Attached files
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| 8-K - FORM 8-K - CTI BIOPHARMA CORP | d248813d8k.htm |
Exhibit 99.1
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501 Elliott Ave. W. #400 Seattle, WA 98119 |
T 206.312.7100 F 206.272.4010 |
Cell Therapeutics Provides Monthly Information
at Request of CONSOB
October 28, 2011 Seattle — Cell Therapeutics, Inc. (the “Company” or “CTI”) (NASDAQ: CTIC 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 Registration Document 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 September 1, 2011 through September 30, 2011 except as otherwise expressly noted.
Provisional (unaudited) financial information and EBITDA as of September 30, 2011
The following information concerns the Company’s provisional (unaudited) results for the month ended September 30, 2011.
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 unaudited statements of operations for the month ended September 30, 2011:
Estimated financial data of the Company for the month ended September 30, 2011
The estimated and unaudited financial data of the Company as of September 30, 2011 compared with those for the previous month are shown below (amounts in thousands of U.S. dollars):
| August 31, 2011 | September 30, 2011 | |||||||
| Net revenue |
$ | — | $ | — | ||||
| Operating income (expense) |
$ | (4,328 | ) | $ | (5,820 | ) | ||
| Profit(Loss) from operations |
$ | (4,328 | ) | $ | (5,820 | ) | ||
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| Other income (expenses), net |
$ | — | $ | (890 | ) | |||
| Preferred Stock: |
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| -Deemed Dividend |
$ | — | $ | (13,023 | ) | |||
| EBITDA |
$ | (4,328 | ) | $ | (19,733 | ) | ||
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| Depreciation and amortization |
$ | (197 | ) | $ | (308 | ) | ||
| Amortization of debt discount and issuance costs |
$ | (5 | ) | $ | (119 | ) | ||
| Interest expense |
$ | (54 | ) | $ | (96 | ) | ||
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| Net profit /(loss) attributable to common shareholders |
$ | (4,584 | ) | $ | (20,256 | ) | ||
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Estimated research and development expenses were $2.8 million for the month August 2011 and $2.7 million for the month September 2011.
Estimated Net Financial Standing
The following table reports the estimated and unaudited net financial standing of the Company as of August 31, 2011 and September 30, 2011, including the separate indication of the total estimated financial needs, regarding debts expiring less than 12 months ahead (current portion). The relevant estimated financial data are compared with those for the previous month (amounts in thousands of U.S. dollars).
| Estimated Net Financial Standing |
August 31, 2011 | September 30, 2011 | ||||||
| Cash and cash equivalents |
$ | 49,779 | $ | 45,212 | ||||
| Long term obligations, current portion |
$ | (1,640 | ) | $ | (1,395 | ) | ||
| Convertible senior notes |
$ | (12,314 | ) | $ | (12,429 | ) | ||
| Estimated Net Financial Standing current portion |
$ | 35,825 | $ | 31,388 | ||||
| Long term obligations, less current portion |
$ | (3,408 | ) | $ | (3,088 | ) | ||
| Net financial standing, less current portion |
$ | (3,408 | ) | $ | (3,088 | ) | ||
| Estimated Net Financial Standing |
$ | 32,417 | $ | 28,300 | ||||
The total estimated and unaudited net financial standing of the Company as of September 30, 2011 was approximately $28,300 (in thousands of U.S. dollars).
The Company’s 5.75% Convertible Senior Notes with a maturity date of December 15, 2011 come due within the next 12 months.
The Company had no debt that matured during the month of September 2011.
Outstanding notes
The following tables disclose information about the Company’s outstanding convertible senior notes as of September 30, 2011, compared with the same information as of August 31, 2011:
Convertible Notes–September 30, 2011
| Description |
Maturity / Redemption Date |
Principal/ Aggregated Stated Value Outstanding as of August 31, 2011 ($) |
Number of Shares of Common Stock Reserved as of August 31, 2011 |
Principal/ Aggregated Stated Value Outstanding as of September 30, 2011 ($) |
Number of Shares of Common Stock Reserved as of September 30, 2011 |
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| 5.75% Convertible Senior Notes |
15-Dec- 11 | 10,913,000 | 60,627 | 10,913,000 | 60,627 | |||||||||||||||
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| Totals |
10,913,000 | 60,627 | 10,913,000 | 60,627 | ||||||||||||||||
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Debt Restructuring Program
In September 2011, 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 its outstanding convertible notes.
Regulatory Matters and Products in Development
Pixantrone
On September 28, 2011, the Company announced that a second independent radiology assessment of response and progression endpoint data from the Company’s PIX301 clinical trial of pixantrone were achieved with statistical significance. The Company believes this assessment confirmed the statistical robustness of the PIX301 efficacy data that was previously submitted by the Company to the U.S. Food and Drug Administration (“FDA”) in the Company’s new drug application (“NDA”) for pixantrone. This second independent assessment was recommended by the FDA’s Office of New Drugs (“OND”) as part of the Company’s appeal of the Complete Response Letter for the NDA, which the Company received from the FDA’s Office of Oncology Drug Products. On October 25, 2011, the Company announced the resubmission of the NDA to the FDA’s Division of Oncology Drug Products (the “DODP”) for accelerated approval to treat relapsed or refractory aggressive non-Hodgkin’s lymphoma (“NHL”) in patients who failed two or more lines of prior therapy.
Corporate Transactions and Assignment of Assets
With respect to the period from September 1, 2011 through September 30, 2011, the Company has no additional information to disclose to the market.
Exchange Listing Matters
With respect to the period from September 1, 2011 through September 30, 2011, the Company has no additional information to disclose to the market.
Update on Outstanding Shares of Common Stock
The number of shares outstanding of the Company’s common stock, no par value (the “Common Stock”), issued and outstanding as of August 31, 2011 and September 30, 2011 was 192,875,488 and 192,801,179, respectively.
During the month of September 2011, the following transactions contributed to the change in the number of shares of the Company’s outstanding Common Stock:
| • | the issuance of 18,000 shares of Common Stock under the Company’s 2007 Equity Incentive Plan, as amended and restated (the “Equity Plan”); and |
| • | the cancellation of 92,309 shares of Common Stock under the Equity Plan. |
The Company is not aware of any agreement for the resale of its shares of Common Stock on the 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 $45.2 million in cash and cash equivalents as of September 30, 2011, which does not include approximately $8.2 million in other proceeds received in October 2011 in connection with the settlement of a lawsuit.
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, relapsed/refractory diffuse large B-cell lymphoma and/or other tumors as determined by the FDA and/or the European Medicines Agency (the “EMA”), that the Company cannot predict or guarantee the pace or geography of enrollment of its clinical trials or the total number of patients enrolled, that the FDA may request additional clinical trials, that the EMA may not approve the MAA after review, that accelerated approval by the FDA of pixantrone may not be possible or occur, that the Company may not be able to address satisfactorily the two key matters raised by the OND or other matters raised by the FDA, the OND, and/or the DODP, that the Company’s interpretation of the guidance provided by the FDA, the OND and/or the DODP may be different than the intent of the FDA, OND and/or the DODP, that the
FDA, OND and/or the DODP may change its guidance, that the PIX301 study may not be deemed successful, that upon a re-review or resubmission of the NDA, that the FDA may find pixantrone to not be safe and/or effective, that the PIX301 study may still be deemed to be a failed study, that if the Company conducts an additional clinical trial, it may not demonstrate the safety and effectiveness of pixantrone, that the Company may not be able to provide satisfactory information in response to the FDA’s Complete Response Letter, that the FDA may not complete the review of the NDA within six months of resubmission, that the Company may not obtain an FDA action date by April 2012, that the Company may not obtain approval of the NDA from the FDA in the first half of 2012, that the Company cannot guarantee that it will maintain compliance with the NASDAQ listing standards, the risk that the Company may not be able to continue to raise capital as needed to fund its operations, competitive factors, technological developments, and costs of developing, producing and selling pixantrone. Further risks and uncertainties include 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 and non-convertible preferred stock may differ materially from the information presented by the Company with respect to its convertible notes and non-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
E: deramian@ctiseattle.com
www.CellTherapeutics.com/press_room
Investors Contact:
Cell Therapeutics, Inc.
Ed Bell
T: 206.272.4345
F: 206.272.4434
Lindsey Jesch Logan
T : 206.272.4347
F : 206.272.4434
E: invest@ctiseattle.com
www.CellTherapeutics.com/investors