Cue Biopharma(US:CUE)2023-05-08 16:00Financial Performance - Collaboration revenue for the three months ended March 31, 2023, was $187,000, compared to $1,000 in the same period of 2022[36]. - Total operating expenses for Q1 2023 were $13.567 million, a decrease of 10.98% from $15.238 million in Q1 2022[36]. - The net loss for Q1 2023 was $13.109 million, compared to a net loss of $14.255 million in Q1 2022, reflecting a 8.05% improvement[36]. - The net loss per common share for Q1 2023 was $0.29, compared to $0.44 in Q1 2022[36]. - Cash used in operating activities was $10.8 million, compared to $11.6 million in the prior year, indicating a reduction of approximately 6.4%[39]. - The company reported net cash provided by investing activities of $15.0 million, primarily from the redemption of short-term investments[39]. - Cash and cash equivalents at the end of the period totaled $56.3 million, down from $68.1 million at the end of the previous year[39]. - The total stockholders' equity as of March 31, 2023, was $55,017,000, compared to $65,683,000 as of December 31, 2022[87]. - The company has incurred recurring losses and negative cash flows from operations since inception, highlighting the need for additional capital to finance operations and R&D[91]. Research and Development - Research and development expenses for Q1 2023 were $9.391 million, down from $10.082 million in Q1 2022, indicating a 6.86% reduction[36]. - The company is focused on developing a novel class of injectable biologics aimed at treating various diseases, with ongoing clinical trials[41]. - The company is prioritizing resources on the CUE-100 series in response to current financial market challenges[203]. - Preliminary clinical data for the lead drug candidate, CUE-101, shows promise in treating cancer, with ongoing trials aimed at demonstrating its effectiveness[203]. - The CUE-100 series utilizes engineered IL-2 for selective activation of tumor-specific T cells, potentially addressing a broad range of cancers[203]. - Promising preclinical data has been observed for the potential application of the Immuno-STAT platform in treating autoimmune diseases[203]. - The company is in various stages of clinical and preclinical development for its drug product candidates[203]. Strategic Collaborations - The company entered into a strategic collaboration agreement with Ono Pharmaceutical Co., Ltd., which includes an upfront payment of $3.0 million and potential milestone payments up to approximately $220 million[160][161]. - The Company received a $3.0 million upfront payment from Ono for R&D activities related to CUE-401, with additional reimbursement for costs capped at $2.1 million in the first 18 months[188]. - The Company is eligible to receive up to $400 million in research, development, regulatory, and sales milestones from LG Chem, along with tiered single-digit percentage royalties on net sales[185]. - A strategic collaboration with Ono Pharmaceuticals was established in February 2023 to develop CUE-401 for autoimmune disease treatment through regulatory T cell induction[203]. Stock and Equity - The weighted average common shares outstanding for Q1 2023 were 44,652,353, an increase from 32,636,383 in Q1 2022[36]. - The total number of common stock warrants increased to 9,188,406 as of March 31, 2023, up from 851,969 in 2022, indicating significant growth in potential equity[84]. - Stock options outstanding increased to 7,044,599 as of March 31, 2023, with a weighted average exercise price of $8.66[147]. - The company recognized stock-based compensation expenses of $1,998,000 for the three months ended March 31, 2023[87]. - The company recognized approximately $794,000 in stock-based compensation related to RSU activity for the three months ended March 31, 2022[150]. Debt and Financial Obligations - The company has a loan agreement that requires compliance with certain operating covenants, impacting its financial flexibility[53]. - Total long-term debt as of March 31, 2023, is $7,077,000, with a current portion of $2,963,000[144]. - Interest expense related to the Term Loans for the three months ended March 31, 2023, was $330,417, compared to $21,389 for the same period in 2022[143]. - The Term Loans bear an interest rate of 10.25% as of March 31, 2023, based on the prime rate plus 2.25%[143]. - The company is required to maintain unrestricted cash in accounts at the lender equal to the lesser of all cash or $20,000,000 as part of the Loan Agreement[143]. Operational Highlights - The company has not sold any shares under the October 2021 ATM Agreement during the three months ended March 31, 2023, maintaining proceeds of approximately $23.6 million from previous sales[43]. - The company incurred approximately $1.0 million in stock-based compensation for the three months ended March 31, 2023[39]. - The company recorded approximately $3,000 in amortization expense for its trademark for both the three months ended March 31, 2023, and 2022[96]. - The company recorded short and long-term research and development liabilities of approximately $2,521,000 and $445,000, respectively, as of March 31, 2023[162]. - Total lease payments for the Company amount to $9,479,000, with a present value of lease payments at $8,665,000 after applying a discount of $814,000[171].