Press Release
Akebia Announces Third Quarter 2014 Financial Results
-Advancing Toward Global Phase 3 Registration Studies in 2015 Following Positive Top-Line Results from Phase 2b Study of AKB-6548-
"In recent months, we have made substantial progress with our
development program for AKB-6548 in renal anemia, most significantly,
reporting positive top-line data from our Phase 2b study in non-dialysis
patients with chronic kidney disease, or CKD. This result provides a
clear path forward into Phase 3 registration studies next year," stated
Third Quarter and Recent Corporate Highlights
- Announced positive top-line results from its Phase 2b study of AKB-6548 in non-dialysis patients with anemia related to chronic kidney disease
- Initiated Phase 2 development of AKB-6548 for the treatment of anemia in patients undergoing dialysis, with results expected in the third quarter of 2015
-
Strengthened the Board of Directors with the addition of Ronald C.
Renaud , Jr., former President and Chief Executive Officer ofIdenix Pharmaceuticals, Inc. - Completed a thorough QT (TQT) study demonstrating that AKB-6548 does not have an adverse effect on cardiac repolarization or conduction
Third Quarter 2014 Financial Results
Akebia reported a net loss and a net loss applicable to common
stockholders of
Research and development expenses were
General and administrative expenses were
The increased stock-based compensation expense in both research and development expenses and general and administrative expenses is primarily a result of an increase in the value of the Company's common stock due to the Company's initial public offering.
The Company's cash used in operations during the third quarter of 2014
was
About Akebia Therapeutics
Forward-Looking Statements
This press release includes forward-looking statements. Such
forward-looking statements include those about Akebia's strategy, future
plans and prospects, including statements regarding the potential
indications and benefits of AKB-6548, the development plan for the Phase
2 study in dialysis patients with anemia related to CKD, the development
plan for Phase 3 including discussions with regulatory authorities, and
the potential of AKB-6548 to be a "best-in-class" product. The words
"anticipate," "appear," "believe," "estimate," "expect," "intend,"
"may," "plan," "predict," "project," "target," "potential," "will,"
"would," "could," "should," "continue," and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Each
forward-looking statement is subject to risks and uncertainties that
could cause actual results to differ materially from those expressed or
implied in such statement, including the risk that existing preclinical
and clinical data may not be predictive of the results of ongoing or
later clinical trials; the ability of Akebia to successfully complete
the clinical development of AKB-6548; the funding required to develop
Akebia's product candidates and operate the company, and the actual
expenses associated therewith; the timing and content of decisions made
by the FDA and other regulatory authorities; the rate of enrollment in
the Phase 2 study; the actual time it takes to complete the Phase 2
study and analyze the data; the success of competitors in developing
product candidates for diseases for which Akebia is currently developing
its product candidates; and Akebia's ability to obtain, maintain and
enforce patent and other intellectual property protection for AKB-6548.
Other risks and uncertainties include those identified under the heading
"Risk Factors" in Akebia's Quarterly Report on Form 10-Q for the quarter
ended
Tables Follow:
|
||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
|
|
|
|
|
||||||||||||
Revenue | $ |
— |
$ |
— |
$ |
— |
$ |
— |
||||||||
Operating expenses: | ||||||||||||||||
Research and development | 6,648 | 3,240 | 18,330 | 7,591 | ||||||||||||
General and administrative | 2,936 | 794 | 9,003 | 2,141 | ||||||||||||
Total operating expenses | 9,584 | 4,034 | 27,333 | 9,732 | ||||||||||||
Operating loss | (9,584 | ) | (4,034 | ) | (27,333 | ) | (9,732 | ) | ||||||||
Other income, net | 236 | 266 | 669 | 2,513 | ||||||||||||
Net loss and comprehensive loss | $ | (9,348 | ) | $ | (3,768 | ) | $ | (26,664 | ) |
$ |
(7,219 | ) | ||||
Reconciliation of net loss to net loss applicable to common stockholders:
|
||||||||||||||||
Net loss | $ | (9,348 | ) | $ | (3,768 | ) | $ | (26,664 | ) | $ | (7,219 | ) | ||||
Accretion on preferred stock | (2,748 | ) | (86,899 | ) | (52,862 | ) | ||||||||||
Loss on extinguishment of preferred stock |
— |
|
— |
— |
— |
|||||||||||
Net loss applicable to common stockholders | $ | (9,348 | ) | $ | (6,516 | ) | $ | (113,563 | ) | $ | (60,081 | ) | ||||
Net loss per share applicable to common stockholders— basic and diluted
|
$ | (0.47 | ) | $ | (11.92 | ) | $ | (8.16 | ) | $ | (117.94 | ) | ||||
Weighted-average number of common shares used in net loss per share applicable to common stockholders— basic and diluted
|
19,691,167 | 546,714 | 13,920,651 | 509,425 | ||||||||||||
Selected Balance Sheet Data (in thousands) (unaudited) |
||||||||||
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|
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Cash, cash equivalents and short-term investments | $ | 118,338 | $ | 32,556 | ||||||
Working capital | 113,318 | 29,529 | ||||||||
Total assets | 120,170 | 34,665 | ||||||||
Total stockholders' equity (deficit) | 113,614 | (127,072 | ) | |||||||
Investors:
Senior Director, Investor Relations and Corporate
Communications
njones@akebia.com
or
Media:
liz.falcone@fkhealth.com
Source:
News Provided by Acquire Media
Akebia Therapeutics, Inc.
245 First Street, Suite 1400
Cambridge, MA 02142
+1 617.871.2098 phone
+1 617.871.2099 fax