Kyntra Bio, Inc. Q1 FY2026 earnings call

FG3246/FG3180 (MCRPC Program)

• FG3246 is a potential first-in-class CD46-targeted antibody drug conjugate (ADC) for metastatic castration-resistant prostate cancer (MCRPC), paired with FG3180, a companion PET imaging agent for CD46 expression. CD46 is a compelling non-PSMA target: it is highly and homogeneously expressed in 50-70% of MCRPC tumors, with limited expression in normal tissue, and upregulated during disease progression.
• Phase 1 monotherapy data in heavily pretreated, unselected patients showed encouraging efficacy: median radiographic progression-free survival (RPFS) of 8.7 months, 36% of patients achieved PSA reductions >50%, and 20% of evaluable patients achieved an objective response rate (ORR) with a 7.5-month median duration of response. A UCSF-led phase 1B2 investigator-sponsored trial (IST) of FG3246 plus enzalutamide showed a median RPFS of 10.1 months and 40% PSA50 response in patients who had progressed on only one prior ARPI therapy.
• The IST also confirmed that primary GCSF prophylaxis significantly reduces grade 3+ neutropenia, a key safety finding incorporated into the ongoing Phase II trial design. The trial additionally provided the first evidence of an association between higher FG3180 tumor uptake (indicating higher CD46 expression) and greater PSA50 response to FG3246.
• The ongoing Phase II monotherapy dose-optimization trial is enrolling 75 post-1ARPI pre-chemo MCRPC patients across 21 activated U.S. sites. Design improvements over Phase I include testing three higher doses from the Phase I trial, mandatory GCSF prophylaxis to reduce dose interruptions, and enrollment of earlier-line therapy patients. An interim analysis is planned for Q4 2026, with mature RPFS data expected in 2027. The trial targets a median RPFS of 10+ months, the benchmark for commercial competitiveness.

Roxidustat (Lower-Risk MDS Anemia Program)

• Roxidustat is an oral investigational treatment for anemia associated with lower-risk myelodysplastic syndromes (MDS), which received orphan drug designation at the end of 2025. There are no approved oral treatments for this indication, and existing therapies achieve transfusion independence in less than 50% of patients, creating significant unmet need.
• A post-hoc subgroup analysis of the Phase II Matterhorn study in patients with high transfusion burden showed 36% of roxidustat-treated patients achieved at least 8 weeks of transfusion independence, compared to only 7% of placebo-treated patients (p=0.041), results comparable to recently approved therapies for this indication.
• The company received constructive feedback from the FDA on Phase III trial design in April 2026, and is in the final stages of protocol finalization. The Phase III trial will have a primary endpoint of 8-week transfusion independence, with key secondary endpoints of 12- and 16-week transfusion independence. Roxidustat has potential to deliver efficacy in both RS-positive and RS-negative lower-risk MDS, a key advantage over existing leading therapies that lack differentiated efficacy in RS-negative patients.

Kintra Bio is a clinical-stage biotech with two core product programs and no marketed product segments as of Q1 2026. Aggregate total revenue for Q1 2026 was $3.7 million, a $1.0 million increase from $2.7 million in Q1 2025. Total operating expenses for Q1 2026 were $17.6 million, a slight decrease from $17.7 million in Q1 2025. Research and development (R&D) expenses were $7.6 million in Q1 2026, down from $9.2 million in Q1 2025. Selling, general and administrative (SG&A) expenses were $5.9 million in Q1 2026, down from $8.1 million in Q1 2025. Net loss from continuing operations was $15.1 million ($3.74 per basic/diluted share) in Q1 2026, compared to a net loss of $16.8 million ($4.15 per basic/diluted share) in Q1 2025. As of March 31, 2026, the company held $100.3 million in total cash, cash equivalents, investments, and accounts receivable.

• The company reaffirmed that its existing cash position of $100.3 million as of March 31, 2026 provides a cash runway into 2028, sufficient to fund all planned pipeline milestones through that timeframe.
• The interim analysis for the FG3246/FG3180 Phase II monotherapy trial remains on track to be completed in Q4 2026, with mature RPFS data expected in 2027, unchanged from prior guidance.
• Initiation of the Roxidustat Phase III trial for lower-risk MDS anemia remains planned for the second half of 2026, consistent with prior guidance. No changes to existing clinical or financial guidance were announced during the call.

• All forward-looking statements regarding clinical trial initiation, enrollment, interim and final results, regulatory outcomes, and commercial opportunity are subject to inherent risks and uncertainties that could cause actual results to differ materially from projections. These risks are detailed in the company's SEC filings, including its most recent Form 10-K and Form 10-Q.
• Clinical development risks include the possibility that interim Phase II data will not meet the company's pre-specified efficacy or safety hurdles, that the observed correlation between CD46 expression and FG3246 response will not be statistically confirmed in the larger Phase II trial, or that the Phase III trial will fail to replicate the efficacy signals seen in earlier-phase studies.
• The company has not yet finalized a path for Roxidustat development, which could be done independently or via a strategic partnership, introducing uncertainty around trial resourcing and timing.
• The company does not undertake any obligation to update forward-looking statements after the call to reflect new information or future events.

Q: What metrics will management look for in the Q4 2026 Phase II interim analysis to approve using FG3180 for patient selection in Phase III, and what role will FG3180 play if the correlation is not statistically confirmed? / A: Management will look for statistically significant confirmation of the correlation between FG3180-measured CD46 expression and FG3246 response, alongside standard efficacy metrics including PSA50 response, ORR, dose response, and PK parameters. If a strong correlation is confirmed, FG3180 will be used to enroll only CD46-high patients in Phase III. If no correlation is confirmed, FG3180 will still be used to collect CD46 expression data in an all-comer Phase III population to further characterize the target.

Q: Have there been any new expressions of interest or updated feedback for FG3180 following the release of the IST data? / A: Management declined to comment on ongoing business development discussions. They noted that the association between CD46 expression and FG3246 response and the GCSF neutropenia mitigation finding from the IST are both intriguing to external parties, and that strong investigator enthusiasm for the program is reflected in active enrollment at the 21 activated trial sites.

Q: When can additional details on the Roxidustat Phase III trial be expected? / A: The FDA's feedback on trial design was highly constructive on both clinical and statistical fronts, the CRO for the trial has been selected, and the protocol is in the final stages of completion. Management will update the investment community as progress continues, but does not plan to release further protocol details at this time. A decision on whether to develop the asset independently or with a strategic partner is still pending.