Assembly Biosciences Reports Second Quarter 2019 Financial Results and Recent Highlights
August 05 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 second quarter ended June 30, 2019.
“The second quarter of 2019 has been a period of great progress
as we continue our transition into later stage clinical
development. Following a series of data presentations at EASL in
Vienna and IASL in China, we have continued to progress our HBV
clinical candidates, now on a global scale,” said Derek Small,
President and Chief Executive Officer. “We are also excited
that the first oral microbiome biologic drug candidate from our
proprietary platform is being evaluated in patients, with our Phase
1b clinical trial of ABI-M201 for mildly to moderately active
ulcerative colitis underway.” Second Quarter
2019 and Recent Highlights
- Oral presentation, “New Therapies to More Effectively Eliminate
Viral Replication and Increase Cure Rates in CHB Patients,” at the
first International Association for the Study of the Liver (IASL)
Congress on June 22, 2019 in Beijing, China by Richard Colonno, EVP
and CSO of Virology Operations. • Reviewed science and
strategies for utilizing HBV core inhibitors as well as interim
clinical data previously reported by the company in April 2019 at
The International Liver Congress™(ILC), the Annual Meeting of the
European Association for the Study of the Liver (EASL).
- Received Clinical Trial Application (CTA) approvals from
China’s Center for Drug Evaluation (CDE), part of the National
Medical Products Administration (NMPA) in China, enabling
Assembly’s plans to initiate Phase 2 and Phase 1 clinical trials of
both 731 and 2158, respectively, at leading HBV trial sites in
China.
- Dosed first patient with ABI-H2158 in Phase 1b dose escalation
study in HBV patients.
- Dosed first patient with ABI-M201 in a Phase 1b clinical trial
for mildly to moderately active ulcerative colitis (UC).
• First oral microbiome biologic drug candidate from
Assembly’s proprietary microbiome platform to enter clinical trials
in patients.
- Steve Knox, SVP, Clinical Development and David Houck, PhD, SVP
Product Development & Portfolio Management joined Assembly’s
leadership team as the company transitions to a later stage
development organization.
Anticipated Milestones and Events
HBV Program
- ABI-H0731 • Additional data from the ongoing
long-term Phase 2a trial combining 731 with Nuc therapy, including
48-week interim results, expected in Q4 2019.
- ABI-H2158 • Data from Phase 1b trial in
HBV-infected subjects expected 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
UC.
- Microbiome Platform • Leveraging discovery and
development capabilities and manufacturing expertise to advance new
proprietary candidates for other disease
indications.
Upcoming Conferences
- Baird’s 2019 Global Healthcare Conference, in New York on
September 5, 2019 at 10:15am ET
Second Quarter 2019 Financial Results
- Cash, cash equivalents and marketable
securities were approximately $173.8 million as of June
30, 2019, compared to approximately $193.5 million as of March 31,
2019. This quarter-end cash position is projected to fund
operations into 2021.
- Revenues from collaborative research were
approximately $3.1 million for the three months ended June 30, 2019
compared to $3.2 million for the same period in 2018.
- Research and development expenses, excluding
stock-based compensation expense, were approximately $15.6 million
for the three months ended June 30, 2019, compared to approximately
$14.2 million for the same period in 2018. Stock-based compensation
expense was approximately $3.1 million for the three months ended
June 30, 2019, compared to approximately $3.7 million for the same
period in 2018.
- General and administrative expenses, excluding
stock-based compensation expense, were approximately $5.1 million
for the three months ended June 30, 2019, compared to $4.6 million
for the same period in 2018. Stock-based compensation expense was
approximately $(1.1) million for the three months ended June 30,
2019, compared to approximately $7.9 million for the same period in
2018. This decrease was primarily due to the reversal of previously
recognized expense of $3.6 million related to forfeited awards to a
former officer who departed during the most recent period coupled
with a $4.3 million one-time expense related to the departure and
transition to consultant of a former officer in 2018.
- Net loss attributable to common stockholders
was approximately $18.5 million, or $0.72 per basic and diluted
share, for the three months ended June 30, 2019, compared to
approximately $26.8 million, or $1.30 per basic and diluted share,
for the same period in 2018.
About Assembly BiosciencesAssembly
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; 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 June 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. |
|
|
CONDENSED CONSOLIDATED BALANCE SHEETS |
|
|
($ in thousands except for share and per share
amounts) |
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
(Unaudited) |
|
|
|
|
ASSETS |
|
|
|
|
|
Current assets |
|
|
|
|
|
Cash and cash equivalents |
$ |
34,258 |
|
|
$ |
41,471 |
|
|
|
Marketable securities |
|
139,553 |
|
|
|
176,609 |
|
|
|
Accounts receivable from collaboration |
|
2,903 |
|
|
|
2,430 |
|
|
|
Prepaid expenses and other current assets |
|
6,746 |
|
|
|
1,992 |
|
|
|
Total current assets |
|
183,460 |
|
|
|
222,502 |
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
2,048 |
|
|
|
557 |
|
|
|
Operating lease right-of-use assets |
|
12,672 |
|
|
|
- |
|
|
|
Other assets |
|
1,693 |
|
|
|
3,348 |
|
|
|
Indefinite-lived intangible asset |
|
29,000 |
|
|
|
29,000 |
|
|
|
Goodwill |
|
12,638 |
|
|
|
12,638 |
|
|
|
Total
assets |
$ |
241,511 |
|
|
$ |
268,045 |
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY |
|
|
|
|
|
Current liabilities |
|
|
|
|
|
Accounts payable |
$ |
3,414 |
|
|
$ |
3,693 |
|
|
|
Accrued expenses |
|
7,585 |
|
|
|
9,679 |
|
|
|
Deferred revenue - short-term |
|
6,082 |
|
|
|
5,100 |
|
|
|
Operating lease liabilities - short-term |
|
2,854 |
|
|
|
- |
|
|
|
Total current liabilities |
|
19,935 |
|
|
|
18,472 |
|
|
|
|
|
|
|
|
|
Deferred rent |
|
- |
|
|
|
108 |
|
|
|
Deferred tax liabilities |
|
3,252 |
|
|
|
3,252 |
|
|
|
Deferred revenue - long-term |
|
33,582 |
|
|
|
35,560 |
|
|
|
Operating lease liabilities - long-term |
|
10,035 |
|
|
|
- |
|
|
|
Total
liabilities |
|
66,804 |
|
|
|
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
June 30, 2019 and December 31, 2018; 25,646,783 and 25,495,425
shares issued and outstanding as of June 30, 2019 and December 31,
2018, respectively |
|
26 |
|
|
|
25 |
|
|
|
Additional paid-in capital |
|
562,210 |
|
|
|
552,762 |
|
|
|
Accumulated other comprehensive loss |
|
(187 |
) |
|
|
(347 |
) |
|
|
Accumulated deficit |
|
(387,342 |
) |
|
|
(341,787 |
) |
|
|
Total stockholders' equity |
|
174,707 |
|
|
|
210,653 |
|
|
|
Total liabilities and
stockholders' equity |
$ |
241,511 |
|
|
$ |
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 June 30, |
|
Six Months Ended June 30, |
|
|
|
|
|
2019 |
|
|
|
2018 |
|
|
|
2019 |
|
|
|
2018 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration
revenue |
|
$ |
3,080 |
|
|
$ |
3,218 |
|
|
$ |
6,966 |
|
|
$ |
6,783 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
18,700 |
|
|
|
17,840 |
|
|
|
41,405 |
|
|
|
32,381 |
|
|
|
General and administrative |
|
|
4,080 |
|
|
|
12,544 |
|
|
|
13,597 |
|
|
|
18,240 |
|
|
|
Total operating
expenses |
|
|
22,780 |
|
|
|
30,384 |
|
|
|
55,002 |
|
|
|
50,621 |
|
|
|
Loss from
operations |
|
|
(19,700 |
) |
|
|
(27,166 |
) |
|
|
(48,036 |
) |
|
|
(43,838 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income
(expenses) |
|
|
|
|
|
|
|
|
|
|
Interest and other income |
|
|
1,182 |
|
|
|
453 |
|
|
|
2,458 |
|
|
|
899 |
|
|
|
Other income (expense), net |
|
|
4 |
|
|
|
(127 |
) |
|
|
5 |
|
|
|
(150 |
) |
|
|
Total other
income |
|
|
1,186 |
|
|
|
326 |
|
|
|
2,463 |
|
|
|
749 |
|
|
|
Loss before income
taxes |
|
|
(18,514 |
) |
|
|
(26,840 |
) |
|
|
(45,573 |
) |
|
|
(43,089 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax
benefit |
|
|
11 |
|
|
|
34 |
|
|
|
18 |
|
|
|
34 |
|
|
|
Net
loss |
|
$ |
(18,503 |
) |
|
$ |
(26,806 |
) |
|
$ |
(45,555 |
) |
|
$ |
(43,055 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive (loss)
income |
|
|
|
|
|
|
|
|
|
|
Unrealized gain on marketable securities, net of
tax |
|
|
52 |
|
|
|
87 |
|
|
|
160 |
|
|
|
20 |
|
|
|
Comprehensive
loss |
|
$ |
(18,451 |
) |
|
$ |
(26,719 |
) |
|
$ |
(45,395 |
) |
|
$ |
(43,035 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and
diluted |
|
$ |
(0.72 |
) |
|
$ |
(1.30 |
) |
|
$ |
(1.77 |
) |
|
$ |
(2.11 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common shares
outstanding, basic and diluted |
|
|
25,740,500 |
|
|
|
20,541,549 |
|
|
|
25,690,617 |
|
|
|
20,387,532 |
|
|
|
|
|
|
|
|
|
|
|
|
|
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