Agenus Reports Fourth Quarter and Full Year 2023 Results FDA Grants Fast Track designation for BOT/BAL in metastatic, refractory colorectal cancer (CRC) patients who have failed 1st and 2nd line standard of care treatments Data from Phase 1 of BOT/BAL in refractory CRC showed durable ORR of 24% in patients with non-active liver metastases (NLM); Completed enrollment of randomized Phase 2 trial (n=230) Clinical data sets path for expansion opportunities in pancreas, lung, neoadjuvant CRC, and melanoma LEXING ...

LEXINGTON, Mass.--(BUSINESS WIRE)--Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, today announced that the first preclinical data from BMS-986442 (AGEN1777) will be presented in an oral presentation at the upcoming AACR Meeting, to be held April 5 – 10, 2024 in San Diego, CA. In non-clinical assays, BMS-986442 demonstrated superior immune activation both as monotherapy and in combination with PD-(L)1 blockade compared to ...

LEXINGTON, Mass.--(BUSINESS WIRE)--Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, today announced that the Compensation Committee of Agenus’ Board of Directors granted inducement awards to Nils Eckardt, Kent Barnes, and Brian Greenblatt, in connection with their appointments as Chief Medical Affairs Officer, Head of Marketing and Sales, and Vice President Commercial Operations and Business Analytics, respectively. The Compen ...

LEXINGTON, Mass.--(BUSINESS WIRE)--Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in discovering and developing novel immunological agents to treat various cancers, today announced that the Company will release its fourth quarter and year end 2023 financial results before the market opens on Thursday, March 14, 2024. Agenus executives will host a conference call and webcast at 8:30 a.m. ET that morning to discuss the results and provide a corporate update. Conference Call: To access dial-in numbers, plea ...

Three otherwise innocuous words -- reverse stock split -- can cause much disappointment and even sow panic in an investor community. Shareholders of clinical-stage biotech Agenus (AGEN -29.54%) experienced this vividly on Thursday when their company announced its intention to start going down that road. The stock's price fell sharply, by almost 30%, contrasting with the 0.6% gain of the benchmark S&P 500 index.Twenty shares will become oneIn a regulatory filing and a letter to its shareholders, both publish ...

Group 1: Analyst-Backed Stocks Overview - The article discusses stocks that analysts believe have the potential for significant returns, specifically those with a 10-bagger potential [2][10] - It highlights the skepticism retail investors often have towards Wall Street analysts, despite the potential for high returns [1][2] Group 2: Company Summaries - **AST SpaceMobile (ASTS)**: A satellite designer aiming to create a cellular broadband network that connects smartphones to satellites, rated a "buy" with a price target of $23 by Deutsche Bank [3][4] - **Microvast (MVST)**: A battery technology company focused on electric commercial vehicles, facing challenges in the market but rated a strong buy with an $8 price target [5][6] - **Pixelworks (PXLW)**: Provides video processing semiconductors, currently facing bearish sentiment but analysts have a price target of $14 [7][8] - **Quantum Computing (QUBT)**: Specializes in quantum computing technology, with a price target of $8.75, representing a compelling investment opportunity [9][10] - **Agenus (AGEN)**: A biotech firm focused on immunotherapy, with a large addressable market projected to grow to $200.55 billion by 2030, rated a strong buy with a $6.67 price target [11][12] - **Passage Bio (PASG)**: Focuses on genetic medicines for neurodegenerative diseases, with a market projected to reach $77.82 billion by 2029, rated a strong buy with a $10.50 price target [13][14] - **Palatin Technologies (PTN)**: Develops treatments for inflammatory and autoimmune conditions, with a market projected to grow to $141.58 billion by 2030, rated a moderate buy with a $60 target [15][16]

Industry Overview - The biotech sector has experienced a significant rally, with the SPDR S&P Biotech ETF (XBI) increasing by 31% in the last three months after being mostly down for the past three years [1] - Despite the rally, the monetary and regulatory environment remains challenging for biotech stocks [1] - Long-term investment is essential in biotech, as it can take years for drug candidates to receive FDA approval after entering clinical trials [1] Company Highlights Eli Lilly and Company (LLY) - Eli Lilly was one of the top-performing biotech stocks in 2023, with a rise of over 70% [3] - The anticipated approval of the obesity drug Zepbound in November 2023 is a key catalyst for the company's performance [3] - The company is also focused on donanemab, a clinical-stage drug for Alzheimer's disease, with an FDA decision expected in early 2024 [3][4] - LLY has a forward price-to-earnings (P/E) ratio of approximately 97x, indicating it is expensive relative to historical values, but is projected to have earnings growth of 91% in the next 12 months [4] Amylyx (AMLX) - Amylyx transitioned from a clinical-stage to a commercial-stage company after receiving FDA approval for Relyvrio, its treatment for ALS [6] - The company has reported three profitable quarters and anticipates a 79% increase in earnings over the next year [6] - Despite this, AMLX stock has decreased by 64% in the past year, potentially due to heavy short interest and concerns over slowing revenue growth [6] - Upcoming Phase 3 trial results from the PHOENIX clinical trial may provide additional data to support approval by the European Medicines Agency (EMA) [6] Agenus (AGEN) - Agenus is a clinical-stage company focused on developing cancer immunotherapies [7] - The company is working on a Biologics License Application (BLA) for accelerated approval of its lead candidate, botensilimab, targeting HER-positive metastatic colorectal cancer [7] - Although Agenus is a penny stock and not widely covered by analysts, four out of five analysts have rated it as a Strong Buy [8]

Core Insights - Agenus Inc. has reported promising results from the NEST-1 study, showcasing the potential of the BOT/BAL combination in treating colorectal cancer (CRC) [1][4] - The company is positioned for significant growth in the neoadjuvant setting, particularly for metastatic microsatellite stable (MSS) CRC patients, which represent a large portion of CRC cases [5][9] - Despite current trading pressures, Agenus is viewed as a speculative investment opportunity due to its innovative pipeline and potential market impact [1][20] Company Background - Agenus is focused on immunological cancer treatments, with a diverse pipeline that includes 9 clinical assets and over 20 ongoing studies [1] - The company's platform technology centers around the botensilimab (BOT) antibody, which enhances anti-tumor immune responses [2] - Agenus has established strategic partnerships that could yield up to $2.5 billion in milestone payments and significant royalties [3] NEST-1 Study Results - The NEST-1 study demonstrated that 67.5% of MSS CRC patients experienced at least 50% tumor shrinkage, a notable achievement given the typical resistance of these patients to immune-oncology therapies [4] - The study also reported a 100% elimination rate of circulating tumor DNA (ctDNA) in tested patients, indicating a strong potential for long-term disease-free survival [4] Market Opportunity - MSS CRC accounts for 85% of all CRC cases, suggesting a substantial market for the BOT/BAL neoadjuvant therapy [5] - The planned Biologics License Application (BLA) filing in mid-2024 is a critical step for Agenus, potentially marking its transition into a commercial entity [5][9] Future Developments - Agenus aims to expand its applications beyond CRC, with plans for supplemental BLA filings in pancreatic cancer, melanoma, and non-small cell lung cancer (NSCLC) [6] - The company is also exploring the BOT+BAL combination in various cancer types, showing promising results in ovarian cancer and sarcomas [6][7] Financial Outlook - Agenus is projected to experience strong double-digit growth, with expectations to approach $1 billion in annual revenue by 2030 [11] - The company is currently trading at a discount relative to its potential revenue, with a forward price-to-sales ratio significantly below industry averages [15] Upcoming Catalysts - Key upcoming milestones include Phase 2 data updates and the anticipated BLA filing, which could significantly impact the company's growth trajectory [10][11]

Core Insights - Agenus Inc. announced results from the NEST-1 study, evaluating the combination of botensilimab and balstilimab for colorectal cancer treatment, presented by Dr. Pashtoon Kasi at the ASCO-GI conference [1][2] Study Highlights - Treatment involved a single dose of botensilimab (BOT) and two doses of balstilimab (BAL) administered between diagnosis and surgery, approximately over four weeks [3] - In the Microsatellite Stable (MSS) CRC cohort, 67.5% of patients experienced tumor shrinkage of ≥50%, while 100% of patients in the Microsatellite Instability-High (MSI-H) CRC cohort showed similar results [3] - The treatment did not delay surgical procedures, with only two instances of Grade 3 Treatment-Related Adverse Events (TRAEs) reported [3] - The study demonstrated that BOT/BAL eliminated circulating tumor DNA (ctDNA) in 100% of tested patients, which is associated with long-term Disease-Free Survival (DFS) [3] - An independent observational study indicated that patients who remained ctDNA negative post-treatment had better 2-year DFS rates compared to ctDNA-positive patients [3] Expert Commentary - Dr. Steven O'Day, Chief Medical Officer of Agenus, highlighted the remarkable results of the NEST-1 trial, noting significant tumor regression and immune cell infiltration in a short time frame, particularly in the MSS CRC cohort, which constitutes 90% of all CRC cases [4] About Botensilimab - Botensilimab is an investigational multifunctional anti-CTLA-4 immune activator designed to enhance both innate and adaptive anti-tumor immune responses, particularly in "cold" tumors that typically respond poorly to standard therapies [5] Clinical Development - Approximately 750 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials, showing clinical responses across nine metastatic, late-line cancers [6] Company Overview - Agenus is a leading immuno-oncology company focused on cancer and infectious diseases, with a comprehensive pipeline of immunological agents aimed at expanding patient populations benefiting from cancer immunotherapy [7]

nopparit/iStock via Getty Images iTeos Therapeutics (NASDAQ:ITOS) is gearing up to report results from several of its programs in 2024. I believe that investors can benefit here, because there is potential with multiple shots on goal. Especially, with respect to the fact that there are two protein targets which have been validated to do well in targeting patients with cancers. Having said that, this company's pipeline is not solely only built around the targeting of TIGIT protein with Belrestotug [EOS-448] ...