Patient insights informed the development of pilavapadin, Lexicon’s investigational, novel, non-opioid treatment for people suffering from DPNPTHE WOODLANDS, Texas, July 18, 2025 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that data from a study of patients describing the impact of diabetic peripheral neuropathic pain (DPNP) despite treatment with standard of care will be presented at the 7th Annual Meeting of the American Society of Pain and Neuroscience (ASPN 2025). Th ...

Pilavapadin (LX9211) for DPNP - The PROGRESS Phase 2b study identified the 10 mg dose of pilavapadin as the most clinically meaningful for treating Diabetic Peripheral Neuropathic Pain (DPNP) [7] - Post-hoc analysis of the PROGRESS study reaffirmed the 10 mg dose, showing statistically significant results (p = 0.04) when combining the 10 mg and 20/10 mg arms [11] - The 10 mg dose of pilavapadin had a study completion rate of 87.8%, similar to the placebo group's 87.9% [13] - Approximately 60% of U S patients with DPNP have tried multiple treatments, indicating a high unmet need and sizable market opportunity [15] LX9851 for Obesity and Related Metabolic Disorders - LX9851 is a first-in-class, potent, and selective orally bioavailable ACSL5 inhibitor with the potential to address unmet needs in obesity and related cardiometabolic disorders [17] - IND filing for LX9851 is on track for 2025 [20] Sotagliflozin - A Lancet Diabetes & Endocrinology publication highlighted the unique efficacy benefits of sotagliflozin, showing a reduced risk of major adverse cardiovascular events (MACE) with a Hazard Ratio (HR) of 0.77 (95% CI 0 65-0 91), p=0 0020 [23] - The cumulative incidence of total MACE was 10.0 per 100 patients in the sotagliflozin group [23] - Viatris is undertaking ex-US, ex-EU registration and regional development of sotagliflozin [21] Financials - Total revenues for FY 2024 were $31.1 million, compared to $1.2 million in FY 2023 [26] - Lexicon anticipates total operating expenses between $135 million and $145 million for full year 2025 [29]

Corporate Presentation April 2025 1 Forward-Looking Statements 2 • This presentation, including any oral presentation accompanying it, contains "forward-looking statements," including statements about Lexicon's strategy and operating performance and events or developments that we expect or anticipate will occur in the future, such as projections of our future results of operations or of our financial condition, the potential therapeutic and commercial potential of pilavapadin (LX9211), LX9851, sotagliflozin ...

1 Forward-Looking Statements 2 • This presentation, including any oral presentation accompanying it, contains "forward-looking statements," including statements about Lexicon's strategy and operating performance and events or developments that we expect or anticipate will occur in the future, such as projections of our future results of operations or of our financial condition, the potential therapeutic and commercial potential of pilavapadin (LX9211), LX9851, sotagliflozin and our other drug programs, the ...

Core Insights - Lexicon Pharmaceuticals is set to present data on sotagliflozin's ability to reduce hypoglycemic events in type 1 diabetes patients at the 85th Scientific Sessions of the American Diabetes Association on June 22, 2025 [1][3] - The company will also present topline data from the PROGRESS Phase 2b study on pilavapadin (LX9211) for diabetic peripheral neuropathic pain during the same event [1][3] Sotagliflozin Presentation - The presentation titled "Sotagliflozin Added to Insulin Reduces the Risk of Clinically Important Hypoglycemic Events in Adults with Type 1 Diabetes Regardless of Kidney Function" will take place on June 22, 2025, from 4:00-4:15 p.m. CT [3] - Clinical efficacy data for sotagliflozin will be segmented by kidney function subgroups based on Estimated Glomerular Filtration Rate (eGFR) [2] PROGRESS Study Overview - The PROGRESS study began in December 2023, enrolling 496 adult patients with diabetes and moderate to severe diabetic peripheral neuropathic pain [6] - The study is placebo-controlled, focusing on changes in pain levels over an 8-week period with various dosages of pilavapadin [6][7] About Sotagliflozin - Sotagliflozin is an oral inhibitor targeting SGLT2 and SGLT1 proteins, which are involved in glucose regulation [5] - The drug has been studied in approximately 20,000 patients across various conditions, including heart failure and chronic kidney disease [5] About Diabetic Peripheral Neuropathic Pain (DPNP) - DPNP is a chronic complication of diabetes affecting around 9 million patients in the U.S., causing symptoms like burning pain and numbness [8]

Lexicon Pharmaceuticals (LXRX) 2025 Conference June 05, 2025 12:50 PM ET Speaker0 Okay. Thanks for tuning in to the next session. I'm Andrew Tsai, senior biotech analyst at Jefferies, and it's my pleasure to have the Lexicon team with me today. To my direct left, Mike Exton, CEO. To his left, Craig Granowitz, CMO. And to Craig's left is Scott Coyante, CFO. Welcome, all of you. Speaker1 Yeah. Thank you. How's it So Speaker0 maybe spend a couple minutes talking about the Lexicon story, what you're working on, ...

Group 1 - Lexicon Pharmaceuticals will participate in a fireside chat at the 2025 Jefferies Global Healthcare Conference on June 5 at 12:50 p.m. ET [1] - The event will be accessible live and as a replay on the Company's website [1] Group 2 - Lexicon Pharmaceuticals is a biopharmaceutical company focused on pioneering medicines that transform patients' lives [2] - The Genome5000™ program has enabled Lexicon to study nearly 5,000 genes, identifying over 100 protein targets with significant therapeutic potential [2] - The company has advanced multiple medicines to market and has a pipeline of drug candidates in various stages of development for conditions such as heart failure, neuropathic pain, obesity, cardiology, and diabetes [2]

Financial Data and Key Metrics Changes - The company reported approximately $195 million in cash and investments as of the end of March [3] - In Q1, the company generated about $1.4 million in sales for its heart failure drug, Impefa, maintaining sales levels from previous quarters despite a scaled-down commercial footprint [20] Business Line Data and Key Metrics Changes - The Phase 2b PROGRESS study for pilovaparin demonstrated that the 10 mg daily dose outperformed the 20 mg dose, supporting its efficacy for diabetic peripheral neuropathic pain [12] - The company has seen no sales growth for Impefa this year but expects to maintain sales in the U.S. while pursuing regulatory approvals in other countries [20][21] Market Data and Key Metrics Changes - There are approximately 9 million people in the U.S. diagnosed with diabetic peripheral neuropathic pain, indicating a significant market opportunity for new treatments [5] - The company is actively pursuing regulatory approvals in the UAE, Saudi Arabia, and Canada for Impefa, which could lead to meaningful sales growth outside the U.S. [21] Company Strategy and Development Direction - The company is focusing on partnerships to enhance the development and commercialization of its assets, particularly pilovaparin, which has potential for multiple indications [17] - The company aims to maintain its presence in the market for Impefa while building evidence for its efficacy through ongoing studies [22] Management's Comments on Operating Environment and Future Outlook - Management highlighted the desperate need for new non-opioid treatments in the context of the opioid crisis, particularly for diabetic peripheral neuropathic pain [6] - The company is optimistic about the upcoming catalysts, including data presentations and regulatory meetings, which are expected to drive value for its development pipeline [45] Other Important Information - The company has entered into a partnership with Novo Nordisk for its obesity asset, receiving $75 million in upfront payments and potential future milestones totaling up to $1 billion [38] - The SONata HCM clinical trial for sotagliflozin is designed to include both obstructive and nonobstructive hypertrophic cardiomyopathy, with regulatory approvals obtained in 20 countries [33][34] Q&A Session Summary Question: Can you provide insights on pilovaparin's next regulatory steps? - The company plans to present data from the Phase 2b study at major medical meetings and will have an end-of-Phase 2 meeting with the FDA to finalize Phase 3 designs [14][15] Question: What are the commercial prospects for soragliflozin? - The company has maintained sales of Impefa in the U.S. and is pursuing regulatory approvals in other countries, expecting meaningful sales growth as these approvals are granted [20][21] Question: What is the rationale for evaluating sotagliflozin in both forms of HCM? - The underlying pathophysiology of HCM is similar in both obstructive and nonobstructive forms, making sotagliflozin a promising candidate for treatment [24][25] Question: How is the partnership with Novo Nordisk structured? - The partnership allows Novo to take over the IND submission process after Lexicon completes the IND enabling studies, which are expected to be finished this year [41][42]

Financial Performance - Revenues for Q1 2025 were approximately $1.3 million, up from $1.1 million in Q1 2024, primarily from sales of INPEFA[79]. - Research and development expenses increased by 6% to $15.3 million in Q1 2025 from $14.4 million in Q1 2024, driven by a 12% rise in third-party services[81]. - Selling, general and administrative expenses decreased by 64% to $11.6 million in Q1 2025 from $32.1 million in Q1 2024[82]. - Net loss for Q1 2025 was $25.3 million, or $0.07 per share, compared to a net loss of $48.4 million, or $0.20 per share, in Q1 2024[86]. - The company had an accumulated deficit of approximately $2.0 billion as of March 31, 2025[77]. Cash and Investments - Cash, cash equivalents, and short-term investments totaled $194.8 million as of March 31, 2025, down from $238.0 million at the end of 2024[90]. - Current unrestricted cash and investments amount to approximately $194.8 million as of March 31, 2025, sufficient to fund operations for at least the next 12 months[101]. - The company has approximately $194.8 million in cash and cash equivalents, with limited market and credit risk exposure[104]. Debt and Financing - The company entered into an Open Market Sale Agreement with Jefferies LLC for the potential sale of up to $75 million in common stock[91]. - A seventh amendment to the loan agreement with Oxford included a prepayment of $45 million and modifications to financial covenants[92]. - The company repaid $45 million to Oxford in April 2025, with additional payments of $20.2 million, $30.2 million, and $11.6 million due in the fiscal years ending December 31, 2027, 2028, and 2029 respectively[93]. - As of March 31, 2025, the company maintained a minimum cash balance of $29 million in a blocked account, in compliance with its debt covenants[94]. - The outstanding Oxford Term Loans bear interest at a floating rate tied to the 1-month CME Term SOFR rate, maturing by March 2029[105]. - If liquidity needs arise, the company may seek additional financing through collaborations or selling equity, which could dilute stockholder value[102]. Regulatory and Collaboration Updates - The company received Fast Track designation from the FDA for pilavapadin in diabetic peripheral neuropathic pain[74]. - The company is pursuing regulatory approval for ZYNQUISTA (sotagliflozin) for type 1 diabetes, with ongoing proceedings related to its NDA[70]. - The company entered into an exclusive license agreement with Novo Nordisk A/S in March 2025, receiving an upfront payment of $45 million and potential milestone payments totaling up to $960 million[95]. - An exclusive license agreement with Viatris for the development of sotagliflozin resulted in an upfront payment of $25 million in October 2024[96]. - Upon regulatory approval of sotagliflozin, the company will make royalty payments totaling $4.5 million in three annual installments of $1.5 million[97]. Future Outlook - The company expects substantial future capital requirements, influenced by ongoing R&D success and new collaborations[100].

Group 1 - Lexicon Pharmaceuticals reported a quarterly loss of $0.07 per share, better than the Zacks Consensus Estimate of a loss of $0.10, and an improvement from a loss of $0.20 per share a year ago, resulting in an earnings surprise of 30% [1] - The company posted revenues of $1.26 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 23.52%, compared to year-ago revenues of $1.13 million [2] - Lexicon shares have declined approximately 8.8% since the beginning of the year, while the S&P 500 has seen a decline of -0.6% [3] Group 2 - The current consensus EPS estimate for the upcoming quarter is -$0.09 on revenues of $2.37 million, and for the current fiscal year, it is -$0.37 on revenues of $15.43 million [7] - The Zacks Industry Rank for Medical - Biomedical and Genetics is in the top 35% of over 250 Zacks industries, indicating a favorable outlook for the industry [8] - Lexicon has a Zacks Rank of 2 (Buy), suggesting that the stock is expected to outperform the market in the near future [6]