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Type C Meeting confirmed that FDA does not believe additional clinical safety, efficacy, or pharmacology studies will be required to support NDA resubmission
Company successfully completed the first of two planned human factors studies
Company accelerates timeline and now expects resubmission of FUROSCIX® NDA with the
Balance sheet remains strong with
“We are encouraged by the most recent interactions with the
Business Highlights
- Received
FDA regulatory update on FUROSCIX. The Company received minutes from the Type C Guidance Meeting held onJune 18, 2019 , between the Company and theFDA , to discuss the Company’s NDA for FUROSCIX, scPharmaceuticals’ lead program for the treatment of congestion in patients with heart failure. As an outcome of the meeting, the Company believes they have confirmed with theFDA that it will not be necessary to conduct additional clinical safety, efficacy, or pharmacology studies as part of its NDA for FUROSCIX. TheFDA further provided recommendations on the Company’s device verification and validation plan for the FUROSCIX Infusor.
- Successfully completed the first of two planned 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 first study was successfully completed and the Company has submitted the protocol for the second study to the
FDA . This human factors study will evaluate the usability of FUROSCIX by patients, caregivers, and healthcare providers. The Company anticipates initiating the second human factors study in the third quarter of 2019.
- FUROSCIX resubmission with the
FDA by mid-year 2020. As a result of the Type C Meeting, scPharmaceuticals is accelerating its timeline and now expects resubmission of the existing FUROSCIX NDA with theFDA by mid-year 2020.
Second 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 second 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 reduce healthcare costs and improve health outcomes. The Company develops, internally and through strategic partnerships, products for 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 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 JUNE 30, | SIX MONTHS ENDED JUNE 30, | ||||||||||||||
2018 | 2019 | 2018 | 2019 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development | $ | 4,855 | $ | 5,496 | $ | 8,903 | $ | 12,020 | |||||||
General and administrative | 5,049 | 1,839 | 9,700 | 4,162 | |||||||||||
Total operating expenses | 9,904 | 7,335 | 18,603 | 16,182 | |||||||||||
Loss from operations | (9,904 | ) | (7,335 | ) | (18,603 | ) | (16,182 | ) | |||||||
Other expense | (11 | ) | (14 | ) | (53 | ) | (22 | ) | |||||||
Interest income | 424 | 463 | 775 | 953 | |||||||||||
Interest expense | (359 | ) | (369 | ) | (701 | ) | (723 | ) | |||||||
Net loss and comprehensive loss | $ | (9,850 | ) | $ | (7,255 | ) | $ | (18,582 | ) | $ | (15,974 | ) | |||
Net loss per share, basic and diluted | $ | (0.53 | ) | $ | (0.39 | ) | $ | (1.00 | ) | $ | (0.86 | ) | |||
Weighted—average common shares outstanding, basic and diluted | 18,549,978 | 18,580,430 | 18,542,745 | 18,578,091 | |||||||||||
scPharmaceuticals Inc. | |||||||||
Unaudited Consolidated Balance Sheet Data | |||||||||
(in thousands) | |||||||||
DECEMBER 31, 2018 | JUNE 30, 2019 | ||||||||
Cash, cash equivalents and restricted cash | $ | 89,660 | $ | 79,649 | |||||
Working capital | 85,220 | 68,241 | |||||||
Total assets | 93,755 | 83,459 | |||||||
Term loan | 9,637 | 9,710 | |||||||
Accumulated deficit | (96,459 | ) | (112,433 | ) | |||||
Total stockholders’ equity | 78,744 | 63,469 |