GlobeNewswire Inc | Jan 26, 2022 04:01PM EST

January 26, 2022

-- Early data in the combination study of CUE-101 and KEYTRUDA (pembrolizumab) supports synergistic activity; of four patients treated in dose escalation in the 2mg/kg and RP2D 4mg/kg cohorts, two have partial responses (1 confirmed and 1 unconfirmed) and two are manifesting reductions in target lesions -- Updated CUE-101 monotherapy data further enhances confidence in potential as single agent therapeutic with 50% clinical benefit rate reported to datein RP2D (4mg/kg) expansion monotherapytrial and an emerging enhanced overall survival rate that supports the premise that CUE-101 selectively stimulates cancer-relevant CD8+ T cells

CAMBRIDGE, Mass., Jan. 26, 2022 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company engineering a novel class of injectable biologics designed to selectively engage and modulate targeted T cells directly within the patients body, will provide a clinical update during todays conference call and webcastat4:30 p.m. EST. Live and archived versions of the event can be accessed via the Companyswebsite.

Members of theCue Biopharmaexecutive management team will provide an update from the Companys ongoing clinical trials with CUE-101, its lead and representative IL-2 based drug product candidate from the CUE-100 series. CUE-101 is currently in a Phase 1b clinical trial for the treatment of third line and beyond HPV+ recurrent/metastatic head and neck squamous cell carcinoma. The discussion will focus on recent data updates from the Phase 1b monotherapy dose expansion trial and the dose escalation combination trial evaluating CUE-101 front line with Mercks KEYTRUDA (pembrolizumab). Management will also provide an update on the Companys pipeline development progress from the IL-2 based CUE-100 series including CUE-102, with an Investigational New Drug (IND) filing planned for the first quarter of 2022, as well as updates on its strategic objectives and anticipated milestones.

Webcast Details

Wednesday, January 26, 2022 at4:30 p.m. ESTInvestors: 877-407-9208International: 201-493-6784Conference ID: 13726509Webcast: https://viavid.webcasts.com/starthere.jsp?ei=1525411&tp_key=7a7d92f501

AboutCue BiopharmaCue Biopharma, a clinical-stage biopharmaceutical company, is engineering a novel class of injectable biologics to selectively engage and modulate targeted T cells directly within the patients body to transform the treatment of cancer, infectious disease and autoimmune disease. The companys proprietary Immuno-STAT (Selective Targeting and Alteration of T cells) platform is designed to harness the bodys intrinsic immune system without the need for ex vivo manipulation.

Headquartered in Cambridge, Massachusetts, the company is led by an experienced management team and independent Board of Directors with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics.

For more information, visitwww.cuebiopharma.com and follow us on Twitter at https://twitter.com/CueBiopharma.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be covered by the safe harbor created by those sections. Such forward-looking statements include, but are not limited to, those regarding: the companys estimate of the period in which it expects to have cash to fund its operations; the companys belief that the Immuno-STAT platform stimulates targeted immune modulation through the selective engagement of disease-relevant T cells; and the companys business strategies, plans and prospects. Forward-looking statements, which are based on certain assumptions and describe the companys 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, 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 companys strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the companys actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the companys limited operating history, limited cash and a history of losses; the companys ability to achieve profitability; potential setbacks in the companys research and development efforts including negative or inconclusive results from its preclinical studies, 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 COVID-19, including possible effects on the companys trials; negative or inconclusive results from the companys clinical trials or preclinical studies or serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the companys reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the companys ability to obtain adequate financing to fund its business operations in the future; operations and clinical the companys 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 companys 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.

Investor Contact George B. Zavoico, Ph.D.VP, Investor Relations & Corporate Development Cue Biopharma, Inc. gzavoico@cuebio.com

Media ContactDarren Opland, Ph.D.LifeSci Communicationsdarren@lifescicomms.com