Overview
- TickerBOLD on Nasdaq1
- IndustryPharmaceutical Preparations1
- HeadquartersLa Jolla, California1
- Websiteboundlessbio.com
- Incorporated inDE3
- Business address11099 North Torrey Pines Road, Suite 150, La Jolla, Ca 920373
- Filer categoryNon-accelerated filer, Smaller reporting company, Emerging growth company3
- Legal formCorporation
Financials
From the company’s reports to the SEC. Every number links to the filing it came from.
Financial statements
Every line of the income statement as filed: the last 2 fiscal years, latest first.5
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Research and development | $44.8M | $55.3M |
| General and administrative | $18.7M | $18.0M |
| Total operating expenses | $63.6M | $73.3M |
| Loss from operations | -$63.6M | -$73.3M |
| Interest income | $5.4M | $7.9M |
| Other income (expense), net | -$2.0K | $12.0K |
| Total other income, net | $5.4M | $7.9M |
| Net loss | -$58.2M | -$65.4M |
| Unrealized gain (loss) on short-term investments | -$57.0K | $81.0K |
| Comprehensive loss | -$58.3M | -$65.3M |
| Net loss per share - basic | -$2.60 | -$3.85 |
| Net loss per share - diluted | -$2.60 | -$3.85 |
| Shares used in calculation, basic | 22.4M shares | 17.0M shares |
| Shares used in calculation, diluted | 22.4M shares | 17.0M shares |
No quarter-by-quarter statement was filed.
Every line of the balance sheet as filed: the last 3 fiscal years (annual) or 3 quarters (quarterly), latest first.5
| Period ending | 2025-12-31 | 2024-12-31 | 2024-03-31 |
|---|---|---|---|
| Cash and cash equivalents | $17.9M | $26.6M | |
| Short-term investments | $89.7M | $125.5M | |
| Prepaid expenses and other current assets | $2.0M | $2.3M | |
| Total current assets | $109.6M | $154.4M | |
| Property and equipment, net | $3.2M | $4.3M | |
| Right-of-use asset, net | $43.7M | $47.0M | |
| Restricted cash | $560.0K | $560.0K | |
| Other assets | $13.0K | $99.0K | |
| Total assets | $157.1M | $206.4M | |
| Accounts payable and accrued liabilities | $6.7M | $5.4M | |
| Accrued compensation | $2.6M | $2.8M | |
| Lease liabilities, current portion | $3.2M | ||
| Total current liabilities | $12.5M | $8.1M | |
| Lease liabilities, non-current | $45.9M | $47.6M | |
| Total liabilities | $58.4M | $55.8M | |
| Preferred stock, $0.0001 par value; 70,000 shares authorized and no shares issued and outstanding as of December 31, 2025 and December 31, 2024 | $0 | $0 | |
| Common stock, $0.0001 par value; 700,000 shares authorized, 22,407 shares issued and outstanding as of December 31, 2025; 700,000 shares authorized, 22,300 shares issued and outstanding as of December 31, 2024 | $2.0K | $2.0K | |
| Additional paid-in-capital | $358.3M | $352.0M | |
| Accumulated other comprehensive income | $64.0K | $121.0K | |
| Accumulated deficit | -$259.7M | -$201.5M | |
| Total stockholders' equity | $98.7M | $150.6M | |
| Total liabilities and stockholders' equity | $157.1M | $206.4M | |
| Preferred stock, par value | $0.00 | $0.00 | $0.00 |
| Preferred stock, shares authorized | 70.0M shares | 70.0M shares | 70.0M shares |
| Preferred stock, shares issued | 0 shares | 0 shares | |
| Preferred Stock, shares outstanding | 0 shares | 0 shares | |
| Common stock, par value | $0.00 | $0.00 | $0.00 |
| Common stock, shares authorized | 700.0M shares | 700.0M shares | 700.0M shares |
| Common stock shares issued | 22.4M shares | 22.3M shares | |
| Common stock, shares outstanding | 22.4M shares | 22.3M shares |
| Period ending | 2025-12-31 | 2024-12-31 | 2024-03-31 |
|---|---|---|---|
| Cash and cash equivalents | $17.9M | $26.6M | |
| Short-term investments | $89.7M | $125.5M | |
| Prepaid expenses and other current assets | $2.0M | $2.3M | |
| Total current assets | $109.6M | $154.4M | |
| Property and equipment, net | $3.2M | $4.3M | |
| Right-of-use asset, net | $43.7M | $47.0M | |
| Restricted cash | $560.0K | $560.0K | |
| Other assets | $13.0K | $99.0K | |
| Total assets | $157.1M | $206.4M | |
| Accounts payable and accrued liabilities | $6.7M | $5.4M | |
| Accrued compensation | $2.6M | $2.8M | |
| Lease liabilities, current portion | $3.2M | ||
| Total current liabilities | $12.5M | $8.1M | |
| Lease liabilities, non-current | $45.9M | $47.6M | |
| Total liabilities | $58.4M | $55.8M | |
| Preferred stock, $0.0001 par value; 70,000 shares authorized and no shares issued and outstanding as of December 31, 2025 and December 31, 2024 | $0 | $0 | |
| Common stock, $0.0001 par value; 700,000 shares authorized, 22,407 shares issued and outstanding as of December 31, 2025; 700,000 shares authorized, 22,300 shares issued and outstanding as of December 31, 2024 | $2.0K | $2.0K | |
| Additional paid-in-capital | $358.3M | $352.0M | |
| Accumulated other comprehensive income | $64.0K | $121.0K | |
| Accumulated deficit | -$259.7M | -$201.5M | |
| Total stockholders' equity | $98.7M | $150.6M | |
| Total liabilities and stockholders' equity | $157.1M | $206.4M | |
| Preferred stock, par value | $0.00 | $0.00 | $0.00 |
| Preferred stock, shares authorized | 70.0M shares | 70.0M shares | 70.0M shares |
| Preferred stock, shares issued | 0 shares | 0 shares | |
| Preferred Stock, shares outstanding | 0 shares | 0 shares | |
| Common stock, par value | $0.00 | $0.00 | $0.00 |
| Common stock, shares authorized | 700.0M shares | 700.0M shares | 700.0M shares |
| Common stock shares issued | 22.4M shares | 22.3M shares | |
| Common stock, shares outstanding | 22.4M shares | 22.3M shares |
Cash flow is reported year to date, not quarter by quarter, so there are no separate quarterly figures.
Every line of the cash flow as filed: the last 2 fiscal years, latest first.5
| Period ending | 2025-12-31 | 2024-12-31 |
|---|---|---|
| Net loss | -$58.2M | -$65.4M |
| Stock-based compensation | $6.1M | $7.5M |
| Depreciation and amortization | $1.3M | $1.1M |
| Accretion of investments, net | -$2.6M | -$5.1M |
| Non-cash lease expense | $3.3M | $2.6M |
| Other | $102.0K | |
| Prepaid expenses and other assets | $332.0K | -$302.0K |
| Accounts payable and accrued liabilities | $1.6M | $775.0K |
| Operating lease liabilities | $1.5M | -$2.2M |
| Net cash used in operating activities | -$46.7M | -$60.8M |
| Purchases of investments | -$174.9M | -$208.5M |
| Maturities of investments | $213.2M | $184.9M |
| Purchases of property and equipment | -$546.0K | -$2.5M |
| Net cash provided by (used in) investing activities | $37.8M | -$26.1M |
| Proceeds from the issuance of common stock from initial public offering, net of discounts | $93.0M | |
| Payments of common stock offering costs | -$3.3M | |
| Proceeds from the exercise of stock options | $62.0K | |
| Proceeds from issuance of common stock under the Employee Stock Purchase Plan | $141.0K | $110.0K |
| Net cash provided by financing activities | $141.0K | $89.8M |
| Net increase (decrease) in cash, cash equivalents, and restricted cash | -$8.7M | $2.9M |
| Change in unpaid common stock issuance costs | -$197.0K | |
| Addition to right-of-use assets obtained in exchange for lease obligation | $47.6M | |
| Decrease to right-of-use assets due to remeasurement of lease obligation | -$92.0K | |
| Vesting of early exercised stock options | $6.0K | |
| Unpaid property and equipment purchases | $400.0K |
No quarter-by-quarter statement was filed.
Corporate structure
Boundless Bio (United States) sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.
Major holders of Boundless Bio (United States)
- Zachary Hornby Filed SCHEDULE 13G on Boundless Bio (United States), latest Aug 27, 2026
- ADAR1 Capital Management, LLC Filed SCHEDULE 13G on Boundless Bio (United States), latest Aug 14, 2026
- CITADEL ADVISORS LLC Filed SCHEDULE 13G/A on Boundless Bio (United States), latest Aug 14, 2026 (2 filings since Dec 4, 2025)
- TANG CAPITAL MANAGEMENT LLC Filed SCHEDULE 13G on Boundless Bio (United States), latest Jun 29, 2026
- Nextech VI GP S.A.R.L. Filed SCHEDULE 13G/A on Boundless Bio (United States), latest Feb 17, 2026 (2 filings since Apr 12, 2024)
- FMR LLC Filed SCHEDULE 13G/A on Boundless Bio (United States), latest Feb 5, 2026 (2 filings since Apr 10, 2024)
- RA CAPITAL MANAGEMENT, L.P. Filed SCHEDULE 13G/A on Boundless Bio (United States), latest Aug 14, 2025 (2 filings since Apr 12, 2024)
- ARCH Venture Fund IX, L.P. Filed SC 13D on Boundless Bio (United States), latest Oct 29, 2024
- BAYER HEALTHCARE LLC Filed SC 13G on Boundless Bio (United States), latest Apr 9, 2024
- Boundless Bio (United States) La Jolla, California
Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.
What it owns
What Boundless Bio (United States) 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 | $8.2M5 Dec 31, 2025 | $8.0M5 Dec 31, 2024 | +1.8% |
| Accumulated depreciation | $5.0M5 Dec 31, 2025 | $3.7M5 Dec 31, 2024 | +33.7% |
| Property and equipment, net | $3.2M5 Dec 31, 2025 | $4.3M5 Dec 31, 2024 | −25.6% |
| Operating-lease assets (leased space) | $43.7M5 Dec 31, 2025 | $47.0M5 Dec 31, 2024 | −7.2% |
Investments
| Item | Latest | A year before | Change |
|---|---|---|---|
| Cash and cash equivalents | $17.9M5 Dec 31, 2025 | $26.6M5 Dec 31, 2024 | −32.8% |
| Marketable securities, current | $89.7M5 Dec 31, 2025 | $125.5M5 Dec 31, 2024 | −28.5% |
| Debt securities available for sale | $105.8M5 Dec 31, 2025 | $150.4M5 Dec 31, 2024 | −29.7% |
Properties, in its own words
Our corporate headquarters are currently located in San Diego, California, where we lease approximately 80,168 square feet of laboratory and office space pursuant to a lease that expires in October 2034. We believe our existing facilities are adequate to meet our current business requirements for the near term, and that additional space will be available on commercially reasonable terms, if required.
Item 2 of the 10-K filed Mar 9, 2026.8
Leadership
Who has led Boundless Bio (United States), and when. Pick a name to see everywhere that person has worked.
Chief executive
President
Chief financial officer
- Chief executive officerZachary Hornby Mar 27, 2024 to now9
- PresidentZachary Hornby Mar 27, 2024 to now9
- Chief financial officerJami Rubin Mar 27, 2024 to Aug 20, 202410
Board members and other officers (12)
- Chief Medical OfficerRobert Doebele Feb 3, 2025 to now11
- Chief Scientific OfficerChristian Hassig Mar 27, 2024 to now12
- OfficerJessica Oien Mar 27, 2024 to now13
- Chief Medical OfficerKlaus W. Wagner Mar 27, 2024 to Aug 20, 202414
- Chief Business OfficerNeil Abdollahian Mar 27, 2024 to Aug 20, 202415
- OfficerDavid A. Hinkle Oct 15, 2024 to now16
- Board memberJames Christensen Mar 27, 2024 to now17
- Board memberJennifer Lew Mar 27, 2024 to now18
- Board memberJonathan E. Lim Mar 27, 2024 to now19
- Board memberKristina Burow Mar 27, 2024 to now20
- Board memberNancy Whiting Mar 27, 2024 to now21
- Board memberZachary Hornby Mar 27, 2024 to now9
Named in SEC Form D filings
People the company listed in its private-offering notices.
Timeline
- Aug 28, 20268-K Entered a material agreement23
- Jun 23, 20268-K Entered a material agreement; Exit or restructuring costs; Unregistered sale of shares24
- Jun 17, 20268-K Shareholder vote25
- May 8, 20268-K Results of operations26
- Apr 13, 20268-K Ended a material agreement; New debt or obligation27
- Mar 9, 20268-K Results of operations; Executive or director change28
- Nov 5, 20258-K Results of operations29
- Aug 5, 20258-K Results of operations30
- Jun 23, 20258-K Shareholder vote31
- May 23, 20258-K Exit or restructuring costs; Other events32
- May 9, 20258-K Results of operations33
- Apr 1, 20258-K Entered a material agreement34
- Mar 27, 2024New chief executive Zachary Hornby becomes CEO9
- 2018Founded Founded1
Calendar
Coming up
- Nov 4, 2026Reports results for the quarter ending Sep/202635
When it reported results
- May 8, 2026Reported quarterly or annual results26
- Mar 9, 2026Reported quarterly or annual results28
- Nov 5, 2025Reported quarterly or annual results29
- Aug 5, 2025Reported quarterly or annual results30
- May 9, 2025Reported quarterly or annual results33
- Mar 27, 2025Reported quarterly or annual results36
- Nov 7, 2024Reported quarterly or annual results37
- Aug 12, 2024Reported quarterly or annual results38
Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar
Filings
151 filings to the SEC since October 2021: 2 annual reports, 8 quarterly reports, 20 major events, 73 insider forms, 13 large holders, 1 private raises, 34 other. The latest 20:
- Oct 8, 2026S-4 EDGAR
- Aug 31, 2026DRS EDGAR
- Aug 28, 2026425 EDGAR
- Aug 28, 20268-K EDGAR
- Aug 28, 20264 EDGAR
- Aug 27, 2026SCHEDULE 13G EDGAR
- Aug 14, 2026SCHEDULE 13G EDGAR
- Aug 14, 2026SCHEDULE 13G/A EDGAR
- Aug 7, 202610-Q EDGAR
- Jul 21, 20264 EDGAR
- Jul 16, 20264 EDGAR
- Jul 13, 20264 EDGAR
- Jul 8, 20264 EDGAR
- Jul 6, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
- Jul 6, 20264 STATEMENT OF CHANGES IN BENEFICIAL OWNERSHIP OF SECURITIES EDGAR
- Jul 2, 20264 EDGAR
- Jun 29, 2026SCHEDULE 13G EDGAR
- Jun 29, 20264 EDGAR
- Jun 29, 20263 EDGAR
- Jun 23, 2026425 EDGAR
The 151 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
25 open-market trades by officers, directors and large owners since October 2021: 22 buys and 3 sales. Grants, option exercises and gifts are left out.
| Date | Who | Trade | Shares | Price | Value | Filing |
|---|---|---|---|---|---|---|
| Aug 26, 2026 | TANG CAPITAL MANAGEMENT LLC10% owner | Sale | 18,300 | $2.97 | $54.4K | Form 4 |
| Jul 21, 2026 | TANG KEVIN10% owner | Buy | 2,975 | $2.44 | $7.3K | Form 4 |
| Jul 20, 2026 | TANG KEVIN10% owner | Buy | 1,623 | $2.44 | $4.0K | Form 4 |
| Jul 17, 2026 | TANG KEVIN10% owner | Buy | 265 | $2.44 | $647 | Form 4 |
| Jul 16, 2026 | TANG KEVIN10% owner | Buy | 18,491 | $2.44 | $45.1K | Form 4 |
| Jul 15, 2026 | TANG KEVIN10% owner | Buy | 1,600 | $2.44 | $3.9K | Form 4 |
| Jul 14, 2026 | TANG KEVIN10% owner | Buy | 43,878 | $2.43 | $106.6K | Form 4 |
| Jul 13, 2026 | TANG KEVIN10% owner | Buy | 48,211 | $2.42 | $116.7K | Form 4 |
| Jul 10, 2026 | TANG KEVIN10% owner | Buy | 43,367 | $2.43 | $105.4K | Form 4 |
| Jul 9, 2026 | TANG KEVIN10% owner | Buy | 7 | $2.48 | $17 | Form 4 |
| Jul 8, 2026 | TANG KEVIN10% owner | Buy | 14,338 | $2.46 | $35.3K | Form 4 |
| Jul 7, 2026 | TANG KEVIN10% owner | Buy | 15,810 | $2.48 | $39.2K | Form 4 |
| Jul 6, 2026 | TANG KEVIN10% owner | Buy | 27,062 | $2.49 | $67.4K | Form 4 |
| Jul 2, 2026 | TANG KEVIN10% owner | Buy | 9,821 | $2.49 | $24.5K | Form 4 |
| Jul 1, 2026 | TANG KEVIN10% owner | Buy | 71,612 | $2.49 | $178.3K | Form 4 |
| Jul 1, 2026 | GILLIS STEVEN10% owner | Sale | 16,000 | $2.49 | $39.8K | Form 4 |
| Jul 1, 2026 | ARCH Venture Partners IX, L.P.10% owner | Sale | 16,000 | $2.49 | $39.8K | Form 4 |
| Jun 30, 2026 | TANG KEVIN10% owner | Buy | 26,030 | $2.54 | $66.1K | Form 4 |
| Jun 29, 2026 | TANG KEVIN10% owner | Buy | 64,762 | $2.47 | $160.0K | Form 4 |
| Jun 26, 2026 | TANG KEVIN10% owner | Buy | 75,181 | $2.55 | $191.7K | Form 4 |
All 25 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.
- Zachary HornbySCHEDULE 13G, 1 filing Aug 27, 202639
- ADAR1 Capital Management, LLCSCHEDULE 13G, 1 filing Aug 14, 202640
- CITADEL ADVISORS LLCSCHEDULE 13G/A, 2 filings Dec 4, 2025 to Aug 14, 202641
- TANG CAPITAL MANAGEMENT LLCSCHEDULE 13G, 1 filing Jun 29, 202642
- Vi Gp S.a.r.l. NextechSCHEDULE 13G/A, 2 filings Apr 12, 2024 to Feb 17, 202643
- FMR LLCSCHEDULE 13G/A, 2 filings Apr 10, 2024 to Feb 5, 202644
- RA CAPITAL MANAGEMENT, L.P.SCHEDULE 13G/A, 2 filings Apr 12, 2024 to Aug 14, 202545
- ARCH Venture Fund IX, L.P.SC 13D, 1 filing Oct 29, 202446
- BAYER HEALTHCARE LLCSC 13G, 1 filing Apr 9, 202447
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 | Zachary D. Hornby | 47 | $638.0K | $1.6M48 |
| 2025 | Robert DoebeleM.D., Ph.D. | $458.5K | $978.3K48 | |
| 2025 | Christian HassigPh.D. | $478.3K | $875.4K48 | |
| 2024 | PresidentChief Executive Officer, and Director | $594.6K | $6.1M48 | |
| 2024 | Chief Scientific Officer | $453.1K | $2.2M48 |
Funding
Where the company's money came from, by calendar year: private offerings filed with the SEC, federal grants, loans, contracts and other assistance from USAspending.gov, and PPP loans from the SBA. Each bar links to the records below.
- Private raises (Form D) $100.0M
Figures by year
| Year | Private raises (Form D) | Total |
|---|---|---|
| 2023 | $100.0M | $100.0M |
Private raises
Private offerings the company reported to the SEC on Form D. The amount is what the latest filing says was sold so far, charted in the year of the first sale. Covers filings since Oct 1, 2021.
Held by these funds
The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 40. Change is in shares since the quarter before.
13F reports cover disclosed long positions in U.S. stocks only.
SEC filer profile
How Boundless Bio (United States) is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.
- Name on EDGARBoundless Bio, Inc.2
- CIK0001782303
- Employer ID (EIN)83-07513698
- Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company8
- Incorporated inDelaware8
- Fiscal year endsDecember 312
- Industry code (SIC)2834 Pharmaceutical Preparations2
- SEC reviewing officeOffice of Life Sciences, Division of Corporation Finance2
- Business address11099 North Torrey Pines Road, Suite 150, La Jolla, CA 920372
- Phone(858) 766-99122
- Shares outstanding22,747,985 as of Aug 5, 20267
- Public float$18.0M as of Jun 30, 20258
- AuditorKPMG LLP, San Diego, CA PCAOB ID 185; no auditor attestation of internal control over financial reporting8
- On EDGAR sinceMar 12, 20202
- Filings153 in all: 4 (54), 8-K (20), 3 (19), 10-Q (8), CORRESP (6), UPLOAD (5), SC 13G (4), SCHEDULE 13G (4)2
All 28 form types
SCHEDULE 13G/A (4), D (3), 10-K (2), 425 (2), ARS (2), DEF 14A (2), DEFA14A (2), DRS (2), DRS/A (2), EFFECT (2), 424B4 (1), 8-A12B (1), CERT (1), DRSLTR (1), S-1 (1), S-1/A (1), S-3 (1), S-4 (1), S-8 (1), SC 13D (1)
- Latest filingsAnnual report (10-K) Mar 9, 2026
Quarterly report (10-Q) Aug 7, 2026
Proxy statement (DEF 14A) Apr 28, 2026
Latest 8-K (8-K) Aug 28, 2026
Securities registered for trading
| Class | Symbol | Exchange |
|---|---|---|
| Common stock, par value $0.0001 per share | BOLD | Nasdaq Global Select Market |
From the cover page of the 10-K filed Mar 9, 2026 (Section 12(b) of the Exchange Act).8
Risk factors and legal proceedings
The risks Boundless Bio (United States) names in Item 1A of its 10-K filed Mar 9, 2026: 73 risks under these headings, as written.8
- Risks Related to Our Limited Operating History, Financial Position and Capital Requirements
- We have a limited operating history, have incurred significant operating losses since our inception, and expect to incur significant losses for the foreseeable future. We may never generate any revenue or become profitable or, if we achieve profitability, we may not be able to sustain it.
- We will require substantial additional capital to finance our operations, and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce, or terminate our ecDTx development programs, commercialization efforts, or other operations.
- Raising additional capital may cause dilution to our stockholders, restrict our operations, or require us to relinquish rights to our technologies or ecDTx.
- We occupy our corporate headquarters under a long-term non-cancellable lease which may limit our operating flexibility and could adversely affect our liquidity and results of operations.
- Risks Related to the Discovery, Development, and Regulatory Approval of Our ecDTx
- We are early in our development efforts and have only one ecDTx in development. If we are unable to successfully develop, obtain regulatory approval, and ultimately commercialize our ecDTx, or experience significant delays in doing so, our business will be materially harmed.
- Our approach to treating cancer with oncogene amplifications by developing ecDTx directed against ecDNA is novel and unproven, and we do not know whether we will be able to develop any products of commercial value, or if competing approaches will limit the commercial value of our ecDTx.
- Clinical and preclinical development involves a lengthy and expensive process with uncertain timelines and outcomes, and the results of preclinical studies and early clinical trials are not necessarily predictive of future results. Our ecDTx may not achieve favorable results in ongoing or future clinical trials or preclinical studies or receive regulatory approval on a timely basis, if at all.
- Any difficulties or delays in the commencement or completion, or the termination or suspension, of our current or planned clinical trials or preclinical studies could result in increased costs to us, delay or limit our ability to generate revenue, or adversely affect our commercial prospects.
- We may find it difficult to enroll patients in our clinical trials. If we encounter difficulties or delays enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected.
- Use of our ecDTx could be associated with side effects, adverse events, or other properties or safety risks, which could delay or preclude regulatory approval, cause us to suspend or discontinue clinical trials, cause us to abandon an ecDTx, limit the commercial profile of an approved label, or result in other significant negative consequences that could severely harm our business, financial condition, results of operations, and prospects.
The other 62 risks
- As an organization, we have never completed any clinical trials and may be unable to do so for our ecDTx.
- If we are unable to successfully identify predictive biomarkers to identify patient populations most likely to benefit from our ecDTx, or develop a diagnostic to enable patient selection for our ecDTx, or if we experience significant delays in doing so, we may not realize the full commercial potential of our ecDTx.
- We intend to develop our ecDTx in combination with other therapies, which exposes us to additional risks.
- We may expend our limited resources to pursue a particular ecDTx or a particular indication for an ecDTx and fail to capitalize on ecDTx or indications that may be more profitable or for which there is a greater likelihood of success.
- We may in the future conduct certain of our clinical trials for our ecDTx outside of the United States. However, the FDA and other foreign equivalents may not accept data from such trials, in which case our development plans will be delayed, which could materially harm our business.
- Interim, topline, and preliminary data from our clinical trials and preclinical studies that we announce or publish from time to time may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
- Changes in methods of ecDTx manufacturing or formulation may result in additional costs or delay.
- If we are required by the FDA or comparable foreign regulatory authority to obtain approval of a companion diagnostic test in connection with approval of our ecDTx, and we do not obtain, or face delays in obtaining, FDA or foreign approval of such companion diagnostic, we will not be able to commercialize our ecDTx, and our ability to generate revenue will be materially impaired.
- We may attempt to secure approval from the FDA through the use of the accelerated approval pathway. If we are unable to obtain such approval, we may be required to conduct additional clinical trials beyond those that we contemplate, which could increase the expense of obtaining, and delay the receipt of, necessary regulatory approvals. Even if we receive accelerated approval from the FDA, if our confirmatory trials do not verify clinical benefit, or if we do not comply with rigorous post-marketing requirements, the FDA may seek to withdraw any accelerated approval we have obtained.
- Disruptions at the FDA, the SEC, and other government agencies, including due to government shutdowns, other funding shortages, policy changes, leadership changes, layoffs or significant personnel turnover, or public health concerns, could impede development and potential marketing approval of our ecDTx and our ability to raise capital.
- Risks Related to Our Reliance on Third Parties
- We rely on third parties to conduct our clinical trials and preclinical studies. If these third parties do not successfully carry out their contractual duties, comply with applicable regulatory requirements, or meet expected deadlines, our ecDTx development programs and our ability to seek or obtain regulatory approval for or commercialize our ecDTx may be delayed.
- We rely on third parties for the manufacture of our ecDTx for clinical and preclinical development and expect to continue to do so for the foreseeable future. This reliance on third parties increases the risk that we will not have sufficient quantities of our ecDTx or products or such quantities at an acceptable cost, which could delay, prevent, or impair, our development or commercialization efforts.
- Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor or other third party will discover them or that our trade secrets will be misappropriated or disclosed.
- We may seek to enter into collaborations, licenses, and other similar arrangements and may not be successful in doing so, and even if we are, we may relinquish valuable rights and may not realize the benefits of such relationships.
- Risks Related to Commercialization of Our ecDTx
- Even if we receive regulatory approval for any ecDTx, we will be subject to ongoing regulatory obligations and continued regulatory review, which may result in significant additional expense.
- The FDA and other regulatory agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses.
- The commercial success of our ecDTx will depend upon the degree of market acceptance of such ecDTx by physicians, patients, healthcare payors, and others in the medical community.
- The successful commercialization of our ecDTx, if approved, will depend in part on the extent to which governmental authorities and health insurers establish coverage, adequate reimbursement levels, and favorable pricing policies. Failure to obtain or maintain coverage and adequate reimbursement for our ecDTx could limit our ability to market those products and decrease our ability to generate revenue.
- We face significant competition from entities that have developed or may develop product candidates for cancer, including companies developing novel treatments and technology platforms. If our competitors develop and commercialize their product candidates more rapidly than we do, or their technologies or their product candidates are more effective, safer, or less expensive than our ecDTx, our business and our ability to develop and successfully commercialize ecDTx may be adversely affected.
- The market opportunities for our ecDTx may be limited to patients who are ineligible for or have failed prior treatments and may be small or different from our estimates.
- We currently have no marketing and sales organization and have no experience as a company in commercializing products, and we may need to invest significant resources to develop these capabilities. If we are unable to establish marketing and sales capabilities or enter into agreements with third parties to market and sell our products, we may not be able to generate product revenue.
- Our future growth may depend, in part, on our ability to operate in foreign markets, where we would be subject to additional regulatory burdens and other risks and uncertainties.
- Risks Related to Our Business Operations and Industry
- Our operating results may fluctuate significantly, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
- We have a relatively small number of employees which may constrain our ability to accomplish our business objectives. Our long-term success is dependent on our ability to retain and attract highly qualified management and other clinical and scientific personnel.
- We may encounter difficulties in managing our growth and expanding our operations successfully.
- We are subject to various U.S. federal, state, and foreign healthcare laws and regulations, which could increase compliance costs, and our failure to comply with these laws and regulations could harm our reputation, subject us to significant fines and liability, or otherwise adversely affect our business.
- Current and future healthcare reform legislation or regulation may increase the difficulty and cost for us to obtain coverage for and commercialize our ecDTx and may adversely affect the prices we may set.
- If product liability lawsuits are brought against us, we may incur substantial liabilities and may be required to limit, delay, or cease commercialization of our ecDTx.
- Our insurance policies are expensive and protect us from only some business risks, which will leave us exposed to significant uninsured liabilities.
- We and our service providers may be subject to a variety of data protection, privacy, and security obligations, including laws, regulations, standards, and contractual provisions, which could increase compliance costs, and our actual or perceived failure to comply with such laws and obligations could subject us to potentially significant liability, fines, or penalties and otherwise harm our business.
- Our information technology systems, or those of any of our service providers, may fail or suffer security incidents and other disruptions, which could result in a material disruption of our ecDTx development programs, compromise sensitive information related to our business, or prevent us from accessing critical information, potentially exposing us to liability, or otherwise adversely affecting our business.
- Our business could be affected by litigation, government investigations, and enforcement actions.
- Our employees and independent contractors, including principal investigators, CROs, consultants, and vendors, may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- We may engage in strategic transactions that could impact our liquidity, increase our expenses, and present significant distractions to our management.
- Our ability to use net operating loss carryforwards and other tax attributes may be limited.
- Inflation could adversely affect our business and results of operation.
- Risks Related to Our Intellectual Property
- If we are unable to obtain, maintain, defend, and enforce patent or other intellectual property protection for our ecDTx, diagnostic, or technology, or if the scope of the patent or other intellectual property protection obtained is not sufficiently broad, our competitors or other third parties could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our ecDTx may be adversely affected.
- We may not be able to protect our intellectual property and proprietary rights throughout the world.
- Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
- Changes in patent laws or their interpretations could diminish the value of patents in general, thereby impairing our ability to protect our products.
- Issued patents covering our ecDTx could be found invalid or unenforceable if challenged in court or before administrative bodies in the United States or abroad.
- Patent terms may be inadequate to protect the competitive position of our ecDTx for an adequate amount of time.
- If we do not obtain patent term extension and equivalent extensions outside of the United States for our ecDTx, our business may be materially harmed.
- We may be subject to claims challenging the inventorship of our patents and other intellectual property.
- If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed.
- We may be subject to claims that our employees, consultants, or advisors have wrongfully used or disclosed alleged trade secrets of their current or former employers or claims asserting ownership of what we regard as our own intellectual property.
- 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 products and ecDTx.
- Third-party claims of intellectual property infringement, misappropriation, or other violations against us or our collaborators could be expensive and time consuming and may prevent or delay the development and commercialization of our ecDTx.
- We may become involved in lawsuits to protect or enforce our patents and other intellectual property rights, which could be expensive, time-consuming, and unsuccessful.
- If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest, and our business may be adversely affected.
- Intellectual property rights do not necessarily address all potential threats.
- We may not be successful in obtaining or maintaining necessary rights to product components and processes for our development pipeline through acquisitions and in-licenses.
- Risks Related to Ownership of Our Common Stock
- An active, liquid, and orderly market for our common stock may not be sustained, or we may in the future fail to satisfy the continued listing requirements of Nasdaq.
- The trading price of the shares of our common stock could be highly volatile, and purchasers of our common stock could incur substantial losses.
- Our executive officers, directors, and principal stockholders, if they choose to act together, have the ability to significantly influence all matters submitted to stockholders for approval.
- We do not currently intend to pay dividends on our common stock, so any returns on your investment will be limited to the value of our common stock.
- Sales of a substantial number of shares of our common stock by our existing stockholders in the public market could cause our stock price to fall.
- We are an emerging growth company and a smaller reporting company, and the reduced disclosure requirements applicable to emerging growth companies and smaller reporting companies may make our common stock less attractive to investors.
- Provisions in our charter documents and under Delaware law could discourage a takeover that stockholders may consider favorable and may lead to entrenchment of management.
- Our amended and restated certificate of incorporation provides that the Court of Chancery of the State of Delaware is the exclusive forum for substantially all disputes between us and our stockholders and that the federal district courts are the exclusive forum for the resolution of any complaint asserting a cause of action arising under the Securities Act, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.
- General Risk Factors
- We incur significant costs as a result of operating as a public company, and our management is required to devote substantial time to new compliance initiatives.
- We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. We could face criminal liability and other serious consequences for violations, which could harm our business.
Legal proceedings
There currently is no material pending legal proceeding to which we are a party or to which any of our property is subject. From time to time, we may become involved in legal proceedings or subject to claims incident to the ordinary course of business. Regardless of outcome, such proceedings or claims can have an adverse impact on us because of defense and settlement costs, diversion of resources, negative publicity, reputational harm, and other factors and there can be no assurances that favorable outcomes will be obtained.
The opening of Item 3, Legal Proceedings.8
Links
- Websiteboundlessbio.com1
- WikidataQ104481180
- SEC EDGARCIK 1782303
Sources
The numbers on this page point here. Each one links to the record it came from.
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- 10SEC EDGARJami Rubin, Chief financial officer
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- 13SEC EDGARJessica Oien, Officer
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- 16SEC EDGARDavid A. Hinkle, Officer
- 17SEC EDGARJames Christensen, Board member
- 18SEC EDGARJennifer Lew, Board member
- 19SEC EDGARJonathan E. Lim, Board member
- 20SEC EDGARKristina Burow, Board member
- 21SEC EDGARNancy Whiting, Board member
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- 23SEC EDGAREntered a material agreement
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- 25SEC EDGARShareholder vote
- 26SEC EDGARResults of operations
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- 29SEC EDGARResults of operations
- 30SEC EDGARResults of operations
- 31SEC EDGARShareholder vote
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- 33SEC EDGARResults of operations
- 34SEC EDGAREntered a material agreement
- 35NasdaqNasdaq calendar
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