-- 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 --
Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical
company focused on delivering innovative therapies to patients with
kidney disease through the biology of hypoxia-inducible factor
(HIF), today announced financial results for the third quarter
ended September 30, 2016.
“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 John P. Butler, President and Chief Executive
Officer of Akebia. “Clinical results of vadadustat were published
for the first time, and multiple publications highlighted the
clinical need for new treatment options such as vadadustat.
Importantly, we added significant depth to our management team to
not only drive our Phase 3 program, but also to focus on building
our pipeline. Our pursuit of a geographic collaboration for
vadadustat remains a core focus, with the goal of providing a
strong commercial partner and the resources to finance the balance
of our Phase 3 program.”
Third Quarter 2016 and Recent Corporate Highlights
- Peer-Reviewed Publications Highlight
Vadadustat’s Potential and Need for New Treatment
OptionsPositive 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,” in Kidney 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 in
American Journal of Kidney Diseases, highlighted that ESA
hyporesponsiveness continues to be a potent prognostic marker for
increased risk of death, despite dramatic changes in anemia
management since 2011. Another study, published in Journal of
Nephrology, confirmed that higher altitude is associated with
higher hemoglobin levels and lower mortality despite lower
utilization of ESA 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 PRO2TECT Phase 3 Program Holds First
MeetingThe 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.
- Abstracts Published Featuring Data
from the Vadadustat Development ProgramAbstracts 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
from November 15-18, 2016.
- Strengthened Senior Leadership Team
with Key HiresKaren 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.
Mr. Butler added, “We were pleased to learn that the
physician-scientists who discovered the HIF pathway and examined
the body’s physiologic response to changes in oxygen levels had
recently received the 2016 Albert Lasker Basic Medical Research
Award, a prestigious recognition of groundbreaking research. Their
foundational work underscores the potential benefits of HIF-based
therapies, such as vadadustat, which are being developed to exploit
the same mechanism of action to treat renal anemia.”
Financial ResultsThe company reported a net loss of
($36.3) million, or ($0.96) per share, for the third quarter of
2016. Net loss for the third quarter of 2015 was ($19.5) million or
($0.68) per share.
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
September 30, 2016, the company had $40.0 million of deferred
revenue.
Research and development expenses were $31.2 million for the
third quarter of 2016, compared to $15.6 million for the third
quarter of 2015. The increase is primarily attributable to external
costs related to the PRO2TECT Phase 3 program, as well initiation
costs of the INNO2VATE Phase 3 program. Research and development
expenses increased due to additional headcount and
compensation-related costs.
General and administrative expenses were $4.9 million for the
third quarter of 2016, compared to $4.1 million for the third
quarter of 2015. The increase is primarily due to an increase in
costs to support the company’s Phase 3 program, including headcount
and compensation-related costs, and associated facility-related
costs.
The company’s cash used in operations during the third quarter
of 2016 was $28.4 million, an increase of $19.4 million from the
$9.0 million used in operations for the same period of 2015. The
increase was primarily related to costs associated with the global
Phase 3 program for vadadustat, which studies commenced during the
fourth quarter of 2015 in non-dialysis CKD patients and in the
third quarter of 2016 in patients undergoing dialysis. The company
ended the third quarter of 2016 with cash, cash equivalents and
available securities of $161.3 million, and continues to expect
cash resources to fund the current operating plan through the
second quarter of 2017.
About Akebia TherapeuticsAkebia Therapeutics, Inc. is a
biopharmaceutical company headquartered in Cambridge,
Massachusetts, focused on delivering innovative therapies to
patients with kidney disease through hypoxia-inducible factor
biology. Akebia’s lead product candidate, vadadustat, is an oral
therapy in development for the treatment of anemia related to
chronic kidney disease in both non-dialysis and dialysis patients.
Akebia has commenced its vadadustat Phase 3 Program, which includes
the PRO2TECT studies for non-dialysis patients with anemia
secondary to chronic kidney disease and the INNO2VATE studies for
dialysis-dependent patients. For more information, please visit our
website at www.akebia.com.
Forward-Looking StatementsThis 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 FDA and other regulatory authorities; the
rate of enrollment in clinical studies of vadadustat; the actual
time it takes to initiate and complete clinical studies; the
development plan for vadadustat in Japan; Akebia's ability to
negotiate commercially reasonable terms with a geographic
collaboration partner, including economics sufficient to fund the
global Phase 3 program; 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 vadadustat. Other risks and uncertainties include
those identified under the heading “Risk Factors” in Akebia's
Annual Report on Form 10-Q for the quarter ended September 30,
2016, and other filings that Akebia may make with the Securities
and Exchange Commission in the future. Akebia does not undertake,
and specifically disclaims, any obligation to update any
forward-looking statements contained in this press release.
Tables Follow:
AKEBIA THERAPEUTICS,
INC.Consolidated Statements of Operations(in
thousands except share and per share
data)(unaudited)
Three Months Ended
Nine Months Ended
September 30,2016
September 30,2015
September 30,2016
September 30,2015
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
AKEBIA THERAPEUTICS,
INC.Selected Balance Sheet Data(in
thousands)(unaudited)
September 30,2016
December 31,2015
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
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version on businesswire.com: http://www.businesswire.com/news/home/20161109006219/en/
Akebia ContactAJ Gosselin, 617-844-6130Manager, Corporate
Communicationsagosselin@akebia.com
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