Kailera Therapeutics, Inc. · NASDAQ:KLRA

Kailera Therapeutics — Technical Presentation (September 2026)

19 slides from Kailera Therapeutics's technical presentation, September 2026

  1. Slide 1: Oral safiglipron versus dapagliflozin in adults with type 2 diabetes on metformin

    Oral safiglipron (HRS-7535) versus dapagliflozin in adults with type 2 diabetes inadequately controlled with metformin OUTSTAND-2 phase 3 trial Dongni Yu, on behalf of the OUTSTAND-2 Study Group Department of Endocrinology, Beijing Hospital; National Center of Gerontology; Institute of Geriatric Med

  2. Slide 2: Disclosures and study support

    Disclosures and study support PRESENTER STUDY SUPPORT Professor Dongni Yu OUTSTAND-2 was sponsored and funded by No conflicts of interest to disclose. Jiangsu Hengrui Pharmaceuticals Co., Ltd. PRINCIPAL INVESTIGATOR The sponsor participated in study design, data collection, analysis, interpretation,

  3. Slide 3: Why compare oral small-molecule GLP-1RA and SGLT2 therapy?

    Why compare oral small-molecule GLP-1RA and SGLT2 therapy? CLINICAL CONTEXT OUTSTAND-2 OBJECTIVE GLP-1 receptor agonists and SGLT2 inhibitors are Evaluate once-daily oral safiglipron (proposed established glucose-lowering options with INN; HRS-7535) 30, 60 and 90 mg versus complementary mechanisms¹˒

  4. Slide 4: OUTSTAND-2: three safiglipron doses versus dapagliflozin

    OUTSTAND-2: three safiglipron doses versus dapagliflozin ▸ Phase 3 trial at 98 sites in China: adults aged 18–75 years with type 2 diabetes inadequately controlled with stable metformin (HbA1c 7.5–11.0%; BMI 19.0–40.0 kg/m²). ▸ Participants were randomized 1:1:1:1 (double-blind, double-dummy) to onc

  5. Slide 5: How to interpret the efficacy analyses

    How to interpret the efficacy analyses 1 PRIMARY ANALYSIS Non-inferiority Efficacy estimand Superiority Treatment-policy estimand 2 FIXED-SEQUENCE TESTING 90 / 60 / 30 mg non-inferiority → 90 / 60 / 30 mg superiority → Key secondary endpoints Sequence stopped at 60 mg superiority (P=0.0789); subsequ

  6. Slide 6: Patient disposition through Week 52

    Patient disposition through Week 52 Screen failures (n=352) Assessed for eligibility Eligibility criteria 327; withdrawal 23; lost to follow-up 1; other 1 (n=1,431) ▼ Entered single-blind run- in (n=1,079) Run-in failures (n=269) Eligibility criteria 236; withdrawal 29; investigator decision 4 ▼ Ran

  7. Slide 7: Baseline characteristics were balanced

    Baseline characteristics were balanced DEMOGRAPHICS AND GLYCAEMIC PROFILE METABOLIC, RENAL AND CARDIOVASCULAR PROFILE Safiglipron Safiglipron Safiglipron Dapagliflozin Safiglipron Safiglipron Safiglipron Dapagliflozin Characteristic Characteristic 30 mg (n=202) 60 mg (n=203) 90 mg (n=203) 10 mg (n=2

  8. Slide 8: Change from baseline in HbA1c at Week 32

    All doses met non-inferiority; 90 mg was superior to dapagliflozin Bars and forest plot show the efficacy estimand. The bottom callout shows the treatment-policy estimand. LS mean change from baseline in HbA1c at week 32 (95% CI) Difference vs dapagliflozin (95% CI), percentage points 0 NI margin +0

  9. Slide 9: Week-32 HbA1c effects were consistent across subgroups

    Week-32 HbA1c effects were consistent across subgroups KEY INTERPRETATION • Effects were generally consistent across the prespecified subgroups. • Baseline HbA1c showed a nominal interaction (P=0.0242). Exploratory analyses; interaction P values were nominal and were not adjusted for multiplicity.

  10. Slide 10: HbA1c target attainment and fasting plasma glucose at Week 32

    HbA1c target attainment and fasting plasma glucose at Week 32 Prespecified key secondary findings; non-confirmatory since testing stopped Fasting plasma glucose Estimated HbA1c target attainment at week 32 LS mean change from baseline at week 32 (mmol/L) Model-estimated proportions under the efficac

  11. Slide 11: Body weight change at Week 32

    Body weight change at Week 32 Prespecified key secondary endpoint; non-confirmatory since testing stopped Difference vs dapagliflozin (95% CI) LS mean percentage change in body weight at week 32 (95% CI) 0 30 mg +1.25 −1 Change from baseline (%) (0.46 to 2.04) −2 60 mg +0.06 −3 −2.35% (−0.75 to 0.86

  12. Slide 12: Changes in HOMA-β and HOMA-IR

    Changes in HOMA-β and HOMA-IR Prespecified supportive endpoints at week 32 Week-32 geometric mean change HOMA-β +76.9% +78.0% +98.5% safiglipron 30 / 60 / 90 mg vs +11.5% with dapagliflozin HOMA-IR −16.0% −18.9% −22.5% vs −38.5% with dapagliflozin HOMA-β increased more with safiglipron HOMA-IR decre

  13. Slide 13: Cardiometabolic and renal markers at Week 32

    Cardiometabolic and renal markers at Week 32 Prespecified exploratory analyses; no adjustment for multiplicity LIPIDS: Percentage change from baseline UACR: Difference vs dapagliflozin safiglipron 90 mg compared with dapagliflozin Dapagliflozin-adjusted percentage difference (95% CI) −10.5% Triglyce

  14. Slide 14: Supportive outcomes: secondary and exploratory endpoints

    Supportive outcomes: secondary and exploratory endpoints Safiglipron Safiglipron Safiglipron Dapagliflozin Outcome 30 mg 60 mg 90 mg 10 mg 7-POINT SMBG AT WEEK 32 (N=202) (N=203) (N=203) (N=202) Baseline (dashed) versus Week 32 (solid) WEEK 52 — SUPPORTIVE EFFICACY HbA1c change, % −1.35 −1.20 −1.43

  15. Slide 15: Overall safety summary through Week 52

    Overall safety summary through Week 52 SAFETY POPULATION | 52-WEEK TREATMENT PERIOD Safiglipron Safiglipron Safiglipron Dapagliflozin Event, n (%) 30 mg (N=202) 60 mg (N=202) 90 mg (N=203) 10 mg (N=202) Any TEAE 188 (93.1) 195 (96.5) 199 (98.0) 188 (93.1) TEAE considered related to study treatment 1

  16. Slide 16: Common treatment-emergent adverse events through Week 52

    Common treatment-emergent adverse events through Week 52 SAFETY POPULATION | 52-WEEK TREATMENT PERIOD Preferred terms reported in ≥10% of participants in any treatment group Safiglipron Safiglipron Safiglipron Dapagliflozin Preferred term, n (%) 30 mg (N=202) 60 mg (N=202) 90 mg (N=203) 10 mg (N=202

  17. Slide 17: Conclusions

    Conclusions PRIMARY ENDPOINT OTHER OUTCOMES SAFETY Primary endpoint met Supportive findings Safety through Week 52 • Safiglipron 30, 60, and 90 mg met • Benefits were observed for • GI events and AE-related the prespecified non-inferiority HbA1c target attainment, FPG, discontinuations were more fre

  18. Slide 18: Acknowledgements

    Acknowledgements We would like to thank the following: – All trial participants and their families. – Investigators and research personnel at the 98 participating study sites across China. – The OUTSTAND-2 Study Group and staff at Jiangsu Hengrui Pharmaceuticals Co., Ltd. – The EASD 2026 Annual Meet

  19. Slide 19: Thank you

    Thank you Questions & discussion OUTSTAND-2 | NCT06589765 Accepted in Nature Medicine (Publication forthcoming)

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