Mesoblast’s US $40 Million Raise Oversubscribed As Its Pipeline Of Late-Phase Regenerative Drugs Continues To Progress

Published: Sep 28, 2017

Mesoblast, a world leader in cell-based regenerative medicine, was oversubscribed and enjoyed the support of its main shareholder on its recent raise of US $40 million. The company now has more than $80 million in cash which it will use to complete its Phase III trials in advanced chronic heart failure, acute graft versus host disease (aGVHD), and chronic low back pain.

Mesoblast has already obtained regulatory approval for its aGVHD treatment, MSC-100-IV, in Japan where its local partner, JCR pharmaceuticals, has launched the treatment for children and adults. The FDA has also granted the treatment a Fast Track designation to improve overall response rate in children with steroid refractory aGVHD. Regarding the Phase III program for its treatment for chronic lower back pain in degenerative disk disease, MPC-06-ID, Mesoblast is in alignment with the FDA, and has received confirmation that the trial’s primary endpoint is acceptable for product approval.

The company has also already enrolled 400 patients into its 600-patient Phase III trial for its cell therapy, MPC-150-IM, to treat moderate/severe advanced chronic heart failure. A further 159-patient randomized, placebo-controlled Phase IIb trial, funded by the National Institutes of Health (NIH) and the Canadian Institutes for Health Research (CIHR), evaluating MPC-150-IM in end-stage heart failure patients with left ventricular assist devices (LVAD) is also underway.

Mesoblast’s cell therapy technology uses proprietary mesenchymal lineage adult stem cells (MLCs), as opposed to embryonic stem cells, which are found in multiple tissues where they play vital roles in maintaining tissue health. MLCs are rare cells found around blood vessels that respond to signals associated with tissue damage. They secrete mediators and growth factors which promote tissue repair and modulate immune responses. Mesenchymal lineage adult stem cells can be sourced from young healthy adult donors and administered to thousands of patients without any material immune response.

Chief Executive and founder of Mesoblast, Dr Silviu Itescu, commented on the successful fund raise, saying, “Mesoblast is at a pivotal stage in its development, and the newly invested capital will provide the Company with balance sheet flexibility to achieve our near-term objectives, particularly the completion of our phase III trials in advanced chronic heart failure, aGVD, and chronic lower back pain. We greatly appreciate the continued support from our global institutional shareholders, and I am pleased to have invested alongside them.”

About Mesoblast

Mesoblast is a world leader in regenerative medicine, and develops innovative cellular medicines. It has established one of the industry’s most clinically advanced and diverse portfolio of cell-based products with three programs in active Phase III clinical studies.

Its lead product candidates under investigation include:

•?MPC-150-IM for chronic heart failure
•?MPC-06-ID for chronic low back pain due to disc degeneration
•?MSC-100-IV for acute graft versus host disease
•?MPC-300-IV for biologic refractory rheumatoid arthritis and diabetic nephropathy

The Company has used its proprietary technology platform, which is based on specialized cells known as mesenchymal lineage adult stem cells (MLCs), to establish a broad portfolio of late-stage product candidates. These allogeneic, ‘off-the-shelf’ cell product candidates target advanced stages of diseases with high, unmet medical needs including, cardiovascular diseases, immune-mediated and inflammatory conditions, spine orthopaedic disorders, and oncology and haematology diseases.

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