On August 5, 2021 CTI BioPharma Corp. (Nasdaq: CTIC) reported its financial results for the second quarter ended June 30, 2021 (Press release, CTI BioPharma, AUG 5, 2021, View Source [SID1234585873]).
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"This past quarter, we continued to advance pacritinib towards a potential U.S. approval and commercial launch this year. The U.S. Food and Drug Administration’s acceptance with priority review of our NDA submission for the use of pacritinib in myelofibrosis patients with severe thrombocytopenia underscores the unmet need in this area," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. "With a PDUFA target action date of November 30, 2021, and commercial preparations already well underway, we will be well positioned for a potential U.S. launch later this year. We are working closely with the FDA during the review of our application and we continue to advance our commercial launch activities."
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
Second Quarter Financial Results
Operating loss was $19.5 million and $36.6 million for the three and six months ended June 30, 2021, respectively, compared to operating loss of $10.0 million and $21.9 million for the corresponding periods in 2020. The increase in operating loss for the three and six months ended June 30, 2021 as compared to the comparable periods in 2020 resulted primarily from increases in research and development and general and administrative activities associated with continued development and preparation for the potential commercialization of pacritinib.
Net loss for the three months ended June 30, 2021 was $19.7 million, or $0.21 for basic and diluted loss per share, compared to net loss of $14.0 million, or $0.19 for basic and diluted loss per share, for the same period in 2020. Net loss for the six months ended June 30, 2021 was $36.9 million, or $0.44 for basic and diluted loss per share, compared to net loss of $26.2 million, or $0.38 for basic and diluted loss per share, for the same period in 2020.
As of June 30, 2021, cash, cash equivalents and short-term investments totaled $71.9 million, as compared to $52.5 million as of December 31, 2020. We expect our current cash and cash equivalents will enable 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 second quarter 2021 financial results and provide an update on business activities today, August 5 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 6891246. 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 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.