On November 17, 2020 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells within the patient’s body, reported a business update for the third quarter of 2020 (Press release, Cue Biopharma, NOV 17, 2020, View Source [SID1234608289]).
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"We are very pleased with the progress we continue to make advancing CUE-101 through the ongoing Phase 1 monotherapy dose escalation trial," said Daniel Passeri, chief executive officer of Cue Biopharma. "We are encouraged by the datasets to date from this ongoing study, have completed dosing cohort 6, at 4mg/kg and were recently cleared by the Safety Review Committee to begin dosing cohort 7, at 8mg/kg."
Anish Suri, chief scientific officer and president of Cue Biopharma, added, "We believe that we remain well-positioned for continued execution of our development plans for our lead asset CUE-101, which is representative of our IL-2 based CUE-100 series, and the continued build-out of our pipeline via our proprietary protein engineering approach, as also exemplified by recent scientific presentations at the SITC (Free SITC Whitepaper) meeting last week."
Third Quarter 2020 Financial Results
Collaboration revenue was $704,000 and $984,000 for the three months ended September 30, 2020 and 2019, respectively.
Research and development expenses were $7.5 million and $5.3 million for the three months ended September 30, 2020 and 2019, respectively. This increase of approximately $2.2 million was due primarily to an increase in clinical trial activity, drug manufacturing costs, and stock-based compensation expense, offset by a decrease in travel expenses during the third quarter of 2020 as the COVID-19 pandemic continued to hamper business travel throughout the quarter.
General and administrative expenses were $3.3 million and $2.8 million for the three months ended September 30, 2020 and 2019, respectively. This increase of approximately $0.5 million was due primarily to increases in stock-based compensation and legal fees offset by a decrease in travel expenses for the third quarter of 2020.
"As of September 30, 2020, we had approximately $91.8 million in cash, cash equivalents and marketable securities, which we believe will allow us to support the clinical development of our lead asset CUE-101 into the second quarter of 2022," said Kerri-Ann Millar, chief financial officer of Cue Biopharma.
Recent News & Business Updates
Presented three posters highlighting the company’s clinical and pipeline progress at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 35th Anniversary Annual Meeting (SITC 2020). The posters include a clinical update on CUE-101, the lead drug candidate from the IL-2 based CUE-100 series and data supporting the potential of the Immuno-STAT (Selective Targeting and Alteration of T cells) platform to selectively engage and modulate targeted T cells within the body in a manner that could address a broad range of indications.
Entered into an amendment to the Global License and Collaboration agreement with LG Chem that extended the deadline for LG Chem to exercise its option for an additional Immuno-STAT program from November 6, 2020 to April 30, 2021.
Appointed Tamar Howson to the board of directors. Ms. Howson brings broad corporate and business development experience to the board, having held executive leadership positions in several global biopharmaceutical and pharmaceutical companies as well as her extensive board service.
Presented preclinical data focused on the in vivo detection of tumor antigen-specific T cells in a peer-reviewed paper published in Nature Methods titled, "In vivo detection of antigen-specific CD8 T cells by immuno-positron emission tomography." The study was co-authored by Steven C. Almo, Ph.D., co-founder of Cue Biopharma, professor and chair of biochemistry, professor of physiology & biophysics and the Wollowick Family Foundation chair in multiple sclerosis and immunology at Albert Einstein College of Medicine and Hidde Ploegh, Ph.D., a renowned expert in molecular immunology and a member of the program in cellular and molecular medicine at Boston Children’s Hospital.
Extended cash runway during the third quarter of 2020 through sales of shares of common stock under an ATM equity offering sales agreement for aggregate proceeds of $14.3 million, net of commissions paid, with Stifel Nicolaus & Company, Inc., who acted as sales agent.
Members of the Cue Biopharma executive management team will provide an update on the ongoing Phase 1 clinical trial of CUE-101 for the treatment of HPV+ HNSCC, technology platforms and pipeline progress, as well as updates on its strategic objectives and anticipated milestones today, Tuesday, November 17 at 4:30 p.m. EST.