Lantern Pharma Inc. (NASDAQ: LTRN) announced promising clinical results and significant advancements in its AI-driven oncology drug development platform as part of its fourth quarter and year-end 2024 financial results. The clinical-stage biopharmaceutical company reported progress across multiple programs while maintaining approximately $24 million in cash reserves as of December 31, 2024.
"With three clinical precision oncology programs actively enrolling patients and critical data milestones on the horizon, we are at the forefront of using AI to transform the cost, pace, and timeline of oncology drug development," said Panna Sharma, CEO & President of Lantern Pharma. "During 2025, we expect to have meaningful clinical readouts from our Phase 1 and Phase 2 programs and continue to launch highly innovative AI modules that can be used to accelerate and transform drug development in oncology."
HARMONIC Trial Shows Promising Results in Never-Smoker NSCLC
The company's Phase 2 HARMONIC trial for LP-300 delivered impressive preliminary results, with an 86% clinical benefit rate and 43% objective response rate in never-smoker non-small cell lung cancer (NSCLC) patients. The trial has expanded globally with sites in Japan and Taiwan, where never-smokers represent 33-40% of new NSCLC cases, compared to just 15% in the United States.
LP-300 is being evaluated in combination with standard-of-care chemotherapy (carboplatin + pemetrexed) in never-smokers with NSCLC adenocarcinoma who have progressed after tyrosine kinase inhibitor (TKI) therapy. The trial aims to enroll approximately 90 patients across the U.S. and East Asia, with additional results expected in Q2 2025.
Preclinical experiments have also demonstrated that LP-300 has mechanistic synergy with several inhibitors, including EGFR, ALK, MET, and RET. The company is developing a clinical protocol to explore LP-300 in combination with TKIs, particularly Osimertinib, in an earlier line setting.
LP-184 Advances with FDA Fast Track Designations
LP-184, Lantern's synthetic lethal drug candidate, received two FDA Fast Track Designations in 2024 for Glioblastoma Multiforme (GBM) and Triple Negative Breast Cancer (TNBC). The drug also secured three additional Rare Pediatric Disease Designations for hepatoblastoma, rhabdomyosarcoma, and malignant rhabdoid tumors.
The Phase 1a trial for LP-184 in multiple solid tumors has progressed to cohort 11, with early indications of clinical activity observed at higher dose levels. During Q4 2024, dose levels 7, 8, and 9 were cleared without safety concerns, and preliminary pharmacokinetic data suggest dose proportionality with exposure. The trial is expected to complete enrollment in Q2 2025.
Lantern has submitted a clinical trial protocol to the FDA for a Phase 1b/2 study in TNBC, evaluating LP-184 in combination with the PARP inhibitor Olaparib. The company plans to initiate this trial in both the US and a leading academic cancer center in Nigeria, subject to clinical priorities and funding.
In collaboration with MD Anderson Cancer Center, LP-184 demonstrated synergy with anti-PD1 checkpoint inhibitors in TNBC, suggesting potential for use in immuno-oncology combinations. The drug showed the ability to transform immunologically "cold" tumors into "hot" tumors by reshaping the tumor microenvironment and modulating T-cell activity in preclinical models.
LP-284 Shows Promise in Lymphoma and Beyond
LP-284 continued enrollment in its Phase 1A first-in-human clinical trial for relapsed/refractory non-Hodgkin's lymphoma and solid tumors. No dose-limiting toxicities have been observed through cohort 4. The drug has shown nanomolar potency in multiple preclinical cancer models, including tumors resistant to Ibrutinib and Bortezomib.
Beyond oncology, LP-284 has demonstrated potential as a potent B-cell depleter, showing significant potency in reducing clonal CD-19+ and CD-20+ B cells. Lantern believes this mechanism could be redirected as a potential therapeutic for autoimmune disorders, including lupus nephritis, with early preclinical data expected in Q2 2025.
RADR® AI Platform Reaches 100 Billion Data Points
Lantern's proprietary RADR® AI platform surpassed 100 billion oncology-focused data points in 2024, accelerating precision drug development initiatives. The platform continues to advance drug candidate optimization, development of clinically relevant drug combinations, identification of mechanisms of action, and creation of biomarker signatures to support patient selection.
The company showcased industry-leading capabilities in CNS therapeutic development using AI with a patent-pending blood-brain barrier (BBB) permeability prediction algorithm. Lantern's algorithms hold five of the top eleven rankings on the Therapeutic Data Commons leaderboard, with processing capabilities of 100,000 molecules per hour at industry-leading accuracy rates.
Lantern also unveiled an innovative AI-powered antibody-drug conjugate (ADC) development module that identified 82 promising targets and 290 target-indication combinations. This technology potentially reduces development timelines by 30-50% and preclinical costs by up to 60% compared to traditional ADC development approaches.
Starlight Therapeutics Advances CNS Cancer Programs
Lantern's wholly owned subsidiary, Starlight Therapeutics, made key strides in 2024 toward developing potential therapies for CNS and brain cancers. LP-184, referred to as STAR-001 for CNS indications, was highlighted at the Society for Neuro-Oncology (SNO) 2024 conference, with a Phase 1b trial in recurrent GBM anticipated to begin in 2025, subject to additional funding.
The company unveiled a recurrent GBM trial design featuring an innovative STAR-001+spironolactone combination regimen that leverages synthetic lethality. Starlight also assembled a world-class Scientific Advisory Board from leading institutions including Johns Hopkins, UCSF, and Memorial Sloan Kettering.
Financial Results
For the fourth quarter of 2024, Lantern reported:
- Cash, cash equivalents, and marketable securities of approximately $24.0 million as of December 31, 2024
- Research and development expenses of approximately $4.3 million
- General and administrative expenses of approximately $1.6 million
- Net loss of approximately $5.9 million ($0.54 per share)
For the full year 2024, the company reported a net loss of $1.93 per share, compared to $1.47 per share for fiscal year 2023.
Lantern Pharma's AI-driven pipeline of innovative product candidates is estimated to have a combined annual market potential of over $15 billion USD and could potentially provide life-changing therapies to hundreds of thousands of cancer patients worldwide. The company's approach has accelerated drug development, with new programs advancing from initial AI insights to first-in-human clinical trials in 2-3 years at approximately $1.0-$2.5 million per program.
