89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical
company focused on the development and commercialization of
innovative therapies for the treatment of liver and
cardio-metabolic diseases, today reported its financial results for
the quarter ended March 31, 2020.
“We are excited to have closed enrollment in our
Phase 1b/2a trial for nonalcoholic steatohepatitis (NASH) and look
forward to reporting topline results in the second half of 2020,”
said Rohan Palekar, Chief Executive Officer of 89bio. “The
recent clearance by the FDA of our Investigational New Drug (IND)
application for severe hypertriglyceridemia (SHTG) puts us in
position to initiate our Phase 2 trial of BIO89-100 for the
treatment of SHTG when conditions permit safe and effective
execution of the trial.”
Recent Highlights and Upcoming
Milestones
Closed enrollment in the Phase 1b/2a
trial of BIO89-100 in NASH. In April 2020, 89bio closed
enrollment in its Phase 1b/2a
trial of BIO89-100 in NASH with 98% of patients enrolled.
89bio is working closely with its contract research organization
partners and clinical sites to mitigate, where possible, any
potential impact of the COVID-19 pandemic on the trial. In this
trial, 81 patients were randomized to receive weekly or every other
week subcutaneous dosing of BIO89-100 or placebo for 12 weeks.
Topline results are expected in the second half of 2020.
FDA Clearance of BIO89-100’s IND
application for SHTG. On May 8, 2020, the Division of
Diabetes, Lipid Disorders, and Obesity at the FDA cleared the IND
Application for BIO89-100 in patients with SHTG. In April 2020,
89bio announced that it was delaying initiation of its Phase 2
trial of BIO89-100 for the treatment of SHTG due to the COVID-19
pandemic. 89bio is planning to complete all activities in order to
be operationally prepared to enroll the trial once the external
environment is conducive to executing the trial safely and
effectively.
New preclinical data confirms
BIO89-100’s mechanism of action via potent FGF receptor
agonism. In April 2020, 89bio released new preclinical
data demonstrating that BIO89-100 had similar activity to
recombinant human FGF21 at very low nanomolar concentrations in
cells co-expressing β-klotho and each of FGF receptors 1c, 2c or
3c. The data suggests that BIO89-100 could reproduce the beneficial
metabolic benefits of the native hormone and confirming its
potential to translate into clinical benefits for patients with
NASH and SHTG. An EC50 could not be calculated for rhFGF21 or
BIO89-100 at FGF receptor R4.
First Quarter 2020 Financial
Results
Cash Position. As of March 31,
2020, 89bio had cash and cash equivalents of $85.5
million.
Research and Development (R&D)
Expenses. R&D expenses were $7.8 million for
the three months ended March 31, 2020, compared to $4.3
million for the three months ended March 31, 2019. The increase in
R&D expenses was primarily driven by increases in clinical
development, pre-clinical development and personnel expenses.
General and Administrative (G&A)
Expenses. G&A expenses were $2.9 million for the
three months ended March 31, 2020, compared to $0.5 million
for the three months ended March 31, 2019. The increase in G&A
expenses was primarily due to an increase in costs related to
professional services and personnel expenses.
Net Loss. 89bio reported a net
loss of $10.5 million for the three months ended March 31, 2020,
compared to a net loss of $4.4 million for the three months
ended March 31, 2019. The increase in net loss is primarily
attributable to increased Research and Development expenses for our
programs and increased General and Administrative expenses
associated with our becoming a public company.
About BIO89-100BIO89-100 is a
glycoPEGylated analog of FGF21 being developed for the treatment of
NASH and a trial is planned for evaluating its role in the
treatment of severe hypertriglyceridemia (SHTG). 89bio has
specifically engineered BIO89-100 using a proprietary
glycoPEGylation technology designed to prolong the biological
activity of native FGF21. In preclinical studies, BIO89-100
demonstrated consistent beneficial effects across a range of
endpoints, including hepatic steatosis, injury, and fibrosis. In
89bio’s Phase 1a clinical trial in healthy volunteers, BIO89-100
demonstrated a favorable tolerability profile and dose-proportional
pharmacokinetics. BIO89-100 also demonstrated statistically
significant improvements in key lipid parameters for two weeks
after a single dose, which combined with results from the company’s
animal studies supports the potential for weekly or once every two
weeks dosing. A proof of concept Phase 1a/2b clinical trial
evaluating BIO89-100 in patients with NASH or NAFLD and a high risk
of NASH is currently underway. About 89bio89bio is
a clinical-stage biopharmaceutical company focused on the
development and commercialization of innovative therapies for the
treatment of liver and cardio-metabolic diseases. The company’s
lead product candidate, BIO89-100, is being developed for the
treatment of NASH. The company also intends to develop BIO89-100
for the treatment of SHTG. BIO89-100 is a specifically engineered
glycoPEGylated analog of FGF21 that is currently in a proof of
concept Phase 1b/2a clinical trial in patients with NASH or NAFLD
and a high risk of NASH. 89bio is headquartered in San Francisco
with operations in Herzliya, Israel. Visit 89bio.com for more
information.
Forward-Looking
StatementsCertain statements in this press release may
constitute “forward-looking statements” within the meaning of the
federal securities laws, including, but not limited to, 89bio’s
expectations regarding plans for its clinical programs and clinical
studies. Words such as “may,” “might,” “will,” “objective,”
“intend,” “should,” “could,” “can,” “would,” “expect,” “believe,”
“design,” “estimate,” “predict,” “potential,” “develop,” “plan” or
the negative of these terms, and similar expressions, or statements
regarding intent, belief, or current expectations, are forward
looking statements. While 89bio believes these forward-looking
statements are reasonable, undue reliance should not be placed on
any such forward-looking statements, which are based on information
available to us on the date of this release. These forward-looking
statements are based upon current estimates and assumptions and are
subject to various risks and uncertainties (including, without
limitation, those set forth in 89bio’s filings with the U.S.
Securities and Exchange Commission (SEC)), many of which are beyond
89bio’s control and subject to change. Actual results could be
materially different. Risks and uncertainties include: expectations
regarding the timing, completion and outcome of 89bio’s Phase
1b/2a proof of concept clinical trial evaluating BIO89-100 in
patients with NASH or patients with NAFLD and a high risk of NASH;
expectations regarding the timing, completion and outcome of
89bio’s proof of concept Phase 2 clinical trial evaluating
BIO89-100 in patients with SHTG; the unpredictable relationship
between preclinical study results and clinical study results; the
effect of the COVID-19 pandemic on 89bio’s clinical trials and
business operations; liquidity and capital resources; and other
risks and uncertainties identified in 89bio’s Annual Report on
Form 10-K for the year ended December 31, 2019, filed March 18,
2020 with the SEC and other subsequent disclosure documents filed
with the SEC. 89bio claims the protection of the Safe Harbor
contained in the Private Securities Litigation Reform Act of 1995
for forward-looking statements. 89bio expressly disclaims any
obligation to update or alter any statements whether as a result of
new information, future events or otherwise, except as required by
law.
Investor Contact: Ryan Martins Chief Financial Officer
investors@89bio.com
Media Contact: Lori Rosen LDR Communications 917-553-6808
lori@ldrcommunications.com
|
89bio, Inc.
Condensed Consolidated Statement of Operations Data (Unaudited) (In
thousands, except share and per share amounts) |
|
|
|
|
|
|
|
Three
months |
|
Three
months |
|
|
Ended |
|
Ended |
|
|
March 31, |
|
March 31, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
Research and development |
|
$ |
7,778 |
|
|
$ |
4,309 |
|
General and administrative |
|
|
2,924 |
|
|
|
523 |
|
Total operating expenses |
|
|
10,702 |
|
|
|
4,832 |
|
Loss from
operations |
|
|
10,702 |
|
|
|
4,832 |
|
Other
income, net |
|
|
(157 |
) |
|
|
(416 |
) |
Net loss
before tax |
|
|
10,545 |
|
|
|
4,416 |
|
Income tax
(benefit) expense |
|
|
(1 |
) |
|
|
23 |
|
Net loss and
comprehensive loss |
|
$ |
10,544 |
|
|
$ |
4,439 |
|
Net loss per
share, basic and diluted |
|
$ |
0.76 |
|
|
$ |
7.26 |
|
Weighted-average shares used to compute net loss per share, basic
and diluted |
|
|
13,789,786 |
|
|
|
611,226 |
|
|
|
|
|
|
|
89bio, Inc.
Condensed Consolidated Balance Sheet Data (Unaudited) (In
thousands) |
|
|
|
|
|
March
31, |
|
December
31, |
|
2020 |
|
2019 |
|
|
|
|
Cash and cash equivalents |
$ |
85,532 |
|
$ |
93,335 |
Total
assets |
|
87,689 |
|
|
95,553 |
Total
current liabilities |
|
7,787 |
|
|
5,609 |
Total
stockholders’ equity |
|
79,902 |
|
|
89,944 |
|
|
|
|
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