Cue Biopharma, Inc. Q1 FY2021 earnings call

Key Points

• CUE-101 Progress: CUE-101 is in a Phase 1 monotherapy trial for HPV positive head and neck squamous cell carcinoma, with a confirmed partial response in a refractory patient population. It shows potential as a monotherapy and in combination with pembrolizumab.
• Pipeline Updates: CUE-102 targets WT1; Neo-STAT addresses tumor heterogeneity; RDI-STATs target HLA loss escape; CUE-401 is for autoimmune diseases.
• Financials: Collaboration revenue increased to ~$1.6M in Q1 2021 vs ~$0.9M in Q1 2020. R&D expenses decreased to $9.8M, G&A expenses increased to $4.3M due to stock-based comp and legal fees. Ended Q1 with ~$73.3M in cash.

No detailed segment performance with product segments and revenue contribution provided in the transcript.

Forward-Looking Statements

• Plan to select recommended Phase 2 dose for CUE-101 monotherapy by mid-2021 for HPV positive second line and beyond head and neck squamous cell carcinoma.
• Expect initial Phase 1 results from CUE-101 and pembrolizumab combination study in the second half of 2021.
• Intend to initiate a neo adjuvant study to evaluate CUE-101's effect on the tumor microenvironment in the second half of 2021.

Risks

• Factors from the company's 10-K filing that could materially affect forward-looking statements, including clinical trial uncertainties, regulatory hurdles, and potential differences between actual results and projections.

Q: Tom Shrader asked about T cell levels and Tregs program.

A: Anish Suri discussed T cell detection in patients, the neo adjuvant study's importance, and the Tregs strategy for autoimmune diseases.

Q: Mark Breidenbach inquired about patient details and T cell counts.

A: Ken Pienta and Anish Suri provided responses on the patient's status and T cell fold increases.

Q: Reni Benjamin asked about patient progression and T cell counts.

A: Ken Pienta and Anish Suri answered on the patient's stability and T cell fold increases observed.

Q: Stephen Willey asked about registrational path and pipeline prioritization.

A: Daniel Passeri and Ken Pienta discussed the registration path and pipeline prioritization based on emerging data.

Q: Brian Skorney asked about PD data and dose relationship.

A: Anish Suri discussed PD metrics like NK cell and E7-specific T cell increases and their relevance to dose.

Q: Zhiqiang Shu asked about safety, combination trial synergies, and Neo-STAT.

A: Anish Suri and Ken Pienta answered on safety aspects, combination trial benefits, and Neo-STAT design for tumor peptide conjugation.