Financial Performance - For the nine months ended September 30, 2024, the company reported net losses of $2.3 million compared to $11.0 million for the same period in 2023, with an accumulated deficit of $188.0 million as of September 30, 2024[134]. - The company expects to continue incurring significant expenses and operating losses into the foreseeable future, with a focus on advancing research and development activities[134]. - The company had an accumulated deficit of $188.0 million as of September 30, 2024, and anticipates continuing to incur net losses for the foreseeable future[162]. - Cash used in operating activities for the nine months ended September 30, 2024, was $15.7 million, a slight decrease from $16.1 million in the same period of 2023[177]. - The company expects its cash and cash equivalents will be sufficient to fund operations into the fourth quarter of 2025, based on certain operational changes[168]. - The company reported a net loss of $2.3 million for the nine months ended, with an accumulated deficit of $188.0 million[194]. - The company expects to incur significant operating losses for the foreseeable future as it continues research and development activities and seeks regulatory approvals[196]. Revenue Generation - The company has not generated any revenue from therapeutic product sales, developmental milestones, or royalties to date, relying on development funding from Ono and recognition of deferred revenue from an upfront payment under the Asset Purchase Agreement[137]. - The company recognized revenue of $12.2 million and $36.7 million for the three and nine months ended September 30, 2024, respectively, compared to $8.9 million and $26.9 million for the same periods in 2023, reflecting a year-over-year increase of 37% and 36%[140][152]. - The company recognized $2.1 million in aggregate deferred revenue related to the Asset Purchase Agreement with Ono as of September 30, 2024[140]. Research and Development - The ongoing Phase 3 EQUATOR study for itolizumab (EQ001) is expected to accelerate its timeline to topline data by the first quarter of 2025, with reduced enrollment to approximately 150 patients[125]. - A positive recommendation was received from the Independent Data Safety Monitoring Committee to continue the EQUATOR study based on interim analysis of the first approximately 100 subjects[125]. - The company has completed a Phase 1b proof-of-concept clinical study of itolizumab in patients with systemic lupus erythematosus, announcing positive topline data in April 2024[127]. - The company anticipates that expenses may increase substantially as it advances research and development activities, including ongoing and future clinical development of itolizumab[145]. - The company has paused further development activities related to EQ101 and EQ302 due to financial constraints, pending the availability of additional funding[129]. - The company has initiated multiple clinical studies for itolizumab (EQ001), including a Phase 3 study for aGVHD, which is currently paused to save costs[218]. - The company has two active INDs with the FDA for itolizumab (EQ001) targeting aGVHD and LN, and additional INDs for EQ101 and EQ102 following the acquisition of Bioniz[218]. Funding and Capital Requirements - The company plans to finance its cash needs through a combination of equity offerings, debt financings, and collaboration agreements, but may face challenges in securing additional financing[136]. - The company entered into a 2023 ATM Facility with Jefferies LLC, allowing for the sale of shares up to $21.95 million, but no shares have been sold as of the report date[164]. - The company plans to pursue additional capital sources, including the 2023 ATM Facility, to address funding requirements following Ono's decision to let its option lapse[169]. - The company will require substantial additional funding to continue the development and commercialization of itolizumab (EQ001) and other product candidates[198]. - Future capital requirements will depend on various factors, including the progress and costs of ongoing clinical studies and the ability to implement significant expense reductions[204]. - The company may need to raise substantial additional capital to complete the development and commercialization of its product candidates, which could lead to dilution for existing shareholders[203]. Regulatory and Market Risks - The company is highly dependent on the successful development of itolizumab (EQ001) and may not obtain regulatory approval for its product candidates[189]. - The company has not yet obtained approval from the FDA or any other regulatory authority for any product, which may impede future approvals[243]. - Delays in obtaining regulatory approval could materially impair the company's ability to generate revenues and adversely affect its financial condition[244]. - The company faces challenges in enrolling patients for clinical studies, which could delay necessary regulatory approvals[252]. - The FDA may not accept data from clinical studies conducted outside the United States, which could delay development plans[269]. - Regulatory authorities may require additional studies or impose delays based on the safety and efficacy data submitted, affecting the approval timeline[241]. Competitive Landscape - The competitive landscape includes significant players like Pfizer Inc. and Eli Lilly and Company, which possess greater financial resources and expertise in R&D, manufacturing, and marketing[289]. - The company faces substantial competition in the biopharmaceutical market, which may result in competitors developing and commercializing products more quickly or effectively[286]. - The market acceptance of any approved product candidates will depend on factors such as efficacy, pricing, convenience, and marketing support[282]. Manufacturing and Supply Chain - The company relies on Biocon for the manufacturing of itolizumab (EQ001), and any disruptions in Biocon's operations could adversely affect the company's development and commercialization efforts[310]. - The company is dependent on contract research organizations (CROs) for clinical studies, and any failure by these third parties to meet obligations could delay regulatory approvals[311]. - Manufacturing of pharmaceutical products, especially biologics, is complex and dependent on third-party contract manufacturing organizations (CMOs), which poses risks to supply and approval timelines[306]. Intellectual Property - The company's success significantly depends on its ability to establish, maintain, and protect patents related to its proprietary technologies and product candidates, including itolizumab (EQ001) and others[319]. - The patent prosecution process is noted to be expensive and time-consuming, which may hinder the timely filing of necessary patent applications[320]. - There is a risk that the company or its partners may fail to identify patentable aspects of their research before it is too late to secure patent protection[320].

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].

Financial Performance - Revenue for Q2 2024 was $13.9 million, up from $9.1 million in Q2 2023, with development funding at $9.2 million and amortization of upfront payment at $4.7 million[3] - Net income for Q2 2024 was $0.5 million, or $0.01 per share, compared to a net loss of $3.3 million, or $(0.10) per share, in Q2 2023[4] - Revenue for June 2024 reached $13,853,000, a 52.1% increase from $9,124,000 in June 2023[12] - Net income for June 2024 was $468,000, a significant improvement from a net loss of $3,343,000 in June 2023[12] - Basic net income per share for June 2024 was $0.01, compared to a loss of $0.10 per share in June 2023[12] - Income (loss) before income taxes improved to $468,000 in June 2024 from a loss of $3,335,000 in June 2023[12] - The company reported a loss from operations of $100,000 in June 2024, compared to a loss of $3,591,000 in June 2023[12] Research and Development - R&D expenses for Q2 2024 were $10.8 million, compared to $9.6 million in Q2 2023, primarily due to increased CMC activities for itolizumab[4] - The company is advancing its multi-cytokine platform, targeting key cytokines to develop customized treatment strategies for autoimmune diseases[6] - Anticipated milestones include transitioning EQ101 to subcutaneous delivery and initiating a Phase 2b study in 2025, and starting Phase 1 study for EQ302 in the second half of 2025[3] - Positive topline data from Phase 2 study of EQ101 showed 29% of subjects with moderate to severe alopecia areata achieving SALT ≤ 20[2] Cash and Liabilities - Cash balance at the end of Q2 2024 was $33.3 million, a $1.0 million increase from Q1 2024[1] - Total liabilities as of June 30, 2024, were $20.4 million, down from $28.0 million at the end of 2023[11] - Equillium expects its cash reserves to fund operations for at least the next 12 months, assuming no further stock repurchases[5] Operating Expenses - Total operating expenses for June 2024 were $13,953,000, up 9.7% from $12,715,000 in June 2023[12] - Research and development expenses increased to $10,808,000 in June 2024, compared to $9,610,000 in June 2023, reflecting a 12.4% rise[12] - General and administrative expenses slightly increased to $3,145,000 in June 2024 from $3,105,000 in June 2023[12] - Total other income, net, rose to $568,000 in June 2024, up from $256,000 in June 2023[12] Shareholder Information - The weighted-average number of basic common shares outstanding increased to 35,292,035 in June 2024 from 34,449,769 in June 2023[12] - Ono Pharmaceutical has until the end of October 2024 to decide on acquiring rights to itolizumab, which could yield a one-time payment of approximately $35.0 million[2]

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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 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 or other jurisdiction of inco ...