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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.

The information provided below is from analysts, newsletters and other contributors. Please contact the company and visit its website before making an investment decision.

Expert Comments:

Kevin DeGeeter, Ladenburg Thalmann (12/12/14) "On Dec. 11, 2014, Mesoblast Ltd.'s partner for development of mesenchymal precursor cells for cardiovascular disease, Teva Pharmaceutical Industries Ltd., held an analyst meeting to provide an outlook for 2015, including an overview of research and development priorities. We believe the presentation significantly derisks development of Mesoblast's cardiovascular franchise and removes a potential overhang from the company's shares."

Katherine Genis, Edison Investment Research (11/24/14) "Mesoblast Ltd. plans to file in pediatric graft-versus-host-disease in 2016 in the U.S. Phase 3 trials started early this year for MPC-150-IM in congestive heart failure while Phase 3 trials for MPV-06-ID in low back pain are expected to start by 2014E. . .the company has also recently provided details to the market of its newly tiered product structure, whereby resources are being funneled into its key late-stage products."

Katherine Genis, Edison Investment Research (10/30/14) "Mesoblast Ltd.'s product pipeline continues to mature as key milestones are met. . .the company expects first commercial sales of its adult stem cell therapies from the potential launch of MSC-100-IV in Japan in graft-versus-host disease. . .Mesoblast maintains a strong balance sheet, ending FY/14 with cash of AU$196.4M. . .by the end of this year, the company should have five active programs in Phase 3 (two of which are partnered) and four in Phase 2 studies (one partnered). . .we have increased our valuation of Mesoblast to AU$3.16B from AU$2.85B."

The Life Sciences Report Interview with R. Lee Buckler (10/22/14) "The company that is potentially in the pole position in Japan at the moment, however, may be Mesoblast Ltd. The company inherited a relationship with Japan-based JCR Pharmaceuticals Co. Ltd. when, in 2013, it acquired the Prochymal (remestemcel-L or allogeneic, adult human mesenchymal stem cells) product portfolio from Osiris Therapeutics Inc. The Osiris/JCR partnership, which was put into place a number of years ago, had been stagnant until the reemergence of the Japanese market as an important one for the regenerative medicine sector. Now Mesoblast has "regenerated" that relationship, and announced on Oct. 1 that JCR would be filing a market approval application for Prochymal in Japan for the treatment of pediatric GvHD, following a similar approvals in Canada and New Zealand." More >

Jason Kolbert, Maxim Group (8/26/14) "Mesoblast Ltd. reported H1/14 results. The company spent approximately AU$81M and ended H1/14 with $196M on the balance sheet. . .we conclude that data, data, data are coming in 2015/2016, and we expect, based on robust Phase 2 trials, that the pivotal trials have a positive skew."

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Jason Kolbert, Maxim Group (6/19/14) "Mesoblast Ltd. reported positive topline efficacy results from a Phase 2 trial of mesenchymal precursor cells (MPCs) in patients with type 2 diabetes. . .it's early days and small numbers but the data sound really good. . .the company continues to execute on fundamentals and the data continue to build for a range of therapeutic effects of MPCs in the target indications."

Jason Zhang, Edison Investment Research (5/27/14) "Mesoblast Ltd. intends to initiate a Phase 3 trial of mesenchymal precursor cells in discogenic low back pain later this year, following the successful Phase 2 trial that reported in February. . .now a leading contender in the field, Mesoblast could have five active programs in Phase 3 (two partnered) and four in Phase 2 studies (one partnered) with nine clinical candidates by the end of this year. We expect CEP-41750 to become the leading stem cell therapy for congestive heart failure."

Kevin DeGeeter, Ladenburg Thalmann (4/29/14) "Mesoblast Ltd. expects to meet with the U.S. Food and Drug Administration (FDA) 'shortly' to discuss plans to submit a biologic license application based on existing clinical data, including data from an expanded access program. . .in our view, an update on the program is likely in June 2014 following distribution of written minutes from the FDA meeting. . .we reiterate our Buy rating with a $52 price target."

Jason Kolbert, Maxim Group (4/21/14) "Our analysis suggests that Mesoblast Ltd.'s current trial data, the partner commitments, the science, its credibility and the weight of supporting scientific published reports all support our belief that this technology can work. . .our current price target for the company is $14/share."

Jason Kolbert, Maxim Group (2/26/14) "Mesoblast Ltd. spent $67.6M ($20M acquisition related) and finished the year with $250M in cash on the balance sheet. . .the FDA has now cleared the pivotal trial for Revascor (MPCs) for chronic congestive heart failure. . .the company recently announced positive follow-up data from the 100-patient degenerative disc disease trial, which showed that a single injection of MPCs into degenerating intervertebral discs reduced low back pain and improved function for at least 12 months."

Kevin DeGeeter, Ladenburg Thalmann (2/26/14) "Mesoblast Ltd. reported better-than-expected H1/14 financial results and provided two important updates on its spine disease franchise, including its active partnership discussions for spinal fusion and plans to have an end-of-phase 2 meeting with the FDA regarding Revascor. . .both of these milestones could serve as material catalysts for the company's shares in 2014 and we believe many investors are overlooking the commercial opportunity for Mesoblast in spine disease. . .we reiterate our Buy rating."

Chris Kallos, Edison Investment Research (2/4/14) "Mesoblast Ltd. has reported positive results from its 100-patient, phase 2 trial of mesenchymal precursor cells in patients with chronic moderate-to-severe discogenic low back pain. The data show strong indications of sustained efficacy across a broad range of clinical and radiographic parameters and support a planned move into phase 3 studies."

Jason Kolbert, Maxim Group (1/30/14) "Mesoblast Ltd. reported positive 12-month follow-up data from the 100-patient degenerative disc disease trial. . .the data looks strong at 12 months across all composite primary endpoints. . . we would not be surprised, now post phase 2 results, to see a major device company partner with Mesoblast and commercialize this product. With that said, the timing, size and cost to run a single pivotal trial may be compelling, so that Mesoblast is under no pressure to prematurely partner."

Kevin DeGeeter, Ladenburg Thalmann (1/30/14) "Mesoblast Ltd. reported positive 12-month data from its phase 2 study of mesenchymal precursor cells in patients with chronic moderate to severe discogenic low back pain. The data demonstrated an impressive improvement in visual analog scale, which we view as the gold standard for pain studies. . .based on the strong phase 2 data we expect Mesoblast to initiate a phase 3 study in H2/14 with potential regulatory submission in H1/16."

Jason Kolbert, Maxim Group (1/27/14) "We expect to see followup data soon from Mesoblast Ltd.'s phase 2 degenerative disc disease (DDD) trial, extending the data set out to 12 months. This more complete data set should pave the way for a pivotal trial in DDD, which we believe has the potential to change the disease's treatment paradigm: cells versus steroids and pain medications."

The Life Sciences Report Interview with Jason Kolbert (12/17/13) "Mesoblast Ltd. and Teva Pharmaceutical Industries Ltd. are initiating a 1,700-patient phase 3 trial in chronic congestive heart failure (CHF) this month with Revascor. . .we know that six months from now, Mesoblast will be in multiple pivotal trials, in everything from spinal fusion and degenerative disk disease to CHF. We know that the company will be reporting phase 3 results in Crohn's disease using Prochymal (adult human mesenchymal stem cells), which it acquired from Osiris Therapeutics Inc. We know Mesoblast will report phase 2 data from its STEMI trial, which Teva has expanded and which is being run in Australia. Data drives valuation. . .

On the immunology side, Mesoblast is clearly making a huge bet with the acquisition of Prochymal. The company is saying Prochymal works, and that if it runs the proper clinical trials, Prochymal is an approvable product in the U.S. for graft-versus-host disease (GvHD). . .we'd love to see Mesoblast launch a U.S. clinical trial with Prochymal in GvHD, where an approved therapy is so desperately needed." More >

The Life Sciences Report Interview with Reni Benjamin (12/12/13) "In the cell therapy space, Mesoblast Ltd. is the 800-pound gorilla in terms of market cap. But we think investors should realize that there is a significant amount of pharmaceutical and investor interest out there. . .the company has a 1,700-patient phase 3 study in progress, evaluating its lead compound, Revascor (mesenchymal precursor cells), in congestive heart failure—clearly a big market. The company has significant cash, and I believe the trial has already begun enrolling worldwide." More >

Jason Kolbert, Maxim Group (12/4/13) "Mesoblast Ltd. announced topline results from its phase 2 trial of its allogeneic stem cell therapy in type 2 diabetic patients. . .this is yet another example, of data, that these cells are active, safe and, in the right setting, effective."

Kevin DeGeeter, Ladenburg Thalmann (12/4/13) "On Dec. 3, 2013, Mesoblast Ltd. disclosed positive topline results from a phase 2 study of the company's mesenchymal precursor cells in patients with type 2 diabetes. Importantly, the data significantly increase our confidence in a positive outcome for Mesoblast's ongoing phase 2 study in a related disorder, diabetic nephropathy."

Michael Aitkenhead, Edison Investment Research (11/26/13) "Mesoblast Ltd.'s multi-indication pipeline is targeting chronic diseases affecting large populations. Indications with positive phase 2 clinical data include congestive heart failure (Revascor), spinal fusion (NeoFuse), intervertebral disc repair, Crohn's disease, graft versus host disease and bone marrow transplantation. . .major alliances, Teva Pharmaceutical Industries Ltd., Lonza Group AG, JCR Pharmaceuticals Co. Ltd., reduce execution risk for Mesoblast's late-stage pipeline."

Kevin DeGeeter, Ladenburg Thalmann (11/21/13) "The Japanese legislature passed a bill endorsing an abbreviated pathway to approval for stem cell therapies based on demonstration of safety and limited efficacy studies. . .we expect Mesoblast Ltd. and other diversified stem cell companies to use an abbreviated pathway in Japan to explore potential commercialization of niche indications with more flexible reimbursement models."

Jason Kolbert, Maxim Group (11/20/13) "All investors should understand that Mesoblast Ltd.'s newly published data in cardiac patients using left ventricular assist devices, which demonstrated that allogeneic stem cells (Mesoblast's mesenchymal precursor cells) improved cardiac function when injected into these patients' hearts, is another important data bite along the road to improving survival. We believe cell therapy can improve survival outcomes. . .we see the company as the undisputed leader in the congestive heart failure space."

Jason Kolbert, Maxim Group (11/18/13) "Mesoblast Ltd. last week announced that preclinical data utilizing its mesenchymal precursor cells (MPCs) in a rat stroke model could improve functional recovery of the animals. . .the trial results showed that a single intravenous injection of human MPCs significantly enhanced sensorimotor recovery when administered up to seven days after an ischemic stroke in rats. Additionally, in a sub-study, MPCs increased neuronal activity and reduced the volume of infarct tissue."

Kevin DeGeeter, Ladenburg Thalmann (11/11/13) "At the Neuroscience 2013 conference Mesoblast Ltd. presented early but very intriguing data in a stroke model. We believe there are two notable findings from the preclinical study, one clinical in terms of stroke patients and the other pertaining to the company's mesenchymal precursor cell, that could prove to be extremely significant if replicated in future study. . .we reiterate our Buy rating and US$52 price target."

Jason Kolbert, Maxim Group (10/31/13) "The FDA has approved Mesoblast Ltd. commencing a phase 3 trial in patients with chronic congestive heart failure using its proprietary mesenchymal precursor cells. . .in the company's completed phase 2 trial, the composite endpoints of cardiac mortality and heart failure hospitalization were reduced from 20% in controls to 0% over 18 months of follow-up by a single intracardiac injection of the highest 150M cell dose of Revascor."

Kevin DeGeeter, Ladenburg Thalmann (10/31/13) "On Oct. 31, 2013, Mesoblast Ltd. announced the U.S. Food and Drug Administration (FDA) had cleared the investigational new drug application for initiating a phase 3 study for its mesenchymal precursor cell technology for treatment of chronic congestive heart failure. . .the study contains two interim analyses, which we believe may offer an opportunity for the company to explore avenues for fast track designation from the FDA in roughly 24 months and a path to accelerated approval. . .we reiterate our Buy rating."

Jason Kolbert, Maxim Group (10/28/13) "Mesoblast Ltd. announced that partner JCR Pharmaceuticals Co. Ltd. intends to file Prochymal for the treatment of steroid-refractory graft-versus-host disease in children and adults following bone marrow transplantation. . .Japan represents a strategic milestone for Mesoblast. . .through the acquisition of Prochymal, Mesoblast now has access to an experienced cell therapy partner 'on the ground' in Japan—a partner that is about to file the country's first cell therapy product. We see great strategic value in this news."

Henry McCusker, Scimitar Equity (10/23/13) "Mesoblast Ltd. is now expanding the focus of its oncology therapeutic area beyond the field of bone marrow transplants and the treatment of its major complication, acute graft-versus-host disease. If this complex cell plus transgene approach is successful for lung cancers, the technology will be explored for the treatment of other cancers."

Jason Kolbert, Maxim Group (10/23/13) "Mesoblast Ltd. just announced a three-way equal deal with Ziopharm Oncology Inc. and Intrexon Corp. . .to codevelop complex transgene enabled cell-based treatments for oncology applications. . .Mesoblast is the undisputed leader in the cell therapy space. The entrée into oncology is exciting."

Michael Aitkenhead, Edison Investment Research (10/21/13) "Mesoblast Ltd.'s acquisition of Osiris Therapeutics Inc.'s culture-expanded mesenchymal stem cells (MSC) business consolidates its position as the leading MSC development company. For a relatively modest initial consideration of US$50M, Osiris adds a complementary stem cell platform, two phase 3 programs with near-term revenue potential and a Japanese partnership."

Jason Kolbert, Maxim Group (10/14/13) "We conclude that Prochymal represents a long-term accretive acquisition that creates a lot of near-term strategic value for Mesoblast Ltd. as the true leader in the cell therapy space. . .we have included Prochymal in our model, and the impact raises our target price to $14/share from $12/share."

The Life Sciences Report Interview with Jason Kolbert (5/10/13) "Mesoblast Ltd. is the leader in the stem cell space because it has approximately $332M in cash. . .it has a great partner in Teva Pharmaceutical Industries Ltd., which is paying for not only its phase 3 trial for congestive heart failure but also an expanded phase 2 trial with an increase the patient numbers to give it even greater significance. Given the cash balance and the strength of Teva as a partner, it is going to be hard to beat Mesoblast. . .

Mesoblast just reported strong data, not in the cardiovascular space but in degenerative intervertebral disc disease. It showed a high efficacy rate with an associated p-value, or a statistically significant result, which demonstrates it's not just luck. [This] tells me that these cells are really working. In addition, the result is further supported by two earlier trials in a related but different indication, spinal fusion. The two trials reported at the end of last year showed the cell therapy worked just as well as autologous bone graft to successfully fuse a spine. . .if the Mesoblast MPCs show a restoration of vertebral height in humans, many orthopedic surgeons have told me that would be the Holy Grail." More >

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