On 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, reported 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 (Press release, Lantern Pharma, AUG 13, 2025, View Source [SID1234655199]).

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"This 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."

Clinical Pipeline Developments

LP-184: Successful Completion of Enrollment for Phase 1a & Advancing Toward Phase 1b/2 Studies

Lantern 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 bladder cancer.

LP-184 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.

During 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).

LP-184 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.

LP-300 HARMONIC Trial: Complete Response Observed Demonstrating Clinical Activity & Successful Completion of Enrollment in Japan

The 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.

Additionally 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.

The 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.

The 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.

LP-284: Phase 1a Clinical Trial in Refractory Lymphoma Observed a Complete Response

LP-284 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.

This 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 lymphomas.

The 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.

Intellectual Property Advancements

Lantern significantly strengthened its global intellectual property portfolio during the second quarter with two major patent developments:

European 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 partnerships.

Blood-Brain 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.

RADR AI Platform Enhancements

Lantern 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:

PredictBBB.ai 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.

Drug 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 inhibitors combinations in cancer: a data-driven review".

The company plans to make select RADR modules available to the broader scientific and research community, fostering collaborative, open-source innovation in oncology drug development while creating potential new revenue streams.

Financial Results for Second Quarter 2025

Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $15.9 million as of June 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 as of June 30, 2025 and anticipated expenditures will enable funding of operating expenses and capital expenditure requirements at least into June 2026.

Research and Development Expenses: R&D expenses were approximately $3.1 million for the quarter ended June 30, 2025, compared to approximately $3.9 million for the quarter ended June 30, 2024, reflecting continued disciplined cost management while advancing multiple clinical programs.

General and Administrative Expenses: G&A expenses were approximately $1.6 million for the quarter ended June 30, 2025, compared to approximately $1.5 million for the quarter ended June 30, 2024.

Net Loss: Net loss was approximately $4.33 million (or $0.40 per share) for the quarter ended June 30, 2025, compared to a net loss of approximately $4.96 million (or $0.46 per share) for the quarter ended June 30, 2024.

Capitalization: As of June 30, 2025, the Company had 10,784,725 shares of common stock outstanding, and options to purchase 1,239,766 shares of common stock at a weighted average exercise price of $5.72 per share were outstanding. There were no outstanding warrants as of June 30, 2025.

Quarterly Earnings Calls:

Lantern has determined not to host a quarterly earnings call at the present time given the concentration of resources required for a live video based webinar style call. In addition to quarterly press releases with earnings information, and more frequent updates regarding the progress of our portfolio and platform, we plan to focus our resources on other distribution channels that we believe will be more effective in conveying information to stockholders, including webinars, digital media resources and broader social media channels.