AP-PA02 / Armata - LARVOL DELTA

Armata Pharmaceuticals Announces $10 Million Secured Credit Agreement with Innoviva (PRNewswire) - "Armata Pharmaceuticals...announced that it has entered into a secured credit agreement with Innoviva Strategic Opportunities LLC, a wholly-owned subsidiary of Innoviva..., Armata's largest shareholder. The gross proceeds to be received by the Company at closing are $10 million before deducting transaction-related expenses. Proceeds from the new financing transaction will be used to advance the Company's lead therapeutic phage candidates, including AP-PA02 and AP-SA02, which target infections caused by Pseudomonas aeruginosa and Staphylococcus aureus, respectively....'This financing will enable Armata to readout its Phase 1b/2a trial in acute Staphylococcus aureus bacteremia, which represents the first clinical trial for AP-SA02, and to prepare the Company for an end-of-Phase 2 meeting with the FDA in support of further clinical inquiry including a potential pivotal trial'."

Financing • Infectious Disease

Armata Pharmaceuticals Announces Encouraging Results from the Phase 2 Tailwind Study of Inhaled AP-PA02 in Non-Cystic Fibrosis Bronchiectasis Subjects with Chronic Pulmonary Pseudomonas aeruginosa Infection (PRNewswire) - P2 | N=48 | Tailwind (NCT05616221) | Sponsor: Armata Pharmaceuticals, Inc. | "The primary efficacy endpoint was the reduction in P.a. colony forming units ('CFUs') in the lung sputum at one week following completion of dosing (day 17) compared to baseline. Per the statistical analysis plan, efficacy analysis of each independent cohort showed no significant difference between subjects treated with AP-PA02 and placebo due to small numbers of subjects in each cohort. Notably, a post-hoc intent-to-treat analysis...demonstrated a statistically significant reduction of P.a. CFUs in the lung at day 17 (AP-PA02 vs. placebo; P=0.05). The reduction in P.a. CFUs persisted two weeks following completion of dosing with AP-PA02 when compared with placebo at day 24...Additionally, paired analysis of P.a. CFU density at baseline compared to day 10 (P=0.03), day 11 (P=0.01), day 17 (P=0.003) and day 24 (P=0.018) was significant in the AP-PA02-treated cohort."

P2 data • Bronchiectasis • Non‐Cystic Fibrosis Bronchiectasis

Armata Pharmaceuticals Announces Third Quarter 2024 Results and Provides Corporate Update (PRNewswire) - "Completed enrollment of the Phase 2 study ('Tailwind') of inhaled AP-PA02 in patients with non-cystic fibrosis bronchiectasis ('NCFB') and chronic pulmonary Pseudomonas aeruginosa ('P. aeruginosa') infection. Topline data expected by year-end. Working towards initiating a pivotal bronchiectasis trial in 2025 for chronic pulmonary P. aeruginosa infection....'We plan to meet with the U.S. FDA to align on the design of a pivotal Phase 3 bronchiectasis study for inhaled AP-PA02 as a pulmonary disease therapeutic which we are working towards initiating in 2025.'"

Enrollment closed • New P3 trial • P2 data • Infectious Disease • Non‐Cystic Fibrosis Bronchiectasis

Armata Pharmaceuticals Announces Structural Biology Publication (PRNewswire) - "Armata Pharmaceuticals...today announced a paper in Communications Biology, published by Nature Portfolio. The publication, titled, 'Cryo-EM analysis of Pseudomonas phage Pa193 structural components,' describes the structure of phage Pa193. Pa193 is representative of a family of phages present in Armata's multi-phage clinical candidate, AP-PA02, which the company is developing to treat chronic Pseudomonas aeruginosa infections in patients with cystic fibrosis (CF) or non-cystic fibrosis bronchiectasis (NCFB)."

Clinical data • Cystic Fibrosis • Non‐Cystic Fibrosis Bronchiectasis

Armata Pharmaceuticals Announces Presentation at the 2024 Military Health System Research Symposium (PRNewswire) - "Armata Pharmaceuticals...will deliver a poster presentation at the 2024 Military Health System Research Symposium (MHSRS), which is being held August 26-29 in Kissimmee, FL....The poster provides an overview of Armata's two distinct phage development programs, inhaled AP-PA02 (Pseudomonas aeruginosa bronchiectasis) and intravenous AP-SA02 (Staphylococcus aureus (S. aureus) bacteremia), which are being or have been evaluated in three distinct double-blind, placebo-controlled Phase 2 clinical trials.... Enrollment of the diSArm study is 80% complete, and Armata anticipates completing enrollment by the end of 2024....We look forward to advancing both AP-SA02 and AP-PA02 into pivotal Phase 3 trials next year with the hope of introducing a distinct new class of anti-infectives to patient care....Promising data for both phage candidates is expected to be utilized for planning pivotal Phase 3 clinical trials in 2025."

Enrollment status • New P3 trial • P2 data • P3 data • Bronchiectasis • Infectious Disease

Tailwind: Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection (clinicaltrials.gov) - P2 | N=48 | Completed | Sponsor: Armata Pharmaceuticals, Inc. | Recruiting ➔ Completed

Trial completion • Bronchiectasis • Genetic Disorders • Immunology • Infectious Disease • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases

Armata Pharmaceuticals Announces Completion of Enrollment of Phase 2 Tailwind Study of Inhaled AP-PA02 in Non-Cystic Fibrosis Bronchiectasis Subjects with Chronic Pulmonary Pseudomonas aeruginosa Infection (PRNewswire) - "Armata Pharmaceuticals, Inc...today announced that it has achieved full enrollment in its Tailwind Phase 2 clinical study of inhaled AP-PA02 in patients with NCFB and chronic pulmonary Pseudomonas aeruginosa (P. aeruginosa) infection. The last patient final follow-up visit is scheduled for August 7, 2024. Armata anticipates topline data from the Tailwind study in the second half of 2024...'We look forward to sharing topline data as soon as it becomes available and plan to meet with the FDA shortly thereafter on the design of a pivotal Phase 3 study, which we are planning to initiate in 2025.'"

Enrollment closed • New P3 trial • P2 data • Trial status • Bronchiectasis • Non‐Cystic Fibrosis Bronchiectasis

Armata Pharmaceuticals Announces First Quarter 2024 Results and Provides Corporate Update (PRNewswire) - "Manuscript of results from SWARM-P.a., the completed Phase 1b/2a clinical trial of inhaled AP-PA02 in patients with cystic fibrosis and chronic pulmonary P. aeruginosa infection, expected to be submitted to a peer-reviewed journal in the second quarter of 2024...I am pleased to report that enrollment of our Phase 2 Tailwind study in subjects with NCFB continues to progress in line with projected timelines."

Enrollment status • P1/2 data • Cystic Fibrosis • Non‐Cystic Fibrosis Bronchiectasis

Tailwind: Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Armata Pharmaceuticals, Inc. | Trial completion date: Feb 2024 ➔ Aug 2024 | Trial primary completion date: Feb 2024 ➔ Jul 2024

Trial completion date • Trial primary completion date • Bronchiectasis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases

Armata Pharmaceuticals Announces Fourth Quarter and Full-Year 2023 Results and Provides Corporate Update (PRNewswire) - "Reported that analysis of data from the SWARM-P.a. clinical trial of AP-PA02 in cystic fibrosis patients with Pseudomonas aeruginosa respiratory infections, together with blinded trends from the ongoing Tailwind NCFB study....Plans to submit a manuscript detailing results from the SWARM-P.a. trial to a peer-reviewed journal in the first half of 2024....The Company recognized grant revenue of approximately $1.5 million for the three months ended December 31, 2023, which represents Medical Technology Enterprise Consortium's share of the costs incurred for the Company's AP-SA02 program for the treatment of Staphylococcus aureus bacteremia."

Commercial • P1/2 data • Trial status • Cystic Fibrosis • Non‐Cystic Fibrosis Bronchiectasis

Armata Pharmaceuticals Announces $35 Million Secured Credit Agreement with Innoviva (PRNewswire) - "Armata Pharmaceuticals...today announced that it has entered into a secured credit agreement with Innoviva Strategic Opportunities LLC, a wholly-owned subsidiary of Innoviva, Inc....Armata's largest shareholder. The gross proceeds to be received by the Company at closing are $35 million before deducting transaction-related expenses....This financing will enable Armata to fully enroll both ongoing Phase 2 trials, one in acute bacteremia and one in non-cystic fibrosis bronchiectasis, and prepare the Company for two pivotal trials....The credit agreement provides for a secured term loan facility in an aggregate amount of $35 million at an interest rate of 14.0% per annum with a maturity date of June 4, 2025."

Financing • Non‐Cystic Fibrosis Bronchiectasis

Armata Pharmaceuticals Announces Presentation at the 6th Annual Bacteriophage Therapy Summit (PRNewswire) - "Armata Pharmaceuticals...today announced that Mina Pastagia, M.D., Chief Medical Officer, will deliver a presentation at the 6th Annual Bacteriophage Therapy Summit, which is being held February 27-29 in Boston....Dr. Pastagia's presentation will cover a range of topics related to Armata's ongoing development programs, including: The similarities of phage distribution and phage kinetics between cystic fibrosis and non-cystic fibrosis bronchiectasis (NCFB) subjects who were administered Armata's nebulized phage candidate, AP-PA02."

Clinical • Cystic Fibrosis • Non‐Cystic Fibrosis Bronchiectasis

SWARM-Pa: Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis (clinicaltrials.gov) - P1/2 | N=29 | Completed | Sponsor: Armata Pharmaceuticals, Inc. | Phase classification: P1b/2a ➔ P1/2

Phase classification • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Armata Pharmaceuticals Announces Third Quarter 2023 Results and Provides Corporate Update (PRNewswire) - "Regarding AP-PA02, we are also seeing accelerating enrollment in our ongoing Tailwind Phase 2 study of PA02 in non-cystic fibrosis bronchiectasis....Grant Revenue. The Company recognized grant revenue of approximately $1.2 million for the three months ended September 30, 2023, which represents Medical Technology Enterprise Consortium ('MTEC')'s share of the costs incurred for the Company's AP-SA02 program for the treatment of Staphylococcus aureus bacteremia."

Commercial • Enrollment status • Cystic Fibrosis

Armata Pharmaceuticals Announces Presentation of Topline Data from SWARM-P.a. Clinical Study at the North American Cystic Fibrosis Conference (PRNewswire) - "Armata Pharmaceuticals...today announced that topline data from the Company's Phase 1b/2a SWARM-P.a. clinical trial evaluating AP-PA02, a novel, inhaled multi-phage therapeutic for the treatment of chronic pulmonary Pseudomonas aeruginosa infections in people with cystic fibrosis (CF) will be mentioned during the North American Cystic Fibrosis Conference (NACFC) Plenary II session."

P1/2 data • Cystic Fibrosis

SWARM-Pa: Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis (clinicaltrials.gov) - P1b/2a | N=29 | Completed | Sponsor: Armata Pharmaceuticals, Inc. | Active, not recruiting ➔ Completed

Trial completion • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Armata Pharmaceuticals Announces Second Quarter 2023 Results and Provides Corporate Update (PRNewswire) - "Continued enrollment in the Phase 2 study ('Tailwind') of inhaled AP-PA02 in patients with non-cystic fibrosis bronchiectasis (NCFB) and chronic Pseudomonas aeruginosa respiratory infection. Further analyzed clinical data from the SWARM-P.a. study with the goal of advancing AP-PA02 into a Phase 2b/3 registrational study in cystic fibrosis (CF) patients in 2024."

Enrollment status • P2/3 data • Bronchiectasis • Cystic Fibrosis • Non‐Cystic Fibrosis Bronchiectasis

Armata Pharmaceuticals Announces Oral Presentation Detailing Results from the Phase 1b/2a SWARM-P.a. Clinical Trial at the 6th World Conference on Targeting Phage Therapy (PRNewswire) - "Armata Pharmaceuticals...today announced an oral presentation on the company's recently completed Phase 1b/2a SWARM-P.a. clinical trial at the 6th World Conference on Targeting Phage Therapy, which is being held June 1-2, 2023, in Paris."

P1/2 data • Cystic Fibrosis

Armata Pharmaceuticals Announces Positive Topline Data from Phase 1b/2a SWARM-P.a. Clinical Trial of Inhaled AP-PA02 in Patients with Cystic Fibrosis (PRNewswire) - P1b/2a | N=29 | SWARM-Pa (NCT04596319) | Sponsor: Armata Pharmaceuticals, Inc. | "Armata Pharmaceuticals...today announced positive topline results from the completed Phase 1b/2a SWARM-P.a. trial evaluating AP-PA02, a novel, inhaled multi-phage therapeutic for the treatment of chronic pulmonary Pseudomonas aeruginosa infections in cystic fibrosis patients....'The data from our SWARM-P.a. study gives us confidence that the pharmacokinetics of inhaled phage are predictable and suggest that optimized exposures will correlate with bacterial load reduction'....Data indicate that AP-PA02 was well-tolerated with a treatment emergent adverse event (TEAE) profile similar to placebo. Only mild, self-limited adverse events possibly related to study drug were reported in a few subjects....Armata also announced today that it has dosed the first subject in its Tailwind study of nebulized AP-PA02 in patients with non-cystic fibrosis bronchiectasis (NCFB)."

P1/2 data • Cystic Fibrosis • Non‐Cystic Fibrosis Bronchiectasis • Respiratory Diseases

Armata surges 15% as inhaled bacterial infection drug shows promise in lung disorder patients (SeekingAlpha) - "Armata Pharmaceuticals...said its inhaled bacterial infection drug for lung disorder was well-tolerated with a treatment emergent adverse event (TEAE) profile similar to placebo in a phase 1b/2a trial....The study, dubbed SWARM-P.a., evaluated the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of AP-PA02....ARMP +15.94% to $3.20 premarket March 6."

Stock price • Cystic Fibrosis • Respiratory Diseases

Armata Pharmaceuticals Announces Completion of its Phase 1b/2a ’SWARM-P.a.’ Study of Inhaled AP-PA02 in Cystic Fibrosis Subjects with Chronic Pulmonary Pseudomonas aeruginosa Infection (PRNewswire) - "Armata Pharmaceuticals...today announced that the last subject has completed the company's Phase 1b/2a 'SWARM-P.a.' clinical trial of its lead candidate, AP-PA02, in cystic fibrosis (CF) subjects with chronic pulmonary Pseudomonas aeruginosa infection....'We anticipate topline data in the first quarter of 2023.'"

P1/2 data • Trial completion • Cystic Fibrosis

Tailwind: Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Armata Pharmaceuticals, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Bronchiectasis • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases

SWARM-Pa: Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis (clinicaltrials.gov) - P1b/2a | N=29 | Active, not recruiting | Sponsor: Armata Pharmaceuticals, Inc. | Recruiting ➔ Active, not recruiting | N=48 ➔ 29 | Trial completion date: Mar 2022 ➔ Mar 2023 | Trial primary completion date: Mar 2022 ➔ Dec 2022

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases

Tailwind: Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Armata Pharmaceuticals, Inc.

New P2 trial • Bronchiectasis • Cystic Fibrosis • Fibrosis • Genetic Disorders • Immunology • Infectious Disease • Non‐Cystic Fibrosis Bronchiectasis • Pulmonary Disease • Respiratory Diseases

Armata Pharmaceuticals Announces Third Quarter 2022 Results and Provides Corporate Update (PRNewswire) - "SWARM-P.a. enrolling final Phase 2 MAD cohort evaluating AP-PA02 in cystic fibrosis. AP-PA02 Phase 2 non-cystic fibrosis bronchiectasis (NCFB) study progressing toward site activation and first patient dosed. 'During the third quarter, we have made significant progress in the SWARM-P.a. study. We now anticipate enrolling the last subject in the fourth quarter with top-line data expected in early 2023,'..."

Enrollment status • P2 data • Cystic Fibrosis • Non‐Cystic Fibrosis Bronchiectasis