UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Lantern Pharma Inc. (Exact name of registrant as specified in its charter) | Delaware | 001-39318 | 46-3973463 | | --- | --- | --- | | (State or Other Jurisdiction | (Commission | (IRS Empl ...

[Introduction & Q1 2024 Business Highlights](index=1&type=section&id=Introduction%20%26%20Q1%202024%20Business%20Highlights) Lantern Pharma made significant progress in Q1 2024 across clinical trials, AI platform development, and strategic collaborations [CEO Statement](index=1&type=section&id=CEO%20Statement) 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](index=2&type=chunk) - 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](index=2&type=chunk) - 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](index=5&type=chunk) [Key Business Highlights](index=1&type=section&id=Key%20Business%20Highlights) 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](index=3&type=chunk) - 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](index=3&type=chunk) - 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](index=3&type=chunk) - 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](index=3&type=chunk) - An AI-powered module for streamlining and guiding differentiated ADC development was advanced, expected to be instrumental for next-generation drug candidates[3](index=3&type=chunk) - 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](index=3&type=chunk) 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](index=2&type=section&id=AI-Powered%20Pipeline%20Updates) 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](index=2&type=section&id=LP-184%20Clinical%20Development) 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](index=6&type=chunk) - 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](index=6&type=chunk) - Efforts are focused on enrolling cancer patients with DDR (DNA damage repair) deficient tumors, as these have shown higher sensitivity to LP-184[6](index=6&type=chunk) - 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](index=6&type=chunk) - Development of a PCR-based molecular diagnostic test has been initiated to identify cancer patients most likely to respond to LP-184 treatment[7](index=7&type=chunk) 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)](index=3&type=section&id=LP-300%20Clinical%20Development%20(Harmonic%E2%84%A2%20Trial)) 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](index=11&type=chunk) - 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](index=12&type=chunk) - 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](index=10&type=chunk)[12](index=12&type=chunk) LP-300 Estimated Annual Market Potential | Region | Estimated Annual Market Potential | | :----- | :-------------------------------- | | US | $1.5 billion | | Global | Over $2.6 billion | [LP-284 Clinical Development](index=3&type=section&id=LP-284%20Clinical%20Development) 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](index=12&type=chunk) - 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](index=12&type=chunk) - 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](index=12&type=chunk) - 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](index=12&type=chunk) LP-284 Estimated Annual Market Potential (US & Europe) | Indication | Estimated Annual Market Potential | | :-------------- | :-------------------------------- | | MCL, DHL, HGBLs | Over $3+ billion | [Platform & Subsidiary Development](index=4&type=section&id=Platform%20%26%20Subsidiary%20Development) 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](index=4&type=section&id=RADR%C2%AE%20Platform%20Growth%20and%20Development) 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](index=14&type=chunk) - 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](index=14&type=chunk) - 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](index=14&type=chunk) - 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](index=14&type=chunk) - 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](index=14&type=chunk) [Starlight Therapeutics](index=4&type=section&id=Starlight%20Therapeutics) 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](index=15&type=chunk) - Dr. Marc Chamberlain was hired as CMO in Q4 2023 to focus on Starlight's clinical trials, personnel development, and corporate development activity[17](index=17&type=chunk) - Starlight and Lantern expect to initiate Phase 1b/2 clinical trials for STAR-001 during the second half of 2024[17](index=17&type=chunk) 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](index=5&type=section&id=ADC%20%26%20Drug%20Conjugate%20Programs) 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](index=18&type=chunk) - 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](index=18&type=chunk) - 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](index=18&type=chunk) - 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](index=18&type=chunk) [Additional Operational Highlights](index=5&type=section&id=Additional%20Operational%20Highlights) The company shared recent scientific findings through publications and presentations, and launched a new webinar series to engage with stakeholders [Publications and Presentations](index=5&type=section&id=Publications%20and%20Presentations) 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](index=19&type=chunk) - LP-184 demonstrated nanomolar potency in a diverse range of HRD cancer models[19](index=19&type=chunk) - 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](index=19&type=chunk) [Webinar Series Launch](index=6&type=section&id=Webinar%20Series%20Launch) 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](index=21&type=chunk) - The first webinar, held on April 24th, featured Dr. Joseph Treat discussing LP-300 and the Harmonic clinical trial focused on LCINS patients[21](index=21&type=chunk) [First Quarter 2024 Financial Highlights](index=6&type=section&id=First%20Quarter%202024%20Financial%20Highlights) The company reported its financial performance for Q1 2024, including changes in cash, operating expenses, net loss, and warrant exercises [Balance Sheet](index=6&type=section&id=Balance%20Sheet) 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](index=22&type=chunk) [Operating Expenses](index=6&type=section&id=Operating%20Expenses) 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](index=23&type=chunk) [Net Loss](index=6&type=section&id=Net%20Loss) 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](index=6&type=section&id=Warrant%20Exercises) 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](index=25&type=chunk) - 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](index=25&type=chunk) - 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](index=25&type=chunk) [Company Information](index=7&type=section&id=Company%20Information) This section provides an overview of Lantern Pharma's mission, its AI platform, and its commitment to transparent communication with investors [About Lantern Pharma](index=7&type=section&id=About%20Lantern%20Pharma) 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](index=28&type=chunk) - 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](index=28&type=chunk) - 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](index=28&type=chunk) - The company's lead development programs include a Phase 2 clinical program and multiple Phase 1 clinical trials[29](index=29&type=chunk) - Starlight Therapeutics, a wholly-owned subsidiary, focuses exclusively on the clinical execution of promising therapies for CNS and brain cancers[29](index=29&type=chunk) - The AI-driven pipeline of innovative product candidates is estimated to have a combined annual market potential of over **$15 billion USD**[29](index=29&type=chunk) [Forward-Looking Statements](index=8&type=section&id=Forward-Looking%20Statements) 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](index=33&type=chunk) - 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](index=33&type=chunk) - 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](index=33&type=chunk) [Disclosure Channels](index=8&type=section&id=Disclosure%20Channels) 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](index=34&type=chunk) - Investors are encouraged to review information made public through these channels, as it could be deemed material[34](index=34&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Lantern Pharma Inc. (Exact name of registrant as specified in its charter) | Delaware | 001-39318 | 46-3973463 | | --- | --- | --- | | (State or Other Jurisdiction | (Commission | (IRS Employer ...

Exhibit 99.1 Lantern Pharma Reports Fourth Quarter & Fiscal Year 2023 Financial Results and Business Highlights Monday, March 18, 2024 DALLAS—(Business Wire)—Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence ("AI") company developing targeted and transformative cancer therapies using its proprietary RADR AI and machine learning ("ML") platform with multiple clinical-stage drug programs, today announced operational highlights and financial results for the fourth quarter and fiscal year ended Dec ...

Financial Data and Key Metrics Changes - The net loss for Q3 2023 was approximately $3.2 million or $0.29 per share, compared to a net loss of approximately $2.3 million or $0.21 per share for Q3 2022 [39] - General and administrative expenses were approximately $1.3 million for Q3 2023, down from approximately $1.4 million in the prior year [38] - R&D expenses increased to approximately $2.2 million for Q3 2023, up from approximately $0.7 million in Q3 2022 [38] Business Line Data and Key Metrics Changes - The company received FDA clearance for its IND application for LP-284, initiating a first-in-human clinical trial for refractory non-Hodgkin's lymphomas and sarcomas [9] - The first patient was dosed in the Phase I trial for LP-184, which targets multiple advanced solid tumors [18] - The company plans to share broader data on its novel cryptophycin-based antibody drug conjugate in January 2024 [10] Market Data and Key Metrics Changes - The estimated annual market potential for LP-284 is between $3 billion to $4 billion, targeting advanced non-Hodgkin's lymphoma cancer subtypes [44] - The global aggregate annual market potential for LP-184 is in excess of $11 billion, with significant portions for CNS cancers and solid tumors [49] - The company is expanding its trials into East Asian countries, where the demographic for non-small cell lung cancer patients is significantly higher than in the U.S. [18] Company Strategy and Development Direction - The company is focused on transforming oncology drug discovery and development through AI-driven approaches, aiming to reduce costs and timelines [4][6] - The RADR AI platform is being advanced to predict patient responses and identify optimal combination regimens for immuno-oncology drugs [32] - The establishment of Starlight Therapeutics aims to focus on CNS and neuro-oncology, with plans for a Phase II trial for multiple indications [57][86] Management's Comments on Operating Environment and Future Outlook - Management emphasized the need for the industry to rethink its approach to drug pricing and availability, suggesting that AI adoption will be crucial [35] - The company believes it is well-positioned to lead in the transformation of cancer medicine through its innovative AI platform [33] - The cash position of approximately $44.9 million is expected to provide a runway into at least Q3 2025, supporting ongoing development efforts [20][37] Other Important Information - The company has successfully developed and launched 11 additional programs in the past two years, showcasing its efficiency and agility [34] - The RADR platform has surpassed 36 billion oncology-focused data points, with projections to exceed 50 billion by the end of the year [53] - Lantern Pharma has a strong patent position with claims extending into the 2030s for its lead product candidates [87] Q&A Session Summary Question: What will guide efforts to narrow down indications for LP-184 after Phase I? - The company will conduct extensive biomarker work and analyze responses across various solid tumors, utilizing data from FFPE slides and liquid biopsies [79] Question: When can initial data from Harmonic Phase I studies for LP-184 and LP-284 be expected? - Initial data is anticipated in the first half of next year, with a focus on reaching 27 events by the end of the year for more substantial data [80] Question: What is the timeline for the ADC program? - The company expects to share data in January and anticipates filing an IND application in early 2024 or early 2025 [81] Question: What is the goal for Starlight Therapeutics? - The goal is to focus on CNS cancers, with plans to raise funding in Q1 2024 and launch a Phase II trial for multiple indications in Q2 or Q3 [86] Question: What are the expectations for RADR data accumulation in 2024? - The company anticipates significant growth, potentially doubling the data points to reach between 100 billion to 200 billion [89]

November 8th, 2023 4:30 PM Eastern Time r m a 1 > Lantern P h a r m a | --- | --- | --- | --- | --- | --- | |--------------------------|-------|--------------------------------|-------|----------------|-------| | | | | | | | | Contents | | Speakers | | | | | 01 Introduction | | Panna Sharma CEO and President | CFO | David Margrave | | | 02 Q3 2023 Highlights | | | | | | | 03 Financial Highlights | | | | | | | 04 Q&A | | | | | | (*Parker et al., 2021) RADR® can predict and stratify real-world patients for cl ...

Financial Performance - The company reported net losses of approximately $11,776,000 for the nine months ended September 30, 2023, compared to $10,879,000 for the same period in 2022, indicating an increase in losses year-over-year [88]. - Net losses were approximately $11,776,000 for the nine months ended September 30, 2023, compared to $10,879,000 for the same period in 2022 [105]. - Net cash used in operating activities was approximately $10,961,000 for the nine months ended September 30, 2023, compared to approximately $10,099,000 for the same period in 2022 [110]. - The company experienced foreign currency losses of approximately $130,000 for the nine months ended September 30, 2023, compared to $159,000 for the same period in 2022 [120]. - Cash and cash equivalents decreased from approximately $37,202,000 as of December 31, 2022, to approximately $25,572,000 as of September 30, 2023 [108]. Research and Development - Research and development expenses increased by approximately $1,508,000, or 215%, from $702,000 for the three months ended September 30, 2022, to $2,210,000 for the same period in 2023 [99]. - Research and development expenses increased approximately $1,970,000, or 31%, from approximately $6,351,000 for the nine months ended September 30, 2022, to approximately $8,321,000 for the nine months ended September 30, 2023 [103]. - The company is advancing three lead drug candidates and an Antibody Drug Conjugate (ADC) program, all leveraging precision oncology and AI-driven approaches [83]. - LP-300 is currently undergoing a targeted phase II trial for non-small cell lung cancer (NSCLC) in never smoking patients, while LP-100 has shown a median overall survival of approximately 12.5 months in a previous trial [85]. - The ADC program is in preclinical research optimization, with a focus on identifying targeted antibodies for selected compounds [83]. Operating Expenses - The total operating expenses for the nine months ended September 30, 2023, were $13,000,186, compared to $10,606,475 for the same period in 2022 [97]. - General and administrative expenses decreased by approximately $129,000, or 9%, from $1,443,000 for the three months ended September 30, 2022, to $1,314,000 for the same period in 2023 [98]. - General and administrative expenses increased approximately $424,000, or 10%, from approximately $4,255,000 for the nine months ended September 30, 2022, to approximately $4,679,000 for the nine months ended September 30, 2023 [102]. - The company expects to incur significant expenses as it continues to develop its pipeline and build the necessary infrastructure for commercialization [90]. - The company expects to incur significant and increasing operating losses as it continues clinical trials for its drug candidates [113]. Revenue Generation - The company has not generated any revenue to date, relying primarily on equity securities sales to finance operations [88]. Funding and Financial Strategy - The company plans to apply for grant funding in the future to support its capital needs [107]. - The company had no long-term debt outstanding as of September 30, 2023 [118]. Interest Income - Interest income increased approximately $368,000, or 283%, from approximately $130,000 for the nine months ended September 30, 2022, to approximately $498,000 for the nine months ended September 30, 2023 [104].

Financial Data and Key Metrics Changes - The company recorded a net loss of approximately $4.7 million for Q2 2023, or $0.44 per share, compared to a net loss of approximately $4.5 million, or $0.41 per share, for Q2 2022 [60] - R&D expenses increased to approximately $3.6 million in Q2 2023 from approximately $3.0 million in Q2 2022, driven by increases in research studies and payroll expenses [14] - The company maintained a strong cash position with approximately $48 million in cash, cash equivalents, and marketable securities as of June 30, 2023, providing a runway into 2025 [30][61] Business Line Data and Key Metrics Changes - The company has over 14 drug programs, many with orphan drug designations, addressing markets estimated at approximately $14 billion in annual therapy sales [5] - The RADR platform has enabled a 70% reduction in early-stage drug development timelines and an 80% reduction in costs compared to traditional methods [6] - The AI-driven pipeline includes LP-184 and LP-284, which are part of the synthetic lethality franchise showing significant potency in various cancers [37][38] Market Data and Key Metrics Changes - The global market for antibody-drug conjugates (ADCs) is projected to grow from $4 billion to over $14 billion by 2027, indicating significant growth potential in this segment [28][70] - The market for mantle cell lymphoma and double-hit lymphomas is estimated at $1.2 billion in the U.S. and Europe, with a global potential of 2 to 2.5 times that amount [65] Company Strategy and Development Direction - The company aims to leverage AI and machine learning to transform oncology drug discovery, focusing on targeted therapies and reducing costs and timelines [4][46] - A partnership with Bielefeld University in Germany is set to develop next-generation ADCs, enhancing the company's capabilities in this rapidly growing market [27][69] - The company plans to actively explore licensing and partnership opportunities with biopharma companies to accelerate the path to patients for its therapies [47] Management's Comments on Operating Environment and Future Outlook - Management highlighted the need for the industry to rethink its approach to drug pricing and development, emphasizing the role of AI in addressing these challenges [7] - The company is optimistic about the potential of its drug candidates, particularly LP-184, which has an estimated global market potential exceeding $10 billion [63] - The focus for the second half of the year will be on advancing enrollment in clinical trials for LP-184 and LP-300, with expectations for significant progress [46][68] Other Important Information - The company received FDA clearance for its IND application for LP-184 in June 2023, marking a significant milestone for the program [34] - The RADR platform's predictive accuracy is reported at 88% in identifying patients likely to respond to drugs in clinical trials [25] - The company has filed five new patent applications for LP-184 and LP-284, extending commercial protection for these assets [58] Q&A Session Summary Question: Has the first stage of the Harmonic trial enrolled yet? - Yes, the first stage of the trial is in progress, and results will be reported as they are reviewed [79] Question: How will genomic and transcriptomic data from the Harmonic trial guide future trials? - The data from liquid biopsies will help identify specific patient signatures that may respond better to therapies [80] Question: What is the biological difference between genders in the study? - The trial reflects the real-world epidemiology of lung cancer, where a higher proportion of never smokers diagnosed are female [97] Question: Is there preclinical data supporting the combination of pembrolizumab with LP-300? - Currently, there is no specific preclinical data, but the combination may enhance treatment efficacy based on feedback from clinicians [89] Question: How does Lantern Pharma compare to other AI-driven companies in drug discovery? - Lantern's focused approach in oncology and its integration of biology with AI distinguishes it from other companies that may lack direction [92]

Second Quarter 2023 Operating & Financial Results Conference Call / Webinar NASDAQ: LTRN 1 Nasdaq: LTRN RADR® can predict and stratify real-world patients for clinical trials with 88% Accuracy LANTERN'S DRUG DEVELOPMENT MODEL AND OBJECTIVES Accelerated timelines; reduced costs and risks Lantern's diverse & unique AI-driven pipeline of 14 drug programs includes the Phase 2 Harmonic™ trial and RADR® collaborations August 9th, 2023 4:30 PM Eastern Time Forward Looking Statements > Lantern P h a r m a Lantern i ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Lantern Pharma Inc. (Exact name of registrant as specified in its charter) | Delaware | 001-39318 | 46-3973463 | | --- | --- | --- | | (State or Other Jurisdiction | (Commission | (IRS Emplo ...