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Source: Streetwise Reports   04/22/2020

In an April 20 research note, Dawson James analyst Jason Kolbert wrote that results from Can-Fite BioPharma Ltd.'s (CANF:NYSE.MKT) Phase 2 trial of Namodenoson for nonalcoholic fatty liver disease with or without nonalcoholic steatohepatitis "look pretty good."

He added that "the consistency of the data from the studies (preclinical and clinical), should support business development interest."

Dawson James has a $9 per share target price on Can-Fite; the stock is currently trading at around $1.75 per share.

Kolbert recapped the study design and provided the results.

This purpose of this multicenter, randomized, double-blinded, placebo-controlled trial involving 60 patients was to determine dose efficacy and safety. Patients were treated twice a day with either 12.5 milligrams or 25 milligrams of oral Namodenoson or a placebo for 12 weeks.

The primary endpoint was effect on inflammation, measured by mean percent change from baseline in alanine transaminase blood levels and safety. The second endpoints included the percent change from baseline in liver fat, as determined by MRI proton density fat fraction.

In terms of safety, study participants tolerated Namodenoson at both doses, and no adverse events were reported. Otitis media occurred in two patients but was deemed to be unrelated to the drug. The four other events that occurred that were drug related were mild and self-limited.

Regarding efficacy of Namodenoson, Kolbert noted that "for a small Phase 2 exploratory study, there appears to be a significant efficacy signal."

Kolbert provided updates on other Can-Fite clinical trials.

The company's COVID-19 trial is now designed. Plans call for it to be randomized, open label, and double armed with Piclidenoson administered plus standard supportive care, compared to standard supportive care alone, in 40 hospitalized COVID-19-infected patients with moderate to severe symptomatic disease.

Patients are to be randomized at a 1:1 ratio to one of the trial arms and treated for up to four weeks. The primary efficacy measures will be time to resolution of viral shedding, time to resolution of clinical symptoms, respiratory function, need for ventilatory support and overall mortality.

Piclidenoson, Can-Fite's lead drug candidate, also is in Phase 3 in two indications: moderate to severe rheumatoid arthritis (the ACROBAT study) and moderate to severe plaque psoriasis (the COMFORT study). Enrollment for both trials is more halfway complete. In both, Piclidenoson "hold great promise as alternative therapies with what appears to be a more favorable side effects profile," Kolbert commented.

Dawson James has a Buy rating on Can-Fite BioPharma.

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 interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

Disclosures for Dawson James Securities, Can-Fite BioPharma Ltd., April 20, 2020,

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.

( Companies Mentioned: CANF:NYSE.MKT, )

Source: Streetwise Reports   04/24/2020

Mesoblast Ltd. (MESO:NASDAQ; MSB:ASX) today announced that it had achieved an "83% survival in ventilator-dependent COVID-19 patients (10/12) with moderate/severe acute respiratory distress syndrome (ARDS) treated during the period March-April 2020 with two intravenous infusions of Mesoblast's allogeneic mesenchymal stem cell product candidate remestemcel-L within the first five days." The company stated that of the 12 patients treated, 75% (9/12) successfully came off ventilator support after a median timeframe of 10 days. The firm advised that all of the patients were treated under an emergency Investigational New Drug (IDA) application or expanded access protocol at Mt. Sinai hospital in New York City and so far seven of the patients have been discharged from the hospital. The company noted that each of the patients had received a variety of experimental agents prior to being treated with remestemcel-L.

The firm explained that until now only about 9% (38/445) of ventilator-dependent COVID-19 patients at a major referral hospital network in New York City were able to come off ventilator support when treated with existing standard of care treatments during March and April 2020. The company reported that at a second major referral hospital network in New York City over the same period, there was 88% mortality with only 12% survival (38/320) among ventilator-dependent COVID-19 patients.

The company's CEO Dr. Silviu Itescu commented, "The remarkable clinical outcomes in these critically ill patients continue to underscore the potential benefits of remestemcel-L as an anti-inflammatory agent in cytokine release syndromes associated with high mortality, including acute graft versus host disease and COVID-19 ARDS. We intend to rapidly complete the randomized, placebo-controlled Phase 2/3 trial in COVID-19 ARDS patients to rigorously confirm that remestemcel-L improves survival in these critically ill patients."

Dr. Fred Grossman, Mesoblast's Chief Medical Officer, added, "There is a significant need to improve the dismal survival outcomes in COVID-19 patients who progress to ARDS and require ventilators. We have implemented robust statistical analyses in our Phase 2/3 trial as recommended by the US Food and Drug Administration (FDA) in order to maximize our ability to evaluate whether remestemcel-L provides a survival benefit in moderate/severe COVID-19 ARDS."

Mesoblast Ltd. is headquartered in Melbourne, Australia, and is a developer of industrial-scale, cryopreserved, off-the-shelf allogeneic cellular medicines. The company utilizes its proprietary mesenchymal lineage cell therapy technology platform in order to create a wide portfolio of commercial products and late-stage product candidates. The firm indicated that "the Biologics License Application to seek approval of its product candidate RYONCIL™ (remestemcel-L) for steroid-refractory acute graft versus host disease has been accepted for priority review by the U.S. Food and Drug Administration." The company has offices in Australia, the U.S. and Singapore.

Mesoblast began the day with a market capitalization of around $687.9 million with approximately 106.7 million shares outstanding. MESO shares opened nearly 142% higher today at $15.59 (+$9.14, +141.71%) over yesterday's $6.45 closing price and reached a new 52-week high price this morning of $20.57. The stock has traded today between $13.01 and $20.57 per share and is presently trading at $14.76 (+$8.30, +128.76%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his 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 interview or the decision to write an article until three business days after the publication of the interview or 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.

( Companies Mentioned: MESO:NASDAQ; MSB:ASX, )

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