On this page of StockholderLetter.com we present the latest annual shareholder letter from ASSEMBLY BIOSCIENCES, INC. — ticker symbol ASMB. Reading current and past ASMB letters to shareholders can bring important insights into the investment thesis.
2025 Annual Report
To Our Stockholders, 2025 was a year of extraordinary progress for Assembly Bio, marked by positive data readouts across our broad antiviral pipeline, in some cases far exceeding our targets. We continue to focus on disciplined execution and data-driven clinical development, taking decisive steps that position us to achieve signi cant additional milestones across multiple programs. We enter 2026 with strong momentum propelled by four key developments: compelling proof-of-concept data for ABI-5366 and ABI-1179, two herpes simplex virus (HSV) helicase-primase inhibitor (HPI) candidates for recurrent genital herpes (RGH); encouraging Phase 1a data for ABI-6250, our oral small molecule hepatitis delta virus (HDV) entry inhibitor candidate; completion of $175 million in new equity nancings; and the decision by our partner, Gilead Sciences, Inc. (Gilead), to exercise its option to license the HPI program. Together, these accomplishments underscore the promise of our antiviral pipeline, innovation of our discovery engine and strength of our strategy. Advancing Long-Acting HPI Programs in Recurrent Genital Herpes This year, we achieved an important milestone with positive interim results from our Phase 1b studies evaluating HPI candidates, ABI-5366 and ABI-1179, in participants with RGH. These studies brought forward clear evidence of encouraging antiviral activity for both assets, demonstrating unprecedented reductions in viral shedding and virologically con rmed lesions paired with strong safety and pharmacokinetic pro les. For ABI-5366, the interim data represented the program s rst Phase 1b results, while the Phase 1b study of ABI-1179 continued to reinforce the potential of long-acting helicase primase inhibition as a differentiated approach to chronic suppressive therapy of RGH. Both sets of results outperformed our expectations for antiviral ef cacy and clinical outcomes, and provided a clear rationale for advancement into Phase 2 clinical evaluation. These ndings re ect the signi cant potential of the HSV program and the dedication of our team in driving two promising candidates toward their next stages of development. Gilead Exercises Its Option to License ABI-5366 and ABI-1179 As a result of the favorable data observed in the Phase 1b studies, Gilead exercised its option to exclusively license our HPI program for the treatment of recurrent genital herpes, which includes both ABI-5366 and ABI-1179, for a net $35 million option fee. This milestone marks the rst
option exercised through our R&D collaboration with Gilead and underscores the potential of our antiviral pipeline and the productivity of our collaboration. Gilead s decision reinforces our shared commitment to delivering novel antiviral medicines for a disease area that has seen no new approved therapies in more than 25 years. Gilead will advance the HPI program under its global development and commercialization leadership, sustained by a foundation grounded in scienti c alignment and the pursuit of meaningful innovation in virology. We have the right to opt in to share 40% of U.S. costs and pro ts in lieu of receiving U.S. milestones and royalties. We anticipate receiving Gilead s development plan and making this decision by mid-2026. Clinical Progress in HDV: ABI-6250 Phase 1a Interim Data We also reported positive Phase 1a interim data from the rst clinical study evaluating ABI6250, our oral HDV entry inhibitor candidate. The results highlighted ABI-6250 s promising pharmacologic and safety pro le, as well as its potential for daily oral dosing. We are excited about the potential of ABI-6250 as an oral therapy for chronic HDV, and we look forward to initiating a Phase 2 study by the end of 2026. Strengthening Our Financial Position Through a $175 Million Equity Financing in our pipeline, exercise collaboration rights where appropriate and continue building a differentiated antiviral discovery engine. Looking Ahead In 2026, Assembly Bio will continue advancing our current programs with the same scienti c rigor and operational discipline that have de ned our progress to date. Along with our ongoing clinical programs, we expect to see further progress in our new compound discovery efforts. We are also evaluating partnering opportunities to support the continued development of ABI4334, our highly potent next-generation capsid assembly modulator designed to disrupt the replication cycle of hepatitis B virus. With Gilead exercising the option to license our HPI program, ongoing innovation emanating from our discovery engine, a strong cash runway and encouraging clinical signals across multiple modalities, we believe Assembly Bio is well positioned for the next stages of value creation. I want to extend my gratitude to our team, whose dedication and expertise drive every milestone we achieve, and to our stockholders, whose support enables us to pursue innovation with purpose and urgency. We look forward to another year of clinical progress as we work to bring meaningful antiviral therapies to the patients who need them most. In August, we announced the pricing of $175 million in equity nancings, comprising an underwritten public offering and concurrent private placement with Gilead. These transactions included participation from a distinguished group of new and existing healthcare-focused institutional investors. Sincerely, This capital raise enhances our balance sheet and positions Assembly Bio to invest con dently Jason A. Okazaki Chief Executive Of cer and President
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 • Benford's Law Stocks icon ASMB Benford's Law Stock Score = 56


ASMB Shareholder/Stockholder Letter Transcript:

2025 Annual Report

To Our Stockholders,
2025 was a year of extraordinary progress for
Assembly Bio, marked by positive data readouts
across our broad antiviral pipeline, in some cases
far exceeding our targets. We continue to focus
on disciplined execution and data-driven clinical
development, taking decisive steps that position
us to achieve signi   cant additional milestones
across multiple programs.
We enter 2026 with strong momentum
propelled by four key developments: compelling
proof-of-concept data for ABI-5366 and ABI-1179,
two herpes simplex virus (HSV) helicase-primase
inhibitor (HPI) candidates for recurrent genital
herpes (RGH); encouraging Phase 1a data for
ABI-6250, our oral small molecule hepatitis delta
virus (HDV) entry inhibitor candidate; completion
of $175 million in new equity    nancings; and the
decision by our partner, Gilead Sciences, Inc.
(Gilead), to exercise its option to license the HPI
program. Together, these accomplishments
underscore the promise of our antiviral pipeline,
innovation of our discovery engine and strength
of our strategy.
Advancing Long-Acting HPI Programs in
Recurrent Genital Herpes
This year, we achieved an important milestone
with positive interim results from our Phase 1b
studies evaluating HPI candidates, ABI-5366 and
ABI-1179, in participants with RGH. These studies
brought forward clear evidence of encouraging
antiviral activity for both assets, demonstrating
unprecedented reductions in viral shedding and
virologically con   rmed lesions paired with strong
safety and pharmacokinetic pro   les.
For ABI-5366, the interim data represented
the program   s    rst Phase 1b results, while the
Phase 1b study of ABI-1179 continued to reinforce
the potential of long-acting helicase primase
inhibition as a differentiated approach to chronic
suppressive therapy of RGH. Both sets of results
outperformed our expectations for antiviral
ef   cacy and clinical outcomes, and provided a
clear rationale for advancement into Phase 2
clinical evaluation.
These    ndings re   ect the signi   cant potential of
the HSV program and the dedication of our team
in driving two promising candidates toward their
next stages of development.
Gilead Exercises Its Option to License
ABI-5366 and ABI-1179
As a result of the favorable data observed in the
Phase 1b studies, Gilead exercised its option
to exclusively license our HPI program for the
treatment of recurrent genital herpes, which
includes both ABI-5366 and ABI-1179, for a net $35
million option fee. This milestone marks the    rst

option exercised through our R&D collaboration
with Gilead and underscores the potential of
our antiviral pipeline and the productivity of our
collaboration. Gilead   s decision reinforces our
shared commitment to delivering novel antiviral
medicines for a disease area that has seen no
new approved therapies in more than 25 years.
Gilead will advance the HPI program under its
global development and commercialization
leadership, sustained by a foundation grounded in
scienti   c alignment and the pursuit of meaningful
innovation in virology. We have the right to opt
in to share 40% of U.S. costs and pro   ts in lieu
of receiving U.S. milestones and royalties. We
anticipate receiving Gilead   s development plan
and making this decision by mid-2026.
Clinical Progress in HDV: ABI-6250 Phase 1a
Interim Data
We also reported positive Phase 1a interim data
from the    rst clinical study evaluating ABI6250, our oral HDV entry inhibitor candidate.
The results highlighted ABI-6250   s promising
pharmacologic and safety pro   le, as well as its
potential for daily oral dosing. We are excited
about the potential of ABI-6250 as an oral
therapy for chronic HDV, and we look forward to
initiating a Phase 2 study by the end of 2026.
Strengthening Our Financial Position
Through a $175 Million Equity Financing
in our pipeline, exercise collaboration rights
where appropriate and continue building a
differentiated antiviral discovery engine.
Looking Ahead
In 2026, Assembly Bio will continue advancing
our current programs with the same scienti   c
rigor and operational discipline that have de   ned
our progress to date. Along with our ongoing
clinical programs, we expect to see further
progress in our new compound discovery efforts.
We are also evaluating partnering opportunities
to support the continued development of ABI4334, our highly potent next-generation capsid
assembly modulator designed to disrupt the
replication cycle of hepatitis B virus.
With Gilead exercising the option to license our
HPI program, ongoing innovation emanating
from our discovery engine, a strong cash runway
and encouraging clinical signals across multiple
modalities, we believe Assembly Bio is well
positioned for the next stages of value creation.
I want to extend my gratitude to our team,
whose dedication and expertise drive every
milestone we achieve, and to our stockholders,
whose support enables us to pursue innovation
with purpose and urgency. We look forward
to another year of clinical progress as we work
to bring meaningful antiviral therapies to the
patients who need them most.
In August, we announced the pricing of
$175 million in equity    nancings, comprising
an underwritten public offering and concurrent
private placement with Gilead. These transactions
included participation from a distinguished
group of new and existing healthcare-focused
institutional investors.
Sincerely,
This capital raise enhances our balance sheet
and positions Assembly Bio to invest con   dently
Jason A. Okazaki
Chief Executive Of   cer and President


shareholder letter icon 4/22/2026 Letter Continued (Full PDF)
 

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