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 ...

Exhibit 99.1 Lantern Pharma Reports First Quarter 2024 Financial Results and Business Highlights Thursday, May 9, 2024 DALLAS — (Business Wire) — Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence ("AI") company developing targeted and transformative cancer therapies using its proprietary RADR AI and machine learning ("ML") platform with multiple clinical-stage drug programs, today announced operational highlights and financial results for the first quarter 2024, ended March 31, 2024. "Our compa ...

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 ...

Exhibit 99.1 Lantern Pharma Reports Fourth Quarter & Fiscal Year 2023 Financial Results and Business Highlights Monday, March 18, 2024 DALLAS—(Business Wire)—Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence ("AI") company developing targeted and transformative cancer therapies using its proprietary RADR AI and machine learning ("ML") platform with multiple clinical-stage drug programs, today announced operational highlights and financial results for the fourth quarter and fiscal year ended Dec ...

Lantern Pharma Inc. (NASDAQ:LTRN) Q3 2023 Earnings Conference Call November 8, 2023 4:30 PM ET Company Participants Panna Sharma - President and Chief Executive Officer David Margrave - Chief Financial Officer Conference Call Participants Operator Good afternoon, and welcome to our Third Quarter 2023 Earnings Call. As a reminder, this call is being recorded and all attendees are in a listen-only mode. We will open the call for questions and answers after our management’s presentation. A webcast replay of to ...