Year of Clinical Validation and Strategic Expansion Across Pipeline, AI Platform Advances Towards Commercialization, and Global Trial Milestones
- LP-300 Phase 2 HARMONIC™ Trial Progress: Continued enrollment and patient follow-up across
the United States ,Japan , andTaiwan . Completion of targeted enrollment inJapan across five clinical sites including the National Cancer Center Tokyo. Preliminary data presented at the 66th Annual Meeting of theJapan Lung Cancer Society . Type C meeting package submitted to FDA inMarch 2026 , with meeting scheduled formid-May 2026 seeking feedback on proposed protocol amendments including focusing enrollment on EGFR exon 21 L858R patients and updating the LP-300 dosing schedule to allow for up to 8 cycles of treatment. The treatment of never-smokers with NSCLC represents an estimated $4+ billion annual market opportunity with no specifically approved therapies. - LP-184 Phase 1a Completion and Expansion: All primary endpoints achieved with 48% clinical benefit rate at or above therapeutic dose threshold; additional positive results reported in Q4 2025 demonstrating durable disease control in heavily pre-treated advanced cancer patients. Biomarker-guided Phase 1b/2 trials planned in TNBC, NSCLC with KEAP1/STK11 mutations, and an investigator-led clinical study in
Denmark in PTGR1 overexpressing bladder cancers with DNA damage repair mutations. - Starlight Therapeutics IND Clearance: FDA clears IND for planned Phase 1 pediatric CNS cancer trial of STAR-001 in Atypical Teratoid Rhabdoid Tumor (ATRT) and other rare pediatric cancers, marking a pivotal regulatory milestone for Lantern’s wholly-owned subsidiary.
- LP-284 Orphan Drug Designation: LP-284 receives FDA Orphan Drug Designation for soft tissue sarcomas, adding to existing designations for mantle cell lymphoma and high-grade B-cell lymphomas. Complete metabolic response in therapeutically exhausted DLBCL patient presented at 25th
LL&M Congress . - AI-Driven Pipeline: Lantern’s portfolio of clinical-stage drug candidates, spanning lung cancer, breast cancer, lymphoma, sarcoma, pediatric brain cancers, and bladder cancer, represents a combined estimated annual market potential exceeding
$15 billion , with multiple programs positioned to advance towards Phase 1b/2 and Phase 2 value-creation milestones in 2026. - RADR® AI Platform Global Expansion: Initiation of
AI Center of Excellence inIndia to industrialize the RADR® platform and accelerate global biopharma development opportunities. Presentation at 7th Glioblastoma Drug Development Summit inBoston . - withZeta.ai — Multi-Agentic Co-Scientist Platform: Introduction of withZeta.ai, a first-of-its-kind multi-agentic AI co-scientist platform designed to accelerate drug development insights and therapeutic strategies across more than 438 rare cancers. Since late
December 2025 , withZeta.ai has been in active demo and beta testing with over 25 biotech companies, cancer research centers, and biopharma consultants, representing a significant near-term commercialization opportunity for the Company’s AI capabilities. - Financial Position: Approximately
$10.1 million in cash, cash equivalents, and marketable securities as ofDecember 31, 2025 . - Conference call and webcast scheduled for
Monday, March 30, 2026 at4:30 p.m. ET .
“2025 was a defining year for
Clinical Pipeline Developments
Lantern’s AI-driven clinical pipeline encompasses multiple drug candidates across solid tumors, blood cancers, and pediatric oncology, with a combined estimated annual market potential exceeding
LP-300 HARMONIC™ Trial: Continued Progress and Strategic Momentum
The Phase 2 HARMONIC™ trial continued to advance through the fourth quarter and into early 2026, with ongoing patient enrollment and follow-up across clinical sites in
Key Milestones:
- Japan Enrollment Completed: In
July 2025 , Lantern completed targeted enrollment inJapan ahead of schedule across five clinical sites including the National Cancer Center Tokyo, validating the company’s strategic expansion into regions with significantly higher rates of never-smoker NSCLC. - Data Presented at JLCS: During Q4 2025, clinical investigators presented data from the ongoing HARMONIC™ trial at the 66th Annual Meeting of the
Japan Lung Cancer Society , including results from both Asian andU.S. patient cohorts. - Safety Lead-In Results: The trial has previously demonstrated encouraging results in its initial safety lead-in cohort, showing an 86% clinical benefit rate and 43% objective response rate among the first seven patients enrolled in
the United States , including one patient who achieved a durable complete response in target cancer lesions with survival continuing for nearly two years. - Enrollment Progress: The trial continues to enroll patients in
Taiwan , where more than 50% of lung cancer cases occur in never-smokers, and acrossU.S. sites. - FDA Engagement — Type C Meeting: In
March 2026 , Lantern submitted a Type C meeting package to the FDA regarding the ongoing Phase 2 HARMONIC™ study. The meeting, currently scheduled formid-May 2026 , seeks FDA feedback and concurrence on proposed protocol amendments to the study.
The proposed amendments to the HARMONIC™ study include: (i) focusing future enrollment to patients with EGFR exon 21 L858R mutation (a subtype of tyrosine kinase mutations); (ii) increasing the maximum number of LP-300 treatment cycles from six to eight; and (iii) converting the current randomized study design to a Phase 2 single-arm Simon two-stage study by discontinuing enrollment into the control arm. The proposed amendments are supported by a preliminary analysis of study data suggesting that patients with the EGFR exon 21 L858R mutation may derive greater clinical benefit from the LP-300 triplet regimen; the evolution of the treatment landscape for TKI-refractory NSCLC that has made continued randomization to the control arm increasingly challenging; and historical safety data indicating that up to eight cycles of LP-300 at the current dose level did not alter the established safety profile of the drug. There can be no assurance that the FDA will concur with the proposed amendments, and any changes to the study protocol will be subject to FDA review and clearance during and after the Type C meeting planned for mid-May.
Lantern is actively exploring collaboration and partnering opportunities both globally and regionally to maximize LP-300’s commercial potential in multiple geographies. Additional clinical data updates from the HARMONIC™ trial are expected in the first half of 2026.
Never-smoker NSCLC is increasingly recognized as a distinct disease entity with unique clinical and genomic characteristics, representing a global market opportunity estimated at over
LP-184: Phase 1a Completion and Advancement Toward Phase 1b/2 Trials
In Q4 2025, Lantern reported additional positive LP-184 Phase 1a results showing durable disease control in heavily pre-treated advanced cancer patients as the company is positioning to advance its precision oncology program into multiple biomarker-guided Phase 1b/2 trials. The Phase 1a trial (NCT05933265), which enrolled 63 patients, achieved all primary endpoints with a 48% clinical benefit rate at or above the therapeutic dose threshold and provided further confirmation of LP-184’s unique mechanism of action.
Key Phase 1a Highlights:
- Biomarker Validation: Marked tumor reductions observed in patients with DNA damage repair mutations including CHK2, ATM, BRCA1, and STK11/KEAP1 alterations, validating RADR®-driven insights regarding the mechanism of LP-184.
- Recommended Phase 2 Dose: Successfully established RP2D of 0.39mg/kg with favorable safety profile.
- Activity in Difficult-to-Treat Cancers: Notable clinical benefits in glioblastoma multiforme (GBM), gastrointestinal stromal tumor (GIST), and thymic carcinoma.
Phase 1b/2 Development Plans (subject to additional funding):
- Triple-Negative Breast Cancer (TNBC): Phase 1b/2 study targeting a potential annual market exceeding
$4 billion . - NSCLC with STK11/KEAP1 Co-mutations: Biomarker-guided study, potential annual market approaching
$1.5 billion .
Investigator Led Study:
- Bladder Cancer: Investigator-led clinical study planned to initiate in
Denmark in PTGR1 overexpressing bladder cancers with DNA damage repair mutations.
Starlight Therapeutics: FDA IND Clearance for Pediatric CNS Cancer Trial
In early 2026, the FDA cleared the IND for Starlight Therapeutics’ planned Phase 1 pediatric CNS cancer trial of STAR-001 (LP-184) in Atypical Teratoid Rhabdoid Tumor (ATRT) and other rare pediatric cancers. STAR-001 has received both Rare Pediatric Disease Designation and Orphan Drug Designation from the FDA for ATRT, along with additional designations for hepatoblastoma, rhabdomyosarcoma, and malignant rhabdoid tumors.
These designations provide potential pathways for FDA Priority Review Vouchers (PRVs) upon a potential approval. PRVs have historically been sold or transferred for significant value, with recent transactions in the range of
LP-284: Orphan Drug Designation and Clinical Advancement
In Q1 2026, LP-284 received FDA Orphan Drug Designation for soft tissue sarcomas, adding to existing designations for mantle cell lymphoma and high-grade B-cell lymphomas. In Q4 2025, Lantern presented clinical data at the 25th
RADR® AI Platform: Global Expansion and Commercial Momentum
In early 2026, Lantern announced the initiation of an
withZeta.ai: Multi-Agentic Co-Scientist Platform for Rare Cancers
A key commercial milestone in late 2025 was the introduction of withZeta.ai, a first-of-its-kind multi-agentic AI co-scientist platform. withZeta.ai is designed to accelerate drug development insights, therapeutic strategy generation, cancer trial development and research workflows across more than 438 rare cancers — a category of diseases that collectively represents a massive unmet medical need but where individual indications have historically been underserved due to small patient populations, sparse and scattered data and limited commercial incentives.
The platform leverages Lantern’s unique expertise and proprietary data assets in rare and orphan cancer drug development, combining multiple specialized AI agents that work collaboratively to analyze genomic data, identify potential therapeutic targets, predict drug-tumor interactions, and generate actionable development strategies. Since late
withZeta.ai represents a meaningful near-term commercialization opportunity for Lantern, as the platform is designed to generate recurring revenue through subscription and usage-based licensing models while reinforcing the company’s position as a leader in AI-driven oncology drug development. The company expects to provide further updates on commercial traction and partnership discussions related to withZeta.ai throughout 2026.
withZeta.ai: Market Opportunity, Scaling Strategy, and Vision
The withZeta.ai platform is architected to first address the unique challenges of rare cancer drug development, where fragmented data, small patient populations, and limited institutional knowledge have historically made therapeutic development economically and scientifically prohibitive. By aggregating and structuring insights across 438+ rare cancers into a unified AI co-scientist framework, withZeta.ai provides pharmaceutical and biotech researchers with capabilities that would otherwise require large, specialized teams and years of manual analysis.
Lantern’s longer term plan is to scale withZeta.ai beyond rare cancers into broader oncology indications and, subsequently, into rare diseases and other therapeutic areas through revenue generating collaborations with pharmaceutical companies. The platform’s multi-agentic architecture is designed to be extensible — the same collaborative AI agent framework that powers rare cancer insights can be configured and trained to address drug development challenges across neurology, immunology, metabolic diseases, and other complex therapeutic areas where data fragmentation and scientific complexity represent significant barriers to R&D productivity.
The global rare disease therapeutics market is projected to exceed
“2026 can be a critical year for the commercialization of our AI platforms to support broad-based drug development and scientific productivity in R&D,” said
Other AI Platform Highlights
- predictBBB.ai: 94.1% accuracy for blood-brain barrier permeability prediction; five of top eleven positions on the Therapeutic Data Commons Leaderboard. This tool has been significantly enhanced to encompass a wider range of molecular and structural analysis aimed at molecules and medicines.
- LBx-AI Liquid Biopsy: 86% accuracy for predicting treatment response in NSCLC; 0.76 Pearson correlation for PD-L1 level inference from ctDNA.
For the year ended
Addressing Fake News on Company CEO & Leadership
The company was made aware of an online third-party article unaffiliated with the company stating that the CEO of Lantern was stepping down and had resigned. This was a false and misleading article that seemed to be focused on shorting the Company’s stock price amongst traders.
Financial Results for Fourth Quarter and Full Year 2025
Balance Sheet:
Cash, cash equivalents, and marketable securities were approximately
Full Year 2025 Results:
Research and Development Expenses: R&D expenses were approximately
General and Administrative Expenses: G&A expenses were approximately
Net Loss: Net loss was approximately
Fourth Quarter 2025 Results:
Total Operating Expenses: Total operating expenses were approximately
Net Loss: Net loss was approximately
Capitalization:
As of
In
Consolidated Balance Sheets | ||
| ||
| ||
CURRENT ASSETS |
|
|
Cash and cash equivalents | ||
Marketable securities | 5,696,386 | 16,501,984 |
Prepaid expenses & other current assets | 683,948 | 1,234,566 |
Total current assets | 10,803,172 | 25,247,629 |
Property and equipment, net | 31,875 | 47,440 |
Operating lease right-of-use assets | 75,595 | 239,985 |
Deferred offering costs | 88,431 | — |
Other assets | 36,738 | 36,738 |
TOTAL ASSETS | ||
CURRENT LIABILITIES |
|
|
Accounts payable and accrued expenses | ||
Operating lease liabilities, current | 78,539 | 190,814 |
Total current liabilities | 4,501,587 | 4,331,175 |
Operating lease liabilities, non-current | — | 52,843 |
TOTAL LIABILITIES | 4,501,587 | 4,384,018 |
STOCKHOLDERS’ EQUITY |
|
|
Common Stock | 1,125 | 1,078 |
Additional paid-in capital | 99,652,724 | 97,058,323 |
Accumulated other comprehensive income | 25,430 | 153,990 |
Accumulated deficit | (93,145,055) | (76,025,617) |
Total stockholders’ equity | 6,534,224 | 21,187,774 |
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | ||
Consolidated Statements of Operations | ||
| ||
| Year Ended | Year Ended |
Operating expenses: |
|
|
General and administrative | ||
Research and development | 11,514,123 | 16,125,690 |
Total operating expenses | 17,978,494 | 22,216,437 |
Loss from operations | (17,978,494) | (22,216,437) |
Interest income | 437,931 | 742,355 |
Other income, net | 421,125 | 692,869 |
NET LOSS | ||
|
|
|
Net loss per share, basic and diluted | ||
Weighted-average shares outstanding | 10,898,175 | 10,762,319 |
2026 Corporate Objectives and Catalysts
Mid-May 2026 : Type C meeting with FDA to discuss proposed HARMONIC™ protocol amendments, including focusing enrollment on EGFR exon 21 L858R patients, extending LP-300 treatment cycles, and converting to a single-arm Simon two-stage design.- 2026: Planned Investigator Sponsored Trial evaluating LP-300 in combination with standard-of-care agents in frontline NSCLC patients with specific driver mutations.
- H1 2026: Planned initiation of LP-184 Phase 1b/2 trials in TNBC and NSCLC (subject to funding).
- H1 2026: Investigator-led clinical study initiation in
Denmark in PTGR1 overexpressing bladder cancers with DNA damage repair mutations. - 2026: Planned pediatric CNS cancer trial initiation through Starlight Therapeutics (subject to funding).
- 2026: Additional HARMONIC™ trial data readouts and potential partnership announcements.
- 2026: Scale-up of RADR® AI and withZeta.ai platform commercial efforts through
India AI Center of Excellence . - 2026: Continued commercialization of the withZeta.ai multi-agentic co-scientist platform, including conversion of beta engagements to commercial partnerships and expansion across the rare cancer research community through a subscription-based service.
- 2026: Pursuit of additional funding, including potential grant revenue, to fund planned operations and clinical advancement.
Conference Call Information
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.
About
Our lead development programs include a Phase 2 clinical program and multiple planned Phase 1b/2a clinical trials. We have also established a wholly-owned subsidiary, Starlight Therapeutics, to focus exclusively on the clinical execution of our promising therapies for CNS and brain cancers. Our AI-driven pipeline of innovative product candidates is estimated to have a combined annual market potential of over
Website: www.lanternpharma.com
Harmonic Trial: www.harmonictrial.com
LinkedIn: https://www.linkedin.com/company/lanternpharma/
X: @lanternpharma
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; the potential advantages of our RADR® platform and withZeta.ai platform in identifying drug candidates, accelerating drug development, and generating revenue through software licensing and subscription models; our strategic plans to advance the development of our drug candidates and antibody drug conjugate (ADC) development program; the planned commercialization of our AI platforms including withZeta.ai and the expected market opportunity for AI co-scientist platforms; estimates regarding the development timing for our drug candidates and ADC development program; expectations and estimates regarding clinical trial timing and patient enrollment; our research and development efforts of our internal drug discovery programs and the utilization of our RADR® platform to streamline the drug development process; our intention to leverage artificial intelligence, machine learning and genomic data to streamline and transform the pace, risk and cost of oncology drug discovery and development and to identify patient populations that would likely respond to a drug candidate; estimates regarding patient populations, potential markets and potential market sizes; sales estimates for our drug candidates and our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others.
Any statements that are not statements of historical fact (including, without limitation, statements that use words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “model,” “objective,” “aim,” “upcoming,” “should,” “will,” “would,” or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the risk that we may not be able to secure sufficient future funding when needed and as required to advance and support our existing and planned clinical trials and operations, (ii) the risk that observations in preclinical studies and early or preliminary observations in clinical studies do not ensure that later observations, studies and development will be consistent or successful, (iii) the risk that our research and the research of our collaborators may not be successful, (iv) the risk that we may not be successful in licensing potential candidates or in completing potential partnerships and collaborations, (v) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates, (vi) the risk that no drug product based on our proprietary RADR® AI platform has received FDA marketing approval or otherwise been incorporated into a commercial product, (vii) the risk that our AI platform commercialization efforts, including withZeta.ai, may not generate the anticipated revenue or achieve the expected market adoption, and (viii) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended
You may access our Annual Report on Form 10-K for the year ended
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Investor Relations
ir@lanternpharma.com
+1-972-277-1136
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