Lantern Pharma September 8, 2023
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Lantern Pharma's presentation outlines their forward-looking statements regarding their AI platform, radr®, which aims to enhance cancer drug discovery and development by improving the efficiency and cost-effectiveness of clinical trials. The company highlights their current drug candidates, clinical trials in progress, and the impact of AI on predicting patient responses and clinical outcomes. Lantern has several ongoing collaborations and aims to leverage its technology to transform oncology treatment options while addressing the risks and uncertainties associated with their drug development.
Lantern Pharma September 8, 2023
- 1. Corporate Overview September 8th, 2023 NASDAQ: LTRN
- 2. Forward Looking Statements 2 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 things, statements relating to: future events or our future financial performance; the potential advantages of our RADR® platform in identifying drug candidates and patient populations that are likely to respond to a drug candidate; our strategic plans to advance the development of our drug candidates and antibody drug conjugate (ADC) development program; estimates regarding the development timing for our drug candidates and ADC development program; expectations and estimates regarding clinical trial timing and patient enrollment; our research and development efforts of our internal drug discovery programs and the utilization of our RADR® platform to streamline the drug development process; our intention to leverage artificial intelligence, machine learning and biomarker data to streamline and transform the pace, risk and cost of oncology drug discovery and development and to identify patient populations that would likely respond to a drug candidate; estimates regarding patient populations, potential markets and potential market sizes; sales estimates for our drug candidates and our plans to discover and develop drug candidates and to maximize their commercial potential by advancing such drug candidates ourselves or in collaboration with others. Any statements that are not statements of historical fact (including, without limitation, statements that use words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “model,” “objective,” “aim,” “upcoming,” “should,” “will,” “would,” or the negative of these words or other similar expressions) should be considered forward-looking statements. There are a number of important factors that could cause our actual results to differ materially from those indicated by the forward-looking statements, such as (i) the risk that our research and the research of our collaborators may not be successful, (ii) the risk that none of our product candidates has received FDA marketing approval, and we may not be able to successfully initiate, conduct, or conclude clinical testing for or obtain marketing approval for our product candidates, (iii) the risk that no drug product based on our proprietary RADR® AI platform has received FDA marketing approval or otherwise been incorporated into a commercial product, and (iv) those other factors set forth in the Risk Factors section in our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission on March 20, 2023. You may access our Annual Report on Form 10-K for the year ended December 31, 2022 under the investor SEC filings tab of our website at www.lanternpharma.com or on the SEC’s website at www.sec.gov. Given these risks and uncertainties, we can give no assurances that our forward-looking statements will prove to be accurate, or that any other results or events projected or contemplated by our forward-looking statements will in fact occur, and we caution investors not to place undue reliance on these statements. All forward-looking statements in this presentation represent our judgment as of the date hereof, and, except as otherwise required by law, we disclaim any obligation to update any forward-looking statements to conform the statement to actual results or changes in our expectations. Nasdaq: LTRN
- 3. Lantern’s AI platform, RADR®, is transforming the cost, pace, and timeline of cancer drug discovery and development * Includes drug programs being developed in collaboration ** at 6/30/2023 95+ 14 $48.0M Drug programs* powered by AI Issued patents & pending applications Cash/cash eq./ marketable securities 5 Clinical stage drug candidates* 2.5 years Avg. time for new LTRN programs to Ph. 1 Trial $1.5M Avg. cost for new LTRN programs to Ph. 1 Trial 3 **
- 4. 4 Only 6% of clinical trials using traditional drug discovery approaches succeed * *Clinical Development Success Rates and Contributing Factors 2011–2020, BIO Stats Current Challenges Average cost to bring a new cancer drug to market is $2.8 billion Out of 20,000 trials from 2012-2022, 19,200 trials failed Costly Risky Slow Early-Stage development takes 3-5+ Years, late-stage development takes 6-12+ Years Current oncology drug development is being improved by data-driven, and AI-enabled approaches and technology
- 5. Lantern is Transforming Drug Discovery Timelines & Costs with AI AI insights and biomarkers can increase the odds of clinical trial success by 12X* RADR® can predict and stratify real-world patients for clinical trials with 88% accuracy Lantern can compress the timeline of early-stage drug development by 70% and reduce the cost by 80% Lantern has launched 10 new programs in 2 years, and has active ongoing ph.1 and ph.2 clinical trials LANTERN’S DRUG DEVELOPMENT MODEL AND OBJECTIVES Large Scale/Multi-omics Oncology Data Proprietary AI platform RADR® Accelerated timelines; reduced costs and risks (*Parker et al., 2021) 5
- 6. Lantern’s AI-Driven Business Model has Multiple Routes Towards Success High-value Partnering & Licensing Opportunities Rescue & Reposition Drug Candidates Discover & Develop New Molecules Including ADCs Accelerate & De-risk Trials with Biopharma Partners AI Platform 6 Based on previous clinical data and observations, LP-300 was rescued for never smokers with NSCLC and is in a Phase 2 trial LP-284’s unique mechanism of action was predicted by RADR® and was developed to Phase 1 trial in 2 years Predicting patient response with greater than 88% accuracy, Lantern is accelerating the development of Elraglusib 1 2 3 Successes to Date Areas of Focus Targeted Clinical Trials By Lantern and/or other biopharma partners
- 7. Response Algorithm for Drug Positioning & Rescue A proprietary integrated data analytics, experimental biology, oncology- focused, machine-learning-based platform focused on drug development 80%+ Prediction Success Patient Records 130K+ Data Sets 8,163+ Advanced ML Algorithms 200+ 34+ Billion Today 50+ Billion By the end of 2023 Data points from oncology focused real-world patient and clinical data and preclinical studies AI-Powered RADR® Modules for Oncology Drug Discovery and Development 7 Discover mechanism of action of any compound or drug Determine optimal drug combos to improve therapeutic potential Generate ML-driven biomarker signatures for patient selection Characterize specialized attributes of a molecule such as BBB permeability Identify/prioritize a compound’s disease indications or subtypes Enhance the selection of optimal combination of ADC components m1 m2 m3 m4 m5 m6 Discover drug combos for checkpoint inhibitors to improve therapeutic index m7
- 8. Lantern Pharma is a Top 10 End-to-End AI Drug Discovery Company NASDAQ: LTRN 8 According to Deep Pharma Intelligence (May 04, 2022)
- 9. NASDAQ: LTRN Ensemble Deep Learning Bayesian Based Tree Based Rule Based Clustering Others 200+ AI Algorithms Clinical Trials In vitro/ In vivo Studies Genetic Screens/Panels Chemical Structure Collaborator Studies Multi-Omics Public/Private Repositories Drug Response Datatypes/Sources RADR®‘s AI Framework RADR®‘s AI framework develops actionable insights using billions of datapoints 9 MoA Discovery Drug Combination Optimization Biomarker Signature Generation Molecule attribute Characterization Disease Indication Identification ADC Development RADR AI insights m1 m2 m3 m4 m5 m6 RADR® Modules (m) Immune Checkpoint Inhibitor Development m7
- 10. NASDAQ: LTRN RADR® Case Study – Actuate Therapeutics Advanced RADR® machine learning models predict clinical trial patient responses at 88% accuracy Lantern is accelerating the development of Actuate Therapeutic’s drug candidate, Elraglusib* (9-ING-41), using AI insights produced by RADR® • Predicted patient response with greater than 88% accuracy • Identified metastatic melanoma patients resistant to PD-1 therapies may benefit from Elraglusib • Insights and new data including RNA, ctDNA, and protein biomarkers are informing design of an upcoming Phase 2 clinical trial • Lantern received equity in Actuate as part of the collaboration *elraglusib is a widely researched GSK-3β inhibitor. Currently, elraglusib is in multiple active Phase I/II clinical trials as a monotherapy and in combination with other agents (NCT03678883) x Posters: Model generation for patient response prediction 10
- 11. SCALE 1 Bn 8 Bn * 15 Bn 25 Bn 34 Bn 2020 2021 2022 Q1 2023 Q2 2023 End of year 2023* 50 billion oncology- focused datapoints by end of 2023 SCOPE CAPABILITIES • Additional classes of compounds including antibodies, checkpoint inhibitors, DNA damaging agents, and ADCs • BBB permeability prediction • Immune checkpoint inhibitor prediction • Next-generation ADCs development IO drugs ADCs DNA damaging agents * Based on current operational and development plans BBB Checkpoint Inhibitors ADC Design RADR® Road Map – Expansion of Size, Scope, and Capabilities RADR® continues to push the boundary of AI for oncology drug discovery and development 11
- 12. NASDAQ: LTRN 12 Collaborations Strategic collaborations that are providing unique real-world insights and accelerating timelines Biopharma Collaborations World-Class Academic and Research Institutions
- 13. Lantern’s Diverse & Unique AI Driven Pipeline of Drug Programs NASDAQ: LTRN 13 Lantern has 14 disclosed and collaborative drug programs including the Phase 2 Harmonic™ trial owned by – Actuate Therapeutics owned by– TTC Oncology Orphan Designation Rare Pediatric Disease Collaboration partner Lantern Pharma (NASDAQ: LTRN) Starlight Therapeutics (Wholly Owned Subsidiary) RADR® Collaborations Collaboration partner * for Pancreatic *for Mantle Cell Collaboration partner Elraglusib Multiple Solid Tumors TTC-352 ER+ Breast Cancers ADC Cryptophycin Conjugate for Solid Tumors STAR-001 (LP-184 for CNS and Brain Cancers Only) Glioblastoma (GBM) Brain Mets (Lung, Breast, Skin) Atypical Teratoid Rhabdoid Tumor (ATRT) Pediatric Brain Cancers Program Indication Discovery Preclinical Phase I Phase II LP-300 Non-Small Cell Lung Cancer for Never Smokers LP-100 Homologous Repair Deficient Cancers LP-184 Recurrent Advanced Solid Tumors (Pancreatic, TNBC, Bladder, Lung Cancers) LP-284 Recurrent Non-Hodgkin’s Lymphomas (Mantle cell, Double-hit lymphomas) ADC Select Solid Tumors
- 14. LP-300 for the Treatment of Non-Small Cell Lung Cancer (NSCLC) in Never Smokers Lead Indication Relapsed NSCLC for Never Smokers Clinical Status Phase 2 (initial patients dosed) Market Potential* $1.3 billion (USD) Indication Size* 20,000-40,000 Cases Target/ MOA Tyrosine Kinases & Cell Redox Enzymes Molecule Type Disulfide Small Molecule Combination With carboplatin and pemetrexed IP Estate Claims extending to at least 2032 *Estimated Annual US
- 15. Disease Overview – NSCLC in Never Smokers – LP-300 NASDAQ: LTRN 15 NSCLC in never smokers is one of the largest unaddressed cancer populations NSCLC in Never Smokers is a Different Disease Lung Cancer in never smokers has higher percentage of genetic mutations in Tyrosine Kinases (TK), a family of cancer-promoting genes, such as EGFR, ALK, ROS and MET Global Annual Market Potential: $2.5+ Billion In the US
- 16. Mechanism of Action – LP-300 NASDAQ: LTRN 16 LP-300’s multimodal MoA resensitizes NSCLC to chemo in the never smoker population LP-300 Modulates Cellular Redox in Key Signaling Pathways in NSCLC • Restoring apoptosis sensitivity • Oxidative stress modulation • Anti-angiogenesis • Reduced DNA synthesis and gene expression • Reduce glutathione/thioredoxin mediated tumor resistance to therapy • Nephrotoxicity protection against chemotherapy A-B. LP-300 adduct at Cys1235 Cys1156 C. Molecular surface of ALK with the LP-300-derived adduct at Cys1156 (yellow highlight) D. Binding site of the LP-300-derived adduct at Cys 1235 (yellow highlight) LP-300 Directly Engages with TKI Receptors via Cysteine Modification A. B. D. C. 1. 2.
- 17. 17 Clinicaltrials.gov (NCT00966914) NASDAQ: LTRN LP-300 Nearly Doubled Survival Outcomes for Never Smoker Subgroups with NSCLC in Previous Clinical Trial* 25% 32% 30% 72% 0% 20% 40% 60% 80% All Patients (n=288) Never Smokers (n=87) Median 2 year survival (%) control LP-300 + Chemo 11.7 13.2 15.4 25.2 0 10 20 30 All Patients (n=288) Never Smokers (n=87) Median overall survival (Mohths) control LP-300 + Chemo + 125% increase in median 2 year survival + 91% increase in median overall survival *Subpopulations receiving paclitaxel/cisplatin *Overall study did not meet clinical efficacy endpoints
- 18. 18 • Dr. Joseph Treat, MD of Fox Chase Cancer Center: appointed lead principal investigator for the Harmonic™ study • Initial patients dosed in first half of 2023, enrollment anticipated to last 18-24 months • Multiple additional patients and sites across the US anticipated to be enrolled during second half of 2023 • Exploring clinical trial expansion to Asian countries with a higher incidence of NSCLC in never smokers Nasdaq: LTRN Trial Updates Clinical Trial – The Harmonic™ Phase 2 Trial for LP-300 Accelerating recruitment efforts for a growing indication with limited treatment options Patients will receive LP-300 with pemetrexed and carboplatin* Patients will receive standard of care (pemetrexed and carboplatin) Trial Design Primary Outcomes: Overall and progression free survival 1st patient Estimated Interim Results Q1 2023 Enrollment anticipated to last 15 - 20 months 60 30 *after progressing from TKI 2nd half 2024
- 19. LP-184 for the Treatment of Advanced Solid Tumors Lead Indications DDR deficient solid tumors including Pancreatic cancer, Bladder cancer, and TNBC Clinical Status Phase 1A Market Potential* $14+ Billion Indication Size* 170,000 + Cases, Estimated 400,000 + Cases Global Target/ MOA Double-stranded DNA breaks; alkylates DNA in the 3‘ of Adenine Molecule Type Acylfulvene Class Combination Potential Checkpoint inhibitors, PARP inhibitors, Spironolactone, Chemotherapy and Radiation Therapy IP Estate 10+ patents/pending apps., Claims extending into 2041 *Estimated Annual USA
- 20. Disease Overview – Advanced Solid Tumors with DDR Deficiencies NASDAQ: LTRN 20 LP-184 has Blockbuster Potential Across Multiple Cancers as a Single Agent or in Combination Therapy Annual US Market Potential: $14+ Billion 1 in 4 people have solid tumors with DDR Deficiencies Pancreatic Cancer Triple Negative Breast Cancer Bladder Cancer Lung Cancer • Advanced solid tumor cancers, having spread beyond the primary site, are often more challenging to treat than earlier stage tumors due to their advanced progression. • Current treatment options include: surgery, chemotherapy, radiation therapy, targeted therapy, and immunotherapy (DDR Deficient Solid Tumors) Advanced Solid Tumors DDR is essential for maintaining genomic stability by repairing different types of DNA damage. Inhibition of DDR has been shown to increase the effectiveness of anticancer immunotherapies DNA Damage Response (DDR) Deficiency Cancer cells with high underlying levels of DNA damage are more dependent on DDR for survival when compared to normal cells DDR Deficiencies result in the accumulation of DNA damage, which produces an “Achiles Heel” for drugs leveraging synthetic lethality
- 21. Mechanism of Action – LP-184 NASDAQ: LTRN 21 LP-184 has a unique mechanism of action – leveraging synthetic lethality
- 22. AI insights generated by RADR® – LP-184 NASDAQ: LTRN 22 LP-184’s MoA was predicted by RADR® and validated with In vitro and In vivo studies • Prostaglandin Reductase 1 (PTGR1) is oxidoreductase enzyme that activates LP-184 into its highly potent and cytotoxic form • PTGR1 is frequently elevated in cancers and activates LP-184 inside the cancer cells • RADR® insights predicted that LP-184 activity positively correlates with PTGR1 transcript levels in the NCI60 cancer cell line panel Identified PTGR1 as a Biomarker Predicts LP-184 Response 0 200 400 600 800 1000 0.0 0.2 0.4 0.6 0.8 1.0 LP-184 Concentration (nM) Pancreatic Cancer Cell Viability Validated using CRISPR Experiments B. A. C. 0 200 400 600 800 0.0 0.2 0.4 0.6 0.8 1.0 LP-184 Concentration (nM) Pancreatic Cancer Cell Viability Panc03.27 sgControl Capan-1 sgControl Capan-1 sgPTGR1 Panc03.27 sgPTGR1 • CRISPR-mediated depletion of PTGR1 expression in a pancreatic cancer cell line (Panc03.27) is sufficient to fully diminish LP-184 activity • This confirmed the RADR® insights and that LP-184 was highly potent in cells with overexpression of PTGR1 0 200 400 600 800 1000 0.0 0.2 0.4 0.6 0.8 1.0 LP-184 Concentration (nM) Pancreatic Cancer Cell Viability In silico In vitro
- 23. 23 NASDAQ: LTRN Clinical Trial – LP-184 Phase 1 Basket Trial Launched Phase 1 basket trial for a blockbuster molecule with a market potential of $10+ billion in annual sales *BOIN- Bayesian Optimal Interval LP-184 Phase 1A Trial Design Dose Level 5 (n ≥ 3, BOIN) Dose Level 8 (n ≥ 3, BOIN) MTD* / MAD* Dose Level 8 (n=10 total) Dose Level 7 (n=10 total) (As Needed) *MTD- Maximum tolerated dose *MAD- Maximum administered dose Recommended Dose Range of LP-184 Dose Levels 1-4 (n ≥ 3, BOIN*) First-In-Human Trial for LP-184 Clinicaltrials.gov (NCT05933265) June 2023 July 2023 IND application cleared by FDA Trial launch and initial sites activated First patient dosed Q3 2023* * anticipated
- 24. LP-184 Vehicle CTG-1522 Tumors CTG-1643 Tumors In-vitro PDX pancreatic mouse models treated with LP-184 - CTG-1522 and CTG-1643 models showed a tumor growth inhibition of >100% CTG-1643 - BRCA1 Frameshift mutation • LP-184 exhibits nanomolar potency in PTGR1 overexpressing tumors with DDR deficiencies • Positioned for 2nd and 3rd line treatment, where there is unmet need for novel therapies • FDA Orphan Drug Designation granted for LP-184 to treat pancreatic cancer • Combination therapy potential with SOC agents: Spironolactone, PARP inhibitors, Gemcitabine, Irinotecan, and Oxaliplatin A. Preclinical Results – LP-184 LP-184 treatment results in complete regression in DDR deficient pancreatic cancer PDX models In collab. with Poster: Pancreatic Cancer Triple Negative Breast Cancer (TNBC) Across 10 TNBC PDX mouse models (All 10 TNBC PDX models were HR deficient) LP-184 treatment resulted in 107-141% tumor growth inhibition B. CTG-1522 – ATR Frameshift mutation, non responder to FOLFIRINOX H B C x - 1 H B C x - 8 H B C x - 9 H B C x - 1 6 H B C x - 2 3 H B C x - 2 4 H B C x - 2 8 H B C x - 1 0 H B C x - 1 5 T 1 6 8 H B C x - 1 H B C x - 8 H B C x - 9 H B C x - 1 6 H B C x - 2 3 H B C x - 2 4 H B C x - 2 8 H B C x - 1 0 H B C x - 1 5 T 1 6 8 0 250 500 750 1000 1250 1500 -100 TNBC PDX Tumor Models Percent Tumor Volume Change LP-184 Treatment Control Treatment Control - PARPi Resistant -30% Control - PARPi Sensitive LP-184 - PARPi Resistant LP-184 - PARPi Sensitive 24
- 25. NASDAQ: LTRN 25 LP-184 in NERD Cancers LP-184 in HRD Cancers 0 1 2 3 4 0.00 0.25 0.50 0.75 1.00 LP- 184 Concentration (μM) Relative Survival AA8 (Wild Type) UV5 (ERCC2) UV20 (ERCC1) UV61 (ERCC6) • PDX-derived cell lines with mutations in key HR and NER genes are highly sensitive to LP-184 • Only 1 model was not highly sensitive to LP-184 (highlighted in blue) • LP-184 shows exquisite potency in cancers with deficiencies in Nucleotide Excision Repair (NERD) pathways • There are currently no approved therapies for NERD cancers Preclinical Results – LP-184 Cancer models with common DNA damage response deficiencies are highly sensitive to LP-184 treatment PDX Cancer model IC50 (nM) HRD Mutations NSCLC 31 ATM Prostate 31 PMS2 Pancreatic 45 ATR, BRIP1, PARP1 NSCLC 54 CHEK1, FANCA, NBN, RAD50 Prostate 54 BRCA2, ATM, FANCA, FANCI, FANCM Prostate 54 BRCA2, CDK12, FANCI, RAD54L, NSCLC 57 ATM, FANCD2, NBN Pancreatic 57 BRCA1, BRIP1, Prostate 92 ATM, ATR, PALB2, Pancreatic 110 BRCA2, ATM, BLM, FANCA Pancreatic 270 BRCA2, CDK12, PALB2 Pancreatic 2,900 ATM, BRCA1, BRCA2
- 26. 26 8 12 16 20 24 28 32 36 40 44 0 500 1000 1500 2000 Tumor Volume (mm 3 ) Vehicle Spironolactone LP-184 LP-184 + Spironolactone LP-184 Dosing Days Post Implantation LP-184 + Spironolactone in GBM in vivo mouse model LP-184 + Radiation in the Panc03.27 CDX Model • Spironolactone is an FDA approved agent that can impair DNA damage repair pathways in tumor cells • Combination of LP-184 or LP-284 with Spironolactone: 1) Enhances potency 2) Decreases expected dose needed for treatment 3) Exploits MoA of both drugs • Terminal tumor volumes from the RT + LP-184 treatment group are significantly (**p < 0.01) smaller than treated with RT or LP-184 alone • Mean tumor volumes of RT + LP184 were ~1.8 fold lower than tumors treated with LP-184 alone NASDAQ: LTRN A. B. Preclinical Data on Combination Therapy – LP-184 In-vivo LP-184 has synergy with several SOC agents including spironolactone, radiation therapy, and others
- 27. LP-284 for the Treatment of B-cell Non-Hodgkin’s Lymphomas (NHL) Lead Indications Mantle Cell, Double Hit Lymphomas, DDR Deficient Non-Hodgkin’s Lymphomas Clinical Status IND Filed. Phase 1 Anticipated to commence in 2023 Market Potential* $3.75 - 4 Billion Indication Size* 375,000+ Target/ MOA Synthetic Lethality Molecule Type Acylfulvene Class Designations Orphan Drug - Mantle Cell Lymphoma Combination Potential Rituximab and Spironolactone IP Estate Claims extending into 2039 * Estimated Annual Global
- 28. Disease Overview – B-cell Non-Hodgkin’s Lymphomas NASDAQ: LTRN 28 Superior responses to LP-284 are observed in several B-cell lymphomas Mantle Cell Lymphoma High-Grade B-Cell Lymphoma • A rare, aggressive type of B-cell NHL distinguished by overexpression of CCND1 • Small-medium size cancer cells in the lymph nodes, spleen, bone marrow, blood, and gastrointestinal system • Rarely curable with current standard-of-care treatments and poor prognosis • A rare, aggressive type of B-cell NHL characterized by rearrangements of MYC and BCL2 and/or BCL6 genes • Often occurs in neck, armpit, groins and can spread to central nervous system • No standard treatment approach and poor prognosis. B-cell Non-Hodgkin’s Lymphomas Annual Global Market Potential: $ 4 Billion (NHL) • NHL is a cancer of the lymphatic system and occurs when normal B-cells, T-cells, or Natural Killer (NK)-cells grow out of control • There are over 30 subtypes of NHL including mantle cell lymphoma (MCL), high-grade b-cell lymphoma(HGBL), and diffuse large B-cell lymphoma leading cause of cancer in the US 7th of all cancers are NHL in the US 4% LP-284 treatment on NHL Cell lines (HGBL) (MCL)
- 29. 29 Program Highlights • LP-284 has nanomolar potency against several aggressive non-Hodgkin’s lymphomas (NHL) including mantle cell lymphoma (MCL) and high-grade b-cell lymphoma (HGBL) • FDA granted Orphan Drug Designation for mantle cell lymphoma • In-vivo LP-284 can rescue MCL xenograft tumors resistant to Ibrutinib and Bortezomib • Enhanced potency when used in combination with rituximab in HGBL xenograft models • Received notice of allowance from the USPTO for the composition of matter patent, no. 17/192,838, covering the molecule LP-284, extending commercial protection into early 2039. Recent Highlights Q2 2023 August 2023 Completed IND enabling studies Filed IND application with the FDA Initiate Ph. 1 Trial Launch Q4 2023* Nasdaq: LTRN First-In-Human Trial for LP-284 * anticipated Clinical Trial – LP-284 Phase 1 Trial Ph. 1 trial anticipated to launch in Q4 for recurrent NHLs with scarce therapeutic options
- 30. 30 LP-284 reduced the volume of tumors resistant to Ibrutinib and Bortezomib NASDAQ: LTRN A. B. LP-284 has drastically reduced MCL Tumor Volumes in Mice compared to FDA Approved Agents Nearly all MCL Patients Relapse from SOC Therapies 0 3 6 9 12 15 18 0 1000 2000 3000 Days After Treatment Tumor Volume mm 3 Vehicle LP-284 (2 mg/kg) LP-284 (4 mg/kg) Bortezomib (1 mg/kg) Ibrutinib (50 mg/kg) Vehicle/LP-284 Bortezomib Ibrutinib Preclinical Results – LP-284 Superior responses to LP-284 are observed in several NHLs including those resistant to SOC agents In cell-derived xenograft MCL models, LP-284 can completely reduce tumors that are resistant to Ibrutinib and Bortezomib
- 31. 31 NASDAQ: LTRN Preclinical Data on Combination Therapy – LP-284 LP-284 showed enhanced potency when used in combination with rituximab in HGBL xenograft models HGBL Tumor Volumes in Mice LP-284 – in combination with Rituximab No standard treatment was established for HGBL LP-284 treatment led to near complete tumor growth inhibition and showed synergistic effects with the FDA-approved agent Rituximab LP-284 (2mg/kg) + Rituximab Results presented at:
- 32. NASDAQ: LTRN
- 33. Starlight Therapeutics’ CNS and Brain Cancer Programs were Born from Billions of Datapoints and AI • Multiple Clinical-stage CNS Cancer Indications • 500,000+ Potential CNS Patients Globally* • 4 US Patents & Patent Applications and 10+ Foreign Pending Patent Applications *Estimated Annual Global Numbers • STAR-001 has been Granted FDA Orphan Drug and Rare Pediatric Disease Designations • World Class Collaborators from Johns Hopkins and UT Health San Antonio There are over 120 types of central nervous system (CNS) and brain cancers and a majority have no effective treatment options 5 Year Survival Rates of CNS And Brain Cancers Remain Low Despite Advances in Cancer Therapies • No effective single-agent therapies have been approved for glioblastoma (GBM) in over 17 years • Effective therapies are needed to improve outcomes for brain mets. patients • There are no approved therapies for atypical teratoid rhabdoid tumors (ATRT) • CNS indications were developed using AI in less than 2 years 33 10% BRAIN METS. (TNBC) 7% GBM 32% ATRT
- 34. Multiple Clinical Trials are Planned for STAR-001 Glioblastoma $1.5-2 billion Annual US Cases 13K ATRT & Pediatric CNS $0.1 billion ATRT Annual US Cases 600+ Brain Mets. (Lung, Breast) $3 billion Annual US Cases 100K Other HGGs $1.2 billion Annual US Cases 22K STAR-001 has Multi-billion Market Potential In CNS Cancers $5-6 billion (USD) Global Annual Estimated Market Potential • Upcoming Phase 1 trial for pediatric CNS cancers • Nanomolar potency gives multiple shots on goal in CNS cancers • Upcoming Phase 2 trials for adult CNS cancers • Excellent blood brain barrier permeability • Improved bioavailability over current SOC Agents • Target CNS indications have limited or no effective therapies 34 ADULT CNS CANCERS PEDIATRIC CNS CANCERS Phase3 Phase2 Phase1A INDEnabling Preclinical Discovery - Orphan Drug Designation - Rare Pediatric Disease Designation PediatricCNS indicationswill enterclinicaltrial aftertheAdult Phase1trialsbegin Atypical Teratoid Rhabdoid Tumors (ATRT) Diffuse Intrinsic Pontine Glioma (DIPG) Glioblastoma (GBM) Other High-Grade Gliomas (HGG) Brain Mets. (Triple Negative Breast Cancer) Brain Mets. (Non-Small Cell Lung Cancer) Brain Mets. (Melanoma) Phase1Aisbeing conductedby LanternPharma
- 35. 35 95+ Issued Patents & Pending Applications 5 Families Drug Sensitivity & Response Signatures using Biomarkers 7 Families Methods of Use 2 Families Composition of Matter LP-300 • Acquired • Recent patent (no. 11,471,431) • Claims extending to at least 2032 FDA Orphan Drug Designation • Granted for Pancreatic Cancer, GBM, and Malignant Gliomas in Aug. 2021, for ATRT in Jan. 2022, and for Mantle Cell Lymphoma in Jan. 2023 • Provides 7 years of market exclusivity • Complements patent protections • Reduces costs or provides waivers for marketing/registration fees • Reduces annual product fees • Assistance for expedited program development Pediatric Rare Disease Designation • Granted in Jan. 2022 for ATRT • Eligibility for potential priority review voucher if applicable and approved • Priority review voucher can sell in marketplace for $100-$120 million LP-184 • In-licensed • Internally developed • Claims extending into 2041 LP-284 • Internally developed • Composition of matter patent (no. 11,739,043) • Claims extending into 2039 RADR® Additional Commercial Protections NASDAQ: LTRN IP Portfolio Intellectual property portfolio builds expanding protections with additional barriers to competition
- 36. z 36 Artificial intelligence platform, RADR®, aids in the discovery of DNA damaging agent for the ultra- rare cancer Atypical Teratoid Rhabdoid Tumors American Society of Hematology LP-184, an acylfulvene class small molecule therapeutic, is synthetically lethal in HR deficient and PARP inhibitor resistant triple negative breast cancer Preclinical efficacy of LP-184, a tumor site activated synthetically lethal therapeutic, in glioblastoma Development of a Potent DNA Damaging Agent LP-284 for Treatment of Mantle Cell Lymphoma NASDAQ: LTRN Oct 2022 Nov 2022 Dec 2022 Dec 2022 LP-284, a small molecule acylfulvene, exerts potent antitumor activity in preclinical non-Hodgkin's lymphoma models and in cells deficient in DNA damage repair June 2023 LP-184, an acylfulvene class small molecule therapeutic, is synthetically lethal in DNA damage repair deficient cancers Apr 2023 Recent Posters/ Publications Highlighting the strong validation of RADR® insights, de-risking the development of Lantern’s drug candidates
- 37. Financial Highlights And Cap Table 37 Solid financial position and capital efficiency fuel continued growth and give Lantern cash runway into 2025 *Market Cap based on shares outstanding at 6/30/23 LANTERN PHARMA INC. (LTRN) Exchange Nasdaq Stock Price (9/8/23) $4.48 Common Shares Outstanding (6/30/23) 10.87M Market Cap (9/8/23)* $48.7M Warrants (6/30/23) 178K Options (Employees, Management and Directors) (6/30/23) 1.1M Fully Diluted Shares Outstanding (6/30/23) 12.1M • Approx. $48.0 M of cash, cash equivalents and marketable securities as of June 30th, 2023 • Committed to creating enduring growth and value for LTRN shareholders NASDAQ: LTRN
- 38. Franklyn Prendergast, M.D., Ph.D. Panna Sharma Maria Maccecchini, Ph.D. Lantern’s Board of Directors 38 Donald “Jeff” Keyser, J.D., MPH, Ph.D. Vijay Chandru, Ph.D. David Silberstein, Ph.D. Non-executive Chairman CEO and President NASDAQ: LTRN
- 39. Investment Highlights 39 Lantern Pharma (NASDAQ: LTRN) Focused on cancer drug market segments with clear clinical need, understood mechanisms, targeted patient populations that exceed 1 million , and multi-billion USD in annual sales potential Proven and growing library of AI & machine-learning methodologies published at ASCO, AACR, and SNO used to generate novel IP & patents and accelerate discovery by potentially years Growing AI based platform with clear roadmap to 50+ Bn. datapoints focused exquisitely on cancer therapeutic development and companion Dx in a high growth, high demand $12+ Bn. market Active drug rescue process and in the clinic with 2 compounds and accelerating additional compounds and combinations to clinical trials…potentially saving tens of millions of dollars and years of development Experienced and innovative management team w/ 70+ years experience in cancer and a passion to change the cost and outcome for cancer patients by using AI and genomics – paradigm changing technologies A novel ADC platform with the potential to develop and out-license or partner ADC assets in early phases Several compounds in place with multiple targeted indications, including LP-184 (received Orphan Disease Designations in pancreatic and GBM & Rare Pediatric Disease Designation for ATRT), which can help accelerate development Industry leading collaborations with Georgetown, Johns Hopkins, UT Health San Antonio, Fox Chase Cancer Center, and University of Bielefeld NASDAQ: LTRN
- 40. NASDAQ: LTRN IR Contact: [email protected] 1-972-277-1136 www.lanternpharma.com @LanternPharma CONNECT WITH US Sign up for Newsletter https://lantern-pharma.read.axioshq.com/signup/lantern-pharma-newsletter
- 42. • Professor of Organic and Bioorganic Chemistry at Bielefeld University (Bielefeld, Germany) • Lead investigator of the European consortium Magicbullet::reloaded • Research Focus • Development of antibody-drug and peptide-drug conjugates • Isolation and total synthesis of natural products • Chemical modification of bioactive peptides • Biocatalytic halogenation of amino acids, peptides, and proteins. A1 $4+ billion Rapidly growing global ADC market currently valued at $14+ billion projected value by 2027 Professor Norbert Sewald, Ph.D. • RADR® ADC module will be leveraged to develop novel and potent cryptophycin-ADCs • Lantern received exclusive worldwide option to license IP from Bielefeld University related to, or generated from, collaboration Collaboration Highlights Nasdaq: LTRN RADR® – ADC Collaboration Initiated collaboration w/ Bielefeld Univ. to develop breakthrough cryptophycin ADCs; an entirely new treatment modality
- 43. A2 What is the Blood-Brain-Barrier (BBB)? Blood-brain-barrier (BBB) is a highly selective border that can prevent drugs from entering brain tissues. The BBB prevents an estimated 98% of drugs from entering the brain, which presents a major hurdle for developing drugs to treat brain and central nervous system (CNS) cancers. Lantern Developed Industry Leading and Top Ranked AI Algorithms to Predict BBB Permeability of Any Compound 89-92% Highly accurate BBB permeably predictions Ultra Fast Prediction generation time in ~1 minute TOP 4 Best performing BBB prediction algorithms by The Therapeutic Commons (TDC) Scalable Capable of rapidly screening thousands of compounds simultaneously Lantern’s AI BBB permeability prediction algorithms were evaluated and scored in the BBB drug prediction challenge conducted by Therapeutics Data Commons (TDC), a coordinated initiative to evaluate AI capabilities across therapeutic modalities and stages of discovery. BBB drug prediction challenge conducted by Therapeutics Data Commons (TDC), NASDAQ: LTRN RADR® - BBB Permeability Prediction Algorithm Solving challenging problem in brain cancer drug discovery – predicting any compound’s BBB permeability
- 44. LP-300 – Additional Value Drivers A3 NASDAQ: LTRN Harmonic™ iPhone App • First of their kind iPhone apps launched for the Harmonic™ clinical trial • The new Harmonic™ trial apps provide physicians, patients, caregivers, and the cancer community with mobile access to up-to date information 1. How NSCLC is different in never-smokers 2. What taking part in the Harmonic™ trial involves 3. How to contact the Harmonic™ clinical trial team 4. Information on the investigational new drug, LP-300 5. Locations of all currently active clinical trial sites 6. Education & awareness for the NSCLC community • Trial will collect liquid biopsies and acquire genomic/transcriptomic data from patients. Will represent one of the largest biomarker studies done on the never-smoker population. • Exploring global partnering discussions, for areas with high prevalence of never smokers with NSCLC Liquid biopsies taken at 4 time points Potential Future Clinical Trial Design & Companion Dx “ … higher in East Asia, approximately one third of all lung cancer patients are never smokers (39.7% in China, 38% in South Korea, and 32.8% in Japan)” (Zhou & Zhou, 2018) Liquid Biopsies Global Partnering Opportunities
- 45. Recent Milestones 2023Investment Highlights Upcoming Milestones Advance enrollment of The Harmonic™ Trial & increase patient/clinician awareness Launch and advance clinical trials for LP-184 and LP-284 Advance ADC preclinical development to support future Phase 1 launch and/or partnership Expand RADR® AI platform to 50+ billion datapoints Establish additional RADR® based collaborations with companies and research partners Explore licensing and partnership opportunities with biopharma companies Dosed initial patients in the Harmonic™ clinical trial Received IND clearance from FDA for LP-184, trial launched in July ’23. Established new collaboration with Bielefeld University to develop breakthrough ADCs using AI. Developed industry leading AI algorithms to predict any compound’s ability to cross the BBB. RADR® machine learning models advanced to predict patient responses with 88% accuracy. Advancing patient awareness of our precision trials with multiple patient advocacy groups. A4