Amplyx Announces Presentations on APX001 at American Society for Microbiology Microbe 2018 and the 20th Symposium on Infections in the Immunocompromised Host

SAN DIEGO – June 7, 2018 – Amplyx Pharmaceuticals, a company developing first-in-class products for life-threatening infections, today announced that Amplyx and its collaborators will be participating in and presenting at two scientific conferences in the upcoming weeks. Presentations will focus on the company’s lead drug candidate, APX001, which is currently in development for the treatment of invasive fungal infections.

“The new preclinical data to be presented at the ASM conference indicate that APX001 is highly active in a murine model of coccidioidomycosis, commonly known as Valley Fever,” said Karen Joy Shaw, Ph.D., Amplyx’s chief scientific officer. “These results are further evidence that APX001 may be useful in a broad spectrum of fungal infections.”

Valley Fever, which is endemic in the Southwestern United States, most notably in Arizona and California, is caused by a fungus that grows in the soil. Symptoms of Valley Fever include extreme fatigue, fever, cough, headache, rash and muscle or joint pain. It is most common in the elderly and immunocompromised, and ~10,000 cases are reported in the US each year.

Presentation details:

American Society for Microbiology (ASM) Microbe 2018

Session: Lounge and Learn 1: “Early New Antimicrobial Agents”
Date: Friday, June 8
Time: 8:45-10:45 AM EST
Presenter: Karen Joy Shaw, Ph.D., chief scientific officer, Amplyx Pharmaceuticals, Inc
Location: Georgia World Congress Center Building A Level 4, Atlanta, Georgia

Poster: #488: “APX001 is Effective Treatment for Murine Coccidioidomycosis”

Track: Antifungal Agents and Resistance

Date: Friday, June 8
Time: 11:00 AM-1:00 PM EST
Presenter: Joshua Fierer, M.D., chief, Infectious Diseases Section, Veterans Affairs, San Diego Healthcare System
Location: Georgia World Congress Center Exhibit and Poster Hall, Building B Halls B2-B5, Atlanta, Georgia

Full abstracts can be accessed through the ASM Microbe website.

20^th Symposium on Infections in the Immunocompromised Host (ICHS 2018)

Session: Industry Symposium “New Antifungals”
Title: APX001: A Novel Antifungal to Treat Life Threatening Invasive Fungal Infections

Date: Sunday, June 17
Time: 12:00-1:00 PM
Presenter: David S. Perlin, Ph.D., executive director and professor, New Jersey Medical School- Rutgers
Location: Hotel Divani Acropolis (Erectheion Room), Athens, Greece

About APX001

APX001 is the prodrug of APX001A, which is a first-in-class small molecule drug candidate that inhibits the highly conserved fungal enzyme Gwt1, compromising growth of major fungal pathogens, including Candida and Aspergillus. The novel mechanism of action of APX001 translates into a highly versatile drug that demonstrates activity against drug-resistant strains and can be delivered in both oral and intravenous formulations. In multiple nonclinical studies, APX001A has shown broad-spectrum activity against common species of Candida spp., and Aspergillus spp., including multi-drug resistant strains including Candida auris and rare, hard-to-treat molds including Fusarium spp., Scedosporium spp., and fungi from the Mucorales order.

Invasive infections due to Aspergillus, Fusarium, Scedosporium and fungi from the Mucorales order are especially difficult to treat resulting in high mortality rates (50-80%), even when patients receive standard of care treatment. As with multidrug-resistant bacteria, the frequency of fungi resistant to both the azole and candin classes of drugs is increasing. Thus, there remains a significant unmet medical need for a new broad-spectrum antifungal to treat serious, invasive fungal infections and reduce the existing high morbidity and mortality.

About Amplyx Pharmaceuticals

Amplyx Pharmaceuticals is developing first-in-class products for life-threatening infections, with a near-term focus on deadly fungal pathogens in vulnerable patients. Amplyx’s drug discovery and development efforts have been supported by significant venture investment and grants from the National Institutes of Health. For more information, please visit www.amplyx.com.

Media Contact:
Heidi Chokeir, Ph.D.
Managing Director
Canale Communications
(619) 849-5377
heidi@canalecomm.com

Investor Contact:
Mary Gieson
Amplyx Pharmaceuticals, Inc.
(858) 876-6534
mgieson@amplyx.com

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Michael N. Dudley, Pharm.D.

President and Chief Executive Officer
Qpex Biopharma, Inc.

Dr. Dudley has over 30 years of experience in antiinfective drug research, development, and commercialization. In 2018, he co-founded Qpex Biopharma which raised $33M in Series A financing and acquired the preclinical infectious disease programs from The Medicines Company. He has overseen the development and regulatory approval of 3 antibiotics, most recently a beta-lactamase inhibitor combination product from a new chemical class (vaborbactam) discovered in the company laboratories. The antibiotic product Vabomere™ advanced from discovery to FDA approval in 2017 in less than 8 years. He lead the negotiation for multiple contracts from public-private partnerships (e.g., BARDA of the US Government; Innovative Medicines Initiative for the EU) for a combined total of over $190 million funding to advance antimicrobial agents in development in the US and Europe. Prior to co-founding Qpex, he was Chief Scientific Officer and co-founder of Rempex Pharmaceuticals that was acquired by the Medicines Company (MDCO) in 2013, where he remained as the co-leader of the Infectious Disease Business Unit of MDCO. Prior to Rempex, he held VP/SVP/CSO positions of increasing responsibility at the biotech companies Mpex Pharmaceuticals (acquired by Aptalis in 2011), Diversa Corporation, and Microcide Pharmaceuticals. Prior to his career in pharmaceutical industry, he held full-time academic appointments that included Professor of Pharmacy and Chairman of the Department of Pharmacy Practice at the University of Rhode Island College of Pharmacy (URI), and Adjunct Professor of Medicine, Brown University School of Medicine at Roger Williams Medical Center in Providence, RI. As an academic researcher, he conducted preclinical and clinical research in antibacterial, antifungal, and antiviral agents, including pioneering work on PK-PD approaches for several classes of antiinfectives. Dr. Dudley has published over 130 scientific papers and book chapters describing the evaluation and clinical use of antiinfective agents and treatment of infectious diseases. He has served as an invited speaker at several FDA and EMA workshops, international meetings on infectious diseases, and advisor to several companies. He has served as an Editor for the journal Antimicrobial Agents and Chemotherapy and numerous other editorial and advisory boards. He completed undergraduate work at Pepperdine University and his Doctor of Pharmacy (PharmD) from the University of California San Francisco (UCSF), completed at residency at UCSF, and a fellowship in infectious diseases at Hartford Hospital.

Amplyx Announces Presentations on APX001 at American Society for Microbiology Microbe 2018 and the 20th Symposium on Infections in the Immunocompromised Host

René Russo, PharmD, BCPS

René Russo, PharmD, BCPS

Roger J. Pomerantz, M.D., F.A.C.P.

Christine Ann Miller

Graham G. Lumsden

Marco Taglietti, M.D.

Ankit Mahadevia

Jeffrey Stein, Ph.D.

Evan Loh, M.D.

Michael Dunne, M.D

Ciara Kennedy, Ph.D.

Ted Schroeder

Kevin Finney

Manos Perros, Ph.D.

David Roblin

Stephen Conafay

Christopher J. Burns, Ph.D.

Michael N. Dudley, Pharm.D.

Ramani Varanasi

Corey Fishman

Felix Faupel

Adrian Nivoliez