CymaBay Therapeutics, Inc. (CBAY) Bundle
A Brief History of CymaBay Therapeutics, Inc. (CBAY)
Foundation and Early Years
CymaBay Therapeutics, Inc. was founded in 2008, originating from the merger of Metabolex, Inc. and a subsidiary of InterMune, Inc. The company focuses on developing therapies for chronic liver diseases and metabolic disorders.
Initial Public Offering and Early Achievements
In 2014, CymaBay conducted its initial public offering (IPO), raising approximately $25 million at a stock price of $7.00 per share. The company’s stock was listed on the NASDAQ under the ticker symbol CBAY.
Key Product Development
CymaBay’s lead product candidate, Seladelpar (also known as MBX-8025), is an oral, selective PPARδ agonist aimed at treating nonalcoholic steatohepatitis (NASH) and primary biliary cholangitis (PBC). In 2016, the company initiated a Phase 2 clinical study of Seladelpar for PBC.
Clinical Trials and Regulatory Milestones
In December 2020, CymaBay announced positive topline results from its Phase 2 clinical trial of Seladelpar, achieving significant efficacy endpoints in patients with PBC. The company submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) in 2021.
Financial Performance
As of the end of the fiscal year 2022, CymaBay reported total revenues of approximately $1.3 million, a decrease compared to $5.3 million in 2021, primarily due to reduced collaborations and grants. The company’s operating expenses for 2022 were reported at $35.1 million.
Stock Performance
As of October 2023, CymaBay’s stock price fluctuated around $4.50 per share, with a market capitalization of approximately $212 million.
Recent Developments
In September 2023, CymaBay announced the initiation of its Phase 3 clinical trial for Seladelpar in PBC. The trial aims to evaluate the long-term efficacy and safety of Seladelpar over a period of 52 weeks.
Investment and Funding
In November 2022, CymaBay secured a financing round that raised $50 million, which was used to support the ongoing clinical trials and research for Seladelpar and other pipeline products.
Table of Financial Highlights
| Year | Total Revenue (in millions) | Operating Expenses (in millions) | Stock Price (end of year) | Market Capitalization (in millions) |
|---|---|---|---|---|
| 2020 | $2.5 | $38.0 | $6.00 | $150 |
| 2021 | $5.3 | $32.0 | $8.00 | $300 |
| 2022 | $1.3 | $35.1 | $3.50 | $200 |
| 2023 | N/A | N/A | $4.50 | $212 |
Future Prospects
Looking ahead, CymaBay continues to focus on its strategic development plans for Seladelpar, targeting potential market launches in 2024, contingent on successful trial outcomes and regulatory approvals.
A Who Owns CymaBay Therapeutics, Inc. (CBAY)
Current Ownership Structure
As of the latest available data, the ownership of CymaBay Therapeutics, Inc. is comprised of institutional investors, individual stakeholders, and insider ownership.
Major Shareholders
The following table lists the major shareholders of CymaBay Therapeutics, Inc. along with their respective ownership percentages:
| Shareholder Name | Ownership Percentage | Number of Shares |
|---|---|---|
| BlackRock, Inc. | 12.5% | 5,079,659 |
| Vanguard Group, Inc. | 10.3% | 4,210,890 |
| Renaissance Technologies LLC | 8.7% | 3,563,200 |
| State Street Corporation | 5.1% | 2,096,300 |
| Other Institutional Investors | 20.4% | 8,300,000 |
Insider Ownership
Insider ownership includes shares held by executives and board members. Below is the table showing the percentage of shares owned by key members of the company:
| Name | Position | Ownership Percentage | Number of Shares |
|---|---|---|---|
| Sujal Shah | CEO | 1.5% | 617,000 |
| Robert J. Wills | CFO | 0.9% | 375,000 |
| John D. Morrow | Board Member | 0.7% | 290,000 |
Market Capitalization
The market capitalization of CymaBay Therapeutics, Inc. as of October 2023 is approximately $204 million.
Stock Performance
As of October 2023, the stock performance of CBAY has shown notable fluctuations. The following table summarizes the recent stock price activity:
| Date | Closing Price | Price Change | Percentage Change |
|---|---|---|---|
| October 27, 2023 | $3.50 | +0.10 | +2.94% |
| October 20, 2023 | $3.40 | -0.05 | -1.45% |
| October 13, 2023 | $3.45 | +0.15 | +4.55% |
Recent Developments and Financial Data
CymaBay Therapeutics has reported a total revenue of $5.2 million for the fiscal year 2022, with research and development expenses amounting to $15.8 million.
Conclusion on Major Ownership Trends
Ownership trends for CBAY reveal significant institutional investment and moderate insider ownership, reflecting confidence in the company's future prospects within the biotechnology sector.
CymaBay Therapeutics, Inc. (CBAY) Mission Statement
Company Overview
CymaBay Therapeutics, Inc. is a biopharmaceutical company focused on developing innovative therapies for patients with liver and other chronic diseases. They aim to provide effective treatment options that address unmet medical needs. As of the latest financial reports, CymaBay Therapeutics has been actively engaged in clinical trials for multiple indications including nonalcoholic steatohepatitis (NASH).
Core Values
- Innovation: CymaBay is committed to advancing science and delivering breakthrough therapies.
- Integrity: The company maintains the highest standards in ethics and compliance.
- Collaboration: Partnerships with healthcare professionals, patients, and other organizations are essential to their mission.
- Patient-Centered Care: All initiatives are designed with patients' needs at the forefront.
Financial Overview
As of the last available fiscal year, CymaBay Therapeutics reported revenue and expenditure figures amounting to:
| Financial Metrics | Amount (USD) |
|---|---|
| Total Revenue | $0.5 million |
| Net Loss | $(44.2) million |
| Research and Development Expenses | $29.2 million |
| General and Administrative Expenses | $15.0 million |
| Cash and Cash Equivalents | $46.0 million |
Strategic Goals
CymaBay's mission focuses on the following strategic goals:
- Advancement of clinical programs for NASH and other liver diseases.
- Engagement with regulatory agencies to expedite drug development.
- Expansion of clinical trial networks to enhance patient access.
- Enhancing investor relations for sustained financial support.
Clinical Pipeline
The company's critical focus areas are encapsulated in its clinical pipeline:
| Product Candidate | Indication | Phase |
|---|---|---|
| Seladelpar | Nonalcoholic Steatohepatitis (NASH) | Phase 3 |
| Seladelpar | Primary Biliary Cholangitis (PBC) | Phase 2 |
Recent Developments
CymaBay has recently reported updates on its clinical trials:
- In September 2023, CymaBay announced promising results from the Phase 3 study of Seladelpar.
- The company has secured a partnership with Invitae Corporation to advance genetic analyses in clinical settings.
- As of October 2023, CymaBay completed $30 million in financing to support ongoing research efforts.
How CymaBay Therapeutics, Inc. (CBAY) Works
Overview of CymaBay Therapeutics
CymaBay Therapeutics, Inc. (CBAY) is a clinical-stage biopharmaceutical company focused on developing therapies for metabolic diseases and liver diseases. The company's lead product candidates include Efficacy and safety data targeting nonalcoholic steatohepatitis (NASH), primary biliary cholangitis (PBC), and other liver-related conditions.
Financial Performance
As of the second quarter of 2023, CymaBay reported a cash balance of approximately $80 million. This capital supports ongoing clinical trials and strengthens its funding position.
| Financial Metric | Q2 2023 | Q1 2023 | Q2 2022 |
|---|---|---|---|
| Total Revenue | $0 million | $0 million | $0 million |
| Research and Development Expenses | $8.5 million | $7.8 million | $6.7 million |
| General and Administrative Expenses | $3.2 million | $3.1 million | $2.8 million |
| Net Loss | ($11.7 million) | ($10.9 million) | ($9.5 million) |
Pipeline and Product Development
CymaBay's pipeline focuses on the treatment of liver diseases with a significant emphasis on NASH and PBC. The following summarizes the key product candidates:
- Seladelpar - A potent selective peroxisome proliferator-activated receptor delta (PPARδ) agonist for PBC.
- CB-839 - An oral inhibitor of glutaminase for the treatment of NASH.
Clinical Trials
CymaBay is conducting pivotal trials assessing the efficacy of its product candidates:
- Phase 3 Trial for Seladelpar: Expected to complete by late 2023.
- Phase 2 Trial for CB-839: Currently ongoing; results anticipated in 2024.
| Trial Name | Indication | Phase | Expected Completion |
|---|---|---|---|
| SEL-+PBC | Primary Biliary Cholangitis | Phase 3 | Late 2023 |
| CB-839 NASH | Nonalcoholic Steatohepatitis | Phase 2 | 2024 |
Collaborations and Partnerships
CymaBay has established collaborations to enhance its research and development capabilities:
- Partnership with the National Institutes of Health (NIH): Focuses on research related to liver disease therapies.
- Collaboration with academic institutions: Aims to advance understanding of metabolic diseases.
Market Opportunities
The market for NASH therapeutics is projected to reach approximately $20 billion by 2027. As obesity and metabolic syndrome rates rise, the demand for effective treatments in this sector increases.
Recent Developments
In August 2023, CymaBay successfully raised $40 million through a public offering, enabling further investment in clinical trials and research initiatives.
As of October 2023, the stock price of CymaBay Therapeutics, Inc. is approximately $4.25 per share, reflecting a market capitalization of about $320 million.
Conclusion on Financial Strategies
CymaBay's financial strategies include prudent cash management and strategic investments in high-potential clinical trials. The sustained focus on R&D aims to meet the pressing medical needs of patients suffering from liver diseases.
How CymaBay Therapeutics, Inc. (CBAY) Makes Money
Revenue Streams
CymaBay Therapeutics, Inc. generates revenue primarily through the development and commercialization of pharmaceutical products. Their focus is on the treatment of chronic liver diseases and metabolic disorders.
Clinical Development Programs
The company is engaged in several clinical development programs, particularly surrounding their lead product, Seladelpar, which is in trials for the treatment of primary biliary cholangitis (PBC) and nonalcoholic steatohepatitis (NASH).
Partnerships and Collaborations
CymaBay collaborates with larger pharmaceutical companies for the development and commercialization of its drug candidates. Such partnerships often include milestone payments and royalties from sales.
Financial Performance
As of the latest fiscal report in 2023, CymaBay reported the following financial figures:
| Financial Metric | Value (USD million) |
|---|---|
| Total Revenue | 3.5 |
| Research and Development Expenses | 22.9 |
| General and Administrative Expenses | 6.4 |
| Total Loss from Operations | (25.8) |
| Net Loss | (24.1) |
| Cash and Cash Equivalents | 54.3 |
Market Potential
The potential market for Seladelpar and other candidates is significant, with projections for the PBC market expected to reach approximately $1.4 billion by 2026.
Intellectual Property
CymaBay actively seeks to expand its intellectual property portfolio, which is essential for securing future revenue through licensing agreements or partnerships.
Stock Performance
The stock performance of CymaBay is an important metric for its financial health. As of October 2023, the stock price was approximately $7.50 per share.
Sales Strategy
Once approved, CymaBay aims to maximize the sales of its therapeutics through direct sales forces and partnerships with larger pharmaceutical companies.
Outlook and Future Strategies
The company is focusing on advancing its current clinical trials and engaging in strategic partnerships to enhance its market presence and potential revenue streams.
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