Mesoblast Limited American Depositary Shares - MESO STOCK NEWS

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.

Mesoblast Limited (NASDAQ: MESO) has refinanced its senior debt facility with a new US$90 million five-year agreement from Oaktree Capital Management. The first tranche of US$60 million was drawn to settle existing debt with Hercules Capital. The facility features a three-year interest-only period with a 9.75% annual interest rate. Oaktree will also receive 1,769,669 warrants at a 15% premium to the 30-day VWAP. Mesoblast aims to use this financing for commercial growth as it prepares to launch its first product in the US market.

Mesoblast Limited (Nasdaq: MESO) has successfully refinanced its senior debt with a new US$90 million facility from Oaktree Capital Management. The initial tranche of US$60 million has been drawn to repay existing debts, with an option to draw up to US$30 million before December 31, 2022. This facility includes a three-year interest-only period at a 9.75% rate, leading to principal amortization. Oaktree will also receive warrants to purchase 1,769,669 American Depositary Shares at US$7.26 each. Mesoblast aims to leverage this financing to advance its product commercialization in the U.S.

Mesoblast Limited (Nasdaq: MESO) announced positive results from a Phase 3 trial of rexlemestrocel-L for patients with chronic heart failure. The trial showed a 65% reduction in heart attacks or strokes and an 80% reduction in cardiovascular death among those with high systemic inflammation. The study highlights the potential of cell therapy to address inflammation in heart failure, a major health challenge. Despite these promising results, no reduction in hospitalization rates was observed. The findings were presented at the American Heart Association's annual conference.

Financial and Operational Highlights for Quarter Ended September 30, 2021

Mesoblast Limited (Nasdaq: MESO) reported notable growth in its revenues for the quarter, earning US$2.4 million from TEMCELL® HS Inj. royalties in Japan, marking a 22% increase from the previous quarter and a 90% increase year-over-year. The total net cash usage was US$19.6 million, with about 50% directed towards the remestemcel-L platform. Cash reserves stood at US$116 million. Key upcoming FDA discussions will focus on regulatory approval processes, and the company is collaborating with Novartis on the remestemcel-L treatment for ARDS.