Lantern Pharma (NASDAQ: LTRN) reported significant clinical milestones across its AI-driven oncology pipeline, including complete responses in two separate cancer trials, while narrowing its quarterly losses through disciplined cost management. The clinical-stage biotechnology company, which leverages artificial intelligence to accelerate cancer drug development, announced these developments alongside its second quarter 2025 financial results.
Clinical Breakthrough Results Drive Pipeline Progress
The company's LP-300 program achieved a remarkable complete response in a 70-year-old never-smoker patient with advanced non-small cell lung cancer (NSCLC) who had previously failed three prior treatment regimens, including tyrosine kinase inhibitors and immunotherapy. This outcome builds on previously reported data showing an 86% clinical benefit rate and 43% objective response rate in the initial safety lead-in cohort of the Phase 2 HARMONIC™ trial.
"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," said Panna Sharma, CEO & President of Lantern Pharma.
The HARMONIC™ trial has completed enrollment of a 10-patient Japanese cohort and continues advancing across the United States and expansion sites in Asia, with active sites in Taiwan where over 40% of new lung cancer diagnoses occur in never-smokers. Additional clinical data and findings are anticipated in September 2025, including initial safety and response evaluations from the Asian expansion cohort.
LP-284 Demonstrates Activity in Therapeutically Exhausted Patient
In a separate breakthrough, LP-284 achieved complete metabolic response in a 41-year-old patient with aggressive diffuse large B-cell lymphoma (DLBCL) who had exhausted multiple treatment options. The patient had previously failed R-CHOP chemotherapy, CAR-T cell therapy (liso-cel), and bispecific antibody therapy (glofitamab) before achieving complete metabolic response with non-avid lesions after just two cycles of LP-284.
This represents the first complete response observed with LP-284 and supports the drug's synthetic lethal mechanism in treating refractory aggressive lymphomas. The achievement positions LP-284 within a global blood cancer market focused on B-cell cancer estimated at $4 billion annually, with DLBCL representing the largest aggressive lymphoma subtype affecting approximately 200,000 patients globally each year.
LP-184 Advances Toward Phase 2 Studies
Lantern successfully completed enrollment of its LP-184 Phase 1a first-in-human trial with 65 patients across multiple solid tumor indications. The trial established both the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), positioning LP-184 for advancement to planned Phase 1b/2 studies in recurrent triple negative breast cancer (TNBC) and recurrent bladder cancer.
LP-184 has received Fast Track Designations from the FDA for both glioblastoma multiforme (GBM) and triple negative breast cancer (TNBC), along with four Rare Pediatric Disease Designations. Independent research conducted at Johns Hopkins validated Lantern's data, demonstrating that LP-184 significantly extended survival in mouse models of atypical teratoid rhabdoid tumors (ATRT). In the CHLA06 model, median survival increased from 20 days in the control group to 89 days in the LP-184 treatment group, representing a 345% improvement (p<0.0001).
AI Platform Expansion and Commercial Potential
The company enhanced its RADR® platform, which leverages over 200 billion oncology-focused data points and a library of 200+ advanced machine learning algorithms. Key developments include the public launch of PredictBBB.ai™, an AI module for predicting blood-brain barrier permeability with 94% prediction accuracy, 95% sensitivity and 89% specificity.
Lantern also introduced a drug combination prediction module focused on DNA damaging agents and DNA repair inhibitors, addressing a market opportunity where approximately $50 billion is spent annually on the development of combination therapies for cancer. The company plans to make select RADR® modules available to the broader scientific community, creating potential new revenue streams.
Financial Performance and Outlook
Lantern reported a GAAP net loss per share of $0.40 in Q2 2025, improving from $0.46 per share in Q2 2024. Research and development expenses declined from $3.9 million in Q2 2024 to $3.1 million in Q2 2025, reflecting continued disciplined cost management while advancing multiple clinical programs.
The company ended Q2 2025 with $15.9 million in cash, cash equivalents, and marketable securities, compared to $24.0 million as of December 31, 2024. Management believes existing cash reserves will enable funding of operating expenses and capital expenditure requirements at least into June 2026.
Market Opportunities and Strategic Positioning
The treatment of never-smokers with NSCLC represents a market opportunity estimated at over $4 billion annually, with no approved therapies specifically targeted at this population currently available. Lantern is actively exploring collaboration and partnering opportunities to maximize LP-300's commercial potential in multiple geographies.
LP-184 is positioned as a potential blockbuster drug candidate with market potential of $10-12 billion USD in annual revenue, targeting solid tumors and certain brain and pediatric cancers through its mechanism as a next-generation acylfulvene that preferentially damages DNA in cancer cells overexpressing specific biomarkers.
