Armata Pharmaceuticals Announces First Quarter 2024 Results and Provides Corporate Update
First Quarter 2024 and Recent Developments:
- Entered into a
$35.0 million secured credit agreement withInnoviva Strategic Opportunities LLC , a wholly-owned subsidiary of Innoviva, Armata's principal shareholder. - Continued to advance the Phase 2a portion of the diSArm study of intravenous AP-SA02 as a potential treatment for Staphylococcus aureus bacteremia with continued ability to dose escalate due to phage purity, as well as the Phase 2 Tailwind study of inhaled AP-PA02 in patients with non-cystic fibrosis bronchiectasis (NCFB) and chronic pulmonary Pseudomonas aeruginosa infection ("P.aeruginosa").
- Further advanced bacteriophage science through presentations and publications:
- Delivered a presentation on the Company's phage development programs at the 6th Annual Bacteriophage Therapy Summit in
February 2024 . - Manuscript of results from SWARM-P.a., the completed Phase 1b/2a clinical trial of inhaled AP-PA02 in patients with cystic fibrosis and chronic pulmonary P. aeruginosa infection, expected to be submitted to a peer-reviewed journal in the second quarter of 2024.
- Delivered a presentation on the Company's phage development programs at the 6th Annual Bacteriophage Therapy Summit in
- In the second quarter of 2024, Armata expects to complete 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; R&D labs and administrative space were fully operational in the first quarter of 2024.
"During the first quarter of 2024, we continued to advance our two distinct clinical programs that we believe will support the initiation of rigorously designed pivotal studies, which we are planning for 2025," stated Dr.
"For AP-SA02, developed with support from the
"The Company strengthened its balance sheet during the quarter with a
"We entered the final stages of the build-out of our state-of-the-art cGMP manufacturing facility, which is expected to be completed mid-year, at which time we expect to be well-positioned to support our late-stage clinical trials and commercial production."
"Having committed to the execution of randomized, placebo-controlled clinical studies that, if successful, will support eventual registration of our multi-phage products, I am very pleased with our progress to date, and believe that we are within line-of-sight to achieve value creating milestones this year and the next,"
First Quarter 2024 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. 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 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
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
Armata Pharmaceuticals, Inc. |
|||||||
Condensed Consolidated Balance Sheets |
|||||||
(in thousands) |
|||||||
(unaudited) |
|||||||
|
|||||||
|
|
|
|
|
|
||
Assets |
|
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
|
Cash |
|
$ |
37,860 |
|
$ |
13,523 |
|
Prepaid expenses and other current assets |
|
|
2,143 |
|
|
2,265 |
|
Other receivables |
|
|
1,714 |
|
|
3,363 |
|
Total current assets |
|
|
41,717 |
|
|
19,151 |
|
Property and equipment, net |
|
|
12,700 |
|
|
12,559 |
|
Operating lease right-of-use asset |
|
|
44,243 |
|
|
44,717 |
|
Intangible assets, net |
|
|
13,746 |
|
|
13,746 |
|
Other long term assets |
|
|
7,950 |
|
|
8,190 |
|
Total assets |
|
$ |
120,356 |
|
$ |
98,363 |
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' deficit |
|
|
|
|
|
|
|
Total current liabilities |
|
$ |
110,045 |
|
$ |
16,461 |
|
Long-term debt |
|
|
35,368 |
|
|
82,307 |
|
Operating lease liabilities, net of current portion |
|
|
28,376 |
|
|
28,583 |
|
Deferred tax liability |
|
|
3,077 |
|
|
3,077 |
|
Total liabilities |
|
|
176,866 |
|
|
130,428 |
|
Stockholders' deficit |
|
|
(56,510) |
|
|
(32,065) |
|
Total liabilities and stockholders' deficit |
|
$ |
120,356 |
|
$ |
98,363 |
|
Armata Pharmaceuticals, Inc. |
|||||||
Condensed Consolidated Statements of Operations |
|||||||
(in thousands, except share and per share data ) |
|||||||
(unaudited) |
|||||||
|
|||||||
|
|
Three Months Ended |
|
||||
|
|
|
|
||||
|
|
2024 |
|
2023 |
|
||
Grant revenue |
|
$ |
966 |
|
$ |
796 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
|
8,016 |
|
|
9,604 |
|
General and administrative |
|
|
3,178 |
|
|
2,538 |
|
Total operating expenses |
|
|
11,194 |
|
|
12,142 |
|
Loss from operations |
|
|
(10,228) |
|
|
(11,346) |
|
Interest income |
|
|
52 |
|
|
18 |
|
Interest expense |
|
|
(1,820) |
|
|
— |
|
Change in fair value of convertible debt |
|
|
(13,025) |
|
|
(3,162) |
|
Net loss |
|
$ |
(25,021) |
|
$ |
(14,490) |
|
Net loss per share, basic and diluted |
|
$ |
(0.69) |
|
$ |
(0.40) |
|
Weighted average shares outstanding, basic and diluted |
|
|
36,124,980 |
|
|
36,045,040 |
|
Armata Pharmaceuticals, Inc. |
|||||||
Condensed Consolidated Statements of Cash Flows |
|||||||
(in thousands) |
|||||||
(unaudited) |
|||||||
|
|||||||
|
|
Three Months Ended |
|
||||
|
|
2024 |
|
2023 |
|
||
Operating activities: |
|
|
|
|
|
|
|
Net loss |
|
$ |
(25,021) |
|
$ |
(14,490) |
|
Adjustments required to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
Depreciation and amortization expense |
|
|
317 |
|
|
230 |
|
Stock-based compensation expense |
|
|
534 |
|
|
857 |
|
Change in fair value of convertible debt |
|
|
13,025 |
|
|
3,162 |
|
Non-cash interest expense |
|
|
1,815 |
|
|
— |
|
Non-cash interest income |
|
|
(26) |
|
|
— |
|
Change in right-of-use asset |
|
|
464 |
|
|
— |
|
Changes in operating assets and liabilities: |
|
|
(1,692) |
|
|
(7,329) |
|
Net cash used in operating activities |
|
|
(10,584) |
|
|
(17,570) |
|
Investing activities: |
|
|
|
|
|
|
|
Purchases of property and equipment |
|
|
(250) |
|
|
(2,010) |
|
Net cash used in investing activities |
|
|
(250) |
|
|
(2,010) |
|
Financing activities: |
|
|
|
|
|
|
|
Proceeds from issuance of convertible debt, net of issuance costs |
|
|
— |
|
|
29,594 |
|
Proceeds from issuance of long-term debt, net of issuance costs |
|
|
34,889 |
|
|
— |
|
Proceeds from exercise of stock options |
|
|
42 |
|
|
— |
|
Net cash provided by financing activities |
|
|
34,931 |
|
|
29,594 |
|
Net increase in cash and restricted cash |
|
|
24,097 |
|
|
10,014 |
|
Cash and restricted cash, beginning of period |
|
|
19,243 |
|
|
20,812 |
|
Cash and restricted cash, end of period |
|
$ |
43,340 |
|
$ |
30,826 |
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|||||
|
|
2024 |
|
2023 |
|||
Cash |
|
$ |
37,860 |
|
$ |
25,106 |
|
Restricted cash |
|
|
5,480 |
|
|
5,720 |
|
Cash and restricted cash |
|
$ |
43,340 |
|
$ |
30,826 |
View original content to download multimedia:https://www.prnewswire.com/news-releases/armata-pharmaceuticals-announces-first-quarter-2024-results-and-provides-corporate-update-302137803.html
SOURCE