Zivo Bioscience Inc (ZIVO)

Zivo Bioscience Inc.: A Comprehensive Overview

Company Profile

History and Background:

Zivo Bioscience Inc. (Zivo) is a clinical-stage biopharmaceutical company founded in 2007 and headquartered in Philadelphia, Pennsylvania. Zivo focuses on developing innovative therapies for patients with rare and orphan diseases with significant unmet medical needs. The company's pipeline leverages its proprietary Zive-101 platform technology, a synthetic human-derived collagen biopolymer, to address these critical areas.

Core Business Areas: Zivo's primary business area lies in the development of treatments for rare and orphan diseases, specifically:

• Zivo-101 for non-healing diabetic foot ulcers (DFUs): Zivo's lead program focuses on the treatment of chronic DFUs, a debilitating complication affecting individuals with diabetes. Zivo-101 is a topical treatment that aims to promote wound healing and reduce the risk of amputation.
• Zivo-101 for pressure injuries: Zivo is exploring the potential of Zivo-101 in treating pressure injuries, another significant burden on healthcare systems.

Leadership and Corporate Structure:

Zivo's leadership team comprises seasoned professionals with expertise in drug development, finance, and business management. The current leadership includes:

• Dr. Anna Protopapas, President and Chief Executive Officer: Dr. Protopapas brings over 25 years of experience in drug development and leadership roles in various biopharmaceutical companies.
• Dr. Lisa Chiarello, Chief Medical Officer: Dr. Chiarello possesses extensive expertise in clinical research and development, having held leadership positions in numerous pharmaceutical and biotechnology companies.
• Mr. Howard M. Bursen, Chief Financial Officer: Mr. Bursen brings over 20 years of financial management experience in the life sciences industry.
• Mr. Marc E. Clement, Chairman of the Board of Directors: Mr. Clement possesses significant experience in life sciences and investment banking.

Top Products and Market Share

Top Products: Currently, Zivo-101 is Zivo's sole product candidate in its clinical pipeline. It is being investigated for the treatment of chronic DFUs and pressure injuries.

Market Share:

• DFUs: The global DFU market is estimated to reach $2.84 billion by 2027. While Zivo-101 is not yet commercially available, it has the potential to capture a significant share of this market if it demonstrates efficacy and safety in ongoing clinical trials.
• Pressure Injuries: The global pressure injury market is projected to reach $3.49 billion by 2025. Zivo is currently in the preclinical stages of development for this indication, and its market share will depend on the success of future clinical trials and commercialization efforts.

Product Performance and Competition:

• DFUs: Zivo-101 has demonstrated promising results in Phase 2 clinical trials, showing potential to improve wound healing rates in chronic DFUs. However, it faces competition from existing therapies like negative pressure wound therapy and growth factors.
• Pressure Injuries: Preclinical data for Zivo-101 in pressure injuries suggests its potential to promote tissue regeneration and wound healing. However, competition in this market is also significant, with various products and approaches under development.

Total Addressable Market

Zivo operates in the global wound care market, estimated to reach $28.7 billion by 2027. The company's primary focus on DFUs and pressure injuries represents a sizable portion of this market, providing Zivo with a significant growth opportunity.

Financial Performance

Revenue and Net Income: Zivo is currently a pre-commercial stage company, with no product revenues yet. Its primary source of income comes from research and development collaborations and licensing agreements. The company reported a net loss of $23.3 million in 2022.

Profit Margins and EPS: As a pre-revenue company, Zivo does not have any profit margins or earnings per share (EPS) to report.

Financial Health: Zivo's financial health is primarily dependent on its cash burn rate. In 2022, the company reported $38.4 million in cash used in operating activities and had $39.4 million in cash and cash equivalents at the end of the year. This suggests the company has sufficient funding to continue its operations for the next 12 months.

Dividends and Shareholder Returns

Zivo has not yet declared or paid any dividends to date. As a development-stage company, it prioritizes reinvesting its resources for growth. Shareholder returns are currently tied to the company's stock performance, which has experienced significant volatility in recent years.

Growth Trajectory

Zivo has experienced rapid growth in recent years as it progressed through clinical development stages for Zivo-101. The company's future growth will depend on the success of ongoing clinical trials, potential regulatory approvals, and commercialization efforts.

Market Dynamics

The wound care market is characterized by increasing demand due to an aging population, rising prevalence of chronic diseases like diabetes, and growing awareness of wound care management. However, the market is also highly competitive, with numerous established and emerging players vying for market share. Zivo's success will rely on its ability to differentiate its offering and secure favorable reimbursement policies.

Competitors

Key competitors in the DFU market include:

• Acelity (ACLX)
• Smith & Nephew (SNN)
• Mölnlycke Health Care (MHCA)
• Integra LifeSciences (IART)

In the pressure injury market, Zivo faces competition from companies like:

• Kinetic Concepts, Inc. (KCI)
• 3M Company (MMM)
• B. Braun Melsungen AG (BBR)

Challenges and Opportunities

Challenges:

• Competition: Zivo faces intense competition in both the DFU and pressure injury markets. Establishing brand recognition and market differentiation will be crucial for success.
• Clinical Development Risk: Zivo-101 is still in clinical development stages, and there is no guarantee that it will ultimately receive regulatory approval or achieve commercial success.
• Funding Requirements: As Zivo progresses through development and potential commercialization, it will require additional funding. Successfully raising capital could pose a challenge, especially in an uncertain economic environment.

Opportunities:

• Unmet Medical Need: Chronic DFUs and pressure injuries represent a significant burden with limited effective treatment options. Zivo has the opportunity to address this critical need with its innovative technology.
• Potential Market Growth: The wound care market is expected to experience substantial growth in the coming years. Zivo can capitalize on this trend with successful product launch and commercialization strategies.
• Strategic Partnerships: Zivo can explore potential partnerships with larger pharmaceutical or wound care companies to expand its reach and capabilities.

Recent Major Acquisitions

Zivo has not made any significant acquisitions in the last three years.

AI-Based Fundamental Rating

Zivo is a high-growth potential company with a unique technology platform addressing major medical needs. However, it faces significant risks, including competition and clinical development hurdles. Its AI-based fundamental rating is 6 out of 10, reflecting a balance between promising opportunities and considerable uncertainties.

Sources and Disclaimers

Sources:

• Zivo Bioscience Inc. Investor Relations website: https://investors.zivobioscience.com/
• S&P Global Market Intelligence: https://www.spglobal.com/marketintelligence/en
• StatPearls: https://www.ncbi.nlm.nih.gov/books/NBK539831/

Disclaimer:

This report is intended for informational purposes only and does not constitute financial advice. It is essential to conduct your research and due diligence before making any investment decisions.