Exhibit 99.1 Lantern Pharma Reports Second Quarter 2025 Financial Results and Business Updates Major milestone achieved with successful completion of enrollment for LP-184 Phase 1a clinical trial, with 65 patients enrolled across a range of solid tumors including glioblastoma (GBM); LP-184 is a potential blockbuster drug-candidate with market potential of $10-12 billion USD in annual revenue. Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) established for LP-184, enabling advancement to upc ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ☐ 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 | | of Incorporation) | File Number) | Identification No.) | 1920 McKinney Avenue, 7th Floor Dallas, Texas 75201 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PU ...

Business Overview & RADR Platform - Lantern leverages A I to rescue and develop cancer therapies, potentially transforming drug development cost, risk, and timelines[5] - The RADR A I platform has grown to over 1 12 billion data points, a ~5x increase since the IPO[12] - RADR rapidly identifies genetic & biomarker signatures for precision oncology drug development with 85%+ blinded prediction success[31] - The data powering the A I platform is on pace to grow ~120x since January 2019[33] Financial Highlights - Completed a $26 3 million IPO on June 15, 2020[13] - Completed a $69 0 million follow-on public offering in January 2021[13] - Cash position does not include $69 0 million (gross) raised in the January 20, 2021 follow-on public offering[26] - Cash runway extended through mid-2025, allowing focus on developing the oncology therapeutics portfolio[13] - Net loss for the year ended December 31, 2020 was $(5,908,190)[18] compared to $(2,428,185) for the year ended December 31, 2019[18] Pipeline Development - Expanded pipeline from 3 drug candidates in 4 tumor targets to 7 disclosed targets[12] - Initiated an Antibody Drug Conjugate ("ADC") platform[12] - Plans to launch a Phase 2 trial for LP-300 in NSCLC (non-smokers) in Q3 2021[41]

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]