Yeast infection

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.

Continued success of Cresemba® with 16.6% growth of royalties to CHF 42.8 million Operating result of CHF 9.3 million, net profit of CHF 20.7 millionTotal revenue guidance increased by 7% to CHF ~196 million and operating profit guidance increased by 20% to CHF ~36 million Ad hoc announcement pursuant to Art. 53 LR Allschwil, Switzerland, August 13, 2024 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 its results for the first half-year ended June 30, 2024. David Veitch, Chief Executive Officer, stated: “We have achieved several significant successes in 2024. Earlier this year, we obtained the approval of Zevtera in the US with a broad range of indications. We have been working towards securing a partnership for the commercialization of Zevtera in the US and are in negotiations with a number of potential partners. For Cresemba, the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, recommended extending the indications to include pediatric patients. We expect the formal decision by the European Commission still in the third quarter this year, which would not only bring Cresemba to this vulnerable patient population, but also extend the market exclusivity of Cresemba in the European Union by two years, until Q4 2027. Finally, we have made significant progress in the preparation of the phase 3 program for our potential next lead product, the broad-spectrum antifungal fosmanogepix, expecting to start the first phase 3 study, in invasive yeast infections, in the coming weeks.” Adesh Kaul, Chief Financial Officer, said: “We are pleased to report a positive operating result and net profit as well as positive cash flow for the first half year 2024. On the back of a strong H1 2024 financial performance, we have increased our financial guidance for the full year 2024, projecting that both revenue and profit will exceed our previous expectations. In addition to the continued growth in royalties and product revenues, we expect significant milestone payments related to our antifungal Cresemba in the second half of 2024, as compared to 2023, where they occurred in the first half of the year. Our increased guidance for 2024 considers the timelines for concluding a US commercialization partnership for Zevtera. Our financial strength enabled us to fully repay the remainder of the senior secured loan by the end of March and our positive financial prospects ensure that we can continue to invest into our pipeline and create value by implementing our strategy to become a leading anti-infectives company.” Financial summary For the first half year (H1) 2024, Basilea recognized total revenue of CHF 76.3 million (H1 2023: CHF 84.9 million). This included royalty income of CHF 42.8 million (H1 2023: CHF 36.7 million) from Cresemba, which increased by 16.6% year-on-year, and product revenue of CHF 27.6 million (H1 2023: CHF 13.2 million), which increased by 109% year-on-year. Milestone payments decreased to CHF 2.9 million (H1 2023: CHF 30.6 million) as most milestone events anticipated for 2024 are expected to be achieved in H2 2024, resulting in overall higher expected milestone payments for the full year (FY) 2024 as compared to FY 2023. Other revenue amounted to CHF 3.0 million (H1 2023: CHF 4.4 million). This included CHF 2.0 million BARDA reimbursements (H1 2023: CHF 2.0 million) for remaining activities related to the phase 3 program for ceftobiprole.1 In H1 2024, Basilea invested CHF 33.6 million (H1 2023: CHF 21.5 million) in research and development, driven by the preparations for starting the phase 3 program with fosmanogepix, the preclinical profiling of BAL2026 and tonabacase, the acquisition of the LptA inhibitor program, the remainder of the phase 3 ceftobiprole program and for research work on compounds in the Company’s early-stage portfolio. Selling, general and administrative expenses, including costs for the commercialization of Cresemba and Zevtera, decreased to CHF 15.3 million (H1 2023: CHF 16.5 million) and cost of products sold increased to CHF 18.1 million (H1 2023: CHF 10.0 million), reflecting the significant increase in product revenue. Basilea recorded an operating result of CHF 9.3 million (H1 2023: CHF 36.9 million). As a consequence of its sustained profitability and its positive mid-term financial outlook, the Company recognized deferred tax assets of CHF 13.4 million, which led to a net profit of CHF 20.7 million (H1 2023: CHF 31.8 million), resulting in a basic and diluted earnings per share of CHF 1.72 and CHF 1.61, respectively (H1 2023: basic and diluted earnings per share CHF 2.66 and CHF 2.42, respectively). In the first half of 2024, a positive net cash flow of CHF 17.9 million was provided by operating activities (H1 2023: CHF 21.9 million). The Company repaid the remaining CHF 15.6 million of a CHF 75.0 million senior secured loan by end of March 2024. Since 2022, Basilea reduced its debt by CHF 124 million, resulting in a net debt of CHF 26.2 million as of June 30, 2024 (June 30, 2023: CHF 38.1 million). Cash and cash equivalents and restricted cash amounted to CHF 69.5 million as of June 30, 2024 (June 30, 2023: CHF 112.9 million). Key financial figures (In CHF million, except per share data) H1 2024 H1 2023 Product revenue 27.6 13.2 Contract revenue 45.7 67.3 Other revenue 3.0 4.4 Total revenue 76.3 84.9 Cost of products sold (18.1) (10.0) Research & development expenses, net (33.6) (21.5) Selling, general & administrative expenses (15.3) (16.5) Total cost and operating expenses (67.0) (48.0) Operating result 9.3 36.9 Profit before taxes 7.3 31.9 Income taxes 13.4 (0) Net profit 20.7 31.8 Net cash provided by operating activities 17.9 21.9 Basic earnings per share, in CHF 1.72 2.66 Diluted earnings per share, in CHF 1.61 2.42 (in CHF million) June 30, 2024 June 30, 2023 Cash and cash equivalents and restricted cash 69.5 112.9 Note: Consolidated figures in conformity with US GAAP; rounding was applied consistently. The unaudited, condensed consolidated interim financial statements of Basilea Pharmaceutica Ltd, Allschwil for the first half year 2024 can be found on the company’s website at https://www.basilea.com/financial-reports. Increased 2024 financial guidance Basilea provides the following increased guidance for the full year 2024: Cresemba and Zevtera-related revenue is expected to grow by 26% to CHF ~190 million (FY 2023: CHF 150.3 million), reflecting the continued commercial success of Basilea’s commercialized products and the significant increase in milestone payments in H2 2024 as compared to H1 2024.Operating result is expected to increase by 88% to CHF ~36 million (FY 2023: CHF 19.2 million) and net profit is expected to increase by 300% to CHF ~42 million (FY 2023: CHF 10.5 million). (In CHF million) FY 2024e(new) FY 2024e(previous) FY 2023 Cresemba and Zevtera-related revenue ~190 ~180 150.3 of which royalty income ~92 ~89 78.9 Total revenue ~196 ~183 157.6 Cost of products sold ~40 ~33 26.8 Operating expenses ~120 ~120 111.7 Operating result ~36 ~30 19.2 Net profit ~42 ~25 10.5 Organizational update As per August 1, 2024, Dr. Mark Jones, Head of Global Affairs, and Raimond Grewenig-Scheurich, Head of Global Commercial, have been appointed to Basilea’s extended management committee. Conference call and webcast Basilea Pharmaceutica Ltd, Allschwil will host a conference call and webcast today, Tuesday, August 13, 2024, at 4 p.m. (CEST), to discuss the company’s financial and operating results and to provide an outlook. Via audio webcast with presentation The live audio webcast of the results presentation can be followed here: https://event.choruscall.com/mediaframe/webcast.html?webcastid=JQX4uI0E. Please note that there is no function to ask questions via webcast. For questions, please additionally dial-in via phone (see below). Via phone To listen by phone and ask questions, please use the dial-in details below. To ensure prompt access, please call approximately five minutes prior to the scheduled start of the call. +41 (0) 58 310 5000(Switzerland, Europe and RoW)+1 (1) 866 291 4166(USA)+44 (0) 207 107 0613(UK) Replay The webcast, along with the presentation will be available online (same link as live audio webcast above) shortly after the event and accessible for three months. 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.cominvestor_relations@basilea.com This ad hoc announcement can be downloaded from www.basilea.com. References 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 work. Attachment Press release (PDF)

A new study suggests that adding common bone loss drugs to azoles can improve efficacy when treating fungal infections. Human skin, hair and nails are all vulnerable to fungal infections. While these infections are usually not serious, they're difficult to fully resolve and often recur after treatment -- sometimes for years. They're also often resistant to treatments, including a common class of antifungals called azoles. A study published this week in mSphere points to a new way to boost the efficacy of azoles in treating those infections -- combining them with commonly available drugs called bisphosphonates, usually used to treat osteoporosis. Previous work by the same research group has shown that adding bisphosphonates to azoles can effectively treat yeast infections from Candida and Cryptococcus species. The new study extends that finding to dermatophytes, which cause superficial infections. The study suggests that bisphosphonates could be repurposed to use with azole antifungals, which are relatively nontoxic, and that the combination could be readily tested in clinical studies. "There aren't many good antifungal drugs around, and the fungus will always develop resistance no matter how you treat them," said senior author Dee Carter, a mycologist at the University of New South Wales, Australia. "For what we're proposing, to use 2 drugs at the same time, that resistance is much less likely." Carter says she was only a little surprised to see the synergistic effect in dermatophytes. This research project began years ago, she says, when her group conducted a series of genomic analyses on the response of pathogenic yeasts to drug treatment. That study led them to a genetic pathway that is "upstream" of the pathway targeted by azoles, and is instead targeted by bisphosphonates. "That's often a good way to get drugs to work, is to target processes that are interlinked like that," Carter said. In the lab, Carter and her team tested 3 commonly available bisphosphonates (risedronate, alendronate and zoledronate) in combination with 3 commonly available azole antifungals (fluconazole, itraconazole and ketoconazole). They tested these against clinical isolates from a diverse range of dermatophyte species that cause superficial infections. The combination of zoledronate and ketoconazole proved particularly effective against 8 of the 9 tested species. It also prevented the development of resistance. Aidan Kane, mycologist, lead author of the study and a Ph.D. student in Carter's lab, used fluorescence microscopy and other methods to show that the drug combination worked by weakening the cell membrane enough that the fungus could not survive. Beyond the dermatophytes, the group also found that bisphosphonate-azole combinations could act against molds that cause invasive disease, suggesting another possible clinical application for the drugs. "You can use these combinations directly for superficial infections, like Candida or dermatophyte infections, and we're hoping that with modified forms of the drugs we can create something that will also work systematically," Carter said. "The next step is to continue testing bisphosphonate-azole combinations in animal models, and then test it in clinical trials."