Agenus (NASDAQ:AGEN) Stock

Agenus

Agenus Inc is an American clinical-stage company with a pipeline of therapies designed to activate the body's immune system to fight cancer and infections, including immune-modulatory antibodies, adoptive cell therapies through its subsidiary MiNK Therapeutics Inc. and vaccine adjuvants through its subsidiary SaponiQx Inc. This robust product pipeline is supported by company's in-house capabilities, including current good manufacturing practice (cGMP) manufacturing and a clinical operations platform. The company's antibody candidates are botensilimab (a proprietary next-generation Fc-engineered CTLA-4 antibody, also known as AGEN1811) and balstilimab (a PD-1 antibody).

Blockbuster Cancer Drug Opdivo Awaits Nod For 2 More Indications

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Agenus secures a $22M mortgage and announces a strategic realignment to focus on botensilimab/balstilimab in MSS colorectal cancer.

Agenus Gets $22M Mortgage, Plans Strategic Realignment To Focus On Colorectal Cancer Drug Development

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GSK&#39;s Respiratory Syncytial Virus Vaccine Given Together With Shingles Shot Shows Non-Inferior Immune Response In Older Adults

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Agenus reports that Bristol Myers Squibb (NYSE: BMY) is ending their 2021 agreement, returning the TIGIT bispecific antibody AGEN1777. This decision is part of Bristol Myers&#39; broader pipeline strategy adjustments.

Bristol Myers Squibb Terminates Cancer Drug Development Program With Agenus

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Incyte previously terminated the OX40 program (effective October 2023) and the GITR and an undisclosed program (effective May 2024). In July 2024, Incyte announced that it would discontinue development of its LAG-3 and TIM-3 programs.&nbsp;
With this termination, Agenus will regain full control of these assets and will evaluate future opportunities for their advancement, including internal development and potential new partnerships.
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Agenus Says Received Formal Notice On February 4 From Incyte Electing To Terminate Agreement Effective February 4, 2026, In Line With Strategic Portfolio Reprioritization; Upon Termination, All Rights To LAG-3 And TIM-3 Revert To Agenus

Agenus Publishes Data Of Study Of Botensilimab In Combination With Balstilimab In Patients With Relapsed/Refractory Metastatic Sarcomas In Journal of Clinical Oncology

HC Wainwright &amp; Co. analyst Emily Bodnar reiterates Agenus (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AGEN#NASDAQ">AGEN</a>) from Neutral to Neutral.

Reiteration

Analyst Ratings

HC Wainwright & Co. Reiterates Neutral on Agenusto Neutral

Agenus Announced Five Presentations Featuring Botensilimab (Bot, An Fc-enhanced Anti-CTLA-4 Antibody) Plus Balstilimab (Bal, An Anti-PD-1 Antibody) At The Upcoming American Society Of Clinical Oncology Gastrointestinal Cancers Symposium

This initiative follows the successful closing of a $22 million mortgage secured by key real estate assets, providing the company with enhanced operational flexibility during this pivotal period.&nbsp;
Key Measures Include:
<ul>
<li>Focusing on BOT/BAL: Agenus will concentrate its resources on its lead botensilimab/balstilimab (BOT/BAL) program, which has demonstrated robust clinical activity in microsatellite stable colorectal cancer (MSS CRC), non-small cell lung cancer (NSCLC), pancreatic cancer, sarcoma, and other difficult-to-treat cancers.</li>
<li>Reducing Costs: The company will implement significant cost-cutting measures, including staff reductions and operational adjustments, targeting a 60% reduction in annual expenditures and a cash burn of $100 million for FY 2025.</li>
<li>Optimizing Expert Manufacturing Capabilities: Agenus plans to transition its biologics CMC capabilities to a fee-for-service model, unlocking new revenue opportunities. This initiative is intended to be supported by external funding.</li>
</ul>

Agenus Announced Further Details Of Its Strategic Realignment, Reductions Are Designed To Reduce Cash Burn To $100M In FY 2025

HC Wainwright &amp; Co. analyst Emily Bodnar reiterates Agenus (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AGEN#NASDAQ">AGEN</a>) with a Neutral and maintains $7 price target.

Price Target

HC Wainwright & Co. Reiterates Neutral on Agenus, Maintains $7 Price Target

Agenus Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AGEN#NASDAQ">AGEN</a>) shares are trading higher<a target="_blank" href="https://www.benzinga.com/premarket" rel="noreferrer noopener"> in the morning session on Wednesday.</a>
The company has secured a $22 million non-amortizing mortgage, backed by its Berkeley-based Biologics CMC facility and its 66-acre <a target="_blank" href="https://www.benzinga.com/pressreleases/24/11/b42212789/agenus-secures-22-million-mortgage-and-announces-strategic-operational-realignment" rel="noreferrer noopener">biomanufacturing-zoned property in Vacaville, California.</a>
The deal, facilitated by L&amp;L Capital, provides $20 million in net proceeds after closing costs and interest reserve, boosting Agenus&#8217; cash position ahead of anticipated further cash infusions in the coming months.
The mortgage is structured with a two-year term, carrying interest rates of 12% for the first year and 13% for the second, with payments split 50% in cash and 50% in common stock.
In parallel, Agenus is executing a Strategic Operational Realignment Plan to focus its efforts on its promising botensilimab/balstilimab (BOT/BAL) in MSS colorectal cancer (CRC).
Also Read: <a target="_blank" href="https://www.benzinga.com/24/11/42210528/us-stock-futures-signal-a-muted-open-smallcaps-may-advance-analyst-flags-cross-asset-volatility" rel="noreferrer noopener">Major US Stock Futures Slide, Small-Caps Buck Trend: Market Strategist Flags This As The &#8216;Stronger Times Of The Year For Stocks&#8217;</a>
The plan includes a projected 60% reduction in annual external expenditures and a transition of the company&#8217;s CMC capabilities into a fee-for-service biologics manufacturing business. These measures, along with additional planned optimizations, are expected to reduce Agenus&#8217; FY 2025 cash burn to approximately $100 million.
BOT/BAL has demonstrated strong clinical activity in MSS CRC and other cancers resistant to existing therapies. Agenus is preparing for late-stage development and regulatory strategies, targeting both regional and global registration pathways. The company&#8217;s strategic realignment aims to revolutionize cancer treatment while positioning Agenus for long-term growth and patient impact.
Price Action: AGEN shares are trading higher by 16.3% to $3.93 at last check Wednesday.
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HC Wainwright &amp; Co. analyst Emily Bodnar maintains Agenus (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AGEN#NASDAQ">AGEN</a>) with a Neutral and lowers the price target from $8 to $7.

HC Wainwright & Co. Maintains Neutral on Agenus, Lowers Price Target to $7

Agenus (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AGEN#NASDAQ">AGEN</a>) reported quarterly losses of $(3.08) per share which missed the analyst consensus estimate of $(2.33) by 32.19 percent. This is a 6.38 percent increase over losses of $(3.29) per share from the same period last year. The company reported quarterly sales of $25.110 million which missed the analyst consensus estimate of $33.476 million by 24.99 percent. This is a 3.27 percent increase over sales of $24.314 million the same period last year.

Earnings

Earnings Misses

Agenus Q3 2024 GAAP EPS $(3.08) Misses $(2.33) Estimate, Sales $25.110M Miss $33.476M Estimate. Cash and Equivalents of $44.8M

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Earnings Scheduled For November 12, 2024

Agenus (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AGEN#NASDAQ">AGEN</a>) will release its quarterly earnings report on Tuesday, 2024-11-12. Here's a brief overview for investors ahead of the announcement.
Analysts anticipate Agenus to report an earnings per share (EPS) of $-2.33.
The market awaits Agenus's announcement, with hopes high for news of surpassing estimates and providing upbeat guidance for the next quarter.
It's important for new investors to understand that guidance can be a significant driver of stock prices.
<h3>Earnings History Snapshot</h3>
In the previous earnings release, the company missed EPS by $1.08, leading to a 3.6% drop in the share price the following trading session.
Here's a look at Agenus's past performance and the resulting price change:

<table>
<thead>
<tr>
<th>Quarter</th>
<th>Q2 2024</th>
<th>Q1 2024</th>
<th>Q4 2023</th>
<th>Q3 2023</th>
</tr>
</thead>
<tbody>
<tr>
<td>EPS Estimate</td>
<td>-1.44</td>
<td>-2.83</td>
<td>-1</td>
<td>-3.8</td>
</tr>
<tr>
<td>EPS Actual</td>
<td>-2.52</td>
<td>-3.04</td>
<td>-2.6</td>
<td>-3.2</td>
</tr>
<tr>
<td>Price Change %</td>
<td>-4.0%</td>
<td>-4.0%</td>
<td>-10.0%</td>
<td>2.0%</td>
</tr>
</tbody>
</table>

<img src="https://www.benzinga.com/files/images/story/2024/1731344491_0.png" alt="eps graph" />
<h3>Agenus Share Price Analysis</h3>
Shares of Agenus were trading at $3.905 as of November 08. Over the last 52-week period, shares are down 73.39%. Given that these returns are generally negative, long-term shareholders are likely bearish going into this earnings release. 
<a href="https://www.benzinga.com/quote/AGEN/earnings">To track all earnings releases for Agenus visit their earnings calendar on our site.</a>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Insights Ahead: Agenus's Quarterly Earnings

Novel Candidates Show Promise in Turning Cold and Refractory Tumors into Responsive Targets
Agenus Inc. ("Agenus") (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AGEN#NASDAQ">AGEN</a>), a leader in developing novel immunological agents to treat various cancers, today announced the presentation of new data on two of its promising investigational immunotherapy candidates, botensilimab and AGEN1721, at the Society for Immunotherapy of Cancer (SITC) 2024 Annual Meeting in Houston, Texas. The data, showcasing potential breakthroughs in treating immune-resistant tumors, will be presented by Dhan Chand, Ph.D., Vice President of Research at Agenus.

Agenus To Present Data On Botensilimab And AGEN1721 At SITC 2024; Novel Candidates Show Promise In Turning Cold And Refractory Tumors Into Responsive Targets

Wednesday, GSK plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) released topline data from the phase 3 trial in adults 50 years and older evaluating the immunogenicity, reactogenicity and safety of Arexvy (Respiratory Syncytial Virus Vaccine) when co-administered with <a target="_blank" href="https://www.benzinga.com/pressreleases/24/09/b40915839/gsk-announces-positive-topline-data-on-co-administration-of-arexvy-and-shingrix" rel="noreferrer noopener">Shingrix (Zoster Vaccine)</a>.
<ul>
<li>Shingrix is approved to prevent shingles (herpes zoster) in adults aged 50 and older.</li>
<li>Arexvy is approved for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in individuals 60 years of age and older and in individuals 50 through 59 who are at increased risk for LRTD caused by RSV.</li>
</ul>
The data were presented as a late-breaking abstract at the European Geriatric Medicine Society (EuGMS) Congress.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40817991/gsk-halts-herpes-simplex-virus-vaccine-development-clears-path-for-other-contenders-like-moderna-" rel="noreferrer noopener">GSK Halts Herpes Simplex Virus Vaccine Development, Clears Path For Other Contenders Like Moderna, BioNTech</a>.
The data showed a non-inferior immune response when the vaccines were co-administered compared to when they were administered at separate visits.
Co-administration was also well tolerated, with acceptable reactogenicity and safety profiles.
In both groups, the most frequently reported adverse events were pain at the injection site, fatigue, and myalgia.
The duration of solicited adverse events was comparable across the two groups.
Results from this trial will be submitted for peer-reviewed scientific publication and will be used to support regulatory submissions to the FDA, the European Medicines Agency, and other regulators.
Each year, approximately 177,000 adults 65 years and older are hospitalized in the US due to RSV, and an estimated 14,000 of those cases result in death.
Shingles is a painful, blistering rash caused by the reactivation of the varicella-zoster virus (VZV)—the same virus that causes chickenpox.&nbsp;An estimated one million people develop shingles annually in the US.
The GSK proprietary AS01 adjuvant system contains QS-21 STIMULON adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AGEN#NASDAQ">AGEN</a>).
Price Action: GSK stock is up 0.59% at $42.81 at the last check on Wednesday.
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GSK's Respiratory Syncytial Virus Vaccine Given Together With Shingles Shot Shows Non-Inferior Immune Response In Older Adults

BOT/BAL Demonstrates Broad and Durable Activity in Advanced Sarcoma Population

Events

Botensilimab/Balstilimab Presents Clinical Responses In Refractory Sarcomas At ESMO 2024

Agenus Inc. ("Agenus") (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AGEN#NASDAQ">AGEN</a>), a leader in developing novel immunological agents to treat various cancers, today announced that updated data from the clinical trial of botensilimab and balstilimab in refractory sarcomas will be featured in a mini oral presentation at the European Society for Medical Oncology (ESMO) Congress, taking place September 13-17, 2024, in Barcelona, Spain.
The presentation will feature updated efficacy and safety data from the large, ongoing Phase 1 trial, highlighting the potential of this combination therapy in treating patients with refractory sarcomas, including visceral angiosarcoma and leiomyosarcoma, populations with limited therapeutic options. Botensilimab, a novel investigational Fc-enhanced CTLA-4 inhibitor, and balstilimab, an investigational PD-1 antibody, have shown promising clinical responses in multiple tumor types, including "cold" tumors that are typically unresponsive to standard therapies.

Agenus to Present Cancer Therapy Data for Refractory Sarcomas at ESMO 2024

B. Riley Securities analyst Yuan Zhi maintains Agenus (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AGEN#NASDAQ">AGEN</a>) with a Buy and lowers the price target from $42 to $18.

B. Riley Securities Maintains Buy on Agenus, Lowers Price Target to $18

Agenus (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AGEN#NASDAQ">AGEN</a>) reported quarterly losses of $(2.52) per share which missed the analyst consensus estimate of $(1.07) by 135.51 percent. This is a 35.88 percent increase over losses of $(3.93) per share from the same period last year. The company reported quarterly sales of $23.509 million which missed the analyst consensus estimate of $61.477 million by 61.76 percent. This is a 7.06 percent decrease over sales of $25.296 million the same period last year.

Agenus Q2 2024 GAAP EPS $(2.52) Misses $(1.07) Estimate, Sales $23.509M Miss $61.477M Estimate

Antibody, Is Effective Against Tumors Poorly Responsive to Conventional Immunotherapy," highlights several key findings:
<ol>
<li>Demonstrated Activity Across Multiple Cancers: Botensilimab has shown increased activity in multiple treatment-resistant cancers, including those that have progressed on prior checkpoint inhibitors.</li>
<li>Fc-Enhanced Design for Multifunctional Immune Activation: Unlike traditional anti-CTLA-4 antibodies, botensilimab's Fc-enhanced design allows it to leverage multiple immune-activating mechanisms simultaneously. This includes enhanced T cell priming, reduction of intratumoral regulatory T cells, and activation of antigen-presenting cells, leading to a robust anti-tumor response.</li>
<li>Activity Independent of Conventional Limitations: Botensilimab shows clinical activity regardless of factors that typically limit conventional immunotherapy efficacy, such as tumor neoantigen burden and FcγRIIIA genotype. This broadens its potential applicability across diverse patient populations.</li>
<li>Remodeling the Tumor Microenvironment: The antibody uniquely remodels the tumor microenvironment, transforming "cold" tumors that are currently unresponsive to immune therapies into "hot" immunologically active tumors. This is achieved by reducing regulatory T cells and increasing T cell inflammation gene signatures within the tumor microenvironment.</li>
<li>Promise in Difficult-to-Treat Cancers: Botensilimab demonstrates significant promise in treating over nine difficult-to-treat cancers, including microsatellite stable colorectal cancer and may extend clinical benefits to patient populations historically unresponsive to conventional immune checkpoint inhibitors.</li>
</ol>

Agenus Publishes Seminal Study In Cancer Discovery Detailing Novel Mechanism And Effectiveness Of Botensilimab In Treatment-Resistant Cancers

In a&nbsp;regulatory filing&nbsp;Friday, Agenus Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AGEN#NASDAQ">AGEN</a>) revealed Bristol Myers Squibb &amp; Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) terminated a license, development, and commercialization agreement forged in 2021.
The company said that as part of a broader strategic realignment of their development pipeline, which involves other licensed products, Bristol Myers Squibb is <a target="_blank" href="https://www.sec.gov/ix?doc=/Archives/edgar/data/1098972/000095017024089932/agen-20240730.htm" rel="noreferrer noopener">returning</a> AGEN1777, a TIGIT bispecific antibody, to Agenus and voluntarily terminating the BMS License Agreement, effective as of January 26, 2025.
Related: <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/07/39864146/agenus-faces-regulatory-and-financial-challenges-analyst-downgrades-stock-pending-t" rel="noreferrer noopener">Agenus Faces Regulatory and Financial Challenges: Analyst Downgrades Stock Pending Trial Clarity</a>.
Most recently, Roche Holdings AG's (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) TIGIT drug, tiragolumab,&nbsp;failed in Phase 3 SKYSCRAPER-02 study in extensive-stage small-cell lung cancer (ES-SCLC) and did not meet its co-primary endpoint of <a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/39645630/roches-new-immunotherapy-fails-to-show-benefit-over-mercks-blockbuster-keytruda-in-lung-cancer-pa" rel="noreferrer noopener">progression-free survival</a>.
In August last year, Roche was made aware of the inadvertent disclosure of the second interim analysis of the Phase 3 SKYSCRAPER-01 study, evaluating tiragolumab plus Tecentriq (atezolizumab) versus Tecentriq alone as an initial (first-line) treatment for PD-L1-high locally advanced or metastatic&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/23/08/34010167/who-are-other-players-gaining-from-roches-accidental-lung-cancer-data-update" rel="noreferrer noopener">non-small cell lung cancer</a>.
In May, Merck &amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) discontinued the vibostolimab, its TIGIT drug, and pembrolizumab coformulation arm of the&nbsp;Phase 3 <a target="_blank" href="https://www.benzinga.com/general/biotech/24/05/38793420/merck-halts-skin-cancer-drug-trial-on-high-discontinuation-rate-a-setback-in-high-risk-melanoma-t" rel="noreferrer noopener">KeyVibe-010 trial</a>.&nbsp;
Results from Merck's Phase 2 KeyVibe-002 trial of vibostolimab/pembrolizumab combo, with or without docetaxel for metastatic non-small cell lung cancer with progressive disease after treatment with immunotherapy and&nbsp;platinum-doublet chemotherapy, did not show an improvement in median PFS <a target="_blank" href="https://www.benzinga.com/general/biotech/23/12/36132441/double-flops-for-mercks-lung-cancer-studies" rel="noreferrer noopener">compared to docetaxel alone</a>.
Bristol Myers acquired AGEN1777 in 2021 by paying Agenus $200 million in cash.
Price Action: AGEN stock is down 7.10% at $5.23 at last check Monday.
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Press Releases

Ligand Reports Third Quarter 2024 Financial Results and Raises 2024 Guidance

Agenus to Present Compelling Data on Botensilimab and AGEN1721 at SITC 2024

Agenus Reports Third Quarter 2024 Financial Results and Strategic Advancements in BOT/BAL Development

Agenus Secures $22 Million Mortgage and Announces Strategic Operational Realignment

Agenus Announces Strategic Realignment to Focus on Core Programs and Significantly Reduce Costs

Agenus Announces Five Presentations at ASCO GI Highlighting BOT/BAL Activity Across Colorectal and Gastric Cancers

Small Cap

Opinion

Oncology's Best Minds Set to Meet at Upcoming 2025 ASCO Gastrointestinal Cancers Symposium

Agenus Presents Data at ASCO GI Demonstrating Impact of BOT/BAL in Colorectal Cancer Across Neoadjuvant and Advanced Disease

Agenus Announces Publication in the Journal of Clinical Oncology Highlighting Data from Botensilimab Plus Balstilimab in Relapsed/Refractory Metastatic Sarcomas

Agenus' BOT/BAL Selected for Two Presentations at Upcoming AACR IO Annual Meeting

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