--Partner Mitsubishi Tanabe Pharma Corporation
Initiates Phase 3 Development Program for Vadadustat in Japan--
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, 2017.
“Akebia continues to execute on our global Phase 3 program for
vadadustat in collaboration with our partners,” said John P.
Butler, President and Chief Executive Officer of Akebia
Therapeutics. “In the third quarter, we announced positive Phase 2
top-line results from our vadadustat study in Japanese patients
with non-dialysis-dependent chronic kidney disease, and findings
from the Phase 2 study in dialysis-dependent patients are expected
by year end. In addition, our partner, Mitsubishi Tanabe Pharma
Corporation, announced the initiation of Phase 3 clinical studies
of vadadustat in Japan. Enrollment continues in the global clinical
program with the potential launch of vadadustat in the United
States, Europe and Japan anticipated in 2020. In addition, we look
forward to initiating our TRILO2GY study later this year or early
2018.”
Third Quarter 2017 and Recent Corporate Highlights
- Announced positive top-line results
from a Phase 2 study of vadadustat in Japanese patients with
non-dialysis-dependent chronic kidney disease, which confirmed
findings from previous studies of vadadustat;
- After a positive consultation with the
PMDA, partner Mitsubishi Tanabe Pharma Corporation (MTPC) announced
the initiation of a Phase 3 development program of vadadustat in
non-dialysis patients and patients receiving peritoneal dialysis
in Japan;
- Provided MTPC with an option to access
data from Akebia’s global Phase 3 vadadustat program for payments
to Akebia of up to $25 million; and
- The Independent Data Monitoring
Committee for Akebia’s global Phase 3 PRO2TECT and INNO2VATE
programs held another meeting and recommended continuing the
studies without modification.
Financial Results
Akebia reported a net loss of ($23.1) million, or ($0.49) per
share, for the third quarter of 2017 as compared to a net loss for
the third quarter of 2016 of ($36.3) million or ($0.96) per
share.
Collaboration revenue was $41.3 million for the third quarter of
2017, which related to the Company’s agreements with Otsuka.
Collaboration revenue in connection with Akebia’s agreement with
MTPC is expected to commence in the fourth quarter of 2017.
Research and development expenses were $58.7 million for the
third quarter of 2017 compared to $31.2 million for the third
quarter of 2016. The increase is primarily attributable to external
costs related to the global PRO2TECT and INNO2VATE Phase 3
programs, the Phase 2 studies in Japan, and activities related to
the FO2RWARD and TRILO2GY programs. Research and development
expenses were further increased by headcount and
compensation-related costs.
General and administrative expenses were $6.7 million for the
third quarter of 2017 compared to $4.9 million for the third
quarter of 2016. The increase is primarily attributable to an
increase in costs to support the Company’s research and development
programs, including headcount and compensation-related costs and
associated facility and patent-related costs.
Akebia ended the third quarter of 2017 with cash, cash
equivalents and marketable securities of $329.7 million. The
Company’s collaborators have committed up to $373.0 million or more
in license and cost-share funding, which Akebia continues to
receive on a quarterly prepaid basis. Akebia expects existing cash
resources to fund the Company’s current operating plan into the
second quarter of 2019. Thereafter, committed research and
development funding will continue to be received from Otsuka on a
prepaid, quarterly basis.
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, investigational therapy in development for the treatment of
anemia related to chronic kidney disease in both non-dialysis and
dialysis patients. Akebia’s global Phase 3 program for vadadustat,
which includes the PRO2TECT studies for non-dialysis patients with
anemia secondary to chronic kidney disease and the INNO2VATE
studies for dialysis-dependent patients, is currently ongoing. In
addition, the Company has initiated the Phase 2 FO2RWARD study of
vadadustat in dialysis-dependent chronic kidney disease patients
who are hyporesponsive to erythropoiesis-stimulating agents (ESAs),
and expects to commence the Phase 3 TRILO2GY study to further
evaluate a three-times-weekly dosing regimen for vadadustat. 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 regulatory approval of
vadadustat, the potential commercialization of vadadustat if
approved by regulatory authorities, the potential indications and
benefits of vadadustat, the expected timing of clinical studies,
anticipated financial contributions from MTPC and Otsuka, and
anticipated sufficiency of 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 actual funding
required to develop Akebia’s product candidates and operate the
company, and the actual expenses associated therewith; the actual
costs incurred in the clinical studies of vadadustat and the
availability of financing to cover such costs; early termination of
Akebia’s agreements with its partners; Akebia’s ability to satisfy
its obligations under its agreements; the timing and content of
decisions made by the regulatory authorities; the timing of any
additional studies initiated by Akebia or its partners for
vadadustat; the rate of enrollment in clinical studies of
vadadustat; the actual time it takes to initiate and complete
research and clinical studies; 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 and its 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 quarter ended September 30, 2017, 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, INCConsolidated Statements of
Operations(in thousands except share and per share
data)(unaudited) Three Months
Ended Nine Months Ended
September 30,2017
September 30,2016
September 30,2017
September 30,2016
Collaboration revenue $ 41,283 $ — $ 90,668 $ — Operating expenses:
Research and development 58,711 31,238 162,511 82,350 General and
administrative 6,748 4,944
19,441 16,066 Total operating expenses
65,459 36,182 181,952
98,416 Operating loss (24,176 ) (36,182 ) (91,284 ) (98,416
) Other income, net 1,042 (126)
2,090 531 Net loss $ (23,134 ) $ (36,308 ) $
(89,194 ) $ (97,885 ) Net loss per share - basic and diluted $
(0.49 ) $ (0.96 ) $ (2.11 ) $ (2.61 ) Weighted-average number of
common shares - basic and
diluted
46,938,618 37,897,902 42,202,560
37,528,869
AKEBIA
THERAPEUTICS, INC.Selected Balance Sheet Data(in
thousands)(unaudited)
September 30,2017
December 31,2016
Cash, cash equivalents and available for sale securities $ 329,705
$ 260,343 Working capital 182,581 182,053 Total assets 338,589
300,216 Total stockholders' equity 99,875 68,120
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version on businesswire.com: http://www.businesswire.com/news/home/20171108005991/en/
Akebia TherapeuticsJohn Garabo, 617-844-6130Director,
Corporate Communicationsjgarabo@akebia.com
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