Core Viewpoint - Equillium, Inc. (EQ) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on the consensus measure of EPS estimates from sell-side analysts, reflecting the company's changing earnings picture [1][2]. - Changes in earnings estimates are strongly correlated with near-term stock price movements, largely due to institutional investors using these estimates to calculate fair value [4]. Recent Performance and Projections - For the fiscal year ending December 2024, Equillium is expected to earn -$0.02 per share, representing a 94.7% change from the previous year's reported number [8]. - Over the past three months, the Zacks Consensus Estimate for Equillium has increased by 26.9%, indicating a positive trend in earnings estimates [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks, which have generated an average annual return of +25% since 1988 [7]. - Equillium's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, suggesting potential for market-beating returns in the near term [10].

Group 1: Momentum Investing Overview - Momentum investing deviates from the traditional "buy low and sell high" strategy, focusing instead on "buying high and selling higher" to maximize returns in a shorter time frame [1] - Fast-moving trending stocks can be appealing, but determining the right entry point is challenging, as these stocks may lose momentum if their valuations exceed future growth potential [2] Group 2: Investment Strategy and Stock Selection - Investing in bargain stocks that have recently shown price momentum can be a safer approach. The Zacks Momentum Style Score is useful for identifying strong momentum stocks, while the 'Fast-Paced Momentum at a Bargain' screen helps find attractively priced fast-moving stocks [3] - Equillium, Inc. (EQ) is highlighted as a strong candidate, with a four-week price change of 22.3%, indicating growing investor interest [4] - EQ has demonstrated positive returns over a longer time frame, gaining 20.7% over the past 12 weeks, and has a beta of 1.79, suggesting it moves significantly more than the market [5] Group 3: Performance Metrics and Valuation - EQ has a Momentum Score of B, indicating a favorable time to invest, and an upward trend in earnings estimate revisions has earned it a Zacks Rank 2 (Buy) [6][7] - The stock is trading at a Price-to-Sales ratio of 0.66, suggesting it is undervalued, as investors pay only 66 cents for each dollar of sales [7] Group 4: Additional Investment Opportunities - Besides EQ, there are other stocks that meet the criteria of the 'Fast-Paced Momentum at a Bargain' screen, presenting further investment opportunities [8] - The Zacks Premium Screens offer over 45 different strategies tailored to various investing styles, aiding in stock selection [9]

Financial Performance - Revenue for Q3 2024 was $12.2 million, a 37% increase from $8.9 million in Q3 2023[3] - Net loss for Q3 2024 was approximately $7,000, significantly reduced from a net loss of $3.7 million in Q3 2023[6] - General and administrative expenses decreased to $3.3 million in Q3 2024 from $3.5 million in Q3 2023, driven by lower professional fees[5] Research and Development - Research and development expenses for Q3 2024 were $9.6 million, up from $9.0 million in Q3 2023, primarily due to increased CMC activities and employee compensation[4] - The company has enrolled over 150 patients in the Phase 3 EQUATOR study, with topline data expected in Q1 2025[2] - Anticipated topline data from the Phase 2 ulcerative colitis study is also expected in Q1 2025[2] Financial Position - Cash, cash equivalents, and short-term investments totaled $25.9 million as of September 30, 2024, down from $33.3 million as of June 30, 2024[7] - Total assets decreased to $34.5 million as of September 30, 2024, from $50.5 million as of December 31, 2023[11] - Total stockholders' equity increased to $23.2 million as of September 30, 2024, compared to $22.6 million as of December 31, 2023[11] Partnerships and Rights - The company retained rights to itolizumab following the end of the partnership with Ono Pharmaceutical[2]

Company Overview - Equillium, Inc. (EQ) is expected to report a year-over-year increase in earnings, with a projected EPS of $0.07, reflecting a change of +163.6% [3] - Revenues are anticipated to reach $36.35 million, which is an increase of 309.8% compared to the same quarter last year [3] Earnings Estimates and Revisions - The consensus EPS estimate has been revised 11.24% higher in the last 30 days, indicating a positive reassessment by analysts [4] - However, the Most Accurate Estimate for Equillium is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -514.29%, suggesting a bearish outlook from analysts [10] Earnings Surprise Prediction - The Zacks Earnings ESP model indicates that a positive or negative reading can predict the likelihood of an earnings beat, but the predictive power is significant only for positive readings [7][8] - Equillium's current Zacks Rank is 4 (Sell), which complicates the prediction of an earnings beat [10] Historical Performance - In the last reported quarter, Equillium had a surprise of +106.67%, posting earnings of $0.01 per share against an expected loss of $0.15 [11] - The company has beaten consensus EPS estimates in all of the last four quarters [12] Industry Comparison - Spero Therapeutics, another company in the Zacks Medical - Biomedical and Genetics industry, is expected to report a loss of $0.27 per share, indicating a year-over-year change of -1,450% [16] - Spero Therapeutics has an Earnings ESP of 107.55% and a Zacks Rank of 2 (Buy), suggesting a higher likelihood of beating the consensus EPS estimate [17]

分组1 - Equillium, Inc. reported quarterly earnings of $0.01 per share, exceeding the Zacks Consensus Estimate of a loss of $0.15 per share, representing an earnings surprise of 106.67% [1] - The company posted revenues of $13.85 million for the quarter ended June 2024, surpassing the Zacks Consensus Estimate by 69.98%, compared to revenues of $9.12 million a year ago [2] - Equillium has surpassed consensus EPS estimates and revenue estimates for the last four quarters [2] 分组2 - The stock has added about 1.5% since the beginning of the year, underperforming the S&P 500's gain of 9% [3] - The current consensus EPS estimate for the coming quarter is $0.43 on revenues of $36.35 million, while for the current fiscal year, it is -$0.12 on revenues of $41.09 million [7] - The Medical - Biomedical and Genetics industry is currently in the top 37% of Zacks industries, indicating a favorable outlook for stocks in this sector [8]

Revenue Generation - The company has not generated any revenues from product sales and does not expect to do so within the next 12 months[117]. - For the six months ended June 30, 2024, the company recognized $24.5 million in revenue under the Asset Purchase Agreement with Ono, compared to $18.0 million for the same period in 2023, representing a 36.1% increase[121][132]. - The company received a one-time upfront payment of approximately $26.4 million under the Asset Purchase Agreement with Ono, with potential additional payments of up to $101.4 million based on milestones[119]. Research and Development Expenses - Research and development expenses for the three months ended June 30, 2024, were $10.8 million, up from $9.6 million in the same period in 2023, reflecting a 12.5% increase[133]. - The company plans to substantially increase research and development expenses to advance the development of EQ101, EQ302, and itolizumab (EQ001)[124]. - Research and development expenses increased by $1.7 million for the six months ended June 30, 2024, compared to the same period in 2023, primarily due to a $1.9 million increase in CMC activities expenses[134]. Development Funding - Development funding recognized for the six months ended June 30, 2024, was $17.2 million, compared to $13.5 million for the same period in 2023, indicating a 27.4% increase[132]. - As of June 30, 2024, the company had received $53.1 million in development funding from Ono for itolizumab[142]. General and Administrative Expenses - General and administrative expenses are expected to increase due to expanding infrastructure and compliance costs associated with being a public company[126]. - General and administrative expenses remained relatively constant at $3.1 million for the three months and $6.9 million for the six months ended June 30, 2024, compared to $3.1 million and $6.8 million for the same periods in 2023[135]. Financial Condition - As of June 30, 2024, the company had an accumulated deficit of $188.0 million and $11.1 million in cash and cash equivalents, along with $22.2 million in short-term investments[139]. - The company anticipates challenges in securing additional financing due to macroeconomic factors, which could impact its financial condition and operations[117]. - If Ono does not exercise its option, the company anticipates needing to reduce cash burn by approximately $10 million between November 2024 and August 2025 to fund operations[146]. Interest Income - Interest income decreased to $0.4 million and $0.8 million for the three and six months ended June 30, 2024, respectively, down from $0.6 million and $1.3 million in the same periods of 2023[137]. Stock Repurchase Program - The stock repurchase program authorized by the board allows for repurchases of up to $7.5 million, with $0.3 million spent on repurchasing 298,385 shares as of June 30, 2024[144]. Option Period - The option period for Ono to exercise its option on itolizumab will expire on October 30, 2024, following the delivery of topline data and interim analysis results[120].

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 ...

Announced positive topline data from the Phase 1b EQUALISE study of itolizumab in lupus nephritis patients. Anticipated Upcoming Milestones: First Quarter 2024 Financial Results Exhibit 99.1 Equillium Reports First Quarter 2024 Financial Results and Provides Recent Clinical Highlights $32.3 million cash balance at the end of Q1 2024 expected to provide cash runway into 2H 2025 Announced positive topline data from Phase 1b EQUALISE study of itolizumab in lupus nephritis patients, representing the first of tw ...

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** |