Full Press Release Details
Pharma Reports Third Quarter 2025 Financial Results and Provides Business Updates
Quarter Marked by Clinical Validation, Regulatory Progress, and Strategic Momentum in Commercial AI Platform Launch
| LP-184 Phase 1a clinical trial results demonstrate all primary endpoints achieved with 48% clinical benefit rate in evaluable cancer patients at or above therapeutic dose threshold; marked tumor reductions observed in patients with DNA damage repair mutations including CHK2, ATM, and STK11/KEAP1 alterations. | ||
| FDA Type C meeting completed , providing regulatory guidance and pathway clarity for Starlight Therapeutics' planned pediatric CNS cancer trial in Atypical Teratoid Rhabdoid Tumor (ATRT) and confirming spironolactone combination strategy. | ||
| LP-300 preliminary Phase 2 data presented from the HARMONIC trial at the 66th Annual Meeting of the Japan Lung Cancer Society with further clinical and patient data planned for a webinar in December. | ||
| LP-284 clinical data showcased at 25th Annual Lymphoma, Leukemia & Myeloma (LL&M) Congress , generating interest from the biopharma and clinical communities and initiating discussions for combination therapy potential. | ||
| KOL-hosted scientific webinar on LP-184 Phase 1a results scheduled for November 20, 2025 at 4:30 p.m. ET , providing insights from key opinion leader at Fox Chase Cancer Center along with additional clinical data and future plans from Lantern management. | ||
| Precision, biomarker-driven development strategy strengthened by Phase1a data, positioning LP-184 for targeted Phase 1b/2 trials in TNBC, NSCLC with KEAP1/STK11 mutations, bladder cancer, and first recurrent GBM-indications representing combined market potential exceeding $7 billion annually. | ||
| AI platform commercial readiness demonstrated at inaugural AI for Biology and Medicine symposium, showcasing RADR platform modules as deployable tools for biopharma partners. | ||
| Disciplined capital management maintained with approximately $12.4 million in cash, cash equivalents, and marketable securities as of September 30, 2025, providing expected operating runway into approximately Q3 2026. | ||
| Conference call and webcast scheduled for Thursday, November 13, 2025 at 9:00 a.m. ET. |
WIRE)- November 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 third quarter
2025 ended September 30, 2025, and provided an update on its portfolio of AI-driven drug candidates and AI platform, RADR .
third quarter represented a transformational period for Lantern Pharma as we announced successful enrollment completion of our LP-184
Phase 1a trial, achieving all primary endpoints with unique clinical benefit observations in multiple hard-to-treat solid tumors,"
said Panna Sharma, CEO & President of Lantern Pharma. "The observed 48% clinical benefit rate at or above the therapeutic
dose threshold, combined with the favorable safety profile and clear biomarker signals, validates our AI-driven, precision medicine approach
and positions us to advance multiple planned high-value Phase 1b/2 trials. Simultaneously, our productive FDA Type C meeting provides
a clear regulatory pathway for our pediatric CNS cancer program under our subsidiary Starlight Therapeutics. Additionally, the
interest generated for LP-284 at the LL&M Congress underscores the commercial potential across our pipeline. We are executing
with discipline and focus as we advance toward pivotal value-creation milestones in multiple oncology indications."
Pipeline Developments
Detailed Phase 1a Results Demonstrate Clinical Proof-of-Concept & Activity
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 critical insights into safety, pharmacokinetics,
biomarker correlations, and clinical activity that position LP-184 for advancement into targeted planned Phase 1b/2 studies.
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 encouraging 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 Supports Broad Development: 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, providing clear dosing guidance for planned Phase 1b/2 studies across multiple indications. |
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 significant unmet medical need and 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. |
results from the LP-184 Phase 1a trial are being prepared for submission to peer-reviewed journals and presentation at major oncology
conferences. To provide additional insights and expert analysis of the clinical data, Lantern will host a Key Opinion Leader (KOL)-hosted
scientific webinar on November 20, 2025 at 4:30 p.m. Eastern Time featuring detailed discussion of the Phase 1a results, biomarker
findings, and clinical development strategy.
Type C Meeting: Clarity in Regulatory Path for Pediatric CNS Cancer Program
major third quarter regulatory milestone was the successful completion of a Type C meeting with the U.S. Food and Drug Administration
during September. This meeting provided important 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). The FDA provided constructive and supportive feedback on the proposed clinical trial structure.
outcomes from the Type C meeting included:
| Parallel ATRT Cohort Supported: The FDA confirmed support for a parallel cohort design specifically for ATRT patients, which will accelerate data collection in this ultra-rare pediatric population while maintaining statistical rigor. | ||
| Combination Strategy Confirmed: The agency confirmed the potential incorporation of spironolactone as a combination agent with LP-184/STAR-001. This combination strategy is based on preclinical data demonstrating synergistic activity and RADR platform predictions of enhanced efficacy in pediatric brain tumors. | ||
| Trial Design Alignment: The FDA provided guidance on appropriate endpoints, patient selection criteria, and safety monitoring approaches for this vulnerable pediatric population, enabling Starlight Therapeutics to finalize the clinical protocol with confidence in the regulatory pathway. |
Designations and Market Opportunity:
| 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. These designations underscore the urgent unmet need for innovative therapies in aggressive pediatric cancers and provide potential pathways for possible priority review vouchers upon approval. | ||
| ATRT is an ultra-rare pediatric brain tumor with the genetic hallmark of SMARCB1 gene loss or dysfunction, affecting primarily children under age 3. Current treatment options are limited and associated with significant long-term toxicities, creating substantial demand for novel targeted approaches. |
HARMONIC Trial: Enrollment and Follow-Up Progress
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 in Japan, including the National Cancer Center Tokyo. | ||
| During 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 . Dr. Jonathan Dowell from UT Southwestern Medical Center presented, " A Phase II Trial of LP-300 plus Carboplatin and Pemetrexed in TKI-Progressed NSCLC Patients ". Data from this presentation included the Asian and US cohorts of the study and will be further reviewed and presented in December by Lantern Pharma. |
| Also, during the third quarter the company progressed with a change in clinical staffing and a transition of CRO services in Asia focused on significant cost reductions and efficiency in Taiwan. | ||
| The study's strategic positioning in Asia, where never-smokers represent 33-40% of NSCLC cases compared to approximately 15% in Western populations, positions Lantern for potential regional partnerships and co-development opportunities. The treatment of never-smokers with NSCLC represents an estimated $4+ billion annual market opportunity with no specifically approved therapies for this patient population. |
LL&M Congress Presentation & Future Development Plans
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.
Congress Impact and Additional Milestones:
| Presentation generated interest from biopharmaceutical companies and clinical investigators , with ongoing discussions focused on: combination therapy development with FDA-approved agents; post-immunotherapy treatment strategies; and LP-284's mechanistic differentiation. LP-284 has demonstrated particular lethality in cells with deficient DNA damage response, a targetable vulnerability in NHL. | ||
| 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. |
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 including for mantle
cell lymphoma and high-grade B-cell lymphomas.
AI Platform: Demonstrating Commercial Value and Industry Leadership
for Biology and Medicine Symposium: Showcasing Platform Capabilities
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. An additional large-scale rollout of a multi-agentic system focused on addressing drug development and research needs
in rare cancers that leverages Lantern's unique approach to developing therapies and approaches in rare and orphan cancers is underway.
This initiative is planned to be made public during December with broader industry rollout in early 2026.
Platform - Best-in-Class BBB Prediction:
| 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, establishing clear technological leadership. | ||
| The platform addresses a critical pharmaceutical challenge: only 2-6% of small-molecule drugs successfully cross the blood-brain barrier. The BBB technologies market is projected to grow from $1.4 billion in 2023 to $9.85 billion by 2032, representing significant commercial opportunity. |
Liquid Biopsy Platform - Predictive Biomarker Discovery:
| 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. This capability enables non-invasive patient stratification and real-time treatment monitoring. | ||
| Lantern has entered into additional collaborations with leading research and cancer centers to further strengthen and validate this module in other cancers. |
Platform Impact Across Pipeline
third quarter developments underscore RADR 's central role in Lantern's drug development success:
| Biomarker Discovery: RADR predictions of LP-184 sensitivity in CHK2, ATM, and STK11/KEAP1-mutated cancers were validated in the Phase 1a trial, demonstrating the platform's promise for identifying responsive patient populations. | ||
| Combination Therapy Identification: RADR analysis identified LP-184's synergy with PARP inhibitors and immunotherapy, as well as LP-284's synergy with rituximab, directly informing clinical development strategies and partnership discussions. |
Results for Third Quarter 2025
Sheet: 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.
and Development Expenses: 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. The decrease was primarily attributable to decreases in research
studies and materials of approximately $1,032,000 relating to the conduct and support of clinical trials, decreases in consulting expenses
of approximately $55,000 and decreases in payroll and compensation expenses of approximately $224,000. This was partially offset by increases
in licensing expenses of approximately $31,000.
and Administrative Expenses: 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. The increase was primarily attributable to increases in business
development and investor relations expenditures of approximately $321,000, increases in other professional fees of approximately $57,000,
and increases in patent costs of approximately $37,000.
Loss: 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. Options to purchase approximately
1.2 million shares of common stock at a weighted average exercise price of $5.74 per share were outstanding. As of September 30, 2025
there were no warrants outstanding.
July 2025, the Company entered into an ATM Sales Agreement ("ATM"), with ThinkEquity LLC ("ThinkEquity"), as
sales agent, pursuant to which the Company may offer and sell up to $15,530,000 of its common stock from time to time, in "at-the-market"
offerings to or through its sales agent. During the quarter ended September 30, 2025, we 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, we have sold an additional 144,204
shares of common stock under the ATM for the gross proceeds of $634,333.
Milestones and Corporate Developments
ahead to the fourth quarter of 2025 and early 2026, Lantern expects several key value-creation catalysts:
Near-Term (Q4 2025):
| 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 | ||
| Scale up of AI platform commercial efforts | ||
| Preparation for potential capital formation activities to support clinical advancement |
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.
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.