Boundless Bio Reports Fourth Quarter and Full Year 2024 Financial Results and Business Highlights
Boundless Bio (BOLD) has reported its Q4 and full year 2024 financial results, highlighting progress in its oncology pipeline targeting extrachromosomal DNA (ecDNA) in cancer treatment. The company's lead candidate, BBI-355, is advancing in the Phase 1/2 POTENTIATE trial, with initial proof-of-concept data expected in H2 2025.
Key financial metrics include a strong cash position of $152.1 million as of December 31, 2024, providing runway into 2027. Full-year 2024 results showed R&D expenses of $55.3 million and G&A expenses of $18.0 million, with a net loss of $65.4 million.
The company is also progressing with its novel Kinesin program, targeting ecDNA segregation, with development candidate nomination expected by mid-2025 and IND submission planned for H1 2026. Additionally, Boundless appointed Robert Doebele, M.D., Ph.D., as Chief Medical Officer in February 2025.
Boundless Bio (BOLD) ha riportato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando i progressi nel suo pipeline oncologico mirato al DNA extracromosomico (ecDNA) nel trattamento del cancro. Il candidato principale dell'azienda, BBI-355, sta avanzando nella sperimentazione clinica di Fase 1/2 POTENTIATE, con i primi dati di prova di concetto attesi nel secondo semestre del 2025.
I principali indicatori finanziari includono una solida posizione di liquidità di 152,1 milioni di dollari al 31 dicembre 2024, garantendo un margine di operatività fino al 2027. I risultati dell'intero anno 2024 hanno mostrato spese per R&S di 55,3 milioni di dollari e spese generali e amministrative di 18,0 milioni di dollari, con una perdita netta di 65,4 milioni di dollari.
L'azienda sta anche proseguendo con il suo innovativo programma Kinesin, mirato alla segregazione dell'ecDNA, con la nomina del candidato per lo sviluppo prevista entro la metà del 2025 e la presentazione dell'IND pianificata per il primo semestre del 2026. Inoltre, Boundless ha nominato Robert Doebele, M.D., Ph.D., come Chief Medical Officer nel febbraio 2025.
Boundless Bio (BOLD) ha informado sobre sus resultados financieros del cuarto trimestre y del año completo 2024, destacando los avances en su cartera oncológica dirigida al ADN extracromosómico (ecDNA) en el tratamiento del cáncer. El candidato principal de la compañía, BBI-355, avanza en el ensayo clínico Fase 1/2 POTENTIATE, con los primeros datos de prueba de concepto esperados para el segundo semestre de 2025.
Los principales indicadores financieros incluyen una sólida posición de efectivo de 152.1 millones de dólares al 31 de diciembre de 2024, proporcionando un margen de operación hasta 2027. Los resultados del año completo 2024 mostraron gastos de I+D de 55.3 millones de dólares y gastos generales y administrativos de 18.0 millones de dólares, con una pérdida neta de 65.4 millones de dólares.
La compañía también está avanzando con su nuevo programa Kinesin, dirigido a la segregación del ecDNA, con la nominación del candidato de desarrollo esperada para mediados de 2025 y la presentación del IND planeada para el primer semestre de 2026. Además, Boundless nombró a Robert Doebele, M.D., Ph.D., como Director Médico en febrero de 2025.
Boundless Bio (BOLD)는 2024년 4분기 및 연간 재무 결과를 보고하며, 암 치료에서 엑스트라 크로모솜 DNA(ecDNA)를 목표로 하는 종양학 파이프라인의 진전을 강조했습니다. 회사의 주요 후보인 BBI-355는 1/2상 POTENTIATE 임상시험에서 진행 중이며, 초기 개념 증명 데이터는 2025년 하반기에 예상됩니다.
주요 재무 지표로는 2024년 12월 31일 기준 1억 5,210만 달러의 강력한 현금 보유량이 있으며, 이는 2027년까지 운영을 지원합니다. 2024년 전체 결과는 R&D 비용이 5,530만 달러, 일반 관리 비용이 1,800만 달러이며, 순손실은 6,540만 달러로 나타났습니다.
회사는 또한 ecDNA 분리에 초점을 맞춘 새로운 Kinesin 프로그램을 진행 중이며, 개발 후보 지명은 2025년 중반으로 예상되며, IND 제출은 2026년 상반기로 계획되고 있습니다. 또한, Boundless는 2025년 2월에 Robert Doebele, M.D., Ph.D.를 최고 의학 책임자로 임명했습니다.
Boundless Bio (BOLD) a publié ses résultats financiers du quatrième trimestre et de l'année complète 2024, mettant en avant les progrès de son pipeline oncologique ciblant l'ADN extracromosomique (ecDNA) dans le traitement du cancer. Le candidat principal de l'entreprise, BBI-355, avance dans l'essai clinique de Phase 1/2 POTENTIATE, avec des données initiales de preuve de concept attendues au second semestre 2025.
Les indicateurs financiers clés comprennent une solide position de trésorerie de 152,1 millions de dollars au 31 décembre 2024, offrant une marge de manœuvre jusqu'en 2027. Les résultats de l'année complète 2024 ont montré des dépenses de R&D de 55,3 millions de dollars et des dépenses générales et administratives de 18,0 millions de dollars, avec une perte nette de 65,4 millions de dollars.
L'entreprise progresse également avec son nouveau programme Kinesin, ciblant la ségrégation de l'ecDNA, avec une nomination de candidat au développement prévue d'ici mi-2025 et une soumission d'IND prévue pour le premier semestre 2026. De plus, Boundless a nommé Robert Doebele, M.D., Ph.D., au poste de directeur médical en février 2025.
Boundless Bio (BOLD) hat seine finanziellen Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 veröffentlicht und dabei Fortschritte in seiner Onkologie-Pipeline hervorgehoben, die sich auf extrachromosomale DNA (ecDNA) in der Krebsbehandlung konzentriert. Der Hauptkandidat des Unternehmens, BBI-355, befindet sich in der Phase 1/2 POTENTIATE-Studie, wobei erste Machbarkeitsdaten für das zweite Halbjahr 2025 erwartet werden.
Wichtige finanzielle Kennzahlen umfassen eine starke Liquiditätsposition von 152,1 Millionen Dollar zum 31. Dezember 2024, die einen finanziellen Spielraum bis 2027 bietet. Die Ergebnisse für das gesamte Jahr 2024 zeigten F&E-Ausgaben von 55,3 Millionen Dollar und allgemeine Verwaltungskosten von 18,0 Millionen Dollar, mit einem Nettoverlust von 65,4 Millionen Dollar.
Das Unternehmen macht auch Fortschritte mit seinem neuartigen Kinesin-Programm, das auf die Segregation von ecDNA abzielt, mit der Nominierung eines Entwicklungskandidaten, die bis Mitte 2025 erwartet wird, und einer IND-Einreichung, die für das erste Halbjahr 2026 geplant ist. Darüber hinaus ernannte Boundless im Februar 2025 Robert Doebele, M.D., Ph.D., zum Chief Medical Officer.
- Strong cash position of $152.1M providing runway into 2027
- BBI-355 Phase 1/2 trial progressing with data expected H2 2025
- Novel Kinesin program advancing with clear development timeline
- Increased net loss to $65.4M in 2024 from $49.4M in 2023
- R&D expenses increased 30% to $55.3M in 2024
- G&A expenses rose 48% to $18.0M in 2024
Insights
Boundless Bio's Q4 2024 financial report reveals a solid cash position of
The company's R&D expenses increased to
The expected proof-of-concept data for BBI-355 in H2 2025 represents the most significant near-term catalyst, though investors should note this is still 12+ months away. The novel Kinesin program targeting ecDNA segregation adds pipeline depth but remains in preclinical stages with IND submission not expected until H1 2026.
Dr. Doebele's appointment as CMO brings valuable experience in biology-based, tumor-agnostic development strategies, which aligns well with Boundless Bio's platform approach targeting ecDNA biology across multiple cancer types.
Boundless Bio's focus on extrachromosomal DNA (ecDNA) biology represents a distinctive approach in oncology. Their lead candidate BBI-355 targets CHK1 to exploit replication stress in oncogene-amplified cancers, a mechanism that theoretically addresses the fundamental biology driving certain aggressive tumors.
The ongoing POTENTIATE trial employs their proprietary ECHO diagnostic to detect ecDNA amplified oncogenes, potentially enabling better patient selection—a critical factor for targeted oncology success. This targeted approach could provide advantages in development, though clinical validation remains pending with data expected in H2 2025.
Their novel Kinesin program targets ecDNA segregation during cell division, addressing a different vulnerability in the same biological pathway. This multi-pronged approach to targeting ecDNA biology demonstrates platform potential rather than single-asset dependency.
The development timelines presented—candidate nomination by mid-2025 and IND submission in H1 2026 for the Kinesin program—align with standard development expectations for this class of therapeutics. The company appears to be executing according to industry-standard timelines without notable acceleration or delays in their pipeline progression.
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
SAN DIEGO, March 27, 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 financial results and business highlights for the fiscal quarter and full year ended December 31, 2024.
“We made important strides in 2024 as we became a public company and continued to advance BBI-355, our oral, selective CHK1 inhibitor in the Phase 1/2 POTENTIATE trial in patients with oncogene amplified cancers, and we look forward to reporting preliminary proof-of-concept data in the second half of this year,” said Zachary Hornby, President and CEO of Boundless Bio. “Additionally, we have continued to identify new targets and are advancing an oral degrader of a novel kinesin identified by our Spyglass platform. We are on track to nominate a development candidate for our Kinesin program by mid-year, with the intention to submit an IND in the first half of 2026. We look forward to the year ahead as we continue to advance our pipeline to address the significant unmet need in patients with oncogene amplified cancers.”
Research and Development Highlights and Upcoming Milestones
BBI-355, a novel, oral, potent CHK1 inhibitor designed to target replication stress in oncogene-amplified cancers
- Enrollment in the Phase 1/2 POTENTIATE clinical trial evaluating BBI-355 as a monotherapy and combination agent in patients with locally advanced or metastatic solid tumors with oncogene amplifications is ongoing.
- ECHO, a proprietary diagnostic for the detection of ecDNA amplified oncogenes, is in use in the POTENTIATE trial.
- Boundless expects to report preliminary clinical proof-of-concept safety and antitumor activity data in the second half of 2025.
Novel Kinesin program targeting ecDNA segregation and inheritance
- Boundless is advancing a preclinical program targeting a previously undrugged kinesin that is essential for proper ecDNA segregation and inheritance during cell division.
- Boundless expects to nominate a development candidate by mid-2025 and submit an investigational new drug application (IND) to the FDA in the first half of 2026.
Recent Corporate Highlights
- In February 2025, Boundless appointed Robert Doebele, M.D., Ph.D., as Chief Medical Officer. Dr. Doebele is a medical oncologist and previously served as Chief Medical Officer and Chief Scientific Officer at Rain Oncology, where he led the early and late-stage development of multiple oncology programs using biology-based, tumor-agnostic strategies.
Fourth Quarter and Full Year 2024 Financial Results
- Cash Position: Cash, cash equivalents, and short-term investments totaled
$152.1 million as of December 31, 2024. - Research and Development (R&D) Expenses: R&D expenses were
$13.3 million for the fourth quarter of 2024 and$55.3 million for the full year 2024, compared to$10.4 million and$42.6 million for the same periods in 2023. - General and Administrative (G&A) Expenses: G&A expenses were
$5.0 million for the fourth quarter of 2024 and$18.0 million for the full year 2024, compared to$3.4 million and$12.2 million for the same periods in 2023. - Net Loss: Net loss totaled
$16.4 million for the fourth quarter of 2024 and$65.4 million for the full year 2024, compared to$12.1 million and$49.4 million for the same periods in 2023.
About Boundless Bio
Boundless Bio is a clinical-stage oncology company dedicated to unlocking a new paradigm in cancer therapeutics to address the significant unmet need of patients with oncogene amplified tumors by targeting extrachromosomal DNA (ecDNA), a root cause of oncogene amplification observed in 14 to
Forward-Looking Statements
Boundless Bio cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include but are not limited to: the timing of expected preliminary clinical proof-of-concept data from the Phase 1/2 POTENTIATE trial, nomination of an ecDTx from the Kinesin program and submission of an IND for that ecDTx, the sufficiency of our cash position to fund operations and achievement of program milestones; and the potential therapeutic benefits of our ecDTx in treating patients with oncogene amplified cancers. Our actual results and performance may differ materially from those expressed or implied in any forward-looking statement set forth in this press release due to numerous known and unknown risks and uncertainties, including, without limitation: we are early in our development efforts and our approach to discover and develop ecDTx directed against ecDNA in oncogene amplified cancers is novel and unproven; risks inherent in the business of discovering, developing, obtaining regulatory approval for, and commercializing drugs for use as human therapeutics and operating as an early clinical-stage company; we only have one ecDTx in clinical development and all of our other development efforts are in the discovery and preclinical development stage; results from preclinical studies or early clinical trials not necessarily being predictive of future results; potential delays in the commencement, enrollment, data readouts or completion of clinical trials or preclinical studies, or submission of an IND; final data from our clinical trials may be materially different from interim, topline or preliminary data we publish as more patient data become available and/or data undergo more comprehensive reviews and audit and verification procedures; analytical validation of our ecDNA diagnostic not necessarily being predictive of its clinical validity and utility; our dependence on third parties in connection with clinical trials, preclinical studies, ecDNA diagnostic development, and manufacturing; unfavorable results from clinical trials or preclinical studies; we may expend our limited resources to pursue a particular ecDTx and fail to capitalize on ecDTx with greater development or commercial potential; unexpected adverse side effects or inadequate efficacy of our ecDTx that may limit their development, regulatory approval, and/or commercialization; the potential for our programs and prospects to be negatively impacted by developments relating to our competitors, including the results of studies or regulatory determinations relating to our competitors; regulatory developments in the United States and foreign countries; disruptions in how the U.S. Food and Drug Administration (FDA) operates, including due to staff reductions, could result in longer review periods for our regulatory submissions and delay advancement of our ecDTx; we may use our capital resources sooner than we expect; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K for the year ended December 31, 2024 and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Investor Contacts:
Ben Flaum, Boundless Bio
bflaum@boundlessbio.com
Renee Leck, THRUST Strategic Communications
renee@thrustsc.com
Media Contact:
Carly Scaduto
carly@carlyscadutoconsulting.com
| BOUNDLESS BIO, INC. | |||||||||||||||
| Financial Information | |||||||||||||||
| Statements of Operations Data: | Three Months Ended December 31, | Year Ended December 31, | |||||||||||||
| (In thousands, except per share amounts) | 2024 | 2023 | 2024 | 2023 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 13,314 | $ | 10,414 | $ | 55,267 | $ | 42,637 | |||||||
| General and administrative | 4,964 | 3,382 | 18,000 | 12,159 | |||||||||||
| Total operating expenses | 18,278 | 13,796 | 73,267 | 54,796 | |||||||||||
| Loss from operations | (18,278 | ) | (13,796 | ) | (73,267 | ) | (54,796 | ) | |||||||
| Other income, net: | |||||||||||||||
| Interest income | 1,915 | 1,620 | 7,892 | 5,282 | |||||||||||
| Other income, net | (85 | ) | 32 | 12 | 80 | ||||||||||
| Total other income, net | 1,830 | 1,652 | 7,904 | 5,362 | |||||||||||
| Net loss | $ | (16,448 | ) | $ | (12,144 | ) | $ | (65,363 | ) | $ | (49,434 | ) | |||
| Net loss per share, basic and diluted | $ | (0.74 | ) | $ | (9.76 | ) | $ | (3.85 | ) | $ | (40.65 | ) | |||
| Weighted-average shares used in calculation | 22,284 | 1,244 | 16,984 | 1,216 | |||||||||||
| Balance Sheet Data: | December 31, | December 31, | |||||||||||||
| (In thousands) | 2024 | 2023 | |||||||||||||
| Cash, cash equivalents, and short-term investments | $ | 152,114 | $ | 120,752 | |||||||||||
| Total assets | $ | 206,409 | $ | 129,894 | |||||||||||
| Total liabilities | $ | 55,767 | $ | 9,359 | |||||||||||
| Convertible preferred stock | $ | - | $ | 247,617 | |||||||||||
| Accumulated deficit | $ | (201,472 | ) | $ | (136,109 | ) | |||||||||
| Total stockholders' equity (deficit) | $ | 150,642 | $ | (127,082 | ) | ||||||||||
| Working capital (1) | $ | 146,255 | $ | 114,845 | |||||||||||
| __________ | |||||||||||||||
| (1) We define working capital as current assets less current liabilities. | |||||||||||||||
FAQ
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