Good morning. Welcome to the release of the report Preparing for Future Products of Biotechnology, from the National Academies of Sciences, Engineering, and Medicine.

A profusion of biotechnology products is expected over the next five to 10 years, and the number and diversity of new products has the potential to overwhelm the U.S. regulatory system, says a new report from the National Academies of Sciences, Engineering, and Medicine.

Biotechnology has the potential to be a part of the solution in protecting forest trees against destructive pest and disease outbreaks

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   05/06/2020

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, )

American farmers’ noncompliance with rules intended to keep bugs from developing pesticide resistance could mean trouble for corn.

It’s one of the fastest-growing industries, and states across the U.S. have been eagerly courting the industry in the hopes of landing new manufacturing plant

Researchers are setting their sights to resurrecting passenger pigeons and woolly mammoths, but would it do more harm than good?

DARPA using biotechnology in an effort to boost the U.S.'s national defense.

Global cooperation, development of international relations, medical services exports, and government measures to support Russian business will be on the agenda of the fourth annual forum BIOTECHMED. REC JSC-General Partner forum.

Global cooperation, international relations development and export of medical services were part of the agenda of the IV annual International Forum BIOTECHMED (September 16-17, Gelendzhik, Russia), turning out the key topics of the Forum.

Systems and methods for use in playing biotic games having a biologically active material as a component. Various games that provide for one or more human players to interact with biologically active materials are disclosed. The game apparatus includes a replaceable cartridge having a chamber in which a biologically active component such as a single-celled organism or a biologically active compound is contained. A stimulus controller accepts instructions from a human user and provides a stimulus to the biologically active component. A response receiver accepts a signal indicative of a response of the biologically active component. A display is provided to display to the user information indicative of the response of the biologically active component, and a game score. A computer-based game controller includes a set of pre-defined rules of play that define a game and that comprise pre-defined rules of scoring for the game.

Shares of Fortress Biotech Inc. (FBIO) are rising over 17% in pre-market today, after the company announced that its partner company Oncogenuity Inc. has entered into an exclusive worldwide licensing agreement with Columbia University to develop novel oligonucleotides for the treatment of genetically driven cancers.

Read the latest on pharma/biotech news, Clinical Trial Results, FDA Calendar, Top Gainers, Recalls, Food Alert and more on RTTNews Biotechnology.

1. ICMR partners with Bharat Biotech International Limited for developing indigenous coronavirus COVID-19 vacc...  Zee News
2. Bharat Biotech to lead monoclonal antibodies project for Covid-19 therapy  The Financial Express
3. Bharat Biotech to lead project on monoclonal antibodies therapy for COVID-19  The New Indian Express
4. ICMR teams up with Bharat Biotech to develop Covid-19 vaccine  Times of India
5. CSIR approves project to develop human monoclonal antibodies that can neutralize COVID-19 in patients  Times Now
6. View Full coverage on Google News

ICMR teams up with Bharat Biotech to develop COVID-19 vaccine  The Financial ExpressView Full coverage on Google News

ICMR teams up with Bharat Biotech to develop Covid-19 vaccine  Times of IndiaView Full coverage on Google News

21 July 2014

1. Bharat Biotech to lead human monoclonal antibodies project  The Hindu
2. Bharat Biotech leads CSIR project to develop antibodies against Covid-19  Times of India
3. Bharat Biotech To Lead CSIR’s Project To Develop Human Monoclonal Antibodies For Covid-19 Therapy  Swarajya
4. Bharat Biotech to develop human antibodies for COVID-19 therapy  Telangana Today
5. Bharat Biotech vows human monoclonal antibodies to neutralise COVID-19 in 6 months  Mumbai Mirror
6. View Full coverage on Google News

OMEGA Diagnostics shares jumped 77 per cent after it announced it is part of the UK rapid test consortium working to jointly develop and manufacture an antibody test.

A BIOTECH veteran has hailed a Glasgow firm that claims to have discovered two separate potential treatments for Covid-19 patients for use before they are put on ventilators.

Therefore, an alternate therapeutic regimen for early deployment is critical, the vaccine-maker said in the statement.

The institute has a high-level bio-safety facility designated Biosafety Level 3 Agriculture with the ability to safely handle and study pathogens like highly pathogenic influenza viruses and the novel coronavirus.

This project brings together National Centre for Cell Science (NCCS), Pune; Indian Institute of Technology, Indore, and Gurgaon-based PredOmix Technologies in a collaborative mode for a public health emergency.

The death toll due to COVID-19 rose to 1,981 and the number of cases climbed to 59,662 in the country on Saturday, the Health Ministry said.

1. Bharat Biotech to lead human monoclonal antibodies venture  Microbioz India
2. Bharat Biotech to lead monoclonal antibodies project for Covid-19 therapy  The Financial Express
3. Bharat Biotech leads CSIR project to develop antibodies against Covid-19  Times of India
4. CSIR approves project to develop human monoclonal antibodies that can neutralize COVID-19 in patients  Times Now
5. Bharat Biotech to lead project on monoclonal antibodies therapy for COVID-19  The New Indian Express
6. View Full coverage on Google News

AstraZeneca will set up a R&D centre and an AI innovation centre in Shanghai, as well as create a $1bn fund that would invest in healthcare start-ups.

Scientific innovation, a conducive regulatory climate and increased globalisation of drug markets are driving an investment boom in biotechnology, with small companies and emerging markets shaking up the sector.

Global FDI in the biotechnology sector has witnessed year-on-year increase since 2015.

Praxis Precision Medicines has chosen Australia to be its Asia-Pacific headquarters and research and development (R&D) centre.

San Diego-based biotechnology company, Organovo Holdings (Organovo), has announced a tie up with a Melbourne research institute to help develop regenerative medicine in Australia.

A Chinese fund has invested A$45 million to accelerate the development and commercialisation of translational health and medical research outcomes from South Australia. The investment will enable researchers from the University of Adelaide, University of South Australia, the state’s hospitals and other institutions to develop proof of concept, undertake clinical trials, and bring new drugs and technologies to the global market.