Mesoblast Limited American Depositary Shares - MESO STOCK NEWS

Mesoblast Limited (NASDAQ: MESO) has provided an operational and financial report for Q2 FY2022, highlighting steps towards the resubmission of its Biologics License Application (BLA) for remestemcel-L to treat steroid-refractory acute graft versus host disease (SR-aGVHD) in children. Key operational achievements include FDA meetings to clarify potency and manufacturing controls. Financially, the company reported $3.5 million in revenues, with significant cash reserves of $94.8 million. The Q2 cash usage was reduced by 38% compared to the previous year's quarter, indicating improved financial management.

Mesoblast Limited (Nasdaq: MESO; ASX: MSB) will participate in the Edison Group’s Open House Event from January 25-27, 2022. Focusing on numerous companies in the Pharmaceuticals & Drug Discovery sector, Mesoblast's presentations will be available for streaming starting from 8am GMT on January 25. Attendance is free, and registration can be completed through the provided link. The event showcases Mesoblast's innovative allogeneic cellular medicines aimed at treating severe inflammatory diseases, leveraging proprietary technology platforms.

Mesoblast Limited (NASDAQ: MESO) reported significant 36-month follow-up results from its Phase 3 trial for rexlemestrocel-L in chronic low back pain (CLBP) associated with degenerative disc disease. At the 2022 Biotech Showcase, results showed durable pain reduction through three years, especially in patients with shorter CLBP duration. Notably, 28% of opioid users in the treatment group ceased opioid use compared to 8% in controls. Plans for an additional US Phase 3 trial were confirmed following FDA feedback, focusing on pain reduction and functional improvement as primary endpoints.

Mesoblast Limited (Nasdaq: MESO) recently met with the FDA's Office of Tissues and Advanced Therapies (OTAT) to discuss the potency assay and chemistry, manufacturing, and controls (CMC) issues related to remestemcel-L for treating steroid-refractory acute graft versus host disease (SR-aGVHD) in children. OTAT found Mesoblast's approach to CMC acceptable and endorsed the in vitro immunomodulatory activity as a relevant quality attribute. The company has generated new data linking this activity to clinical outcomes, which will be submitted for the Biologics License Application resubmission.

Mesoblast Limited (NASDAQ: MESO) announced positive feedback from the FDA regarding its Phase 3 program for rexlemestrocel-L, aimed at treating chronic low back pain (CLBP) due to degenerative disc disease. The company plans an additional US Phase 3 trial, incorporating EU subjects, with pain reduction at 12 months as the primary endpoint. Successful outcomes could lead to milestone payments up to $112.5 million and cumulative payments potentially reaching $1 billion. The therapy aims to reduce opioid usage in a population heavily reliant on opioids for CLBP treatment.

Mesoblast Limited (NASDAQ: MESO) announced the termination of its agreement with Novartis, prior to closing. Despite missing the primary endpoint in its COVID-19 ARDS trial, Mesoblast identified a mortality reduction in patients under 65, prompting plans to seek emergency use authorization for remestemcel-L. The company aims to initiate a pivotal Phase 3 trial to support this effort. With ongoing concerns over COVID-19 variants, Mesoblast sees a significant commercial opportunity in treating ARDS, which continues to be a critical health issue.

Mesoblast Limited (Nasdaq: MESO) announced new findings from the DREAM-HF Phase 3 trial, focusing on the benefits of rexlemestrocel-L for high-risk patients with chronic heart failure and low ejection fraction (HFrEF). The trial revealed a 37% reduction in major adverse cardiovascular events (MACE) in patients with diabetes and/or myocardial ischemia. The FDA confirmed that such reductions in cardiovascular mortality are clinically meaningful, and Mesoblast plans to submit new analyses to the FDA to explore pathways for potential approval.

Mesoblast reported operational and financial results for Q1 FY2022, ending September 30, 2021. The company secured a strategic financing partnership with Oaktree Capital, expanding its senior debt facility by US$90 million. Cash on hand reached US$116.0 million, while revenues increased to US$3.6 million, boosted by a 90% rise in royalties from TEMCELL® HS Inj.1 in Japan. Loss after tax improved to US$22.6 million, down from US$24.5 million. Mesoblast also discussed potential FDA pathways for remestemcel-L and rexlemestrocel-L, focusing on treatments for SR-aGVHD and heart failure.

Mesoblast Limited (Nasdaq: MESO) will host a webcast on November 23, 2021, at 5:00 PM EST to discuss its operational highlights and financial results for the first quarter ending September 30, 2021. The company is recognized for its innovative allogeneic cellular medicines targeting severe inflammatory diseases. Mesoblast's product development includes remestemcel-L for acute graft versus host disease and rexlemestrocel-L for chronic heart failure. The archived webcast will be available on their investor page following the event.