Commercialization preparedness activities continuing ahead of December 30 PDUFA date for FUROSCIX® (furosemide injection) for subcutaneous administration
Enrolled first patient in FREEDOM-HF Phase 3 clinical trial
Projected annual net loss for 2020 narrows to $34-37M
#SCPH "announced financial results for the third quarter ended September 30, 2020 and provided a business update.
Continued FUROSCIX commercialization preparedness activities in advance of the company’s December 30, 2020 Prescription Drug User-Fee Act (PDUFA) target action date.
Submitted 12-month drug stability data to the U.S. Food and Drug Administration (FDA). Pursuant to an agreement with the FDA, the company was permitted to submit its New Drug Application (NDA) with nine months of drug stability data and submit the remaining three months of drug stability data during the FDA’s review of the FUROSCIX NDA. All drug stability data has now been submitted.
Participated in three virtual poster presentations at the Heart Failure Society of America Virtual Annual Scientific Meeting 2020.
Hosted a successful Key Opinion Leader webinar. The webinar featured presentations by Dan Bensimhon, M.D. of Cone Health Medical Group and Nihar Desai, M.D., MPH from the Yale School of Medicine who discussed FUROSCIX, the current treatment landscape and the unmet medical need that exists in treating patients with worsening heart failure due to congestion.
Enrolled the first patient in FREEDOM-HF (Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure), a prospective Phase 3 clinical trial evaluating overall and heart failure-related costs for subjects treated with FUROSCIX for 30 days post-discharge from the emergency department compared to patients who remain in the hospital for 24 to 72 hours following hospitalization. Data is expected in the second quarter of 2021 to support the planned commercial launch of FUROSCIX, if approved.
Ended the third quarter with cash, cash equivalents, restricted cash and investments of $114.5 million.
Third Quarter 2020 Financial Results and Financial Guidance
scPharmaceuticals reported a net loss of $9.0 million for the third quarter of 2020, compared to $6.2 million for the comparable period in 2019.
Research and development expenses were $5.1 million for the third quarter of 2020, compared to $4.3 million for the comparable period in 2019. The increase in research and development expenses for the quarter ended September 30, 2020 was primarily due to clinical study activity and employee-related costs, offset by a decrease in device and pharmaceutical development activities.
General and administrative expenses were $3.3 million for the third quarter of 2020, compared to $2.0 million for the comparable period in 2019. The increase was primarily attributable to employee-related and professional service costs, including costs related to commercial preparations.
scPharmaceuticals ended the third quarter with $114.5 million in cash, cash equivalents, restricted cash, and investments, compared to $72.8 million as of December 31, 2019.
Based on its current operating plan, the Company expects the net loss for 2020 to be lower than prior guidance and in the range of $34.0 to $37.0 million for the fiscal year" (see press release HERE).
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