-- Accelerated Timeline for Reporting Top-Line Results from Phase 3 EPIC Registration Clinical Trial of Plazomicin; Top-Line Data in First Quarter of 2017 and NDA Submission in Second Half of 2017 --
-- Awarded $2.4M Contract Option by NIAID to Support Development of Medicines to Treat Serious Bacterial Infections --
SOUTH SAN FRANCISCO, Calif., May 05, 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 first quarter 2016, and reviewed recent corporate and clinical development progress.
"During the first quarter of 2016, we executed on several key milestones including, most recently, being awarded additional funding from NIAID for the research and development of our LpxC inhibitors, which are novel small molecule agents for the potential treatment of bacterial infections," said Kenneth Hillan, Achaogen's Chief Executive Officer. “We expect 2016 to be a year of considerable progress and, due to the acceleration of the timeline for the EPIC study, we look forward to completing enrollment in the EPIC study in 2016 and reporting top-line results in the first quarter of 2017."
Plazomicin – The Company’s lead product candidate is being developed to treat serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE), and is currently being evaluated in two Phase 3 clinical trials. The EPIC (Evaluating plazomicin in cUTI) study is expected to serve as a single pivotal trial supporting a New Drug Application (NDA) for plazomicin in the United States.
- Announced the acceleration of the expected timeline for reporting results from the Phase 3 EPIC registration clinical trial of plazomicin due to more rapid enrollment than anticipated; the Company expects to release top-line results from the EPIC study in the first quarter of 2017 and plans to submit an NDA to the U.S. Food and Drug Administration (FDA) in the second half of 2017.
- Continued to enroll patients in the CARE (Combating Antibiotic Resistant Enterobacteriaceae) study, a Phase 3 clinical trial in patients with serious bacterial infections due to CRE. The Company expects to announce top-line results from the CARE study in the first half of 2017.
Pseudomonas and Acinetobacter Discovery and Development Programs – Beyond the Company’s plazomicin program, the research and early development teams are focused on discovering and developing novel medicines for serious infections caused by MDR pathogens including Acinetobacter baumannii and Pseudomonas aeruginosa. The Company’s goal is to file an Investigational New Drug (IND) application from its research programs in 2017.
- LpxC inhibitors: Received $2.4 million for an additional option under an existing contract with the National Institute of Allergy and Infectious Diseases (NIAID). The Company is pursuing an advanced series of compounds that are active against Pseudomonas aeruginosa, with an antibacterial mechanism distinct from currently available antibiotics, supported by up to $5 million in funding from NIAID.
First Quarter 2016 Financial Results
Unrestricted cash, cash equivalents and short-term investments totaled $49.5 million at March 31, 2016 compared to $58.7 million at December 31, 2015.
Contract revenue totaled $5.8 million for the first quarter of 2016 compared to $4.9 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 with the Biomedical Advanced Research and Development Authority (BARDA) and the LpxC inhibitor contract with NIAID. 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 $13.9 million for the first quarter of 2016 compared to $7.9 million reported for the same period in 2015. The increase in research and development expenses primarily relates to increased program costs associated with the Phase 3 EPIC study, higher personnel-related expenses, as well as increased costs related to non-plazomicin research programs.
General and administrative expenses were $3.8 million for first quarter of 2016 compared to $3.2 million for the same period in 2015. The increase in general and administrative expenses primarily relates to higher personnel-related expenses and professional fees.
Net loss for the first quarter of 2016 was $12.2 million, or $0.66 per share, compared to a net loss of $6.2 million, or $0.34 per share, for the first quarter of 2015.
Total shares outstanding at March 31, 2016, were approximately 18.4 million common shares.
This press release contains forward-looking statements. All statements other than statements of historical facts contained herein are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Achaogen’s expectations regarding (i) the enrollment and success of Achaogen’s ongoing Phase 3 EPIC trial and Phase 3 CARE trial, (ii) the expectation that the Phase 3 EPIC trial will serve as a single pivotal trial supporting an NDA for plazomicin, (iii) the timing for completion of Achaogen’s Phase 3 trials and submission of an NDA to the FDA, and (iv) the goal to file an IND application from its research programs in 2017. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause Achaogen's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the preclinical and clinical development process; specific risks related to the ongoing Phase 3 EPIC trial and Phase 3 CARE trial, including the lack of a prior clinical trial in patients with CRE infections and challenges in enrolling an adequate number of patients with rare infections; the risk of failure to successfully validate, develop and obtain regulatory clearance or approval for the in vitro diagnostic (IVD) assay for plazomicin; the risks and uncertainties of the regulatory approval process; the risks and uncertainties of commercialization and gaining market acceptance; the risk that bacteria may evolve resistance to plazomicin; risks and uncertainties as to Achaogen's ability to raise additional capital to support the development of plazomicin and its other programs; uncertainties regarding the availability of adequate third-party coverage and reimbursement for newly approved products; Achaogen's reliance on third parties to conduct certain preclinical studies and all of its clinical trials; Achaogen's reliance on third-party contract manufacturing organizations to manufacture and supply its product candidates and certain raw materials used in the production thereof; Achaogen's dependence on its President and Chief Executive Officer; risks and uncertainties related to the acceptance of government funding for certain of Achaogen's programs, including the risk that BARDA could terminate Achaogen's contract for the funding of the plazomicin development program; risk of third party claims alleging infringement of patents and proprietary rights or seeking to invalidate Achaogen's patents or proprietary rights; and the risk that Achaogen's proprietary rights may be insufficient to protect its technologies and product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Achaogen's business in general, see Achaogen's current and future reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2016. Achaogen does not plan to publicly update or revise any forward-looking statements contained in this press release, whether as a result of any new information, future events, changed circumstances or otherwise.
Achaogen is a clinical-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of novel antibacterials to treat MDR gram-negative infections. Achaogen is developing plazomicin, Achaogen’s lead product candidate, for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae. Achaogen’s plazomicin program is funded in part with Federal funds from the Biomedical Advanced Research and Development Authority, Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, under Contract No. HHSO100201000046C. Plazomicin is the first clinical candidate from Achaogen’s gram-negative antibiotic discovery engine. Achaogen has other programs in early and late preclinical stages focused on other MDR gram-negative infections, including LpxC inhibitors for the treatment of serious bacterial infections including MDR gram-negative bacteria. Achaogen's LpxC inhibitor program has been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500009C. LpxC inhibitors are the second class of molecules from Achaogen's gram-negative antibiotic discovery engine. For more information, please visit www.achaogen.com.
|Condensed Consolidated Statements of Operations|
|(in thousands except share and per share data)|
|Three Months Ended March 31,|
|Research and development||13,893||7,879|
|General and administrative||3,777||3,231|
|Total operating expenses||17,670||11,110|
|Loss from operations||(11,821||)||(6,230||)|
|Other income, net||62||51|
|Basic and diluted net loss per common share||$||(0.66||)||$||(0.34||)|
|Weighted-average common shares outstanding used to|
|calculate basic and diluted net loss per common share||18,398,228||17,998,390|
|Condensed Consolidated Balance Sheets|
|March 31,||December 31,|
|Cash and cash equivalents||$||19,432||$||20,287|
|Prepaids and other current assets||3,381||1,719|
|Total current assets||57,938||65,489|
|Property and equipment, net||1,053||905|
|Deposit and other assets||70||342|
|Liabilities and stockholders’ equity|
|Loan payable, current portion||500||-|
|Other current liabilities||233||225|
|Total current liabilities||12,741||8,689|
|Loan payable, long-term||14,171||14,536|
|Other long-term liabilities||432||479|
|Total liabilities and stockholders’ equity||$||59,188||$||66,863|