Yeast infection

Allschwil, Switzerland, January 08, 2025 Basilea Pharmaceutica Ltd, Allschwil (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, reported today on the progress of its Research & Development portfolio in 2024 and upcoming milestones. David Veitch, Chief Executive Officer, said: “We have achieved several significant milestones in 2024. We partnered with a highly committed, focused and capable company for the commercialization of our anti-MRSA antibiotic, Zevtera, in the United States, following its approval earlier in the year. For our leading antifungal Cresemba, the European Commission expanded the approved uses to include treatment for pediatric patients. This not only made Cresemba available to children, but also extended its protection from generic competition in the EU until late 2027. We are also pleased to have been awarded very significant non-dilutive funding from BARDA and CARB-X to support the development of novel, first-in-class antifungals and antibacterials within our R&D portfolio. Finally, we laid the foundation for future growth by commencing a phase 3 study in invasive yeast infections with our potential next lead product, the broad-spectrum antifungal fosmanogepix. Throughout 2025, we aim to continue both progressing our current R&D assets and expanding our portfolio through targeted in-licensing and acquisition of innovative, commercially attractive, pre-clinical and clinical assets, addressing unmet medical needs in the treatment of severe fungal and bacterial diseases.” Maintaining its strong momentum, the commercial performance of Cresemba triggered several milestone payments to Basilea in 2024. By year-end 2024, Cresemba was marketed in more than 70 countries, including the United States (US), most EU member states, China and Japan. According to the latest available market data, total global in-market sales of Cresemba in the twelve-month period between October 2023 and September 2024 amounted to USD 533 million, a 20 percent growth year-on-year, making it the largest branded antifungal for invasive fungal infections worldwide.1 Portfolio key highlights 2024 and outlook 2025 Cresemba® (isavuconazole): Indications expanded to pediatric patients In August, the European Commission approved the use of Cresemba in children with invasive aspergillosis or mucormycosis,2 following a similar decision by the US Food and Drug Administration (FDA) in December 2023; the market exclusivity of Cresemba was extended to October 2027 in the EU and September 2027 in the US. Zevtera® (ceftobiprole): US approval and commercialization progress; Chinese NRDL inclusion In April, the US FDA approved Zevtera for SAB, ABSSSI and CABP, i.e. all three submitted indications.3, 4In September, Zevtera has been approved for New-Technology Add-On Payment (NTAP) in the US, which will provide hospitals an incremental payment in addition to standard reimbursement, by the Centers for Medicare & Medicaid Service (CMS).5In December, we announced Innoviva Specialty Therapeutics (IST) as commercialization partner for the US market. The US launch is expected mid-2025.In China, ceftobiprole (Chinese trade name: Sibipre®) has been included in the National Reimbursement Drug List (NRDL) at the end of 2024, making it eligible for reimbursement under the Chinese national basic medical insurance program from 2025. Clinical and preclinical pipeline: Substantial progress made and significant funding secured The “Other Transaction Agreement” (OTA)6 with the Biomedical Advanced Research and Development Authority (BARDA) signed in September provides up to approximately USD 268 million non-dilutive funding over up to 12 years for the development of novel antifungals and antibacterials. An initial commitment of USD 29 million supports the development of our antifungals fosmanogepix and BAL2062.In September, we commenced a phase 3 study with fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis, i.e. severe invasive yeast infections. A second phase 3 study, in invasive mold infections, is expected to start in the coming months.The Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) awarded non-dilutive funding of USD 7.3 million in December for the first-in-class LptA inhibitor antibiotic, BAL2420, which we acquired in January 2024.7 This was new funding on top of USD 0.9 million awarded in April. The extended funding supports the progression of the drug candidate towards a first-in-human clinical study which is expected to start mid-2026. BAL2420 is being developed for the potential treatment of severe infections caused by Gram-negative bacteria.Preclinical evaluations for the antibacterial tonabacase and the antifungal BAL2062 are well advanced. We expect to take the decision whether to exercise our option to initiate exclusive contract negotiations to license tonabacase for further clinical development and commercialization in the next few weeks. For BAL2062, our focus in 2025 will be on the completion of the preclinical profiling and the preparation of the phase 2 program so that we can start the clinical study in early 2026. About Basilea Basilea is a commercial-stage biopharmaceutical company founded in 2000 and headquartered in Switzerland. We are committed to discovering, developing and commercializing innovative drugs to meet the needs of patients with severe bacterial and fungal infections. We have successfully launched two hospital brands, Cresemba for the treatment of invasive fungal infections and Zevtera for the treatment of bacterial infections. In addition, we have preclinical and clinical anti-infective assets in our portfolio. Basilea is listed on the SIX Swiss Exchange (SIX: BSLN). Please visit basilea.com. Disclaimer This communication expressly or implicitly contains certain forward-looking statements, such as "believe", "assume", "expect", "forecast", "project", "may", "could", "might", "will" or similar expressions concerning Basilea Pharmaceutica Ltd, Allschwil and its business, including with respect to the progress, timing and completion of research, development and clinical studies for product candidates. Such statements involve certain known and unknown risks, uncertainties and other factors, which could cause the actual results, financial condition, performance or achievements of Basilea Pharmaceutica Ltd, Allschwil to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Basilea Pharmaceutica Ltd, Allschwil is providing this communication as of this date and does not undertake to update any forward-looking statements contained herein as a result of new information, future events or otherwise. For further information, please contact: Peer Nils Schröder, PhD Head of Corporate Communications & Investor RelationsBasilea Pharmaceutica International Ltd, Allschwil Hegenheimermattweg 167b4123 AllschwilSwitzerland Phone +41 61 606 1102 E-mail media_relations@basilea.com investor_relations@basilea.com This press release can be downloaded from www.basilea.com. References IQVIA Analytics Link, September 2024. In-market sales reported as moving annual total (MAT) in US dollar.European Public Assessment Report (EPAR): https://www.ema.europa.eu/en/medicines/human/EPAR/cresemba [Accessed: January 07, 2025]Full US prescribing information: https://www.basilea.com/ZEVTERA_US_prescribing_information_46b9y4wk; SAB: Staphylococcus aureus bacteremia; ABSSSI: Acute bacterial skin and skin structure infections; CABP: Community-acquired bacterial pneumonia.Basilea’s ceftobiprole phase 3 program is funded in part with federal funds from the US Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under contract number HHSO100201600002C. Basilea has been awarded approximately USD 112 million, or approximately 75 percent of the costs related to the Staphylococcus aureus bacteremia (SAB) and acute bacterial skin and skin structure infections (ABSSSI) phase 3 studies, regulatory activities and non-clinical workDepartment of Health and Human Services, Centers for Medicare & Medicaid Services: Medicare and Medicaid Programs and the Children's Health Insurance Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Policy Changes and Fiscal Year 2025 Rates; Quality Programs Requirements; and Other Policy Changes: https://federalregister.gov/d/2024-17021 (Accessed: January 07, 2025)BARDA OTA number: 75A50124C00033CARB-X’s funding for this project is provided in part with federal funds from the US Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority; Antibacterials branch; under agreement number 75A50122C00028; and by awards from Wellcome (WT224842) and Germany’s Federal Ministry of Education and Research (BMBF). The content of this press release is solely the responsibility of the authors and does not necessarily represent the official views of CARB-X or any of its funders. Attachment 20250108_Basilea Press release_Portfolio status update_EN.pdf

MARLBOROUGH, Mass.--( BUSINESS WIRE )--A new study published in JAMA Network Open titled “ Income-Related Disparities in Mortality Among Young Adults With Type 2 Diabetes ” underscores the need for addressing disparities in care and improving access to important therapies for type 2 diabetes. This study further underscores recent data compiled by the American Diabetes Association which states that diabetes is the most expensive chronic condition in the United States, and millions of Americans struggle to afford effective treatment of their type 2 diabetes and associated complications. Seeking to address this critical health issue, BRENZAVVY ® (bexagliflozin) is a safe, effective and affordable option for adults with type 2 diabetes. In the United States, BRENZAVVY is sold at around $50 per month through a network of online and independent pharmacies. BRENZAVVY's low price point makes sodium-glucose cotransporter 2 (SGLT2) inhibitor therapy a more affordable option for uninsured, underinsured, and Medicare patients. This increased affordability can help ensure that patients can initiate and maintain a safe and effective therapy, improving their ability to manage their type 2 diabetes. Adults with type 2 diabetes can easily determine if BRENZAVVY is right for them by visiting www.brenzavvydirect.com and speaking to a doctor quickly and affordably. For healthcare providers, BRENZAVVY can easily be prescribed without insurance plan headaches, such as prior authorizations or step therapy hurdles, that the SGLT2 inhibitor class traditionally faces. “ The findings of this study reinforce that many adults living with type 2 diabetes simply cannot afford to start and stay on their therapy ,” said the TheracosBio CEO, Brian Connelly. “ With BRENZAVVY, TheracosBio is fulfilling our mission to address financial barriers to care. By unlocking wider access to an important class of therapy, more and more people with type 2 diabetes have better access to a safe, affordable and effective treatment option,” Mr. Connelly added. BRENZAVVY is available as 20 mg oral tablets to be taken once daily, in the morning, with or without food. Phase 3 clinical studies have shown BRENZAVVY significantly reduces hemoglobin A1c and fasting blood sugar after 24 weeks, either as a monotherapy, in combination with metformin, or as an add-on to standard-of-care treatment consisting of a variety of regimens, including metformin, sulfonylureas, insulin, DPP4 inhibitors or combinations of these agents. Although BRENZAVVY is not approved for weight loss or blood pressure reduction, modest decreases in both weight and blood pressure have been observed in the clinical program. To learn more about BRENZAVVY , please visit https://www.brenzavvy.com . To learn more about TheracosBio, please visit https://theracosbio.com . BRENZAVVY Important Safety Information BRENZAVVY ® (bexagliflozin) is a prescription medicine used along with diet and exercise to improve blood sugar in adults with type 2 diabetes. BRENZAVVY is not recommended to decrease blood sugar in people with type 1 diabetes. Do not take BRENZAVVY if you are allergic to bexagliflozin or any of the ingredients in BRENZAVVY. BRENZAVVY can cause serious side effects including diabetic ketoacidosis that may be fatal. Signs and symptoms of ketoacidosis include nausea, vomiting, stomach pains, tiredness, trouble breathing, and ketones in urine or blood. Ketoacidosis can happen even if your blood sugar is less than 250 mg/dL. BRENZAVVY may increase the risk of lower limb amputations. Call your doctor if you notice signs or symptoms. Amputations mainly involve removal of the toe or part of the foot, however, amputations involving the leg, below and above the knee, have also occurred. Some people had more than one amputation. BRENZAVVY may cause dehydration, urinary tract or genital yeast infections, and low blood sugar. Symptoms of dehydration include feeling dizzy, faint, lightheaded, or weak upon standing. Yeast infections can occur in women and men. Signs of low blood sugar may include headache, confusion, drowsiness, dizziness, sweating, irritability, hunger, shaking, fast heartbeat, or weakness. A rare life-threatening bacterial infection in the skin of the perineum could occur. Stop taking BRENZAVVY and call your doctor right away if you have symptoms of this infection The perineum is the area between the anus and genitals. Symptoms of this infection include fever, weakness and pain tenderness, redness, or swelling of the genital area. The most common side effects of BRENZAVVY are vaginal yeast infections, urinary tract infections, and changes in urination, including an urgent need to urinate more often, in large amounts, and at night. For additional important safety information about BRENZAVVY, visit www.brenzavvy.com . About TheracosBio TheracosBio was founded in 2000 and develops affordably priced novel therapeutics for diseases with significant societal impact. The mission of TheracosBio is to expand access to new medications for patients with common diseases. COM-23118-01

In the near term, Basilea Pharmaceutica will get $29 million to develop its antifungals fosmanogepix and BAL2062. Basilea Pharmaceutica’s work developing new antifungals has received a significant boost from the U.S. Department of Health and Human Services, which has signed off on up to $268 million of funding to the Swiss company over more than a decade.The agreement with the Biomedical Advanced Research and Development Authority (BARDA) will see the funding spread over up to 12 years to “support the development of designated novel, first-in-class antifungals and antibacterials in Basilea’s portfolio,” the company explained in a Sept. 19 release. Receiving the full $268 million will be dependent on Basilea hitting a series of clinical and regulatory milestones as well as BARDA choosing to extend the contract.In the near term, the company will get $29 million to develop its antifungals fosmanogepix and BAL2062. The biotech is lining up fosmanogepix—which originates at Amplyx Pharmaceuticals but which Basilea acquired from Pfizer last year—for a phase 3 trial in invasive yeast infections, while BAL2062—which was bought from Gravitas Therapeutics—has completed a phase 1 safety study and is being aimed at molds like Aspergillus.The nature of the funding agreement means BARDA and Basilea can together decide which candidates to move in and out of the remit “based on product performance, technical risk, and programmatic need.” Basilea’s relationship with BARDA stretches back to 2013 when the agency committed $89 million in funding toward the antibiotic BAL30072—although the biotech went on to scrap the candidate three years later.Basilea CEO David Veitch said today’s agreement “will be leveraging our strong portfolio and the capabilities of our organization to develop urgently needed novel antifungals and antibacterials.”“We believe this long-term partnership will also lead to the successful implementation of our strategy to become a leading anti-infectives company,” Veitch added.Basilea currently markets Cresemba for invasive fungal infections and Zevtera for bacterial infections. The low return on investment means many of the biggest biopharmas have given up working on new antifungals or antibiotics in recent years—although GSK in particular has continued to sign deals and post encouraging clinical results against infections like gonorrhea.Meanwhile, Basilea has swum against the tide, pivoting away from cancer toward anti-infectives last year.