Lantern Pharma(LTRN) - 2025 Q2 - Quarterly Results

Q2 2025 Business and Financial Highlights 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 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] - 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] - 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] - 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] AI Platform Innovations 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] - 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] Financial Overview 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] - The company expects its existing capital to provide an operating runway at least into June 2026[9] Company Overview and CEO Statement 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 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] - 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] - 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] Operational Highlights 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 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 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] - 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] - 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] - Independent research at Johns Hopkins validated LP-184 data, demonstrating a 345% improvement in median survival in the CHLA06 mouse model of ATRT[15] LP-300 HARMONIC™ Trial Updates 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] - The Phase 2 HARMONIC™ trial completed enrollment of its Japanese cohort of 10 patients[18] - Additional clinical data and findings from the HARMONIC™ Phase 2 trial are anticipated in September 2025[4] - The market opportunity for the treatment of never-smokers with NSCLC is estimated at over $4 billion annually[20] LP-284 Program Updates 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] - This patient had previously failed standard R-CHOP/Pola-R-CHP chemotherapy, CAR-T cell therapy, and CD3xCD20 bispecific antibody therapy[22] - This represents the first complete response observed with LP-284, supporting its synthetic lethal mechanism and potential in treating refractory aggressive lymphomas[23] - 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] Intellectual Property Advancements 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] - This EU patent complements existing composition of matter patents granted in the U.S. (April 2023) and Japan (June 2024)[25] - 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] - The predictBBB™ technology demonstrates exceptional performance, processing up to 100,000 molecules per hour with industry-leading accuracy[26] RADR AI Platform Enhancements 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] - The PredictBBB.ai™ module was publicly launched, offering 94% prediction accuracy, 95% sensitivity, and 89% specificity for blood-brain barrier permeability[28] - 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] - This drug combination module targets a market opportunity where approximately $50 billion is spent annually on the development of combination therapies for cancer[29] - 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] Financial Results for Second Quarter 2025 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 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] - This compares to approximately $24.0 million as of December 31, 2024[31] - The company believes its existing capital will fund operating expenses and capital expenditure requirements at least into June 2026[31] Operating Expenses 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 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 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] - Options to purchase 1,239,766 shares of common stock were outstanding at a weighted average exercise price of $5.72 per share[34] - There were no outstanding warrants as of June 30, 2025[34] Earnings Call Decision 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] - The company plans to focus resources on other distribution channels like webinars, digital media resources, and broader social media channels for stockholder communication[35] Condensed Consolidated Financial Statements 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 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 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 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 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] - 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] - 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] Forward-Looking Statements 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 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] - 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] - 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] Disclosure Channels to Disseminate Information 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 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] - These channels are used to achieve broad, non-exclusionary distribution of information to the public[44] - Investors are encouraged to review the information made public in these locations as it could be deemed material[44] Contacts This section provides contact information for investor relations inquiries Investor Relations Contact For investor relations inquiries, contact Lantern Pharma's Investor Relations team via email - Investor Relations Contact: ir@lanternpharma.com[45]