Armata Pharmaceuticals Announces Third Quarter 2024 Results and Provides Corporate Update
Armata Pharmaceuticals announced Q3 2024 results and key developments. The company completed enrollment in two significant clinical trials: the Phase 2 'Tailwind' study of inhaled AP-PA02 for non-cystic fibrosis bronchiectasis, with topline data expected by year-end, and the Phase 1b/2a 'diSArm' study of intravenous AP-SA02 for S. aureus bacteremia, with results expected in Q1 2025. Financial highlights include grant revenue of $3.0M, R&D expenses of $9.5M, and a net loss of $5.5M ($0.15 per share). The company held $17.1M in cash as of September 30, 2024.
Armata Pharmaceuticals ha annunciato i risultati del terzo trimestre 2024 e sviluppi chiave. L'azienda ha completato il reclutamento in due importanti studi clinici: lo studio di Fase 2 'Tailwind' su AP-PA02 inalato per la bronchiectasia non relacionada alla fibrosi cistica, con i dati preliminari attesi entro la fine dell'anno, e lo studio di Fase 1b/2a 'diSArm' su AP-SA02 endovenoso per la batteriemia da S. aureus, con risultati attesi nel primo trimestre del 2025. I punti salienti finanziari includono ricavi da sovvenzioni di $3.0M, spese per R&S di $9.5M e una perdita netta di $5.5M ($0.15 per azione). L'azienda aveva $17.1M in contante al 30 settembre 2024.
Armata Pharmaceuticals anunció los resultados del tercer trimestre de 2024 y desarrollos clave. La compañía completó la inscripción en dos ensayos clínicos significativos: el estudio de Fase 2 'Tailwind' de AP-PA02 inhalado para la bronquiectasia no relacionada con fibrosis quística, con datos preliminares esperados para fin de año, y el estudio de Fase 1b/2a 'diSArm' de AP-SA02 intravenoso para la bacteriemia por S. aureus, con resultados esperados en el primer trimestre de 2025. Los aspectos financieros destacados incluyen ingresos por subvenciones de $3.0M, gastos en I+D de $9.5M, y una pérdida neta de $5.5M ($0.15 por acción). La compañía tenía $17.1M en efectivo al 30 de septiembre de 2024.
아르마타 제약은 2024년 3분기 결과와 주요 개발 사항을 발표했습니다. 이 회사는 두 개의 중요한 임상 시험에서 모집을 완료했습니다: 비낭성 섬유증 기관지 확장에서 흡입형 AP-PA02에 대한 2상 'Tailwind' 연구로, 연말까지 주요 데이터가 예상되며, S. aureus 박테리아혈증에 대한 정맥주사 AP-SA02에 대한 1b/2a 'diSArm' 연구로 2025년 1분기에 결과가 예상됩니다. 재무 하이라이트로는 300만 달러의 보조금 수익, 950만 달러의 연구개발비, 그리고 550만 달러의 순손실(주당 0.15달러)이 포함됩니다. 2024년 9월 30일 기준으로 회사의 현금 잔고는 1710만 달러였습니다.
Armata Pharmaceuticals a annoncé les résultats du troisième trimestre 2024 ainsi que des développements clés. La société a terminé l'inscription dans deux études cliniques majeures : l'étude de Phase 2 'Tailwind' sur l'AP-PA02 inhalé pour la bronchiectasie non liée à la fibrose kystique, avec des données principales attendues d'ici la fin de l'année, et l'étude de Phase 1b/2a 'diSArm' sur l'AP-SA02 intraveineux pour la bactériémie à S. aureus, avec des résultats attendus au premier trimestre 2025. Les points forts financiers incluent des revenus de subventions de 3,0 millions de dollars, des dépenses de R&D de 9,5 millions de dollars, et une perte nette de 5,5 millions de dollars (0,15 dollar par action). La société détenait 17,1 millions de dollars en liquidités au 30 septembre 2024.
Armata Pharmaceuticals hat die Ergebnisse für das dritte Quartal 2024 und wichtige Entwicklungen bekannt gegeben. Das Unternehmen hat die Einschreibung in zwei bedeutende klinische Studien abgeschlossen: die Phase-2-Studie 'Tailwind' zu inhalativem AP-PA02 bei nicht zystischer Fibrose Bronchiektasie, mit den wichtigsten Daten, die bis zum Jahresende erwartet werden, und die Phase-1b/2a-Studie 'diSArm' zu intravenösem AP-SA02 bei S. aureus-Bakteriämie, deren Ergebnisse im ersten Quartal 2025 erwartet werden. Die finanziellen Highlights umfassen Zuschusseinnahmen von 3,0 Millionen USD, F&E-Ausgaben von 9,5 Millionen USD und einen Nettoverlust von 5,5 Millionen USD (0,15 USD pro Aktie). Das Unternehmen verfügte zum 30. September 2024 über 17,1 Millionen USD in bar.
- Grant revenue increased to $3.0M from $1.2M in Q3 2023
- Received additional $5.25M in non-dilutive funding from Department of Defense
- Cash position improved to $17.1M from $13.5M at end of 2023
- Reduced net loss to $5.5M from $31.2M in Q3 2023
- R&D expenses increased to $9.5M from $8.0M in Q3 2023
- Operating loss of $9.8M in Q3 2024
- Extended debt maturity, potentially indicating cash flow concerns
Insights
The Q3 results reveal a mixed financial picture for Armata Pharmaceuticals. While grant revenue increased significantly to
The cash position of
Two significant clinical milestones are approaching with the completion of enrollment in both the Tailwind Phase 2 study for bronchiectasis and the diSArm Phase 1b/2a bacteremia trial. The successful dose escalation to 2E11 PFU in the bacteremia trial demonstrates promising safety data for intravenous phage therapy. The company's strategic positioning in both pulmonary and systemic applications of phage therapy, along with plans for pivotal trials in 2025, represents a comprehensive approach to addressing antibiotic-resistant infections.
The upcoming data readouts by year-end 2024 and Q1 2025 will be critical in validating the company's phage platform technology and informing the design of planned Phase 3 trials.
Third Quarter 2024 and Recent Developments:
- Completed enrollment of the Phase 2 study ("Tailwind") of inhaled AP-PA02 in patients with non-cystic fibrosis bronchiectasis ("NCFB") and chronic pulmonary Pseudomonas aeruginosa ("P. aeruginosa") infection.
- Topline data expected by year-end.
- Working towards initiating a pivotal bronchiectasis trial in 2025 for chronic pulmonary P. aeruginosa infection.
- Completed enrollment of Phase 1b/2a study ("diSArm") of intravenous AP-SA02 in patients with Staphylococcus aureus ("S. aureus") bacteremia.
- Topline data expected in the first quarter of 2025.
- Moving towards initiating a pivotal S. aureus bacteremia trial in 2025.
- Received
of additional non-dilutive funding to support the diSArm study pursuant to a previously announced Department of Defense grant, 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.$5.25 million - Further advanced bacteriophage science through presentations and publications:
- Announced publication in Communications Biology describing the structure of a Pseudomonas phage, representative of a family present in the clincial candidate cocktail AP-PA02.
- Delivered a poster presentation at the 2024 Military Health System Research Symposium (MHSRS), held August 26-29, in
Kissimmee, Florida . - Delivered an oral presentation on advancing bacteriophage therapy at Viruses of Microbes 2024, held July 15-19, in Cairns,
Australia .
- Appointed life sciences accounting and finance veteran David House as Senior Vice President, Finance.
- Amended convertible debt and 2023 credit agreement to extend the maturity dates from January 10, 2025 to January 10, 2026.
"During the third quarter, we completed enrollment of our Phase 2 Tailwind study of inhaled AP-PA02 in NCFB patients with chronic P. aeruginosa infection, and remain on-track to report topline data from this study by the end of this year," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "This will mark our second Phase 2 data readout for inhaled AP-PA02, following prior successful evaluation in patients with cystic fibrosis in the Phase 1b/2a SWARM-P.a. clinical trial last year. We plan to meet with the
"Additionally, we have completed enrollment of our Phase 1b/2a diSArm study evaluating intravenous AP-SA02 as a potential treatment for S. aureus bacteremia. The high purity of Armata's intravenously-administered phage drug products enabled dose escalation to 2E11 PFU every 24 hours for five days, which was well-tolerated. We look forward to topline data in the first quarter of 2025 that should inform the optimal dose of AP-SA02 to be evaluated in a larger definitive efficacy study that we are planning to initiate in 2025."
"With two Phase 2 data readouts expected near-term, we believe we continue to add to the body of evidence demonstrating the potential of phage therapy, either as an alternative to or in combination with current standard of care antibiotics, to combat antibiotic-resistant and difficult-to-treat bacterial infections. I am delighted with our progress to date, and look forward to potential major value inflection points in 2025 and beyond," Dr. Birx concluded.
Third Quarter 2024 Financial Results
Grant Revenue. The Company recognized grant revenue of
Research and Development. Research and development expenses for the three months ended September 30, 2024 were approximately
General and Administrative. General and administrative expenses for the three months ended September 30, 2024 were approximately
Loss from Operations. Loss from operations for the three months ended September 30, 2024 was approximately
Net Loss. The net loss for the third quarter of 2024 was
Cash and Equivalents. As of September 30, 2024, Armata held approximately
As of November 13, 2024, 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 pathogen-specific bacteriophage therapeutics for the treatment of antibiotic-resistant and difficult-to-treat bacterial infections using its proprietary bacteriophage-based technology. Armata is developing and advancing a broad pipeline of natural and synthetic phage candidates, including clinical candidates for Pseudomonas aeruginosa, Staphylococcus aureus, and other pathogens. Armata is committed to advancing phage therapy with drug development expertise that spans bench to clinic including in-house phage specific cGMP manufacturing.
Forward Looking Statements
This communication contains "forward-looking" statements as defined by the Private Securities Litigation Reform Act of 1995. These statements relate to future events, results or to Armata's future financial performance and involve known and unknown risks, uncertainties and other factors which may cause Armata's actual results, performance or events to be materially different from any future results, performance or events expressed or implied by the forward-looking statements. In some cases, you can identify these statements by terms such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" or the negative of those terms, and similar expressions. These forward-looking statements reflect management's beliefs and views with respect to future events and are based on estimates and assumptions as of the date of this communication and are subject to risks and uncertainties including risks related to Armata's development of bacteriophage-based therapies; ability to staff and maintain its production facilities under fully compliant current Good Manufacturing Practices; ability to meet anticipated milestones in the development and testing of the relevant product; ability to be a leader in the development of phage-based therapeutics; ability to achieve its vision, including improvements through engineering and success of clinical trials; ability to successfully complete preclinical and clinical development of, and obtain regulatory approval of its product candidates and commercialize any approved products on its expected timeframes or at all; and Armata's estimates regarding anticipated operating losses, capital requirements and needs for additional funds. Additional risks and uncertainties relating to Armata and its business can be found under the caption "Risk Factors" and elsewhere in Armata's filings and reports with the SEC, including in Armata's Annual Report on Form 10-K, filed with the SEC on March 21, 2024, and in its subsequent filings with the SEC.
Armata expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Armata's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
Media Contacts:
At Armata:
Pierre Kyme
ir@armatapharma.com
310-665-2928
Investor Relations:
Joyce Allaire
LifeSci Advisors, LLC
jallaire@lifesciadvisors.com
212-915-2569
Armata Pharmaceuticals, Inc. Condensed Consolidated Balance Sheets (in thousands) (unaudited) | ||||||
September 30, 2024 | December 31, 2023 | |||||
Assets | ||||||
Current assets | ||||||
Cash and cash equivalents | $ | 17,141 | $ | 13,523 | ||
Prepaid expenses and other current assets | 3,029 | 2,265 | ||||
Other receivables | 2,219 | 3,363 | ||||
Total current assets | 22,389 | 19,151 | ||||
Property and equipment, net | 13,616 | 12,559 | ||||
Operating lease right-of-use asset | 42,251 | 44,717 | ||||
Intangible assets, net | 13,746 | 13,746 | ||||
Other long term assets | 6,235 | 8,190 | ||||
Total assets | $ | 98,237 | $ | 98,363 | ||
Liabilities and stockholders' deficit | ||||||
Accounts payable, accrued and other current liabilities | 10,801 | 16,461 | ||||
Convertible debt, current | 41,357 | — | ||||
Term debt, current | 66,046 | — | ||||
Total current liabilities | $ | 118,204 | $ | 16,461 | ||
Convertible debt, non-current | — | 58,633 | ||||
Term debt, non-current | — | 23,674 | ||||
Operating lease liabilities, net of current portion | 27,929 | 28,583 | ||||
Deferred tax liability | 3,077 | 3,077 | ||||
Total liabilities | 149,210 | 130,428 | ||||
Stockholders' deficit | (50,973) | (32,065) | ||||
Total liabilities and stockholders' deficit | $ | 98,237 | $ | 98,363 |
Armata Pharmaceuticals, Inc. Condensed Consolidated Statements of Operations (in thousands, except share and per share data) (unaudited) | ||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||
September 30, | September 30, | |||||||||||
2024 | 2023 | 2024 | 2023 | |||||||||
Grant revenue | $ | 2,973 | $ | 1,225 | $ | 3,939 | $ | 3,001 | ||||
Operating expenses: | ||||||||||||
Research and development | 9,485 | 7,978 | 25,975 | 25,842 | ||||||||
General and administrative | 3,244 | 3,583 | 9,861 | 8,470 | ||||||||
Total operating expenses | 12,729 | 11,561 | 35,836 | 34,312 | ||||||||
Operating loss | (9,756) | (10,336) | (31,897) | (31,311) | ||||||||
Interest income | 294 | 47 | 567 | 111 | ||||||||
Interest expense | (2,923) | (1,176) | (7,462) | (1,176) | ||||||||
Change in fair value of convertible debt | 6,904 | (15,833) | 17,276 | (12,959) | ||||||||
Loss on convertible debt extinguishment | — | (3,863) | — | (3,863) | ||||||||
Net loss | $ | (5,481) | $ | (31,161) | $ | (21,516) | $ | (49,198) | ||||
Per share information: | ||||||||||||
Net loss per share, basic and diluted | $ | (0.15) | $ | (0.86) | $ | (0.60) | $ | (1.36) | ||||
Weighted average shares outstanding, basic and diluted | 36,180,124 | 36,086,990 | 36,153,388 | 36,067,025 |
Armata Pharmaceuticals, Inc. Condensed Consolidated Statements of Cash Flows (in thousands) (unaudited) | ||||||
Nine Months Ended September 30, | ||||||
2024 | 2023 | |||||
Operating activities: | ||||||
Net loss | $ | (21,516) | $ | (49,198) | ||
Adjustments required to reconcile net loss to net cash used in operating activities: | ||||||
Depreciation and amortization expense | 945 | 679 | ||||
Stock-based compensation expense | 2,539 | 745 | ||||
Change in fair value of convertible debt | (17,276) | 12,959 | ||||
Non-cash interest expense | 7,483 | 1,176 | ||||
Loss on convertible debt extinguishment | — | 3,863 | ||||
Change in right-of-use asset | 1,489 | 662 | ||||
Changes in operating assets and liabilities: | (3,288) | (10,203) | ||||
Net cash used in operating activities | (29,624) | (39,317) | ||||
Investing activities: | ||||||
Purchases of property and equipment | (1,956) | (5,744) | ||||
Net cash used in investing activities | (1,956) | (5,744) | ||||
Financing activities: | ||||||
Proceeds from issuance of convertible debt, net of issuance costs | — | 29,101 | ||||
Proceeds from issuance of term debt, net of issuance costs | 34,889 | 24,925 | ||||
Payments for taxes related to net share settlement of equity awards | (61) | — | ||||
Proceeds from exercise of stock options | 130 | 5 | ||||
Net cash provided by financing activities | 34,958 | 54,031 | ||||
Net increase in cash, cash equivalents and restricted cash | 3,378 | 8,970 | ||||
Cash, cash equivalents and restricted cash, beginning of period | 19,243 | 20,812 | ||||
Cash, cash equivalents and restricted cash, end of period | $ | 22,621 | $ | 29,782 | ||
Nine Months Ended September 30, | ||||||
2024 | 2023 | |||||
Cash and cash equivalents | $ | 17,141 | $ | 23,958 | ||
Restricted cash | 5,480 | 5,824 | ||||
Cash, cash equivalents and restricted cash, end of period | $ | 22,621 | $ | 29,782 |
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SOURCE Armata Pharmaceuticals, Inc.
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