Boundless Bio Reports Third Quarter 2024 Financial Results and Business Highlights
Boundless Bio (BOLD) reported Q3 2024 financial results, highlighting progress in its clinical trials. The company maintains a strong cash position of $167.1 million, providing runway into Q4 2026. Key developments include ongoing enrollment in BBI-355 POTENTIATE and BBI-825 STARMAP trials, with initial proof-of-concept data expected in H2 2025. Q3 financials show R&D expenses of $14.1M (up from $11.6M in Q3 2023), G&A expenses of $4.6M (up from $3.3M), and a net loss of $16.5M (increased from $13.2M).
Boundless Bio (BOLD) ha riportato i risultati finanziari del terzo trimestre del 2024, evidenziando i progressi nei suoi studi clinici. L'azienda mantiene una solida posizione di liquidità di 167,1 milioni di dollari, garantendo così risorse fino al quarto trimestre del 2026. Tra gli sviluppi chiave ci sono l'arruolamento in corso degli studi BBI-355 POTENTIATE e BBI-825 STARMAP, con i dati iniziali di prova di concetto attesi per la seconda metà del 2025. I finanziamenti del terzo trimestre mostrano spese per R&D di 14,1 milioni di dollari (rispetto a 11,6 milioni nel terzo trimestre del 2023), spese generali e amministrative di 4,6 milioni (aumento rispetto a 3,3 milioni) e una perdita netta di 16,5 milioni (cresciuta rispetto a 13,2 milioni).
Boundless Bio (BOLD) informó los resultados financieros del tercer trimestre de 2024, destacando los avances en sus ensayos clínicos. La compañía mantiene una sólida posición de efectivo de 167,1 millones de dólares, lo que proporciona recursos hasta el cuarto trimestre de 2026. Los desarrollos clave incluyen la inscripción continua en los ensayos BBI-355 POTENTIATE y BBI-825 STARMAP, con datos iniciales de prueba de concepto esperados para la segunda mitad de 2025. Las finanzas del tercer trimestre muestran gastos de I+D de 14,1 millones de dólares (un aumento desde los 11,6 millones en el tercer trimestre de 2023), gastos generales de 4,6 millones (un aumento desde los 3,3 millones) y una pérdida neta de 16,5 millones (incrementada desde los 13,2 millones).
바운드리스 바이오 (BOLD)는 2024년 3분기 재무 결과를 보고하며 임상 시험에서의 발전을 강조했습니다. 이 회사는 1억 6,710만 달러의 강력한 현금 보유를 유지하고 있어 2026년 4분기까지 운영할 수 있는 기반을 마련하고 있습니다. 주요 개발 사항으로는 BBI-355 POTENTIATE 및 BBI-825 STARMAP 시험의 지속적인 등록이 있으며, 초기 개념 증명 데이터는 2025년 하반기 중에 예상됩니다. 3분기 재무는 2023년 3분기의 1,160만 달러에서 증가한 1,410만 달러의 R&D 비용, 330만 달러에서 증가한 460만 달러의 일반 관리 비용, 그리고 1320만 달러에서 증가한 1650만 달러의 순손실을 나타냅니다.
Boundless Bio (BOLD) a publié ses résultats financiers du troisième trimestre 2024, soulignant des progrès dans ses essais cliniques. L'entreprise conserve une solide position de liquidités de 167,1 millions de dollars, ce qui assure un financement jusqu'au quatrième trimestre 2026. Parmi les développements majeurs figurent l'inscription en cours aux essais BBI-355 POTENTIATE et BBI-825 STARMAP, avec des données préliminaires de preuve de concept attendues pour la deuxième moitié de 2025. Les finances du troisième trimestre montrent des dépenses en R&D de 14,1 millions de dollars (en hausse par rapport à 11,6 millions au troisième trimestre 2023), des dépenses générales et administratives de 4,6 millions (en hausse par rapport à 3,3 millions) et une perte nette de 16,5 millions (en augmentation par rapport à 13,2 millions).
Boundless Bio (BOLD) berichtete über die finanziellen Ergebnisse des dritten Quartals 2024 und hob die Fortschritte in seinen klinischen Studien hervor. Das Unternehmen verfügt über eine starke Barreserve von 167,1 Millionen Dollar, die einen finanziellen Spielraum bis zum vierten Quartal 2026 bietet. Zu den wichtigen Entwicklungen gehören die laufende Rekrutierung für die Studien BBI-355 POTENTIATE und BBI-825 STARMAP, wobei erste Proof-of-Concept-Daten für die zweite Hälfte von 2025 erwartet werden. Die finanziellen Ergebnisse des dritten Quartals zeigen Forschungs- und Entwicklungsausgaben von 14,1 Millionen Dollar (ein Anstieg von 11,6 Millionen im dritten Quartal 2023), allgemeine und administrative Ausgaben von 4,6 Millionen Dollar (ein Anstieg von 3,3 Millionen) und einen Nettoverlust von 16,5 Millionen Dollar (eine Zunahme von 13,2 Millionen).
- Strong cash position of $167.1M providing extended runway into Q4 2026
- Clinical trials progressing with no new safety signals observed
- Development of proprietary ecDNA diagnostic ECHO showing positive validation data
- Increased net loss to $16.5M from $13.2M year-over-year
- R&D expenses increased 21.6% to $14.1M year-over-year
- G&A expenses rose 39.4% to $4.6M year-over-year
Insights
The Q3 financial results reveal a solid cash position of
The extended cash runway provides significant operational flexibility through key clinical milestones, particularly the anticipated proof-of-concept data in H2 2025 for both BBI-355 and BBI-825 programs. This financial positioning reduces near-term funding pressure and allows focus on clinical execution.
The parallel advancement of two distinct clinical programs targeting ecDNA biology represents a novel approach in oncology. The BBI-355 CHK1 inhibitor and BBI-825 RNR inhibitor programs are progressing with no new safety signals, while the development of the ECHO diagnostic tool marks a significant operational achievement for patient selection. The validation data presented at ESMO strengthens the company's position in ecDNA-focused precision oncology.
The expansion into a third program targeting kinesin demonstrates pipeline diversification within the ecDNA space. The anticipated proof-of-concept data in H2 2025 will be important in validating this innovative therapeutic approach for oncogene amplified cancers, an area with significant unmet medical need.
Enrollment progressing in BBI-355 POTENTIATE and BBI-825 STARMAP clinical trials, with initial proof-of-concept data expected in the second half of 2025
Cash position of
SAN DIEGO, Nov. 07, 2024 (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 provided business updates and reported financial results for the third quarter of 2024.
“The third quarter was marked by steady execution across the portfolio, with the POTENTIATE and STARMAP trials continuing to enroll patients,” said Zachary Hornby, President and Chief Executive Officer of Boundless Bio. "In September, together with our development partner, SOPHiA GENETICS, we presented analytical validation for our proprietary ecDNA diagnostic, ECHO, a critical first step in identifying ecDNA positive patients for our clinical programs. We are capitalized to advance our lead programs through proof-of-concept data and remain focused on delivering impactful results for our patients and stakeholders.”
Program Highlights and Upcoming Milestones
BBI-355, a novel, oral, potent, selective CHK1 inhibitor targeting replication stress for cancer patients with driver oncogene amplifications
- Enrollment is proceeding in the Phase 1/2 POTENTIATE clinical trial evaluating BBI-355 as a single agent and in combination with targeted therapies in patients with oncogene amplified solid tumors.
- No new safety signals have been observed.
- The company anticipates reporting initial clinical proof-of-concept data in the second half of 2025.
BBI-825, a novel, oral, potent, selective RNR inhibitor targeting ecDNA assembly and repair for cancer patients with resistance oncogene amplifications
- Enrollment continues to progress in the single agent, dose-escalation portion of the STARMAP clinical trial, with initial clinical proof-of-concept data expected in the second half of 2025.
ecDTx 3, a novel kinesin program involved in ecDNA segregation
- The company’s third ecDTx program, directed to a previously undrugged kinesin target essential for ecDNA segregation whose inhibition is synthetic lethal to ecDNA-enabled cancer cells, continues to advance through lead optimization.
ECHO, a proprietary diagnostic for detection of ecDNA amplified oncogenes
- In September, analytical validation data was presented at the European Society for Medical Oncology (ESMO) Congress for the company’s proprietary ecDNA diagnostic ECHO (ecDNA Harboring Oncogenes). ECHO is currently being used as a clinical trial assay to determine ecDNA status of patients enrolled in the BBI-355 POTENTIATE trial.
Third Quarter 2024 Financial Results
- Cash Position: Cash, cash equivalents, and short-term investments totaled
$167.1 million as of September 30, 2024. - R&D Expenses: Research and development (R&D) expenses were
$14.1 million for the third quarter of 2024 compared to$11.6 million for the same period in 2023. - G&A Expenses: General and administrative (G&A) expenses were
$4.6 million for the third quarter of 2024 compared to$3.3 million for the same period in 2023. - Net Loss: Net loss totaled
$16.5 million for the third quarter of 2024 compared to$13.2 million for the same period in 2023.
About BBI-355
Boundless Bio’s lead ecDNA-directed therapy (ecDTx), BBI-355, is a novel, oral, selective small molecule inhibitor of checkpoint kinase 1 (CHK1) being studied in the ongoing, first-in-human, Phase 1/2 POTENTIATE clinical trial (NCT05827614) in cancer patients with oncogene amplifications. CHK1 is a master regulator of cells’ response to replication stress (RS). RS is elevated in cancer cells with oncogene amplification, including on ecDNA, and, because of this, represents a key vulnerability of those cells. BBI-355 was designed to exploit the elevated RS in ecDNA-enabled oncogene amplified cancer cells by disrupting proper CHK1 function in regulating RS and thereby facilitating catastrophic RS to preferentially kill cancer cells relative to healthy cells.
About BBI-825
Boundless Bio’s second ecDTx, BBI-825, is a novel, oral, selective small molecule inhibitor of ribonucleotide reductase (RNR) being studied in the ongoing, first-in-human, Phase 1/2 STARMAP clinical trial (NCT06299761) in colorectal cancer patients with BRAFV600E or KRASG12C mutations and resistance gene amplifications. In preclinical studies, BBI-825 demonstrated low double digit nanomolar RNR inhibition and tumor growth inhibition, including regressions, in both the prevention and treatment of amplification-mediated resistance in mitogen-activated protein kinase (MAPK) pathway-activated tumors. RNR is the rate-limiting enzyme responsible for cellular de novo synthesis of deoxynucleotide triphosphates (dNTPs), the building blocks of DNA, and is essential to the assembly and repair of ecDNA. BBI-825 was shown to dysregulate ecDNA-reliant cancer cell dNTP pools, deplete ecDNA, and was synthetic lethal in multiple oncogene amplified preclinical cancer models.
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 more than
For more information, visit www.boundlessbio.com. Follow us on LinkedIn and X.
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 potential to achieve catalysts and long-term patient impact; the timing of expected data readouts; the sufficiency of our cash position to fund operations through initial clinical proof-of-concept data readouts and into the fourth quarter of 2026; the potential safety and therapeutic benefits of our ecDTx in treating patients with oncogene amplified cancers; the potential clinical validity and utility of our ecDNA diagnostic ECHO; and the potential for one or more of our ecDTx, if approved, to be the first ecDNA-directed therapy. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, 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; results from preclinical studies or early clinical trials not necessarily being predictive of future results; analytical validation of an ecDNA diagnostic not necessarily being predictive of its clinical validity and utility; potential delays in the commencement, enrollment, data readouts or completion of clinical trials or preclinical studies; 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; efforts to streamline operations may not produce the efficiencies expected; 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 quarterly report on Form 10-Q for the quarter ended March 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
| BOUNDLESS BIO, INC. | ||||||||||||||||||||||||||
| Condensed Financial Information | ||||||||||||||||||||||||||
| (Unaudited) | ||||||||||||||||||||||||||
| Condensed Statements of Operations Data: | Three Months Ended September 30, | Nine Months Ended September 30, | ||||||||||||||||||||||||
| (In thousands, except per share amounts) | 2024 | 2023 | 2024 | 2023 | ||||||||||||||||||||||
| Operating expenses: | ||||||||||||||||||||||||||
| Research and development | $ | 14,089 | $ | 11,645 | $ | 41,953 | $ | 32,223 | ||||||||||||||||||
| General and administrative | 4,626 | 3,308 | 13,036 | 8,777 | ||||||||||||||||||||||
| Total operating expenses | 18,715 | 14,953 | 54,989 | 41,000 | ||||||||||||||||||||||
| Loss from operations | (18,715 | ) | (14,953 | ) | (54,989 | ) | (41,000 | ) | ||||||||||||||||||
| Other income, net: | ||||||||||||||||||||||||||
| Interest income | 2,174 | 1,748 | 5,977 | 3,662 | ||||||||||||||||||||||
| Other income, net | 32 | 32 | 97 | 48 | ||||||||||||||||||||||
| Total other income, net | 2,206 | 1,780 | 6,074 | 3,710 | ||||||||||||||||||||||
| Net loss | $ | (16,509 | ) | $ | (13,173 | ) | $ | (48,915 | ) | $ | (37,290 | ) | ||||||||||||||
| Net loss per share, basic and diluted | $ | (0.74 | ) | $ | (10.71 | ) | $ | (3.22 | ) | $ | (30.89 | ) | ||||||||||||||
| Weighted-average shares used in calculation | 22,254 | 1,230 | 15,204 | 1,207 | ||||||||||||||||||||||
| Condensed Balance Sheet Data: | September 30, | December 31, | ||||||||||||||||||||||||
| (In thousands) | 2024 | 2023 | ||||||||||||||||||||||||
| Cash, cash equivalents, and short-term investments | $ | 167,135 | $ | 120,752 | ||||||||||||||||||||||
| Total assets | $ | 175,093 | $ | 129,894 | ||||||||||||||||||||||
| Total liabilities | $ | 10,010 | $ | 9,359 | ||||||||||||||||||||||
| Convertible preferred stock | $ | - | $ | 247,617 | ||||||||||||||||||||||
| Accumulated deficit | $ | (185,024 | ) | $ | (136,109 | ) | ||||||||||||||||||||
| Total stockholders' equity (deficit) | $ | 165,083 | $ | (127,082 | ) | |||||||||||||||||||||
| Working capital (1) | $ | 160,439 | $ | 114,845 | ||||||||||||||||||||||
| __________ | ||||||||||||||||||||||||||
| (1) We define working capital as current assets less current liabilities. | ||||||||||||||||||||||||||
FAQ
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