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 and full year ended December 31, 2019.
"The fourth quarter of 2019 capped an exciting
year for 89bio where we reported positive topline data from our
single ascending dose study of BIO89-100, scaled up our operations
and manufacturing, and successfully completed an upsized initial
public offering," said Rohan Palekar, Chief Executive Officer
of 89bio. "We expect 2020 to be another transformative year with
topline data from our Phase 1b/2a nonalcoholic steatohepatitis
(NASH) study expected in the second half of 2020 and planned
initiation of our Phase 2 study in severe hypertriglyceridemia
(SHTG) in the first half of 2020.”
Recent Highlights and Upcoming
Milestones
Phase 1b/2a Trial of BIO89-100 in
NASH. In September 2019, 89bio announced that it had
initiated dosing in its proof of concept Phase 1b/2a clinical
trial evaluating BIO89-100 in patients with NASH or patients with
nonalcoholic fatty liver disease (NAFLD) and a high risk of
NASH. Enrollment in the study has been progressing well with
topline data expected in the second half of 2020.
Phase 2 Trial of BIO89-100 in
SHTG. 89bio’s Phase 2 clinical trial evaluating BIO89-100
in patients with SHTG, which has a planned primary endpoint of
reduction from baseline in triglycerides, is currently on track for
initiation in the first half of 2020 and topline data in the first
half of 2021.
Completed Successful Upsized Initial
Public Offering. 89bio completed a successful, upsized IPO
on November 13, 2019 that priced at $16.00 per share. The gross
proceeds of the offering were approximately $97.6 million,
which included the exercise in full by the underwriters of their
option to purchase additional shares of common stock. The gross
proceeds were calculated before deducting underwriting discounts
and commissions and other offering expenses payable by 89bio.
Fourth Quarter and Full Year 2019
Financial Results
Cash Position. As of December
31, 2019, 89bio had cash and cash equivalents of $93.4
million, including the net proceeds from our IPO.
Research and Development (R&D)
Expenses. R&D expenses were $7.2
million and $21.4 million for the three months and year ended
December 31, 2019, respectively, compared to $3.7
million and $13.7 million for the three months and year ended
December 31, 2018, respectively. The increase for the year ended
December 31, 2019 was primarily driven by increases in clinical
development, contract manufacturing, pre-clinical, and personnel
expenses.
General and Administrative (G&A)
Expenses. G&A expenses were $2.4 million and $5.3
million for the three months and year ended December 31,
2019, respectively, compared to $0.7 million and $1.5
million for the three months and year ended December 31,
2018, respectively. The increase for the year ended December 31,
2019 was primarily due to costs incurred in preparation to be a
public company and personnel related costs.
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 enrollment, completion and outcome of 89bio’s proof
of concept Phase 1b/2a 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;
liquidity and capital resources; and other risks and uncertainties
identified in 89bio’s Quarterly Report on Form 10-Q for the quarter
ended September 30, 2019, filed December 18, 2019 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.
|
89bio, Inc.
Condensed Consolidated Statement of Operations and
Comprehensive Loss (Unaudited) (In thousands, except share
and per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Period
from |
|
|
Three
months |
|
Three
months |
|
Year |
|
January
18, |
|
|
Ended |
|
Ended |
|
Ended |
|
2018
(inception) |
|
|
December 31, |
|
December 31, |
|
December 31, |
|
to December 31, |
|
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
7,192 |
|
$ |
3,692 |
|
$ |
21,346 |
|
$ |
13,681 |
General and administrative |
|
|
2,419 |
|
|
716 |
|
|
5,294 |
|
|
1,481 |
Total operating expenses |
|
|
9,611 |
|
|
4,408 |
|
|
26,640 |
|
|
15,162 |
Loss from
operations |
|
|
9,611 |
|
|
4,408 |
|
|
26,640 |
|
|
15,162 |
Other
(income) expenses, net |
|
|
9,540 |
|
|
202 |
|
|
30,562 |
|
|
986 |
Net loss
before tax |
|
|
19,151 |
|
|
4,610 |
|
|
57,202 |
|
|
16,148 |
Income tax
expense |
|
|
132 |
|
|
28 |
|
|
218 |
|
|
28 |
Net loss and
comprehensive loss |
|
$ |
19,283 |
|
$ |
4,638 |
|
$ |
57,420 |
|
$ |
16,176 |
Net loss per
share, basic and diluted |
|
$ |
2.58 |
|
$ |
7.59 |
|
$ |
24.49 |
|
$ |
36.45 |
Weighted-average shares used to compute net loss per share, basic
and diluted |
|
|
7,486,577 |
|
|
611,226 |
|
|
2,344,191 |
|
|
443,767 |
|
|
|
|
|
|
|
|
|
|
89bio, Inc.
Condensed Consolidated Balance Sheet Data (Unaudited) (In
thousands) |
|
|
|
|
|
December
31, |
|
December
31, |
|
|
2019 |
|
2018 |
|
|
|
|
|
Cash and cash equivalents |
$ |
93,360 |
|
$ |
11,257 |
|
Total
Assets |
|
95,553 |
|
|
11,369 |
|
Total
current liabilities |
|
5,609 |
|
|
4,353 |
|
Convertible
preferred stock/shares |
|
— |
|
|
23,073 |
|
Total
stockholders’ equity (deficit) |
|
89,944 |
|
|
(16,057 |
) |
|
|
|
|
Investor Contact: Ryan Martins Chief Financial
Officerinvestors@89bio.com
Media Contact: Lori Rosen LDR Communications
917-553-6808lori@ldrcommunications.com
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