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New Post-Hoc Analysis of Pooled Phase 3 Data Shows That INPEFA® (Sotagliflozin) Reduced Risk of Heart Failure Events in Patients With Preserved Ejection Fraction
Newsfilter· 2024-05-14 11:00
THE WOODLANDS, Texas, May 14, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced a new post-hoc analysis of clinical data showing that INPEFA® (sotagliflozin), a dual oral inhibitor of SGLT2 and SGLT1, reduced the risk of heart failure-related events across a diverse population of patients, including patients with preserved ejection fraction (HFpEF). Researchers noted that INPEFA appeared to be particularly effective in reducing the risk of heart failure events in patients ...
Lexicon Pharmaceuticals(LXRX) - 2024 Q1 - Quarterly Report
2024-05-02 20:08
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 or ☐ 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: 000-30111 Lexicon Pharmaceuticals, Inc. (Exact Name of Registrant as Specified in its Charter) | Title ...
Lexicon Pharmaceuticals(LXRX) - 2024 Q1 - Quarterly Results
2024-05-02 20:07
[Corporate Highlights and Outlook](index=1&type=section&id=Corporate%20Highlights%20and%20Outlook) Lexicon Pharmaceuticals reported Q1 2024 progress with INPEFA's launch, pipeline advancements, and strong capitalization - The commercial launch of INPEFA for heart failure is progressing, with an expected inflection in the second half of 2024 driven by expanded market access[1](index=1&type=chunk)[3](index=3&type=chunk) - Planning to resubmit the New Drug Application (NDA) for ZYNQUISTA™ for type 1 diabetes with chronic kidney disease (CKD) around mid-year 2024[1](index=1&type=chunk)[3](index=3&type=chunk) - A Phase 3 study of sotagliflozin in hypertrophic cardiomyopathy (HCM) is starting, with enrollment expected to begin mid-year 2024[1](index=1&type=chunk)[3](index=3&type=chunk) - Enrollment is on track for the Phase 2b PROGRESS study of LX9211 for diabetic peripheral neuropathic pain, with topline data expected in Q2 2025[1](index=1&type=chunk)[3](index=3&type=chunk) - Selected LX9851 as a new development candidate for obesity and weight management, now entering IND-enabling studies[3](index=3&type=chunk) - The company is well-capitalized following a recent successful financing, enabling targeted investments for growth[3](index=3&type=chunk) [Pipeline Highlights](index=1&type=section&id=Pipeline%20Highlights) Lexicon's pipeline demonstrated strong Q1 2024 momentum with significant progress across its key drug candidates [INPEFA (sotagliflozin) for Heart Failure](index=1&type=section&id=INPEFA%20%28sotagliflozin%29%20for%20Heart%20Failure) INPEFA's commercial launch progressed in Q1 2024, showing significant sales growth and anticipated market access expansion | Metric | Value | | :--- | :--- | | Q1 2024 Net Sales | $1.1 million | | QoQ Growth | 63% | | Current Market Access | ~40% | [ZYNQUISTA (sotagliflozin) for Type 1 Diabetes](index=1&type=section&id=ZYNQUISTA%20%28sotagliflozin%29%20for%20Type%201%20Diabetes) Lexicon plans mid-2024 NDA resubmission for ZYNQUISTA as adjunctive therapy for type 1 diabetes with CKD - NDA resubmission for ZYNQUISTA is planned for mid-year 2024 as an adjunct to insulin for people with type 1 diabetes and CKD[5](index=5&type=chunk) - Chronic kidney disease (CKD) is estimated to impact **20% to 25%** of people with type 1 diabetes[6](index=6&type=chunk) [Sotagliflozin for HCM](index=2&type=section&id=Sotagliflozin%20for%20HCM) Lexicon is initiating a Phase 3 study of sotagliflozin for hypertrophic cardiomyopathy (HCM), expected mid-year 2024 - A Phase 3 study of sotagliflozin in HCM is being initiated, with study start expected mid-year 2024[7](index=7&type=chunk) [LX9211 for DPNP](index=2&type=section&id=LX9211%20for%20DPNP) Enrollment for LX9211's Phase 2b DPNP study is on track, with topline data anticipated in Q2 2025 - The PROGRESS Phase 2b study of LX9211 is on track, with topline data anticipated in Q2 2025[8](index=8&type=chunk) [LX9851 for Obesity and Weight Management](index=2&type=section&id=LX9851%20for%20Obesity%20and%20Weight%20Management) Lexicon selected LX9851, an oral ACSL5-inhibitor, as a development candidate for obesity, now entering IND-enabling studies - LX9851, an oral ACSL5-inhibitor, has been selected as a development candidate for obesity and is now commencing IND-enabling studies[9](index=9&type=chunk) [First Quarter 2024 Financial Highlights](index=2&type=section&id=First%20Quarter%202024%20Financial%20Highlights) Lexicon's Q1 2024 financials show **$1.1 million** revenue, a **$48.4 million** net loss, and a **$355.6 million** cash position | Financial Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Total Revenues | $1.1 million | $0.02 million | | R&D Expenses | $14.4 million | $12.0 million | | SG&A Expenses | $32.1 million | $19.1 million | | Net Loss | $(48.4) million | $(31.9) million | | Net Loss per Share | $(0.20) | $(0.17) | | Cash and Investments (End of Period) | $355.6 million | N/A | [Selected Financial Data](index=6&type=section&id=Selected%20Financial%20Data) This section provides Lexicon's unaudited consolidated statements of operations and balance sheet data for Q1 2024 Consolidated Statements of Operations Data (Unaudited, In thousands, except per share data) | | Three Months Ended March 31, | | :--- | :---: | :---: | | | **2024** | **2023** | | **Total revenues** | **$1,130** | **$24** | | Cost of sales | $31 | $— | | Research and development | $14,372 | $12,026 | | Selling, general and administrative | $32,060 | $19,140 | | **Total operating expenses** | **$46,463** | **$31,166** | | Loss from operations | $(45,333) | $(31,142) | | **Net loss** | **$(48,397)** | **$(31,934)** | | Net loss per common share | $(0.20) | $(0.17) | Consolidated Balance Sheet Data (Unaudited, In thousands) | | As of March 31, 2024 | As of December 31, 2023 | | :--- | :---: | :---: | | **Cash and investments** | **$355,598** | **$170,026** | | Total assets | $417,219 | $229,429 | | Long-term debt, net | $99,874 | $99,508 | | **Total stockholders' equity** | **$288,867** | **$93,110** | [About INPEFA (sotagliflozin)](index=3&type=section&id=About%20INPEFA%20%28sotagliflozin%29) INPEFA (sotagliflozin) is an oral SGLT1/SGLT2 inhibitor indicated for cardiovascular risk reduction in heart failure and type 2 diabetes, with safety warnings - INPEFA is an oral inhibitor of both SGLT1 (gastrointestinal tract) and SGLT2 (kidney), which regulate glucose and sodium[17](index=17&type=chunk) - Indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure or type 2 diabetes with CKD and other CV risk factors[18](index=18&type=chunk)[21](index=21&type=chunk) - Key safety risks include ketoacidosis, volume depletion (especially in patients with impaired renal function or on loop diuretics), urosepsis, hypoglycemia (when used with insulin), necrotizing fasciitis of the perineum, and genital mycotic infections[20](index=20&type=chunk)[22](index=22&type=chunk)[23](index=23&type=chunk) - Common adverse reactions (≥5% incidence) include urinary tract infection, volume depletion, diarrhea, and hypoglycemia[26](index=26&type=chunk) [About Lexicon Pharmaceuticals and Safe Harbor](index=5&type=section&id=About%20Lexicon%20Pharmaceuticals%20and%20Safe%20Harbor) Lexicon Pharmaceuticals is a biopharmaceutical company leveraging its Genome5000™ platform, with a Safe Harbor statement on forward-looking statements - Lexicon's mission is to pioneer medicines using its unique Genome5000™ genomics target discovery platform[29](index=29&type=chunk) - The press release contains forward-looking statements based on current expectations, which are subject to risks and uncertainties that could cause actual results to differ materially[30](index=30&type=chunk)
Lexicon Pharmaceuticals to Host First Quarter 2024 Financial Results Conference Call and Webcast on May 2, 2024
Newsfilter· 2024-04-29 11:00
THE WOODLANDS, Texas, April 29, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) will release its first quarter 2024 financial results on Thursday, May 2, 2024 after the markets close. Management will conduct a conference call and live webcast at 5:00 p.m. ET (4:00 p.m. CT) that day to discuss the financial results and to provide a business update. Dial-in InformationU.S. Dial-in Number: (888) 317-6003International Dial-in Number: (412) 317-6061Conference ID: 5993982 Replay InformationU. ...
Lexicon Pharmaceuticals to Host 2024 Investor Day
Newsfilter· 2024-04-18 12:00
THE WOODLANDS, Texas, April 18, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that senior company executives will be joined by leading physicians at the Lexicon 2024 Investor Day on April 22, 2024. The event will be held in New York City from 9:00 a.m. to 12:00 p.m. ET. Business and scientific updates will be presented by Lonnel Coats, Lexicon's chief executive officer; Jeff Wade, Lexicon's president and chief financial officer; Alan Main, Ph.D., Lexicon's executive vi ...
All You Need to Know About Lexicon (LXRX) Rating Upgrade to Buy
Zacks Investment Research· 2024-04-16 17:01
Investors might want to bet on Lexicon Pharmaceuticals (LXRX) , as it has been recently upgraded to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.Individual in ...
Lexicon Pharmaceuticals(LXRX) - 2023 Q4 - Annual Report
2024-03-25 20:00
| 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 | | | | or | | | | ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT | | | | OF 1934 | | | | For the Transition Period from _____________ to _____________ | | | | Commission Fil ...
Lexicon Pharmaceuticals(LXRX) - 2023 Q4 - Annual Results
2024-03-11 11:26
Exhibit 10.1 PREFERRED STOCK PURCHASE AGREEMENT dated as of March 11, 2024 by and among LEXICON PHARMACEUTICALS, INC. and THE PURCHASERS PARTY HERETO RECITALS WHEREAS, each Purchaser, severally and not jointly, proposes to buy from the Company, and the Company proposes to issue and sell to the Purchasers, certain shares of its Series A Convertible Preferred Stock, par value $0.01 per share (the "Preferred Stock"), in reliance on the exemption from registration afforded by the provisions of Section 4(a)(2) o ...
Lexicon Pharmaceuticals(LXRX) - 2023 Q3 - Quarterly Report
2023-11-08 21:16
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 or ☐ 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: 000-30111 Lexicon Pharmaceuticals, Inc. (Exact Name of Registrant as Specified in its Charter) (Sta ...
Lexicon Pharmaceuticals(LXRX) - 2023 Q3 - Earnings Call Transcript
2023-11-08 16:01
Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) Q3 2023 Earnings Conference Call November 8, 2023 8:00 AM ET Company Participants Carrie Siragusa - VP of Marketing Lonnel Coats - CEO Tom Garner - Chief Commercial Officer Craig Granowitz - Chief Medical Officer Jeffrey Wade - President and CFO Conference Call Participants Andrew Tsai - Jefferies Joseph Stringer - Needham & Company Operator Good day and welcome to the Lexicon Pharmaceuticals' Third Quarter 2023 Financial Results Conference Call. Today all partici ...