What changed in this filing

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Item 2. Management’s Discussion and Analysis

2026-08-07 compared with 2026-05-15 · 100 added, 102 removed, 148 unchanged (58% of the section changed)

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Efzofitimod is a tRNA synthetase derived therapy that selectively modulates activated myeloid cells through neuropilin-2 (NRP2) to resolve aberrant inflammation without immune suppression and potentially prevent the progression of fibrosis.

ILDs are predominantly immune-mediated disorders that are characterized by chronic inflammation, which can lead to progressive fibrosis of the lung.

There are limited treatment options for ILD and there remains a high unmet medical need.

Sarcoidosis and systemic sclerosis (SSc, also known as scleroderma)-associated ILD (SSc-ILD) are two major forms of ILD.

Food and Drug Administration (FDA) has granted efzofitimod orphan drug designations for the treatment of sarcoidosis and for the treatment of SSc, and Fast Track designations for the

treatment of pulmonary sarcoidosis and for the treatment of SSc-ILD.

The European Commission has granted efzofitimod orphan drug designations for the treatment of sarcoidosis and for the treatment of SSc, based on the opinion of the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP).

In September 2025, we announced top-line data from a global Phase 3 randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of efzofitimod in patients with pulmonary sarcoidosis (the EFZO-FIT study).

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The study design incorporated a protocol guided steroid taper in the first 12 weeks of the study, followed by continued taper or rescue until week 48.

The study did not meet its primary endpoint of change from baseline in mean daily oral corticosteroid (OCS) dose at week 48.

The study did not meet its primary endpoint of change from baseline in mean daily oral corticosteroid (OCS)

dose at week 48.

The change from baseline in mean daily OCS dose reduced to an average of 2.79 mg for 5.0 mg/kg efzofitimod vs 3.52 mg for placebo (p=0.3313).

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In May 2026, we received the official meeting minutes from the FDA.

Based on feedback from the FDA, we plan to continue the development of efzofitimod in pulmonary sarcoidosis in a planned Phase 3 study in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease utilizing FVC as the primary endpoint of the study and the KSQ-Lung score as the key secondary endpoint.

Based on feedback from the FDA, we plan to continue the development of efzofitimod in pulmonary sarcoidosis in a new Phase 3 study in patients with chronic, symptomatic pulmonary sarcoidosis with restrictive lung disease utilizing FVC as the primary endpoint of the study and the KSQ-Lung score as the key secondary endpoint (the Planned Phase 3 Study).

We chose these endpoints based on the FDA’s indication that FVC and KSQ-Lung are direct measures of how patients suffering from pulmonary sarcoidosis function and feel, and we concluded FVC to be a more appropriate primary endpoint at this time pending further content validation work for KSQ-Lung as recommended by the FDA.

We determined the patient population for the study, those with restrictive lung disease, based on data from the EFZO-FIT study which included 44 patients with restrictive lung disease (defined as FVC percent predicted ≤ 80%) and showed a difference of 124 ml in change from baseline in FVC between restrictive patients treated with 5.0 mg/kg efzofitimod and placebo.

As part of our discussion with the FDA regarding the benefit risk profile for efzofitimod, we plan to increase the frequency of dosing of 5.0 mg/kg efzofitimod or placebo from once every four weeks in past trials to once every three weeks in this next trial.

We determined the patient population for the Planned Phase 3 Study, those with restrictive lung disease, based on data from the EFZO-FIT study which included 44 patients with restrictive lung disease (defined as FVC percent predicted ≤ 80%) and showed a difference of 124 ml in change from baseline in FVC between restrictive patients treated with 5.0 mg/kg efzofitimod and placebo.

We are choosing the dosing regimen based on the FDA’s acknowledgment of its reasonableness from a clinical pharmacology perspective, subject to inclusion of adequate safety monitoring and risk mitigation procedures.

We plan to include additional risk mitigation strategies, enhanced safety surveillance for the potential development of anti-synthetase syndrome and a data safety monitoring committee.

We plan to submit an investigational new drug (IND) application for this study in June 2026.

The Phase 3 trial is expected to be a global, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with moderate to severe pulmonary sarcoidosis.

The 54-week study will consist of two parallel cohorts randomized equally to either 5.0 mg/kg efzofitimod or placebo dosed intravenously once every 3 weeks for a total of 17 doses.

The study is intended to enroll up to approximately 372 patients with symptomatic pulmonary sarcoidosis with restrictive lung disease who are receiving a stable dose of ≤ 5.0 mg daily oral corticosteroid and/or a background immunosuppressant.

All background treatment will remain stable throughout the duration of the study.

The primary endpoint of the study will be change from baseline in FVC at week 48 and the key secondary endpoint will be change from baseline in the KSQ-Lung score at week 48.

This planned Phase 3 study and any potential need for additional clinical studies for efzofitimod in pulmonary sarcoidosis, will require a significant amount of additional time and resources to support approval.

In addition, it will require us to obtain additional capital through equity offerings or partnering to conduct such studies.

We believe efzofitimod has potential applications in the treatment of other ILDs, such as chronic hypersensitivity pneumonitis (CHP) and connective tissue disease related ILD (CTD-ILD), including SSc-ILD and rheumatoid arthritis-associated ILD.

As such, we designed a focused Phase 2 proof-of-concept clinical trial of efzofitimod (the EFZO-CONNECT study) in patients with SSc-ILD.

The EFZO-CONNECT study is a randomized, double-blind placebo-controlled proof-of-concept study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with SSc-ILD.

The Planned Phase 3 Study is expected to be a global, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of efzofitimod in patients with moderate to severe pulmonary sarcoidosis.

The Planned Phase 3 Study is a 54-week study and will consist of two parallel cohorts randomized equally to either 5.0 mg/kg efzofitimod or placebo dosed intravenously once every 3 weeks for a total of 17 doses.

The Planned Phase 3 Study is intended to enroll up to approximately 372 patients with symptomatic pulmonary sarcoidosis with restrictive lung disease who are receiving a stable dose of ≤ 5.0 mg daily oral corticosteroid and/or a background immunosuppressant.

All background treatment will remain stable throughout the duration of the Planned Phase 3 Study.

The primary endpoint of the Planned Phase 3 Study will be change from baseline in FVC at week 48 and the key secondary endpoint will be change from baseline in the KSQ-Lung score at week 48.

Our Phase 2 proof-of-concept clinical trial of efzofitimod (the EFZO-CONNECT study) is a randomized, double-blind placebo-controlled proof-of-concept study to evaluate the efficacy, safety and tolerability of efzofitimod in patients with SSc-ILD.

This is a 28-week study with three parallel cohorts randomized 2:2:1 to either 270 mg or 450 mg of efzofitimod or placebo dosed intravenously monthly for a total of six doses.

The study intends to enroll up to 25

patients at multiple centers in the United States.

The study intended to enroll up to 25 patients at multiple centers in the United States.

The objective of the study is to evaluate the efficacy of multiple doses of IV efzofitimod on pulmonary, cutaneous (limited or diffuse) and systemic manifestations in patients with SSc-ILD.

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In June 2025, we announced interim data from the study showing three out of four efzofitimod-treated diffuse SSc-ILD patients showed clinically important improvement based on the modified Rodnan Skin Score (mRSS) assessment at 12 weeks and that efzofitimod was generally well-tolerated at all doses.

We expect to complete enrollment of the study in the first half of 2026.

In January 2020, we entered into a collaboration and license agreement (Kyorin Agreement) with Kyorin for the development and commercialization of efzofitimod for the treatment of ILD in Japan.

Under the terms of the Kyorin Agreement, Kyorin received exclusive rights to develop and commercialize efzofitimod in Japan for all forms of ILD, and is obligated to fund all research, development, regulatory, marketing and commercialization activities in Japan.

We are responsible for supplying all drug product for Japan, as well as supporting development activities for efzofitimod.

In 2020, Kyorin conducted and funded a Phase 1 clinical trial of efzofitimod (known as KRP-R120 in Japan).

The Phase 1 clinical trial was a placebo-controlled clinical trial to evaluate the safety, pharmacokinetics (PK) and immunogenicity of efzofitimod in 32 healthy Japanese male volunteers.

Efzofitimod was observed to be generally well-tolerated with no drug-related serious adverse events, and PK findings were consistent with previous studies of efzofitimod.

Kyorin has also participated in the EFZO-FIT study as the local sponsor in Japan.

In February 2023, Kyorin dosed the first patient in Japan in the EFZO-FIT study which triggered a $10.0 million milestone payment to us.

To date, the Kyorin Agreement has generated $20.0 million in upfront and milestone payments to us.

On May 12, 2026, we received notice of termination of the Kyorin Agreement with Kyorin.

Kyorin elected to terminate the Kyorin Agreement without cause in accordance with the terms of the Kyorin Agreement, and the termination will become effective 90 days after the date of receipt of the notice of termination (the Termination Date).

Under the terms of the Kyorin Agreement, Kyorin received exclusive rights to develop and commercialize efzofitimod in Japan for all forms of interstitial lung disease and is obligated to fund all research, development, regulatory, marketing and commercialization activities in Japan until the Termination Date.

We are responsible for supplying all drug product for Japan, as well as supporting development activities for efzofitimod, until the Termination Date.

As a result of the termination of the Kyorin Agreement, we will not be entitled to receive any further milestone or other payments, including $155.0 million in the aggregate that would have been due upon achievement of certain development, regulatory and sales milestones, as well as tiered royalties on any net sales in Japan.

Both parties will also cease to have any development or commercialization obligations after the Termination Date and the licenses we granted to Kyorin pursuant to the Kyorin Agreement will cease to be in effect after the Termination Date.

Following the Termination Date, the rights to develop and commercialize efzofitimod in Japan for all forms of ILD will revert to us.

Consequently, we will hold the rights to develop and commercialize efzofitimod globally.

We have completed enrollment of the study with 23 patients.

Topline data are anticipated in the first quarter of 2027.

Discovery Platform

Using efzofitimod as a model, we have developed a process to advance novel tRNA synthetase domains from a concept to therapeutic candidate.

This process leverages our early discovery work as well as current scientific understanding of tRNA synthetase evolution, protein structure, gene splicing and tissue-specific regulation to identify potentially active protein domains.

This process leverages our early discovery work as well as current scientific understanding of tRNA synthetase

evolution, protein structure, gene splicing and tissue-specific regulation to identify potentially active protein domains.

Screening approaches are employed to identify target cells and extracellular receptors for these tRNA synthetase-derived proteins.

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tRNA Synthetase Candidates

Utilizing our novel approach, we have identified target receptors for domains of two additional tRNA synthetases, gaining insights into their potential biological activity in immunology and fibrosis.

Utilizing our novel approach, we have identified target receptors for domains of certain additional tRNA synthetases, gaining insights into their potential biological activity in immunology and fibrosis.

These fragments form the basis of our additional pipeline candidates.

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Early data suggest ATYR0101 exerts its antifibrotic effects by inducing apoptosis of myofibroblasts in a TGFβ dependent manner.

believe ATYR0101 may have broad therapeutic applications in multiple fibrotic diseases, such as pulmonary fibrosis, SSc, liver fibrosis and kidney fibrosis.

ATYR0750 is a fusion protein derived from a domain of alanyl-tRNA synthetase (AARS).

ATYR0750 is a novel ligand to fibroblast growth factor receptor 4 (FGFR4), which is involved in many cellular processes, including cell proliferation, differentiation, and tissue repair.

FGFR4 is known to play a role in diseases related to inflammation and fibrosis, particularly in the liver.

As a novel ligand, ATYR0750 interacts with FGFR4 in a differentiated way to other approaches targeting the receptor, which may lead to improved therapeutic benefit.

We believe ATYR0101 may have broad therapeutic applications in multiple fibrotic diseases, such as pulmonary fibrosis, SSc, liver fibrosis and kidney fibrosis.

We have initiated IND-enabling activities for ATYR0101 .

Corporate Restructuring and Program Prioritization

On August 7, 2026, our board of directors approved the implementation of a corporate restructuring and program prioritization plan (the Restructuring Plan) to streamline our operations, and conserve capital prior to the potential initiation of the Planned Phase 3 Study.

We submitted a protocol to our existing investigational new drug (IND) application for the Planned Phase 3 Study to the FDA in June 2026, and we await comments from the FDA on the protocol by the end of August 2026.

To conduct the Planned Phase 3 Study, in addition to implementing the Restructuring Plan, we will need to obtain additional capital through equity or debt offerings, grant funding, collaborations, strategic partnerships and/or licensing arrangements.

In connection with the Restructuring Plan, we committed to a reduction in our total workforce by approximately 60% to 20 full-time employees, and we estimate that the Restructuring Plan will reduce annualized operating expenses by approximately $13 million, beginning in the fourth quarter of 2026.

We began notifying affected employees on August 7, 2026 and expect the Restructuring Plan to be substantially completed in the second half of 2026.

We estimate that we will record charges of approximately $4.2 million for employee severance, employee health benefit obligations and other related termination benefits.

Severance payments are expected to be paid in full between August 2026 and September 2027, and we expect to incur the charges in the third quarter of 2026.

The charges that we expect to incur in connection with, or as a result of, the Restructuring Plan, are subject to a number of assumptions, and actual results may differ materially.

We may also incur other charges or cash expenditures not currently contemplated due to events that may occur as a result of, or associated with, the Restructuring Plan.

Liquidity and Capital Resources

We have incurred losses and negative cash flows from operations since our inception.

As of March 31, 2026, we had an accumulated deficit of $617.0 million, and we expect to continue to incur net losses for the foreseeable future.

As of March 31, 2026, we had cash, cash equivalents, restricted cash and available-for-sale investments of $68.3 million.

As of June 30, 2026, we had an accumulated deficit of $627.3 million, and we expect to continue to incur net losses for the foreseeable future.

As of June 30, 2026, we had cash, cash equivalents, restricted cash and available-for-sale investments of $58.9 million.

We believe that our current cash, cash equivalents, restricted cash and available-for-sale investments, will be sufficient to meet our material cash requirements from known contractual and other obligations for a period of at least one year from the date of this Quarterly Report.

In addition to the factors discussed under “Material Cash Requirements,” our ability to fund our longer-term operating needs, including the completion of a planned Phase 3 trial for efzofitimod in pulmonary sarcoidosis, will depend on our ability to raise additional funding through equity or debt offerings, grant funding, collaborations, strategic partnerships and/or licensing arrangements, and other factors, including those discussed in Part I, Item 1A.

In addition to the factors discussed under “Material Cash Requirements,” our ability to fund our longer-term operating needs, including the completion of the Planned Phase 3 Study for efzofitimod in pulmonary sarcoidosis, will depend on our ability to raise additional funding through equity or debt offerings, grant funding, collaborations, strategic partnerships and/or licensing arrangements, and other factors, including those discussed in Part II, Item 1A.

“Risk Factors—Risks related to our financial condition and need for additional capital—We will need to raise additional capital or enter into strategic partnering relationships to fund our operations.”

Sources of Cash

From our inception through March 31, 2026, we have financed our operations primarily through the sale of equity securities and convertible debt, venture debt, term loans and through license and collaboration agreement revenues.

In recent years, we have relied primarily on our “at-the-market” offering program (the Jefferies ATM Offering Program) implemented through our Open Market Sale Agreement SM with Jefferies LLC (Jefferies) for financing our activities.

From our inception through June 30, 2026, we have financed our operations primarily through the sale of equity securities and convertible debt, venture debt, term loans and through license and collaboration agreement revenues.

In recent years, we have relied primarily on our “at-the-market” offering program (the Jefferies ATM Offering Program) implemented through our Open Market Sale

Agreement SM with Jefferies LLC (Jefferies) for financing our activities.

Given ongoing volatility in capital markets generally, the price of our common stock has fluctuated materially since the start of 2025 and, since the announcement of top-line data from the EFZO-FIT study particularly, we have experienced a material decline in our stock price.

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Jefferies is entitled to a fixed commission rate of up to 3.0% of the gross sales proceeds of shares sold under the Jefferies ATM Offering Program.

We did not utilize the Jefferies ATM Offering Program during the three months ended March 31, 2026.

During the year ended December 31, 2025, we sold an aggregate of 13,887,177 shares of common stock at a weighted-average price of $4.94 per share for net proceeds of approximately $66.4 million under the Jefferies ATM Offering Program.

We did not utilize the Jefferies ATM Offering Program during the six months ended June 30, 2026.

The following table sets forth a summary of the net cash flow activity for each of the periods indicated (in thousands):

Three Months Ended March 31,

Six Months Ended June 30,

Net cash provided by (used in):

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Operating activities.

Net cash used in operating activities for the three months ended March 31, 2026 and 2025 was $12.5 million and $15.4 million, respectively.

The net cash used during the three months ended March 31, 2026 was primarily attributable to costs for efzofitimod development, which includes certain close-out costs relating to the EFZO-FIT study as well as ongoing costs for the EFZO-CONNECT study, as well as discovery costs for our preclinical product candidates.

The net cash used during the three months ended March 31, 2025 was primarily for efzofitimod development, including pre-commercialization activities and manufacturing costs incurred prior to the announcement of top-line data from the EFZO-FIT study.

We expect cash used in operating activities will fluctuate and be dependent upon our ability to obtain additional capital through equity offerings or partnering to enable us to conduct the planned Phase 3 study for efzofitimod in pulmonary sarcoidosis.

Net cash used in operating activities for the six months ended June 30, 2026 and 2025 was $21.9 million and $29.3 million, respectively.

The net cash used during the six months ended June 30, 2026 was primarily attributable to discovery costs for our preclinical product candidates and for efzofitimod development, which includes certain close-out costs relating to the EFZO-FIT study as well as ongoing costs for the EFZO-CONNECT study.

The net cash used during the six months ended June 30, 2025 was primarily for efzofitimod development, including pre-commercialization activities and manufacturing costs incurred prior to the announcement of top-line data from the EFZO-FIT study.

We expect cash used in operating activities will fluctuate and be dependent upon our ability to obtain additional capital through equity or debt offerings, grant funding, collaborations, strategic partnerships and/or licensing arrangements to enable us to conduct the Planned Phase 3 Study for efzofitimod in pulmonary sarcoidosis.

Investing activities.

Net cash provided by (used in) investing activities for the three months ended March 31, 2026 and 2025 was $11.5 million and $(4.4) million, respectively.

Net cash provided by (used in) investing activities for the six months ended June 30, 2026 and 2025 was $26.8 million and $(1.1) million, respectively.

The fluctuation in net cash provided by or used in investing activities resulted primarily from the timing differences in investment purchases, sales and maturities, and the fluctuation of our portfolio mix between cash equivalents and investment holdings.

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Financing activities.

Net cash (used in) provided by financing activities for the three months ended March 31, 2026 and 2025 was $(0.1) million and $18.6 million, respectively.

Net cash used in financing activities for the three months ended March 31, 2026 primarily consisted of principal payments on our financing lease agreement.

Net cash provided by financing activities for the three months ended March 31, 2025 primarily consisted of $18.8 million in proceeds from the issuance of common stock through the Jefferies ATM Offering Program, net of offering costs.

Net cash (used in) provided by financing activities for the six months ended June 30, 2026 and 2025 was $(0.3) million and $36.5 million, respectively.

Net cash used in financing activities for the six months ended June 30, 2026 primarily consisted of principal payments on our financing lease agreement.

Net cash provided by financing activities for the six months ended June 30, 2025 primarily consisted of $36.7 million in proceeds from the issuance of common stock through the Jefferies ATM Offering Program, net of offering costs.

Material Cash Requirements

To date, we have not generated any revenues from product sales.

Our expenses may increase in connection with the potential advancement of efzofitimod in clinical development, manufacturing, and regulatory activities, and the continuation of our research and development activities with respect to other potential therapies based on tRNA synthetase biology and the seeking of marketing approval for product candidates that we may develop.

Our expenses may increase in connection with the potential advancement of efzofitimod in clinical development, manufacturing, and regulatory activities.

In addition, if we obtain marketing approval for any of our product candidates, we expect to incur significant commercialization expenses related to product sales, marketing, manufacturing and distribution.

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Our future capital requirements are difficult to forecast and will depend on many factors.

Refer to Part I, Item 1A, "Risk Factors - Risks related to our financial condition and need for additional capital—We will need to raise additional capital or enter into strategic partnering relationships to fund our operations.” for a discussion of these factors.

Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity offerings, grant funding, collaborations, strategic partnerships and/or licensing arrangements, and when we are closer to commercialization of our product candidates potentially through debt financings.

Refer to Part II, Item 1A, "Risk Factors - Risks related to our financial condition and need for additional capital—We will need to raise additional capital or enter into strategic partnering relationships to fund our operations.” for a discussion of these factors.

Until such time, if ever, as we can generate substantial product revenues, we expect to finance our cash needs through a combination of equity or debt offerings, grant funding, collaborations, strategic partnerships and/or licensing arrangements.

To the extent we raise additional capital through the sale of equity, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of our common stockholders.

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If we are unable to raise additional funds, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market our product candidates even if we would otherwise prefer to develop and market such product candidates ourselves.

As of March 31, 2026, our material cash requirements from known contractual and other obligations consisted primarily of (i) an operating lease for our corporate headquarters and laboratory space, and (ii) our master financing lease agreement for various research and development and informational technology equipment.

As of June 30, 2026, our material cash requirements from known contractual and other obligations consisted primarily of (i) an operating lease for our corporate headquarters and laboratory space, and (ii) our master financing lease agreement for various research and development and informational technology equipment.

Corporate Headquarters Facility Lease

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The term of the lease (the Lease Term) commenced on March 20, 2023 (the Lease Commencement Date) and will continue for 124 months from the Lease Commencement Date.

We also have one option

to extend the Lease Term for five years.

We also have one option to extend the Lease Term for five years.

In April 2024, we entered into a lease amendment for additional common area amenities, effective as of June 2023.

The amendment increased the total rentable square feet from 23,696 rentable square feet to 24,866 rentable square feet.

We provided a $0.7 million security deposit in the form of a letter of credit which is included in restricted cash as of March 31, 2026.

We provided a $0.7 million security deposit in the form of a letter of credit which is included in restricted cash as of June 30, 2026.

Financing Lease

In April 2022, we entered into a financing lease to lease various research and development and information technology equipment over a 48-month term.

Financing lease liabilities total $0.7 million as of March 31, 2026.

Additionally, as of March 31, 2026, we have $1.1 million in cash collateral for the financing lease, and this amount is included in restricted cash.

We did not have any off-balance sheet arrangements as of March 31, 2026.

In April 2022, we entered into a master financing lease agreement.

Under this master agreement, we entered into various financing lease agreements from July 2022 through November 2023 to lease various research and development and information technology equipment over a 48-month term.

Financing lease liabilities total $0.6 million as of June 30, 2026.

Additionally, as of June 30, 2026, we have $0.8 million in cash collateral for the financing lease, and this amount is included in restricted cash.

We did not have any off-balance sheet arrangements as of June 30, 2026.

Financial Operations Overview

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was incorporated in the State of Delaware in September 2005.

The unaudited condensed consolidated financial statements in this Quarterly Report include our accounts and our 98% majority-owned subsidiary in Hong Kong, Pangu BioPharma, as of March 31, 2026.

The unaudited condensed consolidated financial statements in this Quarterly Report include our accounts and our 98% majority-owned subsidiary in Hong Kong, Pangu BioPharma, as of June 30, 2026.

All intercompany transactions and balances are eliminated in consolidation.

Revenue Recognition

In January 2020, we entered into the Kyorin Agreement with Kyorin for the development and commercialization of efzofitimod for the treatment of ILD in Japan.

Under the terms of the Kyorin Agreement, Kyorin received exclusive rights to develop and commercialize efzofitimod in Japan for all forms of ILD, and Kyorin is obligated to fund all research, development, regulatory, marketing and commercialization activities in Japan.

We are responsible for supplying all drug product for Japan, as well as supporting development activities for efzofitimod.

In 2020, Kyorin conducted and funded a Phase 1 clinical trial of efzofitimod (known as KRP-R120 in Japan).

The Phase 1 clinical trial, which was conducted and funded by Kyorin, was a placebo-controlled clinical trial to evaluate the safety, PK and immunogenicity of efzofitimod in 32 healthy Japanese male volunteers.

Efzofitimod was observed to be generally well-tolerated with no drug-related serious adverse events and PK findings were consistent with previous studies of efzofitimod.

Kyorin has also participated in the EFZO-FIT study as the local sponsor in Japan.

In February 2023, Kyorin dosed the first patient in Japan in the EFZO-FIT study which triggered a $10.0 million milestone payment to us.

To date, the Kyorin Agreement has generated $20.0 million in upfront and milestone payments to us.

As mentioned under the caption “Overview” above, we will cease to have any development or commercialization obligations under the Kyorin Agreement after the Termination Date, and we will not be entitled to receive any further milestone or other payments after the Termination Date.

Research and Development Expenses

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We primarily outsource our clinical trial administration to CROs, and we outsource our manufacturing of clinical trial materials to CDMOs.

These outsourced expenses are typically substantially higher than the expenses we incur on our other product candidates which are all currently in preclinical development.

As such, we separately track and report on the majority of our research and development expenses associated

with the advancement of efzofitimod.

For our candidates in preclinical development, the nature of the research and development expenses incurred to advance these candidates is primarily internal personnel and laboratory supply expenses.

These outsourced expenses are typically substantially higher than the expenses we incur on candidates in earlier stages of development.

As such, we separately track and report on the majority of our research and development expenses associated with the advancement of efzofitimod.

For our candidates in preclinical development, the nature of the research and development expenses incurred to advance these candidates is primarily internal personnel, laboratory supply expenses and IND-enabling activities.

We do not fully track or allocate these internal expenses between preclinical product candidates because the expenses can often be shared between candidates.

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Additionally, non-cash research and development expenses such as depreciation and stock-based compensation are not tracked or allocated between product candidates and are shared among all product candidates.

We anticipate that our research and development expenses will fluctuate and be dependent upon our ability to obtain additional capital through equity offerings or partnering to enable us to complete the planned Phase 3 study for efzofitimod in pulmonary sarcoidosis.

We anticipate that our research and development expenses will fluctuate and be dependent upon our ability to obtain additional capital through equity or debt offerings, grant funding, collaborations, strategic partnerships and/or licensing arrangements to enable us to conduct the Planned Phase 3 Study for efzofitimod in pulmonary sarcoidosis.

At this time, due to the inherently unpredictable nature of preclinical and clinical development and given the early stage of our programs, we are unable to estimate with any certainty the costs we will incur or the timelines we will require in the continued development of our product candidates.

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Results of Operations

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

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

Three Months Ended March 31,

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

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

Three Months Ended June 30,

Research and development expenses:

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Research and development expenses.

Research and development expenses were $7.3 million and $11.8 million for the three months ended March 31, 2026 and 2025, respectively.

Research and development expenses were $6.7 million and $15.4 million for the three months ended June 30, 2026 and 2025, respectively.

The decrease of $8.6 million was primarily driven by a reduction in efzofitimod expenses for the EFZO-FIT study since it was completed in September 2025 as well as decreased manufacturing costs due to the timing of certain manufacturing activities being completed.

Preclinical development and other shared research and development expenses increased by $0.8 million, and was primarily attributable to increase in discovery costs for our preclinical product candidates.

Non-cash expenses was consistent as compared to prior year period.

Preclinical development and other shared research and development expenses increased by $1.6 million, and was primarily attributable to increased discovery costs for our preclinical product candidates, including IND-enabling activities for our ATYR0101 preclinical candidate.

Non-cash expenses were consistent as compared to the prior year period.

General and administrative expenses.

General and administrative expenses were $4.1 million and $4.0 million for the three months ended March 31, 2026 and 2025, respectively.

Other general and administrative expenses were consistent as compared to prior year period.

Non-cash expenses increased by $0.1 million primarily due to increased non-cash stock-based compensation expenses.

General and administrative expenses were $4.1 million and $4.9 million for the three months ended June 30, 2026 and 2025, respectively.

The decrease of $0.8 million was attributable to pre-commercialization expenses incurred during the same period in the prior year ahead of the announcement of top-line data from the EFZO-FIT study.

Non-cash expenses decreased by $0.1 million primarily due to decreased non-cash stock-based compensation expenses.

We anticipate that our general and administrative expenses will decrease in the near term in conjunction with the implementation of our Restructuring Plan.

Other income (expense), net.

Other income (expense), net was $0.6 million and $0.9 million for the three months ended March 31, 2026 and 2025, respectively.

Other income (expense), net was $0.6 million and $0.8 million for the three months ended June 30, 2026 and 2025, respectively.

The change was primarily a result of lower interest rates and lower interest earned on lower cash balances as compared to the same period in the prior year.

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

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

Six Months Ended June 30,

Research and development expenses:

Efzofitimod expenses

Preclinical development and other shared research and development expenses

Non-cash expenses (depreciation and stock-based compensation)

Total research and development expenses

General and administrative expenses:

Other general and administrative expenses

Non-cash expenses (depreciation and stock-based compensation)

Total general and administrative expenses

Other income (expense), net

Research and development expenses.

Research and development expenses were $14.1 million and $27.2 million for the six months ended June 30, 2026 and 2025, respectively.

The decrease of $13.1 million was primarily driven by a reduction in efzofitimod expenses for the EFZO-FIT study since it was completed in September 2025 as well as decreased manufacturing costs due to the timing of certain manufacturing activities being completed.

Preclinical development and other shared research and development expenses increased by $2.4 million, and was primarily attributable to increased discovery costs for our preclinical product candidates, including IND-enabling activities for our ATYR0101 preclinical candidate.

Non-cash expenses were consistent as compared to the prior year period.

General and administrative expenses.

General and administrative expenses were $8.3 million and $8.9 million for the six months ended June 30, 2026 and 2025, respectively.

The decrease of $0.6 million was attributable to pre-commercialization expenses incurred during the same period in the prior year ahead of the announcement of top-line data from the EFZO-FIT study.

Non-cash expenses were consistent as compared to prior year period.

We anticipate that our general and administrative expenses will decrease in the near term in conjunction with the implementation of our Restructuring Plan.

Other income (expense), net.

Other income (expense), net was $1.2 million and $1.7 million for the six months ended June 30, 2026 and 2025, respectively.

The change was primarily a result of lower interest rates and lower interest earned on lower cash balances as compared to the same period in the prior year.

Recent Accounting Pronouncements

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What changed 10-Q

Item 2. Management’s Discussion and Analysis