Assembly Biosciences Reports Third Quarter 2020 Financial Results and Business Update
November 05 2020 - 4:02PM
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 a business update
for the third quarter ended September 30, 2020.
“We continue to make progress to develop our pipeline of core
inhibitor candidates for the treatment of patients with HBV,” said
John McHutchison, AO, MD, Chief Executive Officer and President of
Assembly Biosciences. “We have made great strides toward initiating
the vebicorvir Phase 3 registrational program, as well as advancing
ABI-H2158 and ABI-H3733, our more potent, next-generation core
inhibitor compounds, in the clinic.”
Recent Updates
HBV Portfolio
- Vebicorvir (VBR or ABI-H0731): Assembly
Bio’s lead core inhibitor candidate
- HBV field’s first core inhibitor combination study (Study 211)
to assess off-treatment response did not achieve a meaningful rate
of sustained virologic response (SVR) as 39 of 41 patients have
relapsed.
- Assembly Bio to host webcast and conference call today at 5:00
p.m. ET. The live audio webcast may be accessed through the “Events
& Presentations” page in the “Investors” section of Assembly
Bio’s website at
https://investor.assemblybio.com/events-presentations.
- For more information, see the data press release “Assembly Bio
Provides Update on the Ongoing Phase 2 Extension Study of
Vebicorvir in Patients with Chronic Hepatitis B Virus Infection”
issued today, available on Assembly Bio’s website.
- Reached agreement with the Chinese regulatory body, National
Medical Products Administration, Center for Drug Evaluation, and
advanced discussions with the U.S. Food and Drug Administration
(FDA) on a Phase 3 registrational program for VBR as a chronic
suppressive therapy (CST) for HBV infection.
- Entered into a license and collaboration agreement with
BeiGene, Ltd. for Assembly Bio’s portfolio of three clinical-stage
core inhibitors (VBR, ABI-H2158, ABI-H3733) in the China territory,
including Hong Kong, Macau and Taiwan.
- Entered into a clinical trial collaboration agreement with
Arbutus Biopharma Corporation to evaluate the triple combination of
VBR, RNAi therapeutic AB-729 and standard-of-care NrtI therapy in
patients with chronic HBV infection.
- Presented clinical data for Assembly Bio’s HBV core inhibitors
in an oral presentation and three posters at EASL 2020 The Digital
International Liver Congress™.
- ABI-H2158 (2158): Assembly Bio’s second core inhibitor
candidate
- Continued to enroll patients in the ongoing multi-center,
randomized, placebo-controlled Phase 2 trial to evaluate 2158 with
entecavir versus placebo with entecavir in treatment naïve patients
with HBeAg positive chronic HBV infection.
- ABI-H3733 (3733): Assembly Bio’s third core inhibitor candidate
- Continued the ongoing Phase 1 trial to evaluate the safety,
tolerability, and pharmacokinetics following single ascending dose
and multiple ascending dose administrations in healthy
subjects.
Corporate Highlights
- Appointed Gina Consylman to the Board
of Directors and Audit Committee in October 2020.
Anticipated Milestones
and Events
HBV Portfolio
- Four abstracts, including two
late-breaking submissions, will be presented at the annual meeting
of the American Association for Liver Diseases (AASLD), The Liver
Meeting® Digital Experience (TLMdX) being hosted virtually November
13-16, 2020.
- Vebicorvir
- Phase 3 registrational studies for CST
expected to initiate in H1 2021 in collaboration with BeiGene.
- Phase 2 triple combination study with
Arbutus Biopharma expected to initiate in H1 2021.
- Phase 2 triple combination study
evaluating the addition of interferon to VBR and NrtI expected to
initiate in H1 2021.
- Interim data from Phase 2
intensification study in partially virologically suppressed
patients anticipated in 2021.
- 2158
- Interim data from Phase 2 study
anticipated in 2021.
Upcoming Conference
- Jefferies Virtual London Healthcare
Conference: November 17-19, 2020.
Third Quarter 2020
Financial Results
- Cash, cash equivalents and
marketable securities were $237.9 million as of September
30, 2020, compared to $226.7 million as of June 30, 2020. This
increase is due to the $40.0 million upfront payment received in
July 2020 as part of the collaboration agreement with BeiGene
offset by cash used in operations. Assembly Bio’s cash position is
projected to fund operations into the second half of 2022.
- Revenues from
collaborative research were $34.6 million for the three months
ended September 30, 2020 compared to $4.2 million for the same
period in 2019. This includes the recognition of $31.0 million
under the collaboration agreement with BeiGene as well as
reimbursements incurred under the collaboration agreement with
AbbVie Inc. (Allergan Pharmaceuticals International Limited prior
to AbbVie’s acquisition of Allergan).
- Research and development
expenses were $26.9 million for the three months ended
September 30, 2020, compared to $21.7 million for the same period
in 2019. The increase was primarily due to an increase of $4.0
million in research and development expenses related to the HBV
program. Research and development expenses include non-cash
stock-based compensation expenses of $2.8 million for the three
months ended September 30, 2020 and $2.5 million for the same
period in 2019.
- General and administrative
expenses were $11.7 million for the three months ended
September 30, 2020 compared to $8.5 million for the same period in
2019. The increase was primarily due to an increase of $2.7 million
in professional fees associated with entering into the BeiGene
agreement. General and administrative expenses include non-cash
stock-based compensation expenses of $3.3 million for the three
months ended September 30, 2020 and $2.9 million for the same
period in 2019.
- Net loss attributable
to common stockholders was $3.3 million, or $0.09 per
basic and diluted share, for the three months ended September 30,
2020 compared to $25.0 million, or $0.96 per basic and diluted
share, for the same period in 2019.
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 Bio’s
fully integrated platform, including a robust process for strain
identification and selection, GMP manufacturing expertise 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 that are
subject to certain risks and uncertainties that could cause actual
results to materially differ. These risks and uncertainties
include: Assembly Bio’s ability to initiate and complete clinical
trials involving its HBV Cure and Microbiome therapeutic product
candidates in the currently anticipated timeframes; safety and
efficacy data from clinical studies may not warrant further
development of Assembly Bio’s product candidates; clinical and
nonclinical data presented at conferences may not differentiate
Assembly Bio’s product candidates from other companies’ candidates;
Assembly Bio may not observe sustained virologic response in
patients who stop therapy in Study 211; the timing and ability to
implement strategic alternatives with respect to Assembly Bio’s
Microbiome program; Assembly Bio’s ability to maintain financial
resources necessary to continue its clinical trials and fund
business operations; any impact that the spread of the coronavirus
and resulting COVID-19 pandemic may have on Assembly Bio’s business
and operations, including initiation and continuation of its
clinical trials or timing of discussions with regulatory
authorities; and other risks identified from time to time in
Assembly Bio’s reports filed with the U.S. Securities and Exchange
Commission (the SEC). You are urged to consider statements that
include the words may, will, would, could, should, might, believes,
hopes, estimates, projects, potential, expects, plans, anticipates,
intends, continues, forecast, designed, goal or the negative of
those words or other comparable words to be uncertain and
forward-looking. Assembly Bio 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. More
information about Assembly Bio’s risks and uncertainties are more
fully detailed under the heading “Risk Factors” in Assembly Bio's
filings with the SEC, including its most recent Annual Report on
Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on
Form 8-K. Except as required by law, Assembly Bio assumes no
obligation to update publicly any forward-looking statements,
whether as a result of new information, future events or
otherwise.
ContactsInvestor and Corporate:Lauren
GlaserSenior Vice President, Investor Relations and Corporate
Affairs(415) 521-3828lglaser@assemblybio.com
Media:Sam Brown Inc. Audra Friis (917) 519-9577
ASMBMedia@sambrown.com
ASSEMBLY
BIOSCIENCES, INC. |
CONDENSED
CONSOLIDATED BALANCE SHEETS |
(In
thousands except for share amounts and par value) |
|
|
|
|
|
September 30, |
|
December
31, |
|
2020 |
|
2019 |
|
(Unaudited) |
|
|
ASSETS |
|
|
|
Current
assets |
|
|
|
Cash and cash equivalents |
$ |
58,311 |
|
|
$ |
46,732 |
|
Marketable securities |
|
179,630 |
|
|
|
227,311 |
|
Accounts receivable from collaboration |
|
3,590 |
|
|
|
3,374 |
|
Prepaid expenses and other current assets |
|
4,856 |
|
|
|
5,363 |
|
Total
current assets |
|
246,387 |
|
|
|
282,780 |
|
|
|
|
|
Property and equipment, net |
|
1,904 |
|
|
|
1,830 |
|
Operating lease right-of-use (ROU) assets |
|
10,397 |
|
|
|
11,975 |
|
Other assets |
|
5,980 |
|
|
|
1,684 |
|
Indefinite-lived intangible asset |
|
29,000 |
|
|
|
29,000 |
|
Goodwill |
|
12,638 |
|
|
|
12,638 |
|
Total assets |
$ |
306,306 |
|
|
$ |
339,907 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current
liabilities |
|
|
|
Accounts payable |
$ |
1,611 |
|
|
$ |
1,731 |
|
Accrued clinical expenses |
|
4,451 |
|
|
|
4,826 |
|
Other accrued expenses |
|
7,404 |
|
|
|
8,286 |
|
Deferred revenue - short-term |
|
— |
|
|
|
6,411 |
|
Operating lease liabilities - short-term |
|
3,338 |
|
|
|
3,186 |
|
Total
current liabilities |
|
16,804 |
|
|
|
24,440 |
|
|
|
|
|
Deferred tax liabilities |
|
2,531 |
|
|
|
2,531 |
|
Deferred revenue - long-term |
|
8,987 |
|
|
|
30,637 |
|
Operating lease liabilities - long-term |
|
7,435 |
|
|
|
9,082 |
|
Total liabilities |
|
35,757 |
|
|
|
66,690 |
|
|
|
|
|
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, 2020 and December 31, 2019; 32,924,536 and
32,558,307 shares issued and outstanding as of September 30,
2020 and December 31, 2019, respectively |
|
33 |
|
|
|
32 |
|
Additional paid-in capital |
|
732,829 |
|
|
|
712,807 |
|
Accumulated other comprehensive loss |
|
(158 |
) |
|
|
(201 |
) |
Accumulated deficit |
|
(462,155 |
) |
|
|
(439,421 |
) |
Total stockholders' equity |
|
270,549 |
|
|
|
273,217 |
|
Total liabilities and stockholders' equity |
$ |
306,306 |
|
|
$ |
339,907 |
|
|
|
|
|
ASSEMBLY
BIOSCIENCES, INC. |
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME
(LOSS) |
(In thousands except
for share and per share amounts) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Collaboration revenue |
$ |
34,611 |
|
|
$ |
4,231 |
|
|
$ |
78,068 |
|
|
$ |
11,197 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
26,941 |
|
|
|
21,736 |
|
|
|
73,314 |
|
|
|
63,141 |
|
General and administrative |
|
11,689 |
|
|
|
8,488 |
|
|
|
29,888 |
|
|
|
22,085 |
|
Total
operating expenses |
|
38,630 |
|
|
|
30,224 |
|
|
|
103,202 |
|
|
|
85,226 |
|
Loss
from operations |
|
(4,019 |
) |
|
|
(25,993 |
) |
|
|
(25,134 |
) |
|
|
(74,029 |
) |
|
|
|
|
|
|
|
|
Other income |
|
|
|
|
|
|
|
Interest and other income, net |
|
670 |
|
|
|
983 |
|
|
|
2,400 |
|
|
|
3,446 |
|
Total other
income |
|
670 |
|
|
|
983 |
|
|
|
2,400 |
|
|
|
3,446 |
|
Loss
before income taxes |
|
(3,349 |
) |
|
|
(25,010 |
) |
|
|
(22,734 |
) |
|
|
(70,583 |
) |
|
|
|
|
|
|
|
|
Income tax
benefit |
|
— |
|
|
|
15 |
|
|
|
— |
|
|
|
33 |
|
Net
loss |
$ |
(3,349 |
) |
|
$ |
(24,995 |
) |
|
$ |
(22,734 |
) |
|
$ |
(70,550 |
) |
|
|
|
|
|
|
|
|
Other comprehensive (loss) income |
|
|
|
|
|
|
|
Unrealized (loss) gain on marketable securities, net of tax |
|
(262 |
) |
|
|
(18 |
) |
|
|
43 |
|
|
|
142 |
|
Comprehensive loss |
$ |
(3,611 |
) |
|
$ |
(25,013 |
) |
|
$ |
(22,691 |
) |
|
$ |
(70,408 |
) |
|
|
|
|
|
|
|
|
Net loss per
share, basic and diluted |
$ |
(0.09 |
) |
|
$ |
(0.96 |
) |
|
$ |
(0.64 |
) |
|
$ |
(2.74 |
) |
Weighted
average common shares outstanding, basic and diluted |
|
35,506,042 |
|
|
|
25,912,568 |
|
|
|
35,321,393 |
|
|
|
25,765,414 |
|
|
|
|
|
|
|
|
|
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