On May 21, 2026 GENFIT (Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, reported its cash position as of March 31, 2026 and revenues for the first three months of 20261 and provides a corporate update.

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Cash Position & Revenues
Cash position

As of March 31, 2026, the Company’s cash and cash equivalents amounted to €136.1 million compared with €129.5 million as of March 31, 2025, and €101.1 million as of December 31, 2025. In 2026, cash utilization is mainly the result of our research and development efforts (notably NTZ/G1090N, SRT-015, CLM-022, and VS-02 HE in Acute on-Chronic Liver Failure), as well as GNS561 in Cholangiocarcinoma (CCA). Cash utilization is offset by two items received in the first quarter of 2026 – the €17.0 million (US$20.0 million) first commercial milestone recognized at the end of 2025 and collected in early 2026 under the Ipsen Agreement, and the €30.0 million second installment of the Royalty Financing agreement. We expect that our existing cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements beyond the end of 2028, enabling the Company to further develop its R&D pipeline and support general corporate purposes. This is based on current assumptions and programs and does not include exceptional events. This estimation assumes (i) our expectation to receive significant future commercial milestone revenue pursuant to the Ipsen Agreement and Ipsen meeting its sales-based thresholds and (ii) drawing down the third and final, optional installment under the Royalty Financing agreement.

Revenue

Revenue2 for the first three months of 2026 amounted to €9.6 million compared to €2.8 million for the same period in 2025. Revenue for the first three months of both periods was attributable to royalties from sales of Iqirvo3 (elafibranor) from Ipsen.

II. Corporate update and program highlights

The Company confirms previous timelines across all growth platforms.

Ipsen’s Iqirvo (elafibranor) in Primary Biliary Cholangitis (PBC) 4

The strong commercial sales trajectory reported by our partner Ipsen in the first quarter of 2026 is explained by accelerated sales growth in the US driven by a higher number of patients, and strong launches across European countries. Iqirvo’s net sales for the first quarter of 2026 amounted to €78.8m. Full-year 2025 sales amounted to US$208 million, triggering the first US$20 million commercial milestone payment to GENFIT one year ahead of schedule. This momentum also allowed GENFIT to activate, in January 2026, an additional €30 million tranche under GENFIT’s Royalty Financing agreement with HCRx, enhancing financial flexibility without shareholder dilution.

Next steps: On July 30, 2026, Ipsen will publish its sales results for the first semester of 2026. Ipsen confirmed ELSPIRE Phase 3 study readout by end of 2026.

Non-invasive diagnostic technology in Metabolic dysfunction‑Associated SteatoHepatitis (MASH)

The MASH therapeutics market accelerated in 2025, with near blockbuster performance (~US$1 billion in sales) achieved by the first approved drug therapy in its first year of commercialization, increasing the need for large scale, non-invasive diagnostic, further reinforced by the entry of an additional major pharmaceutical company in August. Against this backdrop, U.S. Medicare and Medicaid have taken an initial step by establishing a pricing framework for NASHnext. NASHnext is a diagnostic test developed and commercialized by Labcorp as a Laboratory Developed Test (LDT) under license from GENFIT. It leverages GENFIT’s proprietary non-invasive diagnostic technology to identify patients at risk of progressive MASH and support treatment decision-making. This represents an important progress toward potential reimbursement and broader payer adoption, supported by Labcorp’s US commercial infrastructure.

Next steps: A commercial launch by Labcorp is expected in the coming weeks, with initial access to NASHnext enabled through Labcorp’s on-demand test menu, marking the start of a phased expansion beyond the current clinical trial setting. This rollout is already accelerating, notably in anticipation of upcoming reimbursement. GENFIT plans to host an analyst event to present recent publications demonstrating the clinical utility of its non-invasive (NIS) technology, outline its strategy in MASH diagnostics — including its In Vitro Diagnostics (IVD) approach — and provide a detailed overview of the MASH diagnostics market potential.

Clinical development of GNS561 in Cholangiocarcinoma (CCA)

Following encouraging preliminary data from the ongoing Phase 1b study evaluating investigational drug GNS561 with a MEK inhibitor (MEKi) in KRAS mutated CCA, the Phase 1b dose escalation is progressing as planned.

Next steps: Phase 1b safety data from initial cohorts expected in mid 2026, as planned. Additional data anticipated in the second half of 2026, following study expansion into additional cohorts supported by encouraging preliminary signals.

Clinical development of G1090N/NTZ in Acute-on-Chronic Liver Failure (ACLF)

Positive Phase 1 data reported in early 2026 confirmed the favorable safety profile of G1090N/nitazoxanide (NTZ) and demonstrated multi‑modal biological activity, supporting its continued clinical development across the ACLF disease continuum. In March 2026, NTZ was granted Orphan Drug Designation for the treatment of ACLF.

Next steps: Initiation of a proof‑of‑concept study with nitazoxanide targeted for the second half of 2026, with data expected in 2027.

Ipsen’s elafibranor lifecycle: important potential in PSC (Primary Sclerosing Cholangitis)4

In early 2026, Ipsen announced the initiation of the Phase 3 ELASCOPE study in PSC. The PSC market opportunity is estimated to be comparable in size to the second‑line PBC market. Subject to successful development and regulatory approval of elafibranor in this indication, GENFIT would be eligible to receive additional milestone payments as well as incremental double‑digit royalties.

Next steps: Phase 3 readout, based on clinical outcomes rather than a surrogate endpoint, is expected around 2031.

Preclinical programs

A pipeline update on ongoing research programs is planned for the third quarter of 2026, covering assets across the ACLF continuum (SRT‑015, CLM‑022, VS‑02‑HE and EViv) as well as Urea Cycle Disorders (UCD) with VS‑01‑HAC.

(Press release, Genfit, MAY 21, 2026, https://ir.genfit.com/news-releases/news-release-details/genfit-reports-first-quarter-2026-financial-information-and [SID1234665927])

On May 21, 2026 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported that Fred Vogt, PhD, Interim CEO, President and General Counsel, and Corleen Roche, Chief Financial Officer, will participate in a fireside chat at the 2026 Jefferies Global Healthcare Conference on June 4, 2026, at 1:25 p.m. ET in New York, NY.

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The live and archived webcast will be available at View Source

(Press release, Iovance Biotherapeutics, MAY 21, 2026, View Source [SID1234665943])

On May 21, 2026 Whitehawk Therapeutics, Inc. (Nasdaq: WHWK), a clinical-stage oncology therapeutics company applying advanced technologies to established tumor biology to efficiently deliver improved antibody drug conjugate (ADC) cancer treatments, reported it entered into a new option agreement with Hangzhou DAC for access to CPT113 for use in up to five additional ADC programs. Whitehawk’s ADC platform leverages CPT113 as the core linker-payload technology, adding its own proprietary Carbon Bridge Cysteine Re-pairing (CBCR) bioconjugation process to support improved stability and therapeutic index.

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Per the terms of the option agreement, Whitehawk will select targets and source antibodies, while retaining global rights and full program control for the new ADC programs. Whitehawk anticipates submitting Investigational New Drug (IND) applications for multiple new programs over the next 12-24 months.

"This option agreement reflects our conviction in CPT113 as the core linker-payload foundation of our ADC platform, supported both by increasing external validation and by what we are seeing in our own existing programs. By layering on our proprietary CBCR bioconjugation process, we believe we further enhance ADC stability to deliver potential best-in-class ADCs," said Dave Lennon, PhD, President and Chief Executive Officer of Whitehawk Therapeutics. "With HWK-007 and HWK-016 enrolling, and an IND for HWK-206 anticipated mid-year, we are building execution momentum across our portfolio. We now have the opportunity to further scale our pipeline and advance novel ADC programs toward the clinic in the next 12-24 months."

External Programs Validate CPT113 Linker-Payload Technology

Hangzhou DAC’s DXC006 is a CD56-directed ADC that utilizes CPT113. DXC006 is being evaluated in first-in-human Phase 1 dose escalation/expansion study in China (NCT06224855) in solid tumor populations, including small-cell lung cancer (SCLC), non-small cell lung cancer (NSCLC) and neuroendocrine neoplasms. Data from DXC006 were accepted for oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper). The abstract points to this highly potent linker-payload translating to clinical activity and a favorable safety profile characterized by an absence of key safety concerns typically associated with a Top1i class. These abstract data were as of December 26, 2025.

Separately, at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, Johnson & Johnson disclosed JNJ‑95437446, an amivantamab-based EGFR/MET ADC that uses CPT113. In the poster, JNJ‑95437446 reported preclinical findings that support its ongoing Phase 1 clinical development (NCT07107230).

Whitehawk’s ADC platform builds on the CPT113 linker-payload technology with its proprietary CBCR bioconjugation process. Based on key nonclinical measures, Whitehawk’s CBCR-based ADC platform has demonstrated higher Drug-to-Antibody Ratio (DAR) and improved therapeutic index compared to DXC006. Whitehawk recently reported comprehensive preclinical data for its existing pipeline programs at AACR (Free AACR Whitepaper).

Whitehawk’s Clinical Pipeline

Phase 1 trials for PTK7-directed HWK-007 and MUC16-directed HWK-016 are advancing through dose-escalation, with data expected in the first half of 2027. Based on non-clinical modeling, both programs’ starting dose is expected to be above the anticipated minimally effective dose.

HWK-007 completed the first dose cohort at 2 mg/kg and is enrolling the second cohort at 4 mg/kg. HWK‑007 is being evaluated in patients with non-squamous, EGFR wild-type non-small cell lung cancer; platinum-resistant ovarian cancer; and endometrial cancer (NCT07444814). The design of this Phase 1 study will be presented during a Trials-in-Progress poster at ASCO (Free ASCO Whitepaper).
Title: A phase 1 study of HWK-007, a next-generation, protein tyrosine kinase 7 (PTK7)-targeted antibody-drug conjugate (ADC), in patients with advanced solid tumors
Date & Time: May 30, 2026, 1:30-4:30 PM CDT
Poster: 292b
HWK-016 is enrolling the first dose cohort at 2.5 mg/kg. HWK‑016 is being evaluated in patients with advanced ovarian and endometrial cancers (NCT07470853).

(Press release, Whitehawk Therapeutics, MAY 21, 2026, View Source [SID1234665959])

On May 21, 2026 Obsidian Therapeutics, Inc., a clinical-stage biopharmaceutical company harnessing novel protein-regulation technology to develop engineered tumor-infiltrating lymphocyte (TIL) cell therapies, reported positive Phase 2 results in patients with advanced melanoma from the Phase 1/2 Agni-01 multicenter study of OBX-115. These data will be presented in an oral presentation by Allison S. Betof, M.D., Ph.D., FASCO, associate professor of medicine (oncology), Stanford School of Medicine, on Monday, June 1, 2026, at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL.

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OBX-115 is a novel engineered TIL cell therapy armored with pharmacologically regulatable membrane-bound IL15 and designed to deliver an improved, patient-centric treatment regimen. With its potentially reduced treatment burden driven by option for less-invasive core needle biopsy tumor tissue procurement, exclusively low-dose lymphodepletion (LD) compatible with outpatient administration and elimination of IL2 in the treatment regimen, OBX-115, if approved, has the potential to become a meaningful therapeutic option and expand the cell therapy eligible population of patients with advanced or metastatic melanoma.

Oral Presentation Title: OBX-115 engineered tumor-infiltrating lymphocyte (TIL) cell therapy with regulatable membrane-bound IL15 (mbIL15) in patients with advanced melanoma that has progressed on/after immune checkpoint inhibitors (ICI): Phase 2 results
Session Title: Oral Abstract Session – Melanoma/Skin Cancers
Abstract: #9507
Location: Grand Ballroom S100bc
Session Date and Time: June 1, 8:00AM-11:00AM CT
Presentation Time: 10:12 AM-10:24 AM CT

Data to be presented are from the single-arm open-label Phase 1/2 Agni-01 multicenter study (NCT06060613) assessing the safety and efficacy of OBX-115 in adult patients with advanced melanoma that has progressed following treatment with ICI. Results from the January 22, 2026 data cutoff include 15 patients treated at the recommended phase 2 dose (RP2D), with n=6 from Phase 1 and n=9 from Phase 2.

OBX-115 demonstrated strong efficacy with a 67% objective response rate (ORR) in a difficult-to-treat advanced melanoma patient population

Study conducted in high unmet need melanoma patients, including a majority (93%) who were previously treated with doublet ICI
73% of patients had progression after anti–PD-1 + anti–CTLA-4 doublet therapy, a group with particularly low response rates to subsequent therapy
67% ORR (per RECIST v1.1), including 2 confirmed complete responses (CR) and 8 confirmed partial responses (PR) (compared to 1 CR and 9 PRs in abstract text)
Durable clinical benefit, including 8 of 10 responses ongoing as of the median 4.3 month study follow-up
OBX-115 continues to deliver consistent, favorable safety profile; treatment regimen with low-dose lymphodepletion and no IL2

All patients received low-dose LD, including 4 in the outpatient setting
No dose-limiting toxicities (DLT), treatment-related mortality (TRM), immune effector cell-associated neurotoxicity syndrome (ICANS) or ICU transfers
Majority of treatment-emergent adverse effects (TEAEs) occurring in ≥20% of patients were Grade 2 or less
Dr. Betof commented, "These data highlight OBX-115’s promising safety and efficacy profile, demonstrating the potential for durable benefit with low rates of major safety signals, including no DLTs, ICU transfer or TRM. The notable reduction in patient treatment burden relative to other therapies, driven by attributes such as core needle biopsy tumor tissue procurement and treatment regimen with outpatient-compatible low-dose lymphodepletion and without IL2, could be very beneficial and broaden the number of cell therapy eligible patients."

"Results from the Agni-01 study, including the 67% ORR, with 80% of responses ongoing as of the median 4.3 month study follow up, further emphasize OBX-115’s potential in advanced melanoma. We are highly encouraged by the anticipated benefit demonstrated in patients with difficult-to-treat advanced melanoma, including patients with disease progression following anti–PD-1 combination exposure," said Parameswaran Hari, M.D., M.S., Chief Medical Officer of Obsidian. "We have been in discussions with the FDA, and after reaching alignment on key design elements including eligibility criteria, clinical trial endpoints and drug product potency assay, plan to pursue a single-arm accelerated approval pathway. We look forward to continuing to advance OBX-115 through the clinic and plan to begin treating patients in the registration-enabling cohort of our multicenter study in mid-2026."

Obsidian is also investigating OBX-115 in patients with non-small cell lung cancer (NSCLC) in the Agni-01 trial. NSCLC Phase 1 data are expected in the first half of 2027.

About OBX-115
Obsidian’s lead investigational cytoTIL15 program, OBX-115, is a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15). OBX-115 has the potential, if approved, to become a meaningful therapeutic option for patients with advanced or metastatic melanoma and other solid tumors by leveraging the expected benefits of mbIL15 and Obsidian’s proprietary, differentiated manufacturing process designed to enhance persistence, antitumor activity, and clinical safety of TIL cell therapy. Obsidian is investigating OBX-115 in the phase 1/2 Agni-01 multicenter trial in patients with advanced solid tumors (NCT06060613).

(Press release, Obsidian Therapeutics, MAY 21, 2026, View Source [SID1234665975])

On May 21, 2026 Rgenta Therapeutics, a clinical-stage biotechnology company pioneering the development of a new class of oral small molecules targeting RNA and RNA regulation for oncology and neurological disorders, reported positive preliminary data from its ongoing Phase 1a/b clinical trial of RGT-61159, an oral small molecule targeting MYB, in patients with advanced, relapsed or refractory adenoid cystic carcinoma (ACC) or colorectal cancer (CRC) at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Meeting being held this week in Chicago. The early data supports promising and durable anti-tumor activity in advanced ACC, demonstrated MYB target engagement and an attractive, well-tolerated safety profile at RP2Ds for once-daily oral administration of RGT-61159.

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"While still early, these data are encouraging and supportive of the potential of RGT-61159 as a promising anti-tumor agent with a favorable safety profile in a particularly aggressive form of cancer, ACC," said Dr. Ho, M.D., Chief of Head and Neck Medical Oncology at Memorial Sloan Kettering Cancer Center. "Further, these data demonstrate that RGT-61159 knockdown of MYB protein, an oncogene that drives cancer progression, is a promising approach for treating cancers that over-express MYB. I look forward to the final results from this study and seeing the continued maturity of efficacy, safety and durability data."

Simon Xi, Ph.D., co-founder and chief executive officer of Rgenta added, "These are the first clinical data generated for RGT-61159 and we are pleased with the early results showing an impressive disease control rate and anti-tumor activity in ACC that deepens over time. In addition, RGT-61159 has demonstrated a favorable, well-tolerated safety profile. We look forward to initially advancing RGT-61159 into further development in ACC, an indication with a high unmet need, and plan to expand into other MYB-driven cancers in the future."

Rgenta’s Phase 1a/b clinical trial of RGT-61159 is a multi-center, open-label dose escalation and expansion study in patients with advanced relapsed or refractory ACC or CRC. The Phase 1a/b study is evaluating safety, tolerability, pharmacokinetics, target engagement and clinical efficacy of RGT-61159 in patients with ACC or CRC. Additional information about the Phase 1a/b clinical trial can be accessed at ClinicalTrials.gov (NCT06462183).

Preliminary data from the initial patients in the trial showed clinically meaningful disease control of 84.6% in 39 evaluable patients, with 3 patients achieving partial response according to RECIST criteria (2 confirmed). Responses continued to deepen with longer treatment duration. Patients with partial responses have remained on study for a mean of 8.2 months, while all ongoing patients across the trial have a mean on-study duration of 7.3 months. RGT-61159 was well tolerated with the most common adverse events being fatigue, anemia, diarrhea and nausea.

About RGT-61159
RGT-61159 is an orally available small molecule designed to specifically modulate splicing of the transcription factor MYB resulting in the inhibition of oncogenic MYB protein production, which has the potential to inhibit proliferation or induce cell death of cancer cells that overexpress MYB protein. MYB acts as a master regulator of cell proliferation differentiation processes and its aberrant expression has been demonstrated in multiple forms of human cancer including adenoid cystic carcinoma (ACC), acute myeloid leukemias (AML), T-cell acute lymphoblastic leukemias (T-ALL), colorectal cancer (CRC), small cell lung cancer (SCLC) and breast cancer.

About Adenoid Cystic Carcinoma (ACC)
It is estimated that approximately 200,000 people are living with ACC throughout the world including 11,000 in the US. While it is a rare cancer, ACC is the second most common cancer type arising in the salivary gland and is an aggressive malignancy with a tendency to infiltrate surrounding nerves and metastasize to distant sites. Overactivation of the MYB oncogene has been described as a hallmark of ACC and is noted in over 90% of ACC. Treatment for ACC is extremely challenging and may include surgery and/or radiation, which often fails to control local tumor recurrence and distant metastases. There are no effective targeted therapies available for patients with recurrent and/or metastatic disease. There is thus an unmet medical need for new therapeutic targets and treatment strategies for patients with this fatal cancer.

About Colorectal Cancer (CRC)
CRC is the third most prevalent cancer and the second leading cause of cancer-related mortality worldwide. According to the World Health Organization, in 2022, more than 1.9 million cases of CRC were diagnosed. Despite the improved early detection of CRC and the recent success of targeted therapeutics, approximately 15%-30% of patients present with metastases and 20%-50% of patients with initially localized disease will develop metastases. Patients with relapsed or refractory CRC who have exhausted all the available standard of care therapy options, have a very poor prognosis. MYB is significantly overexpressed in 80-85% of CRC and has been frequently found to be a predictive biomarker of tumor aggressiveness and poor prognosis. Developing novel therapies to treat patients with metastatic CRC remains a major unmet medical need.

(Press release, Rgenta Therapeutics, MAY 21, 2026, View Source [SID1234665991])