Kyntra Bio, Inc.

Thank you for standing by, and welcome to Kentra Bio's fourth quarter and full year 2025 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1-1 on your telephone. To remove yourself from the queue, you may press star 1-1 again. I would now like to hand the call over to Gaia Shamus, with LifeSci Advisors. Please go ahead.

Thank you, operator. Good afternoon, everyone. Thank you for joining today to discuss KintraBio's fourth quarter and full year 2025 financial and business results. I'm Gaia Chamis from LifeSci Advisors. Joining me on today's call are Zane Wettig, Chief Executive Officer, David Ilchia, Chief Financial Officer, and Carol Gedum, 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 Kintra 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 that statement. A more complete description of these and other material risks can be found in Kintra BIOS filing with the SEC, including our most recent Form 10-K and Form 10-Q. Kintra 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 Kintra Bio website at www.kintrabio.com. With that, I would like to turn the call over to the CEO, Zane Wedding. Zane?

Thank you, Gaia. Good afternoon, everyone, and welcome to our fourth quarter and full year 2025 earnings call. On today's call, I will provide an update on the continued progress with FG3246, a potential first-in-class antibody drug conjugate targeting CD46 and its companion PET imaging agent in metastatic castration-resistant prostate cancer, as well as the path forward for roxidustat as a potential treatment for anemia due to lower-risk modest plastic syndromes. Then David De La Chia, our CFO, will review the financials, after which we will open the call for your questions. On slide three, I'd like to start by highlighting the transformational year we had in 2025. We completed the sale of Hybrids in China to AstraZeneca, paid off our senior secure term loan, and extended our cash runway into 2028. This enabled us to start the phase two trial for FG3246 and FG3180 in the post-ARPI pre-chemo setting in metastatic castration-resistant prostate cancer, where we are actively enrolling patients at multiple sites in the U.S. We recently reported the top-line results presented at ASCO-GU from the investigator-sponsored trial of FG3246 in combination with enzalutamide in MCRPC, and we remain on track to report the interim results from our ongoing Phase II monotherapy trial of FG3246 and FG3180 in the second half of 2026. We also made important progress with Roxidustat with the submission of the Phase III protocol for lower risk modest plastic syndromes and the receipt of orphan drug designation for MDS. We expect feedback on the Phase III trial design from the FDA in the coming weeks with the aim of initiating the Phase III trial in the second half of this year. We began 2026 rejuvenated, rebranding FibroGent to Kentra Bio to better reflect the momentum and energy of a company focused on oncology and rare disease. We remain confident that with our mid and late stage assets, simplified capital structure, and upcoming catalysts across both clinical programs, we are well positioned to create meaningful therapeutic options for patients and significant value for shareholders. Moving to our FG3246 and FG3180 program in MCRPC. Slide five summarizes the high unmet need in late stage prostate cancer. Approximately 290,000 men are diagnosed with prostate cancer each year in the U.S. with about 65,000 drug treatable patients with metastatic disease that has become castration resistant. This group of patients has a grim five year survival rate of approximately 30%, underscoring the significant opportunity for new life extending treatments. We believe FG3246 could be this new treatment option and estimate the total addressable market to be well over $5 billion annually in the US alone. Slide six depicts the novelty of CD46, a tumor-selective target that has several distinguishing features. First, CD46 is upregulated during tumorigenesis and helps tumors evade complement-dependent cytotoxicity. Second, its expression is also upregulated in the progression from localized castration-sensitive prostate cancer to metastatic castration-resistant prostate cancer, and further overexpressed following treatment with androgen signaling inhibitors. Notably, CD46 is highly expressed in MCRPC tissues with lower interpatient variability and higher median expression compared with PSMA, making it an attractive non-PSMA therapeutic target. Turning to slide seven, FG3246 is our potential first-in-class ADC in development for MCRPC. The ADC combines the YS5 antibody with an MMAE payload to specifically target the tumor-selective epitope of CD46, whose expression is limited in normal tissue. FG3246 represents an androgen receptor agnostic approach, clinically differentiating it from other prostate cancer treatments currently in development, many of which target PSMA. The companion PET imaging agent, FG3180, utilizes the same YS5 targeting antibody as FG3246 and is also under clinical development with its own IND. We believe that having a patient selection biomarker would not only allow us to better enrich the patient population in a future phase three trial, it could also enable differentiation of FG3246 in the prostate cancer treatment paradigm. In addition, FG3180 could represent an important commercial opportunity as a companion diagnostic to FG3246, similar to the existing PSMA PET agents, which generated revenue of almost $2 billion in 2025. Slide 8 highlights the design of the investigator-initiated Phase 1B-2 trial of FG3246 in combination with enzalutamide and MCRPC, for which top line results were presented at the recent ASCO-GU meeting. These results, shown on slide nine, 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 one prior ARPI, the combination of FG3246 and enzalutamide achieved a median RPFS of 10.1 months. and demonstrated a PSA50 response of 40%. Notably, on slide 10, higher tumor uptake of FG3180 was associated with PSA50 response, underscoring the potential for FG3180 as a PET imaging biomarker for patient selection. On the right-hand part of the slide is an example of a PET image from the IST captured after treatment with FG3180 highlighting significant CD46-expressing tumors. The table on the left shows the correlation between tumor uptake of FG3180 and PSA50 response. 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 to greater response to FG3246 as measured by PSA50 versus those with a lower SUV, with a nominal p-value that just missed being statistically significant. This data demonstrates for the first time an association between CD46 expression and response to FG3246. Further evaluation of FG3180 is an important part of the ongoing Phase II monotherapy trial. Finally, on slide 11, the combination of FG3246 and enzalutamide had a similar safety profile to what was observed in the FG3246 phase 1 monotherapy trial. Importantly, the incidence of grade 3 or greater neutropenia was substantially reduced with the utilization of GCSF prophylaxis when compared to the phase 1 monotherapy trial. This approach is an important design element of our ongoing phase 2 monotherapy trial. In summary, the results of the IST provide us with the key insights that further validate design elements in our ongoing phase 2 monotherapy trial. which we believe has the potential to improve upon the median RPFS observed in the Phase I monotherapy trial, which I will cover in greater detail next. Briefly on slide 12, we recap the top-line results from the Phase I monotherapy study of FG3246, which we believe are competitive when compared to other approved and investigational treatments. These results demonstrated a median RPFS of 8.7 months in patients with MCRPC that were heavily pretreated and were not biomarker selected. PSA reductions of greater than 50% in this population were achieved in 36% of these patients. Moving to slide 13, based on the phase one monotherapy results, we initiated the FG3246 phase two monotherapy dose optimization trial in September. We plan to enroll 75 patients in the post-ARPI pre-chemo setting across three dose levels to determine the optimal dose for Phase 3 based on efficacy, safety, and PK parameters. It is important to note that FG31AD will be an integral part of the study as we seek to further explore what was demonstrated in the Phase 1B-2 combination trial and determine whether there is further correlation between CD46 expression and response to the ADC in this all-comers Phase 2 trial. An interim analysis of the open-label Phase 2 trial is planned for the second half of and will include PSA50, ORR, safety, PK, and exposure response data. Importantly, we expect mature RPFS data to become available in 2027 as patients continue on their treatment with FG3246 and the trial progresses toward completion. On slide 14, I'd like to highlight three important steps we have taken with the design of the ongoing phase two monotherapy trial which were further validated with the IST results as we aim to improve upon the 8.7 months of median RPFS demonstrated in the Phase I monotherapy trial. First, leveraging earlier evidence of an exposure-response relationship, the Phase II study is using three of the highest doses from the Phase I dose escalation and expansion study. Second, primary prophylaxis with GCSF is utilized to mitigate neutropenia, which was successfully demonstrated in the phase two portion of the recently disclosed IST. The mitigation of neutropenia could enable more consistent exposure to the ADC with fewer dose interruptions or adjustments early in the course of treatment, which could extend the duration of therapy and potentially enhance the efficacy of the ADC. Third, we are enrolling healthier patients in earlier lines of therapy versus the median five prior lines of therapy in the phase one trial, The 10.1 months of median RPFS demonstrated in the IST in patients who progressed on only one prior ARPI underscores the potential of FG3246 in this patient population. Together with the insights from the IST results, we believe that these design elements have the potential to improve upon the Phase I results and achieve a median RPFS of 10 months or greater, which we believe is the benchmark for commercial competitiveness. Slide 15 highlights the recent and upcoming catalysts for the FG3246 and FG3180 program. We are actively enrolling patients and are on track to report the interim results from the Phase II monotherapy trial in the second half of this year. To summarize, on slide 16, FG3246 targets a novel epitope on prostate cancer cells with first-in-class potential, given there are no other CD46-targeted projects in clinical development and no non-PSMA approaches in mid- to late-stage development with a companion PET imaging approach. Targeting CD46 with FGD3246 has already demonstrated promising early efficacy signals with an acceptable safety profile, both in monotherapy and combination settings. We have a well-designed Phase II monotherapy trial in the post-ARPI pre-chemo setting in MCRPC to further to attempt to further build upon the 8.7 months of median RPFS demonstrated in the Phase 1 trial. We are looking forward to the interim readout later this year, and we'll update you as the program progresses. Turning now to Roxidustat. Slide 18 highlights the unmet need and the potential for Roxidustat in the approximately 49,000 patients with anemia associated with lower-risk MDS in the U.S. alone. Current treatments, as measured by transfusion independence, are effective in less than 50% of patients. With no oral options currently on the market or in late stage development, a significant opportunity exists to offer a potential new treatment that is durable with convenient oral administration to patients across multiple lines of therapy. Moving to slide 19, I would like to quickly highlight the data from a post hoc analysis in a subgroup of patients with anemia of lower risk MDS who entered the Phase III Matterhorn study of roxidustat with a high transfusion burden. In this analysis, using the international working group definition for high transfusion burden of four or more RBC units in two consecutive eight-week periods, roxidustat showed a meaningful treatment effect with 36% of patients achieving transfusion independence for at least eight weeks versus only 7% in the placebo group with a nominal p-value of 0.041. These results are highly similar to the pivotal trial results for the two most recently approved therapies for anemia associated with lower risk MDS. Based on these results, as we turn to slide 20, our target indication for Roxidustat is in patients with lower risk MDS who are refractory to or ineligible for prior ESA treatment, where we believe Roxidustat has the potential to elevate the standard of care across multiple treatment lines. In addition, We believe we have an opportunity to demonstrate efficacy across both RS-positive and RS-negative patients. When looking at the prevalence of the disease, RS-negative patients make up more than 50% of patients in lower-risk MDS. There is a great opportunity to potentially move up-line and help these patients, given that luspatercept is not approved in the second-line setting in RS-negative patients. Moving to slide 21, after aligning with the FDA last summer on key design elements, of a Phase III trial, we submitted the final protocol to the FDA and expect to receive their feedback in the coming weeks. We are currently exploring the opportunity to develop Roxidustat internally or with a strategic partner and aim to initiate this study in the second half of 2026. To summarize on slide 22, there is significant opportunity for Roxidustat in anemia associated with lower-risk MDS with no other oral treatments currently available or in late-stage With Roxadustat being granted orphan drug designation, we believe that a minimum of seven years of regulatory exclusivity, combined with an attractive market opportunity and efficient commercial model, represents a substantial economic opportunity for Roxadustat in anemia associated with lower-risk MDS. With that, I will now turn the call over to Dave to discuss the company's financials. Dave? Thank you, Thayne.

For the fourth quarter of 2025, total revenue was $1.3 million compared to $3.1 million for the same period in 2024. For a full year 2025, total revenue was $6.4 million compared to $29.6 million for the full year 2024. Now moving down the income statement. 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&D expenses for the fourth quarter of 2025 were $7.3 million compared to $6.9 million in the fourth quarter of 2024. And R&D expenses for full year 2025 were $23.5 million compared to $95.7 million in full year 2024. SG&A expenses for the fourth quarter of 2025 were $7.3 million compared to $8.3 million in the fourth quarter of 2024. SG&A expenses for full year 2025 were $27.7 million compared to $49.3 million in full year 2024. During the fourth quarter of 2025, we recorded a net loss from continuing operations of $14.6 million or $3.61 net loss per basic and diluted share as compared to a net loss of $8.7 million or $2.15 per basic and diluted share for the fourth quarter of 2024. During full year 2025, we recorded a net loss from continuing operations of $58.2 million or $14.40 net loss per basic and diluted share, as compared to a net loss of $153.1 million, or $38.26 per basic and diluted share for the full year of 2024. Now shifting towards cash. As of December 31st, we reported $109.4 million in cash, cash equivalents, investments, and accounts receivable. We expect the company to have cash runway into 2028. In summary, 2025 was a transformational year for the company, and we have taken important steps to reduce our fixed-cost infrastructure to maximize our cash runway and enable investment in our U.S. pipeline opportunities. Thank you, and I will now turn the call back over to Thayne.

Thank you, Dave. We are well-capitalized to support multiple clinical milestones into 2028 and remain laser-focused on advancing FG3246 and its companion, FG3180 program with expected interim analysis from the Phase II monotherapy trial in the second half of 2026. We look forward to finalizing the Phase III protocol for Roxaducet MDS and are targeting initiation of the trial in the second half of 2026. In summary, 2025 was a transformational year for us on multiple fronts, and we are excited for the opportunities ahead. I would now like to turn the call over to the operator for Q&A.

Thank you. As a reminder, to ask a question, you will need to press star 1-1 on your telephone. To remove yourself from the queue, you may press star 1-1 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Andy Shea of William Blair. Your line is open, Andy.

Thanks for taking our questions. Two for us, if you don't mind. One has to do with maybe the imaging of CD46 opportunity. Maybe if you can kind of paint a picture for us just in the context of having PSMA imaging agents on the market now for three plus years now, where would you think that this would fit in and also the corresponding maybe commercial opportunity? So that's question number one. Question number two, for the SUV data, obviously very provocative having a correlation there. So if you think about it as a patient selection opportunity, can you help us think about some of this KOL feedback that kind of talks about SUV potentially as a as a way to enrich patients who will most likely benefit. But on the other hand, there are also KOLs going to talk about low SUV patients who also can benefit. So maybe help us understand those kind of two arguments in the field. Thank you so much.

Yeah, thanks, Andy. Appreciate the question. I'll go ahead and kick it off, and then I'm going to ask Carol to add to it. So first, related to you know, imaging and CD46 and how that, you know, would compare and contrast to PSMA agents, you know, which have been on the market to your point for, you know, three plus years. And by the time we would make it to market, obviously several years beyond that and also around the commercial opportunity. And then kind of potential sequencing, which I think was maybe part of your question. So clearly, you know, if we were able to make it to market, you know, Pulpicto in this, post-ARPI, pre-chemo setting, we would anticipate being pretty well entrenched there. And as I'm sure you know, Andy, because you cover the space, in order for a patient to be prescribed Plobicto, they have to undergo a treatment with a PSMA PET imaging agent, undergo a PET scan, and be positive, show positive uptake of PSMA PET. we would anticipate the same thing for our PSMA or our CD46 PET agent. And so, you know, the great thing is, is that PluVicto and the products from Lantheus and Telex have pretty much created the playbook and we're trying to run that exact same playbook. And so we would anticipate that if FG3246 makes it to market, that the FDA would label FG3246 fairly similarly to how Plovicta was labeled, that patients must undergo treatment with a CD46 PET imaging agent and be positive for CD46. And so we would think it would be in a similar sort of way. As it relates to the commercial opportunity, you know, clearly we don't have the kind of expertise in this space that companies like Telex and Lantheus have. So as we further characterize the CD46 Plovicta, PET agent through the course of the Phase II trial, we'll be further evaluating what role Kentra Bio should play versus what role could perhaps strategic partners play in the further development. But we think we're pretty well set as it relates to the Phase II portion of the program. Carol, let me turn it over to you, and you can add to that.

Yes. Thank you for the question, Andy. We're very clear of the fact that we'll be in a world where there are multiple PET agents available for these patients and our clinical development strategy for this companion diagnostic needs to be designed in a way to address the question around sequencing and when to use and when it's justified. We believe that with the differentiation that our ADC offers in patients with CD46-positive that that would justify a PET scan and hence would provide this displacement in the treatment algorithm. But it's something that we're keenly aware of and raises the bar for development strategies in this space, given the coexistence. Thanks, Carol. I want to talk on your second question, or can you, Zain?

Yeah, go ahead.

Okay, your second question around SUV, and a really good one. The phase two is designed for us to understand how we define CD46 positivity. And that might be based on SUV, but might also be based on something else, as we know, as you mentioned, that the field is also keen at looking at metrics outside of SUV. So maybe a bit early to comment on that. We look at that as part of the phase two. That's the clear definition. benchmark that we need to hit before we can take this into a phase three to define positivity and the right metric.

Let me maybe just add a couple more comments. First, Andy, going back to that first question, let's say that a patient is prescribed Pluvicto, the DRLT, after showing positivity for PSMA PET, and they ultimately progress on Pluvicto. We would then, you know, with a non-PSMA approach, you know, focused on CD46, we would then think it's highly possible for a patient to then be treated with with PEP46, undergo a scan, and if they showed positivity for CD46, then be prescribed FG3246. So that's how we also tend to think about it from a sequencing perspective.

That's super helpful. Look forward to the second half update. Thank you.

Great. Thanks, Andy.

Thank you. Our next question comes from the line of Matthew Keller of HCW. Please go ahead, Matthew.

Hey, good afternoon, and thanks for taking the questions, too, from me as well, if that's okay. The first one, 3246 program, and this is a bit of a point of clarification, but based on these really positive ARPI results, based on, you know, more efficacy seen at an earlier stage of treatment, I was wondering, and I just want to be clear, are we expecting the balance of patients between the IST and the monotherapy study to be about the same? Or do you think there might be a difference, I guess, with recruitment or, I guess, the line of treatment you guys are thinking of recruiting? And then my second question on the ROXA program, I wonder if you have any updates, I guess, on the maturity level of, you know, potential partnering or BD efforts there. Thanks.

Yeah, thanks, Matt, for the questions. I'll take the first one and then ask Carol to add anything else that might be relevant, and then I'll handle the ROXA Digitech question as well. First, in terms of of kind of the ARPI efficacy, the balance of patients from the recently disclosed IST versus the ongoing Phase II monotherapy. There were about 60% of patients from the IST that had progressed on two or more ARPIs, about 40% of patients who had progressed on only one ARPI. In our Phase II monotherapy, patients will have only progressed on one prior ARPI and be in the pre-chemo setting. And so that's, I think, a pretty important differentiator. So 100% of our patients in the Phase II monotherapy trial will have progressed on one prior ERPI, whereas in the IST, about 40% of patients had progressed on only one, and then 60% had progressed on two or more. Carol, anything to add to that?

The only thing to add on here is that the setting that we're looking at is really that established by PSMA-4. So it's looking for efficacy benchmarks that's really what we're targeting. So, it's post one prior ARSI.

And then, Matt, as it relates to the Racha Doucette question, we're not going to comment on the specifics of where we are with respect to that effort, you know, where we say we're evaluating the opportunity to develop it internally versus potentially having some sort of a collaboration with a strategic. We're continuing to to explore both paths, but we're not at a place right now where we can comment further on that.

Yep. No, it makes sense. Thanks again, guys.

Great.

Thank you, Matt. Appreciate the continued coverage.

Thank you. Our next question comes from the line of Chen Lin of Lin Asset Management. Your line is open, Chen.

All right, thank you for taking my questions. Actually, most of my questions have already been answered. I'm just curious about Rocto. You know, the FDA is supposed to give feedback in 30 days, giving its often status. Why there seems to be a delay of the, you know, acceptance of the IND?

Yeah, thanks, Chen. When we submitted the protocol to the FDA right before Christmas, we let the FDA know that we were not going to be imminently starting the phase three trial. And so what typically happens is when a company is fully geared up to start the phase three and they submit the final protocol, the FDA typically gets back within 30 days. The FDA knew that they had a little bit more time. And so what they had signaled to us was 60 to 90 days. And we're right in that 60 to 90 day period right now. And so when we say that we expect feedback in the coming weeks that's based upon the guidance that had been provided from the FDA when we had submitted the protocol right before the holidays.

Okay, great. Thank you.

Good luck. No, thanks, Jen. Appreciate the support.

Thank you. I would now like to turn the conference back to Thayne Whedon for closing remarks. Sir?

Yeah.

No, thank you.

And thank you for joining us for today's fourth quarter and full year earnings call. And we appreciate your interest in Kendra Bio. Enjoy the rest of your day. Thanks, everybody.

This concludes today's conference call. Thank you for participating. You may now disconnect.