Akero Therapeutics Announces Two Financing Transactions with Pfizer Inc. and Hercules Capital, Inc. Providing Access to Up To $125 Million
16 Juni 2022 - 1:00PM
Akero Therapeutics, Inc. (Nasdaq: AKRO), a clinical-stage
company developing transformational treatments for patients with
serious metabolic diseases marked by high unmet medical need, today
announced two financing transactions. The first is a $25 million
equity investment by Pfizer Inc. (NYSE: PFE) at $9.90 per share.
The second is a term loan facility providing Akero with access to
up to $100 million from Hercules Capital, Inc. (NYSE: HTGC), of
which $10 million will be drawn at transaction close. Together with
existing cash, proceeds will support Akero’s continued development
of efruxifermin (EFX), a long-acting analog of fibroblast growth
factor 21 (FGF21), including two ongoing Phase 2b clinical trials
in patients with pre-cirrhotic and cirrhotic nonalcoholic
steatohepatitis (NASH); manufacture of a drug product-device
combination for use in Phase 3 clinical trials; and starting a
Phase 3 clinical trial program. If the term loan is fully drawn,
proceeds from these two transactions together with budget
optimization efforts are expected to fund Akero’s current operating
plan until the third quarter of 2024. This extends Akero’s
previously announced cash guidance by a full year (from the third
quarter of 2023 to the third quarter of 2024), two years beyond the
anticipated readout of the HARMONY study in the third quarter of
this year.
“Pfizer has deep expertise and history in addressing health
challenges that affect millions of patients around the world,
including cardiometabolic diseases. We are honored and excited to
have their confidence, collaboration and support,” said Andrew
Cheng, M.D. Ph.D., president and chief executive officer of Akero.
“In addition, Hercules Capital has a rich history of investing in
innovative biotechnology companies. We are very grateful for their
significant partnership and support. With our existing cash on
hand, we expect these two financings will extend our cash runway a
full two years beyond our upcoming HARMONY readout, providing us
the flexibility to optimize our capital structure to support the
continued development of EFX.”
Pfizer is investing in Akero through the Pfizer Breakthrough
Growth Initiative (PBGI), which seeks to support biotechnology
companies that share its commitment to delivering transformative
therapies for patients in therapeutic areas consistent 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 shares of
common stock were offered and sold to Pfizer in a registered direct
offering conducted without an underwriter or placement agent. The
offering is expected to close on or about June 17, 2022. Following
the transaction, Pfizer will own approximately 6.7% of Akero’s
outstanding common stock. As part of the transaction, Akero will
establish a Scientific Advisory Board, with Pfizer appointing one
member. Akero will maintain 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 & 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 substantial global unmet
medical need it represents, and we are excited to support Akero as
it advances EFX towards a potential Phase 3 study.”
The $100 million term loan facility is being 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
achievement of near-term clinical and financial milestones. An
additional $45 million may be drawn in a third tranche, subject to
the approval of Hercules Capital. The loan bears an initial
interest rate of 7.65% and adjusts with future changes in the prime
rate. Akero will pay interest only for the first 24 months,
extendable to 36 months on achievement of certain milestones. The
loan matures 54 months from closing in December 2026. “We believe
there is tremendous patient and clinical value in financing the
development of potentially innovative treatments for NASH,” said
Cristy Barnes, Managing Director at Hercules Capital. “We’re
excited to support Akero – both 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 serious metabolic diseases marked by high unmet
medical need, including non-alcoholic steatohepatitis (NASH), a
disease without any approved therapies. 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
alleviates cellular stress and regulates metabolism throughout the
body. EFX is designed to offer convenient once-weekly subcutaneous
dosing. The consistency and magnitude of observed effects position
EFX to be a potentially best-in-class medicine, if approved, for
treatment of NASH. EFX is currently being evaluated in two Phase 2b
clinical trials: the HARMONY study in patients with pre-cirrhotic
NASH (F2-F3 fibrosis), and the SYMMETRY study in patients with
cirrhotic NASH (F4 fibrosis, compensated). Akero is headquartered
in South San Francisco. Visit www.akerotx.com for more
information.
Forward-Looking Statements Statements contained
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 runway, including its
extension to the third quarter of 2024, statements about 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,
upcoming milestones, and therapeutic effects of EFX, as well as the
dosing, safety and tolerability of EFX; conduct of the Company’s
Phase 2b HARMONY study, including expected timing to report
results; conduct of the Company’s Phase 2b SYMMETRY study,
including expected timing to complete enrollment and report
results; the timely availability of new drug substance and a new
combination drug product-device to support Phase 3 clinical trials;
expectations regarding the Company’s use of capital, expenses and
other future financial results and the potential impact of COVID-19
on strategy, future operations, manufacturing, and clinical trial
enrollment and data collection. Any forward-looking statements in
this press release are based on management's current expectations
of future events and are subject to a number of risks and
uncertainties that could cause actual results to differ materially
and adversely from those set forth in or implied by such
forward-looking statements. Risks that contribute to the uncertain
nature of the forward-looking statements include: risks related to
the impact of COVID-19 on the Company's ongoing and future
operations, including potential negative impacts on the Company’s
employees, third-parties, manufacturers, supply chain and
production as well as on 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 on its strategy; positive results from a
clinical study may not necessarily be predictive of the results of
future or ongoing clinical studies; regulatory developments in the
United States and foreign countries; the Company's ability to fund
operations; as well as those risks and uncertainties set forth more
fully under the caption "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 such statements to reflect events that occur or
circumstances that exist after the date on which they were
made.
Investor Contact:Christina
Tartaglia212.362.1200IR@akerotx.com
Media Contact:650.487.6488media@akerotx.com
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