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When human expertise improves the work of machines

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Machine learning algorithms can sometimes do a great job with a little help from human expertise, at least in the field of materials science. In many specialized areas of science, engineering and medicine, researchers are turning to machine learning algorithms to analyze data sets that have grown too large for humans to understand. In materials science, success with this effort could accelerate the design of next-generation advanced functional materials, where development now usually depends on old-fashioned trial and error. By themselves, however, data analytics techniques borrowed from other research areas often fail to provide the insights needed to help materials scientists and engineers choose which of many variables to adjust -- and the techniques can't account for dramatic changes such as the introduction of a new chemical compound into the process. In a new study, researchers explain a technique known as dimensional stacking, which shows that human experience still has a role to play in the age of machine intelligence. The machines gain an edge at solving a challenge when the data to be analyzed are intelligently organized based on human knowledge of what factors are likely to be important and related. "When your machine accepts strings of data, it really does matter how you are putting those strings together," said Nazanin Bassiri-Gharb, the paper's corresponding author and a scientist at the Georgia Institute of Technology. "We must be mindful that the organization of data before it goes to the algorithm makes a difference. If you don't plug the information in correctly, you will get a result that isn't necessarily correlated with the reality of the physics and chemistry that govern the materials."

Image credit: Rob Felt/Georgia Tech




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Could graphene-lined clothing prevent mosquito bites?

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A new study shows that graphene sheets can block the signals mosquitoes use to identify a blood meal, potentially enabling a new chemical-free approach to mosquito bite prevention. Researchers showed that multilayer graphene can provide a twofold defense against mosquito bites. The ultra-thin yet strong material acts as a barrier that mosquitoes are unable to bite through. At the same time, experiments showed that graphene also blocks chemical signals mosquitoes use to sense that a blood meal is near, blunting their urge to bite in the first place. The findings suggest that clothing with a graphene lining could be an effective mosquito barrier.

Image credit: Hurt Lab/Brown University




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Virtual 'UniverseMachine' sheds light on galaxy evolution

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How do galaxies such as our Milky Way come into existence? How do they grow and change over time? The science behind galaxy formation has long been a puzzle, but a University of Arizona-led team of scientists is one step closer to finding answers, thanks to supercomputer simulations. Observing real galaxies in space can only provide snapshots in time, so researchers who study how galaxies evolve over billions of years need to use computer simulations. Traditionally, astronomers have used simulations to invent theories of galaxy formation and test them, but they have had to proceed one galaxy at a time. Peter Behroozi of the university's Steward Observatory and colleagues overcame this hurdle by generating millions of different universes on a supercomputer, each according to different physical theories for how galaxies form. The findings challenge fundamental ideas about the role dark matter plays in galaxy formation, the evolution of galaxies over time and the birth of stars. The study is the first to create self-consistent universes that are exact replicas of the real ones -- computer simulations that each represent a sizeable chunk of the actual cosmos, containing 12 million galaxies and spanning the time from 400 million years after the Big Bang to the present day. The results from the "UniverseMachine," as the authors call their approach, have helped resolve the long-standing paradox of why galaxies cease to form new stars even when they retain plenty of hydrogen gas, the raw material from which stars are forged. The research is partially funded by NSF's Division of Physics through grants to UC Santa Barbara's Kavli Institute for Theoretical Physics and the Aspen Center for Physics.

Image credit: NASA/ESA/J. Lotz and the HFF Team/STScI




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Why These 2 Investment Professionals Say This Telemedicine Company Is One of Their Top Picks

Source: Streetwise Reports   04/28/2020

As the coronavirus pandemic has accelerated the move to telemedicine, two investment professionals are following CloudMD, a small cap rapidly expanding in Canada.

News Flash: On May 7, CloudMD announced that it is partnering with IDYA4 Corp. for it to resell the health technology firm's Livecare technology in the U.S.. Read more here.

News Flash: On May 4, CloudMD announced that it is partnering with Save-On-Foods grocery stores and Pure Integrative Pharmacy to pilot on demand, integrated virtual patient care through telemedicine kiosks placed in pharmacies' existing consult rooms. Read more here.

As people are avoiding going to doctor's offices and hospitals during the coronavirus pandemic, telemedicine has taken off. Two investment professionals, Bruce Campbell and Keith Schaefer, have called CloudMD Software & Services Inc. (DOC:CSE; DOCRF:OTCQB; 6PH:FSE), a small-cap Canadian telemedicine firm, a top pick.

Bruce Campbell, founder and portfolio manager of Stonecastle Investment Management, spoke about CloudMD on April 27 on BNN:

"The first top pick is CloudMD Software, a technological medical play. We've tried to look at opportunities that are really going to be able to take advantage of Covid and this is one of the ones that we think is; what they do is telemedicine.

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

If you look back at a year ago, where everyone had to go to the doctor, and now all of the different provinces have opened up billing codes, so that now we don't have to go into a doctor's office. We can do a virtual doctor's visit and the doctor gets paid just like they do with an in-house appointment. Obviously with everything that has happened with this crisis, people really don't want to go into a doctor's office and they need a prescription renewal or something like that.

If you look at CloudMD's peers in the U.S., there is a company called Teladoc, which is a big U.S. company that does the same thing. Obviously, the size of the market is different, but the multiple it trades at is multiple times higher than where CloudMD is.

CloudMD is just starting to gain adoption. They started off here in BC, they have moved to Ontario, and they are going to be rolling out really across the country, so tons of opportunity for a company like this. They will probably change the way that we view our doctor and our healthcare visits going forward."

Keith Schaefer, editor and publisher of Oil & Gas Investments Bulletin, is also following CloudMD, and wrote:

"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.

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. 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.

The market desperately wants to own TeleHealth right now. 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.

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 & 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.

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 healthcare 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. 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!

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

Read Keith Schaefer's entire article here.

Watch Bruce Campbell of StoneCastle Investments share his top picks: CloudMD, Lightspeed and Viemed.

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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. An affiliate of Streetwise Reports is conducting a digital media marketing campaign for this article on behalf of 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.

Additional Disclosures

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.

Bruce Campbell, Stonecastle Investment Management:
A guest firm/affiliate holds a position in CloudMD. There is no guest position held, members of his household do not hold positions and CloudMD is not an investment banking client.

( Companies Mentioned: DOC:CSE; DOCRF:OTCQB; 6PH:FSE, )




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BARDA Award Provides 'Lift-off for Biotech's COVID Vaccine'

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, )




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Avadel Shares Rise and Shine on Positive Phase 3 Narcolepsy Study Findings

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, )




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Stemline Shares Take Off on $677 Million Buyout Offer by Global Pharmaceutical Firm

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, )




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California Biotech Partners for Manufacture of COVID-19 Vaccine Candidate

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.
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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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