Ivonescimab Phase III HARMONi data outlined by Summit (SMMT)

Filing Impact

(Moderate)

Filing Sentiment

(Neutral)

Form Type

8-K

Rhea-AI Filing Summary

Summit Therapeutics Inc. filed a current report to note that it issued a press release on September 7, 2025 announcing ivonescimab data from its global Phase III HARMONi clinical trial. The data were presented the same day during the Presidential Symposium at the International Association for the Study of Lung Cancer’s 2025 World Conference on Lung Cancer by Jonathan Goldman, MD of UCLA.

The company plans to discuss the ivonescimab HARMONi data on a conference call scheduled for 8:00 a.m. ET on September 8, 2025. The press release is furnished as Exhibit 99.1 and the accompanying presentation slides for the conference call are furnished as Exhibit 99.2.

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, and exhibit attachments filed with this report.

Understanding 8-K Material Events →

09/08/2025 - 07:45 AM

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): September 7, 2025


Summit Therapeutics Inc.
(Exact Name of Registrant as Specified in Its Charter)

Delaware	001-36866	37-1979717
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(IRS Employer Identification No.)

601 Brickell Key Drive, Suite 1000, Miami, FL		33131
(Address of Principal Executive Offices)		(Zip Code)

Registrant’s Telephone Number, Including Area Code: (305) 203-2034


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 (see General Instruction A.2. below):

☐ 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, $0.01 par value per share	SMMT	The Nasdaq Stock Market LLC

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 September 7, 2025, Summit Therapeutics Inc. (the “Company”) issued a press release announcing the ivonescimab data relating to its global Phase III clinical trial, HARMONi. The data was presented as part of the Presidential Symposium at the International Association for the Study of Lung Cancer’s 2025 World Conference on Lung Cancer by Jonathan Goldman, MD, Professor of Medicine at UCLA in the Hematology/Oncology Division, UCLA Director of Clinical Trials in Thoracic Oncology, Associate Director of Early Drug Development, and Chair of University of California Lung Cancer Consortium on September 7, 2025. A copy of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.

The Company will utilize slides during its conference call scheduled for 8:00am ET on September 8, 2025, discussing the ivonescimab data from HARMONi. A copy of the slides is attached as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated by reference herein.


Item 9.01			Financial Statements and Exhibits.

(d) Exhibits


Exhibit Number			Description
99.1			Press release, dated September 7, 2025
99.2			Presentation Slides for September 8, 2025 Conference Call
104			Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURE

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.


	SUMMIT THERAPEUTICS INC.


Date: September 8, 2025	By:	/s/ Manmeet S. Soni
		Chief Operating Officer, Chief Financial Officer and Director
		(Principal Financial Officer)

Source: View Original Filing on SEC EDGAR

FAQ

What did Summit Therapeutics (SMMT) disclose in this 8-K?

Summit Therapeutics disclosed that it issued a press release announcing ivonescimab data from its global Phase III HARMONi clinical trial and that the data were presented at the International Association for the Study of Lung Cancer’s 2025 World Conference on Lung Cancer.

What is the HARMONi trial mentioned by Summit Therapeutics (SMMT)?

HARMONi is described as a global Phase III clinical trial evaluating ivonescimab. The 8-K notes that new data from this study were announced and presented at the 2025 World Conference on Lung Cancer.

Who presented the ivonescimab HARMONi data for Summit Therapeutics (SMMT)?

The ivonescimab HARMONi data were presented by Jonathan Goldman, MD, Professor of Medicine at UCLA in the Hematology/Oncology Division, UCLA Director of Clinical Trials in Thoracic Oncology, Associate Director of Early Drug Development, and Chair of the University of California Lung Cancer Consortium.

When is Summit Therapeutics’ conference call about the HARMONi data?

Summit Therapeutics scheduled a conference call for 8:00 a.m. ET on September 8, 2025 to discuss the ivonescimab data from the HARMONi Phase III trial.

What exhibits are included with this Summit Therapeutics (SMMT) 8-K?

The 8-K includes Exhibit 99.1, a press release dated September 7, 2025, Exhibit 99.2, presentation slides for the September 8, 2025 conference call, and Exhibit 104, the cover page interactive data file embedded within the Inline XBRL document.

Does this 8-K from Summit Therapeutics (SMMT) include the full ivonescimab HARMONi results?

The 8-K states that the company announced ivonescimab HARMONi data in a press release and presented them at a scientific conference, with the press release and presentation slides filed as Exhibits 99.1 and 99.2, respectively.