scPharmaceuticals Inc. Reports Third Quarter 2018 Financial Results and Provides Business Update
November 13 2018 - 8:00AM
Resubmission of FURSOCIX® with the U.S. Food and
Drug Administration (FDA) by year-end 2019
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 announced financial
results for the third quarter ended September 30, 2018 and provided
a business update.
“After receiving the minutes from our Type A Post-Action Meeting
for FUROSCIX, we have directed our attention to the activities
required to re-file our New Drug Application (NDA),” said John
Tucker, president and chief executive officer of scPharmaceuticals.
“FUROSCIX is a unique product with the potential to treat edema, or
fluid overload, in patients with heart failure. Heart failure
remains a large market opportunity with high unmet patient need and
significant associated healthcare costs.”
Business Highlights
- Provided regulatory update on FUROSCIX. On
October 18, 2018, scPharmaceuticals announced it received minutes
from the Type A Post-Action Meeting held on September 24, 2018
between the Company and the FDA to discuss the Company’s NDA for
FUROSCIX. As an outcome of the meeting, the FDA has asked the
Company to conduct additional human factors studies and a dose
delivery validation study, with the recently modified FUROSCIX
Infusor. The FDA has not requested additional clinical trials at
this time.
- FDA granted Type C Meeting. In response to the
October 18, 2018 minutes from the Type A Post-Action Meeting and
the FDA’s request for a dose delivery validation study, the Company
requested, and was granted by the FDA, a Type C Meeting to be held
on January 9, 2019 to discuss the dose delivery validation
protocol.
- Anticipate FUROSCIX NDA to be re-filed with the FDA by
year-end 2019. Based on the requirements from the FDA
minutes, and pending the feedback from the Type C Meeting, the
Company anticipates completing human factors and dose delivery
validation studies in time to re-file the FUROSCIX NDA by year-end
2019.
Third Quarter 2018 Financial Results and Financial
Guidance
scPharmaceuticals reported a net loss of $5.8 million in the
third quarter of 2018 compared to $5.5 million for the third
quarter of 2017. The increase in net loss for the third quarter
ended September 30, 2018, was largely due to costs associated with
increased headcount, clinical initiatives, and costs incurred as a
public company.
Research and development expenses were $3.9 million for the
third quarter of 2018 compared to $3.6 million for the comparable
period in 2017. The increase in research and development expenses
for the quarter ended September 30, 2018 was largely due to
increased headcount and costs associated with clinical
initiatives.
General and administrative expenses were $1.9 million for the
third quarter of 2018 compared to $1.7 million for the comparable
period in 2017. The increase in general and administrative expenses
for the period was primarily due to costs incurred as a public
company.
scPharmaceuticals ended the third quarter of 2018 with $95.5
million in cash compared to $118.5 million as of December 31, 2017.
This change reflects the ongoing investment in product and clinical
development, as well as the costs incurred in the Company’s
transition to a public company and costs associated with preparing
for the potential commercialization of FUROSCIX.
Based on its current operating plan, scPharmaceuticals expects
year end 2018 cash and cash equivalents and investment securities
to be approximately $82 - $87 million, an increase over prior
guidance of $80 - $85 million, and forecasts 2019 expenditures of
$8 - $10 million per quarter, consistent with prior guidance.
About FUROSCIX
FUROSCIX is a proprietary furosemide solution formulated to a
neutral pH to allow for subcutaneous infusion via the patented
Infusor, a wearable, pre-programed drug delivery system that is
applied to the abdomen for subcutaneous drug administration.
FUROSCIX is being developed for treatment of edema, 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 edema.
About scPharmaceuticals
scPharmaceuticals is a clinical-stage pharmaceutical company
focused on developing and commercializing products that reduce
healthcare costs and improve health outcomes. The
Company develops products for 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 timing of the Company’s resubmission of
its NDA for FUROSCIX; the Company’s plans to meet with the FDA to
discuss validation study protocols; the Company’s completion of
human factors and dose delivery validation studies; the potential
timing and advancement of the Company’s ongoing or planned clinical
trials and investigator-sponsored studies; the announcement of data
from these trials and studies; and the Company’s financial
condition and results of operations for the year end 2018 and for
fiscal year 2019. 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 Company conducting human factors studies or a dose
delivery validation study, the ability of our device to
appropriately deliver therapy, the receipt of regulatory approval
for FUROSCIX or any 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:Troy Ignelzi, scPharmaceuticals
Inc.781-301-7216tignelzi@scpharma.com
Christopher F. Brinzey, Westwicke
Partners339-970-2843chris.brinzey@westwicke.com
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scPharmaceuticals Inc. |
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Unaudited Statements of Operations and Comprehensive
Loss |
|
|
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|
|
|
| (in thousands, except
share and per share data) |
|
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|
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THREE MONTHS ENDED SEPTEMBER 30, |
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NINE MONTHS ENDED SEPTEMBER 30, |
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2017 |
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2018 |
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2017 |
|
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2018 |
|
| Operating
expenses: |
|
|
|
|
|
|
|
| Research
and development |
$ |
3,585 |
|
|
$ |
3,896 |
|
|
$ |
10,615 |
|
|
$ |
12,799 |
|
| General
and administrative |
|
1,665 |
|
|
|
1,945 |
|
|
|
6,113 |
|
|
|
11,645 |
|
| Total
operating expenses |
|
5,250 |
|
|
|
5,841 |
|
|
|
16,728 |
|
|
|
24,444 |
|
| Loss from
operations |
|
(5,250 |
) |
|
|
(5,841 |
) |
|
|
(16,728 |
) |
|
|
(24,444 |
) |
| Other income
(expense) |
|
15 |
|
|
|
(5 |
) |
|
|
82 |
|
|
|
(58 |
) |
| Interest income |
|
75 |
|
|
|
445 |
|
|
|
170 |
|
|
|
1,221 |
|
| Interest expense |
|
(329 |
) |
|
|
(360 |
) |
|
|
(461 |
) |
|
|
(1,062 |
) |
| Net loss and
comprehensive loss |
$ |
(5,489 |
) |
|
$ |
(5,761 |
) |
|
$ |
(16,937 |
) |
|
$ |
(24,343 |
) |
| Net loss per share,
basic and diluted |
$ |
(5.08 |
) |
|
$ |
(0.31 |
) |
|
$ |
(15.76 |
) |
|
$ |
(1.31 |
) |
| Weighted—average common
shares outstanding, basic and diluted |
|
1,080,351 |
|
|
|
18,569,289 |
|
|
|
1,074,702 |
|
|
|
18,551,690 |
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scPharmaceuticals Inc. |
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| Unaudited
Balance Sheet Data |
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| (in thousands) |
|
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DECEMBER 31, 2017 |
|
SEPTEMBER 30, 2018 |
| Cash, cash equivalents
and restricted cash |
|
$ |
118,480 |
|
|
$ |
95,481 |
|
| Working capital |
|
|
114,672 |
|
|
|
89,401 |
|
| Total assets |
|
|
122,048 |
|
|
|
98,819 |
|
| Term loan |
|
|
9,419 |
|
|
|
9,631 |
|
| Accumulated
deficit |
|
|
(67,016 |
) |
|
|
(91,360 |
) |
| Total stockholders’
equity |
|
|
105,997 |
|
|
|
83,390 |
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