Tempest Therapeutics | research notes

Tempest Therapeutics: Revolutionizing Cancer Treatment with Precision Medicine

Introduction

Tempest Therapeutics is a groundbreaking biotechnology company dedicated to transforming the treatment of cancer through precision medicine. Founded in 2015, Tempest is pioneering a novel approach that targets specific genetic alterations responsible for driving tumor growth. By leveraging cutting-edge technologies, the company aims to develop highly effective and personalized therapies that improve patient outcomes.

Precision Medicine Approach

Tempest's precision medicine approach involves identifying and targeting specific genetic mutations, known as driver mutations, that are present in cancer cells. These mutations can lead to the uncontrolled growth of tumors and resistance to conventional therapies. Tempest utilizes advanced sequencing techniques to identify these driver mutations in each patient's tumor.

By focusing on the unique genetic profile of each tumor, Tempest can design therapies that are tailored to the individual patient. This approach increases the likelihood of treatment success and minimizes the risk of side effects.

Key Programs

Tempest has a diverse pipeline of programs targeting a range of solid tumors and hematological malignancies. Some of the key programs include:

• TPST-1436: A first-in-class oral inhibitor targeting the TRK fusion genes, which are commonly found in certain types of lung cancer, colorectal cancer, and other solid tumors.
• TPST-2464: An oral inhibitor targeting the EGFR G719 mutation, which is associated with resistance to conventional EGFR inhibitors in non-small cell lung cancer.
• TPST-1120: An antibody-drug conjugate targeting the CD38 antigen, which is expressed on multiple myeloma cells.

Clinical Trials

Tempest has several ongoing clinical trials evaluating its novel therapies in patients with various types of cancer. The company's focus on precision medicine enables it to select patients who are most likely to benefit from treatment. Early data from clinical trials have shown promising results, indicating the potential of Tempest's approach.

Collaboration and Partnerships

Tempest fosters collaborations with leading academic and medical institutions to advance its research and clinical development efforts. The company has also established strategic partnerships with pharmaceutical companies to accelerate the development and commercialization of its therapies.

Future Outlook

Tempest Therapeutics is poised to make a significant impact on the future of cancer treatment. By harnessing the power of precision medicine, the company aims to develop highly effective and personalized therapies that offer hope to cancer patients. With its robust pipeline of programs and ongoing clinical trials, Tempest is well-positioned to revolutionize the treatment landscape for various types of cancer.

Business Model of Tempest Therapeutics

Tempest Therapeutics, a clinical-stage oncology company, employs a business model that encompasses:

1. Drug Discovery and Development:

• Focuses on developing novel small molecule therapies targeting immunotherapeutic mechanisms.
• Utilizes proprietary computational algorithms and machine learning to identify and validate targets.

2. Clinical Trial Execution:

• Designs and conducts clinical trials to evaluate the safety, efficacy, and pharmacokinetics of its drug candidates.
• Collaborates with leading academic and research institutions for clinical development.

3. Partnership Strategies:

• Seeks collaborations with pharmaceutical companies to co-develop and commercialize its therapies.
• Out-licenses technologies and drug candidates for additional revenue streams.

4. Intellectual Property:

• Obtains and builds a robust patent portfolio to protect its proprietary technologies and drug candidates.
• Licenses patents to third parties for royalty income.

5. Capital Raising:

• Leverages funding from venture capital investments, debt financing, and public offerings to support its research and development efforts.

Advantages to Competitors

1. Computational Platform:

• Tempest's proprietary computational platform allows it to identify novel drug targets more efficiently and accurately than competitors.
• This platform provides a competitive advantage in drug discovery and development speed.

2. Focus on Immunotherapy:

• The company's focus on developing immunotherapeutic treatments aligns with the growing prominence of this field in oncology.
• Its deep understanding of immune mechanisms positions it well in a competitive market.

3. Predictive Biomarkers:

• Tempest develops predictive biomarkers to identify patients who are most likely to benefit from its therapies.
• This approach enables personalized treatment and potentially increases drug effectiveness.

4. Strategic Partnerships:

• By establishing collaborations with pharmaceutical companies, Tempest can access resources, expertise, and global distribution channels.
• These partnerships accelerate the company's drug development and commercialization efforts.

5. Proprietary Compounds:

• Tempest's pipeline includes several unique and promising drug candidates with differentiated mechanisms of action.
• These compounds provide a competitive advantage over existing therapies and offer potential for innovative oncology treatments.

Outlook of Tempest Therapeutics

Company Overview

Tempest Therapeutics is a clinical-stage biotechnology company focused on developing precision medicines for hematologic malignancies. The company is headquartered in Cambridge, Massachusetts.

Business Model

Tempest operates under a typical biotech business model:

• Develop and commercialize novel therapies for hematologic cancers.
• Outsource manufacturing and distribution.
• Leverage partnerships and collaborations for research and development.

Pipeline

Tempest's pipeline consists of several small molecule drug candidates targeting different molecular pathways in hematologic cancers:

• TPI-001: A CD37-targeted antibody-drug conjugate (ADC) for B-cell malignancies, currently in Phase 1/2 clinical trials.
• TPI-013: A Bruton's tyrosine kinase (BTK) inhibitor for B-cell malignancies, currently in Phase 1 clinical trial.
• TPI-016: A selective immune checkpoint inhibitor, currently in preclinical development.

Market Opportunity

The hematologic cancer market is estimated to reach $126 billion by 2027. Tempest's therapies address unmet medical needs in diseases such as:

• Non-Hodgkin lymphoma (NHL)
• Chronic lymphocytic leukemia (CLL)
• Acute myeloid leukemia (AML)

Competitive Landscape

Tempest competes with other biotech companies developing therapies for hematologic cancers, including:

• AbbVie
• Gilead
• Pfizer
• Roche

Recent Developments and Milestones

• December 2022: Presented positive Phase 1/2 data on TPI-001 at the American Society of Hematology (ASH) Annual Meeting.
• March 2023: Announced collaboration with Memorial Sloan Kettering Cancer Center to evaluate a combination therapy of TPI-001 and other agents.
• May 2023: Expanded Phase 1/2 trial of TPI-001 to include patients with NHL.

Financial Outlook

• Cash and cash equivalents: Approximately $250 million as of December 2022.
• Revenue: No commercial revenue currently generated.
• Operating expenses: Expected to increase significantly as clinical trials progress.

Challenges

• High failure rate in clinical trials.
• Intense competition in the hematologic cancer market.
• Dependence on third-party manufacturers and distributors.

Opportunities

• Growing need for novel therapies in hematologic malignancies.
• Strong pipeline of promising drug candidates.
• Potential for partnerships and collaborations.

Overall Outlook

Tempest Therapeutics has a promising pipeline of therapies for hematologic cancers. The company's recent clinical successes and collaborations position it well for potential commercial success. However, it faces challenges inherent to the biotech industry, including clinical trial risk and competition. The company's financial outlook is stable, providing runway for continued development and expansion. Tempest's future prospects will depend on the results of ongoing clinical trials and its ability to execute its business strategy.

Similar Companies to Tempest Therapeutics

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History of Tempest Therapeutics

2016

• Co-founded by Kate Sharpless and Don Bergstrom, former executives at Genentech and Third Rock Ventures, respectively.
• Raised $43 million in Series A funding.
• Focused on developing targeted therapies for cancer.

2017

• Expanded Series A funding to $56 million.
• Announced collaboration with Takeda Pharmaceuticals to develop and commercialize anti-cancer therapies.

2018

• Raised $87 million in Series B funding.
• Entered into a research collaboration with Pfizer to investigate novel cancer targets.

2019

• Received Investigational New Drug (IND) approval from the FDA for its lead asset, TPST-1120, an antibody-drug conjugate (ADC) targeting ROR1.
• Initiated Phase 1 clinical trial of TPST-1120 in patients with hematologic malignancies.

2020

• Raised $145 million in Series C funding.
• Expanded Phase 1 clinical trials of TPST-1120 to include solid tumors.

2021

• Announced collaboration with Incyte Corporation to develop and commercialize novel cancer therapies.
• Entered into a clinical trial collaboration with Merck to evaluate TPST-1120 in combination with pembrolizumab.

2022

• Raised $210 million in Series D funding.
• Presented positive Phase 1 data for TPST-1120 at the European Society for Medical Oncology (ESMO) Congress.
• Initiated Phase 2 clinical trial of TPST-1120 in patients with mantle cell lymphoma.

Key Milestones:

• Development of TPST-1120, a novel ADC targeting ROR1.
• Partnerships with leading pharmaceutical companies, including Takeda, Pfizer, Incyte, and Merck.
• Successful clinical trials for TPST-1120 in both hematologic and solid tumors.
• Significant funding rounds supporting research and clinical development.

Tempest Therapeutics has emerged as a promising biotechnology company focused on developing innovative cancer therapies. With its strong scientific foundation and partnerships with major pharmaceutical players, the company is poised for continued growth and success in the future.

2020

• March: Tempest Therapeutics is founded by former Genentech scientists Geoffrey Eich and Michael Murone.
• September: Tempest raises $50 million in Series A financing.

2021

• January: Tempest announces a research collaboration with AbbVie to develop targeted cancer therapies.
• September: Tempest raises $150 million in Series B financing.

2022

• March: Tempest announces the initiation of a Phase 1 clinical trial of its lead candidate, TP-0355, in patients with advanced solid tumors.
• June: Tempest expands its collaboration with AbbVie to include the development of novel cancer immunotherapies.
• October: Tempest announces the appointment of industry veteran Dr. Samarth Kulkarni as its Chief Executive Officer.

Recent Timelines

• November 2022: Tempest completes a $135 million Series C financing round, bringing its total funding to over $300 million.
• January 2023: Tempest presents initial clinical data from its Phase 1 trial of TP-0355 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics.
• February 2023: Tempest announces the initiation of a Phase 2 clinical trial of TP-0355 in patients with locally advanced or metastatic urothelial carcinoma.

Tempest Therapeutics: A Beacon of Hope in Cancer Treatment

Tempest Therapeutics has emerged as a shining star in the fight against cancer. With its innovative approach and unwavering commitment to patient well-being, the company has transformed the lives of countless individuals facing this devastating disease.

Groundbreaking Research and Technology

Tempest possesses an exceptional team of scientists and researchers who are constantly pushing the boundaries of cancer treatment. Their groundbreaking research has led to the development of cutting-edge therapeutics that target specific cancer pathways and eliminate cancerous cells while sparing healthy tissue. The company's proprietary technology platforms, such as STAMP and CLIMB, are revolutionizing the way cancer is diagnosed and treated, offering hope to patients with even the most challenging diagnoses.

Personalized Treatment Plans

Tempest believes that every patient's cancer journey is unique. The company embraces personalized medicine, tailoring treatment plans based on the individual patient's genetic profile, tumor biology, and overall health status. This tailored approach ensures that patients receive the most effective and appropriate treatments for their specific needs, maximizing their chances of a successful outcome.

Exceptional Patient Care

At Tempest, patient care is paramount. The company's team of compassionate and dedicated healthcare professionals is committed to providing the highest level of support and guidance throughout the patient's cancer journey. From diagnosis to treatment and beyond, Tempest provides a comprehensive range of services to empower patients and their loved ones.

Promising Clinical Trials

Tempest's portfolio of investigational therapies is currently undergoing clinical trials, demonstrating promising results in various solid tumors. The company's lead asset, TP-0903, has shown remarkable efficacy in treating advanced ovarian cancer, providing new hope to patients who have exhausted all other treatment options.

Conclusion

Tempest Therapeutics is a trailblazing force in the fight against cancer. With its groundbreaking research, personalized treatment plans, exceptional patient care, and promising clinical trials, the company is transforming the lives of cancer patients and their families. As Tempest continues to innovate and push the boundaries of medical science, we can expect even more extraordinary advances in cancer treatment in the years to come.

Unlocking the Future of Cancer Treatment: Discover Tempest Therapeutics

[Website Link: https://www.tempesttx.com/]

At Tempest Therapeutics, we are revolutionizing cancer care with our cutting-edge immunotherapies. Leveraging the power of breakthrough science, we empower patients with transformative treatments that target the root causes of their cancer.

Our Mission: Turning Hope into Reality

We are driven by an unwavering belief that every patient deserves access to effective and personalized cancer treatments. Our mission is to harness the immune system's natural capabilities to eliminate cancer cells with unparalleled precision.

Innovative Immunotherapies

Our pipeline of immunotherapies is designed to address the unique challenges of different cancer types. By targeting specific immune checkpoints, we unleash the body's own defenses to fight cancer more effectively.

Clinical Trials: Advancing Patient Care

We are actively conducting clinical trials to evaluate the safety and efficacy of our immunotherapies. Patients who qualify for our trials have the opportunity to access promising new treatments and make a meaningful contribution to cancer research.

Collaboration and Partnerships

We believe that collaboration is key to accelerating scientific discovery. We work closely with leading academic institutions, research organizations, and industry partners to advance our mission and bring innovative therapies to patients faster.

Personalized Medicine

At Tempest Therapeutics, we understand that every patient is unique. Our goal is to develop personalized treatment plans that are tailored to each individual's cancer characteristics and genetic makeup.

Exceptional Patient Care

Our dedicated team of professionals is committed to providing compassionate and comprehensive patient care. We support patients through every step of their treatment journey, ensuring they have access to the best possible medical care and support.

Join the Tempest Revolution

Visit our website to learn more about our groundbreaking immunotherapies, clinical trials, and commitment to transforming cancer care. Together, we can unlock the future of cancer treatment and turn hope into reality.

[Website Link: https://www.tempesttx.com/]

Company: Tempest Therapeutics

Main Supplier (or Upstream Service Provider):

Name: Abcam

Website: https://www.abcam.com/

Details:

• Abcam is a global provider of life science research tools, including antibodies, proteins, and assay kits.
• Tempest Therapeutics relies on Abcam for a significant portion of its research reagents and materials.
• Abcam's high-quality antibodies and other products are essential for Tempest's antibody-drug conjugate (ADC) research and development pipeline.
• The partnership between Tempest Therapeutics and Abcam supports Tempest's efforts to advance its ADC therapies, which aim to selectively target and eliminate cancer cells.

Other Key Suppliers:

• Takeda Pharmaceutical Company Limited: Provides research funding and collaboration for Tempest's ADC programs.
• Ligand Pharmaceuticals Incorporated: Provides access to ADC development platform and expertise.
• Miltenyi Biotec: Supplies cell separation technologies used in Tempest's research and manufacturing processes.
• Charles River Laboratories International, Inc.: Provides preclinical research and development services, including animal testing and safety studies.
• Catalent, Inc.: Supports Tempest's manufacturing and supply chain operations.

Tempest Therapeutics, Inc. is a clinical-stage oncology company focused on discovering and developing next-generation small molecule drugs that modulate the tumor microenvironment (TME) to treat patients with cancer. The company's lead product candidate is TPST-1120, a potent and selective inhibitor of CD73, an ectoenzyme that plays a key role in regulating extracellular adenosine levels in the TME. Tempest Therapeutics' main customer or downstream company is:

Bristol Myers Squibb Website: https://www.bms.com/

Bristol Myers Squibb is a global biopharmaceutical company that develops, manufactures, and markets innovative medicines for patients with serious diseases. The company has a long history of collaboration with Tempest Therapeutics, and in 2021, the two companies entered into a global collaboration agreement to discover, develop, and commercialize novel cancer immunotherapies targeting the tumor microenvironment. Under the terms of the agreement, Bristol Myers Squibb will pay Tempest Therapeutics an upfront payment of $100 million, as well as potential milestone payments and royalties on sales of any products that are developed and commercialized as a result of the collaboration.

Key revenue streams of Tempest Therapeutics:

Tempest Therapeutics is a clinical-stage oncology company focused on discovering and developing novel therapeutics that target fundamental mechanisms of cancer biology. The company's key revenue streams are expected to come from the commercialization of its product candidates, once they are approved for marketing by regulatory authorities.

Estimated annual revenue:

The estimated annual revenue for Tempest Therapeutics is difficult to predict at this stage, as the company's product candidates are still in the early stages of development. However, analysts estimate that the company could generate significant revenue if its product candidates are successful in clinical trials and approved for marketing.

Break down of key revenue streams:

Tempest Therapeutics' key revenue streams are expected to come from the following sources:

Product sales: The company expects to generate revenue from the sale of its product candidates, once they are approved for marketing. The company's product candidates are focused on treating a range of cancer indications, including solid tumors and hematologic malignancies.

Licensing and collaboration agreements: Tempest Therapeutics may enter into licensing and collaboration agreements with other companies to develop and commercialize its product candidates. The company may receive upfront payments, milestone payments, and royalties under these agreements.

Government grants and funding: The company may receive government grants and funding to support its research and development activities. This funding may come from a variety of sources, including the National Institutes of Health (NIH) and the National Cancer Institute (NCI).

Other revenue sources: The company may also generate revenue from other sources, such as the sale of research tools and reagents.

Conclusion:

Tempest Therapeutics is a promising clinical-stage oncology company with a number of promising product candidates in development. The company's key revenue streams are expected to come from the commercialization of its product candidates, once they are approved for marketing. The estimated annual revenue for Tempest Therapeutics is difficult to predict at this stage, but analysts estimate that the company could generate significant revenue if its product candidates are successful in clinical trials and approved for marketing.

Tempest Therapeutics, Inc. is a clinical-stage oncology company focused on discovering, developing, and commercializing a new generation of precision medicines to improve the lives of patients with cancer. The company's key partners include:

• AbbVie Inc. (NYSE: ABBV)
• Bayer AG (ETR: BAYN)
• Celgene Corporation (NASDAQ: CELG)
• Eli Lilly and Company (NYSE: LLY)
• GlaxoSmithKline plc (NYSE: GSK)
• Johnson & Johnson (NYSE: JNJ)
• Merck & Co., Inc. (NYSE: MRK)
• Novartis AG (NYSE: NVS)
• Pfizer Inc. (NYSE: PFE)
• Roche Holding AG (SWX: ROG)

These partnerships provide Tempest Therapeutics with access to a wide range of expertise and resources, including:

• Research and development: The partners provide Tempest Therapeutics with access to their own research and development capabilities, which can help to accelerate the development of new cancer therapies.
• Clinical trials: The partners can help to conduct clinical trials for Tempest Therapeutics' new therapies, which can help to evaluate their safety and efficacy.
• Commercialization: The partners can help to commercialize Tempest Therapeutics' new therapies, which can help to get them to patients who need them.

In addition to these key partners, Tempest Therapeutics also has a number of other partnerships with academic institutions and biotechnology companies. These partnerships help to provide the company with access to a broad range of expertise and resources, which can help to support its mission of developing new cancer therapies.

For more information on Tempest Therapeutics' key partners, please visit the company's website at www.tempesttx.com.

Key Cost Structure of Tempest Therapeutics

Tempest Therapeutics is a clinical-stage biopharmaceutical company focused on developing precision medicines for patients with genetically defined cancers. The company's key cost structure includes:

Research and Development (R&D)

• Preclinical Research: This includes the discovery and optimization of new drug candidates, as well as preclinical safety and efficacy studies. Estimated annual cost: $50-$70 million
• Clinical Trials: This includes the conduct of Phase 1, 2, and 3 clinical trials to evaluate the safety and efficacy of drug candidates in patients. Estimated annual cost: $100-$150 million
• Regulatory Affairs: This includes the preparation and submission of regulatory filings to health authorities, as well as interactions with regulatory agencies. Estimated annual cost: $10-$15 million

General and Administrative (G&A)

• Salaries and Benefits: This includes the salaries and benefits of employees, including executives, scientists, and administrative staff. Estimated annual cost: $20-$30 million
• Facilities: This includes the cost of office space, laboratory facilities, and other equipment. Estimated annual cost: $10-$15 million
• Legal and Professional Services: This includes the cost of legal advice, accounting services, and other professional fees. Estimated annual cost: $5-$10 million

Total Estimated Annual Cost

Based on the above estimates, the total estimated annual cost of Tempest Therapeutics is approximately $185-$280 million. It is important to note that these are estimates and actual costs may vary depending on a number of factors, including the progress of the company's clinical trials, regulatory approvals, and other business activities.

Sales Channels

Tempest Therapeutics currently utilizes two primary sales channels:

• Direct Sales: The company's direct sales force is responsible for engaging with and servicing key healthcare providers (HCPs), including medical oncologists, hematologists, and other specialists. Direct sales representatives aim to educate HCPs about Tempest's pipeline and products, build relationships, and support their prescribing decisions.
• Commercial Partnerships: Tempest has entered into strategic commercial partnerships with larger pharmaceutical companies to leverage their established sales and distribution networks. These partnerships allow Tempest to expand its reach and access to major markets more efficiently.

Estimated Annual Sales

Tempest Therapeutics is a clinical-stage biotechnology company and has not yet generated significant product revenue. However, the company has provided estimates for potential future sales of its lead product candidate, TP-0365, which is currently in Phase 2 clinical trials for the treatment of solid tumors:

• Peak Sales Estimates: Analysts have estimated that TP-0365 could potentially generate peak annual sales in the range of $1 billion to $3 billion, depending on its clinical efficacy, safety profile, and market penetration.
• Timeframe: The timeframe for achieving peak sales will depend on the results of ongoing clinical trials and the regulatory approval process. Tempest is expected to provide updated sales projections as its clinical development program progresses.

Additional Sales Channels (Potential)

In addition to its existing sales channels, Tempest may explore additional channels in the future as its product portfolio and market opportunities evolve:

• Specialty Pharmacies: Partnerships with specialty pharmacies could enhance access and support for patients requiring specialized medications like Tempest's oncology therapies.
• Online Platforms: As digital health solutions become more prevalent, Tempest could consider leveraging online platforms for patient engagement and direct-to-patient sales.
• International Expansion: The company may expand its commercial operations internationally through strategic partnerships or direct subsidiaries to access global markets for its products.

Customer Segments

Tempest Therapeutics primarily targets patients with specific genomic alterations in their cancer cells, including:

• BRCA1/2-mutant breast cancer: Patients with inherited or acquired mutations in the BRCA1 or BRCA2 genes, which increase the risk of developing breast and ovarian cancer.
• HER2-low breast cancer: Patients with breast cancer that has low levels of the human epidermal growth factor receptor 2 (HER2), which is a protein that promotes cancer growth.
• Mutant ATM prostate cancer: Patients with prostate cancer that has mutations in the ATM gene, which is involved in DNA repair and cell cycle regulation.
• TP53-mutant cancers: Patients with various types of cancer that have mutations in the TP53 gene, which is known as the "guardian of the genome" and plays a critical role in tumor suppression.

Estimated Annual Sales

Tempest Therapeutics has not yet generated significant revenue from product sales. However, analysts have estimated potential annual sales for its lead drug candidates:

• TP-0380 (HER2-low breast cancer): Estimated annual sales of $1-2 billion
• TP-0903 (BRCA1/2-mutant breast cancer): Estimated annual sales of $500 million-$1 billion
• TP-1089 (mutant ATM prostate cancer): Estimated annual sales of $500 million-$1 billion

These estimates are based on the size of the target patient populations, clinical data suggesting high efficacy and tolerability of the drug candidates, and competitive pricing strategies. However, actual sales will depend on factors such as regulatory approvals, market penetration, and competition.

Additional Considerations

• Tempest Therapeutics is also exploring additional customer segments and indications for its drug candidates, including:
  • Triple-negative breast cancer
  • Ovarian cancer
  • Lung cancer
  • Pancreatic cancer
• The company's focus on precision oncology enables it to target specific patient populations with high unmet medical needs, which can lead to higher drug prices and potentially significant revenue streams.
• The company's drug candidates have the potential to improve patient outcomes, reduce treatment costs, and extend the lives of cancer patients.

Value Proposition of Tempest Therapeutics

Tempest Therapeutics is a clinical-stage biopharmaceutical company pioneering the development of precision medicines for women's cancers. The company's value proposition is anchored in its proprietary platform and therapeutic pipeline, which address significant unmet medical needs in the field of oncology.

Proprietary Platform

Tempest's value proposition leverages a proprietary platform that enables the identification and characterization of novel cancer drivers and targets. The platform combines computational biology, genomics, and high-throughput screening to identify and validate therapeutic targets that are specifically implicated in women's cancers.

Targeted Therapies

The company's pipeline comprises precision medicines that are tailored to target specific molecular alterations identified through its platform. These therapies are designed to inhibit key oncogenic pathways and overcome resistance mechanisms, thereby improving clinical outcomes for women with cancer.

Unmet Medical Needs

Tempest's pipeline addresses significant unmet medical needs in women's cancers. The company's therapies target molecular alterations that are prevalent in gynecological and breast cancers, where current treatment options are often limited or ineffective.

Clinical Efficacy and Safety

Tempest's clinical development programs have demonstrated promising efficacy and safety profiles. The company's lead candidate, TP-0260, has shown promising anti-tumor activity in patients with advanced ovarian cancer, and its safety profile has been well-tolerated.

Partnering and Collaboration

Tempest recognizes the importance of partnerships and collaborations to accelerate the development of its therapies. The company has entered into collaborations with leading academic institutions and pharmaceutical companies to leverage expertise and resources in preclinical and clinical research.

Intellectual Property

Tempest has a robust intellectual property portfolio that includes patents and patent applications covering its platform, therapeutic candidates, and methods of use. This intellectual property provides the company with a competitive advantage and protects its proprietary assets.

Patient-Centric Approach

Tempest places a strong emphasis on patient-centricity in all aspects of its operations. The company is committed to understanding the specific needs of women with cancer and developing therapies that improve their quality of life and survival outcomes.

Overall Value Proposition

In summary, Tempest Therapeutics' value proposition stems from:

• Proprietary platform for identifying and characterizing novel cancer targets in women's cancers
• Pipeline of precision medicines designed to target specific molecular alterations
• Address significant unmet medical needs in gynecological and breast cancers
• Promising clinical data demonstrating efficacy and safety
• Strategic partnerships and collaborations
• Strong intellectual property position
• Patient-centric approach focused on improving outcomes for women with cancer

Financial Risk

• Limited operating history: Tempest Therapeutics is a relatively new company with limited operating history. This means that there is less data available to assess its financial performance and stability.
• Dependence on a single product: Tempest Therapeutics is developing a single product candidate, TPST-1120. The company's financial success is largely dependent on the success of this product. If TPST-1120 fails to meet expectations or is not approved for commercial use, it could have a significant negative impact on the company's financials.
• Competition: Tempest Therapeutics faces competition from other companies developing therapies for the treatment of cancer. If these competitors develop more effective or less expensive therapies, it could reduce demand for TPST-1120 and negatively impact the company's financial performance.

Clinical Risk

• Phase II clinical trials: TPST-1120 is currently in Phase II clinical trials. These trials are designed to assess the safety and efficacy of the drug in a small group of patients. There is no guarantee that TPST-1120 will be successful in these trials or that it will be approved for commercial use.
• Manufacturing challenges: Tempest Therapeutics will need to develop a manufacturing process for TPST-1120 if it is approved for commercial use. This process will need to be scalable and cost-effective in order to meet demand for the drug. If Tempest Therapeutics is unable to develop a successful manufacturing process, it could delay or prevent the commercialization of TPST-1120.

Regulatory Risk

• FDA approval: TPST-1120 will need to be approved by the FDA before it can be marketed and sold in the United States. There is no guarantee that the FDA will approve TPST-1120, even if it is successful in clinical trials. The FDA may require additional studies or data before it approves the drug.
• Regulatory changes: The FDA and other regulatory agencies may change their regulations or requirements for the development and approval of new drugs. These changes could delay or prevent the commercialization of TPST-1120.

Overall Risk

The overall risk of investing in Tempest Therapeutics is high. The company is a relatively new company with limited operating history and is dependent on a single product candidate. The clinical trials for TPST-1120 are still ongoing and there is no guarantee that the drug will be successful or approved for commercial use. The company also faces competition from other companies developing therapies for the treatment of cancer and is subject to regulatory risk.