Equillium, Inc.

Previous wording

We are a biotechnology innovator developing novel therapies to treat severe autoimmune and inflammatory disorders with the mission to develop life-changing therapeutics for patients. Our primary goal is to advance EQ504, our novel aryl hydrocarbon receptor, or AhR, modulator, into and through clinical development.

Current wording

We are a clinical-stage biotechnology innovator with a mission to develop highly impactful therapies to treat severe autoimmune and inflammatory disorders. Our primary goal is to advance EQ504, our novel aryl hydrocarbon receptor, or AhR, modulator, into and through clinical development.

Previous wording

As of March 31, 2026, we had $61.3 million in cash and cash equivalents. From inception through March 31, 2026, substantially all of our efforts have been focused on research, development and the advancement of our clinical and preclinical product candidates. We have not yet generated product sales and as a result have incurred significant operating losses and negative cash flows from operations. As a result, we had an accumulated deficit of $221.5 million as of March 31, 2026. We expect to incur additional losses in the future to conduct research and development for which we will need to raise additional capital to implement.

Current wording

As of June 30, 2026, we had $57.2 million in cash and cash equivalents. From inception through June 30, 2026, substantially all of our efforts have been focused on research, development and the advancement of our clinical and preclinical product candidates. We have not yet generated product sales and as a result have incurred significant operating losses and negative cash flows from operations. As a result, we had an accumulated deficit of $226.2 million as of June 30, 2026. We expect to incur additional losses in the future to conduct research and development for which we will need to raise additional capital to implement.

Previous wording

We intend to commence a Phase 1 proof-of-mechanism study for EQ504, a preclinical stage, novel AhR modulator, in mid-2026, with data expected to follow approximately six months thereafter; provided, however, we cannot provide any assurances that we will be able to obtain data within those time frames or that the data which may be obtained will be favorable to the further clinical development of EQ504. Modulation of AhR, in multiple translational models, has been shown to have a therapeutically beneficial impact inducing anti-inflammatory cells and cytokines while reducing proinflammatory cells and cytokines and improving intestinal barrier function and repair. We initially intend to develop EQ504 for the treatment of ulcerative colitis, or UC, and other gastrointestinal, or GI, diseases with potential indication expansion opportunities for the treatment of inflammatory lung diseases. We acquired the exclusive worldwide rights to EQ504 through the acquisition of Ariagen, Inc., or Ariagen, in October 2024.

Current wording

We intend to initiate a Phase 1 placebo-controlled proof-of-mechanism study for EQ504, a novel AhR modulator, in the fourth quarter of 2026, with data expected approximately six months thereafter; provided, however, we cannot provide any assurances that we will be able to obtain data within those time frames or that the data which may be obtained will be favorable to the further clinical development of EQ504. Modulation of AhR, in multiple translational models, has been shown to have a therapeutically beneficial impact inducing anti-inflammatory cells and cytokines while reducing proinflammatory cells and cytokines and improving intestinal barrier function and repair. We initially intend to develop EQ504 for the treatment of ulcerative colitis, or UC, and other gastrointestinal, or GI, diseases. In addition, we initiated IND-enabling development activities for EQ504 as a potential inhaled therapy to treat inflammatory lung diseases. We acquired the exclusive worldwide rights to EQ504 through the acquisition of Ariagen, Inc., or Ariagen, in October 2024.

Previous wording

EQ302 is a preclinical-stage, first-in-class, selective, bi-specific inhibitor of IL-15 and IL-21 formulated for oral delivery. Inhibiting IL-15 and IL-21 is believed to be an effective treatment approach for certain GI indications, including celiac disease. Preclinical and translational data has shown that EQ302 is a potent inhibitor of those two cytokines and is stable and permeable in the gut. Based on the unique mechanism of action of EQ302 and its product profile, including the advantage of oral delivery, we believe that EQ302 has the potential to be an attractive therapeutic option for GI diseases, such as celiac disease. We are evaluating further advancement of EQ302, including product manufacturing and toxicology studies capable of supporting a potential IND filing and a first-in-human clinical study.

Current wording

EQ302 is a preclinical-stage, first-in-class, selective, bi-specific inhibitor of IL-15 and IL-21 formulated for oral delivery. Inhibiting IL-15 and IL-21 is believed to be an effective treatment approach for certain GI indications, including celiac disease. Preclinical and translational data has shown that EQ302 is a potent inhibitor of those two cytokines and is stable and permeable in the gut. Based on the unique mechanism of action of EQ302 and its product profile, including the advantage of oral delivery, we believe that EQ302 has the potential to be an attractive therapeutic option for GI diseases, such as celiac disease. We initiated IND-enabling development activities for EQ302.

Previous wording

We have incurred losses since our inception. For the three months ended March 31, 2026 and 2025, our net losses were $5.3 million and $8.7 million, respectively. As of March 31, 2026, we had an accumulated deficit of $221.5 million. Substantially all of our operating losses resulted from expenses incurred in connection with our research and development activities, preclinical and clinical activities and general and administrative costs associated with our operations.

Current wording

We have incurred losses since our inception. For the six months ended June 30, 2026 and 2025, our net losses were $10.0 million and $14.4 million, respectively. As of June 30, 2026, we had an accumulated deficit of $226.2 million. Substantially all of our operating losses resulted from expenses incurred in connection with our research and development activities, preclinical and clinical activities and general and administrative costs associated with our operations.

Previous wording

We expect to continue to incur significant expenses and operating losses into the foreseeable future. We anticipate our expenses will increase substantially as we advance our research and development activities for EQ504, potentially pursue any future development of EQ302, potentially expand the indications for which we conduct clinical development of our product candidates, potentially acquire or develop new product candidates, including preclinical drug candidates identified through our multi-cytokine targeting drug discovery platform, seek regulatory approval for and potentially commercialize any approved product candidates, hire additional personnel, protect our intellectual property, and incur general corporate costs. We expect that our existing cash and cash equivalents as of March 31, 2026 will enable us to fund our operations into 2029.

Current wording

We expect to continue to incur significant expenses and operating losses into the foreseeable future. We anticipate our expenses will increase substantially as we advance our research and development activities for EQ504 and EQ302, potentially expand the indications for which we conduct clinical development of our product candidates, potentially acquire or develop new product candidates, including preclinical drug candidates identified through our multi-cytokine targeting drug discovery platform, seek regulatory approval for and potentially commercialize any approved product candidates, hire additional personnel, protect our intellectual property, and incur general corporate costs. We expect that our existing cash and cash equivalents as of June 30, 2026 will enable us to fund our operations into 2029.

Previous wording

We do not expect to generate any revenues from product sales unless and until we successfully complete development and obtain regulatory approval for EQ504, EQ302, or any future product candidate, which is unlikely to happen within the next 12 months, if ever. Until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through a combination of equity offerings, debt financings, and collaboration and license agreements. However, we may not be able to secure additional financing or enter into such other arrangements in a timely manner or on favorable terms, if at all. As a result of the conflict between Russia and Ukraine, the conflict in the Middle East, government shutdowns, bank failures, tariffs, inflationary pressures on the economy and monetary policy responses by government agencies and other macroeconomic factors, the global credit and financial markets have experienced extreme volatility, including from diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth and uncertainty about economic stability. If equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult to obtain, more costly and/or more dilutive. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and could force us to delay, reduce or terminate our research and development programs or other operations, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Current wording

We do not expect to generate any revenues from product sales unless and until we successfully complete development and obtain regulatory approval for EQ504, EQ302, or any future product candidate, which is unlikely to happen within the next 12 months, if ever. Until such time as we can generate significant revenue from sales of our product candidates, if ever, we expect to finance our cash needs through a combination of equity offerings, debt financings, and collaboration and license agreements. However, we may not be able to secure additional financing or enter into such other arrangements in a timely manner or on favorable terms, if at all. As a result of the conflict between Russia and Ukraine, the conflicts in the Middle East, government shutdowns, bank failures, tariffs, inflationary pressures on the economy and monetary policy responses by government agencies and other macroeconomic factors, the global credit and financial markets have experienced extreme volatility, including from diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth and uncertainty about economic stability. If equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult to obtain, more costly and/or more dilutive. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and could force us to delay, reduce or terminate our research and development programs or other operations, or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Previous wording

We plan to continue to incur substantial research and development expenses for the foreseeable future as we advance the development of EQ504, and potentially EQ302, potentially expand the number of indications for which we are developing those product candidates, and potentially acquire or develop new product candidates. The successful development of EQ504 and EQ302 is highly uncertain. At this time, due to the inherently unpredictable nature of preclinical and clinical development, we cannot reasonably estimate the nature, timing or costs of the efforts that will be necessary to complete the remainder of the development of our product candidates or the period, if any, in which material net cash inflows from the sales from our product candidates may commence. Clinical development timelines, the probability of success, and development costs can differ materially from expectations.

Current wording

We plan to continue to incur substantial research and development expenses for the foreseeable future as we advance the development of EQ504 and EQ302, potentially expand the number of indications for which we are developing those product candidates, and potentially acquire or develop new product candidates. The successful development of EQ504 and EQ302 is highly uncertain. At this time, due to the inherently unpredictable nature of preclinical and clinical development, we cannot reasonably estimate the nature, timing or costs of the efforts that will be necessary to complete the remainder of the development of our product candidates or the period, if any, in which material net cash inflows from the sales from our product candidates may commence. Clinical development timelines, the probability of success, and development costs can differ materially from expectations.

Previous wording

Interest income consists primarily of interest income earned on cash, cash equivalents and short-term investments, and is recognized when earned.

Current wording

Interest income consists primarily of interest income earned on cash and cash equivalents and is recognized when earned.

Previous wording

Comparison of the Three Months Ended March 31, 2026 and 2025

Current wording

Comparison of the Three and Six Months Ended June 30, 2026 and 2025

Previous wording

The following table sets forth our results of operations for the three months ended March 31, 2026 and 2025 (in thousands):

Current wording

The following table sets forth our results of operations for the three and six months ended June 30, 2026 and 2025 (in thousands):

Previous wording

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We separate our research and development costs into two broad categories: direct and indirect. Additionally, with respect to direct research and development expenses, we further divide expenses into the following product candidate categories: EQ504, EQ302, Itolizumab (EQ001), EQ101 and EQ102. Itolizumab (EQ001) includes sub-categories for the clinical studies associated with itolizumab (EQ001) including our EQUATOR, EQUALISE and ulcerative colitis study. For direct research and development expenses, we track specific project research and development expenses that are directly attributable to our preclinical and clinical development product candidates that have been selected for further development. Such direct research and development expenses include nonclinical and clinical trial activities, external expenses related to CMC and supply of drug product and consulting expenses.

Current wording

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. We separate our research and development costs into two broad categories: direct and indirect. Additionally, with respect to direct research and development expenses, we further divide expenses into the following product candidate categories: EQ504, EQ302, Itolizumab (EQ001) - EQUATOR and other assets. Research and development expenses associated with the other assets category were immaterial in all periods presented. For direct research and development expenses, we track specific project research and development expenses that are directly attributable to our preclinical and clinical development product candidates that have been selected for further development. Such direct research and development expenses include nonclinical and clinical trial activities, external expenses related to CMC and supply of drug product and consulting expenses.

Previous wording

Research and development expenses decreased by $2.9 million for the three months ended March 31, 2026. Direct external expenses decreased significantly for the three months ended March 31, 2026 compared to the same period in 2025 due to the wind down of our clinical studies in 2025 including lower clinical development and CMC expenses as well as lower consulting expenses primarily related to the wind down of our EQUATOR study. Indirect expenses decreased for the three months ended March 31, 2026 compared to the same period in 2025 driven by lower employee compensation and benefits due to lower headcount caused by the wind down of our clinical studies.

Current wording

Research and development expenses decreased by $1.3 million and $4.3 million for the three and six months ended June 30, 2026, respectively, compared to the same periods in 2025. Direct external expenses decreased significantly for the three and six months ended June 30, 2026 compared to the same periods in 2025 primarily due to the wind down of our EQUATOR study in 2025 including lower clinical development as well as lower consulting expenses. Indirect expenses decreased for the three and six months ended June 30, 2026 compared to the same periods in 2025 driven by lower employee compensation and benefits due primarily to lower headcount caused by the wind down of our EQUATOR study.

Previous wording

Interest income was $0.3 million and $0.2 million for the three months ended March 31, 2026 and 2025, respectively. The increase in interest income was primarily due to higher average cash and cash equivalents balances during the three months ended March 31, 2026 compared to the three months ended March 31, 2025.

Current wording

Interest income was $0.5 million and $0.8 million for the three and six months ended June 30, 2026, respectively, compared to $0.1 million and $0.3 million for the three and six months ended June 30, 2025, respectively. The increase in interest income was primarily due to higher average cash and cash equivalents balances during the three and six months ended June 30, 2026 compared to the same periods in 2025.

Previous wording

Other (expense) income, net was expense of $10,000 for the three months ended March 31, 2026, compared to income of $43,000 for the three months ended March 31, 2025. The change relates primarily to an increase in net foreign currency transaction unrealized losses during the three months ended March 31, 2026 compared to the three months ended March 31, 2025.

Current wording

Other (expense) income, net was other expense of $47,000 and $57,000 for the three and six months ended June 30, 2026, respectively, compared to other income of $0.4 million for each of the three and six months ended June 30, 2025, respectively. The change relates primarily to an increase in net foreign currency transaction unrealized losses during the three and six months ended June 30, 2026 compared to the same periods in 2025.

Previous wording

From inception through March 31, 2026, we have financed our operations primarily through the sale of equity and debt securities and income generated from an asset purchase agreement that terminated in 2024. As of March 31, 2026, we had an accumulated deficit of $221.5 million and anticipate that we will continue to incur net losses for the foreseeable future. As of March 31, 2026, we had $61.3 million in cash and cash equivalents.

Current wording

From inception through June 30, 2026, we have financed our operations primarily through the sale of equity and debt securities and income generated from an asset purchase agreement that terminated in 2024. As of June 30, 2026, we had an accumulated deficit of $226.2 million and anticipate that we will continue to incur net losses for the foreseeable future. As of June 30, 2026, we had $57.2 million in cash and cash equivalents.

Previous wording

There were no sales under the 2023 ATM Facility for the three months ended March 31, 2026. During the three months ended March 31, 2025, we sold an aggregate of 109,410 shares of common stock under the 2023 ATM Facility for gross proceeds of approximately $55,000. For the inception-to-date period ended March 31, 2026, we sold a total of 1,719,485 shares of common stock under the 2023 ATM Facility for gross proceeds of $1.0 million and net proceeds totaling $0.3 million, after deducting for issuance costs incurred inception-to-date of $0.7 million.

Current wording

During the three months ended June 30, 2025, there were no shares sold under the 2023 ATM Facility. During the six months ended June 30, 2025, there were 109,410 shares of common stock sold under the 2023 ATM Facility for gross proceeds of approximately $55,000. Issuance costs related to the 2023 ATM Facility totaled $0.5 million through June 30, 2025. During the three and six months ended June 30, 2026, there were no shares of common stock sold under the 2023 ATM Facility.

Previous wording

We expect our expenses to increase substantially as we advance our research and development activities, including continued development of our preclinical asset, EQ504, including potential expansion into additional indications and potentially resuming development of EQ302. We expect that our primary uses of capital will be for nonclinical research, clinical development, formulation development, CMC activities, product supply, potential acquisition of new products, legal and other regulatory compliance expenses, employee compensation and related expenses, insurance premiums, working capital and other general overhead costs.

Current wording

We expect our expenses to increase substantially as we advance our research and development activities, including development of our clinical and preclinical assets, EQ504 and EQ302, including potential expansion into additional indications. We expect that our primary uses of capital will be for nonclinical research, clinical development, formulation development, CMC activities, product supply, potential acquisition of new products, legal and other regulatory compliance expenses, employee compensation and related expenses, insurance premiums, working capital and other general overhead costs.

Previous wording

the initiation, progress, timing, costs and results of our planned or future nonclinical and clinical studies of EQ504 and EQ302 and other future product candidates, including as such activities may be adversely impacted by public health epidemics or outbreaks, the evolving conflict between Russia and Ukraine, the conflict in the Middle East, bank failures, tariffs and inflationary pressures on the economy;

Current wording

the initiation, progress, timing, costs and results of our planned or future nonclinical and clinical studies of EQ504 and EQ302 and other future product candidates, including as such activities may be adversely impacted by public health epidemics or outbreaks, the evolving conflict between Russia and Ukraine, the conflicts in the Middle East, bank failures, tariffs and inflationary pressures on the economy;

Previous wording

the cost, timing and outcome of regulatory review of any New Drug Application, or NDA, we may submit for our product candidates;

Current wording

the cost, timing and outcome with respect to any regulatory filing or submission including any New Drug Application, or NDA, that we may make for our product candidates;

Previous wording

the costs and timing of manufacturing EQ504 and other product candidates;

Current wording

the costs and timing of manufacturing EQ504, EQ302 and other product candidates;

Previous wording

the cost associated with commercializing EQ504 or any of our other product candidates, if approved for commercial sale.

Current wording

the cost associated with commercializing EQ504, EQ302 or any of our other product candidates, if approved for commercial sale.

Previous wording

Until such time as we can generate product revenues, if ever, we expect to finance our cash needs through a combination of equity offerings, debt financings, and collaboration and license agreements. The sale of additional equity or convertible debt could result in additional dilution to our stockholders and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. The incurrence of debt financing would result in debt service obligations and the governing documents would likely include operating and financing covenants that would restrict our operations. As a result of the conflict between Russia and Ukraine, the conflict in the Middle East, government shutdowns, bank failures, tariffs, inflationary pressures on the economy and monetary policy responses taken by government agencies and other macroeconomic factors, the global credit and financial markets have experienced extreme volatility, including diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth and uncertainty about economic stability. There can be no assurance that further deterioration in credit and financial markets and confidence in economic conditions will not occur. If equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult to obtain, more costly and/or more dilutive. If we raise additional funds through collaboration or license agreements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us and/or that may reduce the value of our common stock. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or other operations. Any of these actions could have a material effect on our business, financial condition and results of operations. We have experienced net losses and negative cash flows from operating activities since our inception and expect to continue to incur net losses into the foreseeable future. We had an accumulated deficit of $221.5 million as of March 31, 2026. We expect operating losses and negative cash flows to continue for at least the next several years as we incur costs related to the development of EQ504, EQ302 and any of our other product candidates.

Current wording

Until such time as we can generate product revenues, if ever, we expect to finance our cash needs through a combination of equity offerings, debt financings, and collaboration and license agreements. The sale of additional equity or convertible debt could result in additional dilution to our stockholders and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our existing common stockholders. The incurrence of debt financing would result in debt service obligations and the governing documents would likely include operating and financing covenants that would restrict our operations. As a result of the conflict between Russia and Ukraine, the conflicts in the Middle East, government shutdowns, bank failures, tariffs, inflationary pressures on the economy and monetary policy responses taken by government agencies and other macroeconomic factors, the global credit and financial markets have experienced extreme volatility, including diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth and uncertainty about economic stability. There can be no assurance that further deterioration in credit and financial markets and confidence in economic conditions will not occur. If equity and credit markets deteriorate, it may make any necessary debt or equity financing more difficult to obtain, more costly and/or more dilutive. If we raise additional funds through collaboration or license agreements, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates or grant licenses on terms that may not be favorable to us and/or that may reduce the value of our common stock. If we are unable to raise capital when needed or on attractive terms, we would be forced to delay, reduce or eliminate our research and development programs or other operations. Any of these actions could have a material effect on our business, financial condition and results of operations. We have experienced net losses and negative cash flows from operating activities since our inception and expect to continue to incur net losses into the foreseeable future. We had an accumulated deficit of $226.2 million as of June 30, 2026. We expect operating losses and negative cash flows to continue for at least the next several years as we incur costs related to the development of EQ504, EQ302 and any of our other product candidates.

Previous wording

During the three months ended March 31, 2026, cash used in operating activities was $4.3 million compared to $8.2 million during the three months ended March 31, 2025. Cash used in operating activities during the three months ended March 31, 2026 primarily related to our net loss of $5.3 million, adjusted for non-cash items of $1.0 million, primarily consisting of non-cash stock-based compensation expenses. Cash used in operating activities during three months ended March 31, 2025 primarily related to our net loss of $8.7 million, adjusted for non-cash items of $0.6 million, primarily consisting of non-cash stock-based compensation expenses, and net cash outflows from changes in other operating assets and liabilities of $0.1 million.

Current wording

During the six months ended June 30, 2026, cash used in operating activities was $8.4 million compared to $11.2 million during the six months ended June 30, 2025. Cash used in operating activities during the six months ended June 30, 2026 primarily related to our net loss of $10.0 million, adjusted for non-cash items of $2.1 million, primarily consisting of non-cash stock-based compensation expenses, and net cash outflows from changes in other operating assets and liabilities of $0.5 million. Cash used in operating activities during the six months ended June 30, 2025 primarily related to our net loss of $14.4 million, adjusted for non-cash items of $0.8 million, primarily consisting of non-cash stock-based compensation expenses, and net cash inflows from changes in other operating assets and liabilities of $2.4 million.

Previous wording

Net cash used in investing activities was approximately $3,000 during the three months ended March 31, 2026 related to purchases of property and equipment.

Current wording

Net cash used in investing activities was approximately $0.1 million during the six months ended June 30, 2026 related to purchases of property and equipment.

Previous wording

Net cash provided by investing activities was $4.5 million during the three months ended March 31, 2025 and primarily consisted of maturities of our short-term investments.

Current wording

Net cash provided by investing activities was $4.5 million during the six months ended June 30, 2025 and primarily consisted of maturities of our short-term investments.

Previous wording

Net cash provided by financing activities totaled $35.3 million during the three months ended March 31, 2026 and primarily consisted of net proceeds from the sale of shares under the March 2026 Private Placement transaction totaling $34.9 million and proceeds totaling $0.4 million from the exercise of stock options.

Current wording

Net cash provided by financing activities totaled $35.4 million during the six months ended June 30, 2026 and primarily consisted of net proceeds from the sale of shares under the March 2026 Private Placement transaction totaling $34.8 million and net proceeds totaling $0.6 million from the exercise of stock options.

Previous wording

Net cash provided by financing activities totaled $0.1 million during the three months ended March 31, 2025. We received net proceeds from the sale of shares under our 2023 ATM Facility totaling approximately $53,000. There were no sales of shares under the 2023 ATM Facility until March 2025. During the three months ended March 31, 2025, we received proceeds totaling $38,000 from the exercise of stock options.

Current wording

Net cash provided by financing activities totaled $0.1 million during the six months ended June 30, 2025. We received net proceeds from the sale of shares under our 2023 ATM Facility totaling approximately $37,000. During the six months ended June 30, 2025, we received proceeds totaling $38,000 from the exercise of stock options.