CUE

• Implemented strategic restructuring to reduce capital requirements, enhance productivity via strategic partnerships, and mature clinical data for competitive positioning.
• Oncology: CUE-101 Phase 1(b) trial shows substantial survival prolongation in monotherapy and combination with KEYTRUDA; CUE-102 well-tolerated with preliminary anti-tumor activity.
• Autoimmune: CUE-401 in collaboration with Ono shows progress in lead candidate selection; CUE-501 targets B cell depletion with unique safety/efficacy profile.
• Platform: Immuno-STAT platform selectively modulates immune cells, clinically validated in oncology with promising preclinical data in autoimmunity.

• Oncology: Continued data maturation from CUE-101 and CUE-102 trials, with updated data to be presented at CITC in November.
• Autoimmune: Progress in selecting lead candidate for CUE-401; ongoing discussions for partnering CUE-501 to extend capital runway.
• Financial: Extended cash runway to mid-2025, reduced cash burn from ~$40M to ~$30M per year, with partnerships expected to enhance cash position.

No specific financial performance data for product segments provided in the transcript.

• Capital market uncertainties affecting program advancement.
• Clinical trial delays/failures due to data maturation or regulatory hurdles.
• Competition from potential rival products impacting market positioning.

Q: Speak to trafficking capacity of CUE-501 and CMV positivity in general population A: CMV positivity ~65-70%, Immuno-STAT’s can penetrate tissue and engage relevant T cells, with trafficking studied via ImmunoPET imaging.

Q: Thoughts on current landscape and neoadjuvant study for CUE-101 A: CUE-101 combo shows better survival metrics than pembro mono; neoadjuvant study at Washington University progressing, close to enrollment completion.

Q: Funding and bridging gap with Ono opt-in A: Prudent business model, Ono partnership supportive, milestones and opt-in aligned, with partnerships to subsidize development.

Q: Next non-clinical data for 401 and 501 A: Continuing to generate data for 401 in collaboration with Ono, and in-vivo experiments for 501, to be released as datasets emerge.

Q: Safety differentiation from cell therapies for CUE-500 series A: Immuno-STAT’s in oncology show no clinically relevant immunogenicity, selective TCR engagement avoids broad T cell perturbation, and manufacturability as antibody-based biologics.