Equillium Results Presentation Deck

Made public by

Equillium

sourced by PitchSend

21 of 34

Creator

equillium

Category

Healthcare

Published

September 2022

Slides

Transcriptions

#1equillium EQUALISE Interim Data Type B: Lupus Nephritis Patients 27 September 2022 Exhibit 99.1#2Safe Harbor Statement This presentation contains forward-looking statements about Equillium, Inc. (the "Company"). Statements contained in this presentation regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as "anticipate", "believe", "could", "continue", "expect", "estimate", "may", "plan", "outlook", "future" and "project" and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Because such statements are subject to risks and uncertainties, many of which are outside of the Company's control, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to statements regarding the current expectations, estimates, forecasts and projections of Equillium; the potential benefit of treating patients with lupus/lupus nephritis with itolizumab, Equillium's plans and expected timing for developing itolizumab including the expected timing of initiating, completing and announcing further results from the EQUALISE study, the potential for any of Equillium's ongoing or planned clinical studies to show safety or efficacy, and Equillium's plans and expected timing for developing its product candidates and potential benefits of its product candidates. Risks that contribute to the uncertain nature of the forward-looking statements include: the risk that interim results of a clinical study do not necessarily predict final results and that one or more of the clinical outcomes may materially change as patient enrollment continues, following more comprehensive reviews of the data, and as more patient data become available; uncertainties related to the abilities of the leadership team to perform as expected; Equillium's ability to execute its plans and strategies; risks related to performing clinical studies potential delays in the commencement, enrollment and completion of clinical studies and the reporting of data therefrom; the risk that studies will not be completed as planned; Equillium's plans and product development, including the initiation and completion of clinical studies and the reporting of data therefrom; whether the results from clinical studies will validate and support the safety and efficacy of Equillium's product candidates; changes in the competitive landscape; uncertainties related to Equillium's capital requirements; having to use cash in ways or on timing other than expected and the impact of market volatility on cash reserves; and economic, business, competitive, and/or regulatory factors affecting the business of Equillium generally. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and "Management's Discussion and Analysis of financial Condition and Results of Operations" sections of the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, its Current Reports on Form 8-K and other and SEC filings and reports, which may be accessed for free by visiting EDGAR on the SEC web site at http://www.sec.gov and on Equillium's website under the heading "Investors." Investors should take such risks into account and should not rely on forward-looking statements when making investment decisions. All forward-looking statements contained in this presentation speak only as of the date on which they were made. Equillium undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. equillium 2#3Additional Information Where You Can Find Additional Information Related to the Metacrine Transaction This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval with respect to the proposed merger or otherwise. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended. In connection with Equillium, Inc.'s ("Equillium," "the Company," "we," "us," or "our") pending acquisition of Metacrine, Inc. ("Metacrine"), we will file a registration statement on Form S-4 containing a joint proxy statement/prospectus of the Company and Metacrine and other documents concerning the proposed Merger with the Securities and Exchange Commission (the "SEC"). WE URGE INVESTORS TO READ THE JOINT PROXY STATEMENT/PROSPECTUS AND THESE OTHER MATERIALS CAREFULLY WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT US, METACRINE AND THE PROPOSED MERGER. Investors may obtain free copies of the joint proxy statement/prospectus (when available) and other documents filed by us and Metacrine with the SEC at the SEC's website at www.sec.gov. Free copies of the joint proxy statement/prospectus (when available) and our other SEC filings are also available on our website at http://www.equilliumbio.com/. The Company, Metacrine and their respective directors, executive officers, certain members of management and certain employees may be deemed, under SEC rules, to be participants in the solicitation of proxies with respect to the proposed merger. Information regarding our officers and directors is included in our Definitive Proxy Statement on Schedule 14A filed with the SEC on April 13, 2022 with respect to its 2022 Annual Meeting of Stockholders. Information regarding Metacrine's officers and directors is included in Metacrine's Definitive Proxy Statement on Schedule 14A filed with the SEC on April 7, 2022 with respect to its 2022 Annual Meeting of Stockholders. This document is available free of charge at the SEC's website at www.sec.gov or by going to Metacrine's Investors page on its corporate website at www.metacrine.com. This document is available free of charge at the SEC's website at www.sec.gov or by going to our Investors page on its corporate website at www.equilliumbio.com. Additional information regarding the persons who may, under the rules of the SEC, be deemed participants in the solicitation of proxies in connection with the proposed Merger, and a description of their direct and indirect interests in the proposed Merger, which may differ from the interests of our or Metacrine's stockholders generally, will be set forth in the joint proxy statement/prospectus when it is filed with the SEC. equillium 3#4Lupus Nephritis: The disease and treatment goals equillium#5Lupus Nephritis in Numbers equillium 50% 100,000 10-30% < 50% 2 60% Of systemic lupus erythematosus patients will develop lupus nephritis, the most common severe manifestation of the disease Lupus nephritis patients in the U.S. Of patients will progress to end-stage renal disease requiring kidney replacement therapy Of patients achieve a partial response (> 50% reduction in UPCR) after 6 months on standard of care Approved treatments to improve standard induction therapy Of patients fail to achieve a complete response as defined by a UPCR of <0.5 0.7 g/g at 1 year despite new drug approvals Parikh et al., Am J Kid Dis., 2020; Izmirly et al., Arthritis Rheumatol 2021; Rovin et al., The Lancet, 2021; Furie et al., NEJM, 2020 5#6Proteinuria/Albuminuria: Surrogate Markers for Renal Survival Proteinuria/Albuminuria cause renal damage and fibrosis and are markers of disease activity Early, rapid and deep reductions in proteinuria minimize kidney damage and are predictive of better renal outcomes Goal of treatment is to minimize kidney damage and progression to renal failure, preventing the need for renal replacement therapy • Reduction of proteinuria is used by regulatory authorities for approval of new glomerulonephritis therapies, including in lupus nephritis equillium Prognosis of CKD by GFR and Albuminuria Categories: KDIGO 2012 GFR categories (ml/min/1.73 m²) Description and range G1 G2 G3a G3b G4 G5 Normal or high Mildly decreased Mildly to moderately decreased Moderately to severely decreased Severely decreased Kidney failure 290 60-89 45-59 30-44 15-29 <15 Persistent albuminuria categories Description and range A1 Normal to mildly increased <30 mg/g <3 mg/mmol A2 Moderately increased 30-300 mg/g 3-30 mg/mmol A3 Severely increased >300 mg/g >30 mg/mmol Rovin et al. Kidney International, 2021, Levey et al AJKD, 2020, Rovin et al., The Lancet, 2021; Furie et al., NEJM, 2020; KDIGO (Kidney Disease Improving Global Outcomes) 2012 guidelines CKD evaluation and management#7Treatment Goals for Lupus Nephritis The goal of therapeutic intervention is to rapidly and deeply reduce urine protein creatinine ratio (UPCR) and reduce steroid administration, noting that patients in the nephrotic range (> 3-3.5 g/d) may take an additional 6-12 months to achieve desired outcomes, due to slower proteinuria recovery equillium Target proteinuria decrease of: At least 25% EULAR/ERA-EDTA 2019 LN Guidelines by 3 months At least 50% Partial clinical response by 6 months UPCR below 0.5- 0.7 g/g Complete clinical response by 12 months Reduce steroids to: <7.5 mg/day by 3 to 6 months Fanouriakis A, et al., Ann Rheum Dis., 2020: Eular/ERA-EDTA European League Against Rheumatism/European Renal Association-European Dialysis and Transplant Association 7#8Response to Standard of Care Induction Therapy Longitudinal Patterns of Response to Standard of Care Therapy for Lupus Nephritis: Data from the Accelerating Medicines Partnership® (AMP) Lupus Network Response rates at 12, 26 and 52 weeks 13% 16% 71% Week 12 equillium ORR 29% 23% 20% 57% ORR 43% 28% 23% 49% Week 26 Complete Response: < 0.5 g/g Partial Response: > 50% reduction UPCR No Response: < 50% reduction or worsening UPCR Week 52 ORR 51% AMP is a public-private partnership between the NIH, the FDA, pharma and non-profit organizations The AMP Lupus Nephritis Cohort • Cross-sectional and longitudinal analyses of responses of 121 patients with lupus nephritis lupus nephritis (~ mean UPCR 3.2) on SoC at 12, 26 and 52 weeks ● Patients with LN undergoing kidney biopsy as part of standard of care with baseline UPCR > 1.0 g/g The data is representative of a US multicenter multi- ethnic, real-world experience and consistent with placebo group in recently conducted clinical trials Abbreviations: SoC Standard of Care: ORR: overall response rate; ; UPCR: urine protein creatinine ratio Izmirly et al., Arthritis Rheumatol. 2021; Carlucci et al., Arthritis Rheumatol. 2020 00#9Approved Therapies: Need Remains for Rapid & Deep Responses Despite recent approvals, high unmet medical need remains for therapies that induce rapid and deep responses in more patients safely, without broad immuno-suppression ORR 50% Baseline UPCR Mean (SD) 20% 30% 50% 23% 29% 48% 6mo 12mo Placebo 3.9 (2.4) ORR 52% ORR 70% > Lupkynis (voclosporin) 1. Rovin et al., The Lancet, 2021; 2. Furie et al., NEJM, 2020 32% 38% 30% 6mo Drug capsules 41% 29% 30% 12mo 4.1 (2.7) ORR 70% Data from the Phase 3 AURORA-1¹ and BLISS-LN2 trials. Note FDA approved Benlysta on primary efficacy renal response (PERR) defined as UPCR <0.7 g/g.¹ equillium ORR 37% 20% 17% 63% 24mo Placebo 3.5 (3.6) Benlysta (belimumab) 30% 18% 52% 24mo Drug 3.2 (2.7) ORR 48% Complete Response: < 0.5 g/g Partial Response: > 50% reduction UPCR No Response: < 50% reduction or worsening UPCR a#10Itolizumab: Targeting the CD6-ALCAM Pathway In Lupus Nephritis equillium 10#11CD6-ALCAM Pathway is Central to Immuno-inflammation The CD6-ALCAM pathway modulates T cell activity and trafficking and we believe is central to the pathogenesis of multiple immuno-inflammatory diseases • CD6 is a co-stimulatory receptor overexpressed on Teff and down-regulated on Treg CD6High cells exhibit greater pathogenic capacity • Activated leukocyte cell adhesion molecule (ALCAM), is expressed on both antigen-presenting cells and tissues including the blood-brain-barrier, skin, gut, lung and kidney The binding of CD6-ALCAM is important for: • Immune synapse formation Optimal co-stimulation and activation of T cells Trafficking into tissues 0 equillium Consuegra-Fernandez et al., Cell Mol Immunol 2018; Ma et al., T eff Treg . ● CD 6 high High Proliferation Pathogenic Phenotypes Pro-inflammatory cytokines CD6low/- Low proliferation Regulatory phenotype Anti-inflammatory cytokines 11#12Bench to Bedside: The CD6-ALCAM Pathway In Lupus Nephritis Pre-clinical Blockade of CD6 shown to be efficacious in multiple pre-clinical models of SLE/LN1 Translational Antigen specific, autoreactive CD6+ T cells key to SLE/LN pathogenesis² Single cell RNAseq data of LN kidneys versus normal showed a: 16x increase in infiltrating CD6+ T cells 9x increase in ALCAM expression on renal tissues¹ Urinary ALCAM a biomarker of active disease³ Clinical Exploratory analysis of SLE patients in Type A portion of the EQUALISE study, with elevated UPCR & UACR, showed an improvement with treatment4 equillium MRL/1pr: % Survival 100- Urine ALCAM (pg/mg) 50- Ln (normalized expression) 0- H 10 20000 KEpithelial Control isotype anti-mCD6 cyclophos. MMF naive (MPJ) 15 Active LN CD6 K.Epithelial SLE K.Leukocyte Control 20 Age (Weeks) K.Leukocyte SLE U.Leukocyte.SLE Active Non Renal 25 K.Epithelial Control ALCAM 打南部 K.Epithelial. SLE K.Leukocyte.Control Inactive SLE **** KLeukocyte.SLE ** 17.5. 30 U.Leukocyte SLE Healthy Control JCI 2022 Vol 132 jolarg The Journal of Clinical Investigation Contribution of CD6/ALCAM interactions in lupus nephritis nature REVIEWS NEPHROLOGY UPCR, urine protein creatinine ratio: UACR, urine albumin creatinine ratio 1. Chalmers et al., Journal of Clinical Investigation, 2022: 2. Abdirama et al., Clinical Investigation, 2021; 3. Parodis et al., Rheumatology, 2020; 4. Putterman et al., PO1624 ASN, 2021 12#13A Differentiated Approach to Treating Lupus Nephritis A unique, upstream, disease modifying mechanism selectively targeting auto-reactive Teff cell activity and trafficking to promote immune homeostasis and induce durable disease remission Synergistic inhibition of multiple Teff cells and cytokines* equillium Teff Teff Teff Teff Inhibition of Teff trafficking into renal tissues Teff * including but not limited to IFN-y, TNF-a, IL-4, IL-5, IL-6, IL-13 and IL-17 CHO Restoration of immune regulation without broad immunosuppression Treg Teff 13#14equalise Summary of Type A - SLE Patients equillium 14#15EQUALISE Study Design: Type A - Systemic Lupus Erythematosus (without Lupus Nephritis) equalise Phase 1b open-label, dose escalation study Type A Patients with active or inactive SLE without known lupus nephritis 2 doses itolizumab SC, Days 1 & 15 N = 35 equillium Cohort 1: 0.4 mg/kg Cohort 2: 0.8 mg/kg Cohort 3: 1.6 mg/kg Cohort 4: 2.4 mg/kg Cohort 5: 3.2 mg/kg Type A Completed Primary Objective • Assess the safety and tolerability of itolizumab in subjects with systemic lupus erythematosus (SLE) with and without active proliferative lupus nephritis Secondary Objective • Characterize the pharmacokinetics (PK) and pharmacodynamics (PD) of itolizumab Abbreviations: PK pharmacokinetics, PD pharmacodynamics, SC subcutaneous, SLE systemic lupus erythematosus, Putterman et al., PO1623 ASN, 2021 15#16Safety Data Summary: Type A Cohorts 1-5 Itolizumab was generally well tolerated across all subjects and dose groups (n=35) Safety Overview Safety monitored by independent Data Review Committee 49% of subjects experienced at least one adverse event Mostly in the highest dose cohort where multiple injections were required per dose (89% of subjects in 3.2 mg/kg group) Most common terms headache and injection site reaction (erythema/pruritus), predominantly in the 3.2 mg/kg group No deaths • • • 2 SAEs in 1 subject (3.2 mg/kg) unrelated to study treatment, > 30 days after last dose 1 dose limiting toxicity: Grade 3 lymphopenia (2.4 mg/kg) Based on this safety profile, in conjunction with PK/PD data, 1.6 mg/kg selected for Type B subjects to be dosed bi-weekly for 24 weeks equillium Interim data from 19 AUG 2021: final completion of Type A cohort Abbreviations: PD, Pharmacodynamic: PK, Pharmacodynamic SAE, Serious adverse event Putterman et al., PO1623 ASN, 2021 16#17Dose-Dependent Pharmacokinetics & Rapid Pharmacodynamics • PHARMACOKINETICS Dose-dependent increases in itolizumab exposures observed Preliminary data suggest no impact of ADA on PK* equillium Mean +/- SD itolizumab concentration (ng/mL) 10000- 100 15 43 29 Time after first dose 57 Dose (mg/kg) 0.4 0.8 1.6 2.4 3.2 % CD6 of baseline PHARMACODYNAMICS Reductions in surface levels of CD6 on CD4 cells observed** Magnitude of decrease is comparable at 1.6 mg/kg and higher 150 100- 50- 0. 0.4 Day 15 Pre 2nd dose 0.8 1.6 2.4 3.2 Dose (mg/kg) % CD6 of baseline 150 100 50- 0 "Baseline ADA only: 4/19 (21%): low titer (200) ADA observed in 3/19 (16%), at 2 (n=1) and 6 (n=2) weeks after the last dose of study drug "Some missing data points due to inadequate sample collection Day 29 14 days post-2nd dose ** in 0.4 0.8 1.6 2.4 3.2 Dose (mg/kg) Abbreviations: ADA anti-drug antibodies, PK pharmacokinetics, SD standard deviation. Interim data from 19 AUG 2021: final completion of Type A cohort Putterman et al., PO1623 ASN, 2021 ***p<0.001 ** p<0.01 *p<0.05 17#18Exploratory Analysis of SLE Subjects with Elevated Proteinuria Low grade proteinuria is both present and treatable in patients with SLE and provides positive signal of drug activity for the treatment of lupus nephritis Fold Change in UPCR or ACR Itolizumab mean fold change in elevated proteinuria in SLE patients¹ (baseline UPCR > 0.2 g/g, n=6; or ACR> 0.03 g/g, n=4) 1.0 Os equillium Baseline Day 29 Day 57 N 6 6 5 Spot UPCR Change from Mean (n/a) 0.49 Baseline (3) NA į Dosing days I +42 N 4 2 4 ACR Change from Meon (g/n) Baseline (25) 0.39 0.17 Study Day Fold Change in Unne Protein Create Rato -54 43 Fold Change in Urine AlbumCreate a 4 Median % Change Belimumab median % reduction in elevated proteinuria in SLE patients² (baseline UPCR > 0.2 g/g) -Belimumab 1 mg/kg, n=202 Belimumab 10 mg/kg, n=228 0 -10 -20 -30 -40 -50 Placebo, n=215 0 N=6 4 N=5 Itolizumab 8 12 # 16 20 24 28 32 36 40 44 48 52 Weeks Belimumab median reduction in UPCR of 38% at week 52² Itolizumab median reduction in UPCR of 43% at week 8¹ Abbreviations: ACR urine albumin-to-creatinine ratio, UPCR urine protein-to-creatinine ratio, SE standard error, Interim data from 30 July 2021. Change from baseline = (geometric mean of subject specific fold changes from baseline -1) x 100, Data are not available for all subjects at all timepoints. 1. Putterman et al., PO1624 ASN., 2021; 2. Dooley et al., Lupus, 2013, itolizumab data represented for illustrative purposes 18#19Conclusions from Type A portion of EQUALISE Study ✓ Subcutaneous administration of itolizumab (0.4 - 2.4 mg/kg doses) was well tolerated Reduced tolerability was observed at the 3.2 mg/kg dose with over 50% of patients discontinuing treatment after the first dose, 2-3 injections per dose were required ✓ Consistent with the mechanism of action of itolizumab, CD6 on the surface of T cells decreased significantly in a dose dependent fashion with maximal effect achieved at doses of 1.6 mg/kg or higher Exploratory subgroup analysis of Type A SLE subjects with elevated baseline levels of proteinuria or albuminuria (without diagnosis of active lupus nephritis) showed a decline in proteinuria - up to 54% - at two months following two doses of itolizumab ✓ The pharmacokinetic and pharmacodynamic analyses and the safety profile observed to date supports continued evaluation of subcutaneous itolizumab in SLE/ LN (NCT04128579) and other chronic autoimmune diseases equillium Putterman et al., PO1623 & PO1624 ASN, 2021 19#20equalise Interim Data Type B - LN Patients equillium 20#21EQUALISE Study Design: Type B - Lupus Nephritis equalise Type B apLN Patients 1) requiring induction treatment due to new diagnoses or relapsing disease; or 2) incomplete responders to standard of care equillium Itolizumab 1.6 mg/kg SC Q2W 13 doses (Weeks 1-24) Week 28 Clinical activity assessments Week 36 Follow up N = up to 20 Key Eligibility Criteria Mycophenolate 2-3 g/day induction patients may receive pulse systemic corticosteroids but taper to < 10 mg/d by Week 10 Renal biopsy < 12 months ISN/RPS Class III or IV, concomitant Class V permitted > 1.0 g/g proteinuria Primary Objective Assess safety and tolerability . Secondary Objectives • Characterize pharmacokinetics (PK) and pharmacodynamics (PD) • Assess clinical activity: A in UPCR • Proportion of subjects with CR/PR in apLN ▪ A in daily and cumulative prednisone dose ▪ A in serologic markers and eGFR A in SLEDAI-2K ■ Abbreviations: ACR urine albumin-to-creatinine ratio, apLN active proliferative lupus nephritis; CR complete response; eGFR estimated glomerular filtration rate: ISN/RPS class International Society of Nephrology /Renal Pathology Society class: PR partial response, UPCR urine protein-to-creatinine ratio, SC subcutaneous; SLEDAI-2K Systemic Lupus Erythematosus Disease Activity Index 2000: Q2W every 2 weeks 21#22Key Demographics equillium Baseline Characteristics Age: Mean (SD) / Range Female: n (%) Race: n (%) Country: n (%) SLE Duration (years): Mean (SD) / Range LN Duration (years): Mean (SD) / Range History of previous induction treatments: n (%) LN class type: Class III only Class IV only Class III + V Class IV + V UPCR (g/g) (based on 24-hour urine collection ¹.2): Mean (SD) Median (Range) eGFR2 (ml/min/1.73 m²): Mean (SD) / Range Safety Population (n=13) 33.7 (11.8) / 20-58 Female 12 (92%) White: 1 (8%) / Asian: 12 (92%) US: 3 (23%) / India: 10 (77%) 7.3 (7.5) / 1-29 6.0 (6.6) / 0.1-23 9 (69%) 1 (8%) 3 (23%) 3 (23%) 6 (46%) 5.8 (4.3) 5.0 (1.1- 16.5) 110.5 (29) / 50 - 139 UPCR measured by spot collections were highly correlated to 24-hour collection, r> 0.9. Based on a mean of 2 values where available Based on interim data from 2 Sep 2022-subject to change Abbreviations: SLE systemic lupus erythematosus, eGFR estimated glomerular filtration rate: LN lupus nephritis: SD standard deviation: US United States 22#23EQUALISE Type B Summary: 13 subjects dosed Database cut on September 2, 2022, analysis includes: 13 subjects enrolled and dosed (Safety Population) 12 subjects have received > 1 dose and a post-baseline assessment (Efficacy Population) 1 subject discontinued without a post-baseline efficacy assessment due to unrelated adverse event after 1 dose ● · 10 6 subjects assessed at 28 weeks / EOS @ 11 subjects assessed at 12 weeks Patients are highly proteinuric: baseline UPCR mean of 5.8 g/g Range 1.1 to 16.5 g/g equillium Based on interim data from 2 Sep 2022-subject to change: Abbreviations: UPCR urine protein creatinine ratio; EOS end of study: hr hour 23#24Interim Safety Data Summary - Type B Itolizumab was generally safe and well tolerated across all subjects (n=13) Safety Overview 77% of subjects reported at least one adverse event- predominantly mild to moderate in severity 2 subjects (15%) with AESI (lymphopenia) reported 2 subjects (15%) with at least 1 SAE (all SAEs unrelated to study treatment) Early termination of 3 subjects; 2 due to TEAE unrelated fo study treatment and 1 due to physician decision No deaths equillium ☐ Drug Discontinuation (not drug related) Two subjects experienced TEAES that led to discontinuation: Fever and COVID-19 (-D12) Elevated LFT (D54) • One subject withdrew due to physician decision, need for additional therapy Serious Adverse Events (not drug related) Dehydration (D39) COVID-19/Sepsis/Cellulitis/ Renal Impairment/Arthritis bacterial/Diffuse alveolar damage/Myocarditis (first event D12) TEAES of Special Interest (drug related) Two subjects with Grade 3 or 4 lymphopenia ✔ * One subject reduced dose per protocol due to lymphopenia Known PD effect of itolizumab Based on interim data from 2 Sep 2022-subject to change; Abbreviations: AESI adverse event of special interest:: PD: pharmacodynamic: SAE: Serious adverse event; TEAE: treatment emergent adverse event: LFT liver function test 24#25Assessment of PK/PD and Anti-Drug Antibodies • PK profile at 1.6 mg/kg comparable between Type A and B patients ● Reduction of cell surface CD6 (PD marker) is consistent with the mechanism of action • To date, no subjects exhibited high titers of ADA, no changes to PK in ADA positive subjects equillium Mean +/- SD itolizumab concentration (ng/mL) 10000- 100- PK similar between Type A and B subjects Based on interim data from 2 Sep 2022-subject to change: Putterman et al., PO1623, ASN 2021 Abbreviations: ADA: anti-drug antibody: PD: pharmacodynamic: PK: Pharmacokinetic 15 Study day Type A 0.4 mg/kg Type A 0.8 mg/kg Type A 1.6 mg/kg Type A 2.4 mg/kg Type A 3.2 mg/kg Type B 1.6 mg/kg 29 25#26Clinical Responses at 12 & 28 Weeks ORR: 45% equillium 18% 27% 56% Week 12 (n=11) ORR: 83% 17% 33% 33% 17% Week 28/EOS (n=6) ORR: 67% 17% 25% 25% 33% Best response (n=12) Greater ORR achieved by 12 and 28 weeks than is expected with standard of care alone Legend Complete Response: > 50% UPCR reduction and < 0.5 g/g Complete Response: > 50% UPCR reduction and 0.5-0.7 g/g Partial Response: > 50% reduction UPCR No Response: <50% reduction or worsening UPCR Best response shown for all subjects dosed with > 1 dose; UPCR based on spot urine collection Based on interim data from 2 Sep 2022-subject to change. Abbreviations: CR: complete response: EOS: end of study: NR no response: ORR: overall response rate= CR + PR: PR: Partial response; UPCR: urine protein creatinine ratio 26#27Subject #: Baseline UPCR Longitudinal Disposition (n=13) Sub. 1: 2.6 g/g Sub. 2: 3.9 g/g Sub. 3: 10.8 g/g Sub. 5: 8.1 g/g Sub 6: 4.0 g/g Sub. 4: 3.2 g/g Sub. 8: 1.6 g/g Sub. 7: 5.8 g/g Sub. 9: 3.4 g/g Sub. 11 0.5 g/g Sub. 12: 18.3 g/g Sub. 13: 1.7 g/g Sub. 10: 5.4 g/g equillium 8 12 16 20 1 | 28 24 Last dose Follow-up 32 Weeks Based on interim data from 20 Sep 2022-subject to change; End of study denotes completion of follow up visits: Subject 10 without post-baseline efficacy assessments 36 Early, rapid, deep responses Legend First noted Complete Response = > 50% reduction in UPCR and < 0.5 g/g First noted Complete Response ≥ 50% reduction in UPCR and 0.5-0.7 g/g First noted Partial Response = > 50% reduction in UPCR End of Treatment Ongoing End of Study = 27#28Change in UPCR and Best Clinical Response by Subject Legend Complete Response: > 50% UPCR reduction and < 0.5 g/g Complete Response: > 50% UPCR reduction and 0.5-0.7 g/g Partial Response: > 50% reduction UPCR No Response: < 50% reduction or worsening UPCR Maximum Reduction in UPCR (%) equillium 100 90 80 70 60 50 40 30 20 10 0 -10 -20 -30 -40 -50 -60 -70 -80 -90 -100 Sub.1 2.2 g/g Sub.13 Sub.7 1.4 g/g 4.5 g/g Sub.8 0.9 g/g Sub.3 4.6 g/g * Sub.12 6.8 g/g 67% overall response rate Sub.2. 0.9 g/g * Sub.11 0.1 g/g Sub.4 0.5 g/g N = 12 (subjects with > 1 dose and at least 1 post-baseline assessment) * Subjects still actively dosing Subject number with lowest UPCR achieved to date through study completion (week 36) Sub.2 0.6 g/g Sub.5 0.6 g/g Sub.6 0.2 g/g Based on interim data from 2 Sep 2022-subject to change. Abbreviations: ORR-overall response rate= complete and partial response: UPCR urine protein creatinine ratio 28#29Change in UPCR over time 6- imm 12 10 11 2- 1 1410 2 6 10 12 neg ក-ហ៊ូ. 045 nes nes n43 28 143 32 143 36 Baseline Number of Subjects Median Mean (SD) Week 12 Number of Subjects Median Mean (SD) Week 28/EOS^ Number of Subjects Median Mean (SD) Change in UPCR from Baseline n/a n/a n/a equillium eGFR estimated EOS error: 10 -51.3% -36.7% (49.3%) 6 -59.1% -57.7% (28.0%) Daily Steroid Dose (prednisone equivalents) 10 50.0 mg 46.0 (12.6) mg 9 6.2 mg 10.5 (10.7) mg 16 18 Study Week Arithmetic mean UPCR noted with SE: Figure includes data available at each time point AEOS includes subjects that completed follow up visits: # Steroids recorded at Week 24: Based on interim data from 2 Sep 2022-subject to change: UPCR correlation with ACR r=0.99; eGFRs remained stable during treatment period. 5 5.0 mg" 7.5 (5.7) mg# 29#30Itolizumab added to SoC Shows Clinically Meaningful Benefit EULAR/ERA-EDTA treatment goals for patients with lupus nephritis AMP SOC data2,3 (Mean baseline UPCR -3.4) EULAR/ERA-EDTA Treatment Duration equillium 3 months 6 months 12 months Treatment Goal¹ Reduction in proteinuria at least 25% Partial clinical response 50% reduction in proteinuria Complete clinical response Proteinuria < 0.5 g/g Proteinuria < 0.7 g/g Complete clinical response Proteinuria < 0.5 g/g Proteinuria < 0.7 g/g Not reported 52 of 121 (43%) 28 of 121 (23%) Not reported 34 of 121 (28%) Not reported Abbreviations: EOS, end of study: SoC, Standard of Care Itolizumab based on interim data from 2 Sep 2022-subject to change 1. Fanouriakis A, et al. Ann Rheum Dis. 2020; 2. Izmirly et al., Arthritis Rheumatol. 2021; 3. Carlucci et al., Arthritis Rheumatol. 2020 Itolizumab Interim Analysis (Mean baseline UPCR -5.8) 7 of 11 (64%) by Week 12 5 of 6 (83%) by Week 28/ EOS 2 of 12 (17%) 4 of 12 (33%) Dosing completed at 6 mo 30#31EQUALISE Type B Interim Data Highlights Although highly proteinuric at baseline - mean UPCR 5.8 g/g - 83% of subjects had at least a partial response by week 28 and median time to response of 12 weeks 28 weeks / EOS (n = 6) 5/6 (83%) achieved complete or partial response (ORR) in UPCR by 28 weeks / EOS equillium 4/6 (67%) achieved > 80% reduction in UPCR by 28 weeks / EOS > 1 dose (n = 12) 8/12 (67%) achieved > 50% reduction in UPCR achieving at least partial response Mean proteinuria reduction of > 60% (> 3 g reduction in UPCR) Based on interim data from 2 Sep 2022-subject to change: Note: Urine protein creatinine ratio (UPCR) based on spot collection: Abbreviations: EOS: end of study: ORR overall response rate= Complete response or partial response ; EOS: end of study: UPCR urine protein creatinine ratio 31#32Next Steps Key learnings from EQUALISE Type B lupus nephritis interim data: Itolizumab continues to demonstrate a favorable safety and tolerability profile at 1.6 mg/kg dose through six months of treatment 0 Based on compelling data and KOL feedback, Equillium plans to: Continue enrollment in the EQUALISE study-topline data anticipated mid-2023 Continue analysis of serologies and biomarkers such as soluble ALCAM to response rates Prepare for later stage development that can support product registration • Emerging product profile suggests differentiation in early, rapid, and deep responses in highly proteinuric patients Adds to our conviction in the clinical activity of itolizumab and the potential to be an impactful therapy for patients with severe immuno-inflammatory diseases 10 equillium Based on interim data from 2 Sep 2022-subject to change: Abbreviations: ALCAM activated leukocyte cell adhesion molecule: KOL key opinion leader 32

Download to PowerPoint

Download presentation as an editable powerpoint.

Related

Fiscal 3Q Investor Presentation image

Fiscal 3Q Investor Presentation

Healthcare

FY23 Full-Year Results Presentation image

FY23 Full-Year Results Presentation

Healthcare

Healthcare Network P&L Statement and Expansion Projects image

Healthcare Network P&L Statement and Expansion Projects

Healthcare

Accreditation and Quality Assurance Overview image

Accreditation and Quality Assurance Overview

Healthcare

Investment Highlights image

Investment Highlights

Healthcare

Investor Presentation image

Investor Presentation

Healthcare

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update image

IDEAYA Biosciences Interim IDE397 Phase 1 Clinical Data and Q1 2022 Corporate Update

Healthcare

BioAtla Investor Presentation Deck image

BioAtla Investor Presentation Deck

Healthcare