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

Aug 11, 2015, 16:01 ET from Celator Pharmaceuticals, Inc.

EWING, N.J., Aug. 11, 2015 /PRNewswire/ -- Celator Pharmaceuticals, Inc. (Nasdaq: CPXX), a biopharmaceutical company that is transforming the science of combination therapy and developing products to improve patient outcomes in cancer, today reported business highlights and financial results for the second quarter ended June 30, 2015.

"We capped off a very busy second quarter by reporting positive induction response rate data in the Phase 3 study of VYXEOS™ (CPX-351) in patients with high-risk (e.g. secondary) acute myeloid leukemia (AML)," said Scott Jackson, chief executive officer of the Company. "We believe response is an important surrogate for overall survival and clinical benefit in this patient population. We intend to build on that momentum as we advance our broader clinical development program, report data on CombiPlex® technology platform studies, and increase pre-commercial activities."  Mr. Jackson continued, "Data on overall survival are expected in the first quarter of 2016, with an NDA submission planned for the third quarter of 2016.  If approved, VYXEOS will be well-positioned to become the foundation of care for high-risk AML patients."   

Second Quarter 2015 and Recent Highlights:

  • The Company reported positive induction response rate results from the Phase 3 study of CPX-351 in patients with high-risk (e.g. secondary) AML.
  • The FDA granted approval of the brand name VYXEOS™ for CPX-351.
  • Enrollment was completed in 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 (ALL), and myelodysplastic syndrome (MDS).
  • As part of the Company's existing $5 million Phase 3 partnership with the Leukemia & Lymphoma Society®, Celator achieved a milestone payment of $900,000 based on positive induction response rate data from the Phase 3 study, thereby bringing the total amount received to date to $4.9 million.
  • At the Company's Analyst and Investor Day, management presented an overview of the company's growth strategy which included VYXEOS and our proprietary technology platform, CombiPlex.  Key thought leaders, Gail Roboz, M.D. and Bruno C. Medeiros, M.D., discussed AML and VYXEOS.  In addition, Anthony Tolcher, M.D., presented on the challenges and opportunities of combining molecularly targeted agents which may be addressed by CombiPlex. The presentations are on the Company's website at: http://www.celatorpharma.com/#!events-and-presentations/c1iw5
  • The Company announced that enrollment had commenced in an investigator-initiated Phase 2 clinical study, at MD Anderson Cancer Center, evaluating CPX-351 as a treatment for patients with newly diagnosed AML at high risk for induction treatment mortality.
  • Based on encouraging safety and efficacy results, a patient cohort was expanded in an investigator-initiated study, being conducted at both the Fred Hutchinson Cancer Research Center and Stanford University, evaluating CPX-351 in patients with either untreated MDS or AML at high-risk of treatment-related mortality.
  • Data were presented describing the effects of combining CPX-351 with traditional chemotherapy and novel molecularly targeted agents intended for use in treating AML and other blood cancers at the American Association for Cancer Research (AACR) Annual Meeting. 

Financial Highlights:

  • Cash Position: Cash and cash equivalents as of June 30, 2015 were $28.5 million, compared to $32.4 million as of December 31, 2014. The decrease of $3.9 million was primarily due to $9.0 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 March 31, 2015 were $32.9 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.
  • R&D Expenses: Research and development expenses were $3.5 million and $6.2 million for the three and six months ended June 30, 2015, as compared to $2.9 million and $5.9 million for the same periods in 2014. The increase in R&D expenses in the comparable three-month periods was primarily due to increases in outsourced clinical trial and regulatory activities related to CPX-351 and additional manufacturing costs. The increase between the comparable six-month periods was primarily due to increases in outsourced clinical trial and regulatory activities related to CPX-351 and were partially offset by reduced manufacturing and research costs.
  • G&A Expenses: General and administrative expenses were $2.0 million and $3.8 million for the three and six months ended June 30, 2015, as compared to $1.7 million and $3.6 million for the same periods of 2014. The increases were primarily attributable to increases in investor relations, professional fees and public company-related costs. These increases were offset by decreases in consulting costs associated with commercial development.
  • Net Loss: Net loss was $5.0 and $9.7 million for the three and six months ended June 30, 2015, as compared to $4.8 million and $9.1 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 second 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 97541722. 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, CPX-351 (a liposomal formulation of cytarabine:daunorubicin) for the treatment of acute myeloid leukemia; CPX-1 (a liposomal formulation of irinotecan:floxuridine) for the treatment of colorectal cancer; a preclinical stage product candidate, CPX-8 (a hydrophobic docetaxel prodrug nanoparticle formulation), being studied by the National Cancer Institute's Nanotechnology Characterization Laboratory.  The company is advancing the CombiPlex platform and broadening its application to include molecularly targeted therapies and epigenetic modulators.

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 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 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 clinical studies, enrollment in clinical studies, availability of data from ongoing clinical studies, whether clinical study results for CPX-351 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 and other filings by Celator with the U.S. Securities and Exchange Commission.

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

 

 

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

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

Investors: Adam Krop The Trout Group 646-378-2963 akrop@troutgroup.com

SOURCE Celator Pharmaceuticals, Inc.



RELATED LINKS

http://www.celatorpharma.com