Press Release
Akebia Announces Third Quarter 2016 Financial Results
-- Multiple Publications Highlight Vadadustat's Potential to Treat Renal Anemia and the Need for New Therapies for Chronic Kidney Disease --
-- Company Expands Leadership Team with Additional Expertise in HIF Biology and Clinical Development --
"This quarter, we continued to advance our Phase 3 program for
vadadustat with the initiation of INNO2VATE for
dialysis-dependent patients with anemia related to chronic kidney
disease, our second potential indication. In addition, the Independent
Data Monitoring Committee for the PRO2TECT program for
non-dialysis patients met for the first time and recommended continuing
the program without modification," said
Third Quarter 2016 and Recent Corporate Highlights
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Peer-Reviewed Publications Highlight Vadadustat's Potential and
Need for New Treatment Options
Positive Phase 2b data were published in a peer-reviewed paper, titled "Vadadustat, a novel oral HIF stabilizer, provides effective anemia treatment in non-dialysis-dependent chronic kidney disease," inKidney International . Two additional peer-reviewed publications emphasized the need for new treatment options for chronic kidney disease (CKD) patients currently being treated with erythropoiesis-stimulating agent (ESA). One study, published inAmerican Journal of Kidney Diseases , highlighted thatESA hyporesponsiveness continues to be a potent prognostic marker for increased risk of death, despite dramatic changes in anemia management since 2011. Another study, published inJournal of Nephrology , confirmed that higher altitude is associated with higher hemoglobin levels and lower mortality despite lower utilization ofESA and intravenous iron. The study suggests that investigational treatments currently in development that simulate the body's natural response to higher altitude, such as vadadustat, may be beneficial for patients with renal anemia. -
Independent Data Monitoring Committee for PRO 2TECT Phase 3 Program Holds First Meeting
The Independent Data Monitoring Committee for Akebia's global Phase 3 PRO2TECT program held the initial meeting according to its charter and recommended continuing the studies without modification.
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Abstracts Published Featuring Data from the
Vadadustat Development Program
Abstracts were published featuring data from the vadadustat development program in both dialysis-dependent and non-dialysis dependent CKD patients, which will be presented at the upcoming ASN/ Kidney Week 2016 meeting fromNovember 15-18, 2016 .
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Strengthened Senior Leadership Team with
Key Hires Karen Tubridy , PharmD, is joining Akebia as Senior Vice President, Chief Development Officer, with greater than 20 years of global drug development experience including translational research.Michael Rabinowitz , Ph.D., a highly experienced scientist and HIF biology expert who led the research team focused on leveraging HIF biology at Johnson & Johnson, has joined Akebia as Vice President, Research.
Financial Results
The company reported a net loss of
As previously reported, revenue recognition for the company's
Collaboration Agreement with Mitsubishi Tanabe Pharma Corporation is
expected to begin in 2017 when the scope of the Phase 3 program is
agreed upon with Japanese regulatory authorities and when all revenue
recognition criteria, as defined by accounting standards for the
transaction, have been satisfied. Accordingly, the company did not
record any revenue for the third quarter of 2016 and, as of
Research and development expenses were
General and administrative expenses were
The company's cash used in operations during the third quarter of 2016
was
About
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
vadadustat, the progress toward securing a geographic collaboration and
the expected financial impact of such collaboration, planned
presentations of data and potential revenue recognition in 2017. 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 vadadustat; the funding required to develop
Akebia's product candidates and operate the company, and the actual
expenses associated therewith; the cost of the Phase 3 studies of
vadadustat and the availability of financing to cover such costs; the
timing and content of decisions made by the
Tables Follow:
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Three Months Ended | Nine Months Ended | ||||||||||||||||||||
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Operating expenses: | |||||||||||||||||||||
Research and development | $ | 31,238 | $ | 15,604 | $ | 82,350 | $ | 28,772 | |||||||||||||
General and administrative | 4,944 | 4,074 | 16,066 | 12,691 | |||||||||||||||||
Total operating expenses | 36,182 | 19,678 | 98,416 | 41,463 | |||||||||||||||||
Operating loss | (36,182 | ) | (19,678 | ) | (98,416 | ) | (41,463 | ) | |||||||||||||
Other income, net | (126) | 203 | 531 | 604 | |||||||||||||||||
Net loss | $ | (36,308 | ) | $ | (19,475 | ) | $ | (97,885 | ) | $ | (40,859 | ) | |||||||||
Net loss per share applicable to common stockholders—basic and diluted | $ | (0.96 | ) | $ | (0.68 | ) | $ | (2.61 | ) | $ | (1.62 | ) | |||||||||
Weighted-average number of common shares used in net loss per share
applicable to
common stockholders—basic and diluted |
37,897,902 | 28,784,231 | 37,528,869 | 25,175,077 |
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Cash, cash equivalents and available for sale securities | $ | 161,322 | $ | 138,454 | ||||
Working capital | 139,008 | 129,149 | ||||||
Total assets | 169,118 | 142,940 | ||||||
Total stockholders' equity | 100,710 | 130,998 |
View source version on businesswire.com: http://www.businesswire.com/news/home/20161109006219/en/
Akebia Contact
AJ Gosselin, 617-844-6130
Manager,
Corporate Communications
agosselin@akebia.com
Source:
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Akebia Therapeutics, Inc.
245 First Street, Suite 1400
Cambridge, MA 02142
+1 617.871.2098 phone
+1 617.871.2099 fax