Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanotide) for Patients with Acquired Hypothalamic Obesity

Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanotide) for Patients with Acquired Hypothalamic Obesity




Rhythm Pharmaceuticals Announces FDA Approval of IMCIVREE® (setmelanotide) for Patients with Acquired Hypothalamic Obesity

— First and only FDA-approved therapy for the treatment of acquired hypothalamic obesity, a rare disease characterized by accelerated and sustained weight gain caused by hypothalamic injury or dysfunction – 

— Indicated to reduce excess body weight and maintain reduction long term in adults and pediatric patients aged 4 years and older with acquired hypothalamic obesity —

— Approval based on -18.4% placebo-adjusted BMI reduction achieved by setmelanotide in global Phase 3 TRANSCEND trial [N=142] —

— Company to host conference call today at 7:00 p.m. ET —

BOSTON, March 19, 2026 (GLOBE NEWSWIRE) — Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a global commercial-stage biopharmaceutical company focused on transforming the lives of patients living with rare neuroendocrine diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for IMCIVREE® (setmelanotide) to treat patients living with acquired hypothalamic obesity (HO).

Acquired HO is a rare disease characterized by accelerated and sustained weight gain caused by an injury to the hypothalamus or hypothalamic dysfunction. With this label expansion, IMCIVREE is indicated to reduce excess body weight and maintain reduction long term in adults and pediatric patients aged 4 years and older with acquired HO.

“IMCIVREE is now the first and only FDA-approved therapy for acquired HO, offering a targeted approach that addresses the underlying biology of this disease and meets a critical unmet need for patients who previously had no treatment options,” said David Meeker, M.D., Chairman, Chief Executive Officer and President of Rhythm. “This is a transformative milestone for Rhythm and reinforces our commitment to bringing meaningful therapies to patients living with rare MC4R pathway diseases.”

The MC4R pathway is responsible for controlling physiological functions such as energy expenditure, hunger, and weight regulation. Acquired HO most frequently follows tumors and their treatment or other hypothalamic injury or dysfunction. Based on analysis of the literature, tumor registries and claims data, Rhythm estimates there are approximately 10,000 people living with acquired HO in the U.S.

“Having a therapy for individuals and families affected by acquired hypothalamic obesity has the potential to be transformational,” said Amy Wood, Executive Director and Founder of the Raymond A. Wood Foundation. “We’ve seen firsthand the devastating impact acquired hypothalamic obesity has on patients’ and families’ lives, including relentless hunger and accelerated and sustained weight gain. IMCIVREE offers hope and a path forward for thousands of patients who have long been without options.”

The approval is supported by the positive pivotal Phase 3 TRANSCEND trial of setmelanotide in 142 patients with acquired HO. The global study met its primary endpoint, with a statistically significant -18.4% placebo-adjusted reduction in body mass index (BMI). For the primary endpoint of mean BMI change from baseline, study participants on setmelanotide therapy (n=94) achieved a -15.8% reduction compared with a +2.6% increase among patients on placebo (n=48) at 52 weeks (p<0.0001). Setmelanotide was generally well tolerated in the Phase 3 trial. The most common adverse events (affecting >20% of participants) were skin hyperpigmentation, nausea, vomiting and headache.

“Setmelanotide has shown effectiveness in targeting the underlying biology of acquired HO,” said Ashley Shoemaker, M.D., MSCI, Associate Professor of Pediatrics, Pediatric Endocrinology at Vanderbilt Health. “Patients treated with setmelanotide experienced meaningful reductions in BMI and hunger, demonstrating the therapy’s ability to deliver clinically significant outcomes in both children and adult patients. Acquired HO is a severe disease that requires early and proactive management. With the availability of IMCIVREE, physicians can offer a targeted therapy.”

IMCIVREE® (setmelanotide) is also approved in the U.S. and Europe in adult and pediatric patients aged 2 years and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency.

Rhythm is committed to supporting access for patients to its medicines and IMCIVREE® (setmelanotide) will be available for patients in the U.S. immediately. Rhythm InTune provides personalized, ongoing educational support for individuals living with certain rare forms of obesity. The program is designed for patients seeking education for themselves and their health care providers, assistance with insurance navigation at treatment initiation, injection support, and guidance on what to expect throughout treatment. For more information, contact patientsupport@rhythmtx.com.

Conference Call Information
Rhythm will host a live conference call and webcast at 7:00 p.m. ET today to discuss the FDA approval of IMCIVREE for patients with acquired HO. To access the live conference call, participants may register here.

A live webcast of the event will be available under “Events and Presentations” in the Investor Relations section of the Rhythm Pharmaceuticals website at https://ir.rhythmtx.com/. The archived webcast will be available on Rhythm Pharmaceuticals’ website approximately two hours after the event and will be available for 30 days following the event. 

About Acquired Hypothalamic Obesity
Acquired hypothalamic obesity is a rare disease characterized by accelerated and sustained weight gain caused by an injury to the hypothalamus. Hypothalamic injury may lead to decreased alpha-melanocyte-stimulating hormone (α-MSH) production and impairment of MC4R pathway signaling. The MC4R pathway is responsible for regulating energy balance and body weight. Acquired hypothalamic obesity most frequently follows the growth or treatment of craniopharyngioma, astrocytoma or other hypothalamic-pituitary tumors. Additional causes of injury may include traumatic brain injury, stroke or inflammation. Due to impairment of the MC4R pathway, patients experience accelerated and sustained weight gain, often accompanied by hyperphagia and/or decreased energy expenditure. Acquired hypothalamic obesity can occur as early as six months following hypothalamic injury. Rhythm estimates there are approximately 10,000 people living with acquired HO in the U.S.

About Rhythm Pharmaceuticals
Rhythm is a commercial-stage biopharmaceutical company committed to transforming the lives of patients and their families living with rare neuroendocrine diseases. Rhythm’s lead asset, IMCIVREE® (setmelanotide), an MC4R agonist designed to treat hyperphagia and severe obesity, is approved by the U.S. Food and Drug Administration (FDA) to reduce excess body weight and maintain reduction long term in adults and pediatric patients aged 4 years and older with acquired hypothalamic obesity, adult and pediatric patients 2 years of age and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or genetically confirmed pro-opiomelanocortin (POMC), including proprotein convertase subtilisin/kexin type 1 (PCSK1), deficiency or leptin receptor (LEPR) deficiency. Both the European Commission (EC) and the UK’s Medicines & Healthcare Products Regulatory Agency (MHRA) have authorized setmelanotide for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or genetically confirmed loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. Additionally, Rhythm is advancing a broad clinical development program for setmelanotide in other rare diseases, as well as investigational MC4R agonists bivamelagon and RM-718, and a preclinical suite of small molecules for the treatment of congenital hyperinsulinism. Rhythm’s headquarters is in Boston, MA.

Setmelanotide Indication
In the United States, setmelanotide is indicated to reduce excess body weight and maintain weight reduction long term in adults and pediatric patients aged 4 years and older with acquired hypothalamic obesity, in adult and pediatric patients aged 2 years and older with syndromic or monogenic obesity due to Bardet-Biedl syndrome (BBS) or Pro-opiomelanocortin (POMC), proprotein convertase subtilisin/kexin type 1 (PCSK1), or leptin receptor (LEPR) deficiency confirmed by genetic testing demonstrating variants in POMC, PCSK1, or LEPR genes that are interpreted as pathogenic, likely pathogenic, or of uncertain significance (VUS).

In the European Union and the United Kingdom, setmelanotide is indicated for the treatment of obesity and the control of hunger associated with genetically confirmed BBS or loss-of-function biallelic POMC, including PCSK1, deficiency or biallelic LEPR deficiency in adults and children 2 years of age and above. In the European Union and the United Kingdom, setmelanotide should be prescribed and supervised by a physician with expertise in obesity with underlying genetic etiology.

Limitations of Use
Setmelanotide is not indicated for the treatment of patients with the following conditions as setmelanotide would not be expected to be effective:

  • Obesity due to suspected POMC, PCSK1, or LEPR deficiency with POMC, PCSK1, or LEPR variants classified as benign or likely benign
  • Other types of obesity not related to acquired HO, BBS, or POMC, PCSK1 or LEPR deficiency, including obesity associated with other genetic syndromes and general (polygenic) obesity.

Important Safety Information

CONTRAINDICATIONS
Prior serious hypersensitivity to setmelanotide or any of the excipients in IMCIVREE. Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported.

WARNINGS AND PRECAUTIONS

Disturbance in Sexual Arousal: Spontaneous penile erections and increased frequency of penile erections in males have occurred. Inform patients that these events may occur and instruct patients who have an erection lasting longer than 4 hours to seek emergency medical attention.

Depression and Suicidal Ideation: Depression and suicidal ideation have occurred. Monitor patients for new onset or worsening depression or suicidal thoughts or behaviors. Consider discontinuing IMCIVREE if patients experience suicidal thoughts or behaviors, or clinically significant or persistent depression symptoms occur.

Hypersensitivity Reactions: Serious hypersensitivity reactions (e.g., anaphylaxis) have been reported. If suspected, advise patients to promptly seek medical attention and discontinue IMCIVREE.

Skin Hyperpigmentation, Darkening of Pre-existing Nevi, and Development of New Melanocytic Nevi: Generalized or focal increases in skin pigmentation occurred in the majority of IMCIVREE-treated patients. IMCIVREE may also cause development of new melanocytic nevi or darkening of pre-existing nevi. Perform a full body skin examination prior to initiation and periodically during treatment to monitor pre-existing and new pigmented lesions.

Acute Adrenal Insufficiency with Acquired HO: Patients with acquired HO and secondary adrenal insufficiency reported serious adverse reactions related to acute adrenal insufficiency in 5% of IMCIVREE-treated patients and no placebo-treated patients. In patients with secondary adrenal insufficiency, monitor for clinical signs of acute adrenal insufficiency.

Sodium Imbalance in Patients with Acquired HO and Central Diabetes Insipidus: Patients with acquired HO and concomitant central diabetes insipidus (DI)/arginine vasopressin (AVP) deficiency reported hyponatremia in 6% of IMCIVREE-treated patients and 2% of placebo-treated patients and hypernatremia in 5% of IMCIVREE-treated patients and 4% of placebo-treated patients. Monitor serum sodium levels with changes in fluid intake and hydration status. Adjust the doses of concomitant therapies for DI/AVP deficiency as needed.

ADVERSE REACTIONS
Most common adverse reactions (incidence ≥20% in at least 1 indication) included skin hyperpigmentation, injection site reactions, nausea, headache, diarrhea, abdominal pain, vomiting, depression, and spontaneous penile erection.

USE IN SPECIFIC POPULATIONS
Treatment with IMCIVREE is not recommended when breastfeeding. Discontinue IMCIVREE when pregnancy is recognized unless the benefits of therapy outweigh the potential risks to the fetus.

To report SUSPECTED ADVERSE REACTIONS, contact Rhythm Pharmaceuticals at +1 (833) 789-6337 or FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. See section 4.8 of the Summary of Product Characteristics for information on reporting suspected adverse reactions in Europe.

Please see the full Prescribing Information for additional Important Safety Information.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including without limitation statements regarding the safety, efficacy, potential benefits of, and clinical design or progress of any of our products or product candidates at any dosage or in any indication; the approval and use of IMCIVREE in patients with acquired hypothalamic obesity and its availability for patients; the commercial growth of IMCIVREE; our expectations surrounding potential regulatory submissions, progress, or approvals and timing thereof for any of our product candidates; the estimated market size and addressable population for our drug products, including IMCIVREE for the treatment of hypothalamic obesity in the United States, the European Union and Japan; the future announcement of data from our ongoing clinical trials; the ongoing enrollment in and potential progress or outcomes of our clinical trials; the presentation of the full data from the TRANSCEND study at an upcoming medical meeting; and the content, date and timing of any of the foregoing. Statements using words such as “expect”, “anticipate”, “believe”, “may”, “will” and similar terms are also forward-looking statements. Such statements are subject to numerous risks and uncertainties, including, but not limited to, our ability to enroll patients in clinical trials, the design and outcome of clinical trials, the impact of competition, the ability to achieve or obtain necessary regulatory approvals, risks associated with data analysis and reporting, unfavorable pricing regulations, third-party reimbursement practices or healthcare reform initiatives, risks associated with the laws and regulations governing our international operations and the costs of any related compliance programs, our ability to successfully commercialize setmelanotide, our liquidity and expenses, our ability to retain our key employees and consultants, and to attract, retain and motivate qualified personnel, and general economic conditions, and the other important factors, including those discussed under the caption “Risk Factors” in Rhythm’s Annual Report on Form 10-K for the year ended December 31, 2025 and our other filings with the Securities and Exchange Commission. Except as required by law, we undertake no obligations to make any revisions to the forward-looking statements contained in this press release or to update them to reflect events or circumstances occurring after the date of this press release, whether as a result of new information, future developments or otherwise.

Corporate Contact:
David Connolly
Head of Investor Relations and Corporate Communications
Rhythm Pharmaceuticals, Inc.
dconnolly@rhythmtx.com

Media Contact:
Layne Cosgrove
Real Chemistry
llitsinger@realchemistry.com

Photos accompanying this announcement are available at: 

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BioSyent Releases Financial Results for Fourth Quarter and Full Year 2025

BioSyent Releases Financial Results for Fourth Quarter and Full Year 2025




BioSyent Releases Financial Results for Fourth Quarter and Full Year 2025

MISSISSAUGA, Ontario, March 19, 2026 (GLOBE NEWSWIRE) — BioSyent Inc. (“BioSyent”, TSX Venture: RX) released today its financial results for the fourth quarter (Q4) and full year (FY) ended December 31, 2025. Key highlights include:

(CAD) Q4 2025   % Change
vs.
Q4 2024
  FY 2025   % Change
vs.

FY 2024
 
Canadian Pharma Sales 8,792,653   +3 % 37,143,783   +13 %
International Pharma Sales 601,387   +240 % 3,735,959   +302 %
Legacy Business Sales 277,883   +278 % 2,172,241   +86 %
Total Company Sales 9,671,923   +10 % 43,051,983   +23 %
EBITDA1 2,528,561   +13 % 12,122,756   +30 %
Net Income After Taxes (NIAT) 1,991,788   +23 % 9,012,232   +24 %
Fully Diluted EPS 0.17   +25 % 0.78   +27 %

  • Return on Average Equity for FY 2025 was 24% as compared to 21% for FY 2024
  • During FY 2025, repurchased for cancellation a total of 19,500 common shares under a Normal Course Issuer Bid (NCIB)
  • Paid quarterly cash dividends of $0.05 per common share on March 14, 2025, June 13, 2025, September 15, 2025, and December 15, 2025
  • Increased quarterly dividend by 10% to $0.055 per common share – paid on March 13, 2026
  • Generated $2.4 million in sales in 2025 from international Tibelia® (tibolone) assets acquired in 2024
  • Completed acquisition of Oral Science Inc., a Canadian owner and distributor of specialized dental hygiene and oral health products, as announced on March 2, 2026

“We finished 2025 with double-digit overall revenue growth in the fourth quarter with continued growth in our Canadian pharmaceutical business and sizable contributions from our international Tibelia® business and legacy business,” commented Mr. René Goehrum, President and CEO of BioSyent. “For the full year, we are proud to have delivered 23% total Company revenue growth while maintaining a healthy 21% NIAT margin. We continue to invest in our FeraMAX® and Tibella® / Tibelia® products which were significant drivers of revenue and profit growth both in Canada and internationally during the year. We also continued to invest in our growing Inofolic® launch product during the year. Our mature brands, Cathejell®, RepaGyn® and Protect-It® continued to deliver profit and cash flows with narrow ongoing investment. BioSyent’s track record of 62 consecutive profitable quarters and capital-light, cash-flowing business model have enabled us to build a strong balance sheet and afforded us with maximum flexibility in capital allocation decisions. We are pleased to have deployed our hard-earned capital in our recent acquisition of Oral Science Inc. and we are eager to continue to grow this newly-acquired oral health business along with our pharmaceutical business. We will continue to invest in growth and product diversification in both of these businesses while returning capital to shareholders through share buybacks and regular cash dividends. I look forward to sharing our progress throughout 2026.”

The CEO’s presentation on the Q4 and FY 2025 Results is available at the following link: www.biosyent.com/investors/

The Company’s Audited Consolidated Financial Statements and Management’s Discussion and Analysis for the fourth quarter and full year ended December 31, 2025 and 2024 will be posted on www.sedarplus.ca on March 19, 2026.

For a direct market quote for the TSX Venture Exchange and other Company financial information, please visit www.tmxmoney.com.

About BioSyent Inc.

Listed on the TSX Venture Exchange under the trading symbol “RX”, BioSyent is a profitable growth-oriented specialty healthcare company focused on acquiring or in-licensing, marketing and distributing innovative pharmaceutical and oral health products that have been successfully developed, are safe and effective, and have a proven track record of improving the lives of patients. BioSyent supports the healthcare professionals that treat these patients by marketing its products through its Canadian pharma, international pharma, and oral health business units.

As of the date of this press release, the Company has 11,497,447 common shares outstanding.

 
BioSyent Inc.
Consolidated Statements of Comprehensive Income
             
In Canadian Dollars Q4 2025   Q4 2024   % Change   FY 2025   FY 2024   % Change  
Net Revenues 9,671,923   8,796,684   10 % 43,051,983   35,030,897   23 %
Cost of Goods Sold 2,225,569   1,641,735   36 % 10,088,955   7,174,824   41 %
Gross Profit 7,446,354   7,154,949   4 % 32,963,028   27,856,073   18 %
Operating Expenses and Finance Income/Costs 4,967,966   4,904,040   1 % 20,933,016   18,073,575   16 %
Net Income Before Tax 2,478,388   2,250,909   10 % 12,030,012   9,782,498   23 %
Tax (including Deferred Tax) 486,600   637,715   -24 % 3,017,780   2,512,394   20 %
Net Income After Tax 1,991,788   1,613,194   23 % 9,012,232   7,270,104   24 %
Net Income After Tax % to Net Revenues 21 % 18 %   21 % 21 %  
EBITDA1 2,528,561   2,241,112   13 % 12,122,756   9,343,012   30 %
EBITDA1 % to Net Revenues 26 % 25 %   28 % 27 %  

 
BioSyent Inc.
Consolidated Statements of Financial Position
       
AS AT   December 31, 2025 December 31, 2024 % Change
ASSETS      
       
Cash, cash equivalents and short-term investments $ 28,651,823 $ 15,940,971 80 %
Trade and other receivables   4,456,562   2,906,829 53 %
Inventory   6,416,204   5,328,086 20 %
Prepaid expenses and deposits   187,977   201,971 -7 %
Derivative asset     5,790 -100 %
Loans receivable – current   80,395   87,433 -8 %
CURRENT ASSETS   39,792,961   24,471,080 63 %
       
Long term investments   3,293,957   10,103,571 -67 %
Loans receivable – current   61,799   141,140 -56 %
Deferred tax asset   510,932   401,166 27 %
Property and equipment   982,737   1,200,992 -18 %
Intangible assets   4,797,073   5,041,501 -5 %
TOTAL NON CURRENT ASSETS   9,646,498   16,888,370 -43 %
TOTAL ASSETS $ 49,439,459 $ 41,359,450 20 %
       
LIABILITIES AND SHAREHOLDERS’ EQUITY      
       
CURRENT LIABILITIES $ 7,215,608 $ 5,405,106 33 %
NON CURRENT LIABILITIES   758,345   951,159 -20 %
Long term debt     0 %
Total Equity   41,465,506   35,003,185 18 %
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $ 49,439,459 $ 41,359,450 20 %
             
  1. EBITDA is a Non-IFRS Financial Measure. The term EBITDA does not have any standardized meaning under International Financial Reporting Standards (IFRS) and therefore may not be comparable to similar measures presented by other companies. The Company defines EBITDA as earnings before interest income or expense, income taxes, depreciation and amortization.

A reconciliation of EBITDA to NIAT for the three months, twelve months, and trailing twelve months ended December 31, 2025 and 2024 is provided in the table below:

    Three Months (Q4)
Ended December 31
  Full Year (FY)
Ended December 31
 
    2025   2024   2025   2024  
EBITDA 2,528,561   2,241,112   12,122,756   9,343,012  
Add: Interest Income 187,767   260,088   809,100   1,088,586  
Less: Depreciation – Property, Equipment (70,964 ) (72,113 ) (272,299 ) (281,220 )
  Amortization of Intangible Assets (155,498 ) (164,207 ) (580,192 ) (308,728 )
  Interest Expense (11,478 ) (13,971 ) (49,353 ) (59,152 )
  Income Tax Expense (486,600 ) (637,715 ) (3,017,780 ) (2,512,394 )
NIAT 1,991,788   1,613,194   9,012,232   7,270,104  
                   

For further information please contact:
Mr. René C. Goehrum
President and CEO
BioSyent Inc.
E-Mail: investors@biosyent.com
Phone: 905-206-0013
Web: www.biosyent.com

This press release may contain information or statements that are forward-looking. The contents herein represent our judgment, as at the release date, and are subject to risks and uncertainties that may cause actual results or outcomes to be materially different from the forward-looking information or statements. Potential risks may include, but are not limited to, those associated with clinical trials, product development, future revenue, operations, profitability and obtaining regulatory approvals. Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this press release.

Cosmos Health Provides Update; Evaluates Options to Address Valuation Disconnect; Will Issue Updated Guidance Following FY 2025 Results; Record Growth Continues as Significant U.S. Expansion Underway, with Additional $12M+ in High-Margin Revenue Projected; Important R&D Updates Expected Following Finalization of Certain Anticipated Transactions

Cosmos Health Provides Update; Evaluates Options to Address Valuation Disconnect; Will Issue Updated Guidance Following FY 2025 Results; Record Growth Continues as Significant U.S. Expansion Underway, with Additional $12M+ in High-Margin Revenue Projected; Important R&D Updates Expected Following Finalization of Certain Anticipated Transactions




Cosmos Health Provides Update; Evaluates Options to Address Valuation Disconnect; Will Issue Updated Guidance Following FY 2025 Results; Record Growth Continues as Significant U.S. Expansion Underway, with Additional $12M+ in High-Margin Revenue Projected; Important R&D Updates Expected Following Finalization of Certain Anticipated Transactions

  • Continues to deliver record revenue and improving operating metrics
  • Significant expansion in the United States underway, with NOOR and other Sky Premium Life products expected to drive strong profitability
    • supported by gross margins of approximately 75%
    • NOOR Collagen alone is projected to generate more than $12 million in annualized revenue
  • Strong growth expected ahead, driven by organic progress and M&A pipeline
    • including a recent LOI to acquire an $11.5 million pharmacy distribution network
  • Holds valuable non-core strategic real estate and digital assets with an estimated fair market value exceeding $18 million, providing meaningful balance sheet flexibility
  • Evaluating potential monetization of non-core assets to
    • support more efficient capital allocation
    • accelerate strategic investments
    • address the current valuation disconnect, including options such as share repurchases
  • Recent geopolitical turmoil has had a negligible impact on the Company’s operations, with record-breaking growth continuing at a strong pace
  • To issue guidance update following the release of fourth quarter and full-year 2025 results
  • Analyst coverage initiated by Zacks Small-Cap Research with a valuation of $4.50 per share

CHICAGO, March 19, 2026 (GLOBE NEWSWIRE) — Cosmos Health Inc. (“Cosmos Health” or the “Company”) (NASDAQ:COSM), a diversified, vertically integrated global healthcare group, today provided a corporate update and announced that it intends to issue updated operational, strategic, and financial guidance following the release of its fourth quarter and full-year 2025 financial results.

Record Operating Momentum
Cosmos Health continues to deliver record revenue and gross profit while improving operating metrics, reflecting disciplined execution across all core divisions. Management believes the Company is progressing toward sustained profitability as revenue continues to grow, scale efficiencies crystallize, and margins improve.

The war in the Middle East and recent geopolitical turmoil have had a negligible impact on the Company’s operations. The Company expects record-breaking growth to continue at a strong pace as it advances toward sustained profitability.

Strong Growth Amid Significant U.S. Expansion & Partnerships with Leading Retailers
Recent milestones include the continued global expansion of the Company’s proprietary brands. Sky Premium Life is growing across Europe and beyond. Importantly, the Company has recently entered the United States market with its NOOR and other Sky Premium Life products.

All NOOR Sky Premium Life products sold in the United States are manufactured locally in GMP-certified, FDA-registered, and UL-audited U.S. facilities, underscoring the Company’s commitment to regulatory excellence and product integrity while mitigating tariff exposure and cross-border logistical risks.

Cosmos Health anticipates strong gross margins of approximately 75% and significant cash flow generation from its Sky Premium Life U.S. operations. NOOR Collagen alone is projected to generate more than $12 million in annualized revenue, with additional growth expected as the Company introduces new products and expands its Sky Premium Life portfolio in the U.S. to meet strong consumer demand.

C-Scrub is gaining commercial validation in the United Kingdom through expanded retail presence at Tesco, the UK’s largest retailer, and Superdrug, the UK’s second-largest beauty and health retailer.

The Company’s contract manufacturing division continues to expand through new long-term agreements, while its wholesale logistics operations are serving increasing volumes across a growing pharmacy network.

R&D at the Forefront of Innovation
Cosmos Health continues to advance its R&D pipeline, further strengthened by the recent appointment of Dr. Dimitrios Iliopoulos, a globally recognized expert in AI-driven drug discovery and clinical-stage biotechnology, to its Advisory Board.

The Company expects to provide updates regarding significant progress across several R&D initiatives following the finalization of certain anticipated transactions.

M&A Pipeline
On March 6, 2026, Cosmos Health entered into a Letter of Intent to acquire an extensive pharmacy distribution network from an established pharmaceutical company serving the Greek market for almost 40 years. The network currently generates approximately $11.5 million in annual gross revenue and serves a broad base of pharmacy customers, supplying both pharmaceutical and para-pharmaceutical products.

In addition, the Company is actively evaluating a robust pipeline of acquisition opportunities designed to expand its distribution footprint, enhance operating scale, and drive profitability.

Balance Sheet Flexibility: $18 Million in Non-Core Assets
In addition to its core healthcare operating segments, the Company holds valuable non-core strategic assets that provide meaningful balance sheet flexibility. Among others, the Company owns real estate assets with an estimated fair market value of approximately $15 million and has also deployed $3.1 million into digital assets under its treasury strategy.

Zacks Coverage Initiated with $4.50 Per Share Valuation
Zacks Small-Cap Research initiated coverage on the Company with a valuation of $4.50 per share, according to a research report published on January 13, 2026. The report highlights Cosmos Health’s diversified revenue base, vertically integrated pharmaceutical and manufacturing operations, technology-driven initiatives, expansion into the U.S. market, and improving financial performance as key factors supporting its valuation.

Capital Allocation Considerations Amid Valuation Disconnect
At current trading levels, the Company’s shares trade at a significant discount to reported book value (stockholders’ equity), and management believes the Company’s market capitalization does not fully reflect the intrinsic value of its diversified asset base and strong operating performance.

While management recognizes the long-term strategic value of its real estate and digital asset holdings, it is also evaluating potential monetization options, subject to market conditions, that could generate substantial capital to address the current valuation disconnect and support key corporate priorities, including acquisitions, technology investments, debt reduction, and returning capital to shareholders, including share repurchases.

Greg Siokas, CEO of Cosmos Health, stated: “Our operating performance remains strong, with record revenue, improving profitability metrics, and an important expansion in the United States already underway with local manufacturing capabilities. At the same time, our balance sheet provides meaningful flexibility through a diversified asset base that includes non-core assets such as wholly owned real estate and digital holdings with a collective fair market value potentially exceeding $18 million. This represents a significant amount relative to our current market capitalization.

To provide greater visibility and a clear roadmap for investors, we intend to issue updated guidance on our operational, strategic, and financial outlook following our FY 2025 results and outline the next phase of our strategic priorities designed to enhance long-term shareholder value. Given current valuation levels, we are also evaluating capital allocation alternatives, including share repurchases.”

About Cosmos Health Inc.

Cosmos Health Inc. (Nasdaq:COSM), incorporated in 2009 in Nevada, is a diversified, vertically integrated global healthcare group. The Company owns a portfolio of proprietary pharmaceutical and nutraceutical brands, including Sky Premium Life®, Mediterranation®, bio-bebe®, C-Sept® and C-Scrub®. Through its subsidiary Cana Laboratories S.A., licensed under European Good Manufacturing Practices (GMP) and certified by the European Medicines Agency (EMA), it manufactures pharmaceuticals, food supplements, cosmetics, biocides, and medical devices within the European Union. Cosmos Health also distributes a broad line of pharmaceuticals and parapharmaceuticals, including branded generics and OTC medications, to retail pharmacies and wholesale distributors through its subsidiaries in Greece and the UK. Furthermore, the Company has established R&D partnerships targeting major health disorders such as obesity, diabetes, and cancer, enhanced by artificial intelligence drug repurposing technologies, and focuses on the R&D of novel patented nutraceuticals, specialized root extracts, proprietary complex generics, and innovative OTC products. Cosmos Health has also entered the telehealth space through the acquisition of ZipDoctor, Inc., based in Texas, USA. With a global distribution platform, the Company is currently expanding throughout Europe, Asia, and North America, and has offices and distribution centers in Thessaloniki and Athens, Greece, and in Harlow, UK. More information is available at www.cosmoshealthinc.com, www.skypremiumlife.com, www.cana.gr, www.zipdoctor.co, www.cloudscreen.gr, as well as LinkedIn and X.

Forward-Looking Statements
With the exception of the historical information contained in this news release, the matters described herein may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Words such as “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans,” and similar expressions, or future or conditional verbs such as “will,” “should,” “would,” “may,” and “could,” generally identify forward-looking statements, although not all forward-looking statements contain these words. These statements involve risks and uncertainties that may individually or materially affect the matters discussed herein for a variety of reasons outside the Company’s control, including, but not limited to: the Company’s ability to raise sufficient financing to implement its business plan; the effectiveness of its digital asset strategies, including accumulation and yield-generating activities; the impact of the war in Ukraine on the Company’s business, operations, and the economy in general; and the Company’s ability to successfully develop and commercialize its proprietary products and technologies. Readers are cautioned not to place undue reliance on these forward-looking statements, as actual results could differ materially from those anticipated. Readers are encouraged to review the risk factors set forth in the Company’s filings with the SEC, which are available at the SEC’s website (www.sec.gov). The Company disclaims any obligation to update or revise forward-looking statements, whether as a result of any new information, future events, or otherwise.

Investor Relations Contact:
BDG Communications
cosm@bdgcommunications.com

New partnership to fast-track Canadian health technology from innovation to patient care

New partnership to fast-track Canadian health technology from innovation to patient care




New partnership to fast-track Canadian health technology from innovation to patient care

AIM Institute and CAN Health Network join forces to help 
Canadian solutions reach clinicians and patients faster

NEW WESTMINSTER, British Columbia, March 19, 2026 (GLOBE NEWSWIRE) — Royal Columbian Hospital Foundation’s AIM Institute (Advancing Innovation in Medicine) has partnered with the CAN Health Network to collaborate in supporting and scaling promising Canadian health technologies – helping patients benefit sooner from made-in-Canada solutions.

This collaboration brings together two Canadian organizations with a shared commitment to strengthening patient care through innovation. By aligning AIM’s clinical expertise and trial infrastructure with the CAN Health Network’s national network of health care operators and procurement pathways, the partnership is designed to help Canadian health-tech companies move faster from idea to validated solution, and ultimately to broader adoption across Canada.

Canadian health-tech companies will benefit from access to user-defined clinical challenges, direct engagement with frontline clinicians, rigorous clinical trial design and execution, and real-world product evaluation. The goal is to ensure that new solutions are not only innovative, but also clinically validated, economically viable, and ready for scale within Canada’s health care system.

As a social enterprise of Royal Columbian Hospital Foundation, AIM Institute partners with health-tech innovators at every stage of development, from early clinical guidance to multi-centre trials and real-world implementation. Its work is grounded in the belief that improving patient care and achieving commercial success are intrinsically linked.

The CAN Health Network connects healthcare organizations across the country through an integrated market to identify challenges, validate Canadian solutions in real-world settings, and support procurement and scale. Since its launch in 2019, CAN Health has supported commercialization projects with more than 100 Canadian companies, helping strengthen health care delivery while driving economic growth.

“Working alongside the CAN Health Network allows us to help promising Canadian technologies move more efficiently from concept to real-world use,” says Dr. Steve Reynolds, Royal Columbian Hospital ICU physician and AIM Executive Lead. “This helps ensure that solutions developed here can ultimately improve care for patients and support healthcare teams across the country and beyond.”

“The most powerful health care solutions come from solving real problems faced by patients and providers,” said Dante Morra, Founder & CEO, CAN Health Network. “By connecting innovators with frontline health care environments through the AIM Institute, we can test, validate and scale Canadian solutions faster, improving care while helping Canadian companies grow and succeed.”

This partnership between AIM and CAN Health establishes a framework for the two organizations to identify opportunities, align clinical and operational expertise, and accelerate the evaluation and adoption of innovative technologies.

By connecting clinical insight, rigorous evaluation, and national pathways for adoption, the partnership aims to strengthen Canada’s health innovation ecosystem while ensuring that patients, providers and the broader economy benefit.

About Royal Columbian Hospital

As BC’s most comprehensive critical care hospital, one in three British Columbians rely on Royal Columbian Hospital. We are the only hospital in BC with trauma, cardiac, neurosciences, high-risk obstetrics and neonatal intensive care on one site. We look after some of the most seriously ill and injured patients, and we do it with the support of donors like you.

Since 1978, donors to Royal Columbian Hospital Foundation have helped fund priority equipment needs, facility enhancements, research, education and innovation at Royal Columbian Hospital. Visit rchfoundation.com for more information.

As part of Royal Columbian Hospital Foundation, the AIM Institute is a social enterprise that partners with innovative health-tech companies, providing clinical insights grounded in deep expertise, alongside clinical trial design and execution.

About the CAN Health Network

The Coordinated Accessible National (CAN) Health Network is a federally supported, not-for-profit organization that works with health care operators across Canada to identify challenges, validate Canadian innovations in real-world settings, and support procurement and scale. Since its launch in 2019, CAN Health has supported commercialization projects with more than 100 Canadian companies, helping strengthen health care delivery while driving economic growth.

CONTACT: For more information, please contact:
Jason Howe
Vice President, Marketing and Communications
C: 236.332.0798
Jason.Howe@fraserhealth.ca

Jennifer Coulman
Manager, Communications
CAN Health Network
jennifer.coulman@canhealthnetwork.ca

Cosmos Health Provides Update; Evaluates Options to Address Valuation Disconnect; Will Issue Updated Guidance Following FY 2025 Results; Record Growth Continues as Significant U.S. Expansion Underway, with Additional $12M+ in High-Margin Revenue Projected; Important R&D Updates Expected Following Finalization of Certain Anticipated Transactions

Cosmos Health Provides Update; Evaluates Options to Address Valuation Disconnect; Will Issue Updated Guidance Following FY 2025 Results; Record Growth Continues as Significant U.S. Expansion Underway, with Additional $12M+ in High-Margin Revenue Projected; Important R&D Updates Expected Following Finalization of Certain Anticipated Transactions




Cosmos Health Provides Update; Evaluates Options to Address Valuation Disconnect; Will Issue Updated Guidance Following FY 2025 Results; Record Growth Continues as Significant U.S. Expansion Underway, with Additional $12M+ in High-Margin Revenue Projected; Important R&D Updates Expected Following Finalization of Certain Anticipated Transactions

  • Continues to deliver record revenue and improving operating metrics
  • Significant expansion in the United States underway, with NOOR and other Sky Premium Life products expected to drive strong profitability
    • supported by gross margins of approximately 75%
    • NOOR Collagen alone is projected to generate more than $12 million in annualized revenue
  • Strong growth expected ahead, driven by organic progress and M&A pipeline
    • including a recent LOI to acquire an $11.5 million pharmacy distribution network
  • Holds valuable non-core strategic real estate and digital assets with an estimated fair market value exceeding $18 million, providing meaningful balance sheet flexibility
  • Evaluating potential monetization of non-core assets to
    • support more efficient capital allocation
    • accelerate strategic investments
    • address the current valuation disconnect, including options such as share repurchases
  • Recent geopolitical turmoil has had a negligible impact on the Company’s operations, with record-breaking growth continuing at a strong pace
  • To issue guidance update following the release of fourth quarter and full-year 2025 results
  • Analyst coverage initiated by Zacks Small-Cap Research with a valuation of $4.50 per share

CHICAGO, March 19, 2026 (GLOBE NEWSWIRE) — Cosmos Health Inc. (“Cosmos Health” or the “Company”) (NASDAQ:COSM), a diversified, vertically integrated global healthcare group, today provided a corporate update and announced that it intends to issue updated operational, strategic, and financial guidance following the release of its fourth quarter and full-year 2025 financial results.

Record Operating Momentum
Cosmos Health continues to deliver record revenue and gross profit while improving operating metrics, reflecting disciplined execution across all core divisions. Management believes the Company is progressing toward sustained profitability as revenue continues to grow, scale efficiencies crystallize, and margins improve.

The war in the Middle East and recent geopolitical turmoil have had a negligible impact on the Company’s operations. The Company expects record-breaking growth to continue at a strong pace as it advances toward sustained profitability.

Strong Growth Amid Significant U.S. Expansion & Partnerships with Leading Retailers
Recent milestones include the continued global expansion of the Company’s proprietary brands. Sky Premium Life is growing across Europe and beyond. Importantly, the Company has recently entered the United States market with its NOOR and other Sky Premium Life products.

All NOOR Sky Premium Life products sold in the United States are manufactured locally in GMP-certified, FDA-registered, and UL-audited U.S. facilities, underscoring the Company’s commitment to regulatory excellence and product integrity while mitigating tariff exposure and cross-border logistical risks.

Cosmos Health anticipates strong gross margins of approximately 75% and significant cash flow generation from its Sky Premium Life U.S. operations. NOOR Collagen alone is projected to generate more than $12 million in annualized revenue, with additional growth expected as the Company introduces new products and expands its Sky Premium Life portfolio in the U.S. to meet strong consumer demand.

C-Scrub is gaining commercial validation in the United Kingdom through expanded retail presence at Tesco, the UK’s largest retailer, and Superdrug, the UK’s second-largest beauty and health retailer.

The Company’s contract manufacturing division continues to expand through new long-term agreements, while its wholesale logistics operations are serving increasing volumes across a growing pharmacy network.

R&D at the Forefront of Innovation
Cosmos Health continues to advance its R&D pipeline, further strengthened by the recent appointment of Dr. Dimitrios Iliopoulos, a globally recognized expert in AI-driven drug discovery and clinical-stage biotechnology, to its Advisory Board.

The Company expects to provide updates regarding significant progress across several R&D initiatives following the finalization of certain anticipated transactions.

M&A Pipeline
On March 6, 2026, Cosmos Health entered into a Letter of Intent to acquire an extensive pharmacy distribution network from an established pharmaceutical company serving the Greek market for almost 40 years. The network currently generates approximately $11.5 million in annual gross revenue and serves a broad base of pharmacy customers, supplying both pharmaceutical and para-pharmaceutical products.

In addition, the Company is actively evaluating a robust pipeline of acquisition opportunities designed to expand its distribution footprint, enhance operating scale, and drive profitability.

Balance Sheet Flexibility: $18 Million in Non-Core Assets
In addition to its core healthcare operating segments, the Company holds valuable non-core strategic assets that provide meaningful balance sheet flexibility. Among others, the Company owns real estate assets with an estimated fair market value of approximately $15 million and has also deployed $3.1 million into digital assets under its treasury strategy.

Zacks Coverage Initiated with $4.50 Per Share Valuation
Zacks Small-Cap Research initiated coverage on the Company with a valuation of $4.50 per share, according to a research report published on January 13, 2026. The report highlights Cosmos Health’s diversified revenue base, vertically integrated pharmaceutical and manufacturing operations, technology-driven initiatives, expansion into the U.S. market, and improving financial performance as key factors supporting its valuation.

Capital Allocation Considerations Amid Valuation Disconnect
At current trading levels, the Company’s shares trade at a significant discount to reported book value (stockholders’ equity), and management believes the Company’s market capitalization does not fully reflect the intrinsic value of its diversified asset base and strong operating performance.

While management recognizes the long-term strategic value of its real estate and digital asset holdings, it is also evaluating potential monetization options, subject to market conditions, that could generate substantial capital to address the current valuation disconnect and support key corporate priorities, including acquisitions, technology investments, debt reduction, and returning capital to shareholders, including share repurchases.

Greg Siokas, CEO of Cosmos Health, stated: “Our operating performance remains strong, with record revenue, improving profitability metrics, and an important expansion in the United States already underway with local manufacturing capabilities. At the same time, our balance sheet provides meaningful flexibility through a diversified asset base that includes non-core assets such as wholly owned real estate and digital holdings with a collective fair market value potentially exceeding $18 million. This represents a significant amount relative to our current market capitalization.

To provide greater visibility and a clear roadmap for investors, we intend to issue updated guidance on our operational, strategic, and financial outlook following our FY 2025 results and outline the next phase of our strategic priorities designed to enhance long-term shareholder value. Given current valuation levels, we are also evaluating capital allocation alternatives, including share repurchases.”

About Cosmos Health Inc.

Cosmos Health Inc. (Nasdaq:COSM), incorporated in 2009 in Nevada, is a diversified, vertically integrated global healthcare group. The Company owns a portfolio of proprietary pharmaceutical and nutraceutical brands, including Sky Premium Life®, Mediterranation®, bio-bebe®, C-Sept® and C-Scrub®. Through its subsidiary Cana Laboratories S.A., licensed under European Good Manufacturing Practices (GMP) and certified by the European Medicines Agency (EMA), it manufactures pharmaceuticals, food supplements, cosmetics, biocides, and medical devices within the European Union. Cosmos Health also distributes a broad line of pharmaceuticals and parapharmaceuticals, including branded generics and OTC medications, to retail pharmacies and wholesale distributors through its subsidiaries in Greece and the UK. Furthermore, the Company has established R&D partnerships targeting major health disorders such as obesity, diabetes, and cancer, enhanced by artificial intelligence drug repurposing technologies, and focuses on the R&D of novel patented nutraceuticals, specialized root extracts, proprietary complex generics, and innovative OTC products. Cosmos Health has also entered the telehealth space through the acquisition of ZipDoctor, Inc., based in Texas, USA. With a global distribution platform, the Company is currently expanding throughout Europe, Asia, and North America, and has offices and distribution centers in Thessaloniki and Athens, Greece, and in Harlow, UK. More information is available at www.cosmoshealthinc.com, www.skypremiumlife.com, www.cana.gr, www.zipdoctor.co, www.cloudscreen.gr, as well as LinkedIn and X.

Forward-Looking Statements
With the exception of the historical information contained in this news release, the matters described herein may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Words such as “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans,” and similar expressions, or future or conditional verbs such as “will,” “should,” “would,” “may,” and “could,” generally identify forward-looking statements, although not all forward-looking statements contain these words. These statements involve risks and uncertainties that may individually or materially affect the matters discussed herein for a variety of reasons outside the Company’s control, including, but not limited to: the Company’s ability to raise sufficient financing to implement its business plan; the effectiveness of its digital asset strategies, including accumulation and yield-generating activities; the impact of the war in Ukraine on the Company’s business, operations, and the economy in general; and the Company’s ability to successfully develop and commercialize its proprietary products and technologies. Readers are cautioned not to place undue reliance on these forward-looking statements, as actual results could differ materially from those anticipated. Readers are encouraged to review the risk factors set forth in the Company’s filings with the SEC, which are available at the SEC’s website (www.sec.gov). The Company disclaims any obligation to update or revise forward-looking statements, whether as a result of any new information, future events, or otherwise.

Investor Relations Contact:
BDG Communications
cosm@bdgcommunications.com

New partnership to fast-track Canadian health technology from innovation to patient care

New partnership to fast-track Canadian health technology from innovation to patient care




New partnership to fast-track Canadian health technology from innovation to patient care

AIM Institute and CAN Health Network join forces to help 
Canadian solutions reach clinicians and patients faster

NEW WESTMINSTER, British Columbia, March 19, 2026 (GLOBE NEWSWIRE) — Royal Columbian Hospital Foundation’s AIM Institute (Advancing Innovation in Medicine) has partnered with the CAN Health Network to collaborate in supporting and scaling promising Canadian health technologies – helping patients benefit sooner from made-in-Canada solutions.

This collaboration brings together two Canadian organizations with a shared commitment to strengthening patient care through innovation. By aligning AIM’s clinical expertise and trial infrastructure with the CAN Health Network’s national network of health care operators and procurement pathways, the partnership is designed to help Canadian health-tech companies move faster from idea to validated solution, and ultimately to broader adoption across Canada.

Canadian health-tech companies will benefit from access to user-defined clinical challenges, direct engagement with frontline clinicians, rigorous clinical trial design and execution, and real-world product evaluation. The goal is to ensure that new solutions are not only innovative, but also clinically validated, economically viable, and ready for scale within Canada’s health care system.

As a social enterprise of Royal Columbian Hospital Foundation, AIM Institute partners with health-tech innovators at every stage of development, from early clinical guidance to multi-centre trials and real-world implementation. Its work is grounded in the belief that improving patient care and achieving commercial success are intrinsically linked.

The CAN Health Network connects healthcare organizations across the country through an integrated market to identify challenges, validate Canadian solutions in real-world settings, and support procurement and scale. Since its launch in 2019, CAN Health has supported commercialization projects with more than 100 Canadian companies, helping strengthen health care delivery while driving economic growth.

“Working alongside the CAN Health Network allows us to help promising Canadian technologies move more efficiently from concept to real-world use,” says Dr. Steve Reynolds, Royal Columbian Hospital ICU physician and AIM Executive Lead. “This helps ensure that solutions developed here can ultimately improve care for patients and support healthcare teams across the country and beyond.”

“The most powerful health care solutions come from solving real problems faced by patients and providers,” said Dante Morra, Founder & CEO, CAN Health Network. “By connecting innovators with frontline health care environments through the AIM Institute, we can test, validate and scale Canadian solutions faster, improving care while helping Canadian companies grow and succeed.”

This partnership between AIM and CAN Health establishes a framework for the two organizations to identify opportunities, align clinical and operational expertise, and accelerate the evaluation and adoption of innovative technologies.

By connecting clinical insight, rigorous evaluation, and national pathways for adoption, the partnership aims to strengthen Canada’s health innovation ecosystem while ensuring that patients, providers and the broader economy benefit.

About Royal Columbian Hospital

As BC’s most comprehensive critical care hospital, one in three British Columbians rely on Royal Columbian Hospital. We are the only hospital in BC with trauma, cardiac, neurosciences, high-risk obstetrics and neonatal intensive care on one site. We look after some of the most seriously ill and injured patients, and we do it with the support of donors like you.

Since 1978, donors to Royal Columbian Hospital Foundation have helped fund priority equipment needs, facility enhancements, research, education and innovation at Royal Columbian Hospital. Visit rchfoundation.com for more information.

As part of Royal Columbian Hospital Foundation, the AIM Institute is a social enterprise that partners with innovative health-tech companies, providing clinical insights grounded in deep expertise, alongside clinical trial design and execution.

About the CAN Health Network

The Coordinated Accessible National (CAN) Health Network is a federally supported, not-for-profit organization that works with health care operators across Canada to identify challenges, validate Canadian innovations in real-world settings, and support procurement and scale. Since its launch in 2019, CAN Health has supported commercialization projects with more than 100 Canadian companies, helping strengthen health care delivery while driving economic growth.

CONTACT: For more information, please contact:
Jason Howe
Vice President, Marketing and Communications
C: 236.332.0798
Jason.Howe@fraserhealth.ca

Jennifer Coulman
Manager, Communications
CAN Health Network
jennifer.coulman@canhealthnetwork.ca

The Endothelial Glycocalyx Explained: How It Helps Regulate Vascular Function

The Endothelial Glycocalyx Explained: How It Helps Regulate Vascular Function




The Endothelial Glycocalyx Explained: How It Helps Regulate Vascular Function

  • The Endothelial Glycocalyx Is a Gel-Like Lining Inside Every Blood Vessel — and Most People Have Never Heard of It
  • Standard Cardiovascular Screenings Focus on Large Arteries but Do Not Assess What Is Happening at the Microvascular Level
  • How Published Research and Patented Lab-on-a-Chip Technology Are Advancing What We Know About Glycocalyx Function
  • Why Lifestyle Factors Like Diet, Movement, and Targeted Supplementation May Help Maintain Glycocalyx Integrity

Scottsdale, AZ, March 19, 2026 (GLOBE NEWSWIRE) — Calroy Health Sciences, a science-driven dietary supplement company focused on foundational health, has published a comprehensive educational resource exploring the role of the endothelial glycocalyx (EGX) in everyday circulation. The article, Microcirculation and Blood Flow: The Missing Link Between How You Feel Every Day and the Endothelial Glycocalyx, provides an accessible overview of the science behind a vascular structure most people have never heard of.

Dr. Joel Kahn, MD, integrative cardiologist, founder of the Kahn Center for Cardiac Longevity in Bingham Farms, Michigan, and frequent educator for Calroy, explains: “The glycocalyx is a gel-like lining inside every blood vessel. When it’s intact, blood flows the way it should. When it thins, the body feels it — even before standard tests pick anything up.”

KEY FACTS

  • The endothelial glycocalyx is a delicate, micro-thin, gel-like lining that coats the inside of every blood vessel, helping regulate vascular function throughout the body, including at the microvascular level.
  • Research published in the National Library of Medicine has identified vascular elasticity as a marker of endothelial function (PubMed: 28356037).
  • The EGX plays a functional role in supporting the movement of nutrients and oxygen from blood vessels into surrounding tissue.
  • Most routine cardiovascular screenings focus on large arteries and do not assess endothelial glycocalyx integrity or microvascular function.
  • Calroy Health Sciences utilizes patented microfluidic chip technology to simulate vascular conditions in a lab-on-a-chip environment to study endothelial glycocalyx behavior.
  • MonitumRS®, a proprietary extract of Rhamnan sulfate from Monostroma nitidum, is scientifically shown to protect and restore the endothelial glycocalyx.*†

The Endothelial Glycocalyx Is a Gel-Like Lining Inside Every Blood Vessel — and Most People Have Never Heard of It

The endothelial glycocalyx is one of the most important structures in the vascular system — and one of the least discussed. This delicate, micro-thin lining coats the interior of every blood vessel in the body, from the largest arteries to the smallest capillaries. Only recently discovered and often overlooked, it is foundational to vascular health and total-body vitality. The EGX acts as a semi-permeable barrier, facilitates smooth blood flow, and houses the enzymes involved in nitric oxide production — the molecule that helps blood vessels relax and support healthy circulation.*

When the glycocalyx is intact, blood flow at the microvascular level proceeds efficiently. Maintaining glycocalyx integrity supports efficient nutrient delivery and vascular responsiveness at the capillary level. The Calroy Health Sciences education center provides a detailed introduction to how the glycocalyx functions within the broader circulatory system.

Standard Cardiovascular Screenings Focus on Large Arteries but Do Not Assess What Is Happening at the Microvascular Level

Most cardiovascular assessments focus on large-vessel metrics — arterial imaging and standard panels that evaluate the body’s primary supply routes. These tools are valuable, but they do not evaluate what is happening at the microvascular level. The glycocalyx exists in the smallest blood vessels — the capillaries — where nutrient exchange actually occurs. This means a person can receive clear results from standard vascular screenings while their microcirculation tells a different story.

A peer-reviewed study available through the National Library of Medicine found that vascular elasticity markers can serve as early indicators of endothelial function, suggesting that tools beyond standard panels may be needed to understand full circulatory health. Calroy’s proprietary microfluidic chip technology was developed to help address this gap by simulating vascular conditions in a controlled lab-on-a-chip environment.

How Published Research and Patented Lab-on-a-Chip Technology Are Advancing What We Know About Glycocalyx Function

Calroy Health Sciences has built research around a simple question: can the glycocalyx be supported through targeted nutritional science? The company’s approach combines published peer-reviewed research with proprietary technology. Its research library includes studies on Rhamnan sulfate, nitric oxide pathways, and cartilage support.

Dr. Kahn notes: “What makes the glycocalyx conversation so important is that it connects how people feel every day — their energy, their clarity, their recovery — to a structure that science can study and support.”

The company’s Science and Medical Advisory Board includes physicians, researchers, and practitioners who guide product development and ensure claims are rooted in published science.

Why Lifestyle Factors Like Diet, Movement, and Targeted Supplementation May Help Maintain Glycocalyx Integrity

The glycocalyx is a structure to support — and lifestyle factors including diet, movement, hydration, and targeted supplementation all play a role in maintaining glycocalyx integrity. Calroy’s educational approach emphasizes that an antioxidant-dense diet, regular movement, healthy sleep routines, and mindfulness all contribute to overall wellness and vascular well-being. The company’s flagship product, Arterosil HP® with MonitumRS®, supports vascular integrity and healthy circulation.*

MonitumRS is scientifically shown to protect and restore the endothelial glycocalyx.*† Additional resources on EGX science are available at Calroy’s introduction to the endothelial glycocalyx and through practitioner-focused research on the EGX.

FREQUENTLY ASKED QUESTIONS

Why do I still feel tired even though my blood work is normal? 

Standard panels assess large-vessel markers but do not always evaluate microvascular function or glycocalyx integrity. Reduced blood flow at the capillary level — where oxygen and nutrient exchange actually happens — may affect energy and recovery even when routine screenings come back with clear results.

What is microcirculation and why does it matter? 

Microcirculation is the movement of blood through your smallest vessels — the capillaries. It’s where your body actually delivers oxygen and nutrients to tissue. Just like  large-artery circulation, microcirculation is also influenced by a structure called the endothelial glycocalyx, which most people have never heard of. A detailed overview is available at calroy.com/education/microcirculation-and-blood-flow.

What does the lining of your blood vessels actually do? 

The endothelial glycocalyx is a delicate, micro-thin, gel-like lining that coats the interior of every blood vessel. It acts as a semi-permeable barrier, facilitates smooth blood flow, and houses the enzymes involved in nitric oxide production. When the glycocalyx is compromised, circulation is affected and every organ feels the impact.

Are there tests that measure how well blood flows in small blood vessels? 

Most standard cardiovascular screenings focus on large arteries and many don’t assess microvascular function. Emerging research, including a peer-reviewed study on vascular elasticity markers (PubMed: 28356037), suggests that new tools may be needed to evaluate what’s happening at the capillary level.

Can what you eat affect your blood vessels?

Yes. Lifestyle factors including diet, hydration, movement, and healthy sleep routines can influence the integrity of the vascular system and likely the endothelial glycocalyx — the structure that lines every blood vessel and supports microcirculation. An antioxidant-rich diet and regular movement support cardiovascular and overall health.*

What supplements actually help with circulation? 

The endothelial glycocalyx is the micro-thin lining inside every blood vessel where blood flow regulation begins at the capillary level. Arterosil HP® with MonitumRS® supports vascular integrity and healthy circulation.* MonitumRS is scientifically shown to protect and restore the endothelial glycocalyx.*† 

What is the difference between arteries and capillaries? 

Arteries carry blood away from the heart through large vessels. Capillaries are the smallest vessels where the actual exchange of oxygen, nutrients, and waste occurs at the tissue level. The endothelial glycocalyx plays a key role in regulating the entire vascular system, including large arteries and tiny capillaries.


PUBLISHED RESEARCH & RESOURCES


About Calroy Health Sciences

Calroy Health Sciences is a science-driven dietary supplement company dedicated to supporting foundational health. Co-founded by CEO Ed Hoyt and Chief Scientific Officer Chen Chen, PhD, Calroy brings more than three decades of combined experience in the dietary supplement industry. The company’s breakthrough products — Arterosil HP® with MonitumRS®, Vascanox HP® with Noxa24®, and Cartigenix HP® with RestorCel™ — are developed through a research-first approach that includes studying the finished formulated product, not just individual ingredients. 

Calroy’s research has been published in peer-reviewed journals and is conducted in partnership with major academic institutions, leading clinicians and researchers. The company also holds patents on its products and its microfluidic chip testing technology. For more information, visit calroy.com.

SME Available for Commentary: Joel Kahn, MD — Integrative Cardiologist, Kahn Center for Cardiac Longevity

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

†As demonstrated in an independent third-party laboratory in vitro study.Scottsdale, AZ, March 19, 2026 (GLOBE NEWSWIRE) —

CONTACT: Sarah Evans
Partner, Head of PR, Zen Media
sarah@zenmedia.com

OKYO Pharma Announces Chairman and Founder Acquires Shares

OKYO Pharma Announces Chairman and Founder Acquires Shares




OKYO Pharma Announces Chairman and Founder Acquires Shares

LONDON and NEW YORK, March 19, 2026 (GLOBE NEWSWIRE) — OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing investigational therapies for the treatment of neuropathic corneal pain (NCP) and for inflammatory eye diseases, today announced it has been informed that Panetta Partners Limited, an entity in which Gabriele Cerrone, the Executive Chairman, has a beneficial interest, has acquired 10,119 of the Company’s ordinary shares on NASDAQ at $1.59, bringing his total holding to 10,526,416 shares.

About Urcosimod (formerly called OK-101)

Urcosimod is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response, as well as on neurons and glial cells in the dorsal root ganglion. Urcosimod has been shown to produce anti-inflammatory and pain-reducing activities in a mouse model of dry eye disease and in a neuropathic corneal pain mouse model, respectively. OKYO recently announced positive data on NCP pain reduction in a randomized, placebo-controlled, double-masked Phase 2a trial involving 18 neuropathic corneal pain subjects. Urcosimod has shown significant pain reduction in an earlier 240 subject Phase 2, multi-center, double-masked, placebo-controlled trial in DED, which supports the development rationale in NCP.

About OKYO Pharma

OKYO Pharma Limited (Nasdaq: OKYO) is a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain (NCP) and inflammatory eye diseases, with ordinary shares listed for trading on the Nasdaq Capital Market. OKYO is focused on the discovery and development of novel molecules to treat neuropathic corneal pain and other ocular diseases. OKYO recently completed a successful phase 2 trial of its flagship drug urcosimod in subjects with NCP and plans to initiate a ~150 subject Phase 2b/3 multiple-dose study of urcosimod to treat NCP in the first half of this year.

For further information, please visit www.okyopharma.com.

Inquiries:

Business Development & Investor Relations Paul Spencer +44 (0)20 7495 2379

The Endothelial Glycocalyx Explained: How It Helps Regulate Vascular Function

The Endothelial Glycocalyx Explained: How It Helps Regulate Vascular Function




The Endothelial Glycocalyx Explained: How It Helps Regulate Vascular Function

  • The Endothelial Glycocalyx Is a Gel-Like Lining Inside Every Blood Vessel — and Most People Have Never Heard of It
  • Standard Cardiovascular Screenings Focus on Large Arteries but Do Not Assess What Is Happening at the Microvascular Level
  • How Published Research and Patented Lab-on-a-Chip Technology Are Advancing What We Know About Glycocalyx Function
  • Why Lifestyle Factors Like Diet, Movement, and Targeted Supplementation May Help Maintain Glycocalyx Integrity

Scottsdale, AZ, March 19, 2026 (GLOBE NEWSWIRE) — Calroy Health Sciences, a science-driven dietary supplement company focused on foundational health, has published a comprehensive educational resource exploring the role of the endothelial glycocalyx (EGX) in everyday circulation. The article, Microcirculation and Blood Flow: The Missing Link Between How You Feel Every Day and the Endothelial Glycocalyx, provides an accessible overview of the science behind a vascular structure most people have never heard of.

Dr. Joel Kahn, MD, integrative cardiologist, founder of the Kahn Center for Cardiac Longevity in Bingham Farms, Michigan, and frequent educator for Calroy, explains: “The glycocalyx is a gel-like lining inside every blood vessel. When it’s intact, blood flows the way it should. When it thins, the body feels it — even before standard tests pick anything up.”

KEY FACTS

  • The endothelial glycocalyx is a delicate, micro-thin, gel-like lining that coats the inside of every blood vessel, helping regulate vascular function throughout the body, including at the microvascular level.
  • Research published in the National Library of Medicine has identified vascular elasticity as a marker of endothelial function (PubMed: 28356037).
  • The EGX plays a functional role in supporting the movement of nutrients and oxygen from blood vessels into surrounding tissue.
  • Most routine cardiovascular screenings focus on large arteries and do not assess endothelial glycocalyx integrity or microvascular function.
  • Calroy Health Sciences utilizes patented microfluidic chip technology to simulate vascular conditions in a lab-on-a-chip environment to study endothelial glycocalyx behavior.
  • MonitumRS®, a proprietary extract of Rhamnan sulfate from Monostroma nitidum, is scientifically shown to protect and restore the endothelial glycocalyx.*†

The Endothelial Glycocalyx Is a Gel-Like Lining Inside Every Blood Vessel — and Most People Have Never Heard of It

The endothelial glycocalyx is one of the most important structures in the vascular system — and one of the least discussed. This delicate, micro-thin lining coats the interior of every blood vessel in the body, from the largest arteries to the smallest capillaries. Only recently discovered and often overlooked, it is foundational to vascular health and total-body vitality. The EGX acts as a semi-permeable barrier, facilitates smooth blood flow, and houses the enzymes involved in nitric oxide production — the molecule that helps blood vessels relax and support healthy circulation.*

When the glycocalyx is intact, blood flow at the microvascular level proceeds efficiently. Maintaining glycocalyx integrity supports efficient nutrient delivery and vascular responsiveness at the capillary level. The Calroy Health Sciences education center provides a detailed introduction to how the glycocalyx functions within the broader circulatory system.

Standard Cardiovascular Screenings Focus on Large Arteries but Do Not Assess What Is Happening at the Microvascular Level

Most cardiovascular assessments focus on large-vessel metrics — arterial imaging and standard panels that evaluate the body’s primary supply routes. These tools are valuable, but they do not evaluate what is happening at the microvascular level. The glycocalyx exists in the smallest blood vessels — the capillaries — where nutrient exchange actually occurs. This means a person can receive clear results from standard vascular screenings while their microcirculation tells a different story.

A peer-reviewed study available through the National Library of Medicine found that vascular elasticity markers can serve as early indicators of endothelial function, suggesting that tools beyond standard panels may be needed to understand full circulatory health. Calroy’s proprietary microfluidic chip technology was developed to help address this gap by simulating vascular conditions in a controlled lab-on-a-chip environment.

How Published Research and Patented Lab-on-a-Chip Technology Are Advancing What We Know About Glycocalyx Function

Calroy Health Sciences has built research around a simple question: can the glycocalyx be supported through targeted nutritional science? The company’s approach combines published peer-reviewed research with proprietary technology. Its research library includes studies on Rhamnan sulfate, nitric oxide pathways, and cartilage support.

Dr. Kahn notes: “What makes the glycocalyx conversation so important is that it connects how people feel every day — their energy, their clarity, their recovery — to a structure that science can study and support.”

The company’s Science and Medical Advisory Board includes physicians, researchers, and practitioners who guide product development and ensure claims are rooted in published science.

Why Lifestyle Factors Like Diet, Movement, and Targeted Supplementation May Help Maintain Glycocalyx Integrity

The glycocalyx is a structure to support — and lifestyle factors including diet, movement, hydration, and targeted supplementation all play a role in maintaining glycocalyx integrity. Calroy’s educational approach emphasizes that an antioxidant-dense diet, regular movement, healthy sleep routines, and mindfulness all contribute to overall wellness and vascular well-being. The company’s flagship product, Arterosil HP® with MonitumRS®, supports vascular integrity and healthy circulation.*

MonitumRS is scientifically shown to protect and restore the endothelial glycocalyx.*† Additional resources on EGX science are available at Calroy’s introduction to the endothelial glycocalyx and through practitioner-focused research on the EGX.

FREQUENTLY ASKED QUESTIONS

Why do I still feel tired even though my blood work is normal? 

Standard panels assess large-vessel markers but do not always evaluate microvascular function or glycocalyx integrity. Reduced blood flow at the capillary level — where oxygen and nutrient exchange actually happens — may affect energy and recovery even when routine screenings come back with clear results.

What is microcirculation and why does it matter? 

Microcirculation is the movement of blood through your smallest vessels — the capillaries. It’s where your body actually delivers oxygen and nutrients to tissue. Just like  large-artery circulation, microcirculation is also influenced by a structure called the endothelial glycocalyx, which most people have never heard of. A detailed overview is available at calroy.com/education/microcirculation-and-blood-flow.

What does the lining of your blood vessels actually do? 

The endothelial glycocalyx is a delicate, micro-thin, gel-like lining that coats the interior of every blood vessel. It acts as a semi-permeable barrier, facilitates smooth blood flow, and houses the enzymes involved in nitric oxide production. When the glycocalyx is compromised, circulation is affected and every organ feels the impact.

Are there tests that measure how well blood flows in small blood vessels? 

Most standard cardiovascular screenings focus on large arteries and many don’t assess microvascular function. Emerging research, including a peer-reviewed study on vascular elasticity markers (PubMed: 28356037), suggests that new tools may be needed to evaluate what’s happening at the capillary level.

Can what you eat affect your blood vessels?

Yes. Lifestyle factors including diet, hydration, movement, and healthy sleep routines can influence the integrity of the vascular system and likely the endothelial glycocalyx — the structure that lines every blood vessel and supports microcirculation. An antioxidant-rich diet and regular movement support cardiovascular and overall health.*

What supplements actually help with circulation? 

The endothelial glycocalyx is the micro-thin lining inside every blood vessel where blood flow regulation begins at the capillary level. Arterosil HP® with MonitumRS® supports vascular integrity and healthy circulation.* MonitumRS is scientifically shown to protect and restore the endothelial glycocalyx.*† 

What is the difference between arteries and capillaries? 

Arteries carry blood away from the heart through large vessels. Capillaries are the smallest vessels where the actual exchange of oxygen, nutrients, and waste occurs at the tissue level. The endothelial glycocalyx plays a key role in regulating the entire vascular system, including large arteries and tiny capillaries.


PUBLISHED RESEARCH & RESOURCES


About Calroy Health Sciences

Calroy Health Sciences is a science-driven dietary supplement company dedicated to supporting foundational health. Co-founded by CEO Ed Hoyt and Chief Scientific Officer Chen Chen, PhD, Calroy brings more than three decades of combined experience in the dietary supplement industry. The company’s breakthrough products — Arterosil HP® with MonitumRS®, Vascanox HP® with Noxa24®, and Cartigenix HP® with RestorCel™ — are developed through a research-first approach that includes studying the finished formulated product, not just individual ingredients. 

Calroy’s research has been published in peer-reviewed journals and is conducted in partnership with major academic institutions, leading clinicians and researchers. The company also holds patents on its products and its microfluidic chip testing technology. For more information, visit calroy.com.

SME Available for Commentary: Joel Kahn, MD — Integrative Cardiologist, Kahn Center for Cardiac Longevity

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

†As demonstrated in an independent third-party laboratory in vitro study.Scottsdale, AZ, March 19, 2026 (GLOBE NEWSWIRE) —

CONTACT: Sarah Evans
Partner, Head of PR, Zen Media
sarah@zenmedia.com

OKYO Pharma Announces Chairman and Founder Acquires Shares

OKYO Pharma Announces Chairman and Founder Acquires Shares




OKYO Pharma Announces Chairman and Founder Acquires Shares

LONDON and NEW YORK, March 19, 2026 (GLOBE NEWSWIRE) — OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing investigational therapies for the treatment of neuropathic corneal pain (NCP) and for inflammatory eye diseases, today announced it has been informed that Panetta Partners Limited, an entity in which Gabriele Cerrone, the Executive Chairman, has a beneficial interest, has acquired 10,119 of the Company’s ordinary shares on NASDAQ at $1.59, bringing his total holding to 10,526,416 shares.

About Urcosimod (formerly called OK-101)

Urcosimod is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response, as well as on neurons and glial cells in the dorsal root ganglion. Urcosimod has been shown to produce anti-inflammatory and pain-reducing activities in a mouse model of dry eye disease and in a neuropathic corneal pain mouse model, respectively. OKYO recently announced positive data on NCP pain reduction in a randomized, placebo-controlled, double-masked Phase 2a trial involving 18 neuropathic corneal pain subjects. Urcosimod has shown significant pain reduction in an earlier 240 subject Phase 2, multi-center, double-masked, placebo-controlled trial in DED, which supports the development rationale in NCP.

About OKYO Pharma

OKYO Pharma Limited (Nasdaq: OKYO) is a clinical-stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain (NCP) and inflammatory eye diseases, with ordinary shares listed for trading on the Nasdaq Capital Market. OKYO is focused on the discovery and development of novel molecules to treat neuropathic corneal pain and other ocular diseases. OKYO recently completed a successful phase 2 trial of its flagship drug urcosimod in subjects with NCP and plans to initiate a ~150 subject Phase 2b/3 multiple-dose study of urcosimod to treat NCP in the first half of this year.

For further information, please visit www.okyopharma.com.

Inquiries:

Business Development & Investor Relations Paul Spencer +44 (0)20 7495 2379