Bolt Biotherapeutics Reports Second Quarter 2023 Financial Results and Provides Business Update
August 07 2023 - 4:10PM
Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage
biopharmaceutical company developing novel immunotherapies for the
treatment of cancer, today reported financial results for the
second quarter ended June 30, 2023 and provided an update on the
continued advancement of its clinical programs.
“We have extended our leadership position in immunotherapy as
the first company to initiate a Phase 2 program for an ISAC,” said
Randall Schatzman, Ph.D., Chief Executive Officer. “The FDA has
also cleared the IND for BDC-3042, the first and only program
targeting Dectin-2 with an agonist antibody. This is our second
successful IND and we expect to begin this first-in-human clinical
trial later this year. We presented positive data at ASCO and look
forward to presenting more data at ESMO and other upcoming major
medical meetings. Our team is highly motivated by all of this
positive momentum and the opportunities for us to make a difference
for cancer patients.”
“The data in the Phase 1 dose-escalation trial of BDC-1001
included durable objective clinical responses and a favorable
safety profile. Importantly, these data provide clinical validation
of our Boltbody™ ISAC approach, which has the potential to deliver
a novel mechanism for the treatment of HER2-positive cancers and
shows promise for patients who are resistant to current therapies
on the market.”
Recent Highlights and Anticipated
Milestones
- Comprehensive safety and efficacy data from the
BDC-1001 Phase 1 dose-escalation study presented at the American
Society of Oncology (ASCO) Annual Meeting in June 2023 by
Bob T. Li, M.D., Ph.D., MPH, medical oncologist and principal
investigator at Memorial Sloan Kettering Cancer Center (MSK).
BDC-1001 achieved a 29% objective response rate in evaluable
patients with HER2-positive tumors, both as monotherapy and in
combination with nivolumab at the recommended Phase 2 dose (RP2D).
The percentage of evaluable patients with HER2-positive tumors who
experienced PRs or at least 24 weeks of disease control was 43% in
the monotherapy arm and 57% in combination with nivolumab. These
data supported the selection of 20 mg/kg dosed every other week
(q2w) as the RP2D for the BDC-1001 Phase 2 clinical program.
- First patients dosed in BDC-1001 Phase 2 dose-expansion
study in August 2023. This study is investigating BDC-1001
initially as single-agent monotherapy in three separate cohorts:
HER2-positive colorectal, endometrial, and gastroesophageal
cancer.A second Phase 2 study is evaluating BDC-1001 as monotherapy
and in combination with pertuzumab for the treatment of patients
with HER2-positive metastatic breast cancer whose disease has
progressed following treatment with Enhertu®.
- FDA clears IND for BDC-3042
in July 2023. BDC-3042 is a proprietary agonist antibody that
targets Dectin-2, an immune-activating receptor expressed by
tumor-associated macrophages (TAMs). The Company remains on track
to initiate a Phase 1 clinical study of BDC-3042 in solid tumors
later in 2023.
- Additional BDC-1001 clinical and biomarker data will be
presented in a mini-oral session at ESMO Congress 2023.
The presentation, “Recommended phase 2 dose (RP2D) selection and
pharmacodynamic (PD) data of the first-in-human immune-stimulating
antibody conjugate (ISAC) BDC-1001 in patients (pts) with advanced
HER2-expressing solid tumors,” will be made by Bob T. Li, M.D.,
Ph.D., MPH, October 20-24 in Madrid, Spain.
- Cash, cash equivalents, and marketable securities were
$157.1 million as of June 30, 2023. Cash on hand is
expected to fund multiple milestones and operations through
2025.
Upcoming Events
- Bolt Biotherapeutics will participate in upcoming
conferences:
- BTIG Virtual Biotechnology Conference 2023, August 7-9
- Morgan Stanley Annual Global Healthcare Conference, September
11-13 in New York, NY
- H.C. Wainwright 25th Annual Global Investment Conference,
September 11-13 in New York, NY
Second Quarter 2023 Financial Results
- Collaboration Revenue – Collaboration revenue
was $1.4 million for each of the quarters ended June 30, 2023, and
2022. Revenue in the comparative periods were 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 $15.6 million for the quarter ended June 30,
2023, compared to $18.9 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 lab supplies and contract service expenses,
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
June 30, 2023, compared to $5.5 million for the same quarter in
2022.
- Loss from Operations – Loss from operations
was $19.8 million for the quarter ended June 30, 2023, compared to
$23.1 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) 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 BDC-1001, a HER2-targeting Boltbody™
Immune-Stimulating Antibody Conjugate (ISAC); BDC-3042, a
myeloid-modulating antibody; and multiple Boltbody ISAC
collaboration programs. BDC-1001 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 expected 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 also
developing multiple Boltbody™ ISACs in strategic collaborations
with leading biopharmaceutical companies. For more information,
please visit https://www.boltbio.com/
Forward-Looking Statements This 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 the completion of our monotherapy
and combination cohorts, the timing of our initiation of clinical
development of BDC-3042, the success of our clinical
collaborations, the ability of our clinical collaboration partners
to supply nivolumab and pertuzumab, 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.
BOLT BIOTHERAPEUTICS,
INC.CONDENSED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS(Unaudited, in thousands, except
share and per share amounts)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Collaboration revenue |
|
$ |
1,433 |
|
|
$ |
1,393 |
|
|
$ |
3,259 |
|
|
$ |
2,206 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
15,644 |
|
|
|
18,920 |
|
|
|
30,269 |
|
|
|
37,305 |
|
General and administrative |
|
|
5,621 |
|
|
|
5,532 |
|
|
|
11,237 |
|
|
|
11,836 |
|
Total operating expense |
|
|
21,265 |
|
|
|
24,452 |
|
|
|
41,506 |
|
|
|
49,141 |
|
Loss from operations |
|
|
(19,832 |
) |
|
|
(23,059 |
) |
|
|
(38,247 |
) |
|
|
(46,935 |
) |
Other income, net |
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
1,775 |
|
|
|
395 |
|
|
|
3,210 |
|
|
|
593 |
|
Total other income, net |
|
|
1,775 |
|
|
|
395 |
|
|
|
3,210 |
|
|
|
593 |
|
Net loss |
|
|
(18,057 |
) |
|
|
(22,664 |
) |
|
|
(35,037 |
) |
|
|
(46,342 |
) |
Net unrealized gain (loss) on marketable securities |
|
|
6 |
|
|
|
(407 |
) |
|
|
690 |
|
|
|
(1,482 |
) |
Comprehensive loss |
|
$ |
(18,051 |
) |
|
$ |
(23,071 |
) |
|
$ |
(34,347 |
) |
|
$ |
(47,824 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.48 |
) |
|
$ |
(0.61 |
) |
|
$ |
(0.93 |
) |
|
$ |
(1.25 |
) |
Weighted-average shares
outstanding, basic and diluted |
|
|
37,750,393 |
|
|
|
37,293,557 |
|
|
|
37,717,391 |
|
|
|
37,211,174 |
|
BOLT BIOTHERAPEUTICS,
INC.CONDENSED BALANCE
SHEETS(Unaudited, in thousands)
|
|
June 30, |
|
|
December 31, |
|
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
13,451 |
|
|
$ |
9,244 |
|
Short-term investments |
|
|
112,415 |
|
|
|
159,644 |
|
Prepaid expenses and other current assets |
|
|
4,802 |
|
|
|
3,858 |
|
Total current assets |
|
|
130,668 |
|
|
|
172,746 |
|
Property and equipment, net |
|
|
5,609 |
|
|
|
6,453 |
|
Operating lease right-of-use
assets |
|
|
20,622 |
|
|
|
22,072 |
|
Restricted cash |
|
|
1,565 |
|
|
|
1,565 |
|
Long-term investments |
|
|
31,220 |
|
|
|
23,943 |
|
Other assets |
|
|
1,012 |
|
|
|
1,028 |
|
Total assets |
|
$ |
190,696 |
|
|
$ |
227,807 |
|
Liabilities and
stockholders' equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
3,436 |
|
|
$ |
3,594 |
|
Accrued expenses and other current liabilities |
|
|
9,916 |
|
|
|
15,140 |
|
Deferred revenue |
|
|
1,685 |
|
|
|
1,993 |
|
Operating lease liabilities |
|
|
2,581 |
|
|
|
2,391 |
|
Total current liabilities |
|
|
17,618 |
|
|
|
23,118 |
|
Operating lease liabilities, net
of current portion |
|
|
18,891 |
|
|
|
20,220 |
|
Deferred revenue,
non-current |
|
|
12,012 |
|
|
|
12,921 |
|
Other long-term liabilities |
|
|
43 |
|
|
|
42 |
|
Total liabilities |
|
|
48,564 |
|
|
|
56,301 |
|
Commitments and
contingencies |
|
|
|
|
|
|
Stockholders'
equity: |
|
|
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
1 |
|
|
|
— |
|
Additional paid-in capital |
|
|
472,485 |
|
|
|
467,513 |
|
Accumulated other comprehensive
loss |
|
|
(229 |
) |
|
|
(919 |
) |
Accumulated deficit |
|
|
(330,125 |
) |
|
|
(295,088 |
) |
Total stockholders' equity: |
|
|
142,132 |
|
|
|
171,506 |
|
Total liabilities and
stockholders' equity |
|
$ |
190,696 |
|
|
$ |
227,807 |
|
|
|
|
|
|
|
|
BOLT BIOTHERAPEUTICS,
INC.CONDENSED STATEMENTS OF CASH
FLOWS(Unaudited, in thousands)
|
|
Six Months Ended June 30, |
|
|
|
2023 |
|
|
2022 |
|
CASH FLOWS FROM OPERATING
ACTIVITIES: |
|
|
|
|
|
|
Net loss |
|
$ |
(35,037 |
) |
|
$ |
(46,342 |
) |
Adjustments to reconcile net loss
to net cash used in operating activities: |
|
|
|
|
|
|
Depreciation and amortization |
|
|
925 |
|
|
|
765 |
|
Stock-based compensation expense |
|
|
4,826 |
|
|
|
5,310 |
|
Accretion of premium/discount on marketable securities |
|
|
(1,964 |
) |
|
|
693 |
|
Non-cash lease expense |
|
|
1,450 |
|
|
|
1,838 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
Prepaid expenses and other assets |
|
|
(928 |
) |
|
|
(1,941 |
) |
Accounts payable and accrued expenses |
|
|
(5,428 |
) |
|
|
(3,087 |
) |
Operating lease liabilities |
|
|
(1,139 |
) |
|
|
(1,461 |
) |
Deferred revenue |
|
|
(1,217 |
) |
|
|
(870 |
) |
Other long-term liabilities |
|
|
1 |
|
|
|
(6 |
) |
Net cash used in operating
activities |
|
|
(38,511 |
) |
|
|
(45,101 |
) |
CASH FLOWS FROM INVESTING
ACTIVITIES: |
|
|
|
|
|
|
Purchase of property and
equipment |
|
|
(35 |
) |
|
|
(1,034 |
) |
Purchases of marketable
securities |
|
|
(96,524 |
) |
|
|
(107,433 |
) |
Maturities of marketable
securities |
|
|
139,130 |
|
|
|
148,444 |
|
Net cash provided by investing
activities |
|
|
42,571 |
|
|
|
39,977 |
|
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 |
|
|
4,207 |
|
|
|
(4,765 |
) |
Cash, cash equivalents and
restricted cash at beginning of year |
|
|
10,809 |
|
|
|
28,948 |
|
Cash, cash equivalents and
restricted cash at end of period |
|
$ |
15,016 |
|
|
$ |
24,183 |
|
Reconciliation of cash,
cash equivalents and restricted cash: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
13,451 |
|
|
$ |
22,618 |
|
Restricted cash |
|
|
1,565 |
|
|
|
1,565 |
|
Total cash, cash equivalents and restricted cash |
|
$ |
15,016 |
|
|
$ |
24,183 |
|
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 |
|
$ |
46 |
|
|
$ |
98 |
|
Deferred offering costs in
accounts payable and accrued liabilities |
|
$ |
102 |
|
|
$ |
102 |
|
Investor Relations and Media Contacts:
Paige KellyStern Investor Relations,
Inc.212-698-8699Paige.kelly@sternir.com
David SchullRusso Partners, LLC
858-717-2310david.schull@russopartnersllc.com
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