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Cue Biopharma, Inc., a clinical-stage biopharmaceutical company, develops biologic drugs for the selective modulation of the human immune system to treat a range of cancers, chronic infectious diseases, and autoimmune disorders. Its lead drug candidate is CUE-101, a fusion protein biologic that is in Phase 1b clinical trial designed to target and activate antigen-specific T cells for human papilloma virus-driven cancers. The company offers CUE-102, a fusion protein biologic to target and activate antigen-specific T cells to fight cancers; CUE-103 a CUE-100 series Immuno-STAT targeting the KRAS G12V mutation, including colorectal carcinoma, lung cancer, and pancreatic cancer; CUE-200 that focuses on cell surface receptors, including CD80 and/or 4-1BBL to address T cell exhaustion associated with chronic infections; and CUE-300 and CUE-400 framework to target various autoimmune diseases. Cue Biopharma, Inc. has collaboration agreements with Merck Sharp & Dohme Corp. for the research and development of its proprietary biologics that target various autoimmune disease indications; LG Chem Life Sciences for the development of Immuno-STATs focused on the field of oncology; and Albert Einstein College of Medicine. The company was formerly known as Imagen Biopharma, Inc. and changed its name to Cue Biopharma, Inc. in October 2016. Cue Biopharma, Inc. was incorporated in 2014 and is headquartered in Cambridge, Massachusetts.

Cue Biopharma, Inc.

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BOSTON, AUG. 13, 2025 (GLOBE NEWSWIRE) -- 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, ANNOUNCED TODAY THE INITIATION OF AN INVESTIGATOR SPONSORED TRIAL (IST) IN RGBM AT THE DFCI WITH THE FIRST PATIENT IN THE TRIAL HAVING BEEN DOSED WITH CUE-102. THE TRIAL (NCT06917885) IS A PHASE 1B, OPEN-LABEL STUDY OF ADJUVANT CUE-102, THE COMPANY'S DRUG PRODUCT CANDIDATE TARGETING WILMS' TUMOR 1 PROTEIN (WT1) EXPRESSING CANCERS. THE PRINCIPAL INVESTIGATOR OF THE PHASE 1B TRIAL, DAVID A. REARDON, MD, IS THE CLINICAL DIRECTOR OF THE CENTER FOR NEURO-ONCOLOGY AT DFCI AND A LEADER IN THE FIELD OF IMMUNOTHERAPY FOR THE TREATMENT OF BRAIN CANCER. THE GOAL OF THE STUDY IS TO EVALUATE THE TOLERABILITY AND CLINICAL ACTIVITY OF CUE-102 IN PATIENTS WITH GBM AT FIRST RECURRENCE.

CUE BIOPHARMAANNOUNCES INITIATION OF INVESTIGATOR SPONSORED TRIAL OF CUE-102 IN RECURRENT GLIOBLASTOMA MULTIFORME

BOSTON, AUG. 12, 2025 (GLOBE NEWSWIRE) -- 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, TODAY PROVIDED A BUSINESS AND FINANCIAL UPDATE FOR THE SECOND QUARTER 2025.

CUE BIOPHARMAREPORTS SECOND QUARTER 2025 FINANCIAL RESULTS AND RECENT BUSINESS HIGHLIGHTS

ADDITIONAL COMPLETE RESPONSE (CR) OBSERVED IN PATIENT WITH MULTIPLE TUMORS CONFIRMED OVERALL RESPONSE RATE (ORR) OF 50% IN PATIENTS WITH COMBINED POSITIVE SCORE (CPS) 1, INCLUDING 50% ORR IN PATIENTS WITH LOW CPS (1-19) 12-MONTH OVERALL SURVIVAL OF 88% AND MEDIAN OVERALL SURVIVAL (MOS) OF 32 MONTHS BOSTON, JULY 16, 2025 (GLOBE NEWSWIRE) -- 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, TODAY PROVIDED A CLINICAL UPDATE ON ITS MOST ADVANCED ASSET, CUE-101, REPRESENTATIVE OF THE CUE-100 SERIES. WE ARE EXCITED TO REPORT AN ADDITIONAL CR IN A PATIENT THAT HAD RECURRENT METASTATIC HPV+ HEAD AND NECK SQUAMOUS CELL CARCINOMA (HNSCC) TREATED WITH CUE-101 IN COMBINATION WITH PEMBROLIZUMAB (KEYTRUDA), SAID MATTEO LEVISETTI, CHIEF MEDICAL OFFICER AT CUE BIOPHARMA.

CUE BIOPHARMA REPORTS NEW COMPLETE RESPONSE AND CONFIRMED 50% OVERALL RESPONSE RATE IN ONGOING PHASE 1 TRIAL OF CUE-101 AND PEMBROLIZUMAB IN RECURRENT/METASTATIC HPV+ HEAD AND NECK CANCER

ORR OF 50% IN TREATMENT-NAVE PATIENTS WITH HPV+ R/M HNSCC 12-MONTH LANDMARK SURVIVAL OF 88% AND MOS OF 32 MONTHS

CUE BIOPHARMA PROVIDES UPDATE ON MOST ADVANCED CLINICAL STAGE ASSET, CUE-101, PRESENTED BY DR. DIMITRIOS COLEVAS AT THE DAVA 4TH HAWAII GLOBAL SUMMIT ON THORACIC MALIGNANCIES

CUE-401, A FIRST-IN-CLASS BISPECIFIC MOLECULE DESIGNED TO INDUCE AND EXPAND TREGS IN VIVO THROUGH THE CO-ACTIVITY OF TRANSFORMING TGF- AND A MODIFIED VARIANT OF IL-2 CUE-401, A FIRST-IN-CLASS BISPECIFIC MOLECULE DESIGNED TO INDUCE AND EXPAND TREGS IN VIVO THROUGH THE CO-ACTIVITY OF TRANSFORMING TGF- AND A MODIFIED VARIANT OF IL-2

CUE BIOPHARMA RECEIVES FDA FEEDBACK ON PRE-IND BRIEFING DOCUMENT REINFORCING COMPANY'S INTENTION TO ADVANCE IND SUBMISSION FOR CUE-401 TO ADDRESS UNMET NEED IN THE TREATMENT OF AUTOIMMUNE DISEASE

ANNOUNCED BOEHRINGER INGELHEIM STRATEGIC COLLABORATION AND LICENSE AGREEMENT FOR CUE-501, INCLUDING AN UPFRONT PAYMENT OF $12 MILLION AND ~$345 MILLION IN POTENTIAL MILESTONE PAYMENTS

CUE BIOPHARMAREPORTS FIRST QUARTER 2025 FINANCIAL RESULTS AND RECENT BUSINESS HIGHLIGHTS

BOSTON, MAY 05, 2025 (GLOBE NEWSWIRE) -- 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, TODAY ANNOUNCED THAT IT WILL PARTICIPATE IN A FIRESIDE CHAT ATTHE CITIZENS LIFE SCIENCES CONFERENCEBEING HELD INNEW YORK,MAY 7-8, 2025.

CUE BIOPHARMA TO PARTICIPATE IN FIRESIDE CHAT AT THE CITIZENS LIFE SCIENCES CONFERENCE

INGELHEIM, GERMANY, AND BOSTON, MA, USA, APRIL 14, 2025  BOEHRINGER INGELHEIM AND CUE BIOPHARMA, INC. (NASDAQ: CUE) TODAY ANNOUNCED A STRATEGIC RESEARCH COLLABORATION AND LICENSE AGREEMENT TO DEVELOP AND COMMERCIALIZE CUE BIOPHARMA'S CUE-501 PRODUCT CANDIDATE, A DIFFERENTIATED B CELL DEPLETION THERAPY FOR AUTOIMMUNE DISEASES. CUE BIOPHARMA IS A CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY DEVELOPING A NOVEL CLASS OF THERAPEUTIC BIOLOGICS TO SELECTIVELY ENGAGE AND MODULATE DISEASE-SPECIFIC T CELLS FOR THE POTENTIAL TREATMENT OF AUTOIMMUNE AND INFLAMMATORY DISEASES.

BOEHRINGER INGELHEIM AND CUE BIOPHARMA PARTNER TO DEVELOP NEXT-GENERATION TREATMENT FOR AUTOIMMUNE AND INFLAMMATORY DISEASES

BOSTON, APRIL 14, 2025 (GLOBE NEWSWIRE) -- 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 CANCER AND AUTOIMMUNE DISEASE, TODAY ANNOUNCED THE PRICING OF AN UNDERWRITTEN PUBLIC OFFERING OF (I) 13,530,780 SHARES OF ITS COMMON STOCK AND ACCOMPANYING COMMON STOCK WARRANTS TO PURCHASE AN AGGREGATE OF 3,382,695 SHARES OF COMMON STOCK AND, (II) TO CERTAIN INVESTORS IN LIEU OF COMMON STOCK, PRE-FUNDED WARRANTS TO PURCHASE 11,469,216 SHARES OF COMMON STOCK AND ACCOMPANYING COMMON STOCK WARRANTS TO PURCHASE AN AGGREGATE OF 2,867,304 SHARES OF COMMON STOCK. EACH SHARE OF COMMON STOCK AND ACCOMPANYING COMMON STOCK WARRANT ARE BEING SOLD TOGETHER AT A COMBINED PUBLIC OFFERING PRICE OF $0.79, AND EACH PRE-FUNDED WARRANT AND ACCOMPANYING COMMON STOCK WARRANT ARE BEING SOLD TOGETHER AT A COMBINED PUBLIC OFFERING PRICE OF $0.789. THE AGGREGATE GROSS PROCEEDS OF THE OFFERING ARE EXPECTED TO BE APPROXIMATELY $20 MILLION, BEFORE DEDUCTING UNDERWRITING DISCOUNTS AND COMMISSIONS AND OTHER OFFERING EXPENSES. EACH PRE-FUNDED WARRANT WILL HAVE AN EXERCISE PRICE OF $0.001 PER SHARE, WILL BE EXERCISABLE IMMEDIATELY AND WILL BE EXERCISABLE UNTIL ALL OF THE PRE-FUNDED WARRANTS ARE EXERCISED IN FULL. EACH COMMON STOCK WARRANT WILL HAVE AN EXERCISE PRICE OF $0.79 PER SHARE, WILL BE EXERCISABLE IMMEDIATELY AND WILL EXPIRE FIVE YEARS FROM THE DATE OF ISSUANCE. THE OFFERING IS EXPECTED TO CLOSE ON OR ABOUT APRIL 16, 2025, SUBJECT TO SATISFACTION OF CUSTOMARY CLOSING CONDITIONS. ALL OF THE SECURITIES ARE BEING OFFERED BY CUE BIOPHARMA.

CUE BIOPHARMA ANNOUNCES PRICING OF APPROXIMATELY $20 MILLION PUBLIC OFFERING

BOSTON, APRIL 14, 2025 (GLOBE NEWSWIRE) -- 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 CANCER AND AUTOIMMUNE DISEASE, TODAY ANNOUNCED THAT IT IS COMMENCING AN UNDERWRITTEN PUBLIC OFFERING OF SHARES OF ITS COMMON STOCK (OR PRE-FUNDED WARRANTS TO PURCHASE COMMON STOCK IN LIEU THEREOF) AND ACCOMPANYING WARRANTS TO PURCHASE SHARES OF COMMON STOCK. THE OFFERING IS SUBJECT TO MARKET AND OTHER CONDITIONS, AND THERE CAN BE NO ASSURANCE AS TO WHETHER OR WHEN THE OFFERING MAY BE COMPLETED OR AS TO THE ACTUAL SIZE OR TERMS OF THE OFFERING. ALL OF THE SECURITIES ARE BEING OFFERED BY CUE BIOPHARMA.

CUE BIOPHARMA ANNOUNCES PROPOSED PUBLIC OFFERING

BOSTON, APRIL 14, 2025 (GLOBE NEWSWIRE) -- 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 CANCER AND AUTOIMMUNE DISEASE, TODAY ANNOUNCED THAT IT WILL HOST A CONFERENCE CALL AND WEBCAST TO PROVIDE A BUSINESS UPDATE ON TUESDAY, APRIL 15, 2025 AT 4:30 P.M. ET.

CUE BIOPHARMA TO HOST BUSINESS UPDATE CALL AND WEBCAST

INGELHEIM, GERMANY AND BOSTON, APRIL 14, 2025 (GLOBE NEWSWIRE) -- BOEHRINGER INGELHEIM AND CUE BIOPHARMA, INC. (NASDAQ: CUE) TODAY ANNOUNCED A STRATEGIC RESEARCH COLLABORATION AND LICENSE AGREEMENT TO DEVELOP AND COMMERCIALIZE CUE BIOPHARMA'S CUE-501 PRODUCT CANDIDATE, A DIFFERENTIATED B CELL DEPLETION THERAPY FOR AUTOIMMUNE DISEASES. CUE BIOPHARMA IS A CLINICAL-STAGE BIOPHARMACEUTICAL COMPANY DEVELOPING A NOVEL CLASS OF THERAPEUTIC BIOLOGICS TO SELECTIVELY ENGAGE AND MODULATE DISEASE-SPECIFIC T CELLS FOR THE POTENTIAL TREATMENT OF AUTOIMMUNE AND INFLAMMATORY DISEASES.

Cue Biopharma, Inc.

CUE

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Cue Biopharma, Inc.

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