Kyntra Bio (KYNB) Fourth Quarter 2025 Earnings Conference Call Transcript

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Event Details

Date: Monday, March 16, 2026, at 5 p.m. ET

Participants

• Thane Wettig – Chief Executive Officer
• David DeLucia – Chief Financial Officer
• Carol Gaddum – Vice President of Product Development

Conference Call Overview

Present on the call were Thane Wettig (CEO), David DeLucia (CFO), and Carol Gaddum (VP of Product Development). After their prepared statements, the floor was opened for questions. Please note, today's discussion contains forward-looking statements regarding Kyntra Bio, Inc., which may cover topics such as partnerships with AstraZeneca and Astellas, financial projections, clinical trial progress, regulatory strategies, research and development, commercial outcomes, operational risks, and other business matters.

These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ significantly from those anticipated. For a comprehensive overview of these risks, refer to Kyntra Bio, Inc.'s filings with the SEC, including the latest Form 10-K and Form 10-Q. The company does not commit to updating forward-looking statements publicly. The press release with financial results and a webcast of this call are available in the Investors section of the company’s website.

With that, the call was handed over to CEO Thane Wettig.

CEO Remarks

Thane Wettig welcomed participants and provided an update on the progress of FG3246 and FG3180, a potential first-in-class antibody-drug conjugate (ADC) targeting CD46, along with its companion PET imaging agent for metastatic castration-resistant prostate cancer (mCRPC). He also discussed the development path for roxadustat as a treatment for anemia in lower-risk myelodysplastic syndromes (MDS). CFO David DeLucia then reviewed the financials, followed by a Q&A session. The CEO highlighted 2025 as a transformative year for the company.

Key Achievements in 2025

• Completed the sale of FibroGen China to AstraZeneca
• Repaid the senior secured term loan
• Extended cash runway through 2028
• Launched a Phase II trial for FG3246/FG3180 in mCRPC, with patient enrollment ongoing at multiple U.S. sites
• Reported top-line results from an investigator-sponsored trial of FG3246 combined with enzalutamide in mCRPC at ASCO GU
• On track to share interim results from the ongoing Phase II monotherapy trial in 2026

Advancements in Roxadustat

• Submitted the Phase III protocol for lower-risk MDS to the FDA
• Received Orphan Drug Designation for MDS
• Awaiting FDA feedback on the Phase III trial design, with plans to initiate the trial in the second half of the year
• Rebranded from FibroGen to Kyntra Bio, Inc. to reflect the company’s renewed focus on oncology and rare diseases

Strategic Positioning

Kyntra Bio, Inc. is confident that its mid- and late-stage pipeline, streamlined capital structure, and upcoming clinical milestones position the company to deliver new therapeutic options for patients and value for shareholders.

FG3246 and FG3180 Program Highlights

Late-stage prostate cancer remains an area of high unmet need, with approximately 290,000 new diagnoses annually in the U.S. and about 65,000 patients with metastatic, castration-resistant disease. The five-year survival rate for this group is just 30%, highlighting the urgent need for new therapies. FG3246 is seen as a potential new treatment, with a U.S. market opportunity estimated to exceed $5 billion per year.

CD46 as a Therapeutic Target

• CD46 is upregulated during tumor development and helps tumors evade immune destruction
• Its expression increases as prostate cancer progresses and after androgen signaling inhibitor treatment
• CD46 is highly expressed in mCRPC tissues, with less variability and higher median expression compared to PSMA, making it an attractive non-PSMA target

FG3246 and FG3180: Clinical Development

FG3246 is an ADC combining the YS5 antibody with an MMAE payload, targeting CD46 with minimal expression in normal tissues. This approach is independent of androgen receptor status, differentiating it from other prostate cancer therapies. FG3180, the companion PET imaging agent, uses the same targeting antibody and is in clinical development with its own IND. A biomarker for patient selection could enhance future Phase III trials and distinguish FG3246 in the treatment landscape.

FG3180 also presents a commercial opportunity as a companion diagnostic, similar to PSMA PET agents that generated nearly $2 billion in revenue in 2025.

Clinical Trial Results

• Phase Ib/II trial of FG3246 with enzalutamide in mCRPC showed promising antitumor activity, with a median radiographic progression-free survival (rPFS) of seven months in biomarker-unselected patients
• Patients who had progressed on one prior ARPI achieved a median rPFS of 10.1 months and a PSA50 response rate of 40%
• Higher tumor uptake of FG3180 correlated with PSA50 response, supporting its use as a PET imaging biomarker for patient selection
• Safety profile of the combination was consistent with prior studies, with reduced incidence of severe neutropenia due to G-CSF prophylaxis

Phase I Monotherapy Study

The Phase I monotherapy study of FG3246 demonstrated a median rPFS of 8.7 months in heavily pretreated, biomarker-unselected mCRPC patients, with 36% achieving a PSA reduction of over 50%.

Ongoing Phase II Monotherapy Trial

• Initiated in September, enrolling 75 patients in the post-ARPI, pre-chemo setting across three dose levels
• FG3180 will be used to further explore the correlation between CD46 expression and response to FG3246
• Interim analysis planned for 2026, with mature rPFS data expected in 2027
• Key design elements include higher dosing, G-CSF prophylaxis, and enrolling healthier patients earlier in their treatment journey

Future Outlook

The company is optimistic that these strategies will improve upon previous results and achieve a median rPFS of 10 months or more, which is considered commercially competitive. The FG3246 and FG3180 program is progressing, with interim Phase II results expected in 2026.

Roxadustat Program Update

There are roughly 49,000 patients in the U.S. with anemia due to lower-risk MDS. Current therapies provide transfusion independence for less than half of patients, and there are no oral treatments available or in late-stage development. Roxadustat offers the potential for a durable, orally administered therapy across multiple lines of treatment.

A post hoc analysis from the Phase III Matterhorn study showed that 36% of patients with high transfusion burden achieved transfusion independence for at least eight weeks with roxadustat, compared to 7% with placebo. These results are comparable to those seen with recently approved therapies for anemia in lower-risk MDS.

The target indication for roxadustat is patients with lower-risk MDS who are refractory to or ineligible for prior ESA treatment, with the potential to benefit both RS-positive and RS-negative patients. The company is awaiting FDA feedback on the Phase III protocol and is considering both internal development and strategic partnerships, with a goal to start the study in 2026. Roxadustat’s Orphan Drug Designation could provide at least seven years of regulatory exclusivity and a significant market opportunity.

Financial Summary

David DeLucia (CFO): For Q4 2025, total revenue was $1.3 million, down from $3.1 million in Q4 2024. For the full year 2025, revenue was $6.4 million, compared to $29.6 million in 2024. Operating costs and expenses for Q4 2025 were $14.8 million, up from $10.3 million in Q4 2024. For the full year, operating costs were $52.3 million, down from $180 million in 2024. R&D expenses for Q4 2025 were $7.3 million, and $23.5 million for the year, compared to $6.9 million and $95.7 million, respectively, in 2024. SG&A expenses for Q4 2025 were $7.3 million, and $27.7 million for the year, compared to $8.3 million and $49.3 million in 2024.

The net loss from continuing operations in Q4 2025 was $14.6 million ($3.61 per share), compared to $8.7 million ($2.15 per share) in Q4 2024. For the full year, the net loss was $58.2 million ($14.40 per share), compared to $153.1 million ($38.26 per share) in 2024. As of December 31, 2025, the company reported $109.4 million in cash, cash equivalents, investments, and accounts receivable, with a projected cash runway into 2028. The company has taken steps to reduce fixed costs and maximize investment in its U.S. pipeline.

Looking Ahead

Thane Wettig emphasized that Kyntra Bio is financially prepared to reach multiple clinical milestones through 2028, with a focus on advancing FG3246 and FG3180 and finalizing the Phase III protocol for roxadustat. The company is optimistic about the future and the opportunities ahead.

Q&A Highlights

Imaging and Commercial Potential of CD46

Questions were raised about the role of CD46 imaging compared to established PSMA agents and the commercial outlook. The company expects a similar regulatory pathway, where patients would need to test positive for CD46 via PET imaging before receiving FG3246. The commercial strategy may involve partnerships, and the company is following the model established by PSMA agents.

SUV as a Patient Selection Tool

There was discussion about using SUV (standardized uptake value) as a biomarker for patient selection. The Phase II trial aims to define CD46 positivity, potentially using SUV or other metrics, before moving to Phase III.

Patient Population in Trials

Clarification was provided that all patients in the Phase II monotherapy trial will have progressed on one prior ARPI, in contrast to the IST, where 40% had progressed on one and 60% on two or more ARPIs.

Roxadustat Regulatory Timeline

The company explained that the FDA was informed the Phase III trial would not start immediately, so feedback is expected within 60 to 90 days, rather than the standard 30 days for orphan drugs.

Closing Remarks

Thane Wettig thanked participants for joining the call and expressed appreciation for their interest in Kyntra Bio, Inc.

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