Bellicum Pharmaceuticals, Inc. (Nasdaq: BLCM), a leader in
developing novel, controllable cellular immunotherapies for
cancers, today reported financial results for the fourth quarter
and full year 2021 and provided an operational update.
“Bellicum made great progress in the past year in the clinical
development of our GoCAR-T® cell therapies and in broadening the
impact of our technology via licensing,” said Rick Fair, President
and Chief Executive Officer. “In 2021, we opened the BPX-601 trial
in prostate cancer and reported a confirmed response in the first
cohort treated, initiated the BPX-603 trial in HER2+ solid tumors,
signed licensing agreements for our CaspaCIDe safety switch for use
in six new CAR-T and CAR-NK programs, and raised additional capital
expected to fund the company beyond our next data milestones for
our GoCAR-T programs. The Omicron COVID-19 variant had a
significant impact on our clinical trial sites and trial enrollment
over the last two quarters, but we have recently seen an uptick in
site activation and screening activity as cases decline. We believe
we are well positioned to further demonstrate the value of GoCAR-T
in the coming year.”
Program Highlights and Current Updates
BPX-601 GoCAR-T®
- Enrollment in the Phase 1/2 dose escalation clinical trial in
patients with previously treated metastatic castration-resistant
prostate cancer (mCRPC) is ongoing. On December 6, 2021, Bellicum
provided an interim data update and reported that one of the first
three mCRPC patients treated in the study achieved a confirmed
partial response by RECIST v1.1 criteria. Additionally, no
dose-limiting toxicities were observed. The company expects to
present a data update on BPX-601 in the first quarter of 2023.
BPX-603 GoCAR-T
- Enrollment is ongoing in the Phase 1/2 clinical trial for
BPX-603 in patients with solid tumors that express human epidermal
growth factor 2 (HER2), including breast, endometrial, ovarian,
gastric, and colorectal cancers. BPX-603 is the company’s first
dual-switch GoCAR-T product candidate that incorporates Bellicum’s
iMC activation and CaspaCIDe® safety switch technologies. On
December 6, 2021, the company reported initial Phase 1 data from
this trial demonstrating a favorable safety profile in the first
dose cohort of the study. The company expects to present a data
update on BPX-603 in the first half of 2023.
Private Placement Completed
- As previously reported, Bellicum entered into an agreement for
a $35 million private placement of equity securities in December
2021 with two biotechnology specialist investment funds. Proceeds
from the financing are expected to extend cash runway into the
second quarter of 2023 and will be used to support ongoing clinical
development of BPX-601 and BPX-603.
Regained Compliance with Nasdaq
- On December 10, 2021, Nasdaq notified Bellicum that it had
regained compliance with Listing Rule 5550(b)(1), which requires
stockholders’ equity of at least $2.5 million for continued listing
of the company’s common stock. Accordingly, the Company is now in
compliance with the continued listing requirements of The Nasdaq
Capital Market.
Charity Scripture Named Chief Development
Officer
- Dr. Scripture rejoined Bellicum in a full-time capacity
effective December 1, 2021 after spending the previous year as VP,
Business and Development Operations at ACELYRIN, a private
biopharmaceutical company. Previously, Dr. Scripture was Vice
President, Clinical & Medical Affairs at Bellicum. Prior to
joining Bellicum, Dr. Scripture held clinical development
leadership positions at AbbVie/Stemcentrx and Pharmacyclics, and
spent almost a decade with Amgen in oncology clinical development
and medical affairs.
Financial Results for the Fourth Quarter and Year Ended
December 31, 2021
Revenues: Bellicum reported revenue of $0.5
million and $6.2 million for the fourth quarter and year ended
December 31, 2021, respectively, compared to $0.5 million during
each of the comparable periods in 2020. The increase in revenues
was due to agreements executed with external parties during the
year. In the first quarter of 2021, Bellicum entered into a
multi-year supply agreement with Takeda Development Center
Americas, Inc. for the supply of rimiducid for potential use in
clinical trials of TAK-007. Initial clinical trial supply was
fulfilled in the second quarter of 2021 generating revenue of $0.7
million. Revenues from up-front and annual maintenance payments
related to CaspaCIDe licensing agreements were $0.5 million and
$5.5 million for the fourth quarter and full year 2021, compared to
$0.5 million in 2020.
R&D Expenses: Research and development
expenses were $4.0 million and $23.6 million for the fourth quarter
and year ended December 31, 2021, respectively, compared to $8.7
million and $39.1 million for the fourth quarter and year ended
December 31, 2020, respectively. The decrease in R&D expenses
for the fourth quarter and year ended December 31, 2021, compared
to the prior year, was primarily due to reduced expenses related to
rivo-cel related activities, the sale of the manufacturing
facility, and the reduction in force that was implemented in the
fourth quarter of 2020, partially offset by an increase in expenses
related to Bellicum’s GoCAR-T programs. This resulted in $12.3
million reduction in employee-related expenses and a $3.2 million
reduction in other R&D expenses.
G&A Expenses: General and administrative
expenses were $1.6 million and $7.0 million for the fourth quarter
and year ended December 31, 2021, respectively, compared to $3.4
million and $15.5 million for the comparable periods in 2020. The
decrease in G&A expenses for the fourth quarter and year ended
December 31, 2021, compared to the year ended December 31, 2020,
was primarily due to the reduction in force that reduced
employee-related expenses by $6.8 million as well as the reduction
in rivo-cel related commercialization activities that reduced
expenses by $1.7 million.
Loss from Operations: Bellicum reported a loss
from operations of $5.1 million and $24.9 million for the fourth
quarter and year ended December 31, 2021, respectively, compared to
$13.0 and $51.7 million for the comparable periods in 2020. The
results for the year ended December 31, 2021 include loss on
dispositions of $0.5 million whereas for the year ended December
31, 2020, a gain on dispositions of $3.7 million was
recognized.
Net Income/Loss: Bellicum reported net income
of $2.5 million and a net loss of $9.7 million for the fourth
quarter and year ended December 31, 2021, respectively, compared to
net income of $18.8 million and a net loss $7.7 million for the
fourth quarter and year ended December 31, 2020, respectively. The
results included gain from change in fair value of warrant
derivative liabilities of $7.6 million and $15.1 million for the
fourth quarter and year ended December 31, 2021, respectively.
Shares Outstanding: As of March 21, 2022,
Bellicum had 8,552,207 shares of common stock and 452,000 shares of
preferred stock outstanding. Each share of preferred stock is
convertible into 10 shares of common stock.
Cash Position and Guidance: Bellicum reported
cash and cash equivalents and restricted cash totaling $47.7
million as of December 31, 2021, compared to $37.0 million as of
December 31, 2020. Based on current operating plans, Bellicum
expects that current cash resources will be sufficient to meet
operating requirements into the second quarter of 2023.
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 cell therapies. Bellicum’s GoCAR-T® product candidates,
BPX-601 and BPX-603, are designed to be more efficacious CAR-T cell
products capable of overriding key immune inhibitory mechanisms.
More information about Bellicum can be found at www.bellicum.com or
follow us on Twitter or LinkedIn.
Forward-Looking Statements
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 Bellicum’s intentions,
beliefs, projections, outlook, analyses or current expectations
concerning, among other things: Bellicum’s positioning for
demonstrating the value of GoCAR-T in the coming year; the timing
of data updates from Bellicum’s ongoing BPX-601 and BPX-603
clinical trials; the use of proceeds from Bellicum’s December 2021
private placement; and Bellicum’s expected cash runway. Various
factors may cause differences between Bellicum’s expectations and
actual results, including, among others, the impact of the COVID-19
pandemic on Bellicum’s clinical trial sites and trial enrollment,
other factors, such as safety issues, may impact Bellicum’s
clinical progress, actual expenses incurred may be higher than
anticipated, and trial results may be different than anticipated,
as discussed in greater detail under the heading “Risk Factors” in
Bellicum’s filings with the Securities and Exchange Commission,
including without limitation Bellicum’s annual report on Form 10-K
the year ended December 31, 2021 and in Bellicum’s subsequent
filings with the SEC. 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 Bellicum’s
forward-looking statements whether as a result of new information,
future events or otherwise, after the date of this press
release.
Source: Bellicum Pharmaceuticals
Investors:Robert H. UhlManaging DirectorICR Westwicke
858-356-5932Robert.uhl@westwicke.com
BELLICUM PHARMACEUTICALS, INC. |
|
|
|
Consolidated Balance Sheets |
|
|
|
(Unaudited; in thousands) |
|
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
Current
Assets: |
|
|
|
Cash and
cash equivalents |
$ |
46,156 |
|
|
$ |
35,495 |
|
Restricted
cash |
|
1,501 |
|
|
|
1,501 |
|
Accounts
receivable, interest and other receivables |
|
205 |
|
|
|
2 |
|
Prepaid
expenses and other current assets |
|
1,269 |
|
|
|
802 |
|
Assets held
for sale |
|
- |
|
|
|
1,643 |
|
|
|
|
|
Non-Current
Assets: |
|
|
|
Operating
lease right-of-use assets |
|
- |
|
|
|
645 |
|
Property and
equipment, net |
|
12 |
|
|
|
189 |
|
Other
assets |
|
- |
|
|
|
307 |
|
Total assets |
$ |
49,143 |
|
|
$ |
40,584 |
|
|
|
|
|
Current
Liabilities: |
|
|
|
Accounts
payable |
$ |
90 |
|
|
$ |
891 |
|
Accrued
expenses and other current liabilities |
|
3,849 |
|
|
|
4,165 |
|
Warrant
derivative liability |
|
2,773 |
|
|
|
10,345 |
|
Private
placement option liability |
|
- |
|
|
|
7,803 |
|
Current
portion of lease liabilities |
|
- |
|
|
|
825 |
|
Liabilities
held for sale |
|
- |
|
|
|
672 |
|
|
|
|
|
Long-Term
Liabilities: |
|
|
|
Long-term
lease liabilities |
|
- |
|
|
|
344 |
|
|
|
|
|
Preferred
stock |
|
18,036 |
|
|
|
18,036 |
|
Total
stockholders' equity (deficit) |
|
24,395 |
|
|
|
(2,497 |
) |
Total liabilities, preferred stock and stockholders' equity
(deficit) |
$ |
49,143 |
|
|
$ |
40,584 |
|
|
|
|
|
BELLICUM PHARMACEUTICALS, INC. |
|
|
|
|
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|
Consolidated Statements of Operations |
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|
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|
(Unaudited; in thousands, except share and per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months
ended |
|
Year
ended |
|
December
31 |
|
December
31 |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
Revenues: |
|
|
|
|
|
|
|
Supply agreement |
$ |
- |
|
|
$ |
- |
|
|
$ |
700 |
|
|
$ |
- |
|
License revenue |
|
500 |
|
|
|
500 |
|
|
|
5,500 |
|
|
|
500 |
|
Total
revenues |
|
500 |
|
|
|
500 |
|
|
|
6,200 |
|
|
|
500 |
|
|
|
|
|
|
|
|
|
Operating
Expenses: |
|
|
|
|
|
|
|
Research and development |
|
4,047 |
|
|
|
8,706 |
|
|
|
23,578 |
|
|
|
39,052 |
|
General and administrative |
|
1,551 |
|
|
|
3,436 |
|
|
|
7,010 |
|
|
|
15,531 |
|
Total
operating expenses |
|
5,598 |
|
|
|
12,142 |
|
|
|
30,588 |
|
|
|
54,583 |
|
Impairment of property and equipment |
|
- |
|
|
|
(1,265 |
) |
|
|
- |
|
|
|
(1,265 |
) |
Gain (loss) on dispositions, net |
|
- |
|
|
|
(105 |
) |
|
|
(478 |
) |
|
|
3,656 |
|
Loss from
operations |
|
(5,098 |
) |
|
|
(13,012 |
) |
|
|
(24,866 |
) |
|
|
(51,692 |
) |
|
|
|
|
|
|
|
|
Interest income |
|
- |
|
|
|
- |
|
|
|
32 |
|
|
|
387 |
|
Interest expense |
|
- |
|
|
|
(191 |
) |
|
|
(4 |
) |
|
|
(2,659 |
) |
Change in fair value of warrant and private placement option
liabilities |
|
7,619 |
|
|
|
31,874 |
|
|
|
15,126 |
|
|
|
46,130 |
|
Gain on extinguishment of debt |
|
- |
|
|
|
112 |
|
|
|
- |
|
|
|
112 |
|
Other income (expense) |
|
10 |
|
|
|
- |
|
|
|
7 |
|
|
|
- |
|
Net income
(loss) |
$ |
2,531 |
|
|
$ |
18,783 |
|
|
$ |
(9,705 |
) |
|
$ |
(7,722 |
) |
Less: undistributed earnings to participating securities |
|
(716 |
) |
|
|
(10,984 |
) |
|
|
- |
|
|
|
- |
|
Net income
(loss) attributable to common shareholders |
$ |
1,815 |
|
|
$ |
7,799 |
|
|
$ |
(9,705 |
) |
|
$ |
(7,722 |
) |
|
|
|
|
|
|
|
|
Net income
(loss) per common share attributable to common shareholders,
basic |
$ |
0.12 |
|
|
$ |
0.99 |
|
|
$ |
(0.84 |
) |
|
$ |
(1.34 |
) |
|
|
|
|
|
|
|
|
Net income
(loss) per common share attributable to common shareholders,
diluted |
$ |
0.11 |
|
|
$ |
0.98 |
|
|
$ |
(0.84 |
) |
|
$ |
(1.34 |
) |
|
|
|
|
|
|
|
|
Weighted-average shares outstanding, basic |
|
15,712,196 |
|
|
|
7,873,402 |
|
|
|
11,504,294 |
|
|
|
5,760,159 |
|
|
|
|
|
|
|
|
|
Weighted-average shares outstanding, diluted |
|
15,817,832 |
|
|
|
7,935,532 |
|
|
|
11,504,294 |
|
|
|
5,760,159 |
|
|
|
|
|
|
|
|
|
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