Knoxville Serial Entrepreneur takes-on CEO role at NellOne Therapeutics

To say that Bill Malkes is excited about his latest executive leadership opportunity would be a gross understatement.

In a blogpost (Bill Malkes Blog Post) that ends with the words “let the revolution begin,” the Co-Founder and former Chief Executive Officer (CEO) of Knoxville’s GRIDSMART Technologies Inc. talks about a half-year journey to decide what his next endeavor would be and the key factors that led to his decision to become CEO of NellOne Therapeutics Inc. headquartered in Oak Ridge.

“For more than two decades, I’ve created and implemented successful strategic plans in high-risk situations,” Malkes wrote. “Each time, I’ve needed to make a difference, whether in home-based respiratory therapy, advanced microchip design, building a device to read DNA hybridization, creating a device making Blackberry and Palm Pilot devices smart, K-12 educational software, or pioneering vision processing based traffic control. Each ladder rung demanded meaning.”

After leaving GRIDSMART soon after its acquisition by Cubic Corporation on January 2, 2019, Malkes told anyone who asked that he wanted to spend time carefully evaluating his next move and would consider opportunities to consult with companies to gain better insights. NellOne Therapeutics, an early stage biopharmaceutical company focused on regenerative medicine, was one of those engagements.

“I took my time,” Malkes says. “I so believe in the mission of Nell One Therapeutics. It’s smart, ethical and efficient healing . . . regenerating what in the body that needs to be fixed. Regeneration is healing.”

As CEO, he’s assumed the role formerly held by Tracy Warren, one of the company’s two Co-Founders who becomes Chair of the Board of Directors. The other Co-Founder – Cymbeline (Bem) Culiat continues as President and Chief Scientific Officer.

For the straight-talking and always candid Malkes, his fifth tech-based leadership opportunity since moving to East Tennessee in 1999 (see our 2012 article chronicling his journey) is one that draws on his deep-seated sense of doing something that is truly meaningful and impactful on society and being part of a team that shares those very important values.

“Tracy and Bem were 15 years ahead of their time,” Malkes told us in describing their vision for how to use NELL-1, a naturally occurring secreted human protein that triggers multiple processes for tissue growth and maturation during development and after injuries. With dozens of patents in eight countries, NellOne Therapeutics is developing therapies with partners across multiple modalities leveraging the healing potential of NELL-1.

It helped that Malkes had met Culiat and Warren years ago and reconnected with them after leaving GRIDSMART. “The vision and heart of NellOne stood out to me from the moment I was introduced to the business, and it’s no exaggeration to say that it was awe-inspiring,” he said.

In addition, Culiat had recently achieved major scientific breakthroughs in the production of protein that is highly more efficient with greater yields. That fact has positioned the company to really accelerate its commercialization plans at a particularly challenging time for this country and others.

“Our vision is to be a protein production company and create partnerships in particular modalities,” Malkes explains, adding, “Our focus is making the protein.”

Why is protein production so important? He points-out the impact that COVID-19 is having on the respiratory system of many victims as one example.

“It regulates the cytokine storm,” Malkes says about some coronavirus patients who exhibit the excessive immune system response also known as the cytokine storm. “It (the Nell-1 protein) doesn’t block the inflammatory responses, it regulates them. When it’s done fixing something, it goes away.”

Nell One Therapeutics will be raising an angel round to “move the ball down the field before a Series A round,” Malkes says. The company will also be exploring grants as Malkes and Culiat focus on the revolution ahead.

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