Richmond startup Qnovia has completed a second part of a Series A funding round and hopes to begin clinical trials of its smoking cessation technology soon.
The company announced a $17 million equity round in August and it recently raised an additional $2.9 million, according to Securities and Exchange Commission filings. CEO Brian Quigley said the round has been completed and is larger than indicated in public documents. He did not divulge the exact figure, because he said the securities filings have not been finalized.
Richmond's Blue Edge Capital and New York City's Evolution Venture Partners led the additional $2.9 million in equity funding. Both were already investors in the company.
Quigley said the company decided to raise additional capital to give itself better long-term stability. The company had enough funding for initial clinical trials but felt, given the current fundraising environment, that it needed more cash on hand.
“It's a higher interest rate environment, [and] the markets have been a little bit challenging in the first half of the year,” he said.
Health care executive Mario Danek founded Qnovia in 2018. The goal is to develop and market RespiRx, a hand-held aerosol medical device that delivers nicotine quickly, helping people quit smoking. In 2020, Quigley, the former CEO of Altria Group’s smokeless division, joined the company as chief operating officer. He was named CEO in August, and Danek moved to chief technology officer.
The company plans to apply to the Food and Drug Administration in next few months and begin clinical trials. Qnovia must show evidence that a prescription-based product can help people quit smoking. Quigley said nicotine gum and patches are available over the counter and are approved smoking cessation products, but Qnovia believes a doctor should be involved when a person wants to quit smoking.
The device has a limited number of doses. Over a 12-week period, it reduces the amount of nicotine inhaled and thus hopefully reduces the person’s dependency on nicotine. Quigley said e-cigarettes are designed as an alternative to smoking but not approved as a therapy to help a person quit smoking.
“The real shortcoming of the existing nicotine replacement therapies, like patches and gums, is that they don't deliver enough nicotine into the body fast enough to alleviate withdrawal symptoms,” Quigley said.
The company has six employees, and Quigley said he is focused on keeping the company lean. A lot of the research and testing is done through contract labs. A recent key addition is former FDA Director Mitch Zeller, who joined the company as an adviser in April. Zeller has 40 years of experience at the FDA and is advising the company on regulatory issues.
“He brings a lot of perspective and guidance for us, and he fundamentally, as I do, believes that an inhaled prescription smoking cessation therapy could really be a game-changer in really helping to end the death of disease caused by smoking,” Quigley said.
The goal is to have U.S. clinical trials completed by 2025 and bring the product to market in 2026. Quigley said the federal government is looking to industry to help in smoking cessation efforts and has created alternative pathways to approval. That could mean the product becomes available sooner.
“I think there's opportunities and there's programs that FDA has — accelerated review and what's called breakthrough status, which is part of our engagement with FDA,” Quigley said. “I think we will try to capitalize on both of those programs.”
The company has also begun working with regulatory officials in the United Kingdom, Quigley said.
