Cue Biopharma Reports Second Quarter 2020 Results and CUE-101 Phase 1 Dose Escalation Trial Updates

On August 31, 2020 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 body, provided a business update for the second quarter of 2020 (Press release, Cue Biopharma, AUG 31, 2020, View Source [SID1234608297]).

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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 highly encouraged with the emerging data sets from this ongoing study, have completed dosing cohorts 4 and 5 in July and August, and recently were cleared by the Safety Review Committee to begin dosing cohort 6, at 4mg/kg."

"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," said Anish Suri, chief scientific officer and president of Cue Biopharma.

Second-Quarter 2020 Financial Results

The Company had steady collaboration revenue of approximately $1.1 million for the three months ended June 30, 2020 and 2019.

Research and development expenses were $8.1 million and $6.9 million for the three months ended June 30, 2020 and 2019, respectively. This increase of approximately $1.3 million was due primarily to the increase in laboratory and drug manufacturing costs, stock-based compensation and clinical expenses, offset by a decrease in travel expenses as the COVID-19 pandemic hampered business travel throughout the second quarter.

General and administrative expenses were $3.9 million and $3.4 million for the three months ended June 30, 2020 and 2019, respectively. This increase of approximately $0.5 million was due primarily to stock-based compensation and legal fees offset by a decrease in travel expenses for the second quarter.

"As of June 30, 2020, we had approximately $85 million in cash and marketable securities which will allow us to support the continued development of our Immuno-STAT platform, including the clinical development of CUE-101, into 2022," said Kerri-Ann Millar, chief financial officer of Cue Biopharma, Inc.

Recent News & Business Updates

Advancing CUE-101 into cohort 6 in its ongoing multicenter, open-label, dose escalation Phase 1 monotherapy trial for patients with human papilloma virus-positive recurrent/metastatic head and neck squamous cell carcinoma (HPV+ HNSCC).

Extended cash runway during the second quarter through an ATM equity offering sales agreement for aggregate proceeds of $42.4 million, net of commissions paid, with Stifel Nicolaus & Company, Inc., who acted as sales agent.

Announced a peer-reviewed paper titled "Mechanistic dissection of the PD-L1:B7-1 co-inhibitory immune complex" in PLOS ONE. The study results describe novel functional interactions that regulate responses mediated by the B7 family of immune checkpoint molecules and the generation and evaluation of libraries of these molecules with directed mutations providing novel biological properties with potential therapeutic applications.

Entered into a research collaboration agreement with Dr. Michael Dustin and the University of Oxford to determine the molecular mechanisms underlying the activity of its IL-2 based CUE-100 series Immuno-STAT (Selective Targeting and Alteration of T cells) Biologics.

Appointed Kerri-Ann Millar as Chief Financial Officer after serving as the company’s principal finance and accounting officer since 2018.
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, Monday, August 31 at 4:30 p.m. EDT.