Achaogen
Aug 3, 2017

Achaogen Reports Second Quarter 2017 Financial Results and Provides Corporate Update

-- Plazomicin granted Breakthrough Therapy designation --

-- C-Scape Phase 1 study underway to evaluate orally-administered antibacterial candidate for infections due to ESBL-producing Enterobacteriaceae --

-- Conference call today at 4:30 p.m. Eastern Time --

SOUTH SAN FRANCISCO, Calif., Aug. 03, 2017 (GLOBE NEWSWIRE) -- Achaogen, Inc. (NASDAQ:AKAO), a late-stage biopharmaceutical company discovering and developing innovative antibacterials addressing multi-drug resistant (MDR) gram-negative infections, today reported financial results for the second quarter 2017, and provided an update on its corporate and clinical development activities.

"We made excellent progress this quarter including being granted FDA Breakthrough Therapy designation for plazomicin, securing more than a dozen plazomicin presentations at ASM Microbe, and dosing the first patient in our C-Scape clinical development program," said Kenneth Hillan, M.B. Ch.B., Achaogen's Chief Executive Officer. "Our planned plazomicin NDA application is our top priority and we remain on track to file the NDA in 2017."

Recent Highlights and Upcoming Milestones

Plazomicin has successfully completed two Phase 3 clinical trials and the Company continues to plan to submit a New Drug Application (NDA) to the Food and Drug Administration (FDA) in the second half of 2017 and to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in 2018. The EPIC (Evaluating Plazomicin IcUTI) trial is expected to serve as a single registration trial supporting an NDA for plazomicin in the United States and an MAA in the European Union. The second study, the Phase 3 CARE (Combating Antibiotic Resistant Enterobacteriaceae) trial was a resistant pathogen trial designed to evaluate the efficacy and safety of plazomicin in patients with serious bacterial infections due to carbapenem-resistant Enterobacteriaceae (CRE) and provides additional data supporting the NDA and plazomicin therapy in these patients.

C-Scape is an orally-available antibacterial candidate that is a combination of an approved beta-lactam and an approved beta-lactamase inhibitor, with the potential to treat patients with cUTI due to MDR pathogens such as extended spectrum beta-lactamase (ESBL)-producing Escherichia coli and Klebsiella pneumoniae.

Other Corporate Highlights

Second Quarter 2017 Financial Results

Cash, cash equivalents and short-term investments totaled $230.3 million, and restricted cash totaled $12.6 million at June 30, 2017.  

Contract revenue totaled $1.3 million for the second quarter of 2017 compared to $9.1 million for the same period of 2016. The decrease in contract revenue during the quarter was primarily due to full utilization of BARDA funding available under the current contract.

Research and development (R&D) expenses were $22.2 million for the second quarter of 2017 compared to $21.7 million reported for the same period in 2016. The increase in R&D expenses during the quarter was attributable to increase in personnel and facility related costs as net headcount increase in our research and development organization, increase of external expenses related to C-Scape clinical program, offset by decreases related to the plazomicin clinical and other research programs.

General and Administrative (G&A) expenses were $8.9 million for the second quarter of 2017 compared to $4.0 million for the same period in 2016. The increase in G&A expenses during the quarter was primarily attributable to increase in personnel and facility related costs, and in costs related to preparation for the commercialization of plazomicin.

Net loss for the second quarter of 2017 was $26.1 million compared to net loss of $18.3 million for the second quarter of 2016. Diluted net loss per share were $0.78 in the second quarter of 2017, compared to diluted net loss per share of $0.87 in the second quarter of 2016.

As of June 30, 2017, there were approximately 42.2 million shares of common stock outstanding.

Conference Call
The Company will host a conference call today, August 3, 2017 at 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time. To participate by telephone, please dial 888-262-8942 (Domestic) or 719-325-2491 (International). The conference ID number is 5142531. 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.

About Achaogen
Achaogen is a late-stage biopharmaceutical company passionately committed to the discovery, development, and commercialization of innovative 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 (BARDA), 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 an orally-available antibacterial candidate, C-Scape, a combination of an approved beta-lactam and an approved beta-lactamase inhibitor. Achaogen is also pursuing an advanced series of LpxC inhibitor compounds that are active against Pseudomonas aeruginosa, and have been funded in part with Federal funds from the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, Department of Health and Human Services, under Contract No. HHSN272201500009C. The LpxC inhibitor program will be funded in part with funds from Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X). All product candidates are investigational only and have not been approved for commercialization. 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 potential regulatory approval of plazomicin, Achaogen's commercial objectives and Achaogen's pipeline of product candidates. 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 when bacteria will evolve resistance to plazomicin; 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; risks and uncertainties related to government or grant funding for certain of Achaogen's programs, including the risk that such funding could terminate and impact development programs; 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, 2016 and its Quarterly Report on Form 10-Q for the quarter ended March 31, 2017. 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.

Source: Achaogen, Inc. (NASDAQ: AKAO)

 
Achaogen, Inc.
Condensed Consolidated Statements of Operations
(in thousands except share and per share data)
(unaudited)
        
 Three Months Ended Six Months Ended
 June 30, June 30,
  2017   2016   2017   2016 
Contract revenue$1,266  $9,144  $8,729  $14,993 
Operating expenses:       
Research and development 22,199   21,708   40,797   35,601 
General and administrative 8,860   3,951   15,609   7,728 
Total operating expenses 31,059   25,659   56,406   43,329 
        
Loss from operations (29,793)   (16,515)   (47,677)   (28,336) 
        
Interest expense (723)   (447)   (1,430)   (885) 
Change in warrant and derivative liabilities 4,225   (1,382)   (10,731)   (1,382) 
Other income, net 221   76   510   138 
Net loss$(26,070)  $(18,268)  $(59,328)  $(30,465) 
Net loss per common share:       
Basic$(0.68)  $(0.87)  $(1.61)  $(1.55) 
Diluted$(0.78)  $(0.87)  $(1.61)  $(1.55) 
Weighted-average common shares used to calculate net loss per common share       
       
Basic 38,072,763   20,899,297   36,905,802   19,648,792 
Diluted 39,092,279   20,899,297   36,905,802   19,648,792 
                


 Achaogen, Inc. 
 Condensed Consolidated Balance Sheets 
 (in thousands) 
      
  June 30, December 31, 
   2017  2016 
  (unaudited)   
 Assets    
 Current assets:    
 Cash and cash equivalents$143,999 $118,964 
 Short-term investments 86,295  26,912 
 Contracts receivable 1,117  12,151 
 Prepaids and other current assets 7,810  2,189 
 Restricted cash 8,991  127 
 Total current assets 248,212  160,343 
 Property and equipment, net 11,415  3,261 
 Restricted cash 3,575  250 
 Deposit and other assets -  71 
 Total assets$263,202 $163,925 
      
 Liabilities, contingently redeemable common stock and stockholders' equity    
 Current liabilities:    
 Accounts payable$7,850 $5,739 
 Accrued liabilities 8,385  9,698 
 Loan payable, current portion 10,417  4,167 
 Deferred revenue 2,968  - 
 Other current liabilities 28  104 
 Total current liabilities 29,648  19,708 
      
 Loan payable, long-term 15,280  21,110 
 Warrant liability 23,043  13,874 
 Derivative liability 642  602 
 Deferred Rent 6,076  1,896 
 Total liabilities 74,689  57,190 
      
 Contingently redeemable common stock 10,000  - 
 Stockholders' equity 178,513  106,735 
 Total liabilities, contingently redeemable common stock and stockholders' equity$263,202 $163,925 
        

Investor Contact:
Matthew Duffy
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matthew@lifesciadvisors.com

Media Contact:
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