EQ Equillium Inc.

6.38
+0.45  (+8%)
Previous Close 5.93
Open 5.82
52 Week Low 3.47
52 Week High 11.33
Market Cap $187,462,302
Shares 29,382,806
Float 16,153,503
Enterprise Value $86,664,039
Volume 103,910
Av. Daily Volume 124,034
Stock charts supplied by TradingView

Upcoming Catalysts

Drug Stage Catalyst Date
Itolizumab (EQ001) - (EQUALISE)
Systemic lupus erythematosus (SLE) and lupus nephritis (LN)
Phase 1b
Phase 1b
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.
Itolizumab (EQ001) - (EQUIP)
Asthma
Phase 1b
Phase 1b
Lorem ipsum dolor sit amet, consectetur adipiscing elit. Quisque sapien.

Drug Pipeline

Drug Stage Notes
Itolizumab (EQ001)
Acute graft-versus-host disease
Phase 3
Phase 3
Phase 3 trial to be initiated 4Q 2021.
Itolizumab (EQ001)
COVID-19
Phase 3
Phase 3
Phase 3 trial will not be initiated - November 25, 2020.

Latest News

  1. Equillium, Inc. (NASDAQ:EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders with high unmet medical need, today announced that it will present at the H.C. Wainwright 23rd Annual Global Investment Conference, taking place September 13 – 15, 2021. The virtual on-demand presentation will be available as of Monday, September 13, 2021, at 7:00 am ET.

    Bruce Steel, Equillium's chief executive officer, and Dolca Thomas M.D., Equillium's executive vice president of research and development and chief medical officer, will provide a high-level overview of itolizumab's mechanism of action and review each of the ongoing clinical programs. The presentation will focus on topline data from…

    Equillium, Inc. (NASDAQ:EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders with high unmet medical need, today announced that it will present at the H.C. Wainwright 23rd Annual Global Investment Conference, taking place September 13 – 15, 2021. The virtual on-demand presentation will be available as of Monday, September 13, 2021, at 7:00 am ET.

    Bruce Steel, Equillium's chief executive officer, and Dolca Thomas M.D., Equillium's executive vice president of research and development and chief medical officer, will provide a high-level overview of itolizumab's mechanism of action and review each of the ongoing clinical programs. The presentation will focus on topline data from the company's Phase 1b EQUATE study in acute graft-versus-host disease (aGVHD) and recent regulatory feedback leading directly to a pivotal Phase 3 study in aGVHD, to be initiated before the end of 2021. Mr. Steel and Dr. Thomas will be available for one-on-one meetings during the conference.

    The webcast will be available for 90 days under the "Investors" section of the Company's website at https://ir.equilliumbio.com/events-and-presentations.

    About Equillium

    Equillium is a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop novel products to treat severe autoimmune and inflammatory disorders with high unmet medical need. Equillium is developing itolizumab for multiple severe immuno-inflammatory diseases, including acute graft-versus-host-disease (aGVHD), lupus/lupus nephritis and uncontrolled asthma.

    For more information, visit www.equilliumbio.com.

    View Full Article Hide Full Article
  2. Analysis of our Type A systemic lupus erythematosus patients without lupus nephritis that had elevated baseline urine protein/creatinine and albumin/creatinine ratios demonstrated a mean decrease of 42% and 53% respectively by Day 57 following two doses of Itolizumab

    The Type B lupus nephritis cohort has been expanded to include newly diagnosed patients, in addition to refractory patients, and will evaluate a single subcutaneous dose level based on Type A PK/PD results

    Equillium, Inc. (NASDAQ:EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders with high unmet medical need, today announced additional data from the EQUALISE Type A portion of the study in systemic lupus erythematosus…

    Analysis of our Type A systemic lupus erythematosus patients without lupus nephritis that had elevated baseline urine protein/creatinine and albumin/creatinine ratios demonstrated a mean decrease of 42% and 53% respectively by Day 57 following two doses of Itolizumab

    The Type B lupus nephritis cohort has been expanded to include newly diagnosed patients, in addition to refractory patients, and will evaluate a single subcutaneous dose level based on Type A PK/PD results

    Equillium, Inc. (NASDAQ:EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders with high unmet medical need, today announced additional data from the EQUALISE Type A portion of the study in systemic lupus erythematosus (SLE) patients. The exploratory data set shows that patients without a diagnosis of lupus nephritis (LN) but with elevated urine protein/creatine ratio (UPCR) >200 mg/g (N=6, baseline geometric mean 378 mg/g)1 experienced a mean decrease from baseline in UPCR of 33% and 42% at Days 29 and 57 respectively, following subcutaneous doses of itolizumab on Days 1 and 15. Notably, one subject who had baseline UPCR of 1,505 mg/g declined to 974 mg/g at Day 29 and 857 mg/g by Day 57. Additionally, patients with elevated albumin/creatinine ratio (ACR) >30 mg/g (N=4, baseline geometric mean 97 mg/g)1 experienced a mean decrease from baseline in ACR of 22% and 53% at Days 29 and 57 respectively.

    "We are intrigued by this observation from our Type A portion of the study in SLE patients who did not have a diagnosis of lupus nephritis and entered the study with elevated proteinuria, and experienced reductions in UPCR and ACR following two doses of itolizumab," said Dolca Thomas, executive vice president of research and development and chief medical officer of Equillium. "There is ongoing research in the field of rheumatology and nephrology that suggests patients who have elevated proteinuria with UPCR greater than 200 mg/g or ACR greater that 30 mg/g, which is below the typical diagnostic threshold for LN and other kidney diseases, may have subclinical disease - sometimes referred to as silent LN - where early intervention with a safe and active therapy may prevent more severe outcomes. We are continuing to analyze this exploratory data and look forward to initial results from active LN patients in the Type B portion of the EQUALISE study that is now enrolling."

    Equillium is implementing an amendment to the Type B portion of the EQUALISE study in LN patients to include newly diagnosed patients in addition to refractory patients. The study will evaluate up to 20 patients dosed at 1.6 mg/kg subcutaneously bi-weekly for up to 24 weeks. The selection of the 1.6 mg/kg dose was based on the totality of the safety, tolerability, and PK/PD data in the Type A portion of the study that demonstrated a plateau in the reduction of CD6 cell surface expression above the 0.8 mg/kg dose; as previously reported itolizumab was safe and well tolerated through the 2.4 mg/kg dose level. Equillium expects to announce interim data from the Type B portion of the study by the end of the year. Equillium has received fast track designation from the FDA for itolizumab for the treatment of patients with lupus nephritis.

    1 Missing data: UPCR on one patient at Day 57, ACR on two patients at Day 29

    About Systemic Lupus Erythematosus (SLE) / Lupus Nephritis (LN)

    Systemic lupus erythematosus is an autoimmune disease in which the immune system attacks its own tissues, causing widespread inflammation and tissue damage in the affected organs. It can affect the joints, skin, brain, lungs, kidneys, and blood vessels. Lupus nephritis is a serious complication of SLE, occurring in approximately 30% – 60% of individuals with SLE. In LN, the body's own immune system attacks the kidneys, causing inflammation and significantly reducing kidney function over time.

    About the EQUALISE Study

    The EQUALISE study is a Phase 1b open-label proof-of-concept multiple ascending-dose clinical study of itolizumab in patients with systemic lupus erythematosus and lupus nephritis. The study is evaluating the safety and tolerability of subcutaneous delivery of itolizumab in patients with systemic lupus erythematosus and lupus nephritis. The treatment period for patients with systemic lupus erythematosus is two weeks in duration, while treatment for patients with active proliferative lupus nephritis is 24 weeks in duration.

    About Itolizumab

    Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.

    About Equillium

    Equillium is a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop novel products to treat severe autoimmune and inflammatory disorders with high unmet medical need. Equillium is developing itolizumab for multiple severe immuno-inflammatory diseases, including acute graft-versus-host-disease (aGVHD), lupus/lupus nephritis and uncontrolled asthma.

    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. 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, 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 potential benefit of treating patients with aGVHD, uncontrolled asthma, or 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 EQUATE, EQUIP, and EQUALISE studies, the potential for any of Equillium's ongoing or planned clinical studies to show safety or efficacy, statements regarding the impact of new leadership team members, Equillium's anticipated timing of regulatory review and feedback, Equillium's cash runway, and Equillium's plans and expected timing for developing itolizumab and potential benefits of itolizumab. Risks that contribute to the uncertain nature of the forward-looking statements include: 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; 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; 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 itolizumab; changes in the competitive landscape; uncertainties related to Equillium's capital requirements; and having to use cash in ways or on timing other than expected and the impact of market volatility on cash reserves. 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 SEC. 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.

    View Full Article Hide Full Article
  3. Announced positive topline results from the EQUATE study of itolizumab in first-line treatment of acute graft-versus-host disease

    Announced plans to initiate a Phase 3 pivotal study of itolizumab in first-line treatment of acute graft-versus-host disease

    Equillium, Inc. (NASDAQ:EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders with high unmet medical need, today announced financial results for the second quarter 2021, and provided an update on its clinical programs.

    "The second quarter of the year was highlighted by positive data from our Phase 1b EQUATE study in acute graft-versus-host disease," said Bruce Steel, chief executive officer at Equillium. "These data were…

    Announced positive topline results from the EQUATE study of itolizumab in first-line treatment of acute graft-versus-host disease

    Announced plans to initiate a Phase 3 pivotal study of itolizumab in first-line treatment of acute graft-versus-host disease

    Equillium, Inc. (NASDAQ:EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders with high unmet medical need, today announced financial results for the second quarter 2021, and provided an update on its clinical programs.

    "The second quarter of the year was highlighted by positive data from our Phase 1b EQUATE study in acute graft-versus-host disease," said Bruce Steel, chief executive officer at Equillium. "These data were critical for achieving a positive outcome from our End-of-Phase 1 meeting with the FDA and accelerating our plans to immediately advance to a single, pivotal Phase 3 clinical study. This strategy, if successful, may position itolizumab to become the first approved therapy to treat patients with acute graft-versus-host disease in the first-line setting."

    Corporate & Clinical Highlights Since Beginning of Q2 2021:

    • Announced positive topline results from the EQUATE study in first-line treatment of acute graft-versus-host disease presented at the 2021 Virtual Congress of the European Hematology Association, and plans to initiate a Phase 3 pivotal study following an End-of-Phase 1 meeting with the FDA
      • Itolizumab continues to demonstrate favorable safety and efficacy profile
      • Rapid and durable complete responses resulted in clinically meaningful reduction in corticosteroid use
      • Data support clinical advancement of itolizumab in first-line treatment of aGVHD
    • Presented multiple posters at the 104th annual meeting of the American Association of Immunologists; research highlighted:
      • Itolizumab's novel mechanism of action and its effect on modulating T cell responses through inhibition of the CD6-ALCAM pathway
      • Development of a pharmacodynamic biomarker assay to monitor target engagement and fate of CD6 on T cells in patients treated with itolizumab

    Upcoming Catalysts:

    • EQUALISE Phase 1b study: interim data from Type B patients (lupus nephritis) expected 2H 2021
    • EQUIP Phase 1b study: topline data in uncontrolled asthma expected 2H 2021
    • Initiate pivotal study in first-line aGVHD expected Q4 2021

    Second Quarter 2021 Financial Results

    Research and development (R&D) expenses for the second quarter of 2021 were $6.0 million, compared with $3.9 million for the same period in 2020. The increase was driven by greater employee compensation and benefit expenses primarily related to increased headcount, an increase in clinical development expenses primarily related to the EQUATE and EQUALISE studies, as well as greater consulting, overhead, and non-clinical research expenses.

    General and administrative (G&A) expenses for the second quarter of 2021 were $2.9 million, compared with $2.7 million for the same period in 2020. The increase was driven by greater employee compensation and benefits primarily related to increased headcount, partially offset by a decrease in non-cash stock-based compensation mainly due to retention option grants issued to certain officers and directors in the second quarter of 2020.

    Net loss for the second quarter of 2021 was $9.2 million, or $(0.31) per basic and diluted share, compared with a net loss of $6.5 million, or $(0.37) per basic and diluted share for the same period in 2020. The increase in net loss was largely attributable to greater operating expenses.

    Cash used in operations for the second quarter of 2021 was $7.0 million compared to $7.9 million in the first quarter of 2021.

    Cash, cash equivalents and short-term investments totaled $97.6 million as of June 30, 2021, compared to $104.1 million as of March 31, 2021. Equillium believes that its cash and investments will be sufficient to fund its currently planned operations into 2023.

    About Itolizumab

    Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.

    About Equillium

    Equillium is a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop novel products to treat severe autoimmune and inflammatory disorders with high unmet medical need. Equillium is developing itolizumab for multiple severe immuno-inflammatory diseases, including acute graft-versus-host-disease (aGVHD), lupus/lupus nephritis and uncontrolled asthma.

    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 potential benefit of treating patients with aGVHD, uncontrolled asthma, or 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 EQUATE, EQUIP, and EQUALISE studies, the potential for any of Equillium's ongoing or planned clinical studies to show safety or efficacy, statements regarding the impact of new leadership team members, Equillium's anticipated timing of regulatory review and feedback, Equillium's cash runway, and Equillium's plans and expected timing for developing itolizumab and potential benefits of itolizumab. Risks that contribute to the uncertain nature of the forward-looking statements include: 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; 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; 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 itolizumab; changes in the competitive landscape; uncertainties related to Equillium's capital requirements; and having to use cash in ways or on timing other than expected and the impact of market volatility on cash reserves. 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 SEC. 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.

    Equillium, Inc.

    Condensed Consolidated Balance Sheets

    (In thousands)

    (unaudited)

     

     

     

    June 30,

     

    December 31,

     

     

     

    2021

     

     

    2020

     

     

     

     

     

    Cash, cash equivalents and short-term investments

     

    $

    97,643

     

    $

    82,163

    Prepaid expenses and other assets

     

     

    2,194

     

     

    3,265

    Total assets

     

    $

    99,837

     

    $

    85,428

    Current liabilities

     

     

    4,980

     

     

    7,245

    Long-term notes payable

     

     

    10,067

     

     

    8,275

    Other non-current liabilities

     

     

    17

     

     

    54

    Total stockholders' equity

     

     

    84,773

     

     

    69,854

    Total liabilities and stockholders' equity

     

    $

    99,837

     

    $

    85,428

    Equillium, Inc.

    Condensed Consolidated Statements of Operations

    (In thousands, except share and per share data)

    (unaudited)

     

     

    Three Months Ended

    June 30,

     

    Six Months Ended

    June 30,

     

     

    2021

     

     

    2020

     

     

     

    2021

     

     

     

    2020

     

     

     

     

     

    Operating expenses:

    Research and development

    $

    5,985

     

    $

    3,893

     

    $

    11,865

     

    $

    8,599

     

    General and administrative

     

    2,858

     

     

    2,717

     

     

    5,673

     

     

    5,463

     

    Total operating expenses

     

    8,843

     

     

    6,610

     

     

    17,538

     

     

    14,062

     

    Loss from operations

     

    (8,843

    )

     

    (6,610

    )

     

    (17,538

    )

     

    (14,062

    )

    Other (expense) income, net

     

    (315

    )

     

    149

     

     

    (611

    )

     

    (236

    )

    Net loss

    $

    (9,158

    )

    $

    (6,461

    )

    $

    (18,149

    )

    $

    (14,298

    )

    Net loss per common share, basic and diluted

    $

    (0.31

    )

    $

    (0.37

    )

    $

    (0.64

    )

    $

    (0.81

    )

    Weighted-average number of common shares outstanding, basic and diluted

     

    29,076,562

     

     

    17,692,731

     

     

    28,205,805

     

     

    17,627,641

     

     

    View Full Article Hide Full Article
  4. Equillium, Inc. (NASDAQ:EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, announced today that it will present at the BTIG Virtual Biotechnology Conference, taking place August 9 & 10, 2021.

    Bruce Steel, Equillium's chief executive officer, and Dolca Thomas, M.D., Equillium's executive vice president of research and development and chief medical officer, will provide a high-level overview of the Company's clinical focus before engaging in a Fireside Chat with BTIG equity research analyst Justin Zelin.

    Date:

         

    Tuesday, August 10, 2021

    Time:

         

    12:00 PM Eastern Time | 9:00 AM Pacific Time

    Location:

         

    Virtual Webcast

    BTIG-hosted events are intended…

    Equillium, Inc. (NASDAQ:EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, announced today that it will present at the BTIG Virtual Biotechnology Conference, taking place August 9 & 10, 2021.

    Bruce Steel, Equillium's chief executive officer, and Dolca Thomas, M.D., Equillium's executive vice president of research and development and chief medical officer, will provide a high-level overview of the Company's clinical focus before engaging in a Fireside Chat with BTIG equity research analyst Justin Zelin.

    Date:

         

    Tuesday, August 10, 2021

    Time:

         

    12:00 PM Eastern Time | 9:00 AM Pacific Time

    Location:

         

    Virtual Webcast

    BTIG-hosted events are intended for prospective and existing BTIG clients only. To listen to the live event, please contact your BTIG representative with interest.

    About Equillium

    Equillium is a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop novel products to treat severe autoimmune and inflammatory disorders with high unmet medical need. Equillium is developing itolizumab for multiple severe immuno-inflammatory diseases, including acute graft-versus-host-disease (aGVHD), lupus/lupus nephritis and uncontrolled asthma.

    For more information, visit www.equilliumbio.com.

    View Full Article Hide Full Article
  5. Single pivotal Phase 3 study in acute graft-versus-host disease to
    support filing of biologics license application

    On track to initiate study in Q4 2021

    LA JOLLA, Calif., July 12, 2021 (GLOBE NEWSWIRE) -- Equillium, Inc. (NASDAQ:EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced the completion of an End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) for itolizumab in first-line treatment of patients with acute graft-versus-host disease (aGVHD). The meeting confirmed a path to advance itolizumab into a single Phase 3 pivotal study to support the Biologics License Application (BLA) filing for itolizumab in first-line treatment of aGVHD…

    Single pivotal Phase 3 study in acute graft-versus-host disease to

    support filing of biologics license application

    On track to initiate study in Q4 2021

    LA JOLLA, Calif., July 12, 2021 (GLOBE NEWSWIRE) -- Equillium, Inc. (NASDAQ:EQ), a clinical-stage biotechnology company developing itolizumab to treat severe autoimmune and inflammatory disorders, today announced the completion of an End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) for itolizumab in first-line treatment of patients with acute graft-versus-host disease (aGVHD). The meeting confirmed a path to advance itolizumab into a single Phase 3 pivotal study to support the Biologics License Application (BLA) filing for itolizumab in first-line treatment of aGVHD patients. The company plans to initiate the Phase 3 study in Q4 2021.

    "Following the positive outcome of our meeting with the FDA, we will immediately advance to a pivotal clinical study, moving one step closer to developing the first approved therapy to treat aGVHD patients in the first-line setting," said Dolca Thomas, executive vice president of research and development and chief medical officer of Equillium. "This extremely ill patient population is significantly underserved by today's standard of care – high-dose corticosteroids. Our EQUATE Phase 1b study demonstrated rapid and durable complete clinical responses and a swift reduction in systemic corticosteroid use that are critical for positive longer-term patient outcomes. Itolizumab has received FDA fast track and orphan drug designations for the treatment of aGVHD, and with this feedback from the FDA we are immediately transitioning to late-stage development and look forward to collecting the data needed to support a BLA filing."

    The meeting provided guidance from the FDA on the pivotal study design, as well as advice on chemistry, manufacturing and controls (CMC), nonclinical and regulatory-related topics to support Equillium's proposed single pivotal clinical study and BLA submission of itolizumab for the first-line treatment of aGVHD in combination with corticosteroids. The randomized double-blinded pivotal study will evaluate one dosing regimen of itolizumab versus standard of care (high-dose corticosteroids) and will include complete response at Day 29 as the primary endpoint, with an interim evaluation for futility and efficacy at 50% patient enrollment. Equillium is finalizing details of the Phase 3 protocol based on feedback and guidance from the FDA.

    About Graft-Versus-Host Disease (GVHD)

    GVHD is a multisystem disorder that is a common complication of allogeneic hematopoietic stem cell transplants (allo-HSCT) caused by the transplanted immune system recognizing and attacking the recipient's body. Symptoms of GVHD include rash, itching, skin discoloration, nausea, vomiting, diarrhea, and jaundice, as well as eye dryness and irritation.

    GVHD is the leading cause of non-relapse mortality in cancer patients receiving allo-HSCT, and its risk limits the number and type of patients receiving HSCT. GVHD results in high morbidity and mortality, with five-year survival of approximately 53% in patients who respond to steroid treatment and mortality as high as 95% in patients who do not respond to steroids. There are no approved treatments for first-line aGVHD. Published literature (MacMillan et al., 2015) describes background response rates to high-dose steroid administration in severe high-risk patients as 43% overall response and 27% complete response.

    About Itolizumab

    Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM pathway. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited.

    About Equillium

    Equillium is a clinical-stage biotechnology company leveraging deep understanding of immunobiology to develop novel products to treat severe autoimmune and inflammatory disorders with high unmet medical need. Equillium is developing itolizumab for multiple severe immuno-inflammatory diseases, including a planned pivotal study in acute graft-versus-host-disease (aGVHD), a Phase 1b study in lupus/lupus nephritis and a Phase 1b study in uncontrolled asthma.

    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. Words such as "expect," "estimate," "project," "budget," "forecast," "anticipate," "intend," "plan," "may," "will," "could," "should," "believes," "predicts," "potential," "continue" and similar expressions are intended to identify such forward-looking statements. 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 capitalization, resources and funding of Equillium, the potential benefit of treating patients with aGVHD with itolizumab, Equillium's plans and expected timing for developing itolizumab including the expected timing of initiating, completing and announcing further results from the acute graft-versus-host disease program, the potential for any of Equillium's ongoing or planned clinical studies to show safety or efficacy, statements regarding the impact of new leadership team members, Equillium's anticipated timing of regulatory review and feedback, and Equillium's plans and expected timing for developing itolizumab and potential benefits of itolizumab. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties related to the abilities of new leadership team members to integrate and perform as expected; Equillium's ability to execute its plans and strategies; risks related to performing clinical studies; 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; 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 itolizumab; changes in the competitive landscape; uncertainties related to Equillium's capital requirements; and having to use cash in ways or on timing other than expected and the impact of market volatility on cash reserves. These and other risks and uncertainties are described more fully under the caption "Risk Factors" in Equillium's Annual Report on Form 10-K for the year ended December 31, 2020, and elsewhere in Equillium's filings and reports with the SEC. 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.

    Investor Contact

    Michael Moore

    Vice President, Investor Relations & Corporate Communications

    619-302-4431

    ir@equilliumbio.com

    Media Contacts

    Aljanae Reynolds

    Wheelhouse Life Science Advisors

    areynolds@wheelhouselsa.com



    Primary Logo

    View Full Article Hide Full Article
View All Equillium Inc. News