Company Overview - Agenus Inc. (AGEN) shares fell 58.8% on July 18 following the FDA's discouragement of the accelerated approval pathway for its immunotherapy combination botensilimab (BOT) and balstilimab (BAL) in treating relapsed/refractory microsatellite stable colorectal cancer (r/r MSS CRC) [1] - The FDA indicated that the objective response rate (ORR) from the phase II study may not translate into a survival benefit [1] Clinical Study Results - Interim data from a phase II study showed that the BOT/BAL combination at a dose of 75 mg BOT and 240 mg BAL achieved an ORR of 19.4%, with 90% of patients alive at this dosage [1] - The FDA has agreed on the dosing regimen for a phase III study, which includes BOT (75 mg) every six weeks for up to four doses and BAL (240 mg) every two weeks for up to two years [2] Future Developments - The FDA has proposed including a BOT monotherapy arm in the phase III study, and Agenus is seeking a partner in the U.S. for this study [2] - Apart from colorectal cancer, the BOT/BAL combination has shown clinical activity in other cancer types, including lung cancer, melanoma, and pancreatic cancers [3] Market Performance - Year-to-date, Agenus shares have declined 55.9%, contrasting with a 1.4% decline in the industry [2]

Core Viewpoint - Agenus Inc. is under investigation for potential securities fraud and unlawful business practices following a significant stock price drop after an unfavorable FDA meeting regarding its immunotherapy combination [1][2]. Group 1: Company Developments - On July 18, 2024, Agenus announced the results of its end-of-Phase 2 meeting with the FDA concerning its immunotherapy combination, botensilimab (BOT) and balstilimab (BAL), for treating adult patients with relapsed/refractory microsatellite stable colorectal cancer [2]. - The FDA advised against the submission of results for Accelerated Approval, indicating that the objective response rates may not translate to a survival benefit [2]. Group 2: Market Reaction - Following the FDA's announcement, Agenus's stock price fell by $10.43 per share, representing a decline of 58.83%, closing at $7.30 per share on July 18, 2024 [2]. Group 3: Legal Context - Pomerantz LLP is investigating claims on behalf of investors of Agenus, focusing on potential securities fraud or other unlawful business practices by the company and its officers or directors [1].

Core Insights - Agenus (NASDAQ:AGEN) stock is experiencing a significant decline following the results from a Phase 2 clinical trial for its colorectal cancer treatment, botensilimab and balstilimab [1] - The FDA advised against seeking Accelerated Approval for the treatment due to the lack of evidence that the objective response rates translate to survival benefits, which delays the development process [1] - The company remains committed to exploring all possible pathways to make the treatment available, including potential partnerships for a successful Phase 3 trial [2] Stock Movement - AGEN stock is down 54.5% as of Thursday morning, with heavy trading volume of approximately 5.2 million shares, significantly above the daily average of about 763,000 shares [3]

Human life expectancy has doubled since the 1900s, mostly attributed to advancements in lifestyle, living standards and medicine. Thanks to biotech companies that produce transformative drugs and treatments, we now have the collective ability to combat diseases that used to bring entire nations down. And it’s getting better all the time. So, it’s no surprise that investors are looking at biotech stocks to buy. A lot of money is to be made, especially if their prices skyrocket. However, investing in biotech ...

Core Viewpoint - Small-cap stocks are expected to benefit from anticipated rate cuts by the central bank in 2025, presenting potential investment opportunities in this sector [1] Group 1: Small-Cap Stocks Overview - Small-cap and mid-cap stocks are sensitive to interest rates due to their reliance on debt instruments for long-term financial obligations [1] - The Federal Reserve is expected to cut rates by 2025, which could serve as a catalyst for smaller companies struggling in a high-rate environment [1] Group 2: Agenus - Agenus is a small-cap immunology company with a market cap of $224 million, focusing on an antibody cocktail for advanced metastatic colorectal cancer [2] - The company aims for an accelerated regulatory filing and plans to expand its total addressable market, potentially transforming its therapy into a multi-billion-dollar revenue source [2] - Recent cash infusion from Ligand Pharmaceuticals provides Agenus with the necessary funds to reach important regulatory milestones and other clinical catalysts in 2025 [3] Group 3: Canopy Growth - Canopy Growth, a Canadian cannabis cultivator, has seen its shares nearly double this year due to the U.S. proposal to reclassify cannabis under the Controlled Substances Act [4] - Despite being based in Canada, Canopy plans to enter the U.S. market once legal conditions allow, indicating a long-term growth strategy [4] - The stock may not appeal to short-term investors, but its long-term strategy positions it as a significant player in the global marijuana market [4] Group 4: Curaleaf Holdings - Curaleaf Holdings is recognized as a leading cannabis company with a market cap of $4.1 billion, holding a strong position in both Europe and the U.S. [5] - The cumulative commercial opportunity in these markets is estimated to be nearly $300 billion, highlighting significant growth potential [5] - Curaleaf's status as a frontrunner in international expansion among U.S. multi-state operators presents generational wealth-building potential for long-term shareholders [5][6]

Agenus Inc. (NASDAQ:AGEN) Q1 2024 Earnings Conference Call May 7, 2024 8:30 AM ET Company Participants Zack Armen - Head of Investor Relations Garo Armen - Chairman & Chief Executive Officer Steven O’Day - Chief Medical Officer Robin Taylor - Chief Commercial Officer Christine Klaskin - Vice President of Finance & Principal Financial and Accounting Officer Conference Call Participants Emily Bodnar - H.C. Wainright Mayank Mamtani - B. Riley Securities Matthew Phipps - William Blair Operator Thank you for sta ...

Agenus (AGEN) came out with a quarterly loss of $3.04 per share versus the Zacks Consensus Estimate of a loss of $3.58. This compares to loss of $4.40 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 15.08%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.40 per share when it actually produced a loss of $2.60, delivering a surprise of -550%.Over the last four quarters, the company has surp ...

[Form 8-K Current Report](index=1&type=section&id=Form%208-K%20Current%20Report) This report details Agenus Inc.'s recent financial announcement and the accompanying exhibit [Results of Operations and Financial Condition](index=3&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) Agenus Inc. announced its first quarter 2024 financial results on May 7, 2024, via a press release furnished as Exhibit 99.1, which is not considered 'filed' under Section 18 of the Securities Exchange Act - Agenus Inc. announced its financial results for the quarter ended March 31, 2024[7](index=7&type=chunk) - The announcement was made on May 7, 2024, through a press release furnished as Exhibit 99.1[7](index=7&type=chunk) - The information is explicitly stated as "furnished" and not "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, which limits its legal liability in certain contexts[7](index=7&type=chunk) [Financial Statements and Exhibits](index=3&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This section lists the sole exhibit furnished with the Form 8-K report, which is the May 7, 2024 press release containing the company's financial results - The report includes one furnished exhibit: 99.1 Press Release dated May 7, 2024[7](index=7&type=chunk)

[PART I - FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section provides the unaudited condensed consolidated financial statements and management's discussion and analysis for the first quarter of 2024 [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents the unaudited condensed consolidated financial statements for Agenus Inc. for the quarter ended March 31, 2024 [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Agenus reported total assets of **$256.6 million**, a decrease from **$313.9 million**, with a widening stockholders' deficit Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2024 | December 31, 2023 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $52,856 | $76,110 | | Total current assets | $60,352 | $112,416 | | Total assets | $256,559 | $313,913 | | **Liabilities & Stockholders' Deficit** | | | | Total current liabilities | $256,002 | $255,897 | | Total liabilities | $446,336 | $462,295 | | Total stockholders' deficit | $(190,323) | $(148,382) | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Total revenues increased to **$28.0 million**, and the net loss narrowed to **$61.9 million** for Q1 2024 Q1 2024 vs. Q1 2023 Statement of Operations (in thousands, except per share data) | Metric | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Total revenues | $28,005 | $22,902 | | Research and development expense | $(43,925) | $(57,118) | | General and administrative expense | $(16,855) | $(18,237) | | Operating loss | $(32,882) | $(54,341) | | Net loss attributable to Agenus Inc. common stockholders | $(61,940) | $(68,307) | | Basic and diluted net loss per share | $(3.04) | $(4.31) | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities improved to **$38.2 million**, with a **$23.3 million** decrease in cash balance Q1 2024 vs. Q1 2023 Cash Flow Summary (in thousands) | Cash Flow Activity | Q1 2024 | Q1 2023 | | :--- | :--- | :--- | | Net cash used in operating activities | $(38,191) | $(58,526) | | Net cash provided by (used in) investing activities | $229 | $(11,489) | | Net cash provided by financing activities | $14,830 | $56,250 | | Net decrease in cash, cash equivalents and restricted cash | $(23,254) | $(13,855) | [Notes to Unaudited Condensed Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Condensed%20Consolidated%20Financial%20Statements) Key notes include going concern disclosure, a **$75 million** subsequent financing, and a **1-for-20 reverse stock split** - The company disclosed **substantial doubt** about its ability to continue as a going concern for one year, despite plans to secure additional funding[23](index=23&type=chunk)[118](index=118&type=chunk) - On May 6, 2024, Agenus entered a Purchase and Sale Agreement with Ligand Pharmaceuticals for **$75.0 million upfront** in exchange for future milestones and royalties, with an option for an additional **$25.0 million** investment[78](index=78&type=chunk)[80](index=80&type=chunk) - A **1-for-20 reverse stock split** became effective on April 12, 2024, with all share and per-share data retroactively adjusted[29](index=29&type=chunk)[76](index=76&type=chunk)[77](index=77&type=chunk) - In Q1 2024, the company received net proceeds of approximately **$17.2 million** from the sale of **1.2 million shares** through its at-the-market (ATM) offering facility[64](index=64&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses Q1 2024 performance, cost controls, and liquidity, highlighting the **$75 million** Ligand financing - The company is pursuing a global regulatory strategy for its lead program, botensilimab in combination with balstilimab, aiming to initiate a Biologics License Application (BLA) submission to the FDA by the end of 2024 for potential accelerated approval[89](index=89&type=chunk) - In August 2023, the company prioritized resources to accelerate its lead asset, postponing other programs and reducing its workforce by approximately **25%** to preserve liquidity[24](index=24&type=chunk)[119](index=119&type=chunk) - Agenus received a **$25.0 million milestone payment** from Bristol-Myers Squibb (BMS) in January 2024 for the dosing of the first patient in a Phase 2 clinical trial for AGEN1777[97](index=97&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) Revenues increased due to non-cash royalties, while R&D and G&A expenses decreased due to cost-control measures - Non-cash royalty revenue from GSK's vaccines increased by **$8.7 million** to **$27.8 million** in Q1 2024 compared to Q1 2023[105](index=105&type=chunk) - R&D expenses decreased by **23%** year-over-year, driven by a **$7.4 million** decrease in third-party services, a **$2.1 million** decrease in personnel costs, and a **$4.4 million** decrease in subsidiary expenses[106](index=106&type=chunk) - G&A expenses decreased by **8%** year-over-year, primarily due to a **$1.5 million** decrease in subsidiary activities[107](index=107&type=chunk) [Liquidity and Capital Resources](index=35&type=section&id=Liquidity%20and%20Capital%20Resources) The company ended Q1 2024 with **$52.9 million** in cash, with management expecting the Ligand financing to extend liquidity into 2025 - The company had **$52.9 million** in cash and cash equivalents as of March 31, 2024, a decrease of **$23.3 million** from December 31, 2023[116](index=116&type=chunk) - Management believes existing cash plus the **$75.0 million** from the Ligand agreement and other potential funding will satisfy liquidity needs into 2025, despite the formal 'going concern' disclosure[117](index=117&type=chunk)[118](index=118&type=chunk) - Net cash used in operating activities for Q1 2024 was **$38.2 million**, compared to **$58.5 million** for Q1 2023, indicating improved operational cash management[122](index=122&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) Primary market risks include foreign currency fluctuations and interest rate changes, with no material changes reported - The company's main market risk is foreign currency exchange rate risk related to transactions denominated in British Pounds and Euros[123](index=123&type=chunk) - The company does not currently use derivative instruments or hedging to manage its currency or interest rate exposures[123](index=123&type=chunk)[126](index=126&type=chunk) [Item 4. Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Disclosure controls and procedures were effective as of March 31, 2024, with no material changes in internal control - Management concluded that disclosure controls and procedures were effective as of the end of the period covered by the report[127](index=127&type=chunk) - No changes in internal control over financial reporting occurred during Q1 2024 that materially affected, or are reasonably likely to materially affect, internal controls[129](index=129&type=chunk) [PART II - OTHER INFORMATION](index=40&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, other information, and exhibits filed with the report [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) Agenus reports no material legal proceedings currently involving the company - The company is not currently involved in any material legal proceedings[132](index=132&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) No material changes to the previously disclosed risk factors have occurred since the 2023 Annual Report - No material changes to the risk factors previously disclosed in the 2023 Form 10-K have occurred[133](index=133&type=chunk) [Item 5. Other Information](index=40&type=section&id=Item%205.%20Other%20Information) No directors or executive officers adopted or terminated Rule 10b5-1 trading plans in Q1 2024 - During the quarter ended March 31, 2024, no directors or executive officers adopted or terminated a Rule 10b5-1 trading arrangement[134](index=134&type=chunk) [Item 6. Exhibits](index=40&type=section&id=Item%206.%20Exhibits) The exhibits include officer certifications and XBRL data files filed with the Form 10-Q - The exhibits filed with the report include officer certifications pursuant to SEC rules and the Sarbanes-Oxley Act, along with XBRL data files[136](index=136&type=chunk)

Core Viewpoint - Agenus, a small-cap biotech company, experienced a significant share price increase of 40.8% without a clear catalyst, as investors anticipate a pivotal moment for the company related to its anti-cancer drug combination [1][2]. Company Overview - Agenus is focused on immuno-oncology, particularly its combination therapy of checkpoint inhibitors botensilimab (BOT) and balstilimab (BAL) for later-line metastatic microsatellite stable colorectal cancer [1][3]. - The company plans to file for approval of this combination by midyear, which is seen as a potential turning point for its market position [1]. Financial Potential - The BOT + BAL combination could generate annual sales between $250 million to nearly $1 billion, depending on pricing strategy, given the high average cost of cancer immunotherapy [3]. - Agenus currently has a market capitalization of $244 million, suggesting that even conservative revenue estimates indicate the stock may be undervalued [3][4]. Market Sentiment - The market appears to be pricing in a low expectation for the BOT + BAL combination, with assumptions that it may not exceed $80 million in annual sales, despite the significant unmet medical need in this area [4]. - Agenus has seven ongoing collaborations with major biopharma companies, but current investor focus is primarily on its internal pipeline [5]. Funding Challenges - Agenus faces challenges related to funding, as the costs of developing new cancer drugs and establishing a market presence are substantial [6]. - The company may need to continue raising capital through public offerings, which could dilute current shareholders and impact stock performance [6]. Investment Considerations - The potential reward from investing in Agenus may outweigh the risks, particularly if the anti-cancer compound proves successful [7]. - However, past experiences of near-commercial launches that did not materialize highlight the inherent uncertainties in the regulatory process [7].