Compass Therapeutics Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits

On April 27, 2026, Compass Therapeutics, Inc. (the “Company”) issued a press release announcing data related to a randomized Phase 2/3 study in patients with biliary tract cancer (“BTC”). The Company will host a webcast today, Monday, April 27, 2026 at 8:00 a.m. ET, to provide a review of the data. Interested parties may register for the call in advance via https://viavid.webcasts.com/starthere.jsp?ei=1761459&tp_key=efc315f5a6.

A copy of the full press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein. A copy of the presentation to be shown at the webcast on April 27, 2026, is attached as Exhibit 99.2 to this Current Report on Form 8-K and incorporated by reference herein. The presentation and a replay of the webcast will also be available on the investor relations section of the Company’s website at https://investors.compasstherapeutics.com/. Information contained on the Company’s website is not incorporated by reference into this Current Report on Form 8-K, and you should not consider any information on, or that can be accessed from, the Company’s website as part of this Current Report on Form 8-K.

The information in this Item 7.01 and Exhibits 99.1 and 99.2 of this Current Report on Form 8-K are furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information in this Item 7.01 and Exhibits 99.1 and 99.2 of this Current Report on Form 8-K shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date of this Current Report on Form 8-K, regardless of any general incorporation language in any such filing.

Tovecimig results in Phase 2/3 Study in the Second Line Setting for Patients with BTC

On April 27, 2026, the Company announced data for COMPANION-002, the Company’s Phase 2/3 randomized trial of tovecimig (formerly CTX-009) in combination with paclitaxel in patients with advanced BTC. The study enrolled 168 adult patients, randomized in a 2:1 ratio to receive tovecimig plus paclitaxel (n=111) or paclitaxel alone (n=57). In April 2025, the Company announced that the study met its primary endpoint of overall response rate (“ORR”). Tovecimig in combination with paclitaxel achieved a 17.1% ORR, including one complete response, compared to a 5.3% ORR for paclitaxel alone, in patients with biliary tract cancer (“BTC”) treated in the second-line setting. The difference in ORR between the two treatment arms, the primary endpoint of the study, was statistically significant (p=0.031), and all responses were assessed by blinded independent central radiology (BICR) review.

The following additional information related to the study was announced on April 27, 2026:

Key Secondary Endpoints:

In the ITT OS analysis, tovecimig in combination with paclitaxel had a median OS of 8.9 months compared to 9.4 months for the control arm, which included 26 patients (46%) who received paclitaxel alone and 31 patients (54%) who crossed over to receive tovecimig in combination with paclitaxel (HR=1.05, p=0.78). In the rank-preserving structural failure time (RPSFT) OS analysis, the combination also had a median OS of 8.9 months compared to 9.4 months for paclitaxel alone (HR=1.13, p=0.65). Though the RPSFT analysis is intended to adjust for crossover, its validity depends on certain assumptions that were not met in this study and thus its results here are largely uninterpretable.

Post Hoc Subset Analyses:

Safety:

In the coming months, Compass intends to meet with the U.S. Food and Drug Administration (FDA) to discuss these data in advance of a planned BLA submission.

Forward-Looking Statements

This Current Report on Form 8-K contains forward-looking statements. Statements that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding Compass's product candidates, including the potential of tovecimig to provide a treatment option for patients with BTC in the second-line setting, additional results of the COMPANION-002 study, and the timing and nature of any regulatory interactions and subsequent approval pathways, including Compass's intention to discuss the data in the COMPANION-002 Randomized Phase 2/3 Study with the FDA in advance of a planned BLA submission, and the expectation to present the complete dataset at a medical conference this year. Such factors include, among others, Compass's ability to raise the additional funding it will need to continue to pursue its business and product development plans, the inherent uncertainties associated with developing product candidates and operating as a development stage company, Compass's ability to identify additional product candidates for development, Compass's ability to develop, complete clinical trials for, obtain approvals for and commercialize any of its product candidates, competition in the industry in which Compass operates and market conditions. These forward-looking statements are made as of the date of this Current Report on Form 8-K, and Compass assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents Compass files with the U.S. Securities and Exchange Commission (SEC) available at www.sec.gov, including without limitation Compass's latest Annual Report on Form 10-K and subsequent filings with the SEC.

(d) Exhibits