Armata Pharmaceuticals Announces Second Quarter 2024 Results and Provides Corporate Update
Armata Pharmaceuticals (NYSE American: ARMP) announced its Q2 2024 results and provided a corporate update. Key developments include:
1. Completed enrollment in Phase 2 Tailwind study of AP-PA02 for Non-Cystic Fibrosis Bronchiectasis, with topline data expected in H2 2024.
2. Received $5.25 million in non-dilutive funding from the U.S. Department of Defense for the Phase 2a diSArm study of AP-SA02 for S. aureus bacteremia.
3. Completed build-out of advanced biologics manufacturing facility with five cGMP clean rooms.
Financial highlights: No grant revenue in Q2 2024 vs $1.0 million in Q2 2023. R&D expenses increased to $8.5 million. Loss from operations was $11.9 million. Cash and equivalents stood at $26.4 million as of June 30, 2024.
Armata Pharmaceuticals (NYSE American: ARMP) ha annunciato i risultati del secondo trimestre del 2024 e ha fornito un aggiornamento aziendale. Sviluppi chiave includono:
1. Completamento dell'arruolamento nello studio di Fase 2 Tailwind di AP-PA02 per la bronchiectasia non da fibrosi cistica, con i dati preliminari attesi nel secondo semestre del 2024.
2. Ricevuti 5,25 milioni di dollari in finanziamenti non diluitivi dal Dipartimento della Difesa degli Stati Uniti per lo studio di Fase 2a di diSArm su AP-SA02 per la batteremia da S. aureus.
3. Completamento della costruzione di un impianto avanzato di produzione di biologici con cinque camere bianche cGMP.
In evidenza finanziaria: Nessun ricavo da sovvenzioni nel secondo trimestre del 2024 contro 1,0 milione di dollari nel secondo trimestre del 2023. Le spese per R&S sono aumentate a 8,5 milioni di dollari. La perdita da operazioni è stata di 11,9 milioni di dollari. Liquidità e equivalenti si attestavano a 26,4 milioni di dollari al 30 giugno 2024.
Armata Pharmaceuticals (NYSE American: ARMP) anunció sus resultados del segundo trimestre de 2024 y proporcionó una actualización corporativa. Los desarrollos clave incluyen:
1. Se completó la inscripción en el estudio de Fase 2 Tailwind de AP-PA02 para la bronquiectasia no fibrocística, con los datos preliminares esperados para el segundo semestre de 2024.
2. Se recibió $5.25 millones en financiación no dilutiva del Departamento de Defensa de EE. UU. para el estudio de fase 2a diSArm de AP-SA02 para la bacteriemia por S. aureus.
3. Se completó la construcción de una instalación avanzada de fabricación de biológicos con cinco salas limpias cGMP.
Aspectos destacados financieros: No se registraron ingresos por subvenciones en el segundo trimestre de 2024 frente a $1.0 millón en el segundo trimestre de 2023. Los gastos de I+D aumentaron a $8.5 millones. La pérdida de operaciones fue de $11.9 millones. El efectivo y equivalentes se situaron en $26.4 millones al 30 de junio de 2024.
Armata Pharmaceuticals (NYSE American: ARMP)는 2024년 2분기 결과를 발표하고 기업 업데이트를 제공했습니다. 주요 개발 사항은 다음과 같습니다:
1. 비낭포성 섬유증 기관지 확장증에 대한 AP-PA02의 2상 Tailwind 연구에 대한 등록을 완료하였으며, 상반기 데이터는 2024년 하반기에 예상됩니다.
2. S. aureus 혈전증에 대한 AP-SA02의 2a diSArm 연구를 위해 미국 국방부에서 비희석 자금으로 525만 달러를 받았습니다.
3. 5개의 cGMP 클린룸을 갖춘 고급 생물학 제조 시설의 건설을 완료했습니다.
재무 하이라이트: 2024년 2분기에는 보조금 수익 없이 2023년 2분기의 100만 달러와 대비됩니다. 연구 및 개발 비용은 850만 달러로 증가했습니다. 운영 손실은 1190만 달러였습니다. 2024년 6월 30일 기준으로 현금 및 등가물은 2640만 달러입니다.
Armata Pharmaceuticals (NYSE American: ARMP) a annoncé ses résultats du deuxième trimestre 2024 et a fourni une mise à jour d'entreprise. Développements clés incluent:
1. Achèvement de l'inscription dans l'étude de phase 2 Tailwind d'AP-PA02 pour la bronchiectasie non fibrose, avec des données préliminaires attendues au second semestre 2024.
2. Réception de 5,25 millions de dollars de financement non dilutif du Département de la Défense des États-Unis pour l'étude diSArm de phase 2a d'AP-SA02 pour la bactériémie à S. aureus.
3. Achèvement de la construction d'une installation avancée de fabrication de biologiques avec cinq salles blanches cGMP.
Points financiers saillants: Aucun revenu de subvention au 2e trimestre 2024 contre 1,0 million de dollars au 2e trimestre 2023. Les dépenses de R&D ont augmenté à 8,5 millions de dollars. La perte d'exploitation s'élevait à 11,9 millions de dollars. Les liquidités et équivalents s'élevaient à 26,4 millions de dollars au 30 juin 2024.
Armata Pharmaceuticals (NYSE American: ARMP) hat die Ergebnisse des zweiten Quartals 2024 bekannt gegeben und ein Unternehmensupdate bereitgestellt. Wesentliche Entwicklungen umfassen:
1. Der Abschluss der Rekrutierung für die Phase-2-Studie Tailwind zu AP-PA02 für nicht zystische Fibrose-Bronchiektasie, mit den ersten Ergebnissen, die für das 2. Halbjahr 2024 erwartet werden.
2. Erhalt von 5,25 Millionen Dollar an nicht verwässernder Finanzierung vom US-Verteidigungsministerium für die Phase-2a diSArm-Studie zu AP-SA02 für S. aureus-Bakteriämie.
3. Fertigstellung des Aufbaus einer modernen Biologikanlage mit fünf cGMP-Reinräumen.
Finanzielle Highlights: Keine Zuschusseinnahmen im 2. Quartal 2024 im Vergleich zu 1,0 Millionen Dollar im 2. Quartal 2023. Die F&E-Ausgaben stiegen auf 8,5 Millionen Dollar. Der Betriebsverlust betrug 11,9 Millionen Dollar. Zahlungsmittel und Zahlungsmitteläquivalente beliefen sich zum 30. Juni 2024 auf 26,4 Millionen Dollar.
- Completed enrollment in Phase 2 Tailwind study of AP-PA02, with topline data expected in H2 2024
- Received $5.25 million in non-dilutive funding from U.S. Department of Defense
- Completed build-out of advanced biologics manufacturing facility with five cGMP clean rooms
- Cash and equivalents increased to $26.4 million as of June 30, 2024, up from $13.5 million at end of 2023
- No grant revenue recognized in Q2 2024 compared to $1.0 million in Q2 2023
- Increased loss from operations to $11.9 million in Q2 2024 from $9.6 million in Q2 2023
- R&D expenses increased to $8.5 million in Q2 2024 from $8.3 million in Q2 2023
- General and administrative expenses increased to $3.4 million in Q2 2024 from $2.4 million in Q2 2023
Insights
Armata Pharmaceuticals' Q2 2024 update reveals significant progress in their phage therapy pipeline. The completion of enrollment in the Tailwind Phase 2 study for AP-PA02 in NCFB patients is a important milestone. With topline data expected in H2 2024, this could be a pivotal moment for the company's lead candidate.
The additional
The completion of their cGMP manufacturing facility is a strategic asset, potentially accelerating clinical trials and future commercialization efforts. However, the
Armata's financial position shows a mixed picture. The increase in cash and equivalents from
R&D expenses remained relatively stable at
Armata's focus on bacteriophage therapeutics for antibiotic-resistant infections addresses a critical unmet medical need. The completion of the Tailwind study for AP-PA02 in NCFB patients is significant, as chronic P. aeruginosa infections are notoriously difficult to treat.
The advancement of the diSArm study for AP-SA02 in S. aureus bacteremia is equally promising, targeting another severe, often drug-resistant infection. The company's commitment to rigorous, randomized clinical studies is commendable and essential for establishing phage therapy as a viable alternative to traditional antibiotics.
Armata's investment in a state-of-the-art cGMP facility demonstrates foresight, potentially accelerating the transition from clinical trials to commercial production if their candidates prove successful.
Second Quarter 2024 and Recent Developments:
- Announced completion of enrollment in its Tailwind Phase 2 clinical study of inhaled AP-PA02 in patients with Non-Cystic Fibrosis Bronchiectasis (NCFB) and chronic pulmonary Pseudomonas aeruginosa (P. aeruginosa) infection. The last patient final follow-up visit occurred on August 7. Armata anticipates topline data from the Tailwind study in the second half of 2024.
- Received
of additional non-dilutive funding from the$5.25 million U.S. Department of Defense pursuant to a previously-announced grant. The award is partially supporting advancement of the Phase 2a portion of the diSArm study of intravenous AP-SA02 as a potential treatment for Staphylococcus aureus (S. aureus) bacteremia. - Further advanced bacteriophage science through presentations and publications:
- Delivered a presentation on advancing bacteriophage therapy at Viruses of Microbes 2024, which was held July 15-19, 2024, in Cairns,
Australia .
- Delivered a presentation on advancing bacteriophage therapy at Viruses of Microbes 2024, which was held July 15-19, 2024, in Cairns,
- Completed the build-out of its advanced biologics manufacturing facility with five current good manufacturing practice ("cGMP") clean rooms, including a state-of-the-art automated fill and finish suite.
"During the second quarter and subsequent period, we made meaningful progress across both of our clinical programs, keeping us on track to potentially initiate pivotal studies next year," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "Regarding AP-PA02, which we are developing as an inhaled treatment for chronic P. aeruginosa lung infections, I am pleased to report that we recently completed enrollment and the last patient visit in our Phase 2 Tailwind study in subjects with NCFB, and we plan to announce topline data later this year."
"For AP-SA02, we continued to advance our Phase 2a diSArm study of intravenous AP-SA02 as a potential treatment for S. aureus bacteremia. We are grateful to the Department of Defense for its ongoing financial support, which provides us with critical non-dilutive funding. We look forward to completing the diSArm study later this year and identifying the optimal dose of AP-SA02 to be tested in a larger definitive study."
"Also, during the second quarter, we completed the build-out of our state-of-the-art cGMP manufacturing facility, giving us the ability to support our late-stage clinical trials, potential partnerships, and potential commercial production."
"Our mission has long been the execution of rigorously designed, randomized clinical studies that demonstrate the safety and efficacy of our multi-phage candidates to support eventual registration, and I am very pleased with our sustained progress during the second quarter and through the first half of the year," Dr. Birx concluded.
Second Quarter 2024 Financial Results
Grant Revenue. The Company recognized no grant revenue for the three months ended June 30, 2024. The Company recognized approximately
Research and Development. Research and development expenses for the three months ended June 30, 2024 were approximately
General and Administrative. General and administrative expenses for the three months ended June 30, 2024 were approximately
Loss from Operations. Loss from operations for the three months ended June 30, 2024 was
Cash and Equivalents. As of June 30, 2024, Armata held approximately
As of August 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) | |||||||
June 30, 2024 | December 31, 2023 | ||||||
Assets | |||||||
Current assets | |||||||
Cash and cash equivalents | $ | 26,405 | $ | 13,523 | |||
Prepaid expenses and other current assets | 3,256 | 2,265 | |||||
Other receivables | 1,242 | 3,363 | |||||
Total current assets | 30,903 | 19,151 | |||||
Property and equipment, net | 13,474 | 12,559 | |||||
Operating lease right-of-use asset | 43,671 | 44,717 | |||||
Intangible assets, net | 13,746 | 13,746 | |||||
Other long term assets | 6,519 | 8,190 | |||||
Total assets | $ | 108,313 | $ | 98,363 | |||
Liabilities and stockholders' deficit | |||||||
Total current liabilities | $ | 123,181 | $ | 16,461 | |||
Long-term debt | — | 82,307 | |||||
Operating lease liabilities, net of current portion | 28,156 | 28,583 | |||||
Deferred tax liability | 3,077 | 3,077 | |||||
Total liabilities | 154,414 | 130,428 | |||||
Stockholders' deficit | (46,101) | (32,065) | |||||
Total liabilities and stockholders' deficit | $ | 108,313 | $ | 98,363 |
Armata Pharmaceuticals, Inc. Condensed Consolidated Statements of Operations (in thousands, except share and per share data) (unaudited) | |||||||||||||
Three Months Ended | Six Months Ended | ||||||||||||
June 30, | June 30, | ||||||||||||
2024 | 2023 | 2024 | 2023 | ||||||||||
Grant revenue | $ | — | $ | 980 | $ | 966 | $ | 1,776 | |||||
Operating expenses: | |||||||||||||
Research and development | 8,475 | 8,259 | 16,491 | 17,863 | |||||||||
General and administrative | 3,439 | 2,350 | 6,617 | 4,888 | |||||||||
Total operating expenses | 11,914 | 10,609 | 23,108 | 22,751 | |||||||||
Operating loss | (11,914) | (9,629) | (22,142) | (20,975) | |||||||||
Interest income | 221 | 46 | 273 | 64 | |||||||||
Interest expense | (2,718) | — | (4,538) | — | |||||||||
Change in fair value of convertible debt | 23,397 | 6,036 | 10,372 | 2,874 | |||||||||
Net income (loss) | $ | 8,986 | $ | (3,547) | $ | (16,035) | $ | (18,037) | |||||
Per share information: | |||||||||||||
Net income (loss) per share, basic | $ | 0.25 | $ | (0.10) | $ | (0.44) | $ | (0.50) | |||||
Weighted average shares outstanding, basic | 36,154,521 | 36,068,130 | 36,139,873 | 36,056,649 | |||||||||
Net loss per share, diluted | $ | (0.25) | $ | (0.17) | $ | (0.45) | $ | (0.50) | |||||
Weighted average shares outstanding, diluted | 58,246,626 | 56,544,698 | 58,231,978 | 36,056,649 |
Armata Pharmaceuticals, Inc. Condensed Consolidated Statements of Cash Flows (in thousands) (unaudited) | |||||||
Six Months Ended June 30, | |||||||
2024 | 2023 | ||||||
Operating activities: | |||||||
Net loss | $ | (16,035) | $ | (18,037) | |||
Adjustments required to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation and amortization expense | 632 | 458 | |||||
Stock-based compensation expense | 1,869 | 1,118 | |||||
Change in fair value of convertible debt | (10,372) | (2,874) | |||||
Non-cash interest expense | 4,538 | — | |||||
Change in right-of-use asset | 960 | — | |||||
Changes in operating assets and liabilities: | (2,353) | (10,295) | |||||
Net cash used in operating activities | (20,761) | (29,630) | |||||
Investing activities: | |||||||
Purchases of property and equipment | (1,616) | (2,232) | |||||
Net cash used in investing activities | (1,616) | (2,232) | |||||
Financing activities: | |||||||
Proceeds from issuance of convertible debt, net of issuance costs | — | 29,226 | |||||
Proceeds from issuance of long-term debt, net of issuance costs | 34,889 | — | |||||
Proceeds from exercise of stock options | 130 | — | |||||
Net cash provided by financing activities | 35,019 | 29,226 | |||||
Net increase (decrease) in cash, cash equivalents and restricted cash | 12,642 | (2,636) | |||||
Cash, cash equivalents and restricted cash, beginning of period | 19,243 | 20,812 | |||||
Cash, cash equivalents and restricted cash, end of period | $ | 31,885 | $ | 18,176 | |||
Six Months Ended June 30, | |||||||
2024 | 2023 | ||||||
Cash and cash equivalents | $ | 26,405 | $ | 12,456 | |||
Restricted cash | 5,480 | 5,720 | |||||
Cash and restricted cash | $ | 31,885 | $ | 18,176 |
View original content to download multimedia:https://www.prnewswire.com/news-releases/armata-pharmaceuticals-announces-second-quarter-2024-results-and-provides-corporate-update-302219948.html
SOURCE Armata Pharmaceuticals, Inc.
FAQ
What were Armata Pharmaceuticals' (ARMP) key developments in Q2 2024?
When does Armata Pharmaceuticals (ARMP) expect topline data from the Tailwind study?
What was Armata Pharmaceuticals' (ARMP) cash position as of June 30, 2024?