Celyad Oncology SA

Greetings and welcome to the Cellulite Oncology first half 2022 financial results. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. I would now turn the conference over to your host, Sarah Zelkovic, Director of Communications and Investor Relations for Cellulite Oncology. Thank you. You may begin.

Thank you all for joining us today. Before we begin, I would like to remind everyone that today's event may contain forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may involve known and unknown risks and insurgencies, which might cause actual results, financial conditions, performance, or achievements of the company to differ materially materially from those expressed or implied by such forward-looking statements. A list and description of these risks, uncertainties, and other risks can be found in the company's U.S. Securities and Exchange Commission filings and reports, including an annual report on 20F filed with the FCC on March 24, 2022, and subsequent filings and reports by the company. These forward-looking statements speak only as of the date of the of this call and the company's actual results may differ materially from those expressed or implied by these forward-looking statements. The company expressly disclaims any obligation to update any such forward-looking statements made on this call to reflect any change in its expectations with regard thereto or any change in events, conditions, or circumstances on which any such statement is based unless required by law or regulation. Let me now turn the call over to Michelle Lussier, Interim Chief Executive Officer of Cellular Oncology. Michel, the floor is yours.

Thank you, Sarah. And thank you, everyone, for joining us today for our financial results and operational results update call for the first half of 2022. Joining me today from the executive committee team is our chief medical officer, Dr. Charlie Morris, and our vice president of finance and administration, David George. We will start today with an operational and clinical update. followed by an overview of the financials and outline the expected key milestones of the company over the next several months. We will then open the line for your questions. So there have been many changes to the company in terms of the clinical candidates and leadership in the first half of the year. Importantly, we say goodbye to our previous CEO, Filippo Petti, who stepped down in June to seek other opportunities I must say we've had a very smooth transition over the past month, and I've taken over as interim CEO. And I want to thank dearly Filippo for his broad contributions to cellulite oncology over the past years. We have begun the search for a new CEO and are targeting a European-based person to helm our headquarters in Belgium. We're also happy to announce that the board of directors, as named Hilda Wendel's, Hilda has been on our board for a number of years and will now be the chair of our board directors because I stepped down as chairman to take the CEO helm. She is a prominent board member in the European biotech industry and we look forward to continuing our work under her guidance. In addition, Dr. David Gilham, our former chief scientific officer, also resigned to seek other opportunities David has been with the company almost eight years, and he felt this timing was a natural transition as the new head of R&D, Dr. Eitan Bremen, takes over to continue our work on our shRNA platform and discovery CAR-T programs. I also thank David for his significant reshaping of our R&D efforts as we shifted our approach in the field of CAR-T towards allogenic therapies underpinning biomechanics. underpinned by SHRNA technology. So while we've had many changes in the past few months, we look forward to focusing our efforts on four major pillars of the business to maximize all potential value drivers of the company in the coming months and years. Our first pillar is our research and development efforts. A main focus will be on research that will utilize our SHARC or SHRNA-armored CAR-T franchise. We introduced this platform last year, and although we did make the decision in April to stop development of CIAD2 or 3, our allogenic, SHRNA-based IL-10-armored NKG2D CAR-T candidates, I want to note that we're making promising progress in multiple discovery programs focused on the co-expression of IL-18, including the exploration of backup allogeneic NKG2D receptor CAR T candidates, which leverage this platform. Currently, our armored CAR Ts are engineered to release IL-18, providing the opportunity to drive increased potency of our cell therapy by impacting the CAR T and the local tumor microenvironment, especially important for the treatment of solid tumors. We think that this is an ideal platform for developing unique CAR T products for difficult-to-treat diseases and could overcome the challenges related to treating solid tumors. Moving to our pipeline, our next pillar, we've had challenges and opportunities related to our allogenic CAR T candidates this year and are happy to announce that our trials are getting back on track where they should be, At the end of July, we received notification from the FDA that they are lifting the clinical hold put on our investigational candidate, CIAD 101. This is a significant milestone for the company, and we're very excited at the potential development of CIAD 101 and other product candidates using our TIM technology. Patient safety continues to be our biggest priority, and we're proud to have safely tested many people with cancer using our TIM technology and NKG2D targeting CARs in clinical trials. I'd like to take this time to thank the team for their hard work and dedication to providing timely responses to the FDA in order to get this hold lifted as quickly as possible. In addition, enrollment for the dose escalation portion of Immuni-C trial with CI-211 has been steady with one patient enrolled per month, and we're excited about the data we're generating and will share this year. Immuni-C1 has been an invaluable way for us to showcase the benefits of our proprietary shRNA technology in a real-world clinical setting. We truly believe that this non-gene editing technology offers great opportunity to drive differentiated candidates for both solid tumors and hematological malignancies. The third pillar and a value driver that has been underutilized so far in the company relates to our unique intellectual property within the CAR-T landscape. Our U.S. patents around allogeneic CAR-T therapy and NKG2B 2D-based technologies provides an avenue for the company to develop its own programs and to partner with outside parties around the licensing of these patents. We are planning a renewed strategic focus to leverage additional potential licenses. And finally, the last pillar of a renewed strategy, as we see a significant opportunity, is for in-house manufacturing expertise. This facility has been a great investment for us over the past decade, and we are currently evaluating opportunities on how we can further leverage this core asset within the overall strategy of our business. So let me stop here and turn the call over to Dr. Charlie Morris, our Chief Medical Officer, to provide more detail. Charlie?