SOUTH SAN FRANCISCO, Calif., May 12, 2014 (GLOBE NEWSWIRE) -- Achaogen, Inc. (Nasdaq:AKAO), a clinical-stage biopharmaceutical company developing novel antibacterials to treat multi-drug resistant (MDR) gram-negative infections, today reported financial results for the quarter ended March 31, 2014.
The quarter was highlighted by the initiation of a pivotal Phase 3 trial for plazomicin, Achaogen's lead product for the treatment of serious bacterial infections due to MDR Enterobacteriaceae, including carbapenem-resistant Enterobacteriaceae (CRE). This is a pathogen-specific trial that will enroll patients with a high risk of mortality and, if successful, provide clinical evidence of the superiority of plazomicin versus colistin for life-threatening bloodstream infections and pneumonia due to CRE. Top-line data from this trial are expected in the first half of 2017, with interim analyses projected to occur in 2015 and 2016.
Additionally, Achaogen successfully completed its initial public offering, receiving net proceeds of approximately $73.9 million, after deducting underwriting discounts, commissions and estimated offering expenses, and bolstered its leadership team with a number of recent appointments. John Smither and Dr. Chris Boerner joined its Board of Directors and Derek Bertocci joined as Chief Financial Officer. Mr. Smither currently serves as Chief Financial Officer of KYTHERA Biopharmaceuticals, a publicly-traded biotech company focused on the aesthetic market, and brings nearly 15 years of experience across financial roles at publicly-traded, commercial and late-stage clinical companies. Dr. Boerner currently serves as Executive Vice President, Commercial for Seattle Genetics, Inc., a publicly traded biotechnology company focused on the development and commercialization of innovative antibody-based therapies for the treatment of cancer. Mr. Bertocci brings significant financial and accounting experience to Achaogen having served as Chief Financial Officer to several publicly-traded life science and medical products companies.
"The first quarter proved to be a key period for Achaogen as we initiated our pivotal Phase 3 trial of plazomicin and we became a public company," commented Kenneth Hillan, Achaogen's Chief Executive Officer. "We are excited to embark on this new chapter in our growth trajectory as we strive to become a leading anti-infective company."
Summary Financial Results
Cash and cash equivalents totaled $84.9 million at March 31, 2014 compared to $10.7 million at December 31, 2013, increasing as a result of the funds raised through Achaogen's successful initial public offering.
Revenue totaled $6.0 million for the first quarter of 2014 compared to $3.5 million for the first quarter of 2013. Achaogen derived all of its revenue from funding provided under U.S. government contracts in connection with the development of product candidates. Research and development (R&D) expenses totaled $6.6 million for the first quarter of 2014 compared to $4.7 million for the first quarter of 2013. Revenue and R&D expenses both increased due to the initiation of Achaogen's Phase 3 trial of plazomicin during the first quarter of 2014.
General and administrative expenses totaled $2.6 million for the first quarter of 2014 compared to $2.1 million for the first quarter of 2013. The increase in general and administrative expenses was primarily due to additional costs associated with being a public company.
Net loss totaled $3.5 million for the first quarter of 2014 compared to a net loss of $3.8 million for the first quarter of 2013.
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 CRE. Through the Special Protocol Assessment procedure, the U.S. Food and Drug Administration has agreed that the design and planned analyses of Achaogen's single pivotal Phase 3 trial adequately address objectives in support of a New Drug Application. 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.
Forward Looking Statements
This press release contains forward-looking statements. All statements other than statements of historical facts contained in this press release 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 Achaogen's expectations regarding the enrollment and success of its Phase 3 trial for plazomicin, the trial's ability to show superiority of plazomicin versus colistin, the timing of interim analyses and receipt of top-line data, Achaogen's ability to become a leading anti-infective company, and Achaogen's ability to discover, develop and commercialize novel antibacterials to treat MDR gram-negative infections. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that may cause our 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 Phase 3 trial of plazomicin, 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; Achaogen's dependence on ARK Diagnostics, Inc. to develop and manufacture the IVD assay for 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 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 Form 10-Q for the fiscal quarter ended March 31, 2014, filed with the Securities and Exchange Commission on May 12, 2014. 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, Inc. | ||
| Condensed Consolidated Statements of Operations and Comprehensive Loss | ||
| (in thousands except share and per share data) | ||
| (Unaudited) | ||
| Three Months Ended March 31, | ||
| 2014 | 2013 | |
| Contract revenue | $ 5,988 | $ 3,533 |
| Operating expenses: | ||
| Research and development | 6,605 | 4,661 |
| General and administrative | 2,617 | 2,154 |
| Total operating expenses | 9,222 | 6,815 |
| Loss from operations | (3,234) | (3,282) |
| Interest expense and other, net | (221) | (525) |
| Interest income and other, net | -- | 54 |
| Net loss and comprehensive loss | $ (3,455) | $ (3,753) |
| Basic and diluted net loss per common share | $ (1.00) | $ (10.00) |
| Weighted-average common shares outstanding used to calculate basic and diluted net loss per common share | 3,456,088 | 375,321 |
| Achaogen, Inc. | ||
| Condensed Consolidated Balance Sheets | ||
| (in thousands) | ||
| March 31, | December 31, | |
| 2014 | 2013 | |
| (Unaudited) | ||
| Assets | ||
| Current assets: | ||
| Cash and cash equivalents | $ 84,937 | $ 10,738 |
| Contract and grants receivables | 6,027 | 7,230 |
| Prepaids and other current assets | 161 | 1,873 |
| Total current assets | 91,125 | 19,841 |
| Property and equipment, net | 662 | 743 |
| Restricted cash | 127 | 127 |
| Deposit and other assets | 44 | 47 |
| Total assets | $ 91,958 | $ 20,758 |
| Liabilities, convertible preferred stock, and stockholders' equity (deficit) | ||
| Current liabilities: | ||
| Accounts payable | $ 4,544 | $ 2,923 |
| Accrued liabilities | 2,832 | 3,004 |
| Notes payable, current portion | 5,540 | 4,989 |
| Other current liabilities | 64 | 73 |
| Total current liabilities | 12,980 | 10,989 |
| Deferred rent | 133 | 125 |
| Notes payable, net of current portion | -- | 1,698 |
| Other long-term liability | -- | 244 |
| Total liabilities | 13,113 | 13,056 |
| Convertible preferred stock | -- | 132,278 |
| Stockholders' equity (deficit) | 78,845 | (124,576) |
| Total liabilities, convertible preferred stock, and stockholders' equity (deficit) | $ 91,958 | $ 20,758 |