Thrombotic Microangiopathies

– The Steering Committee brings together distinguished clinical experts in AML from leading National Comprehensive Cancer Network Centers – SEATTLE--(BUSINESS WIRE)--Apr. 10, 2025-- Omeros Corporation (Nasdaq: OMER) today announced the establishment of the Omeros Oncology Clinical Steering Committee to advance Omeros’ OncotoX biologics program focused on acute myeloid leukemia (AML). AML is the most fatal form of leukemia and accounts for approximately 80 percent of acute leukemias in adults and one-third of all cancers affecting the blood/bone marrow, representing a high unmet need. Omeros’ OncotoX program for AML consists of proprietary targeted, engineered molecules (about half the size of an antibody) that deliver a toxic payload within the cancer cells, thereby killing them. Members of the Omeros Oncology Clinical Steering Committee include: Naval Daver, M.D., Professor and Director of the Leukemia Research Alliance Program in the Department of Leukemia at MD Anderson Cancer Center (Chair of the Omeros Oncology Clinical Steering Committee) Aref Al-Kali, M.D., Chair of the Acute Myeloid Group and Research Chair of the Acute Leukemia and Myeloid Neoplasms Disease Group at Mayo Clinic Jessica K. Altman, M.D., Professor of Medicine in the Division of Hematology and Oncology and Director of the Leukemia Program of Robert H. Lurie Comprehensive Cancer Center at Northwestern University Jayastu Senapati, M.B.B.S., M.D., D.M., Assistant Professor in the Department of Leukemia at MD Anderson Cancer Center Mithun Shah, M.D., Ph.D., Assistant Professor of Medicine and Oncology, and Consultant in the Division of Hematology at Mayo Clinic Anthony S. Stein, M.D., Co-director of the Gehr Family Center for Leukemia Research within the Hematologic Malignancies and Stem Cell Transplantation Institute at City of Hope Eytan M. Stein, M.D., Chief of the Leukemia Service and Director of the Program for Drug Development in Leukemia in the Division of Hematologic Malignancies at Memorial Sloan Kettering Cancer Center Roland B. Walter, M.D., Ph.D., M.S., Professor in the Translational Science and Therapeutics Division and José Carreras/E. Donnall Thomas Endowed Chair for Cancer Research at the Fred Hutchinson Cancer Center The steering committee will, among other activities, assist Omeros with development of the OncotoX-AML program, clinical trial design and interactions with institutional review boards and will participate in OncotoX-AML clinical trials. “AML is a devastating disease, and these patients have difficulty tolerating the side effects of chemotherapeutic agents and current antibody-drug conjugates, which generally have a narrow therapeutic index,” stated Naval Daver, M.D., Professor and Director of the Leukemia Research Alliance Program in the Department of Leukemia at MD Anderson Cancer Center and Chair of the Omeros Oncology Clinical Steering Committee. “The OncotoX platform is designed to kill only dividing cancer cells while sparing normal cells. In animal models using cell lines derived from AML patients, the OncotoX-AML molecule has shown superior efficacy to current standard of care in AML treatment, and its potential utility extends broadly beyond AML to other types of leukemia. Together with my esteemed physician-scientist colleagues on the steering committee, I look forward to advancing the Omeros therapeutic for AML and bringing this novel treatment to patients as quickly as possible.” Across extensive in vivo and ex vivo studies, the OncotoX-AML therapeutic has shown to be highly effective even at very low doses, providing a significant survival benefit over currently approved combination therapy (venetoclax and azacytidine). These studies, conducted with human cell lines in well-established animal models and considered predictive of clinical response, have targeted AML tumors with mutational backgrounds commonly found in nearly 90 percent of AML patients (TP53, NPM1, KMT2a, and FLT3) indicating that the OncotoX-AML therapeutic could be “mutation-agnostic,” a currently large unmet need for oncologists and their patients. In studies using primary AML derived from patients, the OncotoX molecule preferentially and efficiently kills AML blasts (abnormal myeloid cells). OncotoX-AML also targets leukemia stem cells (LSC), which are often refractory to chemotherapy and represent another major challenge in the treatment of AML. The OncotoX-AML therapeutic is designed specifically to kill both AML blasts and LSCs that can lead to relapse. Preliminary in vivo tolerability studies demonstrate that the OncotoX therapeutic is well tolerated at doses substantially greater than one order of magnitude above efficacious doses without causing neutropenia or meaningful changes in blood chemistry values. Omeros is initiating IND-enabling work for its OncotoX-AML therapeutic. Clinical efficacy in AML, considered one of the most aggressive leukemias, is thought to bode well for a therapeutic agent’s broad applicability across leukemias. In addition to OncotoX-AML, Omeros’ portfolio of oncology platforms include signaling and antigen-driven immunomodulators, immune memory-enhancing immunostimulators, and an adoptive T-cell technology that, unlike other cell therapy approaches, does not require cellular engineering. “We are very pleased to be working with all the members of our oncology steering committee,” said Gregory A. Demopulos, M.D., Omeros’ Chairman and Chief Executive Officer. “Each is an internationally recognized leader in the fields of leukemia and AML and has been integrally involved in the development of new treatments for their patients. Their willingness to invest time and effort in our OncotoX-AML program is a strong endorsement of our molecule’s potential and, with their help, we look forward to assessing this next-generation therapeutic in AML patients.” In the U.S. alone, AML is diagnosed in over 20,000 patients annually and is responsible each year for more than 11,000 deaths. In 2030, the global AML therapeutic market size is projected to be over $6 billion with the leukemia therapeutic market forecast at $29 billion. About Omeros’ Oncology Programs Omeros’ oncology programs are informed by a deep understanding of both the innate (complement-mediated) and adaptive (CD4 & CD8 T-cells) immune systems to derive highly differentiated, first-in-class therapeutic programs to treat a wide range of cancers. While significant progress has been made within oncology through targeted therapies, advanced biologics and immuno-therapies, toxicity and efficacy shortcomings remain significant. Omeros is focused on moving beyond these approaches with a family of wholly novel molecular and cellular platforms designed to be more effective, targeting both cell-surface and intracellular cancer antigens, with less toxicity. Our oncology franchise involves three distinct platforms – OncotoX, immunomodulators, and immunostimulators in combination with adoptive T-cell therapy. IND-enabling work has been initiated to advance to clinic our OncotoX-AML program comprised of engineered molecules designed to target and kill cancer cells with precision. Our immunomodulator platform is based on our identifying and evidencing the importance of certain molecules that selectively target T cells to regulate and potentiate immune responses. Our adoptive T-cell technology, unlike other cell therapy approaches, does not require cellular engineering and is being developed in concert with our immunostimulator platform to advance beyond the challenges of current vaccine approaches, which induce only transient and ineffective immune responses. By combining tumor antigens with a potent adjuvant, these novel, engineered biologics are designed specifically to target and activate antigen-presenting cells, leading to amplification of cancer-specific T and B cells to eliminate existing tumor cells and, importantly, to generate immune memory against future cancer relapse. Collectively, our portfolio of oncology platforms has the potential to deliver substantially more effective and safer treatments broadly across hematological malignancies and solid tumors. About Omeros Corporation Omeros is an innovative biopharmaceutical company committed to discovering, developing and commercializing first-in-class small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders, including complement-mediated diseases and cancers, as well as addictive and compulsive disorders. Omeros’ lead MASP-2 inhibitor narsoplimab targets the lectin pathway of complement and is the subject of a biologics license application pending before FDA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy. Omeros’ long-acting MASP-2 inhibitor OMS1029 has successfully completed Phase 1 single- and multiple-ascending dose clinical studies. Zaltenibart, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in Phase 3 clinical development for paroxysmal nocturnal hemoglobinuria and is being evaluated in an ongoing Phase 2 clinical trial for complement 3 glomerulopathy. Funded by the National Institute on Drug Abuse, Omeros’ lead phosphodiesterase 7 inhibitor OMS527 is in clinical development for the treatment of cocaine use disorder. Omeros also is advancing a broad portfolio of novel cellular and molecular immuno-oncology programs. For more information about Omeros and its programs, visit www.omeros.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which are subject to the “safe harbor” created by those sections for such statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “goal,” “intend,” “likely,” “look forward to,” “may,” “objective,” “plan,” “potential,” “predict,” “project,” “should,” “slate,” “target,” “will,” “would” and similar expressions and variations thereof. Forward-looking statements, including statements regarding the anticipated safety and therapeutic benefits of Omeros’ drug candidates and plans for future development thereof are based on management’s beliefs and assumptions and on information available to management only as of the date of this press release. Omeros’ actual results could differ materially from those anticipated in these forward-looking statements for many reasons, including, without limitation, our financial condition and results of operations, inability to raise capital when required to fund our operations and development plans, unfavorable, unexpected or inconclusive results of our preclinical and clinical development activities, unexpected outcomes of regulatory processes in relevant jurisdictions, including those associated with other Omeros’ development programs, challenges associated with manufacture or supply of our drug candidates or other materials needed to support preclinical and clinical development, intellectual property claims, competitive developments, litigation, and the risks, uncertainties and other factors described under the heading “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 2025. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law. View source version on businesswire.com: https://www.businesswire.com/news/home/20250410587782/en/ Jennifer Cook Williams Cook Williams Communications, Inc. Investor and Media Relations IR@omeros.com Source: Omeros Corporation

PARSIPPANY, NJ, USA and INCHEON, Korea I April 07, 2025 I Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Samsung Bioepis Co., Ltd. today announced the availability of EPYSQLI ® (eculizumab-aagh) in the U.S. EPYSQLI is a biosimilar to Soliris ® (eculizumab) for the treatment of paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS) and generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AchR) antibody positive. EPYSQLI will be offered at a 30% discount of the Wholesale Acquisition Cost (WAC) of the reference product, Soliris ® , offering one of the greatest cost-saving biosimilars to Soliris ® in the U.S. “Individuals living with rare diseases, including paroxysmal nocturnal hemoglobinuria, atypical hemolytic uremic syndrome and generalized myasthenia gravis, often have limited access to life-enhancing medicines,” said Thomas Rainey, Senior Vice President, U.S. Biosimilars at Teva. “We are proud to launch EPYSQLI in the U.S. as a new, more affordable treatment option to help expand access to these underserved communities, further expanding our biosimilars medicine portfolio and efforts to deliver important medicines to patients through strategic partnerships that leverage our proven commercialization abilities.” “Life-threatening diseases such as PNH, aHUS and gMG, if left untreated, can lead to kidney disease, kidney failure or respiratory failure, and it is important for patients to have early access to treatment. The availability of EPYSQLI means that patients now have an additional treatment option available at a lower cost, with the proven quality, safety and efficacy comparable to the reference product. Based on our robust track record supplying biosimilars in the U.S., we are well-positioned to deliver this life-changing medicine to patients,” said Linda MacDonald, Executive Vice President and Head of Global Commercial Division of Samsung Bioepis. “Our mission is to positively impact and ensure the sustainability of health care systems by offering affordable, quality-assured, safe and effective biologic medicines. We will work closely with Teva to ensure access of this medicine for payers, healthcare professionals and patients in the U.S.,” she added. The monoclonal antibody and anti-C5 complement inhibitor eculizumab is a well-established standard of care to treat PNH and aHUS, rare diseases with an estimated U.S. prevalence of approximately 50,000 and 5,000 respectively. 1,2 Approximately 70% of eculizumab-treated PNH patients are not dosed according to the label, and two-thirds of patients discontinue eculizumab within an average of 1.5 years, which can be attributed to several factors including the high treatment cost. 3 Biosimilars, like EPYSQLI, are highly similar to their reference product with no clinically meaningful differences in safety, purity, or potency, and can increase the affordability and accessibility associated with these therapies. Biosimilars are approved according to the same standards of pharmaceutical quality that apply to all biological medicines, with comparable safety and efficacy to the reference product expected. 4 The introduction of biosimilars leads to higher utilization of the molecule as lower costs offer increased access to patients. 5 In July 2024, EPYSQLI was approved by the U.S. Food and Drug Administration (FDA) as a biosimilar to Soliris ® for the treatment of patients with PNH to reduce hemolysis, and aHUS to inhibit complement-mediated thrombotic microangiopathy. In November 2024, its indication was expanded to include the treatment of gMG in adult patients who are AchR antibody positive. The FDA has provisionally determined that EPYSQLI will be interchangeable with the reference biologic Soliris ® , following the expiration of exclusivity for the first interchangeable biosimilar. In January 2025, Teva and Samsung Bioepis entered into a strategic partnership for the commercialization of EPYSQLI in the U.S. market. Under the terms of the agreement, Samsung Bioepis handles development, manufacturing and supply, while Teva is responsible for the commercialization of the product in the U.S., leveraging its experience and extensive sales and marketing infrastructure. About EPYSQLI ® (eculizumab-aagh) injection, for intravenous use EPYSQLI is a complement inhibitor indicated for the treatment of patients with: Limitation of Use: EPYSQLI is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS). Please click here for full Prescribing Information for EPYSQLI, including BOXED WARNINGS. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a different kind of global biopharmaceutical leader, one that operates across the full spectrum of innovation to reliably deliver medicines to patients worldwide. For over 120 years, Teva’s commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its 37,000 employees across 57 markets to advance health by developing medicines for the future while championing the production of generics and biologics. We are dedicated to addressing patients’ needs, now and in the future. Moving forward together with science that treats, inspired by the people we serve. To learn more about how Teva is all in for better health, visit www.tevapharm.com . About Samsung Bioepis Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X , LinkedIn . References SOURCE: Samsung Bioepis

EAST HANOVER, NJ, USA I April 2, 2025 I Novartis today announced the US Food and Drug Administration (FDA) has granted accelerated approval for Vanrafia ® (atrasentan), a potent and selective endothelin A (ETA) receptor antagonist, for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression. This is generally defined as a urine protein-to-creatinine ratio (UPCR) ≥1.5 g/g 1 . Vanrafia is a once-daily, non-steroidal, oral treatment that can be added onto supportive care, including a renin-angiotensin system (RAS) inhibitor with or without a sodium-glucose co-transporter-2 (SGLT2) inhibitor 1,2 . Vanrafia was granted accelerated approval based on a prespecified interim analysis of the Phase III ALIGN study measuring the reduction of proteinuria at 36 weeks compared to placebo 1 . It has not been established whether Vanrafia slows kidney function decline in patients with IgAN. The continued approval of Vanrafia may be contingent upon the verification of clinical benefit from the ongoing Phase III ALIGN study evaluating whether Vanrafia slows disease progression as measured by estimated glomerular filtration rate (eGFR) decline at week 136 1 . The eGFR data are expected in 2026 and intended to support traditional FDA approval. “Today’s approval marks an important milestone for people living with IgA nephropathy, offering a new option that can be seamlessly integrated into their existing treatment plan, with no REMS requirement,” said Richard Lafayette, M.D., F.A.C.P., Professor of Medicine, Nephrology and Director of the Glomerular Disease Center at Stanford University Medical Center, and Vanrafia ALIGN Study Investigator and Steering Committee Member. “Vanrafia is a selective ETA receptor antagonist that effectively reduces proteinuria, a major risk factor in IgAN. Taking early, decisive action is critical to help improve outcomes for these patients who too often progress toward kidney failure.” IgAN is a progressive, rare kidney disease in which the immune system attacks the kidneys, often causing glomerular inflammation and proteinuria 10 . With almost 13 out of every million people in the US diagnosed per year, it is one of the most common autoimmune kidney diseases, and each person’s journey is unique 11,12 . Up to 50% of IgAN patients with persistent proteinuria progress to kidney failure within 10 to 20 years of diagnosis, often requiring maintenance dialysis and/or kidney transplantation 3-10 , and response to treatment can vary 12,13 . Effective, targeted therapies with different mechanisms of action can help physicians select the most appropriate treatment for patients 12 . “My son was diagnosed with IgA nephropathy long before there were any medicines approved to treat this condition, so the availability of multiple treatment options is incredibly meaningful for this community,” said Bonnie Schneider, Director and Co-Founder, IgA Nephropathy Foundation. “The approval of Vanrafia broadens the treatment landscape and expands the opportunity to tailor care in a disease that can impact each patient so differently.” Data supporting approval In the ongoing Phase III ALIGN study, patients receiving Vanrafia in combination with a RAS inhibitor achieved clinically meaningful and statistically significant proteinuria reduction of 36.1% (P<0.0001) compared to placebo, with results seen as early as week 6 and sustained through week 36 1,2,14 . The effect of Vanrafia on UPCR was consistent across subgroups, including age, sex, race, and baseline disease characteristics, such as eGFR and proteinuria levels, in the main study cohort 1 . A similar treatment effect of Vanrafia was seen in an additional group of patients treated with both a RAS inhibitor and an SGLT2 inhibitor (37.4% reduction in UPCR vs. placebo) 1 . The ALIGN study showed that Vanrafia has a favorable safety profile consistent with previously reported data 1 . Adverse events reported in ≥2% of patients treated with Vanrafia, and more frequently than placebo, include peripheral edema, anemia, and liver transaminase elevation 1 . Because some endothelin receptor antagonists have caused elevations of aminotransferases, hepatotoxicity, and liver failure, clinicians should obtain liver enzyme testing before initiating Vanrafia and during treatment when clinically indicated. Vanrafia may cause serious birth defects 1 . Vanrafia does not require a REMS program. Transforming care in kidney disease “We are proud to expand the treatment landscape in IgA nephropathy with today’s FDA accelerated approval of Vanrafia. IgAN is a heterogenous condition that requires differentiated therapies with unique mechanisms of action, and with our multi-asset kidney disease portfolio, we are well positioned to support a broad patient population and advance care for this disease,” said Victor Bultó, President, US, Novartis. “Building on our longstanding legacy in nephrology, we continue to rapidly grow our capabilities in this space. Each launch enables us to more effectively reach patients with the most suitable treatment option and deliver on our promise to transform kidney disease care.” This is the third US approval received by Novartis for its kidney disease portfolio in the last year, with Fabhalta ® having been granted FDA approval in C3 glomerulopathy (C3G) in March 2025 and accelerated approval in IgAN in August 2024 15 . Fabhalta is also being studied in a broad range of rare kidney diseases, including atypical hemolytic uremic syndrome (aHUS), immune complex membranoproliferative glomerulonephritis (IC-MPGN) and lupus nephritis (LN). Studies are ongoing to evaluate the safety and efficacy profiles in these investigational indications and support potential regulatory submissions. An investigational subcutaneously administered anti-APRIL monoclonal antibody, zigakibart, is currently in Phase III development in IgAN, with results expected in 2026 16 . About ALIGN The ALIGN study ( NCT04573478 ) is a global, randomized, multicenter, double-blind, placebo-controlled Phase III clinical trial comparing the efficacy and safety of Vanrafia versus placebo in patients with IgAN at risk of progressive loss of kidney function 1,14 . In total, 340 individuals with biopsy-proven IgAN with baseline total proteinuria ≥1 g/day despite optimized RAS inhibitor treatment were randomized to receive once-daily, oral Vanrafia (0.75 mg) or placebo for approximately 132 weeks 1,2 . Patients continue receiving a maximally tolerated and stable dose of a RAS inhibitor as supportive care (unless they are unable to tolerate RAS inhibitor therapy) 1,2 . An additional group of 64 patients receiving an SGLT2 inhibitor for at least 12 weeks was also enrolled 1,2 . The primary efficacy endpoint for the interim analysis is change in proteinuria, a marker of kidney damage, as measured by 24-hour UPCR from baseline to 36 weeks 1,2,14 . Secondary and exploratory objectives include evaluating the change in kidney function from baseline to 136 weeks as measured by eGFR, as well as safety and tolerability 1,14 . Novartis in kidney disease Building on a 40-year legacy that began in transplant, Novartis is on a mission to empower breakthroughs and transform care in kidney health, starting with kidney conditions that have significant unmet need. Historically, these conditions have had considerably less funding and research, leading to a treatment landscape largely focused on reactive or end-stage disease management, often with significant physical, emotional, and financial burdens. Our pipeline targets the underlying causes of disease, with an aim to protect kidney health and delay or prevent dialysis and/or transplantation. Our goal is to help patients get back to living life on their terms—whether at work, in school, or with loved ones, and by partnering with patients, advocates, clinicians and policymakers, we aim to raise awareness, accelerate diagnosis and get patients the right care, sooner. VANRAFIA Indications VANRAFIA is a prescription medicine used to reduce protein in the urine (proteinuria) in adults with a kidney disease called primary immunoglobulin A nephropathy (IgAN) who are at risk of their disease getting worse quickly. It is not known if VANRAFIA is safe and effective in children. VANRAFIA is approved based on a reduction of proteinuria. Continued approval may require results from an ongoing study to determine whether VANRAFIA slows decline in kidney function. Please see full Prescribing Information , including Boxed WARNING and Medication Guide . FABHALTA Indications FABHALTA is a prescription medicine used to: It is not known if FABHALTA is safe and effective in children with PNH, IgAN, or C3G. Please see full Prescribing Information , including Boxed WARNING and Medication Guide . About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and https://www.novartis.us and connect with us on LinkedIn , LinkedIn US , Facebook , X/Twitter , X/Twitter US and Instagram . References SOURCE: Novartis