Assembly Biosciences Reports Second Quarter 2024 Financial Results and Recent Updates
August 08 2024 - 4:05PM
Assembly Biosciences, Inc. (Nasdaq: ASMB), a biotechnology company
developing innovative therapeutics targeting serious viral
diseases, today reported financial results and recent updates for
the second quarter ended June 30, 2024.
“Entering the second half of the year, I’m incredibly proud of
our team’s accomplishments on our path to delivering novel
therapeutics for individuals living with serious viral diseases,”
said Jason Okazaki, chief executive officer and president of
Assembly Bio. “We are rapidly progressing toward key inflection
points for our clinical development programs and remain on track
with the data sets we plan to deliver in 2024. Specifically, in the
third quarter, we look forward to sharing interim Phase 1a data for
ABI-5366 in healthy participants. The pharmacokinetic data in this
study will enable us to assess ABI-5366's ability to reach the
target concentrations we have established for antiviral efficacy
and to support our once-weekly oral dosing profile, while also
informing dose selection in the Phase 1b part of the study in
participants with recurrent genital herpes.”
Second Quarter 2024 and Recent Highlights
- First participants were dosed in two clinical trials:
- The Phase 1a portion of a Phase 1a/b clinical study of
ABI-5366, a long-acting herpes simplex virus (HSV) helicase-primase
inhibitor candidate; the Phase 1a portion in healthy participants
and the Phase 1b portion to be conducted in participants with
recurrent genital herpes
- A Phase 1b study of ABI-4334, a next-generation, highly potent
capsid assembly modulator candidate, in participants with chronic
hepatitis B virus (HBV) infection
- Scientific conference presentations highlighted:
- Preclinical data for ABI-5366 (poster presentation) and
ABI-1179 (poster and oral presentation) featured at the
International Herpesvirus Workshop held July 13-17, 2024. ABI-1179
is the long-acting HSV helicase-primase inhibitor candidate
contributed by Gilead Sciences, Inc. (Gilead) under the
collaboration between Assembly Bio and Gilead
- Preclinical data for ABI-6250, an oral, small molecule
HBV/hepatitis delta virus (HDV) entry inhibitor candidate, featured
in a poster presentation at the European Association for the Study
of the Liver (EASL) Congress™ 2024 held June 5-8, 2024
- Preclinical data for ABI-6250 featured in an oral presentation
at the Science of HBV Cure Meeting 2024 held July 26-27, 2024
- Strengthened balance sheet with equity investments that
resulted in aggregate gross proceeds to Assembly Bio of
approximately $12.6 million, supporting advancement of antiviral
portfolio and extending cash runway into Q1 2026
Upcoming Anticipated Milestones
- ABI-5366 Phase 1a interim clinical data in healthy participants
expected in Q3 2024 and interim Phase 1b data in participants with
recurrent genital herpes expected in the first half of 2025
- ABI-4334 Phase 1b interim clinical data expected by the end of
2024
- Two additional candidates, ABI-1179 and ABI-6250, are
anticipated to enter the clinic by the end of 2024
Upcoming Conferences
- Abstract highlighting preclinical data for ABI-6250 accepted
for poster presentation at the International HBV Meeting taking
place September 11-15, 2024, in Chicago
Second Quarter 2024 Financial Results
- Cash, cash equivalents and marketable
securities were $109.2 million as of June 30, 2024,
compared to $113.0 million as of March 31, 2024. Assembly Bio’s
cash position is projected to fund operations into Q1 2026.
- Revenue from collaborative research was $8.5
million for the three months ended June 30, 2024. There was no
revenue recognized for the same period in 2023. Revenue for the
three months ended June 30, 2024, consists of amounts recognized
under the collaboration with Gilead.
- Research and development expenses were $16.3
million for the three months ended June 30, 2024, compared to $12.5
million for the same period in 2023. The increase is attributable
to having more candidates in development in 2024.
- General and administrative expenses were $4.5
million for the three months ended June 30, 2024, compared to $5.0
million for the same period in 2023. The decrease is primarily due
to a decrease in non-cash stock-based compensation expense.
- Net loss attributable to common stockholders
was $11.2 million, or $1.98 per basic and diluted share, for the
three months ended June 30, 2024, compared to $16.9 million, or
$3.88 per basic and diluted share, for the same period in
2023.
The investigational products and investigational product
candidates referenced here have not been approved anywhere
globally, and their safety and efficacy have not been
established.
About Assembly BiosciencesAssembly
Biosciences is a biotechnology company dedicated to the development
of innovative small-molecule 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 realize the potential benefits
of its collaboration with Gilead Sciences, Inc., including all
financial aspects of the collaboration and equity investments;
Assembly Bio’s ability to initiate and complete clinical studies
involving its therapeutic product candidates, including studies
contemplated by Assembly Bio’s collaboration with Gilead, in the
currently anticipated timeframes or at all; 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.
Contacts Investor and
Corporate: Shannon Ryan SVP, Investor Relations,
Corporate Affairs and Alliance Management (415)
738-2992 investor_relations@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) |
| |
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2024 |
|
|
2023 |
|
|
|
(Unaudited) |
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
Current assets |
|
|
|
|
|
|
Cash and cash equivalents |
$ |
19,208 |
|
|
$ |
19,841 |
|
|
Marketable securities |
90,011 |
|
|
110,406 |
|
|
Accounts receivable from collaboration |
— |
|
|
43 |
|
|
Prepaid expenses and other current assets |
3,712 |
|
|
3,497 |
|
|
Total current assets |
112,931 |
|
|
133,787 |
|
| |
|
|
|
|
|
|
Property and equipment, net |
349 |
|
|
385 |
|
|
Operating lease right-of-use assets |
1,731 |
|
|
2,339 |
|
|
Other assets |
312 |
|
|
312 |
|
|
Total assets |
$ |
115,323 |
|
|
$ |
136,823 |
|
| |
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS' EQUITY |
|
|
|
|
|
|
Current liabilities |
|
|
|
|
|
|
Accounts payable |
$ |
801 |
|
|
$ |
461 |
|
|
Accrued research and development expenses |
2,531 |
|
|
885 |
|
|
Other accrued expenses |
3,587 |
|
|
5,744 |
|
|
Deferred revenue from a related party - short-term |
33,060 |
|
|
30,915 |
|
|
Operating lease liabilities - short-term |
1,295 |
|
|
1,220 |
|
|
Total current liabilities |
41,274 |
|
|
39,225 |
|
|
|
|
|
|
|
|
|
Deferred revenue from a related party - long-term |
38,916 |
|
|
55,379 |
|
|
Operating lease liabilities - long-term |
451 |
|
|
1,122 |
|
|
Total liabilities |
80,641 |
|
|
95,726 |
|
| |
|
|
|
|
|
|
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
June 30, 2024 and December 31, 2023; 6,345,561 and 5,482,752
shares issued and outstanding as of June 30, 2024 and December
31, 2023, respectively |
6 |
|
|
5 |
|
|
Additional paid-in capital |
840,946 |
|
|
826,921 |
|
|
Accumulated other comprehensive loss |
(293 |
) |
|
(81 |
) |
|
Accumulated deficit |
(805,977 |
) |
|
(785,748 |
) |
|
Total stockholders' equity |
34,682 |
|
|
41,097 |
|
|
Total liabilities and stockholders' equity |
$ |
115,323 |
|
|
$ |
136,823 |
|
|
ASSEMBLY BIOSCIENCES, INC. |
|
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS |
|
(In thousands except for share and per share amounts) |
|
(Unaudited) |
| |
| |
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
| |
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
Collaboration revenue from a related party |
$ |
8,533 |
|
|
$ |
— |
|
|
$ |
14,318 |
|
|
$ |
— |
|
| |
|
|
|
|
|
|
|
|
|
|
|
| Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
16,259 |
|
|
12,523 |
|
|
28,138 |
|
|
27,070 |
|
|
General and administrative |
4,477 |
|
|
4,965 |
|
|
9,112 |
|
|
9,977 |
|
| Total operating expenses |
20,736 |
|
|
17,488 |
|
|
37,250 |
|
|
37,047 |
|
| Loss from
operations |
(12,203 |
) |
|
(17,488 |
) |
|
(22,932 |
) |
|
(37,047 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
| Other
income |
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income, net |
1,457 |
|
|
592 |
|
|
3,109 |
|
|
1,201 |
|
| Total other income |
1,457 |
|
|
592 |
|
|
3,109 |
|
|
1,201 |
|
| Loss before income
taxes |
(10,746 |
) |
|
(16,896 |
) |
|
(19,823 |
) |
|
(35,846 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
| Income tax expense |
406 |
|
|
— |
|
|
406 |
|
|
— |
|
| Net loss |
$ |
(11,152 |
) |
|
$ |
(16,896 |
) |
|
$ |
(20,229 |
) |
|
$ |
(35,846 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
| Other comprehensive
loss |
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized (loss) gain on marketable securities |
(54 |
) |
|
188 |
|
|
(212 |
) |
|
478 |
|
| Comprehensive
loss |
$ |
(11,206 |
) |
|
$ |
(16,708 |
) |
|
$ |
(20,441 |
) |
|
$ |
(35,368 |
) |
| |
|
|
|
|
|
|
|
|
|
|
|
| Net loss per share, basic and
diluted |
$ |
(1.98 |
) |
|
$ |
(3.88 |
) |
|
$ |
(3.64 |
) |
|
$ |
(8.33 |
) |
| Weighted average common shares
outstanding, basic and diluted |
5,642,752 |
|
|
4,355,007 |
|
|
5,563,033 |
|
|
4,303,244 |
|
| |
|
|
|
|
|
|
|
|
|
|
|
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