How do you deal with a problem like Respira? For this health tech company, which must compete with so many similarly named companies and drugs, the remedy is simple: out with the old, and in with the new.

And that new name—in what would be a brilliant Scrabble-scoring word if it were allowed—is Qnovia, about as far away from Respira as you can get. That ends the four-year history of the health tech company as it officially rebrands, with an accompanying new website and corporate refresh.

The rebrand comes as the California-based company looks to become the first prescription inhalable smoking cessation therapy, which Qnovia sees as an upgrade to nicotine replacement therapies. It’s all still early-stage, but the company is nearing an FDA submission to start clinical trials and is going about seeking new cash to support those trials.

There are simply “too many Respiras including at least two other health tech companies, as well as an air-purifying garden and a carbon credit company,” a Qnovia spokesperson told Fierce Pharma Marketing.

He said the rebranding became necessary “to avoid confusion,” especially as Qnovia moves from that quiet preclinical period and into the more public clinical trial stage.

This is also a big branding move from Brian Quigley, who stepped up as the new CEO of the company just last month. Quigley was previously the chief operating officer and before that an executive at Altria Group. He took over from founder and former chief Mario Danek, who moved down to become its CTO.

“This rebranding will further differentiate the company’s technology and products from others in the biotechnology space,” the company said in a press release.

This is the second life science company name change this month, coming just a week after COVID drugmaker Adagio changed its name to the equally baffling Invivyd amid a series of setbacks in its pipeline this year.

LOS ANGELES–(BUSINESS WIRE)–Respira Technologies, Inc.—a clinical-stage company developing inhaled therapeutics for smoking cessation and drug delivery technologies to treat cardiopulmonary diseases—has rebranded as “QNOVIA” and adopted Qnovia, Inc. as its corporate name. As part of the rebranding, the company has migrated to a new website (https://www.qnovia.com).

The company is advancing to an IND submission and is securing financing for human clinical trials. As the company advances, this rebranding will further differentiate the company’s technology and products from others in the biotechnology space.

This news follows the recent appointment of Brian Quigley as CEO of the company. Previously, Quigley served as COO. Quigley is a former executive at Altria Group, Inc., where he worked for 16 years. For seven of those years, Quigley served as President & CEO of Altria’s Smokeless and Innovative Products/Vapor Businesses. Quigley has over 15 years of business leadership experience in driving innovation and shareholder returns in regulated industries.

About Qnovia, Inc. (formerly Respira Technologies, Inc.)

Qnovia, Inc. is a health tech company focused on commercializing proprietary inhalation device technologies to improve patient outcomes. The company is currently engaged with FDA CDER to pursue a combination product authorization as the first inhalable prescription smoking cessation therapy.

The company was founded by Mario Danek in 2018 to build cutting-edge drug delivery platforms that improve patient outcomes through superior device technologies.

The company’s key product, the RespiRx™ device, is the first orientation-agnostic, portable VMN device that effectively operates in any position held by the patient. Qnovia sees significant opportunity to utilize its drug delivery technologies to improve the treatment of Asthma, COPD, Vaccine Delivery, Pain Management, and several generic as well as select investigational new drugs with safe and effective inhalable drug delivery mechanisms that only the RespiRx™ device can deliver.

Qnovia, Inc. is backed by Blue Ledge Capital, DG Ventures, Evolution VC Partners, Gaingels, Poseidon Asset Management and TL Capital Group LLC.

Contacts

Investor Relations:
Qnovia, Inc.
kiki@gilmartinir.com

Media Relations Contact:
Richard Laermer
RLM PR
212-741-5106 X 216
Qnovia@RLMpr.com

Aerosol-focused biotech startup Respira Technologies is gearing up for the start of its first human clinical trials and has appointed Brian Quigley as the new chief executive to lead the company through this important phase.

Quigley previously served as Respira’s chief operating officer after joining the Century City company in July 2020. He spent 16 years with Altria Group, during seven of which he served as president and chief executive of the tobacco company’s smokeless and innovative products/vapor businesses. Altria ranked No. 165 on this year’s Fortune 500 list.

Respira’s former chief executive, Mario Danek, who founded the company, will be transitioning to the role of chief technology officer. The strategic move will allow Danek to focus on the technology behind Respira, giving special focus to refining and developing the company’s inhalation device, RespiRX, across multiple potential indications that include the treatment of asthma, potential vaccine delivery, pain management, nicotine replacement therapy and inhalable insulin.

New role

The change in executive structure will involve Quigley retaining some of the same duties he had as chief operating officer, such as overseeing commercial strategy, while tending to new responsibilities like fundraising and preparation for filing Food and Drug Administration submissions.

“Our ability to get this application developed and approved by the FDA is now being driven by (me) and it frees up Mario to continue to expand the (intellectual property) portfolio and expand other applications of the technology,” Quigley said.

The company is engaged with the FDA’s Center for Drug Evaluation and Research (CEDR) to pursue a combination product authorization for the RespiRX device and the drug that will be delivered through the device. Respira says the device and drug, which has nicotine as an active ingredient, would be the first inhalable prescription smoking-cessation therapy.

“Although both (the drug and device) may be approved separately, the act of combining the two sides means that you have a product and you’re (conducting) studies to show that the two products can work together with zero or minimal side effects,” Ahmed Enany, president and chief executive of the Southern California Biomedical Council, said.

A regional biotech company that has already navigated the FDA’s combination product-authorization process is Westlake Village-based MannKind, which produces an inhalable, dry-powder insulin that can be administered by a handheld device. The company’s road to FDA clearance took years to complete.

“The challenge there was that their clinical trials were turned down by the FDA two times, and they had to do a longitudinal study in order to show that the (treatment) did not create cancers or other long-term pulmonary issues,” Enany said.

Respira has spent a significant amount of time talking to smokers who have tried to quit, failed, and are looking for new therapies, according to Quigley.
“They’re urgently yearning for a new way because they’ve tried everything,” he said.

“They’ve tried the gums, they’ve tried the patches, they’ve tried the other prescription products and ultimately, they fail and they go back to smoking.”
Quigley added that Respira is focused on developing RespiRX to provide high efficacy rates.

Small, portable device

The RespiRX device is the brainchild of Danek, who sought to create a small, portable, battery-operated therapeutic device. Another part of the device includes a cartridge filled with a liquid treatment that could be easily put in and taken out.

Now, ahead of its developmental and regulatory journey, the device is a pocket-size vibrating mesh nebulizer with a digital interface that keeps track of doses. The RespiRX also will also have Bluetooth-enabled mobile app functionality and will not require cleaning or maintenance.

The company’s next step with the FDA is gaining approval for an investigational new drug submission, which should occur next year according to Quigley. Respira is prepping for human clinical trials to begin early in summer of next year and run into 2024.
In 2025, the company expects to receive approval for its new drug application.

With such a treatment being developed in the company’s pipeline, the need for capital has followed suit. As of late August, Respira raised $12 million in funding. The company received backing from Poseidon Asset Management, Evolution VC Partners and DG Ventures, according to its website.

“We constantly have to balance our investment dollars, make sure we’re allocating our capital to collect the data we need and continue to get closer to each of the next milestones we have to go through with FDA,” Quigley said.

He added that the company is in the process of closing a Series A funding round.
According to a document filed Aug. 5 with the Securities and Exchange Commission, Respira is raising $24.1 million in funding, with nearly $6 million left to be raised. The names of investors were not disclosed.

“Either they will close the round at $24 million or they (will) keep it open to raise the extra six,” Enany said. It is unclear if the $24 million is explicitly for the Series A round.
Further details of the funding round are expected to be shared in the next month, according to Quigley.

“Then there will ultimately be another raise that will probably launch in 2023 to fund our phase two and phase three human clinicals through approval,” Quigley said.