Cue Biopharma(CUE) - 2025 Q3 - Quarterly Report

Drug Development and Clinical Trials - The company is preparing to file an investigational new drug (IND) application for CUE-401 in the second quarter of 2026, with human safety data expected in the second half of 2026 and proof-of-concept data in the second half of 2027[162]. - CUE-401 has shown a 50% overall response rate (ORR) in treatment-naïve patients when combined with KEYTRUDA, significantly outperforming the 19% ORR observed with KEYTRUDA alone[173]. - The company has dosed a total of 80 patients in the CUE-101 Phase 1b study, with database lock preparations expected to be completed in the fourth quarter of 2025[168]. - The CUE-500 series, including CUE-501, is being developed to target and deplete autoreactive B cells, with a collaboration agreement established with Boehringer Ingelheim International GmbH[164]. - The company anticipates that CUE-401 and the CUE-500 series represent potential breakthrough therapeutic opportunities for significant patient populations[166]. - The company has established collaborations for the development of CUE-101 and CUE-102 with ImmunoScape Pte. Ltd., focusing on oncology applications[171]. - The company plans to seek regulatory approvals for drug product candidates upon successful completion of clinical trials[233]. - The company will continue preclinical development of CUE-401 and the CUE-500 series, excluding CUE-501 which has been licensed to BI[233]. Financial Performance and Revenue - The company incurred $0.9 million in fees related to the amendment of the Einstein License in the second quarter of 2025[180]. - No revenue was recognized from the LG Chem Collaboration Agreement for the three and nine months ended September 30, 2025, with a total of $20.0 million recorded since the agreement's inception[186]. - The Ono Collaboration and Option Agreement was terminated in March 2025, with the company having recognized $0.4 million in revenue for the nine months ended September 30, 2025[190]. - The company entered into a Collaboration and License Agreement with BI on April 10, 2025, receiving an upfront payment of $10.1 million and potential milestone payments of up to $345.0 million[193]. - For the three and nine months ended September 30, 2025, the company recognized $2.1 million and $5.1 million in revenue from the BI Collaboration and License Agreement, respectively[195]. - Collaboration revenue decreased by $1.2 million for the three months ended September 30, 2025, compared to the same period in 2024, primarily due to reduced revenue from the BI Collaboration[210]. - Collaboration revenue decreased by $2.2 million for the nine months ended September 30, 2025, compared to the same period in 2024[211]. Expenses and Losses - Research and development expenses for the nine months ended September 30, 2025, totaled $21.2 million, a decrease from $29.1 million in the same period of 2024[204]. - The company reported a net loss of $7.4 million for the three months ended September 30, 2025, compared to a net loss of $8.7 million for the same period in 2024[209]. - Total operating expenses for the nine months ended September 30, 2025, were $34.1 million, down from $39.6 million in the same period of 2024[209]. - General and administrative expenses increased by $2.2 million for the nine months ended September 30, 2025, primarily due to increased professional fees and a one-time employee severance payment[213]. - Research and development expenses decreased by $7.9 million for the nine months ended September 30, 2025, primarily due to decreases in clinical trial costs and employee compensation[215]. - Interest income decreased by $0.7 million for the nine months ended September 30, 2025, due to lower interest earned on cash and cash equivalents[216]. Cash Flow and Funding - Net cash used in operating activities totaled $20.6 million for the nine months ended September 30, 2025, a decrease of $6.7 million compared to the same period in 2024[229]. - Net cash used in investing activities totaled $6.9 million for the nine months ended September 30, 2025, compared to net cash provided of less than $0.1 million in 2024[230]. - Net cash provided by financing activities totaled $16.8 million for the nine months ended September 30, 2025, an increase of $5.6 million compared to the same period in 2024[231]. - As of September 30, 2025, the company believes existing cash and marketable securities will fund operations into the third quarter of 2026, but substantial additional capital will be needed for future operations[227]. - The company recorded net proceeds from the April 2025 underwriting agreement of approximately $18.0 million after deducting expenses[226]. - The company has sold an aggregate of 11,504,093 shares under the ATM Sales Agreement for proceeds of $42.2 million since its inception[221]. - The company anticipates needing to raise additional capital or incur additional indebtedness to fund operations in the near term[235]. - The ability to raise additional funds will depend on financial, economic, and market conditions, which are largely outside the company's control[235]. - The company may need to delay, reduce, or eliminate product development or commercialization efforts if unable to raise additional funds[235]. - The company expects to finance cash needs through a combination of equity offerings, debt financings, collaborations, and grants[237]. - The company may incur additional legal, accounting, and other expenses in operating as a public company[233]. - The company may seek to access capital markets whenever conditions are favorable, even without an immediate need for additional capital[239]. Licensing and Collaboration Agreements - The company regained rights to the CUE-101 program from LG Chem, with future payments contingent on specific scenarios, while LG Chem retains rights to the CUE-102 program[185]. - ImmunoScape exercised its option to license CUE-100 series molecules, with the company receiving $5.0 million in the fourth quarter of 2025[197]. - The company has no material changes to its contractual obligations and commitments as described in its Annual Report[241].