Bolt Biotherapeutics Reports Third Quarter 2023 Financial Results and Provides Business Update
10 11월 2023 - 6:05AM
Bolt Biotherapeutics (Nasdaq: BOLT), a clinical-stage
biopharmaceutical company developing novel immunotherapies for the
treatment of cancer, today reported financial results for the third
quarter ended September 30, 2023, and provided an update on the
continued advancement of its clinical programs.
“During the quarter, we continued to advance our proprietary
clinical stage development programs, BDC-1001 and BDC-3042,” said
Randall Schatzman, Ph.D., Chief Executive Officer. “Updated Phase 1
data on BDC-1001 presented at this year’s ESMO Congress
demonstrated improved efficacy, including our first complete
response, and longer durability. We also recently received Orphan
Drug Designation from the FDA for BDC-1001 in gastric cancers, one
of the four types of cancer we are exploring in our BDC-1001 Phase
2 program. We look forward to presenting initial data from these
Phase 2 trials in 2024.”
“In addition, we administered BDC-3042 to the first patient in
our first-in-human Phase 1/2 clinical study evaluating BDC-3042 in
patients with six different types of solid tumors. As we approach
the end of the year, we are encouraged by the continued progress in
our research and clinical studies and look forward to generating
breakthroughs for patients in need of new treatment options that
work with the person’s body, not against it.”
Recent Highlights and Anticipated
Milestones
- Updated clinical data from Phase 1 dose-escalation
trial of BDC-1001 in HER2-expressing solid tumors presented at the
ESMO 2023 Congress in October 2023. The presentation was
given by Bob T. Li, M.D., Ph.D., MPH, medical oncologist and
principal investigator at Memorial Sloan Kettering Cancer Center
(MSK). Improvements in BDC-1001 efficacy were observed since the
data presented at ASCO in June 2023, including one new complete
response (CR) observed in the monotherapy arm. BDC-1001 achieved a
29% objective response rate (ORR) in evaluable patients with
HER2-positive tumors as monotherapy as well as a 29% ORR in
combination with nivolumab at the recommended Phase 2 dose (RP2D).
BDC-1001 was extremely well tolerated, with no Grade 5
treatment-related treatment-emergent adverse events (TEAEs), 1
Grade 4 TEAE (1%), and 9 Grade 3 TEAEs (7%). The most common TEAE
was Grade 1 or 2 infusion-related reactions, which were seen in 30%
of patients in the study. BDC-1001 upregulated gene signatures of
an innate and adaptive immune response in clinical responders,
providing support for the immune mechanism of action of our ISAC
technology. The data also provided support for the every-other week
(q2w) dosing schedule by demonstrating that innate and adaptive
immune gene signatures were increased in patients dosed q2w.
- First patient administered BDC-3042 in Phase 1 study of
patients with advanced cancers in October 2023.
BDC-3042 is a proprietary agonist antibody that targets Dectin-2,
an immune-activating receptor expressed by tumor-associated
macrophages (TAMs). This single-agent, dose-escalation Phase 1
clinical study will evaluate BDC-3042 in patients with metastatic
or unresectable triple-negative breast cancer (TNBC), colorectal
cancer, clear cell renal cell carcinoma, head and neck cancer,
non-small cell lung cancer (NSCLC), or ovarian cancer.
- Received Orphan Drug Designation for BDC-1001 for the
treatment of gastric cancers in September 2023. The Office
of Orphan Products Development of FDA grants Orphan Drug
Designation to drugs and biologics intended for the treatment,
diagnosis, or prevention of rare diseases, or conditions affecting
fewer than 200,000 people in the United States. The designation
affords Bolt the potential for certain benefits, including up to
seven years of post-approval market exclusivity, assistance in the
drug development process, tax credits for clinical development, and
exemptions from certain FDA fees.
- Presented four posters at the Society for Immunotherapy
of Cancer (SITC) 38th Annual
Meeting in November 2023. In the presentations, we
shared preclinical data illustrating the benefits of combining
BDC-1001 with the anti-HER2 antibody pertuzumab, along with
trial-in-progress updates for BDC-1001 and BDC-3042. We also
debuted our Claudin 18.2 ISAC program for the first time,
demonstrating anti-tumor activity in multiple preclinical
models.
- Announced issuance of U.S. patent covering
Dectin-2-targeting agonist antibodies, including
BDC-3042 in September 2023. This patent covers
antibodies with a novel mechanism of action that leverages Dectin-2
agonism to repolarize tumor-associated macrophages into
immunostimulatory, anti-tumor macrophages. The claims of the patent
will be valid through May 2041, excluding any patent term
adjustments or extensions which may provide additional
protection.
- Cash, cash equivalents, and marketable securities were
$141.4 million as of September 30, 2023. Cash on hand
is expected to fund multiple milestones and operations through
2025.
Third Quarter 2023 Financial Results
- Collaboration Revenue – Collaboration
revenue was $2.5 million for the quarter ended September 30, 2023,
compared to $2.1 million for the same quarter in 2022. Revenue in
the comparative periods was generated from the services performed
under the R&D collaborations as we fulfill our performance
obligations.
- Research and Development (R&D) Expenses
– R&D expenses were $15.0 million for the quarter
ended September 30, 2023, compared to $19.0 million for the same
quarter in 2022. The decrease in R&D expenses was due to lower
manufacturing expenses primarily related to the timing of batch
production of our product candidates and lower clinical expenses
due to lower site and patient costs, offset by higher contract
service expenses and salary and related expenses.
- General and Administrative (G&A) Expenses
– G&A expenses were $5.8 million for the quarter
ended September 30, 2023, compared to $5.5 million for the same
quarter in 2022.
- Loss from Operations – Loss from
operations was $18.2 million for the quarter ended September 30,
2023, compared to $22.3 million for the same quarter 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) 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
leveraging the immune system for a better way to treat cancer. The
company is developing novel immunotherapies using an approach that
teaches the immune system to recognize and kill cancer in a way
that is immediately personalized to each patient. Its pipeline
candidates are built on the Company’s deep expertise in myeloid
biology and cancer drug development and include BDC-1001, a
HER2-targeting Boltbody™ Immune-Stimulating Antibody Conjugate
(ISAC) being evaluated in a Phase 2 trial, and BDC-3042, a
myeloid-modulating agonist antibody targeting Dectin-2, being
evaluated in a Phase 1 trial. 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 our
clinical trials the timing of our presentation of initial data from
our BDC-1001 Phase 2 trials, the success of our clinical
collaborations, our ability to fund our clinical programs and the
sufficiency of our cash, cash equivalents, and marketable
securities, our future results of operations, financial condition,
business strategy and plans and objectives of management, 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.
Investor Relations and Media Contact:Maeve
ConneightonArgot Partners(212)
600-1902boltbio@argotpartners.com
BOLT BIOTHERAPEUTICS, INC. |
CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
(Unaudited, in thousands, except share and per share
amounts) |
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Collaboration revenue |
|
$ |
2,528 |
|
|
$ |
2,112 |
|
|
$ |
5,787 |
|
|
$ |
4,318 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
14,951 |
|
|
|
18,973 |
|
|
|
45,220 |
|
|
|
56,278 |
|
General and administrative |
|
|
5,760 |
|
|
|
5,485 |
|
|
|
16,997 |
|
|
|
17,321 |
|
Total operating expense |
|
|
20,711 |
|
|
|
24,458 |
|
|
|
62,217 |
|
|
|
73,599 |
|
Loss from operations |
|
|
(18,183 |
) |
|
|
(22,346 |
) |
|
|
(56,430 |
) |
|
|
(69,281 |
) |
Other income, net |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
1,926 |
|
|
|
587 |
|
|
|
5,136 |
|
|
|
1,180 |
|
Total other income, net |
|
|
1,926 |
|
|
|
587 |
|
|
|
5,136 |
|
|
|
1,180 |
|
Net
loss |
|
|
(16,257 |
) |
|
|
(21,759 |
) |
|
|
(51,294 |
) |
|
|
(68,101 |
) |
Net unrealized gain (loss) on marketable securities |
|
|
55 |
|
|
|
94 |
|
|
|
745 |
|
|
|
(1,388 |
) |
Comprehensive loss |
|
$ |
(16,202 |
) |
|
$ |
(21,665 |
) |
|
$ |
(50,549 |
) |
|
$ |
(69,489 |
) |
Net
loss per share, basic and diluted |
|
$ |
(0.43 |
) |
|
$ |
(0.58 |
) |
|
$ |
(1.36 |
) |
|
$ |
(1.83 |
) |
Weighted-average shares outstanding, basic and diluted |
|
|
37,868,480 |
|
|
|
37,454,340 |
|
|
|
37,768,308 |
|
|
|
37,293,121 |
|
BOLT BIOTHERAPEUTICS, INC. |
CONDENSED BALANCE SHEETS |
(Unaudited, in thousands) |
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
9,160 |
|
|
$ |
9,244 |
|
Short-term investments |
|
|
110,564 |
|
|
|
159,644 |
|
Prepaid expenses and other current assets |
|
|
5,742 |
|
|
|
3,858 |
|
Total current assets |
|
|
125,466 |
|
|
|
172,746 |
|
Property and equipment, net |
|
|
5,266 |
|
|
|
6,453 |
|
Operating lease right-of-use assets |
|
|
19,878 |
|
|
|
22,072 |
|
Restricted cash |
|
|
1,765 |
|
|
|
1,565 |
|
Long-term investments |
|
|
21,638 |
|
|
|
23,943 |
|
Other assets |
|
|
1,342 |
|
|
|
1,028 |
|
Total assets |
|
$ |
175,355 |
|
|
$ |
227,807 |
|
Liabilities and stockholders' equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
3,682 |
|
|
$ |
3,594 |
|
Accrued expenses and other current liabilities |
|
|
10,451 |
|
|
|
15,140 |
|
Deferred revenue |
|
|
1,938 |
|
|
|
1,993 |
|
Operating lease liabilities |
|
|
2,680 |
|
|
|
2,391 |
|
Total current liabilities |
|
|
18,751 |
|
|
|
23,118 |
|
Operating lease liabilities, net of current portion |
|
|
18,177 |
|
|
|
20,220 |
|
Deferred revenue, non-current |
|
|
10,125 |
|
|
|
12,921 |
|
Other long-term liabilities |
|
|
43 |
|
|
|
42 |
|
Total liabilities |
|
|
47,096 |
|
|
|
56,301 |
|
Commitments and contingencies |
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
1 |
|
|
|
— |
|
Additional paid-in capital |
|
|
474,814 |
|
|
|
467,513 |
|
Accumulated other comprehensive loss |
|
|
(174 |
) |
|
|
(919 |
) |
Accumulated deficit |
|
|
(346,382 |
) |
|
|
(295,088 |
) |
Total stockholders' equity: |
|
|
128,259 |
|
|
|
171,506 |
|
Total liabilities and stockholders' equity |
|
$ |
175,355 |
|
|
$ |
227,807 |
|
|
|
|
|
|
|
|
BOLT BIOTHERAPEUTICS, INC. |
CONDENSED STATEMENTS OF CASH FLOWS |
(Unaudited, in thousands) |
|
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
Net loss |
|
$ |
(51,294 |
) |
|
$ |
(68,101 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
Depreciation and amortization |
|
|
1,387 |
|
|
|
1,204 |
|
Stock-based compensation expense |
|
|
7,155 |
|
|
|
7,453 |
|
Accretion (amortization) of premium/discount on marketable
securities |
|
|
(3,299 |
) |
|
|
655 |
|
Non-cash lease expense |
|
|
2,194 |
|
|
|
2,520 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
Prepaid expenses and other assets |
|
|
(2,198 |
) |
|
|
(713 |
) |
Accounts payable and accrued expenses |
|
|
(4,601 |
) |
|
|
2,481 |
|
Operating lease liabilities |
|
|
(1,754 |
) |
|
|
(1,966 |
) |
Deferred revenue |
|
|
(2,851 |
) |
|
|
(2,079 |
) |
Other long-term liabilities |
|
|
1 |
|
|
|
(6 |
) |
Net
cash used in operating activities |
|
|
(55,260 |
) |
|
|
(58,552 |
) |
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
Purchase of property and equipment |
|
|
(200 |
) |
|
|
(1,769 |
) |
Purchases of marketable securities |
|
|
(132,828 |
) |
|
|
(155,345 |
) |
Maturities of marketable securities |
|
|
188,257 |
|
|
|
198,541 |
|
Net
cash provided by investing activities |
|
|
55,229 |
|
|
|
41,427 |
|
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
Proceeds from issuance of common stock |
|
|
147 |
|
|
|
359 |
|
Net
cash provided by financing activities |
|
|
147 |
|
|
|
359 |
|
Net
increase (decrease) in cash |
|
|
116 |
|
|
|
(16,766 |
) |
Cash, cash equivalents and restricted cash at beginning of
year |
|
|
10,809 |
|
|
|
28,948 |
|
Cash, cash equivalents and restricted cash at end of period |
|
$ |
10,925 |
|
|
$ |
12,182 |
|
Reconciliation of cash, cash equivalents and restricted
cash: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
9,160 |
|
|
$ |
10,617 |
|
Restricted cash |
|
|
1,765 |
|
|
|
1,565 |
|
Total cash, cash equivalents and restricted cash |
|
$ |
10,925 |
|
|
$ |
12,182 |
|
Supplemental schedule of non-cash investing and financing
activities: |
|
|
|
|
|
|
Vesting of early exercised options |
|
$ |
— |
|
|
$ |
4 |
|
Purchases of property and equipment included in accounts payable
and accrued liabilities |
|
$ |
— |
|
|
$ |
182 |
|
Deferred offering costs in accounts payable and accrued
liabilities |
|
$ |
102 |
|
|
$ |
102 |
|
Right of use assets obtained in exchange for operating lease
obligations |
|
$ |
— |
|
|
$ |
852 |
|
Bolt Biotherapeutics (NASDAQ:BOLT)
과거 데이터 주식 차트
부터 4월(4) 2024 으로 5월(5) 2024
Bolt Biotherapeutics (NASDAQ:BOLT)
과거 데이터 주식 차트
부터 5월(5) 2023 으로 5월(5) 2024