BOLT on Nasdaq
Bolt Biotherapeutics, Inc.
Bolt Biotherapeutics, Inc. is an American pharmaceutical preparations company based in Redwood City.2
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Last updated Oct 21, 2026.
Overview
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- TickerBOLT on Nasdaq2
- IndustryPharmaceutical Preparations2
- HeadquartersRedwood City, United States2
- Incorporated inDE3
- Business address900 Chesapeake Drive, Redwood City, Ca 940633
- Filer category, Emerging growth company3
- Legal formCorporation2
- LEI254900W0P77PQ6B8OY502
- StatusActive2
- LEI statusLapsed (not renewed)2
- Registered addressc/o Incorporating Services, Ltd., 19901 Dover, United States2
- Registered withDivision of Corporations, Department of State, 56793532
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Key numbers, fiscal 2025
Where the money goes
Where each dollar of revenue went, fiscal 2025
- Research and development100¢$28.5M
Out of $7.7M in revenue.5 The company lost money this year.
Financial statements
| Fiscal year | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|
| Revenue | $231.0K6 | $1.3M7 | $5.7M8 | $7.9M9 | $7.7M5 | $7.7M5 | |
| Research and development | $40.4M6 | $75.7M7 | $73.1M8 | $61.5M9 | $57.5M5 | $28.5M5 | |
| Operating expenses | $94.0M7 | $96.0M8 | $84.1M9 | $80.7M5 | $43.8M5 | ||
| Operating income | -$49.2M6 | -$92.8M7 | -$90.3M8 | -$76.2M9 | -$73.0M5 | -$36.1M5 | |
| Income before tax | -$63.1M5 | -$33.4M5 | |||||
| Income tax | $06 | $07 | $08 | $09 | $05 | $05 | |
| Net income | -$60.7M6 | -$98.6M7 | -$88.1M8 | -$69.2M9 | -$63.1M5 | -$33.4M5 | |
| Earnings per share | -$2.977 | -$2.368 | -$1.839 | -$33.065 | -$17.855 | ||
| Earnings per share (diluted) | -$2.977 | -$2.368 | -$1.839 | -$33.065 | -$17.855 | ||
| Shares (weighted, basic) | 33.2M shares7 | 37.4M shares8 | 37.8M shares9 | 1.9M shares5 | 1.9M shares5 | ||
| Shares (weighted, diluted) | 33.2M shares7 | 37.4M shares8 | 37.8M shares9 | 1.9M shares5 | 1.9M shares5 |
| Fiscal year | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|
| Cash | $5.5M6 | $27.4M7 | $9.2M8 | $10.8M9 | $7.2M5 | $11.7M5 | |
| Current assets | $25.4M6 | $189.2M7 | $172.7M8 | $105.7M9 | $50.8M5 | $30.3M5 | |
| Property, plant and equipment | $6.2M7 | $6.5M8 | $5.0M9 | $3.1M5 | $1.2M5 | ||
| Total assets | $46.5M6 | $307.7M7 | $227.8M8 | $159.8M9 | $99.6M5 | $56.7M5 | |
| Accounts payable | $3.6M7 | $3.6M8 | $3.0M9 | $1.5M5 | $1.4M5 | ||
| Current liabilities | $11.3M6 | $21.3M7 | $23.1M8 | $20.5M9 | $15.9M5 | $8.4M5 | |
| Total liabilities | $46.2M6 | $57.6M7 | $56.3M8 | $47.0M9 | $42.4M5 | $30.2M5 | |
| Retained earnings | -$207.0M7 | -$295.1M8 | -$364.3M9 | -$427.4M5 | -$460.8M5 | ||
| Shareholders’ equity | -$45.8M6 | -$104.9M7 | $250.1M8 | $171.5M9 | $112.7M5 | $57.2M5 | $26.5M5 |
| Shares outstanding | 2.1M shares6 | 37.4M shares7 | 37.8M shares8 | 38.1M shares9 | 1.9M shares5 | 1.9M shares5 |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
| Fiscal year | 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 |
|---|---|---|---|---|---|---|---|
| Cash from operations | -$47.3M6 | -$57.1M7 | -$76.5M8 | -$69.5M9 | -$61.3M5 | -$39.9M5 | |
| Depreciation and amortization | $1.2M7 | $1.7M8 | $1.9M9 | $1.8M5 | $1.3M5 | ||
| Stock-based compensation | $8.5M7 | $9.6M8 | $9.2M9 | $7.4M5 | $2.8M5 | ||
| Capital spending | $3.3M6 | $2.3M7 | $2.0M8 | $206.0K9 | $41.0K5 | $72.0K5 | |
| Free cash flow | -$50.6M | -$59.4M | -$78.5M | -$69.7M | -$61.3M | -$39.9M | |
| Cash from investing | -$232.2M7 | $57.9M8 | $71.0M9 | $57.6M5 | $44.3M5 | ||
| Cash from financing | $311.1M7 | $503.0K8 | $253.0K9 | $108.0K5 | $19.0K5 |
Corporate structure
Bolt Biotherapeutics, Inc. sits at the top of its group. 2 entities, 2 countries on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Bolt Biotherapeutics, Inc.
- RENAISSANCE TECHNOLOGIES LLC Filed SCHEDULE 13G on Bolt Biotherapeutics, Inc., latest Aug 13, 2026
- Pivotal bioVenture Partners Fund I, L.P. Filed SCHEDULE 13D/A on Bolt Biotherapeutics, Inc., latest Feb 26, 2026 (3 filings since Feb 12, 2024)
- Vivo Panda Fund, L.P. Filed SCHEDULE 13G/A on Bolt Biotherapeutics, Inc., latest Feb 13, 2026
- TANG CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G/A on Bolt Biotherapeutics, Inc., latest Nov 14, 2025 (4 filings since May 15, 2025)
- CITADEL ADVISORS LLC Filed SC 13G/A on Bolt Biotherapeutics, Inc., latest Nov 14, 2024 (4 filings since Feb 14, 2022)
- TANG CAPITAL PARTNERS LP Filed SC 13G/A on Bolt Biotherapeutics, Inc., latest Feb 14, 2024 (2 filings since Apr 20, 2023)
- Vivo Capital VIII, LLC Filed SC 13G/A on Bolt Biotherapeutics, Inc., latest Feb 13, 2024
- MONTANOVA CAPITAL, LLC Filed SC 13G/A on Bolt Biotherapeutics, Inc., latest Feb 13, 2023 (2 filings since Nov 29, 2021)
- Novo Holdings A/S Filed SC 13D/A on Bolt Biotherapeutics, Inc., latest Jan 4, 2023 (5 filings since Nov 22, 2021)
- RA CAPITAL MANAGEMENT, L.P. Filed SC 13G/A on Bolt Biotherapeutics, Inc., latest May 16, 2022
- Bolt Biotherapeutics, Inc. Redwood City, California, United States
- Bolt Biotherapeutics Australia PTY LTD Subsidiary · Australia
Built from parent and subsidiary links from GLEIF, the Global Legal Entity Identifier Foundation (CC0); subsidiaries listed in Exhibit 21 of annual reports filed with the SEC; major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Bolt Biotherapeutics, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.
Property and equipment
| Item | Latest | A year before | Change |
|---|---|---|---|
| Property and equipment, before depreciation | $8.6M5 Dec 31, 2025 | $10.4M5 Dec 31, 2024 | −17.1% |
| Accumulated depreciation | $7.4M5 Dec 31, 2025 | $7.3M5 Dec 31, 2024 | +1.5% |
| Property and equipment, net | $1.2M5 Dec 31, 2025 | $3.1M5 Dec 31, 2024 | −60.3% |
| Operating-lease assets (leased space) | $19.2M5 Dec 31, 2025 | $21.8M5 Dec 31, 2024 | −11.6% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $11.7M5 Dec 31, 2025 | $7.2M5 Dec 31, 2024 | +62.4% |
| Marketable securities, current | $15.8M5 Dec 31, 2025 | $40.1M5 Dec 31, 2024 | −60.6% |
| Debt securities available for sale | $20.1M5 Dec 31, 2025 | $63.0M5 Dec 31, 2024 | −68.0% |
| Long-term investments | $4.3M5 Dec 31, 2025 | $22.9M5 Dec 31, 2024 | −81.0% |
Properties, in its own words
Our headquarters are located in Redwood City, California, where we lease space in two locations totaling approximately 72,000 square feet, of which we have subleased approximately 26,000 square feet to third parties. Our lease expires in 2031. We believe that our headquarters and other offices are adequate for our current needs.
Item 2 of the 10-K filed Mar 12, 2026.12
Leadership
Who has led Bolt Biotherapeutics, Inc., and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
Chief operating officer
- Chief executive officerWilliam P. Quinn Jul 24, 2024 to now13
- Chief executive officerRandall C. Schatzman Feb 4, 2021 to Mar 6, 202414
- PresidentWilliam P. Quinn Jul 24, 2024 to now13
- Chief financial officerWilliam P. Quinn Feb 4, 2021 to now15
- Chief operating officerGrant Yonehiro Jul 24, 2024 to now16
Board members and other officers (17)
- Principal Accounting OfficerSarah Nemec May 15, 2024 to now17
- Chief Scientific OfficerDavid Dornan Feb 4, 2021 to Feb 23, 202218
- Chief Medical OfficerEdith A. Perez Feb 4, 2021 to Mar 6, 202419
- Chief Business OfficerGrant Yonehiro Feb 4, 2021 to Mar 6, 202420
- Board memberWilliam P. Quinn Jul 24, 2024 to now13
- Board memberJakob Dupont Sep 6, 2024 to now21
- Board memberLaura Berner Dec 16, 2022 to now22
- Board memberEdgar Engleman Feb 4, 2021 to Dec 1, 202323
- Board memberJames Healy Feb 4, 2021 to Jun 14, 202424
- Board memberKathleen Laporte Feb 4, 2021 to now25
- Board memberMahendra Shah Feb 4, 2021 to Jun 14, 202426
- Board memberPeter Moldt Feb 4, 2021 to Feb 4, 202127
- Board memberRandall C. Schatzman Feb 4, 2021 to Mar 6, 202414
- Board memberRichard A. Miller Md. Feb 4, 2021 to Jun 14, 202328
- Board memberBrian O'Callaghan Nov 19, 2021 to now29
- Board memberFrank D. Lee Nov 19, 2021 to Jun 14, 202430
- Board memberNicole Onetto Dec 16, 2021 to now31
Subsidiaries and ownership
Subsidiaries (Exhibit 21)
- Bolt Biotherapeutics Australia PTY LTD Australia4
The subsidiaries the company lists in Exhibit 21 of its annual report, as filed.
Former names
- Bolt Therapeutics, Inc.May 7, 2015 to May 7, 20153
Timeline
- Oct 6, 20268-K Entered a material agreement32
- Aug 11, 20268-K Results of operations33
- Jun 11, 20268-K Shareholder vote34
- May 12, 20268-K Results of operations35
- Mar 12, 20268-K Results of operations36
- Nov 12, 20258-K Results of operations37
- Oct 2, 20258-K Exit or restructuring costs; Other events38
- Aug 14, 20258-K Results of operations39
- Jun 6, 20258-K Listing notice or transfer; Bylaws or fiscal year changed40
- Jun 4, 20258-K Other events41
- May 28, 20258-K Shareholder vote42
- May 12, 20258-K Results of operations43
- Jul 24, 2024New chief executive William P. Quinn becomes CEO13
- Feb 4, 2021New chief executive Randall C. Schatzman becomes CEO14
Calendar
Coming up
- Nov 11, 2026Reports results for the quarter ending Sep/2026 A year earlier it reported ($3.72) a share, on Nov 12, 2025.44
When it reported results
- Aug 11, 2026Reported quarterly or annual results33
- May 12, 2026Reported quarterly or annual results35
- Mar 12, 2026Reported quarterly or annual results36
- Nov 12, 2025Reported quarterly or annual results37
- Aug 14, 2025Reported quarterly or annual results39
- May 12, 2025Reported quarterly or annual results43
- Mar 24, 2025Reported quarterly or annual results45
- Nov 12, 2024Reported quarterly or annual results46
Drug trials and FDA: coming up
- May 2027Phase 1/2 trial readout expected Phase 1/2 trial of BDC-4182 in Gastric Cancer Adenocarcinoma Metastatic: primary completion expected May 2027 (ClinicalTrials.gov NCT06921837).47
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). Trials from ClinicalTrials.gov, as the sponsor registered them (expected dates are the sponsor's own and often move); approvals and advisory committee meetings from the FDA. The FDA does not publish its decision (PDUFA) dates. The full markets calendar
Filings
218 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 40 major events, 108 insider forms, 24 large holders, 26 other. The latest 20:
- Oct 6, 20268-K EDGAR
- Sep 21, 20264 EDGAR
- Sep 21, 20264 EDGAR
- Sep 21, 20264 EDGAR
- Aug 13, 2026SCHEDULE 13G EDGAR
- Aug 11, 202610-Q EDGAR
- Aug 11, 20268-K EDGAR
- Jun 11, 20264 EDGAR
- Jun 11, 20264 EDGAR
- Jun 11, 20264 EDGAR
- Jun 11, 20264 EDGAR
- Jun 11, 20264 EDGAR
- Jun 11, 20268-K EDGAR
- May 12, 202610-Q EDGAR
- May 12, 20268-K EDGAR
- Apr 28, 2026ARS EDGAR
- Apr 28, 2026DEFA14A EDGAR
- Apr 28, 2026DEF 14A EDGAR
- Mar 12, 2026S-8 EDGAR
- Mar 12, 202610-K EDGAR
The 218 filings since October 2021 can be filtered by form type and year here when JavaScript is on.
Every filing from the last five years, summarized. The full record is on SEC EDGAR.
Insider trades
49 open-market trades by officers, directors and large owners since October 2021: 29 buys and 20 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Sep 18, 2026 | Yonehiro GrantChief Operating Officer | Sale | 6,850 | $3.24 | $22.2K | Form 4 |
| Sep 18, 2026 | Nemec SarahSenior VP, Finance and PAO | Sale | 4,077 | $3.24 | $13.2K | Form 4 |
| Sep 18, 2026 | Quinn William P.President, CEO and CFO | Sale | 9,132 | $3.24 | $29.6K | Form 4 |
| Sep 17, 2026 | Yonehiro GrantChief Operating Officer | Sale | 4,909 | $3.32 | $16.3K | Form 4 |
| Sep 17, 2026 | Nemec SarahSenior VP, Finance and PAO | Sale | 2,922 | $3.32 | $9.7K | Form 4 |
| Sep 17, 2026 | Quinn William P.President, CEO and CFO | Sale | 6,545 | $3.32 | $21.7K | Form 4 |
| Sep 16, 2026 | Yonehiro GrantChief Operating Officer | Sale | 1,417 | $3.77 | $5.3K | Form 4 |
| Sep 16, 2026 | Nemec SarahSenior VP, Finance and PAO | Sale | 843 | $3.77 | $3.2K | Form 4 |
| Sep 16, 2026 | Quinn William P.President, CEO and CFO | Sale | 1,889 | $3.77 | $7.1K | Form 4 |
| Jun 5, 2026 | Nemec SarahSenior VP, Finance and PAO | Buy | 509 | $3.88 | $2.0K | Form 4 |
| Jun 5, 2026 | Quinn William P.President, CEO and CFO | Buy | 637 | $3.88 | $2.5K | Form 4 |
| Dec 5, 2025 | Quinn William P.President, CEO and CFO | Buy | 125 | $4.61 | $576 | Form 4 |
| Dec 5, 2025 | Nemec SarahSenior VP, Finance and PAO | Buy | 125 | $4.61 | $576 | Form 4 |
| Jun 6, 2025 | Nemec SarahSenior VP, Finance and PAO | Buy | 125 | $5.49 | $686 | Form 4 |
| Jun 6, 2025 | Quinn William P.President, CEO and CFO | Buy | 125 | $5.49 | $686 | Form 4 |
| Dec 16, 2024 | Nemec SarahSenior VP, Finance and PAO | Buy | 2,500 | $0.50 | $1.2K | Form 4 |
| Dec 16, 2024 | Quinn William P.President, CEO and CFO | Buy | 2,500 | $0.50 | $1.2K | Form 4 |
| Jun 6, 2024 | Nemec SarahSenior VP, Finance and PAO | Buy | 2,500 | $0.64 | $1.6K | Form 4 |
| Jun 6, 2024 | Quinn William P.President, CEO and CFO | Buy | 2,500 | $0.64 | $1.6K | Form 4 |
| Dec 12, 2023 | Quinn William P.President, CEO and CFO | Buy | 7,500 | $0.95 | $7.1K | Form 4 |
All 49 trades can be filtered by person here when JavaScript is on.
From Forms 4 filed with the SEC.
Major holders
Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.
- RENAISSANCE TECHNOLOGIES LLCSCHEDULE 13G, 1 filing Aug 13, 202648
- Pivotal bioVenture Partners Fund I, L.P.SCHEDULE 13D/A, 3 filings Feb 12, 2024 to Feb 26, 202649
- Vivo Panda Fund, L.P.SCHEDULE 13G/A, 1 filing Feb 13, 202650
- TANG CAPITAL MANAGEMENT LLCSCHEDULE 13G/A, 4 filings May 15, 2025 to Nov 14, 202551
- CITADEL ADVISORS LLCSC 13G/A, 4 filings Feb 14, 2022 to Nov 14, 202452
- TANG CAPITAL PARTNERS LPSC 13G/A, 2 filings Apr 20, 2023 to Feb 14, 202453
- Vivo Capital VIII, LLCSC 13G/A, 1 filing Feb 13, 202454
- MONTANOVA CAPITAL, LLCSC 13G/A, 2 filings Nov 29, 2021 to Feb 13, 202355
- Novo Holdings A/SSC 13D/A, 5 filings Nov 22, 2021 to Jan 4, 202356
- RA CAPITAL MANAGEMENT, L.P.SC 13G/A, 1 filing May 16, 202257
Executive pay
What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.
| Year | Executive | Age | Salary | Total pay |
|---|---|---|---|---|
| 2025 | William P. Quinn | 55 | $463.5K | $4.6M58 |
| 2025 | Grant Yonehiro | 62 | $463.5K | $4.0M58 |
| 2024 | PresidentChief Executive Officer and Chief Financial Officer | $453.6K | $1.2M58 | |
| 2024 | Chief Operating Officer | $443.1K | $948.4K58 |
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026. Change is in shares since the quarter before.
| Fund | Shares | Value | Share of the fund | Change |
|---|---|---|---|---|
| Sofinnova Investments, Inc. | 137,721 | $530.2K | 0.0% | No change |
| Renaissance Technologies LLC | 98,625 | $379.7K | 0.0% | +21,400 |
| Vivo Capital, LLC | 72,414 | $278.8K | 0.0% | No change |
| Citadel Advisors LLC | 56,903 | $219.1K | 0.0% | +46,794 |
| T3 Companies, LLC | 38,000 | $146.3K | 0.2% | No change |
| Board of Trustees of The Leland Stanford Junior University | 35,977 | $138.5K | 0.0% | No change |
| Pfizer Inc | 31,305 | $133.8K | 0.1% | No change |
| Lynx1 Capital Management LP | 30,800 | $118.6K | 0.0% | No change |
| Nano Cap New Millennium Growth Fund L P | 27,500 | $105.9K | 0.1% | No change |
| Geode Capital Management, LLC | 19,119 | $73.6K | 0.0% | −9,672 |
| Shay Capital LLC | 15,438 | $59.4K | 0.0% | +533 |
| BlackRock, Inc. | 9,711 | $37.4K | 0.0% | No change |
| Vanguard Capital Management LLC | 7,060 | $27.2K | 0.0% | No change |
| Nan Fung Group Holdings Ltd | 5,000 | $19.2K | 0.0% | −24,250 |
| Morgan Stanley | 3,145 | $12.1K | 0.0% | −44 |
| Vanguard Fiduciary Trust Co | 3,095 | $11.9K | 0.0% | No change |
| NewEdge Advisors, LLC | 2,530 | $9.7K | 0.0% | New |
| Tower Research Capital LLC (TRC) | 1,710 | $6.6K | 0.0% | +617 |
| UBS Group AG | 255 | $982 | 0.0% | −532 |
| SBI Securities Co., Ltd. | 130 | $501 | 0.0% | +120 |
| Jpmorgan Chase & Co | 42 | $165 | 0.0% | No change |
| Citigroup Inc | 41 | $158 | 0.0% | New |
| Barclays PLC | 6 | $23 | 0.0% | No change |
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Bolt Biotherapeutics, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARBolt Biotherapeutics, Inc.1
- CIK0001641281
- Employer ID (EIN)47-280463612
- Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company12
- Incorporated inDelaware12
- Fiscal year endsDecember 311
- Industry code (SIC)2834 Pharmaceutical Preparations1
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance1
- Business address900 Chesapeake Drive, Redwood City, CA 940631
- Phone650-665-92951
- Shares outstanding1,926,345 as of Aug 4, 202611
- Public float$7.3M as of Jun 30, 202512
- AuditorPricewaterhouseCoopers LLP, San Jose, California PCAOB ID 238; no auditor attestation of internal control over financial reporting12
- On EDGAR sinceMay 7, 20151
- Filings291 in all: 4 (110), 8-K (45), 3 (21), 10-Q (17), SC 13G/A (8), 5 (7), D (7), SC 13D/A (7)1
All 34 form types
10-K (6), DEF 14A (6), S-8 (6), DEFA14A (5), SC 13G (5), SCHEDULE 13G/A (5), ARS (4), CORRESP (4), SC 13D (3), UPLOAD (3), DRS/A (2), DRSLTR (2), EFFECT (2), S-1/A (2), SCHEDULE 13D/A (2), SEC STAFF LETTER (2), 424B4 (1), 424B5 (1), 8-A12B (1), CERT (1), DRS (1), PRE 14A (1), S-1 (1), S-1MEF (1), S-3 (1), SCHEDULE 13G (1)
- Latest filingsAnnual report (10-K) Mar 12, 2026
Quarterly report (10-Q) Aug 11, 2026
Proxy statement (DEF 14A) Apr 28, 2026
Latest 8-K (8-K) Oct 6, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common Stock, $0.00001 par value | BOLT | Nasdaq |
From the cover page of the 10-K filed Mar 12, 2026 (Section 12(b) of the Exchange Act).12
Risk factors and legal proceedings
The risks Bolt Biotherapeutics, Inc. names in Item 1A of its 10-K filed Mar 12, 2026: 63 risks under these headings, as written.12
- Risks Related to Our Financial Position and Need for Additional Capital
- We have a limited operating history and have incurred significant losses since inception, and we anticipate that we may continue to incur losses for the foreseeable future and may never achieve or maintain profitability.
- We will need substantial funding to pursue our business objectives. If we are unable to raise capital when needed or on terms favorable to us, we could be forced to delay, reduce or terminate our product development and other operations.
- Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish proprietary rights.
- International trade policies, including tariffs, sanctions and trade barriers may adversely affect our business, financial condition, results of operations and prospects.
- We might not be able to utilize a significant portion of our net operating loss, or NOL, carryforwards.
- Risks Related to the Development of Our Product Candidates
- If none of our product candidates, including those in our collaborations, obtain regulatory approval and are successfully commercialized in one or more indications, or we or our collaboration partners experience significant delays in doing so, we may never generate any product revenue or become profitable.
- Our discovery and development of product candidates based on our Boltbody ISAC (immune-stimulating antibody conjugate) approach are unproven, which makes it difficult to predict the time and cost of product candidate development, and we do not know whether we will be able to develop any products of commercial value, or if competing technological approaches will limit the commercial value of our product candidates or render our platform obsolete.
- We are currently developing, and in the future may develop, product candidates in combination with other therapies and that may expose us to additional risks.
- We may seek accelerated approval for some or all of our product candidates from the FDA, however, the FDA may disagree and may require completion of additional clinical trials before considering a Biologics License Application, or BLA, for review.
- Clinical trials are very expensive, time-consuming and difficult to design and implement, and involve uncertain outcomes. Furthermore, results of earlier preclinical studies and clinical trials may not be predictive of results of future preclinical studies or clinical trials.
The other 53 risks
- We may encounter substantial delays in our clinical trials or we may fail to demonstrate safety and efficacy to the satisfaction of applicable regulatory authorities.
- We may expend our limited resources to pursue a particular product candidate or indication and fail to capitalize on product candidates or indications that may be more profitable or for which there is a greater likelihood of success.
- If any of our product candidates receives marketing approval and we, or others, later discover that the drug is less effective than previously believed or causes undesirable side effects that were not previously identified, our ability to market the drug could be compromised.
- If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
- We may become exposed to costly and damaging liability claims, either when testing our product candidates in the clinic or at the commercial stage, and our product liability insurance may not cover all damages from such claims.
- Risks Related to Commercialization of Our Product Candidates
- We have never commercialized a product candidate and we may lack the necessary expertise, personnel and resources to successfully commercialize on our own or together with collaborators, any of our products that receive regulatory approval.
- We face substantial competition, which may result in others discovering, developing or commercializing products before or more successfully than we do.
- Even if any of our product candidates receive marketing approval, they may fail to achieve the degree of market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success.
- The successful commercialization of certain of our product candidates will depend in part on the extent to which governmental authorities and health insurers establish adequate coverage, reimbursement levels and pricing policies.
- Failure to obtain or maintain adequate coverage and reimbursement for our product candidates, if approved, could limit our ability to market those products and decrease our ability to generate revenue.
- Even if we receive marketing approval for any of our product candidates, we may not achieve market acceptance, which would limit the revenue that we can generate from sales of any of our approved product candidates.
- Even if we obtain regulatory approval for our product candidates, they will remain subject to ongoing regulatory oversight.
- If any of our product candidates are approved for marketing and commercialization and we are unable to establish sales and marketing capabilities or enter into agreements with third parties to sell and market our product candidates, we will be unable to successfully commercialize our product candidates if and when they are approved.
- Risks Related to Our Dependence on Third Parties
- We do not have our own manufacturing capabilities and rely on third parties to produce clinical and commercial supplies of BDC-4182 and our other current and future product candidates.
- We rely on third parties to conduct our preclinical studies and clinical trials and if these third parties perform in an unsatisfactory manner, our business could be substantially harmed.
- If we are not able to maintain our current collaborations and establish further collaborations, we may have to alter some of our future development and commercialization plans.
- Risks Related to Regulatory Compliance
- Enacted and future legislation may increase the difficulty and cost for us to obtain marketing approval of and commercialize our product candidates and affect the prices we may charge for such product candidates.
- Our business operations and current and future relationships with investigators, health care professionals, consultants, third-party payors and customers will be subject, directly or indirectly, to federal and state healthcare fraud and abuse laws, false claims laws, health information privacy and security laws and other healthcare laws and regulations. If we are unable to comply, or have not fully complied with such laws, we could face substantial penalties.
- We are subject to stringent and evolving U.S. and foreign laws, regulations, rules, industry standards, contractual obligations, policies and other obligations related to data privacy and security. Our actual or perceived failure to comply with privacy and data protection obligations could lead to government investigations or enforcement actions (which could include civil or criminal penalties), private litigation, reputational harm and/or adverse publicity and could negatively affect our operating results and business.
- Risks Related to Our Intellectual Property
- If we are unable to obtain, maintain and protect sufficient patent and other intellectual property rights for our product candidates and technology, or if the scope of patent and other intellectual property rights obtained is not sufficiently broad, we may not be able to compete effectively in our market.
- The patent protection we obtain for our product candidates and technology may be challenged or not sufficient to provide us with any competitive advantage.
- We are heavily dependent on licensed intellectual property. If we were to lose our rights to licensed intellectual property, we may not be able to continue developing or commercializing our product candidates, if approved. If we breach any of the agreements under which we license the use, development and commercialization rights to our product candidates or technology from third parties or, in certain cases, we fail to meet certain development deadlines, we could lose license rights that are important to our business.
- Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed.
- We may become involved in lawsuits to protect or enforce our patents or other intellectual property, which could be expensive, time-consuming and unsuccessful, and issued patents covering our technology and product candidates could be found invalid or unenforceable if challenged.
- We may not be able to protect our intellectual property rights throughout the world.
- We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent which might adversely affect our ability to develop and market our product candidates.
- If we are unable to obtain licenses from third parties on commercially reasonable terms or fail to comply with our obligations under such agreements, our business could be harmed.
- Patent terms may be inadequate to protect the competitive position of our product candidates for an adequate amount of time.
- Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our product candidates.
- Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated if we fail to comply with these requirements.
- Third parties may initiate legal proceedings alleging that we are infringing, misappropriating or otherwise violating their intellectual property rights, the outcome of which would be uncertain and could negatively impact the success of our business.
- We may be subject to claims by third parties asserting that we or our employees have infringed upon, misappropriated or otherwise violated their intellectual property rights, or claiming ownership of what we regard as our own intellectual property.
- Intellectual property litigation could cause us to spend substantial resources and distract our personnel from their normal responsibilities.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- We may not be able to protect and enforce our trademarks and trade names or build name recognition in our markets of interest thereby harming our competitive position.
- Intellectual property rights do not necessarily address all potential threats.
- Risks Related to Our Business Operations, Employee Matters and Managing Growth
- Our business, operations and clinical development plans and timelines and supply chain could be adversely affected by macroeconomic uncertainties, including pandemics, labor shortages, inflation and monetary supply shifts, and potential disruptions from major geopolitical conflicts, on the manufacturing, clinical trial and other business activities performed by us or by third parties with whom we conduct business, including our contract development and manufacturing organizations, or CDMOs, contract research organizations, or CROs, shippers and others.
- Our future success depends on our ability to retain executives, key employees, consultants and advisors and to attract, retain and motivate qualified personnel.
- We expect to expand our development and regulatory capabilities and potentially implement sales, marketing and distribution capabilities, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations.
- Our employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs and vendors may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements.
- Our international operations may expose us to business, regulatory, political, operational, financial, pricing and reimbursement risks associated with doing business outside of the United States.
- Our internal computer systems, or those used by our CROs or other contractors or consultants, may fail or experience security breaches or other unauthorized or improper access.
- Risks Related to Our Common Stock
- The trading price of the shares of our common stock may be volatile, and purchasers of our common stock could incur substantial losses.
- Unstable market and economic conditions may have serious adverse consequences on our business, financial condition and share price.
- If equity research analysts do not publish research or reports, or publish unfavorable research or reports about us, our business or our market, our stock price and trading volume could decline.
- A significant portion of our total outstanding common stock may be sold into the market in the near future. This could cause the market price of our common stock to drop significantly, even if our business is doing well.
- Anti-takeover provisions in our charter documents and under Delaware law could make an acquisition of our company more difficult, limit attempts by our stockholders to replace or remove our current management and limit the market price of our common stock.
- We will incur costs and demands upon our management as a result of complying with the laws and regulations affecting public companies in the United States, which may harm our business.
- We are an “emerging growth company” and a “smaller reporting company,” and as a result of the reduced reporting requirements applicable to “emerging growth companies” and “smaller reporting companies,” our common stock may be less attractive to investors.
- If we fail to maintain proper and effective internal control over financial reporting, our ability to produce accurate consolidated financial statements on a timely basis could be impaired.
- Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be your sole source of gains and you may never receive a return on your investment.
- Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware and the federal district courts of the United States of America are the exclusive forums for substantially all disputes
- between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
Legal proceedings
From time to time, we may become involved in legal proceedings arising in the ordinary course of our business. There are currently no claims or actions pending against us, the ultimate disposition of which we believe could have a material adverse effect on our results of operations, financial condition or cash flows. We incorporate by reference into this Item our disclosures made in Note 6 to our Consolidated Financial Statements.
The opening of Item 3, Legal Proceedings.12
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- 21SEC EDGARJakob Dupont, Board member
- 22SEC EDGARLaura Berner, Board member
- 23SEC EDGAREdgar Engleman, Board member
- 24SEC EDGARJames Healy, Board member
- 25SEC EDGARKathleen Laporte, Board member
- 26SEC EDGARMahendra Shah, Board member
- 27SEC EDGARPeter Moldt, Board member
- 28SEC EDGARRichard A. Miller Md., Board member
- 29SEC EDGARBrian O'Callaghan, Board member
- 30SEC EDGARFrank D. Lee, Board member
- 31SEC EDGARNicole Onetto, Board member
- 32SEC EDGAREntered a material agreement
- 33SEC EDGARResults of operations
- 34SEC EDGARShareholder vote
- 35SEC EDGARResults of operations
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- 41SEC EDGAROther events
- 42SEC EDGARShareholder vote
- 43SEC EDGARResults of operations
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