Cue Biopharma Q2 2024 Financial Results and Business Highlights

BOSTON, Aug. 19, 2024 – Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical firm focusing on developing innovative therapeutic biologics intended to engage and modulate disease-specific T cells, shared a business and financial update for the second quarter of 2024.

Recent Business Highlights

Cue Biopharma presented new data from its ongoing Phase 1(b) trial of CUE-101, used as a first-line therapy for human papillomavirus positive (HPV+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) in combination with the standard of care checkpoint inhibitor KEYTRUDA® (pembrolizumab). Additionally, it presented data on the CUE-101 monotherapy in second-line and beyond (2L+) HPV+ R/M HNSCC and a poster on CUE-102 in Wilms’ Tumor 1 (WT1) positive cancers at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting in June.

The company has continued to advance its autoimmune program, CUE-401, in partnership with Ono Pharmaceutical, Ltd., along with CUE-501, the lead asset in the CUE-500 series. These programs aim to address significant unmet medical needs across various autoimmune and inflammatory diseases. Preclinical data for these programs have shown consistent positive activity in multiple disease models.

Cue Biopharma has initiated strategic prioritization of its autoimmune programs to focus on near-term and intermediate value creation potential. This strategic move is intended to optimize and reduce capital requirements while maintaining oncology programs CUE-101 and CUE-102, as promising clinical data continue to mature.

Clinical Trial Progress

The company reported positive observations from its ongoing oncology clinical trials of CUE-101 and CUE-102. Specifically, CUE-101 combined with pembrolizumab in first-line R/M HNSCC showed an objective response rate (ORR) of 46% in all patients with a combined positive score (CPS) ≥1 and a 50% ORR for those with CPS <20. The median progression-free survival (mPFS) was 5.8 months, and the median overall survival (mOS) was 21.8 months. The CUE-101 monotherapy in second-line and beyond HPV+ R/M HNSCC demonstrated an mOS of 20.8 months compared to 7.5 and 8.4 months in other trials using OPDIVO® (nivolumab) and pembrolizumab, respectively.

CUE-102 monotherapy in late-stage refractory metastatic cancers has been well-tolerated. It exhibited dose-dependent increases in exposure and activation and expansion of WT1-specific T cells, showing anti-tumor activity in two gastric and ovarian cancer patients and disease control in several tumor types in multiple patients in the dose-escalation Phase 1 trial.

Management Commentary

"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 has the potential to establish a new standard of care for HPV+ HNSCC patients," stated Daniel Passeri, chief executive officer of Cue Biopharma. He highlighted the ongoing advancements of their prioritized autoimmune programs and the recent implementation of a focused, strategic business model to manage and mitigate capital access risk, supporting the transformational potential of their Immuno-STAT™ platform.

Second Quarter 2024 Financial Results

Cue Biopharma reported collaboration revenue of $2.7 million for the three months ended June 30, 2024, up from $1.4 million in the same period in 2023. This increase was attributed to the timing of revenue earned from the collaboration and option agreement with Ono Pharmaceutical Co., Ltd.

Research and development expenses decreased to $9.5 million for the three months ended June 30, 2024, from $10.7 million in the same period in 2023, primarily due to reduced research and laboratory costs and compensation expense. General and administrative expenses also decreased to $3.5 million from $4.2 million, mainly due to lower professional fees, employee compensation, overhead, and stock-based compensation expense.

For the six months that ended June 30, 2024, the company reported collaboration revenue of $4.4 million, compared to $1.6 million in the same period in 2023. Research and development expenses were $19.7 million, slightly down from $20.0 million in the same period in 2023. General and administrative expenses were $7.7 million, down from $8.4 million.

As of June 30, 2024, Cue Biopharma had $30.0 million in cash and cash equivalents, compared to $48.5 million as of June 30, 2023. The company expects its current cash, cash equivalents, and marketable securities to fund operations through the second quarter of 2025.

Cue Biopharma continues to develop its novel class of injectable biologics designed to selectively engage and modulate disease-specific T cells, leveraging its Immuno-STAT™ platform to harness the body's intrinsic immune system without the adverse effects of broad systemic immune modulation. Headquartered in Boston, Massachusetts, the company is led by an experienced management team and an independent Board of Directors with deep expertise in immunology and immuno-oncology.

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