Source: Streetwise Reports   04/27/2020

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%).

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: Streetwise Reports   04/28/2020

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%).

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

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%).

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

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.

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   05/06/2020

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.

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, )

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My new book LOSERTHINK, available now on Amazon https://tinyurl.com/rqmjc2a Content: The revised death model Reaching a new level of contempt for CNN coverage Sean Hannity wants armed protesters to reconsider Chinese drones being used by US law enforcement? Civil disobedience is coming and growing If you would like my channel to have a wider audience […]

The post Episode 956 Scott Adams: Come Sip the News appeared first on Scott Adams' Blog.

My new book LOSERTHINK, available now on Amazon https://tinyurl.com/rqmjc2a Content: Watching Anderson Cooper CNN is like being on mushrooms Why state governments are best for reopening decisions Disbanding the task force, it’s time Moonface Ben Shapiro’s clear description of coronavirus situation If you would like my channel to have a wider audience and higher production […]

The post Episode 957 Scott Adams: Let Me Tell You About the Psychedelic Mushroom I Accidentally Ingested Called CNN appeared first on Scott Adams' Blog.

My new book LOSERTHINK, available now on Amazon https://tinyurl.com/rqmjc2a Content: The coronavirus pandemic viewed through a Dilbert filter Victor David Hanson: “credentialed class” keeps getting it wrong My Twitter debate with a doctor, on testing feasibility Models function is to manipulate perception Paying to have airline middle seats empty If you would like my channel […]

The post Episode 958 Scott Adams: Grab Your Beverage and Buckle Up appeared first on Scott Adams' Blog.

My new book LOSERTHINK, available now on Amazon https://tinyurl.com/rqmjc2a Content: Making the most of our lockdown opportunities The future of the coronavirus task force Testing our way out, versus reality The economy and recovery If you would like to enjoy this same content plus bonus content from Scott Adams, including micro-lessons on lots of useful […]

The post Episode 959 Scott Adams: Join Me in My Fortress of Garagitude appeared first on Scott Adams' Blog.

My new book LOSERTHINK, available now on Amazon https://tinyurl.com/rqmjc2a Content: Is the record unambiguous…it was a coup attempt? Mind-readers confirm, Schiff is panicked Tim Graham’s visual writing style Ahmaud Arbery shooting The Plandemic video If you would like to enjoy this same content plus bonus content from Scott Adams, including micro-lessons on lots of useful […]

The post Episode 960 Scott Adams: Fake News, Bad Math, Bad Mind-Reading, Bad Behavior in the News appeared first on Scott Adams' Blog.

My new book LOSERTHINK, available now on Amazon https://tinyurl.com/rqmjc2a Content: There WAS…a genuine coup attempt Governor Abbott’s Coronavirus strategy CNN promotes their choice for Biden’s VP Hoaxes, hoaxes and hoaxes Vitamin D and groups vulnerable to coronavirus If you would like to enjoy this same content plus bonus content from Scott Adams, including micro-lessons on […]

The post Episode 961 Scott Adams: Flynn, Freedom, Vitamin D, Biden’s Brain and More appeared first on Scott Adams' Blog.

My new book LOSERTHINK, available now on Amazon https://tinyurl.com/rqmjc2a Content: The Plague of Corruption video General Flynn San Antonio makes phrase “Chinese virus” hate speech Vitamin D deficiency and coronavirus Testing, flattening the curve, magical thinking If you would like to enjoy this same content plus bonus content from Scott Adams, including micro-lessons on lots […]

The post Episode 962 Scott Adams: No One Knows Anything But We Still Have to Decide How to reopen Economy appeared first on Scott Adams' Blog.

My new book LOSERTHINK, available now on Amazon https://tinyurl.com/rqmjc2a Content: The Vitamin D potential for reducing risk of coronavirus Ted Cruz continues to impress and entertain General Flynn coverage contrast, FOX versus CNN Nate Silver’s coronavirus analysis insights Press Secretary Kayleigh McEnany’s zingers If you would like to enjoy this same content plus bonus content […]

The post Episode 963 Scott Adams: Reviewing the Two Movies of Reality and the New Press Secretary’s First Days appeared first on Scott Adams' Blog.

My new book LOSERTHINK, available now on Amazon https://tinyurl.com/rqmjc2a Content: Adam Schiff lied for years…but broke no laws We do NOT know if Russia hacked DNC? Law enforcement targeted/framed President Trump to take him out “Cheryl The Server” theory applied to the lockdown If you would like to enjoy this same content plus bonus content […]

The post Episode 964 Scott Adams: Grab Your Beverage Because it’s Time For… appeared first on Scott Adams' Blog.

American Express has

Payment service provider and direct card acquirer ECOMMPAY have...

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

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

A new study has conducted a preliminary investigation into the design of reserves that would help protect coral reefs from climate change. The results indicate that, 15 per cent of coral reefs in the Bahamas, the study area, would be able to withstand rising temperature, and would therefore be appropriately placed in reserves.

Adopting the Green Economy approach will reap greater environmental, social and economic benefits, compared with a society that focuses on economic growth as the measure for future development, according to a recent UN report. Using two per cent of global GDP to ???green??? key sectors could be enough to trigger the transition towards a green economy.

Populations of organisms that live on the bottom of an aquatic ecosystem, the benthic community, can be assessed to determine the health of the ecosystem. New research explores the many existing methods for assessing benthic communities to ensure that the most appropriate and useful tests are used under the Water Framework Directive (WFD).

Science for Environment Policy are very pleased to announce the launch of a new series of policy briefs. Entitled 'Future Briefs', these will explore emerging areas of research with implications for environmental policy.'Plastic Waste: redesign and biodegradability' is the first Future Brief, which will be published week commencing 27 June. Future Briefs will be available to download free from our website: http://ec.europa.eu/environment/integration/research/newsalert/index_en.htm

A recent study suggests that a single integrative assessment of marine fisheries can be used to monitor progress against several different marine environmental policies. It used a relative ecological risk model to demonstrate how closing marine protected sites to trawlers and reducing trawling to maximum sustainable yield (MSY) levels would allow fisheries to meet the ecological objectives of both the Marine Strategy Framework Directive and the Habitats Directive.

Scientists involved in a pan-European project to develop better methods of risk assessment say maps that show such cumulative risks geographically are easy to interpret and should be considered as practical tools for conveying risk information to decision makers and the general public.

Urban vegetation could have been overlooked as valuable above-ground carbon storage, according to researchers. They estimated that 231,521 tonnes of carbon were stored in above-ground vegetation in a UK city, the majority of which (97 per cent) in trees. This was 10 times the amount estimated from national figures for the same city area.

A new Spanish study has highlighted current developments in the tourism sector that have significant implications for water supply and demand, but are barely addressed in recent land use policies. The findings indicate that any tourist destination that is to follow the ???quality tourist??? model will have an increased water demand in domestic residential areas, which is one of the biggest threats to sustainable water management.

Hypoxia (low levels of oxygen) is widespread in the coastal waters of the Baltic Sea, according to recently published research. The trend of increasing hypoxia since the 1950 is alarming, although improvements can be seen in some areas as a result of measures to reduce inputs of organic material.

Using ???cool??? materials to construct roads and walkways is an effective way of lowering urban temperatures to make cities more comfortable in hot weather. According to a recent study, surface temperatures were reduced by 12??C and ambient temperatures were reduced by 1.9??C after cool pavements were installed in a city park in Greece.

A new analysis of how to encourage pro-environmental behaviour highlights four effective techniques: goal-setting, prompts or reminders, witnessing the behaviour of others and introducing new behaviours that correspond with existing beliefs.

City dwellers who grow their own fruit and vegetables may be consuming high levels of pollutants. In a recent study, researchers found that vegetables grown on plots in Berlin, Germany, often contained higher concentrations of some heavy metals than shop-bought vegetables, with those grown close to busy roads containing the greatest quantities.

A recent study has assessed the costs and effectiveness of reducing phosphorus pollution for lakes in Scotland, UK, to achieve good ecological status as required by the EU???s Water Framework Directive (WFD). It was found that phosphorus in 72% of the lake area in Scotland could be mitigated at a cost of ??5.7 million (???7 million) per year, which is considered a proportionate or reasonable cost given the resulting social benefits.

A new tool has been developed, with input from the public, to measure and compare the quality of green spaces in urban areas. A UK case study suggests that litter and vandalism are among the factors most likely to prevent local residents from using and benefiting from green spaces.

The last two decades have seen a series of new construction waste policies management in Hong Kong. One of the most significant is an offsite construction waste sorting (CWS) programme which, since its implementation in 2006, has separated 5.11 million tonnes of construction waste into different materials. The researchers suggest that the study provides an important reference for other countries working to minimise construction waste.

A standardised method to help choose the most cost-effective measures to remediate contaminated sites has been developed by Austrian researchers. The method takes into account a wide range of factors, including the principles of sustainability.

Researchers in Berlin have demonstrated that urban wasteland areas can be used as suitable habitats for a range of grassland species. Using simple and cost-effective measures to sow grassland seed mixtures, they found that such areas flourished despite poor soil conditions and high levels of impact from people.

A recent study has described a simple method to screen the toxicity of materials used in consumer products. Using utility meter products as examples, the study found, for example, that stainless steel and polyvinyl chloride (PVC) had high toxicity potentials and suggests less toxic, but equally effective and priced, alternatives that could be used instead.

Researchers have discovered high levels of plastic particles and fibres, as well as black carbon (BC), which is formed by the incomplete burning of fossil fuels, in the waters of the Jade Bay, an inshore basin off the coast of Germany in the Southern North Sea. The concentration of suspended particles are of concern because they have the potential to be ingested by fish and other marine life, and enter the food chain.

A recent study has revealed how water use has changed across the world over the last 60 years. Growing populations and economic development, particularly in newly-emerging countries, have increased water demand, but technological developments have led to water efficiencies and savings, which moderate these demands.

Assessing the potential of new environmental management tools often brings an ???innovation dilemma???: is it better to stick with what is known to work, or to implement new measures that are potentially more effective, but also more uncertain? Researchers have proposed an approach to deal with these dilemmas, and applied it to the case study of an invasive species programme in the US.

A recent study has investigated how waste disposal sites in southern Italy have affected residents living nearby. Villagers reported being annoyed by odours, but the perceptions of residents living in the village closest to the facilities were possibly influenced by receiving financial compensation for the presence of the facilities.

Mediterranean red coral (Corallium rubrum), already endangered due to over-harvesting, is likely to suffer still further under increasing ocean acidification as a result of rising CO2 emissions. Research has shown that under more acidic conditions the structural development of red coral skeletons is abnormal and growth rate is reduced.

Researchers have developed a new model to assess the health-related external costs arising from air pollution from ten major emission sectors. Applying the model at national and Europe-wide levels, they suggested that the major contributors to costs were industrial power production, agriculture, road traffic and domestic combustion.

Green roofs can cool buildings in summer and prevent heat loss in winter. A new study suggests, however, that in the warm climates of southern Europe the additional cost of watering means that 'cool roof coatings??? may be more cost effective.

Covering walls with plants can significantly reduce the temperature of building walls during hot summer months. A recent study of three different types of these ???living walls??? in Italy suggests that they can be 20??C cooler than a bare wall on sunny days. An added advantage is that living walls can be retrofitted to existing buildings.