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DATE

May 11, 2026

CALL PARTICIPANTS

  • Chief Executive Officer — Thane Wettig
  • Chief Financial Officer — David DeLucia
  • Vice President, Product Development — Carol Gaddum

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TAKEAWAYS

  • Total Revenue -- $3.7 million, reflecting a $1 million increase from the same period in 2025.
  • Total Operating Costs and Expenses -- $17.6 million, essentially flat compared to $17.7 million in 2025.
  • Research and Development Expenses -- $7.6 million, down from $9.2 million in the prior year.
  • SG&A Expenses -- $5.9 million compared to $8.1 million a year ago.
  • Net Loss from Continuing Operations -- $15.1 million, or a $3.74 loss per share, versus $16.8 million, or a $4.15 loss per share, in 2025.
  • Cash, Cash Equivalents, Investments, and Accounts Receivable -- $100.3 million as of March 31, with management stating a cash runway into 2028.
  • FG3246 Phase 1 Monotherapy Results -- Median RPFS of 8.7 months and PSA reductions of 50% or greater in 36% of patients; 20% overall response rate with 7.5 months median duration of response at 2.7 mg/kg dose.
  • FG3246 with Enzalutamide (Phase 1b/2 IST) -- Median RPFS of 7 months for all patients and 10.1 months for those with only one prior ARPI; PSA50 response rate of 40% in the latter group; Grade 3+ neutropenia decreased with G-CSF prophylaxis.
  • FG3180 PET Imaging Biomarker -- Elevated SUV associated with higher PSA50 response rates; nominal p-value for the correlation missed statistical significance.
  • Phase 2 Monotherapy Dose Optimization Trial -- Enrolling 75 patients across three doses; interim analysis planned for fourth quarter, including endpoints such as PSA50, ORR, safety, PK, and exposure–response.
  • Roxadustat Post Hoc Phase 3 Analysis -- 36% achieved transfusion independence for at least eight weeks versus 7% in placebo (nominal p-value: 0.041) in high transfusion burden subgroup.
  • Roxadustat Regulatory Status -- Orphan drug designation for lower-risk MDS and constructive FDA feedback shaping the final protocol for an anticipated 2026 Phase 3 trial initiation.
  • Clinical Operations Update -- 21 sites activated in major U.S. institutions for the Phase 2 prostate cancer trial and active screening proceeding as planned.
  • Capital Structure -- Management emphasized a "simplified capital structure" and reiterated commitment to pipeline investment.

SUMMARY

Kyntra Bio (KYNB 0.58%) reported higher revenue and lower operating expenses, narrowing its quarterly net loss. The company highlighted encouraging efficacy signals from its FG3246 antibody-drug conjugate program and associated PET companion, including reduction in neutropenia through design changes. Management described progress toward launching Phase 3 trials for roxadustat in lower-risk MDS, supported by new analyses and ongoing FDA interactions. Site activation and enrollment for the Phase 2 prostate cancer trial remain on track, with an interim analysis slated for the fourth quarter. Balance sheet strength was underscored by $100.3 million in cash and investments, anticipated to fund development plans into 2028.

  • CEO Wettig described a "hurdle that is consistent with this composite response of ORR and PSA50 that we saw in the Phase 1 monotherapy trial" as the benchmark for interim success and stated that mature RPFS data will drive further decision-making.
  • Management indicated that a correlation between CD46 expression and response to FG3246, if validated, could be leveraged to optimize patient selection for Phase 3.
  • Discussion confirmed "very instructive," FDA engagement contributing to protocol finalization for the upcoming roxadustat Phase 3 study.
  • Vice President Gaddum noted enthusiasm among clinical investigators, reflected in ongoing enrollment and interest following recent data presentations.

INDUSTRY GLOSSARY

  • mCRPC: Metastatic castration-resistant prostate cancer, an advanced prostate cancer subtype unresponsive to hormonal therapy.
  • PSMA: Prostate-specific membrane antigen, a cell surface marker commonly targeted in prostate cancer therapies.
  • ADC: Antibody-drug conjugate, a targeted cancer therapy combining an antibody with a cytotoxic agent.
  • RPFS: Radiographic progression-free survival, the time patients live without radiological disease progression.
  • PSA50: A prostate-specific antigen reduction of 50% or greater from baseline, a typical prostate cancer response metric.
  • ORR: Overall response rate, the proportion of patients with tumor size reduction per standard criteria.
  • G-CSF: Granulocyte colony-stimulating factor, a protein used to reduce the risk of neutropenia during cancer treatment.
  • ESA: Erythropoiesis-stimulating agent, a drug class used to reduce anemia in certain conditions.
  • RS-positive/RS-negative: Refers to the presence or absence of ring sideroblasts, a marker used to stratify types of myelodysplastic syndrome.
  • SUV: Standardized uptake value, a quantitative PET imaging measure for tracer concentration in tissues.
  • IST: Investigator-sponsored trial, a clinical study led and managed by external investigators unaffiliated with company operations.

Full Conference Call Transcript

Gaia Vasiliver-Shamis: Good afternoon, everyone, and thank you for joining us today to discuss Kyntra Bio, Inc.’s first quarter 2026 financial and business results. I am Gaia Vasiliver-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, Inc.

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, Inc.’s filings with the SEC, including our most recent Form 10-K and Form 10-Q.

Kyntra Bio, Inc. 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 update and a webcast of today’s conference call can be found in the investors section of Kyntra Bio, Inc.’s website at kimtrobio.com. With that, I would like to turn the call over to the CEO, Thane Wettig.

Operator: Thane?

Thane Wettig: 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 FG3246, our potential first-in-class antibody-drug conjugate targeting CD46, and its companion PET imaging agent in metastatic castration-resistant prostate cancer, and 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 three, I would like to highlight our mid- and late-stage programs and upcoming catalysts.

FG3246 and FG3180 are two exciting assets that are currently being evaluated in a Phase 2 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 United States, with an anticipated interim analysis in 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 3 design and are in the process of finalizing the protocol. As we have stated previously, we expect to initiate the Phase 3 trial in 2026.

On the heels of our transformation over the past two years, we are 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 FG3246 and FG3180 program in mCRPC, where we believe significant opportunity exists to bring a new treatment for the approximately 65,000 men in the United States 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 tumorigenesis as well as during the progression from localized castration-sensitive prostate cancer to metastatic castration-resistant prostate cancer. Further, it is estimated that 50% to 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, FG3246 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-selected 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. 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, FG3180, utilizes the same YS5-targeting antibody as FG3246 and is also under 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 3 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. Our development strategy aims to achieve a clinically differentiated profile 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.

I will now recap the clinical results for FG3246 across two distinct trials. Starting with the Phase 1 monotherapy trial, slide seven recaps the encouraging top-line results 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 50% or greater achieved in 36% of these patients. Twenty percent 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/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 1b/2 investigator-initiated study at UCSF shown on slide eight, the combination of FG3246 with enzalutamide demonstrated encouraging antitumor activity, with 7 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 FG3246 and enzalutamide achieved a very meaningful median RPFS of 10.1 months and demonstrated a PSA50 response of 40%.

An important insight gained from the IST is that there was a significant decrease in Grade 3 or greater neutropenia compared to the Phase 1 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 2 monotherapy study, as we aim to substantially reduce the number of patients who require dose interruption or downward titration relative to the Phase 1 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 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 administration of FG3180, highlighting significant CD46 tumor expression. The table on the left shows that higher tumor uptake of FG3180 was associated with 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 PSA50 response to FG3246 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 FG3246.

Further characterization and evaluation of FG3180 is an important part of the ongoing Phase 2 monotherapy trial. Altogether, the IST further validated important design elements of the ongoing Phase 2 trial that we believe has the potential to improve upon the median RPFS observed in the Phase 1 monotherapy trial. Moving to slide 10, I will now review the Phase 2 monotherapy dose optimization trial design. This trial aims to enroll 75 patients in the post–one ARPI, pre-chemo setting across three dose levels and determine the optimal Phase 3 dose based on efficacy, safety, and PK parameters.

As I previously mentioned, FG3180 will be an integral part of the study as we seek to further explore what was demonstrated in the Phase 1b/2 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 PSA50, ORR, safety, PK, and exposure–response data. Importantly, we expect mature RPFS data to become available in 2027 as patients continue their treatment with FG3246 and the trial progresses towards completion.

On slide 11, I would like to reiterate the three important steps we have taken with the design of the ongoing Phase 2 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 1 monotherapy trial. First, leveraging earlier evidence of an exposure–response relationship, the Phase 2 study is testing three of the highest doses from the Phase 1 monotherapy study. Second, primary prophylaxis with G-CSF is being utilized to mitigate neutropenia, an approach that was successfully demonstrated in the Phase 2 portion of the recently disclosed IST.

The mitigation of neutropenia could enable more consistent exposure to the ADC, 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 prior lines of therapy in the Phase 1 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, we believe that the design elements have the potential to improve upon the Phase 1 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 2 trial. We now have 21 sites activated in top-tier institutions across the United States and continue to actively screen and enroll patients. The sites are highly engaged, and we are encouraged about our progress to date. While we are not 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 2 monotherapy trial in the post–one 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 1 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 United States. 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 3 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 this 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 3 design. We have responded to the agency and are in the last stages of finalizing the Phase 3 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 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, Inc. With that, I will now turn the call over to Dave to discuss the company’s financials.

David DeLucia: 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 a $3.74 net loss per basic and diluted share, compared to a net loss of $16.8 million, or a $4.15 net loss per basic and diluted share, one year ago. Now shifting to cash, as of March 31, we reported $100.3 million in cash, cash equivalents, investments, and accounts receivable. We expect the company to have a 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.

Thane Wettig: 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 FG3246 and FG3180 program, with expected interim analysis from the Phase 2 monotherapy trial in 2026, and anticipate initiation of the Phase 3 trial for roxadustat in lower-risk MDS in 2026. With that, I would now like to turn the call over to the operator for Q&A.

Operator: Thank you. Wait for your name to be announced. To withdraw your question, please press 11 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.

Analyst: Hello. This is Alex on for Andy Hsieh. Thank you for taking our question. So just thinking about the fourth quarter update, what do you want to see for 3180 in Phase 2 to use it in Phase 3? Do 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? And then related, what role could 3180 serve in the Phase 3 even if you decide not to enroll patients based on uptake of 3180? Could you still use it as a way to look at CD46 expression, which is not incorporated at all into the design?

Thane Wettig: Yeah, Alex, thanks for the question. This is Thane. I will answer first, and then, Carol, if you have thoughts in addition to mine, please chime in. As it relates to the parameters that we are going to be looking at with respect to the fourth quarter of this year and the interim analysis—Alex, I think that is what you were asking, is that correct? As we stated before, at the interim analysis we are going to be looking at some of the typical measures: PSA50, ORR, duration of response, dose–response, PK parameters, things of that nature, which will then inform our decision to continue.

And 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 drop that dose and accrue those patients in the remaining doses? What we have also said before is that we have a hurdle that is consistent with this composite response of ORR and PSA50 that we saw in the Phase 1 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. Clearly, if we see either safety or efficacy results that are not meeting our expectations, then we will be able to act accordingly.

However, given the hurdle that we set, we do expect the asset to continue until we see the more fully mature RPFS data in 2027. Carol, anything to add there before we hit the question on 3180? Okay, and then as it relates to FG3180 and the Phase 3 portion of the program, if we see a correlation between expression of CD46 and response to the ADC across the 75 patients in the Phase 2 trial, we will also be able to compile that data across the 75 patients with the 25 patients’ worth of data we have from Dr.

Agarwal’s IST, and that will 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 better select and target patients who are higher expressers of CD46 for the Phase 3 portion of the program. If we do not see a correlation, then we still think it would be instructive to collect the expression data. Clearly, when you are moving from a Phase 2 trial of 75 patients to a Phase 3 trial of 400 patients or more, the more data that we have, the more informed we are going to be with respect to characterization of the target.

If we see a strong RPFS signal in the Phase 2 trial in an all-comers population—in other words, if we do not see a correlation—then we do think it would be instructive to capture CD46 data with the CD46 PET imaging agent, but it would be in an all-comers population in the Phase 3 part of the program. Carol, thoughts on that one?

Carol Gaddum: Nothing to add. Thank you.

Analyst: Basically, in Phase 2, you really just want that p-value to be statistically significant to confirm that correlation?

Thane Wettig: Yeah, that is exactly right. We have the SAP in place right now and, given the open-label nature of the trial—which is a really positive part of this Phase 2 design—we are going to be informed of these CD46 expression patterns early in the course of this trial. We will be able to start to look at correlation early with PSA50 and then, over time, with RPFS. We will be looking to see if there is a correlation, and we will be looking to ensure that the statistics support that.

Analyst: Okay, perfect. Thanks so much. Appreciate it.

Operator: Thank you. And our next question will come from the line of Matthew Keller from H.C. Wainwright. Your line is open.

Analyst: Hey, everyone. Thanks for the update, and thanks for taking our questions. So, kind of related to the previous question, but I was wondering, since you presented the data, if you have received any additional feedback or any change in the amount of inbounds you have had, particularly related to 3180? And then my second question, just briefly, is do you know when we can expect more details related to the roxa Phase 3 trial?

Thane Wettig: Yeah, thanks, Matthew, for the questions. In terms of additional inbounds on 3180, I will not comment on any business development activities, which are ongoing at this point in time. Clearly, we do believe that particular data point from the IST is one of the most intriguing and thought-provoking data points from the IST. The mitigation of neutropenia with G-CSF is an important finding that we have now incorporated into the Phase 2 design. And then the data that we have seen with respect to the association between CD46 expression and response to the ADC not only is intriguing for us, but it is intriguing for others as well, so I will leave it at that.

Carol, any additional thoughts on that one?

Carol Gaddum: Just to build on that, we have had very encouraging interactions with investigators in the community at ASCO GU, and we are also seeing the excitement reflected in the current enrollment activities at our 21 active sites, which speaks a lot to that as well. Thank you.

Thane Wettig: And then, in terms of roxa Phase 3 and sharing additional information, we will continue to keep you and the investment community updated. We probably will not be commenting any further with respect to our Phase 3 protocol specifics. 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 have selected the CRO for the trial, and we continue to have conversations about how we ultimately conduct the trial, whether it is on our own or with a strategic partner.

We will keep you and others posted as we continue to make progress.

Analyst: Yep, perfect. Thank you so much.

Operator: Once again, it is 11 for questions. 11. I am not showing any further questions in the queue. I would like to turn it back over to Thane for any closing remarks.

Thane Wettig: Thanks for joining us today for the first quarter earnings call and for your interest in Kyntra Bio, Inc. Enjoy the rest of your day. Thanks, everyone.

Operator: Thank you for your participation in today’s conference. This does conclude the program. You may now disconnect. Everyone, have a great day.