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Commercial launch of INPEFA® (sotagliflozin) continues to progress. with increasing demand across the cardiology community and improving payer access Patient enrollment underway in PROGRESS, a Phase 2b study of LX9211 in Diabetic Peripheral Neuropathic Pain; topline data anticipated Q2 2025 Preparations underway for Phase 3 study of sotagliflozin in Hypertrophic Cardiomyopathy and resubmission of NDA for sotagliflozin in Type 1 Diabetes Recent Successful Capital Raise Supports Company Initiatives for Growth and Expansion Company to Present at the Leerink Partners Global Biopharma Conference Tuesday, March 12th at 3:40 p.m. ET THE WOODLANDS, Texas, March 11, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported financial results for the three months ended December 31, 2023 and provided an update on key corporate milestones. “2023 was a pivotal year for Lexicon,” said Lonnel Coats, Lexicon’s chief executive officer. “We launched INPEFA within weeks of receiving U.S. FDA approval with a broad label for heart failure, while in parallel continuing the advancement of our innovative research and development pipeline.” “In the fourth quarter, we saw continued progress on the launch of INPEFA and began to see increased prescriber demand and important formulary wins, which we expect to accelerate in the first half of 2024. We advanced LX9211 into late-stage development for diabetic peripheral neuropathic pain (DPNP), with the potential to become the first new, non-opioid drug approved for neuropathic pain in over two decades.” “We are preparing for Phase 3 development of sotagliflozin in hypertrophic cardiomyopathy (HCM), an area of high unmet need with very few treatments in development. And following recent feedback from FDA, we are preparing to resubmit our New Drug Application (NDA) for sotagliflozin as an adjunct to insulin therapy in patients with type 1 diabetes and chronic kidney disease. Our research and development engine also continues to produce, and we are conducting preclinical development on an oral small molecule compound for obesity and weight management. With these opportunities and the support from shareholders in our recent successful financing, Lexicon is well positioned for growth and expansion in 2024 and beyond.” Fourth Quarter Highlights INPEFA® (sotagliflozin) Launch Progress INPEFA was placed on the formularies of multiple important Medicare and commercial plans during the fourth quarter, including Express Scripts’ Premier Access and Premier Performance national formularies for Medicare patients and Basic and High Performance formularies for commercially insured patients. Publications and Data On October 4, Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer, conducted an oral presentation entitled Temporal shift in heart failure medications prescribed to hospitalised patients with and without diabetes in a large US integrated health system at the 59th Annual Meeting of European Association for the Study of Diabetes (EASD) in Hamburg, Germany and online. On October 8, Michael J. Davies, Ph.D., Lexicon’s executive director of clinical development, presented a new analysis of clinical trial data for sotagliflozin entitled Sotagliflozin Reduces the Risk of Cardiovascular Events In Patients With Left Ventricular Hypertrophy Without Hypertension: A Post Hoc Analysis From SCORED at the Heart Failure Society of America (HFSA) Annual Scientific Meeting in Cleveland, Ohio. On November 12, 2023, Lexicon had a significant presence and conducted multiple presentations related to INPEFA at the American Heart Association Scientific Sessions 2023, including one oral presentation highlighting the early clinical benefit of INPEFA for heart failure and atherosclerotic events and another focusing on cost-effectiveness metrics associated with the use of INPEFA. LX9211 In December, patient enrollment began in the PROGRESS Phase 2b dose optimization study and is progressing well. The PROGRESS study marks initiation of the late-stage development program for AAK1 inhibitor LX9211, with potential to become the first new, non-opioid drug therapy approved in neuropathic pain in more than 20 years. Topline data from the PROGRESS study is anticipated in 2Q 2025. Data relating to LX9211 were shared at various global congresses during the fourth quarter, including the 33rd Annual Meeting of the Diabetic Neuropathy Study Group (NeuroDiab), held September 28-October 1 in Thessaloniki, Greece; the 59th Annual Meeting of the European Association for the Study of Diabetes (EASD), held October 2-6 in Hamburg, Germany and online; the 17th Annual Pain Therapeutics Summit (Arrowhead Conference), held October 19-20 in San Diego, California; and the 2nd World Brain Disorders and Neuroscience Summit (BDNS), held November 9-11 in Singapore and online. Additional Pipeline Opportunities Preparations are underway for Phase 3 development of sotagliflozin in HCM. Following recent feedback from FDA, preparations are underway to resubmit Lexicon’s NDA for sotagliflozin as an adjunct to insulin therapy in patients with type 1 diabetes and chronic kidney disease. As part of Lexicon’s ongoing discovery efforts, the company is advancing preclinical development of a novel oral compound for obesity and weight management. Fourth Quarter 2023 Financial Highlights Unless otherwise stated, all comparisons are for the fourth quarter and full year of 2023 compared to the fourth quarter and full year of 2022. Revenues: Revenues for the fourth quarter and full year of 2023 were $0.7 million and $1.2 million, respectively, primarily from the commercialization of INPEFA. Research and Development (R&D) Expenses: Research and development expenses for the fourth quarter of 2023 increased to $14.8 million from $14.0 million for the corresponding period in 2022. Full-year research and development expenses increased to $58.9 million in 2023 from $52.8 million for the corresponding period in 2022, primarily due to higher manufacturing costs, partially offset by lower professional and consulting fees related to the prior year NDA resubmission for heart failure. Selling, General and Administrative (SG&A) Expenses: Selling, general and administrative expenses for the fourth quarter of 2023 increased to $32.6 million from $16.3 million in 2022 and for the full-year 2023 increased to $114.0 million from $48.1 million in 2022. The increase in 2023 is primarily due to the significant investment in the commercial launch of INPEFA, including higher salaries and benefits of the new sales force and other increased headcount, higher travel, and higher marketing costs. Net Loss: Net loss for the fourth quarter of 2023 was $48.2 million, or $0.20 per share, as compared to a net loss of $30.5 million, or $0.16 per share, in the corresponding period in 2022. For the fourth quarters of 2023 and 2022, net loss included non-cash, stock-based compensation expense of $3.2 million and $3.3 million, respectively. Net loss for the full year was $175.6 million, or $0.79 per share, in 2023 as compared to a net loss of $101.9 million, or $0.62 per share, in the corresponding period in 2022. For the full years of 2023 and 2022, net loss included non-cash, stock-based compensation expense of $14.3 million and $11.5 million, respectively. Cash and Investments: As of December 31, 2023, Lexicon had $170.0 million in cash and investments, as compared to $138.4 million as of December 31, 2022. Lexicon 2024 Investor Day – April 22, 2024 In lieu of a year-end earnings conference call, Lexicon plans to hold an Investor Day on April 22, 2024. The event will be webcast live on Lexicon’s website at . The agenda will include a business and regulatory update, with participation from multiple physician experts in the areas of cardiometabolic disorders, HCM, type 1 diabetes and diabetic peripheral neuropathic pain. For Lexicon’s latest investor presentation, please visit . Planned Participation in Upcoming Investor Conferences: Leerink Partners Global Biopharma Conference March 12 Needham 23rd Annual Virtual Healthcare Conference on April 8-11 Piper Sandler Virtual Cardiovascular Day on April 10 Piper Sandler Spring Biopharma Symposium on April 16-17 These events will be webcast live on Lexicon’s website at . 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 < 60 mL/min/1.73 m2. The safety pro INPEFA across eGFR subgroups in these studies was consistent with the known safety profile. There was an increase in volume-related adverse events (e.g., hypotension, dizziness) in patients with eGFR < 30 mL/min/1.73m2 relative to the overall safety population. Efficacy and safety studies with INPEFA did not enroll patients with an eGFR less than 25 mL/min/1.73 m2 or on dialysis. After starting therapy in the studies, patients were discontinued if eGFR fell below 15 mL/min/1.73 m2 or were initiated on chronic dialysis. Hepatic Impairment: INPEFA is not recommended in patients with moderate or severe hepatic impairment. Click here for full Prescribing Information. 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 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 . 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, 2022, 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, Years Ended December 31, (In thousands, except per share data) 2023 2022 2023 2022 (Unaudited) (Unaudited) Revenues: Net product revenue $ 672 $ - $ 1,110 $ - Royalties and other revenue 30 28 94 139 Total revenues 702 28 1,204 139 Operating expenses: Cost of sales 70 - 85 - Research and development, including stock-based compensation of $1,297, $1,184, $5,139 and $4,253, respectively 14,762 13,977 58,887 52,816 Selling, general and administrative, including stock-based compensation of $1,915, $2,084, $9,201, and $7,267, respectively 32,607 16,329 113,982 48,083 Total operating expenses 47,439 30,306 172,954 100,899 Loss from operations (46,737 ) (30,278 ) (171,750 ) (100,760 ) Interest expense (3,909 ) (1,103 ) (11,589 ) (2,780 ) Interest and other income, net 2,402 887 7,732 1,596 Net loss $ (48,244 ) $ (30,494 ) $ (175,607 ) $ (101,944 ) Net loss per common share, basic and diluted $ (0.20 ) $ (0.16 ) $ (0.79 ) $ (0.62 ) Shares used in computing net loss per common share, basic and diluted 244,925 188,726 221,130 165,733 As of As of Consolidated Balance Sheet Data December 31, 2023 December 31, 2022 (In thousands) Cash and investments $ 170,026 $ 138,357 Property and equipment, net 1,987 2,071 Goodwill 44,543 44,543 Total assets 229,429 194,299 Long-term debt, net 99,508 48,579 Accumulated deficit (1,765,327 ) (1,589,720 ) Total stockholders' equity 94,622 117,124 For Investor Inquiries: Lisa DeFrancesco Lexicon Pharmaceuticals, Inc. lexinvest@lexpharma.com For Media Inquiries: Alina Cocuzza Lexicon Pharmaceuticals, Inc. acocuzza@lexpharma.com

TAICHUNG, Feb. 24, 2024 /PRNewswire/ -- In winter, cardiovascular diseases are more prevalent, which significantly increase the likelihood of arterial blockage. In addition to increasing the possibility of accompanying myocardial infarction or stroke, seniors should be especially cautious about Peripheral Arterial Occlusive Disease (PAOD). In mild cases, impaired walking, numbness and weakness during running are experienced; in cases of severe blockage, patients are at risk of developing gangrene (a dry, black sore) and frequently have their foot amputated eventually. If the event comes quickly - so called acute PAOD, even after receiving standard treatment, the mortality and amputation rates remain in the 20-30% range. Continue Reading Chang, a 72-year-old female, (first from the right) has a history of hypertension, coronary artery occlusion, hyperthyroidism, and paroxysmal atrial fibrillation, as well as right lower extremity coldness with unusual pain. Dr. Hsu Chung-Ho (middle) examined thrombi in the popliteal artery of her right lower extremity, resulting in severe obstruction of blood flow in the lower extremity. Since 2016, China Medical University Hospital (CMUH) in Taiwan has established the "24-hour thrombolysis team" to conduct research and treatment in response to this deadly disease. For acute PAOD patients, after emergent survey at Emergency Room (ER), Pharmacomechanical Thrombectomy (PMT) with Rotarex based atherectomy with or without Ekosonic Endovascular System (EKOS) are performed to treat patients with acute and severe arterial blockage in the lower extremities if indicated. The clinical amputation and mortality rates in regard of acute PAOD significantly reduced from 20-30% to 3%. The clinical results were published in the medical journal "International Angiology." "To prevent permanent necrosis of the muscle tissues and to lower mortality, a 24-hour standby medical team must be available to perform emergent thrombi removal within 'golden' hours before irreversible events develop." says Dr. Chung-Ho Hsu, director of the section of peripheral vascular disease, division of cardiovascular medicine, department of internal medicine, CMUH, Taiwan. Miss Chang, a 72-year-old female, has a history of hypertension, coronary artery occlusion, hyperthyroidism, and paroxysmal atrial fibrillation. In spite of this, Chang experienced right lower extremity coldness with unusual pain suddenly. Following an ultrasound examination by Dr. Hsu, thrombi were discovered in the right popliteal artery, resulting in severe obstruction of blood flow in the lower extremity. CMUH convened the "24-hour thrombolysis team", where an emergent catheter-based thrombectomy/thrombolysis operation was performed under local anesthesia immediately. After PMT with Rotarex and thrombolysis with EKOS, Chang's blood circulation was greatly improved, and the amputation crisis was successfully averted. Mr. Kou is another case of successful lower limb salvage treatment. Mr. Kuo is an 80-year-old patient with multiple chronic conditions: hypertension, diabetes, coronary artery occlusion, persistent atrial fibrillation, and heart failure, as well as chronic obstructive pulmonary disease. Mr.Kuo rushed to the ER in CMUH after experiencing right lower extremity coldness and sharp pain. Dr. Hsu discovered thrombi in the anterior tibial artery of Mr.Kuo's right lower extremity during an examination, resulting in poor blood circulation in the lower extremities. The thrombi were successfully removed after an emergent catheter-based thrombolysis with EKOS, as well as the use of drug-coated balloons and stents, and blood flow returned to normal, avoiding the fate of an amputation that could have resulted in severe disability. Acute PAOD is frequently the result of atrial fibrillation, which causes thrombi to fall from the heart to the arteries of the lower extremities, resulting in a sudden and severe blockage. According to Director Hsu at CMUH, acute PAOD is most prevalent in the lower extremities, and symptoms include decreased temperature of the affected limb (frequently feeling cold), pain, pallor, numbness, poor walking ability, pulselessness, and paralysis. In the most severe cases of acute PAOD, muscle tissues develop ischemic necrosis, and patients are even forced to have limbs amputated or lost their life. Mortality will be as high as 100 percent if left untreated. Importantly, after amputation, these patients are likely to face life-threatening risks again, and condition will deteriorate due to less exercise after amputation, making this disease difficult to treat. As for how to determine if one has PAOD, Dr. Hsu explains that the disease can be divided into four stages based on its severity and clinical manifestations (Fontaine stage): Stage 1 (asymptomatic): No symptoms, only diseased lower limb arteries identified. Stage 2: The legs are prone to fatigue and weakness during walking, but the patient can continue to walk after a short rest. The recurrence of the initial symptoms appears later on, which is given the name intermittent claudication. Stage 3: Severe vascular obstruction and inadequate local circulation while at rest, which results in chronic pain,so called ischemic rest pain. Stage 4: Ulcers and necrosis begin in the toes and spread to the feet and ankles as the skin changes color from pink to dark purple as a result of ischemia. However, if the symptoms worsen quickly with either pain, pallor, poikilothermia, paresthesia, pulselessness, or paralysis, one should think about acute PAOD, which is a medical emergency and need to rush to the ER immediately. For acute PAOD, CMUH will arrange vascular ultrasound immediately at ER and decide which is the clinical stage. If the condition is feasible, 24-hour thrombolysis team will be initiated to perform endovascular therapy immediately to save legs, also save lives. Acute PAOD often stems from atrial fibrillation, a condition that leads to the formation of thrombi in the heart which can then dislodge and block the arteries in the lower extremities, causing sudden and severe blockage. In light of this, Director Hsu strongly advises patients with atrial fibrillation to adhere to a regular regimen of anticoagulants to prevent thrombotic events. CMUH successfully r educed clinical amputation rates from 30% to 3%, and death rates from 30% to 3%. The clinical results were published in the medical journal "International Angiology" in April of 2022. Under the care of the "24-hour thrombolysis team" led by Director Hsu, their health and mobility have been restored. Media contact: Carolyn Chen, [email protected].tw SOURCE China Medical University Hospital

Commitment to make life-saving products to treat life-threatening hypovolemia due to sepsis and blood loss available in Sub-Saharan Africa where there is outsized demand. Targeted $20M Series B Round to include Sub-Saharan Africa in product development. Partnering with Propelevate to drive Sub-Saharan Africa strategy. KANSAS CITY, Mo., Feb. 22, 2024 /PRNewswire/ -- Life sciences company Vivacelle Bio today announced Sub-Saharan Africa as a priority region for its life-saving alternative to fluid resuscitation to treat hypovolemia caused by severe sepsis, septic shock, or blood loss. Vivacelle Bio's lifesaving cardiovascular support fluids (VBI-S and VBI-1), both comprised of phospholipid nanoparticles, can be used to treat the refractory hypovolemia and hypotension that occur in severe sepsis and septic shock, and used instead of blood to correct hypovolemia from blood loss such as after major vehicle collisions and postpartum hemorrhage. Vivacelle Bio is partnering with Propelevate to drive the Sub-Saharan Africa strategy, which is fully integrated into its Series B financing round. Globally, sepsis kills ~11M people each year. Young children in Sub-Saharan Africa have outsized rates of sepsis death from neonatal sepsis, and sepsis caused by respiratory infection, diarrheal disease, and malaria. A child born in sub-Saharan Africa is nearly 8 times more likely to die in the first month of life than a child born in the US. Likewise, seventy percent of pregnancy-related deaths globally occur in Sub-Saharan Africa. Annually more than 75,000 women in the region die from postpartum hemorrhage or maternal sepsis. Vivacelle Bio's use of phospholipid nanoparticles to raise the blood pressure in patients with life-threatening hypovolemia due to blood loss, sepsis and septic shock is unprecedented. A successful phase 2a clinical trial of VBI-S, the formulation designed for treating hypovolemia due to septic shock, was recently completed. The fluid restores intravascular volume and absorbs nitric oxide, a gas made by the body that is largely responsible for the drop in blood pressure that is not responsive to current therapy. The evidence from the clinical trial showed that VBI-S is safe for patients while it increases blood pressure and reverses organ failure even when standard therapy has failed. This is the first-time in 20 years that a phase 2 or phase 3 trial in septic shock has succeeded in meeting all of its efficacy endpoints. VBI-1, designed for blood loss, also absorbs nitric oxide, and protects vital organs from reperfusion injury. Pre-clinical studies show that VBI-1 has greater efficacy than blood or standard of care fluids in raising blood pressure after severe hemorrhagic shock. Blood and other fluids promote reperfusion injury to vital organs while VBI-1 prevents this organ damage. The current $20M Series B round includes funding for a Global Pediatric Phase III trial for VBI-S, and two Phase IIA trials for VBI-1, which will integrate sites in Sub-Saharan Africa to ensure the efficacy of both products in diverse contexts. Vivacelle Bio Co-Founder Dr. Cuthbert Simpkins, MD, Chief Innovation Officer of Vivacelle Bio and Sosland Missouri Endowed Chair in Trauma Services at the University of Missouri, Kansas City (UMKC) School of Medicine, says "VBI-S and VBI-1 can be used in any context where there is a health worker able to administer IV fluids. VBI-S has shown to be more effective than vasopressors at addressing septic shock, without the side effects such as gangrene of fingers and toes. Moreover, VBI-S carries oxygen and is shown to improve lung oxygenation, and reverse elevated creatinine in septic patients. Both VBI-S and VBI-1 are shelf stable for at least a year at room temperature with VBI-S currently having more than 2 years stability at room temperature. VBI-1 circumvents many of the challenges of blood transfusions: the challenges of securing blood donors, the need to type, to maintain cold chain, the short shelf-life, and the risk of disease transmission." Harven DeShield, JD, PhD, the CEO of Vivacelle Bio commented, "Being born in Liberia, and raised in Liberia, Côte d'Ivoire and Tanzania, the critical value proposition of VBI-S and VBI-1 being readily affordable and available in Africa is not only of immense personal importance, but also provides a holistic, strategic vehicle to address persistent health inequities in Africa related to treatment of shock and trauma." Dr. Angela James, Senior Advisor for 2Flo Ventures, a Chicago-based startup studio and venture capital firm, and investor in Vivacelle Bio, echoed the importance of the impact of addressing the global unmet need for people with sepsis and septic shock having equitable access to safe and effective treatments. "Vivacelle Bio is poised to bring life-changing drugs to patients and their families in a region which has not been given equitable access to effective therapies is a great opportunity from both a healthcare and business perspective." Through partnership with Propelevate, Vivacelle Bio will engage global health funders and stakeholders during final stages of product development, and Propelevate will drive Vivacelle Bio's go-to-market strategy for African markets upon regulatory approval. "We are excited to partner with Vivacelle Bio because of their commitment to Sub-Saharan Africa. Life sciences companies typically think about the region as an afterthought. Vivacelle Bio is already taking specific needs in the region into account in product development and laying the groundwork for eventual local manufacturing to ensure wide availability of its life-saving products," said Propelevate's Managing Director Krisila Benson. This work was supported by the Naval Medical Research Command (NMRC) - Naval Advanced Medical Development (NAMD) Program under MTEC award 20-02-NavyMultiTopic-002. About MTEC The Medical Technology Enterprise Consortium (MTEC) is a 501(c)(3) biomedical technology consortium collaborating under an Other Transaction Agreement (OTA) with the U.S. Army Medical Research and Development Command (USAMRDC) that serves those who serve our nation. For more information about MTEC, visit mtec-sc.org. About Vivacelle Bio: Vivacelle Bio () is a life sciences company that utilizes patented phospholipid nanoparticle technology to design products that increase the survivability of critically-ill patients. In addition to VBI-S and VBI-1, Vivacelle Bio has a pipeline of products at various stages of development applicable to a range of health areas including reperfusion injury, organ preservation and transplantation, multiple organ dysfunction syndrome and hyperprocalcitonemia. Vivacelle Bio has raised approximately $10.9M in seed and Series A1-A3 funding, including from the US Department of Defense, the US National Institutes of Health, and 2Flo Ventures. About Propelevate: Propelevate () is a consulting firm working at the intersection of the private sector and social impact. Propelevate has experience bringing new health products to market in Africa and Asia, raising tens of millions of dollars in global health financing, and brokering successful partnerships between commercial and development actors. SOURCE Vivacelle Bio