BBI-355 Phase 1/2 POTENTIATE trial ongoing in patients with oncogene amplified cancers, with initial proof of concept data expected in the second half of 2025 Novel Kinesin program progressing toward development candidate nomination by mid-2025, with IND submission expected in the first half of 2026 With a $152 million cash position at the end of 2024, Boundless projects operating runway into 2027 SAN DIEGO, March 27, 2025 (GLOBE NEWSWIRE) -- Boundless Bio (Nasdaq: BOLD), a clinical-stage oncology company i ...

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]

Core Viewpoint - Boundless Bio, Inc. (BOLD) has experienced a significant decline of 19.5% over the past four weeks, but it is now in oversold territory, suggesting a potential turnaround as analysts expect better earnings than previously predicted [1]. Group 1: Stock Performance and Indicators - The stock has faced excessive selling pressure, leading to its current oversold status [1]. - The Relative Strength Index (RSI) for BOLD is at 28.72, indicating that the heavy selling may be exhausting itself, which could lead to a price rebound [5]. - A stock is generally considered oversold when its RSI falls below 30, which is a common threshold for identifying potential reversals [2]. Group 2: Earnings Estimates and Analyst Consensus - There is a strong consensus among sell-side analysts that earnings estimates for BOLD have increased by 1.2% over the last 30 days, which typically correlates with price appreciation [6]. - BOLD holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate revisions and EPS surprises, further supporting the potential for a turnaround [7].

Company Overview - Boundless Bio is a clinical-stage oncology company focused on developing therapies targeting extrachromosomal DNA (ecDNA) to treat oncogene amplified cancers, which affect over 14% of cancer patients [3] - The company is headquartered in San Diego, CA and aims to address significant unmet needs in cancer therapeutics [3] Product Development - Boundless Bio is developing its first ecDNA-directed therapy (ecDTx), BBI-355, an oral inhibitor of checkpoint kinase 1 (CHK1), currently in a Phase 1/2 clinical trial for patients with oncogene amplified cancers [3] - The second ecDTx, BBI-825, is an oral inhibitor of ribonucleotide reductase (RNR) being evaluated in a Phase 1/2 clinical trial for colorectal cancer patients with BRAFV600E or KRASG12C mutations and resistance gene amplifications [3] - The company is also advancing an additional program (ecDTx 3) through preclinical development and discovery using its Spyglass platform [3] Upcoming Events - Zachary Hornby, President and CEO of Boundless Bio, will participate in Piper Sandler's 36th Annual Healthcare Conference on December 4, 2024, at 3:30 p.m. ET in New York, NY [1][2] - A live and archived webcast of the session will be available on Boundless Bio's website [2]

Financial Performance - The company completed its initial public offering (IPO) in April 2024, selling 6,250,000 shares for gross proceeds of $100.0 million, raising a total of $353.6 million by September 30, 2024[130]. - As of September 30, 2024, the company had cash, cash equivalents, and short-term investments totaling $167.1 million, which is expected to fund operations into the fourth quarter of 2026[130]. - The company recognized incremental non-cash stock-based compensation expense of $857,000 due to option repricing, with $34,000 recognized during the three and nine months ended September 30, 2024[139][140]. - As of September 30, 2024, unrecognized compensation cost related to outstanding time-based options was $20.1 million, expected to be recognized over a weighted-average period of 2.7 years[143]. - The weighted-average grant date fair value of options granted during the three months ended September 30, 2024, was $7.25, compared to $3.23 in the same period of 2023[145]. Research and Development - The company is advancing its third ecDTx program, targeting a kinesin essential for ecDNA segregation, with an Investigational New Drug application (IND) expected in the first half of 2026[127]. - The company has preclinically validated multiple additional ecDNA targets and initiated drug discovery efforts against these targets, retaining global rights for all programs[128]. - The company expects general and administrative (G&A) expenses to increase substantially as it expands headcount to support R&D and potential commercialization activities[136]. Operations and Infrastructure - The company recorded a right-of-use (ROU) asset of $45.8 million and a related lease liability of $45.3 million in November 2024[148]. - The company plans to rely on third parties for the manufacture of its ecDTx, maintaining an efficient infrastructure without investing in its own manufacturing facilities[131].

Financial Performance - Cash position as of September 30, 2024, is $167.1 million, providing an operating runway into the fourth quarter of 2026[6] - Net loss for Q3 2024 totaled $16.5 million, compared to a net loss of $13.2 million in Q3 2023, indicating a 25% increase in losses[6] - Total operating expenses for Q3 2024 were $18.7 million, compared to $15.0 million in Q3 2023, marking an increase of 25.5%[13] - Accumulated deficit as of September 30, 2024, was $185.0 million, compared to $136.1 million at the end of 2023[13] Research and Development - Research and development (R&D) expenses for Q3 2024 were $14.1 million, up from $11.6 million in Q3 2023, representing a 21.5% increase[6] - Initial proof-of-concept data for BBI-355 and BBI-825 clinical trials is expected in the second half of 2025[3][4] - The company is advancing its third ecDTx program, ecDTx 3, through lead optimization[4] General and Administrative Expenses - General and administrative (G&A) expenses for Q3 2024 were $4.6 million, compared to $3.3 million in Q3 2023, reflecting a 39.4% increase[6] Assets and Financial Position - Total assets as of September 30, 2024, were $175.1 million, up from $129.9 million at the end of 2023[13] Clinical Trials and Diagnostics - ECHO, the proprietary diagnostic for detecting ecDNA amplified oncogenes, is currently being used in the BBI-355 POTENTIATE trial[5]