Moderna chairman on the early results of a coronavirus vaccine trial

New York (CNN Business)Moderna’s stock price skyrocketed as much as 30% on Monday after the biotech company announced promising early results for its coronavirus vaccine. As ordinary investors piled in, two insiders were quietly heading for the exits.

Moderna’s chief financial officer and chief medical officer executed options and sold nearly $30 million of shares combined on Monday and Tuesday, SEC filings reviewed by CNN Business show.
The sales occurred after Moderna (MRNA) excited Wall Street before markets opened Monday by announcing encouraging vaccine trial results. Moderna’s market value swelled to $29 billion — even though the company has no marketed products.

    After spiking to as high as $87 on Monday, Moderna’s stock price has since retreated below $70 as medical experts have debated the importance of the early findings.
    The securities transactions were done through automated insider trading plans, known as 10b5-1 plans, that lay out future stock trades at set prices or on set dates.

    Lorence Kim, Moderna’s chief financial officer, exercised 241,000 options for $3 million on Monday, filings show. He then immediately sold them for $19.8 million, creating a profit of $16.8 million.
    In quest for vaccine, US makes 'big bet' on company with unproven technology
    The next day, Tal Zaks, Moderna’s chief medical officer, spent $1.5 million to exercise options. He immediately sold the shares for $9.77 million, triggering a profit of $8.2 million.
    Moderna said the sales were executed under 10b5-1 trading plans that were established in advance. “These transactions are executing automatically pursuant to these trading plans,” the company said.
    Although the fortuitous timing of the transactions may raise eyebrows, Charles Whitehead, professor at Cornell Law School, said the stock sales did not appear to raise any legal red flags.
    “On its face, there is nothing wrong with these trades,” Whitehead said. “It’s what a 10b5-1 plan is intended for, assuming the requirements are met.”
    These plans regulate when and how many shares company insiders, including directors and executives, are allowed to sell. The transactions are typically executed automatically, without the insiders taking any action.
    Kim, the CFO, also made stock sales prior to the vaccine news. On May 15, just days before the results were announced, Kim sold 20,000 shares of stock worth $1.3 million.

    Moderna’s stock has since retreated

    Andrew Gordon, director of research services at Equilar, said there would only be a “legal issue if they created or modified their 10b5-1 plan while in possession of material insider information.”
    “It’s not uncommon for insiders to sell shares they own, nor is it bad for them to capitalize on the current stock price,” Gordon said in an email.
    Moderna’s share price fell 10% to $71.67 on Tuesday after health website STAT reported that vaccine experts concluded the company did not release enough information to know how significant the Phase 1 findings are.
    By Thursday, Moderna finished at $67.05, down 16% from its Monday close.
    “It’ll look bad from a PR perspective if Moderna’s stock price starts to fall dramatically after all this trading,” Gordon said.
    Moderna shares did rebound 2% to $68.60 on Friday after Dr. Anthony Fauci, the nation’s top infectious disease expert, cheered the vaccine trial findings.
    “Although the numbers were limited, it was quite good news because it reached and went over an important hurdle in the development of vaccines,” Fauci said during a CNN town hall. That’s the reason why I’m cautiously optimistic about it.”

    ‘Optics are terrible’

    Moderna is one of the early frontrunners to develop a vaccine for Covid-19, which has killed more than 90,000 Americans. The biotech company’s vaccine produces neutralizing antibodies that bind to the virus and disable it from attacking human cells.
    Moderna said its trial vaccinated dozens of participants and measured antibodies in eight of them. All eight developed neutralizing antibodies to the virus at levels reaching or exceeding the levels seen in people who have naturally recovered from Covid-19, the company said.
    If future studies go well, Moderna has said its vaccine could be available to the public as early as January.

      Charles Elson, a corporate governance expert at the University of Delaware, said the Moderna stock sales underscore why he has always believed executives should not sell stock while they are at the company.
      “Even if it can be done legally, the optics are terrible because it shows you have a better place to put your money,” said Elson. “It shows a lack of confidence in your company going forward.”
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      Shot Roster: COVID-19 Vaccines In Human Trials

      The ongoing COVID-19 pandemic has sickened over 3.25 million people and has killed 233,014 people, according to data from Johns Hopkins University.

      A safe and effective vaccine against SARS-CoV-2 is necessary to stop the novel coronavirus from spreading. A number of drug companies and research organizations are working on a vaccine for COVID-19.

      According to the World Health Organization’s database, there are seven COVID-19 candidate vaccines in human testing and over 90 in preclinical evaluation.

      In this article, we present to you the COVID-19 vaccines that are currently in human trials – their stage of development, developers, expected time frame, etc.

      1. BioNTech’s BNT162

      BioNTech SE’s (BNTX) BNT162 vaccine program to prevent COVID-19 infection includes four vaccine candidates, each representing different mRNA formats and target antigens.

      The four vaccine candidates under the BNT162 vaccine program are in phase I/II trial in Germany. The dose-escalation portion of the phase I/II trial will include approximately 200 healthy subjects between the ages of 18 to 55. The second part of the study will enroll subjects with a higher risk for a severe COVID-19 infection.

      BNT162 is being jointly developed by BioNTech and Pfizer (PFE).

      During its earnings conference call on Apr.28, Pfizer said that initial data from the BNT162 vaccine trial is “expected in May-June, with a potential for emergency use or accelerated approval probably in October and onwards”.

      Pfizer and BioNTech plan to initiate trials for BNT162 in the United States upon regulatory approval, which is expected shortly.

      BioNTech is collaborating with Fosun Pharma to develop BNT162 in China, where the companies expect to conduct trials.

      2. University of Oxford’s ChAdOx1 nCoV-19

      ChAdOx1 nCoV-19, developed by the University of Oxford researchers, is under a phase I/II study in the UK in healthy adult volunteers aged 18-55 years.

      ChAdOx1 nCoV-19 vaccine is based on a nonreplicating engineered chimpanzee adenovirus vector, ChAdOx1.

      The trial is designed to enroll up to 1,102 participants, recruited across multiple study sites in Oxford, Southampton, London, and Bristol. Results from the trial are expected to be available by May 2021.

      Serum Institute of India is collaborating with Oxford University for the manufacture of the ChAdOx1 nCoV-19 vaccine.

      3. CanSino’s Ad5-nCoV

      CanSino Biologics Inc.’s recombinant novel coronavirus vaccine Ad5-nCoV is under phase II trial in healthy adults over 18 years of age in China.

      Ad5-nCoV, co-developed with Beijing Institute of Biotechnology and the Academy of Military Medical Sciences, is built upon CanSino’s adenovirus-based viral vector vaccine technology platform.

      The phase II trial is designed to enroll 500 participants. Results from the trial are expected to be available by January 2021.

      4. Inovio’s INO-4800

      INO-4800, being developed by Inovio Pharmaceuticals Inc. (INO) is a DNA vaccine candidate to protect against the novel coronavirus SARS-CoV-2.

      INO-4800 is under a phase I clinical trial in the U.S., and is fully enrolled with all 40 healthy volunteers. The interim immune responses and safety results from the trial are expected in late June.

      If all goes well as planned, INO-4800 will advance into phase II/III efficacy trial, which is planned to be potentially initiated this summer.

      INOVIO has partnered with Beijing Advaccine and the International Vaccine Institute to advance clinical trials of INO-4800 in China and South Korea, respectively.

      The Company has also secured funding from CEPI, the Bill & Melinda Gates Foundation, and the U.S. Department of Defense for the development of INO-4800.

      5. Wuhan Institute of Biological Products’ COVID-19 vaccine

      The COVID-19 vaccine being developed by Wuhan Institute of Biological Products Co. Ltd., a subsidiary of China National Pharmaceutical Group Co., Ltd. (Sinopharm), is an inactivated vaccine, which means it is made from inactivated forms of the virus SARS-CoV-2.

      According to reports, the inactivated COVID-19 vaccine has entered the phase II portion of a phase I/II trial in participants aged 18 to 60.

      In the phase I part of the trial, 96 persons have been administered the vaccine. “The vaccine has shown good safety so far and participants are still under observation”, reports Xinhua, the national news agency of China.

      6. Sinovac’s PiCoVacc

      PiCoVacc, being developed by Sinovac Biotech Ltd., is a purified inactivated SARS-CoV-2 virus vaccine candidate.

      This vaccine is under phase I portion of a phase I/II trial in China. The trial is designed to enroll a total of 744 participants – 144 at phase I and 600 at phase II.

      The results from the trial are expected to be available by August 2020.

      7. Moderna’s mRNA-1273

      Moderna Inc.’s (MRNA) mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA vaccine, under phase I testing in healthy adults in the U.S.

      The trial has completed enrollment of 45 healthy adult volunteers of ages 18 to 55 years and is assessing the safety, reactogenicity, and immunogenicity of mRNA-1273.

      The phase I trial is led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Full results from the study are expected by June 2021.

      Meanwhile, the Company has sought FDA clearance to initiate a phase II study of mRNA-1273 if supported by safety data from the phase I study.

      If all goes well, the Company plans to initiate a phase II trial of mRNA-1273 this quarter (Q2, 2020), and will enroll 600 healthy participants across two cohorts of adults ages 18-55 years and older adults ages 55 years and above.

      Subject to data from the phase I and phase II studies and discussions with regulators, the Company intends to begin a phase III study of its mRNA-1273 vaccine in the fall of 2020.

      Coalition for Epidemic Preparedness Innovations (CEPI) and the Biomedical Advanced Research and Development Authority (BARDA) are also funding the development of Moderna’s mRNA vaccine.

      *Johnson & Johnson’s COVID-19 vaccine candidate Ad26 SARS-CoV-2 is expected to enter human clinical trial by September 2020.

      When will a vaccine for COVID-19 be available?

      Vaccine development is a complex process and it usually takes 10 to 15 years under a traditional vaccine development model. However, there are exceptions. Say, for example, it took 4 fours to develop and get approval for a mumps vaccine that was first licensed in 1948, and in the case of the Ebola vaccine, which was approved in December 2019, it took 5 years.

      But given the urgent need to address the ongoing pandemic, a COVID-19 vaccine requires a much-shortened timeline, without compromising long-term safety and efficacy.

      With scientists, physicians, funders, and manufacturers coming together as part of an international collaboration, coordinated by the World Health Organization, many experts are optimistic that a COVID-19 vaccine could be available by the summer of 2021.

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