180 Life Sciences CEO says priorities continue to be clinical programs

The company said, "As we come to the end of 2022, I am pleased to provide an update for our shareholders. In keeping with good corporate practice and US Securities and Exchange Commission regulations, we have refrained from answering individual queries from shareholders until we were able to provide information to all shareholders at the same time. Our priorities continue to be our clinical programs, repurposing anti-Tumor Necrosis Factor drugs for treating Dupuytren’s disease, frozen shoulder and post-operative delirium. The Dupuytren’s contracture trial phase 2B trial, led by Prof Nanchahal, the results of which we have previously announced, exceeded our expectations. It also showed that the treatment is likely to be cost-effective. Now, after obtaining scientific advice from the UK Medicines and Healthcare products Regulatory Agency, the UK equivalent of the US Food and Drug Administration, and after discussions with our regulatory consultants in the United States and United Kingdom, we made the decision to begin preparing all the material necessary to seek marketing authorization in the UK. Based on the guidance received from our regulatory consultants on the time required to prepare the marketing authorization application, we currently plan on filing the application in mid-2023. In seeking a marketing authorization, we plan to engage a specialized consultant, Dr. Keith Watson, who spent nearly five years with the MHRA as a reviewer of biologics product applications, later serving as Director of Global Regulatory Affairs, Biologics Strategic Development Group at AbbVie, and more recently Vice President of Regulatory Affairs for Celltrion Inc. He now manages his own regulatory consulting practice….A published study from the Netherlands showed that increase in nodule size correlates with finger flexion deformity and we reason that a reduction in nodule size would conversely mean that fingers are less likely to contract. As previously disclosed, the MHRA reviewed the primary and secondary endpoints in the phase 2b trial and the data provided by the Company and noted that it has not been shown that reducing nodule size via treatment would lead to improvements in terms of Dupuytren’s disease progression. We plan to continue to collect all available data to address the point made by the MHRA. In addition, we may conduct a follow-on study to address the requirements of the MHRA, the EU, and the US FDA. We expect Dr. Watson will provide us advice regarding the best path forward assuming we receive Conditional Marketing Authorization. With the recent financing complete, the Company is proceeding with the preparation of the necessary CMA application documents. It is a very substantial, but worthwhile task…Enrollment to the trial of anti-TNF for early-stage frozen shoulder is slower than anticipated in the UK as patients typically present to physical therapists and the processes are subject to delays. In the USA, all such patients are seen by orthopedic physicians, who are relatively easy to access. The trial team has implemented several strategies to improve recruitment and we hope that these will be effective. Preparation for the trial of anti-TNF to prevent the development of postoperative delirium remains on track and we anticipate that the first patient will be recruited in the first half of 2023…Our HMGB1 program continues to advance slowly. The molecular dynamics for the binding of this molecule are extremely complex and potentially need more extensive research in order to identify a lead candidate. The synthetic cannabinoid program is also moving along, albeit slower than expected, with an emphasis on more effective formulations to ensure that the cannabinoids are much more orally available, as they are currently very poorly absorbed. We are continuing with our research in this field towards the development of a treatment for chronic pain. Assuming that the oral formulation research efforts are successful, we may initiate early trials in patients suffering from chronic pain, perhaps in early 2024. As most of you know, we remain in some ongoing litigation and at this point we have no further update on such matters other than what has been reported in extensive detail in our most recent Quarterly Report on Form 10-Q."