Lisata Therapeutics, Inc. · NASDAQ:LSTA
Lisata Therapeutics — Investor Presentation (February 2024)
51 slides from Lisata Therapeutics's investor presentation, Feb 29, 2024
Slide 1: Corporate Presentation – 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 www.lisata.com Corporate Presentation | February 29, 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: Company Overview: Lisata at a Glance
Company Overview Lisata at a Glance 3
Slide 4: Clinical stage company advancing solid tumor targeting and penetration technology
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, there were ~2 million newly diagnosed cancer cases, with solid tumors comprising
Slide 7: Targeting and penetrating tumors present distinct challenges
Targeting and penetrating tumors present distinct challenges • Tumor stroma acts as a physical barrier, limiting the penetration and distribution of anti-cancer agents into the tumor • Tumor microenvironment (TME) immunosuppressive cells contribute to tumor resistance and/or metastases • Prolonged o
Slide 8: Targeted penetration technology enhances drug delivery to solid tumors
RGD peptides can target tumor cells, but do not enhance penetration and delivery of therapeutic agents Internalizing RGD peptides (iRGDs) combine targeting and penetration enhancement LSTA1 (certepetide) is an iRGD that exploits the C-end Rule (CendR) active transport mechanism to target solid
Slide 9: LSTA1 promises optimized solid tumor treatment
LSTA1 converts tumor stroma from a barrier to a conduit for anti-cancer drugs LSTA1 is agnostic to the modality of the companion anti-cancer therapy • Mechanism effective with co-administered or molecularly bound (tethered) anti-cancer therapies • Co-administration presents an initial streamline
Slide 10: LSTA1 development strategy is composed of two main pillars
LSTA1 development strategy is composed of two main pillars Pursue rapid global registration in pancreatic ductal adenocarcinoma (mPDAC), initially combined with gemcitabine/nab- paclitaxel standard-of-care (SoC) • Phase 2b 100% enrolled Demonstrate LSTA1 effectiveness when combined with a variet
Slide 11: Partnerships
Partnerships Noteworthy existing relationships and potential for many more 11
Slide 12: Existing partnerships support LSTA1 promise and broad applicability
Existing partnerships support LSTA1 promise and broad applicability 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/costs in licensed territories • Strategy
Slide 13: LSTA1 Strong Scientific Foundation and Rationale
LSTA1 Strong Scientific Foundation and Rationale 13
Slide 14: LSTA1 mechanism: integrin binding, cleavage, NRP1 binding, transcytosis
Tumor or Tumor Vascular Endothelial Cell αvβ3 β5 LSTA1 (certepetide) A) Integrin binding LSTA1: 9 amino acid cyclic peptide; high binding specificity and affinity to αvβ3/β5 integrins that are upregulated on tumor endothelial cells and tumor cells B) Proteolytic cleavage NRP1 Once bound to αvβ3 & β5
Slide 15: LSTA1 selectively and efficiently facilitates intratumoral penetration
LSTA1 selectively and efficiently facilitates intratumoral penetration Whole body imaging of mice with pancreatic ductal adenocarcinoma (arrow) dosed with Fluorescent Quantum Dots (FQDs) with and without LSTA1 1 Braun et al., Nature Mater. 2014. 2 Liu, Braun et al., Nature Comm. 2017. Etching solu
Slide 16: LSTA1/iRGD activity and broad applicability consistently demonstrated
LSTA1/iRGD activity & broad applicability consistently demonstrated Sampling of >350 scientific publications showing augmentation effects 16 LSTA1 - Strong Scientific Foundation and Rationale Breast cancer + Herceptin®Lung cancer + gemcitabine Zhang, et al., Plos One, 2015 Breast cancer + nanopartic
Slide 17: LSTA1 Phase 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-paclitaxel2 N=431 8.5 mos. 5.5 mos. 23% (99) 0.2% (1) 23%
Slide 18: LSTA1 Phase 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 (CEND1-001) Gemcitabine + Nab-
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 (CEND1-001) Gemcitabine + Nab-Paclitaxel + LSTA1 1 Von Hoff D, et al., New England Journal of Me
Slide 20: Growing evidence of LSTA1 activity in other solid tumors
Growing evidence of LSTA1 activity in other solid tumors PET scan June 2022 PET scan September 2022 Reduction in FDG activity demonstrated1 LSTA1 potentiated a complete response in metastatic gastroesophageal adenocarcinoma 53 y/o male diagnosed with metastatic gastroesophageal adenocarcinoma in J
Slide 21: LSTA1 Clinical Development Portfolio
LSTA1 Clinical Development Portfolio Fast Track (PDAC - USA) Orphan Drug designated (PDAC – USA/EU & GBM – USA) 21
Slide 22: Implications of Fast Track and Orphan Drug designations
Orphan Drug Designation • Incentives such as tax credits, marketing exclusivity, fee waivers and grant eligibility to support clinical trials • Specialized regulatory assistance from FDA's Office of Orphan Products Development (OOPD) FDA Fast Track Designation • More frequent communication with
Slide 23: LSTA1 Clinical Development Portfolio
*Panitumumab may be added for colorectal or appendiceal patients without Ras mutation First-line mPDAC Gemcitabine/nab-paclitaxel with LSTA1 or placebo N=158 AGITG/Lisata Phase 2b (ASCEND) Placebo-controlled Enrollment complete; patients in follow-up Australia & New Zealand Various Solid Tumors Stan
Slide 24: Capital efficient development plan; shared costs and selective geography
First-line Glioblastoma Multiforme (GBM) Temozolomide +/- LSTA1 N=30 Tartu University Lisata Phase 2a Placebo-controlled Enrolling Estonia & Latvia Peritoneal Carcinomatosis (Colon & Ovarian) LSTA1 + HIPEC* intraoperative intraperitoneal lavage N=21 UCSD/Columbia University/Lisata Phase 1b/2a Open-l
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] Various solid tumors (Basket Trial) CENDIFOX [USA] Pancreatic, Colon and Appendiceal Cancers Qilu: Phase 1b/
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] First-line GBM Phase 1b/2a [USA] Peritoneal Carcinomatosis Qilu: Phase 2 [CHN] First-line mPDAC Final PFS/OS data Tumor Penetration data Fina
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 $50.5M Cash & Investments As of 12/31/2023 $0 Debt 1Q2026 Projected Cash Runway Into Common Shares Outstanding (12/31/2023): 8.1 million shares Options Outstanding (12/31/2023): Exercise Price: $0.02 - $4.22 = 1,084,000
Slide 30: Strong Investment Rationale
Strong Investment Rationale 30
Slide 31: Key factors supporting investment in Lisata Therapeutics
* As of 12/31/2023; 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 indicat
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 LSTA1 or placebo Phase 2b (ASCEND) Corroborate Phase 1b results in a placebo- controlled
Slide 35: Development partners and trial rationale (contd.)
Development Partner(s) [Development Venue] Indication and Trial Product/Comparator Stage of Development Strategic Rationale Tartu University/Lisata [Estonia] First-line Glioblastoma Multiforme; Temozolomide ± LSTA1 Phase 2a Assess LSTA1 safety and effectiveness in additional tumor type (GBM) a in pl
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 • LSTA1 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 LSTA1 Placebo IV • Gemcitabine 1000 mg/m2 IV Dose on days 1, 8, 15 every 28 days INTERVENTION Arm (
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 LSTA1 added to SoC in Chinese patients with mPDAC Design Phase 1b/2a open-label study in advanced mPDAC patients of Chinese ethnicity testing SoC chemoth
Slide 39: Phase 1b/2a China trial design
7 Day Safety Evaluation LSTA1 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 LSTA1 Day 1 Phase 1b/2a study evaluating the safety, pharmacokinetics, and preliminary efficacy of LSTA1 for injection in Chinese patients wit
Slide 40: CENDIFOX trial with University of Kansas
Sponsor/Partner University of Kansas Medical Center (Investigator initiated trial in U.S.) KUCC funded; Lisata provides LSTA1 Objective Evaluate the safety and therapeutic effect of LSTA1 in combination with neoadjuvant FOLFIRINOX-based therapies and an EGFR inhibitor for the treatment of panc
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 blinded, randomized PoC trial in various cancers
Sponsor/Partner Lisata (U.S.) Objective Evaluate the preliminary efficacy, safety and tolerability of LSTA1 in combination with standards of care in subjects with advanced solid tumors Design Phase 2 randomized, double-blind, placebo-controlled, proof-of-concept trial in 2nd line head and neck
Slide 43: BOLSTER trial design
Dosed on Days 1, 8 every 21 days X 8 cycles Dosed every 21 days Disease Progression Response rates Safety LSTA1 + paclitaxel Confirm Eligibility Informed Consent Survival Analysis 72-hour run-in without SoC 2nd line HNSCC (after failure on first line IO) R Placebo + paclitaxel N=20 N=20 LSTA1 + cisp
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 LSTA1 when added to SoC in Chinese patients with mPDAC Design Phase 2b, double-blind, placebo-controlled, randomized study evaluating LSTA1 + SoC (Qilu-produced na
Slide 45: Phase 2b China trial design
Days 1, 8, 15 and every 28 days Disease Progression Response rates PFS Safety Gemcitabine + Qilu produced nab-paclitaxel + LSTA1 3.2 mg/kg Confirm Eligibility Informed Consent 1:1 Survival AnalysismPDAC R Gemcitabine + Qilu produced nab-paclitaxel + placebo N=TBD N=TBD Phase 2b, double-blind, placeb
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 operable/inoperable GEC
Sponsor/Partner WARPNINE, Inc. (registered charity in Australia) is funding trial Lisata providing study drug Objective Evaluate LSTA1 safety & therapeutic effect in combination neoadjuvant chemo in operable gastroesophageal (GE) cancers. Evaluate LSTA1 safety and therapeutic effect in combi
Slide 49: iGoLSTA trial design
N=10 NALIFIROX + Nivolumab + LSTA1 N=5 NALIFIROX + Nivolumab N=5 mFOLFIRINOX + Nivolumab N=10 mFOLFIRINOX + LSTA1 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 until progre
Slide 50: Phase 2a trial of LSTA1 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 LSTA1 in combination with standard- of-care (temozolomide) in patients with previously untreated
Slide 51: GBM Phase 2a trial design
Days 1, 2, 3, 4, 5 and every 28 days for 6 cycles Disease Progression Response rates Safety Temodar® + LSTA1Confirm Eligibility Informed Consent 1:1 Survival Analysis 72-hour Run-in without SoC Newly Diagnosed GBM R Temodar® + LSTA1 matching placebo N=20 N=20 Phase 2a proof-of-concept double-blind,
Lisata Therapeutics — Investor Presentation (February 2024) on 6ix