On November 14, 2022 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate tumor-specific T cells directly within the patient’s body, reported third quarter 2022 financial results (Press release, Cue Biopharma, NOV 14, 2022, View Source [SID1234624104]). The Company will host a business update call in conjunction with its financial results press release on November 14, 2022.
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Recent Business Updates
Announced a $30 million private investment in public equity (PIPE) financing with certain accredited investors in which the company agreed to sell 7,656,966 shares of its common stock and, in lieu of shares of common stock to certain investors, pre-funded warrants to purchase an aggregate of 1,531,440 shares of common stock, and, in each case, accompanying warrants to purchase an aggregate of up to 9,188,406 additional shares of common stock (or Pre-Funded Warrants). The transaction is expected to close on or about November 16, 2022, subject to the satisfaction of customary closing conditions.
Presented new positive data from the ongoing Phase 1 trials of CUE-101 in combination with pembrolizumab (KEYTRUDA) and as a monotherapy for recurrent/metastatic HPV+ head and neck squamous cell carcinoma (r/m HNSCC) at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 37th Annual Meeting on November 10, 2022.
Key data highlights from the dose escalation and patient expansion portion of the Phase 1 trial evaluating CUE-101 at the recommended Phase 2 dose in combination with pembrolizumab include a 40% overall response rate (ORR) and a 70% clinical benefit rate (CBR) in first line (1L) r/m HNSCC patients treated with CUE-101, with 16 evaluable patients to date.
Median overall survival (mOS) approaching greater than 12 months in third line and beyond (3L+) patients treated with CUE-101 monotherapy, which is 50% greater than current standard of care (SOC) with anti-PD-1 therapy in second line (2L) patients.
"With our anticipated strengthened financial position and with bolstered confidence from the recently reported clinical update at SITC (Free SITC Whitepaper), we are able to focus on core strategic initiatives to further enhance our competitive positioning to optimize shareholder value," said Daniel Passeri, chief executive officer of Cue Biopharma.
Kerri-Ann Millar, chief financial officer of Cue Biopharma, added, "We are pleased to have announced our private placement, which would extend our cash runway into 2024 upon closing and further strengthen our ability to assess the CUE-101 data readouts from both the Phase 1 monotherapy and combination clinical trials and remain on track to define a potential registrational CUE-101 monotherapy trial by mid-2023."
Third-Quarter 2022 Financial Results
The Company reported collaboration revenue of approximately $68 thousand and $2.4 million for the three months ended September 30, 2022 and 2021, respectively.
Research and development expenses were $7.6 million and $11.3 million for the three months ended September 30, 2022 and 2021, respectively. The decrease in research and development expenses of $3.7 million was primarily due to a decrease in laboratory and drug substance manufacturing costs, employee and Scientific and Clinical Advisory Board compensation, other professional fees, licensing fees, and rent.
General and administrative expenses were $3.5 million and $4.1 million for the three months ended September 30, 2022 and 2021, respectively. The decrease in general and administrative expense of $0.6 million was primarily due to a decrease in stock-based compensation expense related to executive management, professional and consulting fees, and employee and board compensation incurred in the third quarter of 2022 as compared to the same period in 2021.