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LA JOLLA, Calif.--( BUSINESS WIRE )-- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced an update on multi-cytokine programs EQ101 in development for the treatment of alopecia areata, EQ102 in development for the treatment of celiac disease, and EQ302, a new orally delivered multi-cytokine inhibitor. “We are pleased to have completed enrollment of the EQ101 Phase 2 study in alopecia areata,” said Bruce Steel, chief executive officer at Equillium. “We have enrolled a total of 36 patients in the study, of which 13, or 36 percent, had very severe alopecia areata. These patients are in need of new treatments that may have an improved safety profile compared to recently approved JAK inhibitors. While the study remains ongoing, to date EQ101 has been well tolerated over the 24-week dosing period. We expect to announce top-line data in Q2 2024.” EQ101 Alopecia Areata Phase 2 Study Baseline Characteristics: 36 patients enrolled: 17 male and 19 female; 64% Caucasian Age range of 18 to 60 years (mean age 38.2 years) Disease severity of patients at enrollment as defined by Severity of ALopecia Tool (SALT): Mean SALT score of 76 17% Moderate (SALT score 35 to 49) 50% Severe (SALT score 50 to 94) 33% Very Severe (SALT score > 95%) 27 patients (75%) had been on previous treatments with 11 of those patients having history of oral treatments (including steroids, minoxidil, methotrexate, mycophenolate mofetil) and one patient having previous treatment with a systemic JAK inhibitor EQ102 & EQ302 “EQ102 is a first-in-class, bi-specific inhibitor of IL-15 and IL-21, two cytokines central to T and B cell activity, that exhibit biological synergy driving aggressive inflammatory responses in a number of gastrointestinal and skin diseases, highlighting the importance of dual inhibition,” said Steve Connelly, chief scientific officer at Equillium. “While EQ102 was generally well tolerated and demonstrated pharmacodynamic activity in the SAD/MAD portions of the study, the bioavailability of this initial formulation was lower than expected. Given our recent progress with EQ302, a potential first-in-class, second generation, orally delivered stapled peptide targeting IL-15 and IL-21, we intend to transition away from further developing EQ102, to advance EQ302 towards the clinic for the potential treatment of patients with gastrointestinal and skin diseases. Preclinical and translational data have demonstrated that EQ302 has increased potency compared to EQ102, is both stable and permeable in the gut, and can be further modified for optimal systemic or gut-restricted activity. Based on the superior product profile of EQ302, and the significant clinical and commercial advantages of orally delivered therapies in these disease settings, we believe advancing EQ302 is a better long-term strategy. This development also illustrates the utility and modularity of our multi-cytokine platform in generating novel, first-in-class therapeutic candidates.” 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 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 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 and EQ302 and the expected timeline for topline data for the EQ101 Phase 2 study, the plan to advance EQ302 into the clinic, the potential for EQ 302 to be a first-in-class therapeutic candidate, the potential benefits of EQ101 and EQ302, and the belief that advancing EQ302 is a better long-term strategy. 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; whether the advancement of EQ302 will be a better long-term strategy; Equillium’s ability to execute its plans and strategies; 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; changes in the competitive landscape; and uncertainties related to Equillium’s capital requirements. 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.

Itolizumab continues to show clinically meaningful response in highly proteinuric subjects At Week 28, 73% of subjects achieved >50% reduction in urine protein creatinine ratio (UPCR) Itolizumab demonstrated a favorable safety and tolerability pro > LA JOLLA, Calif.--(BUSINESS WIRE)-- Equillium, Inc. (Nasdaq: EQ), a clinical-stage biotechnology company focused on developing novel therapeutics to treat severe autoimmune and inflammatory disorders, today announced that data from the Type B portion of the EQUALISE study evaluating itolizumab in lupus nephritis patients was presented at ACR Convergence, the annual meeting of the American College of Rheumatology (ACR). The data presented by Dr. Kenneth Kalunian, Professor, Medicine, UCSD School of Medicine, highlights that subjects had high complete and partial response rates with rapid and deep reduction in urine protein creatinine ratio (UPCR) when itolizumab was added to mycophenolate mofetil (MMF) and corticosteroids. “This data presentation represents all but the last patient in the follow up period, and a preview of what will be delivered to Ono Pharmaceutical under the terms of our strategic partnership in early 2024,” said Bruce Steel, chief executive officer at Equillium. “It’s important that we saw both early and large reductions in proteinuria,” said Dr. Maple Fung, chief medical officer at Equillium. “Physicians are looking for a treatment that can safely and rapidly reduce the levels of proteinuria in patients, as this is historically associated with improved long-term outcomes. These results demonstrating high complete and partial response rates compare favorably to those observed in the phase three study of voclosporin, which had an overall response rate of seventy percent at six and twelve months of active treatment. Importantly, these results occurred in the setting of patients tapering their systemic corticosteroids, maintaining stable kidney function, or eGFR, and increasing serum albumin while on study.” The Type B portion of the EQUALISE study in patients with active proliferative LN (apLN) is evaluating the safety, tolerability and clinical activity of subcutaneous delivery of itolizumab. Patients must present with greater than 1 gram of proteinuria and have a recent kidney biopsy showing ISN/RPS class III or IV apLN to be eligible for the study. During the 24-week treatment period, patients receive a subcutaneous dose of 1.6 mg/kg every two weeks, with follow up out to 36 weeks. Consistent with standard of care, patients on study also receive 2-3 g/day of mycophenolate mofetil/mycophenolic acid (MMF/MPA), and patients may receive pulse systemic corticosteroids that are rapidly tapered. A total of 17 subjects have been enrolled in the study, with 15 subjects reaching Week 28 (4 weeks following the final dose, or the end of study (EOS)). Based on published guidelines for the management of lupus nephritis from the European League Against Rheumatism (EULAR) and European Renal Association-European Dialysis and Transplant Association (ERA-EDTA), clinical activity assessments in this study are focused on the change in UPCR from baseline; proportion of apLN subjects with a complete response (CR), defined as 50% or greater reduction in UPCR and less than 0.5-0.7 g/g; and proportion of subjects achieving a partial response (PR), defined as 50% or greater reduction in UPCR. Poster Presentation at the American College of Rheumatology Title: Clinical Safety and Efficacy Results from EQUALISE Type B: A Phase 1b Open-label Clinical Study of itolizumab, a Novel anti-CD6 Therapy, in Subjects with Active Proliferative Lupus Nephritis Author: Dr. Kenneth Kalunian, Professor, Medicine, UCSD School of Medicine Poster: 1496 Key findings from analysis of the Type B portion of the EQUALISE study in lupus nephritis: Subjects were highly proteinuric: baseline mean UPCR of 4.9 g/g Percent reduction from baseline in median spot UPCR is ~73% Clinically meaningful responses were observed: By week 28 (EOS): 6 of 15 (40%) subjects achieved CR (UPCR < 0.7 g/g) Additional 5 of 15 (33%) subjects achieved PR (UPCR > 50% reduction) There was a greater overall response rate (ORR) achieved in patients receiving itolizumab by 12 and 28 weeks than expected compared to the ORR in patients receiving standard of care alone using data generated from the Accelerating Medicines Partnership® (AMP) Lupus Network. Results are comparable to those observed in the Phase 3 AURORA1 study of voclosporin (ORR 70% at 6 and 12 months in active treatment). Consistent with the decline in UPCR overtime, subjects were able to taper their systemic corticosteroids over the course of the study. Itolizumab induced consistent pharmacodynamic responses in patients reducing the levels of cell surface CD6 on T cells, which is known to reduce T cell activity. Itolizumab treatment (over 6 months) was also associated with reductions in absolute lymphocyte counts (ALC), another known pharmacodynamic effect. As noted in other studies of drugs whose mechanism leads to reductions in ALC, such as the S1P modulators, the reduction in ALC observed here was not associated with increased rates of infection or other adverse clinical signals. 77% of TEAEs were assessed as mild (Grade 1) or moderate (Grade 2) by the investigators. Two subjects had at least one serious adverse event. The poster presentation is available on the Presentations page of Equillium’s website under the Lupus tab. About Systemic Lupus Erythematosus (SLE) & Lupus Nephritis (LN) SLE 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. LN is a serious complication of SLE, occurring in approximately 30% – 60% of individuals with SLE. LN involves the body’s own immune system attacking the kidneys, causing inflammation and significantly reducing kidney function over time. LN is associated with an increase in mortality compared with the general population and may lead to end-stage renal disease. About the EQUALISE Study The EQUALISE study is a two-part Phase 1b open-label proof-of-concept study of itolizumab in patients with SLE and LN. The Type A portion of the study was a multiple ascending-dose clinical study evaluating the safety and tolerability of subcutaneous delivery of itolizumab over a two-week treatment period in 35 patients with SLE. The Type B portion of the study, is evaluating the safety, tolerability and clinical activity of subcutaneous delivery of itolizumab dosed at 1.6 mg/kg every two weeks over a 24-week treatment period in patients with active proliferative LN. 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 targeting immuno-inflammatory pathways. EQ101: a tri-specific cytokine inhibitor that selectively targets IL-2, IL-9, and IL-15; currently under evaluation in a Phase 2 proof-of-concept clinical study of patients with alopecia areata. EQ102: a bi-specific cytokine inhibitor that selectively targets IL-15 and IL-21; currently under evaluation in a Phase 1 first-in-human clinical study to include healthy volunteers and celiac disease patients. EQ302: an orally-delivered, bi-specific inhibitor of IL-15 and IL-21; currently in preclinical development. 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 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. These statements include, but are not limited to, statements regarding Equillium’s plan to deliver full data package from its EQUALISE study to Ono Pharmaceuticals in early 2024, the potential benefits of itolizumab as a treatment for SLE and LN; and other statements regarding management’s intentions, plans, beliefs or expectations for the future. 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; 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; changes in the competitive landscape; and uncertainties related to Equillium’s capital requirements. 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.

$46.3 million in cash at the end of Q3 2023 expected to provide operating runway into 2025 $1.9 million of cash used in operating activities in Q3 2023 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 third quarter 2023 and provided corporate and clinical development updates. “The third quarter was focused on clinical execution and expanding education on our multi-cytokine platform and clinical programs ahead of initial data expected later this year,” said Bruce Steel, chief executive officer at Equillium. “We have completed enrollment in the Phase 1b EQUALISE study of itolizumab in patients with lupus nephritis and presented current data from that study at the annual meeting of the American Society of Nephrology earlier this month. We plan to provide the topline data to Ono in early 2024, which along with the interim review of the Phase 3 EQUATOR study in acute graft-versus-host disease, expected in 2024, comprise the data deliverables that will trigger Ono’s option decision. If Ono exercises its option, it would result in a payment of approximately $331 million and significantly extend Equillium’s cash runway. We also recently completed enrollment of the Phase 2 study of EQ101 in alopecia areata and expect to announce initial data from that study, as well as data from the SAD/MAD portion of the Phase 1 study of EQ102 before the end of the year. We believe Equillium is well positioned to create shareholder value with near-term milestones and a strong balance sheet that we expect to provide cash runway into 2025.” Highlights Since Beginning of Third Quarter: Hosted an Analyst & Investor Day featuring Arash Mostaghimi, MD, MPA, MPH, associate professor of dermatology at Harvard Medical School, that highlighted Equillium’s pipeline, the multi-cytokine platform and clinical-stage multi-cytokine inhibitors, with a focus on EQ101, currently in a Phase 2 clinical trial for moderate to severe alopecia areata that is now fully-enrolled. Announced a presentation at the 18th Annual Peptide Therapeutics Symposium highlighting EQ302, a second generation orally deliverable multi-cytokine inhibitor in development to target IL-15 and IL-21. The presentation outlined the origins of EQ302 from its parent peptide, EQ102, and data illustrating that adding hydrocarbon staples to a peptide can confer increased stability in the gastrointestinal tract while retaining its cytokine inhibitory properties​. Announced abstracts accepted for poster presentation at the annual meetings of the American Society of Nephrology (ASN) and the American College of Rheumatology (ACR). The abstracts highlight data from 17 Type B subjects in the Phase 1b EQUALISE study in highly proteinuric lupus nephritis patients that demonstrated that subjects had high complete and partial response rates with rapid and deep reduction in urine protein creatinine ratio (UPCR) when itolizumab was added to mycophenolate mofetil and corticosteroids. Anticipated Upcoming Milestones: EQ101: Phase 2 clinical study in subjects with alopecia areata – initial data anticipated in Q4 2023, topline data anticipated in mid-2024 EQ102: Phase 1 first-in-human study in healthy volunteers and subjects with celiac disease – single ascending dose (SAD)/multiple ascending dose (MAD) data anticipated in Q4 2023, celiac disease patient data anticipated in 2024 Itolizumab: EQUALISE lupus nephritis topline data anticipated to be delivered to Ono in early 2024, EQUATOR acute graft-versus-host disease (aGVHD) interim review anticipated in 2024 Third Quarter 2023 Financial Results Revenue for the third quarter of 2023 was $8.9 million, which was derived from itolizumab development funding from Ono Pharmaceutical Co, Ltd. (Ono) and amortization of the upfront payment from Ono. Research and development (R&D) expenses for the third quarter of 2023 were $9.0 million, compared with $8.8 million for the same period in 2022. The increase was primarily due to greater clinical development expenses driven by the EQUATOR, EQ101, and EQ102 clinical studies partially offset by lower costs for our other itolizumab (EQ001) studies, and further offset by a greater estimated Australian R&D tax incentive benefit, a decrease in non-clinical research expenses, and a decrease in employee compensation and benefits. General and administrative (G&A) expenses for the third quarter of 2023 were $3.5 million, compared with $4.5 million for the same period in 2022. The decrease was primarily driven by lower legal fees, overhead and employee compensation and benefits, partially offset by an increase in other professional fees. Net loss for the third quarter of 2023 was $3.7 million, or $(0.11) per basic and diluted share, compared with a net loss of $13.7 million, or $(0.40) per basic and diluted share for the same period in 2022. The decrease in net loss was primarily attributable to revenue related to the Ono partnership recognized in the third quarter of 2023, whereas no such revenue was recorded in the third quarter of 2022 as it was prior to the Ono partnership. Lower total operating expenses, lower interest expense, and greater interest income in the third quarter of 2023 also contributed to the decrease in net loss compared to the same period last year. Cash, cash equivalents and short-term investments totaled $46.3 million as of September 30, 2023, compared to $48.4 million as of June 30, 2023. Net cash used in operating activities in the third quarter of 2023 was $1.9 million. Equillium believes that its cash, cash equivalents and short-term investments as of September 30, 2023, including after giving effect to its stock repurchase program, will be sufficient to fund its operations into 2025. About Multi-Cytokine Platform and EQ101, EQ102 & 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 first-in-class, selective, tri-specific inhibitor of IL-2, IL-9, and IL-15 for intravenous and subcutaneous delivery; EQ102, a first-in-class, selective, bi-specific inhibitor of IL-15 and IL-21 for subcutaneous delivery; EQ302, in development as a 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 targeting immuno-inflammatory pathways. EQ101: a tri-specific cytokine inhibitor that selectively targets IL-2, IL-9, and IL-15; currently under evaluation in a Phase 2 proof-of-concept clinical study of patients with alopecia areata. EQ102: a bi-specific cytokine inhibitor that selectively targets IL-15 and IL-21; currently under evaluation in a Phase 1 first-in-human clinical study to include healthy volunteers and celiac disease patients. EQ302: an orally-delivered, bi-specific inhibitor of IL-15 and IL-21; currently in preclinical development. 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 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. Such statements include, but are not limited to statements regarding Equillium’s plans for developing EQ101, EQ102, EQ302 and itolizumab and the expected timing of results from clinical studies, anticipated upcoming milestones, the potential of Equillium to generate stockholder value, the potential for additional near-term cash income under the asset purchase agreement entered into between Equillium and Ono, the fluctuation of the foreign exchange rate, Equillium’s cash runway, and the potential benefits of Equillium’s product candidates. 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; the risk that initial and 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; whether Equillium is able to grow its business and increase stockholder value over time; risks related to Ono’s financial condition, willingness to continue to fund the development of itolizumab, and decision to exercise its option, if ever, to purchase itolizumab or terminate the 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) September 30, December 31, 2023 2022 Assets Cash, cash equivalents and short-term investments $ 46,306 $ 71,023 Accounts receivable 3,769 2,838 Prepaid expenses and other assets 4,228 3,369 Operating lease right-of-use assets 922 1,191 Total assets $ 55,225 $ 78,421 Current liabilities Accounts payable and other current liabilities $ 12,367 $ 17,338 Current portion of deferred revenue 15,832 14,700 Total current liabilities 28,199 32,038 Long-term deferred revenue 2,420 10,378 Other long-term liabilities 498 4,063 Total liabilities 31,117 46,479 Total stockholders' equity 24,108 31,942 Total liabilities and stockholders' equity $ 55,225 $ 78,421 Equillium, Inc. Condensed Consolidated Statements of Operations (In thousands, except share and per share data) (unaudited) Three Months Ended September 30, Nine Months Ended September 30, 2023 2022 2023 2022 Revenue $ 8,870 $ - $ 26,873 $ - Operating expenses: Research and development 8,974 8,771 27,855 29,022 Acquired in-process research and development - - - 23,049 General and administrative 3,519 4,466 10,340 12,047 Total operating expenses 12,493 13,237 38,195 64,118 Loss from operations (3,623 ) (13,237 ) (11,322 ) (64,118 ) Other income (expense), net 409 (418 ) 893 (1,083 ) Loss before income taxes (3,214 ) (13,655 ) (10,429 ) (65,201 ) Income tax expense 496 - 564 - Net loss $ (3,710 ) $ (13,655 ) $ (10,993 ) $ (65,201 ) Net loss per common share, basic and diluted $ (0.11 ) $ (0.40 ) $ (0.32 ) $ (1.95 ) Weighted-average number of common shares outstanding, basic and diluted 34,878,700 34,352,084 34,582,574 33,512,611 ____________________________ 1 Option exercise payment is denominated in Japanese yen (5 billion) and subject to currency exchange rates at the time of payment. View source version on businesswire.com: Contacts Investor & Media Contact Equillium, Inc. Michael Moore Vice President, Investor Relations Officer & Head of Corporate Communications 619-302-4431 ir@equilliumbio.com Source: Equillium, Inc. View this news release online at: