CTI BioPharma Corp.

Hello, and welcome to the CTAO Biopharma Corporation 2Q22 earnings call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on your touch-tone phone. To withdraw your question, please press star, then two. Please note, today's event is being recorded today August 8th, 2022. And now I'll turn the conference over to Dr. Adam Craig, CEO and President of CTI Varma. Please go ahead.

Thank you, Keith, and welcome to this afternoon's conference call. Joining me today, 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 harbour 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 2021 annual report on Form 10-K that was filed on March 31, 2022, 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 that differ materially from those anticipated by the forward-looking statements, including many that are beyond our control. These statements include our expectations regarding cash runways, the market adoption of Vonjo, and the future success of our product launch. For a further description of these and other risk factors 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 SEC. In February of this year, our lead product Vonjo or Procritinib was FDA approved for the treatment of adults with myelofibrosis with a platelet count below 50 times 10 to 9 per litre. In the United States, of the approximate 21,000 patients with myelofibrosis, two-thirds have cytopenias, that is thrombocytopenia and or anemia, resulting from either disease progression or commonly from the toxicities of other approved therapies such as ruxolitinib. Severe thrombocytopenia, defined as a blood platelet count below 50 times 10 to 9 per litre, occurs in one-third of the overall MF population and has a particularly poor prognosis. In the second quarter of 2022, we continue to make substantial progress with the commercial launch of Vonjo in the United States. Today, we are delighted to report $12.3 million in net product revenue for the second quarter, driven by significant growth in Vonjo awareness among healthcare providers in both the community and academic settings, and an overall share of voice that exceeds that of our competitors. CTI continues to produce new data from our Procritinib program, reinforcing Von Joe's clinical value as a safe, simple, and effective therapy in cytopenic MF. At ASCO and EHA earlier this year, our scientific presentations highlighted Von Joe's place as a product that is differentiated from older JAK inhibitors. Our risk-adjusted analysis showed that the safety profile percritinib, 200 mg twice a day, was comparable to best available therapy, including ruxolitinib, and that percritinib 200 mg twice a day could be given as a full dose for patients with myelofibrosis, including those with severe thrombocytopenia. Additionally, full dose percritinib achieved high response rate and a similar manageable safety profile compared to the lower dose ruxolitinib, in patients with myelofibrosis who have moderate or severe thrombocytopenia. Looking ahead, starting this fall, we expect to share new data at international medical meetings that demonstrate procritinib's activity as a potent ACVR1 ALK2 inhibitor, as well as data on procritinib's important anemia benefit in myelofibrosis. Inhibition of ACBR1, which mediates hepcidin production, has been postulated as a mechanism for the improvement of anemia in MF. Finally, I'm pleased to announce that we have filed the patent term extension application for our U.S. composition of MATA pattern 8153632 with a requested five years of extension, which, if granted, would extend the expiration of this orange book listed patent from January 29 to January 2034. I'll now turn the call over to our Chief Commercial Officer, Jim Fong, to highlight our Vonjo launch achievements. Jim.

Thank you, Adam. As Adam just discussed, we are delighted to announce $12.3 million in net product revenue for Vonjo this quarter. This impressive start to our launch is a direct reflection of our commercial team's execution as well as the demand that exists among MF patients and their healthcare providers, that is, HCPs, who are in need of a safe, simple, and effective treatment option, that is, Vonjo. As previously mentioned, our experienced field team has been focusing on delivering against our three core Vonjo launch objectives. One, build Vonjo awareness among myelohyprosis HCPs. Two, drive adoption and utilization within our top accounts and high potential prescribers. And three, ensure optimal patient access via securing effective payer coverage as well as our patient support services called CTI access. Regarding awareness, we are pleased that our promotional efforts and activities are resulting in significant growth in bondual awareness among our target ACP audiences in both the community and academic settings with higher than expected Bonjo product awareness after just a few months following launch. Our sales results also indicate we are making significant headway with HCP adoption and utilization. We believe that this stems from our team's commitment to comprehensively educating the HCPs through their sales call activities, in-service meetings, and implementation of numerous peer-to-peer educational initiatives that help identify appropriate Bon Jovi patients. Our peer-to-peer educational programs have been very well received, as evidenced by the high number of attendees, the vast majority of which are in person, illustrating that HCPs are very interested in myelofibrosis and the value proposition that Bon Jovi offers. In addition, I am pleased to report that recent market research conducted at the end of May shows that Bonjo's promotional share of voice has already surpassed that of both ruxolitinib and fudratinib among high MF treaters. Our commercial execution is resulting in continued strong growth in new prescriptions and new prescribers in both academic and community settings. we are seeing early signals of strong refills occurring and few early discontinuations due to adverse events. We believe the overall adoption is indicative of the unmet need in the marketplace, including dissatisfaction with low-dose ruxolitinib and the potential to optimally treat patients with a full dose of Bonjo safely and effectively. Our research indicates ATPs have prescribed Bonjo as a first- and second-line therapy in myelofibrosis patients. A catalyst for this utilization can be attributed to the latest NPN National Comprehensive Cancer Network or NCCN guidelines. As we have previously highlighted, Vonju is the only approved JAK inhibitor recommended by NCCN regardless of platelet count. This includes as a first-line and second-line treatment for high-risk patients with myelofibrosis with platelet counts less than 50,000 who are not candidates for transplants. and as a second-line treatment for lower-risk and higher-risk patients with myelofibrosis with platelet counts equal to or greater than 50,000 who are not candidates for transplant. With respect to patient access, our payer team continues to successfully expand coverage for Bonjo with both commercial and Medicare plans. For example, Caremark CVS, the largest PVM, is now covering Bonjo consistent with our label and NCCM guidelines. CTI Access, our patient services team, has been able to minimize coverage denials and affordability issues and provide Bonjo Bridge Therapy for those patients waiting for coverage. In summary, I am very pleased with the launch progress and growth of Bonjo in our first full quarter, where we recorded $12.3 million in net revenue. These results could not have happened without the tremendous contributions from our entire organization. including a special group of highly skilled, passionate, and dedicated people representing market access, marketing, and sales who are all committed to one common mission, identifying and helping MF patients who can benefit from Bonjo. I will now turn the call over to David to review our quarterly financials. David?