TORONTO, CANADA — (October 25, 2016)
To my fellow Shareholders,
The recent success of our lead drug, ATB-346, in its initial Phase 2 clinical trial has inspired a sense of renewed vigor as we march closer to a potential monetization event. In addition, October marks the 1-year anniversary of our transformation into a revenue-generating company through the acquisition of Citagenix, our commercial regenerative medicine division. For both of these reasons, we thought it would be a great time to reflect on our achievements over the past year and communicate our strategy for next year and beyond.
The clinical development and strategic planning performed in the 2016 calendar year to-date has been paramount in positioning us to deliver significant value to our shareholders over the next 12-18 months. In 2017, ATB-346 will be initiating two larger Phase 2 clinical studies to support a potential partnering event with a global pharmaceutical company within 18 months. ATB-346 has the potential to safeguard the health of and reduce pain for hundreds of millions of people around the world and, in doing so, deliver significant value to our shareholders. Our commercial division, Citagenix, had 2015 revenues of $10 million and is poised for global growth as we embark on our market share expansion strategy in the United States and other markets with the support of a senior sales management layer and an innovative e-commerce platform.
We are very proud of the support that our shareholders have given us over the last few years and feel that their patience will be rewarded in the near-term as we work towards our goal of bringing new, safer drugs to market and building a class-leading offering in regenerative medicine.
Milestones & Progress Achieved in Past Twelve Months
Successful Completion of Initial Phase 2 Clinical Trial
In August 2016, we successfully completed our first Phase 2 clinical trial for ATB-346 in patients with osteoarthritis (“OA”) of the knee. ATB-346 showed pain relief nearly double that of naproxen and celecoxib based on comparable studies, the leading drugs in the market for treating OA. This was a critical study to assess the effectiveness of ATB-346 at a dose of 250 mg, one-sixth of our originally anticipated human dose. The results supported our hypothesis that ATB-346 is much more potent and long-lasting than had been predicted from animal studies. Highlights from the trial include:
- Efficacy data well beyond expectations: ATB-346 produced a reduction of the WOMAC pain score of 7.6 units on day 10 compared to the ~4 unit reduction typically seen (and widely published) by market-leading drugs for osteoarthritis.
- Once-daily dosing: ATB-346 was very effective with a once-daily dosing regimen versus typical twice-daily dosing seen with common pain medications for OA; once-daily dosing is a sought-after characteristic due to its convenience and positive impact on patient compliance.
- Safety: The drug was safe and well tolerated.
Confirmed Non-Addictive Properties of Second Pipeline Drug, ATB-352
Antibe recently completed pre-clinical studies that demonstrated ATB-352, unlike opiate drugs, does not bind to opioid receptors and therefore does not pose a risk of addiction. Opiates, such as oxycontin and fentanyl, are among the most widely used drugs to relieve severe pain, with annual sales exceeding US$7 billion. However, these drugs carry a high risk of addiction and abuse. As earlier announced, Antibe is developing ATB-352, a novel hydrogen sulfide-releasing analgesic, to address the growing need for a powerful but safe and non-addictive acute pain-killer.
Demonstrated Anti-Cancer Potential of Lead Drug, ATB-346
In experimental studies published this year, ATB-346 was shown to be very effective in reversing colon and intestinal tumour growth in mice, and also delivered promising results in the chemoprevention and treatment of melanoma in mice. Although we remain focused on our ongoing human studies to advance ATB-346 as a treatment for pain and inflammation, we are encouraged by these results and plan to continue this research in support of the potential advancement of ATB-346 into selected cancer indications.
Re-positioned Citagenix onto Global Growth Trajectory
Antibe’s commercial division, Citagenix, has become the market leader in the dental regenerative medicine industry in Canada due to its high-knowledge approach and portfolio of quality products and brands. These strengths are being leveraged to replicate Citagenix’s success in Canada on a global scale. Over the last 12 months Citagenix has re-positioned its focus on global growth via two main initiatives: strategic footprint expansion and portfolio expansion. We are now beginning to execute this strategy and believe the next few years will see considerable growth in sales and profitability.
- New product launches. Products launched this year include Neomem® FlexPlus, a high-performance barrier membrane for oral surgery and the PentOS OI™ family of bone graft substitutes.
- Launched U.S. growth initiative. Provided Citagenix with strategic capabilities to ramp up growth in the largest market for dental biologics, estimated to be US$341 million in 2014 (iData Research).
- Evaluating internal development opportunities. We are evaluating two internal development opportunities that have best-in-class potential, low development costs and fast timelines to market (6-12 months).
Strengthened our Board & Governance
In July of this year, we welcomed the addition of Yung Wu to the Board, who is serving as an independent director. Yung is Managing Director of private equity firm NFQ Ventures and is a seasoned entrepreneur with a track record of successfully building and growing several businesses throughout his career. As a serial founder and CEO, he has personally built 7 companies and produced multiple successful exits to acquirers such as Upsight and Oracle Financial Services. He also serves as a director on the Board of Green Shield, a multi-billion dollar health benefits insurance and financial services company.
Strengthened our Balance Sheet
In June 2016, we closed a private placement yielding gross proceeds of $1.5 million, bringing the total amount raised in the last 12 months to $4.5 million.
Primary Activities for the Next Twelve Months
Initiate Two Additional Phase 2 Trials for Lead Drug, ATB-346
We are gearing up to initiate two larger Phase 2 clinical studies to support our goal of reaching a partnering event with a global pharmaceutical company within 18 months. The first Phase 2 study will be a placebo-controlled dose-ranging trial to determine the lowest effective dose of ATB-346. The second Phase 2 study will validate the GI safety advantage of ATB-346 versus naproxen, one of the most widely used medications for treating osteoarthritis. These clinical studies are important for our global partnering strategy and Antibe intends to judiciously engage large, global pharmaceutical firms in dialogue upon completion of these trials.
Pre-clinical Studies for Second Pipeline Drug, ATB-352
There is an urgent need for a safer, non-addictive pain-killer for severe pain in the wake of a surge in drug overdose deaths related to opioid abuse. Antibe recently confirmed the non-addictive properties of ATB-352, a ‘stronger’ NSAID, targeting the significant market for severe, acute pain. Antibe is presently evaluating the clinical development strategy for ATB-352 and, due to its short-term use, anticipates its development timeline will be considerably accelerated as compared to that for a chronic-use drug such as ATB-346. We anticipate commencing pre-clinical toxicology studies next year.
Pursue Partnering Opportunities with Regional Pharma
Antibe is strategically seeking regional partnering opportunities to provide non-dilutive sources of funding and monetize its drug platform through royalty and milestone revenue. Antibe is presently in active discussions with pharmaceutical companies in regions that represent smaller market opportunities (i.e., outside of the United States and the ‘big five’ of Western Europe).
Continue to Execute Citagenix Global Growth Strategy
Citagenix is now poised to grow its global market share and we are genuinely excited about 2017 and beyond. Earlier this month we launched a U.S. growth initiative that is essential to our footprint expansion strategy; we now have the first set of tools to effectively compete and grow market share in the most important market for dental biologics and expect to see our U.S. sales ramp through 2017. In addition, while we will continue to source and in-license high-quality biologics, we are cultivating a new focus on higher-return proprietary opportunities. We have identified two new product opportunities that have best-in-class potential and could see regulatory clearance in 2017.
Growing Shareholder Value
We believe that tremendous value of Antibe resides in our patent-protected, independently-validated hydrogen sulfide-releasing technology and the quality of the science behind our pipeline and drug development platform. We also believe that 2017 will be a pivotal year for our lead drug, ATB-346, as we initiate two more Phase 2 studies to support a potential global partnering event within 18 months. Furthermore, we have augmented the risk-return profile of Antibe through the acquisition of our revenue-generating commercial division in regenerative medicine. Antibe remains unique in the Canadian capital markets as a biotechnology company with blockbuster potential that is de-risked by a commercial platform poised for global growth.
Thank you for your ongoing support.
Daniel Legault, CEO
About Antibe Therapeutics Inc.Antibe develops safer medicines for pain and inflammation. Antibe’s technology involves linking a hydrogen sulfide-releasing molecule to an existing drug to produce a patented, improved medicine. Antibe’s lead drug ATB-346 targets the global need for a safer drug for chronic pain and inflammation. ATB-352, the second drug in Antibe’s pipeline, targets the urgent global need for a safer, non-addictive analgesic for treating severe acute pain, while ATB-340 is a GI-safe derivative of aspirin. www.antibethera.com
Antibe's subsidiary, Citagenix Inc. ("Citagenix"), is a leader in the sales and marketing of tissue regenerative products servicing the orthopedic and dental marketplaces. Since its inception in 1997, Citagenix has become an important source of knowledge and experience for bone regeneration in the Canadian medical device industry. Citagenix is active in 15 countries, operating in Canada through its direct sales teams, and internationally via a network of distributor partnerships. www.citagenix.com
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Forward-Looking InformationThis news release includes certain forward-looking statements, which may include, but are not limited to, the completion of monetization events, the development of drugs and medical devices, the execution of clinical trials, the conclusion of partnering or other relationships with pharmaceutical companies, the execution of market share and portfolio expansion plans, the existence of internal development opportunities, the adherence to proposed development timelines, and the completion of financing transactions. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking, including those identified by the expressions "will", "anticipate", "believe", "plan", "estimate", "expect", "intend", "propose" and similar expressions. Forward-looking statements involve known and unknown risks and uncertainties that could cause actual results, performance, or achievements to differ materially from those expressed or implied in this news release. Factors that could cause actual results to differ materially from those anticipated in this news release include, but are not limited to, the Company's ability to secure additional financing, its ability to execute its business strategy and successfully compete in the market, its ability to conclude partnering or other relationships with pharmaceutical companies, the receptiveness of customers to the Company's products, the capacity of the Company's products to function as anticipated and risks associated with drug and medical device development generally. In making the forward-looking statements in this news release, the Company has assumed that it will be able to secure additional financing, it will be able to execute its business strategy and successfully compete in the market, it will be able to conclude partnering or other relationships with pharmaceutical companies, customers will be receptive to the Company's products, and the Company's products will function as anticipated. Antibe Therapeutics Inc. assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those reflected in the forward-looking statements except as required by applicable law.
Contact InformationAntibe Therapeutics Inc.
Chief Executive Officer
Tel: +1 416-473-4095