ARMP Armata Pharmaceuticals Inc

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 20549

 

FORM 8-K

 

CURRENT REPORT

 

Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934

 

Date of report (Date of earliest event reported): August 14, 2023

 

ARMATA PHARMACEUTICALS, INC.

(Exact name of Registrant as specified in its charter)

 

Washington		001-37544		91-1549568
(State or other jurisdiction of incorporation or organization)		(Commission File Number)		(IRS Employer Identification No.)

 

4503 Glencoe Avenue Marina del Rey, California		90292
(Address of principal executive offices)		(Zip Code)

 

(310) 655-2928

(Registrant’s Telephone number)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Registrant under any of the following provisions (see General Instruction A.2. below):

 

¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of Each Class		Trading Symbol(s)		Name of Each Exchange on Which Registered
Common Stock		ARMP		NYSE American

 

 

 

Item 2.02

Results of Operations and Financial Condition.

 

On August 14, 2023, Armata Pharmaceuticals, Inc. (the “Company”) announced its financial results for the quarter ended June 30, 2023, in the press release furnished hereto as Exhibit 99.1.

 

The information in this Item 2.02 and the attached Exhibit 99.1 is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Item 2.02 and the attached Exhibit 99.1 shall not be incorporated by reference into any registration statement or other document pursuant to the Securities Act of 1933, as amended.

 

Item 9.01

Financial Statements and Exhibits.

 

(d)

Exhibits.

 

Exhibit No.		Description
99.1		Press Release, dated August 14, 2023.
104		Cover Page Interactive Data File (embedded within Inline XBRL document).

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: August 14, 2023	Armata Pharmaceuticals, Inc.
	By:	/s/ Julianne Averill
	Name:	Julianne Averill
	Title:	Chief Financial Officer

 

 

 

Exhibit 99.1

 

Armata Pharmaceuticals Announces Second Quarter 2023 Results and Provides Corporate Update

 

LOS ANGELES, Calif., August 14, 2023 -- Armata Pharmaceuticals, Inc. (NYSE American: ARMP) (“Armata” or the “Company”), a biotechnology company focused on pathogen-specific bacteriophage therapeutics for antibiotic-resistant and difficult-to-treat bacterial infections, today announced financial results for its second quarter ended June 30, 2023, and provided a corporate update.

 

Second Quarter 2023 and Recent Developments:

 

·

Announced leadership transition whereby world-renowned healthcare leader and former Innoviva Board member Dr. Deborah L. Birx has been appointed Armata’s new Chief Executive Officer. Dr. Birx has also been appointed to Armata’s Board of Directors;

 

·

Entered into new credit agreement with Innoviva, the Company’s largest shareholder, for gross proceeds of $25 million, and executed an amendment to its existing senior convertible credit and security agreement with Innoviva, extending the maturity date to January 10, 2025;

 

·

Continued enrollment in the Phase 2 study (“Tailwind”) of inhaled AP-PA02 in patients with non-cystic fibrosis bronchiectasis (NCFB) and chronic Pseudomonas aeruginosa respiratory infection;

 

·

Further analyzed clinical data from the SWARM-P.a. study with the goal of advancing AP-PA02 into a Phase 2b/3 registrational study in cystic fibrosis (CF) patients in 2024;

 

·

Completed enrollment as planned of the Phase 1b part of the Phase 1b/2a study of AP-SA02 in Staphylococcus aureus bacteremia (“diSArm”); Company anticipates initiating the Phase 2a part of the study in 3Q23;

 

·

Commenced feasibility analysis of enrolling AP-SA02 prosthetic joint infection (PJI) study subjects at current “diSArm” sites for potential dual use enrollment in Q3-Q4 2023;

 

·

Progressed the build-out of its new advanced biologics cGMP facility that will provide the company with the manufacturing capacity to pursue partnership opportunities while also executing late-stage trials; and,

 

·

Delivered an oral presentation on the Company's recently completed Phase 1b/2a SWARM-P.a. clinical trial at the 6th World Conference on Targeting Phage Therapy, which was held June 1-2, 2023, in Paris.

 

“I am pleased to report significant progress during the second quarter, as we continued to advance two critical pathway clinical studies while preparing to initiate a third,” stated Dr. Deborah Birx, Chief Executive Officer. “For AP-PA02, our five-phage cocktail targeting Pseudomonas aeruginosa, we continue to analyze results from our SWARM-P.a. study with the goal of progressing to a Phase 2b/3 registrational study in adult cystic fibrosis patients in 2024. At the same time, we have incorporated important learnings from this study into our ongoing Phase 2 trial of AP-PA02 in patients with non-cystic fibrosis bronchiectasis.”

 

“Regarding our second clinical candidate, AP-SA02, we are concluding the Phase 1b part of our Staphylococcus aureus complicated bacteremia study in partnership with the U.S. Department of Defense, with plans to initiate the Phase 2a part this quarter. We are excited to observe that the phage cocktail is well tolerated every six hours intravenously, opening the door to direct clinical evidence from the Phase 2a part and the potential for an accelerated 2b/3 registrational study. Based on AP-SA02’s favorable tolerability profile, we are in parallel advancing start-up activities for a second trial that will evaluate this cocktail as a potential treatment for S. aureus prosthetic joint infections.”

 

 

 

“I am pleased with our progress to date, and, with our strengthened balance sheet, laser focus, and clearly defined strategy, we look forward to a productive back half of the year as we work towards introducing phage therapy as a much-needed novel treatment for a broad range of dangerous, drug-resistant pathogens,” Dr. Birx concluded.

 

Second Quarter 2023 Financial Results

 

Grant Revenue. The Company recognized grant revenue of approximately $1.0 million for the three months ended June 30, 2023, which represents Medical Technology Enterprise Consortium (“MTEC”)’s share of the costs incurred for the Company’s AP-SA02 program for the treatment of Staphylococcus aureus bacteremia. The Company expects to receive $16.3 million in grant funding from MTEC administered by the U.S. Department of Defense and the Defense Health Agency and Joint Warfighter Medical Research Program. The Company recognized approximately $1.9 million of revenue in the comparable period in 2022.

 

Research and Development. Research and development expenses for the three months ended June 30, 2023 were approximately $8.3 million as compared to approximately $9.0 million for the comparable period in 2022. The Company continues to invest in clinical trial and personnel related expenses associated with its primary development programs.

 

General and Administrative. General and administrative expenses for the three months ended June 30, 2023 were approximately $2.4 million as compared to approximately $2.1 million for the comparable period in 2022. The increase was primarily related to expenses related to the increased legal and professional expenses.

 

Loss from Operations. Loss from operations for the three months ended June 30, 2023 was $(9.6) million as compared to a loss from operations of approximately $(9.2) million for the comparable period in 2022.

 

Cash and Equivalents. As of June 30, 2023, Armata held approximately $12.5 million of unrestricted cash and cash equivalents, as compared to $14.9 million as of December 31, 2022. Subsequent to the end of the second quarter, Armata announced a new credit agreement with Innoviva for gross proceeds totaling $25 million.

 

As of August 8, 2023, 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 GMP manufacturing.

 

 

 

Forward Looking Statements

 

This communication contains "forward-looking" statements as defined by the Private Securities Litigation Reform Act of 1995, 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, and statements related to the timing and results of clinical trials, including the anticipated results of clinical trials of AP-PA02 and AP-SA02, Armata’s ability to develop new products based on natural bacteriophages and synthetic bacteriophages and Armata’s ability to obtain additional funding and capacity to repay, refinance, or restructure its existing debt and obligations. 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 SEC, including in Armata's Annual Report on Form 10-K, filed with the SEC on March 16, 2023, 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

Armata Pharmaceuticals, Inc.

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

(Unaudited)

 

		June 30, 2023				December 31, 2022
Assets
Cash and cash equivalents		$	12,456,000			$	14,852,000
Prepaid expenses			5,745,000				3,664,000
Other receivable			8,633,000				8,531,000
Total current assets			26,834,000				27,047,000
Property and equipment, net			8,807,000				3,617,000
Operating lease right-of-use assets			43,652,000				43,035,000
Other long term assets			8,173,000				8,389,000
Intangible assets, net			13,746,000				13,746,000
Total assets		$	101,212,000			$	95,834,000
Liabilities and shareholders’ equity
Convertible debt		$	26,352,000			$	-
Other current liabilities			25,210,000				24,873,000
Total current liabilities			51,562,000				24,873,000
Long term liabilities			27,430,000				31,804,000
Deferred tax liability			3,077,000				3,077,000
Total liabilities			82,069,000				59,754,000
Shareholders’ equity			19,143,000				36,080,000
Total liabilities and shareholders’ equity		$	101,212,000			$	95,834,000

 

 

 

Armata Pharmaceuticals, Inc.

Condensed Consolidated Statements of Operations 

 

		Three Months Ended June 30,								Six Months Ended June 30,
		2023				2022				2023				2022
		(Unaudited)				(Unaudited)				(Unaudited)				(Unaudited)
Grant Revenue		$	980,000			$	1,883,000			$	1,776,000			$	3,119,000
Operating expenses:
Research and development			8,259,000				9,020,000				17,863,000				17,048,000
General and administrative			2,350,000				2,083,000				4,888,000				4,066,000
Total operating expenses			10,609,000				11,103,000				22,751,000				21,114,000
Loss from operations			(9,629,000	)			(9,220,000	)			(20,975,000	)			(17,995,000	)
Other income (expense), net			46,000				5,000				64,000				6,000
Change in fair value of convertible debt			6,036,000				-				2,874,000				-
Loss before income taxes and Net Loss		$	(3,547,000	)		$	(9,215,000	)		$	(18,037,000	)		$	(17,989,000	)
Net loss per share, basic		$	(0.10	)		$	(0.26	)		$	(0.50	)		$	(0.55	)
Weighted average shares outstanding, basic			36,068,130				35,999,642				36,056,649				32,517,416
Net loss per share, diluted		$	(0.17	)		$	(0.26	)		$	(0.50	)		$	(0.55	)
Weighted average shares outstanding, diluted			56,544,698				35,999,642				36,056,649				32,517,416

 

 

 

Armata Pharmaceuticals, Inc.

Condensed Consolidated Statements of Cash Flows 

 

		Six Months Ended June 30,
		2023				2022
Operating activities:
Net loss		$	(18,037,000	)		$	(17,989,000	)
Adjustments required to reconcile net loss to net cash used in operating activities:
Share-based compensation			1,118,000				1,442,000
Depreciation			458,000				421,000
Change in fair value of convertible debt			(2,874,000	)			-
Changes in operating assets and liabilities, net			(10,295,000	)			4,463,000
Net cash used in operating activities			(29,630,000	)			(11,663,000	)
Investing activities:
Purchases of property and equipment, net			(2,232,000	)			(1,372,000	)
Net cash used in investing activities			(2,232,000	)			(1,372,000	)
Financing activities:
Proceeds from issuance of convertible debt, net			29,226,000				-
Proceeds from sale of common shares, net of offering costs			-				44,414,000
Proceeds from exercise of warrants and share-based options			-				71,000
Net cash provided by (used in) financing activities			29,226,000				44,485,000
Net increase (decrease) in cash and cash equivalents			(2,636,000	)			31,450,000
Cash, cash equivalents and restricted cash, beginning of period			20,812,000				11,488,000
Cash, cash equivalents and restricted cash, end of period		$	18,176,000			$	42,938,000

 

		Six Months Ended June 30,
		2023				2022
Reconciliation of Cash and cash equivalents:
Cash and cash equivalents		$	12,456,000			$	36,978,000
Restricted cash			5,720,000				5,960,000
Cash, cash equivalents and restricted cash		$	18,176,000			$	42,938,000

 

 

v3.23.2

Cover	Aug. 14, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 14, 2023
Entity File Number	001-37544
Entity Registrant Name	ARMATA PHARMACEUTICALS, INC.
Entity Central Index Key	0000921114
Entity Tax Identification Number	91-1549568
Entity Incorporation, State or Country Code	WA
Entity Address, Address Line One	4503 Glencoe Avenue
Entity Address, City or Town	Marina del Rey
Entity Address, State or Province	CA
Entity Address, Postal Zip Code	90292
City Area Code	310
Local Phone Number	655-2928
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock
Trading Symbol	ARMP
Security Exchange Name	NYSEAMER
Entity Emerging Growth Company	false

---