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 June 30, 2020.
“We are pleased with the progress we have made
with our Phase 1b/2a trial for nonalcoholic steatohepatitis (NASH)
and look forward to reporting topline results in late third quarter
to early fourth quarter of this year,” said Rohan Palekar,
Chief Executive Officer of 89bio. “With our strengthened capital
position, we look forward to continuing to advance BIO89-100 and
remain on track to initiate the Phase 2 trial in severe
hypertriglyceridemia (SHTG) patients during this
quarter.”
Recent Highlights and Upcoming
Milestones
Topline results from the Phase 1b/2a
trial of BIO89-100 in NASH are expected in Late Q3 to Early
Q4. In April 2020, 89bio closed enrollment in its Phase
1b/2a trial of BIO89-100 in NASH. Topline results are expected in
late Q3 to early Q4.
Phase 2 trial of BIO89-100 in SHTG on
track for initiation in Q3. On May 8, 2020, the Division
of Diabetes, Lipid Disorders, and Obesity at the U.S. Food and Drug
Administration (FDA) cleared the Investigational New Drug (IND)
application for BIO89-100 in patients with
SHTG.
Completed underwritten offering of
common stock. In July 2020, 89bio received approximately
$78.3 million in net proceeds from an underwritten offering of
common stock.
Second Quarter 2020 Financial
Results
Cash Position. As of June 30,
2020, 89bio had cash, cash equivalents, and short-term investments
of $73.9 million.
Research and Development (R&D)
Expenses. R&D expenses were $8.4 million for
the three months ended June 30, 2020, compared to $3.2 million
for the three months ended June 30, 2019. The increase in R&D
expenses was primarily driven by increases in clinical development,
contract manufacturing, pre-clinical development and personnel
expenses.
General and Administrative (G&A)
Expenses. G&A expenses were $3.2 million for the
three months ended June 30, 2020, compared to $0.8 million for
the three months ended June 30, 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 $11.8 million for the three months ended June 30, 2020,
compared to a net loss of $15.0 million for the three months
ended June 30, 2019. The decrease in net loss is primarily
attributable to increased R&D expenses for our programs and
increased G&A expenses associated with our becoming a public
company offset by a non-recurring charge in 2019 for accounting of
preferred stock liability.
About BIO89-100BIO89-100 is a
glycoPEGylated analog of FGF21 being developed for the treatment of
NASH and 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 and a Phase 2 trial in patients with
SHTG is expected to initiate shortly. 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 and 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 and a Phase 2
trial in patients with SHTG is expected to initiate shortly. 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-Q for the quarter ended March 31, 2020, filed May 13, 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.
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89bio, Inc. Condensed Consolidated Statement of Operations
Data (Unaudited) (In thousands, except share and per share
amounts) |
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|
|
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Three Months Ended |
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Six Months Ended |
|
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June 30, |
|
June 30, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
|
|
|
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Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
8,443 |
|
|
$ |
3,165 |
|
|
$ |
16,221 |
|
|
$ |
7,474 |
|
General and administrative |
|
|
3,230 |
|
|
|
834 |
|
|
|
6,154 |
|
|
|
1,357 |
|
Total operating expenses |
|
|
11,673 |
|
|
|
3,999 |
|
|
|
22,375 |
|
|
|
8,831 |
|
Loss from operations |
|
|
11,673 |
|
|
|
3,999 |
|
|
|
22,375 |
|
|
|
8,831 |
|
Other expenses (income), net |
|
|
98 |
|
|
|
10,968 |
|
|
|
(59 |
) |
|
|
10,552 |
|
Net loss before tax |
|
|
11,771 |
|
|
|
14,967 |
|
|
|
22,316 |
|
|
|
19,383 |
|
Income tax expense (benefit) |
|
|
— |
|
|
|
6 |
|
|
|
(1 |
) |
|
|
29 |
|
Net loss and comprehensive loss |
|
$ |
11,771 |
|
|
$ |
14,973 |
|
|
$ |
22,315 |
|
|
$ |
19,412 |
|
Net loss per share, basic and diluted |
|
$ |
0.85 |
|
|
$ |
24.50 |
|
|
$ |
1.62 |
|
|
$ |
31.76 |
|
Weighted-average shares used to compute net loss per share, basic
and diluted |
|
|
13,797,356 |
|
|
|
611,226 |
|
|
|
13,793,544 |
|
|
|
611,226 |
|
|
|
|
|
|
|
|
|
|
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89bio, Inc. Condensed Consolidated Balance Sheet Data
(Unaudited) (In thousands) |
|
|
|
|
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June 30, |
|
December 31, |
|
|
2020 |
|
|
|
2019 |
|
|
|
|
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Cash, cash equivalents and short-term investments |
$ |
73,896 |
|
|
$ |
93,335 |
|
Total Assets |
|
76,562 |
|
|
|
95,553 |
|
Total current liabilities |
|
6,791 |
|
|
|
5,609 |
|
Total stockholders’ equity |
|
69,771 |
|
|
|
89,944 |
|
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Investor Contact: Ryan Martins Chief Financial Officer
investors@89bio.com
Media Contact: Lori Rosen LDR Communications 917-553-6808
lori@ldrcommunications.com
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