US-based fintech Namogoo will integrate incentive platform

Source: Streetwise Reports   04/22/2020

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.

Disclosure:
1) Doresa Banning compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. She or members of her household own securities of the following companies mentioned in the article: None. She or members of her household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.

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

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

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

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

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

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

( Companies Mentioned: MRNA:NASDAQ, )

Source: Streetwise Reports   05/04/2020

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%).

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

( Companies Mentioned: STML:NASDAQ, )

Source: Streetwise Reports   05/05/2020

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

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

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

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

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

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

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

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

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

Disclosure:
1) Stephen Hytha compiled this article for Streetwise Reports LLC and provides services to Streetwise Reports as an independent contractor. He or members of his household own securities of the following companies mentioned in the article: None. He or members of his household are paid by the following companies mentioned in this article: None.
2) The following companies mentioned in this article are billboard sponsors of Streetwise Reports: None. Click here for important disclosures about sponsor fees.
3) Comments and opinions expressed are those of the specific experts and not of Streetwise Reports or its officers. The information provided above is for informational purposes only and is not a recommendation to buy or sell any security.
4) The article does not constitute investment advice. Each reader is encouraged to consult with his or her individual financial professional and any action a reader takes as a result of information presented here is his or her own responsibility. By opening this page, each reader accepts and agrees to Streetwise Reports' terms of use and full legal disclaimer. This article is not a solicitation for investment. Streetwise Reports does not render general or specific investment advice and the information on Streetwise Reports should not be considered a recommendation to buy or sell any security. Streetwise Reports does not endorse or recommend the business, products, services or securities of any company mentioned on Streetwise Reports.
5) From time to time, Streetwise Reports LLC and its directors, officers, employees or members of their families, as well as persons interviewed for articles and interviews on the site, may have a long or short position in securities mentioned. Directors, officers, employees or members of their immediate families are prohibited from making purchases and/or sales of those securities in the open market or otherwise from the time of the interview or the decision to write an article until three business days after the publication of the interview or article. The foregoing prohibition does not apply to articles that in substance only restate previously published company releases.
6) This article does not constitute medical advice. Officers, employees and contributors to Streetwise Reports are not licensed medical professionals. Readers should always contact their healthcare professionals for medical advice.

Source: Streetwise Reports   05/06/2020

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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A new assessment tool has been developed to evaluate the sustainability initiatives of government departments. On its first application, in the UK???s Department of Work and Pensions, it identified a good mix of practice alongside areas for improvement. The authors suggest that this method could be used elsewhere to assess how well an organisation is embedding the principles of sustainable development into all aspects of its business.

Cities are key players in global greenhouse gas (GHG) emissions. A new World Bank study has proposed a three-stage plan for mitigating climate change at a local level. Its recommendations include improving urban infrastructure and encouraging lifestyle change, but most importantly, clarity in the way urban GHG inventories are calculated.

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Urban planning policy has had a powerful influence on the amount of green space in cities, according to a recent UK study. It found that a change in planning policy in 2000 led to a decline in urban green space in nine cities between 2001 and 2006, although the amount of green space in all but one of the cities studied has increased overall since 1991.

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Organisations are increasingly applying green business principles. According to a recent study, electronics manufacturing companies in Taiwan that practice green supply chain management (GSCM) have a better business performance than companies that do not. Those with a strong green marketing focus performed the best, successfully competing with their rivals.

As the development of nanomaterials increases, a recent study recommends combining life cycle analysis and risk assessment to improve our understanding of the potential environmental and human health impacts of products containing nanomaterials.

A recent study has compared the environmental impact of a range of building materials. Energy consumption, carbon dioxide emissions and water demand can all be reduced by switching to renewable sources of energy, improving technologies and promoting eco-friendly alternative materials.