89bio Reports Third Quarter 2020 Financial Results and Provides Corporate Update
November 10 2020 - 4:02PM
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 September 30, 2020.
“We have made significant advances across our
development programs this quarter. We initiated our Phase 2 trial
in SHTG and in NASH we announced impressive results from our Phase
1b/2a trial that further support our view that BIO89-100 could be
the best-in-class FGF21 analog within a class that could be the
mainstay of treatment for NASH,” said Rohan Palekar, chief
executive officer of 89bio. “BIO89-100 delivers a compelling
risk-benefit profile by improving liver pathology and addressing
the underlying metabolic issues while balancing these benefits with
favorable tolerability and the dosing convenience necessary for
adoption and compliance. We are moving forward with a comprehensive
clinical development program for BIO89-100, including initiating
the Phase 2b trial in the first half of 2021 and initiating in
parallel a new histology cohort in the near term as part of the
Phase 1b/2a trial. The data from this new cohort will provide
additional supporting information on the efficacy of BIO89-100 and
is not expected to affect our planned timing for initiation of the
Phase 2b/3 program.”
Recent Highlights
-
Reported positive Phase 1b/2a clinical data evaluating BIO89-100 in
NASH. Results observed add to a growing body of evidence
demonstrating the promise of BIO89-100 for the treatment of NASH.
Results showed a strong efficacy and favorable tolerability profile
with weekly and every two-week dosing. Specifically, the data
demonstrated
- Statistically
significant reductions in liver fat of up to 70% versus placebo
with 43% of patients at the highest dose achieving normal liver fat
content of <5%.
- Up to 88% and 71% of
BIO89-100 patients achieved ≥30% and ≥50% liver fat reduction
respectively.
- Significant benefit
in markers of liver injury and fibrosis, with up to 44% reduction
in alanine aminotransferase (ALT) and up to 27% reduction in
Pro-C3. A 35 U/L decrease in patients with high ALT was
observed.
- Significant
improvements in key lipid markers—triglycerides, non-HDL, and LDL.
Reductions in TGs was more pronounced in patients who had higher
levels of TGs at baseline.
- Improvements in the
spectrum of metabolic marker data including HOMA-IR, glucose,
HbA1c, weight and adiponectin.
- Overall, BIO89-100
demonstrated a favorable safety and tolerability profile.
-
Well tolerated across tested dose range with few adverse events
that occurred in ≥ 10% of subjects.
-
Very low frequency of gastrointestinal (GI) events was observed
with a similar profile to placebo.
-
No hypersensitivity or tremor were observed and no adverse effects
on heart rate or blood pressure were observed.
-
Initiated a Phase 2 trial of BIO89-100 in patients with SHTG.
-
Completed underwritten public offerings of common stock in the
third quarter, resulting in an aggregate of approximately $157.7
million in estimated net proceeds.
Expected Upcoming Milestones
-
Present updated clinical data from the Phase 1b/2a trial as a
late-breaking poster at AASLD’s The Liver Meeting® 2020 being held
November 13-16 highlighting BIO89-100’s compelling clinical profile
and preclinical data covering BIO89-100’s receptor activation
profile.
-
Initiate a new open-label histology cohort as part of the Phase
1b/2a trial of BIO89-100 in NASH. This new cohort will enroll
approximately 20 patients with biopsy-confirmed NASH that will be
treated for 20 weeks with 27mg QW BIO89-100.
-
The new cohort will provide an early opportunity to demonstrate
BIO89-100’s benefits on histology endpoints.
-
This cohort is planned to start in the near term with results
expected by the end of 2021.
-
Initiate a Phase 2b NASH trial as part of the Phase 2b/3 program in
the first half of 2021.
-
Report topline data from the Phase 2 trial of BIO89-100 in SHTG in
the second half of 2021.
Third Quarter 2020
Financial Results
Cash Position. As of September
30, 2020, 89bio had cash, cash equivalents and short-term
investments of $219.2 million.
Research and Development (R&D)
Expenses. R&D expenses were $11.2 million
for the three months ended September 30, 2020, compared
to $6.7 million for the three months ended September 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 September 30, 2020, compared to $1.5
million for the three months ended September 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 $14.6 million for the three months ended September 30,
2020, compared to a net loss of $18.7 million for the three
months ended September 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 the Phase 1b/2a Study
89bio’s Phase 1b/2a trial with BIO89-100 in
patients with NASH was a multicenter, randomized, double-blind,
placebo-controlled, multiple ascending dose-ranging trial. It was
designed to assess the safety, tolerability, and PK properties of
BIO89-100 as well as change in liver fat measured by MRI-PDFF and
key biomarker assessments in subjects with biopsy-proven NASH with
fibrosis or subjects with phenotypical NASH (PNASH). PNASH was
defined as patients with steatosis greater than 10% who have
central obesity and Type 2 diabetes or central obesity and evidence
of liver injury. Both populations that were enrolled had similar
disease characteristics at baseline. A total of 81 subjects were
randomized to receive weekly or every two weeks subcutaneous dosing
of BIO89-100 or placebo for up to 12 weeks. Results showed robust
reductions in liver fat and key liver and metabolic markers with a
favorable tolerability profile. The positive results were observed
with weekly and every two-week dosing.
About BIO89-100
BIO89-100 is a glycoPEGylated analog of FGF21
being developed for the treatment of NASH. 89bio has optimally
engineered BIO89-100 using a proprietary glycoPEGylation technology
to balance efficacy and longer dosing interval. Recent Phase 1b/2a
data show BIO89-100 demonstrated a favorable safety and
tolerability profile and robust reductions in liver fat and key
lipid markers when dosed weekly (QW) or once every two weeks (Q2W).
BIO89-100 is also being developed for the treatment of severe
hypertriglyceridemia (SHTG) and is currently in a Phase 2
trial.
About 89bio
89bio 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 a specifically engineered glycoPEGylated analog of
FGF21. BIO89-100 is being developed for the treatment of
nonalcoholic steatohepatitis (NASH) and severe hypertriglyceridemia
(SHTG). 89bio is headquartered in San Francisco with operations in
Herzliya, Israel.
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 and guidance regarding its business plans and
objectives for BIO89-100, including the therapeutic potential and
clinical benefits thereof, as well as the safety and tolerability
of BIO89-100 and future clinical development plans; its plans to
initiate an open-label histology cohort as part of the Phase 1b/2a
trial of BIO89-100 in NASH; expectations regarding BIO89-100’s
development path with regulatory authorities and timeline; the
expected timing of 89bio’s Phase 2b trial; and expectations
regarding timing for topline data. 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 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 and outcome of 89bio’s initiation of an open-label
histology cohort and Phase 2b trial; 89bio’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; the effect of the COVID-19 pandemic on 89bio’s
clinical trials and business operations, and the impact of general
economic, health, industrial or political conditions in the United
States or internationally; and other risks and uncertainties
identified in 89bio's Annual Report on Form 10-K for the year ended
December 31, 2019 and its Quarterly Report on Form 10-Q for the
quarter ended June 30, 2020 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) |
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
Nine Months
Ended |
|
|
September
30, |
|
September
30, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
11,208 |
|
$ |
6,680 |
|
$ |
27,429 |
|
$ |
14,154 |
General and administrative |
|
|
3,225 |
|
|
1,518 |
|
|
9,379 |
|
|
2,875 |
Total operating expenses |
|
|
14,433 |
|
|
8,198 |
|
|
36,808 |
|
|
17,029 |
Loss from
operations |
|
|
14,433 |
|
|
8,198 |
|
|
36,808 |
|
|
17,029 |
Other
expenses, net |
|
|
146 |
|
|
10,470 |
|
|
87 |
|
|
21,022 |
Net loss
before tax |
|
|
14,579 |
|
|
18,668 |
|
|
36,895 |
|
|
38,051 |
Income tax
expense |
|
|
24 |
|
|
57 |
|
|
23 |
|
|
86 |
Net
loss |
|
$ |
14,603 |
|
$ |
18,725 |
|
$ |
36,918 |
|
$ |
38,137 |
Comprehensive loss |
|
$ |
14,606 |
|
$ |
18,725 |
|
$ |
36,921 |
|
$ |
38,137 |
Net loss per
share, basic and diluted |
|
$ |
0.86 |
|
$ |
30.63 |
|
$ |
2.49 |
|
$ |
62.39 |
Weighted-average shares used to compute net loss per share, basic
and diluted |
|
|
16,884,244 |
|
|
611,226 |
|
|
14,809,131 |
|
|
611,226 |
|
|
|
|
|
|
|
|
|
89bio, Inc.
Condensed Consolidated Balance Sheet Data (Unaudited) (In
thousands) |
|
|
|
|
|
|
|
September
30, |
|
December
31, |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
Cash, cash
equivalents and short-term investments |
$ |
219,153 |
|
$ |
93,335 |
|
Total
assets |
|
223,428 |
|
|
95,553 |
|
Total
current liabilities |
|
9,424 |
|
|
5,609 |
|
Total
stockholders’ equity |
|
214,004 |
|
|
89,944 |
|
|
|
|
|
|
Investor Contact:Ryan MartinsChief Financial
Officerinvestors@89bio.com
Media Contact:Peter
Duckler773-343-3069pduckler@w2ogroup.com
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