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  4. [8-K] Cue Biopharma, Inc. Reports Material Event

$7.5M Boehringer milestone advances Cue Biopharma (CUE) B cell program

Filing Impact
(Moderate)
Filing Sentiment
(Neutral)
Form Type
8-K

Rhea-AI Filing Summary

Cue Biopharma, Inc. reports that partner Boehringer Ingelheim has selected its first compound for lead optimization under their April 2025 collaboration focused on differentiated B cell depletion molecules, including Cue’s CUE-501 candidate. This preclinical milestone triggers a $7.5 million payment to Cue Biopharma, which is expected in May 2026.

The company notes that, despite this milestone, it continues to face risks typical for an early-stage biotech, including limited operating history, limited cash, a history of losses, and a current going concern determination about its ability to fund operations beyond the next twelve months.

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Insights

$7.5M milestone strengthens Cue’s Boehringer tie-up but broader funding risks remain.

Cue Biopharma has reached an early but meaningful step in its collaboration with Boehringer Ingelheim, as Boehringer selected the first compound for lead optimization targeting B cell depletion, including the CUE-501 program. This triggers a $7.5 million preclinical milestone payment expected in May 2026, providing non-dilutive cash.

The filing also reiterates substantial risks: limited operating history, ongoing losses, constrained cash resources, and a current “going concern” status regarding operations beyond the next twelve months. While the milestone validates the collaboration and offers near-term funding relief, longer-term prospects still depend on future data, additional milestones, and access to financing.

Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Milestone payment $7.5 million Preclinical milestone from Boehringer Ingelheim triggered by lead optimization selection, expected May 2026
Notice date April 1, 2026 Date Cue Biopharma received notice of Boehringer’s lead optimization selection
Collaboration agreement date April 10, 2025 Date of Collaboration and License Agreement with Boehringer Ingelheim
Product candidate CUE-501 Cue Biopharma product candidate included in B cell depletion collaboration
Expected receipt month May 2026 Expected timing of the $7.5 million milestone payment
lead optimization technical
"approved selection of its first compound for lead optimization under the Collaboration and License Agreement"
A stage in drug discovery where promising chemical or biological candidates (“leads”) are systematically changed and tested to make them more potent, safer, longer-lasting, and easier to turn into a medicine. Think of it like sharpening and tuning a prototype tool until it reliably does the job. For investors, successful lead optimization raises the chance a candidate will enter clinical trials, shortens development time, reduces later-stage failure risk, and increases potential value for partners or buyers.
preclinical milestone financial
"This preclinical milestone event triggers a $7.5 million payment to the Company"
A preclinical milestone is a specific, measurable achievement reached during laboratory or animal testing of a drug, device, or therapy before it is tried in humans. Investors pay attention because these milestones reduce scientific uncertainty, unlock staged payments from partners or investors, and increase the project’s value much like a working prototype test increases confidence that a product can be commercialized.
B cell depletion molecules technical
"for the research, development and commercialization of differentiated B cell depletion molecules"
CUE-501 product candidate technical
"including the Company’s CUE-501 product candidate"
going concern financial
"successfully remediate its current “going concern” determination that it does not have sufficient capital"
A going concern is a business that is expected to continue its operations and meet its obligations for the foreseeable future, rather than shutting down or selling off assets. This assumption matters to investors because it indicates stability and ongoing profitability, making the business a more reliable investment. Think of it as believing a restaurant will stay open and serve customers, rather than closing down suddenly.
forward-looking statements regulatory
"contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995"
Forward-looking statements are predictions or plans that companies share about what they expect to happen in the future, like estimating sales or profits. They matter because they help investors understand a company's outlook, but since they are based on guesses and assumptions, they can sometimes be wrong.
Understanding 8-K Material Events →
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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): April 1, 2026

Cue Biopharma, Inc.

(Exact name of Registrant as specified in its charter)

Delaware

001-38327

47-3324577

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(IRS Employer

Identification No.)

40 Guest Street

Boston, Massachusetts

02135

(Zip Code)

(Address of principal executive offices)

 

(617) 949-2680

(Registrant’s telephone number, including area code)

 

(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, par value $0.001 per share

CUE

Nasdaq Capital 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 April 1, 2026, Cue Biopharma, Inc. (the “Company”) received notice from Boehringer Ingelheim that Boehringer Ingelheim had approved selection of its first compound for lead optimization under the Collaboration and License Agreement entered into with Boehringer Ingelheim on April 10, 2025 for the research, development and commercialization of differentiated B cell depletion molecules, including the Company’s CUE-501 product candidate. This preclinical milestone event triggers a $7.5 million payment to the Company, which is expected to be received in May 2026.

 

Cautionary Note Regarding Forward Looking Statements

 

This Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the timing of a preclinical milestone payment expected to be received by the Company. Forward-looking statements, which are based on certain assumptions and describe the Company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “goal,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “seek,” “strategy,” “future,” “vision,” “should,” “target,” “will,” “would,” “likely” or other comparable terms, although not all forward-looking statements contain these identifying words.

 

Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, risks associated with the Company’s limited operating history, limited cash and a history of losses; the Company’s ability to achieve profitability; the Company’s ability to obtain adequate financing to fund its business operations in the future; the Company’s ability to successfully remediate its current “going concern” determination that it does not have sufficient capital on hand to continue operations beyond the next twelve months; the Company’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; potential setbacks in its research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials; and the Company’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates. For a discussion of other risks and uncertainties, and other important factors, any of which could cause the Company’s actual results to differ from those contained in the forward-looking statements, see the “Risk Factors” section in the Company’s most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q filed with the SEC. In addition, the forward-looking statements included in this Current Report on Form 8-K represent the Company’s views as of the date hereof and should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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.

Cue Biopharma, Inc.

Date: April 7, 2026

By:

/s/ Lucinda Warren

Name: Lucinda Warren

Title: Interim President and Chief Executive Officer

 

 

Source: View Original Filing on SEC EDGAR

FAQ

What milestone did Cue Biopharma (CUE) achieve with Boehringer Ingelheim?

Cue Biopharma announced that Boehringer Ingelheim selected its first compound for lead optimization under their collaboration. The program targets differentiated B cell depletion molecules, including Cue’s CUE-501 candidate, marking tangible progress in the partnership and advancing the project further along the preclinical development pathway.

How much is Cue Biopharma (CUE) receiving from the Boehringer milestone?

The company will receive a $7.5 million preclinical milestone payment from Boehringer Ingelheim. This payment is triggered by the selection of the first compound for lead optimization and is described as non-product revenue that can help support Cue Biopharma’s ongoing research and development activities.

When does Cue Biopharma (CUE) expect to receive the $7.5 million payment?

Cue Biopharma expects to receive the $7.5 million milestone payment in May 2026. The timing is tied to Boehringer Ingelheim’s approval of the first compound for lead optimization, which occurred on April 1, 2026, under their existing collaboration and license agreement signed in April 2025.

What is the focus of Cue Biopharma’s collaboration with Boehringer Ingelheim?

The collaboration centers on research, development, and commercialization of differentiated B cell depletion molecules. It includes Cue Biopharma’s CUE-501 product candidate and aims to develop novel therapies targeting B cells, which play key roles in various immune-mediated diseases and certain cancers, subject to successful development.

Does Cue Biopharma (CUE) still face going concern risks after this milestone?

Yes. Despite the $7.5 million milestone, Cue Biopharma reiterates a current going concern determination. The company highlights limited cash, a history of losses, and the need to obtain additional financing to continue operations beyond the next twelve months, alongside usual early-stage biotech development risks.

What risks does Cue Biopharma (CUE) highlight in connection with this update?

Cue Biopharma points to risks including limited operating history, limited cash, recurring losses, reliance on external partners, and potential setbacks in preclinical and clinical development. It also notes a going concern determination about funding operations beyond the next year, emphasizing significant uncertainty around future performance.

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