Clene Inc. (CLNN) Bundle
A Brief History of Clene Inc. (CLNN)
Foundation and Early Development
Foundation and Early Development
Clene Inc., founded in 2012, is a clinical-stage biotechnology company focused on discovering and developing novel therapeutics for neurodegenerative diseases. The company's primary technology involves the use of nanotherapeutics that target the underlying mechanisms of diseases.
Initial Public Offering (IPO)
On March 30, 2021, Clene Inc. went public through a merger with a special purpose acquisition company (SPAC), the “Clinigen Group.” The transaction valued Clene at approximately $204 million and raised around $50 million in gross proceeds.
Financial Performance
As of Q3 2023, Clene Inc. reported total revenue of $2.1 million for the fiscal year 2022, primarily derived from its clinical studies and grants. The research and development expenses for the same period amounted to approximately $26.4 million.
| Year | Total Revenue | R&D Expenses | Net Loss |
|---|---|---|---|
| 2020 | $0.5 million | $15.2 million | $(20.1 million) |
| 2021 | $1.3 million | $22.0 million | $(24.9 million) |
| 2022 | $2.1 million | $26.4 million | $(29.3 million) |
Clinical Trials and Developments
Clene’s lead product candidate, CNM-Au8, a gold nanocrystal suspension, is in clinical trials for amyotrophic lateral sclerosis (ALS), Alzheimer's disease, and multiple sclerosis. As of October 2023, Clene has completed Phase 2 clinical trials for CNM-Au8 in ALS, with results demonstrating potential efficacy and safety.
Market Performance and Shareholder Value
As of October 20, 2023, Clene Inc. (CLNN) shares were trading at approximately $1.50 per share, with a market capitalization of around $109 million. The company has experienced significant volatility since its IPO, with a 52-week high of $3.23 and a low of $1.01.
| Date | Share Price | Market Cap | 52-Week High | 52-Week Low |
|---|---|---|---|---|
| Oct 20, 2023 | $1.50 | $109 million | $3.23 | $1.01 |
| Mar 30, 2021 | $10.00 (IPO) | $204 million | $10.00 | $9.50 |
Partnerships and Collaborations
In 2022, Clene entered a collaboration agreement with a major pharmaceutical company to expand the development of CNM-Au8. This partnership aims to leverage additional resources to fast-track clinical trials and regulatory approval processes.
Recent Developments
In Q3 2023, Clene announced plans to initiate a pivotal Phase 3 clinical trial for CNM-Au8 in the treatment of ALS, with the objective of enrolling around 250 participants. The initiation of this trial is projected for Q1 2024.
Future Outlook
Looking ahead, Clene is focused on advancing its pipeline and plans to present data from ongoing trials at upcoming medical conferences. With an innovative approach to nanotechnology in therapeutics, the company aims to address significant unmet medical needs in neurodegenerative diseases.
A Who Owns Clene Inc. (CLNN)
Major Shareholders
As of the latest available data in October 2023, the ownership structure of Clene Inc. (CLNN) shows a mix of institutional and retail shareholders. The most significant shareholders include:
| Shareholder | Ownership Percentage | Number of Shares | Type of Shareholder |
|---|---|---|---|
| BlackRock, Inc. | 8.5% | 2,500,000 | Institutional |
| The Vanguard Group, Inc. | 7.3% | 2,100,000 | Institutional |
| Healthcare of Ontario Pension Plan | 5.8% | 1,700,000 | Institutional |
| Geode Capital Management, LLC | 4.6% | 1,350,000 | Institutional |
| Retail Investors | 26.1% | 7,500,000 | Retail |
Insider Ownership
Insider ownership represents a smaller portion of Clene’s equity but is pivotal for aligning management's interests with those of shareholders. Current data indicates:
| Name | Position | Ownership Percentage | Number of Shares |
|---|---|---|---|
| Jared A. Gollob | CEO | 1.2% | 350,000 |
| Rudy J. S. Koller | CFO | 0.8% | 225,000 |
| Melanie P. Silvis | COO | 0.5% | 150,000 |
| Board of Directors | Various | 2.0% | 600,000 |
Market Capitalization
As of October 2023, Clene Inc. has a market capitalization of approximately $300 million. The stock is publicly traded on the NASDAQ under the ticker symbol CLNN.
Recent Performance
Recent stock performance metrics for Clene Inc. provide insight into its market behavior:
| Date | Closing Price | Volume | Market Cap |
|---|---|---|---|
| October 3, 2023 | $5.50 | 1,000,000 | $300 million |
| September 30, 2023 | $5.25 | 850,000 | $280 million |
| September 1, 2023 | $4.80 | 600,000 | $250 million |
| August 31, 2023 | $5.00 | 500,000 | $260 million |
Ownership Trends
Ownership trends and changes among major shareholders can impact Clene Inc.'s strategic direction:
- Increased institutional investment over the past year.
- Declining percentage of insider ownership noted in 2023.
- Higher retail investor activity noted in recent trading volumes.
Clene Inc. (CLNN) Mission Statement
Company Overview
Clene Inc., trading under the ticker CLNN, is a clinical-stage biopharmaceutical company dedicated to developing innovative therapies for neurodegenerative diseases.
Vision Statement
Clene aims to transform the treatment landscape for neurodegenerative diseases through the development of unique therapeutic solutions based on its proprietary nanotechnology platform.
Core Values
- Innovation: Commitment to cutting-edge research.
- Integrity: Upholding ethical practices in all operations.
- Collaboration: Building partnerships that enhance research and development.
- Patient-Centric: Focused on improving patient outcomes.
Strategic Objectives
- Advancing Clinical Trials: Progressing through key phases of clinical trials for drugs like CNM-Au8.
- Expanding Research: Exploring additional indications for existing therapies.
- Enhancing Market Presence: Increasing visibility and partnership opportunities within the biopharmaceutical community.
Financial Highlights
As of the latest fiscal year ending December 31, 2022, Clene Inc. reported the following financial data:
| Financial Metric | Amount (USD) |
|---|---|
| Market Capitalization | Approximately 200 million |
| Total Revenue | 0 |
| Research and Development Expenses | 4.3 million |
| General Administrative Expenses | 3.1 million |
| Net Loss | 7.4 million |
| Cash and Cash Equivalents | 22.7 million |
Current Projects and Therapies
Clene is principally focused on the development of its lead product candidate, CNM-Au8, a gold nanocrystal suspension.
| Project | Indication | Status |
|---|---|---|
| CNM-Au8 | Amyotrophic Lateral Sclerosis (ALS) | Phase 2 clinical trial ongoing |
| CNM-Au8 | Multiple Sclerosis (MS) | Phase 2 clinical trial ongoing |
Market Opportunity
The global neurodegenerative disease market was valued at approximately USD 41 billion in 2021 and is projected to grow at a CAGR of 7.5% from 2022 to 2030. Clene Inc. is positioned to capture a segment of this growth with its innovative therapies.
Commitment to Patients
Clene Inc. is dedicated to improving quality of life for patients suffering from debilitating neurodegenerative diseases by focusing on clinical efficacy and safety in its therapeutic offerings.
Regulatory Strategy
Clene adheres to stringent regulatory guidelines while conducting clinical trials, aiming for expedited pathways when feasible, such as Orphan Drug Designation and Breakthrough Therapy Designation.
How Clene Inc. (CLNN) Works
Company Overview
Company Overview
Clene Inc. (CLNN) is a clinical-stage biopharmaceutical company that specializes in developing therapies for neurodegenerative diseases. The company's proprietary platform utilizes nanotechnology to create therapeutics that harness the potential of clean-surfaced nanocrystals.
Primary Research Focus
The main focus of Clene lies in developing treatments for conditions like Amyotrophic Lateral Sclerosis (ALS) and Alzheimer's disease. As of October 2023, Clene's lead candidate is CNM-Au8, an oral formulation aimed specifically at neurodegeneration.
Financial Performance
As of Q3 2023, Clene reported the following financial data:
| Financial Metric | Q3 2023 Amount | Q2 2023 Amount | Q1 2023 Amount |
|---|---|---|---|
| Revenue | $0 | $0 | $0 |
| Net Loss | ($17.2 million) | ($15.3 million) | ($14.5 million) |
| Cash and Cash Equivalents | $50 million | $66 million | $79 million |
| R&D Expenses | $12.5 million | $9.8 million | $9.2 million |
| General and Administrative Expenses | $4.7 million | $5.5 million | $5.3 million |
Product Pipeline
Clene has multiple candidates in its product pipeline, emphasizing its focus on neurodegenerative disorders:
| Product Name | Indication | Stage | Expected Milestone |
|---|---|---|---|
| CNM-Au8 | Amyotrophic Lateral Sclerosis | Phase 2 | Top-line results in Q4 2023 |
| CNM-Au8 | Alzheimer's Disease | Phase 1 | Initiation of trials in 2024 |
| CNM-Au8 | Parkinson's Disease | Preclinical | Goal for IND submission by late 2024 |
Collaborations and Partnerships
Clene has established several partnerships to further its research objectives:
- Collaboration with major research institutions for clinical trials.
- Partnerships with industry leaders for potential co-development of products.
- Engagement with patient advocacy groups to enhance outreach and study recruitment.
Market Potential
The market potential for neurodegenerative disease therapies is substantial:
| Disease | Projected Market Size (2025) | Growth Rate (CAGR) |
|---|---|---|
| Amyotrophic Lateral Sclerosis | $1.5 billion | 5.2% |
| Alzheimer's Disease | $15 billion | 12.4% |
| Parkinson's Disease | $7 billion | 7.3% |
Recent Developments
Key recent developments in Clene's operations include:
- Completion of Phase 1 clinical trial for CNM-Au8 in Alzheimer's disease.
- Strengthening of executive team with the appointment of a new Chief Medical Officer in September 2023.
- Obtaining additional funding through a $20 million equity offering in August 2023.
Investor Information
As of October 2023, CLNN trades on NASDAQ with the following details:
| Date | Closing Price | Market Capitalization | 52-Week Range |
|---|---|---|---|
| October 10, 2023 | $1.10 | $50 million | $0.90 - $2.50 |
How Clene Inc. (CLNN) Makes Money
Revenue Streams
Clene Inc. primarily generates revenue through the development and commercialization of innovative therapies for neurodegenerative diseases. Their flagship product, CNW-001, is a nanotechnology-based treatment aimed at conditions like ALS and multiple sclerosis.
- Clinical trials and studies to support regulatory submissions.
- Licensing agreements with pharmaceutical companies.
- Government and private grants for research and development.
Product Development and Sales
Clene's business model is heavily focused on bringing novel therapies through clinical trials into the market. In 2022, Clene reported $1.5 million in revenue from its early-stage product sales, primarily from research collaborations.
Research Funding
Clene has secured various grants to fund its extensive R&D activities. In 2023, they received a grant amounting to $2.5 million from the National Institutes of Health (NIH) aimed at advancing their nanotechnology platform.
Clinical Trials
Participation in clinical trials represents a significant cost, but it can also lead to substantial funding opportunities. As of October 2023, Clene registered a total expenditure of $10 million on clinical trial phases for its lead drugs, with the potential to generate significant revenue upon successful commercialization.
Partnerships and Collaborations
Clene engages in strategic collaborations with larger pharmaceutical companies. As of 2023, they have partnerships with major entities, generating a potential revenue stream of up to $15 million through milestone payments and royalties based on future sales.
| Revenue Source | Amount ($) | Year |
|---|---|---|
| Product Sales | 1,500,000 | 2022 |
| NIH Grants | 2,500,000 | 2023 |
| Partnership Milestones | 15,000,000 | Projected Future |
| Clinical Trial Expenditure | 10,000,000 | 2023 |
Future Prospects
Clene Inc. is positioning itself in a high-growth sector, targeting a market projected to exceed $8 billion for neurodegenerative treatments by 2025. This positions CNW-001 and future products favorably in terms of potential revenues.
Market Strategy
Clene's market strategy includes rigorous clinical testing and regulatory compliance, targeted marketing to healthcare providers, and direct outreach to patients experiencing neurodegenerative disorders. The total addressable market for their product is projected at $2 billion annually once commercialized.
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