Duyuru • Oct 18
scPharmaceuticals Inc. Files Form 15 scPharmaceuticals Inc. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its Common Stock under the Securities Exchange Act of 1934, as amended. The par value of the company's Common Stock was $0.0001 per share. Duyuru • Oct 09
scPharmaceuticals Inc.(NasdaqGM:SCPH) dropped from NASDAQ Composite Index scPharmaceuticals Inc. has been dropped from the NASDAQ Composite Index . Duyuru • Oct 08
MannKind Corporation (NasdaqGM:MNKD) completed the acquisition of scPharmaceuticals Inc. (NasdaqGS:SCPH). MannKind Corporation (NasdaqGM:MNKD) entered into a definitive Agreement to acquire scPharmaceuticals Inc. (NasdaqGS:SCPH) for approximately $290 million on August 24, 2025. As part of agreement, MannKind Corporation will commence a tender offer to acquire all of the outstanding shares of scPharmaceuticals's common stock, at a price per share of (i) $5.35 in cash, without interest, subject to any applicable withholding taxes and (ii) one non-tradeable contingent value right (CVR), which represents the right to receive certain milestone payments of up to an aggregate of $1.00 in cash, payable upon achieving specific regulatory and net sales milestones. In case of termination of transaction, scPharmaceuticals will pay a termination fee of $9.48 million. Under the terms of the definitive merger agreement, MannKind will promptly commence a tender offer to acquire all of the outstanding shares of scPharmaceuticals. MannKind and Blackstone amended their recently announced strategic financing agreement to provide $175 million of additional funding to support the acquisition.
The transaction is subject to approval by regulatory board / committee, minimum tender and all applicable waiting periods under the HSR Act and the Required Antitrust Approvals shall have expired or been terminated and any approvals or clearances required thereunder shall have been obtained. The board of directors of the scPharmaceuticalst unanimously recommends that stockholders accept the Offer. The deal has been unanimously approved by the boards of MannKind Corporation and scPharmaceuticals. The transaction is expected to complete in fourth quarter of 2025. As on October 6, 2025, the tender offer expired and pursuant to the offer 73.47% shares where validly tendered.
Jefferies LLC acted as financial advisor for MannKind Corporation. The team of Cooley LLP led by Barbara Borden, Rowook Park, Julia Kim, Mischi a Marca and Adam Longenbach acted as legal advisor for MannKind Corporation. Leerink Partners LLC acted as financial advisor for scPharmaceuticals Inc. The team of Latham & Watkins LLP led by Wesley Holmes, Scott Shean, Bret Stancil, Elisabeth Martin, Peter Handrinos, Alexandra McArthur, Josh Friedman, Katharine Moir, Betty Pang, Chad Jennings, Elizabeth Ohacted, Heather Deixler, Patrick English, Kristin Murphy and Steven Chinowsky as legal advisor for scPharmaceuticals Inc.
MannKind Corporation (NasdaqGM:MNKD) completed the acquisition of scPharmaceuticals Inc. (NasdaqGS:SCPH) on October 7, 2025. Duyuru • Aug 25
MannKind Corporation (NasdaqGM:MNKD) entered into a definitive agreement to acquire scPharmaceuticals Inc. (NasdaqGS:SCPH) for approximately $290 million. MannKind Corporation (NasdaqGM:MNKD) entered into a definitive agreement to acquire scPharmaceuticals Inc. (NasdaqGS:SCPH) for approximately $290 million on August 24, 2025. As part of agreement, MannKind Corporation will commence a tender offer to acquire all of the outstanding shares of scPharmaceuticals's common stock, at a price per share of (i) $5.35 in cash, without interest, subject to any applicable withholding taxes and (ii) one non-tradeable contingent value right (CVR), which represents the right to receive certain milestone payments of up to an aggregate of $1.00 in cash, payable upon achieving specific regulatory and net sales milestones. In case of termination of transaction, scPharmaceuticals will pay a termination fee of $9.48 million. Under the terms of the definitive merger agreement, MannKind will promptly commence a tender offer to acquire all of the outstanding shares of scPharmaceuticals. MannKind and Blackstone amended their recently announced strategic financing agreement to provide $175 million of additional funding to support the acquisition.
The transaction is subject to approval by regulatory board / committee, minimum tender and all applicable waiting periods under the HSR Act and the Required Antitrust Approvals shall have expired or been terminated and any approvals or clearances required thereunder shall have been obtained. The board of directors of the scPharmaceuticalst unanimously recommends that stockholders accept the Offer. The deal has been unanimously approved by the boards of MannKind Corporation and scPharmaceuticals. The transaction is expected to complete in fourth quarter of 2025.
Jefferies LLC acted as financial advisor for MannKind Corporation. Barbara Borden and Rowook Park of Cooley LLP acted as legal advisor for MannKind Corporation. Leerink Partners LLC acted as financial advisor for scPharmaceuticals Inc. Scott Shean, Wesley Holmes and Bret Stancil of Latham & Watkins LLP acted as legal advisor for scPharmaceuticals Inc. Duyuru • Aug 14
scPharmaceuticals Inc. Receives Notice of Allowances of Multiple US Patent Applications Covering SCP-111 scPharmaceuticals Inc. announced that it has received five Notices of Allowance from the United States Patent and Trademark Office (USPTO) for patent applications covering their latest furosemide formulation, SCP-111. The SCP-111 formulation is the subject of a supplemental NDA expected to be filed by the Company this quarter. The five patents, once issued, will join four additional patents owned by the Company that cover the SCP-111 formulation. Duyuru • Aug 01
scPharmaceuticals Inc. to Report Q2, 2025 Results on Aug 07, 2025 scPharmaceuticals Inc. announced that they will report Q2, 2025 results After-Market on Aug 07, 2025 Duyuru • May 08
scPharmaceuticals Inc. to Report Q1, 2025 Results on May 14, 2025 scPharmaceuticals Inc. announced that they will report Q1, 2025 results After-Market on May 14, 2025 Duyuru • Apr 22
scPharmaceuticals Inc., Annual General Meeting, Jun 03, 2025 scPharmaceuticals Inc., Annual General Meeting, Jun 03, 2025. Duyuru • Mar 13
scPharmaceuticals Inc. to Report Q4, 2024 Results on Mar 19, 2025 scPharmaceuticals Inc. announced that they will report Q4, 2024 results at 4:00 PM, US Eastern Standard Time on Mar 19, 2025 Duyuru • Mar 07
scPharmaceuticals Announces FDA Approval of Supplemental New Drug Application Expanding the FUROSCIX®? Indication to Include the Treatment of Edema in Patients with Chronic Kidney Disease scPharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) for FUROSCIX®? to expand the indication to include treatment of edema in patients with chronic kidney disease (CKD). FUROSCIX (furosemide injection), 80 mg/10 mL for subcutaneous use is indicated for the treatment of edema (i.e., congestion, fluid overload, or hypervolemia) in adult patients with chronic heart failure or chronic kidney disease (CKD), including the nephrotic syndrome. Duyuru • Jan 11
scPharmaceuticals Inc. Provides Preliminary FUROSCIX Net Revenue Guidance for the Fourth Quarter and Full Year 2024 scPharmaceuticals Inc. provided preliminary FUROSCIX net revenue guidance for the fourth quarter and full year 2024. The company expected preliminary unaudited fourth quarter FUROSCIX net revenue to be in the range of $12.0 million to $12.3 million, representing a 22% increase from the third quarter of 2024 at the mid-point of the range.
Preliminary unaudited full year 2024 FUROSCIX net revenue is expected to be in the range of $36.2 million to $36.5 million, representing 167% growth over the full year 2023 at the mid-point of the range. Reported Earnings • Nov 14
Third quarter 2024 earnings released: US$0.75 loss per share (vs US$0.40 loss in 3Q 2023) Third quarter 2024 results: US$0.75 loss per share (further deteriorated from US$0.40 loss in 3Q 2023). Revenue: US$10.0m (up 164% from 3Q 2023). Net loss: US$35.1m (loss widened 125% from 3Q 2023). Revenue is forecast to grow 45% p.a. on average during the next 3 years, compared to a 3.5% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has fallen by 18% per year but the company’s share price has only fallen by 7% per year, which means it has not declined as severely as earnings. Duyuru • Nov 07
scPharmaceuticals Inc. to Report Q3, 2024 Results on Nov 13, 2024 scPharmaceuticals Inc. announced that they will report Q3, 2024 results on Nov 13, 2024 Reported Earnings • Aug 15
Second quarter 2024 earnings released: US$0.44 loss per share (vs US$0.37 loss in 2Q 2023) Second quarter 2024 results: US$0.44 loss per share (further deteriorated from US$0.37 loss in 2Q 2023). Revenue: US$8.05m (up 392% from 2Q 2023). Net loss: US$17.1m (loss widened 21% from 2Q 2023). Revenue is forecast to grow 45% p.a. on average during the next 3 years, compared to a 3.7% growth forecast for the Pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has fallen by 13% per year but the company’s share price has increased by 1% per year, which means it is well ahead of earnings. New Risk • Aug 14
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 34% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (14% average weekly change). Minor Risk Shareholders have been diluted in the past year (34% increase in shares outstanding). Duyuru • Aug 12
scPharmaceuticals Inc. has filed a Follow-on Equity Offering. scPharmaceuticals Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Pre-funded Warrants
Security Type: Equity Warrant Duyuru • Jul 25
scPharmaceuticals Announces Filing Acceptance of Supplemental New Drug Application (sNDA) Seeking to Expand FUROSCIX Indication to Include Chronic Kidney Disease scPharmaceuticals Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Supplemental New Drug Application (sNDA) seeking to expand the FUROSCIX indication to include treatment of edema due to fluid overload in patients with chronic kidney disease (CKD). The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of March 6, 2025. In Type D meeting feedback provided by the FDA last year, the agency confirmed that no additional clinical studies would be needed to expand the indication, provided that the Company is able to demonstrate an adequate pharmacokinetic (PK) and pharmacodynamic (PD) bridge to the listed drug, furosemide injection, 10 mg/mL. FUROSCIX® (furosemide injection) 80 mg/10mL for subcutaneous use: FUROSCIX® is indicated for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure. FUROSCIX is not indicated for use in emergency situations or in patients with acute pulmonary edema. The On-Body Infusor will deliver only an 80-mg dose of FUROSCIX. IMPORTANT SAFETY INFORMATION: FUROSCIX is contraindicated in patients with anuria, patients with a history of hypersensitivity to furosemide or medical adhesives and in patients with hepatic cirrhosis or ascites. Furosemide may cause fluid, electrolyte, and metabolic abnormalities, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy. Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients. In patients with hepatic cirrhosis and ascites, sudden alterations of fluid and electrolyte balance may precipitate hepatic encephalopathy and coma. Treatment in such patients is best initiated in the hospital. Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, furosemide should be discontinued. Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported with furosemide. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs. In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. These patients require careful monitoring, especially during the initial stages of treatment. The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain. New Risk • May 15
New minor risk - Financial position The company has less than a year of cash runway based on its current free cash flow. Free cash flow: -US$60m This is considered a minor risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Minor Risks Less than 1 year of cash runway based on current free cash flow (-US$60m). Share price has been volatile over the past 3 months (8.4% average weekly change). Duyuru • May 09
scPharmaceuticals Inc. to Report Q1, 2024 Results on May 14, 2024 scPharmaceuticals Inc. announced that they will report Q1, 2024 results on May 14, 2024 Duyuru • Apr 28
scPharmaceuticals Inc., Annual General Meeting, Jun 11, 2024 scPharmaceuticals Inc., Annual General Meeting, Jun 11, 2024, at 12:30 US Eastern Standard Time. Agenda: To elect three Class I directors, namely Frederick Hudson, Leonard D. Schaeffer and Sara Bonstein, each to hold office until the 2027 annual meeting of stockholders and until their successor is duly elected and qualified, or until their earlier death, resignation or removal; to ratify the appointment of RSM US LLP as company's independent registered public accounting firm for the fiscal year ending December 31, 2024; to approve, on an advisory (non-binding) basis, the compensation of company's named executive officers; to approve an amendment to the Second Amended and Restated Certificate of Incorporation to provide for the exculpation of officers from certain breaches of fiduciary duty to the extent permitted by the General Corporation Law of the State of Delaware; and to transact any other business that properly comes before the Annual Meeting (including any continuation, adjournment or postponement thereof). Board Change • Apr 25
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 9 experienced directors. 3 highly experienced directors. Independent Director William Abraham was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Duyuru • Apr 25
scPharmaceuticals Inc. Announces First Participant Enrolled in Pivotal Pharmacokinetic Study of Furoscix Auto-Injector (Furosemide 80Mg/Ml) Injection scPharmaceuticals Inc. announced that it has enrolled the first participant in the pivotal pharmacokinetic (PK) study of SCP-111 (furosemide 80 mg/mL), an investigational, low volume, pH neutral formulation of furosemide administered via an auto-injector. The auto-injector is being developed as a complement to the FDA approved On-body Infusor in an effort to provide patients with a subcutaneous injection and prescribers with treatment flexibility. If approved, the Company believes the auto-injector also has the potential to meaningfully reduce manufacturing costs. Breakeven Date Change • Mar 27
Forecast to breakeven in 2026 The 6 analysts covering scPharmaceuticals expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 31% per year to 2025. The company is expected to make a profit of US$39.9m in 2026. Average annual earnings growth of 60% is required to achieve expected profit on schedule. Duyuru • Mar 14
scPharmaceuticals Inc. has filed a Follow-on Equity Offering in the amount of $50 million. scPharmaceuticals Inc. has filed a Follow-on Equity Offering in the amount of $50 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Duyuru • Mar 07
scPharmaceuticals Inc. to Report Q4, 2023 Results on Mar 13, 2024 scPharmaceuticals Inc. announced that they will report Q4, 2023 results on Mar 13, 2024 Duyuru • Jan 05
scPharmaceuticals Inc. Provides Revenue Guidance for the Full Year 2023 scPharmaceuticals Inc. provided revenue guidance for the full year 2023. For the period, the company anticipates net revenue to be in a range of $13.4 million to $13.6 million. Breakeven Date Change • Dec 31
Forecast to breakeven in 2026 The 6 analysts covering scPharmaceuticals expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$42.4m in 2026. Average annual earnings growth of 57% is required to achieve expected profit on schedule. Duyuru • Nov 02
scPharmaceuticals Inc. to Report Q3, 2023 Results on Nov 08, 2023 scPharmaceuticals Inc. announced that they will report Q3, 2023 results on Nov 08, 2023 New Risk • Nov 02
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of German stocks, typically moving 6.3% a week. This is considered a minor risk. Share price volatility indicates the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. It also increases the risk of potential losses in the short term as the stock tends to have larger drops in price more frequently than other stocks. Currently, the following risks have been identified for the company: Minor Risks Share price has been volatile over the past 3 months (6.3% average weekly change). Shareholders have been diluted in the past year (31% increase in shares outstanding). Revenue is less than US$5m (US$3.7m revenue). Duyuru • Sep 20
Scpharmaceuticals Announces Positive Feedback from Two Fda Meetings on Key Long-Term Growth Initiatives scPharmaceuticals Inc. announced that the Company has received positive feedback from the U.S. Food and Drug Administration (FDA) on two key long-term growth initiatives. The Company announced FDA feedback from a Type C meeting pertaining to the development of an 80mg/1mL auto-injector intended to provide an additional option to the on-body infusor for treatment of congestion due to fluid overload in eligible adult patients who do not require hospitalization. The Company expects that an auto-injector, if successfully developed and approved, would reduce manufacturing costs compared to the current on-body infusor and confer environmental advantages. scPharmaceuticals plans to report data from a pivotal pharmacokinetic (PK) study in first half of 2024, and, if successful, targets submitting a Supplemental New Drug Application (sNDA) to the FDA by the end of 2024. The Company also announced feedback from a Type D meeting with the FDA pertaining to the potential expansion of the FUROSCIX label to include treatment of edema due to fluid overload in patients with CKD. In its feedback, the FDA confirmed that no additional clinical studies are needed to expand the indication, provided that the Company demonstrates an adequate PK and pharmacodynamic bridge to the listed drug, furosemide injection, 10 mg/mL. CKD is a progressive disease characterized by worsening renal function over time, resulting in frequent episodes of fluid overload that are treated with loop diuretics. Breakeven Date Change • Aug 11
Forecast to breakeven in 2025 The 5 analysts covering scPharmaceuticals expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$4.74m in 2025. Average annual earnings growth of 70% is required to achieve expected profit on schedule. Duyuru • Aug 04
scPharmaceuticals Inc. to Report Q2, 2023 Results on Aug 10, 2023 scPharmaceuticals Inc. announced that they will report Q2, 2023 results on Aug 10, 2023 Duyuru • Aug 03
scPharmaceuticals Announces Positive Type C Meeting Feedback from FDA on Potential Heart Failure Class IV Indication Expansion scPharmaceuticals Inc. announced that the Company has received positive Type C meeting feedback from the US Food and Drug Administration (FDA) regarding the potential expansion of the FUROSCIX(R) indication to allow for use in New York Heart Association (NYHA) Class IV heart failure patients. FUROSCIX is currently indicated for the treatment of congestion due to fluid overload in adult patients with NYHA Class II and Class III chronic heart failure. The Company also announced the issuance of U.S. patents covering concentrated formulations of furosemide. This enables the possibility of developing additional furosemide formulations for subcutaneous administration that will provide clinicians with additional dosing flexibility. The Company has completed initial solubility and stability studies on multiple formulations described in the patent properties, has identified potential product candidates, and commenced IND enabling studies. scPharmaceuticals has additional U.S. patent applications pending that cover various methods of use of such or similar formulations of furosemide for treatment of congestion in patients with heart failure and edema in patients with kidney disease. The Company is also pursuing similar patent protection outside of the United States. Board Change • Aug 01
Insufficient new directors There is 1 new director who has joined the board in the last 3 years. The company's board is composed of: 1 new director. 9 experienced directors. 2 highly experienced directors. Independent Director William Abraham was the last director to join the board, commencing their role in 2021. The company’s insufficient board refreshment is considered a risk according to the Simply Wall St Risk Model. Breakeven Date Change • May 12
Forecast to breakeven in 2025 The 5 analysts covering scPharmaceuticals expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$8.77m in 2025. Average annual earnings growth of 76% is required to achieve expected profit on schedule. Breakeven Date Change • May 03
Forecast to breakeven in 2025 The 5 analysts covering scPharmaceuticals expect the company to break even for the first time. New consensus forecast suggests losses will reduce by 2.9% per year to 2024. The company is expected to make a profit of US$11.3m in 2025. Average annual earnings growth of 60% is required to achieve expected profit on schedule. Breakeven Date Change • Mar 24
No longer forecast to breakeven The 5 analysts covering scPharmaceuticals no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$2.85m in 2025. New consensus forecast suggests the company will make a loss of US$517.8k in 2025. Duyuru • Jan 31
scPharmaceuticals Provides FUROSCIX® (furosemide injection) Commercial Update scPharmaceuticals Inc. announced that the company is targeting February 20, 2023 as the date for commercial availability of FUROSCIX® (furosemide injection), a proprietary formulation of furosemide delivered via an On-Body Infusor for outpatient treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure. FUROSCIX is not indicated for emergency situations or in patients with acute pulmonary edema. FUROSCIX Infusor will deliver only an 80-mg dose. FUROSCIX® is indicated for the treatment of congestion due to fluid overload in adult patients with New York Heart Association (NYHA) Class II and Class III chronic heart failure. FUROSCIX is not indicated for use in emergency situations or in patients with acute pulmonary edema. FUROSCIX Infusor will deliver only an 80-mg dose. Furosemide may cause fluid, electrolyte, and metabolic abnormalities, particularly in patients receiving higher doses, patients with inadequate oral electrolyte intake, and in elderly patients. Serum electrolytes, CO2, BUN, creatinine, glucose, and uric acid should be monitored frequently during furosemide therapy. Excessive diuresis may cause dehydration and blood volume reduction with circulatory collapse and possibly vascular thrombosis and embolism, particularly in elderly patients. In patients with hepatic cirrhosis and ascites, sudden alterations of fluid and electrolyte balance may precipitate hepatic encephalopathy and coma. Treatment in such patients is best initiated in the hospital. Furosemide can cause dehydration and azotemia. If increasing azotemia and oliguria occur during treatment of severe progressive renal disease, furosemide should be discontinued. Cases of tinnitus and reversible or irreversible hearing impairment and deafness have been reported with furosemide. Reports usually indicate that furosemide ototoxicity is associated with rapid injection, severe renal impairment, the use of higher than recommended doses, hypoproteinemia or concomitant therapy with aminoglycoside antibiotics, ethacrynic acid, or other ototoxic drugs. In patients with severe symptoms of urinary retention (because of bladder emptying disorders, prostatic hyperplasia, urethral narrowing), the administration of furosemide can cause acute urinary retention related to increased production and retention of urine. These patients require careful monitoring, especially during the initial stages of treatment. The most common adverse reactions with FUROSCIX administration in clinical trials were site and skin reactions including erythema, bruising, edema, and injection site pain. Breakeven Date Change • Dec 31
Forecast to breakeven in 2025 The 5 analysts covering scPharmaceuticals expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$2.97m in 2025. Average annual earnings growth of 61% is required to achieve expected profit on schedule. Duyuru • Dec 20
scPharmaceuticals Inc. Announces Appointment of Rachael Nokes as Chief Financial Officer scPharmaceuticals Inc. announced the appointment of Rachael Nokes as Chief Financial Officer. Ms. Nokes previously served as scPharmaceuticals’ Senior Vice President of Finance. Ms. Nokes is a senior financial executive with more than 20 years of experience, primarily in the life science industry. She joined scPharmaceuticals in 2014 from BG Medicine Inc., a publicly traded medical device company, where she was Director of Accounting. At BG Medicine, Ms. Nokes had significant responsibilities related to securing and managing several rounds of financing from various venture capital and other funding sources, culminating in the company’s initial public offering in early 2011. She was also instrumental in transitioning the finance organization from a privately held model to one capable of meeting the requirements for publicly traded entities, including SEC reporting and the implementation of Sarbanes Oxley. Prior to BG Medicine, Rachael held positions within Oak Industries Inc., a publicly traded supplier of components to the communications industry, and PriceWaterhouseCoopers, where she began her career as an auditor. She received a B.S. in Accounting from the Carroll School of Management at Boston College and an M.S. in Finance from Bentley University. Duyuru • Nov 24
scPharmaceuticals Inc. has completed a Follow-on Equity Offering in the amount of $50.003345 million. scPharmaceuticals Inc. has completed a Follow-on Equity Offering in the amount of $50.003345 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 6,620,000
Price\Range: $5.25
Discount Per Security: $0.315
Security Name: Prefunded Warrants
Security Type: Equity Warrant
Securities Offered: 2,905,000
Price\Range: $5.249
Discount Per Security: $0.315 Duyuru • Nov 10
scPharmaceuticals Inc. Revises Earnings Guidance for the Year 2022 scPharmaceuticals Inc. revised earnings guidance for the year 2022. Based on its current operating plan, the Company has adjusted its 2022 net loss to $38 to $41 million, a decrease over prior guidance of $43 to $48 million. Duyuru • Oct 27
scPharmaceuticals Inc. to Report Q3, 2022 Results on Nov 09, 2022 scPharmaceuticals Inc. announced that they will report Q3, 2022 results on Nov 09, 2022 Duyuru • Jul 13
scPharmaceuticals Inc. Announces Positive Results from the at Home-HF Phase 2 Pilot Study in Heart Failure scPharmaceuticals Inc. announced positive results from the AT HOME-HF Pilot study, a Phase 2, multicenter, randomized study that compared scPharmaceuticals’ investigational product, FUROSCIX (furosemide 80 mg/10 mL for subcutaneous administration), with a “treatment as usual” approach in chronic heart failure patients presenting to a heart failure clinic with worsening congestion and requiring augmented diuresis. The study enrolled 51 subjects, of which 34 received FUROSCIX and 17 received “treatment as usual.” There was a positive trend in the Finkelstein-Schoenfeld win ratio of the hierarchal primary composite endpoint consisting of cardiovascular death, heart failure hospitalizations, emergency department visits for heart failure and % change from baseline of NT-proBNP at day seven in the FUROSCIX group compared to the “treatment as usual” group across multiple analysis populations. Subjects randomized to FUROSCIX had a 37% reduction in the risk of a heart failure hospitalization relative to patients randomized to “treatment as usual” at day 30. All pre-defined secondary endpoints measuring symptoms of congestion, quality of life and functional status favored the FUROSCIX group and included a two kilogram greater weight loss at day three and a 12-point increase in the 12 item Kansas City Cardiomyopathy Questionnaire (KCCQ-12) summary scores at day 7 and day 30. There were 11 subjects that experienced 21 adverse events during the 30-day study period that were determined by the investigator to be related to FUROSCIX. The most common related adverse event was infusion site pain that was mild in severity. There was one serious adverse event (dehydration) that was assessed by the investigator as possibly related to FUROSCIX, which resolved. During the 30-day study period, there was one death (sudden cardiac death) in the FUROSCIX group which occurred on study day 30 and was assessed by the investigator to be not related to FUROSCIX. Duyuru • Apr 12
scPharmaceuticals Inc. Announces Resubmission of Furoscix® New Drug Application scPharmaceuticals Inc. announced that the company has resubmitted its New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking marketing approval for FUROSCIX for the treatment of decompensated heart failure. In addition, West Pharmaceutical Services Inc. has completed all development activities and submitted the Device Master File in support of the FUROSCIX NDA. The company is advancing its commercial readiness activities in anticipation of a potential Fourth Quarter commercial launch, if approved. These include: Finalizing physician, payer and pricing research; Communicating FUROSCIX data, including FREEDOM-HF data, to pharmacy benefit managers and health plans through its product dossier; Finalizing FUROSCIX distribution partners; and Reinitiating commercial staffing to support anticipated Fourth Quarter 2022 launch, if approved. Duyuru • Sep 11
scPharmaceuticals Inc. Presents Late-breaking FREEDOM-HF Study Data at the Heart Failure Society of America Annual Scientific Meeting 2021 scPharmaceuticals Inc. announced that data from its recently-completed FREEDOM-HF clinical trial will be presented at the Heart Failure Society of America (HFSA) Annual Scientific Meeting 2021. In the FREEDOM-HF study, heart failure (HF) patients with mild to moderate volume overload (despite oral diuretic use) and treated with subcutaneous FUROSCIX were successfully managed in the outpatient setting resulting in significantly reduced HF-related and overall healthcare costs through reduction of HF-related hospitalizations and rehospitalizations. Following its Type-C meeting with the FDA in June, aligned with the agency on the regulatory path forward, are well financed with more than $90 million on hand as of June 30, 2021, and remain on track to re-submit New Drug Application (NDA) in the fourth quarter of this year. Duyuru • Aug 12
scPharmaceuticals Inc. Provides Earnings Guidance for the Year 2021 scPharmaceuticals Inc. provided earnings guidance for the year 2021. Based on its current operating plan, the Company expects its net loss for 2021 to be in the range of $30.0 to $34.0 million for the fiscal year, a decrease over prior guidance of $32.0 to $36.0 million. Duyuru • Jul 15
scPharmaceuticals Inc. Announces Positive Top-Line Results from FREEDOM-HF Study scPharmaceuticals Inc. announced positive top-line results from its FREEDOM-HF study. FREEDOM-HF was a prospective clinical trial evaluating overall and heart failure-related costs of treating congestion in patients with chronic heart failure. Patients were treated with FUROSCIX®, investigational product, post-discharge from the emergency department compared to a historical comparator group that was treated with intravenous furosemide in the inpatient hospital setting. Based on the results from a planned, prespecified interim analysis conducted to confirm the final sample size, and following input from statisticians, principal investigators, payer advisors and Health Economics and Outcomes Research (HEOR) experts, enrollment was stopped on May 17, 2021, prior to the enrollment target of 34 patients. This decision was made due to the highly statistically significant reduction observed in 30-day heart failure-related costs in patients who received FUROSCIX in the interim analysis. The final analysis included 24 subjects treated with FUROSCIX and 66 matched comparators based on seven variables associated with hospitalization. Comparator patients hospitalized for 72 hours or less were identified, and costs were derived from service-level claims utilizing IBM® MarketScan® Research Databases which utilizes coding to standardize financial data from fully paid and adjudicated claims. The mean difference in heart failure-related costs between the two groups was $17,753 per study subject, with a p-value of p<0.0001 (95% CI: -$23,660, -$11,846), favoring the FUROSCIX group. This difference in costs was driven primarily by hospitalization costs. Per protocol, all subjects (24/24) who were enrolled in the study and received FUROSCIX did not require an initial heart failure hospitalization, and all but one (95.8%) remained out of the hospital for heart failure for the subsequent 30-day period. In the comparator group, 100% of the patients were initially hospitalized and 10.6% had a heart failure-related readmission. As part of the study design, all FUROSCIX patients were required to have at least one heart failure related clinic visit during the study period. In the comparator group, 34.9% of subjects had a heart failure related clinic visit. Since the price for FUROSCIX has not been established, the difference in costs does not include the cost of FUROSCIX. Additional analyses, including 30-day overall healthcare cost, quality of life as well as patient and caregiver satisfaction, are ongoing and complete data will be submitted for publication or presentation at an upcoming scientific meeting. The most common adverse events with FUROSCIX were infusion site pain, bruising and dizziness and no serious adverse events related to FUROSCIX were observed. Duyuru • Jul 03
scPharmaceuticals Inc. Announces Receipt of Written Minutes from Type C Meeting with the FDA Regarding Development of FUROSCIX® scPharmaceuticals Inc. announced that on June 30, 2021 the Company received the minutes from its Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the requirements for resubmission of the FUROSCIX New Drug Application (NDA). Based on guidance the Company received during the meeting and subsequently contained within the meeting minutes, the Company is moving forward with its original plan to conduct the required bench testing for the West Pharmaceutical Services’ (West) SmartDose® Gen II on-body drug delivery system that is used to deliver FUROSCIX to heart failure patients. Importantly, the FDA has not requested modifications to the device. Breakeven Date Change • May 16
Forecast to breakeven in 2024 The 2 analysts covering scPharmaceuticals expect the company to break even for the first time. New consensus forecast suggests the company will make a profit of US$14.2m in 2024. Average annual earnings growth of 55% is required to achieve expected profit on schedule. Duyuru • May 13
Scpharmaceuticals Inc. Announces Earnings Guidance for 2021 scPharmaceuticals Inc. announced Based on its current operating plan, the Company expects the net loss for 2021 to be in the range of $32.0 to $36.0 million for the fiscal year. Duyuru • Mar 25
Scpharmaceuticals Inc. Provides Earnings Forecasts for the Year 2021 scPharmaceuticals Inc. provided earnings forecasts for the year 2021. For the period, the company forecasts net loss to be $32 to $36 million. Duyuru • Feb 18
scPharmaceuticals Inc. Appoints William T. Abraham, M.D., to Its Board of Directors scPharmaceuticals Inc. announced the appointment of William T. Abraham, M.D., to the company’s Board of Directors. Dr. Abraham currently serves as Professor of Internal Medicine (Cardiology), Physiology and Cell Biology and College of Medicine Distinguished Professor at The Ohio State University as well as Chief Medical Officer at V-Wave Ltd., a privately held developer of percutaneous implantable therapeutic devices for chronic heart failure patients. Is New 90 Day High Low • Dec 08
New 90-day low: €4.40 The company is down 36% from its price of €6.85 on 09 September 2020. The German market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is flat over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Duyuru • Dec 06
Scpharmaceuticals Inc. Announces Resignation of Mason W. Freeman as A Member of the Board and All Committees, Effective as of December 15, 2020 scPharmaceuticals Inc. announced that Mason W. Freeman, M.D. informed the Board of Directors of scPharmaceuticals Inc. of his resignation as a member of the Board and all committees of the Board, effective as of December 15, 2020. There are no disagreements between Dr. Freeman and the Company on any matter relating to the Company's operations, policies or practices. Duyuru • Nov 18
Scpharmaceuticals Inc. Announces Financial Guidance for 2020 scPharmaceuticals Inc. announced that based on the current operating plan, the Company expects the net loss for 2020 to be lower than prior guidance and in the range of $34.0 to $37.0 million for the fiscal year. Is New 90 Day High Low • Nov 11
New 90-day high: €7.75 The company is up 16% from its price of €6.70 on 13 August 2020. The German market is flat over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is down 4.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Is New 90 Day High Low • Oct 24
New 90-day high: €7.60 The company is up 21% from its price of €6.30 on 24 July 2020. The German market is down 1.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is down 9.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Duyuru • Oct 10
scPharmaceuticals Inc. Provides Business Update on FUROSCIX scPharmaceuticals Inc. provided a business update on FUROSCIX®, its investigational proprietary formulation of furosemide for subcutaneous administration. The Company has submitted twelve-month drug stability data to the U.S. Food and Drug Administration (FDA). Pursuant to an agreement with the FDA, scPharmaceuticals was permitted to submit its New Drug Application (NDA) with nine months of drug stability data and submit the remining three months during the FDA’s review. All drug stability data has now been submitted. To prepare for the launch of FUROSCIX, if approved, the Company has made key additions to its commercial team, including vice presidents of marketing, sales and market access. In addition, recruitment for the Company’s field sales team is ongoing and remains closely aligned with currently anticipated regulatory timelines. Duyuru • Sep 18
Scpharmaceuticals Files New Drug Application with Fda Seeking Approval of FUROSCIX® for the Treatment of Congestion Due to Fluid Overload in Adult Patients with Worsening New York Heart Association Class II and Class III Heart Failure Who Display Reduced Responsiveness to Oral Diuretics and Who Do Not Require Hospitalization scPharmaceuticals Inc. has filed a 505(b)(2) New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval of FUROSCIX® for the treatment of congestion due to fluid overload in adult patients with worsening New York Heart Association (NYHA) Class II and Class III heart failure who display reduced responsiveness to oral diuretics and who do not require hospitalization. scPharmaceuticals recently announced that its resubmission has been accepted for review and assigned a Prescription Drug User-Fee Act (PDUFA) target action date of December 30, 2020. Duyuru • Jul 02
scPharmaceuticals Inc.(NasdaqGS:SCPH) dropped from Russell Microcap Value Index scPharmaceuticals Inc.(NasdaqGS:SCPH) dropped from Russell Microcap Value Index