Equillium, Inc. (EQ) came out with a quarterly loss of $0.08 per share versus the Zacks Consensus Estimate of a loss of $0.17. This compares to loss of $0.11 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 52.94%. A quarter ago, it was expected that this company would post a loss of $0.17 per share when it actually produced a loss of $0.07, delivering a surprise of 58.82%.Over the last four quarters, the company has surpassed ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38692 EQUILLIUM, INC. (Exact name of registrant as specified in its charter) | Delaware | 82-1554746 | | --- | --- | | (State o ...

[Overview and Business Update](index=1&type=section&id=Overview%20and%20Business%20Update) Equillium achieved key clinical milestones for itolizumab and EQ101, with potential for significant milestone payments and cash runway extension [Q1 2024 Highlights & CEO Commentary](index=1&type=section&id=Q1%202024%20Highlights%20%26%20CEO%20Commentary) Equillium achieved positive Phase 1b itolizumab data and completed EQ101 Phase 2 enrollment, anticipating a significant Ono milestone - Announced positive topline data from the Phase 1b EQUALISE study of itolizumab in lupus nephritis patients, representing the first of two data sets for Ono Pharmaceutical's option exercise decision[1](index=1&type=chunk)[3](index=3&type=chunk) - Completed enrollment in the Phase 2 study of EQ101 for moderate to severe alopecia areata, with topline data anticipated in **Q2 2024**[2](index=2&type=chunk) - If Ono Pharmaceutical exercises its option to acquire rights to itolizumab, Equillium would receive an exercise payment of approximately **$32.1 million** (5 billion JPY) and remain eligible for up to **$101 million** in additional milestone payments[2](index=2&type=chunk)[4](index=4&type=chunk) [Anticipated Upcoming Milestones](index=1&type=section&id=Anticipated%20Upcoming%20Milestones) Key 2024 milestones include EQ101 Phase 2 data, itolizumab EQUATOR interim review, and Ono Pharmaceutical's option decision - Topline data from the Phase 2 clinical study of EQ101 in alopecia areata is anticipated in **Q2 2024**[5](index=5&type=chunk) - The interim review for the Phase 3 EQUATOR study of itolizumab in acute graft-versus-host disease is anticipated in **Q3 2024**[5](index=5&type=chunk) - Ono Pharmaceutical's option exercise decision for itolizumab is anticipated in the **second half of 2024**, following the final data deliverable from the EQUATOR interim review[2](index=2&type=chunk)[5](index=5&type=chunk) [First Quarter 2024 Financial Results](index=2&type=section&id=First%20Quarter%202024%20Financial%20Results) Equillium reported increased revenue and a narrowed net loss in Q1 2024, maintaining a cash runway into the second half of 2025 [Financial Performance Summary](index=2&type=section&id=Financial%20Performance%20Summary) Q1 2024 revenue increased to $10.7 million, with net loss narrowing to $2.7 million or $(0.08) per share Financial Performance Summary | Financial Metric | Q1 2024 | Q1 2023 | Change | | :--- | :--- | :--- | :--- | | **Revenue** | $10.7M | $8.9M | +20.2% | | **R&D Expenses** | $9.7M | $9.3M | +4.3% | | **G&A Expenses** | $3.7M | $3.7M | 0% | | **Net Loss** | ($2.7M) | ($3.9M) | -30.8% | | **Net Loss per Share** | ($0.08) | ($0.11) | -27.3% | - Revenue growth was driven by increased development funding (**$8.0 million** in Q1 2024 vs **$6.7 million** in Q1 2023) and amortization of the upfront payment (**$2.7 million** vs **$2.2 million**) from the Ono partnership[6](index=6&type=chunk) - The increase in R&D expenses was primarily due to higher chemistry, manufacturing and controls (CMC) activities for itolizumab and EQ101, and increased employee compensation[7](index=7&type=chunk) [Financial Position and Cash Runway](index=1&type=section&id=Financial%20Position%20and%20Cash%20Runway) Equillium ended Q1 2024 with $32.3 million in cash, sufficient to fund operations into the second half of 2025 Financial Position | Metric | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | Cash, cash equivalents and short-term investments | $32.3M | $40.9M | - The current cash balance is expected to provide a cash runway into the **second half of 2025**[1](index=1&type=chunk)[10](index=10&type=chunk) - Cash used in operating activities in Q1 2024 was **$8.8 million**, which included **$2.6 million** for annual employee bonuses[10](index=10&type=chunk) [Clinical Pipeline and Platforms](index=2&type=section&id=Clinical%20Pipeline%20and%20Platforms) Equillium's pipeline features the multi-cytokine platform with EQ101 and EQ302, alongside itolizumab, a first-in-class anti-CD6 monoclonal antibody [Multi-Cytokine Platform (EQ101 & EQ302)](index=2&type=section&id=Multi-Cytokine%20Platform%20%28EQ101%20%26%20EQ302%29) The multi-cytokine platform develops composite peptides to selectively block pathogenic cytokines, with EQ101 in Phase 2 and preclinical EQ302 - The proprietary platform generates rationally designed composite peptides that selectively block key cytokines (e.g., IL-2, IL-9, IL-15, IL-21) at the shared receptor level[11](index=11&type=chunk)[15](index=15&type=chunk) - EQ101 is a clinical-stage, first-in-class, selective, tri-specific inhibitor of IL-2, IL-9, and IL-15[12](index=12&type=chunk)[15](index=15&type=chunk) - EQ302 is a preclinical-stage, first-in-class, selective, bi-specific inhibitor of IL-15 and IL-21 designed for oral delivery[12](index=12&type=chunk)[15](index=15&type=chunk) [Itolizumab](index=2&type=section&id=Itolizumab) Itolizumab, a first-in-class anti-CD6 monoclonal antibody, is in Phase 3 for aGVHD and completed Phase 1b for lupus nephritis - Itolizumab is a clinical-stage, first-in-class anti-CD6 monoclonal antibody[14](index=14&type=chunk) - It selectively targets the CD6-ALCAM signaling pathway to downregulate pathogenic T effector cells while preserving T regulatory cells[14](index=14&type=chunk) - It is currently under evaluation in a Phase 3 clinical study for acute graft-versus-host disease (aGVHD) and has completed a Phase 1b study for lupus nephritis[15](index=15&type=chunk) [Financial Statements](index=4&type=section&id=Financial%20Statements) The financial statements detail Q1 2024 balance sheet changes and income statement performance, showing a narrowed net loss [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2024, total assets were $43.6 million and total liabilities were $22.5 million, reflecting a decrease from year-end 2023 Condensed Consolidated Balance Sheets (In thousands) | | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash, cash equivalents and short-term investments | $32,285 | $40,866 | | Total assets | $43,597 | $50,530 | | **Liabilities and Stockholders' Equity** | | | | Total current liabilities | $22,208 | $27,573 | | Total liabilities | $22,503 | $27,957 | | Total stockholders' equity | $21,094 | $22,573 | | Total liabilities and stockholders' equity | $43,597 | $50,530 | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Q1 2024 revenue was $10.7 million, with a net loss of $2.7 million or $(0.08) per share, an improvement from the prior year Condensed Consolidated Statements of Operations (In thousands, except per share data) | | Three Months Ended March 31, 2024 | Three Months Ended March 31, 2023 | | :--- | :--- | :--- | | Revenue | $10,689 | $8,879 | | Total operating expenses | $13,480 | $12,987 | | Loss from operations | $(2,791) | $(4,108) | | Net loss | $(2,734) | $(3,940) | | Net loss per common share, basic and diluted | $(0.08) | $(0.11) |

PART I [Business](index=7&type=section&id=Item%201.%20Business.) Equillium is a clinical-stage biotechnology company focused on developing therapeutics for severe immuno-inflammatory disorders, with a pipeline including EQ101, itolizumab (EQ001), and EQ302 - Equillium is a clinical-stage biotechnology company developing novel therapeutics for severe autoimmune and inflammatory disorders with high unmet medical need[23](index=23&type=chunk) Clinical Pipeline and Anticipated Milestones (in thousands) | Drug | Indication | Development Stage | Partners | Anticipated Milestones | | :--- | :--- | :--- | :--- | :--- | | **EQ101** (IL-2/9/15 inhibitor) | Alopecia Areata (IV) | Phase 2 | Worldwide rights | Q2 2024 topline data | | **EQ302** (oral IL-15/21 inhibitor) | Gastrointestinal Indications | Pre-Clinical | Worldwide rights | - | | **Itolizumab (EQ001)** (anti-CD6) | Acute Graft-Versus-Host Disease (aGVHD) | Phase 3 | ONO PHARMA & Biocon | Q3 2024 interim review | | **Itolizumab (EQ001)** (anti-CD6) | Systemic Lupus Erythematosus (SLE) / Lupus Nephritis (LN) | Phase 1b (Complete) | ONO PHARMA & Biocon | Topline data in the coming weeks | [Overview and Strategy](index=7&type=section&id=Overview%20and%20Strategy) The company's strategy is to become a leading, fully-integrated biotechnology firm focused on severe immuno-inflammatory disorders, advancing its clinical programs and expanding its pipeline - The company's primary strategic goals include: - Developing EQ101 for alopecia areata, with a Phase 2 proof-of-concept study underway - Advancing preclinical development of EQ302, an oral inhibitor for potential gastrointestinal diseases - Conducting a pivotal Phase 3 study (EQUATOR) of itolizumab (EQ001) for first-line aGVHD treatment - Advancing itolizumab (EQ001) for lupus nephritis and SLE following positive Phase 1b results - Opportunistically expanding the pipeline through discovery, acquisition, or in-licensing - Building a commercial infrastructure for potential product launches[28](index=28&type=chunk) [Partnerships](index=10&type=section&id=Partnerships) Equillium has key partnerships with Ono Pharmaceutical for itolizumab, involving an option agreement and R&D funding, and with Biocon for exclusive manufacturing and licensing - Equillium granted Ono Pharmaceutical an exclusive option to acquire its rights to itolizumab (EQ001) in the U.S., Canada, Australia, and New Zealand, with Ono making a one-time, upfront payment of **JPY 3.5 billion ($26.4 million)**[30](index=30&type=chunk) - If Ono exercises the option, Equillium will receive a payment of **JPY 5.0 billion (approx. $33.1 million)** and is eligible for up to **$101.4 million** in development and commercial milestones, with Ono funding all itolizumab R&D during the option period[31](index=31&type=chunk)[32](index=32&type=chunk) - Equillium licensed itolizumab (EQ001) from Biocon, which serves as the exclusive manufacturer, obligating Equillium to pay Biocon up to **$30 million** in regulatory milestones and **$565 million** in sales milestones, plus tiered royalties, which would transfer to Ono if it exercises its option[35](index=35&type=chunk)[36](index=36&type=chunk)[37](index=37&type=chunk) [Product Pipeline and Development](index=12&type=section&id=Product%20Pipeline%20and%20Development) Equillium's pipeline includes EQ101 in Phase 2 for alopecia areata, preclinical EQ302 for gastrointestinal diseases, and itolizumab (EQ001) in pivotal Phase 3 for aGVHD and Phase 1b for lupus nephritis - EQ101 is a first-in-class, tri-specific inhibitor of IL-2, IL-9, and IL-15, with a Phase 2 clinical study in alopecia areata ongoing and topline data expected in Q2 2024, alongside subcutaneous (SC) formulation development[42](index=42&type=chunk)[70](index=70&type=chunk) - EQ302 is a first-in-class, orally delivered, selective inhibitor of IL-15 and IL-21, targeting gastrointestinal diseases like celiac disease, currently in preclinical development[43](index=43&type=chunk)[50](index=50&type=chunk)[76](index=76&type=chunk) - Itolizumab (EQ001) is in a pivotal Phase 3 study (EQUATOR) for first-line aGVHD, with an interim analysis planned for Q3 2024 after approximately 100 subjects complete Day 29 assessments[87](index=87&type=chunk)[89](index=89&type=chunk) - The Phase 1b EQUALISE study of itolizumab in lupus nephritis (LN) showed clinically meaningful responses, with **73%** of subjects achieving greater than 50% reduction in proteinuria by week 28, supporting advancement to later-stage clinical studies[102](index=102&type=chunk)[105](index=105&type=chunk) [Intellectual Property](index=28&type=section&id=Intellectual%20Property) The company's intellectual property portfolio includes patents licensed from Biocon for itolizumab and wholly-owned patents for EQ101 and EQ302, with expiration dates ranging from 2028 to 2042 - The itolizumab patent portfolio is exclusively licensed from Biocon and includes issued patents in the U.S., Australia, Canada, and New Zealand, with key U.S. patents covering the antibody sequence expiring in 2028 and others extending to 2042[107](index=107&type=chunk)[108](index=108&type=chunk) - The composite peptide portfolio, acquired from Bioniz, covers EQ101 and EQ302, with the EQ101 patent family including issued patents in the U.S., Europe, and Japan expiring in 2032, and the EQ302 patent family having pending applications with expected expiration in 2038[111](index=111&type=chunk)[112](index=112&type=chunk)[115](index=115&type=chunk) - The company utilizes the Patent Cooperation Treaty (PCT) system to file international patent applications, allowing it to delay national filing expenses and evaluate patentability before incurring significant costs[117](index=117&type=chunk) [Competition](index=31&type=section&id=Competition) Equillium faces significant competition from major pharmaceutical and biotechnology companies across its therapeutic areas, including approved therapies and development programs for alopecia areata, celiac disease, aGVHD, and lupus nephritis - For Alopecia Areata (AA), competitors include companies with FDA-approved JAK inhibitors like Eli Lilly (baricitinib) and Pfizer (ritlecitinib), as well as others in development[127](index=127&type=chunk)[128](index=128&type=chunk) - For Celiac Disease, there are no FDA-approved therapies, but competitors with development programs include Amgen, Takeda, and Novartis[129](index=129&type=chunk) - For aGVHD, corticosteroids are the standard first-line treatment, and Incyte's ruxolitinib is approved for steroid-refractory (second-line) aGVHD[130](index=130&type=chunk) - For Lupus Nephritis (LN), two therapies are approved: GlaxoSmithKline's Benlysta and Aurinia Pharmaceuticals' Lupkynis, with other competitors including AstraZeneca and Novartis[132](index=132&type=chunk)[133](index=133&type=chunk) [Manufacturing, Sales and Marketing](index=33&type=section&id=Manufacturing%2C%20Sales%20and%20Marketing) Equillium relies on Contract Manufacturing Organizations (CMOs) for EQ101 and EQ302, with Biocon as the exclusive manufacturer for itolizumab, and plans to build or partner for future commercialization - The company relies on CMOs for the production of EQ101 and EQ302[135](index=135&type=chunk) - Biocon is the exclusive manufacturer for all clinical and commercial supply of itolizumab (EQ001), produced at its FDA-regulated facility in Bangalore, India[135](index=135&type=chunk) - The company currently has no commercial organization but intends to build internal sales and marketing capabilities or use third-party relationships for any approved products[134](index=134&type=chunk) [Government Regulation](index=33&type=section&id=Government%20Regulation) The company's operations are subject to extensive FDA regulation, including IND, clinical trial phases, and BLA submission, with itolizumab benefiting from Fast Track and Orphan Drug designations but also subject to OFAC regulations - The FDA approval process for biologics requires submitting an Investigational New Drug (IND) application before human trials, followed by Phase 1, 2, and 3 clinical studies, and submission of a Biologics License Application (BLA)[139](index=139&type=chunk)[140](index=140&type=chunk)[142](index=142&type=chunk) - The FDA has granted Fast Track designation for itolizumab (EQ001) for the treatment of aGVHD and LN, which may expedite development and review[85](index=85&type=chunk)[102](index=102&type=chunk)[151](index=151&type=chunk) - The company has received Orphan Drug designations from the FDA for itolizumab for the prevention and treatment of aGVHD, and for EQ101 for CTCL, which may provide seven years of market exclusivity if approved for those indications[49](index=49&type=chunk)[85](index=85&type=chunk)[157](index=157&type=chunk) - The development of itolizumab (EQ001) is subject to U.S. Treasury Department's OFAC regulations due to its Cuban-origin antibody sequence, with OFAC confirming authorization under a general license for Cuban-origin pharmaceuticals[199](index=199&type=chunk)[200](index=200&type=chunk)[404](index=404&type=chunk) [Risk Factors](index=52&type=section&id=Item%201A.%20Risk%20Factors.) The company faces significant risks, including a history of substantial financial losses, the need for additional capital, dependence on product candidates and third parties, and challenges in intellectual property protection and regulatory compliance - The company has a history of significant losses (**$13.3 million in 2023, $62.4 million in 2022**) and expects to incur losses for the foreseeable future, with an accumulated deficit of **$185.7 million** as of December 31, 2023[209](index=209&type=chunk)[210](index=210&type=chunk) - Substantial additional funding is required to complete the development of its product candidates, and failure to raise capital could force delays, reduction, or elimination of R&D programs[213](index=213&type=chunk)[215](index=215&type=chunk) - The business is highly dependent on the success of EQ101, EQ302, and itolizumab (EQ001), which may not obtain regulatory approval or be successfully commercialized[219](index=219&type=chunk) - The company is dependent on its partnership with Ono for funding the clinical development of itolizumab, and if Ono terminates the agreement or does not exercise its option, the company's business would be adversely impacted[241](index=241&type=chunk) - Reliance on third-party CMOs, particularly Biocon for itolizumab, presents risks related to manufacturing complexity, supply disruptions, and regulatory compliance[303](index=303&type=chunk) [Unresolved Staff Comments](index=110&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments.) The company reports no unresolved staff comments from the SEC - None[470](index=470&type=chunk) [Cybersecurity](index=110&type=section&id=Item%201C.%20Cybersecurity) The company manages cybersecurity risks through processes designed to identify, assess, and manage threats, overseen by an external IT consultant and reviewed by the Audit Committee - The company has implemented information security processes to identify, assess, and manage material cybersecurity risks[471](index=471&type=chunk) - An external Head of Information Technology consultant assists management in overseeing cybersecurity threats and risks[472](index=472&type=chunk) - The Audit Committee of the Board of Directors is responsible for reviewing cybersecurity risk assessment and management policies[477](index=477&type=chunk) [Properties](index=111&type=section&id=Item%202.%20Properties.) The company leases approximately 1,750 square feet for its headquarters in La Jolla, California, under a lease expiring in February 2027, along with additional office and laboratory space - The company leases its headquarters, office, and laboratory facilities in La Jolla, California, with lease agreements expiring between 2025 and 2027[482](index=482&type=chunk) [Legal Proceedings](index=111&type=section&id=Item%203.%20Legal%20Proceedings.) The company reports no legal proceedings - None[484](index=484&type=chunk) [Mine Safety Disclosures](index=111&type=section&id=Item%204.%20Mine%20Safety%20Disclosures.) This item is not applicable to the company - Not applicable[485](index=485&type=chunk) PART II [Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=112&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity%2C%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities.) The company's common stock trades on the Nasdaq Capital Market under "EQ", with approximately 50 stockholders, no history of cash dividends, and an authorized stock repurchase program of up to $7.5 million - The company's common stock trades on The Nasdaq Capital Market under the symbol "EQ"[488](index=488&type=chunk) - A stock repurchase program was authorized in July 2023 for up to **$7.5 million**, with **$0.3 million** worth of shares repurchased and **$7.2 million** remaining available as of December 31, 2023[493](index=493&type=chunk) - The company has never declared or paid cash dividends and does not intend to in the foreseeable future[490](index=490&type=chunk) [Reserved](index=112&type=section&id=Item%206.%20%5BReserved%5D) This item is reserved [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=113&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) For fiscal year 2023, Equillium reported a net loss of $13.3 million, a significant decrease from 2022, driven by increased revenue from the Ono partnership and the absence of a one-time R&D charge Results of Operations (in thousands) | | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | Change | | :--- | :--- | :--- | :--- | | **Revenue** | $36,084 | $15,759 | $20,325 | | Research and development | $37,039 | $37,547 | ($508) | | Acquired in-process R&D | $0 | $23,049 | ($23,049) | | General and administrative | $13,567 | $17,239 | ($3,672) | | **Net Loss** | **($13,335)** | **($62,428)** | **$49,093** | - The significant decrease in net loss for 2023 compared to 2022 was primarily driven by a **$23.0 million** acquired in-process R&D expense related to the Bioniz acquisition in 2022 that did not recur in 2023[533](index=533&type=chunk) - Revenue increased to **$36.1 million** in 2023 from **$15.8 million** in 2022, consisting of development funding (**$27.0 million**) and amortization of the upfront payment (**$9.1 million**) from the Ono Asset Purchase Agreement[532](index=532&type=chunk) - As of December 31, 2023, the company had **$40.9 million** in cash, cash equivalents, and short-term investments, which is expected to fund operations into the second half of 2025[511](index=511&type=chunk)[538](index=538&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=129&type=section&id=Item%207A.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) As a smaller reporting company, this disclosure is not required - Not required for smaller reporting companies[575](index=575&type=chunk) [Financial Statements and Supplementary Data](index=129&type=section&id=Item%208.%20Financial%20Statements%20and%20Supplementary%20Data.) This section indicates that the company's financial statements and supplementary data are included at the end of the Annual Report on Form 10-K, beginning on page F-1 - The required financial statements and supplementary data are included starting on page F-1 of the report[576](index=576&type=chunk) [Changes in and Disagreements With Accountants on Accounting and Financial Disclosure](index=129&type=section&id=Item%209.%20Changes%20in%20and%20Disagreements%20With%20Accountants%20on%20Accounting%20and%20Financial%20Disclosure.) The company reports no changes in or disagreements with its accountants on accounting and financial disclosure - None[577](index=577&type=chunk) [Controls and Procedures](index=129&type=section&id=Item%209A.%20Controls%20and%20Procedures.) Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective as of December 31, 2023, with no material changes to internal controls reported - Based on an evaluation as of December 31, 2023, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective[579](index=579&type=chunk) - Management assessed the effectiveness of internal control over financial reporting and concluded that it was effective as of December 31, 2023[581](index=581&type=chunk) [Other Information](index=129&type=section&id=Item%209B.%20Other%20Information.) During the fourth quarter of 2023, Christine Zedelmayer, the Chief Operating Officer, adopted a Rule 10b5-1 trading plan for the potential sale of 322,823 shares of common stock - On December 12, 2023, Chief Operating Officer Christine Zedelmayer adopted a Rule 10b5-1 trading plan for the sale of up to **322,823** shares of common stock, with an expiration date of December 12, 2024[584](index=584&type=chunk) [Disclosure Regarding Foreign Jurisdictions that Prevent Inspections](index=131&type=section&id=Item%209C.%20Disclosure%20Regarding%20Foreign%20Jurisdictions%20that%20Prevent%20Inspections.) This item is not applicable to the company - Not applicable[586](index=586&type=chunk) PART III [Directors, Executive Officers and Corporate Governance](index=132&type=section&id=Item%2010.%20Directors%2C%20Executive%20Officers%20and%20Corporate%20Governance.) The information required for this item is incorporated by reference from the company's definitive proxy statement for its 2024 annual meeting of stockholders - Information required by this item is incorporated by reference from the registrant's definitive Proxy Statement for its 2024 annual meeting of stockholders[588](index=588&type=chunk) [Executive Compensation](index=132&type=section&id=Item%2011.%20Executive%20Compensation.) The information required for this item regarding executive compensation is incorporated by reference from the company's definitive proxy statement for its 2024 annual meeting of stockholders - Information required by this item is incorporated by reference from the registrant's definitive Proxy Statement[590](index=590&type=chunk) [Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters](index=132&type=section&id=Item%2012.%20Security%20Ownership%20of%20Certain%20Beneficial%20Owners%20and%20Management%20and%20Related%20Stockholder%20Matters.) The information required for this item, concerning security ownership and equity compensation plans, is incorporated by reference from the company's definitive proxy statement for its 2024 annual meeting of stockholders - Information required by this item is incorporated by reference from the registrant's definitive Proxy Statement[591](index=591&type=chunk) [Certain Relationships and Related Transactions, and Director Independence](index=132&type=section&id=Item%2013.%20Certain%20Relationships%20and%20Related%20Transactions%2C%20and%20Director%20Independence.) The information required for this item, covering related party transactions and director independence, is incorporated by reference from the company's definitive proxy statement for its 2024 annual meeting of stockholders - Information required by this item is incorporated by reference from the registrant's definitive Proxy Statement[592](index=592&type=chunk) [Principal Accountant Fees and Services](index=132&type=section&id=Item%2014.%20Principal%20Accountant%20Fees%20and%20Services.) The information required for this item regarding principal accountant fees and services is incorporated by reference from the company's definitive proxy statement for its 2024 annual meeting of stockholders - Information required by this item is incorporated by reference from the registrant's definitive Proxy Statement[593](index=593&type=chunk) PART IV [Exhibits and Financial Statement Schedules](index=133&type=section&id=Item%2015.%20Exhibits%20and%20Financial%20Statement%20Schedules.) This section lists the exhibits filed with the Form 10-K, including material agreements and corporate governance documents, and indicates that consolidated financial statements are included beginning on page F-1 - The Consolidated Financial Statements of Equillium, Inc. are included after the Signatures page, beginning on page F-1[595](index=595&type=chunk) - A comprehensive list of exhibits filed with the report is provided, including material agreements, corporate governance documents, and required certifications[596](index=596&type=chunk) [Form 10-K Summary](index=136&type=section&id=Item%2016.%20Form%2010-K%20Summary.) The company reports that there is no Form 10-K summary - None[603](index=603&type=chunk) Financial Statements [Consolidated Balance Sheets](index=143&type=section&id=Consolidated%20Balance%20Sheets) As of December 31, 2023, Equillium reported total assets of $50.5 million, a decrease from 2022, primarily due to reduced cash and cash equivalents, with total liabilities and stockholders' equity also decreasing Consolidated Balance Sheet Data (in thousands) | | Dec 31, 2023 | Dec 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $23,216 | $59,107 | | Short-term investments | $17,650 | $11,916 | | **Total Current Assets** | **$49,349** | **$76,735** | | **Total Assets** | **$50,530** | **$78,421** | | **Liabilities & Stockholders' Equity** | | | | Total current liabilities | $27,573 | $32,038 | | Total liabilities | $27,957 | $46,479 | | Total stockholders' equity | $22,573 | $31,942 | | **Total Liabilities and Stockholders' Equity** | **$50,530** | **$78,421** | [Consolidated Statements of Operations and Comprehensive Loss](index=144&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) For the year ended December 31, 2023, the company reported revenue of $36.1 million and a net loss of $13.3 million, a significant reduction from the $62.4 million net loss in 2022 Consolidated Statement of Operations (in thousands) | | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Revenue | $36,084 | $15,759 | | Total operating expenses | $50,606 | $77,835 | | Loss from operations | ($14,522) | ($62,076) | | **Net loss** | **($13,335)** | **($62,428)** | | **Net loss per share, basic and diluted** | **($0.38)** | **($1.85)** | [Consolidated Statements of Cash Flows](index=146&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) For the year ended December 31, 2023, net cash used in operating activities was $21.8 million, resulting in a net decrease in cash and cash equivalents of $35.9 million, ending the year with $23.2 million Consolidated Statement of Cash Flows (in thousands) | | Year Ended Dec 31, 2023 | Year Ended Dec 31, 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($21,783) | ($8,733) | | Net cash (used in) provided by investing activities | ($4,762) | $18,684 | | Net cash used in financing activities | ($9,228) | ($1,215) | | **Net (decrease) increase in cash and cash equivalents** | **($35,891)** | **$8,741** | | **Cash and cash equivalents at end of period** | **$23,216** | **$59,107** |

Exhibit 99.1 Equillium Reports on Fourth Quarter and Full Year 2023 Financial Results and Corporate and Clinical Highlights $40.9 million cash balance at the end of 2023 expected to provide cash runway into 2H 2025 Completed enrollment of Phase 2 clinical study of EQ101 in alopecia areata: topline data expected in Q2 2024 Presented positive data from Phase 1b EQUALISE study of itolizumab in lupus nephritis patients at American Society of Nephrology (ASN) & American College of Rheumatology (ACR) meetings Ono ...

Wall Street has been roaring higher, driven by a solid earnings season, a resilient economy and a technology surge. Both the S&P 500 and Dow Jones are at all-time highs, while the tech-heavy Nasdaq Composite Index is just below its record peak.The gains have been broad-based across various segments and many stocks have more than doubled this year. We have highlighted five stocks that have a Zacks Rank #1 (Strong Buy) or 2 (Buy), a Momentum Score of B or better and saw positive earnings estimate revisions fo ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38692 EQUILLIUM, INC. (Exact name of registrant as specified in its charter) Delaware 82-1554746 (State or other jurisdicti ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38692 EQUILLIUM, INC. (Exact name of registrant as specified in its charter) Delaware 82-1554746 (State or other jurisdiction of ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-38692 EQUILLIUM, INC. (Exact name of registrant as specified in its charter) | Delaware | 82-1554746 | | --- | --- | | (State o ...

Corporate Presentation Forward-Looking Statements 2 | --- | --- | --- | --- | |-----------------------------------------------------------------------------|-------------------------------------|-------------------------|-----------------------------| | | | | | | Resetting Balance, | Novel | Assets | | | Restoring Health Leveraging a deep understanding of immunology | Multi-Cytokine Inhibitors | | Partnership for itolizumab | | to pioneer new therapies for severe autoimmune and inflammatory disorders | Mult ...