AmpliPhi Biosciences Reports Fourth Quarter and Full Year 2017 Financial Results and Business Highlights

“I’m delighted to report that AmpliPhi made progress in the fourth quarter and into 2018,” said Paul C. Grint, M.D., CEO of AmpliPhi Biosciences. “The highlight of the period was the announcement of positive topline results from our expanded access program to treat severely ill patients with AB-SA01 or AB-PA01, our bacteriophage therapeutic candidates targeting resistant Staphylococcus aureus and Pseudomonas aeruginosa infections. Expansion of this innovative and potentially life-saving program continues, as evidenced by the collaboration agreement we recently signed with the U.S. Department of Veterans Affairs. Our plan remains to bring the data to the FDA in mid-2018, obtain feedback on the path to regulatory approval, and potentially initiate a Phase 2 or registrational clinical study as early as the second half of 2018.”

Recent Business Highlights

• Announced positive topline results for the first seven patients treated under ongoing single-patient expanded access program. Six of the seven patients (86%) achieved treatment success (physician’s assessment), defined as complete resolution or significant improvement of baseline signs and symptoms. All patients were severely ill with life-threatening infections and unresponsive to antibiotics at the time of treatment.
• Provided a corporate update during an investor conference call on January 3, 2018, outlining the company’s 2018 clinical strategy and the various approaches the company is taking to fund Phase 2 clinical development of its bacteriophage therapeutics.
• Completed a public offering of 4,000,000 shares of common stock in January 2018, at a price to the public of $1.00 per share, for gross proceeds of $4.0 million.
• Signed a Cooperative Research and Development Agreement (CRADA) with the U.S. Department of Veterans Affairs covering expanded access treatment for AB-SA01 and AB-PA01. Mark Holodniy, M.D., Professor of Medicine (infectious diseases) at Stanford University and the Veterans Affairs Palo Alto Health Care System and Director of the Public Health Surveillance for the Department of Veterans Affairs, will be the Principal Investigator leading the collaboration.

Fourth Quarter 2017 Financial Results

• Research and development (R&D) expenses for the fourth quarter of 2017 were $1.1 million compared to $0.8 million for the fourth quarter of 2016.
• General and administrative (G&A) expenses were $1.3 million for the fourth quarter of 2017 compared to $1.5 million for the fourth quarter of 2016. The decrease was primarily due to a decrease in non-cash stock-based compensation.

Full-Year 2017 Financial Results

• R&D expenses for 2017 were $2.9 million compared to $5.7 million for 2016. The decrease was due to lower professional and consulting fees and clinical expenses. R&D expenses were offset by $2.0 million in tax rebates from the Australian government for qualified R&D expenditures in 2017 compared to $0.9 million in 2016.
• G&A expenses for 2017 were $7.6 million compared to $8.4 million in 2016. The decrease was primarily attributable to decreases in non-cash stock-based compensation and other charges in 2017.
• Net cash used in operating activities for 2017 was $9.2 million compared to $10.6 million for 2016.
• Cash and cash equivalents as of December 31, 2017 totaled $5.1 million.
• As of March 14, 2018, there were 13.7 million shares of common stock outstanding.
• The audit opinion included in the company’s Annual Report on Form 10-K for the year ended December 31, 2017 contains a going concern explanatory paragraph. The company is exploring multiple financing options.