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2026-08-07
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Earnings documents stored for AGEN.

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Investor releaseQuarter not tagged2026-08-07

Agenus: Q2 Earnings Snapshot

Associated Press

LEXINGTON, Mass. (AP) — LEXINGTON, Mass. (AP) — Agenus Inc. (AGEN) on Friday reported a loss of $550,000 in its second quarter. The Lexington, Massachusetts-based company said it had a loss of 1 cent per share. The biotechnology company posted revenue of $34.5 million in the period. Agenus shares have more than doubled since the beginning of the year. In the final minutes of trading on Friday, shares hit $6.96, an increase of 46% in the last 12 months. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on AGEN at https://www.zacks.com/ap/AGEN

Investor releaseQuarter not tagged2026-08-06

Agenus Reports Second Quarter 2026 Results and Advances Phase 3 ROBBIN Trial of BOT+BAL in Neoadjuvant MSS Colon Cancer

Business Wire
Previously announced oversubscribed $85 million private placement, with up to an additional $255 million in potential proceeds from milestone-aligned warrants, supports ROBBIN execution ROBBIN addresses approximately 38,000 newly diagnosed U.S. patients annually and an estimated annual U.S. sales opportunity of more than $7 billion; initiation and first patient dosing are expected in the first quarter of 2027 Previously reported NEST and UNICORN findings provided the direct clinical rationale for ROBBIN; recent advanced-disease updates reinforce the durability of BOT+BAL activity BOT+BAL access programs expanded across additional countries and treating institutions, contributing $6.4 million in second-quarter pre-commercial product revenue LEXINGTON, Mass., August 06, 2026--(BUSINESS WIRE)--Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today reported financial results for the second quarter ended June 30, 2026, and provided an update on its financing-supported strategy to advance botensilimab (BOT), a multifunctional, Fc-enhanced anti-CTLA-4 antibody, plus balstilimab (BAL), an anti-PD-1 antibody, in a curative-intent treatment setting before surgery in high-risk, resectable microsatellite-stable (MSS) colon cancer. As previously announced, Agenus completed an oversubscribed private placement in July 2026 structured to support ROBBIN, its planned global registrational Phase 3 trial of neoadjuvant (before surgery) BOT+BAL in patients with high-risk Stage II and Stage III microsatellite-stable (MSS) colon cancer. MSS disease accounts for approximately 85% of early-stage colorectal cancers. In the population targeted by ROBBIN, treatment remains centered on surgery followed by chemotherapy or observation, with no new curative-intent therapies approved in more than 20 years.i,ii The decision to accelerate ROBBIN is grounded in previously reported findings from the independent NEST and UNICORN studies evaluating neoadjuvant BOT+BAL treatment in patients with Stage II and Stage III MSS colorectal cancer. Treatment before surgery produced deep pathologic responses, while recent advanced-disease updates provide complementary evidence of durable BOT+BAL immune activity. ROBBIN addresses an estimated 38,000 newly diagnosed patients annually in the United States and more than 200,000 worldwide.iii Agenus estimates that this population represents a…Read full document

Previously announced oversubscribed $85 million private placement, with up to an additional $255 million in potential proceeds from milestone-aligned warrants, supports ROBBIN execution ROBBIN addresses approximately 38,000 newly diagnosed U.S. patients annually and an estimated annual U.S. sales opportunity of more than $7 billion; initiation and first patient dosing are expected in the first quarter of 2027 Previously reported NEST and UNICORN findings provided the direct clinical rationale for ROBBIN; recent advanced-disease updates reinforce the durability of BOT+BAL activity BOT+BAL access programs expanded across additional countries and treating institutions, contributing $6.4 million in second-quarter pre-commercial product revenue LEXINGTON, Mass., August 06, 2026--(BUSINESS WIRE)--Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today reported financial results for the second quarter ended June 30, 2026, and provided an update on its financing-supported strategy to advance botensilimab (BOT), a multifunctional, Fc-enhanced anti-CTLA-4 antibody, plus balstilimab (BAL), an anti-PD-1 antibody, in a curative-intent treatment setting before surgery in high-risk, resectable microsatellite-stable (MSS) colon cancer. As previously announced, Agenus completed an oversubscribed private placement in July 2026 structured to support ROBBIN, its planned global registrational Phase 3 trial of neoadjuvant (before surgery) BOT+BAL in patients with high-risk Stage II and Stage III microsatellite-stable (MSS) colon cancer. MSS disease accounts for approximately 85% of early-stage colorectal cancers. In the population targeted by ROBBIN, treatment remains centered on surgery followed by chemotherapy or observation, with no new curative-intent therapies approved in more than 20 years.i,ii The decision to accelerate ROBBIN is grounded in previously reported findings from the independent NEST and UNICORN studies evaluating neoadjuvant BOT+BAL treatment in patients with Stage II and Stage III MSS colorectal cancer. Treatment before surgery produced deep pathologic responses, while recent advanced-disease updates provide complementary evidence of durable BOT+BAL immune activity. ROBBIN addresses an estimated 38,000 newly diagnosed patients annually in the United States and more than 200,000 worldwide.iii Agenus estimates that this population represents an annual addressable sales opportunity of more than $7 billion. "The financing completed in July gives us a clear path to act on the clinical evidence supporting BOT+BAL in a large, underserved patient population," said Garo H. Armen, Ph.D., Chairman and Chief Executive Officer of Agenus. "The previously reported neoadjuvant findings support testing whether BOT+BAL before surgery can reduce recurrence and improve the potential for cure. With capital aligned to ROBBIN’s development milestones, we are positioned to pursue that opportunity with focus and urgency." Previously Announced Financing Supports ROBBIN Execution The private placement, announced and completed in July, provided approximately $85 million in upfront gross proceeds and included milestone-aligned warrants that could provide up to approximately $255 million in additional gross proceeds if fully exercised. The warrant structure aligns potential additional capital with planned ROBBIN milestones. Based on the company’s current operating plan, the upfront proceeds are expected to support ROBBIN initiation, regulatory alignment and company operations through Q3 2027. Assuming full exercise of the warrants, the financing is expected to support the planned ROBBIN program and company operations through year-end 2031. Agenus continues to implement disciplined cost-management measures and is directing internal resources toward ROBBIN execution, clinical and access-program supply, regulatory activities and supporting data generation. Clinical Evidence Reinforces BOT+BAL’s Differentiated Profile Previously reported findings from the independent NEST and UNICORN studies provide the direct neoadjuvant clinical rationale for ROBBIN in Stage II and Stage III MSS colon cancer. Among 38 BOT+BAL-treated patients, approximately 30% achieved a pathologic complete response (pCR; no viable tumor found at surgery), and approximately 40% achieved a major pathologic response (MPR; 10% or less viable tumor remaining). At the applicable data cutoffs, no disease recurrences had been reported. Manuscripts with longer-term follow-up from both studies are anticipated in the second half of 2026. Recent advanced-disease updates further reinforced the durability of BOT+BAL activity. At ESMO Gastrointestinal Cancers Congress 2026, follow-up from the fully enrolled 123-patient Phase 1b cohort in refractory MSS metastatic colorectal cancer without active liver metastases showed median overall survival of 21.2 months and three-year overall survival of 33%. At last follow-up, 17% of patients were alive and off all systemic cancer therapy. No new safety signals or treatment-related deaths were reported. During the quarter, durable BOT+BAL activity was also reported in checkpoint-refractory melanoma and post-immunotherapy hepatocellular carcinoma, further supporting the combination’s activity across tumors that had resisted prior immunotherapy or multiple lines of treatment. Expanding Patient Access and Supporting Treatment Continuity Agenus broadened authorized access to BOT+BAL during the second quarter through France’s national Autorisation d’Accès Compassionnel (AAC) program and physician-led paid named-patient programs in additional countries. The programs now span a broader network of countries, treating institutions and healthcare professionals. Agenus recognized $6.4 million in pre-commercial product revenue from authorized access programs during the second quarter, compared with $4.6 million in the first quarter of 2026. As Agenus concentrates its development resources on ROBBIN, the access programs enable the company to continue supporting eligible patients with advanced disease, sustain engagement with experienced treating physicians and advance its neoadjuvant registrational strategy. As part of prioritizing resources toward the ROBBIN trial, Agenus discontinued its planned future funding commitment to BATTMAN, the Phase 3 study sponsored by the Canadian Cancer Trials Group (CCTG) evaluating BOT+BAL in refractory MSS metastatic colorectal cancer. Agenus was one of the study’s funding sources and supplied BOT+BAL, while CCTG sponsored and conducted the trial. Following Agenus’s funding decision, CCTG formally terminated the study. The decision reflected financing and development priorities and was not driven by enrollment performance, efficacy or safety findings. Agenus remains committed to supporting continued BOT+BAL treatment for patients already enrolled in BATTMAN when medically appropriate and permitted under applicable requirements. In France, eligible patients may continue to access BOT+BAL through the established national AAC program. Agenus has also established physician-led compassionate-access pathways in Canada, Australia and New Zealand, the other countries in which BATTMAN had been planned to enroll patients. The pathways in Canada, Australia and New Zealand will remain open to new physician requests through December 31, 2026. Second Quarter 2026 Financial Results Revenue Total revenue for the second quarter of 2026 was $34.5 million, compared with $25.7 million a year earlier. This included $6.4 million in pre-commercial BOT+BAL product revenue from authorized patient-access programs and $28.1 million in non-cash royalty revenue, up from $24.8 million. Non-cash royalty revenue relates to royalty interests Agenus previously monetized and does not provide cash to the company. Total revenue for the first six months of 2026 was $68.3 million, compared with $49.8 million a year earlier, including $11.0 million in pre-commercial product revenue and $57.3 million in non-cash royalty revenue. Near-Term Milestones Manuscripts with longer-term follow-up from NEST and UNICORN anticipated in the second half of 2026 Investigator-sponsored BOT+BAL presentations at ESMO 2026 ROBBIN initiation and first patient dosing anticipated in the first quarter of 2027 Corporate Webcast Information Agenus will host a corporate strategy webcast, including a live question-and-answer session, on Thursday, September 10, 2026, at 4:30 p.m. ET. Following the company’s recent financing webcast, the September event will provide a more comprehensive discussion of Agenus’s corporate priorities, including the acceleration of BOT+BAL in neoadjuvant colon cancer through ROBBIN, upcoming clinical and data milestones, and ongoing patient-access efforts. The webcast was previously anticipated for late August; the revised timing allows for broader speaker participation and a more substantive strategic discussion. Additional details, including the agenda and access information, will be announced prior to the event. About Agenus Agenus is a clinical-stage immuno-oncology company advancing a pipeline of antibody-based programs designed to activate innate and adaptive immunity, overcome tumor immune evasion, and expand the population of patients who may benefit from immunotherapy. Founded in 1994, Agenus’ lead program is botensilimab plus balstilimab (BOT+BAL), a next-generation combination of a multifunctional, Fc-enhanced anti-CTLA-4 antibody and an anti-PD-1 antibody that has been evaluated in approximately 1,300 patients across nine tumor types. Agenus secured dedicated long-term U.S. biologics manufacturing capacity through its strategic collaboration with Zydus Lifesciences, which closed in January 2026 and included the sale of Agenus’ Emeryville and Berkeley manufacturing facilities to Zydus. Agenus also holds an equity investment in MiNK Therapeutics, Inc. (Nasdaq: INKT), a clinical-stage developer of allogeneic invariant natural killer T cell therapies, and a majority interest in SaponiQx, Inc., a vaccine adjuvant business. Agenus is headquartered in Lexington, Massachusetts. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on the Company’s website and social media channels. About the ROBBIN Phase 3 Trial ROBBIN is planned as a global, randomized Phase 3 trial evaluating a short course of BOT+BAL before surgery in approximately 850 previously untreated patients with high-risk Stage II and Stage III microsatellite-stable (MSS) colon cancer. The trial is designed to randomize patients 1:1 to receive neoadjuvant BOT+BAL followed by surgery or surgery followed by standard-of-care management alone. ROBBIN will assess whether neoadjuvant BOT+BAL can reduce the risk of recurrence compared with surgery followed by standard-of-care management alone. Event-free survival is planned as the primary endpoint. Key elements of the trial design, including the proposed patient population, treatment arms, primary endpoint and interim-analysis approach, have been informed by feedback from the U.S. Food and Drug Administration. Agenus’ Commitment to Patient Access Until marketing authorization is granted, BOT+BAL is accessible only through clinical trials and authorized early access mechanisms where permitted and available under each country’s regulatory framework. For eligible French patients treated in hospital under AAC and meeting the predefined criteria, BOT+BAL is fully reimbursed by France’s national health system. Outside France, access may be available in select countries through paid named-patient programs, which may involve out-of-pocket costs to the patient or coverage under applicable national or private reimbursement arrangements. These programs are physician-driven and are not promotional. About Botensilimab (BOT) Botensilimab (BOT) is a human, multifunctional, Fc-enhanced anti-CTLA-4 antibody designed to activate innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Approximately 1,300 patients have been treated with botensilimab and/or balstilimab in Phase 1 and Phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov. About Balstilimab (BAL) Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding Agenus’ botensilimab and balstilimab programs, access programs, clinical development plans, expected regulatory timelines and filings, manufacturing readiness, operating expense reductions, liquidity, anticipated cash runway, the Company’s need for additional capital, the exercise of the Series A and Series B warrants, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," "potential," and similar expressions intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of Agenus’ most recent Annual Report on Form 10-K for 2025 and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Referencesi Buchler T. Front Oncol. 2022;12:888181.ii Guven DC, et al. Oncologist. 2024;29(5):e580-e600.iii Epidemiology analysis based on data from SEER, CDC, and Clarivate View source version on businesswire.com: https://www.businesswire.com/news/home/20260806376413/en/ Contacts Investors: 917-362-1370 | [email protected] Media: 781-674-4422 | [email protected]

Investor releaseQuarter not tagged2026-07-30

Agenus (AGEN) Earnings Expected to Grow: Should You Buy?

Zacks
The market expects Agenus (AGEN) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The earnings report, which is expected to be released on August 6, might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This biotechnology company is expected to post quarterly earnings of $0.05 per share in its upcoming report, which represents a year-over-year change of +105%. Revenues are expected to be $34 million, up 32.3% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 40% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's p…Read full document

The market expects Agenus (AGEN) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended June 2026. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The earnings report, which is expected to be released on August 6, might help the stock move higher if these key numbers are better than expectations. On the other hand, if they miss, the stock may move lower. While management's discussion of business conditions on the earnings call will mostly determine the sustainability of the immediate price change and future earnings expectations, it's worth having a handicapping insight into the odds of a positive EPS surprise. This biotechnology company is expected to post quarterly earnings of $0.05 per share in its upcoming report, which represents a year-over-year change of +105%. Revenues are expected to be $34 million, up 32.3% from the year-ago quarter. The consensus EPS estimate for the quarter has been revised 40% lower over the last 30 days to the current level. This is essentially a reflection of how the covering analysts have collectively reassessed their initial estimates over this period. Investors should keep in mind that the direction of estimate revisions by each of the covering analysts may not always get reflected in the aggregate change. Price, Consensus and EPS Surprise Estimate revisions ahead of a company's earnings release offer clues to the business conditions for the period whose results are coming out. Our proprietary surprise prediction model -- the Zacks Earnings ESP (Expected Surprise Prediction) -- has this insight at its core. The Zacks Earnings ESP compares the Most Accurate Estimate to the Zacks Consensus Estimate for the quarter; the Most Accurate Estimate is a more recent version of the Zacks Consensus EPS estimate. The idea here is that analysts revising their estimates right before an earnings release have the latest information, which could potentially be more accurate than what they and others contributing to the consensus had predicted earlier. Thus, a positive or negative Earnings ESP reading theoretically indicates the likely deviation of the actual earnings from the consensus estimate. However, the model's predictive power is significant for positive ESP readings only. A positive Earnings ESP is a strong predictor of an earnings beat, particularly when combined with a Zacks Rank #1 (Strong Buy), 2 (Buy) or 3 (Hold). Our research shows that stocks with this combination produce a positive surprise nearly 70% of the time, and a solid Zacks Rank actually increases the predictive power of Earnings ESP. Please note that a negative Earnings ESP reading is not indicative of an earnings miss. Our research shows that it is difficult to predict an earnings beat with any degree of confidence for stocks with negative Earnings ESP readings and/or Zacks Rank of 4 (Sell) or 5 (Strong Sell). For Agenus, the Most Accurate Estimate is the same as the Zacks Consensus Estimate, suggesting that there are no recent analyst views which differ from what have been considered to derive the consensus estimate. This has resulted in an Earnings ESP of 0%. On the other hand, the stock currently carries a Zacks Rank of #3. So, this combination makes it difficult to conclusively predict that Agenus will beat the consensus EPS estimate. Analysts often consider to what extent a company has been able to match consensus estimates in the past while calculating their estimates for its future earnings. So, it's worth taking a look at the surprise history for gauging its influence on the upcoming number. For the last reported quarter, it was expected that Agenus would post earnings of $2.1 per share when it actually produced earnings of $1.02, delivering a surprise of -51.43%. Over the last four quarters, the company has beaten consensus EPS estimates just once. An earnings beat or miss may not be the sole basis for a stock moving higher or lower. Many stocks end up losing ground despite an earnings beat due to other factors that disappoint investors. Similarly, unforeseen catalysts help a number of stocks gain despite an earnings miss. That said, betting on stocks that are expected to beat earnings expectations does increase the odds of success. This is why it's worth checking a company's Earnings ESP and Zacks Rank ahead of its quarterly release. Make sure to utilize our Earnings ESP Filter to uncover the best stocks to buy or sell before they've reported. Agenus doesn't appear a compelling earnings-beat candidate. However, investors should pay attention to other factors too for betting on this stock or staying away from it ahead of its earnings release. Another stock from the Zacks Medical - Biomedical and Genetics industry, Tarsus Pharmaceuticals, Inc. (TARS), is soon expected to post loss of $0.21 per share for the quarter ended June 2026. This estimate indicates a year-over-year change of +56.3%. Revenues for the quarter are expected to be $165.62 million, up 61.3% from the year-ago quarter. Over the last 30 days, the consensus EPS estimate for Tarsus Pharmaceuticals has been revised 439.7% down to the current level. Nevertheless, the company now has an Earnings ESP of -6.13%, reflecting a lower Most Accurate Estimate. When combined with a Zacks Rank of #4 (Sell), this Earnings ESP makes it difficult to conclusively predict that Tarsus Pharmaceuticals will beat the consensus EPS estimate. Over the last four quarters, the company surpassed consensus EPS estimates two times. Stay on top of upcoming earnings announcements with the Zacks Earnings Calendar. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Agenus Inc. (AGEN) : Free Stock Analysis Report Tarsus Pharmaceuticals, Inc. (TARS) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-07-28

Agenus to Provide Second Quarter 2026 Financial Report and Development Update

Business Wire
LEXINGTON, Mass., July 28, 2026--(BUSINESS WIRE)--Agenus Inc. ("Agenus") (Nasdaq: AGEN), a leader in immuno-oncology, today announced that the Company will release its second quarter 2026 financial results before the market opens on Thursday, August 6, 2026. Agenus plans to host a webcast later in August to discuss its corporate priorities, including the acceleration of the botensilimab and balstilimab (BOT+BAL) immunotherapy combination in the neoadjuvant colon cancer setting through the Phase 3 ROBBIN trial, upcoming clinical and data milestones, and ongoing efforts to support patient access to BOT+BAL. Additional details, including the webcast agenda and access information, will be provided prior to the event. About Agenus Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants. Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. About Botensilimab (BOT) Botensilimab (BOT) is a human Fc enhanced multifunctional anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Approximately 1,300 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical response…Read full document

LEXINGTON, Mass., July 28, 2026--(BUSINESS WIRE)--Agenus Inc. ("Agenus") (Nasdaq: AGEN), a leader in immuno-oncology, today announced that the Company will release its second quarter 2026 financial results before the market opens on Thursday, August 6, 2026. Agenus plans to host a webcast later in August to discuss its corporate priorities, including the acceleration of the botensilimab and balstilimab (BOT+BAL) immunotherapy combination in the neoadjuvant colon cancer setting through the Phase 3 ROBBIN trial, upcoming clinical and data milestones, and ongoing efforts to support patient access to BOT+BAL. Additional details, including the webcast agenda and access information, will be provided prior to the event. About Agenus Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants. Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. About Botensilimab (BOT) Botensilimab (BOT) is a human Fc enhanced multifunctional anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Approximately 1,300 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov. About Balstilimab (BAL) Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," "establish," "potential," "superiority," "best in class," and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2025, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. View source version on businesswire.com: https://www.businesswire.com/news/home/20260728926096/en/ Contacts Investors: 917-362-1370 | [email protected] Media: 781-674-4422 | [email protected]

Investor releaseQuarter not tagged2026-06-10

Why Is Agenus (AGEN) Down 9.6% Since Last Earnings Report?

Zacks
A month has gone by since the last earnings report for Agenus (AGEN). Shares have lost about 9.6% in that time frame, underperforming the S&P 500. But investors have to be wondering, will the recent negative trend continue leading up to its next earnings release, or is Agenus due for a breakout? Well, first let's take a quick look at its latest earnings report in order to get a better handle on the recent catalysts for Agenus Inc. before we dive into how investors and analysts have reacted as of late. Agenus reported first-quarter 2026 earnings of $1.02 per share, missing the Zacks Consensus Estimate of $2.10. A year ago, the company reported a loss of $1.03. The quarter’s revenues totaled $33.7 million, which missed the consensus mark of $129.5 million. The figure, however, rose 40% year over year, supported by BOT+BAL activity through authorized access pathways. In the first quarter, Agenus posted pre-commercial product revenues of $4.6 million, representing realized income from BOT+BAL provided to hospitals and treating physicians under regulatory-authorized early access pathways, including France’s AAC framework and paid named-patient programs where permitted. Non-cash royalty revenues were $29.1 million compared with $23.6 million in the year-ago quarter. The company reported operating income of $15.1 million and net income of $39.2 million in the quarter. Cash and cash equivalents totaled $35 million at March 31, 2026 compared with $3 million in the previous quarter. After quarter-end, Agenus received an additional $11.7 million in net proceeds from sales of common stock under its at-the-market offering program, and it also expects to collect outstanding receivables tied to authorized early access programs during the second quarter. It turns out, fresh estimates have trended upward during the past month. The consensus estimate has shifted 118.75% due to these changes. Currently, Agenus has a average Growth Score of C, though it is lagging a bit on the Momentum Score front with a D. However, the stock was allocated a grade of B on the value side, putting it in the top 40% for value investors. Overall, the stock has an aggregate VGM Score of B. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been trending upward for the stock, and the magnitude of this revision looks promising. Notably, Agenus has…Read full document

A month has gone by since the last earnings report for Agenus (AGEN). Shares have lost about 9.6% in that time frame, underperforming the S&P 500. But investors have to be wondering, will the recent negative trend continue leading up to its next earnings release, or is Agenus due for a breakout? Well, first let's take a quick look at its latest earnings report in order to get a better handle on the recent catalysts for Agenus Inc. before we dive into how investors and analysts have reacted as of late. Agenus reported first-quarter 2026 earnings of $1.02 per share, missing the Zacks Consensus Estimate of $2.10. A year ago, the company reported a loss of $1.03. The quarter’s revenues totaled $33.7 million, which missed the consensus mark of $129.5 million. The figure, however, rose 40% year over year, supported by BOT+BAL activity through authorized access pathways. In the first quarter, Agenus posted pre-commercial product revenues of $4.6 million, representing realized income from BOT+BAL provided to hospitals and treating physicians under regulatory-authorized early access pathways, including France’s AAC framework and paid named-patient programs where permitted. Non-cash royalty revenues were $29.1 million compared with $23.6 million in the year-ago quarter. The company reported operating income of $15.1 million and net income of $39.2 million in the quarter. Cash and cash equivalents totaled $35 million at March 31, 2026 compared with $3 million in the previous quarter. After quarter-end, Agenus received an additional $11.7 million in net proceeds from sales of common stock under its at-the-market offering program, and it also expects to collect outstanding receivables tied to authorized early access programs during the second quarter. It turns out, fresh estimates have trended upward during the past month. The consensus estimate has shifted 118.75% due to these changes. Currently, Agenus has a average Growth Score of C, though it is lagging a bit on the Momentum Score front with a D. However, the stock was allocated a grade of B on the value side, putting it in the top 40% for value investors. Overall, the stock has an aggregate VGM Score of B. If you aren't focused on one strategy, this score is the one you should be interested in. Estimates have been trending upward for the stock, and the magnitude of this revision looks promising. Notably, Agenus has a Zacks Rank #3 (Hold). We expect an in-line return from the stock in the next few months. Agenus belongs to the Zacks Medical - Biomedical and Genetics industry. Another stock from the same industry, Royalty Pharma (RPRX), has gained 7.6% over the past month. More than a month has passed since the company reported results for the quarter ended March 2026. Royalty Pharma reported revenues of $925 million in the last reported quarter, representing a year-over-year change of +10.3%. EPS of $1.30 for the same period compares with $1.06 a year ago. For the current quarter, Royalty Pharma is expected to post earnings of $1.27 per share, indicating a change of +11.4% from the year-ago quarter. The Zacks Consensus Estimate remained unchanged over the last 30 days. Royalty Pharma has a Zacks Rank #3 (Hold) based on the overall direction and magnitude of estimate revisions. Additionally, the stock has a VGM Score of C. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Agenus Inc. (AGEN) : Free Stock Analysis Report Royalty Pharma PLC (RPRX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-05-29

IBRX Stock Outlook After Q1 Results and a New FDA Review

Zacks
ImmunityBio IBRX enters the post-earnings stretch with the stock at $7.72 (as of May 28, 2026) and a six to12 month price target of $8.25. After a 289.9% year-to-date surge, the setup is less about “what’s next” and more about what has already been priced in. The base case is an in-line performance profile tied to Anktiva’s commercial trajectory, with near-term upside requiring continued proof that demand is still accelerating after the run. IBRX has already delivered a sharp rerating, and the valuation reflects it. The shares are trading at 23.41x forward twelve-month sales versus 1.96x for the Zacks sub-industry, 2.12x for the Zacks sector and 5.25x for the S&P 500. That gap raises the bar for execution, especially for a company whose revenue base is still concentrated in a single marketed product. Against that backdrop, the $8.25 six to 12 month price target implies a more measured path from here. For investors, the practical question is whether the next few quarters extend the current adoption trend enough to justify what the market is already discounting after the stock’s outsized move. First-quarter 2026 results landed as a modest earnings miss with a revenue beat. ImmunityBio posted an adjusted loss of 9 cents per share versus the consensus loss of 8 cents, while revenue came in at $44.2 million versus $41.1 million. The adjusted figure excluded a large one-time fair-value change tied to warrant and derivative liabilities as well as the related-party convertible note. Including that line item, loss per share was 62 cents, compared with 15 cents a year ago. In other words, the quarter was not clean, but the core takeaway stayed centered on whether Anktiva’s commercial ramp remains intact. The quarter reinforced a demand narrative that is increasingly about breadth, not just initial uptake. Management pointed to strong demand from new prescribers and broader use across eligible patients, including in the maintenance setting. That matters because repeat ordering is the clearest sign that early trial use is translating into routine practice. Management framed repeat ordering as a driver of continued momentum, supporting quarter-over-quarter growth since launch. ImmunityBio, Inc. price | ImmunityBio, Inc. Quote The commercial build is showing up in operating expenses. Research and development expense rose to $68 million from $48.2 million a year earlier, d…Read full document

ImmunityBio IBRX enters the post-earnings stretch with the stock at $7.72 (as of May 28, 2026) and a six to12 month price target of $8.25. After a 289.9% year-to-date surge, the setup is less about “what’s next” and more about what has already been priced in. The base case is an in-line performance profile tied to Anktiva’s commercial trajectory, with near-term upside requiring continued proof that demand is still accelerating after the run. IBRX has already delivered a sharp rerating, and the valuation reflects it. The shares are trading at 23.41x forward twelve-month sales versus 1.96x for the Zacks sub-industry, 2.12x for the Zacks sector and 5.25x for the S&P 500. That gap raises the bar for execution, especially for a company whose revenue base is still concentrated in a single marketed product. Against that backdrop, the $8.25 six to 12 month price target implies a more measured path from here. For investors, the practical question is whether the next few quarters extend the current adoption trend enough to justify what the market is already discounting after the stock’s outsized move. First-quarter 2026 results landed as a modest earnings miss with a revenue beat. ImmunityBio posted an adjusted loss of 9 cents per share versus the consensus loss of 8 cents, while revenue came in at $44.2 million versus $41.1 million. The adjusted figure excluded a large one-time fair-value change tied to warrant and derivative liabilities as well as the related-party convertible note. Including that line item, loss per share was 62 cents, compared with 15 cents a year ago. In other words, the quarter was not clean, but the core takeaway stayed centered on whether Anktiva’s commercial ramp remains intact. The quarter reinforced a demand narrative that is increasingly about breadth, not just initial uptake. Management pointed to strong demand from new prescribers and broader use across eligible patients, including in the maintenance setting. That matters because repeat ordering is the clearest sign that early trial use is translating into routine practice. Management framed repeat ordering as a driver of continued momentum, supporting quarter-over-quarter growth since launch. ImmunityBio, Inc. price | ImmunityBio, Inc. Quote The commercial build is showing up in operating expenses. Research and development expense rose to $68 million from $48.2 million a year earlier, driven by higher clinical study costs, headcount-related expenses, consulting fees and external manufacturing costs. Selling, general and administrative expense increased to $45.8 million from $32.7 million, reflecting higher professional services and headcount-related costs, plus incremental commercial spending and other items tied to scaling operations. The investment cadence underscores an “earnings later” posture that puts even more weight on sustaining the top-line trajectory. International expansion broadens the long-term opportunity, but the near-term math can be slow. Europe still requires country-by-country reimbursement, with the Big 5 prioritized and Germany expected to commercialize first in 2026. That implies a ramp that may extend into 2027, keeping near-term results disproportionately dependent on the U.S. trajectory. The company has made progress in securing authorizations across multiple jurisdictions, and commercial availability in Saudi Arabia was achieved quickly after announcing Middle East partnerships. Still, stepwise timing and access decisions can vary by country, and reimbursement friction can delay demand conversion even after regulatory wins. ImmunityBio ended March 2026 with nearly $381 million in cash, cash equivalents and marketable securities, alongside approximately $678 million in total debt (long-term only). The balance sheet also includes sizable fair-value liabilities, including a related-party convertible note valued at $678 million and a $404 million revenue interest liability. Management provides no margin or EPS guidance, which increases the importance of execution and adoption timing. Regulatory and compliance items can also be a distraction: the company received FDA promotional correspondence and implemented enhanced review protocols. A workable “hold vs. add” framework starts with what would validate the bullish path. First, investors should look for continued U.S. net product revenues acceleration beyond the 168% year over year and 15% sequential growth rate posted in the first quarter. Second, steady progress converting ex-U.S. authorizations into real demand would help reduce the company’s dependence on a single geography, even if the ramp remains gradual. Third, clean regulatory progress in bladder cancer matters, with the FDA reviewing a filing for Anktiva plus BCG in BCG-unresponsive papillary-only disease and a final decision expected by Jan. 6, 2027, while a BCG-naïve CIS program is positioned for an sBLA submission in 2026. The bear case is easier to define because it ties directly to timing risk. Slower launches or reimbursement delays in Europe could extend U.S. dependence longer than investors expect. Adoption disappointments would be harder to absorb given the elevated sales multiple. And regulatory or legal distractions, including promotional correspondence, could divert attention during a scaling phase. In the near term, a Zacks Rank #3 (Hold) aligns with a wait-for-confirmation posture. Industry peers such as Agenus AGEN and Iovance Biotherapeutics IOVA also carry a Zacks Rank #3, reinforcing that this pocket of biotech remains selective and execution-driven rather than broadly risk-on. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Agenus Inc. (AGEN) : Free Stock Analysis Report Iovance Biotherapeutics, Inc. (IOVA) : Free Stock Analysis Report ImmunityBio, Inc. (IBRX) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-05-12

Agenus (AGEN) Q1 Earnings and Revenues Miss Estimates

Zacks
Agenus (AGEN) came out with quarterly earnings of $1.02 per share, missing the Zacks Consensus Estimate of $2.1 per share. This compares to a loss of $1.03 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -51.43%. A quarter ago, it was expected that this biotechnology company would post a loss of $1.27 per share when it actually produced earnings of $0.56, delivering a surprise of +144.09%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. Agenus, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $33.74 million for the quarter ended March 2026, missing the Zacks Consensus Estimate by 73.95%. This compares to year-ago revenues of $24.07 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Agenus shares have added about 21.7% since the beginning of the year versus the S&P 500's gain of 8.1%. While Agenus has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Agenus was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #1 (Strong Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks…Read full document

Agenus (AGEN) came out with quarterly earnings of $1.02 per share, missing the Zacks Consensus Estimate of $2.1 per share. This compares to a loss of $1.03 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -51.43%. A quarter ago, it was expected that this biotechnology company would post a loss of $1.27 per share when it actually produced earnings of $0.56, delivering a surprise of +144.09%. Over the last four quarters, the company has surpassed consensus EPS estimates just once. Agenus, which belongs to the Zacks Medical - Biomedical and Genetics industry, posted revenues of $33.74 million for the quarter ended March 2026, missing the Zacks Consensus Estimate by 73.95%. This compares to year-ago revenues of $24.07 million. The company has topped consensus revenue estimates two times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Agenus shares have added about 21.7% since the beginning of the year versus the S&P 500's gain of 8.1%. While Agenus has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Agenus was favorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #1 (Strong Buy) for the stock. So, the shares are expected to outperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.32 on $30.35 million in revenues for the coming quarter and $2.10 on $232.9 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Biomedical and Genetics is currently in the bottom 42% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, Kamada (KMDA), is yet to report results for the quarter ended March 2026. The results are expected to be released on May 13. This biopharmaceutical is expected to post quarterly earnings of $0.12 per share in its upcoming report, which represents a year-over-year change of +71.4%. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. Kamada's revenues are expected to be $46.46 million, up 5.6% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Agenus Inc. (AGEN) : Free Stock Analysis Report Kamada Ltd. (KMDA) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-05-12

Agenus: Q1 Earnings Snapshot

Associated Press

LEXINGTON, Mass. (AP) — LEXINGTON, Mass. (AP) — Agenus Inc. (AGEN) on Monday reported first-quarter net income of $39.2 million, after reporting a loss in the same period a year earlier. The Lexington, Massachusetts-based company said it had net income of $1.02 per share. The biotechnology company posted revenue of $33.7 million in the period. In the final minutes of trading on Monday, the company's shares hit $3.26. A year ago, they were trading at $2.91. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on AGEN at https://www.zacks.com/ap/AGEN

Investor releaseQuarter not tagged2026-05-11

Agenus Reports First Quarter 2026 Financial Results and Highlights BOT+BAL Execution Across Global Access and Phase 3 Development

Business Wire
Authorized access interest continues to expand across regions Phase 3 BATTMAN trial commenced patient enrollment in April 2026, advancing BOT+BAL into pivotal evaluation Zydus collaboration closed in January, delivering strategic capital, strengthening Agenus’ balance sheet and securing dedicated U.S. biologics manufacturing capacity Agenus continues to align operating priorities around BOT+BAL, financial discipline and commercial readiness SEC concluded its investigation in May 2026 with no enforcement action recommended; Related putative securities class action dismissed in its entirety by the U.S. District Court for the District of Massachusetts in March 2026 LEXINGTON, Mass., May 11, 2026--(BUSINESS WIRE)--Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today reported financial results for the first quarter ended March 31, 2026, and provided an operational update on botensilimab plus balstilimab (BOT+BAL), the Company’s lead clinical program and one of the most clinically advanced next-generation CTLA-4/PD-1 combinations in development. The first quarter marked a transition from foundation-building to execution for BOT+BAL. Physician engagement through regulatory-authorized access pathways continued to broaden, the Phase 3 BATTMAN trial moved into active enrollment shortly after quarter-end, and the Zydus collaboration closed, delivering strategic capital and dedicated U.S. manufacturing capacity. BOT+BAL is designed to activate both innate and adaptive immunity and extend immunotherapy benefit into tumors that have historically shown limited responsiveness to checkpoint inhibition. "First quarter 2026 was a defining quarter for Agenus and for BOT and BAL," said Garo H. Armen, Ph.D., Chairman and Chief Executive Officer of Agenus. "We saw continued physician requests and engagement treating patients with BOT and BAL through regulatory-authorized access pathways. Additionally, we advanced the program into Phase 3 enrollment and closed a transformative collaboration with Zydus that secured both capital and U.S. manufacturing capacity. BOT+BAL’s maturing data, particularly the durability of survival outcomes in refractory MSS colorectal cancer, continue to underpin our regulatory submissions in the United States and Europe." Key Operational Highlights Agenus is concentrating resources on BOT+BAL across three priorities: supporting physic…Read full document

Authorized access interest continues to expand across regions Phase 3 BATTMAN trial commenced patient enrollment in April 2026, advancing BOT+BAL into pivotal evaluation Zydus collaboration closed in January, delivering strategic capital, strengthening Agenus’ balance sheet and securing dedicated U.S. biologics manufacturing capacity Agenus continues to align operating priorities around BOT+BAL, financial discipline and commercial readiness SEC concluded its investigation in May 2026 with no enforcement action recommended; Related putative securities class action dismissed in its entirety by the U.S. District Court for the District of Massachusetts in March 2026 LEXINGTON, Mass., May 11, 2026--(BUSINESS WIRE)--Agenus Inc. (Nasdaq: AGEN), a leader in immuno-oncology innovation, today reported financial results for the first quarter ended March 31, 2026, and provided an operational update on botensilimab plus balstilimab (BOT+BAL), the Company’s lead clinical program and one of the most clinically advanced next-generation CTLA-4/PD-1 combinations in development. The first quarter marked a transition from foundation-building to execution for BOT+BAL. Physician engagement through regulatory-authorized access pathways continued to broaden, the Phase 3 BATTMAN trial moved into active enrollment shortly after quarter-end, and the Zydus collaboration closed, delivering strategic capital and dedicated U.S. manufacturing capacity. BOT+BAL is designed to activate both innate and adaptive immunity and extend immunotherapy benefit into tumors that have historically shown limited responsiveness to checkpoint inhibition. "First quarter 2026 was a defining quarter for Agenus and for BOT and BAL," said Garo H. Armen, Ph.D., Chairman and Chief Executive Officer of Agenus. "We saw continued physician requests and engagement treating patients with BOT and BAL through regulatory-authorized access pathways. Additionally, we advanced the program into Phase 3 enrollment and closed a transformative collaboration with Zydus that secured both capital and U.S. manufacturing capacity. BOT+BAL’s maturing data, particularly the durability of survival outcomes in refractory MSS colorectal cancer, continue to underpin our regulatory submissions in the United States and Europe." Key Operational Highlights Agenus is concentrating resources on BOT+BAL across three priorities: supporting physician-initiated access through regulatory-authorized pathways where permitted, advancing the Phase 3 BATTMAN trial, and building the clinical, manufacturing and operational readiness needed for the next stage of development. Continued Physician Engagement Through Regulatory-Authorized Access Pathways In parallel with clinical development, Agenus continues to support BOT+BAL access through regulatory-authorized pathways in certain countries. These programs are physician-initiated, patient-specific and governed by local regulations. In France, BOT+BAL is available under the national Autorisation d’Accès Compassionnel framework for eligible patients, with reimbursed access across MSS metastatic colorectal cancer without active liver metastases, platinum-resistant or platinum-refractory ovarian cancer, and certain advanced soft-tissue sarcomas. Outside France, BOT+BAL may be available in select countries through paid named-patient programs, which may involve out-of-pocket payment and/or special insurance arrangements depending on local requirements and individual coverage decisions. In Q1 2026, paid named-patient activity broadened to additional countries in South and Central America and Europe, reflecting continued physician interest and the unmet need for new options while regulatory review pathways advance. In April 2026, Agenus named BAP Pharma as its global partner to support BOT+BAL access programs, including France’s AAC pathway and paid named-patient programs. BAP Pharma will support program requests, case coordination, regulatory navigation, distribution logistics and related payment processing, helping Agenus build a more consistent and scalable access infrastructure. Medical Affairs Infrastructure Expanded to Support Increasing Physician Requests Agenus also expanded Medical Affairs and early-access support capabilities to respond to increasing physician-initiated interest. These capabilities support scientific exchange, access request coordination, pharmacovigilance and structured collection of real-world safety and outcomes data where applicable. Phase 3 BATTMAN Trial Active and Enrolling The global Phase 3 BATTMAN trial commenced patient enrollment in April 2026 and is evaluating BOT+BAL versus best supportive care in patients with refractory, unresectable MSS/pMMR metastatic colorectal cancer, a setting where checkpoint inhibitors have historically shown limited benefit and treatment options remain limited. BATTMAN is led by the Canadian Cancer Trials Group as an international cooperative-group trial, with participating academic networks in Canada, France, Australia and New Zealand. Site activation continues across participating regions. With BATTMAN underway, BOT+BAL is among the most clinically advanced next-generation CTLA-4/PD-1 immunotherapy programs in refractory colorectal cancer, supported by a global randomized Phase 3 study. Zydus Collaboration Closed Strengthening Capital Position, Balance Sheet and Manufacturing Readiness In January 2026, Agenus closed its previously announced strategic collaboration with Zydus Lifesciences, providing upfront capital and dedicated biologics manufacturing capacity to support clinical development, authorized access programs and potential future commercial supply of BOT+BAL. At closing, Zydus paid $91 million of upfront capital, subject to customary adjustments and escrow arrangements, and the $7.0 million Zydus Promissory Note was forgiven. The collaboration delivered: $75 million in cash consideration for the transfer of the Emeryville and Berkeley biologics manufacturing facilities $16 million equity investment in Agenus common stock Up to $50 million in contingent payments from Zydus tied to BOT and BAL production orders by Agenus An exclusive license for Zydus to develop and commercialize BOT and BAL in India and Sri Lanka, with Agenus eligible to receive royalties on net sales in those territories The collaboration strengthens Agenus’ balance sheet while securing dedicated U.S. manufacturing infrastructure for the next stage of BOT+BAL clinical, regulatory and commercial expansion. It also supports Agenus’ ability to supplement existing supply for clinical development, authorized access pathways and potential future commercial readiness without requiring additional Agenus capital expenditures for dedicated manufacturing infrastructure. Clinical Data Continue to Support Immune Activation and Durability Across Hard-to-Treat Tumors Recent clinical and translational data presentations continue to add to the broader BOT+BAL evidence base, including evaluations of BOT+BAL in combination approaches across additional difficult-to-treat tumor types and in earlier stages of MSS mCRC treatment. These datasets support the Company’s view that BOT+BAL may contribute to durable, immune-mediated activity across tumors that have historically responded poorly to checkpoint inhibition. Across Phase 1 and Phase 2 clinical trials, approximately 1,300 patients have been treated with botensilimab and/or balstilimab, with clinical activity observed across more than nine metastatic, late-line cancers settings. Agenus continues to view durability, survival and immune activation, rather than response rates alone, as meaningful measures of BOT+BAL’s clinical potential in cold or treatment-refractory tumors historically resistant to checkpoint inhibition. First Quarter 2026 Financial Results Cash and cash equivalents totaled $35.0 million as of March 31, 2026, compared with $3.0 million as of December 31, 2025. Subsequent to quarter-end, the Company received an additional $11.7 million in net proceeds from sales of common stock under its at-the-market equity offering program. The Company also expects to collect outstanding receivables under regulatory-authorized early access programs during the second quarter of 2026. Pre-commercial product revenue of $4.6 million represents realized income from BOT+BAL provided to hospitals and treating physicians under regulatory-authorized early access pathways, including France's AAC framework and paid named-patient programs in countries where permitted. During the first quarter of 2026, Agenus made cash payments of approximately $51.8 million, principally to fund (i) the release of commercial-grade botensilimab supply through contract development and manufacturing organizations; (ii) the generation of clinical data sets through contract research organizations and clinical support providers in support of the Company's planned accelerated approval submission in the United States and conditional marketing authorization application in the European Union; and (iii) settlement of obligations in connection with the closing of the Zydus collaboration, including finance lease and debt obligations, and other closing-related payments. These payments partly settled liabilities accrued in prior periods. Agenus’ first quarter cash payments included substantial obligations associated with the Zydus closing and the build-out of clinical and pre-commercial supply. These are not representative of Agenus’ recurring operating expense profile. The Company continues to align its operating expense base with its previously communicated framework of approximately $50 million in annualized operating expenses to support BOT+BAL development priorities, and first quarter 2026 underlying operating performance was consistent with that framework. In March 2026, Agenus triggered the first $20.0 million contingent payment from Zydus under the collaboration based on Zydus services provided which includes contracted work orders for BOT+BAL production activities. All contingent payments by Zydus are to fund services to be provided by Zydus to the Company. 2026 Strategic Priorities Support responsible authorized access through France’s AAC framework and paid named-patient programs in select countries, with BAP Pharma serving as global access partner Continue regulatory engagement, including planned accelerated approval and conditional marketing authorization pathways, supported by clinical data and real-world experience generated through authorized access pathways where applicable Advance global BATTMAN trial enrollment in partnership with CCTG and participating academic networks Maintain disciplined capital allocation and continue strengthening the balance sheet Continue clinical and translational data generation across BOT+BAL programs Resolution of SEC Investigation and Dismissal of Securities Class Action On May 4, 2026, the U.S. Securities and Exchange Commission informed Agenus that it has concluded its investigation as to the Company and does not intend to recommend an enforcement action. Separately, on March 24, 2026, the U.S. District Court for the District of Massachusetts granted Agenus's motion to dismiss the related putative securities class action in its entirety. The lead plaintiff has filed a Notice of Appeal to the U.S. Court of Appeals for the First Circuit. Additional information regarding both matters is included in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2026. Webcast and Annual Shareholder Meeting Information Agenus will host a webcast in connection with its Annual Shareholder Meeting in June 2026 to provide strategic updates, highlight key data milestones and discuss progress across the global BOT+BAL development program. Additional details, including webcast access information, will be announced prior to the event. About Agenus Agenus is a clinical-stage immuno-oncology company advancing a pipeline of antibody-based programs designed to activate innate and adaptive immunity, overcome tumor immune evasion, and expand the population of patients who may benefit from immunotherapy. Founded in 1994, Agenus’ lead program is botensilimab plus balstilimab (BOT+BAL), a next-generation Fc-enhanced CTLA-4 plus PD-1 combination that has been evaluated in approximately 1,300 patients across more than nine tumor types. The global Phase 3 BATTMAN trial, conducted with the Canadian Cancer Trials Group, is evaluating BOT+BAL in refractory MSS/pMMR metastatic colorectal cancer. BOT/BAL is also available to eligible patients through regulatory-authorized access pathways in select countries, including France's national Autorisation d'Accès Compassionnel framework. Agenus secured dedicated long-term U.S. biologics manufacturing capacity through its strategic collaboration with Zydus Lifesciences, closed in January 2026. Agenus also holds an equity investment in MiNK Therapeutics, Inc. (Nasdaq: INKT), a clinical-stage developer of allogeneic invariant natural killer T cell therapies, and a majority interest in SaponiQx, Inc., a vaccine adjuvant business. Agenus is headquartered in Lexington, Massachusetts. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on the Company's website and social media channels. About BATTMAN CO.33 Phase 3 Trial The BATTMAN (CCTG CO.33) trial is a global Phase 3, randomized, controlled study evaluating botensilimab (BOT) plus balstilimab (BAL) versus best supportive care in patients with refractory, unresectable microsatellite stable (MSS)/mismatch repair proficient (pMMR) colorectal cancer. Conducted as an international cooperative-group study led by the Canadian Cancer Trials Group (CCTG), the trial is expected to enroll approximately 830 patients across more than 100 sites in Canada, France, Australia, and New Zealand. Participating academic networks include CCTG, GI Cancer Trials, and France’s Partenariat de Recherche en Oncologie Digestive (PRODIGE), sponsored by Unicancer. This registrational-enabling study is designed to support potential regulatory submissions for BOT+BAL in this difficult-to-treat patient population. Agenus’ Commitment to Patient Access Until marketing authorization is granted, BOT+BAL is accessible only through clinical trials including the Phase 3 BATTMAN trial in refractory MSS colorectal cancer and authorized early access mechanisms where permitted and available under each country’s regulatory framework. For eligible French patients treated in hospital under AAC meeting the pre-defined criteria, BOT+BAL is fully reimbursed by France’s national health system. Outside France, access may be available in select countries through paid named-patient programs, which may involve out-of-pocket payment and/or special insurance arrangements depending on local regulations and individual coverage decisions. About Botensilimab (BOT) Botensilimab (BOT) is a human Fc-enhanced multifunctional anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to "cold" tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Approximately 1,300 patients have been treated with botensilimab and/or balstilimab in Phase 1 and Phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov. About Balstilimab (BAL) Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding Agenus’ botensilimab and balstilimab programs, access programs, clinical development plans, manufacturing readiness, operating expense reductions, financial outlook, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," "potential," and similar expressions intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of Agenus’ most recent Annual Report on Form 10-K for 2025 and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. View source version on businesswire.com: https://www.businesswire.com/news/home/20260511199340/en/ Contacts Investors: 917-362-1370 | [email protected] Media: 781-674-4422 | [email protected]

Investor releaseQuarter not tagged2026-05-11

RCKT Stock Down on Q1 Earnings Miss, Kresladi Launch in Focus

Zacks
Shares of Rocket Pharmaceuticals RCKT were down on Friday after the company announced weaker-than-expected first-quarter 2026 earnings. RCKT incurred a loss of 42 cents per share in the first quarter of 2026, wider than the Zacks Consensus Estimate of a loss of 41 cents. In the year-ago quarter, the company had reported a loss of 56 cents per share. Rocket Pharmaceuticals did not record any revenues in the first quarter. Year to date, shares of Rocket Pharmaceuticals have risen 3.4% against the industry’s decline of 1.7%. Image Source: Zacks Investment Research In the reported quarter, general and administrative expenses declined by around 39.8% year over year to $17.1 million, owing to lower legal expenses and other expenses. Research and development expenses were $31.5 million, down 12.2% from the year-ago quarter’s figure. The decrease reflects more disciplined spending and resource management after the company’s recent organizational restructuring. As of March 31, 2026, Rocket Pharmaceuticals had cash, cash equivalents and investments of $144.4 million compared with $188.9 million as of Dec. 31, 2025. Management expects this cash balance, along with proceeds from the sale of the Priority Review Voucher (PRV) announced last month, to fund operations into the second quarter of 2028. In March 2026, the FDA granted accelerated approval to RCKT’s gene therapy Kresladi (marnetegragene autotemcel) to treat patients with severe leukocyte adhesion deficiency-I (LAD-I), an ultra-rare genetic disorder. Following the nod, Kresladi became the first gene therapy to be approved by the FDA for treating children with severe LAD-I due to biallelic variants in ITGB2 without an available human leukocyte antigen-matched sibling donor for allogeneic hematopoietic stem cell transplant. With the FDA approval for Kresladi, the company received a Rare Pediatric Disease PRV, which is an incentive given by the FDA to encourage the development of drugs and biologics for rare and serious diseases. Last month, RCKT entered into a definitive agreement to sell its PRV for $180 million. The PRV monetization provides non-dilutive capital to support the company’s cardiovascular pipeline. Last August, the FDA lifted the clinical hold on the pivotal phase II study evaluating RCKT’s investigational gene therapy candidate, RP-A501, for treating patients with Danon disease. RP-A501 is the most…Read full document

Shares of Rocket Pharmaceuticals RCKT were down on Friday after the company announced weaker-than-expected first-quarter 2026 earnings. RCKT incurred a loss of 42 cents per share in the first quarter of 2026, wider than the Zacks Consensus Estimate of a loss of 41 cents. In the year-ago quarter, the company had reported a loss of 56 cents per share. Rocket Pharmaceuticals did not record any revenues in the first quarter. Year to date, shares of Rocket Pharmaceuticals have risen 3.4% against the industry’s decline of 1.7%. Image Source: Zacks Investment Research In the reported quarter, general and administrative expenses declined by around 39.8% year over year to $17.1 million, owing to lower legal expenses and other expenses. Research and development expenses were $31.5 million, down 12.2% from the year-ago quarter’s figure. The decrease reflects more disciplined spending and resource management after the company’s recent organizational restructuring. As of March 31, 2026, Rocket Pharmaceuticals had cash, cash equivalents and investments of $144.4 million compared with $188.9 million as of Dec. 31, 2025. Management expects this cash balance, along with proceeds from the sale of the Priority Review Voucher (PRV) announced last month, to fund operations into the second quarter of 2028. In March 2026, the FDA granted accelerated approval to RCKT’s gene therapy Kresladi (marnetegragene autotemcel) to treat patients with severe leukocyte adhesion deficiency-I (LAD-I), an ultra-rare genetic disorder. Following the nod, Kresladi became the first gene therapy to be approved by the FDA for treating children with severe LAD-I due to biallelic variants in ITGB2 without an available human leukocyte antigen-matched sibling donor for allogeneic hematopoietic stem cell transplant. With the FDA approval for Kresladi, the company received a Rare Pediatric Disease PRV, which is an incentive given by the FDA to encourage the development of drugs and biologics for rare and serious diseases. Last month, RCKT entered into a definitive agreement to sell its PRV for $180 million. The PRV monetization provides non-dilutive capital to support the company’s cardiovascular pipeline. Last August, the FDA lifted the clinical hold on the pivotal phase II study evaluating RCKT’s investigational gene therapy candidate, RP-A501, for treating patients with Danon disease. RP-A501 is the most advanced AAV-based candidate in the company’s pipeline. Per an agreement with the FDA, three more patients are being treated with a lower, recalibrated dose of RP-A501 (3.8 x 10¹³ GC/kg), with a minimum four-week interval between doses and an updated immune-modulating regimen. After these patients are treated, RCKT will discuss completion of the pivotal phase II study with the FDA. The company expects to provide an update in the second half of 2026 following these discussions. Rocket Pharmaceuticals is also developing RP-A601 in an early-stage study for treating arrhythmogenic cardiomyopathy. The company also plans to start clinical studies on a new gene therapy candidate, RP-A701, for the treatment of dilated cardiomyopathy by mid-2026. Rocket Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Rocket Pharmaceuticals, Inc. Quote Rocket Pharmaceuticals currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the biotech sector are Agenus AGEN, Amarin AMRN and AnaptysBio ANAB, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Agenus’ 2026 earnings per share have risen from 58 cents to $2.10, while loss per share estimates for 2027 have narrowed from $1.51 to 73 cents during the same time. AGEN shares have surged 21.6% year to date. Agenus’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 31.42%. Over the past 60 days, 2026 loss per share estimates for Amarin have narrowed from $7.01 to $6.36, while the same for 2027 have narrowed from $5.50 to $4.64 during the same time. AMRN stock has risen 7.8% year to date. Amarin's earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 50.02%. Over the past 60 days, 2026 loss per share estimates for AnaptysBio have narrowed from $3.61 to $1.30, while estimates for 2027 have moved from a loss of $4.59 per share to earnings of $3.01 during the same time. ANAB stock has surged 43% year to date. AnaptysBio’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 59.70%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Agenus Inc. (AGEN) : Free Stock Analysis Report Amarin Corporation PLC (AMRN) : Free Stock Analysis Report AnaptysBio, Inc. (ANAB) : Free Stock Analysis Report Rocket Pharmaceuticals, Inc. (RCKT) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-05-09

VRTX's Alyftrek, Journavx & Casgevy See Strong Momentum in Q1 Earnings

Zacks
Vertex Pharmaceuticals Incorporated’s VRTX first-quarter 2026 results were decent as it beat estimates for earnings and sales. The company’s total revenues of $2.99 billion rose 8% year over year, driven by higher sales of cystic fibrosis (CF) drugs Trikafta/Kaftrio and Alyftrek, as well as meaningful contributions from new non-CF products, Journavx and Casgevy. Vertex reiterated its full-year 2026 revenue guidance in the range of $12.95-$13.10 billion for 2026. Investor focus was on the performance of Vertex’s newer drugs, Alyftrek, Journavx and Casgevy, which were launched in the past couple of years and hold the key to long-term growth. Alyftrek is a once-a-day oral triple combination regimen for CF. Journavx is a novel non-opioid pain medicine (suzetrigine) and Vertex and partner CRISPR Therapeutics’ CRSP Casgevy is a one-shot gene therapy approved for two blood disorders, sickle cell disease and transfusion-dependent beta-thalassemia. Year to date, shares of Vertex have declined 6.3% compared with the industry’s decrease of 0.2%. Image Source: Zacks Investment Research Let’s dig deeper to understand how these new products performed in the first quarter and the company’s outlook for the same through the rest of the year. Alyftrek continues to outperform expectations and generated sales worth $424.4 million in the first quarter compared with $380.1 million in the fourth quarter. The rollout of Alyftrek in the United States and Europe is progressing well across all patient groups. The drug has now surpassed $1 billion in cumulative global revenues since its approval in the United States in late 2024 and in the EU in July 2025. Alyftrek’s once-daily dosing and improved sweat chloride profile continue to resonate with patients and doctors. In the first quarter, products from Vertex’s new non-CF disease areas, namely Casgevy and Journavx, drove approximately 25% of total product revenue growth, which was encouraging as Vertex’s dependence on just the CF franchise for revenues has been a growing concern. CF sales are also slightly slowing down. Journavx (suzetrigine) generated $29 million in sales in the first quarter compared with $26.7 million in the fourth quarter. Prescription growth remains strong, although first-quarter revenues reflected some normal inventory destocking. More than 350,000 prescriptions were written for Journavx across both hospital and…Read full document

Vertex Pharmaceuticals Incorporated’s VRTX first-quarter 2026 results were decent as it beat estimates for earnings and sales. The company’s total revenues of $2.99 billion rose 8% year over year, driven by higher sales of cystic fibrosis (CF) drugs Trikafta/Kaftrio and Alyftrek, as well as meaningful contributions from new non-CF products, Journavx and Casgevy. Vertex reiterated its full-year 2026 revenue guidance in the range of $12.95-$13.10 billion for 2026. Investor focus was on the performance of Vertex’s newer drugs, Alyftrek, Journavx and Casgevy, which were launched in the past couple of years and hold the key to long-term growth. Alyftrek is a once-a-day oral triple combination regimen for CF. Journavx is a novel non-opioid pain medicine (suzetrigine) and Vertex and partner CRISPR Therapeutics’ CRSP Casgevy is a one-shot gene therapy approved for two blood disorders, sickle cell disease and transfusion-dependent beta-thalassemia. Year to date, shares of Vertex have declined 6.3% compared with the industry’s decrease of 0.2%. Image Source: Zacks Investment Research Let’s dig deeper to understand how these new products performed in the first quarter and the company’s outlook for the same through the rest of the year. Alyftrek continues to outperform expectations and generated sales worth $424.4 million in the first quarter compared with $380.1 million in the fourth quarter. The rollout of Alyftrek in the United States and Europe is progressing well across all patient groups. The drug has now surpassed $1 billion in cumulative global revenues since its approval in the United States in late 2024 and in the EU in July 2025. Alyftrek’s once-daily dosing and improved sweat chloride profile continue to resonate with patients and doctors. In the first quarter, products from Vertex’s new non-CF disease areas, namely Casgevy and Journavx, drove approximately 25% of total product revenue growth, which was encouraging as Vertex’s dependence on just the CF franchise for revenues has been a growing concern. CF sales are also slightly slowing down. Journavx (suzetrigine) generated $29 million in sales in the first quarter compared with $26.7 million in the fourth quarter. Prescription growth remains strong, although first-quarter revenues reflected some normal inventory destocking. More than 350,000 prescriptions were written for Journavx across both hospital and retail settings in the quarter compared to approximately 550,000 in all of 2025, showing that uptake is accelerating. In 2026, Vertex expects Journavx prescriptions to triple compared to 550,000 written in 2025, supported by a larger commercial field force, wider payer coverage, and improving gross-to-net economics. Journavx’s reimbursement trends are also improving. Coverage has expanded to about 240 million lives, supported by agreements with the three largest commercial pharmacy benefit managers. The company also secured its first major Medicare Part D coverage agreement, effective May 1. Discussions are continuing with the remaining major Medicare plans and regional payers, which could further expand access. Vertex and partner CRISPR’s one-shot gene therapy, Casgevy’s sales were $42.9 million in the first quarter of 2026, down from $54.3 million recorded in the fourth quarter of 2025 due to quarter-to-quarter variability in Casgevy infusions. Nonetheless, the launch of Casgevy is gaining traction across the United States, Europe and the Middle East, with more than 500 patients having started treatment since launch, hundreds completing initial cell collection, and many already reaching the stage where edited cells are ready for infusion. Vertex is also making rapid progress in the drug’s access and reimbursement and secured a pricing agreement for Casgevy in Germany in the first quarter. In 2026, Vertex expects continued quarter-to-quarter variability in Casgevy infusions, which the company expects will smooth out in 2027 and beyond. While Alyftrek will be the key driver of Vertex’s total revenues in 2026, with Journavx and Casgevy gaining traction, Vertex is steadily broadening its growth base beyond CF. The company expects non-CF products to generate revenues of $500 million plus in 2026, representing year-over-year growth of around 185%, driven by growing Casgevy infusions and a meaningful ramp in Journavx prescriptions and revenues. Vertex currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Agenus AGEN and Amarin AMRN, each carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here. Agenus’ shares have risen 29.2% in the past year. Estimates for its 2026 earnings per share have increased from 54 cents to $1.30 over the past 60 days. Loss estimates for 2027 have narrowed from $1.91 per share to $1.52 per share. Agenus’ earnings beat estimates in two of the trailing four quarters while missing in the other two, with the average surprise being 31.42%. In the past 60 days, estimates for Amarin’s loss per share have narrowed from $7.01 to $6.36 for 2026. During the same time, loss per share estimates for 2027 have narrowed from $5.50 to $4.64. In the past year, shares of AMRN have gained 42%. Amarin’s earnings beat estimates in three of the trailing four quarters while missing in one, the average surprise being 50.02%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Vertex Pharmaceuticals Incorporated (VRTX) : Free Stock Analysis Report Agenus Inc. (AGEN) : Free Stock Analysis Report Amarin Corporation PLC (AMRN) : Free Stock Analysis Report CRISPR Therapeutics AG (CRSP) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Investor releaseQuarter not tagged2026-05-08

TGTX Q1 Earnings Miss, Sales Rise Y/Y, Stock Up on Raised 2026 View

Zacks
TG Therapeutics TGTX reported earnings of 17 cents per share (excluding the loss on extinguishment of debt) for the first quarter of 2026, missing the Zacks Consensus Estimate of 23 cents. The company had reported earnings of 3 cents per share in the year-ago quarter. Total revenues in the first quarter were $204.9 million, up almost 69.5% year over year, driven by strong demand for the company’s sole marketed drug, Briumvi (ublituximab-xiiy). The figure beat the Zacks Consensus Estimate of $199 million. Briumvi, an anti-CD20 monoclonal antibody, was approved by the FDA for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) in December 2022. The drug is also approved in the European Union, the United Kingdom, Australia, Switzerland and certain other countries. The top line comprised product sales from Briumvi and license, royalty and other revenues. Total product revenues were $201.3 million in the first quarter, reflecting a 68.2% year-over-year increase. Total product revenues included sales of Briumvi to TGTX’s licensing partner, in ex-U.S. markets, Neuraxpharm, of $6.5 million. TG Therapeutics has an agreement with Neuraxpharm Pharmaceuticals for the ex-U.S. commercialization of Briumvi, wherein the company is entitled to receive payments upon the achievement of certain commercial milestones and targets. Briumvi's net product sales in the United States were $194.8 million in the first quarter, up 63% year over year. Sales of the drug came in ahead of management’s guided range of $185-$190 million. License, milestone, royalty and other revenues were $3.6 million in the first quarter, compared with $1.2 million reported in the year-ago quarter. Research and development (R&D) expenses (excluding non-cash compensation) rose around 1.2% year over year to $43.5 million due to higher expenses related to ongoing clinical studies. Selling, general and administrative (SG&A) expenses (excluding non-cash compensation) totaled $73.1 million, up almost 88.9% from the year-ago quarter’s level, due to higher commercialization costs for Briumvi as well as other personnel costs. As of March 31, 2026, TG Therapeutics had cash, cash equivalents and investments worth $572.8 million compared with $199.5 million as of Dec. 31, 2025. TG Therapeutics raised its total revenue guidance. The company now expects worldwide total revenues of around $925 m…Read full document

TG Therapeutics TGTX reported earnings of 17 cents per share (excluding the loss on extinguishment of debt) for the first quarter of 2026, missing the Zacks Consensus Estimate of 23 cents. The company had reported earnings of 3 cents per share in the year-ago quarter. Total revenues in the first quarter were $204.9 million, up almost 69.5% year over year, driven by strong demand for the company’s sole marketed drug, Briumvi (ublituximab-xiiy). The figure beat the Zacks Consensus Estimate of $199 million. Briumvi, an anti-CD20 monoclonal antibody, was approved by the FDA for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) in December 2022. The drug is also approved in the European Union, the United Kingdom, Australia, Switzerland and certain other countries. The top line comprised product sales from Briumvi and license, royalty and other revenues. Total product revenues were $201.3 million in the first quarter, reflecting a 68.2% year-over-year increase. Total product revenues included sales of Briumvi to TGTX’s licensing partner, in ex-U.S. markets, Neuraxpharm, of $6.5 million. TG Therapeutics has an agreement with Neuraxpharm Pharmaceuticals for the ex-U.S. commercialization of Briumvi, wherein the company is entitled to receive payments upon the achievement of certain commercial milestones and targets. Briumvi's net product sales in the United States were $194.8 million in the first quarter, up 63% year over year. Sales of the drug came in ahead of management’s guided range of $185-$190 million. License, milestone, royalty and other revenues were $3.6 million in the first quarter, compared with $1.2 million reported in the year-ago quarter. Research and development (R&D) expenses (excluding non-cash compensation) rose around 1.2% year over year to $43.5 million due to higher expenses related to ongoing clinical studies. Selling, general and administrative (SG&A) expenses (excluding non-cash compensation) totaled $73.1 million, up almost 88.9% from the year-ago quarter’s level, due to higher commercialization costs for Briumvi as well as other personnel costs. As of March 31, 2026, TG Therapeutics had cash, cash equivalents and investments worth $572.8 million compared with $199.5 million as of Dec. 31, 2025. TG Therapeutics raised its total revenue guidance. The company now expects worldwide total revenues of around $925 million in 2026, including net product revenues of $885-$900 million from Briumvi sales in the United States. Previously, the company expected total revenues in the range of $875 million to $900 million in 2026, including net product revenues of $825-$850 million from Briumvi sales in the United States. Owing to the upbeat revenue outlook, TGTX shares were up 16.3% yesterday following the announcement of the news. The stock has rallied 40.8% in the year-to-date period against the industry’s decline of 1.6%. Image Source: Zacks Investment Research In the second quarter of 2026, net product revenues from Briumvi sales in the United States are expected to be $220 million. Excluding non-cash compensation, total operating expenses, defined as R&D and SG&A, are expected to be around $350 million in 2026, unchanged from the previous expectation. Several additional studies on Briumvi targeting other autoimmune diseases are currently ongoing. Last month, TG Therapeutics completed enrollment in the phase III study evaluating the subcutaneous formulation of Briumvi for treating people with relapsing forms of multiple sclerosis (RMS). Top-line data from the same is to be announced by the end of 2026 or the first quarter of 2027. The company recently completed patient enrollment in the phase III ENHANCE study evaluating the potential to consolidate the day-one and day-15 infusions of Briumvi into a single 600-mg infusion on day one. Top-line data from the study is expected in mid-2026. TG Therapeutics is also developing Briumvi for additional autoimmune indications, including starting a potentially registration-directed study evaluating Briumvi in patients with myasthenia gravis. TG Therapeutics is also developing azer-cel, an allogeneic CD19-directed CAR T cell therapy, in a phase I study for treating patients with primary progressive multiple sclerosis. Preliminary data from this study is expected to be presented in the second half of 2026. TG Therapeutics, Inc. price-consensus-eps-surprise-chart | TG Therapeutics, Inc. Quote TG Therapeutics currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the biotech sector are Agenus AGEN, AnaptysBio ANAB and Amarin AMRN, each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Agenus’ 2026 earnings per share have risen from 54 cents to $1.30, while loss per share estimates for 2027 have narrowed from $1.91 to $1.52 during the same time. AGEN shares have surged 23.9% year to date. Agenus’ earnings beat estimates in two of the trailing four quarters, while missing the same on the remaining two occasions, with the average surprise being 31.42%. Over the past 60 days, 2026 loss per share estimates for AnaptysBio have narrowed from $1.42 to $1.40, while estimates for 2027 have moved from a loss of $4.59 per share to earnings of $3.01 during the same time. ANAB stock has increased 38.9% year to date. AnaptysBio’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 59.70%. Over the past 60 days, 2026 loss per share estimates for Amarin have narrowed from $7.01 to $6.36, while the same for 2027 have narrowed from $5.50 to $4.64 during the same time. AMRN stock has risen 6.8% year to date. Amarin's earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 50.02%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Agenus Inc. (AGEN) : Free Stock Analysis Report Amarin Corporation PLC (AMRN) : Free Stock Analysis Report TG Therapeutics, Inc. (TGTX) : Free Stock Analysis Report AnaptysBio, Inc. (ANAB) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

As of 2026-08-08 • Updated weeklySource: Earnings sourceIngestion runbook