Effect of icosapent ethyl on coronary Fat Attenuation Index score in high-risk, statin treated patients with established cardiovascular disease and elevated plasma triglycerides

Start Date26 Mar 2025

Sponsor / Collaborator

Imperial College London

NCT06710080

/ Not yet recruitingPhase 3IIT

Targeting Vascular INflammation in Patients with Community-Acquired Pneumonia (TIN_CAP): a Multi-centre, Prospective, Randomized Control Trial

The goal of this clinical trial is to learn if icosapent ethyl (Vascepa) works to lessen the amount of inflammation in adults diagnosed with Community-Acquired Pneumonia (CAP). The main question it aims to answer is:
What is the effect of taking Vascepa on inflammation in the arteries in patients with CAP? Researchers will compare the drug Vascepa to a placebo (a look-alike submstance that contains no drug) to see if Vascepa works to reduce inflammation in patients with CAP.
Participants wil:
* take Vacscepa or a placebo twice a day for 6 months
* Visit the clinic 3 times (baseline, 30 days, and 6 months) for checkups and tests

Start Date15 Dec 2024

Sponsor / Collaborator

Ottawa Heart Institute Research Corp.

ISRCTN64669648

/ RecruitingNot ApplicableIIT

Does Vazkepa mitigate the negative effects of metabolic memory in monocyte-derived macrophages isolated from patients with cardiovascular disease +/- type 2 diabetes?

Start Date26 Apr 2024

Sponsor / Collaborator

The University of Lincoln

100 Clinical Results associated with Icosapent Ethyl

100 Translational Medicine associated with Icosapent Ethyl

100 Patents (Medical) associated with Icosapent Ethyl

1,040

Literatures (Medical) associated with Icosapent Ethyl

01 Dec 2025·INTERNATIONAL JOURNAL OF CARDIOLOGY

Eligibility for icosapent ethyl 1–3 months after acute coronary syndrome and the risk for myocardial re-infarction: Data from the CALLINICUS-Hellas Registry

Article

Author: Makridakis, Nikolaos ; Leventis, Ioannis ; Vlachopoulos, Charalambos ; Bouratzis, Vasileios ; Nastatos, Panagiotis ; Tsamoulis, Donatos ; Ntalaoutis, Andreas ; Xanthopoulou, Sofia ; Kyriazis, Michalis ; Stamou, Ilektra ; Kakouri, Niki ; Daios, Stylianos ; Rallidis, Loukianos S ; Argyriou, Nikos ; Papathanasiou, Konstantinos A ; Boulmpou, Aristi ; Afentoulis, Vasilis ; Gaitanaki, Tsampika ; Malkots, Belkis ; Styliaras, Athanasios ; Kalogeras, Petros ; Roussos, Christos

BACKGROUND:

Icosapent ethyl (IPE) has been shown to reduce adverse cardiovascular (CV) outcomes in high or very high-risk patients on statins with triglyceride (TG) levels between 135 and 499 mg/dL METHODS: The CALLINICUS-Hellas registry is an ongoing, prospective, multicenter study evaluating lipid profiles, adherence to lipid-lowering therapies, and prognosis in acute coronary syndrome (ACS) patients. This analysis included patients with lipids assessed 4-12 weeks post-ACS who were divided into two groups: Those eligible for IPE administration according to the 2019 ESC/EAS guidelines for the Management of Dyslipidaemias and those not eligible. Cardiometabolic profile at discharge and the incidence of 3-point major adverse CV events [3P-MACE; non-fatal myocardial infarction (MI), non-fatal stroke, cardiac death] within 12 months were compared between groups RESULTS: A total of 1254 patients had their lipid profile evaluated 4-12 weeks post-discharge and the vast majority (97.1 %) were on statins. Of those, 25.6 % were eligible for IPE administration while among patients with diabetes mellitus (DM) the eligibility was higher (32.6 %). IPE-eligibility was associated with an adverse cardiometabolic profile (higher prevalence of DM, hypertension, obesity and atherogenic dyslipidemia) and an increased risk of non-fatal MI within 12 months (5.9 % vs. 3.1 %, p = 0.027), even after adjustment for potential confounders. Rates of 3P-MACE, non-fatal stroke and cardiac death were similar between subgroups CONCLUSION: Approximately 1 in 4 post-ACS patients fulfill IPE-eligibility criteria and face an increased risk of myocardial reinfarction within 12 months. Early administration of IPE may play an essential role in mitigating residual CV risk detected by high TGs.

01 Dec 2025·AMERICAN HEART JOURNAL

Utilization and spending on lipid lowering therapies in medicaid from 2018 to 2022

Article

Author: Wadhera, Rishi K ; Beschloss, Alexander ; Oseran, Andrew S

BACKGROUND:

To determine how utilization and spending on lipid lowering medications in Medicaid changed between 2018 and 2022.

METHODS:

Retrospective, cross-sectional study of utilization and spending on 32 lipid lowering drug formulations (18 brand-name, 14 generic) using the Medicaid Spending by Drug Dataset (2018-2022).

RESULTS:

The study included over 115 million prescription fills in the Medicaid program. Between 2018 and 2022, annual prescription fills for lipid lowering medications increased 1.2%, from 22.7 million per year to 22.9 million per year, while annual Medicaid spending on these medications increased 13.2%, from $348.3 million to $394.4 million per year. Annual statin utilization remained stable over the study period (20.4 million fills in 2018 compared to 20.3 million fills in 2022), while spending on statins decreased (from $243.9 million to $228.3 million). Conversely, annual prescription fills and spending for PCSK9 inhibitors (7,617 fills and $8.9 million to 121,737 fills and $65.7 million), icosapent ethyl (32,527 fills and $10.2 million to 180,291 fills and $50.2 million), and bempedoic acid (from 494 fills and $215,499 to 4,619 fills and $2.2 million) all increased between 2018 and 2022.

CONCLUSION:

Between 2018 and 2022, annual prescription fills for lipid lowering therapies in Medicaid remained stable while spending on these medications increased, driven by increased utilization of PCSK9 inhibitors, icosapent ethyl, and bempedoic acid. As Medicaid budgets face escalating financial pressure-and the burden of cardiovascular disease increases among low-income adults in Medicaid-it is critical that policymakers continue to monitor utilization and spending on existing and novel high-cost medical therapies.

01 Sep 2025·Comparative Biochemistry and Physiology D-Genomics & Proteomics

α-Ketoglutarate modulates the mechanisms of toxicity in crucian carp kidneys chronically exposed to NaHCO3: Metabolomics insights

Article

Author: Han, Lin ; Yuan, Fangying ; Liu, Wenzhi ; Liu, Qianwen ; Cheng, Hongyu ; Jin, Xiaofeng ; Sun, Yanchun

Due to the unique physicochemical properties of saline-alkaline water, aquatic organisms find it challenging to survive under such conditions. This study established a freshwater control group (C), a 20 mmol/L NaHCO₃ exposure group (T), a 40 mmol/L NaHCO₃ exposure group (F), a 20 mmol/L NaHCO₃ exposure with α-ketoglutarate (AKG)-supplemented feed group (TA), and a 40 mmol/L NaHCO₃ exposure with AKG-supplemented feed group (FA). Histopathological analysis, biochemical assays, and UPLC-QTOF/MS metabolomics were employed to explore the potential mechanisms by which AKG alleviates oxidative damage in freshwater teleosts induced by saline-alkaline stress. Histopathological results showed that as the concentration of carbonate alkali exposure increased, the severity of kidney lesions in crucian carp (Carassius auratus) worsened. However, in the TA and FA groups, the damage showed varying degrees of repair, with the kidney tissue morphology in the TA group almost restored to the state of the C group. Under carbonate alkali exposure, compared to the C group, the activity of antioxidant enzymes Catalase and Superoxide dismutase in crucian carp kidneys decreased in a dose-dependent manner, but increased upon AKG supplementation. Conversely, the levels of Malondialdehyde, blood ammonia, Urea nitrogen, and Uric acid showed the opposite trend. Metabolomics analysis revealed that carbonate-alkali stress caused a series of metabolic disruptions in fish, including amino acid metabolism, lipid metabolism, and energy metabolism. AKG positively regulated metabolic pathways such as the pentose phosphate pathway, arachidonic acid metabolism, and amino acid metabolism, thereby enhancing the antioxidant, anti-inflammatory, and immune capabilities of fish under saline-alkaline stress, alleviating oxidative damage induced by the stress. Overall, our research indicates that saline-alkaline stress significantly alters kidney function and metabolic characteristics, disrupts the antioxidant system and energy homeostasis, inhibits protein catabolism, and induces kidney damage in crucian carp. Exogenous AKG supplementation effectively mitigates oxidative damage and metabolic disorders in crucian carp kidneys under carbonate-alkaline stress. This study elucidates the physiological mechanisms by which AKG alleviates kidney tissue damage under saline-alkaline stress at the metabolic level, providing scientific evidence for the development of aquaculture in saline-alkaline water.

150

News (Medical) associated with Icosapent Ethyl

14 Aug 2025

·hlstherapeutics.com

HLS Therapeutics Announces Q2 2025 Financial Results

Adjusted EBITDA grew 21% in Q2 and 29% year-to-date Cash from operations grew 83% in Q2 and 147% year-to-date Made principal repayments on the Company's long-term debt totalling $8.5 million Expanded cardiovascular portfolio by licensing Canadian rights to NEXLETOL® and NEXLIZET® from Esperion Therapeutics TORONTO, Aug. 14, 2025 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX: HLS), a pharmaceutical company focused on addressing unmet needs in the treatment of psychiatric disorders and cardiovascular disease, announces its financial results for the three and six months ended June 30, 2025 ("Q2 2025" and "year-to-date"). All amounts are in thousands of United States ("U.S.") dollars unless otherwise stated. Q2 & YEAR-TO-DATE 2025 FINANCIAL HIGHLIGHTS (comparisons are to the respective 2024 periods) Q2 2025 revenue was $14.2 million, Adjusted EBITDA1 was $5.2 million and cash from operations was $4.6 million, compared to $14.5 million, $4.3 million and $2.5 million, respectively. Year-to-date 2025 revenue was $26.8 million, Adjusted EBITDA was $9.0 million and cash from operations was $8.1 million, compared to $27 million, $7 million and $3.3 million, respectively. In local currency, combined Canadian product sales for Vascepa and Clozaril were flat in Q2 2025 and were up 6% year-to-date. US sales of Clozaril were up 1% in Q2 2025 and were up 2% year-to-date. Excluding cost of sales, operating expenses decreased 18% in Q2 2025 and 19% year-to-date. Vascepa made a positive contribution to Adjusted EBITDA in Q2 2025 for the third straight quarter. Q2 2025 CORPORATE HIGHLIGHTS Announced in-license agreement with Esperion Therapeutics Inc. (NASDAQ:ESPR) to commercialize NEXLETOL2 and NEXLIZET2 in Canada. Made principal repayments on the Company's long-term debt totalling $8.5 million. Repurchased $0.8 million of common stock in Q2 2025. Year-to-date, the Company has purchased $1.0 million of common stock at an average price of C$4.56 per share. "Our year-to-date results reflect continued execution on our key strategic priorities as we position the Company to resume its growth trajectory," said Craig Millian, Chief Executive Officer at HLS. "We remain on track to achieve full-year guidance, with strong underlying performance demonstrated by 29% year-to-date Adjusted EBITDA growth, robust cash flow generation, and continued balance sheet strengthening through significant debt repayments." "Looking ahead, we're excited to introduce NEXLETOL and NEXLIZET in Canada, addressing an important treatment need for at-risk Canadian patients. These medicines have the potential to more than double the size of our cardiovascular business and will further establish HLS as a leading Canadian-based company focused on cardiovascular risk reduction. With Health Canada approval expected by year-end and launch planned for Q2 2026, we believe HLS is well-positioned for our next phase of growth." Q2 & YEAR-TO-DATE 2025 FINANCIAL REVIEWThe Company's Management's Discussion and Analysis and Consolidated Financial Statements for the three and six months ended June 30, 2025, are available at the Company's website and at its profile at SEDAR+. Revenue Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024 Product sales Canada 10,521 10,637 20,229 19,791 United States 3,502 3,462 6,220 6,104 14,023 14,099 26,449 25,895 Royalty revenue 148 420 345 1,097 14,171 14,519 26,794 26,992 Revenue for Q2 2025 decreased 2%, due primarily to lower royalty revenues and FX rate fluctuations. Year-to-date 2025, revenue was essentially flat with 2% growth in product revenue being offset by a 69% drop in royalty revenue. Product sales – Canada 000's of CAD Three months ended June 30, Six months ended June 30, 2025 2024 % change 2025 2024 % change Clozaril 8,589 9,131 (5.9) % 16,518 16,996 (2.8) % Vascepa 5,884 5,407 8.8 % 11,862 9,878 20.1 % Other 76 14 108 27 14,549 14,552 0.0 % 28,488 26,901 5.9 % Canadian product sales in local currency were flat in Q2 2025 and up 6% year-to-date, compared to the same periods last year. The Q2 2024 period benefited from the timing of certain orders shifting from Q1 2024 because of the Easter holiday timing last year. For this reason, the Company views year-to-date revenue as a more relevant measure for the comparison of year-over-year revenue performance. Product Sales – United States In the U.S. market, Clozaril revenue for the three and six months ended June 30, 2025, increased 1% and 2%, respectively, compared to the same prior year periods. Royalty revenues As expected, following the sale of the Xenpozyme royalty interest in Q2 2024, royalty revenue has declined. Royalty revenue for the three and six months ended June 30, 2025, was down 65% and 69%, respectively, compared to the same periods last year. HLS has one remaining royalty interest which generated $0.15 million in revenue in Q2 2025. Operating Expenses Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024 Cost of product sales 2,505 2,303 4,903 4,077 Selling and marketing 3,046 4,561 5,876 9,087 Medical, regulatory and patient support 1,366 1,420 2,802 2,685 General and administrative 2,084 1,977 4,223 4,178 9,001 10,261 17,804 20,027 Cost of product sales increased for the three and six months ended June 30, 2025, due primarily to higher Vascepa sales volumes. Operating expenses in Q2 2025, excluding cost of product sales, decreased by 18% compared to Q2 2024, and by 19% for the year-to-date period. This was primarily due to lower selling and marketing expenses following the Company's discontinuation of co-promotional activities with its marketing partner in August 2024. While selling and marketing expenses will remain below 2024 levels throughout the year, quarterly selling and marketing expenses are expected to be moderately higher for the remainder of 2025 as several staff vacancies have now been filled. Adjusted EBITDA1 Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024 Net loss for the period (2,741) (5,682) (7,177) (11,788) Stock-based compensation 465 427 1,116 683 Amortization and depreciation 5,483 5,856 10,843 11,775 Finance and related costs, net 1,690 2,942 3,662 5,609 Other costs 31 (3,361) 327 (3,361) Income tax expense 242 4,076 219 4,047 Adjusted EBITDA 5,170 4,258 8,990 6,965 Adjusted EBITDA for the three and six months ended June 30, 2025, increased 21% and 29%, respectively, compared to the same periods last year. The increases were primarily due to steady performance from the Company's marketed products and the ongoing focus on cost management and were partially offset by FX fluctuations and the previously mentioned decline in royalty revenue. Excluding royalty revenue, Adjusted EBITDA for the three and six months ended June 30, 2025, would have increased 31% and 47%, respectively, compared to the same periods last year. In Q2 2025, the direct brand contribution from Clozaril to Adjusted EBITDA was $7.1 million, while the direct brand contribution from Vascepa to Adjusted EBITDA improved from negative $1.6 million in Q2 2024 to positive $0.1 million. Year-to-date, the direct brand contribution from Clozaril to Adjusted EBITDA was $12.9 million, while the direct brand contribution from Vascepa to Adjusted EBITDA improved from negative $3.2 million to positive $0.1 million. Net LossQ2 2025 net loss was ($2.7) million, or ($0.09) per share, compared to a net loss of ($5.7) million, or ($0.18) per share, in Q2 2024. Year-to-date net loss was ($7.2) million, or ($0.23) per share, compared to a net loss of ($11.8) million, or ($0.37) per share, in the same period last year. Net loss improved in both periods of 2025 due primarily to the previously noted factors that have positively impacted Adjusted EBITDA this year. Cash from Operations and Financial PositionCash generated from operations for the three and six months ended June 30, 2025, was $4.6 million and $8.1 million, compared to $2.5 million and $3.3 million in the same periods last year. This represents year-over-year increases of 83% and 147%, respectively. Total borrowings under the credit agreement at June 30, 2025, were $56.0 million compared to $67.4 million at December 31, 2024, and $84.9 million at June 30, 2024. This represents a reduction of 34% from June 30, 2024. During Q2 2025, HLS made principal payments on its term loan totaling $8.5 million and spent $0.8 million to purchase shares for cancellation under its Normal Course Issuer Bid. Year-to-date, HLS has made debt principal repayments of $11.4 million and under its share buyback program, has purchased 308,928 shares at a cost of $1 million since launching the buyback on March 17, 2025. Cash was $12.2 million at June 30, 2025, compared to $17.5 million at December 31, 2024. The decrease reflects the debt principal repayments, and the share buyback activity described previously, offset, in part, by the significant increase in cash from operations. 2025 OUTLOOKRevenue projections for the Company's Canadian product portfolio are denominated in local currency to account for ongoing FX rate fluctuations. 2025 financial targets are unchanged and as follows: Vascepa revenue of C$26.5-28.5 million (18-26% growth) Canada Clozaril sales of C$35.5-36 million (flat year-over-year) U.S. Clozaril sales of $12-12.3 million (2-4% decline) Royalty revenue of $0.6-0.75 million (50-60% decline) Consolidated Adjusted EBITDA of $19.5-20.5 million (17-23% growth) Future results could be impacted by continued exchange rate volatility. Q2 2025 CONFERENCE CALLHLS will hold a conference call today at 8:30 am Eastern Time to discuss its Q2 and year-to-date 2025 financial results. The call will be hosted by Mr. Craig Millian, CEO, Mr. John Hanna, CFO and Mr. Brian Walsh, CCO. To view the slides that accompany management's discussion, please use the webcast link. CONFERENCE ID: 66543 DATE: Thursday, August 14, 2025 TIME: 8:30 a.m. ET WEBCAST LINK: https://app.webinar.net/Zo9wjb9V5KR TRADITIONAL DIAL-IN NUMBER: 1-888-699-1199 or 1-416-945-7677 RAPIDCONNECT: To instantly join the conference call by phone, please use the following URL to easily register and be connected into the conference call automatically: https://emportal.ink/4kiYlSu TAPED REPLAY: 1-888-660-6345 or 1-289-819-1450 REPLAY CODE: 66543# The taped replay will be available for 14 days and the archived webcast will be available for 365 days. A link to the live audio webcast of the conference call will also be available on the events page of the investors section of HLS Therapeutics' website at www.hlstherapeutics.com. Please connect at least 15 minutes before the conference call to ensure enough time for any software download required to hear the webcast. ABOUT HLS THERAPEUTICS INC.Formed in 2015, HLS is a pharmaceutical company focused on the acquisition and commercialization of late-stage development, commercial stage promoted and established branded pharmaceutical products in the North American markets. HLS's focus is on products targeting the central nervous system and cardiovascular therapeutic areas. HLS's management team is composed of seasoned pharmaceutical executives with a strong track record of success in these therapeutic areas and at managing products in each of these lifecycle stages. For more information visit: www.hlstherapeutics.com 1CAUTIONARY NOTE REGARDING NON-IFRS MEASURESThis press release refers to certain non-IFRS measures. These measures are not recognized measures under IFRS, do not have a standardized meaning prescribed by IFRS and are therefore unlikely to be comparable to similar measures presented by other companies. Rather, these measures are provided as additional information to complement those IFRS measures by providing further understanding of HLS's results of operations from management's perspective. Accordingly, they should not be considered in isolation nor as a substitute for analysis of HLS's financial information reported under IFRS. HLS uses non-IFRS measures to provide investors with supplemental measures of its operating performance and thus highlight trends in its core business that may not otherwise be apparent when relying solely on IFRS financial measures. HLS also believes that securities analysts, investors and other interested parties frequently use non-IFRS measures in the evaluation of issuers. HLS's management also uses non-IFRS measures in order to facilitate operating performance comparisons from period to period, prepare annual operating budgets and assess HLS's ability to meet its future debt service, capital expenditure and working capital requirements. In particular, management uses Adjusted EBITDA as a measure of HLS's performance. To reconcile net income (loss) for the period with Adjusted EBITDA, each of (i) "stock-based compensation", (ii) "amortization and depreciation", (iii) "finance and related costs, net", (iv) "other costs (income)", and (v) "income tax expense (recovery)" appearing in the Consolidated Statement of Net Income (Loss) are added to net income (loss) for the period to determine Adjusted EBITDA. Adjusted EBITDA does not have any standardized meaning prescribed by IFRS and is not necessarily comparable to similar measures presented by other companies. Adjusted EBITDA should not be considered in isolation or as a substitute for net income (loss) prepared in accordance with IFRS as issued by the IASB. REFERENCES2: NEXLETOL® (bempedoic acid) and NEXLIZET® (bempedoic acid and ezetimibe) are the commercial brand names in the U.S. The brand names in Canada are to be confirmed upon approval by Health Canada. FORWARD LOOKING INFORMATIONThis release includes forward-looking statements regarding HLS and its business. Such statements are based on the current expectations and views of future events of HLS's management. In some cases the forward-looking statements can be identified by words or phrases such as "may", "will", "expect", "plan", "anticipate", "intend", "potential", "estimate", "believe" or the negative of these terms, or other similar expressions intended to identify forward-looking statements, including, among others, statements with respect to HLS's pursuit of additional product and pipeline opportunities in certain therapeutic markets, statements regarding growth opportunities, expectations regarding financial performance, and the NCIB and ASPP. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting HLS, including risks relating to the specialty pharmaceutical industry, risks related to the regulatory approval process, economic factors and many other factors beyond the control of HLS. Forward-looking statements and information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause HLS's actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statement or information. Accordingly, readers should not place undue reliance on any forward-looking statements or information. A discussion of the material risks and assumptions associated with this release can be found in the Company's Annual Information Form dated March 12, 2025, and Management's Discussion and Analysis dated August 13, 2025, both of which have been filed on SEDAR+ and can be accessed at www.sedarplus.ca. Accordingly, readers should not place undue reliance on any forward-looking statements or information. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and HLS undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. HLS THERAPEUTICS INC. INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION Unaudited [in thousands of U.S. dollars] As at As at June 30, 2025 December 31, 2024 ASSETS Current Cash 12,153 17,456 Accounts receivable 8,968 7,454 Inventories 6,823 9,058 Income taxes recoverable 80 71 Other current assets 2,011 1,361 Total current assets 30,035 35,400 Property, plant and equipment 1,048 997 Intangible assets 116,047 122,122 Deferred tax asset 1,386 857 Other non-current assets 556 528 Total assets 149,072 159,904 LIABILITIES AND SHAREHOLDERS' EQUITY Current Accounts payable and accrued liabilities 8,339 8,709 Provisions 11,814 8,367 Debt and other liabilities 7,025 5,317 Income taxes payable 411 152 Total current liabilities 27,589 22,545 Debt and other liabilities 50,799 61,944 Deferred tax liability 4,125 4,074 Total liabilities 82,513 88,563 Shareholders' equity Share capital 258,063 260,595 Contributed surplus 14,788 15,136 Accumulated other comprehensive loss (6,458) (10,210) Deficit (199,834) (194,180) Total shareholders' equity 66,559 71,341 Total liabilities and shareholders' equity 149,072 159,904 HLS THERAPEUTICS INC. INTERIM CONSOLIDATED STATEMENTS OF LOSS Unaudited [in thousands of U.S. dollars, except per share amounts] Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024 Revenue 14,171 14,519 26,794 26,992 Expenses Cost of product sales 2,505 2,303 4,903 4,077 Selling and marketing 3,046 4,561 5,876 9,087 Medical, regulatory and patient support 1,366 1,420 2,802 2,685 General and administrative 2,084 1,977 4,223 4,178 Stock-based compensation 465 427 1,116 683 Amortization and depreciation 5,483 5,856 10,843 11,775 Finance and related costs, net 1,690 2,942 3,662 5,609 Other costs (income) 31 (3,361) 327 (3,361) Loss before income taxes (2,499) (1,606) (6,958) (7,741) Income tax expense 242 4,076 219 4,047 Net loss for the period (2,741) (5,682) (7,177) (11,788) Net loss per share: Basic and diluted $(0.09) $(0.18) $(0.23) $(0.37) HLS THERAPEUTICS INC. INTERIM CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS Unaudited [in thousands of U.S. dollars] Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024 Net loss for the period (2,741) (5,682) (7,177) (11,788) Item that may be reclassified subsequently to net loss Unrealized foreign currency translation adjustment 3,440 (963) 3,752 (3,336) Comprehensive income (loss) for the period 699 (6,645) (3,425) (15,124) HLS THERAPEUTICS INC. INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY Unaudited [in thousands of U.S. dollars] Share capital Contributed surplus Accumulated other comprehensive loss Deficit Total Balance as at December 31, 2024 260,595 15,136 (10,210) (194,180) 71,341 Shares repurchased (2,532) — — 1,523 (1,009) Change in share purchase obligation — (878) — — (878) Stock option expense — 530 — — 530 Net loss for the period — — — (7,177) (7,177) Unrealized foreign currency translation adjustment — — 3,752 — 3,752 Balance as at June 30, 2025 258,063 14,788 (6,458) (199,834) 66,559 Balance as at December 31, 2023 262,127 13,865 (2,838) (175,457) 97,697 Shares repurchased (1,532) — — 932 (600) Change in share purchase obligation — 300 — — 300 Stock option expense — 433 — — 433 Net loss for the period — — — (11,788) (11,788) Unrealized foreign currency translation adjustment — — (3,336) — (3,336) Balance as at June 30, 2024 260,595 14,598 (6,174) (186,313) 82,706 HLS THERAPEUTICS INC. INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS Unaudited [in thousands of U.S. dollars] Three months ended June 30, Six months ended June 30, 2025 2024 2025 2024 OPERATING ACTIVITIES Net loss for the period (2,741) (5,682) (7,177) (11,788) Adjustments to reconcile net loss to cash provided by operating activities Stock-based compensation 465 427 1,116 683 Amortization and depreciation 5,483 5,856 10,843 11,775 Gain on royalty sale — (3,381) — (3,381) Accreted interest expense 302 277 610 559 Fair value adjustment on financial assets and liabilities — 318 — 505 Deferred income taxes (189) 3,861 (478) 3,800 Net change in non-cash working capital balances related to operations 1,284 843 3,233 1,144 Cash provided by operating activities 4,604 2,519 8,147 3,297 INVESTING ACTIVITIES Intangible asset acquisition (1,000) — (1,000) — Additions to property, plant and equipment (87) — (108) (2) Proceeds from royalty sale — 13,250 — 13,250 Cash provided by (used in) investing activities (1,087) 13,250 (1,108) 13,248 FINANCING ACTIVITIES Shares repurchased (833) (317) (1,009) (600) Repayment of credit agreement borrowing (8,481) (1,493) (11,441) (3,568) Debt costs — (658) — (1,191) Lease payments (151) (112) (294) (255) Cash used in financing activities (9,465) (2,580) (12,744) (5,614) Net increase (decrease) in cash during the period (5,948) 13,189 (5,705) 10,931 Foreign currency translation 367 (117) 402 (368) Cash, beginning of period 17,734 19,443 17,456 21,952 Cash, end of period 12,153 32,515 12,153 32,515 SOURCE HLS Therapeutics Inc.

Financial Statement

02 Jul 2025

·hlstherapeutics.com

HLS Therapeutics Announces Reimbursement for Vascepa® under Nova Scotia's Provincial Drug Plan

Vascepa is now available to more than 95% of Canadians who are eligible and covered by a public plan or private insurance TORONTO, July 2, 2025 /CNW/ - HLS Therapeutics Inc. ("HLS" or the "Company") (TSX: HLS), a pharmaceutical company focusing on addressing unmet needs in the treatment of psychiatric disorders and cardiovascular disease, announces that it has entered into a Product Listing Agreement ("PLA") with the province of Nova Scotia, for the listing and public reimbursement of Vascepa (icosapent ethyl). The PLA with Nova Scotia Pharmacare is effective July 1, 2025. Under the terms of the PLA, Vascepa will be reimbursed as an exception status product by the Nova Scotia formulary for the secondary prevention of cardiovascular events (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, coronary revascularization or hospitalization for unstable angina) in statin-treated patients with established cardiovascular disease and elevated triglycerides. "The PLA with Nova Scotia Pharmacare will significantly improve access and reimbursement for Vascepa in Atlantic Canada," said Craig Millian, CEO of HLS. "This milestone, combined with the recent in-licensing of two new products into our cardiovascular portfolio, supports our efforts to position HLS as a leading Canadian-based company focused on reducing cardiovascular risk for Canadians." Vascepa is now available to more than 95% of eligible patients covered by public plans and private insurance in Canada. ABOUT VASCEPA (ICOSAPENT ETHYL) CAPSULES Vascepa capsules are the first-and-only prescription treatment comprised solely of the active ingredient, icosapent ethyl (IPE), a unique form of eicosapentaenoic acid. Vascepa was approved by Health Canada and added to Health Canada's Register of Innovative Drugs and benefits from data protection for a term of eight years, as well as being the subject of multiple issued and pending patents based on its unique clinical profile. HLS in-licensed the exclusive rights to Vascepa for the Canadian market from Amarin Corporation (NASDAQ:AMRN). ABOUT HLS THERAPEUTICS INC. Formed in 2015, HLS is a pharmaceutical company focused on the acquisition and commercialization of late-stage development, commercial stage promoted and established branded pharmaceutical products in the North American markets. HLS's focus is on products targeting the central nervous system and cardiovascular therapeutic areas. HLS's management team is composed of seasoned pharmaceutical executives with a strong track record of success in these therapeutic areas and at managing products in each of these lifecycle stages. For more information visit: www.hlstherapeutics.com FORWARD LOOKING INFORMATION This release includes forward-looking statements regarding HLS and its business. Such statements are based on the current expectations and views of future events of HLS's management. In some cases the forward-looking statements can be identified by words or phrases such as "may", "will", "expect", "plan", "anticipate", "intend", "potential", "estimate", "believe" or the negative of these terms, or other similar expressions intended to identify forward-looking statements, including, among others, statements with respect to HLS's pursuit of additional product and pipeline opportunities in certain therapeutic markets, statements regarding growth opportunities and expectations regarding financial performance. The forward-looking events and circumstances discussed in this release may not occur and could differ materially as a result of known and unknown risk factors and uncertainties affecting HLS, including risks relating to the specialty pharmaceutical industry, risks related to the regulatory approval process, economic factors and many other factors beyond the control of HLS. Forward-looking statements and information by their nature are based on assumptions and involve known and unknown risks, uncertainties and other factors which may cause HLS's actual results, performance or achievements, or industry results, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statement or information. Accordingly, readers should not place undue reliance on any forward-looking statements or information. A discussion of the material risks and assumptions associated with this release can be found in the Company's Annual Information Form dated March 12, 2025, and Management's Discussion and Analysis dated May 7, 2025, both of which have been filed on SEDAR+ and can be accessed at www.sedarplus.ca. Accordingly, readers should not place undue reliance on any forward-looking statements or information. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and HLS undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise. SOURCE HLS Therapeutics Inc.

Drug Approval

24 Jun 2025

·www.fiercepharma.com

Amarin sells heart pill Vascepa's rights in Europe to Recordati amid restructuring bid

Paying $25 million upfront and potential milestones of $150 million, Recordati will take over commercialization of Amarin's heart-helping drug Vascepa in Europe. With sales of its lone product in a precipitous decline in the United States, Amarin has turned to an experienced local partner to boost them in Europe.Amarin has forged a licensing deal with Italian pharma Recordati to commercialize its fish oil-derived heart pill Vascepa in Europe, where the drug is known as Vazkepa. Recordati will pay $25 million upfront to market the product to 59 European countries. Recordati also is on the hook for $150 million in potential milestone payments, tied to specific annual sales targets, and for supply-based royalties.With the move, Amarin's share price increased by 31%.Amarin’s sales of Vascepa have plummeted since it caved to generic competition in the U.S. in 2020, just three months after the FDA granted it what seemed to be a game-changing label expansion to reduce cardiovascular risks. After Amarin’s revenue peaked at $614 million in 2020, it has fallen every year since. In 2024, the company reported sales of $229 million.With Vazkepa’s patent protection in place in Europe until 2039, Amarin believes the product still can thrive with the help of an established partner. Amarin has been marketing Vazkepa as a treatment added to statins for patients who are at risk of a cardiovascular event.“We know from our experience, in particular from the U.S., and from the clinical profile of Vazkepa, that there is significant opportunity or growth because of the unmet need (in Europe),” Amarin CEO Aaron Berg said during a conference call on Tuesday.Over the last few years, Amarin has attempted to build a market in Europe but with little success. In the fourth quarter of last year, the company reported just $4 million of its $62 million revenue from Europe.“Even the biggest companies are challenged launching products in European countries,” Berg said. “It’s particularly difficult for a one-product company with no established infrastructure to start and build from scratch. It’s a long-term endeavor. This product has significant potential. But that also means it takes significant resources over a period of time.” The partnership will allow Amarin to “streamline its global operations, which further strengthens the Company’s financial position,” it said in the release.In addition, in the statement, the chairman of Amarin’s board, Odysseas Kostas, M.D., cited Recordati’s “experience in the cardiovascular space in Europe.” The company, which celebrates its 100th birthday next year, derives roughly 25% of its revenue from its cardiovascular portfolio. With the move, Amarin said it will save $70 million over the next 12 months. The company touted its “financial strength,” as it has nearly $300 million in cash and no debt, it said.“We’re sharpening our operational focus by restructuring the organization, which positions the company for greater future financial performance,” Berg said. “We continue to act in a proactive and decisive manner to identify and pursue additional strategic opportunities to drive shareholder value. Nothing is off the table.”

License out/inDrug Approval

100 Deals associated with Icosapent Ethyl

External Link

KEGG	Wiki	ATC	Drug Bank
D01892	Icosapent Ethyl	C10AX	DB08887

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diabetes Mellitus	South Korea	Alvogen Korea Co., Ltd.	22 May 2025
Pain	South Korea	RP Bio, lnc.	21 Feb 2022
Ulcer	South Korea	RP Bio, lnc.	21 Feb 2022
Cardiovascular Diseases	United States	Amarin Pharmaceuticals Ireland Ltd.	13 Dec 2019
Hypertriglyceridemia	United States	Amarin Pharmaceuticals Ireland Ltd.	26 Jul 2012
Arteriosclerosis Obliterans	Japan	Mochida Pharmaceutical Co., Ltd.	15 Oct 1998
Hyperlipidemias	Japan	Mochida Pharmaceutical Co., Ltd.	05 Oct 1994

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Colonic Cancer	Phase 3	United Kingdom	Amarin Pharma, Inc.	02 May 2018
Liver metastases	Phase 3	United Kingdom	Amarin Pharma, Inc.	02 May 2018
Huntington Disease	Phase 3	United States	Amarin Neuroscience Ltd.	01 Sep 2005
Huntington Disease	Phase 3	Canada	Amarin Neuroscience Ltd.	01 Sep 2005
Nonalcoholic Steatohepatitis	Phase 2	United States	Mochida Pharmaceutical Co., Ltd.	01 Jun 2010
Nonalcoholic Steatohepatitis	Phase 2	Puerto Rico	Mochida Pharmaceutical Co., Ltd.	01 Jun 2010

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01492361 (REDUCE-IT, Pubmed \| J Am Heart Assoc) Manual	Phase 3	Cardiovascular Diseases LDL-C	8,175	Icosapent Ethyl 2g twice dailyIcosapent Ethyl 2g twice daily (LDL‐C <55 mg/dL)	fpszzkpjeu(bdapodkpav) = akvzjfjuxy lofjybivfz (ehyphgvzvx )	Positive	19 Feb 2025
				Placebo (LDL‐C <55 mg/dL)	fpszzkpjeu(bdapodkpav) = acqmkgpzrx lofjybivfz (ehyphgvzvx )
NCT02719327 (BRAVE-EPA, CTgov)	Phase 2/3	Alzheimer Disease	131	icosapent ethyl (Icosapent Ethyl (IPE))	lkenwxueao(vrxukilsff) = ptizfqnndo rzompgmtls (plvkujusol, 14.6) View more	-	26 Nov 2024
				gel cap placebo (Placebo)	lkenwxueao(vrxukilsff) = pfdfajmzxc rzompgmtls (plvkujusol, 14.1) View more
NCT05198843 (CTgov)	Phase 1/2	Metastatic breast cancer \| Metastatic Triple-Negative Breast Carcinoma	1	Dasatinib+EPA	gqldgkssru(hxgjtuqfcw) = hufunihyfx rbrvcphrxi (mshtkrzpro, rziaogxmio - bzioblcnho) View more	-	04 Sep 2024
NCT01492361 (REDUCE-IT, GlobeNewswire) Manual	Phase 3	Cardiovascular Diseases	-	Icosapent Ethyl (IPE) (Lp(a) ≥50 mg/dL)	pywzvcpfab(ftzhkcgdrh) = ffqatxdyki rrtgbxchcc (xknnqddbsm ) View more	Positive	06 Apr 2024
				Icosapent Ethyl (IPE) (Lp(a) <50 mg/dL)	pywzvcpfab(ftzhkcgdrh) = qaqtnpiieo rrtgbxchcc (xknnqddbsm ) View more
NCT01492361 (REDUCE-IT USA, Pubmed \| J Am Heart Assoc)	Phase 3	-	3,146	Icosapent Ethyl	cmulmbgblw(qwtvwkryms) = icjdoahvhp sdglkmngfb (ypmffajpym ) View more	-	02 Jan 2024
NCT01492361 (REDUCE-IT, GlobeNewswire) Manual	Phase 3	Cardiovascular Diseases \| Metabolic Syndrome	2,866	VASCEPA	aqalasyjrh(gbnkuxxybv): relative risk reduction = 29, P-Value = <0.0001; absolute risk reduction = 5.9 View more	Positive	12 Nov 2023
				placebo
NCT01492361 (REDUCE-IT, Pubmed)	Phase 3	Metabolic Syndrome	8,179	Icosapent ethyl 4 g/day	erkgydezbk(fuvhbbopae) = bgsmaqbybv sxwtzwekic (uhmvshezwb )	Positive	03 Nov 2023
NCT01492361 (REDUCE-IT, ESC2023)	Phase 3	-	-	Icosapent ethyl	lkbwhjwebe(emuwrhxxag) = jyboihbwli vxrbbrbudm (dkonuuwgpx, 1.8 - 8.7)	-	27 Aug 2023
				Placebo	lkbwhjwebe(emuwrhxxag) = ealykliyuz vxrbbrbudm (dkonuuwgpx, 1.9 - 9.4)
NCT01492361 (REDUCE-IT, Pubmed)	Phase 3	Atrial Fibrillation	8,179	Icosapent Ethyl	vndvazgtmm(zqealchuzu) = yojgeqntjd rncphvkeuo (bttmkooghy )	-	21 Feb 2023
				Placebo	vndvazgtmm(zqealchuzu) = xqwlzfbzlv rncphvkeuo (bttmkooghy )
NCT04221217 (Pubmed) Manual	Phase 3	Hypertriglyceridemia	122	MND-2119 (2 g/day)	lttxqflhuc(xbdbaurhmp) = qzntobhqco zmussoyewz (xrlyxgphxe ) View more	Positive	11 Sep 2022
				MND-2119 (4 g/day)	lttxqflhuc(xbdbaurhmp) = jzoyaktclv zmussoyewz (xrlyxgphxe ) View more

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