KYNB

Image source: The Motley Fool. Thursday, Aug. 13, 2026 at 5:00 p.m. ET LifeSci Advisors - Gaia Shamis Chief Executive Officer - Thane Wettig Chief Financial Officer - David DeLucia Vice President of Product Development - Carol Gaddum Operator: Please be advised that today's conference is being recorded. I would now like to hand the conference over to your speaker today, Gaia Shamis of LifeSci Advisors. Please go ahead. Gaia Shamis: 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? Thane Wettig: 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 three, 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 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 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. First, we are testing three of the highest doses from the phase I monotherapy study, 1.8, 2.4, and 2.7 mg/kg. Second, primary prophylaxis with G-CSF is being utilized to mitigate neutropenia, an approach which was successfully implemented in the phase II portion of the IST. We believe reducing the incidence of Grade 3 or greater neutropenia should lead to fewer dose interruptions or adjustments, extending the duration of therapy and enabling more consistent exposure to the ADC of FG-3246. Third, we are enrolling patients who are earlier in the progression of mCRPC 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 progressed on only one prior ARPI underscores the potential of FG-3246 in this patient population. Together, we believe these design elements have the potential to improve upon the phase I results and achieve a median rPFS of 10 months or greater, which can be viewed as a threshold for commercial competitiveness. Slide 10 shows the sites who are participating in the ongoing phase II trial. We now have 23 sites live at top-tier U.S. institutions, and we continue to be encouraged by our progress to date. We remain on track for the interim analysis of 36 patients in the fourth quarter of this year. To conclude this update on FG-3246, we are actively enrolling patients in our phase II monotherapy trial in the post one ARPI pre-chemo mCRPC setting with important design elements in place that we believe could enable FG-3246 to surpass 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. Moving on to the roxadustat lower risk myelodysplastic syndromes program on slide 13. There are approximately 50,000 patients with anemia associated with lower risk MDS in the U.S., with current therapies effective in less than 50% of these patients. With no oral options currently on the market or in late-stage development, there is a significant opportunity for an effective, durable, convenient oral treatment that works across multiple lines of therapy. Slide 14 highlights why we believe roxadustat can be that treatment. In a post hoc analysis of high transfusion burden patients from our previous phase III MATTERHORN study, using the international working group definition for high transfusion burden of four or more RBC units in two consecutive eight-week periods, we saw that 36% of patients treated with roxadustat achieved transfusion independence for at least eight straight 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. Turning to slide 15, based on these results, our target indication is intended to be for the treatment of anemia in patients with lower risk MDS who are refractory to or ineligible for prior ESA treatment, where we believe roxadustat can raise the standard of care across multiple lines of treatment. We believe we also have a unique opportunity to demonstrate transfusion independence across both RS+ and RS- patients. As presented in our most recent disclosure at EHA, the European Hematology Association, in a post hoc analysis of the phase III MATTERHORN study, roxadustat demonstrated similar rates of transfusion independence across both RS+ and RS- patients. Primary research that we have conducted with practicing clinicians indicates that roxadustat has the potential to be a useful treatment in both of these patient segments. The RS- opportunity, which represents majority of lower risk MDS patients, is especially relevant given 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 and is not indicated for use in the second-line setting in RS- patients. We believe that demonstrating similar efficacy across the entire patient population could position roxadustat favorably in the treatment paradigm of lower risk MDS. Slide 16 provides an overview of the phase III trial. Following our interactions with the FDA, we have now finalized the protocol for the phase III study, which includes a primary endpoint of 8-week transfusion independence over the first 24 weeks of the trial, with key secondary endpoints of 12, 16, and 24-week transfusion independence over 48 weeks. We continue to explore the opportunity to develop roxadustat internally or with a strategic partner, which aligns with our goal of initiating the study in the fourth quarter of 2026. To summarize the roxadustat opportunity in lower risk MDS on slide 17, with a substantial unmet need, no oral therapeutic options on the market or in late development, significant potential in RS- patients, and an Orphan Drug Designation in hand, we see roxadustat as a compelling commercial opportunity. We have continued to make important progress with the phase III enabling activities. With that, I will now turn the call over to Dave to discuss the company's financials. Dave? David DeLucia: Thank you, Thane. For the second quarter of 2026, total revenue was -$1.5 million compared to $1.3 million for the same period in 2025. Total operating costs and expenses for the second quarter of 2026 were $16.1 million compared to $13.4 million for the second quarter of 2025. R&D expenses for the second quarter of 2026 were $6.8 million compared to $5.9 million in the second quarter of 2025. SG&A expenses for the second quarter of 2026 were $9.3 million compared to $7.1 million in the second quarter of 2025. During the second quarter of 2026, we recorded a net income from continuing operations of $12 million, or $2.96 net income per basic and diluted share, compared to a net loss of $13.7 million, or $3.38 net loss per basic and diluted share one year ago. Now shifting towards cash. As of June 30th, we reported $95.7 million in 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. I will now turn the call back over to Thane. Thane Wettig: Thank you, Dave. We entered the second half of 2026 with promising momentum. We will continue our disciplined execution of the FG-3246 and FG-3180 program with results from the interim analysis of the phase II monotherapy trial expected in the fourth quarter of 2026, and continue the phase III enabling activities for roxadustat with the goal of initiating the phase III trial in lower risk MDS in the fourth quarter of 2026. With that, I would now like to turn the call over to the operator for Q&A. Operator: Certainly. As a reminder, to ask a question, please press star one on your telephone and wait for your name to be announced. To withdraw your question, please press star one again. Please stand by while we compile our Q&A roster. Our first question will come from the line of Alex Ramsey of William Blair. Your line is open. Alex Ramsey: Hi, this is Alex on for Andy. For the upcoming phase III trial of roxadustat, the dosing regimen begins with 2.5 mg/kg with potential for titrating up to 3.5. We were just wondering how that determination is made, and if it's based on tolerability or efficacy, and how long after starting the treatment the assessment is made. What the titration interval is from both a timing and a dosing perspective. Thane Wettig: Yeah. Thanks, Alex, for the call. I am going to hand that question over to Carol Gaddum, our VP of Product Development. Carol? Carol Gaddum: Thank you for the question. Up titration or down titration is based on an assessment of benefit and risk, as you have highlighted, and the assessment is, or a change in dose is possible every six weeks based on what we see from a benefit and risk perspective. Alex Ramsey: Perfect. Thank you so much. Is it straight from 2.5 to 3.5 mg/kg if they go up in dose, or is there some interval in between? Or some- Carol Gaddum: There are some intervals in between. There are some intervals in between. Alex Ramsey: Okay. Carol Gaddum: Yes. Alex Ramsey: Okay, perfect. Thank you so much. Thane Wettig: Yeah. Alex, there will be very specific guidance to the sites on the titration either up or down based upon a number of factors including hemoglobin level and the rate of rise of that hemoglobin level as well. Alex Ramsey: Perfect. Thank you so much. Operator: Our next question will be coming from the line of Matthew Keller of H.C. Wainwright. Your line is open. Matthew Keller: Hey, good afternoon, everyone. Thanks for taking our questions. I guess on the roxadustat program as well. First, I was wondering if you could remind us how contingent are you starting the phase III on a partner? Then a follow-up to that, I was wondering is how has the MATTERHORN data changed your calculus at all on potentially partnering that program? Thane Wettig: Hey, thanks, Matt, for the question. The start of the phase III, as we've stated previously, we are undergoing both the opportunity to develop internally as well as partner the program. To develop internally, we would have to bring in capital in order to do that. That's a consideration while we also evaluate strategic partners as well. We're running a parallel path with both of these. At the end of the day, we're going to make the decision that we believe is in the best interest of shareholders. There are some dynamics in play related to economics. If you think about the license that we wholly own in North America and South America, that was a license that was previously held by AstraZeneca during the development of the CKD program. When we negotiated those rights back from AstraZeneca, if we were to develop roxadustat on our own and commercialize on our own, we would owe AstraZeneca a mid-single-digit royalty on net sales. If we were to partner the program with a strategic and somebody else were to develop and commercialize, AstraZeneca would then be entitled to 35% of any economics that would accrue to Kyntra Bio. That's one consideration from an economic perspective. Clearly, there are strategic and operational considerations that we continue to evaluate. As I said, we're going to ultimately make the call that we believe is in the best interest of shareholders. Matthew Keller: Yeah, it totally makes sense. Then can you comment at all about how the RS data is maybe playing into that, if at all? If I may, kind of an adjacent question, did the RS data also influence the potential phase III design at all? Sorry, I'm going to pepper you with a couple there. Thane Wettig: No, it's a great question. The RS dynamic with respect to RS+ and RS-, there's clearly a larger unmet need in the marketplace for RS- patients given the fact that luspatercept has not been able to really show any sort of a benefit relative to ESAs in that particular patient population, and the fact they're not indicated in the second-line setting for RS- patients. The understanding of that dynamic obviously plays into how we think about the opportunity, how we think about the clinical design, how we think about the ultimate forecast should we be successful in the phase III trial. We're going to make sure that we enroll a requisite number of both RS+ and RS- patients in the phase III trial so that we can have the power to be able to demonstrate that roxadustat works across both of those patient populations. But the RS- opportunity or the MATTERHORN data, we'd be pursuing this regardless of the opportunity for roxadustat to perhaps show a differential benefit in RS- patients relative to RS+ patients. But it clearly does give us, we think, a really nice commercial opportunity across both segments, but especially in the RS- population, which makes up more than 50% of the total patients who have lower-risk myelodysplastic syndrome. Did that answer your question, Matt? Matthew Keller: It absolutely did. Thank you so much for the color. I really appreciate it. Thane Wettig: Yeah. David or Carol, anything to add to that? Carol Gaddum: Thank you. The only thing I would add is, you asked around how MATTERHORN informed the phase III design, it has obviously been a significant driver of the phase III design. Went through a comprehensive analysis of what variables were driving outcomes, roxadustat versus placebo, and isolated transfusion burden as the key variable, and have designed the phase III trial accordingly. To Thane's point, the analysis also shows that roxadustat improves transfusion independence and hemoglobin across RS+ and RS-. That is also reflected in the phase III design. Matthew Keller: Makes sense. Thank you. Operator: Our next question will be coming from the line of Michael King of Rodman & Renshaw, LLC. Your line is open. Michael King: Thanks for taking the question, guys. If I could, I would like to pivot to FG-3246 and FG-3180. Couple of questions on the program. I am just curious how you guys look at it as far as, I know it is one to two prior lines and one prior ARPI, but I am just curious what you anticipate the enrollment might be for individuals who have been treated with Lutetium-177. Whether you can enrich enrollment for that population. The reason I am asking is I am trying to think about whether there is any element of the design of the phase II that could propel you towards some kind of an accelerated approval strategy. Thane Wettig: Yeah, it's a great question, Mike, and I appreciate the question. I'll go ahead and kick it off, and then Carol, I'll hand it over to you for additional commentary. To your point, we clearly are allowing prior Pluvicto-treated patients into the trial. At the outset of the trial, we kind of had an estimate as it relates to what percent of patients were going to be previous Pluvicto-treated patients. This far into the trial, while we're not disclosing our enrollment stats yet, what we can say is about 30% of patients who have been enrolled into the trial and randomized were previously treated with Pluvicto, and we've got a pre-specified analysis based upon prior Pluvicto exposure or not so that we've got that built into the SAP so that we will be able to clearly determine is there any sort of a differential impact or effect from FG-3246 based upon prior Pluvicto exposure. Haven't really thought about the ability to go for accelerated approval in that particular patient population if we showed a really nice benefit, but it's an interesting thought. Ultimately, we're going to be data-driven based upon the outcome of the phase II trial. Carol, go ahead. Carol Gaddum: No additions from my side. Michael King: I just wonder, has there been any inflection? Because, I know it's early days, but Novartis just recently received first-line indication. I wonder if that 30% proportion might increase going forward from here. Thane Wettig: Yeah, it very well could. I think what we've found is that you do not see an immediate or instantaneous adoption, especially in the area of therapy where ARPIs have been really cemented as standard care, both in the castration-sensitive phase as well as if they have not been previously treated with an ARPI in the castration-resistant phase as well. It is something we will continue to keep an eye on. We are closely evaluating the patients who are enrolled to understand, are we seeing an inflection in previously Pluvicto-treated patients? It is clearly an important consideration for us. Carol Gaddum: Yeah, I would just add to that there is obviously the dynamic around enrollment, and that is obviously also highly driven by the sites in particular and the treatment practice at the individual sites. As we think about the design of a global phase III, we are obviously very closely monitoring market shares in the pre and mCRPC setting and then the metastatic setting to understand eligibility criteria, but also how you set up the control arm and what is the appropriate prior line of therapy. So point well taken around there being a lot of movement in that space. Michael King: Yeah. Sorry to keep belaboring this point, but one other question I wanted to ask, and that is I know PET imaging is your key guide towards response. I am wondering, is it possible to get both pre and post-treatment biopsy from these individuals? Because I am just curious about the levels of expression of PSMA prior to therapy and post-therapy to see if there is any correlation with the level of expression with PSMA. Are you going to be more active sort of in the post-PSMA setting, less active, or indifferent to PSMA? Thane Wettig: No, thanks, Mike. Carol, you want to take that one? Carol Gaddum: Sure. Yeah. It is certainly a very interesting scientific question, and we are doing a lot in terms of tissue collection, PSMA scans, PET scans, and our FG-3180 scans as much as possible to understand how it evolves over time. As you can appreciate, there are limitations as to the burden that you can put on patients. Michael King: Sure. Carol Gaddum: This is a bit more on a best effort basis, but it is certainly a key question to address. What I would also just say is, in this disease area, the tissue availability is limited given the disease often just being bone disease and also tissue availability if it is soft tissue disease. So we are coming up against some challenges here in terms of disease, but we are doing all we can to address that scientific question. Michael King: Well, I know the Prostate Cancer Working Group just updated their guidelines to encourage the use of ctDNA. I do not know, are you going to be looking at ctDNA in these patients? Carol Gaddum: Correct. Yes, we are. Thane Wettig: Absolutely. We definitely are. In fact, in the phase I monotherapy trial, there was a really nice ctDNA effect with FG-3246. Michael King: Okay. All right. I think I've exhausted my questions for now. Thank you. Thane Wettig: I appreciate it, Mike. Operator: Our next question will come from the line of Jay Olson of Oppenheimer. Your line is open, Jay. Jay Olson: Oh, hey. Congrats on all the progress, and thanks for taking our questions. We had a couple questions, starting with FG-3246. Can you just talk about how you're thinking of positioning FG-3246 as a differentiated non-PSMA approach to mCRPCs? Is the greatest opportunity in PSMA-low or PSMA-negative patients, or do you see CD46 targeted therapy as potentially complementary to PSMA-directed approaches? Then just on roxadustat from a longer-term perspective, how are you thinking about eventually moving into the first-line setting? Thank you. Thane Wettig: Sure thing. Thanks, Jay. Good to hear from you. Carol, you want to take that one, then I'll add on? Carol Gaddum: Sure. Yeah. I think these are exactly the type of questions we're looking to address with the phase II, and that's why we're allowing prior Lutetium-177 to understand how responses are similar or different in different patient subpopulations. To the prior question, we're also doing the scans to really understand where the patients fall and where there's the greatest unmet need and where we have the most compelling value proposition for FG-3180. I think all strategic options are here on the table, and it ultimately will be data-driven. Then to your point around moving up lines, I think that's what we've traditionally seen, right? Is from the post-chemo setting into the pre-chemo setting into the hormone-sensitive setting. So those are certainly part of our life cycle considerations moving forward. Thane, back to you. Thane Wettig: Yeah. Thanks, Carol. Jay, maybe one other comment, and this just comes from discussions with clinicians in this space. This isn't based upon dozens of interviews like we would do as we would contemplate a phase III design. But in speaking with some KOLs, they believe that a PSMA approach will continue to be kind of standard of care in this pre-chemo setting. What they also talk about is with the ARPIs, they're being used more in the castration-sensitive phase, and that clinicians are shying away from this ARPI switch approach just because you only get an incremental 4-6 months of additional rPFS when you switch from one ARPI to another. So they think that the PSMA approach, like Pluvicto or other PSMA-directed therapies, would be standard of care once a patient has progressed on an ARPI. Once a patient then progresses on a PSMA-directed therapy, they tend to think about a different target, but they also tend to think about a different modality. So if they were on an RLT that targeted PSMA, they then might think about an ADC that targets a different epitope, like CD46. So they wouldn't go from an RLT that targets PSMA to an ADC that targets PSMA. They also may not go from an RLT that targets PSMA to an RLT that targets another epitope. Again, it's more anecdotal than anything. We'll continue to, as Carol said, explore it. It'll be heavily driven by what we see in our phase II trial. But yeah, it's something that we think about a lot as we contemplate what a phase III design could look like. Jay Olson: Great. Thanks for taking the questions. Thane Wettig: You bet. Operator: I'd now like to turn the call back to Thane for closing remarks. Thane Wettig: Yeah, we appreciate everybody joining us for today's second quarter earnings call and your continued interest in Kyntra Bio. Enjoy the rest of your day, guys. Operator: This concludes today's conference call. Thank you for participating. You may now disconnect. Before you buy stock in Kyntra Bio, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Kyntra Bio wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $432,621!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,335,314!* That performance is why people listen. With a track record of beating the S&P 500 by nearly 5x, Stock Advisor offers a distinct advantage. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built for the long haul. See the 10 stocks » *Stock Advisor returns as of August 20, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Kyntra Bio (KYNB) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool

This article first appeared on GuruFocus. Revenue: Total revenue was negative $1.5 million for Q2 2026, compared to $1.3 million in Q2 2025. Total Operating Costs and Expenses: $16.1 million for Q2 2026, up from $13.4 million in Q2 2025. R&D Expenses: $6.8 million for Q2 2026, compared to $5.9 million in Q2 2025. SG&A Expenses: $9.3 million for Q2 2026, compared to $7.1 million in Q2 2025. Net Income (Loss): Net income from continuing operations was $12.0 million, or $2.96 per basic and diluted share, versus a net loss of $13.7 million, or $3.38 per share, in Q2 2025. Cash Position: Cash, equivalents, investments, and accounts receivable totaled $95.7 million as of June 30, 2026, with a projected cash runway into 2028. Warning! GuruFocus has detected 9 Warning Signs with KYNB. Is KYNB fairly valued? Test your thesis with our free DCF calculator. Release Date: August 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. FG-3246 Phase 2 interim analysis on track for Q4 2026, with potential to improve upon the 8.7-month median rPFS seen in Phase 1. FG-3246 demonstrated encouraging efficacy in heavily pre-treated mCRPC patients, including a 36% PSA50 response and 20% ORR with durable responses. Companion diagnostic FG-3180 shows early correlation between CD46 expression and response, supporting a biomarker-driven strategy. Roxadustat Phase 3 protocol finalized with FDA, targeting initiation in Q4 2026, and showing transfusion independence rates comparable to approved therapies. Cash runway into 2028 provides financial stability to advance key clinical milestones. Roxadustat has potential in RS-negative patients, a segment with high unmet need where current therapies are limited. Total revenue was negative $1.5 million in Q2 2026, a decline from $1.3 million in the prior year. Operating expenses increased to $16.1 million in Q2 2026 from $13.4 million in Q2 2025, driven by higher R&D and SG&A costs. Phase 3 roxadustat initiation is contingent on securing additional capital or a strategic partner, creating uncertainty. FG-3246 Phase 2 interim analysis may not meet futility criteria, and mature rPFS data will not be available until 2027. The company faces competitive pressure from PSMA-directed therapies like Pluvicto, which may limit FG-3246's market share. Potential economic dilution if partnering roxadustat, as AstraZeneca would receive 35% of any economics from a partnership. Q: How is the dosing regimen for the upcoming Phase 3 trial of roxadustat determined, and what is the titration interval?A: Carol Gaddum, VP of Product Development, explained that dose adjustments (up or down) are based on an assessment of benefit and risk, with changes possible every six weeks. Thane Wettig, CEO, added that specific guidance to sites will be based on factors including hemoglobin level and the rate of rise of that hemoglobin level. Q: How contingent is starting the Phase 3 trial for roxadustat on finding a partner, and how has the MATTERHORN data influenced the partnering calculus?A: Thane Wettig, CEO, stated the company is running a parallel path, evaluating both internal development (which would require raising capital) and strategic partnerships. He noted a key economic dynamic: if Kyntra develops and commercializes roxadustat itself, it owes AstraZeneca a mid-single-digit royalty on net sales; if a partner develops it, AZ is entitled to 35% of Kyntra's economics. The decision will be made in the best interest of shareholders. Q: Did the RS-positive/RS-negative data influence the potential Phase 3 design for roxadustat?A: Thane Wettig, CEO, confirmed that the RS-negative opportunity is a significant driver, as luspatercept has not shown a benefit in that population and is not indicated in the second-line setting for RS-negative patients. Carol Gaddum, VP of Product Development, added that the Phase 3 design was significantly informed by MATTERHORN, isolating transfusion burden as a key variable and ensuring enrollment of both RS-positive and RS-negative patients to demonstrate efficacy across both populations. Q: What is the anticipated enrollment of patients previously treated with Lutetium-177 (Pluvicto) in the FG-3246 Phase 2 trial, and could this lead to an accelerated approval strategy?A: Thane Wettig, CEO, revealed that approximately 30% of patients enrolled so far were previously treated with Pluvicto. The trial has a pre-specified analysis based on prior Pluvicto exposure to determine any differential impact. While not currently planning for accelerated approval, the company will be data-driven based on Phase 2 outcomes. Carol Gaddum, VP of Product Development, noted they are closely monitoring market dynamics to inform the design of a potential global Phase 3 trial. Q: Is it possible to obtain pre- and post-treatment biopsies to correlate PSMA expression levels with response to FG-3246?A: Carol Gaddum, VP of Product Development, stated the company is collecting tissue, PSMA scans, PET scans, and FG-3180 scans on a best-effort basis to understand how the disease evolves. She acknowledged limitations due to patient burden and the fact that mCRPC is often bone-only disease, making tissue availability challenging. The company is also incorporating ctDNA analysis, which showed a nice effect in the Phase 1 monotherapy trial. Q: How is Kyntra positioning FG-3246 as a differentiated non-PSMA approach, and is the greatest opportunity in PSMA-low/negative patients or as complementary to PSMA-directed therapies?A: Carol Gaddum, VP of Product Development, said these are exactly the questions the Phase 2 trial is designed to answer, with all strategic options on the table. Thane Wettig, CEO, added anecdotal insights from KOLs suggesting that after progression on a PSMA-directed therapy like Pluvicto, clinicians would likely switch to a different target and modality, such as an ADC targeting CD46, rather than another PSMA-targeted agent. Q: From a longer-term perspective, how is Kyntra thinking about moving roxadustat into the first-line setting?A: Carol Gaddum, VP of Product Development, indicated that moving into earlier lines of therapy is a traditional life-cycle management strategy, noting the progression from post-chemo to pre-chemo to hormone-sensitive settings. These are part of the company's life-cycle considerations moving forward. Q: Can you provide an update on the financial results for the second quarter of 2026?A: David DeLucia, CFO, reported total revenue of negative $1.5 million, total operating costs of $16.1 million, R&D expenses of $6.8 million, and SG&A expenses of $9.3 million. The company recorded a net income from continuing operations of $12 million, or $2.96 per share, compared to a net loss of $13.7 million in the prior year. Cash, equivalents, investments, and accounts receivable totaled $95.7 million as of June 30, 2026, providing a cash runway into 2028. For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Phase 2 monotherapy trial of FG-3246, a potential first-in-class antibody drug conjugate (ADC) targeting CD46 in metastatic castration-resistant prostate cancer (mCRPC), continues enrolling with interim analysis on track for 4Q 2026 Phase 3 protocol of roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (LR-MDS) and high transfusion burden (HTB) has been finalized with the goal to initiate the registrational study in 4Q 2026 Additional data from the Phase 3 MATTERHORN study were presented at the European Hematology Association (EHA) Congress 2026, highlighting improvements in transfusion independence in patients with HTB and regardless of ring sideroblast status Cash, cash equivalents, investments, and accounts receivable of $95.7 million as of June 30, 2026 Kyntra Bio to host conference call and webcast presentation today at 5:00 PM ET SAN FRANCISCO, Aug. 13, 2026 (GLOBE NEWSWIRE) -- Kyntra Bio (Nasdaq: KYNB) today reported financial results for the second quarter 2026 and provided an update on the company’s recent developments. “We continue to make progress across our oncology and rare disease portfolio and remain laser-focused on advancing toward our goal of initiating a pivotal Phase 3 trial of roxadustat in LR-MDS in the fourth quarter of this year and conducting an interim analysis of the Phase 2 trial of FG-3246 in mCRPC, also in the fourth quarter of this year,” said Thane Wettig, Chief Executive Officer of Kyntra Bio. “We believe we have the substrate that will enable us to create significant value for patients and stakeholders as we advance our pipeline and look forward to providing additional updates in the coming months.” Key Highlights of Second Quarter, Recent Developments, and Upcoming Milestones FG-3246 (CD46 Targeting ADC) and FG-3180 (CD46 Targeting PET Imaging Agent) Enrollment in the Phase 2 monotherapy trial of FG-3246, a potential first-in-class ADC targeting CD46 in mCRPC continues; interim analysis is on track for the fourth quarter of 2026. Roxadustat Pivotal Phase 3 trial protocol of roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden (HTB) has been finalized. Additional data from the Phase 3 MATTERHORN study were presented at the European Hematology Association (EHA) Congress 2026. Company continues to explore the opportunity to develop roxadustat internally or with a strategic partner, with the goal of initiating the Phase 3 trial in the fourth quarter of 2026. Financial Total revenue from continuing operations for the second quarter of 2026 was $(1.5) million, as compared to $1.3 million for the second quarter of 2025. Net income from continuing operations for the second quarter of 2026 was $12.0 million, or $2.96 net income per basic and diluted share, compared to a net loss of $13.7 million, or $3.38 net loss per basic and diluted share, one year ago. As of June 30, 2026, Kyntra Bio reported $95.7 million in cash, cash equivalents, investments, and accounts receivable. The Company expects its cash, cash equivalents, investments, and accounts receivable to be sufficient to fund operating plans into 2028. Conference Call and Webcast PresentationKyntra Bio management team will host a conference call and webcast presentation to discuss the financial results and provide a business update. A live Q&A session will follow the brief presentation. Interested parties may access a live audio webcast of the conference call here. To access the call by phone, please register here, and you will be provided with dial in details. A replay of the webcast will also be available for a limited time on the Events & Presentations page on Kyntra Bio’s website. About FG-3246 and FG-3180FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by Kyntra Bio for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies. FG-3180 is a companion diagnostic PET imaging agent, using the same CD46-targeting antibody together with an 89Zr tracer. To date, FG-3180 demonstrated specific uptake in CD46 positive tumors and is currently being evaluated as a biomarker for its potential to inform patient selection. About RoxadustatRoxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is approved in Europe, Japan, China, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Kyntra Bio has the sole rights to roxadustat in the United States, Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas. Astellas and Kyntra Bio are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa. About Kyntra BioKyntra Bio is a biopharmaceutical company focused on development of novel therapies in oncology and rare disease. Roxadustat (爱瑞卓®, EVRENZO™) is currently approved in Europe, Japan, China, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The Company continues to evaluate the development plan for the Phase 3 trial of roxadustat in anemia associated with lower-risk myelodysplastic syndromes (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46, is in Phase 2 development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker. For more information, please visit www.kyntrabio.com. Forward-Looking Statements This release contains forward-looking statements regarding Kyntra Bio’s strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of its partners Fortis and UCSF. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential clinical or commercial success of Kyntra Bio products and product candidates, statements under the caption “Recent Highlights and Upcoming Milestones”, statements about regulatory interactions, statements regarding cash, such as the expectation that cash, cash equivalents and accounts receivable will be sufficient to fund Kyntra Bio’s operating plans into 2028, and statements about Kyntra Bio’s plans and objectives. These forward-looking statements are typically identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. Kyntra Bio’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in Kyntra Bio’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, each as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Kyntra Bio undertakes no obligation to update any forward-looking statement in this press release, except as required by law. Condensed Consolidated Balance Sheets(In thousands) (1) The condensed consolidated balance sheet amounts at December 31, 2025 are derived from audited financial statements. Condensed Consolidated Statements of Operations(In thousands, except per share data) For Investor Inquiries:David DeLucia, CFASenior Vice President and Chief Financial [email protected]

Kamada (KMDA) came out with quarterly earnings of $0.16 per share, beating the Zacks Consensus Estimate of $0.12 per share. This compares to earnings of $0.13 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +33.33%. A quarter ago, it was expected that this biopharmaceutical would post earnings of $0.12 per share when it actually produced earnings of $0.07, delivering a surprise of -41.67%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. Kamada, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $54.92 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 6.39%. This compares to year-ago revenues of $44.75 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Kamada shares have added about 0.4% since the beginning of the year versus the S&P 500's gain of 12.9%. While Kamada has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Kamada was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.13 on $54.79 million in revenues for the coming quarter and $0.44 on $202.89 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 38% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Another stock from the same industry, Kyntra Bio (KYNB), has yet to report results for the quarter ended June 2026. The results are expected to be released on August 13. This biotech drug developer is expected to post quarterly loss of $3.18 per share in its upcoming report, which represents a year-over-year change of +5.9%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Kyntra Bio's revenues are expected to be $1.99 million, up 47.6% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Kamada Ltd. (KMDA) : Free Stock Analysis Report Kyntra Bio Inc (KYNB) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

The market expects Kyntra Bio (KYNB) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This biotech drug developer is expected to post quarterly loss of $3.18 per share in its upcoming report, which represents a year-over-year change of +5.9%. Revenues are expected to be $1.99 million, up 47.4% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 1.62% higher over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. This insight is at the core of our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction). The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Kyntra Bio, the Most Accurate Estimate is higher than the Zacks Consensus Estimate, suggesting that analysts have recently become bullish on the company's earnings prospects. This has resulted in an Earnings ESP of +5.44%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination indicates that Kyntra Bio will most likely beat the consensus EPS estimate. Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Kyntra Bio would post a loss of$3.36 per share when it actually produced a loss of -$3.74, delivering a surprise of -11.31%. Over the last four quarters, the company has beaten consensus EPS estimates two times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Kyntra Bio appears a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Among the stocks in the Zacks Medical - Biomedical and Genetics industry, Cytek Biosciences, Inc. (CTKB), is soon expected to post loss of $0.02 per share for the quarter ended June 2026. This estimate indicates a year-over-year change of -300%. This quarter's revenue is expected to be $47.36 million, up 3.9% from the year-ago quarter. The consensus EPS estimate for Cytek Biosciences has been revised 50% higher over the last 30 days to the current level. However, an equal Most Accurate Estimate has resulted in an Earnings ESP of 0.00%. This Earnings ESP, combined with its Zacks Rank #2 (Buy), makes it difficult to conclusively predict that Cytek Biosciences will beat the consensus EPS estimate. Over the last four quarters, the company surpassed EPS estimates just once. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Kyntra Bio Inc (KYNB) : Free Stock Analysis Report Cytek Biosciences, Inc. (CTKB) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Vericel Corporation (VCEL) came out with quarterly earnings of $0.04 per share, beating the Zacks Consensus Estimate of a loss of $0.04 per share. This compares to a loss of $0.01 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +200.00%. A quarter ago, it was expected that this company would post a loss of $0.15 per share when it actually produced a loss of $0.12, delivering a surprise of +20%. Over the last four quarters, the company has surpassed consensus EPS estimates three times. Vericel, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $77.46 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 7.58%. This compares to year-ago revenues of $63.24 million. The company has topped consensus revenue estimates four times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Vericel shares have added about 29.5% since the beginning of the year versus the S&P 500's gain of 6.9%. While Vericel has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Vericel was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is $0.12 on $83.5 million in revenues for the coming quarter and $0.49 on $330.9 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the top 37% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. Kyntra Bio (KYNB), another stock in the same industry, has yet to report results for the quarter ended June 2026. This biotech drug developer is expected to post quarterly loss of $3.18 per share in its upcoming report, which represents a year-over-year change of +5.9%. The consensus EPS estimate for the quarter has been revised 1.6% higher over the last 30 days to the current level. Kyntra Bio's revenues are expected to be $1.99 million, up 47.6% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Vericel Corporation (VCEL) : Free Stock Analysis Report Kyntra Bio Inc (KYNB) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Image source: The Motley Fool. May 11, 2026 Chief Executive Officer — Thane Wettig Chief Financial Officer — David DeLucia Vice President, Product Development — Carol Gaddum Need a quote from a Motley Fool analyst? Email [email protected] 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. Before you buy stock in Kyntra Bio, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Kyntra Bio wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $471,827!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,319,291!* Now, it’s worth noting Stock Advisor’s total average return is 986% — a market-crushing outperformance compared to 207% for the S&P 500. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built by individual investors for individual investors. See the 10 stocks » *Stock Advisor returns as of May 11, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Kyntra Bio (KYNB) Q1 2026 Earnings Transcript was originally published by The Motley Fool

Phase 2 monotherapy trial of FG-3246, a potential first-in-class antibody drug conjugate (ADC) targeting CD46, in metastatic castration-resistant prostate cancer (mCRPC) is progressing well with the interim analysis anticipated in 4Q 2026 Positive results from the investigator-sponsored study of FG-3246 in combination with enzalutamide in patients with mCRPC were presented at ASCO GU in February 2026, further validating key Phase 2 monotherapy design elements Pivotal Phase 3 trial protocol of roxadustat for the treatment of anemia in patients with lower-risk myelodysplastic syndromes (LR-MDS) and high transfusion burden is being finalized following feedback from the U.S. Food and Drug Administration (FDA) Cash, cash equivalents, investments, and accounts receivable of $100.3 million, providing cash runway into 2028 Kyntra Bio to host conference call and webcast presentation today at 5:00 PM ET SAN FRANCISCO, May 11, 2026 (GLOBE NEWSWIRE) -- Kyntra Bio (Nasdaq: KYNB) today reported financial results for the first quarter 2026 and provided an update on the company’s recent developments. “In the first quarter, we continued to make steady progress across our pipeline. We are encouraged by the pace of enrollment in our Phase 2 trial of FG-3246 in patients with mCRPC and are on track for the interim analysis in the fourth quarter of 2026. We remain confident in the potential of FG-3246 to deliver competitive progression free survival results in the Phase 2 monotherapy trial,” commented Thane Wettig, Chief Executive Officer of Kyntra Bio. “In addition, following FDA feedback, we are finalizing the protocol for the pivotal Phase 3 trial of roxadustat for the treatment of lower-risk MDS, and anticipate trial initiation in the second half of 2026.” Key Highlights of First Quarter, Recent Developments, and Upcoming Milestones FG-3246 (CD46 Targeting ADC) and FG-3180 (CD46 Targeting PET Imaging Agent) Phase 2 monotherapy trial of FG-3246, a potential first-in-class ADC targeting CD46, in mCRPC is actively enrolling and remains on track for interim analysis in the fourth quarter of 2026 Topline results from the investigator-sponsored Phase 1b/2 study, conducted by UCSF, of FG-3246 in combination with enzalutamide in patients with mCRPC were presented at ASCO GU 2026 In biomarker unselected patients with androgen receptor pathway inhibitor (ARPI)-treated, taxane-naïve mCRPC, the combination of FG-3246 and enzalutamide led to a median radiographic progression free survival (rPFS) of 7.0 months in the overall study cohort, and a median rPFS of 10.1 months in patients who progressed on only one prior ARPI. Higher tumor uptake of FG-3180 was numerically associated with PSA50 response (nominal p=0.053), highlighting its potential as a biomarker for patient selection. Combination therapy had a similar safety and exposure profile to the previous FG-3246 Phase 1 monotherapy trial. Results further validate key FG-3246 Phase 2 monotherapy design elements, most importantly the inclusion of patients who have progressed on only one prior ARPI and integration of baseline FG-3180 PET for all enrolled patients. Roxadustat Pivotal Phase 3 trial protocol of roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden is being finalized based on feedback received from the FDA Company continues to explore the opportunity to develop roxadustat internally or with a strategic partner, with the goal of initiating the Phase 3 trial in the second half of 2026 Financial Total revenue from continuing operations for the first quarter of 2026 was $3.7 million, as compared to $2.7 million for the first quarter of 2025. Net loss from continuing operations for the first quarter of 2026 was $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. As of March 31, 2026, Kyntra Bio reported $100.3 million in cash, cash equivalents, investments, and accounts receivable. The Company expects its cash, cash equivalents, investments, and accounts receivable to be sufficient to fund operating plans into 2028. Conference Call and Webcast Presentation Kyntra Bio management team will host a conference call and webcast presentation to discuss the financial results and provide a business update. A live Q&A session will follow the brief presentation. Interested parties may access a live audio webcast of the conference call here. To access the call by phone, please register here, and you will be provided with dial in details. A replay of the webcast will also be available for a limited time on the Events & Presentations page on Kyntra Bio’s website. About FG-3246 and FG-3180 FG-3246 (FOR46) is a potential first-in-class fully human antibody-drug conjugate (ADC), exclusively in-licensed from Fortis Therapeutics, and is being developed by Kyntra Bio for metastatic castration-resistant prostate cancer and potentially other tumor types. FG-3246 binds to an epitope of CD46, a cell receptor target, that induces internalization upon antibody binding, is present at high levels in prostate cancer and other tumor types and demonstrates very limited expression in most normal tissues. FG-3246 is comprised of an anti-CD46 antibody, YS5, linked to the anti-mitotic agent, MMAE, which is a clinically and commercially validated ADC payload. FG-3246 has demonstrated anti-tumor activity in both preclinical and clinical studies. FG-3180 is a companion diagnostic PET imaging agent, using the same CD46-targeting antibody together with an 89Zr tracer. To date, FG-3180 demonstrated specific uptake in CD46 positive tumors and is currently being evaluated as a biomarker for its potential to inform patient selection. About Roxadustat Roxadustat, an oral medication, is the first in a new class of medicines comprising HIF-PH inhibitors that promote erythropoiesis, or red blood cell production, through increased endogenous production of erythropoietin, improved iron absorption and mobilization, and downregulation of hepcidin. Roxadustat is approved in Europe, Japan, China, and numerous other countries for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Kyntra Bio has the sole rights to roxadustat in the United States, Canada, Mexico, and in all markets not held by AstraZeneca or licensed to Astellas. Astellas and Kyntra Bio are collaborating on the commercialization of roxadustat for the treatment of anemia in territories including Japan, Europe, Turkey, Russia, and the Commonwealth of Independent States, the Middle East, and South Africa. About Kyntra Bio Kyntra Bio is a biopharmaceutical company focused on development of novel therapies in oncology and rare disease. Roxadustat (爱瑞卓®, EVRENZO™) is currently approved in Europe, Japan, China, and numerous other countries for the treatment of anemia in chronic kidney disease (CKD) patients on dialysis and not on dialysis. The Company continues to evaluate the development plan for the Phase 3 trial of roxadustat in anemia associated with lower-risk myelodysplastic syndromes (LR-MDS) in the U.S. FG-3246 (also known as FOR46), a first-in-class antibody-drug conjugate (ADC) targeting CD46, is in Phase 2 development for the treatment of metastatic castration-resistant prostate cancer. This program also includes the development of FG-3180, an associated CD46-targeted PET biomarker. For more information, please visit www.kyntrabio.com. Forward-Looking Statements This release contains forward-looking statements regarding Kyntra Bio’s strategy, future plans and prospects, including statements regarding its commercial products and clinical programs and those of its partners Fortis and UCSF. These forward-looking statements include, but are not limited to, statements regarding the efficacy, safety, and potential clinical or commercial success of Kyntra Bio products and product candidates, statements under the caption “Recent Highlights and Upcoming Milestones”, statements about regulatory interactions, statements regarding cash, such as the expectation that cash, cash equivalents and accounts receivable will be sufficient to fund Kyntra Bio’s operating plans into 2028, and statements about Kyntra Bio’s plans and objectives. These forward-looking statements are typically identified by use of terms such as “may,” “will”, “should,” “on track,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “continue” and similar words, although some forward-looking statements are expressed differently. Kyntra Bio’s actual results may differ materially from those indicated in these forward-looking statements due to risks and uncertainties related to the continued progress and timing of its various programs, including the enrollment and results from ongoing and potential future clinical trials, and other matters that are described in Kyntra Bio’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q, each as filed with the Securities and Exchange Commission (SEC), including the risk factors set forth therein. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release, and Kyntra Bio undertakes no obligation to update any forward-looking statement in this press release, except as required by law. For Investor Inquiries: David DeLucia, CFA Senior Vice President and Chief Financial Officer [email protected]

This article first appeared on GuruFocus. Total Revenue: $3.7 million for Q1 2026, up from $2.7 million in Q1 2025. Total Operating Costs and Expenses: $17.6 million for Q1 2026, compared to $17.7 million in Q1 2025. R&D Expenses: $7.6 million for Q1 2026, down from $9.2 million in Q1 2025. SG&A Expenses: $5.9 million for Q1 2026, down from $8.1 million in Q1 2025. Net Loss: $15.1 million for Q1 2026, or $3.74 per share, compared to $16.8 million, or $4.15 per share, in Q1 2025. Cash Equivalents, Investments, and Accounts Receivable: $100.3 million as of March 31, 2026. Cash Runway: Expected to extend into 2028. Warning! GuruFocus has detected 8 Warning Signs with KYNB. Is KYNB fairly valued? Test your thesis with our free DCF calculator. Release Date: May 11, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Kyntra Bio Inc (NASDAQ:KYNB) is actively enrolling patients in a Phase 2 monotherapy trial for FG-3246 in metastatic castration-resistant prostate cancer, with an anticipated interim analysis in Q4 2026. The company has a cash runway into 2028, providing financial stability to continue investing in its pipeline. Roxadustat has received orphan drug designation for lower-risk myelodysplastic syndromes, with a Phase 3 trial expected to initiate in the second half of 2026. Kyntra Bio Inc (NASDAQ:KYNB) reported an increase in total revenue to $3.7 million for Q1 2026, compared to $2.7 million in the same period of 2025. The company has reduced R&D and SG&A expenses compared to the previous year, indicating improved cost management. Kyntra Bio Inc (NASDAQ:KYNB) reported a net loss of $15.1 million for Q1 2026, although this is an improvement from the previous year's loss. The company is not disclosing enrollment figures for its ongoing trials, which may concern investors seeking transparency. FG-3246's Phase 1 trial showed a median RPFS of 8.7 months, which the company aims to improve upon, indicating current results may not yet meet commercial competitiveness benchmarks. The company faces risks related to the development and regulatory approval of its clinical programs, as highlighted in their forward-looking statements. Kyntra Bio Inc (NASDAQ:KYNB) is still in the process of finalizing the Phase 3 protocol for roxadustat, indicating potential delays in trial initiation. Q: What are the key metrics you are looking for in the Phase 2 trial of FG-3180 to decide its use in Phase 3? A: Thane Wettig, CEO, explained that they are looking at typical measures such as PSA50, ORR, duration of response, dose response, and PK parameters. The decision to continue with all three doses or adjust will be based on these metrics. They aim to see a statistically significant p-value to confirm the correlation between CD46 expression and response to the ADC. Q: What role could FG-3180 serve in Phase 3 if not used for patient enrollment based on uptake? A: Thane Wettig, CEO, stated that if a correlation between CD46 expression and ADC response is observed, FG-3180 could be used for patient selection in Phase 3. If no correlation is found, they would still collect expression data to inform the characterization of the target in a larger Phase 3 trial. Q: Has there been any change in interest or feedback regarding FG-3180 since presenting the IST data? A: Thane Wettig, CEO, noted that while he can't comment on specific business development activities, the data showing the association between CD46 expression and ADC response has been intriguing for both Kyntra Bio and others. Carol Gaddum, VP of Product Development, added that there has been encouraging interaction with investigators and excitement reflected in current enrollment activities. Q: When can more details about the roxadustat Phase 3 trial be expected? A: Thane Wettig, CEO, mentioned that they are close to finalizing the Phase 3 protocol and have selected a CRO for the trial. They will keep the investment community updated but won't comment further on the protocol specifics at this time. Q: What are the expectations for the interim analysis of the Phase 2 trial in the fourth quarter? A: Thane Wettig, CEO, stated that they expect to see results consistent with the composite response of ORR and PSA50 from the Phase 1 trial. The interim analysis will inform whether to continue with all doses or adjust based on efficacy and safety results. For the complete transcript of the earnings call, please refer to the full earnings call transcript.