Hyperemia

Generated 4Q 2023 net FUROSCIX® revenue of $6.1 million, at the upper end of the range provided in January and representing sequential growth of 61% from $3.8 million in 3Q 2023 Generated full-year net FUROSCIX® revenue of $13.6 million, at the upper end of the range provided in January Ended 2023 with cash, cash equivalents and short-term investments of $76 million Company to host investor conference call and webcast today, Wednesday, March 13, at 4:30pm ET BURLINGTON, Mass., March 13, 2024 (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 fourth quarter and full-year ended December 31, 2023, and provided a business update. Business Update For the fourth quarter ended December 31, 2023, scPharmaceuticals reports: Net FUROSCIX revenue of $6.1 million, up 61% sequentially as compared to $3.8 million in the third quarter of 202313,542 total FUROSCIX doses written, up 56% sequentially as compared to 8,676 in the third quarter of 2023 7,016 FUROSCIX doses filled, up 44% sequentially from 4,861 in the third quarter of 20234,592 written doses payer cleared or pending 5.9 doses per prescription1,696 unique prescribers of FUROSCIX from launch through end of the year, up 52% from 1,119 from launch through the end of the third quarter2,331 FUROSCIX in-services completed from launch through end of the year, up from 1,806 from launch through the end of the third quarterGross-to-net discount of 18% from launch through the end of the year, as compared to 21% from launch through the end of third quarterInventory levels at specialty pharmacy partners remained consistent from September 30, 2023 levels Reported that, as of November 1, FUROSCIX is on formulary as a preferred brand with one of the largest government retiree payer formularies, increasing the number of lives with preferred access to FUROSCIX by an additional 1.1 million lives.Continued to see sales of FUROSCIX to integrated delivery networks (IDNs), including a large direct order in late Q4 to one of the largest closed IDN in the United Sates.On track to initiate a pivotal pharmacokinetic (PK) study in Q2 to support development of an 80mg/1mL auto-injector. If successful, scPharmaceuticals plans to submit a New Drug Application (NDA) to the FDA by the end of 2024.Advanced plans to submit an sNDA to the FDA next month seeking expansion of the FUROSCIX indication to include patients suffering from chronic kidney disease (CKD).Announced that the Company’s sNDA submission to the FDA seeking to expand the FUROSCIX indication to include New York Heart Association Class IV heart failure patients is currently under review by the FDA.Ended the fourth quarter of 2023 with cash, cash equivalents and short-term investments of $76.0 million. “We ended 2023 on a strong note, generating net FUROSCIX sequential revenue growth of 61%, which we believe reflects growing awareness and acceptance of FUROSCIX as a key component of a new heart failure treatment paradigm,” stated John Tucker, President, and Chief Executive Officer of scPharmaceuticals. “Our reported gross-to-net discount of 18% declined from launch through the end of Q4 as compared to 21% from launch through the end of Q3. However, we continue to anticipate that the GTN discount will increase over time as our contracting efforts continue to evolve and mature.” “Also, during the fourth quarter, we continued to advance the life cycle management and long-term growth initiatives for FUROSCIX that we previewed last quarter. These include the potential expansion of the FUROSCIX indication to include NYHA Class IV heart failure patients, which is currently under review by FDA, an additional indication in chronic kidney disease, for which we plan to file with the FDA next month , and the development of an auto-injector that would complement the current on-body infusor, a PK study for which we plan to initiate in the next few weeks. We continue to advance these initiatives while at the same time successfully driving uptake of FUROSCIX, and both our fourth quarter results and leading indicators confirm that FUROSCIX acceptance and utilization among heart failure specialists is accelerating,” Mr. Tucker concluded. Fourth Quarter and Full-Year 2023 Financial Results and Financial Guidance Fourth Quarter 2023 Product revenues were $6.1 million, and cost of product revenues were $1.8 million for the fourth quarter of 2023. Research and development expenses were $3.3 million for the fourth quarter of 2023, compared to $2.3 million for the fourth quarter of 2022. The increase in research and development expenses for the quarter ended December 31, 2023, was primarily due to an increase in device and pharmaceutical development costs and clinical study costs. The increase was partially offset by a decrease in employee related costs. Selling, general and administrative expenses were $16.2 million for the fourth quarter of 2023, compared to $7.2 million for the fourth quarter of 2022. The increase in selling, general and administrative expenses for the quarter ended December 31, 2023, was primarily due to an increase in employee related costs and commercial costs. scPharmaceuticals reported a net loss of $13.8 million for the fourth quarter of 2023, compared to $9.2 million for the fourth quarter of 2022. Full-Year 2023 Product revenues were $13.6 million, and cost of product revenues were $3.8 million for the full-year 2023. Research and development expenses were $11.8 million for the full-year 2023, compared to $15.5 million for the full-year 2022. The decrease in research and development expenses for the full-year 2023 was primarily due to a decrease in clinical study and medical affairs costs, employee related costs, quality and regulatory consulting costs, and patent costs. The decrease was partially offset by an increase in pharmaceutical development costs. Selling, general and administrative expenses were $53.4 million for the full year 2023, compared to $20.6 million for the full-year 2022. The increase in selling, general and administrative expenses for the full-year 2023 was primarily due to an increase in employee related costs and commercial preparation costs, operations, quality and regulatory costs, and legal costs. The increase was partially offset by a decrease in insurance related costs. scPharmaceuticals reported a net loss of $54.8 million for the full-year 2023, compared to $36.8 million for the full-year 2022. scPharmaceuticals ended 2023 with $76 million in cash, cash equivalents and short-term investments, compared to $118.4 million as of December 31, 2022. As of December 31, 2023, scPharmaceuticals’ total shares outstanding was 35,968,510. Conference call and webcast information scPharmaceuticals’ management will host a conference call and webcast to review the Company’s fourth quarter and full-year 2023 results today, Wednesday, March 13, at 4:30 p.m. ET. Participants should dial 1-877-407-9208 (domestic) or 1-201-493-6784 (international) with the conference code 13744172. To access the Call me™ feature, which avoids having to wait for an operator, click here. A link to the live webcast can be found here. Following the live webcast, a replay of the event will be archived on scPharmaceuticals’ website for one year. 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. For more details, please read the full Prescribing Information at FUROSCIX.com/prescribing-information.pdf and Instructions for Use at FUROSCIX.com/instructions-for-use.pdf. 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 Statements This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, but not limited to, statements regarding the potential market impact and benefits of FUROSCIX and the success of the commercialization of FUROSCIX, the trial initiation, anticipated results, clinical design, potential regulatory submissions, approvals and timing thereof of the PK study, the potential expansion of the FUROSCIX indication to include NYHA Class IV heart failure patients and the timing thereof, the potential for continued sales of FUROSCIX to IDNs, the potential expansion of the FUROSCIX indication to include treatment of edema in patients with chronic kidney disease, and participation in upcoming events and presentations. 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, our dependence on the commercial success of FUROSCIX and, if approved, our other product candidates, risks related to the receipt of regulatory approval for our product candidates, risks related to our ability to manufacture, or the ability of third parties to deliver, sufficient product for commercialization of FUROSCIX or any of our product candidates, if approved , risks related to our history of operating losses, and the risk that global economic factors and uncertainties will impact the Company’s operations. For a discussion of these and 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 sections entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, on file with the Securities and Exchange Commission, available at the Securities and Exchange Commission’s website at www.sec.gov, 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 MirandascPharmaceuticals Inc., 781-301-6869kmiranda@scpharma.com Investors:PJ KelleherLifeSci Advisors, 617-430-7579pkelleher@lifesciadvisors.com scPharmaceuticals Inc. Consolidated Statements of Operations (in thousands, except share and per share data) THREE MONTHS ENDED DECEMBER 31, YEAR ENDED DECEMBER 31, 2022 2023 2022 2023 Product revenues, net$- $6,096 $- $13,593 Operating expenses: Cost of product revenues$- $1,773 $- $3,811 Research and development 2,326 3,338 15,533 11,809 Selling, general and administrative 7,176 16,242 20,624 53,369 Total operating expenses 9,502 21,353 36,157 68,989 Loss from operations (9,502) (15,257) (36,157) (55,396)Other (expense) income 1,363 2,412 1,418 3,605 Interest income 850 1,125 1,203 5,104 Interest expense (1,959) (2,092) (3,302) (8,123)Net loss$(9,248) $(13,812) $(36,838) $(54,810)Net loss per share, basic and diluted$(0.30) $(0.35) $(1.30) $(1.42)Weighted—average common shares outstanding, basic and diluted 31,253,909 38,786,956 28,358,502 38,513,747 scPharmaceuticals Inc. Consolidated Balance Sheet Data (in thousands) AS OF DECEMBER 31, 2022 2023 Cash, cash equivalents, restricted cash and investments $118,368 $76,013 Working capital 115,892 79,804 Total assets 124,195 94,479 Term loan 36,794 38,811 Accumulated deficit (226,536) (281,346)Total stockholders’ equity 72,433 37,218

Encinitas, California--(News - March 8, 2024) - Kiora Pharmaceuticals, Inc. (NASDAQ: KPRX), ("Kiora" or the "Company") announced the publication of results from a Phase 1 double-masked study of KIO-101, a potent, non-steroidal anti-inflammatory agent. KIO-101 contains the same active molecule as KIO-104, which belongs to a family of potent anti-inflammatory agents, The study showed that a 12-day treatment of KIO-101 topically at multiple doses was well tolerated in healthy volunteers and patients with inflammation of the eye. There was a significant decrease in conjunctival hyperemia in the treatment group compared to the placebo group. Conjunctival hyperemia, a sign of ocular inflammation, is due to a variety of non-infectious and infectious causes. The paper was published in the journal, Pharmaceutics (2024, 16(3), 367 | ) Kiora's KIO-100 family of compounds contain the same proprietary active molecule but are uniquely formulated for a specific condition and region of the eye being targeted. KIO-101 is the designation for topical delivery and KIO-104 is the designation for intravitreal injection (directly into the eye). Kiora's active molecule belongs to a class of drugs known as DHODH inhibitors, including teriflunomide, an FDA-approved drug that has been prescribed to hundreds of thousands of patients with multiple sclerosis. DHODH inhibitors are believed to reduce the production of T-cells, a type of immune cell that, in certain conditions like autoimmune disease, can cause damaging inflammation. Delivering KIO-101 or KIO-104 locally in the eye aims to reduce T-cell-related inflammation without the associated potential side effects of systemic anti-inflammatory drugs. "These results support the therapeutic potential of our molecule to address inflammation in the eye," explained Eric Daniels, MD, Chief Development Officer, Kiora. "A Phase 2 trial of KIO-104 is expected to start later this year to treat posterior non-infectious uveitis, a rare inflammatory condition of the retina. Because uveitis can lead to vision loss, there's an important need for new treatment options beyond chronic steroid injections or systemic autoimmune disease drugs currently being used today. Beyond uveitis, we see an opportunity to target additional retinal inflammatory diseases that could similarly benefit from a non-steroidal therapeutic option." The published study involved a double-masked, placebo-controlled, randomized, parallel-group design that consisted of two parts. In Part I, 24 healthy volunteers received single or multiple administrations of KIO-101 eye drops in ascending doses (0.05%, 0.15% or 0.30%). Part II involved 21 patients with conjunctival hyperemia who received either 0.15% KIO-101 eye drops or vehicle (2:1) twice daily for 12 consecutive days. The findings include the following: KIO-101 eye drops were well tolerated in all subjects. There were no serious adverse events. All adverse events were transient and considered mild to moderate. In the highest dose cohort (0.30%), epistaxis occurred in two subjects after multiple instillations. In Part II, after 12 days of treatment with 0.15% KIO-101, conjunctival hyperemia decreased by 1.1 ± 0.27 points in the KIO-101 treated group versus 0.6 ± 0.79 points in the placebo group (p = 0.0385). From baseline to day 12, the Ocular Surface Disease Index Questionnaire (OSDI) score decreased by 20.3 points in the treatment group, while in the placebo group decreased by 14.0 points (p=ns). Kiora is planning a Phase 2 clinical trial of KIO-104 to be administered by intravitreal injection directly into the retina for the treatment of posterior non-infectious uveitis. The Company previously reported positive results from a Phase 1 study of KIO-104 for treatment of posterior non-infectious uveitis. Posterior non-infectious uveitis is a rare autoimmune disease characterized by inflammation of the retina, choroid, vitreous, or optic nerve, and can result in severe vision loss. It can result from many underlying causes, which may include the ocular manifestation of certain autoimmune diseases. About Kiora Pharmaceuticals Kiora Pharmaceuticals is a clinical-stage biotechnology company developing and commercializing products for the treatment of orphan retinal diseases. KIO-301 is being developed for the treatment of retinitis pigmentosa, choroideremia, and Stargardt disease. It is a molecular photoswitch that has the potential to restore vision in patients with inherited and/or age-related retinal degeneration. KIO-104 is being developed for the treatment of posterior non-infectious uveitis. It is a next-generation, non-steroidal, immuno-modulatory, and small-molecule inhibitor of dihydroorotate dehydrogenase. In addition to news releases and SEC filings, we expect to post information on our website, , and social media accounts that could be relevant to investors. We encourage investors to follow us on Twitter and LinkedIn as well as to visit our website and/or subscribe to email alerts. Forward-Looking Statements Some of the statements in this press release are "forward-looking" and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These "forward-looking" statements include statements relating to, among other things, the potential of the KIO-100 family to address inflammation in the eye, the expected timing of a Phase 2 trial of KIO-104, and the development and commercialization efforts and other regulatory or marketing approval efforts pertaining to Kiora's development-stage products, including KIO-104, as well as the success thereof, where such approvals or success may not be obtained or achieved on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, the ability to conduct clinical trials on a timely basis, the ability to obtain any required regulatory approvals, whether future trials will yield similar results for participants, market and other conditions, and certain risk factors described under the heading "Risk Factors" contained in Kiora's Annual Report on Form 10-K filed with the SEC on March 23, 2023, or described in Kiora's other public filings. Kiora's results may also be affected by factors of which Kiora is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. Kiora expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions, or circumstances on which any such statement is based, except as required by law. Contact Information: Investors@kiorapharma.com To view the source version of this press release, please visit

GALWAY, Ireland--( BUSINESS WIRE )--WhiteSwell, a company pioneering a new paradigm in the treatment of acute decompensated heart failure (ADHF), announced today positive six-month follow-up data on the initial nine patients treated in its ongoing DELTA-HF trial evaluating the WhiteSwell eLym™ System. The data were presented by William Abraham, M.D., professor of medicine, physiology, and cell biology at The Ohio State University Wexner Medical Center, at the Technology and Heart Failure Therapeutics (THT) conference today in Boston. Nine hospitalized patients with ADHF received eLym therapy in conjunction with diuretic therapy and were followed for six months. Summary of key findings: Reduced tissue congestion: A biomarker of tissue congestion, CA-125, decreased 77% from baseline to a median of 23 u/ml at 90 days. Reduced rehospitalizations: Comparing patients’ clinical course before and after eLym therapy, in the six months prior to eLym therapy there were 13 heart failure related hospitalizations, while in the six months after eLym therapy there were just two heart failure hospitalizations and one heart failure related death, for a 77% reduction. The minimally invasive catheter system was successfully deployed and removed in all patients, with a mean treatment time of 24 hours. At hospital discharge, acute decongestion was demonstrated by a mean weight loss of approximately 6 kg and the elimination of orthopnea and reduction of peripheral edema in all patients. Kidney function was preserved in all patients during treatment and out to 30 days. The treatment was safe with no serious procedure-, device- or therapy-related adverse events in eight out of nine patients. “ These data demonstrate that the eLym System is safe and, in conjunction with loop diuretics, can support consistent improvement of multiple markers of decongestion, all while preserving renal function,” said William Abraham, M.D. “ We were especially encouraged by the dramatic reductions in heart failure related events, which were reduced despite no up-titration of guideline-directed medical therapy. I look forward to additional clinical data building upon these findings.” Patients with acute decompensated heart failure who are discharged with persistent congestion tend to experience poor outcomes, including rehospitalization and death. In the DELTA-HF trial, patients are treated with the minimally invasive, catheter-based eLym System to facilitate fluid removal from the body’s tissues and organs, concurrent with diuretic removal of excess vascular fluid. The eLym System works by targeting the body’s largest lymphatic vessel, the thoracic duct, and creates pressure conditions that support the tissue drainage capabilities of the overwhelmed lymphatic system. “ We have patients with ADHF who are frequently hospitalized with congestion, and they are very challenging to treat,” said George Khabeishvili, M.D., Principal Investigator, Tbilisi Heart and Vascular Clinic in Tbilisi, Georgia. “ The unique treatment approach with the eLym System involves a straightforward procedure. The therapy has helped my patients feel better and, importantly, helped keep them out of the hospital.” About the DELTA-HF Trial The Decongestion of Excess Lymphatic Fluid via the Thoracic Duct in Acute Decompensated Heart Failure (DELTA-HF) trial is a non-randomized early feasibility trial evaluating the safety and performance of the eLym System, a unique approach for the treatment of fluid overload or congestion in patients with ADHF. About the eLym™ System The eLym System is a minimally invasive catheter-based system designed to facilitate the removal of excess fluid from tissues and organs (interstitial fluid) in patients with ADHF by supporting the overwhelmed lymphatic system’s ability to actively drain fluid. The eLym System is deployed in the left internal jugular and innominate veins near where the lymphatic system’s major highway, the thoracic duct, connects. It creates a low-pressure zone to facilitate fluid drainage in conjunction with intravenous diuretics. About WhiteSwell WhiteSwell is a patient-focused company dedicated to improving treatment of acute decompensated heart failure (ADHF), a primary cause of repeat hospitalization and emergency room visits. A privately held company, WhiteSwell is headquartered in Galway, Ireland. For more information visit www.whiteswell.com .