Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

February 26, 2019

Date of Report (Date of earliest event reported)

 

 

Equillium, Inc.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-38692   82-1554746

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

2223 Avenida de la Playa, Suite 108

La Jolla, CA

  92037
(Address of principal executive offices)   (Zip Code)

Registrant’s telephone number, including area code: (858) 412-5302

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:

 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b–2 of the Securities Exchange Act of 1934 (§ 240.12b–2 of this chapter).

Emerging growth company  ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐

 

 

 


Item 2.02

Results of Operations and Financial Condition.

Equillium, Inc. (the “Company”) is holding a business update call on February 26, 2019, which includes certain 2018 financial estimates. The Company estimates that its cash, cash equivalents, and investments as of December 31, 2018 were approximately $65.9 million, which the Company anticipates will enable it to fund its operations for at least the next 24 months.

The Company has not yet completed its year-end close process for the quarter and year ended December 31, 2018 and this estimate is a preliminary estimate of financial and operational results that it expects to report for the applicable period. In addition, the Company’s independent registered public accounting firm, KPMG LLP, has not audited, reviewed or compiled this estimate and, accordingly, does not express an opinion on, nor has it provided any other form of assurance with respect to, this preliminary estimate. This estimate is not a comprehensive statement of the Company’s financial or operational results for the quarter and year ended December 31, 2018 and its actual results may differ materially from this estimate as a result of the completion of the Company’s closing procedures, final adjustments and other developments arising between now and the time that the Company’s financial and operational results for this period are finalized.

The information in this Item 2.02 of this Current Report on Form 8-K is being furnished pursuant to Item 2.02 and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended (the “Securities Act”), or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this item of this report.

 

Item 7.01

Regulation FD Disclosure.

On February 26, 2019, the Company updated its corporate slide presentation for use in meetings with investors, analysts and others. The presentation is available through the Company’s website and a copy is attached as Exhibit 99.1 hereto.

The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished pursuant to Item 7.01 and shall not be deemed “filed” for purposes of Section 18 of the Exchange Act or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this item of this report.

 

Item 8.01

Other Events.

On February 26, 2019, the Company issued a press release announcing certain business updates regarding the Company. A copy of the press release is attached as Exhibit 99.2 hereto and is incorporated by reference herein.

 

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit

   No.   

  

Description

99.1    Slide Presentation dated February 26, 2019
99.2    Press Release dated February 26, 2019


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

  Equillium, Inc.
Dated: February 26, 2019   By:  

/s/ Jason A. Keyes

    Jason A. Keyes
    Chief Financial Officer
EX-99.1

Slide 1

Harnessing Novel  Immunobiology February 2019 Exhibit 99.1


Slide 2

Safe Harbor Statement This presentation contains forward-looking statements about Equillium, Inc. (the “Company”). In some cases, you can identify forward-looking statements by the words “will,” “expect,” “intend,” “plan,” “objective,” “believe,” “estimate,” “potential,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements are based on Company management’s current beliefs and expectations. These statements include but are not limited to statements regarding the Company’s business strategy, the Company’s plans to develop and commercialize its product candidates, the safety and efficacy of the Company’s product candidates, the Company’s plans and expected timing with respect to regulatory filings and approvals, and size and growth potential of the markets for the Company’s product candidates. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. The Company may not actually achieve the plans, intentions or expectations disclosed in its forward-looking statements, and you should not place undue reliance on the Company’s forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed or implied in the forward-looking statements the Company makes due to the risks and uncertainties inherent in the Company’s business, including without limitation, risk described in the Company’s filings with the Securities and Exchange Commission (“SEC”). You are cautioned not to place undue reliance on these forward-looking statements, which represent the Company’s views as of the date of this presentation. The Company’s anticipates that subsequent events and developments will cause the its views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company has no current intention of doing so except to the extent required by applicable law. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in the Company’s filings and reports, which may be accessed for free by visiting EDGAR on the SEC web site at http://www.sec.gov. and on the Company’s website under the heading “Investors.” All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the “safe harbor” provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.


Slide 3

Executive Summary Validated therapeutic: itolizumab has shown clinical efficacy in multiple indications – studied by Biocon in >330 patients – and is approved for the treatment of psoriasis in India Pipeline-in-a-product: EQ001 has broad potential disease modifying therapeutic utility; launching multiple clinical studies during 2019   First-in-class: Equillium is developing EQ001 (itolizumab) the first antibody targeting the novel immune checkpoint pathway CD6 – for the treatment of severe immuno-inflammatory disorders High-value partnership: Equillium acquired exclusive rights to EQ001 for the U.S. & Canada from Biocon – partnership provides clinical & commercial product, commercial scale production at FDA regulated facility Accomplished team: experienced in drug discovery, development and commercialization EQ financing: IPO completed in Q4 2018 – Jefferies, SVB Leerink, Stifel


Slide 4

Recent Accomplishments and Planned Milestones On track to begin Phase 1b study in Asthma in Q2 2019 On track to begin Phase 1b/2 study in aGVHD in March 2019 Acute Graft Versus Host Disease (aGVHD): awarded Fast Track designation and Orphan Drug designations for both prevention and treatment Nominated Lupus Nephritis as additional target indication with plans to initiate Phase 1b study in 2H 2019


Slide 5

Accomplished Management Team Dan Bradbury Chairman & Chief Executive Officer Bruce Steel, CFA President & Chief Business Officer Christine Zedelmayer Vice-President of Operations Steve Connelly, PhD Chief Scientific Officer Jason Keyes Chief Financial Officer David Essayan, MD Head of Regulatory Affairs Krishna Polu, MD Chief Medical Officer Joel Rothman Vice-President of Development Randy Adams Vice-President of Commercial


Slide 6

EQ001 Development Strategy We are leveraging our deep understanding of the CD6 pathway to develop EQ001 for multiple severe immuno-inflammatory disorders aGVHD severe asthma Indication Phase 1 Phase 1b / 2 Phase 3 Expected Milestones IND open FDA Fast Track and ODD lupus nephritis Severe asthma proof-of-concept trial to initiate Q2 2019 Phase 1b/2 aGVHD trial to initiate March 2019 Data to inform further development in GVHD, e.g. GVHD prevention, cGVHD LN proof-of-concept trial to initiate H2 2019 Data to inform further development in lupus, e.g. cutaneous lupus, SLE


Slide 7

CD6 Plays a Central Role in Immuno-inflammation


Slide 8

CD6 Role in Immuno-inflammatory Disease Transplant Science Neuro- Inflammation Systemic Autoimmunity Gastrointestinal Ophthalmic Pulmonary Acute Graft-Versus- Host Disease Chronic Graft-Versus-Host Disease Severe Asthma Interstitial Lung Diseases Lupus/Lupus Nephritis Scleroderma Behcet’s Disease Rheumatoid Arthritis Psoriatic Arthritis Psoriasis Uveitis Ulcerative Colitis Crohn’s Disease Multiple Sclerosis Neuromyelitis Optica Dermatological Solid Organ Rejection Chronic Obstructive Pulmonary Disease Atopic Dermatitis Vasculitis Effector T cells, or Teff, play an important role in the pathogenesis of T cell mediated diseases driving autoimmune and allergic inflammation CD6 is a tightly regulated, co-stimulatory receptor functionally important in modulating the activation, proliferation, differentiation & trafficking of Teff cells


Slide 9

The Basis of Immuno-inflammation Immuno-inflammatory diseases can be fundamentally characterized by an imbalance between effector cell and immuno-regulatory activity Treg Teff Autoimmunity Tolerance Teff Teff Treg Teff


Slide 10

CD6 is Central to Immuno-inflammation Highest levels of CD6 are found on activated T effector cells (Teff) and associated with amplification of the auto-reactive cascade Immune Regulatory “Tolerance” Autoreactive “Autoimmunity”


Slide 11

CD6 Drives Pathogenic T Cell Activity & Trafficking Co-stimulation = Activation Proliferation Differentiation / Survival Trafficking INCREASED PROINFLAMMATORY CYTOKINE SECRETION SUPPRESSION OF REGULATORY PATHWAYS INCREASED TRAFFICKING OF PATHOGENIC T CELLS


Slide 12

EQ001 Inhibits Pathogenic T Cell Activity & Trafficking Inhibition = Activation Proliferation Differentiation / Survival Trafficking RESTORATION OF REGULATORY PATHWAYS DECREASED PROINFLAMMATORY CYTOKINE SECRETION DECREASED TRAFFICKING OF PATHOGENIC T CELLS


Slide 13

Upstream, Disease Modifying Immuno-inflammatory Mechanism Restoration of immune regulation… without immunosuppression Inhibition of trafficking… into key target organs Inhibition of T effector cells… upstream of current approaches EQ001 is designed to selectively target autoreactive effector T cell activity and trafficking, while sparing regulatory T cells to promote immune tolerance and durable disease remission Treg Teff Teff Teff Teff Teff Teff


Slide 14

Clinical Strategy


Slide 15

Itolizumab is Clinically Validated in Autoimmune Disease Phase 3 pivotal trial results: demonstrated efficacy & safety in psoriasis patients (n=223) Baseline 12 Weeks 28 Weeks Efficacious Treatment Arm Dosing Week 0-4 Dosing Week 5-12 PASI 75 Week 12 Dosing Week 12+ 0.4mg/kg QW 1.6mg/kg Q2W 27% (p = 0.0172) 1.6mg/kg Q4W 1.6mg/kg Q2W 1.6mg/kg Q2W 36% (p = 0.0043) 1.6mg/kg Q4W placebo placebo 2.3% 1.6mg/kg Q2W Durable Response At week 28, itolizumab responders (PASI≥75) were re-randomized into 2 groups Drug Withdrawal Group (placebo n = 40) 53% maintained PASI≥75 at 1-year Maintenance Therapy Group (itolizumab1.6mg/kg q12w n = 39) 67% maintained PASI≥75 at 1-year Safe & Tolerable Weeks 1-12 ALZUMAb (n = 180) Placebo (n = 43) Any Adverse Event 72 (40.0%) 20 (46.5%) Infusion Reaction 33 (18.3%) 1 (2.3%) Infection 6 (3.3%) 4 (9.3%) Pruritus 5 (2.8%) 3 (7.0%) Cross over point TREAT-PLAQ – Trial Results


Slide 16

Opportunity in Multiple Severe Autoimmune Indications Therapeutic Area Therapeutic Indication Scientific Rationale Translational Research Commercial Opportunity Clinical Plan Transplant Science aGVHD cGVHD Pulmonary severe asthma Systemic Autoimmunity systemic lupus, lupus nephritis, scleroderma Gastrointestinal Crohn’s colitis Neuroinflammation multiple sclerosis neuromyelitis optica Scientific Rationale Genetic data implicates CD6 Pathogenic CD6+ cells Underlying Treg/ Teff imbalance Target organs express ALCAM known to traffic CD6 cells + Translational Research Bioinformatics Cell-based assays Animal models Human tissue analysis Clinical Development Clear development path Identifiable patient population Potential regulatory incentives KOL support and partnerships with leading centers Clinical design and timeline Commercial Analysis High unmet medical need Steroid insensitive or refractory populations Concentrated treatment base Reimbursement Overall market opportunity Key Selection Criteria EQ001 Opportunity Set


Slide 17

GVHD Remains an Area of High Unmet Medical Need Advanced aGVHD skin Advanced aGVHD Gut Bronchiolitis Obliterans of the Lung in cGVHD aGVHD ~50% of HSCT cGVHD ~30-70% of HSCT Mortality from aGVHD as high as 95% in steroid refractory patients Steroids remain SoC for first-line treatment of aGVHD and cGVHD cGVHD is the leading cause of non-relapse mortality in patients surviving more than 2 years Acute GVHD Chronic GVHD


Slide 18

GVHD is a Significant & Growing Market Opportunity Projected US aGVHD incidence and GVHD prevalence by the year 2025 Annual incidence of aGVHD up to 6,000 Total prevalence of GVHD up to 35,000 Currently, limited available FDA approved therapies Significant need for safe and effective therapies No products approved for aGVHD Ibrutinib approved 2nd/3rd line for cGVHD More than 8,500 allogeneic transplants in 2016 4% annual growth rate since 2007


Slide 19

CD6 Plays a Central Role in GVHD Autoreactive Teff cells drive tissue damage in GVHD Teff cells overexpress CD6 CD6 co-stimulation results in increased Teff cell activation, proliferation and increased secretion of pro-inflammatory cytokines including IFN-γ, TNF-α, IL-6 and IL-17 CD6 co-stimulation increases pSTAT3/RORγt signaling and facilitates Th17 differentiation Th17 cells are steroid resistant and play a critical role in the pathogenesis of GVHD In GVHD patients, studies have shown a high Th17:Treg ratio suggesting a loss of tolerance Teff cells that express CD6, facilitated by ALCAM, infiltrate GVHD target organs Blockade by EQ001 inhibits Teff activation, proliferation, differentiation and trafficking while preserving Treg cells, promoting immune tolerance


Slide 20

EQUATE Study in aGVHD 2:1 Active:Placebo, N ~60 Treatment Frontline therapy within 72 hours of presentation concomitant with steroids Five doses administered Q2W Long term follow-up to 1 year Study Population Patients at first presentation of aGVHD Phase 1b will evaluate high risk patients (adults) enriched for Grade III/IV aGVHD Phase 2 will evaluate Grade II-IV aGVHD; age ≥ 12 Design Phase 1b: Open-label, IV, multi-dose q2w, 3+3 design (minimum 2 cohorts) Phase 1b informs Phase 2 Dose selection Sample size based on event rates Design Phase 2: Randomized, Double-Blind, Placebo Controlled Study Endpoints in Phase 1b and Phase 2 Safety/PK/PD Clinical Activity Overall response rate at 28 and 56 days aGVHD clinical scores Disease relapse and Overall mortality at 12 months Incidence and severity of chronic GVHD Immunogenicity – ADA/nADA Immunoscience – Immunophenotyping, transcriptomics, and inflammatory biomarkers Evaluating the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 N = 9-24 Cohort 1 0.4 mg/kg Cohort 2 0.8 mg/kg Cohort 3 1.6 mg/kg Cohort 4 2.4 mg/kg


Slide 21

Severe Asthma: Significant Need in Severe Refractory Patients Severe Asthma patients are characterized by: Requires treatment with high dose inhaled corticosteroids, systemic corticosteroids or biologics (anti-IgE, anti-IL-5) Also includes patients that remain “uncontrolled” despite this therapy Poor symptom control Frequent severe exacerbations including related hospitalizations Decline in lung function (FEV1) 26 Million Total Asthma Prevalence 5 - 10% of asthma patients have severe disease ~1.3 – 2.6MM 50% of severe asthma patients uncontrolled w/ high-dose LABA / ICS ~650k - 1.3MM 50 - 60% of uncontrolled patients don’t respond to therapies targeting production of IgE or T2 cytokines


Slide 22

CD6 is Upregulated in Severe Asthma Patients Analysis of gene expression datasets support the presence of increased CD6, CD4 T cells, and ALCAM in the lung of severe asthma patients In a separate set of patients, analysis of gene expression in lung tissue suggests higher expression of the CD6 ligand ALCAM within the airway of patients who have died from asthma Analysis of gene expression in cells collected from lungs of healthy non-asthma, moderate asthma and severe asthma patients as part of two multi-center prospective observational studies ***p<0.001, *p<0.05. CD4 expression CD6 expression ALCAM expression


Slide 23

Th17 Cells Expressing CD6 Drive Severe Refractory Asthma Current therapies target downstream signaling of Th2-associated inflammation Current downstream therapies ineffective in patients with low levels of eosinophils No approved therapies EQ001 anti-TSLP anti-IgE anti-IL-5 DP2 Agonist Mepolizumab Severe eosinophilic asthma Reslizumab Severe eosinophilic asthma anti-IL-4 and IL-13 anti-IL-33 Omalizumab Moderate to severe asthma Benralizumab Severe eosinophilic asthma Dupilumab Moderate-severe eosinophilic asthma Fevipiprant Moderate-severe eosinophilic asthma Phase 3 RG6149 / AMG282 Moderate-severe eosinophilic asthma Etokimab Moderate-severe eosinophilic asthma GSK3772847 Moderate-severe eosinophilic asthma Phase 2 Tezepelumab Uncontrolled severe asthma Phase 3 anti-IL-23 Risankizumab Moderate-severe uncontrolled Phase 2 Th2-High Eosinophils Non-Th2 Neutrophils Th2-Low Low Eosinophils Reciprocally regulated Response to steroids


Slide 24

EQUIP Study in Moderate-to-Severe Uncontrolled Asthma Design: Randomized, Double-Blind, placebo controlled, multiple dose, dose escalation study Treatment and Follow-up (12 weeks) EQ001 administered Q2W (SC), weeks 1-8 Final safety, PK/PD, and efficacy assessments at end of week 12 Study Population Moderate to Severe Asthma uncontrolled asthma Prebronchodilator FEV1 ≥40% and ≤90% At least one clinically significant asthma exacerbation in the preceding 12 months Cohorts and Dosing 8 adult subjects each, randomized 3:1 (6 active: 2 placebo) The study will enroll up to 32 subjects in 4 successive cohorts (0.8mg/kg, 1.6 mg/kg, 2.4 mg/kg and 3.2 mg/kg) with opportunity for cohort expansion Study Endpoints Safety/PK/PD Efficacy FEV1 FeNO ACQ6 Rescue inhaler use and exacerbations Blood Eosinophils, IgE Immunogenicity- ADA Translational biology – Immunophenotyping and Inflammatory biomarkers Evaluating the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 Cohort 1 0.8 mg/kg Cohort 2 1.6 mg/kg Cohort 3 2.4 mg/kg Cohort 4 3.2 mg/kg


Slide 25

Significant Unmet Need in Lupus Nephritis Despite SoC, up to 40% of patients with severe proliferative disease will progress to end-stage renal disease (ESRD) Systemic lupus erythematosus (SLE) is a heterogeneous, multisystem, auto-immune disease characterized by the presence of multiple autoantibodies and deposition of immune complexes in various tissues Lupus Nephritis (LN) is the most frequent and serious manifestation, affecting 30-60% of SLE patients As many as 50% - 75% of LN patients are refractory to standard of care treatment; for those that respond the majority will relapse within five years There are >100,000 Lupus Nephritis Patients in the U.S.


Slide 26

Nature Reviews Nephrology T Cells are Central to Immuno-pathogenesis of Lupus Nephritis T cells lie at the center of activation of the adaptive and innate immune system in Lupus Nephritis Innate and adaptive immune response to nuclear histone proteins (e.g. dsDNA) Autoantibodies form and deposit in the glomerulus, renal tubules, and blood vessels of the kidney Adaptive (T cells) and Innate immune cells (macrophages, basophils) recruited to the kidney lead to injury, progressive proteinuria, fibrosis, and renal failure


Slide 27

Supportive preclinical data from mouse models of lupus and glomerulonephritis (GN) Treatment with anti-CD6 mAb shows improvement in disease activity in Lupus model Treatment with anti-CD6 mAbs shows improvement in renal function in GN model Analysis of LN kidney biopsies show upregulation of CD6 in infiltrating T cells and an increase in ALCAM expression in APCs and broadly in resident renal cells Elevations in urinary ALCAM identifies patients with active lupus nephritis Additional translational studies ongoing to expand understanding of anti-CD6 therapy in LN and to profile patient blood and urine biomarkers for soluble CD6 and ALCAM Translational Data Supports Targeting CD6 in Lupus Nephritis


Slide 1

Limited Clinical Pipeline in Lupus Nephritis T cell approaches have demonstrated promising efficacy, but have been discontinued due to safety concerns B cell focused approaches have failed in Lupus Nephritis Lupus is both a B cell and T cell mediated disease Many development programs have been plagued by the heterogeneity of the patient population as well as trial design EQ001 is expected to work by modulating the activation and trafficking of Teff cells without impacting Treg cells 28 Phase I / II Phase III Filed/Registered Marketed Belimumab – GSK BlyS/BAFF Eculizuma - Alexion Complement-5 KZR-616 – Kezar Selective proteasome inhibitor Anifrolumab - AstraZeneca anti IFN-α Obinutuzumab – Genentech Anti-CD20 BI 655064 - Boehringer Ingelheim Anti-CD40 Voclosporin - Aurinia Calcineurin inhibitor APL-2 Apellis C3 Complement Mediator Other B Cells T Cells Cytokine and complement inhibitors Therapeutic Target:


Slide 29

Urinary Biomarkers May Guide Development Plan Leveraging urinary biomarkers can optimize drug development in Lupus Nephritis Address heterogeneity – determine patient response by urinary levels of CD6-ALCAM Optimize Therapeutic Index – urinary biomarkers to optimize dose selection and maximize therapeutic index Efficient Trial Design – Use urinary biomarker assessments to guide efficacy analysis plan and open up optionality for regulatory paths forward A number of therapies have been developed in LN and SLE that have failed. Reasons for failure have included: Trial Design Safety/ Therapeutic Index Heterogeneity of patient population – Differences in Disease Mechanisms by Patient 1 2 3 Biomarkers may help identify the right patient and maximize the benefit-risk for a given therapy and increase probability of successful drug development


Slide 30

Lupus Nephritis Next Steps Expand assessment of CD6-ALCAM pathway urinary biomarkers as part of companion diagnostic strategy We plan to initiate a Phase 1b proof-of-concept study in the second half of 2019 Trial will enroll adults with active proliferative Lupus Nephritis (Class III or IV +/- Class V) Study objectives will include an assessment of PK/PD, dose finding, safety, efficacy, disease biomarkers


Slide 31

Corporate


Slide 32

Partnership with a Leading Global Biopharma Company Leading global biologics manufacturer with FDA regulated cGMP facilities World’s fourth largest insulin producer, and leading bio-similar developer: insulin glargine (Lantus®), adalimumab (Humira®), bevacizumab (Avastin®), etanercept (Enbrel®) Trastuzumab (Herceptin®) & pegfilgrastim (Neulasta®) FDA approved for U.S. market India’s largest fully-integrated biopharma company ~$5 billion market capitalization


Slide 33

: Partnership for U.S. & Canada Equillium exclusive licensee to itolizumab for U.S. & Canada Biocon is a significant minority shareholder in Equillium Biocon partnership provides clinical and commercial supply of our drug product: Biocon has completed CMC & manufactures drug product at commercial scale in FDA regulated facility Drug product for 3 concurrent orphan indications until first U.S. approval at no cost, all other clinical supply at cost Exclusive supplier for commercial product Milestones & royalties: Biocon receives milestones and royalty on Equillium sales Equillium receives royalty on Biocon sales* * Royalty to Equillium on any approved indications leveraging Equillium clinical data


Slide 34

Intellectual Property & Market Exclusivity Patent term Provisional Application (2039) Method of treating severe asthma Pending PCT Application (2037) Method of treating lupus Pending Applications (2030-2034) Formulation patent Method of treating MS (High Th17) Granted US Patents (2028) Molecule’s sequence Method of treating: psoriasis multiple sclerosis rheumatoid arthritis transplant rejection Projected FDA regulatory exclusivity If eligible, would be granted upon U.S. approval Composition of Matter / Method of Treating U.S. Patent No. 8,524,233 Patent term ~ 2028 Orphan Designation -7 years Biologics Exclusivity -12 years Method of Treating Lupus PCT Application Patent term ~ 2037 2005 2015 2025 2035 Method of Treating MS U.S. Patent Application Patent term ~ 2034 Method of Formulating U.S. Patent Application Patent term ~ 2030 2010 2020 2030 2040 Method of Treating Severe Asthma U.S. Provisional Application Patent term ~ 2039


Slide 35

Executive Summary Validated therapeutic: itolizumab has shown clinical efficacy in multiple indications – studied by Biocon in >330 patients – and is approved for the treatment of psoriasis in India Pipeline-in-a-product: EQ001 has broad potential disease modifying therapeutic utility; launching multiple clinical studies during 2019   First-in-class: Equillium is developing EQ001 (itolizumab) the first antibody targeting the novel immune checkpoint pathway CD6 – for the treatment of severe immuno-inflammatory disorders High-value partnership: Equillium acquired exclusive rights to EQ001 for the U.S. & Canada from Biocon – partnership provides clinical & commercial product, commercial scale production at FDA regulated facility Accomplished team: experienced in drug discovery, development and commercialization EQ financing: IPO completed in Q4 2018 – Jefferies, SVB Leerink, Stifel


Slide 36

EQ001 Development Strategy We are leveraging our deep understanding of the CD6 pathway to develop EQ001 for multiple severe immuno-inflammatory disorders aGVHD severe asthma Indication Phase 1 Phase 1b / 2 Phase 3 Expected Milestones IND open FDA Fast Track and ODD lupus nephritis Severe asthma proof-of-concept trial to initiate Q2 2019 Phase 1b/2 aGVHD trial to initiate March 2019 Data to inform further development in GVHD, e.g. GVHD prevention, cGVHD LN proof-of-concept trial to initiate H2 2019 Data to inform further development in lupus, e.g. cutaneous lupus, SLE


Slide 37

Equillium, Inc. 2223 Avenida de la Playa / Suite 108 La Jolla, CA 92037 www.equilliumbio.com

EX-99.2

Exhibit 99.2

 

LOGO

Equillium Announces Plan to Develop EQ001 for the

Treatment of Lupus Nephritis

Clinical trial evaluating EQ001 for the treatment of refractory lupus nephritis

to commence in 2H 2019

Ongoing EQ001 development programs in acute graft-versus-host disease and

severe asthma remain on-track

Company to host conference call today, Tuesday, February 26, at 4:30 p.m. ET

LA JOLLA, Feb. 26, 2019 – Equillium, Inc. (Nasdaq: EQ), a biotechnology company leveraging deep understanding of immunobiology to develop products to treat severe autoimmune and inflammatory disorders with high unmet medical need, today announced that it plans to develop EQ001 for the treatment of lupus nephritis (LN). Equillium remains on track to initiate the EQUATE Phase 1b/2 trial in acute graft-versus-host disease (aGVHD) in the first quarter of 2019 and initiate a proof-of-concept trial in severe asthma in the second quarter of 2019. Equillium will host a conference call today to provide further details.

“Our decision to explore EQ001 for the treatment of lupus nephritis is consistent with our goal of developing promising new therapies that help patients with severe and underserved autoimmune diseases,” said Daniel Bradbury, chairman and chief executive officer of Equillium. “With over 100,000 LN patients in the United States alone and no currently FDA-approved therapies, there is a strong clinical rationale for pursuing this indication. Additionally, we believe EQ001’s unique mechanism of modulating both the activity and trafficking of pathogenic T cells provides a strong scientific rationale and highly differentiated approach to treat this difficult disease.”

LN is a life-threatening complication of systemic lupus erythematosus (SLE) and occurs when the body’s immune system attacks the kidneys. Current standard of care therapies, including prednisone, mycophenolate, and cyclophosphamide, rarely lead to long-term disease remission and can have significant toxicities. As many as 50 to 75 percent of LN patients are refractory to standard of care treatment, and, for those who respond, the majority will relapse within five years. Additionally, 10 to 30 percent of LN patients and up to 40 percent of patients with severe proliferative disease progress to end stage renal disease, necessitating chronic dialysis or transplant.

 

1


LOGO

 

EQ001 blocks the CD6-Activated Leukocyte Cell Adhesion Molecule (ALCAM) pathway thereby inhibiting T cell activation and trafficking into tissues. Equillium believes EQ001 represents a promising therapeutic approach in LN that is highly differentiated relative to B cell, single cytokine and other co-stimulatory therapies that have largely failed in attempts to develop treatments for lupus and LN.

A targeted approach to blocking the CD6-ALCAM pathway is further supported by translational research conducted by Chandra Mohan, M.D., a rheumatologist and Hugh Roy and Lillie Cranz Cullen Endowed Professor of Biomedical Engineering at the University of Houston, who has identified urinary ALCAM in LN patients as a predictive biomarker in detecting patients with active LN. Equillium believes this research, which is supported by a Target Identification in Lupus grant from the Lupus Research Alliance, has important implications in the development of EQ001 in LN, and forms the initial basis for a companion diagnostic strategy that could potentially help identify the patients who are most likely to respond to therapy, monitor disease, and guide treatment.

“Targeting LN is an important expansion of our pipeline that we are accelerating; given the central role that T cells play in LN immunopathogenesis, the CD6-ALCAM pathway represents an attractive and promising target in this indication for EQ001,” said Krishna Polu, M.D., a nephrologist and chief medical officer of Equillium. “By further leveraging and building upon the research conducted by Dr. Mohan, we believe that urinary biomarkers can be used as an efficient and pragmatic tool to study disease pathways and identify LN patients in which the CD6-ALCAM pathway may be a strong driver of the disease. Leveraging urinary biomarkers to guide the development of targeted therapeutics is groundbreaking in this field, and we believe increases the likelihood of getting the right therapies to the right LN patients. We look forward to initiating the LN clinical development program later this year.”

Lupus Research Alliance president and chief executive officer Kenneth M. Farber added, “Lupus nephritis is one of the most common and dangerous complications of lupus. Enabling the generation of therapies for this condition is critical to the Lupus Research Alliance. Using urinary biomarkers to guide therapeutic development aligns with our strategy of supporting work that will help accelerate delivery of new treatments.”

Equillium plans to initiate a Phase 1b proof-of-concept trial of EQ001 in LN in the second half of 2019 to evaluate safety, pharmacokinetics, and clinically-relevant endpoints in patients with refractory LN. As part of its early development program in LN, Equillium plans to also include the co-development and validation of the CD6-ALCAM pathway and other urinary biomarkers as part of the trial and is exploring partnership opportunities in concert with Dr. Mohan and the Lupus Research Alliance to accelerate this research and validation.

Equillium today also provided an update on its existing clinical programs in graft-versus-host-disease (GVHD) and severe asthma.

 

2


LOGO

 

Acute Graft Versus Host Disease

aGVHD occurs when donor immune cells attack host tissues and organs following an allogeneic hematopoietic stem cell transplant (HSCT). Approximately 50 percent of HSCT recipients develop aGVHD, which is the leading cause of non-relapse mortality following HSCT. Equillium is partnering with leading HSCT centers and plans to initiate the Phase 1b/2 EQUATE trial of EQ001 for the frontline treatment of aGVHD by the end of the first quarter of 2019.

Following discussions with the its advisors, Equillium has decided to take a sequential approach to developing EQ001 in GVHD as it contemplates expanding the program. Learnings from the Phase 1b portion of the aGVHD trial will inform our clinical development strategy that includes a broader life-cycle approach, including chronic GVHD, as well as the prevention of GVHD. Equillium believes that this sequential approach enables a more efficient and optimized development program in GVHD.

EQ001 has been granted Fast Track designation for the treatment of aGVHD and Orphan Drug designations for both the prevention and treatment of aGVHD from the U.S. Food and Drug Administration.

Severe Asthma

Asthma is a complex and highly prevalent inflammatory lung disease, characterized by reversible airway obstruction and chronic inflammation that, in severe cases, can significantly impact patient quality of life. Asthma is estimated to affect 26 million people in the United States, but differing cellular and molecular mechanisms vary between patients, resulting in distinct phenotypes and disease severity, for example Th2 or non-Th2 patients, typically referred to as eosinophilic and non-eosinophilic asthma, respectively. Translational data has indicated increased activity of the CD6-ALCAM pathway in severe asthma patients and preclinical data demonstrates that modulating the CD6-ALCAM pathway can inhibit the activity and trafficking of both Th2 and Th17 effector T cells. Therefore, Equillium will initiate a broad development strategy that will evaluate EQ001 in severe asthma, regardless of eosinophilia level, to assess the breadth of its clinical utility.

Equillium plans to initiate a Phase 1b proof-of-concept trial, called the EQUIP trial, in Australia during the second quarter of this year. The trial will focus on patients with uncontrolled asthma despite the use of standard of care treatments. Trial objectives include the assessment of pharmacokinetics, pharmacodynamics, dose finding, safety, and clinically-relevant endpoints. Equillium anticipates reporting topline data from the EQUIP trial in the second half of 2020.

 

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Conference Call and Webcast Information

Equillium management is hosting a conference call to review these and other upcoming milestones in more detail. Details of the call are as follows:

Date: February 26, 2019

Time: 4:30 p.m. ET | 1:30 p.m. PT

Dial-in: (866) 930-5156 (International callers please use (409) 937-8975) and use reservation

code: 7497024. Please dial in 5 to 10 minutes prior to scheduled start time.

Live Webcast: www.equilliumbio.com, accessed through the “Investors” section of the Equillium’s website. The webcast will be archived and available for replay on Equillium’s website for 30 days following the call. Please log on approximately 5 to 10 minutes prior to scheduled start time to download and install any audio software if needed.

About Equillium

Equillium is a biotechnology company leveraging deep understanding of immunobiology to develop products to treat severe autoimmune and inflammatory disorders with high unmet medical need.

Equillium’s initial product candidate, EQ001 (itolizumab), is a clinical-stage, first-in-class monoclonal antibody that selectively targets the novel immune checkpoint receptor CD6. CD6 plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Itolizumab is a clinically-validated therapeutic that has demonstrated a favorable safety and tolerability profile. Equillium acquired rights to EQ001 through an exclusive partnership with Biocon Limited. Equillium believes that EQ001 has the potential to be a best-in-class disease modifying therapeutic and is advancing EQ001 into clinical development in multiple immuno-inflammatory indications with high unmet medical need. For more information, visit www.equilliumbio.com.

Forward Looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, 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 Company’s business strategy, the Company’s plans and expected timing for developing EQ001, including with respect to LN, the impact of certain translational research and the potential benefits of EQ001. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties related to the Company’s plans and product development, including the initiation and completion of clinical trials and whether the results from clinical trials will validate and support the safety and efficacy of EQ001. These and other risks and uncertainties are described more fully under the caption “Risk Factors” and elsewhere in Equillium’s filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release 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.

 

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Investor Contact

+1-858-412-5302

ir@equilliumbio.com

Media Contact

Heidi Chokeir, Ph.D.

Canale Communications

+1-619-203-5391

heidi@canalecomm.com

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