– Large market partnering program now underway –
– Limited COVID-19 impact: Phase III program slated to start in second half of 2021 –
– U.S. institutional outreach expanding –
TORONTO, CANADA — (January 11, 2021)
To our shareholders,
As we build on last year’s significant clinical and capital markets achievements and enter the homestretch in the strategic monetization of otenaproxesul, we want to update you on our progress and plans. We are particularly gratified by the recent uptick in interest by both global and regional potential partners, supporting otenaproxesul’s compelling value proposition and revenue opportunity. We are also encouraged by the response to our U.S. institutional outreach, further validating our strategy for unlocking the value of our assets as we move toward a potential listing on a senior U.S. exchange.
Clinical and Scientific Programs Advance
Otenaproxesul’s Phase III preparations remain on schedule. With eight Phase III-enabling animal studies finished and a further two to complete, we have already discharged the bulk of registration trial preparations begun last summer. We also remain on track with CMC (chemistry, manufacturing and controls), an extensive set of activities crucial to late-stage clinical development and commercialization. Our manufacturing partner is in the final stages of tablet production.
As planned, we will be submitting otenaproxesul’s IND (“Investigational New Drug”) application to the U.S. FDA within weeks. In ordinary circumstances, we would then expect to proceed with the adaptive Phase III trial in the upcoming quarter. However, the ongoing rise in COVID-19 infections is increasingly compromising the ability of clinics and hospitals to accommodate large clinical trials, particularly in the U.S. where this trial must take place. With this situation expected to ease later in the year as vaccines take hold, guidance for trial initiation is being adjusted to the second half of 2021. In the interim, and supported by our strong balance sheet, we are taking the opportunity to perform an enhanced version of the previously planned absorption, metabolism and excretion (“AME”) study which is set to begin in Canada this quarter. In addition to providing valuable information for potential partners, this 6-week study (which includes 2 weeks of follow-up monitoring) will further de-risk dose selection for our Phase III program, while also supplying pharmacokinetic data required for drug marketing approval.
Our pipeline’s value and depth continue to grow. Last quarter, we commissioned a market opportunity assessment to guide the detailed development of our second drug, ATB-352, an opioid replacement aimed at the post-operative pain market. The study provided important input for trial design and confirmed the large unmet medical need for a gastrointestinal-safe NSAID for acute pain, projecting peak year sales exceeding US$800 million in the U.S. alone. While stronger nonsteroidal anti-inflammatory drugs (“NSAIDs”) have demonstrated analgesic efficacy comparable to opioids in many settings, they are correspondingly more damaging to the gastrointestinal tract, limiting their use and leaving physicians, payors and policymakers with few options as they address a resurgent opioid crisis.
Leveraging our hydrogen sulfide platform beyond its current focus on NSAIDs, our pipeline expansion initiatives are now generating promising new molecules and fresh intellectual property. Our first candidate for in vivo testing targets inflammatory bowel disease (“IBD”). More than three million U.S. adults suffer from this condition, long in need of safe and more effective first-line treatments. Previous work with hydrogen sulfide-releasing substances has shown encouraging results in animal models of IBD. The development of new molecules is an ongoing process and we hope to announce further progress in the coming months.
Corporate Developments to Drive Value for Partnering and Capital Markets
As anticipated, the attainment of human proof-of-concept for otenaproxesul and promising third party commercial projections are driving new interest by potential partners. Correspondingly, we are intensifying our focus on increasing the value of our assets and improving negotiating leverage. Our efforts include this month’s launch of our large market partnering program, spearheaded by Dr. Rami Batal, our Chief Commercial Officer, and Ella Korets-Smith, our Head of Regional Business Development. As recently announced, we also strengthened our capabilities with the addition of Dr. Don Haut to our Partnering Advisory Team. His 20-year record of healthcare-related business development, including a leading role in AskBio’s recent $4 billion acquisition by Bayer AG offers us rich insight into the dynamics and key players in today’s pharma partnering landscape.
To support our accelerating business development efforts, we have also retained a premier global life science transaction firm. Their first task was an in-depth partner targeting study, identifying and characterizing the most promising 70 global and regional pharma firms with an interest in pain and inflammation. The formal outreach process has commenced and we will report material developments as they occur.
Further supporting our partnering activities and in preparation for a potential listing on a senior U.S. exchange, Antibe recently initiated efforts to unify the intellectual property (“IP”) ownership of our drugs and platform. We believe that full control of the underlying IP would unlock value for potential partners and investors while simplifying IP protection for our pipeline expansion efforts. In addition, we will soon upgrade our current U.S. OTC listing to the “QX” level from its current “QB” designation. These initiatives complement our recent graduation to the TSX, share consolidation and the appointment of U.S.-based directors.
Board of Directors Recognizes Significant Progress with RSU Grants
In view of the achievement of human proof-of-concept for otenaproxesul and commercial validation, the Board of Directors is awarding 2,092,000 restricted share units (“RSUs”) to directors, officers, employees and consultants pursuant to Antibe’s RSU plan. The vesting of 50% of the RSUs granted to key executives will be subject to specific performance goals that reflect the successful execution of Antibe’s business plan, including our monetization strategy. All RSUs are subject to time-based vesting; one third (1/3) of the RSUs granted will vest on each of the first, second and third anniversaries of today’s date. In addition, we have granted BND Projects Inc. 66,000 options for investor relations services. Each option has an exercise price of $4.00, vests quarterly starting on the date of the grant, and will expire January 11, 2024.
We are excited to hit the ground running in 2021, as we embark on the next steps in developing and commercializing a new generation of anti-inflammatory drugs to meet the pressing needs of doctors and patients around the world.
Chief Executive Officer
About Antibe Therapeutics Inc.
Antibe is leveraging its proprietary hydrogen sulfide platform to develop next-generation, safer nonsteroidal anti-inflammatory drugs (“NSAIDs”) for pain and inflammation arising from a wide range of medical conditions. Antibe is developing three assets that seek to overcome the gastrointestinal (“GI”) ulcers and bleeding associated with NSAIDs. Antibe’s lead drug, otenaproxesul (ATB-346), is entering Phase III for osteoarthritis pain. Additional assets under development include a safer alternative to opioids for peri-operative pain, and a GI-safe alternative to low-dose aspirin. Learn more at antibethera.com.
Forward Looking Information
This news release includes certain forward-looking statements under applicable securities laws, which include, but are not limited to, statements about listing on a senior U.S. exchange, large market partnering and the expansion of strategic opportunities. 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”, “promises”, “move toward”, “look forward” and similar wording. 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 meet all of the quantitative and qualitative listing criteria to list on a US securities exchange; the Company’s ability to successfully arrange large market partnerships; the Company’s ability to capitalize on strategic opportunities; the Company’s ability to capture the full potential of its drug pipeline and platform, and the other risks identified in the Company’s public filings made in Canada. The Company 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.
Antibe Therapeutics Inc.
VP Investor Relations
Stern Investor Relations
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