Financial Performance - The company reported net losses of approximately $14.91 million for the nine months ended September 30, 2024, compared to $11.78 million for the same period in 2023, reflecting an increase in operating expenses [91]. - The total operating expenses for the nine months ended September 30, 2024, were approximately $16.32 million, compared to $13.00 million for the same period in 2023 [97]. - The company expects to continue incurring significant operating losses for several years as it advances clinical trials and seeks regulatory approvals for drug candidates [108]. - Net cash used in operating activities was approximately $13,841,000 for the nine months ended September 30, 2024, compared to $10,961,000 for the nine months ended September 30, 2023 [105]. - Interest income increased by approximately $83,000 from $498,000 for the nine months ended September 30, 2023, to $581,000 for the nine months ended September 30, 2024 [104]. Research and Development - Research and development expenses totaled approximately $11.86 million for the nine months ended September 30, 2024, up from $8.32 million in the same period of 2023, indicating a significant investment in drug development [94]. - Research and development expenses increased by approximately $3,535,000, or 42%, from $8,321,000 for the nine months ended September 30, 2023, to $11,856,000 for the nine months ended September 30, 2024 [103]. - Research and development expenses increased by approximately $1,507,000, or 68%, from $2,210,000 for the three months ended September 30, 2023, to $3,717,000 for the three months ended September 30, 2024 [99]. - The company has three lead drug candidates (LP-300, LP-184, and LP-284) currently in clinical phases, with LP-300 undergoing a targeted Phase 2 trial for advanced non-small cell lung cancer [86]. - The company formed a wholly-owned subsidiary, Starlight Therapeutics, in January 2023 to focus on CNS and brain cancer drug development, particularly for LP-184 [85]. - The ADC program is advancing with a research collaboration with Bielefeld University, focusing on developing ADCs utilizing cryptophycin, which has shown promising antitumor activity [87]. Funding and Capital - The company has not generated any revenue to date and has financed operations primarily through equity sales [91]. - The company anticipates needing substantial additional funding to complete clinical trials, which may dilute existing stockholders' ownership interests [110]. - The company raised capital historically through the issuance of equity securities [113]. Assets and Liquidity - As of September 30, 2024, total assets were approximately $30.3 million, with liquidity including approximately $28.1 million of cash, cash equivalents, and marketable securities [108]. - The company maintains significant cash and cash equivalents exceeding federally insured limits, with most balances above $250,000 guaranteed by the FDIC [113]. Currency and Inflation - Foreign currency gains were approximately $28,000 for the nine months ended September 30, 2024, compared to losses of approximately $130,000 for the nine months ended September 30, 2023 [114]. - The company does not expect the impact of foreign currency losses to be material in future periods [114]. - Inflation has not materially affected the company's results of operations during the reported periods, but it could have a greater impact in the future if current levels persist [115]. Internal Controls - The company's disclosure controls and procedures were evaluated as effective as of September 30, 2024 [118]. - There were no changes in internal control over financial reporting that materially affected the company during the three months ended September 30, 2024 [119]. - The company recognizes that inherent limitations in control systems may lead to undetected errors or fraud [120]. - The company does not participate in foreign currency hedging activities and does not have derivative financial instruments [114].

Clinical Trials and Drug Development - Lantern Pharma is advancing three AI-guided precision-oncology drug candidates in active Phase 1 and Phase 2 clinical trials[1]. - The Phase 2 LP-300 Harmonic™ Trial showed an 86% clinical benefit rate in the initial 7 patient cohort, with a 43% objective response rate and an average tumor size reduction of 51% in partial responders[2][10]. - LP-184 received Fast Track Designation from the FDA for glioblastoma, with plans for a Phase 1b/2 clinical trial targeted to begin in early 2025[3][14]. - The Harmonic™ trial is expanding to Japan and Taiwan, targeting a potential global market estimated at over $4 billion annually for never-smoker NSCLC[12]. - LP-284 is in Phase 1a clinical trials with no dose-limiting toxicities observed, targeting an estimated annual market potential of over $3 billion for MCL, DHL, and HGBL[16]. - Lantern's AI-driven pipeline is estimated to have a combined annual market potential of over $15 billion across multiple cancer indications[26]. - Lantern Pharma has not yet received FDA marketing approval for any of its product candidates, which poses a risk to future revenue generation[27]. - The company is actively seeking partnerships and collaborations to support its drug development efforts and maximize commercial potential[27]. - Lantern Pharma's strategic plans include advancing its antibody drug conjugate (ADC) development program, with specific timelines for clinical trials and patient enrollment yet to be established[27]. - Lantern Pharma's research and development efforts are aimed at streamlining the drug development process, but funding risks remain a concern for future clinical trials[27]. Financial Performance - As of September 30, 2024, Lantern Pharma reported approximately $28.1 million in cash, cash equivalents, and marketable securities, down from $41.3 million at the end of 2023[6][17]. - Research and development expenses for Q3 2024 were approximately $3.7 million, compared to $2.2 million in Q3 2023[18]. - The net loss for Q3 2024 was approximately $4.5 million, or $0.42 per share, compared to a net loss of approximately $3.2 million, or $0.29 per share, in Q3 2023[19]. Strategic Focus and Innovation - The company is focusing on building an efficient internal clinical operations team to manage ongoing clinical trial costs more effectively[21]. - Lantern Pharma's Q3 2024 earnings report highlights a significant focus on advancing its RADR platform for drug candidate identification and patient population targeting[27]. - The company emphasizes its commitment to leveraging artificial intelligence and machine learning to enhance oncology drug discovery and development processes[27]. - The company acknowledges potential market sizes and patient populations for its drug candidates, although specific estimates were not disclosed[27]. - The company has outlined its intention to provide regular updates through various channels, including its website and SEC filings, to ensure broad dissemination of material information[28]. - Lantern Pharma's forward-looking statements indicate a cautious approach to future performance, highlighting the uncertainties inherent in drug development[27]. - The company has a clear focus on transforming the pace, risk, and cost of oncology drug discovery through innovative technologies[27].

Second Quarter 2024 Operating & Financial Results Conference Call / Webinar NASDAQ :LTRN With additional focus on preliminary patient data and clinical readouts for Phase 2 LP-300 Harmonic Trial August 8th, 2024 4:30 PM Eastern Time Forward Looking Statements This presentation contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, among other ...

Financial Data and Key Metrics Changes - The company reported a net loss of approximately $4.96 million for Q2 2024, or $0.46 per share, compared to a net loss of approximately $4.75 million, or $0.44 per share, for Q2 2023 [20] - R&D expenses increased to approximately $3.9 million from approximately $3.6 million in Q2 2023, driven by increased clinical trial activity [21] - General and administrative expenses decreased slightly to approximately $1.5 million from approximately $1.6 million in Q2 2023 [21] - Cash position was approximately $33.3 million as of June 30, 2024, expected to provide a cash runway into at least Q3 2025 [22] Business Line Data and Key Metrics Changes - The company has three active clinical trials and an additional ADC-based preclinical program [6] - In the Phase II Harmonic Clinical Trial, a preliminary clinical benefit rate of 86% was observed in the lead-in patient cohort [7] - Over 40 patients have been dosed in the LP-184 and LP-284 clinical trials, with no dose-limiting toxicities reported [7][10] Market Data and Key Metrics Changes - The global annual market potential for LP-184's target indications is estimated to exceed $10 billion to $12 billion, with $4 billion to $5 billion in CNS cancers and $7 billion to $8 billion for other solid tumors [13] - The annual market potential for LP-284 is estimated to exceed $3 billion, particularly for patients with non-Hodgkin's lymphomas [14] Company Strategy and Development Direction - The company aims to leverage AI and machine learning to transform drug development costs and timelines, focusing on precision oncology therapies [6][19] - A strategic collaboration with Oregon Therapeutics was launched to optimize the development of a first-in-class drug candidate [8] - The company is advancing its wholly-owned subsidiary, Starlight Therapeutics, focused on CNS and brain cancers, with plans for Phase Ib and II trials [8][43] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing innovation in the drug pipeline and the potential for AI-driven insights to impact patient outcomes [47] - The company is considering filing for breakthrough therapy designation based on preliminary data from the Harmonic Trial [37] - Management highlighted the importance of durable responses and safety profiles in determining the success of their therapies [50][51] Other Important Information - The company launched a webinar series focusing on AI, oncology drug development, and collaborations with leading physicians and scientists [9][44] - The RADR AI platform has guided the rapid development of three AI-guided drugs into clinical trials [9] Q&A Session Summary Question: What kind of threshold is needed for LP-300 to merit breakthrough candidacy status? - Management indicated that seeing a clinical benefit rate of around two-thirds from a larger patient cohort would be encouraging for breakthrough designation [50][51] Question: How does the safety profile of LP-300 compare to other NSCLC treatments? - The safety profile of LP-300 was noted to be favorable, with no new toxicities reported, contrasting with typical discontinuation rates seen in other treatments [52][53] Question: What milestones will determine the success of collaborations with Oregon Therapeutics and others? - Success will be measured by the ability to generate collaborative IP and insights that lead to monetization and advancements in treatment options [55][57]

Financial Performance - The company reported net losses of approximately $10.4 million for the six months ended June 30, 2024, compared to $8.6 million for the same period in 2023, reflecting an increase in operating expenses [80]. - The total operating expenses for the six months ended June 30, 2024, were approximately $11.14 million, compared to $9.48 million for the same period in 2023, reflecting increased investment in clinical development [85]. - Net cash used in operating activities was approximately $8,259,000 for the six months ended June 30, 2024, compared to approximately $7,349,000 for the same period in 2023, indicating an increase in cash outflow [93]. - The company expects to incur significant and increasing operating losses for at least the next several years as it continues clinical trials and seeks regulatory approvals for its drug candidates [97]. - The company anticipates needing substantial additional funding to complete its clinical trials, which may lead to dilution of existing stockholders' interests [99]. Research and Development - Research and development expenses totaled $3.89 million for the three months ended June 30, 2024, compared to $3.56 million for the same period in 2023, indicating a continued investment in drug development [82]. - Research and development expenses increased by approximately $2,028,000, or 33%, from approximately $6,111,000 for the six months ended June 30, 2023, to approximately $8,140,000 for the six months ended June 30, 2024 [91]. - The company has three lead drug candidates (LP-300, LP-184, and LP-284) currently in clinical phases, with LP-300 undergoing a targeted phase 2 trial for advanced non-small cell lung cancer [76]. - The ADC program is advancing with a research collaboration with Bielefeld University in Germany, focusing on developing ADCs utilizing cryptophycin, which has shown promising antitumor activity [77]. - The company formed a wholly-owned subsidiary, Starlight Therapeutics, in January 2023 to focus on the clinical development of LP-184 for CNS and brain cancer indications [75]. - LP-100, another drug candidate, is being positioned for development in earlier lines of therapy after previously failing pivotal Phase 3 trials due to lack of biomarker-driven patient stratification [78]. Expenses and Cash Management - General and administrative expenses decreased by approximately $112,000, or 7%, from $1.63 million in Q2 2023 to $1.52 million in Q2 2024, primarily due to reductions in payroll and insurance expenses [86]. - General and administrative expenses decreased by approximately $364,000, or 11%, from approximately $3,365,000 for the six months ended June 30, 2023, to approximately $3,001,000 for the six months ended June 30, 2024 [90]. - Net cash used in investing activities decreased from approximately $1,418,000 for the six months ended June 30, 2023, to approximately $758,000 for the six months ended June 30, 2024 [94]. - As of June 30, 2024, total assets were approximately $35.6 million, with liquidity including approximately $33.3 million of cash, cash equivalents, and marketable securities [97]. - Lantern Pharma's cash and cash equivalents consist primarily of cash and money market funds, limiting exposure to market risk from interest rate changes [102]. Currency and Inflation - Foreign currency losses of approximately $51,000 were experienced for each of the six months ended June 30, 2024, and 2023, related to the Australian subsidiary [103]. - The company does not expect inflation to have a material effect on its results of operations during the periods presented, although it acknowledges potential future impacts [103]. - Inflation has not had a material effect on the company's results of operations during the periods presented, but could impact future results if it remains high [103]. - The company considers the risk of foreign currency losses to be manageable and not expected to be material in the future [103]. - The company does not participate in foreign currency hedging activities and does not have other derivative financial instruments [103]. Governance and Compliance - Management evaluated the effectiveness of disclosure controls and procedures as of June 30, 2024, concluding they are effective [106]. - There were no changes in internal control over financial reporting that materially affected the company during the three months ended June 30, 2024 [107]. - Lantern Pharma had no long-term debt outstanding as of June 30, 2024, and December 31, 2023 [101]. - The company maintains significant amounts of cash and cash equivalents at financial institutions that exceed federally insured limits [102]. - Lantern Pharma raised capital historically through the issuance of equity securities [101].

Clinical Trials and Drug Development - Active clinical trials are ongoing for three AI-guided drug candidates, with LP-300 showing an 86% clinical benefit rate in the initial 7 patient cohort of the Phase 2 Harmonic™ Trial[1][5] - The Phase 2 Harmonic™ trial is expected to expand into Japan and Taiwan, targeting a market potential of $1.5 billion in the US and over $2.6 billion globally for never-smokers with NSCLC[6][7] - The LP-184 Phase 1A clinical trial has enrolled seven cohorts with no dose-limiting toxicities observed, and the global market potential for its target indications is estimated at over $12 billion[8][9] - The LP-284 Phase 1A clinical trial is progressing with no dose-limiting toxicities, and the annual market potential for MCL, DHL, and HGBL is estimated at over $3 billion[10] - Lantern Pharma is advancing the development of its drug candidates and antibody drug conjugate (ADC) program, leveraging its RADR platform to identify promising drug candidates and patient populations[21] Financial Performance - As of June 30, 2024, the company reported approximately $33.3 million in cash, cash equivalents, and marketable securities, down from approximately $41.3 million at the end of 2023[2][15] - Research and development expenses for Q2 2024 were approximately $3.9 million, compared to $3.6 million in Q2 2023[2][15] - The net loss for Q2 2024 was approximately $4.96 million, or $0.46 per share, compared to a net loss of approximately $4.75 million, or $0.44 per share, in Q2 2023[2][15] - The combined annual market potential of the company's innovative product candidates is estimated to exceed $15 billion[20] Strategic Collaborations and Market Potential - The company launched a strategic collaboration with Oregon Therapeutics to develop the drug candidate XCE853, a potent inhibitor of cancer metabolism[2][13] - The company plans to maximize the commercial potential of its drug candidates through internal development and collaborations[21] - Lantern Pharma acknowledges the importance of its RADR AI platform in the context of its overall market strategy and potential market sizes[21] RADR Platform and AI Utilization - The RADR® platform is advancing towards becoming a standard for AI-driven drug development in oncology, focusing on drug sensitivity and biomarker data[12][13] - The company emphasizes the potential of its RADR platform to streamline drug development processes, aiming to reduce the pace, risk, and cost associated with oncology drug discovery[21] - The company is focused on utilizing artificial intelligence, machine learning, and genomic data to enhance its drug discovery efforts and identify responsive patient populations[21] Risks and Uncertainties - Lantern Pharma has not yet received FDA marketing approval for any of its product candidates, which poses a risk to its future financial performance[21] - Lantern Pharma's forward-looking statements highlight the uncertainty surrounding clinical trial outcomes and the potential for successful partnerships and collaborations[21] Investor Communication - The company encourages investors to review publicly available information to stay informed about its technologies and clinical developments[22] - Lantern Pharma's disclosures regarding material information are disseminated through various channels, including its website, press releases, and SEC filings[22] - The company’s strategic plans include advancing its internal drug discovery programs while managing the associated risks[21]

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 ...

Exhibit 99.1 Lantern Pharma Reports First Quarter 2024 Financial Results and Business Highlights Thursday, May 9, 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 first quarter 2024, ended March 31, 2024. "Our compa ...

Lantern Pharma Inc. (NASDAQ:LTRN) Q4 2023 Earnings Conference Call March 18, 2024 4:30 PM ET Company Participants Panna Sharma - President and Chief Executive Officer David Margrave - Chief Financial Officer Conference Call Participants Operator Good afternoon, and welcome to our Fourth Quarter and Year End 2023 Earnings Call. As a reminder, this call is being recorded and all attendees are in a listen-only mode. We will open the call for questions and answers after our management’s presentation. A webcast ...

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 ...