• COVID-19 will rebound in the fall. This company is preparing now
  • Investors: Pay close attention to this leading-edge biotechnology company
  • Write down the name of this CRISPR company with “blockbuster” potential

Dear Reader,

In a strange twist of fate, it appears that COVID-19 has resurged in China, this time in Beijing. China declared success in controlling the outbreak in Wuhan, and yet here we are… an outbreak in Beijing, a massive, sprawling city of more than 20 million residents.

Hundreds of flights have been canceled, some schools have been closed, some neighborhoods and residential compounds have been quarantined, and the city is racing to test and contain the virus as quickly as possible.

And who is to blame for this sudden outbreak? Well, it isn’t a who but a what.

A fish. More specifically… a salmon. An imported salmon.

This is a story worthy of a detective novel. The culprit was traced to yet another wet market called Xinfadi, the site of more than 100 new COVID-19 infections. Hidden within the confines of the market, the virus was traced to a specific chopping board used by a seller of imported salmon.

It’s worth mentioning that there is no scientific proof that COVID-19 can be transmitted through a frozen salmon. What I want to know is… What was on the cutting board before the frozen fish?

The nation’s response, however? A national boycott of frozen salmon from Scandinavia.

I, for one, will continue to eat salmon. I’m confident this fish is not carrying COVID-19. It’s also fun to catch.

And we should remember one simple reality of highly transmissible airborne viruses. They cannot be stopped. The same is true for seasonal influenzas.

Even if we get the flu shot every year, we aren’t 100% protected. The best we can do is manage the spread safely until one of three things happens:

  • The virus continues to mutate, get weaker, and eventually fizzle out.

  • A population achieves herd immunity (usually ~60% of the population has to become infected).

  • A vaccine is developed to protect the majority of the population.

These aren’t mutually exclusive, as they can all occur in parallel. Regardless, at least one of these things needs to happen before we rid ourselves of COVID-19.

Now to our insights…

This COVID-19 treatment could be ready by the fall…

Earlier this month, we talked about how Eli Lilly is backing the first COVID-19 antibody therapy to make it into Phase 1 clinical trials.

As a reminder, an antibody therapy injects antibodies that are proven to be effective in fighting off a virus into patients.

And now Regeneron has become the second company to take a COVID-19 antibody therapy to clinical trials. In fact, Regeneron has two separate antibodies that it is combining to make an antibody cocktail.

Regeneron used the same rapid-response approach to develop these antibodies as it had for its Ebola virus antibody treatment. And because of this previous work, the Food and Drug Administration (FDA) will allow Regeneron to accelerate its clinical trials.

Regeneron will blend Phase 1, Phase 2, and Phase 3 testing over the next six to eight weeks. It is collecting Phase 1 safety data right now. And it is already planning its Phase 2 efficacy studies, which will commence soon.

The plan includes administering these antibodies to health care workers, who naturally have a higher risk of contracting COVID-19.

Regeneron will also treat volunteers who have high exposure to the virus but have not yet contracted it. That will include people living with family members who have come down with COVID-19.

This is a logical approach to testing. We would expect many of these volunteers to come down with COVID-19 if left untreated. If Regeneron’s cocktail therapy helps these patients build immunity, we should see very few of them contract the virus. That’s how we will know it works.

And, of course, Regeneron will be collecting data on patients’ immunity levels every step of the way. That’s how it will find the optimal dosage level for the therapy.

And here’s where it gets exciting…

If the clinical trials go well, Regeneron will likely receive emergency use authorization (EUA) from the FDA. That will allow Regeneron to offer its therapy to the public in time for autumn.

That’s important because we will likely see a second wave of COVID-19 cases when the weather gets cool and dry again. Those conditions are more conducive to the spread of the virus.

In all my years as an analyst, I’ve never seen this type of speed from the biotech industry. Typically, going through the various trials is a years-long process. But companies are now conducting trials in a matter of weeks. That gives us some idea about the sense of urgency behind these projects.

Of course, this is great news for Regeneron. And I’m happy to report my readers have personally profited. I recommended Regeneron (REGN) in the pages of my large-cap investing service, The Near Future Report, back in December.

That was before the company was plastered all over CNBC. Today, we’re up 60% in just six months. That’s the power of investing in great companies with industry-altering technology.

For readers who haven’t joined The Near Future Report, I extend an open invitation. See what I’m recommending next by going here.

Moderna’s synthetic vaccine for COVID-19 is progressing rapidly…

Speaking of COVID-19 vaccines…

We talked about Moderna last month. Moderna is applying synthetic biology to develop a COVID-19 vaccine. And it made the news back in March when it took its synthetic vaccine into Phase 1 clinical trials.

As a reminder, Moderna’s approach uses messenger RNA (mRNA) to produce an immune response in patients. Here’s how it works…

Genetic code determines an organism’s traits and bodily functions. It’s a “genetic blueprint.” But the genes themselves don’t do the work. They require proteins to carry out specific functions.

mRNA is the link between genes and proteins. The information contained within genes is transcribed into mRNA. That mRNA then tells the body what proteins to produce to carry out the genes’ functions.

Moderna’s vaccine mimics this process. It uses synthetic mRNA to tell the body to produce proteins that look like COVID-19. That helps the body to naturally produce antibodies to fight the virus and build immunity.

Moderna’s synthetic vaccine has moved quickly through both Phase 1 and Phase 2 testing. It is now moving into Phase 3, which is typically the final stage before a company can seek FDA approval for its drug.

For its Phase 3 trial, Moderna will administer the vaccine to 30,000 volunteers who have not yet contracted COVID-19. Moderna will then track each of these people for an entire year to make sure that they do not contract the virus or experience any adverse effects from the vaccine.

If the therapy is effective, Moderna said it could deliver 500 million doses per year by the end of this year. And it can deliver up to one billion doses of the vaccine next year.

Of course, the FDA will not approve the vaccine until Moderna has completed its one-year study of all 30,000 volunteers.

However, it’s highly likely the FDA will grant Moderna an EUA later this year if Phase 3 is successful. That would allow Moderna to make its vaccine available before receiving official FDA approval.

I am very excited to watch this one play out. Synthetic biology is one of the most exciting areas of biotech right now.

If Moderna’s synthetic vaccine is proven successful, it will be transformative for the entire industry. We’ll see more and more synthetic biology therapies developed as a result.

Second-generation CRISPR genetic editing companies are coming…

I was one of the first analysts to speak publicly about the investment potential of CRISPR genetic editing technology. I profiled CRISPR technology publicly in February 2016 in Exponential Tech Investor. Since then, best-in-class CRISPR companies went on to return as much as 376%.

And the developments in this space have only accelerated since then. I’m watching a “second generation” of early stage companies that are developing CRISPR technology get funded and progress toward future initial public offerings (IPOs).

Verve Therapeutics is an early stage company I have been tracking for a couple of years now. It just raised $63 million in its second venture capital (VC) round.

This comes on the back of a $58.5 million Series A round back in August 2018. So Verve has raised $121 million to date. That’s a lot of money for just the first two VC rounds.

And the reason Verve is attracting so much capital is that it is applying CRISPR genetic editing technology to heart disease by reducing bad cholesterol. This is a massive market.

Total sales for drugs that treat cardiovascular disease are expected to hit $70 billion by 2024. And the global market for cholesterol-lowering drugs is already nearly $20 billion. That’s what Verve Therapeutics is going after.

And the company’s approach is quite ambitious.

To date, CRISPR has been used to tackle genetic diseases caused by a single known genetic mutation. This is what I consider low-hanging fruit… easy to understand with a high probability of success. These diseases are a logical thing to focus on. Fix the one mutation, and you cure the disease.

Verve’s CRISPR therapy, however, seeks to introduce a helpful genetic mutation to people at risk of heart disease. Here’s how it works…

A small subset of the human population is naturally resistant to heart disease. That’s thanks to a genetic mutation that turns off the genes in the liver that raise cholesterol. As a result, these people naturally have low “bad” (LDL) cholesterol.

Verve’s approach is to apply that genetic mutation to at-risk patients with cardiovascular problems. If successful, this will lower their bad cholesterol naturally.

This would be a far better treatment compared to the statins and other cholesterol drugs on the market today, which cause unwanted side effects.

So Verve is seeking to disrupt the entire market for heart disease and cholesterol-lowering drugs. It’s a much broader approach than previous CRISPR therapies. That’s why Verve is getting so much attention right now.

And there’s some smart money backing this company. F-Prime Capital and ARCH Venture Partners have each invested in Verve’s first two VC rounds. These are two top-tier VC firms that often invest in early stage biotechnology companies.

And get this – GV has also been involved in both rounds. That’s right. Google’s VC arm is pouring money into Verve Therapeutics. I don’t care much for Google’s business practices, but I always take notice when it puts money into something.

Google has been taking a keen interest in companies that are involved in the health care space, especially those that have access to medical data that can be mined using artificial intelligence.

So this is another company we should add to our early stage watchlist. I expect it to go public within the next 12–18 months.

And like our first-generation CRISPR companies, Verve Therapeutics will make for a great investment target when the time is right.

Regards,

Jeff Brown
Editor, The Bleeding Edge

P.S. We’ll wait patiently for Verve Therapeutics to hold its IPO. But in the meantime, there’s another CRISPR company investors should pay attention to…

This company is on the verge of curing a form of blindness right now. And we aren’t talking about blindness in mice. We are talking about blindness in humans.

That’s right – this company is using CRISPR to take blind people and make them see again. How incredible is that?

And here’s the best part: The first patient has already been treated in an FDA-sanctioned clinical trial. We are weeks – maybe days – away from data from that trial coming out, revealing to the world that CRISPR has the power to make the blind see.

I expect this company’s stock price to soar hundreds of percent… maybe even 1,000%… after this news comes out. And that means this is a stock every tech investor needs to have in his or her portfolio. Simply go right here for all the details.

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