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Celator(R) Pharmaceuticals Announces Business Update and Third Quarter 2013 Financial Results

Celator Pharmaceuticals. Inc. Logo

EWING, N.J., Nov. 12, 2013 (GLOBE NEWSWIRE) -- Celator Pharmaceuticals, Inc. (Nasdaq:CPXX), a pharmaceutical company developing new and more effective therapies to treat cancer, today reported third quarter 2013 financial results.

"We are pleased with the progress the company has made this quarter," said Scott Jackson, chief executive officer of Celator. "Our stock began trading on the OTC Bulletin Board in September and this was followed by our announcement that, as of yesterday, trading started on NASDAQ. We continue to make progress with our lead product, CPX-351. We are enrolling patients in our pivotal Phase 3 study of CPX-351 in patients with secondary Acute Myeloid Leukemia (AML), which remains on track to complete enrollment by the end of 2014. In addition, we seek to demonstrate the benefit of CPX-351 in other patient populations through the enrollment of two investigator-initiated studies that commenced this quarter."

Third Quarter and Recent Business Highlights:

  • Celator common stock was approved for listing on the NASDAQ Capital Market and commenced trading on November 11, 2013. This follows Celator common stock being approved for quotation and trading on September 12, 2013 on the OTC Bulletin Board (OTCBB) and the OTC Market Group's OTC Link quotation system.
  • 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 secondary AML continued to meet expectations. Patient enrollment is on track to be completed by year-end 2014.
  • In September, enrollment started in an investigator-initiated study evaluating CPX-351 in pediatric, adolescent and young adult patients with relapsed or refractory hematologic malignancies. The study will assess the pharmacokinetics and tolerability, as well as early evidence of efficacy of CPX-351 in hematologic malignancies, including AML, acute lymphoblastic leukemia (ALL) and aggressive lymphoma.
  • In August, enrollment started in an investigator-initiated study evaluating CPX-351 in patients with untreated high-risk myelodysplastic syndrome (MDS) or AML, excluding acute promyelocytic leukemia, at high risk of treatment-related mortality.
  • In August, the United States Patent and Trademark Office (USPTO) issued a patent that covers Celator's proprietary low-cholesterol liposome compositions utilized in the company's two clinical stage products, CPX-351 and CPX-1. With the Patent Term Adjustment, this patent will expire in June 2026.
  • In July, Michael R. Dougherty, former President and CEO of Adolor Corporation, was appointed to the Celator Board of Directors.
  • Earlier today, we announced that Les Mintzmyer joined Celator as vice-president, manufacturing and technical operations.

Financial Highlights:

  • Cash Position: Cash and cash equivalents as of September 30, 2013 were $27.6 million, compared to $9.6 million as of December 31, 2012.
  • R&D Expenses: Research and development expenses were $2.3 million in the third quarter of 2013 and $6.0 million in the nine months ended September 30, 2013, compared to $1.5 million and $3.3 million in the comparable periods in 2012. The increase in R&D expense was largely due to an increase in clinical trial and regulatory activities during the quarter related to the Phase 3 study of CPX-351.
  • G&A Expenses: General and administrative expenses were $1.4 million in the third quarter of 2013 and $3.9 million in the nine months ended September 30, 2013, compared to $0.9 million and $2.8 million in the comparable 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 $3.7 million for the third quarter of 2013 and $17.4 million for the nine months ended September 30, 2013, compared to net loss of $6.2 million and $10.4 million for the comparable periods in 2012.

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:floxuridine), and 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 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 sufficiency of our working capital. 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, working capital requirements and other matters that could affect the availability or commercial potential of our drug candidates. 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, 2012 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)
September 30, 2013 December 31, 2012
Assets
Current assets:
Cash and cash equivalents $ 27,641,470 $ 9,648,008
Restricted cash 288,861 40,205
Other receivables 9,425 2,000,357
Prepaid expenses and deposits 282,452 148,275
Assets held for sale 74,086 251,269
Other current assets 530,391 --
Total current assets 28,826,685 12,088,114
Property and equipment, net 1,177,516 1,245,025
Other assets 30,838 105,805
Total assets $ 30,035,039 $ 13,438,944
Liabilities
Current liabilities:
Accounts payable $ 677,193 $ 699,858
Accrued liabilities 1,402,735 1,194,998
Current portion of deferred revenue 542,986 615,384
Current portion of loans -- 1,200,000
Total current liabilities 2,622,914 3,710,240
Deferred revenue 723,982 1,076,924
Deferred rent 23,148 --
Loans payable -- 1,800,000
Total liabilities 3,370,044 6,587,164
Stockholders' equity
Common stock
Authorized 255,000,000 shares, par value $0.001
Issued and outstanding 26,026,793 shares as of September 30, 2013 and 13,673,160 shares as of December 31, 2012 26,027 13,673
Warrants 1,083,193 1,083,193
Additional paid-in capital 155,712,593 118,509,395
Accumulated other comprehensive loss (1,133,266) (1,133,266)
Deficit accumulated during the development stage (129,023,552) (111,621,215)
Total stockholders' equity 26,664,995 6,851,780
Total liabilities and stockholders' equity $ 30,035,039 $ 13,438,944
Celator Pharmaceuticals, Inc. and Subsidiaries
(A development stage company)
Consolidated Statement of Loss and Comprehensive Loss
(Unaudited)
Three months ended Nine months ended
September 30 September 30
2013 2012 2013 2012
Expenses
Research and development $ 2,325,891 $ 1,512,855 $ 5,995,866 $ 3,295,702
Leukemia & Lymphoma Society funding (135,746) (153,846) (425,339) (288,846)
Research collaboration income -- -- -- (19,440)
General and administrative 1,434,436 945,926 3,922,084 2,845,095
(Gain) loss on disposal of property and equipment (12,059) 30,853 126,633 50,352
Amortization and depreciation 51,239 80,977 148,291 252,656
Operating loss (3,663,761) (2,416,765) (9,767,535) (6,135,519)
Other income (expenses)
Foreign exchange (loss) gain (16,745) -- (21,229) (12,413)
Interest and miscellaneous income 3,094 (4,763) 6,560 2,127
Gain on settlement in exchange of preferred stock -- 268 -- --
Non-cash derivative instrument charge -- -- (7,473,108) --
Interest expense -- (3,793,634) (147,025) (4,220,970)
Net loss attributable to common stockholders (3,677,412) (6,214,894) (17,402,337) (10,366,775)
Net loss per share
Basic and diluted $ (0.14) $ (0.47) $ (0.87) $ (0.87)
Weighted average of common shares outstanding
Basic and diluted 26,026,793 13,319,077 19,977,071 11,931,885

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Source:Celator Pharmaceuticals. Inc.