Athenex, Inc.

Good day, ladies and gentlemen, and welcome to the fourth quarter 2021 Athenax Earnings Conference call. At this time, all participants are in a listen-only mode. A brief 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 like to turn the conference over to Kylie Doherty, Director of Investor Relations. You may begin.

Good afternoon, and thank you for joining our conference call. Today, we will provide an update on a Phoenix's business, as well as a review of financial results for the fourth quarter and full year 2021. The news release detailing the results crossed the wire earlier today and is available on the company's website. A replay of this call will also be archived on the company website. During the conference call, the company will make projections or forward-looking statements regarding future events. including statements about financial, business, and clinical milestones anticipated in fiscal year 2022 and beyond. We encourage you to review the company's past and future filings with the SEC, which identify specific factors that may cause the actual results or events to differ materially from those described in the forward-looking statement. You can find our SEC filings in the EDGAR database at www.sec.gov. or in the Investor Relations section of our website at www.athenix.com. Today we are joined by Dr. Johnson Lau, Chief Executive Officer, Dr. Dan Lang, President of Athenix Cell Therapy, Dr. Kurt Gunter, Chief Medical Officer of Cell Therapy, Mr. Jeff Yorden, Chief Operating Officer, and Mr. Joe Anoni, Chief Financial Officer. The management team will be available to answer questions after the prepared remarks. I will now turn the call over to Johnson for introductory comments.

Thank you, Katie. And thank you, everyone, for joining our conference call this afternoon. I'm excited to walk you through the implications of the announcement we made this morning regarding the strategic pivot of the company and several financial initiatives we have already begun implementing. We made this decision to focus on our cell therapy platform because we believe it has the best-in-class potential and therefore deserves to be the highest priority for our experienced leadership team. We are also working on a strengthened balance sheet that provides a cash runway to allow us to meet our objectives to increase shareholder value and bring innovative treatments to cancer patients. I want to highlight the three key elements of this plan. First, we are refocusing our therapeutic development efforts on our cell therapy programs. Second, we will discontinue most of our R&D initiatives around oral discovery. Third, we are strengthening our balance sheet by monetizing non-core assets. We are also implementing significant cost-saving programs to reprioritize the company to focus on cell therapy. Our management team and board conducted an extensive review of our operations and pipeline. And it's clear to us that the best opportunity to create significant long-term value is by focusing on cell therapy. We see our cell therapy technology as differentiated and believe it has the potential to be highly competitive and potentially disruptive to the current cell therapy landscape. Specifically, we think it can address some of the challenges facing the existing CAR-T treatments, and the early clinical data from our candidates have been very promising. Dr. Stan Lang and Kurt Gunther will provide more details in a few minutes on our strategic plan to build upon our foundational self-therapy programs to create a leading franchise. The oil scuffling programs, served as the main focus of APNIC's clinical development efforts up until 2021. We announced previously that we would not be pursuing the metastatic breast cancer indication in the U.S. after receiving a complete response letter from U.S. FDA. We are now taking this a further step and have decided to discontinue other oral programs in combination with Ensecadar. There are only two ongoing oral pachytextile trials that could potentially unlock value that will both continue. It says validity to limited investment required by Phoenix. The first of these is the I-SPY-2 trial, which has an expected window in the second half of 2022. We call that the quantum leap. Healthcare Collaborative has been using our drug in two of its three arms in combination with Dostarumab plus or minus carboplatin in breast cancer patients in the neoadjuvant setting. This is a randomized phase two trial that could advance into phase three and beyond if results are encouraging. And it's an area of value that could be unlocked. This program requires a minimum future resources for Mayfinex, but we hope that this data readout could drive additional value for our shareholders. We are also pleased to announce that we have initiated the expansion portion of the Phase 1-2 clinical trial of Oropacetaxel in combination with Pembrolizumab in patients with non-small cell lung cancer. This comes after reporting highly encouraging data of four partial responders and four stable diseases in eight evaluable patients at ESMO last fall. We will continue to monitor the progress of both these studies and will look for opportunities to extract further value from this asset through potential partnerships or other means. As a reminder, The UK Medicines and Healthcare Products Regulatory Agency validated our market authorization application for oral pachytexel for the treatment of advanced breast cancer. And we look forward to updating you on the regulatory process in the coming months. Moving on to our balance sheet. Last quarter, we said that we would pursue various initiatives to unlock long-term value, and we have so far raised a total of $40 million in the first quarter. This process will be used towards debt pay down as well as providing operating cash to support our R&D programs in self-therapy. We recently completed the sale of our manufacturing facility in Dunkirk, New York to Immunobar on February 14. We are pleased with how quickly we were able to close this transaction. Having entered discussion with Immunobar late in 2021 and announced the agreement in early January this year, Mr. Jeff Yoden will provide more details on the implications of this sale in a few minutes. There are several components of our business unrelated to cell therapy that we now consider non-core. We are in the process of carrying out actions that will unlock value from these assets, as we did with Dunkirk. We look forward to updating you on those activities in the coming months. A critical component in the organizational changes within the Phoenix is an aggressive cost-cut dating program. which unfortunately will put a reduction in headcount. We have also identified additional means of cutting costs and implementation of this plan is expected to reduce operating expenses by over 50%. All together, with divesting non-core assets and cost reduction programs, we plan to extend cash runway to beyond 18 months We believe the combination of initiatives I have outlined has the potential to unlock value for our shareholders. Finally, Mr. Joe Annone, who was recently appointed our new CFO, is joining us on the call today. Joe brings over 20 years of experience, having worked in big four advisory, investment banking, and private equity. He has expertise in developing and implementing strategic changes within complex environments, which will be extremely valuable to us as we prioritize our programs. I'll now turn the call over to Dr. Dan Lang to discuss our cell therapy programs.