On June 1, 2021 CTI BioPharma Corp. (Nasdaq: CTIC) reported its financial results for the first quarter ended March 31, 2021 (Press release, CTI BioPharma, JUN 1, 2021, View Source [SID1234583313]).

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"The U.S. Food and Drug Administration’s (FDA) acceptance of our New Drug Application (NDA) for pacritinib with priority review and a Prescription Drug User Fee Act (PDUFA) action date of November 30, 2021 brings us one step closer to providing pacritinib to myelofibrosis patients with severe thrombocytopenia who are underserved by existing therapies," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. "We continue to work diligently on our commercial preparedness and expect to be ready to launch pacritinib in the United States this year, pending approval by the FDA. To that end, over the last quarter, we progressed key pre-commercial activities to prepare for a successful and rapid launch upon approval, including market access, distribution and supply chain, disease education and field force planning and deployment. We look forward to continuing these efforts, and to work closely with the FDA during its review of our application."

Expected Milestones

PDUFA action date – November 30, 2021
Expected U.S. commercial launch of pacritinib – by the end of 2021
Reporting of interim analysis from the Phase 3 PRE-VENT trial in hospitalized patients with severe COVID-19 – Q3 2021
First Quarter Financial Results
Operating loss was $17.1 million and $11.9 million for the three months ended March 31, 2021 and 2020, respectively. The increase in operating loss resulted primarily from increases in research and development and general and administrative activities associated with continued development and preparation for the commercialization of pacritinib.

Net loss for the three months ended March 31, 2021 was $17.3 million, or $0.23 for basic and diluted loss per share, as compared to a net loss of $12.2 million, or $0.20 for basic and diluted loss per share, for the same period in 2020.

As of March 31, 2021, cash, cash equivalents and short-term investments totaled $37.2 million, as compared to $52.5 million as of December 31, 2020. On April 6, 2021 we completed an equity financing with net proceeds of $53.8 million, which enables us to fund our operations into the fourth quarter of 2021.

Conference Call and Webcast
CTI will host a conference call and webcast to review its first quarter 2021 financial results and provide an update on business activities today, June 1 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 9343326. 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 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 x 109/L, 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 result from 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, and represent an area of significant area of unmet medical need.