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–Treatment with HU6 led to significant reductions in body fat and abdominal visceral fat while preserving skeletal muscle in patients with obesity-related heart failure with preserved ejection fraction (HFpEF) – – HU6, a novel, once-daily, oral therapy in Phase 2 clinical development, is…
March 11, 2025 07:05 AM Eastern Daylight Time BRISBANE, Calif.–(BUSINESS WIRE)–CareDx, Inc. (Nasdaq: CDNA) – The Transplant Company™ – a leading precision medicine company focused on the discovery, development, and commercialization of clinically differentiated, high-value healthcare solutions for transplant patients and caregivers – today announced that AlloSure® is now commercially […]
BOSTON, March 11, 2025 (GLOBE NEWSWIRE) — Medera Inc. (“Medera”), a clinical-stage biopharmaceutical company focused on targeting difficult-to-treat and currently incurable diseases by developing a range of next-generation therapeutics, today announced that patient dosing has been completed in its MUSIC-HFrEF Phase 1/2a clinical trial of the gene therapy candidate SRD-001 in patients with heart failure with reduced ejection fraction (HErEF). HErEF is a prevalent form of heart disease that accounts for half of an estimated 64.3 million heart failure cases worldwide and is currently considered a mass market incurable disease. The MUSIC-HFrEF trial is an open-label, uncontrolled study investigating SRD-001 across two cohorts with six patients dosed with SRD-001 in Cohort A (low-dose 3×1013 vg per patient) and three patients dosed in Cohort B (high-dose 4.5×1013 vg per patient). Preliminary data was presented at the 7th Annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) in May 2024 on a subset of the patients dosed. The data showed an acceptable safety profile in patients with advanced heart failure and further demonstrated clinically meaningful improvements in multiple metrics of heart function and patient heath at six and 12 months post infusion. Topline data with 12-month follow-up will be reported in due course. “The completion of enrollment in the Phase 1/2a trial marks a crucial milestone for this cardiac gene therapy trial in patients with heart failure with reduced ejection fraction (HFrEF). We are encouraged that this therapy may help patients with advanced heart failure who have few therapeutic options,” said Brian Jaski, M.D., the Principal Investigator of MUSIC-HFrEF and Director of Cardiology at San Diego Cardiac Center. “We are very excited and encouraged by these results, which indicate that our various new designs such as optimized dosages seem to be making differences,” said Ronald Li, Ph.D., CEO and co-founder of Medera. For more information on the MUSIC-HFrEF trial, please visit clinicaltrials.gov/study/NCT04703842. On September 5, 2024, Medera and Keen Vision Acquisition Corporation (“KVAC”) (NASDAQ:KVAC, KVACW), announced they had entered into a definitive merger agreement (the “Merger Agreement”). About SRD-001 SRD-001 is an investigational gene therapy candidate that contains an adeno-associated virus serotype 1 (AAV1) vector expressing the transgene for sarco(endo)plasmic reticulum Ca2+ ATPase 2a isoform (SERCA2a), in anti-AAV1 neutralizing antibody (NAb) negative subjects with ischemic or non-ischemic cardiomyopathy and New York Heart Association (NYHA) class III/IV symptoms of heart failure with reduced ejection fraction (HFrEF). About Heart Failure with reduced Ejection Fraction (HFrEF) HErEF is a complex cardiovascular pathophysiological syndrome that impairs normal cardiac function and results in the inability of the heart to pump a sufficient supply of blood to meet the body demand. Once established, HFrEF is generally progressive, irreversible, associated with debilitating symptoms, frequent re-hospitalizations and high mortality rates. An urgent need exists for disease modifying therapies, such as SRD-001, which aim to reverse the pathophysiology of HFrEF. About Medera Medera is a clinical-stage biopharmaceutical company focused on targeting difficult-to-treat and currently incurable diseases by developing a range of next-generation therapeutics. Medera operates via its two preclinical and clinical business units, Novoheart and Sardocor, respectively. Novoheart capitalizes on the world’s first and award-winning “mini-Heart” Technology for revolutionary disease modelling and drug discovery, uniquely enabling the modelling of human-specific diseases and discovery of therapeutic candidates free from species-specific differences in accordance to the FDA Modernization Act 2.0. Novoheart’s versatile technology platform provides a range of state-of-the-art automation hardware and software as well as screening services, for human-specific disease modelling, therapeutic target discovery and validation, drug toxicity and efficacy screening, and dosage optimization carried out in the context of healthy and/or diseased human heart chambers and tissues. Global pharmaceutical and academic leaders are using Novoheart’s technology platform for their drug discovery and development purposes. The Novoheart platform has facilitated and accelerated the development of Sardocor’s lead therapeutic candidates that are currently in clinical trials. Sardocor is dedicated to the clinical development of novel next-generation therapies for Medera. Leveraging Novoheart’s human-based drug discovery and validation platforms, Sardocor aims to expedite drug development and regulatory timelines for its gene and cell therapy pipeline. Sardocor has received Investigational New Drug (IND) clearances from the FDA for three ongoing AAV-based cardiac gene therapy clinical trials targeting Heart Failure with Reduced Ejection Fraction (HFrEF), Heart Failure with Preserved Ejection Fraction (HFpEF) with the Fast Track Designation, and Duchenne Muscular Dystrophy-associated Cardiomyopathy (DMD-CM) with the Orphan Drug Designation. Additionally, Sardocor’s pipeline includes four preclinical gene therapy and three preclinical small molecule candidates targeting various cardiac, pulmonary, and vascular diseases. For more information, please visit www.medera.bio. About Keen Vision Acquisition Corporation Keen Vision Acquisition Corp (“KVAC”), listed on Nasdaq, is a blank check company incorporated for the purpose of effecting a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses or entities. KVAC is focused on biotechnology, consumer goods or agriculture opportunities, which are also evaluated on their sustainability, environmental, social, and corporate governance (“ESG”) imperatives. For more information, please visit www.kv-ac.com. Forward-Looking Statements Certain statements included in this press release are not historical facts but are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this press release are forward-looking statements. Any statements that refer to projections, forecasts or other characterizations of future events or circumstances, including any underlying assumptions, are also forward-looking statements. In some cases, you can identify forward-looking statements by words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “strategy,” “future,” “opportunity,” “may,” “target,” “should,” “will,” “would,” “will be,” “will continue,” “will likely result,” “preliminary,” or similar expressions that predict or indicate future events or trends or that are not statements of historical matters, but the absence of these words does not mean that a statement is not forward-looking. Forward-looking statements include, without limitation, KVAC’s, Medera’s, or their respective management teams’ expectations concerning the outlook for their or Medera’s business, productivity, plans, and goals for future operational improvements and capital investments, operational performance, future market conditions, or economic performance and developments in the capital and credit markets and expected future financial performance, including expected net proceeds, expected additional funding, the percentage of redemptions of KVAC’s public shareholders, growth prospects and outlook of Medera’ operations, individually or in the aggregate, including the achievement of project milestones, commencement and completion of commercial operations of certain of Medera’s projects, as well as any information concerning possible or assumed future results of operations of Medera. Forward-looking statements also include statements regarding the expected benefits of the transactions contemplated by the merger (“Transaction”). The forward-looking statements are based on the current expectations of the respective management teams of Medera and KVAC, as applicable, and are inherently subject to uncertainties and changes in circumstance and their potential effects. There can be no assurance that future developments will be those that have been anticipated. These forward-looking statements involve a number of risks, uncertainties or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements. These risks and uncertainties include, but are not limited to, (i) the risk that the Transaction may not be completed in a timely manner or at all, which may adversely affect the price of KVAC’s securities; (ii) the risk that the Transaction may not be completed by KVAC’s business combination deadline and the potential failure to obtain an extension of the business combination deadline if sought by KVAC; (iii) the failure to satisfy the conditions to the consummation of the Transaction, including the adoption of the Merger Agreement by the shareholders of KVAC and the receipt of certain regulatory approvals; (iv) market risks; (v) the occurrence of any event, change or other circumstance that could give rise to the termination of the Merger Agreement; (vi) the effect of the announcement or pendency of the Transaction on Medera’s business relationships, performance, and business generally; (vii) the outcome of any legal proceedings that may be instituted against Medera or KVAC related to the Merger Agreement or the Transaction; (viii) failure to realize the anticipated benefits of the Transaction; (ix) the inability to maintain the listing of KVAC’s securities or to meet listing requirements and maintain the listing of Medera’s securities on Nasdaq; (x) the inability to implement business plans, forecasts, and other expectations after the completion of the Transaction, identify and realize additional opportunities, and manage its growth and expanding operations; (xi) risks related to Medera’s ability to develop, license or acquire new therapeutics; (xii) the risk that Medera will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; (xiii) the risk of product liability or regulatory lawsuits or proceedings relating to Medera’s business; (xiv) uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; (xv) risks related to regulatory review, and approval and commercial development; (xvi) risks associated with intellectual property protection; (xvii) Medera’s limited operating history and risk that it may never successfully commercialise its products; (xviii) Medera expects to continue to incur significant losses and may never achieve or maintain profitability; and (xix) the risk that additional financing in connection with the Transaction may not be raised on favorable terms. The foregoing list is not exhaustive, and there may be additional risks that neither KVAC nor Medera presently knows or that KVAC and Medera currently believe are immaterial. You should carefully consider the foregoing factors, any other factors discussed in this press release and the other risks and uncertainties described in the “Risk Factors” section of KVAC’s Annual Report on Form 10-K for the year ended December 31, 2023, which was filed with the SEC on March 29, 2024, the risks to be described in the registration statement, which will include a preliminary proxy statement/prospectus, and those discussed and identified in filings made with the SEC by KVAC from time to time. Medera and KVAC caution you against placing undue reliance on forward-looking statements, which reflect current beliefs and are based on information currently available as of the date a forward-looking statement is made. Forward-looking statements set forth in this press release speak only as of the date of this press release. Neither Medera nor KVAC undertakes any obligation to revise forward-looking statements to reflect future events, changes in circumstances, or changes in beliefs. In the event that any forward-looking statement is updated, no inference should be made that Medera or KVAC will make additional updates with respect to that statement, related matters, or any other forward-looking statements. Any corrections or revisions and other important assumptions and factors that could cause actual results to differ materially from forward-looking statements, including discussions of significant risk factors, may appear, up to the consummation of the Transaction, in KVAC’s public filings with the SEC, and which you are advised to review carefully. Important Information for Investors and Shareholders In connection with the Transaction, KVAC and Medera filed a registration statement with the SEC, which includes a prospectus with respect to the securities to be issued in connection with the Transaction and a proxy statement to be distributed to holders of KVAC’s ordinary shares in connection with KVAC’s solicitation of proxies for the vote by KVAC’s shareholders with respect to the Transaction and other matters to be described in the Registration Statement (the “Proxy Statement”). After the SEC declares the registration statement effective, KVAC plans to mail copies to shareholders of KVAC as of a record date to be established for voting on the Transaction. This press release does not contain all the information that should be considered concerning the Transaction and is not a substitute for the registration statement, Proxy Statement or for any other document that KVAC may file with the SEC. Before making any investment or voting decision, investors and security holders of KVAC are urged to read the registration statement and the Proxy Statement, and any amendments or supplements thereto, as well as all other relevant materials filed or that will be filed with the SEC in connection with the Transaction as they become available because they will contain important information about, Medera, KVAC and the Transaction. Investors and security holders will be able to obtain free copies of the registration statement, the Proxy Statement and all other relevant documents filed or that will be filed with the SEC by KVAC through the website maintained by the SEC at www.sec.gov. In addition, the documents filed by KVAC may be obtained free of charge from KVAC’s website at https://www.kv-ac.com or by directing a request to info@kv-ac.com. The information contained on, or that may be accessed through, the websites referenced in this press release is not incorporated by reference into, and is not a part of, this press release. Participants in the Solicitation KVAC, Medera and their respective directors, executive officers and other members of management and employees may, under the rules of the SEC, be deemed to be participants in the solicitations of proxies in connection with the Transaction. For more information about the names, affiliations and interests of KVAC’s directors and executive officers, please refer to KVAC’s annual report on Form 10-K filed with the SEC on March 29, 2024, which can be found at https://www.sec.gov/ix?doc=/Archives/edgar/data/1889983/000121390024027973/ea0201104-10k_keenvision.htm and registration statement, Proxy Statement and other relevant materials filed with the SEC in connection with the Transaction when they become available. Additional information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, which may, in some cases, be different than those of KVAC’s shareholders generally, will be included in the registration statement and the Proxy Statement and other relevant materials when they are filed with the SEC when they become available. Shareholders, potential investors and other interested persons should read the registration statement and the Proxy Statement and other such documents carefully, when they become available, before making any voting or investment decisions. You may obtain free copies of these documents from the sources indicated above. No Offer or Solicitation This communication shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offering of securities in the Transaction shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. Contacts: Keen Vision Acquisition CorporationAlex DavidkhanianChief Financial OfficerEmail: alex.davidkhanian@kv-ac.com MederaInvestor RelationsStephanie CarringtonICR HealthcareStephanie.Carrington@icrhealthcare.com(646) 277-1282 Media RelationsSean LeousICR HealthcareSean.Leous@icrhealthcare.com(646) 866-4012
FDA 510(k) clearance of Caristo’s CaRi-Plaque™ technology advances AI innovator’s U.S. commercialization, as it looks to roll out to hospitals, health systems and longevity clinics The CaRi-Plaque technology delivers AI-driven precision in coronary plaque detection, helping cardiologists…
WASHINGTON, March 10, 2025 /PRNewswire/ — A study unveiled today, March 10, 2025, at the Cardiovascular Research Technologies (CRT) 2025 meeting in Washington, DC, has demonstrated that the EggNest Complete Radiation Protection System provides superior scatter radiation protection for…
SUNNYVALE, Calif., March 10, 2025 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary diseases, today announces that the Japan Patent Office has granted Japanese Patent No. 7641330 titled “Radial and Transendocardial Delivery Catheter” with a patent term that will expire on or after September 30, 2034. “This new patent in Japan adds to our growing patent position with respect to minimally invasive catheter-based delivery systems for cell and gene-based therapies to the heart,” said Dr. Peter Altman, BioCardia CEO. “Our clinical cell therapy candidates for the treatment of ischemic cardiomyopathies benefit greatly from the performance of these systems, as will current and future biotherapeutic partners supported by our extensive preclinical and clinical experience. Japan is an important initial market for these therapies because of their national commitment to support novel and cost-effective cell therapy solutions for their aging population while also developing the Japanese stem cell industry (1).” BioCardia’s newly issued Japanese Patent No. 7641330 describes minimally invasive interventional biotherapeutic delivery catheters to deliver biologic therapies to target sites in the heart. This minimally invasive delivery approach enables optimal treatment at the sites where needed, minimizes off-target toxicities, and avoids the need for surgical access to the heart. The allowed claims cover BioCardia’s helical needle-tipped catheter technology platform, which available data supports is the safest and most efficient approach for biotherapeutic delivery to the heart (2, 3). BioCardia believes its Helix System to be the only catheter-based intramyocardial delivery system in active clinical use. BioCardia has secured an extensive portfolio of issued patents and pending patent applications around cell, exosome, and microRNA biotherapeutic candidates, minimally invasive biotherapeutic delivery platforms, and advanced cardiac imaging technologies. These inventions have resulted from the pursuit of its ongoing mission to develop new therapies for the patients suffering from cardiovascular disease. About BioCardia BioCardia, Inc., headquartered in Sunnyvale, California, is a global leader in cellular and cell-derived therapeutics for the treatment of cardiovascular and pulmonary disease. CardiAMP® autologous and CardiALLO™ allogeneic cell therapies are the Company’s biotherapeutic platforms with three clinical stage product candidates in development. These therapies are enabled by its Helix biotherapeutic delivery and Morph® vascular navigation product platforms. Forward Looking Statements: This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include, among other things, references to the Company’s investigational product candidates and biotherapeutic delivery capabilities. These forward-looking statements are made as of the date of this press release, and BioCardia assumes no obligation to update the forward-looking statements. We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey the uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results may differ materially from the forward-looking statements contained in this press release. As a result of these factors, we cannot assure you that the forward-looking statements in this press release will prove to be accurate. Additional factors that could materially affect actual results can be found in BioCardia’s Form 10-K filed with the Securities and Exchange Commission on March 27, 2024, under the caption titled “Risk Factors.” and in our subsequently filed Quarterly Reports on Form 10-Q. BioCardia expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law. Konomi K, Tobita M, Kimura K, Sato D. New Japanese initiatives on stem cell therapies. Cell Stem Cell. 2015 Apr 2;16(4):350-2.Mitsutake Y, Pyum WB, Rouy D, Wong Po Foo C, Stertzer SH, Altman P, Ikeno F. Improvement of local cell delivery using Helix Transendocardial Delivery Catheter in a porcine heart, Int Heart J. 2017. Raval AN and Pepine CJ. Clinical Safety Profile of Transendocardial Catheter Injection Systems: A Plea for Uniform Reporting, Cardiovasc Revasc Med, 2021. CONTACT: Media Contact:
Miranda Peto, Marketing / Investor Relations
Email: mpeto@BioCardia.com
Phone: 650-226-0120
Investor Contact:
David McClung, Chief Financial Officer
Email: investors@BioCardia.com
Phone: 650-226-0120
– Launch-HTN met its primary endpoint with lorundrostat 50 mg dose achieving a 16.9 mmHg reduction in systolic blood pressure, and a 9.1 mmHg placebo-adjusted reduction (p-value < 0.0001) assessed by automated office blood pressure at week 6 –– Launch-HTN met a predefined endpoint with lorundrostat 50 mg dose achieving a 19.0 mmHg reduction in systolic blood pressure, and an 11.7 mmHg placebo-adjusted reduction (p-value < 0.0001) assessed by automated office blood pressure at end of treatment, week 12 –– Advance-HTN met its primary endpoint with lorundrostat 50 mg dose achieving a highly statistically significant 7.9 mmHg placebo-adjusted reduction assessed by 24hr ABPM at end of treatment, week 12 –– Lorundrostat demonstrated a favorable safety and tolerability profile in both pivotal trials –– Full results from Advance-HTN to be presented on March 29, 2025, at the American College of Cardiology Scientific Sessions –– Conference call today at 8:00 a.m. ET – RADNOR, Pa., March 10, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced positive topline data from its pivotal Launch-HTN Phase 3 and pivotal Advance-HTN Phase 2 trials evaluating the efficacy and safety of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN). Both trials successfully achieved statistical significance and were clinically meaningful in their pre-specified primary efficacy endpoints and demonstrated a favorable safety and tolerability profile. “The positive results and clinically meaningful reduction in blood pressure observed in the Launch-HTN and Advance-HTN trials show us that lorundrostat has the potential to be a transformative new therapy for the approximately 15 to 20 million patients with uncontrolled hypertension in the United States,” stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “We have now completed three successful clinical trials demonstrating the efficacy, safety and tolerability of lorundrostat and the importance of targeting dysregulated aldosterone. We believe the clinical profile observed for lorundrostat supports the potential regulatory approval of this novel agent and its significant commercial value. We appreciate the commitment and hard work of the clinical investigators, site staff, the Mineralys and Cleveland Clinic research teams, and especially the trial subjects who volunteered to participate in our program.” Efficacy Results The Launch-HTN trial was a global, randomized, double-blinded, placebo-controlled Phase 3 trial, which enrolled eligible adult participants who failed to achieve their blood pressure goal despite being on two to five antihypertensive medications. Launch-HTN reflects the real-world setting for clinicians by utilizing automated office blood pressure (AOBP) measurement and allowing participants to stay on their existing medications. The trial met its endpoints demonstrating clinically meaningful, statistically significant mean reduction from baseline in placebo-adjusted systolic blood pressure at week six and the benefit was sustained with potential further reduction through week 12. Launch-HTN Phase 3 Trial (automated office systolic blood pressure measure, n=1,083) Week 6 (50 mg pooled)Week 12 Absolute ReductionPlacebo-Adjusted ReductionAbsolute ReductionPlacebo-Adjusted Reduction50 mg-16.9 mmHg-9.1 mmHg (p
CRT 2025 Late Breaking Science features largest head-to-head randomized control TAVR trial to primarily enroll women using the two most widely used global TAVR devices GALWAY, Ireland and WASHINGTON, March 9, 2025 /PRNewswire/ — Medtronic plc (NYSE: MDT), a global leader in healthcare…
Topline Results for Phase 2b PROGRESS Study of Pilavapadin (LX9211) in Diabetic Peripheral Neuropathic Pain (DPNP); 10 mg dose to Advance into Phase 3 Development Leaner organization focused on Advancing Strong Pipeline Conference Call and Webcast at 5:00 pm ET THE WOODLANDS, Texas, March 06, 2025 (GLOBE NEWSWIRE) — Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months and year ended December 31, 2024, and provided an update on key corporate milestones and accomplishments. “In 2024, Lexicon made progress on our Lead to Succeed strategy, resulting in a complete repositioning of the company to focus on advancing our R&D pipeline,” said Mike Exton, Ph.D., Lexicon’s chief executive officer and director. “With R&D efforts our core priority, we were pleased to report progress on three programs. First, we recently reported topline results from the PROGRESS Phase 2b study of pilavapadin, our novel non-opioid, oral, investigational therapy for neuropathic pain with potential to be the first new therapy for neuropathic pain in over two decades. We met our study objectives with respect to the 10 mg dose, which achieved meaningful pain reduction versus placebo and was well-tolerated, providing support for initiation of a Phase 3 program for pilavapadin in DPNP in 2025.” “We are on track for an IND filing this year for LX9851 in obesity and other potential metabolic disorders. In parallel, we continue to build strong differentiating evidence for sotagliflozin, an SGLT1/2 inhibitor, and we are continuing to enroll a Phase 3 clinical trial in support of a potential broad indication in hypertrophic cardiomyopathy (HCM). These three pipeline opportunities are each in areas of significant unmet need, and have the potential for multiple indications, to be first or only new therapy to market, or to be meaningfully differentiated within their market.” Fourth Quarter 2024 Business and Pipeline Highlights Pilavapadin (LX9211) for DPNP Pilavapadin is an orally delivered, small molecule drug candidate for the treatment of DPNP. Pilavapadin has the potential to become the first oral non-opioid drug therapy approved in neuropathic pain in more than 20 years.Topline data in PROGRESS met the Company’s objective to identify a well-tolerated dose exhibiting meaningful pain reduction that is appropriate to advance into Phase 3 development. In the study, the 10 mg dose arm demonstrated meaningful separation in ADPS from both baseline and placebo and was well-tolerated, although the lack of separation in ADPS between the 20 mg dose arm and placebo resulted in the study not reaching statistical significance on its primary endpoint.The Company is moving toward an end of Phase 2 meeting with FDA and targeting initiation of U.S. and ex-U.S. Phase 3 trials in DPNP in 2025, while selecting a future medical meeting for release of additional clinical data later this year. LX9851 for Obesity and Associated Cardiometabolic Disorders LX9851 is a novel, non-incretin oral development candidate that inhibits ACSL5 and is in preclinical development for obesity and weight management. LX9851 is progressing in IND-enabling studies and on track for a 2025 investigational new drug (IND) application submission. Sotagliflozin for HCM Enrollment is underway in SONATA HCM, a pivotal Phase 3 placebo-controlled study with a targeted enrollment of 500 patients with obstructive or nonobstructive hypertrophic cardiomyopathy (HCM). Site initiation in the European Union and Latin America countries are well underway to further support the company’s trial execution timelines. All target sites are expected to be up and running by Q3. INPEFA (sotagliflozin) Completed reprioritization of SG&A investment to cease active promotion while continuing to make product commercially available. Zynquista (sotagliflozin) Discontinued preparation for potential Zynquista launch in type 1 diabetes following receipt of complete response letter from FDA. Data and Publications Highlights Continued to focus on generating clinical data to support differentiation of sotagliflozin, including most recent publication in The Lancet Diabetes & Endocrinology analyzing the ability of sotagliflozin to reduce the risks of life-threatening cardiovascular outcomes.The findings from the study, “Reduction in Major Adverse Cardiovascular Events with Sotagliflozin: A Prespecified Analysis of the SCORED Randomized Trial,” concluded that the ischemic benefit of sotagliflozin on both heart attack (myocardial infarction, or MI), and stroke reduction has not been observed with other SGLT inhibitors. Fourth Quarter 2024 Financial Highlights Revenues: Revenues for the fourth quarter of 2024 increased to $26.6 million from $0.7 million for the comparable period in 2023 and for the full year 2024 increased to $31.1 million from $1.2 million for the full year 2023. Revenues for both periods in 2024 reflect increased sales of INPEFA compared to 2023 and an upfront payment of $25.0 million received upon entering into the Viatris INPEFA licensing agreement in October 2024. Research and Development (R&D) Expenses: Research and development expenses for the fourth quarter of 2024 increased to $26.7 million from $14.8 million for the comparable period in 2023. Full-year research and development expenses for 2024 increased to $84.5 million from $58.9 million for the full year 2023, primarily due to investments in Phase 2 and 3 clinical trials, including the SONATA Phase 3 study of sotagliflozin in HCM and the PROGRESS Phase 2b study of pilavapadin in DPNP. Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the fourth quarter of 2024 decreased to $32.3 million from $32.6 million for the comparable period in 2023. Full-year 2024 selling, general and administrative expenses increased to $143.1 million from $114.0 million for the full year 2023. The increase in 2024 reflects higher marketing costs related to the commercialization of INPEFA and increased employee salaries and benefit costs prior to the reduction in our field force in late 2024 including severance costs associated with our strategic repositioning. Net Loss: Net loss for the fourth quarter of 2024 was $33.8 million, or $0.09 per share, as compared to a net loss of $49.8 million, or $0.20 per share, in the corresponding period in 2023. For the fourth quarters of 2024 and 2023, net loss included non-cash, stock-based compensation expense of $1.5 million and $3.2 million, respectively. Net loss for the full year 2024 was $200.4 million, or $0.63 per share, as compared to a net loss of $177.1 million, or $0.80 per share, for the full year 2023. For the full years of 2024 and 2023, net loss included non-cash, stock-based compensation expense of $13.5 million and $14.3 million, respectively. Cash and Investments: As of December 31, 2024, Lexicon had $238.0 million in cash and short-term investments, as compared to $170.0 million as of December 31, 2023. 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. A live audio webcast of the call can be accessed by visiting the Events page of the Company’s investor relations website at https://investors.lexpharma.com/. Participants who wish to ask a question may register here to receive dial-in numbers and a unique pin to join the call. An archived version of the webcast will be available on the website for 30 days. About Lexicon Pharmaceuticals Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, 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 has advanced multiple medicines to market and has a pipeline of promising drug candidates in discovery and clinical and preclinical development in heart failure, neuropathic pain, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com. Safe Harbor Statement This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, including the commercialization of its approved products and 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, 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 its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other 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 approved products and other 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, 2023, 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 DataThree Months Ended December 31, Years Ended December 31,(In thousands, except per share data) 2024 2023 2024 2023 (Unaudited) (Unaudited)Revenues: Net product revenue$1,550 $672 $6,001 $1,110 Licensing revenue 25,000 — 25,000 — Royalties and other revenue 4 30 80 94 Total revenues 26,554 702 31,081 1,204 Operating expenses: Cost of sales 348 70 616 85 Research and development, including stock-based compensation of $1,106, $1,297, $5,839 and $5,139, respectively 26,685 14,762 84,480 58,887 Selling, general and administrative, including stock-based compensation of $431, $1,915, $7,660, and $9,201, respectively 32,258 32,607 143,102 113,982 Total operating expenses 59,291 47,439 228,198 172,954 Loss from operations (32,737) (46,737) (197,117) (171,750) Interest and other expense (3,858) (5,421) (15,579) (13,101) Interest income and other, net 2,829 2,402 12,293 7,732 Net loss$(33,766) $(49,756) $(200,403) $(177,119) Net loss per common share, basic and diluted$(0.09) $(0.20) $(0.63) $(0.80) Weighted average common shares outstanding basic and diluted 361,492 244,925 320,031 221,130 As of As of Consolidated Balance Sheet DataDecember 31, 2024 December 31, 2023 (In thousands) Cash and investments$237,957 $170,026 Property and equipment, net 2,484 1,987 Goodwill 44,543 44,543 Total assets 298,420 229,429 Long-term debt, net. 100,298 99,508 Accumulated deficit (1,967,242) (1,766,839) Total stockholders’ equity 145,950 93,110 For Investor and Media Inquiries: Lisa DeFrancesco Lexicon Pharmaceuticals, Inc. lexinvest@lexpharma.com About INPEFA® (sotagliflozin)Discovered using Lexicon’s unique approach to gene science, INPEFA® (sotagliflozin) is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients. INDICATION INPEFA is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with: heart failure or type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors IMPORTANT SAFETY INFORMATION Dosing: Assess renal function and volume status and, if necessary, correct volume depletion prior to initiation of INPEFA. INPEFA dosing for patients with decompensated heart failure may begin when patients are hemodynamically stable, including when hospitalized or immediately upon discharge. Contraindications: INPEFA is contraindicated in patients with hypersensitivity to INPEFA or any of its components. Ketoacidosis: INPEFA increases the risk of ketoacidosis in patients with type 1 diabetes mellitus (T1DM). Type 2 diabetes Mellitus (T2DM) and pancreatic disorders are also risk factors. The risk of ketoacidosis may be greater with higher doses. There have been postmarketing reports of fatal events of ketoacidosis in patients with type 2 diabetes using sodium glucose transporter 2 (SGLT2) inhibitors. Before initiating INPEFA, assess risk factors for ketoacidosis. Consider ketone monitoring in patients with T1DM and consider ketone monitoring in others at risk for ketoacidosis and educate patients on the signs/symptoms of ketoacidosis. Patients receiving INPEFA may require monitoring and temporary discontinuation of therapy in clinical situations known to predispose to ketoacidosis. INPEFA is not indicated for glycemic control. Assess patients who present with signs and symptoms of metabolic acidosis or ketoacidosis, regardless of blood glucose level. If suspected, discontinue INPEFA, evaluate, and treat promptly. Monitor patients for resolution of ketoacidosis before restarting INPEFA. Volume Depletion: INPEFA can cause intravascular volume depletion which may sometimes manifest as symptomatic hypotension or acute transient changes in creatinine. There have been post-marketing reports of acute kidney injury, some requiring hospitalization and dialysis, in patients with type 2 diabetes mellitus receiving SGLT2 inhibitors. Patients with impaired renal function (eGFR < 60 mL/min/1.73 m2), elderly patients, or patients on loop diuretics may be at increased risk for volume depletion or hypotension. Before initiating INPEFA in patients with one or more of these characteristics, assess volume status and renal function, and monitor for signs and symptoms of hypotension during therapy. Urosepsis and Pyelonephritis: Treatment with SGLT2 inhibitors, including INPEFA, increases the risk for urinary tract infections. Serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalization have been reported. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly. Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues: Insulin and insulin secretagogues are known to cause hypoglycemia. INPEFA may increase the risk of hypoglycemia when combined with insulin or an insulin secretagogue. Therefore, a lower dose of insulin or insulin secretagogue may be required to minimize the risk of hypoglycemia when used with INPEFA. Necrotizing Fasciitis of the Perineum (Fournier’s Gangrene): Reports of Fournier’s Gangrene, a rare but serious and life-threatening necrotizing infection requiring urgent surgical intervention, have been identified in post-marketing surveillance in patients with diabetes mellitus receiving SGLT2 inhibitors. Assess patients who present with pain, tenderness, erythema, or swelling in the genital or perineal area, along with fever or malaise. If suspected, start treatment immediately with broad-spectrum antibiotics and, if necessary, surgical debridement. Discontinue INPEFA, closely monitor patient signs and symptoms, and provide appropriate alternative therapy for heart failure. Genital Mycotic Infections: INPEFA increases the risk of genital mycotic infections. Monitor and treat as appropriate. Urinary Glucose Test and 1,5-anhydroglucitol (1,5-AG) Assay: these are not reliable for patients taking SGLT2 inhibitors. Use alternative testing methods to monitor glucose levels. Common Adverse Reactions: the most commonly reported adverse reactions (incidence ≥ 5%) were urinary tract infection, volume depletion, diarrhea, and hypoglycemia. Drug Interactions: Digoxin: Monitor patients appropriately as there is an increase in the exposure of digoxin when coadministered with INPEFA 400 mg. Uridine 5'-diphospho-glucuronosyltransferase (UGT) Inducer: The coadministration of rifampicin, an inducer of UGTs, with sotagliflozin resulted in a decrease in the exposure of sotagliflozin. Lithium: Concomitant use of an SGLT2 inhibitor with lithium may decrease serum lithium concentrations. Monitor serum lithium concentration more frequently during INPEFA initiation and with dosage changes. Use in Specific Populations: Pregnancy and Lactation: INPEFA is not recommended during the second and third trimesters of pregnancy, nor while breastfeeding.Geriatric Use: No INPEFA dosage change is recommended based on age. No overall differences in efficacy were detected between these patients and younger patients, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. Elderly patients may be at increased risk for volume depletion adverse reactions, including hypotension. Renal Impairment: INPEFA was evaluated in patients with chronic kidney disease (eGFR 25 to 60 mL/min/1.73 m2) and in patients with heart failure with eGFR
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