scPharmaceuticals Provides Business Update

8/13/20

BURLINGTON, Mass.--(BUSINESS WIRE)--scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced financial results for the second quarter ended June 30, 2020 and provided a business update.

Business Update

  • Announced that the U.S. Food and Drug Administration (FDA) has accepted for review the Company’s New Drug Application (NDA) resubmission for FUROSCIX and has set a Prescription Drug User-Fee Act (PDUFA) target action date of December 30, 2020
  • Raised gross proceeds of approximately $53.8 million through an underwritten offering of common stock, bringing the Company’s current cash, cash equivalents, restricted cash, and investments to over $119 million as of June 30, 2020
  • Appointed Sara Bonstein to its Board of Directors, who has 15 years of operational and financial leadership experience in the life sciences industry
  • Selected for inclusion into the Russell 2000 Index
  • Four abstracts accepted for poster presentation at the upcoming Heart Failure Society of America (HFSA) Virtual Annual Scientific Meeting 2020, September 30 through October 6, 2020

“The highlight since our last quarterly update has been the FDA’s acceptance of our FUROSCIX NDA resubmission, and the assignment of our PDUFA date, which is scheduled for December 30,” said John Tucker, president and chief executive officer. “In parallel, the financing that we completed in May, together with cash on-hand, provides us with the resources necessary to build a world-class commercial organization to execute a successful launch of FUROSCIX, if approved. We are pleased with our progress to date, and believe we are on the cusp of introducing a new treatment option for worsening heart failure.”

Second Quarter 2020 Financial Results and Financial Guidance

scPharmaceuticals reported a net loss of $8.3 million for the second quarter of 2020, compared to $7.3 million for the comparable period in 2019.

Research and development expenses were $5.1 million for the second quarter of 2020, compared to $5.5 million for the comparable period in 2019. The decrease in research and development expenses for the quarter ended June 30, 2020 was primarily due to device and drug development costs in 2019 related to the transition to the Company’s next generation drug delivery system, offset by increased clinical development activities, employee-related costs, and regulatory costs in 2020.

General and administrative expenses were $2.5 million for the second quarter of 2020, compared to $1.8 million for the comparable period in 2019. The increase in general and administrative expenses for the quarter ended June 30, 2020 was primarily attributable to employee-related and professional service costs.

scPharmaceuticals ended the second quarter with $119.5 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 in the range of $36.0 to $40.0 million for the fiscal year.

About FUROSCIX

FUROSCIX is a proprietary furosemide solution formulated to a neutral pH to allow for subcutaneous infusion via a wearable, pre-programmed on-body 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 are designed to reduce healthcare costs and improve health outcomes. The Company develops, internally and through strategic partnerships, innovative products and solutions that aim to expand and advance the outpatient care of select acute conditions. The Company’s lead programs focus on the subcutaneous, self-administration of IV-strength treatments in heart failure and infectious disease. scPharmaceuticals is headquartered in Burlington, MA. For more information, please visit www.scPharmaceuticals.com.