November 13, 2025 — Leads & Copy — Lantern Pharma Inc., a clinical-stage biopharmaceutical company utilizing its RADR® artificial intelligence (AI) and machine learning (ML) platform, has announced operational highlights and financial results for the third quarter 2025, which ended September 30, 2025. The company also provided an update on its AI-driven drug candidates and RADR® AI platform.
Panna Sharma, CEO & President of Lantern Pharma, stated that the third quarter was transformational for the company. Enrollment was completed in the LP-184 Phase 1a trial, achieving all primary endpoints with clinical benefit observations in multiple hard-to-treat solid tumors. Sharma noted the 48% clinical benefit rate at or above the therapeutic dose threshold, combined with a favorable safety profile and clear biomarker signals, validates the company’s AI-driven, precision medicine approach.
Sharma added that a productive FDA Type C meeting provides a clear regulatory pathway for the pediatric CNS cancer program under its subsidiary Starlight Therapeutics, and the interest generated for LP-284 at the LL&M Congress underscores the commercial potential across the pipeline. He said the company is focused on advancing toward pivotal value-creation milestones in multiple oncology indications.
Clinical Pipeline Developments
In September, Lantern announced the completion of enrollment and initial clinical results from its LP-184 Phase 1a clinical trial (NCT05933265), which successfully achieved all primary endpoints. The data across the 63 patients enrolled provided insights into safety, pharmacokinetics, biomarker correlations, and clinical activity that position LP-184 for advancement into targeted planned Phase 1b/2 studies.
Highlights of the Phase 1a Results:
- Clinical Benefit and Activity: The trial demonstrated clinical benefit in 48% of evaluable cancer patients treated at or above the therapeutic dose threshold. This activity was observed in heavily pretreated patients who had exhausted available standard-of-care therapies, representing proof-of-concept for LP-184’s synthetic lethal mechanism.
- Safety Profile: LP-184 demonstrated a favorable safety and tolerability profile with minimal dose-limiting toxicities. The safety data support advancement into both monotherapy and combination therapy approaches with PARP inhibitors and immunotherapy agents.
- Activity in Difficult-to-Treat Cancers: Notable clinical benefits were observed in historically challenging tumor types including glioblastoma multiforme (GBM), gastrointestinal stromal tumor (GIST), and thymic carcinoma. Several patients have continued treatment beyond enrollment completion due to ongoing clinical benefit.
- Biomarker Strategy Strengthened: A key finding from the Phase 1a trial was the observation of marked tumor reductions in patients harboring specific DNA damage repair mutations, including CHK2, ATM, BRCA1, and STK11/KEAP1 alterations. These biomarker insights directly validate the AI-driven patient stratification approach developed through Lantern’s RADR® platform and support the use of genomic selection criteria in future trials.
- Pharmacokinetics Enable Dose Optimization: The trial successfully characterized LP-184’s pharmacokinetic profile and established the recommended Phase 2 dose (RP2D) of 0.39 mg/kg.
Based on the Phase 1a results and biomarker insights, Lantern is advancing development plans for LP-184 in three high-value indications:
- Triple-Negative Breast Cancer (TNBC), which represents a potential annual market opportunity exceeding $4 billion.
- NSCLC with STK11/KEAP1 Co-mutations: Phase 1b/2 study in a biomarker-defined subset of patients with mutations in STK11 and/or KEAP1 genes, representing a potential annual market approaching $1.5 billion.
- Bladder Cancer with DNA damage repair mutations in patients who have relapsed from SOC (standard of care) therapies, which is planned to be an investigator-led study initiating in Denmark.
Comprehensive results from the LP-184 Phase 1a trial are being prepared for submission to peer-reviewed journals and presentation at major oncology conferences. Lantern will host a Key Opinion Leader (KOL)-hosted scientific webinar on November 20, 2025 at 4:30 p.m. Eastern Time.
FDA Type C Meeting
In September, Lantern completed a Type C meeting with the U.S. Food and Drug Administration. This meeting provided guidance on the regulatory pathway and trial design for Starlight Therapeutics’ – a wholly owned subsidiary of Lantern Pharma – planned pediatric clinical trial focused on CNS cancers, including Atypical Teratoid Rhabdoid Tumor (ATRT).
Key outcomes from the Type C meeting included:
- The FDA confirmed support for a parallel cohort design specifically for ATRT patients.
- The agency confirmed the potential incorporation of spironolactone as a combination agent with LP-184/STAR-001.
- The FDA provided guidance on appropriate endpoints, patient selection criteria, and safety monitoring approaches for this vulnerable pediatric population.
LP-184, which is being developed as STAR-001 by Starlight Therapeutics in CNS cancers, has received both Rare Pediatric Disease Designation and Orphan Drug Designation from the FDA for ATRT, along with additional Rare Pediatric Disease Designations for hepatoblastoma, rhabdomyosarcoma, and malignant rhabdoid tumors.
LP-300 HARMONIC™ Trial
The Phase 2 HARMONIC™ trial continued patient enrollment and follow-up during the third quarter across sites in the United States, Japan, and Taiwan. The trial evaluates LP-300 in combination with standard-of-care chemotherapy (carboplatin + pemetrexed) in never-smokers with NSCLC adenocarcinoma who have progressed after tyrosine kinase inhibitor therapy.
In late July, Lantern announced the completion of enrollment in Japan for the HARMONIC™ trial across five clinical sites, including the National Cancer Center Tokyo.
In November, clinical investigators associated with the HARMONIC™ trial presented data from the ongoing study at the 66th Annual Meeting of the Japan Lung Cancer Society.
During the third quarter, the company progressed with a change in clinical staffing and a transition of CRO services in Asia focused on cost reductions and efficiency in Taiwan.
LP-284: LL&M Congress Presentation
In October Lantern presented clinical data from its ongoing LP-284 Phase 1 trial at the 25th Annual Lymphoma, Leukemia & Myeloma (LL&M) Congress in New York City. The presentation showcased the confirmed complete metabolic response in a heavily pretreated DLBCL patient and highlighted LP-284’s novel mechanism of action and combination therapy potential.
LL&M Congress Impact and Additional Milestones:
- Presentation generated interest from biopharmaceutical companies and clinical investigators
- Additional clinical sites being recruited with a focus on NHL and high-grade B-cell lymphoma patients to accelerate enrollment.
- Partnership and collaboration discussions advancing with emphasis on combination therapy protocols.
- Expansion into autoimmune and inflammatory indications under preclinical evaluation, leveraging LP-284’s B-cell depletion activity.
LP-284 benefits from strong intellectual property protection with composition of matter patents granted in the U.S., Europe, Japan, India, and Mexico, providing exclusivity through 2039. The drug candidate has received multiple FDA Orphan Drug Designations.
RADR® AI Platform
A key highlight of the third quarter was Lantern’s presentation at the inaugural AI for Biology and Medicine symposium at the University of North Texas on October 30, 2025. This presentation demonstrated the commercial readiness and real-world applicability of two RADR® platform modules.
predictBBB.ai Platform
This ensemble machine learning model achieves 94.1% accuracy for blood-brain barrier permeability prediction and can screen 200,000 molecular candidates in under one week. Lantern’s algorithms currently hold five of the top eleven positions on the Therapeutic Data Commons Leaderboard. The BBB technologies market is projected to grow from $1.4 billion in 2023 to $9.85 billion by 2032.
LBx-AI Liquid Biopsy Platform
This AI-powered liquid biopsy analysis platform has achieved 86% accuracy for predicting treatment response in non-small cell lung cancer and has demonstrated a 0.76 Pearson correlation for PD-L1 level inference from circulating tumor DNA analysis. Lantern has entered into additional collaborations with leading research and cancer centers.
Third quarter developments underscore RADR®’s central role in Lantern’s drug development success:
- RADR® predictions of LP-184 sensitivity in CHK2, ATM, and STK11/KEAP1-mutated cancers were validated in the Phase 1a trial.
- RADR® analysis identified LP-184’s synergy with PARP inhibitors and immunotherapy, as well as LP-284’s synergy with rituximab.
- Lantern’s AI-guided drug programs have advanced from initial insights to first-in-human trials in 2-3 years at approximately $1.0-2.5 million per program.
Financial Results for Third Quarter 2025
- Cash, cash equivalents, and marketable securities were approximately $12.4 million as of September 30, 2025, compared to approximately $24.0 million as of December 31, 2024. The company believes that its existing cash, cash equivalents, and marketable securities on hand as of the date of this press release will enable it to fund anticipated operating expenses and capital expenditure requirements into approximately Q3 2026.
- R&D expenses were approximately $2.4 million for the quarter ended September 30, 2025, compared to approximately $3.7 million for the quarter ended September 30, 2024.
- G&A expenses were approximately $1.9 million for the quarter ended September 30, 2025, compared to approximately $1.5 million for the quarter ended September 30, 2024.
- Net loss was approximately $4.2 million (or $0.39 per share) for the quarter ended September 30, 2025, compared to a net loss of approximately $4.5 million (or $0.42 per share) for the quarter ended September 30, 2024.
- As of September 30, 2025, the Company had approximately 11.0 million shares of common stock outstanding.
During the quarter ended September 30, 2025, the company sold 212,444 shares of common stock under the ATM for the gross proceeds of $989,061. Between October 1, 2025 and the date of this press release, the company sold an additional 144,204 shares of common stock under the ATM for the gross proceeds of $634,333.
Upcoming Milestones and Corporate Developments
Looking ahead to the fourth quarter of 2025 and early 2026, Lantern expects several key value-creation catalysts:
- November 20, 2025 at 4:30 p.m. ET: KOL hosted scientific webinar on LP-184 Phase 1a detailed results and clinical development strategy.
- December 2025: LP-300 further patient follow-up and clinical data.
- Q4 2025: Continued commercial developments for AI platform modules, including the multi-agentic system for rare cancer drug development.
- Q1 2026: Planned Pediatric CNS cancer trial initiation through Starlight Therapeutics subsidiary (IND amendment submission)
- Q1 2026: Planned initiation of LP-184 Phase 1b/2 trials in TNBC and NSCLC (subject to funding)
- H1 2026: Investigator-led bladder cancer trial initiation in Denmark
- 2026: Additional HARMONIC™ trial data readouts and potential partnership announcements
Lantern Pharma will host a conference call and webcast to discuss third quarter 2025 financial results and business updates on Thursday, November 13, 2025 at 9:00 a.m. Eastern Time.
To participate in the conference call, please register at the Zoom webcast link. A replay of the earnings call webcast will be available after the call on the investor relations section of Lantern’s website at ir.lanternpharma.com.
Please register at the Zoom webcast link for the scientific webinar featuring key opinion leader analysis of the LP-184 Phase 1a results on November 20, 2025 at 4:30 p.m. Eastern Time.
Source: Lantern Pharma
