View Future GrowthCue Biopharma 과거 순이익 실적과거 기준 점검 0/6Cue Biopharma은 연평균 7.3%의 비율로 수입이 증가해 온 반면, Biotechs 산업은 연평균 33.8%의 비율로 증가했습니다. 매출은 연평균 23.7%의 비율로 증가했습니다.핵심 정보7.31%순이익 성장률25.11%주당순이익(EPS) 성장률Biotechs 산업 성장률17.04%매출 성장률23.70%자기자본이익률-90.35%순이익률-59.65%최근 순이익 업데이트31 Mar 2026최근 과거 실적 업데이트Reported Earnings • May 17First 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.Reported Earnings • Nov 14Third quarter 2025 earnings: EPS exceeds analyst expectations while revenues lag behindThird 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.Reported Earnings • Aug 13Second quarter 2025 earnings: EPS and revenues exceed analyst expectationsSecond 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.Reported Earnings • May 14First quarter 2025 earnings: EPS and revenues miss analyst expectationsFirst 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.Reported Earnings • Apr 01Full year 2024 earnings: EPS exceeds analyst expectations while revenues lag behindFull 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.Reported Earnings • Nov 17Third quarter 2024 earnings: EPS and revenues exceed analyst expectationsThird 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.모든 업데이트 보기Recent updatesReported Earnings • May 17First 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.공시 • May 15Cue Biopharma, Inc. announced that it has received $29.999992 million in fundingOn May 14, 2026, Cue Biopharma, Inc. closed the transaction. The net proceeds after deducting placement agent fees and offering expenses is $28,000,000.공시 • May 02Cue Biopharma, Inc. announced that it expects to receive $29.999992 million in fundingCue 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 30High number of new and inexperienced directorsThere 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.공시 • Mar 28+ 1 more updateCue Biopharma, Inc. Announces Chief Executive Officer ChangesOn March 26, 2026, the Board of Directors of Cue Biopharma, Inc. appointed Lucinda Warren, the Chief Financial and Business Officer of the Company, as Interim Chief Executive Officer, effective as of March 27, 2026. Ms. Warren will also continue to serve as the Chief Financial and Business Officer. Ms. Warren will succeed Usman Azam whose resignation as Chief Executive Officer effective as of March 26, 2026. Ms. Warren, age 57, has served as the Company's Chief Financial and Business Officer since February 2026 and previously served as the Company's Chief Business Officer from September 2024 until February 2026. She has over 30 years of global experience in the pharmaceutical and biotechnology sectors. Prior to joining the Company, Ms. Warren was at Johnson & Johnson, a healthcare products company, from 1999 to 2024, where she held roles of increasing responsibility in end-to-end business development, including licensing, mergers and acquisitions, and alliance management, most recently as vice president of business development for Neuroscience and Japan Regionally. Ms. Warren previously held significant roles at Janssen Cilag Australia and Janssen Biologics, where she led business units and managed global transitions. She currently serves as chairman of the board of International School Services. Ms. Warren holds a B.S. in biological sciences with a minor in neurology from the University of Alberta.Breakeven Date Change • Mar 18No longer forecast to breakevenThe 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.공시 • Mar 10Cue Biopharma Inc Presents New in Vitro Data for Cue-401 At World Immune Regulation MeetingCue 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.공시 • Feb 19Cue Biopharma, Inc., Annual General Meeting, Apr 13, 2026Cue Biopharma, Inc., Annual General Meeting, Apr 13, 2026.공시 • Feb 18Cue Biopharma Inc Announces Preclinical Safety and Tolerability Data for CUE-401 for the Treatment of Autoimmune and Inflammatory DiseasesCue 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.공시 • Feb 12+ 1 more updateCue Biopharma, Inc. Appoints Lucinda Warren as Chief Business Officer, Effective September 2024Cue Biopharma, Inc. appointed Lucinda Warren as Chief Business Officer of the Company in September 2024. Ms. Warren, age 57, has over 30 years of global experience in the pharmaceutical and biotechnology sectors. Prior to joining the Company, she served as vice president of business development for Neuroscience and Japan regionally at Johnson & Johnson, a healthcare products company, from 2014 to 2024, where she was responsible for end-to-end business development, including licensing, mergers and acquisitions, and alliance management. Ms. Warren previously held significant roles at Janssen Cilag Australia and Janssen Biologics, where she led business units and managed global transitions. She currently serves as chairman of the board of International School Services. Ms. Warren holds a B.S. in biological sciences with a minor in neurology from the University of Alberta.New Risk • Feb 09New major risk - Revenue and earnings growthEarnings 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 04Independent Chairman of the Board recently bought US$100k worth of stockOn 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 02New major risk - Shareholder dilutionThe 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).공시 • Dec 19+ 1 more updateCue Biopharma, Inc. has completed a Follow-on Equity Offering in the amount of $14.982143 million.Cue Biopharma, Inc. has completed a Follow-on Equity Offering in the amount of $14.982143 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 35,714,286 Price\Range: $0.28 Discount Per Security: $0.0168 Security Name: Pre-Funded Warrants Security Type: Equity Warrant Securities Offered: 17,857,143 Price\Range: $0.279 Discount Per Security: $0.0168New Risk • Dec 18New minor risk - Share price stabilityThe 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 29Price target increased by 19% to US$5.00Up 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 19Consensus 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 17New major risk - Revenue and earnings growthEarnings 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 14Third quarter 2025 earnings: EPS exceeds analyst expectations while revenues lag behindThird 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.분석 기사 • Oct 09Is Cue Biopharma (NASDAQ:CUE) Using Debt In A Risky Way?Warren Buffett famously said, 'Volatility is far from synonymous with risk.' It's only natural to consider a company's...공시 • Sep 29+ 1 more updateCue Biopharma, Inc. Announces Chief Executive Officer Changes, Effective September 29, 2025Cue Biopharma, Inc. announced that Usman “Oz” Azam, M.D., has been appointed Chief Executive Officer (CEO) of Cue Biopharma, effective September 29, 2025. Daniel Passeri will transition from his current role as CEO to one of Strategic Advisor, effective as of the same date. Dr. Azam brings over 25 years of drug discovery and development leadership as well as operating expertise to Cue Biopharma. Most recently, Dr. Azam served as CEO of Inspirna, Inc., a privately held clinical stage biopharmaceutical company focused on the discovery and development of novel cancer drugs. Prior to Inspirna, Dr. Azam served as CEO of Empyrean Neuroscience, a genetic engineering company, advancing a pipeline of neuroactive compounds targeting disorders of the central nervous system. As President and CEO of Tmunity Therapeutics, he was involved in developing genetically engineered CAR-T cell therapies for solid tumor applications in cancer. He served as Global Head of the Cell and Gene Therapies unit at Novartis where he helped deliver and launch the first-ever FDA approval for a CAR-T cell therapy in hematologic cancers. Dr. Azam is well-respected in the industry for his extensive experience in leadership roles across both innovative biotechnology and large pharmaceutical companies, namely Pfizer Pharmaceuticals, Aspreva Pharmaceuticals, Johnson & Johnson, and GlaxoSmithKline (GSK). The learnings across these roles and his in-depth experience with T cell therapeutics make him well-suited to foster the Company’s next stage of growth.Major Estimate Revision • Aug 26Consensus revenue estimates decrease by 12%, EPS upgradedThe 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.공시 • Aug 16Cue Biopharma Announces Initiation of Investigator Sponsored Trial of Cue-102 in Recurrent Glioblastoma MultiformeCue 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 13Second quarter 2025 earnings: EPS and revenues exceed analyst expectationsSecond 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.공시 • Jul 17Cue 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 CancerCue 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 15High number of new and inexperienced directorsThere 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.공시 • Jul 02Cue Biopharma, Inc. Provides Update on Most Advanced Clinical Stage Asset, CUE-101 at the DAVA 4th Hawaii Global Summit on Thoracic MalignanciesCue 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.공시 • Jun 25Cue 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 DiseaseCue 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 18New minor risk - Share price stabilityThe 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).공시 • Jun 11+ 1 more updateCue Biopharma, Inc. Announces Management ChangesCue Biopharma, Inc. announced that On June 4, 2025, Jill Broadfoot was appointed to the board of directors of the company, the Audit Committee of the Board, and the Corporate Governance and Nominating Committee of the Board, following the recommendation of the Corporate Governance and Nominating Committee of the Board. Ms. Broadfoot will serve as the Chair of the Audit Committee of the Board. The company also announced that Effective June 13, 2025, Daniel R. Passeri, the Company’s Chief Executive Officer, will serve as the Company’s principal financial and accounting officer on an interim basis until a new principal financial and accounting officer is designated due to resignation of Kerri-Ann Millar as Chief Financial Officer, effective June 13, 2025.Major Estimate Revision • May 20Consensus revenue estimates decrease by 19%, EPS upgradedThe 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 14First quarter 2025 earnings: EPS and revenues miss analyst expectationsFirst 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 23New major risk - Shareholder dilutionThe 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 16Consensus 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.공시 • Apr 16Cue 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: 6,249,999공시 • Apr 15+ 1 more updateCue Biopharma, Inc., Annual General Meeting, Jun 04, 2025Cue Biopharma, Inc., Annual General Meeting, Jun 04, 2025.Major Estimate Revision • Apr 07Consensus revenue estimates decrease by 37%, EPS upgradedThe 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 01Full year 2024 earnings: EPS exceeds analyst expectations while revenues lag behindFull 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.공시 • Mar 13Cue Biopharma, Inc. Appoints Pasha Sarraf as Board of DirectorsCue 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 16New major risk - Shareholder dilutionThe 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 17Third quarter 2024 earnings: EPS and revenues exceed analyst expectationsThird 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.공시 • Nov 15Cue Biopharma Announces Strategic Organizational TransitionCue 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.공시 • Nov 09Cue 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 MeetingCue 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.공시 • Sep 28Cue 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: $0.02994New Risk • Sep 28New major risk - Share price stabilityThe 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).공시 • Sep 27Cue 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 Warrant공시 • Sep 11Cue Biopharma, Inc. Appoints Lucinda Warren as Chief Business OfficerCue 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 21Consensus 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.공시 • Aug 18Cue Biopharma Receives Non-Compliance Letter from Nasdaq Regarding Minimum Bid Price RequirementOn 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 16Second quarter 2024 earnings: EPS and revenues exceed analyst expectationsSecond 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 27Price target decreased by 15% to US$8.00Down 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.공시 • Jul 03+ 2 more updatesCue Biopharma, Inc.(NasdaqCM:CUE) dropped from Russell Small Cap Completeness IndexCue Biopharma, Inc.(NasdaqCM:CUE) dropped from Russell Small Cap Completeness Index공시 • Jun 10Cue Biopharma, Inc. Appoints Michael J. Fox to the Board of Directors and the Compensation CommitteeOn 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 17Consensus 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 10First quarter 2024 earnings: EPS and revenues exceed analyst expectationsFirst 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.공시 • Apr 28Cue Biopharma, Inc., Annual General Meeting, Jun 05, 2024Cue 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.분석 기사 • Apr 16Here's Why Cue Biopharma (NASDAQ:CUE) Can Manage Its Debt Despite Losing MoneyDavid Iben put it well when he said, 'Volatility is not a risk we care about. What we care about is avoiding the...New Risk • Apr 10New major risk - Revenue and earnings growthEarnings 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 04Consensus 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 01Full year 2023 earnings: EPS and revenues exceed analyst expectationsFull 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 13New major risk - Revenue and earnings growthEarnings 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 18New minor risk - Market cap sizeThe 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).분석 기사 • Dec 30Does Cue Biopharma (NASDAQ:CUE) Have A Healthy Balance Sheet?Warren Buffett famously said, 'Volatility is far from synonymous with risk.' So it seems the smart money knows that...Major Estimate Revision • Nov 10Consensus 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 05Third quarter 2023 earnings: EPS and revenues exceed analyst expectationsThird 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.공시 • Nov 04Cue 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 2023Cue 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 03New minor risk - Share price stabilityThe 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).공시 • Sep 27Cue 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.공시 • Sep 15Cue Biopharma, Inc. Announces Resignation of Aaron Fletcher as Member of the Board of Directors, Effective October 9, 2023On 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.분석 기사 • Aug 11Is Cue Biopharma (NASDAQ:CUE) Using Too Much Debt?David Iben put it well when he said, 'Volatility is not a risk we care about. What we care about is avoiding the...Reported Earnings • Aug 09Second quarter 2023 earnings: EPS and revenues exceed analyst expectationsSecond 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.공시 • May 26Cue 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 MeetingCue 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 17Consensus revenue estimates decrease by 91%, EPS upgradedThe 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.공시 • May 11Cue 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 OfferingReported Earnings • May 11First quarter 2023 earnings: EPS in line with expectations, revenues disappointFirst 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 28Consensus 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 23Full year 2022 earnings: Revenues exceed analysts expectations while EPS lags behindFull 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.공시 • Feb 17Cue Biopharma, Inc. Announces the Appointment of Rafi Ahmed to its Scientific Advisory BoardCue 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.공시 • Jan 24Cue Biopharma, Inc. Announces Executive ChangesCue 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 21Consensus forecasts updatedThe 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 16Third quarter 2022 earnings: EPS exceeds analyst expectations while revenues lag behindThird 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.Seeking Alpha • Oct 04Cue Biopharma shares rise ~10% on FDA fast track nod for head and neck cancer drugCue Biopharma (NASDAQ:CUE) on Tuesday said it had got a fast track designation from the U.S. FDA for its drug candidate CUE-101 for the treatment of head and neck cancer associated with human papilloma virus. CUE stock jumped 9.6% to $2.62 in early trading. The designation was for CUE-101 as a monotherapy and in combination with Merck's (MRK) Keytruda for the treatment of human papilloma virus recurrent/metastatic head and neck squamous cell carcinoma. The FDA's Fast Track approval is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. "To date in its Phase 1b clinical trials, CUE-101 has demonstrated a favorable tolerability profile and single-agent anti-tumor activity in monotherapy as well as encouraging anti-tumor clinical activity in combination with (Keytruda)," CUE senior vice president of clinical development Matteo Levisetti said in a statement.분석 기사 • Sep 23Despite Lacking Profits Cue Biopharma (NASDAQ:CUE) Seems To Be On Top Of Its DebtLegendary fund manager Li Lu (who Charlie Munger backed) once said, 'The biggest investment risk is not the volatility...분석 기사 • Aug 26News Flash: 4 Analysts Think Cue Biopharma, Inc. (NASDAQ:CUE) Earnings Are Under ThreatThe analysts covering Cue Biopharma, Inc. ( NASDAQ:CUE ) delivered a dose of negativity to shareholders today, by...Major Estimate Revision • Aug 25Consensus 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.매출 및 비용 세부 내역Cue Biopharma가 돈을 벌고 사용하는 방법. 최근 발표된 LTM 실적 기준.순이익 및 매출 추이NasdaqCM:CUE 매출, 비용 및 순이익 (USD Millions)날짜매출순이익일반관리비연구개발비31 Mar 2633-2019-231 Dec 2527-2719030 Sep 257-3817-730 Jun 258-3915031 Mar 258-4115031 Dec 249-4118030 Sep 2410-45152430 Jun 248-4716031 Mar 247-5018031 Dec 235-5117030 Sep 234-5222030 Jun 232-5219031 Mar 230-5218031 Dec 221-5319030 Sep 229-4717030 Jun 2212-4918031 Mar 2214-4618031 Dec 2115-4417030 Sep 217-4716030 Jun 215-4415031 Mar 214-4415031 Dec 203-4515030 Sep 204-4314030 Jun 204-4014031 Mar 204-3813031 Dec 193-3713030 Sep 193-3914030 Jun 192-4514031 Mar 192-4313031 Dec 181-3911030 Sep 181-388030 Jun 180-306031 Mar 180-275-231 Dec 170-234030 Sep 170-164230 Jun 170-134331 Mar 170-104631 Dec 160-835양질의 수익: CUE 은(는) 현재 수익성이 없습니다.이익 마진 증가: CUE는 현재 수익성이 없습니다.잉여현금흐름 대비 순이익 분석과거 순이익 성장 분석수익추이: CUE는 수익성이 없지만 지난 5년 동안 연평균 7.3%의 속도로 손실을 줄였습니다.성장 가속화: 현재 수익성이 없어 지난 1년간 CUE의 수익 성장률을 5년 평균과 비교할 수 없습니다.수익 대 산업: CUE은 수익성이 없어 지난 해 수익 성장률을 Biotechs 업계(43%)와 비교하기 어렵습니다.자기자본이익률높은 ROE: CUE는 현재 수익성이 없으므로 자본 수익률이 음수(-90.35%)입니다.총자산이익률투하자본수익률우수한 과거 실적 기업을 찾아보세요7D1Y7D1Y7D1YPharmaceuticals-biotech 산업에서 과거 실적이 우수한 기업.View Financial Health기업 분석 및 재무 데이터 상태데이터최종 업데이트 (UTC 시간)기업 분석2026/05/22 11:59종가2026/05/22 00:00수익2026/03/31연간 수익2025/12/31데이터 소스당사의 기업 분석에 사용되는 데이터는 S&P Global Market Intelligence LLC에서 제공됩니다. 아래 데이터는 이 보고서를 생성하기 위해 분석 모델에서 사용됩니다. 데이터는 정규화되므로 소스가 제공된 후 지연이 발생할 수 있습니다.패키지데이터기간미국 소스 예시 *기업 재무제표10년손익계산서현금흐름표대차대조표SEC 양식 10-KSEC 양식 10-Q분석가 컨센서스 추정치+3년재무 예측분석가 목표주가분석가 리서치 보고서Blue Matrix시장 가격30년주가배당, 분할 및 기타 조치ICE 시장 데이터SEC 양식 S-1지분 구조10년주요 주주내부자 거래SEC 양식 4SEC 양식 13D경영진10년리더십 팀이사회SEC 양식 10-KSEC 양식 DEF 14A주요 개발10년회사 공시SEC 양식 8-K* 미국 증권에 대한 예시이며, 비(非)미국 증권에는 해당 국가의 규제 서식 및 자료원을 사용합니다.별도로 명시되지 않는 한 모든 재무 데이터는 연간 기간을 기준으로 하지만 분기별로 업데이트됩니다. 이를 TTM(최근 12개월) 또는 LTM(지난 12개월) 데이터라고 합니다. 자세히 알아보기.분석 모델 및 스노우플레이크이 보고서를 생성하는 데 사용된 분석 모델에 대한 자세한 내용은 당사의 Github 페이지에서 확인하실 수 있습니다. 또한 보고서 활용 방법에 대한 가이드와 YouTube 튜토리얼도 제공합니다.Simply Wall St 분석 모델을 설계하고 구축한 세계적 수준의 팀에 대해 알아보세요.산업 및 섹터 지표산업 및 섹터 지표는 Simply Wall St가 6시간마다 계산하며, 프로세스에 대한 자세한 내용은 Github에서 확인할 수 있습니다.분석가 소스Cue Biopharma, Inc.는 8명의 분석가가 다루고 있습니다. 이 중 1명의 분석가가 우리 보고서에 입력 데이터로 사용되는 매출 또는 수익 추정치를 제출했습니다. 분석가의 제출 자료는 하루 종일 업데이트됩니다.분석가기관Brian SkorneyBairdMadhu KumarBairdZhiqiang ShuBerenberg5명의 분석가 더 보기
Reported Earnings • May 17First 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.
Reported Earnings • Nov 14Third quarter 2025 earnings: EPS exceeds analyst expectations while revenues lag behindThird 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.
Reported Earnings • Aug 13Second quarter 2025 earnings: EPS and revenues exceed analyst expectationsSecond 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.
Reported Earnings • May 14First quarter 2025 earnings: EPS and revenues miss analyst expectationsFirst 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.
Reported Earnings • Apr 01Full year 2024 earnings: EPS exceeds analyst expectations while revenues lag behindFull 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.
Reported Earnings • Nov 17Third quarter 2024 earnings: EPS and revenues exceed analyst expectationsThird 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.
Reported Earnings • May 17First 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.
공시 • May 15Cue Biopharma, Inc. announced that it has received $29.999992 million in fundingOn May 14, 2026, Cue Biopharma, Inc. closed the transaction. The net proceeds after deducting placement agent fees and offering expenses is $28,000,000.
공시 • May 02Cue Biopharma, Inc. announced that it expects to receive $29.999992 million in fundingCue 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 30High number of new and inexperienced directorsThere 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.
공시 • Mar 28+ 1 more updateCue Biopharma, Inc. Announces Chief Executive Officer ChangesOn March 26, 2026, the Board of Directors of Cue Biopharma, Inc. appointed Lucinda Warren, the Chief Financial and Business Officer of the Company, as Interim Chief Executive Officer, effective as of March 27, 2026. Ms. Warren will also continue to serve as the Chief Financial and Business Officer. Ms. Warren will succeed Usman Azam whose resignation as Chief Executive Officer effective as of March 26, 2026. Ms. Warren, age 57, has served as the Company's Chief Financial and Business Officer since February 2026 and previously served as the Company's Chief Business Officer from September 2024 until February 2026. She has over 30 years of global experience in the pharmaceutical and biotechnology sectors. Prior to joining the Company, Ms. Warren was at Johnson & Johnson, a healthcare products company, from 1999 to 2024, where she held roles of increasing responsibility in end-to-end business development, including licensing, mergers and acquisitions, and alliance management, most recently as vice president of business development for Neuroscience and Japan Regionally. Ms. Warren previously held significant roles at Janssen Cilag Australia and Janssen Biologics, where she led business units and managed global transitions. She currently serves as chairman of the board of International School Services. Ms. Warren holds a B.S. in biological sciences with a minor in neurology from the University of Alberta.
Breakeven Date Change • Mar 18No longer forecast to breakevenThe 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.
공시 • Mar 10Cue Biopharma Inc Presents New in Vitro Data for Cue-401 At World Immune Regulation MeetingCue 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.
공시 • Feb 19Cue Biopharma, Inc., Annual General Meeting, Apr 13, 2026Cue Biopharma, Inc., Annual General Meeting, Apr 13, 2026.
공시 • Feb 18Cue Biopharma Inc Announces Preclinical Safety and Tolerability Data for CUE-401 for the Treatment of Autoimmune and Inflammatory DiseasesCue 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.
공시 • Feb 12+ 1 more updateCue Biopharma, Inc. Appoints Lucinda Warren as Chief Business Officer, Effective September 2024Cue Biopharma, Inc. appointed Lucinda Warren as Chief Business Officer of the Company in September 2024. Ms. Warren, age 57, has over 30 years of global experience in the pharmaceutical and biotechnology sectors. Prior to joining the Company, she served as vice president of business development for Neuroscience and Japan regionally at Johnson & Johnson, a healthcare products company, from 2014 to 2024, where she was responsible for end-to-end business development, including licensing, mergers and acquisitions, and alliance management. Ms. Warren previously held significant roles at Janssen Cilag Australia and Janssen Biologics, where she led business units and managed global transitions. She currently serves as chairman of the board of International School Services. Ms. Warren holds a B.S. in biological sciences with a minor in neurology from the University of Alberta.
New Risk • Feb 09New major risk - Revenue and earnings growthEarnings 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 04Independent Chairman of the Board recently bought US$100k worth of stockOn 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 02New major risk - Shareholder dilutionThe 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).
공시 • Dec 19+ 1 more updateCue Biopharma, Inc. has completed a Follow-on Equity Offering in the amount of $14.982143 million.Cue Biopharma, Inc. has completed a Follow-on Equity Offering in the amount of $14.982143 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 35,714,286 Price\Range: $0.28 Discount Per Security: $0.0168 Security Name: Pre-Funded Warrants Security Type: Equity Warrant Securities Offered: 17,857,143 Price\Range: $0.279 Discount Per Security: $0.0168
New Risk • Dec 18New minor risk - Share price stabilityThe 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 29Price target increased by 19% to US$5.00Up 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 19Consensus 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 17New major risk - Revenue and earnings growthEarnings 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 14Third quarter 2025 earnings: EPS exceeds analyst expectations while revenues lag behindThird 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.
분석 기사 • Oct 09Is Cue Biopharma (NASDAQ:CUE) Using Debt In A Risky Way?Warren Buffett famously said, 'Volatility is far from synonymous with risk.' It's only natural to consider a company's...
공시 • Sep 29+ 1 more updateCue Biopharma, Inc. Announces Chief Executive Officer Changes, Effective September 29, 2025Cue Biopharma, Inc. announced that Usman “Oz” Azam, M.D., has been appointed Chief Executive Officer (CEO) of Cue Biopharma, effective September 29, 2025. Daniel Passeri will transition from his current role as CEO to one of Strategic Advisor, effective as of the same date. Dr. Azam brings over 25 years of drug discovery and development leadership as well as operating expertise to Cue Biopharma. Most recently, Dr. Azam served as CEO of Inspirna, Inc., a privately held clinical stage biopharmaceutical company focused on the discovery and development of novel cancer drugs. Prior to Inspirna, Dr. Azam served as CEO of Empyrean Neuroscience, a genetic engineering company, advancing a pipeline of neuroactive compounds targeting disorders of the central nervous system. As President and CEO of Tmunity Therapeutics, he was involved in developing genetically engineered CAR-T cell therapies for solid tumor applications in cancer. He served as Global Head of the Cell and Gene Therapies unit at Novartis where he helped deliver and launch the first-ever FDA approval for a CAR-T cell therapy in hematologic cancers. Dr. Azam is well-respected in the industry for his extensive experience in leadership roles across both innovative biotechnology and large pharmaceutical companies, namely Pfizer Pharmaceuticals, Aspreva Pharmaceuticals, Johnson & Johnson, and GlaxoSmithKline (GSK). The learnings across these roles and his in-depth experience with T cell therapeutics make him well-suited to foster the Company’s next stage of growth.
Major Estimate Revision • Aug 26Consensus revenue estimates decrease by 12%, EPS upgradedThe 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.
공시 • Aug 16Cue Biopharma Announces Initiation of Investigator Sponsored Trial of Cue-102 in Recurrent Glioblastoma MultiformeCue 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 13Second quarter 2025 earnings: EPS and revenues exceed analyst expectationsSecond 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.
공시 • Jul 17Cue 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 CancerCue 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 15High number of new and inexperienced directorsThere 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.
공시 • Jul 02Cue Biopharma, Inc. Provides Update on Most Advanced Clinical Stage Asset, CUE-101 at the DAVA 4th Hawaii Global Summit on Thoracic MalignanciesCue 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.
공시 • Jun 25Cue 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 DiseaseCue 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 18New minor risk - Share price stabilityThe 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).
공시 • Jun 11+ 1 more updateCue Biopharma, Inc. Announces Management ChangesCue Biopharma, Inc. announced that On June 4, 2025, Jill Broadfoot was appointed to the board of directors of the company, the Audit Committee of the Board, and the Corporate Governance and Nominating Committee of the Board, following the recommendation of the Corporate Governance and Nominating Committee of the Board. Ms. Broadfoot will serve as the Chair of the Audit Committee of the Board. The company also announced that Effective June 13, 2025, Daniel R. Passeri, the Company’s Chief Executive Officer, will serve as the Company’s principal financial and accounting officer on an interim basis until a new principal financial and accounting officer is designated due to resignation of Kerri-Ann Millar as Chief Financial Officer, effective June 13, 2025.
Major Estimate Revision • May 20Consensus revenue estimates decrease by 19%, EPS upgradedThe 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 14First quarter 2025 earnings: EPS and revenues miss analyst expectationsFirst 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 23New major risk - Shareholder dilutionThe 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 16Consensus 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.
공시 • Apr 16Cue 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
공시 • Apr 15+ 1 more updateCue Biopharma, Inc., Annual General Meeting, Jun 04, 2025Cue Biopharma, Inc., Annual General Meeting, Jun 04, 2025.
Major Estimate Revision • Apr 07Consensus revenue estimates decrease by 37%, EPS upgradedThe 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 01Full year 2024 earnings: EPS exceeds analyst expectations while revenues lag behindFull 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.
공시 • Mar 13Cue Biopharma, Inc. Appoints Pasha Sarraf as Board of DirectorsCue 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 16New major risk - Shareholder dilutionThe 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 17Third quarter 2024 earnings: EPS and revenues exceed analyst expectationsThird 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.
공시 • Nov 15Cue Biopharma Announces Strategic Organizational TransitionCue 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.
공시 • Nov 09Cue 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 MeetingCue 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.
공시 • Sep 28Cue 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 28New major risk - Share price stabilityThe 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).
공시 • Sep 27Cue 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
공시 • Sep 11Cue Biopharma, Inc. Appoints Lucinda Warren as Chief Business OfficerCue 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 21Consensus 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.
공시 • Aug 18Cue Biopharma Receives Non-Compliance Letter from Nasdaq Regarding Minimum Bid Price RequirementOn 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 16Second quarter 2024 earnings: EPS and revenues exceed analyst expectationsSecond 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 27Price target decreased by 15% to US$8.00Down 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.
공시 • Jul 03+ 2 more updatesCue Biopharma, Inc.(NasdaqCM:CUE) dropped from Russell Small Cap Completeness IndexCue Biopharma, Inc.(NasdaqCM:CUE) dropped from Russell Small Cap Completeness Index
공시 • Jun 10Cue Biopharma, Inc. Appoints Michael J. Fox to the Board of Directors and the Compensation CommitteeOn 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 17Consensus 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 10First quarter 2024 earnings: EPS and revenues exceed analyst expectationsFirst 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.
공시 • Apr 28Cue Biopharma, Inc., Annual General Meeting, Jun 05, 2024Cue 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.
분석 기사 • Apr 16Here's Why Cue Biopharma (NASDAQ:CUE) Can Manage Its Debt Despite Losing MoneyDavid Iben put it well when he said, 'Volatility is not a risk we care about. What we care about is avoiding the...
New Risk • Apr 10New major risk - Revenue and earnings growthEarnings 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 04Consensus 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 01Full year 2023 earnings: EPS and revenues exceed analyst expectationsFull 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 13New major risk - Revenue and earnings growthEarnings 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 18New minor risk - Market cap sizeThe 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).
분석 기사 • Dec 30Does Cue Biopharma (NASDAQ:CUE) Have A Healthy Balance Sheet?Warren Buffett famously said, 'Volatility is far from synonymous with risk.' So it seems the smart money knows that...
Major Estimate Revision • Nov 10Consensus 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 05Third quarter 2023 earnings: EPS and revenues exceed analyst expectationsThird 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.
공시 • Nov 04Cue 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 2023Cue 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 03New minor risk - Share price stabilityThe 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).
공시 • Sep 27Cue 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.
공시 • Sep 15Cue Biopharma, Inc. Announces Resignation of Aaron Fletcher as Member of the Board of Directors, Effective October 9, 2023On 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.
분석 기사 • Aug 11Is Cue Biopharma (NASDAQ:CUE) Using Too Much Debt?David Iben put it well when he said, 'Volatility is not a risk we care about. What we care about is avoiding the...
Reported Earnings • Aug 09Second quarter 2023 earnings: EPS and revenues exceed analyst expectationsSecond 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.
공시 • May 26Cue 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 MeetingCue 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 17Consensus revenue estimates decrease by 91%, EPS upgradedThe 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.
공시 • May 11Cue 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 11First quarter 2023 earnings: EPS in line with expectations, revenues disappointFirst 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 28Consensus 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 23Full year 2022 earnings: Revenues exceed analysts expectations while EPS lags behindFull 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.
공시 • Feb 17Cue Biopharma, Inc. Announces the Appointment of Rafi Ahmed to its Scientific Advisory BoardCue 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.
공시 • Jan 24Cue Biopharma, Inc. Announces Executive ChangesCue 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 21Consensus forecasts updatedThe 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 16Third quarter 2022 earnings: EPS exceeds analyst expectations while revenues lag behindThird 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.
Seeking Alpha • Oct 04Cue Biopharma shares rise ~10% on FDA fast track nod for head and neck cancer drugCue Biopharma (NASDAQ:CUE) on Tuesday said it had got a fast track designation from the U.S. FDA for its drug candidate CUE-101 for the treatment of head and neck cancer associated with human papilloma virus. CUE stock jumped 9.6% to $2.62 in early trading. The designation was for CUE-101 as a monotherapy and in combination with Merck's (MRK) Keytruda for the treatment of human papilloma virus recurrent/metastatic head and neck squamous cell carcinoma. The FDA's Fast Track approval is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. "To date in its Phase 1b clinical trials, CUE-101 has demonstrated a favorable tolerability profile and single-agent anti-tumor activity in monotherapy as well as encouraging anti-tumor clinical activity in combination with (Keytruda)," CUE senior vice president of clinical development Matteo Levisetti said in a statement.
분석 기사 • Sep 23Despite Lacking Profits Cue Biopharma (NASDAQ:CUE) Seems To Be On Top Of Its DebtLegendary fund manager Li Lu (who Charlie Munger backed) once said, 'The biggest investment risk is not the volatility...
분석 기사 • Aug 26News Flash: 4 Analysts Think Cue Biopharma, Inc. (NASDAQ:CUE) Earnings Are Under ThreatThe analysts covering Cue Biopharma, Inc. ( NASDAQ:CUE ) delivered a dose of negativity to shareholders today, by...
Major Estimate Revision • Aug 25Consensus 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.