Small Business Innovation Research Program Provides Seed Funding for R&D

[Knoxville, TN], April 26, 2021 – NellOne Therapeutics, Inc. (NellOne) has been awarded a National Science Foundation (NSF) Small Business Innovation Research (SBIR) Phase I grant for $250,000 to conduct research and development (R&D) work on evaluating the therapeutic potential of NV1, a proprietary variant of the naturally occurring NELL1 protein with enhanced properties for commercial manufacturing and healing injuries in soft tissues.

“NSF is proud to support the technology of the future by thinking beyond incremental developments and funding the most creative, impactful ideas across all markets and areas of science and engineering,” said Andrea Belz, Division Director of the Division of Industrial Innovation and Partnerships at NSF. “With the support of our research funds, any deep technology startup or small business can guide basic science into meaningful solutions that address tremendous needs.”

NellOne is developing NV1 as a first-in-class biopharmaceutical to restore damaged lung tissues such as those caused by severe viral infections (e.g. COVID19 and flu).  The fatalities in these conditions are mostly due to Acute Respiratory Distress Syndrome (ARDS) which endangers 3 million patients annually in the U.S. and has a high mortality rate (46%). Despite extensive research for the past 20 years, the incidence of ARDS continues to rise and presents challenging clinical conditions to effectively manage and treat. A pilot study in SARS-CoV-2 infected mice recently showed that NV1, increases survival by regulating and balancing the hyperinflammation and excessive response of the immune system. If successfully translated into humans, NV1 can potentially reduce ARDS-associated morbidity and prevent long/term disability in survivors. NellOne’s SBIR grant is designed to validate the effects of NV1 in cultured human lung tissues and in a larger population of a mouse COVID19 model to examine further the molecular and cellular effects on lung tissues and potential gender-based differences in response to NV1 treatment.

“During this pandemic, we have witnessed that when sound science and technology are developed in partnership with the US federal government and other private organizations, life-saving diagnostic tests, vaccines and therapeutics are created and delivered to save millions of lives,” said Dr. Cymbeline Culiat, President and Chief Science Officer at NellOne. “NellOne Therapeutics, is greatly honored and excited to receive this initial significant financial support from the US government through NSF. Being selected for this grant after a rigorous highly competitive peer review is an expression of NSF’s favorable assessment of the innovation and potential great impact of NVI technology in addressing a medical problem that has eluded effective solutions for decades.  This research funding allows NellOne to move one step closer to improving patient outcomes by treating the severe lung tissue damage in ARDS patients.”

Once a small business is awarded a Phase I SBIR/STTR grant (up to $256,000), it becomes eligible to apply for a Phase II (up to $1,000,000). Small businesses with Phase II funding are eligible to receive up to $500,000 in additional matching funds with qualifying third-party investment or sales.

Startups or entrepreneurs who submit a three-page Project Pitch will typically know within one month if they meet the program’s objectives to support innovative technologies that show promise of commercial and/or societal impact and involve a level of technical risk. Small businesses with innovative science and technology solutions, and commercial potential are encouraged to apply. All proposals submitted to the NSF SBIR/STTR program, also known as America’s Seed Fund powered by NSF, undergo a rigorous merit-based review process. To learn more about America’s Seed Fund powered by NSF, visit: https://seedfund.nsf.gov/

About NellOne Therapeutics, Inc.: NellOne is pioneering advances in regenerative medicine to restore injured tissue to its normal functional state. NellOne is dedicated to harnessing the power of the NELL1 / NV1 protein to improve outcomes for patients around the world, who suffer from significant soft tissue damage incurred in traumatic injuries or diseases. The NELL1 signaling protein’s healing properties are derived from its activity during early mammalian development in the production of an environment (extracellular matrix) that promotes pathways to regulate inflammation, increase cell/tissue survival under adverse conditions, recruit stem cells, and enhance blood vessel formation — thereby supporting new tissue formation and maturation to replace damaged tissues. For more information on NellOne visit nell-one.com.

About the National Science Foundation’s Small Business Programs: America’s Seed Fund powered by NSF awards $200 million annually to startups and small businesses, transforming scientific discovery into products and services with commercial and societal impact. Startups working across almost all areas of science and technology can receive up to $2 million to support research and development (R&D), helping de-risk technology for commercial success. America’s Seed Fund is congressionally mandated through the Small Business Innovation Research (SBIR) program. The NSF is an independent federal agency with a budget of about $8.5 billion that supports fundamental research and education across all fields of science and engineering.