Board Change • Jun 04
Less than half of directors are independent There are 5 new directors who have joined the board in the last 3 years. Of these new board members, 1 was an independent director. The company's board is composed of: 5 new directors. 5 experienced directors. 1 highly experienced director. 2 independent directors (3 non-independent directors). Co-Founder and Chairman of Scientific & Clinical Advisory Board Steven Almo is the most experienced director on the board, commencing their role in 2015. Independent Chairman of the Board Pasha Sarraf was the last independent director to join the board, commencing their role in 2025. The following issues are considered to be risks according to the Simply Wall St Risk Model: Minority of independent directors. Lack of board continuity. Lack of experienced directors. Announcement • Jun 03
Cue Biopharma, Inc. Announces Board Changes Cue Biopharma, Inc. announced the transition of its board as the Company continued its strategic growth and transformation to support late clinical stage capabilities and activities. Effective May 29, 2026, four independent directors, Jill Broadfoot, Peter Kiener, Frank Morich, and Patrick Verheyen, resigned from the board. The company simultaneously announced the appointment of Daniel Camardo and Viola Meehan to the board. Daniel Camardo has over 30 years of industry experience and currently serves as President of Immedica Pharma North America, a subsidiary of Immedica Pharma AB, a Swedish biopharma focused on commercializing rare disease and specialty medicines. Before his role at Immedica Pharma, Mr. Camardo served as CEO at Athersys, a publicly traded clinical stage cell therapy company. He earlier served in senior executive roles at companies including Astellas Pharma, Inc, Clarus Therapeutics, Inc, and Horizon Therapeutics, where he was Executive Vice President and President, U.S. before Horizon Therapeutics was acquired by Amgen in 2023. Mr. Camardo holds a bachelor’s degree in economics from the University of Rochester and a Master of Business Administration from Northwestern University. Viola M. Meehan has over 30 years of experience comprising both board membership and finance roles. She currently serves as independent director of the privately held, Chicago-based Federal Savings Bank, and has held impactful committee chair roles at various institutions. Ms. Meehan’s experience in biopharma spans both large corporate and startup organizations. She previously served as Chief Financial Officer at Vanqua Bio, a startup focused on neurodegenerative diseases. Earlier in her career, she was Vice President, R&D Finance and Operations at Abbvie, Inc. and Controller, U.S. Commercial Products at Abbott Laboratories. She was previously a staff auditor at Coopers & Lybrand, now PricewaterhouseCoopers (PwC). Ms. Meehan holds a bachelor’s degree in economics from the University of Pennsylvania’s Wharton School and a Master of Business Administration in finance from the University of Chicago. Reported Earnings • May 20
First quarter 2026 earnings released: US$1.08 loss per share (vs US$4.95 loss in 1Q 2025) First quarter 2026 results: US$1.08 loss per share (improved from US$4.95 loss in 1Q 2025). Revenue: US$5.69m (up US$5.27m from 1Q 2025). Net loss: US$5.18m (loss narrowed 58% from 1Q 2025). Revenue is expected to decline by 115% p.a. on average during the next 2 years, while revenues in the Biotechs industry in Europe are expected to grow by 14%. Over the last 3 years on average, earnings per share has increased by 48% per year but the company’s share price has fallen by 45% per year, which means it is significantly lagging earnings. Announcement • May 15
Cue Biopharma, Inc. announced that it has received $29.999992 million in funding On May 14, 2026, Cue Biopharma, Inc. closed the transaction. The net proceeds after deducting placement agent fees and offering expenses is $28,000,000. Announcement • May 02
Cue Biopharma, Inc. announced that it expects to receive $29.999992 million in funding Cue Biopharma, Inc entered into a securities purchase agreement with certain accredited investors for a private placement to issue 2,727,272 pre-funded warrant at an issue price of $11 for the proceeds of $29,999,992 along with common stock warrants on April 30, 2026. The exercise price of the Pre-Funded Warrants is $0.001 per share. The exercise price of the Warrants is $11.00 per share. The Pre-Funded Warrants are exercisable at any time following receipt of approval by the Company’s stockholders at an upcoming special meeting of the Company’s stockholders (“Stockholder Approval”) and will not expire. The Warrants are exercisable following receipt of Stockholder Approval and will expire on the fifth anniversary of the closing of the PIPE financing. The PIPE financing is expected to close on or about May 4, 2026, subject to the satisfaction of customary closing conditions. Announcement • Mar 10
Cue Biopharma Inc Presents New in Vitro Data for Cue-401 At World Immune Regulation Meeting Cue Biopharma, Inc. announced that it will deliver a poster presentation on the company’s lead asset, CUE-401, at the World Immune Regulation Meeting (WIRM) being held March 11-14, 2026 in Davos, Switzerland. The presentation will include new in vitro data that demonstrate the therapeutic potential of CUE-401 to restore immune balance for the treatment of autoimmune and inflammatory diseases. Natasha M. Girgis, Director, Translational Pharmacology will discuss new in vitro data that support CUE-401’s ability to directly inhibit proinflammatory immune cells via the direct effects of TGF-beta (TGF-ß). TGF-ß is a potent immunoregulatory cytokine that maintains peripheral tolerance by inhibiting diverse types of inflammatory immune cells and proinflammatory pathways, making it an attractive therapeutic target for treating autoimmune and inflammatory diseases. In addition to expanding Tregs, we show that CUE-401 controlled proinflammatory pathways via direct effects of TGF-ß on multiple cell types that contribute to autoimmune disease. In CD4+ T effector memory cells, CUE-401 showed TGF-ß-dependent suppression of proinflammatory cytokines, including Th1, Th2, and Th17 responses. In addition, the TGF-ß in CUE-401 prevented activated B cells from differentiating into plasma cells and limited antibody production. In natural killer (NK) cells, TGF-ß in CUE-401 counterbalanced the activating effects of interleukin-2 (IL-2), preventing proliferation and upregulation of proinflammatory cytokine production. CUE-401 is a novel bifunctional therapeutic that incorporates an innovative TGF-beta breathing-mask moiety with Cue Biopharma’s clinically validated interleukin-2 (IL-2) mutein in a single injectable biologic. The design of CUE 401 was inspired by Nobel Prize winning science in 2025 for the role of IL-2 and TGF-beta as essential components in helping establish immune tolerance by regulating FOXP3 signaling. CUE-401 is designed to promote immune regulation and tolerance by three complementary mechanisms: 1. Direct regulation of proinflammatory mechanisms by TGF-beta, 2. Expansion of existing Tregs by IL-2, and 3. Conversion of FOXP3-conventional CD4+ T cells into FOXP3+ induced Tregs through the coordinated provision of TGF-beta and IL-2 signals, both of which are required for the de novo induction of FOXP3 expression. Announcement • Feb 19
Cue Biopharma, Inc., Annual General Meeting, Apr 13, 2026 Cue Biopharma, Inc., Annual General Meeting, Apr 13, 2026. Announcement • Feb 18
Cue Biopharma Inc Announces Preclinical Safety and Tolerability Data for CUE-401 for the Treatment of Autoimmune and Inflammatory Diseases Cue Biopharma, Inc. announced preclinical safety and tolerability data that further supports the preclinical profile of CUE-401, the Company's lead autoimmune asset. Study design and key data highlights include: Two separate non-GLP studies in mice and non-human primates (NHPs) assessed the safety and tolerability of CUE-401 using a step-up dosing schedule, where animals successively received higher doses of CUE-401, weekly. CUE-401 was administered intravenously. Murine Study (n=24, 12 males, 12 females); Animals received escalating doses of CUE-401 at 1 mg/kg, 3 mg/kg, and 10 mg/kg All dose levels were well tolerated, and no adverse events were observed NHP Study (n=6, 3 males, 3 females); Core study: Animals received escalating doses of Cue-401 at 0.1 mg/kg, 0.3 mg/kg, and 1 mg/kg; All dose levels were well tolerated in the core study with no adverse observations; Follow-up dosing: Following observed tolerability and safety in the core study, animals were given an additional dose of CUE-401 a week later at 1 mg/kg (n=2 animals, 1 female, 1 male) or 3 mg/kg (n=4 animals, 2 male, 2 female); repeat dosing of CUE-401 at1 mg/kg was better tolerated than the repeat dosing at 3 mg/kg. Announcement • Aug 16
Cue Biopharma Announces Initiation of Investigator Sponsored Trial of Cue-102 in Recurrent Glioblastoma Multiforme Cue Biopharma, Inc. announced the initiation of an investigator sponsored trial (IST) in rGBM at the DFCI with the first patient in the trial having been dosed with CUE-102. The trial (NCT06917885) is a Phase 1b, open-label study of adjuvant CUE-102, the Company's drug product candidate targeting Wilms' Tumor 1 protein (WT1) expressing cancers. The principal investigator of the Phase 1b trial, David A. Reardon, MD, is the Clinical Director of the Center for Neuro-Oncology at DFCI and a leader in the field of immunotherapy for the treatment of brain cancer. These singular biologics are anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient's body. The binding affinity of IL-2 for its receptor has been successfully attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing the potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies. Announcement • Jul 17
Cue Biopharma, Inc. Reports New Complete Response and Confirms 50% Overall Response Rate in Ongoing Phase 1 Trial of CUE-101 and Pembrolizumab in Recurrent/Metastatic HPV+ Head and Neck Cancer Cue Biopharma, Inc. provided a clinical update on its most advanced asset, CUE-101, representative of the CUE-100 series. CUE-101 is currently being evaluated in a fully enrolled Phase 1 open-label, dose escalation and expansion study, for the treatment of HPV16+ driven recurrent/metastatic head and neck squamous cell carcinoma in second line (2L) and beyond patients as a monotherapy, and as a first line (1L) therapy in combination with pembrolizumab (KEYTRUDA®?). Announcement • Jul 02
Cue Biopharma, Inc. Provides Update on Most Advanced Clinical Stage Asset, CUE-101 at the DAVA 4th Hawaii Global Summit on Thoracic Malignancies Cue Biopharma, Inc. provided an update on its most advanced clinical stage asset, CUE-101, representative of the CUE-100 series. Dr. Dimitrios Colevas presented new data from the company's maturing Phase 1 trial evaluating CUE-101 in combination with KEYTRUDA (pembrolizumab) for patients with recurrent metastatic HPV+ head and neck squamous cell carcinoma (HNSCC). Data highlights include an overall response rate (ORR) of 50% (with 1 unconfirmed PR) in patients with combined positive score (CPS) >1 and an ORR of 50% observed in patients with low CPS scores (1-19). The Kaplan-Meier (K-M) estimate for median overall survival (mOS) is currently 32 months. Announcement • Jun 25
Cue Biopharma, Inc. Receives FDA Feedback on Pre-IND Briefing Document Reinforcing it's Intention to Advance IND Submission for CUE-401 to Address Unmet Need in the Treatment of Autoimmune Disease Cue Biopharma, Inc. announced it has received Pre-Investigational New Drug (Pre-IND) feedback from the U.S. Food and Drug Administration (FDA). The FDA reviewed the first-in-human trial design, including the Company's plan for dose escalation, proposed populations and safety monitoring plan. On the basis of the FDA feedback, the Company, intends to file an IND pending completion of final IND enabling studies. CUE-401 is the Company's lead autoimmune asset, a first-in-class bispecific fusion protein/molecule designed to induce and expand regulatory T cells (Tregs) in vivo through the co-activity of transforming growth factor beta (TGF-b) and a modified variant of interleukin 2 (IL-2). These findings suggest that CUE-401 acts by establishing a bispecific positive feedback loop' that not only increases nonspecific Treg populations, but critically, reduces and converts specific autoreactive T cells into transdifferentiated iTregs that are specific for the disease-causing autoantigens. Announcement • Apr 16
Cue Biopharma, Inc. has completed a Follow-on Equity Offering in the amount of $19.738528 million. Cue Biopharma, Inc. has completed a Follow-on Equity Offering in the amount of $19.738528 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 13,530,780
Price\Range: $0.79
Discount Per Security: $0.0474
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 11,469,216
Price\Range: $0.789
Discount Per Security: $0.04734
Security Name: Common Warrants
Security Type: Equity Warrant
Securities Offered: 6,249,999 Announcement • Mar 13
Cue Biopharma, Inc. Appoints Pasha Sarraf as Board of Directors Cue Biopharma, Inc. announced on March 10, 2025, Pasha Sarraf was appointed to the board of directors of the company, following the recommendation of the corporate governance and nominating committee of the board. Reported Earnings • Nov 17
Third quarter 2024 earnings released: US$0.17 loss per share (vs US$0.24 loss in 3Q 2023) Third quarter 2024 results: US$0.17 loss per share (improved from US$0.24 loss in 3Q 2023). Revenue: US$3.34m (up 59% from 3Q 2023). Net loss: US$8.66m (loss narrowed 21% from 3Q 2023). Revenue is forecast to grow 35% p.a. on average during the next 3 years, compared to a 21% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 16% per year but the company’s share price has fallen by 53% per year, which means it is significantly lagging earnings. Announcement • Nov 15
Cue Biopharma Announces Strategic Organizational Transition Cue Biopharma, Inc. announced that Daniel Baker, M.D., will join Cue Biopharma as interim chief development officer (CDO) effective November 25, 2024. Dr. Anish Suri will transition from his current role of president & chief scientific officer (CSO) and will serve the company as principal research and immunology advisor effective as of the same date. Dr. Baker has over 20 years of drug development experience in the pharmaceutical industry. From 2000 to 2019, he served as Vice President, Immunology R&D at Johnson & Johnson (Janssen/Centocor) where his responsibilities included clinical development of Remicade, Simponi and Stelara, as well as other major clinical drug programs. His supervision and oversight of numerous Phase I-III trials in multiple disease areas, led to more than 15 regulatory approvals in the US, Europe and Japan. In 2015, Dr. Baker assumed the role of Disease Area Stronghold Leader at Janssen where he was responsible for Phase II & III clinical development plans for rheumatology products and the overall portfolio strategy in rheumatology and immunology. Following his retirement from Janssen in 2019, Dr. Baker served as CEO and founder of Kira Therapeutics and more recently as Executive Director on the board of Galapagos Therapeutics from April 2022 until October 2024. Dr. Baker received his Medical Degree from the University of Pennsylvania and completed his Medical Residency at Hershey Medical Center and Fellowship in Rheumatology and Immunology at the University of Pennsylvania, followed by a Research Fellowship in Rheumatology at Mass General Hospital. Announcement • Nov 09
Cue Biopharma, Inc. Presents Positive Updated Data from its Phase 1 Trials of CUE-101 and CUE-102 in Head and Neck Cancer and WT1 Positive Cancers at the SITC 39th Annual Meeting Cue Biopharma, Inc. presented updated data from its Phase 1 dose escalation and expansion trial evaluating its lead oncology asset from the Immuno-STAT CUE-100 series, CUE-101, in patients with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). The data was presented in an oral session at the Society for Immunotherapy of Cancer’s 39th Annual Meeting (SITC 2024) being held in Houston, Texas and virtually November 6-10. In addition, on Saturday, November 9, 2024, the Company will present a poster with data from its Phase 1 trial evaluating monotherapy activity of its second clinical asset from the CUE-100 series, CUE-102, for the treatment of patients with late-stage Wilms Tumor 1 positive (WT1+) colorectal, gastric, ovarian and pancreatic cancers. Data showed substantial evidence of selective expansion of WT1-specific T cells, with anti-tumor activity and a favorable tolerability profile with no dose limiting toxicities (DLTs) observed. Key data highlights from the expansion portion of the trial evaluating CUE-101 at the recommended Phase 2 dose (RP2D) of 4mg/kg in combination with pembrolizumab in 1L HPV+ R/M HNSCC patients (data cutoff of September 11, 2024) include: ORR of 46% and overall disease control rate (DCR) of 75% in patients with combined positive score (CPS) =1, compared to an ORR of 19% observed with pembrolizumab alone in the historical third-party KEYNOTE-048 trial. This includes one complete response (CR) and 10 partial responses (PR), in addition to seven durable stable diseases (DSD) of >12 weeks. Survival metrics continue to mature: 12-month OS of 91.3% compared to 51% with pembrolizumab alone in the historical KEYNOTE-048 trial. mOS of 21.8 months compared to 12.3 months in the historical KEYNOTE-048 trial. ORR of 50% in patients with PD-L1 CPS 1-19. Key data highlights from the CUE-101 expansion portion of the Phase 1b trial evaluating CUE-101 at the RP2D as monotherapy with 20 second line and beyond (2L+) patients (majority third line and beyond (3L+) (data cutoff of September 11, 2024) include: mOS of 20.8 months, notably longer than the historical mOS of 7.5 and 8.4 months reported in historical third-party 2L R/M HNSCC trials: CheckMate 141 and KEYNOTE-040, respectively. CUE-101 has been well tolerated as a monotherapy and in combination with pembrolizumab. No significant safety concerns have emerged in either the monotherapy or combination trials, and adverse events have been readily managed with appropriate medical care. Key data highlights from the completed CUE-102 dose escalation and ongoing dose expansion parts of the Phase 1 clinical trial (data cutoff of October 29, 2024) include: 67% overall DCR in late-stage pancreatic cancer patients treated with CUE-102 at 2 and 4mg/kg, including an unconfirmed PR with a 40% decrease in tumor burden. Evidence of selective stimulation and expansion of WT1-specific CD8 T cells, with no apparent increase in total numbers of non-specific CD8 T cells. No dose-limiting toxicities occurred in patients treated during the dose escalation phase at doses ranging between 1-8mg/kg of CUE-102. The CUE-100 series consists of Fc-fusion biologics that present two signals to T cells. Signal #1 is a tumor-specific peptide linked to a major histocompatibility complex (pMHC) to enable selectivity and specificity. Signal #2 is a rationally engineered interleukin 2 (IL-2) molecule to trigger T cell activation. These singular biologics are anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient’s body. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing the potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies. CUE-101 is Cue Biopharma’s lead clinical drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics. It is designed to activate and expand HPV16 tumor-specific T cells by presenting the HPV E7 protein to the HPV-specific T cell receptor. CUE-101 is currently being evaluated in a fully enrolled Phase 1 open-label, dose escalation and expansion study, for the treatment of HPV16+ driven recurrent/metastatic head and neck squamous cell carcinoma in second line (2L) and beyond patients as a monotherapy, and as a first line (1L) therapy in combination with pembrolizumab (KEYTRUDA). CUE-102 is Cue Biopharma’s second clinical drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics. It is designed to activate and expand Wilms’ Tumor 1 (WT1)-specific T cells by presenting the WT1 peptide to the WT1- specific T cell receptor. WT1 is a well-recognized onco-fetal protein known to be over-expressed in a number of cancers, including solid tumors and hematologic malignancies. CUE-102 is being evaluated in a Phase 1 open label, two-part dose escalation and expansion study, for patients with late-stage colorectal, gastric/gastroesophageal junction, pancreatic and ovarian cancers that express WT1. Announcement • Sep 28
Cue Biopharma, Inc. has completed a Follow-on Equity Offering in the amount of $12 million. Cue Biopharma, Inc. has completed a Follow-on Equity Offering in the amount of $12 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 11,564,401
Price\Range: $0.5
Discount Per Security: $0.03
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 12,435,599
Price\Range: $0.499
Discount Per Security: $0.02994 Announcement • Sep 27
Cue Biopharma, Inc. has filed a Follow-on Equity Offering. Cue Biopharma, Inc. has filed a Follow-on Equity Offering.
Security Name: Common Stock
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant Announcement • Sep 11
Cue Biopharma, Inc. Appoints Lucinda Warren as Chief Business Officer Cue Biopharma, Inc. announced the appointment of industry veteran Lucinda Warren as chief business officer (CBO). With an extensive background and proven expertise in strategic transactions, portfolio optimization and alliance management through her extensive tenure at Johnson &Johnson and Jansen, Ms. Warren will play a pivotal role in advancing Cue Biopharmas core corporate objectives following the company's recent business restructuring and autoimmune program prioritization. Ms. Warren has over 30 years of global experience in the pharmaceutical and biotechnology sectors. Most recently, she served as vice president of business development for Neuroscience and Japan Regionally at Johnson &Johnson from 2014 to 2024, where she was responsible for end-to-end business development, including licensing, mergers and acquisitions, and alliance management. Her leadership was instrumental in optimizing resources, fostering high-performing teams, and cultivating strong relationships with stakeholders. Lucinda's extensive experience also includes significant roles at Janssen Cilag Australia and Centocor/Janssen Biologics, where she led business units and managed global transitions, consistently delivering value through strategic transactions. Lucinda holds a Bachelor of Science in Biological Sciences with a minor in Neurology from the University of Alberta and is an alumna of the Women in Bio Board Room Ready program. She currently serves on the boards of International School Services (ISS) and the Association of Strategic Alliance Professionals (ASAP), contributing her expertise in finance and governance. Announcement • Aug 18
Cue Biopharma Receives Non-Compliance Letter from Nasdaq Regarding Minimum Bid Price Requirement On August 15, 2024, Cue Biopharma, Inc. (the Company") received a deficiency letter (the Notice") from the Listing Qualifications Department (the Staff") of the Nasdaq Stock Market, LLC (Nasdaq") notifying the Company that, for the last 30 consecutive business days, the bid price for the Company's common stock had closed below $1.00 per share, which is the minimum bid price required to maintain continued listing on The Nasdaq Capital Market under Nasdaq Listing Rule 5550(a)(2) (the Minimum Bid Requirement"). The Notice has no immediate effect on the listing of the Company's common stock. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company has an initial period of 180 calendar days (which expires on February 11, 2025) to regain compliance with the Minimum Bid Requirement. To regain compliance, the closing bid price of the Company's common stock must be at least $1.00 per share for a minimum of 10 consecutive business days during this 180 calendar day period, at which time the Staff will provide written notification to the Company that it complies with the Minimum Bid Requirement, unless the Staff exercises its discretion to extend this ten-day period pursuant to Nasdaq Listing Rule 5810(c)(3)(H). If the Company does not regain compliance with the Minimum Bid Requirement during the initial 180 calendar day period, it may be eligible for an additional 180 calendar day compliance period. To qualify, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the Minimum Bid Requirement, and will need to provide written notice to the Staff of its intention to cure the deficiency during the additional compliance period by effecting a reverse stock split, if necessary. However, if during the second compliance period it appears to the Staff that the Company will not be able to cure the deficiency, or if the Company does not meet the other listing standards, the Staff could provide notice that the Company's common stock will become subject to delisting. Upon receipt of such notice, under Nasdaq rules, the Company may appeal the Staff's delisting determination to a Hearings Panel (the Panel"). The Company expects that its common stock would remain listed pending the Panel's decision. However, if the Company does appeal the delisting determination by the Staff to the Panel, there can be no assurance that such appeal would be successful, or that the Company will be able to regain compliance with the Minimum Bid Requirement or maintain compliance with the other listing requirements. The Company intends to actively monitor the closing bid price of its common stock and will evaluate available options to regain compliance with the Minimum Bid Requirement. However, there can be no assurance that the Company will be able to regain compliance with the Minimum Bid Requirement. New Risk • Aug 16
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$39m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$39m free cash flow). Share price has been highly volatile over the past 3 months (14% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$67m net loss in 3 years). Shareholders have been diluted in the past year (8.2% increase in shares outstanding). Market cap is less than US$100m (€26.3m market cap, or US$28.9m). Reported Earnings • Aug 16
Second quarter 2024 earnings released: US$0.20 loss per share (vs US$0.29 loss in 2Q 2023) Second quarter 2024 results: US$0.20 loss per share (improved from US$0.29 loss in 2Q 2023). Revenue: US$2.66m (up 92% from 2Q 2023). Net loss: US$10.2m (loss narrowed 23% from 2Q 2023). Revenue is forecast to grow 62% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 13% per year but the company’s share price has fallen by 60% per year, which means it is significantly lagging earnings. Announcement • Jun 10
Cue Biopharma, Inc. Appoints Michael J. Fox to the Board of Directors and the Compensation Committee On June 5, 2024, Michael J. Fox was appointed to the board of directors and the Compensation Committee of the Board of Cue Biopharma, Inc., following the recommendation of the Corporate Governance and Nominating Committee of the Board. Reported Earnings • May 15
First quarter 2024 earnings released: US$0.25 loss per share (vs US$0.29 loss in 1Q 2023) First quarter 2024 results: US$0.25 loss per share (improved from US$0.29 loss in 1Q 2023). Revenue: US$1.72m (up US$1.53m from 1Q 2023). Net loss: US$12.3m (loss narrowed 5.8% from 1Q 2023). Revenue is forecast to grow 64% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 10% per year but the company’s share price has fallen by 47% per year, which means it is significantly lagging earnings. Reported Earnings • May 10
First quarter 2024 earnings released: US$0.25 loss per share (vs US$0.29 loss in 1Q 2023) First quarter 2024 results: US$0.25 loss per share (improved from US$0.29 loss in 1Q 2023). Revenue: US$1.72m (up US$1.53m from 1Q 2023). Net loss: US$12.3m (loss narrowed 5.8% from 1Q 2023). Revenue is forecast to grow 53% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 10% per year but the company’s share price has fallen by 50% per year, which means it is significantly lagging earnings. Announcement • Apr 28
Cue Biopharma, Inc., Annual General Meeting, Jun 05, 2024 Cue Biopharma, Inc., Annual General Meeting, Jun 05, 2024, at 09:00 US Eastern Standard Time. Agenda: To consider the election of six nominees to the Board of Directors; to consider the approval, on a non-binding advisory basis, of the compensation of named executive officers; to consider the ratification of the appointment of RSM US LLP as independent registered public accounting firm for the fiscal year ending December 31, 2024; and to consider the transaction of any other business that may properly come before the Annual Meeting or any adjournment or postponement thereof. New Risk • Apr 10
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 2.3% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (10% average weekly change). Earnings are forecast to decline by an average of 2.3% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$90m net loss in 3 years). Shareholders have been diluted in the past year (13% increase in shares outstanding). Market cap is less than US$100m (€85.1m market cap, or US$92.4m). Reported Earnings • Mar 30
Full year 2023 earnings released: US$1.11 loss per share (vs US$1.49 loss in FY 2022) Full year 2023 results: US$1.11 loss per share (improved from US$1.49 loss in FY 2022). Revenue: US$5.49m (up 341% from FY 2022). Net loss: US$50.7m (loss narrowed 4.3% from FY 2022). Revenue is forecast to grow 50% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 9% per year but the company’s share price has fallen by 45% per year, which means it is significantly lagging earnings. New Risk • Mar 13
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 0.2% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (11% average weekly change). Earnings are forecast to decline by an average of 0.2% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$67m net loss in 3 years). Shareholders have been diluted in the past year (4.8% increase in shares outstanding). Revenue is less than US$5m (US$3.8m revenue). Market cap is less than US$100m (€73.0m market cap, or US$79.9m). New Risk • Feb 18
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: €91.7m (US$98.8m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risk Share price has been highly volatile over the past 3 months (11% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$57m net loss in 3 years). Shareholders have been diluted in the past year (4.8% increase in shares outstanding). Revenue is less than US$5m (US$3.8m revenue). Market cap is less than US$100m (€91.7m market cap, or US$98.8m). Reported Earnings • Nov 05
Third quarter 2023 earnings released: US$0.24 loss per share (vs US$0.31 loss in 3Q 2022) Third quarter 2023 results: US$0.24 loss per share. Net loss: US$11.0m (flat on 3Q 2022). Revenue is forecast to grow 60% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in Germany. Announcement • Nov 04
Cue Biopharma Presents New Positive Data from Phase 1 Trials of CUE-101 in Head and Neck Cancer and Cue-102 in Wilms' Tumor 1 Positive Cancers at SITC 2023 Cue Biopharma, Inc. announced the presentation of new positive data from its ongoing fully enrolled Phase 1 trials evaluating its lead interleukin-2 (IL-2)-based T cell engager, CUE-101, as a monotherapy and in combination with KEYTRUDA®? (pembrolizumab) for patients with recurrent/metastatic HPV+ head and neck squamous cell carcinoma (HNSCC). New clinical data will also be reported from the company's ongoing Phase 1 trial evaluating its second candidate, CUE-102, for the treatment of Wilms' Tumor 1 positive (WT1+) recurrent/metastatic cancers. The data will be presented in two posters at the Society for Immunotherapy of Cancer's 38th Anniversary Annual Meeting (SITC 2023) being held in San Diego, California and virtually November 1-5. Key data highlights from the CUE-102 Phase 1 clinical trial to date include: No DLTs reported to date in patients treated during the dose escalation phase at doses ranging between 1-8mg/kg of CUE-102 intravenously every 3 weeks; a MTD has not been reached. 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 achieve profitability; potential setbacks in the company's research and development efforts including negative or inconclusive results from its preclinical studies 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, 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 the recent COVID-19 pandemic, including possible effects on the company's trials; negative or inconclusive results from the company's clinical trials or preclinical studies or serious and unexpected drug-related side effects or other safety issues experienced by participants in 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; operations and clinical 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 in Management's Discussion and Analysis of Financial Condition and Results of Operations sections of Operations sections of the company's financial condition. New Risk • Oct 04
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: €90.2m (US$94.6m) This is considered a minor risk. Companies with a small market capitalization are most likely businesses that have not yet released a product to market or are simply a very small company without a wide reach. Either way, risk is elevated with these companies because there is a chance the product may not come to fruition or the company's addressable market or demand may not be as large as expected. In addition, if the company's size is the main factor, it is less likely to have many investors and analysts following it and scrutinizing its performance and outlook. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (9.0% average weekly change). Earnings are forecast to decline by an average of 5.3% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$75m net loss in 3 years). Shareholders have been diluted in the past year (27% increase in shares outstanding). Revenue is less than US$5m (US$1.8m revenue). Market cap is less than US$100m (€90.2m market cap, or US$94.6m). Announcement • Sep 27
Cue Biopharma Announces Completion of Patient Enrollment in Phase 1b Study of CUE-101 in Combination with KEYTRUDA®? Cue Biopharma, Inc. announced that it has completed patient enrollment in its Phase 1 clinical trial (NCT03978689 [2]) evaluating CUE-101, the company’s lead interleukin 2 (IL-2)-based biologic from the CUE-100 series, in combination with KEYTRUDA® (pembrolizumab) as first-line treatment for patients with human papilloma virus positive recurrent/metastatic head and neck squamous cell carcinoma (HPV+ R/M HNSCC). The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient’s body. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing the potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies. Announcement • Sep 15
Cue Biopharma, Inc. Announces Resignation of Aaron Fletcher as Member of the Board of Directors, Effective October 9, 2023 On September 12, 2023, Aaron Fletcher notified Cue Biopharma, Inc. (the “Company”) of his decision to resign as a member of the Board of Directors of the Company (the “Board”) and all committees thereof, effective on October 9, 2023. New Risk • Aug 18
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of German stocks, typically moving 9.4% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (9.4% average weekly change). Earnings are forecast to decline by an average of 5.3% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$75m net loss in 3 years). Shareholders have been diluted in the past year (27% increase in shares outstanding). Revenue is less than US$5m (US$1.8m revenue). Reported Earnings • Aug 09
Second quarter 2023 earnings released: US$0.29 loss per share (vs US$0.37 loss in 2Q 2022) Second quarter 2023 results: US$0.29 loss per share (improved from US$0.37 loss in 2Q 2022). Net loss: US$13.2m (flat on 2Q 2022). Revenue is forecast to grow 59% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 5% per year but the company’s share price has fallen by 43% per year, which means it is significantly lagging earnings. Announcement • May 26
Cue Biopharma, Inc. Presents Positive Data Update from Ongoing Phase 1 Trials of Cue-101 for Recurrent/Metastatichpv+ Head and Neck Squamous Cell Carcinoma At the 2023 American Society of Clinical Oncology Annual Meeting Cue Biopharma, Inc. announced the presentation of a positive data update from its ongoing Phase 1 clinical trials evaluating its lead biologic from the IL-2-based CUE-100 series, CUE-101, for the treatment of patients with human papilloma virus (HPV16+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) as a monotherapy and in combination with pembrolizumab. Key data highlights from the Phase 1b trial in combination with pembrolIZumab at the RP2D of 4mg/kg, with 14 evaluable patients as of the data cutoff date of May 15, 2023 include: Overall response rate of 40% with 4 out of 5 confirmed PRs occurring in tumors with low PD-L1 expression as influenced by combined positive scores (CPS) of 20 or less; Importantly, all 5 patients with a confirmed PR demonstrated >99% reduction in circulating cell-free HPV DNA (HPV cfDNA); Median duration of response is 35 weeks with a median progression free survival (PFS) approaching 5 months. Key data highlights from the phase 1b CUE-101 monotherapy patient expansion portion of the trial at the RP2D of4mg/kg to date, include: Current mOS approaching 14 months compares favorably to the historical mOS of 7.5 and 8.4 months reported from third-party clinical trials with checkpoint inhibitors in 2L R/M HNSCC in CheckMate 1411 and KEYNOTE-040 respectively; CUE-101 has been well tolerated to date as monotherapy and in combination with Pembrolizumab; Durable PR greater than 9 months and 6 DSD including a patient remaining on therapy for 2 years, resulting in an overall clinical benefit rate of 35%. Announcement • May 11
Cue Biopharma, Inc. has completed a Follow-on Equity Offering in the amount of $17.6 million. Cue Biopharma, Inc. has completed a Follow-on Equity Offering in the amount of $17.6 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 476,187
Price\Range: $14.700107
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 1,919,826
Price\Range: $5.521334
Transaction Features: At the Market Offering Reported Earnings • May 10
First quarter 2023 earnings released: US$0.29 loss per share (vs US$0.44 loss in 1Q 2022) First quarter 2023 results: US$0.29 loss per share (improved from US$0.44 loss in 1Q 2022). Net loss: US$13.1m (loss narrowed 8.0% from 1Q 2022). Revenue is forecast to grow 73% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Germany. Over the last 3 years on average, earnings per share has increased by 5% per year but the company’s share price has fallen by 43% per year, which means it is significantly lagging earnings. Reported Earnings • Mar 22
Full year 2022 earnings released: US$1.49 loss per share (vs US$1.41 loss in FY 2021) Full year 2022 results: US$1.49 loss per share (further deteriorated from US$1.41 loss in FY 2021). Net loss: US$53.0m (loss widened 20% from FY 2021). Revenue is forecast to grow 60% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in Europe. Over the last 3 years on average, earnings per share has increased by 5% per year but the company’s share price has fallen by 36% per year, which means it is significantly lagging earnings. Announcement • Feb 17
Cue Biopharma, Inc. Announces the Appointment of Rafi Ahmed to its Scientific Advisory Board Cue Biopharma, Inc. announced that world-renowned immunologist and distinguished thought leader Dr. Rafi Ahmed, Ph.D., has joined its Scientific Advisory Board (SAB). Dr. Ahmed’s research has significantly shaped the scientific community’s current understanding of immunity in the context of viral infections and cancer. His extensive work on defining T cell exhaustion along with detailing molecular underpinnings of T cell differentiation and effector responses have been seminal in establishing novel areas of research and therapeutic applications. His laboratory has pioneered highly sophisticated and cellular and molecular techniques to study antigen-specific responses and immunological memory in murine, primate, and human systems. r. Ahmed is the Director of the Emory Vaccine Center at Emory University. He is also the co-leader of the Cancer Immunology research program at Winship Cancer Institute of Emory University and a Professor in the Department of Microbiology and Immunology at the Emory University School of Medicine. For his ground-breaking research contributions, Dr. Ahmed is an elected member of the National Academy of Science. He is also recognized as a Georgia Research Alliance Eminent Scholar and a Fellow of the Academy of Immuno-Oncology. Announcement • Jan 24
Cue Biopharma, Inc. Announces Executive Changes Cue Biopharma, Inc. announced that Matteo Levisetti, M.D., senior vice president (SVP) of clinical development at Cue Biopharma, has been promoted to chief medical officer (CMO) effective January 17, 2023. Current acting CMO Kenneth Pienta, M.D., has transitioned from his current role and will serve as a clinical advisor to the company effective as of the same date. Dr. Levisetti holds extensive experience leading global clinical development for mid and large-size pharmaceutical companies. Prior to joining Cue Biopharma in 2021, he held CMO positions at DNAtrix and previously at Dauntless Pharmaceuticals, where he directed and managed clinical development and operations, and regulatory strategy for a number of endocrinology and oncology assets. Previously, he directed immuno-oncology programs as executive director of clinical development at Mirati Therapeutics. Before joining Mirati, Dr. Levisetti served as global head & vice president, Translational Medicine, Immunology and Inflammation at Roche Pharma Research & Early Development. Prior to that, he held several senior clinical development positions at Pfizer, where he led multiple early clinical development programs across several therapeutic areas, including endocrinology, immunology and oncology. Dr. Levisetti received his medical degree from the University of Chicago Pritzker School of Medicine and served on the faculty at Washington University School of Medicine prior to his transition to leadership roles in industry. Announcement • Nov 16
Cue Biopharma, Inc. announced that it expects to receive $29.999992 million in funding Cue Biopharma, Inc. announced that it has entered into a security purchase agreement for the issuance of 7,656,966 shares at a price of $3.265 per share for gross proceeds of $24,999,993.99 and pre-funded warrants to purchase an aggregate of 1,531,440 shares of common stock, and, in each case, accompanying warrants to purchase an aggregate of up to 9,188,406 additional shares of common stock at a price of $3.265 per share and accompanying warrant on November 14, 2022. The exercise price of the warrants is $3.93 per share, or if exercised for a pre-funded warrant in lieu thereof, $3.9299 per pre-funded warrant. The warrants are exercisable at any time after they are issued and ending on the fifth anniversary of the closing. The pre-funded warrants are exercisable at any time after they are issued and will not expire. The company will issue the securities pursuant to exemption provided under Regulation D. The transaction is expected to close on November 16, 2022. Announcement • Nov 11
Cue Biopharma, Inc. Presents New Positive Data from Ongoing Phase 1 Trial of Cue-101 in Combination with Keytruda for Recurrent/Metastatic Hpv+ Head and Neck Cancer At the Society for Immunotherapy of Cancer’s (SITC) 37th Annual Meeting Cue Biopharma, Inc. announced the presentation of new positive data from its ongoing Phase 1 trial evaluating its lead interleukin 2 (IL-2)-based biologic, CUE-101 in combination with pembrolizumab (KEYTRUDA), as a first line therapy for patients with recurrent/metastatic HPV+ head and neck squamous cell carcinoma (HNSCC). The data will be presented in a poster at the Society for Immunotherapy of Cancer’s 37th Annual Meeting (SITC 2022), to be held in Boston, Massachusetts and virtually on November 8-12, 2022. The poster will also provide an update from the Company’s ongoing fully enrolled Phase 1b trial evaluating CUE-101 monotherapy as third line and beyond therapy in the same patient population. Additionally, the Company will present two posters discussing the design of its ongoing Phase 1 trial evaluating its second IL-2 based candidate, CUE-102, for the treatment of Wilms’ Tumor 1 positive (WT1+) malignancies, and preclinical data regarding its mechanistic effect in vitro and in vivo. Key data highlights from the CUE-101 dose escalation and patient expansion portion of the Phase 1 trial in combination with pembrolizumab with 16 evaluable patients to date, include: Overall response rate (ORR) of 40% and a clinical benefit rate (CBR) of 70% in the first 10 evaluable patients treated at the recommended Phase 2 dose (RP2D) of 4 mg/kg of CUE-101 and 200 mg of pembrolizumab administered every three weeks – This includes four confirmed partial responses (cPR) in addition to three durable stable disease (DSD) of = 12 weeks. These responses include patients with low PD-L1 expression (combined positive score (CPS) less than 20). At the CUE-101 2 mg/kg dose plus pembrolizumab (n=3), one patient experienced a cPR and one DSD, for a CBR of 67%. At the CUE-101 1 mg/kg dose plus pembrolizumab (n=3), one patient experienced DSD, for a CBR of 33%. Notably, tumor reduction from baseline in the five patients with confirmed PRs was between 35% and 69%. Key data highlights from the CUE-101 expansion portion of the Phase 1b trial at the RP2D as a monotherapy to date, include: 42% overall clinical benefit rate, including one PR of > 42 weeks duration and seven DSD. Median overall survival approaching greater than 12 months in third line and beyond (3L+) patients treated with C E-101 monotherapy, which is 50% greater than current standard of care with anti-PD-1 therapies in second line (2L) patients. CUE-101 continued to show a favorable tolerability profile both as monotherapy and in combination with pembrolizumab. Ken Pienta, M.D., acting chief medical officer of Cue Biopharma, added, “This new data from combination study demonstrates early evidence of complementary mechanistic activity of CUE-101 with pembrolizumab. In addition, the sustained clinical benefit rate with CUE-101 as monotherapy is very encouraging and has continued to demonstrate proof-of-concept of CUE-101 as a single agent. Overall, the data shows the potential of CUE-101 to provide patients with an improved clinical benefit rate and with lower toxicity than current standard of care. The company looks forward to continuing to evaluate data from the trial in addition to defining the potential registrational trial for CUE-101, which the company anticipates in mid-2023.” Key data highlights from CUE-102 preclinical study to date include: CUE-102 selectively activated and expanded WT1-specific CD8+ T cells from peripheral blood mononuclear cells (PBMC) of healthy donors. CUE-102 elicited and expanded WT1-specific CD8+ T cells from naïve mice without significantly altering the frequencies of other immune lineages. The WT1-specific CD8+ T cells expanded in vivo exhibited polyfunctionality and selectively killed WT1-presenting target cells in vitro and in vivo. Announcement • Oct 06
Cue Biopharma Grants FDA Fast Track Designation for CUE-101 for the Treatment of Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma Cue Biopharma, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to CUE-101, its lead clinical drug candidate from the CUE-100 series of interleukin 2 (IL-2)- based biologics, for the treatment of patients with human papilloma virus (HPV16+) recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) as a monotherapy and in combination with pembrolizumab (KEYTRUDA(R)). Fast Track is a process designed to facilitate the development and expedite the review of drug candidates to treat serious conditions and fulfill an unmet medical need. A therapeutic candidate that receives Fast Track designation may be eligible for more frequent interactions with the FDA to discuss the therapeutic candidate's development plan. Therapeutic candidates with Fast Track designation may be eligible for accelerated approval and priority review if supported by clinical data. CUE-101 is currently being evaluated in a Phase 1b trial (NCT03978689) as a monotherapy for the treatment of second line and beyond patients with HPV16+ R/M HNSCC and as a first-line treatment in a Phase 1 dose escalation and expansion trial in combination with KEYTRUDA(R) for the same patient population. Announcement • Aug 23
Cue Biopharma Doses First Patient in Phase 1 Study of CUE-102 for Wilms’ Tumor 1 (WT1) - Expressing Cancers Cue Biopharma, Inc. announced that it has dosed the first patient in a Phase 1 dose escalation study evaluating CUE-102, its second clinical drug candidate from the CUE-100 series of interleukin 2 (IL-2)-based biologics, as a monotherapy for the treatment of patients with Wilms’ Tumor 1 (WT1)-positive recurrent/metastatic cancers. The study will initially focus on colorectal, gastric, pancreatic, and ovarian cancers. WT1 is a well-recognized onco-fetal protein that is known to be over-expressed in several cancers, including solid tumors and hematologic malignancies such as gastric, glioblastoma, pancreatic, ovarian, endometrial, breast, lung, colorectal and acute myeloid leukemia (AML). Patients with WT1-expressing cancers, and those with recurrent metastatic disease, represent an important unmet clinical need and underscore the opportunity for this promising new therapeutic. Reported Earnings • Aug 06
Second quarter 2022 earnings released: US$0.37 loss per share (vs US$0.33 loss in 2Q 2021) Second quarter 2022 results: US$0.37 loss per share (down from US$0.33 loss in 2Q 2021). Revenue: US$26.0k (down 99% from 2Q 2021). Net loss: US$13.2m (loss widened 28% from 2Q 2021). Over the next year, revenue is forecast to grow 2.9%, compared to a 24% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 11% per year but the company’s share price has fallen by 26% per year, which means it is significantly lagging earnings. Announcement • Jun 23
Cue Biopharma, Inc. Announces Resignation of Cameron Gray as Member of the Board of Directors and All Committees Cue Biopharma, Inc. announced that Cameron Gray notified of his decision to resign as a member of the Board of Directors of the Company and all committees thereof, effective immediately. Mr. Gray’s decision to resign from the Board was not related to any disagreement with the Company on any matter relating to its operations, policies or practices. Recent Insider Transactions • Jun 01
Insider recently bought €98k worth of stock On the 27th of May, Frank Morich bought around 28k shares on-market at roughly €3.50 per share. This was the largest purchase by an insider in the last 3 months. Insiders have collectively bought €141k more in shares than they have sold in the last 12 months. Announcement • May 12
U.S. Food and Drug Administration Accepts Cue Biopharma, Inc Investigational New Drug Application Cue Biopharma, Inc. announced that the U.S. food and drug administration (FDA) has accepted the company's investigational new drug (IND) application for the evaluation of CUE-102, its second interleukin 2 (IL-2)-based CUE-100 series biologic, in a dose escalation and expansion monotherapy Phase 1 trial, which will have a starting dose of 1 mg/kg for the treatment of Wilms’ Tumor 1 (WT1)-positive recurrent/metastatic cancers, with initial focus on gastric, pancreatic, ovarian and colon cancers. CUE-102 supports the modularity of the IL-2 based CUE-100 series as the core biologic framework is largely conserved with the primary difference being the incorporation of the WT1 T cell epitope. The IND acceptance allowing the dose escalation trial to begin dosing at 1 mg/kg was supported by the safety and tolerability data from the CUE-101 trial. CUE-101, the first biologic from the CUE-100 series, had a starting dose of 0.06 mg/kg and required approximately 9 months to dose escalate from 0.06 mg/kg to 1 mg/kg. As such, the starting dose of CUE-102 (targeting WT1 expressing cancers) may provide substantive time and cost savings for potentially demonstrating tolerability at therapeutically effective doses. Reported Earnings • May 11
First quarter 2022 earnings released: US$0.44 loss per share (vs US$0.41 loss in 1Q 2021) First quarter 2022 results: US$0.44 loss per share (down from US$0.41 loss in 1Q 2021). Revenue: US$1.00m (down 36% from 1Q 2021). Net loss: US$14.3m (loss widened 14% from 1Q 2021). Over the next year, revenue is expected to shrink by 21% compared to a 37% growth forecast for the industry in Germany. Over the last 3 years on average, earnings per share has increased by 14% per year but the company’s share price has fallen by 19% per year, which means it is significantly lagging earnings. Announcement • May 02
Cue Biopharma, Inc., Annual General Meeting, Jun 09, 2022 Cue Biopharma, Inc., Annual General Meeting, Jun 09, 2022, at 09:00 US Eastern Standard Time. Agenda: To consider the election of seven nominees to the Board of Directors; to consider the ratification of the appointment of RSM US LLP as the company's independent registered public accounting firm for the fiscal year ending December 31, 2022; and to consider the transaction of any other business that may properly come before the Annual Meeting or any adjournment or postponement thereof. Reported Earnings • Mar 18
Full year 2021 earnings: EPS in line with analyst expectations despite revenue beat Full year 2021 results: US$1.41 loss per share (up from US$1.56 loss in FY 2020). Revenue: US$14.9m (up 374% from FY 2020). Net loss: US$44.2m (loss narrowed 1.4% from FY 2020). Revenue exceeded analyst estimates by 62%. Over the next year, revenue is expected to shrink by 28% compared to a 75% growth forecast for the pharmaceuticals industry in Germany. Over the last 3 years on average, earnings per share has increased by 14% per year but the company’s share price has fallen by 17% per year, which means it is significantly lagging earnings. Reported Earnings • Nov 10
Third quarter 2021 earnings released: US$0.41 loss per share (vs US$0.34 loss in 3Q 2020) The company reported a solid third quarter result with improved revenues and control over costs, although losses increased. Third quarter 2021 results: Revenue: US$2.40m (up 240% from 3Q 2020). Net loss: US$13.0m (loss widened 30% from 3Q 2020). Over the last 3 years on average, earnings per share has increased by 14% per year but the company’s share price has increased by 23% per year, which means it is tracking significantly ahead of earnings growth. Announcement • Oct 01
Cue Biopharma, Inc. Announces Publication in Nature Journal, Scientific Reports, of Immunotherapeutic Platforms Immuno-STAT and Neo-STAT Cue Biopharma, Inc. announced the publication of research titled “Peptide-HLA-based immunotherapeutics platforms for direct modulation of antigen-specific T cells” in the peer-reviewed Nature journal, Scientific Reports. The article describes Cue Biopharma’s IL-2 based CUE-100 series technology platforms, Immuno-STAT™ (Selective Targeting and Alteration of T cells) and Neo-STAT™, being leveraged for the development of first-in-class biologics that enable selective activation of cancer-killing immune T cells within the patient’s body. Key aspects of Cue Biopharma’s technologies discussed in the article include: The Immuno-STAT platform enables development of first-in-class off-the-shelf biologic molecules designed to selectively engage and activate disease-relevant T cells via the T cell receptors (TCR), mimicking the natural immune process, through the presentation of complimentary and synergistic signals, or “cues.” An Immuno-STAT is engineered to include: A first signal, or “cue” involving the presentation of a targeted and specific epitope, via a major histocompatibility (MHC)-peptide complex, to T cell receptors, or TCRs, of disease-specific T cells, to selectively engage a repertoire of T cells relevant to a particular disease such as cancer. A corresponding second signal, or “cue” comprising the immunostimulant IL-2 molecule engineered with particular modifications for activation and expansion of CD8+ cytotoxic T cells, the relevant type of T cells with cancer-killing activity and minimize off-target binding and activation. The Immuno-STAT is constructed upon a portion of a human antibody (the “Fc portion”) that serves as the molecule’s backbone or scaffold and provides manufacturability and structural stability. Through this design, Immuno-STATs enable disease specificity, targeted selective activation of CD8+ T cells and a larger therapeutic window for IL-2 effectiveness. Neo-STAT is a plug-and-play variation of the Immuno-STAT platform designed with an empty “pocket” for the peptide presentation signal, enabling easy integration of disease-specific antigens a-posteriori to target a variety of cancers and infectious diseases. The modular Immuno-STAT framework is compatible with diverse co-modulators, including immuno-suppressive molecules, with potential to address a variety of autoimmune diseases. Cue Biopharma’s lead Immuno-STAT asset, CUE-101 has already shown encouraging results as a monotherapy in a Phase 1 dose escalation trial in late stage second line and beyond patients with HPV+ recurrent/metastatic head and neck cancer, which included a confirmed partial response with approximately 65% durable and ongoing tumor reduction and eight confirmed stable disease responses, controlling tumor growth for at least 12 weeks. The Company is preparing for an Investigational New Drug filing for their next Immuno-STAT clinical candidate, CUE-102, which targets Wilms Tumor 1 (WT1), expressed in numerous solid tumors and hematological cancers. Announcement • Sep 23
Cue Biopharma, Inc Grants U.S. Patents on Lead Clinical Program Novel Drug Product Candidate CUE-101 Cue Biopharma, Inc. announced the issuance of two new United States Patents Nos. 11,117,945 and 11,104,712 from the United States Patent and Trademark Office. U.S. Patent No. 11,117,945 covers Cue Biopharma’s first clinical drug candidate, CUE-101, and its use in treating HPV16-associated cancers such as head and neck, cervical, and genitoanal cancers. CUE-101 is currently in a Phase 1b clinical trial in which second line and beyond patients are receiving CUE-101 as a monotherapy for HPV16+ recurrent/metastatic head and neck squamous cell carcinoma (HNSCC). To date, CUE-101 has demonstrated monotherapy clinical activity by selective activation of targeted CD8+ T cells specific for HPV+ cancer cells with a 40% clinical benefit in the first 10 evaluable patients at the recommended Phase 2 dose of 4mg/kg. CUE-101 is also in a dose escalation study in combination with pembrolizumab in front-line patients with HPV16+ recurrent/metastatic HNSCC. A Phase 2 exploratory clinical trial in which CUE-101 will be administered in the neoadjuvant phase before standard of care (SOC) therapy in treatment-naïve, HLA-A*0201 positive patients with locally advanced, HPV-positive oropharyngeal squamous-cell carcinoma, is expected to begin enrolling patients this fall. The second U.S. Patent, No. 11,104,712, covers the use of CUE-101 in combination with KEYTRUDA® (pembrolizumab) for treating HPV16-associated cancers such as head and neck, cervical, and genitoanal cancers. The combination of CUE-101 and pembrolizumab is being evaluated by Cue Biopharma in collaboration with Merck Sharp & Dohme Corp. Reported Earnings • Aug 10
Second quarter 2021 earnings released: US$0.33 loss per share (vs US$0.38 loss in 2Q 2020) Second quarter 2021 results: Net loss: US$10.3m (loss narrowed 5.1% from 2Q 2020). Over the last 3 years on average, earnings per share has increased by 13% per year whereas the company’s share price has increased by 8% per year. Announcement • Jun 11
Cue Biopharma Announces First Patient Dosed in Part B Patient Expansion of CUE-101 Phase 1 Monotherapy Trial in HPV+ Second Line and Beyond HNSCC Cue Biopharma, Inc. announced that it has dosed the first patient in the Part B expansion phase of its Phase 1 monotherapy clinical trial of CUE-101 at the recommended Phase 2 dose of 4mg/kg. The Phase 1b portion of the CUE-101 monotherapy clinical trial in patients with HPV+ second line and beyond (2L+) head and neck squamous cell carcinoma (HNSCC) is expected to enroll up to 20 patients. The data supporting the patient expansion has been encouraging to date, with six patients having confirmed stable disease (SD) and one patient with a confirmed partial response of approximately 50% tumor reduction in the dose escalation Phase 1a portion of the CUE-101 monotherapy trial. The CUE-101 Clinical Trial: The trial (NCT03978689) is a multi-center, first-in-human, open-label Phase 1 dose escalation and expansion study evaluating the safety, anti-tumor effect and immunogenicity of CUE-101 as a monotherapy in second-line patients with confirmed HPV16-driven recurrent/metastatic HNSCC and HLA-A 02:01 serotype. Based on translational data from the Phase 1a portion of the trial, a recommended Phase 2 dose has been determined. The company has expanded the study to evaluate CUE-101 in combination with KEYTRUDA (pembrolizumab) as first-line treatment in patients with HPV16-driven recurrent/metastatic HNSCC. The CUE-100 Series: The CUE-100 series consists of Fc-fusion biologics that incorporate peptide-MHC (pMHC) molecules along with rationally engineered IL-2 molecules. This singular biologic is anticipated to selectively target, activate and expand a robust repertoire of tumor-specific T cells directly in the patient. The binding affinity of IL-2 for its receptor has been deliberately attenuated to achieve preferential selective activation of tumor-specific effector T cells while reducing the potential for effects on regulatory T cells (Tregs) or broad systemic activation, potentially mitigating the dose-limiting toxicities associated with current IL-2-based therapies. Immuno-STAT: The company’s Immuno-STAT (Selective Targeting and Alteration of T cells) biologics are designed for targeted modulation of disease-associated T cells in the areas of immuno-oncology and autoimmune disease. Each of biologic drugs is designed using proprietary scaffold comprising: 1) a pMHC to provide selectivity through interaction with the T cell receptor (TCR), and 2) a unique co-stimulatory signaling molecule to modulate the activity of the target T cells. The simultaneous engagement of co-regulatory molecules and pMHC binding mimics the signals delivered by antigen presenting cells (APCs) to T cells during a natural immune response. This design enables Immuno-STAT biologics to engage with the T cell population of interest, resulting in selective T cell modulation. Because its drug candidates are delivered directly in the patient’s body (in vivo), they are fundamentally different from other T cell therapeutic approaches that require the patients’ T cells to be extracted, modified outside the body (ex vivo), and reinfused. Announcement • May 27
Cue Biopharma to Present A Corporate and Clinical Progress Update At the Upcoming Jefferies Virtual Healthcare Conference Cue Biopharma, Inc. announced that it will present at the Jefferies Virtual Healthcare Conference being held June 1-4, 2021. Cue Biopharma will provide a corporate update highlighting clinical progress with CUE-101, representative of the CUE-100 series and the Company’s lead Immuno-STAT™ (Selective Targeting and Alteration of T cells) platform-based therapeutic, in clinical trials for the treatment of patients with HPV+ recurrent/metastatic head and neck cancer. The presentation will also focus on other platform developments as well as pipeline progress including CUE-102, Cue Biopharma’s drug candidate targeting Wilms Tumor 1 (WT1). CUE-102 is scheduled for an Investigational New Drug (IND) filing in 1H 2022. Reported Earnings • May 12
First quarter 2021 earnings released: US$0.41 loss per share (vs US$0.48 loss in 1Q 2020) First quarter 2021 results: Net loss: US$12.5m (loss narrowed 2.4% from 1Q 2020). Over the last 3 years on average, earnings per share has increased by 12% per year but the company’s share price has fallen by 8% per year, which means it is significantly lagging earnings. Announcement • May 11
Cue Biopharma Reports Confirms Partial Response in Ongoing Phase 1 Monotherapy Study of CUE-101 in Late Stage Second Line and Beyond Patients with HPV+ Recurrent/Metastatic Head and Neck Cancer Cue Biopharma, Inc. announced interim clinical data, including a confirmed partial response (PR), from its ongoing Phase 1a/1b monotherapy study of CUE-101 as second-line treatment for patients with HPV+ R/M HNSCC. To date, CUE-101 has demonstrated a favorable tolerability profile in a monotherapy dose escalation trial and continues to generate encouraging emerging data pertaining to its pharmacokinetic (PK) and pharmacodynamic (PD) profiles, as well as clinical anti-tumor activity. Key interim analysis of patient data from the ongoing open-label Phase 1a/1b study include: Confirmed PR in one patient and SD in five patients, all confirmed by RECIST criteria, in the dose escalation phase of the study to date, providing early signs of potential single-agent activity of CUE-101. Demonstrated evidence of both tumor-specific CD8+ T cell expansion as well as dose-dependent increases in NK cells in patients. Observed immune cell infiltration and tumor cell necrosis in patient tumor biopsies after CUE-101 treatment, supporting CUE-101’s mechanism of action at engaging and modulating targeted T cells within the patient’s body. Dose-proportional PK profile and comparable drug exposure levels in patients receiving repeated dosing cycles, consistent with a lack of drug-clearing anti-drug antibodies. No maximum tolerated dose (MTD) observed in patients dosed with up to 8 mg/kg of CUE-101. Announcement • Mar 17
Cue Biopharma, Inc. Announces Earnings Results for the Fourth Quarter and Full Year Ended December 31, 2020 Cue Biopharma, Inc. announced earnings results for the fourth quarter and full year ended December 31, 2020. For the quarter, the company reported operating loss of USD 10.974 million compared to USD 9.016 million a year ago. Net loss was USD 11.102 million compared to USD 8,918 million a year ago. Basic loss per share from continuing operations was USD 0.37 compared to USD 0.37 a year ago.
For the full year, operating loss was USD 45.042 million compared to USD 36.769 million a year ago. Net loss was USD 44.784 million compared to USD 36.698 million a year ago. Basic loss per share from continuing operations was USD 1.56 compared to USD 1.66 a year ago. Analyst Estimate Surprise Post Earnings • Mar 11
Revenue misses expectations Revenue missed analyst estimates by 18%. Over the next year, revenue is forecast to grow 156%, compared to a 57% growth forecast for the Biotechs industry in Germany. Reported Earnings • Mar 11
Full year 2020 earnings released: US$1.56 loss per share (vs US$1.67 loss in FY 2019) Full year 2020 results: Net loss: US$44.8m (loss widened 22% from FY 2019). Announcement • Feb 26
Cue Biopharma, Inc. Announces Executive Changes Cue Biopharma, Inc. announced the appointments of renowned experts AbulK. Abbas, M.D., distinguished professor in pathology and former chair of the department of pathology at the University of California, San Francisco (UCSF) and Michael Kalos, Ph.D., managing director of Next Pillar Consulting, LLC and former executive vice president and head of research and development at ArsenalBio, to its Scientific Advisory Board (SAB). Announcement • Feb 18
Cue Biopharma, Inc. Appoints Dr. Matteo Levisetti as Senior Vice President of Clinical Development, Effective February 22, 2021 Cue Biopharma, Inc. appointed Dr. Matteo Levisetti as senior vice president of clinical development, effective February 22, 2021. Dr. Levisetti joins Cue Biopharma with extensive drug development experience in the pharmaceutical and biotech industries, where he led global clinical development and regulatory strategies for multiple clinical development programs in immuno-oncology, and autoimmune and inflammatory diseases. Announcement • Feb 09
Cue Biopharma Initiates Patient Dosing in Phase 1 Study of CUE-101 in Combination with KEYTRUDA Cue Biopharma, Inc. announced that on February 1, 2021, the first patient was dosed in a Phase 1 dose escalation clinical trial of CUE-101 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab). CUE-101 is being evaluated in combination with KEYTRUDA® as first-line treatment for human papilloma virus positive recurrent/metastatic head and neck squamous cell carcinoma (HPV+ R/M HNSCC). This Phase 1 dose escalation combination trial (NCT03978689) is being conducted in parallel at the same clinics that are conducting the ongoing Phase 1 monotherapy study of CUE-101. Due to the tolerability profile demonstrated to date in the CUE-101 monotherapy dose escalation trial, the first dose in the combination arm is 1 mg/kg every three weeks (Q3W), which is also the recommended dosing interval for KEYTRUDA. Is New 90 Day High Low • Dec 31
New 90-day low: €9.95 The company is down 23% from its price of €13.00 on 02 October 2020. The German market is up 9.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 6.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is €102 per share. Recent Insider Transactions • Nov 26
Independent Director recently bought €70k worth of stock On the 24th of November, Aaron Fletcher bought around 7k shares on-market at roughly €10.64 per share. In the last 3 months, there was an even bigger purchase from another insider worth €129k. Despite this recent purchase, insiders have collectively sold €916k more in shares than they bought in the last 12 months. Is New 90 Day High Low • Nov 20
New 90-day low: €10.80 The company is down 35% from its price of €16.60 on 21 August 2020. The German market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Biotechs industry, which is down 10.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Announcement • Nov 10
Cue Biopharma Announces Presentations Highlighting Clinical Progress of CUE-101, Pipeline Progress of CUE-100 Series Immuno-STATs and Immuno-STAT Data for Infectious Disease Applications at the Society for Immunotherapy of Cancer’s (SITC) 35th Anniversary Annual Meeting Cue Biopharma, Inc. announced three poster presentations highlighting the Company’s clinical and pipeline progress at the Society for Immunotherapy of Cancer's 35th Anniversary Annual Meeting (SITC 2020). The posters include a clinical update on CUE-101, the lead drug candidate from the IL-2 based CUE-100 series, and data supporting the potential of the Immuno-STAT™ (Selective Targeting and Alteration of T cells) platform to selectively engage and modulate targeted T cells within the body in a manner that can address a broad range of indications. Due to the abstract submission and acceptance dates for SITC, the poster highlighting progress on CUE-101 will only contain data updates through cohort 4. Members of the Cue Biopharma executive management team will provide further updates and details pertaining to patients from cohorts 4, 5 and 6 at the upcoming quarterly update call on November 17 at 4:30 p.m. EST. In addition, Cue Biopharma has recently received permission from the Clinical Safety and Review Committee to proceed with dose escalation to cohort 7 at 8 mg/kg. Recent Insider Transactions • Oct 02
Independent Director recently bought €129k worth of stock On the 30th of September, Cameron Gray bought around 10k shares on-market at roughly €12.90 per share. This was the largest purchase by an insider in the last 3 months. Despite this recent purchase, insiders have collectively sold €986k more in shares than they bought in the last 12 months. 
