Armata Pharmaceuticals Announces Fourth Quarter and Full-Year 2023 Results and Provides Corporate Update
- Armata Pharmaceuticals reported financial results for Q4 and full-year 2023.
- Positive data from clinical trials of AP-SA02 and AP-PA02 were highlighted.
- Promising biologic impact and phage distribution were observed in patient populations.
- The company emphasized its commitment to high-purity phage development and efficient randomized studies.
- CEO Dr. Deborah Birx expressed optimism about the company's progress and future potential.
- None.
Insights
The financial results and corporate updates from Armata Pharmaceuticals are of significant interest to current and potential investors, as they provide insights into the company's operational progress and strategic direction. The advancement of clinical trials, particularly the Phase 2a diSArm study and the Phase 2 Tailwind study, is an indication of the company's commitment to addressing antibiotic-resistant infections, a pressing medical issue with substantial market demand. The financial support from the Cystic Fibrosis Foundation and the U.S. Department of Defense not only validates the potential of Armata's phage therapeutics but also helps mitigate financial risks associated with the costly drug development process.
Furthermore, the nearing completion of the advanced biologics manufacturing facility, which includes cGMP suites and an automated fill and finish suite, is pivotal for the transition from clinical trials to commercial production. This expansion suggests that Armata is preparing for the anticipated regulatory approval and market entry of its phage therapeutics. Investors should monitor the outcomes of the ongoing clinical trials, as positive results could significantly impact the company's valuation and stock performance, particularly if the therapeutics demonstrate a competitive edge in safety and efficacy over existing treatments.
The data presented by Armata Pharmaceuticals indicates a potentially groundbreaking approach in treating antibiotic-resistant infections with high-purity bacteriophage therapeutics. The ability to escalate doses due to phage purity and the observed similar biologic impact of phage therapy alone compared to phage plus antibiotics are promising signs. These findings could lead to a paradigm shift in the treatment of bacterial infections, especially given the specificity of phage therapy in preserving the normal microbiome and reducing opportunistic infections.
From a research perspective, the completion of the Phase 2 diSArm study within the year and the progression of the Phase 2 Tailwind study are critical milestones that could pave the way for Phase 3 trials and eventual FDA approval. The manufacturing advancements mentioned are equally crucial, as they will ensure the capacity to produce phage therapeutics at scale, which is a significant hurdle for biologics. The clinical and manufacturing milestones achieved by Armata demonstrate a robust pipeline that could lead to a new class of treatments for patients with limited options due to antibiotic resistance.
Armata Pharmaceuticals' focus on bacteriophage therapeutics places it within a niche yet growing segment of the pharmaceutical market that addresses antibiotic resistance. The recent developments reported by the company, including the advancement of its clinical trials and the expansion of its manufacturing capabilities, are likely to capture the attention of healthcare providers and patients looking for alternative treatments. The financial and clinical support from notable organizations underscores the market's recognition of the need for innovative solutions in this space.
As the company prepares for pivotal studies and commercial production, it is important to assess the potential market size for its phage therapeutics and the competitive landscape. If Armata's products can demonstrate superior safety profiles and efficacy, there could be significant market penetration and adoption, leading to a positive impact on the company's financial performance. The preservation of the microbiome and the reduction in opportunistic infections are key differentiators that could influence prescribing behaviors and patient preference, especially in the context of rising antibiotic resistance.
Fourth Quarter 2023 and Recent Developments:
- Continued to advance the Phase 2a portion of the Company's diSArm study of AP-SA02 as a potential treatment for Staphylococcus aureus bacteremia with continued ability to dose escalate due to phage purity, as well as its Phase 2 Tailwind study of AP-PA02 in patients with non-cystic fibrosis bronchiectasis (NCFB).
- Reported that analysis of data from the SWARM-P.a. clinical trial of AP-PA02 in cystic fibrosis patients with Pseudomonas aeruginosa respiratory infections, together with blinded trends from the ongoing Tailwind NCFB study, indicate that treatment with phage alone compared to phage plus antibiotics results in a similar biologic impact.
- Additionally, similar phage distribution and phage kinetics have been observed across both patient populations.
- The specificity of phage for their bacterial targets preserves the normal microbiome compared to subjects receiving standard-of-care antibiotic treatment, diminishing the risk to opportunistic infections.
- Continued to advance bacteriophage science through multiple data presentations and publications:
- Presented topline data from the Company's Phase 1b/2a SWARM-P.a. clinical trial evaluating AP-PA02, a novel, inhaled multi-phage therapeutic for the treatment of chronic pulmonary Pseudomonas aeruginosa infections in people with cystic fibrosis, at the North American Cystic Fibrosis Conference Plenary II session in November 2023.
- Delivered a presentation on the Company's phage development programs at the 6th Annual Bacteriophage Therapy Summit in February 2024.
- Plans to submit a manuscript detailing results from the SWARM-P.a. trial to a peer-reviewed journal in the first half of 2024.
- Progressed the build-out of its advanced biologics manufacturing facility, including completion of R&D labs and administrative space during the fourth quarter of 2023. In the first half of 2024, Armata expects to complete the construction of five large cGMP suites, including a state-of-the-art automated fill and finish suite.
"Since our last quarterly update, we continued to progress toward our mission of addressing the global challenge of antibiotic resistance through the development of high-impact phage therapeutics with best-in-class purity," stated Dr. Deborah Birx, Chief Executive Officer of Armata. "Notably, we have maintained our strategic commitment to investing in rigorous yet efficiently designed randomized studies that, if successful, will support future registration of our high purity phage candidates in areas of significant unmet need."
"Regarding AP-PA02, which we are developing with financial and clinical support from the Cystic Fibrosis Foundation as a potential treatment for Pseudomonas aeruginosa lung infections in patients with cystic fibrosis and non-cystic fibrosis bronchiectasis, analysis of results from trials to date confirm similarities in phage distribution and phage kinetics across both patient populations and strongly validate our phage 'cocktail' approach. Additionally, treatment with phage alone and treatment with phage plus standard-of-care antibiotics appears to have a similar biologic impact. Our Phase 2 Tailwind study in subjects with NCFB is progressing according to plan following an acceleration in enrollment trends that we observed last quarter."
"Regarding our second clinical candidate, AP-SA02, which we are developing with financial assistance from the
"Also, during the fourth quarter, we further optimized our production capabilities to enhance the purity of our phage candidates, which is a key differentiator for us. It is the purity of our candidates that we believe contributes to their favorable safety profile, allowing us to explore higher doses and longer durations of treatment as we prepare for pivotal studies, likely to commence in the first half of 2025. Our state-of-the-art manufacturing facility is nearing completion and will enable us to support both late-stage trials as well as commercial production."
"We continue to achieve important clinical and manufacturing milestones while prudently managing our expenses, and I am excited about what we are poised to achieve this year and next," Dr. Birx concluded.
Fourth Quarter 2023 Financial Results
Grant Revenue. The Company recognized grant revenue of approximately
Research and Development. Research and development expenses for the three months ended December 31, 2023 were approximately
General and Administrative. General and administrative expenses for the three months ended December 31, 2023 were approximately
Loss from Operations. Loss from operations for the three months ended December 31, 2023 was
Cash and Equivalents. As of December 31, 2023, Armata held approximately
On March 4, 2024, the Company entered into a credit and security agreement for a loan in an aggregate amount of
As of March 21, 2024, there were approximately 36.1 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 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 Marina del Rey production facility under fully compliant current Good Manufacturing Practices; meet anticipated milestones in the development and testing of the relevant product; 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) | ||||||
December 31, 2023 | December 31, 2022 | |||||
Assets | ||||||
Current assets | ||||||
Cash and cash equivalents | $ | 13,523 | $ | 14,852 | ||
Prepaid expenses and other current assets | 2,265 | 3,664 | ||||
Other receivables | 3,363 | 8,531 | ||||
Total current assets | 19,151 | 27,047 | ||||
Property and equipment, net | 12,559 | 3,617 | ||||
Operating lease right-of-use asset | 44,717 | 43,035 | ||||
Intangible assets, net | 13,746 | 13,746 | ||||
Other long term assets | 8,190 | 8,389 | ||||
Total assets | $ | 98,363 | $ | 95,834 | ||
Liabilities and stockholders' (deficit) equity | ||||||
Total current liabilities | 16,461 | 24,873 | ||||
Long term debt | 82,307 | — | ||||
Operating lease liabilities, net of current portion | 28,583 | 31,804 | ||||
Deferred tax liability | 3,077 | 3,077 | ||||
Total liabilities | 130,428 | 59,754 | ||||
Stockholders' (deficit) equity | (32,065) | 36,080 | ||||
Total liabilities and stockholders' (deficit) equity | $ | 98,363 | $ | 95,834 | ||
Armata Pharmaceuticals, Inc. Condensed Consolidated Statements of Operations (in thousands, except share and per share data) | |||||||||||||
Three Months Ended | Twelve Months Ended | ||||||||||||
December 31, | December 31, | ||||||||||||
(unaudited) | |||||||||||||
2023 | 2022 | 2023 | 2022 | ||||||||||
Grant revenue | $ | 1,528 | $ | 1,051 | $ | 4,529 | $ | 5,508 | |||||
Operating expenses: | |||||||||||||
Research and development | 7,928 | 9,570 | 33,770 | 35,017 | |||||||||
General and administrative | 3,179 | 1,810 | 11,649 | 7,437 | |||||||||
Total operating expenses | 11,107 | 11,380 | 45,419 | 42,454 | |||||||||
Loss from operations | (9,579) | (10,329) | (40,890) | (36,946) | |||||||||
Interest income | 68 | 14 | 179 | 29 | |||||||||
Interest expense | (1,450) | — | (2,626) | — | |||||||||
Change in fair value of convertible debt | (8,886) | — | (21,845) | — | |||||||||
Loss on convertible debt extinguishment | — | — | (3,863) | — | |||||||||
Net loss | $ | (19,847) | $ | (10,315) | $ | (69,045) | $ | (36,917) | |||||
Net loss per share, basic and diluted | $ | (0.55) | $ | (0.29) | $ | (1.91) | $ | (1.08) | |||||
Weighted average shares outstanding, basic and diluted | 36,100,869 | 36,038,686 | 36,075,555 | 34,294,124 | |||||||||
Armata Pharmaceuticals, Inc. Condensed Consolidated Statements of Cash Flows (in thousands) | |||||||
Year Ended December 31, | |||||||
2023 | 2022 | ||||||
Operating activities: | |||||||
Net loss | $ | (69,045) | $ | (36,917) | |||
Adjustments required to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation and amortization expense | 972 | 892 | |||||
Stock-based compensation expense | 938 | 3,105 | |||||
Change in fair value of convertible debt | 21,845 | — | |||||
Non-cash interest expense | 2,573 | — | |||||
Non-cash interest income | (22) | — | |||||
Loss on convertible debt extinguishment | 3,863 | — | |||||
Change in right-of-use asset | 1,018 | — | |||||
Loss from disposal of property and equipment | 81 | — | |||||
Changes in operating assets and liabilities: | (9,646) | 439 | |||||
Net cash used in operating activities | (47,423) | (32,481) | |||||
Investing activities: | |||||||
Purchases of property and equipment | (8,144) | (2,211) | |||||
Proceeds from sale of property and equipment | 10 | — | |||||
Net cash used in investing activities | (8,134) | (2,211) | |||||
Financing activities: | |||||||
Proceeds from issuance of convertible debt, net of issuance costs | 29,101 | — | |||||
Proceeds from issuance of long-term debt, net of issuance costs | 24,925 | — | |||||
Payment of deferred offering costs | — | (500) | |||||
Proceeds from sale of Common Stock, net of offering costs | — | 44,391 | |||||
Payments for taxes related to net share settlement of equity awards | (43) | — | |||||
Proceeds from exercise of stock options | 5 | 125 | |||||
Net cash provided by financing activities | 53,988 | 44,016 | |||||
Net (decrease) increase in cash, cash equivalents and restricted cash | (1,569) | 9,324 | |||||
Cash, cash equivalents and restricted cash, beginning of period | 20,812 | 11,488 | |||||
Cash, cash equivalents and restricted cash, end of period | $ | 19,243 | $ | 20,812 | |||
Year Ended December 31, | |||||||
2023 | 2022 | ||||||
Cash and cash equivalents | $ | 13,523 | $ | 14,852 | |||
Restricted cash | 5,720 | 5,960 | |||||
Cash, cash equivalents and restricted cash | $ | 19,243 | $ | 20,812 | |||
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SOURCE Armata Pharmaceuticals, Inc.
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