CTI BioPharma Corp.

Good afternoon. Thank you. Bye. Welcome to the CTI Biopharma's first quarter 2022 earnings call. During today's presentation, all parties will be in the 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, May 12, 2022. I'd now like to turn the conference over to Dr. Adam Craig, CEO and President of CTI Biopharma. Please go ahead.

Thank you, Victor, and welcome to this afternoon's conference call. Joining me today are David Kerski, Chief Financial Officer, Bruce Seeley, Chief Operating Officer, and Jim Fong, Chief Commercial Officer. Following formal remarks, the conference call will be open for questions. 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 type of statements identified as forward-looking in our 2021 annual report on Form 10-K that was filed on March 31, 2021, 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 and not guarantees a 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, market adoption of Vonjo, and the future success of our product launch. For further description of these and other risks and uncertainties that will 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 SEC. So the first quarter of 2022 was transformational for CTI as we worked towards becoming the market leader in the treatment of cytopenic myelofibrosis, following the recent FDA-accelerated approval of Vondro or Procritinib for the treatment of adults with myelofibrosis with a platelet count below 50 times 10 to 9 per liter. This approval was based on the Phase III PERSIST-II trial, a study that enrolled myelofibrosis patients with platelet counts less than or equal to 100 times 10 to 9 per liter, making it the only randomized control study specifically designed to recruit a cytopenic myelofibrosis population. That is, patients with thrombocytopenia and anemia. In the U.S., there are approximately 21,000 people with myelofibrosis. Two-thirds of these patients have cytopenia, resulting either from disease or commonly from the toxicity of other approved therapies. Severe thrombocytopenia, defined as a blood platelet count below 50 times 10 to the 9 per liter, occurs in one-third of the overall MF population and has a particularly poor prognosis with a median overall survival of just 15 months. On approval, our Vonjo cell team were fully trained on the Prout label and were able to commercially launch Vonjo within 10 days of FDA approval. The market has responded very well to the launch, primarily due to the fact that Vonjo is highly differentiated when compared to other therapies. We are extremely proud of our progress thus far, having exceeded our internal projections with 2.5 million in net product sales in just a few weeks. In addition, we were recently pleased to announce that Vonjo is now included as a recommend treatment in the latest National Comprehensive Cancer Network, or NCCN, clinical practice guidelines in oncology for myeloproliferative neoplasms, increasing the treatment options for patients. FONJO is now recommended within the guidelines as a frontline treatment for high-risk patients with myelofibrosis with platelet counts less than 50 times 10 to 9 per liter, and as a second-line treatment for lower- and high-risk patients with myelofibrosis and platelet counts equal to or greater than 50 times 10 to the 9 per liter. Fonjo is the only approved JAK inhibitor recommended by the NCCN for myelofibrosis patients regardless of platelet counts. I'll now pass the call over to Jim Fong, our Chief Commercial Officer. Thank you, Adam.

As Adam just mentioned, we are thrilled to report the $2.3 million in net product revenue for Fonjo generated from just 19 selling days. Impressive sales results reflect the strong demand due to the significant unmet need for cytobinic MF patients, and BonJo's differentiated clinical profile compared to existing MF treatments. It is important to note that we intentionally kept initial launch inventories low, and as a result, our specialty pharmacies and distributors have already reordered BonJo multiple times in March. Initial utilization of Bonja has been both as first-line and second-line therapy in patients with platelet counts less than 50,000, as well as spontaneously in patients with platelet counts above 50,000. While early adoption has been robust in the academic accounts, I'm particularly pleased to report that the uptake in the community setting has been higher than we expected, potentially driven by the level of dissatisfaction with the suboptimal therapy of low-dose ruxolitinib and the potential to optimally treat cytopenic patients with an effective full dose of Bonjo. As we move forward into the quarter, our MS target audience continues to show great excitement for Bonjo with significant growth in new patient starts, first-time prescribers, and high refill rates week over week. Looking forward, as we proceed with the execution of the commercial launch of Bonjo, we will remain focused on our three main launch objectives that are expected to build a strong foundation for success. First, we continue to build awareness among MF treaters as to the clinical significance and prevalence of cytopenic myelofibrosis, the specific challenges these patients face, and the limitations of existing therapies to adequately treat these patients. Second, we will continue driving adoption and utilization across our high potential prescribers and accounts. In response to the needs of our customers, we are investing in a mix of both in-person and virtual promotional resources to support our experienced field team, while also leveraging peer-to-peer programs, digital marketing, and medical conferences to ensure maximal HCP coverage and appropriate education. While COVID-19 still presents challenges for our field team, we have had higher than expected number of in-person meetings following our FDA approval. To this end, I am proud to inform you that our sales and marketing teams executed a highly successful Vangio national launch broadcast across 35 cities at the end of March that was attended by over 500 healthcare professionals, the majority participating in person. Third, we are focused on ensuring optimal patient access to Vangio. As previously reported, on approval, we immediately launched CTI Access, our comprehensive patient support program. TTI Access, staffed by highly skilled oncology case managers with deep experience in access and reimbursement, offers patients high-touch support throughout the reimbursement process. TTI Access will provide robust financial assistance program for eligible patients, including co-pay assistance, rapid start, and coverage interruption programs, and where appropriate, a program that will provide Bonjo at no cost to eligible patients who do not have insurance nor whose insurance does not cover Bongeo. During the first quarter, our patient services team has been able to minimize coverage denials and affordability issues and provide Bongeo bridge therapy for those patients waiting for coverage approval. Lastly, among the many new patients starts in March, none have required enrollment into our patient assistance program. In conclusion, I firmly believe Bongeo will continue to make a meaningful difference in the lives of patients with cytobinic myelofibrosis who have political accounts below 50,000 in the coming months and years ahead, and based on the feedback we have received from our customers, they believe this as well. I will now turn the call over to David to review our quarterly financials. David?