Peptic Ulcer

10-minute test enables detection of Helicobacter pylori, a leading cause of peptic ulcers, dyspepsia, and gastric cancerApproximately 80% of gastric cancer cases are linked to H. pylori infection; WHO classifies H. pylori as a Class 1 carcinogenThis test empowers healthcare providers with fast, accessible testing across the UAE IRVINE, Calif., April 23, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced diagnostic solutions, announced today that its Fortel® Ulcer Test has been approved for sale by the United Arab Emirates (UAE) Ministry of Health and Prevention. This regulatory approval enables Biomerica to introduce its rapid point-of-care test for Helicobacter pylori (H. pylori) infection across the UAE—a region where gastrointestinal diseases are a growing public health concern. The Fortel® Ulcer Test is a simple, quick and user-friendly diagnostic tool that detects antibodies to H. pylori, a bacterium known to cause peptic ulcer disease, dyspepsia, and gastric cancer. The test delivers accurate results in just 10 minutes. A Major Global and Regional Health Threat H. pylori infects approximately 35% of the U.S. population and 45% of the population in the five largest European countries. In the UAE, local studies estimate infection rates exceeding 50%, especially among certain age and ethnic groups. Alarmingly, 15–20% of infected individuals develop complications such as peptic ulcers, chronic digestive symptoms, or even gastric cancer. Gastric Cancer: A Deadly Consequence of H. pylori Infection Gastric cancer is the 3rd most common cause of cancer-related death globally, and approximately 80% of these cases are attributed to H. pylori infection. In recognition of its danger, the World Health Organization (WHO) designated H. pylori as one of the top 16 antibiotic-resistant bacteria that pose the greatest threat to human health and classified it as a Class 1 carcinogen. “The Fortel® Ulcer Test empowers healthcare providers to rapidly detect H. pylori infection and take timely action to prevent serious gastrointestinal diseases, including cancer,” said Zack Irani, CEO of Biomerica. “We’re proud to support the UAE’s health system with this important tool for earlier detection and better outcomes.” Strengthening Biomerica’s Regional Impact This approval further expands Biomerica’s growing footprint in the Middle East, following successful regional launches of the EZ Detect™ Colon Disease Test and other diagnostic products. The Company is collaborating with UAE-based distributors and healthcare providers to make the Fortel® Ulcer Test available throughout the country. Focused on Early Detection and Better Health Outcomes Biomerica is committed to delivering affordable, innovative diagnostic tools that improve patient outcomes through early disease detection. The Fortel® Ulcer Test represents an easy to implement solution in the fight against H. pylori-related illnesses and reflects the company’s mission to improve global health with fast, accessible diagnostics. About Biomerica (NASDAQ: BMRA) Biomerica, Inc. (www.biomerica.com) is a global biomedical technology company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products used at the point-of-care (in home and in physicians' offices) and in hospital/clinical laboratories for detection and/or treatment of medical conditions and diseases. The Company's products are designed to enhance the health and well-being of people, while reducing total healthcare costs. Biomerica primarily focuses on gastrointestinal and inflammatory diseases where the Company has multiple diagnostic and therapeutic products in development. The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain information included in this press release (as well as information included in oral statements or other written statements made or to be made by Biomerica) contains statements that are forward-looking, such as statements relating to the Company’s current and future sales, revenues, overhead, expenses, cost of goods, operations and earnings, efficacy of the Company’s products and tests including the Fortel® Ulcer Test, FDA and/or international regulatory authorization for the Company’s products to be marketed and sold, including the Fortel® Ulcer Test, and the Company’s other current and future products, the possible expansion in to other markets, uniqueness of the Company’s products, accuracy of the Company’s tests and products, pricing of the Company’s test kits, domestic and/or international market adoption and acceptance and demand for the Company’s products including the Fortel® Ulcer Test, future use of the Company's products by physicians to treat their patients, potential revenues from the sale of current or future products. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results, in the future, including, without limitation: earnings and other financial results; results of studies testing the efficacy of the Company’s inFoods tests and other products; regulatory approvals necessary prior to commercialization of the Company’s products; availability of the Company’s test kits and other products; capacity, shipping logistics, resource and other constraints on our suppliers; dependence on our third party manufacturers; dependence on international shipping carriers; governmental import/export regulations; demand for our various tests and other products; competition from other similar products and from competitors that have significantly more financial and other resources available to them; governmental virus control regulations that make it difficult or impossible for the company to maintain current operations; regulatory compliance and oversite, and the Company’s ability to obtain patent protection on any aspects of its diagnostic or therapeutic technologies. Accordingly, such results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. Additionally, potential risks and uncertainties include, among others, fluctuations in the Company's operating results due to its business model and expansion plans, downturns in international and or national economies, the Company's ability to raise additional capital, the competitive environment in which the Company will be competing, and the Company's dependence on strategic relationships. The Company is under no obligation to update any forward-looking statements after the date of this release. Corporate Contact: Zack Irani | CEOp. 949.645.2111www.biomerica.com Source: Biomerica

RedHill plans to submit UK MAA1 for Talicia for H. pylori infection, using MHRA's2 new fast-track approval process, referencing FDA approval, with potential UK approval in Q4/25 Listed by ACG3 Clinical Guideline as a first-line option, Talicia is the leading branded H. pylori therapy prescribed by U.S. gastroenterologists and the only FDA-approved all-in-one, low-dose rifabutin-based therapy designed to address H. pylori resistance to other antibiotics Talicia is also approved and launched in the UAE4 and additional countries may accept UK MHRA approvals as a reference for their own marketing approval processes H. pylori infection is a billion-dollar market opportunity affecting approximately 40% of the UK adult population,5 a third of the U.S. adult population and over 50% of the global adult population6 RALEIGH, N.C., March 18, 2025 /PRNewswire/ -- RedHill Biopharma Ltd. (NASDAQ: RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company, today announced its plan to submit a UK Marketing Authorisation Application (MAA) for Talicia for treatment of helicobacter pylori (H. pylori) infection under the Medicines and Healthcare products Regulatory Agency's (MHRA) International Recognition Procedure (IRP), a fast-track regulatory process for UK drug approvals based on a recognized reference approval. Utilizing the U.S. Food and Drug Administration (FDA) approval of Talicia as reference, potential UK approval could be received as early as the fourth quarter of 2025. Talicia, the only FDA-approved all-in-one, low-dose rifabutin-based therapy designed to address H. pylori resistance to other antibiotics commonly used in H. pylori therapies, is listed in the American College of Gastroenterology (ACG) Guideline as a first-line treatment option and is the number one branded H. pylori therapy prescribed by U.S. gastroenterologists. Some additional countries may accept UK MHRA approvals as a reference for their own approval processes which could expedite ongoing discussions with prospective territorial commercialization partners for Talicia. H. pylori infection affects approximately 35% of the U.S. adult population and over 50% of the global adult population7. It is classified, by the World Health Organization (WHO), as a Group 1 carcinogen and the strongest known risk factor for gastric cancer (causing between 70% to 90% of cases) and a major risk factor for peptic ulcer disease (causing 90% of cases)8. Dror Ben-Asher, RedHill's Chief Executive Officer, said: "The American College of Gastroenterology (ACG) Guideline specifically recommends against the use of clarithromycin as part of any H. pylori treatment regimen without prior susceptibility testing. Resistance to both clarithromycin and levofloxacin, estimated at up to 40%, has been rising significantly and is linked to high H. pylori treatment failure rates – with more than one in three patients failing on standard proton pump inhibitor-clarithromycin triple therapy when used in the face of known clarithromycin resistance9. Talicia is now the leading prescribed branded H. pylori therapy by U.S. gastroenterologists, with the ACG Guideline listing it as first-line treatment option for H. pylori infection, based on Talicia's proven superior efficacy – up to 90% effective - and safety, zero to minimal rifabutin resistance, and its convenient FDA-approved three-times daily (TID) 'breakfast, lunch, and dinner' dosing, providing for easier adherence.10,11,12 Almost 40% of the UK population are infected by H. pylori13, 14 and 18 people are diagnosed with gastric cancer in the UK every day15, despite confirmed eradication of H. pylori infection leading to a 75% decreased risk of gastric cancer.16 We are committed to expanding the global access and sales of Talicia following approvals in the U.S. and UAE4, and planned UK submission, and we are exploring opportunities with potential commercialization partners in this global predicted billion-dollar market." About Talicia Approved by the FDA for the treatment of H. pylori infection in adults in November 2019, Talicia is a novel, fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole). Talicia has received eight years of U.S. market exclusivity under its Qualified Infectious Disease Product (QIDP) designation and is also covered by U.S. patents which extend patent protection until 2034 with additional patents and applications pending and granted in various territories worldwide. Talicia is also approved by the United Arab Emirates (UAE) Ministry of Health and was launched there by Ghassan Aboud Group (GAG) in August 2024. About RedHill Biopharma RedHill Biopharma Ltd. (NASDAQ: RDHL) is a specialty biopharmaceutical company primarily focused on U.S. development and commercialization of drugs for gastrointestinal diseases, infectious diseases and oncology. RedHill promotes the FDA approved gastrointestinal drug Talicia®, for the treatment of Helicobacter pylori (H. pylori) infection in adults17. RedHill's key clinical late-stage development programs include: (i) opaganib (ABC294640), a first-in-class, orally administered sphingosine kinase-2 (SPHK2) selective inhibitor with anticancer, anti-inflammatory and antiviral activity, targeting multiple indications with U.S. government and academic collaborations for development for radiation and chemical exposure indications such as GI-Acute Radiation Syndrome (GI-ARS), a Phase 2/3 program for hospitalized COVID-19, and a Phase 2 program study in prostate cancer in combination with Bayer's darolutamide; (ii) RHB-204 with a planned Phase 2 study for Crohn's disease and Phase 3-stage for pulmonary nontuberculous mycobacteria (NTM) disease; (iii) RHB-104, with positive results from a first Phase 3 study for Crohn's disease; (iv) RHB-107 ( upamostat), an oral broad-acting, host-directed, serine protease inhibitor with potential for pandemic preparedness, is in late-stage development as a treatment for non-hospitalized symptomatic COVID-19 and is also targeting multiple other cancer and inflammatory gastrointestinal diseases; and (v) RHB-102, with potential UK submission for chemotherapy and radiotherapy induced nausea and vomiting, positive results from a Phase 3 study for acute gastroenteritis and gastritis and positive results from a Phase 2 study for IBS-D. RHB-102 is partnered with Hyloris Pharma (EBR: HYL) for worldwide development and commercialization outside North America. More information about the Company is available at / X.com/RedHillBio. Forward Looking Statements This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 and may discuss investment opportunities, stock analysis, financial performance, investor relations, and market trends. Such statements may be preceded by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words and include, among others, statements regarding the potential submission of Talicia® for UK Marketing Authorisation and any approval thereof and statements regarding the potential effects of Talicia® in the treatment of Helicobacter pylori infection. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation: the risk that the Company may not submit a UK MAA for Talicia and if it does that submission may not be successful; the risk that the development of RHB-204 for Crohn's disease may not be completed and if completed may not be successful; the risk that the Company will not benefit from its agreement with Hyloris as currently anticipated; the Company's ability to maintain compliance with the Nasdaq Capital Market's listing requirements; the risk that the addition of new revenue generating products or out-licensing transactions will not occur; the risk of current uncertainty regarding U.S. government research and development funding and that the U.S. government is under no obligation to continue to support development of our products and can cease such support at any time; the risk that acceptance onto the RNCP Product Development Pipeline or other governmental and non-governmental development programs will not guarantee ongoing development or that any such development will not be completed or successful; the risk that the FDA does not agree with the Company's proposed development plans for its programs; the risk that observations from preclinical studies are not indicative or predictive of results in clinical trials; the risk that the Company's development programs and studies may not be successful and, even if successful, such studies and results may not be sufficient for regulatory applications, including emergency use or marketing applications, and that additional studies may be required; the risk of market and other conditions and that the Company will not successfully commercialize its products; as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company's research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company's ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of any necessary commercial companion diagnostics; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company's receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company's therapeutic candidates and Talicia®; (v) the Company's ability to successfully commercialize and promote Talicia®; (vi) the Company's ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the U.S. that achieve commercial success and build its own marketing and commercialization capabilities; (viii) the interpretation of the properties and characteristics of the Company's therapeutic candidates and the results obtained with its therapeutic candidates in research, pre-clinical studies or clinical trials; (ix) the implementation of the Company's business model, strategic plans for its business and therapeutic candidates; (x) the scope of protection the Company is able to establish and maintain for intellectual property rights covering its therapeutic candidates and its ability to operate its business without infringing the intellectual property rights of others; (xi) parties from whom the Company licenses its intellectual property defaulting in their obligations to the Company; (xii) estimates of the Company's expenses, future revenues, capital requirements and needs for additional financing; (xiii) the effect of patients suffering adverse experiences using investigative drugs under the Company's Expanded Access Program; (xiv) competition from other companies and technologies within the Company's industry; and (xv) the hiring and employment commencement date of executive managers. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company's filings with the Securities and Exchange Commission (SEC), including the Company's Annual Report on Form 20-F filed with the SEC on April 8, 2024. All forward-looking statements included in this press release are made only as of the date of this press release. The Company assumes no obligation to update any written or oral forward-looking statement, whether as a result of new information, future events or otherwise unless required by law. Company Contact: Adi Frish Chief Corporate & Business Development Officer RedHill Biopharma +972-54-6543-112 [email protected] Category: R&D [1] MAA refers to Marketing Authorisation Application [2] MHRA refers to Medicines and Healthcare products Regulatory Authority [3] ACG refers to American College of Gastroenterologists [4] UAE refers to United Arab Emirates [5] [6] Hooi JKY, et al. Global Prevalence of Helicobacter Pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017;153(2):420–429. [7] Hooi JKY, et al. Global Prevalence of Helicobacter Pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017;153(2):420–429. [8] [9] Chey et al. Am J Gastroenterol. 2024 [10] Resistance rates as determined by in vitro testing of 345 H. pylori isolates collected at baseline from patients enrolled in the Talicia pivotal trial [11] Defined as the PK population which included those subjects in the ITT population who had demonstrated presence of any component of investigational drug at visit 3 (approx. day 13) or had undetected levels drawn >250 hours after the last dose. [12] The pivotal Phase 3 study with Talicia® demonstrated 84% eradication of H. pylori infection with Talicia® vs. 58% in the active comparator arm (ITT analysis, p<0.0001). [13] [14] Hooi JKY, et al. Global Prevalence of Helicobacter Pylori Infection: Systematic Review and Meta-Analysis. Gastroenterology. 2017;153(2):420–429. [15] [16] Kumar S, et al. Risk Factors and Incidence of Gastric Cancer After Detection of Helicobacter pylori Infection: A Large Cohort Study. Gastroenterology. 2020;158(3) [17] Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is indicated for the treatment of H. pylori infection in adults. For full prescribing information see: . Logo: SOURCE RedHill Biopharma Ltd. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Strong results to date of Vafseo U.S. launch; expect Vafseo Q1 2025 net product revenues of approximately $10-$11 million Cash resources and cash from operations expected to fund current operating plan for at least two years Akebia to Host Conference Call at 8:00 a.m. ET on March 13, 2025 CAMBRIDGE, Mass., March 13, 2025 (GLOBE NEWSWIRE) -- Akebia Therapeutics®, Inc. (Nasdaq: AKBA), a biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease, today reported financial results for the fourth quarter and full year ended December 31, 2024 and recent business highlights. As previously announced, Vafseo® (vadadustat) shipments to customers began January 9, 2025. Akebia expects Vafseo first quarter 2025 net product revenues of approximately $10-$11 million. Commenting on the Vafseo launch, John P. Butler, Chief Executive Officer of Akebia said: “We believe Vafseo can be a new standard of care for the treatment of anemia due to chronic kidney disease (CKD). The U.S. product launch is underway and our initial execution across multiple initiatives demonstrates we are making significant early progress towards that goal for dialysis patients. We launched Vafseo with commercial supply contracts in place with dialysis organizations caring for nearly 100% of dialysis patients in the U.S., which we believe is the first time a drug with Transitional Drug Add-on Payment Adjustment (TDAPA) reimbursement has done so. We are very pleased with the early results and expect to generate Vafseo net product revenue of approximately $10-$11 million in the first quarter of 2025.” Mr. Butler continued, “We are also excited about our potential to expand the Vafseo label to the non-dialysis CKD population, and plan to take advantage of the opportunity to meet with the U.S. Food and Drug Administration to discuss the Phase 3 VALOR study protocol. We believe taking the time for this meeting can help drive our efforts to bring a new product to market to treat this underserved patient population. We expect to initiate the VALOR study in the second half of this year.” Vafseo U.S. Commercial Update: Vafseo began shipping to dialysis centers and authorized distributors on January 9, 2025 and the first prescription was written on January 13, 2025.As of today, three of the top four dialysis organizations have placed orders.Through the end of February, more than 500 prescribers have written a prescription for Vafseo and each prescriber, on average, has written approximately 8 prescriptions. Additional Key Business Updates: In December 2024, Akebia announced that U.S. Renal Care enrolled the first patients in VOICE, a collaborative clinical trial of Vafseo designed to assess mortality and hospitalization in patients treated with Vafseo compared to current standard of care. U.S. Renal Care has now enrolled more than half of the total target of 2,200 patients.Vafseo has been recommended for symptomatic anemia in adults undergoing dialysis for CKD by the United Kingdom (U.K.) National Institute for Health and Care Excellence (NICE), a distinction especially relevant for practitioners and commissioners making care choices for patients in the U.K. and of interest globally. Akebia’s partner Medice has now launched Vafseo in the U.K.Akebia plans to initiate a Phase 3 clinical trial (VALOR) to study the use of vadadustat in treating anemia in late-stage CKD patients who are not on dialysis. Akebia expects the VALOR clinical trial to begin in the second half of 2025. Financial Results Revenues: Total revenues were $46.5 million in the fourth quarter of 2024 compared to $56.2 million in the fourth quarter of 2023, and $160.2 million for the full-year 2024 compared to $194.6 million for the full-year 2023. Auryxia® (ferric citrate) net product revenues were $44.4 million in the fourth quarter of 2024 compared to $53.2 million in the fourth quarter of 2023, and $152.2 million for the full-year 2024 compared to $170.3 million for the full-year 2023. These decreases were primarily driven by a reduction in volume, partially offset by price increases and execution of our contracting strategy with third party payors.License, collaboration and other revenues were $2.1 million in the fourth quarter of 2024 compared to $3.0 million in the fourth quarter of 2023, and $8.0 million for the full-year 2024 compared to $24.3 million for the full-year 2023. License, collaboration and other revenue in the full-year 2023 included a one-time $10 million license agreement-related upfront payment. COGS: Cost of goods sold was $20.4 million in the fourth quarter of 2024 compared to $18.7 million in the fourth quarter of 2023, and $63.2 million for the full-year 2024 compared to $74.1 million for the full-year 2023. In the full-year 2024 and during the fourth quarter of 2023, we realized a $12.3 million benefit, and a $4.3 million benefit, respectively, due to our ability to sell inventory previously written down as excess inventory. In addition, the decrease in cost of goods sold in both period-over-period comparisons reflects lower Auryxia sales volumes in 2024 as compared to 2023.R&D Expenses: Research and development expenses were $11.8 million in the fourth quarter of 2024 compared to $9.9 million in the fourth quarter of 2023, and $37.7 million for the full-year 2024 compared to $63.1 million for the full-year 2023. The quarterly increase was driven by expense related to the amendment of our license agreement with Cyclerion. The yearly decrease was driven by the completion of activities related to certain clinical trials, lower headcount-related costs and decreased professional service and consulting expenses.SG&A Expenses: Selling, general and administrative expenses were $27.7 million in the fourth quarter of 2024 compared to $25.4 million in the fourth quarter of 2023, and $106.5 million for the full-year 2024 compared to $100.2 million for the full-year 2023. These increases were driven by costs incurred in connection with preparatory activities related to the Vafseo U.S. launch.Net Income / Loss: Net loss was $22.8 million in the fourth quarter of 2024 compared to net income of $0.6 million in the fourth quarter of 2023. Net loss was $69.4 million for the full-year 2024 compared to $51.9 million for the full-year 2023. The increases in net loss were impacted by lower period-over-period revenues, as well as by non-cash interest expense incurred in 2024 related to the settlement royalty liability in connection with the Vifor Termination and Settlement Agreement we signed in July 2024, which was $4.9 million in the fourth quarter of 2024 and $9.3 million for the full-year 2024.Cash Position: We expect our existing cash resources and cash from operations will be sufficient to fund our current operating plan for at least two years. Cash and cash equivalents as of December 31, 2024, were approximately $51.9 million as compared to $42.9 million as of December 31, 2023. Post year-end, we further strengthened our financial position, including through share sales under our at-the-market facility, which raised $18.4 million. In addition, on February 3, 2025, we elected to access Tranche C of the BlackRock Credit Agreement, resulting in net proceeds of $9.3 million. Conference Call Akebia will host a conference call on Thursday, March 13 at 8:00 a.m. Eastern Time to discuss fourth quarter and full year 2024 earnings. To access the call, please register by clicking on this Registration Link, and you will be provided with dial in details. To avoid delays and ensure timely connection, we encourage dialing into the conference call 15 minutes ahead of the scheduled start time. A live webcast of the conference call will be available via the “Investors” section of Akebia's website at: https://ir.akebia.com/. An online archive of the webcast can be accessed via the Investors section of Akebia's website at https://ir.akebia.com approximately two hours after the event. About Akebia Therapeutics Akebia Therapeutics, Inc. is a fully integrated biopharmaceutical company with the purpose to better the lives of people impacted by kidney disease. Akebia was founded in 2007 and is headquartered in Cambridge, Massachusetts. For more information, please visit our website at www.akebia.com, which does not form a part of this release. About Vafseo® (vadadustat) tablets Vafseo® (vadadustat) tablets is a once-daily oral hypoxia-inducible factor prolyl hydroxylase inhibitor that activates the physiologic response to hypoxia to stimulate endogenous production of erythropoietin, increasing hemoglobin and red blood cell production to manage anemia. Vafseo is approved for use in 37 countries. INDICATION VAFSEO is indicated for the treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least three months. Limitations of Use VAFSEO has not been shown to improve quality of life, fatigue, or patient well-being.VAFSEO is not indicated for use: As a substitute for red blood cell transfusions in patients who require immediate correction of anemia.In patients with anemia due to CKD not on dialysis. IMPORTANT SAFETY INFORMATION about VAFSEO (vadadustat) tablets WARNING: INCREASED RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, and THROMBOSIS OF VASCULAR ACCESS. VAFSEO increases the risk of thrombotic vascular events, including major adverse cardiovascular events (MACE). Targeting a hemoglobin level greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events, as occurs with erythropoietin stimulating agents (ESAs), which also increase erythropoietin levels. No trial has identified a hemoglobin target level, dose of VAFSEO, or dosing strategy that does not increase these risks. Use the lowest dose of VAFSEO sufficient to reduce the need for red blood cell transfusions. CONTRAINDICATIONS Known hypersensitivity to VAFSEO or any of its componentsUncontrolled hypertension WARNINGS AND PRECAUTIONS Increased Risk of Death, Myocardial Infarction (MI), Stroke, Venous Thromboembolism, and Thrombosis of Vascular AccessA rise in hemoglobin (Hb) levels greater than 1 g/dL over 2 weeks can increase these risks. Avoid in patients with a history of MI, cerebrovascular event, or acute coronary syndrome within the 3 months prior to starting VAFSEO. Targeting a Hb level of greater than 11 g/dL is expected to further increase the risk of death and arterial and venous thrombotic events. Use the lowest effective dose to reduce the need for red blood cell (RBC) transfusions. Adhere to dosing and Hb monitoring recommendations to avoid excessive erythropoiesis. HepatotoxicityHepatocellular injury attributed to VAFSEO was reported in less than 1% of patients, including one severe case with jaundice. Elevated serum ALT, AST, and bilirubin levels were observed in 1.8%, 1.8%, and 0.3% of CKD patients treated with VAFSEO, respectively. Measure ALT, AST, and bilirubin before treatment and monthly for the first 6 months, then as clinically indicated. Discontinue VAFSEO if ALT or AST is persistently elevated or accompanied by elevated bilirubin. Not recommended in patients with cirrhosis or active, acute liver disease. HypertensionWorsening of hypertension was reported in 14% of VAFSEO and 17% of darbepoetin alfa patients. Serious worsening of hypertension was reported in 2.7% of VAFSEO and 3% of darbepoetin alfa patients. Cases of hypertensive crisis, including hypertensive encephalopathy and seizures, have also been reported in patients receiving VAFSEO. Monitor blood pressure. Adjust anti-hypertensive therapy as needed. SeizuresSeizures occurred in 1.6% of VAFSEO and 1.6% of darbepoetin alfa patients. Monitor for new-onset seizures, premonitory symptoms, or change in seizure frequency. Gastrointestinal (GI) ErosionGastric or esophageal erosions occurred in 6.4% of VAFSEO and 5.3% of darbepoetin alfa patients. Serious GI erosions, including GI bleeding and the need for RBC transfusions, were reported in 3.4% of VAFSEO and 3.3% of darbepoetin alfa patients. Consider this risk in patients at increased risk of GI erosion. Advise patients about signs of erosions and GI bleeding and urge them to seek prompt medical care if present. Serious Adverse Reactions in Patients with Anemia Due to CKD and Not on DialysisThe safety of VAFSEO has not been established for the treatment of anemia due to CKD in adults not on dialysis and its use is not recommended in this setting. In large clinical trials in adults with anemia of CKD who were not on dialysis, an increased risk of mortality, stroke, MI, serious acute kidney injury, serious hepatic injury, and serious GI erosions was observed in patients treated with VAFSEO compared to darbepoetin alfa. MalignancyVAFSEO has not been studied and is not recommended in patients with active malignancies. Malignancies were observed in 2.2% of VAFSEO and 3.0% of darbepoetin alfa patients. No evidence of increased carcinogenicity was observed in animal studies. ADVERSE REACTIONS The most common adverse reactions (occurring at ≥ 10%) were hypertension and diarrhea. DRUG INTERACTIONS Iron supplements and iron-containing phosphate binders: Administer VAFSEO at least 1 hour before products containing iron.Non-iron-containing phosphate binders: Administer VAFSEO at least 1 hour before or 2 hours after non-iron-containing phosphate binders.BCRP substrates: Monitor for signs of substrate adverse reactions and consider dose reduction.Statins: Monitor for statin-related adverse reactions. Limit the daily dose of simvastatin to 20 mg and rosuvastatin to 5 mg. USE IN SPECIFIC POPULATIONS Pregnancy: May cause fetal harm.Lactation: Breastfeeding not recommended until two days after the final dose.Hepatic Impairment: Not recommended in patients with cirrhosis or active, acute liver disease. Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING and Medication Guide. Forward-Looking Statements Statements in this press release regarding Akebia Therapeutics, Inc.'s ("Akebia's") strategy, plans, prospects, expectations, beliefs, intentions and goals are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, as amended, and include, but are not limited to, statements regarding: Akebia’s commercial supply contract coverage for Vafseo with dialysis organizations and Akebia's ability to make Vafseo available to nearly 100% of patients on dialysis in the U.S.; Akebia's plans and expectations with respect to potential Vafseo label expansion to treat anemia in late-stage CKD patients who are not on dialysis, including Akebia's expectations as to the timing of a Phase 3 trial; Akebia's statements regarding meeting with the FDA to discuss its Phase 3 study protocol; Akebia’s expectation with respect to its net product revenue for the first quarter 2025; Akebia’s plans to establish Vafseo as the new standard of care for dialysis patients with anemia due to CKD and progress towards that goal; Akebia’s expectations regarding the VOICE trial; and Akebia's expectations that its existing cash resources and cash from operations will be sufficient to fund its current operating plan for at least two years. The terms "intend," "believe," "plan," "goal," "potential," "anticipate, "estimate," "expect," "future," "will," "continue," derivatives of these words, and similar references are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results, performance or experience may differ materially from those expressed or implied by any forward-looking statement as a result of various risks, uncertainties and other factors, including, but not limited to, risks associated with: the commercial availability of Vafseo; the potential demand and market potential and acceptance of, as well as coverage and reimbursement related to, Auryxia® and Vafseo, including estimates regarding the potential market opportunity; the competitive landscape for Auryxia and Vafseo, including potential generic entrants; the ability of Akebia to attract and retain qualified personnel; Akebia's ability to implement cost avoidance measures and reduce operating expenses; decisions made by health authorities, such as the FDA, with respect to regulatory filings and other interactions; the potential therapeutic benefits, safety profile, and effectiveness of Vafseo; the results of preclinical and clinical research; manufacturing, supply chain and quality matters and any recalls, write-downs, impairments or other related consequences or potential consequences; and early termination of any of Akebia's collaborations. Other risks and uncertainties include those identified under the heading "Risk Factors" in Akebia's Quarterly Report on Form 10-Q for the quarter ended September 30, 2024, and other filings that Akebia may make with the U.S. Securities and Exchange Commission in the future. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and, except as required by law, Akebia does not undertake, and specifically disclaims, any obligation to update any forward-looking statements contained in this press release. Akebia Therapeutics®, Auryxia® and Vafseo® are registered trademarks of Akebia Therapeutics, Inc. and its affiliates. Akebia Therapeutics Contact Mercedes Carrasco mcarrasco@akebia.com AKEBIA THERAPEUTICS, INC.Consolidated Statements of Operations Quarters Ended December 31, Years Ended December 31, (in thousands, except share and per share data) 2024 2023 2024 2023 Revenues: Product revenue, net$44,370 $53,233 $152,180 $170,301 License, collaboration and other revenue 2,127 2,963 8,000 24,322 Total revenues 46,497 56,196 160,180 194,623 Cost of goods sold: Cost of product and other revenue 11,355 9,656 27,135 38,107 Amortization of intangibles 9,010 9,010 36,042 36,042 Total cost of goods sold 20,365 18,666 63,177 74,149 Operating expenses: Research and development 11,787 9,866 37,652 63,079 Selling, general and administrative 27,674 25,434 106,545 100,233 License expense 978 856 3,220 3,237 Restructuring — — 58 181 Total operating expenses 40,439 36,156 147,475 166,730 Operating income (loss) (14,307) 1,374 (50,472) (46,256)Other income (expense), net (6,822) (761) (18,091) (5,145)Change in fair value of warrant liability (1,675) — (330) — Loss on extinguishment of debt — — (517) — Loss on lease termination — — — (524)Net income (loss)$(22,804) $613 $(69,410) $(51,925)Net income (loss) per share Basic and diluted$(0.10) $— $(0.33) $(0.28)Weighted-average number of common shares outstanding:Basic 218,699,008 189,903,365 210,946,658 187,465,448 Diluted 218,699,008 190,496,470 210,946,658 187,465,448 Selected Balance Sheet Data(unaudited) December 31, (in thousands) 2024 2023 Cash and cash equivalents $51,870 $42,925 Working capital $32,917 $18,279 Total assets $220,670 $241,703 Total stockholders’ (deficit) equity $(49,185) $(30,584)