Cue Biopharma, Inc. Q3 FY2023 earnings call

• Daniel Passeri emphasized the strategic positioning and core competitive advantages of the Immuno-STAT platform, highlighting features like creating a therapeutic index for IL-2 by selectively targeting tumor-specific T-cells. Matteo Levisetti discussed clinical data from CUE-101 and CUE-102 trials, including antitumor efficacy in various cancer patients, durable responses, and combination activity with pembrolizumab. Anish Suri detailed the preclinical pipeline of Immuno-STAT candidates targeting mutated KRAS, MAGE A4, PRAME, etc., and platform applications in autoimmune and inflammatory diseases. Kerri-Ann Millar provided financials for Q3 2023, noting collaboration revenue, R&D expenses, and cash position.

No detailed financial breakdown by product segments with revenue contribution % was provided in the transcript. The focus was on clinical and platform aspects rather than traditional product segment financial performance.

• Kerri-Ann Millar stated that current cash and cash equivalents are expected to fund operations through 2024. - Anticipated milestones include defining the registration path for CUE-101 and multiple clinical milestones with clinical candidates across several solid tumor types.

No significant discussion of risks and operational failures was evident in the provided transcript.

Q: Regarding CUE-101, what is the format of the communication with the FDA regarding defining a registration path? And what gives confidence in pursuing multiple tumor types for CUE-102 besides high WT1 expression?

A: Daniel Passeri mentioned initial discussions with the FDA regarding registrational trial design for CUE-101's monotherapy in second line and beyond, with consideration of partnering objectives. Matteo Levisetti added that CUE-102 has a favorable tolerability profile and observed signs of antitumor activity in multiple indications, with stable disease and potential partial responses in various advanced cancers being encouraging.

Q: For the patient with a PR in CUE-101, how many doses were received and details on low CPS patients in the combination study?

A: Matteo Levisetti said the patient with stable disease for 24 months received 24 months of treatment with regimen adjustments. Regarding low CPS patients in the combination study, the median PFS is maturing, with several patients having ongoing objective responses and the median PFS close to six months.

Q: What other antigens are being targeted, and interest from potential partners?

A: Anish Suri discussed targeting mutated KRAS, MAGE A4, PRAME, etc. Potential partners are interested in primary cancer drivers, with opportunities in driver antigens, onco-fetal antigens, and Neo-STAT for multiple antigens, leveraging the platform's efficiencies.

Q: Details on partnerships and moving into pivotal studies?

A: Daniel Passeri mentioned considering partnering strategies for flexibility while continuing drug development. Partnerships are not necessary for pivotal studies, but current market dynamics and limited resources influence strategic collaboration assessments.