| • | | Patients who received FUROSCIX had a 12.8-point improvement in the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) Summary Score 30 days after study entry. |
| • | | Continued to advance the AT HOME-HF PILOT study evaluating the effectiveness and safety of FUROSCIX versus continued medical therapy in patients with chronic heart failure and fluid overload requiring augmentation in diuretic therapy outside of the hospital. |
| • | | Ended the third quarter with cash, cash equivalents, restricted cash and investments of $85.0 million. |
“Today, we are modestly revising the timing of our FUROSCIX NDA resubmission to Q1 2022, reflecting the impact that COVID-19 has had on our third-party partners, as they have been working to complete the additional device testing as previously requested by the FDA,” stated John Tucker, chief executive officer of scPharmaceuticals. “Importantly, the revised resubmission timeline is not expected to impact our commercial readiness or the anticipated Q4 2022 commercial launch, if approved. We plan to build out world-class commercial and market access teams that I believe can make FUROSCIX the new standard of care in heart failure pre- and post-discharge,” Mr. Tucker concluded.
Third Quarter 2021 Financial Results and Financial Guidance
scPharmaceuticals ended the third quarter with $85.0 million in cash, cash equivalents, restricted cash and investments, compared to $105.3 million as of December 31, 2020. The Company believes its cash, cash equivalents, restricted cash and investments are sufficient to fund operations into 2023.
scPharmaceuticals reported a net loss of $6.6 million for the third quarter of 2021, compared to $9.0 million for the comparable period in 2020.
Research and development expenses were $3.7 million for the third quarter of 2021, compared to $5.1 million for the comparable period in 2020. The decrease in research and development expenses for the quarter ended September 30, 2021 was primarily due to a decrease in device and pharmaceutical development costs, partially offset by an increase in quality and regulatory consulting costs.
General and administrative expenses were $2.2 million for the third quarter of 2021, compared to $3.3 million for the comparable period in 2020. The decrease in general and administrative expenses for the quarter ended September 30, 2021 was primarily due to a decrease in employee related, commercial preparation, and legal costs.
Based on its current operating plan, the Company expects a net loss for 2021 to be in the range of $29.0 to $31.0 million for the fiscal year, a decrease over prior guidance of $30.0 to $34.0 million.
About FUROSCIX® (furosemide injection) for subcutaneous injection
FUROSCIX is an investigational, proprietary furosemide solution formulated to a neutral pH, designed to allow for subcutaneous infusion via a wearable, pre-programmed on-body drug delivery system, for outpatient self-administration. FUROSCIX is currently under development for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure who display reduced responsiveness to oral diuretics and who do not require hospitalization. If approved, FUROSCIX has the potential to provide an outpatient alternative for the treatment of heart failure due to congestion.