Kyntra Bio, Inc. Common Stock 2026 Q2 Earnings Call

Please go ahead. Thank you, Latonia, and good afternoon, everyone.

Thank you for joining today to discuss Kyntra Bio's second quarter 2026 financial and business results. I'm Gaia Shamis from LifeSci Advisors. Joining me on today's call are Thane Wettig, Chief Executive Officer, David DeLucia, Chief Financial Officer, and Carol Gaddum, Vice President of Product Development. Following the prepared remarks, we will open the call to your questions. I would like to remind you that remarks made on today's call include forward-looking statements about Kyntra Bio. Such statements may include, but are not limited to, collaborations with AstraZeneca and Astellas, financial guidance, the initiation, enrollment, design, conduct, and results of clinical trials, regulatory strategies and potential regulatory results, research and development activities, commercial results and results of operations, risks related to our business, and certain other business matters.

Each forward-looking statement is subject to risks and uncertainties that could cause actual results and events to differ materially from those projected in the statement. A more complete description of these and other material risks can be found in Kyntra Bio's filing with the SEC, including our most recent Form 10-K and Form 10-Q. Kyntra Bio does not undertake any obligation to update publicly any forward-looking statements, whether as a result of new information, future events, or otherwise. The press release reporting the company's financial results and business updates, and a webcast of today's conference call can be found on the investor section of Kyntra Bio website at www.kyntrabio.com. With that, I would like to turn the call over to the CEO, Thane Wettig.

Thane? Thank you, Gaia. Good afternoon, everyone, and welcome to our second quarter 2026 earnings call.

On today's call, I will provide an update on the important progress we have made across our clinical portfolio. First, with FG-3246, our potential first-in-class antibody drug conjugate targeting CD46 and its companion PET imaging agent in metastatic castration-resistant prostate cancer. Second, with roxadustat, our potential treatment for anemia due to lower risk myelodysplastic syndromes. Then David DeLucia, our CFO, will review the financials, after which we will open the call for your questions. Starting with slide 3, I'd like to highlight our mid and late-stage programs and upcoming catalysts.

The phase II monotherapy trial for FG-3246 and its companion diagnostic FG-3180 in the post-ARPI pre-chemo setting in metastatic castration-resistant prostate cancer continues to actively enroll patients, and we are on track for the results from the interim analysis in the fourth quarter of this year. With our roxadustat program, the protocol for the phase III trial has been finalized, and we are advancing towards our goal of initiating the registrational trial in the fourth quarter of 2026. With a simplified capital structure and cash runway into 2028, we remain committed to executing on our strategic vision and look forward to the upcoming catalysts for both clinical programs. Let's start with the FG-3246 and FG-3180 program in mCRPC. The unmet need for new treatments for the 65,000 men in the U.S. diagnosed every year with drug-treatable castration-resistant metastatic disease is substantial.

Targeting CD46, a novel tumor-selected multifunctional epitope that helps tumors evade complement-dependent cytotoxicity could help address this need. Moving to slide five. What sets CD46 apart from non-PSMA tumor antigen targets for metastatic prostate cancer centers on four key points. First, it is highly expressed in prostate cancer and other tumors, yet with limited expression in normal tissue. Second, CD46 is upregulated during tumorigenesis as well as during the progression from localized castration-sensitive prostate cancer to metastatic castration-resistant prostate cancer. Third, an estimate 50%-70% of patients have high CD46-expressing tumors. Finally, relative to PSMA, CD46 expression is more uniform with lower interpatient variability and with higher median expression in mCRPC tissues, which make it a compelling non-PSMA therapeutic target. Slide six highlights FG-3246, our CD46 targeting potential first-in-class ADC, which combines the YS5 antibody with an MMAE payload.

MMAE is the payload for five currently marketed ADCs that generated approximately $5 billion in worldwide revenue in 2025, making it a well-characterized therapeutic approach for treating solid tumors. The YS5 antibody offers an androgen receptor-agnostic and non-PSMA approach, differentiating it from many of the prostate cancer treatments currently in development. As with the ADC, our companion imaging agent, FG-3180, utilizes the same YS5 targeting antibody and is being developed under its own IND. We believe that having a patient selection biomarker could enable us to potentially enrich the patient population in a phase III trial, while also differentiating FG-3246 in the prostate cancer treatment paradigm. It also represents an important commercial opportunity as a companion diagnostic to FG-3246 similar to the existing PSMA PET agents, which generated revenue of almost $2 billion in 2025.

FG-3180 is an important part of our ongoing Phase II trial, where we will assess the correlation between CD46 expression as measured by the PET agent and response to FG-3246. Our aim is a clinically differentiated therapeutic in a competitive yet highly unsatisfied mCRPC market. Importantly, we are the only non-PSMA program in mid to late-stage development that combines a therapeutic with a companion PET imaging agent. The excitement we have in this program comes from the clinical results for FG-3246 across two distinct trials. We believe these results, summarized on slide seven, are competitive when compared to other approved and investigational treatments. In the Phase I monotherapy trial highlighted on the left part of the slide, FG-3246 demonstrated a median rPFS of 8.7 months in patients with mCRPC who were heavily pre-treated and were not biomarker selected, with PSA50 response of 36%.

20% of the 25 RECIST evaluable patients achieved an ORR with a meaningful duration of response of 7.5 months. It is important to note that all of these ORRs were demonstrated at the 2.7 milligram per kilogram adjusted body weight dose utilized in the expansion phase of the trial, providing early evidence of a dose-response relationship. In the top line results from the Phase I-B/II investigator-initiated study at UCSF summarized on the right side, combination of FG-3246 with enzalutamide demonstrated encouraging anti-tumor activity with seven months of median radiographic progression-free survival in biomarker unselected patients across the entire cohort of 44 patients. Importantly, in patients who had progressed on only one prior ARPI, the combination of FG-3246 and enzalutamide achieved a meaningful median rPFS of 10.1 months with a PSA50 response of 40%.

In addition to the efficacy measures, the IST provided us with important insights into the adverse event profile of the ADC. The use of G-CSF prophylaxis led to a significant decrease in Grade 3 or greater neutropenia compared to the Phase I monotherapy trial. This approach is now designed into our ongoing Phase II monotherapy study, where our objective is to keep more patients on their initial dose without the same degree of dose interruption or reduction experienced in the Phase I monotherapy trial with the aim to build upon the 8.7 months of rPFS demonstrated in the Phase I trial. Moving to slide eight, an additional insight we gained from the IST is that higher tumor uptake of FG-3180 was associated with greater PSA50 response. The PET imaging on the right is from a patient with clear and meaningful expression of CD46 after exposure to FG-3180.

The bottom row of the table on the left shows that patients with a higher average maximum standardized uptake value or SUV of a target lesion when normalized to the SUV of the blood pool demonstrated a trend of greater PSA50 response to FG-3246 versus those with a lower SUV, with a nominal P value that just missed being statistically significant despite the small number of patients. This is the first observed association between CD46 expression and response to FG-3246. We aim to further characterize this association as part of the ongoing Phase II monotherapy trial. Slide nine lays out the design for this Phase II monotherapy trial, where we will enroll 75 patients in the post one ARPI pre-chemo setting across three dose levels with the primary objective to select the optimal Phase III dose based on efficacy, safety, and PK measures.

All patients in the study will be treated with FG-3180 in order to further explore the correlation between CD46 expression and response to the ADC in this biomarker unselected trial. The interim analysis of this open label trial is on track for the fourth quarter of this year and will include PSA50 response, ORR, safety, PK, and exposure response data. Futility will be assessed by a composite response rate of PSA50 and ORR. Importantly, we expect mature rPFS data to become available throughout 2027 as patients continue their treatment with FG-3246 and the trial progresses toward completion. On slide 10, we would like to emphasize the three design elements we have incorporated with the aim of improving upon the 8.7 months of median rPFS demonstrated in the Phase I trial.