Regenerative medicine company, Mesoblast Limited (ASX: MSB) recently highlighted the commercial and development plans for its lead cellular therapies at the first day of Biotech Showcase 2019 which is being held this week in San Francisco, California. Following this news, the share price of the company increased by 1.866 percent as on 8 January 2019.
At the Biotech Showcase, the Chief Executive of Mesoblast Dr. Silviu Itescu talked about the successful completion of the company’s Phase 3 trial in steroid-refractory acute graft versus host disease (aGVHD). He also told the meeting attendees that 2019 will be a crucial year for the Mesoblast Limited’s heart failure product candidate Revascor. Dr. Silviu Itescu told that the company will meet U.S. Food and Drug Administration to discuss the approval pathway for Revascor in patients with end-stage heart failure and a left ventricular assist device.
The meeting attendees were also informed about the clinically meaningful outcomes achieved by the company in the trial of Revascor (MPC-150-IM) which helped in the reducing of gastrointestinal bleeding and related hospitalizations in the patients. The Phase 3 trial of Revascor has recently completed the recruitment of around 570 patients which is an important step forward in the company’s objective to treat the patients with progressive heart failure effectively. Further, the completion of the Phase 3 trial of Revascor is a tremendous commercial opportunity for the company.
Dr. Silviu Itescu also informed that the company is planning to work closely with the U.S. Food and Drug Administration to submit a rolling Biologics License Application for use of remestemcel-L which is used for treating children who are suffering from steroid-refractory acute graft versus host disease (aGVHD). Further, the company will also work on the market access and commercialization strategy of remestemcel-L.
In the first quarter of 2019, the company earned a revenue of US$11.6 million and operating cash outflows of US$0.8 million. The Research and Development expenses of the company were US$18.5mn in Q1 FY2019 which is US$3.1 million (20%) higher than Q1 FY2018. The company recognized Finance Costs of US$2.6 million in interest expenses and incurred manufacturing expenses of US$4.3 million in Q1 2019. The company’s net loss attributable to ordinary shareholders was US$19.5mn in Q1 FY2019.
In the first quarter of 2019, the company expanded its partnership with JCR Pharmaceuticals Co. Ltd (JCR) to treat wound healing in epidermolysis bullosa (EB) and also completed its transaction with Tasly for establishing a strategic cardiovascular partnership in China.
Meanwhile, in the last six months, the share price of MSB decreased by 15.72 percent as on 7 January 2019. MSB’s shares traded at $1.365 with a market capitalization of circa $668.16 million as on 8 January 2019 (AEST 4:00 PM).