SaNOtize Secures $24 Million in Series B Funding to Advance NO Nasal Spray for COVID-19 Prevention

Recently, Canadian biopharmaceutical company SaNOtize announced the completion of a $24 million Series B financing round. This round was co-led by Horizons Ventures and OurCrowd, with ABC International (ABC International Co-investment. This funding will be used for the ongoing development of nitric oxide nasal spray (NONS^TM) Phase 3 trials and other studies for the prevention of SARS-CoV-2 infection.

Although drugs and vaccines have mitigated the impact of COVID-19, SaNOtize believes that better approaches are still needed to prevent and treat SARS-CoV-2 infection. Dr. Gilly Regev, Chief Executive Officer, stated, “Our clinical studies have found that even during the surges of the Delta and Omicron variants, NONS^TMIt is also safe and effective for the prevention and treatment of COVID-19.”

This Vancouver-based company is dedicated to applying the antimicrobial properties of nitric oxide (NO). By utilizing its proprietary NO-releasing solution (NORS^TM), SaNOtize has attempted to apply NO in the manufacturing of sprays, body washes, irrigants, gels, and creams.

SaNOtize's Proprietary Liquid Formulation NORS^TMIt is a nitric oxide (NO) delivery platform that can be used not only for the release of NO gas but also for the preparation of NO-loaded gels or creams. As a non-antibiotic antimicrobial agent, it is effective against bacteria, viruses, and fungi.NORS^TMIt can clear a broad spectrum of infectious pathogens through its delivery mechanism and reduce the frequency of antibiotic use.SaNOtize hopes that this technology will slow the development of antimicrobial resistance (AMR) and reduce the transmission of respiratory infections.

NO is a nanomolecule produced by various human cells and participates in many critical physiological processes, such as cardiovascular health and immune responses. For over two decades, the medical community has been exploring the therapeutic boundaries of gaseous NO. Among these applications, the treatment of respiratory failure in premature infants via delivery through large gas cylinders and ventilators is relatively common.

Meanwhile, NO has also been proven to be a highly effective antimicrobial agent capable of killing viruses, bacteria, and fungi, including SARS-CoV-2, the virus responsible for COVID-19. However, delivering gaseous NO via gas cylinders is impractical for treating many infectious diseases, particularly those that are localized.

SaNOtize is based on NORS^TMThis patent has developedNONS: A Nasal Spray Product Unrestricted by Usage Scenarios^TM, the product portfolio includes VirX^TMand Enovid^TM, targeting the domestic and international markets for COVID-19 treatment respectively. When the spray is released from the nozzle tip, it generates a controlled dose of nitric oxide (NO), which blocks the ACE-2 receptors required for viral entry into cells and disrupts coronavirus variants. Phase 3 clinical studies of NONS™ for the treatment of COVID-19 have found that,It can reduce the SARS-CoV-2 viral load by more than 94% within 24 hours and by more than 99% within 48 hours.

In April 2022, SaNOtize conducted a retrospective clinical trial of NONS™ for the prevention of COVID-19. They found that the infection rate among participants using NONS™ was 6.4%, compared with 25.6% in the control group (P<0.0001).Demonstrate that the drug can reduce the risk of infection by 75%.Currently, SaNOtize plans to recruit 4,000 volunteers in Canada and Sri Lanka for a Phase III clinical trial to evaluate the safety and efficacy of NONS™ as an antiviral agent for the prevention of COVID-19 infection.

VirX^TMand Enovid^TM

Image source: SaNOtize official website

Coronaviruses spread to the nasal mucosa via airborne droplets, replicate during a three-day incubation period, destroy nasal mucosal cells, and are then carried by nasal secretions to the lower respiratory tract, leading to viral pneumonia. Vaccination is the primary preventive measure, but it takes time for the majority of the public to complete vaccination. Additionally, mutant strains of the virus may emerge, and the duration of immune protection remains unclear. For these reasons, it is crucial to identify and provide simple, safe, and universally accessible over-the-counter solutions as soon as possible.

Some pharmaceutical companies in North America and Europe are conducting clinical trials on the use of nitric oxide (NO) to treat patients with severe COVID-19. Among them,SaNOtize's solution is easy to use and low-cost, available in a two-pack.enovid^TMThe selling price is $125.“This simple treatment will help us return to normal life. Even if we inhale the virus, we can prevent and eliminate it by using SaNOtize regularly,” said Rob Wilson, a former UK government minister.

SaNOtize was founded by Gilly Regev and Chris Miller in 2017.

Gilly Regev, CEO and Co-Founder, earned her Ph.D. in Biochemistry from the Hebrew University of Jerusalem. She has 30 years of R&D experience in biochemistry, analytical chemistry, and microbiology, with the past 12 years focused on nitric oxide, including serving as Chief Scientific Officer at Bovicor, an animal health company. Additionally, she is a seasoned biotechnology executive with extensive expertise in drug development, intellectual property strategy, early-stage biotech fundraising, licensing transactions, and clinical trials.

Dr. Chris Miller, Chief Scientific Officer and Co-Founder, brings experience in fundraising and licensing for nitric oxide biotechnology startups, along with 20 years of expertise in clinical trial design, intellectual property, regulatory affairs, and management. Additionally, he serves as a retired Assistant Professor in the Division of Respiratory and Infectious Diseases at the University of British Columbia Faculty of Medicine.

Chris Miller (left) and Gilly Regev (right)

Image source: The Jewish Chronicle

In 2020, SaNOtize received a $400,000 grant from the National Research Council. Subsequently, SaNOtize submitted a series of applications to the Strategic Innovation Fund. In the 2020 federal budget, the fund was allocated CAD 752 million to help Canadian companies develop medical countermeasures against COVID-19 and enhance their clinical trial and manufacturing capabilities.

In August 2021, Glenmark entered into an exclusive long-term partnership with SaNOtize to manufacture, market, and distribute NONS™ in India and several other Asian countries and regions, including Singapore and Malaysia.

In January 2022, SaNOtize and Cytori entered into an exclusive distribution agreement for NONS™ in Japan. Under this agreement, Cytori plans to initiate consultations with the Pharmaceuticals and Medical Devices Agency (PMDA) regarding its regulatory strategy, with the aim of securing approval as early as possible.

In February 2022, the nasal spray received approval from India’s drug regulatory authority and a manufacturing license from Glenmark Pharmaceuticals.

NONS™ is currently marketed and certified as a medical device in several countries, including Israel, Bahrain, and Indonesia. It is also registered as a Class I medical device in Singapore, Nepal, and the European Union, and has obtained the CE mark (European Conformity).

August 24, 2022, SaNOtizeAnnounces completion of $24 million Series B financing to advance the R&D of its nitric oxide (NO)-based products.This round of financing was co-led by Horizons Ventures and OurCrowd,ABC International Co-Investment。“OurCrowd CEO Jon said, ‘We are delighted to participate in this round of financing. As clinical results accumulate and they obtain regulatory approvals in more countries, their products will attract increasing global attention.’”

SaNOtize Financing History

Source: VCBeat

Recently, SaNOtize was shortlisted for the 2022 Fierce Innovation Awards. The awards are co-hosted by Fierce Biotech and Fierce Pharma. A panel of expert judges will select the companies with innovations most likely to impact the pharmaceutical industry based on submissions from enterprises.

SaNotize R&D Pipeline

Image source: SaNOtize official website

In addition to its use in the treatment and prevention of COVID-19, SaNOtize is also exploring nitric oxide (NO)-based therapies for other indications. The company has completed enrollment for its Phase I/II efficacy study on the treatment of chronic rhinosinusitis. Meanwhile, its foot bath therapy for diabetic foot ulcers is currently recruiting patients for a Phase I/II efficacy study funded by the U.S. Department of Defense. Furthermore, SaNOtize received funding in 2018 from the Industrial Research Assistance Program (IRAP) to develop a drug combination for the treatment of onychomycosis.