GlobeNewswire Inc | Nov 16, 2020 07:00AM EST

November 16, 2020

Commercialization preparedness activities continuing ahead of December 30 PDUFA date for FUROSCIX (furosemide injection) for subcutaneous administration

Enrolled first patient in FREEDOM-HF Phase 3 clinical trial

Projected annual net loss for 2020 narrows to $34-37M

BURLINGTON, Mass., Nov. 16, 2020 (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 third quarter ended September 30, 2020 and provided a business update.

Business Update

-- Continued FUROSCIX commercialization preparedness activities in advance of the companys December 30, 2020 Prescription Drug User-Fee Act (PDUFA) target action date. -- Submitted 12-month drug stability data to the U.S. Food and Drug Administration (FDA). Pursuant to an agreement with the FDA, the company was permitted to submit its New Drug Application (NDA) with nine months of drug stability data and submit the remaining three months of drug stability data during the FDAs review of the FUROSCIX NDA. All drug stability data has now been submitted. -- Participated in three virtual poster presentations at the Heart Failure Society of America Virtual Annual Scientific Meeting 2020. -- Hosted a successful Key Opinion Leader webinar. The webinar featured presentations by Dan Bensimhon, M.D. of Cone Health Medical Group and Nihar Desai, M.D., MPH from the Yale School of Medicine who discussed FUROSCIX, the current treatment landscape and the unmet medical need that exists in treating patients with worsening heart failure due to congestion. -- Enrolled the first patient in FREEDOM-HF (Furoscix Real-World Evaluation for Decreasing Hospital Admissions in Heart Failure), a prospective Phase 3 clinical trial evaluating overall and heart failure-related costs for subjects treated with FUROSCIX for 30 days post-discharge from the emergency department compared to patients who remain in the hospital for 24 to 72 hours following hospitalization. Data is expected in the second quarter of 2021 to support the planned commercial launch of FUROSCIX, if approved. -- Ended the third quarter with cash, cash equivalents, restricted cash and investments of $114.5 million.

We are rapidly approaching our December 30 PDUFA date for FUROSCIX which, if approved, will be a transformational event for our company, said John Tucker, president and chief executive officer. We are actively engaged with the FDA in their ongoing review of our NDA. Pending approval, we look forward to executing a successful commercial launch to provide this important therapy to the millions of heart failure patients that suffer every day.

In parallel with our commercial preparedness activities, we were pleased to have enrolled the first patient in our FREEDOM-HF study. The results of FREEDOM-HF, if positive, will demonstrate the significant economic benefits of treating patients who present to the emergency department with worsening heart failure due to congestion with FUROSCIX outside the hospital setting, Mr. Tucker concluded.

Third Quarter 2020 Financial Results and Financial Guidance

scPharmaceuticals reported a net loss of $9.0 million for the third quarter of 2020, compared to $6.2 million for the comparable period in 2019.

Research and development expenses were $5.1 million for the third quarter of 2020, compared to $4.3 million for the comparable period in 2019. The increase in research and development expenses for the quarter ended September 30, 2020 was primarily due to clinical study activity and employee-related costs, offset by a decrease in device and pharmaceutical development activities.

General and administrative expenses were $3.3 million for the third quarter of 2020, compared to $2.0 million for the comparable period in 2019. The increase was primarily attributable to employee-related and professional service costs, including costs related to commercial preparations.

scPharmaceuticals ended the third quarter with $114.5 million in cash, cash equivalents, restricted cash, and investments, compared to $72.8 million as of December 31, 2019.

Based on its 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.

About FUROSCIX (furosemide injection) for subcutaneous injectionFUROSCIX is a 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 worseningNew York Heart Association(NYHA) Class II and Class III heart failure who display reduced responsiveness to oral diuretics and who do not require hospitalization. The FDA has assigned FUROSCIX a PDUFA date ofDecember 30, 2020. FUROSCIX has the potential to provide an outpatient alternative for the treatment of worsening heart failure due to congestion.

About scPharmaceuticalsscPharmaceuticals 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 Companys 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 StatementThis 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 expected timing of the FDAs review of the FUROSCIX NDA, the potential timing of, and the Companys expected progress towards, the advancement of the Companys device verification, research and validation studies, including the expected timing and results of the FREEDOM-HF clinical trial, the Companys planned efforts to prepare for commercialization of FUROSCIX and the success of such commercialization, and the potential benefits, expected costs and future plans and expectations for FUROSCIX, if approved, and the Companys 2020 financial guidance, including projected annual loss. Any forward-looking statements in this press release are based on managements 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 Companys device validation, drug stability testing, the timing of the FDAs review of the Companys 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 endedDecember 31, 2019on file with theSecurities and Exchange Commission, available at the Securities and Exchange Commissions website atwww.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in the Companys subsequent filings with theSecurities 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 TaudvinscPharmaceuticals Inc., 781-301-6706ktaudvin@scpharma.com

Investors:Hans VitzthumLifeSci Advisors, 617-430-7578hans@lifesciadvisors.com

Media:Kate CoyleICR Inc., 203-682-8210kate.coyle@icrinc.com

scPharmaceuticals Inc.UnauditedConsolidated Statements ofOperations(in thousands,except share and per share data) THREE MONTHS ENDED SEPTEMBER NINE MONTHS ENDED SEPTEMBER 30, 30, 2019 2020 2019 2020 Operating expenses:Research and $ 4,293 $ 5,119 $ 16,314 $ 14,404 developmentGeneral and 1,996 3,319 6,158 8,359 administrativeTotal operating 6,289 8,438 22,472 22,763 expensesLoss from (6,289 ) (8,438 ) (22,472 ) (22,763 )operationsOther income 83 19 61 (13 )(expense)Interest income 397 36 1,350 281 Interest expense (398 ) (655 ) (1,121 ) (1,930 )Net loss $ (6,207 ) $ (9,038 ) $ (22,182 ) $ (24,425 )Net loss pershare, basic and $ (0.33 ) $ (0.33 ) $ (1.19 ) $ (1.03 )dilutedWeighted?averagecommon shares 18,584,327 27,319,465 18,580,192 23,644,580 outstanding,basic and diluted

scPharmaceuticals Inc. Unaudited Consolidated Balance Sheet Data (in thousands) DECEMBER 31, SEPTEMBER 30, 2019 2020 Cash, cash equivalents, restricted cash and $ 72,806 $ 114,521 investmentsWorking capital 70,410 108,491 Total assets 77,283 116,960 Term loan 18,915 19,170 Accumulated deficit (129,455 ) (153,880 )Total stockholders? equity 51,365 89,815