News Article | April 25, 2017
PARIS & SEATTLE--(BUSINESS WIRE)--Servier and CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) today jointly announced that they agreed to expand their existing license and development collaboration agreement for PIXUVRI® (pixantrone). Under this expanded agreement, Servier will have rights to PIXUVRI in all markets except the US, where CTI BioPharma will retain the commercialization rights. Servier will pay CTI BioPharma €12 million with the potential for CTI BioPharma to receive €76
News Article | April 26, 2017
To access the live audio webcast or the subsequent archived recording, visit CTI BioPharma's website, www.ctibiopharma.com. Webcast and telephone replays of the conference call will be available at approximately two hours after completion of the call. Callers can access the replay by dialing 1-888-203-1112 (domestic) or +1 719-457-0820 (international). The access code for the replay is 1369799. The telephone replay will be available until Wednesday, May 10, 2017. CTI BioPharma Corp. is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies covering a spectrum of blood-related cancers that offer a unique benefit to patients and healthcare providers. CTI BioPharma has a late-stage development pipeline, including pacritinib for the treatment of patients with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington. For additional information and to sign up for email alerts and get RSS feeds, please visit www.ctibiopharma.com. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/cti-biopharma-to-report-first-quarter-2017-financial-results-on-may-3-2017-300446540.html
News Article | August 3, 2017
"Over the last quarter we have worked hard to become a leaner, more focused company that is adequately financed to meet our objectives," said Adam R. Craig, M.D., Ph.D., President and Chief Executive Officer of CTI BioPharma. "The EMA validated the MAA for pacritinib which is now under review and the PAC203 trial is now enrolling. Our cash position has improved through an expanded partnership with Servier and the recent $45 million financing. Changes to the board have added three new independent board members with many years of experience in successfully developing and commercializing novel therapeutics." Total revenues for the second quarter and six months ended June 30, 2017, were $22.2 million and 23.0 million, respectively, compared to $7.4 million and $43.8 million for the respective periods in 2016. The increase in total revenues for the second quarter compared to the same period in 2016 is primarily due to license and contract revenue that includes the recognition of payments received from the expansion of the license and collaboration agreement for PIXUVRI® with Servier and the receipt of a payment from Teva Pharmaceutical Industries Ltd. related to the achievement of sales milestones for TRISENOX® (arsenic trioxide). The decrease in total revenues for the six months of 2017 is primarily due to recognition of $32 million in milestone revenue related to pacritinib in the first quarter of 2016. Net product sales of PIXUVRI for the second quarter and six months ended June 30, 2017, were $0.3 million and $1.0 million, respectively, compared to $1.1 million and $2.3 million for the respective periods in 2016 GAAP operating income for the second quarter was $5.3 million and GAAP operating loss for the six months was $14.0 million for the period ended June 30, 2017, compared to GAAP operating loss of $19.1 million and $14.9 million for the respective periods in 2016. Non-GAAP operating income, which excludes non-cash share-based compensation expense, for the second quarter was $6.4 million and non-GAAP operating loss for the six months was $11.1 million for the period ended June 30, 2017, compared to non-GAAP operating loss of $16.7 million and $8.8 million for the respective periods in 2016. Non-cash share-based compensation expense for the second quarter and six months ended June 30, 2017, was $1.1 million and $2.9 million, respectively, compared to $2.3 million and $6.2 million for the respective periods in 2016. Operating income in the second quarter of 2017 as compared to an operating loss for the same period in 2016 resulted primarily from the increase in license and contract revenue as mentioned above and decrease in research and development and selling, general and administrative expenses. For information on CTI BioPharma's use of non-GAAP operating loss and a reconciliation of such measure to GAAP operating loss, see the section below entitled "Non-GAAP Financial Measures." Net income for the second quarter of 2017 was $1.0 million, or $0.03 per share, compared to a net loss of $19.8 million, or ($0.71) per share, for the same period in 2016. Net loss for six months ended June 30, 2017, was $18.8 million, or ($0.63) per share, compared to a net loss of $16.5 million, or ($0.59) per share, for the same period in 2016. As of June 30, 2017, cash and cash equivalents totaled $74.7 million, compared to $44.0 million at December 31, 2016. CTI BioPharma management will host a conference call to review its second quarter 2017 financial results and provide an update on business activities. The event will be held today at 1:30 p.m. PT / 4:30 p.m. ET / 10:30 p.m. CEST. Participants can access the call at 1-888-471-3820 (domestic) or +1 719-325-2478 (international). To access the live audio webcast or the subsequent archived recording, visit www.ctibiopharma.com. Webcast and telephone replays of the conference call will be available approximately two hours after completion of the call. Callers can access the replay by dialing 1-888-203-1112 (domestic) or +1 719-457-0820 (international). The access code for the replay is 4391425. The telephone replay will be available until Thursday, August 10, 2017. CTI BioPharma Corp. is a biopharmaceutical company focused on the acquisition, development and commercialization of novel targeted therapies covering a spectrum of blood-related cancers that offer a unique benefit to patients and healthcare providers. CTI BioPharma has a late-stage development pipeline, including pacritinib for the treatment of patients with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington. For additional information and to sign up for email alerts and get RSS feeds, please visit www.ctibiopharma.com. CTI BioPharma has provided in this press release the historical non-GAAP financial measure of operating income (loss), excluding non-cash share-based compensation expense, for the second quarter and six months ended June 30, 2017 and June 30, 2016. Due to varying available valuation methodologies, subjective assumptions and the different GAAP accounting treatment of different award types that companies can use under ASC Topic 718, CTI BioPharma's management believes that providing a non-GAAP financial measure that excludes non-cash share-based compensation expense can enhance management's and investors' comparison of CTI BioPharma's operating results over different periods of time as compared to the operating results of other companies. CTI BioPharma's use of a non-GAAP financial measure has limitations and should not be considered in isolation from, or as a substitute for, financial information prepared in accordance with GAAP. One limitation is that CTI BioPharma's reported non-GAAP operating income (loss) in 2017 results in the exclusion of a recurring expense, since CTI BioPharma expects that share-based compensation will continue to be a significant recurring expense in CTI BioPharma's business. A second limitation is that CTI BioPharma's methodology for calculating non-GAAP operating income (loss), which only excludes the component of share-based compensation, may differ from the methodology CTI BioPharma's peer companies utilize to the extent they report non-GAAP operating income or similarly titled measures. Accordingly, CTI BioPharma's non-GAAP operating income (loss) may not necessarily be comparable to similarly titled measures of other companies. Investors are urged to review the reconciliation of these non-GAAP measures to their most directly comparable GAAP financial measures. A reconciliation of CTI BioPharma's non-GAAP financial measures to the most directly comparable GAAP measures has been provided in the financial statement tables included below in this press release. This press release includes forward-looking statements within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are subject to a number of risks and uncertainties, the outcome of which could materially and/or adversely affect actual future results and the trading price of CTI BioPharma's securities. Such statements include, but are not limited to, expectations with respect to the timing and planned enrollment of PAC203 and our ability to interpret clinical trial data and results for PERSIST-2 despite not satisfying the pre-specified minimum evaluable patient goal, expectations with respect to the potential therapeutic utility of pacritinib, statements regarding CTI BioPharma's expectations with respect to the potential of pacritinib to achieve treatment goals, the development of CTI BioPharma and its product and product candidate portfolio, including the advancement of pacritinib and other pipeline programs, CTI BioPharma's ability to achieve its goals in 2017 and beyond, CTI BioPharma's intent to continue efforts to commercialize PIXUVRI in Europe and expand the market potential for PIXUVRI, and CTI BioPharma's plans to continue advancing the development of its pipeline candidates through strategic product collaborations or cooperative group and investigator-sponsored trials, as well as the identification and acquisition of additional pipeline opportunities. Risks that contribute to the uncertain nature of the forward-looking statements include, among others, risks associated with the biopharmaceutical industry in general and with CTI BioPharma and its product and product candidate portfolio in particular including, among others, risks associated with the following: that CTI BioPharma cannot predict or guarantee the outcome of preclinical and clinical studies, the potential failure of pacritinib to prove safe and effective as determined by the FDA and/or the European Medicines Agency, changes to study protocol or design or sample size to address any patient safety, efficacy or other issues raised by the FDA or otherwise, that top-line results observed to date may differ from future results or that different conclusions or considerations may qualify such results once existing data has been more fully evaluated, that CTI BioPharma may not obtain favorable determinations by other regulatory, patent and administrative governmental authorities, that CTI BioPharma may experience delays in the commencement of preclinical and clinical studies, that the costs of developing pacritinib and CTI BioPharma's other product candidates may rise; other risks, including, without limitation, competitive factors, technological developments, that CTI BioPharma may not be able to sustain its current cost controls or further reduce its operating expenses, that CTI BioPharma may not achieve previously announced goals, contractual milestones and objectives as or when projected, that CTI BioPharma's average net operating burn rate may increase, that CTI BioPharma will continue to need to raise capital to fund its operating expenses, but may not be able to raise sufficient amounts to fund its continued operation; as well as other risks listed or described from time to time in CTI BioPharma's most recent filings with the SEC on Forms 10-K, 10-Q and 8-K. Except as required by law, CTI BioPharma does not intend to update any of the statements in this press release upon further developments.
News Article | December 9, 2016
— Follicular Lymphoma Pipeline Market Companies Involved in Therapeutics Development are AbbVie Inc, Affimed GmbH, Amgen Inc, Asana BioSciences LLC, Bayer AG, BeiGene Ltd, Bio-Path Holdings Inc, Biocon Ltd, Biogen Inc, Biogenomics Limited, Biothera Pharmaceutical Inc, Boehringer Ingelheim GmbH, Bristol-Myers Squibb Company, Celgene Corp, Celldex Therapeutics Inc, Celltrion Inc, Cellular Biomedicine Group Inc, Coherus BioSciences Inc, Constellation Pharmaceuticals Inc, CSPC Pharmaceutical Group Limited, CTI BioPharma Corp, Curis Inc, Dynavax Technologies Corp, Eisai Co Ltd, EpiZyme Inc, F. Hoffmann-La Roche Ltd, Genentech Inc, Gilead Sciences Inc, GlaxoSmithKline Plc, Hutchison MediPharma Ltd, Immune Design Corp, ImmunoGen Inc, Immunomedics Inc, Johnson & Johnson, Juno Therapeutics Inc, Karyopharm Therapeutics Inc, Kite Pharma Inc, MedImmune LLC, Medivation Inc, MEI Pharma Inc, Merck & Co Inc, Merck KGaA, Millennium Pharmaceuticals Inc, Mirati Therapeutics Inc, MorphoSys AG, Nordic Nanovector ASA, Novartis AG, Ono Pharmaceutical Co Ltd, Pfizer Inc, Pharmacyclics Inc, Portola Pharmaceuticals Inc, Rhizen Pharmaceuticals SA, Sandoz International GmbH, Seattle Genetics Inc, Takeda Pharmaceutical Company Ltd, TG Therapeutics Inc and Verastem Inc. Follicular lymphoma is a common type of non-Hodgkin Lymphoma (NHL). It is a slow-growing lymphoma that arises from B-cells, a type of white blood cell. It is also called an "indolent" or "low-grade" lymphoma for its slow nature. Follicular lymphoma mainly affects older adults. Enlargement of lymph nodes is a common symptom. Fever, weight loss, sweating and fatigue are other symptoms of lymphoma. There are different types of treatment for patients with follicular lymphoma such as surgery, radiation therapy, and chemotherapy. This research provides comprehensive information on the therapeutics under development for Follicular Lymphoma (Oncology), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The guide covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Inquire more about this research at http://www.reportsnreports.com/contacts/inquirybeforebuy.aspx?name=774097 The Follicular Lymphoma (Oncology) pipeline guide also reviews of key players involved in therapeutic development for Follicular Lymphoma and features dormant and discontinued projects. The guide covers therapeutics under Development by Companies /Universities /Institutes, the molecules developed by Companies in Pre-Registration, Filing rejected/Withdrawn, Phase III, Phase II, Phase I, Preclinical and Discovery stages are 2, 1, 10, 46, 29, 8 and 1 respectively. Similarly, the Universities portfolio in Phase II and Phase I stages comprises 2 and 1 molecules, respectively. Follicular Lymphoma (Oncology) pipeline guide helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. The guide is built using data and information sourced from Global Markets Directs proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis. Note: Certain content / sections in the pipeline guide may be removed or altered based on the availability and relevance of data. • The pipeline guide provides a snapshot of the global therapeutic landscape of Follicular Lymphoma (Oncology). • The pipeline guide reviews pipeline therapeutics for Follicular Lymphoma (Oncology) by companies and universities/research institutes based on information derived from company and industry-specific sources. • The pipeline guide covers pipeline products based on several stages of development ranging from pre-registration till discovery and undisclosed stages. • The pipeline guide features descriptive drug profiles for the pipeline products which comprise, product description, descriptive licensing and collaboration details, R&D brief, MoA & other developmental activities. • The pipeline guide reviews key companies involved in Follicular Lymphoma (Oncology) therapeutics and enlists all their major and minor projects. • The pipeline guide evaluates Follicular Lymphoma (Oncology) therapeutics based on mechanism of action (MoA), drug target, route of administration (RoA) and molecule type. • The pipeline guide encapsulates all the dormant and discontinued pipeline projects. • The pipeline guide reviews latest news related to pipeline therapeutics for Follicular Lymphoma (Oncology) • Procure strategically important competitor information, analysis, and insights to formulate effective R&D strategies. • Recognize emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage. • Find and recognize significant and varied types of therapeutics under development for Follicular Lymphoma (Oncology). • Classify potential new clients or partners in the target demographic. • Develop tactical initiatives by understanding the focus areas of leading companies. • Plan mergers and acquisitions meritoriously by identifying key players and its most promising pipeline therapeutics. • Formulate corrective measures for pipeline projects by understanding Follicular Lymphoma (Oncology) pipeline depth and focus of Indication therapeutics. • Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope. • Adjust the therapeutic portfolio by recognizing discontinued projects and understand from the know-how what drove them from pipeline. For more information, please visit http://www.reportsnreports.com/reports/774097-follicular-lymphoma-pipeline-review-h2-2016.html
News Article | November 16, 2016
WiseGuyReports.Com Publish a New Market Research Report On – “Immunotherapy Drugs Market Global Potential Growth,Share,Demand and Analysis Of Key Players Research Report Forecasts to 2020”. This market research report presents a comprehensive segmentation of the global immunotherapy drugs market by type of immunotherapy (mAbs, vaccines, immune checkpoint inhibitors, non-specific immunotherapies, and others), by therapy area (oncology, infectious disease, autoimmune and inflammatory disorders, respiratory diseases, and others), and by geography (the Americas, APAC, and EMEA). Key vendors are AbbVie, Amgen, Bristol-Myers Squibb, F.Hoffmann-La Roche, Johnson & Johnson, and Merck. Overview of the global immunotherapy drugs market The market research analyst predicts that the global immunotherapy drugs market will grow at a steady CAGR of close to 12% by 2020. During a rise in cancer and a number of autoimmune diseases, the need for immunotherapy drugs is on the rise. Furthermore, with the increasing demand for mAbs, the market for immunotherapy drugs will have a positive outlook until the end of the forecast period. mAbs have a high affinity for specific disease cells and areas that need treatment. Consequently, they can be used for therapies like radioimmunotherapy and antibody-directed enzyme prodrug therapy. The augmented usage of these antibodies in drug development will help to bolster the market’s revenue generating capacity over the course of the next four years. For more information or any query mail at [email protected] An important factor impelling the prospects for growth in this market is the emergence of biosimilars. Unlike generic drugs, which have active pharmaceutical ingredients similar to original drugs, biosimilars are almost identical to their originator biologic compounds. Since biosimilars help to make treatments more accessible to patients and are less expensive than biologics, their sale among the end users is anticipated to increase significantly over the next few years. Segmentation by type of immunotherapy and analysis of the immunotherapy drugs market - mAbs - Vaccines - Immune checkpoint inhibitors - Non-specific immunotherapies During 2015, the mAbs segment dominated this market and accounted for an impressive market share of nearly 61%. The development of new drugs and the entry of new molecules like zanolimumab, elotuzumab, obinutuzumab, and onartuzumab into the market will aid in the growth of this market segment during the forecast period. Geographical segmentation and analysis of the immunotherapy drugs market - Americas - APAC - EMEA The Americas dominated the global market with over 50% market share in 2015. The market is flourishing in this region due to the higher incidences of cancer, infectious diseases, and autoimmune diseases in the US. Additionally, factors such as the high affordability of therapies due to the presence of well-structured reimbursement plans will also spur the prospects for market growth until 2020. Competitive landscape and key vendors The global market for immunotherapy drugs is highly competitive due to the presence of a number of large and small vendors. Many of these vendors have a huge global presence and enter into strategic alliances to aid in the manufacture and marketing of essential drugs. Safety and effectiveness of drugs are key factors, which will give vendors an edge in the marketplace. Key vendors in this market are - AbbVie Amgen Bristol-Myers Squibb F.Hoffmann-La Roche Johnson & Johnson Merck Other prominent vendors are AB Science. Ablynx, Acorda Therapeutics, ADC Therapeutics, Aduro Biotech, Advantagene, Advaxis, Agensys, Agenus, Alder Biopharmaceuticals, AlphaVax, Altor BioScience, Antares Pharma, Antigen Express, Argos Therapeutics, Astellas Pharma, AstraZeneca, AVAX Technologies, Bavarian Nordic, Baxter, Bayer, Biogen, Biotech Pharmaceutical, Biothera, Boehringer Ingelheim, Can-Fite BioPharma, Celgene, Celldex Therapeutics, Celltrion, Cel-Sci, ChemoCentryx, Chugai Pharmaceutical, Coherus BioSciences, CTI BioPharma, CureVac, Daiichi Sankyo, Eisai, Eli Lilly, Fortress Biotech, Galena Biopharma, Genexine, Genmab, Gilead Sciences, GSK, GlobeImmune, Gradalis, Heat Biologics, Hospira, Idera, Inmatics, ImmunoCellular Therapeutics, Immunomedics, ImmuPharma, Immutep, Incyte, Inovio Pharmaceuticals, Intas Pharmaceuticals, Invion, ISA Pharmaceuticals, Janssen Biotech, Juvaris Biotherapeutics, KaloBios Pharmaceuticals, Kyowa Hakko Kirin, Lexicon Pharmaceuticals, MedImmune, Morphotek, Neovii Biotech, Northwest Biotherapeutics, Novartis, NovaRx, Novo Nordisk, OncoMed Pharmaceuticals, Oncothyreon, Oncovir, Opexa Therapeutics, Oxford BioMedica, Pfizer, Prima BioMed, Principia, Progenics, Provectus Biopharmaceuticals, Regeneron, Sandoz, Sanofi, Santarus, Seattle Genetics, Sotio, Spectrum Pharmaceuticals, Takeda, TG Therapeutics, Transgene, UbiVac, UCB, Vaccinex, Vaccinogen, Vaxon Biotech, Vertex Pharmaceuticals, Vical, Vitae Pharmaceuticals, and XBiotech. Key questions answered in the report include - What will the market size and the growth rate be in 2020? - What are the key factors driving the global immunotherapy drugs market? - What are the key market trends impacting the growth of the global immunotherapy drugs market? - What are the challenges to market growth for immunotherapy drugs? - Who are the key vendors in the global immunotherapy drugs market? - What are the market opportunities and threats faced by the vendors in the immunotherapy drugs market? - Trending factors influencing the market shares of the Americas, APAC, and EMEA. - What are the key outcomes of the five forces analysis of the global immunotherapy drugs market? For more information or any query mail at [email protected] Wise Guy Reports is part of the Wise Guy Consultants Pvt. Ltd. and offers premium progressive statistical surveying, market research reports, analysis & forecast data for industries and governments around the globe. Wise Guy Reports features an exhaustive list of market research reports from hundreds of publishers worldwide. We boast a database spanning virtually every market category and an even more comprehensive collection of market research reports under these categories and sub-categories.
News Article | November 21, 2016
SEATTLE, Nov. 21, 2016 /PRNewswire/ -- CTI BioPharma Corp. (CTI) (NASDAQ and MTA: CTIC) today announced that data from the randomized Phase 3 PERSIST-2 clinical trial comparing the investigational agent pacritinib, an oral multikinase inhibitor, with physician-specified best available...
News Article | December 1, 2016
SEATTLE, Dec. 1, 2016 /PRNewswire/ -- CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) today announced the results of a translational pharmacology study comparing biomarker activity profiles for three JAK inhibitors: pacritinib, ruxolitinib and momelotinib, using the BioMAP® Dive...
News Article | February 27, 2017
SEATTLE, Feb. 27, 2017 /PRNewswire/ -- CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) today announced the appointment of Adam Craig, M.D., Ph.D., as President and Chief Executive Officer (CEO) and member of the Board of Directors effective March 20, 2017. Dr. Craig succeeds...
News Article | February 23, 2017
SEATTLE, Feb. 23, 2017 /PRNewswire/ -- CTI BioPharma Corp. (CTI BioPharma) (NASDAQ and MTA: CTIC) today announced that management plans to report its fourth quarter and full year 2016 financial results on Thursday, March 2, 2017, after the close of the U.S. financial markets. Following the...
News Article | March 2, 2017
SEATTLE, March 2, 2017 /PRNewswire/ -- CTI BioPharma Corp. (NASDAQ and MTA: CTIC) today reported financial results for the fourth quarter and full year ended December 31, 2016. "The presentation of detailed results from the Phase 3 PERSIST-2 trial of pacritinib at the ASH Annual...