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2週前
Lantern Pharma Reports HARMONIC™ Data Showing LP-300 Progression-Free Survival Benefit Deepens with Treatment Duration in EGFR Exon 21 L858R Lung CancerJune 2, 2026 8:13 AM
Business Wire Exon 21 L858R NSCLC Mutated Patients Treated Through Up to Six Cycles Reached 8.9-Month Median PFS; Durable Responses Beyond Two Years; and a Consistently Clean Safety Profile. PFS benefit deepens with treatment duration: L858R patients treated through up to six cycles of LP-300 reached an 8.9-month median PFS, versus 8.4 months overall (n=15) – future patients will be eligible to receive up to 8 doses of LP-300. Durable, deep responses: tumor reduction in over 70% of evaluable L858R patients, responses beyond two years, and a 77% clinical benefit rate. Clean, treatment-enabling safety: no clinically meaningful toxicity beyond chemotherapy, comparing favorably with amivantamab plus chemotherapy on a cross-trial basis. Partnering and KOL discussions ongoing during ASCO 2026: updated data and slides filed today on Form 8-K and are in use for partnering and clinical discussions during ASCO 2026 in Chicago. Lantern Pharma Inc. (NASDAQ: LTRN), an AI-driven precision oncology company, today reported clinical data and updates in the form of a presentation from its ongoing Phase 2 HARMONIC™ trial (NCT05456256) evaluating LP-300 in combination with carboplatin and pemetrexed in patients with EGFR Exon 21 L858R-mutant non-small cell lung cancer (NSCLC) who have progressed following TKI-based therapy. The emerging dataset (data cutoff May 11, 2026) reveals a coherent pattern: the progression-free survival benefit of LP-300 deepens with treatment duration, and the signal is most pronounced in the L858R subgroup — a molecularly defined population with a poor prognosis and limited options following frontline TKI therapy. The Company has furnished the presentation and slides as an exhibit to a Current Report on Form 8-K filed today, and is using the updated data and slides for partnering and clinical discussions during ASCO 2026 in Chicago. “What we are seeing is an early signal that strengthens the longer the biomarker specific patients remain on therapy, and very importantly no notable changes in the exceptionally clean safety and tolerability profile for LP-300,” said Panna Sharma, CEO & President of Lantern Pharma. “These patient observations and clinical benefit patterns provide the rationale behind the recently FDA-cleared protocol amendment extending LP-300 dosing from a maximum of six to eight cycles, and reinforces the Company’s focus on the highly undermet need for the L858R patient subgroup – which is about 40% of EGFR mutated patients globally.” A Deepening Signal: Benefit Concentrates with Treatment Duration A key finding and early observation emerging from HARMONIC™ is the relationship between treatment duration and depth of benefit. Patients who received up to six cycles of LP-300 derived greater progression-free survival benefit than those treated for fewer cycles, and within the L858R subgroup this duration effect was most evident — a median PFS of 8.9 months in patients treated through up to six cycles, against 8.4 months in the overall L858R cohort (n=15). The L858R subgroup also corresponded to a hazard ratio of 0.37 (95% CI 0.15–0.89) favoring L858R. The directional trend toward longer PFS with additional cycles provides the basis for extending treatment duration to eight cycles. Depth and Durability of Response Beyond the duration relationship, the data point to durable disease control in the L858R population. More than 70% of evaluable L858R patients experienced a reduction in target-lesion size — including a complete response and multiple partial responses among the deepest responders — and durable responses were sustained beyond two years in select patients. The L858R cohort showed a 77% clinical benefit rate, consistent with the depth and durability observed across the response data. 8.9 mo Median PFS — L858R, up to 6 cycles >70% Evaluable L858R patients with tumor reduction 2+ yrs Durable responses in select L858R patients 77% Clinical benefit rate — L858R cohort In a multivariable Cox proportional-hazards analysis, L858R remained significantly and independently associated with PFS benefit after adjustment for race and gender (hazard ratio 0.36; 95% CI 0.15–0.90; p=0.028), with the association persisting when adjusting for TP53 mutation status. These analyses are exploratory and based on a small cohort; they are intended to characterize the emerging signal and inform the enriched study design – which Lantern is pursuing going forward – rather than to establish efficacy. A Consistently Clean Safety Profile Supports Extended Treatment Critically, the deepening efficacy signal is accompanied by a tolerability profile that supports longer treatment durations. Across patients treated with LP-300 plus chemotherapy (N=31), LP-300 added no clinically meaningful toxicity beyond the carboplatin/pemetrexed backbone. On a cross-trial basis — provided for context only and not a head-to-head comparison — LP-300 plus chemotherapy compared favorably with the FDA-approved amivantamab-plus-chemotherapy regimen reported in the Phase 3 MARIPOSA-2 study (Passaro A, et al. Ann Oncol 2024), particularly on the administration-burden and dermatologic toxicities that most limit sustained treatment in heavily pre-treated patients: Adverse Event (any grade unless noted) LP-300 + Chemo (N=31) Amivantamab + Chemo (N=130)¹ Treatment-related serious adverse event 3% 23% TEAE leading to dose delay (any study drug) 19% 65% TEAE leading to drug discontinuation 6% 18% Infusion-related reaction (TRAE) 7% 58% Rash (TRAE) 7% 43% Paronychia (TRAE) 0% 36% Stomatitis (TRAE) 0% 31% ¹ Cross-trial comparison; not a head-to-head study. Amivantamab + chemotherapy data from Passaro A, et al. Annals of Oncology 2024;35(1):77–90 (MARIPOSA-2). LP-300 + chemotherapy data are preliminary; HARMONIC™ data cutoff May 11, 2026. Competitive Context: Comparable Efficacy, Differentiated Tolerability Amivantamab plus chemotherapy is FDA-approved in the post-osimertinib setting and represents the current benchmark in this space, with a reported 9.7-month median PFS in L858R patients. LP-300’s emerging profile is positioned not as a claim of superior anti-tumor efficacy, but as a comparable efficacy range with a substantially more favorable safety, tolerability, and administration profile — highly relevant in a heavily pre-treated population where tolerability drives real-world outcomes such as quality of life, reduced costs and reduced clinical burden. Regimen ORR mPFS Key Tolerability Profile LP-300 + Carboplatin + Pemetrexed (HARMONIC™ — L858R enriched) 43%* 8.4 mo* (6.2–NE) 8.9 mo** Grade 1–2 predominant; no new added toxicity vs. chemo; 3% serious TRAEs Amivantamab + Chemo (MARIPOSA-2) [FDA-approved, post-osimertinib] (L858R patients) 36% 9.7 mo (5.9–11.3) 23% serious TRAEs; 58% infusion reactions; 36% paronychia Carboplatin + Pemetrexed alone (historical standard of care) 27–36% 4.2–5.5 mo Standard chemotherapy toxicities *Preliminary data. ORR derived from the initial safety lead-in (n=7); HARMONIC™ mPFS from the L858R-enriched cohort (n=31, data cutoff May 11, 2026). **Patients who received up to six cycles. All comparisons are cross-trial and not head-to-head. NE = not estimable. Featured for Partnering and Clinical Discussions During ASCO 2026 The convergence of a duration-dependent efficacy signal with a clean, sustainable safety profile carries a clear strategic implication: patients can be treated longer, and longer treatment appears to deepen benefit. This relationship underpins the recently FDA-cleared amendment extending LP-300 dosing to eight cycles and the Company’s decision to concentrate enrollment on the L858R subgroup. Lantern Pharma has furnished the accompanying slides on Form 8-K and is using the updated dataset for partnering and clinical discussions during ASCO 2026 in Chicago, including potential global and regional licensing and co-development opportunities in never-smoker NSCLC. The Company expects to report additional data as the enriched L858R cohort matures. LP-300 Shaped & Supported By Lantern’s AI Platform For Drug Development Indication development and refinement for LP-300 were in part supported by early observations from prior trials and large scale differential gene expression and mutational analysis across NSCLC data sets. Panna Sharma commented, "Our LP-300 program reflects a data-driven, AI-powered approach to understanding how a previously overlooked molecule could meaningfully serve the needs of L858R NSCLC patients — a population that has consistently underperformed on existing therapies. The convergence of molecular modeling, high-resolution biology, and biomarker-driven patient selection is fundamentally changing what is possible for precision oncology drug developers, and we believe LP-300 is well positioned at that intersection." About the HARMONIC™ Trial HARMONIC™ (NCT05456256) is a Phase 2 clinical trial investigating LP-300 in combination with pemetrexed and carboplatin in never/non-smoker patients with advanced lung adenocarcinoma that has progressed following prior TKI therapy. The trial has enrolled in the United States, Taiwan, and Japan. Primary endpoints are progression-free survival and overall survival; secondary endpoints include objective response rate, duration of response, and clinical benefit rate. About LP-300 LP-300 is a small-molecule investigational agent with a multimodal mechanism of action, including receptor tyrosine kinase modulation and redox regulation. It has been administered to more than 1,000 individuals across prior clinical studies. LP-300 is being developed using insights from Lantern’s proprietary RADR® AI platform. LP-300 has not received marketing approval from the FDA or any other regulatory authority for any indication. About Lantern Pharma Lantern Pharma (NASDAQ: LTRN) is an AI-driven precision oncology company transforming the cost, pace, and timeline of oncology drug discovery and development. Its proprietary RADR® platform leverages machine learning and large-scale genomic and clinical data to identify biomarker signatures and guide the development of targeted therapies for patients with significant unmet need. 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; plans, objectives and expectations regarding the HARMONIC™ clinical trial; LP-300’s potential clinical activity and tolerability profile; our clinical development plans; expectations and estimates regarding clinical trial timing and patient enrollment; estimates regarding patient populations, potential markets and potential market sizes; 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 emerging or preliminary observations in clinical studies do not ensure that later observations, studies and development will be consistent or successful, (iii) the risk that any clinical benefit observed to date relating to LP-300 may not be reproduced in the completed HARMONIC™ trial or in larger or confirmatory studies, (iv) the risk that clinical data referenced in this press release relating to the HARMONIC™ clinical trial are exploratory and preliminary, based on small patient cohorts, and may not be representative of outcomes in broader populations, (v) the risk that cross-trial comparisons are provided for context only and should not be interpreted as direct evidence of comparative safety or efficacy, (vi) the risk that our research and the research of our collaborators may not be successful, (vii) the risk that we may not be successful in licensing our product candidates or in completing potential partnerships and collaborations, (viii) 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, (ix) the risk that no drug product based on our proprietary AI platforms has received FDA marketing approval or otherwise been incorporated into a commercial product, and (x) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 30, 2026. You may access our Annual Report on Form 10-K for the year ended December 31, 2025 under the investor SEC filings tab of our website at www.lanternpharma.com or on the SEC's website at www.sec.gov. Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations. View source version on businesswire.com: https://www.businesswire.com/news/home/20260602549826/en/ Investor & Media Contact
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Email: IR @daddydo Original: Lantern Pharma Reports HARMONIC™ Data Showing LP-300 Progression-Free Survival Benefit Deepens with Treatment Duration in EGFR Exon 21 L858R Lung Cancer
US Market News
4週前
Lantern Pharma Announces Successful Outcome of FDA Type C Meeting Request for HARMONIC™ Phase 2 Trial of LP-300 in Never-Smokers with NSCLCMay 19, 2026 7:30 AM
Business Wire The FDA raised no objections to Lantern's key proposed protocol amendments to the HARMONIC™ clinical trial. Amendments include: (1) enriching enrollment for patients with EGFR exon 21 L858R mutations; (2) extending LP-300 dosing to a maximum of eight cycles; and (3) transitioning to a single-arm study design — changes that align with emerging data and support a clearer regulatory and partnering path. EGFR exon 21 L858R mutations account for approximately 40% of all EGFR-mutant NSCLC globally and up to 50% in Asian populations — a molecularly defined subset that consistently experiences inferior outcomes when treated with current EGFR-targeted therapies relative to patients with exon 19 deletions. Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage, AI-driven precision oncology company, today announced that it has received a successful response to its recent Type C meeting request from the U.S. Food and Drug Administration (FDA), focused on the ongoing Phase 2 HARMONIC™ trial of LP-300 in never-smokers with advanced non-small cell lung cancer (NSCLC) adenocarcinoma. In its written responses to Lantern's Type C meeting request, the FDA raised no objections to key proposed protocol amendments, providing a more focused, clearer regulatory path forward for the HARMONIC™ trial and for the future development of LP-300 in this distinct, high-need patient population. The HARMONIC™ trial is designed to evaluate LP-300, a small molecule given in combination with carboplatin and pemetrexed, in never-smokers with advanced NSCLC adenocarcinoma who have experienced disease progression following treatment with kinase inhibitors. Never-smoker NSCLC is increasingly recognized as a distinct disease entity with unique clinical and genomic features. Globally, approximately 400,000 to 500,000 patients are diagnosed with never-smoker NSCLC each year — a patient population that, if classified separately, would rank among the most common cancers worldwide. Despite this scale, no therapies have been specifically developed or labeled for the never-smoker NSCLC patient population, and the EGFR exon 21 L858R subset in particular continues to experience inferior outcomes when treated with currently available standards of care. “In our view, this successful Type C interaction with the FDA is a meaningful de-risking milestone for the LP-300 program and for the HARMONIC™ trial. The FDA's response to our proposed amendments supports our strategy to focus HARMONIC™ on the EGFR exon 21 L858R-mutant never-smoker population, where emerging data suggest LP-300 may offer meaningful differentiated benefit when added to standard chemotherapy following TKI failure.” — Panna Sharma, President and Chief Executive Officer, Lantern Pharma Inc. Focused Enrollment in EGFR Exon 21 L858R Never-Smokers Under the amended protocol supported by the FDA's Type C responses, Lantern plans to focus all future HARMONIC™ enrollment on patients harboring the EGFR exon 21 L858R mutation, a subtype of EGFR kinase domain mutations associated with lower TKI binding affinity and inferior outcomes on osimertinib-based therapy relative to patients with exon 19 deletions. Preliminary analyses from the ongoing HARMONIC™ trial suggest that patients with EGFR exon 21 L858R-mutant disease may derive greater clinical benefit from the LP-300 triplet regimen than other EGFR-mutant subgroups, providing a biologically and clinically compelling rationale to enrich the study for this population. Based on currently available data, preliminary multivariable Cox regression analyses incorporating race, gender, and TP53 mutation status have confirmed L858R as an independent predictor of progression-free survival benefit in the trial, suggesting the signal is not driven by demographic confounders. “The preliminary signal in the EGFR exon 21 L858R cohort — including a median progression-free survival of 8.3 months and durable responses extending beyond two years in select patients — gives us confidence that an enriched, single-arm design is the right next step. Aligning the trial with that signal, and receiving no objection from the FDA to key aspects of our approach via a successful Type C interaction, positions us to generate a more focused, decision-enabling data-set for patients, regulators, and potential partners.” — Panna Sharma, President and Chief Executive Officer, Lantern Pharma Inc. Extended LP-300 Dosing Based on Safety and Emerging Outcomes In addition to refining the molecularly defined patient population, the Type C feedback supports Lantern's proposal to increase the maximum number of LP-300 treatment cycles in HARMONIC™ from six to eight. This change is supported by historical safety data from prior clinical experience with LP-300 indicating that up to eight cycles at the current dose level did not alter the established safety profile of the drug, as well as by emerging HARMONIC™ data suggesting improved outcomes with longer LP-300 treatment duration. By extending LP-300 dosing, Lantern aims to maximize the depth and durability of response without adding clinically meaningful toxicity beyond that expected with carboplatin and pemetrexed alone. In earlier studies, LP-300 has been administered in multiple clinical trials to more than 1,000 individuals and has generally been well tolerated, providing a substantial safety foundation for this dosing adjustment. Transition to a Single-Arm, Enriched Study Design As part of the protocol amendments proposed in the Type C meeting interaction, Lantern will discontinue enrollment into the control arm of the HARMONIC™ trial and migrate the study into a single-arm design that only enrolls additional patients with the EGFR exon 21 L858R mutation. This evolution reflects the rapidly changing treatment landscape in TKI-refractory NSCLC, where increasing availability of subsequent-line therapies and patient preferences have made continued randomization to a traditional chemo-doublet control arm operationally challenging in never-smokers. The enriched, single-arm design is intended to accelerate enrollment, sharpen the clinical signal within a genomically defined subgroup, and enable more efficient comparisons to historical and real-world benchmarks in EGFR exon 21 L858R-mutant never-smoker NSCLC. Lantern anticipates that the amended design, coupled with continued integration of AI-driven insights from its RADR® platform, will support more informed discussions with regulators and prospective collaborators regarding potential registration-oriented strategies for LP-300. Differentiated Safety Profile vs. Currently Approved Post-TKI Combinations A central commercial rationale for the focused HARMONIC™ design is the differentiated safety profile of LP-300 plus chemotherapy relative to currently approved post-TKI regimens. In the recently published Phase 3 MARIPOSA-2 trial, amivantamab plus chemotherapy — now FDA-approved for EGFR-mutant NSCLC following progression on osimertinib — was associated with substantial rates of treatment-related serious adverse events, infusion reactions, and dermatologic toxicities that complicate real-world administration. Preliminary HARMONIC™ data (Data Cutoff: April 13, 2026; n=31 receiving LP-300 + chemotherapy) suggest a materially more manageable safety profile when LP-300 is added to a carboplatin/pemetrexed backbone: The table below summarizes observations regarding Treatment-Related Adverse Events (TRAE) and Treatment-Emergent Adverse Events (TEAE). A Treatment-Emergent Adverse Event in clinical trials is an unfavorable medical occurrence that starts or worsens in intensity or frequency after the first dose of study treatment. Adverse Event (any grade unless noted) LP-300 + Chemo (N=31) Amivantamab + Chemo (N=130)¹ Treatment-related serious adverse event 3% 23% TEAE leading to dose delay (any study drug) 19% 65% TEAE leading to drug discontinuation 6% 18% Infusion-related reaction (TRAE) 7% 58% Rash (TRAE) 7% 43% Paronychia (TRAE) 0% 36% Stomatitis (TRAE) 0% 31% ¹ Cross-trial comparison; not a head-to-head study. Amivantamab + chemotherapy data from Passaro A, et al. Annals of Oncology 2024;35(1):77-90 (MARIPOSA-2). LP-300 + chemotherapy data are preliminary, HARMONIC™ trial Data Cutoff: April 13, 2026. The cleaner tolerability profile is particularly relevant in the post-TKI L858R setting, where patients have already been heavily pretreated and where treatment-emergent toxicities can drive dose interruptions, premature discontinuation, and erosion of efficacy in clinical practice. Lantern believes this safety differentiation, together with the emerging efficacy signal in the L858R subgroup, positions LP-300 as a potential future best-in-tolerability option in a treatment setting that currently demands meaningful infrastructure and supportive-care resources. Ongoing Trial Progress and Emerging Clinical Data The HARMONIC™ trial is currently enrolling patients at clinical sites in the United States and Taiwan, following the completion of targeted enrollment in Japan in July 2025 across five clinical centers, including the National Cancer Center Tokyo. Taiwan represents a particularly important region for HARMONIC™, as more than half of lung cancer cases there occur in never-smokers, underscoring the global relevance of LP-300 for this patient population. The trial has already generated encouraging early clinical data: in its initial safety lead-in cohort in the United States, LP-300 in combination with carboplatin and pemetrexed demonstrated an 86% clinical benefit rate and a 43% objective response rate among the first seven patients enrolled, including one patient who achieved a durable complete response in target lesions that has now been sustained for more than two years. Additional emerging data presented in April 2026 showed a median progression-free survival of 8.3 months in EGFR exon 21 L858R-mutant patients treated with the LP-300 triplet after TKI failure, with no new safety signals and no clinically meaningful toxicity added beyond that of carboplatin and pemetrexed alone. KOL Webinar: Never-Smoker Lung Cancer – May 21, 2026 Rodman & Renshaw is hosting a fireside chat with Joseph Treat, M.D., on Thursday, May 21, 2026, from 3:00 to 4:00 PM ET, moderated by Michael G. King, Jr., Senior Biotechnology Analyst at Rodman & Renshaw. Dr. Treat is Professor Emeritus in the Division of Medical Oncology at Fox Chase Cancer Center and has focused his clinical research exclusively on lung cancer since 1991, when he founded the first medical oncology thoracic program at the University of Pennsylvania Cancer Center. His prior work as a Senior Fellow at Eli Lilly on a Phase III anti-VEGF trial in EGFR-mutated lung cancer led to regulatory approvals by the FDA, EMA, and Japanese authorities, and his current research focuses on lung cancer in individuals who have never smoked. The discussion will address the evolving treatment landscape in lung cancer, the unmet need in never-smoker populations, and what durable disease control could mean for real-world patient outcomes. To register, please click here. Lantern is actively exploring collaboration and partnering opportunities, both globally and regionally, to maximize the commercial potential of LP-300 across multiple geographies where never-smoker NSCLC is an increasingly recognized clinical challenge. The Company expects to provide additional clinical data updates from the HARMONIC™ trial, including outcomes in the enriched EGFR exon 21 L858R cohort under the amended protocol, in the second half of 2026. About LP-300 and the HARMONIC™ Trial LP-300 is an investigational small molecule being evaluated in Lantern Pharma's Phase 2 HARMONIC™ trial in combination with carboplatin and pemetrexed in never-smokers with advanced NSCLC adenocarcinoma who have progressed following treatment with EGFR tyrosine kinase inhibitors. Following a successful Type C meeting request outcome, HARMONIC™ is transitioning to a single-arm design that will enrich enrollment for patients with EGFR exon 21 L858R mutations and extend LP-300 dosing to a maximum of eight cycles. The trial is enrolling patients at clinical sites in the United States and Taiwan, with completed targeted enrollment in Japan. The HARMONIC™ trial is registered on ClinicalTrials.gov under identifier NCT05456256. LP-300 has not received FDA marketing approval for any indication. About Lantern Pharma Lantern Pharma Inc. (NASDAQ: LTRN) is a clinical-stage, AI-driven precision oncology company developing targeted therapies for high-need cancer indications. The Company's proprietary RADR® AI platform integrates multi-omic biomarker data with clinical outcomes to identify patient subgroups most likely to respond to specific therapies, enabling more efficient clinical development and biomarker-driven trial design. Lantern's pipeline includes LP-300 (HARMONIC™ trial in never-smoker NSCLC), LP-184, and LP-284, with additional preclinical programs identified through RADR®. 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 planned implementation of protocol amendments and transitioning of the study design for the HARMONIC™ clinical trial; the planned development pathway for LP-300 in patients harboring the EGFR exon 21 L858R mutation; LP-300’s potential clinical activity and tolerability profile; our clinical development plans; expectations and estimates regarding clinical trial timing and patient enrollment; estimates regarding patient populations, potential markets and potential market sizes; 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 emerging or preliminary observations in clinical studies do not ensure that later observations, studies and development will be consistent or successful, (iii) the risk that the planned development of LP-300 for treatment of patients harboring the EGFR exon 21 L858R mutation may not be successful, (iv) the risk that any clinical benefit observed to date relating to LP-300 may not be reproduced in the completed HARMONIC™ trial or in larger or confirmatory studies, (v) the risk that clinical data referenced in this press release are exploratory and preliminary, based on small patient cohorts, and may not be representative of outcomes in broader populations, (vi) the risk that cross-trial comparisons are provided for context only and should not be interpreted as direct evidence of comparative safety or efficacy, (vii) the risk that our research and the research of our collaborators may not be successful, (viii) the risk that we may not be successful in licensing our product candidates or in completing potential partnerships and collaborations, (ix) 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, and (x) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 30, 2026. You may access our Annual Report on Form 10-K for the year ended December 31, 2025, under the investor SEC filings tab of our website at www.lanternpharma.com or on the SEC’s website at www.sec.gov. Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations. View source version on businesswire.com: https://www.businesswire.com/news/home/20260519628990/en/ Investor & Media Contact
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US Market News
1月前
Lantern Pharma Reports First Quarter 2026 Financial Results and Provides Business UpdatesMay 15, 2026 4:01 PM
Business Wire Disciplined 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. 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. The 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. “The 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.” In 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. “withZeta.ai 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.” 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 $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. LP-300 HARMONIC™ Trial: Successful Type C Meeting Request Outcome and Path Forward In 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. The 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. 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 second 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 $4 billion annually. Currently, there are no therapies specifically approved for never-smoker NSCLC patients. Starlight Therapeutics: FDA IND Clearance for Pediatric CNS Cancer Trial and Expanded Adult GBM Program In 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 tumors. These 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. In 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. Glioblastoma 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. withZeta.ai: Commercial Launch & Evolution Towards An Independent Entity In 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. withZeta.ai 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. Planned Separation into an Independent Business Entity In 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. This 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 platform business addressing the multi-billion-dollar opportunity in AI-enabled drug discovery and cancer research. Lantern believes that withZeta.ai is positioned at the intersection of two high-growth markets — the global rare disease therapeutics market, and the broader AI-enabled drug discovery and pharmaceutical R&D outsourcing market. Analysts estimate that the AI-enabled outsourcing and platform market for pharmaceutical companies will be in the range of $20 to $30 billion by 2030. Lantern plans to host a dedicated investor webinar during the first half of June 2026 to provide additional detail on the withZeta.ai platform’s commercial trajectory, the contemplated independent business entity, the strategic rationale for the planned separation, and anticipated next steps. Registration details will be communicated through the Company’s investor relations channels in advance of the webinar. predictBBB.ai: Evolution into a Molecular Intelligence Web Service Powered by a Large Quantitative Model During the first quarter of 2026, Lantern completed a major expansion of predictBBB.ai, repositioning the platform from a focused blood-brain barrier permeability prediction tool into a first-of-its-kind molecular intelligence web service powered by a Large Quantitative Model (LQM). The expanded platform extends beyond BBB permeability prediction to a broader set of molecular and structural analyses designed to accelerate small molecule drug design and optimization for CNS and non-CNS indications alike. The underlying LQM architecture is purpose-built for the prediction of quantitative molecular properties — including permeability, solubility, binding affinity, metabolic stability, and structural similarity — across a wide range of therapeutic chemistry contexts. By moving from a single-property predictor to a multi-property intelligence service, predictBBB.ai is now positioned to serve a broader user base of medicinal chemists, computational scientists, and translational researchers working across oncology, neurology, and other therapeutic areas. predictBBB.ai continues to demonstrate industry-leading performance benchmarks, holding five of the top eleven positions on the Therapeutic Data Commons Leaderboard for blood-brain barrier permeability prediction, with the lead model achieving 94.1% accuracy. The platform is accessible through a web-based service interface designed for ease of use by both individual researchers and enterprise drug discovery teams. The repositioning of predictBBB.ai complements Lantern’s broader AI platform strategy alongside the RADR® platform and withZeta.ai, reinforcing the Company’s position as a creator and innovator of differentiated, oncology- and rare-disease-focused AI infrastructure for global biopharma drug development. Financial Results for the First Quarter Ended March 31, 2026 Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $6.3 million as of March 31, 2026 (consisting of approximately $4.9 million in cash and cash equivalents and approximately $1.4 million in marketable securities), compared to approximately $10.1 million as of December 31, 2025. The Company received gross proceeds of approximately $4.4 million in a registered direct offering that closed on May 14, 2026. The Company believes its cash, cash equivalents, and marketable securities on hand, including the net proceeds from the offering, will fund anticipated operating expenses and capital expenditure requirements until approximately the middle of the first quarter of 2027. Research and Development Expenses: R&D expenses were approximately $1.7 million for the three months ended March 31, 2026, compared to approximately $3.3 million for the three months ended March 31, 2025, a decrease of approximately $1.5 million or 47%. The decrease was primarily attributable to reductions of approximately $1,322,000 in research studies and materials relating to the conduct of our clinical trials and decreases of approximately $246,000 in salaries and benefit expenses. General and Administrative Expenses: G&A expenses were approximately $1.7 million for the three months ended March 31, 2026, compared to approximately $1.5 million for the three months ended March 31, 2025, an increase of approximately $170,000 or 11%. The increase was primarily attributable to increases in patent costs of approximately $99,000, salaries and benefit expense increases of approximately $71,000, and business development and investor relations expenditure increases of approximately $36,000. Net Loss: Net loss was approximately $3.3 million (or $0.30 per share) for the three months ended March 31, 2026, compared to a net loss of approximately $4.5 million (or $0.42 per share) for the three months ended March 31, 2025, representing a year-over-year reduction of approximately $1.2 million or 27%. Capitalization: As of May 12, 2026, the Company had 11,304,697 shares of common stock outstanding. On May 14, 2026, the Company closed a registered direct offering and concurrent private placement comprising 1,454,175 shares of common stock, pre-funded warrants to purchase up to 681,748 shares of common stock, and unregistered warrants to purchase up to 2,135,923 additional shares of common stock at an exercise price of $2.27 per share. The warrants are exercisable beginning six months after issuance and expire five years from the initial exercise date. 2026 Corporate Objectives and Catalysts Second Half 2026: Additional clinical data readouts from the Phase 2 HARMONIC™ trial following implementation of the protocol amendments focusing enrollment on EGFR exon 21 L858R never-smoker NSCLC patients. First Half of June 2026: Dedicated investor webinar on withZeta.ai commercial trajectory, the contemplated independent business entity, and the strategic rationale for the anticipated benefits of the planned separation. 2026: Investigator-led clinical study initiation in Denmark for LP-184 in PTGR1-overexpressing bladder cancers with DNA damage repair mutations. 2026: Execution of the strategic plan to create an independent business entity composed of withZeta.ai assets and related technologies, including announcement of additional structural and listing details. 2026: Planned initiation of additional clinical trials for LP-184 and STAR-001. 2026: Continued commercialization of the withZeta.ai multi-agentic co-scientist platform, including conversion of demo and evaluation engagements to commercial subscription contracts and expansion across the rare cancer research community. 2026: Continued scale-up of the AI Center of Excellence in India to industrialize the RADR® platform and withZeta.ai system and accelerate global biopharma development opportunities. 2026: Pursuit of additional funding, including potential grant revenue, partnership transactions, and additional capital raises, to support planned operations and clinical advancement. About Lantern Pharma Lantern Pharma (NASDAQ: LTRN) is an AI-driven company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 200 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development and generate oncology medicines at dramatically reduced costs and accelerated timelines. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of drug candidates that span multiple cancer indications, including both solid tumors and blood cancers and an antibody-drug conjugate (ADC) program. 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. Our lead development programs include a Phase 2 clinical program in never-smoker and non-smoker NSCLC, planned Phase 1b/2 trials in biomarker-defined solid tumors, and an ongoing Phase 1 program in hematologic malignancies and adult soft tissue sarcomas. 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. In April 2026, Lantern publicly launched withZeta.ai, the first multi-agentic AI co-scientist platform purpose-built for rare and complex cancer drug development. Our AI-driven pipeline of innovative product candidates is estimated to have a combined annual market potential of over $15 billion USD. 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; the planned separation of withZeta.ai into an independent business entity and the anticipated benefits of such separation; the planned investor webinar regarding withZeta.ai; estimates regarding the development timing for our drug candidates, AI platforms, and ADC development program; expectations and estimates regarding clinical trial timing and patient enrollment; the use of proceeds from the May 2026 registered direct offering and the expected time that our cash, cash equivalents and marketable securities will allow us to fund our operations; the potential exercise of warrants issued in the May 2026 concurrent private placement; our research and development efforts of our internal drug discovery programs and the utilization of our AI platforms 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 existence of substantial doubt about our ability to continue as a going concern in the absence of obtaining substantial additional funding, (ii) 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, (iii) 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, (iv) the risk that our research and the research of our collaborators may not be successful, (v) the risk that we may not be successful in licensing potential candidates or in completing potential partnerships and collaborations, (vi) 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, (vii) the risk that no drug product based on our proprietary AI platforms has received FDA marketing approval or otherwise been incorporated into a commercial product, (viii) the risk that our AI platform commercialization efforts, including withZeta.ai, may not generate the anticipated revenue or achieve the expected market adoption, (ix) the risk that the planned separation of withZeta.ai may not be completed on the contemplated terms or timeline or at all, and (x) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 30, 2026 and in the Quarterly Report on Form 10-Q for the quarter ended March 31, 2026. You may access our Annual Report on Form 10-K for the year ended December 31, 2025 and our Quarterly Report on Form 10-Q for the quarter ended March 31, 2026 under the investor SEC filings tab of our website at www.lanternpharma.com or on the SEC’s website at www.sec.gov. Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations. Lantern Pharma Disclosure Channels to Disseminate Information Lantern Pharma’s investors and others should note that we announce material information to the public about our company through a variety of means, including our website, press releases, SEC filings, digital newsletters, and social media, in order to achieve broad, non-exclusionary distribution of information to the public. We encourage our investors and others to review the information we make public in the locations above as such information could be deemed to be material information. Please note that this list may be updated from time to time. View source version on businesswire.com: https://www.businesswire.com/news/home/20260515994237/en/ Investor Contact
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1月前
Lantern Pharma Inc. Announces Closing of up to $9.25 Million Registered Direct Offering with Existing Holders and a Single Institutional InvestorMay 14, 2026 4:05 PM
Business Wire $4.4 million upfront with up to an additional $4.85 million of potential aggregate gross proceeds upon the exercise in full of the warrants Offering priced at the closing price with unregistered warrants exercisable at a 10% premium to the close and non-exercisable for the first six months Lantern Pharma Inc. (NASDAQ: LTRN) (“Lantern” or the “Company”), a clinical-stage AI-driven precision oncology company developing targeted and transformative cancer therapies using its proprietary AI and machine learning platforms with multiple clinical stage drug programs, today announced the closing of its previously announced registered direct offering of 2,135,923 shares of its common stock (or pre-funded warrants in lieu thereof) at a purchase price of $2.06 per share (or pre-funded warrant in lieu thereof). In addition, in a concurrent private placement, the Company issued unregistered warrants to purchase up to 2,135,923 shares of common stock. The warrants have an exercise price of $2.27 per share, are exercisable six months following the initial issuance date, and will expire five years following the initial exercise date. Rodman & Renshaw LLC acted as the exclusive placement agent for the offering. The aggregate gross proceeds to the Company from the offering were approximately $4.4 million, before deducting the placement agent fees and other offering expenses payable by the Company. The potential additional gross proceeds from the unregistered warrants, if fully exercised on a cash basis, will be approximately $4.85 million. No assurance can be given that any of the warrants will be exercised. The Company currently intends to use the net proceeds from the offering for working capital and other general corporate purposes. The shares of common stock (or pre-funded warrants in lieu thereof) (but not the warrants issued in the private placement or the shares of common stock underlying such warrants) were offered by the Company pursuant to a “shelf” registration statement on Form S-3 (File No. 333-279718) filed with the Securities and Exchange Commission (“SEC”) on May 24, 2024, and became effective on June 10, 2024. The registered direct offering of the shares of common stock (or pre-funded warrants in lieu thereof) was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. The prospectus supplement and the accompanying prospectus relating to the shares of common stock (or pre-funded warrants in lieu thereof) offered in the registered direct offering were filed with the SEC and are available at the SEC’s website at www.sec.gov. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the registered direct offering may also be obtained by contacting Rodman & Renshaw LLC at 600 Lexington Avenue, 32nd Floor, New York, NY 10022, by telephone at (212) 540-4414, or by email at info@rodm.com. The warrants described above were issued in a concurrent private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Securities Act”), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Securities Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction. About Lantern Pharma Lantern Pharma (NASDAQ: LTRN) is a clinical-stage AI-driven precision oncology company transforming the cost, pace, and timeline of oncology drug discovery and development. The company’s proprietary AI and machine learning platform, RADR®, now operationalized through withZeta.ai, leverages billions of data points and advanced computational methods to rapidly uncover biomarker signatures and accelerate the development of targeted oncology therapies for difficult-to-treat cancers, including those of the central nervous system. Lantern is currently advancing a pipeline of small molecule drug candidates and an antibody-drug conjugate program focused on multiple solid tumor and hematologic malignancies. For more information, visit: www.lanternpharma.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 the use of proceeds from the offering and the exercise of the warrants prior to their expiration. 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 the Company may not be able to secure sufficient future funding when needed and as required to advance and support our existing and planned development programs 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 our AI platform commercialization efforts, including withZeta.ai, may not generate the anticipated revenue or achieve the expected market adoption, (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 AI platforms has received FDA marketing approval or otherwise been incorporated into a commercial product, (vii) market and other conditions, and (viii) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 30, 2026. You may access our Annual Report on Form 10-K for the year ended December 31, 2025 under the investor SEC filings tab of our website at http://www.lanternpharma.com/ or on the SEC’s website at http://www.sec.gov/. Given these risks and uncertainties, the Company can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and the Company cautions investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, the Company disclaims any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations. View source version on businesswire.com: https://www.businesswire.com/news/home/20260514640528/en/ Investor Contact
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1月前
Lantern Pharma to Report First Quarter 2026 Operating & Financial Results on May 15th, 2026May 11, 2026 4:30 PM
Business Wire Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage AI-driven precision oncology company developing targeted and transformative cancer therapies using its proprietary AI and machine learning platforms with multiple clinical stage drug programs, today announced that it will report its first quarter 2026 operating and financial results via press release to be issued on Friday, May 15. The press release will discuss financial results for the first quarter ended March 31, 2026 and provide operational updates on clinical trials and the development of the Company’s AI platforms. About Lantern Pharma Lantern Pharma (NASDAQ: LTRN) is a clinical-stage AI-driven precision oncology company transforming the cost, pace, and timeline of oncology drug discovery and development. The company’s proprietary AI and machine learning platform, RADR®, now operationalized through withZeta.ai, leverages billions of data points and advanced computational methods to rapidly uncover biomarker signatures and accelerate the development of targeted oncology therapies for difficult-to-treat cancers, including those of the central nervous system. Lantern is currently advancing a pipeline of small molecule drug candidates and an antibody-drug conjugate program focused on multiple solid tumor and hematologic malignancies. For more information, visit www.lanternpharma.com. For more information, visit: Website: www.lanternpharma.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 AI platforms in identifying drug candidates and patient populations that are likely to respond to a drug candidate; our strategic plans to advance the development of our drug candidates, AI platforms, and antibody drug conjugate (ADC) development program; estimates regarding the development timing for our drug candidates, AI platforms, and ADC development program; potential partnerships and collaborations; 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 AI platforms 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; 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 development programs 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 our AI platform commercialization efforts, including withZeta.ai, may not generate the anticipated revenue or achieve the expected market adoption, (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 AI platforms has received FDA marketing approval or otherwise been incorporated into a commercial product, and (vii) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 30, 2026. You may access our Annual Report on Form 10-K for the year ended December 31, 2025 under the investor SEC filings tab of our website at http://www.lanternpharma.com/ or on the SEC’s website at http://www.sec.gov/. Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations. View source version on businesswire.com: https://www.businesswire.com/news/home/20260511997550/en/ Investor Contact
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2月前
Lantern Pharma’s predictBBB.ai Evolves Into a Real-Time Large Quantitative Model (LQM) for Precision Molecular Intelligence — Comprehensive Small Molecule Characterization & Development Analytics Available as a Web Service to Drug Developers GloballyApril 29, 2026 8:50 AM
Business Wire
360-Degree Small-Molecule Developability Profiling from a Single SMILES String in Seconds by characterizing and calculating 99 critical molecular features
Capabilities are Fully Integrated into withZeta.ai® for Rare Cancer Drug Development
Seeking Early Collaborations with Pharma Partners to Integrate Molecular Intelligence into Discovery Workflows
Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biotechnology company advancing precision oncology through its proprietary RADR® AI platform, today announced the expansion of predictBBB.ai into a Large Quantitative Model (LQM) — a real-time quantitative intelligence engine now accessible to any researcher or drug development team, anywhere in the world, through a single browser interface.
For the first time, pharmaceutical scientists and medicinal chemists can access a unified, benchmark-validated LQM — not as a batch software installation, not as a siloed cheminformatics tool — but as an on-demand molecular intelligence engine delivered as a web service. By submitting a single SMILES string, users receive a comprehensive, 360-degree developability profile of any small molecule in seconds: a capability that previously required hours of computation across multiple platforms and specialized bioinformatics personnel to integrate — removing the computational barriers that have historically limited rigorous molecular characterization to large, well-resourced pharmaceutical organizations, and making that same analytical power available to biotech innovators, academic drug hunters, and rare disease programs worldwide.
What Is a Large Quantitative Model — and Why Does It Matter?
Unlike Large Language Models trained on patterns in text, a Large Quantitative Model is trained on the quantitative language of science itself. The predictBBB™ LQM was built on thousands of characterized drug candidates and small molecules, with their physicochemical properties (thousands of properties or features for each molecule) encoded as vector representations and molecular fingerprints. This architecture enables simultaneous, high-dimensional property prediction at computational speeds orders of magnitude faster than conventional cheminformatics workflows — while preserving the scientific rigor of chemistry-grounded modeling.
The result is a system that does not approximate molecular behavior from literature patterns. It calculates it, in real time, from the underlying quantitative structure of matter — capable of screening tens of thousands of molecules per day through a single, unified web interface. No installation. No data integration overhead. No specialized infrastructure required.
Benchmark-Validated Performance — and a Continued Commitment to Improvement
Lantern’s BBB permeability algorithms were contributed to the Therapeutic Data Commons (TDC) leaderboard — one of the most rigorous open benchmarking platforms in computational drug discovery — where five of Lantern’s algorithms rank among the top 12 by accuracy and predictive performance. Since that contribution, Lantern has continued to refine and improve the underlying models, with performance advances beyond what is currently reflected on the public leaderboard. The TDC ranking represents a validated baseline — the current state of the platform exceeds it.
A Unified Molecular Intelligence Panel — Delivered in Seconds
The predictBBB™ LQM expands far beyond its origins as a blood-brain barrier permeability predictor. By submitting a single SMILES string through the web interface, researchers receive an exhaustive molecular profile across four integrated dimensions:
Physicochemical Overview: Instant calculation of lipophilicity (logP), polar surface area (TPSA), molecular weight, and ionization state — the properties that determine whether a molecule can reach its target, survive in circulation, and penetrate the right biological membranes.
Comprehensive Drug-Likeness: An integrated scoring panel combining Lipinski’s Rule of Five with four additional developability assessments — flagging bioavailability liabilities, metabolic vulnerabilities, and toxicity risk before a molecule ever reaches the lab.
Structural Architecture: Real-time calculation of 25 molecular descriptors covering electronic distribution and functional group composition — enabling chemists to identify which parts of a molecule will be metabolically degraded and to engineer those weaknesses out at the design stage.
Topological Mapping: Quantification of molecular shape, size, and branching complexity to support Structure-Activity Relationship (SAR) modeling — ensuring a candidate’s three-dimensional architecture is optimized to fit its intended protein target.
Beyond the BBB: A Universal Engine for All of Small-Molecule Drug Discovery
The name predictBBB.ai reflects where this platform was born — but not the boundaries of what it can do.
While CNS drug development demands exceptionally tight physicochemical control for blood-brain barrier penetration, the underlying calculations are the fundamental parameters of all small-molecule drug design. For non-CNS programs, the platform’s utility is arguably broader: the acceptable physicochemical envelope for peripheral targets is wider, and the ability to predict oral bioavailability, P-glycoprotein efflux, intestinal absorption, and hepatic metabolic clearance in real time is equally critical across oncology, cardiovascular medicine, and rare disease indications.
The platform’s transporter models — including P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP) predictions — carry particular strategic value in oncology, where tumor overexpression of efflux pumps is a well-established driver of chemotherapeutic resistance. Identifying substrate liability at the molecular design stage, before physical synthesis, is a material competitive advantage that the predictBBB™ web service now makes accessible without infrastructure barriers.
This positions predictBBB.ai as a universal early-stage decision platform — applicable from CNS programs to kinase inhibitors in oncology to novel chemical entities for rare disease indications — and as the first web-native molecular intelligence service of its class grounded in independently benchmarked, quantitative model performance.
“predictBBB.ai began as a CNS permeability predictor — what it has evolved into is a quantitative intelligence engine that speaks the universal language of medicinal chemistry, now accessible to any drug developer in the world as a web service. Five of our core algorithms rank among the top 12 on the Therapeutic Data Commons leaderboard — that is a measurable scientific standard, not a marketing claim — and our team has continued to advance the platform well beyond that baseline. The earliest decisions in a program are the most consequential ones, and we are inviting partners to integrate this capability and work with us to redefine what rational drug design looks like at scale. Developing and making available ground-breaking computational and AI tools for drug development has the potential to introduce new therapies and cures for patients at a velocity that is needed in medicine.”
— Panna Sharma, Chief Executive Officer, Lantern Pharma Inc.
Strategic Integration with withZeta.ai
The predictBBB LQM is fully integrated into Lantern’s withZeta.ai® multi-agentic AI co-scientist platform, where it directly addresses a persistent challenge in rare oncology: the absence of large historical datasets makes rational, fail-fast molecular design not a preference but a necessity. Within withZeta.ai, the platform enables Lantern and its partners to architect candidates optimized simultaneously for target potency and pharmacokinetic viability — compressing analytical workflows that previously required days of iterative computation into seconds, and embedding that intelligence directly into the broader co-scientist ecosystem.
Part of a Growing Portfolio of Commercially Leverageable AI Assets
The expanded predictBBB LQM represents the latest addition to Lantern Pharma’s growing portfolio of proprietary AI technologies developed for drug discovery — a portfolio that includes the RADR® genomic intelligence platform and the withZeta.ai® multi-agentic co-scientist ecosystem. Consistent with Lantern’s strategy of building AI assets with both internal pipeline and external commercial value, the Company intends to leverage and monetize these capabilities through partnerships, licensing arrangements, and direct platform access — creating potential revenue streams that complement its clinical development programs.
Collaboration Opportunities and a Subscription-Based Roadmap
Lantern Pharma is actively inviting pharmaceutical companies and biotech innovators to explore early integration of the predictBBB™ LQM web service into their existing discovery workflows. The platform is particularly well-suited for organizations with active small-molecule programs in oncology, CNS, or rare disease seeking to compress hit-to-lead and lead optimization cycle times, reduce dependence on fragmented computational infrastructure, and implement a rigorous, benchmark-validated developability screen at the earliest stages of candidate selection. API-level access for enterprise integration into partner computational pipelines is in active development. Interested organizations are invited to contact Lantern’s business development team to initiate a conversation.
This release marks an early milestone in a broader product roadmap for predictBBB.ai. Additional molecular intelligence features and predictive models are planned for integration in the coming months, with the platform expected to launch as part of a subscription-based service for scientists and drug developers globally. Lantern intends for this service to be accessible to the full spectrum of the drug development community — from individual medicinal chemists and academic researchers to enterprise pharmaceutical teams — establishing predictBBB.ai as an ongoing, commercially scalable AI platform asset.
About predictBBB.ai
predictBBB.ai is an AI-powered molecular developability web service developed by Lantern Pharma — the first platform of its class to deliver real-time, unified physicochemical and structural characterization of small molecules through a browser-accessible interface, without specialized infrastructure requirements. Capable of processing tens of thousands of compounds per day, the platform’s core algorithms are independently benchmarked on the Therapeutic Data Commons (TDC) leaderboard, with five algorithms ranking among the top 12 for BBB permeability prediction by accuracy and performance. Additional features and predictive models are planned for integration in the coming months as part of a broader subscription-based service launch. predictBBB.ai is fully integrated within the withZeta.ai® multi-agentic co-scientist ecosystem.
About Lantern Pharma Inc.
Lantern Pharma Inc. (NASDAQ: LTRN) is a clinical-stage biotechnology company using its proprietary RADR® AI platform and withZeta.ai® multi-agentic AI co-scientist to transform the speed, cost, and precision of oncology drug development. Lantern’s pipeline includes LP-184, LP-284, LP-300 (HARMONIC trial), and STAR-001, developed through its wholly owned CNS subsidiary, Starlight Therapeutics. For more information, visit www.lanternpharma.com.
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 December 31, 2025, filed with the Securities and Exchange Commission on March 30, 2026.
You may access our Annual Report on Form 10-K for the year ended December 31, 2025 under the investor SEC filings tab of our website at www.lanternpharma.com or on the SEC’s website at www.sec.gov. Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations.
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2月前
Lantern Pharma to Debut Public Demonstration of withZeta.ai - A Platform to Conquer Rare Cancers on April 30 Following AACR 2026 Scientific DebutApril 24, 2026 7:50 AM
Business Wire
CEO Panna Sharma to Lead Live, Unscripted Platform Walkthrough in Two Interactive Sessions on April 30, 2026 — Open to Investors, Researchers, and the Global Biomedical Community
Registration Link & Details Can be Accessed Below
Lantern Pharma Inc. (NASDAQ: LTRN) (“Lantern” or the “Company”), an AI-driven clinical-stage precision oncology company, today announced the first public demonstration of withZeta.ai, its multi-agentic AI co-scientist platform, to be held on Thursday, April 30, 2026. The event follows the platform's scientific community debut at the American Association for Cancer Research (AACR) Annual Meeting 2026 and its initial unveiling at Nasdaq MarketSite — and marks the first time the platform will be demonstrated live and without restriction to a global public audience of investors, researchers, and industry participants.
President and Chief Executive Officer Panna Sharma will lead the demonstration in real time — live, interactive, and unrehearsed — showing how withZeta.ai operates as a genuine AI co-scientist at the frontier of oncology drug discovery. Two identical sessions will be held to accommodate global time zones:
Morning Session: 8:30 AM ET — Register Here
Afternoon Session: 4:30 PM ET — Register Here
Each session will include a live platform walkthrough followed by an open Q&A with management.
From Scientific Validation to Public Stage
withZeta.ai made its scientific debut at AACR 2026 — one of the world's most rigorous forums for oncology and translational research — and was first unveiled at Nasdaq MarketSite, a globally recognized venue at the intersection of capital markets and innovation. April 30th represents a deliberate next step: opening the platform to the full public for the first time, with no gatekeeping, no curated excerpts, and no pre-recorded footage.
Attendees will watch in real time as the platform executes complex research workflows — synthesizing clinical, molecular, and scientific datasets simultaneously to generate insights and compress research timelines that historically required months of manual effort. This is not a product marketing event. It is a transparency event, and the platform will speak for itself.
A Platform Built for the Economics and Urgency of Rare Cancer
With the AI-driven drug discovery market projected to surpass $15 billion by 2030 and growing at over 30% annually, the industry is in the early stages of a structural transformation. Yet rare cancers remain the discipline's most persistent blind spot — historically neglected not for lack of scientific interest, but because the economics and timelines of traditional development make them commercially unattractive.
withZeta.ai was purpose-built to close that gap. The platform integrates:
A proprietary rare cancer ontology spanning hundreds of cancer subtypes, structuring biological knowledge in a form that AI agents can actively reason across — not merely retrieve.
Multi-database querying across clinical trial registries, biomedical literature, and molecular datasets — simultaneously and in real time, not sequentially.
Advanced generative AI models for molecular design, ADMET prediction, blood-brain barrier permeability analysis, and structure-activity relationship (SAR) evaluation — capabilities embedded in the platform’s Ether0 generative chemistry architecture.
A scalable, subscription-based commercial model — with introductory, academic, and enterprise tiers — representing a non-dilutive, recurring revenue stream accessible to any researcher, institution, or biopharma organization globally.
Following its debut at Nasdaq MarketSite and AACR 2026, Lantern is advancing withZeta.ai as both a scientific accelerator and a commercial growth engine — one that creates value for rare cancer patients, for research institutions, and for Lantern shareholders simultaneously.
“The rarest cancers have always faced the longest waits — not because the science is absent, but because the infrastructure to move at the speed of urgency has never existed. withZeta.ai changes that. It is not a search engine, not a literature tool, and not a chatbot with oncology data loaded in. It is a multi-agentic AI-powered co-scientist, forged from years of real clinical development, careful curation of knowledge-bases and exquisite disease models. It is capable of executing research workflows and drug development decision making and assessment in real time - things that would otherwise take months or longer. On April 30th, we are inviting the world to see it operate — live, unrehearsed, and without restriction.”
— Panna Sharma, President and Chief Executive Officer, Lantern Pharma Inc.
Webinar Access Details
Date: Thursday, April 30, 2026
Morning Session: 8:30 AM ET
Registration: Register for Morning Session
Afternoon Session: 4:30 PM ET
Registration: Register for Afternoon Session
Subscribe Now: withZeta.ai
ABOUT LANTERN PHARMA INC.
Lantern Pharma Inc. (Nasdaq: LTRN) is a clinical-stage precision oncology company leveraging AI, machine learning, and its proprietary RADR® platform to transform the development of cancer therapies. Lantern’s clinical pipeline includes LP-184 (acylfulvene), LP-284 (a TC-NER targeting compound in hematologic cancers and sarcomas), and LP-300 which is being evaluated in the HARMONIC Phase 2 trial in never-smoker patients with relapsed advanced lung adenocarcinoma following TKI treatment. LP-184 is also being developed as STAR-001 for pediatric and adult CNS cancers through Starlight Therapeutics, Lantern’s wholly owned CNS-focused subsidiary. withZeta.ai, Lantern’s multi-agentic AI co-scientist platform, is now commercially available as a subscription-based research platform for the global biomedical and drug development community, representing a new revenue stream for the Company. Lantern operates an AI Center of Excellence in Bengaluru, India and is headquartered in Dallas, Texas.
ABOUT withZeta.ai
withZeta.ai is redefining how rare cancer research, discovery, drug development, and clinical trial design gets done. Knowledge work in oncology is migrating to AI co-scientists — autonomous systems that investigate, reason, and synthesize across the full breadth of scientific evidence. withZeta.ai is that co-scientist: purpose-built for the biology, economics, and urgency of rare cancer drug development, and accessible to any researcher, anywhere. Built by Lantern Pharma (Nasdaq: LTRN). Learn more and subscribe at withZeta.ai.
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 December 31, 2025, filed with the Securities and Exchange Commission on March 30, 2026.
You may access our Annual Report on Form 10-K for the year ended December 31, 2025 under the investor SEC filings tab of our website at www.lanternpharma.com or on the SEC’s website at www.sec.gov. Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations.
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2月前
Emerging Data for Lantern Pharma’s Investigational Drug LP-300 Demonstrates 8.3-Month Median Progression-Free Survival in Patients with EGFR L858R Lung Cancer After Targeted Therapy Failure — With No Added ToxicityApril 20, 2026 8:05 AM
Business Wire
Lantern Pharma Schedules Type C Meeting with the FDA to Advance HARMONIC™ Protocol Amendments Targeting This High-Need Population, Reflecting LP-300’s Novel Mechanism of Action and the Rapidly Evolving Post-TKI Standard of Care
Among L858R patients in HARMONIC™, those who completed 6 doses or cycles of LP-300 demonstrated a higher median PFS than the overall L858R cohort and those patients that had only 4 doses or cycles of LP-300
Lantern Pharma Inc. (NASDAQ: LTRN), an AI-driven precision oncology company, today announced it has scheduled a Type C meeting with the U.S. Food and Drug Administration (FDA) for mid-May 2026 to seek feedback on proposed protocol amendments to its ongoing Phase 2 HARMONIC™ clinical trial evaluating LP-300. The amendments are grounded in emerging clinical data demonstrating a meaningful and consistent progression-free survival signal in patients with EGFR Exon 21 L858R-mutant non-small cell lung cancer (NSCLC) who have progressed following any TKI-based treatment (including osimertinib) — a population carrying a particularly poor prognosis and limited remaining therapeutic options. Lantern is seeking the FDA’s scientific guidance to sharpen the trial design around the patients most likely to benefit, and to pursue the most rigorous and efficient development path possible.
Emerging Clinical Evidence: A Consistent and Coherent Signal
Preliminary clinical data from the HARMONIC™ trial, with a data cutoff of April 13, 2026, have revealed a differentiated and consistent progression-free survival profile for LP-300 in patients harboring the EGFR Exon 21 L858R mutation — accounting for approximately 40% of all EGFR-mutant NSCLC cases globally, and a subgroup with a notably inferior prognosis following frontline TKI (including osimertinib) therapy compared with Exon 19 deletion patients. Among the 16 L858R-mutant patients enrolled in HARMONIC™, LP-300 in combination with carboplatin and pemetrexed demonstrated:
8.3 mo
mPFS — L858R Patients
n=16 | 95% CI: 6.2–NC
86% / 43%
Clinical Benefit Rate / ORR
Safety Lead-In Cohort (US)
HR 0.37
L858R vs. Non-L858R
95% CI: 0.15–0.89
~$4B+
Annual Market Opportunity
L858R-enriched never-smoker NSCLC
These outcomes were observed in patients who had already progressed on tyrosine kinase inhibitor (TKI) therapy — a setting where prognosis is particularly challenging and where treatment tolerability is a critical consideration. The upper confidence interval for mPFS (median progression-free survival) for the L858R patient group remains not calculable at the time of analysis, suggesting that a meaningful proportion of patients may be achieving disease control that extends substantially beyond the reported median. The Hazard Ratio (HR) observations to date for the L858R patient group are also encouraging.
Independent Statistical Signal: Multivariable Analysis
To assess whether the emerging L858R efficacy signal might be explained by other patient characteristics, a multivariable Cox regression analysis was conducted incorporating race, gender, and TP53 mutation status. The L858R mutation remained a statistically significant independent predictor of progression-free survival across all models tested:
After adjusting for race and gender: HR 0.36 (95% CI: 0.15–0.90, p=0.028) — no significant associations were observed for race or gender alone
After incorporating TP53 mutation status: HR 0.23 (95% CI: 0.06–0.91, p=0.036) — L858R effect remained significant
These analyses are exploratory and based on a small patient cohort. Lantern plans to support these findings with additional data from the ongoing HARMONIC™ trial as enrollment and patient monitoring continues.
Durable Clinical Benefit: Depth and Persistence of Response
Beyond the overall L858R progression-free survival signal, exploratory analyses from the HARMONIC™ trial reveal several findings that further support the depth and durability of LP-300’s activity in this patient population.
Dose-Duration Signal: More Cycles, Better Outcomes
Among L858R patients in HARMONIC™, those who completed 6 doses or cycles of LP-300 demonstrated a higher median PFS than the overall L858R cohort:
L858R patients completing 6 cycles of LP-300 showed a mPFS = 8.9 months (n=9, 3 patients had not yet progressed at the time of analysis)
Comparable safety profiles were observed across patients receiving 4 or 6 cycles, with no evidence of increased adverse events with longer treatment duration
This dose-duration trend is consistent with LP-300’s kinase inhibitory mechanism of action and provides supporting scientific rationale for the proposed extension of maximum treatment cycles from 6 to 8. These data are exploratory and based on small patient numbers; Lantern expects to further characterize this relationship as the trial continues.
Heavily Pretreated Patients: A Notable Signal in a Difficult Setting
Among the subset of L858R patients who had received two prior lines of systemic therapy — a particularly challenging population to treat — an encouraging preliminary signal was observed:
L858R patients with 2 prior systemic therapies: mPFS = 13.5 months (n=5; 3 patients had not yet progressed at the time of analysis)
One patient in this cohort achieved a durable complete response in target lesions, with survival continuing beyond two years. Notably, this patient’s response deepened over time, progressing from an initial partial response to a confirmed complete response — a pattern consistent with an ongoing and evolving treatment effect.
These data represent a very small patient subset and should be interpreted with appropriate caution. Individual patient outcomes may not be representative of the broader population. These findings are hypothesis-generating and will require confirmation in larger cohorts.
Why L858R — and Why Does It Matter?
The Scientific Rationale: Why LP-300 May Be Uniquely Suited to L858R
The L858R substitution replaces leucine — a hydrophobic amino acid — with positively charged arginine, disrupting the hydrophobic interactions that normally stabilize the EGFR kinase domain in its inactive conformation. The result is a receptor that preferentially adopts the active state. Critically, however, unlike Exon 19 deletion mutants — where the shortened aC-helix locks the receptor into a stable, monomer-capable active orientation — L858R tumors still require receptor dimerization to complete oncogenic activation and transformation.
This significant mechanistic distinction represents the structural basis for L858R’s unique vulnerability to dimerization interference. LP-300 is a disulfide-active small molecule whose metabolites, generated in the pericellular space, form covalent adducts with exposed cysteine residues on target proteins. The EGFR extracellular domain contains 50 cysteine residues forming 25 disulfide bonds — a structurally dense region that includes the dimerization arm through which EGFR receptors make receptor-to-receptor contact during the dimerization process. LP-300’s covalent activity at this extracellular interface provides a plausible mechanistic basis for disrupting dimerization itself, independent of the intracellular ATP-binding pocket where all currently approved EGFR inhibitors act.
These observations offer a coherent scientific hypothesis for the selectivity observed in the HARMONIC™ study: L858R tumors uniquely require dimerization for activation; LP-300’s covalent mechanism operates at the extracellular interface where that dimerization occurs; and the consequent attenuation of dimerization-driven signaling would be expected to selectively disadvantage L858R tumors in a manner that Exon 19 deletion tumors — which activate independently of dimerization — would not experience.
Lantern acknowledges this remains a mechanistic hypothesis requiring further experimental validation. The Company intends to incorporate mechanistic and advanced liquid biopsy studies within the amended HARMONIC™ protocol to further characterize this relationship as the trial advances.
Three Proposed Protocol Amendments
The following protocol amendments are being proposed to the FDA, each supported by clinical evidence and by the rapidly evolving treatment landscape for TKI-refractory NSCLC. Lantern is seeking FDA feedback and concurrence on these proposed amendments as part of the mid-May Type C meeting.
Focus Future Trial Enrollment to EGFR Exon 21 L858R Patients. Exploratory analysis from HARMONIC™ demonstrates that this mutation-defined subgroup derives a meaningfully greater and more consistent benefit from the LP-300 triplet regimen compared with other EGFR-mutant patients enrolled in the trial, including those with Exon 19 deletions. A multivariable Cox regression analysis confirms that L858R mutation status is an independent predictor of progression-free survival, even after adjusting for potential confounders. This supports a biomarker-driven enrollment strategy consistent with contemporary precision oncology trial design.
Convert to a Phase 2 Single-Arm Simon Two-Stage Study Design. The rapid global adoption of more recently approved combination regimens for TKI-refractory EGFR mutant NSCLC has made continued randomization to the control arm — carboplatin and pemetrexed alone — increasingly untenable both scientifically and operationally.
Increase LP-300 Treatment Cycles from 6 to 8. Exploratory data from HARMONIC™ indicate that L858R patients completing 6 cycles of LP-300 regimen demonstrated an mPFS of 8.9 months — higher than the overall L858R cohort median — with a comparable safety profile to those completing fewer cycles. This dose-duration relationship is consistent with LP-300’s kinase inhibitory mechanism of action. Historical safety data from prior LP-300 clinical trials also confirms that up to eight doses administered at the current dose level using the current dosing interval did not alter the established safety profile of the drug.
A Substantially Cleaner Tolerability Profile
LP-300 adds no new or clinically significant toxicity to the carboplatin and pemetrexed chemotherapy backbone. When the HARMONIC™ safety data to date is reviewed alongside published safety data from recently approved combination regimens in the TKI-refractory NSCLC setting, the contrast in treatment burden is clinically striking. The following comparison is based on available published data and reflects a review of LP-300’s safety profile versus a reference regimen from a larger randomized trial in a comparable, though not identical, patient population (Passaro et al., Annals of Oncology, 2024).
Lantern Pharma emphasizes that cross-trial safety comparisons should be interpreted with caution given potential differences in patient populations, study design, and data collection.
The select highlights in the table below summarize pertinent safety observations (>20%) regarding Treatment-Emergent Adverse Events (TEAE) that were determined to be Treatment Related Adverse Events (TRAE). A Treatment-Emergent Adverse Event in clinical trials is an unfavorable medical occurrence that starts or worsens in intensity or frequency after the first dose of study treatment.
Adverse Event Parameter
LP-300 + Carbo/Pem (N=31)
Reference Regimen* (N=130)
Treatment-Related SAE
1 (3%)
30 (23%)
Rash (TRAE)
2 (7%)
56 (43%)
Paronychia (TRAE)
0 (0%)
47 (36%)
*Reference regimen data: Passaro A, et al. Amivantamab plus chemotherapy with and without lazertinib in EGFR-mutant advanced NSCLC after disease progression on osimertinib: primary results from the phase III MARIPOSA-2 study. Ann Oncol. 2024;35(1):77–90. Direct comparisons between trials should be made with caution given differences in patient populations, study design, and enrollment criteria.
For patients who have already navigated prior lines of therapy, treatment burden and quality of life are not secondary considerations. The ability to deliver comparable clinical activity with a substantially cleaner tolerability profile represents a meaningful point of differentiation in a therapeutic setting that has historically been associated with significant treatment-related morbidity.
Addressing a Large and Growing Unmet Need in EGFR-Mutant Lung Cancer
EGFR-mutant non-small cell lung cancer is one of the largest molecularly defined oncology markets globally, with approximately 350,000 new cases diagnosed annually worldwide. The EGFR Exon 21 L858R mutation — the subgroup demonstrating the most consistent observed benefit to date from LP-300 in HARMONIC™ — accounts for approximately 40% of all EGFR-mutant NSCLC cases, representing an estimated 90,000 to 100,000 patients per year.
The commercial significance of this population is growing. As osimertinib has become the established frontline standard of care globally, a substantial and increasing number of patients are completing first-line treatment and entering the post-TKI setting — the precise setting where HARMONIC™ data point to LP-300’s greatest potential clinical activity. The L858R subgroup carries a particularly poor prognosis following osimertinib failure, and existing approved options in this setting are associated with significant tolerability challenges that may limit real-world use and patient quality of life.
The market opportunity is further amplified by geography. The L858R mutation is disproportionately represented among never-smokers, who account for 35 to 40% of all NSCLC cases in Asia compared with approximately 15 to 17% in the United States and Europe. Lantern is evaluating patients across clinical sites in the United States, Japan, and Taiwan, and is exploring regional and global collaboration opportunities to maximize LP-300’s commercial potential across these geographies.
The treatment of never-smokers with NSCLC represents an estimated $4 billion or more in annual market opportunity. Lantern believes LP-300’s emerging profile — combining a consistent mutation-selective efficacy signal with a substantially differentiated tolerability profile — positions it as a potentially meaningful treatment option for a patient population with significant unmet need.
Biological Refinement: The Never-Smoker and L858R Intersection
HARMONIC™ was originally designed to address a critically underserved population: never-smokers with TKI-refractory NSCLC, for whom no therapy has been specifically approved. The EGFR L858R mutation is substantially enriched in never-smoker populations — particularly in Asian patient cohorts where never-smokers represent 35 to 40% of all NSCLC cases. The proposed enrollment further refines this mission; it resolves the never-smoker thesis molecularly into a more precise patient definition, concentrated on the subgroup where LP-300 appears most consistently active and beneficial.
Management Commentary
“The patients participating in HARMONIC™ are facing a serious illness with real courage, and often with few remaining options. Their willingness to take part in this research is what makes progress possible, and it is the reason we approach this work with both urgency and humility.
The emerging data in patients with the EGFR L858R mutation — an 8.3-month progression-free survival signal in a post-TKI setting, without additional toxicity burden — is an encouraging early finding. We understand that this is preliminary data in a small patient cohort, but the signal is consistent with the biology, and it warrants a focused, disciplined development path.
Our Type C meeting with the FDA is a collaborative step in that direction. We want their input, we respect their process, and our goal is straightforward — to determine whether LP-300 can make a meaningful difference for patients who are running out of options, and to get there as efficiently as we can.”
— Panna Sharma, President and Chief Executive Officer, Lantern Pharma Inc.
Collaboration and Partnership Opportunities
Lantern Pharma is actively exploring collaboration and partnering opportunities — both globally and regionally — to maximize LP-300’s commercial potential across multiple geographies. The Company’s RADR® AI platform, which integrates multi-omic biomarker data with clinical outcomes, has been instrumental in confirming and better understanding the L858R signal and continues to inform patient selection strategy and combination approaches for LP-300.
About LP-300 and the HARMONIC™ Trial
LP-300 is an investigational agent being evaluated in Lantern Pharma’s Phase 2 HARMONIC™ trial in combination with carboplatin and pemetrexed in patients with advanced NSCLC who have progressed following TKI therapy. The trial includes patients across clinical sites in the United States, Japan, and Taiwan. LP-300 has not received FDA marketing approval. All clinical data referenced in this press release are preliminary and have not been source verified in their entirety; Data Cutoff: April 13, 2026.
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 HARMONIC™ clinical trial; LP-300’s potential clinical activity and tolerability profile; the proposed FDA Type C meeting and protocol amendments; our clinical development plans; expectations and estimates regarding clinical trial timing and patient enrollment; estimates regarding patient populations, potential markets and potential market sizes; 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 emerging or preliminary observations in clinical studies do not ensure that later observations, studies and development will be consistent or successful, (iii) the risk that the FDA may not concur with the proposed HARMONIC™ protocol amendments, (iv) the risk that any clinical benefit observed to date relating to LP-300 may not be reproduced in the completed HARMONIC™ trial or in larger or confirmatory studies, (v) the risk that clinical data referenced in this press release are exploratory and preliminary, based on small patient cohorts, and may not be representative of outcomes in broader populations, (vi) the risk that cross-trial comparisons are provided for context only and should not be interpreted as direct evidence of comparative safety or efficacy, (vii) the risk that our research and the research of our collaborators may not be successful, (viii) the risk that we may not be successful in licensing our product candidates or in completing potential partnerships and collaborations, (ix) 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, and (x) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2025, filed with the Securities and Exchange Commission on March 30, 2026.
You may access our Annual Report on Form 10-K for the year ended December 31, 2025 under the investor SEC filings tab of our website at www.lanternpharma.com or on the SEC’s website at www.sec.gov. Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260420812445/en/
INVESTOR RELATIONS CONTACT
Lantern Pharma Inc.
ir@lanternpharma.com
+1-972-277-1136
Original: Emerging Data for Lantern Pharma’s Investigational Drug LP-300 Demonstrates 8.3-Month Median Progression-Free Survival in Patients with EGFR L858R Lung Cancer After Targeted Therapy Failure — With No Added Toxicity
US Market News
3月前
Lantern Pharma Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business UpdatesMarch 30, 2026 4:05 PM
Business Wire
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, and Taiwan. Completion of targeted enrollment in Japan across five clinical sites including the National Cancer Center Tokyo. Preliminary data presented at the 66th Annual Meeting of the Japan Lung Cancer Society. Type C meeting package submitted to FDA in March 2026, with meeting scheduled for mid-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 in India to industrialize the RADR® platform and accelerate global biopharma development opportunities. Presentation at 7th Glioblastoma Drug Development Summit in Boston.
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 of December 31, 2025.
Conference call and webcast scheduled for Monday, March 30, 2026 at 4:30 p.m. ET.
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.
“2025 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 balance sheet.”
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 $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.
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 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 (TKI) therapy.
Key Milestones:
Japan Enrollment Completed: In July 2025, Lantern completed targeted enrollment in Japan 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 and U.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 across U.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 for mid-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 $4 billion annually. Currently, there are no therapies specifically approved for never-smoker NSCLC patients.
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 $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.
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 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).
RADR® AI Platform: Global Expansion and Commercial Momentum
AI Center of Excellence in India
In 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.
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 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.
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 $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.
“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 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.”
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.
R&D Investment by Program (Full Year 2025):
For the year ended December 31, 2025, our approximate research and development costs by project were: LP-300 ($4.6M), LP-184 ($4.3M), LP-284 ($1.2M), RADR® Platform ($1.0M), and other programs ($0.4M), totaling approximately $11.5 million.
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. Panna Sharma continues to serve as President and Chief Executive Officer with the full confidence of the Board of Directors, and together with the management team, continues to actively lead the company’s day-to-day operations, clinical development strategy, partnership discussions, and capital planning efforts. Lantern Pharma encourages its investors and stakeholders to rely on the company’s SEC filings, press releases, and official communications through its established disclosure channels for genuine information about the company and its leadership.
Financial Results for Fourth Quarter and Full Year 2025
Balance Sheet:
Cash, cash equivalents, and marketable securities were approximately $10.1 million as of December 31, 2025 (consisting of approximately $4.4 million in cash and cash equivalents and approximately $5.7 million in marketable securities), compared to approximately $24.0 million as of December 31, 2024. The company believes that its existing cash, cash equivalents, and marketable securities will enable it to fund anticipated operating expenses and capital expenditure requirements until at least approximately late July 2026 to mid September 2026. The company will need to obtain substantial additional funding in the near future and it is actively evaluating and pursuing potential funding alternatives.
Full Year 2025 Results:
Research and Development Expenses: R&D expenses were approximately $11.5 million for the year ended December 31, 2025, compared to approximately $16.1 million for the year ended December 31, 2024, a decrease of approximately $4.6 million or 29%. The decrease was primarily attributable to decreases in research studies and materials of approximately $4,034,000 relating to clinical trials, decreases in payroll and compensation expenses of approximately $610,000, and decreases in consulting expenses of approximately $81,000, partially offset by increases in licensing expenses of approximately $113,000.
General and Administrative Expenses: G&A expenses were approximately $6.5 million for the year ended December 31, 2025, compared to approximately $6.1 million for the year ended December 31, 2024, an increase of approximately $373,000 or 6%. The increase was primarily attributable to increases in business development and investor relations expenditures of approximately $436,000, increases in patent costs of approximately $55,000, and increases in corporate insurance expenses of approximately $51,000, offset in part by decreases in payroll and compensation expenses of approximately $115,000.
Net Loss: Net loss was approximately $17.1 million (or $1.57 per share) for the year ended December 31, 2025, compared to a net loss of approximately $20.8 million (or $1.93 per share) for the year ended December 31, 2024, representing a year-over-year reduction of net loss of approximately $3.7 million or 18%.
Fourth Quarter 2025 Results:
Total Operating Expenses: Total operating expenses were approximately $4.2 million for the quarter ended December 31, 2025, compared to approximately $5.9 million for the quarter ended December 31, 2024. Q4 2025 R&D expenses were approximately $2.7 million compared to approximately $4.3 million in Q4 2024. Q4 2025 G&A expenses were approximately $1.5 million compared to approximately $1.6 million in Q4 2024.
Net Loss: Net loss was approximately $4.1 million for the quarter ended December 31, 2025, compared to a net loss of approximately $5.9 million for the quarter ended December 31, 2024.
Capitalization:
As of December 31, 2025, the Company had 11,254,697 shares of common stock outstanding, and options to purchase 1,296,126 shares of common stock at a weighted average exercise price of $5.58 per share were outstanding. As of December 31, 2025, there were no warrants outstanding.
In July 2025, the Company entered into an ATM Sales Agreement with ThinkEquity LLC, pursuant to which the Company may offer and sell up to $15,530,000 of its common stock in “at-the-market” offerings. During the year ended December 31, 2025, the Company sold 356,922 shares under the ATM for gross proceeds of $1,624,547.
Lantern Pharma Inc. and Subsidiaries
Consolidated Balance Sheets
December 31, 2025
December 31, 2024
CURRENT ASSETS
Cash and cash equivalents
$4,422,838
$7,511,079
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
$11,035,811
$25,571,792
CURRENT LIABILITIES
Accounts payable and accrued expenses
$4,423,048
$4,140,361
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
$11,035,811
$25,571,792
Lantern Pharma Inc. and Subsidiaries
Consolidated Statements of Operations
Year Ended Dec 31, 2025
Year Ended Dec 31, 2024
Operating expenses:
General and administrative
$6,464,371
$6,090,747
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
$(17,119,438)
$(20,781,213)
Net loss per share, basic and diluted
$(1.57)
$(1.93)
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
Lantern Pharma will host a conference call and webcast to discuss fourth quarter and full year 2025 financial results and business updates on Monday, March 30, 2026 at 4:30 p.m. Eastern Time.
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 Lantern Pharma
Lantern Pharma (NASDAQ: LTRN) is an AI-driven company transforming the cost, pace, and timeline of oncology drug discovery and development. Our proprietary AI and machine learning (ML) platform, RADR®, leverages over 200 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve billion-dollar, real-world problems in oncology drug development and generate oncology medicines at dramatically reduced costs and accelerated timelines. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, we have accelerated the development of our growing pipeline of drug candidates that span multiple cancer indications, including both solid tumors and blood cancers and an antibody-drug conjugate (ADC) program. 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.
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 $15 billion USD.
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 December 31, 2025, filed with the Securities and Exchange Commission on March 30, 2026.
You may access our Annual Report on Form 10-K for the year ended December 31, 2025 under the investor SEC filings tab of our website at www.lanternpharma.com or on the SEC’s website at www.sec.gov. Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations.
Lantern Pharma Disclosure Channels to Disseminate Information
Lantern Pharma’s investors and others should note that we announce material information to the public about our company through a variety of means, including our website, press releases, SEC filings, digital newsletters, and social media, in order to achieve broad, non-exclusionary distribution of information to the public. We encourage our investors and others to review the information we make public in the locations above as such information could be deemed to be material information. Please note that this list may be updated from time to time.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260330282182/en/
Investor Contact
Investor Relations
ir@lanternpharma.com
+1-972-277-1136
Original: Lantern Pharma Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates
US Market News
3月前
Lantern Pharma and Starlight Therapeutics Announce FDA Clearance of IND for a Planned Phase 1 Pediatric CNS Cancer Trial of STAR-001March 27, 2026 7:29 AM
Business Wire
The Planned Multicenter Phase 1 Trial Will Evaluate STAR-001 as Monotherapy and in Combination with Spironolactone in Children with Relapsed or Refractory CNS Malignancies, Including ATRT, DIPG, GBM, Medulloblastoma, and Ependymoma
Lantern Pharma Inc. (NASDAQ: LTRN) and its CNS-oncology focused wholly owned subsidiary Starlight Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for STAR-001 in a planned Phase 1 pediatric clinical trial (IND No. 179145).
STAR-001 is a precision oncology compound whose CNS and pediatric CNS indications were initially identified using Lantern's proprietary RADR® AI platform. The planned trial will evaluate STAR-001 as a single agent and in combination with spironolactone in pediatric patients with relapsed or refractory central nervous system (CNS) malignancies.
The trial is planned to be conducted in collaboration with POETIC — the Pediatric Oncology Experimental Therapeutics Investigators' Consortium — a multicenter network of 14 leading academic children's cancer centers across the United States, Canada, and Israel. The study protocol, as reviewed and cleared by the FDA, is titled:
"A PHASE 1, MULTICENTER, OPEN-LABEL, DOSE ESCALATION STUDY OF STAR-001 (LP-184) AS A SINGLE AGENT AND IN COMBINATION WITH SPIRONOLACTONE IN PEDIATRIC PATIENTS WITH RELAPSED OR REFRACTORY CENTRAL NERVOUS SYSTEM MALIGNANCIES."
ADDRESSING A CRITICAL UNMET NEED IN PEDIATRIC NEURO-ONCOLOGY
Pediatric CNS tumors represent one of the most devastating and treatment-resistant categories of childhood cancer. In the United States, an estimated 4,975 new cases of primary brain tumors will be diagnosed in children and adolescents in 2026 alone — making brain tumors the leading cause of cancer-related death among children and adolescents ages 0 to 19. The burden extends far beyond U.S. borders: globally, approximately 47,600 new pediatric CNS tumor cases are diagnosed each year, resulting in an estimated 23,500 deaths annually. Across Europe, the disease is similarly pervasive, with wide disparities in survival outcomes for children facing high-grade or relapsed cancers.
Despite significant advances in molecular profiling and surgical technique over the past two decades, survival outcomes for children with relapsed or refractory high-grade CNS tumors have improved only marginally. For certain diagnoses, the prognosis remains catastrophic. Diffuse Intrinsic Pontine Glioma (DIPG), for instance, carries a median survival of less than 12 months from diagnosis with no approved curative option. For children with relapsed ATRT, GBM, medulloblastoma, and ependymoma, current therapeutic options are equally limited and often associated with severe long-term toxicity.
The trial design provides for STAR-001 (LP-184) to be evaluated across a range of these aggressive pediatric CNS malignancies, including:
Atypical Teratoid/Rhabdoid Tumor (ATRT) — for which Lantern Pharma holds FDA Rare Pediatric Disease Designation
Diffuse Intrinsic Pontine Glioma (DIPG) — a brainstem tumor with virtually no long-term survivors under current standard of care
Glioblastoma (GBM)
Medulloblastoma
Ependymoma
"This IND clearance is a defining milestone for Starlight Therapeutics and a meaningful step forward for pediatric neuro-oncology. For children with relapsed or refractory CNS tumors, the options are desperately limited — and the science behind this planned trial was built to change that. CNS and pediatric CNS cancers were initially identified as priority indications by our team in support from our RADR® AI platform, and that same analysis led us to ERCC3, a DNA repair enzyme that high-grade CNS tumors rely on to survive. Our modeling, analysis and subsequent in-vivo and animal studies showed that spironolactone could dismantle that pathway by degrading ERCC3 before STAR-001 even enters the cancer cell. In ATRT models, the combination extended median survival by 181% compared to the control. We believe this represents a genuinely new way to attack these brain cancers, and we are proud to be advancing it through a network of some of the world's most respected pediatric oncology centers."
— Panna Sharma, CEO & President, Lantern Pharma Inc.; Founder & Chairman, Starlight Therapeutics
NOVEL BIOLOGY: TARGETING ERCC3 TO AMPLIFY DNA DAMAGE — A FIRST-IN-CLASS COMBINATION STRATEGY
A scientifically distinctive and potentially first-in-class feature of the planned trial is a dedicated combination cohort evaluating STAR-001 alongside spironolactone — exploiting a biological vulnerability in CNS tumor cells that Lantern's RADR® AI platform, helped in part to identify as a novel approach to creating synthetic lethality in these brain tumors.
STAR-001 operates through a precision bioactivation mechanism: selectively converted into a potent DNA-crosslinking agent within tumor cells that overexpress PTGR1 (Prostaglandin Reductase 1), it induces DNA double-strand breaks that are lethal to the cancer cell — if left unrepaired. By degrading ERCC3, spironolactone removes that option.
Lantern's RADR® AI platform identified ERCC3 (Excision Repair Cross-Complementation Group 3) — a key helicase in the nucleotide excision repair (NER) pathway — as a central repair mechanism that could be exploited in high-grade pediatric CNS malignancies including ATRT, medulloblastoma, and diffuse midline glioma, compared to low-grade gliomas. Spironolactone — a brain-penetrant, orally administered agent with a long safety record in pediatric patients — degrades ERCC3 through targeted proteasomal degradation, reducing ERCC3 protein levels by at least 50% across tumor models and confirming direct target engagement. With this repair pathway dismantled, STAR-001-induced DNA damage accumulates unrepaired, driving dramatically enhanced tumor cell death based on preclinical observations. In ATRT orthotopic xenograft models, the combination extended median survival from 27 to 76 days — a 181% improvement over control (p = 0.0018) — with comparable results across medulloblastoma and DMG models showing up to a 3- to 5-fold increase in apoptotic cells versus monotherapy (p < 0.0001).
This two-pronged strategy — AI-guided identification of a DNA repair vulnerability, precision bioactivation of a DNA-damaging agent, and pharmacological elimination of the tumor cell's repair escape route — represents a mechanistically coherent and potentially transformative approach to pediatric CNS cancers where conventional chemotherapy has reached its limits.
"High-grade pediatric brain tumors represent a significant unmet medical need, with few effective options for children whose disease has relapsed or become refractory to standard therapy. STAR-001 is a novel, precision brain-penetrant alkylator, bioactivated by PTGR1, that has demonstrated meaningful activity across multiple malignant pediatric brain tumor types in preclinical models. In collaboration with the POETIC consortium, we have developed a Phase 1 pediatric protocol — reviewed and cleared by the FDA — to assess the safety, tolerability, and preliminary activity of STAR-001, both as a single agent and in combination with spironolactone, in children with recurrent malignant brain tumors. We look forward to initiating this planned trial and to the possibility of delivering a new therapeutic option to children who need it most."
— Marc Chamberlain, M.D., Chief Medical Officer, Starlight Therapeutics
MULTICENTER PEDIATRIC CLINICAL TRIAL DESIGN
The planned trial will be conducted across approximately 15 leading academic pediatric oncology centers in collaboration with POETIC (Pediatric Oncology Experimental Therapeutics Investigators' Consortium), a multicenter network of 14 institutions — including MD Anderson Cancer Center, Memorial Sloan Kettering Cancer Center, and Lucile Packard Children's Hospital at Stanford — spanning the United States, Canada, and Israel. The planned trial is subject to obtaining additional funding and it is designed to enroll approximately 18 to 42 pediatric patients aged 1 to 17 years. POETIC's established clinical infrastructure provides Starlight with the reach to enroll a geographically and demographically diverse patient population across North America and internationally.
ABOUT STAR-001 (LP-184)
STAR-001 is Starlight Therapeutics' CNS oncology compound, co-developed with Lantern Pharma as LP-184. CNS and pediatric CNS cancers were initially identified as priority indications for STAR-001 through Lantern's proprietary RADR® AI platform, which analyzed genomic and molecular data across tumor types to pinpoint the PTGR1 overexpression signature that makes these malignancies particularly susceptible to STAR-001's mechanism of action. STAR-001 is a precision acylfulvene-based agent engineered to exploit elevated PTGR1 (Prostaglandin Reductase 1) expression in tumor cells. Laboratory observations have demonstrated that PTGR1-mediated bioactivation selectively converts STAR-001 into a highly reactive DNA-crosslinking species within cancer cells, while normal tissues with lower PTGR1 activity are largely spared. LP-184/STAR-001 has received multiple FDA orphan and rare pediatric disease designations and has demonstrated encouraging activity in early-stage clinical and preclinical studies. In pediatric CNS cancers — where PTGR1 overexpression has been identified across ATRT, GBM, DIPG, medulloblastoma, and ependymoma — we believe STAR-001 represents a scientifically grounded precision approach to a historically intractable disease.
ABOUT STARLIGHT THERAPEUTICS
Starlight Therapeutics is a CNS-focused clinical-stage biopharmaceutical company and wholly owned subsidiary of Lantern Pharma Inc. (NASDAQ: LTRN). Starlight is advancing STAR-001 (LP-184) as its lead program through planned pediatric and adult CNS cancer trials. For more information, visit www.starlightthera.com.
ABOUT POETIC
The Pediatric Oncology Experimental Therapeutics Investigators' Consortium (POETIC) is a collaborative network of 14 leading academic medical centers dedicated to accelerating the early clinical development of promising therapies for children, adolescents, and young adults with cancer and related disorders. Founded in 2003, POETIC has enrolled more than 429 patients across 16 completed clinical trials and currently has three new trials ongoing. POETIC's Research Development and Management Center is based at Stanford University. For more information, visit www.poeticphase1.org.
ABOUT LANTERN PHARMA
Lantern Pharma (NASDAQ: LTRN) is an AI-driven biotechnology company focused on accelerating and optimizing the discovery, development, and commercialization of cancer therapies. Its proprietary RADR® platform leverages artificial intelligence and machine learning to uncover novel therapeutic opportunities, accelerate drug development timelines, and improve patient outcomes. For more information, visit www.lanternpharma.com.
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 in identifying drug candidates and patient populations that are likely to respond to a drug candidate; our strategic plans to advance the development of our drug candidates and antibody drug conjugate (ADC) development program; estimates regarding the development timing for our drug candidates and ADC development program; potential partnerships and collaborations; 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, and (vii) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 27, 2025.
You may access our Annual Report on Form 10-K for the year ended December 31, 2024 under the investor SEC filings tab of our website at http://www.lanternpharma.com/ or on the SEC's website at http://www.sec.gov/. Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260327252026/en/
INVESTOR CONTACT
Investor Relations — Lantern Pharma
US Market News
3月前
Lantern Pharma to Report Fourth Quarter and Fiscal Year 2025 Operating & Financial Results on March 30th, 2026 at 4:30 p.m. ETMarch 23, 2026 4:30 PM
Business Wire
Webcast to be held Monday, March 30th, 4:30 p.m. ET, register for the webcast here, or at the link provided below.
Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (“AI”) company developing targeted and transformative cancer therapies using its proprietary RADR® AI and machine learning (“ML”) platform with multiple clinical stage drug programs, today announced that it will host its fourth quarter and fiscal year 2025 operating and financial results webcast on Monday, March 30, 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time.
Management intends to discuss the operating and financial results for the fourth quarter and fiscal year ended December 31, 2025 and provide guidance on upcoming milestones, clinical trials and developments of the AI platform, RADR®. Panna Sharma, President and Chief Executive Officer of Lantern Pharma, will lead the call and will be joined by other members of the management team.
To register for the webinar, please sign up at the Zoom webcast link provided in the link: Lantern Pharma Q4 2025 earnings Zoom webcast registration link. A replay of the earnings call webcast will be available after the call on the investor relations section of the Company's website: ir.lanternpharma.com.
About Lantern Pharma
Lantern Pharma (NASDAQ: LTRN) is an AI-driven biotechnology company focused on accelerating and optimizing the discovery, development, and commercialization of cancer therapies. Its proprietary RADR® platform leverages artificial intelligence and machine learning to uncover novel therapeutic opportunities, accelerate drug development timelines, and improve patient outcomes.
For more information, visit:
Website: www.lanternpharma.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 in identifying drug candidates and patient populations that are likely to respond to a drug candidate; our strategic plans to advance the development of our drug candidates and antibody drug conjugate (ADC) development program; estimates regarding the development timing for our drug candidates and ADC development program; potential partnerships and collaborations; 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, and (vii) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 27, 2025.
You may access our Annual Report on Form 10-K for the year ended December 31, 2024 under the investor SEC filings tab of our website at http://www.lanternpharma.com/ or on the SEC’s website at http://www.sec.gov/. Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations.
View source version on businesswire.com: https://www.businesswire.com/news/home/20260323977206/en/
Investor Contact
Investor Relations
ir@lanternpharma.com
+1-972-277-1136
Original: Lantern Pharma to Report Fourth Quarter and Fiscal Year 2025 Operating & Financial Results on March 30th, 2026 at 4:30 p.m. ET