Achaogen Awarded $2.4 Million Contract Option by NIAID to Support Development of LpxC Inhibitors for the Treatment of Serious Bacterial Infections

Funding Focused on Novel Small Molecules with an Antibacterial Mechanism Distinct from Currently Available Antibiotics


SOUTH SAN FRANCISCO, Calif., April 21, 2016 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today announced that it has been awarded an additional $2.4 million under an existing contract with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services.

The award will fund the continued research and development of Achaogen’s LpxC inhibitors, which are novel small molecule agents for the potential treatment of bacterial infections, including those resistant to currently available antibiotics. NIAID funding for the LpxC inhibitor research program now totals $4.4 million and, should the remaining contract option be exercised, the total award would reach $5 million.

“This additional support reflects NIAID's ongoing commitment to advance the development of novel drugs to potentially treat multi-drug resistant gram-negative infections,” said Kenneth Hillan, M.B. Ch.B., Achaogen's Chief Executive Officer. “We are excited to continue development of our LpxC inhibitor antibiotic drug candidates with the crucial support of NIAID whose contribution to this effort is helping to advance what may be the first new mechanism against gram-negative infections in over forty years.”

Achaogen is pursuing an advanced series of LpxC inhibitor compounds that are active against Pseudomonas aeruginosa, a common gram-negative pathogen associated with serious illnesses. LpxC is an essential enzyme for the formation of bacterial membranes in gram-negative bacteria that is highly conserved among gram-negative species. The Company has a goal of nominating a clinical candidate from its LpxC inhibitor research program in 2016 and filing an Investigational New Drug (IND) application in 2017.

About the LpxC Inhibitors
LpxC inhibitors have the potential to fill an important unmet medical need in the treatment of gram-negative bacterial infections, and additionally have the potential to treat infections caused by biothreat pathogens. LpxC inhibition would represent the first new mode of action in over forty years for the treatment of antibiotic-resistant gram-negative bacterial infections. Achaogen's LpxC inhibitor program is currently in the preclinical stage of development. As the program continues with contract funding from NIAID, the Company will apply the significant knowledge it has gained from research and clinical studies of LpxC inhibitors.

About NIAID and NIH
The National Institute of Allergy and Infectious Diseases (NIAID) conducts and supports research - at the National Institutes of Health (NIH), throughout the United States, and worldwide - to study the causes of infectious and immune-mediated diseases, and to develop better means of preventing, diagnosing and treating these illnesses. News releases, fact sheets and other NIAID-related materials are available on the NIAID Web site at http://www.niaid.nih.gov.

The NIH - The Nation's Medical Research Agency - includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. It is the primary federal agency for conducting and supporting basic, clinical and translational medical research, and it investigates the causes, treatments and cures for both common and rare diseases. For more information about NIH and its programs, visit http://www.nih.gov.

About Achaogen
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 LpxC inhibitors for the treatment of serious bacterial infections including MDR gram-negative bacteria. In addition to its work developing plazomicin, Achaogen is researching and developing other treatments for bacterial infections, including LpxC inhibitors. 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, and Achaogen has other programs in clinical, and early and late preclinical stages focused on other MDR gram-negative infections. For more information, please visit www.achaogen.com.

Forward-Looking Statements

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 use of funds from the funds from Option 1 under the Company’s agreement with NIAID, (ii) whether Achaogen’s may develop the first new mechanism against gram-negative infections in over forty years, (iii) Achaogen’s goal of nominating a clinical candidate from its LpxC inhibitor research program in 2016 and to file an IND application in 2017 and (iv) the potential for LpxC inhibitors to fill an important unmet medical need in the treatment of gram-negative bacterial infections, and to treat infections caused by biothreat pathogens. 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; 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 an LpxC inhibitor; risks and uncertainties as to Achaogen's ability to raise additional capital to support the development of LpxC inhibitors 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 National Institute of Allergy and Infectious Diseases (NIAID) could terminate Achaogen's contract for the funding of the LpxC inhibitor 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2015. 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.

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