Bellicum Pharmaceuticals Reports First Quarter 2015 Financial Results
“In the first quarter, we made good progress recruiting our BPX-501
clinical trials and advancing multiple other controlled immunotherapy
programs toward the clinic,” said
Program and Corporate Updates:
- BPX-501: The Company continued to enroll its Phase 1/2 clinical trials with BPX-501 in the hematopoietic stem cell transplant (HSCT) setting. BP-004, an open label dose escalation study in pediatric patients with orphan inherited blood disorders and blood cancers, is evaluating whether genetically engineered BPX-501 T cells from haploidentical donors, administered following a T-depleted HSCT, are safe and can enhance immune reconstitution. BPX-501, which contains the CaspaCIDe® safety switch, allows for the elimination of T cells in vivo should they cause Graft-versus-host disease, and is designed to promote immune reconstitution and anti-viral activity more rapidly than conventional stem cell transplants.
-
BPX-701 / Leiden University Medical Center License Agreement: Bellicum
continued to advance development of its next-generation, proprietary T
cell receptor (TCR) therapy to treat solid tumors expressing the
preferentially-expressed antigen in melanoma, or PRAME. The Company
recently entered into a license agreement with
Leiden University Medical Center ,Netherlands , to develop, manufacture and commercialize high-affinity TCR product candidates against PRAME and an additional target. -
BPX-201: Enrollment continues in the last cohort of a Phase 1
clinical trial with a dendritic cell vaccine using Bellicum’s DeCIDe®
activation switch technology to treat metastatic castrate-resistant
prostate cancer. The Company is currently preparing for further
development of BPX-201 in combination with a checkpoint inhibitor.
- Preclinical CAR-T Programs: Bellicum is leveraging the capabilities it has gained in the development and manufacture of BPX-501 to develop its next-generation controllable CAR-T therapies. BPX-401 incorporates the CaspaCIDe safety switch for the treatment of blood cancers overexpressing CD19, including acute lymphocytic leukemia, chronic lymphocytic leukemia, and certain non-Hodgkin’s lymphomas. BPX-601, a CAR-T therapy with the Company’s GoCAR-T™ activation switch, is designed to treat solid tumors overexpressing PSCA, including some prostate, pancreatic, ovarian, bladder, esophageal and gastric cancers. The Company is also evaluating additional antigen targets, novel molecular switches, and approaches to off-the-shelf delivery of cellular immunotherapies.
First Quarter 2015 Financial Results:
Bellicum reported a net loss of
Grant revenues were
Research and development expenses were
General and administrative expenses were
About
Bellicum is a clinical stage biopharmaceutical company focused on discovering and developing novel cellular immunotherapies for various forms of cancer, including hematological cancers and solid tumors, as well as orphan inherited blood disorders. The Company is using its proprietary Chemical Induction of Dimerization, or CID, technology platform to engineer and control components of the immune system in real time. The Company is developing next-generation product candidates in some of the most important areas of cellular immunotherapy, including hematopoietic stem cell transplantation, or HSCT, CAR T cell therapy, and dendritic cell vaccines. More information can be found at www.bellicum.com.
*CaspaCIDe® and DeCIDe® are
trademarks registered with the U.S. Patent and Trademark Office.
CIDeCAR™ and GoCAR-T™ are trademarks of
Forward-Looking Statement
This press release contains forward-looking statements for purposes
of the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Bellicum may, in some cases, use terms such as
"predicts," "believes," "potential," "proposed," "continue," “designed,”
"estimates," "anticipates," "expects," "plans," "intends," "may,"
"could," "might," "will," "should" or other words that convey
uncertainty of future events or outcomes to identify these
forward-looking statements. Forward-looking statements include
statements regarding our intentions, beliefs, projections, outlook,
analyses or current expectations concerning, among other things: the
timing of our clinical trials, including the rate and progress of
enrollment in such trials, our research and development activities and
expenses relating to BPX-501, BPX-401, BPX-601, BPX-701 and BPX-201 and
the potential applications and effectiveness of our product candidates,
including as compared to other treatment options. Various factors may
cause differences between Bellicum’s expectations and actual results as
discussed in greater detail in Bellicum’s filings with the
BELLICUM PHARMACEUTICALS, INC. | ||||||||
Unaudited Condensed Balance Sheets | ||||||||
(in thousands) | ||||||||
March 31, | December 31, | |||||||
2015 | 2014 | |||||||
Cash and cash equivalents | $ | 183,638 | $ | 191,602 | ||||
Receivables and other current assets | 1,373 | 1,620 | ||||||
Property and equipment, net | 3,164 | 2,427 | ||||||
Other assets, net | 97 | 145 | ||||||
Total assets | $ | 188,272 | $ | 195,794 | ||||
Current Liabilities: | ||||||||
Accounts payable and other accrued liabilities | $ | 2,194 | $ | 3,371 | ||||
Other current liabilities | 454 | 265 | ||||||
Long-term Liabilities: | ||||||||
Other liabilities, net of current portion | 263 | 522 | ||||||
Total Stockholder's equity | 185,361 | 191,636 | ||||||
Total liabilities and stockholder's equity | $ | 188,272 | $ | 195,794 | ||||
BELLICUM PHARMACEUTICALS, INC. | ||||||||
Unaudited Condensed Statements of Operations | ||||||||
(in thousands, except share and per share amounts) | ||||||||
Three Months Ended | ||||||||
March 31, | ||||||||
2015 | 2014 | |||||||
Grant Revenues | $ | 107 | $ | 552 | ||||
Operating Expenses: | ||||||||
Research and development | 5,718 | 2,389 | ||||||
General and administrative | 2,197 | 440 | ||||||
Total operating expenses | 7,915 | 2,829 | ||||||
Operating loss | (7,808 | ) | (2,277 | ) | ||||
Interest expense, net | 50 | (13 | ) | |||||
Net Loss | $ | (7,758 | ) | $ | (2,290 | ) | ||
Preferred stock dividends | - | (540 | ) | |||||
Net loss attributable to common shareholders | $ | (7,758 | ) | $ | (2,830 | ) | ||
Net loss per share attributable to common | ||||||||
shareholders, basic and diluted | $ | (0.30 | ) | $ | (1.52 | ) | ||
Weighted average common shares outstanding, basic and diluted | 26,259,392 | 1,863,350 |
Source:
Investors:
Bellicum Pharmaceuticals
Alan Musso, CFO,
832-384-1116
amusso@bellicum.com
or
Media:
BMC
Communications
Brad Miles, 646-513-3125
bmiles@bmccommunications.com