IMCR

Immunocore Holdings plc IMCR incurred a loss of 2 cents per share in the second quarter of 2026, wider than the Zacks Consensus Estimate of a loss of 1 cent per share. In the year-ago quarter, the company had incurred a loss of 20 cents per share. Second-quarter revenues were $115.9 million, increasing 18.3% year over year, mainly on higher volumes of its sole marketed drug, Kimmtrak (tebentafusp-tebn), in the United States and international regions. The top line beat the Zacks Consensus Estimate of $114 million. Immunocore's top line solely comprised worldwide net product sales of Kimmtrak. Year to date, shares of Immunocore have lost 0.6% against the industry’s rise of 4.4%. Image Source: Zacks Investment Research Kimmtrak generated $74.9 million in U.S. sales, $34.1 million in Europe and $6.9 million across international regions during the second quarter. U.S. quarterly sales rose 17% year over year, while combined Europe and international sales increased 21% on higher demand. Management noted that U.S. second-quarter sales included roughly $6 million of distributor inventory stocking, which is expected to create a headwind in the third quarter. Excluding this stocking effect, underlying sequential quarterly growth was 3%. Kimmtrak has been launched in more than 30 countries globally. The drug continues to be the standard of care in all major markets where it is launched. Research and development expenses increased around 7.2% year over year to $73.9 million in the second quarter. The increase primarily reflected advancement of clinical programs, including three phase III studies. Selling, general and administrative expenses rose 2.6% year over year to $43.9 million. As of June 30, 2026, Immunocore had cash, cash equivalents and marketable securities worth $880.2 million compared with $844.9 million as of March 31, 2026. The registrational phase III TEBE-AM study is evaluating Kimmtrak as monotherapy and in combination with Keytruda (pembrolizumab) versus a control arm in previously treated advanced cutaneous melanoma. The primary endpoint of the study is overall survival. Enrollment in the phase III TEBE-AM study is nearing the target of 540 patients. Top-line data from the same can be announced as early as the end of 2026. Meanwhile, the EORTC-sponsored phase III ATOM study in high-risk adjuvant uveal melanoma continues to expand its site footprint and is now enrolling patients in the United States. Beyond Kimmtrak, Immunocore is advancing a diversified pipeline of ImmTAC candidates across multiple oncology indications. Brenetafusp is the company’s lead PRAME-A02 ImmTAC bispecific candidate.  The registrational phase III PRISM-MEL-301 study is evaluating brenetafusp in combination with Opdivo (nivolumab) for treating first-line advanced cutaneous melanoma. The candidate is also being investigated in early-to-mid-stage studies both as monotherapy and as combination therapy in multiple tumor types, including ovarian cancer and non-small cell lung cancer. Immunocore is also progressing in earlier-stage programs targeting colorectal cancer and other gastrointestinal cancers as well as certain infectious diseases and autoimmune diseases using its proprietary T-cell receptor platform. Immunocore Holdings PLC Sponsored ADR price-consensus-eps-surprise-chart | Immunocore Holdings PLC Sponsored ADR Quote Immunocore currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the biotech sector are Harmony Biosciences HRMY, Repligen RGEN and Liquidia Corporation LQDA, 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 Harmony Biosciences’ 2026 earnings per share have risen from $3.20 to $3.62, while estimates for 2027 have increased from $3.64 to $4.07 during the same time. HRMY shares have gained 3.5% year to date. Harmony Biosciences’ earnings missed estimates in three of the trailing four quarters and beat on the remaining occasion, delivering an average negative surprise of 13.97%. Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.62 during the same time. RGEN shares have declined 2.7% year to date. Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%. Over the past 60 days, estimates for Liquidia’s 2026 earnings per share have risen from $2.97 to $3.02, while estimates for 2027 have increased from $4.81 to $5.31 during the same time. LQDA shares have surged 159.3% year to date. Liquidia’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 54.40%. 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 Immunocore Holdings PLC Sponsored ADR (IMCR) : Free Stock Analysis Report Repligen Corporation (RGEN) : Free Stock Analysis Report Liquidia Corporation (LQDA) : Free Stock Analysis Report Harmony Biosciences Holdings, Inc. (HRMY) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Immunocore reports second quarter financial results and provides a business update KIMMTRAK® (tebentafusp-tebn) net revenues of $115.9 million in Q2 2026, growing by 18% year-over-year Enrollment in Phase 3 TEBE-AM trial for previously treated advanced cutaneous melanoma nearing the target of 540 patients – Data could come as early as end of 2026 Oral presentation of five-year overall survival data showing KIMMTRAK doubles likelihood of being alive at five years for patients with HLA-A*02:01 positive metastatic uveal melanoma Promising Phase 1 brenetafusp monotherapy clinical activity in heavily pretreated HLA-A*02:01-positive patients with advanced melanoma, presented at ASCO, supports selected dose for Phase 3 PRISM-MEL-301 trial in first-line advanced melanoma Cash, cash equivalents and marketable securities of $880 million as of June 30, 2026 Conference call today, August 6 at 8:00 AM ET, 1:00 PM BST (OXFORDSHIRE, England & RADNOR, PA. & GAITHERSBURG, MD., US, 6 August 2026) Immunocore Holdings plc (Nasdaq: IMCR) (“Immunocore” or the “Company”), a commercial-stage biotechnology company pioneering and delivering transformative immunomodulating medicines to radically improve outcomes for patients with cancer, infectious diseases and autoimmune diseases, today announced its financial results for the first half ended June 30, 2026, and provided a business update. "The five-year overall survival data for KIMMTRAK underscores the lasting impact of our medicine for patients with metastatic uveal melanoma and reinforces our confidence in the potential of our platform," said Bahija Jallal, CEO of Immunocore. "With enrollment in our Phase 3 TEBE-AM trial nearing target completion and continued progress across our pipeline, we remain focused on our mission: delivering innovative transformative medicines to improve outcomes for patients with serious diseases." Second Quarter and First Half Highlights (including post-period) Financial Results For the second quarter ended June 30, 2026, total net product revenue (or ‘net sales’) arising from the sales of KIMMTRAK was $115.9 million, compared to $98.0 million for the same period in 2025. Q2 2026 sales were $74.9 million in the United States, $34.1 million in Europe, and $6.9 million in international regions. The increase in net product sales was primarily due to increased volumes in the United States and international regions. Research and development (R&D) expenses for Q2 2026 were $73.9 million, compared to $69.0 million for Q2 2025. This increase was primarily due to advancement of our clinical programs, including our three Phase 3 studies. Selling, general and administrative (SG&A) expenses for Q2 2026 were $43.9 million, compared to $42.8 million for Q2 2025. Net loss for Q2 2026 was $0.8 million ($0.02 loss per share) compared to $10.3 million ($0.20 loss per share) for Q2 2025. Net income for the six months ended June 30, 2026, was $12.2 million ($0.23 income per share) compared to a net loss for the six months ended June 30, 2025, of $5.3 million ($0.11 loss per share). Cash, cash equivalents and marketable securities were $880.2 million as of June 30, 2026, as compared to $864.2 million as of December 31, 2025. The Company expects to pay, in the second half of 2026, approximately $120 million in sales-related rebate accruals. KIMMTRAKThe Company’s lead product, KIMMTRAK® (tebentafusp), is approved in 39 countries and has been launched in over 30 countries globally to date for HLA-A*02:01 positive people with unresectable or metastatic uveal melanoma (mUM). KIMMTRAK continues to be the standard of care in all major markets where it is launched. The Company sees three key growth areas in the fifth year since the launch of KIMMTRAK as it plans to expand patient reach, including continued US community and global market penetration in mUM, the potential expansion into 2L+ advanced cutaneous melanoma (CM), and the potential expansion into adjuvant uveal melanoma. Metastatic uveal melanoma KIMMTRAK net product sales were $115.9 million and $222.6 million for the three and six months ended June 30, 2026, representing increases of 18% and 16% respectively, as compared to the same periods in 2025. 17% year-over-year quarterly sales growth in the United States with mean duration of treatment of 14 months. 21% year-over-year quarterly sales growth combined in Europe and International, driven by increased demand. Five-year overall survival (OS) data, from the Phase 3 trial of KIMMTRAK in patients with unresectable or mUM, were presented at the AACR 2026 meeting, representing the longest follow-up reported for any T cell engager in a solid tumor. KIMMTRAK doubled the likelihood of being alive at five years with an OS rate of 16% versus 8% in the control arm (HR 0.67), and a median OS of 21.6 vs. 16.9 months, respectively. The OS benefit with KIMMTRAK was observed regardless of known baseline characteristics including poor prognostic factors (high tumor burden; elevated lactate dehydrogenase [LDH]) or tumor location. Data also confirmed OS benefit was primarily driven by KIMMTRAK rather than subsequent therapies. 2L+ advanced cutaneous melanoma Enrollment in the registrational Phase 3 TEBE-AM trial, evaluating tebentafusp as monotherapy, and in combination with pembrolizumab, versus a control arm in patients with previously treated advanced CM, is nearing the target of 540 patients. The trial is event driven and topline data could come as early as the end of 2026. There is great unmet need in second- and later-line CM, with no therapy having shown an OS improvement post checkpoint inhibitors in a randomized clinical trial to date. The Company estimates there are up to 4,000 previously treated advanced HLA-A*02:01 positive CM patients in the US and Europe. Adjuvant uveal (or ocular) melanoma The European Organisation for Research and Treatment of Cancer (EORTC) continues to expand the site footprint of the Phase 3 Adjuvant Trial in Ocular Melanoma (ATOM), with patients now enrolling in the United States. The Company estimates the HLA-A*02:01 positive, high-risk adjuvant uveal melanoma patient population could represent up to 1,200 patients in the US and Europe. PRAME portfolio Brenetafusp is the Company’s lead PRAME-A02 ImmTAC bispecific candidate. Brenetafusp is being evaluated in combination with nivolumab in a Phase 3 registrational trial (PRISM-MEL-301) in patients with first-line, advanced cutaneous melanoma, and in a Phase 1/2 clinical trial as monotherapy and in combination across multiple tumor types, including ovarian cancer and non-small cell lung cancer (NSCLC). PRISM-MEL-301 – First PRAME Phase 3 clinical trial with brenetafusp in first-line advanced cutaneous melanoma The Company continues with 1:1 randomization of HLA-A*02:01 positive, first-line, advanced or metastatic cutaneous melanoma patients to brenetafusp 160 mcg + nivolumab or a control arm of either nivolumab or nivolumab + relatlimab. Despite approved therapies, there remains an unmet need for improved progression-free survival and OS in the first-line setting where there is the potential to address an estimated 10,000 HLA-A*02:01 positive patients across US and Europe. Phase 1/2 clinical trials of brenetafusp and IMC-P115C (PRAME-A02 Half-Life Extended) in multiple solid tumors Melanoma The Phase 1/2 data, presented at the 2026 ASCO meeting, showed improved clinical activity of brenetafusp monotherapy, in patients with heavily-pretreated advanced melanoma, with an overall response rate (ORR) of 17% and a disease control rate (DCR) of 67%, in the 160 mcg versus 40 mcg cohort (ORR 6% and DCR 56%), despite patients on the high dose having less favorable prognostic factors. These data support the selected dose for the ongoing Phase 3 PRISM-MEL-301 trial in first-line advanced melanoma. The median OS for brenetafusp monotherapy of 14.3 months was similar to other Phase 1/2 trials of combination therapies in heavily pre-treated patients with advanced melanoma, including studies with autologous cell therapies. Brenetafusp in combination with pembrolizumab (n=6) demonstrated promising clinical activity with ORR of 33% and DCR 67% in patients with PD1 primary resistance (defined as progressive disease within 6 months of starting first PD1-based regimen). Brenetafusp was generally well tolerated as monotherapy and in combination with pembrolizumab. Other tumors and IMC-P115C After observing an initial brenetafusp monotherapy signal in platinum-resistant ovarian cancer (PROC), the Company is evaluating, as part of an ongoing Phase 1/2 trial, combination therapy with bevacizumab in earlier lines, including platinum-sensitive ovarian cancer (PSOC). In the same trial, the Company continues signal detection across multiple metastatic non-small cell lung cancer (NSCLC) cohorts, including combinations with standards of care in earlier-line NSCLC. The Company is enrolling patients in the Phase 1 dose escalation trial evaluating IMC-P115C in patients with multiple solid tumors. The Company expects to present Phase 1/2 data from both trials in the second half of 2026. ImmTAV candidates for a functional cure in infectious diseases The Company’s bispecific TCR technology platform has the potential to offer a new approach for the treatment of certain chronic infections by eliminating evidence of remaining virus in circulation after the patient stops taking medication – known as a ‘functional cure’. The Company is studying an investigational candidate for people living with human immunodeficiency virus (HIV). Phase 1/2 trial of IMC-M113V (Gag-A02) for people living with HIV In July 2026, at the International AIDS Society meeting in Rio de Janeiro, the Company presented translational data, from the first three cohorts of the multiple ascending dose part of the Phase 1/2 trial, demonstrating that IMC-M113V induces robust type I and II interferon-associated immune programs, with stronger induction in participants who maintained viral control after treatment interruption. The data also showed that, in addition to previously demonstrated direct killing of HIV-infected cells, IMC-M113V redirection of T cells results in induction of a robust interferon-associated immune program that may contribute to post-treatment viral control. The Company completed enrollment of additional patients at higher dose cohorts, up to 1200 mcg, as part of the multiple ascending dose (MAD) part of the Phase 1/2 trial. Analysis of the new data is ongoing with results planned to be shared early next year. Tissue-specific down modulation of the immune system for autoimmune diseasesThe key differentiator of the ImmTAAI platform is down modulation of the immune system in a tissue-specific manner. The candidates achieve this by suppressing pathogenic T cells via PD1 receptor agonism only when tethered to the target tissue. Clinical trial sites for the Phase 1 trial with IMC-S118AI are open, and the Company expects the first type 1 diabetes patient to be dosed in the coming weeks. The Company, in collaboration with the University of Florida, published preclinical data in Science Advances demonstrating that in live human pancreas tissue slices from a recent-onset type 1 diabetes donor, IMC-S118AI selectively binds to HLA-A*02:01-positive beta cells and suppresses autoreactive T cell activity around islets, helping protect beta cells and preserve insulin secretion. IMC-S118AI is designed to bind pre-pro-insulin on beta cells of the pancreas and deliver a PD-1 agonist signal to nearby auto-reactive T cells thereby protecting the pancreatic beta cells from T cell attack while preserving beta cell mass. The Company plans to file a CTA or investigational new drug (IND) application in the second half of 2026 for its second autoimmune program, IMC-U120AI (CD1a x PD1), which is designed to target a variety of dermatological diseases including atopic dermatitis. ### About ImmTAC® molecules for cancerImmunocore’s proprietary T cell receptor (TCR) technology generates a novel class of bispecific biologics called ImmTAC (Immune mobilizing monoclonal TCRs Against Cancer) molecules that are designed to redirect the immune system to recognize and kill cancerous cells. ImmTAC molecules are soluble TCRs engineered to recognize intracellular cancer antigens with ultra-high affinity and selectively kill these cancer cells via an anti-CD3 immune-activating effector function. Based on the demonstrated mechanism of T cell infiltration into human tumors, the ImmTAC mechanism of action holds the potential to treat hematologic and solid tumors, regardless of mutational burden or immune infiltration, including immune “cold” low mutation rate tumors. About ImmTAV® molecules and infectious diseases ImmTAV (Immune mobilizing monoclonal TCRs Against Virus) molecules are novel bispecifics that are designed to enable the immune system to recognize and eliminate virally infected cells. Immunocore is advancing a clinical candidate, aiming to achieve sustained control of HIV after people living with HIV stop anti-retroviral therapy (ART), without the risk of virological relapse or onward transmission. This is known as ‘functional cure’. About ImmTAAITM molecules and autoimmune diseases ImmTAAI (Immune mobilizing monoclonal TCRs Against AutoImmune disease) molecules are novel bispecifics that are designed for tissue-specific down modulation of the immune system. When tethered to the tissue of interest, ImmTAAI candidates suppress pathogenic T cells via PD1 receptor agonism. The Company is currently advancing two candidates for autoimmune diseases, including type 1 diabetes and inflammatory dermatological diseases. About TEBE-AM – Phase 3 registrational trial with tebentafusp in previously treated advanced cutaneous melanoma The trial is randomizing patients with second-line or later advanced cutaneous melanoma who have progressed on an anti-PD1, received prior ipilimumab and, if applicable, received a BRAF kinase inhibitor. Patients are randomized to one of three arms, including tebentafusp – as monotherapy or in combination with an anti-PD1 – or a control arm. The primary endpoint is overall survival. About PRISM-MEL-301 (NCT06112314) – Phase 3 trial with brenetafusp (IMC-F106C, PRAME-A02) in 1L advanced cutaneous melanoma The Phase 3 registrational trial is randomizing HLA-A*02:01-positive patients with previously untreated, advanced or metastatic cutaneous melanoma, to brenetafusp 160 mcg + nivolumab or a control arm of either nivolumab or nivolumab + relatlimab. The primary endpoint of the trial is progression free survival (PFS) by blinded independent central review (BICR), with secondary endpoints of overall survival (OS) and overall response rate (ORR). About the ATOM Phase 3 trial The EORTC-sponsored Phase 3 clinical trial is randomizing HLA-A*02:01-positive patients with high-risk primary uveal melanoma after definitive treatment, by surgery or radiotherapy, and no evidence of metastatic disease on imaging. The trial will randomize patients 1:1 to one of two arms: tebentafusp as monotherapy or observation. The primary endpoint of the trial is relapse-free survival (RFS), with secondary objectives of overall survival and safety and tolerability of tebentafusp. Exploratory objectives include the comparison of the health-related quality of life between the treatment arms and the evaluation of the role of circulating tumor DNA (ctDNA) as a biomarker for the presence of residual disease. About the IMC-F106C-101 Phase 1/2 trial IMC-F106C-101 is a first-in-human, Phase 1/2 dose escalation trial in patients with multiple solid tumors, including non-small cell lung and ovarian cancers, evaluating brenetafusp in combination arms with standards-of-care. The Phase 1 dose escalation trial was designed to determine the maximum tolerated dose (MTD), as well as to evaluate the safety, preliminary anti-tumor activity and pharmacokinetics of IMC-F106C (brenetafusp), a bispecific protein built on Immunocore’s ImmTAC technology, and the Company’s first molecule to target the PRAME antigen. About Uveal Melanoma Uveal melanoma is a rare and aggressive form of melanoma, which affects the eye. This is the most common primary intraocular malignancy in adults and up to 50% of people with uveal melanoma will eventually develop metastatic disease. Unresectable or metastatic uveal melanoma typically has a poor prognosis and had no approved treatment until KIMMTRAK. About Cutaneous Melanoma Cutaneous melanoma (CM) is the most common form of melanoma. It is the most aggressive skin carcinoma and is associated with the vast majority of skin cancer-related mortality. The majority of patients with CM are diagnosed before metastasis but survival remains poor for the large proportion of patients with metastatic disease. Despite recent progress in advanced melanoma therapy, there is still an unmet need for new therapies that improve first-line response rates and duration of response as well as for patients who are refractory to first-line treatments. About KIMMTRAK® KIMMTRAK is a novel bispecific protein comprised of a soluble T cell receptor fused to an anti-CD3 immune-effector function. KIMMTRAK specifically targets gp100, a lineage antigen expressed in melanocytes and melanoma. This is the first molecule developed using Immunocore’s ImmTAC technology platform, designed to redirect and activate T cells to recognize and kill tumor cells. KIMMTRAK has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom. IMPORTANT SAFETY INFORMATION Cytokine Release Syndrome (CRS), which may be serious or life-threatening, occurred in patients receiving KIMMTRAK. Monitor for at least 16 hours following first three infusions and then as clinically indicated. Manifestations of CRS may include fever, hypotension, hypoxia, chills, nausea, vomiting, rash, elevated transaminases, fatigue, and headache. CRS occurred in 89% of patients who received KIMMTRAK, with 0.8% being grade 3 or 4. Ensure immediate access to medications and resuscitative equipment to manage CRS. Ensure patients are euvolemic prior to initiating the infusions. Closely monitor patients for signs or symptoms of CRS following infusions of KIMMTRAK. Monitor fluid status, vital signs, and oxygenation level and provide appropriate therapy. Withhold or discontinue KIMMTRAK depending on persistence and severity of CRS. Skin Reactions Skin reactions, including rash, pruritus, and cutaneous edema occurred in 91% of patients treated with KIMMTRAK. Monitor patients for skin reactions. If skin reactions occur, treat with antihistamine and topical or systemic steroids based on persistence and severity of symptoms. Withhold or permanently discontinue KIMMTRAK depending on the severity of skin reactions. Elevated Liver Enzymes Elevations in liver enzymes occurred in 65% of patients treated with KIMMTRAK. Monitor alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total blood bilirubin prior to the start of and during treatment with KIMMTRAK. Withhold KIMMTRAK according to severity. Embryo-Fetal Toxicity KIMMTRAK may cause fetal harm. Advise pregnant patients of potential risk to the fetus and patients of reproductive potential to use effective contraception during treatment with KIMMTRAK and 1 week after the last dose. The most common adverse reactions (≥30%) in patients who received KIMMTRAK were cytokine release syndrome, rash, pyrexia, pruritus, fatigue, nausea, chills, abdominal pain, edema, hypotension, dry skin, headache, and vomiting. The most common (≥50%) laboratory abnormalities were decreased lymphocyte count, increased creatinine, increased glucose, increased AST, increased ALT, decreased hemoglobin, and decreased phosphate. For more information, please see full Summary of Product Characteristics (SmPC) or full U.S. Prescribing Information (including BOXED WARNING for CRS). About KIMMTRAKConnect Immunocore is committed to helping patients who need KIMMTRAK obtain access via its KIMMTRAKConnect program. The US program provides services with dedicated nurse case managers who provide personalized support, including educational resources, financial assistance, and site of care coordination. To learn more, visit KIMMTRAKConnect.com or call 844-775-2273. About Immunocore Immunocore is a commercial-stage biotechnology company pioneering the development of a novel class of TCR bispecific immunotherapies called ImmTAX – Immune mobilizing monoclonal TCRs Against X disease – designed to treat a broad range of diseases, including cancer, autoimmune diseases and infectious diseases. Leveraging its proprietary, flexible, off-the-shelf ImmTAX platform, Immunocore is developing a deep pipeline in multiple therapeutic areas, including clinical and pre-clinical programs​ in oncology, infectious diseases, and autoimmune diseases. The Company’s most advanced oncology TCR therapeutic, KIMMTRAK, has been approved for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma in the United States, European Union, Canada, Australia, and the United Kingdom. Forward Looking Statements This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as “may”, “will”, “believe”, “expect”, “plan”, “anticipate”, “aim”, “continue”, “target” and similar expressions (as well as other words or expressions referencing future events or circumstances) are intended to identify forward-looking statements. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These statements include, but are not limited to, statements regarding the Company’s ability to reach more patients for KIMMTRAK, including continued U.S. community and global market penetration in mUM, the potential expansion into 2L+ advanced cutaneous melanoma, and the potential expansion into adjuvant uveal melanoma; the Company’s ability to grow and advance its clinical pipeline; the estimated size of the patient populations for the Company’s product candidates; expectations regarding the design, progress, timing, enrollment, randomization, scope, expansion, and results of the Company’s and its collaborators’ existing and planned clinical trials; the timing and sufficiency of clinical trial outcomes to support potential approval of any of the Company’s product candidates or those of, or combined with, its collaboration partners; the expected submission of clinical trial applications or investigational new drug applications; the potential regulatory approval, and expected clinical benefits and availability of the Company’s product candidates; and expectations regarding the timing and amount of sales-related rebate payments. Any forward-looking statements are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual events or results to differ materially and adversely from those set forth in or implied by such forward-looking statements, many of which are beyond the Company’s control. These risks and uncertainties include, but are not limited to, the impact of worsening macroeconomic conditions, including as a result of health epidemics or pandemics, war in Ukraine, the conflict in the Middle East, or global geopolitical tension, on the Company’s business, financial position, strategy and anticipated milestones, including the Company’s ability to conduct ongoing and planned clinical trials; the Company’s ability to obtain a clinical supply of current or future product candidates or commercial supply of KIMMTRAK or any future approved products; the Company’s ability to obtain and maintain regulatory approval of KIMMTRAK and its other product candidates; the Company’s ability and plans in continuing to establish and expand a commercial infrastructure and to successfully launch, market and sell KIMMTRAK and any future approved products; the Company’s ability to successfully expand the approved indications for KIMMTRAK or obtain marketing approval for KIMMTRAK in additional geographies in the future; the delay of any current or planned clinical trials, whether due to patient enrollment delays or otherwise; the Company’s ability to successfully demonstrate the safety and efficacy of its product candidates and gain approval of its product candidates on a timely basis, if at all; competition with respect to market opportunities; unexpected safety or efficacy data observed during preclinical studies or clinical trials; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials or future regulatory approval; the Company’s need for and ability to obtain additional funding, on favorable terms or at all, including as a result of worsening macroeconomic conditions, including changes in inflation and interest rates and unfavorable general market conditions, and the impacts thereon of the war in Ukraine, the conflict in the Middle East, and global geopolitical tension; the Company’s ability to obtain, maintain and enforce intellectual property protection for KIMMTRAK or any of its product candidates it or its collaborators are developing; and the success of the Company’s current and future collaborations, partnerships or licensing arrangements. These and other risks and uncertainties are described in greater detail in the section titled "Risk Factors" in the Company’s filings with the Securities and Exchange Commission, including the Company’s most recent Annual Report on Form 10-K for the year ended December 31, 2025 filed with the Securities and Exchange Commission on February 25, 2026, as well as discussions of potential risks, uncertainties, and other important factors in the Company’s subsequent filings with the SEC. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information, except as required by law. Contact Information Immunocore Sébastien Desprez, VP CommunicationsT: +44 (0) 7458030732E: [email protected] on LinkedIn: @Immunocore Investor RelationsRyan Baker, VP Investor RelationsT: +1 (617) 771 5001 E: [email protected] Immunocore Holdings plcCondensed Consolidated Statement of OperationsComparison of the Quarters and Year to Date Ended June 30, 2026 and 2025 (In thousands, except share and per share data)(Unaudited) Immunocore Holdings plcCondensed Consolidated Balance SheetsAs of June 30, 2026 and December 31, 2025(In thousands)(Unaudited) Immunocore Holdings plcSummary Condensed Consolidated Statements of Cash FlowsFor the Six Months Ended June 30, 2026 and 2025(In thousands)(Unaudited)

This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Kimtrak generated $223 million in net revenue in the first half of 2026, representing 16% growth year-over-year, with strong US performance contributing $75 million in Q2. Five-year overall survival data presented at AACR showed Kimtrak doubles the likelihood of being alive at five years for patients with HLA-A2-positive metastatic uveal melanoma, with a 16% OS rate versus 8% for investigators' choice. The company is advancing three ongoing Phase 3 trials in melanoma (TEBI-AM, ATOM, and PrismMel-301), with TEBI-AM enrollment nearing completion and top-line data expected as early as the end of 2026. Brenetafusp (PRAME) showed promising Phase 1/2 data in heavily pretreated melanoma, with a 17% overall response rate and median overall survival of 14.3 months at the 160-microgram dose, supporting its selection for the Phase 3 trial. The balance sheet remains exceptionally strong with $880 million in cash and marketable securities as of June 30, 2026, providing flexibility for commercial execution and pipeline advancement. The pipeline is diversified beyond oncology, with the first autoimmune candidate (S118AI) for type 1 diabetes entering clinical testing and HIV program progressing with higher dose cohorts, presenting multiple value creation opportunities. Q2 US sales were partially influenced by approximately $6 million in wholesaler stocking, which will create a headwind in Q3, and underlying sequential growth was only 3%. The company expects moderating growth for Kimtrak in its fifth year on the market due to high penetration (over 70% in major markets), limiting future revenue expansion. R&D expenses increased to $74 million in Q2, up from $59 million in the prior year, driven by the advancement of three Phase 3 trials, with expectations for further increases. The company expects to pay approximately $120 million in sales-related rebates during the second half of 2026, which is higher than prior years due to European growth and the French pricing agreement, impacting cash flow. TEBI-AM enrollment is slightly delayed, with the number of patients left to enroll in the 10s, and while top-line data is still expected as early as end of 2026, there is a risk it could slip into 2027. The company faces competitive risk from IDEAYA's oral regimen in uveal melanoma, which could potentially include HLA-positive patients in its initial label, though management downplays the impact. Warning! GuruFocus has detected 3 Warning Signs with IMCR. Is IMCR fairly valued? Test your thesis with our free DCF calculator. Q: For the TEB-AM trial, can you review the study plan regarding the potential interim or final analysis, specifically the potential top-line readout possible by year-end? Is that the first interim OS analysis, and how is it powered?A: Dr. Mohammad Dar (Chief Medical Officer): We don't usually get into specifics of the stats plan, but it's not unusual to have interim analyses designed into a trial. However, just because an interim is written into the protocol doesn't mean we have to execute on it. We do not do any data analysis until enrollment is complete. We remain on track for the earliest possible readout of headline data as early as the end of this year. Q: You are not done enrolling the second-line melanoma trial yet. Is there any risk the timing falls into 2027? If it does, can we presume the ChemTrak arms are doing better versus control? Also, what percent of control patients would be on a clinical trial versus chemo?A: Dr. Mohammad Dar (Chief Medical Officer): It's important to remember that patients being enrolled now typically have very minimal impact on the primary endpoint, which is event-driven overall survival. That's why we reiterate that the earliest possible readout can be as early as the end of this year. Regarding the control arm, based on real-world evidence and experience in the composite trial, the use of clinical trials is very low, typically in the single-digit percentage. Q: For the shape of the enrollment curve for TEB-AM, could you provide more color on how that could lead to event rates being hit for an interim or final analysis later this year? And as we think about the half-life extended PRAME data, what expectations should we have and which data sets from Brenny would be reasonable to compare?A: Dr. Mohammad Dar (Chief Medical Officer): Once all sites are activated, you have steady-state enrollment, which has been our experience. The last patients enrolled typically don't have an impact on the primary endpoint. Regarding the PRAME HLE study, it's a Phase 1 trial where dose escalation continues, and we will share data once we have a complete story. Many of the sites and patient types (melanoma and ovarian) are the same as the Brenny trial, so those are the tumor types to compare across the two trials. Q: We saw ChemTrak US revenues grew 17% year-on-year to $75 million. Does that fall under your definition of moderate growth? Where does US and Europe penetration stand today, and can you provide color on the split between academic centers and community-driven penetration in the US?A: Travis Coy (CFO) and Ralph Torbay (Chief Commercial Officer): The 17% year-on-year growth was partially influenced by an unusual stocking event of about $6 million in the US. We refer to moderating growth mainly in terms of quarterly sequential growth. Penetration is above 70% in the US, with 70% of prescriptions coming from the community. In Europe, penetration is about 75-80% across major markets. Q: On TEB-AM, how are you coming up with the late '26 comment? Are you looking at blinded event rates in the study and how are those trending?A: Dr. Mohammad Dar (Chief Medical Officer): As we get close to enrollment completion, a separate independent stats group looks at the combined event rate. Based on that information, we are guiding that we could have headline data as early as the end of 2026. As we get closer, we can provide an update because the zone of uncertainty becomes more narrow. Q: For TEB-AM in advanced cutaneous melanoma, what proportion of the estimated HLA-positive patient base could you realistically access within the first three years of launch?A: Ralph Torbay (Chief Commercial Officer): The opportunity is up to 4,000 patients across the US and EU. This is an area of high unmet need with little to no approved therapies in this setting, and we would be the first off-the-shelf OS-driven therapy. We expect good uptake, especially since 50% of patients with cutaneous melanoma are currently being treated by physicians experienced with KimTrak. Q: On the sales-related rebate accruals, of the $120 million, what drives the size of payments, and how should we think about normalization in terms of cadence going forward?A: Travis Coy (CFO): Two things contributed to the rebate payments expected in the second half of this year: growing sales in Europe and the pricing agreement with France struck in early 2025, which allowed for cash rebate payments accrued over the prior five years. Moving forward, we expect rebate payments in 2027 to return to similar levels as 2025, which was in the $65 million to $70 million range. Q: Regarding the AACR results and five-year overall survival, do you expect that to have any impact on duration of therapy, which sits around 14 months for KimTrak?A: Ralph Torbay (Chief Commercial Officer): The five-year results themselves will probably not have an impact, but they allow us to see why we have a 14-month duration of therapy. For instance, 44% of patients alive at five years only saw KimTrak as their treatment, speaking to long-term safety and efficacy. We will reinforce this message, but we don't expect to drive the 14 months beyond what we've seen as it has been stable for the past few quarters. Q: Can you speak to the extent to which IDEAYA's oral regimen is a competitive risk to KimTrak in uveal melanoma, especially if they get HLA-positive patients into their initial label?A: Ralph Torbay (Chief Commercial Officer): This is good news for HLA-A02:01 negative patients who currently have significant unmet need. For HLA-A02:01 positive patients, KimTrak is the standard of care across all major markets, underpinned by five-year overall survival data and exceptional safety. With KimTrak, you're getting OS and tolerable safety for years, so I see KimTrak being very much anchored in first line. Q: Could you discuss your internal bar in ovarian cancer in the context of all the ADCs in development? What would you need to see to progress development in that setting?A: Dr. Mohammad Dar (Chief Medical Officer): The growth of ADCs highlights the unmet need in this disease. ADCs are essentially targeted chemotherapy, and For the complete transcript of the earnings call, please refer to the full earnings call transcript.

This article first appeared on GuruFocus. Release Date: August 06, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Kimtrak generated $223 million in net revenue in the first half of 2026, representing 16% year-over-year growth, with strong US performance contributing $75 million in Q2. Five-year overall survival data presented at AACR showed Kimtrak doubles the likelihood of survival at five years (16% vs 8%) for HLA-A2-positive metastatic uveal melanoma, with survival curves separating early and remaining durable. The company is advancing three Phase 3 trials in melanoma (TEBI-AM, ATOM, PrismMel-301), with TEBI-AM enrollment nearing completion and top-line data expected as early as end of 2026. Brenetafusp (PRAME) showed promising Phase 1/2 data in heavily pretreated melanoma, with a 17% overall response rate and median overall survival of 14.3 months at the 160-microgram dose, supporting its selection for the Phase 3 trial. The balance sheet remains exceptionally strong with $880 million in cash and marketable securities, providing flexibility to support commercial execution and pipeline advancement. The pipeline is diversified beyond oncology, with the first autoimmune candidate (S118AI) in type 1 diabetes entering clinical testing and HIV program advancing with higher dose cohorts. Q2 US sales were partially inflated by approximately $6 million in wholesaler stocking, which will create a headwind in Q3, and underlying sequential growth was only 3%. The company expects moderating growth for Kimtrak in its fifth year on the market due to high penetration (over 70% in major markets), limiting future expansion potential. R&D expenses increased significantly to $74 million in Q2 (from $59 million in the prior year) due to advancing multiple Phase 3 trials, with expectations of further increases. The company expects to pay approximately $120 million in sales-related rebates in the second half of 2026, primarily due to the French pricing agreement, impacting cash flow despite revenue growth. TEBI-AM enrollment has been slightly delayed, and while the company reiterates end-of-2026 data readout, there is inherent risk of falling into 2027 if event rates are not met. The HIV program data will not be shared until early 2027, and the company has not yet reached a maximum tolerated dose, indicating uncertainty about the optimal dosing and efficacy. Warning! GuruFocus has detected 3 Warning Signs with IMCR. Is IMCR fairly valued? Test your thesis with our free DCF calculator. Q: For the TEB-AM trial, can you review the study plan regarding potential interim or final analyses, specifically the potential top-line readout possible by year-end? Is that the first interim OS analysis, and how is it powered?A: Mohamed Dar, Chief Medical Officer: We don't usually get into specifics of the stats plan, but it's not unusual to have interim analyses designed into a trial. However, just because an interim is written into the protocol doesn't mean we have to execute on it. The trial was designed so we don't do any data analysis until enrollment is complete. We remain on track for the earliest possible readout of headline data as early as the end of this year. Q: Regarding the second-line melanoma trial, is there any risk the year-end timing falls into 2027? If so, can we presume the Kimtrak arms are doing better versus control? Also, what percent of control patients would be on a clinical trial versus chemo?A: Mohamed Dar, Chief Medical Officer: Patients being enrolled now typically have minimal impact on the primary endpoint, which is event-driven overall survival. That's why we reiterate the earliest possible readout can be as early as the end of this year. Regarding the control arm, based on real-world evidence and experience in the composite trial, the use of clinical trials is very low, typically in the single-digit percentage. Q: For the shape of the enrollment curve for TEB-AM, how could that lead to event rates being hit for an interim or final analysis later this year? And for the half-life extended PRAME data, what expectations should we have and which datasets from Brenetafusp would be reasonable to compare?A: Mohamed Dar, Chief Medical Officer: Once all sites are activated, you have steady-state enrollment. The last patients enrolled, even with a few weeks delay, typically don't impact the primary endpointthe impact comes from patients enrolled much earlier. For the PRAME HLE study, it's a Phase 1 trial where dose escalation continues, and we will share data once we have a complete story. Many sites and patient types (melanoma and ovarian) overlap between the Brenetafusp and HLE trials, making those the best comparisons. Bahija Jalal, CEO, added that the molecule is almost exactly the same except for the half-life extension portion. Q: Kimtrak US revenues grew 17% year-on-year to $75 million. Does that fall under your definition of moderate growth? Where does US and Europe penetration stand, and can you provide color on the split between academic and community settings?A: Travis Coy, CFO: Year-on-year growth is one thing, but given we're in the 5th year on the market with high penetration, we've seen quarterly sequential growth moderate, which is what we refer to as moderating growth. Ralph Torbay, Chief Commercial Officer: The 17% was partly driven by an unusual stocking event of about $6 million in the US. Penetration is above 70% in the US, with 70% of prescriptions coming from the community. In Europe, penetration is about 75-80%. Q: On TEB-AM, how are you coming up with the late 2026 comment? Are you looking at blinded event rates, and how are those trending?A: Mohamed Dar, Chief Medical Officer: As we get close to enrollment completion, a separate independent stats group looks at the combined event rate. Based on that information, we guide that headline data could be as early as the end of 2026. As we get closer, we can provide an update because the zone of uncertainty becomes more narrow. Q: For TEB-AM in advanced cutaneous melanoma, what proportion of the estimated HLA-positive patient base could you realistically access within the first three years of launch?A: Ralph Torbay, Chief Commercial Officer: The opportunity is up to 4,000 patients across the US and EU who are HLA-A02:01-positive. This is an area of high unmet need with little to no approved therapies, and we would be the first off-the-shelf OS-driven therapy. We expect good uptake, especially since 50% of patients with cutaneous melanoma are already being treated by physicians experienced with Kimtrak. Q: On the sales-related rebate accruals of $120 million, what drives the size of payments, and how should we think about normalization in cadence going forward?A: Travis Coy, CFO: Two things contributed: growing sales in Europe and the pricing agreement with France struck in early 2025, which allowed for cash rebate payments accrued over the prior five years to be payable this year. Moving forward, we expect rebate payments in 2027 to return to similar levels as 2025, which was in the $65 million to $70 million range. Q: Regarding the AACR five-year overall survival results, do you expect that to impact duration of therapy, which sits around 14 months?A: Ralph Torbay, Chief Commercial Officer: The five-year results themselves will probably not have an impact, but they allow us to see why we have a 14-month duration. For instance, 44% of patients alive at five years only saw Kimtrak as their treatment, speaking to long-term safety and efficacy. We will reinforce this message, but we don't expect to drive the 14 months beyond what we've seen as it's been stable for the past few quarters. Q: Can you speak to the extent IDEAYA's oral regimen is a competitive risk to Kimtrak in uveal melanoma, especially if they get HLA-positive patients into their initial label?A: Ralph Torbay, Chief Commercial Officer: This is good news for HLA-A02:01 negative patients who currently have significant unmet need. For HLA-A02:01 positive patients, Kimtrak is the standard of care across all major markets, underpinned by five-year overall survival data and exceptional safety. With Kimtrak, you're getting OS and tolerable safety for years, so I see Kimtrak being very much anchored in first line. Q: For Brenetafusp in ovarian cancer, what is your internal bar in the context of ADCs and the ematics data seen at ASCO? What would you need to see to progress development?A: Mohamed Dar, Chief Medical Officer: The growth of ADCs highlights the unmet need. ADCs are essentially targeted chemotherapy, and our platform has a unique mechanism with For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Interested in Immunocore Holdings PLC Sponsored ADR? Here are five stocks we like better. KIMMTRAK sales continued to grow: First-half net sales reached $223 million, up 16% year over year, while second-quarter sales rose 18% to $116 million. However, U.S. sales benefited from approximately $6 million in wholesaler stocking, creating a third-quarter headwind. Melanoma pipeline progress remains central: Enrollment in the Phase III TEBE-AM trial is nearly complete, with headline data potentially available by the end of 2026. Immunocore is also advancing the ATOM adjuvant uveal melanoma study and the PRISM-MEL-301 trial of brenetafusp in first-line cutaneous melanoma. Financial position remains strong despite higher rebates: Immunocore held $880 million in cash and marketable securities at the end of June and nearly broke even in the second quarter. The company expects approximately $120 million in sales-related rebate payments during the second half of 2026, primarily tied to European revenue and a French pricing agreement. Growth Picks: 3 Low-Cost Stocks That Could Double in Value Immunocore (NASDAQ:IMCR) reported continued growth for KIMMTRAK in the second quarter and first half of 2026, while advancing three late-stage melanoma trials and early-stage programs in oncology, HIV and Type 1 diabetes. The company recorded $223 million in KIMMTRAK net sales during the first half, up 16% from the prior-year period. Second-quarter net sales were $116 million, an 18% increase from the second quarter of 2025. The United States contributed $75 million in quarterly sales, Europe generated $34 million and international markets accounted for $7 million. → 3 Drone Stocks That Should Soar After the Summer Slump 3 Fast-Growing Stocks Analysts See Doubling in Price Chief Financial Officer and Head of Corporate Development Travis Coy said U.S. sales included approximately $6 million of wholesaler inventory stocking, which will create a headwind in the third quarter. Excluding that stocking effect, underlying sequential quarterly growth was 3%, which Coy said aligned with the company’s expectation for moderating sales growth as market penetration remains high. Chief Commercial Officer Ralph Torbay said KIMMTRAK has reached more than 70% penetration in major markets, including the United States, where 70% of prescriptions come from community settings. Penetration in European countries is approximately 75% to 80%, he said. Duration of therapy has remained stable at about 14 months. → Meta’s Earnings Drop Shows Wall Street Wants More Than Ad Growth Institutions are Buying These 3 Stocks and Analysts Agree At the American Association for Cancer Research meeting in April, Immunocore presented five-year overall survival data from KIMMTRAK’s registrational trial in HLA-A*02:01-positive first-line metastatic uveal melanoma. The company said the five-year overall survival rate was 16% for KIMMTRAK-treated patients, compared with 8% for patients receiving investigator’s choice. Torbay said 44% of patients alive at five years in the KIMMTRAK arm had received KIMMTRAK as their only treatment. In the control group, 87% of patients alive at five years had crossed over to KIMMTRAK. The survival benefit was observed across subgroups including patients with high tumor burden, elevated LDH and extrahepatic disease, according to the company. → Jersey Mike's Serves Fresh Gains After IPO Stumble Immunocore said it currently serves about 1,000 patients annually in metastatic uveal melanoma and sees an opportunity to expand the addressable patient population through lifecycle-management studies in cutaneous melanoma and adjuvant uveal melanoma. The company’s lead registrational opportunity is the Phase III TEBE-AM trial in advanced cutaneous melanoma. The study is evaluating KIMMTRAK alone, KIMMTRAK plus pembrolizumab, and a control arm in patients who progressed following checkpoint inhibitors and, where applicable, targeted therapy. The primary endpoint is overall survival. Chief Medical Officer Mohammed Dar said enrollment is nearing the 540-patient target, with the remaining number of patients “in the teens.” He reiterated that headline data could be available as early as the end of 2026. Dar said the company uses a separate independent statistical group to monitor the combined blinded event rate as the study approaches enrollment completion. The company cited Phase Ib data in which KIMMTRAK showed a 75% one-year survival rate in heavily pretreated advanced melanoma, compared with a historical benchmark of approximately 55%. Dar also noted that no treatment has demonstrated an overall-survival benefit in the second-line-plus cutaneous melanoma setting following checkpoint inhibitors and targeted therapy. Immunocore’s ATOM study, sponsored by the European Organisation for Research and Treatment of Cancer, is enrolling high-risk uveal melanoma patients in the adjuvant setting. Patients are randomized to KIMMTRAK or observation, with relapse-free survival as the primary endpoint. The trial is enrolling in Europe and the United States. The company is also conducting the Phase III PRISM-MEL-301 trial of brenetafusp plus nivolumab in first-line cutaneous melanoma. The study compares the combination with nivolumab alone or nivolumab plus relatlimab, using progression-free survival as its primary endpoint. More than 200 sites have been activated globally, and Immunocore is targeting enrollment completion by late 2027. In previously presented Phase I/II data, brenetafusp monotherapy at a 160-microgram dose produced a 17% overall response rate and 67% disease control rate in heavily pretreated advanced melanoma, with median overall survival of 14.3 months. The company said the results supported use of the 160-microgram dose in PRISM-MEL-301. Beyond melanoma, Immunocore expects to present updated brenetafusp data in ovarian cancer and non-small cell lung cancer later in 2026. In ovarian cancer, the company is evaluating combinations with chemotherapy in platinum-resistant disease and with bevacizumab in platinum-sensitive maintenance treatment. In lung cancer, the company is seeking monotherapy signals across molecular subsets and evaluating combinations with standards of care. The company is also studying a half-life-extended PRAME candidate in a Phase I dose-escalation trial. Dar said the molecule is intended to offer less frequent dosing and could potentially improve response rates. Immunocore plans to determine next steps based on emerging data. In HIV, the company has completed enrollment of additional patients in higher-dose cohorts of its Phase I/II multiple-ascending-dose study, including a 1,200-microgram cohort. Immunocore plans to share results in the first half of 2027. Earlier data had shown delayed viral rebound following treatment interruption in a small number of participants at higher doses. Immunocore also said its Phase I Type 1 diabetes study is open and screening patients, with the first patient expected to be dosed in coming weeks. Its IMC-S118AI candidate targets preproinsulin expressed on pancreatic beta cells, and the study will assess target engagement and immune modulation using C-peptide levels. Second-quarter research and development expense rose to $74 million from $69 million a year earlier, primarily reflecting advancement of the company’s clinical programs. Selling, general and administrative expense was $44 million, compared with $43 million in the prior-year quarter. Immunocore reported a net loss of just under $1 million for the quarter, improving from a $10 million loss a year earlier. As of June 30, the company held $880 million in cash and marketable securities, up $16 million from the beginning of the year. Coy said Immunocore expects to pay approximately $120 million in sales-related rebates during the second half of 2026. The amount reflects European revenue growth and a French pricing agreement reached in early 2025 that requires payment of rebates accrued over the prior five years. The company expects rebate payments in 2027 to return to levels similar to 2025, when payments were approximately $65 million to $70 million. Immunocore plc is a clinical‐stage biotechnology company focused on the development of novel immunotherapies that harness the body's own T‐cell response to treat cancer and infectious diseases. The company's proprietary ImmTAC (immune mobilising monoclonal T‐cell receptors against cancer) platform utilizes engineered, soluble T‐cell receptor (TCR) molecules designed to recognise intracellular peptide–HLA complexes. By redirecting and activating T cells against disease‐associated targets, Immunocore aims to address malignancies and persistent viral infections with high unmet medical need. The company's most advanced candidate, tebentafusp, is a bispecific ImmTAC molecule that targets gp100, a melanoma‐associated antigen, and has received regulatory approval for the treatment of metastatic uveal melanoma. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Immunocore Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.

Sanofi SNY announced that it is discontinuing the phase III MOBILIZE study, which is evaluating its investigational drug, riliprubart, in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) refractory to standard-of-care (SoC) treatment. This decision comes after an independent committee conducted an interim analysis of the data from the MOBILIZE study and concluded that riliprubart was “unlikely to provide sufficient efficacy” in this difficult-to-treat patient population. The analysis did not identify any new safety concerns associated with the drug. With this setback, Sanofi stated that it will assess the future of other ongoing riliprubart studies, including the phase III VITALIZE study in CIDP patients receiving maintenance intravenous immunoglobulin (IVIg) therapy. CIDP is a rare disorder affecting the peripheral nervous system, marked by progressive muscle weakness and sensory loss. Following this announcement, Sanofi's shares were trading lower in pre-market trading today. While the company assured investors that the MOBILIZE study termination does not affect its financial outlook for 2026, the setback raises concerns about the future of riliprubart, which was previously viewed as one of its promising pipeline candidates. Sanofi had previously outlined plans for a regulatory filing in 2027 based on data from the MOBILIZE and VITALIZE studies. The drug has also secured orphan drug designation in both the United States and Europe for CIDP. Although VITALIZE remains ongoing, the loss of one pivotal study raises uncertainty about riliprubart's regulatory and commercial prospects. Year to date, the stock has lost nearly 8% against the industry’s 4% growth. Image Source: Zacks Investment Research An investigational IgG4 humanized monoclonal antibody, riliprubart, is designed to selectively inhibit activated C1s in the classical complement pathway of the innate immune system. Apart from CIDP, Sanofi is assessing riliprubart in a phase II study for antibody-mediated rejection (AMR) in kidney transplant recipients. The study is evaluating the drug in patients at risk of developing AMR as well as those with active AMR, reflecting the company's efforts to explore the therapy's potential across multiple immune-mediated diseases. Sanofi currently carries a Zacks Rank #3 (Hold). Sanofi price | Sanofi Quote Some better-ranked stocks from the sector are Immunocore IMCR and Indivior Pharmaceuticals INDV, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here. Over the past 60 days, estimates for Immunocore’s 2026 bottom line have improved from a loss per share of 88 cents to earnings of 6 cents. Over the same period, estimates for 2027 EPS have risen from 24 cents to 87 cents. IMCR’s shares have lost 18% year to date. Immunocore’s earnings beat estimates in three of the trailing four quarters but missed the mark on one occasion, delivering an average surprise of 46.66%. Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 EPS have increased from $3.33 to $4.05. Over the same period, EPS estimates for 2027 have risen from $3.66 to $4.27. INDV’s shares are up nearly 7% year to date. Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 65.44%. 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 Sanofi (SNY) : Free Stock Analysis Report Immunocore Holdings PLC Sponsored ADR (IMCR) : Free Stock Analysis Report Indivior Pharmaceuticals Inc. (INDV) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Shares of BioMarin Pharmaceutical BMRN were down 4% on Monday after it reported results from the phase III ENERGY 3 study, which evaluated BMN 401, an investigational enzyme replacement therapy (ERT), for a rare genetic disorder called ENPP1 deficiency in children aged 1 to 12. The study did not meet one of its two main goals. The mixed results were a setback for BioMarin, which added BMN 401 through its $270 million acquisition of Inozyme Pharma last year. This ERT was the lead asset in Inozyme’s pipeline, and the ENERGY 3 study was already underway at the time of the acquisition. Year to date, the stock has lost 16% compared with the industry’s 3% fall. Image Source: Zacks Investment Research The study assessed two primary endpoints — changes in plasma inorganic pyrophosphate (PPi) and Radiographic Global Impression of Change (RGI-C) scores after 52 weeks of treatment. While treatment with BMN 401 after 52 weeks resulted in statistically significant increases in plasma PPi, there was no corresponding improvement in RGI-C scores. An increase in plasma PPi is considered an important biomarker response because ENPP1 deficiency leads to low PPi levels, which can result in progressive damage to blood vessels, soft tissues and bones. However, BMN 401 failed to demonstrate improvement in RGI-C scores, a key measure used to assess treatment impact in children with rickets. The lack of radiographic improvement suggests that the biomarker gains did not translate into measurable skeletal benefits during the study period. The therapy also did not show positive trends across secondary endpoints, including Rickets Severity Score (RSS), a measure of rickets severity, and growth Z-scores evaluating height/body length and weight. BioMarin stated that it will continue analyzing the complete ENERGY 3 dataset and engage with global regulatory authorities to determine the next steps for BMN 401’s development program. The company also plans to present detailed findings from the study at a future medical meeting. The stock currently carries a Zacks Rank #3 (Hold). BioMarin Pharmaceutical Inc. price | BioMarin Pharmaceutical Inc. Quote Some better-ranked stocks from the sector are Immunocore IMCR and Indivior Pharmaceuticals INDV, 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 30 days, estimates for Immunocore’s 2026 loss per share have narrowed from 97 cents to 16 cents. Over the same period, estimates for 2027 have improved from a loss of 39 cents to earnings of 11 cents. IMCR shares have lost 18% year to date. Immunocore’s earnings beat estimates in three of the trailing four quarters but missed the mark on one occasion, delivering an average surprise of 46.66%. Over the past 30 days, estimates for Indivior Pharmaceuticals’ 2026 EPS have increased from $3.10 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.47. INDV shares have risen 2% year to date. Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 65.44%. 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 BioMarin Pharmaceutical Inc. (BMRN) : Free Stock Analysis Report Immunocore Holdings PLC Sponsored ADR (IMCR) : Free Stock Analysis Report Indivior Pharmaceuticals Inc. (INDV) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

CorMedix Therapeutics CRMD delivered first-quarter 2026 diluted earnings of 43 cents per share, up 43.3% year over year, beating the Zacks Consensus Estimate of 35 cents. Net revenue was $127.4 million, up significantly from the year-ago sales of $39.08 billion. The reported figure beat the Zacks Consensus Estimate of $110 million. Results reflected stronger DefenCath execution and underlying demand trends, with DefenCath net revenues of $97.5 million in the quarter. Management also lifted its full-year outlook following the better-than-expected start to 2026. The stock gained 5.7% on Thursday following the earnings release. DefenCath remained the key operating lever in the period, supported by higher utilization among outpatient dialysis customers. Its sales increased, primarily boosted by the onboarding of a large dialysis organization in mid-2025, along with strong positive demand trends. Quarterly DefenCath performance also benefited from a favorable change in estimate tied to certain sales allowances, including items such as Medicaid rebates and product returns. While that impact provided a lift, management pointed to underlying utilization momentum as the more important signal on demand durability. The Melinta portfolio contributed $29.9 million in the first quarter. Its acquisition in the last year added a meaningful second revenue stream and broadened CorMedix’s commercial footprint. The Melinta contribution also changed the year-over-year comparison framework for CorMedix, given that the acquisition occurred in August 2025. As a result, the year-ago period reflected revenue from only DefenCath, making the current quarter’s mix and scale structurally different. Shares of CorMedix have plunged 31.9% so far this year against the industry’s 1.1% growth. Image Source: Zacks Investment Research Operating expenses increased sharply year over year as the company absorbed a larger cost base following the Melinta acquisition. Total operating expenses were $41.5 million, up 138.5% from the prior-year quarter, which management attributed primarily to expenses related to the acquired portfolio and the broader combined-company footprint. R&D expenses climbed to $7.2 million, up 125% year over year, due to higher personnel spending and clinical trial services tied to ongoing programs, including pediatric studies for certain brands and continued DefenCath development work. Commercial and corporate costs also rose with scale, as selling and marketing expenses increased significantly to $12.5 million and general and administrative expenses rose abruptly to $21.7 million, reflecting the expanded portfolio and related operating requirements. Management raised its full-year 2026 net revenue outlook to the range of $325-$345 million from $300-$320 million, citing strong first-quarter execution and continued confidence in underlying demand. The revised range represents an increase from CRMD’s previously established revenue expectations. CorMedix also increased full-year adjusted EBITDA guidance to a range of $115-$135 million from $100-$125 million. The updated profitability view suggests management expects operating leverage to continue as the company integrates the broader product set and sustains DefenCath utilization growth. CorMedix highlighted progress across its late-stage pipeline in the first-quarter earnings release. Last month, the company announced positive phase III top-line results from the global ReSPECT clinical study evaluating Rezzayo (rezafungin for injection) for prophylaxis of invasive fungal diseases in adult patients undergoing allogeneic hematopoietic stem cell transplantation. CorMedix said it is working with its global partner to prepare a supplemental new drug application expected to be submitted in the second half of this year, with a potential commercial launch for the expanded indication in 2027. CorMedix also provided an update on its ongoing phase III study of taurolidine/heparin catheter lock solution in total parenteral nutritionpatients, which continues to enroll and is currently trending to completion in 2028. Management noted it is taking steps to accelerate enrollment, including opening new study sites and submitting a protocol amendment to the FDA that, if approved, would remove certain exclusion criteria and broaden patient enrollment. CorMedix Inc price-consensus-eps-surprise-chart | CorMedix Inc Quote CorMedix currently carries a Zacks Rank #4 (Sell). Some better-ranked stocks in the biotech sector are Amarin Corporation AMRN, Indivior Pharmaceuticals INDV and Immunocore IMCR, 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 Amarin’s 2026 loss per share have narrowed from $7.01 to $6.36. Over the same period, loss per share estimates for 2027 have also narrowed from $5.50 to $4.64. AMRN shares have risen 5.9% year to date. Amarin’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 50.02%. Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.03 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.46. INDV shares have risen 5.4% year to date. Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%. Over the past 60 days, estimates for Immunocore’s 2026 loss per share have narrowed from 97 cents to 16 cents. On the other hand, its 2026 EPS is currently pegged at 11 cents. IMCR shares have lost 17.2% year to date. Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%. 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 Amarin Corporation PLC (AMRN) : Free Stock Analysis Report CorMedix Inc (CRMD) : Free Stock Analysis Report Immunocore Holdings PLC Sponsored ADR (IMCR) : Free Stock Analysis Report Indivior Pharmaceuticals Inc. (INDV) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Catalyst Pharmaceuticals CPRX reported adjusted earnings of 79 cents per share for the first quarter of 2026, beating the Zacks Consensus Estimate of 64 cents. The company had recorded adjusted earnings of 68 cents in the year-ago quarter. Total revenues, the majority of which comprised product revenues, amounted to $149.4 million in the reported quarter, representing growth of 6% year over year. The recorded figure also surpassed the Zacks Consensus Estimate of $147 million. Catalyst Pharmaceuticals’ top line primarily comprised revenues from the sale of Firdapse, the first approved drug for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) and the newer muscle disease drug, Agamree (vamorolone). Revenues generated from the sale of CPRX’s epilepsy drug Fycompa (perampanel) CIII also contributed to the top line. Firdapse generated sales worth $98.86 million in the reported quarter, up 18% year over year, driven by organic sales growth. The reported figure marginally missed the Zacks Consensus Estimate of $98.9 million. The drug has been witnessing strong demand, increasing prescription rates from LEMS patients and continued diagnosis of new LEMS patients. In 2023, Catalyst Pharmaceuticals acquired exclusive rights to manufacture and supply Agamree from Santhera Pharmaceuticals through a licensing agreement. In late 2023, the FDA approved Agamree for treating Duchenne Muscular Dystrophy in patients aged two years and older, which gave the company a third approved product. The drug was commercially launched in the United States in the middle of March 2024. In the reported quarter, Agamree generated revenues worth $36.7 million, up 67% year over year. The reported figure beat the Zacks Consensus Estimate of $35 million. Year to date, Catalyst Pharmaceuticals shares have gained 33.5% against the industry’s 4.7% decline. Image Source: Zacks Investment Research In 2023, Catalyst Pharmaceuticals acquired the U.S. rights for Fycompa (perampanel) CIII from Eisai Co., Ltd. This acquisition diversified the company’s portfolio by adding a commercial-stage epilepsy asset. Catalyst Pharmaceuticals started recording sales of Fycompa in 2023. Fycompa generated net product revenues of $13.8 million, down 61% year over year, as tablet generics began hitting the market in May 2025 following the expiration of its first U.S. patent, with another slated to expire in July 2026. Catalyst Pharmaceuticals also lost exclusivity for the oral suspension version of Fycompa in December 2025. As a result, revenues from this product are expected to further decline in future periods as additional generic competition enters the market. The reported figure beat the Zacks Consensus Estimate of $13.1 million. Research and development expenses were $2.7 million in the reported quarter, down 32% year over year. Selling, general and administrative expenses totaled $49.3 million, up 5% year over year. As of March 31, 2026, Catalyst Pharmaceuticals had cash, cash equivalents and investments worth $755.9 million compared with $709.2 million as of Dec. 31, 2025. Last week, Catalyst Pharmaceuticals announced settling patent litigation related to Firdapse with Hetero Labs and affiliated companies. The dispute stemmed from Hetero’s abbreviated new drug application seeking approval to market a generic version of the 10 mg tablets before the expiration of relevant patents. Under the settlement, Hetero has received a license to launch a generic version of Firdapse in the United States beginning in January 2035, subject to FDA approval and certain customary exceptions. The agreement also ends all ongoing patent litigation between CPRX, its licensor SERB and Hetero in the U.S. District Court for the District of New Jersey ahead of a scheduled May 2026 trial. It had previously reached similar settlements with Lupin, Teva and Inventia Healthcare regarding generic Firdapse applications. With the Hetero agreement, the company said all pending patent litigation tied to Firdapse has now been resolved. The confidential settlement will be submitted to U.S. antitrust authorities for regulatory review, as required by law. Catalyst Pharmaceuticals is set to be acquired by Angelini Pharma in an all-cash deal valued at about $4.1 billion (€3.5 billion), marking the Italian drugmaker’s entry into the U.S. market. Under the agreement, Catalyst shareholders will receive $31.50 per share in cash, representing a 28% premium to its 30-day volume-weighted average price. The boards of both companies unanimously approved the transaction, which is expected to close in the third quarter of 2026, subject to shareholder and regulatory approvals. The acquisition strengthens Angelini Pharma’s focus on brain health and rare neurological diseases by adding Catalyst’s portfolio of approved therapies, including Firdapse for LEMS, Agamree for Duchenne muscular dystrophy and Fycompa for epilepsy. Angelini Pharma plans to combine CPRX’s U.S. commercial infrastructure with its own neuroscience expertise to expand its rare disease platform and broaden its North American presence while maintaining its manufacturing and research footprint in Italy. Catalyst Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Catalyst Pharmaceuticals, Inc. Quote Catalyst Pharmaceuticals currently carries a Zacks Rank #2 (Buy). Some other top-ranked stocks in the biotech sector are Amarin Corporation AMRN, Indivior Pharmaceuticals INDV and Immunocore IMCR, 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 Amarin’s 2026 loss per share have narrowed from $7.01 to $6.36. Over the same period, loss per share estimates for 2027 have also narrowed from $5.50 to $4.64. AMRN shares have risen 7.6% year to date. Amarin’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 50.02%. Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.03 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.46. INDV shares have risen 8.2% year to date. Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%. Over the past 60 days, estimates for Immunocore’s 2026 loss per share have narrowed from 97 cents to 50 cents. On the other hand, its 2026 EPS is currently pegged at 11 cents. IMCR shares have lost 16.9% year to date. Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%. 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 Amarin Corporation PLC (AMRN) : Free Stock Analysis Report Catalyst Pharmaceuticals, Inc. (CPRX) : Free Stock Analysis Report Immunocore Holdings PLC Sponsored ADR (IMCR) : Free Stock Analysis Report Indivior Pharmaceuticals Inc. (INDV) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research

Make better investment decisions with Simply Wall St's easy, visual tools that give you a competitive edge. Immunocore Holdings (IMCR) just posted Q1 2026 earnings that combined higher KIMMTRAK driven revenue with increased net income, while also releasing five year survival data from a pivotal metastatic uveal melanoma trial. See our latest analysis for Immunocore Holdings. Despite the strong Q1 2026 earnings update and new five year survival data for KIMMTRAK, Immunocore Holdings’ share price return has been mixed, with a 9.7% 7 day gain but a 9.4% year to date decline, and a 3 year total shareholder return decline of 48%, highlighting that longer term holders have experienced pressure even as sentiment has recently improved. If you are weighing this kind of rebound against other healthcare opportunities, it can help to compare Immunocore with peers exposed to similar themes via a focused screener such as 35 healthcare AI stocks With earnings growing, new five year survival data for KIMMTRAK, and the stock still below analyst targets, investors may question whether Immunocore is trading at a discount or if the market is already pricing in future growth. With Immunocore Holdings closing at $30.62 against a most followed fair value estimate of $66.57, the gap in expectations is wide and worth understanding. Read the complete narrative. Read the complete narrative. Want to see what is behind that valuation gap? The narrative leans heavily on sustained revenue expansion, improving margins and a rich late stage pipeline feeding those future cash flows. Based on this narrative, Immunocore is modeled using a discount rate of 8.02% to arrive at a fair value of $66.57, almost double the last close. The thesis connects long term revenue growth, a shift toward positive margins and eventual earnings power to support that price level over time. Result: Fair Value of $66.57 (UNDERVALUED) Have a read of the narrative in full and understand what's behind the forecasts. However, the bullish story could be knocked off course if KIMMTRAK growth flattens before new programs contribute, or if higher R&D spend keeps net income under pressure. Find out about the key risks to this Immunocore Holdings narrative. With mixed signals across earnings, survival data and the share price, it may be helpful to review the full picture yourself, including the 3 key rewards and 1 important warning sign If Immunocore has caught your attention, do not stop here. Use these focused stock ideas to quickly spot opportunities that could fit your portfolio before others do. Target potential bargains by scanning 51 high quality undervalued stocks that pair quality fundamentals with attractive pricing. Prioritize resilience by reviewing 72 resilient stocks with low risk scores built around companies with lower risk profiles. Hunt for future leaders by checking the screener containing 23 high quality undiscovered gems that combine strong fundamentals with limited current attention. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include IMCR. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]