4:00 pm CT to review its financial and operating results and to provide a general business update. A live audio webcast of the call can be accessed by visiting the Events page of the Company's investor relations website at https://investors.lexpharma.com/. Participants who wish to ask a question may register here to receive dial-in numbers and a unique pin to join the call. An archived version of the webcast will be available on the website for 30 days. 

About Lexicon Pharmaceuticals 

Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients' lives. Through the Genome5000™ program, Lexicon's unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to safely and effectively treat disease. Lexicon has advanced multiple medicines to market and has a pipeline of promising drug candidates in discovery and clinical and preclinical development in heart failure, neuropathic pain, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com. 

Safe Harbor Statement 

This press release contains "forward-looking statements,” including statements relating to Lexicon's financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of its other drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon's growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon's ability to meet its capital requirements, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under "Risk Factors” in Lexicon's annual report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.