-- Completed Enrollment in Phase 3 Plazomicin Clinical Trials; Expect Results from EPIC and CARE Trials by End of 2016 --
-- Planning Plazomicin NDA Submission in the Second Half of 2017 --
-- Presented First Plazomicin CARE Trial Data in Patients with Carbapenem-Resistant Enterobacteriaceae (CRE) Infections at IDWeek™ 2016 --
-- Conference Call Today at 4:30 p.m. Eastern Time --
SOUTH SAN FRANCISCO, Calif., Nov. 07, 2016 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today reported financial results for the third quarter of 2016, and announced the acceleration of the expected timeline for reporting results from the Phase 3 clinical trials of its lead product candidate, plazomicin, which is being developed to treat serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE).
“Thanks to the coordinated efforts of our team and participating clinical trial sites, we were successful in completing enrollment of the Phase 3 EPIC trial ahead of schedule, and now expect to announce top-line EPIC and CARE results before the end of 2016,” said Kenneth Hillan, M.B. Ch.B., Achaogen’s Chief Executive Officer. “Also, at the recent IDWeek conference, we presented the first data from the CARE trial, which highlighted the role of therapeutic drug management in guiding targeted dosing of plazomicin in critically ill patients with antibiotic resistant gram-negative infections.”
Recent Highlights and Upcoming Milestones
Plazomicin is currently being evaluated in two Phase 3 clinical trials. The EPIC (Evaluating plazomicin in cUTI) trial is expected to serve as a single registration trial supporting a New Drug Application (NDA) for plazomicin in the United States and a Marketing Authorization Application (MAA) in the European Union. The CARE (Combating Antibiotic Resistant Enterobacteriaceae) trial is a supportive study in patients with serious bacterial infections due to CRE.
• Completed patient enrollment in both the Phase 3 EPIC registrational trial and ended enrollment in the supportive Phase 3 CARE trial;
• Accelerated the expected timeline for reporting top-line results from both Phase 3 clinical trials of plazomicin. The Company now expects to report top-line results from both the EPIC and CARE clinical trials by the end of 2016 and continues to plan to submit an NDA to the U.S. Food and Drug Administration (FDA) in the second half of 2017;
• Conducted a meeting with the U.K. Medicines & Healthcare products Regulatory Agency (MHRA) and their feedback confirmed that data from the plazomicin development program would support a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA). We plan to submit a MAA for plazomicin in 2018; and
• Presented the first data from the CARE trial at the Infectious Diseases Society of America (IDSA) IDWeek 2016 Annual Meeting outlining the contribution of therapeutic drug management (TDM) in achieving optimal dosing of plazomicin in critically ill patients and showing that plazomicin therapy was well tolerated in the first 10 patients enrolled in Cohort 2 of the CARE trial. Additionally, data against 2,306 clinical isolates collected from 30 U.S. hospitals as part of the 2015 plazomicin surveillance program confirmed the potent in vitro activity of plazomicin and that plazomicin was the most active aminoglycoside tested against CRE.
Third Quarter 2016 Financial Results
Unrestricted cash, cash equivalents and short-term investments totaled $61.1 million at September 30, 2016 compared to $58.7 million at December 31, 2015.
Contract revenue totaled $16.0 million for the third quarter of 2016 compared to $4.5 million for the same period of 2015. The increase in contract revenue during the quarter was primarily due to the increased research and development activities under the contract Option 3 with BARDA. Achaogen derived all of its revenue from funding provided under U.S. government contracts in connection with the research and development of product candidates.
Research and development expenses were $20.5 million for the third quarter of 2016 compared to $10.0 million reported for the same period in 2015. The increase in research and development expenses during the quarter primarily relates to increased program costs associated with the Phase 3 EPIC trial, higher personnel-related expenses, as well as increased costs related to non-plazomicin research programs.
General and Administrative (G&A) expenses were $4.5 million for the third quarter of 2016 compared to $3.0 million for the same period in 2015. The increase in G&A expenses during the quarter primarily relates to increased activity to support plazomicin development and manufacturing and to prepare for registration and commercialization.
Net other expenses were $1.4 million for the third quarter of 2016 compared to nil for the same period in 2015. The increase was primarily related to non-cash charges for the revaluation of warrants issued in the private placement of common stock and warrants to purchase common stock in June 2016.
Net loss for the third quarter of 2016 was $11.0 million, or $0.41 per share, compared to a net loss of $8.8 million, or $0.48 per share, for the third quarter of 2015.
As of September 30, 2016, there were approximately 27.5 million shares of common stock outstanding.
Conference Call
The Company will host a conference call today, November 7, 2016 at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time. To participate by telephone, please dial 877-857-6163 (Domestic) or 719-325-4879 (International). The conference ID number is 6858559. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.achaogen.com. The archived audio webcast will remain available on the Company’s website for 30 days following the conference call.
