EWING, N.J., Aug. 7, 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 second quarter ended June 30, 2014.
"In the second quarter, we continued to make progress with our pivotal Phase 3 clinical study of CPX-351 in elderly patients with high-risk (secondary) acute myeloid leukemia (AML), as well as with investigator-initiated studies of CPX-351 in other important patient populations," said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals. "We recently announced that our Phase 3 pivotal study has surpassed 80% of our target enrollment and received another favorable recommendation from the study's independent Data and Safety Monitoring Board, keeping us on track to report initial data on induction response rate in the second quarter of 2015 and overall survival data in the first quarter of 2016. At our Analyst Day meeting in July, in addition to updates on CPX-351, we communicated our plan to broaden the application of our proprietary CombiPlex® platform by applying the technology to molecularly targeted therapies, and we expect to have additional information from these programs in 2015. We also secured additional working capital which extends our operating runway and will provide funding to enable us to continue building our pipeline."
Second Quarter 2014 and Recent Business Highlights:
CPX-351:
- In July, Celator announced that patient enrollment in its Phase 3 study of CPX-351 in patients 60-75 years of age with high-risk (secondary) AML surpassed 80% of the study's planned enrollment of 300 patients. Patient enrollment is currently on track to be completed in the fourth quarter of 2014.
- In June, Celator announced that the independent Data and Safety Monitoring Board for its Phase 3 study of CPX-351 recommended that the study continue as planned without any modifications. The DSMB assessment was based on a pre-planned safety analysis on the first 150 randomized patients included in the study with a minimum of 60 days of follow-up.
- In May, Celator announced the publication in Blood, the official journal of the American Society of Hematology, of its Phase 2 study evaluating CPX-351 in newly diagnosed older patients with AML. The study results support Celator's Phase 3 study of CPX-351 as a first-line therapy in older patients with secondary AML.
Technology Platforms:
- In July, Celator announced its plans to advance the CombiPlex® technology platform and widen its application to include molecularly targeted therapies. Data from these new programs are expected by the third quarter of 2015.
Corporate:
- Celator was added to the Russell MicroCap Index® on June 27, 2014 as part of Russell Investments' annual reconstitution of its comprehensive set of U.S. and global equity indexes.
- In May, Celator announced that it entered into a loan agreement with Hercules Technology Growth Capital, Inc. providing access to a term loan of up to $15 million, of which $10 million was funded at closing and $5 million can be drawn down at the Company's option at any time between December 15, 2014 and March 31, 2015.
Financial Highlights:
- Cash Position: Cash and cash equivalents as of June 30, 2014 were $24.9 million, compared to $20.8 million as of March 31, 2014.
- R&D Expenses: Research and development expenses increased to $2.9 million for the three months ended June 30, 2014 from $2.0 million for the same period in 2013. The increase in R&D expenses was largely due to manufacturing, clinical and regulatory activities related to the Phase 3 study of CPX-351 and an increase in compensation and stock option expenses.
- G&A Expenses: General and administrative expenses increased to $1.7 million for the three months ended June 30, 2014, from $1.1 million for the same period in 2013. The increase was primarily attributable to costs associated with commercial and strategic planning and investor relations and an increase in compensation and stock option expenses.
- Operating Loss: Net loss was $4.8 million for the three months ended June 30, 2014, compared to $4.0 million for the same period in 2013.
Conference Call Information:
Celator will host a conference call and live audio webcast today at 4:30 p.m. ET to report second quarter 2014 financial results. To participate in the conference call, please dial (877) 303-6316 (domestic) or (650) 521-5176 (international) and refer to conference ID 82133160. 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 lead product, CPX-351 (a liposomal formulation of cytarabine:daunorubicin) for the treatment of acute myeloid leukemia; CPX-1 (a liposomal formulation of irinotecan:floxuridine) for the treatment of colorectal cancer; a preclinical stage product candidate, CPX-8 (a hydrophobic docetaxel prodrug nanoparticle formulation) being studied by the National Cancer Institute's Nanotechnology Characterization Laboratory; and a program exploring novel combinations of existing drugs, including targeted therapies.
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, our expectations regarding expanding our pipeline and advancing our CombiPlex platform and our expectation regarding the sufficiency of our working capital. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our pre-clinical and clinical development programs, availability of data and other future results, working capital requirements, 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, and Subsidiaries | ||
| Consolidated Balance Sheets | ||
| (Unaudited) | ||
| June 30, 2014 | December 31, 2013 | |
| Assets | ||
| Current assets: | ||
| Cash and cash equivalents | $ 24,924,518 | $ 23,589,516 |
| Restricted cash | 287,562 | 287,657 |
| Other receivables | 3,328 | 1,417,313 |
| Prepaid expenses and deposits | 599,021 | 491,465 |
| Assets held for sale | 74,086 | 74,086 |
| Other current assets | 879,056 | 468,389 |
| Total current assets | 26,767,571 | 26,328,426 |
| Property and equipment, net | 1,046,486 | 1,138,579 |
| Other assets | 653,299 | 5,745 |
| Total assets | $ 28,467,356 | $ 27,472,750 |
| Liabilities | ||
| Current liabilities: | ||
| Current portion of long-term debt | $ 282,253 | $ -- |
| Accounts payable | 525,400 | 1,193,148 |
| Accrued liabilities | 1,545,943 | 1,630,809 |
| Current portion of deferred revenue | 542,986 | 542,986 |
| Total current liabilities | 2,896,582 | 3,366,943 |
| Long-term debt | 9,744,407 | -- |
| Deferred revenue | 316,743 | 588,236 |
| Deferred rent | 49,844 | 53,084 |
| Total liabilities | $ 13,007,576 | $ 4,008,263 |
| Stockholders' equity | ||
| Preferred stock | ||
| Authorized 20,000,000 shares, par value $0.001 | -- | -- |
| Common stock | ||
| Authorized 200,000,000 shares, par value $0.001 | -- | -- |
| Issued and outstanding 26,078,532 and 26,035,596 shares as of June 30, 2014 and December 31, 2013 respectively | 26,079 | 26,036 |
| Warrants | $ 1,083,193 | $ 1,083,193 |
| Additional paid-in capital | 157,017,839 | 155,953,894 |
| Accumulated other comprehensive loss | (1,133,266) | (1,133,266) |
| Accumulated deficit | (141,534,065) | (132,465,370) |
| Total stockholders' equity | 15,459,780 | 23,464,487 |
| Total liabilities and stockholders' equity | $ 28,467,356 | $ 27,472,750 |
| Celator Pharmaceuticals, and Subsidiaries | ||||
| Consolidated Statements of Loss | ||||
| (Unaudited) | ||||
|
Three months ended June 30, |
Six months ended June 30, |
|||
| 2014 | 2013 | 2014 | 2013 | |
| Expenses | ||||
| Research and development | $ 2,936,114 | $ 2,018,566 | $ 5,903,967 | $ 3,669,975 |
| Leukemia & Lymphoma Society funding | (135,746) | (135,747) | (771,493) | (289,593) |
| General and administrative | 1,729,101 | 1,138,649 | 3,617,368 | 2,487,648 |
| Loss on disposal of property and equipment | -- | 124,965 | -- | 138,692 |
| Amortization and depreciation | 48,353 | 49,464 | 96,088 | 97,052 |
| Operating loss | (4,577,822) | (3,195,897) | (8,845,930) | (6,103,774) |
| Other income (expenses) | ||||
| Foreign exchange loss | (14,605) | (1,435) | (26,313) | (4,484) |
| Interest and miscellaneous income | 1,942 | 3,037 | 4,257 | 3,466 |
| Non-cash derivative instrument charge | -- | (747,311) | -- | (7,473,108) |
| Interest expense | (200,709) | (99,371) | (200,709) | (147,025) |
| Net loss | $ (4,791,194) | $ (4,040,977) | $ (9,068,695) | $ (13,724,925) |
| Net loss per share | ||||
| Basic and diluted | $ (0.18) | $ (0.18) | $ (0.35) | $ (0.77) |
| Weighted average of common shares outstanding | ||||
| Basic and diluted | 26,078,532 | 22,089,921 | 26,058,131 | 17,904,791 |