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TICKERS: MESO; MSB

Regenerative Medicine Firm Reports Positive Chronic Lower Back Pain Trial Results
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New study data and next steps for Mesoblast's MPC-06-ID are presented in a Dawson James Securities report.

In a Feb. 11 research report, Dawson James Securities analyst Jason Kolbert reported that the results of Mesoblast Ltd.'s (MESO:NASDAQ; MSB:ASX) Phase 3 trial of MPC-06-ID, or rexlemestrocel-L, for treatment of degenerative disc disease-caused chronic lower back pain "look good" and "approval could follow."

"The data shows that a that injection of rexlemestrocel-L appears to provide durable and effective opioid sparing therapy for patients with chronic inflammatory back pain due to degenerative disc disease. Relief appears to be durable for two years-plus from a single administration," the analyst wrote.

Kolbert reviewed the new study data.

In this Phase 3 trial, more than 400 patients with chronic lower back pain (CLBP) were administered one injection containing six mesenchymal precursor cells and hyaluronic acid. The majority of patients, 391 of them, experienced "significant and durable reductions in CLBP," and pain relief continued through the 24-month follow-up period.

A subset of patients, 194 of them, experienced greater pain relief than the others. At the start of the trial, this group had fewer than 68 months of constant pain, the median pain duration of the entire study population. Further, this subset experienced that heightened pain relief at each point it was assessed, at 1, 3, 6, 12, 18 and 24 months.

A different subset of patients, this one of opioid users (n=169), also experienced greater pain relief at each of those same time points.

For the patients who went into the study already having CLBP for more than 68 months, "the composite outcomes of pain and function did not reach statistical significance across the entire study," noted Kolbert.

Study participants did not report any adverse events throughout the 24-month follow-up period.

Kolbert also pointed out that a previous randomized controlled trial of combination MPC-06-ID and hyaluronic acid, the Phase 2 trial, showed durable pain reduction.

Given all of these results, Mesoblast intends to meet with the U.S. Food and Drug Administration to discuss next steps and a pathway to approval of MPC-06-ID plus hyaluronic acid as a treatment for CLBP due to degenerative disc disease.

Dawson James has a Buy rating and a $16 per share price target on Mesoblast, the current share price of which is about $10.30.

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Disclosures for Dawson James Securities, Mesoblast, February 11, 2021

The Firm does not make a market in the securities of the subject company(s). The Firm has NOT engaged in investment banking relationships with MESO in the prior twelve months, as a manager or co-manager of a public offering and has NOT received compensation resulting from those relationships. The Firm may seek compensation for investment banking services in the future from the subject company(s). The Firm has NOT received other compensation from the subject company(s) in the last 12 months for services unrelated to managing or co-managing of a public offering.

Neither the research analyst(s) whose name appears on this report nor any member of his (their) household is an officer, director or advisory board member of these companies. The Firm and/or its directors and employees may own securities of the company(s) in this report and may increase or decrease holdings in the future. As of January 31, 2021, the Firm as a whole did not beneficially own 1% or more of any class of common equity securities of the subject company(s) of this report. The Firm, its officers, directors, analysts or employees may affect transactions in and have long or short positions in the securities (or options or warrants related to those securities) of the company(s) subject to this report. The Firm may affect transactions as principal or agent in those securities.

Analysts receive no direct compensation in connection with the Firm's investment banking business. All Firm employees, including the analyst(s) responsible for preparing this report, may be eligible to receive non-product or service specific monetary bonus compensation that is based upon various factors, including total revenues of the Firm and its affiliates as well as a portion of the proceeds from a broad pool of investment vehicles consisting of components of the compensation generated by investment banking activities, including but not limited to shares of stock and/or warrants, which may or may not include the securities referenced in this report.

Analyst Certification: The analyst(s) whose name appears on this research report certifies that 1) all of the views expressed in this report accurately reflect his (their) personal views about any and all of the subject securities or issuers discussed; and 2) no part of the research analystís compensation was, is, or will be directly or indirectly related to the specific recommendations or views expressed by the research analyst in this research report; and 3) all Dawson James employees, including the analyst(s) responsible for preparing this research report, may be eligible to receive non-product or service specific monetary bonus compensation that is based upon various factors, including total revenues of Dawson James and its affiliates as well as a portion of the proceeds from a broad pool of investment vehicles consisting of components of the compensation generated by investment banking activities, including but not limited to shares of stock and/or warrants, which may or may not include the securities referenced in this report.





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