Bolt Biotherapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Business Update
03/29/2023 - 04:15 PM
Positive topline data from BDC-1001 dose-escalation clinical study validates the ability of the Boltbody™ ISAC platform to generate anti-tumor activity with acceptable safety BDC-1001 advances into a focused Phase 2 program commencing in 2023: a trial as monotherapy and in combination with nivolumab in colorectal, endometrial, and gastroesophageal cancers; and a second trial in breast cancer studying monotherapy and combination with pertuzumab (Perjeta® ) BDC-3042 expected to enter clinic in 2023; upcoming presentation at AACR 2023 Cash balance of $192.8 million anticipated to fund key milestones through 2025 REDWOOD CITY, Calif., March 29, 2023 (GLOBE NEWSWIRE) -- Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, today reported financial results for the fourth quarter and full year ended December 31, 2022, and provided a business update.
“We are pleased to be entering into an agreement with Roche to supply pertuzumab in support of a new combination study with BDC-1001 and we look forward to investigating the impact of this combination in patients with HER2-positive metastatic breast cancer, while we continue to investigate BDC-1001 as monotherapy and work with our partner Bristol Myers Squibb to explore the combination with nivolumab. The progress in developing new immunotherapies in both our proprietary and partnered research programs demonstrates the potential of myeloid biology to provide important new treatment options to patients with cancer.”
Recent Highlights and Anticipated Milestones
Topline BDC-1001 Phase 1 dose-escalation results – Topline data from a multi-center, multi-dose Phase 1 clinical trial evaluating BDC-1001 as a single agent and in combination with nivolumab supports selection of a recommended phase 2 dose (RP2D) and initiation of a Phase 2 clinical program including two studies in four tumor types.Phase 2 BDC-1001 studies planned to initiate in 2023 – Clinical trials will include patients with HER2-positive breast, colorectal, endometrial, and gastroesophageal cancers at clinical sites in the U.S., multiple European countries, and South Korea evaluating BDC-1001 as monotherapy, in combination with pertuzumab, and separately, in combination with nivolumab.BDC-3042 to enter the clinic in 2023 – Investigational New Drug (IND)-enabling activities for a Phase 1 trial for BDC-3042 are proceeding on track. BDC-3042 is an agonistic antibody targeting Dectin-2, an immune-activating receptor expressed by TAMs in solid tumors. Preclinical studies demonstrate the ability of Dectin-2 agonistic antibodies to reprogram tumor-associated macrophages and drive anti-tumor activity.Continued progress with Boltbody™ ISAC collaborations – Collaborations with Genmab and Innovent developing next-generation Boltbody ISACs continue to progress. Both collaborations are exploring proprietary linker-payloads from the Boltbody ISAC platform, combining with Genmab’s proprietary bispecific antibodies in one collaboration and with Innovent’s proprietary antibodies in the other.Strengthened Bolt's Board of Directors with appointment of Laura Berner – In December 2022, Laura Berner joined the Bolt Board of Directors. Ms. Berner brings extensive biopharmaceutical industry experience, having executed more than 50 transactions including research collaborations and product co-development and co-promotion partnerships. She currently serves as the Chief Operating Officer at TRexBio and has held multiple leadership positions spanning corporate strategy, business development, investor relations, and law.Cash, cash equivalents, and marketable securities were $192.8 million as of December 31, 2022 – Cash on hand, coupled with growing collaboration revenues, is expected to fund multiple key milestones and operations through 2025.Upcoming Events
BDC-3042 abstract accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting 2023 in Orlando, Fla. Title: Targeting tumor-associated macrophages to enhance anti-tumor immunity with the Dectin-2 agonistic antibodyPoster Board Number: 11Abstract Presentation Number: 2964Presenter: Justin A. Kenkel, Ph.D.Details: Monday, April 17, 2023, 1:30 p.m. – 5:00 p.m. EDTLocation: Orange County Convention Center, Section 24Fourth Quarter and Full Year 2022 Financial Results
Collaboration Revenue – Collaboration revenue was $1.4 million for the quarter and $5.7 million for the full year ended December 31, 2022, compared to $0.5 million and $1.3 million for the same quarter and year in 2021. The collaboration with Genmab exploring Boltbody ISACs using Genmab’s proprietary bispecific antibodies accounted for $4.2 million in revenue for 2022 and the collaboration with Innovent exploring Boltbody ISACs using Innovent’s proprietary antibodies accounted for $1.5 million in revenue for 2022. Research and Development (R&D) Expenses – R&D expenses were $16.8 million for the quarter and $73.1 million for the full year ended December 31, 2022, compared to $22.5 million and $75.7 million for the same quarter and year in 2021. The decrease in R&D expenses was due to lower manufacturing expenses related to the timing of batch production of our product candidates, offset by higher clinical expenses related to the ongoing BDC-1001 clinical trial due to increase in patient activities. General and Administrative (G&A) Expenses – G&A expenses were $5.6 million for the quarter and $22.9 million for the full year ended December 31, 2022, compared to $5.1 million and $18.4 million for the same quarter and year in 2021. The increase in G&A expenses was due to higher personnel-related expenses due to an increase in headcount and higher office and facility-related expenses, offset by lower consulting and professional services expenses. Loss from Operations – Loss from operations was $21.0 million for the quarter and $90.3 million for the full year ended December 31, 2022, compared to $27.1 million and $92.8 million for the same quarter and year in 2021.About the Boltbody™ Immune-Stimulating Antibody Conjugate (ISAC) Platform
About Bolt Biotherapeutics, Inc. https://www.boltbio.com/
Forward-Looking Statements ® ), our ability to fund our clinical programs and the sufficiency of our cash, cash equivalents, and marketable securities, expectations for growing collaboration revenues, 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,” “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 .
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BOLT BIOTHERAPEUTICS, INC. STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited, in thousands, except share and per share amounts) For The Three Months Ended December 31, Years Ended December 31, 2022 2021 2022 2021 Collaboration revenue $ 1,411 $ 508 $ 5,729 $ 1,260 Operating expenses: Research and development 16,845 22,484 73,123 75,655 General and administrative 5,606 5,099 22,927 18,393 Total operating expense 22,451 27,583 96,050 94,048 Loss from operations (21,040 ) (27,075 ) (90,321 ) (92,788 ) Other income (expense), net Interest income 1,043 (82 ) 2,223 281 Change in fair value of convertible preferred stock purchase right liability — — — (6,084 ) Total other income (expense), net 1,043 (82 ) 2,223 (5,803 ) Net loss (19,997 ) (27,157 ) (88,098 ) (98,591 ) Net unrealized loss on marketable securities 790 (283 ) (598 ) (321 ) Comprehensive loss $ (19,207 ) $ (27,440 ) $ (88,696 ) $ (98,912 ) Net loss per share, basic and diluted $ (0.53 ) $ (0.73 ) $ (2.36 ) $ (2.97 ) Weighted-average shares outstanding, basic and diluted 37,552,208 37,269,511 37,358,425 33,196,712
BOLT BIOTHERAPEUTICS, INC. BALANCE SHEETS (Unaudited, in thousands) December 31, 2022 2021 Assets Current assets: Cash and cash equivalents $ 9,244 $ 27,383 Short-term investments 159,644 158,836 Prepaid expenses and other current assets 3,858 2,941 Total current assets 172,746 189,160 Property and equipment, net 6,453 6,158 Operating lease right-of-use assets 22,072 24,445 Restricted cash 1,565 1,565 Long-term investments 23,943 85,348 Other assets 1,028 1,042 Total assets $ 227,807 $ 307,718 Liabilities and stockholders' equity Current liabilities: Accounts payable $ 3,594 $ 3,574 Accrued expenses and other current liabilities 15,140 12,384 Deferred revenue 1,993 2,869 Operating lease liabilities 2,391 2,501 Total current liabilities 23,118 21,328 Operating lease liabilities, net of current portion 20,220 21,854 Deferred revenue, non-current 12,921 14,207 Other long-term liabilities 42 210 Total liabilities 56,301 57,599 Commitments and contingencies Stockholders' equity: Preferred stock — — Common stock — — Additional paid-in capital 467,513 457,430 Accumulated other comprehensive loss (919 ) (321 ) Accumulated deficit (295,088 ) (206,990 ) Total stockholders' equity 171,506 250,119 Total liabilities, convertible preferred stock, and stockholders' equity $ 227,807 $ 307,718
BOLT BIOTHERAPEUTICS, INC. STATEMENTS OF CASH FLOWS (Unaudited, in thousands) Years Ended December 31, 2022 2021 CASH FLOWS FROM OPERATING ACTIVITIES: Net loss $ (88,098 ) $ (98,591 ) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization 1,666 1,193 Stock-based compensation expense 9,576 8,500 Accretion of premium/discount on short-term investments 184 2,654 Loss on disposal of property and equipment — 108 Change in fair value of convertible preferred stock purchase right liability — 6,084 Non-cash lease expense 3,225 2,479 Changes in operating assets and liabilities: Prepaid expenses and other assets (903 ) (568 ) Accounts payable and accrued expenses 2,768 6,676 Operating lease liabilities (2,596 ) (1,179 ) Deferred revenue (2,162 ) 15,574 Other long-term liabilities (164 ) 4 Net cash used in operating activities (76,504 ) (57,066 ) CASH FLOWS FROM INVESTING ACTIVITIES: Purchase of property and equipment (1,953 ) (2,338 ) Purchases of marketable securities (180,704 ) (313,375 ) Maturities of marketable securities 240,519 83,512 Net cash provided by (used in) investing activities 57,862 (232,201 ) CASH FLOWS FROM FINANCING ACTIVITIES: Proceeds from issuance of preferred stock, net — 51,902 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 503 1,252 Payment of deferred offering cost — — Net cash provided by financing activities 503 311,108 NET INCREASE (DECREASE) IN CASH (18,139 ) 21,841 Cash, cash equivalents and restricted cash at beginning of year 28,948 7,107 Cash, cash equivalents and restricted cash at end of period $ 10,809 $ 28,948 Reconciliation of cash, cash equivalents and restricted cash: Cash and cash equivalents $ 9,244 $ 27,383 Restricted cash 1,565 1,565 Total cash, cash equivalents and restricted cash $ 10,809 $ 28,948 Supplemental schedule of non-cash investing and financing activities: Vesting of unvested issued common stock $ 4 $ 123 Purchases of property and equipment included in accounts payable and accrued liabilities $ 8 $ 1,021 Deferred offering costs in accounts payable and accrued liabilities $ 102 $ — Right of use assets obtained in exchange for operating lease obligations $ 852 $ 14,657
Investor Relations and Media Contacts: kbergman@boltbio.com
Sarah McCabe sarah.mccabe@sternir.com
David Melamed david.melamed@russopartnersllc.com
