To my fellow Shareholders,
With our 2013-2014 fiscal year completed, I want to take a few moments to reflect on the past twelve months and to outline our plans for the year ahead. In the last year, we completed our transformation from a private, research-focused, drug-discovery venture into a publicly-traded, commercialization-focused, clinical stage drug development company. We are very proud of the support that our shareholders have given us through this transition as we work to bring new, safer drugs to market.
We are in an exciting stage as we enter clinical trials for our lead drug, ATB-346, with an outstanding team of drug development professionals and a sound balance sheet.
ATB-346 targets the pain and inflammation of arthritis, without causing the gastrointestinal damage that results from today’s most widely-used medications. ATB-346 has the potential to safeguard the health of hundreds of millions of people around the world and, in doing so, deliver significant value to our shareholders.
Significant Milestones in the 2013-2014 Fiscal Year (April 1, 2013 – March 31, 2014)
Completion of Pre-Clinical Studies and Preparations for Phase 1 Clinical Trial
In March 2014, we successfully completed the GLP (Good Laboratory Practice) pre-clinical program for ATB-346 required to seek approval to initiate clinical studies in humans. This program was set out in detail in the Prospectus. We are pleased that we completed it ahead of schedule and on budget. This is a major milestone for any pharmaceutical company.
The pre-clinical work confirmed and expanded upon the extensive body of academic work already conducted on ATB-346. In brief:
- Repeat-dose toxicology studies demonstrated that ATB-346 was very well tolerated in rats and dogs. Both the maximum tolerated dose and the “no observed toxicological effect” dose were at levels greater than three-fold the published dose levels for standard naproxen (ATB-346 is a derivative of Naproxen).
- Genotoxicity studies, including an Ames test, a human lymphocyte chromosomal aberration study and a mouse micronucleus study found no evidence that ATB-346 has mutagenic (mutation-causing) potential.
- Enzyme studies indicate that ATB-346 does not induce or inhibit any of the major CYP P450 enzymes, which should reduce the potential for drug-drug interactions.
- Safety pharmacology studies conducted at dose equivalents well in excess of the anticipated therapeutic level for humans demonstrated that ATB-346 has no toxicologically significant effects on the central nervous system of rats nor any undesirable cardiovascular effects in dogs.
- Chemistry and formulation activities have resulted in a stable, rapid-release tablet formulation that provides near-identical pharmacokinetics and bioavailability to pure ATB-346 drug substance.
We look forward to sharing additional progress with you as we proceed this quarter with an application to Health Canada for permission to initiate the first human trials next quarter.
The Strength of our Science: Founder and Chief Scientific Officer, Dr. John L. Wallace, Receives the Heymans Foundation Memorial Medal
In November, Dr. John Wallace, Antibe’s Founder and Chief Science Officer, was awarded the Heymans Foundation Memorial Medal by the University of Ghent in Belgium. This prestigious award, named after Corneille Heymans, a 1938 Nobel Prize winner for Physiology/Medicine, has been awarded only ten times since being established in 1972. Six of the previous winners are also Nobel Laureates. John was cited for his studies of hydrogen sulfide as an anti-inflammatory agent, as well as the development of new medicines based on those findings through his work with Antibe. All of us at Antibe are very proud of John and happy to see this well-deserved recognition of the value of his scientific contributions.
Strengthening our Balance Sheet
We recently closed a private placement yielding gross proceeds of $4.2M, bringing the total amount raised in the last 12 months to $8.6 million. The company is now fully capitalized through to the completion of Phase I clinical trials for ATB-346, with significant cash reserves.
Primary Activities for the 2014-2015 Fiscal Year (April 1, 2014 – March 31, 2015)
Filing for Phase I Approval
In the current quarter we will be filing an application with Health Canada for permission to initiate the company’s first human trial.
Phase I Clinical Trial
Our primary focus for the current year will be conducting our Phase I clinical trial. The study will be conducted in Montreal by the highly regarded firm Algorithme Pharma Inc. It is a robust, well-designed Phase I, involving integrated single-ascending and multiple-ascending dose studies on 88 healthy volunteers. The Phase 1 trial will also be important for our regional partnering strategy.
Preparation for Phase II Trials
While we are conducting our Phase I trial, we will be performing the important planning and ancillary work required for our rigorous Phase II trial for ATB-346, anticipated for the next fiscal year. The Phase II is also important for our global partnering strategy.
Animal Proof of Concept on Antibe’s Second Drug
We are currently performing proof of concept studies on our second drug, a ‘stronger’ NSAID targeting the significant market for severe acute pain. Our plan is to ready this drug for GLP pre-clinical studies to commence next year.
Strengthening our Governance
We are looking forward to adding an additional independent Director in 2014 to join Walt Macnee, Jonathan Ross Goodman and Rod Flower. Mr Macnee, Antibe’s Chairman, is Vice Chairman of MasterCard Incorporated, and, as its Global President was a key architect of Mastercard’s extremely successful IPO on the NYSE and its subsequent global growth and branding strategy. Jonathan Ross Goodman is the founder and former CEO of Paladin Labs, which was acquired by Endo for approximately $2.7 billion, and the founder and CEO of Knight Therapeutics, which recently raised $180 million and completed its TSX listing. Jonathan’s success in Canada’s healthcare sector has few parallels, and he lends invaluable insight and mentorship. Dr. Flower, a Fellow of the Royal Society, is an internationally respected pharmaceutical scientist with a deep knowledge of Antibe’s area of focus.
Growing Shareholder Value
The 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. Our approach is underpinned by basic research that spans three decades, encompassing fundamental scientific discoveries that have reshaped the understanding of the role played by hydrogen sulfide in biological systems. I am particularly proud of the talented, experienced team we have assembled to advance our drug development program. We believe Antibe is unique in the Canadian capital markets as a development-stage pharmaceutical company with a lead asset targeting a very large worldwide market and a number of follow-on products based on our proprietary hydrogen sulfide-releasing technology.
As a relatively new public company, the Board and management team of Antibe are committed to a high level of continuing engagement with our shareholders. We welcome your questions and input at any time on any aspect of the business – I can be reached directly at firstname.lastname@example.org or at 416.473.4095. You can also follow us on Twitter at twitter.com/antibethera.
Thank-you for your ongoing support. I hope to see you at our second Annual General Meeting on Monday, September 29, 2014 at 10:00am EST, at the offices of Norton Rose Fulbright, Royal Bank Plaza, South Tower, Suite 3800, 200 Bay Street, Toronto, Ontario.
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 growth of product sales, engaging new distributors and independent representatives, the completion of financing transactions and the licensing and development of drugs and medical devices. 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 inability to execute its business strategy and successfully compete in the market, and risks associated with drug and medical device development generally. 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