1. THE WOODLANDS, Texas, April 08, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that Jeffrey L. Wade, Lexicon's executive vice president, corporate and administrative affairs and chief financial officer, will participate in a live fireside chat at the 20th Annual Needham Virtual Healthcare Conference on Thursday, April 15, 2021 at 10:15 a.m. ET.

    A webcast of the event will be available in the "Events" section of the Lexicon website at www.lexpharma.com. An archived version of the webcast will be available on the website for two weeks.

    About Lexicon Pharmaceuticals

    Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients' lives. Through its Genome5000™…

    THE WOODLANDS, Texas, April 08, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that Jeffrey L. Wade, Lexicon's executive vice president, corporate and administrative affairs and chief financial officer, will participate in a live fireside chat at the 20th Annual Needham Virtual Healthcare Conference on Thursday, April 15, 2021 at 10:15 a.m. ET.

    A webcast of the event will be available in the "Events" section of the Lexicon website at www.lexpharma.com. An archived version of the webcast will be available on the website for two weeks.

    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 neuropathic pain, heart failure, 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, long-term outlook on its business and the clinical development and therapeutic and commercial potential of its 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 LX9211, sotagliflozin and its other potential 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 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, 2019, 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.

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Investor Relations

    Lexicon Pharmaceuticals

    (281) 863-3421



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  2. THE WOODLANDS, Texas, March 10, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today reported financial results for the three months and full-year ended December 31, 2020 and provided an update on key milestones.

    "During 2020, we substantially strengthened our balance sheet by eliminating 95% of our debt and returned to our roots by focusing on the advancement of our research and development pipeline," said Lonnel Coats, Lexicon's president and chief executive officer.  "We took key steps to advance our pipeline by initiating two proof-of-concept Phase 2 studies of LX9211 in diabetic peripheral neuropathic pain and post-herpetic neuralgia.  We efficiently closed out the sotagliflozin Phase 3 clinical program and, based…

    THE WOODLANDS, Texas, March 10, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today reported financial results for the three months and full-year ended December 31, 2020 and provided an update on key milestones.

    "During 2020, we substantially strengthened our balance sheet by eliminating 95% of our debt and returned to our roots by focusing on the advancement of our research and development pipeline," said Lonnel Coats, Lexicon's president and chief executive officer.  "We took key steps to advance our pipeline by initiating two proof-of-concept Phase 2 studies of LX9211 in diabetic peripheral neuropathic pain and post-herpetic neuralgia.  We efficiently closed out the sotagliflozin Phase 3 clinical program and, based on positive data from two of those Phase 3 studies, SCORED and SOLOIST, we believe that sotagliflozin has the potential to become an important new treatment option for heart failure patients with type 2 diabetes. We will be working expeditiously to file an NDA for sotagliflozin in heart failure in the second half of this year.  With minimal debt and cash sufficient to fund our planned operations for two years, we entered 2021 in a solid financial position to execute on these objectives."

    Fourth Quarter Highlights

    LX9211

    • Patient enrollment continued in RELIEF-DPN-1, a Phase 2 clinical study of LX9211 for the treatment of diabetic peripheral neuropathic pain. Enrollment is expected to total approximately 300 patients at approximately 30 clinical sites.
    • Patient enrollment commenced in RELIEF-PHN 1, a Phase 2 clinical study of LX9211 for the treatment of post-herpetic neuralgia. Enrollment is expected to total approximately 74 patients at approximately 30 clinical sites.
    • Lexicon received Fast Track designation from the FDA for the development of LX9211 in diabetic peripheral neuropathic pain.

    Sotagliflozin

    • SOLOIST and SCORED Phase 3 studies achieved their primary endpoints by demonstrating statistically significant reductions in total cardiovascular deaths, hospitalizations for heart failure and urgent heart failure visits in patients treated with sotagliflozin as compared with placebo.  
    • Data from both studies were presented at the Late-Breaking Science Session of the American Heart Association Scientific Sessions 2020 and simultaneously published in two separate articles in The New England Journal of Medicine.

    Corporate Activities

    • Lexicon raised $70 million in net proceeds from common stock sales.

    2021 Anticipated Milestones and Events

    • NDA filing for sotagliflozin in heart failure.
    • Active efforts to secure strategic alliance for sotagliflozin in heart failure.
    • Phase 2 study results from RELIEF-DPN-1 for LX9211 in diabetic peripheral neuropathic pain.
    • Phase 2 study results from RELIEF-PHN-1 for LX9211 in post-herpetic neuralgia.
    • Additional publications for sotagliflozin and LX9211.

    Fourth Quarter and Full-Year 2020 Financial Highlights

    Unless otherwise stated, all comparisons are for the fourth quarter and full year of 2020 compared to the fourth quarter and full year of 2019.

    Revenues: Revenues for the fourth quarter of 2020 decreased to $0.2 million from $8.7 million for the corresponding period in 2019, primarily due to the elimination of product revenues as a result of the sale of XERMELO during the third quarter of 2020. Full-year 2020 revenues decreased to $24.0 million from $322.1 million in 2019. Full-year 2019 revenues included collaborative revenues of $289.2 million, primarily from the termination of the alliance with Sanofi and recognition of the remaining amounts for performance obligations from the initial agreement with Sanofi.

    Research and Development (R&D) Expenses: Due to a reduction in external clinical development cost estimates primarily related to sotagliflozin, research and development expenses for the fourth quarter of 2020 decreased to $1.0 million from $40.6 million for the corresponding period in 2019. Full-year R&D expenses for 2020 increased to $153.6 million from $91.9 million in 2019, primarily due to increases in external clinical development costs related to sotagliflozin subsequent to the termination of the alliance with Sanofi in September 2019.

    Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the fourth quarter of 2020 decreased to $6.4 million from $14.6 million for the corresponding period in 2019, primarily due to lower salaries and benefits as a result of reductions in personnel and elimination of marketing expenses following the sale of XERMELO in the third quarter of 2020. Full-year SG&A expenses for 2020 decreased to $47.2 million from $56.8 million, primarily due to lower salaries and benefits and marketing costs.

    Gain on Sale of XERMELO: A gain of $132.6 million was recognized during 2020 from the sale of XERMELO and related assets to TerSera Therapeutics LLC in September 2020.

    Net Income (Loss): Net loss for the fourth quarter of 2020 was $5.5 million, or $0.04 per share, as compared to a net loss of $51.1 million, or $0.48 per share, in the corresponding period in 2019. For the three months ended December 31, 2020 and 2019, net loss included non-cash, stock-based compensation expense of $2.7 million and $3.5 million, respectively. Net loss for the year ended December 31, 2020 was $58.6 million, or $0.53 per share, as compared to a net income of $130.1 million, or $1.16 per diluted share, in 2019. For the years ended December 31, 2020 and 2019, net loss included non-cash, stock-based compensation expense of $13.3 million and $14.2 million, respectively.

    Cash and Investments: As of December 31, 2020, Lexicon had $152.3 million in cash and investments, as compared to $271.7 million as of December 31, 2019.

    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 888-645-5785 (U.S./Canada) or 970-300-1531 (international). The conference ID for all callers is 3793713. The live webcast and replay may be accessed by visiting Lexicon's website at www.lexpharma.com/investors. 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 neuropathic pain, heart failure, 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 LX9211, sotagliflozin 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 LX9211, sotagliflozin and its other potential 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 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, 2019, 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 December 31, Year Ended December 31,  
    (In thousands, except per share data) 2020 2019 2020 2019  
      (Unaudited)   (Unaudited)    
    Revenues:          
    Net product revenue $-  $8,568  $23,404  $32,331   
    Collaborative agreements  -   22   33   289,231   
    Royalties and other revenue  199   137   558   511   
    Total revenues  199   8,727   23,995   322,073   
    Operating expenses:          
    Cost of sales (including finite-lived intangible          
         asset amortization)  -   774   1,929   3,231   
    Research and development, including stock-based          
         compensation of $1,223, $1,727, $6,376 and $7,096, respectively  992   40,606   153,621   91,924   
    Selling, general and administrative, including stock-based          
         compensation of $1,457, $1,752, $6,898 and $7,122, respectively  6,432   14,564   47,230   56,835   
    Impairment loss on buildings  -   -   1,600   -   
    Impairment loss on intangible asset  -   -   -   28,638   
    Total operating expenses  7,424   55,944   204,380   180,628   
    Other operating income:          
    Gain (loss) on sale of XERMELO  (233)  -   132,585   -   
    Income (loss) from operations  (7,458)  (47,217)  (47,800)  141,445   
    Gain on debt extinguishments, net  1,258   -   1,003   -   
    Interest expense  (170)  (5,191)  (14,544)  (20,676)  
    Interest and other income, net  875   1,270   2,767   3,350   
    Net income (loss) before income taxes  (5,495)  (51,138)  (58,574)  124,119   
    Income tax benefit  -   -   -   6,014   
    Net income (loss) $(5,495) $(51,138) $(58,574) $130,133   
               
    Net income (loss) per common share, basic $(0.04) $(0.48) $(0.53) $1.23   
    Net income (loss) per common share, diluted $(0.04) $(0.48) $(0.53) $1.16   
               
               
    Shares used in computing net income (loss) per common share, basic  122,359   106,272   110,841   106,218   
    Shares used in computing net income (loss) per common share, diluted  122,359   106,272   110,841   116,747   
               
               
          As of As of  
    Consolidated Balance Sheet Data     December 31, 2020 December 31, 2019 
    (In thousands)     (Unaudited)    
       Cash and investments   $152,275  $271,659   
       Property and equipment, net    295   14,047   
       Goodwill    44,543   44,543   
       Other intangible assets    -   19,716   
       Total assets    203,788   417,715   
       Current and long-term debt    11,646   245,183   
       Accumulated deficit    (1,400,018)  (1,341,444)  
       Total stockholders' equity    156,371   117,101   

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Investor Relations

    Lexicon Pharmaceuticals

    (281) 863-3421

     



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  3. THE WOODLANDS, Texas, March 04, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), will release its fourth quarter and full-year 2020 financial results on Wednesday, March 10, 2021 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 Information
    U.S. Dial-in Number: (888) 645-5785
    International Dial-in Number:   (970) 300-1531
    Conference ID: 3793713

    Replay Information
    U.S. Dial-in Number: (855) 859-2056
    Replay International Dial-in Number: (404) 537-3406
    Conference ID: 3793713

    The dial-in replay will be available for 14 days following the call. An audio webcast will be available…

    THE WOODLANDS, Texas, March 04, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), will release its fourth quarter and full-year 2020 financial results on Wednesday, March 10, 2021 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 Information

    U.S. Dial-in Number: (888) 645-5785

    International Dial-in Number:   (970) 300-1531

    Conference ID: 3793713

    Replay Information

    U.S. Dial-in Number: (855) 859-2056

    Replay International Dial-in Number: (404) 537-3406

    Conference ID: 3793713

    The dial-in replay will be available for 14 days following the call. An audio webcast will be available online at www.lexpharma.com/events, with a webcast replay accessible for 14 days after the call.

    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 neuropathic pain, heart failure, 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, long-term outlook on its business and the clinical development and therapeutic and commercial potential of its 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 LX9211, sotagliflozin and its other potential 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 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, 2019, 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.

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Investor Relations

    Lexicon Pharmaceuticals

    (281) 863-3421



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  4. THE WOODLANDS, Texas, Jan. 14, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) announced today that it has received U.S. Food and Drug Administration (FDA) regulatory feedback that the results of its SOLOIST and SCORED Phase 3 clinical studies can support a new drug application (NDA) submission for an indication to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in adult patients with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure.

    The feedback was provided in response to a request made by Lexicon following the completion of the SOLOIST and SCORED studies relating to the potential submission of an NDA based…

    THE WOODLANDS, Texas, Jan. 14, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) announced today that it has received U.S. Food and Drug Administration (FDA) regulatory feedback that the results of its SOLOIST and SCORED Phase 3 clinical studies can support a new drug application (NDA) submission for an indication to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent visits for heart failure in adult patients with type 2 diabetes with either worsening heart failure or additional risk factors for heart failure.

    The feedback was provided in response to a request made by Lexicon following the completion of the SOLOIST and SCORED studies relating to the potential submission of an NDA based on the results of such studies, taking into account their early close-out and other considerations. This regulatory feedback clears a key hurdle for partnership discussions around sotagliflozin in heart failure and enables a potential NDA filing in 2021.

    Lonnel Coats, Lexicon's president and chief executive officer, will present at the 39th Annual J.P. Morgan Healthcare Conference today at 2:50 p.m. ET. A webcast of the event will be available in the "Events" section of the Lexicon website at www.lexpharma.com.

    About the SOLOIST and SCORED Studies

    SOLOIST was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 1,222 patients with type 2 diabetes who had recently been hospitalized for worsening heart failure. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo.

    SCORED was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 10,584 patients with type 2 diabetes, chronic kidney disease with eGFR of 25 to 60 ml per minute per 1.73 m2 of body-surface area, and risks for cardiovascular disease. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo.

    Both SOLOIST and SCORED achieved their respective primary endpoints. Results from both studies were presented at the Late-Breaking Science Session of the American Heart Association (AHA) Scientific Sessions 2020 and simultaneously published in The New England Journal of Medicine (NEJM) in two separate articles titled: "Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure" and "Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease."

    About Sotagliflozin

    Discovered using Lexicon's unique approach to gene science, sotagliflozin is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Sotagliflozin is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy, but has not yet been commercially launched.

    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 neuropathic pain, heart failure, 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 clinical development of and regulatory filings for sotagliflozin, partnership discussions relating to sotagliflozin and the potential therapeutic and commercial potential of sotagliflozin, as well as 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 its other 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 LX9211, sotagliflozin and its other potential 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 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, 2019, 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.

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Investor Relations

    Lexicon Pharmaceuticals

    (281) 863-3421



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  5. THE WOODLANDS, Texas, Jan. 06, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that Lonnel Coats, Lexicon's president and chief executive officer, will present at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14, 2021 at 2:50 p.m. ET. 

    A webcast of the event will be available in the "Events" section of the Lexicon website at www.lexpharma.com.  An archived version of the webcast will be available on the website for two weeks.

    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…

    THE WOODLANDS, Texas, Jan. 06, 2021 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that Lonnel Coats, Lexicon's president and chief executive officer, will present at the 39th Annual J.P. Morgan Healthcare Conference on Thursday, January 14, 2021 at 2:50 p.m. ET. 

    A webcast of the event will be available in the "Events" section of the Lexicon website at www.lexpharma.com.  An archived version of the webcast will be available on the website for two weeks.

    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 neuropathic pain, heart failure, 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, long-term outlook on its business and the clinical development and therapeutic and commercial potential of its 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 LX9211, sotagliflozin and its other potential 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 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, 2019, 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.

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Investor Relations

    Lexicon Pharmaceuticals

    (281) 863-3421



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  6. THE WOODLANDS, Texas, Dec. 31, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today the commencement of patient dosing in RELIEF-PHN 1, a Phase 2 randomized, placebo-controlled, multi-center clinical study of LX9211 for the treatment of post-herpetic neuralgia. LX9211 is a potent oral small molecule inhibitor of adaptor associated kinase 1 (AAK1).

    "We are pleased to commence dosing in our second proof-of-concept study of LX9211," said Praveen Tyle, Ph.D., executive vice president of research and development. "People who develop shingles often suffer with persistent pain for months to years after the rash clears with limited treatment options. We believe LX9211 has the potential to offer a novel therapeutic…

    THE WOODLANDS, Texas, Dec. 31, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today the commencement of patient dosing in RELIEF-PHN 1, a Phase 2 randomized, placebo-controlled, multi-center clinical study of LX9211 for the treatment of post-herpetic neuralgia. LX9211 is a potent oral small molecule inhibitor of adaptor associated kinase 1 (AAK1).

    "We are pleased to commence dosing in our second proof-of-concept study of LX9211," said Praveen Tyle, Ph.D., executive vice president of research and development. "People who develop shingles often suffer with persistent pain for months to years after the rash clears with limited treatment options. We believe LX9211 has the potential to offer a novel therapeutic approach to treating post-herpetic neuralgia. We look forward to completing this study and our other proof-of-concept study of LX9211 in diabetic peripheral neuropathic pain toward the end of next year."

    About the RELIEF-PHN 1 Study

    RELIEF-PHN 1 is a Phase 2 randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy, safety and pharmacokinetics of LX9211 in the treatment of post-herpetic neuralgia. The study is designed to enroll approximately 74 patients at approximately 30 clinical sites. The primary efficacy endpoint under evaluation is the change from baseline (Day 1) to Week 6 in Average Daily Pain Score (ADPS), based on the 11-point numerical rating scale (NRS).

    About LX9211

    LX9211 is a potent, orally delivered, selective small molecule inhibitor of AAK1. Lexicon identified AAK1 in its target discovery efforts as a promising approach for the treatment of neuropathic pain, and identified LX9211 and another development candidate in a neuroscience drug discovery alliance with Bristol-Myers Squibb from which Lexicon holds exclusive development and commercialization rights. Preclinical studies of LX9211 demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways. LX9211 has received Fast Track designation from the U.S. Food and Drug Administration for the development in diabetic peripheral neuropathic pain.

    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 neuropathic pain, heart failure, 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, long-term outlook on its business and the clinical development and therapeutic and commercial potential of its 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 LX9211, sotagliflozin and its other potential 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 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, 2019, 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.

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Investor Relations

    Lexicon Pharmaceuticals

    (281) 863-3421



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  7. THE WOODLANDS, Texas, Dec. 16, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today that it has entered a collaboration enabling the use by AC Bioscience LTD of preclinical and clinical data for LX2931 without granting any right or license under any of Lexicon's patent rights for the compound. LX2931 is a small molecule sphingosine-1-phosphate (S1P) lyase inhibitor that is currently not in active development at Lexicon.

    "In line with our realignment around the rapid development of the LX9211 program, we continue to evaluate our pipeline and determine the most effective way to advance our broad library of compounds and targets," said Praveen Tyle, Ph.D., executive vice president of research and development…

    THE WOODLANDS, Texas, Dec. 16, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today that it has entered a collaboration enabling the use by AC Bioscience LTD of preclinical and clinical data for LX2931 without granting any right or license under any of Lexicon's patent rights for the compound. LX2931 is a small molecule sphingosine-1-phosphate (S1P) lyase inhibitor that is currently not in active development at Lexicon.

    "In line with our realignment around the rapid development of the LX9211 program, we continue to evaluate our pipeline and determine the most effective way to advance our broad library of compounds and targets," said Praveen Tyle, Ph.D., executive vice president of research and development. "We are pleased to collaborate with AC Bioscience to accelerate their efforts around S1P and look forward to learning additional information about this potentially interesting pathway."

    Under the terms of the agreement, Lexicon will receive an upfront payment and is eligible to receive milestone payments totaling up to $5.3 million in the aggregate.

    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 neuropathic pain, heart failure, 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, long-term outlook on its business and the clinical development and therapeutic and commercial potential of its 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 LX9211, sotagliflozin and its other potential 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 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, 2019, 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.

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Investor Relations

    Lexicon Pharmaceuticals

    (281) 863-3421



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  8. THE WOODLANDS, Texas, Dec. 11, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that it had entered into a securities purchase agreement with certain institutional investors providing for the purchase and sale, in a registered direct offering, of 20,312,500 shares of its common stock, par value $0.001 (the "Common Stock"), at a price of $3.20 per share, for aggregate gross proceeds to the Company of $65,000,000 before deducting fees to the placement agent and other estimated offering expenses payable by the Company. The transaction is expected to close on December 16, 2020, subject to satisfaction of customary closing conditions.

    The investors in the registered direct offering were Artal International S.C.A…

    THE WOODLANDS, Texas, Dec. 11, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that it had entered into a securities purchase agreement with certain institutional investors providing for the purchase and sale, in a registered direct offering, of 20,312,500 shares of its common stock, par value $0.001 (the "Common Stock"), at a price of $3.20 per share, for aggregate gross proceeds to the Company of $65,000,000 before deducting fees to the placement agent and other estimated offering expenses payable by the Company. The transaction is expected to close on December 16, 2020, subject to satisfaction of customary closing conditions.

    The investors in the registered direct offering were Artal International S.C.A., an affiliate of Invus, L.P., and BVF Partners L.P. and certain affiliates of BVF Partners L.P.

    Citigroup Global Markets Inc. is acting as placement agent for the offering on a "reasonable best efforts" basis.

    The Common Stock described above is being offered by the Company pursuant to a "shelf" registration statement on Form S-3, which was originally filed with the Securities and Exchange Commission (the "SEC") on November 7, 2019, and was declared effective on November 18, 2019 (File No. 333-234568). A prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available for free on the SEC's website at http://www.sec.gov or may be obtained from: Citigroup Global Markets Inc., c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at 1-800-831-9146.

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

    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 neuropathic pain, heart failure, diabetes and metabolism and other indications.

    Safe Harbor Statement

    This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All forward-looking statements, including, without limitation, statements about the completion and timing of the offering, are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, including Lexicon's ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of LX9211, sotagliflozin and its other potential 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 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 filings with the Securities and Exchange Commission, including its annual report on Form 10-K for the year ended December 31, 2019 and under the heading "Risk Factors" in the final prospectus supplement related to the proposed public offering of common stock to be 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.

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Investor Relations

    Lexicon Pharmaceuticals

    (281) 863-3421



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  9. THE WOODLANDS, Texas, Dec. 11, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the development of LX9211 in diabetic peripheral neuropathic pain.

    "The FDA's Fast Track designation of LX9211 reflects the serious unmet medical need of people suffering from diabetic peripheral neuropathic pain," said Praveen Tyle, Ph.D., executive vice president of research and development. "We look forward to working closely with the FDA throughout the clinical development process to bring this potential new innovative treatment to patients as quickly as possible."

    Lexicon is currently enrolling patients with diabetic…

    THE WOODLANDS, Texas, Dec. 11, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for the development of LX9211 in diabetic peripheral neuropathic pain.

    "The FDA's Fast Track designation of LX9211 reflects the serious unmet medical need of people suffering from diabetic peripheral neuropathic pain," said Praveen Tyle, Ph.D., executive vice president of research and development. "We look forward to working closely with the FDA throughout the clinical development process to bring this potential new innovative treatment to patients as quickly as possible."

    Lexicon is currently enrolling patients with diabetic peripheral neuropathic pain in a Phase 2 proof-of-concept study of LX9211 and is preparing to initiate a second Phase 2 clinical trial of LX9211 in post-herpetic neuralgia.

    The FDA's Fast Track designation is designed to facilitate the development and expedite the review of drugs that are being developed to treat serious conditions and fill unmet medical needs. The purpose of the designation is to expedite the timeline for bringing important new drugs to patients. Programs receiving Fast Track designation may benefit from early and frequent interactions with the FDA over the course of drug development. In addition, the Fast Track designation program provides eligibility for accelerated approval and priority review if relevant criteria are met and enables sponsors to submit individual sections of a New Drug Application (NDA) for review on a rolling-submission basis.

    About LX9211

    LX9211 is a potent, orally delivered, selective small molecule inhibitor of adapter-associated kinase 1 (AAK1). Lexicon identified AAK1 in its target discovery efforts as a promising approach for the treatment of neuropathic pain, and identified LX9211 and another development candidate in a neuroscience drug discovery alliance with Bristol-Myers Squibb from which Lexicon holds exclusive development and commercialization rights. Preclinical studies of LX9211 demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways.

    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 neuropathic pain, heart failure, 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, long-term outlook on its business and the clinical development and therapeutic and commercial potential of its 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 LX9211, sotagliflozin and its other potential 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 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, 2019, 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.

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Investor Relations

    Lexicon Pharmaceuticals

    (281) 863-3421



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  10. THE WOODLANDS, Texas, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today announced that both the SOLOIST and SCORED Phase 3 studies achieved their primary endpoints by demonstrating statistically significant reductions in total cardiovascular deaths, hospitalizations for heart failure and urgent heart failure visits in patients treated with sotagliflozin as compared with placebo.

    THE WOODLANDS, Texas, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today announced that both the SOLOIST and SCORED Phase 3 studies achieved their primary endpoints by demonstrating statistically significant reductions in total cardiovascular deaths, hospitalizations for heart failure and urgent heart failure visits in patients treated with sotagliflozin as compared with placebo.

    In the SOLOIST study, the primary endpoint was achieved with a hazard ratio (HR) of 0.67 (p<0.001) in people with type 2 diabetes and a recent hospitalization for worsening heart failure. In the SCORED study, the primary endpoint was achieved with a hazard ratio of 0.74 (p<0.001) in people with type 2 diabetes and chronic kidney disease with an estimated glomerular filtration rate (eGFR) of 25 to 60 ml/minute per 1.73 m² of body-surface area.

    The key results from SOLOIST and SCORED were presented today at the Late-Breaking Science Session of the American Heart Association (AHA) Scientific Sessions 2020 and simultaneously published in The New England Journal of Medicine (NEJM) in two separate articles titled: "Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure" and "Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease." The articles may be accessed at www.nejm.org.

    "Cardiovascular disease continues to be a leading cause of death in people with type 2 diabetes," said Deepak L. Bhatt, M.D., M.P.H., executive director of Interventional Cardiovascular Programs at Brigham and Women's Hospital and a professor of medicine at Harvard Medical School and study chair and lead author for the NEJM publications of the SOLOIST and SCORED results. "SOLOIST demonstrates that early, in-hospital initiation of sotagliflozin in patients with worsening heart failure significantly reduces subsequent cardiovascular events, an effect that was consistent across groups with heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF). SCORED demonstrates that sotagliflozin significantly reduces heart failure events in a patient population with stage 3 and 4 chronic kidney disease and cardiovascular risk. Both studies add to the evidence that SGLT2 inhibition should be standard of care in heart failure, and the SCORED data reflecting a reduction in myocardial infarction and stroke and better glucose control in CKD patients suggest potential benefits from the dual SGLT1 and SGLT2 mechanism of this particular agent."

    Key SOLOIST Phase 3 Study Results

    SOLOIST was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 1,222 patients with type 2 diabetes who had recently been hospitalized for worsening heart failure. The primary endpoint was the total number of events comprised of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients starting treatment with 200 mg sotagliflozin once daily compared with placebo, with dosing initiated either before or within 3 days of hospital discharge.

    The first dose of sotagliflozin or placebo was administered prior to hospital discharge in 48.8% of the patients and a median of two days after discharge in 51.2% of the patients, with the benefits of sotagliflozin being consistent between those prespecified subgroups of patients. The initial 200 mg once daily dose of sotagliflozin was increased to 400 mg once daily if unacceptable side effects did not occur.

    Treatment with sotagliflozin resulted in a significantly lower total number of cardiovascular deaths, heart failure hospitalizations and urgent visits as compared to placebo. A total of 600 primary endpoint events occurred in the study, with 245 events in the sotagliflozin treated group and 355 events in the placebo group. There were 51.0 primary endpoint events per 100 patient-years in the sotagliflozin treated group as compared to 76.3 events per 100 patient-years in the placebo group (HR=0.67; 95% confidence interval [CI]=0.52 to 0.85; p<0.001). There were 10.6 events of cardiovascular death per 100 patient-years in the sotagliflozin treated group as compared to 12.5 events per 100 patient-years in the placebo group (HR=0.84; 95% CI=0.58 to 1.22; p=0.36).

    Of note, effects on the primary endpoint were consistent among patients suffering from heart failure with reduced ejection fraction (HFrEF) and heart failure with preserved ejection fraction (HFpEF), with a hazard ratio of 0.72 (95% CI=0.56 to 0.94) in patients with a left ventricular ejection fraction (LVEF) of less than 50% and a hazard ratio of 0.48 (95% CI=0.27 to 0.86) in patients with a LVEF of greater than or equal to 50%.

    Serious adverse events that led to discontinuation of study drug, as determined by investigators, occurred in 3.0% (n=18) of the patients in the sotagliflozin treated group and in 2.8% (n=17) of the patients in the placebo group. Based on investigator reported events, the most common adverse events of special interest included hypotension (6.0% on sotagliflozin versus 4.6% on placebo), urinary tract infections (4.8% on sotagliflozin versus 5.1% on placebo), acute kidney injury (4.1% on sotagliflozin versus 4.4% on placebo), and diarrhea (6.1% on sotagliflozin versus 3.4% on placebo). Among other adverse events of interest, in SOLOIST, genital mycotic infections (0.8% on sotagliflozin vs. 0.2% on placebo) were infrequent, severe hypoglycemia (1.5% on sotagliflozin vs. 0.3% on placebo) was more common in the sotagliflozin treated group and diabetic ketoacidosis (0.3% on sotagliflozin vs. 0.7% on placebo) was similar between treatment groups.

    The SOLOIST study was originally designed with a primary endpoint of the first occurrence of death from cardiovascular causes or hospitalization for heart failure, as determined by independent adjudication, but was modified in connection with the early close out of the study to include urgent heart failure visits and reflect the total number of events, as determined by investigators, in order to enhance the statistical power of the comparison. The specification of the primary endpoint based on total events was implemented without any awareness of the study outcomes or study-group assignments and without information from an interim analysis.

    The results for first occurrence of cardiovascular death or hospitalization for heart failure (HR=0.71; 95% CI=0.57 to 0.89; p=0.003) based on investigator reported events were consistent with those of the modified primary endpoint.

    Key SCORED Phase 3 Study Results

    SCORED was a multi-center, randomized, double-blinded, placebo-controlled Phase 3 study evaluating the cardiovascular efficacy of sotagliflozin versus placebo when added to standard of care in 10,584 patients with type 2 diabetes, chronic kidney disease with eGFR of 25 to 60 ml per minute per 1.73 m² of body-surface area, and risks for cardiovascular disease. The primary endpoint was the total number of deaths from cardiovascular causes, hospitalizations for heart failure, and urgent visits for heart failure in patients treated with sotagliflozin compared with placebo. The initial 200 mg once daily dose of sotagliflozin was increased to 400 mg once daily if unacceptable side effects did not occur.

    Treatment with sotagliflozin resulted in a significantly lower total number of cardiovascular deaths, heart failure hospitalizations and urgent visits as compared to placebo. A total of 930 primary endpoint events occurred in the study, with 400 events in the sotagliflozin treated group and 530 events in the placebo group. There were 5.6 primary endpoint events per 100 patient-years in the sotagliflozin treated group as compared to 7.5 events per 100 patient-years in the placebo group (HR=0.74; 95% CI=0.63 to 0.88; p<0.001). There were 2.2 events of cardiovascular death per 100 patient-years in the sotagliflozin treated group as compared to 2.4 events per 100 patient-years in the placebo group (HR=0.90; 95% CI=0.73 to 1.12; p=0.35).

    Of note, over the course of the study, the data showed an average reduction in hemoglobin A1c of 0.56% in the sotagliflozin treated group as compared to a reduction of 0.25% in the placebo group in patients with severe chronic kidney disease, eGFR less than 30 ml per minute per 1.73 m² of body-surface area (p<0.001). In patients with moderate chronic kidney disease, eGFR greater than or equal to 30 ml per minute per 1.73 m² of body-surface area, the data showed an average reduction in hemoglobin A1c of 0.60% in the sotagliflozin treated group as compared to a reduction of 0.17% in the placebo group (p<0.001).

    Serious adverse events that led to discontinuation of study drug, as determined by investigators, occurred in 2.1% (n=112) of the patients in the sotagliflozin treated group and in 1.8% (n=94) of the patients in the placebo group. Based on investigator reported events, the most common adverse events of special interest included urinary tract infections (11.5% on sotagliflozin versus 11.1% on placebo), diarrhea (8.5% on sotagliflozin versus 6.0% on placebo), volume depletion (5.3% on sotagliflozin versus 4.0% on placebo), bone fractures (2.1% on sotagliflozin versus 2.2% on placebo), and genital mycotic infections (2.4% on sotagliflozin versus 0.9% on placebo). Among other adverse events of interest, diabetic ketoacidosis (0.6% on sotagliflozin vs. 0.3% on placebo) was more common in the sotagliflozin treated group and severe hypoglycemia (1.0% on sotagliflozin vs. 1.0% on placebo) was similar between treatment groups.

    The SCORED study was originally designed with co-primary endpoints, assessed in time-to-event analyses, of the first occurrence of a major adverse cardiovascular event (defined as death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke, or 3-point MACE) and the first occurrence of death from cardiovascular causes or hospitalization for heart failure, as determined by independent adjudication, but were modified in connection with the early close out of the study to include urgent heart failure visits and reflect the total number of events, as determined by investigators, in order to enhance the statistical power of the comparison. The specification of the primary endpoint based on total events was implemented without any awareness of the study outcomes or study-group assignments and without information from an interim analysis.

    In a time-to-event analysis, applying the original co-primary endpoints based on investigator reported events, the results for both the first occurrence of a MACE event (HR=0.84; 95% CI=0.72 to 0.99; p=0.035) and the first occurrence of death from cardiovascular causes or hospitalization for heart failure (HR=0.78; 95% CI=0.66 to 0.91; p=0.001) were consistent with those of the modified primary endpoint.

    About Sotagliflozin

    Discovered using Lexicon's unique approach to gene science, sotagliflozin is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Sotagliflozin is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m², who could not achieve adequate glycemic control despite optimal insulin therapy, but has not yet been commercially launched.

    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 diabetes and metabolism, neuropathic pain 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 clinical development of sotagliflozin and the clinical development and therapeutic and commercial potential of sotagliflozin. In addition, this press release also contains forward looking statements relating to Lexicon's financial position, long term outlook on its business, 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 the risk that the FDA and other regulatory authorities may not grant regulatory approval of sotagliflozin, and the risk that such regulatory approvals, if granted, may have significant limitations on the approved use of sotagliflozin. As a result, sotagliflozin may never be successfully commercialized. Other risks include Lexicon's ability to meet its capital requirements, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of LX9211 and its other potential 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 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, 2019, 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.

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Investor Relations

    Lexicon Pharmaceuticals

    (281) 863-3421



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  11. THE WOODLANDS, Texas, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced its participation in the following conference:

    • Stifel 2020 Virtual Healthcare Conference on Wednesday, November 18, 2020

    Lonnel Coats, Lexicon's president and chief executive officer, and Jeffrey L. Wade, Lexicon's executive vice president, corporate and administrative affairs and chief financial officer, will participate in a live fireside chat on Wednesday, November 18, 2020 at 2:40 p.m. ET. A webcast of the event will be available in the "Events" section of the Lexicon website at www.lexpharma.com. An archived version of the webcast will be available on the website for two weeks.

    About Lexicon Pharmaceuticals

    Lexicon is…

    THE WOODLANDS, Texas, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced its participation in the following conference:

    • Stifel 2020 Virtual Healthcare Conference on Wednesday, November 18, 2020

    Lonnel Coats, Lexicon's president and chief executive officer, and Jeffrey L. Wade, Lexicon's executive vice president, corporate and administrative affairs and chief financial officer, will participate in a live fireside chat on Wednesday, November 18, 2020 at 2:40 p.m. ET. A webcast of the event will be available in the "Events" section of the Lexicon website at www.lexpharma.com. An archived version of the webcast will be available on the website for two weeks.

    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 diabetes and metabolism, neuropathic pain 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, long-term outlook on its business and the clinical development and therapeutic and commercial potential of its 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 LX9211, sotagliflozin and its other potential 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 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, 2019, 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.

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Investor Relations

    Lexicon Pharmaceuticals

    (281) 863-3421

     



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  12. THE WOODLANDS, Texas, Oct. 29, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today reported financial results for the three months ended September 30, 2020 and provided an update of key milestones.

    "In the third quarter, we streamlined our operations to prioritize our focus on our advancement of LX9211, a promising drug candidate with potential to become a treatment option for the millions of people living with neuropathic pain. Most people suffering with neuropathic pain experience only limited success with available therapies while enduring substantial side effects," said Lonnel Coats, Lexicon's president and chief executive officer. "We have commenced our first Phase 2 study in diabetic peripheral neuropathic…

    THE WOODLANDS, Texas, Oct. 29, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today reported financial results for the three months ended September 30, 2020 and provided an update of key milestones.

    "In the third quarter, we streamlined our operations to prioritize our focus on our advancement of LX9211, a promising drug candidate with potential to become a treatment option for the millions of people living with neuropathic pain. Most people suffering with neuropathic pain experience only limited success with available therapies while enduring substantial side effects," said Lonnel Coats, Lexicon's president and chief executive officer. "We have commenced our first Phase 2 study in diabetic peripheral neuropathic pain and plan to commence our second Phase 2 study in post-herpetic neuralgia shortly with results for both studies expected by the end of next year."

    Third Quarter Highlights

    LX9211

    • Commenced patient dosing in RELIEF-DPN-1, a Phase 2 randomized, placebo-controlled, multi-center clinical study of LX9211 for the treatment of diabetic peripheral neuropathic pain. Enrollment is expected to total approximately 300 patients at 30 U.S. clinical sites.
    • Preparing to commence an additional Phase 2 study of LX9211 in post-herpetic neuralgia later this year.

    Realignment and Debt Reduction

    • Realignment of the business around LX9211, sotagliflozin and other drug discovery and development programs.
    • Reduced outstanding debt by more than 90%, including the elimination of its $150 million secured term loan and $75.8 million principal amount of its 5.25% Convertible Senior Notes due 2021.

    XERMELO® (telotristat ethyl)

    • XERMELO U.S. net sales were $6.5 million in the third quarter of 2020, reflecting sales during the quarter prior to the completion of the sale of XERMELO and related assets to TerSera Therapeutics LLC on September 8, 2020.
    • Received $160.4 million in cash at closing of the sale and eligible to receive up to $65 million in additional milestone payments for the development and commercialization of XERMELO in patients with biliary tract cancer and mid-teens royalties on net sales of XERMELO in biliary tract cancer.

    Sotagliflozin

    • Announced topline data from four Phase 3 sotagliflozin studies in type 2 diabetes: SOTA-MONO, SOTA-SU, SOTA-GLIM and SOTA-INS with all four studies meeting their primary objectives of lowering A1C in patients with type 2 diabetes.

    Upcoming Milestones

    • Q4 2020: Initiation of a Phase 2 study for LX9211 in post-herpetic neuralgia.
    • Q4 2020: Presentation of data from the sotagliflozin SOLOIST and SCORED Phase 3 studies at the American Heart Association Scientific Sessions 2020.
    • Q4 2021: Phase 2 study results in diabetic peripheral neuropathic pain and in post-herpetic neuralgia.

    Third Quarter 2020 Financial Highlights

    Revenues: Revenues for the three months ended September 30, 2020 decreased to $6.6 million from $294.4 million for the corresponding period in 2019. The three months ended September 30, 2019 included collaborative revenues of $260.0 million from the termination of the alliance with Sanofi and recognition of the remaining amount of $23.5 million allocated to performance obligations from the initial agreement with Sanofi. Net product revenues for the three months ended September 30, 2020 consisted of $6.5 million from net sales of XERMELO in the U.S.

    Cost of Sales: Cost of sales related to sales of XERMELO for the three months ended September 30, 2020 and 2019 were $0.6 million.

    Research and Development (R&D) Expenses: Research and development expenses for the three months ended September 30, 2020 increased to $40.1 million from $26.7 million for the corresponding period in 2019, primarily due to increases in external clinical development costs related to sotagliflozin subsequent to the termination of the alliance with Sanofi.

    Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the three months ended September 30, 2020 decreased to $12.0 million from $13.9 million for the corresponding period in 2019.

    Gain on Sale of XERMELO: A gain of $132.8 million was recognized for the three months ended September 30, 2020 from the sale of XERMELO and related assets to TerSera.

    Net Income: Net income for the three months ended September 30, 2020 was $82.6 million, or $0.71 per diluted share, as compared to net income of $226.1 million, or $1.95 per diluted share, in the corresponding period in 2019. For the three months ended September 30, 2020 and 2019, net loss included non-cash, stock-based compensation expense of $1.9 million and $3.6 million, respectively.

    Cash and Investments: As of September 30, 2020, Lexicon had $111.4 million in cash and investments, as compared to $271.7 million as of December 31, 2019.

    Conference Call and Webcast Information

    Lexicon management will hold a live conference call and webcast today at 8:00 am ET / 7:00 am 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) 645-5785 (U.S./Canada) or (970) 300-1531 (international). The conference ID for all callers is 7787988. The live webcast and replay may be accessed by visiting Lexicon's website at http://www.lexpharma.com/events. An archived version of the webcast will be available on the website for 14 days.

    About LX9211

    LX9211 is a potent, orally delivered, selective small molecule inhibitor of AAK1, a target with a pain phenotype discovered and extensively characterized in an alliance with Bristol Myers Squibb. Preclinical studies of LX9211 demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways. Lexicon holds exclusive research, development and commercialization rights to LX9211 and additional compounds acting through AAK1 under the alliance.

    About Sotagliflozin

    Discovered using Lexicon's unique approach to gene science, sotagliflozin is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Sotagliflozin is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy, but has not yet been commercially launched.

    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 diabetes and metabolism, neuropathic pain 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, long-term outlook on its business and the clinical development and therapeutic and commercial potential of its 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 LX9211, sotagliflozin and its other potential 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 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, 2019, 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) 2020 2019 2020 2019
      (Unaudited) (Unaudited)
    Revenues:        
    Net product revenue $6,542  $8,351  $23,404  $23,763 
    Collaborative agreements  -   285,910   33   289,209 
    Royalties and other revenue  92   187   359   374 
    Total revenues  6,634   294,448   23,796   313,346 
    Operating expenses:        
    Cost of sales (including finite-lived intangible        
    asset amortization)  633   577   1,929   2,457 
    Research and development, including stock-based        
    compensation of $1,029, $1,698, $5,154 and $5,369, respectively  40,147   26,659   152,629   51,318 
    Selling, general and administrative, including stock-based        
    compensation of $875, $1,864, $5,440 and $5,370, respectively  11,997   13,898   40,798   42,271 
    Impairment loss on buildings  -   -   1,600   - 
    Impairment loss on intangible asset  -   28,638   -   28,638 
    Total operating expenses  52,777   69,772   196,956   124,684 
    Other operating income:        
    Gain on sale of XERMELO  132,818   -   132,818   - 
    Income (loss) from operations  86,675   224,676   (40,342)  188,662 
    Loss on debt extinguishments, net  (255)  -   (255)  - 
    Interest expense  (4,118)  (5,204)  (14,374)  (15,485)
    Interest and other income, net  301   600   1,892   2,080 
    Net income (loss) before income taxes  82,603   220,072   (53,079)  175,257 
    Income tax benefit  -   6,014   -   6,014 
    Net income (loss) $82,603  $226,086  $(53,079) $181,271 
             
    Net income (loss) per common share, basic $0.77  $2.13  $(0.50) $1.71 
    Net income (loss) per common share, diluted $0.71  $1.95  $(0.50) $1.59 
             
    Shares used in computing net income (loss) per common share, basic  107,309   106,272   106,974   106,200 
    Shares used in computing net income (loss) per common share, diluted  117,552   116,640   106,974   116,742 
             





       As of  As of
    Consolidated Balance Sheet Data Sept. 30, 2020  Dec. 31, 2019
    (In thousands) (Unaudited)  
    Cash and investments $111,446  $271,659 
    Property and equipment, net  11,106   14,047 
    Goodwill  44,543   44,543 
    Other intangible assets  -   19,716 
    Total assets  178,928   417,715 
    Current and long-term debt  20,320   245,183 
    Accumulated deficit  (1,394,523)  (1,341,444)
    Total stockholders' equity  87,639   117,101 

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Investor Relations

    Lexicon Pharmaceuticals

    (281) 863-3421

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  13. THE WOODLANDS, Texas, Sept. 23, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) announced today that it has entered into separate, privately-negotiated exchange agreements with certain holders of its 5.25% Convertible Senior Notes due 2021 under which such holders have agreed to exchange an aggregate principal amount of $62.55 million of Notes in exchange for aggregate consideration consisting of $41.03 million in cash (including $1.07 million of accrued interest) and 8,746,117 shares of Lexicon's common stock, par value $0.001 per share.

    The transactions are expected to close by September 28, 2020, subject to customary closing conditions. Immediately following the closings, $24.95 million in aggregate principal amount…

    THE WOODLANDS, Texas, Sept. 23, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) announced today that it has entered into separate, privately-negotiated exchange agreements with certain holders of its 5.25% Convertible Senior Notes due 2021 under which such holders have agreed to exchange an aggregate principal amount of $62.55 million of Notes in exchange for aggregate consideration consisting of $41.03 million in cash (including $1.07 million of accrued interest) and 8,746,117 shares of Lexicon's common stock, par value $0.001 per share.

    The transactions are expected to close by September 28, 2020, subject to customary closing conditions. Immediately following the closings, $24.95 million in aggregate principal amount of the Notes will remain outstanding.

    The completion of the transactions will reduce Lexicon's remaining interest expense through 2021 on the exchanged Notes by approximately $3.9 million. Once completed, and together with other debt reductions, including the repayment of Lexicon's secured loan concurrent with the closing of its sale of XERMELO® (telotristat ethyl) and related assets to TerSera Therapeutics, LLC, Lexicon will have reduced the principal amount of its outstanding debt by approximately 90% since June 30, 2020, better aligning with its strategic focus on its LX9211 neuropathic pain program and other research and development assets.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of the Company. The issuance of common stock has not been registered under the Securities Act of 1933 (the "Securities Act") or the securities laws of any other jurisdiction, and these securities may not be offered or sold in the United States absent registration or an applicable exemption from the Securities Act and applicable state laws.

    About LX9211

    LX9211 is a potent, orally delivered, selective small molecule inhibitor of AAK1, a target with a pain phenotype discovered and extensively characterized in an alliance with Bristol Myers Squibb. Preclinical studies of LX9211 demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways. Lexicon holds exclusive research, development and commercialization rights to LX9211 and additional compounds acting through AAK1 under the alliance.

    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 clinical and preclinical development in diabetes and metabolism, neuropathic pain 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, long-term outlook on its business and the clinical development and therapeutic and commercial potential of its 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, 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, 2019, 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.

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Patient Advocacy

    Lexicon Pharmaceuticals

    (281) 863-3421

     

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  14. Lexicon Receives $160.4 Million at Closing

    Eligible for Up to $65 Million in Milestone Payments Plus Mid-Teens Royalties on Net Sales of XERMELO in Biliary Tract Cancer

    Substantial Debt Reduction with Full Repayment of Secured Loan

    THE WOODLANDS, Texas, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) announced today the completion of the sale of Lexicon's rights, title and interest in XERMELO® (telotristat ethyl) to TerSera Therapeutics LLC. 

    Lexicon received $160.4 million in cash at closing, comprised of a $155 million upfront payment and additional payments for inventory and other closing considerations.  Lexicon may receive additional milestone payments of up to an aggregate of $65 million for the development…

    Lexicon Receives $160.4 Million at Closing

    Eligible for Up to $65 Million in Milestone Payments Plus Mid-Teens Royalties on Net Sales of XERMELO in Biliary Tract Cancer

    Substantial Debt Reduction with Full Repayment of Secured Loan

    THE WOODLANDS, Texas, Sept. 08, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) announced today the completion of the sale of Lexicon's rights, title and interest in XERMELO® (telotristat ethyl) to TerSera Therapeutics LLC. 

    Lexicon received $160.4 million in cash at closing, comprised of a $155 million upfront payment and additional payments for inventory and other closing considerations.  Lexicon may receive additional milestone payments of up to an aggregate of $65 million for the development and commercialization of telotristat ethyl in patients with biliary tract cancer.  Additionally, Lexicon will be eligible to receive mid-teens royalties on net sales of XERMELO in biliary tract cancer.  In connection with the transaction, TerSera offered employment to 28 Lexicon employees.  Lexicon plans to realign its business around its research and development assets, with a focus on its LX9211 neuropathic pain program, now in Phase 2 clinical development, while substantially reducing its debt by fully repaying its $150 million secured term loan.

    About LX9211

    LX9211 is a potent, orally delivered, selective small molecule inhibitor of AAK1, a target discovered and extensively characterized in an alliance with Bristol Myers Squibb. Preclinical studies of LX9211 demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways. Lexicon holds exclusive research, development and commercialization rights to LX9211 and additional compounds acting through AAK1 under the alliance.

    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 clinical and preclinical development in diabetes and metabolism, neuropathic pain 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 the sale of XERMELO (telotristat ethyl) and Lexicon's long-term outlook on its business.  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 conduct preclinical and clinical development and obtain necessary regulatory approvals of sotagliflozin, LX9211 and its other potential 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 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, 2019, 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.

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Patient Advocacy

    Lexicon Pharmaceuticals

    (281) 863-3421

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  15. THE WOODLANDS, Texas, Sept. 04, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today the commencement of patient dosing with blinded study drug in RELIEF-DPN-1, a Phase 2 randomized, placebo-controlled, multi-center clinical study of LX9211 for the treatment of diabetic peripheral neuropathic pain. LX9211 is a potent oral small molecule inhibitor of adaptor associated kinase 1 (AAK1).

    "We are pleased to progress with patient dosing in our first proof-of-concept study of LX9211, in patients with diabetic peripheral neuropathic pain," said Praveen Tyle, Ph.D., executive vice president of research and development. "Based on preclinical data, we believe that LX9211 has the potential to significantly reduce pain…

    THE WOODLANDS, Texas, Sept. 04, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today the commencement of patient dosing with blinded study drug in RELIEF-DPN-1, a Phase 2 randomized, placebo-controlled, multi-center clinical study of LX9211 for the treatment of diabetic peripheral neuropathic pain. LX9211 is a potent oral small molecule inhibitor of adaptor associated kinase 1 (AAK1).

    "We are pleased to progress with patient dosing in our first proof-of-concept study of LX9211, in patients with diabetic peripheral neuropathic pain," said Praveen Tyle, Ph.D., executive vice president of research and development. "Based on preclinical data, we believe that LX9211 has the potential to significantly reduce pain response without addictive properties while offering a novel therapeutic approach to neuropathic pain through inhibition of AAK1. We are preparing for an additional Phase 2 study in post-herpetic neuralgia that is expected to commence later this year and are evaluating opportunities in other areas of neuropathic pain, based on promising results in multiple preclinical models and a favorable Phase 1 clinical safety profile."

    About the RELIEF-DPN-1 Study

    RELIEF-DPN-1 is a Phase 2 randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy, safety and pharmacokinetics of LX9211 in the treatment of diabetic peripheral neuropathic pain. The study is designed to enroll approximately 300 patients at approximately 30 U.S. clinical sites. The primary efficacy endpoint under evaluation is the change from baseline (Day 1) to Week 6 in Average Daily Pain Score (ADPS), based on the 11-point numerical rating scale (NRS).

    About LX9211

    LX9211 is a potent, orally delivered, selective small molecule inhibitor of AAK1, a target discovered and extensively characterized in an alliance with Bristol Myers Squibb. Preclinical studies of LX9211 demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain without affecting opiate pathways. Lexicon holds exclusive research, development and commercialization rights to LX9211 and additional compounds acting through AAK1 under the alliance.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO®, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business and the clinical development and potential therapeutic and commercial potential of LX9211. 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 XERMELO (telotristat ethyl), successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, sotagliflozin, LX9211 and its other potential 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 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, 2019, 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.

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Patient Advocacy

    Lexicon Pharmaceuticals

    (281) 863-3421

    Primary Logo

    View Full Article Hide Full Article
  16. THE WOODLANDS, Texas, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced its participation in the following conferences:

    • Citi 15th Annual BioPharma Virtual Conference on Wednesday, September 9, 2020
    • Wells Fargo 2020 Virtual Healthcare Conference on Thursday, September 10, 2020

    Jeffrey L. Wade, Lexicon's executive vice president, corporate and administrative affairs and chief financial officer, will make a live webcast company presentation for the Wells Fargo conference on Thursday, September 10, 2020 at 2:00 p.m. ET.  The webcast will be available in the "Events" section of the Lexicon website at www.lexpharma.com. An archived version of the webcast will be available on the website for two weeks.

    THE WOODLANDS, Texas, Sept. 03, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced its participation in the following conferences:

    • Citi 15th Annual BioPharma Virtual Conference on Wednesday, September 9, 2020
    • Wells Fargo 2020 Virtual Healthcare Conference on Thursday, September 10, 2020

    Jeffrey L. Wade, Lexicon's executive vice president, corporate and administrative affairs and chief financial officer, will make a live webcast company presentation for the Wells Fargo conference on Thursday, September 10, 2020 at 2:00 p.m. ET.  The webcast will be available in the "Events" section of the Lexicon website at www.lexpharma.com. An archived version of the webcast will be available on the website for two weeks.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO®, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology, neuropathic pain 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 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 those relating to Lexicon's ability to meet its capital requirements, successfully conduct preclinical and clinical development of its drug candidates, obtain necessary regulatory approvals, 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, that 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, 2019, 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.

    For Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Patient Advocacy

    Lexicon Pharmaceuticals

    (281) 863-3421 

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  17. CHICAGO, Aug. 3, 2020 /PRNewswire/ -- GTCR, a leading private equity firm, announced today that its TerSera Therapeutics LLC ("TerSera") portfolio company has entered into a definitive agreement to acquire the product Xermelo® (telotristat ethyl) from Lexicon Pharmaceuticals, Inc. ((", Lexicon", , NASDAQ:LXRX) for an upfront purchase price of approximately $159 million plus potential milestone payments based on development and commercialization of Xermelo in a new indication.

    Xermelo is the first and only approved oral therapy for carcinoid syndrome diarrhea (CSD), a debilitating condition caused by metastatic neuroendocrine tumors. Xermelo was approved by the FDA in February 2017 for use in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. The product is also being investigated in a Phase 2 clinical study for the treatment of biliary tract cancer tumors.

    The add-on acquisition of Xermelo expands TerSera's existing oncology portfolio and is another example of the GTCR Leaders Strategy™ at work.  TerSera is GTCR's third partnership with Chairman and CEO Ed Fiorentino having previously partnered together to build Crealta Pharmaceuticals and Actient Pharmaceuticals.  Through a series of seven acquisitions since 2017, TerSera has built a portfolio of on-market and development assets focused on the therapeutic areas of oncology and non-opioid pain. The acquisition of Xermelo further expands the company's oncology franchise, which also includes the products Zoladex® (goserelin acetate implant) and Varubi® (rolapitant).

    "Xermelo is a great addition to the TerSera portfolio, which now includes six commercial products in two attractive therapeutic areas," said Dean Mihas, Managing Director at GTCR. "This acquisition further demonstrates our commitment to the Leaders Strategy, having partnered with Ed three times and built three unique, growing specialty pharmaceutical companies."

    Mr. Fiorentino added: "Xermelo continues to gain an increasingly important role in carcinoid syndrome diarrhea with a potential future role in other cancers. We are very excited to add Xermelo to our existing oncology portfolio and appreciate the support of GTCR as we've built another specialty pharmaceutical company focused on making a difference for patients."

    "With the addition of Xermelo, TerSera has become an even larger, more diversified specialty pharmaceutical business," noted Ben Daverman, Managing Director at GTCR. "We look forward to continuing to support Ed and the TerSera team as we further buildout the franchise and portfolio of unique, growing products."

    About GTCR

    Founded in 1980, GTCR is a leading private equity firm focused on investing in growth companies in the Healthcare, Financial Services & Technology, Technology, Media & Telecommunications, and Growth Business Services industries.  The Chicago-based firm pioneered The Leaders Strategy™ – finding and partnering with management leaders in core domains to identify, acquire and build market-leading companies through transformational acquisitions and organic growth.  Since its inception, GTCR has invested more than $18 billion in over 200 companies. For more information, please visit www.gtcr.com.

    About TerSera Therapeutics

    TerSera Therapeutics acquires, develops and markets specialty pharmaceutical products with a focus on oncology and non-opioid pain. Its mission is to provide products which truly make a difference for patients. For more information about TerSera Therapeutics, please visit www.tersera.com.

    About XERMELO (telotristat ethyl)

    XERMELO is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with mNETs and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

    XERMELO (telotristat ethyl) Important Safety Information

    • Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
    • Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
    • Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.

    For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

    Media Contact: Kellie Kennedy, 312-933-4903,

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/gtcr-and-tersera-therapeutics-announce-acquisition-of-xermelo-301104614.html

    SOURCE GTCR

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  18. Phase 2 Study for Diabetic Peripheral Neuropathic Pain Underway, Additional Studies Planned in Other Areas of Neuropathic Pain

    Sale of XERMELO to TerSera to Yield Up to $224 Million in Upfront and Milestone Payments Plus Mid-Teens Royalties on Net Sales of XERMELO in Biliary Tract Cancer

    Substantial Debt Reduction, Including Full Repayment of Secured Loan

    THE WOODLANDS, Texas, July 30, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) announced today that it is realigning its business around its research and development assets, with a focus on its LX9211 neuropathic pain program, now in Phase 2 clinical development.  In that regard:

    • Initiation of Phase 2 Clinical Development of LX9211. Lexicon has initiated patient screening…

    Phase 2 Study for Diabetic Peripheral Neuropathic Pain Underway, Additional Studies Planned in Other Areas of Neuropathic Pain

    Sale of XERMELO to TerSera to Yield Up to $224 Million in Upfront and Milestone Payments Plus Mid-Teens Royalties on Net Sales of XERMELO in Biliary Tract Cancer

    Substantial Debt Reduction, Including Full Repayment of Secured Loan

    THE WOODLANDS, Texas, July 30, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) announced today that it is realigning its business around its research and development assets, with a focus on its LX9211 neuropathic pain program, now in Phase 2 clinical development.  In that regard:

    • Initiation of Phase 2 Clinical Development of LX9211. Lexicon has initiated patient screening in RELIEF-DPN-1, a Phase 2 randomized, placebo-controlled, multi-center clinical study of LX9211 for the treatment of diabetic peripheral neuropathic pain that is expected to enroll approximately 300 patients at 30 U.S. sites. Lexicon is preparing for additional Phase 2 studies of LX9211, a potent oral small molecule inhibitor of adaptor associated kinase 1 (AAK1), in other areas of neuropathic pain based on promising results in multiple preclinical models of neuropathic pain and a favorable Phase 1 clinical safety profile.
    • Sale of XERMELO to TerSera. Lexicon entered into an asset purchase and sale agreement with TerSera Therapeutics LLC for the sale of Lexicon's XERMELO® (telotristat ethyl) product and related assets for up to $224 million in upfront and milestone payments, consisting of approximately $159 million in cash at closing and up to $65 million in development, regulatory and sales milestones relating to biliary tract cancer, plus eligibility for mid-teens royalties on net sales of XERMELO in biliary tract cancer.  As part of the transaction, TerSera has agreed to assume the currently ongoing TELE-ABC Phase 2 clinical study of XERMELO in biliary tract cancer patients and offer employment to at least 20 Lexicon employees currently dedicated to XERMELO. MTS Health Partners, L.P. served as financial advisor and WilmerHale served as legal counsel to Lexicon.
    • Debt Reduction. Lexicon will use the upfront proceeds from the XERMELO sale to substantially reduce its debt, including full repayment of its $150 million secured term loan.

    "We are implementing a strategic realignment of Lexicon around some truly compelling assets, with a focus on LX9211 for neuropathic pain and other early-stage research and development programs," said Lonnel Coats, Lexicon's president and chief executive officer. "The sale of our commercial product, XERMELO, to TerSera provides a home for an important treatment for patients with cancer as well as a number of our employees, allows us to use our resources more efficiently and dedicate appropriate investment to LX9211 development, and enables a substantial reduction of our debt."

    About the RELIEF-DPN-1 Study

    RELIEF-DPN-1 is a Phase 2 randomized, double-blind, placebo-controlled, parallel-group, multicenter study evaluating the efficacy, safety and pharmacokinetics of LX9211 in the treatment of diabetic peripheral neuropathic pain. The study is designed to enroll approximately 300 patients at approximately 30 U.S. clinical sites. The primary efficacy endpoint under evaluation is the change from baseline (Day 1) to Week 6 in Average Daily Pain Score (ADPS), based on the 11-point numerical rating scale (NRS).

    About LX9211

    LX9211 is a potent, orally delivered, selective small molecule inhibitor of AAK1, a target discovered and extensively characterized in an alliance with Bristol Myers Squibb. Preclinical studies of LX9211 demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain. Lexicon holds exclusive research, development and commercialization rights to LX9211 and additional compounds acting through AAK1 under the alliance.

    About XERMELO (telotristat ethyl)

    Discovered using Lexicon's unique approach to gene science, XERMELO is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with mNETs and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

    Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. Lexicon is commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.

    XERMELO (telotristat ethyl) Important Safety Information

    • Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
    • Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
    • Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.

    For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to the sale of XERMELO (telotristat ethyl) and Lexicon's long-term outlook on its business 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 complete the sale of XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of sotagliflozin, LX9211 and its other potential 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 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, 2019, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.

    Head of Investor Relations and Corporate Strategy

    Lexicon Pharmaceuticals

    (281) 863-3383

    For Media Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Patient Advocacy

    Lexicon Pharmaceuticals

    (281) 863-3421

     

    Primary Logo

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  19. THE WOODLANDS, Texas and DEERFIELD, Ill., July 30, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) and TerSera Therapeutics LLC announced today that they have entered into an asset purchase and sale agreement for the sale to TerSera of Lexicon's rights, title and interest in XERMELO® (telotristat ethyl).  

    Pursuant to the terms of the agreement, TerSera will pay Lexicon approximately $159 million in cash at closing, which includes a $155 million upfront payment and approximately $4 million for existing inventory.  Lexicon may receive additional development, regulatory and sales milestone payments of up to an aggregate of $65 million for the development and commercialization of telotristat ethyl in patients with biliary…

    THE WOODLANDS, Texas and DEERFIELD, Ill., July 30, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) and TerSera Therapeutics LLC announced today that they have entered into an asset purchase and sale agreement for the sale to TerSera of Lexicon's rights, title and interest in XERMELO® (telotristat ethyl).  

    Pursuant to the terms of the agreement, TerSera will pay Lexicon approximately $159 million in cash at closing, which includes a $155 million upfront payment and approximately $4 million for existing inventory.  Lexicon may receive additional development, regulatory and sales milestone payments of up to an aggregate of $65 million for the development and commercialization of telotristat ethyl in patients with biliary tract cancer.  Additionally, Lexicon will be eligible to receive mid-teens royalties on net sales of XERMELO in biliary tract cancer.  As part of the transaction, TerSera has agreed to assume the currently ongoing TELE-ABC Phase 2 clinical study of XERMELO in biliary tract cancer patients and offer employment to at least 20 Lexicon employees currently dedicated to XERMELO.  The transaction is expected to close in the third quarter of 2020, subject to customary closing conditions.

    "This agreement allows us to focus Lexicon around LX9211 for neuropathic pain and other early-stage research and development programs, enabling efficient use of our resources and substantially reducing our debt," said Lonnel Coats, Lexicon's president and chief executive officer. "TerSera's dedicated oncology focus will provide physicians and patients continued access to this important medicine for carcinoid syndrome diarrhea and continue its ongoing development for people suffering with biliary tract cancer."

    "XERMELO continues to gain an increasingly important role in carcinoid syndrome diarrhea with a potential future role in other cancers," said Ed Fiorentino, Chairman & CEO of TerSera. "We are very excited to add XERMELO to our existing oncology portfolio."

    About XERMELO (telotristat ethyl)

    Discovered using Lexicon's unique approach to gene science, XERMELO is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with mNETs and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

    Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. Lexicon is commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.

    XERMELO (telotristat ethyl) Important Safety Information

    • Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
    • Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
    • Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.

    For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    About TerSera Therapeutics

    TerSera Therapeutics acquires, develops and markets specialty pharmaceutical products with a focus on oncology and non-opioid pain.  Its mission is to provide products which truly make a difference for patients.  For more information about TerSera Therapeutics, please visit www.tersera.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to the sale of XERMELO (telotristat ethyl) and Lexicon's long-term outlook on its business. 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 complete the sale of XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of sotagliflozin, LX9211 and its other potential 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 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, 2019, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.

    Head of Investor Relations and Corporate Strategy

    Lexicon Pharmaceuticals

    (281) 863-3383

    For Media Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Patient Advocacy

    Lexicon Pharmaceuticals

    (281) 863-3421

    TerSera Therapeutics LLC Contact:

    Mark Leonard +1 847 651 9682 or

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  20. THE WOODLANDS, Texas, July 30, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today reported financial results and provided a business update for the three months ended June 30, 2020.

    "We achieved 21% growth in XERMELO net sales in the U.S. for the second quarter of 2020 compared to the prior-year period, underscoring the importance of our product to patients," said Lonnel Coats, Lexicon's president and chief executive officer. "In these unprecedented times of the COVID-19 pandemic, I am proud of the commitment and dedication of our employees to our mission to pioneer medicines to transform patients' lives. We continue to make progress on our pipeline with initiation of screening of patients in the Phase 2 RELIEF-DPN-1…

    THE WOODLANDS, Texas, July 30, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today reported financial results and provided a business update for the three months ended June 30, 2020.

    "We achieved 21% growth in XERMELO net sales in the U.S. for the second quarter of 2020 compared to the prior-year period, underscoring the importance of our product to patients," said Lonnel Coats, Lexicon's president and chief executive officer. "In these unprecedented times of the COVID-19 pandemic, I am proud of the commitment and dedication of our employees to our mission to pioneer medicines to transform patients' lives. We continue to make progress on our pipeline with initiation of screening of patients in the Phase 2 RELIEF-DPN-1 study for LX9211 in patients with diabetic peripheral neuropathic pain. We look forward to providing additional updates later this year."

    Second Quarter Product and Pipeline Highlights

    XERMELO® (telotristat ethyl)

    • XERMELO U.S. net sales were $9.0 million in the second quarter of 2020.
    • Telotristat ethyl's antiproliferative effects observed in a preclinical study in liposarcoma, colon cancer and cholangiocarcinoma cell lines were published online in conjunction with the American Society of Clinical Oncology (ASCO) 2020 annual meeting (May 29 - June 2, 2020).

    Sotagliflozin

    • Six posters for sotagliflozin were presented at the virtual 80th American Diabetes Association (ADA) Scientific Sessions (June 12-16, 2020) including additional efficacy and safety data in patients with type 2 diabetes and moderate and severe renal impairment.

    Second Quarter 2020 Financial Highlights

    Revenues: Revenues for the three months ended June 30, 2020 decreased to $9.2 million from $9.7 million for the corresponding period in 2019, primarily due to a decrease of bulk tablet sales of XERMELO to Ipsen and collaborative revenues, partially offset by an increase in U.S. net product revenue. Net product revenues for the three months ended June 30, 2020 consisted of $9.0 million from net sales of XERMELO in the U.S., up 21% from the prior year quarter.

    Cost of Sales: Cost of sales related to sales of XERMELO for the three months ended June 30, 2020 and 2019 was $0.7 million and $1.3 million, respectively.

    Research and Development (R&D) Expenses: Research and development expenses for the three months ended June 30, 2020 increased to $57.3 million from $12.6 million for the corresponding period in 2019, primarily due to increases in external clinical development costs related to sotagliflozin subsequent to the termination of the alliance with Sanofi.

    Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the three months ended June 30, 2020 were $14.1 million as compared to $14.3 million for the corresponding period in 2019.

    Net Loss: Net loss for the three months ended June 30, 2020 was $69.1 million, or $0.65 per share, as compared to a net loss of $23.0 million, or $0.22 per share, in the corresponding period in 2019. For the three months ended June 30, 2020 and 2019, net loss included non-cash, stock-based compensation expense of $4.3 million and $3.8 million, respectively.

    Cash and Investments: As of June 30, 2020, Lexicon had $201.9 million in cash and investments, as compared to $271.7 million as of December 31, 2019.

    Anticipated Near-Term Milestones

    • Q3 2020 – Dosing of first patient in the Phase 2 LX9211 study in diabetic peripheral neuropathic pain
    • Q4 2020 – Initiation of a Phase 2 study for LX9211 in post-herpetic neuralgia

    Conference Call and Webcast Information

    Lexicon management will hold a live conference call and webcast today at 8:00 am EDT / 7:00 am CDT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is 888-645-5785 (U.S./Canada) or 970-300-1531 (international). The conference ID for all callers is 4645277. The live webcast and replay may be accessed by visiting Lexicon's website at www.lexpharma.com/investors. An archived version of the webcast will be available on the website for 14 days.

    About XERMELO® (telotristat ethyl)

    Discovered using Lexicon's unique approach to gene science, XERMELO (telotristat ethyl) is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with mNETs and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

    Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. We are commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.

    XERMELO (telotristat ethyl) Important Safety Information

    • Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
    • Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
    • Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO. 

    For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

    About Sotagliflozin

    Discovered using Lexicon's unique approach to gene science, sotagliflozin is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Sotagliflozin is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business, including the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO (telotristat ethyl), sotagliflozin, and LX9211. 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 XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, sotagliflozin, LX9211 and its other potential 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 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, 2019, 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 June 30, Six Months Ended June 30,  
    (In thousands, except per share data) 2020 2019 2020 2019  
      (Unaudited) (Unaudited)  
    Revenues:          
    Net product revenue $8,985  $8,672  $16,862  $15,412   
    Collaborative agreements  25   860   33   3,299   
    Royalties and other revenue  153   150   267   187   
    Total revenues  9,163   9,682   17,162   18,898   
    Operating expenses:          
    Cost of sales (including finite-lived intangible          
      asset amortization)  728   1,327   1,296   1,880   
    Research and development, including stock-based          
      compensation of $1,949, $1,903, $4,125 and $3,671, respectively  57,301   12,637   112,482   24,659   
    Selling, general and administrative, including stock-based          
      compensation of $2,309, $1,863, $4,565 and $3,506, respectively  14,113   14,263   28,801   28,373   
    Impairment loss on buildings 1,600   -   1,600   -   
    Total operating expenses  73,742   28,227   144,179   54,912   
    Loss from operations  (64,579)  (18,545)  (127,017)  (36,014)  
    Interest expense  (5,125)  (5,164)  (10,256)  (10,281)  
    Interest and other income, net  633   691   1,591   1,480   
    Net loss $(69,071) $(23,018) $(135,682) $(44,815)  
               
    Net loss per common share, basic and diluted $(0.65) $(0.22) $(1.27) $(0.42)  
               
    Shares used in computing net loss per common share, basic          
    and diluted  107,073   106,272   106,804   106,164   
               
               
          As of As of  
    Consolidated Balance Sheet Data     June 30, 2020 December 31, 2019

      
    (In thousands)     (Unaudited)    
    Cash and investments   $201,866  $271,659   
    Property and equipment, net    11,524   14,047   
    Goodwill    44,543   44,543   
    Other intangible assets    18,833   19,716   
    Total assets    322,540   417,715   
    Current and long-term debt    245,264   245,183   
    Accumulated deficit    (1,477,126)  (1,341,444)  
    Total stockholders' equity/(deficit)  (10,687)  117,101   
               

    For Investor Inquiries:

    Kimberly Lee, D.O.

    Head of Investor Relations and Corporate Strategy

    Lexicon Pharmaceuticals

    (281) 863-3383

    For Media Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Patient Advocacy

    Lexicon Pharmaceuticals

    (281) 863-3421

    Primary Logo

    View Full Article Hide Full Article
  21. THE WOODLANDS, Texas, July 23, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), will release its second quarter 2020 financial results on Thursday, July 30, 2020 before market opens. Management will conduct a conference call and live webcast at 8:00 a.m. ET (7:00 a.m. CT) that day to discuss the financial results and to provide a business update.

    Dial-in Information
    U.S. Dial-in Number:  (888) 645-5785
    International Dial-in Number:  (970) 300-1531
    Conference ID:  4645277

    Replay Information
    U.S. Dial-in Number:  (855) 859-2056
    Replay International Dial-in Number:  (404) 537-3406
    Conference ID:  4645277

    The dial-in replay will be available for 14 days following the call. An audio webcast will be available online at www.lexpharma.com/events

    THE WOODLANDS, Texas, July 23, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), will release its second quarter 2020 financial results on Thursday, July 30, 2020 before market opens. Management will conduct a conference call and live webcast at 8:00 a.m. ET (7:00 a.m. CT) that day to discuss the financial results and to provide a business update.

    Dial-in Information

    U.S. Dial-in Number:  (888) 645-5785

    International Dial-in Number:  (970) 300-1531

    Conference ID:  4645277

    Replay Information

    U.S. Dial-in Number:  (855) 859-2056

    Replay International Dial-in Number:  (404) 537-3406

    Conference ID:  4645277

    The dial-in replay will be available for 14 days following the call. An audio webcast will be available online at www.lexpharma.com/events, with a webcast replay accessible for 14 days after the call.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business, including the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO (telotristat ethyl), sotagliflozin, and LX9211. 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 XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, sotagliflozin, LX9211 and its other potential 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 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, 2019, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.

    Head of Investor Relations and Corporate Strategy

    Lexicon Pharmaceuticals

    (281) 863-3383

    For Media Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Patient Advocacy

    Lexicon Pharmaceuticals

    (281) 863-3421

    Primary Logo

    View Full Article Hide Full Article
  22. THE WOODLANDS, Texas, July 21, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today announced topline data from four Phase 3 sotagliflozin studies in type 2 diabetes: SOTA-MONO, SOTA-SU, SOTA-GLIM and SOTA-INS. The final results of these studies will be preserved for upcoming medical congresses and publications.

    "We are pleased with the evidence of robust A1C reduction and long-term safety in patients with type 2 diabetes demonstrated in these studies," said Pablo Lapuerta, MD., executive vice president and chief medical officer at Lexicon. "We look forward to presenting and publishing detailed results from these studies in the future."

    All four Phase 3 sotagliflozin studies met their primary objectives of lowering…

    THE WOODLANDS, Texas, July 21, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today announced topline data from four Phase 3 sotagliflozin studies in type 2 diabetes: SOTA-MONO, SOTA-SU, SOTA-GLIM and SOTA-INS. The final results of these studies will be preserved for upcoming medical congresses and publications.

    "We are pleased with the evidence of robust A1C reduction and long-term safety in patients with type 2 diabetes demonstrated in these studies," said Pablo Lapuerta, MD., executive vice president and chief medical officer at Lexicon. "We look forward to presenting and publishing detailed results from these studies in the future."

    All four Phase 3 sotagliflozin studies met their primary objectives of lowering A1C in patients with type 2 diabetes.

    The observed safety profile of sotagliflozin in these studies was generally consistent with that of approved SGLT2 inhibitors. Diarrhea, an event consistent with gastrointestinal SGLT1 inhibition, was generally more common on sotagliflozin than placebo, although it was not a meaningful cause of treatment discontinuation. Genital mycotic infections were dose-related. The absolute increase in the incidence of genital mycotic infections over placebo ranged from 0% to 3.7% in studies of the 200 mg dose and from 3.2% to 6.3% in studies of the 400 mg dose. In one study, sotagliflozin showed less hypoglycemia than glimepiride, and in the other three studies, the incidences of hypoglycemia in patients on sotagliflozin were similar to those on placebo.

    Lexicon does not intend to pursue any regulatory approvals of sotagliflozin for type 2 diabetes in the absence of a strategic partnership for the commercialization of sotagliflozin in such indication.

    Phase 3 SOTA-MONO Study

    In the Phase 3, multicenter, randomized, double-blind, placebo-controlled SOTA-MONO study, sotagliflozin 400 mg and 200 mg as monotherapy was tested for superiority versus placebo in reducing A1C after 26 weeks of treatment in patients with type 2 diabetes and inadequate glycemic control. The study enrolled 142 patients on sotagliflozin 400 mg, 107 patients on sotagliflozin 200 mg and 150 patients on placebo.

    The study met its primary endpoint, demonstrating that sotagliflozin 400 mg and 200 mg significantly reduced A1C in patients with type 2 diabetes and inadequate glycemic control on diet and exercise alone.

    Safety results were similar to those in other studies of sotagliflozin in type 2 diabetes, with similar incidences of hypoglycemia on sotagliflozin and placebo.

    Phase 3 SOTA-SU Study

    SOTA-SU was a 507-patient, randomized, double-blind, placebo-controlled, parallel group, multicenter Phase 3 study that evaluated the efficacy and safety of sotagliflozin 400 mg added to a sulfonylurea, alone or in combination with metformin, in patients with type 2 diabetes who had inadequate glycemic control on a sulfonylurea or metformin alone. The primary endpoint was the change in A1C from baseline to Week 26. Patients were followed for a total of 79 weeks.

    The study met its primary endpoint, demonstrating that sotagliflozin 400 mg significantly reduced A1C in patients with type 2 diabetes who were on sulfonylurea alone or in combination with metformin with inadequate glycemic control on a sulfonylurea or metformin alone at Week 26. Importantly, A1C reduction persisted through 79 weeks.

    Safety results were similar to those in other studies of sotagliflozin in type 2 diabetes. Mean estimated glomerular filtration rate was estimated at Week 79, and was similar for sotagliflozin and placebo. Despite the presence of sulfonylurea background therapy, the incidences of hypoglycemia were similar on sotagliflozin and placebo.

    Phase 3 SOTA-GLIM Study

    SOTA-GLIM was a 954-patient, randomized, double-blind, double-dummy, active- and placebo-controlled, parallel group, multicenter Phase 3 study that evaluated the efficacy and safety of sotagliflozin 400 mg compared to glimepiride or placebo added to metformin in patients with type 2 diabetes who had inadequate glycemic control with metformin therapy. The primary objective of the study was to demonstrate the non-inferiority of sotagliflozin 400 mg compared to glimepiride on A1C at Week 52. Patients were followed for a total of 52 weeks.

    The study met its primary objective, as the change from baseline in A1C reduction to Week 52 was the same on sotagliflozin 400 mg and glimepiride, and the 95% confidence interval excluded the pre-specified margin (0.3%) of non-inferiority.

    Safety results were similar to those in other studies of sotagliflozin in type 2 diabetes, with less hypoglycemia on sotagliflozin than glimepiride.

    Phase 3 SOTA-INS Study

    SOTA-INS was a 571-patient, randomized, double-blind, placebo-controlled, parallel group, multicenter, 52-week Phase 3 study that evaluated the efficacy and safety of sotagliflozin 400 mg and 200 mg or placebo in patients with type 2 diabetes who had inadequate glycemic control on basal insulin alone or in addition to oral antidiabetic agents. The primary endpoint was a change in A1C from baseline to Week 18. Patients were followed for a total of 52 weeks.

    The study met its primary endpoint, demonstrating that sotagliflozin 400 mg and 200 mg significantly reduced A1C in patients with type 2 diabetes who had inadequate glycemic control on basal insulin alone or in addition to oral antidiabetic agents. Importantly, A1C reduction persisted at the same magnitude at 52 weeks.

    Safety results were similar to those in other studies of sotagliflozin in type 2 diabetes. Despite the presence of background insulin therapy, the incidences of hypoglycemia were similar on sotagliflozin and placebo.

    About Sotagliflozin

    Discovered using Lexicon's unique approach to gene science, sotagliflozin is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Sotagliflozin is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business, including the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO (telotristat ethyl), sotagliflozin, and LX9211. 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 XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, sotagliflozin, LX9211 and its other potential 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 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, 2019, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.

    Head of Investor Relations and Corporate Strategy

    Lexicon Pharmaceuticals

    (281) 863-3383

    For Media Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Patient Advocacy

    Lexicon Pharmaceuticals

    (281) 863-3421

    Primary Logo

    View Full Article Hide Full Article
  23. THE WOODLANDS, Texas, July 20, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today that four posters highlighting XERMELO® (telotristat ethyl) will be presented at the virtual Cholangiocarcinoma Foundation Annual Conference (July 22-24).

    Posters

    • Kim, R. et al.  Telotristat Ethyl and First-Line Chemotherapy for Advanced Biliary Tract Cancer (TELE-ABC):  Safety Results of a Phase 2 Trial
    • Kim, R. et al.  The TELE-ABC Clinical Trial:  A Novel Drug in Combination with Chemotherapy for Advanced Biliary Tract Cancer (Presentation at Patient Session)
    • Wilson, A. et al. Antitumor Activity of Telotristat Ethyl in Combination with Gemcitabine and Cisplatin in Tumor Cell Line Xenograft Models
    • Awasthi, N. et al.  Antitumor…

    THE WOODLANDS, Texas, July 20, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today that four posters highlighting XERMELO® (telotristat ethyl) will be presented at the virtual Cholangiocarcinoma Foundation Annual Conference (July 22-24).

    Posters

    • Kim, R. et al.  Telotristat Ethyl and First-Line Chemotherapy for Advanced Biliary Tract Cancer (TELE-ABC):  Safety Results of a Phase 2 Trial
    • Kim, R. et al.  The TELE-ABC Clinical Trial:  A Novel Drug in Combination with Chemotherapy for Advanced Biliary Tract Cancer (Presentation at Patient Session)
    • Wilson, A. et al. Antitumor Activity of Telotristat Ethyl in Combination with Gemcitabine and Cisplatin in Tumor Cell Line Xenograft Models
    • Awasthi, N. et al.  Antitumor Efficacy of Telotristat Ethyl in Combination with Cytotoxic Therapy in Preclinical Cholangiocarcinoma Models*

    *Investigator-initiated study (IIS) supported by a Lexicon Pharmaceuticals IIS grant

    About XERMELO (telotristat ethyl)

    Discovered using Lexicon's unique approach to gene science, XERMELO is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with mNETs and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

    Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. Lexicon is commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.

    XERMELO (telotristat ethyl) Important Safety Information

    • Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
    • Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
    • Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.

    For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business, including the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO (telotristat ethyl). 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 XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, sotagliflozin, LX9211 and its other potential 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 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, 2019, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.

    Head of Investor Relations and Corporate Strategy

    Lexicon Pharmaceuticals

    (281) 863-3383

    For Media Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Patient Advocacy

    Lexicon Pharmaceuticals

    (281) 863-3421

    Primary Logo

    View Full Article Hide Full Article
  24. THE WOODLANDS, Texas, June 13, 2020 (GLOBE NEWSWIRE) --  Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today presented six posters for ZynquistaTM (sotagliflozin) at the virtual 80th American Diabetes Association (ADA) Scientific Sessions including additional efficacy and safety data patients with type 2 diabetes and moderate and severe renal impairment.

    Phase 3 CKD-3 Study

    In the Phase 3, multicenter, randomized, double-blind, placebo-controlled CKD-3 study, sotagliflozin was tested for superiority versus placebo in reducing A1C after 26 weeks of treatment in patients with type 2 diabetes, inadequate glycemic control and moderate (CKD Stage 3) renal impairment.

    The study met its primary endpoint, demonstrating that sotagliflozin 400 mg…

    THE WOODLANDS, Texas, June 13, 2020 (GLOBE NEWSWIRE) --  Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today presented six posters for ZynquistaTM (sotagliflozin) at the virtual 80th American Diabetes Association (ADA) Scientific Sessions including additional efficacy and safety data patients with type 2 diabetes and moderate and severe renal impairment.

    Phase 3 CKD-3 Study

    In the Phase 3, multicenter, randomized, double-blind, placebo-controlled CKD-3 study, sotagliflozin was tested for superiority versus placebo in reducing A1C after 26 weeks of treatment in patients with type 2 diabetes, inadequate glycemic control and moderate (CKD Stage 3) renal impairment.

    The study met its primary endpoint, demonstrating that sotagliflozin 400 mg significantly reduced A1C in the entire population of patients with moderate renal impairment compared to placebo at Week 26. The difference in least squares (LS) mean change in A1C from baseline for patients treated with sotagliflozin 400 mg compared to placebo was -0.24% (p = 0.0021). The change in A1C from baseline was not statistically different in patients treated with sotagliflozin 200 mg compared to placebo (p = 0.2085).

    The safety profile of sotagliflozin was generally similar to that of placebo. Incidences of symptomatic hypoglycemia (with documented blood glucose ≤70 mg/dL) were 20.4% on sotagliflozin 400 mg, 27.3% on sotagliflozin 200 mg, and 25.0% on placebo. The rates of symptomatic hypoglycemia (per 100 patient years of exposure) were 114.0 on sotagliflozin 400 mg, 140.5 on sotagliflozin 200 mg, and 175.4 on placebo.

    Phase 3 CKD-4 Study

    In the Phase 3, multicenter, randomized, double-blind, placebo-controlled CKD-4 study, sotagliflozin was tested for superiority versus placebo in reducing A1C after 26 weeks of treatment in patients with type 2 diabetes, inadequate glycemic control and severe (CKD Stage 4) renal impairment.

    The study did not meet its primary endpoint of demonstrating superiority of sotagliflozin versus placebo on A1C reduction after 26 weeks of treatment in patients with type 2 diabetes, inadequate glycemic control and severe renal impairment compared to placebo. The placebo-adjusted difference in A1C from baseline for patients treated with sotagliflozin 400 mg compared to placebo was -0.29% (p = 0.0962) at week 26. For sotagliflozin 200 mg, the placebo-adjusted difference in A1C was 0.05% (p = 0.8124).

    Several findings indicated clinically meaningful glycemic control over time was achieved with sotagliflozin 400 mg. From baseline to Week 52, the placebo-subtracted A1C reduction for sotagliflozin 400 mg was -0.69% (95% confidence interval: -0.23, -1.15). At Week 52, achievement of A1C ≤ 7% was seen in 20.7% of patients on sotagliflozin 400 mg compared to 6.5% on placebo. Over 52 weeks, the incidence of rescue therapy to treat hyperglycemia was 7.6% on sotagliflozin 400 mg and 15.1% on placebo. Results were consistent with a dose related-response, as the 200 mg dose group at Week 52 had a placebo-subtracted A1C reduction of -0.32%, 19.6% of patients achieved A1C ≤ 7%, and 10.9% required rescue therapy.

    The safety profile of sotagliflozin was generally similar to that of placebo. This was a population at high cardiovascular risk, and the incidences of major adverse cardiovascular events (myocardial infarction, stroke, and cardiovascular death) were 4.4% on sotagliflozin 400 mg, 1.1% on sotagliflozin 200 mg, and 11.9% on placebo. Incidences of symptomatic hypoglycemia (with documented blood glucose ≤70 mg/dL) were 27.8% on sotagliflozin 400 mg, 28.7% on sotagliflozin 200 mg and 35.5% on placebo, and the rates (per 100 patient years of exposure) were 171.6 on sotagliflozin 400 mg, 226.9 on sotagliflozin 200 mg, and 269.8 on placebo.

    Additional poster presentations

    • Effects of sotagliflozin added to insulin therapy on beta-hydroxybutyrate in patients with type 1 diabetes. Peters, D. et al.
    • Efficacy and safety of sotagliflozin by baseline renal function in adults with type 1 diabetes. Handelsman, Y. et al.
    • Balancing the risk of DKA and severe hypoglycemia with sotagliflozin in adults with type 1 diabetes. Pettus, J. et al.
    • Impact of treatment with sotagliflozin on the incidence of severe hypoglycemia in patients with T1D. Pettus, J.

    About Sotagliflozin

    Discovered using Lexicon's unique approach to gene science, sotagliflozin is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Sotagliflozin is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business, including the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO (telotristat ethyl), Zynquista (sotagliflozin), and LX9211. 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 XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, sotagliflozin, LX9211 and its other potential 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 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, 2019, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.

    Head of Investor Relations and Corporate Strategy

    Lexicon Pharmaceuticals

    (281) 863-3383

    For Media Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Patient Advocacy

    Lexicon Pharmaceuticals

    (281) 863-3421

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  25. THE WOODLANDS, Texas, May 13, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today additional data on XERMELO's® (telotristat ethyl) antiproliferative effects against cultured liposarcoma, colon cancer and cholangiocarcinoma cell lines that were published online in conjunction with the American Society of Clinical Oncology (ASCO) 2020 annual meeting (May 29 - June 2, 2020). XERMELO is approved for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy, but is not currently approved for any other use.

    Tumor growth inhibition when exposed to telotristat ethyl was most pronounced in the liposarcoma cell line, followed…

    THE WOODLANDS, Texas, May 13, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today additional data on XERMELO's® (telotristat ethyl) antiproliferative effects against cultured liposarcoma, colon cancer and cholangiocarcinoma cell lines that were published online in conjunction with the American Society of Clinical Oncology (ASCO) 2020 annual meeting (May 29 - June 2, 2020). XERMELO is approved for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy, but is not currently approved for any other use.

    Tumor growth inhibition when exposed to telotristat ethyl was most pronounced in the liposarcoma cell line, followed by the colon cancer and cholangiocarcinoma cell lines. 

    "We are pleased that this preclinical study demonstrated that telotristat ethyl has antitumor effect in various cancer types," said Praveen Tyle, Ph.D, executive vice president, research and development of Lexicon. "Today's data support the conduct of additional studies to examine telotristat ethyl's effect on tryptophan hydroxylase positive cancers."

    About XERMELO (telotristat ethyl)

    Discovered using Lexicon's unique approach to gene science, XERMELO is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with SSA therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with mNETs and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

    Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. Lexicon is commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.

    XERMELO (telotristat ethyl) Important Safety Information

    • Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
    • Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
    • Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.

    For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business, including the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO (telotristat ethyl). 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 XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, sotagliflozin, LX9211 and its other potential 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 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, 2019, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.
    Head of Investor Relations and Corporate Strategy
    Lexicon Pharmaceuticals
    (281) 863-3383

    For Media Inquiries:

    Chas Schultz
    Executive Director, Corporate Communications and Patient Advocacy
    Lexicon Pharmaceuticals
    (281) 863-3421

     

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  26. THE WOODLANDS, Texas, April 07, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) will host its 2020 annual meeting of stockholders in a virtual format only due to the public health impact of the coronavirus pandemic and to prioritize the health and well-being of meeting participants.

    The virtual 2020 annual meeting of stockholders will be held at 8:00 a.m. CT on April 23, 2020.

    Stockholders at the close of business on the record date, February 24, 2020, are entitled to attend the annual meeting. The link to the meeting will be available at www.virtualshareholdermeeting.com/LXRX2020. Shareholders must enter the 16-digit voting control number found on their proxy card, voting instruction form, notice of internet availability…

    THE WOODLANDS, Texas, April 07, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) will host its 2020 annual meeting of stockholders in a virtual format only due to the public health impact of the coronavirus pandemic and to prioritize the health and well-being of meeting participants.

    The virtual 2020 annual meeting of stockholders will be held at 8:00 a.m. CT on April 23, 2020.

    Stockholders at the close of business on the record date, February 24, 2020, are entitled to attend the annual meeting. The link to the meeting will be available at www.virtualshareholdermeeting.com/LXRX2020. Shareholders must enter the 16-digit voting control number found on their proxy card, voting instruction form, notice of internet availability of proxy materials or email previously received.

    Please note that the proxy card and voting instruction form included with previously-distributed proxy materials will not be updated to reflect the change from an in-person meeting to a virtual-only meeting and may be used to vote shares in connection with the annual meeting.

    Whether or not shareholders plan to attend the virtual-only annual meeting, Lexicon urges shareholders to vote and submit their proxies in advance of the meeting by one of the methods described in the proxy materials.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business, including the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO (telotristat ethyl), Zynquista (sotagliflozin), and LX9211. 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 XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, sotagliflozin, LX9211 and its other potential 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 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, 2019, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.

    Head of Investor Relations and Corporate Strategy

    Lexicon Pharmaceuticals

    (281) 863-3383

    For Media Inquiries:

    Chas Schultz

    Executive Director, Corporate Communications and Patient Advocacy

    Lexicon Pharmaceuticals

    (281) 863-3421

    Primary Logo

    View Full Article Hide Full Article
  27. THE WOODLANDS, Texas, March 13, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today additional data on XERMELO's® (telotristat ethyl) antiproliferative effects in patients with carcinoid syndrome that were presented at the European Neuroendocrine Tumor Society (ENETS) meeting (March 11-13). XERMELO is approved for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy, but is not currently approved for any other use.

    Data from a retrospective, pre- and post-design chart review of 200 metastatic neuroendocrine tumor patients who were on standard background therapies and received telotristat ethyl for an average of 12…

    THE WOODLANDS, Texas, March 13, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today additional data on XERMELO's® (telotristat ethyl) antiproliferative effects in patients with carcinoid syndrome that were presented at the European Neuroendocrine Tumor Society (ENETS) meeting (March 11-13). XERMELO is approved for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy, but is not currently approved for any other use.

    Data from a retrospective, pre- and post-design chart review of 200 metastatic neuroendocrine tumor patients who were on standard background therapies and received telotristat ethyl for an average of 12 months in US clinical practice demonstrated that most patients had no tumor progression at 6, 12 and 18 months following initiation of telotristat ethyl, with a median time to tumor progression (TTP) of 39.8 months. The majority of patients also experienced progression-free survival (PFS) in the post-telotristat ethyl period, with a median PFS of 23.7 months. In addition, in a subset of 22 patients with recorded biomarker data, mean serotonin levels decreased significantly in the post-telotristat ethyl period. Patients also improved on carcinoid syndrome (CS) symptoms, body weight and performance status.

    "We are pleased this observational study showed that use of telotristat ethyl was associated with not only neuroendocrine tumor control but also meaningful improvements in CS symptoms and clinical indicators of overall health in patients with advanced neuroendocrine tumors and carcinoid syndrome," said Pablo Lapuerta, executive vice president and chief medical officer of Lexicon. "Results of this observational study coupled with preclinical data support the conduct of clinical trials to examine telotristat ethyl's effect on neuroendocrine tumors."

    About XERMELO (telotristat ethyl)

    Discovered using Lexicon's unique approach to gene science, XERMELO is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with SSA therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with mNETs and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

    Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. Lexicon is commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.

    XERMELO (telotristat ethyl) Important Safety Information

    • Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
    • Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
    • Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.

    For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business, including the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO (telotristat ethyl). 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 XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, sotagliflozin, LX9211 and its other potential 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 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, 2019, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.
    Head of Investor Relations and Corporate Strategy
    Lexicon Pharmaceuticals
    (281) 863-3383

    For Media Inquiries:

    Chas Schultz
    Executive Director, Corporate Communications and Patient Advocacy
    Lexicon Pharmaceuticals
    (281) 863-3421
     

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  28. XERMELO® (telotristat ethyl) 2019 U.S. Net Sales Reached $31.0 Million

    THE WOODLANDS, Texas, March 12, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today reported financial results for the three months and full-year ended December 31, 2019 and provided a business update.

    "In 2019, we achieved continued growth in our XERMELO (telotristat ethyl) business of nearly 25% year-over-year and made significant strides in advancing pipeline initiatives such as telotristat ethyl in biliary tract cancer and LX9211 in neuropathic pain," said Lonnel Coats, Lexicon's president and chief executive officer. "We expect initial clinical efficacy data for telotristat ethyl in biliary tract cancer by the end of this year. As for LX9211…

    XERMELO® (telotristat ethyl) 2019 U.S. Net Sales Reached $31.0 Million

    THE WOODLANDS, Texas, March 12, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today reported financial results for the three months and full-year ended December 31, 2019 and provided a business update.

    "In 2019, we achieved continued growth in our XERMELO (telotristat ethyl) business of nearly 25% year-over-year and made significant strides in advancing pipeline initiatives such as telotristat ethyl in biliary tract cancer and LX9211 in neuropathic pain," said Lonnel Coats, Lexicon's president and chief executive officer. "We expect initial clinical efficacy data for telotristat ethyl in biliary tract cancer by the end of this year. As for LX9211, we are initiating a proof-of-concept study in diabetic peripheral neuropathic pain in the first half of this year."

    "We received a response yesterday from the Center for Drug Evaluation and Research (CDER) to our appeal of the FDA's complete response letter (CRL) for sotagliflozin in type 1 diabetes," continued Mr. Coats.  "The response confirmed the CRL decision, and we are now evaluating the feedback they provided in their response."

    "We are engaged in discussions around potential partnerships for sotagliflozin, which will be necessary to enable completion of the long-term outcomes studies, SCORED and SOLOIST, that are designed to demonstrate benefits in and support labeling for heart failure and chronic kidney disease."

    Fourth Quarter and Full-Year 2019 Product and Pipeline Highlights

    XERMELO® (telotristat ethyl)

    • XERMELO U.S. net sales were $31.0 million in 2019.
    • In December, Lexicon completed a safety review of the initial safety run-in cohort of The Telotristat Ethyl for Advanced Biliary Tract Cancer, or TELE-ABC, study, a Phase 2a clinical study of telotristat ethyl in patients with biliary tract cancer. Safety analysis from the first six patients who completed at least a 21-day cycle of treatment with telotristat ethyl in combination with cisplatin and gemcitabine supported the continuation of enrollment with no adjustment in the telotristat ethyl 500 mg three times daily dosing regimen.

    Zynquista™ (sotagliflozin)

    • In December, Lexicon announced topline data from the Phase 3 SOTA-EMPA study of sotagliflozin in type 2 diabetes. Sotagliflozin 400 mg achieved the primary endpoint of superiority on A1C reduction versus placebo at Week 26 in patients with inadequate glycemic control while on a dipeptidyl peptidase 4 inhibitor, with or without metformin therapy. Sotagliflozin 400mg also achieved the key secondary endpoint of noninferiority versus empagliflozin on A1C reduction from baseline at Week 26. Sotagliflozin was generally well tolerated, with safety results comparable to previously reported safety results in patients with type 2 diabetes.
       
    • In December, Lexicon announced that the U.S. Food and Drug Administration's (FDA) Office of New Drugs had reiterated the FDA's prior position that the New Drug Application for sotagliflozin in type 1 diabetes cannot be approved in its present form and denied the appeal of the previously issued CRL. Lexicon subsequently appealed the decision to CDER. As indicated above, CDER yesterday reaffirmed the FDA's position.

    LX9211

    • Lexicon announced positive topline Phase 1 data for LX9211 in a multiple ascending dose study in healthy volunteers that demonstrated a favorable safety and pharmacokinetics profile supportive of once-daily dosing.

    Fourth Quarter and Full-Year 2019 Financial Highlights

    Unless otherwise stated, all comparisons are for the fourth quarter and full year of 2019 compared to the fourth quarter and full year of 2018.

    Revenues: Revenues for the fourth quarter decreased to $8.7 million from $17.1 million for the corresponding period in 2018, primarily due to lower revenues recognized under collaboration and license agreements. Full-year 2019 revenues increased to $322.1 million from $63.2 million, primarily due to collaboration revenues recognized from the termination of the alliance with Sanofi and recognition of remaining amounts allocated to the performance obligations from the initial Sanofi collaboration agreement for development activities relating to sotagliflozin, as well as an increase from net product revenue. Net product revenues for full-year 2019 included $31.0 million and $1.3 million, respectively, from net sales of XERMELO in the U.S. and the sale of bulk tablets to Lexicon's collaborator, Ipsen.

    Cost of Sales: Cost of sales related to sales of XERMELO was $0.7 million and $0.6 million, respectively, for the fourth quarter of 2019 and 2018. Full-year 2019 and 2018 cost of sales was $3.2 million and $2.5 million, respectively.

    Research and Development (R&D) Expenses: Research and development expenses for the fourth quarter increased to $40.6 million from $12.3 million for the corresponding period in 2018, primarily due to increases in external clinical development costs relating to sotagliflozin subsequent to Lexicon regaining the rights and responsibilities for development and commercialization of sotagliflozin pursuant to the termination of the Sanofi alliance. Full-year R&D expenses for 2019 decreased to $91.9 million from $100.2 million, due to decreases in professional and consulting fees and lower external clinical development costs.

    Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the fourth quarter were $14.6 million compared to $16.6 million for the same period in 2018. Full-year 2019 SG&A expenses decreased to $56.8 million from $63.8 million, primarily due to lower marketing expenses and professional and consulting costs.

    Impairment Loss on Intangible Asset: An impairment loss in 2019 of $28.6 million was recognized to an indefinite lived intangible asset associated with Lexicon's 2010 acquisition of Symphony Icon, due to the decision to terminate research and development activities related to a program for irritable bowel syndrome that was among the assets acquired.

    Income Tax Benefit: An income tax benefit of $6.0 million in 2019 was recognized in connection with the impairment loss on the indefinite lived intangible asset, which resulted in a decrease to the deferred tax liability and created an income tax benefit.  During 2018, there was no income tax benefit.

    Net Income (Loss): Net loss for the fourth quarter was $51.1 million, or $0.48 per share, as compared to a net loss of $16.8 million, or $0.16 per share, in the corresponding period in 2018. For the fourth quarter 2019, net loss included non-cash, stock-based compensation expense of $3.5 million. For the fourth quarter 2018, net loss included non-cash, stock-based compensation expense of $2.8 million. Net income for the full-year 2019 was $130.1 million, or $1.16 per diluted share, as compared to a net loss of $120.5 million, or $1.14 per share, in 2018. For the full-year 2019, net income included non-cash, stock-based compensation expense of $14.2 million. For the full-year 2018, net loss included non-cash, stock-based compensation expense of $11.7 million.

    Cash and Investments: As of December 31, 2019, Lexicon had $271.7 million in cash and investments, as compared to $160.1 million as of December 31, 2018.

    Anticipated Near-Term Milestones

    • H1 2020 – Initiation of a Phase 2 study for LX9211 in diabetic peripheral neuropathic pain
    • H1 2020 – Completion of patient enrollment in the first efficacy cohort of the Phase 2 study of telotristat ethyl in biliary tract cancer
    • H1 2020 – Topline results from core Phase 3 sotagliflozin studies in type 2 diabetes
    • June 2020 – Presentation of Phase 3 data for sotagliflozin in type 2 diabetes at the 80th Scientific Sessions of the American Diabetes Association (ADA)
    • September 2020 – Presentation of Phase 3 data for sotagliflozin in type 2 diabetes at the 56th Annual Meeting of the European Association for the Study of Diabetes (EASD)
    • Q4 2020 – Data from the first efficacy cohort of the Phase 2 study of telotristat ethyl in biliary tract cancer

    Conference Call and Webcast Information

    Lexicon management will hold a live conference call and webcast today at 8:00 am ET / 7:00 am CT to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is 888-645-5785 (U.S./Canada) or 970-300-1531 (international). The conference ID for all callers is 4187725. The live webcast and replay may be accessed by visiting Lexicon's website at www.lexpharma.com/investors. An archived version of the webcast will be available on the website for 14 days.

    About XERMELO (telotristat ethyl)

    Discovered using Lexicon's unique approach to gene science, XERMELO (telotristat ethyl) is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with mNETs and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

    Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. We are commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.

    XERMELO (telotristat ethyl) Important Safety Information

    • Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
    • Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
    • Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO. 

    For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

    About Zynquista (sotagliflozin)

    Discovered using Lexicon's unique approach to gene science, Zynquista is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Zynquista is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy. Outside of such approval, Zynquista is investigational and has not been approved by any other regulatory authority for type 1 or type 2 diabetes.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business, including the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO (telotristat ethyl), Zynquista (sotagliflozin), and LX9211. 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 XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, sotagliflozin, LX9211 and its other potential 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 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, 2018, 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 December 31,   Year Ended December 31,
    (In thousands, except per share data)   2019   2018   2019   2018
        (Unaudited)       (Unaudited)    
             
    Revenues:                
    Net product revenue    $ 8,568     $ 7,521     $ 32,331     $ 26,583  
    Collaborative agreements     22       9,479       289,231       36,271  
    Royalties and other revenue      137       71       511       355  
    Total revenues      8,727       17,071       322,073       63,209  
    Operating expenses:                
    Cost of sales (including finite-lived intangible                
    asset amortization)     774       569       3,231       2,491  
    Research and development, including stock-based compensation                
    of $1,727, $1,488, $7,096 and $6,010, respectively      40,606       12,307       91,924       100,243  
    Selling, general and administrative, including stock-based compensation                
    of $1,752, $1,359, $7,122 and $5,686, respectively     14,564       16,562       56,835       63,754  
    Impairment loss on intangible asset     -       -       28,638       -  
    Total operating expenses      55,944       29,438       180,628       166,488  
    Income (loss) from operations      (47,217 )     (12,367 )     141,445       (103,279 )
    Interest expense      (5,191 )     (5,224 )     (20,676 )     (20,777 )
    Interest and other income, net     1,270       810       3,350       3,508  
    Net income (loss) before income taxes     (51,138 )     (16,781 )     124,119       (120,548 )
    Income tax benefit     -       -       6,014       -  
    Net income (loss)   $ (51,138 )   $ (16,781 )   $ 130,133     $ (120,548 )
                     
                     
    Net income (loss) per common share, basic   $ (0.48 )   $ (0.16 )   $ 1.23     $ (1.14 )
    Net income (loss) per common share, diluted   $ (0.48 )   $ (0.16 )   $ 1.16     $ (1.14 )
                     
    Shares used in computing net income (loss) per                
    common share, basic     106,272       105,920       106,218       105,830  
    Shares used in computing net income (loss) per                
    common share, diluted     106,272       105,920       116,747       105,830  
                     
    Consolidated Balance Sheet Data           As of December 31, 2019   As of December 31, 2018
    (In thousands)           (Unaudited)    
                     
    Cash and investments           $ 271,659     $ 160,052  
    Property and equipment, net             14,047       15,865  
    Goodwill             44,543       44,543  
    Other intangible assets             19,716       50,119  
    Total assets             417,715       284,136  
    Deferred revenue             -       25,990  
    Current and long-term debt             245,183       245,002  
    Accumulated deficit             (1,341,444 )     (1,471,577 )
    Total stockholders' equity (deficit)              117,101       (26,405 )

    For Investor Inquiries:

    Kimberly Lee, D.O.
    Head of Investor Relations and Corporate Strategy
    Lexicon Pharmaceuticals
    (281) 863-3383

    For Media Inquiries:

    Chas Schultz
    Executive Director, Corporate Communications and Patient Advocacy
    Lexicon Pharmaceuticals
    (281) 863-3421

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  29. THE WOODLANDS, Texas, March 05, 2020 (GLOBE NEWSWIRE) --  Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), will release its fourth quarter and full-year 2019 financial results on Thursday, March 12, 2020 before market opens. Management will conduct a conference call and live webcast at 8:00 a.m. EST (7:00 a.m. CST) that day to discuss the financial results and to provide a business update.

    Dial-in Information
    U.S. Dial-in Number:  (888) 645-5785
    International Dial-in Number:  (970) 300-1531
    Conference ID:  4187725

    Replay Information
    U.S. Dial-in Number:  (855) 859-2056
    Replay International Dial-in Number:  (404) 537-3406
    Conference ID:  4187725

    The dial-in replay will be available for 7 days following the call. An audio webcast will be available online…

    THE WOODLANDS, Texas, March 05, 2020 (GLOBE NEWSWIRE) --  Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), will release its fourth quarter and full-year 2019 financial results on Thursday, March 12, 2020 before market opens. Management will conduct a conference call and live webcast at 8:00 a.m. EST (7:00 a.m. CST) that day to discuss the financial results and to provide a business update.

    Dial-in Information
    U.S. Dial-in Number:  (888) 645-5785
    International Dial-in Number:  (970) 300-1531
    Conference ID:  4187725

    Replay Information
    U.S. Dial-in Number:  (855) 859-2056
    Replay International Dial-in Number:  (404) 537-3406
    Conference ID:  4187725

    The dial-in replay will be available for 7 days following the call. An audio webcast will be available online in the investor relations section of the company website at www.lexpharma.com/investors, with a webcast replay accessible for 14 days after the call.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business, including the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO (telotristat ethyl), Zynquista (sotagliflozin), and LX9211. 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 XERMELO, successfully complete the transition from Sanofi of responsibility for ongoing clinical studies and other activities relating to sotagliflozin, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, sotagliflozin, LX9211 and its other potential 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 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, 2018, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.
    Head of Investor Relations and Corporate Strategy
    Lexicon Pharmaceuticals
    (281) 863-3383

    For Media Inquiries:

    Chas Schultz
    Executive Director, Corporate Communications and Patient Advocacy
    Lexicon Pharmaceuticals
    (281) 863-3421

    Primary Logo

    View Full Article Hide Full Article
  30. THE WOODLANDS, Texas, Jan. 24, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today real-world data on XERMELO's® (telotristat ethyl) antiproliferative effects in patients with carcinoid syndrome that were presented at the American Society for Clinical Oncology (ASCO) 2020 Symposium (January 23-25, San Francisco, CA). XERMELO is approved for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy, but is not currently approved for any other use.

    Data from a retrospective, pre- and post-design chart review of 200 metastatic neuroendocrine tumor patients who were on standard background therapies and received telotristat…

    THE WOODLANDS, Texas, Jan. 24, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today real-world data on XERMELO's® (telotristat ethyl) antiproliferative effects in patients with carcinoid syndrome that were presented at the American Society for Clinical Oncology (ASCO) 2020 Symposium (January 23-25, San Francisco, CA). XERMELO is approved for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy, but is not currently approved for any other use.

    Data from a retrospective, pre- and post-design chart review of 200 metastatic neuroendocrine tumor patients who were on standard background therapies and received telotristat ethyl for an average of 12 months in US clinical practice demonstrated significant mean tumor size reduction of 0.59 cm after initiation of telotristat ethyl (p = 0.006).

    "We are pleased this observational study showed that use of telotristat ethyl was associated with neuroendocrine tumor control," said Pablo Lapuerta, executive vice president and chief medical officer of Lexicon. "These findings are consistent with preclinical data suggesting that serotonin may promote tumor growth. Such preclinical data and the results of this observational study support the conduct of clinical trials to examine telotristat ethyl's effect on neuroendocrine tumors."

    About XERMELO (telotristat ethyl)

    Discovered using Lexicon's unique approach to gene science, XERMELO is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with SSA therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with mNETs and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

    Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. Lexicon is commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.

    XERMELO (telotristat ethyl) Important Safety Information

    • Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
    • Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
    • Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.

    For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business, including the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO (telotristat ethyl). 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 XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, sotagliflozin, LX9211 and its other potential 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 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, 2018, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.
    Head of Investor Relations and Corporate Strategy
    Lexicon Pharmaceuticals
    (281) 863-3383

    For Media Inquiries:

    Chas Schultz
    Executive Director, Corporate Communications and Patient Advocacy
    Lexicon Pharmaceuticals
    (281) 863-3421

    Primary Logo

    View Full Article Hide Full Article
  31. THE WOODLANDS, Texas, Jan. 20, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today that data from a poster highlighting XERMELO® (telotristat ethyl) will be presented at the American Society for Clinical Oncology (ASCO) 2020 Symposium (January 23-25, San Francisco, CA).

    Poster Presentation (all times local)

    Friday, January 24, 12:00 pm-1:30 pm, 4:30 pm-5:30 pm

    • Morse, M. et al. Exploring telotristat ethyl's antiproliferative effects in patients with carcinoid syndrome (TELEACE): A real-world observational study (Abstract #618; Poster Board: F21)                   

    About XERMELO (telotristat ethyl)

    Discovered using Lexicon's unique approach to gene science, XERMELO is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with mNETs and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

    Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. Lexicon is commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.

    XERMELO (telotristat ethyl) Important Safety Information

    • Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
    • Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
    • Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.

    For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business, including the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO (telotristat ethyl). 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 XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, sotagliflozin, LX9211 and its other potential 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 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, 2018, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.
    Head of Investor Relations and Corporate Strategy
    Lexicon Pharmaceuticals
    (281) 863-3383

    For Media Inquiries:

    Chas Schultz
    Executive Director, Corporate Communications and Patient Advocacy
    Lexicon Pharmaceuticals
    (281) 863-3421

    Primary Logo

    View Full Article Hide Full Article
  32. THE WOODLANDS, Texas, Jan. 06, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that Lonnel Coats, President and Chief Executive Officer, will present at the following conference:

    • 38th Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2020 at 7:30 a.m. PST in San Francisco, CA.

    A live audio webcast for this conference will be available in the "Events" section of the Lexicon website at www.lexpharma.com/. An archived version of the webcast will be available on the website for two weeks.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated biopharmaceutical company with a mission of pioneering medicines that transform patients' lives. Through its Genome5000™ program, Lexicon scientists…

    THE WOODLANDS, Texas, Jan. 06, 2020 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that Lonnel Coats, President and Chief Executive Officer, will present at the following conference:

    • 38th Annual J.P. Morgan Healthcare Conference on Thursday, January 16, 2020 at 7:30 a.m. PST in San Francisco, CA.

    A live audio webcast for this conference will be available in the "Events" section of the Lexicon website at www.lexpharma.com/. An archived version of the webcast will be available on the website for two weeks.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including 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 those relating to Lexicon's ability to meet its capital requirements, successfully conduct preclinical and clinical development of its drug candidates, obtain necessary regulatory approvals, 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, that 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, 2018, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.
    Head of Investor Relations and Corporate Strategy
    Lexicon Pharmaceuticals
    (281) 863-3383

    For Media Inquiries:

    Chas Schultz
    Executive Director, Corporate Communications and Patient Advocacy
    Lexicon Pharmaceuticals
    (281) 863-3421

    Primary Logo

    View Full Article Hide Full Article
  33. THE WOODLANDS, Texas, Dec. 20, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today announced topline data from the Phase 3 SOTA-EMPA study for sotagliflozin (Zynquista™) in type 2 diabetes. The topline results are as follows:

    • Sotagliflozin 400 mg achieved the primary endpoint of superiority on A1C reduction versus placebo at Week 26 in patients with type 2 diabetes who have inadequate glycemic control on a dipeptidyl peptidase 4 inhibitor (DPP4i) with or without metformin.
    • Sotagliflozin 400 mg also achieved the key secondary endpoint of noninferiority versus empagliflozin on A1C reduction from baseline at Week 26.
    • Sotagliflozin was generally well tolerated with safety results comparable to previously reported results…

    THE WOODLANDS, Texas, Dec. 20, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today announced topline data from the Phase 3 SOTA-EMPA study for sotagliflozin (Zynquista™) in type 2 diabetes. The topline results are as follows:

    • Sotagliflozin 400 mg achieved the primary endpoint of superiority on A1C reduction versus placebo at Week 26 in patients with type 2 diabetes who have inadequate glycemic control on a dipeptidyl peptidase 4 inhibitor (DPP4i) with or without metformin.
    • Sotagliflozin 400 mg also achieved the key secondary endpoint of noninferiority versus empagliflozin on A1C reduction from baseline at Week 26.
    • Sotagliflozin was generally well tolerated with safety results comparable to previously reported results.

    The full results of SOTA-EMPA, the fourth of nine core Phase 3 studies in the sotagliflozin type 2 diabetes program, will be presented at future medical conferences.

    "We are pleased that today's results demonstrate sotagliflozin achieved a clinical profile comparable to the efficacy of empagliflozin and a safety profile consistent with previously reported results," said Pablo Lapuerta, M.D., executive vice president and chief medical officer at Lexicon. "We look forward to the release of topline data from the remainder of the core Phase 3 sotagliflozin studies in type 2 diabetes in early 2020."

    About SOTA-EMPA

    SOTA-EMPA is a Phase 3, multicenter, 2:2:1 randomized, double-blind, placebo- and active-controlled, parallel-group study evaluating the efficacy and safety of sotagliflozin 400 mg compared to empagliflozin 25 mg and placebo in approximately 700 subjects with type 2 diabetes who have inadequate glycemic control on DPP4i with or without metformin.

    The primary endpoint of the study is superiority of sotagliflozin 400 mg versus placebo on A1C reduction at Week 26 in patients with type 2 diabetes who have inadequate glycemic control on a DPP4i with or without metformin and a key secondary endpoint at Week 26 is noninferiority of sotagliflozin 400 mg versus empagliflozin on A1C reduction from baseline.

    About Zynquista (sotagliflozin)

    Discovered using Lexicon's unique approach to gene science, Zynquista is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Zynquista is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy. Outside of such approval, Zynquista is investigational and has not been approved by any other regulatory authority for type 1 or type 2 diabetes.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements" relating to Lexicon's clinical development of sotagliflozin and the potential therapeutic and commercial potential of sotagliflozin. 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 XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, sotagliflozin, LX9211 and its other potential 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 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, 2018, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.
    Head of Investor Relations and Corporate Strategy
    Lexicon Pharmaceuticals
    (281) 863-3383

    For Media Inquiries:

    Chas Schultz
    Executive Director, Corporate Communications and Patient Advocacy
    Lexicon Pharmaceuticals
    (281) 863-3421

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  34. THE WOODLANDS, Texas, Dec. 05, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today announced positive topline data from the Phase 1 multiple ascending dose study of LX9211, a potent oral small molecule inhibitor of adaptor associated kinase 1 (AAK1), in development for the treatment of neuropathic pain.

    "We are pleased that the initial clinical data for LX9211 in the multiple ascending dose study supports continued advancement of the drug," said Praveen Tyle, Ph.D., executive vice president of research and development at Lexicon. "LX9211 was well tolerated with dose proportional pharmacokinetics, similar to what was seen in the single ascending dose study. We expect to initiate a proof-of-concept study for LX9211 early…

    THE WOODLANDS, Texas, Dec. 05, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today announced positive topline data from the Phase 1 multiple ascending dose study of LX9211, a potent oral small molecule inhibitor of adaptor associated kinase 1 (AAK1), in development for the treatment of neuropathic pain.

    "We are pleased that the initial clinical data for LX9211 in the multiple ascending dose study supports continued advancement of the drug," said Praveen Tyle, Ph.D., executive vice president of research and development at Lexicon. "LX9211 was well tolerated with dose proportional pharmacokinetics, similar to what was seen in the single ascending dose study. We expect to initiate a proof-of-concept study for LX9211 early next year."

    The randomized, double-blind, placebo-controlled, multiple ascending dose Phase 1 study was performed to evaluate the safety, tolerability and pharmacokinetics of orally administered LX9211 in healthy volunteers. The study was comprised of five cohorts over a wide loading dose range of 25 mg to 200 mg followed by a maintenance dose for 14 days. LX9211 demonstrated a favorable safety and pharmacokinetics profile supportive of once-daily dosing and exhibited dose proportional pharmacokinetics. The most common adverse events were headache and dizziness, and there were no drug-related serious adverse events.

    About LX9211

    LX9211 is a potent, orally delivered, selective small molecule inhibitor of AAK1, a target discovered and extensively characterized in an alliance with Bristol Myers Squibb. Preclinical data demonstrated central nervous system penetration and reduction in pain behavior in models of neuropathic pain. Lexicon has exclusive research, development and commercialization rights to LX9211 and additional compounds acting through AAK1.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's clinical development of and regulatory filings for LX9211 and the potential therapeutic and commercial potential of LX9211. 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 the risk that clinical studies of LX9211 may be halted, delayed or otherwise not demonstrate safety or efficacy, the risk that the FDA and other regulatory authorities may not grant regulatory approval of LX9211 in accordance with Lexicon's currently anticipated timelines or at all, and the risk that such regulatory approvals, if granted, may have significant limitations on the approved use of LX9211. As a result, LX9211 may never be successfully commercialized. Other risks include Lexicon's ability to meet its capital requirements, successfully commercialize XERMELO (telotristat ethyl), successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, sotagliflozin and its other potential 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 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, 2018, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.
    Head of Investor Relations and Corporate Strategy
    Lexicon Pharmaceuticals
    (281) 863-3383

    For Media Inquiries:

    Chas Schultz
    Executive Director, Corporate Communications and Patient Advocacy
    Lexicon Pharmaceuticals
    (281) 863-3421

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  35. THE WOODLANDS, Texas, Dec. 03, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today the completion of a safety review of the initial run-in cohort of the Telotristat Ethyl for Advanced Biliary Tract Cancer, or TELE-ABC, study, which is a Phase 2 clinical study of telotristat ethyl in patients with biliary tract cancer. Telotristat ethyl is a novel, oral tryptophan hydroxylase (TPH) inhibitor approved as XERMELO® for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy alone.

    Safety analysis from the first six patients who completed at least a 21-day cycle of treatment with telotristat ethyl in combination with cisplatin…

    THE WOODLANDS, Texas, Dec. 03, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today the completion of a safety review of the initial run-in cohort of the Telotristat Ethyl for Advanced Biliary Tract Cancer, or TELE-ABC, study, which is a Phase 2 clinical study of telotristat ethyl in patients with biliary tract cancer. Telotristat ethyl is a novel, oral tryptophan hydroxylase (TPH) inhibitor approved as XERMELO® for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy alone.

    Safety analysis from the first six patients who completed at least a 21-day cycle of treatment with telotristat ethyl in combination with cisplatin and gemcitabine supports the continuation of enrollment with no adjustment in the telotristat ethyl 500 mg three times daily dosing. To date, the first two patients enrolled have completed over six months of treatment.

    "We are pleased that the safety review of the first dose cohort supports continuation of the study in patients with biliary tract cancer," said Pablo Lapuerta, MD, executive vice president and chief medical officer of Lexicon. "We believe telotristat ethyl's mechanism of action has potential utility outside of carcinoid syndrome diarrhea. Inhibiting serotonin may help control tumor growth, and we look forward to obtaining topline data on progression-free survival for the first 20 biliary tract cancer patients next year."

    About the TELE-ABC Study

    The TELE-ABC study is a multicenter, open-label, two-stage Phase 2 study evaluating the safety and efficacy of telotristat ethyl in combination with standard of care, first-line chemotherapy (cisplatin plus gemcitabine) in approximately 53 patients with unresectable, locally advanced, recurrent or metastatic biliary tract cancer. The primary efficacy endpoint under evaluation is progression-free survival (PFS) rate at six months. Secondary endpoints include overall survival (OS), OS rate at six and 12 months, and PFS rate at 12 months.

    Subject to completion of patient enrollment, Lexicon expects to report topline results on 6-month progression-free survival data from the first 20 patients of the TELE-ABC study in 2020.

    About XERMELO (Telotristat Ethyl)

    Discovered using Lexicon's unique approach to gene science, XERMELO is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with mNETs and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

    Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. Lexicon is commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.

    XERMELO (Telotristat Ethyl) Important Safety Information

    • Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
    • Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
    • Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO. 

    For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business, including the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO (telotristat ethyl), sotagliflozin and LX9211. 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 XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, sotagliflozin and LX9211 and its other potential 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 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, 2018, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.
    Head of Investor Relations and Corporate Strategy
    Lexicon Pharmaceuticals
    (281) 863-3383

    For Media Inquiries:

    Chas Schultz
    Executive Director, Corporate Communications and Patient Advocacy
    Lexicon Pharmaceuticals
    (281) 863-3421

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  36. THE WOODLANDS, Texas, Dec. 02, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today announced that the Office of New Drugs of the U.S. Food and Drug Administration (FDA) has reiterated the FDA's prior position and denied Lexicon's appeal of the Complete Response Letter in relation to the New Drug Application for sotagliflozin (ZynquistaTM) in type 1 diabetes. Lexicon intends to appeal the decision to the Center for Drug Evaluation and Research, or CDER.

    Conference Call Information

    Lexicon management will hold a live conference call today, December 2, 2019, at 8:00 am EST / 7:00 am CST to discuss today's announcement. The dial-in number for the conference call is 888-645-5785 (U.S./Canada) or 970-300-1531 (international…

    THE WOODLANDS, Texas, Dec. 02, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today announced that the Office of New Drugs of the U.S. Food and Drug Administration (FDA) has reiterated the FDA's prior position and denied Lexicon's appeal of the Complete Response Letter in relation to the New Drug Application for sotagliflozin (ZynquistaTM) in type 1 diabetes. Lexicon intends to appeal the decision to the Center for Drug Evaluation and Research, or CDER.

    Conference Call Information

    Lexicon management will hold a live conference call today, December 2, 2019, at 8:00 am EST / 7:00 am CST to discuss today's announcement. The dial-in number for the conference call is 888-645-5785 (U.S./Canada) or 970-300-1531 (international). The conference ID for all callers is 1857906. The replay may be accessed by visiting Lexicon's website at www.lexpharma.com/investors and will be available on the website for 14 days.

    About Zynquista (sotagliflozin)

    Discovered using Lexicon's unique approach to gene science, Zynquista is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Zynquista is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy. Outside of such approval, Zynquista is investigational and has not been approved by any other regulatory authority for type 1 or type 2 diabetes.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business and the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO® (telotristat ethyl), Zynquista (sotagliflozin) and LX9211. 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 XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, sotagliflozin, LX9211 and its other potential 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 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, 2018, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.
    Head of Investor Relations and Corporate Strategy
    Lexicon Pharmaceuticals
    (281) 863-3383

    For Media Inquiries:

    Chas Schultz
    Executive Director, Corporate Communications and Patient Advocacy
    Lexicon Pharmaceuticals
    (281) 863-3421
     

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  37. THE WOODLANDS, Texas, Nov. 26, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that Jeffrey L. Wade, J.D., Executive Vice President, Corporate and Administrative Affairs and Chief Financial Officer, will present at the following conference:

    • Evercore ISI 2nd Annual HealthCONx Conference on Tuesday, December 3, 2019 at 2:00 p.m. EST in Boston, MA.

    A live audio webcast for this conference will be available in the "Events" section of the Lexicon website at www.lexpharma.com/. An archived version of the webcast will be available on the website for two weeks.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated biopharmaceutical company with a mission of pioneering medicines that transform patients' lives…

    THE WOODLANDS, Texas, Nov. 26, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that Jeffrey L. Wade, J.D., Executive Vice President, Corporate and Administrative Affairs and Chief Financial Officer, will present at the following conference:

    • Evercore ISI 2nd Annual HealthCONx Conference on Tuesday, December 3, 2019 at 2:00 p.m. EST in Boston, MA.

    A live audio webcast for this conference will be available in the "Events" section of the Lexicon website at www.lexpharma.com/. An archived version of the webcast will be available on the website for two weeks.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including 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 those relating to Lexicon's ability to meet its capital requirements, successfully conduct preclinical and clinical development of its drug candidates, obtain necessary regulatory approvals, 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, that 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, 2018, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.
    Head of Investor Relations and Corporate Strategy
    Lexicon Pharmaceuticals
    (281) 863-3383

    For Media Inquiries:

    Chas Schultz
    Executive Director, Corporate Communications and Patient Advocacy
    Lexicon Pharmaceuticals
    (281) 863-3421

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  38. THE WOODLANDS, Texas, Nov. 14, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that Lonnel Coats, President and Chief Executive Officer, will present at the following conference:

    • Stifel 2019 Healthcare Conference on Tuesday, November 19, 2019 at 3:35 p.m. EST in New York, NY.

    A live audio webcast for this conference will be available in the "Events" section of the Lexicon website at www.lexpharma.com/. An archived version of the webcast will be available on the website for two weeks.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated biopharmaceutical company with a mission of pioneering medicines that transform patients' lives. Through its Genome5000™ program, Lexicon scientists studied the role…

    THE WOODLANDS, Texas, Nov. 14, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that Lonnel Coats, President and Chief Executive Officer, will present at the following conference:

    • Stifel 2019 Healthcare Conference on Tuesday, November 19, 2019 at 3:35 p.m. EST in New York, NY.

    A live audio webcast for this conference will be available in the "Events" section of the Lexicon website at www.lexpharma.com/. An archived version of the webcast will be available on the website for two weeks.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including 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 those relating to Lexicon's ability to meet its capital requirements, successfully conduct preclinical and clinical development of its drug candidates, obtain necessary regulatory approvals, 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, that 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, 2018, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.
    Head of Investor Relations and Corporate Strategy
    Lexicon Pharmaceuticals
    (281) 863-3383

    For Media Inquiries:

    Chas Schultz
    Executive Director, Corporate Communications and Patient Advocacy
    Lexicon Pharmaceuticals
    (281) 863-3421

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  39. THE WOODLANDS, Texas, Nov. 07, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today reported financial results and provided a business update for the three months ended September 30, 2019.

    "We continue to make good progress on our XERMELO business, with XERMELO net sales growing more than 30% in the third quarter of 2019 versus the same period in 2018," said Lonnel Coats, Lexicon's president and chief executive officer. "We now have full rights for Zynquista. We expect to complete the core Phase 3 studies in type 2 diabetes in the near term and anticipate being in a position to file for regulatory approval for that indication in the U.S. and in Europe in the first half of 2020. We continue to have productive dialogue…

    THE WOODLANDS, Texas, Nov. 07, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today reported financial results and provided a business update for the three months ended September 30, 2019.

    "We continue to make good progress on our XERMELO business, with XERMELO net sales growing more than 30% in the third quarter of 2019 versus the same period in 2018," said Lonnel Coats, Lexicon's president and chief executive officer. "We now have full rights for Zynquista. We expect to complete the core Phase 3 studies in type 2 diabetes in the near term and anticipate being in a position to file for regulatory approval for that indication in the U.S. and in Europe in the first half of 2020. We continue to have productive dialogue with the FDA on a path forward for Zynquista in type 1 diabetes in the U.S."

    Third Quarter Product and Pipeline Highlights

    XERMELO® (telotristat ethyl)

    • XERMELO U.S. net sales were $8.4 million in the third quarter of 2019.
    • The Telotristat Ethyl for Advanced Biliary Tract Cancer, or TELE-ABC, study, a Phase 2a clinical study of telotristat ethyl in patients with biliary tract cancer, continues to enroll patients.

    Zynquista™ (sotagliflozin)

    • In September, Lexicon and Sanofi terminated their alliance for the development and commercialization of sotagliflozin. In connection with the termination, Lexicon regained all rights to sotagliflozin and assumed full responsibility for the worldwide development and commercialization of sotagliflozin in both type 1 and type 2 diabetes. Under the terms of the settlement, Sanofi will pay Lexicon $260 million, of which $208 million was paid in September and the remainder is payable within twelve months. Sanofi continues to coordinate with Lexicon in the transition of responsibility for ongoing clinical studies and other activities.
       
    • Clinical data for sotagliflozin were highlighted in two oral presentations at the European Association for the Study of Diabetes (EASD) 55th annual meeting (September 16-20; Barcelona, Spain), demonstrating the effect of sotagliflozin on body weight and composition in adults with type 1 diabetes. In addition, five posters were presented, detailing the reductions in glucose variability and risk for hyperglycemia in adults with type 1 diabetes treated with sotagliflozin alone, improved treatment satisfaction in patients with type 1 diabetes treated with sotagliflozin and insulin versus insulin alone, lower rates of clinically relevant hypoglycemic events at any A1C level at 52 weeks in adults with type 1 diabetes, the positive impact of sotagliflozin on renal function, albuminuria and blood pressure in adults with type 1 diabetes and the reduction in markers of arterial stiffness in patients with type 1 diabetes.
       
    • In September, a post-hoc analysis of hypoglycemia as a function of A1C in patients with type 1 diabetes receiving sotagliflozin or placebo in combination with optimized insulin therapy was published in Diabetes Technology and Therapeutics. The pooled analysis from inTandem1 and inTandem2 trials showed that at 52 weeks, level 1 and 2 hypoglycemia events were 22% to 30% less frequent with sotagliflozin added to optimized insulin therapy versus placebo in adults with type 1 diabetes at any A1C level, with greater differences at lower A1C values.
       
    • In August, 52-week cardiorenal results from a pooled analysis from the inTandem1 and inTandem2 studies of sotagliflozin in adults with type 1 diabetes were published in Diabetes Care. Sotagliflozin demonstrated changes in clinical biomarkers such as estimated glomerular filtration rate (eGFR), hematocrit, serum albumin, uric acid, systolic blood pressure and urinary albumin-to-creatinine ratio (UACR) that suggest sotagliflozin may reduce cardiovascular risk and progression of chronic kidney disease. Sotagliflozin was associated with short- and long-term renal hemodynamic changes. After cessation of 52 weeks of therapy, eGFR was comparable to baseline and significantly higher than placebo in sotagliflozin-treated patients.
       
    • In July, Lexicon announced the preliminary topline results received from Sanofi from SOTA-MET, SOTA-CKD3 and SOTA-CKD4, the first three of a total of nine clinical trials included in the core Phase 3 development program for sotagliflozin in type 2 diabetes.

    Third Quarter 2019 Financial Highlights

    Revenues: Revenues for the three months ended September 30, 2019 increased to $294.4 million from $7.0 million for the corresponding period in 2018, primarily due to an increase of collaborative revenues of $260 million from the termination of the alliance with Sanofi and recognition of the remaining amount of $23.5 million allocated to performance obligations from the initial agreement with Sanofi and an increase in net product revenue. Net product revenues for the three months ended September 30, 2019 consisted of $8.4 million from net sales of XERMELO in the U.S., which were up 33% from the prior year quarter.

    Cost of Sales: Cost of sales related to sales of XERMELO for each of the three months ended September 30, 2019 and 2018 was $0.6 million.

    Research and Development (R&D) Expenses: Research and development expenses for the three months ended September 30, 2019 increased to $26.7 million from $13.8 million for the corresponding period in 2018, primarily due to an increase in external clinical development costs related to sotagliflozin subsequent to the termination of the alliance with Sanofi, in which Lexicon regained the rights and responsibilities for development and commercialization for sotagliflozin.

    Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the three months ended September 30, 2019 decreased to $13.9 million from $15.6 million for the corresponding period in 2018, primarily due to decreased marketing costs.

    Impairment Loss on Intangible Asset: An impairment loss for the three months ended September 30, 2019 of $28.6 million was recognized to an indefinite lived intangible asset associated with Lexicon's 2010 acquisition of Symphony Icon, due to the decision to terminate research and development activities related to a program for irritable bowel syndrome that was among the assets acquired.

    Income Tax Benefit:  An income tax benefit of $6.0 million for the three months ended September 30, 2019 was recognized in connection with the impairment loss on the indefinite lived intangible asset, which resulted in a decrease to the deferred tax liability and created an income tax benefit.

    Net Income (Loss): Net income for the three months ended September 30, 2019 was $226.1 million, or $1.95 per diluted share, as compared to a net loss of $27.4 million, or a loss of $0.26 per share, in the corresponding period in 2018. For the three months ended September 30, 2019 and 2018, net income included non-cash, stock-based compensation expense of $3.6 million and $2.9 million, respectively.

    Cash and Investments: As of September 30, 2019, Lexicon had $296.3 million in cash and investments, as compared to $160.1 million as of December 31, 2018. The cash position as of September 30, 2019 includes proceeds of $208 million in connection with the termination of the alliance with Sanofi.

    Anticipated Near-Term Milestones

    • Q4 2019 – Topline Phase 1 data for LX9211
    • Q4 2019 / early 2020 – Topline results from core Phase 3 studies for sotagliflozin in type 2 diabetes
    • Q4 2019 – Completion of patient enrollment of the initial safety cohort in the Phase 2 study of telotristat ethyl in biliary tract cancer

    Conference Call and Webcast Information

    Lexicon management will hold a live conference call and webcast today at 8:00 am EST / 7:00 am CST to review its financial and operating results and to provide a general business update. The dial-in number for the conference call is 888-645-5785 (U.S./Canada) or 970-300-1531 (international). The conference ID for all callers is 8189178. The live webcast and replay may be accessed by visiting Lexicon's website at www.lexpharma.com/investors. An archived version of the webcast will be available on the website for 14 days.

    About XERMELO (telotristat ethyl)

    Discovered using Lexicon's unique approach to gene science, XERMELO (telotristat ethyl) is the first and only approved oral therapy for carcinoid syndrome diarrhea. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with mNETs and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

    Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. We are commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.

    XERMELO (telotristat ethyl) Important Safety Information

    • Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
    • Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
    • Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO. 

    For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

    About Zynquista (sotagliflozin)

    Discovered using Lexicon's unique approach to gene science, Zynquista is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Zynquista is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy. Outside of such approval, Zynquista is investigational and has not been approved by any other regulatory authority for type 1 or type 2 diabetes.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business, including the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO (telotristat ethyl), Zynquista (sotagliflozin), and LX9211. 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 XERMELO, successfully complete the transition from Sanofi of responsibility for ongoing clinical studies and other activities relating to sotagliflozin, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, sotagliflozin, LX9211 and its other potential 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 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, 2018, 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)   2019   2018   2019   2018    
        (Unaudited)   (Unaudited)    
    Revenues:                    
    Net product revenue   $ 8,351     $ 6,286     $ 23,763     $ 19,062      
    Collaborative agreements     285,910       556       289,209       26,792      
    Royalties and other revenue     187       124       374       284      
    Total revenues     294,448       6,966       313,346       46,138      
    Operating expenses:                    
    Cost of sales (including finite-lived intangible asset amortization)     577       551       2,457       1,922      
    Research and development, including stock-based compensation of $1,698, $1,472, $5,369 and $4,522, respectively     26,659       13,763       51,318       87,936      
    Selling, general and administrative, including stock-based                    
      compensation of $1,864, $1,405, $5,370 and $4,327, respectively     13,898       15,579       42,271       47,191      
    Impairment loss on intangible asset     28,638       -       28,638       -      
    Total operating expenses     69,772       29,893       124,684       137,049      
    Income (loss) from operations     224,676       (22,927 )     188,662       (90,911 )    
    Interest expense     (5,204 )     (5,252 )     (15,485 )     (15,552 )    
    Interest and other income, net     600       783       2,080       2,698      
    Net income (loss) before income taxes     220,072       (27,396 )     175,257       (103,765 )    
    Income tax benefit     6,014       -       6,014       -      
    Net income (loss)   $ 226,086     $ (27,396 )   $ 181,271     $ (103,765 )    
                         
    Net income (loss) per common share, basic   $ 2.13     $ (0.26 )   $ 1.71     $ (0.98 )    
    Net income (loss) per common share, diluted   $ 1.95     $ (0.26 )   $ 1.59     $ (0.98 )    
                         
    Shares used in computing net income (loss) per                    
    common share, basic     106,272       105,881       106,200       105,800      
    Shares used in computing net income (loss) per                    
    common share, diluted     116,640       105,881       116,742       105,800      
                         
                         
                         
                As of   As of    
    Consolidated Balance Sheet Data           September 30, 2019  December 31, 2018  
    (In thousands)           (Unaudited)        
      Cash and investments       $ 296,304     $ 160,052      
      Property and equipment, net         14,540       15,865      
      Goodwill         44,543       44,543      
      Other intangible assets         20,157       50,119      
      Total assets         444,588       284,136      
      Deferred revenue         1,117       27,046      
      Current and long-term debt         245,126       245,002      
      Accumulated deficit         (1,290,306 )     (1,471,577 )    
      Total stockholders' equity (deficit)     164,712       (26,405 )    
                         


    For Investor Inquiries
    :

    Kimberly Lee, D.O.
    Head of Investor Relations and Corporate Strategy
    Lexicon Pharmaceuticals
    (281) 863-3383

    For Media Inquiries:

    Chas Schultz
    Executive Director, Corporate Communications and Patient Advocacy
    Lexicon Pharmaceuticals
    (281) 863-3421

    Primary Logo

    View Full Article Hide Full Article
  40. THE WOODLANDS, Texas, Oct. 31, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), will release its third quarter 2019 financial results on Thursday, November 7, 2019 before market opens. Management will conduct a conference call and live webcast at 8:00 a.m. EST (7:00 a.m. CST) that day to discuss the financial results and to provide a business update.

    Dial-in Information
    U.S. Dial-in Number:  (888) 645-5785
    International Dial-in Number:  (970) 300-1531
    Conference ID:  8189178

    Replay Information
    U.S. Dial-in Number:  (855) 859-2056
    Replay International Dial-in Number:  (404) 537-3406
    Conference ID:  8189178

    The dial-in replay will be available for 7 days following the call. An audio webcast will be available online in the investor…

    THE WOODLANDS, Texas, Oct. 31, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), will release its third quarter 2019 financial results on Thursday, November 7, 2019 before market opens. Management will conduct a conference call and live webcast at 8:00 a.m. EST (7:00 a.m. CST) that day to discuss the financial results and to provide a business update.

    Dial-in Information
    U.S. Dial-in Number:  (888) 645-5785
    International Dial-in Number:  (970) 300-1531
    Conference ID:  8189178

    Replay Information
    U.S. Dial-in Number:  (855) 859-2056
    Replay International Dial-in Number:  (404) 537-3406
    Conference ID:  8189178

    The dial-in replay will be available for 7 days following the call. An audio webcast will be available online in the investor relations section of the company website at www.lexpharma.com/investors, with a webcast replay accessible for 14 days after the call.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business, including the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO (telotristat ethyl), Zynquista (sotagliflozin), and LX9211. 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 XERMELO, successfully complete the transition from Sanofi of responsibility for ongoing clinical studies and other activities relating to sotagliflozin, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, sotagliflozin, LX9211 and its other potential 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 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, 2018, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.
    Head of Investor Relations and Corporate Strategy
    Lexicon Pharmaceuticals
    (281) 863-3383

    For Media Inquiries:

    Chas Schultz
    Executive Director, Corporate Communications and Patient Advocacy
    Lexicon Pharmaceuticals
    (281) 863-3421

    Primary Logo

    View Full Article Hide Full Article
  41. THE WOODLANDS, Texas, Oct. 02, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today that data from five posters highlighting XERMELO® (telotristat ethyl) will be presented at the upcoming North American Neuroendocrine Tumor Society Annual Multidisciplinary NET Medical Symposium (NANETS; October 3-5, Boston, MA).

    Additional information on poster details can be found below and can be accessed at https://nanets.net/symposium.

    Poster Details

    • Benson, A. et al. Real-World Effectiveness of Telotristat Ethyl among Patients with Mild Baseline Diarrhea (Abstract ID: 78)
    • DiGialleonardo, V. et al., Improvement in Carcinoid Syndrome-Related Symptoms with Telotristat Ethyl in Patients with 2 or Less Bowel Movements Per Day…

    THE WOODLANDS, Texas, Oct. 02, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), announced today that data from five posters highlighting XERMELO® (telotristat ethyl) will be presented at the upcoming North American Neuroendocrine Tumor Society Annual Multidisciplinary NET Medical Symposium (NANETS; October 3-5, Boston, MA).

    Additional information on poster details can be found below and can be accessed at https://nanets.net/symposium.

    Poster Details

    • Benson, A. et al. Real-World Effectiveness of Telotristat Ethyl among Patients with Mild Baseline Diarrhea (Abstract ID: 78)
    • DiGialleonardo, V. et al., Improvement in Carcinoid Syndrome-Related Symptoms with Telotristat Ethyl in Patients with 2 or Less Bowel Movements Per Day (Abstract ID: 145)
    • Hörsch D et al., The TELEPATH Phase 3 Study: An Analysis of Long-term Treatment with Telotristat Ethyl in Patients with Carcinoid Syndrome Symptoms (Abstract ID: 33)
    • Price, M. et al. XERMELO Patient Registry:  Improvements in Clinical Outcomes, Patient Satisfaction, and Weight with Telotristat Ethyl in The Real-World (Abstract ID: 77)
    • Wang, X., et al., Effect of Telotristat Ethyl on Cardiac Valve Degeneration (Abstract ID: 80)                   

    About XERMELO (telotristat ethyl)

    Discovered using Lexicon's unique approach to gene science, XERMELO (telotristat ethyl) is the first and only approved oral therapy for carcinoid syndrome diarrhea in combination with somatostatin analog (SSA) therapy in adults inadequately controlled by SSAs. XERMELO targets tryptophan hydroxylase, an enzyme that mediates the excess serotonin production within metastatic neuroendocrine tumor (mNET) cells. XERMELO is approved in the United States, the European Union and certain additional countries for the treatment of carcinoid syndrome diarrhea in combination with SSA therapy in adults inadequately controlled by SSA therapy. Carcinoid syndrome is a rare condition that occurs in patients living with metastatic NETs (mNETs) and is characterized by frequent and debilitating diarrhea. XERMELO targets the overproduction of serotonin inside mNET cells, providing an additional treatment option for patients suffering from carcinoid syndrome diarrhea.

    Lexicon has granted Ipsen an exclusive royalty-bearing right and license to commercialize XERMELO outside of the United States and Japan. We are commercializing XERMELO in the United States and Ipsen is commercializing XERMELO in multiple countries, including the United Kingdom and Germany.

    XERMELO (telotristat ethyl) Important Safety Information

    • Warnings and Precautions: XERMELO may cause constipation, which can be serious. Monitor for signs and symptoms of constipation and/or severe, persistent, or worsening abdominal pain in patients taking XERMELO. Discontinue XERMELO if severe constipation or severe, persistent, or worsening abdominal pain develops.
    • Adverse Reactions: The most common adverse reactions (≥5%) include nausea, headache, increased gamma-glutamyl-transferase, depression, flatulence, decreased appetite, peripheral edema, and pyrexia.
    • Drug Interactions: If necessary, consider increasing the dose of concomitant CYP3A4 substrates, as XERMELO may decrease their systemic exposure. If combination treatment with XERMELO and short-acting octreotide is needed, administer short-acting octreotide at least 30 minutes after administering XERMELO.

    For more information about XERMELO, see Full Prescribing Information at www.xermelo.com.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business, including the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of XERMELO (telotristat ethyl), sotagliflozin, LX2761 and LX9211. 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 XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, sotagliflozin, LX2761, LX9211 and its other potential 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 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, 2018, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.
    Head of Investor Relations and Corporate Strategy
    Lexicon Pharmaceuticals
    (281) 863-3383

    For Media Inquiries:

    Chas Schultz
    Executive Director, Corporate Communications and Patient Advocacy
    Lexicon Pharmaceuticals
    (281) 863-3421

    Primary Logo

    View Full Article Hide Full Article
  42. THE WOODLANDS, Texas, Sept. 10, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today announced the termination of its alliance with Sanofi for the development and commercialization of ZynquistaTM (sotagliflozin) and the settlement of its related disputes with Sanofi, each effective September 9, 2019. In connection with the termination, Lexicon will regain all rights to Zynquista and assume full responsibility for the worldwide development and commercialization of Zynquista in both type 1 and type 2 diabetes. Under the terms of the settlement, Sanofi will pay Lexicon $260 million, of which $208 million is payable upfront and the remainder is payable within twelve months, and coordinate with Lexicon in the transition of…

    THE WOODLANDS, Texas, Sept. 10, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today announced the termination of its alliance with Sanofi for the development and commercialization of ZynquistaTM (sotagliflozin) and the settlement of its related disputes with Sanofi, each effective September 9, 2019. In connection with the termination, Lexicon will regain all rights to Zynquista and assume full responsibility for the worldwide development and commercialization of Zynquista in both type 1 and type 2 diabetes. Under the terms of the settlement, Sanofi will pay Lexicon $260 million, of which $208 million is payable upfront and the remainder is payable within twelve months, and coordinate with Lexicon in the transition of responsibility for ongoing clinical studies and other activities.

    "Our four-year alliance with Sanofi has been a productive one, with Zynquista receiving marketing approval in Europe in type 1 diabetes and advancing into late-stage studies in type 2 diabetes," said Lonnel Coats, president and chief executive officer of Lexicon. "Regaining worldwide rights allows us to advance our efforts to realize the full value of the Zynquista program as we prepare for regulatory filings in the U.S. and in Europe in type 2 diabetes, with data coming over the next few months from the remainder of the core Phase 3 studies and over the longer term from two outcomes studies with potential for demonstrating cardiovascular and renal benefits. We believe that this potential, along with a European approval in type 1 diabetes, offer an attractive opportunity for potential collaborators as we work to maximize the global potential for Zynquista and to achieve greater operational flexibility."

    Conference Call and Webcast Information

    Lexicon management will hold a live conference call and webcast today at 5:00 pm EDT / 4:00 pm CDT to discuss today's announcement. The dial-in number for the conference call is 888-645-5785 (U.S./Canada) or 970-300-1531 (international). The conference ID for all callers is 7376526. The live webcast and replay may be accessed by visiting Lexicon's website at www.lexpharma.com/investors. An archived version of the webcast will be available on the website for 14 days.

    About Zynquista (sotagliflozin)

    Discovered using Lexicon's unique approach to gene science, Zynquista is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Zynquista is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy. Outside of such approval, Zynquista is investigational and has not been approved by any other regulatory authority for type 1 or type 2 diabetes.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business, the commercialization of XERMELO (telotristat ethyl) and Zynquista (sotagliflozin), and the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of telotristat ethyl, sotagliflozin, LX2761 and LX9211. 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 XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, sotagliflozin, LX2761, LX9211 and its other potential 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 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, 2018, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.
    Head of Investor Relations and Corporate Strategy
    Lexicon Pharmaceuticals
    (281) 863-3383

    For Media Inquiries:

    Chas Schultz
    Executive Director, Corporate Communications and Patient Advocacy
    Lexicon Pharmaceuticals
    (281) 863-3421

    Primary Logo

    View Full Article Hide Full Article
  43. THE WOODLANDS, Texas, Sept. 10, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today announced that clinical data for ZynquistaTM (sotagliflozin) will be presented at the upcoming European Association for the Study of Diabetes (EASD) 55th annual meeting (September 16-20; Barcelona, Spain). The accepted abstracts, including two oral presentations, reflect Lexicon's efforts to address the unmet need for new options for the management of type 1 diabetes.

    Oral Presentations (all times local)

    • Tuesday, September 17, 10:15 am-11:45 am; Session OP 01: "SGLT2 Inhibitors: Glucose and Beyond"; Joslin Hall
       
      • "Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, in Overweight/Obese Patients with Type 1 Diabetes: Addressing Unmet Needs…

    THE WOODLANDS, Texas, Sept. 10, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX), today announced that clinical data for ZynquistaTM (sotagliflozin) will be presented at the upcoming European Association for the Study of Diabetes (EASD) 55th annual meeting (September 16-20; Barcelona, Spain). The accepted abstracts, including two oral presentations, reflect Lexicon's efforts to address the unmet need for new options for the management of type 1 diabetes.

    Oral Presentations (all times local)

    • Tuesday, September 17, 10:15 am-11:45 am; Session OP 01: "SGLT2 Inhibitors: Glucose and Beyond"; Joslin Hall
       
      • "Sotagliflozin, a Dual SGLT1 and SGLT2 Inhibitor, in Overweight/Obese Patients with Type 1 Diabetes: Addressing Unmet Needs as Adjunct Therapy to Insulin" (Abstract #2)
      • "Effect of Sotagliflozin on Body Weight and Composition in Adults with Type 1 Diabetes" (Abstract #3)

    Posters

    • Wednesday, September 18, 12:00 pm-1:00 pm; Session PS 051: "SGLT2 Inhibitors in Type 1 Diabetes: Benefits and Harms"; Poster Hall
       
      • "Sotagliflozin Reduces Glucose Variability and Risk for Hyperglycemia in Adults with Type 1 Diabetes" (Abstract #717)
      • "Improved Treatment Satisfaction in Patients with Type 1 Diabetes Treated with Sotagliflozin Plus Insulin vs. Insulin Alone" (Abstract #724)
         
    • Wednesday, September 18, 12:00 pm-1:00 pm; Session PS 065: "Clinical Aspects of Hypoglycemia"; Poster Hall
       
      • "Sotagliflozin Leads to Lower Rates of Clinically Relevant Hypoglycemic Events at Any HbA1c Level at Week 52 in Adults with Type 1 Diabetes" (Abstract #849)
         
    • Wednesday, September 18, 1:15 pm-2:15 pm; Session PS 082: "Promising Therapeutic Options for Diabetic Kidney Disease"; Poster Hall
       
      • "The Impact of Sotagliflozin on Renal Function, Albuminuria and Blood Pressure in Adults with Type 1 Diabetes" (Abstract #1000)
         
    • Wednesday, September 18, 1:15 pm-2:15 pm; Session PS 100: Treatment of Cardiovascular Disease"; Poster Hall
       
      • "Sotagliflozin Reduces Markers of Arterial Stiffness in Type 1 Diabetes: Pooled Analysis from inTandem1 and inTandem2 Clinical Trials" (Abstract #1166)

    About Zynquista (sotagliflozin)

    Discovered using Lexicon's unique approach to gene science, Zynquista is an oral dual inhibitor of two proteins responsible for glucose regulation known as sodium-glucose co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is responsible for glucose absorption in the gastrointestinal tract, and SGLT2 is responsible for glucose reabsorption by the kidney. Zynquista is approved in the European Union (EU) for use as an adjunct to insulin therapy to improve blood sugar (glycemic) control in adults with type 1 diabetes with a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy. Outside of such approval, Zynquista is investigational and has not been approved by any other regulatory authority for type 1 or type 2 diabetes.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including statements relating to Lexicon's long-term outlook on its business, the commercialization of XERMELO (telotristat ethyl) and Zynquista (sotagliflozin), and the clinical development of, the regulatory filings for, and the potential therapeutic and commercial potential of telotristat ethyl, sotagliflozin, LX2761 and LX9211. 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 XERMELO, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of telotristat ethyl, sotagliflozin, LX2761, LX9211 and its other potential 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 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, 2018, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.
    Head of Investor Relations and Corporate Strategy
    Lexicon Pharmaceuticals
    (281) 863-3383

    For Media Inquiries:

    Chas Schultz
    Executive Director, Corporate Communications and Patient Advocacy
    Lexicon Pharmaceuticals
    (281) 863-3421

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  44. THE WOODLANDS, Texas, Aug. 30, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that Jeffrey L. Wade, J.D., Executive Vice President, Corporate and Administrative Affairs and Chief Financial Officer, will present at the following conference:

    • 2019 Wells Fargo Securities Healthcare Conference on Thursday, September 5, 2019 at 2:30 p.m. EDT in New York, NY.             

    A live audio webcast for this conference will be available in the "Events" section of the Lexicon website at www.lexpharma.com/. An archived version of the webcast will be available on the website for two weeks.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated biopharmaceutical company with a mission of pioneering medicines that transform…

    THE WOODLANDS, Texas, Aug. 30, 2019 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (NASDAQ:LXRX) today announced that Jeffrey L. Wade, J.D., Executive Vice President, Corporate and Administrative Affairs and Chief Financial Officer, will present at the following conference:

    • 2019 Wells Fargo Securities Healthcare Conference on Thursday, September 5, 2019 at 2:30 p.m. EDT in New York, NY.             

    A live audio webcast for this conference will be available in the "Events" section of the Lexicon website at www.lexpharma.com/. An archived version of the webcast will be available on the website for two weeks.

    About Lexicon Pharmaceuticals

    Lexicon is a fully integrated 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. In addition to its first commercial product, XERMELO, Lexicon has a pipeline of promising drug candidates in clinical and preclinical development in diabetes and metabolism, oncology and neuropathic pain. For additional information, please visit www.lexpharma.com.

    Safe Harbor Statement

    This press release contains "forward-looking statements," including 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 those relating to Lexicon's ability to meet its capital requirements, successfully conduct preclinical and clinical development of its drug candidates, obtain necessary regulatory approvals, 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, that 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, 2018, 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.

    For Investor Inquiries:

    Kimberly Lee, D.O.
    Head of Investor Relations and Corporate Strategy
    Lexicon Pharmaceuticals
    (281) 863-3383

    For Media Inquiries:

    Chas Schultz
    Executive Director, Corporate Communications and Patient Advocacy
    Lexicon Pharmaceuticals
    (281) 863-3421

    Primary Logo

    View Full Article Hide Full Article