BOSTON, Aug. 19, 2024 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (NASDAQ:CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells, provided a business and financial update for the second quarter 2024.
Recent Business Highlights
Delivered oral presentation on updated data from ongoing Phase 1(b) trial of CUE-101 as a first line (1L) therapy in human papillomavirus positive (HPV+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC), with standard of care (SOC) checkpoint inhibitor (CPI) KEYTRUDA® (pembrolizumab) and as a monotherapy in second line and beyond (2L+) HPV+ R/M HNSCC, as well as a poster presentation on CUE-102 in Wilms' Tumor 1 (WT1) positive cancers at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting held in June.
Further advanced autoimmune program CUE-401, partnered with Ono Pharmaceutical, Ltd., and CUE-501, our lead CUE-500 series asset.
Programs are designed to address significant unmet medical need in large patient populations across numerous autoimmune and inflammatory diseases
Preclinical data has progressed well with consistent positive activity in multiple disease models
Initiated strategic prioritization of autoimmune programs to focus upon near-term and intermediate value creation potential, to enable optimization and reduction of capital requirements, while retaining oncology programs, CUE-101 and CUE-102, as promising clinical data further matures.
Positive observations as updated data continues to mature from ongoing oncology clinical trials, CUE-101 and CUE-102.
CUE-101 in combination with pembrolizumab in 1L R/M HNSCC, as of August 4, 2024, demonstrated an objective response rate (ORR) of 46% in all patients with combined positive score (CPS) ≥1 and 50% ORR with CPS <20, median progression free survival (mPFS) of 5.8 months and median overall survival (mOS) of 21.8 months
CUE-101 monotherapy in 2L+ HPV+ R/M HNSCC demonstrated mOS of 20.8 months vs. mOS of 7.5 and 8.4 months observed in trials in 2L patients with two different CPIs: OPDIVO® (nivolumab) and pembrolizumab, respectively
CUE-102 monotherapy in late-stage refractory metastatic cancers has been well tolerated and to date, has demonstrated dose-dependent increases in exposure and activation and expansion of WT1-specific T cells with observed anti-tumor activity in two gastric and ovarian patients, as well as disease control in several tumor types in multiple patients in the dose escalation Phase 1 trial
"We had a highly productive second quarter with promising clinical data continuing to mature from our ongoing oncology trials further supporting our belief that CUE-101, as our lead representative CUE-100 program, has the potential to establish a new standard of care for HPV+ HNSCC patients," said Daniel Passeri, chief executive officer of Cue Biopharma. "These observations, combined with the ongoing advancements of our prioritized autoimmune programs and the recent implementation of a highly focused, strategic business model underscoring our objectives to proactively manage and mitigate capital access risk, support the transformational potential of our Immuno-STAT™ platform to accomplish our mission of developing breakthrough immunotherapies to establish a new standard of care in the treatment of cancer and autoimmune disease."
Second Quarter 2024 Financial Results The Company reported collaboration revenue of $2.7 million and $1.4 million for the three months ended June 30, 2024 and 2023, respectively. The increase was due to the timing of revenue earned from the collaboration and option agreement with Ono Pharmaceutical Co., Ltd.
Research and development expenses were $9.5 million and $10.7 million for the three months ended June 30, 2024 and 2023, respectively. The decrease was primarily due to a decrease in research and laboratory costs and compensation expense.
General and administrative expenses were $3.5 million and $4.2 million for the three months ended June 30, 2024 and 2023, respectively. The decrease was primarily due to decreases in professional fees, employee compensation, overhead, and stock-based compensation expense.
The Company reported collaboration revenue of $4.4 million and $1.6 million for the six months ended June 30, 2024 and 2023, respectively. The increase was due to the timing of revenue earned from the collaboration and option agreement with Ono Pharmaceutical Co., Ltd.
Research and development expenses were $19.7 million and $20.0 million for the six months ended June 30, 2024 and 2023, respectively. The decrease was primarily due to a decrease in research and laboratory costs and stock-based compensation expense, partially offset by an increase in clinical expenses.
General and administrative expenses were $7.7 million and $8.4 million for the six months ended June 30, 2024 and 2023, respectively. The decrease was primarily due to decreases in professional fees and employee compensation. As of June 30, 2024, the Company had $30.0 million in cash and cash equivalents compared with $48.5 million as of June 30, 2023. We expect our current cash, cash equivalents, and marketable securities to fund operations through the second quarter of 2025.
Cue Biopharma, Inc.
Condensed Consolidated Statement of Operations and Comprehensive Loss(Unaudited)
(In thousands, except share and per share amounts)
Three Months EndedJune 30,
Six Months EndedJune 30,
2024
2023
2024
2023
Collaboration revenue
$
2,658
$
1,382
$
4,375
$
1,570
Operating expenses:
General and administrative
3,511
4,249
7,697
8,425
Research and development
9,530
10,650
19,729
