New SEC rules will help small biotechs deliver the medicines we need

April 28, 2020
ICYMI: New SEC rules that went into effect yesterday will help small biotechs research the medicines we need for COVID-19 and many other diseases. There's also more news on one BIO member doing incredible research with animal biotech to help humans fight this pandemic…
BIO

ICYMI: New SEC rules that went into effect yesterday will help small biotechs research the medicines we need for COVID-19 and many other diseases. There's also more news on one BIO member doing incredible research with animal biotech to help humans fight this pandemic. Here are around 800 words, 4 minutes.

New SEC rules will help small biotechs deliver the medicines we need

Amidst the countless coronavirus headlines, you might have missed this news: changes to SEC rules just went into effect that will offer welcome relief for small biotech companies and help them deliver the new medicines we need. Here’s the scoop.

Catch me up! The Securities and Exchange Commission (SEC) adopted regulatory changes providing small public companies with a temporary exemption from compliance with Sarbanes-Oxley Act of 2002 Section 404(b), which requires public companies to report on internal controls they have in place over financial reporting.

Section 404(b) is well intended—but it’s been proven to reduce company market values, increase audit fees, force companies to exit public markets, and reduce R&D investments in pre-revenue startups, and thus, lead to less innovation. 

But without an exemption, it’s estimated it would cost small companies more than $800,000 to comply, forcing small biopharmas that do not generate revenue to choose between spending their limited funds on critical research or on filing paperwork with the SEC.

Now, thankfully, some small, public companies are exempt—specifically, companies with public float of less than $700 million and annual revenues less than $100 million.

The amendment to the rule went into effect yesterday, April 27. BIO has long advocated for the change (examples here and here).

Why it matters, especially now: Many small biopharmas with little to no revenue (yet) are working on the frontlines of the coronavirus pandemic. They need every dollar they can get to fund important R&D on vaccines, treatments, and cures for COVID-19 and other deadly diseases. This change provides these companies with temporary relief from a burdensome and expensive regulatory obligation with few economic or societal benefits—allowing them to focus on the science that will lead the world out of the crisis.

Background:


More Health Care News:

Bloomberg: Vaccine could potentially be available later this year, coalition says
The Coalition for Epidemic Preparedness Innovations (CEPI) believes a vaccine could be available as early as this year, much faster than initially thought, for vulnerable groups like health care workers. 

Boston Globe (Opinion): Restrictions on coronavirus patents would restrict research
“During the COVID-19 pandemic, when rapid investment is needed most, lawmakers should reaffirm their support for research-based innovation.” 



 
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“The little biotech company that could beat COVID-19”

Today we’re catching up on the news about SAB Biotherapeutics, the BIO member company using genetically engineered cows to produce human reagent antibodies to help diagnose and treat the coronavirus. Here’s the latest. 

“The little biotech company that could beat COVID-19.” That’s what Sioux Falls Business journalist Jodi Schwan calls the company in her latest column.

She breaks down what the company’s doing—and why it’s so important. Their unique approach specifically targets COVID-19, they’re rapidly developing it, they’re getting up to $16.6 million in BARDA funding to get it off the ground, AND they have a track record with similar diseases. 

Their science is a potential game changer. “One of the advantages of SAB’s approach over collecting antibodies from convalescent plasma is that blood can be repeatedly collected from the same immunized cows for at least four years, eliminating donor-to-donor variations in antibody responses,” BioCentury explains in another recent article. “Using antibodies from the same cows also reduces the likelihood of antibody aggregation, which [SAB CEO Eddie] Sullivan said can arise when pooling convalescent plasma from different donors.”

This is what we mean when we talk about One Health. SAB has explored the links between animal health and human health to find what could be a groundbreaking discovery in the race to defeat COVID-19, and potentially other diseases. 

It’s also an example of why it’s important to support the small biotechs, too. These “little biotechs that could” have been on the frontlines of this battle and researching the science that could save millions upon millions of lives. We must ensure that policy supports them and helps them survive and thrive in this crisis.

 

More Agriculture & Environment News: 

POLITICO: Trump cuts U.S. research on bat-human virus transmission over China ties
“The National Institutes of Health on Friday told EcoHealth Alliance, the study’s sponsor for the past five years, that all future funding was cut. The agency also demanded that the New York-based research nonprofit stop spending the $369,819 remaining from its 2020 grant.”

 
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President Trump’s Tuesday: Meeting with the Governor of Florida, then giving remarks about the Paycheck Protection Program. There’s no Coronavirus Task Force press briefing on the schedule today, but who knows?

What’s Happening on Capitol Hill: The House and Senate are officially planning to return to Washington on May 4, though some House Democrats think it’s still too dangerous, reports POLITICO.

 
 
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