On May 10, 2022 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the patient’s body, reported first quarter 2022 financial results (Press release, Cue Biopharma, MAY 10, 2022, View Source [SID1234614231]). The Company will not host a business update call in conjunction with its financial results press release.
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Recent Business Updates
Extended cash runway with an aggregate of $23.6 million from the sale of 3,593,407 shares of our common stock pursuant to our at-the-market (ATM) equity offering sales agreement with Jefferies LLC. As of March 31, 2022, the Company sold 2,396,013 shares of common stock under the October 2021 ATM Agreement for proceeds of approximately $17.6 million net of commissions paid, excluding transaction expenses, and in April 2022 sold an additional 1,197,394 shares of common stock for proceeds of approximately $6.0 million, net of commissions paid, excluding transaction expenses.
Completed enrollment of 20 patients at the recommended Phase 2 dose of 4mg/kg of the Phase 1b monotherapy trial of CUE-101 for the treatment of HPV16-driven recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) in second line and beyond treatment-refractory patients. To date, CUE-101 has demonstrated a favorable tolerability profile as well as encouraging anti-tumor clinical activity and what appears to be an emerging trend of enhanced overall survival (OS).
Completed dose escalation phase of CUE-101 in combination with Merck’s KEYTRUDA, an anti-PD-1 biologic agent, as first-line therapy in patients with advanced HPV16+ HNSCC. Patient enrollment has begun in the expansion phase at the recommended Phase 2 dose of 4mg/kg of CUE-101.
"Through a focused and strategic deployment of resources during the first quarter of 2022, we have made significant progress advancing the IL-2-based CUE-100 series for oncology, as well as strengthening our financial position," said Daniel Passeri, chief executive officer of Cue Biopharma. "As reported, we recently completed the patient expansion phase of the monotherapy Phase 1b clinical trial of CUE-101 and the dose escalation phase of the CUE-101 Phase 1 combination trial with KEYTRUDA. We are very pleased with our clinical trial progress to date and have enhanced confidence in the emerging data supporting the potential of our CUE-100 series pipeline in immuno-oncology through targeted and selective stimulation of the patient’s immune system against cancer."
Kerri-Ann Millar, chief financial officer of Cue Biopharma, added, "We continue to be in a solid financial position as we remain disciplined in our resource deployment and adroit in our response to the challenges of the current biotech capital markets. Accessing our ATM common stock facility during the first four months of 2022 allowed us to extend the anticipated operational runway further into the third quarter of 2023 which we anticipate will enable us to assess the data readouts from both our Phase 1 monotherapy and combination clinical trials of CUE-101."
First-Quarter 2022 Financial Results
The Company reported collaboration revenue of approximately $1.0 million and $1.6 million for the three months ended March 31, 2022 and 2021, respectively.
Research and development expenses were $10.1 million and $9.8 million for the three months ended March 31, 2022 and 2021, respectively. The increase in research and development expenses of $0.3 million was primarily due to an increase 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 $5.2 million and $4.3 million for the three months ended March 31, 2022 and 2021, respectively. The increase in general and administrative expense of $0.9 million was primarily due to an increase in stock-based compensation expense, professional and consulting fees, and employee and board compensation incurred in the first quarter of 2022 as compared to the same period in 2021.