Assembly Biosciences Reports First Quarter 2021 Financial Results and Recent Updates
May 06 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 updates for the first quarter ended March 31, 2021.
“In the first quarter of 2021, we solidified all our efforts and
focus on hepatitis B and the sole pursuit of finite and curative
therapies to replace burdensome life-long treatment regimens for
the more than 250 million people living with this disease,” said
John McHutchison, AO, MD, Chief Executive Officer and President of
Assembly Bio. “Our strategy is clear and we have made significant
progress, continuing to advance all our clinical programs while
expanding and accelerating our novel discovery efforts. We are
particularly excited that our first Phase 2 proof-of-concept triple
combination studies – key drivers of our clinical strategy – are
now underway.”
Recent Updates
- Initiated two triple combination studies:
- Phase 2 study evaluating Assembly Bio’s lead core inhibitor
candidate, vebicorvir (VBR), with standard-of-care nucleos(t)ide
reverse transcriptase inhibitor (Nrtl) therapy and Arbutus
Biopharma’s RNAi therapeutic candidate, AB-729
- Phase 2 study evaluating VBR with NrtI therapy and interferon
(peg-IFNα)
Anticipated Milestones and Events
- Nominate a fourth core inhibitor candidate with a best-in-class
profile in Q2 2021
- Interim data from Phase 2 study with ABI-H2158 in H2 2021
Upcoming Conferences
- Chief Scientific Officer, William Delaney, PhD, to present at
the Chronic Hepatitis B Drug Development Virtual Summit, May 6,
2021, during a session on “Targeting HBV Core Protein to Improve
Treatment for cHBV patients.”
- Jefferies Global Healthcare Conference: June 1-3, 2021
- The International Liver Congress™(ILC), the Annual Meeting of
the European Association for the Study of the Liver (EASL) taking
place virtually June 23-26, 2021 Assembly Bio has three abstracts
accepted for presentation:
- Enhanced potency and target coverage for both antiviral
inhibition and cccDNA establishment of next generation core
inhibitors ABI-H2158 and ABI-H3733
- Viral response and safety following treatment discontinuation
in Study 211, the open-label extension study of VBR in combination
with NrtI therapy
- No emergent core inhibitor resistance in patients with chronic
HBV infection treated with VBR in combination with NrtI
First Quarter 2021 Financial Results
- Cash, cash equivalents and marketable
securities were $214.9 million as of March 31, 2021,
compared to $216.4 million as of December 31, 2020. This result
includes $34.1 million of net proceeds from the issuance of common
shares under Assembly Bio’s at-the-market (ATM) program. The
company’s cash position is projected to fund operations into
2023.
- Revenues from collaborative research were $0
for the three months ended March 31, 2021, compared to $4.1 million
for the same period in 2020. The decrease is due to the termination
of the microbiome collaboration agreement with Allergan
Pharmaceuticals following AbbVie Inc’s acquisition of Allergan. In
Q1 2021 Assembly Bio completed the previously announced winddown of
its microbiome program.
- Research and development expenses were $18.6
million for the three months ended March 31, 2021, compared to
$23.0 million for the same period in 2020. The decrease is
primarily due to a decrease of $8.2 million related to the
wind-down of Assembly Bio’s microbiome program. This decrease was
partially offset by an increase of $3.7 million in research and
development expenses related to the company’s HBV program. Research
and development expenses include non-cash stock-based compensation
expenses of $(2.1) million for the three months ended March 31,
2021 and $1.9 million for the same period in 2020. The decrease is
primarily due to the reversal of $2.4 million of previously
recognized stock-based compensation expense related to forfeited
awards of former microbiome program employees.
- General and administrative expenses were $8.7
million for both the three months ended March 31, 2021 and 2020.
General and administrative expenses include non-cash stock-based
compensation expenses of $1.8 million for the three months ended
March 31, 2021 and $3.0 million for the same period in 2020.
- Net loss attributable to common stockholders
was $27.2 million, or $0.69 per basic and diluted share, for the
three months ended March 31, 2021, compared to $26.7 million, or
$0.76 per basic and diluted share, for the same period in
2020.
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 StatementsThe 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 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
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) |
|
|
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
(Unaudited) |
|
|
|
ASSETS |
|
|
|
|
|
Current
assets |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
78,253 |
|
|
$ |
59,444 |
|
|
Marketable securities |
|
|
136,631 |
|
|
|
156,969 |
|
|
Accounts receivable from collaborations |
|
|
203 |
|
|
|
1,230 |
|
|
Prepaid expenses and other current assets |
|
|
6,547 |
|
|
|
6,850 |
|
|
Total
current assets |
|
|
221,634 |
|
|
|
224,493 |
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
1,493 |
|
|
|
1,600 |
|
|
Operating lease right-of-use (ROU) assets |
|
|
8,104 |
|
|
|
9,131 |
|
|
Other assets |
|
|
6,034 |
|
|
|
6,392 |
|
|
Indefinite-lived intangible asset |
|
|
29,000 |
|
|
|
29,000 |
|
|
Goodwill |
|
|
12,638 |
|
|
|
12,638 |
|
|
Total assets |
|
$ |
278,903 |
|
|
$ |
283,254 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
Accounts payable |
|
$ |
3,562 |
|
|
$ |
4,598 |
|
|
Accrued clinical expenses |
|
|
4,342 |
|
|
|
4,444 |
|
|
Other accrued expenses |
|
|
3,659 |
|
|
|
11,987 |
|
|
Operating lease liabilities - short-term |
|
|
2,934 |
|
|
|
3,404 |
|
|
Total
current liabilities |
|
|
14,497 |
|
|
|
24,433 |
|
|
|
|
|
|
|
|
Deferred tax liabilities |
|
|
2,531 |
|
|
|
2,531 |
|
|
Deferred revenue |
|
|
8,987 |
|
|
|
8,987 |
|
|
Operating lease liabilities - long-term |
|
|
5,644 |
|
|
|
6,725 |
|
|
Total liabilities |
|
|
31,659 |
|
|
|
42,676 |
|
|
|
|
|
|
|
|
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, 2021 and December 31, 2020; 40,104,684 and
34,026,680 shares issued and outstanding as of March 31, 2021
and December 31, 2020, respectively |
|
|
40 |
|
|
|
34 |
|
|
Additional paid-in capital |
|
|
776,248 |
|
|
|
742,387 |
|
|
Accumulated other comprehensive loss |
|
|
(271 |
) |
|
|
(270 |
) |
|
Accumulated deficit |
|
|
(528,773 |
) |
|
|
(501,573 |
) |
|
Total stockholders' equity |
|
|
247,244 |
|
|
|
240,578 |
|
|
Total liabilities and stockholders' equity |
|
$ |
278,903 |
|
|
$ |
283,254 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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, |
|
|
|
|
2021 |
|
|
|
2020 |
|
|
Collaboration revenue |
|
$ |
— |
|
|
$ |
4,081 |
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
Research and development |
|
|
18,554 |
|
|
|
23,046 |
|
|
General and administrative |
|
|
8,704 |
|
|
|
8,729 |
|
|
Total
operating expenses |
|
|
27,258 |
|
|
|
31,775 |
|
|
Loss
from operations |
|
|
(27,258 |
) |
|
|
(27,694 |
) |
|
|
|
|
|
|
|
Other income: |
|
|
|
|
|
Interest and other income, net |
|
|
58 |
|
|
|
1,039 |
|
|
Total other
income |
|
|
58 |
|
|
|
1,039 |
|
|
Net
loss |
|
$ |
(27,200 |
) |
|
$ |
(26,655 |
) |
|
|
|
|
|
|
|
Other
comprehensive (loss) income |
|
|
|
|
|
Unrealized (loss) gain on marketable securities |
|
|
(1 |
) |
|
|
115 |
|
|
Comprehensive loss |
|
$ |
(27,201 |
) |
|
$ |
(26,540 |
) |
|
|
|
|
|
|
|
Net loss per
share, basic and diluted |
|
$ |
(0.69 |
) |
|
$ |
(0.76 |
) |
|
Weighted
average common shares outstanding, basic and diluted |
|
|
39,679,734 |
|
|
|
35,079,756 |
|
|
|
|
|
|
|
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