CD6

Itolizumab demonstrated clinical efficacy after 12 weeks of treatment, achieving a clinical remission rate of 23.3% compared to 20.0% for adalimumab and 10.0% for placebo Itolizumab achieved key secondary endpoint of endoscopic remission of 16.7% compared to 16.7% for adalimumab and 6.7% for placebo Itolizumab was generally well tolerated consistent with prior clinical experience LA JOLLA, CA, USA I February 06, 2025 I Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, and Biocon Limited (BSE code: 532523, NSE: BIOCON), an innovation-led global biopharmaceutical company, today announced positive topline results from the Phase 2 study evaluating itolizumab in the treatment of moderate to severe ulcerative colitis (UC). The double-blinded, placebo- and active-controlled Phase 2 clinical study evaluated the safety and efficacy of itolizumab in biologic-naïve patients with moderate to severe active UC. A total of 90 patients were randomized 1:1:1 to receive itolizumab (fixed dose of 140 mg), placebo, or adalimumab (a global standard of care biologic treatment used as an active control) every two weeks for an initial 12-week treatment period. The primary endpoint of the study was clinical remission as defined by Total Mayo Score, and secondary endpoints included the proportion of participants who achieved clinical response and endoscopic remission (evaluated by central endoscopy). The study was co-sponsored by Equillium and Biocon Limited and conducted at multiple clinical trial sites in India. The design and conduct of the trial were a collaborative effort, with input from the gastroenterology community and leading global clinical and scientific experts in the field of inflammatory bowel disease (IBD). “The CD6-ALCAM pathway is elevated in gastrointestinal inflammation and is associated with severity of disease in both ulcerative colitis and Crohn’s patients. As such, we are delighted with the strength of data across the primary and secondary endpoints of this Phase 2 study in moderate to severe ulcerative colitis patients,” said Dr. Stephen Connelly, chief scientific officer at Equillium. “Itolizumab was well tolerated and achieved a clinical remission rate of 23 percent despite an imbalance of more severe patients in the itolizumab arm compared to the other arms of the study. While these positive results add to itolizumab’s critical mass of safety and efficacy data across different patient populations, we are particularly encouraged by this data in the context of our Phase 3 EQUATOR study in acute graft-versus-host disease, where lower gastrointestinal pathogenesis is a key driver of mortality, with topline data expected this quarter.” “Itolizumab demonstrated proof of concept with a meaningful effect size – comparable to biologic standard of care adalimumab – in this Phase 2 study in subjects with moderate to severe ulcerative colitis,” said Dr. Brian Feagan, Professor of Medicine at the Schulich School of Medicine & Dentistry at the University of Western Ontario. “Itolizumab represents a novel selective immune modifying mechanism of action with great potential in a treatment paradigm needing differentiation and improved outcomes for patients.” Summary of Key Study Results Baseline demographics of the study included a median age of 39 years, relatively equal proportions of male and female subjects evenly distributed among study arms, and a mean weight of 58 kilograms. Baseline disease severity of the study was greater in the itolizumab arm, where 23% of patients were classified as severe (Total Mayo Score of 11) versus 0% in the placebo and adalimumab arms, and 66% had left-sided colitis versus 30% and 43% in the placebo and adalimumab arms, respectively. The primary endpoint of the study was clinical remission, defined as Total Mayo Score of ≤ 2 with no individual sub-score greater than 1 at Week 12. Secondary endpoints included the proportion of participants who achieved clinical response (per Total Mayo Score) and endoscopic remission (evaluated by central endoscopy) at Week 12 and Week 24. Additional data is expected to be presented at a future scientific conference during 2025. * One patient from the adalimumab arm had ‘endoscopic remission,’ but was recorded as ‘not in clinical remission’ at week 12 due to missing sub-score data About Itolizumab Itolizumab is a clinical-stage, first-in-class immune-modifying monoclonal antibody that selectively targets the CD6-ALCAM signaling pathway to downregulate pathogenic T effector cells while preserving T regulatory cells critical for maintaining a balanced immune response. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. The blockade of CD6 with itolizumab has demonstrated a reduction in T effector cell proliferation and downregulation of several important pathways that contribute to T effector cell development. The downregulation of these pathways is accompanied by decreased secretion of the pro-inflammatory T effector cytokines IFN-γ, TNF-α, IL-6 and IL-17. Additionally, inhibiting the binding of ALCAM to CD6 modulates lymphocyte trafficking and results in reduced T effector cell infiltration into inflamed tissues. About Biocon Limited Biocon Limited, publicly listed in 2004, (BSE code: 532523, NSE Id: BIOCON, ISIN Id: INE376G01013) is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It has developed and commercialized novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets as well as Generic Formulations in the US, Europe & key emerging markets. It also has a pipeline of promising novel assets in immunotherapy under development. Website: www.biocon.com ; Follow-us on Twitter: @bioconlimited for company updates. About Equillium Equillium is a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need. The company’s pipeline consists of the following novel first-in-class immunomodulatory assets and product platform targeting immuno-inflammatory pathways. Itolizumab: a monoclonal antibody that targets the CD6-ALCAM signaling pathway which plays a central role in the modulation of effector T cells that drive a number of immuno-inflammatory diseases. It is currently under evaluation in a Phase 3 clinical study of patients with acute graft-versus-host disease (aGVHD) and has exhibited positive data from both a Phase 2 clinical study of patients with moderate to severe ulcerative colitis and a Phase 1b clinical study of patients with lupus/lupus nephritis. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited, who also provides commercial manufacturing for the product. EQ101: a selective tri-specific cytokine inhibitor targeting IL-2, IL-9, and IL-15, has exhibited positive results in both a Phase 2 proof-of-concept clinical study of patients with moderate to severe alopecia areata and a Phase 1/2 proof-of-concept clinical study of patients with cutaneous T cell lymphoma (CTCL). EQ302: an orally delivered, selective bi-specific cytokine inhibitor targeting IL-15 and IL-21 at pre-clinical stage. For more information, visit www.equilliumbio.com . SOURCE: Equillium

LA JOLLA, Calif.--( BUSINESS WIRE )--Equillium Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced financial results for the second quarter 2024 and provided an update on corporate and clinical highlights. “We recently announced a positive interim review of the Phase 3 EQUATOR study by the Independent Data Monitoring Committee, which raised no safety or futility concerns and recommended that the study proceed as planned,” said Bruce Steel, chief executive officer at Equillium. “We have delivered the blinded interim data, along with the data monitoring committee’s recommendation, to our partner Ono Pharmaceutical, who now has until the end of October 2024 to make its decision to acquire our rights to itolizumab. Should Ono exercise its option, Equillium would receive a one-time payment of JPY 5.0 billion, or approximately $35.0 million based on the currency exchange rate on August 5, 2024, significantly extending the company’s cash runway. Equillium would also be eligible to receive up to USD $101.4 million upon the achievement of certain clinical, regulatory, and commercialization milestones, as well as continued reimbursement of itolizumab-related expenses.” Mr. Steel continued, “We continue to advance our multi-cytokine assets and platform. Following positive topline data from the Phase 2 study of EQ101 in subjects with alopecia areata, we are proceeding with preparations to conduct a Phase 2b placebo-controlled study, which would include transitioning from intravenous to subcutaneous delivery and dose optimization. In parallel, we continue to advance EQ302, a novel orally available bi-specific inhibitor of IL-15/IL-21, with a goal to initiate Phase 1 clinical development in the second half of next year.” Highlights Since the Beginning of the Second Quarter of 2024: Triggered Ono Pharmaceutical Co., Ltd. (Ono) option exercise period to acquire Equillium’s rights to itolizumab by delivering positive topline data from Phase 1b EQUALISE study in lupus nephritis patients, and positive recommendation from Independent Data Monitoring Committee’s review of interim data from Phase 3 EQUATOR study in acute graft-versus-host disease subjects Announced positive topline data from Phase 2 study of EQ101 in alopecia areata subjects, including 29% of completed subjects with moderate to severe disease achieving SALT (Severity Alopecia Tool) ≤ 20 Announced poster presentation at the annual meeting of the American Association of Immunologists, highlighting that itolizumab blocks the binding of CD6 to ALCAM and induces the stripping of the receptor on the T cells’ membrane in the presence of antigen presenting cells, generating CD6 low T cells Anticipated Upcoming Milestones: Ono option exercise decision – end of October 2024 EQ101: Transition to subcutaneous delivery and initiate Phase 2 dose optimization study in alopecia areata – 2025 EQ302: Initiate Phase 1 study – 2H 2025 Second Quarter 2024 Financial Results Revenue for the second quarter of 2024 was $13.9 million, compared to $9.1 million during the same period in 2023. Revenue in the second quarters of 2024 and 2023 consisted entirely of itolizumab development funding and amortization of the upfront payment resulting from the Asset Purchase Agreement with Ono. In the second quarter of 2024, development funding represented $9.2 million, and amortization of the upfront payment represented $4.7 million, whereas those two components represented $6.8 million and $2.3 million, respectively, in the second quarter of 2023. Research and development (R&D) expenses for the second quarter of 2024 were $10.8 million, compared to $9.6 million for the same period in 2023. The increase was primarily due to greater expenses associated with chemistry, manufacturing and controls (CMC) activities related to itolizumab to support a potential biologics license application (BLA) filing related to the EQUATOR study, and greater clinical study expenses related to EQUATOR, which were partially offset by lower clinical study expenses related to EQUALISE and EQ102 clinical studies. General and administrative (G&A) expenses were $3.1 million for each of the three-month periods ended June 30, 2024 and 2023. Net income for the second quarter of 2024 was $0.5 million, or $0.01 per basic and diluted share, compared with a net loss of $3.3 million, or $(0.10) per basic and diluted share, for the same period in 2023. The increase in net income was primarily driven by greater revenue related to our Asset Purchase Agreement with Ono. Cash, cash equivalents and short-term investments totaled $33.3 million as of June 30, 2024, compared to $32.3 million as of March 31, 2024. The increase was primarily driven by the receipt of Equillium’s 2023 Australian tax credit claim in the second quarter of 2024, as well as itolizumab development funding payments from Ono. Cash provided by operating activities in the second quarter of 2024 was $0.7 million. Equillium believes that its cash, cash equivalents and short-term investments are sufficient to fund operations for at least the next 12 months, assuming no further repurchases under our stock repurchase program, and by making adjustments to discretionary spending, if Ono does not exercise its option. About Multi-Cytokine Platform and Multi-Cytokine Inhibitors EQ101 & EQ302 Our proprietary multi-cytokine platform generates rationally designed composite peptides that selectively block key cytokines at the shared receptor level targeting pathogenic cytokine redundancies and synergies while preserving non-pathogenic signaling. This approach is expected to avoid the broad immuno-suppression and off-target safety liabilities that may be associated with other therapeutic classes, such as Janus kinase inhibitors. Many immune-mediated diseases are driven by the same combination of dysregulated cytokines, and we believe identifying the key cytokines for these diseases will allow us to target and develop customized treatment strategies for multiple autoimmune and inflammatory diseases. Current platform assets include EQ101, a clinical stage, first-in-class, selective, tri-specific inhibitor of IL-2, IL-9, and IL-15 for intravenous and subcutaneous delivery and EQ302, a preclinical stage, first-in-class, selective, bi-specific inhibitor of IL-15 and IL-21 for oral delivery. About Itolizumab Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM signaling pathway to downregulate pathogenic T effector cells while preserving T regulatory cells critical for maintaining a balanced immune response. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. About Equillium Equillium is a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need. The company’s pipeline consists of the following novel first-in-class immunomodulatory assets and product platform targeting immuno-inflammatory pathways. EQ101: a selective tri-specific cytokine inhibitor targeting IL-2, IL-9, and IL-15; recently announced positive results from a Phase 2 proof-of-concept clinical study of patients with alopecia areata. EQ302: an orally delivered, selective bi-specific cytokine inhibitor targeting IL-15 and IL-21; currently in pre-clinical development. The multi-cytokine platform: generates rationally designed composite peptides that selectively block key cytokines at the shared receptor level targeting pathogenic cytokine redundancies and synergies while preserving non-pathogenic signaling. Itolizumab: a monoclonal antibody that targets the CD6-ALCAM signaling pathway which plays a central role in the modulation of effector T cells; currently under evaluation in a Phase 3 clinical study of patients with acute graft-versus-host disease (aGVHD) and announced positive data from a Phase 1b clinical study of patients with lupus/lupus nephritis in April 2024. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited and has entered a strategic partnership with Ono Pharmaceutical Co., Ltd., for the development and commercialization of itolizumab under an option and asset purchase agreement. 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. These statements include, but are not limited to, statements regarding Equillium’s plans for developing EQ101, EQ302 and itolizumab and the expected timeline for initiating additional clinical studies, anticipated upcoming milestones, expected timing for Ono to make its decision regarding exercising its option and the potential consideration that may be payable to Equillium, potential additional consideration upon the achievement of certain development, regulatory, and commercialization milestones under the Ono asset purchase agreement, the potential benefits and extended cash runway if Ono exercises their option, the fluctuation of the foreign exchange rate, Equillium’s cash runway and related assumptions, and the potential benefits of Equillium’s product candidates. Because such statements are subject to risks and uncertainties, many of which are outside of Equillium’s control, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: Equillium’s ability to execute its plans and strategies; risks related to performing clinical and pre-clinical studies; whether the results from clinical and pre-clinical studies will validate and support the safety and efficacy of Equillium’s product candidates; Equillium’s ability to transition from intravenous to subcutaneous delivery and dose optimization for the Phase 2b placebo-controlled study of EQ101; changes in the competitive landscape; risks related to Ono’s financial condition and decision to exercise its option, if ever, to purchase itolizumab, and the risk that Equillium may never receive any of the contingent consideration under the Ono asset purchase agreement; 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, which may be accessed for free by visiting the Securities and Exchange Commission’s website 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 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, except as required by law. Equillium, Inc. Condensed Consolidated Balance Sheets (In thousands) (unaudited) June 30, December 31, 2024 2023 Assets Cash, cash equivalents and short-term investments $ 33,299 $ 40,866 Accounts receivable 5,893 3,735 Prepaid expenses and other assets 3,077 5,133 Operating lease right-of-use assets 592 796 Total assets $ 42,861 $ 50,530 Current liabilities Accounts payable and other current liabilities $ 11,739 $ 11,844 Current portion of deferred revenue 8,430 15,729 Total current liabilities 20,169 27,573 Long-term operating lease liabilities 259 384 Total liabilities 20,428 27,957 Total stockholders' equity 22,433 22,573 Total liabilities and stockholders' equity $ 42,861 $ 50,530 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, 2024 2023 2024 2023 Revenue $ 13,853 $ 9,124 $ 24,542 $ 18,003 Operating expenses: Research and development 10,808 9,610 20,551 18,882 General and administrative 3,145 3,105 6,883 6,820 Total operating expenses 13,953 12,715 27,434 25,702 Loss from operations (100 ) (3,591 ) (2,892 ) (7,699 ) Total other income, net 568 256 626 484 Income (loss) before income taxes 468 (3,335 ) (2,266 ) (7,215 ) Income tax expense - 8 - 68 Net income (loss) $ 468 $ (3,343 ) $ (2,266 ) $ (7,283 ) Net income (loss) per share: Basic $ 0.01 $ (0.10 ) $ (0.06 ) $ (0.21 ) Diluted $ 0.01 $ (0.10 ) $ (0.06 ) $ (0.21 ) Weighted-average number of common shares outstanding: Basic 35,292,035 34,449,769 35,273,394 34,432,057 Diluted 36,589,774 34,449,769 35,273,394 34,432,057

CD6 contributes to cell adhesion/migration both through direct ligand interactions with activated leukocyte cell adhesion molecule (ALCAM) and through the stabilization of cell membrane VLA4 Blockade of CD6 through itolizumab prevents the trans-endothelial migration of effector T cells Data supports the differentiated mechanism of action of itolizumab LA JOLLA, Calif.--(BUSINESS WIRE)-- Equillium, Inc., Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that a poster was presented at IMMUNOLOGY2024, the annual meeting of The American Association of Immunologists. The meetings are taking place at McCormick Place Convention Center in Chicago, Illinois, May 3 – 7. “Our data demonstrates that CD6 contributes to cell adhesion/migration both through direct ligand interactions with ALCAM and through the stabilization of cell membrane VLA4, and that these functions can be abrogated by itolizumab,” said Dr. Stephen Connelly, chief scientific officer at Equillium. “We previously showed that blockade of CD6 prevents the trans-endothelial migration of effector T cells and this new data further elucidates the molecular mechanism. Moreover, our data continues to demonstrate that increased levels of CD6 facilitate the migration of pathogenic effector T cells into inflamed tissues and that itolizumab can modulate not only their activity, but trafficking too.” Title: Surface CD6 regulates T cell adhesion and migration through direct ligand interaction and stabilization of VLA4 Lead Author: Valeria Marrocco, Senior Scientist, Equillium, Inc. Presentation Type: Poster Session Poster Number: P713 Abstract ID: 4364 Session Title: Migration and Adhesion in Inflammation, Cancer, and Metabolic Disorders Key Highlights, Summaries & Conclusions from Presentation: Itolizumab not only blocks the binding of CD6 to ALCAM, but it also induces the stripping of the receptor on the T cells’ membrane in the presence of antigen presenting cells, generating CD6 low T cells. Reduction of CD6 on T cells or blocking of ALCAM on the human umbilical vein endothelial cells (HUVEC), prevents the adhesion of Effector T cells to the endothelial monolayer. Itolizumab treatment significantly reduced the trans-endothelial migration of pathogenic T cells, with high correlation of effector T cells’ migration index with the CD6 levels on the cell surface. Itolizumab treatments reduced the gene expression important for cell motility and downregulated VLA4 integrin levels on the cell surface and the total protein levels. Data identifies a new role of the CD6-ALCAM pathway in adhesion and trans-endothelial migration of effector T cells and demonstrated that CD6 expression at the membrane is required for the expression and stabilization of the integrin VLA4. This suggests a direct role of the CD6-ALCAM pathway and indirect T cell mobility regulation through downregulation of VLA4. The poster presentation is available on the Presentations page of Equillium’s website under the “Itolizumab MOA” tab. About Itolizumab Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody that selectively targets the CD6-ALCAM signaling pathway to selectively downregulate pathogenic T effector cells while preserving T regulatory cells critical for maintaining a balanced immune response. This pathway plays a central role in modulating the activity and trafficking of T cells that drive a number of immuno-inflammatory diseases. About Equillium Equillium is a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders with high unmet medical need. The company’s pipeline consists of the following novel first-in-class immunomodulatory assets and product platform targeting immuno-inflammatory pathways. EQ101: a selective tri-specific cytokine inhibitor targeting IL-2, IL-9, and IL-15; currently under evaluation in a Phase 2 proof-of-concept clinical study of patients with alopecia areata being conducted in Australia and New Zealand by Equillium’s Australian subsidiary as the trial sponsor. EQ302: an orally delivered, selective bi-specific cytokine inhibitor targeting IL-15 and IL-21; currently in pre-clinical development. The multi-cytokine platform: generates rationally designed composite peptides that selectively block key cytokines at the shared receptor level targeting pathogenic cytokine redundancies and synergies while preserving non-pathogenic signaling. Itolizumab: a monoclonal antibody that targets the CD6-ALCAM signaling pathway which plays a central role in the modulation of effector T cells; currently under evaluation in a Phase 3 clinical study of patients with acute graft-versus-host disease (aGVHD) and recently completed a Phase 1b clinical study of patients with lupus/lupus nephritis. Equillium acquired rights to itolizumab through an exclusive partnership with Biocon Limited and has entered a strategic partnership with Ono Pharmaceutical Co., Ltd., for the development and commercialization of itolizumab under an option and asset purchase agreement. For more information, visit . 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, many of which are outside of Equillium’s control, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks that contribute to the uncertain nature of the forward-looking statements include: Equillium’s ability to execute its plans and strategies; risks related to performing clinical studies; whether the results from clinical studies will validate and support the safety and efficacy of Equillium’s product candidates. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in Equillium's filings and reports, which may be accessed for free by visiting the Securities and Exchange Commission’s website at 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 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, except as required by law.