Celyad Oncology SA

Welcome to the Celiad Oncology second half 2021 earnings conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After management's prepared remarks, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your telephone keypad. To withdraw your question, please press star, then two. Please note this event is being recorded. And I'd like to turn the conference over to Dan Ferry, Managing Director with LifeSci Advisors. Please go ahead, sir.

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 meeting applicable securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements may involve known and unknown risks and uncertainties, which may cause actual results financial condition, performance, or achievements of the company to differ 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 in its annual report on Form 20-F filed with the SEC on March 24, 2022, and subsequent filings and reports by the company. These forward-looking statements speak only as of the date 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 regulations. Let me now turn the call over to Filippo Petty, Chief Executive Officer of Cellular Oncology. Filippo, the floor is yours.

Thank you, Dan, and thank you, everyone, for joining us today as we report the financial results for 2021 and provide an operational update. Joining me from the management team is our Chief Scientific Officer, Dr. David Gillum, our Chief Medical Officer, Dr. Charles Morris, and our Chief Business Officer, Dr. Steven Rubino. We will start today's call with an operational and clinical update, an overview of the financials, and then discuss key milestones we expect to achieve over the next several months. After our prepared remarks, we ask the operator to open the line for your questions. Throughout the past year, we've continued to execute on a number of our strategies, including making steady progress with our novel SHRNA-enabled programs. Our lead SHRNA program, CIAD211, is currently in the Phase I Immunity I trial, where we are evaluating its tolerability and clinical activity following cyclophosphine and fludarabine chemotherapy in patients with relapsed refractory multiple myeloma. The latest data from this study, which was presented at the ASH annual meeting in December 2021, showed a good tolerability profile and evidence of a clinical activity. We're pleased with the progress made with this program to date. and we anticipate additional data to follow later this year. We've also introduced the first preclinical candidate for our armored CAR franchise, which we aptly named SHARC for its shRNA armored CAR-Ts. Regarding CIAT-203, this is our first preclinical shRNA-based allogeneic armored CAR-T candidate engineered to co-express IL-18 with the NKGTD CAR receptor. We are currently working on conducting IND-enabling studies And assuming those studies are successful, we anticipate submitting an IND application by the end of this year. While our SHRNA programs have continued to move forward, we unfortunately encountered a setback with our TIN-based CIAD 101 candidate. Earlier this month, we paused our phase one CIAD 101 slash 002 trial after two fatalities occurred in patients that are presented with similar pulmonary findings. The FDA subsequently placed the study on clinical hold, and with the safety of our patients as our first priority, we are focusing our efforts on investigations into the causes of these events. We hope to provide an update on the CIAD 101 program when additional information becomes available. The current setback with CIAD 101 should not overshadow the many achievements we accomplished over the past year, including bolstering our balance sheet in December 2021, with the announcement of a $32.5 million private placement by an affiliate of Fortress Investment Group. This investment ushers in a new era for cellular oncology as the infusion of growth capital will be used to fund the clinical development of our allogeneic CAR-T candidates to advance our pipeline of preclinical CAR-T candidates and fortify our robust intellectual property estate. Throughout the past 12 months, we've announced encouraging clinical data from our programs at major scientific conferences, which Charlie will discuss next. With that, I'll now turn the call over to Dr. Charlie Morris, our Chief Medical Officer, to provide you more details on our clinical programs. Charlie?