Financial Performance - For the nine months ended September 30, 2025, BBOT incurred a net loss of $95.2 million, with an accumulated deficit of $317.8 million[140]. - BBOT incurred a net loss of $74.3 million for the year ended December 31, 2024[140]. - Net loss for the three months ended September 30, 2025, was $44.8 million, a 158% increase from a net loss of $17.3 million in the same period of 2024[169]. - For the nine months ended September 30, 2025, total operating expenses increased by 74% to $102.4 million from $59.0 million in 2024[176]. - Total operating expenses increased by 150% to $49.2 million from $19.7 million in the same period of 2024[169]. - Research and development expenses rose by 96% to $35.1 million for the three months ended September 30, 2025, compared to $17.9 million for the same period in 2024[170]. - General and administrative expenses surged by 696% to $14.1 million for the three months ended September 30, 2025, up from $1.8 million in 2024[169]. - Research and development expenses for the nine months ended September 30, 2025, increased by 55% to $83.1 million from $53.6 million in 2024[177]. - General and administrative expenses increased by $13.9 million, from $5.4 million for the nine months ended September 30, 2024, to $19.3 million for the nine months ended September 30, 2025[178]. - Interest income for the three months ended September 30, 2025, increased by 39% to $3.4 million from $2.5 million in 2024[169]. - Interest income rose by $2.7 million, from $4.2 million for the nine months ended September 30, 2024, to $6.9 million for the nine months ended September 30, 2025[179]. - Net cash used in operating activities for the nine months ended September 30, 2025 was $71.7 million, compared to $40.0 million for the same period in 2024, reflecting an increase of $31.7 million[193][194]. - Net cash provided by financing activities was $384.0 million for the nine months ended September 30, 2025, including $373.5 million from reverse recapitalization and PIPE Financing[197]. - Cash, cash equivalents, and marketable securities totaled $468.3 million as of September 30, 2025, expected to meet cash requirements for at least twelve months[186]. Product Development - BBOT's lead product candidate, BBO-8520, demonstrated a 60% confirmed overall response rate in KRAS G12C NSCLC patients during Phase 1 trials[138]. - The company is currently enrolling the Phase 1 ONKORAS-101 trial for BBO-8520, with updated clinical data expected in Q1 2026[138]. - BBO-10203, another lead candidate, is designed to inhibit RAS-driven PI3Kα-AKT signaling and is currently in the Phase 1 BREAKER-101 trial, with initial data expected in H1 2026[139]. - BBOT has not generated any revenue from product candidates as of now[139]. - The increase in research and development expenses reflects a shift to contract manufacturing and clinical development activities related to product candidates[171]. Corporate Transactions - The de-SPAC transaction with Helix Acquisition Corp. II was completed on August 11, 2025, resulting in BBOT's common stock listing on Nasdaq[145]. - The PIPE Financing associated with the de-SPAC transaction raised approximately $260.9 million[146]. - The company plans to access capital resources through public or private equity offerings, debt financings, and collaborations in the future[187]. - The company expects to incur additional costs associated with operating as a public company following the de-SPAC Transaction[200]. - Future funding requirements will depend on various factors, including the success of product candidates in clinical development and regulatory approval[201]. Liabilities and Obligations - BBOT incurred initial upfront fees of $1.8 million under the Additional Leidos Licenses and is obligated to make contingent milestone payments totaling up to $24.4 million by September 30, 2025[206]. - As of September 30, 2025, BBOT recorded a liability of $0.5 million for milestones achieved but unpaid, included in accrued research and development liabilities[206]. - BBOT is required to make contingent milestone payments totaling up to $21.1 million under the LLNS Agreements by September 30, 2025[209]. - General and administrative expenses for the nine months ended September 30, 2025, included $8.3 million for services provided by BridgeBio Pharma[221]. - BBOT recognized $0.2 million in research and development expenses for the three months ended September 30, 2025, related to BridgeBio Pharma services[221]. Economic Risks - BBOT's operations are subject to various economic risks, including inflation and geopolitical factors, which may impact its financial position[153]. - The fair value of common stock is derived from the public trading market following the de-SPAC Transaction[227]. - BBOT's operating expenses include significant amounts charged by or related to transactions with BridgeBio Pharma[217]. - As of September 30, 2025, BBOT did not have any off-balance sheet arrangements that materially affect its financial condition[211].
Helix Acquisition(HLXB) - 2025 Q3 - Quarterly Report