Bolt Biotherapeutics Reports First Quarter 2024 Results, Announces Strategic Pipeline Prioritization and Changes to Leadership Team
May 14 2024 - 4:05PM
Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage
biopharmaceutical company developing novel immunotherapies for the
treatment of cancer, today reported financial results for the first
quarter ended March 31, 2024 and announced a strategic
prioritization as well as changes to its leadership team. The
company will focus its pipeline on its first-in-class proprietary
agonist antibody targeting Dectin-2 and its next-generation
Boltbody™ ISAC programs, continue to support its
collaborations with Genmab and Toray, and reduce its workforce by
approximately 50%. This will extend cash runway into the second
half of 2026.
As part of this refocusing, Willie Quinn has been appointed
Chief Executive Officer. Grant Yonehiro has been promoted to Chief
Operating Officer, Dawn Colburn, Pharm.D. has been promoted to
Senior Vice President, Clinical Development. Michael Alonso, Ph.D.
has been promoted to Senior Vice President, Research and Sarah
Nemec is being appointed Principal Accounting Officer.
“At Bolt, we set a high bar for advancing our programs, and
while BDC-1001 provided clinical validation for the ISAC mechanism,
it did not meet our high bar for advancement. With limited
resources, we want to focus those resources on the best product
candidates. Our Boltbody™ ISAC technology platform continues
to improve and our next-gen ISACs have outperformed cytotoxic ADCs
in our preclinical studies. The increased activity of the next-gen
Boltbody™ ISACs is opening the door to tumor targets with
lower expression, while maintaining design choices that prioritize
safety. With this in mind, we have decided to discontinue all
BDC-1001 development and focus resources on BDC-3042 and BDC-4182,
our next-gen ISAC targeting the clinically validated cancer antigen
Claudin 18.2,” said Willie Quinn, Chief Executive Officer. “We
believe that BDC-3042, a first-in-class agonist antibody that
reawakens myeloid cells to attack tumor cells, has broad potential
across many tumor types. We’ve seen encouraging safety to date in
our Phase 1 dose escalation study of BDC-3042 and are excited about
the very strong preclinical data for BDC-4182. We believe focusing
on these programs will deliver significant value to shareholders.
In conjunction, we are streamlining our operations to align
resources and extend our cash runway to support these programs
through key value inflection points.”
“Over the last several years, Bolt has leveraged our expertise
to create Boltbody™ ISACs with optimized tumor-targeting
antibodies and stronger payloads that have the potential to deliver
superior efficacy while maintaining an acceptable safety profile,”
said Michael Alonso, Senior Vice President, Research. “We are
excited to advance our first next-generation Boltbody™ ISAC,
BDC-4182, as Bolt’s next clinical candidate and to unveil Claudin
18.2 as the target antigen for this agent. BDC-4182 has advanced
into IND-enabling studies and we look forward to sharing more
details soon.”
Recent Highlights and Anticipated
Milestones
- BDC-3042 Phase 1 dose escalation continues to
advance. BDC-3042, a proprietary agonist antibody that
targets Dectin-2, an immune activating receptor expressed by
tumor-associated macrophages (TAMs), has advanced through the first
3 dose escalation cohorts of the Phase 1 trial without any
dose-limiting toxicities, and the fourth dose level cohort is fully
enrolled. BDC-3042 has been well tolerated in each of the cohorts
to date. Bolt anticipates providing an update on enrollment and
safety in the second half of the year.
-
Announced BDC-4182 as Bolt’s next-generation
Boltbody™ ISAC clinical candidate
targeting Claudin 18.2. Claudin 18.2 is a novel,
clinically validated target in oncology with programs in
development for the treatment of gastric/gastroesophageal junction
cancer, pancreatic cancer, and other tumor types. BDC-4182 has
advanced into IND-enabling activities, supported by in vitro and in
vivo experiments demonstrating potent anti-tumor activity in
multiple preclinical models, some of which were presented at the
Society for Immunotherapy of Cancer’s (SITC) 2023 Annual Meeting in
October.
Corporate Updates
-
Discontinued development of trastuzumab imbotolimod
(BDC-1001). Following a strategic review, Bolt has
determined that the program will not meet its pre-defined success
criteria, and Bolt will therefore be focusing resources on its
next-generation ISAC programs.
-
Leadership changes. Willie Quinn is being
appointed Chief Executive Officer. Former officers Randall
Schatzman, Ph.D. and Edith Perez, M.D. are moving into advisory
roles with Bolt. Grant Yonehiro, currently Chief Business Officer,
is being promoted to Chief Operating Officer. Sarah Nemec, Vice
President Finance, is being appointed Principal Accounting Officer
and Michael Alonso, Ph.D., a co-founder of the company, is being
promoted to Senior Vice President, Research. Dawn Colburn, Pharm.D.
is being promoted to Senior Vice President of Clinical Development.
Dr. Colburn joined Bolt in 2023, bringing over two decades of
experience in oncology clinical development. Prior to joining Bolt,
she was Vice President of Clinical Science for Agenus and Arcus
Biosciences, where she built and led the clinical science
organization and the non-small cell lung cancer clinical
development strategy at both organizations.
-
Workforce reduction. In conjunction with this
strategic refocusing, the Company will be reducing its workforce by
approximately 50%. As a result of these actions, Bolt expects to
extend its cash runway into the second half 2026, funding the
completion of the BDC-3042 Phase 1 trial and also enabling the
delivery of clinical data for next-generation ISAC BDC-4182.
Mr. Quinn commented, “We sincerely thank our dedicated and
talented employees, as well as the BDC-1001 investigators and
patients, for all they’ve done to advance our mission to leverage
the immune system for a better way to treat cancer. To our
colleagues who will be leaving Bolt as part of this realignment, we
wish you all the best in your future endeavors and thank you for
your contributions in leading Bolt to where we are today."
First Quarter 2024 Financial Results
- Collaboration Revenue – Collaboration revenue
was $5.3 million and $1.8 million for the quarter ended March 31,
2024, and 2023, respectively. The increase in revenue for the
comparative periods was due to increased activity in collaborations
with Genmab and Toray Industries, Inc. as the Company fulfills its
performance obligations, and the conclusion of its performance
obligations for the Innovent collaboration. Bolt also recognized
$4.7 million in Other Income as a result of concluding its
collaboration with Innovent.
- Research and Development (R&D) Expenses –
R&D expenses were $16.5 million for the quarter ended March 31,
2024, compared to $14.6 million for the same quarter in 2023. The
increase in R&D expenses was due to higher clinical trial
expenses due to continued progress in our clinical trials for
product candidates, higher research and development contract
service expenses, and higher salary and related expenses, partially
offset by lower manufacturing expenses related to timing of batch
production of our product candidates.
- General and Administrative (G&A) Expenses
– G&A expenses were $5.8 million for the quarter ended
March 31, 2024, compared to $5.6 million for the same quarter in
2023. The increase in G&A expenses was due to higher salary and
related expenses and higher consulting and professional services
expenses.
- Loss from Operations – Loss from operations
was $17.1 million for the quarter ended March 31, 2024, compared to
$18.4 million for the same quarter in 2023.
Conference Call and Webcast DetailsBolt will
host a conference call and webcast today, May 14, 2024, at 4:30
p.m. Eastern Time to discuss its strategic restructuring. The
webcast can be accessed by clicking the link:
https://edge.media-server.com/mmc/p/im7tcsw2, and will be available
on the “Events and Presentations” page in the “Investors” section
of the Company’s website. A replay of the webcast will be archived
on the Company’s website for up to 30 days following the
presentation. A more detailed presentation of the results will be
made available on the Company’s website at www.boltbio.com.
About the Boltbody™ Immune-Stimulating Antibody
Conjugate (ISAC) PlatformBolt 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 BDC-3042, a first-in-class agonist
antibody that activates macrophages by targeting Dectin-2, and
BDC-4182, a next-generation Boltbody™ Immune Stimulating Antibody
Conjugate (ISAC) clinical candidate targeting Claudin 18.2.
BDC-3042 is currently in a Phase 1 dose escalation trial that
includes patients with any of 6 different solid tumor types.
BDC-4182 is supported by strong in vitro and in vivo data
demonstrating potent anti-tumor activity, and activities are
underway to support the initiation of clinical trials in 2025. Bolt
Biotherapeutics is also developing additional 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 BDC-3042 clinical trial, the
initiation of future clinical trials, the potential value of
collaborations, and the duration of our cash runway, 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)
600-1902boltbio@argotpartners.com
BOLT BIOTHERAPEUTICS, INC.STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS(Unaudited, in thousands, except
share and per share amounts) |
|
|
Three Months Ended March 31, |
|
|
|
2024 |
|
2023 |
Collaboration revenue |
|
$ |
5,274 |
|
|
$ |
1,826 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
16,529 |
|
|
|
14,625 |
|
General and administrative |
|
|
5,837 |
|
|
|
5,616 |
|
Total
operating expense |
|
|
22,366 |
|
|
|
20,241 |
|
Loss
from operations |
|
|
(17,092 |
) |
|
|
(18,415 |
) |
Other
income, net |
|
|
|
|
|
|
Interest income, net |
|
|
1,606 |
|
|
|
1,435 |
|
Other income |
|
|
4,675 |
|
|
|
— |
|
Total
other income, net |
|
|
6,281 |
|
|
|
1,435 |
|
Net
loss |
|
|
(10,811 |
) |
|
|
(16,980 |
) |
Net unrealized (loss) gain on marketable securities |
|
|
(73 |
) |
|
|
684 |
|
Comprehensive loss |
|
$ |
(10,884 |
) |
|
$ |
(16,296 |
) |
Net loss
per share, basic and diluted |
|
$ |
(0.28 |
) |
|
$ |
(0.45 |
) |
Weighted-average shares outstanding, basic and diluted |
|
|
38,068,424 |
|
|
|
37,684,023 |
|
BOLT BIOTHERAPEUTICS, INC.BALANCE
SHEETS(Unaudited, in thousands) |
|
|
March 31, |
|
|
December 31, |
|
|
|
2024 |
|
|
2023 |
|
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
4,262 |
|
|
$ |
10,810 |
|
Short-term investments |
|
|
87,088 |
|
|
|
91,379 |
|
Prepaid expenses and other current assets |
|
|
3,705 |
|
|
|
3,519 |
|
Total
current assets |
|
|
95,055 |
|
|
|
105,708 |
|
Property
and equipment, net |
|
|
4,499 |
|
|
|
4,957 |
|
Operating lease right-of-use assets |
|
|
18,347 |
|
|
|
19,120 |
|
Restricted cash |
|
|
1,765 |
|
|
|
1,765 |
|
Long-term investments |
|
|
21,461 |
|
|
|
26,413 |
|
Other
assets |
|
|
1,765 |
|
|
|
1,821 |
|
Total
assets |
|
$ |
142,892 |
|
|
$ |
159,784 |
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
2,219 |
|
|
$ |
2,987 |
|
Accrued expenses and other current liabilities |
|
|
9,710 |
|
|
|
12,486 |
|
Deferred revenue |
|
|
1,907 |
|
|
|
2,201 |
|
Operating lease liabilities |
|
|
2,887 |
|
|
|
2,782 |
|
Total
current liabilities |
|
|
16,723 |
|
|
|
20,456 |
|
Operating lease liabilities, net of current portion |
|
|
16,680 |
|
|
|
17,437 |
|
Deferred
revenue, non-current |
|
|
5,330 |
|
|
|
9,107 |
|
Other
long-term liabilities |
|
|
- |
|
|
|
43 |
|
Total liabilities |
|
|
38,733 |
|
|
|
47,043 |
|
Commitments and contingencies |
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
Common
stock |
|
|
1 |
|
|
|
1 |
|
Additional paid-in capital |
|
|
479,290 |
|
|
|
476,988 |
|
Accumulated other comprehensive (loss) gain |
|
|
(36 |
) |
|
|
37 |
|
Accumulated deficit |
|
|
(375,096 |
) |
|
|
(364,285 |
) |
Total stockholders' equity: |
|
|
104,159 |
|
|
|
112,741 |
|
Total
liabilities and stockholders' equity |
|
$ |
142,892 |
|
|
$ |
159,784 |
|
|
|
|
|
|
|
|
BOLT BIOTHERAPEUTICS, INC.STATEMENTS OF CASH
FLOWS(Unaudited, in thousands) |
|
|
Three Months Ended March 31, |
|
|
|
2024 |
|
|
2023 |
|
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
Net loss |
|
$ |
(10,811 |
) |
|
$ |
(16,980 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
Depreciation and amortization |
|
|
458 |
|
|
|
467 |
|
Stock-based compensation expense |
|
|
2,302 |
|
|
|
2,476 |
|
Accretion of discount on marketable securities |
|
|
(1,033 |
) |
|
|
(852 |
) |
Non-cash lease expense |
|
|
773 |
|
|
|
719 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
Prepaid expenses and other assets |
|
|
(130 |
) |
|
|
(1,377 |
) |
Accounts payable and accrued expenses |
|
|
(3,544 |
) |
|
|
(6,611 |
) |
Operating lease liabilities |
|
|
(652 |
) |
|
|
(559 |
) |
Deferred revenue |
|
|
(4,071 |
) |
|
|
(683 |
) |
Other long-term liabilities |
|
|
(43 |
) |
|
|
1 |
|
Net cash
used in operating activities |
|
|
(16,751 |
) |
|
|
(23,399 |
) |
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
Purchase
of property and equipment |
|
|
— |
|
|
|
(3 |
) |
Purchases of marketable securities |
|
|
(23,058 |
) |
|
|
(42,883 |
) |
Maturities of marketable securities |
|
|
33,261 |
|
|
|
71,877 |
|
Net cash
provided by investing activities |
|
|
10,203 |
|
|
|
28,991 |
|
Net
(decrease) increase in cash |
|
|
(6,548 |
) |
|
|
5,592 |
|
Cash,
cash equivalents and restricted cash at beginning of year |
|
|
12,575 |
|
|
|
10,809 |
|
Cash,
cash equivalents and restricted cash at end of period |
|
$ |
6,027 |
|
|
$ |
16,401 |
|
Reconciliation of cash, cash equivalents and restricted
cash: |
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
4,262 |
|
|
$ |
14,836 |
|
Restricted cash |
|
|
1,765 |
|
|
|
1,565 |
|
Total cash, cash equivalents and restricted cash |
|
$ |
6,027 |
|
|
$ |
16,401 |
|
Supplemental schedule of non-cash investing and financing
activities: |
|
|
|
|
|
|
Purchases of property and equipment included in accounts payable
and accrued liabilities |
|
$ |
— |
|
|
$ |
46 |
|
Deferred
offering costs in accounts payable and accrued liabilities |
|
$ |
102 |
|
|
$ |
102 |
|
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