CUE

Cue Biopharma, Inc. (NASDAQ:CUE) reported positive Phase 2 results for CUE-221 on September 20. The randomized, double-blind study enrolled 145 patients in China with moderate to severe chronic spontaneous urticaria, or chronic hives, inadequately controlled by H1 antihistamines. At week 12, complete hive resolution occurred in 54% of patients receiving 4 mg/kg CUE-221 versus 11% receiving placebo. The primary endpoint was met with a 43-percentage-point difference and p<0.005. For investors, the next question is whether relief lasting after treatment stops can give the drug a meaningful advantage over established options. Read Also: Evommune (EVMN) Drops EVO756 for Eczema. Can EVO301 Carry the Pipeline? The results extend beyond hive counts. At the highest dose, 46% achieved complete response on the weekly urticaria activity score, meaning no hives or itching, compared with 11% on placebo. This key secondary endpoint was statistically significant at p<0.05. CUE-221 targets IgE, an antibody involved in allergic reactions. It is designed to neutralize existing IgE while preserving a natural feedback pathway that can suppress new IgE production. That mechanism provides a rationale for investigating prolonged disease control. Relief after treatment ended is the main commercial attraction. At week 28, twelve weeks after the final dose, 60% of the highest-dose group had complete hive resolution, compared with 24% of the omalizumab group. The 36-percentage-point difference came from a post hoc analysis, with reported p<0.05. If replicated in a larger trial, sustained relief could support less frequent treatment and give physicians a reason to consider switching patients. Omalizumab, marketed as Xolair, is approved for this condition with injections every four weeks. Longer intervals between treatments could strengthen the case with patients and payers. Cue Biopharma, Inc. (NASDAQ:CUE) reported no treatment-related serious adverse events or hypersensitivity reactions, including anaphylaxis. Management plans a Phase 2b/3 study intended to support registration. Also read: Pharvaris (PHVS) Reports an 83% HAE Attack-Rate Reduction. Can Oral Convenience Win? The trial tested superiority over placebo, with no planned statistical comparison against omalizumab. Its week-12 efficacy table included 35 patients at the highest CUE-221 dose and 17 on omalizumab. Small groups make estimates sensitive to individual outcomes. The later analysis identifies a potential advantage for a future comparison planned in advance. It does not establish superiority over omalizumab. Both groups had stopped treatment, so the week-28 finding also does not show an advantage over continued omalizumab dosing. Longer follow-up needs to establish how consistently relief persists and when patients require retreatment. Broader evidence also matters. Larger trials across additional populations would help establish whether the benefit holds and detect uncommon adverse events. Lasting symptom control remains different from a permanent cure. Funding matters for Cue Biopharma, Inc. (NASDAQ:CUE). Its August financial update reported $17.4 million in cash and equivalents at June 30, followed by a private placement generating $50 million in gross proceeds. That financing supports development, while the size, duration, and cost of the next trial will determine additional capital needs. The filings available so far reflect positions held before Cue Biopharma, Inc. (NASDAQ:CUE) reported its CUE-221 Phase 2 results. Insider Monkey's database showed 10 hedge funds holding the company at the end of 2Q2026, up from 4 funds three months earlier. Cue Biopharma, Inc. (NASDAQ:CUE) has a positive placebo-controlled result and a potentially valuable durability advantage to test. Our view is that the evidence supports further development. Confirming sustained efficacy, safety, and a practical dosing schedule in a larger study would strengthen the case for challenging established treatment. While we acknowledge the potential of CUE as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: Pan American Silver (PAAS) Updates its Reserve Base. How Much Growth Reflects Better Mines? and Lennar (LEN) Cuts Delivery Forecast. Can Construction Savings Offset Heavy Incentives? This article is originally published at Insider Monkey.

Results support potential for differentiated clinical impact for patients suffering from chronic hives and advancement to Phase 2b/3 registration enabling study Primary endpoint and the key secondary endpoint were met with high statistical significance and CUE-221 demonstrated an overall favorable safety profile Clinically different efficacy profile observed relative to XOLAIR® (omalizumab) highlights potential for a fundamental mechanism-based biological difference Cue Biopharma to host conference call on Monday, September 21, at 8:00 a.m. EDT BOSTON, Sept. 20, 2026 (GLOBE NEWSWIRE) -- Cue Biopharma (Nasdaq: CUE), a clinical-stage biopharmaceutical company targeting transformative therapies for immune-mediated diseases, today announced positive topline results from the Phase 2 clinical trial of CUE-221 (UB-221) conducted in China by Genesis Life Sciences, a related company of Ascendant Health Limited (Ascendant). The trial enrolled 145 participants with moderate to severe chronic spontaneous urticaria (CSU), a disease resulting in chronic hives, that remained inadequately controlled despite treatment with H1 antihistamines. “We are excited to share these positive results which we believe establish CUE-221 as a potential best therapeutic option for patients suffering with chronic spontaneous urticaria,” said Shao-Lee Lin, M.D., Ph.D., President and Chief Executive Officer of Cue Biopharma. “These findings reinforce our enthusiasm for the precision engineered, unique dual mechanism of action of CUE-221, reflecting science that is truly differentiated. Based on the strength of these data, we are working toward the rapid initiation of a Phase 2b/3 study in CSU and continuing to advance a planned Phase 2 study in food allergy. We thank the patients, investigators, and study staff, all of whom made these results possible. We look forward to presenting the complete data set including PK and IgE analyses from this 36-week study at an upcoming scientific meeting.” Phase 2 CSU Study Topline ResultsThe Phase 2 multicenter, randomized, double-blind, placebo and active comparator-controlled study was conducted in China and included a 16-week treatment period with a 20-week follow-up period post-treatment. Patients were randomized in a 2:2:2:1:1 ratio across five treatment groups to either subcutaneously deliver CUE-221 at 4 mg/kg, 2 mg/kg, or 1 mg/kg Q4W, or placebo Q4W, or omalizumab 300 mg Q4W. The primary endpoint was the proportion of patients who achieved HSS7=0 at week 12. A key secondary endpoint assessed complete response, defined as the proportion of patients who achieved UAS7=0 at week 12. The study was designed to test superiority over placebo. Omalizumab was included to enable comparative efficacy without planned statistical testing. The primary endpoint of percentage of patients with HSS7=0 at week 12 was dose-responsive and met at all dose levels. The key secondary endpoint of percentage of patients with UAS7=0 at week 12 was dose responsive and met statistical significance at the 4 mg/kg highest dose level. P-values based on Fisher’s exact test; Clopper-Pearson 95% confidence interval * p The percentage of participants who achieved HSS7=0 further increased beyond the Week 12 primary endpoint, peaking at Week 22 across all CUE-221 dose groups. After a last dose was administered for all groups at Week 16, clinically meaningful benefit was maintained for up to 12 weeks off treatment (through week 28) at the 4 mg/kg dose level. A higher rate of complete resolution of hives was observed for the 4 mg/kg dose group relative to the lower dose groups and placebo, and post hoc analysis at Week 28 demonstrated a statistically significant difference versus omalizumab (delta = 36%), supporting the premise of fundamental difference between CUE-221 and omalizumab with respect to impacts on disease biology. * p Demographics and baseline disease characteristics were generally well balanced across treatment groups. CUE-221 demonstrated a favorable safety profile. There were no treatment-related serious adverse events and no cases of hypersensitivity reactions including anaphylaxis. Injection site reactions (ISR) were infrequent, only one ISR was > grade 1, and none led to study discontinuation. “The results of the Phase 2 CUE-221 study in patients with CSU are particularly notable,” said Dale Umetsu, M.D., Ph.D., Clinical Professor of Medicine and former Chief of the Allergy and Immunology Division, Stanford University, Clinical Professor of Pediatrics, University of California, San Francisco and prior Global Lead for XOLAIR development. “First, the results after 12 weeks of treatment, after three doses, appear to indicate that CUE-221 was better than XOLAIR for CSU at all dose levels tested. Moreover, there was persistent improvement with the 4 mg/kg dose at week 28, which was 12 weeks off treatment, significantly better than that off of standard XOLAIR dosing. Finally, the safety data analyzed so far, show no major safety issues, which is not unexpected from an anti-IgE mAb.” Dr. Umetsu added, “These results suggest that CUE-221, like XOLAIR is designed to prevent IgE from binding to FceR1 but unlike XOLAIR, allows IgE to bind to CD23, may represent a critical advancement over XOLAIR. The results support that the effects of CUE-221 on IgE function could result in substantial efficacy in CSU that persists for several months, even after dosing ends. Since XOLAIR has represented the clear standard for all other CSU therapies, the possibility that CUE-221 may represent a clear improvement above that of XOLAIR is most impressive. That improvement in efficacy may be directly relevant for food allergy, another area where XOLAIR currently prevails as the standard-of-care.“ “I am very pleased to see these outstanding results from the UB-221 Phase 2 CSU trial,” said Tse-Wen Chang, Ph.D., innovator of XOLAIR as well as UB-221 and an international expert in IgE biology. “The UB-221 data provide clear clinical evidence validating the molecule’s design to not only directly neutralize IgE, but also to create a next-generation approach to eliminate the production of new IgE over time. This fundamental difference in biological mechanism that is now clinically evident cannot be reached by giving higher doses or more potent IgE neutralization. Having invented several novel IgE-targeting molecules that ultimately led to the creation of UB-221, I am encouraged by these emerging data and the potential for this approach to offer a meaningfully different path toward a functional treatment for IgE-mediated diseases.” Webcast and Conference CallCue Biopharma will host a conference call and webcast on Monday, September 21 at 8:00 a.m. EDT to present the results. The event will be webcast live and can be accessed via the attached link below. https://edge.media-server.com/mmc/p/mjexxy37 About Dale Umetsu, M.D., Ph.D.Dale Umetsu, M.D., Ph.D., Former chief of the allergy immunology division and tenured professor of pediatrics at Stanford University, and Former Prince al Saud Professor of Pediatrics AT Harvard Medical School. Dr. Umetsu also led global development of XOLAIR and the approval of XOLAIR for CSU and food allergy while at Genentech. Currently, he serves as a clinical professor of pediatrics at the University of California, San Francisco. About Tse-Wen Chang, Ph.D.Tse-Wen Chang, Ph.D., is a Taiwanese immunologist and pioneer in anti-IgE therapy. His early research into the immunoglobulin E (IgE) pathway and antibody-based therapeutics contributed to the development of omalizumab (XOLAIR), which is approved for the treatment of severe allergic asthma and severe chronic spontaneous urticaria. Dr. Chang is a cofounder of Tanox, a biopharmaceutical company focused on anti-IgE therapies for allergic diseases. He previously served as Dean of the College of Life Sciences at National Tsing Hua University in Taiwan and as Distinguished Research Fellow at the Genomics Research Center, Academia Sinica. About Chronic Spontaneous Urticaria CSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch. CSU is typically treated with H1 antihistamines, medicines that target H1 receptors on cells to control symptoms of itch and urticaria. However, the disease remains uncontrolled despite antihistamine treatment in many patients, some of whom are left with limited alternative treatment options. These individuals continue to experience symptoms that can be debilitating and significantly impact their quality of life. About CUE-221CUE-221 (Ascendant-221, UB-221) is a humanized anti-IgE IgG1 monoclonal antibody designed with a precision engineered dual mechanism of action. CUE-221 binds to IgE at sites that are distinct from the binding sites for other anti-IgE monoclonal antibodies. In doing so, it maintains the capacity of total IgE to bind the CD23 receptor at the surface of B cells, resulting in reduced IgE synthesis. Therefore, CUE-221 is a functionally distinct novel anti-IgE antibody designed to not only neutralize free IgE with high potency, but also prevents the synthesis of new IgE which could ultimately result in functional cure if IgE is eradicated. The CUE-221 Phase 2 clinical trial in CSU produced positive topline results and clinical evidence providing initial validation of the clinical potential of a precision engineered anti-IgE dual mechanism of action. The study also demonstrated fundamental biological differences compared to current therapies. Based on these data, we are planning to advance CUE-221 in a Phase 2b/3 study in chronic spontaneous urticaria and in a Phase 2 study in food allergy. CUE-221 (UB-221) was innovated by Dr. Chang Tse Wen, a pioneer in the field of anti-IgE therapy, while serving as a Fellow of Academia Sinica. UB-221 was originally developed by United Biopharma (Holdings) Co., Ltd. (“United Biopharma”) with rights allocated between two of United Biopharma’s related companies, Genesis Life Sciences (“Genesis”) (China, Hong Kong, Macau and Taiwan, where Genesis continues development of the antibody under the name UB-221) and Ascendant Health Limited (“Ascendant”) (rest of world). Under an exclusive license agreement with Ascendant, Cue Biopharma obtained exclusive development, manufacturing, and commercialization rights in Ascendant’s rest of world territories. About Cue BiopharmaCue Biopharma (Nasdaq: CUE) is a clinical stage biopharmaceutical company focused on advancing a portfolio of potentially transformative therapies designed to enable functional cures across immunological disorders. Its lead asset, CUE-221, is a novel anti-IgE antibody with a dual mechanism of action design, moving into Phase 2b/3 development for allergic diseases. In addition, Cue developed the Immuno-STAT® platform which selectively targets disease-specific T cells in vivo without broad immune modulation. Its lead autoimmune candidate, CUE-401, has an investigational new drug application pending in the U.S. for a Phase 1 clinical trial. CUE-401 is designed to regulate inflammation and drive Treg-mediated tolerance. Cue is led by an experienced management team with deep expertise in identifying, acquiring, and advancing promising drug candidates. About Ascendant Health LimitedAscendant is a privately held biotechnology company committed to delivering transformative solutions to patients globally. About Genesis Life SciencesGenesis Life Sciences focuses on the innovative development of monoclonal antibody drugs. It is a biopharmaceutical company with a product line in late-stage clinical trials, specializing in the development of innovative monoclonal antibody drugs applicable to chronic infectious diseases, allergic diseases, and autoimmune diseases. Closely aligned with key national research projects and market demand, the company has introduced highly promising monoclonal antibody products, leveraging internal research capabilities and support from expert teams across various fields to accelerate the product launch and sales process. We care about human health and well-being, focus on unmet patient needs, and drive monoclonal antibody development through innovative thinking, ultimately sharing our results with partners and the public, striving to provide the best treatment for patients.*XOLAIR® is a registered trademark of Novartis AG. Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding the potential of CUE-221, including its potential future benefit to patients, the company’s plans with respect to CUE-221, including the initiation of a Phase 2b/3 clinical trial in CSU and a Phase 2 clinical trial in food allergy and the timing thereof, the company’s expectations regarding the presentation of full clinical data from the Phase 2 CUE-221 trial, the company’s growth, and the company’s business strategies, plans, and prospects. Forward-looking statements, which are based on certain assumptions and describe the company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely,” “promise,” “potential” or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company’s strategies, prospects, financial condition, operations, costs, plans, and objectives are forward-looking statements. Important factors that could cause the company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company’s ability to maintain and establish collaboration, licensing and other arrangements; the company’s limited operating history, limited cash and a history of losses; the company’s ability to achieve profitability; potential setbacks in the company’s research and development efforts for its current and future drug product candidates, including negative or inconclusive results from its preclinical studies or clinical trials or the company’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; potential challenges associated with clinical trials conducted in China and the company’s access to, and acceptability of, the data therefrom; its ability to secure required U.S. Food and Drug Administration (“FDA”) or other governmental approvals for its product candidates and the breadth of any approved indication; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company’s ability to obtain adequate financing to fund its business operations in the future; the company’s ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investor and Media ContactAgnes Lee Chief Investor Relations & Communications [email protected] Marie CampinellSenior Director, Corporate Communications [email protected] Biopharma, Inc.

Announced recent Investigational New Drug (IND) submission to the FDA for CUE-221 in food allergy applications Completed a $50 million private placement (PIPE) to further fund clinical development and the portfolio with significant potential for value-inflection Strengthened the leadership team with the appointments of the Chief Medical Officer and Head of R&D and the Chief Financial Officer Operating results reflected higher expenditures related to the licensing and initiation of the CUE-221 development program, driven by one-time non-cash charges and acquisition-related payments BOSTON, Aug. 14, 2026 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical stage biopharmaceutical company targeting transformative therapies for immune-mediated diseases, today reported second quarter 2026 financial results as well as recent business highlights. “I am pleased with our progress this quarter, advancing our pipeline and strengthening our position for long-term growth,” said Shao-Lee Lin, M.D., Ph.D., president and chief executive officer of Cue Biopharma. “The CUE-221 license agreement augments our portfolio and opportunities and the higher expenditures this quarter reflect expected one-time non-cash items and payments related to the transaction. Combined with our recent CUE-221 IND submission, financing with high-quality investors, and strategic leadership additions, we believe we are well positioned for the next phase of execution. We look forward to anticipated CUE-221 Phase 2 data by the end of this quarter and remain on track to initiate a CUE-401 Phase 1 study by the end of the year.” Business, Financial and Leadership Highlights MilestonesCUE-221 Recently submitted an IND to the FDA in food allergy applications Phase 2 data readout in Chronic Spontaneous Urticaria anticipated by the end of the third quarter of 2026 CUE-401 Company anticipates submitting an IND to the FDA and initiating a Phase 1 clinical study by year-end 2026 Financial and Corporate Completed a private placement for gross proceeds of $50 million primarily to support clinical development, pipeline advancement, and infrastructure growth Leadership Dr. Dominic Borie, Chief Medical Officer and Head of Research and Development, physician-scientist and immunology leader with deep expertise in immunology, joined Cue to help advance key clinical programs in allergic and autoimmune diseases Mr. James M. Ahlers, Chief Financial Officer, a veteran biotechnology finance executive, joined Cue to help strengthen the Company’s financial leadership and the infrastructure needed to support execution of its corporate strategy Second Quarter 2026 Financial Results Second quarter revenue was $7.9 million, compared to $3.0 million in the second quarter of 2025. The increase in 2026 was due to revenue earned from the Boehringer Ingelheim collaboration and license agreement upon achievement of a preclinical milestone, triggered in the second quarter of 2026. Research and development expenses were $49.0 million for the three months ended June 30, 2026, compared to $7.9 million in 2025. The increase primarily consisted of one-time cash payments of approximately $20.0 million, including the upfront payment to Ascendant and transaction-related costs. Additionally, approximately $20.0 million of expense was recognized as the fair value of warrants issued to Ascendant pursuant to the license agreement, with a corresponding credit to shareholders’ equity resulting in no net impact on stockholders’ equity. General and administrative expenses were $46.6 million for the three months ended June 30, 2026, compared to $3.7 million in 2025. The increase was primarily attributable to one-time expenses incurred in connection with the Company's strategic transformation, including approximately $23.0 million related to integration with a newly assembled, complementary management team and transaction-related costs, as well as approximately $19.7 million of non-cash stock-based compensation expense recognized during the quarter. Other income and expense for the three months ended June 30, 2026, primarily comprised a net non-cash loss of $63.1 million related to the license agreement with Ascendant. As a result, a loss on issuance of liability-classified warrants was recognized, partially offset by a gain on the fair value measurement of warrants issued. Net loss for the three months ended June 30, 2026 was $153.1 million, compared to $8.5 million in 2025. The increase was primarily due to one-time non-cash losses accounted for in other income, and one-time expenses related to the license agreement.        As of June 30, 2026, the Company had $17.4 million in cash and cash equivalents after incurring one-time cash outflows related to the license agreement. Subsequent to June 30, 2026, the Company completed a $50 million private placement financing. About Cue BiopharmaCue Biopharma (Nasdaq: CUE) is a clinical stage biopharmaceutical company focused on advancing a portfolio of potentially transformative therapies aimed at enabling functional cures across immunological disorders. Its lead asset, CUE-221, is a novel anti-IgE antibody with a dual mechanism of action, currently in Phase 2 development for allergic diseases. In addition, Cue developed the Immuno-STAT® platform which selectively targets disease-specific T cells in vivo without broad immune modulation. Its lead autoimmune candidate, CUE-401, is advancing towards Phase 1 and was designed to regulate inflammation and drive Treg-mediated tolerance. Cue is led by an experienced management team with deep expertise in identifying, acquiring, and advancing promising drug candidates. Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, the company’s belief regarding the potential benefits and applications of its drug candidates and programs, including the company’s plans to further advance its differentiating Immuno-STAT platform and its lead asset, CUE-221, and its lead autoimmune candidate, CUE-401, including expected timing of clinical trial initiation and data readout: the company’s expectations for its newly appointed executive officers and their contributions to the company; the expected benefits from the company’s license agreement with Ascendant; and expectations regarding the company’s growth, and the company’s business strategies, plans, and prospects. Forward-looking statements, which are based on certain assumptions and describe the company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely,” “promise,” “potential” or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company’s strategies, prospects, financial condition, operations, costs, plans, and objectives are forward-looking statements. Important factors that could cause the company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company’s ability to maintain and establish collaboration, licensing and other arrangements; the company’s limited operating history, limited cash and a history of losses; the company’s ability to obtain adequate financing to fund its business operations; the company’s ability to achieve profitability; potential setbacks in the company’s research and development efforts for its current and future drug product candidates, including negative or inconclusive results from its preclinical studies or clinical trials or the company’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; potential challenges associated with clinical trials conducted in China and the company’s access to, and acceptability of, the data therefrom; its ability to secure required FDA or other governmental approvals for its product candidates and the breadth of any approved indication; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners;  the company's ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments, or otherwise. Investor and Media ContactAgnes Lee Chief Investor Relations & Communications Officer Marie CampinellSenior Director, Corporate Communications [email protected] Biopharma, Inc.

Moves designed to strengthen leadership and financial position, advance portfolio, and leverage expertise in precision immunoengineering Enhanced the company’s portfolio with an exclusive license for, CUE-221, a Phase 2 program targeting allergic disease Hosted virtual R&D day showcasing CUE-401, a bifunctional IL-2 and TGF-B program targeting autoimmune disease Strengthened the company’s balance sheet and ability to fund anticipated cash needs with a $30 million private placement and received a $7.5 million milestone payment under a collaboration and license agreement Appointed Shao-Lee Lin, M.D., Ph.D., as President, CEO and Board Director to lead continued growth and transformation into a clinical-stage company. BOSTON, May 14, 2026 (GLOBE NEWSWIRE) -- Cue Biopharma, Inc. (Nasdaq: CUE), a clinical stage therapeutics company focused on developing transformative therapies targeting functional cures for immunological disorders, today reported first quarter 2026 financial results and highlighted recent corporate progress and upcoming milestones. “We are excited to advance our enhanced portfolio targeting the potential for functional cures for allergic and autoimmune diseases with high unmet need. Our newly expanded pipeline reflects our strengthened strategy and position in anticipation of significant value-driving milestones in the second half of 2026,” said Shao-Lee Lin, M.D., Ph.D., president and chief executive officer of Cue Biopharma. “With the recent financing, we believe our current cash runway will be sufficient to support the execution of our expected clinical milestones for CUE-221 and CUE-401. As a team, we look forward to leveraging our strength in precision immunoengineering to advance these assets and create long-term shareholder value to provide transformative therapies for patients.” Business Highlights Pipeline and Strategy Enhanced pipeline with CUE-221 (formerly known as Ascendant-221), a late-stage novel clinical anti-IgE asset with a dual-mechanism through an exclusive license from Ascendant Health Sciences Ltd (Ascendant Health). Hosted a virtual R&D Day focused on CUE-401, a potential first-in-class bifunctional cytokine designed to induce tolerance in autoimmune and inflammatory diseases. Financial and Corporate Completed a private placement of pre-funded warrants and accompanying common warrants for gross proceeds of approximately $30 million, before placement agent fees and offering expenses, and aggregate net proceeds of approximately $28 million, to support the company’s clinical pipeline, including advancing CUE-221. Received a $7.5 million preclinical milestone payment under the Boehringer Ingelheim collaboration and license agreement for the selection and approval of Boehringer Ingelheim’s first compound for lead optimization. Leadership Appointed a new President and CEO, Shao-Lee Lin, M.D., Ph.D., a biopharmaceutical executive and physician scientist with 25 years of experience in core immunology experience who has helped build multi-billion-dollar portfolios, built strong teams, and taken a company from inception to IPO. Additional executives join Cue's legacy team in forming a growing complement of clinical and preclinical expertise across the company. Upcoming Milestones CUE-221: Cue expects to submit an Investigational New Drug (IND) amendment to the U.S. Food and Drug Administration (FDA) to expand development into food allergy in the second half of 2026. Results from Ascendant Health’s ongoing China Phase 2 placebo-and active-controlled dose-ranging study in Chronic Spontaneous Urticaria are expected in the second half of 2026. Plan to initiate global, Phase 2b trial in food allergy pending Cue’s review of results from Ascendant Health’s ongoing the China Phase 2 CSU study results. CUE-401: Cue expects to submit an IND to the FDA in the second half of 2026. Phase 1 first-in-human study expected to be initiated by year-end 2026. First Quarter 2026 Financial Results First quarter revenue was $5.7 million compared to $0.4 million in the first quarter of 2025. The revenue earned during the three months ended March 31, 2026 was related to the Boehringer Ingelheim collaboration and license agreement. The revenue earned during the three months ended March 31, 2025 was related to the agreement with Ono Pharmaceutical, which was terminated in March 2025. Research and development expenses were $6.9 million for the three months ended March 31, 2026 compared to $8.5 million in 2025. The decrease was primarily due to lower clinical trial costs for the company’s CUE-100 series, as well as decreases in expenditure for total employee compensation due to attrition. General and administrative expenses were $4.2 million for both the three months ended March 31, 2026 and 2025. Net loss for the three months ended March 31, 2026 was $5.2 million compared to $12.3 million in 2025. As of March 31, 2026, the Company had $16.4 million in cash and cash equivalents. Subsequent to March 31, 2026, the Company has completed a $30 million private placement financing and also received a milestone payment of $7.5 million from Boehringer Ingelheim. ____________________________________________________ (*) The number of shares and per share amounts have been retroactively restated to reflect the one-for-thirty (1-for-30) reverse stock split, which was effective on April 23, 2026. About Cue Biopharma Cue Biopharma (Nasdaq: CUE) is a clinical stage therapeutics company focused on advancing a portfolio of potentially transformative therapies aimed at enabling functional cures across immunological disorders. Its lead asset is a novel anti-IgE antibody with a dual-mechanism of action, currently in Phase 2 development for allergic diseases. In addition, Cue developed the Immuno-STAT® platform which selectively targets disease-specific T cells in vivo without broad immune modulation. Its lead autoimmune candidate, CUE-401, is advancing towards Phase 1 and was designed to regulate inflammation and drive Treg-mediated tolerance. Cue is led by an experienced management team with deep expertise in identifying, acquiring, and advancing promising drug candidates. For more information please visit www.cuebiopharma.com and follow us on X and LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the company’s belief regarding the potential benefits and applications of its drug candidates and programs, including the company’s plans to further advance its assets, including CUE-401 and CUE-221, including anticipated timing for regulatory submissions and initiation of clinical trials; the anticipated timeline for reporting data from Ascendant Health’s China Phase 2 study for CUE-221; the potential therapeutic benefits of the company’s assets, including CUE-401 and CUE-221; and the sufficiency of the company’s current cash and cash equivalents to fund its anticipated clinical milestones for CUE-401 and CUE-221 for the remainder of 2026. Forward-looking statements, which are based on certain assumptions and describe the company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely,” “promise” or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company’s strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company’s ability to maintain and establish collaboration, licensing and other arrangements; the company’s limited operating history, limited cash and a history of losses; the company’s ability to obtain adequate financing to fund its business operations in the near term and successfully remediate its current “going concern” determination that it does not have sufficient capital on hand to continue operations beyond the next twelve months; the company’s ability to achieve profitability; potential setbacks in the company’s research and development efforts for its current and future drug product candidates, including negative or inconclusive results from its preclinical studies or clinical trials or the company’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; potential challenges associated with clinical trials conducted in China and the company’s access to, and acceptability of, the data therefrom; its ability to secure required FDA or other governmental approvals for its product candidates and the breadth of any approved indication; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company’s ability to obtain adequate financing to fund its business operations in the future and ability to continue as a going concern; the company’s ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investor and Media Contact Agnes Lee Chief Officer of Public and Investor Relations Marie Campinell Senior Director, Corporate Communications [email protected] Cue Biopharma, Inc.

Advanced research and development of CUE-401 for IND (Investigational New Drug) readiness – CUE-401 is the Company’s lead asset for the treatment of autoimmune and inflammatory diseases Appointed industry veteran Lucinda Warren as Chief Financial and Business Officer Raised net proceeds of $10.2M through an underwritten public offering Announced strategic collaboration and license agreement with ImmunoScape to develop breakthrough cell therapy approach for solid tumors – Entitled to receive upfront payments totaling $15M BOSTON, March 16, 2026 (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 and inflammatory diseases, today reported fourth quarter and full year 2025 financial results. “During the fourth quarter and throughout the full year 2025, the Company successfully met its strategic development goals and objectives that demonstrated significant progress towards establishing potential first-in-class and best-in-class assets for patients suffering with autoimmune diseases,” said Usman Azam, M.D., president and chief executive officer of Cue Biopharma. “With these strategic deliverables and continued progress to date, we believe we are well positioned to further advance our differentiating Immuno-STAT® platform and lead autoimmune asset, CUE-401, toward the clinic to address major unmet needs in autoimmune disease treatment.” Business Highlights Advanced research and development of CUE-401 for IND (Investigational New Drug) readiness Conducted toxicology and pharmacology studies and announced preclinical safety and tolerability data In two non-GLP studies, CUE-401 was well tolerated with no adverse events observed Proof-of concept studies reinforce promising preclinical profile and therapeutic potential of CUE-401 Presented in vivo and in vitro data that demonstrate the therapeutic potential of CUE-401 to restore immune balance for the treatment of autoimmune and inflammatory diseases at the World Immune Regulation Meeting (WIRM) held March 11-14, 2026 Announced strategic collaboration and license agreement with ImmunoScape to develop breakthrough cell therapy approach for solid tumors Entitled to upfront payments totaling $15 million. Of these payments, received $9.5 million, net of withholding taxes in the fourth quarter of 2025, and entitled to receive an additional $5 million in November 2026 Received a 40% equity stake in ImmunoScape, and the Company is eligible for high-single digit royalties Company plans to announce Virtual R&D Day event highlighting CUE-401, the company’s lead autoimmune asset, within the next couple of weeks. CUE-401 is designed to act mechanistically both as a regulator of proinflammatory mechanisms and as a master switch for regulatory T cell (Treg) differentiation to induce tolerance. Fourth Quarter 2025 Financial Results The Company reported collaboration revenue of $21.9 million and $1.6 million for the three months ended December 31, 2025 and 2024, respectively. The increase was primarily due to revenue recognized from the collaboration and license agreement with ImmunoScape in the fourth quarter of 2025. Research and development expenses were $16.5 million and $7.2 million for the three months ended December 31, 2025 and 2024, respectively. The increase was primarily due to an increase in drug substance manufacturing and lab costs for CUE-401, an increase from one-time acquired in-process research and development costs in connection with our collaboration and license agreement with ImmunoScape, and an increase in license fees payable to Einstein in connection with the collaboration and license agreement with ImmunoScape. These increases were partially offset by a decrease in employee compensation, which includes stock-based compensation, due to a reduction in headcount, as well as a decrease in clinical trial costs as a result of licensing molecules from the CUE-100 series to ImmunoScape. General and administrative expenses were $3.5 million and $4.0 million for the three months ended December 31, 2025 and 2024, respectively. The decrease was primarily due to a decrease in employee compensation, which includes stock-based compensation, due to a reduction in headcount, partially offset by an increase in severance paid to our former chief executive officer, as well as an increase in professional fees related to the review, negotiation, and preparation of the collaboration and license agreement with ImmunoScape. Full Year 2025 Financial Results The Company reported collaboration revenue of $27.5 million and $9.3 million for the years ended December 31, 2025 and 2024, respectively. The increase was primarily due to revenue earned from our collaboration and license agreement entered into with ImmunoScape in the fourth quarter of 2025. Research and development expenses were $37.7 million and $36.3 million for the years ended December 31, 2025 and 2024, respectively. The increase was primarily due to one-time acquired in-process research and development costs in connection with our collaboration and license agreement with ImmunoScape, an increase in drug substance manufacturing and lab costs for CUE-401, and an increase in license fees payable to Einstein in connection with the collaboration and license agreement with ImmunoScape. These increases were partially offset by a decrease in employee compensation, which includes stock-based compensation, due to a reduction in headcount, as well as a decrease in clinical trial costs as a result of licensing molecules from the CUE-100 series to ImmunoScape. General and administrative expenses were $16.2 million and $14.6 million for the years ended December 31, 2025 and 2024, respectively. The increase was primarily due to an increase in professional fees, which included fees incurred for the review, negotiation, and preparation of our 2025 collaboration and license agreements and an increase in severance paid to our former chief executive officer, partially offset by a decrease in employee compensation, which includes stock-based compensation, due to a reduction in headcount. As of December 31, 2025, the Company had $27.1 million in cash and cash equivalents. About Cue Biopharma Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT® (Selective Targeting and Alteration of T cells) and biologics are designed to harness the curative potential of the body’s intrinsic immune system without the adverse effects of broad systemic immune modulation. CUE-401, the company’s lead autoimmune asset, is designed to act mechanistically both as a regulator of proinflammatory mechanisms, and as a master switch for regulatory T cell (Treg) differentiation to induce tolerance. It is a highly innovative, tolerogenic bifunctional molecule combining a TGF-beta breathing-mask moiety with Cue Biopharma’s clinically validated interleukin 2 (IL-2) mutein in a single injectable biologic. Headquartered in Boston, Massachusetts, we are led by an experienced management team with deep expertise in immunology and protein engineering as well as the design and clinical development of protein biologics. For more information please visit www.cuebiopharma.com and follow us on X and LinkedIn. Cautionary Note Regarding Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the company’s belief regarding the potential benefits and applications of its drug candidates and programs, including the company’s plans to further advance its differentiating Immuno-STAT® platform and lead autoimmune asset, CUE-401, toward the clinic to address a major unmet need in autoimmune disease treatment; the company’s belief that CUE-401 has the therapeutic potential to restore immune balance for the treatment of autoimmune and inflammatory diseases; the company’s business strategies, plans and prospects; the potential benefits of the therapeutic approach to be developed pursuant to the collaboration and license agreement with ImmunoScape and receipt of upfront payments pursuant to such agreement; and the company’s plans to host a virtual R&D day event and the timing thereof. Forward-looking statements, which are based on certain assumptions and describe the company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely,” “promise” or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company’s strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company’s ability to maintain its collaboration with ImmunoScape; the company’s limited operating history, limited cash and a history of losses; the company’s ability to obtain adequate financing to fund its business operations in the near term and successfully remediate its current “going concern” determination that it does not have sufficient capital on hand to continue operations beyond the next twelve months; the company’s ability to achieve profitability; potential setbacks in the company’s research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or the company’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; its ability to secure required U.S. Food and Drug Administration (FDA) or other governmental approvals for its product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including possible effects on the company’s operations and clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company’s ability to obtain adequate financing to fund its business operations in the future and ability to continue as a going concern; the company’s ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investor Contact Marie Campinell Senior Director, Corporate Communications Cue Biopharma, Inc. [email protected] Media Contact Jonathan Pappas LifeSci Communications [email protected]

Announced strategic collaboration and license agreement with ImmunoScape to develop breakthrough cell therapy approach for solid tumors – Company is entitled to receive upfront payments totaling $15M Announced strategic transition in leadership to further enable next stage of growth with disruptive autoimmune therapeutic candidates, most notably CUE-401, the Company’s lead autoimmune asset BOSTON, Nov. 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 third quarter 2025. “During the third quarter of 2025 and early in the fourth quarter, the Company made tremendous progress from having successfully implemented a plan of optionality and laying the necessary groundwork for future growth,” said Usman Azam, M.D., president and chief executive officer of Cue Biopharma. “I am deeply proud of the Cue team and believe we are strategically positioned to further advance our differentiating Immuno-STAT® platform and lead autoimmune asset, CUE-401, toward the clinic to address a major unmet need in autoimmune disease treatment.” Business Highlights Announced strategic transition in leadership to further enable next stage of growth with disruptive autoimmune therapeutic candidates, most notably CUE-401, the Company’s lead autoimmune asset Usman Azam, M.D., appointed President and Chief Executive Officer, effective as of September 29 CUE-401 is uniquely engineered and designed as a tolerogenic bifunctional molecule harnessing the power of transforming growth factor beta (TGF-β) and interleukin 2 (IL-2) to re-establish immune tolerance and balance Announced strategic collaboration and license agreement with ImmunoScape to develop breakthrough cell therapy approach for solid tumors Upfront total payment of $15 million, $10 million in Q4 2025 and $5 million in November of 2026, as well as a 40% equity stake in ImmunoScape Exclusive collaboration and license agreement focuses on advancing novel, T cell therapy “Seed-and-Boost” approach exploiting the mechanism of the CUE-100 series of Immuno-STATs® Reported new complete response and confirmed 50% overall response rate (ORR) in ongoing Phase 1 trial of CUE-101 and pembrolizumab (KEYTRUDA®) in recurrent/metastatic HPV+ head and neck cancer. New data observed included 12-month overall survival of 88% and median overall survival (mOS) of 32.7 months Third Quarter 2025 Financial Results The Company reported collaboration revenue of $2.1 million and $3.3 million for the three months ended September 30, 2025 and 2024, respectively. The decrease was due to the timing of revenue earned from the Company’s collaboration and license agreement with Boehringer Ingelheim International GmbH (BI) in 2025 compared to the timing of revenue earned from the Company’s Ono Collaboration and Option Agreement in 2024. Research and development expenses were $4.8 million and $9.4 million for the three months ended September 30, 2025 and 2024, respectively. The decrease was primarily due to decreases in clinical trial costs for the Company’s CUE-100 series, as well as decreases in employee compensation. General and administrative expenses were $4.9 million and $2.9 million for the three months ended September 30, 2025 and 2024, respectively. The increase was primarily due to a one-time employee severance accrual in September of 2025, as well as an increase in professional fees. About Cue Biopharma Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT® (Selective Targeting and Alteration of T cells), and biologics are designed to harness the curative potential of the body’s intrinsic immune system without the adverse effects of broad systemic immune modulation. CUE-401, the company’s lead autoimmune asset, is designed to act mechanistically as a master switch for regulatory T cell (Treg) differentiation and tolerance induction. It is a highly innovative bifunctional molecule combining a TGF-beta breathing-mask moiety with Cue Biopharma’s clinically validated interleukin (IL-2) mutein in a single injectable biologic. Headquartered in Boston, Massachusetts, we are led by an experienced management team with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics. For more information please visit www.cuebiopharma.com and follow us on X and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the company’s belief regarding the potential benefits and applications of its drug candidates and programs, including the company’s plans to further advance its differentiating Immuno-STAT® platform and lead autoimmune asset, CUE-401, toward the clinic to address a major unmet need in autoimmune disease treatment; the company’s business strategies, plans and prospects; and the potential benefits of the therapeutic approach to be developed pursuant to the collaboration and license agreement with ImmunoScape. Forward-looking statements, which are based on certain assumptions and describe the company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely,” “promise” or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company’s strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company’s ability to maintain its collaboration with ImmunoScape; the company’s limited operating history, limited cash and a history of losses; the company’s ability to obtain adequate financing to fund its business operations in the near term and successfully remediate its current “going concern” determination that it does not have sufficient capital on hand to continue operations beyond the next twelve months; the company’s ability to achieve profitability; potential setbacks in the company’s research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or the company’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; its ability to secure required U.S. Food and Drug Administration (“FDA”) or other governmental approvals for its product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including possible effects on the company’s operations and clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company’s ability to obtain adequate financing to fund its business operations in the future and ability to continue as a going concern; the company’s ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investor Contact Marie Campinell Senior Director, Corporate Communications Cue Biopharma, Inc. [email protected] Media Contact Jonathan Pappas LifeSci Communications [email protected]

Received FDA feedback on Pre-IND Briefing Document reinforcing Company’s intention to advance investigational new drug (IND) submission for CUE-401 to address unmet need in the treatment of autoimmune disease. Announced strategic research collaboration and license agreement with Boehringer Ingelheim to develop and commercialize CUE-501, a differentiated B cell depletion therapy for autoimmune and inflammatory diseases. Upfront payment of $12 million and ~$345 million in potential milestone payments Raised approximately $20 million through a public offering. 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. “We made significant progress during the second quarter with highly encouraging clinical data from our ongoing Phase 1b clinical trial, supporting our belief that CUE-101, representative of the CUE-100 series, has the potential to establish a new standard of care for HPV+ HNSCC patients,” said Daniel Passeri, chief executive officer of Cue Biopharma. “These maturing data, together with the continued advancements of our lead autoimmune programs, reinforces our commitment to provide patients with more effective and well tolerated therapies to treat serious disease.” Business Highlights Received 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 strategic research collaboration and license agreement with Boehringer Ingelheim to develop and commercialize CUE-501, a differentiated B cell depletion therapy for autoimmune and inflammatory diseases. Upfront payment of $12 million and ~$345 million in potential milestone payments Raised approximately $20 million through a public offering. Hosted virtual investor event, Mobilizing the Immune System: Cue Biopharma’s Novel Biologics Portfolio, featuring key opinion leaders, Richard DiPaolo, PhD, and Andrew Cope, MD PhD. Poster presentation delivered by Dana-Farber Cancer Institute at the American Society of Gene & Cell Therapy Annual Meeting presented proof-of-concept data on CUE-101 and its potential to control CAR-T cell expansion and persistence in vivo. Reported new complete response and confirmed 50% overall response rate (ORR) in ongoing Phase 1 trial of CUE-101 and pembrolizumab (KEYTRUDA®) in recurrent/metastatic HPV+ head and neck cancer. Data observed included 12-month overall survival of 88% and median overall survival (mOS) of 32 months. Second Quarter 2025 Financial Results The Company reported collaboration revenue of $3.0 million and $2.7 million for the three months ended June 30, 2025 and 2024, respectively. The increase was due to the timing of revenue earned from the collaboration and license agreement with Boehringer Ingelheim International GmbH (BI). Research and development expenses were $7.9 million and $9.5 million for the three months ended June 30, 2025 and 2024, respectively. The decrease was primarily due to decreases in clinical trials costs and employee compensation. General and administrative expenses were $3.7 million and $3.5 million for the three months ended June 30, 2025 and 2024, respectively. The increase was primarily due to an increase in professional fees. About Cue Biopharma Cue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT® (Selective Targeting and Alteration of T cells), and biologics are designed to harness the curative potential of the body’s intrinsic immune system without the adverse effects of broad systemic immune modulation. Headquartered in Boston, Massachusetts, we are led by an experienced management team with deep expertise in immunology and immuno-oncology as well as the design and clinical development of protein biologics. For more information please visit www.cuebiopharma.com and follow us on X and LinkedIn. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the company’s belief regarding the potential benefits and applications of its drug candidates and programs, including CUE-101’s potential to control CAR-T cell expansion and persistence in vivo and that CUE-101 has the potential to establish a new standard of care for HPV+ HNSCC patients; the company’s plans to submit an IND for CUE-401; the company’s business strategies, plans and prospects; and the company’s potential receipt of future milestone-based payments. Forward-looking statements, which are based on certain assumptions and describe the company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely,” “promise” or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company’s strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company’s limited operating history, limited cash and a history of losses; the company’s ability to obtain adequate financing to fund its business operations in the near term and successfully remediate its current “going concern” determination that it does not have sufficient capital on hand to continue operations beyond the next twelve months; the company’s ability to achieve profitability; potential setbacks in the company’s research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or the company’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; its ability to secure required U.S. Food and Drug Administration (“FDA”) or other governmental approvals for its product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including possible effects on the company’s operations and clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the company’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the company’s ability to obtain adequate financing to fund its business operations in the future and ability to continue as a going concern; the company’s ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operations sections of the company’s most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the company in this press release is based only on information currently available to the company and speaks only as of the date on which it is made. The company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investor Contact Marie Campinell Senior Director, Corporate Communications Cue Biopharma, Inc. [email protected] Media Contact Jonathan Pappas LifeSci Communications [email protected]

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 Raised gross proceeds of ~$20 million in follow-on capital raise Successfully regained worldwide rights for lead autoimmune program, CUE-401, with potential to become a new standard of care for autoimmune and inflammatory diseases Virtual Event planned for May 15, 2025 at 11 AM ET, featuring two prominent Key Opinion Leaders in the field of Immunology BOSTON, May 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 reported first quarter 2025 financial results. “We made notable and encouraging progress during the first quarter of 2025 and believe we are well positioned to further our corporate objectives,” said Daniel Passeri, chief executive officer of Cue Biopharma. “We believe the strategic collaboration with Boehringer Ingelheim for CUE-501 combined with our capital raise, places us in a position of strength to advance CUE-401 toward the clinic while exploring additional portfolio optimization and partnering opportunities.” Upcoming EventNovel Biologics Portfolio Virtual Event planned for May 15, 2025 at 11 AM ET: Cue Biopharma’s virtual event will feature two key opinion leaders (KOLs): Richard DiPaolo, PhD (Saint Louis University) and Andrew Cope, MD, PhD (Centre for Rheumatic Diseases, King's College London). The event will highlight new preclinical data for CUE-401, as well as provide an overview of the CUE-500 program and include key updates on the CUE-100 series clinical oncology programs. The live and archived virtual event will also be available in the News + Publications section of the Company’s website. The webcast will be archived for 30 days. First Quarter 2025 Financial Results The Company reported revenue of $0.4 million and $1.7 million for the three months ended March 31, 2025 and 2024, respectively, related to the agreement with Ono Pharmaceutical, which was terminated in March 2025. Research and development expenses were $8.5 million and $10.2 million for the three months ended March 31, 2025 and 2024, respectively. The decrease was primarily due to decreases in clinical trial costs, and employee compensation, which includes stock-based compensation. General and administrative expenses were $4.2 million for both the three months ended March 31, 2025 and 2024. As of March 31, 2025, the Company had $13.1 million in cash and cash equivalents. Subsequently, the Company received approximately $18 million in net proceeds in April 2025 from an underwritten public offering, and the Company received an upfront fee of $12 million pursuant to the Collaboration and License Agreement with Boehringer Ingelheim announced on April 14, 2025. About Cue BiopharmaCue Biopharma, a clinical-stage biopharmaceutical company, is developing a novel class of injectable biologics to selectively engage and modulate disease-specific T cells directly within the patient’s body. The company’s proprietary platform, Immuno-STAT™ (Selective Targeting and Alteration of T cells) and biologics are designed to harness the curative potential of the body’s intrinsic immune system through the selective modulation of disease-specific T cells without the adverse effects of broad systemic immune modulation. Headquartered in Boston, Massachusetts, we are led by an experienced management team with deep expertise in immunology and protein engineering as well as the design and clinical development of protein biologics. For more information please visit www.cuebiopharma.com and follow us on X and LinkedIn. Cautionary Note Regarding Forward-Looking StatementsThis press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include, but are not limited to, those regarding: the Company’s belief that CUE-401 has potential to transform treatment across a broad spectrum of autoimmune and inflammatory diseases; the potential therapeutic benefits of CUE-501 and the CUE-500 series; the Company’s ability to advance its Immuno-STAT™ platform; and the Company’s business strategies, plans and prospects, including the Company’s plans to advance CUE-401 toward the clinic and explore additional portfolio optimization and partnering opportunities. Forward-looking statements, which are based on certain assumptions and describe the Company’s future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “would,” “could,” “seek,” “intend,” “plan,” “goal,” “project,” “estimate,” “anticipate,” “strategy,” “future,” “likely” or other comparable terms, although not all forward-looking statements contain these identifying words. All statements other than statements of historical facts included in this press release regarding the company’s strategies, prospects, financial condition, operations, costs, plans and objectives are forward-looking statements. Important factors that could cause the Company’s actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others, the company’s limited operating history, limited cash and a history of losses; the Company’s ability to obtain adequate financing to fund its business operations in the near term and successfully remediate its current “going concern” determination that it does not have sufficient capital on hand to continue operations beyond the next twelve months; the Company’s ability to achieve profitability; potential setbacks in the Company’s research and development efforts including negative or inconclusive results from its preclinical studies or clinical trials or the Company’s ability to replicate in later clinical trials positive results found in preclinical studies and early-stage clinical trials of its product candidates; serious and unexpected drug-related side effects or other safety issues experienced by participants in clinical trials; the Company’s ability to secure required U.S. Food and Drug Administration (“FDA”) or other governmental approvals for its product candidates and the breadth of any approved indication; adverse effects caused by public health pandemics, including possible effects on the Company’s operations and clinical trials; delays and changes in regulatory requirements, policy and guidelines including potential delays in submitting required regulatory applications to the FDA; the Company’s reliance on licensors, collaborators, contract research organizations, suppliers and other business partners; the Company’s ability to maintain and enforce necessary patent and other intellectual property protection; competitive factors; general economic and market conditions and the other risks and uncertainties described in the Risk Factors and Management's Discussion and Analysis of Financial Condition and Results of Operations sections of the Company’s most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Report(s) on Form 10-Q. Any forward-looking statement made by the Company in this press release is based only on information currently available to the Company and speaks only as of the date on which it is made. The Company undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. Investor Contact Marie Campinell Senior Director, Corporate CommunicationsCue Biopharma, [email protected] Media ContactJonathan PappasLifeSci [email protected]

Opus Genetics, Inc. (IRD) is expected to deliver a year-over-year decline in earnings on higher revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook gives a good sense of the company's earnings picture, but how the actual results compare to these estimates is a powerful factor that could impact its near-term stock price. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This company is expected to post quarterly loss of $0.34 per share in its upcoming report, which represents a year-over-year change of -17.2%. Revenues are expected to be $2.8 million, up 63.7% from the year-ago quarter. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Opus Genetics, Inc.The Most Accurate Estimate is the same as the Zacks Consensus Estimate, suggesting that there are no recent analyst views which differ from what have been considered to derive the consensus estimate. This has resulted in an Earnings ESP of 0%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination makes it difficult to conclusively predict that Opus Genetics, Inc. Will beat the consensus EPS estimate. While calculating estimates for a company's future earnings, analysts often consider to what extent it has been able to match past consensus estimates. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Opus Genetics, Inc. Would post a loss of $0.34 per share when it actually produced a loss of $1.27, delivering a surprise of -273.53%. Over the last four quarters, the company has beaten consensus EPS estimates just once. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Opus Genetics, Inc. Doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Another stock from the Zacks Medical - Biomedical and Genetics industry, Cue Biopharma, Inc. (CUE), is soon expected to post loss of $0.14 per share for the quarter ended March 2025. This estimate indicates a year-over-year change of +44%. Revenues for the quarter are expected to be $2 million, up 16.3% from the year-ago quarter. Over the last 30 days, the consensus EPS estimate for Cue Biopharma has remained unchanged. Nevertheless, the company now has an Earnings ESP of -7.14%, reflecting a lower Most Accurate Estimate. When combined with a Zacks Rank of #2 (Buy), this Earnings ESP makes it difficult to conclusively predict that Cue Biopharma will beat the consensus EPS estimate. The company beat consensus EPS estimates in each of the trailing four quarters. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Opus Genetics, Inc. (IRD) : Free Stock Analysis Report Cue Biopharma, Inc. (CUE) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

The market expects Cue Biopharma, Inc. (CUE) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended March 2025. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The earnings report might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While the sustainability of the immediate price change and future earnings expectations will mostly depend on management's discussion of business conditions on the earnings call, it's worth handicapping the probability of a positive EPS surprise. This company is expected to post quarterly loss of $0.14 per share in its upcoming report, which represents a year-over-year change of +44%. Revenues are expected to be $2 million, up 16.3% from the year-ago quarter. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that an aggregate change may not always reflect the direction of estimate revisions by each of the covering analysts. Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Cue Biopharma, the Most Accurate Estimate is lower than the Zacks Consensus Estimate, suggesting that analysts have recently become bearish on the company's earnings prospects. This has resulted in an Earnings ESP of -7.14%. On the other hand, the stock currently carries a Zacks Rank of #2. So, this combination makes it difficult to conclusively predict that Cue Biopharma will beat the consensus EPS estimate. Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Cue Biopharma would post a loss of $0.16 per share when it actually produced a loss of $0.13, delivering a surprise of +18.75%. Over the last four quarters, the company has beaten consensus EPS estimates four times. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Cue Biopharma doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Among the stocks in the Zacks Medical - Biomedical and Genetics industry, Harmony Biosciences Holdings, Inc. (HRMY) is soon expected to post earnings of $0.59 per share for the quarter ended March 2025. This estimate indicates a year-over-year change of -11.9%. This quarter's revenue is expected to be $183.52 million, up 18.7% from the year-ago quarter. The consensus EPS estimate for Harmony Biosciences has been revised 1% higher over the last 30 days to the current level. However, a higher Most Accurate Estimate has resulted in an Earnings ESP of 33.09%. This Earnings ESP, combined with its Zacks Rank #3 (Hold), suggests that Harmony Biosciences will most likely beat the consensus EPS estimate. The company beat consensus EPS estimates in each of the trailing four quarters. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Cue Biopharma, Inc. (CUE) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research