Company Strengthens Cash Position in Advance
of Potential Vadadustat Launch
CAMBRIDGE, Mass., Nov. 2, 2023
/PRNewswire/ -- Akebia Therapeutics®, Inc. (Nasdaq:
AKBA), a biopharmaceutical company with the purpose to better the
lives of people impacted by kidney disease, today announced it has
amended the terms of its loan agreement with Pharmakon Advisors,
LP, the investment manager of the BioPharma Credit funds that it
originally entered into in November
2019. The amendment extends the maturity date of the loan to
March of 2025 from November 11, 2024.
Under the terms of the amendment, Akebia's quarterly principal
payments have been deferred until October
31, 2024 at which time the company will begin making monthly
principal payments. Details of the amended agreement are provided
in the Form 8K filed on November 2,
2023.
"We are pleased to have amended our term loan agreement with
Pharmakon, a favorable modification we believe protects and extends
our cash runway until well after a potential approval for
vadadustat in March 2024," said
John P. Butler, Chief Executive
Officer of Akebia. "Strengthening our cash position in the near
term provides us the flexibility to best enable a successful
commercial launch of vadadustat if approved."
Akebia has $35.0 million of
principal outstanding.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is
a fully integrated biopharmaceutical company with the purpose to
better the lives of people impacted by kidney disease. Akebia was
founded in 2007 and is headquartered in Cambridge, Massachusetts. For more
information, please visit our website at www.akebia.com, which does
not form a part of this release.
About Vadadustat
Vadadustat is an oral
hypoxia-inducible factor prolyl hydroxylase inhibitor designed to
mimic the physiologic effect of altitude on oxygen availability. At
higher altitudes, the body responds to lower oxygen availability
with stabilization of hypoxia-inducible factor, which can lead to
increased red blood cell production and improved oxygen delivery to
tissues. Vadadustat is not approved by the U.S. Food and Drug
Administration. Vadadustat is approved in Europe and Australia for the treatment of symptomatic
anemia due to CKD in adult patients on chronic maintenance
dialysis. In Japan, vadadustat is
approved as a treatment for anemia due to CKD in both
dialysis-dependent and non-dialysis dependent adult patients.
Forward-Looking Statements
Statements in this press
release regarding Akebia Therapeutics,
Inc.'s ("Akebia's") strategy, plans, prospects, expectations,
beliefs, intentions and goals are forward-looking statements within
the meaning of the U.S. Private Securities Litigation
Reform Act of 1995, as amended, and include, but are not limited
to, statements regarding: Akebia's expectations regarding a
decision by the FDA on its NDA for vadadustat, including the timing
thereof; Akebia's expectations and beliefs regarding the impact
that the amendment with Pharmakon will have on Akebia and the
ability of its cash runway to last until well after a potential
approval for vadadustat in March
2024; and Akebia's ability to enable a successful commercial
launch of vadadustat if approved. The terms "intend," "believe,"
"plan," "goal," "expect," "potential," "anticipate," "will,"
"continue," derivatives of these words, and similar references are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Actual
results, performance or experience may differ materially from those
expressed or implied by any forward-looking statement as a result
of various risks, uncertainties and other factors, including, but
not limited to, risks associated with: decisions made by health
authorities, such as the FDA, with respect to regulatory filings,
including the anticipated FDA decision on the NDA for vadadustat
and the potential effects of a negative decision on Akebia's cash
runway; the potential therapeutic benefits, safety profile, and
effectiveness of vadadustat; the potential demand and market
potential and acceptance of, as well as coverage and reimbursement
related to, Auryxia and vadadustat if approved, including estimates
regarding the potential market opportunity; the competitive
landscape for Auryxia and vadadustat if approved, including
potential generic entrants; the ability of Akebia to attract and
retain qualified personnel; Akebia's ability to implement cost
avoidance measures and reduce operating expenses; the results of
preclinical and clinical research; the direct or indirect impact of
the COVID-19 pandemic on regulators and Akebia's business,
operations, and the markets and communities in which Akebia and its
partners, collaborators, vendors and customers operate;
manufacturing, supply chain and quality matters and any recalls,
write-downs, impairments or other related consequences or potential
consequences; and early termination of any of Akebia's
collaborations. 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 June 30, 2023, and
other filings that Akebia may make with the U.S. Securities
and Exchange Commission in the future. These forward-looking
statements (except as otherwise noted) speak only as of the date of
this press release, and, except as required by law, Akebia does not
undertake, and specifically disclaims, any obligation to update any
forward-looking statements contained in this press release.
Akebia Therapeutics® is a trademark of Akebia
Therapeutics, Inc. and its affiliates.
Akebia Therapeutics Contact
Mercedes Carrasco
mcarrasco@akebia.com
View original content to download
multimedia:https://www.prnewswire.com/news-releases/akebia-therapeutics-announces-favorable-payment-term-modification-of-loan-agreement-with-pharmakon-advisors-301976454.html
SOURCE Akebia Therapeutics