Attached files
| file | filename |
|---|---|
| 8-K - FORM 8-K - CTI BIOPHARMA CORP | d8k.htm |
Exhibit 99.1
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501 Elliott Ave. W. #400 Seattle, WA 98119 |
T 206.282.7100 F 206.272.4010 |
Cell Therapeutics Provides Monthly Information
at Request of CONSOB
January 28, 2011 Seattle — Cell Therapeutics, Inc. (the “Company” or “CTI”) (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 Unified Financial Act, 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 management and financial situation. However, the Company also directs its Italian shareholders to the Italian language section of its website at www.celltherapeutics.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 U.S. Securities and Exchange (“SEC”) filings and the Listing Prospectus authorized to be published by CONSOB, 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 December 1, 2010 through December 31, 2010 except as otherwise expressly noted.
Provisional financial information as of December 31, 2010 and EBITDA
The following information concerns the Company’s provisional (unaudited) results for the month ended December 31, 2010.
Such financial information represents estimates that are based on assumptions the occurrence of which depends on circumstances relating to the Company and the macroeconomic situation, and which assumptions might or might not occur.
The following table reports the Estimated Indication of a few relevant items referring to the statements of operations for the month ended December 31, 2010:
www.CellTherapeutics.com
Estimated financial data of the Company for the month ended December 31, 2010
The estimated and unaudited financial data of the Company as of December 31, 2010 compared with those for the previous month are shown below (amounts in thousands of U.S. dollars):
| November 30, 2010 | December 31, 2010 | |||||||
| Net revenue |
$ | — | $ | — | ||||
| Operating income (expense) |
$ | (3,452 | ) | $ | (8,427 | ) | ||
| Profit /(Loss) from operations |
$ | (3,452 | ) | $ | (8,427 | ) | ||
| Other income (expenses), net |
$ | (120 | ) | $ | (2,937 | ) | ||
| Preferred Stock: |
||||||||
| -Deemed Dividend |
$ | — | $ | (14,399 | ) | |||
| EBITDA |
$ | (3,572 | ) | $ | (25,763 | ) | ||
| Depreciation and amortization |
$ | (161 | ) | $ | (119 | ) | ||
| Amortization of debt discount and issuance costs |
$ | (10 | ) | $ | (147 | ) | ||
| Interest expense |
$ | (431 | ) | $ | 162 | |||
| Net profit /(loss) attributable to common shareholders |
$ | (4,174 | ) | $ | (25,867 | ) | ||
Estimated Research and Development expenses were $1.6 million and $4.4 million for the months of November 2010 and December 2010, respectively.
Net financial indebtedness
The following table reports the estimated and unaudited net financial indebtedness of the Company as of November 30, 2010 and December 31, 2010, including the separate indication of the total financial needs, regarding debts expiring less than 12 months ahead (current portion). The relevant financial data are compared with those for the previous month (amounts in thousands of U.S. dollars).
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| Net Financial Standing |
November 30, 2010 | December 31, 2010 | ||||||
| Cash and cash equivalents |
$ | 27,878 | $ | 22,649 | ||||
| Long term obligations, current portion |
$ | (831 | ) | $ | (1,717 | ) | ||
| Convertible senior notes |
$ | (10,187 | ) | $ | (22,308 | ) | ||
| Net Financial Standing, current portion |
$ | 16,860 | $ | (1,376 | ) | |||
| Long term obligations, less current portion |
$ | (918 | ) | $ | (4,206 | ) | ||
| Convertible senior notes |
$ | (11,985 | ) | $ | — | |||
| Net Financial Standing, less current portion |
$ | (12,903 | ) | $ | (4,206 | ) | ||
| Net Financial Indebtedness |
$ | 3,957 | $ | (5,582 | ) | |||
The total estimated and unaudited net financial position of the Company as of December 31, 2010 was approximately negative $5,582 (in thousands of U.S. dollars).
The Company’s 7.5% Convertible Senior Notes with a maturity date of April 30, 2011 and 5.75% Convertible Senior Notes with a maturity date of December 15, 2011 come due within the next twelve months.
Outstanding notes and preferred shares
The following table discloses information about the Company’s outstanding convertible senior notes as of December 31, 2010, compared with the same information as of November 30, 2010:
Convertible Notes–December 31, 2010
| Description |
Maturity/ Redemption Date |
Principal/ Aggregated Stated Value Outstanding as of November 30, 2010 |
Number of Common Stock Reserve as of November 30, 2010 |
Principal/ Aggregated Stated Value Outstanding as of December 31, 2010 |
Number of Common Stock Reserve as of December 31, 2010 |
|||||||||||||
| 7.5% Convertible Senior Notes |
30-Apr-11 | $ | 10,250,000 | 122,620 | $ | 10,250,000 | 122,620 | |||||||||||
| 5.75% Convertible Senior Notes |
15-Dec-11 | $ | 10,913,000 | 363,766 | $ | 10,913,000 | 363,766 | |||||||||||
| Totals |
$ | 21,163,000 | 486,386 | $ | 21,163,000 | 486,386 | ||||||||||||
The Company had no outstanding preferred shares as of November 30, 2010 and December 31, 2010.
www.CellTherapeutics.com
Debt Restructuring Program
In December 2010, the Company neither issued any new debt instruments nor bought any debt instruments already issued by the Company. The Company believes it is in compliance with the covenants on each series of its outstanding convertible notes.
Regulatory Matters and Products in Development
Pixantrone
On November 18, 2010, the Company announced that the Marketing Authorization Application (“MAA”) seeking approval for pixantrone for the treatment of adult patients with multiply relapsed or refractory aggressive non-Hodgkin’s lymphoma (“NHL”) was validated and accepted for review by the European Medicines Agency (“EMA”). On December 3, 2010, the Company announced that it had submitted a formal appeal to the Office of New Drugs in the U.S. Food and Drug Administration’s (“FDA”) Center for Drug Evaluation and Research regarding FDA’s decision from earlier this year on the pixantrone New Drug Application (“NDA”) to treat relapsed/refractory aggressive NHL.
Corporate Transactions and Assignment of Assets
With respect to the period from December 1, 2010 through December 31, 2010, the Company has no additional information to disclose to the market.
Exchange Listing Matters
On November 3, 2010, the Company announced that The NASDAQ Stock Market (“NASDAQ”) granted the Company an additional 180 days to regain compliance with NASDAQ’s $1.00 minimum bid price rule under NASDAQ Marketplace Rule 5550(a)(2). The Company may achieve compliance during the 180-day period if the closing bid price of the Company’s common stock, no par value per share (the “Common Stock”), is at least a $1.00 per share for a minimum of ten consecutive business days before May 2, 2011.
Update on Outstanding Shares
The number of shares of the Company’s Common Stock issued and outstanding as of November 30, 2010 and December 31, 2010 was 816,761,099 and 813,751,299, respectively.
During the month of December 2010, the following transactions contributed to the change in the number of shares of outstanding Common Stock:
| • | the issuance of 24,866 shares of Common Stock under the Company’s 2007 Employee Stock Purchase Plan, as amended; and |
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| • | the cancellation of 3,034,666 shares of Common Stock under the Company’s 2007 Equity Incentive Plan, as amended and restated. |
The Company is not aware of any agreement for the resale of its shares of Common Stock on the Mercato Telematico Azionario (MTA) nor of the modalities by means of which shares of Common Stock were or will be resold.
Information about the capacity of the Company to sustain its financial needs
As disclosed in this press release, the Company had approximately $22.6 million in cash and cash equivalents as of December 31, 2010. This amount does not include the proceeds from the Company’s recently announced registered offering (the “Offering”) of up to $25 million of shares of the Company’s Series 8 Non-Convertible Preferred Stock (the “Series 8 Preferred Stock”), warrants to purchase up to 22,563,177 shares of Common Stock (the “Warrants”) and an additional investment right (the “Additional Investment Right”) to purchase up to $25 million of shares of the Company’s Series 9 Convertible Preferred Stock (the “Series 9 Preferred Stock”) to a single life sciences institutional investor (the “Investor”). Prior to the closing of the Offering, the Investor elected to exercise all of the Warrants to purchase 22,563,177 shares of Common Stock and the entire Additional Investment Right to purchase 25,000 shares of Series 9 Preferred Stock (together, the “Exercises”). The Investor also elected to convert the 25,000 shares of Series 9 Preferred Stock into 64,466,219 shares of Common Stock, for a total of 87,029,396 shares of Common Stock issued to the Investor as a result of the Exercises. The exercise price for the Exercises was paid through the issuance by the Investor to the Company of recourse notes fully secured with marketable securities. The Offering closed on January 27, 2011 and the Company received $25 million in gross proceeds upon issuance of 25,000 shares of Series 8 Preferred Stock. As of January 28, 2011, 25,000 shares of the Series 8 Preferred Stock are issued and outstanding.
About Cell Therapeutics, Inc.
Headquartered in Seattle, the Company is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.CellTherapeutics.com.
This press release includes forward-looking statements that involve a number of risks and uncertainties, the outcome of which could materially and/or adversely affect future results and the trading price of the Company’s securities. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with pixantrone in particular, including, without limitation, the potential failure of pixantrone to prove safe and effective for the treatment of relapsed or refractory aggressive NHL and/or other tumors as determined by the FDA and/or the EMA, that the FDA may not accept the Company’s special protocol assessment and/or the proposed design for the protocol of the Company’s clinical trial and/or may request additional clinical trials, that the EMA may not approve the Company’s MAA after review, that the Company may not regain compliance with NASDAQ’s minimum bid price rule by May 2, 2011, that the Company cannot predict the outcome of the formal dispute resolution process, that the Company’s appeal may not be successful, and the
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Company’s ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone. Further risks and uncertainties that the Company continues to have a substantial amount of debt outstanding and the quarterly interest expense associated with the debt is significant, the Company’s operating expenses continue to exceed its net revenues, that the Company may not be able to further reduce its operating expenses, that the Company will continue to need to raise capital to fund its operating expenses and may not be able to raise sufficient amounts to fund its continued operation, and that the information presented herein with respect to the Company’s convertible notes may differ materially from the information presented by the Company with respect to its convertible notes and convertible preferred stock prepared in accordance with U.S. GAAP in its periodic reports on Form 10-K and Form 10-Q, as well as other risks listed or described from time to time in the Company’s most recent filings with the SEC on Forms 10-K, 10-Q and 8-K. Except as required by law, the Company does not intend to update any of the statements in this press release upon further developments.
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Media Contact:
Cell Therapeutics, Inc.
Dan Eramian
T: 206.272.4343
C: 206.854.1200
Lindsey Jesch
T : 206.272.4347
F : 206.272.4434
E: deramian@ctiseattle.com
www.CellTherapeutics.com/press_room
Investors Contact:
Cell Therapeutics, Inc.
Ed Bell
T: 206.272.4345
F: 206.272.4434
E: invest@ctiseattle.com
www.CellTherapeutics.com/investors
www.CellTherapeutics.com