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Signed development agreement with
Resubmission of FURSOCIX with the
Balance sheet remains strong with over
“Based on our interactions with the
- Provided regulatory update on FUROSCIX. The Company held a Type C Meeting with the
FDAin January 2019to discuss refiling requirements that were initially discussed in its Type A Post-Action Meeting, held in October 2018. Based on its interactions with the FDAsince June 2018, including clarification on an additional dose validation study and proposed device modifications necessary to advance FUROSCIX using the existing delivery technology, the Company decided to expedite the advancement of a next-generation infusor. The new infusor includes a pre-filled cartridge and other device features expected to address FDAconcerns.
- Announced development agreement with
West Pharmaceutical Servicesfor next-generation FUROSCIX Infusor. On January 29, 2019, the Company signed a development agreement with West Pharmaceutical Services, Inc.(West) to incorporate West’s SmartDose drug delivery system with FUROSCIX. The SmartDose technology platform, previously approved by the FDAfor use in the U.S. with another combination product, offers a wearable, subcutaneous injector with an integrated drug delivery system that adheres to the body for hands-free, outpatient, self-administration, with the potential to improve the overall patient experience with FUROSCIX.
- Completed preliminary feasibility studies with next-generation infusor. scPharmaceuticals recently completed preliminary feasibility studies on the West SmartDose drug delivery system, confirming its ability to successfully deliver the defined volume (10ml) of FUROSCIX. scPharmaceuticals’ feasibility testing included drug stability in the pre-filled cartridge, drug compatibility, and overall performance within FUROSCIX delivery specifications. West has developed this wearable technology with extensive human factors testing and analysis to understand the interaction between the patient and the delivery system.
- Anticipate FUROSCIX NDA to be refiled with the
FDAin 2020. The Company plans to request a meeting with the FDAto define the regulatory path and discuss refiling an NDA for FUROSCIX with the next-generation infusor. The Company anticipates refiling the FUROSCIX NDA in 2020.
Fourth Quarter and Year End 2018 Financial Results and Financial Guidance
scPharmaceuticals reported a net loss of
scPharmaceuticals reported a net loss of
scPharmaceuticals ended the fourth quarter of 2018 with
Based on its current operating plan, scPharmaceuticals forecasts 2019 expenditures of
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.
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
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 to meet with the
|Consolidated Statements of Operations and Comprehensive Loss|
|(in thousands, except share and per share data)|
|THREE MONTHS ENDED
|Research and development||$||3,716||$||3,149||$||14,331||$||15,948|
|General and administrative||2,992||2,074||9,105||13,719|
|Total operating expenses||6,708||5,223||23,436||29,667|
|Loss from operations||(6,708||)||(5,223||)||(23,436||)||(29,667||)|
|Other (expense) income||(7||)||2||75||(56||)|
|Net loss and comprehensive loss||$||(6,880||)||$||(5,100||)||$||(23,817||)||$||(29,443||)|
|Net loss per share, basic and diluted||$||(0.80||)||$||(0.27||)||$||(8.04||)||$||(1.59||)|
|Weighted—average common shares outstanding, basic and diluted||8,565,779||18,569,289||2,962,859||18,556,126|
|Consolidated Balance Sheet Data|
|(in thousands)||AS OF DECEMBER 31,|
|Cash, cash equivalents and restricted cash||$||118,480||$||89,660|
|Total stockholders’ equity||105,997||78,744|