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Type C Meeting to solidify re-filing plans for FUROSCIX® scheduled with the
Resubmission of FURSOCIX New Drug Application (NDA) with the
Balance sheet remains strong with over
“We enter 2019 with good momentum and an increasingly clear line of sight on what we need to accomplish to refile our NDA for FUROSCIX in 2020,” said
Business Highlights
- Regulatory update on FUROSCIX. The Company submitted a meeting package to the
FDA and has scheduled a Type C Meeting that will take place inJune 2019 . This Type C Meeting will be the first meeting the Company has had with theFDA since the Company elected to expedite the advancement of a next-generation infusor, which includes a pre-filled cartridge and other device features expected to address priorFDA requirements. The Company believes the upcoming meeting with theFDA will solidify plans for the refiling of FUROSCIX in 2020. FUROSCIX is scPharmaceuticals’ lead product being developed for the treatment of congestion, or fluid overload, in patients with heart failure.
- The Company plans to initiate and complete first human factors study in the second quarter of 2019. On
January 29, 2019 , the Company signed a development agreement with West to incorporate West’s SmartDose drug delivery system with the Company’s subcutaneous formulation of furosemide, as the FUROSCIX Infusor. As part of the transition to the SmartDose system, the Company is required to conduct a series of human factors studies under the current 505(b)(2) approval pathway for FUROSCIX. The human factors studies are designed to evaluate FUROSCIX’s use in a real world setting to determine if the product is being used correctly and safely by the intended users of the product. The Company plans to include the outcome of the human factors studies in the NDA resubmission.
- Filed provisional patent of FUROSCIX that could extend protection through 2040. The Company recently filed a provisional composition of matter patent on a liquid pharmaceutical formulation containing an increased concentration of furosemide. Additional method patents were filed on ways of treating congestion, fluid overload, or hypertension using these formulations of furosemide. Development work around a new, increased concentration of furosemide in FUROSCIX offers the potential to enable greater dosing flexibility.
First 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 first quarter of 2019 with
Based on its current operating plan, scPharmaceuticals continues to forecast 2019 expenditures of
About FUROSCIX
FUROSCIX is a proprietary furosemide solution formulated to a neutral pH to allow for subcutaneous infusion via a wearable, subcutaneous infusor 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 clinical-stage 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 advancement of, and potential timing of regulatory filings for, FUROSCIX with the West SmartDose drug delivery system as a next-generation infusor technology; the Company’s plans with respect to its Type C Meeting 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 MARCH 31, |
|||||||
2018 | 2019 | ||||||
Operating expenses: | |||||||
Research and development | $ | 4,048 | $ | 6,524 | |||
General and administrative | 4,651 | 2,323 | |||||
Total operating expenses | 8,699 | 8,847 | |||||
Loss from operations | (8,699 | ) | (8,847 | ) | |||
Other expense | (42 | ) | (8 | ) | |||
Interest income | 351 | 490 | |||||
Interest expense | (342 | ) | (354 | ) | |||
Net loss and comprehensive loss | $ | (8,732 | ) | $ | (8,719 | ) | |
Net loss per share, basic and diluted | $ | (0.47 | ) | $ | (0.47 | ) | |
Weighted—average common shares outstanding, basic and diluted | 18,535,432 | 18,575,726 |
scPharmaceuticals Inc. | |||||||
Unaudited Consolidated Balance Sheet Data | |||||||
(in thousands) |
|||||||
DECEMBER 31, 2018 |
MARCH 31, 2019 | ||||||
Cash, cash equivalents and restricted cash | $ | 89,660 | $ | 83,560 | |||
Working capital | 85,220 | 75,715 | |||||
Total assets | 93,755 | 87,587 | |||||
Term loan | 9,637 | 9,684 | |||||
Accumulated deficit | (96,459 | ) | (105,178 | ) | |||
Total stockholders’ equity | 78,744 | 70,398 |