Phase II Trial of LP-300 in Combination With Carboplatin and Pemetrexed in Never Smoker Patients With Relapsed Advanced Primary Adenocarcinoma of the Lung After Treatment With Tyrosine Kinase Inhibitors (The HARMONIC Study)

The goal of this clinical trial is to determine clinical advantages for LP-300 in combination with carboplatin and pemetrexed in the never smoker patient population. The primary objectives of this study are to determine progression-free survival (PFS) and overall survival (OS) in the study-defined patient population when LP-300 is co-administered with the standard of care chemotherapy drugs carboplatin and pemetrexed compared to carboplatin and pemetrexed alone. This has been designed as a multicenter, open label, phase II trial with 90 patients to be enrolled in the United States.

Start Date01 Mar 2023

Sponsor / Collaborator

Lantern Pharma, Inc.

NCT00966914

/ CompletedPhase 3

Randomized, Multicenter, Double-blind, Phase 3 Trial of Tavocept Versus Placebo in Patients With Newly Diagnosed or Relapsed Advanced Primary Adenocarcinoma of the Lung Treated With Docetaxel or Paclitaxel Plus Cisplatin

Tavocept is an investigational drug that is being developed to see if it can increase the survival of patients who are being treated with chemotherapy as well as to see if it can prevent or reduce side effects of chemotherapy. This research study is aimed at trying to find out if people with advanced adenocarcinoma of the lung who are treated with a standard combination of chemotherapy drugs will live longer if they are also treated with an investigational drug called "Tavocept." Another objective of this research study is to find out whether or not Tavocept helps to prevent or reduce side-effects like kidney damage, anemia, and nausea and vomiting that can occur with these drug combinations. The drug combinations that will be used in this research study will include either paclitaxel and cisplatin, or docetaxel and cisplatin. These drug combinations are approved to be used to treat people with advanced NSCLC. Every patient on this research study will be treated with standard chemotherapy for primary NSCLC in the form of either docetaxel or paclitaxel (these will be recommended by your research study doctor), which will be given in combination with cisplatin.

Start Date01 Apr 2010

Sponsor / Collaborator

BioNumerik Pharmaceuticals, Inc.

[+1]

NCT00077311

/ CompletedPhase 2IIT

A Phase II Randomized Study Of Dose-Dense Docetaxel And Cisplatin Every Two Weeks With Pegfilgrastim And Darbepoetin Alfa With And Without The Chemoprotector BNP7787 In Patients With Advanced Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dimesna, may help prevent or decrease the side effects (such as nerve, kidney, and inner ear damage) caused by chemotherapy.
PURPOSE: This randomized phase II trial is studying giving docetaxel and cisplatin together with dimesna to see how well it works compared to giving docetaxel and cisplatin alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Start Date01 Aug 2004

Sponsor / Collaborator

Alliance Foundation Trials LLC

[+1]

100 Clinical Results associated with Dimesna

100 Translational Medicine associated with Dimesna

100 Patents (Medical) associated with Dimesna

271

Literatures (Medical) associated with Dimesna

01 Sep 2025·Clinical Lung Cancer

Article

Author: Lee, Chun-Hui ; Zhou, Jianli ; Makimoto, Go ; Goto, Yasushi ; Subramanian, Janakiraman ; Abdulla, Nihal ; Luo, Yung-Hung ; Dowell, Jonathan ; Wen, Yueh-Feng ; Ewesuedo, Reginald ; Asahina, Hajime ; Bodor, J Nicholas ; Miyauchi, Eisaku ; Konduri, Kartik ; Sankhala, Kamlesh ; Murakami, Shuji ; Chang, Shan Yueh ; Lee, Eric ; Treat, Joseph

INTRODUCTION:

Most patients with non-small cell lung cancer (NSCLC) who have never smoked possess tumors bearing tyrosine kinase oncogenes. While such tumors may exhibit robust responses to front-line tyrosine inhibitors (TKIs), disease progression is inevitable. Subsequent available therapies confer limited benefit, thus developing effective treatments for these patients remains a critical need. LP-300 is a novel compound that enhances chemotherapy sensitivity and inhibits the activity of tyrosine kinase oncogenes. Retrospective subset analyses of prior phase III studies found females and never-smokers, groups likely to have oncogene-driven tumors, obtained a considerable survival advantage with LP-300 combined with platinum-based chemotherapy as compared to chemotherapy alone. Prospective validation of these findings in patients with oncogene-driven NSCLC is needed.

METHODS:

The HARMONIC clinical trial, which is currently in progress, is a global, randomized, phase II study (NCT05456256) evaluating the 3-drug regimen of LP-300 with pemetrexed and carboplatin versus pemetrexed and carboplatin alone in 90 patients with advanced primary lung adenocarcinoma bearing tyrosine kinase oncogenes. Patient randomization is stratified by gender and favors the LP-300 containing arm (2-1). Patients must have tumors bearing tyrosine kinase actionable alterations (i.e. EGFR, ALK, ROS1, MET, RET, BRAF, or NTRK) and have prior TKI progression or intolerance. Primary endpoints are progression-free survival (PFS) and overall survival (OS). Secondary endpoints include objective response rate, duration of objective response, clinical benefit rate, and incidence of adverse events.

CONCLUSION:

This phase II trial is accruing patients at sites in the U.S, Japan, and Taiwan. Patient accrual is expected to be completed in the Fall of 2026.

01 Aug 2025·DNA REPAIR

DNA topoisomerase IIß inhibition blocks DNA end resection and synergizes with PARPi in BRCA1-deficient models

Article

Author: Rodríguez-Real, Guillermo ; Huertas, Pablo ; Camarillo, Rosa ; Cruz-García, Andrés ; Jimeno, Sonia ; Serra, Violeta ; Herencia-Ropero, Andrea ; Prados-Carvajal, Rosario

DNA end resection is a critical step that governs how a broken chromosome will be repaired. As such, it is heavily regulated by multiple cellular signals and processes. Alterations in the regulation of DNA end resection have consequences for cell survival upon exposure to cytotoxic agents, including those used during cancer chemotherapy. Here, we identified several small molecules that affect the process of DNA end resection. Among them, we focus on determining the mode of action of merbarone, a DNA topoisomerase II inhibitor. We uncover a role of the topoisomerase IIβ isoform in the full processing of DNA breaks. Moreover, we show that the effect of merbarone is affected by the formation of G4 quadruplexes and that BRCA1-deficient cancer cells are sensitive to merbarone. Strikingly, this sensitivity can be partially suppressed in cell lines expressing hypomorphic versions of BRCA1 lacking exon 11, a hypomorph that has been linked to PARPi-resistance. Using cellular models, we show that PARPi- and merbarone-resistant BRCA1 exon 11 mutant cells, but not wildtype BRCA1 cells, are sensitive to the combination of both drugs. Finally, we show that combination of merbarone and the PARPi olaparib has a mild antitumor effect in a PARPi-resistant PDX model bearing a BRCA1 exon 11 mutation.

15 Jul 2025·ENVIRONMENTAL SCIENCE & TECHNOLOGY

The Clumped Isotope Signatures of Multiple Methanogenic Metabolisms

Article

Author: Morra, Kaycee ; Feng, Xiahong ; Cobban, Alec ; Rizzo, Gabriella ; M. Jetten, Mike S. ; Fogel, Marilyn ; Guibourdenche, Laetitia ; Young, Edward D. ; Ash, Jeanine L. ; Thompson, Mia ; Lin, Ying ; Berger, Stefanie ; Mueller, Elliott P. ; Kubik, Briana C. ; Torres, Mark A. ; Masterson, Andrew L. ; Stein, Rebekah ; Li, Jiawen ; Leavitt, William D. ; Welte, Cornelia U. ; Martini, Anna ; Holden, James F.

Methane is a potent greenhouse gas, an important energy source, and an important part of the global carbon cycle. The relative abundances of doubly substituted ("clumped") methane isotopologues (¹³CH₃D and ¹²CH₂D₂) offer important information on the sources and sinks of methane. However, the clumped isotope signatures of microbially produced methane from different methanogenic pathways lack a systematic investigation. In this study, we provide a data set encompassing isotopic signatures of hydrogenotrophic, methylotrophic, acetoclastic, and methoxydotrophic methanogenesis. We find that a statistical "combinatorial effect" generates significant differences in ¹²CH₂D₂ compositions between hydrogenotrophic methanogenesis and the other pathways, while variations in the fractionation factors of clumped isotopologues result in differences in ¹³CH₃D compositions between the methylotrophic, acetoclastic, and methoxydotrophic pathways. The energy yield of methanogenesis and the energy conservation approaches implemented by different microbial strains may also influence the isotope values of methane. Further analysis suggests that previously observed isotopic signatures of methane in freshwater environments are potentially due to mixing between hydrogenotrophic and other methanogenesis pathways. This study provides new experimental constraints on the isotope signatures of different microbial methanogenic pathways and evidence of the mechanisms responsible for the observed differences. This enables a better understanding of the sources and sinks of methane in the environment.

News (Medical) associated with Dimesna

31 Mar 2026

·www.biospace.com

Lantern Pharma Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Updates

Year of Clinical Validation and Strategic Expansion Across Pipeline, AI Platform Advances Towards Commercialization, and Global Trial Milestones LP-300 Phase 2 HARMONIC™ Trial Progress: Continued enrollment and patient follow-up across the United States, Japan, and Taiwan. Completion of targeted enrollment in Japan across five clinical sites including the National Cancer Center Tokyo. Preliminary data presented at the 66th Annual Meeting of the Japan Lung Cancer Society. Type C meeting package submitted to FDA in March 2026, with meeting scheduled for mid-May 2026 seeking feedback on proposed protocol amendments including focusing enrollment on EGFR exon 21 L858R patients and updating the LP-300 dosing schedule to allow for up to 8 cycles of treatment. The treatment of never-smokers with NSCLC represents an estimated $4+ billion annual market opportunity with no specifically approved therapies. LP-184 Phase 1a Completion and Expansion: All primary endpoints achieved with 48% clinical benefit rate at or above therapeutic dose threshold; additional positive results reported in Q4 2025 demonstrating durable disease control in heavily pre-treated advanced cancer patients. Biomarker-guided Phase 1b/2 trials planned in TNBC, NSCLC with KEAP1/STK11 mutations, and an investigator-led clinical study in Denmark in PTGR1 overexpressing bladder cancers with DNA damage repair mutations. Starlight Therapeutics IND Clearance: FDA clears IND for planned Phase 1 pediatric CNS cancer trial of STAR-001 in Atypical Teratoid Rhabdoid Tumor (ATRT) and other rare pediatric cancers, marking a pivotal regulatory milestone for Lantern’s wholly-owned subsidiary. LP-284 Orphan Drug Designation: LP-284 receives FDA Orphan Drug Designation for soft tissue sarcomas, adding to existing designations for mantle cell lymphoma and high-grade B-cell lymphomas. Complete metabolic response in therapeutically exhausted DLBCL patient presented at 25th LL&M Congress. AI-Driven Pipeline: Lantern’s portfolio of clinical-stage drug candidates, spanning lung cancer, breast cancer, lymphoma, sarcoma, pediatric brain cancers, and bladder cancer, represents a combined estimated annual market potential exceeding $15 billion, with multiple programs positioned to advance towards Phase 1b/2 and Phase 2 value-creation milestones in 2026. RADR® AI Platform Global Expansion: Initiation of AI Center of Excellence in India to industrialize the RADR® platform and accelerate global biopharma development opportunities. Presentation at 7th Glioblastoma Drug Development Summit in Boston. withZeta.ai — Multi-Agentic Co-Scientist Platform: Introduction of withZeta.ai, a first-of-its-kind multi-agentic AI co-scientist platform designed to accelerate drug development insights and therapeutic strategies across more than 438 rare cancers. Since late December 2025, withZeta.ai has been in active demo and beta testing with over 25 biotech companies, cancer research centers, and biopharma consultants, representing a significant near-term commercialization opportunity for the Company’s AI capabilities. Financial Position: Approximately $10.1 million in cash, cash equivalents, and marketable securities as of December 31, 2025. Conference call and webcast scheduled for Monday, March 30, 2026 at 4:30 p.m. ET. 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 fourth quarter and full year 2025 ended December 31, 2025, and provided an update on its portfolio of AI-driven drug candidates and AI platforms, RADR® and withZeta.ai. “2025 was a defining year for Lantern Pharma as we achieved clinical validation across multiple programs while establishing the foundation for our next phase of growth,” said Panna Sharma, CEO & President of Lantern Pharma. “The encouraging and developing LP-300 Phase 2 HARMONIC™ observations, combined with successful Phase 1a completion for LP-184 and FDA IND clearance for our pediatric CNS cancer program through Starlight Therapeutics, represent transformational milestones that validate and strengthen our AI-driven approach to precision oncology. Our full-year results reflect disciplined execution with a 19% reduction in total operating expenses year-over-year, even as we advanced multiple clinical programs through key inflection points and introduced a highly unique multi-agentic system aimed at conquering rare cancers. As we move into 2026, we are positioning to advance multiple high-value clinical programs, expand our RADR® platform’s commercial reach and revenue potential globally through our new AI Center of Excellence in India and strengthen our balance sheet.” Clinical Pipeline Developments Lantern’s AI-driven clinical pipeline encompasses multiple drug candidates across solid tumors, blood cancers, and pediatric oncology, with a combined estimated annual market potential exceeding $15 billion. The portfolio includes a Phase 2 clinical program (LP-300), multiple programs advancing toward Phase 1b/2 trials (LP-184), an ongoing Phase 1 trial in hematologic malignancies (LP-284), and a planned Phase 1 pediatric CNS cancer trial (STAR-001) through Starlight Therapeutics. Each program has been guided by the RADR® platform’s AI-driven insights. On average, our newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in 2–3 years and at approximately $1.0–2.5 million per program. LP-300 HARMONIC™ Trial: Continued Progress and Strategic Momentum The Phase 2 HARMONIC™ trial continued to advance through the fourth quarter and into early 2026, with ongoing patient enrollment and follow-up across clinical sites in the United States, Japan, and Taiwan. The trial evaluates LP-300 in combination with standard-of-care chemotherapy (carboplatin + pemetrexed) in never-smokers with NSCLC adenocarcinoma who have progressed after tyrosine kinase inhibitor (TKI) therapy. Key Milestones: Japan Enrollment Completed: In July 2025, Lantern completed targeted enrollment in Japan ahead of schedule across five clinical sites including the National Cancer Center Tokyo, validating the company’s strategic expansion into regions with significantly higher rates of never-smoker NSCLC. Data Presented at JLCS: During Q4 2025, clinical investigators presented data from the ongoing HARMONIC™ trial at the 66th Annual Meeting of the Japan Lung Cancer Society, including results from both Asian and U.S. patient cohorts. Safety Lead-In Results: The trial has previously demonstrated encouraging results in its initial safety lead-in cohort, showing an 86% clinical benefit rate and 43% objective response rate among the first seven patients enrolled in the United States, including one patient who achieved a durable complete response in target cancer lesions with survival continuing for nearly two years. Enrollment Progress: The trial continues to enroll patients in Taiwan, where more than 50% of lung cancer cases occur in never-smokers, and across U.S. sites. FDA Engagement — Type C Meeting: In March 2026, Lantern submitted a Type C meeting package to the FDA regarding the ongoing Phase 2 HARMONIC™ study. The meeting, currently scheduled for mid-May 2026, seeks FDA feedback and concurrence on proposed protocol amendments to the study. The proposed amendments to the HARMONIC™ study include: (i) focusing future enrollment to patients with EGFR exon 21 L858R mutation (a subtype of tyrosine kinase mutations); (ii) increasing the maximum number of LP-300 treatment cycles from six to eight; and (iii) converting the current randomized study design to a Phase 2 single-arm Simon two-stage study by discontinuing enrollment into the control arm. The proposed amendments are supported by a preliminary analysis of study data suggesting that patients with the EGFR exon 21 L858R mutation may derive greater clinical benefit from the LP-300 triplet regimen; the evolution of the treatment landscape for TKI-refractory NSCLC that has made continued randomization to the control arm increasingly challenging; and historical safety data indicating that up to eight cycles of LP-300 at the current dose level did not alter the established safety pro the drug. There can be no assurance that the FDA will concur with the proposed amendments, and any changes to the study protocol will be subject to FDA review and clearance during and after the Type C meeting planned for mid-May. Lantern is actively exploring collaboration and partnering opportunities both globally and regionally to maximize LP-300’s commercial potential in multiple geographies. Additional clinical data updates from the HARMONIC™ trial are expected in the first half of 2026. Never-smoker NSCLC is increasingly recognized as a distinct disease entity with unique clinical and genomic characteristics, representing a global market opportunity estimated at over $4 billion annually. Currently, there are no therapies specifically approved for never-smoker NSCLC patients. LP-184: Phase 1a Completion and Advancement Toward Phase 1b/2 Trials In Q4 2025, Lantern reported additional positive LP-184 Phase 1a results showing durable disease control in heavily pre-treated advanced cancer patients as the company is positioning to advance its precision oncology program into multiple biomarker-guided Phase 1b/2 trials. The Phase 1a trial (NCT05933265), which enrolled 63 patients, achieved all primary endpoints with a 48% clinical benefit rate at or above the therapeutic dose threshold and provided further confirmation of LP-184’s unique mechanism of action. Key Phase 1a Highlights: Biomarker Validation: Marked tumor reductions observed in patients with DNA damage repair mutations including CHK2, ATM, BRCA1, and STK11/KEAP1 alterations, validating RADR®-driven insights regarding the mechanism of LP-184. Recommended Phase 2 Dose: Successfully established RP2D of 0.39mg/kg with favorable safety profile. Activity in Difficult-to-Treat Cancers: Notable clinical benefits in glioblastoma multiforme (GBM), gastrointestinal stromal tumor (GIST), and thymic carcinoma. Phase 1b/2 Development Plans (subject to additional funding): Triple-Negative Breast Cancer (TNBC): Phase 1b/2 study targeting a potential annual market exceeding $4 billion. NSCLC with STK11/KEAP1 Co-mutations: Biomarker-guided study, potential annual market approaching $1.5 billion. Investigator Led Study: Bladder Cancer: Investigator-led clinical study planned to initiate in Denmark in PTGR1 overexpressing bladder cancers with DNA damage repair mutations. Starlight Therapeutics: FDA IND Clearance for Pediatric CNS Cancer Trial In early 2026, the FDA cleared the IND for Starlight Therapeutics’ planned Phase 1 pediatric CNS cancer trial of STAR-001 (LP-184) in Atypical Teratoid Rhabdoid Tumor (ATRT) and other rare pediatric cancers. STAR-001 has received both Rare Pediatric Disease Designation and Orphan Drug Designation from the FDA for ATRT, along with additional designations for hepatoblastoma, rhabdomyosarcoma, and malignant rhabdoid tumors. These designations provide potential pathways for FDA Priority Review Vouchers (PRVs) upon a potential approval. PRVs have historically been sold or transferred for significant value, with recent transactions in the range of $100 million to $150 million or more, representing a potentially meaningful source of non-dilutive value for Lantern and its shareholders independent of the commercial potential of the underlying therapy. The Rare Pediatric Disease Designation for ATRT, hepatoblastoma, rhabdomyosarcoma, and malignant rhabdoid tumors each independently qualifies for a potential PRV upon potential FDA approval and meeting other program conditions. LP-284: Orphan Drug Designation and Clinical Advancement In Q1 2026, LP-284 received FDA Orphan Drug Designation for soft tissue sarcomas, adding to existing designations for mantle cell lymphoma and high-grade B-cell lymphomas. In Q4 2025, Lantern presented clinical data at the 25th LL&M Congress showcasing a confirmed complete metabolic response in a heavily pretreated DLBCL patient. LP-284 benefits from composition of matter patents providing protection through 2039 in the majority of the major medicine markets (USA, EU, Japan, China, India, Mexico, Korea, and Australia). RADR® AI Platform: Global Expansion and Commercial Momentum AI Center of Excellence in India In early 2026, Lantern announced the initiation of an AI Center of Excellence in India to industrialize and grow the RADR® platform, the withZeta.ai system and accelerate global development opportunities with biopharma companies looking to leverage AI as a service. withZeta.ai: Multi-Agentic Co-Scientist Platform for Rare Cancers A key commercial milestone in late 2025 was the introduction of withZeta.ai, a first-of-its-kind multi-agentic AI co-scientist platform. withZeta.ai is designed to accelerate drug development insights, therapeutic strategy generation, cancer trial development and research workflows across more than 438 rare cancers — a category of diseases that collectively represents a massive unmet medical need but where individual indications have historically been underserved due to small patient populations, sparse and scattered data and limited commercial incentives. The platform leverages Lantern’s unique expertise and proprietary data assets in rare and orphan cancer drug development, combining multiple specialized AI agents that work collaboratively to analyze genomic data, identify potential therapeutic targets, predict drug-tumor interactions, and generate actionable development strategies. Since late December 2025, withZeta.ai has been in active demo and beta testing with over 25 biotech companies, cancer research centers, and biopharma consultants, generating significant interest and early engagement from the industry. withZeta.ai represents a meaningful near-term commercialization opportunity for Lantern, as the platform is designed to generate recurring revenue through subscription and usage-based licensing models while reinforcing the company’s position as a leader in AI-driven oncology drug development. The company expects to provide further updates on commercial traction and partnership discussions related to withZeta.ai throughout 2026. withZeta.ai: Market Opportunity, Scaling Strategy, and Vision The withZeta.ai platform is architected to first address the unique challenges of rare cancer drug development, where fragmented data, small patient populations, and limited institutional knowledge have historically made therapeutic development economically and scientifically prohibitive. By aggregating and structuring insights across 438+ rare cancers into a unified AI co-scientist framework, withZeta.ai provides pharmaceutical and biotech researchers with capabilities that would otherwise require large, specialized teams and years of manual analysis. Lantern’s longer term plan is to scale withZeta.ai beyond rare cancers into broader oncology indications and, subsequently, into rare diseases and other therapeutic areas through revenue generating collaborations with pharmaceutical companies. The platform’s multi-agentic architecture is designed to be extensible — the same collaborative AI agent framework that powers rare cancer insights can be configured and trained to address drug development challenges across neurology, immunology, metabolic diseases, and other complex therapeutic areas where data fragmentation and scientific complexity represent significant barriers to R&D productivity. The global rare disease therapeutics market is projected to exceed $300 billion by 2028, and the broader pharmaceutical R&D outsourcing and AI-enabled drug discovery market represents an additional multi-billion-dollar opportunity. Lantern believes that withZeta.ai is positioned at the intersection of these high-growth markets, with a differentiated offering that combines proprietary oncology data, validated AI algorithms, and a practical co-scientist user experience designed for bench scientists and clinical development teams. “2026 can be a critical year for the commercialization of our AI platforms to support broad-based drug development and scientific productivity in R&D,” said Mr. Sharma. “We are building for a future where AI co-scientists are commonplace in knowledge work across the pharmaceutical and biotech industries — augmenting human expertise, accelerating discovery timelines, and dramatically improving the economics of drug development. We believe this represents a potential near-term market opportunity of $20 to $50 billion, and withZeta.ai is our first agentic-based commercial product designed to capture a meaningful share of that market. The early engagement from a broad range of organizations in our beta program validates both the demand and the differentiation of our approach.” Other AI Platform Highlights predictBBB.ai: 94.1% accuracy for blood-brain barrier permeability prediction; five of top eleven positions on the Therapeutic Data Commons Leaderboard. This tool has been significantly enhanced to encompass a wider range of molecular and structural analysis aimed at molecules and medicines. LBx-AI Liquid Biopsy: 86% accuracy for predicting treatment response in NSCLC; 0.76 Pearson correlation for PD-L1 level inference from ctDNA. R&D Investment by Program (Full Year 2025): For the year ended December 31, 2025, our approximate research and development costs by project were: LP-300 ($4.6M), LP-184 ($4.3M), LP-284 ($1.2M), RADR® Platform ($1.0M), and other programs ($0.4M), totaling approximately $11.5 million. Addressing Fake News on Company CEO & Leadership The company was made aware of an online third-party article unaffiliated with the company stating that the CEO of Lantern was stepping down and had resigned. This was a false and misleading article that seemed to be focused on shorting the Company’s stock price amongst traders. Panna Sharma continues to serve as President and Chief Executive Officer with the full confidence of the Board of Directors, and together with the management team, continues to actively lead the company’s day-to-day operations, clinical development strategy, partnership discussions, and capital planning efforts. Lantern Pharma encourages its investors and stakeholders to rely on the company’s SEC filings, press releases, and official communications through its established disclosure channels for genuine information about the company and its leadership. Financial Results for Fourth Quarter and Full Year 2025 Balance Sheet: Cash, cash equivalents, and marketable securities were approximately $10.1 million as of December 31, 2025 (consisting of approximately $4.4 million in cash and cash equivalents and approximately $5.7 million in marketable securities), compared to approximately $24.0 million as of December 31, 2024. The company believes that its existing cash, cash equivalents, and marketable securities will enable it to fund anticipated operating expenses and capital expenditure requirements until at least approximately late July 2026 to mid September 2026. The company will need to obtain substantial additional funding in the near future and it is actively evaluating and pursuing potential funding alternatives. Full Year 2025 Results: Research and Development Expenses: R&D expenses were approximately $11.5 million for the year ended December 31, 2025, compared to approximately $16.1 million for the year ended December 31, 2024, a decrease of approximately $4.6 million or 29%. The decrease was primarily attributable to decreases in research studies and materials of approximately $4,034,000 relating to clinical trials, decreases in payroll and compensation expenses of approximately $610,000, and decreases in consulting expenses of approximately $81,000, partially offset by increases in licensing expenses of approximately $113,000. General and Administrative Expenses: G&A expenses were approximately $6.5 million for the year ended December 31, 2025, compared to approximately $6.1 million for the year ended December 31, 2024, an increase of approximately $373,000 or 6%. The increase was primarily attributable to increases in business development and investor relations expenditures of approximately $436,000, increases in patent costs of approximately $55,000, and increases in corporate insurance expenses of approximately $51,000, offset in part by decreases in payroll and compensation expenses of approximately $115,000. Net Loss: Net loss was approximately $17.1 million (or $1.57 per share) for the year ended December 31, 2025, compared to a net loss of approximately $20.8 million (or $1.93 per share) for the year ended December 31, 2024, representing a year-over-year reduction of net loss of approximately $3.7 million or 18%. Fourth Quarter 2025 Results: Total Operating Expenses: Total operating expenses were approximately $4.2 million for the quarter ended December 31, 2025, compared to approximately $5.9 million for the quarter ended December 31, 2024. Q4 2025 R&D expenses were approximately $2.7 million compared to approximately $4.3 million in Q4 2024. Q4 2025 G&A expenses were approximately $1.5 million compared to approximately $1.6 million in Q4 2024. Net Loss: Net loss was approximately $4.1 million for the quarter ended December 31, 2025, compared to a net loss of approximately $5.9 million for the quarter ended December 31, 2024. Capitalization: As of December 31, 2025, the Company had 11,254,697 shares of common stock outstanding, and options to purchase 1,296,126 shares of common stock at a weighted average exercise price of $5.58 per share were outstanding. As of December 31, 2025, there were no warrants outstanding. In July 2025, the Company entered into an ATM Sales Agreement with ThinkEquity LLC, pursuant to which the Company may offer and sell up to $15,530,000 of its common stock in “at-the-market” offerings. During the year ended December 31, 2025, the Company sold 356,922 shares under the ATM for gross proceeds of $1,624,547. Lantern Pharma Inc. and Subsidiaries Consolidated Balance Sheets December 31, 2025 December 31, 2024 CURRENT ASSETS Cash and cash equivalents $4,422,838 $7,511,079 Marketable securities 5,696,386 16,501,984 Prepaid expenses & other current assets 683,948 1,234,566 Total current assets 10,803,172 25,247,629 Property and equipment, net 31,875 47,440 Operating lease right-of-use assets 75,595 239,985 Deferred offering costs 88,431 — Other assets 36,738 36,738 TOTAL ASSETS $11,035,811 $25,571,792 CURRENT LIABILITIES Accounts payable and accrued expenses $4,423,048 $4,140,361 Operating lease liabilities, current 78,539 190,814 Total current liabilities 4,501,587 4,331,175 Operating lease liabilities, non-current — 52,843 TOTAL LIABILITIES 4,501,587 4,384,018 STOCKHOLDERS’ EQUITY Common Stock 1,125 1,078 Additional paid-in capital 99,652,724 97,058,323 Accumulated other comprehensive income 25,430 153,990 Accumulated deficit (93,145,055) (76,025,617) Total stockholders’ equity 6,534,224 21,187,774 TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY $11,035,811 $25,571,792 Contacts Investor Contact Investor Relations ir@lanternpharma.com +1-972-277-1136 Read full story here

Phase 2Phase 1Clinical ResultOrphan Drug

10 Feb 2026

·www.businesswire.com

Lantern Pharma to Present at the 7 th Glioblastoma Drug Development Summit in Boston on February 17-19, 2026

DALLAS--(BUSINESS WIRE)--Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company leveraging artificial intelligence to accelerate oncology drug discovery and development, today announced that CEO and President Panna Sharma will present at the 7th Glioblastoma Drug Development Summit, February 17–19, 2026, in Boston, MA. More information about the summit is available at: https://glioblastoma-drugdevelopment.com. Lantern’s proprietary AI and machine learning platform, RADR®, powered the development of LP-184 / STAR-001, a novel brain-penetrant therapeutic candidate. This work has driven the creation of Lantern’s wholly owned subsidiary, Starlight Therapeutics, which is advancing clinical development for multiple CNS cancers, including recurrent glioblastoma and pediatric brain tumors such as atypical teratoid/rhabdoid tumors (ATRT)—for which STAR-001 has received both FDA Orphan Drug Designation and Rare Pediatric Disease Designation. In his presentation on Day Two (Thursday, February 19, 2026, at 10:30 a.m. ET), Mr. Sharma will highlight how Lantern applied RADR® to: Elucidate the mechanism of action of STAR-001 Identify patient biomarkers to inform clinical use Select optimal cancer indications Discover novel combination therapies in neuro-oncology The talk will emphasize AI-driven insights and approaches that are helping overcome challenges in treating aggressive brain cancers like glioblastoma and ATRT. About Lantern Pharma Lantern Pharma (NASDAQ: LTRN) is a clinical-stage biotechnology company using artificial intelligence, machine learning, and genomic data to streamline oncology drug development and bring precision therapies to patients who need them. The company's proprietary RADR® AI platform integrates hundreds of billions of data points to identify biomarkers, predict drug response, and design smarter clinical trials. Lantern's clinical-stage pipeline includes LP-184, LP-284, and LP-300, each targeting genomically defined patient populations. For more information, visit www.lanternpharma.com. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other things, statements relating to: future events or our future financial performance; the potential advantages of our RADR® platform in identifying drug candidates and patient populations that are likely to respond to a drug candidate; potential partnerships and collaborations; our strategic plans to advance the development of our drug candidates; estimates regarding the development timing for our drug candidates; expectations and estimates regarding clinical trial timing and patient enrollment; our research and development efforts of our internal drug discovery programs and the utilization of our RADR® platform to streamline the drug development process; our intention to leverage artificial intelligence, machine learning and genomic data to streamline and transform the pace, risk and cost of oncology drug discovery and development and to identify patient populations that would likely respond to a drug candidate; estimates regarding patient populations, potential markets and potential market sizes; sales estimates for our drug candidates and our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others. Any statements that are not statements of historical fact (including, without limitation, statements that use words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “model,” “objective,” “aim,” “upcoming,” “should,” “will,” “would,” or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the risk that we may not be able to secure sufficient future funding when needed and as required to advance and support our existing and planned clinical trials and operations, (ii) the risk that observations in preclinical studies and early or preliminary observations in clinical studies do not ensure that later observations, studies and development will be consistent or successful, (iii) the risk that our research and the research of our collaborators may not be successful, (iv) the risk that we may not be successful in licensing potential candidates or in completing potential partnerships and collaborations, (v) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates, (vi) the risk that no drug product based on our proprietary RADR® AI platform has received FDA marketing approval or otherwise been incorporated into a commercial product, and (vii) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on March 27, 2025. You may access our Annual Report on Form 10-K for the year ended December 31, 2024 under the investor SEC filings tab of our website at http://www.lanternpharma.com/ or on the SEC’s website at http://www.sec.gov/. Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this press release represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations.

Orphan Drug

20 Jan 2026

·www.biospace.com

Lantern Pharma’s LP-284 Receives FDA Orphan Drug Designation for Soft Tissue Sarcomas

Third FDA orphan designation for LP-284; Sixth overall for Lantern’s A.I.-driven precision oncology pipeline Orphan designation expands LP-284's potential for an estimated ~96,000 global annual soft tissue sarcoma cases; annual market valued at $2.4 billion in 2025 and projected to reach $4.7 billion by 2035 DALLAS--(BUSINESS WIRE)--Lantern Pharma Inc. (NASDAQ: LTRN), a clinical-stage biopharmaceutical company using artificial intelligence to transform the cost, pace, and timeline of oncology drug discovery and development, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to LP-284 for the treatment of soft tissue sarcomas. This marks the third orphan designation for LP-284, following previous orphan designations in Mantle Cell Lymphoma (MCL) in January 2023 and High-Grade B-Cell Lymphoma (HGBL) with MYC and BCL2 rearrangements in November 2023. It is the sixth overall orphan designation granted to Lantern Pharma's clinical programs. " Receiving orphan drug designation for LP-284 in soft tissue sarcomas expands this molecule’s potential beyond hematologic malignancies into solid tumors, " said Panna Sharma, CEO of Lantern Pharma. " Adult soft tissue sarcomas are a compelling opportunity for LP-284. Unlike pediatric sarcomas driven by specific gene fusions, adult sarcomas commonly exhibit complex genomic alterations, chromosomal instability, and DNA damage response deficiencies – including BRCA-ness and homologous recombination repair defects – that align with LP-284's synthetic lethal mechanism. With over 79% of cases occurring in adults, this designation addresses a distinct patient population with significant unmet need. Our RADR® AI platform identified these DNA repair vulnerabilities, demonstrating its ability to uncover biomarker-driven precision oncology opportunities in rare cancers with limited treatment options. " Significant Unmet Need in Soft Tissue Sarcomas, a Global Market of ~96,000 Annual Cases with Limited Treatment Options Soft tissue sarcomas are a diverse group of rare cancers that develop in the tissues that connect, support, and surround other body structures, including muscle, fat, blood vessels, nerves, tendons, and the lining of joints. According to the National Cancer Institute's SEER Program, approximately 13,520 new cases of soft tissue sarcoma are expected to be diagnosed in the United States in 2025. Over 79% of soft tissue sarcoma cases occur in patients 40 years of age or older. 1 Globally, soft tissue sarcoma represents a significant health burden with approximately 96,200 new cases diagnosed worldwide in 2021, according to the Global Burden of Disease Study. The seven major pharmaceutical markets (United States, France, Germany, Italy, Spain, United Kingdom, and Japan) for soft tissue sarcoma therapeutics reached a value of approximately $2.4 billion in 2025 and are projected to reach approximately $4.7 billion by 2035. 2 Adult soft tissue sarcomas exhibit distinct molecular characteristics compared to pediatric sarcomas. While pediatric sarcomas are largely driven by specific gene fusions, adult sarcomas more commonly harbor complex genomic alterations, chromosomal instability, and DNA repair deficiencies that may be susceptible to agents that target DNA repair pathways. 3 According to the Sarcoma Foundation of America’s 2025 Sarcoma Statistics , treatment options for advanced or metastatic soft tissue sarcomas remain limited, with five-year survival rates for distant disease at approximately 16-17%, representing a significant unmet medical need in adult oncology. AI-Predicted & Clinically Observed Synthetic Lethal Mechanism of LP-284 Targets DNA Repair Deficiencies LP-284 is a novel small molecule with a synthetic lethal mechanism targeting DNA repair deficiencies via transcription-coupled nucleotide excision repair (TC-NER). A member of the acylfulvene class, LP-284 has demonstrated promising activity across multiple cancer types in preclinical studies and early clinical development, with observed activity regardless of TP53 mutation status or surface antigen expression. In July 2025, Lantern reported that LP-284 achieved a complete metabolic response in a heavily pretreated patient with aggressive diffuse large B-cell lymphoma (DLBCL) in its ongoing Phase 1 clinical trial. The 41-year-old patient had previously failed three aggressive treatment regimens including standard chemo-immunotherapy, CAR-T cell therapy, and CD3xCD20 bispecific antibody therapy – representing a therapeutically exhausted patient population. Following enrollment in April 2025, the patient achieved complete metabolic response with non-avid lesions after completing just two 28-day cycles of LP-284, providing support for the drug's synthetic lethal mechanism and demonstrating meaningful clinical activity in a patient with one of the most challenging hematologic malignancies. This clinical milestone is particularly significant as it demonstrates LP-284's ability to induce responses in patients who have exhausted advanced immunotherapies, addressing a critical treatment gap in relapsed/refractory cancers. The mechanism of action – targeting DNA repair deficiencies through TC-NER – is similarly applicable to adult soft tissue sarcomas, which commonly harbor complex genomic alterations and DNA repair pathway defects. LP-284 is currently being evaluated in a Phase 1 clinical trial (NCT06132503) for B-cell non-Hodgkin lymphomas, including MCL and HGBL. With three orphan designations spanning both hematologic malignancies and solid tumors, LP-284 represents a versatile therapeutic development candidate with potential applications across diverse cancer types characterized by DNA repair vulnerabilities. Strategic Regulatory Pathway: Orphan Drug Designation Provides 7 Years of Exclusivity & Benefits Accelerated Development The FDA's Orphan Drug Designation program provides incentives for the development of drugs intended to treat rare diseases affecting fewer than 200,000 people in the United States. Benefits of orphan drug designation include seven years of market exclusivity upon regulatory approval, tax credits for qualified clinical trials, exemption from FDA user fees, and FDA assistance in clinical trial design. 4 About Lantern Pharma Lantern Pharma (NASDAQ: LTRN) is a clinical-stage biotechnology company using artificial intelligence, machine learning, and genomic data to streamline oncology drug development and bring precision therapies to patients who need them. The company's proprietary RADR® AI platform integrates hundreds of billions of data points to identify biomarkers, predict drug response, and design smarter clinical trials. Lantern's clinical-stage pipeline includes LP-184, LP-284, and LP-300, each targeting genomically defined patient populations. For more information, visit . 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; potential partnerships and collaborations; our strategic plans to advance the development of our drug candidates; estimates regarding the development timing for our drug candidates; 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 Global burden of soft tissue sarcomas in 204 countries and territories from 1990 to 2021: data from the global burden of disease study 2021. BMC Public Health. 2025. 2 Soft Tissue Sarcoma Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2024-2034. IMARC Group. 3 National Institutes of Health. Gene Fusions in Pediatric Sarcomas. PA-16-251. 4 U.S. Food and Drug Administration. Orphan Drug Designation Program. Contacts Investor Contact Investor Relations ir@lanternpharma.com +1-972-277-1136

ImmunotherapyOrphan DrugPhase 1Clinical ResultCell Therapy

100 Deals associated with Dimesna

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced Lung Adenocarcinoma	Phase 3	United States	BioNumerik Pharmaceuticals, Inc.	01 Apr 2010
Advanced Lung Adenocarcinoma	Phase 3	Bulgaria	BioNumerik Pharmaceuticals, Inc.	01 Apr 2010
Advanced Lung Adenocarcinoma	Phase 3	Poland	BioNumerik Pharmaceuticals, Inc.	01 Apr 2010
Advanced Lung Adenocarcinoma	Phase 3	Romania	BioNumerik Pharmaceuticals, Inc.	01 Apr 2010
Advanced Lung Adenocarcinoma	Phase 3	Russia	BioNumerik Pharmaceuticals, Inc.	01 Apr 2010
Advanced Lung Adenocarcinoma	Phase 3	Ukraine	BioNumerik Pharmaceuticals, Inc.	01 Apr 2010
Bronchioloalveolar Adenocarcinoma	Phase 3	United States	BioNumerik Pharmaceuticals, Inc.	01 Apr 2010
Bronchioloalveolar Adenocarcinoma	Phase 3	Bulgaria	BioNumerik Pharmaceuticals, Inc.	01 Apr 2010
Bronchioloalveolar Adenocarcinoma	Phase 3	Poland	BioNumerik Pharmaceuticals, Inc.	01 Apr 2010
Bronchioloalveolar Adenocarcinoma	Phase 3	Romania	BioNumerik Pharmaceuticals, Inc.	01 Apr 2010

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00077311 (CALGB 30303, Pubmed \| J Thorac Oncol)	Phase 2	Advanced Lung Non-Small Cell Carcinoma	160	Dose-dense docetaxel and cisplatin without BNP7787	tqfmbskgdy(myehuxxmpd) = yblfncwvdz caaftjvpwg (pagxstozub ) View more	-	01 Oct 2008
				Dose-dense docetaxel and cisplatin with BNP7787	tqfmbskgdy(myehuxxmpd) = bgckzqvexk caaftjvpwg (pagxstozub ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Hiro LS Researcher

The AI Search Engine Built to Accelerate Biopharma Decisions

Search across billion-scale life sciences data to uncover signals, validate evidence, and act with confidence.

Ask any biopharma research question→

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, Patsnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Discover Synapse Data Servers

Synapse data is now integrated into the PatSnap LS Model Context Protocol (MCP) service. Customize your LLM agent now using our MCP server!

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis