Press Release
Akebia Announces Second Quarter 2014 Financial Results
-Company Remains on Track to Report Phase 2b Data for AKB-6548 in Fourth Quarter-
-Strengthens Management Team and Board-
"Over the past few months, we have advanced our efforts to deliver a
novel, best-in-class therapy that harnesses the power of HIF biology for
the treatment of anemia secondary to chronic kidney disease, a
significant and growing patient population that remains severely
under-treated," stated
Second Quarter and Recent Corporate Highlights
- In April, completed enrollment in the Phase 2b clinical study of AKB-6548 for the treatment of anemia associated with chronic kidney disease (CKD) in patients who are not dependent on dialysis
-
Expanded the senior management team, adding
Brad Maroni , M.D., as Senior Vice President and Chief Medical Officer,Mark De Rosch , Ph.D., as Vice President of Regulatory Affairs andTamara Dillon as Vice President of Human Resources -
Strengthened the Board of Directors with the addition of Michael D.
Clayman, M.D., Chief Executive Officer of Flexion Therapeutics, Inc.,
and
Maxine Gowen , Ph.D., President and Chief Executive Officer of Trevena, Inc. -
Presented previously reported results from the Phase 2a study of
AKB-6548 at the 2014
European Renal Association-European Dialysis and Transplant Association 51stCongress inAmsterdam
Second 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 second 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 expected timing of the
announcement of data from the Phase 2b study, the growth of the chronic
kidney disease patient population and the projected use of Akebia's
existing cash resources. 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 or any other
product candidate; the funding required to develop Akebia's product
candidates and operate the Company, and the actual expenses associated
therewith; the content of decisions made by the FDA and other regulatory
authorities; the actual time it takes to complete the Phase 2b study and
analyze the data; the success of competitors in developing product
candidates for diseases for which Akebia is currently developing its
product candidates; the introduction or adoption of therapeutic
interventions that slow the progression of chronic kidney disease; and
Akebia's ability to obtain, maintain and enforce patent and other
intellectual property protection for AKB-6548 or any other product
candidates. 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
Condensed Statement of Operations (in thousands except share and per share data) (unaudited) |
||||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||||
|
|
|
|
|||||||||||||||
Revenue | $ |
— |
$ |
— |
$ |
— |
$ |
— |
||||||||||
Operating expenses: |
|
|||||||||||||||||
Research and development |
5,525 |
2,453 | 11,683 | 4,351 | ||||||||||||||
General and administrative | 2,315 | 668 | 6,066 | 1,347 | ||||||||||||||
Total operating expenses | 7,840 | 3,121 | 17,749 | 5,698 | ||||||||||||||
Operating loss | (7,840 | ) | (3,121 | ) | (17,749 | ) | (5,698 | ) | ||||||||||
Other income (expense), net | 222 | 291 | 434 | 2,247 | ||||||||||||||
Net loss and comprehensive loss | $ | (7,618 | ) |
$ |
(2,830 | ) | $ | (17,315 | ) |
$ |
(3,451 | ) | ||||||
Reconciliation of net loss to net loss applicable to common stockholders: |
||||||||||||||||||
Net loss | $ | (7,618 | ) | $ | (2,830 | ) | $ | (17,315 | ) | $ | (3,451 | ) | ||||||
Accretion on preferred stock | — | (49,265 | ) | (86,900 | ) | (50,113 | ) | |||||||||||
Loss on extinguishment of preferred stock | — | — | — | — | ||||||||||||||
Net loss applicable to common stockholders | $ | (7,618 | ) | $ | (52,095 | ) | $ | (104,215 | ) | $ | (53,564 | ) | ||||||
Net loss per share applicable to common stockholders—basic and diluted |
$ | (0.39 | ) | $ | (103.19 | ) | $ | (9.48 | ) | $ |
(109.21 |
) |
||||||
Weighted-average number of common shares used in net loss per share applicable to common stockholders'—basic and diluted |
19,652,056 | 504,868 | 10,987,692 | 490,472 | ||||||||||||||
Selected Balance Sheet Data (in thousands) (unaudited) |
||||||||||
|
|
|||||||||
Cash, cash equivalents and short-term investments | $ |
124,246 |
|
$ | 32,556 | |||||
Working capital | 121,281 | 29,529 | ||||||||
Total assets | 126,358 | 34,665 | ||||||||
Total stockholders' equity (deficit) | 121,552 | (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