A small pharmaceutical company in Chapel Hill has landed a $15 million raise to advance multiple clinical programs focused on pulmonary diseases.
The funding will support Renovion as it moves forward three different programs, including a phase 3 study that recently began enrolling patients as well as two phase 2 studies — one of which began in 2022 and another that will kick off his year. The raise gives the company a 24-month runway to see it through the studies.
The raise was driven by individuals and family office-type investors, CEO Dan Copeland said. When Renovion began looking to raise money, the company reached out to regional and national venture capital firms, but found they were more focused on their current portfolio, given the challenging financial market.
Instead, Renovion pulled together a round that includes new investors and those who participated in the company's $8 million Series A in 2020. A total of 24 investors participated in the equity round, according to a filing with the U.S. Securities and Exchange Commission.
"It's investors who knew us well ... and also people in biotech who appreciate how far we have come," Copeland said.
The funding will support all of the company's clinical work, Copeland said. Renovion is developing a nebulized therapy, called Arina-1 — which the company originally licensed from UNC-Chapel Hill — that's delivered to a patient's lungs to treat pulmonary diseases.
The company's most advanced program is in a phase 3 study focused on preventing a rare condition called bronchiolitis obliterans syndrome in adults who have received a bilateral lung transplant. This is a potentially fatal disease for which there is currently no federally approved treatment.
A few days after filing SEC paperwork for the raise, Renovion announced it has received fast track designation from the U.S. Food and Drug Administration for the phase 3 program – meant to accelerate the development and review of drugs that aim to treat serious conditions and fill unmet medical needs. The designation allows Renovion to file parts of a new drug application to the FDA through a rolling submission process.
Renovion is enrolling patients in this study at lung transplant centers throughout the U.S. Copeland said the company aims to have the study fully recruited by late this year, and have data by early 2024. If the trial is successful, the fast track designation could expedite the company's filing of a new drug application to seek FDA approval.
"Ideally (the designation) shortens the regulatory timeline," Copeland said. "As we go through, we can submit parts of the NDA and they can be reviewed before we have the whole package put together."
As a small company of six to eight people — which could grow to 10 this year — Renovion will remain flexible in its approach toward commercialization. If the FDA approves the treatment, Renovion could look to sell the asset to a larger pharma company. However, given the concentration of lung transplant patients at select centers throughout the U.S., Renovion could also build out its own commercial arm with a relatively small sales workforce, Copeland said.
Renovion is also advancing its nebulized therapy as a treatment for non-cystic fibrosis bronchiectasis in a phase 2 study that began enrolling patients in 2022. Later this year, Renovion will launch a phase 2 study evaluating the treatment for nontuberculous mycobacteria lung disease.
If these studies result in positive data, Renovion could look for a strategic partner that would take the programs through phase 3 studies and into commercialization. If it doesn't follow this route, Renovion would need to raise money through another round of private capital or a public offering to move these programs forward without a partner. Copeland said the company would let the data lead it to the right path.
