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Continued progress on FUROSCIX®; confirming the planned resubmission of FUROSCIX® NDA with the
Company initiated the second of two planned human factors studies
Completed
“We continue to make steady progress on all key project milestones related to the planned mid-2020 resubmission of FUROSCIX to the
Business Highlights
- Continued progress towards FUROSCIX resubmission to the
FDA by mid-year 2020. The Company continues to complete key milestones ahead of resubmission of the New Drug Application (NDA), including significant strides on drug stability testing and the human factors program – no additional clinical trials have been requested as part of the resubmission. The Company is reiterating prior guidance and remains confident it will resubmit the FUROSCIX NDA with theFDA by mid-year 2020.
- Company initiated the second of two planned FUROSCIX human factors studies. Two human factors studies were designed to assess and optimize user interaction with the FUROSCIX Infusor interface under the current 505(b)(2) approval pathway for FUROSCIX. The Company announced the completion of the first study in
August 2019 . The second study has been initiated and will evaluate the usability of FUROSCIX by patients, caregivers, and healthcare providers.
- Entered into new term loan increasing cash position. In September, the Company announced a restructured four-year
$20.0 million term loan facility that replaced the Company’s prior$10.0 million credit facility. The proceeds from the loan were used to pay off the prior$10.0 million term loan along with related fees and expenses and will provide additional working capital for general corporate purposes. This restructured credit facility has a maturity date ofSeptember 17, 2023 and permits the Company to make interest-only payments throughSeptember 30, 2021 .
Third Quarter 2019 Financial Results and Financial Guidance
scPharmaceuticals reported a net loss of
Research and development expenses were
General and administrative expenses were
scPharmaceuticals ended the third quarter of 2019 with
Based on its current operating plan, scPharmaceuticals expects year end 2019 cash and cash equivalents and investment securities to be approximately
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
Forward-Looking Statement
This 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, and the Company’s expected progress towards, the resubmission, the advancement of the Company’s human factors and device verification and validation studies and the Company’s financial condition and cash runway. 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
Contacts:
781-301-6706
ktaudvin@scpharma.com
339-970-2843
chris.brinzey@westwicke.com
scPharmaceuticals Inc. | |||||||||||||||
Unaudited Consolidated Statements of Operations and Comprehensive Loss | |||||||||||||||
(in thousands, except share and per share data) | |||||||||||||||
THREE MONTHS ENDED SEPTEMBER 30, | NINE MONTHS ENDED SEPTEMBER 30, | ||||||||||||||
2018 | 2019 | 2018 | 2019 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 3,896 | $ | 4,293 | $ | 12,799 | $ | 16,314 | |||||||
General and administrative | 1,945 | 1,996 | 11,645 | 6,158 | |||||||||||
Total operating expenses | 5,841 | 6,289 | 24,444 | 22,472 | |||||||||||
Loss from operations | (5,841 | ) | (6,289 | ) | (24,444 | ) | (22,472 | ) | |||||||
Other (expense) income | (5 | ) | 83 | (58 | ) | 61 | |||||||||
Interest income | 445 | 397 | 1,221 | 1,350 | |||||||||||
Interest expense | (360 | ) | (398 | ) | (1,062 | ) | (1,121 | ) | |||||||
Net loss and comprehensive loss | $ | (5,761 | ) | $ | (6,207 | ) | $ | (24,343 | ) | $ | (22,182 | ) | |||
Net loss per share, basic and diluted | $ | (0.31 | ) | $ | (0.33 | ) | $ | (1.31 | ) | $ | (1.19 | ) | |||
Weighted—average common shares outstanding, basic and diluted | 18,569,289 | 18,584,327 | 18,551,690 | 18,580,192 | |||||||||||
scPharmaceuticals Inc. | ||||||||
Unaudited Consolidated Balance Sheet Data | ||||||||
(in thousands) | ||||||||
DECEMBER 31, 2018 |
SEPTEMBER 30, 2019 |
|||||||
Cash, cash equivalents and restricted cash | $ | 89,660 | $ | 83,744 | ||||
Working capital | 85,220 | 76,783 | ||||||
Total assets | 93,755 | 86,666 | ||||||
Term loan | 9,637 | 18,842 | ||||||
Accumulated deficit | (96,459 | ) | (118,640 | ) | ||||
Total stockholders’ equity | 78,744 | 57,886 |