Armata Pharmaceuticals Announces Fourth Quarter and Full-Year 2022 Results and Provides Corporate Update
Armata Pharmaceuticals, a biotechnology firm focused on bacteriophage therapeutics, announced its fourth-quarter and full-year 2022 financial results on March 16, 2023. Key highlights include positive topline results from the SWARM-P.a. Phase 1b/2a trial for AP-PA02 in cystic fibrosis patients, which supports its progression to Phase 2b. The company also initiated the Phase 2 study for non-cystic fibrosis bronchiectasis and advanced its AP-SA02 program. Financially, Armata reported Q4 2022 grant revenue of $1.1 million and a loss from operations of $10.3 million, an increase from the previous year. The company concluded the year with $14.9 million in cash.
- Positive results from the SWARM-P.a. Phase 1b/2a trial for AP-PA02, supporting Phase 2b progression.
- Initiation of the Phase 2 non-cystic fibrosis bronchiectasis study.
- Advance of AP-SA02 with the completion of the first cohort dosing in the Staphylococcus aureus study.
- Closure of a $30 million convertible credit agreement with Innoviva, enhancing financial position.
- Loss from operations increased to $(10.3) million in Q4 2022 from $(6.0) million in Q4 2021.
- Research and development expenses rose significantly to approximately $9.6 million, indicating increased financial strain.
Fourth Quarter 2022 and Recent Developments:
- Announced positive topline results from the SWARM-P.a. Phase 1b/2a clinical trial, which evaluated AP-PA02 in cystic fibrosis patients with chronic pulmonary Pseudomonas aeruginosa infections, supporting progression into Phase 2b;
- Announced further clinical progression of AP-PA02 with the first patient dosed in the Phase 2 non-cystic fibrosis bronchiectasis (NCFB) study;
- Advanced AP-SA02 with the completion of first cohort dosing in the Phase 1b/2a Staphylococcus aureus bacteremia study;
- AP-SA02 prosthetic joint infection study start-up activities continue; and
- Closed
$30 million Innoviva Strategic Opportunities LLC , a wholly owned subsidiary of Innoviva, Inc., Armata's largest shareholder.
"During the fourth quarter and subsequent period, we made significant progress across multiple programs, highlighted by the announcement of positive topline results from the SWARM-P.a. Phase 1b/2a clinical trial," stated Dr.
"I am very pleased with what we have accomplished in 2022, and we entered the new year with line-of-sight to data readouts that are essential to advance phage therapy through rigorous clinical trials required to deliver novel treatment options to patients suffering from serious bacterial infections while creating enduring value for our shareholders. Our trials are designed to show the value of phage therapy on top of the standard of care, which if successful, creates the opportunity for broad use of phage therapy. This profile is distinct from the limitations faced by novel antibiotics, which are often reserved for last-line therapy, limiting commercial sales. The Armata team is well-positioned for a successful 2023," concluded
Fourth Quarter 2022 Financial Results
Grant Revenue. The Company recognized grant revenue of approximately
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
Cash and Equivalents. As of
As of
About
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 GMP manufacturing.
Forward Looking Statements
This communication contains "forward-looking" statements, including, without limitation, statements related to Armata's bacteriophage development programs, Armata's ability to set up or operate R&D and manufacturing facilities, Armata's ability to meet expected milestones, Armata's future success or failure, Armata's ability to be a leader in the development of phage-based therapeutics, Armata's expected receipt of grant funding, and statements related to the timing and results of clinical trials, including the anticipated results of clinical trials of AP-PA02 and AP-SA02, and Armata's ability to develop new products based on natural bacteriophages and synthetic bacteriophages. Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements. These forward-looking statements are based upon Armata's current expectations. Forward-looking statements involve risks and uncertainties. Armata's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to the ability of Armata's lead clinical candidates, AP-PA02 and AP-SA02, to be more effective than previous candidates; that the top line results are indicative of the final data; Armata's ability to expedite development of AP-PA02 and AP-SA02; Armata's ability to advance its preclinical and clinical programs and the uncertain and time-consuming regulatory approval process; Armata's ability to develop products based on bacteriophages and synthetic phages to kill bacterial pathogens; the Company's expected market opportunity for its products; Armata's ability to sufficiently fund its operations as expected, including obtaining additional funding as needed; and any delays or adverse events within, or outside of, Armata's control, caused by the ongoing COVID-19 pandemic. 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
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:
ir@armatapharma.com
310-665-2928
Investor Relations:
jallaire@lifesciadvisors.com
212-915-2569
Condensed Consolidated Balance Sheets | ||||||
(Unaudited) | ||||||
Assets | ||||||
Cash and cash equivalents | $ | 14,852,000 | $ | 10,288,000 | ||
Awards receivable | 1,936,000 | 2,989,000 | ||||
Prepaids and other current assets | 10,259,000 | 1,718,000 | ||||
Total current assets | 27,047,000 | 14,995,000 | ||||
Property and equipment, net | 46,652,000 | 38,072,000 | ||||
Other long-term assets | 8,389,000 | 2,955,000 | ||||
Intangible assets, net | 13,746,000 | 13,746,000 | ||||
Total assets | $ | 95,834,000 | $ | 69,768,000 | ||
Liabilities and stockholders' equity | ||||||
Total current liabilities | $ | 24,873,000 | $ | 4,814,000 | ||
Long term liabilities | 31,804,000 | 36,480,000 | ||||
Deferred tax liability | 3,077,000 | 3,077,000 | ||||
Total liabilities | 59,754,000 | 44,371,000 | ||||
Stockholders' equity | 36,080,000 | 25,397,000 | ||||
Total liabilities and stockholders' equity | $ | 95,834,000 | $ | 69,768,000 | ||
Condensed Consolidated Statements of Operations | ||||||||||||
(Unaudited) | ||||||||||||
Three Months Ended | Twelve Months Ended | |||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||
Grant Revenue | $ | 1,051,000 | $ | 989,000 | $ | 5,508,000 | $ | 4,474,000 | ||||
Operating expenses: | ||||||||||||
Research and development | 9,570,000 | 4,814,000 | 35,017,000 | 20,015,000 | ||||||||
General and administrative | 1,810,000 | 2,222,000 | 7,437,000 | 8,281,000 | ||||||||
Total operating expenses | 11,380,000 | 7,036,000 | 42,454,000 | 28,296,000 | ||||||||
Loss from operations | (10,329,000) | (6,047,000) | (36,946,000) | (23,822,000) | ||||||||
Other income (expense), net | 14,000 | - | 29,000 | 667,000 | ||||||||
Loss before income taxes and Net Loss | $ | (10,315,000) | $ | (6,047,000) | $ | (36,917,000) | $ | (23,155,000 | ||||
Net loss per share, basic and diluted | $ | (0.29) | $ | (0.23) | $ | (1.08) | $ | (0.96) | ||||
Weighted average shares outstanding, basic and diluted | 36,045,040 | 26,303,081 | 34,294,124 | 24,104,146 | ||||||||
Condensed Consolidated Statements of Cash Flows | ||||||
(Unaudited) | ||||||
Twelve Months Ended | ||||||
2022 | 2021 | |||||
Operating activities: | ||||||
Net loss | $ | (36,917,000) | $ | (23,155,000) | ||
Adjustments required to reconcile net loss to net cash used in operating activities: | ||||||
Stock-based compensation | 3,105,000 | 2,882,000 | ||||
Depreciation | 892,000 | 1,169,000 | ||||
Payment of accreted interest for deferred consideration for asset acquisition | — | (586,000) | ||||
Non-cash interest expense | — | 60,000 | ||||
Gain on Extinguishment of PPP loan | — | (722,000) | ||||
Changes in operating assets and liabilities, net | 439,000 | (3,223,000) | ||||
Net cash used in operating activities | (32,481,000) | (23,575,000) | ||||
Investing activities: | ||||||
Purchases of property and equipment, net | (2,211,000) | (1,304,000) | ||||
Net cash used in investing activities | (2,211,000) | (1,304,000) | ||||
Financing activities: | ||||||
Payment of deferred consideration for asset acquisition | — | (1,414,000) | ||||
Payment of deferred offering costs | (500,000) | — | ||||
Proceeds from sale of common stock, net of offering costs | 44,391,000 | 26,319,000 | ||||
Proceeds from exercise of warrants and stock options | 125,000 | 613,000 | ||||
Net cash provided by (used in) financing activities | 44,016,000 | 25,518,000 | ||||
Net increase (decrease) in cash and cash equivalents | 9,324,000 | 639,000 | ||||
Cash, cash equivalents and restricted cash, beginning of period | 11,488,000 | 10,849,000 | ||||
Cash, cash equivalents and restricted cash, end of period | $ | 20,812,000 | $ | 11,488,000 | ||
Reconciliation of Cash and cash equivalents: | As of | |||||
2022 | 2021 | |||||
Cash and cash equivalents | $ | 14,852,000 | $ | 10,288,000 | ||
Restricted cash | 5,960,000 | 1,200,000 | ||||
Cash, cash equivalents and restricted cash | $ | 20,812,000 | $ | 11,488,000 | ||
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