Lactulose

Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), May 25, 2026 – GENFIT (Euronext: GNFT), a biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today highlights its broad participation at EASL Congress 2026. This visibility reflects both its scientific momentum and its active involvement in the ACLF ecosystem, as well as its position at an inflection point in MASH, while also highlighting the continuous progress made in PBC, driven by its partner Ipsen. I. GENFIT Posters Seven posters have been accepted for presentation at EASL Congress mainly covering GENFIT’s key assets positioned in Acute on-Chronic Liver Failure (ACLF) and including GENFIT’s latest work on Real-World data in ACLF. ACLF – Scientific Data Poster FRI-384: G1090N - Differential activity of nitazoxanide vs rifaximin in lipopolysaccharide-induced disease models Poster FRI-383: G1090N - Effect of nitazoxanide on organ failures in disease models of alcohol-mediated ACLF Poster FRI-412: SRT-015 - Balancing immune dysfunction in ACLF: ASK1 inhibitor SRT-015 mitigates inflammatory responses while enhancing immune antibacterial defenses ACLF – Real-World Data Poster TOP-032: Real-world data highlight gaps in hospital care and access to gastroenterologists or hepatologists in patients with acutely decompensated cirrhosis Poster SAT-468: Clinical impact of bacterial infections in acutely decompensated cirrhosis: insights from 4.97 million admissions Poster SAT-478: Use and effectiveness of lactulose and rifaximin in patients with cirrhosis and hepatic encephalopathy Poster WED-499: Closing the coding gap: International Classification of Diseases (ICD)-10 code K76.82 for hepatic encephalopathy achieves rapid uptake in U.S. real world practice GENFIT did not submit data on GNS561 in cholangiocarcinoma at this stage, as dose escalation in the ongoing Phase 1 study is continuing. Given its oncology focus, this program is expected to be featured at international congresses such as ASCO1 and ESMO2. II. ACLF elevated to a strategic priority across the ecosystem As a result of GENFIT’s efforts, engagement around ACLF has strengthened, advancing understanding of key clinical and regulatory challenges and positioning ACLF as a shared strategic priority among leading stakeholders, including the Forum for Collaborative Research. This momentum is set to materialize at the following two key events at the 2026 congress. May 26, 2026: Global Consensus Meeting on Harmonizing the Definition of ACLF For the first time, EASL and its sister societies AASLD3, APASL4, ALEH5, and SOLDA6 will come together to forge a unified global definition of ACLF. This initiative aims to overcome long-standing regional differences and accelerate progress for patients worldwide. The first outcomes of this collaboration will be presented during this multistakeholder event, taking place at the Porta Fira Hotel in Barcelona, the day before the official start of EASL Congress 2026. May 27, 2026: ACLF Insights event GENFIT and EF CLIF will co‑host their annual ACLF Insights event, beginning with an update from Dr. Veronica Miller, PhD, Adjunct Professor at Berkeley Public Health and Director of the Forum for Collaborative Research (USA), and Dr. Richard Moreau, MD, Senior Scientist at INSERM and Director of the European Foundation for the Study of Chronic Liver Failure (EF CLIF). They will introduce the governance framework of the ACLF Program announced at the end of last year by the Forum for Collaborative Research and recently launched. Dr. Jonel Trebicka, MD, PhD, Head of Department and Professor of Medicine at the University of Münster (Germany), will then discuss translational science and highlight key approaches used in the field. GENFIT will close the session with an update on its programs. III. Rising importance of GENFIT’s MASH non-invasive diagnostic MASH will be a prominent area of interest at the EASL Congress, with around 250 abstracts including 4 late breakers presented in the 2026 edition, including contributions from large pharmaceutical and biotechnology companies. This momentum reflects a rapidly expanding therapeutic market, highlighted by the near-blockbuster performance of first approved treatments in their initial year, further increasing the need for scalable patient identification. While GENFIT will not be presenting data this year, its NIS2+® non-invasive diagnostic technology is already embedded in EASL–EASD–EASO guidelines. As therapies expand, addressing persistent underdiagnosis and enabling patient identification at scale becomes critical, reinforcing the strategic positioning of GENFIT’s technology. IV. New data presented by Ipsen on Iqirvo® in Primary Biliary Cholangitis (PBC) Ipsen will be presenting six new datasets during the EASL Congress, including late-breaking abstracts bringing new insights into disease management, combining real-world evidence and patient-reported outcomes to better understand both disease progression and patient experience: Poster LBP-033: Elafibranor treatment results in rapid reductions in biochemical markers and symptom burden: data from the ongoing prospective, non-interventional ELFINITY phase IV global study in patients with primary biliary cholangitis Poster LBP-018: Improvements in fatigue in patients with primary biliary cholangitis treated with elafibranor: Patient-Reported Outcome Measurement Information System Fatigue Short Form 7a (PFSF 7a) data from the phase III ELATIVE® trial Poster LBP-023: Real-world outcomes in patients with primary biliary cholangitis who initiated elafibranor treatment with baseline alkaline phosphatase less than 1.67× the upper limit of normal Poster SAT-396: Bone mineral density is stable in patients with primary biliary cholangitis receiving up to 3.5 years of elafibranor treatment Poster SAT-364: Long-term improvements in lipid profiles with elafibranor treatment, and favourable safety with concomitant statin use, in patients with primary biliary cholangitis during the open-label extension of the phase III ELATIVE® trial Poster SAT-300: Long-term treatment with elafibranor improves markers of immune response and inflammation in primary biliary cholangitis END ABOUT GENFIT GENFIT is a biopharmaceutical company committed to improving the lives of patients with rare, life-threatening liver diseases whose medical needs remain largely unmet. GENFIT is a pioneer in liver disease research and development with a rich history and a solid scientific heritage spanning more than two decades. Today, GENFIT focuses on Acute on-chronic Liver Failure (ACLF) and associated conditions such as acute decompensation (AD) and hepatic encephalopathy (HE). It develops therapeutic assets which have complementary mechanisms of action, selected to address key pathophysiological pathways. GENFIT also targets other serious diseases, such as cholangiocarcinoma (CCA), urea cycle disorders (UCD) and organic acidemia (OA). Its R&D portfolio, covering several stages of development, ensures a constant news flow. GENFIT's expertise in developing high-potential molecules – from early to advanced pre-commercialization stages – culminated in 2024 with the accelerated approval of Iqirvo® (elafibranor) by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for the treatment of Primary Biliary Cholangitis (PBC). Iqirvo® is now marketed in several countries.7 Beyond therapies, GENFIT also has a diagnostic franchise including NIS2+® for the detection of Metabolic dysfunction-associated steatohepatitis (MASH, formerly known as NASH for non-alcoholic steatohepatitis). GENFIT, a BCorp™ certified company since 2025, is headquartered in Lille, France and has offices in Paris (France), Zurich (Switzerland) and Cambridge, MA (USA). The Company is listed on the Euronext regulated market in Paris, Compartment B (Euronext: GNFT). In 2021, Ipsen became one of GENFIT's largest shareholders, acquiring an 8% stake in the Company's capital. www.genfit.com FORWARD LOOKING STATEMENTS This press release contains certain forward-looking statements with respect to GENFIT, including, but not limited to, statements regarding the Company’s participation in EASL Congress 2026, the expected scientific and strategic momentum in Acute-on-Chronic Liver Failure (ACLF), the growing importance of MASH and related diagnostic technologies, the advancement of GENFIT’s research and development programs, including in ACLF and other indications, the ongoing development of GNS561, and the potential progress and impact of elafibranor in Primary Biliary Cholangitis (PBC) by Ipsen. The use of certain words, such as "believe", "potential", "expect", “target”, “may”, “will”, "should", "could", "if" and similar expressions, is intended to identify forward-looking statements. Although the Company believes its expectations are based on the current expectations and reasonable assumptions of the Company’s management, these forward-looking statements are subject to numerous known and unknown risks and uncertainties, which could cause actual results to differ materially from those expressed in, or implied or projected by, the forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in research and development, including in relation to non-clinical and pre-clinical programs, reproducibility of preclinical results, the translation of animal model data to human biology, in relation to safety of drug candidates, cost of, progression of, and results from, our ongoing and planned clinical trials, patient recruitment, review and approvals by regulatory authorities in the United States, Europe and worldwide, of our drug and diagnostic candidates, pricing, approval and commercial success of elafibranor in the relevant jurisdictions, exchange rate fluctuations, and our continued ability to raise capital to fund our development, as well as those risks and uncertainties discussed or identified in the Company’s public filings with the AMF, including those listed in Chapter 2 "Risk Factors and Internal Control" of the Company's 2025 Universal Registration Document filed on April 3, 2026 (no. 26-0221) with the Autorité des marchés financiers ("AMF"), which is available on GENFIT's website (www.genfit.fr) and the AMF's website (www.amf.org), and those discussed in reports filed with the AMF or otherwise made public, by the Company. In addition, even if the results, performance, financial position and liquidity of the Company and the development of the industry in which it operates are consistent with such forward-looking statements, they may not be predictive of results or developments in future periods. These forward-looking statements speak only as of the date of publication of this press release. Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise. CONTACTS GENFIT | Investors Jean-Christophe Marcoux – Chief Corporate Affairs Officer | Tel: +33 3 2016 4000 | jean-christophe.marcoux@genfit.com GENFIT | Media Bruno ARABIAN – Agence Maarc | Tel : 06 87 88 47 26 | bruno.arabian@maarc.fr Stephanie Boyer – Press relations | Tel: +333 2016 4000 | stephanie.boyer@genfit.com GENFIT | 885 Avenue Eugène Avinée, 59120 Loos - FRANCE | +333 2016 4000 | www.genfit.com 1 American Society of Clinical Oncology (ASCO)2 European Society for Medical Oncology (ESMO)3 The American Association for the Study of Liver Diseases, a professional organization dedicated to advancing the science and practice of hepatology4 Asia-Pacific Association for the Study of the Liver, a regional organization supporting research and education in hepatology.5 Latin American Association for the Study of the Liver, a scientific association promoting liver research and education in Latin America.6 Society on Liver Disease in Africa, an organization promoting liver health research and education across Africa7 Elafibranor is marketed and commercialized, notably in the U.S and Europe, by Ipsen under the trademark Iqirvo® Attachment GENFIT Highlights Broad Scientific and Strategic Presence at EASL Congress 2026

Enters into Strategic Transaction, unlocking $100 million in value Sharpens focus on Orphan Drug candidates to address unmet medical needs NASHVILLE, Tenn., May 5, 2026 /PRNewswire/ -- Cumberland Pharmaceuticals Inc. (Nasdaq: CPIX), a specialty pharmaceutical company, announced today that its product portfolio of FDA-approved brands delivered combined net revenues of $9.1 million during the first quarter of 2026. Cumberland ended the quarter with $71.0 million in total assets, $49.7 million in liabilities and $21.6 million of shareholders' equity. "We entered 2026 with strong momentum following an outstanding 2025, which featured double-digit revenue growth, the addition of a new product to our portfolio, new international approvals and breakthrough clinical study results," said A.J. Kazimi, Cumberland Pharmaceuticals CEO. "We have built on that momentum through our recently announced Strategic Transaction, which represents an important next step in our Company's evolution, enabling us to sharpen our focus on developing high-value product candidates, while unlocking significant value for our shareholders." RECENT COMPANY DEVELOPMENTS INCLUDE: Strategic Transaction Cumberland recently announced a Strategic Transaction with Apotex Inc., the largest Canadian-based pharmaceutical company, to integrate the branded U.S. commercial businesses. Under the terms of the agreement, Apotex will acquire Cumberland's portfolio of FDA-approved brands for $100 million in cash consideration, subject to Cumberland shareholders' approval and certain other customary closing conditions. This transaction is designed to unlock value and sharpen Cumberland's focus on advancing its pipeline of differentiated product candidates designed to address unmet medical needs. The integration of Cumberland's products will create more critical mass to support patient care and expand product distribution. Following the closing of the transaction, Cumberland will retain its development programs, as well as its majority ownership in Cumberland Emerging Technologies. This positions Cumberland to operate with the profile of an innovative, development-stage biopharmaceutical organization devoted to new medicines for the future. Development Pipeline In addition to its portfolio of FDA-approved brands involved in the transaction with Apotex, Cumberland is developing ifetroban, a potent thromboxane antagonist, through a series of clinical programs designed to address unmet medical needs with significant market potential. Cumberland has announced breakthrough results in a Phase II clinical study of ifetroban in patients with cardiomyopathy associated with Duchenne muscular dystrophy ("DMD"). This rare, fatal genetic neuromuscular disease results in deterioration of the skeletal, heart and lung muscles. Discussions with the FDA are underway regarding the study results and remaining requirements for approval. During the first quarter of 2026, the FDA granted Fast Track Designation for Cumberland's ifetroban candidate product for DMD patients. This designation is intended to accelerate the development and review of therapies that address serious conditions with unmet medical needs. Importantly, it allows for more frequent FDA interaction, rolling data submissions and earlier guidance throughout the approval process. The program previously received both Orphan Drug and Rare Pediatric Disease designations from the FDA. In addition, Cumberland has a Phase II clinical program evaluating its ifetroban product candidate in patients with Systemic Sclerosis ("SSc") or scleroderma, a debilitating autoimmune disorder characterized by diffuse fibrosis of the skin and internal organs. Enrollment in the study is completed and the next milestone will be announcing its top-line study results. Cumberland's third development program involves the use of ifetroban in patients with Idiopathic Pulmonary Fibrosis ("IPF"), the most common form of progressive fibrosing interstitial lung disease. Enrollment in the study is well underway at medical centers across the U.S., with interim safety and interim efficacy results pending. FINANCIAL RESULTS: Net Revenue: For first quarter of 2026, the Company's net revenues of $9.1 million, which represented a 5% increase compared to the first quarter of 2025 after removing the $3 million milestone payment last year associated with the approval of Vibativ® in China. Cumberland's branded portfolio revenue included $1.0 million for Kristalose®, $2.9 million for Sancuso®, $2.1 million for Vibativ®, $1.0 million for Caldolor® and $1.9 million for Talicia.® Operating Expenses: Total operating expenses for the quarter were $12.3 million. Net Income (Loss): The net loss for the first quarter of 2026 was approximately $3.3 million. Adjusted Earnings (Loss): Adjusted loss for the quarter was $1.9 million, or $0.13 per share. Balance Sheet: At March 31, 2026, Cumberland had approximately $71.0 million in total assets, including $11.0 million in cash and cash equivalents. Liabilities totaled $49.7 million, including $5.2 million on the company's credit facility. Total shareholders' equity was $21.6 million on March 31, 2026. EARNINGS REPORT CALL: A conference call will be held today, May 5, 2026, at 4:30 p.m. Eastern Time to provide a company update and discuss the financial results. The link to register is . Registered participants can dial in from their phone using a dial-in and PIN number that will be provided to them. Alternatively, they can choose a "Call Me" option to have the system automatically call them at the start of the conference. A replay of the call will be available for one year and can be accessed via Cumberland's website or by visiting: . ABOUT CUMBERLAND PHARMACEUTICALS: Cumberland Pharmaceuticals Inc. is the largest biopharmaceutical company founded and headquartered in Tennessee and is focused on providing unique products that improve the quality of patient care. The company develops, acquires, and commercializes products for the hospital acute care, gastroenterology and oncology market segments. The company's portfolio of FDA-approved brands includes: Acetadote ® (acetylcysteine) injection, for the treatment of acetaminophen poisoning; Caldolor ® (ibuprofen) injection, for the treatment of pain and fever; Kristalose ® (lactulose) oral, a prescription laxative, for the treatment of constipation; Sancuso ® (granisetron) transdermal, for the prevention of nausea and vomiting in patients receiving certain types of chemotherapy treatment; Vaprisol ® (conivaptan) injection, to raise serum sodium levels in hospitalized patients with euvolemic and hypervolemic hyponatremia; Vibativ ® (telavancin) injection, for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia, as well as complicated skin and skin structure infections; and Talicia ® (omeprazole, amoxicillin and rifabutin) oral capsule, for the treatment of H. pylori infection. The company also has a series of Phase II clinical programs underway evaluating its ifetroban product candidate in patients with Duchenne Muscular Dystrophy, Systemic Sclerosis and Pulmonary Fibrosis. For more information on Cumberland's approved products, including full prescribing information, please visit the links to the individual product websites, which can be found on the company's website at . About Acetadote ® (acetylcysteine) Injection Acetadote, administered intravenously within 8 to 10 hours after ingestion of a potentially hepatotoxic quantity of acetaminophen, is indicated to prevent or lessen hepatic injury. Used in the emergency department, Acetadote is approved in the United States to treat overdose of acetaminophen, a common ingredient in many over-the-counter medications. Acetadote is contraindicated in patients with hypersensitivity or previous anaphylactoid reactions to acetylcysteine or any components of the preparation. For full prescribing and safety information, visit . About Caldolor ® (ibuprofen) Injection Caldolor is indicated in adults and pediatric patients for the management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics, as well as the reduction of fever. It was the first FDA-approved intravenous therapy for fever. Caldolor is contraindicated in patients with known hypersensitivity to ibuprofen or other non-steroidal anti-inflammatory drugs (NSAIDs) as well as patients with a history of asthma or other allergic type reactions after taking aspirin or other NSAIDs. Caldolor is contraindicated for use during the peri-operative period in the setting of coronary artery bypass graft (CABG) surgery. For full prescribing and safety information, including boxed warning, visit . About Kristalose ® (lactulose) Oral Solution Kristalose is indicated for the treatment of acute and chronic constipation. It is a unique, proprietary, crystalline form of lactulose, with no restrictions on length of therapy or patient age. Kristalose is contraindicated in patients who require a low-galactose diet. Elderly, debilitated patients who receive lactulose for more than six months should have serum electrolytes (potassium, chloride, carbon dioxide) measured periodically. For full prescribing and safety information, visit . About Sancuso ® ( granisetron) Transdermal System Sancuso is the only skin patch approved by the FDA for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately and/or highly emetogenic chemotherapy. When applied 24 to 48 hours before receiving chemotherapy, the Sancuso patch slowly and continuously releases the medicine contained in the adhesive through clean and intact skin areas into the patient's bloodstream. It can prevent CINV for chemotherapy regimens of up to five consecutive days. For full prescribing and safety information, visit . About Vaprisol ® (conivaptan hydrochloride) Injection Vaprisol is an intravenous treatment for hyponatremia used in the critical care setting. Hyponatremia is an electrolyte disturbance in which sodium ion concentration in blood plasma is lower than normal. This can be associated with a variety of critical care conditions including congestive heart failure, liver failure, kidney failure and pneumonia. The product is a vasopressin receptor antagonist that raises serum sodium levels and promotes free water secretion. Vaprisol is contraindicated in patients with hypovolemic hyponatremia. The coadministration of Vaprisol with potent CYP3A inhibitors, such as ketoconazole, itraconazole, clarithromycin, ritonavir and indinavir, is contraindicated. For full prescribing and safety information, including boxed warning, visit . About Vibativ ® (telavancin) for Injection Vibativ is a patented, FDA-approved injectable anti-infective for the treatment of certain serious bacterial infections including hospital-acquired and ventilator-associated bacterial pneumonia and complicated skin and skin structure infections. It addresses a range of Gram-positive bacterial pathogens, including those that are considered difficult-to-treat and multidrug-resistant. Intravenous unfractionated heparin sodium is contraindicated with Vibativ administration due to artificially prolonged activated partial thromboplastin time (aPTT) test results for up to 18 hours after Vibativ administration. Vibativ is contraindicated in patients with a known hypersensitivity to telavancin. For more information, please visit . About Talicia ® Talicia® is an FDA approved oral capsule for the treatment of Helicobacter pylori (H. pylori) infection in adults, a bacterial infection of the stomach and leading risk factor for gastric cancer. Talicia is listed as a first line option in the 2024 ACG Guideline for the treatment of H. pylori and features three key advantages: 1) high eradication rates - >90% in confirmed adherent patients, 2) the simplicity of an all-in-one capsule, and 3) low resistance to the two antibiotics - amoxicillin and rifabutin. For more information, please visit . FORWARD LOOKING STATEMENTS: This press release contains forward-looking statements, which are subject to certain risks and reflect Cumberland's current views on future events based on what it believes are reasonable assumptions. No assurance can be given that these events will occur. Forward-looking statements include, among other things, statements regarding the Company's intent, belief or expectations, and can be identified by the use of terminology such as "may," "will," "expect," "believe," "intend," "plan," "estimate," "goal", "should," "seek," "anticipate," "look forward" and other comparable terms or the negative thereof. As with any business, all phases of Cumberland's operations are subject to factors outside of its control, and any one or combination of these factors could materially affect Cumberland's operation results. These factors include risks and uncertainties related to the strategic transaction, risks related to our ability to develop our pipeline of new product candidates, macroeconomic conditions, including changes in interest rates, inflation, tariffs, competition, an inability of manufacturers to produce Cumberland's products on a timely basis, failure of manufacturers to comply with regulations applicable to pharmaceutical manufacturers, natural disasters, public health epidemics, maintaining an effective sales and marketing infrastructure, and other events beyond the Company's control as more fully discussed in its most recent annual report on Form 10-K as filed with the U.S. Securities and Exchange Commission ("SEC"), as well as the Company's other filings with the SEC from time to time. There can be no assurance that results anticipated by the company will be realized or that they will have the expected effects. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date hereof. The Company does not undertake any obligation to publicly revise these statements to reflect events after the date hereof. The Company provided the above adjusted supplemental financial performance measures, which are considered "non-GAAP" financial measures under applicable SEC rules and regulations. These financial measures should be considered supplemental to, and not as a substitute for, financial information prepared in accordance with Generally Accepted Accounting Principles ("GAAP"). The definition of these supplemental measures may differ from similarly titled measures used by others. Because these supplemental financial measures exclude the effect of items that will increase or decrease the Company's reported results of operations, management encourages investors to review the Company's consolidated financial statements and publicly filed reports in their entirety. A reconciliation of the supplemental financial measures to the most directly comparable GAAP financial measures is included in the tables accompanying this release. Cumberland's management believes these supplemental financial performance measures are important as they are used by management, along with financial measures in accordance with GAAP, to evaluate the Company's operating performance. In addition, Cumberland believes that they will be used by certain investors to measure the Company's operating results. Management believes that presenting these supplemental measures provides useful information about the Company's underlying performance across reporting periods on a consistent basis by excluding items that Cumberland does not believe are indicative of its core business performance or reflect long-term strategic activities. Certain of these items are not settled through cash payments and include: depreciation, amortization of intangible and right-of-use assets, share-based compensation expense and income taxes. Cumberland utilizes its net operating loss carryforwards to pay minimal income taxes. In addition, the use of these financial measures provides greater transparency to investors of supplemental information used by management in its financial and operational decision-making, including the evaluation of the Company's operating performance. The Company defines these supplemental financial measures as follows: Adjusted Earnings (loss): Net income (loss) adjusted for the impact of income taxes, depreciation and amortization expense, share-based compensation, interest income and interest expense. (a) Represents the share-based compensation of Cumberland. (b) Represents the straight line reduction in carrying value of right-of-use assets. Adjusted Diluted Earnings (loss) Per Share: Adjusted Earnings (loss) divided by diluted weighted-average common shares outstanding. SOURCE Cumberland Pharmaceuticals Inc. 21% more press release views with Request a Demo