Recent Updates
Recently added Catalysts
EQ

Safe 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-lo

Key Takeaway: EQUALISE Interim Data Type B: Lupus Nephritis Patients 27 September 2022 Exhibit 99.1 Safe Harbor Statement This presentation contains forward-looking statements about Equillium, Inc. (the "Company"). Statements contained in this presentation regarding matters that are not his

Full Press Release Details

EQUALISE Interim Data Type B: Lupus
Nephritis Patients 27 September 2022 Exhibit 99.1
Safe 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.
Additional 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.
Lupus Nephritis: The disease and
50% Of systemic lupus erythematosus
patients will develop lupus nephritis, the most common severe manifestation of the disease 100,000 Lupus nephritis patients in the U.S. 10-30% Of patients will progress to end-stage renal disease requiring kidney replacement therapy < 50%
Of patients achieve a partial response (> 50% reduction in UPCR) after 6 months on standard of care 2 Approved treatments to improve standard induction therapy 60% 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 Lupus Nephritis in Numbers 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
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 Proteinuria/Albuminuria: Surrogate Markers for Renal
Survival 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
Treatment 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 Fanouriakis A, et al., Ann Rheum Dis., 2020; Eular/ERA-EDTA European League Against Rheumatism/European Renal Association-European Dialysis and Transplant Association EULAR/ERA-EDTA 2019 LN
Guidelines Target proteinuria decrease of: Reduce steroids to: by 3 months Partial clinical response by 6 months Complete clinical response by 12 months by 3 to 6 months At least 25% At least 50% UPCR below 0.5- 0.7 g/g < 7.5 mg/day
Response 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 Week 12 ORR 29% 23% 20% 57% ORR 43% 28% 23% 49% ORR 51% Week 26 Week 52
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 Complete Response: < 0.5 g/g Partial Response:
> 50% reduction UPCR No Response: < 50% reduction or worsening UPCR 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 13% 16% 71% Response rates at 12, 26 and 52 weeks
Approved 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 Baseline UPCR Mean (SD) 32% 38% 30% 20% 30% 50% 41% 29%
30% 23% 29% 48% Placebo 6mo 12mo ORR 70% ORR 52% ORR 50% ORR 70% Drug 20% 17% 63% 30% 18% 52% ORR 37% ORR 48% 6mo 12mo Placebo 24mo Drug 24mo 4.1 (2.7) 3.9 (2.4) 3.5 (3.6) 3.2 (2.7) 1. Rovin et al., The Lancet, 2021; 2. Furie et al., NEJM, 2020
Complete Response: < 0.5 g/g Partial Response: > 50% reduction UPCR No Response: < 50% reduction or worsening UPCR 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
Itolizumab: Targeting the CD6-ALCAM
Pathway In Lupus Nephritis
CD6-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 T eff T reg CD6high High Proliferation Pathogenic Phenotypes Pro-inflammatory cytokines CD6low/- Low proliferation
Regulatory phenotype Anti-inflammatory cytokines Consuegra-Fernandez et al., Cell Mol Immunol 2018; Ma et al.,
Bench to Bedside: The CD6-ALCAM
Pathway In Lupus Nephritis Exploratory analysis of SLE patients in Type A portion of the EQUALISE study, with elevated UPCR & UACR, showed an improvement with treatment4 Blockade of CD6 shown to be efficacious in multiple pre-clinical models of
SLE/LN1 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 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 Pre-clinical Translational Clinical
A 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 Restoration of immune regulation
without broad immunosuppression Inhibition of Teff trafficking into renal tissues Synergistic inhibition of multiple Teff cells and cytokines* Treg Teff Teff Teff Teff Teff Teff * including but not limited to IFN- , TNF- , IL-4, IL-5,
IL-6, IL-13 and IL-17
Summary of Type A - SLE
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 Type A
Patients with active or inactive SLE without known lupus nephritis 2 doses itolizumab SC, Days 1 & 15 N = 35 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 EQUALISE Study
Design: Type A - Systemic Lupus Erythematosus (without Lupus Nephritis) Phase 1b open-label, dose escalation study Abbreviations: PK pharmacokinetics, PD pharmacodynamics, SC subcutaneous, SLE systemic lupus erythematosus, Putterman et al., PO1623
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 Itolizumab was generally well tolerated across all subjects and dose groups (n=35) Safety Data Summary: Type A
Cohorts 1 - 5 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
Dose-Dependent Pharmacokinetics
& Rapid Pharmacodynamics *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 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 PHARMACOKINETICS PHARMACODYNAMICS Dose-dependent increases in itolizumab
exposures observed Preliminary data suggest no impact of ADA on PK* Reductions in surface levels of CD6 on CD4 cells observed** Magnitude of decrease is comparable at 1.6 mg/kg and higher
Exploratory 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 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 Itolizumab N=5 N=6 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) Belimumab median % reduction in elevated proteinuria in SLE patients2 (baseline UPCR > 0.2 g/g) Dosing days Belimumab median reduction in UPCR of 38% at week 522 Itolizumab median reduction in UPCR of 43% at week 81
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 Conclusions from
Type A portion of EQUALISE Study Putterman et al., PO1623 & PO1624 ASN, 2021
Interim Data Type B - LN
Last updated: Sep 27, 2022