scPharmaceuticals Inc. Provides FUROSCIX® Update and Announces Completion of $20.0 Million Term Loan Agreement
September 18 2019 - 8:00AM
scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company
focused on developing and commercializing products that have the
potential to optimize the delivery of infused therapies, advance
patient care, and reduce healthcare costs, today provided an update
on FUROSCIX and announced a new $20.0 million term loan with Solar
Capital Ltd. and Silicon Valley Bank.
“We continue to make excellent progress advancing the FUROSCIX
program in preparation for the resubmission of the new drug
application (NDA),” said John Tucker, president and chief executive
officer of scPharmaceuticals. “Having completed our initial drug
stability work and being on schedule to start the second of two
human factors studies, we feel comfortable reconfirming our
timelines and expectations for a mid-year 2020 resubmission of the
FUROSCIX NDA. Additionally, as we look forward towards our
longer-term funding needs, we are pleased to announce the closing
of a new $20.0 million term loan agreement. With a strong cash
position already in place, the access to the additional capital
from the new term loan further strengthens our financial
flexibility as we approach key regulatory and commercial
milestones.”
FUROSCIX Update
FUROSCIX is scPharmaceuticals’ lead program for the treatment of
congestion in patients with heart failure. The Company continues to
execute on key milestones ahead of resubmission of the NDA,
including drug stability testing, the advancement of its second
human factors study, and increasing awareness of FUROSCIX within
the medical community. The Company is reiterating prior guidance
and remains confident it will resubmit the FUROSCIX NDA with the
U.S. Food and Drug Administration (FDA) by mid-year 2020.
- Completed initial drug stability work.
Drug stability testing is a required element of the
FUROSCIX resubmission and a requirement of all drug products
undergoing regulatory review. The Company has recently completed
the requisite three primary batches of drug product. These
batches will form the basis of the drug stability portion of the
FUROSCIX resubmission.
- Company remains on track to initiate the second of two
planned FUROSCIX human factors studies. Two human
factors studies designed to assess and optimize user interaction
with the FUROSCIX Infusor interface are to be conducted under the
current 505(b)(2) approval pathway for FUROSCIX. The Company
announced the completion of the first study in August 2019. The
Company has submitted and received feedback from the FDA on the
human factors validation study and is on track to complete the
second study by the end of the year. The second study will evaluate
the usability of FUROSCIX by patients, caregivers, and healthcare
providers.
- Presentation at the 23rd Annual Heart Failure Society
of America (HFSA) Scientific Meeting. A poster on
the use of FUROSCIX in patients after hospitalization for acute
decompensated heart failure was presented at the HFSA on September
14th, 2019, in Philadelphia, PA. “It is encouraging to see
continued diuresis and decongestion with FUROSCIX in patients,
post-hospital discharge, for an episode of acute decompensated
heart failure. We look forward to continuing to evaluate the
clinical and economic benefits of this novel approach,” said G.
Michael Felker, MD, Principal Investigator of the Sub-Q Study
titled, Subcutaneous furosemide in the treatment of patients after
hospitalization with acute decompensated heart failure.
Financing Update
- Completed new $20.0 million term loan with Solar
Capital Ltd. and Silicon Valley Bank. The Company
announced a restructured four-year term loan facility that allows
for an expansion of the Company’s prior $10.0 million credit
facility to $20.0 million, all of which has been drawn at closing.
The proceeds from the loan will be used to pay off the existing
$10.0 million term loan along with related fees and expenses, and
to provide additional working capital for general corporate
purposes. The restated and amended agreement extends the term of
the credit facility until September 17, 2023 and permits the
Company to make interest-only payments until October 1, 2021.
About FUROSCIX
FUROSCIX is a proprietary furosemide solution formulated to a
neutral pH to allow for subcutaneous infusion via a wearable,
subcutaneous injector with an integrated drug delivery system,
for outpatient self-administration. FUROSCIX is being developed for
treatment of congestion, or fluid overload, in patients with heart
failure. FUROSCIX has the potential to provide an outpatient
alternative for the treatment of worsening heart failure due to
congestion.
About scPharmaceuticals
scPharmaceuticals is a pharmaceutical company focused on
developing and commercializing products that are designed to reduce
healthcare costs and improve health outcomes. The Company develops,
internally and through strategic partnerships, innovative products
and solutions that aim to expand and advance the outpatient care of
select acute conditions. The Company’s lead programs focus on the
subcutaneous, self-administration of IV-strength treatments in
heart failure and infectious disease. scPharmaceuticals is
headquartered in Burlington, MA. For more information, please visit
scPharmaceuticals.com
Forward-Looking StatementThis press release
contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995. These
forward-looking statements include, but are not limited to,
statements regarding the planned resubmission of the FUROSCIX NDA,
including potential timing of the resubmission, the Company’s drug
stability testing, the advancement of the Company’s human factors
studies, and the Company’s financial condition and cash runway,
including the intended use of the proceeds of the new term loan
facility. Any forward-looking statements in this press release are
based on management’s current expectations of future events and are
subject to a number of risks and uncertainties that could cause
actual results to differ materially and adversely from those set
forth in or implied by such forward-looking statements. These risks
and uncertainties include, but are not limited to, the ability of
the FUROSCIX Infusor to appropriately deliver therapy, the receipt
of regulatory approval for FUROSCIX Infusor or any of our other
product candidates or, if approved, the successful
commercialization of such products, the risk of cessation or delay
of any of the ongoing or planned clinical trials and/or our
development of our product candidates, and the risk that the
results of previously conducted studies will not be repeated or
observed in ongoing or future studies involving our product
candidates. For a discussion of other risks and uncertainties, and
other important factors, any of which could cause our actual
results to differ from those contained in the forward-looking
statements, see the section entitled “Risk Factors” in the
Company’s most recent Annual Report on Form 10-K on file with the
Securities and Exchange Commission, as well as discussions of
potential risks, uncertainties and other important factors in the
Company’s subsequent filings with the Securities and Exchange
Commission. All information in this press release is as of the date
of the release, and the Company undertakes no duty to update this
information unless required by law.
Contacts:Katherine Taudvin, scPharmaceuticals
Inc.781-301-6706ktaudvin@scpharma.com
Christopher F. Brinzey, Westwicke, an ICR
Company339-970-2843chris.brinzey@westwicke.com
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