Lantern Pharma(LTRN) - 2024 Q1 - Quarterly Results

Introduction & Q1 2024 Business Highlights Lantern Pharma made significant progress in Q1 2024 across clinical trials, AI platform development, and strategic collaborations CEO Statement CEO Panna Sharma highlighted significant Q1 2024 progress in clinical trials and AI platform, emphasizing AI's role in transforming biopharma development and fostering collaborations - Lantern Pharma made meaningful progress across multiple clinical trials and in furthering its AI platform, advancing internal capabilities to support data-driven, precision oncology trials and accelerate cost-effective development of drug-conjugates[2] - The company is at the forefront of demonstrating how combining emerging AI technologies, cancer biology, biomarker expertise, and focused clinical operations can transform timelines and costs in biopharma development[2] - Growing interest in machine-learning enabled drug development and the RADR AI platform is energizing the team, with excitement for increased collaborations and streamlined development of high-value drug candidates[5] Key Business Highlights Q1 2024 featured active clinical trials for three AI-guided drug candidates, regulatory approvals, and advancement of LP-184 and LP-284, alongside subsidiary and AI module progress, and $38.4 million in cash - Active clinical trials are underway for three AI-guided drug candidates, with initial data and clinical readouts for LP-184 on-track for the second half of 2024[3] - Regulatory allowance was obtained to begin Phase 2 Harmonic™ clinical trial enrollment in Japan and Taiwan, targeting never-smokers with NSCLC, while enrollment continues in the US[3] - Phase 1 clinical trials for LP-184 and LP-284 are advancing with no dose-limiting toxicities observed in any patient cohorts to date[3] - Starlight Therapeutics, a wholly-owned subsidiary, advanced with the filing of a clinical trial protocol for the Phase 1B dose optimization and expansion cohort in recurrent IDH wild-type high-grade gliomas[3] - An AI-powered module for streamlining and guiding differentiated ADC development was advanced, expected to be instrumental for next-generation drug candidates[3] - An AI-driven collaboration was established with Oregon Therapeutics to leverage the RADR platform for future clinical development strategies of a novel cancer metabolism inhibitor[3] Key Financial Metric (Q1 2024) | Metric | Value (as of March 31, 2024) | | :---------------------------------------- | :--------------------------- | | Cash, cash equivalents, and marketable securities | ~$38.4 million | AI-Powered Pipeline Updates The company advanced its key AI-guided drug candidates, LP-184, LP-300, and LP-284, through various clinical trial stages and regulatory approvals LP-184 Clinical Development LP-184's Phase 1A trial advanced with five dosed cohorts and no dose-limiting toxicities, targeting DDR deficient tumors, with data readout expected soon and diagnostic test development underway - Five cohorts of patients (dose levels 1-5) have been enrolled and dosed in the ongoing Phase 1A clinical trial for LP-184, with no observed dose-limiting toxicities to date[6] - Enrollment for LP-184's Phase 1A trial is expected to be complete this summer, with data readout anticipated in late summer or early fall[6] - Efforts are focused on enrolling cancer patients with DDR (DNA damage repair) deficient tumors, as these have shown higher sensitivity to LP-184[6] - Dose optimization and expansion protocols (Supplement A and B) have been submitted to the FDA for LP-184 in non-CNS solid tumors (including TNBC with DDR alterations) and recurrent IDH wild-type high-grade gliomas (in collaboration with Starlight Therapeutics)[6] - Development of a PCR-based molecular diagnostic test has been initiated to identify cancer patients most likely to respond to LP-184 treatment[7] LP-184 Estimated Annual Global Market Potential | Indication | Estimated Annual Market Potential | | :----------- | :-------------------------------- | | CNS cancers | $4.5+ billion | | Solid tumors | $7.5+ billion | | Total | $12+ billion | LP-300 Clinical Development (Harmonic™ Trial) The Phase 2 Harmonic™ trial for LP-300 is actively enrolling in the US and received regulatory approval in Japan and Taiwan, aiming to accelerate data and foster Asian partnerships - The Harmonic™ trial is assessing LP-300 in combination with standard-of-care chemotherapy (carboplatin and pemetrexed) for LCINS (Lung Cancer In Never Smokers) patients with relapsed NSCLC[11] - Phase 2 Harmonic™ clinical trial sites in the US are continuing to screen and increase patient enrollment, with approval also received to proceed in Japan and Taiwan[12] - In Japan and Taiwan, one-third of all lung cancer diagnoses are made among never-smokers, improving LP-300's positioning for collaborative and co-development partnerships in Asian markets[10][12] LP-300 Estimated Annual Market Potential | Region | Estimated Annual Market Potential | | :----- | :-------------------------------- | | US | $1.5 billion | | Global | Over $2.6 billion | LP-284 Clinical Development LP-284's Phase 1a trial dosed initial cohorts without dose-limiting toxicities, with plans for Q2 site expansion and advancement to Phase 1b/2 by year-end, targeting DDR-deficient lymphomas and sarcomas - The initial two cohorts of patients have been dosed in LP-284's Phase 1a clinical trial, with no dose-limiting toxicities observed[12] - Lantern Pharma expects to open additional US sites for LP-284 throughout Q2 2024, with potential to advance to Phase 1b/2 by the close of 2024[12] - LP-284 has demonstrated nanomolar potency in preclinical studies across various NHL cancer subtypes (MCL, DHL) and certain sarcomas with DDR deficiencies, particularly those with compromised ATM gene function[12] - There is an urgent and unmet need for novel therapeutic options for MCL, DHL, and HGBL patients, nearly all of whom relapse from current standard-of-care agents[12] LP-284 Estimated Annual Market Potential (US & Europe) | Indication | Estimated Annual Market Potential | | :-------------- | :-------------------------------- | | MCL, DHL, HGBLs | Over $3+ billion | Platform & Subsidiary Development The company advanced its core AI platform, its CNS-focused subsidiary, and novel drug conjugate programs, expanding capabilities and strategic partnerships RADR® Platform Growth and Development The RADR® AI platform expanded its capabilities and data scope, securing a new collaboration with Oregon Therapeutics to optimize XCE853 development and planning further partnerships in 2024 - RADR® continues to advance in size, scope, and capabilities, progressing towards becoming a standard for AI-driven drug development in oncology for both early-stage development and later-stage patient biomarker and combination therapy identification[14] - An AI-driven collaboration was announced with Oregon Therapeutics to optimize the development of a protein disulfide isomerase (PDI) inhibitor drug candidate, XCE853, for various cancer indications[14] - The collaboration leverages RADR's AI-based capabilities, including over 200 machine learning algorithms, to uncover biomarkers, molecular correlates of efficacy, and define potential combination regimens for XCE853[14] - Lantern Pharma will receive equal IP co-ownership and drug development rights for newly discovered biomarkers, novel indications, and new pharmacological strategies for XCE853[14] - The scope of RADR®'s data has broadened to include additional classes of compounds like ADCs, and detailed chemical/biochemical features and drug-interaction data, with plans for more biopharma and technology partnerships in 2024[14] Starlight Therapeutics Starlight Therapeutics, focusing on CNS cancers, advanced STAR-001 with a Phase 1B protocol filing, hired a CMO, and anticipates Phase 1b/2 trials in H2 2024, targeting a $4.5 billion to $5+ billion USD market - Starlight Therapeutics, a wholly-owned subsidiary focused on CNS and brain cancers with STAR-001 (LP-184 for CNS indications), filed a clinical trial protocol for the Phase 1B dose optimization and expansion cohort in recurrent IDH wild-type high-grade gliomas[15] - Dr. Marc Chamberlain was hired as CMO in Q4 2023 to focus on Starlight's clinical trials, personnel development, and corporate development activity[17] - Starlight and Lantern expect to initiate Phase 1b/2 clinical trials for STAR-001 during the second half of 2024[17] STAR-001 Estimated Market Potential | Indication | Estimated Market Potential | | :------------------------------------------ | :------------------------- | | Adult and pediatric primary and secondary CNS cancers | $4.5 billion to $5+ billion USD | ADC & Drug Conjugate Programs Lantern Pharma advanced its cryptophycin-based ADC program, showing picomolar potency and an 80% cancer cell kill rate in preclinical studies, with IND development planned for 2024 and an AI module for ADC development progressing - Lantern, in collaboration with academic partners, advanced the development, synthesis, and preclinical proof-of-concept of a novel, highly potent, cryptophycin-based ADC (cpADC)[18] - The cpADC demonstrated picomolar potency in a wide range of solid tumors and produced an 80% cancer cell kill rate in preclinical work, outperforming other approved ADCs, including in medium and low HER-2 expression cancers[18] - Lantern expects to move towards IND development of its ADC program during 2024, focusing on select solid tumors unresponsive or refractory to current therapies[18] - An AI module for differentiated, machine-learning based ADC development, characterization, analysis, and bioactivity prediction is being advanced as an extension to RADR®, leveraging its data and biomarker insights[18] Additional Operational Highlights The company shared recent scientific findings through publications and presentations, and launched a new webinar series to engage with stakeholders Publications and Presentations Lantern Pharma published new research on LP-184's lethal activity in HR deficient cancer cells and presented LP-284 clinical trial data at the AACR 2024 Annual Meeting - A new publication in Cancer Research Communications showcased LP-184's lethal activity, inducing elevated DNA double-strand breaks in HR deficient (HRD) cancer cells, with up to 12-fold increased sensitivity observed with depletion of key HR components[19] - LP-184 demonstrated nanomolar potency in a diverse range of HRD cancer models[19] - New data and scientific findings for LP-284 and its ongoing clinical trial were presented at the American Association for Cancer Research (AACR) 2024 Annual Meeting[19] Webinar Series Launch Lantern Pharma launched 'Webinar Wednesdays,' an educational series providing updates on research, clinical trials, and AI efforts, with the first webinar focusing on LP-300 and the Harmonic trial - Lantern Pharma announced a new series of educational webinars titled 'Webinar Wednesdays' to provide updates on its research, clinical trials, and AI efforts[21] - The first webinar, held on April 24th, featured Dr. Joseph Treat discussing LP-300 and the Harmonic clinical trial focused on LCINS patients[21] First Quarter 2024 Financial Highlights The company reported its financial performance for Q1 2024, including changes in cash, operating expenses, net loss, and warrant exercises Balance Sheet Cash, cash equivalents, and marketable securities decreased to approximately $38.4 million as of March 31, 2024, reflecting a capital-efficient business model Cash, Cash Equivalents, and Marketable Securities | Metric | As of March 31, 2024 | As of December 31, 2023 | Change (QoQ) | | :---------------------------------------- | :------------------- | :---------------------- | :----------------- | | Cash, cash equivalents, and marketable securities | ~$38.4 million | ~$41.3 million | Down ~$2.9 million | - The quarterly cash burn rate continues to reflect Lantern Pharma's capital-efficient, collaborator-centered business model[22] Operating Expenses Research and development expenses increased to $4.3 million in Q1 2024 due to clinical trial activity, while general and administrative expenses slightly decreased to $1.5 million Operating Expenses (Q1 2024 vs. Q1 2023) | Expense Category | Q1 2024 | Q1 2023 | Change (YoY) | | :--------------- | :-------------- | :-------------- | :--------------- | | R&D Expenses | ~$4.3 million | ~$2.6 million | Up ~$1.7 million | | G&A Expenses | ~$1.5 million | ~$1.7 million | Down ~$0.2 million | - The increase in R&D expenses was largely driven by an increase in clinical trial activity and clinical trial site activations[23] Net Loss Net loss for Q1 2024 increased to approximately $5.4 million, or $0.51 per share, compared to $3.9 million, or $0.36 per share, in Q1 2023 Net Loss (Q1 2024 vs. Q1 2023) | Metric | Q1 2024 | Q1 2023 | Change (YoY) | | :--------------- | :-------------- | :-------------- | :--------------- | | Net Loss | ~$5.4 million | ~$3.9 million | Up ~$1.5 million | | Net Loss per Share | ~$0.51 | ~$0.36 | Up ~$0.15 | Warrant Exercises In Q1 2024, Lantern issued 20,132 shares from cashless warrant exercises and 17,481 shares for cash, leaving 81,496 warrants outstanding at a $16.55 weighted average exercise price - Lantern issued 20,132 shares of common stock in Q1 2024 from the cashless exercise of warrants to purchase 79,021 shares[25] - An additional 17,481 shares of common stock were issued in Q1 2024 for approximately $55,000 from the exercise of warrants for cash[25] - Following these exercises, 81,496 warrants remain outstanding to purchase Lantern common stock at a weighted average exercise price of $16.55 per share[25] Company Information This section provides an overview of Lantern Pharma's mission, its AI platform, and its commitment to transparent communication with investors About Lantern Pharma Lantern Pharma, an AI company, leverages its RADR® platform with 60 billion+ oncology data points to accelerate drug discovery, boasting a growing clinical pipeline and a $15 billion+ USD market potential - Lantern Pharma is an AI company transforming the cost, pace, and timeline of oncology drug discovery and development[28] - Its proprietary AI and machine learning (ML) platform, RADR®, leverages over 60 billion oncology-focused data points and a library of 200+ advanced ML algorithms[28] - Newly developed drug programs have advanced from initial AI insights to first-in-human clinical trials in 2-3 years, at approximately $1.0 - 2.5 million per program[28] - The company's lead development programs include a Phase 2 clinical program and multiple Phase 1 clinical trials[29] - Starlight Therapeutics, a wholly-owned subsidiary, focuses exclusively on the clinical execution of promising therapies for CNS and brain cancers[29] - The AI-driven pipeline of innovative product candidates is estimated to have a combined annual market potential of over $15 billion USD[29] Forward-Looking Statements This section outlines forward-looking statements concerning future events, financial performance, and drug development risks, cautioning investors against undue reliance and disclaiming update obligations - The press release contains forward-looking statements concerning future events, financial performance, the potential of the RADR platform, strategic plans, clinical trial timing, market estimates, and the development of drug candidates[33] - Important factors could cause actual results to differ materially from forward-looking statements, including risks related to research success, preclinical observations, licensing, clinical testing, FDA approval, and the commercialization of RADR®-based products[33] - Investors are cautioned not to place undue reliance on these statements, and the company disclaims any obligation to update them, except as required by law[33] Disclosure Channels Lantern Pharma disseminates material information through its website, press releases, SEC filings, and social media to ensure broad and non-exclusionary public distribution - Lantern Pharma disseminates material information to the public through its website, press releases, SEC filings, digital newsletters, and social media to achieve broad, non-exclusionary distribution[34] - Investors are encouraged to review information made public through these channels, as it could be deemed material[34]