Lisata Therapeutics, Inc. · NASDAQ:LSTA
Lisata Therapeutics — Investor Presentation (May 2024)
53 slides from Lisata Therapeutics's investor presentation, May 9, 2024
Slide 1: Targeted Therapy Delivered
© L i s a t a T h e r a p e u t i c s , I n c . 2 0 2 4 . A l l r i g h t s r e s e r v e d . Targeted Therapy Delivered David J. Mazzo, Ph.D. President and Chief Executive Officer www.lisata.com Corporate Presentation| May 9, 2024 Nasdaq: LSTA Exhibit 99.2
Slide 2: Forward-looking statements advisory
2 Forward-looking statements advisory 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,
Slide 3: Lisata at a Glance
Lisata at a Glance Company Overview 3
Slide 4: Company Overview
A clinical stage therapeutics development company rapidly advancing a novel solid tumor targeting and penetration technology to improve the efficacy of anti-cancer drugs Seasoned management with successful international drug development experience and expertise Proprietary field- leading technology
Slide 5: Therapeutic Focus and Rationale
Therapeutic Focus and Rationale Problem, Solution and Approach 5
Slide 6: Improved solid tumor cancer treatment is a vital global need
Improved solid tumor cancer treatment is a vital global need Therapeutic Focus and Rationale 6 2022 20 million new cases2 9.7 million deaths 2050 35 million new cases2 18.5 million deaths 77% In 2023, in the U.S. alone, of ~2 million newly diagnosed cancer cases, >90% were solid tumor cancers1 1 htt
Slide 7: Current solid tumor treatments are suboptimal
7 Therapeutic Focus and Rationale Current solid tumor treatments are suboptimal Tumor stroma acts as a physical barrier to anti-cancer agents An immunosuppressive tumor microenvironment (TME) contributes to tumor resistance and/or metastases Prolonged or escalated dosing of non- targeted anti-
Slide 8: Harnessing the CendR transport mechanism for solid tumor penetration
Harnessing the C-end Rule (CendR) transport mechanism for solid tumor penetration Therapeutic Focus and Rationale 8 Improving selective solid tumor penetration to maximize treatment effects RGD peptides target tumor cells, but do not enhance penetration and delivery Internalizing RGD (iRGD) pept
Slide 9: Certepetide promises optimized solid tumor treatment
1 Sugahara, et al. Mol Cancer Ther; 14(1) January 2015; Hamilton, et al., J MolMed. April 2015; and Miyamura, et al., bioRxiv. May 2023. Therapeutic Focus and Rationale Certepetide promises optimized solid tumor treatment 9 Certepetide converts tumor stroma from a barrier to a conduit for anti-can
Slide 10: Certepetide development strategy is composed of two main pillars
Certepetide development strategy is composed of two main pillars Therapeutic Focus and Rationale 10 Pursue rapid global registration in pancreatic ductal adenocarcinoma (mPDAC), initially combined with gemcitabine/nab-paclitaxel standard-of-care (SoC) • Phase 2b 100% enrolled By 2030, pancreatic
Slide 11: Partnerships
Partnerships Noteworthy existing relationships and potential for many more 11
Slide 12: Existing partnerships support certepetide's promise and broad applicability
Existing partnerships support certepetide’s promise and broad applicability Strategic commercial partnership in China with Qilu Pharmaceutical Exclusive rights to certepetide in China, Taiwan, Hong Kong and Macau Qilu assumes all development and commercialization responsibilities/costs in licens
Slide 13: Certepetide: Strong Scientific Foundation and Rationale
13 Certepetide (formerly LSTA1) Strong Scientific Foundation and Rationale
Slide 14: Certepetide mechanism: integrin binding to tumor penetration
Tumor or Tumor Vascular Endothelial Cell αvβ3 β5 Certepetide (LSTA1) A) Integrin binding Certepetide is a 9 amino acid cyclic peptide with high binding affinity and specificity to αvβ3/β5 integrins that are upregulated on tumor cells and tumor endothelial cells (i.e., tumor stroma) B) Proteolytic cl
Slide 15: Certepetide selectively and efficiently facilitates intratumoral penetration
Certepetide selectively and efficiently facilitates intratumoral penetration 1 Braun et al., Nature Mater. 2014. 2 Liu, Braun et al., Nature Comm. 2017. 15 Certepetide - Strong Scientific Foundation and Rationale Whole body imaging of mice with pancreatic ductal adenocarcinoma (arrow) dosed with Flu
Slide 16: Certepetide/iRGD activity and broad applicability consistently demonstrated
Certepetide/iRGD activity & broad applicability consistently demonstrated Sampling of >350 scientific publications showing improved survival with certepetide/iRGD 16 Breast cancer + Herceptin®Lung cancer + gemcitabine Zhang, et al., Plos One, 2015 Breast cancer + nanoparticle Abraxane GI cancer + ad
Slide 17: Certepetide Ph 1b/2a results: improvement of SoC efficacy
N= # of study participants Median Overall Survival Median Progression-Free Survival Objective Response Rate Complete Response Partial Response Stable Disease Progressive Disease Disease Control Rate 16 weeks CA19-9 >20% drop Gemcitabine + Nab-paclitaxel1 N=431 8.5 mos. 5.5 mos. 23% (99) 0.2% (1) 23%
Slide 18: Certepetide Ph 1b/2a results: improved survival vs. SoC alone
1 Von Hoff D, et al., New England Journal of Medicine, 2013. 2 Dean A, et al., The Lancet Gastroenterology & Hepatology, 2022 1.0 3.0 5.0 7.0 9.0 11.0 13.0 Median Overall Survival (Months) Median Progression Free Survival (Months) M on th s Gemcitabine + Nab-paclitaxel Gemcitabine + Nab-paclitaxel +
Slide 19: Consistent improvement across associated endpoints
0.0% 10.0% 20.0% 30.0% 40.0% 50.0% 60.0% 70.0% 80.0% 90.0% 100.0% Complete Response Partial Response Objective Response Rate Disease Control Rate at 16 weeks CA19-9 >20% drop Gemcitabine + Nab-paclitaxel Gemcitabine + Nab-paclitaxel + certepetide 1 Von Hoff D, et al., New England Journal of Medicine
Slide 20: Clinical evidence of certepetide activity in other solid tumors
Clinical evidence of certepetide activity in other solid tumors Certepetide potentiated a complete response in metastatic gastroesophageal adenocarcinoma (mGEAC) FDG-PET* scan June 2022 FDG-PET scan Sept. 2022 Reduction in FDG activity demonstrated1 53-year-old male with mGEAC with significant (>
Slide 21: Certepetide Clinical/Regulatory Development Portfolio
21 Certepetide Clinical/Regulatory Development Portfolio
Slide 22: Certepetide regulatory designations and implications
Certepetide – Clinical / Regulatory Development Portfolio Certepetide regulatory designations and implications 22 FDA Fast Track Designation More frequent communication with and program-specific guidance from FDA Eligible for Accelerated Approval, Priority Review and Rolling Review Certepetide
Slide 23: Certepetide capital efficient development plan
*Panitumumab may be added for colorectal or appendiceal patients without Ras mutation First-line mPDAC Gemcitabine/nab-paclitaxel with certepetide or placebo N=158 AGITG/Lisata Phase 2b (ASCEND) Placebo-controlled Enrollment complete Australia & New Zealand First-line Cholangiocarcinoma (CCA) Gemcit
Slide 24: Certepetide capital efficient development plan (continued)
First-line Glioblastoma Multiforme (GBM) Temozolomide +/- certepetide N=30 Tartu University/ Lisata Phase 2a Placebo-controlled Enrolling Estonia & Latvia Peritoneal Carcinomatosis (Colon & Ovarian) HIPEC* intraoperative intraperitoneal lavage + certepetide N=21 UCSD/Lisata Phase 1 Open-label Enroll
Slide 25: Development Milestones
Development Milestones 25
Slide 26: A wealth of anticipated key milestones
A wealth of anticipated key milestones 26 2Q 2023 3Q 2023 4Q 2023 1Q 2024 2Q 2024 3Q 2024 4Q 2024 1Q 2025 2Q 2025 3Q 2025 4Q 2025 1Q 2026 ASCEND [AUS, NZ] First-line mPDAC BOLSTER Trial [USA] First-line CCA CENDIFOX [USA] Pancreatic, Colon and Appendiceal Cancers Qilu: Phase 1b/2a [CHN] First-line m
Slide 27: A wealth of anticipated key milestones (contd.)
A wealth of anticipated key milestones (contd.) 2Q 2023 3Q 2023 4Q 2023 1Q 2024 2Q 2024 3Q 2024 4Q 2024 1Q 2025 2Q 2025 3Q 2025 4Q 2025 1Q 2026 Phase 2a [EST, LATV] First-line GBM Phase 1 [USA] Peritoneal Carcinomatosis Qilu: Phase 2 [CHN] First-line mPDAC Final PFS/OS data Tumor Penetration data Fi
Slide 28: Financial Highlights
Financial Highlights 28
Slide 29: Capital projected to fund all clinical programs to data
Capital projected to fund all clinical programs to data Financial Highlights 29 $43.3M Cash & Investments As of 3/31/2024 $0 Debt 1Q2026 Projected Cash Runway Into Common Shares Outstanding (3/31/2024): 8.3 million shares Options Outstanding (3/31/2024): Exercise Price: $0.02 - $4.22 = 1,216,100 sha
Slide 30: Investment Thesis
Investment Thesis Rational and focused development program Highly experienced management team Derisked asset based on a body of data Fiscally stable company 30
Slide 31: Key factors supporting investment in Lisata Therapeutics
* As of 3/31/2024; includes investments Key factors supporting investment in Lisata Therapeutics 31 Strong Investment Rationale PEOPLE Seasoned management with successful international development experience and expertise TECHNOLOGY Proprietary field-leading technology in underserved global indicati
Slide 32: Investor Relations Contact
© L i s a t a T h e r a p e u t i c s , I n c . 2 0 2 4 . A l l r i g h t s r e s e r v e d . Investor Relations Contact: John D. Menditto VP, IR & Corporate Communications o: (908) 842-0084 | e: jmenditto@lisata.com Nasdaq: LSTA | www.lisata.com Targeted Therapy Delivered
Slide 33: Appendix
Appendix 33
Slide 34: Development partners and trial rationale
Development Partner(s) [Development Venue] Indication and Trial Product/Comparator Stage of Development Strategic Rationale Lisata/AGITG [Australia/New Zealand] First-line mPDAC; Gemcitabine/nab-paclitaxel with certepetide or placebo Phase 2b (ASCEND) Corroborate Phase 1b results in a placebo-contro
Slide 35: Certepetide capital efficient development plan
Development Partner(s) [Development Venue] Indication and Trial Product/Comparator Stage of Development Strategic Rationale Tartu University/Lisata [Estonia/Latvia] First-line Glioblastoma Multiforme; Temozolomide +/- certepetide Phase 2a Assess certepetide safety and effectiveness in additional tum
Slide 36: ASCEND: Phase 2b, blinded, randomized trial in mPDAC
Sponsor/Partner Australasian Gastro-Intestinal Trials Group (AGITG) in collaboration with the NHMRC Clinical Trials Centre at the University of Sydney Lisata funded (LSTA eligible for ~43% rebate on all qualified R&D expenses in AUS) Objective Corroborate Phase 1b results in a placebo-controll
Slide 37: ASCEND trial design
R INTERVENTION Arm (N=60) • Nab-paclitaxel 125 mg/m2 IV • Certepetide 3.2 mg/kg IV • Gemcitabine 1000 mg/m2 IV Dose on days 1, 8, 15 every 28 days CONTROL Arm (N=30) • Nab-paclitaxel 125 mg/m2 IV • Matching certepetide Placebo IV • Gemcitabine 1000 mg/m2 IV Dose on days 1, 8, 15 every 28 days INTERV
Slide 38: Phase 1b/2a open-label trial in mPDAC in China
Sponsor/Partner Qilu Pharmaceutical (funds all development in China) Objective Evaluate safety, pharmacokinetics and preliminary efficacy of certepetide added to SoC in Chinese patients with mPDAC Design Phase 1b/2a open-label study in advanced mPDAC patients of Chinese ethnicity testing SoC c
Slide 39: Qilu Phase 1b/2a study design
7 Day Safety Evaluation Certepetide 1.6 mg/kg + nab-pac* + gem Days 1, 8, and 15 every 28 days Confirm Eligibility Informed Consent Extension Stage mPDAC 1.6 mg/kg certepetide Day 1 Phase 1b/2a study evaluating the safety, pharmacokinetics, and preliminary efficacy of certepetide for injection in Ch
Slide 40: CENDIFOX Phase 1b/2a trial
Sponsor/Partner University of Kansas Medical Center (Investigator initiated trial in U.S.) KUCC funded; Lisata provides certepetide Objective Evaluate the safety and therapeutic effect of certepetide in combination with neoadjuvant FOLFIRINOX- based therapies and an EGFR inhibitor for the trea
Slide 41: CENDIFOX trial design
Surgery COHORT 1 Resectable and borderline resectable PDAC Key Objectives: • Pathological response • Immune response pre- & post- treatment • PFS, OS FOLFIRINOX X 3 Cycles (± Panitumumab if RAS/BRAF wildtype - Cohorts 2, 3) Tissue immune profiling Biopsy if archival tissue not available COHORT 2 Col
Slide 42: BOLSTER: Phase 2 trial in Cholangiocarcinoma
Sponsor/Partner Lisata (U.S.) Objective Evaluate the preliminary efficacy, safety and tolerability of certepetide in combination with standards of care in subjects with first-line cholangiocarcinoma Design Phase 2 randomized, double-blind, placebo-controlled, proof-of-concept trial in first-li
Slide 43: BOLSTER trial design
Dosed on Days 1, 8 every 21 days X 8 cycles Disease Progression Response rates Safety Confirm Eligibility Informed Consent Survival Analysis certepetide + cisplatin/gemcitabine/durvalumab 72-hour run-in without SoC 1st line Cholangiocarcinoma (CCA) Placebo + cisplatin/gemcitabine/durvalumab N=20 N=2
Slide 44: Phase 2 placebo-controlled trial in mPDAC in China
Sponsor/Partner Qilu Pharmaceutical (funds all development in China) Objective Further evaluate safety and therapeutic efficacy of certepetide when added to SoC in Chinese patients with locally advanced unresectable mPDAC Design Phase 2b, double-blind, placebo-controlled, randomized study eval
Slide 45: Qilu Phase 2b trial design
Days 1, 8, 15 and every 28 days Disease Progression Response rates PFS Safety Gemcitabine + Qilu produced nab-paclitaxel + certepetide 3.2 mg/kg Confirm Eligibility Informed Consent 1:1 Survival AnalysismPDAC R Gemcitabine + Qilu produced nab-paclitaxel + placebo N=60 N=60 Phase 2b, double-blind, pl
Slide 46: iLSTA: Phase 1b/2a trial in locally advanced PDAC
Sponsor/Partner WARPNINE, Inc. (registered charity in Australia) is funding trial Lisata providing study drug Objective Evaluate safety and therapeutic effect of LSTA1 in combination with IO & Chemo in locally advanced non-resectable pancreatic ductal adenocarcinoma (PDAC); determine if inoper
Slide 47: iLSTA trial design
Cohort 2 Gemcitabine + nab-paclitaxel + LSTA1 + Placebo durvalumab N=5 Cohort 1 Gemcitabine + nab-paclitaxel + Placebo LSTA1 + Placebo durvalumab N=5 Cohort 3 Gemcitabine + nab-paclitaxel + LSTA1 + durvalumab N=up to 20 12 weeks 8 weeks tumor burden assessments until 24 months or recurrence 12 month
Slide 48: iGoLSTA: Phase 1b/2a trial in gastroesophageal cancers
Sponsor/Partner WARPNINE, Inc. (registered charity in Australia) is funding trial Lisata providing study drug Objective Evaluate certepetide safety & therapeutic effect in combination neoadjuvant chemo in operable gastroesophageal (GE) cancers. Evaluate certepetide safety and therapeutic eff
Slide 49: iGoLSTA trial design
N=10 NALIFIROX + Nivolumab + certepetide N=5 NALIFIROX + Nivolumab N=5 mFOLFIRINOX + Nivolumab N=10 mFOLFIRINOX + certepetide N=5 mFOLFIRINOX N=5 FLOT Operable Neo-adjuvant Locally Advanced PET CT every 8 weeks Surgery after 8 cycles Biopsy at Screening 16 weeks Biopsy Every 8-week tumor assessment
Slide 50: Phase 2a trial of certepetide with SoC in first-line GBM
Sponsor/Partner Tartu University Hospital (Investigator initiated trial in Estonia) Lisata providing study drug and funding trial Objective Evaluate safety, tolerability, and therapeutic effect of certepetide in combination with standard-of-care (temozolomide) in patients with previously untre
Slide 51: GBM trial design
Days 1, 2, 3, 4, 5 and every 28 days for 6 cycles Disease Progression Response rates Safety Temodar® + certepetideConfirm Eligibility Informed Consent 1:1 Survival Analysis 72-hour Run-in without SoC Newly Diagnosed GBM R Temodar® + certepetide matching placebo N=20 N=20 Phase 2a proof-of-concept do
Slide 52: Phase 1 trial of certepetide + HIPEC in Peritoneal Carcinomatosis
Sponsor/Partner University of California, San Diego (Investigator initiated trial) Objective Evaluate safety of certepetide in combination with hyperthermic intraperitoneal chemotherapy (HIPEC) or HIPEC alone (without certepetide) in patients with peritoneal metastases Design Phase 1 single-ce
Slide 53: HIPEC trial design
Safety Tumor drug concentration PFS OS CRS-HIPEC + certepetideConfirm Eligibility Informed Consent 2:1 5-year Patient Record Review for Survival Analysis Candidate for CRS-HIPEC Non- mucinous appendiceal, colorectal, ovarian carcinoma with ≥ 5 mm peritoneal nodule(s) R CRS-HIPEC N=14 N=7 A Phase I,
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