Full Press Release Details
Pharma Reports Second Quarter 2025 Financial Results and Business Updates
milestone achieved with successful completion of enrollment for LP-184 Phase 1a clinical trial, with 65 patients enrolled across
a range of solid tumors including glioblastoma (GBM); LP-184 is a potential blockbuster drug-candidate with market potential of $10-12
billion USD in annual revenue.
tolerated dose (MTD) and recommended Phase 2 dose (RP2D) established for LP-184, enabling advancement to upcoming Phase 1b/2 trials
being planned for recurrent triple negative breast cancer (TNBC) and recurrent bladder cancer.
complete response observed in HARMONIC Trial patient: A 70-year-old never-smoker with advanced non-small cell lung cancer
(NSCLC) demonstrated a complete response in target cancer lesions following treatment with LP-300 in combination with chemotherapy; the
patient had previously failed three prior lines of therapy including tyrosine kinase inhibitors and immunotherapy.
data and clinical findings from the HARMONIC Phase 2 trial anticipated in September 2025, including initial response and safety
evaluations for patients from the Asian expansion cohort enrolled across sites in Japan and Taiwan.
achieves complete metabolic response in therapeutically exhausted patient: A 41-year-old patient with aggressive diffuse large B-cell
lymphoma (DLBCL) who had previously failed R-CHOP chemotherapy, CAR-T therapy, and bispecific antibody therapy achieved complete metabolic
response after just two cycles of LP-284.
module launched: A proprietary algorithm and machine learning solution for determining the blood brain barrier penetrability of any
molecule has been launched publicly as a RADR module with best-in-class predictive capabilities to support CNS drug development.
platform enhanced with AI-powered drug combination prediction module: New framework and analytics capabilities based on peer-reviewed
research to improve prediction of synergistic cancer drug combinations, with initial focus on DNA damaging agents and DNA repair inhibitors.
Lantern Pharma Q2 Financial Results & Business Highlights
capital management maintained with approximately $15.9 million in cash, cash equivalents, and marketable securities as of June 30,
2025, providing expected operating runway at least into June 2026.
WIRE)- August 13, 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, today announced operational highlights and financial results for the second quarter 2025 ended June 30, 2025,
and provided an update on its portfolio of AI-driven drug candidates and AI platform, RADR .
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. Simultaneously, our team is transforming our AI platform into functional, accessible modules for the broader oncology
community. These parallel advances mark a pivotal inflection point in our clinical and technological evolution, reinforcing our fiscally
disciplined, AI-driven approach to addressing critical unmet patient needs with a clear pathway to commercialization and value creation."
Pipeline Developments
Successful Completion of Enrollment for Phase 1a & Advancing Toward Phase 1b/2 Studies
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 of
planned Phase 1b/2 studies in indications with large multi-billion dollar annual market potential, including recurrent TNBC and recurrent
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 for hepatoblastoma, rhabdomyosarcoma, malignant rhabdoid tumors, and atypical teratoid
rhabdoid tumors (ATRT). Through its wholly-owned subsidiary Starlight Therapeutics, Lantern is developing LP-184 as STAR-001 for central
nervous system cancers.
Lantern Pharma Q2 Financial Results & Business Highlights
the quarter, Lantern announced findings from independent research conducted at Johns Hopkins validating Lantern's data used to
secure the FDA Rare Pediatric Disease Designation for LP-184 in ATRT and support planned pediatric clinical trials. The data demonstrated
that LP-184, a next-generation acylfulvene clinical-stage drug candidate, significantly extended survival in mouse models of 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). In the BT37 model, median survival increased from 68 days to 98 days (p=0.0422).
is a next-generation acylfulvene drug candidate, a synthetic small molecule belonging to a class of naturally-derived anti-cancer agents.
LP-184 works by preferentially damaging DNA in cancer cells that overexpress specific biomarkers or that harbor mutations in DNA damage
repair pathways. LP-184 is the product of years of research, including insights from RADR , Lantern's proprietary
AI platform that leverages over 200 billion oncology-focused data points. LP-184 is a prodrug that is converted to its bioactive form
inside the cancer cell by PTGR1 (prostaglandin reductase 1), an enzyme that is overexpressed in certain cancers. Once activated, LP-184
creates cytotoxic metabolites that form adducts with DNA, leading to irreparable DNA damage and ultimately tumor cell death.
HARMONIC Trial: Complete Response Observed Demonstrating Clinical Activity & Successful Completion of Enrollment in Japan
Phase 2 HARMONIC trial continues to advance with enrollment across the United States and expansion sites in Asia. A remarkable
complete response was observed in a 70-year-old never-smoker patient with advanced NSCLC who had exhausted three prior treatment regimens.
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.
the Phase 2 HARMONIC trial made advancements in Asia with completion of the Japanese cohort of 10 patients. Multiple centers in
Japan participated in the clinical trial including The National Cancer Center Tokyo.
study is strategically positioned in regions with high prevalence of never-smoker lung cancer patients, 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.
treatment of never-smokers with NSCLC represents a market opportunity estimated at over $4 billion annually. There are no approved therapies
specifically targeted at the treatment of never-smokers with NSCLC currently. Lantern is actively exploring collaboration and partnering
opportunities to maximize LP-300's commercial potential in multiple geographies.
Lantern Pharma Q2 Financial Results & Business Highlights
Phase 1a Clinical Trial in Refractory Lymphoma Observed a Complete Response
exhibited remarkable clinical activity in a heavily pretreated 41-year-old patient with aggressive Grade 3 diffuse large B-cell lymphoma
(DLBCL). Following failure of standard R-CHOP/Pola-R-CHP chemotherapy, CAR-T cell therapy (liso-cel), and CD3xCD20 bispecific antibody
therapy (glofitamab), the patient achieved complete metabolic response with non-avid lesions after completing just two doses of LP-284.
represents the first complete response observed with LP-284. The complete response provides support to the mechanistic rationale and
the potential for further future clinical activity in one of the most therapeutically challenging hematological malignancies. Lantern
believes that this supports LP-284's synthetic lethal mechanism and potential paradigm-shifting role in treating refractory aggressive
complete metabolic response achievement positions LP-284 to seek a future role within a global blood cancer market focused on B-cell
cancer that is estimated at $4 billion annually, with DLBCL representing the largest aggressive lymphoma subtype affecting approximately
200,000 patients globally each year. The critical unmet need in refractory/relapsed settings represents a substantial commercial opportunity
for innovative therapeutic approaches that can deliver meaningful clinical benefit to therapeutically exhausted patient populations.
Property Advancements
significantly strengthened its global intellectual property portfolio during the second quarter with two major patent developments:
Patent Allowance for LP-284: The European Patent Office (EPO) issued a notice of allowance for a composition of matter patent covering
LP-284, expected to be granted with exclusivity through early 2039. This EU patent complements existing composition of matter patents
granted in the U.S. (April 2023) and Japan (June 2024), with additional patent allowances in India and Mexico, and applications pending
in China, Australia, Canada, and Korea. This expanding international IP portfolio positions LP-284 for global commercialization and strategic
Barrier Prediction Patent Application: Lantern announced the publication of its PCT patent application (PCT/US2024/019851) covering a
novel machine learning solution for predicting blood-brain barrier (BBB) permeability, which received a favorable PCT search report indicating
no significant prior art. The technology powering predictBBB demonstrates exceptional performance, processing up to 100,000 molecules
per hour with industry-leading accuracy. Lantern's AI algorithms currently hold five of the top eleven positions on the Therapeutic
Data Commons Leaderboard. The PCT application, if granted, will enable multi-country patent protection for 20 years from the filing date.
Lantern Pharma Q2 Financial Results & Business Highlights
AI Platform Enhancements
continues to expand the capabilities of its RADR platform, which now leverages over 200 billion oncology-focused data
points and a library of 200+ advanced machine learning algorithms. Key enhancements this quarter include:
Module Public Launch: The public release of predictBBB.ai , an AI module for predicting blood-brain barrier permeability with 94%
prediction accuracy, 95% sensitivity and 89% specificity. This addresses a critical pharmaceutical development challenge where only 2-6%
of small-molecule drugs can successfully cross the blood-brain barrier.
Combination Prediction Module: An innovative AI-powered module to improve prediction of synergistic cancer drug combinations, with framework
and analytics based on peer-reviewed research. The module focuses initially on DNA damaging agents and DNA repair inhibitors, aimed at
a market opportunity where approximately $50 billion is spent annually on the development of combination therapies for cancer. The AI
module, trained on 221 clinical trials, will be incorporated as part of Lantern's AI platform, RADR , and will initially focus
on tailored combinations of DNA damaging agents and DNA repair inhibitors. The framework and foundational data for the module was published
in a peer-reviewed study published in Frontiers in Oncology, "Clinical outcomes of DNA-damaging agents and DNA damage response