# EDGAR Filing Document

**Accession Number:** 0001645460
**File Stem:** 0001193125-25-268135
**Filing Date:** 2025-11
**Character Count:** 23651
**Document Hash:** 020c5de2540e0db2f4a2c349fed6a1d2
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001193125-25-268135.hdr.sgml**: 20251106

**ACCESSION NUMBER**: 0001193125-25-268135

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 13

**CONFORMED PERIOD OF REPORT**: 20251106

**ITEM INFORMATION**: Entry into a Material Definitive Agreement

**ITEM INFORMATION**: Regulation FD Disclosure

**ITEM INFORMATION**: Financial Statements and Exhibits

**FILED AS OF DATE**: 20251106

**DATE AS OF CHANGE**: 20251106

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** Cue Biopharma, Inc.
- **CENTRAL INDEX KEY:** 0001645460
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 473324577
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-38327
- **FILM NUMBER:** 251456267

**BUSINESS ADDRESS:**
- **STREET 1:** 40 GUEST STREET
- **CITY:** BOSTON
- **STATE:** MA
- **ZIP:** 02135
- **BUSINESS PHONE:** 617-949-2680

**MAIL ADDRESS:**
- **STREET 1:** 40 GUEST STREET
- **CITY:** BOSTON
- **STATE:** MA
- **ZIP:** 02135

**FORMER COMPANY:**
- **FORMER CONFORMED NAME:** Imagen Biopharma, Inc.
- **DATE OF NAME CHANGE:** 20150617

?xml version='1.0' encoding='ASCII'? 8-K

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**UNITED STATES**

**SECURITIES AND EXCHANGE COMMISSION**

**WASHINGTON, D.C. 20549**

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**FORM** 8-K

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**CURRENT REPORT**

**Pursuant to Section 13 or 15(d) of**

**The Securities Exchange Act of 1934**

**Date of Report (Date of Earliest Event Reported):** November 6, 2025

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Cue Biopharma, Inc.

**(Exact name of registrant as specified in its charter)**

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| | | |
|:---|:---|:---|
| Delaware | 001-38327 | 47-3324577 |
| **(State or other jurisdiction**<br>**of incorporation)** | **(Commission**<br>**File Number)** | **(IRS Employer**<br>**Identification No.)** |

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| | |
|:---|:---|
| 40 Guest Street<br>Boston**,** Massachusetts | 02135<br>**(Zip Code)** |
| **(Address of principal executive offices)** |  |

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**(**617**)** 949-2680

**(Registrant's telephone number, including area code)**

**(Former name or former address, if changed since last report.)**

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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))

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☐ 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:

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| | | |
|:---|:---|:---|
| **Title of each class** | **Trading<br>Symbol(s)** | **Name of each exchange<br>on which registered** |
| Common Stock, par value $0.001 per share | CUE | Nasdaq **Capital Market** |

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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. ☐

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|:---|:---|
| **Item 1.01.** | **Entry into a Material Definitive Agreement.**<br>|

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On November 6, 2025, ImmunoScape Pte. Ltd. ("IMSCP") exercised its option (the "Option") to obtain licenses to research, develop and commercialize molecules from Cue Biopharma, Inc.'s (the "Company") CUE-100 Series, including CUE-101 and CUE-102, subject to certain exclusions (the licensed series of molecules, the "Licensed Program"), for all oncology indications pursuant to a Collaboration and License Agreement, effective November 6, 2025, between the Company and IMSCP (the "Collaboration and License Agreement"). The licenses include a co-exclusive development license for five years or, if longer, for so long as IMSCP has a specified number of CUE-100 Series molecules under active development and, pursuant to which, the Company retains non-exclusive research rights to support its other programs (the "co-exclusive development license"). The licenses also include an exclusive commercial license to IMSCP for any CUE-100 Series molecule that IMSCP advances to IND-enabling studies while the co-exclusive development license is in effect. The Licensed Program will be further developed and potentially commercialized by IMSCP. The Option was exercised pursuant to an Option Agreement between the Company and IMSCP, dated October 22, 2025 (the "Option Agreement"). In connection with entry into the Option Agreement and IMSCP's exercise of the Option, the Company received an aggregate of $5 million in the fourth quarter of 2025. Pursuant to the Collaboration and License Agreement, the Company is entitled to receive (a) equity of IMSCP equal to 40% of the issued and outstanding equity of IMSCP and additional equity, in the form of warrants, upon certain dilution events in the future, (b) a time-based payment of $5 million in or prior to December 2025, (c) an additional time-based payment of $5 million before the first anniversary of the Option exercise, (d) high single-digit royalties on global net sales and (e) low- to mid-double digit royalties from sublicensing royalties and income. The Collaboration and License Agreement includes customary termination provisions, including IMSCP's ability to terminate the agreement in its entirety on 60 days' advanced written notice to the Company.

The foregoing description is qualified in its entirety by reference to the complete text of the Collaboration and License Agreement, which the Company plans to file as an exhibit to its Annual Report on Form 10-K for the year ending December 31, 2025.

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| | |
|:---|:---|
| **Item 7.01.** | **Regulation FD Disclosure**<br>|

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On November 6, 2025, the Company issued a press release announcing the Collaboration and License Agreement. A copy of the press release is furnished hereto as Exhibit 99.1.

The information in Item 7.01 of this Form 8-K (including Exhibit 99.1) shall not be deemed "filed" for 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, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

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| | |
|:---|:---|
| **Item 9.01.** | **Financial Statements and Exhibits.** |

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(d) Exhibits:

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| | |
|:---|:---|
| **Exhibit**<br>**No.** | **Description** |
| 99.1 | [<u>Press Release dated November 6, 2025</u>](cue-ex99_1.htm) |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |

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**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 Company's potential receipt of certain time-based milestone payments as well as royalty payments on net sales. 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 ability to maintain its collaboration with IMSCP; 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.

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**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.

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| | | |
|:---|:---|:---|
|  | &nbsp;&nbsp;&nbsp;&nbsp;**Cue Biopharma, Inc.** | &nbsp;&nbsp;&nbsp;&nbsp;**Cue Biopharma, Inc.** |
| Date: November 6, 2025 | By: | /s/ Usman Azam |
|  | Name: Usman Azam | Name: Usman Azam |
|  | Title: President and Chief Executive Officer | Title: President and Chief Executive Officer |

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## Exhibit 99.1

![img239719762_0.jpg](img239719762_0.jpg)![img239719762_1.jpg](img239719762_1.jpg)

**Cue Biopharma and ImmunoScape Announce Strategic Collaboration to Develop <br>Breakthrough Cell Therapy Approach for Solid Tumors**

*Exclusive collaboration and license agreement focuses on advancing novel, T cell therapy "Seed-and-Boost" approach exploiting the mechanism of the CUE-100 series of Immuno-STATs®*

*Novel therapeutic approach is designed to enable in vivo expansion and activation of infused T cell receptor engineered T cells (TCR-Ts) to provide durability, tolerability and enhanced clinical benefit while reducing manufacturing complexity*

*Compelling data generated in preclinical models of multiple solid tumors, including pancreatic and ovarian, demonstrates the clinical potential of this novel immunotherapy approach with IND enabling studies on track for 2027 submission*

<br>BOSTON, MA. and SINGAPORE, November 6, 2025 -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics to selectively engage and modulate disease-specific T cells for the treatment of autoimmune disease and cancer, and ImmunoScape, Pte. Ltd, a biotechnology company developing next-generation T cell receptor (TCR)-based therapies in oncology, today announced that they have entered into a collaboration and license agreement to advance a novel in vivo approach to cell therapy for the treatment of solid tumors. Under the agreement, ImmunoScape will develop a novel *Seed-and-Boost* immunotherapy that combines Cue Biopharma's clinically-validated Immuno-STAT T-cell engagers, the CUE-100 series, with ImmunoScape's proprietary TCRs. The combination therapy is designed to overcome core limitations of existing cell therapies with the potential for establishing a breakthrough standard of care with superior anti-tumor activity durable T cell persistence and product scalability.

With this *Seed-and-Boost* approach to immunotherapy, a minimal starting dose of ImmunoScape's tumor-specific TCR-Ts are administered to the patient *(Seed)* followed by the administration of Cue Biopharma's TCR matched IL-2 Immuno-STAT molecules *(Boost*). TCR-selective engagement is designed to enable targeted expansion and activation in the patient while avoiding systemic immune activation and the off-the-shelf Immuno-STAT dosing to allow for precise in vivo modulation of the tumor-specific T cell response to enhance efficacy, persistence and tumor infiltration while mitigating T cell exhaustion. By requiring only small starting numbers of engineered T cells, this strategy simplifies manufacturing and aims to deliver deeper and durable clinical efficacy for patients along with improved tolerability and quality of life. This promising breakthrough approach is supported by a comprehensive preclinical data package from both companies.

The CUE-100 series is a novel class of injectable biologics that leverage the specificity of a TCR, enabling selective engagement and activation of targeted disease-specific T cells. The core protein framework of

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![img239719762_0.jpg](img239719762_0.jpg)![img239719762_1.jpg](img239719762_1.jpg)

the Immuno-STAT molecules facilitates engagement with the TCR, fostering TCR signaling while concurrently delivering Interleukin-2 (IL-2) as the key second costimulatory molecule for selective T cell activation and expansion. The Phase 1 clinical datasets generated from the CUE-100 series programs have demonstrated clinical activity in several metastatic cancers without the significant toxicities that are often caused by traditional immune activating IL-2 delivery.

ImmunoScape has developed an extensive library of highly potent TCRs against a diverse panel of shared tumor-specific targets binding to the world's most prevalent HLA alleles. By utilizing these proprietary TCRs in combination with the CUE-100 series, it is anticipated that the potential of cell therapy to provide durable and effective anti-tumor effects in solid tumors may become a reality with this *Seed-and-Boost* approach.

"We believe this strategic collaboration with ImmunoScape represents a significant development for treating solid tumors with immunotherapy and creating potential value for our shareholders," said Usman Azam, M.D., president and chief executive officer of Cue Biopharma. "It positions the Company to focus on our autoimmune disease programs and continue to advance the Immuno-STAT platform for oncology with our partners at ImmunoScape."

"ImmunoScape is excited to partner with Cue Biopharma to pioneer this novel immunotherapy against solid tumors and potentially provide patients with a promising treatment option," said Michael Fehlings, chief executive officer of ImmunoScape. "Based on our extensive preclinical work, we believe this *Seed- and-Boost* approach will transform T cell therapy for long-term efficacy against a range of solid tumors while avoiding the deleterious side effects of broad immune activation. We aim to transform patients' lives by enabling superior cell therapy and streamlining the patient journey."

Pursuant to the terms of the collaboration, Cue Biopharma is entitled to receive an upfront total payment of $15 million, $10 million in Q4 2025 and $5 million in November of 2026, as well as a 40% equity stake in ImmunoScape. In addition, Cue Biopharma is also eligible for high-single-digit royalty payments on net sales. For further details regarding the terms of the collaboration and license agreement, please refer to the Current Report on Form 8-K filed today by Cue Biopharma.

**About the CUE-100 Series**

The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-major histocompatibility complex (pMHC) molecules along with rationally engineered interleukin 2 (IL-2) molecules. These singular biologics are anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient's body. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies.

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![img239719762_0.jpg](img239719762_0.jpg)![img239719762_1.jpg](img239719762_1.jpg)

**About ImmunoScape**<br> ImmunoScape is a biotechnology company focused on the discovery and development of next-generation T-cell receptor (TCR) cell therapies in the field of oncology. The company's proprietary *Deep Immunomics* technology platform enables highly sensitive, large-scale mining and immune profiling of T cells in cancer patient samples to identify novel, therapeutically relevant TCRs. Located in both Singapore and California, ImmunoScape has developed an extensive and diverse portfolio of highly potent and best-in-class TCRs against a broad array of shared tumor antigens and HLA alleles across the world's population.

For more information, please visit immunoscape.com

**About Cue Biopharma**

Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient's body. The company's proprietary platform, Immuno-STAT® *(Selective Targeting and Alteration of T cells)*, and biologics are designed to harness the curative potential of the body's intrinsic immune system without the adverse effects of broad systemic immune modulation.

Headquartered in Boston, Massachusetts, we are led by an experienced management team with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics.

For more information please visit www.cuebiopharma.com and follow us on X and LinkedIn.

**Cue Biopharma's Cautionary Note Regarding Forward-Looking Statements**

This press release 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 potential benefits of the therapeutic approach to be developed pursuant to the collaboration and license agreement with ImmunoScape; the timing for publication of preclinical data, the advancement of IND-enabling studies and the timing for filing of an IND; the expected benefits for Cue and its shareholders of collaborating with ImmunoScape on the Immuno-STAT platform for oncology; Cue Biopharma's potential receipt of certain development and milestone-based payments as well as royalty payments on net sales; the company's belief that the Immuno-STAT platform stimulates targeted immune modulation through the selective modulation of disease-relevant T cell and the applicability of the company's platform across many cancers and autoimmune diseases; and the company's business strategies, plans and prospects. 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 "believe," "expect," "may," "will," "should," "would," "could," "seek," "intend," "plan," "goal," "project," "estimate," "anticipate," "strategy,"

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![img239719762_0.jpg](img239719762_0.jpg)![img239719762_1.jpg](img239719762_1.jpg)

"future," "likely" or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company's strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the company's actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company's ability to maintain its collaboration with ImmunoScape; the company's ability to shift its focus to its autoimmune assets; the company's limited operating history, limited cash and a history of losses; the company's ability to achieve profitability; potential setbacks in the company's research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or 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; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; its ability to secure required U.S. Food and Drug Administration ("FDA") or other governmental approvals for its product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including possible effects on the company's trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company's reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company's ability to obtain adequate financing to fund its business operations in the future; the company's ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of the company's most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

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![img239719762_0.jpg](img239719762_0.jpg)![img239719762_1.jpg](img239719762_1.jpg)

**Investor Contact** 

Marie Campinell <br>Senior Director, Corporate Communications<br>Cue Biopharma, Inc.

mcampinell@cuebio.com

**Media Contacts**<br> Jonathan Pappas<br>LifeSci Communications

jpappas@lifescicomms.com

Kalyn Schieffer for ImmunoScape<br>kos@anzupartners.com

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