Kyntra Bio : Reports First Quarter 2026 Financial Results

Published: 2026-05-11 16:15:18 ET KYNB

Published on 05/11/2026 at 04:15 pm EDT

May 11, 2026

Advancing mid- and late-stage assets in prostate cancer and rare disease; cash runway into 2028

FG-3246 G FG-3180: Attractive Assets in Prostate Cancer, Phase 2 Trial Enrolling

FG-3246, a potential first-in-class, CD46 targeting ADC, with a validated payload, clinically meaningful responses in previous mCRPC trials and a well-characterized safety profile

FG-3180, a PET imaging agent with demonstrated uptake in CD46 positive tumors, in development as potential novel patient selection biomarker

Currently enrolling Phase 2 monotherapy trial of FG-3246 and FG-3180 in mCRPC, post-ARPI / pre-chemo setting; interim analysis expected in 4Ǫ 2026

Roxadustat: A Phase-3 Ready Development Opportunity

Approved in > 40 countries and commercialized by AstraZeneca and Astellas for anemia associated with CKD; >1 million patients treated worldwide since 2019

Compelling wholly owned, Phase 3-ready U.S. development opportunity in anemia due to LR-MDS and high red blood cell transfusion burden

Reached agreement with the FDA on important Phase 3 clinical trial design elements, providing a regulatory pathway forward

Orphan Drug Designation in MDS granted by FDA in December 2025

Recent and Near-Term Catalysts

FG-3246 Phase 2 monotherapy trial interim results expected in 4Ǫ 2026

Roxadustat Phase 3 LR-MDS trial anticipated to commence in 2H 2026*

ADC=antibody drug conjugate; LR-MDS=low-risk myelodysplastic syndromes; mAb=monoclonal antibody; mCPRC=metastatic castration-resistant prostate cancer; SOC=standard of care.

*Costs of an internally run Phase 3 LR-MDS study are not included in current cash runway projections.

CD46

Multi-functional protein, overexpressed in cancer

Negatively regulates the complement system and helps tumors evade complement-dependent cytotoxicity

Highly expressed in mCRPC and other solid tumors with limited expression in normal tissues

Expression is up-regulated as prostate cancer progresses from localized castration-sensitive prostate cancer to mCRPC

50%-70% of mCRPC patients are estimated to have high expression of CD46

Expressed more homogenously and at higher levels compared to PSMA

Su Y, et al. JCI Insight. 2018; 3(17):e121497.

Lin, C., Hadfield, M.J., Santopietro, A. et al. The evolving landscape of antibody-drug conjugates (ADCs) for treatment of prostate cancer. npj Precis. Onc. 9, 351 (2025). https://doi.org/10.1038/s41698-025-01131-0

FG-3246

Therapeutic

FG-3180 PET

Imaging Agent

Targeting antibody + MMAE payload

YS5 antibody: Offers an androgen receptor agnostic and non-PSMA approach

MMAE: a potent anti-microtubule agent (validated chemotherapy)

Payload and linker approved in five marketed ADCs, generating ~$5 billion in 2025 net revenue

YS5 is a fully-human, full length, IgG1 mAb to tumor-selective epitope of CD46 that is:

Less accessible on most normal cells

Does not interfere with complement system regulation

Targeting antibody + 8GZr tracer

Demonstrated specific uptake in CD46 positive tumors

Potential to inform patient selection

PET-based biomarker currently considered superior to CD46 IHC in prostate cancer

Development strategy aims to achieve clinically differentiated profile in competitive yet dissatisfied mCRPC market

Phase 1 dose escalation and expansion study results in biomarker unselected and heavily pre-treated patient population with median of 5 prior lines of therapy

~36%

PSA Decline by

>50%

~20%

ORR

7.5

months

Median DOR

Range:

4.53 - 9.69

8.7

months Median rPFS

95% CI:

5.49 - 11.14

Efficacy analysis included 40 patients from the dose escalation cohorts-level > 1.2 mg/kg and cohort 1 (adenocarcinoma) of the dose expansion cohort at

2.7 mg/kg AJBW

2.7 mg/kg AJBW declared as the MTD in the study

DOR=duration of response; ORR=overall response rate; rPFS=radiographic progression free survival; PSA=prostate specific antigen.

Encouraging FG-3246 anti-tumor activity in patients with mCRPC observed, particularly in patients progressing on only 1 prior ARPI

Neutropenia risk was successfully mitigated with use of G-CSF prophylaxis

Phase 1b/2 results in biomarker unselected patients,

majority of who progressed on ≥2 prior ARPIs

months

22%

Median rPFS

PSA50 Response

Phase 1b/2 results in patients who progressed

on 1 prior ARPI*

months

40%

Median rPFS

PSA50 Response

*Median rPFS similar across different ARPIs (abiraterone, enzalutamide,

apalutamide, and darolutamide )

PSA50 Response

P-value

Yes (n=7)

No (n=16)

SUVmax-ave

11.68

[9.91-13.88]

9.24

[7.98-10.64]

0.109

SUVmax-ave/ SUVmean blood pool

G.57 [G.24-11.G3]

7.58 [6.66-G.80]

0.053

Results demonstrate FG-3180's potential as PET imaging biomarker for patient selection; further evaluation ongoing in the Phase 2 monotherapy trial

Interim results expected in 4Ǫ 2026

Primary Endpoint: Optimal dose for Phase 3 based on

efficacy, safety, and PK

Secondary Endpoints: rPFS, PSA50, PSA90

Exploratory Endpoint: FG-3180 (PET imaging agent) as a diagnostic radiopharmaceutical

Arm B: Dose Level 2 (N=25):

2.4 mg/kg AJBW

All arms will use primary prophylaxis with G-CSF

Arm C: Dose Level 3 (N=25):

2.7 mg/kg AJBW

Arm A: Dose Level 1 (N=25)

1.8 mg/kg AJBW

1:1:1 Randomization

Phase 2 - FG-3246 Dose Optimization in Post-ARPI, Pre-Chemo mCRPC, All Comers (US only)

Safety Review Committee

Planned review when 10 patients in each arm complete cycle 1

Planned review when 25 patients in each arm complete cycle 1

Ad hoc as needed

Expected

4Ǫ 2026

Interim

Analysis

Planned for up to 12 weeks after 12 patients in each arm are enrolled

DMC recommendation based on futility analysis and review of other available efficacy, safety, PK and E-R data

Futility evaluated by Composite Response Rate (PSA50/ORR)

Final Analysis

Planned for 12 months post N=25 enrolled in each cohort

Benefit/Risk assessment (Recommended Phase 3 Dose)

Decision on FG-3180 for patient pre-selection in Phase 3

Further validated by Phase 1b/2 Combination IST

Use of three of the highest doses (1.8mg/kg; 2.4mg/kg; 2.7mg/kg), given the exposure response established during the Phase 1 dose escalation and expansion trial

Use of primary prophylaxis G-CSF to help mitigate MMAE-associated adverse events like neutropenia, and maintain patients on their drug regimen longer

Moving upline to patients who have progressed on one prior ARPI - 1L or 2L mCRPC treatment as opposed to 5L+ in the Phase 1 monotherapy trial

Interim analysis expected in 4Ǫ 2026

Clinical Sites Currently Activated and in Startup

Activated

In Startup

Anemia is the hallmark symptom of MDS that gives rise to significant morbidity

Prevalence, United

States, 2022

58K

Patients are LR-MDS

4GK

Patients with anemia in LR-MDS

85% diagnosed with anemia

~77%

diagnosed with LR-MDS*

75K

Diagnosed with MDS

~75K

patients live with MDS in the U.S.

~G0% suffering from anemia and its

negative impact on quality of life

Current 1L agents are effective in <50% patients and relief is often temporary with limited treatment options in 2L+

Despite recent approvals, there remains a significant unmet need in the refractory population for additional treatments that provide durable response and the convenience of oral administration

SOCs are challenging to dose-calibrate and can only be administered through in-practice IV infusion or subǪ injection

SEER, 2025 ; DRG 2023, Fenaux et al, Leukemia (2018); Platzbecker et al, Leukemia (2017).

In patients with high transfusion burden1, roxadustat showed promising TI benefits compared to placebo

8-wk RBC TI

within 52 weeks2

8-wk RBC TI

within 28 weeks2

p=0.041

p=0.043

45%

36%

13%

No. of patients with response (% [65% CI])

Roxadustat (n=22)

Placebo (n=15)

8-wk RBC TI

within 28 weeks2

(36% [17-56])

(7% [0-32])

8-wk RBC TI

within 52 weeks2

(45% [24-68])

(13% (2-40])

Patients with TI, %

30 Final analysis data cut-off date: Aug 2, 2023

Full analysis population (all randomized patients who received ≥1 dose of study drug and had ≥1 corresponding on-treatment Hb assessment)

1High transfusion burden at baseline defined by IWG2018: ≥4 pRBC units in two consecutive 8-

week periods prior to randomization

10 2Post-hoc analysis with nominal p-values

Roxadustat

Placebo

Roxadustat

Placebo

CI, confidence interval; pRBC, packed red blood cells; TI, transfusion independence

Target indication:

Treatment of anemia in patients with LR-MDS who are refractory to, intolerant to, or ineligible for, prior ESA treatment

Del(5q) (~10%)

RS+ (30-40%)

RS-(50-60%)

1L Lenalidomide

Luspatarcept

ESA1

Luspatercept

2L+ Lenalidomide or

ESA

imetelstat

Roxadustat

imetelstat Roxadustat

RS = ring sideroblasts.

1. NCCN preferred is ESA, luspatercept approved in this setting. 2. Luspatercept not approved in 2L+ RS- MDS anemia.

Currently exploring the opportunity to develop internally or with a strategic partner

Patient Population

High transfusion burden: Patients requiring ≥ 4 pRBC units in two consecutive 8-week periods prior to randomization

Refractory to, intolerant to, or ineligible for prior ESAs

Safety

Management of potential thrombotic risk through:

Eligibility criteria

Dose modification criteria

Discontinuation criteria

Efficacy

Primary endpoint: ≥8-week RBC-TI response rate

Key secondary endpoints: ≥12- and ≥16-week RBC-TI response rate

Final analysis will be performed when all participants have completed ~12 months of treatment or discontinued

Dose Regimen

Oral route of administration, three times per week

Starting dose of 2.5 mg/kg with potential for stepwise dose titration to a maximum of 3.5 mg/kg

Phase 3 protocol being finalized per FDA feedback received in April 2026

Large market opportunity

Differentiated profile with potentially superior tolerability and convenient dosing and administration

Targeted Phase 3 program could enable an approval in anemia associated with LR-MDS

Granted FDA Orphan designation, which provides 7 years of regulatory exclusivity in the U.S.

Abstract accepted for European Hematology Association (EHA) annual meeting in June 2026

Highly differentiated profile

Substantial unmet need in LR-MDS anemia

Significant unmet need despite recent approvals

Opportunity for new therapeutic agents that are more effective in RS- patients

No other oral treatments for anemia of LR-MDS commercially available or in late-stage development

Worldwide LR-MDS market is expected to exceed $4B in 5 years

Attractive pricing opportunity combined with efficient commercial model

Potential for >$500M in peak U.S. sales

Thank You

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Disclaimer

Kyntra Bio Inc. published this content on May 11, 2026, and is solely responsible for the information contained herein. Distributed via Public Technologies (PUBT), unedited and unaltered, on May 11, 2026 at 20:14 UTC.