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NDA for Sotagliflozin Remains on Track for May 2023 PDUFA Date Following Mid-Cycle Review Meeting
Final Data from Successful RELIEF-DPN-1 Study of LX9211 in Painful Diabetic Neuropathy to Be Presented at 16thAnnual Pain Therapeutics Summit Next Week
Conference Call and Webcast at 5:00 pm Eastern Time
THE WOODLANDS, Texas, Nov. 09, 2022 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months ended September 30, 2022 and provided an update on key corporate milestones.
“Our mid-cycle review meeting with the FDA was held this week for our NDA for sotagliflozin for the treatment of heart failure, which remains on track for its PDUFA action date in May 2023,” said Lonnel Coats, Lexicon’s chief executive officer. “This past weekend, important data for sotagliflozin were presented at two major medical conferences, notably including an oral presentation at the American Heart Association Scientific Sessions 2022 on reduced cardiovascular mortality and hospital readmissions for heart failure at 30- and 90-days post discharge in patients hospitalized for worsening heart failure in the SOLOIST-WHF trial.”
“This coming Monday, final data from our successful RELIEF-DPN-1 study of LX9211 in painful diabetic neuropathy will be presented at the 16th Annual Pain Therapeutics Summit in Washington, D.C., which we will follow with a conference call discussing the results and their importance in an area of significant unmet need,” Mr. Coats continued. “Finally, we completed enrollment earlier this quarter in our RELIEF-PHN-1 study of LX9211 in post-herpetic neuralgia, from which we expect to report top-line data before year-end.”
Third Quarter Highlights
Sotagliflozin
LX9211
Public Offering and Concurrent Private Placement
Third Quarter 2022 Financial Highlights
Research and Development (R&D) Expenses: Research and development expenses for the third quarter of 2022 decreased to $10.6 million from $15.7 million for the corresponding period in 2021, primarily due to lower clinical external research expenses and professional and consulting costs.
Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the third quarter of 2022 increased to $12.6 million from $7.3 million for the corresponding period in 2021, primarily due to increases in salaries and benefits, professional and consulting costs and marketing costs relating to preparations for the commercial launch of sotagliflozin.
Net Loss: Net loss for the third quarter of 2022 was $23.4 million, or $0.13 per share, as compared to a net loss of $23.1 million, or $0.16 per share, in the corresponding period in 2021. For the third quarters of 2022 and 2021, net loss included non-cash, stock-based compensation expense of $2.6 million and $2.7 million, respectively.
Cash and Investments: As of September 30, 2022, Lexicon had $136.2 million in cash and investments, as compared to $86.7 million as of December 31, 2021
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. The dial-in number for the conference call is 888-886-7786 and the conference ID for all callers is 70766912. The live webcast and replay may be accessed by visiting Lexicon’s website at www.lexpharma.com/events. An archived version of the webcast will be available on the website for 14 days.
About Lexicon Pharmaceuticals
Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through its Genome5000™ program, 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 advanced one of these 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 clinical development of, regulatory filings for, and potential therapeutic and commercial potential of sotagliflozin, LX9211 and its other potential drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery and development 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 conduct preclinical and clinical development and obtain necessary regulatory approvals of sotagliflozin, LX9211 and its other potential drug candidates on its anticipated timelines, successfully commercialize any products for which it obtains regulatory approval, 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 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, 2021, 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. Lexicon Pharmaceuticals, Inc.Selected Financial Data Consolidated Statements of Operations Data Three Months Ended September 30,
Nine Months Ended September 30,(In thousands, except per share data) 2022 2021 2022 2021 (Unaudited)
(Unaudited)Revenues: Royalties and other revenue $39 $23 $111 $284 Operating expenses: Research and development, including stock-based compensation of $939, $1,138, $3,069 and $3,608, respectively 10,557 15,682 38,839 38,548 Selling, general and administrative, including stock-based compensation of $1,709, $1,574, $5,183 and $4,741, respectively 12,577 7,303 31,754 23,496 Total operating expenses 23,134 22,985 70,593 62,044 Loss from operations (23,095) (22,962) (70,482) (61,760)Interest expense (864) (171) (1,677) (507)Interest and other income, net 572 11 709 120 Net loss $(23,387) $(23,122) $(71,450) $(62,147) Net loss per common share, basic and diluted $(0.13) $(0.16) $(0.45) $(0.43) Shares used in computing net loss per common share, basic and diluted 174,904 145,820 157,984 144,558 As ofAs ofConsolidated Balance Sheet Data September 30, 2022
December 31, 2021
(In thousands) Cash and investments $136,203 $86,743 Property and equipment, net 932 1,176 Goodwill 44,543 44,543 Total assets 191,685 136,909 Long-term debt, net of issuance costs 23,784 - Accumulated deficit (1,559,226) (1,487,776)Total stockholders' equity 144,018 113,595
For Inquiries:
Mike Kelly
Lexicon Pharmaceuticals, Inc.
mkelly@lexpharma.com