ARMP Shareholder/Stockholder Letter Transcript:
Dear Fellow Shareholders,
Thank you for the opportunity to share Armata Pharmaceutical, Inc. s ( Armata or the
Company ) progress since last year s Annual Shareholder Meeting. Since that time, we have been
acutely focused on the critical development of our two clinical-stage phage product candidates,
which we believe have the potential to help address the growing global health crisis of bacterial
antimicrobial resistance.
Our first candidate is a multi-phage cocktail (AP-PA02) that we are developing as an inhaled
treatment for chronic pulmonary Pseudomonas aeruginosa infection in people with cystic fibrosis
and non-cystic fibrosis bronchiectasis ( NCFB ). Our second candidate, also a multi-phage
cocktail (AP-SA02), is being developed to treat Staphylococcus aureus bacteremia, an acute
clinical indication for which antibiotic resistance continues to be a growing problem. We believe
this dual approach of treating both chronic and acute infections allows us to address the broadest
range of unmet patient needs while also generating sustained long-term value for the Company.
The positive results of studies that we have completed to date support the initiation of pivotal
trials the next critical step for Armata as we work to advance the clinical development of these
novel pathogen-specific therapeutics towards registration and commercialization.
We have achieved significant progress towards these goals across three crucial areas:
1. With the completion of our new research and development and manufacturing facility in Los
Angeles, we now expect to be able to fully commercialize in the United States by utilizing our
state-of-the-art capabilities in developing and manufacturing phage therapeutics, including our
proprietary processes, validated release assays, high-throughput semi-automated fill and finish,
storage and shipment of drug product. All of our active pharmaceutical ingredients are sourced
in the United States with no offsite manufacturing. In parallel, we have significantly improved
the efficiency of all aspects of our production, increasing phage titers while maintaining high
purity of drug product. Additionally, we have increased shelf life at 4 C.
2. We accelerated patient enrollment in our two parallel Phase 2 clinical trials. Our NCFB
Pseudomonas trial ( Tailwind ) completed enrollment in the second half of 2024, which was
ahead of plan, and we released promising topline results in December of 2024. Tailwind was
the second patient population for AP-PA02, which was first evaluated in patients with cystic
fibrosis in the Phase 1b/2a SWARM-P.a. trial that successfully concluded in 2023.
We also accelerated enrollment in our Staphylococcus bacteremia trial ( DiSArm ),
announcing full enrollment in November 2024, with the last patient visit having taken place in
January 2025. During the execution of the trial, we were able to dose escalate to 5e10 PFU
every six hours (2E11 PFU every 24 hours) for five days without clinically significant adverse
events. In parallel with dose escalation, the evolution of two distinct blinded subsets of subjects
receiving phage has been observed. One subset, comprising approximately half of the treated
group, has evidence of persistence of detectable phage in the blood consistent with in vivo
phage amplification. This suggests that, despite the best available antibiotic treatment for
greater than five days, reservoirs of active Staphylococcus aureus bacteria remained that our
phages targeted, infected and killed before recirculating in the intravascular space. As of now,
we anticipate database lock and receipt of topline data in the next few weeks, where we can
explore the two aforementioned subsets in an unblinded manner. Topline results are also
expected to inform the optimal dose of AP-SA02 to be evaluated in the larger definitive
efficacy study.
3. Our research and development team has completed the engineering of both the Pseudomonas
and Staphylococcus production hosts, resulting in higher titers and maintaining high purity. We
believe this positions us well for the execution of future pivotal trials. We believe our advanced
process development capabilities ensure that we are a leader in the field in phage purity,
allowing us to dose escalate in both inhaled and intravenous routes of administration.
Finally, we are happy to report that we completed all prespecified actions outlined in last year s
proxy letter on time or ahead of plan.
In parallel, our leadership team is focused on managing costs and ensuring that our resources are
focused on efficient clinical trial execution backed by rigorous core science.
I am personally proud to be part of the highly committed team at Armata. Our continued strong
progress is the result of the passion and dedication of each employee to achieve our mission of
meeting the global challenge of antibiotic resistance by developing high-impact, best-in-class
phage therapeutics for all patients in need. Despite these uncertain times, we remain laser focused
on demonstrating the important role that phages can have in combatting serious bacterial infections
in the blood stream and lungs.
I speak for the entire Armata team when I say that I am optimistic about what the future holds for
the Company. I would like to thank you, our shareholders, for continuing to support our efforts
and sharing in our lofty goals.
Sincerely,
Deborah Birx, M.D.
Chief Executive Officer
4/28/2025 Letter Continued (Full PDF)