ARMP

LOS ANGELES, Aug. 12, 2026 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a late 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 second quarter ended June 30, 2026, and provided a corporate update. "We continue to finalize activities required to initiate a pivotal Phase 3 superiority study of AP-SA02 in complicated S. aureus bacteremia in the second half of 2026," said Dr. Deborah Birx, Chief Executive Officer of Armata. "We recently submitted the Phase 3 protocol to the FDA, responded to the Agency's End-of-Phase 2 meeting minutes, and continued to advance manufacturing, each of these key milestones supporting study initiation. Complicated S. aureus bacteremia is associated with substantial morbidity and mortality, underscoring the need for new treatments. We believe AP-SA02, a novel intravenous phage therapeutic, has the potential to be a valuable and differentiated approach for patients in need." "We also achieved several additional important milestones for AP-SA02, including FDA agreement on our Agreed Initial Pediatric Study Plan, granting of Fast Track designation by the FDA, and receipt of additional non-dilutive funding from our partners at the U.S. Department of War. We were pleased to promote David House to Chief Financial Officer, ensuring we have the financial leadership in place to execute our late-stage clinical development goals," concluded Dr. Birx. Second Quarter 2026 and Recent Developments: Clinical, Regulatory, Manufacturing, and Operational Progress Armata has made significant progress across clinical, regulatory, manufacturing, and operational fronts supporting advancement of AP-SA02, the Company's intravenously administered Staphylococcus aureus ("S. aureus") multi-phage product candidate, toward a Phase 3 superiority study for adjunct treatment of complicated bacteremia caused by methicillin-sensitive S. aureus ("MSSA") or methicillin-resistant S. aureus ("MRSA"). Collectively, these milestones support the planned pivotal Phase 3 superiority study, expected to initiate in the second half of 2026, and designed to support a future Biologics License Application ("BLA") for AP-SA02. Clinical Submitted the complete Phase 3 superiority protocol to the U.S. Food and Drug Administration (the "FDA"), incorporating all comments received in the End-of-Phase 2 ("EOP2") meeting written response. Chemistry, Manufacturing, and Controls ("CMC") Submitted responses to all FDA comments raised in the EOP2 meeting written response. Completed the validation and certification of essential lot release assays for drug substance and drug product. Completed four engineering runs of AP-SA02 at the Company's in-house current Good Manufacturing Practices ("cGMP") manufacturing facility in Los Angeles, CA. Production of clinical trial material to support the planned Phase 3 clinical study is the next planned manufacturing step. Simplified drug product for enhanced ease of use at the bedside and potential future U.S. Department of War ("DoW") forward deployment. Key Regulatory Milestones FDA granted Fast Track designation to AP-SA02 for adjunct treatment of complicated bacteremia caused by MSSA or MRSA, advancing AP-SA02 on a faster path to potential approval and patient access. Received agreement from the FDA on an Agreed Initial Pediatric Study Plan ("Agreed iPSP") which establishes the agreed regulatory framework for the future evaluation of AP-SA02 for the adjunct treatment of SAB in pediatric patients. Funding Continued support from the DoW: Received $2.5 million of additional non-dilutive funding from the DoW i to support AP-SA02. These funds are a continuation of the previously announced award from the DoW, bringing the total funding received to date under this award to $28.7 million, and are intended to support activities related to the Company's continued preparation and readiness for its planned Phase 3 clinical study. Separate from the existing or any potential new DoW award, the Company continues to pursue and evaluate other funding pathways to support the execution of the planned Phase 3 clinical study. Executive Leadership and Corporate Governance Promoted David House to Chief Financial Officer. Mr. House has served as the Company's Senior Vice President, Finance and Principal Financial Officer since August 2024. Appointed accomplished healthcare executive Daniel B. Gilmer, Ph.D. to the Board of Directors bringing experience in commercialization (Pfizer, Inc.), management consulting (McKinsey & Co.), and research (Rockefeller University, National Institutes of Health). Publications Further advanced bacteriophage science through the publication of a paper, titled, "Structural atlas of Pakpunavirus P7-1 reveals determinants of virion stability and genome ejection" in Communications Biology, a peer-reviewed journal from Nature Portfolio. The paper describes the structure of phage P7-1, included in Armata's Pseudomonas aeruginosa phage cocktail, AP-PA02. Second Quarter 2026 Financial Results Grant and Award Revenue. The Company recognized grant and award revenue of $2.5 million for the three months ended June 30, 2026, as compared to $2.2 million in the comparable period in 2025. This represents the Medical Technology Enterprise Consortium's share of the costs incurred for the Company's AP-SA02 program for the treatment of SAB. Research and Development. Research and development expenses for the three months ended June 30, 2026 were approximately $7.6 million, compared to approximately $6.4 million for the comparable period in 2025. The increase primarily reflected higher non-cash stock-based compensation primarily related to option grants issued after the second quarter of 2025. General and Administrative. General and administrative expenses for the three months ended June 30, 2026 were approximately $5.2 million, compared to approximately $2.6 million for the comparable period in 2025. The increase primarily reflected higher non-cash stock-based compensation primarily related to option grants issued after the second quarter of 2025. Loss from Operations. Loss from operations for the three months ended June 30, 2026 was approximately $10.3 million, compared to a loss from operations of approximately $6.8 million for the comparable period in 2025. The increase primarily reflected the higher research and development and general and administrative expenses described above, partially offset by higher grant and award revenue. Other Income (Expense). Other income, net, for the three months ended June 30, 2026 was approximately $84.5 million, compared with other expense, net, of approximately $9.5 million for the comparable period in 2025. Other income in the second quarter of 2026 primarily reflected a $91.0 million non-cash gain from the change in fair value of the Convertible Loan, partially offset by $6.6 million of interest expense. Net Income (Loss). The net income for the second quarter of 2026 was $74.1 million, or $2.02 earnings per share on a basic basis and a ($0.27) loss per share on a diluted basis, as compared to a net loss of ($16.3) million, or $(0.45) loss per share on a basic and diluted basis, for the comparable period in 2025. Cash and Cash Equivalents. As of June 30, 2026, Armata held approximately $24.0 million of unrestricted cash and cash equivalents, compared to $8.7 million as of December 31, 2025. The increase primarily reflected the $25.0 million term loan funded in May 2026, approximately $2.4 million of net proceeds under the Company's at-the-market offering program and approximately $1.2 million of proceeds from stock option exercises, partially offset by cash used in operations. As of August 06, 2026, 37,181,979 common shares were outstanding. About AP-SA02 Armata is developing AP-SA02, a fixed multi-phage cocktail, for the adjunct treatment of complicated Staphylococcus aureus bacteremia caused by methicillin-sensitive S. aureus (MSSA) or methicillin-resistant S. aureus (MRSA). AP-SA02 has received Qualified Infectious Disease Product (QIDP) and Fast Track designations from the FDA. 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 S. aureus bacteremia. Positive results from the Phase 2a diSArm study were highlighted in a late-breaking oral presentation at IDWeek 2025™ in October 2025. The Company plans to advance AP-SA02 into a Phase 3 superiority study in complicated SAB, anticipated to initiate in the second half of 2026. About Armata Pharmaceuticals, Inc. Armata is a late 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, S. aureus, and other important 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; Armata's planned clinical trials; 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 25, 2026, 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 [email protected] Investor Relations: Joyce AllaireLifeSci Advisors, [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/armata-pharmaceuticals-announces-financial-results-for-the-second-quarter-2026-and-provides-a-corporate-update-302847580.html

Entered into secured credit agreement with Innoviva for $25 million maturing in 2029 LOS ANGELES, May 13, 2026 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a late 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 first quarter ended March 31, 2026, and provided a corporate update. "Our top priority in 2026 is advancing Armata's lead Staphylococcus aureus ("S. aureus") therapeutic phage candidate, AP-SA02, into a Phase 3 superiority study in complicated S. aureus bacteremia ("SAB")," said Dr. Deborah Birx, Chief Executive Officer of Armata. "We are focused on initiating a rigorously designed and operationally efficient study designed to support a future Biologics License Application ("BLA") submission and potential registration. If successful, AP-SA02 has the potential to offer an important new treatment option for patients facing this serious and often life-threatening infection. We believe this program will establish a foundation for expanding our phage platform into additional indications. Ultimately, we believe there is a significant opportunity for this innovative antibacterial technology to have a broad impact on antimicrobial resistance, which represents one of the significant public health challenges of modern medicine." "I also want to highlight other important recent developments including the granting by the U.S. Food and Drug Administration (the "FDA") of both Qualified Infectious Disease Product ("QIDP") and Fast Track Designation for AP-SA02. Additionally, the recent appointment of Dr. Daniel Gilmer to Armata's Board brings commercial leadership and experience as we continue to move toward potential registration and commercialization. We are pleased to have the ongoing backing of Innoviva, our largest shareholder who has supported us since 2020, in providing additional financing that will help us to advance AP-SA02, and we are continuing to pursue additional sources of funding, including non-dilutive sources," concluded Dr. Birx. First Quarter 2026 and Recent Developments: Clinical and Regulatory Preparations are ongoing to advance AP-SA02, a novel intravenously administered multi-phage therapeutic, into a Phase 3 superiority study in complicated SAB caused by methicillin-sensitive S. aureus ("MSSA") or methicillin resistant S. aureus ("MRSA"). The study is expected to initiate in the second half of 2026. Announced that the FDA granted Fast Track Designation to AP-SA02 for adjunct treatment of complicated bacteremia caused by MSSA or MRSA, advancing AP-SA02 on a faster path to potential approval and patient access. Facilitates the development and expedites the review of investigational therapies that treat serious conditions and fill an unmet medical need. Provides for more frequent interactions with the FDA regarding all aspects of a designated drug's clinical development program, supporting a more efficient path to registration. Allows for rolling review of a BLA, meaning completed sections may be submitted and reviewed on an ongoing basis rather than waiting for the full application. Fast Track-designated programs may also be eligible for Accelerated Approval and Priority Review if supported by clinical data at the time of BLA submission, further supporting a faster path to potential approval and patient access. Announced that the FDA granted AP-SA02 for intravenous use as a QIDP for adjunct treatment of complicated SAB caused by MSSA or MRSA. To achieve QIDP designation, a drug candidate must be intended to treat serious or life-threatening infections, particularly those caused by bacteria and fungi that are resistant to treatment, or that treat qualifying resistant pathogens identified by the FDA. The QIDP designation makes AP-SA02 eligible to benefit from certain incentives for the development of new antibacterials provided under the Generating Antibiotic Incentives Now (GAIN) Act, including an additional five-year extension of Hatch-Waxman market exclusivity. Financial On May 12, 2026, entered into a secured credit agreement with Innoviva Strategic Opportunities LLC, a wholly owned subsidiary of Innoviva, Inc., Armata's largest shareholder, for a loan of $25.0 million that will mature on January 11, 2029. Proceeds from the transaction will be used to continue to advance development of AP-SA02. On January 23, 2026, Armata entered into amendments to the March 2025 Credit Agreement, the 2024 Credit Agreement, the 2023 Credit Agreement, and the Convertible Credit Agreement with Innoviva Strategic Opportunities LLC, extending the maturity dates to June 1, 2027. In exchange for such amendments, the Company also amended certain outstanding Innoviva warrants to extend their expiration dates to January 26, 2031, and amended the related voting agreement to align with the revised warrant expiration date or FDA approval, as applicable. Corporate Governance Appointed biopharmaceutical commercial executive Daniel B. Gilmer, Ph.D. to Board of Directors. Dr. Gilmer brings 20 years of experience in healthcare commercialization (Pfizer, Inc.), management consulting (McKinsey & Co.), and academic research (Rockefeller University, National Institutes of Health). At Pfizer: Most recently led an organization responsible for quality and promotional review across 50+ U.S. brands. Launched PAXLOVID™ following approval by the FDA. In Inflammation & Immunology Commercial Development, helped shape strategy for a portfolio of rheumatology and immunology assets. Contributed to COVID-19 vaccine-enabling operating model and R&D portfolio strategy. Authored multiple peer-reviewed publications on phage lysins and antimicrobial resistance. Presentations and Publications Further advanced bacteriophage science through presentations and publications. Published a paper, titled, "Structural atlas of Pakpunavirus P7-1 reveals determinants of virion stability and genome ejection" in Communications Biology, a peer-reviewed journal from Nature Portfolio. The paper describes the structure of phage P7-1, included in Armata's Pseudomonas aeruginosa phage cocktail, AP-PA02. Presented at the 8th Annual Bacteriophage Therapy Summit held on March 24-26 in London, UK. First Quarter 2026 Financial Results Grant and Award Revenue. The Company recognized grant and award revenue of $0.8 million for the three months ended March 31, 2026, as compared to $0.5 million in the comparable period in 2025. This represents the Medical Technology Enterprise Consortium's share of the costs incurred for the Company's AP-SA02 program for the treatment of SAB. Research and Development. Research and development expenses for the three months ended March 31, 2026 were approximately $6.1 million compared to approximately $5.4 million for the comparable period in 2025. The increase was primarily due to a large credit recorded in the prior year period related to AP-PA02 NCFB trial costs. Excluding this prior period credit, research and development expenses increased modestly period over period, reflecting ongoing AP-SA02 program activities. General and Administrative. General and administrative expenses for the three months ended March 31, 2026 were approximately $3.5 million, compared to approximately $3.3 million for the comparable period in 2025. The increase of $0.2 million is primarily related to an increase in stock-based compensation expense. Loss from Operations. Loss from operations for the three months ended March 31, 2026 was approximately $8.8 million, compared to a loss from operations of approximately $8.2 million for the comparable period in 2025. Net Loss. The net loss for the first quarter of 2026 was $115.3 million, or $3.16 loss per share on a basic and diluted basis, as compared to a net loss of $6.5 million, or $0.18 loss per share basic and $0.20 loss per share diluted, for the comparable period in 2025. Cash and Cash Equivalents. As of March 31, 2026, Armata held approximately $4.8 million of unrestricted cash and cash equivalents, compared to $8.7 million as of December 31, 2025. As of May 8, 2026, approximately 36.7 million common shares were outstanding. About Armata Pharmaceuticals, Inc. Armata is a late 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, S. aureus, and other important 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; Armata's planned clinical trials; 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 25, 2026, 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:https://www.prnewswire.com/news-releases/armata-pharmaceuticals-announces-first-quarter-2026-results-and-provides-corporate-update-302771303.html

LOS ANGELES, March 25, 2026 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a late 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, 2025. Fourth Quarter 2025 Financial Results Grant Revenue. The Company recognized grant revenue of $1.1 million for the three months ended December 31, 2025 as compared to $1.2 million in the comparable period in 2024, which represents MTEC's share of the costs incurred for the Company's AP-SA02 program for the treatment of Staphylococcus aureus bacteremia. Research and Development. Research and development expenses for the three months ended December 31, 2025 were approximately $6.1 million as compared to approximately $8.5 million for the comparable period in 2024. The decrease was primarily driven by lower clinical trial activity, including reduced spend on AP-PA02 and AP-SA02 programs, as well as lower personnel-related costs compared to the prior year period. General and Administrative. General and administrative expenses for the three months ended December 31, 2025 were approximately $3.4 million as compared to approximately $3.3 million for the comparable period in 2024. The increase was mainly related to an increase of $0.2 million in legal expenses during the fourth quarter of 2025, offset in part by a decrease of $0.1 million in lease expense. Impairment Expenses. During the year ended December 31, 2025, we recognized a $5.4 million impairment expense related to our office and research and development space under a non-cancelable operating lease in Marina del Rey, California. The impairment resulted from changes in the anticipated timeline in our plan to sublease the vacated space. There was no impairment of long-lived assets during the year ended December 31, 2024. Loss from Operations. Loss from operations for the three months ended December 31, 2025 was approximately $13.8 million as compared to a loss from operations of approximately $10.5 million for the comparable period in 2024. The increase in operating loss was primarily driven by the $5.4 million impairment charge recognized in the current period, partially offset by lower research and development expenses. Net Income (Loss). The net loss for the fourth quarter of 2025 was $124.3 million, or $(3.42) per share on a basic and diluted basis, as compared to a net income of $2.6 million, or $0.07 per share on a basic and $(0.23) per share on a diluted basis, for the comparable period in 2024. The net loss for the quarter ended December 31, 2025 included non-cash loss from the changes in fair value of convertible loan of $105.8 million, as compared to a non-cash gain from the changes in fair value of convertible loan of $14.2 million for the comparable period in 2024, non-cash impairment expense of $5.4 million and non-cash gain from debt extinguishment of $2.2 million for the comparable period in 2024. Cash and Equivalents. As of December 31, 2025, Armata held approximately $14.1 million of cash and cash equivalents and restricted cash, as compared to $14.8 million as of December 31, 2024. On January 23, 2026, Armata entered into amendments to the March 2025 Credit Agreement, the 2024 Credit Agreement, the 2023 Credit Agreement, and the Convertible Credit Agreement with Innoviva Strategic Opportunities LLC, extending the maturity dates to June 1, 2027. In addition, the Company amended certain outstanding Innoviva warrants to extend their expiration dates to January 26, 2031, and amended the related voting agreement to align with the revised warrant expiration date or FDA approval, as applicable. The Company's audited financial statements for the year ended December 31, 2025, included in its Annual Report on Form 10-K, contain an audit opinion from its independent registered public accounting firm that includes an explanatory paragraph relating to the Company's ability to continue as a going concern. This announcement is made pursuant to the disclosure requirements of NYSE American Company Guide Sections 401(h) and 610(b). As of March 18, 2026, there were approximately 36.6 million common shares outstanding. About Armata Pharmaceuticals, Inc. Armata is a late 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 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; Armata's planned clinical trials; 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 25, 2026, 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:https://www.prnewswire.com/news-releases/armata-pharmaceuticals-announces-fourth-quarter-and-full-year-2025-financial-results-302725089.html

LOS ANGELES, March 19, 2026 /PRNewswire/ -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) ("Armata" or the "Company"), a late 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 it will delay the announcement of its financial results for its fourth quarter and full-year ended December 31, 2025, and provided a corporate update. The Company requires additional time to complete its financial reporting and anticipates filing its Annual Report on Form 10-K on or before March 31, 2026, the due date. Armata also made the following announcement related to recent developments with its business. Recent Developments: Announced that the U.S. Food and Drug Administration (the "FDA") has granted AP-SA02, the Company's Staphylococcus aureus ("S. aureus") multi-phage product candidate, for intravenous use as a Qualified Infectious Disease Product ("QIDP") for adjunct treatment of complicated S. aureus bacteremia ("SAB") caused by methicillin-sensitive S. aureus ("MSSA") or methicillin resistant S. aureus ("MRSA"). To achieve QIDP designation, a drug candidate must be intended to treat serious or life-threatening infections, particularly those caused by bacteria and fungi that are resistant to treatment, or that treat qualifying resistant pathogens identified by the FDA. The QIDP designation makes AP-SA02 eligible to benefit from certain incentives for the development of new antibacterials provided under the Generating Antibiotic Incentives Now (GAIN) Act, including an additional five-year extension of Hatch-Waxman market exclusivity. The Company has submitted to the FDA a request for Fast Track Designation for AP-SA02, which, if granted, will provide an opportunity for more frequent meetings and communication with the FDA, priority and rolling review, leading to potential accelerated approval of its Biologics License Application ("BLA"). Announced the conclusion of an End-of-Phase 2 ("EOP2") written response from the FDA and plans to advance AP-SA02 into a Phase 3 clinical study in complicated SAB. The FDA confirmed that the safety and efficacy data from Armata's Phase 2a diSArm study are sufficient to start a Phase 3 trial. The FDA provided critical guidance on key elements of the Phase 3 study design, which will assess the superiority of AP-SA02 over the current standard of care for the treatment of complicated SAB. The Phase 3 study is anticipated to initiate in the second half of 2026. Armata is addressing the FDA's comments, including on Chemistry, Manufacturing, and Controls ("CMC") and aligning them with the Company's existing Phase 3 manufacturing and quality strategy. The FDA also included recommendations for the future BLA submission. Announced that its state-of-the-art current Good Manufacturing Practice ("cGMP") manufacturing facility in Los Angeles, California, has been formally commissioned. Full production runs have been successfully completed. Armata's approximately 56,000 square foot facility includes 10,000 square feet of cGMP clean rooms, an automated fill and finish suite, and quality control laboratories, to support future clinical trials and full commercialization as well as potential partnering and contract manufacturing opportunities. Aligns with the federal government's focus on onshoring manufacturing to secure the supply chain of essential medicines for the health and safety of the American people. Addresses the need to confront the growing antimicrobial resistance crisis and the risk of bacterial escape from current antibiotics. Highlighted positive results from the Phase 2a diSArm study of Armata's lead therapeutic phage candidate, AP-SA02, as a potential treatment for complicated SAB, at IDWeek 2025TM. The late-breaking oral presentation was delivered by Dr. Loren G. Miller, M.D., M.P.H., Professor of Medicine, David Geffen School of Medicine at UCLA, Chief, Division of Infectious Diseases at Harbor-UCLA Medical Center and the Lundquist Institute. AP-SA02 combined with Best Available Antibiotic Therapy ("BAT") had a higher and earlier cure rate compared to placebo (BAT alone) in patients with complicated SAB at day 12 as assessed by both blinded site investigators and independent adjudicators. Additionally, patients who received AP-SA02 demonstrated 100% response rate without relapse one week post-BAT and 28 days later at End of Study when compared to the placebo (BAT alone) group which showed approximately 25% lack of response or relapse at both timepoints. AP-SA02 was well-tolerated with clinical efficacy against both MRSA and MSSA, and patients treated with AP-SA02 showed trends toward rapid normalization of key predictors of mortality and complications in SAB including C-reactive protein and interleukin-10, shorter time to negative blood culture, quicker time to resolution of signs and symptoms at the infection site, and shorter intensive care unit and hospital utilization. Participated in a key opinion leader (KOL) webinar, "Redefining SoC in Complicated Staph. aureus Bacteremia to Unlock a Real Opportunity." The webinar was hosted by Debanjana Chatterjee, PhD, from Jones Research, and featured prominent infectious disease specialist Dr. Vance G. Fowler, Jr., MD, from Duke University School of Medicine. Dr. Fowler discussed the complicated SAB landscape and the potential of AP‑SA02. Continued to advance bacteriophage science through collaboration with Dr. Gino Cingolani, Anderson Family Endowed Chair in Medical Education, Research & Patient Care, and Professor in the Department of Biochemistry and Molecular Genetics, The University of Alabama at Birmingham. Reflects Armata's commitment to understanding phage structure and function, enhancing the Company's knowledge of fundamental phage biology to enable the development of novel antibacterial therapies. "The major highlight since our last quarterly update was the End-of-Phase 2 meeting with the FDA, which enabled us to reach alignment with the Agency on a plan forward for AP-SA02 in complicated S. aureus bacteremia," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "The compelling results from our Phase 2a diSArm study demonstrated that AP-SA02 was well-tolerated with clinical efficacy against both methicillin-resistant and methicillin-sensitive S. aureus, and patients treated with AP-SA02 showed trends toward rapid normalization of key predictors of mortality and complications in SAB. Having gained alignment with the FDA, we are working to initiate an efficient, rigorously designed Phase 3 superiority study later this year that, if successful, we believe would bring new hope to people who are suffering from this common, extremely severe, and often deadly bacterial infection. Furthermore, if successful, we believe it could create an entirely new approach to combatting antimicrobial resistance and enable a pathway to expand into additional clinical indications and novel phage cocktails." "Additionally, we are pleased to have received QIDP designation from the FDA, reflecting the Agency's recognition of the significant unmet needs of patients with S. aureus bacteremia and the potential of AP-SA02 to improve upon the current standard of care. We look forward to continuing to work closely with the Agency as we advance AP-SA02 toward a superiority study designed to support a BLA and potential registration." "Finally, I would again like to express my gratitude to Innoviva, our largest shareholder, and the U.S. Department of Defense, for their continued support to advance Armata's clinical pipeline of innovative phage product candidates," Dr. Birx concluded. About Armata Pharmaceuticals, Inc. Armata is a late 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 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; Armata's planned clinical trials; 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:https://www.prnewswire.com/news-releases/armata-pharmaceuticals-delays-announcement-of-fourth-quarter-and-full-year-2025-results-and-provides-corporate-update-302718599.html

LOS ANGELES, Nov. 12, 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 third quarter ended September 30, 2025, and provided a corporate update. Third Quarter 2025 and Recent Developments: Highlighted positive results from Phase 2a "diSArm" study of Armata's lead therapeutic phage candidate, AP-SA02, as a potential treatment for complicated Staphylococcus aureus ("S. aureus") bacteremia ("SAB") at IDWeek 2025TM, on October 22 in Atlanta, Georgia. The abstract was accepted as a late-breaking abstract for oral presentation and was presented by Dr. Loren G. Miller, M.D., M.P.H., Professor of Medicine, David Geffen School of Medicine at UCLA, Chief, Division of Infectious Diseases at Harbor-UCLA Medical Center and the Lundquist Institute. AP-SA02 combined with Best Available Antibiotic Therapy ("BAT") had a higher and earlier cure rate compared to placebo (BAT alone) in patients with complicated SAB at day 12 as assessed by both blinded site investigators and independent adjudicators. Additionally, patients who received AP-SA02 demonstrated 100% response rate without relapse one week post-BAT and 28 days later at End of Study when compared to the placebo (BAT alone) group which showed approximately 25% lack of response or relapse at both timepoints. AP-SA02 was well-tolerated with clinical efficacy against both methicillin-resistant S. aureus and methicillin-sensitive S. aureus, and patients treated with AP-SA02 showed trends toward rapid normalization of key predictors of mortality and complications in SAB including C-reactive protein and interleukin-10, shorter time to negative blood culture, quicker time to resolution of signs and symptoms at the infection site, and shorter intensive care unit and hospital utilization. Announced that its state-of-the-art current Good Manufacturing Practice ("cGMP") manufacturing facility in Los Angeles, California, has been formally commissioned. Full production runs have been completed with no issues or concerns. Armata's 56,000 square foot facility includes 10,000 square feet of cGMP clean rooms, an automated fill and finish suite, and quality control laboratories, to support future clinical trials and full commercialization as well as potential partnering and contract manufacturing opportunities. Aligns with the federal government's focus on onshoring manufacturing to secure the supply chain of essential medicines for the health and safety of the American people. Aligns with the need to confront the growing antimicrobial resistance crisis and the risk of bacterial escape from current antibiotics. Entered into a secured credit agreement with Innoviva Strategic Opportunities LLC, a wholly owned subsidiary of Innoviva, Inc., Armata's largest shareholder, for a loan of $15.0 million that will mature on January 11, 2029, the proceeds of which are being used to continue to advance development of AP-SA02. Further advanced bacteriophage science through a structural biology publication in the Journal of Molecular Biology. Participated in the H.C. Wainwright 27th Annual Global Investment Conference. "Compelling efficacy data from the Phase 1b/2a randomized controlled study of intravenously administered AP-SA02, including the favorable safety and tolerability profile, underscore the precision infection control enabled by Armata's well-characterized, high-purity phage cocktails, and provide strong rationale for advancement of AP-SA02 into late-stage clinical development," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "Subject to review and feedback from the U.S. Food and Drug Administration, we are committed to developing a superiority pivotal trial with the goal of introducing AP-SA02 as a new standard of care for complicated Staphylococcus aureus bacteremia, a common, extremely severe, and often deadly infection." "With the full commissioning of our state-of-the-art cGMP manufacturing facility in Los Angeles, California, we are now operationally ready to scale production for late-stage clinical development. We reiterate our commitment to U.S.-based manufacturing in support of the federal government's efforts to secure the pharmaceutical supply chain through onshore manufacturing of essential medicines. We have made tremendous progress this year advancing phage-based therapeutics as potential treatments for both acute and chronic bacterial infections, and with line-of-site to the potential initiation of a Phase 3 study in 2026, we believe we are well positioned to bring new hope to patients with significant unmet medical need, while creating long-term value for our shareholders," Dr. Birx concluded. Third Quarter 2025 Financial Results Grant and Award Revenue. The Company recognized grant and award revenue of $1.2 million for the three months ended September 30, 2025, as compared to $3.0 million in the comparable period in 2024. This represents the Medical Technology Enterprise Consortium's share of the costs incurred for the Company's AP-SA02 program for the treatment of SAB. Research and Development. Research and development expenses for the three months ended September 30, 2025 were approximately $5.8 million, compared to approximately $9.5 million for the comparable period in 2024 reflecting completion of two Phase 2 clincial trials and enhanced operational efficiency. 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 September 30, 2025 were approximately $3.1 million, compared to approximately $3.2 million for the comparable period in 2024. Loss from Operations. Loss from operations for the three months ended September 30, 2025 was approximately $7.8 million, compared to a loss from operations of approximately $9.8 million for the comparable period in 2024. Cash and Cash Equivalents. As of September 30, 2025, Armata held approximately $14.8 million of unrestricted cash and cash equivalents, compared to $9.3 million as of December 31, 2024. As of November 4, 2025, approximately 36.3 million common shares were 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 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:https://www.prnewswire.com/news-releases/armata-pharmaceuticals-announces-third-quarter-2025-results-and-provides-corporate-update-302613100.html

Agenus (AGEN) came out with quarterly earnings of $1.94 per share, missing the Zacks Consensus Estimate of $2.63 per share. This compares to a loss of $3.17 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -26.24%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.78 per share when it actually produced a loss of $1, delivering a surprise of -28.21%. Over the last four quarters, the company has surpassed consensus EPS estimates two times. Agenus, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $30.2 million for the quarter ended September 2025, missing the Zacks Consensus Estimate by 71.95%. This compares to year-ago revenues of $25.11 million. The company has topped consensus revenue estimates two times 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. Agenus shares have added about 45.3% since the beginning of the year versus the S&P 500's gain of 14.4%. While Agenus has outperformed 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 Agenus was mixed. 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 #3 (Hold) for the stock. So, the shares are expected to perform in line with 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 the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.21 on $72.55 million in revenues for the coming quarter and $0.61 on $229.95 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 36% 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, Armata Pharmaceuticals, Inc. (ARMP), has yet to report results for the quarter ended September 2025. This company is expected to post quarterly loss of $0.42 per share in its upcoming report, which represents a year-over-year change of -180%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Armata Pharmaceuticals, Inc.'s revenues are expected to be $1.38 million, down 53.5% 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 Agenus Inc. (AGEN) : Free Stock Analysis Report Armata Pharmaceuticals, Inc. (ARMP) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Exact Sciences (EXAS) came out with quarterly earnings of $0.24 per share, beating the Zacks Consensus Estimate of $0.13 per share. This compares to a loss of $0.21 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +84.62%. A quarter ago, it was expected that this molecular diagnostics company would post a loss of $0.02 per share when it actually produced earnings of $0.22, delivering a surprise of +1200%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Exact Sciences, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $850.74 million for the quarter ended September 2025, surpassing the Zacks Consensus Estimate by 4.97%. This compares to year-ago revenues of $708.66 million. The company has topped consensus revenue estimates four times 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. Exact Sciences shares have added about 15.1% since the beginning of the year versus the S&P 500's gain of 16.3%. While Exact Sciences 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 Exact Sciences was favorable. 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 #1 (Strong Buy) for the stock. So, the shares are expected to outperform 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 the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.22 on $829.33 million in revenues for the coming quarter and $0.38 on $3.16 billion 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 39% 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. Armata Pharmaceuticals, Inc. (ARMP), another stock in the same industry, has yet to report results for the quarter ended September 2025. This company is expected to post quarterly loss of $0.42 per share in its upcoming report, which represents a year-over-year change of -180%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Armata Pharmaceuticals, Inc.'s revenues are expected to be $1.38 million, down 53.5% 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 Exact Sciences Corporation (EXAS) : Free Stock Analysis Report Armata Pharmaceuticals, Inc. (ARMP) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

LOS ANGELES, Oct. 22, 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 highlighted positive results from its recently completed Phase 2a diSArm study of AP-SA02 as a potential treatment for complicated Staphylococcus aureus ("S. aureus") bacteremia ("SAB") in a late-breaking oral presentation at IDWeek 2025™. The abstract, titled, "A Phase 2a Randomized, Double-Blind, Controlled Trial of the Efficacy and Safety of an Intravenous (IV) Bacteriophage Cocktail (AP-SA02) vs. Placebo in Combination with Best Available Antibiotic Therapy (BAT) in Patients with Complicated Staphylococcus aureus Bacteremia," was accepted as a highly coveted late-breaking abstract for oral presentation, and was presented by Dr. Loren G. Miller, M.D., M.P.H., Professor of Medicine, David Geffen School of Medicine at UCLA, Chief, Division of Infectious Diseases at Harbor-UCLA Medical Center and the Lundquist Institute. "The results of the diSArm study confirm, for the first time in a randomized clinical trial, the efficacy of intravenous phage therapy for S. aureus bacteremia, and we are very pleased to highlight these compelling data in an oral presentation at IDWeek," stated Dr. Miller. "The results of this rigorously designed study provide strong rationale for advancement into a Phase 3 superiority study that, if successful, would support its use in clinical practice for Staphylococcus aureus bacteremia. High-purity, phage-based therapeutics like AP-SA02 have the potential to become the new standard of care for this common, extremely severe, and often deadly infection." "The positive results from the diSArm study represent another significant achievement for Armata as we aim to advance AP-SA02 into a pivotal trial," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "I would like to thank Dr. Miller and the other investigators who contributed to the efficient execution of the diSArm study, and I look forward to working with many of them on a proposed pivotal study next year. I would also like to thank Dr. Vance Fowler who served as the chair of the independent blinded adjudication committee that independently confirmed safety and efficacy findings throughout the Phase 2 trial. Finally, I would like to express my gratitude to the patients who participated in this important study, and acknowledge our partners at the U.S. Department of Defense, and our significant shareholder, Innoviva, who have each provided critical support to make this early breakthrough possible." Data highlights: The Phase 2a study enrolled and dosed 42 patients, with 29 randomized to AP-SA02 in addition to BAT and 13 to placebo (BAT alone). Methicillin-resistant S. aureus ("MRSA") was the causative pathogen in ~38% of both the AP-SA02 and placebo groups. Clinical response was assessed in the intent-to-treat (ITT) population at Test of Cure ("TOC") on day 12, one week post-BAT, and End of Study ("EOS") four weeks after BAT completion. Safety analysis also included data from the Phase 1b portion of the trial (n=8). Day 12 clinical response rates were higher in the AP-SA02 group — 88% (21/24) versus 58% (7/12) in the placebo group as assessed by blinded site investigators ("PI") (p = 0.047), and 83% (20/24) in the AP-SA02 group versus 58% (7/12) in the placebo group as assessed by the blinded Adjudication Committee ("AC"). Non-response/relapse rates were evaluated at the two later timepoints — one week post-BAT and EOS. No patients in the AP-SA02 group experienced non-response or relapse (0%) by either PI or AC assessment. In contrast, the placebo group showed 25% non-response/relapse at both timepoints reported by the PI (p = 0.017) and 22% non-response/relapse at one week post-BAT (p = 0.025) and 25% at EOS (p = 0.02) by the AC. Patients treated with AP-SA02 showed trends toward rapid normalization of C-reactive protein, shorter time to negative blood culture, quicker time to resolution of signs and symptoms at the infection site, shorter intensive care unit and hospital utilization. AP-SA02 was well-tolerated with no serious adverse events related to the study drug. Treatment-emergent adverse events occurred in 6% (2/35) and 0% (0/15) in the AP-SA02 and placebo groups, respectively: one patient with transient liver enzyme elevation and one patient with hypersensitivity that resolved with discontinuation of vancomycin. New findings demonstrate that the defined and reproducible genomic variants present in AP-SA02 Drug Product may provide an immediate advantage, enabling rapid, strain-specific response to each patient's S. aureus isolate. These characterized variants can expand from as little as 2% to dominance when infecting certain patient isolates in vitro, highlighting that these variants are favored for their enhanced ability to infect those strains and the importance of integrating this diversity into Armata's phage cocktail from the outset. This inherent flexibility may be central to achieving optimal therapeutic efficacy. Conclusions: AP-SA02, combined with BAT, had a higher and earlier cure rate compared to placebo in patients with complicated SAB at day 12 as assessed by both blinded site investigators and independent adjudicators. No patients who received AP-SA02 demonstrated non-response or relapse at one week post-BAT or at EOS, as assessed by both blinded site investigators and the independent adjudication committee, compared with approximately 25% in the placebo group. AP-SA02 appears safe with clinical efficacy against both MRSA and methicillin-sensitive S. aureus ("MSSA") and trends toward earlier resolution and shorter hospitalization, with no evidence of relapse four weeks post-therapy. Defined phage variants in AP-SA02 Drug Product ensure an intrinsic adaptive mechanism — a flexibility that may be key to achieving effective phage therapy from patient to patient. These results strongly support advancement into a pivotal Phase 3 trial that Armata plans to initiate in 2026, subject to review and feedback from the U.S. Food and Drug Administration (the "FDA"). The Company is engaged with the FDA regarding a potential superiority trial design. About IDWeek 2025™ IDWeek 2025™ is a joint annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS) and the Society of Infectious Diseases Pharmacists (SIDP). With the theme "Advancing Science, Improving Care," IDWeek features the latest science and bench-to-bedside approaches in prevention, diagnosis, treatment and epidemiology of infectious diseases, including HIV, across the lifespan. IDWeek 2025™ takes place October 19-22 in Atlanta, GA. For more information, visit www.idweek.org. About AP-SA02 and diSArm Study Armata is developing AP-SA02, a fixed multi-phage phage cocktail, for the treatment of complicated bacteremia caused by Staphylococcus aureus (S. aureus), including methicillin-sensitive S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA) strains. 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 S. aureus bacteremia. The results from the diSArm study are an important step forward in Armata's effort to confirm the potent antimicrobial activity of phage therapy and the completion of the study represents a significant milestone in the development of AP-SA02, moving Armata one step closer to introducing an effective new treatment option to patients suffering from complicated S. aureus bacteremia. The Phase 1b/2a clinical development of AP-SA02 was partially supported by a $26.2 million Department of Defense (DoD) award, received through the Medical Technology Enterprise Consortium (MTEC) and managed by the Naval Medical Research Command (NMRC) – Naval Advanced Medical Development (NAMD) with funding from the Defense Health Agency and Joint Warfighter Medical Research Program. 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 important 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:https://www.prnewswire.com/news-releases/armata-pharmaceuticals-highlights-positive-results-from-phase-2a-disarm-study-of-its-staphylococcus-aureus-bacteriophage-cocktail-ap-sa02-in-late-breaking-oral-presentation-at-idweek-2025-302590906.html

Entered into secured credit agreement with Innoviva for $15 million maturing in 2029 Announced positive topline results from the Phase 1b/2a diSArm trial for AP-SA02 LOS ANGELES, Aug. 12, 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 second quarter ended June 30, 2025, and provided a corporate update. Second Quarter 2025 and Recent Developments: On August 11, 2025, entered into a secured credit agreement with Innoviva Strategic Opportunities LLC, a wholly owned subsidiary of Innoviva, Inc., Armata's largest shareholder, for a loan of $15.0 million that will mature on January 11, 2029 Proceeds from the new financing transaction will be used to continue to advance development of Armata's lead Staphylococcus aureus ("S. aureus") therapeutic phage candidate, AP-SA02, a novel intravenously administered multi-phage therapeutic for the treatment of complicated S. aureus bacteremia On May 19, 2025, announced positive topline results from the Phase 1b/2a diSArm trial which evaluated AP-SA02 Study met all primary endpoints for safety, tolerability, and clinical response in the intent-to-treat population The 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 AP-SA02 administered intravenously every six hours for five days Armata plans to hold an end-of-Phase 2 Meeting with the U.S. Food and Drug Administration ("FDA") in the second half of this year to align on a superiority trial design that the Company intends to begin enrolling patients in a Phase 3 pivotal trial in 2026 Received an additional $4.65 million of non-dilutive funding pursuant to a previously announced U.S. Department of Defense award through the Medical Technology Enterprise Consortium ("MTEC") and managed by the Naval Medical Research Command – Naval Advanced Medical Development with funding from the Defense Health Agency and Joint Warfighter Medical Research Program Supports diSArm study close-out activities, as well as the preparation and execution of an end-of-Phase 2 meeting with FDA Further advanced bacteriophage science through presentations at: 2025 Military Health System Research Symposium (MHSRS), held on August 6 in Kissimmee, FL 26th Biennial Evergreen Phage Meeting, held on August 7 in Knoxville, TN "We achieved another significant milestone during the second quarter with positive topline data from our Phase 1b/2a diSArm study of AP-SA02, our high-purity, multi-phage therapeutic candidate that we are developing as a treatment for complicated S. aureus bacteremia," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "Notably, these data are the first clear evidence in a randomized controlled trial of the effectiveness of phage in treating a serious systemic bacterial infection, with demonstrated efficacy regardless of antibiotic resistance patterns or site of infection. Findings from the diSArm study, including the favorable safety and tolerability profile of AP-SA02, will inform the design of a larger definitive efficacy study to demonstrate superiority of AP-SA02 in treating complicated S. aureus bacteremia, and will form the basis for an End of Phase 2 meeting with the FDA which the Company intends to hold later this year. Importantly, Armata's planned superiority pivotal trial design will have the potential to change standard of care for a serious systemic pathogen that is responsible for significant morbidity and mortality in the United States. We are very grateful for the ongoing support of Innoviva and the U.S. Department of Defense for providing critical funding to enable us to continue to advance this promising program." "Together with previously announced promising trial results for our second clinical candidate, AP-PA02, a novel, inhaled multi-phage therapeutic for the treatment of chronic pulmonary Pseudomonas aeruginosa infections in people with cystic fibrosis and non-cystic fibrosis bronchiectasis, I continue to be very pleased with our progress. With two promising therapeutic candidates and a state-of-the-art manufacturing platform that can achieve the high purity necessary for clinical success, we are very well positioned to address areas of high unmet need while creating significant long-term value for our company," Dr. Birx concluded. Second Quarter 2025 Financial Results Grant and Award Revenue. The Company recognized grant and award revenue of $2.2 million for the three months ended June 30, 2025. This represents MTEC's share of the costs incurred for the Company's AP-SA02 program for the treatment of S. aureus bacteremia. The Company recognized no grant revenue for the three months ended June 30, 2024. Research and Development. Research and development expenses for the three months ended June 30, 2025 were approximately $6.4 million, compared to approximately $8.5 million for the comparable period in 2024. 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 June 30, 2025 were approximately $2.6 million, compared to approximately $3.4 million for the comparable period in 2024. Loss from Operations. Loss from operations for the three months ended June 30, 2025 was approximately $6.8 million, compared to a loss from operations of approximately $11.9 million for the comparable period in 2024. Cash and Cash Equivalents. As of June 30, 2025, Armata held approximately $4.3 million of unrestricted cash and cash equivalents, compared to $9.3 million as of December 31, 2024. As of August 12, 2025, approximately 36.2 million common shares were 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 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:https://www.prnewswire.com/news-releases/armata-pharmaceuticals-announces-second-quarter-2025-results-and-provides-corporate-update-302528113.html SOURCE Armata Pharmaceuticals, Inc.

LOS ANGELES, May 14, 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 first quarter ended March 31, 2025, and provided a corporate update. First Quarter 2025 and Recent Developments: Anticipating announcement of topline results from Phase 1b/2a diSArm study of intravenous AP-SA02 as a potential treatment for Staphylococcus aureus ("S. aureus") bacteremia in the first half of 2025. Received an additional $4.65 million of non-dilutive funding pursuant to a previously announced U.S. Department of Defense (the "DoD") award through the Medical Technology Enterprise Consortium ("MTEC") and managed by the Naval Medical Research Command ("NMRC") – Naval Advanced Medical Development ("NAMD") with funding from the Defense Health Agency and Joint Warfighter Medical Research Program. Supports Phase 2a study close-out activities, as well as the preparation and execution of an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (the "FDA"). Entered into a $10.0 million secured credit agreement with Innoviva Strategic Opportunities LLC, a wholly-owned subsidiary of Innoviva, Inc., Armata's principal shareholder (collectively, "Innoviva"). Amended existing credit and security agreements with Innoviva to extend the maturity date of each to March 12, 2026. Further advanced bacteriophage science through presentations and publications. Presented at the 7th Annual Bacteriophage Therapy Summit held on March 13th in Boston, Massachusetts. "During the first quarter of 2025, we completed our third Phase 2 study, specifically our Phase 1b/2a diSArm study of intravenous AP-SA02 as a potential treatment for complicated S. aureus bacteremia," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "Topline data is anticipated in the second quarter of 2025 to support a potential future pivotal efficacy trial. We recently announced additional award funding from the DoD through MTEC, which will be used to continue the support for the AP-SA02 product candidate and activities required for the end-of-Phase 2 meeting with the FDA to align on an efficient path toward Phase 3 and registration." "We continue to stay true to our mission of evaluating phage-based therapeutics in rigorously designed, randomized controlled clinical trials that can support potential regulatory approval, and I am very pleased with our progress to date," Dr. Birx concluded. First Quarter 2025 Financial Results Grant and Award Revenue. The Company recognized grant and award revenue of $0.5 million for the three months ended March 31, 2025, compared to $1.0 million in the comparable period in 2024. This 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 March 31, 2025 were approximately $5.4 million, compared to approximately $8.0 million for the comparable period in 2024. 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 March 31, 2025 were approximately $3.3 million, compared to approximately $3.2 million for the comparable period in 2024. The increase of $0.1 million is primarily related to an increase of $0.5 million in personnel expenses and an increase of $0.1 million in lease expenses, partially offset by a decrease of $0.5 million in consulting fees. Loss from Operations. Loss from operations for the three months ended March 31, 2025 was approximately $8.2 million, compared to a loss from operations of approximately $10.2 million for the comparable period in 2024. Net Loss. The net loss for the first quarter of 2025 was $6.5 million, or $0.18 loss per share on a basic and $0.20 loss per share on a diluted basis, as compared to a net loss of $25.0 million, or $0.69 loss per share on both a basic and diluted basis, for the comparable period in 2024. The net loss for the quarter ended March 31, 2025 included a non-cash gain from changes in fair value of the Company's convertible loan of $5.2 million, compared to a $13.0 million non-cash loss from changes in fair value of the Company's convertible loan for the quarter ended March 31, 2024. Cash and Cash Equivalents. As of March 31, 2025, Armata held approximately $11.7 million of unrestricted cash and cash equivalents, compared to $9.3 million as of December 31, 2024. As of May 8, 2025, approximately 36.2 million common shares were 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 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 [email protected] Investor Relations:Joyce AllaireLifeSci Advisors, [email protected]         View original content to download multimedia:https://www.prnewswire.com/news-releases/armata-pharmaceuticals-announces-first-quarter-2025-results-and-provides-corporate-update-302455622.html SOURCE Armata Pharmaceuticals, Inc.

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 [email protected] Investor Relations:Joyce AllaireLifeSci Advisors, [email protected]           View original content to download multimedia:https://www.prnewswire.com/news-releases/armata-pharmaceuticals-announces-fourth-quarter-and-full-year-2024-results-and-provides-corporate-update-302407557.html SOURCE Armata Pharmaceuticals, Inc.