Spyre Therapeutics, Inc.

Previous wording

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

Previous wording

SKYLINE-UC Phase 2 Platform Trial in UC

Current wording

SKYLINE Phase 2 Platform Trial in UC

Previous wording

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

Current wording

In May 2025, we initiated our SKYLINE Phase 2 platform trial evaluating SPY001, SPY002, SPY003, as well as pairwise combinations thereof (six active investigational agents in total), in patients with moderately to severely active UC. 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.

Current wording

•Part A: Open-label assessment of the safety and preliminary efficacy of a single dose level of each investigational monotherapy, with induction data expected in 2026.

Previous wording

•Part B: Randomized and placebo-controlled assessment of the safety and efficacy of monotherapies and combinations, designed to provide dose-ranging data on monotherapies, proof-of-concept and contribution of components for combinations.

Current wording

•Part B: Randomized and placebo-controlled assessment of the safety and efficacy of monotherapies and combinations, designed to provide dose-ranging data on monotherapies, proof-of-concept and contribution of components for combinations, with induction data expected in 2027.

Previous wording

SKYLINE-UC is currently enrolling subjects into the SPY001 arm of Part A.

Current wording

SKYLINE is currently enrolling subjects into the SPY001 and SPY002 arms of Part A, with SPY003 expected to begin enrolling in the coming months. Part B is expected to begin enrolling after Part A completes enrollment.

Previous wording

SKYWAY-RD Phase 2 Basket Trial in Rheumatic Diseases (RA, PsA, axSpA)

Current wording

SKYWAY Phase 2 Basket Trial in Rheumatic Diseases (RA, PsA, axSpA)

Previous wording

SKYWAY-RD is a planned Phase 2 randomized and placebo-controlled basket trial of SPY072 in patients with moderately to severely active RA, PsA, or axSpA. Trial initiation is expected in the third quarter of 2025 and 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 patients with moderately to severely active RA, PsA, or axSpA. The trial consists of three sub-studies:

Previous wording

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 is a double blind, placebo-controlled trial in healthy volunteers and consists of a single-ascending dose ("SAD") component and a multi-ascending dose ("MAD") component. The trial design includes enrolling 56 healthy adult participants into five SAD cohorts and two MAD cohorts in the main portion of the study. The primary endpoint is safety, with PK and anti-drug antibodies ("ADA") serving as secondary endpoints. Additional cohorts have been added to the study to evaluate PK in healthy volunteers of various ethnicities to facilitate subsequent global clinical trials. Trial enrollment is now complete.

Current wording

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 is a double blind, placebo-controlled trial in healthy volunteers and consists of a single-ascending dose ("SAD") component and a multi-ascending dose ("MAD") component. The trial design includes enrolling 56 healthy adult participants into five SAD cohorts and two MAD cohorts in the main portion of the study. The primary endpoint is safety, with PK and anti-drug antibodies ("ADA") serving as secondary endpoints. Additional cohorts have been added to the study to evaluate PK in healthy volunteers of various ethnicities to facilitate subsequent global clinical trials. Phase 1 trial enrollment is now complete.

Previous wording

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 and complete saturation of α4β7 receptors beyond six months with a single dose of 600mg. Based on these results, SPY001 was advanced into the SKYLINE-UC Phase 2 platform clinical trial, which initiated in May 2025.

Current wording

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 and 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, which initiated in May 2025.

Previous wording

SPY002 and SPY072 bind TL1A monomers and trimers and have 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 study. The primary endpoint is safety, with PK and ADAs serving as secondary endpoints, and PD markers as exploratory endpoints. Additional cohorts may be added to the SPY002 and SPY072 Phase 1 studies, for example to evaluate PK in healthy volunteers of various ethnicities, to facilitate subsequent global clinical trials.

Current wording

SPY002 and SPY072 bind 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 study. The primary endpoint is safety, with PK and ADAs serving as secondary endpoints, and PD markers as exploratory endpoints. Phase 1 trial enrollment is now complete.

Previous wording

Phase 1 data were presented in June 2025, with up to 20-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 weeks at single 100mg doses. Based on these interim results, in the third quarter of 2025, SPY002 is expected to advance to the SKYLINE-UC Phase 2 platform trial and SPY072 is expected to advance to the SKYWAY-RD Phase 2 basket trial.

Current wording

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 interim results, SPY002 has advanced to the SKYLINE Phase 2 platform trial and SPY072 has advanced to the SKYWAY Phase 2 basket trial.

Previous wording

SPY120 combines SPY001 (anti-α4β7) and SPY002 (anti-TL1A) antibodies, pairing two mechanisms studied in third-party clinical trials targeting non-overlapping sites of action. We are currently evaluating SPY120 in nonclinical studies, and have initiated combination toxicology studies. Subject to regulatory feedback, we intend to include SPY120 in the SKYLINE-UC Phase 2 platform trial.

Current wording

SPY120 combines SPY001 (anti-α4β7) and SPY002 (anti-TL1A) antibodies, pairing two mechanisms studied in third-party clinical trials targeting non-overlapping sites of action.

Previous wording

In February and May 2025, we presented new preclinical data demonstrating that combinations resulted in additive or greater than additive in vivo biological activity relative to either monotherapy in mouse hapten reagent 2,4,6-trinitrobenzene sulfonic acid ("TNBS") and anti-CD40 colitis models. In addition, coadministration of SPY001 and SPY002 in NHPs demonstrated no drug effects on PK.

Current wording

In February and May 2025, we presented preclinical data demonstrating that combinations resulted in additive or greater than additive in vivo biological activity relative to either monotherapy in mouse hapten reagent 2,4,6-trinitrobenzene sulfonic acid ("TNBS") and anti-CD40 colitis models. In October 2025, we presented preclinical data further demonstrating that combined inhibition resulted in superior efficacy relative to constituent monotherapies in a mouse TNBS-induced colitis model. In addition, combination toxicology studies have been completed with no drug-related adverse findings observed.

Previous wording

SPY130 combines SPY001 (anti-α4β7) and SPY003 (anti-IL-23) antibodies, pairing two commercially validated mechanisms targeting non-overlapping sites of action. We are currently evaluating SPY130 in nonclinical studies and initiated combination toxicology studies in 2024. Subject to regulatory feedback, we intend to include SPY130 in the SKYLINE-UC Phase 2 platform trial.

Current wording

SPY130 combines SPY001 (anti-α4β7) and SPY003 (anti-IL-23) antibodies, pairing two commercially validated mechanisms targeting non-overlapping sites of action.

Previous wording

In October 2024, we presented new preclinical data, demonstrating in a T-cell transfer model of IBD, that combinations with anti-IL-23 and anti-α4ß7 improved body weight and reduced colonic CD4+ infiltration and IL-17 levels relative to monotherapy. In March 2025, we presented additional preclinical data, demonstrating that combinations resulted in additive or greater than additive in vivo biological activity relative to either monotherapy in mouse TNBS model.

Current wording

In October 2024, we presented preclinical data, demonstrating in a T-cell transfer model of IBD, that combinations with anti-IL-23 and anti-α4ß7 improved body weight and reduced colonic CD4+ infiltration and IL-17 levels relative to monotherapy. 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.

Previous wording

SPY230 combines SPY002 (anti-TL1A) and SPY003 (anti-IL-23) antibodies, pairing two complementary mechanisms of action with potential to address overlapping and non-overlapping triggers of inflammation. We are currently evaluating SPY230 in nonclinical studies and initiated combination toxicology studies in 2024. Subject to regulatory feedback, we intend to include SPY230 in the SKYLINE-UC Phase 2 platform trial.

Current wording

SPY230 combines SPY002 (anti-TL1A) and SPY003 (anti-IL-23) antibodies, pairing two complementary mechanisms of action with potential to address overlapping and non-overlapping triggers of inflammation.

Previous wording

In October 2024, we presented new 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 2025, we presented additional preclinical data, demonstrating that combinations resulted in additive in vivo biological activity relative to either monotherapy in mouse TNBS model.

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 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.

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, 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; 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.

Previous wording

Research and Development Expenses. Research and development expenses increased by $7.5 million, or 23%, to $40.1 million for the three months ended June 30, 2025, from $32.6 million for the three months ended June 30, 2024. The increase was primarily driven by higher clinical trial expenses and increased compensation costs, partially offset by lower early-stage R&D costs coupled with decreased intellectual property license and sub-licensing fees.

Current wording

Research and Development Expenses. Research and development expenses increased by $0.5 million, or 1%, to $45.2 million for the three months ended September 30, 2025, from $44.7 million for the three months ended September 30, 2024. The increase was primarily driven by higher clinical trial expenses, intellectual property license and sub-licensing fees, manufacturing expenses, and increased 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 ("CROs"), contract manufacturing organizations ("CMOs"), and third-party laboratories. For the three months ended June 30, 2025 and 2024, external research and development costs accounted for $30.4 million and $27.7 million, respectively. Preclinical expenses decreased primarily due to a reduction in early-stage R&D activities given our pipeline's advancement coupled with lower intellectual property license and sub-licensing fees. IBD expenses increased primarily due to an increase in clinical development activities related to ongoing or planned clinical trials partially offset by lower license and sub-licensing fees as well as lower manufacturing costs. Rheumatic diseases costs increased due to increases in manufacturing and clinical development costs. External stock-based compensation decreased due to our obligations ending under the Parapyre Option Obligation.

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, contract manufacturing organizations, and third-party laboratories. For the three months ended September 30, 2025 and 2024, external research and development costs accounted for $34.3 million and $38.9 million, respectively. Preclinical expenses decreased primarily due to a reduction in early-stage research and development activities given our pipeline's advancement coupled with lower intellectual property license and sub-licensing fees. IBD expenses increased primarily due to an increase in clinical development activities related to ongoing or planned clinical trials and intellectual property licensing and sub-licensing fees partially offset by lower manufacturing costs. Rheumatic diseases costs increased due to increases in manufacturing costs, clinical development costs, and intellectual property licensing and sub-licensing fees. External stock-based compensation decreased due to our obligations ending under the Parapyre Option Obligation.

Previous wording

Internal research and development expenses include compensation and related costs associated with our research and development employees. For the six months ended June 30, 2025 and 2024, internal research and development costs accounted for $17.9 million and $8.5 million, respectively. The increase was primarily driven by 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 September 30, 2025 and 2024, internal research and development costs accounted for $10.9 million and $5.8 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 $0.3 million, or 2%, to $11.8 million for the three months ended June 30, 2025, from $11.5 million for the three months ended June 30, 2024. The increase was primarily attributable to an increase in compensation.

Current wording

General and Administrative Expenses. General and administrative expenses increased by $1.0 million, or 9%, to $11.6 million for the three months ended September 30, 2025, from $10.6 million for the three months ended September 30, 2024. The increase was primarily attributable to an increase in compensation costs due to an increase in general and administrative headcount.

Previous wording

The following table summarizes our results of operations for the six months ended June 30, 2025 and 2024, together with the changes in those items in dollars and as a percentage:

Current wording

The following table summarizes our results of operations for the nine months ended September 30, 2025 and 2024, together with the changes in those items in dollars and as a percentage:

Previous wording

Research and Development Expenses. Research and development expenses increased by $14.2 million, or 21%, to $81.8 million for the six months ended June 30, 2025, from $67.6 million for the six months ended June 30, 2024. The increase was primarily driven by higher clinical development activities and increased compensation costs, partially offset by lower early-stage R&D costs coupled with decreased intellectual property license and sub-licensing fees.

Current wording

Research and Development Expenses. Research and development expenses increased by $14.7 million, or 13%, to $127.0 million for the nine months ended September 30, 2025, from $112.3 million for the nine months ended September 30, 2024. The increase was primarily driven by higher clinical development activities, increased compensation costs and higher intellectual property license and sub-licensing fees, partially offset by lower early-stage research and development.

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 six months ended June 30, 2025 and 2024, external research and development costs accounted for $63.9 million and $59.1 million, respectively. Preclinical expenses decreased primarily due to a reduction in early-stage R&D activities given our pipeline's advancement coupled with lower intellectual property license and sub-licensing fees. IBD expenses increased primarily due to an increase in clinical development costs related to ongoing or planned clinical trials partially offset by decreased manufacturing costs. Rheumatic diseases costs increased due to increases in manufacturing and clinical development costs. External stock-based compensation decreased due to our obligations ending under the Parapyre Option Obligation.

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, contract manufacturing organizations, and third-party laboratories. For the nine months ended September 30, 2025 and 2024, external research and development costs accounted for $98.2 million and $98.0 million, respectively. Preclinical expenses decreased primarily due to a reduction in early-stage research and development activities given our pipeline's advancement coupled with lower intellectual property license and sub-licensing fees. IBD expenses increased primarily due to increases in clinical development costs related to ongoing or planned clinical trials and intellectual property licensing and sub-licensing fees partially offset by decreased manufacturing costs. Rheumatic diseases costs increased due to increases in manufacturing, clinical development costs, and intellectual property licensing and sub-licensing fees. External stock-based compensation decreased due to our obligations ending under the Parapyre Option Obligation.

Previous 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, 2025 and 2024, internal research and development costs accounted for $9.8 million and $4.9 million, respectively. The increase was primarily driven by 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 nine months ended September 30, 2025 and 2024, internal research and development costs accounted for $28.8 million and $14.3 million, respectively. The increase was primarily driven by an increase in research and development headcount.

Previous wording

Gain on Sale of In-Process Research and Development Asset. During the three months ended June 30, 2025, the Company recognized a gain of $10.0 million for achieved milestones related to the 2023 sale of the global rights of the legacy Aeglea asset pegzilarginase to Immedica, driven by a favorable reimbursement decision for pegzilarginase in Europe. There was no similar gain or loss during the three months ended June 30, 2024.

Current wording

Gain on Sale of In-Process Research and Development Asset. During the nine months ended September 30, 2025, the Company recognized a gain of $10.0 million for an achieved milestone related to the 2023 sale of the global rights of the legacy Aeglea asset pegzilarginase to Immedica, driven by a favorable reimbursement decision for pegzilarginase in Europe. There was no similar gain or loss during the nine months ended September 30, 2024.

Previous wording

Interest Income. Interest income was $12.4 million and $10.4 million for the six months ended June 30, 2025 and 2024, respectively. The increase was primarily due to higher investment balances.

Current wording

Interest Income. Interest income was $17.7 million and $15.5 million for the nine months ended September 30, 2025 and 2024, respectively. The increase was primarily due to higher investment balances.

Previous wording

Other income, net. Other income, net for the six months ended June 30, 2025 increased by $2.7 million versus the six months ended June 30, 2024 primarily driven by changes in the fair value of the CVR liability.

Current wording

Other income, net. Other income, net for the nine months ended September 30, 2025 increased by $61.9 million versus the nine months ended September 30, 2024 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..

Previous wording

Since our inception and through June 30, 2025, we have funded our operations by raising an aggregate of approximately $1.3 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, 2025, we had an accumulated deficit of $1.1 billion.

Current wording

Since our inception and through September 30, 2025, we have funded our operations by raising an aggregate of approximately $1.3 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 September 30, 2025, we had an accumulated deficit of $1.1 billion. In October 2025, we raised an additional approximately $296.5 million in net proceeds from a public underwritten offering of our common stock.

Previous 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.

Current wording

Cash used in operating activities for the nine months ended September 30, 2025 was $124.7 million and primarily reflected a net loss of $92.7 million adjusted for a $10.0 million non-operating gain on sale of in-process research and development and a $42.2 million decrease in the fair value of the CVR liability, partially offset by non-cash expenses of $27.8 million for share-based compensation expense and a $3.7 million change in net operating assets and liabilities driven primarily by timing of payments to vendors.

Previous wording

Cash used in operating activities for the six months ended June 30, 2024 was $90.8 million and reflected a net loss of $82.7 million, coupled with net loss adjustments of a $25.7 million decrease in net operating assets and liabilities driven by timing of payments to vendors and $6.0 million in net accretion of discount on marketable securities, partially offset by stock-based compensation of $22.5 million.

Current wording

Cash used in operating activities for the nine months ended September 30, 2024 was $120.2 million and reflected a net loss of $151.7 million. Our net loss was offset in part by non-cash expenses of $35.6 million for share-based compensation expense and a $19.6 million increase in the fair value of the CVR liability, offset by a $15.3 million net change in operating assets and liabilities and $9.0 million in net accretion of discount on marketable securities. The net change in operating assets and liabilities was primarily driven by timing of payments to vendors.

Previous wording

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

Current wording

Cash provided by investing activities for the nine months ended September 30, 2025 was $103.9 million and primarily consisted of $277.4 million in maturities and sales of marketable securities, $7.0 million in proceeds from the sale of in-process research & development asset partially offset by $180.5 million in purchases of marketable securities.

Previous wording

Cash used in investing activities for the six months ended June 30, 2024, was $225.5 million and primarily consisted of $331.1 million in purchases of marketable securities, partially offset by $105.6 million in maturities and sales of marketable securities.

Current wording

Cash used in investing activities for the nine months ended September 30, 2024, was $182.7 million and primarily consisted of $366.2 million in purchases of marketable securities, partially offset by $183.4 million in maturities and sales of marketable securities.

Previous wording

Cash provided by financing activities for the six months ended June 30, 2025 was $0.9 million, which primarily consisted of proceeds from stock option exercises and sales of common stock under our Employee Stock Purchase Plan.

Current wording

Cash used in financing activities for the nine months ended September 30, 2025 was $3.8 million, which primarily consisted of a $5.3 million payment to CVR holders partially offset by $1.6 million proceeds from stock option exercises and sales of common stock under our Employee Stock Purchase Plan.

Previous wording

Cash provided by financing activities for the six months ended June 30, 2024, was $172.5 million, which primarily consisted of the net proceeds from the issuance of the Series B Preferred Stock in the March 2024 PIPE of $169.1 million and $4.9 million from proceeds from stock option exercises and sales of common stock under our Employee Stock Purchase Plan.

Current wording

Cash provided by financing activities for the nine months ended September 30, 2024, was $185.3 million, which primarily consisted of the net proceeds from the issuance of the Series B Preferred Stock in the March 2024 PIPE of $168.9 million, $11.8 million in net proceeds from the issuance of common stock in connection with the ATM, and $6.2 million from proceeds from stock option exercises and sales of Common Stock under our 2016 Employee Stock Purchase Plan and the exercise of pre-funded warrants.

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 June 30, 2025, we have incurred a total of $12.0 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, 2025 no milestone fees remain 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 June 30, 2025 we have incurred $0.7 million of sublicensing fees of which nil remain 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 September 30, 2025, we have incurred a total of $18.0 million of milestone fees out of a total maximum of $66.0 million in potential milestone fees across all License Agreements. As of September 30, 2025, $3.0 million in milestone fees remain 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 September 30, 2025, we have incurred $1.7 million of sublicensing fees of which $1.0 million is outstanding and payable.