Biopharma Co. Looks to Expand New Drug Label Down the Road

ScPharmaceuticals Inc. just released topline results from a Phase 2 pilot study supporting the drug developer that is pursuing the expansion of its new drug label, noted an H.C. Wainwright & Co. report.

ScPharmaceuticals Inc. (SCPH:NASDAQ) garnered support for the “value proposition” and future “addition to the label” of its drug Furoscix, from the topline results of AT-HOME, a Phase 2 pilot study in heart failure, reported H.C. Wainwright & Co. analyst Douglas Tsao in a July 13 research note.

Furoscix is under U.S. Food and Drug Administration (FDA) review at present as a treatment of congestion due to fluid overload in adult patients with chronic heart failure, who do not need hospitalizing and who respond suboptimally to oral diuretics.

“We expect approval on the PDUFA date of October 8” (of this year), Tsao commented.

The purpose of the AT-HOME trial was twofold. It was to assess the clinical outcomes and safety of Furoscix against those of “treatment as usual.” This approach typically involves increasing a patient’s oral furosemide dose or adding metolazone to their treatment regimen, Tsao wrote.

The second goal of AT-HOME was to inform the design of a potentially larger study to be used as support for future expansion of Furoscix’s approved uses, noted Tsao. The biopharma plans to meet with the FDA to discuss such a trial.

AT-HOME was not powered to evaluate Furoscix for statistically significant efficacy in chronic heart failure patients, yet its topline results showed just that, versus “treatment as usual,” Tsao pointed out.

Specifically, of note, the analyst relayed that patients treated with Furoscix versus those treated “as usual” exhibited a positive trend in the primary endpoint. It was a 30-day hierarchal composite of cardiovascular death, heart failure hospitalizations, emergency department visits for heart failure, and the percent change in the N terminal-pro hormone BNP from baseline at day seven, as determined using the Finkelstein-Schoenfeld win ratio.

Also, Tsao reported that at day 30 the Furoscix-treated patients had a 37% reduction in the risk of a heart failure-related hospitalization relative to patients who received “treatment as usual.” The Furoscix group also fared better in terms of secondary endpoints, including improvements in congestion, quality of life, and functional status.

In light of these new data, H.C. Wainwright maintained its Buy rating and $15 per share price target on scPharmaceuticals. Its stock today, in comparison, is trading at around $5.08 per share.

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Disclosures for H.C.Wainwright & Co., scPharmaceuticals Inc., July 13, 2022

H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer.

I, Douglas Tsao , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst’s household has a financial interest in the securities of scPharmaceuticals Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of June 30, 2022 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of scPharmaceuticals Inc.. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The firm or its affiliates received compensation from scPharmaceuticals Inc. for non-investment banking services in the previous 12 months.

The Firm or its affiliates did not receive compensation from scPharmaceuticals Inc. for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

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