SCPH scPharmaceuticals Inc.

6
+0.05  (+1%)
Previous Close 5.95
Open 5.87
52 Week Low 4.75
52 Week High 9.64
Market Cap $164,132,724
Shares 27,355,454
Float 15,210,483
Enterprise Value $92,906,951
Volume 66,921
Av. Daily Volume 117,866
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Upcoming Catalysts

Drug Stage Catalyst Date
FUROSCIX (furosemide)
Heart failure
NDA Filing
NDA Filing
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Drug Pipeline

Drug Stage Notes
FUROSCIX (FREEDOM-HF)
Heart Failure
Phase 3
Phase 3
Phase 3 data released July 13 2021, study halted early due to highly statistical reduction in costs of $17,753 (p<0.0001) per study subject

Latest News

  1. Data show statistically significant and meaningful reduction in both heart failure-related and overall healthcare costs for patients treated with FUROSCIX® versus a historical comparator group

    Company on track to resubmit FUROSCIX NDA in the fourth quarter 2021

    BURLINGTON, Mass., Sept. 10, 2021 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (NASDAQ:SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today 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…

    Data show statistically significant and meaningful reduction in both heart failure-related and overall healthcare costs for patients treated with FUROSCIX® versus a historical comparator group

    Company on track to resubmit FUROSCIX NDA in the fourth quarter 2021

    BURLINGTON, Mass., Sept. 10, 2021 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (NASDAQ:SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today 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.

    "We are pleased to present these very compelling results from the FREEDOM-HF study at this year's HFSA meeting," stated John Tucker, chief executive officer of scPharmaceuticals. "In this study, there was a highly statistically significant and meaningful cost savings associated with treating HF patients with FUROSCIX. These data provide a strong pharmacoeconomic case for the broad adoption of FUROSCIX as a viable HF treatment pre-admission or post-discharge, if approved by the Food and Drug Administration (FDA).

    Following our Type-C meeting with the FDA in June, we are 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 our New Drug Application (NDA) in the fourth quarter of this year."

    FREEDOM-HF was a prospective clinical trial evaluating 30-day heart failure-related and overall costs of treating congestion in patients with chronic HF. Patients were treated with FUROSCIX, the Company's investigational product, post-discharge from the emergency department compared to a historical comparator group that was managed in the hospital setting.

    The HFSA Annual Scientific Meeting 2021 is being held virtually and in a hybrid format in Denver, Colorado from September 10-14, 2021. A copy of the poster can be accessed under the News and Events section of the Company's website.

    Late-breaking HFSA Poster Presentation Details and Data:
    Title: Significantly Reduced Healthcare Costs with Home FUROSCIX Versus in Hospital IV Diuresis: Results from the FREEDOM-HF Study
    Presenter: Daniel Bensimhon, MD
    Session: Session PV.01 - Poster Viewing Session I
    Date: Friday, September 10, 2021
    Time: 6:36-6:46pm MT (8:36-8:46pm ET)

    90 subjects were enrolled in the study, 24 in the FUROSCIX group and 66 in the comparator group.

    Comparators were hospitalized for ≤72 hours and were selected from a claims database matched to seven variables associated with HF-related hospitalization and severity. Baseline patient characteristics (key matching variables) were similar between the study groups, as were the incidence of co-morbidities and HF medication use.

    FUROSCIX utilization led to a statistically significant reduction in 30-day HF-related and overall healthcare costs.

    • Mean 30-day HF-related costs were $17,753 lower in the FUROSCIX treated group ($2,920) versus the comparator group ($20,673, p-value<0.0001).
    • Similarly, mean 30-day total healthcare costs were $30,568 lower in the FUROSCIX treated group ($7,090) versus the comparator group ($37,658, p-value<0.0001).
    • There were no serious adverse events (SAEs) attributed to study drug, and there were no deaths or study withdrawals due to an SAE.
    • Injection site bruising (29%), discomfort (29%) and dizziness (13%) were the most common side effects of FUROSCIX; all were mild in severity and none led to study withdrawal.
    • This analysis excludes the cost of FUROSCIX, as the price has yet to be established.

    Authors' Conclusion:

    HF patients with mild to moderate volume overload (despite oral diuretic use) can be safely discharged from the emergency department with subcutaneous FUROSCIX, enabling outpatient decongestion. FUROSCIX use was associated with statistically significant reduced overall and HF-related healthcare costs through a reduction in HF-related hospitalizations.

    About FUROSCIX® (furosemide injection) for subcutaneous injection

    FUROSCIX is an investigational, proprietary furosemide solution formulated to a neutral pH, designed to allow for subcutaneous infusion via a wearable, pre-programmed on-body infusor, for outpatient self-administration. FUROSCIX is currently under development 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 who display reduced responsiveness to oral diuretics and who do not require hospitalization. If approved, FUROSCIX has the potential to provide an outpatient alternative for the treatment of worsening heart failure due to congestion.

    About scPharmaceuticals

    scPharmaceuticals is a pharmaceutical company focused on developing and commercializing products that are designed to reduce healthcare costs and improve health outcomes. The Company develops, internally and through strategic partnerships, innovative products and solutions that aim to expand and advance the outpatient care of select acute conditions. The Company's lead programs focus on the subcutaneous, self-administration of IV-strength treatments in heart failure and infectious disease. scPharmaceuticals is headquartered in Burlington, MA. For more information, please visit www.scPharmaceuticals.com.

    Forward-Looking Statement

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding the significance of the results of the FREEDOM-HF clinical trial; the interpretation and analyses of the results from the FREEDOM-HF clinical trial; the planned resubmission of the FUROSCIX NDA, including potential timing of the resubmission and expected timing of the FDA's review; the potential timing of, and the Company's expected progress towards, the advancement of the Company's device verification, research and validation studies; and the Company's planned efforts to prepare for commercialization of FUROSCIX and the success of such commercialization, if approved. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive reviews of the data, and as more patient data become available, the risk that results of a clinical study are subject to interpretation and additional analyses may be needed and/or may contradict such results, the risk of the ability of the FUROSCIX On-Body Infusor to appropriately deliver therapy, the receipt of regulatory approval for the FUROSCIX On-Body Infusor or any of our other product candidates or, if approved, the successful commercialization of such products, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our product candidates, and the risk that the current COVID-19 pandemic will impact the Company's device validation, drug stability testing, the timing of the Company's resubmission of the FUROSCIX NDA and other operations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2020 on file with the Securities and Exchange Commission, available at the Securities and Exchange Commission's website at www.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.

    Katherine Taudvin

    scPharmaceuticals Inc., 781-301-6706

    ktaudvin@scpharma.com

    Investors:

    Hans Vitzthum

    LifeSci Advisors, 617-430-7578

    hans@lifesciadvisors.com

    Media:

    Kate Coyle

    ICR Inc., 203-682-8210

    Kate.coyle@icrinc.com

     



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  2. BURLINGTON, Mass., Sept. 01, 2021 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (NASDAQ:SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that John Tucker, president & chief executive officer, is scheduled to present at the H.C. Wainwright 23rd Annual Global Investment Conference, being held virtually September 13-15, 2021.

    Event:

    H.C. Wainwright 23rd Annual Global Investment Conference
    Monday, September 13 – Wednesday, September 15
    A webcast of Mr. Tucker's presentation will be available on-demand as of 7am EDT, Monday, September 13. It can be accessed under "News…

    BURLINGTON, Mass., Sept. 01, 2021 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (NASDAQ:SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced that John Tucker, president & chief executive officer, is scheduled to present at the H.C. Wainwright 23rd Annual Global Investment Conference, being held virtually September 13-15, 2021.

    Event:

    H.C. Wainwright 23rd Annual Global Investment Conference

    Monday, September 13 – Wednesday, September 15

    A webcast of Mr. Tucker's presentation will be available on-demand as of 7am EDT, Monday, September 13. It can be accessed under "News & Events" in the Investor Relations section of the Company's website, www.scpharmaceuticals.com.

    About scPharmaceuticals

    scPharmaceuticals is a pharmaceutical company focused on developing and commercializing products that are designed to reduce healthcare costs and improve health outcomes. The Company develops, internally and through strategic partnerships, innovative products and solutions that aim to expand and advance the outpatient care of select acute conditions. The Company's lead programs focus on the subcutaneous, self-administration of IV-strength treatments in heart failure and infectious disease. scPharmaceuticals is headquartered in Burlington, MA. For more information, please visit www.scPharmaceuticals.com.

    Katherine Taudvin

    scPharmaceuticals Inc., 781-301-6706

    ktaudvin@scpharma.com

    Investors:

    Hans Vitzthum

    LifeSci Advisors, 617-430-7578

    hans@lifesciadvisors.com



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  3. Received minutes from Type C meeting with the FDA confirming alignment on path toward resubmission of FUROSCIX® NDA; no additional clinical data or device modifications required at this time; on track for resubmission in Q4

    Announced positive top-line results from the FREEDOM-HF study demonstrating that average 30-day heart failure-related costs were reduced by $17,753 per study subject in the FUROSCIX arm compared to historically matched comparators

    Ended Q2 with cash, cash equivalents, restricted cash and investments of $90.2 million, sufficient to fund operations, as currently planned, into 2023; lowered 2021 net loss guidance to $30.0 to $34.0 million

    BURLINGTON, Mass., Aug. 11, 2021 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (NASDAQ…

    Received minutes from Type C meeting with the FDA confirming alignment on path toward resubmission of FUROSCIX® NDA; no additional clinical data or device modifications required at this time; on track for resubmission in Q4

    Announced positive top-line results from the FREEDOM-HF study demonstrating that average 30-day heart failure-related costs were reduced by $17,753 per study subject in the FUROSCIX arm compared to historically matched comparators

    Ended Q2 with cash, cash equivalents, restricted cash and investments of $90.2 million, sufficient to fund operations, as currently planned, into 2023; lowered 2021 net loss guidance to $30.0 to $34.0 million

    BURLINGTON, Mass., Aug. 11, 2021 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (NASDAQ:SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced financial results for the second quarter ended June 30, 2021 and provided a business update. 

    Business Update

    • Completed Type C meeting with the U.S. Food and Drug Administration (FDA) and received minutes that confirm alignment on the path toward resubmission of the FUROSCIX New Drug Application (NDA).
      • No additional clinical data or device modifications required at this time.
      • Subject to West Pharmaceutical Services' completion of its portion of the regulatory filing, the Company is targeting the resubmission of its NDA in the fourth quarter of this year and anticipates a six-month review by the FDA.
    • Announced positive top-line results from the FREEDOM-HF study demonstrating that average 30-day heart failure-related costs were reduced by $17,753 per study subject in the FUROSCIX arm compared to historically matched comparators, with a very high level of statistical significance (p<0.0001).
      • Due to the highly statistically significant reduction in 30-day heart failure-related costs observed during the prespecified interim analysis, the decision was made to close enrollment earlier than anticipated.
      • The difference in costs was driven primarily by hospitalization costs. Per protocol, all subjects (24/24) who 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.
    • FREEDOM-HF data has been accepted as a Late Breaking Clinical Trial for presentation at the upcoming Heart Failure Society of America (HFSA) Annual Scientific Meeting being held September 10 through September 13, 2021 both in Denver, Colorado and virtually.
    • Continued to enroll the AT HOME-HF PILOT study evaluating the effectiveness and safety of FUROSCIX versus continued medical therapy in patients with chronic heart failure and fluid overload requiring augmentation in diuretic therapy outside of the hospital.
    • Ended the second quarter with cash, cash equivalents, restricted cash and investments of $90.2 million.

    "During the second quarter and subsequent period, we made significant progress, gaining alignment with the FDA on the path toward our FUROSCIX NDA resubmission, which we are targeting for Q4," stated John Tucker, chief executive officer of scPharmaceuticals. "Importantly, the FDA is not requiring additional clinical data or modifications to the on-body infusor at this time, and we are working tirelessly to complete the additional bench testing that has been requested. If our NDA is accepted, we anticipate a six-month review, suggesting that FUROSCIX, if approved, could be available to heart failure patients in the second half of next year.

    "To further support a potential commercial launch, we were extremely pleased with the top-line results from our FREEDOM-HF study which demonstrated that patients treated with FUROSCIX cost healthcare payers nearly $18,000 less over a 30-day span as compared to historically matched comparators. Given the prevalence of worsening heart failure, and the potential addressable market of 2.1 million heart failure events in the United States, this pharmacoeconomic benefit is significant and should aid in adoption of FUROSCIX, if approved.

    "We ended the quarter in a strong cash position, which we believe is sufficient to fund operations through a potential launch and into 2023. We look forward to introducing this novel therapy, if approved, to the many heart failure patients who can benefit," Mr. Tucker concluded.

    Second Quarter 2021 Financial Results and Financial Guidance

    scPharmaceuticals ended the second quarter with $90.2 million in cash, cash equivalents, restricted cash and investments, compared to $105.3 million as of December 31, 2020, The Company believes its cash, cash equivalents, restricted cash and investments are sufficient to fund operations into 2023.

    scPharmaceuticals reported a net loss of $7.1 million for the second quarter of 2021, compared to $8.3 million for the comparable period in 2020.

    Research and development expenses were $3.8 million for the second quarter of 2021, compared to $5.1 million for the comparable period in 2020. The decrease in research and development expenses for the quarter ended June 30, 2021 was primarily due to a decrease in device development costs, offset by an increase in costs related to pharmaceutical development and medical affairs, as well as an increase in employee-related costs.

    General and administrative expenses were $2.6 million for the second quarter of 2021, compared to $2.5 million for the comparable period in 2020. The increase in general and administrative costs for the quarter ended June 30, 2021 was primarily attributable to an increase in consulting and director and officer's insurance costs, offset by a decrease in legal costs.

    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.

    About FUROSCIX® (furosemide injection) for subcutaneous injection

    FUROSCIX is an investigational, proprietary furosemide solution formulated to a neutral pH, designed to allow for subcutaneous infusion via a wearable, pre-programmed on-body infusor, for outpatient self-administration. FUROSCIX is currently under development 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 who display reduced responsiveness to oral diuretics and who do not require hospitalization. If approved, FUROSCIX has the potential to provide an outpatient alternative for the treatment of worsening heart failure due to congestion.

    About scPharmaceuticals

    scPharmaceuticals is a pharmaceutical company focused on developing and commercializing products that are designed to reduce healthcare costs and improve health outcomes. The Company develops, internally and through strategic partnerships, innovative products and solutions that aim to expand and advance the outpatient care of select acute conditions. The Company's lead programs focus on the subcutaneous, self-administration of IV-strength treatments in heart failure and infectious disease. scPharmaceuticals is headquartered in Burlington, MA. For more information, please visit www.scPharmaceuticals.com.

    Forward-Looking Statement

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding the significance of the results of the FREEDOM-HF clinical trial; the interpretation and analyses of the results from the FREEDOM-HF clinical trial; the planned resubmission of the FUROSCIX NDA, including potential timing of the resubmission and expected timing of the FDA's review; the potential timing of, and the Company's expected progress towards, the advancement of the Company's device verification, research and validation studies; the Company's planned efforts to prepare for commercialization of FUROSCIX, and the success of such commercialization, if approved; and the potential benefits, expected costs and future plans and expectations for FUROSCIX, if approved, and the Company's projected financial guidance, including projected annual loss. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive reviews of the data, and as more patient data become available, the risk that results of a clinical study are subject to interpretation and additional analyses may be needed and/or may contradict such results, the risk of the ability of the FUROSCIX On-Body Infusor to appropriately deliver therapy, the receipt of regulatory approval for the FUROSCIX On-Body Infusor or any of our other product candidates or, if approved, the successful commercialization of such products, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our product candidates, and the risk that the current COVID-19 pandemic will impact the Company's device validation, drug stability testing, the timing of the Company's resubmission of the FUROSCIX NDA and other operations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2020 on file with the Securities and Exchange Commission, available at the Securities and Exchange Commission's website at www.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.

    Katherine Taudvin

    scPharmaceuticals Inc., 781-301-6706

    ktaudvin@scpharma.com

    Investors:

    Hans Vitzthum

    LifeSci Advisors, 617-430-7578

    hans@lifesciadvisors.com

    scPharmaceuticals Inc.           
    Unaudited Consolidated Statements of Operations           
    (in thousands, except share and per share data)           
                
     THREE MONTHS ENDED JUNE 30,

      SIX MONTHS ENDED JUNE 30,

     
     2020  2021  2020  2021 
    Operating expenses:           
    Research and development$5,139  $3,807  $9,285  $7,816 
    General and administrative2,537  2,649  5,040  5,381 
    Total operating expenses7,676  6,456  14,325  13,197 
    Loss from operations(7,676) (6,456) (14,325) (13,197)
    Other (expense) income(1) 33  (32) 288 
    Interest income21  12  245  32 
    Interest expense(639) (651) (1,275) (1,287)
    Net loss$(8,295) $(7,062) $(15,387) $(14,164)
    Net loss per share, basic and diluted$(0.36) $(0.26) $(0.71) $(0.52)
    Weighted—average common shares outstanding, basic and diluted23,355,418  27,355,454  21,786,946  27,346,141 



    scPharmaceuticals Inc.      
    Unaudited Consolidated Balance Sheet Data      
    (in thousands) DECEMBER 31,  JUNE 30, 
      2020  2021 
    Cash, cash equivalents, restricted cash and investments $105,277  $90,203 
    Working capital 98,505  80,604 
    Total assets 109,048  93,615 
    Term loan 19,266  19,449 
    Accumulated deficit (161,664) (175,828)
    Total stockholders' equity 82,170  69,043 


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  4. Study halted early due to highly statistically significant reduction in 30-day heart failure-related costs observed during the prespecified interim analysis

    Company to host conference call and live webcast tomorrow, July 14, at 8:30am ET

    BURLINGTON, Mass., July 13, 2021 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (NASDAQ:SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today announced positive top-line results from its FREEDOM-HF study…

    Reduced average 30-day heart failure related costs by $17,753 (p<0.0001) per study subject in FUROSCIX® arm compared to historically matched comparators

    Study halted early due to highly statistically significant reduction in 30-day heart failure-related costs observed during the prespecified interim analysis

    Company to host conference call and live webcast tomorrow, July 14, at 8:30am ET

    BURLINGTON, Mass., July 13, 2021 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (NASDAQ:SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today 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®, our 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.

    Results Summary:

    • 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.

    "These positive results from our pharmacoeconomic study support our hypothesis that treating heart failure patients with FUROSCIX has the potential to dramatically reduce the significant costs associated with admission or readmission to the hospital," stated John Tucker, chief executive officer of scPharmaceuticals. "As we continue to work toward the resubmission of our new drug application (NDA) later this year, this study provides powerful evidence to payers on the potential economic benefit of FUROSCIX, if approved."

    "We currently lack a tool designed to manage worsening congestion in the outpatient setting in patients with chronic heart failure when oral diuretics are inadequate. This results in heart failure being one of the most common causes of hospital admissions in patients over 65 years of age," stated Dan Bensimhon, MD, Medical Director Advanced Heart Failure & Mechanical Circulatory Support Program, Cone Health. "I believe FUROSCIX, if approved, could represent an important new tool to manage heart failure in the outpatient setting."

    "It has been estimated that up to 90% of patients presenting to the emergency department with symptoms of worsening heart failure are admitted to the hospital, and 50% of these admissions may be potentially avoided," stated James Kenney, RPh, MBA, president of JTKENNEY, LLC, a managed care pharmacy consultancy. "The direct medical costs of heart failure are projected to surpass $53 billion by 2030, with 80% of these expenditures being related to hospitalization. If approved, FUROSCIX has the potential to significantly reduce such costs by shifting management of appropriate patients with congestion from the inpatient to the outpatient setting."

    Conference Call and Webcast

    scPharmaceuticals' management, Dr. Bensimhon and Mr. Kenney will host a conference call and live webcast tomorrow, July 14, at 8:30 am ET.

    Investor Dial-in: 877-407-9208

    Int'l Investor Dial-in: 201-493-6784

    Conference ID: 13721167

    Webcast: http://public.viavid.com/index.php?id=145533

    About FREEDOM-HF

    FREEDOM-HF (FUROSCIX Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure) was a multicenter, prospective adaptive clinical trial to evaluate differences in heart failure and overall costs between subjects receiving FUROSCIX outside the hospital and patients receiving intravenous furosemide in the hospital setting for 30-days after being discharged from the emergency department. Differences in costs were calculated from a comparator group who were hospitalized for 72 hours or less where subjects were matched based on 7 variables associated with heart failure hospitalization and severity derived from IBM® MarketScan® Research Databases. The study was designed to enroll up to 75 subjects in the FUROSCIX cohort to detect a statistically significant difference in 30-day overall and heart failure related costs.

    *About FUROSCIX® (furosemide injection) for subcutaneous injection

    FUROSCIX is an investigational, proprietary furosemide solution formulated to a neutral pH, designed to allow for subcutaneous infusion via a wearable, pre-programmed on-body drug delivery system, for outpatient self-administration. FUROSCIX is currently under development 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 who display reduced responsiveness to oral diuretics and who do not require hospitalization. If approved, FUROSCIX has the potential to provide an outpatient alternative for the treatment of worsening heart failure due to congestion.

    About scPharmaceuticals

    scPharmaceuticals is a pharmaceutical company focused on developing and commercializing products that are designed to reduce healthcare costs and improve health outcomes. The Company develops, internally and through strategic partnerships, innovative products and solutions that aim to expand and advance the outpatient care of select acute conditions. The Company's lead programs focus on the subcutaneous, self-administration of IV-strength treatments in heart failure and infectious disease. scPharmaceuticals is headquartered in Burlington, MA. For more information, please visit www.scPharmaceuticals.com.

    Forward-Looking Statement

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding the significance of the results of the FREEDOM-HF clinical trial; the interpretation and analyses of the results from the FREEDOM-HF clinical trial; the planned resubmission of the FUROSCIX NDA, including potential timing of the resubmission and expected timing of the FDA's review; the potential timing of, and the Company's expected progress towards, the advancement of the Company's device verification, research and validation studies; and the Company's planned efforts to prepare for commercialization of FUROSCIX. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive reviews of the data, and as more patient data become available, the risk that results of a clinical study are subject to interpretation and additional analyses may be needed and/or may contradict such results, the risk of the ability of the FUROSCIX On-Body Infusor to appropriately deliver therapy, the receipt of regulatory approval for the FUROSCIX On-Body Infusor or any of our other product candidates or, if approved, the successful commercialization of such products, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our product candidates, and the risk that the current COVID-19 pandemic will impact the Company's device validation, drug stability testing, the timing of the Company's resubmission of the FUROSCIX NDA and other operations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2020 on file with the Securities and Exchange Commission, available at the Securities and Exchange Commission's website at www.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.

    Katherine Taudvin

    scPharmaceuticals Inc., 781-301-6706

    ktaudvin@scpharma.com

    Investors:

    Hans Vitzthum

    LifeSci Advisors, 617-430-7578

    hans@lifesciadvisors.com

    Media:

    Kate Coyle

    ICR Inc., 203-682-8210

    kate.coyle@icrinc.com



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  5. FDA and Company in alignment on the path forward

    No additional clinical data or device modifications required at this time

    FUROSCIX NDA resubmission targeted for Q4 2021

    BURLINGTON, Mass., July 01, 2021 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (NASDAQ:SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today 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…

    FDA and Company in alignment on the path forward

    No additional clinical data or device modifications required at this time

    FUROSCIX NDA resubmission targeted for Q4 2021

    BURLINGTON, Mass., July 01, 2021 (GLOBE NEWSWIRE) -- scPharmaceuticals Inc. (NASDAQ:SCPH), a pharmaceutical company focused on developing and commercializing products that have the potential to optimize the delivery of infused therapies, advance patient care, and reduce healthcare costs, today 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.

    "We are pleased with the outcome of our Type C meeting, and subsequent receipt of the meeting minutes, as this represents an important step forward as we continue to advance FUROSCIX toward potential commercialization," stated John Tucker, chief executive officer of scPharmaceuticals. "In June, West resumed making the commercial devices that will be used for the required bench testing, and subject to the completion of the Device Master File (DMF) by West, we are targeting the resubmission of our NDA in the fourth quarter of this year and anticipate a six-month review by the FDA."

    "At the same time, we recently completed enrollment in our FREEDOM-HF study and anticipate topline data in July. The results, if positive, can potentially demonstrate significant cost savings from treating congestion in patients with heart failure with FUROSCIX outside of the hospital setting. We are looking forward to better understanding the potential pharmacoeconomic impact of FUROSCIX within this patient population, and the promise of reducing the burden of heart failure."

    scPharmaceuticals ended the first quarter of 2021 with cash, cash equivalents, restricted cash and investments of $96.5 million. The Company believes its cash, cash equivalents, restricted cash and investments are sufficient to fund operations into 2023, unchanged from prior guidance.

    About FUROSCIX® (furosemide injection) for subcutaneous injection

    FUROSCIX is an investigational, proprietary furosemide solution formulated to a neutral pH to allow for subcutaneous infusion via a wearable, pre-programmed on-body drug delivery system, for outpatient self-administration. FUROSCIX is currently under development for the treatment of congestion due to fluid overload in adult patients with 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. FUROSCIX has the potential to provide an outpatient alternative for the treatment of worsening heart failure due to congestion.

    About scPharmaceuticals

    scPharmaceuticals is a pharmaceutical company focused on developing and commercializing products that are designed to reduce healthcare costs and improve health outcomes. The Company develops, internally and through strategic partnerships, innovative products and solutions that aim to expand and advance the outpatient care of select acute conditions. The Company's lead programs focus on the subcutaneous, self-administration of IV-strength treatments in heart failure and infectious disease. scPharmaceuticals is headquartered in Burlington, MA. For more information, please visit www.scPharmaceuticals.com.

    Forward-Looking Statement

    This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding the planned resubmission of the FUROSCIX NDA, including potential timing of the resubmission and expected timing of the FDA's review, the potential timing of the completion of the DMF by West; the potential timing of, and the Company's expected progress towards, the advancement of the Company's device verification, research and validation studies, including the expected timing and results of the FREEDOM-HF clinical trial, the Company's planned efforts to prepare for commercialization of FUROSCIX; and the Company's 2021 financial guidance. Any forward-looking statements in this press release are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk of the ability of the FUROSCIX On-Body Infusor to appropriately deliver therapy, the receipt of regulatory approval for the FUROSCIX On-Body Infusor or any of our other product candidates or, if approved, the successful commercialization of such products, the risk of cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies will not be repeated or observed in ongoing or future studies involving our product candidates, and the risk that the current COVID-19 pandemic will impact the Company's device validation, drug stability testing, the timing of the Company's resubmission of the FUROSCIX NDA and other operations. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled "Risk Factors" in its Annual Report on Form 10-K for the year ended December 31, 2020 on file with the Securities and Exchange Commission, available at the Securities and Exchange Commission's website at www.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in the Company's subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.

    Katherine Taudvin

    scPharmaceuticals Inc., 781-301-6706

    ktaudvin@scpharma.com

    Investors:

    Hans Vitzthum

    LifeSci Advisors, 617-430-7578

    hans@lifesciadvisors.com



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