Core Insights - Mesoblast Limited is a global leader in allogeneic cellular medicines for inflammatory diseases and is participating in the Piper Sandler 37th Annual Healthcare Conference in New York from December 2–4, 2025 [1][2] Company Overview - Mesoblast specializes in developing allogeneic (off-the-shelf) cellular medicines aimed at treating severe and life-threatening inflammatory conditions, utilizing a proprietary mesenchymal lineage cell therapy technology platform [3] - The company has a strong intellectual property portfolio with over 1,000 granted patents or patent applications, providing commercial protection extending through at least 2044 in major markets [6] Product Development - Mesoblast's Ryoncil (remestemcel-L-rknd) is the first FDA-approved mesenchymal stromal cell therapy for treating steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients aged 2 months and older [4] - The company is developing additional therapies for various inflammatory diseases, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, as well as rexlemestrocel-L for heart failure and chronic low back pain [5] Manufacturing Capabilities - Mesoblast employs proprietary manufacturing processes that yield industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring these therapies are readily available to patients worldwide [7] Global Presence - The company operates in Australia, the United States, and Singapore, and is listed on both the Australian Securities Exchange (MSB) and Nasdaq (MESO) [8]

Core Insights - U.S. stocks experienced an upward trend, with the Dow Jones increasing by over 300 points on Wednesday [1] - Urban Outfitters Inc reported third-quarter earnings per share (EPS) and sales that exceeded analyst expectations, leading to a significant rise in its stock price [1][2] Urban Outfitters Inc - The company reported quarterly earnings of $1.28 per share, surpassing the Street estimate of $1.18 by 8.11% [2] - Quarterly revenue reached $1.53 billion, exceeding the analyst estimate of $1.47 billion and showing an increase from $1.36 billion in the same period last year [2] - Urban Outfitters shares surged by 10.1% to $75.21 following the earnings report [2] Other Notable Stocks - Falcon's Beyond Global Inc shares increased by 26% to $18.02 [4] - Ironwood Pharmaceuticals, Inc. shares rose by 18.7% to $3.72 [4] - YD Bio Ltd shares gained 18.1% to $10.97 after announcing 510(k) clearance and plans for a clinical trial [4] - SuperX AI Technology Ltd shares rose by 17.5% to $25.78 following a $20 million share repurchase program authorization [4] - Arrowhead Pharmaceuticals Inc shares jumped by 17.4% to $54.94 after reporting better-than-expected quarterly results [4] - Petco Health and Wellness Company Inc shares surged by 14.6% to $3.40 after reporting better-than-expected third-quarter EPS results [4] - Robinhood Markets Inc shares rose by 8.8% to $125.83 after announcing the introduction of a futures and derivatives exchange and the acquisition of 90% of MIAX Derivatives Exchange [4]

Group 1: Autodesk Inc - Autodesk reported third-quarter revenue of $1.85 billion, an 18% increase year-over-year, surpassing analyst estimates of $1.81 billion [1] - The company achieved adjusted earnings of $2.67 per share, exceeding estimates of $2.50 per share [1] - Following the earnings report, Autodesk shares surged 6.1% to $312.50 in pre-market trading [1] Group 2: Other Stocks in Pre-Market Trading - Mobile-Health Network Solutions saw a 45.4% increase to $2.76 after filing to increase its at-the-market offering capacity to $2.26 million from $1.25 million [5] - Inno Holdings Inc rose 29.5% to $0.35 after signing a memorandum of understanding with Megabyte Solutions for Web3 technology applications [5] - KALA BIO Inc gained 24.1% to $0.79 after entering a Securities Purchase Agreement to raise up to $6 million [5] - Urban Outfitters Inc rose 17.4% to $80.19 after reporting third-quarter EPS and sales above analyst estimates [5] - Nutanix Inc tumbled 16.8% to $48.86 after reporting worse-than-expected first-quarter results and cutting FY26 sales guidance [5] - Zscaler Inc fell 7.2% to $269.00 following the release of its first-quarter financial results [5]

Core Viewpoint - Mesoblast Limited, a leader in allogeneic cellular medicines for inflammatory diseases, provided a trading update and operational overview during the Chief Executive's Annual General Meeting, highlighting significant revenue growth and ongoing development of its therapies [1][2]. Financial Performance - For the quarter ending December 31, 2025, Mesoblast expects gross revenue exceeding US$30.0 million from Ryoncil sales, marking a more than 37% increase from US$21.9 million in the previous quarter [2]. Product Overview - Ryoncil (remestemcel-L-rknd) is the first FDA-approved mesenchymal stromal cell therapy for treating steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients aged 2 months and older [4]. - The company is also developing Ryoncil for additional inflammatory diseases, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease [5]. Technology and Intellectual Property - Mesoblast has a robust global intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection until at least 2044 in major markets [6]. - The proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring availability to patients worldwide [7]. Global Presence - Mesoblast operates in Australia, the United States, and Singapore, and is listed on both the Australian Securities Exchange (MSB) and Nasdaq (MESO) [8].

Core Insights - Mesoblast Limited is collaborating with the NIH-funded Blood and Marrow Transplant Clinical Trials Network to conduct a pivotal trial of Ryoncil for adults with severe steroid-refractory acute graft versus host disease (SR-aGvHD) [1][2][3] - The trial aims to address the high mortality rates in patients who do not respond to corticosteroids, with survival rates as low as 20-30% by Day 100 after failing ruxolitinib [2] - Ryoncil has shown promising results in pediatric patients, with a 76% survival rate at Day 100 in adults who failed other treatments [2][5] Company Overview - Mesoblast is a leader in developing allogeneic cellular medicines for severe inflammatory diseases, utilizing a proprietary mesenchymal lineage cell therapy technology platform [4][6] - The company has a strong intellectual property portfolio with over 1,000 patents or applications, providing commercial protection until at least 2044 [7] - Mesoblast is expanding its product offerings, with Ryoncil being developed for additional indications beyond SR-aGvHD, including biologic-resistant inflammatory bowel disease and heart failure [6] Clinical Development - The pivotal trial for Ryoncil will randomize patients as early as possible after corticosteroid refractoriness, comparing ruxolitinib alone versus ruxolitinib combined with Ryoncil [3] - The trial protocol is set to be submitted to the FDA to initiate enrollment in the first quarter of 2026 [3] - The collaboration with BMT CTN is significant as it represents U.S. centers performing approximately 80% of all U.S. allogeneic bone marrow transplants [1][10]

Core Insights - Mesoblast Limited has appointed James M. O'Brien as the new Chief Financial Officer (CFO) to support its transition to a fully integrated commercial organization [1][2] - The company aims to enhance its financial leadership as it commercializes its product Ryoncil and seeks label expansion [2] Company Overview - Mesoblast is a global leader in developing allogeneic cellular medicines for severe inflammatory diseases, utilizing proprietary mesenchymal lineage cell therapy technology [3] - The company has a strong intellectual property portfolio with over 1,000 patents or applications, providing commercial protection until at least 2044 in major markets [6] Product Development - Ryoncil (remestemcel-L-rknd) is the first FDA-approved mesenchymal stromal cell therapy for treating steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients aged 2 months and older [4] - Mesoblast is developing additional therapies for various inflammatory diseases, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, as well as heart failure and chronic low back pain [5] Financial Leadership - James M. O'Brien brings extensive experience in financial management from previous roles at Actavis plc, Cognition Therapeutics, and Faron Pharmaceuticals, among others [2] - His expertise includes overseeing corporate finance, reporting, internal controls, and accounting operations, with a history of managing transactions totaling nearly $10 billion [2]

Core Insights - Mesoblast Limited reported significant revenue growth driven by increased adoption of its product Ryoncil, with a permanent J-Code enhancing billing and reimbursement processes [2][4]. Financial Highlights - Revenue from cell therapy products reached US$20.6 million for the quarter ended September 30, 2025, up from US$12.9 million in the previous quarter, and over ten times greater than the same quarter last year [4]. - Ryoncil gross sales increased by 66% to US$21.9 million, while net sales rose by 69% to US$19.1 million after a 12.7% gross to net adjustment [4]. - The company reported a net operating cash spend of US$14.9 million, a reduction of US$1.7 million compared to the previous quarter, and had US$145 million cash on hand as of September 30, 2025 [4]. Operational Highlights - Mesoblast has onboarded 40 transplant centers since the product launch and identified 45 priority transplant centers that account for approximately 80% of U.S. pediatric transplants [4]. - Over 260 million U.S. lives are insured by commercial and government payers for Ryoncil, with federal Medicaid coverage in place [4]. - The company established a patient access hub, MyMesoblast™, to assist patients with insurance coverage and access to Ryoncil [4]. Regulatory and Development Updates - A specific J-Code (J3402) was assigned to Ryoncil by CMS, effective October 1, 2025, facilitating easier billing and reimbursement [4]. - Mesoblast plans to conduct a pivotal trial for Ryoncil in adults with severe steroid-refractory acute graft-versus-host disease (SR-aGvHD), aiming to extend its label from children to adults [5].

Market Overview - U.S. stock futures are lower, with Dow futures dropping over 200 points on Friday [1] Company-Specific Movements - Bitfarms Ltd (NASDAQ:BITF) shares fell 9.5% to $4.78 in pre-market trading after announcing the pricing of upsized $500 million convertible senior notes [1] - American Battery Technology Co (NASDAQ:ABAT) shares tumbled 19.8% to $4.55 in pre-market trading, following a 37% decline on Thursday due to the termination of a Department of Energy grant [3] - HIVE Digital Technologies Ltd (NASDAQ:HIVE) shares dipped 18.2% to $4.78 in pre-market trading after a 14% decline on Thursday [3] - Standard Lithium Ltd (NYSE:SLI) shares declined 17.3% to $4.45 in pre-market trading after pricing a $130 million underwritten public offering [3] - Almonty Industries Inc (NASDAQ:ALM) slipped 16.4% to $7.11 in pre-market trading after a 12% dip on Thursday [3] - Mesoblast Ltd (NASDAQ:MESO) declined 13.7% to $15.63 in pre-market trading [3] - Jumia Technologies AG – ADR (NYSE:JMIA) shares fell 13.2% to $10.31 in pre-market trading [3] - Terawulf Inc (NASDAQ:WULF) shares fell 13.1% to $12.05 after reporting the pricing of $3.2 billion of senior secured notes [3] - Diginex Ltd (NASDAQ:DGNX) shares slipped 13.1% to $14.45 after an 18% decline on Thursday [3] - Aeluma Inc (NASDAQ:ALMU) shares fell 12.1% to $16.46 in pre-market trading [3] - Compass Diversified Holdings (NYSE:CODI) declined 11.7% to $6.60 in pre-market trading after an 8% gain on Thursday [3] - Integra Resources Corp (NYSE:ITRG) fell 11.3% to $2.89 in pre-market trading [3] - Forward Industries Inc (NASDAQ:FORD) fell 10.8% to $22.00 in pre-market trading [3] - Bruker Corp (NASDAQ:BRKR) declined 10.3% to $34.25 in pre-market trading [3] - Inter & Co Inc (NASDAQ:INTR) fell 10% to $8.04 in pre-market trading [3] - Hut 8 Corp (NASDAQ:HUT) fell 8.5% to $44.59 in pre-market trading after a 10% dip on Thursday [3] - Bitdeer Technologies Group (NASDAQ:BTDR) fell 8.2% to $23.75 in pre-market trading [3] - CleanSpark Inc (NASDAQ:CLSK) fell 7.5% to $18.49 in pre-market trading [3] - Kratos Defense & Security Solutions Inc (NASDAQ:KTOS) fell 5.3% to $83.96 in pre-market trading [3]

Market Overview - U.S. stock futures are lower, with Dow futures dropping over 200 points on Friday [1] Company-Specific Movements - Bitfarms Ltd (NASDAQ:BITF) shares fell 9.5% to $4.78 in pre-market trading after announcing the pricing of upsized $500 million convertible senior notes [1] - American Battery Technology Co (NASDAQ:ABAT) shares tumbled 19.8% to $4.55 in pre-market trading, following a 37% decline on Thursday due to the termination of a Department of Energy grant [3] - HIVE Digital Technologies Ltd (NASDAQ:HIVE) shares dipped 18.2% to $4.78 in pre-market trading after a 14% decline on Thursday [3] - Standard Lithium Ltd (NYSE:SLI) shares declined 17.3% to $4.45 in pre-market trading after pricing a $130 million underwritten public offering [3] - Almonty Industries Inc (NASDAQ:ALM) slipped 16.4% to $7.11 in pre-market trading after a 12% dip on Thursday [3] - Mesoblast Ltd (NASDAQ:MESO) declined 13.7% to $15.63 in pre-market trading [3] - Jumia Technologies AG – ADR (NYSE:JMIA) shares fell 13.2% to $10.31 in pre-market trading [3] - Terawulf Inc (NASDAQ:WULF) shares fell 13.1% to $12.05 after reporting the pricing of $3.2 billion of senior secured notes [3] - Diginex Ltd (NASDAQ:DGNX) shares slipped 13.1% to $14.45 after an 18% decline on Thursday [3] - Aeluma Inc (NASDAQ:ALMU) shares fell 12.1% to $16.46 in pre-market trading [3] - Compass Diversified Holdings (NYSE:CODI) declined 11.7% to $6.60 in pre-market trading after an 8% gain on Thursday [3] - Integra Resources Corp (NYSE:ITRG) fell 11.3% to $2.89 in pre-market trading [3] - Forward Industries Inc (NASDAQ:FORD) fell 10.8% to $22.00 in pre-market trading [3] - Bruker Corp (NASDAQ:BRKR) declined 10.3% to $34.25 in pre-market trading [3] - Inter & Co Inc (NASDAQ:INTR) fell 10% to $8.04 in pre-market trading [3] - Hut 8 Corp (NASDAQ:HUT) fell 8.5% to $44.59 after a 10% dip on Thursday [3] - Bitdeer Technologies Group (NASDAQ:BTDR) fell 8.2% to $23.75 in pre-market trading [3] - CleanSpark Inc (NASDAQ:CLSK) fell 7.5% to $18.49 in pre-market trading [3] - Kratos Defense & Security Solutions Inc (NASDAQ:KTOS) fell 5.3% to $83.96 in pre-market trading [3]

Group 1: CSX Corp Performance - CSX Corp reported third-quarter revenue of $3.59 billion, exceeding analyst estimates of $3.58 billion [1] - The company achieved adjusted earnings of 44 cents per share, surpassing analyst expectations of 43 cents per share [1] - Following the earnings report, CSX shares increased by 4.2% to $37.51 in pre-market trading [1] Group 2: Other Stocks in Pre-Market Trading - Artiva Biotherapeutics Inc gained 98.6% to $5.50 after receiving FDA Fast Track Designation for AlloNK [4] - Safe & Green Holdings Corp surged 38.8% to $4.27 after completing Phase 1 of its intelligent wellsite monitoring system [4] - Kezar Life Sciences Inc rose 36% to $5.67 following a regulatory update on its Zetomipzomib program [4] - INVO Fertility Inc tumbled 34.6% to $0.92 after a significant rise of over 85% the previous day [4] - American Battery Technology Co shares dipped 19.8% to $4.55 after a 37% decline on Thursday due to the termination of a grant by the Department of Energy [4]