CTI BioPharma Reports Fourth Quarter and Full Year 2017 Financial Results

GAAP operating loss for the fourth quarter and twelve months ended December 31, 2017, was $13.7 million and $39.5 million, respectively, compared to GAAP operating loss of $5.6 million and $49.2 million for the respective periods in 2016. Non-GAAP operating loss, which excludes non-cash share-based compensation expense, for the fourth quarter and twelve months ended December 31, 2017 was $12.3 million and $33.8 million, respectively, compared to non-GAAP operating loss of $3.5million and $35.8 million for the respective periods in 2016. Non-cash share-based compensation expense for the fourth quarter and twelve months ended December 31, 2017, was $1.4 million and $5.7 million, respectively, compared to $2.1 million and $13.3 million for the respective periods in 2016. The decrease in operating loss for the fourth quarter and twelve months of 2017 was due to a significant decrease in research and development and selling, general and administrative expenses primarily related to a decrease in pacritinib development costs as a result of the completion of the Phase 3 clinical studies in 2017 and a decrease in expenses for the manufacture of pacritinib and personnel costs. 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 loss for the fourth quarter of 2017 was $14.3 million, or ($0.33) per share, compared to a net loss of $6.4 million, or ($0.23) per share, for the same period in 2016. Net loss for the twelve months ended December 31, 2017, was $45.0 million, or ($1.24) per share, compared to a net loss of $52.0 million, or ($1.86) per share, for the same period in 2016.

As of December 31, 2017, cash, cash equivalents and restricted cash totaled $43.2 million, compared to $44.0 million at December 31, 2016.

Conference Call Information

CTI BioPharma management will host a conference call to review its fourth quarter and full year 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. CET. Participants can access the call at 1-800-289-0517 (domestic) or + +1 323-994-2084 (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 2516357. The telephone replay will be available until March 14, 2018.

About CTI BioPharma Corp.

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.

Non-GAAP Financial Measures

CTI BioPharma has provided in this press release the historical non-GAAP financial measure of operating loss, excluding non-cash share-based compensation expense, for the fourth quarter and twelve months ended December 31, 2017 and December 31, 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 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 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 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.

Forward-Looking Statements

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, expectations with respect to the timing of data and the related analyses, expectations with respect to the timing of regulatory actions,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 2018 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.

CTI BioPharma Investor Contacts:
Tricia Truehart
+1 646 378 2953
ttruehart@troutgroup.com

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,
	2017				2016				2017				2016
Revenues:
Product sales, net	$	—			$	1,015			$	853			$	4,127
License and contract revenue	462				8,121				24,293				53,278
Total revenues	462				9,136				25,146				57,405
Operating costs and expenses:
Cost of product sold	84				864				364				1,377
Research and development	7,098				9,702				32,866				64,961
Selling, general and administrative	6,983				9,205				31,435				45,306
Other operating income	—				(5,077)				—				(5,077)
Total operating costs and expenses, net	14,165				14,694				64,665				106,567
Loss from operations	(13,703)				(5,558)				(39,519)				(49,162)
Non-operating income (expense):
Interest expense	(393)				(589)				(1,872)				(2,614)
Amortization of debt discount and issuance costs	(50)				(37)				(163)				(214)
Foreign exchange gain (loss)	42				(377) Werbung Mehr Nachrichten zur CTI BioPharma Aktie kostenlos abonnieren E-Mail-Adresse Bitte überprüfe deine die E-Mail-Adresse. Benachrichtigungen von ARIVA.DE (Mit der Bestellung akzeptierst du die Datenschutzhinweise) -1 Vielen Dank, dass du dich für unseren Newsletter angemeldet hast. Du erhältst in Kürze eine E-Mail mit einem Aktivierungslink. Hinweis: ARIVA.DE veröffentlicht in dieser Rubrik Analysen, Kolumnen und Nachrichten aus verschiedenen Quellen. Die ARIVA.DE AG ist nicht verantwortlich für Inhalte, die erkennbar von Dritten in den „News“-Bereich dieser Webseite eingestellt worden sind, und macht sich diese nicht zu Eigen. Diese Inhalte sind insbesondere durch eine entsprechende „von“-Kennzeichnung unterhalb der Artikelüberschrift und/oder durch den Link „Um den vollständigen Artikel zu lesen, klicken Sie bitte hier.“ erkennbar; verantwortlich für diese Inhalte ist allein der genannte Dritte. Andere Nutzer interessierten sich auch für folgende News 19.04.24 - PR Newswire Capital Gearing Trust Plc - Transaction in Own Shares 19.04.24 - PR Newswire Rightmove Plc - Transaction in Own Shares 19.04.24 - PR Newswire Samson Rock Capital LLP - Form 8.3 - Mattioli Woods plc Auf zur INVEST am 26.+ 27.04.2024    Foto: Landesmesse Stuttgart GmbH - Jetzt kostenloses Ticket sichern! weiterlesen» Anzeige wo-site-teaser-box-16688_site-teaser-box_2024-04-17_09%253A00%253A00_2024-04-22_09%253A00%253A59