Full Press Release Details
Pharma Reports First Quarter 2026 Financial Results and Provides Business Updates
Execution Drives 47% Reduction in R&D Spend While Advancing Multiple Clinical Programs, Launching Multi-Agentic AI Platform withZeta.ai
Commercially, and Strengthening Balance Sheet with Financing of up to $9.25 Million
| Q1 net loss reduced 27% year-over-year while progressing multiple precision oncology programs | ||
| Commercial introduction of withZeta.ai, the first multi-agentic AI co-scientist platform purpose-built for rare and complex cancer drug development | ||
| Successful outcome from Type C meeting request with the FDA focused on the LP-300 HARMONIC Clinical Trial | ||
| Pediatric brain cancer IND cleared by FDA for enrollment for Lantern Pharma subsidiary, Starlight Therapeutics | ||
| Strategic plan to create an independent entity composed of withZeta.ai assets | ||
| Financial Position: Cash, cash equivalents, and marketable securities were approximately $6.3 million as of March 31, 2026; together with an additional approximately $4.4 million in gross proceeds from the May 14, 2026 financing, the Company's pro forma liquidity is expected to fund operations into the middle of the first quarter of 2027. |
WIRE)- Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage AI-driven precision oncology 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 first quarter ended March 31, 2026,
and provided an update on its portfolio of AI-driven drug candidates and AI platforms.
first quarter of 2026 was defined by capital-efficient execution across Lantern's clinical and AI platform pipelines. The Company
advanced multiple clinical-stage programs through meaningful regulatory and scientific milestones, including a successful outcome from
an FDA Type C meeting interaction on the Phase 2 HARMONIC trial of LP-300 and IND clearance for the first pediatric CNS cancer
program of wholly-owned subsidiary Starlight Therapeutics, while reducing research and development spend by 47% year-over-year. In parallel,
Lantern moved its proprietary AI infrastructure from internal capability to external commercial product with the launch of withZeta.ai,
the first multi-agentic AI co-scientist platform purpose-built for rare and complex cancer drug development. The recent fundraise of
up to $9.25 million (which includes the potential future exercise of warrants) further strengthens the Company's balance sheet
and supports continued advancement of both its clinical pipeline and its AI commercialization strategy.
first quarter of 2026 demonstrated the operating discipline and capital-efficient execution that we believe is differentiating Lantern
from other clinical-stage and AI-driven oncology companies," said Panna Sharma, President and CEO of Lantern Pharma. "We
reduced our R&D spend by 47% year-over-year while simultaneously advancing multiple clinical programs through important regulatory
milestones, achieving a successful outcome from our Type C meeting request with the FDA on the HARMONIC trial, and clearing the
path for Starlight Therapeutics' first pediatric brain cancer trial. This level of milestone delivery on a tightly disciplined
budget reflects exactly what our AI-driven drug development model was designed to do - develop more programs, more quickly, and
at a fraction of the historical cost of biopharma R&D."
addition to Lantern's clinical pipeline advancements, the first quarter also marked a pivotal evolution in the commercialization
of the Company's AI assets. With the public launch of withZeta.ai and the continued global expansion of the RADR
platform through the Company's initiation of an AI Center of Excellence in India, Lantern is now operating two distinct value-creation
engines: a clinical-stage drug development business aimed at advancing therapies across solid tumors, blood cancers, and pediatric brain
cancers; and an AI platform business addressing the multi-billion-dollar opportunity in AI-enabled drug discovery and rare cancer research.
To accelerate value realization across both engines, the Company has announced a strategic plan to create an independent business entity
composed of its withZeta.ai platform assets, intended to access dedicated funding sources and pursue valuation distinct from clinical
drug development operations.
represents Lantern's first agentic-based commercial AI product, and we believe it is positioned to capture a meaningful share of
what we view as a $20 to $50 billion near-term market opportunity in AI-driven drug development," continued Mr. Sharma.
"Separating our withZeta.ai assets into an independent entity is intended to unlock dedicated funding, attract specialized talent,
and allow investors to value each business - clinical drug development and AI platforms - on its own terms. Combined with
the recent financing, which extends our operating runway into the first quarter of 2027, Lantern enters the remainder of 2026 with a
stronger balance sheet, a sharper commercial focus, and a portfolio of AI-driven oncology drug candidates with an estimated combined
annual market potential exceeding $15 billion."
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) in NSCLC focused
on never-smokers and non-smokers with the EGFR exon 21 L858R mutation; planned Phase 1b/2 trials (LP-184) in precision, biomarker-defined
solid tumors; and an ongoing Phase 1 program in hematologic malignancies and adult soft tissue sarcomas (LP-284). Additionally, through
wholly-owned subsidiary Starlight Therapeutics, the Company has a planned Phase 1 pediatric CNS cancer trial and a planned Phase 1b trial
in adult relapsed glioblastoma (GBM) in combination with spironolactone, both with STAR-001 (LP-184). Each program has been guided by
the RADR platform's AI-driven insights. On average, Lantern's 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: Successful Type C Meeting Request Outcome and Path Forward
May 2026, Lantern received responses from its Type C meeting request to the U.S. Food and Drug Administration to discuss proposed protocol
amendments to the Phase 2 HARMONIC trial of LP-300 in never-smokers with advanced non-small cell lung cancer (NSCLC) adenocarcinoma.
The Company received a successful outcome from the meeting request and no objections from the FDA on key proposed amendments to the study,
providing an emergent regulatory path forward for the trial.
| Focused Patient Enrollment: Future HARMONIC enrollment will focus on patients with the EGFR exon 21 L858R mutation, a subtype of tyrosine kinase mutations that demonstrates lower sensitivity and inferior treatment outcome to osimertinib based therapy. Preliminary analysis of study data suggests that patients with this mutation may derive greater clinical benefit from the LP-300 triplet regimen. | ||
| Extended Treatment Cycles: The maximum number of LP-300 treatment cycles will be increased from six to eight, supported by 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. | ||
| Study Design Change: The study will discontinue enrollment into the control arm while migrating into a single arm study and only enroll additional patients with EGFR exon 21 L858R mutation. This change reflects the evolution of the treatment landscape for TKI-refractory NSCLC that has made continued randomization to the control arm increasingly challenging. |
HARMONIC trial is ongoing at clinical sites in the United States, Japan, and Taiwan. Targeted enrollment in Japan was completed
in July 2025 across five clinical sites, including the National Cancer Center Tokyo, and the trial continues to enroll patients in the
U.S., as well as in Taiwan, where more than 50% of lung cancer cases occur in never-smokers. 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.
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 second 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
Therapeutics: FDA IND Clearance for Pediatric CNS Cancer Trial and Expanded Adult GBM Program
early 2026, the FDA cleared the Investigational New Drug (IND) application 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, marking a pivotal
regulatory milestone for Lantern's wholly-owned subsidiary. 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
designations provide potential pathways for FDA Priority Review Vouchers (PRVs) upon a potential future 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 Designations for ATRT, hepatoblastoma, rhabdomyosarcoma, and malignant rhabdoid tumors
each independently qualifies for a potential PRV upon potential FDA approval and meeting other program conditions.
addition to the pediatric CNS program, Starlight is advancing plans for a Phase 1b trial of STAR-001 in adult patients with relapsed
glioblastoma (GBM) in combination with spironolactone. Preclinical studies have demonstrated meaningful synergy between STAR-001 and
spironolactone in GBM models, with combination treatment producing enhanced anti-tumor activity relative to either agent alone. The combination
leverages Lantern's RADR -driven insights into DNA damage repair vulnerabilities in GBM, and Starlight believes
the program has the potential to address a significant unmet need in a cancer indication where median overall survival following recurrence
remains under nine months despite decades of clinical research.
remains one of the most treatment-resistant cancers, with approximately 12,000 new cases diagnosed annually in the United States and
a global incidence representing a multi-billion-dollar market opportunity. Lantern and Starlight are exploring partnership and collaboration
opportunities to accelerate the development of STAR-001 across both pediatric and adult CNS indications.
Commercial Launch & Evolution Towards An Independent Entity
April 2026, Lantern publicly launched withZeta.ai, the first multi-agentic AI co-scientist platform purpose-built for rare and complex
cancer drug development. The launch was marked by a Nasdaq MarketSite debut, a live demonstration at the American Association for Cancer
Research (AACR) 2026 Annual Meeting, and a dedicated investor and analyst webinar covering five oncology use cases ranging from biomarker
discovery to clinical trial design optimization. Since its introduction, withZeta.ai has been actively used and evaluated by biotech
companies, cancer research centers, biopharma consultants, and institutional investors across the United States, Europe, and Asia.
is designed to accelerate drug development insights, therapeutic strategy generation, cancer trial development, and research workflows
across more than 438 rare cancer indications - 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 combines multiple specialized AI agents that work collaboratively to analyze genomic data,
identify potential therapeutic targets, predict drug-tumor interactions, and generate actionable development strategies, drawing on Lantern's
unique expertise and proprietary data assets in rare and orphan cancer drug development.
Separation into an Independent Business Entity
connection with the May 2026 financing, Lantern announced a strategic plan to separate withZeta.ai and related personnel
into an independent business entity under the leadership of Panna Sharma. The separation is intended to provide withZeta.ai with dedicated
funding sources and the opportunity to realize valuation multiples distinct from Lantern's clinical-stage drug development operations.
reflects Lantern's broader strategic evolution toward operating two distinct value-creation engines: 1) a clinical-stage
drug development business aimed at advancing therapies across solid tumors, blood cancers, and CNS cancers; and 2) an AI