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Spyre Therapeutics, Inc.

For the period ended Jun 30, 2026. Filed Aug 4, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Jun 30, 2026 · Filed Aug 4, 2026

SYRE$103.86+7.5%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-03-31; filed 2026-05-05.

0001636282-26-000050

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-06-30; filed 2026-08-04.

0001636282-26-000096

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 101 previous paragraphs and 104 current paragraphs.

50 unchanged; 33 reworded; 14 added; 16 removed; 2 previous and 7 current paragraphs rearranged.

Tables are not compared: 3 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (14)

Current report

Topline induction data from Part A of the SKYLINE trial in UC subjects were presented in April 2026 (SPY001) and June 2026 (SPY002). Baseline characteristics were consistent with expectations (Figure 3). SPY001 and SPY002 were well-tolerated with a safety profile consistent with in-class comparators (Figure 4). SPY001 and SPY002 achieved their respective primary endpoints, demonstrating a statistically significant reduction in the RHI score of 9.2 points and 10.7 points, respectively. Rates of key secondary endpoints of clinical remission and endoscopic improvement were clinically meaningful at 40% and 51%, respectively, for SPY001 and 33% and 42%, respectively, for SPY002 (Figure 5). The change in the modified Mayo Score from baseline at Week 12 for both SPY001 and SPY002 was -3.7, reflecting consistency across secondary endpoints. Topline induction data for SPY003 are expected in September 2026.

Current report

1 Hospitalization for exacerbation of UC in one subject, not drug-related.

Current report

2 Hospitalization for worsening heart failure in one subject with history of heart failure & atrial fibrillation who was later diagnosed with worsening aortic stenosis, not drug related.

Current report

As of June 30, 2026, Contingent Value Rights are no longer a critical accounting policy or estimate. We determined that our future payment obligations under the contingent value rights agreement (the "CVR Agreement") we entered into with Equiniti Trust Company LLC (f/k/a American Stock Transfer & Trust Company LLC) as rights agent in connection with the Asset Acquisition no longer qualify as derivatives under ASC 815, Derivatives and Hedging, as all contingencies have been resolved. Accordingly, we have measured the fair value of our CVR liability by discounting the estimated future payments to be made under the CVR Agreement using our weighted average cost of capital. The estimated value of the CVR consideration is based upon available information and certain assumptions which our management believes are reasonable under the circumstances. The ultimate payout under the CVRs may differ materially from the assumptions used in determining the fair value of the CVR consideration.

Current report

Gain on Sale of In-Process Research and Development Asset. During the three months ended June 30, 2026 and 2025, the Company recognized gains of $40.0 million and $10.0 million, respectively, upon the achievement of milestones related to the 2023 sale of the global rights to the legacy assets, pegzilarginase, to Immedica, which were triggered by the sale of the related priority review voucher (“PRV”) and a favorable reimbursement decision for pegzilarginase in Europe, respectively.

Current report

Interest Income. Interest income was $10.1 million and $5.9 million for the three months ended June 30, 2026 and 2025, respectively. The increase was primarily due to higher investment balances.

Current report

Research and Development Expenses. Research and development expenses increased by $44.1 million, or 54%, to $125.9 million for the six months ended June 30, 2026, from $81.8 million for the six months ended June 30, 2025. The increase was primarily driven by higher manufacturing expenses, clinical trial expenses, and compensation costs, partially offset by lower early-stage research and development.

Current report

General and Administrative Expenses. General and administrative expenses increased by $7.6 million, or 32%, to $31.4 million for the six months ended June 30, 2026, from $23.7 million for the six months ended June 30, 2025. The increase was primarily attributable to an increase in compensation costs due to an increase in general and administrative headcount.

Current report

Interest Income. Interest income was $17.0 million and $12.4 million for the six months ended June 30, 2026 and 2025, respectively. The increase was primarily due to higher investment balances.

Current report

Cash provided by financing activities for the six months ended June 30, 2025 was $0.9 million.
Removed paragraphs (16)

Previous report

SPY001 demonstrates similar potency and selectivity as synthesized vedolizumab in preclinicalin vitro models including surface plasmon residence and cellular adhesion assays. We initiated a first-in-human (“FIH”) Phase 1 trial for SPY001 in June 2024. The SPY001 Phase 1 trial was a double blind, placebo-controlled trial in healthy volunteers consisting of a single-ascending dose (“SAD”) component and a multi-ascending dose

Previous report

(“MAD”) component. The trial enrolled 56 healthy adult participants into five SAD cohorts and two MAD cohorts in the main portion of the trial. The primary endpoint was safety, with PK and anti-drug antibodies (“ADA”) serving as secondary endpoints. Additional cohorts were added to the trial to evaluate PK in healthy volunteers of various ethnicities to facilitate subsequent global clinical trials. The Phase 1 study is now complete.

Previous report

Interim results were initially presented in November 2024, with additional data presented in May 2025 with up to eight months of follow up. To date, SPY001 has demonstrated a favorable safety profile across all dose groups, a meaningfully differentiated PK profile supporting potential quarterly or twice annual maintenance dosing, and rapid, complete saturation of α4β7 receptors beyond six months with a single dose of 600mg. Based on these results, SPY001 was advanced into the SKYLINE Phase 2 platform clinical trial.

Previous report

Initial topline induction results from Part A of the SKYLINE trial in ulcerative colitis subjects were presented in April 2026. 43 subjects were dosed with SPY001 and 41 subjects completed the induction period. Baseline characteristics were consistent with expectations (Figure 4). SPY001 was well tolerated with a safety profile consistent with the α4β7 class. There were six subjects with treatment-emergent adverse events (TEAEs) during the induction treatment period, with one serious adverse event (SAE), deemed not drug-related. The most common AE (occurring in ≥ 2 subjects) was back pain (n=2) (Figure 5). SPY001 achieved the primary endpoint, demonstrating a statistically significant reduction in the RHI score of 9.2 points (p<0.0001). Rates of key secondary endpoints of clinical remission and endoscopic improvement were clinically meaningful at 40% and 51%, respectively (Figure 6).

Previous report

*Chest pain in a 68-year-old male with history of coronary artery disease and angina pectoris, type 2 diabetes mellitus, hypertension, and hypercholesterolemia who presented with chest pain. ECG and cardiac enzymes did not show signs of a myocardial infarction.

Previous report

SPY002 and SPY072 bind and inhibit TL1A with subnanomolar potency in preclinical cellular assays. We initiated FIH Phase 1 trials for SPY002 and SPY072 in the fourth quarter of 2024. The Phase 1 trials were each double blind, placebo-controlled evaluations in healthy volunteers, consisting of five SAD cohorts. Each trial enrolled 40 healthy adult participants across the five SAD cohorts in the main portion of the trial. The primary endpoint is safety, with PK and ADAs serving as secondary endpoints, and PD markers as exploratory endpoints. Phase 1 trial enrollment is complete.

Previous report

Phase 1 data were presented in June 2025 and October 2025, with up to 24-weeks of follow up. To date, SPY002 and SPY072 have demonstrated favorable safety profiles, meaningfully differentiated PK profiles supporting potential quarterly or twice annual maintenance dosing, and complete suppression of free TL1A through up to 20-24 weeks at single 100mg doses. Based on these results, SPY002 was advanced to the SKYLINE Phase 2 platform trial in UC subjects and SPY072 was advanced to the SKYWAY Phase 2 basket trial in RA, PsA, and axSpA subjects.

Previous report

We initiated a FIH trial in March 2025. The SPY003 Phase 1 trial is a double blind, placebo-controlled trial in healthy volunteers trial that enrolled 59 healthy adult participants into five SAD cohorts, one multiple dose (MD) cohort, and one Chinese ethnobridging cohort. The primary endpoint is safety, with PK and ADAs serving as secondary endpoints. Phase 1 trial enrollment is now complete.

Previous report

Interim Phase 1 data were disclosed in November 2025, and additional data were presented in February 2026 with up to 20 weeks of follow-up, demonstrating that SPY003 exhibited a favorable safety profile and a meaningfully differentiated PK profile supporting quarterly or twice annual maintenance dosing. Based on these results, SPY003 was advanced to the SKYLINE Phase 2 platform trial.

Previous report

Based on these preclinical data, in addition to our positive interim Phase 1 results for SPY001 and SPY002, SPY120 was advanced into Part B of the SKYLINE Phase 2 platform trial.

Previous report

Based on these preclinical data, in addition to our positive interim Phase 1 results for SPY001 and SPY003, SPY130 was advanced into Part B of the SKYLINE Phase 2 platform trial.

Previous report

Based on these preclinical data, in addition to our positive interim Phase 1 results for SPY002 and SPY003, SPY230 was advanced into Part B of the SKYLINE Phase 2 platform trial.

Previous report

Cash provided by financing activities for the three months ended March 31, 2025 was $0.1 million.
Reworded paragraphs (33)

Previous wording

We are a biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (“IBD”) and rheumatic diseases. Our pipeline includes extended half-life antibodies targeting α4β7, TL1A, and IL-23 in development as monotherapies and pair-wise combinations..

Current wording

We are a clinical stage biotechnology company committed to developing next-generation therapies that elevate the standard in immunology by delivering more complete disease control, greater durability, and a simpler treatment experience for patients. Our pipeline includes extended half-life antibodies targeting α4β7, TL1A, and IL-23 in development as monotherapies and pair-wise combinations.

Previous wording

Our goal is to develop next-generation therapeutics to redefine the standard of care for the treatment of IBD and other immune-mediated diseases, relying on three strategic pillars:

Current wording

Our goal is to develop next-generation therapeutics to redefine the standard of care for the treatment of inflammatory bowel disease (“IBD”) and other immune-mediated diseases, relying on three strategic pillars:

Previous wording

•Advancing a portfolio of next-generation monotherapies - novel antibody candidates engineered for optimized potency, selectivity, and pharmacokinetics (“PK”) against validated IBD targets

Current wording

•Advancing a portfolio of next-generation monotherapies - novel antibody candidates engineered for optimized potency, selectivity, and pharmacokinetics (“PK”) against validated targets

Previous wording

We are advancing a pipeline of monoclonal antibodies (“mAbs”) for the treatment of IBD and other immune-mediated diseases. The following table (Figure 1) summarizes our pipeline and development strategy, including our SKYLINE Phase 2 platform trial evaluating SPY001, SPY002, SPY003, and pairwise combinations thereof in subjects with moderately to severely active UC and our SKYWAY basket trial evaluating SPY072 in three rheumatic diseases: RA, PsA, and axSpA:

Current wording

We are advancing a pipeline of monoclonal antibodies (“mAbs”) for the treatment of IBD and other immune-mediated diseases. The following table (Figure 1) summarizes our pipeline and development strategy, including our SKYLINE Phase 2 platform trial evaluating SPY001, SPY002, SPY003, and pairwise combinations thereof in subjects with moderately to severely active ulcerative colitis (“UC”) and our SKYWAY basket trial evaluating SPY072 in three rheumatic diseases: RA, PsA, and axSpA:

Previous wording

In May 2025, we initiated our SKYLINE Phase 2 platform trial evaluating SPY001, SPY002, SPY003, as well as pairwise combinations thereof (six investigational agents in total), in subjects with moderately to severely active UC (Figure 2). The trial consists of two parts:

Current wording

In May 2025, we initiated our SKYLINE Phase 2 platform trial evaluating SPY001, SPY002 and SPY003, as well as pairwise combinations thereof (six investigational agents in total), in subjects with moderately to severely active UC (Figure 2). The trial consists of two parts:

Previous wording

•Part A: Open-label assessment of the safety and preliminary efficacy of a single dose level of each investigational monotherapy. Enrollment for Part A has completed, with initial SPY001 Part A topline induction data announced in April 2026, and initial topline data expected for SPY002 and SPY003 in mid-2026 and the third quarter of 2026, respectively.

Current wording

•Part A: Open-label assessment of the safety and preliminary efficacy of a single dose level of each investigational monotherapy. Enrollment for Part A has completed, with initial SPY001 and SPY002 Part A topline induction data announced in April 2026 and June 2026, respectively, and with SPY003 topline induction data expected in September 2026.

Previous wording

Figure 4. SPY001 disposition and baseline demographics from SKYLINE Part A Induction Topline

Current wording

Figure 3. SPY001 and SPY002 baseline demographics from SKYLINE Part A Induction Topline

Previous wording

Figure 5. SPY001 safety summary from SKYLINE Part A Induction Topline

Current wording

Figure 4. SPY001 and SPY002 safety summary from SKYLINE Part A Induction Topline

Previous wording

Figure 6. SPY001 efficacy summary from SKYLINE Part A Induction Topline

Current wording

Figure 5. SPY001 and SPY002 efficacy summary from SKYLINE Part A Induction Topline

Previous wording

Primary endpoint of ΔRHI was analyzed using per protocol analysis set and t-test was applied to test against the null hypothesis of ΔRHI =0 (N=41); Secondary endpoints including Clinical Remission and Endoscopic Improvement rates were analyzed using full analysis set (N=43).

Current wording

Primary endpoint of ΔRHI was analyzed using per protocol analysis set and t-test was applied to test against the null hypothesis of ΔRHI=0; Secondary endpoints including Clinical Remission and Endoscopic Improvement rates were analyzed using full analysis set.

Previous wording

In September 2025, we initiated our SKYWAY Phase 2 randomized and placebo-controlled basket trial of SPY072 in subjects with moderately to severely active RA, PsA, or axSpA (Figure 3). The trial consists of three sub-studies:

Current wording

In September 2025, we initiated our SKYWAY Phase 2 randomized and placebo-controlled basket trial of SPY072 in subjects with moderately to severely active RA, PsA, or axSpA (Figure 6). The trial consists of three sub-studies, all of which have completed enrollment on or ahead of schedule:

Previous wording

•RA sub-study: Double-blind, placebo-controlled safety and efficacy study of two dose levels of SPY072 at Week 12 with open-label follow-up through Week 36. This sub-study has completed enrollment ahead of schedule and topline proof-of-concept data are expected in the third quarter of 2026.

Current wording

•RA sub-study: Double-blind, placebo-controlled safety and efficacy study of two dose levels of SPY072 at Week 12 with open-label follow-up through Week 36. Topline proof-of-concept data are expected in September 2026.

Previous wording

•PsA sub-study: Double-blind, placebo-controlled safety and efficacy study of a single dose level of SPY072 at Week 16 with open-label follow-up through Week 40. Enrollment continues in this sub-study and topline proof-of-concept data are expected in the fourth quarter of 2026.

Current wording

•PsA sub-study: Double-blind, placebo-controlled safety and efficacy study of a single dose level of SPY072 at Week 16 with open-label follow-up through Week 40. Topline proof-of-concept data are expected in the fourth quarter of 2026.

Previous wording

•axSpA sub-study: Double-blind, placebo-controlled safety and efficacy study of a single dose level of SPY072 at Week 16 with open-label follow-up through Week 40. Enrollment continues in this sub-study and topline proof-of-concept data are expected in the fourth quarter of 2026.

Current wording

•axSpA sub-study: Double-blind, placebo-controlled safety and efficacy study of a single dose level of SPY072 at Week 16 with open-label follow-up through Week 40. Topline proof-of-concept data are expected in the fourth quarter of 2026.

Previous wording

SPY001 is a highly potent, highly selective, and humanized monoclonal immunoglobulin G1 investigational antibody designed to bind selectively to the α4β7 integrin being developed for the treatment of IBD (UC and CD). The α4β7 integrin is a protein found on the surface of immune cells. This integrin regulates the migration of immune cells to the gut where they contribute to the inflammatory process in IBD. By selectively binding to the α4β7 integrin, SPY001 is designed to prevent the interaction of these immune cells with MAdCAM-1, a molecule expressed on endothelial cells lining the blood vessels in the gut. By blocking the interaction between α4β7 integrin and MAdCAM-1, SPY001 aims to reduce the recruitment of immune cells to the gut, leading to a decrease in inflammation. Since it specifically targets the gut immune system, SPY001 is designed to minimize systemic immunosuppressive effects unrelated to IBD pathology.

Current wording

SPY001 is a highly potent, highly selective, and humanized monoclonal immunoglobulin G1 investigational antibody designed to bind selectively to the α4β7 integrin being developed for the treatment of IBD (UC and Crohn’s Disease (“CD”)). The α4β7 integrin is a protein found on the surface of immune cells. This integrin regulates the migration of immune cells to the gut where they contribute to the inflammatory process in IBD. By selectively binding to the α4β7 integrin, SPY001 is designed to prevent the interaction of these immune cells with MAdCAM-1, a molecule expressed on endothelial cells lining the blood vessels in the gut. By blocking the interaction between α4β7 integrin and MAdCAM-1, SPY001 aims to reduce the recruitment of immune cells to the gut, leading to a decrease in inflammation. Since it specifically targets the gut immune system, SPY001 is designed to minimize systemic immunosuppressive effects unrelated to IBD pathology.

Previous wording

In October 2024, we presented preclinical data, demonstrating that anti-IL-23 and anti-TL1A have a synergistic effect on promoting IL-17 secretion from human and mouse cells, and that the combination of anti-IL-23 and anti-TL1A suppressed IL-17 secretion more effectively than either agent alone. In March and October 2025, we presented additional preclinical data, demonstrating that combinations resulted in superior in vivo biological activity relative to either monotherapy in mouse TNBS model. In addition, combination toxicology studies have been completed with no drug-related adverse findings observed.

Current wording

In October 2024, we presented preclinical data, demonstrating that anti-IL-23 and anti-TL1A have a synergistic effect on promoting IL-17 secretion from human and mouse cells, and that the combination of anti-IL-23 and anti-TL1A suppressed IL-17 secretion more effectively than either agent alone. In March and October

Previous wording

On July 12, 2023, December 14, 2023 and June 5, 2024, we exercised our Option available under the Paragon Agreement with respect to the SPY001, SPY002 and SPY003 research programs, respectively. In May 2024, we signed license agreements with Paragon for rights to royalty-bearing, world-wide, exclusive licenses to develop, manufacture, commercialize or otherwise exploit certain antibodies and products targeting ɑ4β7 integrin (SPY001 program) (the “SPY001 License Agreement”) and TL1A (SPY002 and SPY072 programs) (the “SPY002 and SPY072 License Agreement”) and, in October 2024, we signed a license agreement for rights to a royalty-bearing, world-wide, exclusive license to develop, manufacture, commercialize or otherwise exploit certain antibodies and products targeting IL-23 (SPY003 program) (the “SPY003 License Agreement” and, together with the SPY001 License Agreement and the SPY002 and SPY072 License Agreement, the “License Agreements”) in the field of IBD. The SPY003 License Agreement was subsequently amended and restated in February 2025. The Option with respect to one additional program remains unexercised under the Paragon Agreement.

Current wording

On July 12, 2023, December 14, 2023 and June 5, 2024, we exercised our Option available under the Paragon Agreement with respect to the SPY001, SPY002 and SPY003 research programs, respectively. In May 2024, we signed license agreements with Paragon for rights to royalty-bearing, world-wide, exclusive licenses to develop, manufacture, commercialize or otherwise exploit certain antibodies and products targeting ɑ4β7 integrin (SPY001 program) (the “SPY001 License Agreement”) and TL1A (SPY002 and SPY072 programs) (the “SPY002 and SPY072 License Agreement”) and, in October 2024, we signed a license agreement for rights to a royalty-bearing, world-wide, exclusive license to develop, manufacture, commercialize or otherwise exploit certain antibodies and products targeting IL-23 (SPY003 program) (the “SPY003 License Agreement” and, together with the SPY001 License Agreement and the SPY002 and SPY072 License Agreement, the “License Agreements”) in the field of IBD. The SPY003 License Agreement was subsequently amended and restated in February 2025 and further amended in May 2026 to expand the definition of “Field” to encompass all therapeutic, prophylactic, palliative and diagnostic uses for SPY003, subject to certain restrictions. The Option with respect to one additional program remains unexercised under the Paragon Agreement.

Previous wording

Our critical accounting policies are those policies which require the most significant judgments and estimates in the preparation of our consolidated financial statements. The most significant estimates and assumptions that management considers in the preparation of our financial statements relate to accrued research and development costs; the discount rate, probabilities of success, estimated reimbursement rates compared with reimbursement targets, and timing of estimated cash flows in the valuation of the contingent value right (“CVR”) liability and inputs used in the Black-Scholes model for stock-based compensation expense.

Current wording

Our critical accounting policies are those policies which require the most significant judgments and estimates in the preparation of our consolidated financial statements. The most significant estimates and assumptions that management considers in the preparation of our financial statements relate to accrued research and development costs and inputs used in the Black-Scholes model for stock-based compensation expense.

Previous wording

We define our critical accounting policies as those accounting principles generally accepted in the United States that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. There have been no significant changes to our critical accounting policies and estimates as compared to the critical accounting policies and estimates disclosed in “Management’s Discussion and Analysis of Financial Condition and Operations” included in our Annual Report.

Current wording

We define our critical accounting policies as those accounting principles generally accepted in the United States that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. There have been no significant changes to our critical accounting policies and estimates as compared to the critical accounting policies and estimates disclosed in “Management’s Discussion and Analysis of Financial Condition and Operations” included in our Annual Report, except as disclosed below:

Previous wording

Research and Development Expenses. Research and development expenses increased by $18.8 million, or 45%, to $60.4 million for the three months ended March 31, 2026, from $41.6 million for the three months ended March 31, 2025. The increase was primarily driven by higher clinical trial expenses , manufacturing expenses, and increased compensation costs partially offset by lower early-stage research and development costs.

Current wording

Research and Development Expenses. Research and development expenses increased by $25.4 million, or 63%, to $65.5 million for the three months ended June 30, 2026, from $40.1 million for the three months ended June 30, 2025. The increase was primarily driven by higher manufacturing expenses, clinical trial expenses, and compensation costs partially offset by lower early-stage research and development costs.

Previous wording

External research and development expenses include costs associated with third parties contracted to conduct research and development activities on our behalf, including through Paragon, contract research organizations, contract manufacturing organizations, and third-party laboratories. For the three months ended March 31, 2026 and 2025, external research and development costs accounted for $46.3 million and $33.5 million, respectively. Preclinical expenses decreased primarily due to a reduction in early-stage research and development activities given our pipeline's advancement. IBD expenses increased primarily due to an increase in manufacturing costs and clinical development activities related to ongoing or planned clinical trials. Rheumatic diseases costs increased due to increases in manufacturing costs and clinical development costs.

Current wording

External research and development expenses include costs associated with third parties contracted to conduct research and development activities on our behalf, including through Paragon, contract research organizations (“CROs”), contract manufacturing organizations (“CMOs”), and third-party laboratories. For the three months ended June 30, 2026 and 2025, external research and development costs accounted for $49.9 million and $30.4 million, respectively. Preclinical expenses decreased primarily due to a reduction in early-stage research and development activities given our pipeline's advancement. IBD and Rheumatic diseases expenses increased primarily due to an increase in manufacturing costs and clinical development activities related to ongoing or planned clinical trials.

Previous wording

Internal research and development expenses include compensation and related costs associated with our research and development employees. For the three months ended March 31, 2026 and 2025, internal research and development costs accounted for $14.2 million and $8.1 million, respectively. The increase was primarily driven by an increase in compensation costs due to an increase in research and development headcount.

Current wording

Internal research and development expenses include compensation and related costs associated with our research and development employees. For the three months ended June 30, 2026 and 2025, internal research and development costs accounted for $15.6 million and $9.8 million, respectively. The increase was primarily driven by an increase in compensation costs due to an increase in research and development headcount.

Previous wording

General and Administrative Expenses. General and administrative expenses increased by $3.3 million, or 28%, to $15.2 million for the three months ended March 31, 2026, from $11.9 million for the three months ended March 31, 2025. The increase was primarily attributable to an increase in compensation costs due to an increase in general and administrative headcount.

Current wording

General and Administrative Expenses. General and administrative expenses increased by $4.3 million, or 37%, to $16.1 million for the three months ended June 30, 2026, from $11.8 million for the three months ended June 30, 2025. The increase was primarily attributable to an increase in compensation costs due to an increase in general and administrative headcount.

Previous wording

Other (expense) income, net. Other (expense) income, net for the three months ended March 31, 2026 increased by $32.6 million versus the three months ended March 31, 2025 primarily driven by changes in the fair value of the CVR liability, which was primarily driven by changes in the likelihood of achievement of certain milestones, changes in the risk-adjusted discount rates and time value of money adjustments.

Current wording

Other expense, net. Other expense, net for the three months ended June 30, 2026 increased by $4.0 million versus the three months ended June 30, 2025 primarily driven by changes in the fair value of the CVR liability, which was primarily driven by changes in the likelihood of achievement of certain milestones, changes in the risk-adjusted discount rates and time value of money adjustments.

Previous wording

Gain on Sale of In-Process Research and Development Asset. During the three months ended March 31, 2026, the Company recognized a gain of $30.0 million for an achieved milestone related to the 2023 sale of the global rights of the legacy Aeglea asset pegzilarginase to Immedica, driven by regulatory approval of pegzilarginase in the United States. There was no similar gain or loss during the three months ended March 31, 2025.

Current wording

Gain on Sale of In-Process Research and Development Asset. During the six months ended June 30, 2026 and 2025, the Company recognized gains of $70.0 million and $10.0 million, respectively, related to milestone payments earned in connection with the 2023 sale of the global rights to the legacy Aeglea asset pegzilarginase to Immedica. The 2026 gain was triggered by the regulatory approval of pegzilarginase in the United States and the sale of the related PRV, while the 2025 gain was triggered by a favorable reimbursement decision for pegzilarginase in Europe.

Previous wording

Since our inception and through March 31, 2026, we have funded our operations by raising an aggregate of approximately $1.7 billion of gross proceeds from the sale and issuance of convertible preferred stock and common stock, pre-funded warrants, the collection of grant proceeds, and the licensing of our product rights for commercialization of pegzilarginase in Europe and certain countries in the Middle East. As of March 31, 2026, we had an accumulated deficit of $1.2 billion. In April 2026, we raised an additional approximately $435.3 million in net proceeds from a public underwritten offering of our common stock.

Current wording

Since our inception and through June 30, 2026, we have funded our operations by raising an aggregate of approximately $2.1 billion of gross proceeds from the sale and issuance of convertible preferred stock and common stock, pre-funded warrants, the collection of grant proceeds, and the licensing of our product rights for commercialization of pegzilarginase in Europe and certain countries in the Middle East. As of June 30, 2026, we had an accumulated deficit of $1.2 billion. In April 2026, we raised an additional approximately $435.2 million in net proceeds from a public underwritten offering of our common stock.

Previous wording

On September 6, 2024, the Company entered into a sales agreement (the “Sales Agreement”) with TD Securities (USA) LLC as its agent, pursuant to which the Company may issue and sell up to $200.0 million of shares of common stock under an at-the-market (“ATM”) offering program. During the year ended December 31, 2025, we sold an aggregate of 445,668 shares of common stock under the ATM offering program at an average price per share of $33.772 resulting in net proceeds of $14.8 million, after deducting sales agent commissions and other offering costs of $0.3 million. During the three months ended March 31, 2026, the Company sold an aggregate of 296,396 shares of common stock under the ATM offering program at an average price per share of $33.566 resulting in net proceeds of $9.7 million after deducting sales agent commissions and other offering costs of $0.2 million. As of March 31, 2026, $154.1 million remained available for sale under the Sales Agreement.

Current wording

On September 6, 2024, the Company entered into a sales agreement (the “2024 Sales Agreement”) with TD Securities (USA) LLC as its agent, pursuant to which the Company may issue and sell up to $200.0 million of shares of common stock under an at-the-market (“ATM”) offering program. During the year ended December 31, 2025, we sold an aggregate of 445,668 shares of common stock under the ATM offering program pursuant to the 2024 Sales Agreement resulting in net proceeds of $14.8 million. During the six months ended June 30, 2026, the Company sold an aggregate of 296,396 shares of common stock under the ATM offering program pursuant to the 2024 Sales Agreement resulting in net proceeds of $9.7 million. The 2024 Sales Agreement was terminated on June 26, 2026 and the Company concurrently entered into a new sales agreement (the “2026 Sales Agreement”) with TD Securities (USA) LLC as its agent, pursuant to which the Company may issue and sell up to $500.0 million of shares of common stock under an ATM offering program. During the three months ended June 30, 2026, the Company did not sell any shares under the ATM offering program pursuant to the 2026 Sales Agreement. As of June 30, 2026, $500.0 million remained available for sale under the 2026 Sales Agreement.

Previous wording

In April 2026, we sold an aggregate of 7,475,000 shares of our common stock, inclusive of 975,000 shares pursuant to the full exercise of the underwriters' over-allotment option, at a public offering price per share of $62.00, resulting in net proceeds of approximately $435.3 million after deducting approximately $28.1 million of underwriting discounts and other offering costs.

Current wording

In April 2026, we sold an aggregate of 7,475,000 shares of our common stock in an underwritten public offering, inclusive of 975,000 shares pursuant to the full exercise of the underwriters' over-allotment option, at a public offering price per share of $62.00, resulting in net proceeds of approximately $435.2 million after deducting approximately $28.2 million of underwriting discounts and other offering costs.

Previous wording

Cash used in operating activities for the three months ended March 31, 2026 was $57.4 million and primarily reflected a net loss of $69.0 million adjusted for a $30.0 million non-operating gain on sale of in-process research and development and a $30.3 million increase in the fair value of the CVR liability, partially offset by non-cash expenses of $12.8 million for share-based compensation expense, $2.1 million in net accretion of discount on marketable securities.

Current wording

Cash used in operating activities for the six months ended June 30, 2026 was $127.2 million and primarily reflected a net loss of $105.2 million adjusted for a $70.0 million non-operating gain on sale of in-process research and development, a $8.8 million decrease in net operating assets and liabilities driven by timing of payments to vendors, a $4.5 million in net accretion of discount on marketable securities, net of interest proceeds from maturities of zero coupon U.S. Treasury Bills, partially offset by non-cash expenses of $34.9 million due to an increase in the fair value of the CVR liability, and $26.3 million for share-based compensation expense.

Previous wording

Cash used in operating activities for the three months ended March 31, 2025 was $41.0 million and reflected a net loss of $44.8 million coupled with $2.6 million in net accretion of discount on marketable securities and a $2.4 million non-cash gain from the decrease of the CVR liability fair value, partially offset by stock-based compensation of $8.9 million.

Current wording

Cash used in operating activities for the six months ended June 30, 2025 was $87.6 million and primarily reflected a net loss of $81.5 million coupled with net loss adjustments of a $10.0 million gain on sale of in-process research and development and a $9.6 million decrease in net operating assets and liabilities driven by timing of payments to vendors, partially offset by stock-based compensation of $18.2 million.

Previous wording

Cash provided by investing activities for the three months ended March 31, 2026 was $56.6 million and primarily consisted of $107.7 million in maturities and sales of marketable securities and $30.0 million in proceeds from the sale of in-process research & development asset, partially offset by $81.2 million in purchases of marketable securities.

Current wording

Cash provided by investing activities for the six months ended June 30, 2025 was $78.9 million and primarily consisted of $178.2 million in maturities and sales of marketable securities, $7.0 million in proceeds from the sale of an in-process research & development asset, partially offset by $106.3 million in purchases of marketable securities.

Previous wording

Cash provided by financing activities for the three months ended March 31, 2026 was $12.3 million, which primarily consisted of $9.8 million net proceeds from the issuance of common stock in connection with the ATM offering program and $2.7 million proceeds from stock option exercises and sales of common stock under our Employee Stock Purchase Plan, partially offset by $0.2 million payment of deferred offering costs.

Current wording

Cash provided by financing activities for the six months ended June 30, 2026 was $444.9 million, which primarily consisted of $435.2 million and $9.8 million net proceeds from the issuance of common stock in connection with the April 2026 follow-on offering and ATM offering program, respectively, and $23.3 million proceeds from stock option exercises and sales of common stock under our ESPP, partially offset by a $22.9 million payment to CVR holders.

Previous wording

Through the Asset Acquisition, we received the Option to license certain intellectual property rights related to certain research programs. The exercise of the Option allows for us to enter into an exclusive license agreement with Paragon for the respective research program. Thus far we have exercised the Option and entered into license agreements with respect to SPY001, SPY002, SPY072 and SPY003. Under the terms of each License Agreement, we are obligated to pay Paragon up to $22.0 million based on specific development, regulatory and clinical milestones for the first product under each agreement. As of March 31, 2026, we have incurred a total of $21 million of milestone fees out of a total maximum of $66.0 million in potential milestone fees across all License Agreements. As of March 31, 2026 no achieved milestone fees are outstanding and payable. With respect to the SPY002 and SPY072 License Agreement only, on a product by product basis, we are obligated to pay sublicensing fees of up to approximately $20 million upon the achievement of mostly commercial milestones. As of March 31, 2026, we have incurred $2.6 million of sublicensing fees of which none is outstanding and payable.

Current wording

Through the Asset Acquisition, we received the Option to license certain intellectual property rights related to certain research programs. The exercise of the Option allows for us to enter into an exclusive license agreement with Paragon for the respective research program. Thus far we have exercised the Option and entered into license agreements with respect to SPY001, SPY002, SPY072 and SPY003. Under the terms of each License Agreement, we are obligated to pay Paragon up to $22.0 million based on specific development, regulatory and clinical milestones for the first product under each agreement. As of June 30, 2026, we have incurred a total of $21.0 million of milestone fees out of a total maximum of $66.0 million in potential milestone fees across all License Agreements. As of June 30, 2026, no achieved milestone fees are outstanding and payable. With respect to the SPY002 and SPY072 License Agreement only, on a product-by-product basis, we are obligated to pay sublicensing fees of up to approximately $20.0 million upon the achievement of mostly commercial milestones. As of June 30, 2026, we have incurred $2.6 million of sublicensing fees of which none is outstanding and payable.
Rearranged current paragraphs (7)

Current report — wording carried from elsewhere

2025, we presented additional preclinical data, demonstrating that combinations resulted in superior in vivo biological activity relative to either monotherapy in mouse TNBS model. In addition, combination toxicology studies have been completed with no drug-related adverse findings observed.

Current report — wording carried from elsewhere

The following table summarizes our results of operations for the six months ended June 30, 2026 and 2025, together with the changes in those items in dollars and as a percentage:

Current report — wording carried from elsewhere

External research and development expenses include costs associated with third parties contracted to conduct research and development activities on our behalf, including through Paragon, CROs, CMOs, and third- party laboratories. For the six months ended June 30, 2026 and 2025, external research and development costs accounted for $96.1 million and $63.9 million, respectively. Preclinical expenses decreased primarily due to a reduction in early-stage research and development activities given our pipeline's advancement. IBD and Rheumatic diseases expenses increased primarily due to an increase in manufacturing costs and clinical development activities related to ongoing or planned clinical trials.

Current report — wording carried from elsewhere

Internal research and development expenses include compensation and related costs associated with our research and development employees. For the six months ended June 30, 2026 and 2025, internal research and development costs accounted for $29.8 million and $17.9 million, respectively. The increase was primarily driven by an increase in research and development headcount.

Current report — wording carried from elsewhere

Other (expense) income, net. Other (expense) income, net for the six months ended June 30, 2026 increased by $36.6 million versus the six months ended June 30, 2025 primarily driven by changes in the fair value of the CVR liability, which was primarily driven by changes in the likelihood of achievement of certain milestones and receipt of certain cash consideration within the CVR term, changes in estimated reimbursement rates compared to reimbursement target rates, changes in estimated cash flow dates, and an increase in risk-adjusted discount rates, partially offset by time value of money adjustments.

Current report — wording carried from elsewhere

Cash (Used in) Provided By Investing Activities

Current report — wording carried from elsewhere

Cash used in investing activities for the six months ended June 30, 2026 was $241.3 million and primarily consisted of $528.5 million in purchases of marketable securities, partially offset by $217.2 million in maturities and sales of marketable securities and $70.0 million in proceeds from the sale of an in-process research & development asset.
Rearranged previous paragraphs (2)

Previous report — wording carried elsewhere

Cash Provided By (Used in) Investing Activities

Previous report — wording carried elsewhere

Cash used in investing activities for the three months ended March 31, 2025 was $0.1 million.