Source: Streetwise Reports   04/22/2020

The new data are reviewed and updates are provided on Can-Fite BioPharma's other clinical studies, including one for COVID-19, in this Dawson James research report.

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.

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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,

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 CANF 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 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 March 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.

( Companies Mentioned: CANF:NYSE.MKT, )

Source: Streetwise Reports   04/22/2020

The ways in which Moderna is to use the funds are explained and an update on its coronavirus vaccine is provided in a ROTH Capital Partners report.

In an April 19 research note, ROTH Capital Partners analyst Yasmeen Rahimi reported that the Biomedical Advanced Research and Development Authority (BARDA) awarded Moderna Inc. (MRNA:NASDAQ) $483 million in funding, in part for development of its COVID-19 vaccine, mRNA-1273.

Rahimi discussed how Massachusetts-based Moderna will use the funds, which will be provided in tranches to reach certain milestones.

Half of the $483 million award will be used to help cover clinical development costs of mRNA-1273, from trial operations to the filing of a biologics license application.

Currently, the vaccine is in Phase 1 in the clinic. Recently, the biopharma decided to add to the study a cohort of patients aged 51 years and up, which "will be key for demonstrating mRNA-1273's safety and immunogenicity in this vulnerable population," Rahimi noted.

The analyst explained that for mRNA-1273 to advance to Phase 2, the results from Phase 1 must be optimal. The data must demonstrate the vaccine is safe and tolerable. They must show that the vaccine produced a sufficient number of neutralizing antibodies, crucial for stopping viral replication and proving the vaccine's method of action. Phase 1 safety data from the group aged 18–55 years are expected in spring followed by immunogenicity results, likely in mid-July or early August.

Rahimi relayed that as soon as safety data are available, Moderna plans to launch a Phase 2 study of mRNA-1273 rather than wait for the remaining results to become available, according to CEO Stéphane Bancel.

"Pending favorable safety data from Phase 1, we point out that a potential Phase 2 study would enroll hundreds of patients, and that the BARDA funding could potentially allow Moderna to pursue trials in patient populations who are at greater risk, such as patients who have underlying comorbidities, those who are overweight and patients with cancer," commented Rahimi.

Moderna will spend the second half of the $483 million BARDA funding on the engineering and optimization work required to scale up the manufacturing of its messenger RNA (mRNA).

"With the current focus on SARS-CoV-2 and mRNA-1273, Moderna was now able to present BARDA its strategic plans (amount, time and people) of how to be ready for commercial launch," wrote Rahimi. "This preparation was likely helpful in expediting discussions with BARDA and awarding of the grant."

Also regarding mRNA production, Ginkgo Bioworks, a company with expertise in organism biology and genetically engineering bacteria to replace certain industrial applications, is helping Moderna optimize certain parts of the process.

Rahimi, who is closely tracking COVID-19 data, highlighted that April 18 was the first day in five on which the daily death tally, 1,867, was less than that predicted by Dr. Christopher Murray's model, 2,194.

ROTH has a Buy rating on Moderna.

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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 from ROTH Capital Partners, Moderna Inc., Company Note, April 19, 2020

Regulation Analyst Certification ("Reg AC"): The research analyst primarily responsible for the content of this report certifies the following under Reg AC: I hereby certify that all views expressed in this report accurately reflect my personal views about the subject company or companies and its or their securities. I also certify that no part of my compensation was, is or will be, directly or indirectly, related to the specific recommendations or views expressed in this report.

Within the last twelve months, ROTH has received compensation for investment banking services from Moderna, Inc.

ROTH makes a market in shares of Moderna, Inc. and as such, buys and sells from customers on a principal basis.

Within the last twelve months, ROTH has managed or co-managed a public offering for Moderna, Inc.

ROTH Capital Partners, LLC expects to receive or intends to seek compensation for investment banking or other business relationships with the covered companies mentioned in this report in the next three months.

( Companies Mentioned: MRNA:NASDAQ, )

Source: Streetwise Reports   04/23/2020

Shares of West Pharmaceutical Services traded higher and established a new 52-week high price after the firm reported Q1/20 earnings that included a 10.8% increase in YoY revenues.

Global healthcare packaging components manufacturer company West Pharmaceutical Services Inc. (WST:NYSE) today announced financial results for its first quarter ending March 31, 2020 and provided updated full-year 2020 financial guidance.

The company reported that net sales in Q1/20 increased to $491.5 million, a 10.8% increase from $443.5 million in Q1/19. During the same corresponding period, the firm stated that non-GAAP diluted earnings per share (EPS) increased by 36% to $0.99 and non-GAAP adjusted-diluted EPS increased by 36% to $1.01.

West Pharmaceutical Services advised that it is maintaining its FY/20 net sales guidance, which is expected to be in a range of $1.95-1.97 billion. The company stated that it is updating FY/20 adjusted-diluted EPS guidance to a new range of $3.52-3.62, compared to the prior estimated range of $3.45-3.55.

The company's President and CEO Eric M. Green commented, "During these unprecedented times, our priorities are focused on the well-being and safety of our team members as well as ensuring the supply of critical, high-quality components and solutions to our customers...I am extremely pleased that we delivered a strong performance in the first quarter given the challenging environment that the COVID-19 pandemic has had on our customers, our suppliers and our team members. In particular, we continued to deliver strong sales growth in high-value products, as demand trends from our worldwide customer base were similar to trends we saw last year. Our teams are partnering with a broad range of customers working to support efforts to develop solutions that address the global COVID-19 pandemic such as diagnostics, anti-viral therapeutics and vaccines."

The firm outlined sales in the most recent quarter by product line. The company reported that in Q1/20, net sales in its Proprietary Products segment grew by 9.7% to $373.5 million and that this segment "saw good demand for Westar^®, Daikyo^®, NovaPure^® and FluroTec^® components as well as for devices such as Daikyo Crystal Zenith^® syringes and cartridges and our self-injection platforms."

The firm noted that net sales from its Contract-Manufactured Products segment grew by 14.5% to $118.1 million led by sales of components for diagnostic devices and drug-injection delivery devices.

The company added that the Biologics market unit enjoyed double-digit organic sales growth, the Generics market unit achieved high-single digit organic sales growth and the Pharma market unit registered mid-single digit organic sales growth.

The firm additionally noted that during Q1/20 under its share repurchase program, it repurchased 761,500 shares for $115.5 million at an average share price of $151.65.

West Pharmaceutical Services is headquartered in Exton, Pa., roughly 35 miles west of Philadelphia, and is a designer and manufacturer of injectable pharmaceutical packaging and delivery systems.

West Pharmaceutical has market capitalization of around $13.5 billion with approximately 73.84 million shares outstanding. WST shares opened 5.25% higher today at $179.05 (+$8.93, +5.25%) over yesterday's $170.12 closing price and reached a new 52-week high price this morning of $190.27. The stock has traded today between $177.13 and $190.27 per share and is currently trading at $187.04 (+$17.17, +10.11%).

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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: WST:NYSE, )

Source: Streetwise Reports   04/24/2020

Shares of Mesoblast more than doubled and set a new 52-week high price after the company reported that it achieved a 83% survival rate in New York ventilator-dependent COVID-19 patients with moderate to severe acute respiratory distress syndrome who were treated with its allogeneic cell therapy remestemcel-L.

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%).

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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, )

Source: Streetwise Reports   04/27/2020

Avadel Pharmaceuticals' shares traded 25% higher reaching a new 52-week high price after the company reported positive topline results from its Pivotal Phase 3 REST-ON trial of FT218 for the treatment of excessive daytime sleepiness and cataplexy in narcolepsy patients.

Avadel Pharmaceuticals Plc (AVDL:NASDAQ) today announced "positive topline data from its pivotal Phase 3 REST-ON trial assessing the safety and efficacy of FT218, an investigational, once-nightly formulation of sodium oxybate for the treatment of excessive daytime sleepiness and cataplexy in patients with narcolepsy." The firm pointed out that it met all three of the co-primary efficacy endpoints in the study for each of three dosage levels which it claims demonstrates "highly significant, clinically meaningful improvements on the Maintenance of Wakefulness Test, Clinical Global Impression-Improvement and mean weekly cataplexy attacks."

The company's Chief Medical Officer Jordan Dubow, M.D., commented, "We are excited to see these positive topline data from the REST-ON study, where all three dose levels of once-nightly FT218 demonstrated a statistically significant and clinically meaningful improvement on the measures of the two prominent symptoms of narcolepsy, as well as an improvement in overall functioning compared to placebo...Once-nightly FT218 delivered a clinically meaningful response within three weeks of treatment initiation, which was sustained through each treatment period...We think once-nightly FT218, if approved, has the potential to be a meaningful contributor to patient care."

Avadel Pharma's CEO Greg Divis remarked, "The successful outcome of the REST-ON study strengthens our belief that, if approved, once-nightly FT218 has the potential to be a significant advancement for patients in the estimated $1.7 billion twice-nightly sodium oxybate market. Our proprietary market research with physicians and patients informs us that there is a strong interest in a once-nightly sodium oxybate formulation. We look forward to sharing the results from the REST-ON study with the FDA and progressing toward a potential approval that would allow us to bring this important treatment to the patients who need it most. If approved, FT218 would be the first once-nightly therapy to address both excessive daytime sleepiness and cataplexy in patients with narcolepsy."

The REST-ON study is a double-blind, randomized, placebo-controlled Phase 3 trial to assess the efficacy and safety of once-nightly FT218, a formulation of sodium oxybate using Avadel's proprietary Micropump technology for extended-release oral suspension in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. The company stated that 212 patients were enrolled in the study and result "showed that the 9 g dose of once-nightly FT218 demonstrated a highly significant and clinically meaningful improvement compared to placebo across all three co-primary endpoints."

The company advised that FT218 has been granted Orphan Drug Designation from the U.S. FDA for the treatment of narcolepsy. The firm added that the designation was granted on basis that FT218 may be clinically superior to a formulation of sodium oxybate that is already approved by the FDA for the same indication.

Avadel Pharmaceuticals is biopharmaceutical company headquartered in Dublin, Ireland. The company's primary focus is on the development and potential FDA approval for FT218, which just completed its Phase 3 REST-ON clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness and cataplexy. The firm also develops and markets sterile injectable drugs for use in hospital settings.

Avadel started off the day with a market capitalization of around $456.2 million with approximately 46.4 million shares outstanding and a short interest of about 14.00%. AVDL shares opened more than 34% higher today at $13.30 (+$3.37, +34.28%) over Friday's $9.83 closing price and reached a new 52-week high price this morning of $13.49. The stock has traded today between $11.90 and $13.49 per share and is currently trading at $12.27 (+$2.44 +24.82%).

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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: AVDL:NASDAQ, )

Source: Keith Schaefer for Streetwise Reports   04/28/2020

With telehealth becoming a rising star in the coronavirus era, Keith Schaefer discusses why one company rapidly expanding in Canada stands out.

An entirely new—and highly profitable—industry is being borne out in 2020—TeleHealth.

CloudMD Software & Services Inc. (DOC:CSE; DOCRF:OTCQB; 6PH:FSE) is my favorite way to play teleHealth. It's growing quickly with over 100,000 patients registered on its app and over 3000 doctors in 8 provinces in its Electronic Medical Records—EMR—system. It has MULTIPLE revenue streams and it just moved into Canada's largest market—Ontario—setting up an even faster growth rate.

The recent spread of coronavirus is only accelerating this. COVID-19 has forever changed how we all will think about visiting a hospital or seeing our doctor. We really don't want to do that at all, if possible. It will have a very positive and long lasting impact on teleHealth.

teleHealth companies in Canada are getting paid more money for services than bricks-and-mortar clinics, and have a fraction of the costs. Doctors want more of it, patients want more of it, government wants more of it—and the Market REALLY wants more of it. Everybody wins here; there is no downside.

The rapid scale-up and profitability is key for investors.

The stock market is now recognizing this trend—in spades. You can see it in the stock chart of the U.S. leader in teleHealth, Teladoc Health Inc. (TDOC:NYSE).

While the market plummeted Teladoc's business and share price soared.

Now that a firm trend is in place—and teleHealth is one that makes a lot of sense—I'm looking for the junior with the best leverage to this new long term trade.

CloudMD is established, growing quickly and trading at a fraction of its peers.

The average multiple of competitors in the sector trade at 5-7x revenue, and CloudMD is trading way below that at 2.5x per revenue. I'll have more on those comps in a moment.

But realize that the Canadian use of telemedicine is still just a fraction of where it is in the U.S—so the quick, early upside is even bigger.

Literally the Canadian Version of Teladoc Health

The story with this stock is very simple. CloudMD is literally the Canadian version of Teladoc Health—just at an earlier stage in the growth curve.

The market desperately wants to own teleHealth right now (see also the stock charts of LVGO-NASD and CATS-NASD). I see CloudMD as the best way to do that in the junior sector (where the leverage is!).

For this stock to have a major run all that needs to happen is for institutional investors to wake up to the fact that the company exists. That's happening now with the company entering the province of Ontario—which has 14.5 million people, over one-third of Canada's population.

CloudMD is a fully integrated health care company—kind of like a hospital-in-the-sky. They do have five bricks-and-mortar clinics, but they also own their own EMR—Electronic Medical Records—system that operates in eight provinces and is used by over 3,000 doctors and is supported by an in-house 25 person development team. They have their own CloudMD app—which has over 100,000 registered patients already.

Folks, we really are in front of the institutions on this one. I don't have room in this article to even talk to you about the depth and credibility of CEO Dr. Essam Hamza, but after several conversations with him I can say that shareholders are in very good hands.

The EMR gives CloudMD a recurring monthly revenue stream, which The Street loves. The app gives them high margin fees from doctors, specialists and groups like massage therapists and counselors. These people are revenue, not costs. As I said, full hospital-in-the-sky. Multiple revenue sources with lower costs.

To schedule a virtual doctor's appointment all that a patient has to do is download the free CloudMD app and then arrange an appointment with one of the doctors. There is zero charge for the patient and they can see a doctor very quickly.

CloudMD can scale up the number of patients VERY quickly—and they are.

Every aspect of healthcare that's very fractured and disjointed will now be in the one CloudMD ecosystem.

Everyone wins with this system. Patients, doctors, the medical system, society, even investors. Everyone.

TeleHealth Is MUCH More Profitable Than Clinics

Doctors who have signed up with CloudMD work remotely from home or wherever they are (like their winter home down south). The rapid scale-up potential excites me. CloudMD can add in unlimited number of doctors and patients—so it has a virtually unlimited ability to scale quickly with little incremental cost.

Profit margins are wide and there is no cap on the number of customers that can be handled.

After a patient has an appointment, CloudMD bills the government directly just like every bricks-and-mortar clinic in Canada does. CloudMD records 100% of the revenue and gets to keep 30% of the billing for every patient that is seen through telemedicine, which is actually 10% more than what a bricks-and-mortar clinic receives. That is because the governments are trying to push teleHealth.

The doctor gets the other 70% and doesn't have to deal with any headaches of commuting or running a business.

Without the overhead of a bricks-and-mortar clinic, AND more revenue—CloudMD will be much more profitable than traditional health care stocks.

Faster scale, more cash flow. And they just entered Canada's largest market. This is the right stock in the right market at the right time.

When CloudMD goes from one doctor to 10 doctors to 100 doctors working at the same time, they don't have to build more clinics. They don't have to create more rooms for them or hire more staff. They just sign them on. That's it.

And we are not just talking about family doctors. They are also adding specialists and third party services like counseling and physiotherapists to the platform—and again, all these people are revenue, not costs.

That's the great thing about this business model. It's very scalable, very easy, and it grows very quickly.

CloudMD has been growing its recurring SAAS (Software-as-a-Service) revenue by 30% YoY with its EMR system. But this year the company is expecting that doctor growth to be much much higher—with a new full time sales team and the coronavirus pandemic. SaaS revenue is highly lucrative!

Consumer growth (patients) using the CloudMD app is growing even faster. And the recent COVID-19 situation will only turbocharge that.

Another Revenue Stream, Another Win-Win

There's another angle here—pharmacies. CloudMD says they will partner with more than 150 pharmacies in 2020 alone who are afraid of losing prescription business to Amazon (AMZN-NASD).

Those pharmacies are paying $500 a month for CloudMD kiosks to be in their pharmacies—where customers can get a prescription from a doctor on demand.

This keeps the customer in the pharmacy for their prescription—not out to see a doctor and then off to Costco to get it filled.

Pharmacies that don't see the writing on the wall will become the blockbusters of the industry and get left behind.

With the kiosk in the pharmacy, a person can just see a doctor right away, within 10 minutes, and walk the prescription back to the pharmacist.

Buy-outs Are Happening at High Valuations

We know that these businesses are worth.

Grocery giant Loblaws purchased QHR—another Canadian based EMR company—for $3.10/share or 7.5X revenue. Note that QHR's former Chairman Mark Kohler recently joined CloudMD's Board of Directors.

Teladoc bought a company out of Quebec just two months ago called InTouch for about US$600 million, which again is about 7.5X revenue. Teladoc itself trades at more than 10X revenue.

CloudMD trades at 2.5X revenue, less than a third of recent transactions. Meanwhile the company is poised to grow revenues at a high double digit rate for the foreseeable future.

TeleHealth is the future of how our healthcare is delivered.

Everyone has always expected that the growth would be just like what Netflix experienced with streaming, shaped like a hockey stick. The hockey stick shape is slow at the start as early adopters move and then straight up as the mainstream catches up with plot.

The demand for teleHealth from COVID-19 just took the flat part of that hockey stick out of the equation and instead took the industry directly to the exponential growth curve.

The jumping off point for teleHealth is here and I think CloudMD is the best pure-play teleHealth stock right now.

TeleHealth is to healthcare what streaming was to video rentals, and what Amazon was to retail. IT IS THE FUTURE.

Now is the time for investors to get on board, especially in Canada where virtual healthcare only accounts for 0.15% of the market and the growth curve will be much steeper.

And for me, that's CloudMD. It's the new normal. I'm long.

Keith Schaefer is editor and publisher of the Oil & Gas Investments Bulletin. He has a degree in journalism and has worked for several Canadian dailies but has spent over 15 years assisting public resource companies in raising exploration and expansion capital.

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Disclosure:
1) Keith Schaefer: I, or members of my immediate household or family, own shares of the following companies mentioned in this article: CloudMD. I personally am, or members of my immediate household or family are, paid by the following companies mentioned in this article: CloudMD. My company has a financial relationship with the following companies mentioned in this article: None. Additional disclosures are listed below.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees. As of the date of this article, an affiliate of Streetwise Reports has a consulting relationship with CloudMD. Please click here for more information.
3) Statements and opinions expressed are the opinions of the author and not of Streetwise Reports or its officers. The author is wholly responsible for the validity of the statements. The author was not paid by Streetwise Reports for this article. Streetwise Reports was not paid by the author to publish or syndicate this article. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security. Streetwise Reports requires contributing authors to disclose any shareholdings in, or economic relationships with, companies that they write about. Streetwise Reports relies upon the authors to accurately provide this information and Streetwise Reports has no means of verifying its accuracy.
4) This 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. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of CloudMD, a company mentioned in this article.

Keith Schaefer Disclosures:

CloudMD has reviewed and sponsored this article. The information in this newsletter does not constitute an offer to sell or a solicitation of an offer to buy any securities of a corporation or entity, including U.S. Traded Securities or U.S. Quoted Securities, in the United States or to U.S. Persons. Securities may not be offered or sold in the United States except in compliance with the registration requirements of the Securities Act and applicable U.S. state securities laws or pursuant to an exemption therefrom. Any public offering of securities in the United States may only be made by means of a prospectus containing detailed information about the corporation or entity and its management as well as financial statements. No securities regulatory authority in the United States has either approved or disapproved of the contents of any newsletter.

Keith Schaefer is not registered with the United States Securities and Exchange Commission (the "SEC"): as a "broker-dealer" under the Exchange Act, as an "investment adviser" under the Investment Advisers Act of 1940, or in any other capacity. He is also not registered with any state securities commission or authority as a broker-dealer or investment advisor or in any other capacity.

Charts provided by the author.

Source: Streetwise Reports   04/28/2020

SmileDirectClub shares traded 20% higher after the company reported it has been awarded a U.S. patent for its SmileShop retail concept and treatment process and that it plans to reopen stores on a rolling basis starting in May.

SmileDirectClub Inc. (SDC:NASDAQ) today announced "it has been issued a patent for its SmileShop intellectual property from the U.S. Patent & Trademark Office which further strengthens the telehealth dentistry pioneer's efforts to bring affordable, accessible oral care to more people through its unique and innovative teledentistry platform and direct-to-consumer business model." The firm claimed that the patent will prevent other clear aligner competitors from duplicating its business model for the next 18 years.

The company's CEO David Katzman commented, "This patent designation is a significant validation of our unique customer-oriented care model, and expands our category ownership, including the manufacturing and retail experience...As the industry pioneer and inventor of the SmileShop concept, this patent is recognition that SmileDirectClub offers an innovative way for consumers to access oral care that is safe, doctor-directed and convenient. We look forward to welcoming customers back to our SmileShops at the earliest and safest possible time."

"We are focused on the entire teeth straightening and care process, and we now own the manufacturing process of our clear aligner products, the customer experience via our teledentistry platform, as well as the retail experience for clear aligner therapy. This patent is another step in our process as we continue to grow and protect our business," Katzman added.

The firm advised that "the patent encompasses the unique SmileShop concept and process" which includes appointment scheduling, conducting an intraoral scan, generating an approved treatment plan by a licensed dentist or orthodontist and then creating and shipping the aligners to the customer. The company noted that so far more than one million customers have used its clear aligner therapy platform.

The company stated that it is planning to slowly reopen its SmileShops in the U.S. and other markets starting in May as local governments begin to lift business restrictions. The firm indicated that it will be supplying all of its SmileShop team members with face shields and other PPE and will institute staggered appointment times, temperature scans and other social distancing and sanitary measures to provide a safe experience for all staff and customers.

SmileDirectClub is an oral care company headquartered in Nashville, Tenn. The firm stated that it is the creator of the first direct-to-consumer medtech platform for teeth straightening. The company has since expanded its business and now offers its products directly through dentist and orthodontists' offices. Some of the products offered by the company include aligners, impression kits, retainers and whitening gel. In addition to the U.S., the company also operates in Australia, Canada, Germany, Hong Kong, Ireland, New Zealand and the U.K.

SmileDirectClub began the day with a market capitalization of around $2.1 billion with approximately 385 million shares outstanding and a short interest of about 10.4%. SDC shares opened more than 26% higher today at $6.76 (+$1.37, +26.42%) over yesterday's $5.39 closing price. The stock has traded today between $6.13 to $6.80 per share and is currently trading at $6.64 (+$1.25, +23.14%).

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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: SDC:NASDAQ, )

Source: Streetwise Reports   04/29/2020

Shares of Chimerix Inc. traded higher after the company reported it has received U.S. FDA clearance to initiate a Phase 2/3 Study of dociparstat sodium in acute lung injury for patients afflicted with severe COVID-19.

Biopharmaceutical company Chimerix Inc. (CMRX:NASDAQ), which focuses on developing medicines to treat cancer and other serious diseases, today announced that it will initiate a Phase 2/3 study of dociparstat sodium (DSTAT) in COVID-19 patients suffering from acute lung injury (ALI).

The firm explained that "DSTAT is a glycosaminoglycan derivative of heparin with robust anti-inflammatory properties, including the potential to address underlying causes of coagulation disorders with substantially reduced risk of bleeding complications compared to commercially available forms of heparin.^"

Joseph Lasky, M.D., Professor of Medicine, Pulmonary and Critical Care Section Chief, John W. Deming, M.D. Endowed Chair in Internal Medicine at Tulane University Medical School commented, "Given the severity of the COVID-19 pandemic, we have evaluated many potential targets to address the clinical manifestations associated with severe COVID-19...Based on the literature, we believe DSTAT has the potential to reduce the excessive inflammation, immune cell infiltration and hypercoagulation associated with poor outcomes in patients with severe COVID-19 infection."

The company's CEO Mike Sherman remarked, " DSTAT is well-suited to unlock the anti-inflammatory properties of heparin as it may be dosed at much higher levels than any available form of heparin without triggering bleeding complications...We had planned to evaluate DSTAT in several indications of high unmet need, including ALI from different causes. The pandemic intensified our focus on ALI associated with COVID-19. Our team has worked closely with critical care physicians treating COVID-19 patients and with the U.S. Food and Drug Administration (FDA) to develop a Phase 2/3 protocol to determine if DSTAT can reduce the need for mechanical ventilation and improve the rate of survival in patients with severe COVID-19 infection."

The company outlined its plans for the study indicating that it will be a randomized, double-blind Phase 2/3 trial to determine the safety and efficacy of DSTAT in adults with severe COVID-19 who are at a high risk of respiratory failure. The study subjects will be confirmed COVID-19 patients who require hospitalization and supplemental oxygen therapy. The primary endpoint established in the study is the percentage of subjects who survive and do not require mechanical ventilation through 28 days. Several secondary endpoints listed include time needed for showing improvement, time to hospital discharge, time to resolution of fever, number of ventilator-free days, all-cause mortality and changes in several key biomarkers.

The study will begin by enrolling 24 subjects in Phase 2 to first establish dosage levels and then expand to 74 total patients. The firm advised that if Phase 2 results are positive, it would enroll approximately 450 subjects in the Phase 3 portion of the study.

The company reported that "the clinical manifestations of COVID-19 range from mild, self-limited respiratory tract illness to severe alveolar damage and progressive respiratory failure, multiple organ failure, and death. Mortality in COVID-19 is associated with severe pulmonary disease and coagulation disorders such as disseminated intravascular coagulation." The firm indicated that the mechanisms of action of DSTAT may address overactive inflammatory response including underlying causes of blood coagulation disorders associated with COVID-19.

Chimerix is a development-stage biopharmaceutical company based in Durham, N.C. which is engaged in advancing medicines in the areas of cancer and other serious diseases. The company listed that it presently has two active clinical-stage development programs. The first is dociparstat sodium (DSTAT) which is a glycosaminoglycan compound derived from porcine heparin that has low anticoagulant activity. The second pipeline candidate is brincidofovir (BCV) which is an antiviral drug being developed as a medical countermeasure for smallpox.

Chimerix began the day with a market capitalization of around $93.2 million with approximately 61.74 million shares outstanding. CMRX shares opened 30% higher today at $1.97 (+$0.46, +30.46%) over yesterday's $1.51 closing price. The stock has traded today between $1.82 to $2.62 per share and is currently trading at $2.27 (+$0.76, +50.33%).

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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: CMRX:NASDAQ, )

Source: Streetwise Reports   05/06/2020

ProMIS is harnessing its unique technology platform to develop a more error-free antibody test.

Testing has been an Achilles heel of the coronavirus pandemic, but ProMIS Neurosciences Inc. (PMN:TSX; ARFXF:OTCQB) has partnered with Dr. Hans Frykman and the BC Neuroimmunology Lab to use its unique technology to create a more accurate antibody test for SARS-CoV-2, the virus that causes Covid-19.

Two main types of tests exist for Covid-19: one that detects the presence of the virus that causes Covid-19, which indicates a person has an active infection, and another that detects antibodies, showing that a person has been exposed to the virus.

The first test that was developed, a test for the presence of the virus, is used mainly to confirm diagnosis of Covid-19 in people who are showing symptoms such as a fever, a dry, persistent cough, difficulty breathing, a sense of restriction in the chest. "They are typical signs of Covid-19, but we would want to know if these are signs of the common flu or a bad cold or Covid-19. We know that Covid can progress really significantly very quickly, especially in individuals with underlying conditions," ProMIS CEO Dr. Elliot Goldstein told Streetwise Reports. "The number of tests is limited, but it's not actually the tests themselves but the reagents and systems you need to run the test that are in short supply."

"Anytime you conduct a test for the virus and get a negative response, the test indicates only that on that day at that time, the person does not have the virus. The person could have had Covid and recovered, or might have had an asymptomatic or very mild case. Or that person could get the virus tomorrow or in three days," Dr. Goldstein explained. "At any point in time the virus test helps indicate the prevalence of the virus—how many people are actually infected—if you test broadly, and at the time you do it, you can determine whether an individual is currently infected or not."

The second type of test, called serological tests or assays, is also known as an antibody test. "When a person is recovering from a viral infection, the immune system makes antibodies—also called immunoglobulins—that are specific to the virus. They neutralize the virus and help clear it out; that's part of the mechanism of why you get better," Dr. Goldstein explained.

One way to see if a person has had Covid is to test for antibodies. "A positive test means you've been exposed to the virus because, in the absence of a vaccine, that's the only way you would have the antibodies. While it's not 100% certain that antibodies neutralize the virus, based on experience with other coronaviruses, it is likely," Dr. Goldstein said. Having the virus neutralized should offer at least some protection against future re-infections.

People who have had positive virus tests know that they have Covid or had Covid and recovered, but many people are asymptomatic or may have had what felt like a light cold, and they want to know if they are at risk, or if they have some protection against the disease. "This is really important for frontline healthcare workers, people working 8-10 hours a day in intensive care or the emergency room with patients known to be very sick with Covid-19; even with protective equipment, they have significant exposure to the virus," Dr. Goldstein explained. "If someone has been through the disease and has natural antibodies, they can't infect someone else. What you want to know on an individual level is am I safe from infection and am I safe for other people."

Generally, antibody testing is a fairly common procedure, Dr. Goldstein explained. When you spin blood in a centrifuge, it separates into three parts: red blood cells, plasma and serum. Serum is where you find antibodies. "ELISA (enzyme-linked immunosorbent assay) is a standard test that looks for antibodies, but it is not specific enough for the Covid-19 virus."

The challenge is there are multiple coronaviruses. "Four different coronaviruses are responsible for the common cold, and then there are others like SARS and MERS. They all have the same sort of halo or corona of protein around the outside of it," Dr. Goldstein said. "They look like the old naval mines used in war. The whole family of coronaviruses look like that. The amino acid sequences of different coronaviruses are not identical but very similar; they share a lot of common structures. There are only really small differences and you can't really pick them up using the usual physical methods."

Studies have shown that up to 90% of individuals in Western countries have been exposed to one or more of the common cold coronaviruses and have antibodies against them. "They look very similar to the coronavirus causing Covid-19. So in Covid-19 antibody tests, the most important thing is it has to be highly specific for the Covid-19 antibodies and doesn't test positive when it identifies a common cold antibody. That is a false positive," said Dr. Goldstein. "It's actually much safer not to have a test that has a lot of false positives because you could base a behavioral decision on faulty information."

Dr. Goldstein cited an example. "If you are testing 1,000 people and there is a 90% prevalence for the cold virus, that means around 900 people have antibodies to the common cold. If the prevalence of the Covid-19 virus is 2%, roughly 20 of the 1,000 would have antibodies to the Covid-19 virus. Let's say the serology test has 95% specificity. That means five times out of 100, it will give a false positive, indicating the presence of Covid-19 antibodies when it is really picking up antibodies against the cold virus. What this means is 5% of 900, or 45 people, will test positive for Covid when they have not had it, and are making decisions based on incorrect information. The consequences of being wrong are dramatic and highlight the need for a very good, high-quality serological test."

How does this relate to Alzheimer's and other neurological diseases that are ProMIS' core competency? "In Alzheimer's, ALS, frontotemporal dementia, Parkinson's disease and other neurological disease, we've been able to use our proprietary, unique technology to identify sites on misfolded proteins that are driving these diseases. Our core technology is the capability to understand what's special about the bad proteins that are causing these diseases and then we can make antibodies highly selective against them. Our technology allows us to identify a region, an epitopes target, which is a series of four to six amino acids where the protein has misfolded. Not only do we know where this target site is located, importantly we also determine the shape (conformation) of this site. Proteins like amyloid and alpha synuclein and TDP 43 misfold and when these proteins misfold they become toxic, they kill neurons, resulting in disease," Dr. Goldstein explained.

ProMIS has transferred that thinking to the virus causing Covid-19. "The corona is composed of the spiky protein. Remember, we want to be able to distinguish between the coronavirus causing the common cold and the coronavirus causing Covid-19," Dr. Goldstein said. "If we can distinguish between the two, we can have an antibody test that's specific for Covid-19. We are looking at a region of the virus called the receptor binding domain, the RBD, that is part of the spike protein and how it attaches to cells. We have a core competency that allows us to identify sites, and not just the location of the sites, but the shape of the sites on complex protein molecules. That allows us then to use that knowledge to create either antibodies or to create serum tests, or even quite frankly, we can use those targets to create vaccines."

Using ProMIS' proprietary technology, the company has been able to "identify a site that we believe is only present on the Covid-19 virus and not on other coronaviruses. We are now initiating the synthesis of several different forms of that site; it's a small area," Dr. Goldstein stated. "That would then transfer to Dr. Hans Frykman's lab at University of British Columbia, a world-class serology lab. Then we will see if the targets we've identified are specific and selective antibodies against Covid-19."

When you test the serum of an individual, if they've been exposed to the virus and have the antibodies, "those antibodies should bind selectively and specifically to the target. So if the antibodies from the patient's serum are binding to the target site, we know it's a Covid-19 virus because that site is only visible in that shape on the Covid-19 virus and not the others. For the validation of our test, only in patients known to have had Covid-19 should we see binding of antibodies against Covid-19 to our target. The second validation is based on testing in serum from subjects known to have never been exposed to Covid-19 virus—such subjects have antibodies only from cold or other coronaviruses, and therefore the antibody test should be negative; there should be no binding. So we should only see binding in serum from a patient known to have recovered from COVID-19, and we should not see binding in serum from an individual known not to have been exposed to COVID-19," Dr. Goldstein explained.

"Our technology basically allows us to zero in with sniper-like precision on the structure of a protein and understand it, not only the structure overall but the shape of the regions on that protein and then that allows us to identify what is specific to that protein, in this case the spiky protein on the virus causing COVID-19," said Dr. Goldstein.

ProMIS expects to have initial results in June.

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Disclosure:
1) Patrice Fusillo compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an employee. 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: ProMIS Neurosciences. 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. As of the date of this article, officers and/or employees of Streetwise Reports LLC (including members of their household) own securities of ProMIS, a company mentioned in this article.
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: PMN:TSX; ARFXF:OTCQB, )

Source: Streetwise Reports   05/01/2020

Seattle Genetics shares traded 8% higher, reaching a new 52-week high, after the company reported Q1/20 financial results which included a 10% y-o-y increase in net revenues fueled by a 22% increase in sales of ADCETRIS® and a strong debut for PADCEV™ in its first full quarter of sales.

Seattle Genetics Inc. (SGEN:NASDAQ) yesterday announced financial results for the first quarter ended March 31, 2020.

The company also provided an update on commercial results achieved in the quarter for its lead medicines including ADCETRIS® (brentuximab vedotin) and PADCEV^™ (enfortumab vedotin-ejfv) and the U.S. Food and Drug Administration's (FDA) approval and launch of TUKYSA^™ (tucatinib).

The company's President and CEO Clay Siegall, Ph.D., commented, "We have had a remarkable start to 2020, delivering record product sales in the first quarter that are now coming from both ADCETRIS and PADCEV. Notably, strong PADCEV sales in the first full quarter of launch reflect the unmet need among patients with metastatic bladder cancer...With the recent approval of TUKYSA for patients with metastatic HER2-positive breast cancer, we have now launched our third product just four months after our second...We are also preparing for European commercial operations and have hired general managers in major European markets ahead of potential ex-U.S. approvals of TUKYSA. With two new products, growing revenues, and an advancing pipeline of novel cancer programs, we have exciting prospects for future growth."

The company highlighted that ADCETRIS net sales in the U.S. and Canada increased by 22% to $164.1 million in Q1/20, compared to $135 million in Q1/19. The firm indicated that PADCEV net sales in the U.S. reached $34.5 million in Q1/20, which was its first full quarter of commercialization. The company added that royalty revenues in Q1/20 were $20.4 million and collaboration and license agreement revenues in Q1/20 totaled $15.6 million.

The firm reported a net loss for Q1/20 of $168.4 million, or $0.98 per diluted share, compared to net loss of $13.3 million, or $0.08 per diluted share for Q1/19. The company explained that "the net loss in Q1/20 included a net investment loss of $59.1 million primarily associated with its common stock holdings in Immunomedics, which are marked-to-market, compared to a net investment gain of $38.1 million in Q1/19."

The company advised that its TUKYSA was approved by the FDA for patients with HER2-positive metastatic breast cancer who have received one or more prior anti-HER2 regimens in the metastatic setting. The firm mentioned that it also expects to be able to report topline data in late Q2/20 or Q3/20 for the innovaTV 204 pivotal trial of tisotumab vedotin in patients with recurrent and/or metastatic cervical cancer who have relapsed or progressed after standard of care treatment.

The company noted that it is regularly monitoring the effects of the COVID-19 situation and is maintaining its business outlook estimates for FY/20 that it provided previously on February 6, 2020. For FY/20 it expects ADCETRIS net product sales of $675–700 million, royalty revenues of $105–115 million and collaboration and license agreement revenues of $30–50 million. The firm advised that for FY/20 it expects that R&D expenses will range from $860–950 million with SG&A expenses of $475–525 million.

Seattle Genetics is headquartered in Bothell, Wash., and is a global biotechnology company focused on discovering and commercializing cancer medicines.

Seattle Genetics has a market capitalization of around $23.7 billion with approximately 172.5 million shares outstanding. SGEN shares opened 2.75% higher today at $141.00 (+$3.77, +2.75%) over yesterday's $137.23 closing price and reached a new 52-week high price this morning of $157.00. The stock has traded today between $140.05 and $157.00 per share and is currently trading at $148.51 (+$11.28, +8.22%).

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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: SGEN:NASDAQ, )

Source: Streetwise Reports   05/04/2020

Shares of Stemline Therapeutics traded 150% higher after the company reported that it has entered into a definitive agreement to be acquired by Italy's Menarini Group in a deal valued at up to $677 million.

Stemline Therapeutics Inc. (STML:NASDAQ), which is focused on developing and commercializing novel oncology therapeutics, today announced that it has entered into a definitive agreement to be acquired by private Italian pharmaceutical and diagnostics company Menarini Group in a transaction valued up to $677 million.

The companies advised that the transaction has already been unanimously approved by both companies' Boards of Directors and that the transaction is expected to close in Q2/20 subject to customary closing conditions, regulatory approvals and a tender of at least 50% of the outstanding Stemline shares by shareholders. Menarini stated that it plans to fund the purchase by using existing cash resources.

The firms outlined that purchase details and advised that "under the terms of the agreement, a wholly owned subsidiary of the Menarini Group will commence a tender offer for all outstanding shares of Stemline, whereby Stemline shareholders will be offered a total potential consideration of $12.50 per share, consisting of an upfront payment of $11.50 in cash and one non-tradeable Contingent Value Right (CVR) that will entitle each holder to an additional $1.00 in cash per share upon completion of the first sale of ELZONRIS in any EU5 country after European Commission approval."

The report explained that ELZONRIS is a novel targeted therapy directed to the interleukin-3 (IL-3) receptor-α (CD123) and was developed by Stemline for treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN) in adult and pediatric patients. The firm stated that the U.S. Food and Drug Administration (FDA) approved that drug in the U.S. in December 2018. A marketing authorization application (MAA) has already been submitted and is presently under review by the European Medicines Agency. Post acquisition, Menarini expects to obtain approvals and expand distribution of ELZONRIS to Europe and emerging markets.

Stemline Therapeutics' Chairman, CEO and Founder Ivan Bergstein, M.D., commented, "Joining Menarini represents a unique opportunity for Stemline to advance the commercialization of ELZONRIS across the globe and to accelerate the development of our pipeline of oncology assets. ...We are excited to be combining with a like-minded organization in Menarini, in a transaction that will deliver immediate and significant cash value to our shareholders, while also allowing our shareholders to participate in the future upside of ELZONRIS's European launch."

Elcin Barker Ergun, CEO of Menarini Group, remarked, "Stemline is an excellent fit for Menarini, enabling us to expand our presence in the U.S. with an established biopharmaceutical company focused on developing oncology therapeutics. Through this acquisition, we will continue to strengthen our portfolio and pipeline of oncology assets and deliver novel therapies around the world."

The company described BPDCN, formerly blastic NK-cell lymphoma, as "an aggressive hematologic malignancy, often with cutaneous manifestations, with historically poor outcomes which typically presents in the bone marrow and/or skin and may also involve lymph nodes and viscera."

Stemline Therapeutics is a commercial-stage biopharmaceutical company headquartered in New York that develops and markets oncology therapeutics. The firm stated that its "ELZONRIS^® (tagraxofusp) is a targeted therapy directed to CD123 and is FDA-approved and commercially available in the U.S. for the treatment of adult and pediatric patients, two years and older, with BPDCN." Stemline noted that ELZONRIS is also being currently being evaluated in clinical studies for other indications including chronic myelomonocytic leukemia, myelofibrosis and acute myeloid leukemia.

The Menarini Group is an international pharmaceutical company based in Italy which operates and sells its products in more than 100 countries. The company stated that it has $4.2 billion in sales annually. The company's medicines address many areas of illnesses including cardiovascular, gastroenterology, metabolic, infectious diseases and anti-inflammatory/analgesic therapeutic areas and oncology.

Stemline Therapeutics began the day with a market capitalization of around $249.2 million with approximately 54.27 million shares outstanding and a short interest of about 11.3%. STML shares opened nearly 150% higher today at $11.81 (+$7.06, +148.63%) over Friday's closing price of $4.75. The stock has traded today between $1.81 and $12.35 per share and is currently trading at $12.10 (+$7.35, +154.74%).

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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: STML:NASDAQ, )

Source: Streetwise Reports   05/05/2020

Shares of Portola Pharmaceuticals traded 130% higher after the company reported that it has received an $18 per share buyout offer from Alexion Pharmaceuticals.

Commercial-stage biotechnology company Portola Pharmaceuticals Inc. (PTLA:NASDAQ), which focuses on blood-related disorders, and global biopharmaceuticals firm Alexion Pharmaceuticals Inc. (ALXN:NASDAQ) announced that they have entered into a definitive merger agreement for Portola to be acquired by Alexion.

The acquisition is said to provide a key addition to Alexion's diversified commercial portfolio. The report indicated that the merger agreement has already been unanimously approved each of the company's boards of directors.

The report explained that "Portola's commercialized medicine, Andexxa^® [coagulation factor Xa (recombinant), inactivated-zhzo], marketed as Ondexxya^® in Europe, is the first and only approved Factor Xa inhibitor reversal agent, and has demonstrated transformative clinical value by rapidly reversing the anticoagulant effects of Factor Xa inhibitors rivaroxaban and apixaban in severe and uncontrolled bleeding."

Portola's President and CEO Scott Garland commented, "In developing and launching Andexxa, Portola has established a strong foundation for changing the standard of care for patients receiving Factor Xa inhibitors that experience a major, life-threatening bleed. Andexxa rapidly reverses the pharmacologic effect of rivaroxaban and apixaban within two minutes, reducing anti-Factor Xa activity by 92 percent...Given their enhanced resources, global footprint and proven commercial expertise, we look forward to working with Alexion to maximize the value of Andexxa. With their commitment to commercial excellence, together, we will be able to drive stronger utilization of Andexxa, increase penetration and accelerate adoption in the critical care setting."

Ludwig Hantson, Ph.D., CEO of Alexion, remarked, "The acquisition of Portola represents an important next step in our strategy to diversify beyond C5. Andexxa is a strategic fit with our existing portfolio of transformative medicines and is well-aligned with our demonstrated expertise in hematology, neurology and critical care...We believe Andexxa has the potential to become the global standard of care for patients who experience life-threatening bleeds while taking Factor Xa inhibitors apixaban and rivaroxaban. By leveraging Alexion's strong operational and sales infrastructure and deep relationships in hospital channels, we are well positioned to expand the number of patients helped by Andexxa, while also driving value for shareholders."

The firms advised that "under the terms of the merger agreement, a subsidiary of Alexion will commence a tender offer to acquire all of the outstanding shares of Portola's common stock at a price of $18 per share in cash." Alexion plans to fund the purchase with existing cash on hand and the transaction is expected to close in Q3/20. The purchase is subject to approval by a majority interest of Portola's common stockholders tendering their shares along with ordinary closing conditions and regulatory approvals. The company noted that "following successful completion of the tender offer, Alexion will acquire all remaining shares not tendered in the offer at the same price of $18 per share through a merger."

Alexion is a global biopharmaceutical company based in Boston, Mass., with offices in 50 countries worldwide. The company states that it has been "the global leader in complement biology and inhibition for more than 20 years and that it has developed and commercializes two approved complement inhibitors to treat patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome, as well as the first and only approved complement inhibitor to treat anti-acetylcholine receptor antibody-positive generalized myasthenia gravis and neuromyelitis optica spectrum disorder."

Portola is headquartered in South San Francisco, Calif., and is a commercial-stage biopharmaceutical company focused on treating patients with serious blood-related disorders. Specifically, the company is engaged in developing and commercializing novel therapeutics in order to advance the fields of thrombosis and other hematologic conditions. The firm listed that its first two commercialized products are Andexxa^® and Bevyxxa^® (betrixaban), and that it is also advancing and developing cerdulatinib, a SYK/JAK inhibitor for use in treatment of hematologic cancers.

Portola Pharmaceuticals started off the day with a market capitalization of around $609.0 million with approximately 78.5 million shares outstanding and a short interest of about 23.0%. PTLA shares opened 130% higher today at $17.85 (+$10.09, +130.03%) over yesterday's $7.85 closing price. The stock has traded today between $17.71 and $17.91 per share and is currently trading at $17.83 (+$10.07, +129.77%).

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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.

Source: Streetwise Reports   05/06/2020

Arcturus Therapeutics Holdings' arrangement is explained and commented on in an H.C. Wainwright & Co. report.

In a May 4 research note, H.C. Wainwright & Co. analyst Ed Arce reported that Arcturus Therapeutics Holdings Inc. (ARCT:NASDAQ) formed a partnership with Catalent Inc. (CTLT:NYSE), which "raises the profile of LUNAR-COV19 as a leading vaccine candidate."

Arce reviewed Catalent's contribution to the partnership. The global contract development and manufacturing organization is to manufacture Arcturus' messenger RNA (mRNA) LUNAR-COV19 for protection against SARS-CoV-2 to be used first for human clinical trials and potentially, eventually commercially.

As for timing, Arce noted, San Diego, Calif.-based Arcturus intends to transfer its vaccine technology to Catalent this month and expects Catalent to manufacture the first batches of LUNAR-COV19 by June 2020. "Critically, Arcturus continues to anticipate initiation of Phase 1 testing of LUNAR-COV19 in the summer of 2020," Arce highlighted.

Catalent is to produce the vaccine at its biomanufacturing facility in Madison, Wisc. "This facility utilizes Catalent's flex-suite, a current good manufacturing practice manufacturing suite, that can produce batches at multiple scales and support Arcturus' proprietary mRNA manufacturing process," explained Arce.

Obtaining the vaccine from one facility domestically versus multiple entities worldwide should result in several benefits, Arce continued. They include easy development and production, accelerated delivery and improved costs. Arcturus believes Catalent can produce millions of doses of LUNAR-COV19 mRNA in 2020 and, if need be, hundreds of millions of doses each year subsequently for use globally.

Arce pointed out that LUNAR-COV19 differentiates itself from other similar vaccine candidates in that the technology and delivery platform behind it deliver an "extraordinarily low dose (perhaps 2 micrograms)" in "a potential single shot."

H.C. Wainwright has a Buy rating and a $62 per share price target on Arcturus, the stock of which is currently trading at about $42.12 per share.

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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.
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 from H.C. Wainwright & Co., Arcturus Therapeutics Holdings Inc., First Take, May 4, 2020

Investment Banking Services include, but are not limited to, acting as a manager/co-manager in the underwriting or placement of securities, acting as financial advisor, and/or providing corporate finance or capital markets-related services to a company or one of its affiliates or subsidiaries within the past 12 months.

I, Ed Arce, certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.

None of the research analysts or the research analyst's household has a financial interest in the securities of Arcturus Therapeutics Holdings Inc. (including, without limitation, any option, right, warrant, future, long or short position).

As of April 30, 2020 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Arcturus Therapeutics Holdings Inc.

Neither the research analyst nor the Firm has any material conflict of interest in of which the research analyst knows or has reason to know at the time of publication of this research report.

The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services.

The firm or its affiliates received compensation from Arcturus Therapeutics Holdings Inc. for non-investment banking services in the previous 12 months.

The Firm or its affiliates did receive compensation from Arcturus Therapeutics Holdings Inc. for investment banking services within twelve months before, and will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report.

H.C. Wainwright & Co., LLC managed or co-managed a public offering of securities for Arcturus Therapeutics Holdings Inc. during the past 12 months.

The Firm does not make a market in Arcturus Therapeutics Holdings Inc. as of the date of this research report.

H.C. Wainwright & Co., LLC and its affiliates, officers, directors, and employees, excluding its analysts, will from time to time have long or short positions in, act as principal in, and buy or sell, the securities or derivatives (including options and warrants) thereof of covered companies referred to in this research report.

( Companies Mentioned: ARCT:NASDAQ, )

Source: Streetwise Reports   05/06/2020

Shares of Horizon Therapeutics traded higher setting a new 52-week high price after the company reported a 27% y-o-y increase in net sales for Q1/20 and raised FY/20 net sales guidance.

Biopharmaceutical company Horizon Therapeutics Inc. (HZNP:NASDAQ), which focuses on developing and commercializing medicines for treatment of rare and rheumatic diseases, today announced its Q1/20 financial results for the period ending March 31, 2020. The firm began by advising that it is raising its FY/20 net sales guidance and revised its adjusted EBITDA guidance.

For Q1/20 the company reported that net sales increased by 27% to $355.9 million over Q1/19. The firm provided a breakdown of revenue by business unit and listed that in Q1/20 compared with Q1/19, its Orphan segment net sales increased 47% to $245.4 Million, KRYSTEXXA® net sales rose by 78% to $93.3 million and TEPEZZA (teprotumumab-trbw) net sales were $23.5 million, which exceeded expectations.

The firm advised that it is increasing FY/20 net sales guidance to $1.40-1.45 billion driven primarily by significantly higher TEPEZZA net sales and reflecting anticipated impacts from COVID-19. The company also presented revised FY/20 adjusted EBITDA guidance of $450-500 million, which reflects increased TEPEZZA program investment to support higher-than-expected demand.

The firm indicated that in Q1/20 it posted a GAAP net loss of $13.6 million with adjusted EBITDA of $107.2 million and non-GAAP net income of $83.2 million.

The company's Chairman, President and CEO Timothy Walbert commented, "We had a very strong start to 2020, highlighted by the early approval and rapid uptake of TEPEZZA, which significantly exceeded expectations, excellent KRYSTEXXA growth and our recent acquisition of HZN-825...We are increasing our full-year net sales guidance to account for significantly higher TEPEZZA net sales that more than offset the expected impact from COVID-19 this year, and we are widening both our net sales and adjusted EBITDA guidance ranges to account for future uncertainty. The fundamentals of our business are strong, including a robust cash position, and we continue to be very well positioned for the long term."

The company noted that it received FDA approval for TEPEZZA for the treatment of thyroid eye disease (TED) earlier this year in January. The firm described TED as "a rare, serious, progressive and vision-threatening autoimmune disease, and is associated with proptosis (eye bulging), diplopia (double vision), blurred vision, pain and facial disfigurement." The company further s explained that "TEPEZZA, a fully human monoclonal antibody insulin-like growth factor-1 receptor (IGF-1R) inhibitor, is the first and only FDA-approved medicine for the treatment of TED."

Horizon Therapeutics is a biopharmaceutical company headquartered in Dublin, Ireland. The firm researches, develops and commercializes medicines for treatment of rare and rheumatic diseases.

Horizon has a market capitalization of around $7.1 billion with approximately 190.2 million shares outstanding and a short interest of about 4.9%. HZNP shares opened 10% higher today at $44.19 (+$3.81, +10.19%) over yesterday's $37.38 closing price and reached a new 52-week high price this morning of $43.57. The stock has traded today between $40.00 and $43.90 per share and is currently trading at $42.95 (+$5.57, +14.90%).

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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.

The elements of Goodrich Petroleum that make it a Buy are presented in a ROTH Capital Partners report.

This project, along with two other new projects, increases the company's order backlog by 65%.

Shares of WPX Energy traded 25% higher after President Trump tweeted that he expected a deal between Russia and Saudi Arabia to scale back oil production.

Jordan Trimble of Skyharbour Resources lays out the reasons why the uranium bear market is coming to an end, and why his company is poised to take advantage of the upturn, in this conversation with Maurice Jackson of Proven and Probable.

With onshore storage becoming increasingly scarce, the volume of oil being stored on ships will continue to rise, delivering a once-in-a-generation opportunity for oil tankers, according to McAlinden Partners.

With the recent 22% rise in the price of uranium, Peter Epstein of Epstein Research considers the upside for Skyharbour's holdings in the Athabasca Basin.

The status and potential implications of this deal involving BP as the seller are discussed in a Raymond James report.

Shares of Energous Corp. skyrocketed after the company reported that it received certification from the FCC for its new, "groundbreaking" over-the-air, power-at-a-distance wireless charging WattUp® technology.

With the supply/demand balance moving in favor of miners, the outlook for uranium stocks is the brightest it has been in years, according to McAlinden Research Partners.

The new agreement and its potential impact on Point Loma Resources are discussed in a Mackie Research Capital Corp. report.

Though sector expert Michael Ballanger's focus is on the precious metals, given current market conditions he sees potential in oil as well.

Greenbriar Capital has signed an agreement for the design and construction of the Caribbean's largest solar project.

Shares of Kraton Corp. traded 24% higher after the specialty polymers and high-value biobased products maker reported that net income in Q1/20 increased to $209.0 million, compared to $13.6 million in Q1/19.

A recap of Parsley Energy's Q1/20 performance and projections for this year and next are given in a Raymond James report.

Shares of ION Geophysical traded higher after the company reported Q1/20 financial results that included a 53% year-over-year increase in revenue.