Celator® Pharmaceuticals Announces Third Quarter 2015 Financial Results and Business Update

News provided by

Nov 12, 2015, 04:05 ET

EWING, N.J., Nov. 12, 2015 /PRNewswire/ -- Celator Pharmaceuticals, Inc. (Nasdaq: CPXX) today reported business highlights and financial results for the third quarter ended September 30, 2015.

"The momentum builds as we continue to deliver on our milestones, from the induction response rate improvement observed in our Phase 3 study with VYXEOS™ (formerly CPX-351) and announced last quarter, to impressive results from data packages on novel combination programs," said Scott Jackson, Chief Executive Officer of the Company. "The external validation of our proprietary technologies, as evidenced with VYXEOS being selected as the Nanomedicine Product of the Year is very exciting. We expect the overall survival data from the Phase 3 study in the first quarter of 2016."

Third Quarter 2015 and Recent Highlights:

Celator will receive more than $1.675 million from the sale of its net operating losses and research and development credits under the New Jersey Technology Business Tax Certificate Transfer Program. The Company expects to receive this amount by the end of 2015.
Pre-clinical data presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics demonstrated the broad applicability of Celator's hydrophobic prodrug nanoparticle (HPN) delivery technology to molecularly targeted agents, including inhibitors of MEK, Akt, HSP90 and B-Raf. Significant efficacy improvements for HPN co-formulated combinations over conventional administration of targeted agent regimens were reported.
VYXEOS (formerly CPX-351) was selected the Best Nanomedicine Product of the Year by a panel of pharmaceutical industry specialists that recognizes innovative product developments in nanomedicine.
Celator announced top-line results from an intensive QT/QTc study showing VYXEOS has no QT/QTc interval prolongation and that additional data will be presented at the upcoming American Society of Hematology (ASH) Annual Meeting. This study was conducted to support the New Drug Application for VYXEOS which the Company plans to file in the third quarter of 2016.
The Independent Data and Safety Monitoring Board (DSMB) for the Company's Phase 3 clinical study with VYXEOS has completed the final pre-planned safety review of all patients and has again recommended the study continue as planned without any modifications.
Patients began enrolling in an investigator-initiated Phase 2 clinical study evaluating VYXEOS as a treatment for patients with newly diagnosed acute myeloid leukemia (AML) at high risk for induction treatment mortality.
Celator's senior management team hosted an Analyst and Investor Day to discuss the company's growth strategy, its lead product candidate, VYXEOS, and its proprietary CombiPlex® technology platform.
Michael R. Dougherty was appointed Executive Chairman of the Board of Directors. Mr. Dougherty has been a director of Celator since July 2013 and served as Chairman since September 2014.

Financial Highlights:

Cash Position: Cash and cash equivalents as of September 30, 2015 were $24.1 million, compared to $32.4 million as of December 31, 2014. The decrease was primarily due to $13.3 million of net cash used in operating activities, partially offset by $5.0 million in proceeds from the final draw down of the Hercules Technology Growth Capital loan. Cash and cash equivalents as of June 30, 2015 were $28.5 million. Management believes that the cash and cash equivalents at September 30, 2015 will be sufficient to meet estimated working capital requirements and fund planned operations into the second half of 2016.
R&D Expenses: Research and development expenses were $2.9 million and $9.0 million for the three and nine months ended September 30, 2015, as compared to $3.3 million and $9.2 million for the same periods in 2014. The decrease in R&D expenses in the comparable three-month and nine-month periods were primarily due to decreases in regulatory and clinical trial costs related to the Phase 3 study of VYXEOS and manufacturing and drug costs.
G&A Expenses: General and administrative expenses were $1.9 million and $5.7 million for the three and nine months ended September 30, 2015, as compared to $1.9 million and $5.5 million for the same periods of 2014. The increase in the comparable nine-month period was primarily attributable to increases in compensation, public company expenses and professional fees offset by reductions in consulting and recruiting fees.
Net Loss: Net loss was $5.2 million and $14.9 million for the three and nine months ended September 30, 2015, as compared to $5.5 million and $14.5 million for the same periods in 2014.

Conference Call Information:

Celator will host a conference call and live audio webcast today at 4:30 p.m. ET to provide a business update and discuss the third quarter 2015 financial results. To participate in the conference call, please dial (877) 303-6316 (domestic) or (650) 521-5176 (international) and refer to conference ID 75399779. The live webcast of the call can be accessed in the Investors section of Celator's website at www.celatorpharma.com. An archived webcast will be available on Celator'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 clinical stage biopharmaceutical company that is transforming the science of combination therapy, and developing products to improve patient outcomes in cancer. Celator's proprietary technology platform, CombiPlex®, enables the rational design and rapid evaluation of optimized combinations incorporating traditional chemotherapies as well as molecularly targeted agents to deliver enhanced anti-cancer activity. CombiPlex addresses several fundamental shortcomings of conventional combination regimens, as well as the challenges inherent in combination drug development, by identifying the most effective synergistic molar ratio of the drugs being combined in vitro, and fixing this ratio in a nano-scale drug delivery complex to maintain the optimized combination after administration and ensure its exposure to the tumor. Celator's pipeline includes lead product, VYXEOS™ (formerly CPX-351), a liposomal formulation of cytarabine:daunorubicin being studied for the treatment of acute myeloid leukemia; CPX-1, a liposomal formulation of irinotecan:floxuridine being studied for the treatment of colorectal cancer; and a preclinical stage product candidate, CPX-8, a hydrophobic docetaxel prodrug nanoparticle formulation, being studied by the National Cancer Institute's Nanotechnology Characterization Laboratory. The company is advancing the CombiPlex platform and broadening its application to include molecularly targeted therapies. The company is seeking research and development collaborations, applying its proprietary technologies, with other biotechnology/pharmaceutical companies.

For more information, please visit Celator'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 the safety, potential efficacy and therapeutic potential of VYXEOS (formerly CPX-351), the availability and timing of release of data from clinical studies, our expectations regarding our research and development programs, 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 research and 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 clinical studies, enrollment in clinical studies, availability of data from ongoing clinical studies, whether clinical study results for VYXEOS obtained to date will be predictive of future results, regulatory risks and uncertainties 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 Celator in general, see Celator's Form 10-K for the year ended December 31, 2014, subsequent reports on Form 10-Q and 8-K, and other filings by Celator with the U.S. Securities and Exchange Commission.

Celator Pharmaceuticals, Inc. and Subsidiaries
Consolidated Balance Sheets
(Unaudited)


		September 30, 2015	December 31, 2014
	Assets
	Current assets:
	Cash and cash equivalents	$ 24,104,631	$ 32,413,777
	Restricted cash	190,082	194,561
	Other receivables	78,252	21,102
	Prepaid expenses and deposits	513,995	482,472
	Other current assets	419,376	458,278
	Total current assets	25,306,336	33,570,190
	Property and equipment, net	900,836	1,004,412
	Other assets	543,250	544,501
	Total assets	$ 26,750,422	$ 35,119,103

	Liabilities
	Current liabilities:
	Current portion of debt	$ 4,416,459	$ 284,961
	Accounts payable	304,463	723,765
	Accrued liabilities	2,313,482	1,735,420
	Current portion of deferred revenue	180,995	542,986
	Total current liabilities	7,215,399	3,287,132

	Deferred revenue	-	45,249
	Deferred rent	38,155	45,408
	Loan payable	10,840,263	9,836,256
	Total liabilities	18,093,817	13,214,045

	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 33,799,539 and 33,681,355 shares as of September 30, 2015 and December 31, 2014, respectively	33,800	33,681
	Warrants	1,083,193	1,083,193
	Additional paid-in capital	172,943,931	171,289,703
	Accumulated other comprehensive loss	(1,133,266)	(1,133,266)
	Accumulated deficit	(164,271,053)	(149,368,253)
	Total stockholders' equity	8,656,605	21,905,058
	Total liabilities and stockholders' equity	$ 26,750,422	$ 35,119,103

Celator Pharmaceuticals, Inc. and Subsidiaries
Consolidated Statements of Loss
(Unaudited)


		Three months ended		Nine months ended
		September 30,		September 30,
		2015	2014	2015	2014
	Expenses
	Research and development	$ 2,859,852	$ 3,334,789	$ 9,020,994	$ 9,238,756
	Leukemia & Lymphoma Society funding	(135,747)	(135,747)	(1,307,240)	(907,240)
	General and administrative	1,943,003	1,874,412	5,718,986	5,491,779
	Amortization and depreciation	49,740	48,521	148,062	144,609
	Operating loss	(4,716,848)	(5,121,975)	(13,580,802)	(13,967,904)
	Other income (expenses)
	Foreign exchange loss	(8,631)	(1,408)	(20,894)	(27,721)
	Interest and miscellaneous income	248	2,887	6,500	7,144
	Interest expense	(485,060)	(359,321)	(1,307,604)	(560,031)
	Net loss	$ (5,210,291)	$ (5,479,817)	$ (14,902,800)	$ (14,548,512)

	Net loss per share
	Basic and diluted	$ (0.15)	$ (0.21)	$ (0.44)	$ (0.56)

	Weighted average of common shares outstanding
	Basic and diluted	33,799,539	26,078,532	33,759,351	26,065,006