On August 6, 2026 Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets, while developing a diverse pipeline of novel, multifunctional biotherapeutics, reported financial results for the second quarter ended June 30, 2026 and provided a summary of recent business highlights. In light of the previously announced proposed acquisition of Theravance Biopharma, the Company has elected not to host a second quarter earnings conference call after release of its financial results.

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"The first half of 2026 has been a transformative period for Zymeworks, demonstrating the continued evolution of our business into a diversified, revenue-generating biotechnology business. While scientific innovation remains our foundation, we believe long-term value is created not only through discovering new medicines, but also through disciplined capital allocation, creative business development and thoughtful partnership structures that maximize the impact of that innovation for patients and shareholders," said Kenneth Galbraith, Chair and Chief Executive Officer of Zymeworks.

"The second half of 2026 has the potential to continue creating meaningful value for both patients and shareholders. Subject to regulatory approval and customary closing conditions, the August U.S. PDUFA target action date for zanidatamab and the planned closing of the Theravance Biopharma acquisition, respectively, would immediately strengthen our revenue base and cash flow outlook. This includes a $250 million approval milestone for zanidatamab in the U.S. with up to $190 million in additional potential global regulatory milestones. These diverse royalty and milestone cash flows improve our ability to sustain long-term investment in our wholly-owned R&D pipeline, pursue additional strategic acquisitions and partnerships, and continue returning capital to shareholders through our share repurchase program. We believe this disciplined approach to compounding capital and innovation is what will differentiate Zymeworks over the long term."

Business Highlights
Positioning Zymeworks for Multiple Value-Creating Catalysts in 2H 2026

Advancing Partnerships Toward Key Regulatory and Commercial Inflection Points

Zanidatamab

The top-line results from the second interim overall survival analysis for the HERIZON-GEA-01 trial doublet regimen are expected in the third quarter of 2026.
The FDA granted Breakthrough Therapy Designation (BTD) for zanidatamab (Ziihera), for the treatment of adults with previously treated, locally advanced, unresectable, or metastatic HER2-positive colorectal cancer.
The EmpowHER-303 trial is expected to complete patient enrollment in mid-2027 with top-line data expected by the end of 2027 or early 2028.
Results from Phase 3 HERIZON-GEA-01 published in The New England Journal of Medicine; Additional subgroup analyses presented in an oral presentation at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting showing improved clinical outcomes with zanidatamab-containing combinations regardless of PD-L1 expression, including in PD-L1-negative patients.
August 25, 2026 U.S. PDUFA target action date for zanidatamab for the treatment of patients with first-line (1L) HER2-positive (HER2+) locally advanced or metastatic gastroesophageal adenocarcinoma (GEA).
Potential $250 million milestone upon approval in the U.S., the first of up to a total of $440 million potential global regulatory milestones for zanidatamab in 1L HER2+ GEA. Zymeworks will continue to receive royalties on Ziihera sales, with royalty revenues expected to increase following U.S. and global regulatory approvals for GEA.
Our royalty revenue from Jazz Pharmaceuticals (Jazz) and BeOne Medicines was $1.8 million in the three months ended June 30, 2026, driven primarily by net product sales of Ziihera by Jazz in the United States.

Pasritamig

Johnson and Johnson Innovative Medicine (J&J) expect to present Phase 1b clinical data for pasritamig, a first-in-class bispecific antibody against KLK2, in combination with JNJ-9401 in patients with advanced prostate cancer who have progressed after multiple lines of therapy, during the second half of 2026.
J&J increased the planned enrollment for its Phase 3 trial of pasritamig (JNJ-78278343) in combination with best supportive care in patients with late-line metastatic castration-resistant prostate cancer (mCRPC), from approximately 663 to 1,203 participants. The study is actively recruiting across 172 sites globally and is evaluating overall survival versus placebo, with median overall survival as the primary endpoint. The anticipated primary completion date is now estimated as December 2027, compared with the previously estimated May 2028 date (NCT07164443).
Leveraging Partnerships and External Innovation

The Company is advancing strategic initiatives to maximize the value of its proprietary Pan-RAS antibody-drug conjugate (ADC) platform, including evaluating the formation of a separate, dedicated entity with third-party capital participation. The Company expects to use third-party capital to advance multiple product candidates from the platform into clinical studies while retaining an equity interest and future economic participation, including potential royalties, subject to completion of a transaction.
The Company has engaged MTS Healthcare to evaluate strategic partnering opportunities to fund further development for ZW191 with the objective of maximizing long-term value.
The Company continues its evaluation of additional business development opportunities consistent with its capital allocation strategy.
Expanding Revenue Diversification

Proposed acquisition of Theravance Biopharma expected to be accretive to earnings and generate positive cash flow upon closing in 2H 2026.
YUPELRI U.S. profit share and ex-U.S. royalties expected to generate ~$60 million annualized cash flow at current run-rates, with continued expected growth.
Proposed acquisition to add diversified assets beyond YUPELRI, including additional royalty interests, milestone payments, an early-stage I&I portfolio, and $2.5 billion in Irish tax attributes, further strengthening both potential near-term cash flow generation and long-term development optionality.
Transaction financed primarily by $350 million non-recourse note secured solely by U.S. YUPELRI profit share from OMERS Life Sciences, and Theravance Biopharma’s expected net cash balance of $360 million at closing, with Zymeworks contributing the remainder of the purchase price in cash at closing. Zymeworks expects to receive $100 million in TRELEGY ELLIPTA milestones in Q1 2027, assuming milestone conditions are met, in 2026, offsetting cash outlay.
The anticipated closing of the acquisition is expected to support Zymeworks’ transition to a diversified, revenue-generating business. Consistent with this evolution, the Company no longer intends to provide cash runway guidance, and expects to increasingly focus on providing guidance on operating performance and long-term growth.
Advancing a Differentiated ADC Pipeline

In June 2026, we presented new clinical data from the dose-escalation portion of the ongoing Phase 1 study evaluating ZW191, a folate receptor alpha-targeting antibody-drug conjugate, at the European Society for Medical Oncology Gynaecological Cancers Congress 2026. Among response-evaluable platinum-resistant ovarian cancer patients, ZW191 demonstrated a cORR of 78.6% in patients with FRα-positive tumors and 47.4% in patients with FRα-negative tumors across all dose levels. These findings demonstrate meaningful anti-tumor activity across both FRα-positive and FRα-negative tumors as well as in the overall population.
We continue to recruit patients in an ongoing Phase 1b study of ZW251, a GPC3-targeting antibody-drug conjugate, for the treatment of patients with hepatocellular carcinoma, squamous non-small cell lung cancer and germ cell tumors.
Maintaining Financial Flexibility

Cash Resources: Zymeworks reported $322.5 million in cash, cash equivalents and marketable securities as of June 30, 2026

Share Repurchase Program: In May 2026, the Board of Directors authorized a 2026 share repurchase program under which the Company may repurchase up to $125.0 million of its outstanding common stock, par value $0.00001 per share. As of August 4, 2026, the Company has utilized approximately $49.4 million of this current approved repurchase program to acquire 1,971,454 shares at an average price of $25.04 per share (exclusive of commission expense and estimated excise tax).

Since initiating its share repurchase program in August 2024, the Company has cumulatively utilized $213.6 million to reacquire 10,571,316 shares at an average price of $20.21 per share (exclusive of commission expense and estimated excise tax). As of August 4, 2026, the Company had approximately 71.0 million common shares outstanding.

Operating Expense Discipline: The Company expects significant near-term milestones, including the anticipated closing of the Theravance Biopharma acquisition and the upcoming August 25, 2026 PDUFA date for zanidatamab in GEA, each of which has the potential to immediately expand the Company’s revenue and cash flow profile, subject to customary closing conditions and regulatory approval, respectively. The Company continues to expect disciplined investment across research and development and general and administrative activities through the anticipated closing of the Theravance Biopharma acquisition. The Company’s previously communicated operating expense framework was established prior to entering into the definitive acquisition agreement, and therefore does not reflect the expected operating profile of the combined organization. Subject to the successful completion of the transaction, the Company expects to provide an updated financial outlook following closing that reflects the combined business.

Financial Results for the Quarter Ended June 30, 2026

The key financial highlights for our 2026 second quarter results are as follows:

Revenue – Total revenue was $4.6 million in 2Q-2026, compared to $48.7 million for the same period in 2025. The decrease was driven mainly by absence of significant non-recurring collaboration revenue recognized in 2026, as well as continued declines in development support and drug supply revenue from Jazz. Revenue in the current‑year period reflects ongoing collaboration activity and increased royalty revenue, which is expected to grow over time as commercial sales of Ziihera increase.

Research and Development (R&D) Expenses – R&D expenses were $27.4 million in 2Q-2026, compared to $34.4 million for the same period in 2025, primarily reflecting reduced spending on later‑stage and discontinued programs, as well as an overall decrease in spending for earlier‑stage programs and research platforms. R&D expenses in 2Q-2026 were 20% lower than in 2Q-2025, consistent with our planned reduction in R&D expenses in 2026.

General and Administrative (G&A) Expenses – G&A expenses were $19.3 million in 2Q-2026, compared to $15.0 million for the same period in 2025. The increase was primarily driven by higher non-cash stock-based compensation expense. This increase was partially offset by decrease in software amortization and software subscription expenses.

Other Income, net – Net other expense was $3.1 million in 2Q-2026, compared to net other income of $2.8 million for the same period in 2025. The change was driven primarily by $6.6 million of interest expense related to the royalty-backed note financing arrangement with Royalty Pharma executed in March 2026.

Net Loss – Net loss was $45.0 million in 2Q-2026, compared to a net income of $2.3 million for the same period in 2025. The change in 2026 was primarily due to a decrease in revenue, driven by the non-recurring clinical milestones earned in 2Q-2025 and interest expense related to the royalty-backed note financing arrangement with Royalty Pharma. This was partially offset by decrease in total operating expenses.

Liquidity – As of June 30, 2026, we had $322.5 million of cash resources consisting of cash, cash equivalents and marketable securities, comprised of $179.4 million in cash and cash equivalents and $143.1 million in marketable securities. In light of the Company’s expected transition to a revenue-generating business supported by multiple anticipated recurring cash flow streams, the Company no longer intends to provide cash runway guidance. Going forward, the Company expects to focus its financial outlook on metrics that more appropriately reflect the operating performance and growth of the business.

(Press release, Zymeworks, AUG 6, 2026, View Source [SID1234669841])

On August 6, 2026 Circio Holding ASA (OSE: CRNA), a biotechnology company developing novel circular RNA expression technology for gene and cell therapy, reported that it has been selected for an oral presentation at the European Society of Gene and Cell Therapy annual meeting in Hamburg, Germany, 27-30 October 2026.

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The ESGCT Annual Meeting is the leading gene and cell therapy conference in Europe and the second largest globally, recognized as one of the most prestigious scientific meetings in the field. The meeting is widely attended by pharma industry professionals, academics, patient advocacy organizations and life science media. Only a small number of submitted abstracts are selected for oral presentation, underscoring the scientific quality and relevance of the work presented.

"ESGCT is one of the most important international meetings in the gene and cell therapy field, and it is very important for Circio that the organizing committee has selected one of Circio´s abstracts for an oral presentation," said Dr. Thomas B Hansen, CTO of Circio. "Presenting our circVec platform at ESGCT provides an excellent opportunity to showcase how our proprietary DNA vector technology has the potential to significantly enhance next-generation gene and cell therapies to a highly relevant audience of life science and industry leaders. This meeting also provides an important forum to engage with existing and prospective collaborators and partners as we continue to advance our R&D programs and expand commercial opportunities."

Circio has submitted three abstracts for ESGCT 2026, of which one has been selected for oral presentation and two for poster presentation. Further information about the Circio presentations and the full abstract texts will be released on the general abstract publication date, 27 October 2026.

Presentation title: circVec: A DNA Vector Platform Harnessing Intracellular Circular RNA Biogenesis for Next-Generation T Cell Therapies

Session: Non-viral vectors/nanotechnology and RNA therapeutics I

Time & location: Wednesday 28 October at 10:00am – Hamburg, Germany

(Press release, Circio, AUG 6, 2026, View Source [SID1234669740])

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])

On August 6, 2026 Replimune Group, Inc. (NASDAQ: REPL), a commercial stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for TUDRIQEVTM (vusolimogene oderparepvec-wtpg), previously referred to as RP1, in combination with nivolumab for the treatment of adults with unresectable advanced cutaneous melanoma who experienced disease progression on an anti-PD-1 antibody-based regimen.This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent on verification of clinical benefit in a confirmatory trial(s).

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The IGNYTE trial enrolled 140 patients with 91 patients with at least one non-injected lesion included in the efficacy-evaluable population. In this population, TUDRIQEV plus nivolumab achieved an objective response rate (ORR) of 24.2%, with a median duration of response of 14.1 months. Treatment was well tolerated with mostly mild-to-moderate adverse events. The patient population included patients with Stage 4 disease (80%), prior anti-PD-1 adjuvant treatment (13%), PD-L1 negative status (54%), lung (45%) and liver lesions (24%). The IGNYTE study data were published in the Journal of Clinical Oncology and are available here.

"This is a transformative moment for Replimune, marking years of pioneering research to bring TUDRIQEV to patients desperately in need of new treatment options for advanced melanoma," said Sushil Patel, Ph.D., CEO of Replimune. "We are deeply grateful to the melanoma community, including patients and investigators who participated in the clinical trial, for their tremendous support of this approval. We also would like to thank the FDA for recognizing the urgency to get this therapy to patients. Replimune is now focused on critical activities to deliver TUDRIQEV to as many patients as possible."

There are limited treatment options for advanced melanoma, and more than half of patients experience progression within six months of treatment on immune checkpoint inhibitors like anti-PD-1 therapy. These patients face a poor prognosis, with a median overall survival of less than one year following progression.

"Advanced melanoma patients have few options after anti-PD-1 therapy and face high morbidity and poor survival outcomes," said Michael K. Wong, MD, PhD, primary investigator of the IGNYTE study and Former Physician in Chief and Professor of Oncology at Roswell Park Comprehensive Cancer Center in Buffalo, NY. "With the approval of TUDRIQEV, we have a potent oncolytic immunotherapy that can be used in a broad population, including BRAF-naïve or pretreated, and adjuvant relapsed patients. Importantly, the therapy in combination with nivolumab drives immune activation with a favorable risk-benefit profile and can be injected into superficial and visceral lesions."

"The approval of RP1 in combination with nivolumab is a meaningful step forward for patients with advanced melanoma who have failed to benefit from immunotherapy," said Sam Guild, President of AIM at Melanoma. "Every year, more than 8,500 people die of melanoma in the U.S., and new treatment options are urgently needed."

TUDRIQEV combined with nivolumab was well-tolerated. The most common (incidence ≥ 10%) adverse reactions in patients treated with TUDRIQEV combined with nivolumab were nausea, diarrhea, vomiting, constipation, decreased appetite, abdominal pain, fatigue, pyrexia, chills, injection site reaction, influenza like illness, infections, musculoskeletal pain, arthralgia, headache, dizziness, cough, dyspnea, rash, pruritic and hemorrhage.1 Most treatment-related adverse reactions were grade 1 and 2 and transient.1 There were no grade 4 or 5 common adverse events. See additional Important Safety Information below.

TUDRIQEV is administered via direct intratumor injection into superficial and deep and/or visceral lesions1. For deep/visceral tumors, administration is guided by imaging technology.1 The recommended dose of TUDRIQEV is based on tumor size.1

To verify the clinical benefit of TUDRIQEV, a confirmatory Phase 3 trial, IGNYTE-3, is ongoing and assessing TUDRIQEV in combination with nivolumab (NCT06264180). For additional information about the trial, please visit View Source

Replimune is committed to helping patients in the U.S. with advanced melanoma gain access to treatment with TUDRIQEV. Eligible patients who are prescribed TUDRIQEV will have access to ReplimuneConnect Plus, a comprehensive program offering information on access, reimbursement and financial support.

Webcast Details

Replimune will host a webcast featuring members from the management team to discuss today’s developments at 4:30 p.m. ET on Thursday, August 6, 2026.

Listeners can register for the webcast via this link. Analysts wishing to participate in the question and answer session should use this link. A replay of the webcast will be available via the company’s investor website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.

About Melanoma
Melanoma is the fifth most common cancer, with approximately 105,000 new cases estimated in the U.S. in 2025, and the most lethal form of skin cancer, accounting for nearly 8,500 deaths annually. Standard of care therapy includes treatment with immune checkpoint blockade, to which approximately half of patients will not respond or will progress after treatment. Melanoma is considered advanced when the cancer spreads beyond the primary tumor to other parts of the body.

About IGNYTE
IGNYTE (NCT03767348) is an open-label, multicenter Phase 1/2 study evaluating the safety and efficacy of vusolimogene oderparepvec as monotherapy or in combination with nivolumab in adult patients with advanced solid tumors, including a registrational cohort of patients with advanced melanoma with confirmed progression on an anti-PD-1 containing regimen treated with vusolimogene oderparepvec plus nivolumab.

The anti-PD-1 failed melanoma registrational cohort included 140 patients who received vusolimogene oderparepvec plus nivolumab after confirmed progression while being treated for at least eight weeks with anti-PD-1 based therapy, with or without anti-CTLA-4. Of the 140 patients, 91 patients with at least one noninjected lesion were included in the efficacy-evaluable population.

About TUDRIQEVTM (vusolimogene oderparepvec-wtpg)
TUDRIQEV (vusolimogene oderparepvec-wtpg) is a genetically modified herpes simplex virus, type 1 (HSV-1) oncolytic viral therapy that encodes a fusogenic glycoprotein derived from gibbon ape leukemia virus with the R sequence deleted (GALV-GP-R–) and human granulocyte macrophage colony-stimulating factor (GM-CSF). The genes encoding the HSV-1 neurovirulence factor ICP34.5 and the transporter associated with antigen presentation inhibitor ICP47 are deleted from TUDRIQEV. TUDRIQEV preferentially replicates within the tumor leading to tumor lysis, release of tumor and viral antigens, proinflammatory molecules, and infiltration of T cells. The GALV-GP-R– expressed by TUDRIQEV increases direct tumor killing and the GM-CSF expressed by TUDRIQEV is intended to activate and mature dendritic cells and monocytes. In the anti-PD-1 resistant setting, TUDRIQEV and nivolumab in combination may promote anti-tumor immune response. To learn more, visit tudriqev.com.

INDICATION

TUDRIQEV (vusolimogene oderparepvec-wtpg) is indicated in combination with nivolumab for the treatment of adult patients with unresectable advanced cutaneous melanoma who experienced disease progression with a programmed death receptor-1 (PD-1)-blocking antibody-based regimen.

This indication is approved under accelerated approval based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION
Warnings and Precautions Accidental Exposure to TUDRIQEV: Healthcare providers, caregivers, close contacts, pregnant women, newborns, and patients should avoid direct contact with injected tumors, dressings, or bodily fluids of patients. Should accidental exposure occur, clean the affected area. Herpetic Infection or Reactivation: Assess and treat suspected herpetic lesions as clinically warranted. Visceral Injury: Monitor patients for signs and symptoms of visceral injury during and after TUDRIQEV administration and manage accordingly.

Adverse Reactions
Serious adverse reactions occurred in 35% of 140 patients who received TUDRIQEV in combination with nivolumab including 2 patients each with arthralgia, hypophysitis, immune-mediated enterocolitis, and pyrexia. Adverse reactions leading to permanent TUDRIQEV discontinuation occurred in 2.9% of 140 patients and were 1 each of amylase increased, lipase increased, myocarditis, and pneumonitis.

Most common non-laboratory adverse reactions (incidence ˃ 10%) are fatigue, pyrexia, chills, musculoskeletal pain, nausea, diarrhea/colitis, injection site reaction, headache, cough, influenza like illness, vomiting, pruritus, arthralgia, asthenia, constipation, decreased appetite, dizziness, skin/superficial infection, and dyspnea.

Drug interactions:
Antivirals: delay TUDRIQEV administration for 72 hours.

Special Populations
Females and Males of Reproductive Potential: Advise females of reproductive potential, and males with a female partner of reproductive potential to use effective contraception during TUDRIQEV treatment and for 90 days after the last dose.

Please report any adverse event or product quality complaint related to a Replimune product by calling 1-877-375-0095. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here for full Prescribing Information, including Patient Information.

(Press release, Replimune, AUG 6, 2026, View Source [SID1234669842])

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])