In an Oct. 13 research note, Dawson James Securities analyst Jason Kolbert reported that Mesoblast Ltd.'s (MESO:NASDAQ; MSB:ASX) Phase 3 COVID-19 acute respiratory distress syndrome (ARDS) clinical trial is 50%-plus enrolled.
Up to 300 ventilator-dependent patients with moderate to severe ARDS will be enrolled in total in up to 30 teaching hospitals throughout North America. Recruitment is expected to be completed in three to four months.
Kolbert briefly reviewed the other study design components and objectives. The randomized, double-blinded, controlled trial will evaluate Mesoblast's mesenchymal stem cell product, remestemcel-L, plus maximal care in ARDS, the main cause of death in patients with COVID-19. Study patients will receive either remestemcel-L or placebo.
The primary trial endpoint is mortality at 30 days. The secondary endpoint is the number of days alive, off of ventilator support, within 60 days. An interim analysis is planned when 30% of enrolled patients reach the first endpoint.
With the study, Mesoblast aims to confirm the results of a pilot study carried out earlier this year, in March and April, at New York's Mount Sinai Hospital, Kolbert noted. It showed that nine of 12, or 75%, of ventilator-dependent inpatients were taken off of ventilator support due to improvement and discharged a median of 10 days after receiving two intravenous doses of remestemcel-L within five days.
Should the Phase 3 data readout be positive, Kolbert indicated, the next steps for Australia-based Mesoblast are to obtain fast-tracked regulatory approval, expand manufacturing capabilities and develop manufacturing and commercialization partnerships.
Dawson James has a Buy rating and a $20 per share target price on Mesoblast, the stock of which is currently trading at about $11.81 per share.
[NLINSERT]Disclosure:
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the decision to publish an article until three business days after the publication of the article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.
Disclosures for Dawson James Securities, Mesoblast, October 13, 2020,
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 September 31, 2020, 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 analyst’s 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.
