BIO-Led Summit to Build Collaboration Between Biopharma Industry, Government Leaders & Scientific Experts  Responding to the rapidly evolving COVID-19 public health crisis, the Biotechnology Innovation Organization (BIO) is taking the lead by hosting a virtual summit to help companies working on treatments, diagnostics and vaccines to come together to discuss challenges and opportunities with government officials and other stakeholders.  The two-day summit will take place on Tuesday, March 24 and Wednesday, March 25, and will be led by BIO President and CEO Jim Greenwood and Dr. George Scangos, President and CEO of Vir Biotechnology. BIO Board Chairman Dr. Jeremy Levin, CEO of Ovid Therapeutics, appointed Dr. Scangos to oversee the BIO Coronavirus Collaboration Initiative, which is intended to help connect innovators with partners across both the industry and inside the federal government to combat the coronavirus. The summit will include leaders from biotech and pharmaceutical companies, global academic experts in virology and immunology, and non-governmental organizations. Those invited to participate include Ambassador Deborah Birx, Dr. Robert Kadlec, and other senior leaders from key government offices, including the U.S. Department of Defense, U.S. Department of Health & Human Services, the Centers for Disease Control and Prevention, National Institutes of Health, and the Food and Drug Administration. Information regarding confirmed guests will be provided at a later date. As an international trade association representing more than 700 biotechnology companies, BIO is playing a unique role in organizing and coordinating the activities of many of its companies. More than 45 member companies are working to address coronavirus and more than 20 have products in various stages of development. “Close collaboration between America’s biopharmaceutical companies and the U.S. government is leading the global race to develop vaccines and…

The Securities and Exchange Commission (SEC) has adopted regulatory changes to provide small public companies with a temporary exemption from Sarbanes-Oxley 404(b) compliance. 404(b) requires public companies to report on the internal controls they have in place over their financial reporting. While well-intended, this regulatory requirement has proven to reduce market capitalizations, increase audit fees, force companies to exit public markets, and reduce R&D investments in pre-revenue startups that result in fewer inventions.  “Biotech companies across the country conduct their research without the certainty of a return on their investment, so they highly value resource efficiency,” said Jim Greenwood, BIO’s President and CEO. “Cost burdens like 404(b) can slow a company’s progress in the lab and lengthen the amount of time it takes to deliver treatments for patients in need. I applaud the SEC for adopting a commonsense approach to ensuring less capital is going into unnecessary compliance and instead into lifesaving science.”  Under the amendment, small public companies with public float of less than $700 million that have annual revenues of less than $100 million would be exempt from the 404(b) requirements. This regulatory obligation has been a longstanding burden for small biotechnology companies because of its extraordinary expense, their pre-revenue status, and the fact that it is of little use to their investors.  A similar proposal to the one adopted today was championed by Senators Kyrsten Sinema and Thom Tillis and Representatives Trey Hollingsworth and Ben McAdams. Together, they have sponsored the Fostering Innovation Act (S. 452, H.R. 3886), a bipartisan bill that would provide for a 5-year extension of 404(b) exemption for qualifying public companies included in the 2012 JOBS Act.  Background BIO, along with other industry voices, has long advocated for providing small biotech startups relief from costly 404(b)…