Core Insights - The BioMedWire Podcast features an interview with Panna Sharma, CEO of Lantern Pharma, focusing on the company's AI-driven approach to developing targeted cancer therapies [2][4] - Lantern Pharma's RADR® AI platform aims to address the high costs and long timelines associated with cancer drug development, which currently averages $250 billion annually and takes 10 to 12 years with a 93% failure rate [4][7] - The company is currently conducting three clinical trials for potential drug candidates, which could each be valued at several billion USD [2][4] Company Overview - Lantern Pharma is positioned as an AI-first company dedicated to creating innovative cancer medicines, leveraging machine learning and big data to enhance drug discovery [4][7] - The company has a pipeline of clinical-stage drug candidates targeting novel cancer mechanisms, with a focus on precision oncology, particularly in brain cancers [5][7] - Recent developments include the addition of a new board member from a recently acquired brain cancer company, indicating a strategic move to strengthen its expertise in this area [5] Market Outlook - Sharma anticipates significant advancements in treating difficult cancers, especially brain cancers, over the next five to seven years, marking a new era in precision neuro-oncology [5] - The recent approval of three brain cancer drugs after a long drought of 17 years highlights a shift in the market and potential opportunities for innovation in cancer treatment [5]

Lantern Pharma (LTRN) Conference Call Summary Company Overview - Lantern Pharma is a publicly traded biotechnology company focused on developing cancer medicines using artificial intelligence (AI) [5][4] - The company is headquartered in Dallas, Texas, and has a small team of approximately 24 employees [5] Key Points and Arguments Drug Development Strategy - Lantern Pharma utilizes AI to enhance drug development processes, aiming to create new first-in-human drugs and repurpose existing drugs that have failed [5][6] - The company has three drugs in clinical trials: LP-300, LP-184, and LP-284, with LP-300 currently in Phase II and LP-184 recently completing enrollment in a Phase I trial [6][11] - Lantern has received 11 FDA designations, including five orphan designations and two Fast Track designations [7][36] Financial Management - The company maintains a burn rate of approximately $4.5 million per quarter while managing three trials and developing its AI engine [7][37] - Lantern has cash reserves projected to last into 2026, with no debt or toxic overhang [38] AI Platform and Innovations - The AI platform is central to Lantern's operations, allowing for rapid data analysis and drug development [9][10] - A recent public release of a module predicting blood-brain barrier penetrability has generated interest and potential partnerships [34][48] - The AI system is designed to be iterative and continuously learning, enhancing its predictive capabilities over time [32][51] Clinical Trials and Drug Efficacy - LP-300 targets non-small cell lung cancer in never smokers, a population with limited treatment options, representing a $4 billion to $5 billion annual market opportunity [14][21] - Initial results from LP-300 show an 86% clinical benefit rate, with some patients achieving durable complete responses [16][17] - LP-184 is designed for a wide range of solid tumors, with a focus on patients with specific biomarkers that indicate a higher likelihood of response [22][75] - LP-284 targets B-cell malignancies, with promising early results in patients who have failed multiple prior therapies [25][28] Combination Therapies - Lantern is exploring combination therapies, particularly with PARP inhibitors in triple-negative breast cancer and PD-1 inhibitors in non-small cell lung cancer [59][64] - The combination approach aims to enhance treatment efficacy by attacking cancer cells through multiple mechanisms [63][66] Market Opportunities - The never smoker population in Asia presents a significant market opportunity, with a higher incidence of non-small cell lung cancer compared to the U.S. [55][56] - Lantern aims to partner with pharmaceutical companies in Asia to leverage the local patient population for clinical trials [56][57] Additional Important Information - The company is focused on maintaining a disciplined fiscal profile while pursuing innovative drug development [37][38] - Lantern's business model includes licensing developed drugs to larger biotech and pharmaceutical companies [12][33] - The company is committed to using AI for good, aiming to transform cancer therapy development through data-driven insights [30][79] Conclusion - Lantern Pharma is positioned as a forward-thinking biotech company leveraging AI to develop innovative cancer therapies, with a strong focus on precision medicine and combination therapies. The company is actively pursuing partnerships and expanding its clinical trials to address significant unmet medical needs in oncology.

[Q2 2025 Business and Financial Highlights](index=1&type=section&id=Q2%202025%20Business%20and%20Financial%20Highlights) Lantern Pharma achieved significant clinical milestones, including LP-184 Phase 1a completion and complete responses for LP-300 and LP-284, alongside AI platform innovations and a strong financial position [Key Clinical Milestones](index=1&type=section&id=Key%20Clinical%20Milestones) Lantern Pharma achieved significant clinical milestones, including LP-184 Phase 1a completion, MTD/RP2D establishment, and complete responses for LP-300 in NSCLC and LP-284 in DLBCL - LP-184 Phase 1a clinical trial enrollment successfully completed with **65 patients** across various solid tumors, including glioblastoma (GBM)[1](index=1&type=chunk) - Maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D) established for LP-184, enabling advancement to Phase 1b/2 trials for recurrent triple negative breast cancer (TNBC) and recurrent bladder cancer[2](index=2&type=chunk) - A **complete response** was observed in a 70-year-old never-smoker with advanced non-small cell lung cancer (NSCLC) treated with LP-300 in combination with chemotherapy in the HARMONIC™ Trial[3](index=3&type=chunk) - LP-284 achieved a **complete metabolic response** in a 41-year-old patient with aggressive diffuse large B-cell lymphoma (DLBCL) after just **two cycles**, following failure of multiple prior therapies[5](index=5&type=chunk) [AI Platform Innovations](index=1&type=section&id=AI%20Platform%20Innovations) The company launched new AI-powered modules, PredictBBB.ai™ and an enhanced drug combination prediction module, strengthening its RADR platform capabilities - PredictBBB.ai™ module, a proprietary algorithm and machine learning solution for determining blood-brain barrier penetrability, was launched publicly as a RADR module[6](index=6&type=chunk) - The RADR platform was enhanced with an AI-powered drug combination prediction module, based on peer-reviewed research, to improve prediction of synergistic cancer drug combinations[7](index=7&type=chunk) [Financial Overview](index=2&type=section&id=Financial%20Overview) Lantern Pharma reported approximately **$15.9 million** in cash, cash equivalents, and marketable securities as of June 30, 2025, providing an operating runway into June 2026 - Cash, cash equivalents, and marketable securities were approximately **$15.9 million** as of June 30, 2025[9](index=9&type=chunk) - The company expects its existing capital to provide an operating runway at least into June 2026[9](index=9&type=chunk) [Company Overview and CEO Statement](index=2&type=section&id=Company%20Overview%20and%20CEO%20Statement) Lantern Pharma, a clinical-stage biopharmaceutical company, leverages its RADR® AI platform to accelerate oncology drug development, with the CEO highlighting recent clinical successes and AI platform advancements [Introduction and Strategic Vision](index=2&type=section&id=Introduction%20and%20Strategic%20Vision) Lantern Pharma, a clinical-stage biopharmaceutical company, uses its RADR® AI platform to accelerate oncology drug development, with the CEO emphasizing clinical successes and AI platform commercialization - Lantern Pharma is a clinical-stage biopharmaceutical company utilizing its proprietary RADR® AI and machine learning platform to transform oncology drug discovery and development[10](index=10&type=chunk) - CEO Panna Sharma noted **complete responses** in two clinical trials, validating drug mechanisms and therapeutic potential, and emphasized the transformation of the AI platform into functional, accessible modules[11](index=11&type=chunk) - These advancements represent a pivotal inflection point in clinical and technological evolution, reinforcing an AI-driven approach to addressing unmet patient needs with a clear pathway to commercialization[11](index=11&type=chunk) [Operational Highlights](index=2&type=section&id=Operational%20Highlights) Lantern Pharma achieved significant clinical pipeline advancements, strengthened its intellectual property with new patents, and enhanced its RADR AI platform with new modules and expanded data capabilities [Clinical Pipeline Developments](index=2&type=section&id=Clinical%20Pipeline%20Developments) Lantern Pharma significantly advanced its clinical pipeline, with LP-184 completing Phase 1a, LP-300 showing a complete response in NSCLC, and LP-284 achieving its first complete response in refractory DLBCL [LP-184 Program Updates](index=2&type=section&id=LP-184%20Program%20Updates) LP-184 completed Phase 1a enrollment with **65 patients**, established MTD/RP2D, received multiple FDA designations, and demonstrated efficacy in ATRT mouse models, targeting multi-billion dollar markets - LP-184 successfully completed enrollment of its Phase 1a first-in-human trial with **65 patients** across multiple solid tumor indications[12](index=12&type=chunk) - The trial established both the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D), positioning LP-184 for planned Phase 1b/2 studies in recurrent TNBC and recurrent bladder cancer[12](index=12&type=chunk) - LP-184 has received **Fast Track Designations** from the FDA for glioblastoma multiforme (GBM) and triple negative breast cancer (TNBC), and **four Rare Pediatric Disease Designations**[13](index=13&type=chunk) - Independent research at Johns Hopkins validated LP-184 data, demonstrating a **345% improvement in median survival** in the CHLA06 mouse model of ATRT[15](index=15&type=chunk) [LP-300 HARMONIC™ Trial Updates](index=3&type=section&id=LP-300%20HARMONIC%E2%84%A2%20Trial%20Updates) The Phase 2 HARMONIC™ trial observed a **complete response** in an advanced NSCLC patient, completed enrollment of its Japanese cohort, and targets an over **$4 billion** annual market - A remarkable **complete response** was observed in a 70-year-old never-smoker patient with advanced NSCLC in the HARMONIC™ trial[17](index=17&type=chunk) - The Phase 2 HARMONIC™ trial completed enrollment of its Japanese cohort of **10 patients**[18](index=18&type=chunk) - Additional clinical data and findings from the HARMONIC™ Phase 2 trial are anticipated in September 2025[4](index=4&type=chunk) - The market opportunity for the treatment of never-smokers with NSCLC is estimated at over **$4 billion annually**[20](index=20&type=chunk) [LP-284 Program Updates](index=4&type=section&id=LP-284%20Program%20Updates) LP-284 achieved a **complete metabolic response** in a heavily pretreated DLBCL patient, supporting its synthetic lethal mechanism and potential in the **$4 billion** annual global B-cell cancer market - LP-284 exhibited remarkable clinical activity, achieving a **complete metabolic response** in a 41-year-old patient with aggressive Grade 3 DLBCL after just **two doses**[22](index=22&type=chunk) - This patient had previously failed standard R-CHOP/Pola-R-CHP chemotherapy, CAR-T cell therapy, and CD3xCD20 bispecific antibody therapy[22](index=22&type=chunk) - This represents the **first complete response** observed with LP-284, supporting its synthetic lethal mechanism and potential in treating refractory aggressive lymphomas[23](index=23&type=chunk) - The global blood cancer market focused on B-cell cancer is estimated at **$4 billion annually**, with DLBCL affecting approximately **200,000 patients globally** each year[24](index=24&type=chunk) [Intellectual Property Advancements](index=4&type=section&id=Intellectual%20Property%20Advancements) Lantern Pharma strengthened its IP with a European patent allowance for LP-284, extending exclusivity through 2039, and published a PCT patent for its highly accurate BBB permeability prediction AI - The European Patent Office (EPO) issued a notice of allowance for a composition of matter patent covering LP-284, expected to be granted with exclusivity through early **2039**[25](index=25&type=chunk) - This EU patent complements existing composition of matter patents granted in the U.S. (April 2023) and Japan (June 2024)[25](index=25&type=chunk) - Lantern announced the publication of its PCT patent application (PCT/US2024/019851) covering a novel machine learning solution for predicting blood-brain barrier (BBB) permeability[26](index=26&type=chunk) - The predictBBB™ technology demonstrates exceptional performance, processing up to **100,000 molecules per hour** with industry-leading accuracy[26](index=26&type=chunk) [RADR AI Platform Enhancements](index=5&type=section&id=RADR%20AI%20Platform%20Enhancements) Lantern expanded its RADR platform with over **200 billion** data points, launched PredictBBB.ai™ with **94% accuracy**, and introduced an AI module for synergistic drug combinations targeting a **$50 billion** market, planning broader module access - The RADR platform now leverages over **200 billion oncology-focused data points** and a library of **200+ advanced machine learning algorithms**[28](index=28&type=chunk) - The PredictBBB.ai™ module was publicly launched, offering **94% prediction accuracy**, **95% sensitivity**, and **89% specificity** for blood-brain barrier permeability[28](index=28&type=chunk) - An innovative AI-powered module for predicting synergistic cancer drug combinations was introduced, with an initial focus on DNA damaging agents and DNA repair inhibitors[29](index=29&type=chunk) - This drug combination module targets a market opportunity where approximately **$50 billion** is spent annually on the development of combination therapies for cancer[29](index=29&type=chunk) - The company plans to make select RADR modules available to the broader scientific and research community to foster collaborative innovation and create potential new revenue streams[30](index=30&type=chunk) [Financial Results for Second Quarter 2025](index=5&type=section&id=Financial%20Results%20for%20Second%20Quarter%202025) Lantern Pharma reported its Q2 2025 financial results, highlighting balance sheet figures, operating expenses, net loss, capitalization details, and a decision regarding the earnings call [Balance Sheet Highlights](index=5&type=section&id=Balance%20Sheet%20Highlights) As of June 30, 2025, Lantern Pharma held approximately **$15.9 million** in cash, cash equivalents, and marketable securities, a decrease from **$24.0 million** at year-end 2024, providing an operating runway into June 2026 - Cash, cash equivalents, and marketable securities were approximately **$15.9 million** as of June 30, 2025[31](index=31&type=chunk) - This compares to approximately **$24.0 million** as of December 31, 2024[31](index=31&type=chunk) - The company believes its existing capital will fund operating expenses and capital expenditure requirements at least into June 2026[31](index=31&type=chunk) [Operating Expenses](index=6&type=section&id=Operating%20Expenses) R&D expenses decreased to approximately **$3.1 million** in Q2 2025 from **$3.9 million** in Q2 2024, while G&A expenses slightly increased to **$1.6 million** Operating Expenses (Three Months Ended June 30) | Expense Category | Q2 2025 (approx.) | Q2 2024 (approx.) | Change (YoY) | | :----------------------- | :---------------- | :---------------- | :----------- | | Research and Development | $3.1 million | $3.9 million | -$0.8 million (↓20.5%) | | General and Administrative | $1.6 million | $1.5 million | +$0.1 million (↑6.7%) | [Net Loss and EPS](index=6&type=section&id=Net%20Loss%20and%20EPS) Lantern Pharma reported a net loss of approximately **$4.33 million** (or **$0.40 per share**) for Q2 2025, an improvement from **$4.96 million** (or **$0.46 per share**) in Q2 2024 Net Loss and EPS (Three Months Ended June 30) | Metric | Q2 2025 (approx.) | Q2 2024 (approx.) | Change (YoY) | | :----------------------- | :---------------- | :---------------- | :----------- | | Net Loss | $(4.33) million | $(4.96) million | +$0.63 million (↓12.7%) | | Net Loss per Share | $(0.40) | $(0.46) | +$0.06 (↓13.0%) | [Capitalization](index=6&type=section&id=Capitalization) As of June 30, 2025, the company had **10,784,725 shares** of common stock outstanding, **1,239,766 options** at **$5.72 per share**, and no outstanding warrants - As of June 30, 2025, the Company had **10,784,725 shares** of common stock outstanding[34](index=34&type=chunk) - Options to purchase **1,239,766 shares** of common stock were outstanding at a weighted average exercise price of **$5.72 per share**[34](index=34&type=chunk) - There were no outstanding warrants as of June 30, 2025[34](index=34&type=chunk) [Earnings Call Decision](index=6&type=section&id=Earnings%20Call%20Decision) Lantern Pharma decided not to host a quarterly earnings call, opting to use webinars, digital media, and social media for stockholder communication instead - Lantern has determined not to host a quarterly earnings call at the present time due to resource concentration[35](index=35&type=chunk) - The company plans to focus resources on other distribution channels like webinars, digital media resources, and broader social media channels for stockholder communication[35](index=35&type=chunk) [Condensed Consolidated Financial Statements](index=7&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This section presents the unaudited condensed consolidated balance sheets and statements of operations for Lantern Pharma, detailing assets, liabilities, equity, and net loss [Condensed Consolidated Balance Sheets](index=7&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) Unaudited balance sheets show total assets decreased from **$25.57 million** (Dec 2024) to **$17.42 million** (June 2025), with total stockholders' equity decreasing from **$21.19 million** to **$12.52 million** Condensed Consolidated Balance Sheets (Unaudited) | | June 30, 2025 | December 31, 2024 | | :------------------------------------ | :-------------- | :---------------- | | Cash and cash equivalents | $6,061,408 | $7,511,079 | | Marketable securities | $9,840,366 | $16,501,984 | | Total current assets | $17,200,790 | $25,247,629 | | Total assets | $17,420,292 | $25,571,792 | | Total current liabilities | $4,884,363 | $4,331,175 | | Total liabilities | $4,897,887 | $4,384,018 | | Total stockholders' equity | $12,522,405 | $21,187,774 | | Accumulated deficit | $(84,893,415) | $(76,025,617) | [Condensed Consolidated Statements of Operations](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) Unaudited statements of operations show a Q2 2025 net loss of **$4.33 million** (**$0.40 per share**), an improvement from Q2 2024, and a six-month net loss of **$8.87 million** (**$0.82 per share**) Condensed Consolidated Statements of Operations (Unaudited) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | General and administrative | $1,583,521 | $1,519,724 | $3,093,598 | $3,000,939 | | Research and development | $3,068,379 | $3,888,737 | $6,332,334 | $8,139,523 | | Total operating expenses | $4,651,900 | $5,408,461 | $9,425,932 | $11,140,462 | | Loss from operations | $(4,651,900) | $(5,408,461) | $(9,425,932) | $(11,140,462) | | Interest income | $114,745 | $188,660 | $264,535 | $389,610 | | Other income, net | $206,140 | $260,295 | $293,599 | $350,536 | | NET LOSS | $(4,331,015) | $(4,959,506) | $(8,867,798) | $(10,400,316) | | Net loss per share (basic and diluted)| $(0.40) | $(0.46) | $(0.82) | $(0.97) | | Weighted-average common shares outstanding | 10,784,725 | 10,758,805 | 10,784,725 | 10,750,801 | [About Lantern Pharma](index=8&type=section&id=About%20Lantern%20Pharma) Lantern Pharma is an AI company transforming oncology drug discovery and development through its proprietary RADR® platform, accelerating programs from AI insights to clinical trials [Company Profile and AI Platform](index=8&type=section&id=Company%20Profile%20and%20AI%20Platform) Lantern Pharma is an AI company transforming oncology drug discovery via its RADR® platform, leveraging over **200 billion** data points and **200+ ML algorithms** to accelerate drug programs to clinical trials in **2-3 years** for **$1.0 - 2.5 million** per program - Lantern Pharma (NASDAQ: LTRN) is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development[41](index=41&type=chunk) - Its proprietary AI and machine learning (ML) platform, RADR®, leverages over **200 billion oncology-focused data points** and a library of **200+ advanced ML algorithms**[41](index=41&type=chunk) - Newly developed drug programs have been advanced from initial AI insights to first-in-human clinical trials in **2-3 years** and at approximately **$1.0 - 2.5 million per program**[41](index=41&type=chunk) [Forward-Looking Statements](index=9&type=section&id=Forward-Looking%20Statements) This section provides a disclaimer regarding forward-looking statements, outlining potential risks and advising investors to consult the company's Form 10-K for detailed risk factors [Disclaimer and Risk Factors](index=9&type=section&id=Disclaimer%20and%20Risk%20Factors) This section contains forward-looking statements subject to risks like funding, clinical outcomes, and FDA approvals, cautioning investors to review the Annual Report on Form 10-K for detailed risk factors - The press release contains forward-looking statements regarding future events, financial performance, drug candidate development, clinical trial timing, market estimates, and commercialization plans[43](index=43&type=chunk) - Important factors could cause actual results to differ materially, including risks related to future funding, consistency of clinical observations, research success, licensing/partnerships, and FDA marketing approval[43](index=43&type=chunk) - Investors are cautioned not to place undue reliance on these statements and are directed to the Risk Factors section in the Annual Report on Form 10-K for the year ended December 31, 2024[43](index=43&type=chunk) [Disclosure Channels to Disseminate Information](index=9&type=section&id=Disclosure%20Channels%20to%20Disseminate%20Information) Lantern Pharma utilizes various public channels, including its website, press releases, and social media, to broadly disseminate material information to investors and the public [Public Information Dissemination](index=9&type=section&id=Public%20Information%20Dissemination) Lantern Pharma disseminates material information through its website, press releases, SEC filings, digital newsletters, and social media to ensure broad, non-exclusionary public distribution - Lantern Pharma announces material information through its website, press releases, SEC filings, digital newsletters, and social media[44](index=44&type=chunk) - These channels are used to achieve broad, non-exclusionary distribution of information to the public[44](index=44&type=chunk) - Investors are encouraged to review the information made public in these locations as it could be deemed material[44](index=44&type=chunk) [Contacts](index=9&type=section&id=Contacts) This section provides contact information for investor relations inquiries [Investor Relations Contact](index=9&type=section&id=Investor%20Relations%20Contact) For investor relations inquiries, contact Lantern Pharma's Investor Relations team via email - Investor Relations Contact: ir@lanternpharma.com[45](index=45&type=chunk)

[FORWARD-LOOKING STATEMENTS](index=3&type=section&id=FORWARD-LOOKING%20STATEMENTS) This report contains forward-looking statements regarding company strategy and financial projections, which are subject to substantial risks - This Quarterly Report on Form 10-Q contains forward-looking statements regarding the company's strategy, future preclinical studies and clinical trials, financial position, projected costs, and management objectives[12](index=12&type=chunk) - Key forward-looking statements include the ability to secure funding, the potential advantages of the RADR platform, strategic plans for drug candidate development and data expansion, R&D efforts, and the intention to leverage AI, machine learning, and biomarker data[13](index=13&type=chunk) - Readers are cautioned not to place undue reliance on forward-looking statements as actual results may differ materially due to various factors, including those discussed in the **Risk Factors section of the 2024 Form 10-K**[14](index=14&type=chunk)[15](index=15&type=chunk) [PART I – FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20%E2%80%93%20FINANCIAL%20INFORMATION) This part presents the company's unaudited financial statements and management's discussion and analysis for the reporting period [Item 1. Financial Statements.](index=5&type=section&id=Item%201.%20Financial%20Statements.) This section presents the unaudited condensed consolidated financial statements for the periods ended June 30, 2025, and December 31, 2024 [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet reflects a decrease in total assets and stockholders' equity driven by lower cash and marketable securities | Metric | June 30, 2025 (Unaudited) | December 31, 2024 | | :-------------------------------- | :------------------------ | :------------------ | | **Assets** | | | | Cash and cash equivalents | $6,061,408 | $7,511,079 | | Marketable securities | $9,840,366 | $16,501,984 | | Total current assets | $17,200,790 | $25,247,629 | | Total assets | $17,420,292 | $25,571,792 | | **Liabilities** | | | | Accounts payable and accrued expenses | $4,752,848 | $4,140,361 | | Total current liabilities | $4,884,363 | $4,331,175 | | Total liabilities | $4,897,887 | $4,384,018 | | **Stockholders' Equity** | | | | Total stockholders' equity | $12,522,405 | $21,187,774 | - **Total assets decreased by approximately $8.15 million** from December 31, 2024, to June 30, 2025, primarily due to reductions in marketable securities and cash and cash equivalents[21](index=21&type=chunk) - **Total stockholders' equity decreased by approximately $8.67 million**, largely driven by accumulated deficit from net losses[21](index=21&type=chunk) [Condensed Consolidated Statements of Operations](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company's net loss decreased year-over-year due to a significant reduction in research and development expenses | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | General and administrative expenses | $1,583,521 | $1,519,724 | $3,093,598 | $3,000,939 | | Research and development expenses | $3,068,379 | $3,888,737 | $6,332,334 | $8,139,523 | | Total operating expenses | $4,651,900 | $5,408,461 | $9,425,932 | $11,140,462 | | Loss from operations | $(4,651,900) | $(5,408,461) | $(9,425,932) | $(11,140,462) | | Interest income | $114,745 | $188,660 | $264,535 | $389,610 | | Other income, net | $206,140 | $260,295 | $293,599 | $350,536 | | NET LOSS | $(4,331,015) | $(4,959,506) | $(8,867,798) | $(10,400,316) | | Net loss per share (basic and diluted) | $(0.40) | $(0.46) | $(0.82) | $(0.97) | - **Net loss decreased** for both the three and six months ended June 30, 2025, compared to the same periods in 2024, primarily due to a reduction in research and development expenses[23](index=23&type=chunk) - **Research and development expenses decreased by 21%** for the three months and **22% for the six months** ended June 30, 2025, year-over-year[23](index=23&type=chunk) [Condensed Consolidated Statements of Comprehensive Loss](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Comprehensive%20Loss) Comprehensive loss narrowed year-over-year, though other comprehensive income shifted to a loss due to market factors | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :------------------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | NET LOSS | $(4,331,015) | $(4,959,506) | $(8,867,798) | $(10,400,316) | | Other comprehensive (loss) income | $(83,691) | $(8,445) | $(105,947) | $100,875 | | Comprehensive loss | $(4,414,706) | $(4,967,951) | $(8,973,745) | $(10,299,441) | - The company reported a **comprehensive loss of $4,414,706** for the three months ended June 30, 2025, and **$8,973,745 for the six months** ended June 30, 2025[25](index=25&type=chunk) - **Other comprehensive loss for the six months ended June 30, 2025, was $(105,947)**, a significant change from the income of $100,875 in the prior year, primarily due to unrealized losses on foreign currency translation and available-for-sale securities[25](index=25&type=chunk) [Condensed Consolidated Statements of Changes in Stockholders' Equity](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Stockholders'%20Equity) Stockholders' equity declined significantly in the first half of 2025, primarily due to the net loss incurred during the period | Metric | December 31, 2024 | June 30, 2025 | | :-------------------------- | :------------------ | :------------------ | | Total Stockholders' Equity | $21,187,774 | $12,522,405 | | Accumulated Deficit | $(76,025,617) | $(84,893,415) | | Additional Paid-in Capital | $97,058,323 | $97,366,699 | | Accumulated Other Comprehensive Income | $153,990 | $48,043 | - **Total stockholders' equity decreased by approximately $8.67 million** from December 31, 2024, to June 30, 2025, primarily due to the net loss incurred during the period[27](index=27&type=chunk) - Stock-based compensation contributed **$308,376 to additional paid-in capital** during the six months ended June 30, 2025[27](index=27&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Cash flow from investing activities turned positive due to redemptions of marketable securities, offsetting operating cash usage | Cash Flow Activity | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--------------------------------------- | :----------------------------- | :----------------------------- | | Net cash flows used in operating activities | $(8,312,887) | $(8,259,161) | | Net cash flows provided by (used in) investing activities | $6,832,489 | $(758,231) | | Net cash flows provided by financing activities | $- | $54,716 | | Change in cash and cash equivalents | $(1,449,671) | $(8,961,184) | | Cash and cash equivalents, end of period | $6,061,408 | $12,976,565 | - **Net cash used in operating activities slightly increased to $8,312,887** for the six months ended June 30, 2025, compared to $8,259,161 in the prior year[29](index=29&type=chunk) - Investing activities shifted from a net cash outflow of $758,231 in 2024 to a **net cash inflow of $6,832,489 in 2025**, primarily due to increased net redemptions of marketable securities[29](index=29&type=chunk) [Notes to Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed explanations of the company's accounting policies, financial position, and operational activities [Note 1. Organization, Principal Activities, and Basis of Presentation](index=10&type=section&id=Note%201.%20Organization,%20Principal%20Activities,%20and%20Basis%20of%20Presentation) Lantern Pharma is an AI-driven company developing targeted oncology therapies using its proprietary RADR platform - Lantern Pharma Inc is an AI-focused company dedicated to developing cancer therapies and transforming oncology drug discovery and development[31](index=31&type=chunk) - The company's **RADR AI platform** uses big data analytics and machine learning to identify drug candidates and patient populations likely to respond[31](index=31&type=chunk) - The development portfolio includes three clinical-stage oncology candidates: **LP-300 (Phase 2 for NSCLC)**, **LP-184/STAR-001 (Phase 1 for solid tumors and CNS cancers)**, and **LP-284 (Phase 1 for hematological cancers)**, plus an ADC program[33](index=33&type=chunk)[34](index=34&type=chunk) [Note 2. Liquidity and Going Concern](index=11&type=section&id=Note%202.%20Liquidity%20and%20Going%20Concern) Significant net losses raise substantial doubt about the company's ability to continue as a going concern without additional funding | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------- | :----------------------------- | :----------------------------- | | Net Loss | $(8,868,000) | $(10,400,000) | | Working Capital (as of June 30, 2025) | $12,316,000 | N/A | - The company's ability to continue as a going concern is **highly contingent on raising additional capital** for ongoing research and development and clinical trials[38](index=38&type=chunk) - In July 2025, the company entered into an **ATM Sales Agreement to sell up to $15,530,000 of common stock** to support capital needs[37](index=37&type=chunk) [Note 3. Summary of Significant Accounting Policies](index=11&type=section&id=Note%203.%20Summary%20of%20Significant%20Accounting%20Policies) This note outlines key accounting policies for estimates, taxes, R&D costs, marketable securities, and other financial items [Use of Estimates and Assumptions](index=11&type=section&id=Use%20of%20Estimates%20and%20Assumptions) Financial statement preparation requires management to make estimates and assumptions, particularly for R&D accruals, fair value of equity-based awards, lease payments, and marketable securities[39](index=39&type=chunk) [Income Taxes](index=11&type=section&id=Income%20Taxes) - Due to operating losses, the company has **no corporate income tax liabilities** and has recorded a full valuation allowance on its deferred tax assets[40](index=40&type=chunk) - The company is assessing the potential impact of the recently enacted **One Big Beautiful Bill Act (OBBB)** on future gross tax assets and liabilities[41](index=41&type=chunk) [Foreign Currency](index=12&type=section&id=Foreign%20Currency) Financial statements of the Australian subsidiary (functional currency: AUD) are translated to USD, with translation gains/losses recorded in accumulated other comprehensive income (loss)[42](index=42&type=chunk) [Risks and Uncertainties](index=12&type=section&id=Risks%20and%20Uncertainties) - The company operates in an industry subject to intense competition, government regulation, and rapid technological change, facing financial, operational, technological, and regulatory risks[43](index=43&type=chunk) - Marketable securities are subject to interest rate, market, and credit risks, and **cash balances may exceed FDIC insurance limits**[44](index=44&type=chunk) - Reliance on foreign third-party manufacturers and service providers exposes the company to risks from changes in U.S. and international trade policies, including tariffs[45](index=45&type=chunk) [Research and Development](index=13&type=section&id=Research%20and%20Development) Research and development costs, including payroll, contractor expenses, research studies, manufacturing, clinical site costs, and technical infrastructure for the RADR platform, are expensed as incurred[47](index=47&type=chunk) [Cash and Cash Equivalents](index=13&type=section&id=Cash%20and%20Cash%20Equivalents) | Metric | June 30, 2025 | December 31, 2024 | | :---------------- | :-------------- | :---------------- | | Cash Equivalents | $4,617,000 | $6,619,000 | - Cash equivalents include money market funds and other highly liquid instruments with original maturities of 3 months or less[48](index=48&type=chunk) [Leases](index=13&type=section&id=Leases) - Operating leases are recognized on the balance sheet as right-of-use (ROU) assets and lease liabilities, based on the present value of future minimum lease payments[49](index=49&type=chunk) - Short-term leases (12 months or less) are expensed on a straight-line basis and do not result in ROU assets or lease liabilities[49](index=49&type=chunk) [Marketable Securities](index=13&type=section&id=Marketable%20Securities) - Marketable securities, including government and agency securities, corporate bonds, mutual funds, and common stock, are classified as **available-for-sale** and recorded at fair value[50](index=50&type=chunk)[51](index=51&type=chunk) - Unrealized gains and losses on available-for-sale debt securities are recorded in accumulated other comprehensive income (loss), while changes in fair value of equity securities are recorded in other income, net[51](index=51&type=chunk)[52](index=52&type=chunk) [Recent Accounting Pronouncements](index=14&type=section&id=Recent%20Accounting%20Pronouncements) - The company is assessing the impact of **ASU 2023-09 (Income Taxes)** effective for the 2025 annual period, which requires enhanced income tax disclosures[54](index=54&type=chunk) - The company is also assessing **ASU 2024-03 (Expense Disaggregation Disclosures)** effective for annual periods beginning after December 15, 2026, which requires disaggregated income statement expense disclosures[55](index=55&type=chunk) [Note 4. Commitments and Contingencies](index=14&type=section&id=Note%204.%20Commitments%20and%20Contingencies) The company maintains various research and license agreements, with related expenses decreasing year-over-year [General](index=14&type=section&id=General) - The company engages in various agreements (license, strategic alliance, research service) for product candidate advancement and R&D efforts[56](index=56&type=chunk) - CRO services for the LP-300 Phase 2 clinical trial are transitioning from Fortrea Inc to other service providers as of July 2025[57](index=57&type=chunk) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Amount Expensed for License, Strategic Alliance, and Research Agreements | $1,133,000 | $1,639,000 | $2,314,000 | $3,741,000 | | Amount accrued and payable (June 30, 2025) | $1,382,000 | N/A | N/A | N/A | | Amount accrued and payable (December 31, 2024) | N/A | N/A | N/A | $1,725,000 | | Prepaid expenses and other current assets (June 30, 2025) | $368,000 | N/A | N/A | N/A | | Prepaid expenses and other current assets (December 31, 2024) | N/A | N/A | N/A | $490,000 | [Actuate Therapeutics](index=15&type=section&id=Actuate%20Therapeutics) - The company collaborates with Actuate Therapeutics, Inc to utilize its RADR® platform for biomarker-derived signatures for Actuate's product candidates[63](index=63&type=chunk) - As of June 30, 2025, the company holds **13,889 shares of Actuate common stock** with a fair value of approximately **$85,000**, down from $111,000 at December 31, 2024[64](index=64&type=chunk) [Note 5. Leases](index=16&type=section&id=Note%205.%20Leases) The company's operating lease assets and liabilities decreased, with future minimum lease payments totaling $151,801 | Metric | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :-------------- | :---------------- | | Operating lease, right-of-use asset, net | $143,240 | $239,985 | | Total operating lease liabilities | $145,039 | $243,657 | | Weighted average remaining term (years) | 0.89 | 1.31 | | Weighted average discount rate | 9.50% | 9.03% | - Future estimated minimum lease payments under non-cancelable operating leases total **$151,801**, with $97,057 due in the remaining six months of 2025 and $54,744 in 2026[66](index=66&type=chunk) | Lease Expense Component | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Operating lease cost | $53,000 | $45,000 | $106,000 | $90,000 | | Short-term lease cost | $4,800 | $4,800 | $9,600 | $9,300 | | Total lease expense | $57,800 | $49,800 | $115,600 | $99,300 | [Note 6. Stockholders' Equity](index=17&type=section&id=Note%206.%20Stockholders'%20Equity) The company initiated an ATM Sales Agreement in July 2025 while all outstanding warrants expired unexercised [Common Stock](index=17&type=section&id=Common%20Stock) - As of June 30, 2025, and December 31, 2024, **10,784,725 shares of Common Stock** were issued and outstanding[71](index=71&type=chunk) - In July 2025, the company entered an **ATM Sales Agreement to sell up to $15,530,000 of common stock**, with 15,185 shares sold for approximately $80,000 through August 12, 2025[72](index=72&type=chunk) [Warrants](index=17&type=section&id=Warrants) - No warrant exercises occurred during the three or six months ended June 30, 2025[73](index=73&type=chunk) - **All outstanding warrants expired unexercised** by June 30, 2025, resulting in no outstanding warrants[73](index=73&type=chunk) [Options](index=18&type=section&id=Options) | Metric | June 30, 2025 | | :------------------------ | :-------------- | | Options Outstanding | 1,239,766 | | Weighted Average Exercise Price | $5.72 | | Exercisable Options | 1,057,353 | | Weighted Average Exercise Price (Exercisable) | $5.95 | | Stock-based Compensation | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | General and administrative | $65,791 | $56,051 | $139,544 | $112,296 | | Research and development | $94,835 | $78,120 | $168,832 | $155,932 | | Total | $160,626 | $134,171 | $308,376 | $268,228 | [Note 7. Marketable Securities](index=18&type=section&id=Note%207.%20Marketable%20Securities) Marketable securities totaled $9.8 million, consisting primarily of government and agency debt securities with minor unrealized losses | Security Type | Aggregate Fair Value (June 30, 2025) | | :------------------------------ | :----------------------------------- | | Government and agency debt securities | $9,951,540 | | Equity securities | $4,505,440 | | Total | $14,456,980 | | Included in cash and cash equivalents | $4,616,614 | | Included in marketable securities | $9,840,366 | - All debt securities are **due within one year**, totaling $9,951,540 as of June 30, 2025[76](index=76&type=chunk) - **Unrealized losses on government and agency debt securities were $453**, all for less than 12 months, and are not believed to represent credit losses[77](index=77&type=chunk) [Note 8. Fair Value Measurements](index=19&type=section&id=Note%208.%20Fair%20Value%20Measurements) All marketable securities are classified as Level 1 or Level 2 for fair value measurement, with no assets using Level 3 inputs - Fair value measurements are based on a hierarchy: **Level 1** (quoted prices in active markets for identical assets), **Level 2** (observable inputs for similar assets), and **Level 3** (unobservable inputs)[78](index=78&type=chunk)[79](index=79&type=chunk)[80](index=80&type=chunk) | Description | Total Fair Value (June 30, 2025) | Level 1 | Level 2 | Level 3 | | :------------------------------ | :------------------------------- | :-------- | :-------- | :-------- | | Government and agency debt securities | $9,951,540 | $- | $9,951,540 | $- | | Money markets | $626,569 | $626,569 | $- | $- | | Mutual funds – fixed income | $2,922,809 | $2,922,809 | $- | $- | | Mutual funds – alternative investments | $871,200 | $871,200 | $- | $- | | Common stock | $84,862 | $84,862 | $- | $- | | Total | $14,456,980 | $4,505,440 | $9,951,540 | $- | - All marketable securities are classified as **Level 1 or Level 2**, with no financial assets measured using Level 3 inputs[82](index=82&type=chunk) [Note 9. Loss Per Share of Common Shares](index=20&type=section&id=Note%209.%20Loss%20Per%20Share%20of%20Common%20Shares) Potentially dilutive securities are excluded from the diluted loss per share calculation due to the company's net loss position | Metric | June 30, 2025 | June 30, 2024 | | :-------------------------------- | :-------------- | :-------------- | | Warrants to purchase common stock | - | 81,496 | | Stock options | 1,239,766 | 1,063,548 | | Total potentially dilutive securities | 1,239,766 | 1,145,044 | - Due to net losses, potentially dilutive securities (warrants and stock options) are **excluded from diluted loss per share calculations** as their effect would be anti-dilutive[84](index=84&type=chunk) [Note 10. Segment Reporting](index=20&type=section&id=Note%2010.%20Segment%20Reporting) The company operates as a single operating segment, with the CEO acting as the chief operating decision maker - The company operates as **one operating segment**, with its chief executive officer acting as the chief operating decision maker (CODM)[85](index=85&type=chunk) - CODM uses R&D study and material costs, cash balances, operating losses, and budget projections to assess performance and allocate resources[85](index=85&type=chunk) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------------------------- | :----------------------------- | :----------------------------- | | Research and development study and material costs | $4,072,000 | $5,848,000 | | Three Months Ended June 30, 2025 | $1,946,000 | N/A | | Three Months Ended June 30, 2024 | N/A | $2,730,000 | [Item 2. 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.) This section provides management's perspective on the company's financial condition, operational results, and strategic focus [Overview](index=21&type=section&id=Overview) Lantern Pharma is an AI-driven company developing targeted cancer therapies by leveraging its proprietary RADR® data platform - Lantern Pharma is an AI-focused company dedicated to developing cancer therapies, leveraging its proprietary **RADR® platform with over 200 billion data points** to streamline drug discovery and development[87](index=87&type=chunk) - The company has three lead small molecule drug candidates (**LP-300, LP-184, LP-284**) in active clinical programs for various cancer indications, and an Antibody-Drug Conjugate (ADC) program in preclinical research[88](index=88&type=chunk)[91](index=91&type=chunk) - The strategy involves developing new drug candidates and 'rescuing' historical drug candidates by using AI and genomic data to target specific patient populations, aiming to **reduce development time and cost**[89](index=89&type=chunk)[90](index=90&type=chunk) [Components of Our Results of Operations](index=23&type=section&id=Components%20of%20Our%20Results%20of%20Operations) The company's results are primarily driven by research and development expenses across its drug programs and AI platform - The company has **not recognized any revenues** for the three and six-month periods ended June 30, 2025 and 2024[99](index=99&type=chunk) | Research and Development Project | Three Months Ended June 30, 2025 | Six Months Ended June 30, 2025 | | :------------------------------- | :------------------------------- | :----------------------------- | | LP-300 | $1,164,748 | $2,172,656 | | LP-184 | $1,272,370 | $2,633,833 | | LP-284 | $275,957 | $732,428 | | LP-100 | $31,250 | $60,650 | | ADC Program | $7,999 | $14,376 | | RADR Platform | $263,564 | $517,143 | | Other | $52,491 | $201,248 | | Total research and development expenses | $3,068,379 | $6,332,334 | - General and administrative expenses primarily consist of salaries, professional fees, insurance, and occupancy costs, and are expected to fluctuate and increase with clinical trials and potential commercialization[102](index=102&type=chunk)[103](index=103&type=chunk) [Summary Results of Operations for the Three and Six Months Ended June 30, 2025 and 2024 (unaudited)](index=24&type=section&id=Summary%20Results%20of%20Operations%20for%20the%20Three%20and%20Six%20Months%20Ended%20June%2030,%202025%20and%202024%20(unaudited)) Net loss decreased for both the three and six-month periods in 2025 compared to 2024, driven by lower R&D spending | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :----------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | General and administrative expenses | $1,583,521 | $1,519,724 | $3,093,598 | $3,000,939 | | Research and development expenses | $3,068,379 | $3,888,737 | $6,332,334 | $8,139,523 | | Total operating expenses | $4,651,900 | $5,408,461 | $9,425,932 | $11,140,462 | | Loss from operations | $(4,651,900) | $(5,408,461) | $(9,425,932) | $(11,140,462) | | Interest income | $114,745 | $188,660 | $264,535 | $389,610 | | Other income, net | $206,140 | $260,295 | $293,599 | $350,536 | | NET LOSS | $(4,331,015) | $(4,959,506) | $(8,867,798) | $(10,400,316) | [Comparison of the Three Months Ended June 30, 2025 and 2024](index=24&type=section&id=Comparison%20of%20the%20Three%20Months%20Ended%20June%2030,%202025%20and%202024) For Q2 2025, R&D expenses decreased by 21% while G&A expenses saw a modest 4% increase compared to Q2 2024 [General and Administrative Expenses](index=24&type=section&id=General%20and%20Administrative%20Expenses) General and administrative expenses **increased by approximately $64,000 (4%) to $1,584,000**, driven by higher professional fees, patent costs, payroll, and corporate insurance, partially offset by decreases in business development and office fees[105](index=105&type=chunk) [Research and Development Expenses](index=24&type=section&id=Research%20and%20Development%20Expenses) Research and development expenses **decreased by approximately $821,000 (21%) to $3,068,000**, primarily due to decreases in research studies, consulting, and payroll, partially offset by increased licensing expenses[106](index=106&type=chunk) [Interest and Other Income, Net](index=24&type=section&id=Interest%20and%20Other%20Income,%20Net) **Interest income decreased by $74,000 (39%) to $115,000**[107](index=107&type=chunk) - Other income, net, decreased by $54,000 to $206,000, mainly due to lower dividend income, partially offset by foreign currency gains and investment income[107](index=107&type=chunk) [Comparison of the Six Months Ended June 30, 2025 and 2024](index=25&type=section&id=Comparison%20of%20the%20Six%20Months%20Ended%20June%2030,%202025%20and%202024) For H1 2025, R&D expenses decreased by 22% while G&A expenses increased by 3% compared to H1 2024 [General and Administrative Expenses](index=25&type=section&id=General%20and%20Administrative%20Expenses) General and administrative expenses **increased by approximately $93,000 (3%) to $3,094,000**, primarily due to higher professional fees, payroll, corporate insurance, patent/legal expenses, and rent, offset by decreases in business development and travel expenses[109](index=109&type=chunk) [Research and Development Expenses](index=25&type=section&id=Research%20and%20Development%20Expenses) Research and development expenses **decreased by approximately $1,807,000 (22%) to $6,332,000**, mainly due to decreases in research studies, payroll, and consulting, partially offset by increases in licensing and research materials expenses[110](index=110&type=chunk) [Interest and Other Income, Net](index=25&type=section&id=Interest%20and%20Other%20Income,%20Net) **Interest income decreased by $125,000 to $265,000**[111](index=111&type=chunk) - Other income, net, decreased by $57,000 to $294,000, primarily due to lower dividend income, partially offset by foreign currency gains and investment income[111](index=111&type=chunk) [Cash Flows](index=25&type=section&id=Cash%20Flows) Investing activities provided a significant cash inflow in H1 2025, contrasting with a cash outflow in the prior year [Operating Activities](index=25&type=section&id=Operating%20Activities) **Net cash used in operating activities increased slightly to approximately $8,313,000** for the six months ended June 30, 2025, primarily due to a smaller increase in accounts payable and accrued expenses compared to the prior year[113](index=113&type=chunk) [Investing Activities](index=25&type=section&id=Investing%20Activities) **Net cash provided by investing activities was approximately $6,832,000** for the six months ended June 30, 2025, a significant shift from $758,000 used in the prior year, driven by increased net redemptions of marketable securities[114](index=114&type=chunk) [Financing Activities](index=25&type=section&id=Financing%20Activities) **No financing activities occurred** during the six months ended June 30, 2025, compared to $55,000 provided by warrant exercises in the prior year[115](index=115&type=chunk) [Operating Capital and Capital Expenditure Requirements](index=26&type=section&id=Operating%20Capital%20and%20Capital%20Expenditure%20Requirements) The company requires substantial additional funding to sustain operations beyond June 2026 due to ongoing losses - As of June 30, 2025, the company had **$17.4 million in total assets**, **$12.3 million in working capital**, and **$15.9 million in cash, cash equivalents, and marketable securities**[116](index=116&type=chunk) - Existing liquidity is expected to **fund operations into June 2026**, but substantial additional funding is needed due to anticipated ongoing losses and negative operating cash flows, raising substantial doubt about the company's ability to continue as a going concern[116](index=116&type=chunk)[117](index=117&type=chunk) - Future expenses are expected to increase substantially as the company continues clinical development, initiates new trials, expands its drug candidate portfolio, protects intellectual property, pursues regulatory approvals, and builds commercial infrastructure[119](index=119&type=chunk)[121](index=121&type=chunk) [Critical Accounting Estimates](index=27&type=section&id=Critical%20Accounting%20Estimates) There were no changes to the company's critical accounting estimates during the first six months of 2025 - There have been **no changes** to the company's critical accounting estimates during the six months ended June 30, 2025[123](index=123&type=chunk) [Quantitative and Qualitative Disclosure About Market Risk](index=27&type=section&id=Quantitative%20and%20Qualitative%20Disclosure%20About%20Market%20Risk) The company's primary market risk is interest rate sensitivity affecting its investment portfolio and income - The primary market risk exposure is **interest rate sensitivity**, which can affect the market value of fixed-rate securities and future investment income[124](index=124&type=chunk) - The company has **no long-term debt** and does not believe its cash and cash equivalents have significant default or illiquidity risk, though cash balances may exceed federally insured limits[125](index=125&type=chunk)[127](index=127&type=chunk) - **Foreign currency gains of approximately $130,000** were experienced for the six months ended June 30, 2025, related to the Australian subsidiary, but the impact of future foreign currency losses is not expected to be material[128](index=128&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk.](index=28&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) The company is exempt from this item's requirements due to its status as a Smaller Reporting Company - As a **Smaller Reporting Company**, Lantern Pharma Inc is exempt from the requirements of Item 3[130](index=130&type=chunk) [Item 4. Controls and Procedures.](index=28&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management concluded that the company's disclosure controls and procedures were effective as of the end of the reporting period [Evaluation of Disclosure Controls and Procedures.](index=28&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures.) - Management, with CEO and CFO participation, evaluated disclosure controls and procedures as of June 30, 2025[131](index=131&type=chunk) - Disclosure controls and procedures were concluded to be **effective at the reasonable assurance level**[132](index=132&type=chunk) [Changes in Internal Control Over Financial Reporting.](index=28&type=section&id=Changes%20in%20Internal%20Control%20Over%20Financial%20Reporting.) - **No changes** in internal control over financial reporting occurred during the three months ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, internal control over financial reporting[133](index=133&type=chunk) [Inherent Limitations on Effectiveness of Controls.](index=28&type=section&id=Inherent%20Limitations%20on%20Effectiveness%20of%20Controls.) - Management acknowledges that control systems provide only **reasonable, not absolute, assurance** and are subject to inherent limitations, including faulty judgments, errors, circumvention by individuals, and management override[134](index=134&type=chunk) [PART II – OTHER INFORMATION](index=30&type=section&id=PART%20II%20%E2%80%93%20OTHER%20INFORMATION) This part includes information on risk factors and a list of exhibits filed with the report [Item 1A. Risk Factors.](index=30&type=section&id=Item%201A.%20Risk%20Factors.) The company is exempt from this item's requirements due to its status as a Smaller Reporting Company - As a **Smaller Reporting Company**, Lantern Pharma Inc is exempt from the requirements of Item 1A[137](index=137&type=chunk) [Item 6. Exhibits.](index=30&type=section&id=Item%206.%20Exhibits.) This section lists all exhibits filed with the report, including by-law amendments, agreements, and officer certifications - Exhibit 3.4 is **Amendment No. 2 to By-Laws**, incorporated by reference from the Registrant's Current Report on Form 8-K filed July 29, 2025[138](index=138&type=chunk) - Exhibit 10.2 is the **ATM Sales Agreement**, dated July 3, 2025, by and between Lantern Pharma Inc and ThinkEquity LLC, incorporated by reference[138](index=138&type=chunk) - **Certifications of Principal Executive Officer and Principal Financial Officer** (Exhibits 31.1, 31.2, 32.1, 32.2) are filed or furnished electronically herewith[138](index=138&type=chunk) [SIGNATURES](index=32&type=section&id=SIGNATURES) The report is duly signed by the company's Chief Executive Officer and Chief Financial Officer - The report was signed on **August 13, 2025**, by Panna Sharma, Chief Executive Officer, and David R. Margrave, Chief Financial Officer, on behalf of Lantern Pharma Inc[141](index=141&type=chunk)[142](index=142&type=chunk)

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)