CTI BioPharma Corp.

Good afternoon. Thank you for standing by. Welcome to CTI Biopharma's third quarter 2022 earnings call. During today's presentation, all parties will be in listen-only mode. This conference is being recorded today, November 7, 2022. To ask a question during the session, you will need to press star 1-1 on your telephone. You will then hear an automated message advising your hand is raised. I'd now like to turn the conference over to Dr. Adam Craig, CEO and President of CTI Biopharma. Please go ahead.

Thank you, Liz, and welcome to this afternoon's conference call. Joining me today are David Kersky, Chief Financial Officer, and Jim Fong, Chief Commercial Officer. Following formal remarks, the conference 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 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 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 may cause actual results to differ materially from those expressed in the forward-looking statements, as well as the risks related to our business, please see our periodic reports filed with the SEC. Today, I'm delighted to share our accomplishments with the launch of Vonjo as we work towards becoming the market leader in cytopenic myelofibrosis by offering a safe, simple, and effective therapy for patients with an important medical need. As a reminder, the FDA approved Vonjo Procritinib in February for the treatment of adults with myelofibrosis with a platelet count below 50 times 10 to 9 per liter. In the United States, of the approximately 21,000 patients with myelofibrosis, two-thirds have cytopenias, that is, thrombocytopenia and or anemia, resulting either from disease or commonly from toxicity of other approved therapies such as roxalignib. 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 an overall median survival of just 15 months. The commercial launch of Vonjo in the United States continues to exceed our internal projections. Today, we are pleased to report $18.2 million in net product revenue for the third quarter, reflecting a 48% increase in sales compared to the second quarter. Vonjo is being actively prescribed to patients with platelet counts less than 50 times 10 to 9 per liter, and we understand that Vonjo is also being used spontaneously in patients with higher platelet counts. The growth in the uptake of Vonjo has occurred both in the community and academic settings, reflecting growing awareness among healthcare providers that Vonjo is differentiated from existing MF therapies, and they can be considered a new standard of care for the treatment of cytopenic MF. The inclusion of Vonjo in the NCCCN clinical practice guidelines in oncology for myeloprolifted neoplasms earlier this year has further reinforced Vonjo's meaningful role in the treatment of MS. Our medical affairs team continues to educate health care providers on these guidelines, where Vonjo is the only approved JAK inhibitor recommended by the NCCCN, regardless of platelet count. Over the last six months, we've continued to learn more about the potential mechanisms of action of Vondra in cytopenic MF. In September, at SOHO22, we presented new data that showed procritinib to be a highly potent inhibitor of ACVR1. ACVR1 mediates hepcidin production, and its inhibition is thought to lead to improvements in transfusion independence and anemia in MF patients. Our analyses demonstrate that treatment with Bondro at the approved dose of 200 mg twice daily led to improvements in transfusion independence and anemia when compared to best available therapy in invaluable patients treated on the Phase III Persist-2 study. We've heard from healthcare providers that a clinically meaningful anemia benefit could be an important factor in the decision-making with respect to the treatment of cytopenic myelofibrosis. As our understanding of this benefit expands, we look forward to presenting additional data on this topic during an oral presentation at ASH 2022 next month. I'll now turn the call over to our Chief Commercial Officer, Jim Fong, to discuss the highlights of our Vonjo launch. Jim.

Thank you, Adam. As Adam just mentioned, we are pleased to announce $18.2 million in net product revenue for Vonjo this quarter. a 48% growth compared to the second quarter. We are very pleased by the robust uptake of Vonjo in just our second full quarter of launch and are confident in our ability to deliver strong growth over the coming quarters. Vonjo is a simple, safe, and effective new treatment option that addresses the urgent need of existing MF patients. Our ongoing launch momentum stems from the effective execution of the Vonjo launch plan by our sales, marketing, market access, and medical affairs teams who are deeply committed to making Vonjo the market leader in cytopenic myelofibrosis. Our commercial strategy continues to focus on our three core Vonjo launch objectives. One, build Vonjo awareness among myelofibrosis healthcare providers. Two, drive adoption and utilization with 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. Our promotional efforts and activities are driving growth in Vonjo brand awareness among our target HCP audiences. Recent market research studies indicates we have already achieved brand awareness that's equal to or exceeding in Rebic, which has been on the market for several years. We continue to invest heavily in peer-to-peer programs that are designed to educate our ATPs about BonJo, identify the appropriate patients, and ultimately support BonJo demand. Our field teams have executed approximately 160 peer-to-peer programs through the end of the third quarter, programs that had reached more than 1,800 HCPs. This strong HCP participation underscores the broad interest in cytopenic myelofibrosis, and more specifically, in Vonjo's differentiated clinical value proposition to address the unique needs of these patients. We are also seeing steady growth in new prescribers, new patients, new prescriptions, and refills across all lines of therapy in both community and academic settings. Approximately 80% of our accounts have reordered Vonjo multiple times. Feedback from the field and market research indicate that future prescription growth will result from the early identification of second-line cytopenic myelofibrosis patients. With respect to patient access, Our payer team continues to successfully optimize coverage decisions with payers for VONGO as both commercial and Medicare plans now have approximately 70% and 90% coverage, respectively. In addition, our patient services team has effectively minimized coverage denials and affordability issues and provided VONGO bridge therapy for those patients waiting for coverage. Thus, the vast majority of patients who are prescribed VONGO receive it. In summary, I am very pleased with Avonjo's launch progress and growth in the third quarter, where we've recorded $18.2 million in net revenue, a reflection of the clear unmet need that exists for cytopenic MF, our customers' excitement for Avonjo's differentiated clinical profile, and our team's strong execution in the field. I will now turn the call over to David to review our quarterly financials. David?