SAN DIEGO, Feb. 05, 2026 (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 Guggenheim Emerging Outlook: Biotech Summit 2026. The fireside chat session is scheduled for Thursday, February 12, in New York, ...

Core Insights - The U.S. FDA has accepted Boundless Bio's Investigational New Drug (IND) application for BBI-940, a novel Kinesin oral degrader program, enabling the initiation of a first-in-human clinical trial for metastatic breast cancer in the first half of 2026 [1][2][3] - The company has decided to discontinue the POTENTIATE trial for BBI-355 and BBI-825, focusing resources on programs with the highest potential for clinical impact [4] - The revised operating plan extends the company's operational runway into the second half of 2028, aligning with the anticipated initial clinical proof-of-concept readout for BBI-940 [5] Company Overview - Boundless Bio is a clinical-stage oncology company focused on developing therapies targeting extrachromosomal DNA (ecDNA), which is linked to oncogene amplification in 14% to 17% of cancer patients [6] - The company is developing BBI-940 as a potentially first-in-class orally bioavailable Kinesin degrader aimed at treating oncogene amplified tumors [6] Clinical Development - BBI-940 has shown potent anti-tumor activity in various cancer cell lines and mouse xenograft models, indicating its potential effectiveness as a treatment [2] - The KOMODO-1 trial will be the first clinical trial for BBI-940, expected to provide initial proof-of-concept data within the company's cash runway timeline [2][3]

Core Insights - The company bubba, part of Newell Brands, is launching a new brand identity and a next-generation lineup of reusable water bottles that emphasize personal expression and style [1][2][3] Brand Evolution - The refreshed brand identity features a modern logo, vibrant color system, and keg-inspired design, reflecting individuality and confidence [3] - The new collection aims to transform hydration into a fashion statement, appealing to younger audiences with bold and expressive designs [4] Product Features - The new bubba collection includes high-performance, leakproof, insulated water bottles designed for active lifestyles, suitable for workouts, travel, and events [4] - Initial products include the bubba 24oz Dual Sip Lid Water Bottle and the bubba 52oz Keg Multi-Function Water Bottle, available in trendy colorways like Fresh Kicks, Moodbooster, and Daydreamin [5] Company Background - Founded in 1997, bubba is recognized for its innovative, durable, and easy-to-clean beverageware, now under Newell Brands' Outdoor and Recreation Business Unit [7] - Newell Brands is a leading global consumer goods company with a diverse portfolio of well-known brands, focusing on enhancing everyday consumer experiences [8]

Core Viewpoint - 21shares has launched the 21shares Bitcoin Gold ETP (BOLD) on the London Stock Exchange, providing a new investment product that combines Bitcoin and gold to offer diversification and inflation protection for retail investors in the UK [2][4]. Group 1: Product Overview - BOLD is the fifth cryptocurrency product from 21shares approved for UK retail investors, following Bitcoin and Ethereum offerings [2]. - The ETP is developed in partnership with ByteTree Asset Management and aims to blend gold and Bitcoin, adjusting allocations based on their historical volatility to maintain a balanced risk profile [3][5]. - BOLD is 100% physically backed by the underlying assets, which are stored in cold storage by an institutional-grade custodian, enhancing security for investors [6]. Group 2: Investment Strategy - The product rebalances monthly to maintain an optimal balance between Bitcoin and gold, aiming for approximately equal risk contribution from both assets [5]. - BOLD has a 3-year Sharpe ratio of 1.79 and an Assets Under Management (AUM) of $40.1 million as of January 12, 2026, indicating a strong performance relative to its risk [5]. Group 3: Market Position and Commentary - Russell Barlow, CEO of 21shares, emphasizes that BOLD offers a hedge against inflation while providing exposure to Bitcoin's growth potential and the stability of gold [7]. - Charles Morris, Founder and CIO of ByteTree Asset Management, notes that Bitcoin and gold are increasingly seen as complementary assets in an inflationary environment, and BOLD provides a transparent solution for diversified exposure [7].

Summary of Boundless Bio FY Conference Call Company Overview - **Company**: Boundless Bio (NasdaqGS:BOLD) - **Industry**: Precision Oncology - **Location**: San Diego - **Established**: Approximately six years ago - **Focus**: Addressing unmet needs in oncology, specifically for patients with oncogene amplification-driven tumors, which represent about 25% of all cancer patients [4][10] Core Scientific Insights - **Extrachromosomal DNA (ecDNA)**: A key area of focus for Boundless Bio, identified as a root cause of oncogene amplifications. This DNA is distinct from chromosomal DNA and is not found in healthy tissues [4][8] - **Oncogene Amplifications**: Represent about 25% of cancers, with ecDNA present in approximately 15% of all cancers, particularly in aggressive tumor types like glioblastoma and metastatic ovarian cancer [10][11] - **Current Treatment Landscape**: There is a lack of approved targeted therapies for oncogene amplifications, with the exception of HER2 in breast cancer. Current treatments often default to chemotherapy, which is not specific to the underlying biology [13] Clinical Development and Pipeline - **Current Programs**: - **BBI-355**: In clinical trials, showing activity but facing challenges with toxicity [16][17] - **BBI-825**: Another program in the clinic with ongoing evaluations [16] - **BBI-940**: A new program targeting a novel kinesin, expected to enter first-in-human studies in the first half of 2026 [22][34] Spyglass Platform - **Function**: A proprietary discovery platform used to identify and validate new targets related to ecDNA biology. It utilizes a library of in vitro and in vivo models to differentiate between ecDNA positive and negative tumors [14][15] Key Findings and Learnings - **Clinical Insights**: Early clinical data from BBI-355 has shown responses in specific genetic markers, indicating potential for targeted therapy [17][18] - **Preclinical Data for BBI-940**: Demonstrated good tolerability and anti-tumor activity in various models, with a particular interest in breast cancer as a primary target [25][26] Competitive Landscape - **Current Position**: Boundless Bio does not face immediate competition for the specific kinesin target of BBI-940, as it is believed to be a first-in-class discovery [30] - **Broader Market**: Other companies are working on different kinesins, but Boundless Bio's target is considered non-overlapping, potentially allowing for complementary therapies [31] Industry Trends - **Growing Interest in ecDNA**: The field has seen significant academic interest, with multiple publications and conferences dedicated to ecDNA research. Big Pharma is also showing interest, with companies like Amgen exploring ecDNA biology [35][36] Financial Overview - **Cash Position**: As of the last earnings report, Boundless Bio had approximately $117 million in cash, projected to last into 2028 [38]

Core Insights - Boundless Bio is a clinical-stage oncology company focused on developing therapies targeting extrachromosomal DNA (ecDNA) to treat oncogene amplified cancers [1][3] - The company will participate in a fireside chat at the Piper Sandler 37th Annual Healthcare Conference on December 3, 2025 [2] Company Overview - Boundless Bio is dedicated to addressing the unmet needs of patients with oncogene amplified tumors, which are linked to ecDNA, found in 14% to 17% of cancer patients [3] - The company is developing ecDNA-directed therapeutic candidates, including BBI-355, an oral selective inhibitor of checkpoint kinase 1 (CHK1), and BBI-825, an oral selective inhibitor of ribonucleotide reductase (RNR) [3] - These candidates are currently being evaluated in the phase 1/2 POTENTIATE clinical trial for patients with oncogene amplified cancers [3] - Additionally, Boundless Bio is conducting IND-enabling studies for BBI-940, a potentially first-in-class orally bioavailable selective Kinesin degrader [3] - The company is headquartered in San Diego, CA [3]

Financial Position - The company has an accumulated deficit of $246.8 million as of September 30, 2025, and expects to continue incurring losses for the foreseeable future [98]. - As of September 30, 2025, the company had cash, cash equivalents, and short-term investments of $117.6 million, expected to fund operations into the first half of 2028 [99][100]. - The company reported an accumulated deficit of $246.8 million as of September 30, 2025, and anticipates continued significant operating losses in the foreseeable future [132]. - The company has no committed sources of capital and plans to finance future cash needs primarily through equity offerings and debt financings [134]. Revenue Generation - The company has not generated any revenue to date and does not expect to do so until regulatory approval for its ecDTx is obtained [101]. - The company expects to incur significant commercialization expenses if regulatory approval for any ecDTx is obtained, impacting future financial performance [132]. Fundraising and Cash Flow - The company raised a total of $353.8 million to fund operations, including $100.0 million from its IPO in April 2024 [99]. - The company entered into an Open Market Sale Agreement in April 2025, allowing for potential future sales of common stock [130]. - Net cash used in operating activities was $36.6 million for the nine months ended September 30, 2025, a decrease from $45.3 million in the same period of 2024, primarily due to reduced third-party spending [136]. - Financing activities provided net cash of $0.1 million during the nine months ended September 30, 2025, significantly lower than $89.7 million in the same period of 2024, primarily due to IPO proceeds [139]. Operating Expenses - Research and development (R&D) expenses decreased to $10.7 million for the three months ended September 30, 2025, down from $14.1 million in 2024, a reduction of $3.4 million [121]. - General and administrative (G&A) expenses were $4.5 million for the three months ended September 30, 2025, compared to $4.6 million in 2024, reflecting a decrease of $0.2 million [122]. - Total operating expenses for the three months ended September 30, 2025, were $15.1 million, down from $18.7 million in 2024, a decrease of $3.6 million [120]. - For the nine months ended September 30, 2025, R&D expenses totaled $35.0 million, down from $42.0 million in 2024, a decrease of $6.9 million [126]. - G&A expenses for the nine months ended September 30, 2025, increased to $14.5 million from $13.0 million in 2024, an increase of $1.5 million [127]. - Total operating expenses for the nine months ended September 30, 2025, were $49.6 million, down from $55.0 million in 2024, a decrease of $5.4 million [125]. - Other income, net for the three months ended September 30, 2025, was $1.3 million, down from $2.2 million in 2024, a decrease of $0.9 million [123]. Clinical Trials and Development - The company opened the BBI-355/BBI-825 combination arm of the POTENTIATE trial for enrollment in Q3 2025, with initial proof-of-concept data expected within the existing cash runway timeline [93]. - The company plans to submit an IND for BBI-940 in the first half of 2026 and anticipates delivering initial proof-of-concept clinical data within the existing cash runway timeline [94]. - The company has developed an ecDNA diagnostic called ECHO to detect ecDNA in patient tumor samples, currently used in the POTENTIATE trial [95]. - The company discontinued the monotherapy arm and combination arms of BBI-355 with third-party therapies in the POTENTIATE trial based on initial data, focusing on BBI-355 in combination with BBI-825 [96]. - The company has incurred substantial costs related to clinical trials, preclinical studies, and research and development activities, with cash flow fluctuations expected based on these activities [136]. Risks and Uncertainties - The company faces significant risks from macroeconomic and regulatory uncertainties that could adversely affect its operations and ability to raise capital [105][106]. - The company remains classified as an emerging growth company, allowing it to delay compliance with certain accounting standards until it meets specific revenue or market value thresholds [145]. Lease Obligations - Future minimum lease payment obligations under a non-cancellable lease agreement total $71.6 million as of September 30, 2025, with base rent payments commencing in July 2025 [140].

Financial Performance - Cash, cash equivalents, and short-term investments totaled $117.6 million as of September 30, 2025, down from $152.1 million at the end of 2024[14] - Net loss for Q3 2025 was $13.9 million, an improvement from a net loss of $16.5 million in Q3 2024[9] - The accumulated deficit increased to $246.8 million as of September 30, 2025, compared to $201.5 million at the end of 2024[14] - Total operating expenses for Q3 2025 were $15.1 million, down from $18.7 million in Q3 2024[13] Research and Development - Research and Development (R&D) expenses were $10.7 million for Q3 2025, a decrease of 24% compared to $14.1 million for the same period in 2024[9] - The company expects to submit an investigational new drug (IND) application for BBI-940 and initiate a first-in-human Phase 1 clinical trial in the first half of 2026[5] - Enrollment is ongoing in the BBI-355/BBI-825 combination arm of the POTENTIATE trial, with initial proof-of-concept clinical data expected within the existing cash runway timeline[3] - The company is developing BBI-940, a potentially first-in-class, orally bioavailable, selective Kinesin degrader targeting ecDNA segregation and inheritance[4] General and Administrative Expenses - General and Administrative (G&A) expenses were $4.5 million for Q3 2025, slightly down from $4.6 million in Q3 2024[9] Cash Position - The company has $118 million in cash to support operations into the first half of 2028[1]

Core Insights - Boundless Bio is advancing its pipeline focused on extrachromosomal DNA (ecDNA) to develop innovative therapies for oncogene-amplified cancers, with ongoing enrollment in the BBI-355/BBI-825 combination arm of the POTENTIATE trial and plans to initiate a first-in-human clinical trial for BBI-940 in the first half of 2026 [2][3][5] Financial Highlights - As of September 30, 2025, the company reported cash, cash equivalents, and short-term investments totaling $117.6 million, which is expected to support operations into the first half of 2028 [7][10] - Research and Development (R&D) expenses for Q3 2025 were $10.7 million, a decrease from $14.1 million in Q3 2024, while General and Administrative (G&A) expenses were $4.5 million, slightly down from $4.6 million in the same period [7][10] - The net loss for Q3 2025 was $13.9 million, compared to a net loss of $16.5 million for Q3 2024, indicating an improvement in financial performance [7][10] Research and Development Updates - The POTENTIATE clinical trial is actively enrolling patients for the combination of BBI-355 and BBI-825, with initial proof-of-concept clinical data expected within the existing cash runway timeline [3][4] - BBI-940, a novel Kinesin degrader targeting ecDNA segregation, is on track for investigational new drug submission, with a first-in-human clinical trial anticipated to start in the first half of 2026 [1][5]

Core Insights - Boundless Bio is a clinical-stage oncology company focused on developing therapies for oncogene amplified cancers through the study of extrachromosomal DNA (ecDNA) [2] Group 1: Company Overview - Boundless Bio is dedicated to addressing the unmet needs of patients with oncogene amplified tumors, which are linked to ecDNA observed in 14% to 17% of cancer patients [2] - The company is developing ecDNA-directed therapeutic candidates, including BBI-355, a selective CHK1 inhibitor, and BBI-825, a selective RNR inhibitor [2] - Boundless Bio is conducting a phase 1/2 clinical trial named POTENTIATE to evaluate the combination of BBI-355 and BBI-825 in patients with oncogene amplified cancers [2] Group 2: Upcoming Presentation - Boundless Bio will present a poster at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics from October 22-26, 2025, in Boston, MA [1] - The presentation will focus on the synergistic oral combination of BBI-825 and BBI-355 targeting unique dependencies of oncogene amplified cancers [1] - The poster session is scheduled for October 23, 2025, from 12:30 PM to 4:00 PM ET, located at Level 2, Exhibit Hall D [1]