Oruka expands IL-23 license, adds dosing limits

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Form Type

8-K

Rhea-AI Filing Summary

Oruka Therapeutics, Inc. entered into a First Amendment to its IL-23 License Agreement with Paragon Therapeutics, Inc. This amendment broadens Oruka’s licensed field to cover all therapeutic, prophylactic, palliative and diagnostic uses of the IL‑23 program, including inflammatory bowel disease, subject to timing limits on when dosing may begin.

Under the amendment, Oruka may not dose a human patient in a clinical trial of ORKA‑001 for inflammatory bowel disease in a combination regimen until June 1, 2028, or as a monotherapy until June 1, 2030. If Oruka or a Paragon licensee completes a material transaction such as a change of control, any remaining restrictions outside the original field will continue only until June 1, 2028 and then terminate.

Insights

Oruka widened its IL‑23 license scope but accepted time-based dosing limits.

Oruka Therapeutics expanded the licensed “Field” under its IL‑23 License Agreement with Paragon to include all therapeutic, prophylactic, palliative and diagnostic uses, now explicitly covering inflammatory bowel disease. This increases the range of potential future indications linked to ORKA‑001.

The amendment adds clear timing restrictions: no ORKA‑001 inflammatory bowel disease dosing in combination trials before June 1, 2028, or as monotherapy before June 1, 2030. It also introduces an adjustment if a material transaction such as a change of control occurs, after which remaining out‑of‑field limits fall away after June 1, 2028. Subsequent company disclosures may clarify development plans within these windows.

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

Combination dosing earliest date: June 1, 2028 Monotherapy dosing earliest date: June 1, 2030 Amendment date: May 29, 2026

3 metrics

Combination dosing earliest date June 1, 2028 Earliest ORKA-001 IBD combination trial dosing

Monotherapy dosing earliest date June 1, 2030 Earliest ORKA-001 IBD monotherapy trial dosing

Amendment date May 29, 2026 Date First Amendment to IL-23 License Agreement executed

Key Terms

IL-23 License Agreement, Monotherapy Dosing Restriction, change of control, inflammatory bowel disease

4 terms

IL-23 License Agreement financial

"First Amendment to IL-23 License Agreement, dated May 29, 2026"

Monotherapy Dosing Restriction regulatory

"set forth in the Monotherapy Dosing Restriction shall remain in effect"

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.

inflammatory bowel disease medical

"did not include inflammatory bowel disease. The Amendment, among other things, expands"

Inflammatory bowel disease is a group of long‑lasting conditions that cause repeated inflammation of the digestive tract, leading to symptoms like belly pain, diarrhea, bleeding and weight loss. For investors it matters because IBD drives steady demand for medications, ongoing clinical trials, medical devices and diagnostics; think of it as a chronic maintenance market where successful treatments can create predictable, long‑term revenue streams and regulatory milestones can move stock prices.

FAQ

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What did Oruka Therapeutics (ORKA) announce in this 8-K filing?

Oruka Therapeutics entered a First Amendment to its IL‑23 License Agreement with Paragon Therapeutics. The amendment broadens the licensed field and sets specific dates when ORKA‑001 can begin inflammatory bowel disease clinical dosing.

How does the IL-23 license amendment affect Oruka Therapeutics’ rights?

The amendment expands the definition of the licensed Field to all therapeutic, prophylactic, palliative and diagnostic uses. This now includes inflammatory bowel disease, subject to specified start dates for clinical dosing of ORKA‑001 in combination and monotherapy settings.

When can Oruka start ORKA-001 inflammatory bowel disease combination trials?

Under the amendment, Oruka will not dose a human patient with ORKA‑001 for inflammatory bowel disease in a combination clinical trial until June 1, 2028. This date defines the earliest start of such combination dosing activity for that indication.

When can Oruka run ORKA-001 monotherapy trials in inflammatory bowel disease?

The amendment restricts monotherapy use of ORKA‑001 in inflammatory bowel disease clinical trials until June 1, 2030. Before that date, Oruka is not permitted to dose human patients with ORKA‑001 as a standalone treatment for this indication.

What happens to the dosing restrictions if there is a change of control?

If Oruka or a Paragon licensee completes a material transaction, including a change of control, any remaining restrictions outside the initial Field definition continue only until June 1, 2028. After that date, those remaining limits terminate and no longer apply.

Where can investors read the full IL-23 license amendment for Oruka Therapeutics?

The complete text of the First Amendment to the IL‑23 License Agreement is filed as Exhibit 10.1. The 8‑K notes that its brief description is qualified in its entirety by reference to this full exhibit document.

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Accepted by SEC EDGAR 06/01/2026 - 04:01 PM EDT

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

Oruka Therapeutics, Inc.

(Exact name of Registrant as Specified in its Charter)

Delaware		000-22873		36-3855489
(State or other jurisdiction of incorporation)		(Commission File Number)		(IRS Employer Identification No.)

855 Oak Grove Avenue

Suite 100

Menlo Park, California

94025

(Address of principal executive offices)

(Zip Code)

Registrant’s telephone number, including area code: (650) 606-7910

N/A

(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:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐	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, $0.001 par value		ORKA		The Nasdaq Global 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 ☐

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. ☐

Item 8.01. Other Events.

On May 29, 2026, Oruka Therapeutics, Inc. (the “Company”) entered into the First Amendment to IL-23 License Agreement (the “Amendment”), amending the IL-23 License Agreement dated as of December 17, 2024 (the “License Agreement”), by and between the Company and Paragon Therapeutics, Inc. (“Paragon”). Prior to the Amendment, the Company’s Field did not include 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 ORKA-001 for 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 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 do 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 No.		Description
10.1		First Amendment to IL-23 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.

	Oruka Therapeutics, Inc.
	(Registrant)

Date: June 1, 2026	By:	/s/ Paul Quinlan
		Name:	Paul Quinlan
		Title:	General Counsel

Source: View Original Filing on SEC EDGAR

Filing Exhibits & Attachments

4 documents

Agreements & Contracts

EX-10.1 FIRST AMENDMENT TO IL-23 LICENSE AGREEMENT, DATED MAY 29, 2026 25.5 KB

Oruka expands IL-23 license, adds dosing limits

Rhea-AI Filing Summary