Core Viewpoint - Agenus Inc. is set to release its fourth quarter and year-end 2023 financial results on March 14, 2024, before market opening, followed by a conference call for discussion [1]. Group 1: Financial Results Announcement - The financial results will be released before the market opens on March 14, 2024 [1]. - A conference call and webcast will take place at 8:30 a.m. ET on the same day to discuss the results and provide a corporate update [1]. Group 2: Company Overview - Agenus is a leader in immuno-oncology, focusing on cancer and infectious diseases with a diverse pipeline of immunological agents [3]. - The company's mission is to enhance patient access to cancer immunotherapy through combination therapies, utilizing a wide range of antibody therapeutics, adoptive cell therapies, and adjuvants [3]. - Agenus is headquartered in Lexington, MA, and provides regular updates on its website and social media channels [3].

Core Viewpoint - Agenus announced a reverse stock split, causing a significant drop in its stock price by nearly 30%, contrasting with the S&P 500's slight gain [1]. Group 1: Reverse Stock Split Details - Agenus plans a reverse stock split at a ratio of 1 for every 20 shares currently held, pending an investor vote on April 3 [2]. - The primary motivation for this move is to raise the company's stock price above the $1 minimum required by Nasdaq, as the current price is approximately $0.65 [2]. Group 2: Investor Sentiment and Company Goals - Investors reacted negatively to the announcement, viewing the reverse stock split as a sign of desperation for a struggling business [3]. - The company aims to use this time to achieve key milestones, including submitting a Biologics License Application for metastatic colorectal cancer and prioritizing other clinical programs [3].

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]

Core Insights - iTeos Therapeutics is preparing to report results from multiple clinical programs in 2024, focusing on two validated protein targets for cancer treatment, namely TIGIT and the adenosine pathway [2][9] - The company is advancing belrestotug (EOS-448) targeting the TIGIT protein and inupadenant (EOS-850) targeting the adenosine pathway, with the aim of enhancing drug potency against advanced solid tumors [2][9] Pipeline Developments - Two key phase 2 studies involving belrestotug in combination with dostarlimab are set to report in 2024, targeting non-small cell lung cancer (NSCLC) and head and neck squamous cell carcinoma (HNSCC) [3][9] - The GALAXIES Lung-201 study will focus on 1st-line advanced/metastatic NSCLC patients, while the TIG-006 study will assess the combination in 1st-line PD-L1 positive advanced or metastatic HNSCC patients [3][5] Market Potential - The global NSCLC market is projected to reach $36.9 billion by 2031, while the head and neck cancer drugs market is expected to surpass $3.9 billion by 2030 [3][5] - The studies will target specific patient populations, including those with high PD-L1 expression, which could enhance market opportunities despite competition [3][5] Competitive Landscape - iTeos faces competition from several companies developing anti-TIGIT therapies, including Beigene, Novartis, and Merck, among others [5] - The differentiation of belrestotug lies in its unique design and binding properties, which may provide a competitive edge over existing therapies [5][9] Financial Position - As of September 30, 2023, iTeos Therapeutics reported cash and cash equivalents of $644.9 million, sufficient to fund operations through 2026 and support multiple phase 3 studies [6] - The company has a Sales Agreement with Cowen for an aggregate offering price of $125 million, providing a financial cushion if additional funds are needed [6]

Core Insights - Agenus Inc. is participating in the B. Riley Virtual Healthcare Conference on January 18th, where Dr. Garo Armen will engage in a fireside chat and investor one-on-ones [1] - The fireside chat is scheduled for 3:00 p.m. ET on January 18th, and a replay will be available on the company's website afterward [1] Company Overview - Agenus is a leading immuno-oncology company focused on treating cancer and infectious diseases with a diverse pipeline of immunological agents [2] - The company's mission is to broaden the patient population benefiting from cancer immunotherapy through combination approaches, utilizing a wide range of antibody therapeutics, adoptive cell therapies, and adjuvants [2] - Agenus is headquartered in Lexington, MA, and provides regular updates that may be important to investors via its website and social media channels [2]

Financial Performance - Research and development revenue for Q3 2023 was approximately $3.4 million, down from $4.6 million in Q3 2022, primarily due to deferred revenue recognition under Gilead Collaboration Agreements[98] - Non-cash royalty revenue from GSK increased by $11.1 million to approximately $20.4 million for Q3 2023, compared to $9.2 million in Q3 2022, driven by higher vaccine sales and milestone achievements[100] - Research and development expenses rose 12% to $51.4 million for Q3 2023, up from $46.0 million in Q3 2022, primarily due to increased third-party services and personnel costs[101] - General and administrative expenses increased by 4% to $18.9 million for Q3 2023, compared to $18.1 million in Q3 2022, mainly due to higher personnel costs[102] - Interest expense, net increased to approximately $18.6 million for Q3 2023 from $15.6 million in Q3 2022, attributed to higher non-cash interest and finance lease expenses[103] - Non-cash royalty revenue for the nine months ended September 30, 2023, increased by $34.5 million to approximately $61.5 million, compared to $27.0 million for the same period in 2022[105] - Research and development expenses for the nine months ended September 30, 2023, increased by 26% to $167.8 million from $133.4 million in the same period of 2022[106] - General and administrative expenses for the nine months ended September 30, 2023, rose by 3% to $57.6 million, compared to $56.0 million in the same period of 2022[108] - Interest expense, net for the nine months ended September 30, 2023, increased to approximately $53.7 million from $44.5 million in the same period of 2022[110] - Net cash used in operating activities for the nine months ended September 30, 2023, was $183.8 million, compared to $128.0 million for the same period in 2022[125] Assets and Funding - As of September 30, 2023, the company had an accumulated deficit of $1.9 billion and cash, cash equivalents, and short-term investments of $106.3 million[113][118] - The company anticipates additional funding from a milestone payment expected by the end of 2023 and is in discussions to sell non-strategic assets valued at approximately $65.0 million[120] - Cash, cash equivalents, and short-term investments at September 30, 2023, totaled $106.3 million, which are subject to interest rate fluctuations[127] Research and Development - The lead asset, botensilimab, showed a 12-month overall survival rate of 74% in a Phase 1 study of 70 patients with refractory microsatellite stable metastatic colorectal cancer, compared to a median overall survival of 12.9 months for standard care[82] - The botensilimab/balstilimab combination received Fast Track designation from the FDA for treating non-MSI-H/dMMR metastatic colorectal cancer patients without active liver involvement[83] - The company aims to file its first biologics license application for the botensilimab/balstilimab combination in colorectal cancer by mid-2024[83] - MiNK Therapeutics, a subsidiary, is developing unmodified and engineered iNKT cell therapies, with a Phase 1 trial showing a 42% tumor reduction in a patient with metastatic gastric cancer[97] - The company has a pipeline of novel allogeneic iNKT therapies for treating cancer and other immune-mediated diseases[83] - The company has established collaborations with several firms, resulting in over a dozen antibody programs currently in pre-clinical or clinical development[84] Collaborations and Milestones - The company is eligible to receive up to $315 million in potential milestone payments from Incyte, along with royalties on future sales, following the termination of certain programs[85] - Under the collaboration with Merck, the company is eligible for up to $85 million in potential milestone payments and royalties on future sales for a monospecific antibody targeting ILT4[86] Investment and Risk Management - The investment policy prohibits investing in structured investment vehicles and asset-backed commercial paper, focusing on preserving principal and maintaining liquidity[129] - The investment policy specifies credit quality standards and limits credit exposure from any single issue or issuer[129] - The company does not invest in derivative financial instruments, indicating no material market risk exposure related to derivatives[129] - The company does not currently employ specific strategies to manage foreign currency exchange rate risks, which are primarily concentrated in the British Pound, Euro, and Swiss Franc[126] - There has been no material change to the company's interest rate exposure since the last annual report[128] - The company’s interest income fluctuates with changes in interest rates due to the nature of its investments[127] - Approximately 0.9% of cash used in operations for the nine months ended September 30, 2023, was from foreign subsidiaries, down from 1.7% for the year ended December 31, 2022[126] Future Outlook - Future cash generation will depend on achieving regulatory approval and market acceptance of product candidates[125]

Financial Data and Key Metrics Changes - The company ended Q3 2023 with a cash balance of $100.63 million, down from $193.4 million at the end of the previous year [23] - For Q3 2023, the company recognized revenue of $24.3 million, resulting in a net loss of $64.5 million, while the net loss for the nine months of 2023 totaled $208.9 million [23] Business Line Data and Key Metrics Changes - The company is focusing on three key priorities: submitting a biologics license application for colorectal cancer, prioritizing clinical programs for rapid approval, and reallocating resources to achieve these goals [6][9] - The Phase II clinical trial in MSS-CRC has shown a 24% overall response rate, with a median overall survival rate exceeding 21 months, significantly better than the standard of care [11][19] Market Data and Key Metrics Changes - The company is addressing an urgent unmet need in the colorectal cancer market, particularly for patients with advanced disease, by initiating a compassionate use program [7][8] - The company is also expanding its clinical trials to include earlier lines of therapy, potentially changing treatment paradigms for colorectal cancer [12] Company Strategy and Development Direction - The company aims to submit its first biologics license application in mid-2024, focusing on late-stage colorectal cancer [6][10] - The strategic focus includes advancing clinical programs in refractory pancreatic cancer and new adjuvant settings in colorectal cancer [8][9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of Botensilimab to provide significant benefits over existing therapies, particularly in challenging cancer types [17][19] - The company is optimistic about securing additional cash through milestone payments and asset sales, which are expected to total approximately $200 million [9][10] Other Important Information - The company is in advanced discussions for potential structured financing and corporate collaborations with larger pharmaceutical or biotech companies [10][48] - Management emphasized the importance of rapid development and the need for substantial financial commitments from potential partners [48] Q&A Session Summary Question: When can we expect initial Phase II data for the MSS CRC study? - Management indicated that data from the first 70 patients has been disclosed, with further data needing cleanup before publication, ideally around the time of the BLA submission [27] Question: What is the regulatory bar for the randomized CRC study? - The company needs to demonstrate a meaningful improvement over standard care, with current response rates showing a significant advantage [32] Question: What is the updated cash guidance? - The company expects a cash burn of approximately $40 million for Q4 and anticipates bringing in around $200 million through non-stock issuance transactions by mid-next year [38] Question: What is the plan for CRC patients in the Phase III confirmatory study? - The company is exploring options for both second and first-line studies, with ongoing discussions with the FDA to determine the best path forward [40][51]