SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of report (Date of earliest event reported): March 13, 2020
ARMATA PHARMACEUTICALS, INC.
(Exact name of Registrant as specified in its charter)
|(State or other jurisdiction of incorporation or
|(Commission File Number)||(IRS Employer Identification No.)|
4503 Glencoe Avenue
Marina del Rey, California
|(Address of principal executive offices)||(Zip Code)|
(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 1.01.||Entry into a Material Definitive Agreement.|
On March 13, 2020, Armata Pharmaceuticals, Inc. (the “Company”) entered into an award agreement (the “Agreement”) with Cystic Fibrosis Foundation (“CFF”), pursuant to which it received a development award of up to $5.0 million (the “Award”). The Award will be used to fund the Company’s Phase 1b/2 clinical trial of the Pseudomonas aeruginosa phage candidate, AP-PA02, as a treatment for Pseudomonas airway infections in people with cystic fibrosis (“CF”).
The first payment under the Agreement, in the amount of $1.0 million, became due upon signing the Agreement. The remainder of the Award will be paid to the Company incrementally in installments upon the achievement of certain milestones related to the development program and progress of the Phase 1b/2 clinical trial of AP-PA02, as set forth in the Agreement.
If the Company ceases to use commercially reasonable efforts directed to the development of AP-PA02, or any other Product (as defined in the Agreement), for a period of time (an “Interruption”) and fails to resume the development of the Product after receiving from CFF notice of an Interruption, then the Company must either repay the amount of the Award actually received by the Company, plus interest, or grant to CFF (1) an exclusive (even as to the Company), worldwide, perpetual, sublicensable license under technology developed under the Agreement that covers the Product for use in treating infections in CF patients (the “CF Field”), and (2) a non-exclusive, worldwide, perpetual, sublicensable license under certain background intellectual property covering the Product, to the extent necessary to commercialize the Product in the CF Field.
Upon commercialization by the Company of any Product, the Company will owe a fixed royalty amount to CFF, which is to be paid in installments determined, in part, based on commercial sales volumes of the Product. The Company will be obligated to make an additional fixed royalty payment upon achieving specified sales milestones. The Company may also be obligated to make a payment to CFF if the Company transfers, sells or licenses the Product in the CF Field, or if the Company enters into a change of control transaction.
The term of the Agreement commenced on March 10, 2020 and expires on the earlier of the date on which the Company has paid CFF all of the royalty payments set forth therein, the effective date of any license granted to CFF following an Interruption, or upon earlier termination of the Agreement. Either CFF or the Company may terminate the agreement for cause, which includes the Company’s material failure to achieve certain development milestones. The Company’s payment obligations survive the termination of the Agreement.
|Item 7.01||Regulation FD Disclosure.|
On March 18, 2020, the Company issued a press release, a copy of which is being furnished as Exhibit 99.1 to this Report on Form 8-K.
The information in this Item 7.01 and Exhibit 99.1 attached hereto is intended to be furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such filing.
|Item 9.01||Financial Statements and Exhibits.|
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: March 19, 2020||Armata Pharmaceuticals, Inc.|
|By:||/s/ Steve R. Martin|
|Name:||Steve R. Martin|
|Title:||Chief Financial Officer|
Armata Pharmaceuticals Announces up to $5 Million Therapeutics Development Award from the
Cystic Fibrosis Foundation
Award to help fund a Phase 1/2 clinical trial of the company’s Pseudomonas aeruginosa phage candidate, AP-PA02, as a treatment for drug-resistant respiratory infections in cystic fibrosis patients
Armata to collaborate with the Cystic Fibrosis Therapeutics Development Network
MARINA DEL REY, California, March 18, 2020 – Armata Pharmaceuticals, Inc. (NYSE American: ARMP) (“Armata”), a biotechnology company focused on precisely targeted bacteriophage therapeutics for antibiotic-resistant infections, today announced that the company has been awarded up to $5 million in a therapeutic development award from the Cystic Fibrosis Foundation (CFF). The award will help fund a Phase 1/2 clinical trial of the company’s Pseudomonas aeruginosa phage candidate, AP-PA02, as a treatment for Pseudomonas airway infections in people with cystic fibrosis (CF). Armata plans to conduct the clinical trial within the Cystic Fibrosis Therapeutics Development Network (TDN), the largest CF clinical trials network in the world. The network brings together experts from across the country to evaluate the safety and effectiveness of new CF therapies through well designed clinical studies.
“Last year, we expedited development of our Pseudomonas aeruginosa phage product candidate, AP-PA02, and elevated it to our lead development program based on the very encouraging results that we observed in our preclinical work,” said Todd R. Patrick, Chief Executive Officer of Armata. “We are pleased that the Cystic Fibrosis Foundation recognizes the potential of phage-based therapeutics as a potential treatment for Pseudomonas airway infections, which are a major cause of morbidity and mortality in people with CF. We are working vigorously to advance AP-PA02 through clinical development as efficiently as possible. We are grateful for the Foundation’s support.”
“Developing new approaches to treat drug resistant pathogens is critical,” said Michael P. Boyle, MD, President and Chief Executive Officer of the U.S. Cystic Fibrosis Foundation. “Better understanding of phage therapy has potential to significantly benefit people with CF as well as millions of others worldwide who are impacted by antibiotic resistant infections.”
Dr. Christopher H. Goss, the Co-Executive Director, TDN Coordinating Center, Seattle Children's Research Institute, and a Professor of Medicine and Pediatrics at the University of Washington, is expected to serve as the lead Principal Investigator for Armata’s upcoming clinical trial of AP-PA02. “The CF community continues to need novel approaches to serious lower airway infections. Armata is addressing this need with phage-based therapeutics. This approach addresses an important unmet need in the CF community and has implications for the treatment of serious infections outside of CF. I am excited to be working with Armata and look forward to the launch of this important clinical study,” said Dr. Goss.
AP-PA02 has been developed as a second-generation version of AP-PA01, which was featured in the peer-reviewed journal Infection following the successful treatment of a multidrug-resistant Pseudomonas aeruginosa infection in a cystic fibrosis patient. AP-PA02 is comprised of a mixture of complementary bacteriophages that provide improved host range, increased potency and aid in preventing the development of resistance.
About the Cystic Fibrosis Foundation
The Cystic Fibrosis Foundation is the world’s leader in the search for a cure for cystic fibrosis. The Foundation funds more CF research than any other organization, and nearly every CF drug available today was made possible because of Foundation support. Based in Bethesda, Md., the Foundation also supports and accredits a national care center network that has been recognized by the National Institutes of Health as a model of care for a chronic disease. The CF Foundation is a donor-supported nonprofit organization. For more information, visit www.cff.org.
About Armata Pharmaceuticals, Inc.
Armata is a clinical-stage biotechnology company focused on the development of precisely targeted bacteriophage therapeutics for the treatment of antibiotic-resistant 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. In addition, in collaboration with Merck, known as MSD outside of the United States and Canada, Armata is developing proprietary synthetic phage candidates to target an undisclosed infectious disease agent. Armata is committed to advancing phage with drug development expertise that spans bench to clinic including in-house phage specific GMP manufacturing. For more information, visit www.armatapharma.com.
Forward Looking Statements
This communication contains "forward-looking" statements, including, without limitation, statements related to the development of AP-PA02, including the anticipated initiation of a clinical trial of AP-PA02. 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 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; Armata’s expected market opportunity for its products; and Armata’s ability to sufficiently fund its future operations as expected. 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 25, 2019, Armata’s Proxy Statement on Schedule 14A, filed with the SEC on April 4, 2019, as amended, and Armata's 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.
Armata Pharmaceuticals, Inc.
Armata Investor Relations:
LifeSci Advisors, LLC
Dan Zacchei / Alex Kovtun
Sloane & Company
firstname.lastname@example.org / email@example.com