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Armata Pharmaceuticals, Inc. (NYSE American: ARMP) is a clinical-stage biotechnology company dedicated to developing pathogen-specific bacteriophage therapeutics to address antibiotic-resistant and challenging bacterial infections. Utilizing proprietary bacteriophage-based technology, Armata is advancing a broad pipeline of both natural and synthetic phage candidates targeting critical pathogens such as Pseudomonas aeruginosa and Staphylococcus aureus.
Armata's innovative approach includes developing clinical candidates like AP-PA02 and AP-SA02. AP-PA02, a five-phage cocktail, is aimed at treating Pseudomonas aeruginosa infections, particularly in people with cystic fibrosis. The company is currently analyzing data from its SWARM-P.a. study to progress into a Phase 2b/3 registrational study in 2024. Meanwhile, AP-SA02, designed to combat Staphylococcus aureus bacteremia, has shown positive results in Phase 1b trials and is moving into Phase 2a with support from the U.S. Department of Defense.
In collaboration with Merck, Armata is developing proprietary synthetic phage candidates to address other significant infectious diseases. The company’s commitment to innovation extends to its in-house phage-specific GMP manufacturing capabilities, ensuring high-quality production from bench to clinic.
Financially, Armata reported grant revenue of $1.0 million for the second quarter of 2023, attributed to its AP-SA02 program. The company's research and development expenses were approximately $8.3 million, reflecting ongoing investments in clinical trials and personnel. As of June 30, 2023, Armata held $12.5 million in unrestricted cash and cash equivalents, with a subsequent $25 million credit agreement with Innoviva bolstering its financial position.
Recent updates include the initiation of the Phase 2a portion of the diSArm study for AP-SA02 and the positive topline data from the SWARM-P.a. clinical trial. Armata is poised for significant advancements, supported by its strategic partnerships and robust development pipeline.
Armata Pharmaceuticals (NYSE: ARMP) announced positive topline results from its Phase 2 Tailwind trial of AP-PA02, an inhaled multi-phage therapeutic for treating chronic pulmonary Pseudomonas aeruginosa infections in non-cystic fibrosis bronchiectasis patients.
The trial demonstrated statistically significant reduction of P. aeruginosa in lung sputum, with effects persisting two weeks after treatment completion. A post-hoc analysis showed significant bacterial reduction at day 17 (P=0.05) and day 24 (P=0.015) compared to placebo. Approximately one-third of subjects treated with phage monotherapy showed at least a 2-log CFU reduction.
The treatment was well-tolerated with mostly mild adverse events, though one possibly related serious adverse event requiring hospitalization was reported. The study suggests AP-PA02 alone could be as effective as combination therapy with antibiotics.
Armata Pharmaceuticals (NYSE American: ARMP), a clinical-stage biotechnology company specializing in bacteriophage therapeutics for antibiotic-resistant bacterial infections, announced that CEO Dr. Deborah Birx will present at the 5th Annual Phage Futures Annual Meeting in Boston, MA. The presentation is scheduled for 1:15pm ET on November 19th, 2024.
Armata Pharmaceuticals announced Q3 2024 results and key developments. The company completed enrollment in two significant clinical trials: the Phase 2 'Tailwind' study of inhaled AP-PA02 for non-cystic fibrosis bronchiectasis, with topline data expected by year-end, and the Phase 1b/2a 'diSArm' study of intravenous AP-SA02 for S. aureus bacteremia, with results expected in Q1 2025. Financial highlights include grant revenue of $3.0M, R&D expenses of $9.5M, and a net loss of $5.5M ($0.15 per share). The company held $17.1M in cash as of September 30, 2024.
Armata Pharmaceuticals (NYSE American: ARMP) has completed enrollment (n=50) for its Phase 1b/2a diSArm study of intravenous AP-SA02, targeting Staphylococcus aureus bacteremia. The study aims to assess the safety, tolerability, and efficacy of AP-SA02, a bacteriophage therapy, as an adjunct to standard antibiotics. Armata expects topline data in Q1 2025, which could support the initiation of a pivotal efficacy trial later that year. Initial findings show no significant adverse events and evidence of in vivo phage amplification in half of the treated subjects. The study is backed by $21.6 million from the Defense Health Agency and the Joint Warfighter Medical Research Program.
Armata Pharmaceuticals (NYSE American: ARMP) announced a publication in Communications Biology describing the structure of phage Pa193, a key component of their multi-phage clinical candidate AP-PA02. The study, utilizing cryogenic electron microscopy, focuses on treating Pseudomonas aeruginosa infections in patients with cystic fibrosis (CF) or non-cystic fibrosis bronchiectasis (NCFB). The research provides detailed structural analysis at single atom resolution, offering insights into phage stability and genome-delivery mechanisms. This understanding could potentially expand clinical applications to other pathogens beyond P. aeruginosa.
Armata Pharmaceuticals (NYSE American: ARMP), a biotechnology company specializing in bacteriophage therapeutics for antibiotic-resistant infections, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event is set to take place in New York from September 9-11, 2024.
Dr. Deborah Birx, Armata's Chief Executive Officer, will deliver a corporate presentation on Wednesday, September 11, from 8:00-8:30 AM ET. This presentation offers an opportunity for investors to gain insights into Armata's innovative approach to treating difficult-to-treat bacterial infections using high-purity, pathogen-specific bacteriophage therapeutics.
Armata Pharmaceuticals (NYSE American: ARMP) announced a poster presentation at the 2024 Military Health System Research Symposium. The presentation highlights two phage development programs: inhaled AP-PA02 for Pseudomonas aeruginosa bronchiectasis and intravenous AP-SA02 for Staphylococcus aureus bacteremia. The company is 80% through enrollment in its Phase 1b/2a study (diSArm) of AP-SA02, expecting completion by end of 2024. AP-SA02 development is supported by a $21.6 million Department of Defense grant. Both phage candidates have been well-tolerated in clinical trials, allowing for higher doses. Armata plans to advance both candidates to pivotal Phase 3 trials in 2025. Preliminary data suggests intravenous AP-SA02 is active in all subjects, with longer persistence in some, potentially indicating in vivo amplification. Inhaled AP-PA02 shows promise as an alternative to inhaled antibiotics for P. aeruginosa bronchiectasis.
Armata Pharmaceuticals (NYSE American: ARMP) has appointed David House as Senior Vice President, Finance, effective August 16th. House brings extensive experience in senior accounting and finance roles within life sciences companies. CEO Dr. Deborah Birx highlighted House's expertise as valuable for advancing Armata's programs, AP-PA02 and AP-SA02, and preparing for pivotal studies next year.
House's previous roles include Corporate Controller at ZO Skin Health, where he managed global accounting operations and financial reporting. He also held key positions at Peregrine Pharmaceuticals and Avid Bioservices, implementing ASC 606 and managing SEC reporting. House's career spans various accounting and financial management positions in healthcare and technology sectors. He holds a Bachelor's degree in Business Administration with an Accounting concentration and has previously held a California CPA license.
Armata Pharmaceuticals (NYSE American: ARMP) announced its Q2 2024 results and provided a corporate update. Key developments include:
1. Completed enrollment in Phase 2 Tailwind study of AP-PA02 for Non-Cystic Fibrosis Bronchiectasis, with topline data expected in H2 2024.
2. Received $5.25 million in non-dilutive funding from the U.S. Department of Defense for the Phase 2a diSArm study of AP-SA02 for S. aureus bacteremia.
3. Completed build-out of advanced biologics manufacturing facility with five cGMP clean rooms.
Financial highlights: No grant revenue in Q2 2024 vs $1.0 million in Q2 2023. R&D expenses increased to $8.5 million. Loss from operations was $11.9 million. Cash and equivalents stood at $26.4 million as of June 30, 2024.
Armata Pharmaceuticals (NYSE American: ARMP) has received an additional $5.25 million in non-dilutive funding from the U.S. Department of Defense to support its ongoing diSArm clinical trial of AP-SA02. This Phase 1b/2a trial is evaluating AP-SA02 as a potential treatment for complicated Staphylococcus aureus bacteremia, a serious bloodstream infection often resistant to antibiotics. The study is currently 68% enrolled, aiming for approximately 50 subjects. It's designed as a randomized, double-blind, placebo-controlled trial to assess the safety, tolerability, and efficacy of intravenous AP-SA02 as an adjunct to best available antibiotic therapy.
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