Reported Earnings • May 17
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 the US are expected to grow by 22%. 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 43% per year, which means it is significantly lagging earnings. Aankondiging • 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. Aankondiging • 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. Board Change • Mar 30
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 5 experienced directors. 2 highly experienced 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. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Breakeven Date Change • Mar 18
No longer forecast to breakeven The analyst covering Cue Biopharma no longer expects the company to break even during the foreseeable future. The company was expected to make a profit of US$24.9m in 2028. New forecast suggests the company will make a loss of US$55.0m in 2028. Aankondiging • 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. Aankondiging • Feb 19
Cue Biopharma, Inc., Annual General Meeting, Apr 13, 2026 Cue Biopharma, Inc., Annual General Meeting, Apr 13, 2026. Aankondiging • 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. New Risk • Feb 09
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 10% 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 (19% average weekly change). Earnings are forecast to decline by an average of 10% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (44% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$54m net loss in 3 years). Market cap is less than US$100m (US$29.2m market cap). Recent Insider Transactions • Jan 04
Independent Chairman of the Board recently bought US$100k worth of stock On the 30th of December, Pasha Sarraf bought around 324k shares on-market at roughly US$0.31 per share. This trade did not impact their existing holding. This was the largest purchase by an insider in the last 3 months. This was Pasha's only on-market trade for the last 12 months. New Risk • Jan 02
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 44% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (17% average weekly change). Shareholders have been substantially diluted in the past year (44% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$23m net loss in 3 years). Market cap is less than US$100m (US$27.9m market cap). New Risk • Dec 18
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 11% a week. This is considered a minor risk. Share price volatility indicates 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. It also 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. Currently, the following risks have been identified for the company: Major Risk Less than 1 year of cash runway based on free cash flow trend (-US$30m free cash flow). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$23m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). Shareholders have been diluted in the past year (24% increase in shares outstanding). Market cap is less than US$100m (US$31.5m market cap). Price Target Changed • Nov 29
Price target increased by 19% to US$5.00 Up from US$4.20, the current price target is an average from 2 analysts. New target price is 694% above last closing price of US$0.63. Stock is down 48% over the past year. The company is forecast to post a net loss per share of US$0.41 next year compared to a net loss per share of US$0.72 last year. Major Estimate Revision • Nov 19
Consensus revenue estimates increase by 43% The consensus outlook for revenues in fiscal year 2025 has improved. 2025 revenue forecast increased from US$7.38m to US$10.5m. Forecast losses expected to reduce from -US$0.43 to -US$0.37 per share. Biotechs industry in the US expected to see average net income decline 7.4% next year. Consensus price target of US$4.00 unchanged from last update. Share price fell 13% to US$0.58 over the past week. New Risk • Nov 17
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 12% 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 Less than 1 year of cash runway based on free cash flow trend (-US$30m free cash flow). Earnings are forecast to decline by an average of 12% per year for the foreseeable future. Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$54m net loss in 3 years). Shareholders have been diluted in the past year (21% increase in shares outstanding). Market cap is less than US$100m (US$48.4m market cap). Reported Earnings • Nov 14
Third quarter 2025 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2025 results: US$0.074 loss per share (improved from US$0.17 loss in 3Q 2024). Revenue: US$2.15m (down 36% from 3Q 2024). Net loss: US$7.45m (loss narrowed 14% from 3Q 2024). Revenue missed analyst estimates by 6.1%. Earnings per share (EPS) exceeded analyst estimates by 25%. Revenue is forecast to grow 69% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 34% per year but the company’s share price has fallen by 42% per year, which means it is significantly lagging earnings. Major Estimate Revision • Aug 26
Consensus revenue estimates decrease by 12%, EPS upgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from US$8.40m to US$7.38m. EPS estimate increased from -US$0.45 to -US$0.43 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target of US$4.00 unchanged from last update. Share price rose 2.9% to US$0.84 over the past week. Aankondiging • 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. Reported Earnings • Aug 13
Second quarter 2025 earnings: EPS and revenues exceed analyst expectations Second quarter 2025 results: US$0.089 loss per share (improved from US$0.20 loss in 2Q 2024). Revenue: US$2.95m (up 11% from 2Q 2024). Net loss: US$8.48m (loss narrowed 17% from 2Q 2024). Revenue exceeded analyst estimates by 48%. Earnings per share (EPS) also surpassed analyst estimates by 31%. Over the last 3 years on average, earnings per share has increased by 29% per year but the company’s share price has fallen by 36% per year, which means it is significantly lagging earnings. Aankondiging • 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®?). Board Change • Jul 15
High number of new and inexperienced directors There are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 3 experienced directors. 3 highly experienced 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. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Aankondiging • 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. Aankondiging • 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. New Risk • Jun 18
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 12% a week. This is considered a minor risk. Share price volatility indicates 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. It also 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. Currently, the following risks have been identified for the company: Major Risk Shareholders have been substantially diluted in the past year (55% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$27m net loss in 3 years). Share price has been volatile over the past 3 months (12% average weekly change). Market cap is less than US$100m (US$43.7m market cap). Major Estimate Revision • May 20
Consensus revenue estimates decrease by 19%, EPS upgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from US$6.62m to US$5.38m. EPS estimate increased from -US$0.573 to -US$0.55 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target of US$3.33 unchanged from last update. Share price fell 13% to US$0.67 over the past week. Reported Earnings • May 14
First quarter 2025 earnings: EPS and revenues miss analyst expectations First quarter 2025 results: US$0.17 loss per share (improved from US$0.25 loss in 1Q 2024). Revenue: US$421.0k (down 76% from 1Q 2024). Net loss: US$12.3m (flat on 1Q 2024). Revenue missed analyst estimates by 67%. Earnings per share (EPS) also missed analyst estimates by 11%. Revenue is forecast to grow 59% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 24% per year but the company’s share price has fallen by 40% per year, which means it is significantly lagging earnings. New Risk • Apr 23
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 55% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risk Shareholders have been substantially diluted in the past year (55% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$54m net loss in 3 years). Market cap is less than US$100m (US$59.0m market cap). Major Estimate Revision • Apr 16
Consensus EPS estimates fall by 18% The consensus outlook for fiscal year 2025 has been updated. 2025 expected loss increased from -US$0.493 to -US$0.583 per share. Revenue forecast of US$6.62m unchanged since last update. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target of US$3.50 unchanged from last update. Share price rose 11% to US$0.78 over the past week. Aankondiging • 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 Major Estimate Revision • Apr 07
Consensus revenue estimates decrease by 37%, EPS upgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast fell from US$10.5m to US$6.62m. EPS estimate increased from -US$0.55 to -US$0.493 per share. Biotechs industry in the US expected to see average net income decline 12% next year. Consensus price target of US$3.50 unchanged from last update. Share price fell 26% to US$0.68 over the past week. Reported Earnings • Apr 01
Full year 2024 earnings: EPS exceeds analyst expectations while revenues lag behind Full year 2024 results: US$0.72 loss per share (improved from US$1.11 loss in FY 2023). Revenue: US$9.29m (up 69% from FY 2023). Net loss: US$40.7m (loss narrowed 20% from FY 2023). Revenue missed analyst estimates by 1.3%. Earnings per share (EPS) exceeded analyst estimates by 5.5%. Revenue is forecast to grow 25% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 20% per year but the company’s share price has fallen by 49% per year, which means it is significantly lagging earnings. Aankondiging • 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. New Risk • Jan 16
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 40% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. 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$38m free cash flow). Share price has been highly volatile over the past 3 months (22% average weekly change). Earnings are forecast to decline by an average of 7.2% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (40% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$47m net loss in 3 years). Market cap is less than US$100m (US$77.3m market cap). Reported Earnings • Nov 17
Third quarter 2024 earnings: EPS and revenues exceed analyst expectations 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 exceeded analyst estimates by 120%. Earnings per share (EPS) also surpassed analyst estimates by 12%. Revenue is forecast to grow 35% p.a. on average during the next 3 years, compared to a 22% growth forecast for the Biotechs industry in the US. 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 56% per year, which means it is significantly lagging earnings. Aankondiging • 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. Aankondiging • 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. Aankondiging • 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 New Risk • Sep 28
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 American stocks, typically moving 20% 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 Risk Share price has been highly volatile over the past 3 months (20% average weekly change). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$40m 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 (US$22.1m market cap). Aankondiging • 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 Aankondiging • 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. Major Estimate Revision • Aug 21
Consensus estimates of losses per share improve by 20% The consensus outlook for earnings per share (EPS) in fiscal year 2024 has improved. 2024 revenue forecast increased from US$10.5m to US$11.1m. EPS estimate increased from -US$0.948 per share to -US$0.76 per share. Biotechs industry in the US expected to see average net income decline 14% next year. Consensus price target down from US$5.00 to US$4.20. Share price rose 46% to US$0.91 over the past week. Aankondiging • 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. Reported Earnings • Aug 16
Second quarter 2024 earnings: EPS and revenues exceed analyst expectations 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 exceeded analyst estimates by 106%. Earnings per share (EPS) also surpassed analyst estimates by 26%. Revenue is forecast to grow 62% p.a. on average during the next 3 years, compared to a 23% growth forecast for the Biotechs industry in the US. 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. Price Target Changed • Jul 27
Price target decreased by 15% to US$8.00 Down from US$9.40, the current price target is an average from 3 analysts. New target price is 1,094% above last closing price of US$0.67. Stock is down 83% over the past year. The company is forecast to post a net loss per share of US$0.95 next year compared to a net loss per share of US$1.11 last year. Aankondiging • 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. Major Estimate Revision • May 17
Consensus revenue estimates increase by 17% The consensus outlook for revenues in fiscal year 2024 has improved. 2024 revenue forecast increased from US$9.01m to US$10.5m. Forecast losses expected to reduce from -US$1.03 to -US$1.00 per share. Biotechs industry in the US expected to see average net income decline 9.9% next year. Consensus price target of US$9.40 unchanged from last update. Share price was steady at US$1.71 over the past week. Reported Earnings • May 10
First quarter 2024 earnings: EPS and revenues exceed analyst expectations 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 exceeded analyst estimates by 42%. Earnings per share (EPS) also surpassed analyst estimates by 11%. 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 the US. 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. Aankondiging • 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 Risk 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). Share price has been volatile over the past 3 months (12% average weekly change). Shareholders have been diluted in the past year (13% increase in shares outstanding). Market cap is less than US$100m (US$92.4m market cap). Major Estimate Revision • Apr 04
Consensus EPS estimates fall by 20% The consensus outlook for fiscal year 2024 has been updated. 2024 expected loss increased from -US$1.11 to -US$1.33 per share. Revenue forecast of US$9.18m unchanged since last update. Biotechs industry in the US expected to see average net income decline 9.6% next year. Consensus price target of US$9.40 unchanged from last update. Share price fell 5.8% to US$1.78 over the past week. Reported Earnings • Apr 01
Full year 2023 earnings: EPS and revenues exceed analyst expectations 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 exceeded analyst estimates by 14%. Earnings per share (EPS) also surpassed analyst estimates by 3.0%. 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 the US. 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 47% 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 Risk 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). Share price has been volatile over the past 3 months (13% average weekly change). 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 (US$79.9m market cap). New Risk • Feb 18
New minor risk - Market cap size The company's market capitalization is less than US$100m. Market cap: 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: Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$57m net loss in 3 years). Share price has been volatile over the past 3 months (11% average weekly change). 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 (US$98.8m market cap). Major Estimate Revision • Nov 10
Consensus revenue estimates decrease by 25% The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$3.81m to US$2.85m. EPS estimate unchanged at -US$1.28 per share. Biotechs industry in the US expected to see average net income growth of 1.4% next year. Consensus price target up from US$10.00 to US$10.25. Share price fell 6.5% to US$2.08 over the past week. Reported Earnings • Nov 05
Third quarter 2023 earnings: EPS and revenues exceed analyst expectations Third quarter 2023 results: US$0.24 loss per share. Net loss: US$11.0m (flat on 3Q 2022). Revenue exceeded analyst estimates by 87%. Earnings per share (EPS) also surpassed analyst estimates by 30%. 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 the US. Aankondiging • 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 03
New minor risk - Share price stability The company's share price has been volatile over the past 3 months. It is more volatile than 75% of American stocks, typically moving 9.2% a week. This is considered a minor risk. Share price volatility indicates 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. It also 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. Currently, the following risks have been identified for the company: Major Risk 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). Share price has been volatile over the past 3 months (9.2% average weekly change). Shareholders have been diluted in the past year (27% increase in shares outstanding). Revenue is less than US$5m (US$1.8m revenue). Aankondiging • 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. Aankondiging • 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. Reported Earnings • Aug 09
Second quarter 2023 earnings: EPS and revenues exceed analyst expectations 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 exceeded analyst estimates by 52%. Earnings per share (EPS) also surpassed analyst estimates by 4.9%. Revenue is forecast to grow 59% p.a. on average during the next 3 years, compared to a 15% growth forecast for the Biotechs industry in the US. 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 44% per year, which means it is significantly lagging earnings. Aankondiging • 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%. Major Estimate Revision • May 17
Consensus revenue estimates decrease by 91%, EPS upgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from US$2.17m to US$190.0k. EPS estimate increased from -US$1.40 to -US$1.38 per share. Biotechs industry in the US expected to see average net income decline 85% next year. Consensus price target of US$10.00 unchanged from last update. Share price fell 12% to US$4.25 over the past week. Aankondiging • 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 11
First quarter 2023 earnings: EPS in line with expectations, revenues disappoint 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 18% growth forecast for the Biotechs industry in the US. 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 42% per year, which means it is significantly lagging earnings. Major Estimate Revision • Mar 28
Consensus revenue estimates fall by 24% The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from US$2.86m to US$2.17m. Forecast losses increased from -US$1.27 to -US$1.40 per share. Biotechs industry in the US expected to see average net income decline 50% next year. Consensus price target down from US$10.25 to US$10.00. Share price was steady at US$3.12 over the past week. Reported Earnings • Mar 23
Full year 2022 earnings: Revenues exceed analysts expectations while EPS lags behind 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). Products in clinical trials Phase I: 4 Revenue exceeded analyst estimates by 4.0%. Earnings per share (EPS) missed analyst estimates by 4.7%. Revenue is forecast to grow 60% p.a. on average during the next 3 years, compared to a 13% growth forecast for the Biotechs industry in the US. 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 38% per year, which means it is significantly lagging earnings. Aankondiging • 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. Aankondiging • 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. Major Estimate Revision • Nov 21
Consensus forecasts updated The consensus outlook for 2022 has been updated. 2022 revenue forecast fell from US$6.07m to US$1.19m. EPS estimate increased from -US$1.51 to -US$1.44 per share. Biotechs industry in the US expected to see average net income decline 94% next year. Consensus price target up from US$11.67 to US$13.80. Share price fell 3.7% to US$3.13 over the past week. Reported Earnings • Nov 16
Third quarter 2022 earnings: EPS exceeds analyst expectations while revenues lag behind Third quarter 2022 results: US$0.31 loss per share (improved from US$0.41 loss in 3Q 2021). Revenue: US$68.0k (down 97% from 3Q 2021). Net loss: US$11.0m (loss narrowed 16% from 3Q 2021). Revenue missed analyst estimates by 85%. Earnings per share (EPS) exceeded analyst estimates by 19%. Revenue is forecast to grow 66% p.a. on average during the next 3 years, compared to a 14% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 7% per year but the company’s share price has fallen by 27% per year, which means it is significantly lagging earnings. Major Estimate Revision • Aug 25
Consensus revenue estimates fall by 50% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from US$14.1m to US$7.06m. Forecast losses increased from -US$1.29 to -US$1.51 per share. Biotechs industry in the US expected to see average net income decline 57% next year. Consensus price target down from US$20.25 to US$16.25. Share price fell 4.8% to US$2.96 over the past week.