On August 17, 2021 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells within the patient’s body, reported a business and clinical progress update for the second quarter 2021 (Press release, Cue Biopharma, AUG 17, 2021, View Source [SID1234608273]).
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"During the second quarter 2021, we continued to make significant clinical progress advancing our IL-2 based CUE-100 series, represented by the Phase 1a/1b monotherapy trial of CUE-101 and combination-therapy trial with KEYTRUDA (pembrolizumab). In addition, we have continued with the development and expansion of our pipeline programs and technology platforms, and also enhanced our capital resources," said Daniel Passeri, chief executive officer of Cue Biopharma. "Importantly, we recently reported a confirmed partial response (PR) in a patient from our ongoing Phase 1 monotherapy dose escalation trial of CUE-101 and look forward to providing further details on this patient response during the quarterly update call. Our Phase 1 monotherapy dose escalation and expansion study is now in dose expansion and our combination study with pembrolizumab continues in dose escalation. During the call, we will also highlight the development implications for CUE-101 and potential of the CUE-100 series and Immuno-STAT platform."
Kerri-Ann Millar, chief financial officer of Cue Biopharma, added, "We continue to be in a solid financial position and deployed our at-the-market (ATM) common stock facility during the second quarter to extend the anticipated operational runway further into the fourth quarter of 2022."
Recent News & Business Updates
Reported first patient dosed in the Part B expansion of its CUE-101 Phase 1 monotherapy clinical trial in HPV+ second line and beyond head and neck squamous cell carcinoma (HNSCC), at the recommended Phase 2 dose of 4mg/kg.
Presented preclinical data on CUE-401, the Company’s first autoimmune drug product candidate from the CUE-400 series, at the 2021 Federation of Clinical Immunology Societies (FOCIS) Annual Meeting.
Second Quarter 2021 Financial Results
The Company reported collaboration revenue of approximately $2.7 million and $1.1 million for the three months ended June 30, 2021 and 2020, respectively. The increase in collaboration revenue of $1.6 million was primarily due to additional research and development and contract manufacturing activities in preparation of an investigational new drug (IND) filing for its second drug product candidate from the IL-2 based CUE-100 series, CUE-102, planned for the first half of 2022.
Research and development expenses were $8.8 million and $8.1 million for the three months ended June 30, 2021 and 2020, respectively. The increase in research and development expenses of $0.7 million was primarily due to an increase in laboratory and drug substance manufacturing costs and clinical expenses.
General and administrative expenses were $4.3 million and $3.9 million for the three months ended June 30, 2021 and 2020, respectively. The increase in general and administrative expense of $0.4 million was primarily due to an increase in stock-based compensation expense and legal fees incurred in the second quarter of 2021 as compared to the same period in 2020.