Full Press Release Details
Lantern Pharma Reports First Quarter 2025 Financial
Results and Business Updates
| Completion of LP-184 Phase 1a clinical trial enrollment with 62-65 patients across a range of solid tumors expected by end of June 2025 . | ||
| Additional patient data readout from the HARMONIC Trial evaluating LP-300 in never-smokers with non-small cell lung cancer (NSCLC) anticipated in Q3 2025 , including initial readout for patients from the Asian expansion cohort. | ||
| Strengthened AI intellectual property portfolio with PCT publication of proprietary blood-brain barrier penetration prediction patent application; favorable PCT search report indicated no significant prior art. | ||
| Expanded RADR platform with innovative AI-powered module to improve the precision, cost and timeline of antibody-drug conjugate (ADC) development, integrating a multiomic approach using proprietary algorithms to design and optimize target, payload, and tumor selectivity. | ||
| Planning commercial availability and launch of select RADR AI modules for the scientific and research community to foster collaborative, open-source innovation in cancer drug development. | ||
| Obtained further independent preclinical confirmation of LP-184 hypersensitivity in rare pediatric brain tumors , such as ATRT, by our collaborators at Johns Hopkins in support of planned pediatric trial in CNS tumors. | ||
| Maintained disciplined capital management , with approximately $19.7 million in cash, cash equivalents, and marketable securities as of March 31, 2025, providing expected operating runway through at least May 15, 2026. | ||
| The conference call and webcast are scheduled for Thursday, May 15, 2025 at 9:00 a.m. ET. |
DALLAS-(BUSINESS WIRE)- May
15, 2025 - 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 first quarter 2025 ended March 31, 2025, and provided
an update on its portfolio of AI-driven drug candidates, the RADR platform for precision oncology drug development enhancements,
and other operational progress.
quarter represents a pivotal inflection point in our clinical and technological development. As we approach full enrollment in our LP-184
Phase 1a trial and prepare for an additional data readout for our LP-300 Harmonic Trial, including initial data from our Asian expansion
cohort, we are positioning ourselves for productive discussions with potential biopharma partners. Simultaneously, our RADR AI
platform has reached a crucial development milestone with a broad and validated range of oncology drug development modules powered by
hundreds of billions of datapoints. These advancements further validate our AI-driven approach to cancer drug development, which is focused
on addressing real-world, unmet patient needs while establishing a clear pathway toward commercialization focused on delivering value
to patients and shareholders." -Panna Sharma, CEO & President of Lantern Pharma
Drug Development Pipeline Highlights:
Phase 2 HARMONIC trial for LP-300 continued to advance during Q1 2025 with patients enrolled in Japan and Taiwan and ongoing enrollment
in the US. Never-smokers with NSCLC in East Asia represent approximately 33% to 40% of new NSCLC cases as compared to the U.S., where
never smokers account for approximately 15% of new NSCLC cases. LP-300 is being evaluated in combination with standard-of-care chemotherapy
(carboplatin + pemetrexed) in never-smokers with NSCLC adenocarcinoma who have progressed after TKI therapy. The trial is designed
to enroll approximately 90 patients across the U.S. and East Asia.
2 Clinical Results: Preliminary data from the Phase 2 U.S. safety, lead-in cohort showed an 86% clinical benefit rate and a 43%
objective response rate. Additional patient data from the expansion cohort continues to support, at the current time, a similar patient
response and clinical benefit rate trend. Lantern plans on sharing additional results, which will include updated data from patients
enrolled in the lead-in cohort and new data from patients in the Asian expansion cohort, during Q3 of 2025.
continued advancements through a Phase 1a trial in multiple solid tumors, which is targeted to finish enrollment during June of 2025.
LP-184 has received Fast Track Designations from the FDA for GBM (Glioblastoma Multiforme) and TNBC (Triple Negative Breast
Cancer). Additionally, LP-184 has four Rare Pediatric Disease Designations for hepatoblastoma, rhabdomyosarcoma, and malignant
rhabdoid tumors, and ATRT (atypical teratoid, rhabdoid tumors).
1a Results: Safety, Tolerability, Pharmacokinetics including MTD Determination - The trial has now enrolled through cohort 12,
and early indications of clinical activity have been observed at higher dose levels, consistent with preliminary PK data. During Q1 2025,
the Safety Review Committee (SRC) along with the Company, made the decision to backfill dose levels 10 and 11 to ensure clarity on the
maximum tolerated dose (MTD) while ensuring the safety of study participants, and assessing the clinical activity of the dose to guide
future LP-184 clinical trials. Enrollment at dose level 9 and higher has been focused on inclusion of advanced solid tumor patients that
have identified DNA damage repair mutations. A broader clinical data update is slated for Q3 of 2025, when complete safety, pharmacokinetic
and dose response data along with biomarker correlations is expected to be available.
Future Planned Phase 1b/2 Trials: Lantern
has recently cleared two clinical trial protocols with the FDA that can provide a path towards a regulatory approval.
The first, announced on May 5th, is for
a Phase 1b/2 study in TNBC evaluating LP-184 in both a combination regimen with the PARP inhibitor, Olaparib and as monotherapy in
the same indication. The FDA has raised no objections to the protocol, and Lantern plans to initiate this trial in both the US and
at leading academic cancer centers in Nigeria and India, subject to clinical priorities and funding. The
average survival for newly diagnosed, metastatic TNBC is estimated at 8 to 13 months and presents an annual market opportunity
in excess of $4 billion USD.
The second, announced on May 12th, is for
a Phase1b/2 study in a biomarker defined subset of drug-resistant non-small cell lung cancer that has mutations in the STK11 and/or
KEAP1 genes. This unique trial is aimed at addressing a critical unmet clinical
need in lung cancer care: the median overall survival in newly
diagnosed, advanced NSCLC patients with KEAP1 and/or STK11 mutations
treated with chemo-immunotherapy averages 15 months, substantially lower than outcomes in
mutation negative populations. For patients that fail earlier lines of therapies the overall survival tends to skew even lower
at approximately 6.3 months. This represents a market opportunity exceeding $2 billion
annually, given the prevalence and poor prognosis for patients with these mutations.
Additionally, an investigator-led, exploratory
clinical trial of LP-184 for recurrent bladder cancer is planned to begin in Denmark during Q3 of 2025. This clinical trial is designed
to test LP-184 as a monotherapy specifically in advanced, recurrent bladder cancer patients with DNA damage repair mutations with the
potential to create a path towards data to support usage in the 3rd line setting.
Lantern's proprietary RADR
platform has grown during Q1 2025 to approximately 200 billion oncology-focused data points across multiple sources (proprietary,
collaborative and public) of oncology, molecular, clinical, biochemical, and preclinical datasets.
RADR continues to play
an important role in advancing:
| drug candidate optimization, | ||
| development and validation of clinically relevant drug-candidate combinations, | ||
| identification of mechanism(s) of action, | ||
| identification of optimal indications for drug-candidate advancement, | ||
| creation of biomarker signatures to support patient selection, | ||
| optimization and characterization of molecular features, and | ||
| prediction of the blood brain barrier (BBB) potential of a molecule. |
AI and platform-driven insights contributed
to LP-184's clinical biomarker strategy, including a qPCR assay for PTGR1 to guide patient stratification, and aided in the identification
of multiple indications leading to orphan and rare pediatric disease designations. Additionally, RADR also underpinned
combination strategies, such as LP-184 with PARP inhibitors and LP-284 with rituximab. Future plans and proposed developments include
additional collaborations with leading oncology development groups and biopharma companies in both adult and pediatric cancers. Lantern
expects to publicly release multiple modules (validated A.I. frameworks) that can be accessed by Lantern collaborators and the research
community for specific needs in oncology drug development-such as prediction of certain molecular features including the BBB
penetrability of a molecule, identification of potential cancer indications that are more likely to show a higher sensitivity to a molecule
or drug-candidate, and aiding the development of optimized paths to demonstrate potential therapeutic utility of a molecule in a rare
Starlight Therapeutics:
Lantern's wholly owned subsidiary
focused on CNS and brain cancers, Starlight Therapeutics, made key advances towards the design, development and approval of adult and
pediatric trials, including potential investigator-initiated clinical trials for STAR-001. LP-184, referred to as STAR-001 for
CNS indications, was highlighted at the Society for Neuro-Oncology (SNO) 2024 conference, with a Phase 1b/2 trial in recurrent GBM anticipated
to begin in late 2025 subject to successful additional funding and clearance of the protocol. Additionally, further preclinical studies
led by Lantern's collaborators at Johns Hopkins provided independent confirmation of LP-184 hypersensitivity in rare pediatric
brain tumors, in support of a clinical trial being planned with a pediatric consortium in CNS tumors.
Additional Operational Highlights:
Lantern also advanced a proprietary BBB
permeability prediction algorithm with a favorable PCT patent application report, advancing our AI leadership with Lantern's algorithms
now holding five of the top ten positions on Therapeutic Data Commons (TDC) Leaderboard. The company is developing a publicly available
tool to predict the BBB permeability of any molecule that can be readily accessed by the research and drug development community,
which is planned for initial launch during the second half of 2025.
First Quarter 2025 Financial Highlights:
| Balance Sheet : Cash, cash equivalents, and marketable securities were approximately $ 19.7 million as of March 31, 202 5 , compared to approximately $ 24.0 million as of December 31, 202 4 . | ||
| R&D Expenses : Research and development expenses were approximately $ 3.3 million for the quarter ended March 31, 202 5 , compared to approximately $ 4.3 million for the quarter ended March 31, 202 4 . | ||
| G&A Expenses : General and administrative expenses were approximately $1. 5 million for the quarter ended March 31, 202 5 , essentially unchanged from approximately $1. 5 million for the quarter ended March 31, 202 4 . | ||
| Net Loss : Net loss was approximately $ 4.5 million (or $0. 42 per share) for the quarter ended March 31, 202 5 , compared to a net loss of approximately $ 5.4 million (or $0. 51 per share) for the quarter ended March 31, 202 4 . | ||
| Warrant Exercises : There were no warrants exercised during the three months ended March 31, 2025. The company has warrants to purchase 70,000 shares of common stock outstanding and exercisable as of March 31, 2025 at a weighted-average exercise price of $18.75 per share. These warrants will expire on June 10, 2025. |
About Lantern Pharma:
Lantern Pharma (NASDAQ: LTRN) is an
AI 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. 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 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 Phase 1 clinical trials. We have also established a wholly-owned subsidiary, Starlight Therapeutics,