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 fourth quarter and full year
ended December 31, 2020 and provided an update on recent business
highlights.
“Our upsized Initial Public Offering, which we completed in
February 2021, leaves us in a strong financial position to execute
on our vision of developing this new class of immuno-oncology
products to help patients. We continue to enroll patients in the
dose escalation part of our Phase 1/2 trial for our lead candidate,
BDC-1001, for the treatment of patients with HER2-expressing solid
tumors. We reported preliminary clinical results from an initial 20
patients at a data cutoff of January 29, 2021, which demonstrated 4
patients with stable disease and one patient with a confirmed
partial response. We’re looking forward to completing the dose
escalation and initiating both the monotherapy Phase 2 dose
expansions part and the combination studies with an anti-PD-1
antibody part later in 2021,” said Randall C. Schatzman, Ph.D.,
Chief Executive Officer of Bolt. “We continue to progress our
broader pipeline of targeted immunotherapies derived from our
Boltbody™ ISAC platform, a novel technology that can be applied
across a diverse range of tumor targets and has the potential to
enable cancer patients to generate immunological memory against
their own tumors. We plan to advance our second Boltbody ISAC
BDC-2034, which targets the cancer antigen CEA, into the clinic in
2022.”
Recent Business Highlights and Anticipated
Milestones
- Completed upsized Initial Public Offering in February
2021 – In February 2021, Bolt completed its Initial Public
Offering (IPO) of 13,225,000 shares of common stock, inclusive of
the full exercise by the underwriters of their option to purchase
1,725,000 shares, at a public offering price of $20.00 per share.
Gross proceeds from the IPO were $264.5 million and net proceeds
from the offering, after deducting underwriting discounts,
commissions and offering expenses, were approximately $241.7
million.
- Reported preliminary clinical results from the first 20
patients from the ongoing Phase 1/2 trial of lead candidate
BDC-1001 for the treatment of patients with HER2-expressing solid
tumors –BDC-1001 is a human epidermal growth factor
receptor 2, or HER2, Boltbody Immune-Stimulating Antibody Conjugate
(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, including
HER2-low tumors. A Phase 1/2 study evaluating BDC-1001 in patients
with HER2-expressing cancers, which includes patients with breast
and gastric cancers that are refractory to Herceptin® and Kadcyla®,
as well as cancers for which no HER2-targeting therapies have yet
been approved, is ongoing. Bolt is currently enrolling patients in
the dose escalation portion of the trial. As of January 29, 2021,
Bolt had treated 20 patients and BDC-1001 appeared to be well
tolerated with mild to moderate adverse events and no dose-limiting
toxicities or drug-related serious adverse events were observed.
Clinical activity was seen in the form of stable disease,
reductions in tumor volume including a confirmed partial response
and increases in pharmacodynamic markers that Bolt believes are
consistent with its proposed mechanism of action. Later this year,
Bolt plans to advance to part 3 of the trial, monotherapy Phase 2
dose expansion cohorts, and part 2, BDC-1001 dose escalation in
combination with an anti-PD-1 antibody.
- Strengthened Board of
Directors with appointment of Kathleen LaPorte – In
January 2021, Kathleen LaPorte joined the Board of Directors as
Chair of Bolt’s Audit Committee. Ms. LaPorte has more than 30 years
of experience in building and operating private and public biotech
companies as former chief executive officer of Nodality Inc. and a
founding partner of New Leaf Venture Partners. The addition
increased Bolt’s board to eight members.
- Published data in Nature
Cancer highlighting proof of concept for Boltbody
ISAC platform to eliminate tumors following systemic administration
– In December 2020, Bolt announced the publication of a
manuscript in Nature Cancer highlighting the development and use of
Boltbody™ ISACs for the treatment of HER2-expressing tumors in
preclinical models. The data indicate that Boltbody ISACs activate
the innate and adaptive immune systems, ultimately resulting in
complete tumor regressions in multiple tumor models and durable
anti-tumor immunity. ISAC-mediated immunological memory extended
beyond the target antigen as ISAC-treated mice were protected from
re-challenge with the parental tumor lacking HER2 expression.
- Completed an oversubscribed $93.5 million Series C
financing with notable crossover investors – In July 2020
and January 2021, the Company raised funding to support BDC-1001
and continued development of the Boltbody ISAC platform and Bolt’s
pipeline of immuno-oncology programs. Sofinnova Investments led the
investment, which included notable crossover investors RA Capital
Management, Surveyor Capital (a Citadel Company), Rock Springs
Capital and Samsara BioCapital.
Upcoming Events
- Bolt’s Chief Scientific Officer David Dornan, Ph.D. will
present a talk on BDC-1001 as part of “New Drugs on the Horizon:
Part 2” at the American Association for Cancer Research (AACR)
Virtual Annual Meeting on Saturday, April 10, 2021, from 4:00 PM -
5:45 PM ET.
- Manish R. Sharma, M.D. of START Midwest, a principal
investigator in Bolt’s ongoing BDC-1001 Phase 1/2 trial, will
present a trial-in-progress e-poster entitled “CT218 - Phase 1/2
study of a novel HER2 targeting TLR7/8 immune-stimulating antibody
conjugate (ISAC), BDC-1001” in the session “PO.CT08.01 - Phase I
Clinical Trials in Progress” at AACR on Saturday, April 10, 2021,
from 8:30 AM - 11:59 PM ET.
- Bolt’s CEO, Randall Schatzman, Ph.D., will present a corporate
overview at the virtual 20th Annual Needham Virtual Healthcare
Conference on Thursday, April 15, 2021 at 10:15 AM ET.
Fourth Quarter and Full Year 2020 Financial
Results
Cash Position – Cash, cash equivalents, and
marketable securities were $22.8 million as of December 31, 2020,
as compared to $34.8 million as of December 31, 2019. Total cash,
cash equivalents, and marketable securities at December 31, 2020
does not include total net proceeds of approximately $293.6 million
from Bolt’s C-2 convertible preferred stock offering in January
2021 and its IPO in February 2021. Bolt expects its cash balance to
fund operations into 2023, through achievement of key milestone for
the BDC-1001 and BDC-2034 programs.
Research and Development (R&D) Expenses –
R&D expenses were $14.9 million for the quarter and $40.4
million for the full year ended December 31, 2020, compared to $7.4
million and $26.0 million for the same quarter and year in 2019.
The increase in R&D spending from 2019 to 2020 is due primarily
to the 2020 start of Bolt’s Phase 1/2 clinical trial for BDC-1001,
increased manufacturing of BDC-1001 to support the clinical trial
and additional hiring.
General and Administrative (G&A) Expenses –
G&A expenses were $2.1 million for the quarter and $9.1 million
for the full year ended December 31, 2020, compared to $2.1 million
and $5.2 million for the same quarter and year in 2019. The
increase in G&A spending from 2019 to 2020 is due primarily to
an increase in accounting and legal fees associated with IPO
preparation and additional hiring to support operations as a public
company.
Loss from Operations – Loss from operations was
$16.9 million for the quarter and $49.2 million for the full year
ended December 31, 2020 compared to $9.5 million and $31.0 million
for the same quarter and year in 2019.
About Bolt Biotherapeutics, Inc.
Bolt Biotherapeutics, Inc. is a clinical-stage immuno-oncology
company developing tumor-targeted therapies that leverage the power
of the innate and adaptive immune systems. Bolt’s proprietary
Boltbody™ Immune-stimulating Antibody Conjugate (ISAC) approach
combines an antibody that targets a tumor antigen with an immune
stimulant that triggers an innate and adaptive immune response in
the tumor microenvironment. These systemically-delivered Boltbody
ISACs are designed to target tumor cells for elimination by myeloid
cells, which are then activated and recruit the adaptive immune
system in the anti-tumor response. 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 with a
non-cleavable linker to one of Bolt’s proprietary TLR7/8 agonists
for the treatment of patients with HER2-expressing solid tumors.
Bolt is also advancing BDC-2034, a Boltbody ISAC targeting CEA, and
a pipeline of other immuno-oncology products.
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 enrollment
for our Phase 1/2 trial for BDC-1001 for the treatment of patients
with HER2-expressing solid tumors, the timing of our Phase 2 dose
expansion part and the combination with an anti-PD-1 antibody part,
the timing that Boltbody ISAC BDC-2034 will enter clinical trials,
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 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. |
STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
(in thousands, except share and per share
amounts) |
|
|
For the three months ended |
|
For the years ended |
|
December 31, |
|
December 31, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Collaboration Revenue |
$ |
— |
|
|
$ |
65 |
|
|
$ |
231 |
|
|
$ |
215 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
14,864 |
|
|
|
7,435 |
|
|
|
40,357 |
|
|
|
26,002 |
|
General and administrative |
|
2,058 |
|
|
|
2,137 |
|
|
|
9,056 |
|
|
|
5,182 |
|
Total operating expense |
|
16,922 |
|
|
|
9,572 |
|
|
|
49,413 |
|
|
|
31,184 |
|
Loss from operations |
|
(16,922 |
) |
|
|
(9,507 |
) |
|
|
(49,182 |
) |
|
|
(30,969 |
) |
Other income (expense),
net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income, net |
|
12 |
|
|
|
145 |
|
|
|
199 |
|
|
|
524 |
|
Change in fair value of preferred stock right liability |
|
(14,125 |
) |
|
|
— |
|
|
|
(11,745 |
) |
|
|
(42 |
) |
Total other income (expense),
net |
|
(14,113 |
) |
|
|
145 |
|
|
|
(11,546 |
) |
|
|
482 |
|
Net loss and comprehensive
loss |
$ |
(31,035 |
) |
|
$ |
(9,362 |
) |
|
$ |
(60,728 |
) |
|
$ |
(30,487 |
) |
Net loss per share, basic and
diluted |
$ |
(14.58 |
) |
|
$ |
(4.55 |
) |
|
$ |
(28.89 |
) |
|
$ |
(15.29 |
) |
Weighted-average shares
outstanding, basic and diluted |
|
2,129,133 |
|
|
|
2,056,459 |
|
|
|
2,102,328 |
|
|
|
1,993,477 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
BOLT BIOTHERAPEUTICS, INC. |
BALANCE SHEETS |
(in thousands, except share and per share
amounts) |
|
|
December 31, |
|
2020 |
|
2019 |
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
5,542 |
|
|
$ |
34,826 |
|
Short-term investments |
|
17,296 |
|
|
|
— |
|
Prepaid and other current assets |
|
2,523 |
|
|
|
1,074 |
|
Total current assets |
|
25,361 |
|
|
|
35,900 |
|
Property and equipment,
net |
|
4,083 |
|
|
|
1,387 |
|
Operating lease right-of-use
asset |
|
12,267 |
|
|
|
10,079 |
|
Finance lease right-of-use
asset |
|
34 |
|
|
|
51 |
|
Restricted cash |
|
1,565 |
|
|
|
584 |
|
Deferred offering costs |
|
2,357 |
|
|
|
— |
|
Other assets |
|
875 |
|
|
|
446 |
|
Total assets |
$ |
46,542 |
|
|
$ |
48,447 |
|
Liabilities,
Convertible Preferred Stock and Stockholders’ Equity
(Deficit) |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
$ |
1,598 |
|
|
$ |
2,095 |
|
Accrued expenses and other current liabilities |
|
6,663 |
|
|
|
2,866 |
|
Deferred revenue |
|
1,502 |
|
|
|
599 |
|
Operating lease liabilities |
|
1,501 |
|
|
|
3,096 |
|
Total current liabilities |
|
11,264 |
|
|
|
8,656 |
|
Operating lease liabilities,
net of current portion |
|
9,376 |
|
|
|
7,089 |
|
Deferred revenue |
|
— |
|
|
|
972 |
|
Convertible preferred stock
purchase right liability, non-current |
|
25,224 |
|
|
|
— |
|
Other Long-term
liabilities |
|
329 |
|
|
|
71 |
|
Total liabilities |
|
46,193 |
|
|
|
16,788 |
|
Convertible preferred
stock |
|
105,296 |
|
|
|
77,505 |
|
Stockholders’ equity
(deficit) |
|
|
|
|
|
|
Common stock |
|
— |
|
|
|
— |
|
Additional paid-in
capital |
|
3,452 |
|
|
|
1,825 |
|
Accumulated deficit |
|
(108,399 |
) |
|
|
(47,671 |
) |
|
|
|
|
|
|
|
Total stockholders’ equity (deficit) |
|
(104,947 |
) |
|
|
(45,846 |
) |
Total liabilities. convertible
preferred stock and stockholders’ equity (deficit) |
$ |
46,542 |
|
|
$ |
48,447 |
|
|
|
|
|
|
|
|
|
BOLT BIOTHERAPEUTICS, INC. |
STATEMENTS OF CASH FLOWS |
(in thousands) |
|
|
Years Ended December 31, |
|
2020 |
|
2019 |
Cash flows from operating activities |
|
|
|
|
|
|
|
Net loss |
$ |
(60,728 |
) |
|
$ |
(30,487 |
) |
Adjustments to reconcile net
loss to net cash used in operating activities: |
|
|
|
|
|
|
|
Depreciation and amortization |
|
611 |
|
|
|
335 |
|
Stock-based compensation |
|
1,420 |
|
|
|
508 |
|
Accretion of premium/discount on short-term investments |
|
34 |
|
|
|
— |
|
Change in fair value of convertible preferred stock purchase right
liabilities |
|
11,745 |
|
|
|
42 |
|
Non-cash lease expense |
|
1,893 |
|
|
|
994 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
Prepaid expenses and other assets |
|
(1,878 |
) |
|
|
(620 |
) |
Accounts payable and accrued expenses |
|
2,882 |
|
|
|
2,121 |
|
Operating lease liabilities |
|
(3,389 |
) |
|
|
(823 |
) |
Deferred revenue |
|
(69 |
) |
|
|
1,571 |
|
Other long-term liabilities |
|
171 |
|
|
|
16 |
|
Net cash used in operating
activities |
|
(47,308 |
) |
|
|
(26,343 |
) |
Cash flows from
investing activities |
|
|
|
|
|
|
|
Purchase of property and
equipment |
|
(3,262 |
) |
|
|
(508 |
) |
Purchases of short-term
investments |
|
(33,229 |
) |
|
|
— |
|
Maturities of short-term
investments |
|
15,899 |
|
|
|
— |
|
Net cash used in investing
activities |
|
(20,592 |
) |
|
|
(508 |
) |
Cash flows from
financing activities |
|
|
|
|
|
|
|
Repayments of financing lease
obligations |
|
— |
|
|
|
(40 |
) |
Proceeds from issuance of
convertible preferred stock, purchase rights and warrants, net of
issuance costs |
|
41,270 |
|
|
|
48,595 |
|
Payments of deferred offering
costs |
|
(1,967 |
) |
|
|
— |
|
Proceeds from issuance of
common stock and warrants |
|
294 |
|
|
|
72 |
|
Net cash provided by financing
activities |
|
39,597 |
|
|
|
48,627 |
|
Net (decrease) increase in
cash, cash equivalents and restricted cash |
|
(28,303 |
) |
|
|
21,776 |
|
Cash, cash equivalents and
restricted cash at beginning of year |
|
35,410 |
|
|
|
13,634 |
|
Cash, cash equivalents and
restricted cash at end of year |
$ |
7,107 |
|
|
$ |
35,410 |
|
Reconciliation of
cash, cash equivalents and restricted cash: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
5,542 |
|
|
$ |
34,826 |
|
Restricted cash |
|
1,565 |
|
|
|
584 |
|
Total cash, cash equivalents and restricted cash |
$ |
7,107 |
|
|
$ |
35,410 |
|
|
|
|
|
|
|
|
|
Media Contacts:
Maggie Beller or David SchullRusso Partners,
LLC646-942-5631maggie.beller@russopartnersllc.comdavid.schull@russopartnersllc.com
Investor Relations Contact:
Sarah McCabeStern Investor Relations,
Inc.212-362-1200sarah.mccabe@sternir.com
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