Spyre expands SPY003 license but adds dosing limits

Spyre Therapeutics reported an amendment to its SPY003 license agreement with Paragon Therapeutics.

Rhea-AI Filing Summary

Spyre Therapeutics reported an amendment to its SPY003 license agreement with Paragon Therapeutics. The change expands Spyre’s rights from only inflammatory bowel disease to all therapeutic, prophylactic, palliative and diagnostic uses for SPY003.

This broader license is subject to dosing limits. Spyre will not dose human patients with SPY003 outside inflammatory bowel disease in a clinical trial as part of a combination before June 1, 2028, or as a monotherapy before June 1, 2030, under what is termed the Monotherapy Dosing Restriction.

If Spyre or a Paragon licensee completes a material transaction, such as a change of control, any remaining restrictions outside the original inflammatory bowel disease field will end on June 1, 2028. The full terms are set out in the filed amendment.

Insights

Biotech licensing and strategy analyst

Spyre broadens SPY003 rights but faces staged dosing limits.

The amendment gives Spyre Therapeutics access to all therapeutic and diagnostic uses for SPY003, whereas it was previously confined to inflammatory bowel disease. This widens long-term optionality around indications while keeping existing IBD development paths unchanged.

The Monotherapy Dosing Restriction delays SPY003 dosing in non-IBD indications until June 1, 2028 for combinations and June 1, 2030 for monotherapy. These timing constraints shape when broader clinical programs can begin, without altering current IBD work.

A key clause shortens remaining restrictions if a material transaction, including a change of control, occurs so that limits expire on June 1, 2028. Subsequent company disclosures may clarify how this flexibility influences partnering or M&A discussions related to SPY003.

8-K Event Classification

2 items: 8.01, 9.01

2 items

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

Key Figures

Amendment date: May 29, 2026 Combination dosing outside IBD: June 1, 2028 Monotherapy dosing outside IBD: June 1, 2030 +1 more

4 metrics

Amendment date May 29, 2026 Date Spyre entered First Amendment to SPY003 License Agreement

Combination dosing outside IBD June 1, 2028 Earliest date to dose SPY003 outside IBD in combination trials

Monotherapy dosing outside IBD June 1, 2030 Earliest date to dose SPY003 outside IBD as monotherapy

Restriction end on material transaction June 1, 2028 Date after which remaining expanded-field limits terminate if a material transaction occurs

Key Terms

Monotherapy Dosing Restriction, material transaction, change of control, Emerging growth company, +1 more

5 terms

Monotherapy Dosing Restriction regulatory

"set forth in the Monotherapy Dosing Restriction"

material transaction financial

"consummates a material transaction, including a change of control"

change of control financial

"including a change of control of the Company or such licensee"

A change of control occurs when the ownership or management of a company shifts significantly, such as through a sale, merger, or acquisition, resulting in new leadership or ownership structure. This change can impact the company's direction and decision-making, which is important for investors because it may affect the company's stability, strategy, and future prospects.

Emerging growth company regulatory

"Emerging growth company o"

An emerging growth company is a recently public or smaller public firm that qualifies for temporary, lighter regulatory and disclosure rules to reduce the cost and effort of being public. For investors, it means the company may provide less historical financial detail and face fewer reporting requirements than larger firms, so it can grow more quickly but also carries higher uncertainty—like buying a promising early-stage product with fewer user reviews.

Amended and Restated License Agreement regulatory

"First Amendment to Amended and Restated License Agreement"

FAQ

What did Spyre Therapeutics (SYRE) change in the SPY003 license?

Spyre expanded the SPY003 license with Paragon from only inflammatory bowel disease to all therapeutic, prophylactic, palliative and diagnostic uses. This broader field increases potential future applications while maintaining specific timing limits on non-IBD clinical dosing.

What is the Monotherapy Dosing Restriction for Spyre Therapeutics’ SPY003?

The Monotherapy Dosing Restriction bars Spyre from dosing human patients with SPY003 outside inflammatory bowel disease in clinical trials as a combination before June 1, 2028, or as a monotherapy before June 1, 2030, defining when broader indication trials can start.

How does a material transaction affect SPY003 restrictions for Spyre Therapeutics (SYRE)?

If Spyre or a Paragon licensee completes a material transaction, including a change of control, any remaining SPY003 restrictions outside the original inflammatory bowel disease field will apply only until June 1, 2028, after which they terminate, potentially accelerating broader development flexibility.

Who is Spyre Therapeutics’ counterparty in the SPY003 license amendment?

Spyre Therapeutics’ counterparty is Paragon Therapeutics, Inc. The companies amended their Amended and Restated License Agreement for SPY003, originally dated February 24, 2025, to expand the licensed field and define new dosing timing restrictions and change-of-control-related provisions.

Where can investors find the full SPY003 license amendment for Spyre Therapeutics?

The complete First Amendment to the Amended and Restated IL‑23 (SPY003) License Agreement, dated May 29, 2026, is filed as Exhibit 10.1. The 8‑K notes that its summary is qualified entirely by reference to this full agreement text.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 06/01/2026 - 04:01 PM Learn about SEC filing dates

false000163628200016362822026-05-292026-05-29

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

_______________________________________________________

FORM 8-K

_______________________________________________________

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 29, 2026

_______________________________________________________

SPYRE THERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)

_______________________________________________________

Delaware			001-37722			46-4312787
(State or Other Jurisdiction of Incorporation)			(Commission File Number)			(IRS Employer Identification No.)
221 Crescent Street Building 23 Suite 105
Waltham, MA						02453
(Address of Principal Executive Offices)						(Zip Code)

Registrant’s Telephone Number, Including Area Code: 617 651-5940

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

_______________________________________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o			Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.0001 Par Value Per Share

SYRE

The Nasdaq Stock Market LLC (Nasdaq Global Select Market)

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company o

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o

Item 8.01 Other Events.

On May 29, 2026, the Company entered into the First Amendment to Amended and Restated License Agreement (the "Amendment"), amending the Amended and Restated License Agreement dated as of February 24, 2025 (as amended, the "SPY003 License Agreement"), by and between the Company and Paragon Therapeutics, Inc. ("Paragon"). Prior to the Amendment, the Company's Field was limited to inflammatory bowel disease. The Amendment, among other things, expands the definition of "Field" to encompass all therapeutic, prophylactic, palliative and diagnostic uses, subject to the restriction that the Company will not dose a human patient in a clinical trial of SPY003 for an indication outside of inflammatory bowel disease as part of a combination until June 1, 2028 or as a monotherapy until June 1, 2030 (the "Monotherapy Dosing Restriction"). In the event the Company or a licensee of Paragon's retained rights under the SPY003 License Agreement consummates a material transaction, including a change of control of the Company or such licensee, then any remaining restrictions outside of the initial definition of "Field" set forth in the Monotherapy Dosing Restriction shall remain in effect only until June 1, 2028 and thereafter terminate and be of no further force or effect.

The foregoing is a brief description of the terms and conditions of the Amendment and does not purport to be complete. The description is qualified in its entirety by reference to the complete text of the Amendment, a copy of which is attached hereto as Exhibit 10.1.

Item 9.01 Financial Statements and Exhibits.

(d)Exhibits

Exhibit Number						Description
10.1						First Amendment to Amended and Restated IL-23 (SPY003) License Agreement, dated May 29, 2026.
104						Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

									SPYRE THERAPEUTICS, INC.
Date:			June 1, 2026			By:			/s/ Cameron Turtle
									Cameron Turtle Chief Executive Officer

Filing Exhibits & Attachments

4 documents

Agreements & Contracts

• EX-10.1 EX-10.1 30.6 KB

Other Documents

• EX-101 XBRL TAXONOMY EXTENSION SCHEMA DOCUMENT 1.7 KB
• EX-101 XBRL TAXONOMY EXTENSION LABEL LINKBASE DOCUMENT 23.2 KB
• EX-101 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE DOCUMENT 13.5 KB