Novadiol is on a mission to improve the lives of people with chronic kidney disease (CKD). That’s a tall order for the six-year-old startup based in suburban Kansas City, Kansas.
CKD has emerged as a silent killer that is spreading as fast as diabetes across the U.S. Each year, it claims more lives than breast or prostate cancer.
“CKD is a large and growing problem,” says Tom Krol, Novadiol’s chief development officer. “Approximately 30 million people in the U.S. have CKD. The total market for CKD products to treat metabolic bone disease is an estimated $12 billion.”
Currently, Novadiol is in clinical trials with its first product ─ Dendocrin™ ─ which provides treatment for a condition called secondary hyperparathyroidism (SHPT) in stage 3 and 4 CKD patients, who are experiencing reduced kidney functioning.
“Our product stops the mobilization (release) of calcium from bones into the blood stream, which can increase the risk for skeletal fractures and cardiovascular disease,” Krol explains. “We have finished a phase one study, and we are negotiating with the FDA to do a single pivotal trial to get approval for the drug, which would be a major advantage.”
At the 2018 Michigan Growth Capital Symposium, Krol will be making a presentation to investors in an effort to raise a $20 million Series A round of financing. If he is successful, the funding will enable Novadiol to conduct its single pivotal trial for Dendocrin™ and start work on additional products for treating kidney disease.
Since its founding in 2012, Novadiol has raised a total of $3.2 million, which includes $1 million of founders’ money, $1 million in seed funding and a $1.2 million bridge financing round.
“At the MGCS, we will be looking for a lead investor and other interested investors who want to join our syndicate for our Series A round,” Krol says. Currently, 12 to 14 investors, including venture capitalists, high-net-worth family groups and investment bankers, already have expressed interest in the syndicate deal.
Krol anticipates Dendocrin™ could be out on the market in as little as three to four years. “We are able to do our drug development faster, cheaper and easier,” he explains, “because we are repurposing an existing drug developed and sold by the Upjohn Company for another indication in the 1980s and 1990s. We are able to file a 505(b)(2) new drug application (NDA) since we are using safety data that Upjohn generated.”
Once FDA regulatory approval has been secured, Krol projects Dendocrin™ could generate an estimated $250 million in revenue during a peak sales year.
As a Chicago native with a pharmaceutical degree from Ferris State University and family members in the Detroit area, Krol is realistic about the challenges confronting a biopharma startup that is trying to raise venture capital in the Midwest.
“Michigan and the Midwest are still considered ‘fly over’ country, and most people will go to the East and West coasts to get big dollars,” he concedes. “But we’re starting to see some changes. We’re going to get this company funded, and it would be great if we could do that in the Midwest.”