Hale Therapeutics

ProblemSmoking is killing nearly 8M people globally every year, and 30M Americans are looking to quit with limited success. Nearly 5 decades of medical research has failed to produce a pharmaceutical intervention that leads to permanent smoking cessation in even a substantial minority of users. E-cigarettes (or vaporizers) have contributed to a whole new generation becoming addicted to nicotine, and we believe there’s no solution on the market for them. SolutionHale is working to finally introduce a solution that is disruptive to current Nicotine Replacement Therapies like the gum and the patch. Our design-patented dual-capsule medical vaporizer is designed to automatically and gradually wean people off of nicotine, minimizing withdrawal symptoms. Imagine giving a smoker, or vaper, a device and saying, “Hey, just smoke this and it’ll help you quit.” We think there’s nothing less burdensome.The vaporizer pairs with a mobile application to target both the psychological and physiological aspects of addiction - gradually decreasing nicotine while providing digital therapy support. This removes the pressure from the user to manage their addiction alone.TractionWe have raised about $2M through grants and Pre-Seed rounds from notable investors, including Village Global (a fund backed by Jeff Bezos & Bill Gates). Our team has built out the hardware and software, and ran a battery of preclinical tests for harmful carcinogens that were analyzed to show the Hale product has a 99% reduction in estimated lifetime cancer risk compared to cigarettes. We have met with both the MHRA (UK) and FDA in regards to our potential paths to regulatory approval. Notably, the MHRA is supportive of our plan/solution and we believe we can get to market in the UK rapidly and use the clinical data gathered there to potentially accelerate US approvals.

Investors who invest between $5,000 and $9,999 by Friday, March 18th at 11:59 PM ET will be provided 1 device free of cost  along with a lifetime subscription to our mobile app.

Investors who invest between $10,000 and $49,999 by Friday, March 18th at 11:59 PM ET will be provided 1 device and a 12-month supply of capsules free of cost, along with a lifetime subscription to our mobile app. 

Investors who invest $50,000 and over by Friday, March 18th at 11:59 PM ET will be provided 5 devices and a 12-month supply of capsules free of cost for 5 people, along with lifetime subscriptions for each person to our mobile apps. You will also be given access to the founders during a one-day offsite at a time and place of your choosing.

It is advised that you consult a tax professional to fully understand any potential tax implications of receiving investor perks before making an investment.

Please note that due to share price calculations, some final investment amounts may be rounded down to the nearest whole share - these will still qualify for the designated perk tier. Additionally, investors must complete the online process and receive an initial email confirmation by the deadline stated above in order to be eligible for perks.

Raised $1.98M in Pre-Seed rounds from key investors including Village Global, The Venture Collective, Ben Franklin Technology Partners, Monozukuri Ventures, Backstage Capital, Todd Jackson (First Round Capital), and Peter Moran (DCM).

Met with both the FDA and MHRA (UK) in regards to paths to regulatory approval. MHRA has provided positive advice on preclinical and clinical plan, providing a potential path to approval in the UK. The company target for this plan to approval is 24 months.

Key advisors include Dr. Thomas Brandon (Chair, Moffitt Cancer Center Department of Health Outcomes & Behavior - Tobacco Addiction), Dr. Seth Goldenberg (VP, Veeva; ex-Regulatory Chemist, FDA), and Dr. Rick Pescatore (Chief Physician, Delaware Division of Public Health).

Preclinical toxicological testing was analyzed to show up to 99% reduction in estimated lifetime cancer risk as compared to combustible cigarettes, which can potentially de-risk upcoming testing for regulatory submissions in the UK & US.

Three patent applications filed for the vaporization device and smoking-cessation apparatus; and a design patent granted for the dual-capsule vaporizer apparatus design.

Village Global
The Venture Collective
Monozukuri Ventures
Backstage Capital
Quake Capital
Ben Franklin Technology Partners
NextFab
Peter Moran
Investor, ex-DCM General Partner

Deb Conway
Investor, Acme Capital

Sheel Mohnot
Investor, Better Tomorrow Ventures

Todd Jackson
Investor, First Round Capital

Dr. Thomas Brandon
Advisor, Tobacco Dependence, Moffitt Cancer Center

Dr. Rick Pescatore
Advisor, Medical, Chief Physician Delaware Division of Public Health

Dr. Seth Goldenberg
Advisor, Regulatory, Ex-FDA

Adam Schoenfeld
Advisor, Operating, Founder Greenlane