Assembly Biosciences Reports Fourth Quarter and Year End 2020 Financial Results and Recent Highlights
February 25 2021 - 4:05PM
Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage
biotechnology company developing innovative therapeutics targeting
hepatitis B virus (HBV), today reported financial results and
recent highlights for the fourth quarter and year ended December
31, 2020.
“Our strategy for 2021 and beyond is to focus entirely on
developing finite and curative therapies that have the potential to
free patients with chronic HBV infection from a lifetime of
therapy. We are well positioned to do this by advancing our more
potent next generation core inhibitors, which include three novel
compounds in the clinic and a fourth candidate in pre-IND
development, exploring multiple triple combination studies of
vebicorvir with complementary mechanisms of action, and expanding
our internal research efforts to discover and develop candidates
against novel targets,” said John McHutchison, AO, MD, Chief
Executive Officer and President of Assembly Bio.
Fourth Quarter 2020 and Recent Highlights
- Strategy and resources fully focused on pursuing finite and
curative therapies for chronic HBV:• As announced separately
today, Assembly Bio will forgo initiation of Phase 3 registrational
studies of vebicorvir (VBR) as a chronic suppressive therapy to
concentrate research and development efforts on identifying a
finite and curative therapy.• By directing all resources to
support its finite and curative strategy, the company expects to
advance these initiatives more quickly, while simultaneously
extending its cash runway into 2023.• Assembly Bio is hosting
a 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.
- Initiated a Phase 2 triple combination study evaluating the
addition of peg-IFNα to the VBR+ nucleos(t)ide analog reverse
transcriptase inhibitor (NrtI) antiviral backbone in patients with
chronic HBV infection.
- Entered into collaboration with Door Pharmaceuticals to
discover and develop a novel class of HBV cccDNA disruptors that
target different phases of the HBV replication cycle distinct from
and complementary to those targeted by Assembly Bio’s existing
pipeline compounds.
- Presented four posters at the American Association for the
Study of Liver Diseases (AASLD) Annual Meeting in November 2020,
including data from the company’s HBV core inhibitor research and
development programs, as well as a collaborative translational
study using Assembly Bio’s sensitive HBV nucleic acid assays.
- Reported data in early November 2020 from Study 211 on the dual
combination of VBR+Nrtl to assess off-treatment response in
patients with chronic HBV infection, which did not achieve a
meaningful rate of sustained virologic response (SVR).
- Substantially completed wind-down of Assembly Bio’s Microbiome
program.
- Appointed Nicole S. White, PhD, as Senior Vice President of
Pharmaceutical Development and Manufacturing.
- Appointed Gina Consylman, Senior Vice President, Chief
Financial Officer of Ironwood Pharmaceuticals, Inc. to Board
of Directors.
2021 Key Objectives and Anticipated
Progress
- Initiate Phase 2 triple combination study with Arbutus
Biopharma Corporation evaluating VBR, RNAi therapeutic AB-729, and
NrtI therapy in virologically-suppressed patients in H1 2021.
- Nominate a best-in-class fourth core inhibitor candidate in H1
2021.
- Anticipate interim data from Phase 2 study with ABI-H2158 in H2
2021.
- Expect to progress two additional internal programs evaluating
differentiated and undisclosed targets.
Fourth Quarter 2020 and Year End Financial
Results
- Cash, cash equivalents and marketable
securities were $216.4 million as of December 31, 2020,
compared to $237.9 million as of September 30, 2020, and $274.0
million as of the year ended December 31, 2019. This result
includes the $5.5 million of net proceeds from the issuance of
common shares under Assembly Bio’s at-the-market (ATM) program.
Subsequently, net proceeds from Assembly Bio’s ATM program during
January and February 2021 to-date were $25.5 million. The company’s
cash position is projected to fund operations into 2023.
- Revenues from collaborative research were $1.0
million for the three months ended December 31, 2020, compared to
$4.8 million for the same period in 2019, and $79.1 million for the
year ended December 31, 2020, compared to $16.0 million in 2019.
The year-over-year increase was primarily due to the $31.0 million
recognized under the collaboration agreement with BeiGene, Ltd.
(BeiGene) and the remaining deferred revenue balance of $37.0
million incurred under the collaboration agreement with Abbvie Inc.
(Allergan Pharmaceuticals International Limited prior to Abbvie’s
acquisition of Allergan).
- Research and development expenses were $33.5
million for the three months ended December 31, 2020, compared to
$22.6 million for the same period in 2019, and $106.8 million for
the year ended December 31, 2020, compared to $85.8 million in
2019. The increase was primarily due to an increase of $14.4
million in research and development expenses related to the HBV
program and one-time expenses of $5.7 million related to the
microbiome program wind down. Research and development expenses
include non-cash stock-based compensation expenses of $11.4 million
for both of the years ended December 31, 2020 and 2019.
- General and administrative expenses were $7.2
million for the three months ended December 31, 2020 compared to
$10.8 million for the same period in 2019, and $37.1 million for
the year ended December 31, 2020 compared to $32.9 million in 2019.
The increase was primarily due to an increase of $2.7 million of
expenses related to entering into the collaboration agreement with
BeiGene. General and administrative expenses include non-cash
stock-based compensation expenses of $10.5 million for year ended
December 31, 2020 and $9.2 million for the same period in
2019.
- Net loss attributable to common stockholders
was $39.4 million, or $1.10 per basic and diluted share, for the
three months ended December 31, 2020, compared to $27.1 million, or
$1.06 per basic and diluted share, for the same period in 2019. For
the year ended December 31, 2020, net loss was $62.2 million, or
$1.75 per basic and diluted share, compared to $97.6 million, or
$3.72 per basic and diluted share, for the year ended December 31,
2019.
About Assembly BiosciencesAssembly Bio is a
clinical-stage biotechnology company committed to bringing finite
and curative therapies to the 270 million people living with
hepatitis B virus (HBV) worldwide. A pioneer in the development of
a new class of potent, oral core inhibitor drug candidates,
Assembly Bio’s approach aims to break the complex viral replication
cycle of HBV to free patients from a lifetime of therapy. Assembly
Bio’s strategy toward cure includes a leading portfolio of more
potent, next-generation core inhibitors, proof-of-concept
combination studies and a research program focused on the discovery
of novel HBV targets. 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 studies involving its HBV therapeutic product candidates,
including studies contemplated by Assembly Bio’s clinical
collaboration agreements, 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;
continued development and commercialization of Assembly Bio’s HBV
product candidates, if successful, in the China territory will be
dependent on, and subject to, Assembly Bio’s collaboration
agreement governing its activity in the China territory; Assembly
Bio’s ability to maintain financial resources necessary to continue
its clinical studies and fund business operations; any impact that
the COVID-19 pandemic may have on Assembly Bio’s business and
operations, including initiation and continuation of its clinical
studies 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) |
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
|
|
|
ASSETS |
|
|
|
|
Current assets |
|
|
|
|
Cash and cash equivalents |
|
$ |
59,444 |
|
|
$ |
46,732 |
|
Marketable securities |
|
|
156,969 |
|
|
|
227,311 |
|
Accounts receivable from collaboration |
|
|
1,230 |
|
|
|
3,374 |
|
Prepaid expenses and other current assets |
|
|
6,850 |
|
|
|
5,363 |
|
Total current assets |
|
|
224,493 |
|
|
|
282,780 |
|
|
|
|
|
|
Property and equipment, net |
|
|
1,600 |
|
|
|
1,830 |
|
Operating lease right-of-use (ROU) assets |
|
|
9,131 |
|
|
|
11,975 |
|
Other assets |
|
|
6,392 |
|
|
|
1,684 |
|
Indefinite-lived intangible asset |
|
|
29,000 |
|
|
|
29,000 |
|
Goodwill |
|
|
12,638 |
|
|
|
12,638 |
|
Total assets |
|
$ |
283,254 |
|
|
$ |
339,907 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
Current liabilities |
|
|
|
|
Accounts payable |
|
$ |
4,598 |
|
|
$ |
1,731 |
|
Accrued clinical expenses |
|
|
4,444 |
|
|
|
4,826 |
|
Other accrued expenses |
|
|
11,987 |
|
|
|
8,286 |
|
Deferred revenue - short-term |
|
|
— |
|
|
|
6,411 |
|
Operating lease liabilities - short-term |
|
|
3,404 |
|
|
|
3,186 |
|
Total current liabilities |
|
|
24,433 |
|
|
|
24,440 |
|
|
|
|
|
|
Deferred tax liabilities |
|
|
2,531 |
|
|
|
2,531 |
|
Deferred revenue - long-term |
|
|
8,987 |
|
|
|
30,637 |
|
Operating lease liabilities - long-term |
|
|
6,725 |
|
|
|
9,082 |
|
Total liabilities |
|
|
42,676 |
|
|
|
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
December 31, 2020 and 2019; 34,026,680 and 32,558,307 shares
issued and outstanding as of December 31, 2020 and 2019,
respectively |
|
|
34 |
|
|
|
32 |
|
Additional paid-in capital |
|
|
742,387 |
|
|
|
712,807 |
|
Accumulated other comprehensive loss |
|
|
(270 |
) |
|
|
(201 |
) |
Accumulated deficit |
|
|
(501,573 |
) |
|
|
(439,421 |
) |
Total stockholders' equity |
|
|
240,578 |
|
|
|
273,217 |
|
Total liabilities and stockholders' equity |
|
$ |
283,254 |
|
|
$ |
339,907 |
|
|
|
|
|
|
ASSEMBLY BIOSCIENCES, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE INCOME (LOSS) |
(In thousands except for share and per share amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended December 31, |
|
|
|
2020 |
|
|
|
2019 |
|
|
|
2018 |
|
Collaboration revenue |
|
$ |
79,105 |
|
|
$ |
15,963 |
|
|
$ |
14,804 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
Research and development |
|
|
106,823 |
|
|
|
85,757 |
|
|
|
72,741 |
|
General and administrative |
|
|
37,058 |
|
|
|
32,919 |
|
|
|
34,798 |
|
Total operating expenses |
|
|
143,881 |
|
|
|
118,676 |
|
|
|
107,539 |
|
Loss from operations |
|
|
(64,776 |
) |
|
|
(102,713 |
) |
|
|
(92,735 |
) |
|
|
|
|
|
|
|
Other income |
|
|
|
|
|
|
Interest and other income, net |
|
|
2,624 |
|
|
|
4,305 |
|
|
|
3,083 |
|
Total other income |
|
|
2,624 |
|
|
|
4,305 |
|
|
|
3,083 |
|
Loss before income taxes |
|
|
(62,152 |
) |
|
|
(98,408 |
) |
|
|
(89,652 |
) |
|
|
|
|
|
|
|
Income tax benefit |
|
|
— |
|
|
|
774 |
|
|
|
(1,099 |
) |
Net loss |
|
$ |
(62,152 |
) |
|
$ |
(97,634 |
) |
|
$ |
(90,751 |
) |
|
|
|
|
|
|
|
Other comprehensive (loss) income |
|
|
|
|
|
|
Unrealized (loss) gain on marketable securities, net of tax |
|
|
(69 |
) |
|
|
146 |
|
|
|
45 |
|
Comprehensive loss |
|
$ |
(62,221 |
) |
|
$ |
(97,488 |
) |
|
$ |
(90,706 |
) |
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
|
$ |
(1.75 |
) |
|
$ |
(3.72 |
) |
|
$ |
(3.98 |
) |
Weighted average common shares outstanding, basic and diluted |
|
|
35,427,120 |
|
|
|
26,258,790 |
|
|
|
22,801,644 |
|
|
|
|
|
|
|
|
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