On November 10, 2020 CTI BioPharma Corp. (Nasdaq: CTIC) reported its financial results for the third quarter and nine months ended September 30, 2020 (Press release, CTI BioPharma, NOV 10, 2020, View Source [SID1234570490]).
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"This past quarter we made significant progress in our pacritinib development program. We recently announced the initiation of our rolling New Drug Application (NDA) submission for pacritinib in myelofibrosis patients with severe thrombocytopenia, following a productive Pre-NDA meeting with the U.S. Food and Drug Administration (FDA) on how pacritinib could address the unmet need of this population, which includes both front-line treatment-naïve patients and patients with prior exposure to JAK2 inhibitors," said Adam R. Craig, M.D., Ph.D. "The NDA submission package will be based on available data from the completed Phase 3 PERSIST-1 and PERSIST-2, and the Phase 2 PAC203 trials, and we expect to complete the submission in the first quarter of 2021. Additionally, we have started pre-commercial activities in preparation for a commercial launch in 2021, subject to priority review."
Expected Milestones
Oral presentation of preclinical and Phase 1 trial data of pacritinib in acute graft-versus-host disease (GVHD) at American Society of Hematology (ASH) (Free ASH Whitepaper) 2020 – December 6, 2020
Expected completion of rolling NDA submission for pacritinib in myelofibrosis patients with severe thrombocytopenia – Q1 2021
Reporting of interim analysis from the Phase 3 PRE-VENT trial in hospitalized patients with severe COVID-19 –First half of 2021
Third Quarter Financial Results
Operating loss was $11.0 million and $33.0 million for the three and nine months ended September 30, 2020, respectively, compared to an operating loss of $9.7 million and $31.2 million for the respective periods in 2019. Operating loss for the three months ended September 30, 2020 as compared to the comparable period in 2019 resulted primarily from a decrease in license and contract revenues. The increase in operating loss for the nine months ended September 30, 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 collectability.
No revenues were recognized for the three and nine months ended September 30, 2020, while revenues of $2.3 million and $3.3 million, respectively, were recognized for the comparable periods in 2019. License and contract revenues in 2019 resulted from royalty and other revenues recognized from Les Laboratoires Servier and Institut de Recherches Internationales Servier ("Servier") and 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 September 30, 2020 was $11.3 million, or $0.15 for basic and diluted loss per share, compared to net loss of $10.0 million, or $0.17 for basic and diluted loss per share, for the same period in 2019. Net loss for the nine months ended September 30, 2020 was $37.4 million, or $0.54 for basic and diluted loss per share, compared to net loss of $31.8 million, or $0.55 for basic and diluted loss per share, for the same period in 2019.
As of September 30, 2020, cash, cash equivalents and short-term investments totaled $57.4 million, compared to $33.7 million as of December 31, 2019. We expect current cash, cash equivalents and short-term investments 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 third quarter 2020 financial results and provide an update on business activities today, November 10 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 5504037. 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.