Bolt Biotherapeutics Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Business Update
21 Março 2024 - 5:05PM
Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage
biopharmaceutical company developing novel immunotherapies for the
treatment of cancer, today reported financial results for the
fourth quarter and full year ended December 31, 2023, and provided
a business update.
“We made substantial progress advancing our two proprietary
clinical-stage development programs in 2023,” said Randall
Schatzman, Ph.D., Chief Executive Officer. “We have now
administered BDC-1001, which we have renamed trastuzumab
imbotolimod, to patients in all five of the Phase 2 cohorts.
BDC-3042 also continues to advance, and has now entered the fourth
dose escalation cohort without a dose-limiting toxicity. Both
clinical programs are on track and we look forward to providing
updates later this year.”
Recent Highlights and Anticipated
Milestones
- Trastuzumab imbotolimod (BDC-1001) Phase 2 program
continues to advance. Trastuzumab imbotolimod is a
Boltbody™ ISAC that is currently in Phase 2 clinical development
across five distinct cohorts treating patients with HER2-positive
cancer. The first three cohorts evaluate monotherapy trastuzumab
imbotolimod in colorectal, endometrial, and gastroesophageal
cancer, and the fourth and fifth cohorts evaluate trastuzumab
imbotolimod with or without pertuzumab for the treatment of HER-2
positive metastatic breast cancer. All cohorts utilize a Simon
two-stage design. Roche is providing pertuzumab in support of the
trial. The most recent update on trastuzumab imbotolimod was
presented at the ESMO 2023 Congress in October 2023, noting a 29%
objective response rate (ORR) comprising 1 complete response (CR)
and 3 partial responses (PRs) in evaluable patients with
HER2-positive tumors at the recommended Phase 2 dose (RP2D).
BDC-1001 was well tolerated. The most common treatment-related
treatment-emergent adverse events (TEAE) was Grade 1 or 2
infusion-related reactions, which were seen in 30% of patients in
the study.
- BDC-3042 Phase 1 dose escalation study continues to
advance. BDC-3042 is a proprietary agonist antibody that
targets Dectin-2, an immune-activating receptor expressed by
tumor-associated macrophages (TAMs). This dose-escalation Phase 1
clinical study will initially evaluate BDC-3042 as monotherapy in
patients with a variety of solid tumors, and will then evaluate the
combination of BDC-3042 with a PD-1 inhibitor. Bolt has completed
the first three dosing cohorts without observing any dose-limiting
toxicities and the trial is enrolling well.
- Cash, cash equivalents, and marketable securities were
$128.6 million as of December 31, 2023. Cash on hand is
expected to fund multiple clinical milestones in 2024 and
operations through late 2025.
Fourth Quarter and Full Year 2023 Financial
Results
- Collaboration Revenue – Collaboration revenue
was $2.1 million for the quarter and $7.9 million for the full year
ended December 31, 2023, compared to $1.4 million and $5.7 million
for the same quarter and year in 2022. Revenue in the comparative
periods was generated from the services performed under our R&D
collaborations as we fulfill our performance
obligations.
- Research and Development (R&D) Expenses –
R&D expenses were $16.3 million for the quarter and $61.5
million for the full year ended December 31, 2023, compared to
$16.8 million and $73.1 million for the same quarter and year ended
2022. The decrease in R&D expenses was due to lower
manufacturing expenses related to the timing of batch production,
offset by higher clinical expenses related to the advancement of
trastuzumab imbotolimod clinical trial into Phase 2.
- General and Administrative (G&A) Expenses
– G&A expenses were $5.5 million for the quarter and
$22.5 million for the full year ended December 31, 2023, compared
to $5.6 million and $22.9 million for the same quarter and year in
2022.
- Loss from Operations – Loss from operations
was $19.8 million for the quarter and $76.2 million for the full
year ended December 31, 2023, compared to $21.0 million and $90.3
million for the same quarter and year in 2022. This is in part a
reflection of proactive cost-containment measures taken in June
2022.
About the Boltbody™ Immune-Stimulating Antibody
Conjugate (ISAC) Platform Bolt Biotherapeutics’ Boltbody
ISAC platform harnesses the precision of antibodies with the power
of the innate and adaptive immune system to reprogram the tumor
microenvironment to generate a productive anti-cancer response.
Each Boltbody ISAC candidate comprises a tumor-targeting antibody,
a non-cleavable linker, and a proprietary immune stimulant. The
antibody is designed to target one or more markers on the surface
of a tumor cell and the immune stimulant is designed to recruit and
activate myeloid cells. Activated myeloid cells initiate a positive
feedback loop by releasing cytokines and chemokines, chemical
signals that attract other immune cells and lower the activation
threshold for an immune response. This increases the population of
activated immune system cells in the tumor microenvironment and
promotes a robust immune response with the goal of generating
durable therapeutic responses for patients with cancer.
About Bolt Biotherapeutics, Inc. Bolt
Biotherapeutics is a clinical-stage biopharmaceutical company
developing novel immunotherapies for the treatment of cancer. Bolt
Biotherapeutics’ pipeline candidates are built on the Company’s
deep expertise in myeloid biology and cancer drug development. The
Company’s pipeline includes trastuzumab imbotolimod (formerly
BDC-1001), a HER2-targeting Boltbody™ Immune-Stimulating Antibody
Conjugate (ISAC), BDC-3042, a myeloid-modulating antibody, and
multiple Boltbody ISAC collaboration programs. Trastuzumab
imbotolimod is currently in Phase 2 clinical development following
the successful completion of a Phase 1 dose-escalation trial that
demonstrated tolerability and early clinical efficacy. BDC-3042, an
agonist antibody targeting Dectin-2, is currently in a Phase 1
dose-escalation trial. In preclinical development, BDC-3042
demonstrated the ability to convert tumor-supportive macrophages to
tumor-destructive macrophages. Bolt Biotherapeutics is also
developing multiple Boltbody™ ISACs in strategic collaborations
with leading biopharmaceutical companies. For more information,
please visit https://www.boltbio.com/
Forward-Looking StatementsThis press release
contains forward-looking statements about us and our industry that
involve substantial risks and uncertainties and are based on our
beliefs and assumptions and on information currently available to
us. All statements other than statements of historical facts
contained in this press release, including statements regarding the
advancement and success of our clinical trials, the timing of
future updates from our clinical programs, the potential profile of
BDC-1001 and BDC-3042, the potential benefits of combining
BDC-1001 with pertuzumab, and our expectation that our cash on hand
will fund multiple milestones and operations through late 2025, are
forward-looking statements. In some cases, you can identify
forward-looking statements because they contain words such as
“anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,”
“may,” “on track,” “plan,” “potential,” “predict,” “project,”
“should,” “will,” or “would,” or the negative of these words or
other similar terms or expressions. Forward-looking statements
involve known and unknown risks, uncertainties and other factors
that may cause our actual results, performance, or achievements to
be materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements. Forward-looking statements represent our current
beliefs, estimates and assumptions only as of the date of this
press release and information contained in this press release
should not be relied upon as representing our estimates as of any
subsequent date. These statements, and related risks,
uncertainties, factors and assumptions, include, but are not
limited to: the potential product candidates that we develop may
not progress through clinical development or receive required
regulatory approvals within expected timelines or at all; clinical
trials may not confirm any safety, potency or other product
characteristics described or assumed in this press release; such
product candidates may not be beneficial to patients or become
commercialized; and our ability to maintain our current
collaborations and establish further collaborations. These risks
are not exhaustive. Except as required by law, we assume no
obligation to update these forward-looking statements, or to update
the reasons actual results could differ materially from those
anticipated in the forward-looking statements, even if new
information becomes available in the future. Further information on
factors that could cause actual results to differ materially from
the results anticipated by our forward-looking statements is
included in the reports we have filed or will file with the
Securities and Exchange Commission, including our Annual Report on
Form 10-K for the year ended December 31, 2023. These filings, when
available, are available on the investor relations section of our
website at investors.boltbio.com and on the SEC’s website at
www.sec.gov.
Investor Relations and Media
Contact: Matthew DeYoung Argot
Partners (212) 600-1902 boltbio@argotpartners.com
BOLT BIOTHERAPEUTICS, INC.STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS(In thousands,
except share and per share amounts) |
|
|
|
|
|
For The Three Months Ended December 31, |
|
|
Years Ended December 31, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Collaboration revenue |
|
$ |
2,089 |
|
|
$ |
1,411 |
|
|
$ |
7,876 |
|
|
$ |
5,729 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
16,322 |
|
|
|
16,845 |
|
|
|
61,542 |
|
|
|
73,123 |
|
General and administrative |
|
|
5,533 |
|
|
|
5,606 |
|
|
|
22,530 |
|
|
|
22,927 |
|
Total operating expense |
|
|
21,855 |
|
|
|
22,451 |
|
|
|
84,072 |
|
|
|
96,050 |
|
Loss from operations |
|
|
(19,766 |
) |
|
|
(21,040 |
) |
|
|
(76,196 |
) |
|
|
(90,321 |
) |
Other income, net |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
1,863 |
|
|
|
1,043 |
|
|
|
6,999 |
|
|
|
2,223 |
|
Total other income, net |
|
|
1,863 |
|
|
|
1,043 |
|
|
|
6,999 |
|
|
|
2,223 |
|
Net loss |
|
|
(17,903 |
) |
|
|
(19,997 |
) |
|
|
(69,197 |
) |
|
|
(88,098 |
) |
Net unrealized gain (loss) on
marketable securities |
|
|
211 |
|
|
|
790 |
|
|
|
956 |
|
|
|
(598 |
) |
Comprehensive loss |
|
$ |
(17,692 |
) |
|
$ |
(19,207 |
) |
|
$ |
(68,241 |
) |
|
$ |
(88,696 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.47 |
) |
|
$ |
(0.53 |
) |
|
$ |
(1.83 |
) |
|
$ |
(2.36 |
) |
Weighted-average shares
outstanding, basic and diluted |
|
|
37,941,587 |
|
|
|
37,552,208 |
|
|
|
37,811,984 |
|
|
|
37,358,425 |
|
BOLT BIOTHERAPEUTICS, INC.BALANCE
SHEETS(In thousands) |
|
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
10,810 |
|
|
$ |
9,244 |
|
Short-term investments |
|
|
91,379 |
|
|
|
159,644 |
|
Prepaid expenses and other current assets |
|
|
3,519 |
|
|
|
3,858 |
|
Total current assets |
|
|
105,708 |
|
|
|
172,746 |
|
Property and equipment, net |
|
|
4,957 |
|
|
|
6,453 |
|
Operating lease right-of-use
assets |
|
|
19,120 |
|
|
|
22,072 |
|
Restricted cash |
|
|
1,765 |
|
|
|
1,565 |
|
Long-term investments |
|
|
26,413 |
|
|
|
23,943 |
|
Other assets |
|
|
1,821 |
|
|
|
1,028 |
|
Total assets |
|
$ |
159,784 |
|
|
$ |
227,807 |
|
|
|
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,987 |
|
|
$ |
3,594 |
|
Accrued expenses and other current liabilities |
|
|
12,486 |
|
|
|
15,140 |
|
Deferred revenue |
|
|
2,201 |
|
|
|
1,993 |
|
Operating lease liabilities |
|
|
2,782 |
|
|
|
2,391 |
|
Total current liabilities |
|
|
20,456 |
|
|
|
23,118 |
|
Operating lease liabilities, net
of current portion |
|
|
17,437 |
|
|
|
20,220 |
|
Deferred revenue,
non-current |
|
|
9,107 |
|
|
|
12,921 |
|
Other long-term liabilities |
|
|
43 |
|
|
|
42 |
|
Total liabilities |
|
|
47,043 |
|
|
|
56,301 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Stockholders'
equity: |
|
|
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
1 |
|
|
|
— |
|
Additional paid-in capital |
|
|
476,988 |
|
|
|
467,513 |
|
Accumulated other comprehensive
gain (loss) |
|
|
37 |
|
|
|
(919 |
) |
Accumulated deficit |
|
|
(364,285 |
) |
|
|
(295,088 |
) |
Total stockholders' equity |
|
|
112,741 |
|
|
|
171,506 |
|
Total liabilities, convertible
preferred stock, and stockholders' equity |
|
$ |
159,784 |
|
|
$ |
227,807 |
|
BOLT BIOTHERAPEUTICS, INC.STATEMENTS OF
CASH FLOWS(In thousands) |
|
|
|
Years Ended December 31, |
|
|
|
2023 |
|
|
2022 |
|
CASH FLOWS FROM OPERATING
ACTIVITIES: |
|
|
|
|
|
|
Net loss |
|
$ |
(69,197 |
) |
|
$ |
(88,098 |
) |
Adjustments to reconcile net loss
to net cash used |
|
|
|
|
|
|
in operating activities: |
|
|
|
|
|
|
Depreciation and amortization |
|
|
1,854 |
|
|
|
1,666 |
|
Stock-based compensation expense |
|
|
9,223 |
|
|
|
9,576 |
|
Accretion of premium/discount on short-term investments |
|
|
(4,493 |
) |
|
|
184 |
|
Non-cash lease expense |
|
|
2,952 |
|
|
|
3,225 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
Prepaid expenses and other assets |
|
|
(454 |
) |
|
|
(903 |
) |
Accounts payable and accrued expenses |
|
|
(3,413 |
) |
|
|
2,768 |
|
Operating lease liabilities |
|
|
(2,392 |
) |
|
|
(2,596 |
) |
Deferred revenue |
|
|
(3,606 |
) |
|
|
(2,162 |
) |
Other long-term liabilities |
|
|
1 |
|
|
|
(164 |
) |
Net cash used in operating activities |
|
|
(69,525 |
) |
|
|
(76,504 |
) |
CASH FLOWS FROM INVESTING
ACTIVITIES: |
|
|
|
|
|
|
Purchase of property and equipment |
|
|
(206 |
) |
|
|
(1,953 |
) |
Purchases of marketable securities |
|
|
(164,988 |
) |
|
|
(180,704 |
) |
Maturities of marketable securities |
|
|
236,232 |
|
|
|
240,519 |
|
Net cash provided by investing activities |
|
|
71,038 |
|
|
|
57,862 |
|
CASH FLOWS FROM FINANCING
ACTIVITIES: |
|
|
|
|
|
|
Proceeds from issuance of common stock |
|
|
253 |
|
|
|
503 |
|
Net cash provided by financing activities |
|
|
253 |
|
|
|
503 |
|
NET INCREASE (DECREASE) IN CASH |
|
|
1,766 |
|
|
|
(18,139 |
) |
Cash, cash equivalents and
restricted cash at beginning of year |
|
|
10,809 |
|
|
|
28,948 |
|
Cash, cash equivalents and
restricted cash at end of period |
|
$ |
12,575 |
|
|
$ |
10,809 |
|
Reconciliation of cash,
cash equivalents and restricted cash: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
10,810 |
|
|
$ |
9,244 |
|
Restricted cash |
|
|
1,765 |
|
|
|
1,565 |
|
Total cash, cash equivalents and
restricted cash |
|
$ |
12,575 |
|
|
$ |
10,809 |
|
Supplemental schedule of
non-cash investing and financing activities: |
|
|
|
|
|
|
Purchases of property and
equipment included in accounts payable and accrued liabilities |
|
$ |
152 |
|
|
$ |
8 |
|
Deferred offering costs in
accounts payable and accrued liabilities |
|
$ |
102 |
|
|
$ |
102 |
|
Right of use assets obtained in
exchange for operating lease obligations |
|
$ |
— |
|
|
$ |
852 |
|
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