On May 13, 2026 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported financial results for the first quarter ended March 31, 2026, and highlighted recent corporate progress.

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"Our dabogratinib ‘3×3’ strategy continues to advance with steady progress across all three programs," said Todd Harris, Ph.D., Chief Executive Officer of TYRA. "We are taking a differentiated, data-driven approach by aligning our development strategy with the patient journey in FGFR3-driven diseases and conditions. The dosing of the first patient in SURF303 marks an important milestone, as we initiate a potentially registrational study in LG-UTUC that could support TYRA’s first NDA submission. With multiple clinical data readouts expected this year, we remain focused on unlocking the full potential of selective FGFR3 inhibition with oral dabogratinib."

Doug Warner, M.D., Chief Medical Officer of TYRA, commented, "In urologic cancers, we see a significant opportunity to address what we believe is a very challenging treatment paradigm for patients that is currently dominated by procedure-based, intravesical therapies. We are developing dabogratinib as a once-daily (QD) oral therapy designed to maintain continuous pressure on the tumor and, if successful, may represent a meaningful shift in how these patients are treated."

Dr. Warner continued, "In achondroplasia, we believe our approach with oral dabogratinib may also be transformational. Recently presented data demonstrate that prenatal dosing further delayed premature fusion of synchondroses and increased the area of the foramen magnum. These data expand our perspective on the potential benefits of earlier FGFR3 inhibition as we advance BEACH301. We have now cleared the fourth dose level in our safety sentinel cohort and remain on track to report initial results in the fourth quarter of this year."

First Quarter and Recent Corporate Highlights

Dabogratinib 3×3 Strategy

In the first quarter of 2026, TYRA advanced its "dabogratinib 3×3" strategy: developing the first orally available, FGFR3 selective inhibitor in 3 future potentially pivotal clinical studies to support regulatory submissions with the aim to commercialize in 3 potential blockbuster indications: LG-UTUC, IR NMIBC and ACH.

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Phase 2 LG-UTUC Study – SURF303. SURF303 is a Phase 2a/b, multicenter, open-label study designed with pivotal intent to evaluate the efficacy and safety of oral dabogratinib at two QD doses in participants with low grade upper tract urothelial carcinoma (LG-UTUC), a rare cancer where approximately 85% of tumors are driven by FGFR3. The Company has dosed the first patient in SURF303, with initial results expected in 2027.

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Phase 2 IR NMIBC Study – SURF302. SURF302 is a Phase 2, multicenter, open-label clinical study evaluating the efficacy and safety of oral dabogratinib at two QD doses in participants with FGFR3-altered low-grade intermediate risk non-muscle invasive bladder cancer (IR NMIBC). To date, there are more than 20 patients enrolled at US and international trial sites, and the Company expects to report initial three-month complete response data from both dose cohorts in August 2026.
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Phase 2 ACH Study – BEACH301. BEACH301 is a Phase 2, multicenter, open-label, dose-escalation/dose-expansion study evaluating oral dabogratinib in children ages 3 to 10 with achondroplasia (ACH). The study has enrolled the safety sentinel cohort and has successfully cleared four dose levels, with no notable safety events reported to date. The study remains on track, with initial results from the safety sentinel cohort, including 6-month average height velocity and safety data, expected in the fourth quarter of 2026.
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Presented Clinical Progress and New Preclinical Results at Key Scientific/Medical Meetings. During the first quarter of 2026 and in April, TYRA presented posters on dabogratinib for urologic cancers (SURF302 and SURF303 trials-in-progress) at the 2026 ASCO (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium (ASCO GU), and the European Association of Urology Congress (EAU 26). TYRA will also present a trials-in-progress poster on SURF302 at the 2026 American Urologic Association (AUA) meeting. In May 2026, at the Fusion Conference on FGFR Biology, TYRA presented new preclinical results with oral dabogratinib for the treatment of ACH. When administered to pregnant mice from embryonic day 14.5 through birth then to Fgfr3Y367C/+ neonates postnatally, dabogratinib significantly increased the foramen magnum area and resulted in open synchondroses. Prenatal plus postnatal treatment further delayed premature fusion of the synchondroses compared with the postnatal alone treatment protocol (Starrett et al., 2025). Posters associated with these meetings can be accessed on the TYRA website.

Corporate

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Appointed Habib Dable to Board of Directors. In April 2026, TYRA announced the appointment of Habib Dable to its Board of Directors. Mr. Dable brings more than 30 years of leadership experience across the global biopharmaceutical industry, including deep expertise in building and scaling blockbuster franchises and guiding companies through transformative growth. Mr. Dable most recently served as President and Chief Executive Officer of Acceleron Pharma Inc., where he led the company through a period of significant growth culminating in its acquisition by Merck in 2021. Prior to Acceleron, Mr. Dable spent 22 years at Bayer AG in positions of increasing responsibility, including President of U.S. Pharmaceuticals and Executive Vice President, Global Head of Specialty Medicine. During his tenure, he provided leadership across multiple therapeutic areas, including ophthalmology, neurology, hematology, and cardiology, and oversaw the global launch of EYLEA. Mr. Dable currently serves as an advisor at RA Capital Management, L.P.
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Strengthened Balance Sheet with ATM Utilization. In the first quarter of 2026, TYRA received $147.9M in net proceeds, after deducting fees and other expenses, following utilization of the Company’s "at-the-market" offering program, issuing and selling 4,690,532 shares of common stock to a large investment management firm.

SNÅP Platform and Pipeline

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TYRA continued to advance its in-house precision medicine discovery engine, SNÅP, used to develop therapies in targeted oncology and genetically defined conditions.

First Quarter Financial Results

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Cash, Cash Equivalents and Short-Term Investments. As of March 31, 2026, TYRA had cash, cash equivalents and marketable securities of $383.5 million. The Company’s current cash, cash equivalents and marketable securities are expected to allow TYRA to execute on its plans into the second half of 2028.
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Research and Development (R&D) Expenses. R&D expenses for the three months ended March 31, 2026 were $33.5 million compared to $25.0 million for the same period in 2025. The increase was primarily associated with development activities for oral dabogratinib, reflecting ongoing BEACH301 and SURF302 clinical trials and start-up costs for SURF303, partially offset by a decrease in development activities for other programs. Personnel expenses also increased, driven by headcount growth to support expanding clinical and development activities.

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General and Administrative (G&A) Expenses. G&A expenses for the three months ended March 31, 2026 were $8.5 million compared to $6.9 million for the same period in 2025. The increase was primarily driven by higher compensation and other personnel costs, driven by headcount growth.
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Net Loss. First quarter net loss was $39.3 million compared to $28.1 million for the same period in 2025.

Upcoming Anticipated Clinical Milestones:

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SURF303: initial results – 2027
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SURF302: initial three-month complete response data – August 2026
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BEACH301: initial results from safety sentinel cohort – Q4 2026

About Dabogratinib (formerly TYRA-300)

Dabogratinib is TYRA’s lead precision medicine candidate stemming from its in-house SNÅP platform. Dabogratinib is an investigational, oral, FGFR3-selective inhibitor currently in Phase 2 development for the treatment of urologic cancers and skeletal dysplasias, specifically LG-UTUC, IR NMIBC and ACH. We believe dabogratinib was the first orally available, FGFR3 selective inhibitor to enter clinical development, and it has been studied in more than 100 patients to date across multiple clinical studies.

Oral dabogratinib is currently advancing in three Phase 2 clinical trials for LG-UTUC (SURF303), IR NMIBC (SURF302), and ACH (BEACH301). The FDA has granted Orphan Drug Designation and Rare Pediatric Disease Designation to oral dabogratinib for the treatment of achondroplasia.

Please visit the Patients page of our website for more information on our clinical trials.

(Press release, Tyra Biosciences, MAY 13, 2026, View Source [SID1234665640])

On May 13, 2026 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its business update and consolidated financial results for the quarter ending March 31, 2026.

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"We have continued to make solid progress across our priority clinical assets during the first quarter. We are approaching completion of enrollment in the Phase 1 dose escalation and backfill cohorts for IPH4502. In parallel, we have advanced the negotiations for non-dilutive financing options to allow initiation of the lacutamab confirmatory Phase 3 TELLOMAK-3 trial in CTCL. Finally, the Phase 3 PACIFIC-9 trial with AstraZeneca is planned for data readout in the second half of 2026. Separately, we were pleased to see encouraging results from the MATISSE Phase 2 trial presented at the AACR (Free AACR Whitepaper) Annual Meeting 2026. It is exciting to see the continued advancement of our differentiated immunotherapy pipeline for patients with high unmet medical need," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma.

Webcast and conference call will be held today at 1:30 p.m. CEST (7:30 a.m. EDT)

Click here to access the live webcast.

Analysts may also join via telephone to ask questions, click here to register.

This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com.

A replay of the webcast will be available on the Company’s website for 90 days following the event.

1 Including short term investments (€4.9m) and non-current financial instruments (€10.4m).

Pipeline highlights:

Lacutamab (anti-KIR3DL2 antibody):

Cutaneous T-Cell Lymphoma

The planned confirmatory Phase 3 TELLOMAK-3 trial is an open-label, multi-center, randomized, comparative study evaluating lacutamab in patients with Sézary syndrome and mycosis fungoides, who have failed at least one prior systemic therapy.
TELLOMAK-3 includes two cohorts: a confirmatory cohort in Sézary syndrome, intended to support a potential accelerated approval based on existing TELLOMAK Phase 2 data, and a registrational cohort in mycosis fungoides, intended to support full approval. The primary endpoint of the study for both cohorts is progression-free survival (PFS) evaluated by blinded central review.
Following the U.S. Food and Drug Administration (FDA) review of the Phase 3 protocol, with no further comments in November 2025, the trial is planned for initiation in H2 2026.
The FDA provided encouraging feedback on the TELLOMAK Phase 2 results and the proposed regulatory pathway, which may support an accelerated approval in Sézary syndrome once the Phase 3 trial is underway. In February 2025, the FDA granted Breakthrough Therapy Designation to lacutamab for relapsed or refractory Sézary syndrome.
The TELLOMAK Phase 2 trial is completed, and patients still on treatment at the end of the study continue to receive lacutamab through a Post Trial Access program.
An abstract authored by ZS Associates entitled "Cutaneous T-Cell Lymphoma Epidemiology in the United States: A Real-World Data Analysis of Administrative Claims" has been accepted for publication in the official Abstract Book of the European Hematology Association (EHA) (Free EHA Whitepaper) Congress 2026. The analysis, sponsored by Innate, reports approximately 12,400 prevalent patients with mycosis fungoides (MF) and 1,100 with Sézary syndrome (SS), with ~2,900 and ~300 new cases per year, respectively.
Peripheral T-Cell Lymphoma (PTCL)

KILT (anti-KIR in T-Cell Lymphoma) Phase 2 trial, an investigator-sponsored, randomized study led by the Lymphoma Study Association (LYSA) evaluating lacutamab in combination with GEMOX (gemcitabine and oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL, is ongoing.
IPH4502 (Nectin-4 exatecan ADC):

The IPH4502-101 Phase 1 study (NCT06781983), recruiting in France and in the United States, is evaluating the safety, tolerability, and preliminary anti-tumor activity of IPH4502 in advanced solid tumors known to express Nectin-4, including but not limited to urothelial carcinoma, non-small cell lung, breast, ovarian, gastric, esophageal, and colorectal cancers.
The maximum tolerated dose has been reached and enrollment in the Phase 1 dose escalation and cohort enrichment is nearing completion. Preliminary anti-tumor activity continues to be observed in heavily pre-treated patients with advanced solid tumors, including in patients with urothelial cancer relapsed or refractory to enfortumab vedotin, with a favorable safety profile to date.
Monalizumab (anti-NKG2A antibody), developed in collaboration with AstraZeneca:

The PACIFIC-9 Phase 3 trial run by AstraZeneca evaluating durvalumab (anti-PD‑L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following platinum-based chemoradiation therapy (CRT) is ongoing. Enrollment in the trial is complete, and data readout is expected in H2 2026.
Other Clinical stage assets

IPH5201 (anti-CD39 antibody, developed in collaboration with AstraZeneca): The MATISSE Phase 2 trial is evaluating IPH5201 in combination with durvalumab and platinum-based chemotherapy in the neoadjuvant lung cancer setting.

Interim results from MATISSE Phase 2 were presented in a Clinical Trials Plenary Session at the AACR (Free AACR Whitepaper) Annual Meeting 2026 on April 21, 2026 in San Diego, by Pr. Fabrice Barlesi (Institut Gustave Roussy). The pre-planned interim analysis was conducted on 40 patients with resectable early-stage (stage II–IIIA) NSCLC treated with perioperative IPH5201 in combination with durvalumab and platinum-based chemotherapy. The combination showed encouraging results with overall pathological complete response (pCR) rate of 27.5% (95% CI: 14.6–43.9). pCR rates were notably higher in patients with PD-L1-positive tumors, reaching 35.7% in PD-L1 ≥1% patients (n=28%) and 50.0% in PD‑L1 ≥50% patients (n=14). Higher baseline tumor CD39+ and CD8+ cell density was observed in patients achieving pCR/mPR, suggesting CD39 expression as a potentially emerging biomarker. The safety profile was comparable to that of preoperative platinum-based chemotherapy with durvalumab. Based on these encouraging results, the MATISSE study continues enrollment in the PD-L1 ≥1% patient population.
IPH5301 (anti-CD73, proprietary): The investigator-sponsored CHANCES Phase 1 trial of IPH5301 with Institut Paoli-Calmettes is ongoing.

IPH6101 (ANKET anti-CD123, proprietary): Innate has initiated a research collaboration to further assess next steps of development.

IPH6401/SAR’514 (ANKET anti-BCMA, partnered with Sanofi): During the first quarter, Sanofi announced deprioritization of SAR’514, a trifunctional anti-BCMA NK-cell engager. Sanofi retains exclusive development and commercialization rights, and the license terms remain unchanged.

Corporate Update:

As previously announced, in line with its strategic focus, the Company has streamlined its organization. Planned layoffs were implemented through a redundancy plan which is completed.
As of March 31, 2026, the balance available under our April 2023 sales agreement under the At-The-Market program remains at $75 million.
Financial highlights for Q1 2026:

Cash, cash equivalents and financial assets of the Company amounted to €25.4 million as of March 31, 2026. At the same date, financial liabilities amounted to €20.3 million.

Revenue for the three-month period ending March 31, 2026, amounted to €2.6 million (€1.2 million for the same period in 2025). Revenue from collaboration and licensing agreements mainly resulted from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca and Sanofi.

(Press release, Innate Pharma, MAY 13, 2026, View Source [SID1234665656])

On May 13, 2026 Aprea Therapeutics, Inc. (Nasdaq: APRE) ("Aprea", or the "Company"), a clinical-stage precision medicine oncology company focused on the discovery and development of targeted therapies for patients with biomarker-defined cancers, reported financial results for the first quarter ended March 31, 2026, and provided a business update.

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"We are very encouraged by the progress made across both our clinical and corporate priorities during the first quarter of 2026, including two partial responses observed in the ACESOT-1051 trial evaluating APR-1051. One of these has been confirmed at a second imaging assessment and this patient remains on study," said Oren Gilad, Ph.D., President and Chief Executive Officer of Aprea. "These efficacy results, coupled with the encouraging tolerability, support our precision medicine strategy and reinforce the potential of targeted therapies for patients who have limited treatment options. We look forward to presenting an update from ACESOT-1051 at ASCO (Free ASCO Whitepaper) 2026 and providing additional insight into APR-1051’s emerging clinical profile. The recent $30 million private placement significantly strengthens our balance sheet and enables us to meaningfully expand patient enrollment, generating the clinical data needed to inform the future clinical path for APR-1051. We are grateful for the trust and support of both new and existing investors, whose participation reflects confidence in our development strategy and the potential of our programs."

Key Business Updates and Upcoming Key Milestones

ACESOT-1051: A Biomarker Focused, Phase 1 Trial of Oral WEE1 inhibitor, APR-1051

APR-1051 is a potent and selective, oral small molecule WEE1 inhibitor designed to potentially address therapeutic window limitations observed with earlier WEE1 programs. APR-1051 is being evaluated as monotherapy in uterine serous carcinoma patients regardless of mutation, cyclin E-overexpressing platinum-resistant ovarian cancer, advanced solid tumors harboring CCNE1, CCNE2, PPP2R1A or FBXW7 mutations, colorectal cancer harboring KRAS & TP53 mutations and HPV+ head and neck squamous cell carcinoma. These patient populations are associated with poor prognosis and limited effective treatment options.
To date, two patients in ACESOT-1051 have achieved partial responses ("PR"). One uterine carcinosarcoma patient with PPP2R1A-mutation treated at the 220 mg dose level achieved a 50% reduction in target lesion size per RECIST v1.1 criteria and a significant reduction in CA-125 levels at the first imaging assessment. At the confirmatory, second imaging assessment, an additional 9.5% reduction in target lesion size was observed, along with a further decline in CA-125 to 40.2 U/mL from 362 U/mL at baseline. This patient remains on study with an ongoing PR. There has also been an unconfirmed PR in a second patient with PPP2R1A-mutated uterine serous carcinoma, treated at the 150 mg dose level.
A total of 28 patients have been treated in ACESOT-1051 to date at doses ranging from 10 mg to 300 mg once daily. Six patients have achieved best overall response of stable disease, including patients with colorectal cancer, HPV+ head and neck squamous cell carcinoma, and endometrial cancer.
Dose escalation is ongoing with enrollment currently underway in the 300 mg cohort (dose level 9). Additional eligible patients will be backfilled at 220 mg to further characterize safety, tolerability, and clinical activity, once dose level 9 is fully enrolled.
APR-1051 has been shown to be well tolerated; the two most common adverse events have been Grade 1 or 2 nausea and fatigue. No treatment-related class-limiting toxicities, including severe myelosuppression or severe gastrointestinal toxicity, have been observed to date.
Supported by the $30 million financing that closed on March 31, 2026, Aprea is expanding enrollment in ACESOT-1051 to include at least 50 patients with uterine serous carcinoma (USC), as well as patients with cyclin E-overexpressing, platinum-resistant ovarian cancer (PROC). The expansion is intended to provide additional safety, tolerability and preliminary efficacy data to inform the future clinical path for APR-1051. Completion of dose escalation is anticipated in the second quarter of 2027.
Further clinical updates from ACESOT-1051 are expected during Q2 2026. An abstract entitled "Early results from the first-in-human phase 1 study of WEE1 inhibitor APR-1051 in patients with advanced solid tumors (ACESOT-1051)" has been accepted for the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The poster will be presented on May 30, 2026, 1:30 – 4:30pm CT.
For more information on ACESOT-1051, refer to ClinicalTrials.gov NCT06260514.
ABOYA-119: Clinical Trial Evaluating ATR inhibitor, ATRN-119

ATRN-119 is a potent and highly selective first-in-class macrocyclic ATR inhibitor, designed and developed to be used in patients with tumors harboring mutations in DDR-related genes. Cancers with mutations in DDR-related genes represent a high unmet medical need. These patients often have a poor prognosis and currently lack effective therapeutics options.
During 2025 Aprea established 1,100 mg once daily as the recommended Phase 2 dose (RP2D) in the ABOYA-119 clinical trial. The Company strategically paused further enrollment and has started an orderly wind-down of certain clinical trial site activities associated with the monotherapy, as the Company explores ATRN-119 in potential combination approaches that may unlock greater clinical benefit. The Company is currently in discussions with leading academic institutions to evaluate ATRN-119 in combination with radiation in HPV+ head and neck cancer. Additional investigator-led studies evaluating ATRN-119 with immuno-oncology therapies and antibody-drug conjugates are also being explored.
For more information on ABOYA-119, please refer to clinicaltrials.gov NCT04905914.
Corporate

On March 31, 2026, the Company closed an oversubscribed private placement, raising gross proceeds of $30 million. The private placement was led by Soleus Capital with participation from other new investors, including Vestal Point Capital and Squadron Capital Management, existing investors and certain insiders of the Company. Net proceeds will be used for general corporate purposes and research and development expenses, including the addition of more patients with USC (regardless of mutation status) into the ACESOT-1051 study and expansion into cyclin E-overexpressing PROC patients.
In February 2026, the Company appointed Eugene (Gene) Kennedy, MD, as Chief Medical Advisor. Dr. Kennedy is a highly accomplished physician scientist and biopharmaceutical executive with more than 20 years of experience spanning oncology clinical development, regulatory strategy, and senior corporate leadership across public and private biotechnology companies.
Select Financial Results for the First Quarter Ended March 31, 2026

As of March 31, 2026, the Company reported cash and cash equivalents of $46.5 million compared to $14.6 million as of December 31, 2025. The Company believes that its cash and cash equivalents as of March 31, 2026 will be sufficient to meet its currently projected operating expenses and capital expenditure requirements into the first quarter of 2028.

For the first quarter ended March 31, 2026, the Company reported an operating loss of $3.4 million, compared to an operating loss of $4.1 million in the first quarter of 2025.

Research and Development (R&D) expenses were $1.6 million for the quarter ended March 31, 2026, compared to $2.5 million for the first quarter of 2025. The decrease in R&D expense was primarily related to a decrease of $0.8 million related to the ABOYA-119 clinical trial to evaluate ATRN-119, our clinical-stage oral small molecule inhibitor of ATR, which was voluntarily paused in October 2025.

General and Administrative (G&A) expenses were $1.8 million for each of the quarters ended March 31, 2026 and 2025.

The Company reported a net loss of $3.3 million or ($0.22) loss per basic share on approximately 14.7 million weighted-average common shares outstanding for the quarter ended March 31, 2026, compared to a net loss of $3.9 million ($0.66) per basic share on approximately 6.0 million weighted average common shares outstanding for the comparable period in 2025.

(Press release, Aprea, MAY 13, 2026, View Source [SID1234665622])

On May 13, 2026 UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, reported a 36-month duration of response (DOR) of 64.5% (95% CI, 54.6% – 72.8%) by Kaplan-Meier estimate in patients who achieved a complete response (CR) at three months (79.6%) in the pivotal Phase 3 ENVISION trial of ZUSDURI (mitomycin) for intravesical solution. At a median follow-up of 35.5 months, the median DOR had not been reached. These data demonstrate that a substantial proportion of complete responders remained disease-free at three years, and durable outcomes were achieved without the need for maintenance therapy.

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"This update from the pivotal ENVISION trial shows that many patients who achieve a complete response with ZUSDURI remain disease-free through three years," said Sandip Prasad, M.D., M.Phil., Director of Genitourinary Surgical Oncology and Vice Chair of Urology at Morristown Medical Center/Atlantic Health System, NJ, and Principal Investigator of the ENVISION trial. "Among patients who achieved a complete response, the event rate over time has remained stable. Importantly, ZUSDURI’s durability was achieved without maintenance therapy, supporting a treatment approach that can provide lasting disease control while reducing ongoing treatment burden for patients."

As a non-surgical, in-office treatment, ZUSDURI offers patients an opportunity to achieve meaningful disease- and treatment-free living without the burden of repeated TURBT procedures under general anesthesia. The current standard of care for LG-IR-NMIBC is transurethral resection of bladder tumor (TURBT), a surgical procedure typically performed under general anesthesia. Due to high recurrence rates following surgery, patients often undergo multiple TURBTs over their lifetime, leading to a cycle of repeat procedures that can impact quality of life and increase cumulative risk, particularly in older patients with comorbidities. An estimated 59,000 patients with LG-IR-NMIBC recur annually.

"The ENVISION 36-month DOR data reinforce ZUSDURI’s potential to shift the treatment paradigm for recurrent LG-IR-NMIBC," said Mark Schoenberg, M.D., Chief Medical Officer, UroGen. "By delivering durable responses without maintenance therapy, ZUSDURI provides an opportunity to move beyond the cycle of repeated surgical interventions and toward a more durable, lower-burden treatment approach over time."

The most common (≥ 10%) adverse reactions (ARs), including laboratory abnormalities, that occurred in patients were dysuria, increased potassium, increased creatinine, decreased hemoglobin, increased eosinophils, increased aspartate aminotransferase, increased alanine aminotransferase, decreased lymphocytes, urinary tract infection, decreased neutrophils, and hematuria. ARs were mainly mild to moderate. Serious ARs occurred in 12% of patients, including urinary retention (0.8%) and urethral stenosis (0.4%).

About ZUSDURI

ZUSDURI (mitomycin) for intravesical solution is an innovative drug formulation of mitomycin, approved for the treatment of adults with recurrent LG-IR-NMIBC. Utilizing UroGen’s proprietary RTGel technology (a sustained release, hydrogel-based formulation), ZUSDURI is delivered directly into the bladder by a trained healthcare professional using a urinary catheter in an outpatient setting, thereby enabling the treatment of tumors by non-surgical means.

About Non-Muscle Invasive Bladder Cancer (NMIBC)
LG-IR-NMIBC affects around 82,000 people in the United States every year and of those, an estimated 59,000 are recurrent. Bladder cancer primarily affects older populations with increased risk of comorbidities, with the median age of diagnosis being 73 years. Guideline recommendations for the management of NMIBC include TURBT as the standard of care. Up to 70 percent of NMIBC patients experience at least one recurrence, and LG-IR-NMIBC patients are even more likely to recur and face repeated TURBT procedures. Learn more about non-muscle invasive bladder cancer at www.BladderCancerAnswers.com.

About ENVISION
The Phase 3 ENVISION trial is a single-arm, multinational, multicenter pivotal study evaluating the efficacy and safety of ZUSDURI (mitomycin) for intravesical solution as a chemoablative therapy in adult patients with recurrent LG-IR-NMIBC. The Phase 3 ENVISION trial completed target enrollment with 240 patients across 56 sites. Study participants received six once-weekly intravesical instillations of ZUSDURI. The primary endpoint evaluated the CR rate three months after the first instillation, and the key secondary endpoint evaluates durability over time in patients who achieved a CR at the three-month assessment. Learn more about the Phase 3 ENVISION trial at www.clinicaltrials.gov (NCT05243550).

(Press release, UroGen Pharma, MAY 13, 2026, View Source [SID1234665641])

On May 13, 2026 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported its business update and consolidated financial results for the quarter ending March 31, 2026.

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"We have continued to make solid progress across our priority clinical assets during the first quarter. We are approaching completion of enrollment in the Phase 1 dose escalation and backfill cohorts for IPH4502. In parallel, we have advanced the negotiations for non-dilutive financing options to allow initiation of the lacutamab confirmatory Phase 3 TELLOMAK-3 trial in CTCL. Finally, the Phase 3 PACIFIC-9 trial with AstraZeneca is planned for data readout in the second half of 2026. Separately, we were pleased to see encouraging results from the MATISSE Phase 2 trial presented at the AACR (Free AACR Whitepaper) Annual Meeting 2026. It is exciting to see the continued advancement of our differentiated immunotherapy pipeline for patients with high unmet medical need," said Jonathan Dickinson, Chief Executive Officer of Innate Pharma.

Webcast and conference call will be held today at 1:30 p.m. CEST (7:30 a.m. EDT)

Click here to access the live webcast.

Analysts may also join via telephone to ask questions, click here to register.

This information can also be found on the Investors section of the Innate Pharma website, www.innate-pharma.com.

A replay of the webcast will be available on the Company’s website for 90 days following the event.

1 Including short term investments (€4.9m) and non-current financial instruments (€10.4m).

Pipeline highlights:

Lacutamab (anti-KIR3DL2 antibody):

Cutaneous T-Cell Lymphoma

The planned confirmatory Phase 3 TELLOMAK-3 trial is an open-label, multi-center, randomized, comparative study evaluating lacutamab in patients with Sézary syndrome and mycosis fungoides, who have failed at least one prior systemic therapy.
TELLOMAK-3 includes two cohorts: a confirmatory cohort in Sézary syndrome, intended to support a potential accelerated approval based on existing TELLOMAK Phase 2 data, and a registrational cohort in mycosis fungoides, intended to support full approval. The primary endpoint of the study for both cohorts is progression-free survival (PFS) evaluated by blinded central review.
Following the U.S. Food and Drug Administration (FDA) review of the Phase 3 protocol, with no further comments in November 2025, the trial is planned for initiation in H2 2026.
The FDA provided encouraging feedback on the TELLOMAK Phase 2 results and the proposed regulatory pathway, which may support an accelerated approval in Sézary syndrome once the Phase 3 trial is underway. In February 2025, the FDA granted Breakthrough Therapy Designation to lacutamab for relapsed or refractory Sézary syndrome.
The TELLOMAK Phase 2 trial is completed, and patients still on treatment at the end of the study continue to receive lacutamab through a Post Trial Access program.
An abstract authored by ZS Associates entitled "Cutaneous T-Cell Lymphoma Epidemiology in the United States: A Real-World Data Analysis of Administrative Claims" has been accepted for publication in the official Abstract Book of the European Hematology Association (EHA) (Free EHA Whitepaper) Congress 2026. The analysis, sponsored by Innate, reports approximately 12,400 prevalent patients with mycosis fungoides (MF) and 1,100 with Sézary syndrome (SS), with ~2,900 and ~300 new cases per year, respectively.
Peripheral T-Cell Lymphoma (PTCL)

KILT (anti-KIR in T-Cell Lymphoma) Phase 2 trial, an investigator-sponsored, randomized study led by the Lymphoma Study Association (LYSA) evaluating lacutamab in combination with GEMOX (gemcitabine and oxaliplatin) versus GEMOX alone in patients with KIR3DL2-expressing relapsed/refractory PTCL, is ongoing.
IPH4502 (Nectin-4 exatecan ADC):

The IPH4502-101 Phase 1 study (NCT06781983), recruiting in France and in the United States, is evaluating the safety, tolerability, and preliminary anti-tumor activity of IPH4502 in advanced solid tumors known to express Nectin-4, including but not limited to urothelial carcinoma, non-small cell lung, breast, ovarian, gastric, esophageal, and colorectal cancers.
The maximum tolerated dose has been reached and enrollment in the Phase 1 dose escalation and cohort enrichment is nearing completion. Preliminary anti-tumor activity continues to be observed in heavily pre-treated patients with advanced solid tumors, including in patients with urothelial cancer relapsed or refractory to enfortumab vedotin, with a favorable safety profile to date.
Monalizumab (anti-NKG2A antibody), developed in collaboration with AstraZeneca:

The PACIFIC-9 Phase 3 trial run by AstraZeneca evaluating durvalumab (anti-PD‑L1) in combination with monalizumab or AstraZeneca’s oleclumab (anti-CD73) in patients with unresectable, Stage III non-small cell lung cancer (NSCLC) who have not progressed following platinum-based chemoradiation therapy (CRT) is ongoing. Enrollment in the trial is complete, and data readout is expected in H2 2026.
Other Clinical stage assets

IPH5201 (anti-CD39 antibody, developed in collaboration with AstraZeneca): The MATISSE Phase 2 trial is evaluating IPH5201 in combination with durvalumab and platinum-based chemotherapy in the neoadjuvant lung cancer setting.

Interim results from MATISSE Phase 2 were presented in a Clinical Trials Plenary Session at the AACR (Free AACR Whitepaper) Annual Meeting 2026 on April 21, 2026 in San Diego, by Pr. Fabrice Barlesi (Institut Gustave Roussy). The pre-planned interim analysis was conducted on 40 patients with resectable early-stage (stage II–IIIA) NSCLC treated with perioperative IPH5201 in combination with durvalumab and platinum-based chemotherapy. The combination showed encouraging results with overall pathological complete response (pCR) rate of 27.5% (95% CI: 14.6–43.9). pCR rates were notably higher in patients with PD-L1-positive tumors, reaching 35.7% in PD-L1 ≥1% patients (n=28%) and 50.0% in PD‑L1 ≥50% patients (n=14). Higher baseline tumor CD39+ and CD8+ cell density was observed in patients achieving pCR/mPR, suggesting CD39 expression as a potentially emerging biomarker. The safety profile was comparable to that of preoperative platinum-based chemotherapy with durvalumab. Based on these encouraging results, the MATISSE study continues enrollment in the PD-L1 ≥1% patient population.
IPH5301 (anti-CD73, proprietary): The investigator-sponsored CHANCES Phase 1 trial of IPH5301 with Institut Paoli-Calmettes is ongoing.

IPH6101 (ANKET anti-CD123, proprietary): Innate has initiated a research collaboration to further assess next steps of development.

IPH6401/SAR’514 (ANKET anti-BCMA, partnered with Sanofi): During the first quarter, Sanofi announced deprioritization of SAR’514, a trifunctional anti-BCMA NK-cell engager. Sanofi retains exclusive development and commercialization rights, and the license terms remain unchanged.

Corporate Update:

As previously announced, in line with its strategic focus, the Company has streamlined its organization. Planned layoffs were implemented through a redundancy plan which is completed.
As of March 31, 2026, the balance available under our April 2023 sales agreement under the At-The-Market program remains at $75 million.
Financial highlights for Q1 2026:

Cash, cash equivalents and financial assets of the Company amounted to €25.4 million as of March 31, 2026. At the same date, financial liabilities amounted to €20.3 million.

Revenue for the three-month period ending March 31, 2026, amounted to €2.6 million (€1.2 million for the same period in 2025). Revenue from collaboration and licensing agreements mainly resulted from the partial or entire recognition of the proceeds received pursuant to the agreements with AstraZeneca and Sanofi.

(Press release, Innate Pharma, MAY 13, 2026, View Source [SID1234665656])