scPharmaceuticals Inc. - SCPH STOCK NEWS

scPharmaceuticals reported strong Q3 2024 results with FUROSCIX net revenue of $10.0 million, up 164% from Q3 2023 and 24% from Q2 2024. Key achievements include FDA approval for NYHA Class IV patients, positive PK/PD data for Autoinjector program, and completion of $175 million financing. The company filled approximately 10,800 FUROSCIX doses (+16% QoQ) and expanded to 3,100 unique prescribers. However, gross-to-net discount increased to 15.7% from 8% in Q2. The company reported a net loss of $35.1 million ($0.75 per share), with $91.5 million cash on hand as of quarter-end.

scPharmaceuticals (Nasdaq: SCPH) announced it will release its third quarter 2024 financial results on Wednesday, November 13, 2024. The company will host a conference call and audio webcast at 4:30 p.m. ET on the same day to discuss financial results and provide a business update. Participants can join via phone using domestic (1-877-407-9208) or international (1-201-493-6784) numbers with conference code 13749995. A webcast and replay will be available through the company's website.

scPharmaceuticals Inc. (Nasdaq: SCPH) has announced a Key Opinion Leader (KOL) webinar scheduled for October 22, 2024, at 1:00 PM ET. The webinar will focus on a nephrologist's perspective on using FUROSCIX for treating fluid overload in heart failure and its potential use in chronic kidney disease (CKD) patients.

The event will feature Dr. Michael Aaronson from Lincoln Nephrology and Hypertension. The FDA has set a PDUFA target action date of March 6, 2025, for scPharmaceuticals' Supplemental New Drug Application (sNDA) to expand FUROSCIX's indication to include CKD-related fluid overload treatment.

scPharmaceuticals' management will provide updates on long-term growth initiatives, including the FDA-approved expansion of FUROSCIX for NYHA Class IV heart failure patients and the development of a low volume autoinjector. A live Q&A session will follow the presentation.

scPharmaceuticals Inc. (Nasdaq: SCPH), a pharmaceutical company specializing in optimized delivery of infused therapies, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. John Tucker, the company's President & CEO, is scheduled to present on Wednesday, September 11 at 10:00AM ET.

In addition to the presentation, Mr. Tucker will be engaging in investor meetings throughout the day. Interested parties can access a webcast of the presentation via a provided link or through the 'News & Events' section of scPharmaceuticals' official website.

This event provides an opportunity for scPharmaceuticals to showcase its progress in developing products aimed at advancing patient care and reducing healthcare costs through innovative infusion therapy delivery methods.

scPharmaceuticals Inc. (Nasdaq: SCPH) reported strong Q2 2024 financial results and business updates. Key highlights include:

- Net FUROSCIX revenue of $8.1 million, up 33% sequentially from Q1
- Approximately 9,300 FUROSCIX doses filled, a 15% increase from Q1
- Completed financings of up to $175 million, extending cash runway through expected profitability
- FDA approval to expand FUROSCIX indication for NYHA Class IV chronic heart failure patients
- Positive topline PK/PD data for FUROSCIX autoinjector
- FDA acceptance of sNDA for FUROSCIX label expansion to include CKD patients

The company's focus on commercial growth and lifecycle management initiatives positions FUROSCIX as a key part of a new heart failure treatment paradigm.

scPharmaceuticals Inc. (Nasdaq: SCPH) has announced the pricing of a public offering of 12,000,000 shares of common stock at $4.00 per share and pre-funded warrants for up to 500,000 shares at $3.999 per underlying share. The offering aims to raise approximately $50.0 million in gross proceeds. The company has also granted underwriters a 30-day option to purchase up to an additional 1,875,000 shares. The offering, expected to close on August 13, 2024, is being made pursuant to a shelf registration statement. Leerink Partners and TD Cowen are acting as joint book-running managers, with Craig-Hallum as lead manager and Maxim as manager.

scPharmaceuticals Inc. (SCPH) has secured non-dilutive financings totaling up to $125 million with Perceptive Advisors. The deal includes a $75 million senior secured loan and a $50 million revenue interest financing. Key benefits include:

1. Refinancing of existing debt with improved terms
2. Lower interest rate and extended interest-only period
3. Reduced minimum cash requirement to $5 million
4. Additional funding for FUROSCIX commercialization

The revenue interest financing involves tiered single-digit royalties on FUROSCIX global net sales, capped at 1.6x to 2.0x the purchase price. This partnership aims to support FUROSCIX's potential in reducing unnecessary hospital utilization for heart failure patients while generating cost savings for healthcare payers.

scPharmaceuticals (Nasdaq: SCPH) announced FDA approval of its Supplemental New Drug Application for FUROSCIX, expanding its indication to include NYHA Class IV chronic heart failure patients. This expansion covers the most symptomatic patients with the greatest limitation on physical activity, representing about 10% of all heart failure patients nationally.

FUROSCIX is now indicated for treating congestion due to fluid overload in adult patients with chronic heart failure, regardless of NYHA functional class. This approval builds on FUROSCIX's established efficacy and safety profile, potentially preventing heart failure-related hospital admissions or readmissions.

The company views this expansion as a foundation for driving sustained long-term growth, complementing the growing adoption of FUROSCIX among cardiologists and heart failure specialists.

scPharmaceuticals Inc. (SCPH) announced positive topline results from a pharmacokinetic study of SCP-111, an investigational furosemide autoinjector. The study achieved its primary and secondary endpoints, demonstrating 107.3% bioavailability compared to IV furosemide. SCP-111 showed similar urine output and electrolyte excretion to IV furosemide, with minimal pain reported at injection sites. The company aims to submit a Supplemental New Drug Application (sNDA) to the FDA by year-end 2024.

The study involved 21 healthy volunteers aged 45-80 in a randomized, two-way crossover design. If approved, SCP-111 could provide an alternative to the current FUROSCIX on-body infusor, potentially offering greater treatment flexibility for cardiologists and heart failure patients.