Financial Data and Key Metrics Changes - The company reported a net loss of approximately $5.9 million for Q4 2024, compared to a net loss of approximately $4.2 million in Q4 2023, reflecting a loss per share increase from $0.39 to $0.54 [62] - For the full year 2024, R&D expenses were approximately $16.1 million, up from approximately $11.9 million in 2023, primarily due to increased research studies and payroll expenses [63] - The total cash position as of December 31, 2024, was approximately $24 million, which is expected to fund operations for at least 12 months [65] Business Line Data and Key Metrics Changes - All clinical stage drug candidates are now in Phase 1 and Phase 2 trials, with significant progress reported in the clinical pipeline and AI platform [12][14] - The Phase 2 asset LP-300 has seen accelerated enrollment, particularly in Japan and Taiwan, where the incidence of non-small cell lung cancer among never smokers is significantly higher [17][70] - The lead cohort for LP-300 achieved an 86% clinical benefit rate and a 43% objective response rate in never smoker non-small cell lung cancer patients [15] Market Data and Key Metrics Changes - The company is expanding its geographic strategy to Japan and Taiwan, where 33% to 40% of non-small cell lung cancer cases occur in never smokers, compared to just 15% in the U.S. [17] - The market potential for LP-300 is estimated to be between $4 billion to $5 billion annually, with a growing opportunity in the targeted population [14] Company Strategy and Development Direction - The company emphasizes the innovative use of AI and machine learning to transform oncology drug discovery and development, aiming for significant returns for investors and patients [8] - The strategic expansion into Asia is expected to enhance enrollment rates and generate robust data sets for clinical trials [17][70] - The company is focused on advancing its product candidates and pipeline, with a strong emphasis on R&D expenses exceeding G&A expenses [63] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the transformative potential of AI in drug development, highlighting the efficiency and cost-effectiveness of their approach [68][76] - The company anticipates multiple value-creating milestones throughout the year, with the potential to deliver transformative therapies for patients with limited treatment options [60][87] - Management acknowledged the need for substantial additional funding in the near future to support ongoing operations and clinical trials [65] Other Important Information - The company has received two FDA Fast Track designations for LP-184 in glioblastoma and triple-negative breast cancer, which could expedite clinical development timelines [18] - The RADR platform has expanded beyond $100 billion in oncology-specific data points, enabling sophisticated analysis and biomarker discovery initiatives [56][58] Q&A Session Summary Question: How is the pace and quality of enrollment in Asia compared to the U.S.? - The enrollment pace in Asia is about 2x to 4x faster than in the U.S., with significant output observed in recent months [90] Question: What are the opportunities for ADCs that substitute the toxic payload with another immunotherapy? - The design of multi-payload ADCs is seen as a future direction, with potential for combining immunomodulating agents with toxic payloads [91][92] Question: What should be expected from the HARMONIC update later this year? - The company expects to have a significant amount of data from enrolled patients, with key insights anticipated by mid to late Q2 [96][100] Question: When will results for LP-184 be provided? - The results for LP-184 have been delayed due to higher dose levels being reached, with therapeutic levels of efficacy beginning to be observed [107] Question: When will the pediatric trial for STAR begin? - The company is close to finalizing a protocol for pediatric brain cancers and expects to launch the trial mid to late this year [111]

Financial Data and Key Metrics Changes - The company reported a net loss of approximately $5.9 million for Q4 2024, compared to a net loss of approximately $4.2 million in Q4 2023, reflecting an increase in loss per share from $0.39 to $0.54 [62] - For the full year 2024, R&D expenses were approximately $16.1 million, up from approximately $11.9 million in 2023, primarily due to increased research studies and payroll expenses [63] - The total cash position as of December 31, 2024, was approximately $24 million, which is expected to fund operations for at least 12 months [65] Business Line Data and Key Metrics Changes - All clinical stage drug candidates are now in Phase 1 and Phase 2 trials, with significant progress reported in the clinical pipeline and AI platform [12][14] - The Phase 2 asset LP-300 has seen accelerated enrollment, particularly in Japan and Taiwan, where the incidence of non-small cell lung cancer among never smokers is significantly higher [17][70] - The lead cohort for LP-300 achieved an 86% clinical benefit rate and a 43% objective response rate in never smoker non-small cell lung cancer patients [15] Market Data and Key Metrics Changes - The market potential for LP-300 is estimated to be between $4 billion to $5 billion annually, with a growing opportunity due to the increasing incidence of non-small cell lung cancer in specific populations [14] - The market potential across indications for LP-184 exceeds $10 billion annually, addressing over 150,000 patients with limited therapeutic options [20] Company Strategy and Development Direction - The company is focused on leveraging AI and machine learning to transform oncology drug discovery and development, aiming for significant returns for investors and patients [8] - The strategic expansion into Asia is expected to enhance enrollment rates and generate robust data sets, positioning the company for compelling readouts in 2025 [17][70] - The company is developing an agentic AI platform that will enhance drug development efficiency and precision, potentially reducing preclinical development costs by 60% to 80% [80] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the transformative potential of AI in oncology, emphasizing the importance of data-driven approaches in drug development [87] - The company anticipates multiple value-creating milestones throughout the year, with a focus on delivering transformative therapies for patients with limited treatment options [60] Other Important Information - The company has received two FDA Fast Track designations for LP-184 in glioblastoma and triple negative breast cancer, which could expedite clinical development timelines [18] - The RADR platform has expanded beyond $100 billion oncology-specific data points, enabling sophisticated analysis that traditional approaches cannot match [56] Q&A Session Summary Question: How is the pace and quality of enrollment in Asia compared to the U.S.? - The pace of enrollment in Asia is about 2x to 4x faster than in the U.S., with significant output observed in recent months [90] Question: What are the opportunities for ADCs that substitute the toxic payload with another immunotherapy? - The company sees potential in using small molecule immunomodulating agents in ADCs, and there is ongoing exploration of multi-payload designs [91][92] Question: What should be expected in the upcoming HARMONIC update? - The company expects to have a significant amount of data from enrolled patients, with key readouts anticipated in mid to late Q2 [100] Question: What is the status of LP-184 data? - The LP-184 data was delayed due to higher dose levels being reached, which has extended the timeline for results [107] Question: When will pediatric trials for STAR begin? - The company is close to finalizing a protocol for pediatric brain cancers and expects to launch trials mid to late this year [111]

Company Overview - Lantern Pharma is leveraging its AI platform, RADR®, to transform cancer drug discovery and development, aiming to reduce costs and accelerate timelines[5, 6] - The company has raised approximately $100 million in total capital since 2019[5] - RADR® can predict and stratify real-world patients for clinical trials with 88% accuracy[6] - Lantern has 12 disclosed and collaborative lead drug programs[11] Drug Development Programs - LP-300, targeting Non-Small Cell Lung Cancer (NSCLC) in never smokers, represents a $4+ billion global annual market potential and is currently in Phase 2 clinical trials[23, 24] - Initial Phase 2 trial data for LP-300 showed an 86% clinical benefit rate in the safety lead-in cohort[38, 43] - LP-184, targeting advanced solid tumors with DDR deficiencies, has a $14+ billion annual US market potential and is in Phase 1 clinical trials[54, 55] - LP-284, targeting B-cell Non-Hodgkin's Lymphomas (NHL), represents a $4 billion annual global market potential and is also in Phase 1 clinical trials[88, 89] AI Platform and Collaborations - Lantern's RADR® platform incorporates over 100 billion data points from 130K+ patient records and advanced ML algorithms[13] - The company has strategic collaborations with academic, research institutions, and biopharma companies to accelerate timelines and gain unique real-world insights[19, 20, 21]

Oncology Drug Candidates - The company has three lead clinical-stage oncology drug candidates: LP-300, LP-184, and LP-284, targeting multiple cancer indications including solid tumors and blood cancers [23]. - LP-300 is currently in a Phase 2 clinical trial (Harmonic™ trial) for never-smoking patients with NSCLC in combination with chemotherapy [28][42]. - LP-184, now referred to as STAR-001 for CNS indications, is advancing in a Phase 1A clinical trial and has shown promising activity against glioblastoma and other CNS cancers [27][42]. - LP-284 is also in a Phase 1A clinical trial, demonstrating promising in-vitro and in-vivo anticancer activity in multiple hematological cancers [28][42]. RADR Platform - The RADR platform consists of over 100 billion data points, integrating various data types to identify genomic signatures correlated to drug response, aiming to reduce the time and cost of drug development [22][25]. - The RADR platform has powered the development of new drug candidates and the advancement of new indications for existing drugs, covering over 135 cancer subtypes [43]. - The RADR platform has analyzed over 100 billion oncology-specific clinical and preclinical data points, covering more than 135 cancer subtypes and over 130,000 patient records [63]. - The RADR platform achieved an average historical accuracy of over 80% in distinguishing responders from non-responders in a population of 10 case studies [64]. - The RADR platform is designed to reduce the development timeline and costs associated with oncology drug development by validating predictive biomarkers [51]. - The RADR platform's workflow reduces approximately 18,000 features to about 200 significant genes, ultimately generating a targeted set of less than 50 candidate biomarkers [58]. - The RADR platform integrates biological knowledge and data-driven feature selection to generate hypothesis-free biomarker signatures, aiding in drug development [60]. - The RADR platform is being utilized to identify biomarkers that may correlate with heightened sensitivity to LP-300, potentially guiding patient selection for clinical trials [123]. Clinical Trials and Efficacy - The ongoing HARMONIC™ Study aims to enroll approximately 90 patients, focusing on never smokers with relapsed advanced primary adenocarcinoma of the lung [81]. - LP-300 demonstrated a 13.6 month improvement in overall survival for female never smokers compared to placebo, with a p-value of 0.0167 and a hazard ratio of 0.367 [78]. - The Phase 3 NSCLC adenocarcinoma trial showed an overall survival of 25.0 months for females receiving LP-300, with a 2-year survival rate of 51.4% [83]. - LP-300 has been administered to over 1,000 subjects in clinical trials and has been generally well-tolerated [78]. - The Phase 3 trial indicated that LP-300 could protect against chemotherapy-induced kidney toxicity and anemia, conditions that disproportionately affect females [83]. - The Phase 3 trial did not meet overall survival endpoints for all patients, but showed significant benefits for never smokers, especially females [84]. - For never-smoking women with adenocarcinoma, the overall survival in the LP-300 arm was 27.0 months versus 13.4 months in the control arm, indicating a statistically significant benefit [106]. Market Opportunity and Drug Development - The overall estimated Phase 1-to-approval probability of success for oncology drug development is just 3.3%, with an estimated mean cost of $4.4 billion to deliver a new oncology medicine [45]. - Biopharma AI spending is projected to reach $3 billion by 2025, driven by the shift towards AI-enhanced drug discovery and development [47]. - The company plans to expand its pipeline by identifying new drug candidates that have been abandoned or failed in late-stage clinical trials [74]. - The market opportunity for LP-300 is substantial, as it targets a growing indication of never-smokers with NSCLC, particularly among women [101]. - Approximately 226,650 new cases of lung cancer are expected in the US in 2023, with 110,680 in men and 115,970 in women [93]. - The incidence of non-small cell lung cancer (NSCLC) is estimated to be 192,653 in the US for 2025, accounting for approximately 85% of all lung cancer cases [96]. Drug Mechanism and Safety - LP-300 may enhance antitumor activity by modulating key signaling pathways and enzymes critical for DNA synthesis and repair [117]. - LP-300 inhibits human ALK and MET kinase activities, which are important in NSCLC adenocarcinoma [118]. - Treatment-related adverse events included fatigue (22% to 82%) and nausea (12% to 67%) in patients receiving LP-300 [109]. - Serious adverse events (SAEs) occurred in 11% to 49% of patients receiving LP-300, compared to 7% to 42% in control groups [112]. - LP-300's metabolites may protect against severe forms of chemotherapy-induced toxicities, including hearing loss and dehydration [110]. Future Studies and Collaborations - Future studies for LP-184 include a Phase 1b/2 dose expansion study in advanced triple-negative breast cancer and other solid tumors, focusing on safety and preliminary efficacy [135]. - The company plans to evaluate LP-184 in combination with olaparib for advanced HR-negative and HER2-negative breast cancer, aiming to determine optimal dosing regimens [136]. - A potential study of LP-184 in combination with nivolumab and ipilimumab for specific non-small cell lung cancer mutations is also planned, focusing on safety and clinical activity [137]. - The company is collaborating with the Danish Cancer Society Research Center to explore LP-100's clinical potential across nine solid tumor types with known DNA repair deficiencies [209]. Orphan Drug Designation - LP-184 has received Orphan Drug Designation from the FDA for pancreatic cancer, glioblastoma, and ATRT, indicating its potential in addressing significant unmet medical needs [128]. - LP-284 has received Orphan Drug Designation from the FDA for mantle cell lymphoma and high-grade B-cell lymphoma, indicating its potential in treating these aggressive cancers [182]. - STAR-001 has been granted Orphan Drug Designation for glioblastoma and other malignant gliomas by the FDA [141].

Clinical Trials and Drug Development - The HARMONIC™ trial for LP-300 achieved an 86% clinical benefit rate and a 43% objective response rate in never-smoker NSCLC patients, with enrollment accelerating in Japan and Taiwan[2] - LP-184 received two U.S. FDA Fast Track Designations in 2024 for Glioblastoma and Triple Negative Breast Cancer, along with three Rare Pediatric Disease Designations, indicating a multi-billion U.S. dollar market potential[2] - The company expects to have meaningful clinical readouts from its Phase 1 and Phase 2 programs in 2025, leveraging AI to transform oncology drug development[4] - LP-284 is currently in a Phase 1A trial for relapsed/refractory non-Hodgkin's lymphoma and solid tumors, with no dose-limiting toxicities observed through cohort 4[13] - The company plans to initiate a Phase 1b/2 study for LP-184 in TNBC, evaluating a combination regimen with the PARP inhibitor, Olaparib[11] Financial Performance - As of December 31, 2024, the company reported approximately $24 million in cash, cash equivalents, and marketable securities, down from approximately $41.3 million a year earlier[22] - Research and development expenses for Q4 2024 were approximately $4.3 million, compared to $3.6 million in Q4 2023, indicating a year-over-year increase[22] - The net loss for Q4 2024 was approximately $5.9 million (or $0.54 per share), compared to a net loss of approximately $4.2 million (or $0.39 per share) for Q4 2023[22] Artificial Intelligence and Data Utilization - The RADR® AI platform surpassed 100 billion oncology-specific data points in 2024, enhancing precision drug development initiatives[2] - Lantern Pharma is focused on leveraging its RADR platform to identify drug candidates and patient populations likely to respond to treatments[24] - The company aims to utilize artificial intelligence and machine learning to enhance the oncology drug discovery process, potentially reducing costs and risks[24] - Lantern's AI-driven pipeline of innovative product candidates is estimated to have a combined annual market potential of over $15 billion USD[23] Strategic Plans and Risks - Lantern Pharma has not yet received FDA marketing approval for any of its product candidates, which poses a significant risk to its future operations[24] - The company emphasizes the importance of securing sufficient future funding to support its clinical trials and operations[24] - Lantern Pharma's forward-looking statements are subject to various risks and uncertainties that could materially affect actual results[24] - The company plans to advance its drug candidates and maximize their commercial potential through internal development and collaborations[24] - Lantern Pharma's strategic plans include advancing its antibody drug conjugate (ADC) development program[24] - The company cautions investors against placing undue reliance on forward-looking statements due to inherent uncertainties[24] Research and Development Efforts - The company is actively engaged in research and development efforts for its internal drug discovery programs[24] - Lantern Pharma's disclosures regarding material information are disseminated through multiple channels, including its website and SEC filings[25]

Second Quarter 2024 Operating & Financial Results Conference Call / Webinar NASDAQ :LTRN With additional focus on preliminary patient data and clinical readouts for Phase 2 LP-300 Harmonic Trial August 8th, 2024 4:30 PM Eastern Time 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 ...

Financial Performance - The company reported net losses of approximately $10.4 million for the six months ended June 30, 2024, compared to $8.6 million for the same period in 2023, reflecting an increase in operating expenses [80]. - The total operating expenses for the six months ended June 30, 2024, were approximately $11.14 million, compared to $9.48 million for the same period in 2023, reflecting increased investment in clinical development [85]. - Net cash used in operating activities was approximately $8,259,000 for the six months ended June 30, 2024, compared to approximately $7,349,000 for the same period in 2023, indicating an increase in cash outflow [93]. - The company expects to incur significant and increasing operating losses for at least the next several years as it continues clinical trials and seeks regulatory approvals for its drug candidates [97]. - The company anticipates needing substantial additional funding to complete its clinical trials, which may lead to dilution of existing stockholders' interests [99]. Research and Development - Research and development expenses totaled $3.89 million for the three months ended June 30, 2024, compared to $3.56 million for the same period in 2023, indicating a continued investment in drug development [82]. - Research and development expenses increased by approximately $2,028,000, or 33%, from approximately $6,111,000 for the six months ended June 30, 2023, to approximately $8,140,000 for the six months ended June 30, 2024 [91]. - The company has three lead drug candidates (LP-300, LP-184, and LP-284) currently in clinical phases, with LP-300 undergoing a targeted phase 2 trial for advanced non-small cell lung cancer [76]. - The ADC program is advancing with a research collaboration with Bielefeld University in Germany, focusing on developing ADCs utilizing cryptophycin, which has shown promising antitumor activity [77]. - The company formed a wholly-owned subsidiary, Starlight Therapeutics, in January 2023 to focus on the clinical development of LP-184 for CNS and brain cancer indications [75]. - LP-100, another drug candidate, is being positioned for development in earlier lines of therapy after previously failing pivotal Phase 3 trials due to lack of biomarker-driven patient stratification [78]. Expenses and Cash Management - General and administrative expenses decreased by approximately $112,000, or 7%, from $1.63 million in Q2 2023 to $1.52 million in Q2 2024, primarily due to reductions in payroll and insurance expenses [86]. - General and administrative expenses decreased by approximately $364,000, or 11%, from approximately $3,365,000 for the six months ended June 30, 2023, to approximately $3,001,000 for the six months ended June 30, 2024 [90]. - Net cash used in investing activities decreased from approximately $1,418,000 for the six months ended June 30, 2023, to approximately $758,000 for the six months ended June 30, 2024 [94]. - As of June 30, 2024, total assets were approximately $35.6 million, with liquidity including approximately $33.3 million of cash, cash equivalents, and marketable securities [97]. - Lantern Pharma's cash and cash equivalents consist primarily of cash and money market funds, limiting exposure to market risk from interest rate changes [102]. Currency and Inflation - Foreign currency losses of approximately $51,000 were experienced for each of the six months ended June 30, 2024, and 2023, related to the Australian subsidiary [103]. - The company does not expect inflation to have a material effect on its results of operations during the periods presented, although it acknowledges potential future impacts [103]. - Inflation has not had a material effect on the company's results of operations during the periods presented, but could impact future results if it remains high [103]. - The company considers the risk of foreign currency losses to be manageable and not expected to be material in the future [103]. - The company does not participate in foreign currency hedging activities and does not have other derivative financial instruments [103]. Governance and Compliance - Management evaluated the effectiveness of disclosure controls and procedures as of June 30, 2024, concluding they are effective [106]. - There were no changes in internal control over financial reporting that materially affected the company during the three months ended June 30, 2024 [107]. - Lantern Pharma had no long-term debt outstanding as of June 30, 2024, and December 31, 2023 [101]. - The company maintains significant amounts of cash and cash equivalents at financial institutions that exceed federally insured limits [102]. - Lantern Pharma raised capital historically through the issuance of equity securities [101].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Lantern Pharma Inc. (Exact name of registrant as specified in its charter) | Delaware | 001-39318 | 46-3973463 | | --- | --- | --- | | (State or Other Jurisdiction | (Commission | (IRS Empl ...

[Introduction & Q1 2024 Business Highlights](index=1&type=section&id=Introduction%20%26%20Q1%202024%20Business%20Highlights) Lantern Pharma made significant progress in Q1 2024 across clinical trials, AI platform development, and strategic collaborations [CEO Statement](index=1&type=section&id=CEO%20Statement) CEO Panna Sharma highlighted significant Q1 2024 progress in clinical trials and AI platform, emphasizing AI's role in transforming biopharma development and fostering collaborations - Lantern Pharma made meaningful progress across multiple clinical trials and in furthering its AI platform, advancing internal capabilities to support data-driven, precision oncology trials and accelerate cost-effective development of drug-conjugates[2](index=2&type=chunk) - The company is at the forefront of demonstrating how combining emerging AI technologies, cancer biology, biomarker expertise, and focused clinical operations can transform timelines and costs in biopharma development[2](index=2&type=chunk) - Growing interest in machine-learning enabled drug development and the RADR AI platform is energizing the team, with excitement for increased collaborations and streamlined development of high-value drug candidates[5](index=5&type=chunk) [Key Business Highlights](index=1&type=section&id=Key%20Business%20Highlights) Q1 2024 featured active clinical trials for three AI-guided drug candidates, regulatory approvals, and advancement of LP-184 and LP-284, alongside subsidiary and AI module progress, and **$38.4 million** in cash - Active clinical trials are underway for three AI-guided drug candidates, with initial data and clinical readouts for LP-184 on-track for the second half of 2024[3](index=3&type=chunk) - Regulatory allowance was obtained to begin Phase 2 Harmonic™ clinical trial enrollment in Japan and Taiwan, targeting never-smokers with NSCLC, while enrollment continues in the US[3](index=3&type=chunk) - Phase 1 clinical trials for LP-184 and LP-284 are advancing with no dose-limiting toxicities observed in any patient cohorts to date[3](index=3&type=chunk) - Starlight Therapeutics, a wholly-owned subsidiary, advanced with the filing of a clinical trial protocol for the Phase 1B dose optimization and expansion cohort in recurrent IDH wild-type high-grade gliomas[3](index=3&type=chunk) - An AI-powered module for streamlining and guiding differentiated ADC development was advanced, expected to be instrumental for next-generation drug candidates[3](index=3&type=chunk) - An AI-driven collaboration was established with Oregon Therapeutics to leverage the RADR platform for future clinical development strategies of a novel cancer metabolism inhibitor[3](index=3&type=chunk) Key Financial Metric (Q1 2024) | Metric | Value (as of March 31, 2024) | | :---------------------------------------- | :--------------------------- | | Cash, cash equivalents, and marketable securities | ~$38.4 million | [AI-Powered Pipeline Updates](index=2&type=section&id=AI-Powered%20Pipeline%20Updates) The company advanced its key AI-guided drug candidates, LP-184, LP-300, and LP-284, through various clinical trial stages and regulatory approvals [LP-184 Clinical Development](index=2&type=section&id=LP-184%20Clinical%20Development) LP-184's Phase 1A trial advanced with five dosed cohorts and no dose-limiting toxicities, targeting DDR deficient tumors, with data readout expected soon and diagnostic test development underway - Five cohorts of patients (dose levels 1-5) have been enrolled and dosed in the ongoing Phase 1A clinical trial for LP-184, with no observed dose-limiting toxicities to date[6](index=6&type=chunk) - Enrollment for LP-184's Phase 1A trial is expected to be complete this summer, with data readout anticipated in late summer or early fall[6](index=6&type=chunk) - Efforts are focused on enrolling cancer patients with DDR (DNA damage repair) deficient tumors, as these have shown higher sensitivity to LP-184[6](index=6&type=chunk) - Dose optimization and expansion protocols (Supplement A and B) have been submitted to the FDA for LP-184 in non-CNS solid tumors (including TNBC with DDR alterations) and recurrent IDH wild-type high-grade gliomas (in collaboration with Starlight Therapeutics)[6](index=6&type=chunk) - Development of a PCR-based molecular diagnostic test has been initiated to identify cancer patients most likely to respond to LP-184 treatment[7](index=7&type=chunk) LP-184 Estimated Annual Global Market Potential | Indication | Estimated Annual Market Potential | | :----------- | :-------------------------------- | | CNS cancers | $4.5+ billion | | Solid tumors | $7.5+ billion | | **Total** | **$12+ billion** | [LP-300 Clinical Development (Harmonic™ Trial)](index=3&type=section&id=LP-300%20Clinical%20Development%20(Harmonic%E2%84%A2%20Trial)) The Phase 2 Harmonic™ trial for LP-300 is actively enrolling in the US and received regulatory approval in Japan and Taiwan, aiming to accelerate data and foster Asian partnerships - The Harmonic™ trial is assessing LP-300 in combination with standard-of-care chemotherapy (carboplatin and pemetrexed) for LCINS (Lung Cancer In Never Smokers) patients with relapsed NSCLC[11](index=11&type=chunk) - Phase 2 Harmonic™ clinical trial sites in the US are continuing to screen and increase patient enrollment, with approval also received to proceed in Japan and Taiwan[12](index=12&type=chunk) - In Japan and Taiwan, one-third of all lung cancer diagnoses are made among never-smokers, improving LP-300's positioning for collaborative and co-development partnerships in Asian markets[10](index=10&type=chunk)[12](index=12&type=chunk) LP-300 Estimated Annual Market Potential | Region | Estimated Annual Market Potential | | :----- | :-------------------------------- | | US | $1.5 billion | | Global | Over $2.6 billion | [LP-284 Clinical Development](index=3&type=section&id=LP-284%20Clinical%20Development) LP-284's Phase 1a trial dosed initial cohorts without dose-limiting toxicities, with plans for Q2 site expansion and advancement to Phase 1b/2 by year-end, targeting DDR-deficient lymphomas and sarcomas - The initial two cohorts of patients have been dosed in LP-284's Phase 1a clinical trial, with no dose-limiting toxicities observed[12](index=12&type=chunk) - Lantern Pharma expects to open additional US sites for LP-284 throughout Q2 2024, with potential to advance to Phase 1b/2 by the close of 2024[12](index=12&type=chunk) - LP-284 has demonstrated nanomolar potency in preclinical studies across various NHL cancer subtypes (MCL, DHL) and certain sarcomas with DDR deficiencies, particularly those with compromised ATM gene function[12](index=12&type=chunk) - There is an urgent and unmet need for novel therapeutic options for MCL, DHL, and HGBL patients, nearly all of whom relapse from current standard-of-care agents[12](index=12&type=chunk) LP-284 Estimated Annual Market Potential (US & Europe) | Indication | Estimated Annual Market Potential | | :-------------- | :-------------------------------- | | MCL, DHL, HGBLs | Over $3+ billion | [Platform & Subsidiary Development](index=4&type=section&id=Platform%20%26%20Subsidiary%20Development) The company advanced its core AI platform, its CNS-focused subsidiary, and novel drug conjugate programs, expanding capabilities and strategic partnerships [RADR® Platform Growth and Development](index=4&type=section&id=RADR%C2%AE%20Platform%20Growth%20and%20Development) The RADR® AI platform expanded its capabilities and data scope, securing a new collaboration with Oregon Therapeutics to optimize XCE853 development and planning further partnerships in 2024 - RADR® continues to advance in size, scope, and capabilities, progressing towards becoming a standard for AI-driven drug development in oncology for both early-stage development and later-stage patient biomarker and combination therapy identification[14](index=14&type=chunk) - An AI-driven collaboration was announced with Oregon Therapeutics to optimize the development of a protein disulfide isomerase (PDI) inhibitor drug candidate, XCE853, for various cancer indications[14](index=14&type=chunk) - The collaboration leverages RADR's AI-based capabilities, including over **200 machine learning algorithms**, to uncover biomarkers, molecular correlates of efficacy, and define potential combination regimens for XCE853[14](index=14&type=chunk) - Lantern Pharma will receive equal IP co-ownership and drug development rights for newly discovered biomarkers, novel indications, and new pharmacological strategies for XCE853[14](index=14&type=chunk) - The scope of RADR®'s data has broadened to include additional classes of compounds like ADCs, and detailed chemical/biochemical features and drug-interaction data, with plans for more biopharma and technology partnerships in 2024[14](index=14&type=chunk) [Starlight Therapeutics](index=4&type=section&id=Starlight%20Therapeutics) Starlight Therapeutics, focusing on CNS cancers, advanced STAR-001 with a Phase 1B protocol filing, hired a CMO, and anticipates Phase 1b/2 trials in H2 2024, targeting a **$4.5 billion to $5+ billion USD** market - Starlight Therapeutics, a wholly-owned subsidiary focused on CNS and brain cancers with STAR-001 (LP-184 for CNS indications), filed a clinical trial protocol for the Phase 1B dose optimization and expansion cohort in recurrent IDH wild-type high-grade gliomas[15](index=15&type=chunk) - Dr. Marc Chamberlain was hired as CMO in Q4 2023 to focus on Starlight's clinical trials, personnel development, and corporate development activity[17](index=17&type=chunk) - Starlight and Lantern expect to initiate Phase 1b/2 clinical trials for STAR-001 during the second half of 2024[17](index=17&type=chunk) STAR-001 Estimated Market Potential | Indication | Estimated Market Potential | | :------------------------------------------ | :------------------------- | | Adult and pediatric primary and secondary CNS cancers | $4.5 billion to $5+ billion USD | [ADC & Drug Conjugate Programs](index=5&type=section&id=ADC%20%26%20Drug%20Conjugate%20Programs) Lantern Pharma advanced its cryptophycin-based ADC program, showing picomolar potency and an **80% cancer cell kill rate** in preclinical studies, with IND development planned for 2024 and an AI module for ADC development progressing - Lantern, in collaboration with academic partners, advanced the development, synthesis, and preclinical proof-of-concept of a novel, highly potent, cryptophycin-based ADC (cpADC)[18](index=18&type=chunk) - The cpADC demonstrated picomolar potency in a wide range of solid tumors and produced an **80% cancer cell kill rate** in preclinical work, outperforming other approved ADCs, including in medium and low HER-2 expression cancers[18](index=18&type=chunk) - Lantern expects to move towards IND development of its ADC program during 2024, focusing on select solid tumors unresponsive or refractory to current therapies[18](index=18&type=chunk) - An AI module for differentiated, machine-learning based ADC development, characterization, analysis, and bioactivity prediction is being advanced as an extension to RADR®, leveraging its data and biomarker insights[18](index=18&type=chunk) [Additional Operational Highlights](index=5&type=section&id=Additional%20Operational%20Highlights) The company shared recent scientific findings through publications and presentations, and launched a new webinar series to engage with stakeholders [Publications and Presentations](index=5&type=section&id=Publications%20and%20Presentations) Lantern Pharma published new research on LP-184's lethal activity in HR deficient cancer cells and presented LP-284 clinical trial data at the AACR 2024 Annual Meeting - A new publication in Cancer Research Communications showcased LP-184's lethal activity, inducing elevated DNA double-strand breaks in HR deficient (HRD) cancer cells, with up to **12-fold increased sensitivity** observed with depletion of key HR components[19](index=19&type=chunk) - LP-184 demonstrated nanomolar potency in a diverse range of HRD cancer models[19](index=19&type=chunk) - New data and scientific findings for LP-284 and its ongoing clinical trial were presented at the American Association for Cancer Research (AACR) 2024 Annual Meeting[19](index=19&type=chunk) [Webinar Series Launch](index=6&type=section&id=Webinar%20Series%20Launch) Lantern Pharma launched 'Webinar Wednesdays,' an educational series providing updates on research, clinical trials, and AI efforts, with the first webinar focusing on LP-300 and the Harmonic trial - Lantern Pharma announced a new series of educational webinars titled 'Webinar Wednesdays' to provide updates on its research, clinical trials, and AI efforts[21](index=21&type=chunk) - The first webinar, held on April 24th, featured Dr. Joseph Treat discussing LP-300 and the Harmonic clinical trial focused on LCINS patients[21](index=21&type=chunk) [First Quarter 2024 Financial Highlights](index=6&type=section&id=First%20Quarter%202024%20Financial%20Highlights) The company reported its financial performance for Q1 2024, including changes in cash, operating expenses, net loss, and warrant exercises [Balance Sheet](index=6&type=section&id=Balance%20Sheet) Cash, cash equivalents, and marketable securities decreased to approximately **$38.4 million** as of March 31, 2024, reflecting a capital-efficient business model Cash, Cash Equivalents, and Marketable Securities | Metric | As of March 31, 2024 | As of December 31, 2023 | Change (QoQ) | | :---------------------------------------- | :------------------- | :---------------------- | :----------------- | | Cash, cash equivalents, and marketable securities | ~$38.4 million | ~$41.3 million | Down ~$2.9 million | - The quarterly cash burn rate continues to reflect Lantern Pharma's capital-efficient, collaborator-centered business model[22](index=22&type=chunk) [Operating Expenses](index=6&type=section&id=Operating%20Expenses) Research and development expenses increased to **$4.3 million** in Q1 2024 due to clinical trial activity, while general and administrative expenses slightly decreased to **$1.5 million** Operating Expenses (Q1 2024 vs. Q1 2023) | Expense Category | Q1 2024 | Q1 2023 | Change (YoY) | | :--------------- | :-------------- | :-------------- | :--------------- | | R&D Expenses | ~$4.3 million | ~$2.6 million | Up ~$1.7 million | | G&A Expenses | ~$1.5 million | ~$1.7 million | Down ~$0.2 million | - The increase in R&D expenses was largely driven by an increase in clinical trial activity and clinical trial site activations[23](index=23&type=chunk) [Net Loss](index=6&type=section&id=Net%20Loss) Net loss for Q1 2024 increased to approximately **$5.4 million**, or **$0.51 per share**, compared to **$3.9 million**, or **$0.36 per share**, in Q1 2023 Net Loss (Q1 2024 vs. Q1 2023) | Metric | Q1 2024 | Q1 2023 | Change (YoY) | | :--------------- | :-------------- | :-------------- | :--------------- | | Net Loss | ~$5.4 million | ~$3.9 million | Up ~$1.5 million | | Net Loss per Share | ~$0.51 | ~$0.36 | Up ~$0.15 | [Warrant Exercises](index=6&type=section&id=Warrant%20Exercises) In Q1 2024, Lantern issued **20,132 shares** from cashless warrant exercises and **17,481 shares** for cash, leaving **81,496 warrants** outstanding at a **$16.55** weighted average exercise price - Lantern issued **20,132 shares** of common stock in Q1 2024 from the cashless exercise of warrants to purchase **79,021 shares**[25](index=25&type=chunk) - An additional **17,481 shares** of common stock were issued in Q1 2024 for approximately **$55,000** from the exercise of warrants for cash[25](index=25&type=chunk) - Following these exercises, **81,496 warrants** remain outstanding to purchase Lantern common stock at a weighted average exercise price of **$16.55 per share**[25](index=25&type=chunk) [Company Information](index=7&type=section&id=Company%20Information) This section provides an overview of Lantern Pharma's mission, its AI platform, and its commitment to transparent communication with investors [About Lantern Pharma](index=7&type=section&id=About%20Lantern%20Pharma) Lantern Pharma, an AI company, leverages its RADR® platform with **60 billion+ oncology data points** to accelerate drug discovery, boasting a growing clinical pipeline and a **$15 billion+ USD** market potential - Lantern Pharma is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development[28](index=28&type=chunk) - Its proprietary AI and machine learning (ML) platform, RADR®, leverages over **60 billion oncology-focused data points** and a library of **200+ advanced ML algorithms**[28](index=28&type=chunk) - Newly developed drug programs have advanced from initial AI insights to first-in-human clinical trials in **2-3 years**, at approximately **$1.0 - 2.5 million** per program[28](index=28&type=chunk) - The company's lead development programs include a Phase 2 clinical program and multiple Phase 1 clinical trials[29](index=29&type=chunk) - Starlight Therapeutics, a wholly-owned subsidiary, focuses exclusively on the clinical execution of promising therapies for CNS and brain cancers[29](index=29&type=chunk) - The AI-driven pipeline of innovative product candidates is estimated to have a combined annual market potential of over **$15 billion USD**[29](index=29&type=chunk) [Forward-Looking Statements](index=8&type=section&id=Forward-Looking%20Statements) This section outlines forward-looking statements concerning future events, financial performance, and drug development risks, cautioning investors against undue reliance and disclaiming update obligations - The press release contains forward-looking statements concerning future events, financial performance, the potential of the RADR platform, strategic plans, clinical trial timing, market estimates, and the development of drug candidates[33](index=33&type=chunk) - Important factors could cause actual results to differ materially from forward-looking statements, including risks related to research success, preclinical observations, licensing, clinical testing, FDA approval, and the commercialization of RADR®-based products[33](index=33&type=chunk) - Investors are cautioned not to place undue reliance on these statements, and the company disclaims any obligation to update them, except as required by law[33](index=33&type=chunk) [Disclosure Channels](index=8&type=section&id=Disclosure%20Channels) Lantern Pharma disseminates material information through its website, press releases, SEC filings, and social media to ensure broad and non-exclusionary public distribution - Lantern Pharma disseminates material information to the public through its website, press releases, SEC filings, digital newsletters, and social media to achieve broad, non-exclusionary distribution[34](index=34&type=chunk) - Investors are encouraged to review information made public through these channels, as it could be deemed material[34](index=34&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Lantern Pharma Inc. (Exact name of registrant as specified in its charter) | Delaware | 001-39318 | 46-3973463 | | --- | --- | --- | | (State or Other Jurisdiction | (Commission | (IRS Employer ...