Earnings release
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CUE BIOPHARMA Cue Biopharma Reports Second Quarter 2021 Results , Recent Data Updates of CUE - 101 Phase 1 Dose Escalation and Expansion Study , Platform Progress and Business Highlights August 17 , 2021 CAMBRIDGE , Mass . , Aug. 17 , 2021 ( GLOBE NEWSWIRE ) 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 , provided a business and clinical progress update for the second quarter 2021 . " 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 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 . Collaboration revenue Operating expenses : General and administrative Research and development Total operating expenses Loss from operations Other income : Interest income , net Net Loss Cue Biopharma , Inc. Selected Consolidated Statement of Operations Data ( in thousands ) Net loss per common share - basic and diluted Weighted average common shares outstanding - basic and diluted $ $ $ A LA $ Three Months Ended June 30 , 2021 2,739 $ 4,280 8,762 13,042 ( 10,303 ) $ 24 ( 10,279 ) $ ( 0.33 ) 31,233,794 $ 2020 1,075 3,898 8,119 12,017 ( 10,942 ) 109 ( 10,833 ) ( 0.38 ) 28,221,537