Bolt Biotherapeutics, Inc. (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, 2023 and provided a business update.
“We are pleased to be advancing our lead Boltbody™ ISAC,
BDC-1001, into a broader Phase 2 program in four different
HER2-positive solid tumor types, following the recent positive
topline results from our Phase 1 dose-escalation trial. We are
looking forward to presenting a comprehensive dataset at ASCO from
this first-in-human study, in which BDC-1001 achieved target drug
exposure levels, was well tolerated from a safety perspective and
demonstrated objective clinical responses and long-term durability
both as a single agent and in combination with nivolumab,” said
Randall Schatzman, Ph.D., Chief Executive Officer of Bolt
Biotherapeutics. “As we prepare for Phase 2 studies in the U.S. and
internationally, we look forward to investigating the benefits of
BDC-1001 and our novel ISAC mechanism to aid HER2-positive cancer
patients who are not benefitting from current therapeutic options.
Additionally, the Bolt team is excited to be advancing our next
program, BDC-3042, a proprietary Dectin-2 agonist antibody, into
the clinic later this year.”
Recent Highlights and Anticipated
Milestones
- Topline BDC-1001 Phase 1
dose-escalation clinical data unveiled from a
multi-center, multi-dose clinical trial in more than 100 patients.
The data demonstrated BDC-1001 was well-tolerated at all dose
levels and schedules. BDC-1001 achieved objective clinical
responses as a monotherapy and in combination with the PD-1
inhibitor nivolumab across a diverse range of solid tumor types.
Target drug exposure levels were achieved at or near the
recommended Phase 2 dose (RP2D) by more frequent administration
including every other week (q2w) and weekly (q1w) administration
schedules.
Comprehensive first-in-human
safety and efficacy data will be presented by Bob Li, M.D.,
Ph.D., MPH, medical oncologist, and
principal investigator at Memorial Sloan Kettering Cancer Center
(MSK) in a poster presentation at the upcoming 2023 American
Society of Clinical Oncology Annual Meeting (ASCO 2023) on
Saturday, June 3 in Chicago, Illinois.
- Phase 2 BDC-1001 studies in
four HER2+ solid tumor types are planned to initiate in
2023 with trials conducted at clinical sites in the U.S.,
Europe, and South Korea. Phase 2 dose expansions will investigate
BDC-1001 as a monotherapy in three separate cohorts of patients
with colorectal, endometrial, and gastroesophageal cancer. A
separate combination arm with nivolumab is expected to initiate
following demonstration of monotherapy anti-tumor activity in each
of the three tumor types. An additional study, a randomized two-arm
Phase 2 clinical trial, will investigate BDC-1001 as monotherapy
and in combination with pertuzumab in patients with HER2-positive
metastatic breast cancer whose disease has progressed following
treatment with Enhertu®.
Under a new supply agreement
with Roche announced in the first quarter of 2023, Roche
will provide pertuzumab for the Phase 2 breast cancer study. Under
a previously announced agreement, BMS will provide nivolumab for
the Phase 2 expansion studies.
- New BDC-3042 data presented at
the 2023 American Association of Cancer Research (AACR) Annual
Meeting in April 2023 in Orlando, Florida. BDC-3042 is an
agonist antibody targeting Dectin-2, an immune-activating receptor
expressed by tumor-associated macrophages (TAMs) in solid tumors.
These preclinical data highlight recent findings on key
characteristics of BDC-3042 in reprogramming Dectin-2-expressing
TAMs, leading to the production of an array of pro-inflammatory
cytokines and chemokines associated with anti-tumor immunity, and
tumor growth inhibition in humanized mouse models of cancer, alone
and in combination with a PD-1 checkpoint inhibitor.
BDC-3042 to enter the clinic
in 2023 following completion of Investigational New Drug
(IND)-enabling activities, and clearance of a U.S. IND to initiate
first-in-human studies later in 2023.
- Boltbody™ ISAC collaborations
with Genmab and Innovent to develop next-generation Boltbody ISACs
continue to make progress. These collaborations are
exploring proprietary linker-payloads from the Boltbody ISAC
platform in combination with Genmab’s proprietary bispecific
antibodies and with Innovent’s proprietary antibodies,
respectively.
- Cash, cash equivalents, and
marketable securities were $171.0 million as of March 31,
2023. Cash on hand, coupled with collaboration revenues, is
expected to fund clinical milestones and operations through
2025.
Upcoming Events
- BDC-1001 poster presentation at
the 2023 American Society of Clinical Oncology (ASCO) Annual
Meeting in Chicago, Ill.
Title: A phase 1/2
study of a first-in-human immune-stimulating antibody conjugate
(ISAC) BDC-1001 in patients with advanced HER2-expressing solid
tumorsAbstract ID: 2538Abstract
Category: Developmental Therapeutics—Immunotherapy
Presenter: Dr. Bob
Li, medical oncologist, and principal investigator at MSK
Poster Session: Developmental
Therapeutics—ImmunotherapyDetails: Saturday, June
3, 2023, 8:00 - 11:00 a.m. CDTLocation: McCormick
Place Convention Center, Chicago, Illinois
First Quarter 2023 Financial Results
- Collaboration Revenue – Collaboration revenue
was $1.8 million and $0.8 million for the quarter ended March 31,
2023, and 2022, respectively. The increase in revenue for the
comparative periods was due to increased activity in our
collaborations with Genmab and Innovent as we fulfill our
performance obligations.
- Research and Development (R&D) Expenses –
R&D expenses were $14.6 million for the quarter ended March 31,
2023, compared to $18.4 million for the same quarter in 2022. The
decrease in R&D expenses was due to lower manufacturing
expenses related to the timing of batch production of our product
candidates and lower contract service expenses as well as our
pipeline reprioritization in June of 2022, offset by higher
clinical expenses related to the ongoing BDC-1001 clinical
trial.
- General and Administrative (G&A) Expenses
– G&A expenses were $5.6 million for the quarter ended
March 31, 2023, compared to $6.3 million for the same quarter in
2022. The decrease in G&A expenses was due to lower consulting
and professional services expenses.
- Loss from Operations – Loss from operations
was $18.4 million for the quarter ended March 31, 2023, compared to
$23.9 million for the same quarter in 2022.
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 that attract
other immune cells and lower the activation threshold for an immune
response. This process increases the number of activated immune
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-1001, a HER2-targeting Boltbody
Immune-Stimulating Antibody Conjugate (ISAC), BDC-3042, a myeloid
cell-modulating antibody, and multiple Boltbody ISAC collaboration
programs. BDC-1001 has completed a Phase 1 dose-escalation study
demonstrating tolerability and early clinical efficacy, and the
Company plans to initiate Phase 2 studies in 2023. Bolt
Biotherapeutics is advancing BDC-3042, an agonist antibody
targeting Dectin-2, through IND-enabling activities and expects to
initiate a Phase 1 trial in the second half of 2023. In preclinical
development, BDC-3042 demonstrated the ability to convert
tumor-supportive macrophages to tumor-destructive macrophages. Bolt
Biotherapeutics is pursuing novel applications of its technologies
to develop multiple immuno-oncology candidates through 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
poster presentation at ASCO 2023, the advancement and success of
our clinical trials, the expansion of our clinical trials across
Europe and South Korea, the success of our collaborations and the
ability of our clinical collaboration partners to supply nivolumab
and pertuzumab, our ability to fund our clinical programs, the
sufficiency of our cash, cash equivalents, and marketable
securities, and our future results of operations, financial
condition, business strategy and plans 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,
2022. 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.
BOLT BIOTHERAPEUTICS, INC.CONDENSED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS(Unaudited, in thousands, except share and per
share amounts) |
|
|
|
Three Months Ended March 31, |
|
|
|
2023 |
|
2022 |
Collaboration revenue |
|
$ |
1,826 |
|
|
$ |
813 |
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
14,625 |
|
|
|
18,385 |
|
General and administrative |
|
|
5,616 |
|
|
|
6,304 |
|
Total operating expense |
|
|
20,241 |
|
|
|
24,689 |
|
Loss from operations |
|
|
(18,415 |
) |
|
|
(23,876 |
) |
Other income, net |
|
|
|
|
|
|
Interest income, net |
|
|
1,435 |
|
|
|
198 |
|
Total other income, net |
|
|
1,435 |
|
|
|
198 |
|
Net loss |
|
|
(16,980 |
) |
|
|
(23,678 |
) |
Net unrealized gain (loss) on marketable securities |
|
|
684 |
|
|
|
(1,075 |
) |
Comprehensive loss |
|
$ |
(16,296 |
) |
|
$ |
(24,753 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.45 |
) |
|
$ |
(0.64 |
) |
Weighted-average shares
outstanding, basic and diluted |
|
|
37,684,023 |
|
|
|
37,127,876 |
|
|
BOLT BIOTHERAPEUTICS, INC.CONDENSED
BALANCE SHEETS(Unaudited, in
thousands) |
|
|
|
March 31, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
14,836 |
|
|
$ |
9,244 |
|
Short-term investments |
|
|
111,543 |
|
|
|
159,644 |
|
Prepaid expenses and other current assets |
|
|
5,230 |
|
|
|
3,858 |
|
Total current assets |
|
|
131,609 |
|
|
|
172,746 |
|
Property and equipment,
net |
|
|
6,035 |
|
|
|
6,453 |
|
Operating lease right-of-use
assets |
|
|
21,353 |
|
|
|
22,072 |
|
Restricted cash |
|
|
1,565 |
|
|
|
1,565 |
|
Long-term investments |
|
|
44,586 |
|
|
|
23,943 |
|
Other assets |
|
|
1,033 |
|
|
|
1,028 |
|
Total assets |
|
$ |
206,181 |
|
|
$ |
227,807 |
|
Liabilities and
stockholders' equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
1,835 |
|
|
$ |
3,594 |
|
Accrued expenses and other current liabilities |
|
|
10,334 |
|
|
|
15,140 |
|
Deferred revenue |
|
|
1,600 |
|
|
|
1,993 |
|
Operating lease liabilities |
|
|
2,484 |
|
|
|
2,391 |
|
Total current liabilities |
|
|
16,253 |
|
|
|
23,118 |
|
Operating lease liabilities,
net of current portion |
|
|
19,568 |
|
|
|
20,220 |
|
Deferred revenue,
non-current |
|
|
12,631 |
|
|
|
12,921 |
|
Other long-term
liabilities |
|
|
43 |
|
|
|
42 |
|
Total liabilities |
|
|
48,495 |
|
|
|
56,301 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Stockholders'
equity: |
|
|
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
— |
|
|
|
— |
|
Additional paid-in
capital |
|
|
469,989 |
|
|
|
467,513 |
|
Accumulated other
comprehensive loss |
|
|
(235 |
) |
|
|
(919 |
) |
Accumulated deficit |
|
|
(312,068 |
) |
|
|
(295,088 |
) |
Total stockholders' equity: |
|
|
157,686 |
|
|
|
171,506 |
|
Total liabilities and
stockholders' equity |
|
$ |
206,181 |
|
|
$ |
227,807 |
|
|
|
|
|
|
|
|
BOLT BIOTHERAPEUTICS, INC.CONDENSED
STATEMENTS OF CASH FLOWS(Unaudited, in
thousands) |
|
|
|
Three Months Ended March 31, |
|
|
|
2023 |
|
2022 |
CASH FLOWS FROM
OPERATING ACTIVITIES: |
|
|
|
|
|
|
Net loss |
|
$ |
(16,980 |
) |
|
$ |
(23,678 |
) |
Adjustments to reconcile net
loss to net cash used in operating activities: |
|
|
|
|
|
|
Depreciation and amortization |
|
|
467 |
|
|
|
357 |
|
Stock-based compensation expense |
|
|
2,476 |
|
|
|
2,919 |
|
Accretion of premium/discount on marketable securities |
|
|
(852 |
) |
|
|
466 |
|
Non-cash lease expense |
|
|
719 |
|
|
|
1,171 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
Prepaid expenses and other assets |
|
|
(1,377 |
) |
|
|
(2,120 |
) |
Accounts payable and accrued expenses |
|
|
(6,611 |
) |
|
|
(2,392 |
) |
Operating lease liabilities |
|
|
(559 |
) |
|
|
(982 |
) |
Deferred revenue |
|
|
(683 |
) |
|
|
(51 |
) |
Other long-term liabilities |
|
|
1 |
|
|
|
(4 |
) |
Net cash used in operating
activities |
|
|
(23,399 |
) |
|
|
(24,314 |
) |
CASH FLOWS FROM
INVESTING ACTIVITIES: |
|
|
|
|
|
|
Purchase of property and
equipment |
|
|
(3 |
) |
|
|
(605 |
) |
Purchases of marketable
securities |
|
|
(42,883 |
) |
|
|
(76,084 |
) |
Maturities of marketable
securities |
|
|
71,877 |
|
|
|
117,534 |
|
Net cash provided by investing
activities |
|
|
28,991 |
|
|
|
40,845 |
|
CASH FLOWS FROM
FINANCING ACTIVITIES: |
|
|
|
|
|
|
Proceeds from issuance of
common stock |
|
|
— |
|
|
|
107 |
|
Net cash provided by financing
activities |
|
|
— |
|
|
|
107 |
|
Net increase in cash |
|
|
5,592 |
|
|
|
16,638 |
|
Cash, cash equivalents and
restricted cash at beginning of year |
|
|
10,809 |
|
|
|
28,948 |
|
Cash, cash equivalents and
restricted cash at end of period |
|
$ |
16,401 |
|
|
$ |
45,586 |
|
Reconciliation of
cash, cash equivalents and restricted cash: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
14,836 |
|
|
$ |
44,021 |
|
Restricted cash |
|
|
1,565 |
|
|
|
1,565 |
|
Total cash, cash equivalents and restricted cash |
|
$ |
16,401 |
|
|
$ |
45,586 |
|
Supplemental schedule
of non-cash investing and financing activities: |
|
|
|
|
|
|
Vesting of early exercised
options |
|
$ |
— |
|
|
$ |
2 |
|
Purchases of property and
equipment included in accounts payable and accrued liabilities |
|
$ |
46 |
|
|
$ |
231 |
|
Deferred offering costs in
accounts payable and accrued liabilities |
|
$ |
102 |
|
|
$ |
64 |
|
|
Investor Relations and Media Contacts: Karen L.
BergmanVice President, Communications and Investor RelationsBolt
Biotherapeutics, Inc.650-665-9295kbergman@boltbio.com
Sarah McCabeStern Investor Relations,
Inc.212-362-1200sarah.mccabe@sternir.com
David MelamedRusso Partners, LLC 212-845-4271
david.melamed@russopartnersllc.com
Bolt Biotherapeutics (NASDAQ:BOLT)
過去 株価チャート
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Bolt Biotherapeutics (NASDAQ:BOLT)
過去 株価チャート
から 5 2023 まで 5 2024