Enfortumab Vedotin-ejfv

Investigator-initiated European study will evaluate a distinctive dual-biomarker precision-oncology strategy — PTGR1 overexpression combined with tumor-specific Nucleotide Excision Repair — in patients with advanced urothelial cancer who have exhausted standard therapies. No FDA approved therapy for Nucleotide Excision Repair Deficient (NERD) tumors exists. The company estimates that approximately 20% to 25% of bladder cancer cases progress to a need for therapy in the third line representing 130,000+ patients globally and a potential market opportunity of $3+ billion USD by 2035 DALLAS--(BUSINESS WIRE)--Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage, AI-native biopharma company using its proprietary RADR® artificial intelligence and machine-learning platform to develop precision oncology therapies, today announced that an investigator-initiated Phase 1b/2 clinical trial of its lead drug candidate LP-184 (zirdafulven) in advanced, recurrent bladder cancer has been cleared by the European Medicines Agency (EMA). The study will be conducted at Rigshospitalet in Copenhagen — Denmark’s national referral center for urologic cancers — in collaboration with Professor Helle Pappot, MD, DMSc, a leading authority in the treatment of urothelial cancer. The trial is designed to test a novel, biomarker-guided approach in patients with advanced or metastatic urothelial carcinoma who have progressed on or are ineligible for current standard-of-care regimens. It is among the first studies to prospectively select patients using a dual biomarker strategy — combining overexpression of the activating enzyme PTGR1 with tumor DNA-damage-repair (DDR) deficiency — to match the mechanisms of LP-184 to the tumors believed most likely to respond. “This trial reflects exactly the kind of biomarker-guided development that our RADR® platform was built to enable — matching the right molecule to the right patient based on the underlying biology of the tumor. We are proud to collaborate with Professors Rohrberg and Pappot and the world-class team at Rigshospitalet, whose expertise in urothelial cancer makes them an ideal partner. This independent European study can generate an important clinical signal for LP-184 while we continue our plans to advance its broader biomarker-guided program across multiple cancers.” — Panna Sharma, President and Chief Executive Officer, Lantern Pharma ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); LP-184 BLADDER CANCER TRIAL DESIGN AT A GLANCE ▪ Sponsor & design: Investigator-initiated, open-label Phase 1b/2 study ▪ Study site: Rigshospitalet , Copenhagen, Denmark ▪ Clinical Investigators: ➢ Prof. Kristoffer Staal Rohrberg, MD, PhD - Sponsor & Principal Investigator ➢ Prof. Helle Pappot, MD, DMSc – Coordinating Investigator ▪ Indication: Advanced / metastatic urothelial carcinoma (bladder cancer) ▪ Line of therapy: Relapsed / refractory after standard of care (≥ 2nd line; includes patients treated after enfortumab vedotin + pembrolizumab) ▪ Patient selection: Dual biomarker — PTGR1 overexpression + DNA-damage-repair (NER / HR) deficiency ▪ Route & schedule: IV, administered on Days 1 and 8 of each 21-day cycle ▪ Primary endpoint: Objective response rate (ORR) by RECIST 1.1 ▪ Planned enrollment: Up to approximately 39 patients ▪ Regulatory status: Cleared by the European Medicines Agency (EMA) ▪ Market & unmet need: ➢ Bladder cancer is a top-ten global cancer (~550,000 new cases per year; ~84,500 in the U.S. in 2026; ~2,000 per year in Denmark, up to 20% metastatic or unresectable at diagnosis). Options after first-line therapy are limited and non-standardized; the global metastatic urothelial carcinoma market is projected to grow from ~$3.7B (2025) to ~$12.8B by 2035. ➢ The development opportunity for LP-184 is initially aimed at the third-line setting — reached by ~25% of patients — representing an estimated ~137,500 eligible patients globally per year, with the majority of the commercial opportunity concentrated in the United States, Europe, and Japan. Addressing a Growing Unmet Need in Advanced Bladder Cancer Bladder cancer is among the ten most common cancers worldwide, with approximately 550,000 new cases diagnosed each year — including an estimated 84,500 in the United States in 2026. In Denmark, roughly 2,000 patients are diagnosed with bladder tumors annually, and up to 20% present with metastatic or unresectable disease. Following the adoption of enfortumab vedotin plus pembrolizumab as a first-line standard of care for advanced urothelial cancer, patients who progress have few effective options and generally modest outcomes, with no clearly established standard for later lines of therapy. The scale of that gap was quantified in the recently published multicenter STATES-Bladder real-world study (Urologic Oncology, 2026), which followed 180 patients with metastatic urothelial cancer treated in routine practice across four centers in France. Despite a median overall survival of 22.4 months, the study documented sharp attrition across treatment lines: only about one in four patients (25%) reached a third line of therapy, and just 6% reached a fourth — evidence that a large fraction of patients never benefit from later-line options and that mechanistically differentiated therapies are needed in the disease course. Lantern plans to position LP-184 initially in the third-line setting of advanced, metastatic bladder cancer where there is a high need for novel, mechanistically differentiated, biomarker driven therapy options. With roughly 25% of patients reaching third-line therapy, this represents an estimated addressable population of approximately 137,500 patients globally each year, with the majority of the commercial opportunity concentrated in the United States, Europe, and Japan. This persistent unmet need is further reflected by independent market analysts that value the current metastatic urothelial carcinoma therapy market at roughly $2 billion, with projections approaching $4 billion by 2030. A Mechanistically Distinct, Synthetic-Lethal Rationale LP-184 is an acylfulvene-class prodrug that is selectively activated by the enzyme PTGR1 (prostaglandin reductase 1), which is frequently overexpressed in urothelial and other cancers and has been associated with poorer prognosis. Once activated, LP-184 generates DNA damage that tumors depend on nucleotide-excision repair (NER) to fix. In tumors deficient in NER — particularly those with ERCC mutations — this creates a synthetic-lethal vulnerability, which co-occurring homologous-recombination defects may further sensitize. Approximately 10–15% of metastatic urothelial cancers harbor NER alterations, and PTGR1 overexpression is common in this tumor type. This dual mechanistic strategy — PTGR1 for activation and DDR deficiency for selective killing — is supported by Lantern’s preclinical patient-derived xenograft and isogenic model data and is more specific than most genomic- or protein-only selection strategies being pursued after first-line therapy. While many contemporary trials in this space focus on antibody-drug conjugates, FGFR inhibitors, or homologous-recombination-directed agents, the NER-focused acylfulvene approach remains largely unexploited. The company believes these factors further differentiate this program within the precision-oncology landscape for urothelial cancers. Efficient, Pragmatic & Safety-Led Trial Design With Precision Criteria The open-label study employs a pragmatic two-part design. The Phase 1b portion uses a dose-optimization (de-escalation) approach that begins near the expected therapeutic range — informed by data from LP-184’s completed multi-tumor Phase 1a study (NCT05933265) — rather than escalating from a sub-therapeutic starting dose. Patients treated at that dose then advance directly into the Phase 2 portion, which follows a Simon two-stage design with objective response rate (ORR) by RECIST 1.1 as the primary endpoint. Secondary and exploratory measures include progression-free survival, overall survival, duration of response, patient-reported quality of life, and correlation of PTGR1 and DDR biomarker status with clinical benefit. The study is expected to enroll up to approximately 39 patients. Part of a Broader Biomarker-Guided Program LP-184 (zirdafulven) is a key asset in Lantern’s pipeline and has received Fast Track and Orphan Drug designations from the U.S. FDA across multiple indications, including triple-negative breast cancer. Beyond bladder cancer, Lantern is advancing LP-184 in additional solid-tumor and central-nervous-system settings, using the RADR® AI platform to guide patient selection and combination strategies. This EMA-cleared, investigator-initiated European trial complements those efforts by providing an additional read on LP-184’s activity in a biomarker-selected population. About LP-184 (Zirdafulven) LP-184 (zirdafulven) is an investigational small-molecule acylfulvene prodrug that is selectively activated by the enzyme PTGR1 to induce DNA damage repaired predominantly through the nucleotide-excision-repair pathway. This mechanism is designed to preferentially target tumors with high PTGR1 expression and DNA-damage-repair deficiencies. LP-184 is being developed as a biomarker-guided therapy across multiple solid-tumor and central-nervous-system cancers. It is an investigational agent that has not been approved by the EMA, the U.S. FDA, or any other regulatory authority, and its safety and efficacy have not been established. About Lantern Pharma Lantern Pharma (NASDAQ: LTRN) is a clinical-stage biopharmaceutical company leveraging its proprietary RADR® artificial intelligence and machine-learning platform to transform the cost, pace, and precision of oncology drug development. By integrating large-scale genomic and biological data with advanced machine learning, RADR® is designed to identify the patients most likely to benefit from Lantern’s therapies and to guide biomarker-driven clinical development. The company’s pipeline includes LP-184 (zirdafulven), LP-300, and LP-284, along with its central-nervous-system-focused subsidiary, Starlight Therapeutics. For more information, visit . Selected References 1. Moinard-Butot F, Barbe-Richaud J-B, Baudry E, et al. Real-world treatment sequences and overall survival in metastatic bladder cancer: The STATES-Bladder study. Urologic Oncology: Seminars and Original Investigations. 2026;44:111036. doi:10.1016/j.urolonc.2026.111036. 2. American Cancer Society. Key Statistics for Bladder Cancer. 2026. Available at: cancer.org. 3. Global and Danish bladder cancer epidemiology. Cancers (Basel). 2025;17:1105. 4. Emergen Research. Metastatic Urothelial Carcinoma Market, 2025–2035. Market size and forecast. 5. Kulkarni A, et al. Conditional dependency of LP-184 on prostaglandin reductase 1 is synthetic lethal in cancers with DNA damage repair deficiencies. Molecular Cancer Therapeutics. 2023;22(10):1182. 6. A Study of LP-184 in Patients With Advanced Solid Tumors (Phase 1a). ClinicalTrials.gov identifier NCT05933265. 7. Stormoen, D.R., Lehn, S., Mouw, K.W. et al. Assessing expression patterns of PTGR1, a potential biomarker for acylfulven sensitivity in urothelial carcinoma. Sci Rep 14 , 27448 (2024). Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; our strategic plans to pursue the clinical development of LP-184 in bladder cancer and other types of cancer; the anticipated initiation, design, timing, conduct, and potential of the planned Phase 1b/2 clinical trial of LP-184 (zirdafulven) in bladder cancer; the anticipated benefits of a dual-biomarker patient-selection strategy; our plans to leverage artificial intelligence, machine learning and genomic data to identify patient populations that would likely benefit from LP-184; estimates regarding patient enrollment, patient populations, potential markets and potential market sizes; estimates and plans regarding the continued development of LP-184 and Lantern’s broader pipeline; our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others. Any statements that are not statements of historical fact (including, without limitation, statements that use words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "model," "objective," "aim," "upcoming," "should," "will," "would," or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the planned clinical study discussed in this press release will be conducted as an investigator-initiated study with Rigshospitalet in Copenhagen as the Sponsor, and Lantern Pharma will not be the Sponsor of the clinical study, (ii) the risk that observations in preclinical studies and emerging or preliminary observations in clinical studies do not ensure that later observations, studies and development will be consistent or successful, (iii) the risk that we may not be able to secure sufficient future funding when needed and as required to advance and support our existing and planned clinical trials and operations, (iv) the risk that our research and the research of our collaborators may not be successful, (v) the risk that none of our product candidates has received marketing approval from the FDA, the EMA or any other regulatory authority, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain regulatory marketing approval for our product candidates, (vi) risks related to the unpredictable nature of patient enrollment and the inherent uncertainty of drug development, and (vii) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 30, 2026. You may access our Annual Report on Form 10-K for the year ended December 31, 2025 under the investor SEC filings tab of our website at or on the SEC's website at . Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations. Contacts Media & Investor Contacts Lantern Pharma — Investor Relations Email: IR@lanternpharma.com Phone: (972) 277-1136

Biohaven also announces new clinical supply agreement with Regeneron to evaluate BHV-1530 in combination with cemiplimab (Libtayo®) Early clinical activity observed: Phase 1 dose-escalation data show early tumor reductions in patients with Fibroblast Growth Factor Receptor (FGFR)3-altered and wild-type overexpressing tumors. Signal activity including confirmed partial responses in heavily pretreated patients in multiple tumor types. Differentiated safety profile: No dose-limiting toxicities and no FGFR inhibitor-class toxicities observed, supporting a potentially broader therapeutic index than approved FGFR tyrosine kinase inhibitors (TKIs). Potential to expand the addressable FGFR3 population: Unlike FGFR TKIs, which are restricted to the ~15–20% of metastatic urothelial cancer patients with FGFR3 alterations, BHV-1530 is designed to target FGFR3 regardless of alteration status, including wild-type overexpression seen in approximately 50% of metastatic urothelial cancer cases as well as other tumor types that overexpress FGFR3. Anti-PD-1 combination cohorts planned: Biohaven has entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc. to evaluate BHV-1530 in combination with cemiplimab (Libtayo), building on preclinical data demonstrating synergistic activity between BHV-1530's TopoIx payload and immune checkpoint blockade. NEW HAVEN, Conn. , July 20, 2026 /PRNewswire/ -- Biohaven Ltd. (NYSE: BHVN) (" Biohaven "), a global clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of life-changing therapies to treat a broad range of rare and common diseases, today announced that new data on BHV-1530, its FGFR3-directed antibody-drug conjugate (ADC) using a novel topoisomerase I (TopoIx) payload, will be presented at the European Society for Medical Oncology (ESMO) Congress 2026, to be held October 23-27 in Madrid, Spain . 1019P - Phase 1 study of BHV-1530, a first-in-class FGFR3 ADC in Advanced Tumors October 23, 2026 : 15:15 - 16:00 The new Phase 1 data planned for ESMO will provide a clinically meaningful update to the early Phase 1 data initially disclosed at Biohaven's R&D Day on May 27, 2026 . The new data will include signals of clinical activity demonstrated in the ongoing Phase 1, open-label, dose-escalation study of BHV-1530 in patients with advanced solid tumors. The data from May 27 2026 , showed early signs of antitumor activity in patients with both FGFR3-altered and wild-type overexpressing tumors, and across multiple tumor types. This included a heavily pretreated patient with FGFR3-TACC3 fusion–positive metastatic urothelial cancer who had progressed on four prior lines of therapy, including Padcev (a nectin-4-directed ADC), pembrolizumab, and two FGFR-targeting small molecules. This patient has tolerated BHV-1530 with no FGFR-related toxicity. The data has shown a favorable safety profile, with no dose-limiting toxicities and no FGFR inhibitor–class toxicities, such as hyperphosphatemia, nail disorders, stomatitis, or retinopathy, that commonly constrain dosing and duration of approved FGFR tyrosine kinase inhibitors. Clinical Supply Agreement with Regeneron for BHV-1530 and Cemiplimab Biohaven has entered into a clinical supply agreement with Regeneron Pharmaceuticals, Inc. to evaluate the combination of BHV-1530 and cemiplimab (Libtayo) in patients with solid tumors based upon the emerging monotherapy clinical data and preclinical data demonstrating synergistic activity between BHV-1530 and immune therapy. BHV-1530's TopoIx payload has been demonstrated to generate immunogenic cell death and stimulate an antitumor immune response, providing a compelling mechanistic rationale for combination with checkpoint inhibition. This agreement builds upon the existing clinical supply agreement between Biohaven and Regeneron for BHV-1510, a next-generation TROP2-directed ADC, further deepening the collaborative relationship between the two companies across Biohaven's oncology pipeline. Of note, early clinical data from the BHV-1510 program demonstrate a signal consistent with this thesis, as responses have been observed in multiple patients with prior anti–PD-(L)1 therapy. About BHV-1530 BHV-1530 is an antibody-drug conjugate directed against FGFR3, a validated but underexploited target in urothelial cancer and other FGFR3-driven cancers, and is a first in clinic FGFR3-directed ADC incorporating Biohaven's proprietary TopoIx payload. Unlike approved FGFR tyrosine kinase inhibitors, which are restricted to genomically selected patients and constrained by class-related toxicities, BHV-1530 is designed to target FGFR3 independent of requiring pathway inhibition, with the potential to address both FGFR3-altered and wild-type overexpressing tumors. BHV-1530 is being studied in an ongoing Phase 1 dose-escalation trial in unselected patients with advanced urothelial cancer, head and neck squamous cell carcinoma, and non-small cell lung cancer who have failed standard-of-care therapy, as well as other tumor types harboring FGFR3 genomic alterations. Biohaven plans to initiate combination cohorts evaluating BHV-1530 with anti-PD-1 therapy, including the recently announced combination with cemiplimab (Libtayo), in the second half of 2026. About Biohaven Biohaven Ltd. (NYSE: BHVN) is a biopharmaceutical company focused on the discovery, development, and commercialization of life-changing treatments in key therapeutic areas, including immunology, neuroscience, and oncology. Biohaven is advancing its innovative portfolio of therapeutics, leveraging its proven drug development experience and multiple proprietary drug development platforms. Biohaven's extensive clinical and preclinical programs include Kv7 ion channel modulation for epilepsy; MoDE™ and TRAP™ extracellular protein degradation for immunological diseases; and myostatin inhibition for neuromuscular and metabolic diseases, including obesity. For more information, visit www.biohaven.com. Forward-Looking Statements This news release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the expected timing, conduct, and outcomes of Biohaven's ongoing and planned clinical trials of BHV-1530, including the planned combination with cemiplimab under the clinical supply agreement with Regeneron, the potential therapeutic benefits, efficacy, safety, and tolerability of BHV-1530, and the timing of planned regulatory interactions and filings. The use of certain words, including "continue," "plan," "will," "believe," "may," "expect," "anticipate," "on track," "potential," and similar expressions, is intended to identify forward-looking statements. Investors are cautioned that any forward-looking statements are not guarantees of future performance or results and involve substantial risks and uncertainties. Actual results, developments and events may differ materially from those in the forward-looking statements as a result of various factors, including: the expected timing, commencement and outcomes of Biohaven's planned and ongoing clinical trials; the timing of planned interactions and filings with the FDA; the timing and outcome of expected regulatory filings; complying with applicable U.S. regulatory requirements; the potential commercialization of Biohaven's product candidates and the expected timing thereof; the potential for Biohaven's product candidates to be successful therapies; and the effectiveness and safety of Biohaven's product candidates. Additional important factors to be considered in connection with forward-looking statements are described in Biohaven's filings with the Securities and Exchange Commission, including within the sections titled "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations." The forward-looking statements are made as of the date of this news release, and Biohaven does not undertake any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law. MoDE and TRAP are trademarks of Biohaven Therapeutics Ltd. Libtayo is a registered trademark of Regeneron Pharmaceuticals, Inc. Investor Contact:Jennifer PorcelliVice President, Investor Relationsjennifer.porcelli@biohavenpharma.com+1 (201) 248-0741 Media Contact:Mike BeyerSam Brown Inc.mikebeyer@sambrown.com+1 (312) 961-2502 View original content to download multimedia:https://www.prnewswire.com/news-releases/biohaven-to-present-new-clinical-data-at-esmo-congress-on-bhv-1530-a-novel-fgfr3-directed-adc-with-a-proprietary-topoisomerase-i-topoix-payload-302829238.html SOURCE Biohaven Ltd.