On May 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 first quarter 2021 (Press release, Cue Biopharma, MAY 17, 2021, View Source [SID1234608279]).
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"During the first quarter of 2021 and early second quarter, we continued to make significant progress advancing the Phase 1a/1b monotherapy trial of CUE-101 and continued development of our expanding pipeline and technology platforms, as well as enhancing 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 as well as describing the development implications for CUE-101 and potential of the CUE-100 series and Immuno-STAT platform, during the quarterly update call."
Kerri-Ann Millar, chief financial officer of Cue Biopharma, added, "We finished the first quarter of 2021 in a solid financial position which was further strengthened by the deployment of our at-the-market (ATM) common stock facility in April that enabled us to boost our cash position by an additional $10.4 million giving us operational runway into the fourth quarter of 2022."
Recent News & Business Updates
Reported PR in one patient and stable disease (SD) in five patients, confirmed by RECIST criteria, providing evidence of single-agent clinical activity of CUE-101 in the ongoing Phase 1 monotherapy dose escalation trial in late stage second-line and beyond patients with HPV+ recurrent/metastatic head and neck cancer, as well as evidence of both tumor-specific CD8+ T cell expansion and dose-dependent increases in NK cells.
Extended cash runway with sales in April of an aggregate of $10.4 million shares of our common stock pursuant to our ATM equity offering sales agreement with Stifel. As of April 30, 2021, we sold a cumulative total of 2,099,700 shares of common stock for aggregate net proceeds of $32.7M, net of commissions paid, under the sales agreement.
Initiated Phase 1 dose escalation clinical trial of CUE-101 in combination with Merck’s KEYTRUDA, an anti-PD-1 biologic agent, as first-line therapy in patients with advanced HPV16+ head and neck cancer.
Appointed renowned experts Abul K. Abbas, M.D., distinguished professor in pathology and former chair of the department of pathology at the University of California, San Francisco (UCSF) and Michael Kalos, Ph.D., managing director of Next Pillar Consulting, LLC and former executive vice president and head of research and development at ArsenalBio, to our Scientific Advisory Board (SAB).
First-Quarter 2021 Financial Results
The Company reported collaboration revenue of approximately $1.6 million and $0.9 million for the three months ended March 31, 2021 and 2020, respectively.
Research and development expenses were $9.8 million and $9.9 million for the three months ended March 31, 2021 and 2020, respectively. The decrease in research and development expenses of $0.9 million was primarily due to a decrease in laboratory and drug substance manufacturing costs as the clinical supply for our lead drug candidate, CUE-101, was produced during 2020, as well as a reduction in clinical and travel related expenses.
General and administrative expenses were $4.3 million and $4.0 million for the three months ended March 31, 2021 and 2020, respectively. The increase in general and administrative expense of $0.3 million was primarily due to an increase in stock-based compensation expense and legal fees incurred in the first quarter of 2021 as compared to the same period in 2020.