"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.
"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
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 ("
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 inLos 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.- Intended to facilitate the development and expedite 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 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.
- 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.- The Agreed iPSP outlines a proposed pediatric development program targeting patients up to 17 years of age with complicated S. aureus bacteremia ("
SAB "), the same indication Armata is pursuing in adults, with pediatric studies deferred until safety and efficacy data are generated in adults in the planned Phase 3 program. - This strategy establishes a pathway for potential future expansion of AP-SA02 into the pediatric population while prioritizing patient safety and efficient clinical development.
- The Agreed iPSP outlines a proposed pediatric development program targeting patients up to 17 years of age with complicated S. aureus bacteremia ("
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 sinceAugust 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
Research and Development. Research and development expenses for the three months ended
General and Administrative. General and administrative expenses for the three months ended
Loss from Operations. Loss from operations for the three months ended
Other Income (Expense). Other income, net, for the three months ended
Net Income (Loss). The net income for the second quarter of 2026 was
Cash and Cash Equivalents. As of
As of
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
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 Kyme
ir@armatapharma.com
310-665-2928
Investor Relations:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com
212-915-2569
Condensed Consolidated Balance Sheets | |||||||
(in thousands) | |||||||
(unaudited) | |||||||
June 30, 2026 | December 31, 2025 | ||||||
Assets | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | 23,952 | $ | 8,688 | |||
Prepaid expenses and other current assets | 673 | 1,508 | |||||
Other receivables | 2,532 | 472 | |||||
Total current assets | 27,157 | 10,668 | |||||
Property and equipment, net | 11,230 | 12,194 | |||||
Operating lease right-of-use asset | 32,884 | 33,911 | |||||
Intangible assets, net | 13,746 | 13,746 | |||||
Other long-term assets | 4,933 | 6,363 | |||||
Total assets | $ | 89,950 | $ | 76,882 | |||
Liabilities and stockholders' deficit | |||||||
Accounts payable, accrued and other current liabilities | $ | 8,715 | $ | 8,947 | |||
Convertible Loan, current | 163,904 | — | |||||
Term debt, current | 77,580 | — | |||||
Total current liabilities | 250,199 | 8,947 | |||||
Convertible Loan, non-current | — | 153,860 | |||||
Term debt, non-current | 42,024 | 103,061 | |||||
Operating lease liabilities, net of current portion | 25,823 | 26,533 | |||||
Deferred tax liability | 3,077 | 3,077 | |||||
Total liabilities | 321,123 | 295,478 | |||||
Total stockholders' deficit | (231,173) | (218,596) | |||||
Total liabilities and stockholders' deficit | $ | 89,950 | $ | 76,882 | |||
Condensed Consolidated Statements of Operations | |||||||||||
(in thousands, except share and per share data) | |||||||||||
(unaudited) | |||||||||||
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||
2026 | 2025 | 2026 | 2025 | ||||||||
Grant and award revenue | $ | 2,510 | $ | 2,169 | $ | 3,299 | $ | 2,660 | |||
Operating expenses | |||||||||||
Research and development | 7,586 | 6,394 | 13,697 | 11,823 | |||||||
General and administrative | 5,236 | 2,619 | 8,699 | 5,872 | |||||||
Total operating expenses | 12,822 | 9,013 | 22,396 | 17,695 | |||||||
Operating loss | (10,312) | (6,844) | (19,097) | (15,035) | |||||||
Other income (expense) | |||||||||||
Interest income | 69 | 108 | 129 | 167 | |||||||
Interest expense | (6,634) | (3,808) | (12,193) | (7,410) | |||||||
Change in fair value of the Convertible Loan | 91,018 | (5,751) | (10,044) | (548) | |||||||
Total other income (expense), net | 84,453 | (9,451) | (22,108) | (7,791) | |||||||
Net income (loss) | $ | 74,141 | $ | (16,295) | $ | (41,205) | $ | (22,826) | |||
Per share information: | |||||||||||
Net income (loss) per share, basic | $ | 2.02 | $ | (0.45) | $ | (1.12) | $ | (0.63) | |||
Weighted average shares outstanding, basic | 36,747,840 | 36,193,479 | 36,639,663 | 36,189,165 | |||||||
Net loss per share, diluted | $ | (0.27) | $ | (0.45) | $ | (1.12) | $ | (0.63) | |||
Weighted average shares outstanding, diluted | 62,041,700 | 36,193,479 | 36,639,663 | 36,189,165 | |||||||
Condensed Consolidated Statements of Cash Flows | ||||||
(in thousands) | ||||||
(unaudited) | ||||||
Six Months Ended June 30, | ||||||
2026 | 2025 | |||||
Operating activities: | ||||||
Net loss | $ | (41,205) | $ | (22,826) | ||
Adjustments required to reconcile net loss to net cash used in operating activities: | ||||||
Depreciation expense | 1,048 | 743 | ||||
Stock-based compensation expense | 4,466 | 1,356 | ||||
Change in fair value of the Convertible Loan | 10,044 | 548 | ||||
Non-cash interest expense | 12,183 | 7,398 | ||||
Change in right-of-use asset | 1,027 | 1,183 | ||||
Changes in operating assets and liabilities: | (2,011) | (3,193) | ||||
Net cash used in operating activities | (14,448) | (14,791) | ||||
Investing activities: | ||||||
Purchases of property and equipment | (80) | (248) | ||||
Net cash used in investing activities | (80) | (248) | ||||
Financing activities: | ||||||
Proceeds from issuance of term debt, net of issuance costs | 25,000 | 10,000 | ||||
Proceeds from issuance of common stock under ATM, net | 2,373 | — | ||||
Payments for taxes related to net share settlement of equity awards | (63) | (14) | ||||
Proceeds from exercise of stock options | 1,212 | — | ||||
Net cash provided by financing activities | 28,522 | 9,986 | ||||
Net change in cash, cash equivalents and restricted cash | 13,994 | (5,053) | ||||
Cash, cash equivalents and restricted cash, beginning of period | 14,078 | 14,771 | ||||
Cash, cash equivalents and restricted cash, end of period | $ | 28,072 | $ | 9,718 | ||
Reconciliation of cash, cash equivalents and restricted cash to the consolidated balance sheets: | Six Months Ended June 30, | |||||
2026 | 2025 | |||||
Cash and cash equivalents | $ | 23,952 | $ | 4,328 | ||
Restricted cash | 4,120 | 5,390 | ||||
Cash, cash equivalents and restricted cash | $ | 28,072 | $ | 9,718 | ||
i Department of War (DoW) award received through the | ||||
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