Moderna CEO Stéphane Bancel joins Yahoo Finance’s Alexis Christoforous, Brian Sozzi, and Anjalee Khemlani to discuss the company’s entry into the Phase 3 trial of its COVID-19 vaccine, and what to expect.
Moderna, Inc. (Nasdaq: MRNA), a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced a modification to its contract with the Biomedical Advanced Research and Development Authority (BARDA) for an additional commitment of up to $472 million to support late stage clinical development including the expanded Phase 3 study of the Company’s mRNA vaccine candidate (mRNA-1273) against COVID-19.
An earlier award from BARDA for up to $483 million was entered into to support the scale up of mRNA-1273 and clinical development, originally with a smaller anticipated number of participants in the Phase 3 clinical trial. Following discussions with the U.S. Food and Drug Administration (FDA) and consultations with Operation Warp Speed over the past several months, the Company has decided to conduct a significantly larger Phase 3 clinical trial, leaving a gap in BARDA funding that will be closed by this contract modification. Under the terms of the revised contract, BARDA is expanding their support of the Company’s late stage clinical development of mRNA-1273, including the execution of a 30,000 participant Phase 3 study in the U.S. The total value of the award is now approximately $955 million.
“We thank BARDA for this continued commitment to mRNA-1273, our vaccine candidate against COVID-19.” said Stéphane Bancel, Moderna’s Chief Executive Officer. “Encouraged by the Phase 1 data, we believe that our mRNA vaccine may aid in addressing the COVID-19 pandemic and preventing future outbreaks.”
ClinicalTrials.gov identifier is NCT04470427.” data-reactid=”27″ type=”text”>The Phase 3 COVE study is being conducted in collaboration with National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and is expected to begin tomorrow, July 27. The Phase 3 study protocol has been reviewed by the U.S. Food and Drug Administration (FDA) and is aligned to recent FDA guidance on clinical trial design for COVID-19 vaccine studies. The randomized, 1:1 placebo-controlled trial is expected to include approximately 30,000 participants at the 100 µg dose level in the U.S. The primary endpoint will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease (as defined by the need for hospitalization) and prevention of infection by SARS-CoV-2. The ClinicalTrials.gov identifier is NCT04470427.
Moderna is working closely with Operation Warp Speed and the NIH, including NIAID’s COVID-19 Prevention Trials Network (CoVPN), to conduct the Phase 3 COVE study. Working together with collaborators like NIH, the Company hopes to achieve a shared goal that the participants in the COVE study are representative of the communities at highest risk for COVID-19 and of our diverse society.
strategic collaboration with Lonza. In addition, Moderna recently announced a collaboration with Catalent for large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent’s biologics facility in Indiana. Initial funding of $1.3 billion for Moderna to begin producing mRNA-1273 supply at-risk was secured from investors in the Company’s most recent public equity offering in May 2020.” data-reactid=”29″ type=”text”>The Company remains on track to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year, beginning in 2021 from the Company’s internal U.S. manufacturing site and strategic collaboration with Lonza. In addition, Moderna recently announced a collaboration with Catalent for large-scale, commercial fill-finish manufacturing of mRNA-1273 at Catalent’s biologics facility in Indiana. Initial funding of $1.3 billion for Moderna to begin producing mRNA-1273 supply at-risk was secured from investors in the Company’s most recent public equity offering in May 2020.
BARDA is part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services. This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. 75A50120C00034.
prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from the VRC. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the FDA granted mRNA-1273 Fast Track designation. Both cohorts, healthy adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300), in the Company’s Phase 2 study of mRNA-1273 are fully enrolled. A summary of the company’s work to date on COVID-19 can be found here.” data-reactid=”32″ type=”text”>mRNA-1273 is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from the VRC. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the FDA granted mRNA-1273 Fast Track designation. Both cohorts, healthy adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300), in the Company’s Phase 2 study of mRNA-1273 are fully enrolled. A summary of the company’s work to date on COVID-19 can be found here.
Moderna scientists designed the company’s prophylactic vaccines modality to prevent infectious diseases. More than 1,900 participants have been enrolled in Moderna’s infectious disease vaccine clinical studies under health authorities in the U.S., Europe and Australia. Clinical data demonstrate that Moderna’s proprietary vaccine technology has been generally well-tolerated and can elicit durable immune responses to viral antigens. Based on clinical experience across Phase 1 studies, the company designated prophylactic vaccines a core modality and is working to accelerate the development of its vaccine pipeline.
The potential advantages of an mRNA approach to prophylactic vaccines include the ability to combine multiple mRNAs into a single vaccine, rapid discovery to respond to emerging pandemic threats and manufacturing agility derived from the platform nature of mRNA vaccine design and production. Moderna has built a fully integrated manufacturing plant which enables the promise of the technology platform.
nine development candidates in its prophylactic vaccines modality, including:” data-reactid=”40″ type=”text”>Moderna currently has nine development candidates in its prophylactic vaccines modality, including:
Respiratory syncytial virus (RSV) vaccine for older adults (mRNA-1777 and mRNA-1172 or V172 with Merck)
RSV vaccine for young children (mRNA-1345)
Human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3) vaccine (mRNA-1653)
COVID-19 vaccine (mRNA-1273)
Influenza H7N9 (mRNA-1851)
Cytomegalovirus (CMV) vaccine (mRNA-1647)
Zika vaccine (mRNA-1893 with BARDA)
Epstein-Barr virus (EBV) vaccine (mRNA-1189)
To date, Moderna has demonstrated positive Phase 1 data readouts for eight prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus, hMPV/PIV3, CMV, Zika and COVID-19). Moderna’s CMV vaccine is currently in a Phase 2 dose-confirmation study. Moderna’s investigational Zika vaccine (mRNA-1893), currently in a Phase 1 study, was granted FDA Fast Track designation in August 2019.
Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases. The company’s platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, providing Moderna the capability to pursue in parallel a robust pipeline of new development candidates. Moderna is developing therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and cardiovascular diseases, independently and with strategic collaborators.
www.modernatx.com.” data-reactid=”58″ type=”text”>Headquartered in Cambridge, Mass., Moderna currently has strategic alliances for development programs with AstraZeneca PLC and Merck & Co., Inc., as well as the Defense Advanced Research Projects Agency (DARPA), an agency of the U.S. Department of Defense, and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). Moderna has been ranked in the top ten of Science’s list of top biopharma industry employers for the past five years. To learn more, visit www.modernatx.com.
www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna’s current expectations and speak only as of the date hereof.” data-reactid=”60″ type=”text”>This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding the Company’s development of a potential vaccine against the novel coronavirus, the parameters and timing of the P
Drugmaker Moderna (MRNA) – Get Report, one of the front-runners to producing a viable coronavirus vaccine, fell on Monday after Oxford University and AstraZeneca (AZN) – Get Report published promising data from an early stage trial of a key coronavirus vaccine study and the stock received a downgrade from J.P. Morgan.
In a study published on Monday, Oxford and AstraZeneca’s coronavirus vaccine trial showed “potent” cellular and humoral immunogenicity in all 1,077 participants in a Phase 1/Phase II study.
That, combined with an unrelated downgrade from J.P. Morgan analyst Cory Kasimov to neutral from overweight, pushed shares of Moderna lower. The stock was down 10.12% at $85.25 in trading on Monday.
Moderna stock has surged in recent months as various studies of its coronavirus vaccine candidate, mRNA-1273, have shown promising results in various clinical trials.
Moderna’s vaccine has shown to produce coronavirus antibodies in trials, federal researchers said last week, something National Institute of Allergy and Infectious Diseases’ head Dr. Anthony Fauci has called “really quite promising.”
At the same time, Moderna is one of hundreds of companies seeking an effective vaccine, with no resolute proof that it has the recipe for success. More than 20 vaccine hopefuls are in human testing, and another 130 are in earlier phases of development, according to the World Health Organization.
Moderna, which is applying similar technology as Pfizer (PFE) – Get Report and BioNTech (BNTX) – Get Report to develop a vaccine, received fast-track approval from the Food and Drug Administration for its Covid-19 vaccine candidate in May.
For its part, Moderna will begin a Phase 3 trial on July 27 that is expected to include some 30,000 participants. The participants will help compare its vaccine with placebo injections of the vaccine and determine whether it continues to show a buildup of antibodies needed to fend off the coronavirus.
Moderna has been focused on testing a vaccine that will not only prevent infection from SARS-CoV-2, the virus that causes Covid-19, but also prevent severe cases of the disease that require hospitalization.
Moderna’s phase 1 data looks positive, but the company’s investigational coronavirus vaccine has a lot more to prove in late-stage trials.
Moderna(NASDAQ:MRNA) has taken another step closer to making its dream of commercializing a coronavirus vaccine a reality. The company just released more detailed interim results from its phase 1 trial — and they are enough for Moderna and investors to cheer about.
What’s so encouraging about the results? And do they really bring Moderna close to victory? Let’s take a look.
Image source: Getty Images.
Moderna’s trial included 45 healthy volunteers ranging from 18 to 55 years old. Each participant was given two doses of mRNA-1273 28 days apart in one of three dosage levels. Based on the results, Moderna chose to pursue the 100-microgram dose — the mid-range dose — in late-stage trials.
Neutralizing antibody levels
The key positive in the phase 1 data has to do with neutralizing antibodies. These are the antibodies that actually block infection, so the ability of a vaccine to stimulate their production is crucial. Moderna, in a publication in The New England Journal of Medicine, reported that all evaluated trial participants showed neutralizing antibody production. And in the 100-microgram dosage group, levels were four times higher than those seen in recovered COVID-19 patients.
Initial data released in May only showed neutralizing antibody data for eight trial participants. While the neutralizing antibody levels came in at or above those of patients who had suffered from COVID-19, the sample wasn’t big enough to demonstrate a clear trend. This latest report of neutralizing antibody production in all participants is a big step forward. Results also showed T-cell responses following the second dose in the lower-dosage group and in the 100-microgram dose. T cells are another important piece of the puzzle as they are an immune system tool to detect and fight infection.
Moderna will aim to replicate that positive data in as many as 30,000 people when the company begins phase 3 studies on July 27.
A step closer to the finish line
All of this is good news for Moderna. The biotech company has taken a step closer to the finish line. But others have been catching up. Moderna isn’t as far ahead as it was several weeks ago.
AstraZeneca(NYSE:AZN) is conducting a phase 2/3 trial now. The U.S. Food and Drug Administration recently granted the Pfizer(NYSE:PFE) and BioNTech(NASDAQ:BNTX) team Fast Track designation for two vaccine candidates. Pfizer and BioNTech, like Moderna, are developing a vaccine using messenger RNA. They aim to begin a phase 2b/phase 3 trial in 30,000 participants later this month. Moderna, AstraZeneca, and the Pfizer and BioNTech team are among a handful of drugmakers closest to the finish line right now.
Inovio Pharmaceuticals(NASDAQ:INO) and Novavax(NASDAQ:NVAX) are close behind. Inovio plans to begin a phase 2/3 study this summer, and Novavax expects to release phase 1/2 interim data at the end of this month and then begin the phase 2 part of the study shortly thereafter.
Of course, that list of “who is ahead” is all from a timeline perspective. What, ultimately, is most important — and will determine the winner or winners — is the safety and efficacy of the vaccine candidate. Though Moderna’s results are encouraging, we still should rein in excitement.
Here’s why: First there’s the question of neutralizing antibodies. It’s still not clear how long neutralizing antibodies will remain in the body and what level of antibodies is needed to prevent infection. Another question is the vaccine’s performance in the elderly, a group heavily hit by COVID-19. A successful vaccine must be safe and effective in this population. Moderna is testing the vaccine in older and elderly volunteers in phase 2 and will also include these groups in phase 3.
What does this mean for investors?
Moderna shares have climbed 315% since the start of the year. The company doesn’t yet have products on the market. Besides the COVID-19 vaccine, Moderna’s most advanced candidate is in phase 2 studies. That means if Moderna’s vaccine fails, the company is still years away from commercializing a product.
In the near term, with any good news, this biotech stock likely has more to gain. And if Moderna’s vaccine is successful, the shares may skyrocket. But if the company loses this race or produces a vaccine that isn’t as strong as a rival’s, the result may be devastating for the shares. That’s why, for now, long-term investors may want to watch Moderna’s final sprint to the finish from the sidelines.
Adria Cimino has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.
Washington (AFP) – US biotech firm Moderna said Tuesday it would enter the final stage of human trials for its COVID-19 vaccine on July 27, to test how well it protects people in the real world.
The announcement came as the results from an earlier trial intended to prove the vaccine was safe and triggered antibody production were published.
The upcoming Phase 3 trial will recruit 30,000 participants in the US, with half to receive the vaccine at 100 microgram dose levels, and the other half to receive a placebo.
Researchers will then track them over two years to determine whether they are protected against infection by the virus. Or, if they do get infected, whether the vaccine prevents symptoms from developing.
If they do get symptoms, the vaccine can still be considered a success if it stops severe cases of COVID-19.
The study should run until October 27, 2022, but preliminary results should be available long before.
The announcement came shortly after the New England Journal of Medicine published results from the first stage of Moderna’s vaccine trial, which showed the first 45 participants all developed antibodies to the virus.
Moderna is considered to be in a leading position in the global race to find a vaccine against the coronavirus, which has infected more than 13.2 million people and killed 570,000.
But scientists caution that the first vaccines to come to market may not be the most effective or safest.
– Encouraging results –
Moderna had previously published “interim results” from the first stages of its trial, called Phase 1 in May.
The early results were called “encouraging” by Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, which is co-developing the vaccine.
But some in the scientific community said they would reserve judgment until they saw the full results in peer-reviewed form.
According to the paper, 45 participants were split into three groups to test doses of 25 micrograms, 100 micrograms and 250 micrograms.
They were given a second dose of the same amount 28 days later.
After the first round, antibody levels were found to be higher with higher doses.
Following the second round, participants had higher levels of antibodies than most patients who have had COVID-19 and gone on to generate their own antibodies.
More than half the participants experienced mild or moderate side effects, which is considered normal.
The side effects included fatigue, chills, headache, body ache and pain at the injection site.
Three participants did not receive their second dose.
They included one who developed a skin rash on both legs, and two who missed their window because they had COVID-19 symptoms, but their tests later returned negative.
Amesh Adalja, an infectious diseases specialist at Johns Hopkins University, said it was encouraging that the participants developed high levels of an advanced class of antibodies.
He added, however: “You have to be very limited in how much you can extrapolate from a phase one clinical trial, because you want to see how this works when a person is exposed to the actual virus.”
The Moderna vaccine belongs to a new class of vaccine that uses genetic material — in the form of RNA — to encode the information needed to grow the virus’s spike protein inside the human body, in order to trigger an immune response.
The spike protein is a part of the virus that it uses to invade human cells, but by itself the protein is relatively harmless.
The advantage of this technology is that it bypasses the need to manufacture viral proteins in the lab, helping to ramp up mass production.
No vaccines based on this platform have previously received regulatory approval.
Early work using this technology backfired by making hosts more, not less, susceptible to infection, David Lo, a professor of biomedical sciences at University of California Riverside told AFP.
“One of the things we certainly want to look out for is whether there is a long term effect where the immune response… potentially develops an immunologic tolerance which would actually be detrimental to protection,” he said.
Avolunteer receives a Covid-19 test vaccine injection. | Siphiwe Sibeko/AP Photo
An experimental coronavirus vaccine developed by Moderna provoked an immune response without major side effects in an early-stage clinical trial, scientists reported Tuesday in the New England Journal of Medicine.
The Phase I trial, conducted in partnership with the National Institute of Allergy and Infectious Diseases, enrolled 45 people who were given two doses of the vaccine in March and April. More than half ofparticipants developed mild side effects, including chills and body aches, and three did not receive the second vaccine dose.
The vaccine is the first developed by a U.S. company to publish clinical trial results. Moderna, which has received more than $500 million from the government to develop its shot, released partial results on 8 of the 45 trial participants in a press release in May.
What it means: Participants received either a low, medium or high dose of the vaccine. Those who in all three groups who received both shots eventually produced “high levels of neutralizing antibody activity” that may keep Covid-19 at bay, the scientists reported.The antibody levels were similar to those seen in people who recovered from coronavirus infections.
But wait: The development of the antibodies is not direct proof that the vaccine works. Determining that will require a final, Phase III clinical trial.
What’s next: Researchers began enrollingparticipants in a Phase II trial in late May to further study the vaccine’s safety and its ability to produce an immune response.
Moderna plans to start a Phase III trial on July 27 to determine whether the vaccine can prevent coronavirus infection. That trial — conducted with help from NIAID and the federal government’s Operation Warp Speed initiative — will eventually enroll 30,000 people.
New study shows ‘robust’ immune response to trial vaccine, Moderna says
Moderna Inc. stock skyrocketed in premarket trade Wednesday, after the biotech company said its coronavirus vaccine candidate produced a “robust” immune-system response in a larger group of people and the study will move to a decisive clinical trial in July.
Results published in The New England Journal of Medicine showed that a two-dose vaccination schedule induced the desired immune response in all 45 people evaluated, a larger group than in the preliminary data Moderna MRNA, +6.90%
released in May, and was generally safe and well-tolerated, the company said.
Shares of Moderna already rallied after-hours Tuesday. The company is a front-runner among several developing experimental COVID-19 vaccines.
The results “reaffirm the positive interim data” released back in May, Moderna said. The trial vaccine “induced rapid and strong immune responses against SARS-CoV-2,” the coronavirus that causes COVID-19.
No serious adverse effects were reported, but some that did occur, such as headaches and fatigue, were “generally transient and mild to moderate in severity,” the company said.
Moderna is evaluating whether the participants’ immune responses are lasting, with participants followed for one year.
A Phase 3 study will start this month “to demonstrate our vaccine’s ability to significantly reduce the risk of COVID-19 disease,” Moderna said. It added that it remained on track “to be able to deliver approximately 500 million doses per year, and possibly up to 1 billion doses per year” beginning in 2021.
Moderna last week said it had signed another manufacturing deal for the investigational vaccine, this time with Spain’s Laboratorios Farmacéuticos Rovi. As part of the race for a coronavirus vaccine, drugmakers have scaled up their vaccine candidates’ production to hasten the time that it would take to distribute a working vaccine.
The new details about Moderna’s vaccine candidate emerged as Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said he was “cautiously optimistic” about a coronavirus vaccine relatively soon.
“We are in a pretty good place when it comes to a vaccine,” Fauci said at an event late Tuesday. “If things work out the way we hope they do,” a safe and effective vaccine would be ready for distribution by late 2020, beginning of 2021, he said. “I’m cautiously optimistic about that.”
Assuming that timetable is correct, the companies racing to develop a vaccine have promised that many doses will be available right away, Fauci said.
Shares of Moderna have nearly quadrupled this year, contrasting with losses around 1% and 7% for the S&P 500 index SPX, +0.90%
and the Dow Jones Industrial Average DJIA, +0.85%
in the same period.
(Reuters) – Biotech firm Moderna Inc could reap tens of billions of dollars in sales and stock appreciation if it wins the race for a COVID-19 vaccine. If it loses, the early-stage company’s value could crash.
FILE PHOTO: A sign marks the headquarters of Moderna Inc, which is developing a vaccine against the coronavirus disease (COVID-19), in Cambridge, Massachusetts, U.S., May 18, 2020. REUTERS/Brian Snyde
In the meantime, the firm’s chief executive is pocketing millions of dollars every month by selling shares that have tripled in price on news of Moderna’s development progress, a Reuters analysis of corporate filings shows. The sales – by CEO Stéphane Bancel, his childrens’ trust and companies he owns – amount to about $21 million between January 1 and June 26, including $6 million in May.
The company’s chief medical officer, Tal Zaks, has cashed out the majority of his available stock and options, netting over $35 million since January, the filings show.
The lucrative liquidations highlight the unusually powerful incentives for biotech executives to highlight development milestones for drugs that often never get approved or sold, according to interviews with seven executive-compensation experts. Optimistic corporate statements on coronavirus vaccines, they said, could cause investors to overpay for company shares or create false hope among the public and health officials seeking new weapons to fight the pandemic.
Bancel set a fixed schedule for his share sales – known as a 10b5-1 plan – long before the pandemic hit. Such executive share-sale plans are meant to guard against insider trading, avoiding the potential for executives to sell in advance of bad news they know is coming, or to put off selling until after a positive announcement.
Zaks sharply increased the pace of his sales with a new plan he put in place on March 13. That was three days before Moderna announced it had dosed the first human with a vaccine candidate, news that sent its stock price up 24% and signaled that future development milestones might push the shares higher.
The sales give the firm’s executives an unusual opportunity to lock in big profits on what could be fleeting market optimism, said Jesse Fried, a Harvard Law School professor who wrote a book about executive compensation.
“This may be their one shot at making a boatload of money if the vaccine doesn’t work out,” Fried said. Executives have wide discretion in releasing information, he said, and Moderna’s chiefs have a powerful motivation to “keep the stock price up.”
Reuters found no evidence that Bancel, Zaks or Moderna has exaggerated the company’s vaccine progress.
Many news outlets have reported sales by Moderna executives in the wake of positive news on its vaccine efforts. Reuters is the first to report that Bancel and affiliated entities are selling 90,000 shares every month and that Zaks moved to sharply increase his sales in March, three days before Moderna released market-moving news.
A Moderna spokesman said that Bancel is liquidating only a small portion of his holdings and that “substantially all of his family’s assets remain invested in Moderna.” This stakeholding reflected Bancel’s “long-term commitment” to the firm, the spokesman said. Bancel, his companies and his children’s trust own more than 24 million Moderna shares, making him the second largest stockholder, owning about 8% of the firm, down slightly from the beginning of the year.
Zaks did not respond to requests for comment, and Moderna did not comment on his share sales.
The high frequency, volume and profits of Bancel’s transactions – at about 90,000 shares monthly – are unique among the CEOs of 26 companies identified by Reuters as developing COVID-19 vaccines or treatments and that regularly publish information on executive trades of company shares.
Twenty-one of the firms have seen their stock rise since the end of January, just before coronavirus spread globally, and ten of those, including Moderna, have seen share prices at least double. But just four of the CEOs of those firms, including Bancel, have sold company stock. Only one – Chad Robins of Adaptive Biotech – made substantial, regular sales under a 10b5-1 plan, like Moderna’s Bancel. Adaptive Biotech, however, has seen a far smaller recent stock-price increase – about 50% – than Moderna. During May and June, Robins sold about $12 million in stock after Adaptive’s stock price rose on news that it is researching antibody therapies and a coronavirus test that delivers faster results.
Adaptive Biotech declined to comment and referred to a company filing that said Robins sold the stock to diversify his investments.
Most of Bancel’s sales have been carried out through plans in place since December 2018, the filings show. The transactions started in November 2019, when a trust belonging to his children began selling 11,046 shares each week. This January, Bancel and two companies he controls started selling stock regularly. Since then, they have collectively sold about 90,000 Moderna shares each month.
HIGH RISKS, REWARDS
Such scheduled sales are more common at early-stage biotech companies such as Moderna – which face intense risk-reward scenarios – than at more established and diversified drug firms, where executives frequently hold their equity until they leave the company.
Executives’ ongoing sales are an effective hedge against the bigger downside risk faced by companies like Moderna. Based in Cambridge, Massachusetts, the firm has more than 20 therapies and vaccines in development – but none near approval. Investors view the firm as a frontrunner in creating a COVID-19 vaccine, but it faces 17 serious competitors with candidates in clinical evaluations and 129 others in earlier development stages, according to the World Health Organization. Only a very small number of companies are expected to get vaccines to market, biotech executives and health experts say.
If Moderna successfully launches its coronavirus vaccine and a dozen other of its most promising trial medicines, its stock price could rise to $279 based on the new revenues, according to Morgan Stanley analysts. That would yield Bancel a fortune of about $10 billion including currently unvested share options, the Reuters analysis shows.
The firm’s stock has soared from $18 in late February – just before it announced it had shipped its vaccine candidate to the U.S. government for trials – to close at $56.57 on July 2, down 5%, after a report that the start of its large vaccine trial would be delayed. That gives the company a market capitalization of nearly $23 billion. The stock hit a high of $80 in May.
But Morgan Stanley also has a “bear case,” in which the company would be worth only as much as the cash on its balance sheet if all of its vaccine and drug candidates don’t make it to market.
‘SCIENCE BY PRESS RELEASE’
Bancel and Zaks have been bullish on Moderna’s prospects in public statements.
Bancel calls the mRNA technology the company uses for all vaccine development the “software of life,” with potential to create “a new class of medicines.” He has also said Moderna’s process can create vaccines much faster and with a better chance of “technical success” – and, by implication, regulatory approval – than other firms.
“We are not aware of anybody else who can do this at this scale, with this focus, at this speed,” he told investors on June 2. Earlier, in a May 7 earnings call, Bancel said he had “never been as excited and optimistic about the future of Moderna.”
Many investors and analysts are optimistic as well but say it is difficult to evaluate Moderna’s prospects given the early stages of trials.
The company drew criticism from scientists for releasing incomplete data from a trial being conducted by the U.S. National Institutes of Health (NIH). On May 18, Moderna announced that its vaccine candidate had produced protective antibodies in a small subset of healthy trial volunteers. The news pushed Moderna stock up 20% to its peak of $80.
Some scientists suggested Moderna should have held off publishing until it had all test subjects’ results. “This was science by press release,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia. Without complete data, he said, “you’re left to read the tea leaves.”
Dr. Anthony Fauci – the nation’s top infectious disease expert – shared the test results with U.S. governors, Vice President Mike Pence said in a Twitter post the day of Moderna’s announcement. But Fauci – who is running the Moderna trial – later said he didn’t like the company’s early release of incomplete data, according to an interview published by the STAT health news service. A spokeswoman for Fauci’s agency, the National Institute of Allergy and Infectious Diseases, did not comment beyond what Fauci said in the interview.
Bancel told investors at a June conference that Moderna’s leadership worried the information had been seen by too many people, including at the NIH. He said the company made the partial findings public because it worried the data would get leaked – and it considered the incomplete results material information that all investors should receive at the same time. A company spokesman told Reuters the company believed it needed to release the information to comply with Securities and Exchange Commission rules.
The day after the May 18 announcement, Zaks sold 125,000 shares – netting him nearly $10 million – at a price of $78, up from $66 on the Friday before the Monday press release. Company filings show the sale was executed in accordance with the plan that Zaks put in place on March 13.
Reporting by Tom Bergin and Robin Respaut; Editing by Tom Lasseter and Brian Thevenot
CHICAGO (Reuters) – A series of studies in mice of Moderna Inc’s COVID-19 lent some assurance that it may not increase the risk of more severe disease, and that one dose may provide protection against the novel coronavirus, according to preliminary data released on Friday.
Prior studies on a vaccine for SARS – a close cousin to the new virus that causes COVID-19 – suggests vaccines against this type of virus might have the unintended effect of causing more severe disease when the vaccinated person is later exposed to the pathogen, especially in individuals who do not produce an adequately strong immune response.
Scientists have seen this risk as a hurdle to clear before vaccines can be safely tested in thousands of healthy people.
While the data released by the U.S. National Institutes of Allergy and Infectious Disease (NIAID) and Moderna offered some assurance, the studies do not fully answer the question.
“This is the barest beginning of preliminary information,” said Dr. Gregory Poland, an immunologist and vaccine researcher at the Mayo Clinic who has seen the paper, which has yet to undergo peer-review.
Poland said the paper was incomplete, disorganized and the numbers of animals tested were small.
The authors said they have submitted the work to a top-tier journal. Moderna’s vaccine is in midstage testing in healthy volunteers. Moderna said on Thursday it plans to begin final-stage trials enrolling 30,000 people in July.
In the animal studies, mice received one or two shots of a variety of doses of Moderna’s vaccine, including doses considered not strong enough to elicit a protective immune response. Researchers then exposed the mice to the virus.
Subsequent analyses suggest “sub-protective” immune responses do not cause what is known as vaccine-associated enhanced respiratory disease, a susceptibility to more severe disease in the lungs.
“Subprotective doses did not prime mice for enhanced immunopathology following (exposure),” Dr. Barney Graham of the Vaccine Research Center at NIAID and colleagues wrote in the manuscript, posted on the bioRxiv website.
Further testing suggested the vaccine induces antibody responses to block the virus from infecting cells.
The vaccine also appeared to protect against infection by the coronavirus in the lungs and noses without evidence of toxic effects, the team wrote.
They noted the mice that received just one dose before exposure to the virus seven weeks later were “completely protected against lung viral replication,” suggesting a single vaccination prevented the virus from replicating in the lungs.
“At first glance, it looks promising in inducing neutralizing antibody protection in mice,” Dr. Peter Hotez, a researcher at Baylor College of Medicine said in an email. He had not reviewed the paper in detail.
Poland, who was not involved with the research, said the paper leaves out “important parameters” that could help scientists judge the work.
“The results, such as they are presented, provide interesting data that are reassuring … This needs to be replicated and it needs to be peer-reviewed,” he said.
Reporting by Julie Steenhuysen; Editing by Bill Berkrot and David Gregorio