Lantern Pharma (NASDAQ:LTRN) executives highlighted clinical progress across multiple oncology programs, cost reductions, and plans to commercialize its artificial intelligence platform during the company’s fourth-quarter and full-year 2025 results call. President and CEO Panna Sharma also used the call to deny what he described as “malicious and fake news” circulating online claiming he was departing the company.
Management outlines “defining year” and addresses online rumors
Sharma said 2025 was “a defining year” in which the company believes it achieved clinical validation across multiple programs while laying groundwork for its next phase of growth. He pointed to several milestones: observations from the Phase II Harmonic trial for LP-300, completion of a Phase IA portion for the LP-184 clinical trial, and an FDA IND clearance for a pediatric central nervous system (CNS) cancer program through Starlight Therapeutics.
During prepared remarks, Sharma directly addressed reports claiming he was stepping down. “This is categorically untrue,” he said, adding that Lantern intends to pursue “appropriate civil, criminal, and legal recourse against those responsible.”
LP-300 Harmonic trial: enrollment, prior response rates, and FDA Type C meeting
Sharma said LP-300’s Phase II Harmonic trial is focused on never-smokers with non-small cell lung cancer (NSCLC) who progressed after treatment with tyrosine kinase inhibitors. He characterized the patient population as a growing segment in Asia and said there are currently no therapies approved specifically for this group.
According to Sharma, the Harmonic trial continued through the fourth quarter and into early 2026 with enrollment and follow-up across sites in the U.S., Japan, and Taiwan. He said Lantern completed targeted enrollment in Japan ahead of schedule across five clinical sites, including the National Cancer Center Hospital in Tokyo, and noted that investigators presented data from Asian and U.S. cohorts at the 66th annual meeting of the Japan Lung Cancer Society.
Sharma cited previously disclosed results from the trial’s initial safety lead-in cohort, including an 86% clinical benefit rate and a 43% objective response rate, as well as “1 patient with a durable complete response and survival continuing for nearly 2 years.”
He also said Lantern submitted a Type C meeting package to the FDA in March, with the meeting scheduled for mid-May 2026. Lantern is seeking feedback on three proposed protocol amendments:
- Focusing future enrollment on patients with the EGFR exon 21 L858R mutation, where the company’s preliminary analysis suggests greater benefit from the LP-300 regimen in combination with a chemotherapy doublet.
- Increasing the maximum LP-300 treatment cycles from six to eight based on safety data and the mechanism.
- Converting the study to a Phase II single-arm Simon’s two-stage design, which Sharma said reflects an evolving treatment landscape that has made continued randomization to the control arm “increasingly challenging.”
Sharma said the company is exploring global collaboration and partnering opportunities for LP-300 and expects additional clinical updates “in the coming weeks,” including further insights on the L858R population. He also said an investigator-sponsored trial combining LP-300 with osimertinib and chemotherapy in the front-line setting with specific driver mutations is advancing.
LP-184 Phase I results and planned precision oncology studies
Sharma said Lantern reported additional positive Phase I results for LP-184 in the fourth quarter, describing durable disease control in heavily pretreated advanced cancer patients. He said the trial enrolled 63 patients and achieved its primary endpoints, with a 48% clinical benefit rate at or above the therapeutic dose threshold.
He added that tumor reductions were observed in patients with DNA damage repair mutations, including CHEK2, ATM, BRCA1, and STK11, which he said were flagged through RADR-driven insights. Lantern established a recommended Phase II dose of 0.39 mg/kg and reported a favorable safety profile, with clinical benefits described in cancers including relapsed glioblastoma (GBM), gastrointestinal stromal tumors, and thymic carcinoma. Sharma said some patients have seen clinical benefit for more than a year.
Sharma outlined a Phase IB/Phase IIA development plan and described three targeted trials the company is positioning for, subject to additional funding:
- Triple-negative breast cancer in a combination study with olaparib; Sharma said the protocol has been FDA-reviewed and that LP-184 holds Fast Track designation.
- NSCLC with KEAP1 or STK11 mutations.
- An investigator-led bladder cancer study planned in Denmark targeting PTGR1-overexpressing tumors with DNA damage repair mutations.
In later comments, Sharma said the Denmark bladder cancer study is expected to start and is funded by the Danish government and the Danish Cancer Society. He also said the company has planned initiation—subject to funding—of LP-184 studies in triple-negative breast cancer and CNS cancers.
Sharma also discussed research from a collaboration with MD Anderson, stating LP-184 showed an ability to transform “immunologically cold tumors” into “hot tumors,” particularly in triple-negative breast cancer, which he said could have implications for immunotherapy combinations.
Starlight Therapeutics pediatric CNS IND and designations
Sharma said Starlight Therapeutics, Lantern’s wholly owned CNS oncology subsidiary, recently received FDA IND clearance for a planned Phase I pediatric CNS cancer trial featuring a combination that includes spironolactone. He said the design aims to exploit synthetic lethality in brain tumors by using spironolactone to degrade ERCC3, a DNA repair protein, to increase vulnerability that STAR-001 can then target.
Sharma said the FDA cleared the IND in early 2026 for recurrent CNS tumors, atypical teratoid/rhabdoid tumor (ATRT), and other rare pediatric tumors. He added that STAR-001 has received Rare Pediatric Disease Designation and Orphan Drug Designation for ATRT, as well as additional Rare Pediatric Disease Designations for hepatoblastoma, rhabdomyosarcoma, and malignant rhabdoid tumors.
Sharma discussed the potential value of Priority Review Vouchers tied to rare pediatric disease approvals, citing “recent transactions in the range of $150 million-$200 million,” while emphasizing that eligibility would depend on potential approval and other program conditions. He also cited preclinical work showing a 3- to 6-fold increase in GBM cell sensitivity with the combination and said STAR-001 has shown antitumor activity in GBM regardless of MGMT status.
RADR and withZeta: commercialization plans and 2026 catalysts
Sharma positioned Lantern’s AI platform as an increasingly important value driver beyond drug development. He described RADR as integrating “200-300 billion-plus oncology-focused data points” and said Lantern established an AI Center of Excellence in India in early 2026 to expand capabilities and scalability, including around-the-clock development.
He also discussed Lantern’s “withZeta” product as a multi-agent “agentic AI” system designed to support drug discovery workflows, from literature synthesis and pathway analysis to biomarker identification and trial design. Sharma said the system has been launched to multiple demo partners and, since late 2025, has been in beta testing with “over 25 biotech companies, cancer research centers, biopharma consultants, and even some CROs and investment banks.”
Sharma said Lantern plans a “major launch” of withZeta at AACR next month and expects to convert beta engagements into commercial partnerships while launching a multi-tiered subscription offering.
Financial results: lower R&D spend, reduced losses, and cash runway into mid-2026
CFO David Margrave reported fourth-quarter 2025 general and administrative expenses of approximately $1.5 million, compared with approximately $1.6 million in the prior-year quarter. R&D expenses were approximately $2.7 million, down from approximately $4.3 million in the fourth quarter of 2024.
Margrave said Lantern recorded a net loss of approximately $4.1 million, or $0.36 per share, in the fourth quarter of 2025, compared with a net loss of approximately $5.9 million, or $0.54 per share, in the prior-year quarter.
For the full year 2025, Margrave reported:
- R&D expenses of approximately $11.5 million, down from approximately $16.1 million in 2024, primarily due to an approximate $4.0 million reduction in research studies and materials related to clinical trials, along with decreases in payroll and consulting expenses.
- G&A expenses of approximately $6.5 million, up from approximately $6.1 million in 2024, driven by higher business development and investor relations spending, patent costs, and corporate insurance.
- Net loss of approximately $17.1 million, or $1.57 per share, compared with approximately $20.8 million, or $1.93 per share, in 2024.
Margrave said interest income and other income net totaled approximately $0.9 million and partially offset the 2025 loss from operations.
Lantern ended 2025 with approximately $10.1 million in cash, cash equivalents, and marketable securities. Margrave said the company believes its existing cash will fund operating expenses and capital expenditure requirements until “at least approximately late July 2026 to mid-September 2026,” while noting Lantern “will need to raise substantial additional funding in the near future” and is evaluating funding alternatives.
As of Dec. 31, 2025, Margrave said Lantern had 11,254,697 shares outstanding, no outstanding warrants, and options to purchase 1,296,126 shares, for total fully diluted shares of approximately 12.6 million.
About Lantern Pharma (NASDAQ:LTRN)
Lantern Pharma, Inc is a clinical-stage oncology company leveraging artificial intelligence (AI) and machine learning to accelerate the discovery and development of targeted cancer therapies. Headquartered in Dallas, Texas, Lantern Pharma’s proprietary RADR® platform integrates large-scale genomic, transcriptomic and chemical data to identify novel drug candidates and predict patient populations most likely to benefit from treatment.
The company’s pipeline focuses on molecules designed to address cancers with high unmet medical need.
