Assembly Biosciences Reports Third Quarter 2019 Financial Results and Recent Highlights
November 07 2019 - 4:05PM
Assembly Biosciences, Inc. (NASDAQ: ASMB), a clinical-stage
biotechnology company developing innovative therapeutics targeting
hepatitis B virus (HBV) and diseases associated with the
microbiome, today reported financial results and recent highlights
for the third quarter ended September 30, 2019.
“I’m thrilled to have joined Assembly during the third quarter;
this is an exciting time as our HBV and microbiome programs are
building important momentum. We have also had the opportunity to
attract industry-leading talent to our team with the recent
additions of Tom Russo as CFO and Luisa Stamm as CMO,” said John
McHutchison, AO, MD, Chief Executive Officer and President. “We
look forward to presenting data from our Phase 2a trials of
ABI-H0731 in more detail on Monday, November 11, during the AASLD
Annual Meeting in Boston. As our abstract indicated, the
combination of ‘731 with nucleos(t)ide therapy not only showed
superior antiviral activity to nucleos(t)ide therapy alone, but is
also associated with declines in surrogate markers predictive of
cccDNA pool depletion, suggesting our core inhibitor regimens may
be on the path to HBV cure. We also continue to advance our second
and third core inhibitor candidates, with interim data from the
Phase 1b trial of 2158 scheduled for presentation at
AASLD.”
Third Quarter 2019 and Recent Highlights
- Abstracts with data highlighting safety and antiviral activity
of Assembly’s first and second generation core inhibitor candidates
in the treatment of chronic HBV were accepted for late-breaking
posters at the upcoming American Association for the Study of Liver
Diseases (AASLD) Annual Meeting (The Liver Meeting®) in
Boston.° Phase 2a studies of ABI-H0731 + nucleos(t)ide
analogs (Nrtl) in HBeAg+ patients show faster and deeper declines
in HBV DNA and pgRNA with combination than Nrtl alone, as well as
subsequent declines in the surrogate markers of cccDNA with
long-term treatment° Potent antiviral activity was observed
in first cohort of HBeAg+ patients treated in 14-day monotherapy
study of ABI-H2158° The posters will be displayed during the
8:00am-5:30pm ET session on Monday, November 11, 2019, with
presentation scheduled from 12:30-1:30pm ET.
- John McHutchison, AO, MD, joined Assembly in August as Chief
Executive Officer and President. Dr. McHutchison is a
world-renowned hepatologist, gastroenterologist, and anti-viral
drug developer who previously led the research and development of
five marketed therapies for chronic hepatitis B and chronic
hepatitis C.
- Further strengthened the leadership team with appointments of
Thomas Russo as Chief Financial Officer in October and Luisa Stamm,
MD, PhD as Chief Medical Officer, as announced separately
today.° Mr. Russo brings 25 years of experience in the
biotechnology and pharmaceutical industry, spanning finance and
operations (including commercial planning and manufacturing), as
well as equity research.° Dr. Stamm is an infectious disease
specialist whose industry career has focused on the development of
therapeutics for hepatitis C (HCV) and liver disease, as well as
HIV and other viral diseases.
Anticipated Milestones and Events HBV
Program
- ABI-H0731° Data from the ongoing long-term open label
extension Phase 2 trial, Study 211, combining 731 with Ntrl
therapy, including 48-week interim results, as well as final 24
week data from Studies 201 and 202 to be presented at AASLD on
November 11, 2019.
- ABI-H2158° Data from the initial dose cohort in the Phase
1b trial in HBV-infected subjects to be presented at AASLD on
November 11, 2019. Full study data anticipated in Q1 2020.
- ABI-H3733° Phase 1a trial expected to initiate in Q1
2020.
Microbiome Program
- ABI-M201° Enrollment and dosing ongoing in Phase 1b trial
in patients with mildly to moderately active ulcerative colitis
(UC).
- Microbiome Platform° Leveraging discovery and development
capabilities and manufacturing expertise to advance new proprietary
candidates for multiple other disease
indications.
Upcoming Events and Conferences
- Conference call on Monday, November 11, 2019 at 8:30am ET to
review AASLD data
- William Blair Biotech Focus Day Series: Boston Area Innovation
on November 12, 2019
- Jefferies London Healthcare Conference, November 20-21,
2019
- Hep-DART, December 8-12, 2019 in Kauai, HI
Upcoming Conference Call and Webcast InformationAssembly will
host a live conference call and audio webcast on Monday, November
11, 2019, at 8:30am ET following the start of the late breaking
poster session at the AASLD meeting. The live audio webcast can be
accessed through the Events & Presentations page in the
Investors section of the company's website at assemblybio.com.
Alternatively, participants can dial (866) 438-0453 (domestic) or
(409) 220-9366 (international) and refer to conference ID
4283686.
Third Quarter 2019 Financial Results
- Cash, cash equivalents and marketable
securities were approximately $156.9 million as of
September 30, 2019, compared to approximately $173.8 million as of
June 30, 2019. This quarter-end cash position is projected to fund
operations into 2021.
- Revenues from collaborative research were
approximately $4.2 million for the three months ended September 30,
2019 compared to $4.3 million for the same period in 2018.
- Research and development expenses, excluding
stock-based compensation expense, were approximately $19.3 million
for the three months ended September 30, 2019, compared to
approximately $16.6 million for the same period in 2018.
Stock-based compensation expense was approximately $2.5 million for
the three months ended September 30, 2019 and 2018.
- General and administrative expenses, excluding
stock-based compensation expense, were approximately $5.5 million
for the three months ended September 30, 2019, compared to $4.2
million for the same period in 2018. Stock-based compensation
expense was approximately $2.9 million for the three months ended
September 30, 2019, compared to approximately $3.5 million for the
same period in 2018.
- Net loss attributable to common stockholders
was approximately $25.0 million, or $0.96 per basic and diluted
share, for the three months ended September 30, 2019, compared to
approximately $21.5 million, or $0.87 per basic and diluted share,
for the same period in 2018.
About Assembly Biosciences Assembly
Biosciences, Inc. is a clinical-stage biotechnology company
developing innovative therapeutics targeting hepatitis B virus
(HBV) and diseases associated with the microbiome. The HBV program
is focused on advancing a new class of potent, oral core inhibitors
that have the potential to increase cure rates for chronically
infected patients. The microbiome program is developing novel
oral live microbial biotherapeutic candidates with Assembly’s fully
integrated platform, including a robust process for strain
identification and selection, GMP banking and production, and
targeted delivery to the lower gastrointestinal tract with the
GEMICEL® technology. For more information,
visit assemblybio.com.
Forward-Looking Statements The information in
this press release contains forward-looking statements regarding
future events, including statements about the clinical and
therapeutic potential of core inhibitors, the timing of the
initiation of and the availability of data from our ongoing and
planned clinical trials and cash projections. Certain
forward-looking statements may be identified by reference to a
future period or by use of forward-looking terminology such as
“expected,” “plans,” “potential” and “projected.” Assembly intends
such forward-looking statements to be covered by the safe harbor
provisions contained in Section 27A of the Securities Act of 1933,
as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended. Actual results or developments may differ materially
from those projected or implied in these forward-looking
statements. These risks and uncertainties include, among others:
the components, timing, cost and results of clinical trials and
other development activities involving our product candidates
(including those licensed by Allergan Pharmaceuticals International
Limited); the unpredictability of the preclinical and clinical
development of our product candidates and of the duration and
results of regulatory review of those candidates by the FDA and
foreign regulatory authorities; whether our cash resources will be
sufficient to fund continuing operations for the periods and/or
trials; and the possible impairment of, or inability to obtain,
intellectual property rights and the costs of obtaining such rights
from third parties. More information about the risks and
uncertainties faced by Assembly are more fully detailed under the
heading “Risk Factors” in Assembly's Quarterly Report on Form 10-Q
for the quarter ended September 30, 2019 filed with the Securities
and Exchange Commission. Except as required by law, Assembly
assumes no obligation to update publicly any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Contacts Assembly Biosciences, Inc. Investors:
Lauren Glaser (415) 521-3828 lglaser@assemblybio.com
Assembly Biosciences, Inc. |
|
|
|
Balance Sheet |
|
|
|
For
the Period Ended September 30, 2019 |
|
|
|
|
|
|
|
|
Rounded |
|
September 30, |
|
December 31, |
|
2019 |
|
2018 |
|
(Unaudited) |
|
|
ASSETS |
|
|
|
Current
assets |
|
|
|
Cash and cash equivalents |
$ |
24,867 |
|
|
$ |
41,471 |
|
Marketable securities |
|
132,070 |
|
|
|
176,609 |
|
Accounts receivable from collaboration |
|
2,944 |
|
|
|
2,430 |
|
Prepaid expenses and other current assets |
|
5,441 |
|
|
|
1,992 |
|
Total
current assets |
|
165,322 |
|
|
|
222,502 |
|
Property and equipment, net |
|
1,931 |
|
|
|
557 |
|
Operating lease right-of-use assets |
|
12,783 |
|
|
|
— |
|
Other assets |
|
1,671 |
|
|
|
3,348 |
|
Indefinite-lived intangible asset |
|
29,000 |
|
|
|
29,000 |
|
Goodwill |
|
12,638 |
|
|
|
12,638 |
|
Total assets |
$ |
223,345 |
|
|
$ |
268,045 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current
liabilities |
|
|
|
Accounts payable |
$ |
2,709 |
|
|
$ |
3,693 |
|
Accrued expenses |
|
9,430 |
|
|
|
9,679 |
|
Deferred revenue - short-term |
|
6,151 |
|
|
|
5,100 |
|
Operating lease liabilities - short-term |
|
3,208 |
|
|
|
— |
|
Total
current liabilities |
|
21,498 |
|
|
|
18,472 |
|
Deferred rent |
|
— |
|
|
|
108 |
|
Deferred tax liabilities |
|
3,251 |
|
|
|
3,252 |
|
Deferred revenue - long-term |
|
32,268 |
|
|
|
35,560 |
|
Operating lease liabilities - long-term |
|
9,839 |
|
|
|
— |
|
Total liabilities |
|
66,856 |
|
|
|
57,392 |
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
Stockholders' equity |
|
|
|
Preferred stock, $0.001 par value; 5,000,000 shares authorized; no
shares issued or outstanding |
|
— |
|
|
|
— |
|
Common stock, $0.001 par value; 100,000,000 shares authorized as of
September 30, 2019 and December 31, 2018; 25,872,723 and 25,495,425
shares issued and outstanding as of September 30, 2019 and December
31, 2018, respectively |
|
26 |
|
|
|
25 |
|
Additional paid-in capital |
|
569,005 |
|
|
|
552,762 |
|
Accumulated other comprehensive loss |
|
(205 |
) |
|
|
(347 |
) |
Accumulated deficit |
|
(412,337 |
) |
|
|
(341,787 |
) |
Total stockholders' equity |
|
156,489 |
|
|
|
210,653 |
|
Total liabilities and stockholders' equity |
$ |
223,345 |
|
|
$ |
268,045 |
|
|
|
|
|
Assembly Biosciences, Inc. |
|
|
|
|
|
|
|
Income Statement |
|
|
|
|
|
|
|
For
the Period Ended September 30, 2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rounded |
|
Rounded |
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Collaboration revenue |
$ |
4,231 |
|
|
$ |
4,286 |
|
|
$ |
11,197 |
|
|
$ |
11,069 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
21,736 |
|
|
|
19,109 |
|
|
|
63,141 |
|
|
|
51,490 |
|
General and administrative |
|
8,488 |
|
|
|
7,752 |
|
|
|
22,085 |
|
|
|
25,992 |
|
Total
operating expenses |
|
30,224 |
|
|
|
26,861 |
|
|
|
85,226 |
|
|
|
77,482 |
|
Loss
from operations |
|
(25,993 |
) |
|
|
(22,575 |
) |
|
|
(74,029 |
) |
|
|
(66,413 |
) |
|
|
|
|
|
|
|
|
Other income (expenses) |
|
|
|
|
|
|
|
Interest and other income |
|
983 |
|
|
|
1,116 |
|
|
|
3,441 |
|
|
|
2,015 |
|
Other income (expense), net |
|
- |
|
|
|
(82 |
) |
|
|
5 |
|
|
|
(232 |
) |
Total other
income |
|
983 |
|
|
|
1,034 |
|
|
|
3,446 |
|
|
|
1,783 |
|
Loss
before income taxes |
|
(25,010 |
) |
|
|
(21,541 |
) |
|
|
(70,583 |
) |
|
|
(64,630 |
) |
|
|
|
|
|
|
|
|
Income tax
benefit |
|
15 |
|
|
|
6 |
|
|
|
33 |
|
|
|
40 |
|
Net
loss |
$ |
(24,995 |
) |
|
$ |
(21,535 |
) |
|
$ |
(70,550 |
) |
|
$ |
(64,590 |
) |
|
|
|
|
|
|
|
|
Other comprehensive (loss) income |
|
|
|
|
|
|
|
Unrealized gain (loss) on marketable securities, net of tax |
|
(18 |
) |
|
|
17 |
|
|
|
142 |
|
|
|
37 |
|
Comprehensive loss |
$ |
(25,013 |
) |
|
$ |
(21,518 |
) |
|
$ |
(70,408 |
) |
|
$ |
(64,553 |
) |
|
|
|
|
|
|
|
|
Net loss per
share, basic and diluted |
$ |
(0.96 |
) |
|
$ |
(0.87 |
) |
|
$ |
(2.74 |
) |
|
$ |
(2.95 |
) |
Weighted
average common shares outstanding, basic and diluted |
|
25,912,568 |
|
|
|
24,878,413 |
|
|
|
25,765,414 |
|
|
|
21,900,943 |
|
|
|
|
|
|
|
|
|
Assembly Biosciences (NASDAQ:ASMB)
Historical Stock Chart
From Mar 2024 to Apr 2024
Assembly Biosciences (NASDAQ:ASMB)
Historical Stock Chart
From Apr 2023 to Apr 2024