BURLINGTON, Mass. - scPharmaceuticals Inc. (NASDAQ:SCPH), a pharmaceutical company, announced positive results from a study of SCP-111, its investigational autoinjector designed to deliver furosemide subcutaneously, offering an alternative to the FDA-approved FUROSCIX on-body infusor. The study met primary pharmacokinetic and secondary pharmacodynamic endpoints.
The open-label, single-center, randomized crossover study involved 21 healthy volunteers aged 45 to 80. It compared the bioavailability of SCP-111 with intravenous (IV) furosemide. SCP-111 demonstrated a bioavailability of 107.3%, within the acceptable range. Participants showed comparable urine output and electrolyte excretion to IV furosemide, with a median pain score of 0 at all time points.
The most common adverse events were localized to the injection site, while systemic adverse events were consistent with known effects of IV and oral furosemide. CEO John Tucker expressed optimism about the submission of a Supplemental New Drug Application (sNDA) to the FDA by the end of 2024, anticipating that SCP-111 could provide treatment flexibility for cardiologists, heart failure specialists, and patients.
The company plans to present the full data set at a future medical meeting or in a publication. This announcement is based on a press release statement. The information presented is subject to further verification, and the potential approval of SCP-111 will depend on the outcomes of ongoing clinical trials and regulatory review processes.
In other recent news, scPharmaceuticals has secured a significant financing deal, announced an FDA-approved expansion for FUROSCIX, and reported Q1 2024 financials. The biopharmaceutical company has secured up to $125 million in financing through debt and royalty agreements with Perceptive Advisors. This funding will support the commercialization of FUROSCIX, a treatment for fluid overload in heart failure patients.
In a significant development, the FDA has approved the expansion of FUROSCIX to include treatment for all classes of chronic heart failure patients. The company has also submitted a Supplemental New Drug Application (sNDA) for FUROSCIX, seeking to expand its indication to treat edema due to fluid overload in patients with chronic kidney disease.
scPharmaceuticals has also announced plans for a public offering of its common stock, managed by Leerink Partners and TD Cowen, subject to market conditions. The company reported Q1 2024 net revenue of $6.1 million and a net loss of $14.1 million, with cash and cash equivalents of $58.4 million, despite a cyber-attack resulting in a 10% loss of doses. These are the recent developments for the company.
InvestingPro Insights
As scPharmaceuticals Inc. (NASDAQ:SCPH) continues to make strides in the development of SCP-111, offering a promising alternative to traditional furosemide administration, investors may be interested in the company's financial health and market performance.
According to InvestingPro data, scPharmaceuticals holds a market capitalization of $156.12 million, with a significant revenue growth over the last twelve months as of Q1 2024, at an impressive rate of 754.68%. This substantial increase in revenue may reflect the company’s potential in capturing market share with its innovative treatments.
Despite the promising developments, scPharmaceuticals is not yet profitable, as indicated by a negative P/E ratio of -2.97. This is further corroborated by an InvestingPro Tip, noting that analysts do not expect the company to be profitable this year.
Nonetheless, another positive aspect for the company is its liquidity position; scPharmaceuticals holds more cash than debt on its balance sheet and has liquid assets that exceed short-term obligations. This financial stability could provide the cushion needed to support ongoing research and development activities, such as those for SCP-111.
While the company's stock has seen a year-to-date price total return of -30.94%, indicating some volatility, it is important for interested parties to consider the long-term potential of the company's pipeline. Investors seeking more detailed analysis can find additional InvestingPro Tips for scPharmaceuticals, which offer deeper insights into the company's financial metrics and market expectations. There are currently 7 more InvestingPro Tips available at https://www.investing.com/pro/SCPH, which could help investors make more informed decisions.
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