CORRECTING and REPLACING Celator® Pharmaceuticals Announces Business Update and Fiscal First Quarter

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CORRECTING and REPLACING Celator® Pharmaceuticals Announces Business Update and Fiscal First Quarter 2013 Operational and Financial Results

  • Raised $32.5 Million, Completing a $39.3 Million Private Placement Financing
  • Phase 3 Study of CPX-351 in Secondary Acute Myeloid Leukemia is Enrolling as Planned

PRINCETON, N.J.--(BUSINESS WIRE)-- Under Business Highlights, 3rd bullet should read: A Phase 2 study of CPX-351 in adults with untreated high-risk Myelodysplastic Syndrome and AML (excluding Acute Promyelocytic Leukemia) at high risk of treatment-related mortality was opened at the Fred Hutchinson Cancer Research Center. (sted A Phase 2 study of CPX-351 in adults with untreated high-risk Myelodysplastic Syndrome and AML (Non-Acute Myelogenous Leukemia) at high risk of treatment-related mortality was opened at the Fred Hutchinson Cancer Research Center.)


The corrected release reads:

CELATOR® PHARMACEUTICALS ANNOUNCES BUSINESS UPDATE AND FISCAL FIRST QUARTER 2013 OPERATIONAL AND FINANCIAL RESULTS

  • Raised $32.5 Million, Completing a $39.3 Million Private Placement Financing
  • Phase 3 Study of CPX-351 in Secondary Acute Myeloid Leukemia is Enrolling as Planned

Celator Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing new and more effective therapies to treat cancer, today reported first quarter 2013 financial results.

"Celator continues to make significant progress in advancing CPX-351, our lead investigational product. In April, the Company raised $32.5 million in the final closing of a private placement. The proceeds are expected to fully fund the Phase 3 clinical study of CPX-351," said Scott Jackson, chief executive officer of Celator Pharmaceuticals. "We were pleased to achieve our first Phase 3 milestone, which was first patient enrolled by the end of 2012, and we expect to complete enrollment by year-end 2014. We appreciate the enthusiasm and support of the organizations participating in the Phase 3 study as we strive to offer patients improved treatment options."

Business Highlights:

  • Enrollment continues 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 Acute Myeloid Leukemia (AML). Clinical sites in North America continue to open for enrollment in support of the Phase 3 study. The last patient is expected to enroll in this Phase 3 study by year-end 2014.
  • Celator completed a $32.5 million final closing of a private placement of common stock and warrants to purchase common stock. Proceeds totaling $39.3 million, including $6.8 million from prior closings, were raised in this financing and will support the late-stage clinical development of CPX-351.
  • A Phase 2 study of CPX-351 in adults with untreated high-risk Myelodysplastic Syndrome and AML (excluding Acute Promyelocytic Leukemia) at high risk of treatment-related mortality was opened at the Fred Hutchinson Cancer Research Center.
  • Dr. Lisa DeLuca joined the company as vice-president, regulatory affairs. Dr. DeLuca is responsible for ongoing interactions with global regulatory bodies, including the FDA, and leading the registration strategy for CPX-351.
  • Dr. Anthony (Tony) Tolcher, joined the Company's Scientific Advisory Board. Dr. Tolcher is a founder and the Director of Clinical Research at START (South Texas Accelerated Research Therapeutics), the world's largest Phase 1 medical oncology program. Dr. Tolcher previously served as the Director of Clinical Research at the Cancer Therapy and Research Center (CTRC) in San Antonio.
  • Scott Morenstein, managing director at Valence Life Sciences, joined the Board of Directors. Mr. Morenstein joined Caxton Advantage Venture Partners, the predecessor to Valence, in 2007, and was promoted to managing director in 2012. He has over 13 years of experience in the life sciences industry.

First Quarter 2013 Financial Results:

  • Recognized $154,000 related to the amortization of $2.0 million upfront payment received from The Leukemia and Lymphoma Society® (LLS). This is part of the $5.0 million in funding support LLS has committed to the conduct of the Phase 3 study. In first quarter 2012, the company recognized $135,000 from LLS as the last payment related to funding support for a Phase 2b study.
  • Research and development expenses were $1.7 million for the first quarter of 2013, compared to $920,000 for the first quarter of 2012. The increase in research and development expenses was primarily attributable to the increase in clinical trial and regulatory activities related to the Phase 3 CPX-351 study and severance related to staff reductions.
  • General and administrative expenses were $1.3 million for the first quarter of 2013, compared to $778,000 for the first quarter of 2012. The increase was primarily attributable to severance and relocation of the finance function to the Princeton office and for increased professional services related to the Company becoming a public reporting company.
  • The net loss per share was $0.22 for the first quarter of 2013, compared to a net loss per share of $0.18 for the first quarter of 2012.
  • As of March 31, 2013, Celator had $8.1 million in cash and cash equivalents, $2.7 million in debt, and 13.7 million shares of common stock outstanding (prior to the final closing of the private placement in April 2013 that provided net proceeds totaling $29.5 million).

About Celator Pharmaceuticals, Inc.

Celator Pharmaceuticals, Inc., with locations in Princeton, N.J., and Vancouver, B.C., is a publicly held 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; a preclinical stage product, CPX-571 (a liposomal formulation of irinotecan:cisplatin); and multiple research programs, including the 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 our expectations regarding our development plans for our product candidate. Forward-looking statements in this release involve substantial risks and uncertainties that could cause our clinical development programs, future results, 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 trials, enrollment in clinical trials, availability of data from ongoing clinical trials, expectations for regulatory approvals, 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.

 
Celator Pharmaceuticals, Inc. and Subsidiaries
(A development stage company)
Consolidated Statement of Operations
(Unaudited)
  
Three months ended
March 31
 2013  2012 
Expenses
Research and development$1,651,409$920,475
Leukemia & Lymphoma Society funding(153,846)(135,000)
General and administrative1,348,999778,350
Loss on disposal of property and equipment13,72713,872
Amortization and depreciation 47,588  85,965 
Operating loss (2,907,877) (1,663,662)
Other income (expenses)
Foreign exchange (loss) gain(3,049)83
Interest and miscellaneous income429879
Interest expense (47,654) (366,917)
Loss before income taxes (2,958,151) (2,029,617)
Income tax -  - 
Net loss incurred in the developmental stage$(2,958,151)$(2,029,617)
 
Net loss per share
Basic and diluted$(0.22)$(0.18)
 
Weighted average of common shares outstanding
Basic and diluted 13,673,160  11,230,667 
 
Celator Pharmaceuticals, Inc. and Subsidiaries
(A development stage company)
Consolidated Balance Sheets
(Unaudited)
  
March 31, 2013December 31, 2012
Assets
Current Assets
Cash and cash equivalents$8,110,389$9,648,008
Restricted cash339,37740,205
Other receivables115,5522,000,357
Prepaid expenses and deposits99,979148,275
Assets held for sale207,566251,269
Other current assets 440,000  - 
Total current assets9,312,86312,088,114
Property and equipment, net1,197,4371,245,025
Other assets 161,102  105,805 
Total assets$10,671,402 $13,438,944 
 
 
Liabilities
Current liabilities:
Accounts payable$597,169$699,858
Accrued liabilities1,937,8661,194,998
Current portion of deferred revenue615,384615,384
Current portion of loans 1,200,000  1,200,000 
Total current liabilities4,350,4193,710,240
 
Deferred revenue923,0781,076,924
Loans payable 1,500,000  1,800,000 
Total liabilities 6,773,497  6,587,164 
 
 
 
Stockholders' Equity
Common stock

Authorized 255,000,000 shares, par value $0.001 Issued and outstanding 13,673,160 shares as of March 31, 2013 and December 31, 2012

13,67313,673
Warrants1,083,1931,083,193
Additional paid-in capital118,513,671118,509,395
Accumulated and other comprehensive loss(1,133,266)(1,133,266)
Deficit accumulated during the developmental stage (114,579,366) (111,621,215)
Total Stockholders' Equity 3,897,905  6,851,780 
Total Liabilities and Stockholders' Equity$10,671,402 $13,438,944 



Sam Brown, Inc.
Mike Beyer, 773-463-4211
beyer@sambrown.com

KEYWORDS:   United States  North America  New Jersey

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