Form 8-K CTI BIOPHARMA CORP For: Sep 30

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): September 30, 2015

 

CTI BIOPHARMA CORP.

(Exact name of registrant as specified in its charter)

 

 

3101 Western Avenue, Suite 600

Seattle, Washington 98121

(Address of principal executive offices)

Registrant’s telephone number, including area code: (206) 282-7100

Not applicable

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

 

 

 

 

 

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Item 2.02. Results of Operations and Financial Condition.

The information provided pursuant to this Item 2.02 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any filing or other document filed by the Company pursuant to the Exchange Act or the Securities Act of 1933, as amended (the “Securities Act”), except as shall be expressly set forth by specific reference in such filing or document. The information provided pursuant to this Item 2.02 shall instead be deemed “furnished.”

Pursuant to a request from CONSOB, the Italian securities regulatory authority, CTI BioPharma Corp. (the “Company”) issued a press release in Italy on September 30, 2015 providing certain requested financial information for the month ended August 31, 2015 and other information (the “Monthly Italian Press Release”). An English translation of the Monthly Italian Press Release is attached as Exhibit 99.1 and incorporated by reference herein. The financial information contained in the Monthly Italian Press Release was prepared at the instruction of CONSOB pursuant to Section 114, paragraph 5, of the Italian Legislative Decree no. 58/98. In communications with CONSOB about its request that certain estimated and unaudited financial information be disclosed by the Company, the Company advised CONSOB that the information is not otherwise required to be disclosed in the United States by public companies under the U.S. securities laws. The Company further advised CONSOB that any such financial information has not been reviewed or audited by the Company’s independent auditors as such reviews only occur on a quarterly basis in connection with the requirements of quarterly reports on Form 10-Q filed with the U.S. Securities and Exchange Commission (the “SEC”), which reports are prepared for the first three quarters of the year, and in connection with the annual audit of the Company’s year-end financial statements, which is included in the Company’s annual reports on Form 10-K filed with the SEC. The Company further advised CONSOB that any such financial information could not be prepared in accordance with U.S. Generally Accepted Accounting Principles (“U.S. GAAP”), as promulgated by the Financial Accounting Standards Board.

In addition, the financial information contained in the Monthly Italian Press Release does not conform to U.S. GAAP because the Company has not concluded its consideration of authoritative literature and guidelines. Accordingly, the data presented in the information should not be relied on for investment purposes. Moreover, the information may deviate from values as reported in accordance with U.S. GAAP in the Company’s reviewed quarterly financial statements and audited year-end financial statements.

Further, the information contained in the Monthly Italian Press Release may not be consistent with quarterly or annual financial information presented in accordance with U.S. GAAP. This information is being provided solely at the instruction of CONSOB, is not used by management to evaluate the Company’s operating performance and is not presented as or intended to be an alternative to U.S. GAAP financial information. The Company is unable to reconcile this information to the most directly comparable U.S. GAAP financial measures, because no such comparable U.S. GAAP financial measures exist or are available at the time as the Company’s year-end review and audit process has not yet been completed.

Investors are urged to refer to the Company’s financial statements prepared in accordance with U.S. GAAP and the risk factors listed or described from time to time in the Company’s filings with the SEC including, without limitation, the Company’s filings on Forms 10-K, 10-Q, and 8-K.

 

Item 7.01. Regulation FD Disclosure.

The information provided pursuant to this Item 7.01 shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, and shall not be incorporated by reference into any filing or other document filed by the Company pursuant to the Exchange Act or the Securities Act except as shall be expressly set forth by specific reference in such filing or document. The information provided pursuant to this Item 7.01 shall instead be deemed “furnished.”

On September 30, 2015, the Company issued the Monthly Italian Press Release containing the information requested by CONSOB discussed above. An English translation of the Monthly Italian Press Release is attached hereto as Exhibit 99.1.

 

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits

 

 

 

 

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SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

 

 

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EXHIBIT INDEX

 

 

Exhibit 99.1

CTI BioPharma Corp. Provides Monthly Information at Request of CONSOB

SEATTLE, Wash., September 30, 2015-CTI BioPharma Corp. (“CTI”, the “Company” or “CTI Parent Company”) (NASDAQ and MTA: CTIC) is providing the information herein pursuant to a request from the Italian securities regulatory authority, CONSOB, pursuant to Article 114, Section 5 of the Italian Legislative Decree no. 58/98, that the Company issue at the end of each month a press release providing a monthly update of certain information relating to the Company’s financial situation. However, the Company also directs its Italian shareholders to the Italian language section of its website at www.ctibiopharma.com/italiano, where more complete information about the Company and its products and operations, including press releases issued by the Company, as well as the Company’s filings with the U.S. Securities and Exchange Commission (“SEC”), can be found. The information provided below is qualified in its entirety by reference to such information. Please note that all the information disclosed in this press release primarily refers to the period August 1, 2015 through August 31, 2015, except as otherwise expressly noted.

Provisional Estimated and Unaudited Net Financial Position of CTI Parent Company

The following table reports the estimated and unaudited net financial standing of CTI Parent Company as of August 31, 2015, including a separate indication of the total estimated financial amount of bank debt expiring less than 12 months ahead (current portion).

 

*The long-term debt includes $32 million associated with the previously reported advance of two development milestone payments under our collaboration arrangement with Baxalta Incorporated and its affiliates related to pacritinib, as disclosed in a press release issued June 10, 2015. In the event that the respective milestone is achieved in accordance with the terms of the advance arrangement, the advance would cease to be accounted for as long-term debt and would thereupon be accounted for as revenue.

The total estimated and unaudited net financial standing of CTI Parent Company as of August 31, 2015 was negative $18.9 million.

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Provisional and Unaudited Estimated Net Financial Position of CTI Consolidated Group

The following table reports the estimated and unaudited net financial standing of CTI Consolidated Group as of August 31, 2015, including a separate indication of the total estimated financial amount of bank debt expiring less than 12 months ahead (current portion).

 

*The long-term debt includes $32 million associated with the previously reported advance of two development milestone payments under our collaboration arrangement with Baxalta Incorporated and its affiliates related to pacritinib, as disclosed in a press release issued June 10, 2015. In the event that the respective milestone is achieved in accordance with the terms of the advance arrangement, the advance would cease to be accounted for as long-term debt and would thereupon be accounted for as revenue.

The total estimated and unaudited net financial standing of CTI Consolidated Group as of August 31, 2015, was negative $17.8 million.

CTI Parent Company trade payables outstanding for greater than 30 days were approximately $9.5 million as of August 31, 2015.

CTI Consolidated Group trade payables outstanding for greater than 30 days were approximately $11.9 million as of August 31, 2015.

During August 2015, there were solicitations for payment only within the ordinary course of business and there were no injunctions or suspensions of supply relationships that affected the course of normal business.

Except as disclosed herein, as of August 31, 2015, there were no amounts overdue of a financial or tax nature, or amounts overdue to social security institutions or overdue to employees.

During August 2015, there were no transactions with related parties other than those included in the table below and transactions between entities within CTI Consolidated Group. Intercompany transactions are considered ordinary operating activities and are eliminated in consolidation. During August 2015, there were no atypical or unusual intercompany transactions between entities within CTI Consolidated Group to report. The following table reports related party transactions including key management personnel compensation for their service to the applicable entity within CTI Consolidated Group as of August 31, 2015 and for the one month ended August 31, 2015, (as a percentage of the applicable category for CTI Consolidated Group):

 

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During the month of August 2015, the Company’s common stock, no par value (the “Common Stock”), outstanding increased by 62,012 shares. As a result, the number of issued and outstanding shares of Common Stock as of August 31, 2015 was 180,721,087.

 

About CTI BioPharma

 

CTI BioPharma Corp. (NASDAQ and MTA: CTIC) 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. The Company has a commercial presence in Europe and a late-stage development pipeline, including pacritinib, CTI BioPharma’s lead product candidate, which is currently being studied in a Phase 3 program for the treatment of patients with myelofibrosis. CTI BioPharma is headquartered in Seattle, Washington, with offices in London and Milan under the name CTI Life Sciences Limited. For additional information and to sign up for email alerts and get RSS feeds, please visit www.ctibiopharma.com.

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’s securities. Such statements include, but are not limited to, statements regarding estimated and unaudited monthly financial statements, any potential attainment of the milestones associated with the advance under our collaboration arrangement with Baxalta Incorporated and its affiliates and any corresponding recognition of revenue, and the development of CTI in general. 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 and its product and product candidate portfolio in particular including, among others, risks associated with the following: that CTI cannot predict or guarantee the pace or geography of enrollment of its clinical trials, that CTI cannot predict or guarantee the commencement or outcome of preclinical and clinical studies, that CTI may not obtain reimbursement for PIXUVRI in the various applicable countries, that the conditional marketing authorization for PIXUVRI may be withdrawn or may be subject to additional conditions, that CTI may not obtain favorable determinations by other regulatory, patent and administrative governmental authorities, risks related to the costs of developing, producing and selling, as applicable, PIXUVRI, pacritinib, and CTI’s other product candidates, and other risks, including, without limitation, competitive factors, technological developments, that CTI’s operating expenses continue to exceed its net revenues, that CTI may not be able to sustain its current cost controls or further reduce its operating expenses, that CTI may not achieve previously announced goals and objectives as or when projected, that CTI’s average net operating burn rate may increase, and that CTI 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’s most recent filings with the SEC on Forms 10-K, 10-Q and 8-K.  Except as required by law, CTI does not intend to update any of the statements in this press release upon further developments.

Source: CTI BioPharma Corp.

Contacts:

 

CTI BioPharma Corp.

Monique Greer

+1 206-272-4343

[email protected]

 

Ed Bell

+1 206-282-7100

[email protected]

 

 

 

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