UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 10-Q 

 

 

(Mark One)

x	QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the Quarterly Period Ended June 30, 2015

 

or

 

¨	TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from                      to                     

 

Commission file number 000-54852 

 

 

CELATOR PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter) 

 

 

Delaware		20-2680869
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)
200 PrincetonSouth Corporate Center Suite 180 Ewing, New Jersey		08628
(Address of principal executive offices)		(Zip Code)

 

(609)-243-0123

(Registrant’s telephone number, including area code)

 

(Former name or former address, if changed since last report)

  

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes   x     No   ¨

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes   x     No   ¨

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer	¨		Accelerated filer	¨
Non-accelerated filer	¨    (Do not check if a smaller reporting company)		Smaller Reporting Company	x

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).   Yes   ¨     No   x

 

The number of shares outstanding of the registrant’s common stock, $0.001 par value, as of August 10, 2015 was 33,799,539.

 

 

CELATOR PHARMACEUTICALS, INC.

TABLE OF CONTENTS

			Page
Part I.		FINANCIAL INFORMATION
Item 1.		Financial Statements (Unaudited)	1
		Consolidated Balance Sheets as June 30, 2015 and December 31, 2014	1
		Consolidated Statements of Loss for the three and six months ended June 30, 2015 and June 30, 2014	2
		Consolidated Statements of Stockholders’ Equity for the six months ended June 30, 2015	3
		Consolidated Statements of Cash Flows for the six months ended June 30, 2015 and June 30, 2014	4
		Notes to Consolidated Financial Statements	5
Item 2.		Management’s Discussion and Analysis of Financial Condition and Results of Operations	12
Item 3.		Quantitative and Qualitative Disclosures About Market Risk	16
Item 4.		Controls and Procedures	16
Part II.		OTHER INFORMATION
Item 1.		Legal Proceedings	17
Item 1A.		Risk Factors	17
Item 2.		Unregistered Sales of Equity Securities and Use of Proceeds	17
Item 6.		Exhibits	17
Signature			18
Certifications			19

 

Part I. Financial Information

 

Item 1. Financial Statements

Celator Pharmaceuticals, Inc. and Subsidiaries

 

Consolidated Balance Sheets

(Unaudited)

 

		June 30, 2015				December 31, 2014
Assets
Current assets:
Cash and cash equivalents		$	28,481,204			$	32,413,777
Restricted cash			192,126				194,561
Other receivables			925,869				21,102
Prepaid expenses and deposits			589,345				482,472
Other current assets			433,270				458,278
Total current assets			30,621,814				33,570,190
Property and equipment, net			940,218				1,004,412
Other assets			554,888				544,501
Total assets		$	32,116,920			$	35,119,103
Liabilities
Current liabilities:
Current portion of debt		$	3,054,749			$	284,961
Accounts payable			1,079,592				723,765
Accrued liabilities			2,086,308				1,735,420
Current portion of deferred revenue			316,742				542,986
Total current liabilities			6,537,391				3,287,132
Deferred revenue			-				45,249
Deferred rent			40,971				45,408
Loan payable			12,156,380				9,836,256
Total liabilities			18,734,742				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 June 30, 2015 and December 31, 2014, respectively			33,800				33,681
Warrants			1,083,193				1,083,193
Additional paid-in capital			172,459,213				171,289,703
Accumulated other comprehensive loss			(1,133,266	)			(1,133,266	)
Accumulated deficit			(159,060,762	)			(149,368,253	)
Total stockholders' equity			13,382,178				21,905,058
Total liabilities and stockholders' equity		$	32,116,920			$	35,119,103

 

 

See accompanying notes to consolidated financial statements.

 

 

Celator Pharmaceuticals, Inc. and Subsidiaries

 

Consolidated Statements of Loss

(Unaudited)

  

		Three months ended								Six months ended
		June 30								June 30
		2015				2014				2015				2014
Expenses
Research and development		$3,453,131				$2,936,114				$6,161,142				$5,903,967
Leukemia & Lymphoma Society funding			(1,035,746	)			(135,746	)			(1,171,493	)			(771,493	)
General and administrative			2,014,534				1,729,101				3,775,983				3,617,368
Amortization and depreciation			49,394				48,353				98,322				96,088
Operating loss			(4,481,313	)			(4,577,822	)			(8,863,954	)			(8,845,930	)
Other income (expenses)
Foreign exchange loss			(21,902	)			(14,605	)			(12,263	)			(26,313	)
Interest and miscellaneous income			3,111				1,942				6,252				4,257
Interest expense			(481,422	)			(200,709	)			(822,544	)			(200,709	)
Net loss		$	(4,981,526	)		$	(4,791,194	)		$	(9,692,509	)		$	(9,068,695	)
Net loss per share
Basic and diluted		$	(0.15	)		$	(0.18	)		$	(0.29	)		$	(0.35	)
Weighted average of common shares outstanding
Basic and diluted			33,772,583				26,078,532				33,738,923				26,058,131

 

 

See accompanying notes to consolidated financial statements.

 

Celator Pharmaceuticals, Inc. and Subsidiaries

 

Consolidated Statement of Stockholders’ Equity

For the Six Months Ended June 30, 2015

(Unaudited)

 

		Common Stock												Additional Paid-				Accumulated Other								Stockholders’
		Number				Amount				Warrants				In Capital				Comprehensive Loss				Accumulated Deficit				Equity
Balance at December 31, 2014			33,681,355			$	33,681			$	1,083,193			$	171,289,703			$	(1,133,266	)		$	(149,368,253	)		$	21,905,058
Issued for cash on exercise of stock options			57,667				58				-				129,693				-				-				129,751
Stock-based compensation			-				-				-				794,138				-				-				794,138
Warrants issued			-				-				-				76,897				-				-				76,897
Stock issued for payment of accrued bonuses			60,517				61				-				168,782				-				-				168,843
Net loss for the period			-				-				-				-				-				(9,692,509	)			(9,692,509	)
Balance at June 30, 2015			33,799,539			$	33,800			$	1,083,193			$	172,459,213			$	(1,133,266	)		$	(159,060,762	)		$	13,382,178

 

 

 

See accompanying notes to consolidated financial statements.

 

 

Celator Pharmaceuticals, Inc. and Subsidiaries

 

Consolidated Statements of Cash Flows

(Unaudited)

 

 

		Six months ended
		June 30,
		2015				2014
Operating activities
Net loss		$	(9,692,509	)		$	(9,068,695	)
Adjustments to reconcile net loss to net cash used in operating activities
Amortization and depreciation			98,322				96,088
Non-cash stock-based compensation expense			794,138				642,597
Non-cash financing costs			206,398				57,167
Changes in operating assets and liabilities
Other receivables			(904,767	)			1,410,237
Prepaid expenses and deposits			(107,086	)			(107,135	)
Restricted cash			(19	)			(25	)
Other current assets			25,008				(410,667	)
Accounts payable			362,407				(666,455	)
Accrued liabilities			482,493				(83,059	)
Deferred rent			(4,437	)			(3,240	)
Deferred revenue			(271,493	)			(271,493	)
Cash used in operating activities			(9,011,545	)			(8,404,680	)
Investing activities
Purchase of property and equipment			(34,128	)			(3,995	)
Cash used in investing activities			(34,128	)			(3,995	)
Financing activities
Proceeds from issuance of common stock and on options exercised			129,751				104,387
Proceeds from loans payable			5,000,000				9,827,216
Payment of debt issuance costs			-				(184,469	)
Repayments of loans payable			-				-
Cash provided by financing activities			5,129,751				9,747,134
Effect of foreign exchange rate changes			(16,651	)			(3,457	)
Net change in cash			(3,932,573	)			1,335,002
Cash and cash equivalents, beginning of period			32,413,777				23,589,516
Cash and cash equivalents, end of period		$	28,481,204			$	24,924,518
Supplemental disclosure of cash flow information
Interest paid			578,229				62,292
Debt issuance costs incurred but not paid			50,000				-
Warrants issued in connection with debt issuance costs			76,897				-
Common stock issued in payment of accrued bonuses			168,843				-

 

 

See accompanying notes to consolidated financial statements

 

 

Celator Pharmaceuticals, Inc. and Subsidiaries

 

Notes to the Consolidated Financial Statements

(Unaudited)

 

1.

Nature of Business and Liquidity

 

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. The Company’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 until exposure to the tumor following administration. The Company’s pipeline includes lead product, CPX-351 (a liposomal formulation of cytarabine:daunorubicin) for the treatment of acute myeloid leukemia, which the Company has named “VYXEOS^TM”; 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 several programs exploring novel combinations of existing drugs, including molecularly targeted therapies.

 

The Company has incurred recurring losses and negative cash flows from operations since inception. As of June 30, 2015, the Company had an accumulated deficit of $159.1 million. The Company expects operating losses and negative cash flows to continue for the foreseeable future until such time, if ever, that it can generate significant revenues from its product candidates currently in development. At June 30, 2015, the Company had cash and cash equivalents of $28.5 million. Management believes that the cash and cash equivalents at June 30, 2015 will be sufficient to meet estimated working capital requirements and fund planned operations into the second half of 2016.

 

The Company is subject to those risks associated with any specialty pharmaceutical company that has substantial expenditures for research and development. There can be no assurance that the Company’s research and development projects will be successful, that products developed will obtain necessary regulatory approval, or that any approved product will be commercially viable. Substantial additional financing will be needed by the Company to fund its operations and to commercialize its product candidates. In addition, the Company operates in an environment of rapid technological change and is largely dependent on the services of its employees and consultants.

 

2.

Summary of Significant Accounting Policies

 

The accompanying unaudited consolidated financial statements and related disclosures have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) and should be read in conjunction with the consolidated financial statements and notes included in Company’s Annual Report on Form 10-K for the year ended December 31, 2014. Certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) have been omitted.

 

In the opinion of management of the Company, the interim consolidated financial statements reflect all adjustments considered necessary for a fair presentation of the financial position, operating results and cash flows of the interim periods. All such adjustments are of a normal, recurring nature. The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the full year.

 

Basis of consolidation: The consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries, Celator Pharmaceuticals Corp. (“CPC”) and Celator UK Ltd. All intercompany transactions have been eliminated.

 

Use of estimates: The preparation of the consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. Actual results may differ from those estimates. Significant areas requiring management estimates in the preparation of these consolidated financial statements include, amongst other things, assessment of other receivables, accrued liabilities, impairment and amortization of property and equipment, valuation allowance for deferred income taxes, valuation of stock-based compensation and contingencies.

 

New Accounting Pronouncements: In April 2015, the Financial Accounting Standards Board (“FASB”) issued guidance, which requires that debt issuance costs be presented in the balance sheet as a deduction from the carrying amount of the related liability, rather than as a deferred charge. The updated guidance is effective retroactively for financial statements covering fiscal years beginning after December 15, 2015, and interim periods within those fiscal years. Early adoption is permitted but we do not anticipate electing early adoption. We are currently evaluating the impact of the adoption of this guidance on our consolidated financial statements.

 

  

Celator Pharmaceuticals, Inc. and Subsidiaries

 

Notes to the Consolidated Financial Statements

(Unaudited)

 

In August 2014, the FASB issued guidance on management’s responsibility in evaluating whether there is substantial doubt about a company’s ability to continue as a going concern and about related footnote disclosures. For each reporting period, management will be required to evaluate whether there are conditions or events that raise substantial doubt about a company’s ability to continue as a going concern within one year from the date the financial statements are issued. The guidance is effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter.

 

3.

Fair Value Measurements

 

Financial instruments of the Company consist of cash deposits, money market investments, other receivables, accounts payable, certain accrued liabilities and debt. The carrying value of these financial instruments generally approximates fair value due to their short-term nature. The Company believes that the current carrying amount of its long-term debt approximates fair value because interest rate on this instrument is similar to rates that the Company would be able to receive for similar instruments of comparable maturity.

 

FASB Accounting Standards Codification (“ASC”) Topic 820, Fair Value Measurements establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. A financial instrument’s categorization within the fair value hierarchy is based upon the lowest level of input that is significant to the fair value measurement. ASC 820-10 establishes three levels of inputs that may be used to measure fair value:

 

Level 1 applies to assets or liabilities for which there are quoted prices in active markets for identical assets or liabilities.

 

Level 2 applies to assets or liabilities for which there are inputs, other than quoted prices included within Level 1, that are observable for the asset or liability, such as: quoted prices for similar assets or liabilities in active markets; quoted prices for identical assets or liabilities in markets with insufficient volume or infrequent transactions (less active markets); or model-derived valuations in which significant inputs are observable or can be derived principally from, or corroborated by, observable market data.

 

Level 3 applies to assets or liabilities for which there are unobservable inputs to the valuation methodology that are significant to the measurement of the fair value of the assets or liabilities.

 

ASC 820 requires disclosures about transfers into and out of Levels 1 and 2 and separate disclosures about purchases, sales, issuances, and settlements relating to Level 3 measurements. It also clarifies existing fair value disclosures regarding the level of disaggregation and the inputs and valuation techniques used to measure fair value.

 

The Company recognizes transfers between input levels as of the actual date of event. There were no transfers between levels and the following table provides the assets carried at fair value:

 

		Fair Value				(Level 1)				(Level 2)				(Level 3)
June 30, 2015
Assets:
Money Market Fund		$	26,128,494			$	26,128,494			$	-			$	-
December 31, 2014
Assets:
Money Market Fund		$	29,500,819			$	29,500,819			$	-			$	-

  

4.

Other Receivables

 

Other receivables as of June 30, 2015 and December 31, 2014, consist of the following:

 

		June 30, 2015				December 31, 2014
Receivables related to the Leukemia & Lymphoma Society funding		$	900,000			$	-
Other receivables			25,869				21,102
		$	925,869			$	21,102

 

 

Celator Pharmaceuticals, Inc. and Subsidiaries

 

Notes to the Consolidated Financial Statements

(Unaudited)

 

5.

Other Current Assets

 

Other current assets as of June 30, 2015 and December 31, 2014 consist of the following:

 

		June 30, 2015				December 31, 2014
Clinical trial materials		$	433,270			$	458,278

  

6.

Property and Equipment

 

Property and equipment as of June 30, 2015 and December 31, 2014 including assets held under capital lease, consists of the following:

  

		June 30, 2015				December 31, 2014
Computer and equipment		$	146,704			$	144,138
Furniture and office equipment			96,457				96,457
Laboratory equipment			1,741,955				1,723,331
Capital lease equipment			155,524				155,524
Leaseholds			50,727				37,789
			2,191,367				2,157,239
Less: Accumulated depreciation			(1,251,149	)			(1,152,827	)
		$	940,218			$	1,004,412

 

		Three months ended								Six months ended
		June 30								June 30
		2015				2014				2015				2014
Depreciation and amortization		$	49,394			$	48,353			$	98,322			$	96,088

  

7.

Other Assets

 

Other assets as of June 30, 2015 and December 31, 2014 consist of the following:

 

		June 30, 2015				December 31, 2014
Deferred financing costs		$	549,707			$	539,296
Other assets non current assets			5,181				5,205
		$	554,888			$	544,501

  

8.

Accrued Liabilities

 

Accrued liabilities as of June 30, 2015 and December 31, 2014 consist of the following:

 

		June 30, 2015				December 31, 2014
Accrued clinical trial expenses		$	715,604			$	633,395
Accrued bonuses			472,298				816,144
Accrued salaries and vacation			212,351				152,700
Accrued drug manufacturing expenses			210,677				-
Interest payable			121,875				83,958
Accrued trade payables other			353,503				49,223
		$	2,086,308			$	1,735,420

 

 

Celator Pharmaceuticals, Inc. and Subsidiaries

 

Notes to the Consolidated Financial Statements

(Unaudited)

 

9.

Loans Payable

 

On May 9, 2014, the Company entered into a term loan agreement for $15 million with Hercules Technology Capital Growth (“Hercules”). The first $10 million of the term loan was funded at closing. On March 30, 2015, the Company drew down the remaining $5 million of the term loan. The term loan is repayable in installments over forty-eight months including an interest-only period of eighteen months after closing. Interest is payable monthly at the greater of 9.75% or an adjusted rate based upon the US prime rate with interest only period until December 1, 2015. The funds will be used to provide general working capital.

 

Pursuant to the loan agreement, the Company issued Hercules a warrant to purchase an aggregate of 210,675 shares of the Company’s common stock at an exercise price of $2.67 per share with a term of five years. The warrant is exercisable beginning on the date of issuance and expires May 9, 2019. The fair value of the warrants of $397,649 and financing costs of $407,253 incurred in connection with the term loan were recorded as debt issuance costs and will be amortized as interest expense using the effective interest method over the term of the loan. Amortization of debt issuance costs was $65,968 and $30,507 for the three months ended June 30, 2015 and 2014, respectively. For the six months ended June 30, 2015 and 2014, the amortization of debt issuance costs was $116,486 and $30,507, respectively. The remaining unamortized debt issuance costs of $549,707 are included in other non-current assets.

 

In addition, the Company will pay an end of term charge of $592,500 on the earliest to occur of (i) the term loan maturity date, (ii) the date that the Company prepays the outstanding loan, or (iii) the date that the loan becomes due and payable. The end of term charge will be accrued as additional interest expense using the effective interest rate method over the term of the loan. The Company accrued $45,766 and $26,660 of this fee during the three months ended June 30, 2015 and 2014, respectively. For the six months ended June 30, 2015 and 2014, the Company accrued $89,912 and $26,660, respectively.

 

Long-term debt as of March 31, 2015 and December 31, 2014, consists of the following:

 

		June 30, 2015				December 31, 2014
Loan payable		$	15,000,000			$	10,000,000
End of term fee			211,129				121,217
			15,211,129				10,121,217
Less: Current portion			(3,054,749	)			(284,961	)
Long-term debt		$	12,156,380			$	9,836,256

  

10.

Stock Based Compensation

 

2013 Equity Incentive Plan

 

In 2013, the Company adopted the Celator Pharmaceuticals, Inc. 2013 Equity Incentive Plan (the “Plan”). Options granted under the Plan may be incentive stock options or non-qualified stock options. Incentive stock options may only be granted to employees. The board of directors, or a committee of the board of directors appointed to administer the Plan, determines the period over which options become exercisable and the conditions under which stock awards are granted and become vested.

 

 

Celator Pharmaceuticals, Inc. and Subsidiaries

 

Notes to the Consolidated Financial Statements

(Unaudited)

 

 The following table summarizes the activity of the Company’s stock option plan for the six months ended June 30, 2015:

 

		Number of options				Exercise price				Weighted-Average Remaining Contractual Term (Years)				Aggregate Intrinsic Value
December 31, 2014			3,005,287			$	3.02
Granted			700,500				2.76
Exercised			(57,667	)			2.25
Expired			(155,482	)			2.38
Cancelled			(50,000	)			3.17
June 30, 2015			3,442,638			$	3.00				7.7			$	13,898
Exercisable at June 30, 2015			1,510,447			$	2.97				6.3			$	13,028

  

The following table provides information regarding stock options activity during the periods: 

 

		Three months ended								Six months ended
		June 30								June 30
		2015				2014				2015				2014
Stock compensation expense recognized		$	434,938			$	339,615			$	794,138			$	642,597
Weighted average grant-date fair value of stock options issued (per share)		$	2.07			$	2.35			$	2.27			$	2.70
Grant-date fair value of stock options issued		$	229,359			$	197,400			$	1,589,435			$	1,291,950
Volatility			100.1	%			112.0	%			105.8	%			114.5	%
Risk-free interest rate			1.9	%			1.9	%			1.7	%			2.0	%
Dividend yield			0	%			0	%			0	%			0	%
Expected life in years			6.0				6.0				6.2				6.2
Intrinsic value of stock options exercised		$	-			$	-			$	-			$	38,892

 

The grant-date fair value of stock options is estimated using the Black Scholes option pricing model. The Company determined the options’ life based on the simplified method and determined the options’ expected volatility based on peer group volatility and dividend yield based on the historical dividend payments. The risk free interest rate is based on the yield of an applicable term Treasury instrument.

 

 The Company amortizes the fair value of the stock options on a straight-line basis over the applicable requisite service periods of the awards, which is generally the vesting period. At June 30, 2015, the total compensation cost related to non-vested awards not yet recognized and weighted average period over which it will be recognized was $4,314,260 and 2.6 years, respectively.

 

Stock Issuance

 

In February 2015, the Company issued 60,517 shares of common stock to certain Company employees as payment for bonus accrued or earned in 2014 fiscal year. For one year from the date of issuance, the shares issued are non-transferable and are subject to forfeiture if the holder violates any confidentiality undertaking, non-competition agreement, non-solicitation agreement or other restrictive covenant under the employee’s employment agreement with the Company.

 

11.

Geographic Segment Information

 

The Company operates in the United States and Canada. The Company’s CPX-351 clinical trial materials are manufactured by a third party using the Company’s equipment located in Germany. Geographic net loss information is based on the location whereby the expenses were incurred. The geographic information about total assets is based on the physical location of the assets.

 

 

Celator Pharmaceuticals, Inc. and Subsidiaries

 

Notes to the Consolidated Financial Statements

(Unaudited)

 

		Total Assets
		June 30, 2015				December 31, 2014
United States		$	31,121,751			$	34,027,837
Canada			202,197				223,572
Germany			792,972				867,694
Total Assets		$	32,116,920			$	35,119,103

 

		Net Loss
		Three months ended								Six months
		June 30								June 30
		2015				2014				2015				2014
United States			(4,391,695	)			(4,276,673	)			(8,703,036	)			(7,931,554	)
Canada			(589,831	)			(514,521	)			(989,473	)			(1,137,141	)
Total Net Loss		$	(4,981,526	)		$	(4,791,194	)		$	(9,692,509	)		$	(9,068,695	)

 

12.

Commitments and Contingencies

 

In September 2014, the Company entered into a lease agreement for a laboratory space in Vancouver, British Columbia, which expires in September 2015. The remaining minimum lease payments as of June 30, 2015 were $6,882.

 

In March 2013, the Company entered into an office lease agreement for office space in Ewing, New Jersey, which commenced in June 2013 with a term of sixty months. The remaining minimum lease payments as of June 30, 2015 were $427,056. Under the Ewing, New Jersey lease agreement, the Company will be obligated to maintain a letter of credit from a bank with respect to its security deposit obligations in the amount of $200,000 during the first year of the Agreement, which amount will be reduced by $40,000 per year on each of December 1, 2014, 2015, and 2016 and by $60,000 on December 1, 2017.

 

In February 2013, the Company renewed its office lease agreements for office space in Vancouver, British Columbia, effective April 1, 2013, which expires in June 2016. The remaining minimum lease payments as of June 30, 2015 were $57,768.

 

The Company has a worldwide exclusive license agreement with Princeton University dated June 2007 that provides the Company with exclusive rights to some aspects of its nanoparticle polymer technology arising from research sponsored by the Company at Princeton University between 2003 and 2007. These inventions are generally characterized as particulate constructs for release of active agents for medical application. Of the products currently in the Company’s pipeline, only the hydrophobic docetaxel prodrug nanoparticle (HDPN) formulation is subject to this agreement. The Company is obligated to pay a royalty on net sales to Princeton University of a low single-digit percentage if any invention is sold by the Company or a company to which the product covered by the invention was licensed by the Company, which was generated under the exclusive licensing agreement. No royalty or other product/sub-license-related payments have been made to date. The Company is obligated to provide Princeton University a percentage within the range of 45% to 55% of proceeds obtained from a sub-license of the intellectual property to a third party in cases where the Company has not conducted any research or development activities and is solely licensing out the original intellectual property jointly developed by the Company and Princeton University. The Company may terminate the agreement at any time by giving 90 days written notice to Princeton University. Princeton may terminate the agreement if the Company should breach or fail to perform under the agreement, with written notice of default provided by Princeton University to the Company and only if the Company fails to cure the default within 60 days. The Company is obligated under the agreement to provide an annual progress report to Princeton University on any developments of the licensed technology as well as prosecution of the patents covering the technology and the use of commercially reasonable efforts to develop licensed products.

 

The Company has a collaborative research agreement dated May 2001 with the British Columbia Cancer Agency (“BCCA”) whereby in consideration for the license and conditional assignment of all Company-sponsored intellectual property to the Company by BCCA, the Company will pay to BCCA a royalty in the low single digits on net sales of royalty-bearing products in territories so long as a valid claim exists for inventions made between June 2000 and June 2005 under the agreement. All obligations relating to the conduct of the research and assignment of intellectual property have been completed. No payments of royalties have been made to date. Either party may terminate the agreement if the other party commits a material breach or default and such breach or default is not reasonably cured within 45 days.

 

 

Celator Pharmaceuticals, Inc. and Subsidiaries

 

Notes to the Consolidated Financial Statements

(Unaudited)

 

In consideration of funding by the Leukemia & Lymphoma Society ® (“LLS”) and transfer to the Company of any rights LLS may have to any project inventions developed during the term of the agreement, the Company may be required to pay LLS a cash multiple on the LLS funding, (LLS funding is the $5 million in support of the Phase 3 study in addition to the approximately $4.1 million the Company received in support of the Phase 2 study). Subject to exclusions under the agreement, the Company is obligated to pay LLS an amount equal to 50% of the cash payments the Company receives from out-licenses and transfers of rights to the product or other liquidity event, as defined in the agreement, until LLS has received an amount equal to 1.5 times the amount of funding the Company receives from LLS. The total amount payable by the Company to LLS will not exceed 3.55 times the amount of funding received from LLS, with the specific amount depending on when the payment(s) occur relative to the timing of the research program and product commercialization. The payments may take the form of cash payments or royalties (not to exceed 5% of net sales) but will not exceed the maximum amount referred to in the preceding sentence.

 

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

 

This report and other written reports and oral statements made from time to time by the Company may contain so-called “forward-looking statements,” all of which are based on management’s current expectations and are subject to risks and uncertainties that may cause results to differ materially from those set forth in the statements. One can identify these forward-looking statements by their use of words such as “anticipates,” “expects,” “plans,” “will,” “estimates,” “forecasts,” “projects” and other words of similar meaning. One can also identify them by the fact that they do not relate strictly to historical or current facts. Examples of forward-looking statements contained in this Form 10-Q quarterly report include, among others, statements about the sufficiency of its capital to fund its activities into the second half of 2016, the expected timeline for its milestones in connection with its Phase 3 clinical study, its product pipeline, statements regarding the efficacy of the Company's CombiPlex® technology, the safety, tolerability, efficacy and therapeutic potential of CPX-351, whether clinical results for CPX-351 obtained to date will be predictive of future clinical study results, the Company's expectations regarding the Company's development plans for CPX-351 and our drug candidates, and the Company's expectations about expanding the Company's product pipeline and advancing the Company's CombiPlex platform. 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, capital market conditions, the uncertainties inherent in the conduct of future clinical studies, enrollment in clinical studies, availability of data from ongoing clinical studies, expectations for regulatory approvals, and other matters that could affect the availability or commercial potential of the Company’s drug candidates. Forward-looking statements in this Form 10-Q quarterly report involve substantial risks and uncertainties that could cause the Company's clinical development programs, future results, performance of achievements to differ significantly from those expressed or implied in the forward-looking statements. One must carefully consider any such statement and should understand that many factors could cause actual results to differ materially from the Company’s forward-looking statements. These factors include inaccurate assumptions and a broad variety of other risks and uncertainties, including some that are known and some that are not. No forward-looking statement can be guaranteed and actual future results may vary materially.

 

The Company does not assume the obligation to update any forward-looking statement. One should carefully evaluate such statements in light of factors, including risk factors, described in the Company’s filings with the SEC, especially on Forms 10-K, 10-Q and 8-K. In Item 1A. “Risk Factors” of the Company’s Annual Report on Form 10-K for the year ended December 31, 2014, the Company discusses in more detail various important risk factors that could cause actual results to differ from expected or historic results. The Company notes these factors for investors as permitted by the Private Securities Litigation Reform Act of 1995. One should understand that it is not possible to predict or identify all such factors. Consequently, the reader should not consider any such list to be a complete statement of all potential risks or uncertainties.

 

Overview

 

Celator Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company that is transforming the science of combination therapy, and developing products to improve patient outcomes in cancer. The Company’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. The Company’s pipeline includes lead product, CPX-351 (a liposomal formulation of cytarabine:daunorubicin) for the treatment of acute myeloid leukemia, which the Company has named “VYXEOS^TM”; 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. The Company is advancing the CombiPlex platform and broadening its application to include molecularly targeted therapies and epigenetic modulators. Areas of investigation include:

 

•

Combinations targeting signaling pathways associated with major cancer indications

•

Combinations of existing chemotherapeutics with molecularly targeted agents

•

Combinations of epigenetic modulators

 

The majority of our current research and development funds will be spent on our lead product candidate, CPX-351. The four major CPX-351 studies are:

 

•

Study 204 — Randomized Phase 2 Study of CPX-351 in Newly Diagnosed Acute Myeloid Leukemia (“AML”) Patients Age 60 – 75

•

Study 205 — Randomized Phase 2 Study of CPX-351 in AML in First Relapse, Patients Age 18 – 65

•

Study 206 – Phase 2 Pharmacokinetic and Pharmacodynamic Study of CPX-351, Patients Age 60 – 75

•

Study 301 — Randomized Phase 3 Study in Patients with high risk secondary AML (“sAML”), Patients Age 60 – 75

 

 

Study 204 was intended to be a direct test of whether delivery of a fixed, synergistic ratio of two drugs cytarabine and daunorubicin (i.e., CPX-351 which is a 90-minute infusion on days 1, 3 and 5) provided increased clinical efficacy over conventional administration of the same agents (i.e., which is a 7-day continuous infusion of cytarabine, combined with daunorubicin on days 1, 2 and 3, commonly referred to as the 7+3 regimen) in newly diagnosed AML patients age 60 – 75. This study is complete. In the overall population, in patients treated with CPX-351 the response rate increased by 30.3% (66.7% vs. 51.2%), the 60-day mortality was decreased by 67.8% (4.7% vs. 14.6%), median event-free survival increased by 225.0% (6.5 months vs. 2.0 months) and the median overall survival increased approximately 14.0% (14.7 months vs. 12.9 months). In sAML patients as defined in the protocol, (approximately 41% of the overall population), the response rate increased by 82.0% (57.5% vs. 31.6%), the 60-day mortality decreased approximately 80.7% (6.1% vs. 31.6%), the median event-free survival increased approximately 246.2% (4.5 months vs. 1.3 months) and the median overall survival increased by 98.4% (12.1 months vs. 6.1 months).

 

Study 205 was a randomized Phase 2 clinical study designed to be a direct test of whether CPX-351 provides increased clinical efficacy over salvage therapies in first relapse AML patients age 18 – 65. This study is complete. In the overall population, CPX-351 resulted in a 20.8% relative increase in response rate (49.4% vs. 40.9%) compared to the control arm of salvage therapies, a 6.9% decrease in the 60-day mortality (14.8% vs. 15.9%), a 34.9% increase in median overall survival (8.5 months vs. 6.3 months) and an approximately 31.1% increase in 1-year survival rate (35.8% vs. 27.3%). For patients in the unfavorable risk category (68% of the overall population), CPX-351 resulted in a 42.4% relative increase in response rate (39.3% vs. 27.6%) compared to the control arm of salvage therapies, a 33.2% decrease in 60-day mortality (16.1% vs. 24.1%), a 57.1% increase in median overall survival (6.6 months vs. 4.2 months) and a higher 1-year survival rate of 177.7% (28.6% vs. 10.3%).

 

Study 206 is a Phase 2 pharmacokinetic and pharmacodynamics (“PK/PD”) study evaluating the effects of CPX-351 on cardiac repolarization in adult patients with acute hematologic malignancies, including AML, acute lymphoblastic leukemia, and myelodysplastic syndrome (MDS). The open-label, single-arm, Phase 2 study is a thorough PK/PD assessment designed to measure the effects of CPX-351 on cardiac repolarization following the first induction cycle of CPX-351, and correlate changes in cardiac repolarization with plasma pharmacokinetic data for cytarabine and daunorubicin and their metabolites. The study began enrolling patients in August 2014 and achieved full enrollment in June 2015.

 

Study 301 is a randomized controlled Phase 3 study in patients with high risk (e.g. secondary) AML, with overall survival as the primary endpoint. This Phase 3 study has been undertaken to confirm the Study 204 clinical observations where CPX-351 provided the largest efficacy improvements in these patients and to provide the necessary data for product registration. This Phase 3 study is a multicenter, randomized, open-label study testing CPX-351 versus the current standard of care, conventional cytarabine and daunorubicin therapy (7+3) in patients with untreated high-risk (e.g. secondary) AML. The Phase 3 clinical study is being conducted in patients 60 – 75 years of age who can tolerate intensive chemotherapy. This patient population is intended to be the first indication for which the Company is seeking regulatory approval. The Company achieved the following milestones related to its Phase 3 clinical study:

 

·

Study 301 enrolled the first patient in December 2012 and closed enrollment in November 2014.

·

In October 2014, the Company achieved the target enrollment, of 300 patients, in the Phase 3 study of CPX-351.

·

The independent Data and Safety Monitoring Board review in December 2014 reviewed the first 225 patients randomized, which review recommended that the study continue as planned without any modifications. Sites in the U.S. and Canada are participating in this study.

·

In June 2015, the Company announced the final analysis of the induction response rate (CR+CRi), a secondary endpoint of the study. CPX-351 resulted in a 43.2% relative increase in response rate (47.7% vs. 33.3%) compared to the 7+3 control arm.

 

The Company expects the following milestones related to its Phase 3 clinical study:

 

·

Q1 2016 — Analysis of overall survival, the primary endpoint of the study.

·

Q3 2016 — NDA submission.

 

In June 2012, the Company entered into an agreement with LLS pursuant to which the LLS is providing $5.0 million in funding from the LLS Therapy Acceleration Program (“TAP”) program for the Phase 3 study of CPX-351. The agreement provided for LLS to make an upfront payment of $2.0 million to the Company, which was received in July 2012, and further payments totaling an additional $3.0 million on the achievement of clinical milestones; however, the amount may be refundable by the Company in the event of a material breach by the Company under the agreement. The $2.0 million upfront payment was recorded as deferred revenue and will be recognized over the estimated performance period of the research and development services to be provided under the agreement. As of June 30, 2015, $0.3 million was deferred. Since November 2012, the Company has received a total of $2.9 million for milestones achieved under this agreement. In consideration of LLS’s funding, and transfer to the Company of any rights LLS may have to any project inventions developed during the term of the agreement, if CPX-351 is successful, the Company must pay LLS a multiple on the LLS funding. (The Company has received $4.9 million of the proposed $5 million from LLS in support of the Phase 3 study in addition to the approximately $4.1 million the Company received in support of the Phase 2 study during 2010 and 2011.) Subject to exclusions under the agreement, the Company is obligated to pay LLS an amount equal to 50% of the cash payments the Company receives from outlicenses and transfers of rights to the product or other liquidity event, as defined in the agreement, until LLS has received an amount equal to 1.5 times the amount of funding the Company receives from LLS. The total amount payable by the Company to LLS will not exceed 3.55 times the amount of funding received from LLS, with the specific amount depending on when the payment(s) occur relative to the timing of the research program and product commercialization. The payments may take the form of cash payments or royalties (not to exceed 5% of net sales) but will not exceed the maximum amount referred to in the preceding sentence.

 

 

On May 9, 2014, the Company entered into a term loan agreement for $15 million with Hercules Technology Capital Growth (“Hercules”). The first $10 million of the term loan was funded at closing. On March 30, 2015, the Company drew down the remaining $5 million of the term loan. The term loan is repayable in installments over forty-eight months including an interest-only period of eighteen months after closing. Interest is payable monthly at the greater of 9.75% or an adjusted rate based upon the US prime rate with interest only period until December 1, 2015. The funds will be used to provide general working capital.

 

Results of Operations

 

Three months ended June 30, 2015 compared to the three months ended June 30, 2014

 

Expenses

 

Research and Development:   The Company charges research and development costs to operations as incurred. The Company’s research and development expenses were $3,453,000 for the three months ended June 30, 2015 compared to $2,936,000 for the three months ended June 30, 2014 reflecting an increase of $517,000. The increase was primarily attributable to $223,000 increase in costs associated with the advancement of the CombiPlex combination work initiated in 2014, $175,000 increase in regulatory and clinical trial costs related to the Phase 3 trial of CPX-351, $104,000 increase in manufacturing and drug and lipid costs, $119,000 increase in stability and validation studies, and $66,000 increase in travel costs for in-house clinical research associates and research personnel. These increases were offset by a $188,000 decrease in costs associated with a metabolism study which began during the second half of 2013 for CPX-351 and ended in July 2014.

 

LLS Funding:   The LLS revenue recognized for the three months ended June 30, 2015 was $1,036,000 and $136,000 for the three months ended June 30, 2014. The amount recognized in 2015 included a $900,000 milestone achieved related to the induction response rate analysis of the Phase 3 trial of CPX-351 completed in June 2015 and $136,000 amortization of a $2,000,000 upfront payment received during 2012 which was deferred and is being recognized over the estimated performance period of the research and development services to be provided under the agreement. The amount recognized in 2014 represents an amortization of the upfront payment received in 2012 of $136,000.

 

General and Administrative:   General and administrative expenses consist largely of salaries and related benefits, external costs for professional fees relating to legal, accounting and tax services, investor relations expenses, director and scientific advisory services as well as the lease expense for the facilities.

 

General and administrative expenses were $2,015,000 for the three months ended June 30, 2015 compared to $1,729,000 for the three months ended June 30, 2014, reflecting an increase of $286,000. The increase was primarily attributable to $271,000 increase in professional fees, and $105,000 increase in public company, investor relations and consulting costs. These increases were offset by a reduction in consulting costs associated with commercial planning of $129,000.

 

Amortization and Depreciation: Amortization and depreciation expense was $49,000 for the three months ended June 30, 2015 and $48,000 for the three months ended June 30, 2014.

 

Other Income and Expenses

 

Interest Expense: Interest expense was $481,000 and $201,000 for the three months ended June 30, 2015 and 2014, respectively, and was related to interest on a Hercules term loan entered into in May 2014. Interest expense of $481,000 for three months June 30, 2015 includes $111,000 related to non-cash amortization of deferred financing costs and the accrual of the end of term charge. Interest expense of $201,000 for the three months ended June 30, 2014 included $57,000 related to non-cash amortization of deferred financing costs and the accrual of the end of term charge.

 

Six months ended June 30, 2015 compared to the six months ended June 30, 2014

 

Expenses

 

Research and Development: The Company charges research and development costs to operations as incurred. The Company’s research and development expenses were $6,161,000 for the six months ended June 30, 2015 compared to $5,904,000 for the six months ended June 30, 2014 reflecting an increase of $257,000. The increase was primarily attributable to $311,000 increase in costs associated with the advancement of the CombiPlex combination work initiated in 2014, $369,000 increase in regulatory and clinical trial costs related to the Phase 3 trial of CPX-351, and $116,000 increase in stability and validation studies. These increases were offset by a $474,000 decrease in costs associated with a metabolism study which began during the second half of 2013 for CPX-351 and ended in July 2014, and an $84,000 decrease in costs related to manufacturing, and drug storage and shipping costs.

 

 

Leukemia & Lymphoma Society Funding: The LLS revenue recognized for the six months ended June 30, 2015 was $1,171,000 and $771,000 for the three months ended June 30, 2014. The amount recognized in 2015 included a $900,000 milestone achieved related to the induction response rate analysis of the Phase 3 trial of CPX-351 completed in June 2015 and $271,000 amortization of a $2,000,000 upfront payment received during 2012 which was deferred and is being recognized over the estimated performance period of the research and development services to be provided under the agreement. The $771,000 recognized in 2014 represents receipt of $500,000 from LLS for the fourth milestone achieved in January 2014 and amortization the upfront payment received during 2012 of $271,000.

 

General and Administrative: General and administrative expenses consist of salaries and related benefits, lease expense of the facilities, professional fees relating to legal, accounting, and tax services and other administrative costs.

 

General and administrative expenses were $3,776,000 for the six months ended June 30, 2015 compared to $3,617,000 for the six months ended June 30, 2014, reflecting an increase of $159,000. The increase was primarily attributable to $144,000 increase in public company, investor relations, and consulting costs, and $92,000 increase in professional fees. These increases were offset by a reduction in consulting associated with commercial planning of $134,000.

 

Amortization and Depreciation: Amortization and depreciation expense was $98,000 for the six months ended June 30, 2015 and $96,000 for the six months ended June 30, 2014.

 

Other Income and Expenses

 

Interest Expense: Interest expense was $822,000 and $201,000 for the six months ended June 30, 2015 and 2014, respectively, and was related to interest on a Hercules term loan entered into in May 2014. Interest expense of $822,000 for six months June 30, 2015 includes $206,000 related to non-cash amortization of deferred financing costs and the accrual of the end of term charge. Interest expense of $201,000 for the six months ended June 30, 2014 included $57,000 related to non-cash amortization of deferred financing costs and the accrual of the end of term charge.

 

Liquidity and Capital Resources

 

Overview

 

There is considerable time and cost associated with developing a potential drug or pharmaceutical product to the point of regulatory approval and commercialization. To date, the Company has funded its operations primarily through private placements of preferred stock and common stock, convertible debt and debt financings. However, the Company may pursue additional financing options, including entering into agreements with collaborative partners in order to provide milestone payments, license fees and equity investments.

 

The Company believes that, with $28.5 million in cash and cash equivalents as of June 30, 2015, it has the resources to meet estimated working capital requirements to fund operations into the second half of 2016. The Company expects to continue to incur losses as it funds research and development activities and commercial launch activities, and the Company does not expect material revenues for at least the next few years.

 

On May 9, 2014, the Company entered into a term loan agreement for $15 million with Hercules. The first $10 million of the term loan was funded at closing. On March 30, 2015, the Company drew down the remaining $5 million of the term loan. The term loan is repayable in installments over forty-eight months including an interest-only period of eighteen months after closing. Interest is payable monthly at the greater of 9.75% or an adjusted rate based upon the US prime rate with interest only period until December 1, 2015. The funds will be used to provide general working capital.

 

The Company’s future capital requirements will depend on many factors, including those factors described in Item 1A. “Risk Factors” of the 2014 Form 10-K annual report as well as the Company’s ability to execute on its business and strategic plans as currently conceived.

 

Cash Flows

 

Net cash used in operating activities was $9,012,000 for the six months ended June 30, 2015. The six months ended June 30, 2015 amount reflected the Company’s net loss of $9,693,000 offset by $1,093,000 in net non-cash charges including a non-cash charge relating to amortization and depreciation of $98,000, stock-based compensation expense of $794,000 and non-cash interest expense of $206,000 related to the deferred financing costs amortization for a term loan. In addition, the Company used $418,000 of operating cash as a result of changes in certain of its operating assets and liabilities during the six months ended June 30, 2015. The changes in operating assets and liabilities were increases in other receivables of $905,000, prepaid expenses and deposits of $107,000, and decreases in deferred revenue of $271,000 and deferred rent of $4,000; offset by increases in accounts payable of $362,000, accrued expenses of $482,000, and decrease in other current assets of $25,000.

 

 

Net cash used in operating activities was $8,405,000 for the six months ended June 30, 2014. The six months ended June 30, 2014 amount reflected the Company’s net loss of $9,069,000, offset by $796,000 in net non-cash charges including a non-cash charge relating to amortization and depreciation of $96,000, stock-based compensation expense of $643,000 and non-cash interest expense of $57,000 related to the deferred financing costs amortization for a term loan. In addition, the Company used $132,000 of operating cash as a result of changes in certain of its operating assets and liabilities during the six months ended June 30, 2014. The changes in operating assets and liabilities were decreases in other receivables of $1,410,000, offset by increases in prepaid expenses and deposits of $107,000, and other current assets of $411,000 and decreases in accounts payable of $666,000, accrued expenses of $83,000, deferred rent of $3,000 and deferred revenue of $271,000.

 

Cash used in investing activities was $34,000 and $4,000 for the six months ended June 30, 2015 and 2014, respectively, and was for property and equipment expenditures.

 

Cash provided by financing activities for the six months ended June 30, 2015 was $5,130,000. The cash inflow was from the proceeds on issuance of debt of $5,000,000 and from exercised stock options of $130,000. Cash provided by financing activities for the six months ended June 30, 2014 was $9,747,000. The cash inflow was from the net proceeds on issuance of debt of $9,643,000 and from exercised stock options of $104,000.

 

Off-Balance Sheet Arrangements

 

The Company does not have any off-balance sheet arrangements, other than operating leases, that have or are reasonably likely to have a current or future material effect on its financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources. The Company does not have any interest in special purpose entities, structured finance entities or other variable interest entities.

 

Critical Accounting Policies

 

The Company’s significant accounting policies, which include management’s best estimates and judgments, are included in Note 2 to the consolidated financial statements for the year ended December 31, 2014 included in Celator Pharmaceuticals Inc.’s Form 10-K filed. There have been no significant changes in the Company’s critical accounting policies since December 31, 2014.

 

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

 

The Company invests excess cash in investment grade, interest-bearing securities and at June 30, 2015, had approximately $26.1 million invested in money market instruments. Such investments are subject to interest rate and credit risk and are not fully insured by the federal government. The Company believes its policy of investing in highly rated securities, whose liquidities are, at June 30, 2015, all less than 90 days minimizes such risks. In addition, while a hypothetical one percent per annum decrease in market interest rates would have decreased the Company’s interest income for the period, it would not have resulted in a loss of the principal and the decline in interest income would have been immaterial to the Company.

 

The Company had outstanding total debt at June 30, 2015 of $15 million. Interest is payable monthly at the greater of 9.75% or an adjusted rate based upon the US prime rate.

 

The majority of the Company’s business is conducted in U.S. dollars. However, the Company does conduct certain transactions in other currencies, including Canadian dollars. Historically, fluctuations in foreign currency exchange rates have not materially affected the Company’s results of operations, and during the six months ended June 30, 2015 and 2014, the Company’s results of operations were not materially affected by fluctuations in foreign currency exchange rates.

 

Item 4.

Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

The Company’s management, with the participation of the Company’s Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of the Company’s disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) at the end of the period covered by this report. Based on that evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the Company’s disclosure controls and procedures as of the end of the period covered by this report are effective to provide reasonable assurance that the information required to be disclosed by the Company in reports filed under the Exchange Act is (i) recorded, processed, summarized and reported within the time periods specified in the U.S. Securities and Exchange Commission’s (the “Commission”) rules and forms, and (ii) accumulated and communicated to the Company’s management, including the Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding the disclosure.

 

 

Change in Internal Control over Financial Reporting

 

No change in the Company’s internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the Company’s most recent fiscal quarter that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.

 

Part II. Other Information

 

Item 1.

Legal Proceedings

 

There are no material pending legal proceedings.

 

Item 1A.

Risk Factors

 

Except for the historical information in this report, the matters contained in this report include forward-looking statements that involve risks and uncertainties. The Company’s operating results and financial condition have varied in the past and may in the future vary significantly depending on a number of factors. These factors, among others, could cause actual results to differ materially from those contained in forward-looking statements made in this report and presented elsewhere by management from time to time. Such factors may have a material adverse effect upon the Company’s business, results of operations and financial condition.

 

You should consider carefully the risk factors, together with all of the other information included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014. Each of these risk factors could adversely affect the Company’s business, results of operations and financial condition, as well as adversely affect the value of an investment in the Company’s common stock. There have been no material changes to the Company’s risk factors as previously disclosed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014.

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

 

There were no sales of equity securities during the six months ended June 30, 2015. See “Management’s Discussion and Analysis of Financial Condition and Results of Operations” Recent Developments.

 

Item 6.

Exhibits

 

Exhibits required by Item 601 of Regulation S-K are listed in the Exhibit Index hereto and include the following:

 

3.1	Third Amended and Restated Certificate of Incorporation of the Company, as amended. (Incorporated by reference to Exhibit 3.1 to the Company’s Form 10-Q quarterly report filed on August 7, 2014.)
3.2	Amended and Restated By-laws of the Company. (Incorporated by reference to Exhibit 3.2 to the Company’s Form 8-K current report filed on April 18, 2013.)
31.1	Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or 15a-14(a) under the Exchange Act.
31.2	Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or 15a-14(a) under the Exchange Act.
32.1	Certification Pursuant to 18 U.S.C. Section 1350 of principal executive officer and principal financial officer.
101.1	The following financial statements from Celator Pharmaceuticals Inc.’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, formatted in XBRL (eXtensible Business Reporting Language): (i) the Consolidated Balance Sheets at June 30, 2015 and December 31, 2014, (ii) the Consolidated Statements of Loss for the three and six months ended June 30, 2015 and 2014, (iii) Consolidated Statement of Shareholders’ Equity for the six months ended June 30, 2015, (iv) the Consolidated Statements of Cash Flows for the six months ended June 30, 2015 and 2014, and (v) Notes to Consolidated Financial Statements.

 

 

 

 

 

SIGNATURES

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

CELATOR PHARMACEUTICALS, INC.

Signature		Title		Date
/s/ Scott T. Jackson Scott T. Jackson		Chief Executive Officer and a Director (principal executive officer)		August 11, 2015
/s/ Fred M. Powell Fred M. Powell		Vice President and Chief Financial Officer (principal financial and accounting officer)		August 11, 2015

 

 

 

EXHIBIT INDEX 

 

Exhibit No.	Description
3.1	Third Amended and Restated Certificate of Incorporation of the Company, as amended. (Incorporated by reference to Exhibit 3.1 to the Company’s Form 10-Q quarterly report filed on August 7, 2014.)
3.2	Amended and Restated By-laws of the Company. (Incorporated by reference to Exhibit 3.2 to the Company’s Form 8-K current report filed on April 18, 2013.)
31.1	Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or 15a-14(a) under the Exchange Act.
31.2	Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or 15a-14(a) under the Exchange Act.
32.1	Certification Pursuant to 18 U.S.C. Section 1350 of principal executive officer and principal financial officer.
101.1	The following financial statements from Celator Pharmaceuticals Inc.’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, formatted in XBRL (eXtensible Business Reporting Language): (i) the Consolidated Balance Sheets at June 30, 2015 and December 31, 2014, (ii) the Consolidated Statements of Loss for the three and six months ended June 30, 2015 and 2014, (iii) Consolidated Statement of Shareholders’ Equity for the six months ended June 30, 2015, (iv) the Consolidated Statements of Cash Flows for the six months ended June 30, 2015 and 2014, and (v) Notes to Consolidated Financial Statements.