Agenus (AGEN) came out with a quarterly loss of $1.03 per share versus the Zacks Consensus Estimate of a loss of $1.61. This compares to loss of $3.04 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 36.02%. A quarter ago, it was expected that this biotechnology company would post a loss of $2.36 per share when it actually produced a loss of $2.04, delivering a surprise of 13.56%. Ahead of this earnings release, the estimate r ...

Agenus (AGEN) Q1 2025 Earnings Call May 12, 2025 08:30 AM ET Company Participants Zack Armen - Head of IR & Corporate DevelopmentDr. Garo Armen - Chairman & CEORichard Goldberg - Chief Development OfficerChristine Klaskin - Vice President of Finance, Principal Financial Officer & Principal Accounting OfficerSteven O’Day - Chief Medical OfficerJennifer Buell - Chairman & Executive CouncilMayank Mamtani - Senior Managing Director & Group Head of HealthcareMatt Phipps - Group Head - Biotechnology Conference Ca ...

Financial Data and Key Metrics Changes - The company ended Q1 2025 with a consolidated cash balance of $18.5 million, down from $40.4 million at the end of 2024 [23] - Cash used in operations for Q1 2025 was $25.6 million, reduced from $38.2 million for the same period in 2024 [23] - Revenue for Q1 2025 was $24.1 million, compared to $28 million in Q1 2024, with a net loss of $26.4 million or $1.03 per share, down from a net loss of $63.5 million or $3.04 per share in Q1 2024 [23] Business Line Data and Key Metrics Changes - The company is focusing on operational efficiencies to cut annualized operational cash burn to below $50 million in the second half of 2025 [20] - Four formal near-term transaction proposals have been received, including a facility sale and significant equity investment, aimed at strengthening the balance sheet [21][22] Market Data and Key Metrics Changes - Colorectal cancer incidences have doubled in U.S. adults aged 55 from 1995 to 2019, with projections indicating it will become the leading cause of cancer-related death in men by 2030 [7][8] - The company is addressing the urgent need for alternative treatments for colorectal cancer, particularly for younger patients who are increasingly affected [7][8] Company Strategy and Development Direction - The company is pursuing a Type B meeting with the FDA to discuss the potential accelerated approval of its product, BotBal, based on data from over 1,200 patients [25] - The new leadership, including Dr. Richard Goldberg, is expected to enhance the company's regulatory strategy and development focus on colorectal cancer and other solid tumors [15][19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the new regulatory environment under the current administration, which is expected to favor rapid approval of transformative therapies [10][11] - The company is committed to delivering meaningful treatments for patients, particularly in light of the increasing prevalence of colorectal cancer among younger demographics [19][20] Other Important Information - The company has received proposals for significant equity investments at a premium to the current share price, which could materially strengthen its financial position [21][22] - The company is also exploring licensing agreements that could provide upfront cash and royalties, further supporting its operational needs [59] Q&A Session Summary Question: What is the status of the Phase II study and overall survival endpoint? - Management indicated that they have approximately one more year of data from both Phase I and Phase II studies, with significant follow-up indicating potential survival benefits [31][34] Question: Are there any updates on the development plan in light of recent data? - The focus remains on colorectal cancer, particularly in refractory disease and the neoadjuvant setting, with plans to present data at an upcoming conference [46][47] Question: What is the strategy for sharing Phase II data with the market? - Management is open to sharing Phase II data in conjunction with the FDA meeting, emphasizing the importance of demonstrating safety and efficacy [72]

Financial Performance - Agenus reported Q1 2025 revenue of $24.1 million, a decrease of 13.6% from $28.0 million in Q1 2024[10] - The net loss for Q1 2025 was $26.4 million, or $1.03 per share, compared to a net loss of $63.5 million, or $3.04 per share in Q1 2024[10] - Cash used in operations decreased to $25.6 million in Q1 2025 from $38.2 million in the same period of 2024, reflecting a reduction of 32.9%[9] - Agenus ended Q1 2025 with a cash balance of $18.5 million, down from $40.4 million at the end of 2024[9] Clinical Developments - The BOT/BAL combination demonstrated breakthrough response rates in microsatellite stable (MSS) cancers, showing potential in previously hard-to-treat tumors[5] - 100% of dMMR CRC patients given a higher dose of BOT/BAL achieved pathological complete response (pCR)[12] - New data from the NEOASIS study indicated that BOT/BAL can induce pathological responses in various solid tumors beyond colorectal cancer[6] Strategic Initiatives - Agenus is on track to reduce its annualized operating cash burn below $50 million starting in the second half of 2025[8] - Dr. Richard Goldberg joined Agenus as Chief Development Officer to lead the advancement of BOT/BAL towards regulatory engagement[7] - A near-term capital transaction is expected to bolster the company's liquidity significantly[5]

Core Viewpoint - Agenus (AGEN) has experienced a decline of 7.9% over the past week, but the formation of a hammer chart pattern suggests potential support and a possible trend reversal in the future [1][2]. Technical Analysis - A hammer chart pattern indicates a minor difference between opening and closing prices, with a long lower wick, suggesting that the stock may have found support after a downtrend [3][4]. - The occurrence of a hammer pattern at the bottom of a downtrend signals that bears may have lost control, indicating a potential trend reversal [4]. Fundamental Analysis - There is rising optimism among Wall Street analysts regarding AGEN's future earnings, which enhances the prospects for a trend reversal [2][6]. - The consensus EPS estimate for the current year has increased by 7.4% over the last 30 days, indicating analysts' agreement on the company's potential for better earnings [7]. - AGEN holds a Zacks Rank of 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [8].

Financial Performance - Research and development revenue decreased to approximately $0.5 million in 2024 from $38.8 million in 2023, primarily due to a $25.0 million milestone earned in 2023 under the BMS License Agreement [440]. - Non-cash royalty revenue related to the sale of future royalties from GSK decreased by $13.6 million to approximately $101.0 million in 2024, down from $114.6 million in 2023, attributed to decreased net sales of GSK's vaccines containing the QS-21 STIMULON adjuvant [441][442]. - The accumulated deficit as of December 31, 2024, reached $2.18 billion, indicating significant losses since inception [438]. - R&D expenses decreased by 34% to $155.5 million for the year ended December 31, 2024, down from $234.6 million in 2023, primarily due to a $52.7 million decrease in third-party services and a $11.4 million decrease in personnel-related expenses [443]. - G&A expenses decreased by 9% to $71.9 million for the year ended December 31, 2024, from $78.7 million in 2023, mainly due to a $4.6 million decrease in personnel-related expenses and a $3.3 million decrease in subsidiary-related expenses [444]. - Non-operating income increased to $5.8 million for the year ended December 31, 2024, from $37,000 in 2023, primarily due to a $5.3 million gain on early lease terminations [446]. - Interest expense, net increased to $117.6 million for the year ended December 31, 2024, from $97.9 million in 2023, mainly due to increased non-cash interest related to the Royalty Purchase Agreement [447]. - The accumulated deficit reached $2.18 billion as of December 31, 2024, with significant losses expected to continue over the next several years [457]. - Cash, cash equivalents, and short-term investments decreased to $40.4 million as of December 31, 2024, down $35.7 million from the previous year [459]. - Net cash used in operating activities was $158.3 million for the year ended December 31, 2024, compared to $224.2 million in 2023 [465]. Debt and Financing - Long-term debt amounts to $37.459 billion, with $3.660 billion due in less than 1 year and $33.799 billion due in 1-3 years [467]. - The company raised approximately $2.01 billion through various financing activities since inception, including common and preferred stock sales [457]. - The company is in discussions for funding to support operations through the planned registration and launch strategy for its product candidates [462]. Clinical Development and Collaborations - The lead program, BOT, received Fast Track designation from the FDA in April 2023 for treating non-MSI-H and/or dMMR metastatic colorectal cancer [422]. - The company has established collaborations with several firms, including BMS, Gilead, and Merck, resulting in over a dozen antibody pre-clinical or clinical development programs [423]. - In 2024, Merck limited further clinical development of MK-4830 to a neoadjuvant ovarian study in combination with pembrolizumab and chemotherapy [426]. - The company is eligible to receive up to approximately $136.3 million and $49.4 million in potential development, regulatory, and commercial milestones from UroGen and Merck, respectively [432]. - MiNK Pharmaceuticals, a subsidiary, completed its IPO in October 2021 and is focused on developing allogeneic iNKT cell therapies, with a Phase 2 trial for agenT-797 actively enrolling [436]. - The company has entered into a Purchase and Sale Agreement with Ligand Pharmaceuticals, selling a portion of future milestone payments and royalties from various collaborations [432]. - The company aims to advance innovation in vaccine adjuvant discovery through its subsidiary SaponiQx, focusing on saponin-based adjuvants [433]. Operational and Investment Policies - Total payments estimated for third-party agreements related to clinical studies are projected to be $660.7 million, with $616.5 million expensed through December 31, 2024 [464]. - Cash and cash equivalents as of December 31, 2024, stand at $40.4 million, exposed to interest and foreign currency exchange rate changes [477]. - Approximately 2.1% of cash used in operations for the year ended December 31, 2024, was from foreign subsidiaries, indicating exposure to foreign currency exchange rate fluctuations [476]. - The company does not currently employ specific strategies to manage foreign currency exchange rate risks, such as derivatives or hedging [476]. - The investment policy aims to preserve principal, maintain liquidity, and maximize yields, prohibiting investments in structured vehicles and asset-backed commercial paper [478]. - Non-cash interest expense related to royalty financing transactions is recorded based on estimated royalty payments, which may vary due to several factors [473]. - The company is exposed to fluctuations in interest rates as it seeks debt financing and invests excess cash [477]. - The company periodically reviews and amends its investment policy as necessary to mitigate credit risk [478]. - The company has identified critical accounting policies that require complex judgments and estimates, which may differ from actual results [469].

Financial Data and Key Metrics Changes - The consolidated cash balance at the end of 2024 was $40.4 million, down from $76.1 million at the end of 2023 [17] - Cash used in operations for 2024 was $168 million, reduced from $224 million in the prior year [18] - Revenue for 2024 was $103.5 million, with a net loss of $232.3 million or $10.59 per share [18] - For Q4 2024, revenue was $26.8 million, with a net loss of $46.8 million or $2.04 per share [18] Business Line Data and Key Metrics Changes - The company has focused on reducing operational burn, achieving an annualized burn rate reduction to approximately $50 million by mid-2025 [6] - The primary focus remains on the development and registration of BOT/BAL, which has shown promising clinical activity in colorectal cancer [7][10] Market Data and Key Metrics Changes - BOT/BAL has demonstrated durable responses and prolonged survival in refractory microsatellite stable colorectal cancer, which accounts for over 90% of colorectal cancer cases [9][10] - The company is engaged in late-stage partnership discussions to secure funding for BOT/BAL development, particularly for neoadjuvant treatment of intermediate-stage colon and rectal cancers [15] Company Strategy and Development Direction - The company is strategically directing resources towards the development of BOT/BAL, with a commitment to groundbreaking treatments for patients [20][21] - Non-core assets are being monitored and monetized to fortify the balance sheet, including a high-value biologics manufacturing facility [15] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the financial position is tighter than ideal but is taking decisive actions to bolster cash position and contain costs [20] - There is significant external validation of BOT/BAL's clinical activity, which positions the company to advance its LEAD programs in 2025 and beyond [20][21] Other Important Information - The company has seen encouraging activity with BOT/BAL in combination with standard care treatments, indicating potential for organ-sparing options for patients [12][43] - Independent validation from leading global oncology centers is amplifying confidence in BOT/BAL's potential [14] Q&A Session Summary Question: Can you help frame the cost reductions, particularly which programs are impacted? - Cost reductions focus on non-essential headcount and external advisers, prioritizing BOT/BAL development [26] Question: What are the expected catalysts for 2025? - The company has shelved some pipeline products but can reignite them as needed, with regulatory updates anticipated [28] Question: How far along is the monetization of non-core assets? - The first stage of monetization involved obtaining a $20 million mortgage, with ongoing discussions for further monetization of manufacturing and real estate assets [34] Question: What could a registrational program look like? - The company has significant data supporting the efficacy of BOT/BAL in late-stage and neoadjuvant settings, with a clear path for potential approval [42]

Core Viewpoint - Agenus reported a quarterly loss of $2.04 per share, which was better than the Zacks Consensus Estimate of a loss of $2.36, indicating an earnings surprise of 13.56% [1] - The company’s revenues for the quarter were $26.84 million, missing the Zacks Consensus Estimate by 20.21% and significantly down from $83.8 million a year ago [2] Company Performance - Over the last four quarters, Agenus has surpassed consensus EPS estimates two times, but has not beaten revenue estimates during the same period [2] - The stock has declined approximately 21.5% since the beginning of the year, contrasting with the S&P 500's decline of 4.5% [3] Future Outlook - The company's earnings outlook is crucial for investors, with current consensus EPS estimates at -$1.91 for the coming quarter and -$7.16 for the current fiscal year [7] - The estimate revisions trend for Agenus is currently favorable, resulting in a Zacks Rank 2 (Buy), suggesting the stock is expected to outperform the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Agenus belongs, is currently ranked in the top 29% of over 250 Zacks industries, indicating a positive outlook for stocks within this sector [8] - Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact stock performance [5]

Financial Performance - Agenus Inc. reported financial results for Q4 and the year ended December 31, 2024[6] - The company issued a press release on March 11, 2025, detailing its financial performance[6] - Specific financial metrics and user data were not provided in the available content[6]

Group 1 - Momentum investing contrasts with the traditional "buy low and sell high" strategy, focusing instead on "buying high and selling higher" to capitalize on fast-moving stocks [1] - Identifying the right entry point for trending stocks can be challenging, as they may lose momentum if future growth does not justify their high valuations [1] - A safer investment approach involves targeting bargain stocks that exhibit recent price momentum, utilizing tools like the Zacks Momentum Style Score [2] Group 2 - Agenus (AGEN) is highlighted as a strong candidate for investment, showing a four-week price change of 14.7%, indicating growing investor interest [3] - AGEN has demonstrated significant long-term momentum, with a 28.7% price increase over the past 12 weeks and a beta of 1.31, suggesting it moves 31% more than the market [4] - The stock has a Momentum Score of B, indicating a favorable time for investment to leverage its momentum [5] Group 3 - AGEN's upward trend in earnings estimate revisions has contributed to its Zacks Rank 2 (Buy), which is associated with strong momentum effects [6] - The stock is currently trading at a Price-to-Sales ratio of 0.57, indicating it is undervalued at 57 cents for each dollar of sales [6] - AGEN is positioned for further growth, with potential for fast-paced performance [7]