Hale Therapeutics Founder Josh Israel Is Determined to Help Smokers Quit

My co-founder, Devin, who I’ve been friends with since 2004 and also previously built a company with, had an unfortunate death in his family where the cause was directly related to smoking. At this time, we had also exited our previous startup and were deciding what we wanted to do in the future. We started to dive into the nicotine replacement therapy (NRT) space and realized that the solutions in the market were ineffective for most smokers, and through nearly five decades of medical research, there had yet to be a pharmaceutical intervention that led to permanent cessation in even a substantial minority of users. We decided that there had to be a way to truly help smokers quit by utilizing technology that was gaining momentum but not being used to solve the actual problem at hand.

The team is made up of myself, Devin, and a few software and hardware engineers. At the moment, we’re backed by a strong advisory board of ex-FDA, tobacco dependence researchers, medical doctors, and successful operators. The team came together through introductions made by friends, investors, and cold outreach! Never doubt a solid cold email.

We’re bringing an innovative approach to the NRT industry. As of right now, all FDA-approved NRTs are either gums, patches, inhalers, or pills. No company has brought an electronic nicotine delivery system, or any technology for that matter, that automatically and gradually reduces nicotine consumption over time based on the type of smoker who is using the product. 

The current competitive landscape is the incumbent brands that have been used for generations that are ineffective: NicoDerm, Nicorette, etc. Using a gum or transdermal patch to attempt to help people quit doesn’t work — it delivers nicotine slowly, and it does not provide the same sensory, physiological, or psychological experience that a combustible cigarette does. By delivering nicotine through heated inhalation, we are mimicking a cigarette almost one to one. Furthermore, we aren’t asking users to go to the store and buy a different dosage of the NRT they are using. We aren’t asking them to chew X pieces of gum. We aren’t saying, “Take these pills that cost hundreds of dollars per month.” We are handling the entire cessation process for them, and we are asking them to do nothing but what they are used to doing: smoking.

In the UK and US, we are seeking approval as a medicinal product — not an e-cigarette. While this may take more time than being approved as a traditional tobacco product, it affords us the opportunity to make claims that other e-cigarettes cannot make and is in line with our vision to create a solution for those who are truly looking to quit. The process, in a nutshell, is to conduct preclinical safety testing (some of which has already been conducted) and then move into clinical trials to test safety and efficacy. In the UK, the process is more expedited as the Medicines and Healthcare products Regulatory Agency does not require us to conduct multiple trials as the FDA does.

The capital we are raising at the moment will be used to submit a clinical trial application in the UK, conduct safety and efficacy trials in order to submit regulatory approval in the UK and move into a phase two study in the United States. This will put us in a strong position by de-risking the regulatory process significantly and enable us to raise a large Series A and bring our solution to commercialization in the US and UK.

This is not our first rodeo. Devin and I have been working and building companies together for close to 10 years. We understand the highs and lows that come with building, and we learn quickly. We are also currently backed by some amazing investors, including Village Global, The Venture Collective, Backstage Capital, Todd Jackson, Sheel Mohnot, Peter Moran, and more.

Ideally, we would like to research additional therapeutic areas that our unique device design and technology can treat. We’ve done some early research with Dr. Rick Pescatore, who is an advisor to our company and the chief physician with the Delaware Division of Public Health. He makes a case for using Hale to treat major depressive disorder and potentially start to research opioid tapering as well. If we can make some headway in these areas in the next five to 10 years, we can create a strong pipeline of additional products and look to bring the company to the public markets or an acquisition from a large pharmaceutical company.