Full Press Release Details
Bolt Biotherapeutics Reports Fourth Quarter and Full Year 2020 Financial Results and Provides Business
- Upsized IPO in February 2021 raised $264.5 million in gross proceeds plus Series C raised $93.5 million
a total of $358 million in recent fundraising
- Advanced first-in-class Boltbody ISAC into the
clinic in 2020 and continued to expand pipeline of pioneering
immuno-oncology assets
- Reported positive preliminary data from first 20 patients treated with the HER2-targeting Boltbody ISAC
BDC-1001 in ongoing Phase 1/2 clinical trial in early 2021; monotherapy dose
expansion and anti-PD-1
combination parts of study expected to start in 2H, 2021
REDWOOD CITY, CA, March 31, 2021 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
Recent Business Highlights and Anticipated Milestones
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
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.
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 December 31, | For the years ended 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.
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
| 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 |
Maggie Beller or David Schull
Stern Investor Relations, Inc.