11/2/2023

speaker
Operator
Conference Call Operator

Good morning and welcome to SelectR Biosciences' third quarter 2023 update. Today's conference is being recorded. At this time, I would like to turn the conference over to Monique Kos of LifeSci Advisors.

speaker
Monique Kos
LifeSci Advisors

Please go ahead. Thank you, Operator, and welcome everyone. This morning, SelectR issued a press release providing a corporate update. You may access that release on the company's website under the Investors tab. With us today are Jim Caruso, President and CEO of Selectar, Chad Colleen, Chief Financial Officer, Jared Longcourt, Chief Operating Officer, Shane Lee, Chief Commercial Officer, and Andrei Shustov, VP Medical. Following our prepared remarks, we will open the call for a Q&A session. Before we begin, I would like to remind everyone that statements made during this call, including the Q&A session, relating to Selectar's expected future performance, future business prospects, or future events or plans are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Although the company believes that the expectations reflected in such forward-looking statements are based upon reasonable assumptions, Actual outcomes and results are subject to risks and uncertainties that could differ materially from those forecasts due to the impact of many factors beyond the control of Selectar. The company assumes no obligation to update or supplement any forward-looking statements, whether as a result of new information, future events, or otherwise. Participants are directed to the cautionary notes set forth in today's press release, as well as the risk factors set forth in SelectR's annual report filed with the SEC for factors that could cause actual results to differ materially from those anticipated in the forward-looking statements. Now, I would like to turn the call over to Jim Caruso, President and Chief Executive Officer of SelectR. Jim?

speaker
Jim Caruso
President and Chief Executive Officer, SelectR Biosciences

Thank you, Monique, and good morning, everyone. It is my pleasure to welcome you to our conference call highlighted by this morning's announcement that top-line data from our Clover-WAM pivotal study in Waldenstrom's macroglobulemia is planned to be announced the week of January 8, 2024, during the J.P. Morgan Healthcare Conference. We continue to collect and evaluate patient data from our pivotal trials. and view this announcement as a potentially transformational event for the company. And as such, merits increased awareness and an attentive audience, which the J.P. Morgan Healthcare Conference will certainly provide. As previously discussed, our operations team has been engaged in the development of our NDA filing, which we plan to submit in the March or Q2 2024 time frame. Assuming a priority review based on Ipofacin's fast-track designation, a six-month FDA review targets the potential approval of Ipofacin in Q4 2024. Later in this call, Shane Leah will provide a summary of our commercial launch activities in preparation for our planned Q4 2024 U.S. launch. While the company priority remains focused on the FDA approval and commercial launch of ipofasine for WM, in parallel, we continue to evaluate ipofasine for relapsed, refractory, primary central nervous system lymphoma, and salvage therapy multiple myeloma in our ongoing phase 2A clinical study. In addition, we look forward to announcing the first planned enrolled patient in our phase 1B in pediatric high-grade glioma. On the financial front, we recently completed a successful pipe led by Rosalind Advisors with participation from an excellent group of new and existing institutional investors, including AIGH Capital, ADAR1, Second Line, Nantahala Capital, and AUGC, among others. The pipe is expected to provide more than $100 million in funding to fully support our strategic plan into mid-2025, including hypophysine I-131 development and commercialization, our research and development plans across the entirety of our platform, and supports our transition to a commercial biotech company. Over the past quarter, we added two key executives to our commercial leadership team to prepare for the potential marketing of Hypophycine. We further strengthened our global intellectual property portfolio with the addition of four new patents and secured prime designation in Europe for Hypophycine and relapsed refractory WM. We view this designation as a significant achievement Prime designation is granted to less than one in four applicants and is designed to expedite the achievement of marketing authorization in the EU. The remainder of our call today will consist of a brief financial update by Chad, a commercial summary from Shane, and a WM market landscape review by Andre. I will close with a brief WM specific summary and then we will then open the call for Q&A. I'll now hand it over to Chad for a brief review of our financials. Chad?

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