Armata Pharmaceuticals Receives $5.25 Million of Additional Non-Dilutive Grant Funding from the U.S. Department of Defense to Support Ongoing diSArm Clinical Trial of AP-SA02
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.
Armata Pharmaceuticals (NYSE American: ARMP) ha ricevuto un ulteriore 5,25 milioni di dollari in finanziamenti non diluitivi dal Dipartimento della Difesa degli Stati Uniti per sostenere il suo incontro clinico di diSArm relativo ad AP-SA02. Questo studio di fase 1b/2a sta valutando AP-SA02 come un possibile trattamento per la batteriemia da Staphylococcus aureus complicata, un'infezione grave del sangue spesso resistente agli antibiotici. Lo studio è attualmente 68% arruolato, con l'obiettivo di coinvolgere circa 50 soggetti. È progettato come uno studio randomizzato, in doppio cieco e controllato con placebo per valutare la sicurezza, la tollerabilità e l'efficacia di AP-SA02 per via endovenosa come complemento alla migliore terapia antibiotica disponibile.
Armata Pharmaceuticals (NYSE American: ARMP) ha recibido 5,25 millones de dólares en financiamiento no dilutivo del Departamento de Defensa de los Estados Unidos para apoyar su ensayo clínico diSArm de AP-SA02. Este ensayo de fase 1b/2a está evaluando AP-SA02 como un tratamiento potencial para la bacteriemia por Staphylococcus aureus complicada, una grave infección en el torrente sanguíneo que a menudo es resistente a los antibióticos. Actualmente, el estudio está 68% inscrito, con el objetivo de alrededor de 50 sujetos. Está diseñado como un ensayo aleatorizado, doble ciego y controlado con placebo para evaluar la seguridad, la tolerabilidad y la eficacia de AP-SA02 intravenoso como complemento de la mejor terapia antibiótica disponible.
Armata Pharmaceuticals (NYSE American: ARMP)는 AP-SA02의 diSArm 임상 시험을 지원하기 위해 미국 국방부로부터 5.25백만 달러의 비희석 자금을 추가로 받았습니다. 이 1b/2a 단계의 시험은 복잡한 황색포도상구균 혈증의 잠재적 치료제로 AP-SA02를 평가하고 있으며, 이는 종종 항생제에 저항성인 심각한 혈류 감염입니다. 현재 연구는 68% 등록 완료되었으며, 약 50명의 피험자를 목표로 하고 있습니다. 이 연구는 안전성, 내약성 및 정맥 주사 AP-SA02의 효능을 최상의 항생제 치료와 함께 평가하기 위한 무작위 이중 맹검 위약 대조 시험으로 설계되었습니다.
Armata Pharmaceuticals (NYSE American: ARMP) a reçu un financement supplémentaire de 5,25 millions de dollars en fonds non dilutifs du ministère de la Défense des États-Unis pour soutenir son essai clinique diSArm d'AP-SA02. Cet essai de phase 1b/2a évalue AP-SA02 comme un traitement potentiel pour la bactériémie compliquée par Staphylococcus aureus, une infection grave du sang souvent résistante aux antibiotiques. L'étude est actuellement 68% inscrite, avec un objectif d'environ 50 sujets. Elle est conçue comme un essai randomisé, en double aveugle et contrôlé par placebo pour évaluer la sécurité, la tolérabilité et l'efficacité d'AP-SA02 administré par voie intraveineuse en complément de la meilleure thérapie antibiotique disponible.
Armata Pharmaceuticals (NYSE American: ARMP) hat von dem US-Verteidigungsministerium zusätzliche 5,25 Millionen Dollar an nicht verwässernder Finanzierung erhalten, um die laufende diSArm-Studie zu AP-SA02 zu unterstützen. Diese phase 1b/2a Studie bewertet AP-SA02 als potenzielle Behandlung für komplizierte Staphylococcus aureus-Bakteriämie, eine schwere Blutbahninfection, die häufig gegen Antibiotika resistent ist. Die Studie ist derzeit zu 68% eingeschrieben und verfolgt das Ziel, etwa 50 Probanden zu haben. Sie ist als randomisierte, doppelblinde, placebo-kontrollierte Studie konzipiert, um die Sicherheit, Verträglichkeit und Wirksamkeit von intravenösem AP-SA02 in Ergänzung zur besten verfügbaren Antibiotikatherapie zu bewerten.
- Received $5.25 million in non-dilutive funding from the U.S. Department of Defense
- Clinical trial for AP-SA02 is 68% enrolled
- Addressing a serious medical need for antibiotic-resistant infections
- None.
Insights
The $5.25 million non-dilutive grant from the U.S. Department of Defense to Armata Pharmaceuticals is a significant boost for their ongoing diSArm clinical trial of AP-SA02. This funding underscores the potential importance of phage therapy in combating antibiotic-resistant infections, particularly Staphylococcus aureus bacteremia.
The Phase 1b/2a trial's focus on complicated S. aureus bacteremia is crucial, given the high morbidity and mortality rates associated with this condition. The study's design, incorporating a randomized, double-blind, placebo-controlled approach, adds robustness to the potential findings. With 68% enrollment already achieved, the trial is making steady progress.
However, investors should note that while promising, phage therapy is still an emerging field. The success of AP-SA02 is not guaranteed and the path to regulatory approval may be complex. The
The non-dilutive nature of this funding is particularly advantageous for shareholders, as it doesn't reduce their ownership stake while advancing the company's research. This could potentially lead to increased investor confidence and possibly a positive impact on stock valuation.
The additional
- It strengthens the company's cash position without diluting existing shareholders.
- It reduces the need for immediate equity or debt financing, potentially preserving favorable terms for future capital raises.
- It demonstrates confidence from a major institution (DoD) in Armata's technology and approach.
However, investors should consider that while beneficial, this grant alone is unlikely to fully fund the development of AP-SA02 through to commercialization. Armata may still need to secure additional funding in the future, which could impact stock valuation.
The company's focus on antibiotic-resistant infections represents a significant market opportunity, given the growing global concern over such threats. If successful, AP-SA02 could capture a portion of the multibillion-dollar antibiotics market.
Financially prudent investors should monitor Armata's burn rate, cash runway and any potential milestones that could trigger additional non-dilutive funding or partnership opportunities. The progress of the diSArm trial, currently at
Phase 1b/2a diSArm trial evaluating AP-SA02 as a potential treatment for complicated Staphylococcus aureus bacteremia
"S. aureus bacteremia is a serious bloodstream infection that is associated with high rates of morbidity and mortality and it is often resistant to most currently available antibiotics, creating an imminent need for more effective treatment alternatives," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "With this non-dilutive funding support from the DoD, we believe we are well positioned to efficiently advance AP-SA02 through clinical development and introduce this novel phage-based anti-infective to the benefit of military personnel and civilians alike."
The diSArm study is a Phase 1b/2a, randomized, double-blind, placebo-controlled, multiple ascending dose escalation study of the safety, tolerability, and efficacy of intravenous AP-SA02 as an adjunct to best available antibiotic therapy compared to best available antibiotic therapy alone for the treatment of adults with bacteremia due to Staphylococcus aureus.
This study is being conducted in two phases: Phase 1b evaluated the safety and tolerability of multiple ascending intravenous doses of AP-SA02 or placebo as an adjunct to best available therapy (BAT) compared to BAT alone in subjects with SA bacteremia (SAB). Phase 2a is evaluating the efficacy, safety, and tolerability of multiple doses of AP-SA02 or placebo as an adjunct to BAT compared to BAT alone in subjects with complicated SAB. The study is expected to enroll approximately 50 subjects. The study is currently
For more information on the diSArm study, see NCT05184764.
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.
ir@armatapharma.com
310-665-2928 x234
Investor Relations:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com
212-915-2569
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SOURCE Armata Pharmaceuticals, Inc.
FAQ
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