FDA Guidance Sets Lantern Pharma Inc. (NASDAQ: LTRN) On a Path Toward Realizing Its Clinical Trial Plans for Rare Pediatric Cancer Therapy

• Texas-based clinical-stage biotechnology company Lantern Pharma Inc. is developing a number of clinical trials, using its proprietary drug candidates and computational biology and machine learning platform, to target conditions with unmet medical needs
• A recent Type C meeting with the U.S. Food and Drug Administration provided the company with guidance in working through the regulatory pathway and designing the trial for its investigational therapy LP-184/STAR-001, which will seek a means of battling pediatric brain cancers
• Lantern Pharma is also using drug candidates in trials to combat glioblastoma (“GBM”), triple-negative breast cancer, non-small cell lung cancer in non-smokers, non-Hodgkin’s lymphoma, and other tumors
• Lantern’s meeting with the FDA will help it amend its investigational new drug (“IND”) submission for the potential pediatric central nervous system cancer therapy LP-184/STAR-001 and a planned trial launch in Q1 of 2026
• Two of the company’s current trials achieved a complete response in patients during the past quarter

Clinical-stage cancer technology company Lantern Pharma (NASDAQ: LTRN) is preparing for the launch of a trial targeting a rare pediatric disease, planned for Q1 2026, in the wake of the company’s optimistic meeting with the U.S. Food and Drug Administration (“FDA”) to receive critical guidance on the company’s trial design and the FDA’s regulatory pathway.

Lantern Pharma is developing its clinical trial with the hope of demonstrating the efficacy of its investigational therapy LP-184/STAR-001 in combatting central nervous system (“CNS”) cancers, including Atypical Teratoid Rhabdoid Tumor (“ATRT”). The LP-184/STAR-001 therapy is designed to work synergistically with diuretic (water pill) spironolactone (https://ibn.fm/JksRT) and other potential combination regimens in treating the childhood brain cancers classified as unmet medical needs.

Lantern’s program for ATRT has received Rare Pediatric Disease Designation and Orphan Drug Designation from the FDA, and the company is preparing to submit an investigational new drug (“IND”) amendment.

“We are thrilled with the constructive dialogue and positive feedback from our Type C meeting with the FDA,” Lantern President and CEO Panna Sharma stated in the company’s Sept. 3 news release about the meeting (https://ibn.fm/VgPKC). “This guidance not only reinforces our trial design but also highlights the potential of our AI platform, RADR®, in identifying and optimizing combination regimens like spironolactone for these devastating pediatric CNS cancers.”

Lantern aims to transform cancer treatment through the use of artificial intelligence (“AI”) to identify biomarkers related to the cancers, analyzing genomic data from large populations of individuals to understand disease-related genetic variations. The company then aims to progressively use preclinical modeling to accelerate the development of oncology drugs.

The company’s proprietary computational biology and machine learning platform will be used in the planned Phase 1b/2 trial that will enroll pediatric patients across multiple sites, with primary endpoints focused on progression-free survival, overall response rate, and quality-of-life measures.

Lantern is also using LP-184 in a Phase 1a trial for glioblastoma (“GBM”) and advanced solid tumors such as triple-negative breast cancer (“TNBC”). It also is in a Phase 2 trial using its drug candidate LP-300 for treating non-small cell lung cancer (“NSCLC”) in individuals whose cancer is completely unrelated to smoking tobacco. And the company is using its LP-284 drug candidate in a Phase 1 trial for relapsed or refractory non-Hodgkin’s lymphoma (“NHL”) and other solid tumors.

The trial of LP-300 in combination with chemotherapy has resulted in a complete response for a 70-year-old non-smoker with advanced non-small cell lung cancer after three prior lines of therapy had failed.

“This quarter we observed complete responses in patients across two of our clinical trials, delivering meaningful patient benefit and providing further validation of both the mechanisms and therapeutic potential of our drug candidates,” Sharma said last month (https://ibn.fm/bHsie). “Simultaneously, our team is transforming our AI platform into functional, accessible modules for the broader oncology community. These parallel advances mark a pivotal inflection point in our clinical and technological evolution.”

For more information, visit the company’s website at www.LanternPharma.com.

NOTE TO INVESTORS: The latest news and updates relating to LTRN are available in the company’s newsroom at https://ibn.fm/LTRN

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