Assembly Biosciences Reports Third Quarter 2022 Financial Results and Recent Highlights and Announces Upcoming Conference Participation
09 November 2022 - 8:05AM
Assembly Biosciences, Inc. (Nasdaq: ASMB), a clinical-stage
biotechnology company developing innovative, investigational
therapeutics targeting hepatitis B virus (HBV) and other viral
diseases, today announced financial results and recent highlights
for the third quarter ended September 30, 2022.
“During the third quarter, we have advanced clinical development
of both of our next-generation, more potent core inhibitors with
the Phase 1b study of 3733 on track to report initial data by the
end of this year and the initiation of the first clinical study for
4334,” said John McHutchison, AO, MD, chief executive officer of
Assembly Bio. “This quarter also marked the further expansion of
our pipeline with the introduction of our first research programs
outside of HBV and hepatitis delta virus. These programs, targeting
high-recurrence genital herpes and transplant-associated
herpesviruses, apply the deep expertise of our organization in
small molecule antiviral drug development to develop differentiated
approaches for viral diseases with significant unmet medical need.
We are thrilled with the progress of our preclinical and clinical
programs, and we remain encouraged about the potential for our
next-generation core inhibitors with the recently presented data at
AASLD and upcoming clinical data readout for 3733.”
Recent Updates
- Received CTA clearance and initiated a blinded,
placebo-controlled Phase 1a trial in New Zealand of the company’s
next-generation investigational core inhibitor, ABI-4334 (4334),
evaluating safety, tolerability and pharmacokinetics of single and
multiple ascending doses of 4334 in healthy subjects.
- Introduced the first two new research programs expanding
Assembly Bio’s portfolio beyond HBV and hepatitis delta virus
(HDV):
- A long-acting herpes simplex virus type 2 (HSV-2) helicase
inhibitor to treat high-recurrence genital herpes, and
- A pan-herpes non-nucleoside polymerase inhibitor to treat
multiple transplant-associated herpesvirus infections.
- Announced the retirement of John McHutchison as chief executive
officer (CEO) effective at the end of 2022 and the election of
Jason Okazaki, currently president and chief operating officer, to
succeed Dr. McHutchison as CEO and president and a member of the
board of directors. Dr. McHutchison will continue to serve on the
board of directors and assume the role of chair of the Science and
Technology Committee.
- Presented four posters at the American Association for the
Study of Liver Diseases (AASLD) The Liver Meeting®, held November
4-8, 2022, including results from Assembly Bio’s next-generation
core inhibitor 4334 and the first presentations of data from the
company’s HBV/HDV entry inhibitor and interferon-α receptor (IFNAR)
agonist research programs:
- ABI-4334, a novel hepatitis B virus core inhibitor, accelerates
capsid assembly and inhibits cccDNA formation via multiple
pathways
- Preclinical characterization of a novel class of highly potent
small molecule hepatitis B and D virus entry inhibitors
- Preclinical characterization of a novel liver-focused small
molecule efficiently inhibiting hepatitis B virus by activating
type I interferon signaling
- Evaluation of the vebicorvir, NrtI, and AB-729 combination in
virologically suppressed patients with HBeAg negative chronic
hepatitis B virus infection: Interim analysis from an open label
Phase 2 study
- Additional Conference Participation:
- Presented at the International Workshop on HBV Cure 2022 held
November 2, 2022, on “Next generation core inhibitors (capsid
assembly modulators).”
- Presented at the 2022 International HBV Meeting held September
18-20, 2022, on “Next generation core inhibitors demonstrate
increased potency and distinct biochemical properties compared to
first-generation core inhibitors.”
- Presented at Discovery on Target 2022 held October 17-20, 2022,
on “HBV core inhibitors for the treatment of chronic viral
infection.”
- Mr. Okazaki and William Delaney, PhD, chief scientific officer,
presented during the H.C. Wainwright 3rd Annual HBV Virtual
Conference held October 18, 2022.
- Dr. McHutchison presented during the H.C. Wainwright 24th
Annual Global Investment Conference held September 12-14,
2022.
Anticipated Milestones and Events
- Initial Phase 1b data for ABI-H3733 (3733) in 2H 2022.
- Full Phase 1b data for 3733 in 1H 2023.
- Full Phase 1a data for 4334 in 1H 2023.
- Two development candidate nominations from Assembly Bio’s
expanded research portfolio in 2023.
Upcoming Conferences
- Mr. Okazaki and Dr. Delaney will present in a fireside chat
during the Jefferies London Healthcare Conference at 5:35 p.m. GMT
on November 15, 2022. A live webcast will be available on the
Events and Presentations section of Assembly Bio’s website and a
replay will be accessible following the event. To register for the
live webcast and replay, please visit:
https://investor.assemblybio.com/events-presentations.
Third Quarter 2022 Financial Results
- Cash, cash equivalents and marketable
securities were $108.7 million as of September 30,
2022, compared to $128.6 million as of June 30, 2022. The company’s
cash position is projected to fund operations into the first half
of 2024.
- Research and development expenses were
$18.1 million for the three months ended September 30, 2022,
compared to $18.5 million for the same period in 2021. The decrease
is primarily due to the discontinued development of ABI-H2158 and
VBR, partially offset by increases in our 3733, 4334, and research
and discovery programs.
- General and administrative expenses were
$5.3 million for the three months ended September 30, 2022,
compared to $6.7 million for the same period in 2021. The decrease
is primarily due to a decrease in professional fees.
- Net loss attributable to common
stockholders was $23.1 million, or $0.48 per basic
and diluted share, for the three months ended September 30, 2022,
compared to $18.8 million, or $0.41 per basic and diluted share,
for the same period in 2021.
About Assembly BiosciencesAssembly Bio is
a clinical-stage biotechnology company pioneering the development
of novel therapeutics for serious viral diseases. Assembly Bio is
advancing a leading portfolio of more potent, next-generation core
inhibitor drug candidates that aim to break the complex viral
replication cycle of hepatitis B virus (HBV) to achieve finite and
potentially curative therapies for the 296 million people living
with HBV worldwide. The company’s research pipeline includes
differentiated antiviral approaches against HBV/hepatitis delta
virus and herpesviruses. 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 successfully execute its
previously announced reprioritization and restructuring activities,
including the CEO transition; potential adverse legal,
reputational, operational and financial effects on Assembly Bio
resulting from the reprioritization and restructuring activities;
Assembly Bio’s ability to initiate and complete clinical studies
involving its therapeutic product candidates, including studies
contemplated by Assembly Bio’s 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; results of nonclinical
studies may not be representative of disease behavior in a clinical
setting and may not be predictive of the outcomes of clinical
studies; continued development and commercialization of ABI-H3733,
if successful, in the China territory will be dependent on, and
subject to, Assembly Bio’s collaboration agreement governing this
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, enrollment 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:Shannon RyanSVP, Investor Relations, Corporate
Affairs and Alliance Management(415)
738-2992sryan@assemblybio.com
Media:Sam Brown Inc. Hannah
Hurdle (805) 338-4752 ASMBMedia@sambrown.com
|
ASSEMBLY
BIOSCIENCES, INC. |
CONDENSED
CONSOLIDATED BALANCE SHEETS |
(In thousands except
for share amounts and par value) |
|
|
|
|
|
September
30, |
|
December 31, |
|
|
2022 |
|
|
|
2021 |
|
|
(Unaudited) |
|
|
ASSETS |
|
|
|
Current
assets |
|
|
|
Cash and cash equivalents |
$ |
54,673 |
|
|
$ |
45,627 |
|
Marketable securities - short-term |
|
53,978 |
|
|
|
101,000 |
|
Accounts receivable from collaborations |
|
1,246 |
|
|
|
336 |
|
Prepaid expenses and other current assets |
|
5,181 |
|
|
|
7,241 |
|
Total
current assets |
|
115,078 |
|
|
|
154,204 |
|
|
|
|
|
Marketable securities - long-term |
|
— |
|
|
|
27,972 |
|
Property and equipment, net |
|
867 |
|
|
|
1,139 |
|
Operating lease right-of-use (ROU) assets |
|
3,958 |
|
|
|
6,042 |
|
Other assets |
|
1,613 |
|
|
|
1,703 |
|
Total assets |
$ |
121,516 |
|
|
$ |
191,060 |
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
Current
liabilities |
|
|
|
Accounts payable |
$ |
1,942 |
|
|
$ |
2,659 |
|
Accrued research and development expenses |
|
4,462 |
|
|
|
3,400 |
|
Other accrued expenses |
|
5,686 |
|
|
|
6,863 |
|
Operating lease liabilities - short-term |
|
3,371 |
|
|
|
3,151 |
|
Total
current liabilities |
|
15,461 |
|
|
|
16,073 |
|
|
|
|
|
Deferred revenue |
|
2,733 |
|
|
|
2,733 |
|
Operating lease liabilities - long-term |
|
918 |
|
|
|
3,325 |
|
Total liabilities |
|
19,112 |
|
|
|
22,131 |
|
|
|
|
|
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; 150,000,000 and 100,000,000 shares
authorized as of September 30, 2022 and December 31, 2021,
respectively; 48,481,194 and 48,120,437 shares issued and
outstanding as of September 30, 2022 and December 31, 2021,
respectively |
|
48 |
|
|
|
48 |
|
Additional paid-in capital |
|
805,480 |
|
|
|
800,728 |
|
Accumulated other comprehensive loss |
|
(999 |
) |
|
|
(419 |
) |
Accumulated deficit |
|
(702,125 |
) |
|
|
(631,428 |
) |
Total stockholders' equity |
|
102,404 |
|
|
|
168,929 |
|
Total liabilities and stockholders' equity |
$ |
121,516 |
|
|
$ |
191,060 |
|
|
|
|
|
ASSEMBLY
BIOSCIENCES, INC. |
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS |
(In thousands except
for share and per share amounts) |
(Unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Collaboration revenue |
$ |
— |
|
|
$ |
6,254 |
|
|
$ |
— |
|
|
$ |
6,254 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
18,130 |
|
|
|
18,474 |
|
|
|
53,127 |
|
|
|
53,777 |
|
General and administrative |
|
5,271 |
|
|
|
6,655 |
|
|
|
18,009 |
|
|
|
22,276 |
|
Total
operating expenses |
|
23,401 |
|
|
|
25,129 |
|
|
|
71,136 |
|
|
|
76,053 |
|
Loss
from operations |
|
(23,401 |
) |
|
|
(18,875 |
) |
|
|
(71,136 |
) |
|
|
(69,799 |
) |
|
|
|
|
|
|
|
|
Other income: |
|
|
|
|
|
|
|
Interest and other income, net |
|
256 |
|
|
|
72 |
|
|
|
439 |
|
|
|
201 |
|
Total other
income |
|
256 |
|
|
|
72 |
|
|
|
439 |
|
|
|
201 |
|
Net
loss |
$ |
(23,145 |
) |
|
$ |
(18,803 |
) |
|
$ |
(70,697 |
) |
|
$ |
(69,598 |
) |
|
|
|
|
|
|
|
|
Other comprehensive loss |
|
|
|
|
|
|
|
Unrealized loss on marketable securities |
|
(1 |
) |
|
|
(15 |
) |
|
|
(580 |
) |
|
|
(18 |
) |
Comprehensive loss |
$ |
(23,146 |
) |
|
$ |
(18,818 |
) |
|
$ |
(71,277 |
) |
|
$ |
(69,616 |
) |
|
|
|
|
|
|
|
|
Net loss per
share, basic and diluted |
$ |
(0.48 |
) |
|
$ |
(0.41 |
) |
|
$ |
(1.46 |
) |
|
$ |
(1.63 |
) |
Weighted
average common shares outstanding, basic and diluted |
|
48,448,399 |
|
|
|
45,569,276 |
|
|
|
48,289,501 |
|
|
|
42,725,109 |
|
|
|
|
|
|
|
|
|
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