Partnership bolsters Boehringer's autoimmune and inflammatory disease pipeline portfolio aiming to tackle areas of high unmet patient need.The agreement focuses on further research and development of a novel, first-in-class bispecific compound for T cell mediated targeted depletion of specific B cells to address autoimmune and inflammatory diseases.The candidate compound has the potential to reach patients with autoimmune diseases earlier in their treatment journey and achieve long-term disease control by r ...

Cue Biopharma, Inc. (CUE) came out with a quarterly loss of $0.13 per share versus the Zacks Consensus Estimate of a loss of $0.16. This compares to loss of $0.28 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 18.75%. A quarter ago, it was expected that this company would post a loss of $0.20 per share when it actually produced a loss of $0.17, delivering a surprise of 15%. Over the last four quarters, the company has surpas ...

Research and development expenses were $7.2 million and $10.9 million for the three months ended December 31, 2024 and 2023, respectively. The decrease was primarily due to decreases in both drug substance manufacturing and clinical trial costs. BOSTON, March 31, 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 au ...

Revenue - Collaboration revenue for Q4 2024 was $1.6 million, a decrease from $1.8 million in Q4 2023, attributed to a prior strategic collaboration with Ono Pharmaceutical[3] - Full year 2024 collaboration revenue increased to $9.3 million from $5.5 million in 2023, driven by the strategic collaboration with Ono Pharmaceutical[5] Research and Development Expenses - Research and development expenses decreased to $7.2 million in Q4 2024 from $10.9 million in Q4 2023, primarily due to reduced drug substance manufacturing and clinical trial costs[4] - Full year 2024 research and development expenses were $36.3 million, down from $40.8 million in 2023, mainly due to lower clinical trial costs and employee compensation[6] General and Administrative Expenses - General and administrative expenses for Q4 2024 were $4.0 million, down from $4.6 million in Q4 2023, primarily due to reduced professional fees[4] Financial Position - As of December 31, 2024, the company had $22.5 million in cash and cash equivalents, a decrease from $48.5 million in 2023[7] Strategic Developments - The company successfully regained worldwide development and commercialization rights for CUE-401, its lead autoimmune program[2] - The company advanced research on CUE-501, demonstrating potential to harness anti-viral specific T cells against pathogenic cells[2] - The management team was strengthened with the appointment of key industry leaders, enhancing strategic capabilities[2] - The company plans to announce a business update call and webcast in the coming weeks[2]

For the Fiscal Year Ended December 31, 2024 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | 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 | ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transi ...

Company Overview - Cue Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing a novel class of therapeutic biologics aimed at selectively engaging and modulating disease-specific T cells for cancer and autoimmune disease treatment [1][3] - The company utilizes its proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells), to harness the immune system's potential while minimizing adverse effects associated with broad systemic immune modulation [3] Upcoming Event - Cue Biopharma will participate in an unplugged fireside discussion at the Piper Sandler 36th Annual Healthcare Conference in New York from December 3-5, 2024 [1] - The discussion is scheduled for December 4, 2024, from 9 a.m. to 9:25 a.m. EST, where the company will provide updates on recent clinical and preclinical programs, as well as strategic business and partnering objectives [2] Management and Expertise - The company is headquartered in Boston, Massachusetts, and is led by an experienced management team and independent Board of Directors with extensive expertise in immunology, immuno-oncology, and the clinical development of protein biologics [4]

Group 1 - Cue Biopharma, Inc. reported a quarterly loss of $0.17 per share, better than the Zacks Consensus Estimate of a loss of $0.20, and an improvement from a loss of $0.24 per share a year ago, representing an earnings surprise of 15% [1] - The company posted revenues of $3.34 million for the quarter ended September 2024, exceeding the Zacks Consensus Estimate by 205.22%, compared to year-ago revenues of $2.1 million [2] - Cue Biopharma shares have declined approximately 43.2% since the beginning of the year, contrasting with the S&P 500's gain of 25.5% [3] Group 2 - The earnings outlook for Cue Biopharma is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The estimate revisions trend for Cue Biopharma is currently favorable, leading to a Zacks Rank 2 (Buy) for the stock, indicating expected outperformance in the near future [6] - The current consensus EPS estimate for the upcoming quarter is -$0.16 on revenues of $6 million, and -$0.73 on revenues of $11.48 million for the current fiscal year [7] Group 3 - The Medical - Biomedical and Genetics industry, to which Cue Biopharma belongs, is currently ranked in the top 29% of over 250 Zacks industries, suggesting a positive outlook for stocks within this sector [8]

Core Insights - Cue Biopharma, Inc. provided a business and financial update for Q3 2024, highlighting advancements in clinical trials and financial performance [1] Recent Business Highlights - Positive updated data from Phase 1 trials of CUE-101 and CUE-102 presented at SITC 2024, showing an objective response rate (ORR) of 46% and a 12-month overall survival (OS) of 91.3% in first-line HPV+ R/M HNSCC patients [2] - CUE-102 demonstrated a disease control rate (DCR) of 67% in late-stage pancreatic cancer patients, with a 40% decrease in tumor burden [2] - The company announced a public offering priced at $12 million and appointed Lucinda Warren as Chief Business Officer [2] Financial Results - Collaboration revenue increased by $1.2 million to $3.3 million for Q3 2024, driven by the Ono Collaboration and Option Agreement [3] - Research and development expenses decreased by $0.5 million to $9.4 million for Q3 2024, attributed to lower clinical trial costs [4] - General and administrative expenses decreased by $0.7 million to $2.9 million for Q3 2024, mainly due to reduced employee compensation [5] - As of September 30, 2024, the company had approximately $32.4 million in cash and cash equivalents, down from $48.5 million at the end of 2023 [9] Summary of Financial Performance - For the nine months ended September 30, 2024, collaboration revenue increased by $4.0 million to $7.7 million [6] - Research and development expenses decreased by $0.8 million to $29.1 million for the same period [7] - General and administrative expenses decreased by $1.5 million to $10.6 million for the nine months ended September 30, 2024 [8] - The net loss for Q3 2024 was $8.66 million, compared to a net loss of $11.00 million in Q3 2023 [10]

Drug Development and Clinical Trials - Cue Biopharma is developing a novel class of therapeutic biologics targeting disease-specific T cells, focusing on cancer and autoimmune diseases, with approximately 20 million new cancer diagnoses globally each year [129]. - The company's lead oncology candidates, CUE-101 and CUE-102, are in clinical development, with CUE-101 showing a median overall survival (mOS) of 21.8 months in patients treated in combination with KEYTRUDA, compared to 12.3 months with KEYTRUDA alone [134][136]. - CUE-101 has demonstrated an objective response rate (ORR) of 46% and a disease control rate of 75% in ongoing trials, significantly higher than the historical ORR of 19% for KEYTRUDA [134]. - CUE-102 is currently in a Phase 1 trial for late-line treatment of WT1+ cancers, with preclinical data showing selective expansion of WT1-specific CD8 T cells [143]. - The ongoing clinical data for CUE-101 and CUE-102 is expected to bolster the potential for future drug candidates addressing a broad range of cancers [132]. - The company plans to initiate a Phase 2 trial for CUE-101, with an interim analysis of ORR anticipated approximately 14 months after the first patient is dosed [140][141]. - CUE-102 demonstrated a 34% reduction in tumor burden for a gastric cancer patient at week 36, and a 40% reduction for a pancreatic cancer patient, indicating significant anti-tumor activity [144][149]. - The disease control rate for late-stage pancreatic cancer patients treated with CUE-102 is 41%, with a higher rate of 67% for patients receiving doses of 2 mg/kg and 4 mg/kg [149]. - CUE-401 is designed to selectively induce and expand regulatory T cells (Tregs) for chronic autoimmune diseases, showing promising preclinical results in suppressing self-reactive T cells [153][154]. - The CUE-500 series aims to selectively deplete autoreactive B cells using existing protective anti-viral T cell repertoire, with CUE-501 showing effective B cell killing in preclinical studies [156][157]. - CUE-501 is anticipated to have an improved safety profile compared to pan T cell engagers, with lower production of inflammatory cytokines [157]. - The company plans to provide updates on the CUE-501 program in Q4 2024, with lead candidate selection expected in Q1 2025 [157]. - The company is strategically prioritizing autoimmune programs while continuing to follow patients treated with CUE-102, with further updates expected in Q4 2024 [150]. Financial Performance and Revenue - Collaboration revenue increased by $1.2 million to $3.3 million for the three months ended September 30, 2024, from $2.1 million for the same period in 2023, primarily due to the Ono Collaboration and Option Agreement [189]. - For the nine months ended September 30, 2024, collaboration revenue rose by $4.0 million to $7.7 million, compared to $3.7 million for the same period in 2023, also driven by the Ono Collaboration and Option Agreement [189]. - The company recognized revenue of $0.05 million related to the LG Chem Collaboration Agreement for the nine months ended September 30, 2024, with a total of $19.9 million in collaboration revenue recorded since the agreement began [175]. - The company earned a $2.5 million milestone payment for the FDA's acceptance of the IND for CUE-101 under the LG Chem Collaboration Agreement [174]. - The Ono Collaboration and Option Agreement includes potential milestone payments up to an aggregate of $220 million, along with tiered royalties on sales [178]. Expenses and Cost Management - General and administrative expenses decreased by $0.7 million to $2.9 million for the three months ended September 30, 2024, from $3.6 million in the same period in 2023, mainly due to reduced employee compensation [190]. - For the nine months ended September 30, 2024, general and administrative expenses decreased by $1.5 million to $10.6 million, down from $12.1 million in the same period in 2023, attributed to lower employee compensation [190]. - Research and development expenses decreased by $0.5 million to $9.4 million for the three months ended September 30, 2024, from $9.9 million in the same period in 2023, primarily due to lower clinical trial costs [191]. - For the nine months ended September 30, 2024, research and development expenses decreased by $0.8 million to $29.1 million, compared to $29.9 million for the same period in 2023, mainly due to lower clinical trial costs [191]. Capital and Funding - Cash and cash equivalents totaled $32.4 million as of September 30, 2024, available to fund ongoing business activities [195]. - Net cash used in operating activities totaled $27.3 million for the nine months ended September 30, 2024, compared to $29.0 million for the same period in 2023, a decrease of $1.7 million [210]. - Net cash provided by financing activities totaled $11.2 million for the nine months ended September 30, 2024, compared to $7.1 million for the same period in 2023, an increase of $4.1 million [212]. - The company expects to raise additional capital to fund future operations and remain a going concern, indicating substantial doubt about its ability to continue [209]. - The company needs to raise additional capital or incur debt to fund future operations, with the ability to do so dependent on external financial, economic, and market conditions [218]. - The company may have to delay, reduce, or eliminate product development or commercialization efforts if unable to raise necessary funds, which could adversely affect business prospects [218]. - The company expects to finance cash needs through public or private equity offerings, debt financings, collaborations, and grants, but this may dilute current stockholders' ownership [220]. - If unable to raise adequate funds, the company may have to curtail technology development or operations, potentially leading to business failure [221]. - The company recorded net proceeds from a September 2024 offering of $10.8 million after deducting underwriting discounts and commissions [205]. - The company has financed its working capital primarily through equity offerings and collaborations, including cash received from Merck Sharp & Dohme Corp., LG Chem, and Ono [195]. Organizational Changes and Strategic Direction - The company completed an organizational restructuring in July 2024, resulting in an approximate 25% reduction in its workforce to strengthen operational efficiencies [216]. - The strategic restructuring aims to enhance operational efficiencies and support the development of both oncology and autoimmune programs [132]. - The company aims to establish strategic partnerships to enhance resource capabilities and fully exploit its technology platform in oncology and autoimmune disease [161]. - There were no material changes to the company's contractual obligations and commitments as of September 30, 2024, compared to December 31, 2023 [222]. - The company faces various factors affecting future capital requirements, including clinical trial costs, regulatory approval outcomes, and commercialization success [219]. - The costs associated with operating as a public company and potential disputes with collaborators could impact financial conditions [223]. - The company is not required to provide market risk disclosures as a smaller reporting company [224].

Core Insights - Cue Biopharma announces the appointment of Daniel Baker, M.D., as interim chief development officer (CDO) effective November 25, 2024, while Anish Suri, Ph.D., transitions to principal research and immunology advisor [1][2] - The organizational changes aim to enhance the company's growth and focus on advancing its drug pipeline in oncology and autoimmunity [2][3] Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company developing a novel class of therapeutic biologics designed to selectively engage and modulate disease-specific T cells for cancer and autoimmune disease treatment [1][5] - The company's proprietary platform, Immuno-STAT™, aims to harness the body's immune system without broad systemic immune modulation [5] Leadership Experience - Dr. Daniel Baker brings over 20 years of drug development experience, including significant roles at Johnson & Johnson, where he oversaw numerous Phase I-III trials leading to over 15 regulatory approvals [2][3] - Dr. Baker's previous positions include CEO and founder of Kira Therapeutics and Executive Director at Galapagos Therapeutics [2] Strategic Focus - The company aims to leverage Dr. Baker's expertise in immunotherapeutics to enhance clinical development and registrational strategies [3][4] - The transition is expected to strengthen the company's mission to deliver novel immunotherapies to patients [3]