Tag: Qnovia

Qnovia Raises $16 Million

Qnovia has raised $16 million in Series B funding. The financing was led by Blue Ledge Capital, Evolution VC Partners, Vice Ventures and Gaingels.
“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,” said Brian Quigley, CEO of Qnovia.
“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 nonclinical 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 U.K. 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.”
Since its inception, Qnovia has raised $50 million to advance its proprietary inhaled drug delivery platform. Qnovia will use the proceeds from the recent financing to support the clinical, regulatory and commercial development of its RespiRx Nicotine Inhaler (QN-01) in the U.K. QN-01 has demonstrated clinical proof-of-concept in a first-in-human, Phase 1 study and received U.S. Food and Drug Administration clearance of its Investigational New Drug application. In addition, the company will use the Series B funds to evaluate the feasibility of additional therapeutic indications in their pipeline.
“We are impressed by Qnovia’s agility and speed in navigating the complex regulatory framework for the development of novel smoking cessation therapies,” said Andy Roche, founder and managing partner at Blue Ledge Capital. “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.”
December 12, 2024
FDA clears RespiRx IND

Image: Qnovia
The U.S. Food and Drug Administration has cleared an Investigational New Drug (IND) application for Qnovia’s RespiRx nicotine inhaler (QN-01).
According to Qnovia, the RespiRx is the first truly inhalable nicotine replacement therapy (NRT) to assist smokers attempting to quit smoking.
The company will initiate a Phase 1, randomized, crossover, open-label trial to determine the pharmacokinetics, safety and tolerability following self-administration of nicotine-containing products in up to 24 healthy adult subjects who currently smoke combustible cigarettes.
“The FDA clearance of our IND application for QN-01 marks a significant achievement for Qnovia as we transition to a clinical-stage therapeutics company,” said Qnovia CEO Brian Quigley in a statement.
“Our U.S. clinical development plan is derisked by the positive first-in-human data we generated last year in support of advancing QN-01 in the United Kingdom where we demonstrated pulmonary delivery and a superior pharmacokinetic profile for the RespiRx when compared to existing nicotine replacement therapies,”
“The next step for our U.S. program is to initiate a randomized Phase 1 trial that evaluates QN-01 compared to the Nicotrol Inhaler and combustible cigarettes in a head-to-head comparison. We remain on track to dose our first patient in the fourth quarter of 2024 and in parallel will be advancing to a pivotal clinical trial in the U.K. to support an MAA submission [Marketing Authorization Application] to the MHRA [ Medicines and Healthcare products Regulatory Agency] in 2026.”
Qnovia’s proprietary drug/device combination already demonstrated dose-dependent pharmacokinetics, pulmonary delivery and was well tolerated in a first-in-human study conducted to support advancing QN-01 in the U.K., according to the company.
“There have been no treatment options for smoking cessation approved in the U.S. in over 20 years. As a result, attempting to quit ‘cold turkey’ remains the most popular method of quitting smoking,” said Mitch Zeller, Qnovia’s policy and regulatory strategy advisor.
“There is an extraordinary public health need for truly innovative products to help health-concerned smokers stop using cigarettes. Any effort to reduce the death and disease caused by tobacco use must include new and better tools in the treatment toolkit,” Zeller added.
October 1, 2024
‘Medical Vapes Facing Uphill Battle’

Photo: DALU11
Companies developing vape-like devices to ease medical conditions such as migraines and respiratory diseases continue to face skepticism from health authorities and the public, according to a Reuters article.
The piece details the efforts of Qnovia, MIIST Therapeutics and Greentank, which are exploring the potential of nebulizer technology or heating technology to deliver medications.
The companies say inhalation can relieve pain faster and with fewer side effects than pills. Federico Buonocore, a professor focused on alternative pulmonary drug delivery at Kingston University in Britain, told Reuters that existing inhaled drug delivery devices are clunky and difficult to operate, and so tend to be used wrongly. A vape-like design could solve such challenges, he was quoted as saying.
Qnovia plans to submit drug applications in the U.S. soon and the United Kingdom in 2026 for its device as a nicotine replacement therapy, and launch a clinical trial in September.
Greentank is looking for a pharmaceutical partner to support the development of its heating chip for medicine delivery.
Efforts by traditional tobacco companies to tap into the pharmaceutical market have been hampered by mistrust and opposition from health officials.
Philip Morris International last year scrapped a goal to earn over $1 billion in annual revenue by 2025 from its wellness and healthcare unit, which includes a business making asthma inhalers.
CEO Jacek Olczak said the company had been “too optimistic about how the external environment will accept… Big Tobacco” in industries outside of nicotine. An inhaled aspirin product developed by the unit was also deemed unsuccessful after a clinical trial last year.
Tobacco-backed companies developing Covid-19 vaccines using plant-based technology also faced stiff opposition from health groups, including the World Health Organization.
Buonocore said the stigma associated with tobacco and vaping companies would be difficult for the sector to overcome.
August 9, 2024
Qnovia Expands Scientific Board

Photo: Mariakray
Qnovia has appointed four new members to its scientific advisory board (SAB). The new members are Neal Benowitz, professor at the University of California at San Francisco, Ian M. Fearon, independent consultant, Darla E. Kendzor, professor at University of Oklahoma Health Sciences Center, and Nicole Nollen, professor at University of Kansas.
“Our newly appointed advisors bring world-class scientific and multi-disciplinary expertise and reaffirm our commitment to advance novel therapies for the millions of people who seek to quit smoking,” said Qnovia CEO Brian Quigley in a statement.
“We are grateful for the leadership of the chair and founding member of our SAB, Dr. Jasjit S. Ahluwalia, a professor at Brown University, who has been instrumental in shaping the direction of our SAB over the past year. The expansion of our SAB complements the regulatory expertise of our policy and regulatory strategy advisor, Mitch Zeller, who served a prior appointment as director of FDA’s Center for Tobacco Products.”
Qnovia is a pharmaceutical company developing inhaled therapeutics across a variety of indication areas leveraging its proprietary inhaled drug delivery platform, the RespiRx.
“Looking ahead, our SAB will serve a critical role as we advance the clinical development of our lead asset, QN-01, towards FDA and MHRA approval,” Quigley said. “We believe our proprietary drug-device combination platform has the potential to be a first-in-class and best-in-class treatment for smoking cessation.
“Last fall, QN-01 demonstrated a superior pharmacokinetic profile compared to existing nicotine replacement therapies in our first-in-human Phase 1 clinical trial. We plan to submit our IND and CTA to the regulatory bodies and look forward to commencing our Phase 1/2 clinical study this year. Overall, we are highly encouraged by the data we have generated to date and believe that 2024 is going to be a pivotal year for Qnovia,” he added.
April 9, 2024
Cessation Therapy Validated in Study

Image: Qnovia
Qnovia announced positive results from its first in-human study of QN-01, an inhaled smoking cessation therapy that is currently being evaluated by the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) and the U.K.’s Medicines and Healthcare Products Regulatory Agency (MHRA).
“Today marks a pivotal milestone for Qnovia as we believe this data validates the clinical translation of our platform for the first time in patients,” said Qnovia CEO Brian Quigley.
“One of the reasons that quitting smoking is so challenging is that cigarettes provide a significant nicotine spike directly into the bloodstream within seconds. The challenge with current nicotine replacement therapies is that they fail to deliver nicotine quickly enough and at concentrations high enough to effectively alleviate a smoker’s withdrawal symptoms. Unfortunately, this leads to smokers relapsing, resulting in a significant unmet need for novel smoking cessation therapies.

We believe our nicotine delivery platform has the potential to solve this complex pharmacokinetic puzzle and could be a game changer in alleviating cravings and withdrawal symptoms for those smokers who need it most
Brian Quigley, CEO, Qnovia
“We believe our nicotine delivery platform has the potential to solve this complex pharmacokinetic puzzle and could be a game changer in alleviating cravings and withdrawal symptoms for those smokers who need it most,” said Quigley.
“We are delighted to share that QN-01 demonstrated a superior pharmacokinetic profile compared to an existing inhaled NRT and was well tolerated. We look forward to submitting our IND and CTA for QN-01 and advancing our clinical development program into Phase 1/2 clinical trials next year.”
The Phase 1 study was an open-label trial evaluating the delivery of QN-01 for three different nicotine dosing regimens to determine the pharmacokinetics and safety profile of Qnovia’s drug delivery platform in 12 healthy adults who currently smoke combustible cigarettes. Each adult received three different doses of treatment delivered on subsequent days after a washout period.
The study confirmed dose-dependent pharmacokinetics of QN-01 delivered with the Qnovia’s RespiRx device. The mean maximum plasma concentration (Cmax) was higher, and the time to achieve the maximum plasma concentration (Tmax) was lower for QN-01 across all three dose regimens, demonstrating superior pharmacokinetics compared to an existing inhaled nicotine replacement therapy (NRT). The drug-device combination was well tolerated with no severe adverse events and few minor adverse events typical of inhaled nicotine.

Highlights of Initial Phase 1 Pharmacokinetic and Safety Data
“We are pleased to see our platform being utilized for the first time in human clinical trials. We believe these results validate that we have identified an optimal Cmax for QN-01 that is higher than the currently available inhaled NRTs but lower than combustible cigarettes, thus enabling QN-01 to have optimal therapeutic efficacy while mitigating abuse liability potential,” said Mario Danek, Founder and chief technology officer of Qnovia.
“What makes our platform unique is that the RespiRx device utilizes a vibrating mesh nebulizer aerosol engine with zero heat to create an aerosol that can be inhaled by the smoker. Given our e-liquid drug product is not heated, there is no formation of thermal degradants or other toxicants during the aerosol generation process. As a result, our device platform is uniquely positioned to meet CDER’s safety standards. Looking ahead, we are committed to advancing QN-01 into the next stage of clinical development and will be working closely with FDA and MHRA to bring this treatment option to the millions of smokers who want to quit.”
November 29, 2023
High-Tech Quitting

Photos: Qnovia
Qnovia wants to increase smoking cessation rates with a disruptive inhaler technology.
By Stefanie Rossel
For smokers eager to quit, there’s a plethora of nicotine-replacement therapy (NRT) products on the market. However, whether they come in the form of lozenges, patches, gums, nasal sprays or prescription inhalers, the effectiveness of these cessation aids is disappointingly low. A study conducted by the Swiss Institute of Social and Preventive Medicine in 2006 found that the chance of a smoker quitting cigarettes long-term with the help of NRTs was a mere 7 percent. There’s no sign that this rate has improved in recent years. The poor performance is due in part to the fact that NRTs fail to provide instant relief of the physical sensations that contribute to cravings.
Qnovia, a Richmond, Virginia, USA-based medical technology and pharmaceutical company established in 2018, has set out to address this shortcoming with a new drug delivery technology. The firm has developed RespiRx, a handheld, pocket-size device capable of producing a medically safe aerosol without heat. The device consists of a vibrating mesh nebulizer, which is a combination of a vibrating piezoelectric actuator and a piece of mesh that diffuses a drop of liquid into a fine mist on contact.
Piezoelectric materials can produce electric energy upon application of mechanical stress. A commonly known piezoelectric is quartz. The technology, which usually involves clunky equipment and requires regular cleaning, has been used for many years for applications unrelated to smoking cessation.
Qnovia has made it more user-friendly, according to Qnovia CEO Brian Quigley, who spent 16 years with Altria Group, including seven as president and chief executive of the company’s smokeless and innovative products/vapor businesses.
“Vibrating mesh nebulization is a proven and safe method for delivering inhaled therapies; however, our proprietary device is designed to be orientation-agnostic and requires no cleaning or maintenance,“ he says. “Not only are there proprietary elements to achieve this, but the entire nebulizing engine is also miniaturized and part of the drug product containing carriage that continuously feeds the drug to the mesh, maintaining a controlled flow rate and thereby delivering a precise dose when activated with the user’s breath.”
The device works with a 12-week step-down dosage regimen consistent with other Qnovia NRTs. Every three seconds of inhalation registers as an individual dose, with a running count displayed on a panel of the battery unit. Working with a general practitioner or tobacco treatment specialist, patients are given a tapering dosage schedule according to their own consumption level. The concentration of pharmaceutical-grade nicotine in the cartridges remains constant over the duration of the program, with the device limiting the dispensation of doses in a single day and adjusting the limit per the regimen.
RespiRx has a higher pharmacokinetic curve than existing NRTs but a lower one than combustible cigarettes so that patients require progressively fewer doses as cravings subside. According to Quigley, one of the largest problems with existing buccal and transdermal solutions is that they don’t deliver the nicotine to the bloodstream quickly enough to alleviate withdrawal symptoms.

Vibrating mesh nebulization is a proven and safe method for delivering inhaled therapies; however, our proprietary device is designed to be orientation-agnostic and requires no cleaning or maintenance.
Brian Quigley, CEO, Qnovia
Unique Features
While RespiRx, with its high-tech design and elaborate features, may resemble an electronic cigarette, it is in fact a very different product, according to Quigley. “At its core, our device is a medical technology designed to achieve the FDA’s [U.S. Food and Drug Administration] Center for Drug Evaluation and Research’s [CDER] standards for safety,” he says. “So our device has multiple design features that make it wholly different than an e-cigarette. First, we use no heat to create the aerosol, which ensures there is no risk of exposing the user to thermal byproducts or degradants. Second, our drug product is also designed only using excipients that are safe for inhalation in a drug context, and third, the design of the device is meant to achieve CDER safety standards for airpath and safety, which are not requirements achieved by e-cigarettes.”
RespiRx’s technology also differs from Kind Consumer’s Voke, a breath-activated device that worked like an asthma inhaler. The product was designed to deliver rapid nicotine craving relief without heat, combustion or vapor. It looked like a cigarette, and its consumption ritual mimicked smoking.
The U.K. Medicine and Healthcare products Regulatory Agency granted Voke a medical license in 2015, and Public Health England endorsed the product as a safer alternative to smoking. However, after raising £140 million ($171.42 million) and attracting investments from major companies, including BAT, the venture ended in late 2020.
According to Quigley, Voke delivered the user a cold shot of compressed polybutylene—in essence, a pressurized nicotine liquid, which appears to have impacted the user experience.
By contrast, Qnovia’s device delivers a laminar, nonturbulent aerosol. “Not only does our aerosol appear to look vapor-like, but it’s also designed to be inhaled easily under normal inspiratory conditions, unlike the Voke,” says Quigley.
Quigley is confident that RespiRx won’t suffer the same fate as Voke. “Firstly, the RespiRx’s on-device LCD screen prompts and future mobile app connectivity will play important roles in advancing patient adherence and compliance rates,” he says. “These tech-enabled features simply didn’t exist with Voke’s low-tech, data-absent approach. Secondly, from a broader drug-delivery platform perspective, the RespiRx is actually able to deliver complex, pressure-sensitive molecules like biologics. Voke was tied to one indication area, where the underlying technology for broader API adoption would have been a challenge. The RespiRx, on the other hand, is already engaging in activities to expand Qnovia’s active pharmaceutical ingredient portfolio beyond nicotine.”
According to the company, the RespiRx technology could be used to deliver a variety of drugs for various future indications, including asthma, chronic obstructive pulmonary disease or chronic pain.

Into the Clinical Trial Phase
In the NRT category, RespiRx will compete with FDA-approved nicotine inhalers such as Nicorette, which is available without a prescription. Quigley believes RespiRx will prove to be a more effective solution.
“The Nicorette inhaler delivers large droplets containing nicotine into the patient’s mouth,” he says. “This results in buccal absorption, so it’s not an inhaled delivery mechanism despite its name, which limits the ability of the drug to rapidly and effectively alleviate withdrawal symptoms, where our device delivers an aerosol with particle dynamics that deliver the drug to the lung, which will result in more immediate drug delivery and improved ability to alleviate withdrawals. Also, the inhaler has a very harsh and bitter taste, which limits adoption, whereas our formulation does not have these unpleasant effects.”
Making smoking cessation medication—or novel nicotine-delivery products for that matter—permanently acceptable for smokers continues to be a challenge. Quigley says RespiRx’s formulation has no flavor. Since the product’s target audience is looking to ultimately stop consuming tobacco products altogether, they want an experience that is different from that offered by existing alternatives and one that helps them move away from smoking over the 12-week user regimen.
In October 2022, Qnovia raised $17 million to help RespiRx through the FDA’s Investigational New Drug Application process. “Once we submit our IND, we will execute phase I, II and III studies with FDA guidance; however, the study design, powering and endpoints are all already very clearly defined,” says Quigley.
The company plans to submit its final new drug application to the FDA in 2025. Approval is likely to come faster than for new tobacco products going through the FDA’s premarket tobacco product application process. “At the appropriate time, we expect to also request breakthrough and accelerated review status, which are established programs to facilitate the submission, review and final decisions for drugs,” says Quigley. “Largely, I believe CDER does a very good job hitting its timing performance requirements, and the burden of proof we have to demonstrate is clear and well defined. For all these reasons, I believe we have a significant advantage engaging with CDER despite the cost and time we invest in generating strong data for the agency.”
Instead of marketing RespiRx as an over-the-counter product, Qnovia has chosen to pursue prescription-only status. “We believe that it is important to ensure that this therapy is only used as intended, and we want to be sure to not have abuse liability concerns. Given the design of the pharmacokinetic profile and the delivery of nicotine via inhalation, we strongly believe that a prescription path is important to ensure appropriate use under the care of a physician.”
Stefanie Rossel is Tobacco Reporter’s editorial contributor. An experienced trade journalist, she combines sharp reporting skills with in-depth knowledge of the tobacco and vapor industries. Prior to joining Tobacco Reporter, Stefanie was editor-in-chief at Tobacco Journal International, where she worked for a decade. Fluent in English, German and French, Stefanie covers tobacco news around the world. She is based in Germany.

March 1, 2023
Qnovia Raises $17 million for Nebulizer

Photo: Qnovia
Qnovia has raised $17 million to continue development of its RespiRx nicotine-replacement product, reports Richmond Business Sense.
RespiRx is a portable, hand-held nebulizer, a powered medical device that delivers medicine as an inhaled mist and is similar to an inhaler. The device is designed to deliver a nicotine hit more quickly than existing therapies, thus enabling users to better manage withdrawals and, therefore, increase the likelihood of smoking cessation.
Qnovia was founded in 2018 in Los Angeles by Mario Danek as Respira Technologies and rebranded in September. In May, the company appointed former Altria executive Brian Quigley as CEO and Danek as chief technology officer.
The company also moved to Richmond, Virginia, in part because that state offers a more business-friendly environment, according to Quigley, whose tobacco career included a six-year stint as CEO of Altria’s U.S. Smokeless Tobacco Co. subsidiary.
In addition, many of the partners the company works with are on the East Coast. Qnovia contracts with a Boston manufacturer to make its device and a firm in Pennsylvania to create the medicine administered through the device.
Qnovia will use the newly raised funds to develop a proof of concept for RespiRx as a nicotine-replacement therapy product and move it through an FDA approval process before the anticipated start of human clinical trials in 2023.
The product is expected to hit the market as a prescription treatment. Qnovia is also interested in exploring how RespiRx can be used for asthma, pain management, vaccines and other uses.
October 5, 2022