Boundless Bio (BOLD) FY 2025 Conference June 09, 2025 09:20 AM ET Speaker0 Alright. Welcome, everyone. We for for the next session, we have, Zach Hornby from Boundless Bio joining us. Zach, welcome. It's the time for me to host you at at the Goldman Sachs conference. Maybe I'll just turn it to you for opening remarks before we kick it off with questions. Speaker1 Sure. Good morning, Rich, and thank you for hosting. Nice to be here in Miami on a Monday morning. So, yeah, Speaker0 I'm Speaker1 CEO of Boundles ...

SAN DIEGO, June 05, 2025 (GLOBE NEWSWIRE) -- Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company interrogating extrachromosomal DNA (ecDNA) biology to deliver transformative therapies to patients with previously intractable oncogene amplified cancers, today announced that Zachary Hornby, President and Chief Executive Officer, will participate in a fireside chat at the Goldman Sachs 46th Annual Global Healthcare Conference. The fireside chat session is scheduled for Monday, June 9, in Miami, FL, ...

Summary of Boundless Bio (BOLD) Update / Briefing May 27, 2025 Company Overview - **Company**: Boundless Bio (BOLD) - **Focus**: Development of therapies for oncogene amplified cancers, particularly through the study of extrachromosomal DNA (e cDNA) biology [5][6] Key Industry Insights - **Industry Context**: The biotechnology sector is facing challenges in securing funding and establishing differentiation due to a proliferation of competitor compounds [38] - **Market Considerations**: The company is prioritizing first-in-class drugs against innovative biological targets to maintain a competitive edge [38] Core Points and Arguments 1. **Portfolio Prioritization**: Boundless Bio has decided to discontinue all current arms of the BBI-355 clinical trial due to clinical observations and market considerations, shifting focus to a new trial arm evaluating BBI-355 in combination with BBI-825 [3][4] 2. **Workforce Reduction**: The company has streamlined operations, reducing its workforce by approximately 20 positions, representing about one-third of its staff, to extend its cash runway into the first half of 2028 [4][36] 3. **Development Candidates**: BBI-940 has been declared a development candidate for the novel kinesin oral degrader program, with an IND filing expected in the first half of 2026 [4][36] 4. **Clinical Findings**: BBI-355 has shown evidence of anti-tumor activity but has a narrow therapeutic index due to on-target hematologic toxicity, leading to the decision not to advance certain clinical arms [12][14] 5. **Combination Therapy Rationale**: The combination of BBI-355 and BBI-825 is believed to provide synergistic anti-tumor activity while minimizing hematologic toxicity, with plans to initiate clinical development in 2025 [28][29] Additional Important Content - **Scientific Basis**: The company has developed a proprietary SpyGlass platform to identify new targets in e cDNA biology, leading to the discovery of three druggable targets that may be synthetic lethal in oncogene amplified tumors [5][6] - **Clinical Strategy**: The combination of BBI-355 and BBI-825 is expected to leverage the unique mechanisms of both drugs, potentially overcoming the limitations observed when each is used independently [20][28] - **Preclinical Data**: BBI-940 has demonstrated potent anti-tumor activity in preclinical models, with favorable pharmacokinetics and oral bioavailability [33][34] - **Future Outlook**: The company is focused on achieving important clinical readout milestones and believes it is uniquely positioned with proprietary selective inhibitors [39][70] Financial Guidance - **Cash Runway**: The changes in operations and portfolio prioritization are expected to extend the company's cash runway into the first half of 2028, aligning with anticipated clinical readouts [36][37]

Portfolio prioritization focuses on novel-novel combination therapy of BBI-355 and BBI-825 and new development candidate, BBI-940, for novel kinesin program Operating runway extended into the first half of 2028, through expected proof-of-concept clinical readouts for each program Conference call and webcast to be held Tuesday, May 27 at 8:00 am ET SAN DIEGO, May 23, 2025 (GLOBE NEWSWIRE) -- Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company interrogating extrachromosomal DNA (ecDNA) biology to ...

Core Insights - Smirnoff launched its new flavor, Electric Guava, at a vibrant event called Calle Electric in Miami, showcasing a blend of cultural expression and music [1][2] - The event featured a surprise debut of a new track by DJs Coco & Breezy, enhancing the overall experience of the new flavor [2] - Electric Guava is designed for easy sipping, combining guava and ginger flavors, and is priced at $12.99 for a 750 ml bottle [3] Product Details - Electric Guava has a 25% alcohol by volume (ABV) and is available nationwide, with a limited supply encouraging consumers to purchase quickly [3][4] - The classic Spicy Tamarind flavor is also highlighted, priced similarly at $12.99 for a 750 ml bottle but with a higher ABV of 30% [4] - Smirnoff continues to innovate with its product offerings, including ready-to-serve beverages and limited editions that cater to evolving consumer tastes [10] Brand Strategy - The introduction of Electric Guava reflects Smirnoff's commitment to celebrating cultural flavors, particularly those rooted in Hispanic culture [4] - The brand emphasizes diversity and inclusion, aiming to create enjoyable experiences for all consumers aged 21 and above [8] - Smirnoff has a long history of adapting to consumer preferences, having launched various iconic products since its inception in 1864 [7][10]

Core Viewpoint - Boundless Bio, Inc. (BOLD) has received a Zacks Rank 2 (Buy) upgrade, indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Impact - The Zacks rating system is based on changes in earnings estimates, which have a strong correlation with near-term stock price movements [4][6]. - Rising earnings estimates for Boundless Bio suggest an improvement in the company's underlying business, which could lead to higher stock prices as investors respond positively [5][10]. Recent Performance and Projections - Boundless Bio is projected to earn -$3.01 per share for the fiscal year ending December 2025, reflecting a year-over-year change of 21.8% [8]. - Over the past three months, the Zacks Consensus Estimate for Boundless Bio has increased by 10%, indicating a positive revision trend [8]. Zacks Rating System Overview - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with only the top 20% receiving a 'Strong Buy' or 'Buy' rating [9][10]. - The Zacks Rank 2 upgrade places Boundless Bio in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

[PART I. FINANCIAL INFORMATION](index=9&type=section&id=PART%20I.%20FINANCIAL%20INFORMATION) [Financial Statements (Unaudited)](index=9&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents Boundless Bio, Inc.'s unaudited condensed financial statements, including balance sheets, statements of operations, stockholders' equity, and cash flows, for the three months ended March 31, 2025 and 2024, reporting a net loss of **$15,758 thousand** for Q1 2025 [Condensed Balance Sheets](index=9&type=section&id=Condensed%20Balance%20Sheets) Total assets decreased to **$191,242 thousand** as of March 31, 2025, from **$206,409 thousand** at year-end 2024, primarily due to reduced cash and cash equivalents, while total stockholders' equity declined to **$136,592 thousand** Condensed Balance Sheet Highlights (in thousands) | Account | March 31, 2025 (unaudited) | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $15,117 | $26,587 | | Short-term investments | $123,136 | $125,527 | | **Total current assets** | **$140,364** | **$154,390** | | **Total assets** | **$191,242** | **$206,409** | | Total current liabilities | $6,338 | $8,135 | | **Total liabilities** | **$54,650** | **$55,767** | | **Total stockholders' equity** | **$136,592** | **$150,642** | [Condensed Statements of Operations and Comprehensive Loss](index=10&type=section&id=Condensed%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of **$15,758 thousand** for the three months ended March 31, 2025, an increase from **$15,430 thousand** in the prior year, driven by higher general and administrative expenses Condensed Statement of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Research and development | $12,138 | $13,129 | | General and administrative | $5,203 | $3,754 | | **Total operating expenses** | **$17,341** | **$16,883** | | Loss from operations | $(17,341) | $(16,883) | | **Net loss** | **$(15,758)** | **$(15,430)** | | Net loss per share, basic and diluted | $(0.71) | $(12.27) | [Condensed Statements of Cash Flows](index=12&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was **$14,530 thousand** for Q1 2025, a decrease from **$15,776 thousand** in the prior year, with **$3,060 thousand** provided by investing activities and no financing activities Condensed Statement of Cash Flows (in thousands) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(14,530) | $(15,776) | | Net cash provided by investing activities | $3,060 | $18,137 | | Net cash used in financing activities | $0 | $(924) | | **Net (decrease)/increase in cash, cash equivalents, and restricted cash** | **$(11,470)** | **$1,437** | [Notes to Condensed Financial Statements](index=13&type=section&id=Notes%20to%20Condensed%20Financial%20Statements) The notes detail the company's financial statements, including its April 2024 IPO which raised **$87,700 thousand** in net proceeds, and its current cash position of **$138,300 thousand** expected to fund operations for at least twelve months - The company completed its Initial Public Offering (IPO) on April 2, 2024, selling 6,250,000 shares at $16.00 per share, resulting in net proceeds of approximately **$87,700 thousand**[29](index=29&type=chunk) - As of March 31, 2025, the company had **$138,300 thousand** in cash, cash equivalents, and short-term investments, which it believes is sufficient to fund operations for at least the next twelve months[33](index=33&type=chunk) - The company has an accumulated deficit of **$217,200 thousand** as of March 31, 2025, and expects to incur significant losses for the foreseeable future[34](index=34&type=chunk) - In April 2025, the company entered into an Open Market Sale Agreement to sell up to **$14,500 thousand** of its common stock in "at the market" offerings; no shares have been sold under this agreement as of the report date[79](index=79&type=chunk)[80](index=80&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition and operations, highlighting its clinical-stage oncology focus, lead candidate BBI-355 in Phase 1/2 trials, a net loss of **$15,758 thousand** for Q1 2025, and **$138,300 thousand** in cash and investments expected to fund operations into 2027 - The company's lead ecDTx, BBI-355, is in a Phase 1/2 clinical trial (POTENTIATE) for patients with oncogene amplified cancers, with preliminary safety and antitumor activity data expected in **H2 2025**[85](index=85&type=chunk) - The company made a strategic decision in December 2024 to discontinue dose escalation of its BBI-825 STARMAP clinical trial[86](index=86&type=chunk) - The company expects to select a development candidate for its Kinesin program by **mid-2025** and submit an IND in the **first half of 2026**[87](index=87&type=chunk) - As of March 31, 2025, the company had **$138,300 thousand** in cash, cash equivalents, and short-term investments, which is believed to be sufficient to fund operations into **2027**[92](index=92&type=chunk)[118](index=118&type=chunk) R&D Expense Breakdown (in thousands) | Program | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | BBI-355 | $2,954 | $2,231 | | BBI-825 | $1,146 | $2,136 | | Other development programs | $801 | $1,220 | | **Total direct program costs** | **$4,901** | **$5,587** | | Indirect program costs | $7,237 | $7,542 | | **Total R&D expenses** | **$12,138** | **$13,129** | - R&D expenses decreased by **$1,000 thousand** year-over-year, primarily due to reduced spending on the BBI-825 trial and lower outside services costs, partially offset by increased facilities-related expenses from a new headquarters[113](index=113&type=chunk) - G&A expenses increased by **$1,400 thousand** year-over-year, driven by higher facilities costs, stock-based compensation, and costs associated with operating as a public company[114](index=114&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Boundless Bio is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Boundless Bio is not required to provide quantitative and qualitative disclosures about market risk[136](index=136&type=chunk) [Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2025, and as a newly public company, it is not yet required to evaluate internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by this report[137](index=137&type=chunk) - The company is not yet required to have management evaluate the effectiveness of its internal control over financial reporting due to the transition period for newly public companies[138](index=138&type=chunk) [PART II. OTHER INFORMATION](index=40&type=section&id=PART%20II.%20OTHER%20INFORMATION) [Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material pending legal proceedings and is unaware of any contemplated governmental proceedings - There are no material pending legal proceedings to which the company is a party[140](index=140&type=chunk) [Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) No material changes have occurred in the risk factors since the filing of the Annual Report on Form 10-K for the year ended December 31, 2024 - No material changes have occurred in the risk factors since the filing of the Annual Report on Form 10-K for the year ended December 31, 2024[141](index=141&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=40&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities during the period, and there has been no material change in the planned use of IPO proceeds - There were no unregistered sales of equity securities in the quarter[142](index=142&type=chunk) - The planned use of proceeds from the IPO has not materially changed[143](index=143&type=chunk) [Other Information](index=40&type=section&id=Item%205.%20Other%20Information) A Rule 10b5-1 trading plan for former Chief Business Officer Neil Abdollahian was terminated on January 29, 2025, with no sales occurring prior to termination - On January 29, 2025, a Rule 10b5-1 trading plan for former Chief Business Officer Neil Abdollahian was terminated[150](index=150&type=chunk)

Exhibit 99.1 Boundless Bio Reports First Quarter 2025 Financial Results and Business Highlights Initial proof-of-concept data from the ongoing BBI-355 Phase 1/2 POTENTIATE trial in patients with oncogene-amplified cancers anticipated in the second half of 2025 Novel Kinesin program on track for mid-2025 development candidate nomination and IND filing in the first half of 2026 $138 million cash position provides operating runway into 2027 BBI-355, a novel, oral, potent CHK1 inhibitor designed to target repli ...

Initial proof-of-concept data from the ongoing BBI-355 Phase 1/2 POTENTIATE trial in patients with oncogene-amplified cancers anticipated in the second half of 2025 Novel Kinesin program on track for mid-2025 development candidate nomination and IND filing in the first half of 2026 $138 million cash position provides operating runway into 2027 SAN DIEGO, May 09, 2025 (GLOBE NEWSWIRE) -- Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company interrogating extrachromosomal DNA (ecDNA) biology to del ...

[Part I](index=3&type=section&id=PART%20I) [Business](index=5&type=section&id=Item%201.%20Business) Boundless Bio develops ecDNA-targeted oncology therapies, with lead candidate BBI-355 in Phase 1/2 trials, leveraging its Spyglass platform and ECHO diagnostic [Overview](index=7&type=section&id=Item%201.%20Business-Overview) Boundless Bio develops ecDNA-directed oncology therapies, with lead candidate BBI-355 in Phase 1/2 trials and a Kinesin program advancing - The company's mission is to develop transformative therapies for patients with intractable oncogene amplified cancers by interrogating **ecDNA** biology[22](index=22&type=chunk) - Lead candidate **BBI-355**, a **CHK1** inhibitor, is in a **Phase 1/2** trial (**POTENTIATE**) for oncogene amplified cancers, with preliminary data expected in **H2 2025**[24](index=24&type=chunk) - The **Kinesin program** is advancing, with a development candidate nomination expected by **mid-2025** and an **IND** submission planned for **H1 2026**[24](index=24&type=chunk) - The company strategically discontinued the **BBI-825 program** in **December 2024** after assessing preliminary pharmacokinetic data from its **Phase 1/2 STARMAP** trial[25](index=25&type=chunk) - The proprietary **ECHO** diagnostic is being used as a clinical trial assay to detect **ecDNA** and select patients for the **BBI-355 POTENTIATE** trial[26](index=26&type=chunk) [Unmet Need and Role of ecDNA in Cancer](index=13&type=section&id=Item%201.%20Business-Unmet%20Need%20and%20Role%20of%20ecDNA) Oncogene amplification, driven by ecDNA in 14-17% of cancers, leads to poor survival and rapid therapeutic resistance, highlighting a critical unmet need - Patients with oncogene amplified tumors have **significantly worse survival rates** compared to those with mutations or fusions of the same oncogenes[50](index=50&type=chunk)[51](index=51&type=chunk) - Standard targeted therapies, such as **CDK4/6** and **FGFR** inhibitors, have demonstrated **poor overall response rates** in patients with corresponding gene amplifications[57](index=57&type=chunk) - **ecDNA** is a primary driver of oncogenesis, found in **14-17%** of cancer patients, and is associated with **even worse survival outcomes** than other forms of oncogene amplification[69](index=69&type=chunk)[76](index=76&type=chunk)[80](index=80&type=chunk) - **ecDNA** facilitates **rapid therapeutic resistance** by enabling genomic plasticity, such as oncogene switching or amplifying resistance genes like **KRAS G12C**[78](index=78&type=chunk)[83](index=83&type=chunk)[89](index=89&type=chunk) [Our Approach and Spyglass Platform](index=22&type=section&id=Item%201.%20Business-Our%20Approach%20and%20Spyglass%20Platform) Boundless Bio targets ecDNA function using its Spyglass platform, identifying synthetic lethal vulnerabilities in oncogene amplified tumors - The company's strategy is to inhibit cellular machinery essential for **ecDNA** function (e.g., replication, segregation), creating a **synthetic lethal effect** in cancer cells reliant on **ecDNA**[92](index=92&type=chunk)[93](index=93&type=chunk) - The **Spyglass platform** is a proprietary system for identifying and validating **ecDNA**-related drug targets[95](index=95&type=chunk)[97](index=97&type=chunk) - **Spyglass** utilizes a library of **~2,000 cancer models** (**~300 in-house**), specialized analytical tools (including **CRISPR** and imaging), and extensive bioinformatics data to identify vulnerabilities[98](index=98&type=chunk)[102](index=102&type=chunk) - The platform has identified multiple potential targets across the **ecDNA** life cycle, including those involved in segregation, replication, transcription, and repair[105](index=105&type=chunk) [Our Pipeline of ecDNA-Directed Therapeutic Candidates](index=28&type=section&id=Item%201.%20Business-Our%20Pipeline) The pipeline features BBI-355 (CHK1 inhibitor) in Phase 1/2, a Kinesin program, and the ECHO diagnostic for patient selection - The pipeline includes **BBI-355** (**CHK1** inhibitor), a **Kinesin program**, and **BBI-098** (**CNS**-penetrant **CHK1** inhibitor), all discovered internally via the **Spyglass platform**[110](index=110&type=chunk)[112](index=112&type=chunk)[116](index=116&type=chunk) - **BBI-355** is an oral, selective **CHK1** inhibitor designed to exploit elevated replication stress in **ecDNA**-enabled cancer cells. Preliminary clinical data from the **POTENTIATE** trial is expected in **H2 2025**[113](index=113&type=chunk)[127](index=127&type=chunk) - Preliminary **Phase 1** data for **BBI-355** showed **good oral bioavailability**, **target engagement** (**pCHK1** reduction), and **stable disease in 5 of 18** evaluable subjects, with one patient showing **~20% tumor regression**[160](index=160&type=chunk)[163](index=163&type=chunk)[166](index=166&type=chunk) - The **Kinesin program** targets a novel kinesin essential for **ecDNA** segregation. The company has developed oral nanomolar degraders and expects to nominate a development candidate by **mid-2025** and submit an **IND** in **H1 2026**[183](index=183&type=chunk) - **BBI-098** is a second, **CNS**-penetrant **CHK1** inhibitor nominated as a development candidate, potentially for **CNS** indications like **glioblastoma**[176](index=176&type=chunk) [Competition](index=52&type=section&id=Item%201.%20Business-Competition) The company faces competition from major biopharma and biotech firms, including clinical-stage CHK1 inhibitors and other ecDNA researchers - The company faces broad competition from entities developing precision oncology therapies and treatments based on synthetic lethality[188](index=188&type=chunk) - Direct competitors for the **BBI-355 CHK1** inhibitor program include **Acrivon Therapeutics**, **Esperas Pharma**, **Sumitomo Pharma**, and **PharmaEngine**, all of whom have **CHK1** inhibitors in clinical development[190](index=190&type=chunk) - While **Boundless Bio** is a leader in **ecDNA**-directed therapeutics, it notes **Econic Biosciences** as another early-stage company focused on **ecDNA** research[191](index=191&type=chunk) [Intellectual Property](index=54&type=section&id=Item%201.%20Business-Intellectual%20Property) The IP portfolio includes 25 patent families covering CHK1 inhibitors and the ECHO diagnostic, with expirations between 2041-2045 - As of **March 27, 2025**, the company's **IP** portfolio includes **25 solely owned patent families**, with **4 issued U.S. patents** and **14 pending U.S. non-provisional applications**[194](index=194&type=chunk) - The **CHK1 program** (**BBI-355**, **BBI-098**) is protected by **10 patent families**, with expected patent expirations in **2041-2045**[197](index=197&type=chunk) - The precision medicine program, including the **ECHO diagnostic**, is covered by patent families with expected expirations in **2041-2044**[198](index=198&type=chunk) - The company also protects its technology through trade secrets and has **registered trademarks** for "**Boundless Bio**" and "**ECHO**" in the **U.S.** and other jurisdictions[203](index=203&type=chunk)[204](index=204&type=chunk) [Manufacturing, Commercialization, and Regulation](index=56&type=section&id=Item%201.%20Business-Manufacturing,%20Commercialization,%20and%20Regulation) The company outsources manufacturing, plans internal commercialization, and navigates extensive FDA regulations for therapeutics and companion diagnostics - The company does not own or operate manufacturing facilities and relies entirely on **third-party contract manufacturers** for its **ecDTx** supply[205](index=205&type=chunk) - **Boundless Bio** plans to build its **own sales and marketing infrastructure** to commercialize approved products in the **U.S.** and other key markets[207](index=207&type=chunk) - The company's operations are subject to extensive regulation by the **FDA**, including requirements for preclinical studies (**GLP**), clinical trials (**IND**, **GCP**), and manufacturing (**cGMP**) before an **NDA** can be submitted for approval[208](index=208&type=chunk)[211](index=211&type=chunk) - The company may pursue expedited **FDA** programs like **Fast Track**, **Breakthrough Therapy**, or **Accelerated Approval** to speed up development and review[227](index=227&type=chunk)[228](index=228&type=chunk)[230](index=230&type=chunk) - Development of a companion diagnostic, like **ECHO**, is also regulated by the **FDA** as a medical device, likely requiring a **Premarket Approval (PMA)** to be approved contemporaneously with the therapeutic product[240](index=240&type=chunk)[241](index=241&type=chunk) [Human Capital and Corporate Information](index=72&type=section&id=Item%201.%20Business-Human%20Capital%20and%20Corporate%20Information) As of March 21, 2025, Boundless Bio had 64 employees, with 47 in R&D, and was founded in 2018 as Pretzel Therapeutics - As of **March 21, 2025**, the company had **64 full-time employees**, with **47 dedicated to R&D**[262](index=262&type=chunk) - The company was founded on **April 10, 2018**, as **Pretzel Therapeutics, Inc.** and changed its name to **Boundless Bio, Inc.** on **July 8, 2019**[265](index=265&type=chunk) [Risk Factors](index=74&type=section&id=Item%201A.%20Risk%20Factors) The company faces significant financial losses, unproven novel science, clinical trial uncertainties, reliance on third parties, and intense competition - **Financial Risks:** The company has a history of significant losses (**$65.4M** in **2024**) and expects them to continue. It will require **substantial additional capital** to fund operations, and failure to secure it could force delays or termination of programs[273](index=273&type=chunk)[275](index=275&type=chunk) - **Development & Regulatory Risks:** The company's **ecDNA**-targeting approach is **novel and unproven**. Clinical trials are long and expensive with uncertain outcomes. The lead candidate, **BBI-355**, could fail, and development of a necessary companion diagnostic (**ECHO**) faces its own regulatory and technical hurdles[287](index=287&type=chunk)[292](index=292&type=chunk)[316](index=316&type=chunk) - **Reliance on Third Parties:** **Boundless Bio** depends on **third parties** for manufacturing its **ecDTx** and conducting clinical trials. Poor performance by these partners could significantly delay development and commercialization[344](index=344&type=chunk)[347](index=347&type=chunk) - **Commercialization Risks:** The company faces **significant competition** from well-funded pharmaceutical companies. Success depends on **market acceptance**, securing **adequate reimbursement** from payors, and building a commercial organization, none of which is guaranteed[363](index=363&type=chunk)[368](index=368&type=chunk)[375](index=375&type=chunk) - **Intellectual Property Risks:** The ability to **obtain, maintain, and enforce patents** is critical and uncertain. Patents may be challenged, invalidated, or circumvented by competitors[432](index=432&type=chunk) [Unresolved Staff Comments](index=158&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) The company reports no unresolved staff comments from the SEC - **None**[520](index=520&type=chunk) [Cybersecurity](index=158&type=section&id=Item%201C.%20Cybersecurity) The company's cybersecurity program, guided by NIST, is overseen by the Audit Committee, with no material risks identified to date - The company's cybersecurity risk management program is based on the **NIST Cybersecurity Framework** principles (**Identify**, **Protect**, **Detect**, **Respond**, **Recover**)[521](index=521&type=chunk) - Oversight is provided by the **Audit Committee of the Board of Directors**, which receives periodic reports from management[524](index=524&type=chunk) - As of the filing date, **no known cybersecurity threats or incidents** have had a **material impact** on the company[523](index=523&type=chunk) [Properties](index=159&type=section&id=Item%202.%20Properties) The company leases 80,168 square feet of headquarters space in San Diego, California, under a lease expiring in October 2034 - The company leases approximately **80,168 square feet** of laboratory and office space in **San Diego, California**[527](index=527&type=chunk) - The current lease expires in **October 2034**[527](index=527&type=chunk) [Legal Proceedings](index=159&type=section&id=Item%203.%20Legal%20Proceedings) There are no material pending legal proceedings involving the company or its property - There is **no material pending legal proceeding** to which the company is a party[528](index=528&type=chunk) [Mine Safety Disclosures](index=159&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - **Not applicable**[529](index=529&type=chunk) [Part II](index=160&type=section&id=PART%20II) [Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer Purchases of Equity Securities](index=160&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity,%20Related%20Stockholder%20Matters,%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Common stock began trading on Nasdaq in March 2024; the company has never paid dividends and reallocated IPO proceeds to advance its pipeline - Common stock began trading on **Nasdaq** under the symbol "**BOLD**" on **March 28, 2024**[532](index=532&type=chunk) - The company has **never paid dividends** and does not intend to in the foreseeable future[534](index=534&type=chunk) - The **IPO** on **April 2, 2024**, generated net proceeds of approximately **$87.7 million**[538](index=538&type=chunk) - Use of **IPO** proceeds has been updated: funds from the discontinued **BBI-825 program** will be reallocated to advance **BBI-355**, the **Kinesin program**, and for general corporate purposes[539](index=539&type=chunk)[540](index=540&type=chunk) [Reserved](index=162&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=163&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) The company reported a $65.4 million net loss in 2024, with $152.1 million cash expected to fund operations into 2027, requiring future capital [Results of Operations](index=169&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations-Results%20of%20Operations) Net loss increased to $65.4 million in 2024 due to higher R&D and G&A expenses, partially offset by increased interest income Results of Operations (in thousands) | | Year Ended December 31, | | Change | | :--- | :--- | :--- | :--- | | | **2024** | **2023** | **Amount** | | **Research and development** | $55,267 | $42,637 | $12,630 | | **General and administrative** | $18,000 | $12,159 | $5,841 | | **Total operating expenses** | $73,267 | $54,796 | $18,471 | | **Loss from operations** | ($73,267) | ($54,796) | ($18,471) | | **Total other income, net** | $7,904 | $5,362 | $2,542 | | **Net loss** | **($65,363)** | **($49,434)** | **($15,929)** | - **R&D** expenses increased by **$12.6 million**, primarily due to a **$9.2 million** rise in direct program costs for the **BBI-355** and **BBI-825** clinical trials, alongside higher personnel and stock compensation costs[571](index=571&type=chunk) - **G&A** expenses increased by **$5.8 million**, driven by a **$2.6 million** increase in stock-based compensation, a **$1.2 million** rise in personnel costs, and a **$0.8 million** increase in costs related to operating as a public company[572](index=572&type=chunk)[573](index=573&type=chunk) [Liquidity and Capital Resources](index=171&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations-Liquidity%20and%20Capital%20Resources) As of December 31, 2024, the company had $152.1 million in cash, expected to fund operations into 2027, but requires substantial future funding - As of **December 31, 2024**, the company held **$152.1 million** in cash, cash equivalents, and short-term investments[576](index=576&type=chunk) - Current cash position is expected to fund operations into **2027**[576](index=576&type=chunk) Cash Flow Summary (in thousands) | | Year Ended December 31, | Change | | :--- | :--- | :--- | :--- | | | **2024** | **2023** | **Amount** | | **Net cash used in operating activities** | ($60,841) | ($46,855) | ($13,986) | | **Net cash used in investing activities** | ($26,101) | ($38,260) | $12,159 | | **Net cash provided by financing activities** | $89,823 | $97,897 | ($8,074) | - The company has future aggregate operating lease commitments of **$72.5 million**, expiring in **October 2034**[586](index=586&type=chunk) [Critical Accounting Policies and Estimates](index=174&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations-Critical%20Accounting%20Policies) Critical accounting policies include estimating accrued R&D expenses and valuing stock-based compensation, both requiring significant judgment - **Accrued R&D Expenses:** The company is required to estimate expenses for services performed by **third-party vendors** (e.g., **CROs**) before invoices are received. This involves estimating the level of service completed based on contracts and communication with personnel[591](index=591&type=chunk)[592](index=592&type=chunk) - **Stock-Based Compensation:** The company uses the **Black-Scholes model** to determine the fair value of equity awards. This requires subjective assumptions for expected term, volatility, and risk-free rate. Prior to the **IPO**, determining the fair value of the company's common stock was also a critical estimate[595](index=595&type=chunk)[596](index=596&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=178&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company faces minimal interest rate or foreign currency risk due to short-term investments and limited international contracts - Interest rate risk on the company's cash and short-term investments is **not considered significant** due to the short-term nature of the portfolio[603](index=603&type=chunk) - Foreign currency exchange risk from contracts with overseas vendors is considered **negligible**, and the company does not engage in hedging[604](index=604&type=chunk) - Inflation is **not believed to have had a material effect** on the company's results of operations[606](index=606&type=chunk) [Financial Statements and Supplementary Data](index=178&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data) Financial statements and the independent auditor's report are included starting on page F-1 of the Form 10-K - The company's financial statements and the auditor's report are located at the end of the report, beginning on page **F-1**[607](index=607&type=chunk) [Changes in and Disagreements with Accountants on Accounting and Financial Disclosure](index=178&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20with%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - **None**[608](index=608&type=chunk) [Controls and Procedures](index=179&type=section&id=Item%209A.%20Controls%20and%20Procedures) Disclosure controls were effective as of December 31, 2024, with no material changes to internal controls during the quarter - Management concluded that disclosure controls and procedures were **effective** as of **December 31, 2024**[610](index=610&type=chunk) - A management report on internal control over financial reporting is not included due to the transition period for newly public companies[611](index=611&type=chunk) - **No material changes** were made to internal control over financial reporting during the quarter ended **December 31, 2024**[612](index=612&type=chunk) [Other Information](index=179&type=section&id=Item%209B.%20Other%20Information) SVP of Finance adopted a 10b5-1 plan, while the former CFO terminated her plan in Q4 2024 - On **December 27, 2024**, **David Hinkle** (**SVP**, Finance) adopted a **Rule 10b5-1 trading plan** covering **12,000 shares**, expiring **December 31, 2025**[614](index=614&type=chunk) - On **October 18, 2024**, **former CFO Jami Rubin** terminated her trading plan following her departure from the company[614](index=614&type=chunk)[617](index=617&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=181&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections) This item is not applicable - **None**[615](index=615&type=chunk) [Part III](index=182&type=section&id=PART%20III) [Directors, Executive Officers, and Corporate Governance](index=182&type=section&id=Item%2010.%20Directors,%20Executive%20Officers,%20and%20Corporate%20Governance) Information on directors, executive officers, and corporate governance is incorporated by reference from the 2025 proxy statement - Information is **incorporated by reference** from the definitive proxy statement for the **2025 Annual Meeting of Stockholders**[619](index=619&type=chunk) [Executive Compensation](index=182&type=section&id=Item%2011.%20Executive%20Compensation) Executive compensation information is incorporated by reference from the 2025 proxy statement - Information is **incorporated by reference** from the definitive proxy statement for the **2025 Annual Meeting of Stockholders**[620](index=620&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=182&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters) Security ownership and equity compensation plan details are incorporated by reference from the 2025 proxy statement - Information is **incorporated by reference** from the definitive proxy statement for the **2025 Annual Meeting of Stockholders**[621](index=621&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=182&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions,%20and%20Director%20Independence) Related person transactions and director independence information is incorporated by reference from the 2025 proxy statement - Information is **incorporated by reference** from the definitive proxy statement for the **2025 Annual Meeting of Stockholders**[622](index=622&type=chunk) [Principal Accountant Fees and Services](index=182&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services) Principal accountant fees and services information is incorporated by reference from the 2025 proxy statement; KPMG LLP is the auditor - Information is **incorporated by reference** from the definitive proxy statement for the **2025 Annual Meeting of Stockholders**[623](index=623&type=chunk) - The company's independent public accounting firm is **KPMG LLP**[623](index=623&type=chunk) [Part IV](index=183&type=section&id=PART%20IV) [Exhibits and Financial Statement Schedules](index=183&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules) This section provides an index of all exhibits filed with or incorporated by reference into the Form 10-K - This section contains the **Exhibit Index**, listing all documents filed as part of the report[626](index=626&type=chunk)[627](index=627&type=chunk) [Form 10-K Summary](index=185&type=section&id=Item%2016.%20Form%2010-K%20Summary) The company indicates that no Form 10-K summary is provided - **None**[631](index=631&type=chunk) [Financial Statements](index=188&type=section&id=Financial%20Statements) [Report of Independent Registered Public Accounting Firm](index=189&type=section&id=Report%20of%20Independent%20Registered%20Public%20Accounting%20Firm) KPMG LLP issued an unqualified opinion on the 2024 and 2023 financial statements, without an opinion on internal controls - **KPMG LLP** provided an **unqualified audit opinion** on the financial statements for the years ended **December 31, 2024 and 2023**[644](index=644&type=chunk) - The audit was conducted in accordance with **PCAOB standards**. An audit of internal control over financial reporting was **not performed as it was not required**[646](index=646&type=chunk) [Financial Statements Data](index=190&type=section&id=Financial%20Statements-Data) Financial statements show a $65.4 million net loss in 2024, increased assets from IPO proceeds, and a shift to positive equity Balance Sheet Data (in thousands) | | Dec 31, 2024 | Dec 31, 2023 | | :--- | :--- | :--- | | **Total Assets** | $206,409 | $129,894 | | Cash, cash equivalents, & short-term investments | $152,114 | $120,752 | | **Total Liabilities** | $55,767 | $9,359 | | **Total stockholders' equity / (deficit)** | $150,642 | ($127,082) | Statement of Operations Data (in thousands) | | Year Ended Dec 31, 2024 | Year Ended Dec 31, 2023 | | :--- | :--- | :--- | | Research and development | $55,267 | $42,637 | | General and administrative | $18,000 | $12,159 | | **Loss from operations** | **($73,267)** | **($54,796)** | | **Net loss** | **($65,363)** | **($49,434)** | | **Net loss per share** | **($3.85)** | **($40.65)** | [Notes to Financial Statements](index=194&type=section&id=Notes%20to%20Financial%20Statements) Notes detail the April 2024 IPO, a March 2024 reverse stock split, lease commitments, stock-based compensation, and NOL carryforwards - The company completed its **IPO** on **April 2, 2024**, raising net proceeds of approximately **$87.7 million**. All **convertible preferred stock** was converted to **common stock**[662](index=662&type=chunk) - A **1-for-19.5 reverse stock split** was effected on **March 19, 2024**, and all share data has been retroactively adjusted[664](index=664&type=chunk) - The company entered into a new **120-month lease** (the **2024 Lease**) for its headquarters, which commenced in **November 2024** and has total minimum lease payments of **$72.5 million**[728](index=728&type=chunk)[729](index=729&type=chunk) - In **August 2024**, the company repriced outstanding stock options, reducing the exercise price to **$3.56 per share**, resulting in **$857,000** of incremental stock-based compensation expense to be recognized over time[742](index=742&type=chunk)[745](index=745&type=chunk) - As of **Dec 31, 2024**, the company had federal **NOL** carryforwards of **$91.9 million** and state **NOLs** of **$183.3 million**, but a **full valuation allowance** is recorded against these deferred tax assets[759](index=759&type=chunk)