29 Jan 2018

Armis Biopharma Granted QIDP for Lead Product, Ximycin™ for Prophylaxis of Surgical Site Infections in High-Risk Patients Undergoing Non-Emergent Colorectal Surgery

– Ximycin is the first targeted medical therapeutic for the prevention or treatment of surgical site infections –

 

– Company on track to initiate Phase 3 clinical program in first half of 2018 –

 

Fort Collins, CO (January 29, 2018) Armis Biopharma, Inc. (“Armis” or the “Company”), a late- stage clinical biopharmaceutical company with a growing pipeline of targeted anti-infective therapeutics designed to address the serious and rapidly growing phenomenon of antibiotic resistance and healthcare-associated infections, announced today that the U.S. Food and Drug Administration (FDA) has designated the Company’s lead product in development, Ximycin, as a Qualified Infectious Disease Product (QIDP) for prophylactic treatment of surgical site infections in high-risk patients undergoing non-emergent colorectal surgery.

Ximycin, the Company’s lead product candidate, is a patented, first-of-its-kind localized antimicrobial therapy derived from a combination of a gram-positive agent, vancomycin, and a gram-negative agent, gentamicin, two potent well-established and accepted agents. Ximycin utilizes a proprietary sustained-release delivery method via gel formulation, enabling temporally- extended, broad spectrum polymicrobial coverage in the incision site. Ximycin is initially being developed for use as a prophylactic therapy for the mitigation or prevention of multi-drug resistant surgical site infections (“SSIs”), including multi-drug resistant gram-negative and/or gram-positive infections.

Mike Handley, Chief Executive Officer of Armis, commented, “QIDP designation for Ximycin marks an important milestone in our clinical and regulatory strategy for our flagship development program. Also, QIDP designation as defined by the Generating Anti-Infectives Now (“GAIN”) Act is reserved for new drugs that are, “intended to treat serious or life-threatening infections.”

“We have compiled a robust clinical data package in approximately 700 patients, which we believe de-risks our clinical development program and importantly, supports Ximycin’s commercial potential as the first targeted medical therapeutic for the prevention of surgical site infections in high-risk patients undergoing non-emergent colorectal surgery. Our priorities are clear, and we are highly focused on executing on our plan to initiate our pivotal Phase 3 program in the first half of 2018,” added Mr. Handley.

QIDP designation, provided under the Generating Antibiotic Incentives Now Act (GAIN Act), offers certain incentives for the development of new antibacterial or antifungal drugs, including eligibility for Fast Track, priority review and, if Ximycin is ultimately approved by the FDA, eligibility for an additional five years of marketing exclusivity.

About Armis Biopharma, Inc.

Armis Biopharma is a late-stage clinical biopharmaceutical company with a growing pipeline of targeted anti-infective therapeutics designed to address the serious and rapidly growing phenomenon of antibiotic resistance and healthcare-associated infections.

The Company’s lead product candidate, Ximycin™, is a patented, first-of-its-kind localized antimicrobial therapy derived from a combination of a gram-positive agent, vancomycin, and a gram-negative agent, gentamicin, two potent well-established and accepted agents. Ximycin™ utilizes a proprietary sustained-release delivery method via gel formulation, enabling temporally- extended, broad spectrum polymicrobial coverage in the incision site. Ximycin is initially being developed for use as a prophylactic therapy for the mitigation or prevention of multi-drug resistant surgical site infections (“SSIs”), including multi-drug resistant gram-negative and/or gram-positive infections.

Armis is also focused on developing and commercializing a proprietary, first-of-its-kind, peracid- based anti-infective technology and acquiring other synergistic technologies/products. For more information about the Company, visit www.armisbiopharma.com.

Forward-Looking Statements

This press release contains certain forward-looking statements, including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statements that are predictive in nature. The Company has made every reasonable effort to ensure the information and assumptions on which these statements are based are current, reasonable and complete. However, a variety of factors, many of which are beyond the Company’s control, affect the Company’s operations, performance, business strategy and results and there can be no assurances that the Company’s actual results will not differ materially from those indicated herein. Additional written and oral forward-looking statements may be made by the Company from time to time. The Private Securities Litigation Reform Act of 1995 provides a safe-harbor for forward-looking statements. These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this presentation. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

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Email: jtc@jtcir.com