Longeveron Inc. · NASDAQ:LGVN
Longeveron — IPO Roadshow (February 2021)
41 slides from Longeveron's IPO roadshow presentation, Feb 3, 2021
Slide 1: Issuer Free Writing Prospectus dated February 3, 2021
www.longeveron.com Filed Pursuant to Rule 433 Issuer Free Writing Prospectus dated February 3 rd , 2021 File No. 333 - 252234
Slide 2: Forward Looking Statements
Forward Looking Statements 2 This presentation contains forward - looking statements . All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, prospective produ
Slide 3: Harnessing regenerative cells to treat aging-related disease
3 Specialized cells within our body possess unique regenerative qualities to repair and restore damaged tissues and organs . Longeveron is harnessing these special properties to develop safe and effective “off - the - shelf” cellular therapy to treat chronic aging - related disease, improve healthsp
Slide 4: Founding vision of Longeveron
4 Don Soffer Real Estate entrepreneur and businessman. Joshua Hare, MD Cardiologist, University of Miami Health System Founding Director, University of Miami’s Interdisciplinary Stem Cell Institute $25M investment Manufacturing platform; process; technology; research strategy This was the vision of
Slide 5: Longeveron At-a-Glance
Longeveron At - a - Glance □ Developing safe and effective cellular therapies for chronic aging - related diseases □ Lead product, Lomecel - B, made from bone marrow - derived (allogeneic) Medicinal Signaling Cells □ In - house manufacturing for scalable, “off - the - shelf” cell therapy that can be
Slide 6: Aging-Related MSC Decline & Function
Aging - Related MSC Decline & Function 6 □ Decline in number of MSCs □ Decline in proliferating capacity and differentiation potential □ Decrease in expansion rate □ Down regulation of genes involved in cell cycle, DNA replication and repair □ Changes in microRNA expression □ Four - fold increase in
Slide 7: Age is THE risk factor for developing chronic disease
Age is THE risk factor for developing chronic disease. 7 Ng et al. International Journal of Epidemiology , Volume 49, Issue 1, February 2020, Age to first chronic disease. Majority of individuals have at least one chronic disease by the time they are 65 . ↓ Cognition ↓ Lung function ↓ Cardiovascular
Slide 8: Aging, Inflammation and Chronic Disease
Aging, Inflammation and Chronic Disease 8 “ Inflammaging ” MSC decline; Senescence Sarcopenia & Physical Impairment Frailty Neurological Disease Inflammatory diseases Osteoporosis Cancer Metabolic Disease Cardiovascular Disease
Slide 9: Clinical pipeline
9 PHASE 1 PHASE 2 PHASE 3 BLA Filing Alzheimer’s Disease Aging Frailty Research Program Aging Frailty Phase 2b Influenza Vaccine Adjuvant for Aging Frailty Metabolic Syndrome in Aging Frailty (sub - study) 1 Aging Frailty Phase 2 (Japan) Bahamas Treatment Registry Trial Open - label treatment at pat
Slide 10: Lomecel-B: Off-the-Shelf Therapy
Lomecel - B: “Off - the - Shelf” Therapy 10 Healthy adult donors 18 – 45 years old; Rigorously screened. MSCs isolated from bone marrow aspirate MSCs culture - expanded into the billions of cells 40 minute IV infusion. Key Advantages of Lomecel - B : • Easy to administer, store and freeze (“Off - th
Slide 11: How Does Lomecel-B Work?
11 Images from Golpanian et al 2016. Oncotarget . At the organ and tissue level… Pleiotropic mechanisms of action at the cellular level… How Does Lomecel - B Work?
Slide 12: Alzheimer's Disease Research Program
12 Alzheimer’s Disease Research Program □ Completed Phase 1 safety & tolerability study: ▪ Mild Alzheimer’s disease patients (n=33) ▪ Single infusion (Lomecel - B 20 million cells, Lomecel - B 100 million cells or Placebo) ▪ Randomized, placebo - controlled, double - blind ▪ 52 week follow - up ▪ Ef
Slide 13: AD Phase 1: Trial Design
AD Phase 1: Trial Design 13 Initial Clinical Screen MRI Screen Confirmatory PET Screen Major Eligibility Criteria 50 – 80 year old male or female Diagnosed with mild AD according to NIA - AA criteria MMSE score of 18 – 24 On a stable dosage of AChE inhibitor and/or Memantine Major Eligibility Criter
Slide 14: Worsening Cognitive Domain: Mini-Mental State Exam
14 Worsening Cognitive Domain: Mini - Mental State Exam Plotted are means ± SEM. *, p < 0.05 for change in Lomecel - B arm versus placebo.
Slide 15: MRI Volumetry Analyses
15 MRI Volumetry Analyses * 26 Week change in 100M Lomecel - B arms versus Placebo: p = 0.0396; 95% CI 29.68 – 1044.77 Baseline 100M Lomecel - B : 2819.4 “ 353.7 mm 3 Baseline Placebo : 2839.1 “ 353.5 mm 3 Baseline Lomecel - B: 3103.4 “ 496.9 mm 3 Baseline Placebo : 2904.6 “ 448.8 mm 3
Slide 16: Aging Frailty Research Program: HERA Influenza Vaccine Trial
16 Aging Frailty Research Program Phase 1/2 HERA Influenza Vaccine Trial Objective: Can Lomecel - B improve the immune response in Aging Frailty patients receiving influenza vaccine, a group known to mount inadequate immune response to vaccines. □ Phase 1 status : complete (n=22 (3 safety “run - in”
Slide 17: HERA Influenza Vaccine Trial Phase 2
17 Aging Frailty Research Program Phase 1/2 HERA Influenza Vaccine Trial PHASE 2: ENROLLMENT COMPLETE (N=39); SUBJECT FOLLOW - UP ONGOING □ Phase 2 status : enrollment complete (n=39); subject follow - up ongoing □ Primary Objectives : ▪ Compare post - vaccination antibody production in Lomecel - B
Slide 18: HERA Trial: Antibody Production Against Influenza
18 HERA Trial: Antibody Production Against Influenza Phase 1 Subject Data (n=19) □ All subjects, regardless of timing of Lomecel - B infusion, mounted statistically and clinically significant immune response based on antibody production compared to baseline through 4 weeks. □ The CDC found an overal
Slide 19: HERA 6MWT Interim Pooled Analysis
HERA 6MWT Interim Pooled Analysis 19 Pooled results: Phase 1 (n=19 - all Lomecel - B) & Phase 2 (n=29; 14=Lomecel - B; 15=placebo) Difference from placebo of nearly 75 meters Plotted are the mean ± SEM. *, p < 0.05
Slide 20: Aging Frailty Phase 2b Study
20 Aging Frailty Phase 2b Study □ Trial Objectives : ▪ Evaluate whether intervention with Lomecel - B has a beneficial effect on functional mobility and exercise tolerance compared to placebo in subjects with Aging Frailty . □ Trial Design: ▪ Randomized, placebo - controlled, double - blind parallel
Slide 21: Successful Treatment Registry Trial
Successful Treatment Registry Trial 21 □ Lomecel - B imported from Miami to Nassau, Bahamas □ Investigational treatment at participant’s own expense □ Approved by Ministry of Health to administer Lomecel - B for: ▪ Frailty (infusion) ▪ Dementia (infusion) ▪ Osteoarthritis (direct injection) □ Provid
Slide 22: U.S. Market Opportunity: Annual Prevalence
U.S Market Opportunity: Annual Prevalence 22 Aging Frailty Alzheimer’s Disease The Metabolic Syndrome Acute Respiratory Distress Syndrome (ARDS) Hypoplastic Left Heart Syndrome (HLHS) 8.1 million 1 5.8 million 2 87.2 million 3 150,000 annually 4 (unadjusted for COVID - 19 cases) 1,025 annually 5 1 C
Slide 23: Lomecel-B Clinical Strategy Roadmap
Lomecel - B Clinical Strategy Roadmap* 23 2021 2022 Conduct Phase 2 Japan Trial (n=45) Aging Frailty FDA Conduct multidose Phase 2/3 Trial (pending data and discussion with FDA) Alzheimer’s Disease Conduct multidose Phase 2 Trial HLHS Conduct Phase 2 Trial (Funded by NHLBI; Trial conducted by academ
Slide 24: Estimated Use of Proceeds 2021-2022
Estimated Use of Proceeds 2021 - 2022 Research and Development , $13.8 Manufacturing/ Product/Process Development , $2.0 General Corporate Purposes , $7.2 24 • Initiate Phase 2 Alzheimer’s Disease Trial $4.9M • Complete Phase 2b Frailty Trial $1.0M • Initiate Japan Phase 2 Trial $2.2M • Initiate Pha
Slide 25: Valuation Discussion
Valuation Discussion 25 Analysis predicated on a peer group comparables basis, using a blended average of enterprise values (EVs) of selected publicly traded clinical - stage cell therapy companies, and companies with Alzheimer’s disease programs (non big pharma), at similar phases of development. P
Slide 26: Comparables Stratified: Cell Therapy, Alzheimer's, Anti-Aging
Comparables Stratified: Cell Therapy, Alzheimer’s Disease, and “Anti - Aging” Categories 26 Public Cell Therapy Companies Public AD Companies Public & Private “Anti - Aging” Cos. Name Symbol Market Value ($M) Athersys ATHX $376 Biocardia BCDA $60 Brainstorm Cell Tx BCLA $ 199 Caladirius Bio CLBS $40
Slide 27: Barriers to Competition
Barriers to Competition 27 Company - Owned Patent Applications • Allogeneic MSCs for use as a vaccine adjuvant • Allogeneic MSCs for improving humoral immunity • Allogeneic MSCS to treat sexual dysfunction • MSC protein expression from stimuli (potency assay) • MSCs to treat Alzheimer’s disease Lice
Slide 28: Leadership
Leadership 28 Geoff Green, MBA, CEO James Clavijo, CFO Paul Lehr, JD, General Counsel International Executive Director Joshua M. Hare, MD, Co - Founder & CSO Lisa McClain - Moss, Sr. Director, Manufacturing Anthony Oliva, PhD, Senior VP, Scientific Affairs Mr . Green has been with LGVN since 2016 ,
Slide 29: Summary
Summary x Leader in developing cell - based therapies for aging - related chronic disease x Well - developed allogeneic MSC product x State - of - the - art GMP facility for stringent manufacturing x Preliminary safety profile and supportive early clinical data x Robust clinical pipeline x Revenue -
Slide 30: Investor Relations Contact
Investor Relations Contact 30 Investor Relations Crescendo Communications, LLC David Waldman/Natalya Rudman Tel: (212) 671 - 1021 lgvn@crescendo - ir.com
Slide 31: Additional Information
31 Additional Information
Slide 32: Alzheimer's Disease Phase 1: Mini-Mental Status Exam
32 Alzheimer’s Disease Phase 1 Trial: Cognitive Domain: Mini - Mental Status Exam 39 week change in combined Lomecel - B arms versus Placebo: p = 0.0403; 95% CI 0.16 – 6.38 13 week change in 20M Lomecel - B arm versus Placebo: p = 0.0182; 95% CI 0.51 – 4.97 39 week change in 20M Lomecel - B arm vers
Slide 33: Alzheimer's Disease Phase 1: QOL/ADL Domain
33 Alzheimer’s Disease Phase 1: QOL/ADL Domain: ADCS - ADL Improvement 26 Week change in combined Lomecel - B arms versus Placebo: p = 0.0750; 95% CI - 0.93 – 16.86 26 Week change in 20M Lomecel - B arm versus Placebo: p = 0.0118; 95% CI 1.99 – 13.94 • Statistically significant difference in ADCS -
Slide 34: Frailty Progression
Frailty Progression 34 Lifelong wear & tear Subclinical disease Chronic sterile inflammation Mobility & strength limitations; Sarcopenia ; W eight loss; Immune system dysfunction; Infections; neurological disease Disability, dependence & death Inflammation Function
Slide 35: Aging Frailty Physical/Functional Performance Endpoints
Aging Frailty Physical/Functional Performance Endpoints 35 Exercise tolerance Objective Physical & Functional Performance Tests Balance Mobility Strength Fall Risk - 6MWT - 6MWT - Gait speed - SPPB - SPPB - POMA -- Falls Efficacy Scale - SPPB - POMA -- Falls Efficacy Scale - SPPB - Grip strength
Slide 36: Treatment Goals For Aging Frailty
36 Independence & Improved Clinical Outcomes Decreased Inflammation Improved Functional Capacity Better Quality of Life Treatment Goals For Aging Frailty
Slide 37: Walking distance is a powerful predictor of survival in frail elderly patients
Walking distance is a powerful predictor of survival in frail elderly patients. 37 Frail patients hospitalized for care. Ahlund . Clin Interv Aging 2019 6MWT improved at 3 mos. 6MWT stable at 3 mos. 6MWT decline at 3 mos. Frail elderly patients hospitalized for urgent care: Preserved or improved phy
Slide 38: Lomecel-B: Scalable Product
Lomecel - B: Scalable Product ▪ Per donor yield continues to increase with better techniques and equipment ▪ Transition to master cell bank could yield 1000s of doses/donor ▪ We continue to progress towards cost - effective commercial scale process 38 0 250 500 750 1000 2017 2021 FUTURE Doses Averag
Slide 39: Board of Directors
Board of Directors 39 Don Soffer Co - founder Longeveron. Founded Turnberry Associates Brandeis University Joshua Hare, M.D. Co - founded Longeveron Louis Lemberg Professor of Medicine Founding Director of the University of Miami’s Interdisciplinary Stem Cell Institute. Neil Hare, JD President of Gl
Slide 40: Scientific Advisory Board
Scientific Advisory Board 40 Jeremy Walston, MD, Johns Hopkins Medicine • Co - Director, Biology of Healthy Aging Program, Division of Geriatric Medicine and Gerontology • Co - Director, Biology of Frailty Program • Co - Principal Investigator, Older Americans Independence Center Elena Volpi , MD, P
Slide 41: Longeveron LLC Financial History
Longeveron LLC Financial History 41 Financial History (9/30/20) ▪ Founded: Oct 2014 ▪ Financings: $27.0M (equity) ▪ Revenue: $ 3.3M ▪ Grant Awards: $16.2M ▪ Debt: $ 0.5M