Incannex Healthcare (IXHL) Appoints Robert B. Clark to its Board

Incannex Healthcare Limited (Nasdaq: IXHL) is pleased to announce the appointment of experienced pharmaceutical executive Mr Robert B. Clark to the Board of Directors.

Mr Clark is a senior-level strategic regulatory affairs expert with over 38 years of US and Global regulatory experience, including >20 years with Pfizer Inc. and >10 years with Novo Nordisk A/S. He is an internationally recognized expert on US Food and Drug Administration (‘FDA’) and the European Medicines Agency (EMA) liaison interactions, US pharmaceutical advertising practices and regulatory aspects related to healthcare professionals and sales force activities.

Mr Clark is Vice President, US Regulatory Affairs for Novo Nordisk where he provides strategic leadership to a team of over 50 regulatory staff and scientists in the development of new medicines. He advises the global executive team on matters related to drug development programs, FDA liaison strategies, managing FDA-related compliance issues, and monitoring emerging US regulatory trends and opportunities. He and his team manage all interactions with FDA on behalf of Novo Nordisk and have secured FDA approvals for twelve (12) significant new drugs for the company since his tenure began in 2012.

Prior to joining Nova Nordisk, Mr Clark was Vice President of Worldwide Regulatory Strategy and US Regulatory Affairs at Pfizer, leading a team of up to 150 regional regulatory professionals supporting the drug development continuum. During his time at Pfizer, he led or supported FDA approval of many new medicines and represented Pfizer at critical interactions with FDA, and other global health authorities, including key project milestone meetings.

Mr Clark has senior level experience in managing regulatory aspects of large-scale pharmaceutical acquisitions, significant compliance matters and business development due diligence activities. He also has documented success with FDA accelerated approval programs including Fast-Track, Orphan Drug, Breakthrough Therapy Designations, and Priority Reviews, which are areas of interest for Incannex management due to the nature of its drug candidate mix.

“Bob is amongst the best credentialed regulatory affairs experts in the world, and we’re delighted that he has joined our board of directors because it is a strong vote of confidence in our drug candidates and development strategy”, said Mr Joel Latham, CEO and Managing Director of Incannex. “He brings to Incannex deep knowledge of the US regulatory environment and decades of experience at the highest level of large pharmaceutical organisations. His experience will be invaluable to us now that our interactions with FDA have become more frequent whilst we pursue our mission to bring cannabinoid and psychedelic pharmacological solutions to patients with unmet medical needs”.

Non-executive Director, Mr Robert B. Clark said, “I look forward to working with the Board and the management team, and I am excited about the broad Incannex portfolio of products to treat patients who have few or no other available treatments. Cannabinoid and psychedelic pharmacotherapies represent a growing area of research and hold the potential to treat various conditions for which effective options are limited”.

Mr Clark holds a Master's in Science in Pharmacology from the New York Medical College and formally commences his directorship on August 17, 2022.

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