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Business Wire
15 hours ago
- Business
- Business Wire
Lantern Pharma Unveils Groundbreaking AI-Powered Module to Predict Activity and Efficacy of Combination Regimens in Clinical Cancer Treatment
DALLAS--(BUSINESS WIRE)--Lantern Pharma Inc. (NASDAQ: LTRN), a pioneering artificial intelligence (AI) company transforming oncology drug discovery and development, today announced the launch of an innovative AI-powered module within its proprietary RADR ® platform, designed to predict the activity and efficacy of combination regimens involving DNA-damaging agents (DDAs) and DNA damage response inhibitors (DDRis) in clinical cancer treatment. With the global market for combination cancer therapies projected to exceed $50 billion by 2030, growing at a CAGR of 8.5%, this module represents a significant advancement in precision oncology, enabling faster, more cost-effective development of tailored therapeutic regimens. Leveraging this AI-driven framework, Lantern Pharma has successfully architected and achieved FDA clearance for a Phase 1B/2 clinical trial in triple-negative breast cancer (TNBC), focusing on a novel DDA-DDRi combination regimen with promising preclinical efficacy. This AI-powered module is a transformative step in our mission to deliver personalized cancer treatments. By leveraging our RADR® platform to analyze complex multi-omics and clinical trial data, we identified optimal DDA-DDRi combinations that guided... Share In a peer-reviewed study published in Frontiers in Oncology, Clinical outcomes of DNA-damaging agents and DNA damage response inhibitors combinations in cancer: a data-driven review, Lantern Pharma researchers systematically analyzed 221 DDA-DDRi combination-arm clinical trials, involving 22 DDAs and 46 DDRis, to develop this module. The study categorized DDAs into eight subclasses (e.g., alkylating agents, interstrand cross-linkers) and DDRis into 14 subclasses (e.g., PARP, ATR, WEE1 inhibitors). From these, 89 trials with interpretable outcomes were scored for clinical effectiveness, safety, and biomarker-driven responses, providing a robust dataset to train the AI module. 1 Transforming Cancer Combination Therapy Development The new AI module represents a paradigm shift in precision oncology, leveraging machine learning to predict which drug combinations will be most effective for specific patient populations while minimizing toxicity risks. This data-driven approach has already demonstrated its value by successfully guiding the design of Lantern's FDA-cleared Phase 1B/2 clinical trial combining LP-184 with olaparib in triple-negative breast cancer (TNBC). "This AI-powered module is a transformative step in our mission to deliver personalized cancer treatments," said Panna Sharma, CEO & President of Lantern Pharma. "By leveraging our RADR ® platform to analyze complex multi-omics and clinical trial data, we identified optimal DDA-DDRi combinations that guided the development of our TNBC trial. We believe this approach could reduce combination therapy development timelines and costs by one-third compared to traditional methods." The module integrates genomic, transcriptomic, and clinical data to predict synergistic drug interactions, optimize therapeutic outcomes, and identify biomarker-defined patient subpopulations likely to respond to specific combinations. This data-driven approach directly informed the design of Lantern's FDA-cleared Phase 1B/2 trial in TNBC for LP-184 and olaparib, with potential to improve response rates and reduce toxicity. Key insights from the study powering the AI module include: Non-PARP Inhibitor Promise: Non-PARP DDRi combinations, particularly WEE1 inhibitors like adavosertib with platinum agents, showed an 80% positive outcome rate in interstrand cross-linker trials, with strong efficacy in TP53-mutated cancers, directly informing future trial design. Biomarker-Driven Success: Biomarkers such as TP53 mutations and HRD signatures were critical predictors of response, enabling patient stratification to maximize efficacy. Toxicity Mitigation: The use of novel formulations like liposomal doxorubicin in combination regimens reduced cardiotoxicity, providing a safer backbone for combination strategies. Emerging Trends: The analysis emphasizes the patterns in treatment effectiveness, safety, and emerging trends across various cancer types and discusses the potential of biomarkers to guide treatment selection and improve patient outcomes. The module's multi-agentic framework integrates specialized AI agents for data aggregation, drug classification, predictive modeling, biomarker identification, and optimization, creating a dynamic system that is planned to evolve along with new data. The system's continuous learning capability ensures adaptability, enabling Lantern to refine regimens and accelerate future trials across diverse cancer indications. The company is exploring licensing and commercialization opportunities to expand the application of this technology, further revolutionizing combination therapy development. 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 RADR ® platform leverages artificial intelligence and machine learning to uncover novel therapeutic opportunities, accelerate drug development, and improve patient outcomes. Please find more information at: 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; 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 or on the SEC's website at 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. 1 Fontenot R, Biyani N, Bhatia K, Ewesuedo R, Chamberlain M and Sharma P (2025) Clinical outcomes of DNA-damaging agents and DNA damage response inhibitors combinations in cancer: a data-driven review. Front. Oncol. 15:1577468. doi: 10.3389/fonc.2025.1577468
Yahoo
16-06-2025
- Business
- Yahoo
Lung Cancer Patient in Lantern Pharma's Harmonic Trial Shows Durable Complete Response in Target Cancer Lesions with Survival Continuing for Nearly Two Years
DALLAS, June 16, 2025--(BUSINESS WIRE)--Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company developing targeted cancer therapies using its proprietary RADR® AI platform, today announces remarkable clinical observations for a patient in Lantern's Phase 2 HARMONIC™ clinical trial. A 70-year-old never-smoker with advanced non-small cell lung cancer (NSCLC) has achieved a durable complete response in their target cancer lesions following treatment with LP-300 in combination with standard-of-care chemotherapy. Importantly, the patient continues to show sustained survival benefits after nearly two years. The patient, who had previously failed three lines of prior therapy including Keytruda (pembrolizumab) with chemotherapy, radiation therapy, and the EGFR inhibitor Tagrisso (osimertinib), initially demonstrated a partial response with a 57% reduction in tumor volume after completion of the HARMONIC™ lead-in cohort enrollment in Q3 of 2024. The patient subsequently demonstrated a complete response in the target cancer lesions, specifically the lung and adrenal gland lesions by Q1 of 2025. This type of complete response in the target cancer lesions is atypical for this advanced and recurrent NSCLC after multiple rounds of therapy. "This remarkable case exemplifies several of the things we have hoped to observe with LP-300 in the HARMONIC trial," said Panna Sharma, President and CEO of Lantern Pharma. "To see a heavily pre-treated patient not only achieve a complete response in their target cancer lesions but maintain that response with excellent quality of life is truly extraordinary. This outcome provides important confirmation of our data and AI-driven approach to drug development and gives us growing confidence as we advance toward potential future registration-enabling studies for this underserved patient population that has no approved treatment options after failing targeted kinase therapies." Notably, the patient has shown no clinically significant adverse drug reactions or dose-limiting toxicities (DLTs) over 21 cycles of treatment. By February 2025, imaging showed continued complete response in the primary target lesions with only scar tissue remaining at the site of the lung cancer lesions, and the disappearance of the adrenal gland cancer lesion, demonstrating the profound and durable nature of the therapeutic response. Growing Global Cancer Type with No Approved Options After Kinase Therapy FailureThe proportion of never-smoking patients with non-small cell lung cancer (NSCLC) has been significantly increasing globally over the past 30 years, from 15% in the 1970s to 33% in the 2000s. Lung cancer in never smokers is the fifth leading cause of cancer-related deaths globally, according to the International Agency for Research on Cancer (IARC). Never-smokers represent a distinct subset of lung cancer patients1 with unique genetic profiles and limited treatment options, estimated to represent a $4+ billion annual market opportunity globally. The HARMONIC™ trial is evaluating LP-300, advanced with Lantern's proprietary RADR® AI platform, in combination with pemetrexed and carboplatin in never-smokers with advanced NSCLC who have progressed after treatment with tyrosine kinase inhibitors (TKIs). Exceptional Clinical Observations in a Challenging Patient Population With Significant Unmet NeedsThis case represents a particularly significant observation given the patient's extensive treatment history, including with both immuno-oncology agents and targeted kinase therapies, and the challenging nature of advanced NSCLC in non-responsive never-smokers. The sustained response over nearly two years, combined with excellent tolerability, underscore LP-300's potential to be a transformative treatment option for this underserved patient population and is demonstrative of the mechanistic rationale for this drug-candidate. "The sustained response we're observing in this patient, particularly after three lines of prior standard of care treatments, is remarkable and provides strong support for LP-300's therapeutic potential," said Dr. Reggie Ewesuedo, Vice President of Clinical Development at Lantern Pharma. "The fact that this patient has tolerated 21 cycles of treatment without clinically significant adverse drug reactions and has achieved meaningful durable response reinforces our confidence in the promise of this drug-candidate in this patient population." About Lantern Pharma's HARMONIC™ TrialThe HARMONIC™ clinical trial is a Phase 2 study (NCT05456256) evaluating LP-300 in combination with standard chemotherapy (pemetrexed/carboplatin) for never-smokers with advanced lung adenocarcinoma who have experienced progression or intolerance to prior tyrosine kinase inhibitor (TKI) therapy. The trial is designed to assess whether LP-300, when added to chemotherapy, improves progression-free survival (PFS) and overall survival (OS) compared to the current standard-of-care chemotherapy doublet alone. The multicenter, open-label, randomized study has planned enrollment of approximately 90 patients across sites in the United States, Japan, and Taiwan. The trial compares LP-300 in combination with standard-of-care chemotherapy versus chemotherapy alone in a 2:1 randomization, with co-primary endpoints of progression-free survival (PFS) and overall survival (OS). Upcoming Milestones and Clinical DevelopmentLantern expects to continue reporting clinical updates from the HARMONIC trial throughout 2025 as enrollment progresses across multiple sites. The company anticipates providing an additional data update from the randomized expansion phase in the second half of 2025. The never-smoker NSCLC population represents a significant and growing unmet medical need, with no therapies specifically approved for this patient subset. Approximately 15-20% of all lung cancer patients in the U.S. are never-smokers, with significantly higher rates in Asian populations, where up to 50% of new lung cancer diagnoses occur in never-smokers. About LP-300LP-300 was advanced with Lantern's proprietary RADR® AI platform to aid in the confirmation of combination synergies and the proposed mechanism of action. The lead-in cohort of the Phase 2 HARMONIC trial demonstrated an initial 86% clinical benefit rate and 43% objective response rate, leading to the current randomized expansion phase.2 About Lantern PharmaLantern Pharma (NASDAQ: LTRN) is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development. The company's proprietary AI and machine learning platform, RADR®, leverages over 200 billion oncology-focused data points and a library of 200+ advanced ML algorithms to help solve real-world problems in oncology drug development. By harnessing the power of AI and with input from world-class scientific advisors and collaborators, Lantern has accelerated the development of its growing pipeline of therapies that span multiple cancer indications, including both solid tumors and blood cancers. 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 $2.5 million per program. Please find more information at: Website: Harmonic Trial: LinkedIn: X: @lanternpharma Forward-Looking StatementsThis 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; 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 or on the SEC's website at 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. _____________________________1 Lung cancer in patients who have never smoked — an emerging disease - Jan 9, 2024 — 2 LP-300 Plus Chemo Yields Early Efficacy Results in Never-Smokers With NSCLC - Aug 5, 2024 — View source version on Contacts Investor Contact Investor Relationsir@ +1 972-277-1136 Sign in to access your portfolio
Business Wire
15-05-2025
- Business
- Business Wire
Lantern Pharma Reports First Quarter 2025 Financial Results and Business Updates
DALLAS--(BUSINESS WIRE)--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. "This 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 AI-Powered Drug Development Pipeline Highlights: LP-300 Lantern's 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. Phase 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. LP-184 LP-184 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). Phase 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. RADR ® A.I. Platform: 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 cancer. 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, 2025, compared to approximately $24.0 million as of December 31, 2024. R&D Expenses: Research and development expenses were approximately $3.3 million for the quarter ended March 31, 2025, compared to approximately $4.3 million for the quarter ended March 31, 2024. G&A Expenses: General and administrative expenses were approximately $1.5 million for the quarter ended March 31, 2025, essentially unchanged from approximately $1.5 million for the quarter ended March 31, 2024. Net Loss: Net loss was approximately $4.5 million (or $0.42 per share) for the quarter ended March 31, 2025, compared to a net loss of approximately $5.4 million (or $0.51 per share) for the quarter ended March 31, 2024. 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, to focus exclusively on the clinical execution of our promising therapies for CNS and brain cancers, many of which have no effective treatment options. Our AI-driven pipeline of innovative product candidates is estimated to have a combined annual market potential of over $15 billion USD and have the potential to provide life-changing therapies to hundreds of thousands of cancer patients across the world. 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; 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 or on the SEC's website at 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 and its technologies, clinical developments, licensing matters and other matters through a variety of means, including Lantern Pharma's 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.
Yahoo
15-05-2025
- Business
- Yahoo
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, May 15, 2025--(BUSINESS WIRE)--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. "This 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 AI-Powered Drug Development Pipeline Highlights: LP-300 Lantern's 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. Phase 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. LP-184 LP-184 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). Phase 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. RADR® A.I. Platform: 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 cancer. 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, 2025, compared to approximately $24.0 million as of December 31, 2024. R&D Expenses: Research and development expenses were approximately $3.3 million for the quarter ended March 31, 2025, compared to approximately $4.3 million for the quarter ended March 31, 2024. G&A Expenses: General and administrative expenses were approximately $1.5 million for the quarter ended March 31, 2025, essentially unchanged from approximately $1.5 million for the quarter ended March 31, 2024. Net Loss: Net loss was approximately $4.5 million (or $0.42 per share) for the quarter ended March 31, 2025, compared to a net loss of approximately $5.4 million (or $0.51 per share) for the quarter ended March 31, 2024. 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, to focus exclusively on the clinical execution of our promising therapies for CNS and brain cancers, many of which have no effective treatment options. Our AI-driven pipeline of innovative product candidates is estimated to have a combined annual market potential of over $15 billion USD and have the potential to provide life-changing therapies to hundreds of thousands of cancer patients across the world. 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; 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 or on the SEC's website at 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 and its technologies, clinical developments, licensing matters and other matters through a variety of means, including Lantern Pharma's 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 Contacts Investor Relationsir@ (972) 277-1136
Business Wire
05-05-2025
- Business
- Business Wire
Lantern Advances Drug Candidate LP-184 with IND Clearance for Phase 1b/2 Clinical Trial in Triple Negative Breast Cancer (TNBC)
DALLAS--(BUSINESS WIRE)--Lantern Pharma Inc. (Nasdaq: LTRN), an artificial intelligence company developing targeted and transformative cancer therapies using its proprietary AI platform, RADR ®, today announced that it has received clearance of its Investigational New Drug Application (IND) from the U.S. Food and Drug Administration (FDA) for a Phase 1b/2 clinical trial for LP-184 in Triple Negative Breast Cancer. This achievement builds on the previous regulatory momentum including Orphan Drug Designation in 2023 and Fast Track Designation in 2024 1. "This IND clearance for LP-184 in a Phase 1b/2 study represents a pivotal advancement in our mission to bring precisely targeted, AI-developed medicines to patients with aggressive cancers and limited treatment options," said Panna Sharma, CEO & President. Share Strategic Trial Design to Address Critical Treatment Gap in TNBC The innovative dual-approach in the clinical trial is designed to evaluate LP-184 in recurrent, advanced-stage TNBC patients through: Monotherapy Arm: An open-label study involving approximately 30 patients with advanced-stage TNBC, focusing on dose optimization to evaluate, enhance and optimize safety and potential efficacy for TNBC patients. Combination Therapy: Evaluation of LP-184 in combination with olaparib in second-line settings for patients with advanced-stage TNBC harboring BRCA1 or BRCA2 alterations, with primary endpoints including safety and efficacy parameters that could potentially support a pathway to regulatory approval. This strategic approach focuses on addressing a significant unmet medical need, with average survival for newly diagnosed metastatic TNBC estimated at 10 to 18 months, representing an annual market opportunity exceeding $4 billion USD. LP-184 Background in TNBC & Mechanistic Rationale LP-184 is a synthetically lethal small molecule that induces DNA double strand breaks upon bioactivation by the enzyme prostaglandin reductase 1 (PTGR1) in cancer cells. Preclinical studies and artificial intelligence-driven in silico modeling suggest that cancers with DDR gene alterations may preferentially respond to LP-184. 2 Preclinical findings also suggest that LP-184 is particularly well positioned for TNBC with striking data from in vivo models including complete regression seen in several PARP resistant as well as PARP sensitive PDXs (see Figure 1). Nearly 70% of TNBCs are noted to harbor deficiency in homologous recombination pathways, making them likely to be particularly sensitive tumors for targeting with drug-candidate LP-184. In addition, it is estimated that up to 46% percent of women with TNBC will develop brain metastasis 3, and LP-184 has shown blood brain barrier (BBB) penetration, with evidence of activity in preclinical brain metastasis models. LP-184 Phase 1b/2 TNBC Trial Overview - Monotherapy The monotherapy phase 1b/2 trial is designed to evaluate LP-184 in patients with advanced-stage TNBC. The study is designed to focus on dose optimization to evaluate and enhance both safety and potential efficacy ultimately aiding in the potential determination of the best clinical position for LP-184 in advanced-stage TNBC patients. The design of the dose optimization phase, provides for evaluation of the safety, efficacy and pharmacokinetics of LP-184 using 2 dose levels in an open-label monotherapy study involving around 30 patients to be dosed with LP-184. LP-184 Phase 1b/2 TNBC Trial Overview - Combination Therapy with PARP inhibitor LP-184 has also been shown in preclinical studies to be highly potent in combination with the PARP inhibitor, olaparib, including in tumors that are resistant to PARP inhibitors. In preclinical studies, treatment of a HBCx-28 TNBC PDX model, with BRCA-1 LOH and an HRD score of 63 that was resistant to the PARP inhibitor, showed evidence of re-sensitization in combination with LP-184 (See Figure 2). These data, which were initially presented at the San Antonio Breast Cancer Symposium, support the clinical evaluation of LP-184 in combination with PARPi in an earlier line of treatment. Treating patients in an earlier clinical setting has the potential to reach more patients and potentially generate a more durable and deeper earlier control of the disease. The design of the combination phase 1b/2 trial provides for LP-184 to be evaluated in a second-line setting in patients with advanced-stage TNBC whose primary tumor harbors alterations in BRCA1 or BRCA2. The primary end points of the study are expected to include safety and efficacy, with the aim of supporting a potential pathway to a regulatory approval process. Multi-Region Clinical Strategy with Focus on High-Incidence Countries The trials are planned to be conducted at select centers in the United States as well as academic cancer centers and institutions in India and Nigeria, where TNBC incidence rates are particularly high—comprising nearly 40% of initial breast cancer diagnoses. This strategic site selection is focused on leveraging established collaborative research networks that have a track record of successful collaborative cancer studies with US and European pharma companies. Lantern's planned objective will be to ensure proper local experience and support for this clinical trial while addressing regions with significant disease burden and high clinical demand. "This IND clearance for LP-184 in a Phase 1b/2 study represents a pivotal advancement in our mission to bring precisely targeted, AI-developed medicines to patients with aggressive cancers and limited treatment options," said Panna Sharma, CEO and President of Lantern Pharma. "The strategic design of our clinical program reflects both the compelling mechanistic rationale and the encouraging data supporting LP-184's potential in TNBC." Expanding Therapeutic Potential Across Multiple Indications Beyond TNBC, LP-184 shows promise for the potential treatment of other cancers harboring DNA damage repair mutations, including lung, bladder, pancreatic, and ovarian cancers. Additional clinical trials in these targeted indications are in planning stages, with several being considered as Investigator Initiated Trials. LP-184 has received multiple Orphan Drug, Fast Track, and Rare Pediatric Disease Designations from the FDA across various solid tumor indications. The global TNBC market is estimated at $3-5 billion USD annually, with over 300,000 new cases diagnosed worldwide each year. While homologous recombination deficient TNBCs are often initially treated with PARP inhibitors, resistance inevitably develops, underscoring the critical need for novel therapeutic approaches. 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 100 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 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 Phase 1 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, many of which have no effective treatment options. Our AI-driven pipeline of innovative product candidates is estimated to have a combined annual market potential of over $15 billion USD and have the potential to provide life-changing therapies to hundreds of thousands of cancer patients across the world. 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; 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 or on the SEC's website at 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.
