[Business and Operational Highlights](index=1&type=section&id=Business%20and%20Operational%20Highlights) Boundless Bio anticipates BBI-355 proof-of-concept data in H2 2025 and a Kinesin program IND filing in H1 2026 - Initial proof-of-concept data from the BBI-355 Phase 1/2 POTENTIATE trial in patients with oncogene-amplified cancers is anticipated in the **second half of 2025**[1](index=1&type=chunk)[2](index=2&type=chunk) - The novel Kinesin program is on track to nominate a development candidate by **mid-2025**, with an Investigational New Drug (IND) submission planned for the **first half of 2026**[1](index=1&type=chunk)[3](index=3&type=chunk) - Preclinical data for BBI-825, presented at the AACR Annual Meeting, suggested potential to delay or prevent acquired resistance in colorectal cancer models when combined with RAS targeting inhibitors[4](index=4&type=chunk) [First Quarter 2025 Financial Results](index=2&type=section&id=First%20Quarter%202025%20Financial%20Results) Boundless Bio reported a Q1 2025 net loss of **$15.8 million**, with **$138.3 million** cash supporting operations into 2027 - The company maintains a strong cash position with **$138.3 million** in cash, cash equivalents, and short-term investments as of March 31, 2025, providing an operating runway into **2027**[1](index=1&type=chunk)[8](index=8&type=chunk) Q1 2025 Financial Highlights (vs. Q1 2024) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | R&D Expenses | $12.1 million | $13.1 million | | G&A Expenses | $5.2 million | $3.8 million | | Net Loss | $15.8 million | $15.4 million | [Consolidated Financial Statements](index=4&type=section&id=Consolidated%20Financial%20Statements) Q1 2025 statements detail **$17.3 million** in operating expenses, a **$15.8 million** net loss, and **$191.2 million** in total assets Statement of Operations (Three Months Ended March 31, in thousands) | Line Item | 2025 (in thousands) | 2024 (in thousands) | | :--- | :--- | :--- | | 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) | | Interest income | $1,585 | $1,421 | | **Net loss** | **$(15,758)** | **$(15,430)** | | Net loss per share | $(0.71) | $(12.27) | Balance Sheet Data (in thousands) | Line Item | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :--- | :--- | :--- | | Cash, cash equivalents, and short-term investments | $138,253 | $152,114 | | Total assets | $191,242 | $206,409 | | Total liabilities | $54,650 | $55,767 | | Total stockholders' equity | $136,592 | $150,642 | [Company Overview and Forward-Looking Statements](index=2&type=section&id=Company%20Overview%20and%20Forward-Looking%20Statements) Boundless Bio, an oncology company targeting ecDNA in amplified tumors, notes forward-looking statements are subject to inherent drug development risks - The company's research focuses on extrachromosomal DNA (ecDNA), a root cause of oncogene amplification observed in **14% to 17%** of cancer patients[6](index=6&type=chunk) - The company's lead ecDNA-directed therapeutic candidate (ecDTx) is **BBI-355**, an oral inhibitor of checkpoint kinase 1 (**CHK1**)[6](index=6&type=chunk) - Forward-looking statements are subject to risks including the unproven nature of the company's novel approach, potential clinical trial delays, and regulatory uncertainties[7](index=7&type=chunk)[9](index=9&type=chunk)

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)

Financial Performance - Boundless Bio reported a cash position of $152.1 million as of December 31, 2024, an increase from $120.8 million in 2023[9] - The net loss for Q4 2024 was $16.4 million, compared to a net loss of $12.1 million in Q4 2023, and the full year net loss for 2024 totaled $65.4 million, up from $49.4 million in 2023[9] - The total operating expenses for the full year 2024 were $73.3 million, compared to $54.8 million in 2023[13] Research and Development - Research and Development (R&D) expenses for Q4 2024 were $13.3 million, up from $10.4 million in Q4 2023, and total R&D expenses for the full year 2024 were $55.3 million compared to $42.6 million in 2023[9] - Boundless Bio is advancing the BBI-355 Phase 1/2 POTENTIATE trial, with preliminary proof-of-concept data expected in the second half of 2025[1][2] - The company expects to report preliminary clinical proof-of-concept safety and antitumor activity data for BBI-355 in the second half of 2025[3] - Boundless Bio's ecDNA-directed therapeutic candidate, BBI-355, is being evaluated in a clinical trial targeting oncogene amplified cancers, which affect 14 to 17% of cancer patients[6] General and Administrative Expenses - General and Administrative (G&A) expenses for Q4 2024 were $5.0 million, compared to $3.4 million in Q4 2023, with total G&A expenses for the full year 2024 at $18.0 million versus $12.2 million in 2023[9] Leadership Changes - Boundless Bio appointed Robert Doebele, M.D., Ph.D., as Chief Medical Officer in February 2025, enhancing its leadership in oncology[4] Future Development Plans - The company is on track to nominate a development candidate for its novel Kinesin program by mid-2025, with an IND submission anticipated in the first half of 2026[1][2]

Core Insights - Boundless Bio is advancing its clinical-stage oncology programs, particularly BBI-355, an oral CHK1 inhibitor, with preliminary proof-of-concept data expected in the second half of 2025 [1][2][6] - The company is also progressing a novel Kinesin program aimed at targeting ecDNA segregation, with a development candidate nomination anticipated by mid-2025 and an IND submission planned for the first half of 2026 [1][4][6] Research and Development Highlights - BBI-355 is designed to address replication stress in oncogene-amplified cancers and is currently in a Phase 1/2 POTENTIATE trial [3][6] - The Kinesin program is in preclinical development, focusing on a previously undrugged kinesin essential for ecDNA segregation during cell division [6] Financial Performance - As of December 31, 2024, Boundless Bio reported a cash position of $152.1 million, which is expected to support operations into 2027 [1][7] - Research and Development (R&D) expenses for Q4 2024 were $13.3 million, and for the full year, they totaled $55.3 million, compared to $10.4 million and $42.6 million for the same periods in 2023 [7][8] - General and Administrative (G&A) expenses for Q4 2024 were $5.0 million, with a total of $18.0 million for the full year, up from $3.4 million and $12.2 million in 2023 [7] Corporate Developments - In February 2025, Boundless Bio appointed Robert Doebele, M.D., Ph.D., as Chief Medical Officer, who has extensive experience in oncology program development [4]

Company Overview - Boundless Bio is a clinical-stage oncology company focused on developing therapies for patients with oncogene amplified cancers by targeting extrachromosomal DNA (ecDNA), which is implicated in 14 to 17% of cancer cases [3]. - The company is developing its first ecDNA-directed therapeutic candidate, BBI-355, an oral inhibitor of checkpoint kinase 1 (CHK1), currently in a Phase 1/2 clinical trial [3]. - Boundless Bio utilizes its Spyglass platform for additional programs that are in preclinical development and discovery [3]. Upcoming Events - Zachary Hornby, President and CEO of Boundless Bio, will participate in a fireside chat at Leerink's Global Healthcare Conference on March 12, 2025, at 11:20 a.m. ET in Miami, FL [2]. - A live and archived webcast of the session will be available on Boundless Bio's website under the "Events & Presentations" section [2].

Core Insights - Boundless Bio has appointed Dr. Robert Doebele as Chief Medical Officer, bringing over 15 years of oncology drug development experience to the company [1][2][3] Company Overview - Boundless Bio is a clinical-stage oncology company focused on developing therapies targeting extrachromosomal DNA (ecDNA) to address oncogene amplified cancers, which affect over 14% of cancer patients [4] - The company is advancing its lead candidate, BBI-355, an oral inhibitor of checkpoint kinase 1 (CHK1), currently in a Phase 1/2 clinical trial [4] Leadership and Experience - Dr. Doebele co-founded Rain Oncology, where he directed the development of therapies targeting oncogenic drivers and led clinical development plans for several innovative drugs [2] - He has a notable background in precision oncology, having contributed to the approval of Vitrakvi® and Rozlytrek® through his research on NTRK gene fusions [2] Strategic Focus - The company aims to deliver novel treatment options for patients with oncogene amplified cancers, addressing a significant unmet medical need in the oncology space [3][4]

Market Overview - Wall Street experienced volatility at the start of 2025, following a significant sell-off in late 2024, with the Russell 2000 Index dropping 8.4% in December, its worst month since September 2022, but rebounding 0.4% in the first week of 2025 [1] - The "January Effect" is anticipated to drive smoother trading, characterized by a seasonal increase in stock prices during January [1][3] Investment Opportunities - Small-cap stocks that have declined in double digits or high single digits over the past month, with a Zacks Rank of 1 (Strong Buy) or 2 (Buy) and a Momentum Score of B or higher, are considered solid investment choices [2] - Notable stocks include: - Boundless Bio Inc. (BOLD): Market cap of $58.4 million, down 15.5% in a month, Zacks Rank 2, Momentum Score A [8] - HomeStreet Inc. (HMST): Market cap of $191 million, down 12% in a month, Zacks Rank 2, Momentum Score A [9] - Synchronoss Technologies (SNCR): Market cap of $96.5 million, down 11% in a month, Zacks Rank 2, Momentum Score A, with an estimated earnings growth rate of 99.3% [10] - Pitney Bowes (PBI): Market cap of $1.3 billion, down 8.4% in a month, Zacks Rank 1, Momentum Score A, with an estimated earnings growth rate of 184.2% [11] - USANA Health Sciences Inc. (USNA): Market cap of $673.2 million, down 8.3% in a month, Zacks Rank 1, Momentum Score A, with an estimated growth of 26.1% [12] Economic Context - The economy is reported to be on solid footing, with household net worth at an all-time high and a healthy labor market, indicating a strong economic outlook [5] - Small-cap companies, being more domestically focused, are expected to outperform as the economy improves, supported by President-elect Trump's policies aimed at deregulation and lower corporate tax rates [5][6] - Reduced regulations are anticipated to lower operational costs for small-cap businesses, enhancing profitability [6] - The Federal Reserve's interest rate cuts, totaling 100 basis points since September, are expected to reduce borrowing costs for small businesses, facilitating expansion and profitability [7]

Core Concept - The "Classic or Nothing" campaign by Tanqueray celebrates its legacy and promotes a return to timeless classics, emphasizing quality over trends [1][3]. Group 1: Campaign Overview - The campaign introduces a vibrant look while maintaining the brand's heritage, featuring striking visuals and a refreshed color palette [2]. - It aims to connect with both existing gin lovers and new cocktail enthusiasts through various marketing activations, including digital media and engaging events [2]. Group 2: Experiential Marketing - The campaign launched with the "Classic or Nothing Diner" at the Austin Food & Wine Festival, merging the classic American diner experience with Tanqueray cocktails [3]. - A subsequent event at MetLife Stadium featured a unique pairing of Tanqueray cocktails with a twist on classic dishes, enhancing guest engagement [4]. Group 3: Brand Heritage - Tanqueray has a rich history of over 180 years, founded by Charles Tanqueray in 1830, and is known for its commitment to quality and innovation [7][8]. - The brand has received numerous awards, including being named 'Bartenders' Choice' in the Drinks International Brand Report 2023, highlighting its esteemed position in the industry [8].

Core Insights - Boundless Bio has decided not to advance BBI-825 into the Part 2 portion of the STARMAP clinical trial due to preliminary pharmacokinetic data and increasing development costs in the competitive landscape of BRAF and KRAS-mutated cancer treatment [2][5][6] - The company is focusing resources on BBI-355, which is on track for initial clinical proof-of-concept data in the second half of 2025, and a third ecDTx program, with a development candidate nomination expected by mid-2025 [3][5][6] - Leadership changes include the departure of Klaus Wagner, M.D., Ph.D., and Neil Abdollahian, with James L. Freddo, M.D., stepping in as Interim Chief Medical Officer [4][6] Pipeline Updates - BBI-355 is currently in a Phase 1/2 POTENTIATE clinical trial, targeting oncogene-amplified solid tumors, with preliminary clinical data expected in the second half of 2025 [3][5] - The decision not to advance BBI-825 was based on a lack of dose-proportional exposure observed in the trial and the complexities of the treatment landscape [3][5] - The third ecDTx program is progressing, targeting a kinesin essential for ecDNA segregation, with an IND application expected in the first half of 2026 [3][5] Leadership Transitions - Klaus Wagner, M.D., Ph.D., Chief Medical Officer, and Neil Abdollahian, Chief Business Officer, will leave the company, with James L. Freddo, M.D., taking over as Interim CMO [4][6] - Dr. Freddo has extensive experience in clinical leadership within biopharmaceutical companies [4]