Autosomal dominant polycystic kidney disease (ADPKD), the most commonly inherited kidney disease, is characterized by the development of cysts in the kidney that impair function. Of those affected, half will progress to end-stage kidney disease by age 60, requiring dialysis or kidney transplant. To date, no effective and safe therapies exist for this deadly disease. Tolvaptan (Tol), the only FDA-approved drug for treatment of ADPKD, has some benefit in slowing kidney disease progression, but Tol causes frequent urination and thirst and also injures the liver in a small number of patients. The investigators' goal, therefore, is to develop new strategies to treat ADPKD that are safe and tolerable.
The development of cysts in ADPKD patients results from two main cellular processes. The first is cell growth with an increase in the number of kidney cells that make up the outer surface of the cyst. The second is an increase in fluid secretion into the cysts that develop. The investigators have shown that an enzyme, AMP-activated protein kinase (AMPK), when activated can inhibit both of those processes. Moreover, genetic mutations that cause ADPKD may alter the energy metabolism of the cell, which in turn inhibits AMPK activity. Bempedoic acid (BA), a medication that is FDA-approved for the treatment of individuals with high cholesterol and has a good safety record, activates AMPK. In addition to activating AMPK, BA inhibits a second enzyme called ATP-citrate lyase (ACLY), which is involved in cholesterol synthesis. ACLY has received growing attention as a novel target for cancer treatment. ACLY inhibition blocks increases of cell numbers by inhibiting the lipid synthesis that is required for creation of new cell membranes. This study will test whether targeting these pathways through treatment with BA will help reverse dysfunctional metabolism in individuals with ADPKD and slow disease progression.
The investigators will test this using a phase 2 clinical trial in which 120 individuals with rapidly progressive ADPKD and an estimated glomerular filtration rate of 35 or greater will be treated with either BA or placebo (inactive look-alike pill) for two years. Participants on or off a stable dose of Tol will be included in the study. Participants will be recruited from the U. of Vermont, U. of Maryland, and Tufts University, which have active PKD clinics and are recognized by the PKD Foundation as Centers of Excellence. Through follow-up visits and lab work, the investigators will assess the safety and tolerability of BA in the participants as the primary outcomes. The secondary goals are to assess preliminary efficacy and effects of BA on quality of life in study participants. The growth of cysts results in increased volume or size of the kidneys and liver. Total and cyst volumes of the kidney and liver and visceral abdominal fat content via magnetic resonance imaging (MRI) will be measured to gauge the effectiveness of this drug. The investigators also predict that proteins and small molecules involved in regulating cell energy metabolism, inflammation, and injury, as well as proteins directly involved in AMPK and ACLY function, will be altered in ADPKD patients. Levels of these proteins and small molecules may then subsequently change with BA therapy. Exploratory, mechanistic goals of this study are to identify prognostic and predictive urinary biomarkers in study participants. Successful completion of this study would have a significant impact on individuals with ADPKD by laying the groundwork for a new treatment strategy as well as by providing a new way to help guide treatment decisions.
In summary, the goals of this phase 2 randomized, double-blind, placebo-controlled clinical trial are to test the safety, tolerability and preliminary efficacy of the drug bempedoic acid, FDA-approved to lower cholesterol, when used in ADPKD patients.

Start Date21 Sep 2026

Sponsor / Collaborator

University of Vermont

[+5]

NCT07474649

/ Not yet recruitingPhase 3

Effects of Bempedoic Acid/Ezetimibe/High-intensity Statin on Plaque Regression and Stabilisation of Coronary Atherosclerosis Among Patients Without Cardiovascular Events

The overall objective of the trial is to evaluate the effect of the triple therapy consisting of bempedoic acid (BA), ezetimibe (EZE), and high-intensity atorvastatin or rosuvastatin on changes in coronary plaque burden and plaque morphology in patients with coronary atherosclerosis without significant obstructive coronary artery disease and without prior history of an ischemic vascular event.

Start Date15 Aug 2026

Sponsor / Collaborator

Daiichi Sankyo Co., Ltd.

CTRI/2026/06/111562

/ Not yet recruitingPhase 3

A Multicentric, Prospective, Active Controlled, Parallel Group, Randomized, Comparative, Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Fixed Dose Combination of Bempedoic Acid plus Atorvastatin Tablets in Patients for the Treatment of Hypercholesterolemia. - NIL

Start Date06 Jul 2026

Sponsor / Collaborator

Exemed Pharmaceuticals

100 Clinical Results associated with Bempedoic acid

100 Translational Medicine associated with Bempedoic acid

100 Patents (Medical) associated with Bempedoic acid

375

Literatures (Medical) associated with Bempedoic acid

31 Dec 2026·RENAL FAILURE

Emerging roles of ATP citrate lyase in kidney diseases: from pathogenic driver to therapeutic target

Review

Author: Yang, Yiya ; Chen, Yinyin ; Tao, Mina ; Wei, Mengjiao ; Li, Guoli ; Tan, Huifang ; Jin, Zhiyuan ; Xiao, Zheng

ATP-citrate lyase (ACLY) is a crucial cytosolic and nuclear enzyme that catalyzes the synthesis of acetyl-CoA from citrate, serving as a central metabolic node linking carbohydrate metabolism to de novo lipogenesis and histone acetylation. Accumulating evidence positions ACLY not merely as a metabolic enzyme but as a key pathogenic driver in various kidney diseases. This review systematically examines the multifaceted roles of ACLY in renal physiology and pathology. During development, ACLY is essential for nephron progenitor cell maintenance and nephrogenesis. In diabetic kidney disease, hyperglycemia upregulates and promotes nuclear translocation of ACLY, fueling histone acetylation and the transcription of pro-fibrotic genes, while also contributing to oxidative stress and lipid peroxidation. In obesity-related kidney injury, ACLY drives renal ectopic lipid accumulation and inflammation by providing substrates for adipogenic enzymes and inducing histone hyperacetylation. ACLY also promotes renal fibrosis in chronic kidney disease via pathways such as AKT/ACLY signaling. In clear cell renal cell carcinoma, ACLY expression is upregulated through HIF-2α/LPCAT1/FBXW7 and VHL/PPARγ axes, promoting lipid synthesis, tumor proliferation, and metastasis. Furthermore, ACLY activity influences hypocitraturia, a key factor in nephrolithiasis, and is upregulated in polycystic kidney disease, where its inhibition attenuates cystic growth. Given its central role across diverse renal pathologies, ACLY emerges as a promising therapeutic target. Several inhibitors, including bempedoic acid, SB-204990, and natural compounds, show potential in modulating ACLY activity. This review consolidates current knowledge on ACLY in kidney diseases, highlighting its mechanistic contributions, and underscoring its significant potential for diagnostic and therapeutic innovation.

01 Sep 2026·Atherosclerosis plus

Systematic literature review on the real-world effectiveness and safety of bempedoic acid

Review

Author: Gautam, Raju ; Ghatak, Aishee ; Anwar, Saeed ; Chhabra, Richa ; Cannon, Christopher P ; Powell, Heather A ; Sarnes, Evelyn ; Cicero, Arrigo Francesco Giuseppe ; Jawla, Shantanu

Background and aims:

Cardiovascular disease remains a significant global health burden. Bempedoic acid is a novel, oral adenosine triphosphate-citrate lyase inhibitor that lowers low-density lipoprotein cholesterol (LDL-C). While randomized controlled trials (RCTs) have established its efficacy and safety, evidence from real-world clinical practice is needed.

Methods:

A systematic literature review (SLR) was conducted to identify studies reporting real-world use of bempedoic acid as monotherapy, in fixed dose combination with ezetimibe, or in combination with any other lipid lowering therapy (LLT). MEDLINE, EMBASE, and Cochrane Library were searched from inception to February 19, 2025. Two reviewers independently screened studies, with discrepancies resolved by a third. Data extraction and validation were conducted, and the risk of bias assessed using the Newcastle-Ottawa Scale.

Results:

Of 269 records, 28 reports on 22 unique studies met the eligibility criteria. Most studies evaluated LDL-C changes from baseline after initiation of bempedoic acid; one pragmatic randomized trial was identified. Bempedoic acid achieved LDL-C reductions of 15% to 39% when added to maximally tolerated statins, 22% to 38% in statin intolerant cohorts, and 18% to 42% in mixed statin intolerant cohorts. Safety data was limited; treatment discontinuation ranged from 9% to 36%, with higher rates in cohorts with greater statin-intolerance.

Discussion:

This SLR shows bempedoic acid, with or without other LLTs, achieves a minimum of approximately 20% LDL-C reductions, consistent with RCTs. Data suggests it may be effective as an adjunct to statins and as an oral alternative for statin-intolerant patients.

07 Jul 2026·Journal of the American Heart Association

Efficacy and Safety of Bempedoic Acid in Patients Aged ≥75 Years Stratified by Varying Statin Exposure: Results From Phase 3 Studies of Bempedoic Acid

Article

Author: Mukherjee, Debabrata ; Nicholls, Stephen J. ; Leiter, Lawrence A. ; Catapano, Alberico L. ; Duell, P. Barton ; Nissen, Steven E. ; Laufs, Ulrich ; Bloedon, LeAnne ; Powell, Heather A. ; Lincoff, A. Michael ; Broestl, Christine ; Li, Na ; Goldberg, Anne C. ; Mancini, G. B. John ; Herout, Peter M. ; Banach, Maciej

Background:

Lowering low‐density lipoprotein cholesterol (LDL‐C) reduces the risk of major vascular events across all age groups. We analyzed phase 3 studies of bempedoic acid to characterize the safety and efficacy in patients aged ≥75 years with and without a concomitant statin.

Methods:

Post hoc analysis of bempedoic acid in high‐risk patients with cardiovascular disease by age from phase 3 placebo‐controlled, randomized clinical trials: two 52‐week primary hyperlipidemia studies with maximal background statin (“max‐statins pool”), and 1 cardiovascular outcomes trial (“statin‐intolerant pool”). Efficacy (LDL‐C, non–high‐density lipoprotein cholesterol, total cholesterol, high‐sensitivity C‐reactive protein) and safety were evaluated.

Results:

The max‐statins pool included 3009 (2010 bempedoic acid, 999 placebo) patients. The statin‐intolerant pool included 13 970 patients (6992 bempedoic acid, 6978 placebo). In total 7022 patients were aged 18 to <65 years; 7372 were aged 65 to <75 years; 2585 were aged ≥75 years. Placebo‐corrected mean percentage change in LDL‐C at week 12 in the max‐statin pool with bempedoic acid was −18.4% (95% CI, −21.3 to −15.6) for patients aged 18 to <65 years, −18.6% (95% CI, −21.2 to −16.1) for 65 to <75 years, and −18.3% (95% CI, −22.2 to −14.5) for ≥75 years. In the statin‐intolerant pool, LDL‐C change was −21.9% (95% CI, −23.1 to −20.7) for patients aged 18 to <65 years, −22.9% (95% CI, −24.0 to −21.8) for 65 to <75 years, and −24.5% (95% CI, −26.2 to −22.7) for ≥75 years. Frequency of adverse events compared with placebo was similar across the ages, but more frequent among patients ≥75 years regardless of background statin. Cardiovascular event reduction was statistically comparable across all ages.

Conclusions:

Bempedoic acid was well tolerated in patients aged ≥75 years with efficacy and safety comparable with younger subgroups regardless of background statin usage. Bempedoic acid may be considered a viable strategy for managing hypercholesterolemia in adults, regardless of age.

152

News (Medical) associated with Bempedoic acid

12 Aug 2026

·www.biospace.com

HLS Therapeutics Announces Q2 2026 Financial Results

Cardiovascular portfolio net sales grew 25% year-over-year, driving Q2 consolidated revenue growth of 3.5% NILEMDO™ reimbursement secured with the largest private payers in Canada, plus a unanimous positive CDA-AMC recommendation supporting public reimbursement Cash from operations of $9.3 million year-to-date, up 14% year-over-year; net debt reduced to $28.5 million, down 26% from December 31, 2025 TORONTO , Aug. 12, 2026 /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, 2026. All amounts are in thousands of United States ("U.S.") dollars unless otherwise stated. Q2 & YTD F2026 FINANCIAL HIGHLIGHTS (comparisons are to the respective 2025 period) Q2 2026 revenue was $14.7 million, Adjusted EBITDA was $4.7 million and cash from operations was $2.9 million, compared to $14.2 million, $5.2 million and $4.6 million, respectively. Year-to-date 2026 revenue was $27.5 million, Adjusted EBITDA was $8.1 million and cash from operations was $9.3 million, compared to $26.8 million, $9.0 million and $8.1 million, respectively. Vascepa net sales increased 18% in Q2 2026, the second consecutive quarter of double-digit growth. NILEMDO™ net sales exceeded $300 thousand in its first full quarter on the market. Q2 2026 Canadian Clozaril net sales narrowed to a 1% decline over prior year, supported by five consecutive months of growth in the patient base. Q2 2026 direct brand contribution from Clozaril to Adjusted EBITDA was $6.7 million ($12.4 million year-to-date), and the direct brand contribution from the cardiovascular portfolio, including incremental NILEMDO launch investment, was essentially breakeven in both the Q2 and year-to-date periods. CORPORATE HIGHLIGHTS NILEMDO full commercial launch took place in April. Reimbursement now secured with the largest private payers in Canada, representing approximately 80% of privately insured Canadians. Unanimous recommendation from Canada's Drug Agency (CDA-AMC) for reimbursement of NILEMDO by participating public drug plans. Launched a normal course issuer bid ("NCIB") in June 2026 for up to 1,500,000 common shares; through July 31, 2026, the Company has repurchased 339,880 shares, returning C$1.4 million to shareholders. Submitted responses to Health Canada's outstanding queries for NEXLIZET® in Q2 2026 and remain on track for an end of year decision and launch in the first half of 2027. "Our cardiovascular growth engine accelerated in the second quarter," said Craig Millian, Chief Executive Officer at HLS. "Our CV portfolio delivered 25% net sales growth, with Vascepa double-digit growth and NILEMDO ahead of plan in its first full quarter on the market. We also reached a significant milestone for NILEMDO, securing reimbursement with the largest private payers in Canada and a unanimous positive recommendation for reimbursement from Canada's Drug Agency, both important steps toward broad patient access. In Canada, our Clozaril patient base has now grown for five consecutive months, a positive sign that the business is stabilizing. With the strongest balance sheet in recent years and solid cash generation, we are investing in growing the Company while also returning capital to shareholders through our buyback." ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); "NILEMDO and NEXLIZET represent a significant growth opportunity for HLS," added Mr. Millian. "With an estimated half a million eligible Canadians, and with expanding private payer coverage and a positive public reimbursement recommendation in hand, we are well positioned to build on our early momentum. We plan to begin pCPA negotiations later this year, which we expect will support initial provincial listings in the first half of 2027. We expect the NEXLIZET launch to follow as an important addition to the armamentarium for physicians already writing NILEMDO. Along with the disciplined pursuit of business development opportunities, this gives HLS multiple paths to growth over the coming years." 2026 OUTLOOK HLS reaffirms its 2026 financial targets as follows: Consolidated revenue of $56-60 million, representing mid-single-digit percentage growth. Consolidated Adjusted EBITDA of $18.5-21 million, representing relatively flat year-over-year performance reflecting NILEMDO launch costs. Of note, future results could be impacted by continued exchange rate volatility. Mr. Millian added: "Our results through the first half of the year keep us on track against our 2026 guidance. We expect margins to expand as NILEMDO revenue continues to ramp through the back half of the year establishing momentum heading into 2027." Q2 F2026 FINANCIAL REVIEW The Company's Management's Discussion and Analysis and Consolidated Financial Statements for the three and six months ended June 30, 2026, are available at the Company’s website and at its pro SEDAR+ . Revenue Three months ended June 30, Six months ended June 30, 2026 2025 2026 2025 Product sales Canada 11,502 10,521 21,467 20,229 United States 2,966 3,502 5,619 6,220 14,468 14,023 27,086 26,449 Royalty revenue 205 148 451 345 14,673 14,171 27,537 26,794 Revenue for Q2 2026 increased 3.5% compared to Q2 2025, and increased 2.8% year-to-date compared to the same period of 2025. Both increases were driven by growth in Vascepa net sales as well as approximately $0.3 million in revenue from NILEMDO in its first full quarter on the market. Product sales – Canada 000's of CAD Three months ended June 30, Six months ended June 30, 2026 2025 % change 2026 2025 % change Clozaril 8,505 8,589 (1.0) % 15,521 16,518 (6.0) % Vascepa 6,940 5,884 17.9 % 13,492 11,862 13.7 % NILEMDO 427 -- 456 -- Other 58 76 127 108 15,930 14,549 9.5 % 29,596 28,488 3.9 % In local currency, Canadian product sales increased 9.5% in Q2 2026 and 3.9% year-to-date, reflecting strong Vascepa growth and the initial contribution from NILEMDO, partially offset by a modest decline in Clozaril. Vascepa's double-digit net sales growth in both Q2 and the year-to-date period reflects the changes made to the cardiovascular sales team in 2025. NILEMDO, in its first full quarter on the market, generated net sales slightly ahead of forecast, which is particularly encouraging given that meaningful private payer coverage only began taking effect late in the quarter. At the same time, Clozaril net sales in Canada were down just 1% in Q2 2026 compared to Q2 last year, a narrowing decline that reflects a patient base that has grown sequentially for five consecutive months, an encouraging early indicator for the balance of the year. Product Sales – United States In the U.S. market, Clozaril revenue in Q2 2026 and year-to-date declined compared to the same periods last year. The decrease was due in part to a slight decline in demand and also reflected a challenging Q2 year-over-year comparison, as the timing of the July 4 holiday in 2025 pulled some ordering into Q2 last year. The Company's specialty pharmacy program continues to help offset patient attrition, and this remains a high-margin, cash-generating business. Royalty revenues Royalty revenue for Q2 2026 was $0.2 million compared to $0.1 million in Q2 2025, and year-to-date was $0.5 million compared to $0.3 million in the same period last year. Operating Expenses Three months ended June 30, Six months ended June 30, 2026 2025 2026 2025 Cost of product sales 2,853 2,505 5,534 4,903 Selling and marketing 3,257 3,046 6,241 5,876 Medical, regulatory and patient support 1,704 1,366 3,213 2,802 General and administrative 2,196 2,084 4,423 4,223 10,010 9,001 19,411 17,804 Cost of product sales increased in Q2 2026 and year-to-date, due primarily to demand growth in Vascepa and initial sales of NILEMDO. Operating expenses, comprising sales and marketing, medical, regulatory and patient support, and G&A, were $7.2 million in Q2 2026, up 10% compared to Q2 last year, and up 8% year-to-date, reflecting the Company's investment in the NILEMDO launch. Adjusted EBITDA 1 Three months ended June 30, Six months ended June 30, 2026 2025 2026 2025 Net loss for the period (1,020) (2,741) (3,317) (7,177) Stock-based compensation 293 465 435 1,116 Amortization and depreciation 5,526 5,483 11,062 10,843 Finance and related costs, net (222) 1,690 (229) 3,662 Other costs 73 31 160 327 Income tax expense 13 242 15 219 Adjusted EBITDA 4,663 5,170 8,126 8,990 Adjusted EBITDA declined in Q2 2026 and year-to-date due to incremental investment related to the NILEMDO launch. As NILEMDO revenue increases in the coming quarters, the Company expects sequential Adjusted EBITDA growth, driven in part by margin expansion in the cardiovascular portfolio. Even with incremental NILEMDO launch investment and only one full quarter of sales, the direct brand contribution from the cardiovascular portfolio was breakeven for both the Q2 and year-to-date periods. For Q2 2026, the direct brand contribution from Clozaril to Adjusted EBITDA was $6.7 million, and for the year-to-date period was $12.4 million. Net Loss Q2 2026 net loss was $(1.0) million, or $(0.03) per share, compared to a net loss of $(2.7) million, or $(0.09) per share, in Q2 2025. Year-to-date net loss was $(3.3) million, or $(0.11) per share, compared to a net loss of $(7.2) million, or $(0.23) per share, in the same period of 2025. The improvement reflects lower finance and related costs and higher revenue, partially offset by incremental NILEMDO launch investment. Cash from Operations and Financial Position Cash generated from operations for Q2 2026 was $2.9 million compared to $4.6 million in Q2 2025. Year-to-date, cash from operations was $9.3 million, up 14% compared to $8.1 million in the same period last year, reflecting the operational improvements made over the past two-and-a-half years, along with significantly lower interest expense of $1.3 million year-to-date compared to $3.1 million in the same period last year. HLS continues to strengthen its balance sheet through disciplined capital allocation. In Q2 2026, the Company made a principal repayment of $1.1 million. At June 30, 2026, the principal balance on the Company's term loan stood at $42.2 million, down 16% from the end of 2025, and net debt stood at $28.5 million, down 26% from the end of 2025. Cash was $13.7 million at June 30, 2026, up from $11.7 million at December 31, 2025. Under its Normal Course Issuer Bid, launched in June 2026 for up to 1,500,000 common shares, the Company has purchased for cancellation 339,880 shares at a total cost of C$1.4 million through July 31, 2026. Q2 F2026 CONFERENCE CALL HLS will hold a conference call today at 10:00 am Eastern Time to discuss its Q2 2026 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: 73365 DATE: Wednesday, August 12, 2026 TIME: 10:00 a.m. ET WEBCAST LINK: 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: TAPED REPLAY: 1-888-660-6345 or 1-289-819-1450 REPLAY CODE: 73365# The taped replay will be available for seven days and the archived webcast will be available for 365 days. A link to the live audio webcast and replay of the conference call will also be available on the events page of the investors section of HLS Therapeutics' website at . 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 that address unmet needs in the treatment of psychiatric disorders and cardiovascular disease. 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: 1 CAUTIONARY NOTE REGARDING NON-IFRS MEASURES This 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 . 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, 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 11, 2026, and Management's Discussion and Analysis dated August 11, 2026, both of which have been filed on SEDAR+ and can be accessed at . 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 June 30, 2026 As at December 31, 2025 ASSETS Current Cash 13,730 11,723 Accounts receivable 8,507 7,862 Inventories 6,136 8,139 Other current assets 1,928 1,370 Total current assets 30,301 29,094 Property, plant and equipment 1,023 1,338 Intangible assets 95,415 105,626 Deferred tax asset 1,347 1,143 Other non-current assets 253 328 Total assets 128,339 137,529 LIABILITIES AND SHAREHOLDERS' EQUITY Current Accounts payable and accrued liabilities 8,186 10,438 Provisions 14,634 10,456 Debt and other liabilities 5,788 4,817 Income taxes payable 273 410 Total current liabilities 28,881 26,121 Debt and other liabilities 41,298 46,678 Deferred tax liability 2,924 3,060 Total liabilities 73,103 75,859 Shareholders' equity Share capital 256,298 256,338 Contributed surplus 15,342 16,164 Accumulated other comprehensive loss (8,964) (6,680) Deficit (207,440) (204,152) Total shareholders' equity 55,236 61,670 Total liabilities and shareholders' equity 128,339 137,529 HLS THERAPEUTICS INC. INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE INCOME (LOSS) Unaudited [in thousands of U.S. dollars, except per share amounts] Three months ended Six months ended June 30, June 30, 2026 2025 2026 2025 Revenue 14,673 14,171 27,537 26,794 Expenses Cost of product sales 2,853 2,505 5,534 4,903 Selling and marketing 3,257 3,046 6,241 5,876 Medical, regulatory and patient support 1,704 1,366 3,213 2,802 General and administrative 2,196 2,084 4,423 4,223 Stock-based compensation 293 465 435 1,116 Amortization and depreciation 5,526 5,483 11,062 10,843 Finance and related costs, net (222) 1,690 (229) 3,662 Other costs 73 31 160 327 Loss before income taxes (1,007) (2,499) (3,302) (6,958) Income tax expense 13 242 15 219 Net loss for the period (1,020) (2,741) (3,317) (7,177) Other comprehensive income (loss) Translation of foreign operations (1,253) 3,440 (2,284) 3,752 Comprehensive income (loss) for the period (2,273) 699 (5,601) (3,425) Net loss per share: Basic and diluted $(0.03) $(0.09) $(0.11) $(0.23) HLS THERAPEUTICS INC. INTERIM CONSOLIDATED STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY Unaudited [in thousands of U.S. dollars] Share capital Contributed surplus AOCI Deficit Total Balance, December 31, 2025 256,338 16,164 (6,680) (204,152) 61,670 Stock options exercised 5 (1) -- -- 4 Shares repurchased (45) -- -- 29 (16) Change in share purchase obligation -- (1,194) -- -- (1,194) Stock option expense -- 366 -- -- 366 RSU expense -- 7 -- -- 7 Net loss for the period -- -- -- (3,317) (3,317) Foreign currency translation adjustment -- -- (2,284) -- (2,284) Balance, June 30, 2026 256,298 15,342 (8,964) (207,440) 55,236 Balance, 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) Foreign currency translation adjustment -- -- 3,752 -- 3,752 Balance, June 30, 2025 258,063 14,788 (6,458) (199,834) 66,559 HLS THERAPEUTICS INC. INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS Unaudited [in thousands of U.S. dollars] Three months ended Six months ended June 30, June 30, 2026 2025 2026 2025 OPERATING ACTIVITIES Net loss for the period (1,020) (2,741) (3,317) (7,177) Adjustments to reconcile net loss to cash provided by operating activities Stock-based compensation 293 465 435 1,116 Amortization and depreciation 5,526 5,483 11,062 10,843 Accreted interest 99 302 205 610 Foreign exchange (956) -- (1,749) -- Deferred income taxes (271) (189) (340) (478) Changes in non-cash working capital balances related to operations (771) 1,284 2,971 3,233 Cash provided by operating activities 2,900 4,604 9,267 8,147 INVESTING ACTIVITIES Other intangible additions (60) -- (443) -- Capital expenditures -- (87) -- (108) Cash used in investing activities (60) (1,087) (443) (1,108) FINANCING ACTIVITIES Stock options exercised 4 -- 4 -- Shares repurchased (16) (833) (16) (1,009) Repayment of credit agreement borrowing (1,056) -- (6,155) -- Lease payments (159) (151) (321) (294) Cash used in financing activities (1,227) (9,465) (6,488) (12,744) Net change in cash in the period 1,613 (5,948) 2,336 (5,705) Foreign exchange (209) 367 (329) 402 Cash, beginning of period 12,326 17,734 11,723 17,456 Cash, end of period 13,730 12,153 13,730 12,153 SOURCE HLS Therapeutics Inc.

Financial Statement

10 Aug 2026

·www.biopharmadive.com

Scribe’s Benjamin Oakes on a rare IPO and bringing CRISPR to the masses

Gene editing company Scribe Therapeutics resides in two renovated buildings on the site of the former Alameda Works Shipyard in California. There's a layer of irony, Scribe CEO Benjamin Oakes says, in designing cutting-edge, microscopic gene modifying medicines where steelworkers once built and repaired 18,000-ton ships during World War II.Oakes' company is at the forefront of a wave of young biotechs aiming to bring CRISPR technology to the masses. Launched with the help of several accomplished genetic medicine researchers from the University of California, Berkeley, Scribe is working on treatments for the kind of cardiovascular conditions that affect millions of people. In papers outlining its recently priced initial public offering the first for a gene editing company in more than two years Scribe pitched plans to make the approach more scalable than it's ever been. Its first program “switches off“ a gene implicated in high cholesterol, rather than permanently altering it as some others do.But as Oakes scrawled in thick black marker at the bottom of a canvas in one of Scribe's conference rooms, “plan B is your plan A.“ Many gene editing companies have made similarly bold claims, only to face surprise setbacks in clinical testing that battered their stock prices. Investors and Wall Street analysts are also skeptical that people would embrace gene editing drugs in diseases where more conventional alternatives are available.Oakes spoke to BioPharma Dive about convincing investors not only to buy into gene editing, but believe in the potential of a medicine that would face considerable competition, if eventually approved.This interview has been condensed and lightly edited for clarity.BIOPHARMA DIVE: Several gene editing companies have struggled not just reaching the public markets, but growing their value afterwards. How, then, did you convince IPO investors to back Scribe?BENJAMIN OAKES: There's a design principle called MAYA it means most advanced yet acceptable. If you toe that line, but dont go past it, then all of a sudden it becomes okay. I want that most advanced thing. There's 1,000 different ways to build a cup, and I can build a really cool looking cup, but if I put wildly crazy things on it, like 10 handles, it may look like it's the cup of the future, but no one's going to want to use it because it doesn't feel accessible. So how do you build something that is more acceptable?Thats where epigenetic silencing really fits in. We have to develop almost a new framework for all of these approaches because the framework that we're finding is most important for medicine is human psychology. Human behavior drives how people are essentially interacting with their own health.How does that framework apply to making a new type of cholesterol drug?OAKES: We see this problem time and time again in LDL-C lowering, where there are incredibly good drugs. Statins have been around forever. Bempedoic acid exists, you can get combos of that. There are antibodies like Repatha, siRNAs like Leqvio, and now we have small molecules that are PCSK9 inhibitors. If you look at the stats, between 50 and 70% of those people are no longer taking [statins] within the first year.You have to take these drugs for a decade, two decades, probably four decades for most people. What's so interesting is this is not a drug problem anymore. This is a human behavior problem. We're not trying to solve for making a better drug necessarily. We're trying to solve for how we make human behavior interact well with our drugs.How do you see Scribe competing in an increasingly competitive field where different gene editing drugs from Eli Lilly and others are further along?Benjamin Oakes is the co-founder and CEO of Scribe Therapeutics.Permission granted by Scribe TherapeuticsOAKES: There's a very obvious difference between the medicines that are being created, and I think any individual patient, provider or payer can make those distinctions as they see fit. But the reality is right now, only 30% of people who should be on an LDL-C-lowering medication are. The number is so large that almost all we have to do is provide more options.This isn't about competition; I want Verve [Therapeutics] and Lilly to be as wildly successful as they can, because we're going to be providing something similar, but distinct, that can broaden accessibility in the patient population. While this market seems like it's well-served, it's so wildly underserved, and in many instances, unserved.You've said previously that you think the future of medicine is preventive, rather than reactive. Where do you see Scribe's work fitting in?OAKES:My goal is to try to build a drug that ultimately can be thought of as a preventative medicine to help people avoid cardiovascular disease risk. How do we give cardio-protective genetics to everybody, and how do we make that as broadly accessible as possible?Everyone's very focused on longevity research; this concept of if we can just reprogram the whole body, we could all stay useful. That's all well and good, and there's a lot of exciting things that you might be able to do with epigenetic tools like we build.But theres also the pragmatic engineer in me that says that science is not yet proven. I can't say that it's never going to happen. We don't know that it exists and, or how it exists. I'm sure that at some point we'll learn more. In front of us is a very real way to lengthen a lifespan for everybody. Treat the leading cause of morbidity and mortality globally.Why did you choose to go public now, rather than raise more private financing?OAKES: Were the first in vivo gene editing company to be in the clinic at the time of IPO. We knew we were going to get to the clinic [with our first drug], we also knew we had the second and third asset. It was time to accelerate not only the success we were having on the first asset, but accelerate the second and third asset into the clinic. We want to build essentially the box set, if you will, of approaches to address cardiovascular lipid risk. We also wanted to allow folks the opportunity to join us in a way that was meaningful.We thought the best way to do that would be once we get into the clinic, and we were less than a year from clinical data, to go and ask the question: Is our profile as an organization that has been incredibly capital efficient for a very long time, and very reasonable in our approaches, one that you want to support? And I think we were really pleased at the reception to that.The median IPO this year has hovered around $300 million, and the biggest offerings have surpassed $600 million. Scribe raised far less, by comparison. What do you attribute that difference to?OAKES: We try to be very disciplined and focused with how we run.We licensed molecules from Berkeley that did not work, that edited the genome less than 1%. We spent the past eight years iterating on these molecules year after year in the stepping stone evolution approach.We're not getting awards for improving our molecule's potency by 50% every year. But when I improve my potency 50% every year, you get this compounding interest in something like potency and specificity that starts to become really meaningful for the therapeutic window.We're trying to bridge the gap between where CRISPR molecules are, as bacterial immune systems, and where they should be, as therapeutics.Many people have, and should have, concerns. Previous organizations, some of which no longer even exist, have done things wrong, and it's very easy for an investor to paint a broad brush.The same thing could have been said about antibodies or RNAi companies back in the day. Just because you could create an easy gestalt of how you might think these things could work, doesn't mean that the specific organizations like ourselves fit within that picture. We can go and paint our own picture and say no, we can be highly focused. We can build therapeutics that have the chance to change how we think about the leading cause of disease globally. We can do so in a way that's focused and efficient, all those things come together. We can get into the clinic after having raised only $150 million in the past seven years. '

IPO

05 Aug 2026

·www.biospace.com

HLS Therapeutics Provides Update on NILEMDO™ Market Access

Reimbursement secured with the largest private payers in Canada, estimated to represent approximately 80% of privately insured Canadians Canada's Drug Agency issues final recommendation, with its expert committee voting unanimously to recommend reimbursement of NILEMDO™ by public drug plans TORONTO , Aug. 5, 2026 /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 positive developments in both private and public reimbursement coverage for NILEMDO™ (bempedoic acid) in Canada. Private Payer Coverage HLS has now secured reimbursement for NILEMDO with the largest private payers in Canada, representing approximately 80% of privately insured Canadians, the vast majority of whom can now access NILEMDO as a full benefit without restrictions. Several of these agreements are already in effect, with the remainder taking effect during the third quarter of 2026. Public Reimbursement On the public side, Canada's Drug Agency (CDA-AMC) has finalized its reimbursement recommendation for NILEMDO. The Canadian Drug Expert Committee voted unanimously to recommend that NILEMDO be reimbursed by participating public drug plans. This recommendation opens the window for HLS to begin negotiations with the pan-Canadian Pharmaceutical Alliance (pCPA) toward product listing agreements. HLS intends to commence those negotiations later this year, keeping it on track for initial provincial listings in the first half of 2027. A link to the CDA-AMC report can be found here: Bempedoic Acid (NILEMDO) "We are pleased with our progress on securing market access for NILEMDO," said Craig Millian, Chief Executive Officer at HLS. "For the many Canadians who are not reaching their LDL cholesterol targets on statins, whether due to intolerance or inadequate response, NILEMDO provides physicians and patients with a much-needed oral treatment option. Broad private coverage without restrictions, together with a clear pathway toward public reimbursement, means more Canadian patients will be able to access this medicine to help manage their cardiovascular risk." ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); ABOUT NILEMDO NILEMDO is indicated to reduce low-density lipoprotein cholesterol ("LDL-C") and the risk of major cardiovascular events in adults who require additional LDL-C lowering due to an inability to reach target levels with currently available therapies or due to statin intolerance. HLS in-licensed the exclusive rights to NILEMDO and NEXLIZET® (bempedoic acid and ezetimibe combination) for the Canadian market from Esperion Therapeutics, Inc. 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 treatment of psychiatric disorders and cardiovascular disease. 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: 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, 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. A discussion of the material risks and assumptions associated with this release can be found in the Company's Annual Information Form dated March 11, 2026, and Management's Discussion and Analysis dated May 14, 2026, both of which have been filed on SEDAR+ and can be accessed at . 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.

License out/in

100 Deals associated with Bempedoic acid

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KEGG	Wiki	ATC	Drug Bank
D10691	Bempedoic acid	C10AX15	DB11936

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Hyper LDL cholesterolaemia	Canada	HLS Therapeutics, Inc.	05 Mar 2026
Hypercholesterolemia	Japan	大塚製薬株式会社	19 Sep 2025
Cardiovascular Diseases	United States	Esperion Therapeutics, Inc.	22 Mar 2024
Myocardial Infarction	United States	Esperion Therapeutics, Inc.	22 Mar 2024
Primary Hyperlipidemia	United States	Esperion Therapeutics, Inc.	22 Mar 2024
Dyslipidemias	European Union	Daiichi Sankyo Europe GmbH	01 Apr 2020
Dyslipidemias	Iceland	Daiichi Sankyo Europe GmbH	01 Apr 2020
Dyslipidemias	Liechtenstein	Daiichi Sankyo Europe GmbH	01 Apr 2020
Dyslipidemias	Norway	Daiichi Sankyo Europe GmbH	01 Apr 2020
Primary hypercholesterolemia	European Union	Daiichi Sankyo Europe GmbH	01 Apr 2020
Primary hypercholesterolemia	Iceland	Daiichi Sankyo Europe GmbH	01 Apr 2020
Primary hypercholesterolemia	Liechtenstein	Daiichi Sankyo Europe GmbH	01 Apr 2020
Primary hypercholesterolemia	Norway	Daiichi Sankyo Europe GmbH	01 Apr 2020
Atherosclerosis	United States	Esperion Therapeutics, Inc.	21 Feb 2020
Heterozygous familial hypercholesterolemia	United States	Esperion Therapeutics, Inc.	21 Feb 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hyperlipidemias	Phase 3	United States	Esperion Therapeutics, Inc.	23 Oct 2017
Cerebrovascular Disorders	Phase 3	United States	Esperion Therapeutics, Inc.	22 Dec 2016
Cerebrovascular Disorders	Phase 3	Argentina	Esperion Therapeutics, Inc.	22 Dec 2016
Cerebrovascular Disorders	Phase 3	Australia	Esperion Therapeutics, Inc.	22 Dec 2016
Cerebrovascular Disorders	Phase 3	Austria	Esperion Therapeutics, Inc.	22 Dec 2016
Cerebrovascular Disorders	Phase 3	Belgium	Esperion Therapeutics, Inc.	22 Dec 2016
Cerebrovascular Disorders	Phase 3	Brazil	Esperion Therapeutics, Inc.	22 Dec 2016
Cerebrovascular Disorders	Phase 3	Bulgaria	Esperion Therapeutics, Inc.	22 Dec 2016
Cerebrovascular Disorders	Phase 3	Canada	Esperion Therapeutics, Inc.	22 Dec 2016
Cerebrovascular Disorders	Phase 3	Chile	Esperion Therapeutics, Inc.	22 Dec 2016

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05694260 (CLEAR Path 1, CTgov)	Phase 2	Heterozygous familial hypercholesterolemia	31	Bempedoic Acid (Cohort 1 (16 to <30 Kg) Bempedoic Acid 60 mg)	vsqsavmhkb(nkjxlhtrey) = mbfsvggkuh rwfkaedfht (wytnvrtvhi, 39.6) View more	-	17 Jul 2026
				Bempedoic Acid (Cohort 1 (16 to <30 Kg) Bempedoic Acid 90 mg)	vsqsavmhkb(nkjxlhtrey) = spabuhgwsd rwfkaedfht (wytnvrtvhi, 20.4) View more
NCT02993406 (CLEAR Outcomes, Pubmed \| JAMA Cardiol)	Phase 3	Venous Thromboembolism	13,970	Bempedoic acid	opkxaxabxy(jxaihmypbc) = ofajiofxsm dwozeuhwyl (fqvdbqzioy )	Positive	27 May 2026
				Placebo	opkxaxabxy(jxaihmypbc) = mxtsmmeljh dwozeuhwyl (fqvdbqzioy )
NCT06925100 (CLEAR Taiwan, Pubmed \| J Am Heart Assoc)	Phase 4	Hypercholesterolemia	180	Bempedoic acid	rbkfhsaomz(cyrrbepleq) = zujujbnoni nyfnnawdfn (gipmcoblkg )	Positive	19 May 2026
NCT05687071 (CTgov)	Phase 3	Hyper LDL cholesterolaemia	130	ETC-1002	ydgudhvfax = cqeuwlkctr pdtrzxdndk (wfjakzztal, cxyxfjafhp - btxfoawgef) View more	-	20 Feb 2026
NCT02993406 (CLEAR Outcomes, Pubmed \| Am J Cardiovasc Drugs)	Phase 3	Hypercholesterolemia	13,970	Bempedoic acid	kcepuzeyia(znzitqxopp) = wsnjxmznrq iqiuvhwgkl (qrsxkkxcth )	Positive	20 Aug 2025
				Placebo	kcepuzeyia(znzitqxopp) = crgrxpcujo iqiuvhwgkl (qrsxkkxcth )
NCT05683340 (CTgov)	Phase 3	Hyper LDL cholesterolaemia	96	Placebo	yggxovypqa(vsxlzyoogm) = vdetimcfna pgnpjafwsi (pzdoniabyd, 1.901) View more	-	13 Mar 2025
NCT02993406 (CLEAR Outcomes, Pubmed \| J Am Heart Assoc)	Phase 3	Obesity	6,177	Bempedoic Acid 180 mg	imcfhbzhaa(plqdpqfnye) = tdoevnuhhr rouixokiwt (bssvaozuob, 0.76 [0.63 - 0.92]) View more	Positive	18 Feb 2025
				Placebo	-
NCT05683340 (Company_Website) Manual	Phase 3	Hypercholesterolemia	96	Bempedoic acid 180 mg	ejetlsuemt(qyxstzotlf) = zxsppunpnu alifkpdfhc (jnhmhotmdp ) Met	Positive	20 May 2024
				Placebo	ejetlsuemt(qyxstzotlf) = nbvabpkywv alifkpdfhc (jnhmhotmdp ) Met
NCT04784442 (CTgov)	Phase 2	Hypercholesterolemia	188	Placebo	qhrmpvnqmo(ynebnguffp) = natqldgheg trdquzzgbq (lfhptokqla, 2.117) View more	-	04 Mar 2024
NCT02993406 (CLEAR Outcomes, CTgov)	Phase 3	Cardiovascular Diseases \| Coronary Artery Disease \| Cerebrovascular Disorders ... View more	13,970	Bempedoic acid 180 mg tablet (Bempedoic Acid 180 mg)	xjhfftjofc = pgjtyzyrkd aisajwwonp (fnllastuef, vumogrlmok - ypfhlndspy) View more	-	03 Jan 2024
				Matching placebo tablet (Placebo Comparator)	xjhfftjofc = fmbojodiuv aisajwwonp (fnllastuef, bgfcjfxsfc - npkokmjfhh) View more

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