Fosmanogepix

Plus, news about Apollo Therapeutics, Reunion Neuroscience, Basilea, Tafalgie Therapeutics, Areteia Therapeutics and Avidity Biosciences: 🇨🇳 Two more biotechs look to IPO in Hong Kong: Ark Biopharmaceutical in Shanghai and Atom Therapeutics in Hangzhou joined the queue of Chinese drug developers looking to go public on the Hong Kong Stock Exchange. Founded in 2013, ArkBio is waiting for approval in China next year for an RSV treatment and a small molecule for ADHD. It also has programs in development for IPF , COPD and influenza and has in-licensed candidates from Roche and Commave Therapeutics. Meanwhile, Atom has treatments for various forms of gout , hyperuricemia and chronic kidney disease in late- and mid-stage trials. — Kyle LaHucik 🔬 Aptevo Therapeutics’ stock jumps on early AML data: The Seattle company reported a 100% remission rate in six newly diagnosed AML patients who received mipletamig, its CD123xCD3 bispecific, on top of the standard treatments of AbbVie and Roche’s Venclexta and azacitidine. These patients were given the highest dose (27 mcg) thus far of mipletamig in the Phase 1b/2 trial. Aptevo said no cases of cytokine release syndrome have been reported in frontline patients treated with its drug. The biotech’s shares $APVO jumped about 30% Tuesday morning. — Lei Lei Wu ✅ Apollo Therapeutics shares mid-stage atopic dermatitis data: The biotech’s IL-18 targeting antibody, called camoteskimab, produced a statistically significant reduction in the eczema area and severity index versus placebo at 16 weeks. Scores for the two arms were “clearly separated” at four weeks. Apollo plans to share detailed results at an upcoming scientific conference. — Ayisha Sharma 🧠 Reunion Neuroscience gets $30M Series A extension: The additional cash brings the total amount raised to $133 million. Reunion said the money will help fund a Phase 2 study in adjustment disorder in cancer and other diseases, while also supporting the launch of a separate trial for generalized anxiety disorder. — Max Gelman 🦠 Basilea gets $25M from BARDA: The company is developing a pair of antifungal treatments: fosmanogepix and BAL2062. It’s evaluating fosmanogepix in yeast infections and both drugs for mold infections. — Jaimy Lee 💶 Non-opioid pain biotech secures €12 million in Series A: Tafalgie Therapeutics, based in Marseille, plans to use the proceeds to advance its lead pain candidate, TT5, through Phase 2a development, according to a release emailed to Endpoints News . TT5 is a peptide derivative of a naturally occurring protein called TAFA4, which modulates pain signals as they move between the peripheral and central nervous systems. — Ayisha Sharma 🫁 Areteia Therapeutics toplines Phase 3 trial in eosinophilic asthma: The company studied an oral drug called dexpramipexole, which improved patients’ lung function by a statistically significant margin compared to placebo. Researchers averaged lung function measurements after 20 and 24 weeks. No specific figures were disclosed. — Max Gelman 💰 Avidity Biosciences ended up raising $690 million in its public offering. — Jaimy Lee

Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, September 16, 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, announced today that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services, committed the next USD 25 million to Basilea to continue to advance the development of Basilea’s novel antifungals fosmanogepix and BAL2062. This additional funding follows the achievement of a prespecified enrollment milestone in the fosmanogepix phase 3 study in candidemia/invasive candidiasis within the “Other Transaction Agreement” (OTA, agreement number 75A50124C00033), which allows for potential total funding of up to approximately USD 268 million to develop antifungal and antibacterial assets. David Veitch, Chief Executive Officer of Basilea, said: “We are very pleased with the continued funding under the OTA with BARDA to support the development of our antifungal drug candidates fosmanogepix and BAL2062. These compounds, with novel mechanisms of action, promise new therapeutic options for patients with aspergillosis, candidiasis or other life-threatening invasive fungal infections. There continues to be a high medical need for new innovative antifungal treatments.” He added: “This third tranche of funding within the BARDA OTA will support our two ongoing phase 3 studies with fosmanogepix in yeast infections and in mold infections. It also provides further funding for the phase 2 development of BAL2062 in mold infections.” The USD 25 million is in addition to the USD 68 million already committed by BARDA since the signing of the OTA in September 2024. BARDA’s financial contribution is about 60% of the total costs of the supported projects over the term of the OTA, which could provide a total potential non-dilutive funding of up to approximately USD 268 million, over up to 12 years, if all additional options to extend the contract are exercised by BARDA, upon successful completion of pre-defined milestones, including clinical and regulatory activities. About fosmanogepix Fosmanogepix is a clinical-stage broad-spectrum antifungal. It has a novel mechanism of action and its active moiety has shown activity against common species of Candida and Aspergillus, including multi-drug-resistant strains, such as Candida auris and Candida glabrata, as well as rare difficult-to-treat molds including Fusarium spp., Scedosporium spp., and some fungi from the Mucorales order.1 Fosmanogepix intravenous and oral formulations have been evaluated in clinical phase 2 studies for the treatment of patients with Candidemia, including Candida auris infections, and invasive mold infections.1 The FAST study, a phase 3 study evaluating fosmanogepix in the treatment of adult patients with candidemia and/or invasive candidiasis and the FORWARD study, a phase 3 study, in the treatment of adult patients with invasive mold infections, are ongoing.2 Fosmanogepix has received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration for a number of indications, and is designated as a Qualified Infectious Disease Product (QIDP). About BAL2062 BAL2062 is a first-in-class antifungal, derived from a natural product, and has demonstrated fungicidal activity against clinically important molds such as Aspergillus spp., including azole-resistant strains.3 Safety and tolerability have been demonstrated in a previously completed phase 1 study with single and multiple ascending intravenous (i.v.) doses.4 The drug candidate has Qualified Infectious Disease Product (QIDP), Orphan Drug and Fast Track designation from the US Food and Drug Administration (FDA) for invasive aspergillosis. About invasive mold infections Invasive aspergillosis and invasive infections with rare molds (e.g., Fusarium spp., Scedosporium spp., and Mucorales fungi) are life-threatening infections that predominantly affect immunocompromised patients, including patients with hematologic malignancies (blood cancer), transplant patients, or patients with other immunodeficiency disorders. These infections are associated with high morbidity and mortality.5, 6 About invasive candidiasis Invasive candidiasis, including deep-seated tissue candidiasis and candidemia, is an increasingly important nosocomial infection, especially in patients hospitalized in intensive care units. Candida species are ranked as the fourth main cause of bloodstream infections in hospitals in the US.7 The prognosis of invasive candidiasis remains difficult, with a reported mortality rate for invasive candidiasis as high as 40%, even when patients receive antifungal therapy.8 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. This project has been funded in part with federal funds from the U.S. Department of Health and Human Services (HHS); Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under OT number: 75A50124C00033. The contract and federal funding are not an endorsement of the study results, product, or company. 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 ad hoc announcement can be downloaded from www.basilea.com. References K. J. Shaw, A. S. Ibrahim. Fosmanogepix: A Review of the First-in-Class Broad Spectrum Agent for the Treatment of Invasive Fungal Infections. Journal of Fungi (Basel) 2020 (6), 239FAST study (candidemia/invasive candidiasis): ClinicalTrials.gov identifier NCT05421858; FORWARD study (invasive mold infections): ClinicalTrials.gov identifier NCT06925321K. J. Shaw. GR-2397: Review of the Novel Siderophore-like Antifungal Agent for the Treatment of Invasive Aspergillosis. Journal of Fungi (Basel) 2022 (8), 909ClinicalTrials.gov identifier NCT02956499: M. P. Mammen, D. Armas, F. H. Hughes et al. First-in-Human Phase 1 Study To Assess Safety, Tolerability, and Pharmacokinetics of a Novel Antifungal Drug, VL-2397, in Healthy Adults. Antimicrobial Agents and Chemotherapy 2019 (63), e00969-19J. Cadena, G. R. Thompson 3rd, T. F. Patterson. Aspergillosis: Epidemiology, Diagnosis, and Treatment. Infectious Disease Clinics of North America 2021 (35), 415-434M. Slavin, S. van Hal, T. C. Sorrell et al. Invasive infections due to filamentous fungi other than Aspergillus: epidemiology and determinants of mortality. Clinical Microbiology and Infection 2015 (21), 490.e1-490.e10Candidemia (Blood Infection) and Other Candida Infections. 2019 Factsheet by the American Thoracic Society: https://www.thoracic.org/patients/patient-resources/resources/candidemia.pdf (Accessed: September 15, 2025)B. J. Kullberg, M. C. Arendrup. Invasive Candidiasis. The New England Journal of Medicine 2015 (373), 1445-1456 Attachment Press release (PDF)