CTI BioPharma Corp.

Good morning and welcome to the CTI BioPharma fourth quarter and year end 2022 financial results and corporate update conference call. As a reminder, this conference call is being recorded. I would now like to introduce your host, Rumi Bernada, CTI Investor Relations. Please go ahead.

Good morning, everyone, and thank you for joining us on the call today. Before we 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 harbor provision of the Private Securities Litigation Reform Act of 1995, including, but not limited to, the types of statements identified as forward-looking in our most recent annual report on Form 10-K and our subsequent periodic reports filed with the SEC which are available on our website in the investor section. Such forward-looking statements, which are indicated by terms such as expect, intend, and seek, represent our views as of the date of this call, 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. These statements include our expectations regarding cash runway, timing to profitability, market adoption of BonJo, and the future success of our product launch. In addition, any forward-looking statements represent our views as of today and should not be relied upon as representing our views as of any subsequent date. While we may elect to update these forward-looking statements in the future, we specifically disclaim any intent to do so even if our views change. For a further description of these and other risks and uncertainties that may 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 periodic reports filed with the FCC. On today's call, we have Dr. Adam Craig, our President Chief Executive Officer and Interim Chief Medical Officer. David Kerski, our Chief Financial Officer, and Jim Fong, our Chief Commercial Officer. After our formal remarks, we will open the call for your questions. I would now like to turn the call over to Adam.

Thank you, Romy, and good morning. We appreciate everyone joining us earlier than planned so that we can provide a timely update following the recent release of portfolio revenue by our royalty financing partners. I want to start the call today by reflecting on the achievements we've made over the past year as we've transformed from a research and development organization to a fully integrated biopharma with a strong commercial presence. In the first quarter of last year, we received accelerated approval from the FDA for Vonjo Procritinib for the treatment of adults with myelofibrosis with a platelet count below 50 times 10 to the 9 per liter. This approval launched our commercialization efforts, and we are extremely pleased with our progress to date. We generated $54 million in net sales in just the first nine months of commercialization, exceeding our internal year-end revenue goal, and in the process treated over 1,000 patients with Vonjo in 2022, a meaningful achievement for a rare disease such as MF. Jim Fong will elaborate on our commercial success in just a moment, but I'd like to spend a little time talking about the new data presented in December at the ASH annual meeting in New Orleans by Dr. Stephen Oh of Washington University. In his oral presentation, it was shown that procritinib is a potent actin-A receptor type 1, or ACVR1 inhibitor, that has potential to provide a significant anemia benefit in patients with cytopenic myelofibrosis. ACVR1 mediates hepcidin production, and its inhibition is thought to lead to improvements in transfusion independence and anemia in myelofibrosis patients. Anemia is common in MF, both at diagnosis and during therapy, and it's a poor prognostic factor. Almost all MF patients will develop anemia over the course of their disease due to disease progression and or drug toxicity from other approved JAK inhibitors. Dr. O's presentation highlighted several key findings related to Procritinib. In vitro data demonstrated that Procritinib inhibits ACVR1 at four times greater potency compared to Momolotinib with 24-hour inhibition of the targets. It was shown in vitro to reduce hepcidin levels. The clinical data demonstrated that treatment with Vonjo at the approved dose of 200 milligrams twice daily led to improvements in transfusion independence and anemia when compared to best available therapy, which included ruxolitinib. In invaluable patients treated on the phase three PASSIST-2 study. Over the last year, we have worked hard to establish the Vonjo franchise in the commercial space. To this end, we have filed for a patent term extension for our main composition of matter patent that, if granted, would extend this term by five years with an expected expiration date of 2034. And last month, Vonjo was granted seven years of orphan drug exclusivity by the FDA for our label indication that began in February 2022. As we enter our second year of commercialization for Vonjo, we are focused on generating quarter-over-quarter product sales while providing the best care to patients with cytopenic myelofibrosis. With that, I'll hand the call over to Jim.