scPharmaceuticals Inc. (SCPH), which closed at a new 52-week high of $8.64 in the last trading session of Feb.14, has two late-stage programs with significant market potential.
scPharmaceuticals is a clinical-stage pharmaceutical company developing products that have the potential to optimize the delivery of infused therapies and reduce health-care costs.
The Company's lead drug candidates include:
-- FUROSCIX, a subcutaneous formulation of Furosemide, the most widely used oral and parenteral diuretic in the treatment of edema associated with congestive heart failure, and -- Subcutaneous formulation of Ceftriaxone, an antibiotic currently used intravenously for the treatment of infections caused by gram-positive and gram-negative organisms.
In June 2018, the FDA had turned down FUROSCIX NDA, indicating the need for additional human factors studies, device modifications, and potentially a clinical validation study.
The resubmission of FUROSCIX New Drug Application, under the current 505(b)(2) approval pathway, with the FDA is expected by mid-year 2020.
According to the Company, FUROSCIX has a market potential of $8 billion in the U.S.
The second lead investigational program, i.e., subcutaneous formulation of Ceftriaxone, has the potential to transform the outpatient antibiotic market, according to scPharma. A pivotal clinical trial for subcutaneous (SC) Ceftriaxone, the results of which were announced in 2016, demonstrated its non-inferiority to IV infusion.
The total addressable market opportunity for Ceftriaxone in the U.S. is estimated to be $4.5 billion in 2021.
The subcutaneous formulation of Ceftriaxone offers a number of benefits like " eliminating the reliance on intravenous catheters/PICC lines, avoiding the need for coordination of home infusion services which often delays discharge, providing patients an alternative to hospitalization or driving to an infusion center daily and is an alternative to suboptimal oral agents (fluoroquinolones)", according to the Company.
Recent Quarterly Scorecard:
The net loss for the third quarter ended September 30, 2019, widened to $6.2 million or $0.33 per share from $5.8 million or $0.31 per share for the comparable period in 2018. No revenue has been generated to date.
The Company ended the third quarter of 2019 with $83.7 million in cash, cash equivalents, and restricted cash.
SCPH has traded in a range of $2.44 to $8.74 in the last 1 year.