On August 6, 2026 Lyell Immunopharma, Inc. (Nasdaq: LYEL), a late-stage clinical company advancing a pipeline of next-generation chimeric antigen receptor (CAR) T-cell therapies for patients with cancer, reported financial results and business highlights for the second quarter ended June 30, 2026.

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Second Quarter Updates and Recent Business Highlights

Rondecabtagene Autoleucel (Ronde-cel): A next-generation dual-targeting CD19/CD20 CAR T-cell product candidate designed to increase complete response rates and prolong the duration of response as compared to approved CD19‑targeted CAR T-cell therapies for the treatment of large B-cell lymphoma (LBCL)

Ronde-cel is an autologous CAR T-cell product candidate under evaluation in two pivotal trials in patients with relapsed/refractory (R/R) LBCL in the third- or later-line (3L+) setting (PiNACLE) and the second-line (2L) setting (PiNACLE‑H2H). Ronde-cel targets B cells that express either CD19 or CD20 with a true ‘OR’ logic gate to achieve full potency at either target and is manufactured with a process that enriches for CD62L-positive cells to generate more naïve and central memory CAR T cells with enhanced stemlike features and antitumor activity. The U.S. Food and Drug Administration (FDA) has granted ronde-cel Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for the treatment of adults with R/R diffuse large B-cell lymphoma (DLBCL) in the 3L+ setting and also RMAT designation for the treatment of large B-cell lymphoma (LBCL) in the 2L setting. The FDA has also granted ronde‑cel Orphan Drug Designation for the treatment of DLBCL/HGBCL with MYC and BCL2 rearrangements.
•In June 2026, Lyell presented updated safety data and translational insights for ronde-cel in two presentations at the European Hematology Association (EHA) (Free EHA Whitepaper) 2026 Congress in Stockholm, Sweden.

◦Safety data from more than 100 patients with R/R LBCL treated with ronde-cel (65 in the 3L+ setting and 43 in the 2L setting) were presented. There were no Grade ≥ 3 CRS events and low rates of Grade ≥ 3 ICANS reported in the Phase 1/2 trial as of the data cutoff date of May 5, 2026, supporting the potential for outpatient administration. The manufacturing success rate was 97%.

◦Translational analyses were presented providing a biological basis for ronde-cel’s durable responses, including enhanced memory potential of cytotoxic effector cells from CD62L+ enrichment and CD19/CD20 dual-targeting to overcome low antigen expression.

•The PiNACLE pivotal single-arm trial, a seamless expansion of the 3L+ cohort in the Phase 1/2 multi‑cohort trial, is ongoing. Additional data from this trial are expected in the second half of 2026, and pivotal data are expected in mid-2027 with submission of a Biologics License Application (BLA) to the FDA expected to follow in the second half of 2027. The primary endpoint of the trial is overall response rate, including an evaluation of duration of response.
•PiNACLE-H2H, the first-of-its-kind Phase 3 randomized controlled trial evaluating ronde-cel versus investigator’s choice of axicabtagene ciloleucel or lisocabtagene maraleucel in patients with R/R LBCL in the 2L setting continues to enroll patients. A progress update for this trial is expected in the second half of 2026. The trial’s primary endpoint is event-free survival.
LYL273: A next-generation guanylyl cyclase C (GCC)-targeted CAR T-cell product candidate for the treatment of relapsed/refractory metastatic colorectal cancer (mCRC) and other GCC-expressing cancers
LYL273 is a GCC-targeted CAR T-cell product candidate enhanced with CD19 CAR expression and controlled cytokine release, designed to improve CAR T-cell expansion, immune cell infiltration and cancer cell killing in the hostile solid tumor microenvironment. In November 2025, Lyell acquired global rights (excluding mainland China, Hong Kong, Macau and Taiwan) to LYL273, which has shown promising dose-dependent clinical activity in patients with advanced R/R mCRC in a Phase 1 trial conducted in the U.S. following proof of concept in 15 patients in China. The FDA granted LYL273 Fast Track designation for the treatment of mCRC.

•In June 2026, Lyell reported updated safety data from patients with 3L+ R/R mCRC in the ongoing U.S. Phase 1 trial, including 19 patients, of which 10 were treated with gastrointestinal (GI) prophylaxis and a new safety management protocol and 9 were treated without GI prophylaxis across Dose Levels 1 and 2 (1 and 2 x 106 CAR+ cells/kg, respectively) as of the data cutoff date of May 5, 2026. The GI prophylaxis regimen included treatment with infliximab, vedolizumab and budesonide prior to the development of symptoms.

◦The rate of Grade ≥ 2 diarrhea or colitis was reduced from 55% to 10%, and there were no reported cases of Grade ≥ 3 diarrhea or colitis in patients treated with GI prophylaxis.
◦No patients treated with GI prophylaxis experienced Grade ≥ 3 CRS or ICANS.
◦GCC CAR T-cell expansion kinetics were similar in patients treated with and without GI prophylaxis.
◦Dose escalation continues, and the maximum tolerated dose has not been determined.

•Based on the new safety data, Lyell amended the ongoing U.S. Phase 1 trial to a Phase 1/2 design, enabling seamless expansion into a potential pivotal single-arm Phase 2 trial once the recommended Phase 2 dose is determined and subject to discussions with the FDA. The amendment adds new cohorts, including a 2L cohort and a cohort evaluating a combination strategy with radiotherapy.

•Additional U.S. Phase 1 clinical data in patients with R/R mCRC in the 3L+ setting and an End-of-Phase 1 meeting with the FDA are expected in the second half of 2026.

Second Quarter 2026 Financial Results
Lyell reported a net loss of $44.8 million for the second quarter ended June 30, 2026, compared to a net loss of $42.7 million for the same period in 2025. The $2.1 million increase in net loss was primarily due to a $4.7 million increase in research and development expenses driven by increased clinical trial activity and lower interest income, partially offset by lower property and equipment disposal losses, and a $1.4 million long-lived asset impairment charge that did not recur. Non‑GAAP net loss, which excludes non-cash stock-based compensation, non-cash expenses related to the change in the estimated fair value of the Securities Purchase Agreement put/call asset relating to the Company’s July 2025 private placement transaction and success payment liabilities, increased by $2.8 million to $40.6 million for the second quarter ended June 30, 2026, compared to $37.8 million for the same period in 2025, primarily due to increased clinical trial activity and lower interest income.

(Press release, Lyell Immunopharma, AUG 6, 2026, View Source [SID1234669799])

On August 6, 2026 Ligand Pharmaceuticals Incorporated (Nasdaq: LGND) reported financial results for the three and six months ended June 30, 2026, and provided an operating forecast and business update. Ligand management will host a conference call and webcast today at 8:30 a.m. Eastern Time to discuss the results and answer questions.

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"Ligand delivered another strong quarter, with royalty revenue growing 32% year-over-year and continued momentum from Filspari following its FSGS approval by the FDA," said Todd Davis, CEO of Ligand. "During the quarter, we also completed a $700 million convertible debt financing at a 0% interest rate, giving us access to low cost capital while maintaining a disciplined capital structure. Shortly after quarter-end, we closed our acquisition of XOMA Royalty, adding more than 120 commercial, clinical and preclinical-stage assets to our portfolio and further diversifying our royalty base across therapeutic areas, development stages, and partners. This transaction meaningfully strengthens our position as a leading biopharma royalty aggregator and, combined with our broadened portfolio, positions Ligand for a strong second half of 2026 and beyond."

Second Quarter 2026 Financial Results
Second-quarter 2026 results reflect continued strong momentum in the royalty business, with royalty revenue increasing 32% year-over-year.
Total revenues and income for the second quarter of 2026 were $63.7 million, compared with $47.6 million for the same period in 2025. The 34% increase was primarily driven by higher royalty revenue. Royalties totalled $48.0 million, compared with $36.4 million in the prior-year period, with the 32% increase primarily attributable to royalties earned on Travere Therapeutics’ Filspari, Pelthos Therapeutics’ Zelsuvmi, and Merck’s Ohtuvayre. Captisol sales were $8.0 million, compared with $8.3 million in the second quarter of 2025. Contract revenue and income were $7.7 million compared with $2.9 million in the prior-year period, with the increase primarily attributable to the timing of milestone events under partner agreements.

Cost of Captisol was $3.2 million for the second quarter of 2026, compared with $2.9 million in the same period of 2025, reflecting lower gross margins due to changes in customer mix. Amortization of intangibles was $8.1 million, compared with $8.3 million in the prior-year period. Research and development expense was $14.7 million, compared with $6.6 million in the second quarter of 2025. The increase was primarily driven by the $12.3 million research and development funding arrangement with Orchestra BioMed, partially offset by the absence of research and development expenses associated with our former Pelthos business following the deconsolidation of LNHC, Inc. on July 1, 2025. General and administrative expense was $29.1 million compared with $20.2 million in the prior-year period. The increase was primarily attributable to transaction costs associated with the XOMA Acquisition, as well as higher employee-related costs, including increased headcount and share-based compensation, reflecting the Company’s continued investment in its origination and portfolio management functions.

Net non-operating income was $55.7 million for the second quarter of 2026, compared with $2.8 million in the same period of 2025. The increase was primarily driven by a $35.7 million non-cash gain related to changes in the fair value of the Company’s investments in Pelthos Therapeutics’ common stock and Series A convertible preferred stock, a $10.8 million increase in gains on short-term investments, and a $5.1 million increase in net interest income.
GAAP net income was $48.5 million, or $2.22 per diluted share for the second quarter of 2026, compared with $4.8 million, or $0.24 per diluted share, for the same period in 2025. Adjusted net income for the second quarter of 2026 was $50.8 million, or $2.37 per diluted share, compared with $32.0 million, or $1.60 per diluted share, for the same period in 2025, representing year-over-year growth of 59% and 48%, respectively. The increase was primarily driven by the 32% year-over-year growth in royalty revenue. Adjusted net income is a non-GAAP financial measure. See the table below for a reconciliation of GAAP net income to adjusted net income.
Year-to-Date Financial Results
Total revenues and income for the six months ended June 30, 2026 were $115.4 million, compared with $93.0 million for the same period in 2025. The 24% increase was primarily driven by higher royalty revenue. Royalties for the six months ended June 30, 2026 were $91.0 million, compared with $63.9 million for the prior year period, with the 42% increase primarily attributable to royalties earned on Travere Therapeutics’ Filspari, Pelthos Therapeutics’ Zelsuvmi, and Merck’s Ohtuvayre and Capvaxive. Captisol sales were $16.6 million, compared with $21.7 million for the same period in 2025, with the decrease primarily reflecting the timing of customer orders.
Cost of Captisol for the six months ended June 30, 2026 was $6.5 million, compared with $7.8 million for the same period in 2025, primarily due to lower Captisol sales. Research and development expenses were $16.8 million for the six months ended June 30, 2026, compared with $56.7 million for the same period in 2025. The decrease was primarily driven by the absence of the $44.3 million research and development funding charge recognized in the first quarter of 2025 in connection with the D-Fi royalty rights acquired in the Castle Creek Transaction, as well as the absence of $6.4 million of research and development expense associated with our former Pelthos business following the deconsolidation of LNHC, Inc. on July 1, 2025. These decreases were partially offset by the $12.3 million research and development funding arrangement expense recognized in the second quarter of 2026 related to Orchestra BioMed. General and administrative expense were $50.0 million for the six months ended June 30, 2026, compared with $39.0 million for the same period in 2025. The increase was primarily attributable to transaction costs associated with the XOMA Acquisition, as well as higher employee-related costs, including increased headcount and share-based compensation, reflecting the Company’s continued investment in its origination and portfolio management functions.
Non-operating income, net, was $14.1 million for the six months ended June 30, 2026, compared with non-operating expense, net, of $11.2 million for the same period in 2025. The $25.3 million year-over-year improvement was primarily driven by a $27.1 million increase in gains on short-term investments and a $9.1 million increase in net interest income, partially offset by a $13.5 million non-cash loss related to changes in the fair value of the Company’s investments in Pelthos Therapeutics common stock and Series A convertible preferred stock.
GAAP net income was $35.2 million, or $1.63 per diluted share for the six months ended June 30, 2026, compared with GAAP net loss of $37.6 million, or $1.95 per share, for the same period in 2025. Adjusted net income for the six months ended June 30, 2026 was $85.4 million, or $4.00 per diluted share, compared with $58.6 million, or $2.94 per diluted share, for the same period in 2025, representing year-over-year growth of 46% and 36%, respectively. The increase was primarily driven by the 42% year-over-year growth in royalty revenue. Adjusted net income is a non-GAAP financial measure. See the table below for a reconciliation of GAAP net income (loss) to adjusted net income.

As of June 30, 2026, Ligand had cash, cash equivalents, and short-term investments of $1.36 billion, compared with $733.5 million at December 31, 2025. The increase was primarily driven by the proceeds from the Company’s issuance of its convertible senior notes due 2031.
Following the completion of the XOMA Acquisition, Ligand has approximately $700 million of deployable capital available to pursue additional royalty acquisitions and strategic investments.

2031 Convertible Debt Financing

On June 25, 2026, Ligand completed its offering of $700 million aggregate principal amount of 0.00% convertible senior notes due 2031, including the full exercise of the initial purchasers’ option to purchase additional notes.
Net proceeds from the offering were approximately $679 million, after deducting fees and expenses. Ligand used approximately $82 million of the net proceeds to enter into a call spread overlay, consisting of convertible note hedge and warrant transactions, and approximately $60 million to repurchase 228,859 shares of its common stock at a price of approximately $262 per share.
The convertible note hedge transactions are intended to reduce the potential for dilution to Ligand’s common stock upon conversion of the notes. The warrant transactions increase the effective conversion price such that the warrants will not result in dilution unless Ligand’s common price exceeds $524.34 per share.
Ligand expects to use the remaining net proceeds from the offering for general corporate purposes, including potential royalty acquisitions, strategic investments, and other growth initiatives.

Ligand is reaffirming its 2026 full-year revenue guidance and is raising the low end of its adjusted earnings per diluted share guidance range, reflecting stronger than previously anticipated cost synergies from the XOMA Acquisition, incremental net interest income resulting from proceeds of the 2031 Notes, and reduced share count following the Company’s share repurchase in connection with the convertible debt financing. Ligand continues to expect the following:

•Full-year 2026 royalty revenue to be in the range of $225 million to $250 million
•Revenue from sales of Captisol is unchanged at $35 million to $40 million
•Contract revenue of $10 million to $20 million
•Total revenue of $270 million to $310 million
•Adjusted earnings per diluted share1 of approximately $9.00 to $9.50 for the full year (previously $8.50 to $9.50)
This guidance reflects the completion of the XOMA Acquisition on its previously anticipated timeline, consistent with the partial-year contribution contemplated in guidance issued earlier this year.
XOMA Acquisition

On July 14, 2026, Ligand announced completion of the acquisition of XOMA Royalty, a biotechnology royalty aggregator. Details of the transaction are as follows:
•Each outstanding share of XOMA Royalty common stock was converted into the right to receive (i) $39.00 in cash and (ii) one contingent value right (CVR) representing the holder’s right to receive potential future payments derived from the CVR trust’s interest in XOMA Royalty LLC in connection with the Holding Company Reorganization (as defined in the merger agreement);
•The closing of the transaction met Ligand’s original timeline expectations. We believe the transaction will be immediately accretive and to add approximately $0.50 and $1.50 per share to Ligand’s projected 2026 and 2027 adjusted earnings per share2; and
•Ligand funded the transaction through cash on hand and expects to retain sufficient capital capacity to continue executing its capital deployment strategy of investing approximately $150 million to $250 million annually in high-value royalty assets.

The XOMA Acquisition strengthens Ligand’s royalty portfolio by adding seven commercial products, including Roche’s VABYSMO (faricimab-svoa), Servier’s OJEMDA (tovorafenib), and Zevra Therapeutics’ MIPLYFFA (arimoclomol). Additionally, the acquisition adds 14 late-stage development programs, featuring Takeda’s mezagitamab and certain assets from Takeda’s externalized asset portfolio, such as osavampator, volixibat, and OHB-607, along with more than 100 assets in various stages of development to Ligand’s portfolio. As a result, Ligand’s portfolio has more than doubled in size, now comprising over 200 commercial, clinical, and preclinical stage royalty assets.
Key Portfolio Developments
Filspari
•On April 13, 2026, Travere announced the U.S. Food and Drug Administration (FDA) approved Filspari to reduce proteinuria in adult and pediatric patients aged 8 years and older with focal segmental glomerulosclerosis (FSGS), in patients without nephrotic syndrome. Filspari is currently the first and only medicine approved by the FDA for the treatment of FSGS, marking its expansion beyond IgA nephropathy (IgAN) into a second rare kidney disease.
•On June 19, 2026, Chugai announced that it filed a new drug application in Japan for sparsentan for the treatment of IgA Nephropathy.
•On August 4, 2026, Travere reported U.S. net product sales of Filspari of $141 million, representing 96% year-over-year growth driven by the strong FSGS launch and continued IgAN growth.
Ohtuvayre
•On August 4, 2026, Merck reported net sales of Ohtuvayre of $204 million with net product sales including a benefit from the timing of specialty pharmacy purchases in the U.S.
Qtorin rapamycin
•On May 4, 2026, Palvella announced the first patients have been dosed in LOTU, a Phase 2 clinical trial designed to evaluate the safety and efficacy of Qtorin rapamycin for the treatment of clinically significant angiokeratomas. Clinically significant angiokeratomas represent a rare, chronic and debilitating lymphatic malformation with no FDA approved therapies and an estimated more than 50,000 diagnosed patients in the U.S. Topline results from the Phase 2 trial are expected in the second half of 2027.
•On June 29, 2026, Palvella announced submission of the first module of its rolling NDA to the FDA seeking approval of Qtorin 3.9% rapamycin for the treatment of microcystic lymphatic malformations (microcystic LMs). Palvella remains on track to submit the remaining modules and complete the NDA submission in the second half of 2026.
•On August 4 2026, Palvella announced the Phase 3 trial of Qtorin rapamycin for the treatment of cutaneous venous malformations is planned for the fourth quarter of 2026.
Capvaxive
•On June 18, 2026, Merck announced the FDA approved an expanded indication for Capvaxive to include children and adolescents aged 2 through 17 years who have completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that put them at an increased risk for pneumococcal disease. With this approval, Capvaxive is the only pneumococcal conjugate vaccine (PCV) specifically indicated and studied in the U.S. for use in this patient population.
•On August 4, 2026, Merck reported net sales of Capvaxive of $184 million, an increase of 42% with the increase primarily driven by launch uptake in several international markets, particularly Asia Pacific and Europe as well as in the U.S.
Tzield
•On June 12, 2026, Sanofi announced the FDA granted accelerated approval in children aged 8 to 17 years recently diagnosed with stage 3 type 1 diabetes ("T1D") to delay the decline in endogenous insulin production. Tzield is the first disease-modifying therapy for patients recently diagnosed with stage 3 T1D.

AVIM Therapy/VIRTUE SAB
•On May 6, 2026, Ligand fulfilled the previously scheduled tranche payment of $15 million to Orchestra BioMed under the royalty-based financing agreement.
•On May 12, 2026, Orchestra BioMed announced that it is targeting enrollment completion in the AVIM Therapy BACKBEAT trial in the third quarter of 2026. The updated timeline is supported by FDA approval of a reduction in sample size for the BACKBEAT trial to a target total of 284 evaluable randomized subjects, with a total enrollment target of 316 patients accounting for potential loss to follow-up. Orchestra BioMed is targeting top line data in the second quarter of 2027.
BOT/BAL
•On July 13, 2026, Agenus entered into a securities purchase agreement for a private placement of approximately $85 million in upfront gross proceeds, before the deduction of private placement expenses, and up to an additional $255 million upon the full exercise of purchase warrants. The financing was led by Commodore Capital, with participation from RA Capital Management, TCGX, Invus, and Ligand.
•On July 13, 2026 Agenus announced the discontinuation of the BATTMAN Phase 3 trial evaluating BOT/BAL in late-line metastatic microsatellite-stable (MSS) colon cancer and has reached alignment on key elements of the new ROBBIN Phase 3 trial design with the FDA. First dosing of the ROBBIN trial for the neoadjuvant treatment of MSS colon cancer is expected in the first quarter of 2027.
Lasofoxifene
•On May 7, 2026, LeonaBio announced it is amending the ELAINE-3 trial protocol to increase the sample size from 500 participants to up to 600 participants. The primary goal of the amendment is to help ensure that the trial will have the appropriate number of disease progression events. The Company expects to complete enrollment of the Phase 3 ELAINE-3 clinical trial in the fourth quarter of 2026 and to have topline data in the second half of 2027.
Ojemda
•On April 22, 2026, Ipsen announced Ojemda was granted conditional marketing authorization in the European Union as monotherapy for the treatment of patients 6 months of age and older with pediatric low-grade-glioma harboring a BRAF fusion or rearrangement, or BRAF V600 mutation, who have progressed after one or more prior systemic therapies.
Volixibat
•On May 4, 2026, our partner announced the primary endpoint was met in the VISTAS Phase 2b study evaluating volixibat, an investigational oral ileal bile acid transporter (IBAT) inhibitor, in patients with primary sclerosing cholangitis (PSC). Volixibat demonstrated a statistically significant and clinically meaningful 2.72 point reduction in the primary endpoint of cholestatic pruritus.
•On August 5, 2026, our partner announced volixibat was granted Breakthrough Therapy Designation for cholestatic pruritus due to PSC. Additionally, a pre-NDA meeting was held for volixibat in cholestatic pruritus due to PSC and additional discussions are planned before potential NDA submission.
•On August 5, 2026, our partner announced enrollment was completed in the VANTAGE Phase 2b study of volixibat in cholestatic pruritus due to primary biliary cholangitis (PBC) with topline results expected in Q1 2027.
Ersodetug
•On June 2, 2026, Rezolute announced positive interim data for its Phase 3 Uplift study in Tumor hyperinsulinism. The company expects to announce topline results for the fully enrolled open-label study in the second half of 2026.

Adjusted Financial Measures
Ligand reports adjusted net income from continuing operations, adjusted net income per diluted share and adjusted earnings per diluted share in addition to, and not as a substitute for, financial measures calculated in accordance with GAAP, and does not consider such measures superior to GAAP results. The Company also reports "core" versions of these measures, which exclude any gains on the sale of the Pelthos business.

Adjusted earnings per diluted share is a key component of the financial metrics utilized by the Company’s board of directors to evaluate management performance and determine certain elements of management compensation. GAAP results include items such as share‑based compensation expense, amortization of acquisition‑related and intangible assets, changes in contingent liabilities, mark‑to‑market adjustments on investments in public companies, transaction‑related costs and related tax effects, which are excluded from adjusted results and are detailed in the reconciliations included at the end of this press release.
Conference Call and Webcast
Ligand management will host a conference call today beginning at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time) to discuss its results and answer questions. To participate via telephone, please dial (833) 461-5787 using the conference ID 780702347. International participants outside of Canada may use the toll number +1(585) 542-9983. To participate via live or replay webcast, a link is available at www.ligand.com.

(Press release, Ligand, AUG 6, 2026, View Source [SID1234669798])

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])

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])

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])