Mesoblast Ltd.

Mesoblast Ltd. is a clinical development company leveraging its proprietary core adult stem cell technologies, which include the Mesenchymal Precursor Cell (MPC) and culture-expanded Mesenchymal Stem Cell (MSC) platform technologies, Dental Pulp Stem Cells and expanded Hematopoietic Stem Cells. The company's cardiovascular and neurologic product pipeline is being developed in partnership with Teva Pharmaceutical Industries Ltd. Mesoblast Ltd's subsidiaries include Mesoblast Inc., Mesoblast International SA, Mesoblast Australia Pty Ltd and Mesoblast UK Ltd.

Expert Comments:

Katherine Genis, Edison Investment Research (1/25/16)
"As a leader in stem cell technologies, Mesoblast Ltd. continues to make good pipeline progress, nearing market readiness for its mesenchymal-based treatments in multiple indications. The company has received its first product approval for Temcell in acute graft versus host disease in Japan; Phase 3 programs for further lead products in congestive heart failure and lower back pain are moving forward."

Jason Kolbert, Maxim Group (1/11/16)
"Mesoblast Ltd.'s ongoing Phase 3 program will be revised. . .we view these revisions as very positive, as the interim analysis at 50% HF-MACE events will test for superiority. If that happens, we could see a fast track pathway to the global marketplace emerge."

Jason Kolbert, Maxim Group (12/31/15)
"The net result of our model revisions is a new Mesoblast Ltd. target of $18/share. . .in 2016, we are closely watching the company's degenerative disc disease (back pain) trial. We expect that the trial may enroll rapidly, as did the Phase 2 trial, targeting Q3/16 for complete enrollment. . .Mesoblast also expects to announce topline results from the first cohort in the Phase 2 trial in biologic-refractory rheumatoid arthritis."

Kevin DeGeeter, Ladenburg Thalmann (12/17/15)
"On Dec. 16, Mesoblast Ltd. released fiscal Q1/16 financial results and provided a corporate update including 1) reiteration of plans to complete interim analysis for Phase 3 studies in heart failure (calendar Q1/16) and U.S. Phase 3 pediatric acute graft-versus-host disease (aGVHD) in calendar H2/16, and 2) plans to trim operating cash burn by 20–25% through reduction in overhead and reduced spending on tier 2 R&D programs in Crohn's disease cardiac ischemia, spinal fusion and bone marrow transplantation. Importantly, following restructuring we expect the company to have adequate cash to fund operation into fiscal Q4/17."

Kevin DeGeeter, Ladenburg Thalmann (12/8/15)
"We hosted Duke University Professor Joanne Kurtzberg, a key opinion leader in pediatric hematology, for a discussion of current treatment options for steroid refractory pediatric acute graft-versus-host disease (aGVHD) and the outlook for new therapies, include Mesoblast Ltd.'s mesenchymal stem cell-based program. Dr. Kurtzberg noted that given the absence of effective treatents and one-year survival as low as 10-15% for pediatric aGVHD patients, any product with modest positive overall response rate at lower bound of a confidence interval would likely be adopted by most pediatric hematologists. . .and used off label in adult patients if the product is approved in the U.S."

Kevin DeGeeter, Ladenburg Thalmann (12/4/15)
"Mesoblast Ltd. expects to release interim data in calendar Q3/16 from the Phase 3 program for treatment of steroid-refractory pediatric acute graft-versus-host disease, which could enable a biologics license application filing as early as calendar H2/17. Based on our analysis of a large 160-patient pediatric expanded access study, which demonstrated a 64% overall response rate (ORR) at day 28 that correlated with survival at day 100 post infusion, we believe the Phase 3 study is likely to meet its primary endpoint of an improvement in ORR at 28 days."

More Expert Comments

Experts Following This Company

Kevin DeGeeter, Director, Equity Research Analyst – Ladenburg Thalmann
Katherine Genis, Analyst – Edison Investment Research
Jason Kolbert, Senior Analyst – Maxim Group
Jason McCarthy, Analyst – Maxim Group
Henry McCusker, Founder and Director of Research – Scimitar Equity
Henry McCusker RegMed Investors
Alain Vertes, Managing Director – NxR Biotechnologies GmbH
Marcel Wijma, Analyst – The Daily Molecule (Van Leeuwenhoeck Research), Van Leeuwenhoeck Research

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