Cue Biopharma, Inc. (NASDAQ:CUE) Q4 2019 Earnings Conference Call March 17, 2020 4:30 PM ET Company Participants Ashley Robinson - IR Dan Passeri - President and CEO Anish Suri - Chief Scientific Officer Ken Pienta - Chief Medical Officer Kerri-Ann Millar - VP of Finance and Principal Accounting and Finance Officer Conference Call Participants Stephen Willey - Stifel Boris Peaker - Cowen and Company Mark Breidenbach - Oppenheimer & Co. Reni Benjamin - JMP Securities Madhu Kumar - Baird Operator Greeting and ...

Product Development and Clinical Trials - Cue Biopharma's lead product candidate, CUE-101, is currently in a Phase 1 clinical trial for HPV16-driven recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) and has shown activation of HPV-specific T cells from human blood[16][16]. - CUE-101 is designed to activate tumor-specific T cells while minimizing systemic activation of other T cell populations, potentially reducing dose-limiting toxicities associated with current IL-2 therapies[33][33]. - The Phase 1 clinical trial for CUE-101 began in September 2019, focusing on recurrent/metastatic head and neck squamous cell carcinoma (HNSCC), with plans for a combination trial with checkpoint inhibition therapy in late 2020[49]. - CUE-102 targets the Wilms' Tumor protein (WT1) and aims to develop two therapeutic molecules for different HLA alleles, expanding the patient population reach[51][53]. - The CUE-200 framework is being developed to enhance T cell activation for chronic infectious diseases by utilizing co-stimulatory receptors[57]. - The CUE-300 framework targets autoimmune diseases by modulating CD4+ T cells, with a collaboration agreement with Merck to advance these programs[61]. - The company has not yet commenced any commercial revenue-generating operations and will need to raise additional capital to fund its growth[13][13]. - The lead product candidate, CUE-101, is undergoing a Phase 1 clinical trial, with additional trials expected to be necessary for FDA approval[148]. Strategic Partnerships and Collaborations - The company has entered into collaboration agreements with Merck and LG Chem for the development of Immuno-STATs targeting autoimmune diseases and oncology, respectively, which include licensing fees, milestone payments, and sales royalties[166][167]. - The Merck Agreement includes a $2.5 million upfront payment and potential milestone payments totaling up to $371 million, along with tiered royalties on sales[78]. - Under the LG Chem Agreement, the company received a $5.0 million upfront payment and may earn up to approximately $400 million in milestone payments, plus tiered royalties on net sales of commercialized products[85]. - Cue Biopharma aims to enhance its core capabilities through investments in protein engineering and translational immunology, potentially including partnerships or acquisitions[18][18]. - The exclusivity provisions in the collaboration agreements with Merck and LG Chem restrict the company's research and development activities, potentially affecting future product development[174][176]. Financial Overview and Funding Needs - As of December 31, 2019, the company had an accumulated deficit of approximately $108.5 million, indicating a history of operating losses and no commercial revenue[142]. - Significant additional funding will be required for research, development, and regulatory compliance, with no assurance of generating commercial revenue[144]. - The company anticipates competition from established pharmaceutical companies with significantly greater resources in the immunotherapy sector[94]. - The company has limited financial and human resources, necessitating a focus on a limited set of product candidates, which may lead to missed opportunities[183][184]. Regulatory Compliance and Challenges - The company must comply with rigorous FDA regulations for biological products, with noncompliance potentially leading to severe penalties[95]. - The FDA regulates the development and marketing of biologic products under the FDCA and PHSA, requiring substantial time and financial resources for compliance[96]. - The process includes preclinical tests, submission of an IND, and approval of a BLA, which must demonstrate safety, efficacy, and compliance with cGMP[98]. - The IND becomes effective 30 days after submission unless the FDA raises concerns, which could delay clinical trials[99]. - The FDA may impose user fees for BLAs, with waivers available for small businesses and orphan drugs[110]. - The FDA reviews BLAs for completeness within 60 days and may refuse to file if deemed incomplete[111]. - The Pediatric Research Equity Act requires data on safety and effectiveness for pediatric populations in BLA submissions[117]. - The FDA has various expedited programs such as Fast Track, Breakthrough Therapy Designation, and priority review to facilitate the development and approval of products for serious diseases[118]. - Compliance with various federal and state healthcare laws is essential, with potential penalties for violations including fines and exclusion from federal healthcare programs[134]. Risks and Uncertainties - The company faces various risks, including potential delays in clinical trials, regulatory approvals, and the need for additional preclinical testing[151]. - Business interruptions, including those related to COVID-19, could adversely impact clinical trials and product development timelines[156]. - The company has limited experience in conducting clinical trials and no history of commercializing biologic products, complicating future viability assessments[149]. - Any adverse events or side effects observed in clinical trials could inhibit regulatory approval or market acceptance of product candidates[157]. - The company faces a high failure rate in clinical trials, with no assurance that preclinical or early trial results will predict later success, potentially impacting financial condition and operations[163]. - The company may incur significant costs and face operational disruptions in establishing new partnerships or collaborations, which could adversely affect business prospects[169][173]. Intellectual Property and Licensing - The company has a total of seven patents and 125 pending foreign patent applications as of December 31, 2019, aimed at protecting its technology[89]. - The Einstein License obligates the company to pay low single-digit royalties on sales of licensed products and includes milestone payments that could total up to $1.85 million per product[67][69]. - The Einstein License requires royalty payments for certain Licensed Products for a minimum of 15 years from the first sale or the duration of market exclusivity, whichever is longer[71]. - The company has met all required Diligence Milestones under the Einstein License, which include annual updates to the R&D plan and initiation of Phase 1, 2, and 3 clinical trials within specified timeframes[74]. Manufacturing and Supply Chain - The company does not have internal manufacturing capabilities and is completely dependent on third-party manufacturers for clinical drug supplies[200]. - The company has a sole source of supply for its lead product candidate, CUE-101, from Catalent Pharma Solutions, LLC, which could disrupt supply if issues arise[206]. - Any significant delay in the supply of product candidates or raw materials could considerably delay clinical trials and regulatory approvals[202]. - The complexity of manufacturing processes for product candidates may lead to delays in clinical trials and regulatory submissions[206]. Management and Operational Risks - The company is highly dependent on key management personnel, and the loss of any principal members could impair the ability to develop new product candidates[189][190]. - The company may not be the first to market with its product candidates, which could negatively impact pricing and demand[188]. - The company relies on third-party CROs for clinical trials, which poses risks if they fail to meet contractual obligations or deadlines[196]. - The regulatory environment surrounding information security and privacy is increasingly demanding, leading to potential significant expenses for compliance[198].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2019 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission file number: 001-38327 Cue Biopharma, Inc. (Exact name of registrant as specified in its charter) Delaware 47-3324577 (State or Other Jurisd ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2019 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission file number: 001-38327 Cue Biopharma, Inc. (Exact name of registrant as specified in its charter) Delaware 47-3324577 (State or Other Jurisdictio ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2019 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission file number: 001-38327 Cue Biopharma, Inc. (Exact name of registrant as specified in its charter) Delaware 47-3324577 (State or Other Jurisdicti ...

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 For the Fiscal Year Ended December 31, 2018 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from __________________ to __________________ Commission file number: 001-38327 Cue Biopharma, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 47-3324 ...

Corporate Presentation BIO CEO & Investor Conference Immune Responses, On Cue™ Nasdaq: CUE February 12, 2019 Copyright © 2019. Cue Biopharma Forward-Looking Statements This presentation has been prepared by Cue Biopharma, Inc. ("we," "us," "our," "Cue" or the "Company") and is made for informational purposes only and does not constitute an offer to sell or a solicitation of an offer to buy securities, nor shall there be any sale of any securities in any state or jurisdiction in which such offer, solicitatio ...