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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.
A joint venture involving HATCHspaces, NexCore Group, and Nuveen Real Estate has acquired a 56,300 sq ft industrial facility in Playa Vista, West Los Angeles. This site will be redeveloped into a cGMP biomanufacturing facility, serving as the headquarters for Armata Pharmaceuticals (NYSE: ARMP). The facility aims to produce treatments for antibiotic-resistant infections, addressing a critical need in the life sciences sector. This acquisition marks the fifth asset for the HATCH/NexCore venture, which now controls over 500,000 sq ft of life sciences space in the region.
Armata Pharmaceuticals (NYSE American: ARMP) announced FDA clearance for its Investigational New Drug application to initiate a Phase 2 clinical trial of AP-PA02 for non-cystic fibrosis bronchiectasis (NCFB). This condition, often linked to lung infections, currently has no approved treatments. The trial aims to assess the efficacy of AP-PA02 against Pseudomonas aeruginosa infections. Additionally, Armata is advancing other candidates for various bacterial infections, supported by recent financing.
Armata Pharmaceuticals (NYSE American: ARMP) announced its participation in two investor conferences in February and March 2022. The first event is BioCom California's 12th Annual Global Life Science Partnering Conference, taking place from February 22-24, where Pierre Kyme will present on February 23 at 3:30 PM PT. The second event is the 2nd Annual Chardan Microbiome Medicines Summit on March 1, featuring Brian Varnum at 10:00 AM ET. Armata specializes in bacteriophage therapeutics targeting antibiotic-resistant infections.
Innoviva reported substantial financial results for Q4 and full year 2021, with royalties rising by 18% to $111.1 million for Q4 and 19% to $405.7 million for the full year. Income from operations increased by 23% to $104.5 million in Q4 and 17% to $375.1 million for the year. Despite a $42.9 million decline in fair values of investments due to market volatility, the overall position remained strong with $201.5 million in cash and equivalents. A strategic investment of $45.0 million in Armata Pharmaceuticals is also highlighted.
Armata Pharmaceuticals announced a securities purchase agreement to sell common stock and warrants to Innoviva, raising $45 million before expenses. The funding will support Armata's clinical pipeline, particularly for AP-PA02 and AP-SA02, which target chronic Pseudomonas aeruginosa infections and complicated Staphylococcus aureus bacteremia, respectively. Innoviva will purchase 9 million shares at $5.00 each, with transactions occurring in two tranches. The second tranche is contingent on shareholder approval and is expected by the end of Q1 2022.
Armata Pharmaceuticals (NYSE American: ARMP) announced enhancements to its lead bacteriophage product candidate, AP-PA02, increasing its potency and coverage against Pseudomonas aeruginosa strains in cystic fibrosis and non-cystic fibrosis bronchiectasis patients. The new formulation introduces two additional phage genera, achieving over 90% coverage of tested isolates. Armata plans to enter a Phase 2 trial for non-cystic fibrosis bronchiectasis in 2022. The company is also developing a distinct phage cocktail for pneumonia. These advancements align with Armata's strategy to improve bacteriophage therapy effectiveness.
Armata Pharmaceuticals (NYSE American: ARMP) announced significant progress in its phage therapeutic development programs. The FDA has cleared its IND for the Phase 1b/2a trial of AP-SA02 targeting Staphylococcus aureus bacteremia, expected to start by year-end. Additionally, a $2 million milestone under the CF Foundation's Therapeutics Development Award has been achieved, raising the total to $3.75 million. The company is focused on combating drug-resistant bacterial infections with support from the Cystic Fibrosis Foundation and U.S. Department of Defense.
Armata Pharmaceuticals (ARMP) reported its third quarter 2021 results, revealing a loss from operations of $(6.1) million compared to $(5.6) million in Q3 2020. The company appointed Brian Varnum as CEO, succeeding Todd C. Patrick. Key developments included a $3.0 million equity investment from the Cystic Fibrosis Foundation and a $15 million award from the U.S. Department of Defense to support the AP-SA02 program. Research and development expenses rose to $5.6 million, indicating increased clinical trial activity. Armata's cash reserves grew to $12.1 million as of September 30, 2021.
Armata Pharmaceuticals announced that its Vice President of Clinical Development, Mina Pastagia, will present at the 2021 World Antimicrobial Resistance Congress in Washington D.C. on November 8. The presentation, titled A genomics-based approach for developing phage therapeutics targeting respiratory infections, will take place during the Innovation Showcase session at 2:30 pm ET.
This congress, now in its seventh year, will draw over 400 attendees and feature more than 150 speakers, focusing on antimicrobial resistance.
Armata Pharmaceuticals (NYSE American: ARMP) has announced a new lease for a 56,300 square-foot research and development and GMP manufacturing facility in Los Angeles. This state-of-the-art facility aims to enhance Armata's phage therapy pipeline and manufacturing capacity, supporting upcoming pivotal studies and commercial launches. The company is advancing its clinical candidates, AP-PA02 and AP-SA02, and believes the facility will facilitate potential strategic partnerships to bolster its pipeline and accelerate development.
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