Kyntra Bio, Inc. Q4 FY2025 earnings call

CEO Zane Wettig provided update on FG3246 and roxidustat progress. Completed sale of Hybrids in China to AstraZeneca, paid off senior secure term loan, extended cash runway to 2028. Started phase two trial for FG3246 and FG3180 in metastatic castration-resistant prostate cancer. Reported top - line results from investigator - sponsored trial of FG3246 in combination with enzalutamide. Made progress with Roxidustat, submitted Phase III protocol for lower risk myelodysplastic syndromes, received orphan drug designation for MDS. Began 2026 by rebranding FibroGent to Kentra Bio. FG3246 is a potential first - in - class ADC targeting CD46, has a companion PET imaging agent FG3180. CD46 is a tumor - selective target with certain distinguishing features. FG3246 combines YS5 antibody with MMAE payload. Results from investigator - initiated Phase 1B - 2 trial of FG3246 in combination with enzalutamide showed encouraging anti - tumor activity. FG3180's tumor uptake was associated with PSA50 response. FG3246 phase two monotherapy dose optimization trial was initiated in September, enrolling 75 patients. Roxidustat has unmet need in anemia associated with lower - risk MDS, post hoc analysis showed meaningful treatment effect. Submitted final protocol for Roxidustat's Phase III trial, expect FDA feedback in coming weeks, aim to initiate trial in second half of 2026

For the fourth quarter of 2025, total revenue was $1.3 million compared to $3.1 million for the same period in 2024. For full year 2025, total revenue was $6.4 million compared to $29.6 million for full year 2024. Total operating costs and expenses for the fourth quarter of 2025 were $14.8 million compared to $10.3 million for the fourth quarter of 2024. Total operating expense costs and expenses for full year 2025 were $52.3 million compared to $180 million for full year 2024. R\u0026D expenses for the fourth quarter of 2025 were $7.3 million compared to $6.9 million in the fourth quarter of 2024. R\u0026D expenses for full year 2025 were $23.5 million compared to $95.7 million in full year 2024. SG\u0026A expenses for the fourth quarter of 2025 were $7.3 million compared to $8.3 million in the fourth quarter of 2024. SG\u0026A expenses for full year 2025 were $27.7 million compared to $49.3 million in full year 2024. During the fourth quarter of 2025, net loss from continuing operations was $14.6 million or $3.61 net loss per basic and diluted share. During full year 2025, net loss from continuing operations was $58.2 million or $14.40 net loss per basic and diluted share. As of December 31st, cash, cash equivalents, investments, and accounts receivable were $109.4 million and cash runway into 2028 was expected

Expect to report interim results from the Phase II monotherapy trial of FG3246 in the second half of 2026. Expect feedback on the Phase III trial design for Roxidustat from the FDA in the coming weeks and aim to initiate the Phase III trial in the second half of 2026

Remarks include forward - looking statements subject to risks and uncertainties that could cause actual results and events to differ materially from those projected. A more complete description of risks can be found in Kintra BIOS filing with the SEC, including most recent Form 10 - K and Form 10 - Q. Kintra Bio does not undertake to update publicly forward - looking statements

Q: Andy Shea asked about the CD46 imaging opportunity and SUV data.

A: Zane Wettig and Carol Gedum responded, discussing how CD46 PET agent would fit in similar to PSMA agents, commercial opportunity considerations, and that SUV is part of phase II evaluation.

Q: Matthew Keller asked about FG3246 program patient balance and ROXA program partnering.

A: Zane Wettig responded, talking about patient line of treatment difference in IST and monotherapy study, and that ROXA partnering is under exploration.

Q: Chen Lin asked about Roxidustat FDA feedback delay.

A: Zane Wettig responded, explaining that FDA knew they had more time and expected feedback in 60 - 90 days as they submitted protocol before Christmas