Assembly Biosciences Reports First Quarter 2019 Financial Results and Recent Highlights
May 09 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 for the first quarter
ended March 31, 2019 and provided a business update.
“We are dedicated to increasing cure rates for individuals with
chronic HBV and were honored to have data highlighting our deep
pipeline of novel core inhibitor candidates featured at The
International Liver Congress™ (ILC) last month, including our
ABI-H0731 presentation as a ‘Best of ILC’ selection,” said Derek
Small, President and Chief Executive Officer. “We showed interim
data from the ongoing Phase 2a trials of ‘731 demonstrating the
potential of core inhibitors in combination with Nuc therapy to be
the backbone of HBV cure regimens going forward, along with updates
on our next generation core inhibitor programs. Additionally, we
initiated a Phase 1b trial for our first microbiome clinical
program in collaboration with Allergan, with ABI-M201 now being
evaluated in ulcerative colitis patients.”
Mr. Small continued, “Our progress this year has helped us to
attract development veterans to our leadership team to support both
of our programs: Steven J. Knox as Senior Vice President Clinical
Development and David R. Houck, Ph.D., as Senior Vice President
Product Development and Portfolio Management. These additions
reflect our continued evolution into a clinical-stage organization
across both our HBV and microbiome programs, allowing us to focus
our resources on key pipeline priorities and improving our cash
runway.”
First Quarter 2019 and Recent Highlights
- Interim data from two ongoing Phase 2a trials of ABI-H0731
(‘731) in subjects with chronic HBV infection was presented at a
late-breaker oral session at ILC, The Annual Meeting of the
European Association for the Study of the Liver (EASL) in Vienna,
Austria. -- ‘731 in combination with nucleos(t)ide therapy
(Nuc) showed a favorable safety profile and the potential to
eliminate residual Hepatitis B Virus (DNA), one of the gating
factors to potentially reaching cure. -- Significant HBV
RNA declines were only observed in patients on ‘731 combination
therapy. -- In treatment naïve patients, accelerated and
significant declines in HBV DNA were observed starting as early as
Week 2. -- In Nuc-experienced, virally-suppressed
patients, HBV DNA reductions below the detectable limits of a
high-sensitivity PCR assay were observed only on combination
therapy with ‘731, an unprecedented finding in the field of HBV.
One treatment suppressed patient that achieved rapid DNA “target
not detected” and RNA decline to below the limit of quantitation
also demonstrated a greater than 0.5 log10 decline in HBeAg by Week
24. -- To prevent continual new infection and cccDNA
formation, elimination of residual viremia will likely be required
to increase cure rates.
- Additional data presentations at EASL included: -- A
Phase 1a study of next-generation core inhibitor ABI-H2158 (2158),
which demonstrated that 2158 was well tolerated and trough liver
concentrations are projected to achieve exposures in excess of the
in vitro EC50 (334nM) for cccDNA establishment with once daily
administration. A Phase 1b study in patients is
underway. -- Preclinical profile of ABI-H3733, the
Company’s third core inhibitor, which demonstrated increased
potency in blocking cccDNA formation. -- Additional data
from continuing longitudinal studies demonstrating that cccDNA
population turnover can occur in as little as 3-4 months, contrary
to historical estimates of up to 14 years. These results suggest
relatively rapid turnover of cccDNA pools and/or infected cells and
the potential to pursue cure in a defined treatment period with
targeted therapeutic regimens
- Strengthened clinical and product development
team: -- Steven J. Knox joined as Senior Vice President
Clinical Development. Mr. Knox is a 30-year clinical development
veteran that came to Assembly from Gilead Sciences where he most
recently served as Vice President, Clinical Research and was
responsible for global development programs in inflammation and
viral hepatitis, including for sofosbuvir (Sovaldi®) and
sofosbuvir/ledipasvir (Harvoni®), and tenofovir alafenamide
(Vemlidy®)1. -- David R. Houck, Ph.D. joined as Senior
Vice President Product Development and Portfolio Management. Mr.
Houck has more than 35 years of experience in the pharmaceutical
and biotechnology industries, from drug discovery through
submission of INDs and NDAs for both small molecules and biologics,
to manufacturing and quality control with particular experience in
anti-infective agents including HCV and HIV.
- Ongoing Phase 1b clinical trial of microbiome candidate M201
for mildly to moderately active ulcerative colitis (UC) at sites in
the U.S.
Anticipated Milestones and Events
HBV Program
- ABI-H0731 -- 24-week data from Phase 2a trials
combining ‘731 with Nuc therapy expected in Q4 2019, along with an
update on extended treatment of these patients in the open label
Study 211.
- ABI-H2158 -- Phase 1b trial in HBV-infected subjects
data expected by Q1 2020.
- ABI-H3733 -- Phase 1a trial expected to initiate in
Q1 2020.
Microbiome Program
- ABI-M201 -- Ongoing Phase 1b trial in patients with
mildly to moderately active UC.
- Microbiome Platform -- Leveraging discovery and
development capabilities and manufacturing expertise to advance new
proprietary candidates for other disease indications.
Upcoming Conferences
- Bank of America Merrill Lynch Health Care Conference 2019 in
Las Vegas, May 14-15, 2019.
- Jefferies 2019 Healthcare Conference in New York on June 5,
2019 at 9:00am ET.
First Quarter 2019 Financial Results
- Cash, cash equivalents and marketable
securities were approximately $193.5 million as of March
31, 2019, compared to approximately $218.1 million as of December
31, 2018. This quarter-end cash position is projected to fund
operations into 2021.
- Revenues from collaborative research were
approximately $3.9 million for the three months ended March 31,
2019 compared to $3.6 million for the same period in
2018.
- Research and development expenses, excluding
stock-based compensation expense, were approximately $20.0 million
for the three months ended March 31, 2019, compared to
approximately $12.0 million for the same period in 2018. This
increase was primarily due to an increase of approximately $6.4
million in research and development expenses related to the HBV
program and an increase of approximately $1.6 million in research
and development expenses related to the microbiome program.
Stock-based compensation expense was approximately $2.7 million for
the three months ended March 31, 2019, compared to approximately
$2.5 million for the same period in 2018.
- General and administrative expenses, excluding
stock-based compensation expense, were approximately $5.7 million
for the three months ended March 31, 2019, compared to $4.1 million
for the same period in 2018. The increase was primarily due to
increases in professional fees, employee-related expenses and
facility expenses associated with the Company’s new offices in
South San Francisco. Stock-based compensation expense was
approximately $3.8 million for the three months ended March 31,
2019, compared to approximately $1.6 million for the same period in
2018.
- Net loss attributable to common stockholders
was approximately $27.1 million, or $1.05 per basic and diluted
share, for the three months ended March 31, 2019, compared to
approximately $16.3 million, or $0.80 per basic and diluted share,
for the same period in 2018. The increase was primarily due to an
increase in research and development expenses related to the HBV
program, expenses related to non-cash, stock-based compensation,
employee incentive programs and increased headcount across the
organization.
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 synthetic 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,” “may,” “will,” “projected” and “potential.” 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; our anticipated capital
expenditures and our estimates regarding our capital requirements;
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 March 31, 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.
1Sovaldi®, Harvoni® and Vemlidy® are registered trademarks of
Gilead Sciences, Inc., or its related companies.
Contacts Assembly Biosciences, Inc. Investors:
Lauren Glaser (415) 521-3828 lglaser@assemblybio.com
ASSEMBLY BIOSCIENCES, INC. |
CONDENSED CONSOLIDATED BALANCE SHEETS |
($ in thousands except for share and per share
amounts) |
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2019 |
|
|
|
2018 |
|
|
(Unaudited) |
|
|
ASSETS |
|
|
|
Current assets |
|
|
|
Cash and cash equivalents |
$ |
29,107 |
|
|
$ |
41,471 |
|
Marketable securities |
|
164,429 |
|
|
|
176,609 |
|
Accounts receivable from collaboration |
|
2,987 |
|
|
|
2,430 |
|
Prepaid expenses and other current assets |
|
4,283 |
|
|
|
1,992 |
|
Total current assets |
|
200,806 |
|
|
|
222,502 |
|
|
|
|
|
Property and equipment, net |
|
2,079 |
|
|
|
557 |
|
Operating lease right-of-use assets |
|
13,063 |
|
|
|
- |
|
Other assets |
|
1,661 |
|
|
|
3,348 |
|
Indefinite-lived intangible asset |
|
29,000 |
|
|
|
29,000 |
|
Goodwill |
|
12,638 |
|
|
|
12,638 |
|
Total
assets |
$ |
259,247 |
|
|
$ |
268,045 |
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
Current liabilities |
|
|
|
Accounts payable |
$ |
2,427 |
|
|
$ |
3,693 |
|
Accrued expenses |
|
10,141 |
|
|
|
9,679 |
|
Deferred revenue - short-term |
|
9,933 |
|
|
|
5,100 |
|
Operating lease liabilities - short-term |
|
2,704 |
|
|
|
- |
|
Total current liabilities |
|
25,205 |
|
|
|
18,472 |
|
|
|
|
|
Deferred rent |
|
- |
|
|
|
108 |
|
Deferred tax liabilities |
|
3,252 |
|
|
|
3,252 |
|
Deferred revenue - long-term |
|
29,868 |
|
|
|
35,560 |
|
Operating lease liabilities - long-term |
|
10,521 |
|
|
|
- |
|
Total
liabilities |
|
68,846 |
|
|
|
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
March 31, 2019 and December 31, 2018; 25,549,757 and 25,495,425
shares issued and outstanding as of March 31, 2019 and December 31,
2018, respectively |
|
26 |
|
|
|
25 |
|
Additional paid-in capital |
|
559,453 |
|
|
|
552,762 |
|
Accumulated other comprehensive loss |
|
(239 |
) |
|
|
(347 |
) |
Accumulated deficit |
|
(368,839 |
) |
|
|
(341,787 |
) |
Total stockholders' equity |
|
190,401 |
|
|
|
210,653 |
|
Total liabilities and
stockholders' equity |
$ |
259,247 |
|
|
$ |
268,045 |
|
|
|
|
|
ASSEMBLY BIOSCIENCES, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS |
($ in thousands except for share and per share amounts) |
(Unaudited) |
|
|
|
|
|
|
|
Three Months Ended March 31, |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
Collaboration
revenue |
|
$ |
3,885 |
|
|
$ |
3,565 |
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
Research and development |
|
|
22,704 |
|
|
|
14,541 |
|
General and administrative |
|
|
9,517 |
|
|
|
5,696 |
|
Total operating expenses |
|
|
32,221 |
|
|
|
20,237 |
|
Loss from
operations |
|
|
(28,336 |
) |
|
|
(16,672 |
) |
|
|
|
|
|
Other income (expenses) |
|
|
|
|
Interest and other income |
|
|
1,276 |
|
|
|
446 |
|
Other income (expense), net |
|
|
1 |
|
|
|
(23 |
) |
Total other income |
|
|
1,277 |
|
|
|
423 |
|
Loss before
income taxes |
|
|
(27,059 |
) |
|
|
(16,249 |
) |
|
|
|
|
|
Income tax benefit |
|
|
7 |
|
|
|
- |
|
Net
loss |
|
$ |
(27,052 |
) |
|
$ |
(16,249 |
) |
|
|
|
|
|
Other
comprehensive (loss) income |
|
|
|
|
Unrealized gain (loss) on marketable securities, net of tax |
|
|
108 |
|
|
|
(67 |
) |
Comprehensive
loss |
|
$ |
(26,944 |
) |
|
$ |
(16,316 |
) |
|
|
|
|
|
Net loss per share, basic and
diluted |
|
$ |
(1.05 |
) |
|
$ |
(0.80 |
) |
|
|
|
|
|
Weighted average common shares
outstanding, basic and diluted |
|
|
25,668,798 |
|
|
|
20,231,804 |
|
|
|
|
|
|
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