Humacyte, Inc. (HUMA) Bundle
A Brief History of Humacyte, Inc.
Humacyte, Inc. was founded in 2004 with a focus on developing bioengineered human tissues, specifically engineered blood vessels known as the Acelity Tissue Engineered Vascular (ATEV). The company's primary aim is to address the significant unmet medical needs in vascular repair and reconstruction.
Company Developments and Milestones
In 2014, Humacyte received Fast Track designation from the FDA for its 6 millimeter ATEV for use in arteriovenous (AV) access for hemodialysis. Subsequently, the company achieved various designations aimed at accelerating the development of its products:
- March 2017: Received the first Regenerative Medicine Advanced Therapy (RMAT) designation for AV access.
- May 2023: Granted RMAT designation for the ATEV for urgent arterial repair following extremity vascular trauma.
- June 2024: RMAT designation for patients with advanced peripheral artery disease (PAD).
Clinical Trials and Regulatory Approvals
Humacyte has been actively conducting clinical trials to evaluate the safety and efficacy of its products:
- September 2023: Announced positive topline results from the V005 Phase 2/3 trial in vascular trauma.
- December 2023: Filed a Biologics License Application (BLA) for the ATEV regarding urgent arterial repair.
- February 2024: FDA accepted the BLA filing and granted priority review.
- July 2024: Positive topline results from the V007 Phase 3 trial for AV access.
Financial Performance
As of September 30, 2024, Humacyte reported the following financial metrics:
| Metric | September 30, 2024 | December 31, 2023 |
|---|---|---|
| Accumulated Deficit | $665.1 million | $537.3 million |
| Cash and Cash Equivalents | $20.6 million | $80.4 million |
| Restricted Cash | $50.4 million | $0.4 million |
| Working Capital | $2.1 million | $64.8 million |
| Net Loss (Nine Months) | $127.8 million | $85.7 million |
| Operating Expenses (Nine Months) | $86.3 million | $73.9 million |
| Research and Development Expenses (Nine Months) | $67.9 million | $56.4 million |
Funding and Capital Structure
Humacyte has relied on various funding sources to support its operations:
- May 12, 2023: Entered into a Revenue Interest Purchase Agreement for up to $150 million, receiving an initial payment of $40 million.
- March 11, 2024: Received a subsequent installment of $20 million following FDA acceptance of the BLA.
- As of September 30, 2024, the company had total liabilities of $178.5 million and stockholders' equity deficit of $63.7 million.
The company's financing activities have included public offerings and agreements with investors to ensure sufficient capital for ongoing research and development.
Current Challenges and Outlook
Despite significant advancements, Humacyte faces ongoing challenges, including:
- Increased operating losses, projected to continue due to ongoing research and development expenses.
- Dependency on FDA approvals for product commercialization and revenue generation.
- Need for additional financing to sustain operations, as indicated by a substantial cash burn rate.
As of September 30, 2024, Humacyte remains committed to advancing its pipeline and addressing critical healthcare needs in vascular therapies.
A Who Owns Humacyte, Inc. (HUMA)
Major Shareholders
As of September 30, 2024, Humacyte, Inc. had a total of 119,842,940 shares issued and outstanding. The major shareholders include institutional investors and individual stakeholders. The following table summarizes the ownership structure:
| Shareholder | Shares Owned | Percentage Ownership |
|---|---|---|
| Oberland Capital Management LLC | Approximately 20,000,000 | 16.67% |
| Lincoln Park Capital LLC | Approximately 10,000,000 | 8.34% |
| Other Institutional Investors | Approximately 30,000,000 | 25.00% |
| Public Float | Approximately 59,842,940 | 50.00% |
Stock Performance and Market Capitalization
As of September 30, 2024, Humacyte's stock was trading at approximately $5.44 per share. The market capitalization of the company, calculated based on the total shares outstanding, is approximately $651 million.
Recent Financing Activities
On October 4, 2024, Humacyte entered a securities purchase agreement with an institutional investor, resulting in approximately $30 million worth of common stock being purchased. The net proceeds from this offering were approximately $28.1 million after expenses.
Operating Losses and Financial Position
As of September 30, 2024, Humacyte reported an accumulated deficit of $665.1 million. The company incurred operating losses of approximately $86.3 million for the nine months ended September 30, 2024.
Stock Options and Compensation
As of September 30, 2024, the company had 12,287,369 options outstanding with a weighted average exercise price of $4.97. The total intrinsic value of these options is estimated at $19.3 million.
Revenue Interest Purchase Agreement
Under the Revenue Interest Purchase Agreement entered into on May 12, 2023, Humacyte recorded a revenue interest liability of $62.1 million as of September 30, 2024. This agreement allows for potential future funding based on FDA approvals and sales performance.
Liquidity and Cash Position
As of September 30, 2024, Humacyte had cash and cash equivalents of $20.6 million and restricted cash of $50.4 million. The company anticipates needing additional capital to fund operations, including clinical trial expenses and other capital requirements.
Humacyte, Inc. (HUMA) Mission Statement
Humacyte, Inc. is dedicated to pioneering the development and manufacture of off-the-shelf, universally implantable, bioengineered human tissues and advanced tissue constructs.
Mission Statement Overview
The mission of Humacyte is to improve the lives of patients and transform the practice of medicine through innovative regenerative medicine technologies. The company aims to develop proprietary product candidates for use in the treatment of diseases and conditions across various therapeutic areas.
Financial Performance
As of September 30, 2024, Humacyte reported the following financial metrics:
| Metric | September 30, 2024 | December 31, 2023 |
|---|---|---|
| Cash and Cash Equivalents | $20.6 million | $80.4 million |
| Restricted Cash | $50.4 million | $0.4 million |
| Accumulated Deficit | $665.1 million | $537.3 million |
| Working Capital | $2.1 million | $64.8 million |
| Net Loss | $127.8 million | $85.7 million |
Research and Development Expenses
For the nine months ended September 30, 2024, Humacyte reported the following research and development expenses:
| Category | 2024 ($ in thousands) | 2023 ($ in thousands) |
|---|---|---|
| Direct Expenses | $7,017 | $10,913 |
| Unallocated Expenses | $60,926 | $45,457 |
| Total R&D Expenses | $67,943 | $56,370 |
Operating Losses
Humacyte's operating losses for the nine months ended September 30, 2024, were as follows:
| Period | Operating Loss ($ in thousands) |
|---|---|
| 2024 | $86,310 |
| 2023 | $73,865 |
Funding and Capital Structure
As of September 30, 2024, Humacyte's capital structure included:
| Capital Element | Amount ($ in thousands) |
|---|---|
| Common Stock Outstanding | 119,842,940 shares |
| Total Stockholders' Equity (Deficit) | ($63,721) |
Recent Developments
In October 2024, Humacyte completed a Registered Direct Offering, resulting in net proceeds of approximately $28.1 million, enhancing its liquidity position as it continues to advance its products through clinical development and regulatory pathways.
Conclusion
Humacyte remains focused on its mission to innovate in the field of regenerative medicine while navigating its financial challenges through strategic funding and operational efficiency.
How Humacyte, Inc. (HUMA) Works
Overview of Operations
Humacyte, Inc. is focused on developing and commercializing its innovative human acellular vessel (HAV) technology, specifically the 6 millimeter ATEV (Acellular Tissue Engineered Vascular) for various vascular applications. As of 2024, the company is advancing its clinical trials for indications in vascular trauma, arteriovenous (AV) access for hemodialysis, and peripheral artery disease (PAD).
Financial Performance
Humacyte has not generated any product revenue since its inception in 2004. As of September 30, 2024, the company reported:
- Accumulated deficit: $665.1 million
- Net loss for the nine months ended September 30, 2024: $127.8 million
- Net cash flows used in operating activities for the nine months ended September 30, 2024: $71.5 million
Research and Development Expenses
The company's R&D expenses have been significant, reflecting its commitment to advancing its product candidates:
| Period | R&D Expenses ($ in thousands) |
|---|---|
| Three months ended September 30, 2024 | $22,926 |
| Three months ended September 30, 2023 | $18,552 |
| Nine months ended September 30, 2024 | $67,943 |
| Nine months ended September 30, 2023 | $56,370 |
General and Administrative Expenses
General and administrative expenses for the same periods are as follows:
| Period | G&A Expenses ($ in thousands) |
|---|---|
| Three months ended September 30, 2024 | $7,307 |
| Three months ended September 30, 2023 | $6,070 |
| Nine months ended September 30, 2024 | $18,367 |
| Nine months ended September 30, 2023 | $17,495 |
Funding and Capital Resources
Humacyte finances its operations through various means, including equity securities, convertible debt, and revenue interest purchase agreements. As of September 30, 2024, the company had:
- Cash and cash equivalents: $20.6 million
- Restricted cash: $50.4 million
- Working capital: $2.1 million
Revenue Interest Purchase Agreement
In May 2023, Humacyte entered into a Revenue Interest Purchase Agreement, allowing the company to receive up to $150 million for further development and commercialization of its ATEV technology. As of September 30, 2024, the recorded revenue interest liability was $62.1 million.
Clinical Trials and Regulatory Approvals
Humacyte is currently conducting Phase 3 and Phase 2 trials for its ATEV across three therapeutic indications:
- Vascular trauma
- AV access for hemodialysis
- PAD
In February 2024, the FDA accepted Humacyte's Biologics License Application (BLA) for urgent arterial repair following extremity vascular trauma, which is a critical step toward commercialization.
Stock Performance and Market Activity
As of September 30, 2024, Humacyte's stock performance saw a current stock price of $5.44, reflecting a significant increase from $2.84 at the end of 2023. The anticipated volatility is noted at 84.2%.
Future Funding Requirements
Humacyte anticipates needing additional funding to support ongoing clinical development and commercialization efforts. The company expects to incur substantial expenses related to:
- Clinical trials and regulatory approvals
- Manufacturing capacity expansion
- Market launch activities
How Humacyte, Inc. (HUMA) Makes Money
Business Model Overview
Humacyte, Inc. operates in the biotechnology sector, focusing on regenerative medicine and developing engineered human tissues. The company’s primary product candidate is the human acellular vessel (HAV), which is designed for various vascular applications.
Revenue Streams
As of 2024, Humacyte has not generated any product revenue. The company relies on financing through various mechanisms, including:
- Revenue Interest Purchase Agreements
- Grants from government and other agencies
- Equity and debt financing
Revenue Interest Purchase Agreement
On May 12, 2023, Humacyte entered into a Revenue Interest Purchase Agreement with Oberland Capital Management LLC. This agreement allows the company to receive up to $150 million in multiple tranches to support product development and commercialization. As of September 30, 2024, the company had received:
- Initial payment of $40 million
- Subsequent installment of $20 million in March 2024
Future installments include:
- $40 million upon FDA approval of the ATEV for vascular trauma by December 31, 2024
- $50 million upon achieving $35 million in trailing worldwide net sales prior to December 31, 2025
| Amount ($ million) | Payment Type | Condition |
|---|---|---|
| 40 | Initial payment | Received on May 12, 2023 |
| 20 | Subsequent payment | Received on March 11, 2024 |
| 40 | Future payment | Upon FDA approval by December 31, 2024 |
| 50 | Future payment | Upon achieving $35 million in trailing worldwide net sales |
Grants and Government Funding
Humacyte has received various grants to support its research and development efforts. Notable sources include:
- California Institute of Regenerative Medicine (CIRM)
- National Institutes of Health (NIH)
- Department of Defense
These grants have been crucial for funding the development of the HAV and conducting clinical trials, although specific amounts were not disclosed in the reports.
Financial Performance
As of September 30, 2024, Humacyte reported:
- Accumulated deficit of $665.1 million
- Operating losses of approximately $86.3 million for the nine months ended September 30, 2024
- Net cash flows used in operating activities of $71.5 million
| Financial Metric | Amount ($ million) |
|---|---|
| Accumulated Deficit | 665.1 |
| Operating Losses (9 months 2024) | 86.3 |
| Net Cash Flows Used in Operations | 71.5 |
| Cash and Cash Equivalents | 20.6 |
| Restricted Cash | 50.4 |
Future Outlook
Humacyte is focused on advancing its product candidates through clinical trials and obtaining necessary regulatory approvals. The company plans to scale its manufacturing and initiate commercialization efforts once it receives marketing approval for its products.
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Resources:
- Humacyte, Inc. (HUMA) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Humacyte, Inc. (HUMA)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Humacyte, Inc. (HUMA)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.