1. SEATTLE, Feb. 25, 2021 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced that management will provide a corporate overview at the Cowen 41st Annual Health Care Conference at 12:10 p.m. EST. The conference will be held in a virtual meeting format.

    Presentation details:

    Event: Cowen 41st Annual Health Care Conference

    Date: Thursday, Mar. 4, 2021

    Time: 12:10 p.m. EST

    The presentation will be webcast live and available for replay from the Investors section of CTI BioPharma's website at www.ctibiopharma.com.

    About CTI BioPharma Corp.

    We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. We concentrate our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are focused on evaluating pacritinib, our sole product candidate currently in active late-stage development, for the treatment of adult patients with myelofibrosis. In addition, we have recently started developing pacritinib for use in hospitalized patients with severe COVID-19, in response to the COVID-19 pandemic. We are headquartered in Seattle, Washington.

    CTI BioPharma Investor Contacts:

    Maeve Conneighton/Maghan Meyers

    +212-600-1902

     

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  2. SEATTLE, Feb. 24, 2021 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ: CTIC) today announced that the Compensation Committee of its Board of Directors granted equity awards to three new employees with a grant date of February 24, 2021, as equity inducement awards outside of the Company's Amended and Restated 2017 Equity Incentive Plan (but under the terms of the Amended and Restated 2017 Equity Incentive Plan) and material to the employees' acceptance of employment with the company.  The equity awards were approved on February 24, 2021, in accordance with Nasdaq Listing Rule 5635(c)(4).

    The employees received options to purchase an aggregate of 92,000 shares of CTI BioPharma common stock.  The options have an exercise price of $3.18, which is equal…

    SEATTLE, Feb. 24, 2021 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ: CTIC) today announced that the Compensation Committee of its Board of Directors granted equity awards to three new employees with a grant date of February 24, 2021, as equity inducement awards outside of the Company's Amended and Restated 2017 Equity Incentive Plan (but under the terms of the Amended and Restated 2017 Equity Incentive Plan) and material to the employees' acceptance of employment with the company.  The equity awards were approved on February 24, 2021, in accordance with Nasdaq Listing Rule 5635(c)(4).

    The employees received options to purchase an aggregate of 92,000 shares of CTI BioPharma common stock.  The options have an exercise price of $3.18, which is equal to the closing price of CTI BioPharma common stock on February 24, 2021, the grant date of the awards. One-fourth of the options will vest on each anniversary of the employee's date of hire, subject to the employee's continued employment with CTI BioPharma on such vesting dates. The options have a ten-year term.

    About CTI BioPharma Corp.

    We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. We concentrate our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are focused on evaluating pacritinib, our sole product candidate currently in active late-stage development, for the treatment of adult patients with myelofibrosis. In addition, we have recently started developing pacritinib for use in hospitalized patients with severe COVID-19, in response to the COVID-19 pandemic. We are headquartered in Seattle, Washington.

    CTI BioPharma Investor Contacts:

    Maeve Conneighton/Maghan Meyers

    +212-600-1902

    CTI BioPharma Corp. Logo (PRNewsFoto/Cell Therapeutics, Inc.)

     

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  3. SEATTLE, Feb. 10, 2021 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ: CTIC) today announced that the Compensation Committee of its Board of Directors granted equity awards to two new employees with a grant date of February 10, 2021, as equity inducement awards outside of the Company's Amended and Restated 2017 Equity Incentive Plan (but under the terms of the Amended and Restated 2017 Equity Incentive Plan) and material to the employees' acceptance of employment with the company. The equity awards were approved on February 10, 2021, in accordance with Nasdaq Listing Rule 5635(c)(4).

    The employees received options to purchase an aggregate of 160,000 shares of CTI BioPharma common stock. The options have an exercise price of $3.45, which is equal…

    SEATTLE, Feb. 10, 2021 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ: CTIC) today announced that the Compensation Committee of its Board of Directors granted equity awards to two new employees with a grant date of February 10, 2021, as equity inducement awards outside of the Company's Amended and Restated 2017 Equity Incentive Plan (but under the terms of the Amended and Restated 2017 Equity Incentive Plan) and material to the employees' acceptance of employment with the company. The equity awards were approved on February 10, 2021, in accordance with Nasdaq Listing Rule 5635(c)(4).

    The employees received options to purchase an aggregate of 160,000 shares of CTI BioPharma common stock. The options have an exercise price of $3.45, which is equal to the closing price of CTI BioPharma common stock on February 10, 2021, the grant date of the awards. One-fourth of the options will vest on each anniversary of the employee's date of hire, subject to the employee's continued employment with CTI BioPharma on such vesting dates. The options have a ten-year term.

    About CTI BioPharma Corp.

    We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. We concentrate our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are focused on evaluating pacritinib, our sole product candidate currently in active late-stage development, for the treatment of adult patients with myelofibrosis. In addition, we have recently started developing pacritinib for use in hospitalized patients with severe COVID-19, in response to the COVID-19 pandemic. We are headquartered in Seattle, Washington.

    CTI BioPharma Investor Contacts:

    Maeve Conneighton/Maghan Meyers

    +212-600-1902

    CTI BioPharma Corp. Logo (PRNewsFoto/Cell Therapeutics, Inc.)

     

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  4. SEATTLE, Jan. 28, 2021 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ: CTIC) today announced that the Compensation Committee of its Board of Directors granted equity awards to two new employees with a grant date of January 28, 2021, as equity inducement awards outside of the Company's Amended and Restated 2017 Equity Incentive Plan (but under the terms of the Amended and Restated 2017 Equity Incentive Plan) and material to the employees' acceptance of employment with the company.  The equity awards were approved on January 28, 2021, in accordance with Nasdaq Listing Rule 5635(c)(4).

    The employees received options to purchase an aggregate of 200,000 shares of CTI BioPharma common stock.  The options have an exercise price of $3.30, which is equal…

    SEATTLE, Jan. 28, 2021 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ: CTIC) today announced that the Compensation Committee of its Board of Directors granted equity awards to two new employees with a grant date of January 28, 2021, as equity inducement awards outside of the Company's Amended and Restated 2017 Equity Incentive Plan (but under the terms of the Amended and Restated 2017 Equity Incentive Plan) and material to the employees' acceptance of employment with the company.  The equity awards were approved on January 28, 2021, in accordance with Nasdaq Listing Rule 5635(c)(4).

    The employees received options to purchase an aggregate of 200,000 shares of CTI BioPharma common stock.  The options have an exercise price of $3.30, which is equal to the closing price of CTI BioPharma common stock on January 28, 2021, the grant date of the awards. One-fourth of the options will vest on each anniversary of the employee's date of hire, subject to the employee's continued employment with CTI BioPharma on such vesting dates. The options have a ten-year term.

    About CTI BioPharma Corp.

    We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. We concentrate our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are focused on evaluating pacritinib, our sole product candidate currently in active late-stage development, for the treatment of adult patients with myelofibrosis. In addition, we have recently started developing pacritinib for use in hospitalized patients with severe COVID-19, in response to the COVID-19 pandemic. We are headquartered in Seattle, Washington.

    CTI BioPharma Investor Contacts:

    Maeve Conneighton/Maghan Meyers

    +212-600-1902

    CTI BioPharma Corp. Logo (PRNewsFoto/Cell Therapeutics, Inc.)

     

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  5. SEATTLE, Dec. 8, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced that management will provide a corporate overview at The JMP Securities Hematology Summit at 3:00 p.m. EST. The conference will be held in a virtual meeting format.

    Presentation details:

    Event: The JMP Securities Hematology Summit
    Date: Tuesday, Dec. 15
    Time: 3:00 p.m. EST

    The presentation will be webcast live and available for replay from the Investors section of CTI BioPharma's website at www.ctibiopharma.com.

    About CTI BioPharma Corp.
    We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. We…

    SEATTLE, Dec. 8, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced that management will provide a corporate overview at The JMP Securities Hematology Summit at 3:00 p.m. EST. The conference will be held in a virtual meeting format.

    Presentation details:

    Event: The JMP Securities Hematology Summit

    Date: Tuesday, Dec. 15

    Time: 3:00 p.m. EST

    The presentation will be webcast live and available for replay from the Investors section of CTI BioPharma's website at www.ctibiopharma.com.

    About CTI BioPharma Corp.

    We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. We concentrate our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are focused on evaluating pacritinib, our sole product candidate currently in active late-stage development, for the treatment of adult patients with myelofibrosis. In addition, we have recently started developing pacritinib for use in hospitalized patients with severe COVID-19, in response to the COVID-19 pandemic. We are headquartered in Seattle, Washington.

    CTI BioPharma Investor Contacts:

    Maeve Conneighton/Maghan Meyers

    +212-600-1902

    CTI BioPharma Corp. Logo (PRNewsFoto/Cell Therapeutics, Inc.)

     

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  6. SEATTLE, Dec. 6, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced an oral presentation supporting the Company's pacritinib development program in the prevention of acute graft versus host disease (GVHD) at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition, being held virtually December 5-8, 2020. The results are from an investigator-sponsored Phase 1/2 study conducted at the Mayo Clinic and Moffit Cancer Center.

    "The data presented today at ASH highlights the potential for the expanded use of pacritinib. Acute GVHD following allogeneic hematopoietic cell transplantation results in higher rates of morbidity and mortality, compromises the anti-leukemic response of the graft and occurs despite standard immunosuppressive prophylaxis, rendering it an area where new therapeutic options are needed," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. "These data demonstrate that in this Phase 1/2 study, adding pacritinib to the standard prophylaxis of sirolimus and low-dose tacrolimus resulted in a significant reduction in the expected acute GVHD rates in patients within the first 100 days of therapy as compared to historical data, without compromising transplantation outcomes and without any new safety concerns. We are encouraged by these data, and look forward to further evaluating pacritinib's efficacy and safety in this indication in the on-going Phase 2 clinical trial."

    All presentation materials will be available at ctibiopharma.com following the presentations.

    Biological and Clinical Impact of JAK2/mTOR Blockade in GVHD Prevention: Preclinical and Phase 1 / 2 Study Results

    Results from an investigator-sponsored (Mayo Clinic and Moffit Cancer Center) Phase 1/2 study of GVHD prophylaxis for allogeneic hematopoietic cell transplantation (alloHCT) using pacritinib, sirolimus, low-dose tacrolimus are being presented today, Sunday, December 6 at 10 a.m. PT in an oral presentation session.

    Abstract: No. 355

    Summary: This single-arm Phase 1/2 study (NCT02891603) tested the safety, pharmacodynamics and efficacy of pacritinib when administered with sirolimus plus low-dose tacrolimus (PAC/SIR/TAC) after alloHCT. A 3+3 dose escalation design was planned using three doses of pacritinib (100 mg QD, 100 mg BID, 200 mg BID) in combination with standard sirolimus and low-dose tacrolimus immunosuppressive therapy. Efficacy endpoints included acute GVHD (aGVHD) rate at day 100.

    PAC 100 mg twice daily (BID), dose level 2, was selected as the recommended Phase 2 dose based on its biological activity and safety profile. Preliminary evidence of the benefit of adding pacritinib to standard immunosuppressive therapy in reducing the rates of aGVHD was reported, with a 25% rate of grade 2-4 aGVHD across all dose cohorts, and 17% at the recommended Phase 2 dose of 100 mg BID, as compared to grade 2-4 aGVHD incidence rate of 43% expected with sirolimus plus low-dose tacrolimus administered alone1. No compromise in alloHCT outcome or major safety concerns were observed.  Futher, there was no evidence of cytopenias, impaired immune reconstitution, or cytomegalovirus (CMV) reactivation. A Phase 2 clinical trial to fully evaluate efficacy in GVHD prevention is ongoing (NCT02891603).

    About Pacritinib

    Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, IRAK1, and CSF1R. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukemia and lymphoma. In addition to myelofibrosis, the kinase profile of pacritinib suggests its potential therapeutic utility in conditions such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), and chronic lymphocytic leukemia (CLL), due to its inhibition of c-fms, IRAK1, JAK2 and FLT3.

    About CTI BioPharma Corp.

    We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. We concentrate our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are focused on evaluating pacritinib, our sole product candidate currently in active late-stage development, for the treatment of adult patients with myelofibrosis. In addition, we have recently started developing pacritinib for use in the prevention of acute graft versus host disease and in hospitalized patients with severe COVID-19, in response to the COVID-19 pandemic. We are headquartered in Seattle, Washington.

    Forward-Looking Statements

    Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: our ability to successfully demonstrate the safety and efficacy of pacritinib in various indications; our ability to receive regulatory approval for pacritinib pursuant to the accelerated approval pathway or at all; our planned commercialization of pacritinib; our ability to enter into potential partnerships relating to our commercial launch of pacritinib; and those risks more fully discussed in the section entitled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2019 and subsequent quarterly reports on Form 10-Q. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "CTI BioPharma" and the CTI BioPharma logo are registered trademarks or trademarks of CTI BioPharma Corp. in various jurisdictions. All other trademarks belong to their respective owner.

    CTI BioPharma Investor Contacts:

    Maeve Conneighton/Maghan Meyers

    +212-600-1902

    1. Pidala et al, Oral Presentation, Abstract 355, ASH 2020.

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  7. SEATTLE, Nov. 30, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced that an article highlighting pacritinib data was published in Blood Advances. The article, titled "Determining the Recommended Dose of Pacritinib: Results from the PAC203 Phase 2 Dose-Finding Study in Patients with Advanced Myelofibrosis" is available online via this link.

    "Having recently announced the start of a rolling NDA submission for pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia, a patient population with reduced survival and limited therapeutic options, we continue to be committed to adding to the growing body of evidence underscoring the efficacy and safety profile of pacritinib," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. "As our application will consist of a data package from the PERSIST-1, PERSIST-2 and PAC203 Phase 2 trials, with the ongoing Phase 3 PACIFICA trial expected to be completed as a post-marketing commitment, the data published today support our belief that pacritinib has the potential to become an important treatment in this disease setting, pending regulatory approval."

    PAC203 Phase 2 was an open-label, randomized, dose-finding trial of pacritinib in patients with myelofibrosis who were previously treated with ruxolitinib. Patients were randomized 1:1:1 to pacritinib 100 mg daily (QD), 100 mg BID, or 200 mg BID. The trial demonstrated that pacritinib 200 mg BID had a favorable benefit risk profile. Spleen volume response (SVR) rates were highest among patients treated with pacritinib 200 mg BID who had a baseline platelet count of less than 50 x 109/L. Overall, the study data supported the selection of the pacritinib 200 mg BID for use in the ongoing Phase 3 PACIFICA study of pacritinib in patients with myelofibrosis with severe thrombocytopenia.

    About Pacritinib

    Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, IRAK1, and CSF1R. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukemia and lymphoma. In addition to myelofibrosis, the kinase profile of pacritinib suggests its potential therapeutic utility in conditions such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), and chronic lymphocytic leukemia (CLL), due to its inhibition of c-fms, IRAK1, JAK2 and FLT3.

    About CTI BioPharma Corp.

    We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. We concentrate our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are focused on evaluating pacritinib, our sole product candidate currently in active late-stage development, for the treatment of adult patients with myelofibrosis. In addition, we have recently started developing pacritinib for use in hospitalized patients with severe COVID-19, in response to the COVID-19 pandemic. We are headquartered in Seattle, Washington.

    Forward-Looking Statements

    Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: our ability to successfully demonstrate the safety and efficacy of pacritinib; our ability to complete a rolling NDA for pacritinib in the timeline currently anticipated; our ability to receive regulatory approval for pacritinib pursuant to the accelerated approval pathway or at all; our planned commercialization of pacritinib; our ability to enter into potential partnerships relating to our commercial launch of pacritinib; and those risks more fully discussed in the section entitled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2019 and subsequent quarterly reports on Form 10-Q. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements. "CTI BioPharma" and the CTI BioPharma logo are registered trademarks or trademarks of CTI BioPharma Corp. in various jurisdictions. All other trademarks belong to their respective owner.

    CTI BioPharma Investor Contacts:

    Maeve Conneighton/Maghan Meyers

    +212-600-1902

     

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  8. SEATTLE, Nov. 10, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today reported its financial results for the third quarter and nine months ended September 30, 2020.

    "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…

    SEATTLE, Nov. 10, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today reported its financial results for the third quarter and nine months ended September 30, 2020.

    "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) 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.

    About CTI BioPharma Corp.

    We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. We concentrate our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are focused on evaluating pacritinib, our sole product candidate currently in active development, for the treatment of adult patients with myelofibrosis. In addition, we have recently started developing pacritinib for use in hospitalized patients with severe COVID-19, in response to the COVID-19 pandemic. We are headquartered in Seattle, Washington.

    Forward-Looking Statements

    Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: our ability to conduct and complete clinical trials in our currently anticipated timeframes; our ability to successfully demonstrate the safety and efficacy of pacritinib; our expectations regarding the completion and outcome of our PACIFICA Phase 3 trial and our PRE-VENT Phase 3 trial; the risk that the FDA may determine that the benefit/risk profile of pacritinib at the dose selected for the PACIFICA Phase 3 trial does not support approval; the risk that the FDA may determine that the benefit/risk profile of pacritinib in the PRE-VENT Phase 3 trial does not support approval or requires additional clinical data for approval; the risk that pacritinib may fail in its development through our PACIFICA and PRE-VENT trial; our ability to submit a rolling NDA for pacritinib in the timeline currently anticipated; our ability to receive regulatory approval for pacritinib pursuant to the accelerated approval pathway or at all; the risk that pacritinib may be delayed to a point where it is not commercially viable; the accuracy of our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations; risks and uncertainties related to the COVID-19 pandemic as it relates to our operations and ongoing clinical trials; and those risks more fully discussed in the section entitled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2019 and subsequent quarterly reports on Form 10-Q. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements. "CTI BioPharma" and the CTI BioPharma logo are registered trademarks or trademarks of CTI BioPharma Corp. in various jurisdictions. All other trademarks belong to their respective owner.

    CTI BioPharma Investor Contacts:

    Maeve Conneighton/Maghan Meyers

    +212-600-1902

    (tables follow)

    CTI BioPharma Corp.

    Condensed Consolidated Statements of Operations

    (In thousands, except per share amounts)

    (unaudited)





    Three Months Ended

     September 30,



    Nine Months Ended

     September 30,



    2020



    2019



    2020



    2019

    License and contract revenues

    $





    $

    2,289





    $





    $

    3,345



    Operating costs and expenses:















    Research and development

    6,994





    7,598





    16,457





    19,126



    General and administrative

    4,052





    4,403





    12,316





    14,662



    Restructuring expenses













    794



    Other operating expenses









    4,200







    Total operating costs and expenses

    11,046





    12,001





    32,973





    34,582



    Loss from operations

    (11,046)





    (9,712)





    (32,973)





    (31,237)



    Non-operating income (expense):















    Interest income

    25





    276





    187





    1,003



    Interest expense

    (115)





    (240)





    (419)





    (803)



    Amortization of debt discount and issuance costs

    (131)





    (131)





    (391)





    (391)



    Foreign exchange gain (loss)

    4





    (240)





    (79)





    (409)



    Loss on dissolution of majority-owned subsidiary









    (3,774)







    Total non-operating expense, net

    (217)





    (335)





    (4,476)





    (600)



    Net loss before noncontrolling interest

    (11,263)





    (10,047)





    (37,449)





    (31,837)



    Noncontrolling interest













    5



    Net loss

    $

    (11,263)





    $

    (10,047)





    $

    (37,449)





    $

    (31,832)



    Basic and diluted net loss per common share

    $

    (0.15)





    $

    (0.17)





    $

    (0.54)





    $

    (0.55)



    Shares used in calculation of basic and diluted net loss per common share:

    73,712





    57,974





    69,966





    57,973



     

    Balance Sheet Data (unaudited):



    (amounts in thousands)





    September 30,



    December 31,





    2020



    2019

    Cash and cash equivalents



    $

    45,301





    $

    31,144



    Short-term investments



    12,111





    2,522



    Working capital



    44,169





    17,092



    Total assets



    63,091





    46,280



    Current portion of long-term debt



    5,658





    4,812



    Long-term debt, less current portion







    4,455



    Total stockholders' equity



    46,819





    17,930



     

    CTI BioPharma Corp. Logo (PRNewsFoto/Cell Therapeutics, Inc.)

     

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  9. SEATTLE, Nov. 4, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced an oral presentation supporting the Company's pacritinib development program in graft versus host disease (GVHD) at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition, being held virtually December 5- 8, 2020.

    The details of the presentation are as follows:

    Abstract Title: Biological and Clinical Impact of JAK2/mTOR Blockade in GVHD Prevention: Preclinical and Phase I Trial Results
    Session Name: Clinical Allogeneic Transplantation; Acute and Chronic GVHD, Immune Reconstitution Phase I and II Trials
    Session Number: 722
    Session Date: Sunday, December 6, 2020
    Session Time: 9:30 a.m. - 11:00 a.m. PT
    Presentation Time: 10:00 a.m. PT
    Presenter:

    SEATTLE, Nov. 4, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced an oral presentation supporting the Company's pacritinib development program in graft versus host disease (GVHD) at the 62nd American Society of Hematology (ASH) Annual Meeting & Exposition, being held virtually December 5- 8, 2020.

    The details of the presentation are as follows:

    Abstract Title: Biological and Clinical Impact of JAK2/mTOR Blockade in GVHD Prevention: Preclinical and Phase I Trial Results

    Session Name: Clinical Allogeneic Transplantation; Acute and Chronic GVHD, Immune Reconstitution Phase I and II Trials

    Session Number: 722

    Session Date: Sunday, December 6, 2020

    Session Time: 9:30 a.m. - 11:00 a.m. PT

    Presentation Time: 10:00 a.m. PT

    Presenter: Dr. Joseph Pidala

    A copy of the abstract is available here.

    About CTI BioPharma Corp.

    We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. We concentrate our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are focused on evaluating pacritinib, our sole product candidate currently in active development, for the treatment of adult patients with myelofibrosis. In addition, we have recently started developing pacritinib for use in hospitalized patients with severe COVID-19, in response to the COVID-19 pandemic. We are headquartered in Seattle, Washington.

    CTI BioPharma Investor Contacts:

    Maeve Conneighton/Maghan Meyers

    +212-600-1902

    CTI BioPharma Corp. Logo (PRNewsFoto/Cell Therapeutics, Inc.)

     

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  10. SEATTLE, Nov. 2, 2020 /PRNewswire/ -- CTI BioPharma Corp. (CTI BioPharma) (NASDAQ:CTIC) today announced that management plans to report its third quarter 2020 financial results on Tuesday, November 10, 2020, after the close of the U.S. financial markets. Following the announcement, members of the management team will host a conference call and webcast to discuss the results and provide a general corporate update at 4:30 p.m. ET (1:30 p.m. PT).

    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…

    SEATTLE, Nov. 2, 2020 /PRNewswire/ -- CTI BioPharma Corp. (CTI BioPharma) (NASDAQ:CTIC) today announced that management plans to report its third quarter 2020 financial results on Tuesday, November 10, 2020, after the close of the U.S. financial markets. Following the announcement, members of the management team will host a conference call and webcast to discuss the results and provide a general corporate update at 4:30 p.m. ET (1:30 p.m. PT).

    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.

    About CTI BioPharma Corp.

    We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. We concentrate our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are focused on evaluating pacritinib, our sole product candidate currently in active development, for the treatment of adult patients with myelofibrosis. In addition, we have recently started developing pacritinib for use in hospitalized patients with severe COVID-19, in response to the COVID-19 pandemic. We are headquartered in Seattle, Washington.

    CTI BioPharma Investor Contacts:

    Maeve Conneighton/Maghan Meyers

    +212-600-1902

     

    CTI BioPharma Corp. Logo (PRNewsFoto/Cell Therapeutics, Inc.)

     

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  11. SEATTLE, Oct. 13, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced that it has commenced a rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration ("FDA" or "the Agency") seeking approval of pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia (platelet counts less than 50 x 109/L). CTI has previously announced the results of a recent Pre-NDA meeting with FDA where agreement was reached on an NDA submission package based upon available data from the completed Phase 3 PERSIST-1 and PERSIST-2, and the Phase 2 PAC203 trials.

    "Today we are pleased to announce the start of a rolling NDA submission that seeks to address the important unmet medical need of myelofibrosis…

    SEATTLE, Oct. 13, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced that it has commenced a rolling New Drug Application (NDA) submission to the U.S. Food and Drug Administration ("FDA" or "the Agency") seeking approval of pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia (platelet counts less than 50 x 109/L). CTI has previously announced the results of a recent Pre-NDA meeting with FDA where agreement was reached on an NDA submission package based upon available data from the completed Phase 3 PERSIST-1 and PERSIST-2, and the Phase 2 PAC203 trials.

    "Today we are pleased to announce the start of a rolling NDA submission that seeks to address the important unmet medical need of myelofibrosis patients with severe thrombocytopenia, a population that includes both front-line treatment-naïve patients and patients with prior exposure to JAK2 inhibitors," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. "We have started pre-commercial activities and are planning for a commercial launch in 2021, subject to priority review."

    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.

    About Pacritinib

    Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, IRAK1, and CSF1R. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukemia and lymphoma. In addition to myelofibrosis, the kinase profile of pacritinib suggests its potential therapeutic utility in conditions such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), and chronic lymphocytic leukemia (CLL), due to its inhibition of c-fms, IRAK1, JAK2 and FLT3.

    About CTI BioPharma Corp.

    We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. We concentrate our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are focused on evaluating pacritinib, our sole product candidate currently in active late-stage development, for the treatment of adult patients with myelofibrosis. In addition, we have recently started developing pacritinib for use in hospitalized patients with severe COVID-19, in response to the COVID-19 pandemic. We are headquartered in Seattle, Washington.

    Forward-Looking Statements

    Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: our ability to successfully demonstrate the safety and efficacy of pacritinib; our ability to complete a rolling NDA for pacritinib in the timeline currently anticipated; our ability to receive regulatory approval for pacritinib pursuant to the accelerated approval pathway or at all; our planned commercialization of pacritinib; our ability to enter into potential partnerships relating to our commercial launch of pacritinib; and those risks more fully discussed in the section entitled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2019 and subsequent quarterly reports on Form 10-Q. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements. "CTI BioPharma" and the CTI BioPharma logo are registered trademarks or trademarks of CTI BioPharma Corp. in various jurisdictions. All other trademarks belong to their respective owner.

    CTI BioPharma Investor Contacts:

    Maeve Conneighton/Maghan Meyers

    +212-600-1902

     

    CTI BioPharma Corp. Logo (PRNewsFoto/Cell Therapeutics, Inc.)

     

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  12. SEATTLE, Sept. 29, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced that following a recent Pre-NDA meeting with the U.S. Food and Drug Administration ("FDA" or "the Agency"), the Company has reached an agreement to submit an NDA for the potential accelerated approval of pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia (platelet count less than 50 x 109/L). The NDA will be based on the available data from the Company's completed Phase 3 PERSIST-1 and PERSIST-2 trials and the Phase 2 PAC203 dose-ranging trial. The FDA has agreed to a rolling NDA submission which is expected to commence within a few weeks, with completion of the NDA submission anticipated in the first quarter of 2021. The…

    SEATTLE, Sept. 29, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced that following a recent Pre-NDA meeting with the U.S. Food and Drug Administration ("FDA" or "the Agency"), the Company has reached an agreement to submit an NDA for the potential accelerated approval of pacritinib as a treatment for myelofibrosis patients with severe thrombocytopenia (platelet count less than 50 x 109/L). The NDA will be based on the available data from the Company's completed Phase 3 PERSIST-1 and PERSIST-2 trials and the Phase 2 PAC203 dose-ranging trial. The FDA has agreed to a rolling NDA submission which is expected to commence within a few weeks, with completion of the NDA submission anticipated in the first quarter of 2021. The ongoing Phase 3 PACIFICA trial is expected to be completed as a post-marketing commitment.

    "Since the completion of the PAC203 Phase 2 dose-ranging trial, we have been working collaboratively with the FDA to identify an expeditious approval pathway for pacritinib in myelofibrosis patients with severe thrombocytopenia, a patient population with an important unmet medical need due to reduced survival and limited therapeutic options. During a recent Pre-NDA meeting, we identified a data package from the PERSIST-1, PERSIST-2 and PAC203 Phase 2 trials that will serve as the basis for an accelerated approval application. In particular, we discussed risk mitigation measures to address the FDA's prior concerns regarding safety," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. "In myelofibrosis patients, severe thrombocytopenia occurs as a result of disease or drug-related toxicity from current therapies. There is no approved drug that specifically addresses the unmet need of the myelofibrosis patients who have severe thrombocytopenia. Pacritinib has demonstrated clinical benefit in treating these patients in multiple trials and now has the potential to become a new treatment option for treatment-naïve and second-line myelofibrosis patients in 2021."   

    Conference Call and Webcast

    CTI will host a conference call and webcast to discuss this announcement tomorrow, September 30, 2020 at 8:30 AM ET. To access the live call by phone please dial (877) 735-2860 (domestic) or (602) 563-8791 (international); the conference ID is 9275344. 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 anemia, weakness, fatigue and an 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. 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.

    About Pacritinib

    Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukemia and lymphoma. In addition to myelofibrosis, the kinase profile of pacritinib suggests its potential therapeutic utility in conditions such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), and chronic lymphocytic leukemia (CLL), due to its inhibition of c-fms, IRAK1, JAK2 and FLT3. 

    In March 2008, pacritinib received orphan drug designation for the treatment of primary myelofibrosis (MF), post-polycythemia vera MF, and post-essential thrombocythemia MF. 

    In August 2014, pacritinib was granted Fast Track designation by the FDA for the treatment of intermediate and high risk myelofibrosis, including, but not limited to,  patients with disease-related thrombocytopenia (low platelet counts); patients experiencing treatment-emergent thrombocytopenia on other JAK2 inhibitor therapy; or patients who are intolerant of or whose symptoms are not well controlled (sub-optimally managed) on other JAK2 therapy.

    About CTI BioPharma Corp.

    We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. We concentrate our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are focused on evaluating pacritinib, our sole product candidate currently in active development, for the treatment of adult patients with myelofibrosis. In addition, we have recently started developing pacritinib for use in hospitalized patients with severe COVID-19, in response to the COVID-19 pandemic. We are headquartered in Seattle, Washington.

    Forward-Looking Statements

    Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: our ability to conduct and complete clinical trials in our currently anticipated timeframes; our ability to successfully demonstrate the safety and efficacy of pacritinib; our expectations regarding the completion and outcome of our PACIFICA Phase 3 trial and our PRE-VENT Phase 3 trial; the risk that the FDA may determine that the benefit/risk profile of pacritinib at the dose selected for the PACIFICA Phase 3 trial does not support approval; the risk that the FDA may determine that the benefit/risk profile of pacritinib in the PRE-VENT Phase 3 trial does not support approval or requires additional clinical data for approval; the risk that pacritinib may fail in its development through our PACIFICA and PRE-VENT trial; our ability to submit a rolling NDA for pacritinib in the timeline currently anticipated; our ability to receive regulatory approval for pacritinib pursuant to the accelerated approval pathway or at all; the risk that pacritinib may be delayed to a point where it is not commercially viable; and those risks more fully discussed in the section entitled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2019 and subsequent quarterly reports on Form 10-Q. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements. "CTI BioPharma" and the CTI BioPharma logo are registered trademarks or trademarks of CTI BioPharma Corp. in various jurisdictions. All other trademarks belong to their respective owner.

    CTI BioPharma Investor Contacts:

    Maeve Conneighton/Maghan Meyers

    +212-600-1902

    CTI BioPharma Corp. Logo (PRNewsFoto/Cell Therapeutics, Inc.)

     

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  13. SEATTLE, Aug. 6, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today reported its financial results for the second quarter and six months ended June 30, 2020.

    "This past quarter we announced enrollment of the first patient in our PRE-VENT Phase 3 clinical trial of pacritinib in hospitalized patients with severe COVID-19, an important step for CTI as we work to provide a new therapeutic option for COVID-19 patients," said Adam R. Craig, M.D., Ph.D. "With regards to the PACIFICA Phase 3 trial, we continue to enroll patients but the enrollment rate is lower than planned due to the COVID-19 pandemic and we now anticipate at least a six-month delay in the trial.  However, given our cash runway into Q4 2021, we remain confident in our ability…

    SEATTLE, Aug. 6, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today reported its financial results for the second quarter and six months ended June 30, 2020.

    "This past quarter we announced enrollment of the first patient in our PRE-VENT Phase 3 clinical trial of pacritinib in hospitalized patients with severe COVID-19, an important step for CTI as we work to provide a new therapeutic option for COVID-19 patients," said Adam R. Craig, M.D., Ph.D. "With regards to the PACIFICA Phase 3 trial, we continue to enroll patients but the enrollment rate is lower than planned due to the COVID-19 pandemic and we now anticipate at least a six-month delay in the trial.  However, given our cash runway into Q4 2021, we remain confident in our ability to successfully execute on the development of pacritinib for the treatment of severely thrombocytopenic myelofibrosis patients."

    Second Quarter Financial Results

    Operating loss was $10.0 million and $21.9 million for the three and six months ended June 30, 2020, respectively, compared to operating loss of $11.0 million and $21.5 million for the respective periods in 2019. Operating loss for the three months ended June 30, 2020 as compared to the comparable period in 2019 resulted primarily from a decrease in general and administrative expenses. The increase in operating loss for the six months ended June 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 an increased uncertainty of collectability.

    No revenues were recognized for the three and six months ended June 30, 2020, while revenues of $0.4 million and $1.1 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") related to transition period activities pursuant to the terms of the Termination and Transfer Agreement with Servier.

    Net loss for the three months ended June 30, 2020 was $14.0 million, or $(0.19) for basic and diluted loss per share, compared to net loss of $11.0 million, or $(0.19) for basic and diluted loss per share, for the same period in 2019. Net loss for the six months ended June 30, 2020 was $26.2 million, or $(0.38) for basic and diluted loss per share, compared to net loss of $21.8 million, or $(0.38) for basic and diluted loss per share, for the same period in 2019.

    As of June 30, 2020, cash, cash equivalents and short-term investments totaled $70.1 million, compared to $33.7 million as of December 31, 2019. We expect current cash and cash equivalents will enable us to fund our operations into the fourth quarter of 2021.

    About CTI BioPharma Corp.

    We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. We concentrate our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are focused on evaluating pacritinib, our sole product candidate currently in active development, for the treatment of adult patients with myelofibrosis. In addition, we have recently started developing pacritinib for use in hospitalized patients with severe COVID-19, in response to the COVID-19 pandemic. We are headquartered in Seattle, Washington.

    Forward-Looking Statements

    Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: our ability to conduct and complete clinical trials in our currently anticipated timeframes; our ability to successfully demonstrate the safety and efficacy of pacritinib; our expectations regarding the completion and outcome of our PACIFICA Phase 3 trial and our PRE-VENT Phase 3 trial; the risk that the FDA may determine that the benefit/risk profile of pacritinib at the dose selected for the PACIFICA Phase 3 trial does not support approval; the risk that the FDA may determine that the benefit/risk profile of pacritinib in the PRE-VENT Phase 3 trial does not support approval or requires additional clinical data for approval; the risk that pacritinib may fail in its development through our PACIFICA and PRE-VENT trial; our ability to submit an NDA for pacritinib in the timeline currently anticipated; our ability to receive regulatory approval for pacritinib pursuant to the accelerated approval pathway or at all; the risk that pacritinib may be delayed to a point where it is not commercially viable; the accuracy of our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations; risks and uncertainties related to the COVID-19 pandemic as it relates to our operations and ongoing clinical trials; and those risks more fully discussed in the section entitled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2019 and subsequent quarterly reports on Form 10-Q. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements. "CTI BioPharma" and the CTI BioPharma logo are registered trademarks or trademarks of CTI BioPharma Corp. in various jurisdictions. All other trademarks belong to their respective owner.

    CTI BioPharma Investor Contacts:

    Maeve Conneighton/Maghan Meyers

    +212-600-1902

    (tables follow)

    CTI BioPharma Corp.

    Condensed Consolidated Statements of Operations

    (In thousands, except per share amounts)

    (unaudited)

     



    Three Months Ended

     June 30,



    Six Months Ended

     June 30,



    2020



    2019



    2020



    2019

    License and contract revenues

    $





    $

    416





    $





    $

    1,056



    Operating costs and expenses:















    Research and development

    6,199





    6,356





    9,463





    11,528



    General and administrative

    3,797





    5,053





    8,264





    10,259



    Restructuring expenses













    794



    Other operating expenses









    4,200







    Total operating costs and expenses

    9,996





    11,409





    21,927





    22,581



    Loss from operations

    (9,996)





    (10,993)





    (21,927)





    (21,525)



    Non-operating income (expense):















    Interest income

    43





    347





    162





    727



    Interest expense

    (137)





    (269)





    (304)





    (563)



    Amortization of debt discount and issuance costs

    (130)





    (130)





    (260)





    (260)



    Foreign exchange (loss) gain

    (6)





    69





    (83)





    (169)



    Loss on dissolution of majority-owned subsidiary

    (3,774)









    (3,774)







    Total non-operating (expense) income, net

    (4,004)





    17





    (4,259)





    (265)



    Net loss before noncontrolling interest

    (14,000)





    (10,976)





    (26,186)





    (21,790)



    Noncontrolling interest





    5









    5



    Net loss

    $

    (14,000)





    $

    (10,971)





    $

    (26,186)





    $

    (21,785)



    Basic and diluted net loss per common share

    $

    (0.19)





    $

    (0.19)





    $

    (0.38)





    $

    (0.38)



    Shares used in calculation of basic and diluted net loss per common share:

    73,685





    57,973





    68,073





    57,973



     

    Balance Sheet Data (unaudited):



    (amounts in thousands)





    June 30,



    December 31,





    2020



    2019

    Cash and cash equivalents



    $

    70,110





    $

    31,144



    Short-term investments







    2,522



    Working capital



    57,782





    17,092



    Total assets



    76,412





    46,280



    Current portion of long-term debt



    4,812





    4,812



    Long-term debt, less current portion



    2,049





    4,455



    Total stockholders' equity



    56,863





    17,930



     

    CTI BioPharma Corp. Logo (PRNewsFoto/Cell Therapeutics, Inc.)

     

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  14. SEATTLE, June 1, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced that it has enrolled the first patient in the Phase 3 PRE-VENT trial (NCT04404361) of pacritinib in hospitalized patients with severe COVID-19. PRE-VENT, a randomized, double-blind, placebo-controlled multicenter study, will compare pacritinib plus standard of care versus placebo and standard of care in 358 hospitalized patients with severe COVID-19, including patients with and without cancer. The primary endpoint of the trial will assess the proportion of patients who progress to invasive mechanical ventilation and/or extracorporeal membrane oxygenation or die by Day 28.

    "Initiation of patient enrollment in the PRE-VENT Phase 3 trial is an important step for CTI as we work towards providing a new therapeutic option for patients with severe COVID-19," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "As a multi-kinase inhibitor, pactrinib has the potential to reduce the effects of the cytokine storm that occurs with the novel coronavirus infection, an inflammatory response that frequently leads to respiratory failure and need for mechanical ventilation."

    "Preventing COVID-19 patients from developing the severe inflammatory response that leads to respiratory failure is critical as the medical community works to ameliorate the effects of the ongoing pandemic," said John Mascarenhas, M.D., Associate Professor, Medicine, Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York and Chief Investigator of the PRE-VENT Study. "Because the cytokine storm occurs when multiple inflammatory cytokines are activated, including IL-1 and IL-6, a multi-kinase inhibitor such as pacritinib has the potential to inhibit the inflammatory response and improve patient outcomes."

    Cytokine storm is a pathological immune reaction that can be triggered by viral infection and can lead to serious complications, including acute respiratory distress syndrome (ARDS). Multiple inflammatory cytokines are upregulated in patients with severe COVID-19, including IL-1 and IL-6, and some patients have evidence of over-active macrophage activation. As a JAK2/IRAK-1 inhibitor, pacritinib may ameliorate the effects of cytokine storm via inhibition of IL-6 and IL-1 signaling. Furthermore, as a CSF-1R inhibitor, pacritinib may mitigate effects of macrophage activation syndrome. Of particular importance in this indication, pacritinib has not been associated with increased risk in infections in prior randomized studies, likely because it does not have inhibitory effects on JAK1.

    About PRE-VENT
    PRE-VENT is expected to enroll 358 patients randomized 1:1 to receive pacritinib (400 mg once daily on Day 1, then 200 mg twice daily from Day 2 to Day 14) + SOC or placebo + SOC. Assigned treatment will continue for up to Day 14 or until the patient experiences intolerable adverse events, withdraws consent, initiates another investigational therapy, or until the study is terminated. Assigned therapy may be given for an additional 7 days (for a total of 21 days) at the discretion of the investigator. In the event of hospital discharge, patients will complete treatment with the assigned therapy on an outpatient basis. Severe COVID-19 will be defined as an oxygen saturation (SO2) ≤93% on room air at sea level, respiratory frequency >30 breaths per minute, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300, or lung infiltrates >50% on radiographic imaging.

    The primary endpoint is the effect of treatment on the proportion of patients who require invasive mechanical ventilation and/or extracorporeal membrane oxygenation, or die by Day 28. An interim analysis will be conducted for futility after 154 patients have been enrolled. Safety will be assessed through 30 days of follow-up after the last dose of study treatment and assessed by the cumulative incidence, severity and seriousness of treatment-emergent AEs, drug discontinuations, laboratory values, and clinical assessments.

    Further information on the PRE-VENT study can be found at https://clinicaltrials.gov/ct2/show/NCT04404361?term=NCT04404361&draw=2&rank=1.

    About Pacritinib
    Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, IRAK1 and CSF1R. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukemia and lymphoma. In addition to myelofibrosis, the kinase profile of pacritinib suggests its potential therapeutic utility in inflammatory and immune-mediated disorders such acute graft-versus-host disease (aGVHD) and hemophagocytic lymphohistiocytosis (HLH).

    About CTI BioPharma Corp.
    We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. We concentrate our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are focused on evaluating pacritinib, our sole product candidate currently in active development, for the treatment of adult patients with myelofibrosis. We are headquartered in Seattle, Washington.

    Forward-Looking Statements
    Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: our ability to conduct and complete clinical trials in our currently anticipated timeframes; our ability to successfully demonstrate the safety and efficacy of pacritinib; our expectations regarding the completion and outcome of the PACIFICA Phase 3 trial and the PRE-VENT Phase 3 trial; the risk that the FDA may determine that the benefit/risk profile of pacritinib at the dose selected for the PACIFICA Phase 3 trial does not support approval; the risk that the FDA may determine that the benefit/risk profile of pacritinib in the PRE-VENT Phase 3 trial does not support approval or requires additional clinical data for approval; the risk that pacritinib may fail in development; our ability to submit an NDA for pacritinib in the timeline currently anticipated; our ability to receive regulatory approval for pacritinib pursuant to the accelerated approval pathway or at all; the risk that pacritinib may be delayed to a point where it is not commercially viable; the accuracy of our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations; risks and uncertainties related to the COVID-19 pandemic as it relates to our operations and ongoing clinical trials; and those risks more fully discussed in the section entitled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2019 and subsequent quarterly reports on Form 10-Q. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "CTI BioPharma" and the CTI BioPharma logo are registered trademarks or trademarks of CTI BioPharma Corp. in various jurisdictions. All other trademarks belong to their respective owner.

    CTI BioPharma Investor Contacts:
    Maeve Conneighton/Maghan Meyers
    +212-600-1902

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    SOURCE CTI BioPharma Corp.

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  15. SEATTLE, May 28, 2020 /PRNewswire/ -- CTI BioPharma Corp. (CTI BioPharma) (NASDAQ:CTIC) today announced that management will provide a corporate overview at the Jefferies 2020 Healthcare Conference at 2:30 p.m. EDT. The conference will be held in a virtual meeting format.

    Presentation details:


    Event:

    Jefferies 2020 Healthcare Conference    

    Date:

    Thursday, Jun. 4

    Time:  

    2:30 p.m. EDT

    The presentation will be webcast live and available for replay from the Investors section of CTI BioPharma's website at www.ctibiopharma.com.

    About CTI BioPharma Corp.

    We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit…

    SEATTLE, May 28, 2020 /PRNewswire/ -- CTI BioPharma Corp. (CTI BioPharma) (NASDAQ:CTIC) today announced that management will provide a corporate overview at the Jefferies 2020 Healthcare Conference at 2:30 p.m. EDT. The conference will be held in a virtual meeting format.

    Presentation details:


    Event:

    Jefferies 2020 Healthcare Conference    

    Date:

    Thursday, Jun. 4

    Time:  

    2:30 p.m. EDT

    The presentation will be webcast live and available for replay from the Investors section of CTI BioPharma's website at www.ctibiopharma.com.

    About CTI BioPharma Corp.

    We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. We concentrate our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are focused on evaluating pacritinib, our sole product candidate currently in active development, for the treatment of adult patients with myelofibrosis. We are headquartered in Seattle, Washington.

    CTI BioPharma Investor Contacts:

    Argot Partners
    Maeve Conneighton/Maghan Meyers  
    +1-212-600-1902

    CTI BioPharma Corp. Logo (PRNewsFoto/Cell Therapeutics, Inc.)

     

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    SOURCE CTI BioPharma Corp.

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  16. SEATTLE, May 7, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today reported its financial results for the first quarter ended March 31, 2020.

    "With a sufficient cash runway into Q4 2021, we have the resources to continue to advance pacritinib as quickly as possible as a potential treatment for severely thrombocytopenic myelofibrosis patients through the execution of the ongoing Phase 3 PACIFICA trial," said Adam R. Craig, M.D., Ph.D. "Additionally, in response to the global COVID-19 pandemic, as pacritinib has the potential to reduce the inflammatory response to the infection, which can lead to acute respiratory distress and mechanical ventilation, we recently announced the initiation of PRE-VENT, a Phase 3 double-blind, placebo-controlled…

    SEATTLE, May 7, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today reported its financial results for the first quarter ended March 31, 2020.

    "With a sufficient cash runway into Q4 2021, we have the resources to continue to advance pacritinib as quickly as possible as a potential treatment for severely thrombocytopenic myelofibrosis patients through the execution of the ongoing Phase 3 PACIFICA trial," said Adam R. Craig, M.D., Ph.D. "Additionally, in response to the global COVID-19 pandemic, as pacritinib has the potential to reduce the inflammatory response to the infection, which can lead to acute respiratory distress and mechanical ventilation, we recently announced the initiation of PRE-VENT, a Phase 3 double-blind, placebo-controlled, multicenter study of pacritinib for the treatment of hospitalized patients with severe COVID-19, including patients with and without cancer. We look forward to providing updates on the PRE-VENT trial in the coming months. With regards to the PACIFICA Phase 3 trial timeline, we anticipate at least a three-month delay to enrollment due to the COVID-19 pandemic."

    First Quarter Financial Results

    Operating loss was $11.9 million for the first quarter of 2020, compared to operating loss of $10.5 million for the same period in 2019. The increase in operating loss in the first quarter of 2020 as compared to operating loss in the same period in 2019 resulted primarily from expenses related to provisions for our Italian Value Added Tax receivables due to uncertainty regarding the collectability of such receivables as a result of the recent COVID-19 global pandemic, partially offset by decreases in research and development expenses and restructuring expenses.

    License and contract revenues for the three months ended March 31, 2019 were $0.6 million while no revenues were recognized for the same period in 2020. The decrease is primarily due to royalty and other revenues recognized in 2019 from Les Laboratoires Servier and Institut de Recherches Internationales Servier ("Servier") related to transition period activities pursuant to the terms of the Termination and Transfer Agreement with Servier.

    Net loss attributable to common stockholders for the first quarter of 2020 was $12.2 million, or $(0.20) for basic and diluted loss per share, compared to net loss attributable to common stockholders of $10.8 million, or $(0.19) for basic and diluted loss per share, for the same period in 2019.

    As of March 31, 2020, cash, cash equivalents and short-term investments totaled $81.1 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.

    About CTI BioPharma Corp.

    We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. We concentrate our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are focused on evaluating pacritinib, our sole product candidate currently in active development, for the treatment of adult patients with myelofibrosis. We are headquartered in Seattle, Washington.

    Forward-Looking Statements

    Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: our ability to conduct and complete clinical trials in our currently anticipated timeframes; our ability to successfully demonstrate the safety and efficacy of pacritinib; our expectations regarding the completion and outcome of the PACIFICA Phase 3 trial and the PRE-VENT Phase 3 trial; the risk that the FDA may determine that the benefit/risk profile of pacritinib at the dose selected for the PACIFICA Phase 3 trial does not support approval; the risk that the FDA may determine that the benefit/risk profile of pacritinib in the PRE-VENT Phase 3 trial does not support approval or requires additional clinical data for approval; the risk that pacritinib may fail in development; our ability to submit an NDA for pacritinib in the timeline currently anticipated; our ability to receive regulatory approval for pacritinib pursuant to the accelerated approval pathway or at all; the risk that pacritinib may be delayed to a point where it is not commercially viable; the accuracy of our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations; risks and uncertainties related to the COVID-19 pandemic as it relates to our operations and ongoing clinical trials; and those risks more fully discussed in the section entitled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2019 and subsequent quarterly reports on Form 10-Q. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "CTI BioPharma" and the CTI BioPharma logo are registered trademarks or trademarks of CTI BioPharma Corp. in various jurisdictions. All other trademarks belong to their respective owner.

    CTI BioPharma Investor Contacts:
    Maeve Conneighton/Maghan Meyers
    +212-600-1902

    (tables follow)

     

    CTI BioPharma Corp.

    Condensed Consolidated Statements of Operations

    (In thousands, except per share amounts)

    (unaudited)


    Three Months Ended

     March 31,


    2020


    2019

    License and contract revenues

    $



    $

    640


    Operating costs and expenses:




    Research and development

    3,264



    5,172


    General and administrative

    4,467



    5,206


    Restructuring expenses



    794


    Other operating expenses

    4,200




    Total operating costs and expenses

    11,931



    11,172


    Loss from operations

    (11,931)



    (10,532)


    Non-operating income (expense):




    Interest income

    119



    380


    Interest expense

    (167)



    (294)


    Amortization of debt discount and issuance costs

    (130)



    (130)


    Foreign exchange loss

    (77)



    (238)


    Total non-operating expense, net

    (255)



    (282)


    Net loss

    $

    (12,186)



    $

    (10,814)


    Basic and diluted net loss per common share

    $

    (0.20)



    $

    (0.19)


    Shares used in calculation of basic and diluted net loss per common share:

    62,461



    57,973


     

    Balance Sheet Data (unaudited):


    (amounts in thousands)



    March 31,


    December 31,



    2020


    2019

    Cash and cash equivalents


    $

    81,149



    $

    31,144


    Short-term investments




    2,522


    Working capital


    68,234



    17,092


    Total assets


    87,981



    46,280


    Current portion of long-term debt


    4,812



    4,812


    Long-term debt, less current portion


    3,252



    4,455


    Total stockholders' equity


    22,384



    17,930


     

    CTI BioPharma Corp. Logo (PRNewsFoto/Cell Therapeutics, Inc.)

     

     

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  17. SEATTLE, April 27, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced the initiation of PRE-VENT, a Phase 3 study evaluating pacritinib in hospitalized patients with severe COVID-19. PRE-VENT, a randomized, double-blind, placebo-controlled multicenter study, will compare pacritinib plus standard of care (SOC) versus placebo plus standard of care in 358 hospitalized patients with severe COVID-19, including patients with and without cancer. The primary endpoint of the trial will assess the proportion of patients who progress to invasive mechanical ventilation and/or extracorporeal membrane oxygenation or die by Day 28. CTI expects to commence enrollment of PRE-VENT in May at sites in the United States and in Europe with data…

    SEATTLE, April 27, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced the initiation of PRE-VENT, a Phase 3 study evaluating pacritinib in hospitalized patients with severe COVID-19. PRE-VENT, a randomized, double-blind, placebo-controlled multicenter study, will compare pacritinib plus standard of care (SOC) versus placebo plus standard of care in 358 hospitalized patients with severe COVID-19, including patients with and without cancer. The primary endpoint of the trial will assess the proportion of patients who progress to invasive mechanical ventilation and/or extracorporeal membrane oxygenation or die by Day 28. CTI expects to commence enrollment of PRE-VENT in May at sites in the United States and in Europe with data expected by the end of 2020.

    "Patients with severe COVID-19, particularly those with cancer, are at high risk for serious complications from the disease stemming from cytokine storm, an inflammatory response that causes white blood cells to not only fight the viral infection, but also damage tissue, primarily in the lungs," said John Mascarenhas, M.D., Associate Professor, Medicine, Hematology and Medical Oncology, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York and Chief Investigator of the PRE-VENT Study. "Because pacritinib inhibits JAK2, IRAK-1 and CSF1R, there is real potential for pacritinib to prevent patients from developing an inflammatory response to the coronavirus infection and subsequent pulmonary failure, therefore reducing the need for a ventilator."

    "Given the unprecedented medical need to improve outcomes for patients with COVID-19, we have made a commitment to test pacritinib, a JAK2/IRAK-1/CSF-1R inhibitor, in hospitalized patients with severe COVID-19, with the goal of preventing progression to acute respiratory distress syndrome and mechanical ventilation," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. "Emerging evidence suggests that the attenuation of the cytokine storm associated with COVID-19 could be a potential treatment approach for this devastating disease, and it is hypothesized that pacritinib may have a role in treating these patients. We would like to thank the FDA for their expedited review of the PRE-VENT protocol. Enrollment is expected to commence in the coming weeks. With ample supply of pacritinib available, we continue to recruit patients on the pivotal Phase 3 PACIFICA trial of pacrtitnib in myelofibrosis patients with severe thrombocytopenia."

    Cytokine storm is a pathological immune reaction that can be triggered by viral infection and can lead to serious complications, including acute respiratory distress syndrome (ARDS). Multiple inflammatory cytokines are upregulated in patients with severe COVID-19, including IL-1 and IL-6, and some patients have evidence of over-active macrophage activation. As a JAK2/IRAK-1 inhibitor, pacritinib may ameliorate the effects of cytokine storm via inhibition of IL-6 and IL-1 signaling. Furthermore, as a CSF-1R inhibitor, pacritinib may mitigate effects of macrophage activation syndrome. Of particular importance in this indication, pacritinib has not been associated with increased risk in infections in prior randomized studies, likely because it does not have inhibitory effects on JAK1. 

    About PRE-VENT
    PRE-VENT is expected to enroll 358 patients randomized 1:1 to receive pacritinib (400 mg once daily on Day 1, then 200 mg twice daily from Day 2 to Day 14) + SOC or placebo + SOC. Assigned treatment will continue for up to Day 14 or until the patient experiences intolerable adverse events, withdraws consent, initiates another investigational therapy, or until the study is terminated. Assigned therapy may be given for an additional 7 days (for a total of 21 days) at the discretion of the investigator. In the event of hospital discharge, patients will complete treatment with the assigned therapy as an outpatient. Severe COVID-19 will be defined as an oxygen saturation (SO2) ≤93% on room air at sea level, respiratory frequency >30 breaths per minute, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300, or lung infiltrates >50% on radiographic imaging.

    The primary endpoint is the effect of treatment on the proportion of patients who require invasive mechanical ventilation and/or extracorporeal membrane oxygenation, or die by Day 28. An interim analysis will be conducted for futility after 154 patients have been enrolled. Safety will be assessed through 30 days of follow-up after the last dose of study treatment and assessed by the cumulative incidence, severity and seriousness of treatment-emergent AEs, drug discontinuations, laboratory values, and clinical assessments.

    About Pacritinib
    Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, IRAK1 and CSF1R. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukemia and lymphoma. In addition to myelofibrosis, the kinase profile of pacritinib suggests its potential therapeutic utility in inflammatory and immune-mediated disorders such acute graft-versus-host disease (aGVHD) and hemophagocytic lymphohistiocytosis (HLH).

    About CTI BioPharma Corp.
    We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. We concentrate our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are focused on evaluating pacritinib, our sole product candidate currently in active development, for the treatment of adult patients with myelofibrosis. We are headquartered in Seattle, Washington.

    Forward-Looking Statements
    Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: our ability to conduct and complete clinical trials in our currently anticipated timeframes; our ability to successfully demonstrate the safety and efficacy of pacritinib, including in COVID-19 patients; our expectations regarding the completion and outcome of the PACIFICA Phase 3 trial and the PRE-VENT Phase 3 trial; the risk that the FDA may determine that the benefit/risk profile of pacritinib at the dose selected for the PACIFICA Phase 3 trial does not support approval; the risk that the FDA may determine that the benefit/risk profile of pacritinib in the PRE-VENT Phase 3 trial does not support approval or requires additional clinical data for approval; the risk that pacritinib may fail in development; our ability to submit an NDA for pacritinib in the timeline currently anticipated; our ability to receive regulatory approval for pacritinib pursuant to the accelerated approval pathway or at all; the risk that pacritinib may be delayed to a point where it is not commercially viable; the accuracy of our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations; riks and uncertainties related to the COVID-19 pandemic as it relates to our operations and ongoing clinical trials; and those risks more fully discussed in the section entitled "Risk Factors" in our Annual Report on Form 10-K for the year ended December 31, 2019. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "CTI BioPharma" and the CTI BioPharma logo are registered trademarks or trademarks of CTI BioPharma Corp. in various jurisdictions. All other trademarks belong to their respective owner.

    CTI BioPharma Investor Contacts:
    Maeve Conneighton/Maghan Meyers
    +212-600-1902

    CTI BioPharma Corp. Logo (PRNewsFoto/Cell Therapeutics, Inc.)

     

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    SOURCE CTI BioPharma Corp.

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  18. SEATTLE, April 8, 2020 /PRNewswire/ -- CTI BioPharma Corp. (CTI BioPharma) (NASDAQ:CTIC) today announced that management will provide a corporate overview at the Needham Healthcare Conference at 10:40 a.m. EDT. The conference will be held in a virtual meeting format.

    Presentation details:



    Event:       

    Needham Healthcare Conference   

    Date:         

    Wednesday, Apr. 15

    Time:        

    10:40 a.m. EDT

    The presentation will be webcast live and available for replay from the Investors section of CTI BioPharma's website at www.ctibiopharma.com.

    About CTI BioPharma Corp.

    We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to…

    SEATTLE, April 8, 2020 /PRNewswire/ -- CTI BioPharma Corp. (CTI BioPharma) (NASDAQ:CTIC) today announced that management will provide a corporate overview at the Needham Healthcare Conference at 10:40 a.m. EDT. The conference will be held in a virtual meeting format.

    Presentation details:





    Event:       

    Needham Healthcare Conference   

    Date:         

    Wednesday, Apr. 15

    Time:        

    10:40 a.m. EDT

    The presentation will be webcast live and available for replay from the Investors section of CTI BioPharma's website at www.ctibiopharma.com.

    About CTI BioPharma Corp.

    We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. We concentrate our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are focused on evaluating pacritinib, our sole product candidate currently in active development, for the treatment of adult patients with myelofibrosis. We are headquartered in Seattle, Washington.

    CTI BioPharma Investor Contacts:

    Argot Partners

    Maeve Conneighton/Maghan Meyers  

    +1-212-600-1902

    CTI BioPharma Corp. Logo (PRNewsFoto/Cell Therapeutics, Inc.)

     

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    SOURCE CTI BioPharma Corp.

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  19. SEATTLE, March 12, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today reported its financial results for the fourth quarter and full year ended December 31, 2019.

    "In the latter half of 2019 and beginning of 2020, we further advanced our pacritinib development program, including presenting data at the American Society of Hematology Annual Meeting that reinforced the clinical and scientific rationale for our ongoing PAC203 Phase 3 PACIFICA trial evaluating pacritinib at 200 mg BID in severely thrombocytopenic myelofibrosis patients," said Adam R. Craig, M.D., Ph.D. "Severely thrombocytopenic myelofibrosis patients have limited, and often ineffective, therapeutic options. In an effort to advance pacritinib as quickly as possible to these…

    SEATTLE, March 12, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today reported its financial results for the fourth quarter and full year ended December 31, 2019.

    "In the latter half of 2019 and beginning of 2020, we further advanced our pacritinib development program, including presenting data at the American Society of Hematology Annual Meeting that reinforced the clinical and scientific rationale for our ongoing PAC203 Phase 3 PACIFICA trial evaluating pacritinib at 200 mg BID in severely thrombocytopenic myelofibrosis patients," said Adam R. Craig, M.D., Ph.D. "Severely thrombocytopenic myelofibrosis patients have limited, and often ineffective, therapeutic options. In an effort to advance pacritinib as quickly as possible to these patients, we established an accelerated approval pathway with the U.S. Food and Drug Administration ("FDA") by amending the PACIFICA pivotal Phase 3 trial protocol to allow for the primary analysis of Spleen Volume Reduction ("SVR") rates on the first 168 patients, with an end-of-study analysis of Total Symptom Score ("TSS") and Overall Survival ("OS") following the full enrollment of 348 patients. If the primary endpoint of SVR is met following the planned review of data from the first 168 patients, we intend to submit a New Drug Application ("NDA") under the FDA's subpart H regulations. We expect to report primary SVR data by the end of 2021, with a potential NDA filing in early 2022. Additionally, we recently raised an additional $59.3 million in a rights offering, which provides us with additional cash runway into Q1 2022 as we continue to develop pacritinib."

    Fourth Quarter Financial Results
    Operating loss was $9.5 million and $40.7 million for the three months and year ended December 31, 2019, respectively, compared to operating income of $0.2 million and operating loss of $32.9 million for the respective periods in 2018. The operating loss during the three-month period ended December 31, 2019 as compared to the operating income for the comparable period in 2018 resulted primarily from the decrease in license and contract revenue as discussed below, partially offset by a decrease in operating expenses. The increase in operating loss for the year ended December 31, 2019 as compared to the same period in 2018 resulted primarily from a decrease in license and contract revenues between periods as discussed below, partially offset by a decrease in operating expenses. As of December 31, 2019, cash, cash equivalents and short-term investments totaled $33.7 million, compared to $67.0 million as of December 31, 2018. In March 2020, we completed our rights offering and received approximately $59.3 million in net proceeds. We expect current cash, cash equivalents and short-term investments, when combined with the net proceeds we received from the rights offering, will enable us to fund our operations into the first quarter of 2022.

    License and contract revenues for the three months ended December 31, 2018 were $14.1 million while no revenues were recognized during the three months ended December 31, 2019. License and contract revenues for the three months ended December 31, 2018 were primarily related to milestone revenues recognized upon the achievement of a regulatory milestone under the license and collaboration agreement for PIXUVRI® with Les Laboratoires Servier and Institut de Recherches Internationales Servier as well as the attainment of a worldwide net sales milestone of TRISENOX® (arsenic trioxide) under the agreement with Teva Pharmaceutical Industries Ltd. ("Teva"). License and contract revenues for the years ended December 31, 2019 and 2018 were $3.3 million and $26.3 million, respectively. The decrease between periods primarily resulted from milestone revenues recognized in 2018 from Teva related to the achievement of a milestone for FDA approval of TRISENOX for first-line treatment of acute promyelocytic leukemia, in addition to the license and contract revenues recognized during the three months ended December 31, 2018, as discussed above.

    Net loss attributable to common stockholders for the three months ended December 31, 2019 was $8.2 million, or $(0.14) for basic and diluted loss per share, compared to net income attributable to common stockholders of $0.8 million, or $0.01 for basic and diluted income per share, for the same period in 2018. Net loss attributable to common stockholders for the year ended December 31, 2019 was $40.0 million, or $(0.69) for basic and diluted loss per share, compared to net loss attributable to common stockholders of $29.4 million, or $(0.52) for basic and diluted loss per share, for the same period in 2018.

    About CTI BioPharma Corp.
    We are a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. We concentrate our efforts on treatments that target blood-related cancers where there is an unmet medical need. In particular, we are focused on evaluating pacritinib, our sole product candidate currently in active development, for the treatment of adult patients with myelofibrosis. We are headquartered in Seattle, Washington.

    Forward-Looking Statements
    Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: our ability to conduct and complete clinical trials in our currently anticipated timeframes; our ability to successfully demonstrate the safety and efficacy of pacritinib; our expectations regarding the completion and outcome of the PACIFICA Phase 3 trial; the risk that the FDA may determine that the benefit/risk profile of pacritinib at the dose selected for the PACIFICA Phase 3 trial does not support approval; the risk that pacritinib may fail in development; our ability to submit an NDA for pacritinib in the timeline currently anticipated; our ability to receive regulatory approval for pacritinib pursuant to the accelerated approval pathway or at all; the risk that pacritinib may be delayed to a point where it is not commercially viable; the accuracy of our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations; and those risks more fully discussed in the section entitled "Risk Factors" in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2019. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "CTI BioPharma" and the CTI BioPharma logo are registered trademarks or trademarks of CTI BioPharma Corp. in various jurisdictions. All other trademarks belong to their respective owner.

    CTI BioPharma Investor Contacts:
    Maeve Conneighton/Maghan Meyers
    +212-600-1902

    (tables follow)

    CTI BioPharma Corp.

    Condensed Consolidated Statements of Operations

    (In thousands, except per share amounts)

    (unaudited)



    Three Months Ended

     December 31,


    Twelve Months Ended

     December 31,


    2019


    2018


    2019


    2018

    License and contract revenues

    $



    $

    14,108



    $

    3,345



    $

    26,290


    Operating costs and expenses:








    Research and development

    4,981



    7,928



    24,107



    36,467


    Selling, general and administrative

    4,493



    5,312



    19,155



    22,062


    Restructuring expenses



    660



    794



    660


    Total operating costs and expenses

    9,474



    13,900



    44,056



    59,189


    (Loss) income from operations

    (9,474)



    208



    (40,711)



    (32,899)


    Non-operating income (expense):








    Interest income

    169



    419



    1,172



    1,219


    Interest expense

    (199)



    (316)



    (1,002)



    (1,209)


    Amortization of debt discount and issuance costs

    (130)



    (131)



    (521)



    (525)


    Foreign exchange gain (loss)

    128



    665



    (281)



    (233)


    Other non-operating income

    1,320





    1,320



    4,295


    Total non-operating income, net

    1,288



    637



    688



    3,547


    Net (loss) income before noncontrolling interest

    (8,186)



    845



    (40,023)



    (29,352)


    Noncontrolling interest

    (2)



    1



    3



    32


    Net (loss) income

    (8,188)



    846



    (40,020)



    (29,320)


    Deemed dividends on preferred stock







    (80)


    Net (loss) income attributable to common stockholders

    $

    (8,188)



    $

    846



    $

    (40,020)



    $

    (29,400)


    Net (loss) income per common share:








        Basic

    $

    (0.14)



    $

    0.01



    $

    (0.69)



    $

    (0.52)


        Diluted

    $

    (0.14)



    $

    0.01



    $

    (0.69)



    $

    (0.52)


    Shares used in calculation of (loss) income per common share:








        Basic

    57,974



    57,969



    57,974



    56,073


        Diluted

    57,974



    57,970



    57,974



    56,073


     

    Balance Sheet Data (unaudited):


    (amounts in thousands)



    December 31,


    December 31,



    2019


    2018

    Cash and cash equivalents


    $

    31,144



    $

    36,439


    Short-term investments


    2,522



    30,599


    Working capital


    17,092



    59,437


    Total assets


    46,280



    89,832


    Current portion of long-term debt


    4,812



    4,812


    Long-term debt, less current portion


    4,455



    9,267


    Total stockholders' equity


    17,930



    52,939


     

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  20. SEATTLE, March 6, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced the closing of its previously announced rights offering (the "Rights Offering").  At the closing, CTI BioPharma sold and issued an aggregate of 15,698,995 shares of its common stock (the "Common Stock") and an aggregate of 4,429.2423 shares of its series X convertible preferred stock (the "Series X Preferred") pursuant to the exercise of subscription rights and Oversubscription Rights in the Rights Offering by existing holders of CTI Biopharma's Common Stock and series O convertible preferred stock. The Rights Offering was fully backstopped by certain existing stockholders of CTI BioPharma who agreed to purchase any shares of Common Stock and/or Series X…

    SEATTLE, March 6, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced the closing of its previously announced rights offering (the "Rights Offering").  At the closing, CTI BioPharma sold and issued an aggregate of 15,698,995 shares of its common stock (the "Common Stock") and an aggregate of 4,429.2423 shares of its series X convertible preferred stock (the "Series X Preferred") pursuant to the exercise of subscription rights and Oversubscription Rights in the Rights Offering by existing holders of CTI Biopharma's Common Stock and series O convertible preferred stock. The Rights Offering was fully backstopped by certain existing stockholders of CTI BioPharma who agreed to purchase any shares of Common Stock and/or Series X Preferred offered in the Rights Offering that were not subscribed for (the "Oversubscription Rights"). CTI BioPharma raised aggregate gross proceeds of approximately $60.0 million in the Rights Offering.

    Of the total shares of Common Stock and Series X Preferred sold and issued in the Rights Offering, certain affiliates of BVF Partners L.P. purchased 3,047 shares of Series X Preferred, Stonepine Capital, LP purchased 3,267,127 shares of Common Stock and 673.2873 shares of Series X Preferred, OrbiMed Private Investments VI, LP purchased 4,520,600 shares of Common Stock and 298 shares of Series X Preferred and New Enterprise Associates, Inc. purchased 3,390,450 shares of Common Stock and 410.955 shares of Series X Preferred, in each case, pursuant to the exercise of their subscription rights and Oversubscription Rights.

    The Rights Offering was made pursuant to CTI BioPharma's effective shelf registration statement on file with the Securities and Exchange Commission (the "SEC") and a prospectus supplement and accompanying prospectus filed with the SEC on February 14, 2020.

    JMP Securities served as financial advisor to CTI BioPharma in connection with the Rights Offering.

    About CTI BioPharma Corp.

    CTI BioPharma Corp. is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. In particular, CTI BioPharma is focused on evaluating pacritinib for the treatment of adult patients with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington.

    "CTI BioPharma" and the CTI BioPharma logo are registered trademarks or trademarks of CTI BioPharma Corp. in various jurisdictions. All other trademarks belong to their respective owner.

    CTI BioPharma Investor Contacts:
    Maeve Conneighton/Maghan Meyers
    +212-600-1902

    CTI BioPharma Corp. Logo (PRNewsFoto/Cell Therapeutics, Inc.)

     

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  21. SEATTLE, Feb. 14, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today commenced its previously announced rights offering to raise gross proceeds of approximately $60.0 million (the "Rights Offering"). Under the terms of the Rights Offering, the holders, as of 5:00 p.m., New York time, on February 13, 2020, of CTI BioPharma's common stock (the "Common Stock") and series O convertible preferred stock (the "Series O Preferred"), are entitled to exercise their subscription rights to purchase their pro rata share (assuming full conversion of the Series O Preferred into shares of Common Stock) of the $60.0 million offering amount, as more fully described in the prospectus supplement (and accompanying prospectus), dated February 14, 2020

    SEATTLE, Feb. 14, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today commenced its previously announced rights offering to raise gross proceeds of approximately $60.0 million (the "Rights Offering"). Under the terms of the Rights Offering, the holders, as of 5:00 p.m., New York time, on February 13, 2020, of CTI BioPharma's common stock (the "Common Stock") and series O convertible preferred stock (the "Series O Preferred"), are entitled to exercise their subscription rights to purchase their pro rata share (assuming full conversion of the Series O Preferred into shares of Common Stock) of the $60.0 million offering amount, as more fully described in the prospectus supplement (and accompanying prospectus), dated February 14, 2020, relating to the Rights Offering (the "Prospectus"). Each subscription right may be exercised to purchase a share of Common Stock at a subscription price equal to $1.00 per share of Common Stock or, in lieu of Common Stock, an equivalent number of shares of non-voting series X convertible preferred stock (the "Series X Preferred") at a purchase price equal to $10,000 per share of Series X Preferred. The subscription rights may be exercised at any time during the subscription period of February 14, 2020 through 5:00 p.m., New York time, on March 2, 2020.

    The Rights Offering will be fully backstopped by BVF Partners L.P., Stonepine Capital, L.P., OrbiMed Private Investments VI, LP and New Enterprise Associates, Inc. (the "Backstop Investors") each of which have agreed to purchase its respective as-converted pro rata share of the offering amount, plus an additional amount of Common Stock or Series X Preferred that are not subscribed for by other purchasers in the Rights Offering, for a total of up to $60.0 million.

    CTI BioPharma reserves the right to modify, extend, postpone or cancel the Rights Offering at any time prior to the closing of the sale of the securities offered in the Rights Offering. CTI BioPharma has engaged Georgeson LLC to act as information agent with respect to the Rights Offering. For questions regarding the Rights Offering, or to obtain copies of the Prospectus and any related materials, please contact Georgeson LLC by telephone at 888-613-9988.

    CTI BioPharma has filed a shelf registration statement (including a prospectus supplement) with the Securities and Exchange Commission (the "SEC").  Before you invest, you should read the Prospectus and the other documents CTI BioPharma has filed with the SEC for more complete information about CTI BioPharma and the Rights Offering. This press release is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities in any jurisdiction, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

    About CTI BioPharma Corp.
    CTI BioPharma Corp. is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. In particular, we are focused on evaluating pacritinib for the treatment of adult patients with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington.

    Forward-Looking Statements
    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding our expectations regarding plans, amounts and timing for the Rights Offering, the purchase of unsubscribed securities by the Backstop Investors and expectations regarding participation in the Rights Offering.

    Risks Related to Forward-Looking Statements
    The forward-looking statements contained in this press release are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to risks identified in our filings with the SEC. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "CTI BioPharma" and the CTI BioPharma logo are registered trademarks or trademarks of CTI BioPharma Corp. in various jurisdictions. All other trademarks belong to their respective owner.

    CTI BioPharma Investor Contacts:
    Maeve Conneighton/Maghan Meyers
    +212-600-1902

    CTI BioPharma Corp. Logo (PRNewsFoto/Cell Therapeutics, Inc.)

     

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  22. SEATTLE, Feb. 3, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced its intent to raise $60 million through a fully backstopped rights offering. Under the terms of the rights offering, investors as of February 13, 2020 in CTI BioPharma's common stock and preferred stock will receive a subscription right entitling them to purchase their pro rata share of the $60 million offering amount. The rights offering will be fully backstopped by BVF Partners L.P., Stonepine Capital, L.P., OrbiMed Private Investments VI, LP and New Enterprise Associates, Inc. each of which have agreed to purchase, at a minimum, its respective as-converted pro rata share of the offering amount, plus an additional amount of securities that are not subscribed…

    SEATTLE, Feb. 3, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced its intent to raise $60 million through a fully backstopped rights offering. Under the terms of the rights offering, investors as of February 13, 2020 in CTI BioPharma's common stock and preferred stock will receive a subscription right entitling them to purchase their pro rata share of the $60 million offering amount. The rights offering will be fully backstopped by BVF Partners L.P., Stonepine Capital, L.P., OrbiMed Private Investments VI, LP and New Enterprise Associates, Inc. each of which have agreed to purchase, at a minimum, its respective as-converted pro rata share of the offering amount, plus an additional amount of securities that are not subscribed for by other purchasers in the rights offering, for a total of up to $60 million.

    Under the proposed rights offering (the "Rights Offering"), CTI BioPharma plans to distribute non-transferable subscription rights to purchase a portion of a share of CTI BioPharma's common stock ("Common Stock") or series X convertible preferred stock ("Series X Preferred") to each stockholder of record of Common Stock, including Common Stock issuable upon conversion of the outstanding shares of CTI Biopharma's series O convertible preferred stock ("Series O Preferred") at $1.00 per share to such security holders of record as of the close of business on February 13, 2020 (the "Record Date"). The subscription rights will be exercisable for shares of Common Stock (or an equivalent number of Series X Preferred), with participation to be allocated among holders of its Common Stock and Series O Preferred on a pro rata basis (assuming full conversion of the Series O Preferred into shares of Common Stock), subject to the aggregate offering threshold and ownership limitations. The subscription rights may be exercised only during the anticipated subscription period of Friday, February 14, 2020, through 5:00 PM (Eastern Time) on Monday, March 2, 2020, unless extended. Any participant in the Rights Offering that, by exercise of its subscription right would become a holder of greater than 9.9% of the outstanding number of shares of Common Stock following the Rights Offering may elect to instead purchase Series X Preferred. CTI BioPharma intends to sell the Series X Preferred at $10,000 per share, and any such holder so electing would have a right to purchase one 10,000th of a share of Series X Preferred for each share of Common Stock it had a right to purchase under the subscription rights. Each share of Series X Preferred is, subject to certain limitations, convertible into 10,000 shares of Common Stock at the election of the holder. The Series X Preferred generally have no voting rights, except as required by law, and will participate pari passu, on an as-converted basis, with any distribution of proceeds to holders of Common Stock and Series O Preferred in the event of CTI BioPharma's liquidation, dissolution or winding up.

    The Rights Offering will be made pursuant to CTI BioPharma's effective shelf registration statement on file with the Securities and Exchange Commission and only by means of a prospectus supplement and accompanying prospectus. CTI BioPharma expects to mail subscription certificates evidencing the subscription rights and a copy of the prospectus supplement and accompanying prospectus for the Rights Offering shortly following the Record Date.

    This press release is not intended to and does not constitute an offer to sell or the solicitation of an offer to subscribe for or buy or an invitation to purchase or subscribe for any securities in any jurisdiction, nor shall there be any sale, issuance or transfer of securities in any jurisdiction in contravention of applicable law. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.

    Certain existing shareholders of CTI BioPharma (the "Investors"), including BVF Partners L.P., CTI BioPharma's largest shareholder, currently owning approximately 11.95% of CTI BioPharma's outstanding Common Stock (and 23.1% on an as-converted basis), Stonepine Capital, L.P., OrbiMed Private Investments VI, LP and New Enterprise Associates, Inc. currently owning 6.23%, 8.62% and 5.59% of CTI BioPharma's outstanding Common Stock, respectively, will backstop the Rights Offering and have agreed to purchase up to $60 million of Common Stock at a subscription price per share of $1.00 (or Series X Preferred at a price of $10,000 per share) in a private placement promptly at the conclusion of the Rights Offering, with the dollar amount to be purchased in such private placement reduced by the dollar amount sold by CTI BioPharma (including to the Investors and their respective affiliates) in the Rights Offering.

    Concurrent with this press release, CTI is announcing the outcome of its recent meeting with the U.S. Food and Drug Administration and the subsequent amendment to the PACIFICA trial. For further details, see the concurrent press release relating to this meeting.

    About CTI BioPharma Corp.
    CTI BioPharma Corp. is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. In particular, we are focused on evaluating pacritinib for the treatment of adult patients with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington.

    Forward-Looking Statements
    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding our expectations regarding plans, amounts and timing for the Rights Offering and the private placement to the Investors, future financing opportunities, the anticipated use of proceeds derived therefrom and expectations regarding participation in the Rights Offering.

    Risks Related to Forward-Looking Statements
    The forward-looking statements contained in this press release are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "CTI BioPharma" and the CTI BioPharma logo are registered trademarks or trademarks of CTI BioPharma Corp. in various jurisdictions. All other trademarks belong to their respective owner.

    CTI BioPharma Investor Contacts:
    Maeve Conneighton/Maghan Meyers
    +212-600-1902

    CTI BioPharma Corp. Logo (PRNewsFoto/Cell Therapeutics, Inc.)

     

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  23. SEATTLE, Feb. 3, 2020 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced that following a meeting with the U.S. Food and Drug Administration ("FDA" or "the Agency"), CTI has reached agreement on an accelerated approval pathway for pacritinib for the treatment of myelofibrosis patients with severe thrombocytopenia (platelet counts <50,000/µL).  CTI will be amending the PACIFICA pivotal Phase 3 trial protocol to allow for the primary analysis of SVR rates on the first 168 patients, with an end-of-study analysis of TSS and OS following the full enrollment of 348 patients. If the primary endpoint of SVR is met following the planned review of data from the first 168 patients, CTI intends to submit a New Drug Application (NDA) under the FDA's subpart H regulations, subject to review of all available efficacy and safety data. Conversion to a regular approval of pacritinib would be anticipated following the successful end-of-study assessment of the secondary efficacy endpoints, and the completion of post-marketing requirements.

    CTI BioPharma Corp. Logo (PRNewsFoto/Cell Therapeutics, Inc.)

    "Since the initiation of the PACIFICA trial in September 2019, we have been working diligently with the FDA to identify an expedited approval pathway for pacritinib for the treatment of myelofibrosis patients with severe thrombocytopenia," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI Biopharma. "Severely thrombocytopenic myelofibrosis patients (platelet counts <50,000/µL) have reduced survival and very limited therapeutic options. Pacritinib has now demonstrated clinical benefit in this population in three clinical trials, including two prior randomized Phase 3 studies, so we believe that pacritinib has the potential to change the treatment paradigm in this area of serious unmet medical need."

    Based on the new trial design, CTI expects to report primary SVR data by the end of 2021, with a potential NDA filing in early 2022 if the SVR data is positive. Final study efficacy data is expected in 2023.

    Concurrent with this press release, CTI is announcing a $60 million rights offering. For further details, see the concurrent press release relating to the rights offering.

    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 anemia, weakness, fatigue and an 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. 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. There are currently no approved therapies available to treat myelofibrosis patients with severe thrombocytopenia or patients who have failed ruxolitinib treatment, thereby making this a significant unmet medical need.

    About Pacritinib
    Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukemia and lymphoma. In addition to myelofibrosis, the kinase profile of pacritinib suggests its potential therapeutic utility in conditions such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), and chronic lymphocytic leukemia (CLL), due to its inhibition of c-fms, IRAK1, JAK2 and FLT3.

    About CTI BioPharma Corp.
    CTI BioPharma Corp. is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. In particular, we are focused on evaluating pacritinib for the treatment of adult patients with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington.

    Forward-Looking Statements
    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding our expectations regarding: the anticipated trial design of the PACIFICA Phase 3 trial, including changes to the protocol as discussed in this press release; the anticipated enrollment of the PACIFICA Phase 3 trial; the effectiveness of, and potential changes to, the PACIFICA Phase 3 trial design; the timing of, and results from, clinical trials and other development activities related to pacritinib, including the PACIFICA Phase 3 trial and its related protocol; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of pacritinib; the anticipated timing of regulatory submissions and interactions, including any potential NDA submission; our ability to expedite the regulatory approval process; our ability to successfully develop and achieve milestones in the development of pacritinib; and the anticipated benefits of pacritinib.

    Risks Related to Forward-Looking Statements
    The forward-looking statements contained in this press release are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of pacritinib; the FDA may determine that the benefit/risk profile of pacritinib at the dose selected for the PACIFICA Phase 3 trial does not support approval based on the results of such trial, previously identified FDA concerns regarding safety and dosing limitations or otherwise; pacritinib may fail in development, may not receive required regulatory approvals, or may be delayed to a point where it is not commercially viable; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; we may not achieve additional milestones in our pacritinib development program; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "CTI BioPharma" and the CTI BioPharma logo are registered trademarks or trademarks of CTI BioPharma Corp. in various jurisdictions. All other trademarks belong to their respective owner.

    CTI BioPharma Investor Contacts:
    Maeve Conneighton/Maghan Meyers
    +212-600-1902

     

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    SOURCE CTI BioPharma Corp.

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  24. SEATTLE, Dec. 9, 2019 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced the presentation of data from the Company's pacritinib development program, including results from the PAC203 Phase 2 clinical trial, at the 61st American Society of Hematology (ASH) Annual Meeting being held December 7-10 in Orlando, Florida.

    "The data presented at ASH underscore the clinical and scientific rationale for our ongoing PAC203 Phase 3 PACIFICA trial evaluating pacritinib at 200 mg BID in severely thrombocytopenic myelofibrosis patients," said Adam R. Craig, M.D., Ph.D. "Pacritinib has now been demonstrated to provide clinical benefit in treating severely thrombocytopenic myelofibrosis (platelet counts less than 50,000 per microliter) in three

    SEATTLE, Dec. 9, 2019 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced the presentation of data from the Company's pacritinib development program, including results from the PAC203 Phase 2 clinical trial, at the 61st American Society of Hematology (ASH) Annual Meeting being held December 7-10 in Orlando, Florida.

    "The data presented at ASH underscore the clinical and scientific rationale for our ongoing PAC203 Phase 3 PACIFICA trial evaluating pacritinib at 200 mg BID in severely thrombocytopenic myelofibrosis patients," said Adam R. Craig, M.D., Ph.D. "Pacritinib has now been demonstrated to provide clinical benefit in treating severely thrombocytopenic myelofibrosis (platelet counts less than 50,000 per microliter) in three clinical trials, including two prior randomized Phase 3 studies. Further, the PAC203 Phase 2 results from the 200 mg BID cohort demonstrate a favorable risk-benefit profile for pacritinib when treating patients with advanced disease that have high mutational risk and long durations of prior ruxolitinib exposure. The totality of the data presented at ASH reinforces our belief that pacritinib has the potential to be an important therapy for severely thrombocytopenic myelofibrosis patients, a population for whom available therapeutic options are limited and often ineffective."

    "While currently available treatments for myelofibrosis convey clinical benefit to a majority of the population, patients who are severely thrombocytopenic, and are therefore considered high-risk, continue to lack safe and efficacious therapies," said Claire N. Harrison, M.D., Consultant Haematologist and Professor of Myeloproliferative Neoplasms in London, as well as Chair of the PACIFICA steering committee and Principal Investigator of the PAC203 Phase 2 trial. "Myelofibrosis patients with platelet counts of less than 50,000 per microliter have a median survival of approximately 8 months after discontinuation of first line ruxolitinib therapy. In the PAC203 Phase 2 trial, which represents one of the most advanced and heavily pre-treated myelofibrosis patient populations studied to date as demonstrated by a median prior exposure to ruxolitinib of 1.7 years and the high risk mutational profiles, pacritinib at 200 mg BID achieved an impressive response rate in the severely thrombocytopenic patient population of 17% with a promising safety profile, demonstrating its potential to change the treatment paradigm in this area of serious unmet medical need."  

    All posters and presentation materials will be available at ctibiopharma.com following the presentations.

    Results of PAC203: A Randomized Phase 2 Dose-Finding Study and Determination of the Recommended Dose of Pacritinib

    Results from the PAC203 Phase 2 trial are being presented today, Monday, December 9, at 10:30 AM ET, in an oral presentation session.

    Abstract: No. 667

    Summary: PAC203 enrolled patients with myelofibrosis who were intolerant of or who had not benefitted from prior treatment with ruxolitinib. Patients were randomized in equal measure across 3 dosing arms: 200mg twice-daily (BID), 100mg BID, and 100mg daily (QD), with randomization stratified by baseline platelet count. Patients were mostly thrombocytopenic and anemic at baseline, with a median platelet count was 55,000, and 44% of patients having baseline platelet counts of less than 50,000. Patients had been heavily pre-treated with ruxolitinib, with a median 1.7 years of prior exposure. The study endpoint was broadly defined as an analysis of safety and efficacy data across dosing arms based on data after all patients either reached week 24 or stopped study treatment.

    Pacritinib was shown to be generally well tolerated across dosing cohorts, with the most common treatment-emergent non-hematologic adverse events (AEs) being gastrointestinal, including diarrhea (20.5%; Grade 3: 3.1%) and nausea (20%; Grade 3: 0.6%), distributed similarly across arms. The most common hematologic AEs were thrombocytopenia and anemia, both occurring at higher frequencies at the 200 mg dose BID (32% and 22% respectively); this did not, however, lead to higher rates of Grade 3/4 hemorrhage at higher doses (200 mg BID: 5.6%; 100 mg BID: 0%; 100 mg QD: 5.8%; all Grade 3). Similarly, the highest dose saw no excess in Grade 3/4 cardiac (200 mg BID: 3.7%; 100 mg BID: 7.3%; 100 mg QD: 3.7%; all Grade 3) or infectious (200 mg BID: 15%; 100 mg BID: 11%; 100 mg QD: 12%) AEs. In this cohort of advanced MF patients, there were 7 Grade 5 (fatal) AEs: 2 at 200 mg BID (sepsis, subdural hematoma), 3 at 100 mg BID (disease progression, subdural hematoma, heart failure), and 2 at 100 mg QD (sepsis, tuberculosis).

    The 200 mg BID arm had the highest observed rates of SVR ≥35% (200 mg BID: 9.3%; 100 mg BID: 1.8%; 100 mg QD: 0.0%). Of the 5 patients with SVR ≥35% at the 200 mg BID dose, 4 had platelet counts <50,000/mL, representing a 17% (4/24) response rate among patients with severe thrombocytopenia. Though a dose response relationship was not observed in total symptom score (TSS) based on the threshold of 50% reduction in symptom score, as 4 patients achieved this endpoint on all arms, the median reduction in TSS was greatest for patients treated at 200 mg BID (200 mg BID: 27%%; 100 mg BID: 16%; 100 mg QD: 3%).

    The data from PAC203 support the Phase 3 PACIFICA trial, currently underway to compare the safety and efficacy of 200 mg BID of pacritinib to Physician's Choice in 180 adult myelofibrosis patients with severe thrombocytopenia (platelet counts of less than 50,000 per microliter).

    The Oral JAK2/IRAK1 Inhibitor Pacritinib Demonstrates Spleen Volume Reduction in Myelofibrosis Patients Independent of JAK2V617F Allele Burden

    Results from a retrospective analysis from two Phase 3 studies, PERSIST-1 and PERSIST-2, of pacritinib in myelofibrosis patients were presented in a poster session on Saturday, December 7.

    Abstract: No. 1674

    Summary: A retrospective analysis of PERSIST-1 and PERSIST-2 was performed in which outcomes were stratified by JAK2 V617F mutation status and allele burden. The efficacy endpoint for this study was the percentage of patients achieving ≥35% SVR at week 24 based on an intention-to-treat analysis. Analysis was based on pooled results across the two studies for patients treated with pacritinib and those treated with best available therapy (BAT), and assessed patients with JAK2 V617F for possible relationship between allelic burden and SVR at 24 weeks. The analysis showed pacritinib was associated with a significantly higher rate of SVR response than BAT among patients with low JAK2 allele burden (<50%), while no SVR response was observed for patients treated with BAT (including ruxolitinib) who had low JAK2 allele burden or JAK2 V617F-negative disease. This data suggests that pacritinib, a JAK2/IRAK1 inhibitor, may provide benefit over a wider range of patients with myelofibrosis compared to other JAK inhibitors, specifically patients with low JAK2 allele burden who were shown to have lower baseline platelet counts, more severe anemia and smaller spleen size.

    Pacritinib Demonstrates Efficacy Versus Best Available Therapy in Myelofibrosis Patients with Severe Thrombocytopenia in Two Phase 3 Studies

    Results from a retrospective analysis of PERSIST-1 and PERSIST-2 will be presented in a poster session today, Monday, December 9 at 6:00 PM ET.

    Abstract: No. 4195

    Summary: This analysis was performed in patients treated on PERSIST-1 and PERSIST-2 with a baseline platelet count <50,000/μL. At 24 weeks, significantly more patients achieved ≥35% SVR with pacritinib compared with BAT (P-values <0.01). Although not statistically significant, TSS reductions ≥50% nearly doubled for those receiving pacritinib versus BAT. The safety profile in patients with severe thrombocytopenia was generally manageable and consistent with the overall study populations from the two Phase 3 trials. This retrospective analysis represents the largest population of patients with MF and severe thrombocytopenia to be studied in clinical trials, a population with a serious unmet medical need, and the results illustrate the clinical activity of pacritinib in the treatment of these patients.

    Molecular Analysis in the Pacritinib Dose-Finding PAC203 Study in Patients with Myelofibrosis Refractory or Intolerant to Ruxolitinib

    Results from a baseline mutational analysis of patients enrolled in the Phase 2 PAC203 study of pacritinib in patients with myelofibrosis will be presented in a poster session today, December 9, 2019 at 6:00 PM ET.

    Abstract: No. 4214

    Summary: The baseline mutational analysis was performed on 105 (out of total 164 recruited, 161 treated) myelofibrosis patients in the PAC203 study. The PAC203 cohort, characterized by ruxolitinib failure and a high burden of anemia and thrombocytopenia, was shown to be a molecularly high-risk population, characterized by high incidence of HMR, TP53 and RAS mutations, high mutational burden, and low incidence of CALR mutations.

    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 anemia, weakness, fatigue and an enlarged spleen and liver. Patients with severe thrombocytopenia are estimated to make up more than one-third of patients treated for myelofibrosis, or approximately 18,000 people.1 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.2 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.3,4 There are currently no approved therapies available to treat myelofibrosis patients with severe thrombocytopenia, or patients who have failed ruxolitinib treatment, thereby making this a significant unmet medical need.

    About Pacritinib

    Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukemia and lymphoma. In addition to myelofibrosis, the kinase profile of pacritinib suggests its potential therapeutic utility in conditions such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), and chronic lymphocytic leukemia (CLL), due to its inhibition of c-fms, IRAK1, JAK2 and FLT3.

    About CTI BioPharma Corp.

    CTI BioPharma Corp. is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. In particular, we are focused on evaluating pacritinib for the treatment of adult patients with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding our expectations regarding: the anticipated trial design of the PACIFICA Phase 3 trial, including potential changes to the protocol as discussed in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2019; the anticipated enrollment of the PACIFICA Phase 3 trial; the effectiveness of, and potential changes to, the PACIFICA Phase 3 trial design; the timing of, and results from, clinical trials and other development activities related to pacritinib, including the PACIFICA Phase 3 trial and its related protocol; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of pacritinib; the anticipated timing of regulatory submissions and interactions; our ability to expedite the regulatory approval process; our ability to successfully develop and achieve milestones in the development of pacritinib; and the anticipated benefits of pacritinib.

    Risks Related to Forward-Looking Statements

    The forward-looking statements contained in this press release are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of pacritinib; the FDA may determine that the benefit/risk profile of pacritinib at the dose selected for the PACIFICA Phase 3 trial does not support approval based on the results of such trial, previously identified FDA concerns regarding safety and dosing limitations or otherwise; pacritinib may fail in development, may not receive required regulatory approvals, or may be delayed to a point where it is not commercially viable; as discussed more fully in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, if investors view negatively FDA's suggested change to the PACIFICA Phase 3 trial to include TSS as a co-primary endpoint or other potential changes to the PACIFICA Phase 3 trial that would increase the cost of the study and prolong the study, or if we are unable to expedite the regulatory approval process, we may be required to pursue strategic alternatives for the development of pacritinib and/or our company; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; we may not achieve additional milestones in our pacritinib development program; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "CTI BioPharma" and the CTI BioPharma logo are registered trademarks or trademarks of CTI BioPharma Corp. in various jurisdictions. All other trademarks belong to their respective owner.

    CTI BioPharma Investor Contacts:
    Maeve Conneighton/Maghan Meyers
    +212-600-1902

    CTI BioPharma Corp. Logo (PRNewsFoto/Cell Therapeutics, Inc.)

     

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  25. SEATTLE, Nov. 6, 2019 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced four poster presentations and one oral presentation supporting the Company's pacritinib development program at the 61st American Society of Hematology (ASH) Annual Meeting being held December 7- 10, 2019 in Orlando, Florida.

    The details of the oral presentation are as follows:

    Abstract Title: Results of PAC203: A Randomized Phase 2 Dose-Finding Study and Determination of the Recommended Dose of Pacritinib
    Session Number: 634
    Session Name: Myeloproliferative Syndromes: Clinical: JAK Inhibitors and Combination Therapies
    Session Date: Monday, December 9, 2019
    Session Time: 10:30 AM - 12:00 PM
    Presentation Time: 10:30 AM
    Publication Number: 667
    Location: Orange…

    SEATTLE, Nov. 6, 2019 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced four poster presentations and one oral presentation supporting the Company's pacritinib development program at the 61st American Society of Hematology (ASH) Annual Meeting being held December 7- 10, 2019 in Orlando, Florida.

    The details of the oral presentation are as follows:

    Abstract Title: Results of PAC203: A Randomized Phase 2 Dose-Finding Study and Determination of the Recommended Dose of Pacritinib
    Session Number: 634
    Session Name: Myeloproliferative Syndromes: Clinical: JAK Inhibitors and Combination Therapies
    Session Date: Monday, December 9, 2019
    Session Time: 10:30 AM - 12:00 PM
    Presentation Time: 10:30 AM
    Publication Number: 667
    Location: Orange County Convention Center, W311EFGH  

    The details of the poster presentations are as follows:

    Abstract Title: The Oral JAK2/IRAK1 Inhibitor Pacritinib Demonstrates Spleen Volume Reduction in Myelofibrosis Patients Independent of JAK2V617F Allele Burden
    Session Number: 634
    Session Name: Myeloproliferative Syndromes: Clinical: Poster I
    Date: Saturday, December 7, 2019
    Presentation Time: 5:30 PM - 7:30 PM
    Publication Number: 1674
    Location: Orange County Convention Center, Hall B

    Abstract Title: Pacifica: A Randomized, Controlled Phase 3 Study of Pacritinib Vs. Physician's Choice in Patients with Primary Myelofibrosis, Post Polycythemia Vera Myelofibrosis, or Post Essential Thrombocytopenia Myelofibrosis with Severe Thrombocytopenia (Platelet Count <50,000/mL)
    Session Number: 634
    Session Name: Myeloproliferative Syndromes: Clinical: Poster III 
    Date: Monday, December 9, 2019 
    Presentation Time: 6:00 PM - 8:00 PM 
    Publication Number: 4175 
    Location: Orange County Convention Center, Hall B

    Abstract Title: Pacritinib Demonstrates Efficacy Versus Best Available Therapy in Myelofibrosis Patients with Severe Thrombocytopenia in Two Phase 3 Studies
    Session Number: 634
    Session Name: Myeloproliferative Syndromes: Clinical: Poster III
    Date: Monday, December 9, 2019
    Presentation Time: 6:00 PM - 8:00 PM 
    Publication Number: 4195
    Location: Orange County Convention Center, Hall B

    Abstract Title: Molecular Analysis in the Pacritinib Dose-Finding PAC203 Study in Patients with Myelofibrosis Refractory or Intolerant to Ruxolitinib
    Session Number: 635
    Session Name: Myeloproliferative Syndromes: Basic Science: Poster III
    Date: Monday, December 9, 2019
    Presentation Time: 6:00 PM - 8:00 PM
    Publication Number: 4214
    Location: Orange County Convention Center, Hall B

    A copy of each abstract is available here.

    About CTI BioPharma Corp.
    CTI BioPharma Corp. is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. In particular, we are focused on evaluating pacritinib for the treatment of adult patients with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington.

    "CTI BioPharma" and the CTI BioPharma logo are registered trademarks or trademarks of CTI BioPharma Corp. in various jurisdictions. All other trademarks belong to their respective owner.

    CTI BioPharma Investor Contacts:
    Maeve Conneighton/Maghan Meyers
    +212-600-1902

     

    Cision View original content:http://www.prnewswire.com/news-releases/cti-biopharma-announces-presentations-at-the-61st-american-society-of-hematology-meeting-300952889.html

    SOURCE CTI BioPharma Corp.

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  26. SEATTLE, Nov. 4, 2019 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today reported its financial results for the third quarter and nine months ended September 30, 2019.

    "We advanced our pacritinib development program in the third quarter, and recently took an important step forward for the company by initiating and enrolling the first patient in the PACIFICA trial, our pivotal Phase 3 trial of pacritinib in myelofibrosis patients with severe thrombocytopenia," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "An estimated one-third of patients with myelofibrosis are severely thrombocytopenic - a population with limited therapeutic options and poor survival, thereby making this disease setting a very

    SEATTLE, Nov. 4, 2019 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today reported its financial results for the third quarter and nine months ended September 30, 2019.

    "We advanced our pacritinib development program in the third quarter, and recently took an important step forward for the company by initiating and enrolling the first patient in the PACIFICA trial, our pivotal Phase 3 trial of pacritinib in myelofibrosis patients with severe thrombocytopenia," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "An estimated one-third of patients with myelofibrosis are severely thrombocytopenic - a population with limited therapeutic options and poor survival, thereby making this disease setting a very important area of unmet medical need. In the near-term, we look forward to presenting results from the PAC203 Phase 2 trial at a scientific conference before the end of the year."

    Third Quarter Financial Results
    Operating loss was $9.7 million and $31.2 million for the three and nine months ended September 30, 2019, respectively, compared to operating loss of $14.8 million and $33.1 million for the respective periods in 2018. The decrease in operating loss during the three-month period ended September 30, 2019 as compared to the comparable period in 2018 resulted primarily from a decrease in operating expenses as well as the increase in license and contract revenues as discussed below. The decrease in operating loss for the nine months ended September 30, 2019 as compared to the same period in 2018 resulted primarily from a decrease in operating expenses, offset by the decrease in license and contract revenue between periods. As of September 30, 2019, cash, cash equivalents and short-term investments totaled $46.7 million, compared to $67.0 million as of December 31, 2018. CTI BioPharma expects current cash, cash equivalents and short-term investments will enable it to fund its operations into the third quarter of 2020.

    License and contract revenues for the three and nine months ended September 30, 2019 were $2.3 million and $3.3 million, respectively, compared to $0.7 million and $12.2 million for the respective periods in 2018. The increase in license and contract revenues for the three months ended September 30, 2019 compared to the comparable period in 2018 is primarily due to revenue recognized in connection with the asset purchase agreement with our partner Les Laboratoires Servier and Institut de Recherches Internationales Servier. The decrease in license and contract revenues for the nine months ended September 30, 2019 compared to the same period in 2018 is primarily due to the recognition of $10.0 million in milestone revenue in 2018 from Teva Pharmaceutical Industries Ltd. related to the achievement of a milestone for FDA approval of TRISENOX® (arsenic trioxide) for first-line treatment of acute promyelocytic leukemia. There were no such revenues for the comparable period in 2019.

    Net loss attributable to common stockholders for the three months ended September 30, 2019 was $10.0 million, or $(0.17) for basic and diluted loss per share, compared to net loss attributable to common stockholders of $14.8 million, or $(0.26) for basic and diluted loss per share, for the same period in 2018. Net loss attributable to common stockholders for the nine months ended September 30, 2019 was $31.8 million, or $(0.55) for basic and diluted loss per share, compared to net loss attributable to common stockholders of $30.2 million, or $(0.55) for basic and diluted loss per share, for the same period in 2018.

    About CTI BioPharma Corp.
    CTI BioPharma Corp. is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. In particular, we are focused on evaluating pacritinib for the treatment of adult patients with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington.

    Forward-Looking Statements
    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding our expectations regarding: the anticipated trial design of the PACIFICA Phase 3 trial, including potential changes to the protocol as discussed in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2019; the anticipated enrollment of the PACIFICA Phase 3 trial; the effectiveness of, and potential changes to, the PACIFICA Phase 3 trial design; the timing of, and results from, clinical trials and other development activities related to pacritinib, including the PACIFICA Phase 3 trial and its related protocol; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of pacritinib; the anticipated timing of regulatory submissions and interactions; our ability to expedite the regulatory approval process; our ability to successfully develop and achieve milestones in the development of pacritinib; and the anticipated benefits of pacritinib.

    Risks Related to Forward-Looking Statements
    The forward-looking statements contained in this press release are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of pacritinib; the FDA may determine that the benefit/risk profile of pacritinib at the dose selected for the PACIFICA Phase 3 trial does not support approval based on the results of such trial, previously identified FDA concerns regarding safety and dosing limitations or otherwise; pacritinib may fail in development, may not receive required regulatory approvals, or may be delayed to a point where it is not commercially viable; as discussed more fully in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2019, if investors view negatively FDA's suggested change to the PACIFICA Phase 3 trial to include TSS as a co-primary endpoint or other potential changes to the PACIFICA Phase 3 trial that would increase the cost of the study and prolong the study, or if we are unable to expedite the regulatory approval process, we may be required to pursue strategic alternatives for the development of pacritinib and/or our company; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; we may not achieve additional milestones in our pacritinib development program; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "CTI BioPharma" and the CTI BioPharma logo are registered trademarks or trademarks of CTI BioPharma Corp. in various jurisdictions. All other trademarks belong to their respective owner.

    CTI BioPharma Investor Contacts:
    Maeve Conneighton/Maghan Meyers
    +212-600-1902

    (tables follow)

    CTI BioPharma Corp.

    Condensed Consolidated Statements of Operations

    (In thousands, except per share amounts)

    (unaudited)



    Three Months Ended

     September 30,


    Nine Months Ended

     September 30,


    2019


    2018


    2019


    2018

    License and contract revenues

    $

    2,289



    $

    723



    $

    3,345



    $

    12,182


    Operating costs and expenses:








    Research and development

    7,598



    9,730



    19,126



    28,539


    Selling, general and administrative

    4,403



    5,763



    14,662



    16,750


    Restructuring expenses





    794




    Total operating costs and expenses

    12,001



    15,493



    34,582



    45,289


    Loss from operations

    (9,712)



    (14,770)



    (31,237)



    (33,107)


    Non-operating income (expense):








    Interest income

    276



    436



    1,003



    800


    Interest expense

    (240)



    (308)



    (803)



    (893)


    Amortization of debt discount and issuance costs

    (131)



    (130)



    (391)



    (394)


    Foreign exchange loss

    (240)



    (46)



    (409)



    (898)


    Other non-operating income







    4,295


    Total non-operating (expense) income, net

    (335)



    (48)



    (600)



    2,910


    Net loss before noncontrolling interest

    (10,047)



    (14,818)



    (31,837)



    (30,197)


    Noncontrolling interest



    9



    5



    31


    Net loss

    (10,047)



    (14,809)



    (31,832)



    (30,166)


         Deemed dividends on preferred stock







    (80)


    Net loss attributable to common stockholders

    $

    (10,047)



    $

    (14,809)



    $

    (31,832)



    $

    (30,246)


    Basic and diluted net loss per common share

    $

    (0.17)



    $

    (0.26)



    $

    (0.55)



    $

    (0.55)


    Shares used in calculation of basic and diluted net loss per common share:

    57,974



    57,964



    57,973



    55,434


     

    Balance Sheet Data (unaudited):


    (amounts in thousands)



    September 30,


    December 31,



    2019


    2018

    Cash and cash equivalents


    $

    34,917



    $

    36,439


    Short-term investments


    11,815



    30,599


    Working capital


    21,748



    59,437


    Total assets


    58,582



    89,832


    Current portion of long-term debt


    10,470



    4,812


    Long-term debt, less current portion




    9,267


    Total stockholders' equity


    26,191



    52,939


     

    CTI BioPharma Corp. Logo (PRNewsFoto/Cell Therapeutics, Inc.)

     

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  27. SEATTLE, Oct. 1, 2019 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced that it has initiated patient enrollment in the PACIFICA pivotal Phase 3 trial of its investigational myelofibrosis treatment candidate, pacritinib. The PACIFICA trial will compare the safety and efficacy of 200 mg of pacritinib administered twice daily (BID) to Physician's Choice in 180 adult myelofibrosis patients with severe thrombocytopenia (platelet counts of less than 50,000 per microliter).

    "Initiation of the PACIFICA Phase 3 trial is an important step forward for the company and the pacritinib development program," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "An estimated one-third of patients with myelofibrosis

    SEATTLE, Oct. 1, 2019 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ:CTIC) today announced that it has initiated patient enrollment in the PACIFICA pivotal Phase 3 trial of its investigational myelofibrosis treatment candidate, pacritinib. The PACIFICA trial will compare the safety and efficacy of 200 mg of pacritinib administered twice daily (BID) to Physician's Choice in 180 adult myelofibrosis patients with severe thrombocytopenia (platelet counts of less than 50,000 per microliter).

    "Initiation of the PACIFICA Phase 3 trial is an important step forward for the company and the pacritinib development program," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "An estimated one-third of patients with myelofibrosis are severely thrombocytopenic  a population with limited therapeutic options and poor survival, thereby making this disease setting a very important area of unmet medical need. Moving forward, successful trial execution is our primary focus, and with patient enrollment now underway, we expect to report topline results in mid-2021."

    The PACIFICA trial is a randomized, active-comparator trial designed to evaluate the safety and efficacy of 200 mg of pacritinib administered twice daily (BID) compared to Physician's Choice in 180 myelofibrosis patients with severe thrombocytopenia (platelet counts of less than 50,000 per microliter). Patients will be randomized in a ratio of 2:1 between pacritinib and Physician's Choice, which may include steroids, thalidomide or lenolidamide, hydroxyurea or low-dose ruxolitinib. The primary endpoint of the trial is the percentage of patients who achieve at least 35% reduction in spleen volume at 24 weeks. Dr. Srdam Verstovsek, Professor, Department of Leukemia, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center, and Dr. John Mascarenhas, Associate Professor of Medicine Myeloproliferative Disorders Program, Tisch Cancer Institute, Mount Sinai School of Medicine, will be co-principal investigators in the PACIFICA trial. Professor Claire Harrison, Professor of Medicine, Guy's and St Thomas' NHS Foundation Trust, London, will chair the trial's Steering Committee.

    The PACIFICA trial initiation follows the Type B, End-of-Phase-2a meeting with the U.S. Food and Drug Administration ("FDA" or "the Agency") held in July 2019 and the FDA's acceptance of an amendment to the company's PAC203 trial protocol, which has enabled a rapid transition to the PACIFICA Phase 3 trial. Results from the randomized, open-label Phase 2 PAC203 dose-finding trial are expected to be presented at a scientific conference before the end of 2019. For more information on the PACIFICA Phase 3 trial, please go to PACIFICA-trial.com.

    The company's previously conducted Phase 3 PERSIST program consisted of the PERSIST-1 trial, which included a broad set of patients without limitations on platelet counts, and the PERSIST-2 trial, which was conducted in patients with low platelet counts. An ad-hoc analysis of pooled data from PERSIST-1 and PERSIST-2 evaluated results from patients with platelet counts of less than 50,000 per microliter and showed that 23% (n=104) of patients administered pacritinib had a ≥35% spleen volume reduction (SVR), compared to 2% (n=48) (p=0.0007) given the best available therapy, which in the PERSIST-1 trial excluded JAK2 inhibitors and in the PERSIST-2 trial included the approved JAK2 inhibitor, ruxolitinib. The most common treatment-emergent adverse events of any grade occurring in 20% or more of patients treated with pacritinib within 24 weeks during the PERSIST-1 and PERSIST-2 trials were gastrointestinal (generally manageable diarrhea, nausea and vomiting) and hematologic (anemia and thrombocytopenia).

    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 anemia, weakness, fatigue and an enlarged spleen and liver. Patients with severe thrombocytopenia are estimated to make up more than one-third of patients treated for myelofibrosis, or approximately 18,000 people.1 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.2 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.3,4 There are currently no approved therapies available to treat myelofibrosis patients with severe thrombocytopenia, or patients who have failed ruxolitinib treatment, thereby making this a significant unmet medical need.

    About Pacritinib
    Pacritinib is an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R. The JAK family of enzymes is a central component in signal transduction pathways, which are critical to normal blood cell growth and development, as well as inflammatory cytokine expression and immune responses. Mutations in these kinases have been shown to be directly related to the development of a variety of blood-related cancers, including myeloproliferative neoplasms, leukemia and lymphoma. In addition to myelofibrosis, the kinase profile of pacritinib suggests its potential therapeutic utility in conditions such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), chronic myelomonocytic leukemia (CMML), and chronic lymphocytic leukemia (CLL), due to its inhibition of c-fms, IRAK1, JAK2 and FLT3.

    About CTI BioPharma Corp.
    CTI BioPharma Corp. is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies for blood-related cancers that offer a unique benefit to patients and their healthcare providers. In particular, we are focused on evaluating pacritinib for the treatment of adult patients with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington.

    Forward-Looking Statements
    This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding our expectations regarding: the effectiveness of, and potential changes to, the PACIFICA Phase 3 trial design; the timing of, and results from, clinical trials and other development activities related to pacritinib, including the anticipated PACIFICA Phase 3 trial and its related protocol; the potential efficacy, safety profile, future development plans, addressable market, regulatory success and commercial potential of pacritinib; the anticipated timing of regulatory submissions and interactions; our ability to successfully develop and achieve milestones in the development of pacritinib; and the anticipated benefits of pacritinib. These forward-looking statements are based on current assumptions that involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. These risks and uncertainties, many of which are beyond our control, include, but are not limited to: clinical trials may not demonstrate safety and efficacy of pacritinib; the FDA may determine that the benefit/risk profile of pacritinib at the dose selected for the PACIFICA Phase 3 trial does not support approval based on the results of such trial, previously identified FDA concerns regarding safety and dosing limitations or otherwise; pacritinib may fail in development, may not receive required regulatory approvals, or may be delayed to a point where it is not commercially viable; our assumptions regarding our planned expenditures and sufficiency of our cash to fund operations may be incorrect; we may not achieve additional milestones in our pacritinib development program; the impact of competition; the impact of expanded product development and clinical activities on operating expenses; adverse conditions in the general domestic and global economic markets; as well as the other risks identified in our filings with the Securities and Exchange Commission. These forward-looking statements speak only as of the date hereof and we assume no obligation to update these forward-looking statements, and readers are cautioned not to place undue reliance on such forward-looking statements.

    "CTI BioPharma" and the CTI BioPharma logo are registered trademarks or trademarks of CTI BioPharma Corp. in various jurisdictions. All other trademarks belong to their respective owner.

    1 Company estimates based on internal company research
    2 Masarova et al., Eur J Haematolol. 2017
    3 Newberry, Blood 2017
    4 Mehra, et al. ASH 2016 poster, Abstract 4769

    CTI BioPharma Investor Contacts:
    Maeve Conneighton/Maghan Meyers
    +212-600-1902

    CTI BioPharma Corp. Logo (PRNewsFoto/Cell Therapeutics, Inc.)

     

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