Staphylococcus aureus bacteraemia

LOS ANGELES, Aug. 26, 2024 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on the development of high-purity, pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, today announced that Mina Pastagia, M.D., MS, Chief Medical Officer, will deliver a poster presentation at the 2024 Military Health System Research Symposium (MHSRS), which is being held August 26-29 in Kissimmee, FL. The poster provides an overview of Armata's two distinct phage development programs, inhaled AP-PA02 (Pseudomonas aeruginosa bronchiectasis) and intravenous AP-SA02 (Staphylococcus aureus (S. aureus) bacteremia), which are being or have been evaluated in three distinct double-blind, placebo-controlled Phase 2 clinical trials. Regarding AP-SA02, Armata is currently advancing its Phase 1b/2a multiple ascending dose study (diSArm) of intravenous AP-SA02 as an adjunct to best available antibiotic therapy (BAT) compared to BAT alone. Enrollment of the diSArm study is 80% complete, and Armata anticipates completing enrollment by the end of 2024. The clinical development of AP-SA02 is supported by a $21.6 million Department of Defense grant, received through the Medical Technology Enterprise Consortium (MTEC) and managed by the Naval Medical Research Command (NMRC) – Naval Advanced Medical Development (NAMD) with funding from the Defense Health Agency and Joint Warfighter Medical Research Program. "We are excited to participate in this year's MHSRS and highlight the rigorously designed double-blind, placebo-controlled clinical trials that we are executing for both of our phage candidates," stated Dr. Pastagia. "Through our completed and ongoing Phase 2 trials, our phage candidates have been well tolerated, allowing us to evaluate higher phage doses that can increase the ability of our phages to fulfill their mechanism of action of attacking only pathogenic bacteria. This in turn is expected to provide Armata with the necessary data to inform how best to administer phage therapy and decrease the usage of broad-spectrum antibiotics so as to preserve the human microbiome in an effort to lower patient morbidity. We greatly appreciate the collaborative partnership with the NMRC and NAMD as well as MTEC for its financial support of our AP-SA02 program. We look forward to advancing both AP-SA02 and AP-PA02 into pivotal Phase 3 trials next year with the hope of introducing a distinct new class of anti-infectives to patient care." Summary: Multiple-dose administration of intravenous AP-SA02 and inhaled AP-PA02 have been well tolerated to date. Preliminary pharmacokinetic data suggests intravenous AP-SA02 is active in all subjects, with longer phage persistence in a significant subset of subjects potentially demonstrating a persistent reservoir of S. aureus bacteria (despite antibiotics) and in vivo amplification of the phages. This may garner increased clinical benefit for patients with difficult-to-treat S. aureus infections. Preliminary evidence supports inhaled AP-PA02 monotherapy as a viable alternative to inhaled antibiotics in Pseudomonas aeruginosa bronchiectasis. Promising data for both phage candidates is expected to be utilized for planning pivotal Phase 3 clinical trials in 2025. About MHSRS The MHSRS is the Department of Defense's foremost scientific meeting. It provides a venue for presenting new scientific knowledge resulting from military-unique research and development. The MHSRS is the premier military or civilian meeting that focuses specifically on the unique medical needs of the warfighter. The MHSRS provides a collaborative setting for the exchange of information between military providers with deployment experience, research and academic scientists, international partners, and industry on research and related health care initiatives falling under the topic areas of Combat Casualty Care, Military Operational Medicine, Clinical and Rehabilitative Medicine, Information Sciences, Military Infectious Diseases, and Radiation Health Effects. About Armata Pharmaceuticals, Inc. Armata is a clinical-stage biotechnology company focused on the development of pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. Armata is committed to advancing phage therapy with drug development expertise that spans bench to clinic including in-house phage specific cGMP manufacturing. Forward Looking Statements This communication contains "forward-looking" statements as defined by the Private Securities Litigation Reform Act of 1995. These statements relate to future events, results or to Armata's future financial performance and involve known and unknown risks, uncertainties and other factors which may cause Armata's actual results, performance or events to be materially different from any future results, performance or events expressed or implied by the forward-looking statements. In some cases, you can identify these statements by terms such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" or the negative of those terms, and similar expressions. These forward-looking statements reflect management's beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this communication and are subject to risks and uncertainties including risks related to Armata's development of bacteriophage-based therapies; ability to staff and maintain its production facilities under fully compliant current Good Manufacturing Practices; ability to meet anticipated milestones in the development and testing of the relevant product; ability to be a leader in the development of phage-based therapeutics; ability to achieve its vision, including improvements through engineering and success of clinical trials; ability to successfully complete preclinical and clinical development of, and obtain regulatory approval of its product candidates and commercialize any approved products on its expected timeframes or at all; and Armata's estimates regarding anticipated operating losses, capital requirements and needs for additional funds. Additional risks and uncertainties relating to Armata and its business can be found under the caption "Risk Factors" and elsewhere in Armata's filings and reports with the SEC, including in Armata's Annual Report on Form 10-K, filed with the SEC on March 21, 2024, and in its subsequent filings with the SEC. Armata expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Armata's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. Media Contacts: At Armata: Pierre Kyme Armata Pharmaceuticals, Inc. [email protected] 310-665-2928 x234 Investor Relations: Joyce Allaire LifeSci Advisors, LLC [email protected] 212-915-2569 SOURCE Armata Pharmaceuticals, Inc.

LOS ANGELES, Aug. 13, 2024 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a biotechnology company focused on high-purity, pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, today announced financial results for its second quarter ended June 30, 2024, and provided a corporate update. Second Quarter 2024 and Recent Developments: Announced completion of enrollment in its Tailwind Phase 2 clinical study of inhaled AP-PA02 in patients with Non-Cystic Fibrosis Bronchiectasis (NCFB) and chronic pulmonary Pseudomonas aeruginosa (P. aeruginosa) infection. The last patient final follow-up visit occurred on August 7. Armata anticipates topline data from the Tailwind study in the second half of 2024. Received $5.25 million of additional non-dilutive funding from the U.S. Department of Defense pursuant to a previously-announced grant. The award is partially supporting advancement of the Phase 2a portion of the diSArm study of intravenous AP-SA02 as a potential treatment for Staphylococcus aureus (S. aureus) bacteremia. Further advanced bacteriophage science through presentations and publications: Delivered a presentation on advancing bacteriophage therapy at Viruses of Microbes 2024, which was held July 15-19, 2024, in Cairns, Australia. Completed the build-out of its advanced biologics manufacturing facility with five current good manufacturing practice ("cGMP") clean rooms, including a state-of-the-art automated fill and finish suite. "During the second quarter and subsequent period, we made meaningful progress across both of our clinical programs, keeping us on track to potentially initiate pivotal studies next year," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "Regarding AP-PA02, which we are developing as an inhaled treatment for chronic P. aeruginosa lung infections, I am pleased to report that we recently completed enrollment and the last patient visit in our Phase 2 Tailwind study in subjects with NCFB, and we plan to announce topline data later this year." "For AP-SA02, we continued to advance our Phase 2a diSArm study of intravenous AP-SA02 as a potential treatment for S. aureus bacteremia. We are grateful to the Department of Defense for its ongoing financial support, which provides us with critical non-dilutive funding. We look forward to completing the diSArm study later this year and identifying the optimal dose of AP-SA02 to be tested in a larger definitive study." "Also, during the second quarter, we completed the build-out of our state-of-the-art cGMP manufacturing facility, giving us the ability to support our late-stage clinical trials, potential partnerships, and potential commercial production." "Our mission has long been the execution of rigorously designed, randomized clinical studies that demonstrate the safety and efficacy of our multi-phage candidates to support eventual registration, and I am very pleased with our sustained progress during the second quarter and through the first half of the year," Dr. Birx concluded. Second Quarter 2024 Financial Results Grant Revenue. The Company recognized no grant revenue for the three months ended June 30, 2024. The Company recognized approximately $1.0 million of grant revenue in the comparable period in 2023 which represents Medical Technology Enterprise Consortium's share of the costs incurred for the Company's AP-SA02 program for the treatment of Staphylococcus aureus bacteremia. Research and Development. Research and development expenses for the three months ended June 30, 2024 were approximately $8.5 million as compared to approximately $8.3 million for the comparable period in 2023. The Company continues to invest in clinical related expenses associated with its primary development programs. General and Administrative. General and administrative expenses for the three months ended June 30, 2024 were approximately $3.4 million as compared to approximately $2.4 million for the comparable period in 2023. The increase was mainly related to an increase of $1.0 million in stock-based compensation as a result of increased awards granted during the first quarter of 2024. Loss from Operations. Loss from operations for the three months ended June 30, 2024 was $11.9 million as compared to a loss from operations of approximately $9.6 million for the comparable period in 2023. Cash and Equivalents. As of June 30, 2024, Armata held approximately $26.4 million of unrestricted cash and cash equivalents, as compared to $13.5 million as of December 31, 2023. As of August 13, 2024, there were approximately 36.2 million common shares outstanding. About Armata Pharmaceuticals, Inc. Armata is a clinical-stage biotechnology company focused on the development of pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. Armata is committed to advancing phage therapy with drug development expertise that spans bench to clinic including in-house phage specific cGMP manufacturing. Forward Looking Statements This communication contains "forward-looking" statements as defined by the Private Securities Litigation Reform Act of 1995. These statements relate to future events, results or to Armata's future financial performance and involve known and unknown risks, uncertainties and other factors which may cause Armata's actual results, performance or events to be materially different from any future results, performance or events expressed or implied by the forward-looking statements. In some cases, you can identify these statements by terms such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" or the negative of those terms, and similar expressions. These forward-looking statements reflect management's beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this communication and are subject to risks and uncertainties including risks related to Armata's development of bacteriophage-based therapies; ability to staff and maintain its production facilities under fully compliant current Good Manufacturing Practices; ability to meet anticipated milestones in the development and testing of the relevant product; ability to be a leader in the development of phage-based therapeutics; ability to achieve its vision, including improvements through engineering and success of clinical trials; ability to successfully complete preclinical and clinical development of, and obtain regulatory approval of its product candidates and commercialize any approved products on its expected timeframes or at all; and Armata's estimates regarding anticipated operating losses, capital requirements and needs for additional funds. Additional risks and uncertainties relating to Armata and its business can be found under the caption "Risk Factors" and elsewhere in Armata's filings and reports with the SEC, including in Armata's Annual Report on Form 10-K, filed with the SEC on March 21, 2024, and in its subsequent filings with the SEC. Armata expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Armata's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. Media Contacts: At Armata: Pierre Kyme [email protected] 310-665-2928 Investor Relations: Joyce Allaire LifeSci Advisors, LLC [email protected] 212-915-2569 SOURCE Armata Pharmaceuticals, Inc.

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)