GenFleet Therapeutics (Shanghai) (2595) Investor Day presentation summary

GFH375 in pancreatic cancer

• KRAS mutations occur in ~80–90% of pancreatic cancers; G12D accounts for 43.6% of KRAS-mutated cases and is associated with poorer survival outcomes.

• ESMO 2025 data: ORR 41% (24/59; 90% CI 30–52%), disease control rate 97%, with nearly 70% of participants treated in third line or later.

• At median follow-up of 5.65 months, median PFS was 5.52 months and 4-month PFS was 78.2% in 66 participants.

• Reported safety was manageable; common treatment-related events were mainly grade 1–2 gastrointestinal and hematologic toxicities. Grade 3 or higher TRAEs were 31.8% in the 2L+ cohort.

• A pivotal Phase III trial is underway in 2L+ metastatic PDAC, randomizing GFH375 600 mg QD against investigator-choice chemotherapy; primary endpoints are PFS and OS, with crossover allowed.

GFH375 in NSCLC

• In previously treated KRAS G12D-mutated NSCLC, ORR was 57.7% among 26 evaluable patients and 68.8% among 16 patients receiving 600 mg QD; DCRs were 88.5% and 93.8%, respectively.

• The study included 28 patients; 96.4% had received prior immunotherapy and all had received platinum-based chemotherapy. Median follow-up was 21.8 weeks.

• Median PFS was not reached; the 4-month PFS rate was above 75%. At 600 mg QD, median follow-up was 4.2 months.

• No new safety signals were reported; frequent TRAEs were mainly grade 1–2 gastrointestinal and hematologic events. Grade 3–4 neutropenia occurred in 6.3% and anemia in 4.2%.

• Development plans include a single-arm pivotal study for 2L+ NSCLC and a confirmatory study; monotherapy and combination regimens are also planned for earlier-line settings.

GFS202A for cachexia

• Tumor cachexia prevalence was reported at 37.0% overall and 62.8% in pancreatic cancer; cachexia is associated with weight and muscle loss, inflammation and reduced appetite.

• GFS202A is a GDF15/IL-6 bispecific antibody designed to block two cachexia-related pathways; the presentation positions it as a first-in-class dual-target approach.

• In the first four dose cohorts, no DLTs, treatment-related serious adverse events or grade 3+ treatment-related events were reported. Exposure rose with dose, and weight gain and appetite improvement were observed across multiple cohorts.

• GDF15 fell rapidly to the assay’s detection limit and remained suppressed after dosing; CRP levels also decreased.

• A Phase I dose-escalation study is ongoing; planned development includes cachexia trials and exploration with PD-1/PD-L1 therapies for resistance and immunomodulation.