$25 million equity investment by Pfizer at $9.90 per share
Hercules term loan facility offering up to $100 million
If fully drawn, Akero Cash Runway is extended for a full year From previously announced Q3 2023 to Q3 2024
SOUTH SAN FRANCISCO, Calif., June 16, 2022 (GLOBE NEWSWIRE) — Akero Therapeutics, Inc. (AKRO), a clinical-stage company developing transformational treatments for patients with serious metabolic diseases marked by unmet medical needs, has today announced two financing transactions. The first is a $25 million equity investment by Pfizer Inc. (:PFE) at $9.90 per share. The second is a term loan facility giving Akero access to up to 0 million from Hercules Capital, Inc. (:HTGC), of which $10 million will be drawn upon closing of the transaction. With existing cash, the proceeds will support Akero’s continued development of efruxifermin (EFX), a long-acting analogue of fibroblast growth factor 21 (FGF21), including two Phase 2b clinical trials in course in patients with pre-cirrhotic and cirrhotic non-alcoholic steatohepatitis (NASH); manufacture of a drug product-device combination for use in phase 3 clinical trials; and the start of a Phase 3 clinical trial program. If the term loan is fully drawn down, proceeds from these two transactions along with budget optimization efforts are expected to fund Akero’s current operating plan until ‘ to Q3 2024. This extends Akero’s previously announced cash forecast by a full year (Q3 2023 to Q3 2024), two years after the expected reading of the HARMONY study in the third quarter of this year.
“Pfizer has deep expertise and experience in addressing health issues that affect millions of patients worldwide, including cardiometabolic diseases. We are honored and delighted to have their trust, collaboration and support,” said Andrew Cheng, MD Ph.D., President and CEO of Akero. “Furthermore, Hercules Capital has a rich history of investing in innovative biotechnology companies. We are very grateful for their important partnership and support. With our existing cash, we expect these two financings to extend our cash trail by two full years beyond our next HARMONY reading, providing us with the flexibility to optimize our capital structure to support EFX’s continued development.
Pfizer is investing in Akero through the Pfizer Breakthrough Growth Initiative (PBGI), which aims to support biotech companies that share its commitment to delivering transformative therapies to patients in therapeutic areas aligned with Pfizer’s core areas of focus. Under the terms of the agreement, Akero has agreed to sell 2,525,252 shares to Pfizer at a price of $9.90 per share, for gross proceeds of $25 million. The common shares were offered and sold to Pfizer pursuant to a registered direct offer conducted without an underwriter or selling agent. The offering is expected to close on or about June 17, 2022. Following the transaction, Pfizer will own approximately 6.7% of the outstanding common shares of Akero. As part of the transaction, Akero will establish a scientific advisory board, with Pfizer appointing one member. Akero will retain ownership and control of EFX, the rest of its pipeline and Akero’s operations.
“EFX has quickly emerged as a promising potential NASH therapy, with a strong record of clinical trial data,” said Jeff Pfefferkorn, Ph.D., vice president of discovery and development, Internal Medicine Research Unit. , Pfizer, who is expected to join Akero’s newly formed Scientific Advisory Board. “NASH is a priority therapeutic area for Pfizer due to the significant global unmet medical need it represents, and we are pleased to support Akero as it advances EFX into a potential Phase 3 study.”
The $100 million term loan facility is provided by Hercules Capital, a leader in customized specialty financing for life science companies. Under the terms of the loan agreement, $10 million will be drawn at closing. An additional $10 million is immediately available to Akero at its sole discretion. Akero may draw an additional $35 million in two separate tranches upon achieving near-term clinical and financial milestones. An additional $45 million can be drawn down in a third tranche, subject to Hercules Capital’s approval. The loan bears an initial interest rate of 7.65% and adjusts according to future changes in the prime rate. Akero will only pay interest for the first 24 months, extendable to 36 months upon reaching certain milestones. The loan matures 54 months from the December 2026 closing. Capital. “We are excited to support Akero – now and in the future – in its continued clinical development of EFX for the treatment of advanced NASH.”
About Akero Therapeutics
Akero Therapeutics is a clinical-stage company developing transformational treatments for patients with severe metabolic diseases marked by significant unmet medical need, including non-alcoholic steatohepatitis (NASH), a disease with no approved therapy. Akero’s lead product candidate, efruxifermin (EFX), is a differentiated Fc-FGF21 fusion protein that has been engineered to mimic the balanced biological activity profile of native FGF21, an endogenous hormone that attenuates cellular stress and regulates metabolism throughout the body. EFX is designed to provide convenient once-weekly subcutaneous dosing. The consistency and magnitude of the observed effects positions EFX as a potentially best-in-class drug, if approved, for the treatment of NASH. EFX is currently being evaluated in two Phase 2b clinical trials: the HARMONY study in patients with pre-cirrhotic NASH (fibrosis F2-F3) and the SYMMETRY study in patients with cirrhotic NASH (fibrosis F4, compensated). Akero is headquartered in South San Francisco. Visit www.akerotx.com for more information.
Statements in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements, including, but not limited to, statements regarding the Company’s cash trail, including its extension to the third quarter of 2024 , statements regarding the completion and timing of the registered offering of the Company’s common stock to Pfizer Inc., the company’s business plans and objectives, including future plans or expectations for EFX, milestones upcoming and therapeutic effects of EFX, as well as EFX dosing, safety and tolerability; the conduct of the Company’s Phase 2b HARMONY study, including the expected timing for reporting results; the conduct of the Company’s Phase 2b SYMMETRY study, including the expected timeline for completing enrollment and reporting results; the timely availability of a new drug substance and a new drug-device combination to support Phase 3 clinical trials; expectations regarding the use of capital, expenses and other future financial results of the Company and the potential impact of COVID-19 on strategy, future operations, manufacturing, clinical trial enrollment and fundraising data. All forward-looking statements contained in this press release are based on management’s current expectations regarding future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those expressed or implied by such forward-looking statements. statements. Risks that contribute to the uncertain nature of forward-looking statements include: risks relating to the impact of COVID-19 on the Company’s current and future business, including potential adverse impacts on Company employees, third parties, manufacturers, supply chain and production as well as global economies and financial markets; the success, cost and timing of the Company’s product candidate development activities and planned clinical trials; the Company’s ability to execute its strategy; positive results from a clinical study are not necessarily predictive of the results of future or ongoing clinical studies; regulatory developments in the United States and foreign countries; the Company’s ability to finance its operations; as well as the risks and uncertainties discussed in more detail under the heading “Risk Factors” in the Company’s most recent quarterly report on Form 10-Q, as filed with the Securities and Exchange Commission (SEC) as well as discussions of potential risks, uncertainties and other important factors in the Company’s other filings and reports with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. The Company undertakes no obligation to update these statements to reflect events that occur or circumstances that exist after the date on which they were made.