Plus Therapeutics, Inc. · NASDAQ:PSTV
Plus Therapeutics — IPO Roadshow (September 2019)
21 slides from Plus Therapeutics's IPO roadshow presentation, Sep 16, 2019
Slide 1: Issuer Free Writing Prospectus
Issuer Free Writing Prospectus dated September 16, 2019 Filed pursuant to Rule 433 under the Securities Act of 1933 Relating to the Preliminary Prospectus dated September 16, 2019 Registration Statement No. 333-229485 This free writing prospectus relates to, and should be read together with, the pre
Slide 2: Investor Presentation
Investor Presentation Nasdaq: PSTV September 16, 2019
Slide 3: Forward-Looking Statements
Forward-Looking Statements This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on our management’s current beliefs, expectations and assumptions about future events, conditions and results and on
Slide 4: Delivering More For Patients Positively Impacting Cancer Care
Delivering More For Patients Positively Impacting Cancer Care
Slide 5: A New Oncology Focused Company
A New Oncology Focused Company + ‘PLUS’ is our cost effective pharmaceutical development model whereby novel delivery technology is combined with clinically and commercially-proven drugs to create innovative therapies for patients + Pipeline product candidates address significant unmet or substantia
Slide 6: Our Mission
Our Mission We believe in the critical importance of discovering, developing, and delivering complex and innovative treatments for patients battling cancer and other life-threatening diseases. Our Vision We envision medicines that will drastically enhance clinical and economic outcomes for patients
Slide 7: The PLUS Development Model
The PLUS Development Model Known Safe & Effective APIs New New Delivery Approach and/or Formulation Innovative Therapeutics Novel, Safe & Effective Injectable Drugs 1 Landscape Mapping • Understand clinical & commercial opportunities • Define technology options 2 Redesign • Redesign the API with new
Slide 8: Capabilities and Experience
Capabilities and Experience + Decades of drug, nanotechnology, and combination product development experience + Management team with successful track record in completing clinical trials and launching novel products in the U.S. and internationally + A fully GMP-compliant, validated, state-of-the-art
Slide 9: Pipeline
Pipeline DocePLUS™ Proprietary Innovative Albumin-Stabilized PEGylated Liposomal Docetaxel* DoxoPLUS™ Complex Generic PEGylated Liposomal Doxorubicin Hydrochloride** PROGRAM CANCER TARGET PRECLINICAL PHASE 1 PHASE 2 PHASE 3 REGULATORY REVIEW COMMERCIALIZATION RIGHTS DocePLUS™ Small Cell Lung PLUS -
Slide 10: DocePLUS Design Rationale, PK and PD
DocePLUS™ Design Rationale, PK and PD DocePLUS Formulation + Liposomal encapsulation + Albumin integration + PEG coating DocePLUS Intravascular Solubility Albumin D D Encapsulated Protein Bound Free unbound + DocePLUS Liposomal Encapsulation + Free unbound docetaxel distributed to tissues + Encapsul
Slide 11: DocePLUS Preclinical Findings
DocePLUS™ Preclinical Findings + Preclinical pharmacokinetic data support elevated AUC and C max of docetaxel for nanoparticle formulation + Biodistribution show preferential uptake to lung & liver + Immunodeficient xenograft tumor models in mice show DocePLUS™ efficacy against a range of human tumo
Slide 12: DocePLUS Phase 1 Study Key Findings
DocePLUS™ Phase 1 Study Key Findings + First-in-human, open-label, dose escalation (15-110 mg/m2) study of DocePLUS™ in 29 heavily pretreated patients (~33% had prior TAXOTERE® exposure) with advanced solid tumors at 2 U.S. sites + Safety + DocePLUS™ achieved a 20% increase in MTD vs. standard docet
Slide 13: DocePLUS Clinical Antitumor Activity
DocePLUS™ Clinical Antitumor Activity Patients in Order of % Change Tumor Growth Tumor Shrinkage Pancreas 42.4% Lung 28.4% Gastric 16.5% Ovarian 5.9% Cervix 5.6% Pancreas 4.7% Pancreas 4.4% Uterine 3.6% Ovarian 1.2% Lung 0.7% Lung 0.0% Cervix -1.1% Adeno -7.7% Prostate-10.0% Lung -11.1% Pancreas -12
Slide 14: DocePLUS Development Plan
DocePLUS™ Development Plan Underserved Market Opportunity Small Cell Lung Cancer; >$250M annual revenue potential Therapeutic redesign: known API PLUS new technology Docetaxel PLUS protein-stabilized PEGylated liposome encapsulation Regulatory path Orphan, 505(b)(2) Therapeutic reformulation: CMC, n
Slide 15: Initial Target: Small Cell Lung Cancer
Initial Target: Small Cell Lung Cancer Lung Cancer1 2nd most common cancer 14% of all new cancer cases Leading cause of cancer-related death in U.S. Diagnosed at median age of 70 10-15% classified as Small Cell Lung Cancer1 Smoking is #1 risk factor2 Low 5-year survival of 8-31%3 Most patients relap
Slide 16: Unmet Needs for Second-Line SCLC Treatment
Unmet Needs for Second-Line SCLC Treatment DocePLUS: rationale for use in SCLC Biodistribution favorable for pulmonary delivery Phase I potential efficacy signal in lung cancer (NSCLC) Single-Agent Chemotherapy with HYCAMTIN® Demonstrated activity in SCLC In randomized clinical trial, key endpoints
Slide 17: DocePLUS Market Research
DocePLUS™ Market Research In considering 10 solid tumors and 3 target product profiles, oncologists viewed SCLC as an attractive Phase 2 study indication Low cure rate, rapid progression, low survival Lack of effective treatment options For second-line, view current standard of care as toxic, inconv
Slide 18: DocePLUS Proposed Differentiation in SCLC
DocePLUS™ Proposed Differentiation in SCLC Compared to HYCAMTIN® Convenient dosing schedule: IV infusion over 60 minutes on only day 1 of each 21-day cycle Potential improved biodistribution to lung Potential for improved safety & efficacy Compared to TAXOTERE® Eliminates need for Tween 80 surfactan
Slide 19: Corporate Information
Corporate Information Headquarters: Austin Offices: San Antonio, San Diego Employees: 7 full-time Nasdaq Symbol: PSTV Website: plustherapeutics.com
Slide 20: Key Anticipated Milestones
Key Anticipated Milestones DocePLUS™ Phase 2 Clinical Trial in Small Cell Lung Cancer Q4 2019: FDA clinical trial protocol approval Q3 2020: 1st patient enrolled H2 2021: Patient enrollment complete Pipeline opportunities Expand DocePLUS™ indications Acquire and/or in-license new drugs for niche and
Slide 21: Capitalization
Capitalization Select Data † Cash $4.5M Common Shares Outstanding 443,117 Preferred Shares Outstanding 4,540 Senior Term Loan $9.3M