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]

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]

Core Insights - Cue Biopharma presented promising clinical data for its lead oncology asset CUE-101 in combination with KEYTRUDA® for treating HPV+ recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) patients, showing an objective response rate (ORR) of 46% and a 12-month overall survival (OS) of 91.3% [1][3] - The company also reported a 67% overall disease control rate (DCR) for its second clinical asset CUE-102 in late-stage pancreatic cancer patients, indicating significant anti-tumor activity [1][5] CUE-101 Clinical Trial Data - CUE-101 demonstrated an ORR of 46% and a DCR of 75% in first-line HPV+ R/M HNSCC patients, significantly outperforming the historical ORR of 19% with pembrolizumab alone [3] - The median overall survival (mOS) for patients treated with CUE-101 was 21.8 months, compared to 12.3 months in historical trials [4] - In patients with low PD-L1 expression (CPS 1-19), the ORR reached 50% [1][3] CUE-102 Clinical Trial Data - CUE-102 showed a 67% overall DCR in late-stage pancreatic cancer patients, including an unconfirmed partial response with a 40% decrease in tumor burden [1][5] - Evidence of selective expansion of WT1-specific T cells was observed, with no dose-limiting toxicities reported during the trial [6][10] Mechanism of Action - The CUE-100 series, including CUE-101 and CUE-102, utilizes a novel mechanism to selectively engage and modulate disease-specific T cells, enhancing the immune response against tumors [8][11] - CUE-101 is designed to activate HPV16 tumor-specific T cells, while CUE-102 targets WT1-specific T cells, both aiming to improve patient outcomes in various cancers [9][10] Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a new class of therapeutic biologics to modulate T cells for cancer and autoimmune diseases [11][12] - The company’s proprietary Immuno-STAT platform aims to harness the body's immune system while minimizing adverse effects associated with traditional therapies [11]

Core Viewpoint - Cue Biopharma, Inc. has announced a public offering of common stock and warrants, aiming to raise approximately $12.0 million before expenses [1]. Group 1: Offering Details - The offering includes 11,564,401 shares of common stock and warrants for 2,891,100 shares, as well as pre-funded warrants for 12,435,599 shares and accompanying warrants for 3,108,900 shares [1]. - The combined public offering price for each common stock and warrant is $0.50, while the pre-funded warrants are priced at $0.499 [1]. - The offering is expected to close around September 30, 2024, pending customary closing conditions [1]. Group 2: Management and Structure - Oppenheimer & Co. Inc. is the sole book-running manager, with Newbridge Securities Corporation acting as co-manager for the offering [2]. - Cue Biopharma is led by an experienced management team and independent Board of Directors with expertise in immunology and immuno-oncology [6]. Group 3: Company Overview - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing a novel class of injectable biologics to engage and modulate disease-specific T cells [5]. - The company's proprietary platform, Immuno-STAT™, aims to harness the immune system's potential without broad systemic immune modulation [5].