Kupando Announces First Patient Dosed in Phase 1 Clinical Study of Lead Candidate KUP101 in Advanced Solid Tumors

On August 6, 2026 Kupando, a pioneering biopharmaceutical company developing a TLR 4/7 agonist that stimulates innate immunity and induces trained immunity for use in oncology and infectious diseases, reported that the first patient has been successfully dosed in its Phase 1 clinical study of its lead drug candidate, KUP101, in patients with advanced solid tumors, specifically focusing on advanced skin tumors.

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This major milestone marks Kupando’s transition from a preclinical-stage researcher into a clinical-stage biopharmaceutical company, validating the shift of its innovative science from the laboratory to the bedside.

"Dosing our first patient is a defining inflection point in Kupando’s history," said Dr. Johanna Holldack, Founder and CEO of Kupando. "By leveraging the power of innate immune stimulation and the induction of trained immunity, KUP101 represents a fundamentally different way of approaching hard-to-treat cancers. Moving into the clinic is a testament to the dedication of our team, our clinical investigators in Germany, and the strong backing of our investor syndicate."

Following the successful dosing of the first patient, the safety committee has reviewed the initial administration and approved the ongoing enrolment of further patients across the activated clinical sites.

KUP101 is a first-in-class, differentiated dual TLR 4 and 7 agonist. Unlike conventional oncology treatments that target specific tumor mutations or individual pathways, KUP101 stimulates the innate immune system – the body’s universal defense – to activate immunocompetent cells in the microenvironment surrounding the cancer. Because it works via immune stimulation rather than targeting the cancer cells directly, KUP101 is designed to be a tissue-agnostic treatment capable of providing a broader and more durable immune response. Preclinical studies have also demonstrated synergistic and additive effects when combined with checkpoint inhibitors, offering renewed hope for patients who do not respond to or have developed resistance to existing immunotherapies.

The Phase 1 trial is being conducted at leading oncology centers in Germany, partnering with expert investigators and specialized clinical research organizations to ensure the highest standards of safety, tolerability, and data integrity.

Beyond oncology, Kupando is advancing its preclinical pipeline in infectious diseases – specifically targeting antimicrobial resistance (AMR) through pathogen-agnostic host-directed therapies.

(Press release, Kupando, AUG 6, 2026, View Source [SID1234669797])

Iovance Biotherapeutics Reports Record Second Quarter 2026 Revenue of ~$99M, Business Achievements, and Corporate Updates

On August 6, 2026 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported second quarter 2026 financial results, business achievements, and corporate updates.

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"Second-quarter revenue reached a record $99.3 million with gross margin of 56%, driven by continued U.S. Amtagvi demand," said Frederick Vogt, Ph.D., J.D., Interim President and Chief Executive Officer. "Based on our second-quarter performance and strong demand trends, we are reviewing our previously issued 2026 revenue guidance of $350 million to $370 million and will provide an update during the third quarter. Additionally, we continue to be excited by our clinical pipeline as lifileucel advances across other solid tumor indications including metastatic non-squamous non-small-cell lung cancer (NSCLC), the new registrational SARATOGA trial in undifferentiated pleomorphic sarcoma (UPS) and dedifferentiated liposarcoma (DDLPS), and metastatic serous endometrial cancer. Continued manufacturing and operating efficiencies support our sustainable growth, accelerate progress toward profitability, and advance our clinical pipeline with first-in-class, novel products in new solid tumor indications."

Second Quarter 2026 Financial Highlights

Record Revenue and Improving Margin Supported by Cost Discipline

· Total product revenue was ~$99 million, an increase of 66% from ~$60 million in 2Q25 and 39% from ~$71 million in 1Q26.
· U.S. Amtagvi revenue was ~$91 million, up 40% from 4Q25. Global Proleukin revenue was ~$9 million and is expected to grow during the remainder of 2026.
· Gross margin was 56%1, reflecting higher Amtagvi sales volume, continued cost optimization, and maturing internal manufacturing efficiencies.
· Research and Development (R&D) expenses decreased by ~6% compared to 1Q26, driven by continued operational efficiencies during the fourth straight quarter of improvements.

Full Year 2026 Outlook

Second Quarter Performance and Demand Growth

· Based on strong second-quarter sales and current demand trends, Iovance is reviewing its FY26 total revenue guidance of $350 million to $370 million. An update will be provided during the third quarter.
· Improvements in gross margin are expected to continue, excluding occasional one-time items.

Amtagvi Commercial Business

Significant U.S. Commercial Business Growth and Progress in Global Expansion

· Demand and awareness: Record Amtagvi demand, catalyzed by a new marketing campaign and an expanded sales team, is driving increased adoption across a growing ATC network and referrals toward earlier treatment. Unaided physician awareness of Amtagvi has nearly tripled during the last year.
· Authorized treatment center (ATC) network: The network has grown to more than 95 U.S., Canadian, and Australian ATCs, with at least 110 ATCs expected to be active by the end of 2026. Community ATCs now represent a third of the network and are expected to increase significantly over the next several quarters.
· Real-world experience: Multiple real-world studies by Iovance and ATCs using commercial Amtagvi continue to advance, supporting broader adoption of Amtagvi and earlier patient referrals and access. These studies highlight objective response rates (ORRs) of 50% or greater and address identification of tumor harvest sites, accelerated institutional workflows, and improved patient care.
· Manufacturing turnaround time: Amtagvi turnaround time is 31 days or less using the only scaled, centralized commercial manufacturing process approved by FDA for TIL therapy.
· Australia: The marketing authorization application (MAA) for Amtagvi in Australia was approved by the Therapeutic Goods Administration (TGA), marking the third approval of Amtagvi by global health authorities to date. A high incidence of advanced melanoma in Australia causes more than 1,500 annual deaths. Australian ATCs are currently progressing through the authorization process in parallel with discussions for national reimbursement.
· United Kingdom (UK): The MAA for Amtagvi in the UK was resubmitted in early July and is undergoing expedited review by the Medicines and Healthcare products Regulatory Agency (MHRA) for potential approval later in 2026. Advanced melanoma causes more than 2,500 deaths annually in the UK.
· Switzerland: Potential approval of the MAA in Switzerland is expected in 1H27, opening a second market opportunity in Europe with the potential for medical tourism. Switzerland’s domestic melanoma burden causes several hundred deaths annually.
· Other markets and indications: An MAA resubmission for Amtagvi in advanced melanoma to the European Medicines Agency is on track for 2027. Other regulatory submissions are planned in international markets with a high prevalence of advanced melanoma, NSCLC, and soft tissue sarcomas.

Clinical and Regulatory Pipeline Updates

Progress Across a Deep Pipeline of Registrational Programs

· IOV-LUN-202: Initial results in previously treated metastatic non-squamous NSCLC supported FDA FTD. Enrollment is nearly complete in the pivotal cohorts and program updates are expected in 4Q26. A supplemental Biologics License Application (sBLA) submission is planned in 2027. The U.S. market opportunity in metastatic non-squamous NSCLC is about seven times that of advanced melanoma.
· SARATOGA (IOV-SAR-201): The registrational trial in UPS and DDLPS is underway, driven by positive early data with an ORR by RECIST v1.1 of 50% in the first six evaluable patients. Based on the strength of this early data, FDA granted FTD for UPS and DDLPS. Results will be highlighted in an oral presentation (abstract #3725RO) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) meeting in Madrid, Spain, from October 23–27, 2026.

· TILVANCE-301: A Phase 3 randomized trial of lifileucel and pembrolizumab is enrolling patients with frontline advanced melanoma across a broad global footprint. The TILVANCE-301 trial includes an early interim analysis based on ORR for a potential sBLA for frontline advanced melanoma. The trial also serves as the confirmatory study for the accelerated approval of lifileucel in second-line advanced melanoma. Results supporting the combination of lifileucel and pembrolizumab as a potential best-in-class option for frontline advanced melanoma were accepted (abstract #2072O) for an oral presentation at the ESMO (Free ESMO Whitepaper) annual meeting.
· IOV-END-201: Positive initial data in previously treated metastatic serous endometrial cancer using a biomarker strategy based on histology were recently reported. A protocol amendment is being submitted and engagement with FDA is underway on an expedited approval pathway to focus on this population.

Next-Generation Pipeline Updates

First-in-Class Immuno-Oncology Technologies Target New Indications

· IOV-GM1-201: A Phase 1/2 trial investigating IOV-4001, a PD-1 inactivated TIL therapy, is enrolling patients with previously treated metastatic melanoma and NSCLC. IOV-4001 is engineered to resist inhibitory signals and enhance the ability of TIL therapies to fight and kill cancer in the tumor microenvironment (TME).
· IOV-GE1-201: A Phase 1/2 trial is underway using IOV-5001, a second-generation IL-12 tethered TIL therapy designed to remodel the suppressive TME and activate immunologically "cold tumors" to support TIL responses and boost response rates.2 Cohorts include metastatic colorectal cancer, triple-negative and estrogen receptor low breast cancers, and other solid tumors causing more than 100,000 annual U.S. deaths.3
· IOV-IL2-101: A Phase 1 safety cohort is advancing through multiple dose levels in the Phase 1/2 trial of IOV-3001, our second-generation modified IL-2 analog for the TIL treatment regimen. IOV-3001 selectively expands effector T cells while avoiding activation of regulatory T cells with the potential for a lower dose IL-2 regimen with reduced adverse events. IOV-3001 is expected to be superior to Proleukin as a component of future TIL regimens.
· Investigator-sponsored trials (ISTs): Iovance is advancing several lifileucel ISTs in new indications. Multiple patients have been treated for cutaneous squamous cell carcinoma (CSCC) and Merkel cell carcinoma (MCC) with initial data expected in 1H27. To date, early clinical activity has been reported. With no approved therapies after failure of checkpoint inhibitors, lifileucel could address a large CSCC and MCC market with several thousand annual deaths in the U.S.

Corporate Updates

· Iovance is deploying and advancing artificial intelligence (AI) tools to drive significant future cost efficiencies and new product pipeline insights.
· Iovance currently owns or licenses more than 400 granted or allowed U.S. and international patents and patent rights for Amtagvi and other TIL-related technologies and has filed more than 1,000 additional patent applications worldwide. This broad patent portfolio is expected to provide patent exclusivity through at least 2042 and beyond.
· As of June 30, 2026, Iovance’s cash position was ~$304 million4 and current cash is expected to fund operations into 2H28.

Webcast and Conference Call

Management will host a conference call and live audio webcast to discuss these results and provide a corporate update today at 8:30 a.m. ET. To listen to the live or archived audio webcast, please register at View Source The live and archived webcast can be accessed in the Investors section of the Company’s website, IR.Iovance.com, for one year.

1. Excludes depreciation and amortization

2. Zhang L, Rosenberg SA, et al., Clin Cancer Res 2015;21(10):2278–2288.

3. Surveillance, Epidemiology, and End Results Program Cancer Stat Facts (accessed April 2026).

4. Cash, cash equivalents, short-term investments, and restricted cash as of June 30, 2026.

(Press release, Iovance Biotherapeutics, AUG 6, 2026, View Source [SID1234669796])

Immunocore reports second quarter financial results and provides a business update

On August 6, 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, reported its financial results for the first half ended June 30, 2026, and provided a business update.

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"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.

KIMMTRAK

The 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 (Free AACR Whitepaper) 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 (Free ASCO Whitepaper) 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 diseases
The 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.

(Press release, Immunocore, AUG 6, 2026, View Source [SID1234669795])

HALOZYME REPORTS RECORD SECOND QUARTER 2026 RESULTS, BEATS ESTIMATES AND RAISES FULL YEAR 2026 FINANCIAL GUIDANCE

On August 6, 2026 Halozyme Therapeutics, Inc. (Nasdaq: HALO) ("Halozyme" or the "Company") reported its financial and operating results for the second quarter ended June 30, 2026, and provided an update on its recent corporate activities.

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"We delivered another quarter of strong performance, with multiple proof points demonstrating the attractive features of ENHANZE as a compounding platform engine: repeatability of success, scalability, diversification and durability of revenues," said Dr. Helen Torley, President and Chief Executive Officer. "Total revenue increased 48% year-over-year to $481 million, royalty revenue increased 50% to $308 million and adjusted EBITDA grew 46% to $329 million, reflecting the strength of our differentiated royalty business. Based on these record results, we are raising our full year 2026 financial guidance."

"Importantly, we are delivering on both our near-term and long-term growth objectives. The ENHANZE value proposition is attracting new partners and additional products from our current partners. We expanded our royalty revenue opportunity by signing five new ENHANZE and Hypercon collaborations through July, including agreements with Vertex, Oruka, GSK, Incyte and an undisclosed partner who is the first to license ENHANZE for a nucleic acid therapeutic. We have also demonstrated our commitment to returning significant capital to shareholders, repurchasing $333 million of shares in 2Q 2026, at an average price of $69.30. Overall, these results illustrate our continued ability to create multiple waves of revenue opportunities that will drive long-term shareholder value," concluded Dr. Torley.

Second Quarter Corporate Highlight:
•In May 2026, the Company announced a new share repurchase program to repurchase up to $1.0 billion of its outstanding common stock by December 31, 2028, with an expectation of buying back at least $400 million of shares in 2026. During the second quarter of 2026, the Company repurchased 4.8 million shares for $332.8 million at an average price of $69.30 per share under the May 2026 and February 2024 share repurchase programs. The February 2024 share repurchase program was completed in June 2026.

Recent Partner Highlights:
•In July 2026, Halozyme and Incyte entered into a global collaboration and license agreement to evaluate additional subcutaneous formulations of INCA033989, a first-in-class mutant calreticulin ("mutCALR")-targeted monoclonal antibody, in patients with mutCALR-expressing myeloproliferative neoplasms ("MPNs"), utilizing Halozyme’s proprietary ENHANZE drug delivery technology. Under the collaboration, Incyte also has the option to nominate up to two additional targets for use with ENHANZE. Under the terms of the agreement, Incyte agreed to make an upfront payment and potential future milestone payments and royalties on net sales of products developed with ENHANZE.
•In the third quarter of 2026, the ongoing ARGX-119 adimanebart program was expanded to include a Phase 1 SC bioavailability study with ENHANZE.

Second Quarter Partner Highlights:
•In May 2026, Halozyme and an undisclosed company entered into a global collaboration and license agreement that provides the company access to ENHANZE to develop a nucleic acid therapeutic.
•In May 2026, Janssen announced pivotal results from the Phase 1b/2 OrigAMI-4 study showing that subcutaneous amivantamab and hyaluronidase-lpuj delivered durable responses in patients with advanced head and neck squamous cell carcinoma previously treated with immunotherapy and chemotherapy and submitted a supplemental Biologics License Application ("sBLA") to the U.S. Food and Drug Administration ("FDA").
•In May 2026, Viatris initiated a Phase 1 study to evaluate the pharmacokinetics, pharmacodynamics, and tolerability of a single dose of selatogrel in Chinese adults with chronic coronary syndrome.
•In May 2026, argenx announced FDA approval of a sBLA for VYVGART Hytrulo with ENHANZE for the treatment of adult patients with generalized myasthenia gravis including all serotypes – anti-AChR-Ab positive, anti-MuSK-Ab positive, anti-LRP4-Ab positive, and triple seronegative.
•In May 2026, Halozyme and GSK plc ("GSK") entered into a global collaboration and license agreement for ENHANZE with multiple oncology targets, including the first potential application in antibody-drug conjugates. Under the terms of the agreement, GSK made an upfront payment and agreed to make potential future milestone payments and royalties on net sales of products developed with ENHANZE.
•In May 2026, Halozyme and Oruka Therapeutics, Inc. ("Oruka") entered into a global exclusive collaboration and license agreement for Halozyme’s Hypercon technology for use with ORKA-001, in development for psoriasis and related inflammatory diseases and one additional target. Under the terms of the agreement, Oruka made an upfront payment and agreed to make potential future milestone payments and mid-single digit royalties on net sales of products developed using the Hypercon technology.
•In May 2026, Takeda announced positive topline results from its pivotal Phase 2/3 trial of TAK-881 with ENHANZE in Primary Immunodeficiency Disease.
•In April 2026, Halozyme and Vertex Pharmaceuticals Incorporated ("Vertex") entered into a global exclusive collaboration and license agreement that provides Vertex access to Halozyme’s Hypercon technology for use in up to three targets. Under the terms of the agreement, Vertex made a $15 million upfront payment and agreed to make potential future milestone payments and royalties on net sales of products developed using the Hypercon technology.

Second Quarter 2026 Financial Highlights:
•Total revenue was $481.0 million, compared to $325.7 million in the second quarter of 2025. The 48% year-over-year increase was primarily driven by royalty revenue growth and an increase in product sales. Revenue included $307.7 million in royalties, an increase of 50% compared to $205.6 million in the second quarter of 2025, primarily driven by continued sales uptake of ENHANZE partner products that have launched since 2020, predominantly by VYVGART Hytrulo by argenx and DARZALEX SC Janssen in all geographies and contributions from other recently launched products.
•Cost of sales was $79.2 million, compared to $46.4 million in the second quarter of 2025. The increase in cost of sales was primarily due to an increase in bulk rHuPH20 sales.
•Amortization of intangibles expense was $29.5 million, compared to $17.8 million in the second quarter of 2025. The increase in amortization of intangibles expense was due to the acquisition of Elektrofi, Inc. ("Elektrofi") in November 2025.
•Research and development expense was $27.7 million, compared to $17.5 million in the second quarter of 2025. The increase was primarily due to the acquisition of Elektrofi and Surf Bio, Inc. ("Surf Bio") in the fourth quarter of 2025.
•Selling, general and administrative expense was $57.0 million, compared to $41.6 million in the second quarter of 2025. The increase was primarily due to an increase in consulting and professional service fees, including litigation costs incurred in connection with patent infringement litigation, the acquisition of Elektrofi and Surf Bio, and an increase in compensation expense.
•Operating income was $287.7 million, compared to $202.4 million in the second quarter of 2025.
•Net income was $229.9 million, compared to $165.2 million in the second quarter of 2025.
•EBITDA was $321.9 million, compared to $222.9 million in the second quarter of 2025. Adjusted EBITDA was $328.8 million, compared to $225.5 million in the second quarter of 2025.1
•GAAP diluted earnings per share was $1.90, compared to $1.33 in the second quarter of 2025. Non-GAAP diluted earnings per share was $2.28, compared to $1.54 in the second quarter of 2025.1
•Cash, cash equivalents, restricted cash and marketable securities were $231.9 million on June 30, 2026, compared to $145.4 million on December 31, 2025. The increase was primarily driven by cash generated from operations.

Financial Outlook for 2026
The Company is raising its 2026 financial guidance ranges, which were last provided on May 11, 2026.
For the full year 2026, the Company expects:
•Total revenue of $1.835 billion to $1.910 billion, representing growth of 31% to 37% over 2025 total revenue, primarily driven by increases in royalty revenue and product sales from API.
•Revenue from royalties of $1.220 billion to $1.245 billion, representing growth of 41% to 43% over 2025.
•Adjusted EBITDA of $1.225 billion to $1.280 billion, representing growth of 86% to 95% over 2025, including new Hypercon and Surf Bio investments of approximately $60 million.
•Non-GAAP diluted earnings per share of $8.65 to $9.00, representing growth of 108% to 117% over 2025. The Company’s earnings per share guidance includes new Hypercon and Surf

Bio investments of approximately $60 million and does not consider the impact of potential future share repurchases.
Table 1. 2026 Financial Guidance
Previous Guidance Range New Guidance Range
Total Revenue $1.710 to $1.810 billion $1.835 to $1.910 billion
Royalty Revenue $1.130 to $1.170 billion $1.220 to $1.245 billion
Adjusted EBITDA1
$1.125 to $1.205 billion $1.225 to $1.280 billion
Non-GAAP Diluted EPS1
$7.75 to $8.25 $8.65 to $9.00

1 EBITDA, Adjusted EBITDA and Non-GAAP Diluted EPS are Non-GAAP financial measures. See "Note Regarding Use of Non-GAAP Financial Measures" below for an explanation of these measures. Reconciliations between GAAP reported and Non-GAAP financial information for actual results are provided at the end of this earnings release.

Webcast and Conference Call
Halozyme will host its Quarterly Update Conference Call for the second quarter ended June 30, 2026 today, Thursday, August 6, 2026, at 1:30 p.m. PT/4:30 p.m. ET. The conference call may be accessed live with pre-registration via link: View Source The call will also be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit Halozyme.com.

(Press release, Halozyme, AUG 6, 2026, View Source [SID1234669794])

Genmab Announces Financial Results for the First Half of 2026

On August 6, 2026 Genmab reported financial results for the first half of 2026.

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Highlights

•Genmab announced positive Phase 3 results for epcoritamab plus lenalidomide in patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), demonstrating statistically significant improvement in progression-free survival
•Genmab revenue increased 25% compared to the first six months of 2025, to $2,051 million
•Genmab 2026 financial guidance updated

"The second quarter of 2026 delivered clinical progress for our late-stage portfolio. Epcoritamab continued to demonstrate its potential as a core therapy across the spectrum of B-cell malignancies, with strong data across multiple treatment settings and patient populations. At the same time, new data further support the development of Rina-S (rinatabart sesutecan) in combination in advanced ovarian cancer. Together, these results reflect our continued commitment to delivering meaningful advances for patients," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Half of 2026
•Revenue was $2,051 million for the first six months of 2026 compared to $1,640 million for the first six months of 2025. The increase of $411 million, or 25%, was primarily driven by higher DARZALEX and Kesimpta royalties and higher EPKINLY net product sales.
•Royalty revenue was $1,708 million in the first six months of 2026 compared to $1,378 million in the first six months of 2025, an increase of $330 million, or 24%. The increase in royalties was driven by higher net sales of DARZALEX and Kesimpta.
•Net sales of DARZALEX by J&J were $8,171 million in the first six months of 2026 compared to $6,776 million in the first six months of 2025, an increase of $1,395 million or 21%.
•Global net sales of EPKINLY/TEPKINLY were $312 million in the first six months of 2026 compared to $211 million in the first six months of 2025, an increase of $101 million or 48%.
•Cost of product sales were $149 million for the first six months of 2026 compared to $99 million for the first six months of 2025. The increase of $50 million, or 51%, was primarily driven by the profit-sharing amounts payable to AbbVie related to EPKINLY sales.
•Adjusted operating expenses, excluding Acquisition and integration related charges, were $1,270 million for the first six months of 2026 compared to $993 million for the first six months of 2025. The increase of $277 million, or 28%, was primarily driven by investment in our product pipeline, including the advancement of Rina-S and petosemtamab, and our global commercialization capabilities in preparation for their anticipated launches.
•Acquisition and integration related charges related to the integration of Merus were $77 million in the first six months of 2026.
•Amortization of acquired intangible assets was $24 million for the first six months of 2026 compared to $6 million for the first six months of 2025. The increase of $18 million, was primarily driven by the amortization of the Merus technology platform.
•Operating profit was $555 million in the first six months of 2026 compared to $548 million in the first six months of 2025. Adjusted operating profit, which excludes Acquisition and integration related charges and Amortization of acquired intangible assets, was $656 million in the first six months of 2026 compared to $554 million in the first six months of 2025.

Outlook
Genmab is updating its revenue, adjusted operating expenses and adjusted operating profit guidance for 2026. The improved guidance is driven by higher total royalty revenues from DARZALEX and net sales of EPKINLY.

2026 FULL YEAR OUTLOOK
(USD million) Revised Guidance² Revised
Mid-Point² Previous Guidance³ Previous Mid-Point³
Revenue 4,325 – 4,525 4,425 4,065 – 4,395 4,230
Royalties 3,625 – 3,750 3,687 3,440 – 3,685 3,563
Net product sales/Collaboration revenue¹ 595 – 640 618 490 – 555 522
Milestones/Reimbursement revenue 105 – 135 120 135 – 155 145
Gross profit 4,015 – 4,195 4,105 3,810 – 4,110 3,960
Adjusted operating expenses (2,810) – (2,950) (2,880) (2,710) – (2,910) (2,810)
Adjusted operating profit 1,065 – 1,385 1,225 900 – 1,400 1,150

1 Net product sales/Collaboration revenue consists of EPKINLY net product sales in the U.S. and Japan, and Tivdak ex-U.S. net product sales plus Genmab’s share of U.S. gross profits.
2 Adjusted operating expenses and operating profit exclude 2026 charges related to: 1) acquisition and integration-related charges of $90 million and 2) amortization of intangible assets acquired through acquisitions of $47 million.
3 Adjusted operating expenses and operating profit exclude 2026 charges related to: 1) acquisition and integration-related charges of $65 million and 2) amortization of intangible assets acquired through acquisitions of $45 million.

Non-IFRS Financial Measures
Our Adjusted operating expenses and Adjusted operating profit excludes acquisition and integration related charges and amortization of acquired intangible assets. These charges were recognized in prior periods and will likely reoccur in future periods. These items are excluded from operating expenses and operating profit because the Company believes they neither relate to the ordinary course of the Company’s business nor reflect the Company’s underlying business performance.

Non-IFRS information is intended to portray the results of our baseline performance, supplement or enhance management’s, analysts’ and investors’ overall understanding of our underlying financial performance and facilitate comparisons among current, past and future periods. This information is not intended to be considered in isolation or as a substitute for the related financial measures prepared in accordance with IFRS and may not be the same as or comparable to similarly titled measures presented by other companies due to possible differences in method and in the items being adjusted. We encourage investors to review our financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.

Conference Call
Genmab will hold a conference call to discuss the results for the first six months of 2026 today, Thursday, August 6, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call please use the below registration link. Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN: View Source A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investor-relations.

(Press release, Genmab, AUG 6, 2026, View Source [SID1234669793])