Q4 2025 FibroGen Inc Earnings Call

March 16, 2026

Speaker #1: Call. At this time, all participants are in a listen-only mode. After the speaker presentation, there will be a question-and-answer session. To ask a question during the session, you will need to press star 11 on your telephone.

Speaker #3: statistically

Speaker #3: significant. This data demonstrates for the first

Speaker #2: Thank you for standing by and welcome to Kintra Bio's fourth quarter and full year 2025 earnings conference call. At this time, all participants are in a listen-only mode.

Speaker #3: time an association

Speaker #3: between CD46 expression

Speaker #3: and response to

Speaker #3: FG3246. Further evaluation

Speaker #3: FG3180 is an important part

Speaker #1: To remove yourself from the queue, you may press star 11 again. I would now like to hand the call over to Gaia Shamus with LifeSci Advisors.

Speaker #3: of the ongoing phase two

Speaker #2: After the speaker presentation, there will be a question-and-answer session. To ask a question during the session, you will need to

Speaker #3: monotherapy

Speaker #3: trial. Finally, on slide 11, the combination

Speaker #3: of FG3246 and

Speaker #1: Please go ahead.

Speaker #3: Enzalutamide had a similar safety profile to what

Speaker #2: press star 11 on your

Speaker #2: Thank you, Operator. Good afternoon, everyone. Thank you for joining today to discuss Kyntra Bio's fourth quarter and full year 2025 financial and business results.

Speaker #2: telephone. To remove yourself from the queue,

Speaker #3: was observed in the

Speaker #3: FG3246 phase one

Speaker #2: you may press star 11 again. I would now like to hand the call over

Speaker #3: monotherapy trial. Importantly, the incidence of grade 3 or greater neutropenia was substantially reduced with the.

Speaker #2: to Gaia Sheamus with

Speaker #2: LifePsy Advisors.

Speaker #2: Please go ahead.

Speaker #2: I'm Gaia Shamus 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.

Speaker #3: Thank

Speaker #3: you, Operator. Good

Speaker #3: Good afternoon, everyone. Thank you for joining.

Speaker #3: Today, to discuss Kintra Bio's fourth—

Speaker #3: quarter and full year

Speaker #3: 2025 financial and business

Speaker #3: results. I'm Gaia Sheamus from

Speaker #3: LifePsy Advisors. Joining me on

Speaker #2: 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.

Speaker #3: Chief Executive Officer;

Speaker #3: David DeLucia, Chief Financial

Speaker #3: Officer; and Carol Geddum, Vice

Speaker #3: President of Product

Speaker #3: Development. Following the prepared remarks, we will

Speaker #3: open the call to your questions. I

Speaker #3: I would like to remind you that remarks

Speaker #3: made on today's call include

Speaker #3: forward-looking statements about Kintra

Speaker #3: Bio, such statements may include

Speaker #3: but are not limited to

Speaker #3: collaborations with AstraZeneca and

Speaker #3: Astellas, financial

Speaker #3: guidance, the initiation/enrollment

Speaker #3: design, conduct, and results of

Speaker #3: clinical trials, regulatory

Speaker #2: 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.

Speaker #3: strategies and potential

Speaker #3: regulatory results, research and

Speaker #3: development activities, commercial

Speaker #3: results and results of

Speaker #3: operations, risks related to our business,

Speaker #2: 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.

Speaker #3: and certain other business

Speaker #3: matters. Each forward-looking statement

Speaker #3: is subject to risks and

Speaker #3: uncertainties that could cause actual results and

Speaker #3: events to differ materially from

Speaker #3: those projected in that

Speaker #3: statement. A more complete description of these

Speaker #2: 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 Investors section of Kyntra Bio website, at www.kyntra-bio.com.

Speaker #3: and other material risks can be found

Speaker #3: in Kintra Bio's filing with the

Speaker #3: SEC, including our most

Speaker #3: recent Form 10-K and Form

Speaker #3: 10-Q. Kintra

Speaker #3: Bio does not undertake any obligation

Speaker #3: to update publicly

Speaker #3: any forward-looking statements, whether as a result

Speaker #3: of new information, future events,

Speaker #3: release reporting the company's financial

Speaker #2: With that, I would like to turn the call over to the CEO, Thane Wettig. Thane?

Speaker #3: results and business updates and

Speaker #3: A webcast of today's conference call

Speaker #3: can be found on the investor section

Speaker #3: Thank you, Gaia. Good afternoon, everyone, and welcome to our fourth quarter and full year 2025 earnings call. On today's call, I will provide an update on the continued progress with FG3246, a potential first-in-class antibody-drug conjugate targeting CD46, and its companion PET imaging agent, and metastatic castration-resistant prostate cancer, as well as the path forward for Roxadustat as a potential treatment for anemia due to lower-risk modus plastic syndromes.

Speaker #3: of Kintra Bio website

Speaker #3: at

Speaker #3: www.kintrabio.com. With

Speaker #3: With that, I would like to turn the call over.

Speaker #3: over to the CEO, Thane

Speaker #3: Wettig. Thane?

Speaker #4: Thank you,

Speaker #4: Gaia. Good afternoon, everyone, and

Speaker #4: Welcome to our fourth quarter and full year.

Speaker #4: 2025 earnings

Speaker #4: On today's call, I will provide

Speaker #4: an update on the continued progress with

Speaker #4: FG3246, a

Speaker #4: potential first-in-class antibody-drug

Speaker #4: conjugate targeting

Speaker #4: CD46, and its companion PET imaging.

Speaker #3: Then David DeLucia, our CFO, will review the financials after which we will open the call for your questions. On slide 3, I'd like to start by highlighting the transformational year we had in 2025.

Speaker #4: agent in metastatic

Speaker #4: castration-resistant prostate cancer, as well as the

Speaker #4: path forward for Roxadustat as a potential

Speaker #4: treatment for anemia due to

Speaker #4: lower-risk modus plastic

Speaker #4: syndromes. Then David DeLucia, our

Speaker #3: We completed the sale of Fibrogen China to AstraZeneca, paid off our senior secure term loan, and extended our cash runway into 2028. This enabled us to start the phase two trial for FG3246 and FG3180 in the post-ARPI pre-chemo setting in metastatic castration-resistant prostate cancer, where we are actively enrolling patients at multiple sites in the US.

Speaker #4: CFO, will review the financials

Speaker #4: after which we will open the call for your questions. On slide three,

Speaker #4: I'd like to start by highlighting the

Speaker #4: transformational year we had in

Speaker #4: 2025. We completed the

Speaker #4: sale of Fibrogen China to

Speaker #4: AstraZeneca, paid off our senior secure

Speaker #4: term loan, and extended our cash

Speaker #4: runway into

Speaker #4: 2028. This enabled us to start the Phase 2 trial.

Speaker #4: for FG3246

Speaker #3: We recently reported the top-line results presented at ASCO GU from the investigator-sponsored trial of FG3246 in combination with Enzalutamide in MCRPC, and we remain on track to report the interim results from our ongoing phase two monotherapy trial of FG3246 and FG3180 in the second half of 2026.

Speaker #4: and FG3180 in the

Speaker #4: post-ARPI pre-chemo

Speaker #4: setting in metastatic

Speaker #4: Castration-resistant prostate cancer—where we are.

Speaker #4: actively enrolling patients at multiple

Speaker #4: sites in the US. We

Speaker #4: recently reported the top-line results presented

Speaker #4: at ASCO GU from the

Speaker #4: investigator-sponsored trial of

Speaker #4: FG3246 in

Speaker #4: combination with Enzalutamide in

Speaker #1: Handle the ROCTA tech question as well. First, in terms of the kind of ARPI efficacy, the balance of patients from the recently disclosed IST versus the ongoing Phase 2 monotherapy: there were about 60% of patients from the IST that had progressed on two or more ARPIs, and about 40% of patients who had progressed on only one ARPI.

Speaker #4: MCRPC, and we remain

Speaker #3: We also made important progress with Roxadustat, with the submission of the phase three protocol for lower-risk modus plastic syndromes and the receipt of orphan drug designation for MDS.

Speaker #4: on track to report the interim results

Speaker #4: from our ongoing phase two

Speaker #4: monotherapy trial of

Speaker #4: FG3246 and

Speaker #4: FG3180 in the second half of

Speaker #4: 2026. We also

Speaker #3: We expect feedback on the phase three trial design from the FDA in the coming weeks, with the aim of initiating the phase three trial in the second half of this year.

Speaker #4: made important progress with

Speaker #4: Roxadustat, with the submission of the phase three

Speaker #4: protocol for lower-risk modus plastic

Speaker #4: syndromes and the receipt of orphan

Speaker #3: We began 2026 rejuvenated, rebranding Fibrogen to Kyntra Bio to better reflect the momentum and energy of a company focused on oncology and rare disease.

Speaker #4: drug designation for

Speaker #4: MDS. We expect feedback on the

Speaker #1: In our Phase 2 monotherapy, patients will have only progressed on one prior ARPI and be in the pre-chemo setting. And so that's, I think, a pretty important differentiator.

Speaker #4: phase three trial design from the FDA in the

Speaker #4: coming weeks, with the aim of

Speaker #4: initiating the Phase Three trial in the second

Speaker #3: We remain confident that with our mid and late-stage assets, simplified capital structure, and upcoming catalysts across both clinical programs, we are well positioned to create meaningful therapeutic options for patients and significant value for shareholders.

Speaker #4: half of this year. We

Speaker #4: began 2026

Speaker #1: So, 100% of our patients in the Phase 2 monotherapy trial will have progressed on one prior ARPI, whereas in the IST, about 40% of patients had progressed on only one, and then 60% had progressed on two or more.

Speaker #4: rejuvenated, rebranding Fibrogen to

Speaker #4: Kintra Bio to better reflect the

Speaker #4: momentum and energy of a company focused on

Speaker #4: oncology and rare

Speaker #4: disease. We remain confident that with our

Speaker #4: mid and late-stage assets,

Speaker #4: simplified capital structure, and

Speaker #3: Moving to our FG3246 and FG3180 program in MCRPC, slide 5 summarizes the high unmet need in late-stage prostate cancer. Approximately 290,000 men are diagnosed with prostate cancer each year in the US, with about 65,000 drug-treatable patients with metastatic disease that has become castration-resistant.

Speaker #1: Carol, anything to add to that?

Speaker #4: upcoming catalysts across both clinical

Speaker #5: The only thing to add on here is that the setting that we're looking at is really that established by PSMA-4. So it's looking for efficacy benchmarks—that's really what we're targeting.

Speaker #4: programs, we are well positioned to

Speaker #4: create meaningful therapeutic options for

Speaker #4: patients and significant

Speaker #4: value for

Speaker #4: shareholders. Moving to our

Speaker #5: So, it's post one prior ARPI.

Speaker #4: FG3246 and FG3180

Speaker #4: program in

Speaker #4: MCRPC, slide five, summarizes the

Speaker #1: Okay. And then, Matt, as it relates to the ROCTA tech question, we're not going to comment on the specifics of where we are with respect to that effort. Where we say we're evaluating the opportunity to develop it internally versus potentially having some sort of a collaboration with a strategic, we're continuing to explore both paths, but we're not at a place right now where we can comment further on that.

Speaker #4: high unmet need in late-stage prostate

Speaker #4: cancer. Approximately

Speaker #3: This group of patients has a grim five-year survival rate of approximately 30%, underscoring the significant opportunity for a new life-extending treatments. We believe FG3246 could be this new treatment option and estimate the total addressable market to be well over $5 billion annually in the US alone.

Speaker #4: 290,000 men are diagnosed with

Speaker #4: prostate cancer each year in the

Speaker #4: US, with about 65,000

Speaker #4: drug-treatable patients with metastatic

Speaker #4: disease that has become

Speaker #4: castration-resistant. This group of patients

Speaker #4: has a grim five-year survival rate of

Speaker #4: approximately

Speaker #4: 30%, underscoring the significant

Speaker #4: opportunity for a new life-extending

Speaker #4: treatments. We believe

Speaker #3: Slide 6 depicts the novelty of CD46, a tumor-selective target that has several distinguishing features. First, CD46 is upregulated during tumorogenesis, and helps tumors evade complement-dependent cytotoxicity.

Speaker #6: Yep. No, makes sense. Thanks again, guys.

Speaker #4: FG3246 could be this new

Speaker #4: treatment option and estimate the

Speaker #1: Great, thank you, Matt. Appreciate the continued coverage.

Speaker #4: Total addressable market to be well

Speaker #4: over $5 billion annually in

Speaker #4: Thank you. Our next question comes from the line of Chen Lin of Lin Asset Management. Your line is open, Chen.

Speaker #4: the US

Speaker #4: alone. Slide six depicts the

Speaker #4: novelty of

Speaker #4: CD46, a tumor-selective target that has

Speaker #3: Second, its expression is also upregulated in the progression from localized castration-sensitive prostate cancer to metastatic castration-resistant prostate cancer. And further overexpressed following treatment with androgen signaling inhibitors.

Speaker #4: several distinguishing

Speaker #4: features. First, CD46 is

Speaker #7: All right. Thank you for taking my question. Thank you. Both my questions have already been answered. I'm just curious about ROCTA. The FDA is supposed to give feedback in 30 days.

Speaker #4: upregulated during

Speaker #4: tumorogenesis, and helps tumors evade

Speaker #4: complement-dependent

Speaker #4: cytotoxicity. Second, its expression is also

Speaker #4: upregulated in the progression from

Speaker #3: Notably, CD46 is highly expressed in MCRPC tissues, with lower interpatient variability and PSMA, making it an attractive non-PSMA therapeutic target. Turning to slide 7, FG3246 is our potential first-in-class ADC in development for MCRPC.

Speaker #4: localized castration-sensitive prostate

Speaker #4: cancer to metastatic

Speaker #7: Giving is often status, which is why there seems to be a delay in the acceptance of the IND.

Speaker #4: castration-resistant prostate

Speaker #4: cancer. And furthermore, expressed following treatment

Speaker #4: with androgen signaling

Speaker #4: inhibitors. Notably,

Speaker #4: CD46 is highly expressed in

Speaker #1: Yeah, thanks, Chen. When we submitted the protocol to the FDA right before Christmas, we let the FDA know that we were not going to be imminently starting the Phase 3 trial.

Speaker #4: MCRPC tissues, with

Speaker #4: higher median expression compared with

Speaker #4: PSMA, making it an

Speaker #3: The ADC combines the YS5 antibody with an MMAE payload to specifically target the tumor-selective epitope of CD46. Whose expression is limited in normal tissue.

Speaker #4: attractive non-PSMA therapeutic

Speaker #4: target. Turning to

Speaker #1: And so what would typically happen is, when a company is fully geared up to start the Phase 3 and they submit the final protocol, the FDA typically gets back within 30 days.

Speaker #4: slide seven,

Speaker #4: FG3246 is our potential

Speaker #4: first-in-class ADC in development for

Speaker #4: MCRPC. The

Speaker #3: FG3246 represents an androgen receptor-agnostic approach clinically differentiating it from other prostate cancer treatments currently in development, many of which target PSMA. The companion PET imaging agent, FG3180, utilizes the same YS5 targeting antibody as FG3246 and is also under clinical development with its own IND.

Speaker #4: ADC combines the YS5

Speaker #4: antibody with an MMAE payload

Speaker #1: The FDA knew that they had a little bit more time. And so what they had signaled to us was 60 to 90 days. And we're right in that 60- to 90-day period right now.

Speaker #4: to specifically target the

Speaker #4: tumor-selective epitope of

Speaker #4: CD46, whose expression is limited in

Speaker #4: normal tissue.

Speaker #4: FG3246 represents an androgen

Speaker #1: And so, when we say that we expect feedback in the coming weeks, that's based upon the guidance that had been provided from the FDA when we had submitted the protocol right before the holidays.

Speaker #4: receptor-agnostic approach

Speaker #4: clinically differentiating it from other

Speaker #4: prostate cancer treatments currently in

Speaker #4: development, many of which target

Speaker #4: PSMA. The companion

Speaker #3: We believe that having a patient-selection biomarker would not only allow us to better enrich the patient population in a future phase three trial, it could also enable differentiation of FG3246 in the prostate cancer treatment paradigm.

Speaker #4: PET imaging agent,

Speaker #4: FG3180, utilizes the same YS5

Speaker #7: Okay, great. Thank you. Good luck.

Speaker #4: targeting antibody as

Speaker #4: FG3246 and is also

Speaker #1: No, thanks, Chen. Appreciate the support.

Speaker #4: under clinical development with its own

Speaker #4: IND. We believe that

Speaker #4: Thank you. I would now like to turn the conference back to Thane Wettig for closing remarks. Sir?

Speaker #4: having a patient-selection biomarker

Speaker #3: 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.

Speaker #4: would not only allow us to better enrich the

Speaker #4: patient population in a future

Speaker #1: Yeah, no, thank you. And thank you for joining us for today's fourth quarter and full-year earnings call. We appreciate your interest in Kyntra Bio.

Speaker #4: phase three trial, it could also

Speaker #4: enable differentiation of

Speaker #4: FG3246 in the prostate

Speaker #4: cancer treatment paradigm.

Speaker #1: Enjoy the rest of your day. Thanks, everybody.

Speaker #4: In addition,

Speaker #4: FG3180 could represent an important

Speaker #4: This concludes today's conference call. Thank you. Thank you for participating. You may now disconnect.

Speaker #4: commercial opportunity as a

Speaker #3: Slide 8 highlights the design of the investigator-initiated phase 1B/2 trial of FG3246 in combination with Enzalutamide and MCRPC, for which top-line results were presented at the recent ASCO GU meeting.

Speaker #4: companion diagnostic to

Speaker #4: FG3246. Similar to the

Speaker #4: existing PSMA PET agents,

Speaker #4: which generated revenue of almost $2

Speaker #4: billion in

Speaker #4: 2025. Slide eight highlights

Speaker #4: the design of the investigator-initiated

Speaker #3: These results shown on slide 9 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.

Speaker #4: phase 1B/2

Speaker #4: trial of

Speaker #4: FG3246 in combination with Enzalutamide in

Speaker #4: MCRPC, for which

Speaker #4: Top-line results were presented at the recent

Speaker #4: ASCO GU meeting. These

Speaker #4: results shown on slide

Speaker #4: nine demonstrated encouraging

Speaker #3: Importantly, in patients who had progressed on one prior ARPI, the combination of FG3246 and Enzalutamide achieved a median RPFS of 10.1 months and demonstrated a PSA 50 response of 40%.

Speaker #4: anti-tumor activity with seven months

Speaker #4: of median radiographic progression-free

Speaker #4: survival in biomarker

Speaker #4: unselected patients across the entire

Speaker #4: cohort of 44

Speaker #4: patients. Importantly, in patients who had

Speaker #4: progressed on one prior

Speaker #3: Notably, on slide 10, higher tumor uptake of FG3180 was associated with PSA 50 response, underscoring the potential for FG3180 as a PET imaging biomarker for patient selection.

Speaker #4: ARPI, the combination of

Speaker #4: FG3246 and Enzalutamide

Speaker #4: achieved a median RPFS of

Speaker #4: 10.1 months and demonstrated a

Speaker #4: PSA 50 response, a

Speaker #4: 40%. Notably,

Speaker #4: on slide

Speaker #4: 10, higher tumor uptake of

Speaker #3: On the right-hand part of the slide is an example of a PET image from the IST captured after treatment with FG3180, highlighting significant CD46 expressing tumors.

Speaker #4: FG3180 was associated with

Speaker #4: PSA 50 response, underscoring

Speaker #4: the potential for

Speaker #4: FG3180 as a PET imaging

Speaker #4: biomarker for patient

Speaker #4: selection. On the right-hand part of the slide is an

Speaker #3: The table on the left shows the correlation between tumor uptake of FG3180 and PSA. 50 response. Patients with a higher average maximum standardized uptake value or SUV of a target lesion when normalized to the SUV of the blood pool demonstrated a trend to greater response to FG3246, as measured by PSA 50 versus those with a lower SUV, with a nominal p-value that just missed being statistically significant.

Speaker #4: example of a PET image from

Speaker #4: the IST captured after

Speaker #4: treatment with FG3180,

Speaker #4: highlighting significant CD46

Speaker #4: expressing tumors.

Speaker #4: The table on the left shows the correlation.

Speaker #4: between tumor uptake of

Speaker #4: FG3180 and PSA 50

Speaker #4: response. Patients with

Speaker #4: a higher average maximum

Speaker #4: standardized uptake value or

Speaker #4: SUV of a target lesion when

Speaker #4: normalized to the SUV of the blood

Speaker #4: pool demonstrated a

Speaker #4: trend to greater response to

Speaker #3: This data demonstrates for the first time an association between CD46 expression and response to FG3246. Further evaluation of FG3180 is an important part of the ongoing phase two monotherapy trial.

Speaker #4: FG3246 as measured by

Speaker #4: PSA 50 versus those with a

Speaker #4: lower SUV, with a

Speaker #4: nominal p-value that just missed being

Speaker #4: statistically significant.

Speaker #4: This data demonstrates for the first

Speaker #4: time an association

Speaker #4: between CD46 expression

Speaker #3: Finally, on slide 11, the combination of FG3246 and Enzalutamide had a similar safety profile to what was observed in the FG3246 phase one monotherapy trial.

Speaker #4: and response to

Speaker #4: FG3246. Further evaluation of

Speaker #4: FG3180 is an important part of

Speaker #4: the ongoing phase two

Speaker #4: monotherapy trial.

Speaker #4: Finally, on slide 11, the combination of

Speaker #3: Importantly, the incidence of grade 3 or greater neutropenia was substantially reduced with the utilization of GCSF prophylaxis when compared to the phase one monotherapy trial.

Speaker #4: FG3246 and

Speaker #4: Enzalutamide had a similar safety profile to what

Speaker #4: was observed in the

Speaker #4: FG3246 phase one monotherapy

Speaker #4: trial. Importantly, the

Speaker #3: This approach is an important design element of our ongoing phase two monotherapy trial. In summary, the results of the IST provide us with the key insights that further validate design elements in our ongoing phase two monotherapy trial.

Speaker #4: incidence of grade three or greater

Speaker #4: neutropenia was substantially reduced

Speaker #4: with the utilization of GCSF

Speaker #4: prophylaxis when compared to the phase

Speaker #4: one monotherapy trial. This

Speaker #4: Approach is an important design element of our

Speaker #4: ongoing phase two monotherapy

Speaker #3: Which we believe has the potential to improve upon the median RPFS observed in the phase one monotherapy trial, which I will cover in greater detail next.

Speaker #4: trial. In summary, the

Speaker #4: Results of the IST provide us with

Speaker #4: The key insights that further validate design elements in our ongoing Phase Two monotherapy trial.

Speaker #3: Briefly, on slide 12, we recap the top-line results from the phase one monotherapy study of FG3246, which we believe are competitive when compared to other approved and investigational treatments.

Speaker #3: These results demonstrated a median RPFS of 8.7 months in patients with MCRPC that were heavily pretreated and were not biomarker selected. PSA reductions of greater than 50% in this population were achieved in 36%.

Speaker #3: Of these patients. Moving to slide 13, based on the phase one monotherapy results, we initiated the FG3246 phase two monotherapy dose optimization trial in September.

Speaker #3: We plan to enroll. 25 patients in the post-ARPI pre-chemo setting across three dose levels to determine the optimal dose for phase three based on efficacy, safety, and PK parameters.

Speaker #3: It is important to note that 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 and determine whether there is further correlation between CD46 expression and response to the ADC in this all-commerce phase two trial.

Speaker #3: In interim analysis of the open-label phase two trial is planned for the second half of 2026. And we'll include PSA 50, ORR, safety, PK, and exposure response data.

Thane Wettig: Which we believe has the potential to improve upon the median RPFS observed in the phase 1 monotherapy trial, which I will cover in greater detail next. Briefly on slide 12, we recap the top-line results from the phase 1 monotherapy study of FG-3246, which we believe are competitive when compared to other approved and investigational treatments. These results demonstrated a median RPFS of 8.7 months in patients with mCRPC that were heavily pretreated and were not biomarker selected. PSA reductions of greater than 50% in this population were achieved in 36% of these patients. Moving to slide 13. Based on the phase 1 monotherapy results, we initiated the FG-3246 phase 2 monotherapy dose optimization trial in September.

Speaker #3: Importantly, we expect mature RPFS data to become available in 2027 as patients continue on their treatment with FG3246 and the trial progresses toward completion.

Speaker #3: On slide 14, I'd like to highlight three important steps we have taken with the design of the ongoing phase two monotherapy trial which were further validated with the IST results as we aim to improve upon the 8.7 months of median RPFS demonstrated in the phase one monotherapy trial.

Speaker #3: First, leveraging earlier evidence of an exposure response relationship, the phase two study is using three of the highest doses from the phase one dose escalation and expansion study.

Thane Wettig: We plan to enroll 75 patients in the post ARPI pre-chemo setting across 3 dose levels to determine the optimal dose for Phase 3 based on efficacy, safety, and PK parameters. It is important to note that FG-3180 will be an integral part of the study as we seek to further explore what was demonstrated in the Phase 1b/2 combination trial and determine whether there is further correlation between CD46 expression and response to the ADC in this all-comers Phase 2 trial. An interim analysis of the open label Phase 2 trial is planned for the second half of 2026 and will include PSA50, ORR, safety, PK, and exposure response data. Importantly, we expect mature RPFS data to become available in 2027 as patients continue on their treatment with FG-3246 and the trial progresses toward completion.

Speaker #3: Second, primary prophylaxis with GCSF is utilized to mitigate neutropenia, which was successfully demonstrated in the phase two portion of the recently disclosed IST. The mitigation of neutropenia could enable more consistent exposure to the ADC with fewer dose interruptions or adjustments early in the course of treatment, which could extend the duration of therapy and potentially enhance the efficacy of the ADC.

Speaker #3: Third, we are enrolling healthier patients in earlier lines of therapy versus the median five prior lines of therapy in the phase one trial. The 10.1 months of median RPFS demonstrated in the IST in patients who progressed on only one prior ARPI underscores the potential of FG3246 in this patient population.

Speaker #3: Together with the insights from the IST results, we believe that these design elements have the potential to improve upon the phase one results and achieve a median RPFS of 10 months or greater, which we believe is the benchmark for commercial competitiveness.

Thane Wettig: On slide 14, I'd like to highlight 3 important steps we have taken with the design of the ongoing phase 2 monotherapy trial, which were further validated with the IST results as we aim to improve upon the 8.7 months of median RPFS demonstrated in the phase 1 monotherapy trial. First, leveraging earlier evidence of an exposure-response relationship, the phase 2 study is using 3 of the highest doses from the phase 1 dose escalation and expansion study. Second, primary prophylaxis with G-CSF is utilized to mitigate neutropenia, which 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 with fewer dose interruptions or adjustments early in the course of treatment, which could extend the duration of therapy and potentially enhance the efficacy of the ADC.

Speaker #3: Slide 15 highlights the recent and upcoming catalysts for the FG3246 and FG3180 program. We are actively enrolling patients and are on track to report the interim results from the phase two monotherapy trial in the second half of this year.

Speaker #3: To summarize, on slide 16, FG3246 targets a novel epitope on prostate cancer cells with first-in-class potential given there are no other CD46 targeted projects in clinical development and no non-PSMA approaches in mid to late-stage development with a companion PET imaging approach.

Speaker #3: Targeting CD46 with FG3246 has already signals with an acceptable safety profile both in monotherapy in combination settings. We have a well-designed phase two monotherapy trial in the post-ARPI pre-chemo setting in MCRPC to further attempt to further build upon the 8.7 months of median RPFS demonstrated in the phase one trial.

Thane Wettig: Third, we are enrolling healthier patients in earlier lines of therapy versus the median 5 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 FG-3246 in this patient population. Together with the insights from the IST results, we believe that these design elements have the potential to improve upon the phase 1 results and achieve a median RPFS of 10 months or greater, which we believe is the benchmark for commercial competitiveness. Slide 15 highlights the recent and upcoming catalysts for the FG-3246 and FG-3180 program. We are actively enrolling patients and are on track to report the interim results from the phase 2 monotherapy trial in the second half of this year.

Speaker #3: We are looking forward to the interim readout later this year, and we'll update you as the program progresses. Turning now to Roxidustat. Slide 18 highlights the unmet need and the potential for Roxidustat in the approximately 49,000 patients with anemia associated with lower-risk MDS in the US alone.

Speaker #3: 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.

Thane Wettig: To summarize on slide 16, FG-3246 targets a novel epitope on prostate cancer cells with first-in-class potential, given there are no other CD46 targeted projects in clinical development and no non-PSMA approaches in mid to late-stage development with a companion PET imaging approach. Targeting CD46 with FG-3246 has already demonstrated promising early efficacy signals with an acceptable safety profile, both in monotherapy and combination settings. We have a well-designed phase 2 monotherapy trial in the post ARPI pre-chemo setting in mCRPC to attempt to further build upon the 8.7 months of median RPFS demonstrated in the phase 1 trial. We are looking forward to the interim readout later this year, and we'll update you as the program progresses. Turning now to Roxadustat.

Speaker #3: Moving to slide 19, I would like to quickly highlight the data from a post-hoc analysis in a subgroup of patients with anemia of lower-risk MDS who entered the phase three Matterhorn study of Roxidustat with a high transfusion burden.

Speaker #3: In this analysis, using the International Working Group definition for high transfusion burden, of four or more RBC units in two consecutive eight-week periods, Roxidustat showed a meaningful treatment effect with 36% of patients achieving transfusion independence for at least eight weeks versus only 7% in the placebo group with a nominal p-value of 0.041.

Speaker #3: These results are highly similar to the pivotal trial results for the two most recently approved therapies for anemia associated with lower-risk MDS. Based on these results, as we turn to slide 20, our target indication for Roxidustat is in patients with lower-risk MDS who are refractory to or ineligible for prior ESA treatment, where we believe Roxidustat has the potential to elevate the standard of care across multiple treatment lines.

Thane Wettig: Slide 18 highlights the unmet need and the potential for Roxadustat in the approximately 49,000 patients with anemia associated with lower-risk MDS in the US alone. Current treatments, as measured by transfusion independence, are effective in less than 50% of patients. With no oral options currently on the market or in late-stage development, a significant opportunity exists to offer a potential new treatment that is durable with convenient oral administration to patients across multiple lines of therapy. Moving to slide 19, I would like to quickly highlight the data from a post-hoc analysis in a subgroup of patients with anemia of lower-risk MDS who entered the Phase 3 MATTERHORN study of Roxadustat with a high transfusion burden.

Speaker #3: In addition, we believe we have an opportunity to demonstrate efficacy across both RS-positive and RS-negative patients. When looking at the prevalence of the disease, RS-negative patients make up more than 50% of patients in lower-risk MDS.

Speaker #3: There is a great opportunity to potentially move upline and help these patients given that loose battleship does not approve in the second-line setting in RS-negative patients.

Speaker #3: Moving to slide 21, after aligning with the FDA last summer on key design elements of a phase three trial, we submitted the final protocol to the FDA and expect to receive their feedback in the coming weeks.

Thane Wettig: In this analysis, using the International Working Group definition for high transfusion burden of 4 or more RBC units in 2 consecutive 8-week periods, Roxadustat showed a meaningful treatment effect, with 36% of patients achieving transfusion independence for at least 8 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.

Speaker #3: We are currently exploring the opportunity to develop Roxidustat internally or with a strategic partner and aim to initiate this study in the second half of 2026.

Speaker #3: To summarize on slide 22, there is significant opportunity for Roxidustat in anemia associated with lower-risk MDS with no other oral treatments currently available or in late-stage development.

Speaker #3: With Roxidustat being granted orphan drug designation, we believe that a minimum of seven years of regulatory exclusivity combined with an attractive market opportunity and efficient commercial model represents a substantial economic opportunity for Roxidustat in anemia associated with lower-risk MDS.

Thane Wettig: Based on these results, as we turn to slide 20, our target indication for Roxadustat is in patients with lower-risk MDS who are refractory to or ineligible for prior ESA treatment, where we believe Roxadustat has the potential to elevate the standard of care across multiple treatment lines. In addition, we believe we have an opportunity to demonstrate efficacy across both RS-positive and RS-negative patients. When looking at the prevalence of the disease, RS-negative patients make up more than 50% of patients in lower-risk MDS. There is a great opportunity to potentially move upline and help these patients, given that Luspatercept is not approved in the second line setting in RS-negative patients.

Speaker #3: With that, I will now turn the call over to Dave to discuss the company's financials. Dave?

Speaker #2: Thank you, Thane. For the fourth quarter of 2025, total revenue was $1.3 million, compared to $3.1 million for the same period in 2024. For a full year 2025, total revenue was $6.4 million, compared to $29.6 million for the full year 2024.

Speaker #2: Now moving down the income statement. Total operating costs and expenses for the fourth quarter of 2025 were $14.8 million, compared to $10.3 million for the fourth quarter of 2024.

There is a great opportunity to potentially move upline and help these patients, given that Luspatercept does not approved. In the second-line setting in RS negative patients,

Thane Wettig: Moving to slide 21, after aligning with the FDA last summer on key design elements of a phase 3 trial, we submitted the final protocol to the FDA and expect to receive their feedback in the coming weeks. We are currently exploring the opportunity to develop Roxadustat internally or with a strategic partner and aim to initiate this study in the second half of 2026. To summarize on slide 22, there is significant opportunity for Roxadustat in anemia associated with lower-risk MDS, with no other oral treatments currently available or in late-stage development. With Roxadustat being granted Orphan Drug Designation, we believe that a minimum of 7 years of regulatory exclusivity, combined with an attractive market opportunity and efficient commercial model, represents a substantial economic opportunity for Roxadustat in anemia associated with lower-risk MDS.

Speaker #2: Total operating expense costs and expenses for full year 2025 were $52.3 million, compared to $180 million for full year 2024. R&D expenses for the fourth quarter of 2025 were $7.3 million, compared to $6.9 million in the fourth quarter of 2024.

Moving to slide 21, after aligning with the FDA last summer on key design elements of a Phase 3 trial, we submitted the final protocol to the FDA and expect to receive their feedback in the coming weeks.

We are currently exploring the opportunity to develop rocks, induced internally or with the strategic partner, and aim to initiate this study in the second half of 2026.

Speaker #2: And R&D expenses for full year 2025 were $23.5 million, compared to $95.7 million in full year 2024. SG&A expenses for the fourth quarter of 2025 were $7.3 million, compared to $8.3 million in the fourth quarter of 2024.

To summarize, on slide 22. There is significant opportunity for roxadustat to reduce debt in anemia associated with lower-risk MDS, with no other oral treatments currently available or in late-stage development.

Speaker #2: SG&A expenses for full year 2025 were $27.7 million, compared to $49.3 million in full year 2024. During the fourth quarter of 2025, we recorded a net loss from continuing operations of $14.6 million or $3.61 net loss per basic and diluted share as compared to a net loss of $8.7 million or $2.15 per basic and diluted share for the fourth quarter of 2024.

With rockstad being granted, orphan drug designation, we believe that a minimum of 7 years of regulatory exclusivity combined with an attractive Market opportunity and efficient commercial model. Represent represents a substantial Economic Opportunity for rocks to do that in anemia associated with lower risk MDS.

Thane Wettig: With that, I will now turn the call over to David DeLucia to discuss the company's financials. David DeLucia?

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 Q4 of 2025, total revenue was $1.3 million compared to $3.1 million for the same period in 2024. For full year 2025, total revenue was $6.4 million compared to $29.6 million for the full year of 2024. Now moving down the income statement. Total operating costs and expenses for the Q4 of 2025 were $14.8 million compared to $10.3 million for the Q4 of 2024. Total operating costs and expenses for full year 2025 were $52.3 million compared to $180 million for full year 2024.

Thank you, Sean. For the fourth quarter of 2025, total revenue was $1.3 million compared to $3.1 million for the same period in 2024.

For the full year 2025, total revenue was $6.4 million, compared to $29.624 million.

Speaker #2: During full year 2025, we recorded a net loss from continuing operations of $58.2 million or $14.40 net loss per basic and diluted share as compared to a net loss of $153.1 million or $38.26 per basic and diluted share for the full year 2024.

Now, moving down the income statement.

Total operating costs and expenses for the fourth quarter of 2025 were $14.8 million compared to $10.3 million for the fourth quarter of 2024.

Speaker #2: Now shifting towards cash. As of December 31st, we reported $109.4 million in cash, cash equivalents, investments, and accounts receivable. We expect the company to have cash runway into 2028.

Total operating expense costs and expenses for full year 2025 were $52.3 million, compared to $180 million for the full year 2024.

David DeLucia: R&D expenses for Q4 2025 were $7.3 million compared to $6.9 million in Q4 2024. R&D expenses for full year 2025 were $23.5 million compared to $95.7 million in full year 2024. SG&A expenses for Q4 2025 were $7.3 million compared to $8.3 million in Q4 2024. SG&A expenses for full year 2025 were $27.7 million compared to $49.3 million in full year 2024.

R&D expenses for the fourth quarter of 2025 were $7.3 million, compared to $6.9 million in the fourth quarter of 2024.

Speaker #2: In summary, 2025 was a transformational year for the company, and we have taken important steps to reduce our fixed cost infrastructure to maximize our cash runway and enable investment in our US pipeline opportunities.

And R&D expenses for the full year 2025 were $23.5 million, compared to $95.7 million in the full year 2024.

Speaker #2: Thank you, and I will now turn the call back over to Thane.

SG&A expenses for the fourth quarter of 2025 were $7.3 million, compared to $8.3 million in the fourth quarter of 2024.

Speaker #3: Thank you, Dave. We are well capitalized to support multiple clinical milestones into 2028 and remain laser-focused on advancing FG3246 and its companion FG3180 program with expected interim analysis from the phase two monotherapy trial in the second half of 2026.

David DeLucia: During the Q4 of 2025, we recorded a net loss from continuing operations of $14.6 million or $3.61 net loss per basic and diluted share, as compared to a net loss of $8.7 million or $2.15 per basic and diluted share for the Q4 of 2024. During full year 2025, we recorded a net loss from continuing operations of $58.2 million or $14.40 net loss per basic and diluted share, as compared to a net loss of $153.1 million or $38.26 per basic and diluted share for the full year of 2024. Now shifting towards cash.

SG&A expenses for full year 2025 were $27.7 million, compared to $49.3 million in full year 2024.

Speaker #3: We look forward to finalizing the phase three protocol for Roxidustat MDS and are targeting initiation of the trial in the second half of 2026.

During the fourth quarter of 2025, we recorded a net loss from continuing operations of $14.6 million, or $3.61 net loss per basic and diluted share, as compared to a net loss of $8.7 million, or $2.15 per basic and diluted share for the fourth quarter of 2024.

Speaker #3: In summary, 2025 was a transformational year for us on multiple fronts, and we are excited for the opportunities ahead. I would now like to turn the call over to the operator for Q&A.

Speaker #4: Thank you. As a reminder to ask a question, you will need to press star 11 on your telephone to remove yourself from the queue.

During full year 2025, we recorded a net loss from continuing operations of $58.2 million, or $0.1440 net loss per basic and diluted share, as compared to a net loss of $153.1 million, or $0.3826 per basic and diluted share for the full year 2024.

David DeLucia: As of December 31, we reported $109.4 million in cash equivalents, investments, and accounts receivable. We expect the company to have cash runway into 2028. In summary, 2025 was a transformational year for the company, and we have taken important steps to reduce our fixed cost infrastructure to maximize our cash runway and enable investment in our US pipeline opportunities. Thank you, and I will now turn the call back over to Thane.

Speaker #4: You may press star 11 again. Please stand by while we compile the Q&A roster. Our first question comes from the line of Andy Hsieh, of William Blair.

Cash equivalents, investments, and accounts receivable.

We expect the company to have cash runway into 2028.

Speaker #4: Your line is open, Andy.

Speaker #5: Thanks, thanks for taking our question. Two for us, if you don't mind. One has to do with maybe the imaging of CD46 opportunity. Maybe if you can kind of paint a picture for us just in the context of having PSMA imaging agents on the market now for three-plus years now, where would you think that this would fit in?

In summary, 2025 was a transformational year for the company, and we have taken important steps to reduce our fixed costs, improve our infrastructure to maximize our cash runway, and enable investment in our US pipeline opportunities. Thank you, and I will now turn the call back over to Thane.

Thane Wettig: Thank you, Dave. We are well-capitalized to support multiple clinical milestones into 2028 and remain laser-focused on advancing FG-3246 and its companion FG-3180 program, with expected interim analysis from the phase 2 monotherapy trial in the second half of 2026. We look forward to finalizing the phase 3 protocol for Roxadustat MDS and are targeting initiation of the trial in the second half of 2026. In summary, 2025 was a transformational year for us on multiple fronts, and we are excited for the opportunities ahead. I would now like to turn the call over to the operator for Q&A.

Thank you, Dave.

Speaker #5: And also the corresponding maybe commercial opportunity? So that's question number one. Question number two, for the SUV data obviously very provocative, having a correlation there.

We are well capitalized to support multiple clinical milestones into 2028 and remain laser focused on advancing FG-3246 and its companion FG-3180 program, with expected interim analysis from the Phase 2 monotherapy trial in the second half of 2026.

If you look forward to finalizing the phase 3 protocol for ROX, you said, MDS, and are targeting initiation of the trial in the second half of 2026.

Speaker #5: So if you think about it as a patient selection opportunity, can you help us think about some of the KOL feedback that kind of talks about SUV potentially as a way to enrich patients who will most likely benefit?

In summary, 2025 was a transformational year for us on multiple fronts, and we are excited for the opportunities ahead.

I would now like to turn the call over to the operator for Q&A.

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

Speaker #5: But on the other hand, there are also KOLs kind of talk about low SUV patients who also can benefit. So maybe help us understand those kind of two arguments in the field.

Thank you as a reminder, to ask a question. You will need to press star 1 1 1 on your telephone, to remove yourself from the queue. You may press star 1 1 1 again.

Please stand by while we compile the Q&A roster.

Speaker #5: Thank you so much.

Our first question.

Speaker #3: Yeah, thanks, Andy. Appreciate the question. I'll go ahead and kick it off, and then I'm going to ask Carol to add to it. So first, related to imaging and CD46 and how that would compare and contrast to PSMA agents which have been on the market, to your point, for three-plus years and by the time we would make it to market, obviously several years beyond that.

Coming from the line of Andy Shay of William Blair. Your line is open, Andy.

Andy Hsieh: Thanks, thanks for taking our question. Two for us, if you don't mind. One has to do with maybe the imaging of CD46 opportunity. Maybe if you can kind of paint a picture for us just in the context of having PSMA imaging agents on the market now for 3+ years now, where would you think that this would fit in and also the corresponding maybe commercial opportunity? That's question number one. Question number two, for the SUV data, obviously very provocative having a correlation there. If you think about it as a patient selection opportunity, can you help us think about some of the KOL feedback that kind of talks about SUV potentially as a way to enrich patients who will most likely benefit.

Well, thanks. Uh, thanks for taking our question. Uh, two, um, for us if you don't mind. One has to do with, uh, maybe the imaging of CD46 opportunity. Maybe if you can kind of paint a picture for us, just in the context of—

Speaker #3: And also around the commercial opportunity, and then kind of potential sequencing, which I think was maybe part of your question. So clearly, if we were able to make it to market, Plovikto in this post-ARPI pre-chemo setting, we would anticipate being pretty well entrenched there.

Speaker #3: And as I'm sure you know, Andy, because you cover the space, in order for a patient to be prescribed Plovikto, they have to undergo a treatment with a PSMA PET imaging agent, undergo a PET scan, and be positive, have show positive uptake of PSMA PET.

Having psma Imaging agents on the market. Now, for 3 plus years now. Um, where would you think that um this would would fit in and also the the corresponding maybe commercial opportunity. Um, so that's question. Number 1, question number 2 for the SUV data, uh, obviously very provocative having a correlation there. Um, so if, if you think about it as a patient selection opportunity, um,

Speaker #3: We would anticipate the same thing for our PSMA or our CD46 PET agent. And so the great thing is that Plovikto and the products from Lanthus and Telex have pretty much created the playbook, and we're trying to run that exact same playbook.

Andy Hsieh: On the other hand, there are also KOLs kinda talk about low SUV patients who also can benefit. So, maybe help us understand those kind of two arguments in the field. Thank you so much.

Can you help us? Think about, um, some of the KO feedback that kind of talks about SUV potentially as a as a way to enrich patients, who will most likely benefit? But on the other hand, there are also KO is going to talk about low SUV patients, who also can benefit. So so maybe help us understand those kind of 2 arguments in in in the season.

Field, thank you so much.

Thane Wettig: Yeah. Thanks, Andy. Appreciate the question. I'll go ahead and kick it off, and then I'm gonna ask Carol to add to it. First, related to, you know, imaging and CD46 and how that, you know, would compare and contrast to PSMA agents, you know, which have been on the market, to your point, for, you know, 3+ years, and by the time we would make it to market, obviously several years beyond that and also around the commercial opportunity. Then kind of potential sequencing, which I think was maybe part of your question. Clearly, you know, if we were able to make it to market, you know, Pluvicto, in this, post ARPI pre-chemo setting, you know, we would anticipate being pretty well entrenched there.

Speaker #3: And so we would anticipate that if FG3246 makes it to market, that the FDA would label FG3246 fairly similarly to how Plovikto was labeled, that patients must undergo treatment with a CD46 PET imaging agent and be positive for CD46.

Speaker #3: And so we would think it would be in a similar sort of way. As it relates to the commercial opportunity, clearly we don't have the kind of expertise in this space that companies like Telex and Lanthus have.

Speaker #3: So as we further characterize the CD46 PET agent through the course of the phase two trial, we'll be further evaluating what role Kentra Bio should play versus what role could perhaps strategic partners play in the further development.

Thane Wettig: I'm sure you know, Andy, because you cover the space, in order for a patient to be prescribed Pluvicto, they'd have to undergo a treatment with a PSMA PET imaging agent, undergo a PET scan and be positive, show positive uptake of PSMA PET. We would anticipate the same thing for our PSMA or our CD46 PET agent. You know, the great thing is that Pluvicto and the products from Lantheus and Telix have pretty much created the playbook, and we're trying to run that exact same playbook.

Yeah, thanks Andy, appreciate the question. I'll go ahead and kick it off, and then I'm going to ask Carol to, uh, add to it. Um, so first, related to, um, you know, imaging and CD46, and how that, you know, would compare and contrast to PSMA agents, you know, which have been on the market, to your point, for, you know, three plus years. And by the time we would make it to market, obviously several years beyond that, and also around the commercial opportunity, uh, and then kind of potential sequencing, which I think was maybe part of your question. Um, so clearly, but, um, you know, if we were able to make it to market, you know, pull Pictou, um, in this post-ARPI, pre-chemo setting, you know, we would anticipate being pretty well entrenched there. And as I'm sure you know, Andy, because you cover, um, the, uh, the space. Um,

Speaker #3: But we think we're pretty well set as it relates to the phase two portion of the program. Carol, let me turn it over to you, and you can add to that.

Speaker #2: Yes, thank you for the question, Andy. We're very clear of the fact that we'll be in a world where there are multiple PET agents available for these patients, and our clinical development strategy for this companion diagnostic needs to be designed in a way to address the question around sequencing and when to use and when it's justified.

Speaker #2: We believe that with the differentiation that our ADC offers in positive in a patient with CD46 positive, that that would justify a PET scan and hence would provide this placement in the treatment algorithm.

Thane Wettig: We would anticipate that if FG-3246 makes it to market, that the FDA would label FG-3246 fairly similarly to how Pluvicto was labeled, that patients must undergo treatment with a CD46 PET imaging agent and be positive for CD46. We would think it would be in a similar sort of way. As it relates to the commercial opportunity, you know, clearly we don't have the kind of expertise in this space that companies like Telix and Lantheus have. As we further characterize the CD46 PET agent through the course of the phase 2 trial, we'll be further evaluating what role Kyntra Bio should play versus what role could perhaps strategic partners play in the further development.

In order for a patient to be prescribed Pictou, they have to undergo a treatment with a psma PET Imaging agent undergo a PSO or a pet scan and be positive have show. Positive uptake of psma. Pets. We would anticipate the same thing uh for our psma or our our cd46 pet agent. Um and so that you know, the great thing is is that um Pictou and um the the products from Atlantis and ticks have pretty much created The Playbook and we're trying to run that exact same Playbook and so we would anticipate

Speaker #2: But it's something that we're keenly aware of and raises the bar for development strategies in this space given the coexistence. I want to put that on your second question or back to you, Thane?

Speaker #3: Yeah, go ahead.

Speaker #2: Okay. Your second question around SUV and a really good one. The phase two is designed for us to understand how we define CD46 positivity.

Speaker #2: And that might be based on SUV, but might also be based on something else as we know as you mentioned that the field is also keen at looking at metrics outside of SUV.

Thane Wettig: We think we're pretty well set as it relates to the phase two portion of the program. Carol, let me turn it over to you, and you can add to that.

Pet agent through the course of the phase 2 trial. Um will be further evaluating what role um control bio should play versus what role could uh perhaps strategic Partners play in the further development. Um, but we think we're pretty well set as it relates to the phase 2 portion of the program.

Speaker #2: So maybe a bit early to comment on that. We look at that as part of the phase two. That's the clear benchmark that we need to hit before we can take this into the phase three to define positivity and the right metric.

Carol, let me turn it over to you, and you can—

add to that.

[Company Representative] (Kyntra Bio): Yes. Thank you for the question, Andy. We're very clear of the fact that we'll be in a world where there are multiple PET agents available for these patients, and our clinical development strategy for this companion diagnostic needs to be designed in a way to address the question around sequencing, and when to use and when it's justified. We believe that with the differentiation that our ADC offers in patients with CD46 positive, that would justify a PET scan and hence would provide this placement in the treatment algorithm. It's something that we're keenly aware of and raises the bar for development strategies in this space given the coexistence.

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

Speaker #3: So maybe just add a couple more comments. First, Andy, going back to that first question, let's say that a patient is prescribed Plovikto. The RLT after showing positivity for PSMA PET, and they ultimately progress on Plovikto, we would then with a non-PSMA approach, focus on CD46, we would then think it's highly possible for a patient to then be treated with PET-46, undergo a scan, and if they showed positivity for CD46, then be prescribed FG3246.

We were very, um, clear of the fact that we live in a, in a world where there are multiple PET agents available for these patients, and our clinical development strategy for this companion diagnostic needs to be designed in a way to address the question around sequencing and when to use, and when it's justified. Um, we believe that with the differentiation that our ADC offers in, uh, positive, in a patient, in patient, uh, with CD46 positive, um, that that would justify, um, a PET scan and hence what, uh, provides this. Um,

Speaker #3: So that's how we also tend to think about it from a sequencing perspective.

Speaker #4: That's super helpful. Look forward to the second half update. Thank you.

Thane Wettig: Thanks, Carol.

Displacement in the treatment algorithm, but it's something that we're keenly aware of and raises the bar for development strategies in this space, given the coexistence.

[Company Representative] (Kyntra Bio): I wanted to touch on your second question or back to you, Thane.

Carol Gaddum: I wanted to touch on your second question or back to you, Thane.

Speaker #3: Great. Thanks, Andy.

Um, on your second question or a key thing.

Thane Wettig: Yeah, go ahead.

Speaker #4: Thank you. Our next question. Comes from the line of Matthew Keller of HCW. Please go ahead, Matthew.

[Company Representative] (Kyntra Bio): Okay. Yeah, second question around SUV, and a really good one. The phase 2 is designed for us to understand how we define CD46 positivity, and that might be based on SUV, but might also be based on something else as we know, as you mentioned, that the field is also keen on looking at metrics outside of SUV. Maybe a bit early to comment on that. We look at that as part of the phase 2. That's the clear benchmark that we need to hit before we can take this into the phase 3 to define positivity and the right metric.

Carol Gaddum: Okay. Yeah, second question around SUV, and a really good one. The phase 2 is designed for us to understand how we define CD46 positivity, and that might be based on SUV, but might also be based on something else as we know, as you mentioned, that the field is also keen on looking at metrics outside of SUV. Maybe a bit early to comment on that. We look at that as part of the phase 2. That's the clear benchmark that we need to hit before we can take this into the phase 3 to define positivity and the right metric.

Speaker #5: Hey, good afternoon and thanks for taking our questions. Two from me as well, if that's okay. The first one, 3246 program, and this is a bit of a point of clarification.

Speaker #5: But based on these really positive ARPI results based on more efficacy seen in earlier stage of treatment, I was wondering, and I just want to be clear, are we expecting the balance of patients between the IST and the monotherapy study to be about the same?

Speaker #5: Or do you think there might be a difference, I guess, with recruitment or, I guess, the line of treatment you guys are thinking of recruiting?

Yeah, go ahead. Okay, uh, your second question around SUV, um, and a really good 1. Um, The Phase 2 is designed for us to understand, um, how we Define cd46 positivity and that might be based on SUV, but might also be based on something else as we know. If, if you mentioned that the the field is also Keen at looking, um, at at metrics outside of sqv. So maybe a bit early to comment on that. We look at that as part of the phase 2, that's the clear. Um, the clear um, Benchmark that we need to hit before. We can take this into the phase 3, to Define positivity and the right metric.

Thane Wettig: Let me maybe just add a couple more comments. First, Andy, going back to that first question. Let's say that a patient is prescribed Pluvicto, the RLT after showing positivity for PSMA PET, and they ultimately progress on Pluvicto. We would then, you know, with a non-PSMA approach, you know, focus on CD46. We would then think it's highly possible for a patient to then be treated with FG-3246, undergo a scan, and if they show positivity for CD46, then be prescribed FG-3246. That's how we also tend to think about it from a sequencing perspective.

Speaker #5: And then my second question on the ROXA program, I wondered if any updates, I guess, on the maturity level of potential partnering or BD efforts there.

Speaker #5: Thanks.

Speaker #3: Yeah, thanks, Matt, for the questions. I'll take the first one and then ask Carol to add anything else that might be relevant, and then I'll handle the ROXA tech question as well.

Speaker #3: First, in terms of kind of the ARPI efficacy, the balance of patients from the recently disclosed IST versus the ongoing phase two monotherapy, there were about 60% of patients from the IST that had been progressed on two or more ARPIs.

Tell Me, Maybe, Just Add a couple of more comments first, Andy going back to that first question, and let's say that the patient is prescribed Pictou. The, the rlt after um, showing positivity for psma pet. Um, and they ultimately progress on ficto we would then, you know, with a non psma approach, um, you know, focus on cd46 we would then, uh, think it's, it's highly possible for a patient to, then be treated with pet 46, undergo, a scan. And if they show showed positivity for cd46 then be prescribed, ft3 to 46. So, that's how we also tend to think about it from a, a sequencing perspective.

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

Thane Wettig: Great. Thanks, Andy.

That's super helpful. Look forward to the, uh, second half update. Thank you. Great, thanks Andy.

Speaker #3: About 40% of patients who had progressed on only one ARPI. In our phase two monotherapy, patients will have only progressed on one prior ARPI and be in the pre-chemo setting.

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

Thank you.

Our next question.

Comes from the line of Matthew Keller of HCW. Please go ahead, Matthew.

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

Speaker #3: And so that's, I think, a pretty important differentiator. So 100% of our patients in the phase two monotherapy trial will have progressed on one prior ARPI, whereas in the IST, about 40% of patients had progressed on only one and then 60% had progressed on two or more.

Hey, good afternoon, and uh, thanks for taking a question—two from me as well, if that's okay. Uh, the first one, uh, 3246 program, and this is a bit of a point of clarification. Um, but based on these really positive, uh, ARPI results based on, you know, more efficacy seen in an earlier stage of treatment.

Speaker #3: Carol, anything to add to that?

Speaker #2: The only thing to add on here is that the setting that we're looking at is really that established by PSMA 4. So it's looking for efficacy benchmarks that's really what we're targeting.

I was wondering, and I just want to be clear. Are we expecting the balance of patients between the ISC and the monotherapy study to be about the same?

Speaker #2: So it's post one prior ARSI.

Speaker #3: Okay. And then Matt, as it relates to the ROXA tech question, we're not going to comment on the specifics of where we are with respect to that effort, where we say we're evaluating the opportunity to develop an internally versus potentially having some sort of a collaboration with a strategic.

Or do you think there might be a difference? I guess with recruitment, or I guess the line of treatment you guys are thinking of recruiting. And then my second question, on the Rocks program, I wondered if you have any updates—I guess on the maturity level of, you know, potential partnering or BD efforts there? Thanks.

Thane Wettig: Yeah. Thanks, Matt, for the questions. I'll take the first one and then ask Carol to add anything else that might be relevant, and then I'll handle the Roxadustat question as well. First, in terms of the ARPI efficacy, the balance of patients from the recently disclosed IST versus the ongoing phase 2 monotherapy. There were about 60% of patients from the IST that had progressed on two or more ARPIs, about 40% of patients who had progressed on only one ARPI. In our phase 2 monotherapy, patients will have only progressed on one prior ARPI and be in the pre-chemo setting. That's, I think, a pretty important differentiator.

Speaker #3: We're continuing to explore both paths but we're not at a place right now where we can comment further on that.

Speaker #5: Yep. No, makes sense. Thanks again, guys.

Speaker #3: Great. Thank you, Matt. Appreciate the continued coverage.

Speaker #4: Thank you. Our next question comes from the line of Chen Lin of Lin Asset Management. Your line is open, Chen.

Speaker #6: All right. Thank you for taking my question. Most of my question has already been answered. I'm just curious about ROXA. The FDA is supposed to give feedback in 30 days.

Thane Wettig: You know, 100% of our patients in the phase 2 monotherapy trial will have progressed on one prior ARPI, whereas in the IST, about 40% of patients had progressed on only one, and then 60% had progressed on two or more. Carol, anything to add to that?

Speaker #6: Giving is often status why there's a seems to be a delay of the acceptance of the IND?

[Company Representative] (Kyntra Bio): The only thing to add on here is that the setting that we're looking at is really that established by PSMAfore. If looking for efficacy benchmarks, that's really what we're targeting. It's post one prior ARSI.

Carol Gaddum: The only thing to add on here is that the setting that we're looking at is really that established by PSMAfore. If looking for efficacy benchmarks, that's really what we're targeting. It's post one prior ARSI.

Speaker #3: Yeah. Thanks, Chen. When we submitted the protocol to the FDA, right before Christmas, we let the FDA know that we were not going to be imminently starting the phase three trial.

Speaker #3: And so what would typically happen is when a company is fully geared up to start the phase three and they submit the final protocol, the FDA typically gets back within 30 days.

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

Speaker #3: The FDA knew that they had a little bit more time. And so what they had signaled to us was 60 to 90 days. And we're right in that 60 to 90-day period right now.

Speaker #3: And so when we say that we expect feedback in the coming weeks, that's based upon the guidance that had been provided from the FDA when we had submitted the protocol in right before the holidays.

Matthew Keller: Yep. No, makes sense. Thanks again, guys.

Thane Wettig: Great. Thank you, Matt. Appreciate the continued coverage.

Speaker #6: Okay. Great. Thank you. Good luck.

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

Speaker #3: No, thanks, Chen. Appreciate the support.

Speaker #4: Thank you. I would now like to turn the conference back to Thane Wettig for closing remarks. Sir?

Chen Lin: Hi. Thank you for taking my questions. Actually, most of my question has been already answered. I just curious about Roxadustat. You know, the FDA is supposed to give feedback in 30 days, regarding its orphan status. Why there seems to be a delay of the, you know, acceptance of the IND?

Speaker #3: Yes. No, thank you. And thank you for joining us for today's fourth quarter and full-year in Kyntra Bio. Enjoy the rest of your day.

Speaker #3: Thanks, everybody.

Thane Wettig: Yeah. Thanks, Chen. When we submitted the protocol to the FDA right before Christmas, we let the FDA know that we were not going to be imminently starting the phase 3 trial. What would typically happens is, when a company is fully geared up to start the phase 3 and they submit the final protocol, the FDA typically gets back within 30 days. The FDA knew that they had a little bit more time. What they had signaled to us was 60 to 90 days, and we're right in that 60 to 90-day period right now.

Thane Wettig: When we say that we expect feedback in the coming weeks, that's based upon the guidance that had been provided from the FDA when we had submitted the protocol right before the holidays.

Chen Lin: Okay, great. Thank you. Good luck.

Thane Wettig: No, thanks, Chen. Appreciate the support.

Operator: Thank you. I would now like to turn the conference back to Thane Wettig for closing remarks. Sir?

Thane Wettig: Yes. No, thank you. Thank you for joining us for today's Q4 and Full Year Earnings Call, and we appreciate your interest in Kyntra Bio. Enjoy the rest of your day. Thanks, everybody.

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

[Company Representative] (Kyntra Bio): Okay.

Carol Gaddum: Okay.

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