CTI BioPharma Corp.

Good afternoon. Thank you for standing by and welcome to CDI Biopharma's second quarter 2021 earnings call. During today's presentation, all parties will be in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone. This conference is being recorded today, August 5, 2021. I'd now like to turn the conference over to Dr. Adam Craig, CEO and President of TBI Biopharma. Please go ahead.

Thank you, Laurie, and welcome to this afternoon's conference call. Joining me today are David Kersky, Chief Financial Officer, and Bruce Seeley, Chief Operating Officer. Following formal remarks, the conference call will be open for questions. Before I begin, please note that during this call, we will be making forward-looking statements based on current expectations. Such statements are within the meaning of the safe harbour provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the types of statements identified as forward-looking statements in our 2020 Annual Report on Form 10-K that was filed March 17, 2021, and our subsequent periodic reports filed with the SEC which are available on our website in the investor section. Such forward-looking statements represent our views only as of the date of this call and are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward-looking statements, including many that are beyond our control. For a further description of the risks and uncertainties that would cause actual results to differ materially from those expressed in the forward-looking statements, as well as risks related to our business, please see our peer audit reports filed with the SEC. This quarter, we have continued to advance Procritinib towards a potential US approval and commercial launch this year. The FDA's acceptance with priority review of our NDA submission for the use of pacritinib in myelofibrosis patients with thrombocytopenia underscores the unmet medical need in this area. Our PDUFA target action date is November 30, 2021, and the FDA is not currently planning to hold an advisory committee meeting to discuss the application. As a reminder, the NDA was accepted based on data from Phase III, Persyst-2, and Persyst-1, and the Phase II to PAC-203 clinical trials, with a focus on the severely thrombocytopenic patients, that is, those with platelet counts less than 50 times 10 to the 9 per liter. Patients enrolled in these studies with severe thrombocytopenia and patients receiving pacritinib 200 milligrams twice a day were the focus of the NDA and included both frontline treatment naive patients and patients with prior exposure to JAK2 inhibitors. One-third of the existing myelofibrosis patient population have severe thrombocytopenia or approximately 7,000 patients. A population with suboptimal and limited treatment options and an urgent need for new therapies. To address this need, Our team has been working diligently on pre-commercialization activities, including market access, distribution of supply chain, disease education, and third force deployment. We are eager to commercially launch Procritinib immediately upon approval from the FDA, and given our application's priority review status, we are prepared to launch on the PDUFA date or earlier. In preparation for an early launch, we have completed the hiring of our third force leadership team and started to recruit our key account managers who will be our sales force. Moving on from myelofibrosis, last year we launched a study for creatinine in severe COVID-19 patients in response to the pandemic. This study prevent is a randomized, double-blind, placebo-controlled, multi-center Phase III clinical trial comparing the use of pacritinib plus standard of care versus placebo plus standard of care in hospitalized patients with severe COVID-19. The primary endpoint of the trial will assess the proportion of patients who progress to invasive mechanical ventilation and or extracorporeal membrane oxygenation or die by day 28. We continue to expect to report on the outcome of the interim analysis from this trial during this quarter. Finally, as we have previously discussed, we are investigating the use of Procritinib in the prevention of acute graft-versus-host disease, or GVHD. The investigators sponsored Phase II component of the ongoing Phase I-II study, investigating the addition of Procritinib to the standard prophylaxis of serolimus and low-dose tacrolimus in the treatment of GVHD continues to enroll. And we remain on track to provide an update on the progress of the phase two trial and any potential regulatory interactions around this indication later in the year. As a reminder, the American Society Hematology meeting in December 2020 data was presented from this study. that showed adding procritinib to the standard prophylaxis regime resulted in significant reduction in the expected acute graft-versus-host rates in patients within the first 100 days of therapy as compared to historical data without compromising transplantation outcomes and without any new safety concerns. I will now turn the call over to David to review our quarterly financials. David. Thank you, Adam.

As of June 30, 2021, cash and cash equivalents and short-term investments totaled $71.9 million as compared to $52.5 million as of December 31, 2020. Operating loss was $19.5 million and $10 million for the three months ended June 30, 2021 and 2020, respectively. No revenues were recognized for the three months ended June 30th, 2021 or for the three months ended December 31, 2020. Net loss for the three months ended June 30, 2021 was $19.7 million or 21 cents for basic and diluted loss per share as compared to a net loss of 14 million or 19 cents for basic and diluted loss per share for the same period in 2020. So with that, I'll hand it back to you, Adam.