Full Press Release Details
Pharma Reports Fourth Quarter and Full Year 2025
Results and Provides Business Updates
of Clinical Validation and Strategic Expansion Across Pipeline, AI Platform Advances Towards Commercialization, and Global Trial Milestones
WIRE)- March 30, 2026 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 fourth quarter and full year 2025 ended
December 31, 2025, and provided an update on its portfolio of AI-driven drug candidates and AI platforms, RADR and withZeta.ai.
was a defining year for Lantern Pharma as we achieved clinical validation across multiple programs while establishing the foundation
for our next phase of growth," said Panna Sharma, CEO & President of Lantern Pharma. "The encouraging and developing
LP-300 Phase 2 HARMONIC observations, combined with successful Phase 1a completion for LP-184 and FDA IND clearance for our pediatric
CNS cancer program through Starlight Therapeutics, represent transformational milestones that validate and strengthen our AI-driven approach
to precision oncology. Our full-year results reflect disciplined execution with a 19% reduction in total operating expenses year-over-year,
even as we advanced multiple clinical programs through key inflection points and introduced a highly unique multi-agentic system aimed
at conquering rare cancers. As we move into 2026, we are positioning to advance multiple high-value clinical programs, expand our RADR
platform's commercial reach and revenue potential globally through our new AI Center of Excellence in India and strengthen our
Pipeline Developments
AI-driven clinical pipeline encompasses multiple drug candidates across solid tumors, blood cancers, and pediatric oncology, with a combined
estimated annual market potential exceeding $15 billion. The portfolio includes a Phase 2 clinical program (LP-300), multiple programs
advancing toward Phase 1b/2 trials (LP-184), an ongoing Phase 1 trial in hematologic malignancies (LP-284), and a planned Phase 1 pediatric
CNS cancer trial (STAR-001) through Starlight Therapeutics. Each program has been guided by the RADR platform's AI-driven
insights. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials
in 2-3 years and at approximately $1.0-2.5 million per program.
HARMONIC Trial: Continued Progress and Strategic Momentum
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 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
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.
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.
NSCLC is increasingly recognized as a distinct disease entity with unique clinical and genomic characteristics, representing a global
market opportunity estimated at over $4 billion annually. Currently, there are no therapies specifically approved for never-smoker NSCLC
Phase 1a Completion and Advancement Toward Phase 1b/2 Trials
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.
Phase 1a Highlights:
1b/2 Development Plans (subject to additional funding):
Therapeutics: FDA IND Clearance for Pediatric CNS Cancer Trial
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
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 $100 million to $150 million or more, representing
a potentially meaningful source of non-dilutive value for Lantern and its shareholders independent of the commercial potential of the
underlying therapy. The Rare Pediatric Disease Designation for ATRT, hepatoblastoma, rhabdomyosarcoma, and malignant rhabdoid tumors
each independently qualifies for a potential PRV upon potential FDA approval and meeting other program conditions.
Orphan Drug Designation and Clinical Advancement
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 LL&M Congress showcasing a confirmed complete
metabolic response in a heavily pretreated DLBCL patient. LP-284 benefits from composition of matter patents providing protection through
2039 in the majority of the major medicine markets (USA, EU, Japan, China, India, Mexico, Korea, and Australia).
AI Platform: Global Expansion and Commercial Momentum
Center of Excellence in India
early 2026, Lantern announced the initiation of an AI Center of Excellence in India to industrialize and grow the RADR platform,
the withZeta.ai system and accelerate global development opportunities with biopharma companies looking to leverage AI as a service.
Multi-Agentic Co-Scientist Platform for Rare Cancers
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.
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 December 2025, withZeta.ai has been in active demo and beta
testing with over 25 biotech companies, cancer research centers, and biopharma consultants, generating significant interest and early
engagement from the industry.
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
Market Opportunity, Scaling Strategy, and Vision
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.
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.
global rare disease therapeutics market is projected to exceed $300 billion by 2028, and the broader pharmaceutical R&D outsourcing
and AI-enabled drug discovery market represents an additional multi-billion-dollar opportunity. Lantern believes that withZeta.ai is
positioned at the intersection of these high-growth markets, with a differentiated offering that combines proprietary oncology data,
validated AI algorithms, and a practical co-scientist user experience designed for bench scientists and clinical development teams.
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 Mr. Sharma. "We are building for a future where AI co-scientists are commonplace in knowledge work
across the pharmaceutical and biotech industries - augmenting human expertise, accelerating discovery timelines, and dramatically
improving the economics of drug development. We believe this represents a potential near-term market opportunity of $20 to $50 billion,
and withZeta.ai is our first agentic-based commercial product designed to capture a meaningful share of that market. The early engagement
from a broad range of organizations in our beta program validates both the demand and the differentiation of our approach."
AI Platform Highlights
Investment by Program (Full Year 2025):