Assembly Biosciences Reports First Quarter 2023 Financial Results and Recent Highlights
04 Maio 2023 - 5:05PM
Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company
developing innovative antiviral therapeutics targeting serious
viral diseases, today reported financial results and recent
highlights for the first quarter ended March 31, 2023.
“Thanks to the depth and breadth of our team’s virology drug
development expertise, we were thrilled to nominate the first
development candidate from our expanded virology pipeline, 5366,
during the first quarter,” said Jason Okazaki, chief executive
officer and president of Assembly Bio. “With 5366 targeting
high-recurrence genital herpes expected to enter the clinic in the
first half of 2024 and nomination of a second pipeline candidate
anticipated later this year, we look forward to advancing these new
programs that are designed to address significant unmet medical
needs with the potential for shorter paths to reaching key
inflection points and clinical proof of concept.”
“With respect to our core inhibitors, we reported promising
additional clinical data for 4334 and made the strategic decision
to evaluate partnering options for our core inhibitor portfolio,”
continued Mr. Okazaki. “We believe partnering the core inhibitors
will enable opportunities for further clinical development aimed at
achieving a functional cure for HBV, including through combination
approaches. It also allows our teams to focus on accelerating 5366
and other compounds in our expanded virology portfolio, which offer
us greater potential to have a near-term impact for patients and
stockholders.”
First Quarter 2023 and Recent Highlights
- Announced nomination of Assembly Bio’s first herpesvirus
development candidate, ABI-5366 (5366), a long-acting helicase
inhibitor targeting high-recurrence genital herpes, for advancement
to IND-enabling studies
- Reported data updates for two next-generation hepatitis B virus
(HBV) core inhibitor candidates including Phase 1b data for
ABI-H3733 (3733) in patients with chronic HBV infection and Phase
1a data of ABI-4334 (4334) in healthy subjects
- Announced the company’s intention to prioritize resources on
Assembly Bio’s promising portfolio of antiviral programs with
shorter paths to clinical proof of concept, including 5366, and
evaluate partnering options for its core inhibitor portfolio prior
to further clinical development of the mechanism for HBV cure
Anticipated Milestones and Events
- Nominate one additional development candidate from the expanded
research portfolio in 2023
- Complete IND/CTA submission for 5366 and enter the clinic in
the first half of 2024
- Advance one additional development candidate from a second
program into clinical development by year end 2024
Upcoming Conferences
- Multiple abstracts accepted for presentation during the
European Association for the Study of the Liver (EASL)
International Liver CongressTM, June 21-24, 2023, highlighting
preclinical data for the company’s oral, small molecule
HBV/hepatitis delta virus (HDV) viral entry inhibitor program as
well as results from 3733 and 4334 clinical and in vitro
studies
- Presentation by Mr. Okazaki and William Delaney, PhD, chief
scientific officer of Assembly Bio, during the Jefferies Healthcare
Conference, June 7-9, 2023
- Presentation during the Science of HBV Cure meeting held June
2-3, 2023, on next-generation core inhibitors
- Submitting data on preclinical characterization of 5366 for
scientific presentation during 2H 2023
First Quarter 2023 Financial Results
- Cash, cash equivalents and marketable
securities were $73.0 million as of March 31, 2023,
compared to $91.6 million as of December 31, 2022. Assembly Bio’s
cash position is projected to fund operations into the third
quarter of 2024.
- Research and development expenses were $14.5
million for the three months ended March 31, 2023, compared to
$17.2 million for the same period in 2022. The decrease is
primarily due to the discontinued development of vebicorvir and
ABI-H2158 as well as decreases in employee and contractor-related
expenses.
- General and administrative expenses were $5.0
million for the three months ended March 31, 2023, compared to $6.0
million for the same period in 2022. The decrease is primarily due
to overall cost-saving initiatives.
- Net loss attributable to common stockholders
was $19.0 million, or $0.37 per basic and diluted share, for the
three months ended March 31, 2023, compared to $23.1 million, or
$0.48 per basic and diluted share, for the same period in
2022.
About Assembly BiosciencesAssembly
Biosciences is a biotechnology company dedicated to the development
of innovative small molecule antiviral therapeutics designed to
change the path of serious viral diseases and improve the lives of
patients worldwide. Led by an accomplished team of leaders in
virologic drug development, Assembly Bio is committed to improving
outcomes for patients struggling with the serious, chronic impacts
of herpesvirus, hepatitis B virus (HBV) and hepatitis delta virus
(HDV) infections. 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 maintain financial resources
necessary to continue its clinical studies and fund business
operations; 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 or nonclinical 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; 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 Ryan SVP, Investor Relations,
Corporate Affairs and Alliance Management (415)
738-2992 sryan@assemblybio.com
Media: Sam Brown Inc.Hannah Hurdle(805)
338-4752ASMBMedia@sambrown.com
|
ASSEMBLY
BIOSCIENCES, INC. |
CONDENSED
CONSOLIDATED BALANCE SHEETS |
(In thousands except
for share amounts and par value) |
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
|
2023 |
|
2022 |
|
|
(Unaudited) |
|
|
ASSETS |
|
|
|
|
Current assets |
|
|
|
|
Cash and cash equivalents |
|
$ |
43,482 |
|
|
$ |
52,418 |
|
Marketable securities |
|
|
29,534 |
|
|
|
39,192 |
|
Accounts receivable from collaboration |
|
|
717 |
|
|
|
944 |
|
Prepaid expenses and other current assets |
|
|
6,011 |
|
|
|
4,413 |
|
Total current assets |
|
|
79,744 |
|
|
|
96,967 |
|
|
|
|
|
|
Property and equipment, net |
|
|
619 |
|
|
|
743 |
|
Operating lease right-of-use (ROU) assets |
|
|
2,419 |
|
|
|
3,195 |
|
Other assets |
|
|
334 |
|
|
|
889 |
|
Total assets |
|
$ |
83,116 |
|
|
$ |
101,794 |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
Current liabilities |
|
|
|
|
Accounts payable |
|
$ |
1,224 |
|
|
$ |
2,493 |
|
Accrued research and development expenses |
|
|
3,046 |
|
|
|
3,122 |
|
Other accrued expenses |
|
|
3,154 |
|
|
|
7,317 |
|
Operating lease liabilities - short-term |
|
|
2,546 |
|
|
|
3,364 |
|
Total current liabilities |
|
|
9,970 |
|
|
|
16,296 |
|
|
|
|
|
|
Deferred revenue |
|
|
2,733 |
|
|
|
2,733 |
|
Operating lease liabilities - long-term |
|
|
80 |
|
|
|
101 |
|
Total liabilities |
|
|
12,783 |
|
|
|
19,130 |
|
|
|
|
|
|
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 shares authorized as of
March 31, 2023 and December 31, 2022; 52,015,268 and
48,894,973 shares issued and outstanding as of March 31, 2023
and December 31, 2022, respectively |
|
|
52 |
|
|
|
49 |
|
Additional paid-in capital |
|
|
814,264 |
|
|
|
807,938 |
|
Accumulated other comprehensive loss |
|
|
(513 |
) |
|
|
(803 |
) |
Accumulated deficit |
|
|
(743,470 |
) |
|
|
(724,560 |
) |
Total stockholders' equity |
|
|
70,333 |
|
|
|
82,624 |
|
Total liabilities and stockholders' equity |
|
$ |
83,116 |
|
|
$ |
101,794 |
|
|
|
|
|
|
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, |
|
|
2023 |
|
2022 |
Operating expenses |
|
|
|
|
Research and development |
|
$ |
14,547 |
|
|
$ |
17,205 |
|
General and administrative |
|
|
5,012 |
|
|
|
5,957 |
|
Total operating expenses |
|
|
19,559 |
|
|
|
23,162 |
|
Loss from operations |
|
|
(19,559 |
) |
|
|
(23,162 |
) |
|
|
|
|
|
Other income |
|
|
|
|
Interest and other income, net |
|
|
609 |
|
|
|
71 |
|
Total other income |
|
|
609 |
|
|
|
71 |
|
Net loss |
|
$ |
(18,950 |
) |
|
$ |
(23,091 |
) |
|
|
|
|
|
Other comprehensive loss |
|
|
|
|
Unrealized gain (loss) on marketable securities |
|
|
290 |
|
|
|
(489 |
) |
Comprehensive loss |
|
$ |
(18,660 |
) |
|
$ |
(23,580 |
) |
|
|
|
|
|
Net loss per share, basic and diluted |
|
$ |
(0.37 |
) |
|
$ |
(0.48 |
) |
Weighted average common shares outstanding, basic and diluted |
|
|
51,012,450 |
|
|
|
48,123,930 |
|
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