Day, and thank you for standing by. Welcome to the Kyntra Bio First Quarter 2026 Earnings Conference Call. At this time, all participants are in listen only mode. After the speaker's presentation, we'll open up for questions. To ask a question during this session, you will need to press star one one on your telephone. You'll then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's call is being recorded. I would now like to hand it over to our first speaker, Gaia Shamis. Please go ahead.
Thank you, Victor. Good afternoon, everyone, and thank you for joining us today to discuss Kyntra Bio's first 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 that statement. A more complete description of these and other material risks can be found in Kyntra Bio filing with the SEC, including our most recent Form 10-K and Form 10-Q. Kyntra Bio does not undertake any obligations 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 update and a webcast of today's conference call can be found on 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 first quarter 2026 earnings call. On today's call, I will provide an update on the consistent progress we have made across our 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. David DeLucia, our CFO, will review the financials, after which we will open the call for your questions. Starting with slide three, I'd like to highlight our mid and late-stage programs and upcoming catalysts.
FG-3246 and FG-3180 are two exciting assets that are currently being evaluated in a phase II monotherapy trial 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. with anticipated interim analysis in the fourth quarter of 2026. roxadustat, which received orphan drug designation in lower risk myelodysplastic syndromes at the end of last year, is advancing as planned. We recently received constructive feedback from the FDA on the phase III design and are in the process of finalizing the protocol. As we have stated previously, we expect to initiate the phase III trial in the second half of 2026.
On the heels of our transformation over the past two years, we are laser-focused on continued execution of our strategy with upcoming catalysts for both clinical programs, a simplified capital structure, and a cash runway into 2028. Moving to our FG-3246 and FG-3180 program in mCRPC, where we believe significant opportunity exists to bring a new treatment for the 65,000 men in the U.S. diagnosed every year with drug-treatable castration-resistant metastatic disease. Slide five captures the uniqueness of CD46, a tumor-selective multifunctional target that helps tumors evade complement-dependent cytotoxicity. While there are a number of non-PSMA tumor antigen targets for metastatic prostate cancer, there are important characteristics of CD46 that distinguish it from these other targets. First, CD46 is highly expressed in prostate cancer and other tumors with limited expression in normal tissue.
In addition, CD46 is upregulated during tumor genesis as well as during the progression from localized castration-sensitive prostate cancer to metastatic castration-resistant prostate cancer. Further, it is estimated that 50%-70% of patients have high CD46 expressing tumors. Finally, CD46 is expressed more homogeneously with lower interpatient variability and with higher median expression in mCRPC tissues compared with PSMA, making it an attractive non-PSMA therapeutic target. Turning to slide six, FG-3246 is our CD46 targeting 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.
FG-3246 represents an androgen receptor agnostic approach, clinically differentiating it from other prostate cancer treatments currently in development, many of which target PSMA. In addition, the MMAE payload is clinically and commercially validated, serving as the payload for five currently marketed ADCs that in 2025 generated approximately $5 billion in worldwide revenue. The companion PET imaging agent, FG-3180, utilizes the same YS5 targeting antibody as FG-3246 and is also under clinical development with its own distinct IND. We believe that having a patient selection biomarker would not only allow us to better enrich the patient population in a future phase III trial, it could also enable differentiation of FG-3246 in the prostate cancer treatment paradigm.
FG-3180 could represent 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. Our development strategy aims to achieve a clinically differentiated profile in a competitive yet highly unsatisfied mCRPC market. Importantly, we're the only non-PSMA program in mid to late-stage development that combines a therapeutic with a companion PET imaging agent. I will now recap the clinical results for FG-3246 across two distinct trials. Starting with the phase I monotherapy trial, slide seven recaps the encouraging top-line results, 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, with PSA reductions of greater than 50% achieved in 36% of these patients. 20% of 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 mg per kg 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, shown on slide eight, combination of FG-3246 with enzalutamide demonstrated encouraging antitumor activity with seven months of median radiographic progression-free survival 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 very meaningful median rPFS of 10.1 months and demonstrated a PSA 50 response of 40%. An important insight gained from the IST is that there was a significant decrease in grade three or greater neutropenia compared to the phase I monotherapy trial due to the use of G-CSF prophylaxis. This finding is informative for the inclusion of G-CSF prophylaxis in the design of our ongoing phase II monotherapy study as we aim to substantially reduce the number of patients who require dose interruption or downward titration relative to the phase I trial with a goal of building upon the 8.7 months of rPFS demonstrated in the initial trial.
Moving to slide nine, the IST also provided us with important insights into the potential for FG-3180 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 administration of FG-3180, highlighting significant CD46 tumor expression. The table on the left shows that higher tumor uptake of FG-3180 was associated with PSA 50 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 PSA 50 response to FG-3246 versus those with a lower SUV, with a nominal P value that just missed being statistically significant.
Of note, this data demonstrates for the first time an association between CD46 expression and response to FG-3246. Further characterization and evaluation of FG-3180 is an important part of the ongoing phase II monotherapy trial. Altogether, the IST further validated important design elements of the ongoing phase II trial, which we believe has the potential to improve upon the median rPFS observed in the phase I monotherapy trial. Moving to slide 10, I'll now review the phase II monotherapy dose optimization trial design. This trial aims to enroll 75 patients in the post-1 ARPI pre-chemo setting across three dose levels to determine the optimal phase III dose based on efficacy, safety, and PK parameters.
As I previously mentioned, FG-3180 will be an integral part of the study as we seek to further explore what was demonstrated in the phase I-B/II combination trial, namely, to determine whether there is a correlation between CD46 expression and response to the ADC in this all-comers trial. An interim analysis of the open label trial is planned for the fourth quarter of this year and will include PSA 50, ORR, safety, PK, and exposure response data. Importantly, we expect mature rPFS data to become available in 2027 as patients continue their treatment with FG-3246 and the trial progresses towards completion.
On slide 11, I'd like to reiterate the three important steps we have taken with the design of the ongoing phase II monotherapy trial, which were further validated with the recently disclosed IST results as we aim to improve upon the 8.7 months of median rPFS demonstrated in the phase I monotherapy trial. Leveraging earlier evidence of an exposure response relationship, the phase II study is testing three of the highest doses from the phase I monotherapy study. Second, primary prophylaxis with G-CSF is being utilized to mitigate neutropenia, an approach which was successfully demonstrated in the phase II 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 patients in earlier lines of therapy versus the median five prior lines of therapy in the phase I trial. The 10.1 months of median rPFS demonstrated in the IST in patients who progress on only one prior ARPI underscores the potential of FG-3246 in this patient population. Together, with the insights from the IST, we believe that the 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 12 highlights the momentum we are experiencing with the ongoing phase II trial. We now have 21 sites activated in top-tier institutions across the U.S. and continue to actively screen and enroll patients. The sites are highly engaged, and we are encouraged about our progress to date.
While we aren't disclosing enrollment figures at this time, we are on track for the interim analysis in Q4 of this year. To summarize our prostate cancer program, we have an ongoing phase II monotherapy trial in the post-1 ARPI pre-chemo setting in mCRPC with important design elements that we believe could enable the ADC to build upon the 8.7 months of median rPFS demonstrated in the phase I trial. We look forward to the interim analysis in the fourth quarter of this year. Shifting gears to our roxadustat program, slide 14 highlights the unmet need and the potential for roxadustat in the approximately 49,000 patients with anemia associated with lower risk MDS in the U.S. 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 15, I would like to 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 roxadustat 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, roxadustat 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. Moving to slide 16. Based on these results, our target indication is for the treatment of anemia in patients with lower risk MDS who are refractory to or ineligible for prior ESA treatment. We believe roxadustat has real potential to elevate the standard of care across multiple treatment lines. In addition, we believe there is a unique opportunity to demonstrate transfusion independence across both RS positive and RS negative patients. Based on a recently conducted opportunity assessment that was informed by primary research with practicing clinicians, we believe roxadustat has the potential to penetrate both RS positive and RS negative segments.
We further believe that the opportunity in the RS negative population is substantial, given that luspatercept, the market leading brand in the treatment of lower risk MDS, has not demonstrated clinically differentiated efficacy in the segment of the lower risk MDS population. Moving to slide 17. In April 2026, we received clinical and statistical information requests from the FDA, which were highly constructive to the phase III design. We've responded to the agency and are in the last stages of finalizing the phase III protocol. Of note, the final protocol will specify a primary endpoint of eight-week transfusion independence, with key secondary endpoints of 12 and 16-week transfusion independence. We continue to anticipate the initiation of the study in the second half of 2026, while in parallel continuing to explore the opportunity to develop roxadustat internally or with a strategic partner.
To summarize on slide 18, given the sizable unmet need in lower risk MDS, the dearth of oral treatments available or in late-stage development, the potential to demonstrate efficacy in RS negative patients, and the recently granted orphan drug designation, roxadustat represents a compelling commercial opportunity for Kyntra Bio. With that, I will now turn the call over to Dave to discuss the company's financials. Dave?
Thank you, Thane. For the first quarter of 2026, total revenue was $3.7 million compared to $2.7 million for the same period in 2025. Total operating costs and expenses for the first quarter of 2026 were $17.6 million compared to $17.7 million for the first quarter of 2025. R&D expenses for the first quarter of 2026 were $7.6 million compared to $9.2 million in the first quarter of 2025. SG&A expenses for the first quarter of 2026 were $5.9 million compared to $8.1 million in the first quarter of 2025.
During the first quarter of 2026, we recorded a net loss from continuing operations of $15.1 million or $3.74 net loss per basic and diluted share, compared to a net loss of $16.8 million or $4.15 net loss per basic and diluted share one year ago. Shifting towards cash. As of March 31st, we reported $100.3 million in cash equivalents, investments, and accounts receivable. We expect the company to have cash runway into 2028, enabling us to continue to invest in our U.S. pipeline opportunities. Thank you, and I will now turn the call back over to Thane.
Thank you, Dave. In closing, we are continuing to make important progress across our pipeline and are well-positioned to support multiple clinical milestones from now into 2028. We will continue our disciplined execution of the FG-3246 and FG-3180 program with expected interim analysis from the phase II mono-therapy trial in the fourth quarter of 2026 and anticipate initiation of the phase III trial for roxadustat in lower risk MDS in the second half of 2026. With that, 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 one one on your telephone and wait for a name to be announced. To withdraw your question, please press star one one again. Please stand by while we compile the Q&A roster. One moment for our first question. Our first question comes from the line of Alex Ramsey from William Blair. Your line is open.
Hello, this is Alex on for Andy Hsieh. Thank you for taking our question. Just thinking about the fourth quarter updates, what do you want to see for FG-3180 in phase II to use it in phase III? You just want to see that P value be statistically significant or are there other metrics you plan to look at to make that decision? Related, what role could FG-3180 serve in the phase III, even if you decide to not enroll patients based on uptake of FG-3180? Could you still use it as a way to kind of look at CD46 expression, or would you just not incorporate it at all into the design?
Yeah. Alex, thanks for the question. This is Thane. I'll answer first and then Carol , if you've got thoughts in addition to mine, please chime in. First, as it relates to, you know, the parameters that we're gonna be looking at, with respect to the fourth quarter of this year and the interim analysis, Alex, I think that's what you were asking. Is that correct? Alex? Maybe I lost her. As we've stated before, the interim analysis, we're gonna be looking at, you know, some of the typical measures, PSA 50, ORR, duration of response, dose response, PK parameters, things of that nature, which will then inform our decision to continue.
If we do continue, do we continue with all three doses or perhaps are we seeing something with a particular dose that would allow us or enable us to perhaps drop that dose and then accrue those patients in the remaining doses. What we've also said before is that we've got a hurdle that is consistent with this composite response of ORR and PSA 50 that we saw in the phase I monotherapy trial. The reason that is the case is because we are most interested in getting to the more fully mature rPFS data in 2027. You know, clearly, if we see either safety or efficacy results that are not meeting our expectations, then we'll be able to time.
However, we do expect this given the hurdle that we've set, we do expect the asset to continue on until we see the more fully mature rPFS data in 2027. Carol, anything to add there before we hit the question on 3180?
Nothing to add. Thank you.
Okay. As it relates to FG-3180 and, in the phase III portion of the program, you know, clearly if we see a correlation between expression of CD46 and the response to the ADC across the 75 patients in the phase II trial, and we'll also be able to then compile that data across 75 patients with the 25 patients worth of data we have from Dr. Aggarwal's IST. That'll be pretty informative of the potential correlation between the expression of the target and response to the ADC. That would allow us, we think, to be able to then better select and target patients who are higher expressers of CD46 for the phase III portion of the program.
If we don't see a correlation, we do think it would still be instructive to collect the expression data. Clearly, when you're moving from a phase II trial of 75 patients to a phase III trial of 400 patients or more, you know, the more data that we have, obviously, the more informed we're gonna be with respect to characterization of the target. You know, if we see a strong rPFS signal in the phase II trial in an all-comer sort of population, in other words, if we don't see a correlation, we do think it would be instructive to capture CD46 data with the CD46 PET imaging agent. It would be in an all-comers population in the phase III part of the program.
Carol, thoughts on that one?
Just to reiterate, if supported by phase II data, we would consider using FG-3180 as a patient selection biomarker for the phase III pivotal trial so that we would conduct this trial in a CD46 high population if supported by phase II data.
Thanks, Carol.
That's super helpful. Just to clarify, and sorry I was on mute earlier. Just to clarify, basically in phase II, you really just want that P value to be statistically significant to kind of confirm that correlation?
Yeah, that's exactly right. Yeah, you know, we've got the SAP that's in place right now. You know, given the open label nature of the trial, you know, which is a really positive part of this phase II design, is that, you know, we're gonna be informed of these CD46 expression patterns early in the course of this trial. We'll be able to then start to look at correlation, you know, early with PSA 50, then over time with rPFS. Yeah, we'll be looking at, you know, to see if there is a correlation. We'll be looking to ensure that the statistics support that.
Okay, perfect. Thanks so much. Appreciate it.
Thank you. Our next question will come from line of Matthew Keller from H.C. Wainwright & Co. Your line is open.
Hey, everyone. Thanks for the update, and thanks for taking our questions. Kinda related to the previous questions, but I was wondering, since you presented the IST data, if you've received any additional feedback, or any change in the amount of inbounds you've had, particularly related to FG-3180. My second question, just briefly, is do you know when we can expect maybe more details related to the roxadustat phase III trial?
Yeah. Thanks, Matt, for the questions. In terms of additional inbounds on FG-3180, I won't comment on, you know, any business development activities which are ongoing at this point in time. Clearly, you know, we do believe that that particular data point from the IST is one of the most intriguing and thought-provoking data points from the IST. You know, the mitigation of neutropenia with G-CSF, an important finding that we've now incorporated into the phase II design. Then the data that we've seen with respect to that association between CD46 expression and response to the ADC, not only is intriguing for us, but it's intriguing for others as well. I'll leave it at that. Carol, any additional thoughts on that one?
Just to build on that, we have had very encouraging interactions with investigators in the community at ASCO GU. We're also seeing the excitement reflected in the current enrollment activities at our 21 active sites. That speaks a lot to that as well. Thank you.
In terms of roxadustat phase III and, you know, sharing additional information, you know, we'll continue to keep you, the investment community updated. We probably won't be commenting any further with respect to our phase III protocol. The information and the feedback that we got through the information request from the FDA, as I said, were very instructive, both on the statistical as well as on the clinical side. We are very, very close to finalizing the protocol. We've selected the CRO for the trial, and we continue to have conversations about how we ultimately conduct the trial, whether it's on our own or whether it's with a strategic. We'll just keep Matt, you and others posted as we continue to make progress.
Yep, perfect. Thank you so much.
Okay.
Once again, that's star one one for questions, star one one. I'm not showing any further questions in the queue. I'd like to turn it back over to Thane for any closing remarks.
Yeah. Thanks for joining us today for the first quarter earnings call and for your interest in Kyntra Bio. Enjoy the rest of your day. Thanks, everyone.
Thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.