Chrono Therapeutics Announces Appointment of David Happel as Chief Executive Officer

Dr. Alan Levy, Ph.D., to Retire as CEO

Chrono Therapeutics, a pioneer in digital drug therapy, today announced that Alan Levy Ph.D., chief executive officer and chairman of the board of directors is retiring. David A. Happel has been appointed as the new chief executive officer, and current board member James Young, Ph.D., will assume the role of chairman of the board.  Dr. Levy will continue to serve as a member of the board.

"I'm very pleased with the progress we have made over the last four years, including the excellent clinical results in our smoking cessation application as well as the progress we have made on our Parkinson's disease and opioid-tapering programs that target important unmet clinical needs," said Dr. Levy.  "With David's background and experience in both the biotech and pharmaceutical industries, and his focus on commercialization, he is the ideal person to take the company through its next chapter."

"It is an honor to succeed Alan, and I am very excited to build on the foundation that has been created at Chrono Therapeutics as the company continues to advance its proprietary SmartDermal therapeutics and technology platform into the later stages of clinical development and commercialization," said Mr. Happel.

Mr. Happel joins Chrono Therapeutics from Horizon Pharma, PLC where he was executive vice president of commercial development and strategy. During his tenure at Horizon, Mr. Happel was responsible for the commercialization of Horizon's five marketed orphan disease products and the development of Horizon's rare disease pipeline portfolio. Prior to Horizon Pharma, he was the chief commercial officer of Raptor Pharmaceuticals where he had worldwide responsibility for the commercialization of Raptor's two marketed orphan disease products and the development of Raptor's pipeline portfolio. Previously, Mr. Happel held senior management positions at Allergen Research Corporation, Dynavax Technologies, Dr. Reddy's Laboratories, Chiron Corporation and Intermune. Mr. Happel received his B.A. in chemistry from Indiana University and his M.B.A in marketing from Indiana State University.

"On behalf of the entire board, we thank Alan for his endless dedication and commitment to the company over the last four years. Under his leadership Chrono Therapeutics has built a rich pipeline of product candidates to address unmet needs in addictions and central nervous systems disorders with a vision to improve patient outcomes and lives," said James Young, chairman of Chrono's board of directors.

About Chrono Therapeutics

Chrono Therapeutics is dedicated to improving the lives of patients living with addictions and other neurological conditions by combining smart drug delivery, personalized behavioral support, data analytics, and improved compliance into one integrated product. Chrono Therapeutics' transdermal drug delivery platform is smarter: providing just the right amount of medication timed to when patients' symptoms are at their strongest and medication is most needed. With our technology, drug delivery is personalized and has the potential to be significantly more efficacious.

For more information, visit: www.chronothera.com.

Chrono Therapeutics Raises $47.6 Million in Series B Financing to Advance its Clinical Platform for Personalized Drug Therapy

Kaiser Permanente Ventures Leads Round

Hayward, CA – September 8, 2016 – Chrono Therapeutics, a pioneer in digital drug therapy and recent recipient of the World Economic Forum Technology Pioneer Award, today announced that it has closed a $47.6 million Series B financing. The round was led by Kaiser Permanente Ventures and included investments by Endeavour Vision, Xeraya Capital Labuan Ltd, Asahi Kasei, Emergent Medical Partners, Hikma Ventures, Cota Capital, and Mission Bay Capital.

Chrono will use the funding to advance the clinical development of its smoking cessation
platform and investigate other applications that can leverage its personalized drug therapy
platform. In association with the financing, Liz Rockett, Director of Kaiser Permanente Ventures, was named to Chrono Therapeutics’ board of directors. Existing investors including Canaan Partners, 5AM Ventures, Fountain Healthcare Partners, GE Ventures, and Mayo Clinic participated in the round.
 

“Chrono Therapeutics’ platform has the potential to more effectively address nicotine addiction, a leading cause of death and illness around the world and a significant public health challenge,” said Rockett. “According to the CDC, over forty percent of smokers try to quit each year, only a fraction of them succeed. We expect our investment to help Chrono achieve its mission to dramatically improve the tools that help people quit smoking.”
 

Chrono’s platform combines biologically-timed drug delivery, embedded sensor technology to monitor compliance, and connected and personalized behavior change support. The platform’s first application tackles smoking cessation. Timed delivery of medication may offer benefits for other indications, including opioid addiction, Parkinson’s disease, and pain management.
 

“We have made tremendous progress in developing our technology to help people quit smoking, one of the lowest cost ways to improve health and reduce healthcare costs,” said Alan Levy, Ph.D., chairman and CEO of Chrono. “This financing will bring us closer to commercializing our system for smoking cessation and also enable us to dive more deeply into other applications where we can make a major impact and save lives.”
 

Chrono’s wearable transdermal drug delivery device times nicotine delivery to when smokers have their strongest cravings. Studies show that 75% of all smokers reach for their first cigarette within 30 minutes of waking up. The Chrono solution is designed to deliver the first dose of nicotine replacement therapy shortly before the smoker wakes up and to create a pattern of “peaks and troughs” of nicotine delivery throughout the rest of the day to ensure the smoker has more nicotine support when cravings are predicted to be strongest. In a recent clinical trial of adult male smokers, Chrono’s smoking cessation technology demonstrated a clinically meaningful and statistically significant reduction in nicotine cravings.
 

“Chrono’s technology is the first of its kind and holds the potential to significantly improve the way we provide an end-to-end patient-centered solution for those people struggling with addiction and chronic neurological diseases,” said Wende Hutton of Canaan Partners. “We welcome our new investors and look forward to the additional experience and perspective they will bring to Chrono. Kaiser Permanente Ventures’ insights into delivering value-based pharmaceutical offerings to managed care environments and Endeavour Vision’s experience in international markets will add significant value to this exciting company.”
 

About Chrono Therapeutics
Effective care of the most hard-to-treat conditions requires approaches beyond simply taking medicine. Chrono's team is developing a next generation transdermal drug delivery wearable that integrates biologically-timed drug delivery with personalized digital support to help people achieve optimal clinical outcomes and lifestyle improvements. Chrono's first application is in smoking cessation, enabling smokers to overcome the world's deadliest addiction. For more information, visit www.chronothera.com

Chrono Therapeutics' Smoking Cessation Technology Demonstrates Significant Reduction in Nicotine Cravings

Personal smoking cessation therapy combines optimized nicotine delivery, personalized behavioral support and monitoring and compliance

CHICAGO - Chrono Therapeutics, a pioneer in digital drug therapy, today announced that clinical data for the company's smoking cessation technology showed a statistically significant reduction in nicotine cravings in a trial of adult male smokers. The data were presented today at the Society for Research on Nicotine & Tobacco's 22nd Annual Meeting.

Chrono's wearable transdermal drug delivery device times nicotine delivery to when smokers have their strongest cravings. For example, 75% of all smokers reach for their first cigarette within 30 minutes of waking up. The Chrono Solution is designed to deliver the first dose of nicotine replacement therapy (NRT) shortly before a smoker wakes up and then creates a pattern of "peaks and troughs" of nicotine delivery throughout the rest of the day to assure the smoker has more nicotine support when cravings are predicted to be strongest.

"In the United States, 70 percent of smokers want to quit, but quitting is extremely difficult. In fact, most people try 8 to 10 times and this includes quit attempts with standard cessation medications like nicotine patch and gum and prescription drugs like varenicline," said Alan Levy, Ph.D., chairman and CEO of Chrono Therapeutics. "Gums and patches are designed to help manage cravings, but they are only 5 to 9 percent effective. Our goal is to solve this crisis of public health with an innovative, integrated smoking cessation solution, and the data we presented demonstrates that we are on the right path."

The clinical trial was a randomized, double blinded study of 24 adult males who smoked 11 or more cigarettes per day, indicating a high level of nicotine dependence. The subjects were divided into two groups. Test group subjects had nicotine administered over a 30-hour time period via Chrono's prototype device that delivered nicotine according to Chrono's "peaks and troughs" profile. Control subjects had a placebo solution, with no nicotine, administered at the same intervals via the same prototype device. Across both groups, subjects showed no serious adverse events or study withdrawals due to an adverse event. Skin irritation assessment showed no signs of irritation or erythema.

Cravings were assessed via three different methods: the Questionnaire for Smoking Urges (QSU), the Mood and Physical Symptoms Scale (MPSS) and a single craving question, each of which is a validated tool to assess cravings. When compared to subjects treated with placebo, test subjects had a statistically significant and clinically meaningful reduction in cravings for all assessment methods (p=0.035; p=0.034 and p=0.016, respectively).

"Achieving statistical significance in a 24-subject trial is very striking and happens infrequently in biopharma; so these results are very encouraging," noted Wende Hutton, general partner at Canaan Partners and a member of Chrono's board of directors. "Quitting smoking is one of the simplest ways to improve global public health, but as the dismal efficacy of current therapies demonstrates, it is also one of the hardest. I'm very excited to be working with a company that has the potential to solve such a serious problem."

About Chrono Therapeutics

Effective care of the most hard-to-treat conditions requires approaches beyond simply taking medicine. Chrono's team is developing the first wearable transdermal drug delivery device that optimizes drug dosing, is embedded with sensor technology to track usage and is connected via Bluetooth to an evidence-based smartphone application that delivers real-time personalized behavioral support to keep users on track to achieve their goals. Chrono's first application is in smoking cessation, enabling smokers to overcome the world's deadliest addiction. For more information, visit www.chronothera.com.

Media Contact
Margaux Stack-Babich
619-849-5385
margaux@canalecomm.com

Chrono Therapeutics Receives Second Fast Track SBIR Grant from National Cancer Institute for Patient-individualized Smoking Cessation Therapy

HAYWARD, Calif., Chrono Therapeutics, a pioneer in digital drug therapy, today announced it has received a second Phase 1 and Phase 2 Fast Track Small Business Innovation Research (SBIR) grant award from the National Cancer Institute (NCI). This award of up to $2.3 million will support final product development of the digital portion of Chrono's patient-individualized smoking cessation therapy as well as pilot efficacy trials of the system. This is the second Fast Track SBIR grant award Chrono has received from the NCI. Chrono successfully executed on a 2012 $2.23M grant that funded early product engineering and a second in human pharmacokinetic study.

Chrono's smoking cessation solution is the first nicotine delivery system to time medication delivery to when smokers' cravings are predictably strongest. The wearable component automatically begins delivering nicotine before smokers wake up, helping to curb the strong morning craving most smokers experience – something other nicotine replacement products cannot do. Embedded with sensors and Bluetooth, the wearable monitors compliance and securely connects with a companion mobile application that provides real-time behavioral coaching in response to cravings and the nicotine-dosing regimen.

"Receiving our second grant award from the NCI is an endorsement of Chrono's cessation platform, which takes a fresh approach to a serious addiction that kills 5 million people worldwide each year," commented Alan Levy, the CEO and Chairman of Chrono Therapeutics

Dr. Michael Burke and Dr. Taylor Hays of the Mayo Clinic are among several of the world's leaders in nicotine dependence treatment working with Chrono to integrate tailored nicotine delivery with evidence-based, proactive and personalized behavioral strategies to help smokers quit.

"Integrating a smart digital coach that leverages the best in behavioral science with a new and adjustable method to deliver nicotine replacement has the potential to save many thousands of lives by providing new hope and support to people struggling to become tobacco free. We are very excited to collaborate with Chrono on this innovation," stated Dr. Burke, Assistant Professor of Medicine at the Mayo Clinic School of Medicine and Program Coordinator at the Mayo Clinic Nicotine Dependence Center.

The smoking cessation solution is the first product targeted to be commercialized from Chrono's platform, which represents the convergence of optimized drug delivery, embedded sensor technology to monitor compliance, and connected and personalized behavioral support to transform how medicine is delivered and how people achieve their health goals.

Guy DiPierro, the Founder of Chrono and VP of Intellectual Property and Governmental Affairs commented, "We appreciate NCI's ongoing support and leadership in helping Chrono combat one of the world's leading pandemics."

About CHRONO

Effective care of the most hard-to-treat conditions requires approaches beyond simply taking medicine. Chrono's team is developing the first wearable transdermal drug delivery device that optimizes drug dosing, is embedded with sensor technology to track usage and is connected via Bluetooth to an evidence-based smartphone application that delivers real-time personalized behavioral support to keep users on track to achieving their goals. Chrono's first application is in smoking cessation, enabling smokers to overcome the world's deadliest addiction. For more information, visit www.chronothera.com

Chrono Therapeutics Receives Investment from Rock Health to Advance SmartStopTM Smoking Cessation Technology

HAYWARD, California -- Chrono Therapeutics, a pioneer in digital drug products, today announced an investment by Rock Health, the leading seed fund in digital health, to support the advancement of Chrono's SmartStop™ programmable transdermal drug delivery system and real-time behavioral support program for smoking cessation.

Smoking kills more than 500,000 Americans each year, and is responsible for approximately one in five deaths in the United States. Of the 45 million smokers in the US, 70 percent report that they want to quit, according to the Centers for Disease Control, while 23 million try to quit each year. The average smoker will attempt to quit eight to ten times. Nicotine replacement therapy (NRT) is one method used to help smokers quit, but conventional NRT does not match craving cycles, leading to six-month efficacy of less than 20 percent.

SmartStop is a wearable device that offers programmable, transdermal nicotine replacement therapy (NRT) in combination with real-time behavioral support. Research shows that smokers have clear, consistent and predictable daily peak nicotine craving patterns. SmartStop is designed to automatically vary nicotine levels throughout the day to match those patterns. The device uses Bluetooth technology to wirelessly communicate with the SmartStop behavioral support mobile app, providing real-time guidance to help smokers cope with cravings as well as a means for promoting compliance to the NRT and overall quit process.

"Chrono Therapeutics is a leading digital health company developing a truly innovative approach to solve one of the world's most significant public health challenges–the global epidemic of smoking," said Malay Gandhi, Managing Director of Rock Health. "Chrono's SmartStop drug delivery system represents the type of next-generation product technology that Rock Health is seeking to identify and advance in order to significantly impact the future of healthcare. By adopting digital technology to deliver and target treatment along with guided coaching, SmartStop is designed to help smokers quit their addictive, life-threatening habit with a reliable, convenient and effective wearable device."

Rock Health will join Chrono's current investor syndicate, which includes Canaan Partners, 5AM Ventures, Fountain Healthcare Partners, Mayo Clinic and GE Ventures, all of whom participated in the Company's $32 million Series A financing announced in June of 2014.

"Chrono Therapeutics is developing a unique delivery method for nicotine replacement therapy with an automated wearable device integrated with real-time coaching support to help smokers effectively quit," said Alan Levy, Ph.D., CEO of Chrono. "Rock Health's mission is directly aligned with our vision of transforming disease and addiction management through digital health technology, and we're thrilled to have them onboard as an investor."

About Rock Health

Rock Health funds and supports startups building the next generation of technologies transforming healthcare. Find out more at www.rockhealth.com.

About Chrono Therapeutics

Chrono Therapeutics is a pharmaceutical company with a vision of transforming disease and addiction management to become the market leader in programmable passive transdermal drug delivery that offers real-time behavioral support. Chrono's executive leadership combines years of professional experience and personal passions for developing life-saving medical products. For more information, visit www.chronothera.com.

Sagentia selected as lead development partner for Chrono Therapeutics’ wearable ‘smart’ smoking cessation device

Sagentia, a global science, product and technology development company, announced today that it is working with Chrono Therapeutics on the development of SmartStop™, the world’s first programmable and wearable nicotine delivery device to help people quit smoking.

Chrono Therapeutics is a California-based pharmaceutical company with a vision of transforming disease and addiction management to become the market leader in programmable passive transdermal drug delivery (TDD) that offers real-time behavioral support. This past summer, Chrono secured $34M in Series A financing to complete product development and clinical studies for its flagship product SmartStop™, a new and revolutionary wearable device, which offers programmable, transdermal nicotine replacement therapy (NRT) in combination with real-time digital behavioral support that promotes compliance.

To date, many products on the market which aim to help people stop smoking exhibit low rates of success. For example, standard nicotine patches deliver a steady stream of nicotine throughout the day, while nicotine gum delivers spikes of nicotine, but often the doses are too low or compliance is poor resulting in relatively low efficacy in helping smokers to quit.

SmartStop™ offers a novel solution. It is designed to be worn 24 hours a day and to automatically coincide the dose of nicotine that it delivers with the cigarette craving patterns that have been identified in smokers. The device then uses Bluetooth technology to wirelessly communicate with the SmartStop™ digital support program, providing real-time guidance to help smokers cope with cravings and quit for good.

Sagentia was selected as the lead development partner to help Chrono Therapeutics bring the technology to market. Sagentia’s involvement began with concept generation and early feasibility testing to ensure that the product is small enough to wear comfortably and can be manufactured at the right price point. The Sagentia team is now continuing through the full design, miniaturization and development of the electromechanical microfluidic system, including the durable control unit and the nicotine pump delivery system. Key requirements are that the device be low cost and have a small and light design that is attractive to consumers.

Alan Levy, Ph.D., CEO of Chrono Therapeutics, comments: “Smoking costs people their health and eventually their lives, but current technologies like nicotine gums and patches are not effective in enabling smokers to quit permanently because they do not address the cyclical nature of nicotine cravings and offer little to no behavioral support. We believe we have a very compelling technology that will solve many of the problems that make smoking cessation so difficult and working with Sagentia as a product development partner is allowing us to get this to market faster.”

Dr. Gregory Berman, Head of Drug Delivery at Sagentia, adds: “The SmartStop™ technology has the potential to revolutionize the smoking cessation market and make a big difference to peoples’ lives. The compliance aspect of this device is particularly exciting, providing patients with feedback, support and encouragement on their progress.”

About Sagentia

Sagentia is a global science, product and technology development company. Our scientists and engineers redefine what’s possible and help R&D groups achieve commercial return from their most complex technology projects. We have over 27 years’ experience and have successfully completed over 10,000 projects for start-up and global market leader clients alike, across the medical, industrial, oil & gas and consumer sectors.

Our services span the full product development lifecycle, from new concept generation and technology validation, through prototyping and full product development, to transfer to manufacture and sustainability. Sagentia employs over 150 scientists, engineers and market experts and is part of the Sagentia Group, with headquarters in Cambridge, UK and offices in London, Guildford, Boston, Houston and Dubai.

For further information visit us at: www.sagentia.com or email info@sagentia.com

About Chrono Therapeutics

Chrono Therapeutics (CHRONO) is a pharmaceutical company with a vision of transforming disease and addiction management to become the market leader in programmable passive transdermal drug delivery (TDD) that offers real-time behavioral support. Chrono’s executive leadership combines years of professional experience and personal passions for developing life-saving medical products. Steeped with years of experience in product development, science, R&D an understanding of the consumer smoking cessation market, FDA approval experience and bringing life-saving products to market, the team represents a wide-array of knowledge that combined can help address the serious epidemic of smoking.

Background information

Smoking is highly addictive and remains one of the world’s great killers. The World Health Organization estimates that the global death toll is 6 million per year and this is expected to rise to 7 million by 2020. For every death caused by smoking, approximately 20 smokers are suffering from a smoking related disease.

Chrono Therapeutics, Inventor of Wearable “Smart” Smoking Cessation Technology, Secures $32 Million in Series A Financing

Syndicate includes Canaan Partners, 5AM Ventures, Fountain Healthcare Partners, Mayo Clinic and GE Ventures

HAYWARD, Calif – Chrono Therapeutics , a pioneer in digital drug products, announced today the close of a $32 million Series A financing round, led by Canaan Partners and5AM Ventures . Additional participants in the financing were Fountain Healthcare Partners , Mayo Clinic andGE Ventures . The funds will be used to complete product development and clinical studies for the company’s SmartStop™ programmable transdermal drug delivery system and real-time behavioral support program for smoking cessation. As part of the financing, Wende Hutton, general partner with Canaan Partners, Jim Young of 5AM Ventures and Aidan King of Fountain will join Chrono’s board of directors.

“Smoking costs people their health and eventually their lives, but current technologies like nicotine gums and patches are not effective in enabling smokers to quit permanently because they do not address the cyclical nature of nicotine cravings and offer little to no behavioral support,” said Alan Levy, Ph.D., CEO of Chrono. “We believe we have a very compelling technology that will solve many of the problems that make smoking cessation so difficult.”

Smoking kills more than 400,000 Americans each year, and is responsible for approximately one in five deaths in the US. Of the 45 million smokers in the US, 70 percent report that they want to quit, according to the Centers for Disease Control , and 23 million try to quit each year. The average smoker will attempt to quit eight to ten times. Nicotine replacement therapy (NRT) is one method used to help smokers quit, but conventional NRT does not match craving cycles, leading to six-month efficacy of less than 20 percent.

SmartStop is a wearable device that offers programmable, transdermal nicotine replacement therapy (NRT) in combination with real-time behavioral support. Research shows that smokers have clear, consistent and predictable daily peak nicotine craving patterns; SmartStop is designed to automatically vary nicotine levels throughout the day to match those patterns. The device uses Bluetooth technology to wirelessly communicate with the SmartStop digital support program, providing real-time guidance to help smokers cope with cravings as well as a means for promoting compliance to the NRT and overall quit process.

“We have developed a unique approach to the very difficult problem of helping smokers quit their life-threatening habits,” noted Chrono founder Guy DiPierro. “We believe that the blend of a well understood active drug compound in nicotine with a programmable, wearable delivery system that takes into account a person’s habits as well as physiological patterns that each contribute to cravings has the potential to help more smokers quit once and for all.”

Leslie Bottorff, Managing Director of Healthcare at GE Ventures added, “Chrono Therapeutics is paving the way for personal monitoring in healthcare through the creation of the SmartStop integrated digital solution. Their technology is only just beginning, and GE Ventures looks forward to working together to transform disease management.”

“Over the past 20 years, I have had the privilege of backing Alan Levy as CEO in the founding of three life sciences companies,” stated Wende Hutton. “Alan brings an exceptional track record of success in drug/device combination therapies to Chrono.”