Lexicon Pharmaceuticals Reports Second Quarter 2022 Financial Results and Provides Business Update

Sotagliflozin New Drug Application for Heart Failure Accepted for Review by FDA,with PDUFA Action Date Anticipated in May 2023

LX9211 Phase 2 Clinical Proof-of-Concept Achieved in Painful Diabetic Neuropathy, Promising Novel Mechanism of Action in Neuropathic Pain

Conference Call and Webcast at 5:00 pm Eastern Time

THE WOODLANDS, Texas, Aug. 02, 2022 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months ended June 30, 2022 and provided an update on key milestones.

“We received acceptance last week of our New Drug Application (NDA) for sotagliflozin for the treatment of heart failure with a standard review assigned by the FDA and a PDUFA action date anticipated in May 2023,” said Lonnel Coats, Lexicon’s chief executive officer. “As we mentioned in the announcement of the acceptance, we are seeking a broad heart failure label in the NDA, informed by our regulatory discussions, that encompasses heart failure patients with and without diabetes. We believe that the results of SOLOIST-WHF in patients admitted for recent worsening heart failure will be an important element distinguishing our proposed label.”

“In another major accomplishment this quarter, we announced positive top-line results from our Phase 2 RELIEF-DPN-1 study of LX9211 in painful diabetic neuropathy at the end of June, achieving proof-of-concept for LX9211 with its novel mechanism of action in a historically difficult to treat indication,” Mr. Coats continued. “We expect to report top-line results in the fourth quarter of this year from a second proof-of-concept study of LX9211 in post-herpetic neuralgia. We believe that our recent achievements for both sotagliflozin and LX9211 have the potential to be transformative for our organization, our stakeholders, and most importantly, patients.”

Second Quarter Highlights

Sotagliflozin

• A poster was presented at the 6th Annual HEART IN DIABETES Conference evaluating the effect of sotagliflozin on major adverse cardiovascular events (MACE: cardiovascular [CV] death, non-fatal myocardial infarction [MI] and non-fatal stroke) across the sotagliflozin clinical program of over 20,000 patients with type 1 or type 2 diabetes. The results showed that treatment with sotagliflozin was associated with a statistically significant and clinically meaningful reduction in MACE in patients with T1D and T2D.
• A new analysis of data from the SCORED Phase 3 clinical trial of sotagliflozin was presented at the 82nd Scientific Sessions of the American Diabetes Association. The analysis showed that treatment with sotagliflozin significantly reduced HbA1c overall and across prespecified subgroups, including those with stage 4 chronic kidney disease with a severe decrease in glomerular filtration rate (eGFR