Lisata Therapeutics, Inc. · NASDAQ:LSTA
Lisata Therapeutics — Investor Presentation (November 2022)
36 slides from Lisata Therapeutics's investor presentation, Nov 10, 2022
Slide 1: Corporate Presentation
C o p y r i g h t © 2 0 2 2 L i s a t a T h e r a p e u t i c s , I n c . A l l r i g h t s r e s e r v e d . LISATA EUTICSTHERAP Targeted Therapy Delivered David J. Mazzo, Ph.D. Chief Executive Officer Corporate Presentation | November 10, 2022 Nasdaq: LSTA www.lisata.com EXHIBIT 99.2
Slide 2: Forward-looking Statements
Forward-looking Statements This presentation contains “forward-looking statements” that involve substantial risks and uncertainties for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, included in
Slide 3: Investment highlights
Investment highlights Stable finances: ~$75.5 million cash & investments as of 9/30/22; no debt Proprietary field-leading technology in underserved global indications backed by a strong IP portfolio Platform technology “validated” by strong existing partnerships with potential for many others Multip
Slide 4: Proprietary platform technologies
Proprietary platform technologies 4 CendR Platform™ - a targeted tissue penetration technology to enhance drug delivery to solid tumors Converts tumor stroma from barrier to conduit for efficient delivery of chemo-, targeted and immunotherapies • Delivery accomplished via co-administration or by t
Slide 5: Clinical development pipeline with broad therapeutic reach
Clinical development pipeline with broad therapeutic reach 5 LSTA1 (aka CEND-1), advancing in a variety of difficult-to-treat solid tumor applications Ongoing multiple studies in first-line, metastatic pancreatic ductal adenocarcinoma (mPDAC) in combination with standard-of-care (SoC) chemotherapy
Slide 6: Noteworthy existing partnerships and the potential for many more
Noteworthy existing partnerships and the potential for many more Strategic partnership in China with Qilu Pharmaceutical Exclusive rights to LSTA1 in China, Taiwan, Hong Kong and Macau Qilu assumes all development and commercialization responsibilities and costs in the licensed territories Pot
Slide 7: Development programs and next milestones
Sponsor/Funding Partner [Development Activity Venue] Trial Products Indication Development Stage Next Development Milestone CendR Platform™ Programs Lisata/AGITG [Australia/New Zealand] Gemcitabine/nab-paclitaxel with LSTA1 or placebo First-Line Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC) Qi
Slide 8: LSTA1 (aka CEND-1) CendR Platform
LSTA1 (aka CEND-1) CendR Platform™
Slide 9: LSTA1 tumor targeting and microenvironment modifying MoA
LSTA1 tumor targeting and microenvironment modifying MoA αvβ3/β5 integrin LSTA1 (Furin & others) Protease Cleavage CendR1 Peptide Fragment Tumor Vascular Endothelial Cell Nucleus or Cargo Co- admin Drug 9 LSTA1 - 9 amino acid cyclic peptide; high binding specificity and affinity to αvβ3/β5 integri
Slide 10: LSTA1 tumor targeting and microenvironment modifying MoA (cont.)
LSTA1 tumor targeting and microenvironment modifying MoA (cont.) Neuropilin-1 CendR Peptide Fragment Co-administered anti-cancer therapy CendR Pathway Tumor Vascular Endothelial Cell Nucleus Gap junction opening 10 The CendR fragment then binds with high affinity to an adjacent receptor, neuropili
Slide 11: LSTA1 selectively and efficiently facilitates intratumoral delivery
LSTA1 selectively and efficiently facilitates intratumoral delivery Pancreatic ductal adenocarcinoma (arrow) imaging with Fluorescent Quantum Dots (FQDs) with and without LSTA1 1 Braun et al., Nature Mater. 2014. 2 Liu, Braun et al., Nature Comm. 2017. 11 FQD + LSTA1 followed by etching solution •
Slide 12: Increased tumor penetration enhances antitumor activity
1 Hurtado de Mendoza et al, Nature Comms, 2021. 2 Liu X et al., J Clin Invest, 2017. 12 Lung cancer + gemcitabine Breast cancer + nanoparticle Abraxane GI cancer + adoptive cell therapyPancreatic ductal adenocarcinoma Orthotopically transplanted KPC PDAC tumors CEND-1 + irinotecan nanoparticles (i.v
Slide 13: Treatment of solid tumors represents a large unmet clinical need
Treatment of solid tumors represents a large unmet clinical need 1 CA A Cancer J Clinicians, Volume: 72, Issue: 1, Pages: 7-33, First published: 12 January 2022, DOI: (10.3322/caac.21708) It is estimated that more than 1.9 million new cases of cancer will be diagnosed in 2022 In the U.S. alone, soli
Slide 14: LSTA1 Phase 1b results reinforce promise of improving SoC efficacy
LSTA1 Phase 1b results reinforce promise of improving SoC efficacy 14 First-line, mPDAC patients from 3 sites in Australia; ► n=31 (29 evaluable); LSTA1 in combination with SoC (gemcitabine + nab-paclitaxel) ► LSTA1 well-tolerated, no dose-limiting toxicities; safety with LSTA1 consistent with SoC a
Slide 15: Ongoing and Planned LSTA1 Clinical Trials
Ongoing and Planned LSTA1 Clinical Trials
Slide 16: ASCEND: Phase 2b randomized, double-blind trial in AUS and NZ
ASCEND: Phase 2b randomized, double-blind trial in AUS and NZ Sponsor/Partner Lisata/Australasian Gastro-Intestinal Trials Group (AGITG) in collaboration with the NHMRC Clinical Trial Centre at the University of Sydney AGITG/LSTA co-funded Design Phase 2b randomized, double-blind study in mPDA
Slide 17: LSTA1 Phase 1b/2 trial in China
LSTA1 Phase 1b/2 trial in China Sponsor/Partner QILU Pharmaceutical (funds all development in China) Design Phase 1b/2 open-label study in advanced mPDAC patients of Chinese ethnicity Study Size 50 subjects (~15 sites) Endpoints Primary: AEs, SAEs, Objective Response Rate, Duration Response
Slide 18: CENDIFOX: Phase 1b/2 trial in U.S.
CENDIFOX: Phase 1b/2 trial in U.S. Sponsor/Partner University of Kansas Medical Center (Investigator initiated trial) KUCC funded; Lisata provides LSTA1 Design Phase 1b/2 open-label study in pancreatic, colon and appendiceal cancers Study Size 50 subjects Endpoints Primary: Drug Safety S
Slide 19: Planned LSTA1 Phase 2 proof-of-concept basket trial
Planned LSTA1 Phase 2 proof-of-concept basket trial Sponsor/Partner Lisata Design Phase 2, randomized, double-blind, placebo-controlled, proof-of-concept trial in multiple advanced solid tumor types (U.S.) with corresponding standards of care Study Size 160 (assuming 4 tumor types) Endpoints
Slide 20: Tissue-Penetrating Nanoparticle (TPN) Platform
Tissue- Penetrating Nanoparticle (TPN) Platform™
Slide 21: TPN Platform for nucleic acid medicine delivery to solid tumors
TPN Platform™ for nucleic acid medicine delivery to solid tumors 21 Early antisense oligonucleotide (ASO) and small interfering RNA (siRNA) anticancer programs failed to translate preclinical efficacy to clinical success • Tumor stroma serves as primary impediment to effective delivery • High dose
Slide 22: TPN Platform addresses nucleic acid tumor delivery challenges
TPN Platform™ addresses nucleic acid tumor delivery challenges 22 Self-Assembly Varying components enables control of particle size and other properties Tumor-Penetrating NanocomplexsiRNA pictured, also demonstrated with single stranded antisense and microRNAs CendR targeting peptide Endosome escape
Slide 23: CD34+ Cell Therapy Platform Technology
CD34+ Cell Therapy Platform Technology
Slide 24: XOWNA (LSTA16) Coronary Microvascular Dysfunction
XOWNA® [LSTA16 (formerly known as CLBS16)] Coronary Microvascular Dysfunction (USA)
Slide 25: XOWNA development status
XOWNA® development status 2525 1 Marinescu MA, et al. JACC Cardiovasc Imaging. 2015;8:210-220 Coronary Microvascular Dysfunction (CMD) represents a large unmet medical need • Deficient heart microvasculature without large vessel obstructive disease causing frequent, severe angina • Not treatable b
Slide 26: HONEDRA (LSTA12) Critical Limb Ischemia
HONEDRA® [LSTA12 (formerly known as CLBS12)] Critical Limb Ischemia (Japan) SAKIGAKE designated – Japan Orphan Drug designated (Buerger’s disease) - USA Advanced Therapeutic Medicinal Product (ATMP) designated – EU
Slide 27: Indication: critical limb ischemia (CLI)
Indication: critical limb ischemia (CLI) Severe arterial obstruction impeding blood flow in the lower extremities • Includes severe rest pain and non-healing ulcers Buerger’s disease (BD: inflammation in small and medium arteries) is a form of CLI associated with a history of heavy smoking (orph
Slide 28: HONEDRA registration-eligible study in Japan
HONEDRA® registration-eligible study in Japan Primary Endpoint Time to continuous CLI-free (2 consecutive monthly visits, adjudicated independently) Target Study Size 35 subjects; recruited across 12 centers in Japan • 30 with no-option CLI (ASO) + 5 with BD; all Rutherford category 4 or 5 Dose
Slide 29: HONEDRA development next steps
HONEDRA® development next steps Combined CLI and BD interim data suggest trend toward efficacy and acceptable safety • HONEDRA® was safe and well tolerated • Treatment group reached CLI-free status faster than SoC group (primary endpoint) Consultation process with the Pharmaceuticals & Medical D
Slide 30: LSTA201 Diabetic Kidney Disease
LSTA201 (formerly known as CLBS201) Diabetic Kidney Disease
Slide 31: LSTA201 in diabetic kidney disease (DKD)
LSTA201 in diabetic kidney disease (DKD) The stages of CKD are determined by GFR rate, an indication of how well the kidneys are filtering blood1 CKD is often associated with progressive microvasculature damage and loss2,3 Preclinical studies show that microcirculation replenishment improves k
Slide 32: LSTA201: Phase 1b open-label, proof-of-concept study in U.S.
LSTA201: Phase 1b open-label, proof-of-concept study in U.S. Endpoints Change in eGFR compared to baseline, assessed at 6 months Change in Urine albumin-to-creatinine ratio (UACR) and urine protein-to-creatinine ratio (UPCR) from baseline to 3 and 6 months Study Size 6 patients (1 sentinel - u
Slide 33: Anticipated milestones
Anticipated milestones Oncology (LSTA1) Programs Ischemic Disease (CD34+ cell therapy) Programs 3333 20 22 2023 2024 HONEDRA® PMDA clinical pre-consultation underway LSTA201 topline data targeted 1Q23 HONEDRA® PMDA non-clinical consultation 2023 HONEDRA® PMDA formal clinical consultation targeted 2Q
Slide 34: Key financial information
Key financial information 34 Cash & Investments: As of September 30, 2022 $75.5 million Nine months ended September 30, 2022, Operating Cash Burn1: $17.0 million Debt as of September 30, 2022: $0 Common Shares Outstanding: As of September 30, 2022 7.9 million shares Options Outstanding as of Septemb
Slide 35: Investment highlights
Investment highlights Stable finances: ~$75.5 million cash & investments as of 9/30/22; no debt Proprietary field-leading technology in underserved global indications backed by a strong IP portfolio Platform technology “validated” by strong existing partnerships with potential for many others Multip
Slide 36: Investor Relations Contact
C o p y r i g h t © 2 0 2 2 L i s a t a T h e r a p e u t i c s , I n c . A l l r i g h t s r e s e r v e d . LISATA EUTICSTHERAP Targeted Therapy Delivered Investor Relations Contact: John D. Menditto VP, IR & Corporate Communications o: (908) 842-0084 | e: jmenditto@caladrius.com Nasdaq: LSTA | ww
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