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• Study met primary endpoint of mean Total Improvement Score (TIS) at Week 52 in the combined study population of IMNM and DM patients (p=0.0011)
• Patient improvements observed early and sustained throughout study; consistent treatment effect across IMNM and DM
• First Phase 3 study to show statistically significant and clinically meaningful improvements in disease activity in IMNM, a subtype with no approved therapy
• argenx to host a conference call on August 17
  
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August 17, 2026, 7:00 AM CET

Amsterdam, the Netherlands – argenx SE (Euronext & Nasdaq: ARGX), a global immunology innovation company, today announced positive topline results from the ALKIVIA Phase 3 study evaluating VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) in adults with autoimmune myositis.

Study met its primary endpoint (p=0.0011)

• In the combined immune-mediated necrotizing myopathy (IMNM) and dermatomyositis (DM) population, patients treated with efgartigimod demonstrated statistically significant and clinically meaningful 15.4-point greater improvement in mean Total Improvement Score (TIS) at Week 52 versus placebo (47.95 vs 32.56).

Rapid and sustained treatment benefit

• In the combined population, patients treated with efgartigimod consistently showed improvements over placebo starting at Week 4 that were statistically significant and sustained through the full year of treatment, even with steroid tapering.

Magnitude of clinical improvement consistent across both IMNM and DM

• In prespecified subtype analyses, the primary endpoint of Mean TIS at 52 weeks was also met in IMNM patients treated with efgartigimod (p=0.0048), with a 14.8-point greater improvement over placebo (45.05 vs 30.24). In DM, a similar clinically meaningful improvement of 14.5 points (p=0.1093) was observed (51.51 vs 36.96), though statistical significance was not reached in this smaller cohort.

Clinical impact observed in both muscle and skin measures

• In both IMNM and DM, all six core set measures of TIS contributed to the treatment effect, each favoring efgartigimod over placebo, spanning muscle strength, everyday physical function, and disease activity beyond the muscle. In DM, improvement in skin disease activity was also observed.

Efgartigimod was well-tolerated by patients in the ALKIVIA study. The observed safety profile was consistent with prior studies and the known safety profile of efgartigimod.

“For decades, people living with autoimmune myositis have relied on corticosteroids and broad immunosuppression, and those with IMNM have had no approved option at all. These are the first Phase 3 results to show that precision targeting of FcRn with efgartigimod can deliver meaningful benefit in this disease,” said Luc Truyen, M.D., Ph.D., Chief Medical Officer at argenx. “The patient response to efgartigimod was durable and multidimensional: separation from placebo emerged early and held through a full year of treatment, with a treatment effect of comparable magnitude in IMNM and DM. This confirms that pathogenic IgG autoantibodies are key drivers of autoimmune myositis. We are grateful to the patients, caregivers, and investigators who made this pioneering study possible.”

“For people living with myositis, the goal is straightforward: regain strength and function, and get off long-term steroids. Until now we have had limited targeted therapies to offer patients,” said Rohit Aggarwal, M.D., M.S., Professor of Medicine and Co-Director of the Myositis Center at the University of Pittsburgh, and an ALKIVIA investigator. “IMNM is the most refractory form of this disease and many of these patients carry irreversible muscle damage, which makes meaningful improvement genuinely difficult to achieve. That is what makes these results so compelling and groundbreaking. In DM, the magnitude of improvement was comparable – and for a community where treatment options remain limited and the burden of chronic steroids is just as heavy, that matters. Together, these results tell us that reducing pathogenic autoantibodies is clinically meaningful and a major step forward for patients who are in need of a targeted treatment.”

Detailed results from the ALKIVIA study will be presented at an upcoming medical meeting.

Efgartigimod continues to be evaluated as a potential treatment in other autoimmune rheumatologic diseases, including Sjögren’s disease and systemic sclerosis.

argenx Conference Call Details

argenx will host an investor conference call and webcast today at 2:30 PM CET/ 8:30 AM ET to discuss the results. A webcast of the conference call may be accessed on the Investors section of the argenx website at argenx.com/investors.

Participants can access the conference call by dialing 800-590-8290 (United States and Canada) or 240-690-8800 (International). Country specific dial-in numbers are listed below:

Belgium                32 2290 4635
France                        33 172 001717
Netherlands                31 20 795 2683
United Kingdom        44 203 393 1560
Japan                        81 3 4520 9761
Switzerland                41 43 210 51 68

Use the access code 3810049 to join the call. Please dial in 15 minutes prior to the live call.

A replay of the webcast will be available on the argenx website.

About the ALKIVIA Study

The ALKIVIA study was a global, randomized, double-blind, placebo-controlled, multicenter, operationally seamless Phase 2/3 study of efgartigimod SC for the treatment of autoimmune myositis across IMNM, DM and PM. The ALKIVIA study enrolled 264 patients who had active disease and were on background treatment. Participants were randomized (1:1) to receive weekly injections of efgartigimod PH20 SC or matched to placebo PH20 SC. The study was conducted in two phases, with an analysis of the Phase 2 portion of the clinical trial after the first 89 patients completed the study, followed by Phase 3. The Phase 3 study enrolled 175 patients and included a protocol-mandated corticosteroid taper throughout the study. The primary endpoint of Phase 3 was the mean Total Improvement Score (TIS) at the end of the treatment period of 52 weeks of all treated patients compared to placebo. Prespecified analyses evaluated the combined IMNM and DM population and each subtype separately.

ALKIVIA was conducted globally across North America, Europe, the Middle East, and Asia-Pacific, including China and Japan. argenx has an exclusive license agreement with Zai Lab for the development and commercialization of VYVGART and VYVGART Hytrulo in Greater China. Through this agreement, Zai Lab recruited Chinese patients into the ALKIVIA trial.

About Autoimmune Myositis

Autoimmune myositis is a heterogenous disease spectrum with autoimmune-mediated pathophysiology, characterized by chronic inflammation and progressive muscle weakness, and in some subtypes by skin involvement and other extramuscular manifestations. Proximal muscle weakness is a hallmark clinical feature across subtypes.

Approximately 100,000 people in the United States live with autoimmune myositis, including approximately 20,000 with IMNM and approximately 40,000 with DM. Up to 80 percent of patients report long-term disability despite treatment. There are currently no targeted treatments available, and care and treatment relies primarily on corticosteroids and broad immunosuppressants, which are associated with significant cumulative toxicity, including metabolic, cardiovascular, musculoskeletal and infectious complications.

Advances in the understanding of autoimmune myositis biology have highlighted the central role of antibody-mediated immunity, with pathogenic IgG autoantibodies contributing to muscle fiber damage and extramuscular manifestations across subtypes. FcRn maintains circulating IgG levels by recycling IgG antibodies, including pathogenic autoantibodies. Efgartigimod is designed to selectively block FcRn, reducing pathogenic IgG autoantibodies while preserving other aspects of immune function.

About VYVGART

VYVGART® (efgartigimod alfa fcab) is a first-in-class human IgG1 antibody fragment that binds to the neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG autoantibodies. VYVGART Hytrulo® is a subcutaneous combination of efgartigimod alfa (VYVGART) and recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE® drug delivery technology to facilitate subcutaneous injection delivery of biologics. VYVGART is approved for generalized myasthenia gravis (gMG) and immune thrombocytopenia (Japan only). VYVGART Hytrulo is approved for gMG and chronic inflammatory demyelinating polyneuropathy (CIDP). VYVGART Hytrulo may be marketed under different proprietary names in other regions.

About argenx

argenx is a global immunology innovation company committed to improving the lives of people suffering from severe autoimmune diseases. Partnering with leading academic researchers through its Immunology Innovation Program (IIP), argenx aims to translate immunology breakthroughs into a world-class portfolio of novel antibody-based medicines. argenx developed and is commercializing the first approved neonatal Fc receptor (FcRn) blocker and is evaluating its broad potential in multiple serious autoimmune diseases while advancing several earlier stage experimental medicines within its therapeutic franchises. For more information, visit  www.argenx.com  and follow us on LinkedIn, Instagram, Facebook, and YouTube.

This press release contains inside information within the meaning of Article 7(1) of the EU Market Abuse Regulation (Regulation 596/2014).

Media Contact

Colin McBean
[email protected]

Investor Contact

Alexandra Roy
[email protected]

Forward-Looking Statements

The contents of this press release include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements generally can be identified by the use of forward-looking words, such as “aim”, “anticipate”, “aspire”, “believe”, “can”, “continue”, “could”, “estimate”, “expect”, “entail”, “forecast”, “future”, “goals”, “hope”, “intend”, “is designed to”, “likely”, “may”, “might”, “objective”, “plan”, “possible”, “potential”, “pursue”, “project”, “predict”, “seek”, “should”, “strategy”, “target”, “will” and other words and terms of similar meaning and expression, including in connection with any discussion of future operating or financial performance. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including but not limited to, the results of argenx’s clinical trials; uncertainties associated with the development of novel drug therapies; preclinical and clinical trial and product development risks and setbacks; interpretation of argenx’s clinical trial data by regulatory authorities and argenx’s ability to obtain regulatory approval; the risk that early stage clinical trials may not be predictive of results in later stage or large scale clinical trials; the occurrence of adverse safety events or participant dropouts; the acceptance of its products and product candidates by its patients as safe, effective, and cost-effective; the impact of governmental laws and regulations, including tariffs, export controls, sanctions and other regulations on its business; the impact of healthcare regulations, including rules on reimbursement for argenx’s products; competition in drug discovery, development and commercialization efforts; its reliance on third-party suppliers, service providers and manufacturers; and instability and conflicts in the regions in which the company has suppliers or markets for its products. A further list and description of these and other risks, uncertainties, and factors that could cause actual results to differ materially from those referred to in the forward-looking statements can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in argenx’s most recent annual report on Form 20-F filed with the SEC as well as subsequent filings and reports filed by argenx with the SEC. Given these risks and uncertainties, the reader is advised not to place undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this press release. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.

Genco Board Provided Diana Clear Criteria for a Transaction Reflecting Fair Value and in the Best Interests of All Genco Shareholders 

Genco Sets the Record Straight on Diana’s Misleading Characterization of the Negotiations and Genco’s Transaction Framework

Genco Is Firing on All Cylinders with Increased and Compelling Dividends Projected for 2026

NEW YORK, Aug. 17, 2026 (GLOBE NEWSWIRE) — Genco Shipping & Trading Limited (NYSE:GNK) (“Genco” or the “Company”), the largest U.S. headquartered drybulk shipowner focused on the global transportation of commodities, today issued an open letter to Genco shareholders following the announcement by Diana Shipping Inc. (“Diana”) that Diana has withdrawn its offer to acquire all outstanding Genco shares not already owned by Diana:

Dear Genco Shareholders:

We are reaching out today to thank you for your continued support during this important and exciting time for Genco. We are executing our Comprehensive Value Strategy, delivering strong results and shareholder returns. Importantly, we are well positioned to continue to deliver compelling results for shareholders in the strengthening drybulk market.

For the last several months, Diana Shipping has waged a campaign to take over Genco at a discount through tactics that included multiple unsolicited public offers, a proxy fight and a hostile and deceptive tender offer. At every step, Diana disseminated misleading information designed to confuse our shareholders and distract you from their simple agenda: take over Genco without paying full and fair value.

Our Board is committed to maximizing shareholder value. To that end, we engaged appropriately with Diana throughout the process. From the outset, we provided a clear framework: any offer to acquire Genco needs to compensate shareholders for our net asset value (NAV) and include an appropriate control premium.

At the annual shareholder meeting on June 18, 2026, Genco shareholders overwhelmingly supported the Board. Since that time, the Board and advisors have continued to thoroughly evaluate the latest Diana proposal, together with various factors that could impact valuation. Our advisors held several meetings with Diana’s advisors to advance discussions.

Recently, on August 13, 2026, Genco’s advisors attempted to negotiate improvements to Diana’s latest proposal to potentially reach a transaction that met the criteria outlined above. We explicitly told Diana that we “stand ready to engage further to explore whether we can find an agreement that meets the requirements outlined above and delivers full and fair value to Genco shareholders.”

It is important that shareholders understand the following:

• • We believe Diana has repeatedly overstated the value of the shares proposed to be issued as consideration in the transaction. Based on the framework our advisors conveyed to Diana, and taking into account the significant shareholder dilution that would result, we calculate that Diana shares on a pro forma basis would likely be materially lower than their current market value.
  • Based on our pro forma valuation of Diana shares and Diana’s stated intent to deduct Genco’s Q2 2026 dividend of $0.80 per share, the Diana proposal that the Genco Board was considering was believed to be valued at well below Genco’s $27.50 NAV. Dividends declared in later quarters before closing would only further diminish the value of the consideration paid by Diana.

Instead of responding to our private communication or providing a counterproposal, Diana withdrew its offer and issued yet another misleading public press release. In its disclosure, Diana grossly inflated the value of our framework as $36.91 per Genco share.

To set the record straight, our advisors conveyed to Diana a framework for a transaction at $27.50 per share in cash plus three Diana shares. Our framework contemplates:

• • Cash at NAV that ensures Genco shareholders are properly compensated for the underlying value of our assets: Both independent third-party broker valuations and the median of five sell-side analyst estimates have Genco’s NAV at approximately $27.50 per share. We believe this is a compelling baseline, given that valuations across the industry are expected to continue rising as the fundamentals of the drybulk market remain positive. Moreover, Diana continued to emphasize that they had committed financing of $1.412 billion. If this was true, they would have sufficient capital to fund the cash portion of the transaction.

  • Stock consideration that provides an appropriate premium: We proposed consideration of three Diana shares per Genco share, as an appropriate level. We valued Diana shares under this proposal at approximately $1 per share. A single Diana share does not provide compelling value for Genco shareholders.

    Moreover, we believe there is considerable incremental risk to owning Diana shares, given Diana’s super-voting preferred share structure, its majority insider control, its longstanding record of poor governance and related party transactions and its lagging and antiquated commercial strategy – all of which we believe have contributed to Diana’s severely lagging valuation and performance.

• • Genco shareholders keep their dividends. Diana stated that its offer would be reduced for our quarterly dividends, transferring value away from Genco shareholders. Our position was that Genco shareholders should receive the dividends in respect of earnings during the period of their ownership.

    In typical M&A transactions, companies generally continue to pay their normal dividends through closing. Our shareholders should not be penalized because of the transaction and should receive the dividends they otherwise would have.

Given all of this, Diana misleadingly inflated the value of our framework.

We believe Diana’s most recent actions indicate they only wanted to acquire Genco below NAV, which raises serious questions about Diana’s ability to complete a transaction that benefits all Genco shareholders.

The Path Forward: Executing our Comprehensive Value Strategy, Driving Returns and Creating Shareholder Value

Genco is firing on all cylinders. Our Board continues to oversee the execution of our Comprehensive Value Strategy, which is delivering superior returns to shareholders. We recently reported strong second quarter results, including a Comprehensive Value Strategy record $0.80 per share dividend. Since 2021, we have provided shareholders with dividends totaling $8.715 per share, representing 28 consecutive quarterly payments and the longest stretch in our drybulk peer group.

We expect shareholders to continue benefitting from the deliberate steps we’ve taken to grow our premium earning fleet and increase our earnings and dividend power. Looking ahead, we have projected cumulative dividends for Q3 and Q4 of 2026 of more than $2.00 per share.¹

We take our role as stewards of Genco shareholders’ investments seriously. We are moving full speed ahead with our Comprehensive Value Strategy to continue driving superior returns and value for shareholders in a strengthening drybulk market.

Thank you again.

Sincerely,

Jefferies LLC is acting as financial advisor to Genco and Herbert Smith Freehills Kramer (US) LLP and Sidley Austin LLP are serving as legal counsel to Genco. Morgan Stanley & Co. LLC is acting as special advisor to the Board of Directors.

About Genco Shipping & Trading Limited

Genco Shipping & Trading Limited is a U.S. based drybulk ship owning company focused on the seaborne transportation of commodities globally. We transport key cargoes such as iron ore, coal, grain, steel products, bauxite, cement, nickel ore among other commodities along worldwide shipping routes. Our wholly owned high quality, modern fleet of dry cargo vessels consists of the larger Newcastlemax and Capesize vessels (major bulk) and the medium-sized Ultramax and Supramax vessels (minor bulk), enabling us to carry a wide range of cargoes. Genco’s fleet consists of 44 vessels with an average age of 12.7 years and an aggregate capacity of approximately 5,117,000 dwt.

Forward-Looking Statements

This release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements use words such as “anticipate,” “budget,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe,” and other words and terms of similar meaning in connection with a discussion of potential future events, circumstances or future operating or financial performance. These forward-looking statements are based on our management’s current expectations and observations. Included among the factors that, in our view, could cause actual results to differ materially from the forward looking statements contained in this release are the following: (i) declines or sustained weakness in demand in the drybulk shipping industry; (ii) weakness or declines in drybulk shipping rates; (iii) changes in the supply of or demand for drybulk products, generally or in particular regions; (iv) changes in the supply of drybulk carriers including newbuilding of vessels or lower than anticipated scrapping of older vessels; (v) changes in rules and regulations applicable to the cargo industry, including, without limitation, legislation adopted by international organizations or by individual countries and actions taken by regulatory authorities; (vi) increases in costs and expenses including but not limited to: crew wages, insurance, provisions, lube oil, bunkers, repairs, maintenance, general and administrative expenses, and management expenses; (vii) whether our insurance arrangements are adequate; (viii) changes in general domestic and international political conditions; (ix) military actions, terrorism, or piracy, including without limitation the ongoing conflicts in Ukraine and Iran, related attacks on commercial vessels, and other conflicts in the Middle East; (x) changes in the condition of the Company’s vessels or applicable maintenance or regulatory standards (which may affect, among other things, our anticipated drydocking or maintenance and repair costs) and unanticipated drydock expenditures; (xi) the Company’s acquisition or disposition of vessels; (xii) the amount of offhire time needed to complete maintenance, repairs, and installation of equipment to comply with applicable regulations on vessels and the timing and amount of any reimbursement by our insurance carriers for insurance claims, including offhire days; (xiii) the completion of definitive documentation with respect to charters; (xiv) charterers’ compliance with the terms of their charters in the current market environment; (xv) the extent to which our operating results are affected by weakness in market conditions and freight and charter rates; (xvi) our ability to maintain contracts that are critical to our operation, to obtain and maintain acceptable terms with our vendors, customers and service providers and to retain key executives, managers and employees; (xvii) completion of documentation for vessel transactions and the performance of the terms thereof by buyers or sellers of vessels and us; (xviii) the relative cost and availability of low sulfur and high sulfur fuel, worldwide compliance with sulfur emissions regulations that took effect on January 1, 2020 and our ability to realize the economic benefits or recover the cost of the scrubbers we have installed; (xix) our financial results for the year ending December 31, 2026 and other factors relating to determination of the tax treatment of dividends we have declared; (xx) the financial results we achieve for each quarter that apply to the formula under our dividend policy, including without limitation the actual amounts earned by our vessels and the amounts of various expenses we incur, as a significant decrease in such earnings or a significant increase in such expenses may affect our ability to carry out our new value strategy; (xxi) the exercise of the discretion of our Board regarding the declaration of dividends, including without limitation the amount that our Board determines to set aside for reserves under our dividend policy; (xxii) outbreaks of disease such as the COVID-19 pandemic; (xxiii) trade conflicts, the imposition or modification of port fees, tariffs and other import restrictions, and the effectiveness and cost of any measures the Company may adopt to avoid or mitigate the impact of the foregoing, including alternate trade routes and repositioning vessels; and (xxiv) other factors listed from time to time in our filings with the Securities and Exchange Commission, including, without limitation, our Annual Report on Form 10-K for the year ended December 31, 2025 and subsequent reports on Form 8-K and Form 10-Q). Our ability to pay dividends in any period will depend upon various factors, including the limitations under any credit agreements to which we may be a party, applicable provisions of Marshall Islands law and the final determination by the Board of Directors each quarter after its review of our financial performance, market developments, and the best interests of the Company and its shareholders. The timing and amount of dividends, if any, could also be affected by factors affecting cash flows, results of operations, required capital expenditures, or reserves. As a result, the amount of dividends actually paid may vary. We do not undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact

Peter Allen
Chief Financial Officer
Genco Shipping & Trading Limited
(646) 443-8550

Media Contact

Leon Berman
IGB Group
(212) 477-8438
[email protected]

___________________________
¹ Q3 and Q4 2026 projected dividends are based on fixtures to date (representing 66% of our owned fleet available days for Q3), assuming the current FFA curve for the balance of the quarters and estimated expense levels and utilization as described in the appendix to our Q2 2026 earnings presentation posted on our website under “Investors – Events and Presentations.” Given freight market volatility, the FFA curve is subject to change.

VANCOUVER, British Columbia, Aug. 16, 2026 (GLOBE NEWSWIRE) — Endeavour Silver Corp. (“Endeavour” or the “Company”) (NYSE: EXK; TSX: EDR) reports that operations at its Terronera mine in Jalisco, Mexico have been temporarily suspended since August 12^th as the result of an illegal blockade by members of the nearby Ejido community regarding their concerns over road maintenance, assistance with medical services and communications, control and access to water supply and increased financial assistance. To date, the blockade has remained peaceful, orderly and respectful.

The site remains staffed with a reduced workforce to support safety and security protocols and continues to be accessible for maintenance activities. The Company continues active discussions with Ejido community leaders to resolve the matter and resume full operations as soon as possible. The Company has the ability to pursue legal action and will exercise all available legal remedies if this matter is prolonged.

About Endeavour Silver – Endeavour is a mid-tier silver producer with three operating mines in Mexico and Peru and a robust pipeline of exploration projects across Mexico, Chile, and the United States. With a proven track record of discovery, development, and responsible mining, Endeavour is driving organic growth and creating lasting value on its path to becoming a leading senior silver producer.

Contact Information

Allison Pettit
Vice President, Investor Relations
Email: [email protected]
Website: www.edrsilver.com

Cautionary Note Regarding Forward-Looking Statements

This news release contains “forward-looking statements” within the meaning of the United States private securities litigation reform act of 1995 and “forward-looking information” within the meaning of applicable Canadian securities legislation. Such forward-looking statements and information herein include but are not limited to statements regarding ongoing discussions with community leaders; the exercise of legal remedies; continued accessibility at Terronera; the resolution of the illegal blockade and resumption of full operations at Terronera and related timing; Endeavour’s ability to drive organic growth and create lasting value, and the timing and results of various activities. The Company does not intend to and does not assume any obligation to update such forward-looking statements or information, other than as required by applicable law.

Forward-looking statements or information involve known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, production levels, performance or achievements of Endeavour and its operations to be materially different from those expressed or implied by such statements. Such factors include but are not limited to unexpected changes in production and costs guidance; the ongoing effects of inflation and supply chain issues on mine economics; fluctuations in the prices of silver and gold; fluctuations in the currency markets (particularly the Mexican peso, Peruvian sol, Canadian dollar, Chilean peso, and U.S. dollar); fluctuations in interest rates; effects of inflation; changes in national and local governments, legislation, taxation, controls, regulations and political or economic developments in Canada, Peru and Mexico; operating or technical difficulties in mineral exploration, development and mining activities; risks and hazards of mineral exploration, development and mining (including, but not limited to, environmental hazards, industrial accidents, unusual or unexpected geological conditions, pressures, cave-ins and flooding); inadequate insurance, or inability to obtain insurance; availability of and costs associated with mining inputs and labour; the speculative nature of mineral exploration and development; diminishing quantities or grades of mineral reserves as properties are mined; risks in obtaining necessary licenses and permits; and challenges to the Company’s title to properties; as well as those factors described in the section “risk factors” contained in the Company’s most recent form 40F/Annual Information Form filed with the S.E.C. and Canadian securities regulatory authorities.

Forward-looking statements are based on assumptions management believes to be reasonable, including but not limited to: the continued operation of the Company’s mining operations, no material adverse change in the market price of commodities, forecasted mine economics, mining operations will operate and the mining products will be completed in accordance with management’s expectations and achieve their stated production outcomes, and such other assumptions and factors as set out herein. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements or information, there may be other factors that cause results to be materially different from those anticipated, described, estimated, assessed or intended. There can be no assurance that any forward-looking statements or information will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements or information. Accordingly, readers should not place undue reliance on forward-looking statements or information.

NEW YORK, Aug. 16, 2026 (GLOBE NEWSWIRE) — Mesoblast Limited (Nasdaq:MESO; ASX:MSB), global leader in allogeneic cellular medicines for inflammatory diseases, today announced that it has completed patient treatment in the MSB-DR004 pivotal randomized controlled Phase 3 trial of rexlemestrocel-L for chronic low back pain (CLBP) associated with the inflammatory condition of degenerative disc disease. The major milestone was achieved with 350 patients randomized and treated with either an intra-discal injection of rexlemestrocel-L or sham injection. Total patient numbers treated increased from 300 to 350 after strong demand from trial investigators to have their patients enrolled in the innovative program.

The trial’s primary endpoint aims to confirm the durable pain reduction at 12 months from a single intra-discal injection of rexlemestrocel-L seen in the earlier MSB-DR003 trial. With 350 treated patients, the trial is well-powered for showing a greater treatment benefit in patients receiving rexlemestrocel-L compared with controls. Secondary endpoints include improvements in function, quality of life, and cessation of pain medication, including opioids.

Silviu Itescu, Chief Executive of Mesoblast, said: “Completing treatment of 350 patients in our pivotal low back pain trial is a momentous milestone for the company as we now count down to the 12-month read-out for what we hope will be the basis of our first blockbuster product.”

CLBP caused by inflammation and degenerative disc disease is a serious condition with a prevalence of over 7 million people in the U.S. alone. The indication has potential peak year revenue of >US$10 billion for Mesoblast even with just single digit market penetration.

Rexlemestrocel-L has Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA) for treatment of CLBP due to degenerative disc disease providing eligibility for priority review once the Biologics License Application (BLA) has been filed. Top-line results are expected in mid-CY2027 after the last treated patient has completed 12 months follow-up.

About Rexlemestrocel-L for Chronic Low Back Pain associated with Degenerative Disc Disease

Mesoblast’s second generation allogeneic, STRO3-immunoselected, and industrially manufactured stromal cell product candidate rexlemestrocel-L is being evaluated in patients with chronic low back pain (CLBP) due to inflammatory degenerative disc disease (DDD) of less than five years duration. Mesoblast has agreement with FDA on the design of the randomized, placebo-controlled pivotal Phase 3 trial and on the trial’s 12-month primary endpoint of pain reduction, previously successfully met in Mesoblast’s first Phase 3 trial, as an approvable indication. Key secondary measures include improvement in quality of life and function. A further secondary endpoint will be reduction in opioid use since discogenic back pain accounts for approximately 50% of opioid prescriptions in the U.S.

About Chronic Low Back Pain

Back pain is the leading cause of disability in Americans under 45 years,¹ with an annual prevalence in the general US adult population of 10-30%.² CLBP caused by inflammation and degenerative disc disease (DDD) is a serious condition with a prevalence of over 7 million people in the US alone.^3,4 CLBP due to DDD is a leading cause of disability, and is associated with impaired quality of life, severe limitations in ability to perform activities of daily living, reduced ability to work, and negative impacts on mental health. CLBP accounts for approximately 50% of prescription opioid usage in the US,⁴ making the condition a significant contributor to the opioid epidemic.

About Mesoblast

Mesoblast (the Company) is a world leader in developing allogeneic (off-the-shelf) cellular medicines for the treatment of severe and life-threatening inflammatory conditions. The therapies from the Company’s proprietary mesenchymal lineage cell therapy technology platform respond to severe inflammation by releasing anti-inflammatory factors that counter and modulate multiple effector arms of the immune system, resulting in significant reduction of the damaging inflammatory process.

Mesoblast’s Ryoncil^® (remestemcel-L-rknd) for the treatment of steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients 2 months and older is the first FDA-approved mesenchymal stromal cell (MSC) therapy. Please see the full Prescribing Information at www.ryoncil.com.

Mesoblast is committed to developing additional cell therapies for distinct indications based on its remestemcel-L and rexlemestrocel-L allogeneic stromal cell technology platforms. Ryoncil^® is being developed for additional inflammatory diseases including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease. Rexlemestrocel-L is being developed for heart failure and chronic low back pain. The Company has established commercial partnerships in Japan, Europe and China.

About Mesoblast intellectual property: Mesoblast has a strong and extensive global intellectual property portfolio, with over 1,000 granted patents or patent applications covering mesenchymal stromal cell compositions of matter, methods of manufacturing and indications. These granted patents and patent applications provide commercial protection extending through to at least 2044 in all major markets.

About Mesoblast manufacturing: The Company’s proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf, cellular medicines. These cell therapies, with defined pharmaceutical release criteria, are planned to be readily available to patients worldwide.

Mesoblast has locations in Australia, the United States and Singapore and is listed on the Australian Securities Exchange (MSB) and on the Nasdaq (MESO). For more information, please see www.mesoblast.com, LinkedIn: Mesoblast Limited and Twitter: @Mesoblast

References / Footnotes

1. American Academy of Pain Medicine – Get the Facts on Pain. The American Academy of Pain Medicine. http://www.painmed.org/patientcenter/facts-on-pain/ Accessed on June 28, 2017.
2. Urits I, Burshtein A, Sharma M, et al. Low Back Pain, a Comprehensive Review: Pathophysiology, Diagnosis, and Treatment. Current Pain and Headache Reports. 2019;23(3):1-10. doi:10.1007/s11916-019-0757-1.
3. Navigant: Commercial Assessment for a Proprietary Cell-Based Therapy for DDD in the U.S. and the EU3 – August 2014.
4. Decision Resources: Chronic Pain December 2015.

Forward-Looking Statements

This press release includes forward-looking statements that relate to future events or our future financial performance and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. Forward-looking statements include, but are not limited to, statements about: the initiation, timing, progress and results of Mesoblast’s preclinical and clinical studies, and Mesoblast’s research and development programs; Mesoblast’s ability to advance product candidates into, enroll and successfully complete, clinical studies, including multi-national clinical trials; Mesoblast’s ability to advance its manufacturing capabilities; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities, if any; the commercialization of Mesoblast’s RYONCIL for pediatric SR-aGVHD and any other product candidates, if approved; regulatory or public perceptions and market acceptance surrounding the use of stem-cell based therapies; the potential for Mesoblast’s product candidates, if any are approved, to be withdrawn from the market due to patient adverse events or deaths; the potential benefits of strategic collaboration agreements and Mesoblast’s ability to enter into and maintain established strategic collaborations; Mesoblast’s ability to establish and maintain intellectual property on its product candidates and Mesoblast’s ability to successfully defend these in cases of alleged infringement; the scope of protection Mesoblast is able to establish and maintain for intellectual property rights covering its product candidates and technology; estimates of Mesoblast’s expenses, future revenues, capital requirements and its needs for additional financing; Mesoblast’s financial performance; developments relating to Mesoblast’s competitors and industry; and the pricing and reimbursement of Mesoblast’s product candidates, if approved. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

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