Armata Pharmaceuticals Announces Fourth Quarter and Full-Year 2023 Results and Provides Corporate Update
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.
- 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
- 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.
"Regarding AP-PA02, which we are developing with financial and clinical support from the
"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,"
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
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
On
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 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
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 (in thousands) |
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Assets |
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Current assets |
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|
|
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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 |
|
|
|
|
|
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Liabilities and stockholders' (deficit) equity |
|
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|
|
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Total current liabilities |
|
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16,461 |
|
|
24,873 |
Long term debt |
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|
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 |
|
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(32,065) |
|
|
36,080 |
Total liabilities and stockholders' (deficit) equity |
|
$ |
98,363 |
|
$ |
95,834 |
Condensed Consolidated Statements of Operations (in thousands, except share and per share data ) |
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Three Months Ended |
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Twelve Months Ended |
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(unaudited) |
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2023 |
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2022 |
|
2023 |
|
2022 |
|
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Grant revenue |
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$ |
1,528 |
|
$ |
1,051 |
|
$ |
4,529 |
|
$ |
5,508 |
|
Operating expenses: |
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|
|
|
|
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|
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Research and development |
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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) |
|
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(40,890) |
|
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(36,946) |
|
Interest income |
|
|
68 |
|
|
14 |
|
|
179 |
|
|
29 |
|
Interest expense |
|
|
(1,450) |
|
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— |
|
|
(2,626) |
|
|
— |
|
Change in fair value of convertible debt |
|
|
(8,886) |
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|
— |
|
|
(21,845) |
|
|
— |
|
Loss on convertible debt extinguishment |
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— |
|
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— |
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|
(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 |
|
Condensed Consolidated Statements of Cash Flows (in thousands) |
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Year Ended |
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2023 |
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2022 |
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Operating activities: |
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Net loss |
|
$ |
(69,045) |
|
$ |
(36,917) |
|
Adjustments required to reconcile net loss to net cash used in operating activities: |
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|
|
|
|
|
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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 |
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|
2,573 |
|
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— |
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Non-cash interest income |
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(22) |
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— |
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Loss on convertible debt extinguishment |
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|
3,863 |
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— |
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Change in right-of-use asset |
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|
1,018 |
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— |
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Loss from disposal of property and equipment |
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|
81 |
|
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— |
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Changes in operating assets and liabilities: |
|
|
(9,646) |
|
|
439 |
|
Net cash used in operating activities |
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|
(47,423) |
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|
(32,481) |
|
Investing activities: |
|
|
|
|
|
|
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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: |
|
|
|
|
|
|
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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 |
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|
— |
|
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(500) |
|
Proceeds from sale of Common Stock, net of offering costs |
|
|
— |
|
|
44,391 |
|
Payments for taxes related to net share settlement of equity awards |
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(43) |
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— |
|
Proceeds from exercise of stock options |
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|
5 |
|
|
125 |
|
Net cash provided by financing activities |
|
|
53,988 |
|
|
44,016 |
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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 |
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Year Ended |
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2023 |
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2022 |
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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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