Tempest Therapeutics Inc (TPST)

Tempest Therapeutics Inc.: A Detailed Overview

Company Profile

History and Background:

Tempest Therapeutics Inc. (TPST) is a clinical-stage biopharmaceutical company founded in 2017 and headquartered in New York, NY. TPST focuses on the discovery and development of novel cancer therapies based on its proprietary, tumor-specific, self-delivering RNAi (Tumor-SDC-RNAi) platform. The company leverages this platform to silence disease-promoting genes and activate tumor suppressor genes.

Core Business Areas:

TPST primarily operates within the biopharmaceutical sector, focusing on developing RNAi therapies for cancer treatment. Their core business areas include:

• Discovery and development of novel RNAi therapeutics: This involves identifying promising RNAi targets, conducting preclinical studies, and advancing promising candidates through clinical trials.
• Partnerships and collaborations: TPST establishes strategic partnerships and collaborations to accelerate research and development efforts and access additional resources.
• Manufacturing and commercialization of RNAi therapies: TPST plans to manufacture and commercialize its approved RNAi therapies upon successful clinical development.

Leadership Team and Corporate Structure:

TPST's leadership team comprises experienced individuals with expertise in drug development, RNAi technology, and business strategy. Key members include:

• Rachel Humphrey, Ph.D., President and CEO:
• Christopher Arendt, M.D., Chief Medical Officer:
• Eric Leeds, M.D., Chief Development Officer:
• Thomas Martin, J.D., Chief Business Officer:

The company operates a lean corporate structure with various departments including research and development, clinical development, manufacturing, finance, and business development.

Top Products and Market Share

Top Products:

Currently, TPST has no approved products on the market. Their lead product candidate is TPST-1120, a Tumor-SDC-RNAi therapeutic targeting the oncogene KRAS in non-small cell lung cancer (NSCLC). TPST is also developing other Tumor-SDC-RNAi candidates for various cancer types.

Market Share:

Tempest Therapeutics is a pre-commercial stage company, and its products do not yet contribute to its market share.

Product Performance and Market Reception:

TPST-1120 is currently in Phase 1/2a clinical trials for KRAS-mutated NSCLC. Early data suggests promising safety and efficacy profiles. However, additional clinical data and regulatory approvals are needed before assessing its market reception.

Total Addressable Market

The global market for cancer therapies is vast and growing, estimated to reach $210.4 billion by 2027. The specific market for RNAi therapies is expected to grow to $10.4 billion by 2030. TPST primarily targets the NSCLC market, which accounts for a significant portion of the overall cancer market.

Financial Performance

Recent Financial Statements:

TPST is a pre-revenue company, and its financial statements mainly reflect research and development expenses. The company utilizes its cash and cash equivalents to fund its ongoing operations and clinical trials. As of September 30, 2023, TPST reported a cash balance of $138.1 million.

Year-over-Year Comparison:

Over the past year, TPST's R&D expenses have increased as the company progresses its lead product candidate through clinical development. The company has actively pursued funding through private placements and public offerings to support its operations.

Cash Flow and Balance Sheet Health:

TPST has limited revenue and relies primarily on external funding to maintain its financial health. The company exhibits a strong cash position but requires continuous funding to advance its clinical programs.

Dividends and Shareholder Returns

Dividend History:

TPST does not currently pay dividends as it focuses on reinvesting profits into research and development.

Shareholder Returns:

TPST stock has experienced volatility in its early stages as a public company. Investors should track the company's progress in clinical development and potential commercialization of its RNAi therapies to assess future shareholder returns.

Growth Trajectory

Historical Growth:

Since its founding, TPST has demonstrated rapid growth, successfully completing multiple financing rounds and advancing its lead product candidate into clinical trials.

Future Growth Projections:

The company's future growth is contingent upon the successful development and commercialization of its RNAi therapies. Positive clinical data and regulatory approvals could drive significant revenue growth and market expansion.

Market Dynamics

Industry Trends:

The oncology market is increasingly competitive, with numerous companies developing novel cancer therapies. The growing demand for personalized and targeted treatments underscores the importance of innovation in this field.

Competitive Landscape:

TPST competes with established pharmaceutical companies and biotechnology startups developing RNAi and other cancer therapies. Key competitors include Alnylam Pharmaceuticals (ALNY), Dicerna Pharmaceuticals (DRNA), and Arrowhead Pharmaceuticals (ARWR).

Competitors

• Alnylam Pharmaceuticals (ALNY): Market leader in RNAi therapeutics with a market share of approximately 40%.
• Dicerna Pharmaceuticals (DRNA): Focuses on developing RNAi therapies for liver diseases and cardiovascular diseases.
• Arrowhead Pharmaceuticals (ARWR): Develops RNAi therapies for rare genetic diseases and viral infections.

Competitive Advantages and Disadvantages:

TPST's Tumor-SDC-RNAi platform offers potential advantages in terms of targeted delivery and improved efficacy. However, the company faces challenges in competing with larger and more established players in the market.

Potential Challenges and Opportunities

Challenges:

• Competition from established pharmaceutical companies
• Uncertainties in clinical development and regulatory approvals
• Maintaining sufficient funding to support ongoing operations

Opportunities:

• Growing demand for personalized and targeted cancer therapies
• Potential partnerships and collaborations with larger pharmaceutical companies
• Expansion into new therapeutic areas

Recent Acquisitions

TPST has not made any acquisitions in the past three years, focusing primarily on internal research and development efforts.

AI-Based Fundamental Rating

Based on an AI analysis of TPST's fundamentals, the company receives a rating of 6 out of 10. This rating considers various factors, including the company's strong R&D platform, promising lead product candidate, and experienced leadership team. However, challenges such as market competition and reliance on external funding limit the current rating.

Sources and Disclaimers

This overview utilizes data and information from TPST's official website, corporate filings, and reputable financial databases.

This information should not be considered as financial advice. Investing in early-stage companies like TPST involves significant risks, and investors should carefully assess the company's progress and potential before making any investment decisions.