Biotech

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients through the biology of hypoxia-inducible factor (HIF), today announced financial results for the first quarter ended March 31, 2016. Akebia also provided an update on its Phase 3 INNO2VATE program for vadadustat in dialysis-dependent chronic kidney disease (DD-CKD), and reported data …

CAMBRIDGE, Mass.–(BUSINESS WIRE)–Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company
focused on delivering innovative therapies to patients through the
biology of hypoxia-inducible factor (HIF), today announced financial
results for the first quarter ended March 31, 2016. Akebia also provided
an update on its Phase 3 INNO2VATE program for
vadadustat in dialysis-dependent chronic kidney disease (DD-CKD), and
reported data from an ethnobridging study for vadadustat.
“We continue to execute our strategy designed to position vadadustat as
a best-in-class treatment for renal anemia, define a clear path to
registration and establish strong commercial support in key markets,”
said John P. Butler, President and Chief Executive Officer of Akebia.
“With the recent European Patent Office decision, we have preserved our
access to an important region and are well-positioned to pursue a
European collaboration that would provide funding for the balance of our
Phase 3 program.”
Mr. Butler continued, “On the clinical front, we have now reached
alignment with regulators regarding our global Phase 3 program. We are
advancing our ongoing global Phase 3 PRO2TECT program in
non-dialysis dependent patients (NDD-CKD), and look forward to
initiating the INNO2VATE program in DD-CKD patients in the
third quarter of 2016. We are also expanding our experience with HIF-PH
inhibitors, and plan to begin a Phase 1 trial with our second clinical
candidate, AKB-6899, this year.”
INNO2VATE Program
Akebia announced today that it has reached alignment with both the U.S.
Food and Drug Administration (FDA) and the European Medicines Agency
(EMA) regarding key elements of the Phase 3 INNO2VATE
program and expects to launch the program in the third quarter of 2016.
The INNO2VATE program includes two separate studies and will
collectively enroll approximately 2,600 DD-CKD patients globally. The
correction study will enroll approximately 400 patients not currently
being treated with recombinant erythropoiesis stimulating agents
(rESAs). The conversion study will enroll approximately 2,200 patients
currently receiving rESA who will be converted to either vadadustat or
the active control with the goal of maintaining their baseline
hemoglobin levels. Both studies will include a 1:1 randomization and an
open label, active-control, non-inferiority design. Primary endpoints
include an efficacy assessment of the hemoglobin response and an
assessment of cardiovascular safety measured by major adverse
cardiovascular events.
Ethnobridging Study Results
The company announced today that data from its recent ethnobridging
study demonstrated that the pharmacokinetics of vadadustat in Japanese
volunteers is similar to that in Caucasians at all doses studied. The
double-blind study was designed to assess the pharmacokinetics and
pharmacodynamics of vadadustat following the administration of multiple
ascending doses (150 mg, 300 mg and 600 mg) once daily for 10 days in
Japanese and Caucasian healthy volunteers. At all doses studied, the
pharmacokinetics and pharmacodynamics of vadadustat in the Japanese
population were similar to that observed in Caucasians.
“As we anticipated, these results demonstrate that ethnicity has no
effect on the clearance of vadadustat, an important finding that further
supports our global development and commercialization strategy in Japan
and other Asian markets,” stated Brad Maroni, Chief Medical Officer of
Akebia. “Together with our partner in Asia, Mitsubishi Tanabe, we look
forward to incorporating these results into our plans for vadadustat in
the region.”
First Quarter 2016 Corporate Highlights

  • Preserved access to the European market for vadadustat by prevailing
    in a patent dispute in which the European Patent Office confirmed that
    none of FibroGen, Inc.’s patent claims met the requirements for
    patentability and, as a result, revoked the patent in its entirety;
    and,
  • Raised approximately $61.0 million, net, in a public offering of
    approximately 7.3 million shares of common stock in January 2016.

Financial Results
Akebia reported a net loss of ($25.8) million, or ($0.70) per share, for
the first quarter of 2016. Net loss for the first quarter of 2015 was
($10.7) million or ($0.53) per share.
Research and development expenses were $20.2 million for the first
quarter of 2016 compared to $6.7 million for the first quarter of 2015.
The increase is primarily attributable to costs related to the
initiation of the PRO2TECT Phase 3 program. Research and
development expenses were further increased by personnel-related costs
due to additional headcount.
General and administrative expenses were $5.8 million for the first
quarter of 2016 compared to $4.2 million for the first quarter of 2015.
The increase is primarily due to the following expense increases: $0.8
million due to increased headcount and compensation related costs and
$0.8 million in commercial planning costs as well as legal costs.
The Company’s cash provided by operations during the first quarter of
2016 was $17.4 million, an increase of $25.8 million from $8.3 million
used in operations for the same period of 2015. The increase is
primarily related to the upfront payment of $40.0 million received in
January 2016 from Mitsubishi Tanabe in connection with our collaboration
agreement. The Company ended the first quarter of 2016 with cash, cash
equivalents and available for sale securities of $217.0 million and
expects its cash resources to fund its current operating plan through at
least the second quarter of 2017.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a biopharmaceutical company headquartered
in Cambridge, Massachusetts, focused on delivering innovative therapies
to patients with kidney disease through hypoxia-inducible factor (HIF)
biology. Akebia has completed Phase 2 development of its lead product
candidate, vadadustat (formerly AKB-6548), an oral therapy for the
treatment of anemia related to chronic kidney disease (CKD) in both
non-dialysis and dialysis patients. Enrollment in the PRO2TECT
Phase 3 program in NDD-CKD patients commenced in late 2015 and the INNO2VATE
Phase 3 program in DD-CKD patients is expected to commence in 2016.
Akebia’s second product candidate, AKB-6899, is expected to commence
clinical development in 2016. For more information, please visit our
website at www.akebia.com.
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 establishment of a European
collaboration and the potential funding associated therewith, the timing
and expected size of the INNO2VATE and PRO2TECT
clinical programs, and the commencement of clinical development for
AKB-6899. 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; Akebia’s ability to
negotiate commercially reasonable terms with a European collaboration
partner, including economics sufficient to fund the global Phase 3
program; 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 1 study of AKB-6899 and 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 and AKB-6899; the actual time it takes to prepare for and
initiate 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. 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 March 31, 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
March 31, 2016 March 31, 2015
Operating expenses:
Research and development $ 20,235 $ 6,664
General and administrative 5,811 4,232
Total operating expenses 26,046 10,896
Operating loss (26,046 ) (10,896 )
Other income, net 248 201
Net loss $ (25,798 ) $ (10,695 )
Net loss per share applicable to common stockholders—basic and
diluted
$ (0.70 ) $ (0.53 )
Weighted-average number of common shares used in net loss per share
applicable to

common stockholders—basic and diluted

36,873,594 20,030,129
AKEBIA THERAPEUTICS, INC.
Selected Balance Sheet Data
(in thousands)
(unaudited)
March 31,

2016

December 31,

2015

Cash, cash equivalents and available for sale securities $ 217,025 $ 138,454
Working capital 206,121 129,149
Total assets 221,440 142,940
Total stockholders’ equity 167,762 130,998
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