Akero Therapeutics, Inc. (AKRO) Bundle
A Brief History of Akero Therapeutics, Inc.
Akero Therapeutics, Inc. was incorporated in January 2017 and has focused on developing treatments for metabolic diseases, particularly non-alcoholic steatohepatitis (NASH). The company’s lead product candidate, EFX, is currently under development and has seen significant investment and interest from the pharmaceutical sector.
Initial Public Offering and Early Funding
Akero went public on June 24, 2019, completing its initial public offering (IPO) by issuing 6,612,500 shares at a price of $16.00 per share, raising approximately $105.8 million in gross proceeds. This capital was primarily used to fund research and development activities, including the advancement of EFX through clinical trials.
Financial Developments and Capital Raising
Throughout its history, Akero has raised substantial capital through various equity offerings. Notable transactions include:
- July 2020: Follow-on public offering of 6,012,390 shares at $36.00 per share, netting approximately $203.5 million.
- September 2022: Raised $230 million through a follow-on public offering.
- February 2024: Raised $10.9 million from sales under an At-The-Market (ATM) offering.
- March 2024: Follow-on public offering raised $366.9 million from the issuance of 12,650,000 shares at $29.00 per share.
Recent Financial Performance
As of September 30, 2024, Akero reported the following financial metrics:
Metric | 2024 (9 months) | 2023 (9 months) |
---|---|---|
Net cash used in operating activities | $(163,017,000) | $(96,740,000) |
Net cash used in investing activities | $(124,980,000) | $(236,409,000) |
Net cash provided by financing activities | $369,855,000 | $352,814,000 |
Net loss | $(182,036,000) | $(96,573,000) |
Research and development expenses | $178,204,000 | $88,406,000 |
General and administrative expenses | $29,194,000 | $22,591,000 |
Stock Performance and Market Position
As of September 30, 2024, Akero had approximately 69.6 million shares outstanding. The company’s stock performance has been volatile, reflecting both the challenges inherent in drug development and the optimism surrounding potential NASH therapies. The company's market capitalization has fluctuated significantly with its funding rounds and clinical trial updates.
Funding and Debt Obligations
As of September 30, 2024, Akero had cash, cash equivalents, and marketable securities totaling $787.1 million. The company has also secured $35 million through a term loan with Hercules Capital, which is subject to specific drawdown conditions and repayment terms.
Future Outlook
Akero is focused on continuing the development of EFX and expects to incur significant operating expenses as it advances through clinical trials. The company’s future funding requirements will depend heavily on the progress of its clinical programs and the successful commercialization of its product candidates.
Funding Source | Amount Raised | Date |
---|---|---|
IPO | $105.8 million | June 2019 |
Follow-on offering | $203.5 million | July 2020 |
Follow-on offering | $230 million | September 2022 |
ATM Offering | $10.9 million | February 2024 |
Follow-on offering | $366.9 million | March 2024 |
A Who Owns Akero Therapeutics, Inc. (AKRO)
Major Shareholders
As of September 30, 2024, the following table summarizes the major shareholders of Akero Therapeutics, Inc. (AKRO):
Shareholder | Number of Shares Owned | Ownership Percentage |
---|---|---|
Amgen, Inc. | 6,858,461 | 9.83% |
Pfizer, Inc. | 2,525,252 | 3.63% |
BlackRock, Inc. | 4,187,000 | 6.01% |
Vanguard Group, Inc. | 3,762,000 | 5.41% |
Other Institutional Investors | 30,000,000 | 43.11% |
Retail Investors | 18,573,000 | 26.39% |
Stock Performance and Market Capitalization
As of March 31, 2024, Akero Therapeutics had approximately 69,148,429 shares outstanding. The stock price was trading at approximately $21.75 per share, leading to a market capitalization of about $1.5 billion.
Recent Financing Activities
In March 2024, Akero completed a follow-on public offering, issuing 12,650,000 shares at a public offering price of $29.00 per share, resulting in net proceeds of approximately $344.8 million .
Financial Overview
For the nine months ended September 30, 2024, Akero reported:
- Net loss of $182.0 million
- Cash and cash equivalents of $787.1 million
- Operating expenses totaling $207.4 million
Insider Ownership
Insider ownership as of September 30, 2024, included:
- Executive Officers, Directors, and their affiliates: 5,000,000 shares
- Total insider ownership: approximately 7.2%
Options and Warrants
As of September 30, 2024, the following options and warrants were outstanding:
- Options outstanding under the 2018 Stock Option and Grant Plan: 679,016
- Options outstanding under the 2019 Stock Option and Incentive Plan: 6,617,378
- Warrants to purchase common stock associated with Loan Agreement: 64,257
Debt Financing
As of September 30, 2024, Akero had outstanding borrowings of $35.0 million under a term loan agreement with Hercules Capital, Inc., with further potential borrowings of up to $30.0 million available until June 15, 2025 .
Future Funding Needs
Akero anticipates requiring substantial additional funding to support its ongoing operations, particularly for the development of EFX and any future product candidates. The company expects to finance these needs through equity sales, debt financing, or other capital sources .
Akero Therapeutics, Inc. (AKRO) Mission Statement
Company Overview
Akero Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing transformative therapies for patients with serious metabolic diseases. The company's lead product candidate is EFX, an investigational treatment for patients with metabolic dysfunction associated with non-alcoholic steatohepatitis (MASH).
Mission Statement
As of 2024, Akero Therapeutics, Inc. aims to advance the understanding and treatment of metabolic diseases with a mission to develop innovative therapies that improve the lives of patients suffering from these conditions. Their commitment is to harness scientific excellence and a patient-centric approach to deliver effective solutions.
Financial Overview
As of September 30, 2024, Akero Therapeutics reported the following financial metrics:
Financial Metric | 2024 (Nine Months Ended) | 2023 (Nine Months Ended) |
---|---|---|
Net Loss | $182.0 million | $96.6 million |
Cash, Cash Equivalents, and Marketable Securities | $787.1 million | $366.9 million |
Total Operating Expenses | $207.4 million | $111.0 million |
Research and Development Expenses | $178.2 million | $88.4 million |
General and Administrative Expenses | $29.2 million | $22.6 million |
Net Cash Used in Operating Activities | $(163.0 million) | $(96.7 million) |
Net Increase in Cash and Cash Equivalents | $81.9 million | $19.7 million |
Funding and Investment
From inception through September 30, 2024, Akero has raised gross proceeds totaling $1,427.9 million from various funding sources, including:
- $105.8 million from the initial public offering in June 2019
- $216.4 million from a follow-on public offering in July 2020
- $230.0 million from a follow-on public offering in September 2022
- $366.9 million from a follow-on public offering in March 2024
- $25.0 million equity investment from Pfizer, Inc. in 2022
- Term loans totaling $35.0 million from Hercules Capital, Inc.
Clinical Development Pipeline
Akero is advancing its lead product candidate, EFX, through clinical trials. The company expects to incur significant expenses as it proceeds through later-stage clinical development. The following table summarizes key clinical milestones:
Milestone | Expected Date | Status |
---|---|---|
Phase 3 SYNCHRONY Histology Study Completion | Mid-2026 | Ongoing |
Phase 3 SYNCHRONY Real World Study Completion | Late 2026 | Ongoing |
Market Position and Strategy
Akero Therapeutics is positioned to capitalize on the growing demand for effective treatments for metabolic diseases. The company’s strategy focuses on:
- Innovating through scientific research and development
- Expanding its product pipeline
- Building strategic partnerships to enhance market reach
Conclusion
Akero Therapeutics, Inc. continues to focus on its mission to develop impactful therapies for metabolic diseases while navigating through significant financial and operational challenges.
How Akero Therapeutics, Inc. (AKRO) Works
Company Overview
Akero Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing treatments for serious metabolic diseases, particularly metabolic dysfunction-associated steatohepatitis (MASH). The lead product candidate, efruxifermin (EFX), is in advanced clinical trials aimed at addressing significant unmet medical needs in this area.
Financial Performance
As of September 30, 2024, Akero reported significant financial data reflecting its ongoing research and development activities:
Financial Metrics | Q3 2024 (in thousands) | Q3 2023 (in thousands) |
---|---|---|
Net Cash Used in Operating Activities | $(163,017) | $(96,740) |
Net Cash Used in Investing Activities | $(124,980) | $(236,409) |
Net Cash Provided by Financing Activities | $369,855 | $352,814 |
Net Increase in Cash, Cash Equivalents and Restricted Cash | $81,858 | $19,665 |
Net Loss | $(182,036) | $(96,573) |
Cash, Cash Equivalents, and Marketable Securities | $787,100 | Not Applicable |
Research and Development Expenses
Research and development (R&D) expenses for the nine months ended September 30, 2024, were as follows:
Expense Category | Q3 2024 (in thousands) | Q3 2023 (in thousands) |
---|---|---|
Direct EFX Program Expenses | $157,302 | $72,931 |
Personnel and Other R&D Related Expenses | $20,902 | $15,475 |
Total R&D Expenses | $178,204 | $88,406 |
Operating Expenses
Operating expenses were reported as follows for the nine months ended September 30, 2024:
Expense Type | Q3 2024 (in thousands) | Q3 2023 (in thousands) |
---|---|---|
General and Administrative Expenses | $29,194 | $22,591 |
Total Operating Expenses | $207,398 | $110,997 |
Capital Structure and Funding
Akero has raised substantial capital through various financing activities:
- Gross proceeds of $366.9 million from a follow-on public offering in March 2024.
- Gross proceeds of $10.9 million from sales of common stock under an ATM offering in February 2024.
- Borrowed $10.0 million from Hercules Capital in February 2024.
- Raised $220.0 million from an underwritten registered direct offering in May 2023.
- Raised $127.4 million under an ATM offering in April and May 2023.
Debt Obligations
Akero has outstanding borrowings of $35.0 million under a loan agreement with Hercules, with the potential to draw an additional $30.0 million until June 15, 2025. The loan is subject to an interest rate of 7.65% or the Prime Rate plus 3.65%, whichever is greater.
Marketable Securities
As of September 30, 2024, the company held the following marketable securities:
Type of Securities | Amortized Cost (in thousands) | Fair Value (in thousands) |
---|---|---|
Money Market Funds | $303,324 | $303,324 |
U.S. Treasury Securities | $246,981 | $248,440 |
U.S. Government Agency Securities | $70,042 | $70,258 |
Commercial Paper | $58,954 | $59,078 |
Corporate Debt Securities | $92,926 | $93,230 |
Stock Performance
As of September 30, 2024, Akero had 69,614,587 shares of common stock outstanding, with a net loss per share of $2.76 for the nine months ended September 30, 2024.
Clinical Development Pipeline
The company is advancing EFX through the SYNCHRONY clinical program, which includes:
- Three ongoing clinical trials: Outcomes, Histology, and Real-World.
- Focus on patients with pre-cirrhotic MASH (F2-F3) and compensated cirrhosis (F4).
- Building on two previous Phase 2b studies involving over 300 patients treated for up to 96 weeks.
Conclusion on Financial Viability
Akero is expected to continue incurring significant operational expenses and net losses as it progresses through clinical trials and seeks regulatory approval for EFX. As of September 30, 2024, the company believes its cash reserves will fund operations through the second half of 2027, but additional funding will be necessary for future growth and development.
How Akero Therapeutics, Inc. (AKRO) Makes Money
Revenue Model
As of September 30, 2024, Akero Therapeutics has not generated any revenue since its inception and does not expect to generate revenue from product sales in the near future. The company relies on financing through equity offerings and collaborations to fund its operations.
Funding Sources
From its inception through September 30, 2024, Akero has raised gross proceeds totaling $1,427.9 million, primarily through:
- Initial Public Offering (IPO) in June 2019: $105.8 million
- Follow-on Public Offering in July 2020: $216.4 million
- Equity Investment from Pfizer in June 2022: $25.0 million
- Follow-on Public Offering in September 2022: $230.0 million
- Follow-on Public Offering in March 2024: $366.9 million
- At-The-Market (ATM) Offering: $127.4 million in April and May 2023 and $10.9 million in February 2024
- Term Loans from Hercules Capital: $35.0 million
Financial Performance
For the nine months ended September 30, 2024, Akero reported:
- Net Loss: $182.0 million
- Net Cash Used in Operating Activities: $163.0 million
- Net Cash Used in Investing Activities: $125.0 million
- Net Cash Provided by Financing Activities: $369.9 million
Cash Flow Summary
Period | Net Cash Used in Operating Activities (in thousands) | Net Cash Used in Investing Activities (in thousands) | Net Cash Provided by Financing Activities (in thousands) | Net Increase in Cash and Cash Equivalents (in thousands) |
---|---|---|---|---|
Nine Months Ended September 30, 2024 | ($163,017) | ($124,980) | $369,855 | $81,858 |
Nine Months Ended September 30, 2023 | ($96,740) | ($236,409) | $352,814 | $19,665 |
Operating Expenses
For the nine months ended September 30, 2024, Akero's operating expenses were:
- Research and Development: $178.2 million
- General and Administrative: $29.2 million
- Total Operating Expenses: $207.4 million
Research and Development Expenses Breakdown
Category | 2024 (in thousands) | 2023 (in thousands) | $ Change (in thousands) | % Change |
---|---|---|---|---|
Direct EFX Program Expenses | $157,302 | $72,931 | $84,371 | 116% |
Personnel and Other R&D Related Expenses | $20,902 | $15,475 | $5,427 | 35% |
Total R&D Expenses | $178,204 | $88,406 | $89,798 | 102% |
Cash and Securities Position
As of September 30, 2024, Akero had:
- Cash, Cash Equivalents, and Short- and Long-term Marketable Securities: $787.1 million
Debt Obligations
Akero has a term loan agreement with Hercules Capital totaling $35.0 million, with potential additional borrowings of up to $30.0 million available until June 2025 and $35.0 million until June 2026. The loan has an interest rate of at least 7.65% or the Prime Rate plus 3.65%.
Future Funding Requirements
Akero anticipates significant ongoing expenses for research and development and will require additional capital to support its operations and growth strategy.
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Resources:
- Akero Therapeutics, Inc. (AKRO) Financial Statements – Access the full quarterly financial statements for Q3 2024 to get an in-depth view of Akero Therapeutics, Inc. (AKRO)' financial performance, including balance sheets, income statements, and cash flow statements.
- SEC Filings – View Akero Therapeutics, Inc. (AKRO)' latest filings with the U.S. Securities and Exchange Commission (SEC) for regulatory reports, annual and quarterly filings, and other essential disclosures.