On March 17, 2021 CTI BioPharma Corp. (Nasdaq: CTIC) reported its financial results for the fourth quarter and full year ended December 31, 2020 (Press release, CTI BioPharma, MAR 17, 2021, View Source [SID1234576792]).
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"This past quarter, CTI has executed on the critical clinical, regulatory and commercial activities that will allow for the potential U.S. approval and commercial launch of pacritinib in 2021," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. "We continue to work diligently on our rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) for pacritinib, for use in myelofibrosis patients with severe thrombocytopenia, and are on track to complete the submission before the end of this month. Pending priority review and approval by the FDA, we are planning to launch pacritinib in the United States by the end of the year. Over the last quarter, we have focused on the key pre-commercial activities that will enable a successful launch, including the recruitment of key leadership roles in marketing and sales, and the initiation of our disease awareness, market access, and field force strategies. We look forward to being able to provide pacritinib to myelofibrosis patients who are underserved by existing therapies."
Expected Milestones
Expected completion of rolling NDA submission for pacritinib in myelofibrosis patients with severe thrombocytopenia – Q1 2021
Expected FDA approval and U.S. commercial launch of pacritinib in myelofibrosis patients with severe thrombocytopenia – by end of 2021
Reporting of interim analysis from the Phase 3 PRE-VENT trial in hospitalized patients with severe COVID-19 – mid-2021
Fourth Quarter Financial Results
Operating loss was $14.8 million and $47.8 million for the three months and year ended December 31, 2020, respectively, as compared to an operating loss of $9.5 million and $40.7 million for the respective periods in 2019. The increase in operating loss for the three months ended December 31, 2020, as compared to the comparable period in 2019, resulted primarily from more extensive research and development activities. The increase in operating loss for the year ended December 31, 2020, as compared to the comparable period in 2019, resulted primarily from the recording of a full allowance against certain VAT receivables due to a reduced certainty of their collectability.
No revenues were recognized for the three months and year ended December 31, 2020 or for the three months ended December 31, 2019, as compared to revenues of $3.3 million recognized for the year ended December 31, 2019. License and contract revenues in 2019 resulted from royalty and other payments received from Les Laboratoires Servier and Institut de Recherches Internationales Servier ("Servier") and were related to the asset purchase agreement and transition period activities pursuant to the terms of the Termination and Transfer Agreement with Servier.
Net loss for the three months ended December 31, 2020 was $15.0 million, or $0.20 for basic and diluted loss per share, as compared to a net loss of $8.2 million, or $0.14 for basic and diluted loss per share, for the same period in 2019. Net loss for the year ended December 31, 2020 was $52.5 million, or $0.74 for basic and diluted loss per share, as compared to a net loss of $40.0 million, or $0.69 for basic and diluted loss per share, for the same period in 2019.
As of December 31, 2020, cash, cash equivalents and short-term investments totaled $52.5 million, as compared to $33.7 million as of December 31, 2019. We expect our current cash, cash equivalents and short-term investments will enable us to fund our operations into the second quarter of 2021.
Conference Call and Webcast
CTI will host a conference call and webcast to review its fourth quarter 2020 financial results and provide an update on business activities today, March 17 at 4:30 PM ET. To access the live call by phone please dial (877) 735-2860 (domestic) or (602) 563-8791 (international); the conference ID is 9095063. A live audio webcast of the event may also be accessed through the "Investors" section of CTI’s website at www.ctibiopharma.com. A replay of the webcast will be available for 30 days following the event.
About Myelofibrosis and Severe Thrombocytopenia
Myelofibrosis is a type of bone marrow cancer that results in formation of fibrous scar tissue and can lead to severe thrombocytopenia and anemia, weakness, fatigue and enlarged spleen and liver. Patients with severe thrombocytopenia are estimated to make up more than one-third of patients treated for myelofibrosis, or approximately 17,000 people in the United States and Europe. Severe thrombocytopenia, defined as blood platelet counts of less than 50,000 per microliter, has been shown to result in overall survival rates of just 15 months. Thrombocytopenia in patients with myelofibrosis is associated with the underlying disease but has also been shown to correlate with treatment with ruxolitinib, which can lead to dose reductions, and as a result, may potentially reduce clinical benefit. Survival in patients who have discontinued ruxolitinib therapy is further compromised, with an average overall survival of seven to 14 months. Myelofibrosis patients with severe thrombocytopenia have limited treatment options, creating a significant area of unmet medical need.