Akero Therapeutics, Inc. (AKRO): history, ownership, mission, how it works & makes money

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Akero Therapeutics, Inc. (AKRO) Information


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:

  1. 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.
  2. 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.