Bolt Biotherapeutics, Inc. (NASDAQ: BOLT), a clinical-stage
biotechnology company pioneering a new class of immuno-oncology
agents that combine the targeting precision of antibodies with the
power of both the innate and adaptive immune systems, today
reported financial results for the second quarter ended June 30,
2021 and provided an update on recent business highlights.
“We continue to build strong momentum with our business strategy
and remain on target for a BDC-1001 Phase 1/2 clinical data update
later this year,” said Randall C. Schatzman, Ph.D., Chief Executive
Officer of Bolt. “Our recently announced Genmab collaboration
expands our proprietary Boltbody platform into novel bispecific
ISAC applications, while fortifying our strong cash position.
Furthermore, our CEA-targeted candidate BDC-2034 made steady
progress towards an IND filing that is expected next year. I am
proud of the passionate and experienced team we have assembled at
Bolt, including recent additions to our leadership, who share our
commitment to advancing targeted immuno-oncology therapies that
will benefit patients with cancer.”
Recent Business Highlights and Anticipated
Milestones
- Lead program BDC-1001 on track for anticipated Phase
1/2 trial data update in 2H21 – In June 2021, Bolt
presented a poster at the 2021 American Society of Clinical
Oncology (ASCO) Annual Meeting that expanded on the preliminary
data, as of January 29, 2021, from the first 20 patients in an
ongoing BDC-1001 Phase 1/2 clinical trial. The monotherapy
dose-escalation portion of the trial is proceeding on plan, with a
further data update expected in the second half of 2021. This Phase
1/2 trial is being conducted in four parts: [1] Phase 1 monotherapy
dose escalation, [2] Phase 1 dose escalation in combination with
PD-1 checkpoint inhibitor, [3] Phase 2 monotherapy expansion
cohorts, and [4] Phase 2 expansion cohorts in combination with a
PD-1 checkpoint inhibitor. Bolt also remains on track to initiate
the monotherapy Phase 2 dose-expansion cohorts and the
dose-escalation of BDC-1001 in combination with an anti-PD-1
antibody in the second half of 2021.
- Announced oncology research and development (R&D)
collaboration with Genmab to develop multiple bispecific
ISACs – In June 2021, Bolt announced an oncology R&D
collaboration with Genmab to discover and evaluate novel bispecific
immune-stimulating antibody conjugate (ISAC) products for the
treatment of multiple types of cancer. The collaboration will
combine Bolt’s BoltBody™ ISAC platform with Genmab’s proprietary
antibodies and bispecific technology, and Genmab will fully fund
three programs through initial clinical proof-of-concept. Bolt
received a $10 million USD upfront payment and a $15 million USD
equity investment from Genmab, is eligible to receive up to $285
million USD for each program exclusively developed and
commercialized by Genmab, and has the option to participate in the
development and commercialization of one candidate after seeing
clinical proof-of-concept data.
- Expanded leadership team, adding expertise
across research, clinical development, regulatory, quality and
technical operations over the last year.
- Amreen Husain, M.D., Vice President, Clinical Development and
Translational Medicine. Dr. Husain brings more than a decade of
experience in oncology drug development with a focus on breast and
gynecological cancers and immuno-oncology. Dr. Husain joined Bolt
from Roche/Genentech. Prior, Dr. Husain was as a practicing
oncologist and clinical researcher at Stanford University Medical
Center.
- Bruce Hug, M.D., Ph.D., Vice President, Early Development and
Research Collaborations. Dr. Hug joins Bolt from GlaxoSmithKline,
bringing more than 16 years of oncology, hematology and
immunotherapy experience, with a focus on early development.
- Karen L. Bergman, Vice President, Communications and Investor
Relations. Ms. Bergman has more than two decades of experience in
biopharma communications, spanning corporate roles at companies
such as ALZA and FibroGen, and 15 years heading a life science
practice specializing in strategy, positioning, communications, and
investor relations.
- Liang Fang, Ph.D., Vice President, Biometrics and
Bioinformatics. Dr. Fang brings more than 15 years of experience in
developing and applying statistical methods and data sciences to
drug development in oncology and the biotechnology industry from
MyoKardia, Gilead Sciences, Genentech, and Amgen.
- Triona O’Hanlon, Vice President, Program Management. Ms.
O’Hanlon joined Bolt from Gilead, where she led program and
portfolio management for hematology/oncology and cell therapy. Ms.
O’Hanlon brings more than 20 years of experience in program and
alliance management from Gilead Sciences, Kite Pharma, Elan
Pharmaceuticals, and Ambit Biosciences.
- Wesley Burwell, Vice President, Head of Human Resources. Mr.
Burwell most recently worked at Global Blood Therapeutics and
brings more than 20 years of experience building and driving HR
strategy for biopharma companies.
- Cash, cash equivalents, and marketable securities were
$310.9 million as of June 30, 2021, which is expected to
fund operations and the advancement of its oncology product
pipeline to achieve multiple key milestones through the end of
2023.
Upcoming Events
- Bolt Biotherapeutics will be attending the following
conferences in September 2021:
- Citi’s 16th Annual Biopharma Virtual Conference, September
8-10
- Wells Fargo Virtual Healthcare Conference, September 9-10
- Morgan Stanley Global Healthcare Conference, September
9-15
- Cantor Fitzgerald Global Healthcare Conference, September
27-30
Second Quarter 2021 Financial Results
Cash Position – Cash, cash
equivalents, and marketable securities were $310.9 million as of
June 30, 2021, compared to $302.9 million as of March 31,
2021. Bolt expects its cash balance to fund operations through the
end of 2023.
Research and Development
Expenses – R&D expenses were $19.7 million
for the quarter ended June 30, 2021, compared to $9.2 million for
the same quarter in 2020, primarily due to increases in
manufacturing expenses related to BDC-1001 and BDC-2034, increased
personnel expenses relating to an increase in headcount, increased
facility-related expenses, and increased clinical trial
expenses.
General and Administrative (G&A)
Expenses – G&A expenses were $4.1 million
for the quarter ended June 30, 2021, compared to $2.0 million for
the same quarter in 2020, primarily due to increased personnel
expenses relating to an increase in headcount and increased
professional services expenses related to consulting services,
legal fees and other professional services.
Loss from Operations – Loss from
operations was $23.8 million for the quarter ended June 30, 2021
compared to $11.1 million for the same quarter in 2020.
About Bolt Biotherapeutics, Inc.Bolt
Biotherapeutics, Inc. is a clinical-stage biotechnology company
pioneering a new class of immuno-oncology agents that combine the
targeting precision of antibodies with the power of both the innate
and adaptive immune systems Bolt’s proprietary Boltbody™
Immune-stimulating Antibody Conjugate (ISAC) approach uses
immunostimulants to engage and activate myeloid cells that directly
kill tumor cells. This leads to the conversion of immunologically
“cold” tumors to “hot” tumors. Bolt’s lead candidate, BDC-1001, is
a Boltbody ISAC comprised of a HER2-targeting biosimilar of
trastuzumab conjugated to one of Bolt’s proprietary TLR7/8 agonists
for the treatment of patients with HER2-expressing solid tumors.
Bolt is also advancing additional Boltbody ISAC product candidates
targeting CEA and PD-L1. For more information, 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 enrollment for our ongoing Phase 1/2
trial for BDC-1001, the timing of our Phase 2 dose expansion and
the dose escalation in combination with an anti-PD-1 antibody, the
timing that BDC-2034 will enter clinical trials, the availability
of additional BDC-1001 clinical data by the end of 2021, the
initiation of the BDC-1001 monotherapy Phase 2 dose-expansion
cohorts in the second half of 2021, our ability to fund our
clinical programs and the sufficiency of our cash, cash
equivalents, and marketable securities to fund operations through
the end of 2023, our future results of operations, financial
condition, business strategy and plans and objectives of management
for future operations, 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,” “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. 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,
2020. 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, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
Collaboration revenue |
|
$ |
— |
|
|
$ |
67 |
|
|
$ |
— |
|
|
$ |
231 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
19,707 |
|
|
|
9,166 |
|
|
|
33,834 |
|
|
|
15,953 |
|
General and administrative |
|
|
4,054 |
|
|
|
2,011 |
|
|
|
8,353 |
|
|
|
4,133 |
|
Total
operating expense |
|
|
23,761 |
|
|
|
11,177 |
|
|
|
42,187 |
|
|
|
20,086 |
|
Loss
from operations |
|
|
(23,761 |
) |
|
|
(11,110 |
) |
|
|
(42,187 |
) |
|
|
(19,855 |
) |
Other
income (expense), net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
|
176 |
|
|
|
51 |
|
|
|
232 |
|
|
|
163 |
|
Change in fair value of preferred stock right liability |
|
|
— |
|
|
|
— |
|
|
|
(6,084 |
) |
|
|
— |
|
Total
other income (expense), net |
|
|
176 |
|
|
|
51 |
|
|
|
(5,852 |
) |
|
|
163 |
|
Net
loss |
|
|
(23,585 |
) |
|
|
(11,059 |
) |
|
|
(48,039 |
) |
|
|
(19,692 |
) |
Net unrealized gain (loss) on marketable securities |
|
|
41 |
|
|
|
11 |
|
|
|
(23 |
) |
|
|
1 |
|
Comprehensive loss |
|
$ |
(23,544 |
) |
|
$ |
(11,048 |
) |
|
$ |
(48,062 |
) |
|
$ |
(19,691 |
) |
Net loss
per share, basic and diluted |
|
$ |
(0.64 |
) |
|
$ |
(5.29 |
) |
|
$ |
(1.65 |
) |
|
$ |
(9.45 |
) |
Weighted-average shares outstanding, basic and diluted |
|
|
36,595,112 |
|
|
|
2,089,320 |
|
|
|
29,088,267 |
|
|
|
2,083,197 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BOLT BIOTHERAPEUTICS,
INC.CONDENSED BALANCE
SHEETS(Unaudited, in thousands)
|
|
June 30, |
|
December 31, |
|
|
2021 |
|
2020 |
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
58,302 |
|
|
$ |
5,542 |
|
Short-term investments |
|
|
186,686 |
|
|
|
17,296 |
|
Prepaid expenses and other current assets |
|
|
3,163 |
|
|
|
2,523 |
|
Total
current assets |
|
|
248,151 |
|
|
|
25,361 |
|
Property
and equipment, net |
|
|
4,551 |
|
|
|
4,083 |
|
Operating lease right-of-use assets |
|
|
25,977 |
|
|
|
12,267 |
|
Finance
lease right-of-use assets |
|
|
25 |
|
|
|
34 |
|
Restricted cash |
|
|
1,565 |
|
|
|
1,565 |
|
Deferred
offering costs |
|
|
— |
|
|
|
2,357 |
|
Long-term investments |
|
|
65,938 |
|
|
|
— |
|
Other
assets |
|
|
867 |
|
|
|
875 |
|
Total
assets |
|
$ |
347,074 |
|
|
$ |
46,542 |
|
Liabilities, convertible preferred stock, and stockholders'
equity (deficit) |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
1,614 |
|
|
$ |
1,598 |
|
Accrued expenses and other current liabilities |
|
|
10,983 |
|
|
|
6,663 |
|
Deferred revenue |
|
|
4,330 |
|
|
|
1,502 |
|
Operating lease liabilities |
|
|
2,323 |
|
|
|
1,501 |
|
Total
current liabilities |
|
|
19,250 |
|
|
|
11,264 |
|
Operating lease liabilities, net of current portion |
|
|
23,160 |
|
|
|
9,376 |
|
Deferred
revenue, non-current |
|
|
8,535 |
|
|
|
— |
|
Convertible preferred stock purchase right liability,
non-current |
|
|
— |
|
|
|
25,224 |
|
Other
long-term liabilities |
|
|
233 |
|
|
|
329 |
|
Total liabilities |
|
|
51,178 |
|
|
|
46,193 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Convertible preferred stock |
|
|
— |
|
|
|
105,296 |
|
Stockholders' equity (deficit): |
|
|
|
|
|
|
|
|
Common
stock |
|
|
— |
|
|
|
— |
|
Additional paid-in capital |
|
|
452,357 |
|
|
|
3,452 |
|
Accumulated other comprehensive loss |
|
|
(23 |
) |
|
|
— |
|
Accumulated deficit |
|
|
(156,438 |
) |
|
|
(108,399 |
) |
Total stockholders' equity (deficit): |
|
|
295,896 |
|
|
|
(104,947 |
) |
Total
liabilities, convertible preferred stock, and stockholders' equity
(deficit) |
|
$ |
347,074 |
|
|
$ |
46,542 |
|
|
|
|
|
|
|
|
|
|
BOLT BIOTHERAPEUTICS,
INC.CONDENSED STATEMENTS OF CASH
FLOWS(Unaudited, in thousands)
|
|
Six Months Ended June 30, |
|
|
2021 |
|
2020 |
CASH FLOWS FROM OPERATING ACTIVITIES: |
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(48,039 |
) |
|
$ |
(19,692 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
528 |
|
|
|
211 |
|
Stock-based compensation expense |
|
|
4,132 |
|
|
|
448 |
|
Accretion of premium/discount on marketable securities |
|
|
1,034 |
|
|
|
(53 |
) |
Unrealized gain (loss) on marketable securities, net |
|
|
(23 |
) |
|
|
1 |
|
Change in fair value of convertible preferred stock purchase rights
liabilities |
|
|
6,084 |
|
|
|
— |
|
Non-cash lease expense |
|
|
1,174 |
|
|
|
885 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaid expenses and other assets |
|
|
(632 |
) |
|
|
(382 |
) |
Accounts payable and accrued expenses |
|
|
4,110 |
|
|
|
(438 |
) |
Operating lease liabilities |
|
|
(278 |
) |
|
|
(2,821 |
) |
Deferred revenue |
|
|
11,363 |
|
|
|
(69 |
) |
Other long-term liabilities |
|
|
2 |
|
|
|
7 |
|
Net cash
used in operating activities |
|
|
(20,545 |
) |
|
|
(21,903 |
) |
CASH FLOWS FROM INVESTING ACTIVITIES: |
|
|
|
|
|
|
|
|
Purchase
of property and equipment |
|
|
(761 |
) |
|
|
(1,213 |
) |
Purchases of marketable securities |
|
|
(247,768 |
) |
|
|
(13,235 |
) |
Maturities of marketable securities |
|
|
11,406 |
|
|
|
5,247 |
|
Net cash
used in investing activities |
|
|
(237,123 |
) |
|
|
(9,201 |
) |
CASH FLOWS FROM FINANCING ACTIVITIES: |
|
|
|
|
|
|
|
|
Proceeds
from issuance of preferred stock, net of issuance cost |
|
|
51,902 |
|
|
|
41,546 |
|
Proceeds
from initial public offering, net of issuance cost |
|
|
244,316 |
|
|
|
— |
|
Proceeds
from issuance of common stock related to stock purchase
agreement |
|
|
13,638 |
|
|
|
— |
|
Proceeds
from issuance of common stock |
|
|
572 |
|
|
|
39 |
|
Net cash
provided by financing activities |
|
|
310,428 |
|
|
|
41,585 |
|
Net
increase in cash |
|
|
52,760 |
|
|
|
10,481 |
|
Cash,
cash equivalents and restricted cash at beginning of year |
|
|
7,107 |
|
|
|
35,410 |
|
Cash,
cash equivalents and restricted cash at end of period |
|
$ |
59,867 |
|
|
$ |
45,891 |
|
Reconciliation of cash, cash equivalents and restricted
cash: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
58,302 |
|
|
$ |
45,307 |
|
Restricted cash |
|
|
1,565 |
|
|
|
584 |
|
Total cash, cash equivalents and restricted cash |
|
$ |
59,867 |
|
|
$ |
45,891 |
|
Supplemental schedule of non-cash investing and financing
activities: |
|
|
|
|
|
|
|
|
Vesting
of early exercised options |
|
$ |
98 |
|
|
$ |
9 |
|
Purchases of property and equipment included in accounts payable
and accrued liabilities |
|
$ |
226 |
|
|
$ |
280 |
|
Deferred
offering costs in accounts payable and accrued liabilities |
|
$ |
— |
|
|
$ |
216 |
|
Right of
use assets obtained in exchange for operating lease
obligations |
|
$ |
14,884 |
|
|
$ |
324 |
|
|
|
|
|
|
|
|
|
|
Investor Relations and Media Contacts: Karen L.
BergmanVice President, Communications and Investor RelationsBolt
Biotherapeutics, Inc.650-665-9295 kbergman@boltbio.com
Sarah McCabeStern Investor Relations,
Inc.212-362-1200sarah.mccabe@sternir.com
Maggie Beller or David Schull Russo Partners, LLC 646-942-5631
maggie.beller@russopartnersllc.com
david.schull@russopartnersllc.com
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