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Lantern Pharma Reports Additional Positive LP-184 Phase 1a Results Showing Durable Disease Control in Heavily Pre-Treated Advanced Cancer Patients as Company Advances Precision Oncology Program into Multiple Biomarker-Guided Phase 1b/2 Trials
Businesswire· 2025-12-03 13:35
Core Insights - Lantern Pharma Inc. has reported positive results from its Phase 1a dose-escalation study of LP-184, demonstrating durable disease control in patients with advanced solid tumors, particularly those with DNA damage repair (DDR) pathway deficiencies [1][2] - The company is advancing a precision oncology strategy with multiple biomarker-guided Phase 1b/2 clinical trials targeting triple-negative breast cancer (TNBC), glioblastoma multiforme (GBM), non-small cell lung cancer (NSCLC), and advanced urothelial carcinoma, with an estimated market opportunity exceeding $10 billion annually [1][2] Phase 1a Clinical Trial Results - The Phase 1a trial enrolled 63 heavily pre-treated patients, achieving a 54% disease control rate at therapeutic dose levels, indicating promising activity in DDR-deficient cancers [1][2] - The recommended Phase 2 dose (RP2D) was established at 0.39 mg/kg, with a favorable safety profile characterized by manageable adverse events [1][2] - Over 87% of patients exceeded the PTGR1 bioactivation threshold, validating the biomarker's utility for patient selection [1][2] Patient Durability and Efficacy - Notable patient cases included individuals with stage 4 cancers who have shown ongoing clinical benefits for over 12 to 23 months after treatment with LP-184, highlighting its potential in difficult-to-treat cancers [1][2] - The drug demonstrated activity in both homologous recombination (HR)-deficient and nucleotide excision repair (NER)-deficient tumors, suggesting a broader patient applicability compared to existing therapies [2] Regulatory Support and Designations - LP-184 has received multiple FDA designations, including Fast Track and Orphan Drug designations for various cancers, which facilitate accelerated development and potential expedited approval pathways [2][3] - These designations enhance the company's ability to interact with the FDA and may allow for rolling submissions of New Drug Application (NDA) sections [2] Future Development Plans - Lantern Pharma is planning multiple biomarker-guided Phase 1b/2 trials, including combinations with other therapies for TNBC, NSCLC, and GBM, targeting high unmet medical needs [2][3] - The company is also exploring additional indications, such as post-radiation pancreatic cancer, which may benefit from enhanced PTGR1 expression due to prior treatments [2][3] Company Overview - Lantern Pharma is a clinical-stage biotechnology company focused on using artificial intelligence and genomic data to develop precision oncology therapies [3] - The company's RADR® AI platform integrates extensive data to identify biomarkers and predict drug responses, streamlining the drug development process [3]
2 sub‑$10 AI stocks to outperform Palantir in 2026, according to ChatGPT‑5
Finbold· 2025-11-23 19:58
Core Insights - Palantir Technologies (NASDAQ: PLTR) has established itself as a leader in AI-driven data analytics, securing significant government contracts and expanding its intelligence business, resulting in a 105% stock price increase year-to-date, trading at $154 [1][2] Company Summaries BigBear.ai (NYSE: BBAI) - BigBear.ai is undergoing a strategic pivot, highlighted by its acquisition of Ask Sage, a generative AI platform for secure sectors like defense, which is expected to generate approximately $25 million in annual recurring revenue in 2025 [3][5] - The acquisition positions BigBear to transition from a decision-intelligence contractor to a full-stack generative AI provider, enhancing its offerings for government clients [4] - With over $450 million in cash, BigBear has the financial flexibility to support growth initiatives and strategic investments, potentially allowing it to carve out a unique position in the defense AI sector [5][6] Lantern Pharma (NASDAQ: LTRN) - Lantern Pharma utilizes its RADR AI platform to innovate oncology drug development, leveraging over 200 billion data points and 200 machine-learning algorithms [7] - The company has shown promising clinical results, with a 48% clinical benefit rate in its LP-184 Phase 1a trial among heavily pretreated patients [8][9] - Lantern is managing its cash effectively, with $19.7 million available, and plans to commercialize parts of its RADR platform, which could generate revenue through licensing [9]
Lantern Pharma Inc. (LTRN) Discusses LP-184 Phase 1a Clinical Results and Implications for DNA Damage Repair-Deficient Tumors Transcript
Seeking Alpha· 2025-11-21 01:33
Core Insights - The webinar focuses on the clinical trial results of LP-184, a drug aimed at treating advanced solid tumors [1][2] - Key participants include the CEO, Chief Scientific Officer, Head of Clinical Development, and a collaborator from Fox Chase [2] - The discussion will cover the scientific background, early development, and clinical results of LP-184 [1][3] Company Overview - LP-184 is primarily targeted for the treatment of advanced solid tumors, particularly those that are deficient in certain characteristics [3] Clinical Development - The presentation will delve into the early development of LP-184 and its scientific basis [1][2] - A Q&A session is planned to address audience inquiries regarding the trial and the drug [2]
Lantern Pharma (NasdaqCM:LTRN) Update / Briefing Transcript
2025-11-20 22:32
Lantern Pharma (NasdaqCM:LTRN) Update Summary Company Overview - **Company**: Lantern Pharma - **Drug**: LP-184 - **Focus**: Treatment of advanced solid tumors, particularly those with DNA damage repair deficiencies Key Points Industry and Drug Development - LP-184 is primarily aimed at treating advanced solid tumors, including triple-negative breast cancer (TNBC), glioblastoma (GBM), and bladder cancer, which often exhibit deficiencies in DNA damage repair pathways [2][3] - The drug has completed Phase IA trials with promising safety and tolerability data, showing significant clinical activity across various solid tumor types [3][25] - Lantern Pharma has received three orphan drug designations and two fast-track designations for LP-184, indicating strong market potential [3] Mechanism of Action - LP-184 is designed to exploit synthetic lethality, particularly in tumors with high levels of PTGR1, a gene that enhances the drug's efficacy [4][10] - The drug works by causing double-stranded breaks in DNA, which are particularly lethal to tumor cells deficient in DNA repair mechanisms [4][18] - Tumors with mutations in nucleotide excision repair and homologous recombination pathways show heightened sensitivity to LP-184 [13][14] Clinical Trial Results - The Phase IA study demonstrated a favorable safety profile, with most adverse events being grade 1 or 2 and manageable [31] - Out of 63 enrolled patients, 52 were available for tumor response assessment, with 28 patients achieving stable disease, including four with durable responses lasting over six months [34] - Notably, 87.5% of patients had PTGR1 expression levels sufficient for LP-184 activation, supporting the drug's precision medicine approach [41] Future Clinical Development - Planned Phase IB and II trials will focus on advanced monotherapy and combination therapies, particularly in TNBC and non-small cell lung cancer [26][42] - The trials will utilize a Bayesian adaptive design to expedite the process and improve patient outcomes [28] - There is a strong emphasis on biomarker-driven studies to identify patients most likely to benefit from LP-184 [46] Market Potential - The market for LP-184 is considered exceptional, with estimates suggesting that about 20% of cancers harbor DNA damage repair deficiencies, making them potential candidates for treatment [3][4] - The drug's ability to combine with other therapies, such as PARP inhibitors, positions it as a strong contender in the oncology market [54][55] Additional Insights - LP-184 has shown potential in overcoming resistance to existing therapies, including PARP inhibitors, and may also convert "cold" tumors to "hot" tumors for immunotherapy [15][54] - The drug's ability to cross the blood-brain barrier is particularly advantageous for treating brain metastases associated with TNBC [57] Conclusion - Lantern Pharma's LP-184 represents a promising advancement in the treatment of solid tumors with DNA repair deficiencies, supported by strong preclinical and early clinical data. The ongoing trials and strategic focus on precision medicine could significantly impact patient outcomes and market positioning in oncology [60]
Lantern Pharma Inc. 2025 Q3 - Results - Earnings Call Presentation (NASDAQ:LTRN) 2025-11-15
Seeking Alpha· 2025-11-15 23:50
Group 1 - The article does not provide any specific content or key points related to a company or industry [1]
Lantern Pharma(LTRN) - 2025 Q3 - Earnings Call Transcript
2025-11-13 15:02
Financial Data and Key Metrics Changes - R&D expenses decreased to approximately $2.4 million for Q3 2025 from $3.7 million in Q3 2024, primarily due to reductions in clinical trial support and consulting expenses [38] - General and administrative expenses increased to approximately $1.9 million in Q3 2025 from $1.5 million in the prior year, attributed to higher business development and investor relations costs [38] - The net loss for Q3 2025 was approximately $4.2 million, or $0.39 per share, compared to a net loss of approximately $4.5 million, or $0.42 per share in Q3 2024 [39] Business Line Data and Key Metrics Changes - The LP-184 phase 1a clinical trial achieved a 48% clinical benefit rate in evaluable cancer patients, demonstrating significant tumor reductions in patients with specific DNA-damage repair mutations [5][10] - Preliminary phase II data from the LP-300 Harmonic trial showed an 86% clinical benefit rate, with one patient demonstrating a durable complete response lasting nearly two years [21] Market Data and Key Metrics Changes - The combined annual market potential for the targeted indications of LP-184 exceeds $7 billion, focusing on triple-negative breast cancer, non-small cell lung cancer, bladder cancer, and recurrent GBM [17] - The market opportunity for lung cancer in never-smokers is approaching $4 billion annually, with no current therapies approved for this demographic [19] Company Strategy and Development Direction - The company is focused on integrating AI and machine learning into drug development, positioning itself as a leader in precision oncology [4][36] - The RADR AI platform is being commercialized, with eight distinct AI-powered modules developed to address critical pain points in oncology drug development [27][36] - The introduction of the Zeta platform aims to streamline rare cancer research and drug development by integrating fragmented data sources into a cohesive AI system [30][34] Management's Comments on Operating Environment and Future Outlook - Management highlighted the transformative nature of the past quarter, achieving multiple clinical, regulatory, and validation milestones [5] - The company expects to continue advancing its clinical assets while scaling its AI platform for commercial deployment, emphasizing a dual engine strategy [43] Other Important Information - As of September 30, 2025, the company had approximately $12.4 million in cash, cash equivalents, and marketable securities, providing a runway into Q3 2026 [39] - The company entered into an ATM sales agreement to offer and sell up to $15.53 million of its common stock, raising approximately $989,000 during Q3 2025 [40] Q&A Session Summary Question: Tracking toward an interim event analysis for the LP-300 trial - Management indicated that they do not believe they will reach the 31 events required for the analysis, which is positive as it suggests patients are remaining on the trial longer [44] Question: Status of the Denmark trial - The Denmark trial has been approved, with IRBs set and a project manager assigned, expected to start in late December or early January [45] Question: IND submission for the pediatric CNS program - Management confirmed readiness to submit the IND for the pediatric CNS program in the coming weeks [45] Question: Updates on the Zeta platform - The Zeta platform is expected to have an early rollout with demos available to collaborators and partners, with broader rollout planned for Q1 2026 [46] Question: Indications for LP-184 - Management plans to identify the most impactful indications for larger scale trials, with interest from pharmaceutical companies [47] Question: Development of Zeta - Zeta was initially developed to address rare cancers, with the goal of providing a comprehensive tool for drug developers [48]
Lantern Pharma(LTRN) - 2025 Q3 - Earnings Call Transcript
2025-11-13 15:02
Financial Data and Key Metrics Changes - R&D expenses decreased to approximately $2.4 million in Q3 2025 from $3.7 million in Q3 2024, primarily due to reductions in clinical trial support and consulting expenses [38] - General and administrative expenses increased to approximately $1.9 million in Q3 2025 from $1.5 million in the prior year, attributed to higher business development and investor relations costs [38] - The net loss for Q3 2025 was approximately $4.2 million, or $0.39 per share, compared to a net loss of approximately $4.5 million, or $0.42 per share in Q3 2024 [39] Business Line Data and Key Metrics Changes - The LP-184 phase I-A clinical trial achieved a 48% clinical benefit rate in evaluable cancer patients, validating the AI-driven precision medicine approach [5][10] - The LP-300 Harmonic trial showed an 86% clinical benefit rate in preliminary data, with one patient demonstrating a durable complete response for nearly two years [21] - The LP-284 program for recurrent non-Hodgkin's lymphoma generated interest from biopharma companies, showcasing a complete metabolic response in a heavily pretreated patient [23] Market Data and Key Metrics Changes - The combined annual market potential for the targeted indications of LP-184 exceeds $7 billion, focusing on triple-negative breast cancer, non-small cell lung cancer, bladder cancer, and recurrent GBM [17] - The market opportunity for the LP-300 trial in never-smokers with lung cancer is approaching $4 billion annually, with no current approved therapies for this demographic [19] - The LP-284 program has a global market opportunity of about $3 billion, targeting aggressive recurrent non-Hodgkin's lymphoma [22] Company Strategy and Development Direction - The company is focused on integrating AI and machine learning into drug discovery and development, positioning itself as a leader in precision oncology [4] - The RADR AI platform is being commercialized, with eight distinct AI-powered modules developed to address critical pain points in oncology drug development [27] - The introduction of the Zeta platform aims to streamline rare cancer research and drug development, enhancing the efficiency of identifying treatment options [30][34] Management's Comments on Operating Environment and Future Outlook - Management highlighted the transformative nature of the past quarter, achieving significant clinical, regulatory, and validation milestones [5] - The company expects to continue advancing its clinical assets while scaling its AI platform for commercial deployment, emphasizing a dual engine strategy [43] - Management expressed confidence in the potential of their AI tools and services, projecting significant standalone market potential in the future [36] Other Important Information - The company had approximately $12.4 million in cash, cash equivalents, and marketable securities as of September 30, 2025, providing a runway into Q3 2026 [39] - The company entered into an ATM sales agreement to offer and sell up to $15.53 million of its common stock, raising approximately $989,000 during Q3 2025 [40] Q&A Session Summary Question: What is the status of the interim event analysis for the LP-300 trial? - Management indicated that they do not believe they will reach the 31 events required for the analysis by December, which is positive as it suggests patients are remaining on the trial longer [45] Question: What is the timeline for the Denmark trial? - The Denmark trial has been approved, and management expects it to start in late December or early January [45] Question: What is the status of the IND submission for the pediatric CNS program? - Management confirmed that they are prepared to submit the IND for the pediatric CNS program in the coming weeks [46] Question: What can be expected from the Zeta platform? - Management mentioned that Zeta will be rolled out in phases, with early demos available to collaborators and partners, and broader rollout expected in Q1 2026 [46] Question: How will the indications for LP-184 be prioritized? - Management plans to evaluate which indications yield the biggest impact and move those into larger scale trials, ideally with partners [47]
Lantern Pharma(LTRN) - 2025 Q3 - Earnings Call Transcript
2025-11-13 15:00
Financial Data and Key Metrics Changes - R&D expenses decreased to approximately $2.4 million in Q3 2025 from $3.7 million in Q3 2024, primarily due to reductions in clinical trial support and consulting expenses [35] - General and administrative expenses increased to approximately $1.9 million in Q3 2025 from $1.5 million in the prior year, attributed to higher business development and investor relations costs [35] - The net loss for Q3 2025 was approximately $4.2 million, or $0.39 per share, compared to a net loss of approximately $4.5 million, or $0.42 per share in Q3 2024 [36] Business Line Data and Key Metrics Changes - The LP-184 phase 1a clinical trial achieved a 48% clinical benefit rate in evaluable cancer patients, validating the AI-driven precision medicine approach [5][11] - Preliminary phase II data from the LP-300 Harmonic trial showed an 86% clinical benefit rate, with one patient demonstrating a durable complete response for nearly two years [20][21] - The LP-284 program targeting recurrent non-Hodgkin's lymphoma generated interest from biopharma companies, showcasing a complete metabolic response in a heavily pretreated patient [23] Market Data and Key Metrics Changes - The combined annual market potential for the targeted indications of LP-184 exceeds $7 billion, with specific opportunities in triple-negative breast cancer, non-small cell lung cancer, bladder cancer, and recurrent GBM [17] - The market opportunity for the LP-300 program in lung cancer among never-smokers is approaching $4 billion annually, with no current approved therapies for this demographic [19] - The LP-284 program has a global market opportunity of about $3 billion, focusing on patients with aggressive recurrent non-Hodgkin's lymphoma [22] Company Strategy and Development Direction - The company is focused on integrating AI and machine learning into drug discovery and development, positioning itself as a leader in precision oncology [4][39] - The RADR AI platform is being commercialized, with eight distinct AI-powered modules developed to address critical pain points in oncology drug development [26][34] - The introduction of the Zeta platform aims to streamline rare cancer research and drug development, enhancing decision-making and reducing costs [30][32] Management's Comments on Operating Environment and Future Outlook - Management highlighted the transformative nature of the past quarter, achieving significant clinical, regulatory, and validation milestones [5] - The company expects to continue advancing its clinical assets while scaling its AI platform for commercial deployment, emphasizing a dual engine strategy [39][40] - Management expressed confidence in the potential of their AI tools and services to represent several hundred million dollars in standalone market potential [34] Other Important Information - As of September 30, 2025, the company had approximately $12.4 million in cash, cash equivalents, and marketable securities, providing a runway into approximately Q3 2026 [36] - The company entered into an ATM sales agreement to offer and sell up to $15.53 million of its common stock, raising approximately $989,000 during Q3 2025 [37] Q&A Session Summary Question: Update on interim event analysis for the LP-300 trial - Management indicated that they do not expect to reach the 31 events required for analysis until early 2026, which is seen as positive news as it suggests patients are remaining on the trial longer [41] Question: Status of the Denmark trial - The Denmark trial has been approved, with IRBs set and a project manager assigned, expected to start in late December or early January [42] Question: IND submission for the pediatric CNS program - Management confirmed readiness to submit the IND for the pediatric CNS program in the coming weeks [42] Question: Details on the Zeta platform - The Zeta platform is expected to have an interesting and bumpy early rollout, with internal usage already underway and plans for broader rollout in Q1 [43] Question: Indications for LP-184 - Management plans to identify the most impactful indications for larger scale trials, with interest from pharmaceutical companies [44]
Lantern Pharma(LTRN) - 2025 Q3 - Earnings Call Presentation
2025-11-13 14:00
Third Quarter 2025 Operating & Financial Results Conference Call / Webinar Nov 13th, 2025 9AM Eastern Time NASDAQ :LTRN Forward Looking Statements This presentation 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 o ...
Lantern Pharma(LTRN) - 2025 Q3 - Quarterly Results
2025-11-13 13:30
Clinical Trials and Drug Development - LP-184 Phase 1a clinical trial achieved a 48% clinical benefit rate in evaluable cancer patients at or above the therapeutic dose threshold, with marked tumor reductions in patients with specific DNA damage repair mutations[2] - The FDA Type C meeting provided regulatory guidance for Starlight Therapeutics' planned pediatric CNS cancer trial, confirming the combination strategy with spironolactone[8] - LP-300 Phase 2 HARMONIC™ trial is ongoing, evaluating the drug in combination with standard chemotherapy for NSCLC patients who have progressed after TKI therapy[10] - The Company plans to initiate a Pediatric CNS cancer trial in Q1 2026 and LP-184 Phase 1b/2 trials in TNBC and NSCLC, subject to funding[29] - Lantern Pharma's AI platform, RADR, utilizes over 200 billion oncology-focused data points to enhance drug discovery and development efficiency[30] - The Company will host a KOL scientific webinar on November 20, 2025, to discuss LP-184 Phase 1a results and clinical development strategy[29] Financial Performance - Lantern Pharma has approximately $12.4 million in cash, cash equivalents, and marketable securities as of September 30, 2025, down from approximately $24.0 million at the end of 2024, providing an operating runway into approximately Q3 2026[20] - R&D expenses decreased to approximately $2.4 million for Q3 2025, compared to approximately $3.7 million for Q3 2024, primarily due to reductions in research studies and materials[21] - General and Administrative expenses increased to approximately $1.9 million for Q3 2025, up from approximately $1.5 million for Q3 2024, driven by higher business development and investor relations expenditures[22] - Net loss for Q3 2025 was approximately $4.2 million (or $0.39 per share), compared to a net loss of approximately $4.5 million (or $0.42 per share) for Q3 2024[23] - Operating expenses for Q3 2025 totaled $4,349,800, a decrease from $5,179,576 in Q3 2024, indicating a 16% reduction year-over-year[40] - The net loss for Q3 2025 was $4,177,423, compared to a net loss of $4,505,697 in Q3 2024, showing a 7% improvement[40] - As of September 30, 2025, total current assets decreased to $13,461,005 from $25,247,629 as of December 31, 2024, reflecting a significant reduction[38] - The Company reported a cash and cash equivalents balance of $8,389,486 as of September 30, 2025, up from $7,511,079 at the end of 2024[38] - The weighted-average number of common shares outstanding for Q3 2025 was 10,833,393, slightly increasing from 10,763,351 in Q3 2024[40] Strategic Initiatives - The Company entered into an ATM Sales Agreement allowing the sale of up to $15,530,000 of common stock, with $989,061 raised from 212,444 shares sold in Q3 2025[25] - Lantern Pharma expects to scale up commercial efforts for its AI platform and prepare for potential capital formation activities to support clinical advancements in 2026[29] - The RADR AI platform demonstrated a 94.1% accuracy for blood-brain barrier permeability prediction, addressing a critical pharmaceutical challenge[18] - LP-284 has received multiple FDA Orphan Drug Designations, highlighting its potential in treating aggressive lymphomas[14] - The company is advancing development plans for LP-184 in high-value indications, with a combined market potential exceeding $7 billion annually[2]