Mesoblast (MESO)
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Quantum Computing, Mesoblast And Other Big Stocks Moving Lower In Monday's Pre-Market Session
Benzinga· 2025-10-06 12:09
Market Overview - U.S. stock futures are higher, with Dow futures gaining approximately 100 points [1] Quantum Computing Inc. - Quantum Computing Inc. (NASDAQ:QUBT) raised $750 million from institutional investors through a market-priced private placement led by top shareholders [1] - Shares of Quantum Computing fell sharply by 11.7% to $21.70 in pre-market trading [1] Other Stocks in Pre-Market Trading - Rich Sparkle Holdings Ltd (NASDAQ:ANPA) dropped 15% to $22.10 after a 10% decline on Friday [3] - Nordic American Tankers Ltd (NYSE:NAT) decreased by 7.8% to $3.07 [3] - Smurfit WestRock PLC (NYSE:SW) fell 5.8% to $39.54 [3] - Mesoblast Ltd (NASDAQ:MESO) declined 5.2% to $17.45, despite an 8% gain on Friday following the announcement of Ryoncil receiving a J-Code from Medicare & Medicaid Services [3] - Invesco Mortgage Capital Inc (NYSE:IVR) decreased by 4.4% to $7.42 [3] - Inventiva ADR (NASDAQ:IVA) fell 4.2% to $6.26 after appointing Andrew Obenshain as CEO [3] - International Paper Co (NYSE:IP) dropped 4.2% to $45.21 ahead of its third-quarter earnings release on October 30 [3] - Lufax Holding Ltd – ADR (NYSE:LU) fell 3.7% to $3.85 after an 8% decline on Friday [3] - Larimar Therapeutics Inc (NASDAQ:LRMR) decreased by 3.3% to $4.71 after a 14% jump on Friday [3]
White Mountains Insurance, Rumble, Mesoblast And Other Big Stocks Moving Higher On Friday - Diginex (NASDAQ:DGNX), Cipher Mining (NASDAQ:CIFR)
Benzinga· 2025-10-03 14:36
Group 1 - U.S. stocks experienced an upward trend, with the Dow Jones index increasing by over 350 points on Friday [1] - White Mountains Insurance Group announced plans to sell a controlling interest in its technology-driven homeowners' insurance distribution platform, Bamboo, to CVC Capital Partners, leading to a significant rise in its stock price [1][2] - The deal values Bamboo at $1.75 billion, and the company specializes in data-enabled underwriting and distribution for the residential property market in California and Texas [2] Group 2 - White Mountains Insurance Group shares surged by 9.2%, reaching $1,817.83 on Friday following the announcement of the Bamboo deal [2] - Other notable stock gains included Anbio Biotechnology, which rose by 69.6% to $43.07, and Lithium Americas Corp., which increased by 29.1% to $8.85 [4] - USA Rare Earth, Inc. shares climbed 21.4% to $27.56 amid reports of discussions with the White House [4]
Ryoncil® Receives J-Code From Medicare & Medicaid Services (CMS) Facilitating Reimbursement and Broader Patient Access
Globenewswire· 2025-10-03 01:04
Core Points - Mesoblast Limited announced that the Healthcare Common Procedure Coding System (HCPCS) J-Code J3402 for Ryoncil became active for billing and reimbursement on October 1, 2025, marking a significant milestone for the product [1][2] - The permanent J-Code provides a standardized billing pathway for Ryoncil, facilitating reimbursement and improving patient access [2] - Ryoncil is the first FDA-approved mesenchymal stromal cell (MSC) product for any indication and is specifically approved for children under 12 with steroid-refractory acute graft-versus-host disease (SR-aGvHD) [3][6] Company Overview - Mesoblast is a leader in developing allogeneic cellular medicines for severe inflammatory conditions, utilizing a proprietary mesenchymal lineage cell therapy technology platform [5] - The company is committed to developing additional cell therapies for various indications, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, as well as heart failure and chronic low back pain [7] - Mesoblast has a strong intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection expected to extend through at least 2041 in major markets [8]
Mesoblast Limited (MESO)’s Ryoncil® Gains U.S.-Origin Status, Avoids Import Tariffs
Yahoo Finance· 2025-10-01 17:46
Group 1 - Mesoblast Limited (NASDAQ:MESO) is a leader in developing allogeneic, off-the-shelf cellular medicines for inflammatory diseases, targeting severe conditions by modulating immune responses and promoting tissue repair [2] - The company's lead product, Ryoncil® (remestemcel-L), is the first FDA-approved allogeneic mesenchymal stromal cell therapy for pediatric patients with steroid-refractory acute graft versus host disease (SR-aGvHD) [2] - In late September 2025, Mesoblast reaffirmed that all its cell therapy products, including Ryoncil®, are manufactured from U.S. donors, which exempts them from pharmaceutical import tariffs, providing a commercial advantage [3] Group 2 - Mesoblast is advancing the commercial launch of Ryoncil® and progressing regulatory pathways for other therapies, including a Biologic License Application for Revascor® aimed at treating ischemic heart failure, which is under FDA review [4] - The company is also expanding the development of rexlemestrocel-L for chronic conditions such as heart failure and low back pain [4]
Mesoblast Cell Therapy Products are Designated U.S. Origin and Not Subject to Tariffs
Globenewswire· 2025-09-26 05:49
Core Insights - Mesoblast Limited is a global leader in allogeneic cellular medicines for inflammatory diseases, emphasizing that its products are manufactured from U.S. donors and are not subject to tariffs on imported pharmaceutical products [1][3][6] Company Overview - Mesoblast specializes in developing allogeneic (off-the-shelf) cellular medicines aimed at treating severe inflammatory conditions, utilizing proprietary mesenchymal lineage cell therapy technology [4][6] - The company has a strong intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection expected to last until at least 2041 in major markets [7] Product Information - Ryoncil® (remestemcel-L) is the only FDA-approved allogeneic mesenchymal stromal cell therapy for steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients aged 2 months and older [2][5] - The company is developing Ryoncil® for additional indications, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, while rexlemestrocel-L is being developed for heart failure and chronic low back pain [6] Manufacturing and Distribution - Mesoblast's proprietary manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf cellular medicines, which are planned to be readily available to patients worldwide [8] - The company operates in Australia, the United States, and Singapore, and is listed on both the Australian Securities Exchange and Nasdaq [9]
Mesoblast Cell Therapy Products are Designated U.S. Origin and Not Subject to Tariffs
Globenewswire· 2025-09-26 05:49
Core Insights - Mesoblast Limited is a global leader in allogeneic cellular medicines for inflammatory diseases, emphasizing that its products are manufactured from U.S. donors and are not subject to tariffs on imported pharmaceutical products [1][2]. Company Overview - Mesoblast specializes in developing allogeneic (off-the-shelf) cellular medicines aimed at treating severe and life-threatening inflammatory conditions, utilizing proprietary mesenchymal lineage cell therapy technology [4]. - The company has a strong intellectual property portfolio with over 1,000 granted patents or applications, providing commercial protection expected to last until at least 2041 in major markets [7]. Product Information - Ryoncil (remestemcel-L) is the only FDA-approved allogeneic mesenchymal stromal cell therapy for any indication, specifically for pediatric patients with steroid-refractory acute graft versus host disease (SR-aGvHD) [2][5]. - Ryoncil is also being developed for additional inflammatory diseases, including SR-aGvHD in adults and biologic-resistant inflammatory bowel disease, while another product, rexlemestrocel-L, targets heart failure and chronic low back pain [6]. Manufacturing and Distribution - Mesoblast's manufacturing processes yield industrial-scale, cryopreserved, off-the-shelf cellular medicines, ensuring availability to patients worldwide [8]. - The company operates in Australia, the United States, and Singapore, and is listed on both the Australian Securities Exchange and Nasdaq [9].
Successful Commercial Launch of Ryoncil® Highlighted at Global Healthcare Conferences
Globenewswire· 2025-09-15 01:18
Core Insights - Mesoblast Limited has successfully launched Ryoncil, the first FDA-approved mesenchymal stromal cell (MSC) therapy for steroid-refractory acute graft versus host disease (SR-aGvHD) in pediatric patients [1][5] - The company aims to expand Ryoncil's applications to adult SR-aGvHD and inflammatory bowel disease (IBD), alongside advancing its second-generation product, Rexlemestrocel-L [3][6] Company Overview - Mesoblast is a leader in developing allogeneic cellular medicines targeting severe inflammatory conditions, utilizing a proprietary mesenchymal lineage cell therapy technology platform [4] - The company has a robust intellectual property portfolio with over 1,000 patents or applications, providing commercial protection until at least 2041 in major markets [7] Product Development - Ryoncil is currently being developed for additional indications, including adult SR-aGvHD and biologic-resistant IBD, while Rexlemestrocel-L is focused on heart failure and chronic low back pain [6] - The company is actively working to onboard new sites and increase the usage of Ryoncil [2] Manufacturing and Distribution - Mesoblast's proprietary manufacturing processes allow for industrial-scale production of cryopreserved, off-the-shelf cellular medicines, ensuring availability for patients worldwide [8]
Mesoblast Enters Into Option To Issue US$50 Million Convertible Notes
Globenewswire· 2025-09-04 01:47
Core Viewpoint - Mesoblast Limited has announced a plan to issue up to US$50 million in unsecured convertible notes to support its capital structure and ongoing pipeline growth opportunities, subject to shareholder approval [1][2]. Group 1: Convertible Notes Details - The company may issue the convertible notes in tranches of US$10 million, with a maturity date of 5 years after the first issuance [2]. - The conversion price is set at US$16.25 per ADR, which is a 126% premium over the last closing price on Nasdaq and a 29% premium on the ASX [3]. - The notes will carry a coupon of 5% per annum on the face value [3]. Group 2: Investor Considerations - Investors will receive a commitment fee of US$100,000 and warrants for 2 million ordinary shares upon entering the agreement, with additional warrants for 3 million shares if the option is exercised [4]. - The warrants will have the same exercise price as the conversion price and a maturity date of 4 years from the issuance date [4]. Group 3: Company Overview - Mesoblast is a leader in developing allogeneic cellular medicines for severe inflammatory conditions, utilizing a proprietary mesenchymal lineage cell therapy technology platform [6]. - The company has FDA-approved therapies, including Ryoncil for treating steroid-refractory acute graft versus host disease in pediatric patients [7]. - Mesoblast is also developing additional therapies for various inflammatory diseases and has established commercial partnerships in multiple regions [8]. Group 4: Intellectual Property and Manufacturing - Mesoblast holds over 1,000 granted patents or applications related to its cell therapy technologies, providing commercial protection expected to last until at least 2041 in major markets [9]. - The company has proprietary manufacturing processes that yield industrial-scale, cryopreserved cellular medicines, ensuring availability to patients worldwide [10].
Mesoblast (MESO) - 2025 Q4 - Annual Report
2025-08-29 10:58
mesoblast Exhibit 99.2 Global Leader in Allogeneic Cellular Medicines for Inflammatory Diseases Financial Results and Operational Update for the Full Year Ended June 30, 2025 August 2025 ASX: MSB; Nasdag: MESO CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS this presentation includes forward-looking statements that relate to future events or our future financial performance and involve rids, uncertainties and other factors tha cesults, levels of activity, performance or activements to differ materially ...
Mesoblast (MESO) - 2025 Q4 - Annual Report
2025-08-29 10:22
Financial Performance - As of June 30, 2025, the company held total cash reserves of $161.6 million, with net cash usage for operating activities reported at $50.0 million for the year[534]. - Since the launch of Ryoncil in late March 2025, the company achieved net product sales of $11.3 million through June 30, 2025[534]. - Net cash outflows in operating activities increased by $1.5 million from $48.5 million in 2024 to $50.0 million in 2025, attributed to a decrease in cash inflows[536]. - The company reported net cash inflows from financing activities of $147.3 million for the year ended June 30, 2025, an increase of $107.1 million compared to the previous year[540]. - Revenue for FY2025 was US$17.2 million, representing a 191% increase compared to US$5.9 million in FY2024[620]. - The company reported a loss before income tax of US$101.8 million for FY2025, compared to US$88.1 million in FY2024[620]. Product Development and Regulatory Approvals - The company anticipates continued losses in the foreseeable future as it develops and seeks regulatory approvals for its cell-based product candidates, including Ryoncil[543]. - FDA approved Ryoncil in December 2024, marking it as the first mesenchymal stromal cell therapy approved in the U.S. for children aged 2 months and older with SR-aGvHD[572]. - Mesoblast aligned with the FDA on key items for filing a Biologics License Application for Revascor, targeting ischemic heart failure with reduced ejection fraction[575]. - The confirmatory Phase 3 trial of rexlemestrocel-L commenced, with 37 sites enrolling patients across the United States[625]. - The CHF program gained alignment with the US FDA in June 2025 for filing a BLA for Revascor, targeting patients with ischemic heart failure[626]. Executive Leadership and Governance - Joseph Swedish served as Chairman, President, and CEO of Anthem, Inc., growing membership by 4 million (11%) and increasing operating revenue by 39% to over $89 billion during his tenure[555]. - Dr. Eric Rose played a key role in obtaining FDA approval for TPOXX, securing contracts for 1.7 million courses valued at over $1 billion for the Strategic National Stockpile[560]. - Silviu Itescu has been CEO since 2011, with a background in stem cell biology and significant contributions to adult stem cell therapy[559]. - Andrew Chaponnel has 25 years of finance experience, including 13 years at Mesoblast, overseeing NASDAQ IPO and financial reporting[562]. - The board consists of seven members, including five non-executive directors and two executive directors[711]. Employee and Remuneration Policies - Approximately 97% of employees opted for stock options instead of cash for short-term incentives, conserving approximately $6.7 million in cash[576]. - The CEO's remuneration was adjusted, with the maximum short-term incentive increased from 50% to 100% of base salary, while long-term incentives were reduced from 200% to 100% of base salary[584]. - The total statutory remuneration for the CEO in FY25 was A$8,448,247, with 82% being performance-based remuneration[641]. - The total statutory remuneration for the CMO in FY25 was A$4,619,202, with 85% being performance-based remuneration[641]. - The company’s CEO and CMO voluntarily reduced their base salaries by 30% for a 12-month period ending August 31, 2025, in exchange for an option grant approved by shareholders[645]. Shareholder and Market Performance - Total Shareholder Return (TSR) for the year was 68%[575]. - The share price of Mesoblast (ASX:MSB) closed at A$1.66 on June 30, 2025, up 88% from A$0.99 in 2024[620]. - Mesoblast raised US$160 million in January 2025 to strengthen its balance sheet for the commercial launch and ongoing R&D[621]. - The company was added to the Nasdaq Biotechnology Index in December 2024 as part of the annual reconstitution[622]. Risk Management and Compliance - The company has adopted a risk management policy to identify and control material risks associated with its business operations[722]. - The Audit and Risk Committee oversees various auditing and accounting matters, including the selection of independent accountants and the scope of annual audits[718]. - The company follows ASIC guidelines for rounding amounts in financial reports, rounding to the nearest thousand dollars or dollar[709]. - The auditor's independence declaration for the year ended June 30, 2025, is included in the annual report[708]. Employee Structure and Growth - As of June 30, 2025, the company had 81 employees globally, an increase from 73 in 2024, with 62% based in the United States[689]. - The breakdown of employees by category shows 41 in Research & Development, 2 in Commercial, 15 in Manufacturing, and 23 in Corporate[723]. - The majority of employees (27%) are based in Australia, where the corporate headquarters is located[691].