RenovoRx, Inc. · NASDAQ:RNXT
RenovoRx — Investor Presentation (March 2022)
21 slides from RenovoRx's investor presentation, Mar 14, 2022
Slide 1: Investor Presentation March 2022
Investor Presentation March 2022 (NASDAQ: RNXT) Late-Stage Clinical Biopharmaceutical Company with Novel Therapy Platform to Treat Locally Advanced Solid Tumors
Slide 2: Forward-Looking Statement
Forward-Looking Statement (NASDAQ: RNXT) This presentation and any accompanying oral presentation contain forward-looking statements that involve substantial risks and uncertainties. All statements other than statements of historical facts contained in this presentation, including statements regardi
Slide 3: RenovoTAMP: Trans-Arterial Micro-Perfusion
RenovoTAMPTM: Trans-Arterial Micro-Perfusion (drug/device combination) Therapy Platform RenovoGemTM: Intra-Arterial Gemcitabine + RenovoCath® (first product candidate - regulated as a drug) Economics of a Branded Oncology Drug 3
Slide 4: Company Overview
Company Overview (NASDAQ: RNXT) Phase 3 Lead Drug Product Candidate: RenovoGem • Intra-arterial gemcitabine (chemotherapy) delivered through FDA cleared RenovoCath delivery system • Phase 1/2 and observational registry trial data demonstrated efficacy signals • Phase 3 interim analysis based on pati
Slide 5: Locally Advanced Pancreatic Cancer Market Opportunity
$1B (NASDAQ: RNXT) Locally Advanced Pancreatic Cancer Market Opportunity* Market Opportunity* US: $500M Rest of World: $500M New Orphan Drug Product New Oncology Drug Market Regulatory and Reimbursement Average new oncology drug pricing: Orphan Drug Protection + $150,000/year* New Drug Application (
Slide 6: Addressing a Significant Problem in Cancer Treatment
Addressing a Significant Problem in Cancer Treatment (NASDAQ: RNXT) Hypervascular tumors adequately treated with current therapies Liver tumors are highly vascularized • Large tumor feeders – excellent targets for systemic therapy • Can be accessed and treated with current local therapy techniques H
Slide 7: Our Solution: Trans-Arterial Micro-Perfusion (RenovoTAMP)
Our Solution: Trans-Arterial Micro-Perfusion (RenovoTAMP) (NASDAQ: RNXT) Blood vessel segment is isolated to deliver drug Mechanism: after vessel isolation, increase in pressure across blood vessel wall into tumor tissue forces drug into tumor tissue At ~45mmHg - tissue pressure is 70 overcome, forc
Slide 8: First and Second Indications: Locally Advanced Pancreatic Cancer and Hilar Cholangiocarcinoma
First and Second Indications: Locally Advanced Pancreatic Cancer and Hilar Cholangiocarcinoma (NASDAQ: RNXT) First Indication: Pancreatic Cancer Second Indication: (Orphan Designation) Hilar Cholangiocarcinoma (HCCA), Bile Duct Cancer • One of the deadliest cancers, with poor outcomes (Orphan Design
Slide 9: Real World Flow of RenovoTAMP Therapy
Real World Flow of RenovoTAMP Therapy: 9
Slide 10: How Patients and Physicians Experience RenovoTAMP Therapy
How Patients and Physicians Experience RenovoTAMP Therapy (NASDAQ: RNXT) • Interventional Radiology Lab-based procedure • Patient under local anesthetic/conscious sedation • RenovoCath inserted through femoral artery • Using contrast agent under x-ray fluoroscopy, blood vessel segment adjacent to tu
Slide 11: We Employ De-risked Small Molecule Chemotherapy Drugs
We Employ De-risked Small Molecule Chemotherapy Drugs First Drug Candidate: Intra-Arterial Gemcitabine (NASDAQ: RNXT) Gemcitabine • IV (systemic) gemcitabine marketed in US since 1996 • Established as part of current standard of care for pancreatic cancer and other solid tumors • Potent anti-tumor a
Slide 12: RenovoTAMP and RenovoGem
RenovoTAMP Our Therapy Platform RenovoRx® Trans-Arterial Micro-Perfusion (drug/device combination) RenovoGem intra-arterial gemcitabine + RenovoCath® Our First Product Candidate + 12
Slide 13: RenovoGem Clinical Pipeline
RenovoGem Clinical Pipeline (NASDAQ: RNXT) Discovery Pre-Clinical Phase 1 Phase 2 Phase 3 Pancreatic Cancer PHPH 3 TIGeR-PaC 3 TIGeR-PaC Study Study (Q4(2H ’22/Q1 ‘22 Interim ‘23 Interim Data,Analysis, 1H ‘23 Enrollment ‘23 Enrollment Completion, Completion, 2H ‘252H Data ‘25 Read Data Read out) out
Slide 14: RenovoGem Broad Market Opportunity in Target Cancers
RenovoGem Broad Market Opportunity in Target Cancers (NASDAQ: RNXT) US Annual Incidence of Initial RenovoGem Target Tumor Types • 350,000 total patients diagnosed/year • ~125,000 all locally advanced (stage 3) potentially addressable via RenovoGem RenovoTAMP is broadly applicable to locally advanced
Slide 15: Exclusivity: Orphan Drug Designation + Intellectual Property Portfolio
Exclusivity: Orphan Drug Designation + Intellectual Property Portfolio (NASDAQ: RNXT) • FDA Orphan Drug Designation for RenovoGem provides for 7 years of market exclusivity post NDA approval for: • Pancreatic cancer • Cholangiocarcinoma • 7 US method and device patents issued around Trans-Arterial M
Slide 16: Clinical Development Pathway to Commercialization
Clinical Development Pathway to Commercialization: (NASDAQ: RNXT) Pivotal Phase 3 Trial Designed to Support NDA Submission Pre-Phase 3 IND Study Meeting with FDA: Guidance Received • FDA confirmed study design and proposed endpoints • One Phase 3 study could support New Drug Application approval if
Slide 17: TIGeR-PaC Primary Endpoint Analysis and Enrollment Considerations
TIGeR-PaC Primary Endpoint Analysis and Enrollment Considerations Endpoint Analysis: TIGeR-PaC designed to detect a 6-month difference between control and treatment arms • From time of randomization Interim analysis (estimated Q4 ’22/Q1 ‘23): • Timing dependent on study participant deaths (events):
Slide 18: Highly Experienced Management Team and Board of Directors
Highly Experienced Management Team and Board of Directors (NASDAQ: RNXT) Ramtin Agah, MD, MS David Diamond Chairman, Founder and CMO Director Biomedical Engineer and Interventional Cardiologist, El National Life Sciences and Technology Practice Lead Camino Hospital, Mountain View CA. at Mayer Hoffma
Slide 19: Capital Structure/ Financial Highlights
Capital Structure/ Financial Highlights (NASDAQ: RNXT) $5.10 $45.4M 8.9M 11.8M RNXT / Share Market Capitalization Shares Outstanding FD Outstanding (As of 12/30/21) (As of 12/30/21) (As of 11/1/21) (As of 11/1/21) 152K $27.7M $17.7M 28% 30 Day Average Enterprise Value Cash Insider Ownership Daily Vo
Slide 20: Investment Highlights
Investment Highlights (NASDAQ: RNXT) • De-risked and validated RenovoTAMP approach • Large market ($1B): platform broadly applicable to locally advanced solid tumors • Phase 3 interim data based on patient deaths – estimated Q3 ‘22/Q1 ‘23 • $17.7M or ~$1.98/share in cash, sufficient to get to data r
Slide 21: Where it matters
Company Contact: Shaun R. Bagai, CEO sbagai@renovorx.com +1.650.284.4483 Investor Relations Contact: KCSA Strategic Communications Valter Pinto or Jack Perkins RenovoRx@KCSA.com +1.212.896.1254 (NASDAQ: RNXT) Delivering therapy Where it matters