On March 27, 2025 Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company leveraging its proprietary RADR artificial intelligence (AI) and machine learning (ML) platform to transform the cost, pace, and timeline of oncology drug discovery and development, reported financial results for the fourth quarter and full year ended December 31, 2024, and provided an update on its portfolio of AI-driven drug candidates, the RADR platform for precision oncology drug development enhancements, and other operational progress (Press release, Lantern Pharma, MAR 27, 2025, View Source [SID1234651525]).
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"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. Lantern is a leader in the development of tech-bio to deliver the next generation of cancer medicines, where success is defined by both AI-driven progress and meaningful patient outcomes," 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."
AI-Powered Drug Development Pipeline Highlights:
LP-300
Lantern’s Phase 2 HARMONIC trial for LP-300 continued to expand globally in 2024 with sites opened in Japan and Taiwan, including at the National Cancer Center Japan. Patient enrollment was initiated in Taiwan and Japan during Q4 of 2024 and is expected to accelerate during 2025. Never-smokers with NSCLC in East Asia represent 33% to 40% of new NSCLC cases, as opposed to the US, where never smokers account for 15% of new NSCLC cases. LP-300 is being evaluated in combination with standard-of-care chemotherapy (carboplatin + pemetrexed) in never-smokers with NSCLC adenocarcinoma who have progressed after TKI therapy. The trial is designed to enroll approximately 90 patients across the U.S. and East Asia.
Phase 2 Clinical Results: Preliminary data from the Phase 2 U.S. safety, lead-in cohort showed an 86% clinical benefit rate and a 43% objective response rate. Additional patient data from the expansion cohort continues to support, at the current time, a similar patient response and clinical benefit rate trend. Lantern plans on sharing additional results, which will include data from patients enrolled in Taiwan and Japan from the expansion cohort, during Q2 of 2025.
Other LP-300 Advancements: Lantern’s RADR platform and in-vitro preclinical experiments have shown that LP-300 has mechanistic synergy with EGFR, ALK, MET, and RET inhibitors. Leading clinicians and KOLs are supportive of the use of LP-300 in combination with TKIs – most notably Osimertinib – in an earlier line setting. Lantern is working on developing a clinical protocol to advance the potential use of LP-300 in this setting.
LP-184
LP-184 continued advancement through a Phase 1a trial in multiple solid tumors, which is targeted to finish enrollment during Q2 of 2025. In 2024, LP-184 received Fast Track Designations from the FDA for both GBM (Glioblastoma Multiforme) and TNBC (Triple Negative Breast Cancer). Additionally, LP-184 received three Rare Pediatric Disease Designations for hepatoblastoma, rhabdomyosarcoma, and malignant rhabdoid tumors, in addition to its existing designation for ATRT. ATRT is an ultra-rare pediatric brain tumor with the genetic hallmark of loss-of-function or deletion of the SMARCB1 gene.
Phase 1a Results: Safety, Tolerability, Pharmacokinetics including MTD Determination – The trial is now on cohort 11, and early indications of clinical activity have been observed at higher dose levels, consistent with preliminary PK data. During Q4 of 2024, dose levels 7, 8, and 9 were cleared without safety concerns, and preliminary PK data suggest dose proportionality with exposure. Enrollment at dose level 9 and above is focused on inclusion of advanced solid tumor patients that have identified DNA damage repair mutations. A broader clinical data update is slated for Q2 2025 when recruitment for the trial is expected to be finished, and complete safety and dose response data is expected to be available.
Future Planned Phase 1b/2 Trials: Lantern has submitted a clinical trial protocol to the FDA for a Phase 1b/2 study in TNBC evaluating a combination regimen with the PARP inhibitor, Olaparib. The FDA has raised no objections to the protocol, and Lantern expects to initiate this trial in both the US and a leading academic cancer center in Nigeria, subject to clinical priorities and funding. An investigator-led study of LP-184 for recurrent bladder cancer is planned to begin in Denmark. This clinical trial will test LP-184 as a monotherapy specifically in advanced bladder cancer patients with DNA damage repair mutations.
Other LP-184 Advancements: LP-184 showed synergy with anti-PD1 checkpoint inhibitors in TNBC, suggesting the potential for use in immuno-oncology combinations for TNBC patients. LP-184 sensitizes immuno-refractory TNBCs to anti-PD1 therapy by affecting the tumor microenvironment as shown in preclinical models. This work was done in collaboration with MD Anderson and was recently presented at the AACR (Free AACR Whitepaper) IO Conference in February of 2025. During Q4 2024, Lantern completed a CRISPR-focused academic collaboration focused on highlighting and validating pathways and targets that show increased sensitivity to LP-184. These results and how they impact plans for potential upcoming trials will be further detailed in upcoming scientific communications.
LP-284
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. LP-284 has shown nanomolar potency in multiple preclinical cancer models, including tumors that are resistant to Ibrutinib and Bortezomib.
Other LP-284 Advancements: LP-284 is a potent B-cell depleter, and has shown significant potency in reducing clonal CD-19+ and CD-20+ B cells. Lantern believes that this mechanism can be redirected as a potential therapeutic for auto-immune disorders, including lupus nephritis. Lantern plans on sharing data from these early preclinical studies during Q2 of 2025.
RADR A.I. Platform
Lantern’s proprietary RADR platform surpassed 100 billion oncology-focused data points across multiple sources (proprietary and public) of oncology, molecular, clinical and preclinical datasets in 2024. Across Lantern’s pipeline RADR continues to advance:
● drug candidate optimization,
● development and validation of clinically relevant drug-candidate combinations,
● identification of mechanism(s) of action,
● identification of optimal indications for drug-candidate advancement, and
● creation of biomarker signatures to support patient selection
● optimization and characterization of molecular features
● prediction of BBB capabilities of a molecule
Platform advancements contributed to LP-184’s clinical biomarker strategy, including a qPCR assay for PTGR1 to guide patient stratification, and aided in the identification of multiple indications leading to orphan and rare pediatric disease designations. Additionally, RADR also underpinned combination strategies, such as LP-184 with anti PD1 checkpoint inhibitors and LP-284 with rituximab. Future plans and developments include additional collaborations with leading oncology development groups and biopharma companies in both adult and pediatric cancers.
Lantern expects to publicly release multiple modules (validated A.I. frameworks) that can be accessed by Lantern collaborators for specific needs in oncology drug development, such as prediction of certain molecular features and identification of potential cancer indications that are more likely to show a higher sensitivity to a molecule or drug-candidate.
Starlight Therapeutics:
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 successful additional funding. Additionally, Starlight appointed Dr. Marc Chamberlain as Chief Medical Officer and established its inaugural Scientific Advisory Board, which includes leading neuro-oncology researchers and clinicians during 2024.
Additional Operational Highlights:
Ø Advanced strategic RADR-based AI collaborations with Actuate Therapeutics (NASDAQ:ACTU) and Oregon Therapeutics, accelerating and refining the development of novel best-in-class cancer metabolism inhibitors.
Ø Achieved key development milestone in the creation of a qRT-PCR molecular diagnostic for PTGR1 assessment to identify patients most likely to respond to LP-184, potentially increasing success rates through precision patient selection for future clinical trials.
Ø Secured Japanese Patent Office protection for LP-284 composition of matter, extending IP coverage through 2039 in a strategic market with 7,000+ NHL cases annually.
Ø Advanced proprietary BBB permeability prediction algorithm with favorable PCT patent application report, advancing our AI leadership with Lantern’s algorithms holding five of the top ten positions on Therapeutic Data Commons Leaderboard.
Fourth Quarter and Full Year 2024 Financial Results:
Ø Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $24.0 million as of December 31, 2024, compared to approximately $41.3 million as of December 31, 2023.
Ø R&D Expenses: Research and development expenses were approximately $4.3 million for the quarter ended December 31, 2024, compared to approximately $3.6 million for the quarter ended December 31, 2023.
Ø G&A Expenses: General and administrative expenses were approximately $1.6 million for the quarter ended December 31, 2024, compared to approximately $1.3 million for the quarter ended December 31, 2023.
Ø Net Loss: Net loss was approximately $5.9 million (or $0.54 per share) for the quarter ended December 31, 2024, compared to a net loss of approximately $4.2 million (or $0.39 per share) for the quarter ended December 31, 2023.
Ø Full Year Net Loss Per Share: Net loss was $1.93 per share for the fiscal year 2024 compared to $1.47 per share for the fiscal year 2023.
Ø Shares Issued: In fiscal year 2024 the Company issued 21,313 shares of common stock for aggregate proceeds of $66,710, relating to the exercise of warrants that were expiring. The Company also issued 22,220 shares of common stock relating to the cashless exercise of warrants to purchase 86,685 shares during the year ended December 31, 2024. The Company also issued 20,000 shares of restricted common stock during fiscal year 2024.