In an exclusive interview with The Fly, Respira Technologies CEO Brian Quigley discussed his new role, key differentiators, FDA plans, biotech challenges, opportunities and more.

CEO APPOINTMENT: Respira Technologies, a California venture-backed health tech company focused on commercializing proprietary inhalation device technologies to improve patient outcomes, announced in August the appointment of COO Brian Quigley as CEO of the company. Quigley, who previously served as president and CEO of Altria’s (MO) Smokeless and Innovative Products/Vapor Businesses, succeeded Respira founder Mario Danek, who moved into the role of CTO. “I joined the company in July of 2020 as COO and at the time our founder, Mario Danek, said there would be a point in our company’s journey where it would make sense for me to take over the leadership role,” the CEO said. “The move lets him continue to focus on the technology development side.” He added he was first attracted to joining Respira due to the massive opportunity created by the void in innovation for therapies for smokers trying to quit. “We’re now at a point where we are really focused on executing a very complex plan with a robust network of partners to execute our NDA to the FDA,” Quigley said. “My taking over as CEO is really an acknowledgement that the company is at its next phase, where Mario can continue to focus on tech development, IP and future device platforms and I can lead the organization, scale and successfully oversee the execution of a couple of complex plans.” He noted he is really excited to help consumers looking for help with smoking cessation, as there are over 20M smokers who will try to quit this year and most of them will fail. “There hasn’t been a meaningful innovation in the prescribed or over-the-counter cessation therapy space for over fifteen years,” the CEO said.

COMPETITIVE EDGE: When asked about the company’s key differentiators, Quigley pointed to founder Mario Danek’s core invention on the device technology. “His mission was to combine the human factors of a consumer product, so the portability, the ease of use, the user experience and the interface with the safety of that device technology,” he said, adding patients that use traditional vibrating mesh nebulizers suffer from poor compliance. “In a lot of those indications the meshes themselves need to be cleaned, and they are not maintained and cleaned, and all those nebulizers are gravity-fed,” the CEO said. “You pour the drug product liquid into a container, which leads the liquid over the mesh. If you tilt your head and the drug complex is not on the mesh, you’re not getting the medicine.” Respira’s device is orientation agnostic, miniaturized and portable, with prefilled cartridges containing the drug product that a user can operate at any direction. “Those are some of the things that make our device technologies differentiated,” he said. “I also think from a more macro perspective, we are focused on getting this authorization to be a prescription to help smoking cessation therapy. That is a space where there is not innovation going on as companies are really focused on other therapies. Our technology is purpose fit to serve this patient need.”

INHALATION THERAPIES: Respira is focused on creating breakthrough aerosol devices and formulations that deliver a broad range of pharmaceuticals as inhalation is a very effective way to deliver drugs to the body to treat illness, the CEO said. “Not every illness is designed to be treated this way, but today in the inhaled therapeutic market, there are over 90 drugs that are authorized by the FDA to be delivered and administered via that inhalation using a nebulizer-based technology,” he said. “Those drugs many of them, even if they are dominated by private label manufacturers, still represent billions of dollars of opportunity and market size.” Quigley noted inhalation is very effective in treating respiratory ailments like COPD, asthma and other indications and because of the efficacy, there is a lot of exploratory and new drug development work to identify new therapies for administration via inhalation. “Patients, practitioners and health personnel want efficacy, and they want compliance,” he said. “If you can have a product that delivers a drug effectively but also has very high levels of compliance, you can have the confidence that the patient is getting the medicine that they’re being prescribed. That’s why we chose to focus on this space and this massive opportunity to help millions of smokers to be more successful with quitting was a driving force in the early innovation and focus of the company.”

RESPIRX VMN DEVICE: Respira’s main product is the RespiRx, a “fit-in-your-pocket” and orientation agnostic vibrating mesh nebulizer with a digital metered dose interface and Bluetooth-enabled mobile app functionality. “In the nicotine replacement space, the therapies that are available to smokers that are trying to quit are oral like nicotine gums, transdermal like nicotine patches or pharmaceutical products like Wellbutrin,” Quigley said. “The reason they don’t work is when smokers try to quit and they’re dealing with those withdrawal symptoms, a cigarette delivers nicotine to the body very rapidly and at very high levels, so when a smoker starts chewing on a piece of nicotine gum, that gum by design delivers a slow release of nicotine into the body.” If a smoker is very stressed out, having cravings and really struggling, traditional smoking cessation products by design are not able to deal with the withdrawal symptoms, he said. “Our device is designed to create an aerosol with no heat and a particle size that is small enough below the three microns to actually deliver that nicotine down into the lung,” the CEO said. “The way that the device has been designed is to deliver that nicotine to our patients at the moment that they’re dealing with those cravings, at lower levels to the cigarette, but higher levels than a nicotine gum or a patch, to really more effectively alleviate those withdrawal symptoms.” RespiRx is designed to create an aerosol that delivers a very precise dose of nicotine and administer that in a use regiment that is very controlled, but also easy for the patient to understand, he said. “Those benefits can be levered across other therapies as well and we have the ability to optimize and change based on the drug and based on the use regimen,” Quigley said. “For asthma or COPD, that use regimen will be different than what is required for nicotine replacement therapy. We can optimize the aerosol dynamics and the amount of drug delivered, so the platform itself has a lot of dexterity to be levered across other indications.”

FDA AUTHORIZATION BY CEDR: Respira is pursuing FDA authorization by CEDR as the first inhalable prescription smoking cessation therapy and the CEO said it all starts with the fact that smoking is the world’s leading cause of preventable death. “When you ask a smoker in 2022 trying to quit, what is the way you will try to quit, the number one method that a smoker will use to quit is to go cold turkey,” he said. “That’s a reflection on the fact that smokers know they tried everything out there and they know that they don’t work.” On top of that, Quigley said, smokers have products like e-cigarettes, which have significantly lower levels of carcinogens, but also still have low levels of potentially harmful constituents. “One of the things that is foundational to who we are is that our technology, because it uses no heat, can satisfy FDA CERS standard for safety,” he said. “Because there is no heat, there are no thermal byproducts. We feel that consumers need to have the option to have a truly safe method to have a therapy prescribed by a doctor that will help them quit and ultimately break their chain of addiction to nicotine.” Millions of consumers in the U.S. are in a dire circumstance looking for a solution, the CEO said, and Respira believes that the CEDR pathway is the best opportunity to bring new technology to those smokers. “The first milestone we crossed was at the end of last year, the pre-IND meeting,” he said. “In that meeting we agreed with FDA to our safety non-clinical study plan and got very good feedback from the FDA on our clinical plan as well. We are going to be having our IND submission, which is our next milestone, in the second quarter of next year and then we will begin our human clinical studies immediately after that meeting.”

Respira is currently wrapping up inhalation toxicity studies to prove safety to show exposure to its product does not lead to any unknown potential harm, the CEO said. “Then efficacy is proven through the clinical studies,” he said. “In those clinical studies, what we will first demonstrate is at what level do we deliver nicotine to that patient. That’s proven in a pharmacokinetic study and then from there we may move into a dose-ranging study, where patients will use the therapy as prescribed.” That study will focus on proving efficacy, Quigley said, which is ultimately how much smokers at the end of the study are able to quit and stay tobacco free and smoke free after wrapping up the therapy. “The efficacy rates of over-the-counter patches and gums are in the mid-single-digits, meaning for every 100 people that start that therapy in a clinical study, only five to seven will successfully quit,” he said. “What that clinical study will show is what does the relationship look like for smokers who use our therapy. Our goal is not just to move the needle and have 7-10% efficacy but to have significant, improvement of efficacy.” The CEO also said Respira has raised $12M to date and is in the process of closing a Series A, which will fund the company through its Phase I clinical trial. “In 2023 we will have to raise more capital to complete our Phase 2 and Phase 3 human clinical studies,” he said. “But we’re funded today through the Phase I clinical, which is a really important, foundational clinical milestone.”

CHALLENGES: When asked about the largest hurdles facing the biotech industry, Quigley pointed to the misalignment of capital with the highest needs for patients. “The statistics show almost half of all new drugs that are approved by the FDA actually start in companies like Respira, that are early-stage risk takers, because the FDA believes that it’s very important that patients get these treatments,” he said. “The large companies must focus their resources on fewer high-priority, high-cost new drug development processes. Making sure that the capital is allocated to and aligned to what those high-priority public health needs are is one of the big challenges.” The CEO noted there are also other obstacles like balancing prescription drug prices for broad availability with the ability of a company to bring in revenue. “It needs to be robust enough that the companies like Respira and other biotechs have enough capital to actually pay back all the investments made to actually develop these drugs and get them to market,” he said.

OPPORTUNITIES: When discussing the biggest opportunities in the biotech space, the CEO said he sees the largest value in applying new technologies to help patients have better outcomes. “My dad was, I called him a life-long quitter,” he said. “He smoked cigarettes his entire life and every year he would tell us, I’m going to quit smoking and he would fail. That’s just an example of all of us in the biotech space, we do what we do because we have those stories and personal experiences.” Quigley added personal experience with afflictions and the pain they create have lead to a very robust front-end innovation space in the biotechnology. “We all try to help to save and improve people’s live and that’s to me what is most exciting,” he said. “It’s not just up to the ten largest pharmaceutical companies in the world, it’s up to every company that has had a personal experience with an affliction to create innovation to help improve on people’s lives.” Additionally with the advancements of technology, the CEO said there is massive opportunities to help people be healthier. “That’s exactly why we’re so passionate and focused on nicotine replacement therapy,” he said. “It is one space, where we know there is a void and we can help save peoples’ lives and hopefully give them a chance to break free from the addiction.”

Publicly traded companies in the tobacco and nicotine products space include Altria Group, British American Tobacco (BTI), Imperial Brands (IMBBY), 22nd Century (XXII) and Philip Morris (PM).

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