EWING, N.J., March 24, 2014 (GLOBE NEWSWIRE) -- Celator Pharmaceuticals, Inc. (Nasdaq:CPXX), a pharmaceutical company developing new and more effective therapies to treat cancer, today reported business highlights and financial results for the fourth quarter and year ended December 31, 2013.
"2013 was a transformative year for Celator, attaining important milestones as we continue to leverage our CombiPlex® platform to introduce an entirely new medical standard for combining cancer therapies," said Scott Jackson, chief executive officer of Celator. "With the completion of a private placement financing which raised $29.4 million of net proceeds in the second quarter of 2013, we were able to continue advancing our lead product, CPX-351, towards approval. We have surpassed over 50% enrollment in our pivotal Phase 3 study of CPX-351 in patients with secondary acute myeloid leukemia (AML), and this study remains on track to complete enrollment before year end. In addition, several investigator-initiated studies of CPX-351 are ongoing in important patient populations beyond secondary AML. Lastly, our stock began trading on the NASDAQ Capital Market in the fourth quarter, representing an important milestone in our success as a public company."
Fourth Quarter 2013 and Recent Business Highlights:
- In January, patient enrollment in the Phase 3 study of the Company's lead investigational product, CPX-351 (cytarabine:daunorubicin) Liposome Injection, in patients 60-75 years of age with high-risk (secondary) AML, reached 50% of the study's planned enrollment of 300 patients. Patient enrollment is on track to be completed by year-end 2014. In December, Celator announced that the independent Data and Safety Monitoring Board for this Phase 3 clinical study recommended that the study continue as planned and without any modifications.
- In January, Celator received approximately $1.4 million in non-dilutive financing through New Jersey's Technology Business Tax Certificate Transfer Program. This program enables qualifying companies to turn their tax losses and credits into cash.
- Celator common stock was approved for listing on the NASDAQ Capital Market and commenced trading on NASDAQ on November 11, 2013. This followed Celator common stock being approved for initial quotation and trading on September 12, 2013 on the OTC Bulletin Board (OTCBB) and the OTC Market Group's OTC Link quotation system.
- Celator expanded its leadership team with the additions of Derek Miller as Chief Business Officer and Les Mintzmyer as Vice President, Manufacturing and Technical Operations. In addition, Joseph Lobacki, former Senior Vice President and Chief Commercial Officer at Micromet, was appointed to the Celator Board of Directors.
Financial Highlights:
- Cash Position: Cash and cash equivalents as of December 31, 2013 were $23.6 million, compared to $9.6 million as of December 31, 2012. The net increase of $14.0 million was primarily due to the April 2013 private placement, which raised approximately $29.4 million, less cash used in operating activities of approximately $12.5 million and for repayment of $3.0 million of debt that was outstanding as of December 31, 2012. As of December 31, 2013, Celator had no debt outstanding.
- R&D Expenses: Research and development expenses increased to $3.4 million and $9.4 million for the three months and year ended December 31, 2013, respectively, from $1.6 million and $4.9 million for the same periods in 2012. The increase in R&D expenses was largely due to an increase in clinical and regulatory activities during the year related to the Phase 3 study of CPX-351.
- G&A Expenses: General and administrative expenses increased to $1.5 million and $5.4 million for the three months and year ended December 31, 2013, respectively, from $1.3 million and $4.1 million for the same periods in 2012. The increase was primarily attributable to an increase in compensation and stock option expenses, Board of Directors and Scientific Advisory Board expenses and recruitment expenses.
- Net Loss: Net loss was $3.4 million and $20.8 million for the three months and year ended December 31, 2013, respectively, as compared to $0.5 million and $10.9 million for the same periods in 2012.
Conference Call Information:
Celator will host a conference call and live audio webcast today at 4:30 p.m. ET to discuss the fourth quarter and year-end 2013 financial results. To participate in the conference call, please dial (877) 303-6316 (domestic) or (650) 521-5176 (international) and refer to conference ID 16121793. The live webcast of the call can be accessed in the Investors section of the Company's website at www.celatorpharma.com. An archived webcast will be available on the Company's website beginning approximately two hours after the event.
About Celator Pharmaceuticals, Inc.
Celator Pharmaceuticals, Inc., with locations in Ewing, N.J., and Vancouver, B.C., is a pharmaceutical company developing new and more effective therapies to treat cancer. CombiPlex®, the company's proprietary drug ratio technology platform, represents a novel approach that identifies molar ratios of drugs that will deliver a synergistic benefit, and locks the desired ratio in a nano-scale drug delivery vehicle that maintains the ratio in patients with the goal of improving clinical outcomes. The company pipeline includes two clinical stage products, CPX-351 (a liposomal formulation of cytarabine:daunorubicin) for the treatment of acute myeloid leukemia and CPX-1 (a liposomal formulation of irinotecan:floxuridine) for the treatment of colorectal cancer; and preclinical stage product candidates, including CPX-571 (a liposomal formulation of irinotecan:cisplatin), and CPX-8, a hydrophobic docetaxel prodrug nanoparticle (HDPN) formulation being studied by the National Cancer Institute's Nanotechnology Characterization Laboratory. For more information, please visit the company's website at www.celatorpharma.com. Information on ongoing trials is available at www.clinicaltrials.gov.
Forward-Looking Statements:
To the extent that statements contained in this press release are not descriptions of historical facts regarding Celator, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "anticipate," "estimate," "intend," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. Examples of forward-looking statements contained in this press release include, among others, statements regarding whether enrollment in our Phase 3 clinical study of CPX-351 will continue on schedule, the safety, potential efficacy and therapeutic potential of CPX-351, whether clinical results for CPX-351 obtained to date will be predictive of future clinical study results, and our expectations regarding the trading of our common stock. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our clinical development programs, future results, working capital performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the conduct of future clinical studies, enrollment in clinical studies, availability of data from ongoing clinical studies and other matters that could affect the commercial potential of our drug candidates, our ability to raise capital and the trading of our common stock. Celator undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the company in general, see Celator's Form 10-K for the year ended December 31, 2013 and other filings by the company with the U.S. Securities and Exchange Commission.
| Celator Pharmaceuticals, Inc. and Subsidiaries | ||
| (A development stage company) | ||
| Consolidated Balance Sheets | ||
| (Unaudited) | ||
| December 31 | ||
| 2013 | 2012 | |
| Assets | ||
| Current assets: | ||
| Cash and cash equivalents | $ 23,589,516 | $ 9,648,008 |
| Restricted cash | 287,657 | 40,205 |
| Other receivables | 1,417,313 | 2,000,357 |
| Prepaid expenses and deposits | 491,465 | 148,275 |
| Assets held for sale | 74,086 | 251,269 |
| Other current assets | 468,389 | -- |
| Total current assets | 26,328,426 | 12,088,114 |
| Property and equipment, net | 1,138,579 | 1,245,025 |
| Other assets | 5,745 | 105,805 |
| Total assets | $ 27,472,750 | $ 13,438,944 |
| Liabilities | ||
| Current liabilities: | ||
| Accounts payable | $ 1,193,148 | $ 699,858 |
| Accrued liabilities | 1,630,809 | 1,194,998 |
| Current portion of deferred revenue | 542,986 | 615,384 |
| Current portion of loans | -- | 1,200,000 |
| Total current liabilities | 3,366,943 | 3,710,240 |
| Deferred revenue | 588,236 | 1,076,924 |
| Deferred rent | 53,084 | -- |
| Loans payable | -- | 1,800,000 |
| Total liabilities | 4,008,263 | 6,587,164 |
| Stockholders' equity | ||
| Common stock | ||
| Authorized 255,000,000 shares, par value $0.001 | ||
|
Issued and outstanding 26,035,596 and 13,673,160 shares as of December 31, 2013 and 2012, respectively |
26,036 | 13,673 |
| Warrants | 1,083,193 | 1,083,193 |
| Additional paid-in capital | 155,953,894 | 118,509,395 |
| Accumulated other comprehensive loss | (1,133,266) | (1,133,266) |
| Deficit accumulated during the development stage | (132,465,370) | (111,621,215) |
| Total stockholders' equity | 23,464,487 | 6,851,780 |
| Total liabilities and stockholders' equity | $ 27,472,750 | $ 13,438,944 |
| Celator Pharmaceuticals, Inc. and Subsidiaries | ||||
| (A development stage company) | ||||
| Consolidated Statement of Loss and Comprehensive Loss | ||||
| (Unaudited) | ||||
| Three months ended | Year ended | |||
| December 31, | December 31, | |||
| 2013 | 2012 | 2013 | 2012 | |
| Expenses | ||||
| Research and development | $ 3,427,190 | $ 1,573,032 | $ 9,423,056 | $ 4,868,734 |
| Leukemia & Lymphoma Society funding | (135,747) | (1,153,846) | (561,086) | (1,442,692) |
| Research collaboration income | -- | -- | -- | (19,440) |
| General and administrative | 1,505,623 | 1,253,351 | 5,427,707 | 4,098,446 |
| Loss on disposal of property and equipment | -- | 32,725 | 126,633 | 83,077 |
| Amortization and depreciation | 49,452 | 158,965 | 197,743 | 411,621 |
| Operating loss | (4,846,518) | (1,864,227) | (14,614,053) | (7,999,746) |
| Other income (expenses) | ||||
| Foreign exchange (loss) gain | (9,799) | 913 | (31,028) | (11,500) |
| Interest and miscellaneous income | 2,532 | 607 | 9,092 | 2,734 |
| Non-cash derivative instrument charge | -- | -- | (7,473,108) | -- |
| Interest expense | (335) | (42,804) | (147,360) | (4,263,774) |
| Loss before income taxes | (4,854,120) | (1,905,511) | (22,256,457) | (12,272,286) |
| Income tax benefit | 1,412,302 | 1,363,559 | 1,412,302 | 1,363,559 |
| Net loss attributable to common stockholders | $ (3,441,818) | $ (541,952) | $ (20,844,155) | $ (10,908,727) |
| Net loss per share | ||||
| Basic and diluted | $ (0.13) | $ (0.04) | $ (0.95) | $ (0.88) |
| Weighted average of common shares outstanding | ||||
| Basic and diluted | 26,031,974 | 13,639,664 | 22,000,476 | 12,361,163 |