Caladrius Biosciences, Inc.

Welcome to the Calidaris Biosciences Second Quarter 2022 Financial Results and Business Update Conference Call. Currently, all participants are in listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ask a question at that time, please press star 1-1 on your telephone. You will then hear an automated message advising that your hand is raised. As a reminder, this call is being recorded today, Thursday, August 4th, 2022. I will now turn the call over to John Mendito, Vice President of Investor Relations and Corporate Communications at Collegius. Please go ahead, sir.

Thank you, operator, and good afternoon, everyone. Welcome to Collegius' second quarter 2022 conference call to discuss our financial results and provide a business update. Joining me today from our management team are Dr. David Mazzo, President and Chief Executive Officer, Dr. Kristen Buck, Executive Vice President of Research and Development and Chief Medical Officer, and James Nisko, Vice President of Finance and Treasury. Shortly before this call, we issued a press release announcing our second quarter 2022 financial results, which is available under the Investors and News section of the company website, along with a webcast replay of this call. If you have not received this news release or you'd like to be added to the company's email distribution list, please email me at jmendito at colladurus.com. Before we begin, I will remind you that comments made by management during this conference call will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Colladurus. I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, which form 10Q, 8K, and 10K, which identify specific risk factors that may cause actual results or events to differ materially from those described in the forward-looking statements. Furthermore, the content of this conference call contains time-sensitive information that is accurate only as to the date of this live broadcast, Thursday, August 4th, 2022. Gladys Biosciences undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call. With that, I will now turn the call over to Dr. Mazza. Dave?

Thank you, John, and good afternoon, everyone. Thank you for once again joining us today as we provide an overview of recent business highlights and discuss our second quarter 2022 financial results. I can say to you with much enthusiasm and certainty that 2022 is proving to be an outstanding year of progress for Colladrius as the proposed merger with SEND Therapeutics remains on track to close in the third quarter of this year, subject to approval by our stockholders. This transaction will be transformational for Colladrius, creating, upon closing, a financially sound NASDAQ-listed company with a diverse product development pipeline, strong existing partnership, and the potential for future attractive partnerships. The merged company will operate under the name Lasada Therapeutics, Lasada for short, and will focus on maximally exploiting the full potential of SEND's SEND-R platform technology in a range of solid tumor indications while progressing Caladrius' current CD34 positive technology-based product candidates to their next development milestone. SEND-1, the lead product candidate from the SEND-R platform, has the potential to be combined with myriad chemo and immunotherapeutic agents and could become an integral part of a revised standard of care therapy for many difficult to treat cancers. Coincident with the announcement of the signing of the definitive merger agreement back in April, we also announced that we had made a $10 million investment in SEND in order to maintain the momentum of development of SEND 1 and to allow for immediate collaboration between the companies. Since then, a number of achievements have been announced regarding SEND 1. For example, in June, It was announced that the first patient had been treated in the Phase 2b ASCEND study of SEND1 in combination with gemcitabine and nabpaclitaxel for the treatment of first-line metastatic pancreatic ductal adenocarcinoma, MPDAC for short. This 125-patient study is a double-blind, randomized, placebo-controlled clinical trial being conducted at up to 40 sites in Australia and New Zealand, led by the Australasian Gastrointestinal Cancer Trials Group in collaboration with the National Health and Medical Research Council's Clinical Trial Center at the University of Sydney. Additionally, groundbreaking data was recently published in the Lancet Gastroenterology and Hepatology Journal from the Phase 1B study of SEND1 in combination with gemcitabine and nabpaclitaxel for the treatment of first-line MPDAC. The results reinforce our belief that SEND1 could become a transformative new medicine for the treatment of pancreatic cancer and other difficult-to-treat solid tumors. Imminently, we expect to announce a collaboration with a major pharmaceutical company regarding SEND1, as well as advancement of our plans to initiate a registration-worthy study of SEND1 in MPDAC next year, along with a basket trial exploring the advantages of combining SEND1 with current standard of care in a variety of other solid tumor types. With that, I will now turn the call over to James Nisko, our VP of Finance and Treasury, to review and provide commentary on our second quarter 2022 financial results. James?