Financial Data and Key Metrics Changes - The company recorded a net loss of approximately $4,500,000 for Q1 2025, down from $5,400,000 in the same period last year, reflecting improved operational efficiency [21][24] - General and administrative expenses were approximately $1,510,000 for Q1 2025, compared to $1,480,000 in the prior year [23] - R&D expenses decreased to approximately $3,300,000 in Q1 2025 from $4,300,000 in Q1 2024, primarily due to reduced costs in CRO and clinical site expenses [23] Business Line Data and Key Metrics Changes - The clinical pipeline includes significant advancements, particularly with LP-184, which is in a Phase 1a trial with enrollment expected to complete by June 2025 [7][10] - The HARMONIC Phase 2 trial for LP-300 is progressing well, with a reported 86% clinical benefit rate and 43% objective response rate in the safety lead-in cohort [11] Market Data and Key Metrics Changes - The estimated annual market potential for LP-184's target indications is approximately $14,000,000,000, with $4,000,000,000 for CNS cancers and about $10,000,000,000 for other solid tumors [13] - The market opportunity for metastatic triple negative breast cancer (TNBC) is estimated to exceed $4,000,000,000 annually [10] Company Strategy and Development Direction - The company is focused on leveraging AI and machine learning to enhance drug discovery and development processes, aiming to transform precision oncology therapies [5][6] - Plans to commercialize the RADAR AI platform through a freemium model to foster collaborations and enhance data aggregation [15][39] Management's Comments on Operating Environment and Future Outlook - Management highlighted the importance of AI in drug development, emphasizing that the integration of agentic capabilities in the RADAR platform will drive significant advancements in therapeutic development [27][28] - The company is strategically positioned to maximize shareholder value through disciplined capital management and potential partnerships with biopharma companies [20][30] Other Important Information - The company ended the quarter with approximately $19,700,000 in cash, cash equivalents, and marketable securities, providing an expected operating runway through at least May 2026 [20][24] - The RADAR AI platform has expanded to approximately 200,000,000,000 oncology-focused data points, enhancing its capabilities for drug candidate optimization and biomarker development [13][14] Q&A Session Summary Question: Plans for commercializing AI modules - The company plans to start with a freemium model for the blood-brain barrier penetration module to encourage collaboration and data aggregation [37][39] Question: Clarification on the HARMONIC trial design - The expansion cohort will include both US and Asian patients, with a randomized design to ensure quality data [40][44] Question: Expectations for LP-184 trial enrollment - The trial is expected to be fully enrolled next month, with preliminary data anticipated shortly thereafter [48] Question: FDA's use of AI in evaluations - Management believes the FDA will increasingly utilize AI in its evaluations, which could improve efficiency and reduce costs [49][50] Question: Attracting new investors through AI initiatives - The company aims to attract new investors by opening up AI modules and demonstrating their precision and focus compared to existing tools [52]

Financial Data and Key Metrics Changes - The company recorded a net loss of approximately $4.5 million for Q1 2025, down from $5.4 million in the same period last year, reflecting improved operational efficiency [23][20] - General and administrative expenses were approximately $1.51 million, slightly up from $1.48 million year-over-year, while R&D expenses decreased to approximately $3.3 million from $4.3 million, primarily due to reduced costs in CRO and clinical site operations [22][23] - The cash position as of March 31, 2025, was approximately $19.7 million, providing an expected operating runway through at least May 2026 [23][20] Business Line Data and Key Metrics Changes - The clinical pipeline is advancing with the Phase 1a trial for LP-184 progressing well, with enrollment expected to complete by June 2025 [7][9] - The HARMONIC Phase 2 trial for LP-300 is making strong progress, particularly in Japan and Taiwan, with an 86% clinical benefit rate and a 43% objective response rate reported [11][12] - The RADAR AI platform has expanded to approximately 200 billion oncology-focused data points, enhancing its capabilities for drug candidate optimization and biomarker development [13][14] Market Data and Key Metrics Changes - The market potential for LP-184 in metastatic triple-negative breast cancer (TNBC) is estimated to exceed $4 billion annually, while the potential for drug-resistant non-small cell lung cancer is over $2 billion [10][12] - The global annual market potential for LP-184's target indications is estimated at about $14 billion, with significant opportunities in CNS cancers and other solid tumors [13] Company Strategy and Development Direction - The company is focused on leveraging AI and machine learning to transform drug development processes, aiming to create significant returns for investors and patients [5][6] - The strategy includes advancing clinical programs while expanding the AI platform capabilities, with plans to commercialize RADAR AI modules to foster collaborations [16][29] - The company is entering discussions with potential biopharma partners for licensing agreements and co-development opportunities [20][29] Management's Comments on Operating Environment and Future Outlook - Management highlighted the importance of AI in drug discovery and development, indicating that the integration of agentic AI capabilities will enhance the RADAR platform's effectiveness [26][30] - The company is optimistic about completing enrollment for LP-184's trial and expects to deliver comprehensive data readouts that could establish proof of mechanism [28] - Management anticipates that the FDA will increasingly utilize AI in evaluating scientific literature and data, which could improve efficiency in the regulatory process [50] Other Important Information - The company has maintained fiscal discipline, with no capital raises since January 2021, allowing it to fund clinical trials effectively [20] - The RADAR AI platform's blood-brain barrier penetration prediction tool is expected to be one of the first modules made publicly available, enhancing CNS drug discovery [15][16] Q&A Session Summary Question: Plans for commercializing AI modules - The company plans to start with a freemium model for the blood-brain barrier penetration module to encourage collaboration and data aggregation [34][36] Question: Clarification on the HARMONIC trial design - The expansion cohort for the HARMONIC trial will include both US and Asian patients, with a randomized design to ensure quality data [38][41] Question: Expectations for LP-184 trial enrollment - The trial for LP-184 is expected to be fully enrolled next month, with preliminary data anticipated shortly thereafter [48] Question: FDA's use of AI in evaluations - Management believes the FDA will increasingly adopt AI in its evaluations, which could lead to improved efficiency and reduced costs in the regulatory process [50]

Clinical Development - LP-184 Phase 1a clinical trial is expected to be completed by the end of June 2025 with 62-65 patients enrolled across a range of solid tumors[9] - Additional patient data readout from the HARMONIC™ Trial evaluating LP-300 in never-smokers with non-small cell lung cancer is anticipated in Q3 2025, including initial readout for patients from the Asian expansion cohort[9] - Independent preclinical confirmation of LP-184 hypersensitivity in rare pediatric brain tumors, such as ATRT, by collaborators at Johns Hopkins supports a planned pediatric trial in CNS tumors[12] RADR® AI Platform - The company strengthened its AI intellectual property portfolio with PCT publication of a proprietary blood-brain barrier penetration prediction patent application[9] - The RADR® platform was expanded with an innovative AI-powered module to improve the precision, cost, and timeline of antibody-drug conjugate (ADC) development[9] - The company is planning commercial availability and launch of select RADR® AI modules for the scientific and research community to foster collaborative, open-source innovation in cancer drug development[12] Financial Status - As of March 31, 2025, the company maintained disciplined capital management, with approximately $19.7 million in cash, cash equivalents, and marketable securities, providing an expected operating runway through at least May 15, 2026[12] - Total operating expenses for the three months ended March 31, 2025 were $4,774,032, compared to $5,732,001 for the same period in 2024[14] - Net loss for the three months ended March 31, 2025 was $4,536,783, or $0.42 per common share, compared to a net loss of $5,440,810, or $0.51 per common share, for the same period in 2024[14]

[Forward-Looking Statements](index=3&type=section&id=Forward%20Looking%20Statements) The report contains forward-looking statements regarding strategy and operations, which are subject to significant risks and uncertainties - This report contains forward-looking statements concerning the company's strategy, future clinical and research activities, financial position, and management objectives[7](index=7&type=chunk) - Key forward-looking statements cover the RADR® A.I. platform's potential, drug candidate advancement, clinical trial timelines, and future funding needs[8](index=8&type=chunk) - The company cautions against undue reliance on these statements, as actual results may differ materially due to factors in the 2024 Form 10-K[9](index=9&type=chunk)[10](index=10&type=chunk) [PART I – FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) [Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements.) For Q1 2025, the company reported a net loss of $4.54 million and a decrease in total assets to $21.1 million, reflecting ongoing R&D investment without revenue [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Total assets decreased to $21.1 million as of March 31, 2025, driven by a reduction in cash and marketable securities Condensed Consolidated Balance Sheet Highlights (Unaudited) | Balance Sheet Item | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $6,377,602 | $7,511,079 | | Marketable securities | $13,344,049 | $16,501,984 | | **Total Assets** | **$21,096,335** | **$25,571,792** | | **Total Liabilities** | **$4,319,850** | **$4,384,018** | | **Total Stockholders' Equity** | **$16,776,485** | **$21,187,774** | [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company's Q1 2025 net loss improved to $4.54 million from $5.44 million year-over-year, primarily due to lower R&D expenses Condensed Consolidated Statements of Operations (Unaudited) | Line Item | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | General and administrative | $1,510,077 | $1,481,215 | | Research and development | $3,263,955 | $4,250,786 | | Loss from operations | ($4,774,032) | ($5,732,001) | | **Net Loss** | **($4,536,783)** | **($5,440,810)** | | **Net loss per share, basic and diluted** | **($0.42)** | **($0.51)** | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $4.38 million in Q1 2025, with a net decrease in cash of $1.13 million Cash Flow Summary (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | ($4,375,610) | ($3,068,523) | | Net cash provided by (used in) investing activities | $3,239,331 | ($556,168) | | Net cash provided by financing activities | $0 | $54,716 | | **Change in Cash and Cash Equivalents** | **($1,133,477)** | **($3,579,805)** | [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) Notes detail the company's A.I.-driven oncology focus, funding sufficiency for 12 months, and key accounting policies and commitments - The company is an A.I.-focused firm developing cancer therapies with **three clinical-stage product candidates**: LP-300, LP-184, and LP-284, and an Antibody Drug Conjugate (ADC) program[27](index=27&type=chunk)[30](index=30&type=chunk) - Existing cash, cash equivalents, and marketable securities of approximately **$19.7 million** as of March 31, 2025, will be sufficient to fund operations for at least the next 12 months[34](index=34&type=chunk) - Expenses for License, Strategic Alliance, and Research Agreements totaled approximately **$1.18 million** for the three months ended March 31, 2025, a decrease from $2.10 million in the same period of 2024[55](index=55&type=chunk) - As of March 31, 2025, the company has **70,000 warrants outstanding** and exercisable to purchase common stock at a weighted-average exercise price of $18.75 per share, which expire on June 10, 2025[66](index=66&type=chunk) [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management discusses its A.I.-driven drug development strategy, a 23% decrease in Q1 2025 R&D expenses, and capital sufficiency for the next 12 months - The company's strategy is to use its proprietary A.I. platform, RADR®, which has nearly **200 billion data points**, to identify and develop new and 'rescued' oncology drug candidates, aiming to reduce development time and cost[81](index=81&type=chunk)[83](index=83&type=chunk) - The clinical portfolio includes **LP-300 (Phase 2 for NSCLC)**, **LP-184 (Phase 1A for solid tumors)**, and **LP-284 (Phase 1A for hematological cancers)**[82](index=82&type=chunk)[86](index=86&type=chunk) - The company believes its existing cash, cash equivalents, and marketable securities will fund operating expenses and capital requirements for **at least 12 months** from the filing date of this Form 10-Q[107](index=107&type=chunk) [Results of Operations](index=23&type=section&id=Results%20of%20Operations) R&D expenses decreased by 23% to $3.26 million in Q1 2025 compared to Q1 2024, driven by lower costs for the LP-184 program Research and Development Expenses by Project (Unaudited) | Project | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | LP-300 | $1,007,908 | $1,051,904 | | LP-184 | $1,361,464 | $2,232,602 | | LP-284 | $456,471 | $462,423 | | **Total R&D Expenses** | **$3,263,955** | **$4,250,786** | - The **23% decrease in R&D expenses** was primarily driven by a $963,000 reduction in research services, mainly from lower CRO and clinical site costs for LP-184[100](index=100&type=chunk) - General and administrative expenses **increased by 2%** due to higher professional fees and salaries, partially offset by a decrease in business development expenses[99](index=99&type=chunk) [Liquidity and Capital Resources](index=25&type=section&id=Liquidity%20and%20Capital%20Resources) The company holds $16.5 million in working capital, sufficient for 12 months, but anticipates needing substantial future funding for clinical trials - The company has working capital of approximately **$16,537,000** as of March 31, 2025, and believes it can fund operations for at least the next 12 months[107](index=107&type=chunk) - Net cash used in operating activities increased in Q1 2025 compared to Q1 2024, mainly due to less favorable changes in accounts payable and prepaid expenses in the current period[104](index=104&type=chunk) - The company expects to incur increasing operating losses and will need to obtain **substantial additional funding**, potentially through equity or debt financing, which could dilute existing stockholders[108](index=108&type=chunk)[110](index=110&type=chunk) [Quantitative and Qualitative Disclosures About Market Risk](index=26&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) As a Smaller Reporting Company, the company is exempt from this item but notes minor interest rate and foreign currency risks - As a **Smaller Reporting Company**, Lantern Pharma is exempt from the requirements of Item 3[118](index=118&type=chunk) - The company's primary market risk is **interest rate sensitivity** on its marketable securities and has minor foreign currency risk from its Australian subsidiary but does not engage in hedging[112](index=112&type=chunk)[116](index=116&type=chunk) [Controls and Procedures](index=27&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management concluded that disclosure controls and procedures were effective as of March 31, 2025, with no material changes to internal controls - Based on an evaluation as of March 31, 2025, the CEO and CFO concluded that the company's disclosure controls and procedures were **effective** at the reasonable assurance level[120](index=120&type=chunk) - **No changes occurred** in the company's internal control over financial reporting during the quarter ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, internal controls[121](index=121&type=chunk) [PART II – OTHER INFORMATION](index=29&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) [Risk Factors](index=29&type=section&id=Item%201A.%20Risk%20Factors.) The company is exempt from the requirements of this item as it qualifies as a Smaller Reporting Company - As a **Smaller Reporting Company**, Lantern Pharma is exempt from the requirements of Item 1A[125](index=125&type=chunk) [Exhibits](index=29&type=section&id=Item%206.%20Exhibits.) This section lists filed exhibits, including Sarbanes-Oxley certifications and Inline XBRL documents - The exhibits filed include **CEO and CFO certifications** pursuant to Sarbanes-Oxley Sections 302 and 906, along with various Inline XBRL files[126](index=126&type=chunk) [Signatures](index=30&type=section&id=Signatures) The report was duly signed and authorized by the CEO and CFO on May 15, 2025 - The report was duly signed and authorized on May 15, 2025, by **Panna Sharma, Chief Executive Officer**, and **David R. Margrave, Chief Financial Officer**[128](index=128&type=chunk)[129](index=129&type=chunk)

[Lantern Pharma Q1 2025 Financial Results and Business Updates](index=1&type=section&id=Lantern%20Pharma%20Reports%20First%20Quarter%202025%20Financial%20Results%20and%20Business%20Updates) [Business & Operational Highlights](index=1&type=section&id=Business%20%26%20Operational%20Highlights) Lantern Pharma advanced LP-184 and LP-300 trials, expanded its RADR® AI platform, and maintained a strong cash position - Enrollment for the LP-184 Phase 1a clinical trial, involving **62-65 patients** with solid tumors, is expected to be completed by the end of **June 2025**[3](index=3&type=chunk) - An additional data readout from the HARMONIC™ Trial (LP-300) in never-smoker NSCLC patients is anticipated in **Q3 2025**, which will include the first data from the Asian expansion cohort[3](index=3&type=chunk) - The **RADR® AI platform** was enhanced with a new module designed to improve the development of **antibody-drug conjugates (ADCs)**[3](index=3&type=chunk) - The company's cash, cash equivalents, and marketable securities of approximately **$19.7 million** as of March 31, 2025, provide an expected operating runway through at least **May 15, 2026**[3](index=3&type=chunk) [AI-Powered Drug Development Pipeline Highlights](index=2&type=section&id=AI-Powered%20Drug%20Development%20Pipeline%20Highlights) The company is advancing lead candidates LP-300 and LP-184, with ongoing trials and new FDA clearances [LP-300 (HARMONIC™ Trial)](index=2&type=section&id=LP-300) - The **Phase 2 HARMONIC™ trial** is evaluating LP-300 in combination with chemotherapy for never-smokers with NSCLC who have progressed after TKI therapy, with enrollment ongoing in the U.S., Japan, and Taiwan[5](index=5&type=chunk) - Preliminary data from the U.S. safety lead-in cohort showed an **86% clinical benefit rate** and a **43% objective response rate**[6](index=6&type=chunk) - Updated results, including data from the Asian expansion cohort, are planned for release in **Q3 2025**[6](index=6&type=chunk) [LP-184](index=2&type=section&id=LP-184) - The Phase 1a trial in solid tumors is expected to complete enrollment in **June 2025**, with a broader clinical data update slated for **Q3 2025**[7](index=7&type=chunk)[8](index=8&type=chunk) - LP-184 has received **FDA Fast Track Designations** for Glioblastoma (GBM) and Triple Negative Breast Cancer (TNBC), along with **four Rare Pediatric Disease Designations**[7](index=7&type=chunk) - The FDA has cleared a **Phase 1b/2 study in TNBC** and another **Phase 1b/2 study in NSCLC** patients with STK11 and/or KEAP1 mutations[9](index=9&type=chunk)[10](index=10&type=chunk)[12](index=12&type=chunk) - An investigator-led clinical trial of LP-184 for recurrent bladder cancer is planned to begin in Denmark during **Q3 2025**[13](index=13&type=chunk) [RADR® A.I. Platform](index=3&type=section&id=RADR%20A.I.%20Platform) The RADR® AI platform expanded to 200 billion oncology data points, aiding biomarker strategies and preparing for module commercialization - The RADR® platform has grown to approximately **200 billion** oncology-focused data points[14](index=14&type=chunk) - The platform has been crucial for developing **LP-184's clinical biomarker strategy** (PTGR1) and identifying combination strategies, such as with PARP inhibitors[15](index=15&type=chunk) - Lantern plans to **publicly release validated AI modules** for use by collaborators and the research community to aid in specific oncology drug development needs[15](index=15&type=chunk) - A proprietary **blood-brain barrier (BBB) permeability prediction algorithm** was advanced with a favorable PCT patent application report, with a publicly available tool planned for launch in **H2 2025**[18](index=18&type=chunk) [Starlight Therapeutics](index=3&type=section&id=Starlight%20Therapeutics) Starlight Therapeutics is preparing for a Phase 1b/2 trial of STAR-001 in GBM, supported by preclinical data, contingent on funding - Starlight Therapeutics is a **wholly-owned subsidiary** focused on developing therapies for CNS and brain cancers[16](index=16&type=chunk) - A **Phase 1b/2 trial** for STAR-001 (LP-184) in recurrent GBM is anticipated to begin in **late 2025**, subject to successful additional funding[16](index=16&type=chunk) - Collaborators at Johns Hopkins provided independent **preclinical confirmation** of LP-184's hypersensitivity in rare pediatric brain tumors, supporting a planned pediatric CNS tumor trial[16](index=16&type=chunk) [First Quarter 2025 Financial Highlights](index=4&type=section&id=First%20Quarter%202025%20Financial%20Highlights) Lantern Pharma ended Q1 2025 with $19.7 million in cash, reporting a reduced net loss of $4.5 million Q1 2025 Financial Summary (vs. Q1 2024) | Financial Metric | Q1 2025 (USD) | Q1 2024 (USD) | | :--- | :--- | :--- | | Cash, Cash Equivalents, & Marketable Securities | ~$19.7 million | Not specified | | Research & Development Expenses | ~$3.3 million | ~$4.3 million | | General & Administrative Expenses | ~$1.5 million | ~$1.5 million | | Net Loss | ~$4.5 million | ~$5.4 million | | Net Loss per Share | $0.42 | $0.51 | - The company's cash position decreased from approximately **$24.0 million** at the end of 2024 to **$19.7 million** as of March 31, 2025[22](index=22&type=chunk) - As of March 31, 2025, there are outstanding warrants to purchase **70,000 shares** of common stock at a weighted-average exercise price of **$18.75 per share**, which expire on **June 10, 2025**[22](index=22&type=chunk) [Forward-Looking Statements](index=5&type=section&id=Forward-Looking%20Statements) This report contains forward-looking statements subject to risks including funding, clinical trial outcomes, and FDA approval processes - The press release includes **forward-looking statements** regarding future events, financial performance, strategic plans, clinical trial timing, and market potential[23](index=23&type=chunk) - Key risks that could cause actual results to differ include the ability to **secure future funding**, the **success of clinical trials**, and the ability to obtain **FDA marketing approval** for its product candidates[23](index=23&type=chunk)

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]