(AKAO) $20M Contract, $25M Private Placement, 50 Pct. Enrollment Phase 3 EPIC Trial

Option Funding Focused on Phase 3 EPIC Registration Trial of Plazomicin in cUTI; Company Expects Top-Line EPIC Study Results in the First Quarter of 2017

SOUTH SAN FRANCISCO, Calif., June 02, 2016 — 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 $20 million for an additional option, Option 3, on its existing contract with the Biomedical Advanced Research and Development Authority (BARDA) to support the development of plazomicin. Plazomicin is the Company’s lead product candidate being developed to treat serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE).

The BARDA contract was originally awarded to Achaogen under BARDA’s Broad Spectrum Antimicrobials program in August 2010. The original contract consisted of a base award as well as three options that, effective today, have all been exercised. With the granting of this last option, the unspent funding currently committed under the contract with BARDA now totals approximately $41 million. The funding from Option 3 is focused on the Phase 3 pivotal clinical trial of plazomicin, the EPIC study, in complicated urinary tract infections (cUTI). Achaogen expects to release top-line results from the EPIC study in the first quarter of 2017, and plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in the second half of 2017.

“We appreciate BARDA’s overall support of the plazomicin program, including this additional financial support for the Phase 3 EPIC study,” said Kenneth Hillan, M.B. Ch.B., Achaogen’s Chief Executive Officer. “Multi-drug resistant gram-negative infections continue to be a serious public health threat, especially given the high mortality rates associated with CRE infections.”

In a separate press release, the Company announced today that it has entered into an agreement to sell shares of its common stock and warrants to purchase shares of common stock for aggregate gross proceeds of approximately $25 million in a private placement to a syndicate of new investors. In addition to this equity financing, the Company plans to draw $10 million in additional debt under its existing loan agreement with Solar Capital Ltd.

About the EPIC Study
EPIC (Evaluating plazomicin in cUTI) is a multi-national, randomized, controlled, double-blind clinical trial in patients with complicated urinary tract infections (cUTI) including acute pyelonephritis (AP), which is expected to create a substantial opportunity for plazomicin to address unmet medical needs arising from multi-drug resistant (MDR) infections. EPIC is expected to serve as a single pivotal trial supporting a New Drug Application (NDA) for plazomicin in the United States.

Proceeds to Support Advancement of Development Programs Addressing Multi-Drug Resistant Gram-Negative Infections

SOUTH SAN FRANCISCO, Calif., June 02, 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 entered into an agreement to sell shares of its common stock and warrants to purchase shares of its common stock for aggregate gross proceeds of approximately $25 million in a private placement. New Enterprise Associates (NEA), one of the largest biotechnology investors worldwide, led the placement and was joined by EcoR1 Capital, LLC and additional new investors. Achaogen expects to use proceeds of the financing to advance its research and development programs and for general corporate purposes. The Company’s lead product candidate, plazomicin, is being developed to treat serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE).

As a result of this equity financing, the Company expects to meet certain funding conditions under an existing loan agreement with Solar Capital Ltd. and plans to draw an additional $10 million term loan from Solar Capital.

In a separate press release, the Company also announced today that it has been awarded $20 million for an additional option, Option 3, on its existing contract with the Biomedical Advanced Research and Development Authority (BARDA) to support the development of plazomicin. The remaining available funding currently committed under the contract with BARDA now totals approximately $41 million.

“We welcome a distinguished group of new investors to Achaogen,” said Kenneth Hillan, M.B. Ch.B., Achaogen’s Chief Executive Officer. “We are excited to advance plazomicin to top-line data from the EPIC study in patients with cUTI and the CARE study in patients with serious bacterial infections due to CRE.”

About the Private Placement
Achaogen has agreed to sell approximately 8 million shares of common stock and warrants to purchase approximately 2 million shares of common stock for aggregate gross proceeds of approximately $25 million before deducting offering expenses. The price to be paid for the common stock, $3.15 per share, is equal to the consolidated closing bid price on the Nasdaq Global Market on the day of pricing, June 1, 2016. The warrants have a per share exercise price of $3.66, are exercisable immediately, and expire five years from the date of issuance.

The Company expects the offering to close by June 3 subject to satisfaction of specified customary closing conditions.

The securities to be sold in this private placement have not been registered under the Securities Act of 1933, as amended, or any state securities laws, and will be sold in a private placement pursuant to Regulation D of the Securities Act. The securities may not be offered or sold in the United States absent registration or pursuant to an exemption from the registration requirements of the Securities Act and applicable state securities laws. Achaogen has agreed to file a registration statement covering the resale of the shares of common stock acquired by the investors and shares of common stock issuable upon exercise of the warrants acquired by the investors.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

Company Expects Completion of Enrollment in Phase 3 EPIC Study in 2016, Top-Line Data in First Quarter of 2017 and NDA Submission in Second Half of 2017

SOUTH SAN FRANCISCO, Calif., June 02, 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 achieved over 50 percent patient enrollment in its ongoing Phase 3 EPIC registration clinical trial of plazomicin. Achaogen is developing plazomicin, its lead product candidate, to treat serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE).

“Enrollment in the EPIC clinical trial has been progressing well and we are pleased that we have enrolled half of the approximately 530 patients that we intend to recruit for the trial,” said Kenneth Hillan, Achaogen’s Chief Executive Officer. “We look forward to completing enrollment in the EPIC trial this year and expect to report top-line data in first quarter of 2017.”

EPIC (Evaluating plazomicin in cUTI) is a multi-national, randomized, controlled, double-blind clinical trial in patients with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP), which is expected to create a substantial opportunity for plazomicin to address the unmet medical need arising from multi-drug resistant (MDR) infections. The EPIC trial is expected to serve as a single pivotal trial and support a New Drug Application (NDA) submission in the second half of 2017. The Company also expects to announce top-line results for the CARE (Combating Antibiotic Resistant Enterobacteriaceae) study, a Phase 3 clinical trial in patients with serious bacterial infections due to CRE, in the first half of 2017.

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 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 a contract from the Biomedical Advanced Research and Development Authority. Plazomicin is the first clinical candidate from Achaogen’s gram-negative antibiotic discovery engine, and Achaogen has other programs in 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 timeline for enrollment 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, and (iii) the timing for completion of Achaogen’s Phase 3 trials and submission of an NDA to the U.S. Food and Drug Administration. 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 quarter ended March 31, 2016, and 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.

Investor Contact: 
Hans Vitzthum
212.915.2568
hans@lifesciadvisors.com

Media Contact: 
Denise Powell
510.703.9491
denise@redhousecomms.com