Latest news with #ArmataPharmaceuticals
Associated Press
19-05-2025
- Health
- Associated Press
Armata Pharmaceuticals Announces Positive Topline Data from the Phase 1b/2a diSArm Study of Intravenously Administered AP-SA02 in Complicated Staphylococcus aureus Bacteremia
All primary endpoints for safety, tolerability, and clinical response in the intent-to-treat population met AP-SA02 arm significantly improved clinical outcomes and prevented relapse compared to best available antibiotic therapy No treatment-related serious adverse events were observed with repetitive intravenous dosing LOS ANGELES, May 19, 2025 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ('Armata' or the 'Company'), a clinical-stage biotechnology company focused on the development of high-purity, pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections, today announced positive topline results from its Phase 1b/2a diSArm trial which evaluated AP-SA02, a novel intravenous ('IV') administered multi-phage therapeutic for the treatment of Staphylococcus aureus ('S. aureus') bacteremia ('SAB'), in the intent-to-treat ('ITT') population. 'This trial and these data are what the field of phage therapy has been eagerly awaiting for over a decade and represent a critical leap forward for Armata and for the role of bacteriophages in combating life-threatening systemic infections,' stated Dr. Deborah Birx, Chief Executive Officer of Armata. The diSArm study ( NCT05184764 ) was a Phase 1b/2a, multicenter, randomized, double-blind, placebo-controlled, multiple ascending dose escalation study of the safety, tolerability, and efficacy of intravenous AP-SA02 in addition to best available antibiotic therapy ('BAT') compared to BAT alone (placebo) for the treatment of adults with complicated SAB. Safety and efficacy were assessed in the ITT population, which included all subjects (n=50) who received at least one dose of AP-SA02 or placebo. AP-SA02, administered IV every six hours for five days, was well-tolerated, with no serious adverse events related to the study drug. Two subjects had adverse events that were possibly related to the study drug: one with transient liver enzyme elevation and one with hypersensitivity that resolved with discontinuation of vancomycin. The primary clinical efficacy endpoint for the Phase 2a portion of the diSArm study was clinical outcome (responder rate) in subjects with complicated bacteremia, measured at (i) Test of Cure ('TOC') for AP-SA02, defined as one week following the end of IV treatment with AP-SA02 (day 12), (ii) TOC for BAT, defined as one week following the end of IV BAT, and (iii) end of study ('EOS'), defined as four weeks following the end of IV BAT. A statistically significant increase in investigator-assessed responder rate was observed at TOC for AP-SA02 (day 12) in AP-SA02 treated subjects (88%) versus placebo (58%) (p = 0.047). At TOC for BAT and at EOS, 100% of the AP-SA02 treated subjects had clinically responded (p = 0.017) versus 25% of placebo subjects considered non-responsive due to either relapse or treatment failure, consistent with the non-responder rate reported in the literature for recent phase 3 trials. Of note, the clinical response with AP-SA02 occurred regardless of whether subjects were infected with methicillin-sensitive S. aureus ('MSSA') or methicillin-resistant S. aureus ('MRSA'). All subjects infected with MRSA and treated with AP-SA02 and BAT cleared their infection by TOC for BAT with no evidence of relapse through EOS, as compared to the relapse rate of BAT alone as noted above. Supporting the investigator assessment, clinical outcome was assessed by the Clinical Efficacy Adjudication Committee, comprised of leading doctors in the bacteremia field, who agreed that subjects who received placebo had a 22% and 25% non-responder rate at TOC with BAT and at EOS, respectively, while 100% of the subjects who received AP-SA02 clinically responded (p = 0.025: TOC BAT; p = 0.020: EOS). Additionally, faster time to a negative blood culture and decline of key predictors of mortality and complications in SAB, including interleukin-10 and C-reactive protein, support the improved responder rates in subjects treated with AP-SA02. 'This clinical trial is groundbreaking in two fundamental ways: firstly, this is the first clear evidence in a randomized controlled trial of the efficacy of phage against a serious systemic pathogen that is responsible for significant morbidity and mortality in the United States, and secondly, Armata was able to successfully produce high titer phage with high purity allowing for repetitive IV administration every six hours without significant safety concerns,' continued Dr. Birx. 'We previously demonstrated the persistence of AP-SA02 in the IV space on multiple days one hour post IV push. Critically, these trial results support AP-SA02 homing to different sites of infection, presumably penetrating biofilms, and infecting and lysing the target S. aureus bacteria, independent of antibiotic resistance patterns and site of infection.' 'These data, including the favorable safety profile of AP-SA02, warrant that we move as rapidly as possible towards initiation of a pivotal trial. I am grateful to the patients who participated in this study, our excellent trial sites, and the unrelenting commitment of the Armata team. Finally, this progress and this initial breakthrough would not have been possible without ongoing support from Innoviva and the U.S. Department of Defense.' 'Importantly, Armata has developed the capacity to manufacture drug product at its cGMP facility in California. All Active Pharmaceutical Ingredients are maintained in house and Armata's current proprietary manufacturing process can produce over 10,000 full courses of phage therapy annually, distributed from its facility, consistent with supporting the need to onshore biomedical breakthroughs needed by the American people,' Dr. Birx concluded. Armata's latest corporate presentation with topline results from the Phase 1b/2a diSArm study can be found here. About Armata Pharmaceuticals, Inc. Armata is a clinical-stage biotechnology company focused on the development of high-purity 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 current Good Manufacturing Practices ('cGMP') manufacturing to support full commercialization. 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 cGMP; 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 U.S. Securities and Exchange Commission (the 'SEC'), including in Armata's Annual Report on Form 10-K, filed with the SEC on March 21, 2025, 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 View original content to download multimedia: SOURCE Armata Pharmaceuticals, Inc.
Yahoo
14-05-2025
- Business
- Yahoo
Armata Pharmaceuticals, Inc. (ARMP) Reports Q1 Loss, Lags Revenue Estimates
Armata Pharmaceuticals, Inc. (ARMP) came out with a quarterly loss of $0.20 per share versus the Zacks Consensus Estimate of a loss of $0.38. This compares to loss of $0.69 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 47.37%. A quarter ago, it was expected that this company would post a loss of $0.35 per share when it actually produced a loss of $0.23, delivering a surprise of 34.29%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Armata Pharmaceuticals , which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $0.49 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 64.42%. This compares to year-ago revenues of $0.97 million. The company has topped consensus revenue estimates just once over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Armata Pharmaceuticals shares have lost about 23.2% since the beginning of the year versus the S&P 500's gain of 0.1%. While Armata Pharmaceuticals has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Armata Pharmaceuticals: unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #5 (Strong Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.39 on $1.38 million in revenues for the coming quarter and -$1.94 on $5.5 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 30% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the same industry, Precision BioSciences (DTIL), has yet to report results for the quarter ended March 2025. The results are expected to be released on May 15. This genome editing company is expected to post quarterly loss of $0.43 per share in its upcoming report, which represents a year-over-year change of -22.9%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Precision BioSciences' revenues are expected to be $10 million, down 43.1% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Armata Pharmaceuticals, Inc. (ARMP) : Free Stock Analysis Report Precision BioSciences, Inc. (DTIL) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
20-03-2025
- Business
- Yahoo
Armata Pharmaceuticals Announces Fourth Quarter and Full-Year 2024 Results and Provides Corporate Update
LOS ANGELES, March 20, 2025 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a clinical-stage biotechnology company focused on the development of high-purity, pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections, today announced financial results for its fourth quarter and full-year ended December 31, 2024, and provided a corporate update. Fourth Quarter 2024 and Recent Developments: Announced encouraging topline results from its Phase 2 Tailwind study evaluating inhaled AP-PA02 as a potential treatment for chronic pulmonary disease; Pseudomonas aeruginosa ("P. aeruginosa" or "P.a.") infection in non-cystic fibrosis bronchiectasis ("NCFB") patients. The Phase 2 Tailwind study represents the second successful clinical trial for AP-PA02, Armata's lead pulmonary candidate, which was first evaluated in people with cystic fibrosis in the Phase 1b/2a SWARM-P.a. trial that completed in 2023; Inhaled AP-PA02 was well-tolerated, with treatment-emergent adverse events mild and self-limiting; Post-hoc intent-to-treat analysis demonstrated a statistically significant reduction of P.a. colony forming units ("CFUs") at one and two weeks post-dosing. Approximately one-third of all subjects treated with phage monotherapy exhibited at least a 2-log CFU reduction in P.a.; and Data suggest AP-PA02 alone is as effective as AP-PA02 plus antibiotics in reducing P.a. CFUs in the lungs of NCFB patients, and indicates the potential for phage therapy to reduce reliance on chronic antibiotic use. Completed enrollment of Phase 1b/2a diSArm study of intravenous ("IV") AP-SA02 as a potential treatment for Staphylococcus aureus ("S. aureus") bacteremia. Blinded data demonstrates AP-SA02 is well-tolerated following IV administration of up to 5E10 plaque forming units ("PFUs") every six hours (2E11 PFU every 24 hours) for five days; Persistence of AP-SA02 in a subset of complicated bacteremia subjects is consistent with in vivo phage amplification despite 48-72 hours of broad-spectrum IV antibiotics -- unblinding is critical to understand subjects' clinical presentation; Topline data anticipated in the first half of 2025; and Anticipate that findings from the diSArm study will inform the design of a pivotal trial strategy to be discussed with the U.S. Food and Drug Administration (the "FDA") that may enable Armata to obtain agreement on a path to potential approval. Further advanced bacteriophage science through presentations and publications. Presented at 7th Annual Phage Therapy Summit, March 11-13, 2025, Boston, MA; Presented at 5th Annual Phage Futures Meeting, November 19, 2024, Boston, MA; and Announced structural biology publication in the journal Communications Biology describing a representative phage in Armata's clinical candidate, AP-PA02. In March 2025, entered into a $10.0 million secured credit agreement with Innoviva Strategic Opportunities LLC, a wholly-owned subsidiary of Innoviva, Armata's principal shareholder. "During the fourth quarter, we achieved another significant clinical milestone with encouraging topline results from our Phase 2 Tailwind study evaluating inhaled AP-PA02 in NCFB patients as both monotherapy and in combination with inhaled anti-pseudomonal antibiotics," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "This was the second successful clinical evaluation of AP-PA02 following our Phase 1b/2a SWARM-P.a. trial in cystic fibrosis patients. We believe the learnings gained from the two completed Phase 2 studies position Armata to design a pivotal trial to evaluate AP-PA02 as an alternative to antibiotics in NCFB patients with chronic pulmonary P. aeruginosa infection." "We also completed enrollment of our Phase 1b/2a diSArm study evaluating our high purity phage product candidate, AP-SA02, as a potential treatment for S. aureus bacteremia. We expect to report topline results in the first half of this year, and believe data will provide valuable insights into the safety and tolerability of AP-SA02 at high intravenous doses, and inform the dose and schedule to be studied in a larger efficacy study, which we plan to discuss with the FDA this year." "We remain committed to developing a definitive efficacy trial focused on phage as an alternative to broad-spectrum antibiotics and/or antibiotic-sparing to decrease the utilization of traditional antibiotics and their detrimental impact on the normal human microbiome. I believe we are well positioned to achieve value-creating milestones in 2025 as the Armata team continues to work to introduce a novel therapeutic class to help fight the global health crisis of antimicrobial resistance," Dr. Birx concluded. Fourth Quarter 2024 Financial Results Grant Revenue. The Company recognized grant revenue of $1.2 million for the three months ended December 31, 2024 as compared to $1.5 million in the comparable period in 2023, which represents MTEC's share of the costs incurred for the Company's AP-SA02 program for the treatment of S. aureus bacteremia. Research and Development. Research and development expenses for the three months ended December 31, 2024 were approximately $8.5 million as compared to approximately $7.9 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 December 31, 2024 were approximately $3.3 million as compared to approximately $3.2 million for the comparable period in 2023. The increase was mainly related to an increase of $0.3 million in personnel related expenses during the fourth quarter of 2024, offset in part by a decrease of $0.2 million in professional services. Loss from Operations. Loss from operations for the three months ended December 31, 2024 was approximately $10.5 million as compared to a loss from operations of approximately $9.6 million for the comparable period in 2023. Net Income (Loss). The net income for the fourth quarter of 2024 was $2.6 million, or $0.07 per share on a basic and $(0.23) per share on a diluted basis, as compared to a net loss of $19.8 million, or $(0.55) per share on both a basic and diluted basis, for the comparable period in 2023. The net income for the quarter ended December 31, 2024 included non-cash gain from the changes in fair value of convertible loan of $14.2 million and non-cash gain from debt extinguishment of $2.2 million, as compared to $8.9 million loss from the changes in fair value of convertible loan for the quarter ended December 31, 2023. Cash and Equivalents. As of December 31, 2024, Armata held approximately $14.8 million of cash and cash equivalents and restricted cash, as compared to $19.2 million as of December 31, 2023. On March 12, 2025, the Company entered into a credit and security agreement for a loan in an aggregate amount of $10.0 million with Innoviva SO. The loan bears interest at an annual rate of 14% and matures on March 12, 2026. Principal and accrued interest are payable at maturity. The Company and Innoviva also entered into amendments to the three pre-existing credit and security agreements in order to, among other things, extend the maturity dates under such agreements to March 12, 2026. As of February 28, 2025, 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 high-purity 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 to support full commercialization. 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 20, 2025, 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 Kymeir@ Investor Relations:Joyce AllaireLifeSci Advisors, LLCjallaire@ Armata Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets (in thousands) December 31, 2024December 31, 2023AssetsCurrent assetsCash and cash equivalents$ 9,291$ 13,523Prepaid expenses and other current assets 1,273 2,265Other receivables 744 3,363Total current assets 11,308 19,151Property and equipment, net 13,241 12,559Operating lease right-of-use asset 41,687 44,717Intangible assets, net 13,746 13,746Other long term assets 6,455 8,190Total assets$ 86,437$ 98,363Liabilities and stockholders' deficitAccounts payable, accrued and other current liabilities 9,295 16,461Term debt, current 38,954 —Total current liabilities$ 48,249$ 16,461Convertible loan, non-current 32,897 58,633Term debt, non-current 22,539 23,674Operating lease liabilities, net of current portion 27,694 28,583Deferred tax liability 3,077 3,077Total liabilities 134,456 130,428Stockholders' deficit (48,019) (32,065)Total liabilities and stockholders' deficit$ 86,437$ 98,363 Armata Pharmaceuticals, Inc. Condensed Consolidated Statements of Operations (in thousands, except share and per share data)Three Months Ended Year Ended December 31, December 31, 2024202320242023Grant revenue$ 1,235$ 1,528$ 5,174$ 4,529Operating expensesResearch and development 8,450 7,928 34,426 33,770General and administrative 3,323 3,179 13,184 11,649Total operating expenses 11,773 11,107 47,610 45,419Operating loss (10,538) (9,579) (42,436) (40,890)Interest income 130 68 697 179Interest expense (3,281) (1,450) (10,742) (2,626)Change in fair value of convertible loan 14,123 (8,886) 31,399 (21,845)Gain (loss) on debt and convertible loan extinguishments 2,166 — 2,166 (3,863)Net income (loss)$ 2,600$ (19,847)$ (18,916)$ (69,045)Per share information: Net income (loss) per share, basic$ 0.07$ (0.55)$ (0.52)$ (1.91) Weighted average shares outstanding, basic 36,183,067 36,100,869 36,160,848 36,075,555 Net loss per share, diluted$ (0.23)$ (0.55)$ (0.89)$ (1.91) Weighted average shares outstanding, diluted 59,082,190 36,100,869 59,059,971 36,075,555 Armata Pharmaceuticals, Inc. Condensed Consolidated Statements of Cash Flows (in thousands) Year Ended December 31, 20242023Operating activities:Net loss$ (18,916)$ (69,045)Adjustments required to reconcile net loss to net cash used in operating activities:Depreciation and amortization expense 1,325 972Stock-based compensation expense 2,893 938Change in fair value of convertible loan (31,399) 21,845Non-cash interest expense 10,758 2,573Non-cash interest income — (22)Gain (loss) on debt and convertible loan extinguishments (2,166) 3,863Change in right-of-use asset 2,053 1,018Loss from disposal of property and equipment — 81Changes in operating assets and liabilities: (2,099) (9,646)Net cash used in operating activities (37,551) (47,423)Investing activities:Purchases of property and equipment (1,879) (8,144)Proceeds from sale of property and equipment — 10Net cash used in investing activities (1,879) (8,134)Financing activities:Proceeds from issuance of convertible loan, net of issuance costs — 29,101Proceeds from issuance of term debt, net of issuance costs 34,889 24,925Payments for taxes related to net share settlement of equity awards (61) (43)Proceeds from exercise of stock options 130 5Net cash provided by financing activities 34,958 53,988Net decrease in cash, cash equivalents and restricted cash (4,472) (1,569)Cash, cash equivalents and restricted cash, beginning of period 19,243 20,812Cash, cash equivalents and restricted cash, end of period$ 14,771$ 19,243 Year Ended December 31, 20242023 Cash and cash equivalents$ 9,291$ 13,523 Restricted cash 5,480 5,720 Cash, cash equivalents and restricted cash, end of period$ 14,771$ 19,243 View original content to download multimedia: SOURCE Armata Pharmaceuticals, Inc.
Yahoo
11-03-2025
- Business
- Yahoo
Armata Pharmaceuticals Announces that CEO Dr. Deborah Birx Will Deliver a Presentation at the 7th Annual Bacteriophage Therapy Summit
LOS ANGELES, March 11, 2025 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a clinical-stage biotechnology company focused on the development of high-purity pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections, today announced that Dr. Deborah Birx, Chief Executive Officer, will deliver a presentation at 9:00am ET on Thursday, March 13, 2025 at the 7th Annual Bacteriophage Therapy Summit, being held in Boston, MA. For more information: 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 to support full commercialization. Media Contacts: At Armata:Pierre KymeArmata Pharmaceuticals, x234 Investor Relations:Joyce AllaireLifeSci Advisors, LLCjallaire@ View original content to download multimedia: SOURCE Armata Pharmaceuticals, Inc. Sign in to access your portfolio
Globe and Mail
11-03-2025
- Business
- Globe and Mail
Non-Cystic Fibrosis Bronchiectasis Clinical Trials and Pipeline 2025: EMA, PDMA, FDA Approvals, Medication, NDA Approval, Therapies, ROA, MOA and Companies by DelveInsight
"Non-Cystic Fibrosis Bronchiectasis Pipeline" Non-Cystic Fibrosis Bronchiectasis companies in the treatment market are NovaBiotics Ltd, Synspira Therapeutics, Parion Sciences, Chiesi Farmaceutic, CSL Behring, Haisco Pharmaceutical, SolAeroMed Inc., AstraZeneca, Zambon SpA, Boehringer Ingelheim, Armata Pharmaceuticals, Renovion, and others. (Albany, USA) 'Non-Cystic Fibrosis Bronchiectasis Pipeline Insight, 2025' report by DelveInsight outlines comprehensive insights into the present clinical development scenario and growth prospects across the Non-Cystic Fibrosis Bronchiectasis Market. The Non-Cystic Fibrosis Bronchiectasis Pipeline report embraces in-depth commercial and clinical assessment of the pipeline products from the pre-clinical developmental phase to the marketed phase. The report also covers a detailed description of the drug, including the mechanism of action of the drug, clinical studies, NDA approvals (if any), and product development activities comprising the technology, collaborations, mergers acquisition, funding, designations, and other product-related details. As per DelveInsight's assessment, globally, Non-Cystic Fibrosis Bronchiectasis pipeline constitutes 16+ key companies continuously working towards developing 17+ Non-Cystic Fibrosis Bronchiectasis treatment therapies, analysis of Clinical Trials, Therapies, Mechanism of Action, Route of Administration, and Developments analyzes DelveInsight. Some of the key takeaways from the Non-Cystic Fibrosis Bronchiectasis Pipeline Report: NCFB Companies across the globe are diligently working toward developing novel Non-Cystic Fibrosis Bronchiectasis treatment therapies with a considerable amount of success over the years. Non-Cystic Fibrosis Bronchiectasis companies working in the treatment market are NovaBiotics Ltd, Synspira Therapeutics, Parion Sciences, Chiesi Farmaceutic, CSL Behring, Haisco Pharmaceutical, SolAeroMed Inc., AstraZeneca, Zambon SpA, Boehringer Ingelheim, Armata Pharmaceuticals, Renovion, and others, are developing therapies for the Non-Cystic Fibrosis Bronchiectasis treatment. Emerging Non-Cystic Fibrosis Bronchiectasis therapies in the different phases of clinical trials are- NP339, Research Programme:NCFB, Research programme: mucolytic agents, CHF 6333, CSL787, HSK31858, S-1226, Benralizumab, Colistimethate sodium, BI 1291583, AP-PA02, ARINA-1, and others are expected to have a significant impact on the Non-Cystic Fibrosis Bronchiectasis market in the coming years. In February 2025, Insmed Incorporated announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Brensocatib for patients with non-cystic fibrosis bronchiectasis. In October 2024, Insmed shared positive late-breaking subgroup data from the Phase III ASPEN study of brensocatib for patients with NCFB at the CHEST 2024 Annual Meeting. In July 2024, Armata Pharmaceuticals stated that it had completed enrollment in its Tailwind Phase 2 clinical trial of inhaled AP-PA02 in patients with NCFB and chronic pulmonary Pseudomonas aeruginosa (P. aeruginosa) infection. In May 2024, Insmed Incorporated reported encouraging topline results from the ASPEN study, a global, randomized, double-blind, placebo-controlled Phase 3 trial to evaluate brensocatib's effectiveness, safety, and tolerability in patients with non-cystic fibrosis bronchiectasis. The study accomplished its primary aim, with both brensocatib dose strengths showing statistically significant reductions in the annualized rate of pulmonary exacerbations (PEs) compared to placebo. The study also met several of its predetermined secondary goals with statistical significance. In July 2023, Zambon, a global pharmaceutical company dedicated to innovating treatments and enhancing the health and well-being of patients, revealed the conclusive findings from the Phase 3 PROMIS-I and PROMIS-II studies. These results were unveiled during the 2023 6th World Bronchiectasis Conference held in New York, NY. In December 2022, Haisco Pharmaceutical Group Co., Ltd. has commenced a trial titled 'Phase 2 Randomized, Double-blind, Placebo-controlled, Multicenter Study.' This study aims to evaluate the effectiveness and safety of HSK31858 in individuals diagnosed with Non-cystic Fibrosis Bronchiectasis. In April 2022, The FDA awarded breakthrough therapy designation to colistimethate sodium powder intended for nebulization solution to alleviate pulmonary exacerbations in adults afflicted with Non-cystic fibrosis bronchiectasis and Pseudomonas aeruginosa. The basis for the FDA's breakthrough therapy designation was supported by findings from the phase III PROMIS-I study, showcasing that CMS I-neb notably decreased annual rates of pulmonary exacerbations compared to a placebo within this patient population. Non-Cystic Fibrosis Bronchiectasis Overview Non-Cystic Fibrosis Bronchiectasis (NCFBE) is a chronic lung condition characterized by permanent dilation and damage of the bronchi, leading to impaired mucus clearance and recurrent infections. Unlike cystic fibrosis-related bronchiectasis, NCFBE is caused by underlying conditions such as chronic infections, autoimmune diseases, primary ciliary dyskinesia, allergic bronchopulmonary aspergillosis (ABPA), or immune deficiencies. Patients with NCFBE experience persistent cough, excessive mucus production, recurrent respiratory infections, and shortness of breath, fatigue, and wheezing. The accumulation of mucus creates a breeding ground for bacteria, leading to frequent exacerbations and lung function decline. Common pathogens, including Pseudomonas aeruginosa and Haemophilus influenzae, contribute to disease progression and complications. Non-Cystic Fibrosis Bronchiectasis Diagnosis involves high-resolution computed tomography (HRCT) scans, pulmonary function tests, sputum cultures, and blood tests to identify underlying causes. Non-Cystic Fibrosis Bronchiectasis Treatment focuses on airway clearance therapies, bronchodilators, inhaled antibiotics, corticosteroids, and mucolytics to reduce symptoms and prevent exacerbations. Pulmonary rehabilitation, vaccination, and lifestyle modifications also play a crucial role in disease management. While NCFBE is a chronic and progressive condition, advancements in targeted therapies, biologics, and precision medicine are improving patient outcomes, reducing exacerbations, and enhancing quality of life. Emerging Non-Cystic Fibrosis Bronchiectasis Drugs Under Different Phases of Clinical Development Include: Non-Cystic Fibrosis Bronchiectasis Route of Administration Non-Cystic Fibrosis Bronchiectasis pipeline report provides the therapeutic assessment of the pipeline drugs by the Route of Administration. Products have been categorized under various ROAs, such as Intravenous Subcutaneous Oral Intramuscular Non-Cystic Fibrosis Bronchiectasis Molecule Type Non-Cystic Fibrosis Bronchiectasis Products have been categorized under various Molecule types, such as Monoclonal antibody Small molecule Peptide Non-Cystic Fibrosis Bronchiectasis Pipeline Therapeutics Assessment Non-Cystic Fibrosis Bronchiectasis Assessment by Product Type Non-Cystic Fibrosis Bronchiectasis By Stage and Product Type Non-Cystic Fibrosis Bronchiectasis Assessment by Route of Administration Non-Cystic Fibrosis Bronchiectasis By Stage and Route of Administration Non-Cystic Fibrosis Bronchiectasis Assessment by Molecule Type Non-Cystic Fibrosis Bronchiectasis by Stage and Molecule Type DelveInsight's Non-Cystic Fibrosis Bronchiectasis Report covers around 17+ products under different phases of clinical development like Late-stage products (Phase III) Mid-stage products (Phase II) Early-stage product (Phase I) Pre-clinical and Discovery stage candidates Discontinued & Inactive candidates Route of Administration Further Non-Cystic Fibrosis Bronchiectasis product details are provided in the report. Download the Non-Cystic Fibrosis Bronchiectasis pipeline report to learn more about the emerging Non-Cystic Fibrosis Bronchiectasis therapies @ Non-Cystic Fibrosis Bronchiectasis Treatment Market Some of the key companies in the Non-Cystic Fibrosis Bronchiectasis Therapeutics Market include: Key companies developing therapies for Non-Cystic Fibrosis Bronchiectasis are – Insmed Incorporated, AstraZeneca, Zambon, CSL Behring, Chiesi Farmaceutici, Haisco Pharmaceutical, Boehringer Ingelheim, Armata Pharmaceuticals, Renovion, SolAeroMed, and others. Non-Cystic Fibrosis Bronchiectasis Pipeline Analysis: The Non-Cystic Fibrosis Bronchiectasis pipeline report provides insights into The report provides detailed insights about companies that are developing therapies for the treatment of Non-Cystic Fibrosis Bronchiectasis with aggregate therapies developed by each company for the same. It accesses the Different therapeutic candidates segmented into early-stage, mid-stage, and late-stage of development for Non-Cystic Fibrosis Bronchiectasis Treatment. Non-Cystic Fibrosis Bronchiectasis key companies are involved in targeted therapeutics development with respective active and inactive (dormant or discontinued) projects. Non-Cystic Fibrosis Bronchiectasis Drugs under development based on the stage of development, route of administration, target receptor, monotherapy or combination therapy, a different mechanism of action, and molecular type. Detailed analysis of collaborations (company-company collaborations and company-academia collaborations), licensing agreement and financing details for future advancement of the Non-Cystic Fibrosis Bronchiectasis market. The report is built using data and information traced from the researcher's proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations, and featured press releases from company/university websites and industry-specific third-party sources, etc. Download Sample PDF Report to know more about Non-Cystic Fibrosis Bronchiectasis drugs and therapies – Non-Cystic Fibrosis Bronchiectasis Clinical Trials and Advancements Non-Cystic Fibrosis Bronchiectasis Pipeline Market Drivers Recent Developments to Improve Research into Bronchiectasis, emergence of Novel Drugs & Therapies with Great Market Potential are some of the important factors that are fueling the Non-Cystic Fibrosis Bronchiectasis Market. Non-Cystic Fibrosis Bronchiectasis Pipeline Market Barriers However, challenges Associated with the Drug Delivery, regulatory & Economic Hindrance and other factors are creating obstacles in the Non-Cystic Fibrosis Bronchiectasis Market growth. Scope of Non-Cystic Fibrosis Bronchiectasis Pipeline Drug Insight Coverage: Global Key Non-Cystic Fibrosis Bronchiectasis Companies: NovaBiotics Ltd, Synspira Therapeutics, Parion Sciences, Chiesi Farmaceutic, CSL Behring, Haisco Pharmaceutical, SolAeroMed Inc., AstraZeneca, Zambon SpA, Boehringer Ingelheim, Armata Pharmaceuticals, Renovion, and others Key Non-Cystic Fibrosis Bronchiectasis Therapies: NP339, Research Programme:NCFB, Research programme: mucolytic agents, CHF 6333, CSL787, HSK31858, S-1226, Benralizumab, Colistimethate sodium, BI 1291583, AP-PA02, ARINA-1, and others Non-Cystic Fibrosis Bronchiectasis Therapeutic Assessment: Non-Cystic Fibrosis Bronchiectasis current marketed and Non-Cystic Fibrosis Bronchiectasis emerging therapies Non-Cystic Fibrosis Bronchiectasis Market Dynamics: Non-Cystic Fibrosis Bronchiectasis market drivers and Non-Cystic Fibrosis Bronchiectasis market barriers Table of Contents 1. Non-Cystic Fibrosis Bronchiectasis Report Introduction 2. Non-Cystic Fibrosis Bronchiectasis Executive Summary 3. Non-Cystic Fibrosis Bronchiectasis Overview 4. Non-Cystic Fibrosis Bronchiectasis- Analytical Perspective In-depth Commercial Assessment 5. Non-Cystic Fibrosis Bronchiectasis Pipeline Therapeutics 6. Non-Cystic Fibrosis Bronchiectasis Late Stage Products (Phase II/III) 7. Non-Cystic Fibrosis Bronchiectasis Mid Stage Products (Phase II) 8. Non-Cystic Fibrosis Bronchiectasis Early Stage Products (Phase I) 9. Non-Cystic Fibrosis Bronchiectasis Preclinical Stage Products 10. Non-Cystic Fibrosis Bronchiectasis Therapeutics Assessment 11. Non-Cystic Fibrosis Bronchiectasis Inactive Products 12. Company-University Collaborations (Licensing/Partnering) Analysis 13. Non-Cystic Fibrosis Bronchiectasis Key Companies 14. Non-Cystic Fibrosis Bronchiectasis Key Products 15. Non-Cystic Fibrosis Bronchiectasis Unmet Needs 16 . Non-Cystic Fibrosis Bronchiectasis Market Drivers and Barriers 17. Non-Cystic Fibrosis Bronchiectasis Future Perspectives and Conclusion 18. Non-Cystic Fibrosis Bronchiectasis Analyst Views 19. Appendix 20. About DelveInsight About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance. It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate business growth and overcome challenges with a practical approach. Media Contact Company Name: DelveInsight Business Research LLP Contact Person: Ankit Nigam Email: Send Email Phone: +14699457679 Address: 304 S. Jones Blvd #2432 City: Albany State: New York Country: United States Website:
