Armata Pharmaceuticals Announces Second Quarter 2024 Results and Provides Corporate Update
Rhea-AI Summary
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.
Positive
- 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
Negative
- 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
News Market Reaction 1 Alert
On the day this news was published, ARMP declined 10.70%, reflecting a significant negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
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 | |||
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SOURCE Armata Pharmaceuticals, Inc.