Lantern Pharma(LTRN) - 2025 Q1 - Quarterly Results

Lantern Pharma Q1 2025 Financial Results and Business Updates Business & Operational Highlights Lantern Pharma advanced LP-184 and LP-300 trials, expanded its RADR® AI platform, and maintained a strong cash position - Enrollment for the LP-184 Phase 1a clinical trial, involving 62-65 patients with solid tumors, is expected to be completed by the end of June 2025[3] - An additional data readout from the HARMONIC™ Trial (LP-300) in never-smoker NSCLC patients is anticipated in Q3 2025, which will include the first data from the Asian expansion cohort[3] - The RADR® AI platform was enhanced with a new module designed to improve the development of antibody-drug conjugates (ADCs)[3] - The company's cash, cash equivalents, and marketable securities of approximately $19.7 million as of March 31, 2025, provide an expected operating runway through at least May 15, 2026[3] AI-Powered Drug Development Pipeline Highlights The company is advancing lead candidates LP-300 and LP-184, with ongoing trials and new FDA clearances LP-300 (HARMONIC™ Trial) - The Phase 2 HARMONIC™ trial is evaluating LP-300 in combination with chemotherapy for never-smokers with NSCLC who have progressed after TKI therapy, with enrollment ongoing in the U.S., Japan, and Taiwan[5] - Preliminary data from the U.S. safety lead-in cohort showed an 86% clinical benefit rate and a 43% objective response rate[6] - Updated results, including data from the Asian expansion cohort, are planned for release in Q3 2025[6] LP-184 - The Phase 1a trial in solid tumors is expected to complete enrollment in June 2025, with a broader clinical data update slated for Q3 2025[7][8] - LP-184 has received FDA Fast Track Designations for Glioblastoma (GBM) and Triple Negative Breast Cancer (TNBC), along with four Rare Pediatric Disease Designations[7] - The FDA has cleared a Phase 1b/2 study in TNBC and another Phase 1b/2 study in NSCLC patients with STK11 and/or KEAP1 mutations[9][10][12] - An investigator-led clinical trial of LP-184 for recurrent bladder cancer is planned to begin in Denmark during Q3 2025[13] RADR® A.I. Platform The RADR® AI platform expanded to 200 billion oncology data points, aiding biomarker strategies and preparing for module commercialization - The RADR® platform has grown to approximately 200 billion oncology-focused data points[14] - The platform has been crucial for developing LP-184's clinical biomarker strategy (PTGR1) and identifying combination strategies, such as with PARP inhibitors[15] - Lantern plans to publicly release validated AI modules for use by collaborators and the research community to aid in specific oncology drug development needs[15] - A proprietary blood-brain barrier (BBB) permeability prediction algorithm was advanced with a favorable PCT patent application report, with a publicly available tool planned for launch in H2 2025[18] Starlight Therapeutics Starlight Therapeutics is preparing for a Phase 1b/2 trial of STAR-001 in GBM, supported by preclinical data, contingent on funding - Starlight Therapeutics is a wholly-owned subsidiary focused on developing therapies for CNS and brain cancers[16] - A Phase 1b/2 trial for STAR-001 (LP-184) in recurrent GBM is anticipated to begin in late 2025, subject to successful additional funding[16] - Collaborators at Johns Hopkins provided independent preclinical confirmation of LP-184's hypersensitivity in rare pediatric brain tumors, supporting a planned pediatric CNS tumor trial[16] First Quarter 2025 Financial Highlights Lantern Pharma ended Q1 2025 with $19.7 million in cash, reporting a reduced net loss of $4.5 million Q1 2025 Financial Summary (vs. Q1 2024) | Financial Metric | Q1 2025 (USD) | Q1 2024 (USD) | | :--- | :--- | :--- | | Cash, Cash Equivalents, & Marketable Securities | ~$19.7 million | Not specified | | Research & Development Expenses | ~$3.3 million | ~$4.3 million | | General & Administrative Expenses | ~$1.5 million | ~$1.5 million | | Net Loss | ~$4.5 million | ~$5.4 million | | Net Loss per Share | $0.42 | $0.51 | - The company's cash position decreased from approximately $24.0 million at the end of 2024 to $19.7 million as of March 31, 2025[22] - As of March 31, 2025, there are outstanding warrants to purchase 70,000 shares of common stock at a weighted-average exercise price of $18.75 per share, which expire on June 10, 2025[22] Forward-Looking Statements This report contains forward-looking statements subject to risks including funding, clinical trial outcomes, and FDA approval processes - The press release includes forward-looking statements regarding future events, financial performance, strategic plans, clinical trial timing, and market potential[23] - Key risks that could cause actual results to differ include the ability to secure future funding, the success of clinical trials, and the ability to obtain FDA marketing approval for its product candidates[23]