Interim data for BPX-601 accepted for
presentation at upcoming American Society of Clinical Oncology
(ASCO) Annual Meeting
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 first quarter 2019 and provided an operational
update.
“We made strong progress in advancing our programs in the first
quarter,” said Rick Fair, President and Chief Executive Officer of
Bellicum Pharmaceuticals. “In our GoCAR-T® pipeline, we received
acceptance of our abstract with new data from the BPX-601 Phase 1/2
clinical trial for the upcoming ASCO Annual Meeting, and made
progress toward IND clearance and Phase 1 study start for BPX-603
later this year. In addition, we remain on track to announce
topline results from the rivo-cel pediatric registrational trial by
the end of the second quarter.”
PROGRAM HIGHLIGHTS AND CURRENT UPDATES
BPX-601 GoCAR-T
- Bellicum presented initial clinical data from the
dose-escalation phase of the Phase 1/2 study of BPX-601 at the
Gastrointestinal Cancers Symposium in January that showed a
promising safety profile. Additionally, in several patients
reported, iMC activation from the administration of rimiducid led
to enhanced cell expansion, prolonged cell persistence, and early
evidence of clinical activity and disease control. The trial
protocol was amended to incorporate a standard lymphodepletion
conditioning regimen consisting of cyclophosphamide/fludarabine
(Cy/Flu). Updated data from this study—including patients from this
Cy/Flu cohort—have been accepted for presentation at ASCO. As a
next step in the study, Bellicum plans to enroll an additional
cohort to evaluate repeat rimiducid dosing to re-activate iMC over
time, which is intended to deepen and extend the treatment effect.
Initial results from this cohort are expected in late 2019.
Controllable Dual-Switch GoCAR-T Product
Candidates
- Bellicum believes that its next-generation dual-switch GoCAR-T
technology may enhance efficacy relative to current generation
CAR-T therapy through iMC activation while enabling clinicians to
manage certain treatment-emergent toxicities with CaspaCIDe®. The
company expects to complete an IND application and initiate a Phase
1 clinical trial for BPX-603, a dual-switch GoCAR-T targeting
HER2-expressing solid tumors, later this year. The company also
expects to submit an IND application by the end of the year for
BPX-802, a dual-switch GoCAR-T product candidate targeting an
antigen expressed in hematological malignancies.
Rivo-cel
- The company expects to report topline results from the
pediatric BP-004 study in the second quarter of 2019 and plans to
submit Marketing Authorisation Applications (MAAs) for rivo-cel and
rimiducid by year-end.
- Patient recruitment is ongoing in THRIVE, a pivotal randomized
global Phase 2/3 clinical trial of rivo-cel in adult and adolescent
patients 12 years and older with intermediate and high-risk acute
myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
First Quarter 2019 Financial Results
Cash Position and Guidance: Bellicum reported
cash, restricted cash and investments totaling $78.1 million as of
March 31, 2019, compared to $98.0 million at December 31, 2018.
Based on current operating plans, Bellicum expects that current
cash resources will be sufficient to meet operating requirements
through the end of 2019. During the first quarter, Bellicum
utilized its at the market financing facility selling 1.4 million
shares for net cash proceeds of $4.6 million.
R&D Expenses: Research and development
(R&D) expenses were $16.8 million for the first quarter of
2019, compared to $16.5 million for the first quarter of 2018. The
higher expenses in the first quarter of 2019 resulted primarily
from higher expenditures related to the GoCAR-T platform including
initiation of additional clinical sites and costs related to IND
filing.
G&A Expenses: General and administrative
(G&A) expenses were $7.5 million for the first quarter of 2019
compared to $5.7 million during the comparable period in 2018. The
higher expenses in the first quarter 2019 relative to the
comparable period in 2018 were primarily due to increased personnel
related costs due to hiring additional employees as well as
increased costs related to commercialization preparation
activities.
Net Loss: Bellicum reported a net loss of $24.5
million for the first quarter of 2019 compared to a net loss of
$22.8 million for the first quarter of 2018. The results included
non-cash, share-based compensation charges of $2.1 million and $3.6
million for the first quarter of 2019 and 2018, respectively.
Shares Outstanding: At April 30, 2019, Bellicum
had 46,009,066 shares of common stock outstanding.
About BPX-601
BPX-601, the company’s first GoCAR-T® product candidate,
incorporates iMC, Bellicum’s inducible co-activation domain. iMC
(inducible MyD88/CD40) is designed to provide a powerful boost to T
cell proliferation and persistence and enable the CAR-T to override
key immune inhibitory mechanisms, including PD-1 and TGF-beta.
BPX-601 is being evaluated as a treatment for solid tumors
expressing prostate stem cell antigen (PSCA), including pancreatic,
gastric, and prostate cancers.
About Rivo-cel (BPX-501)
Rivo-cel™ (rivogenlecleucel) is an allogeneic polyclonal T-cell
product designed to accelerate immune recovery after HSCT and to
reduce relapse of leukemia following a stem cell transplant. The
cell treatment contains a diverse repertoire of T cells which may
contribute to a robust graft vs. leukemia effect. Rivo-cel’s
anti-infective benefits may also reduce morbidity and mortality, as
patients are highly susceptible to infection following a
transplant. The product’s CaspaCIDe® safety switch enables this
approach by allowing physicians to reduce the number of
alloreactive cells in the event of uncontrolled GvHD. Rivo-cel
addresses a major unmet need in adult and pediatric leukemia,
lymphoma and inherited blood disease patients following a
haploidentical stem cell transplant.
About Bellicum Pharmaceuticals
Bellicum is a clinical stage biopharmaceutical company striving
to deliver cures through controllable cell therapies. The company’s
next-generation product candidates are differentiated by powerful
cell signaling technologies designed to produce more effective
CAR-T and allogeneic T cell therapies. Bellicum’s lead GoCAR-T®
candidate, BPX-601, is designed to be a more efficacious CAR-T cell
product capable of overriding key immune inhibitory mechanisms.
Bellicum’s rivo-cel product candidate is an allogeneic polyclonal T
cell therapy that has shown promising clinical trial results in
reducing leukemia relapse after a stem cell transplant. More
information can be found at www.bellicum.com.
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: our research and development activities
relating to rivo-cel, rimiducid, BPX-601, BPX-603, BPX-802, and
other cell therapy programs; our pipeline candidates’
effectiveness, possible ranges of application and potential safety
and curative effects in the treatment of diseases, including as
compared to other treatment options and competitive therapies; the
timing and success of our current and planned clinical trials,
including the timing of receipt of data from such clinical trials
and the timing of our reports of such data; the expansion of or
changes to our ongoing clinical trials to new indications and
diseases; the timing and success of regulatory filings for rivo-cel
and rimiducid including our European Marketing Authorisation
Applications (MAA); the speed and effectiveness of our preparations
for potential commercialization in Europe if the MAAs are approved;
and our cash uses and cash runway. 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 quarterly report on
Form 10-Q for the three months ended March 31, 2019 and our
annual report on Form 10-K the year ended December 31, 2018.
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) |
|
|
|
|
|
|
|
|
|
|
|
March
31 |
|
|
December
31 |
|
|
|
|
2019 |
|
|
2018 |
|
Current Assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
42,274 |
|
$ |
43,695 |
|
Investment securities, available-for-sale,
short-term |
|
|
31,210 |
|
|
49,304 |
|
Receivables and other current assets |
|
|
3,201 |
|
|
2,296 |
|
|
|
|
|
|
|
|
|
Non-Current Assets: |
|
|
|
|
|
|
|
Property and equipment, net |
|
|
19,189 |
|
|
20,878 |
|
Right-of-use assets |
|
|
4,655 |
|
|
- |
|
Restricted cash |
|
|
4,585 |
|
|
4,973 |
|
Other assets |
|
|
3,054 |
|
|
355 |
|
Total Assets |
|
$ |
108,168 |
|
$ |
121,501 |
|
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
|
Accounts payable and other accrued
liabilities |
|
$ |
12,416 |
|
$ |
12,363 |
|
Other current liabilities |
|
|
3,749 |
|
|
3,441 |
|
|
|
|
|
|
|
|
|
Long-Term Liabilities: |
|
|
|
|
|
|
|
Other liabilities, net of current portion |
|
|
41,143 |
|
|
37,219 |
|
|
|
|
|
|
|
|
|
Total Stockholders' Equity |
|
|
50,860 |
|
|
68,478 |
|
Total Liabilities and Stockholders'
Equity |
|
$ |
108,168 |
|
$ |
121,501 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BELLICUM PHARMACEUTICALS, INC. |
Unaudited Condensed
Consolidated Statements of Operations |
(in
thousands, except share and per share amounts) |
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
March 31, |
|
|
|
2019 |
|
|
2018 |
|
|
|
|
|
|
|
|
|
Grant Revenues |
|
$ |
516 |
|
$ |
154 |
|
|
|
|
|
|
|
|
|
Operating Expenses: |
|
|
|
|
|
|
|
Research and development |
|
|
16,818 |
|
|
16,536 |
|
License fees |
|
|
30 |
|
|
30 |
|
General and administrative |
|
|
7,536 |
|
|
5,692 |
|
Total operating expenses |
|
|
24,384 |
|
|
22,258 |
|
Operating loss |
|
|
(23,868) |
|
|
(22,104) |
|
|
|
|
|
|
|
|
|
Interest expense, net of interest income |
|
|
(660) |
|
|
(736) |
|
Net loss attributable to common
shareholders |
|
$ |
(24,528) |
|
$ |
(22,840) |
|
Net loss per share attributable to
common shareholders, basic and diluted |
|
$ |
(0.55) |
|
$ |
(0.68) |
|
Weighted average common shares outstanding, basic
and diluted |
|
|
44,243,896 |
|
|
33,456,446 |
|
|
|
|
|
|
|
|
|
Source: Bellicum Pharmaceuticals
Investors:Robert H. Uhl Managing Director Westwicke IR
858-356-5932 Robert.uhl@westwicke.com
Media: Jim Heins Senior Vice President Westwicke PR
203-682-8251 james.heins@icrinc.com
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