Pharmaceutical company Qnovia announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application for the RespiRx Nicotine Inhaler (QN-01), a prescription inhaled smoking cessation medicine. The company also announced that it raised $16 million in Series B funding, led by Blue Ledge Capital, Evolution VC Partners, Vice Ventures, and Gaingels.
Since its founding, Qnovia has raised $50 million to advance its proprietary inhaled drug delivery platform, RespiRx. The company will use the proceeds from the recent funding to support the clinical, regulatory, and commercial development of its lead asset, the RespiRx Nicotine Inhaler (QN-01), in the UK.
QN-01 has demonstrated clinical proof-of-concept in a first-in-human, Phase 1 study and received FDA clearance of its Investigational New Drug (IND) application. And the company will use the Series B funds to evaluate the feasibility of additional therapeutic indications in their pipeline.
KEY QUOTES:
“This Series B financing marks a meaningful milestone for Qnovia as it provides validation for our RespiRx™ proprietary platform, our progress in the regulatory process and the potential for our inhaled drug delivery platform to improve patient outcomes. We are grateful for the partnership with our investors who are committed to our vision of advancing the development of inhaled therapeutics for areas of high unmet need, starting with our focus on bringing innovation to medicines to support smoking cessation. Our recent infusion of capital will advance QN-01 beyond our Phase 1 clinical trial in the U.S. and support an MAA submission to the MHRA in 2026. We believe that the data we have generated for QN-01, which includes our positive first in-human clinical data and our non-clinical findings significantly derisks our clinical development plan and accelerates commercial validation to support our MAA submission for an expedited path to revenue generation in the UK. Overall, this financing brings us one step closer to our vision of transforming the treatment paradigm for smoking cessation for a population who has not had access to any new treatment options in several decades.”
- Brian Quigley, Chief Executive Officer of Qnovia
“We are impressed by Qnovia’s agility and speed in navigating the complex regulatory framework for the development of novel smoking cessation therapies. We are confident that their groundbreaking platform will revolutionize smoking cessation as well as drug delivery broadly as a result of its dose-to-dose consistency and favorable pharmacokinetic profile. We are honored to share that journey with the Qnovia team.”
- Andy Roche, Founder and Managing Partner at Blue Ledge Capital
