On June 2, 2026 Lantern Pharma Inc. (NASDAQ: LTRN), an AI-driven precision oncology company, 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 (Free ASCO Whitepaper) 2026 in Chicago.

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"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.

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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 (Free ASCO Whitepaper) 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.

(Press release, Lantern Pharma, JUN 2, 2026, View Source [SID1234666376])