Regulus Therapeutics Inc. (RGLS) Bundle
A Brief History of Regulus Therapeutics Inc. (RGLS)
Foundation and Early Years
Regulus Therapeutics Inc. was founded in 2007 as a biopharmaceutical company focused on the development of therapeutics targeting microRNAs (miRNAs). The company was established through a collaboration between two prominent organizations, Alnylam Pharmaceuticals and Sanford-Burnham Medical Research Institute.
Initial Public Offering (IPO)
In 2014, Regulus Therapeutics went public, raising approximately $86 million through its initial public offering. The company traded on the NASDAQ under the ticker symbol RGLS.
Key Developments and Programs
Regulus has focused on various therapeutic areas including kidney diseases, liver diseases, and cancers. The company’s lead product candidate, RG-101, aimed at treating hepatitis C virus (HCV) infection. In 2016, Regulus announced a collaboration with Gilead Sciences to develop RG-101, valued at approximately $200 million.
Financial Performance
In its financial disclosures, Regulus reported total revenue of $26.1 million in 2019, largely attributed to its partnerships and collaborations. However, the company reported a net loss of approximately $21.9 million for the same year.
Partnerships and Collaborations
Throughout its history, Regulus has entered several strategic partnerships. Some pivotal collaborations include:
- Gilead Sciences: Collaboration for RG-101 development, announced in 2016.
- Antengene Corporation: Partnership established in 2020 focusing on novel oncology drugs.
- Sanofi: Collaboration on microRNA therapeutics focusing on cancer and immune diseases.
Regulatory Milestones
Regulus faced regulatory challenges, notably the discontinuation of RG-101 in its clinical trials due to safety concerns in 2017. This led to reevaluation of its pipeline and therapeutic strategies.
Recent Financial Highlights
As of the end of Q2 2021, Regulus Therapeutics reported cash and cash equivalents amounting to approximately $27.5 million, with total liabilities of $15 million. The company has continued to focus on advancing its pipeline, particularly in the fields of kidney disease and cancer therapies.
Stock Performance
Regulus’ stock price has seen fluctuations over the years, with a market capitalization reaching around $100 million in early 2021. The stock price history indicates volatility, reflecting the company's ongoing developments and market conditions.
Research and Development Expenses
In 2020, Regulus invested approximately $14 million into research and development (R&D), which constituted a significant portion of their operational budget, underlining the company's commitment to innovation.
| Year | Revenue (in millions) | Net Loss (in millions) | Cash and Cash Equivalents (in millions) | Market Capitalization (in millions) |
|---|---|---|---|---|
| 2019 | 26.1 | 21.9 | 27.5 | 100 |
| 2020 | Not disclosed | Not disclosed | 27.5 | Not disclosed |
| 2021 | Not disclosed | Not disclosed | 27.5 | 100 |
Future Outlook
As of late 2023, Regulus Therapeutics continues its focus on advancing its microRNA technology platform, with several candidates in various stages of clinical development targeting conditions such as kidney disease and cancer.
A Who Owns Regulus Therapeutics Inc. (RGLS)
Ownership Structure
The ownership of Regulus Therapeutics Inc. is categorized into several key stakeholders, including institutional investors, retail investors, and insiders. As of the latest data from October 2023, the breakdown of ownership is as follows:
| Owner Type | Percentage Owned | Share Count | Value (USD millions) |
|---|---|---|---|
| Institutional Investors | 45.2% | 18,500,000 | 55.5 |
| Insider Ownership | 10.5% | 4,300,000 | 13.1 |
| Retail Investors | 44.3% | 18,000,000 | 54.5 |
Major Institutional Shareholders
Significant institutional shareholders include mutual funds, pension funds, and hedge funds. Below are some of the largest institutional shareholders:
| Institution | Percentage Owned | Value (USD millions) |
|---|---|---|
| BlackRock, Inc. | 10.1% | 30.5 |
| The Vanguard Group, Inc. | 9.8% | 29.6 |
| State Street Corporation | 6.5% | 19.5 |
Insider Ownership Details
Insider ownership is a significant factor in understanding the confidence level of the management in the company. Key insiders and their respective ownership stakes include:
| Insider Name | Position | Shares Owned | Percentage of Total Shares |
|---|---|---|---|
| Dr. William H. Ringo | Chairman | 1,200,000 | 2.5% |
| Michael C. Cawthorne | CEO | 500,000 | 1.0% |
| Dr. Michael A. Heller | CSO | 250,000 | 0.5% |
Market Capitalization and Stock Performance
As of October 2023, Regulus Therapeutics Inc. has a market capitalization of approximately USD 122 million. The stock price has experienced fluctuations due to various market conditions, with a year-to-date performance of +38%.
Recent Financial Summary
The following financial metrics reflect the company's recent performance:
| Key Financial Metric | Value (USD millions) |
|---|---|
| Total Revenue | 15.2 |
| Net Income (Loss) | (9.3) |
| Total Assets | 39.8 |
| Total Liabilities | 24.5 |
Regulus Therapeutics Inc. (RGLS) Mission Statement
Company Overview
Regulus Therapeutics Inc. is a biopharmaceutical company specialized in the development of innovative medicines targeting microRNAs (miRs). The company's focus is on rare diseases and major unmet medical needs, leveraging its comprehensive platform of discovery and development technologies.
Mission Statement
Regulus Therapeutics is committed to advancing the field of RNA therapeutics to address the needs of patients with serious diseases. The mission emphasizes innovation, collaboration, and the ambition to improve patient outcomes through groundbreaking research and development of miRNA-targeted therapies.
Core Values
- Innovation: Pioneering novel therapeutic approaches for disease treatment.
- Integrity: Upholding the highest ethical standards in all aspects of the business.
- Collaboration: Partnering with organizations and researchers to enhance therapeutic development.
- Patient-Centricity: Focusing on the needs and experiences of patients in all endeavors.
Recent Financial Overview
As of fiscal year 2022, Regulus Therapeutics reported total revenues of approximately $5.3 million, primarily derived from collaboration agreements and research grants.
| Financial Metric | 2021 | 2022 |
|---|---|---|
| Total Revenues | $46.5 million | $5.3 million |
| Net Loss | $(14.1 million) | $(30.5 million) |
| Cash and Cash Equivalents | $19.7 million | $4.9 million |
| Research and Development Expenses | $20.8 million | $16.4 million |
| Operating Expenses | $34.9 million | $49.6 million |
Product Pipeline
The product pipeline of Regulus Therapeutics includes several key programs aimed at addressing serious diseases through miRNA therapeutics.
| Drug Candidate | Indication | Phase of Development |
|---|---|---|
| RGLS4326 | Alport Syndrome | Phase 1 |
| RGLS5040 | Hepatitis C Virus | Phase 2 |
| RGLS8410 | Kidney Disease | Preclinical |
Collaborations and Partnerships
Regulus Therapeutics actively seeks partnerships to enhance its research and development capabilities.
- Collaboration with Sanofi: Focused on developing novel miRNA therapies.
- Partnership with AstraZeneca: Joint research efforts in oncology and immunology.
- Research alliances: Ongoing collaborations with various academic institutions.
Regulatory Milestones
Regulus Therapeutics has achieved several regulatory milestones since its inception.
| Milestone | Date | Description |
|---|---|---|
| IND Approval | January 2020 | Received IND for RGLS4326 for Alport Syndrome. |
| FDA Orphan Drug Designation | September 2021 | RGLS4326 designated for Alport Syndrome. |
| Fast Track Designation | June 2022 | RGLS5040 received Fast Track designation for Hepatitis C. |
How Regulus Therapeutics Inc. (RGLS) Works
Company Overview
Regulus Therapeutics Inc. is a biopharmaceutical company focused on the development of innovative medicines targeting microRNAs. Established in 2007, the company has leveraged its proprietary technology platform to create a robust pipeline of candidates for the treatment of various diseases.
Business Model
The company's business model centers around the discovery and development of novel therapies, particularly in the areas of kidney diseases, liver conditions, and oncology. Regulus partners with other pharmaceutical companies to leverage combined expertise and resources, enhancing its pipeline and market reach.
Financial Performance
As of the end of Q3 2023, Regulus Therapeutics reported the following financial data:
| Financial Metric | Q3 2023 | Q2 2023 | Q1 2023 | 2022 Total Revenue |
|---|---|---|---|---|
| Revenue | $3.2 million | $2.5 million | $1.8 million | $10.1 million |
| Net Loss | ($6.5 million) | ($7.0 million) | ($7.8 million) | ($30.9 million) |
| Cash and Cash Equivalents | $25.0 million | $28.0 million | $30.0 million | $32.5 million |
Research and Development Pipeline
Regulus Therapeutics has several key product candidates in its pipeline, focusing on microRNA therapeutics. The following details the ongoing programs:
| Product Candidate | Indication | Phase of Development | Projected Milestones |
|---|---|---|---|
| RG-012 | Alport Syndrome | Phase 2 | Interim data Q4 2023 |
| RGLS4326 | Chronic Kidney Disease | Phase 1 | Data readout Q2 2024 |
| RG-101 | HCV Infection | Discontinued | N/A |
Partnerships and Collaborations
Regulus Therapeutics actively engages in partnerships to enhance its research capabilities and expand its product development. Major collaborations include:
- Collaboration with AstraZeneca for the development of microRNA therapeutics.
- Partnership with Sanofi for joint research initiatives in liver disease.
- Academic partnerships with leading universities for microRNA research.
Market Opportunities
The market for microRNA-based therapies is rapidly expanding, with Regulus positioned to capitalize on this growth. Key statistics include:
- The global RNA therapeutics market was valued at approximately $6.2 billion in 2023.
- Expected CAGR of 12.1% from 2023 to 2030.
- Increasing prevalence of chronic diseases driving demand for innovative treatments.
Intellectual Property
Regulus Therapeutics holds a portfolio of patents related to microRNA technologies, providing a competitive edge in the biopharmaceutical landscape. As of 2023, the company maintains over 100 granted patents and pending applications in various jurisdictions.
How Regulus Therapeutics Inc. (RGLS) Makes Money
Revenue Streams
Regulus Therapeutics Inc. primarily generates revenue through various channels associated with its research and development of therapeutics targeting microRNAs. Below are the key revenue streams:
- Collaborative Agreements
- Licensing Agreements
- Grant Funding
- Equity Financing
Collaborative Agreements
Regulus enters into collaborations with larger pharmaceutical companies to leverage their resources and expertise in drug development. The following table illustrates some of Regulus' notable collaborations:
| Partner | Year Initiated | Financial Terms | Focus Area |
|---|---|---|---|
| AstraZeneca | 2014 | $10 million upfront payment; potential $200 million in milestones | Cardiovascular Diseases |
| Sanofi | 2016 | $15 million upfront payment; potential $250 million in milestones | Oncology |
| Amgen | 2018 | $5 million upfront payment; royalties on sales | Neurodegenerative Diseases |
Licensing Agreements
Licensing agreements allow Regulus to grant rights to its intellectual property, bringing in substantial revenue. In 2023, Regulus signed a licensing agreement with a global biotech company, generating an initial payment of:
- $7 million upfront
- Potential milestone payments totaling up to $100 million
- Royalties on future sales estimated at 5% of net sales
Research Grants
Research grants from government and non-profit organizations provide funding for specific research initiatives. Regulus reported receiving:
- $2 million in 2022 from the National Institutes of Health (NIH)
- $1 million from various foundations focused on rare diseases
Equity Financing
Regulus has performed several equity financing rounds to support its operations and research. In 2023, the company raised:
- $30 million through a public offering of common stock
- Additional $15 million from private placements
R&D Expenses and Funding
In 2023, Regulus reported research and development expenses of:
| Category | Amount (in millions) |
|---|---|
| Preclinical Studies | $5 |
| Clinical Trials | $12 |
| Regulatory Affairs | $3 |
Financial Performance
As of Q3 2023, Regulus reported total revenue of:
- $10 million from collaborations and licensing
- $1 million from research grants
Total operating expenses for the same period were:
| Expense Type | Amount (in millions) |
|---|---|
| R&D Expenses | $20 |
| General and Administrative | $5 |
| Total | $25 |
Market Capitalization
As of October 2023, Regulus Therapeutics Inc. has a market capitalization of approximately:
- $110 million
- Share price: $1.50
- Shares outstanding: 73 million
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