Core Viewpoint - Cue Biopharma, Inc. is initiating an underwritten public offering of its common stock and accompanying warrants, subject to market conditions, with no assurance on the completion or terms of the offering [1] Company Overview - Cue Biopharma 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][5] - The company utilizes its proprietary platform, Immuno-STAT™, designed to harness the immune system's potential by selectively modulating disease-specific T cells without broad systemic immune effects [5] Offering Details - Oppenheimer & Co. Inc. is the sole book-running manager for the offering, while Newbridge Securities Corporation serves as co-manager [2] - A shelf registration statement related to the offering was filed with the SEC on May 9, 2023, and declared effective on May 26, 2023 [3] Contact Information - Investor contact is Marie Campinell, Senior Director of Corporate Communications at Cue Biopharma [10]

Group 1 - 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 will host a conference call and webcast on April 15, 2025, at 4:30 p.m. ET to provide a business update [1][2] - Cue Biopharma's proprietary platform, Immuno-STAT™, is designed to harness the body's immune system by selectively modulating disease-specific T cells without broad systemic immune modulation [3] Group 2 - The company is headquartered in Boston, Massachusetts, and is led by a management team with expertise in immunology, protein engineering, and clinical development of protein biologics [4] - Investors can access the conference call via specific phone numbers and a webcast link, with the archived version available for 30 days [2]

Core Viewpoint - Boehringer Ingelheim and Cue Biopharma have entered into a strategic research collaboration and license agreement to develop Cue Biopharma's CUE-501, a differentiated B cell depletion therapy aimed at treating autoimmune diseases [1][3]. Company Overview - Boehringer Ingelheim is a biopharmaceutical company focused on human and animal health, emphasizing innovative therapies for high unmet medical needs, with over 53,500 employees serving in more than 130 markets [5]. - Cue Biopharma is a clinical-stage biopharmaceutical company developing a novel class of injectable biologics designed to selectively engage and modulate disease-specific T cells [6][7]. Collaboration Details - The collaboration aims to leverage Cue Biopharma's proprietary T-cell engager platform to enhance the development of CUE-501, potentially providing a more effective treatment option for patients with autoimmune diseases [3][4]. - Cue Biopharma will receive an upfront payment of $12 million, along with research support payments, and could earn up to approximately $345 million in milestone-based payments and royalties on net sales [4]. Product Candidate - CUE-501 is designed to bind to a B cell specific membrane protein while selectively engaging virus-specific memory killer T cells, allowing for targeted depletion of B cells and reduction of autoimmune and inflammatory processes [2][6]. - The candidate has the potential to provide improved benefits and safety compared to existing therapies targeting B cells, aiming to reach patients earlier in their treatment journey [2][6].

Group 1: Earnings Performance - Cue Biopharma reported a quarterly loss of $0.13 per share, better than the Zacks Consensus Estimate of a loss of $0.16, and improved from a loss of $0.28 per share a year ago, representing an earnings surprise of 18.75% [1] - The company has surpassed consensus EPS estimates in all four of the last quarters [2] - The revenue for the quarter ended December 2024 was $1.58 million, missing the Zacks Consensus Estimate by 5.40%, and down from $1.82 million year-over-year [2] Group 2: Stock Performance and Outlook - Cue Biopharma shares have declined approximately 15.6% since the beginning of the year, compared to a decline of 5.1% for the S&P 500 [3] - The company's earnings outlook is mixed, with the current consensus EPS estimate for the coming quarter at -$0.15 on $2 million in revenues, and -$0.55 on $13.49 million in revenues for the current fiscal year [7] Group 3: Industry Context - The Medical - Biomedical and Genetics industry, to which Cue Biopharma belongs, is currently ranked in the top 27% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]

Core Viewpoint - Cue Biopharma, Inc. has reported its fourth quarter and full year 2024 financial results, highlighting progress in its autoimmune programs and the strategic focus on its Immuno-STAT™ platform, particularly CUE-401 [1][2]. Financial Results Summary Fourth Quarter 2024 - Collaboration revenue decreased to $1.6 million from $1.8 million in Q4 2023, attributed to a prior strategic collaboration with Ono Pharmaceutical [2]. - Research and development expenses were $7.2 million, down from $10.9 million in Q4 2023, mainly due to reduced drug substance manufacturing and clinical trial costs [3]. - General and administrative expenses decreased to $4.0 million from $4.6 million in Q4 2023, primarily due to lower professional fees [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 [4]. - Research and development expenses totaled $36.3 million, down from $40.8 million in 2023, due to decreases in clinical trial costs and employee compensation [5]. - General and administrative expenses were $14.6 million, reduced from $16.7 million in 2023, mainly due to lower employee compensation and professional fees [6]. - As of December 31, 2024, the company had $22.5 million in cash and cash equivalents [6]. Strategic Developments - The company is prioritizing resources on autoimmune programs while advancing clinical data from oncology programs to support strategic partnerships [8]. - Key industry leaders have been appointed to the management team, enhancing expertise in strategic transactions and drug development [8]. - The company has regained worldwide development and commercialization rights for CUE-401, its lead autoimmune program, which has the potential to transform treatment for various autoimmune and inflammatory diseases [8].

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]