Bellicum Pharmaceuticals, Inc. (NASDAQ:BLCM), a leader in
developing novel, controllable cellular immunotherapies for cancers
and orphan inherited blood disorders, today reported financial
results for the third quarter ended September 30, 2017, and
provided an update on recent developments.
“We made good progress advancing our pipeline in the third
quarter. Enrollment in our clinical program for BPX-501 remains on
track and we progressed our plans for future trials in adult AML
and a pediatric orphan blood disorder,” said Rick Fair, Bellicum’s
President & Chief Executive Officer. “On BPX-601, we modified
our Phase 1 trial to accelerate evaluation of our first clinical
GoCAR-T candidate, and we look forward to reporting preliminary
results next year. Finally, we continued to advance several
exciting preclinical programs, leveraging our dual-switch
controllable cell therapy platform.”
PROGRAM HIGHLIGHTS AND CURRENT UPDATES
BPX-501Adjunct T-cell therapy incorporating the
CaspaCIDe® safety switch, administered after a haploidentical
hematopoietic stem cell transplant (haplo-HSCT), to improve
outcomes and reduce mortality
- Bellicum Continues to Advance its BPX-501
ProgramEnrollment in the EU BP-004 clinical trial remains
on track to be complete by the end of 2017. Bellicum has also
initiated C-004, an observational trial in pediatric patients
receiving transplants from matched unrelated donors (MUD) without
BPX-501. The outcomes of both trials could form the basis for
filings of European Marketing Authorization Applications for
BPX-501 and rimiducid. A BPX-501 abstract, highlighting data on
immune reconstitution from the EU BP-004 clinical trial, has been
accepted for an oral presentation at the upcoming 59th Annual
Meeting of the American Society of Hematology (ASH) in
December.
- Company Prepares for Additional
BPX-501 Trials in U.S.Planning is ongoing for two
additional trials of BPX-501 to expand the eligible patient
population and support potential U.S. registration. These trials
are being developed in adult patients with acute myeloid leukemia
(AML) and in a distinct orphan inherited blood disorder patient
population.
BPX-601Novel GoCAR-T® product candidate
designed with the proprietary iMC activation switch to improve
efficacy
- Phase 1 BPX-601 Clinical Trial
ProgressingEnrollment and treatment is currently ongoing
in the Company’s Phase 1 trial in nonresectable pancreatic cancer
patients who test positive for prostate stem cell antigen (PSCA).
Based on data from the initial three treated patients, the
Company—with support from the principal investigator and the
FDA—amended the study protocol to allow activation of the iMC
switch seven days following the administration of BPX-601 versus
the previous 30-day schedule. This will enable an earlier
evaluation of the first clinical experience with GoCAR-T, the
Company’s platform to enhance and control CAR-T cell activation,
proliferation, and survival.
BPX-701 High affinity T-cell receptor
(TCR) product candidate designed with the CaspaCIDe® safety
switch
- Phase 1 BPX-701 Clinical Trial Progressing
Enrollment and treatment is currently ongoing in the Company’s
Phase 1 clinical trial in patients with refractory or relapsed AML
and myelodysplastic syndromes (MDS) who test positive for
preferentially-expressed antigen in melanoma (PRAME).
CD19 ProgramBellicum is working with academic
collaborators to evaluate the benefit of CaspaCIDe® in managing
serious toxicities associated with CD19 CAR-T cells
- In collaboration with Ospedale Pediatrico Bambino Gesù (OPBG),
a leading European pediatric research center and hospital, a Phase
1 clinical trial of a CaspaCIDe-enabled CD19 CAR-T is expected to
begin in the fourth quarter.
Preclinical Programs
- At ASH 2017, the Company will present preclinical results of
its controllable CAR-T technology in three poster presentations,
including a study evaluating Bellicum’s dual-switch CAR-T cells
targeting CD123. The data will further support the potential of the
Company’s technology platform to control cells in vivo and improve
the benefit / risk profile of adoptive cell therapies.
Third Quarter and Nine Months Ended September 30,
2017 Financial Results
Bellicum reported a net loss of $23.4 million for the
third quarter of 2017 and $69.9 million for the nine months
ended September 30, 2017, compared to a net loss of $17.7
million and $49.3 million for the comparable periods
in 2016. The results included non-cash, stock-based compensation
charges of $3.7 million and $10.2 million for
the third quarter and nine months ended September 30,
2017, and $3.1 million and $9.2
million for the comparable periods in 2016.
As of September 30, 2017, cash and investments
totaled $118.6 million. Bellicum expects that it will end 2017
with approximately $90 to $95 million in cash, cash
equivalents and investments, and continues to expect that current
cash resources will be sufficient to meet operating requirements
through 2018.
Research and development expenses were $18.1
million and $51.4 million for the three and nine
months ended September 30, 2017, respectively, compared
to $13.3 million and $36.2 million during the
comparable periods in 2016. The higher expenses in the 2017 periods
were primarily due to an increase in clinical development and
manufacturing costs due to increased enrollment in clinical trials,
principally BP-004, and increased personnel expenses, overhead
charges and manufacturing facility start-up costs.
General and administrative expenses were $4.6
million and $16.0 million for the three and nine
months ended September 30, 2017, respectively, compared
to $4.3 million and $12.7 million during the
comparable periods in 2016. The higher expenses in the 2017 periods
were primarily due to the Company’s overall growth, including an
increase in personnel related costs, principally due to hiring
additional employees and severance costs, higher facility costs and
increased legal, accounting and travel expenses.
About BPX-501 BPX-501 is an adjunct T-cell
therapy administered after allogeneic HSCT, comprising genetically
modified donor T cells incorporating Bellicum’s
CaspaCIDe® safety switch. It is designed to provide a safety
net to eliminate alloreactive BPX-501 T cells (via administration
of activator agent rimiducid) should uncontrollable GvHD occur.
This could enable physicians to more safely perform allogeneic stem
cell transplants by administering BPX-501 engineered T cells to
speed immune reconstitution, provide control over viral infections
and enhance Graft-versus-leukemia effect, without unacceptable GvHD
risk. The ongoing BP-004 clinical study of BPX-501 is being
conducted at transplant centers in the U.S.
and Europe.
About Bellicum Pharmaceuticals Bellicum is
a clinical stage biopharmaceutical company focused on discovering
and developing cellular immunotherapies for cancers and orphan
inherited blood disorders. Bellicum is using its proprietary
Chemical Induction of Dimerization (CID) technology platform to
engineer and control components of the immune system. Bellicum is
developing next-generation product candidates in some of the most
important areas of cellular immunotherapy, including hematopoietic
stem cell transplantation (HSCT), and CAR-T and TCR cell therapies.
More information can be found at www.bellicum.com.
Forward-Looking StatementThis 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:
our research and development activities relating to BPX-501,
BPX-601, BPX-701, rimiducid, CaspaCIDe, iMC, dual switch, CAR-T and
TCR programs; the effectiveness of BPX-501, BPX-601 and BPX-701,
their possible ranges of application and potential curative effects
and safety in the treatment of diseases, including as compared to
other treatment options and competitive therapies; the timing and
success of our clinical trials, including our BP-004 study and
observational trials; the rate and progress of enrollment in our
clinical trials for BPX-501, BPX-601 and BPX-701, including our
planned registration trials for BPX-501 and rimiducid; the timing
of regulatory filings for BPX-501 and rimiducid; our research and
development activities relating to our GoCAR-T and GoTCR
technologies, and our collaborations with academic institutions.
Various factors may cause differences between Bellicum’s
expectations and actual results as discussed in greater detail
under the heading “Risk Factors” in Bellicum’s filings with the
Securities and Exchange Commission, including without limitation
our annual report on Form 10-K for the year ended December 31, 2016
and our report on Form 10-Q for the quarter ended March 31, 2017.
Any forward-looking statements that Bellicum makes in this press
release speak only as of the date of this press release. Bellicum
assumes no obligation to update our forward-looking statements
whether as a result of new information, future events or otherwise,
after the date of this press release.
BELLICUM PHARMACEUTICALS, INC. |
|
|
Unaudited
Condensed Consolidated Balance Sheets |
|
|
(in thousands) |
|
|
|
|
|
|
September 30, |
December 31, |
|
2017 |
2016 |
Current Assets: |
|
|
Cash and cash
equivalents |
$ |
54,468 |
$ |
33,140 |
Investment securities,
available-for-sale, short-term |
58,608 |
70,632 |
Receivables and other
current assets |
2,582 |
1,838 |
|
|
|
Non-Current
Assets: |
|
|
Investment securities,
available-for-sale, long-term |
2,556 |
- |
Property and equipment,
net |
26,252 |
16,504 |
Restrited cash |
2,947 |
9,640 |
Other assets, net |
358 |
283 |
Total
assets |
$ |
147,771 |
$ |
132,037 |
|
|
|
Current
Liabilities: |
|
|
Accounts payable and
other accrued liabilities |
$ |
11,712 |
$ |
12,986 |
Current maturities of
long-term debt |
6,913 |
1,787 |
Other current
liabilities |
388 |
340 |
|
|
|
Long-Term
Liabilities: |
|
|
Long-term debt |
23,839 |
18,436 |
Other liabilities, net
of current portion |
1,802 |
1,914 |
|
|
|
Total Stockholders'
Equity |
103,117 |
96,574 |
Total
liabilities and stockholders' equity |
$ |
147,771 |
$ |
132,037 |
|
|
|
BELLICUM PHARMACEUTICALS, INC. |
|
|
|
|
Unaudited
Condensed Consolidated Statements of Operations |
|
|
|
|
(in thousands, except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
Nine Months Ended |
|
September 30, |
September 30, |
|
2017 |
2016 |
2017 |
2016 |
|
|
|
|
|
Grant Revenues |
$ |
126 |
$ |
114 |
$ |
254 |
$ |
307 |
|
|
|
|
|
Operating
Expenses: |
|
|
|
|
Research
and development |
18,101 |
13,290 |
51,355 |
36,179 |
License
fees |
151 |
- |
849 |
280 |
General
and administrative |
4,579 |
4,252 |
15,992 |
12,715 |
Total operating
expenses |
22,831 |
17,542 |
68,196 |
49,174 |
Operating
loss |
(22,705) |
(17,428) |
(67,942) |
(48,867) |
|
|
|
|
|
Interest expense,
net |
(726) |
(291) |
(1,919) |
(436) |
Net
loss |
$ |
(23,431) |
$ |
(17,719) |
$ |
(69,861) |
$ |
(49,303) |
|
|
|
|
|
Net loss
per share attributable to common shareholders, basic and
diluted |
$ |
(0.71) |
$ |
(0.66) |
$ |
(2.24) |
$ |
(1.83) |
Weighted average common
shares outstanding, basic and diluted |
33,178,611 |
26,966,630 |
31,204,521 |
26,919,984 |
Source: Bellicum Pharmaceuticals
Investors:
Bellicum Pharmaceuticals, Inc.
Alan Musso, CFO
832-384-1116
amusso@bellicum.com
Media:
BMC Communications
Brad Miles
646-513-3125
bmiles@bmccommunications.com
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