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.

 •  4/23/2025 Letter Continued (Full PDF)
 •  4/12/2023 ASMB Stockholder Letter
 •  4/17/2024 ASMB Stockholder Letter
 •  More "Biotechnology" Category Stockholder Letters
 •  ASMB Benford's Law Stock Score = 74

ASMB Shareholder/Stockholder Letter Transcript:

2024 Annual Report

To Our Stockholders,
2024 was a consequential year for
Assem
Assembly
Bio highlighted by strong
performance in the pursuit of our
perfor
mission to advance the treatment
paradigm for people living with
paradig
viral diseases.
serious v
notably, we took major steps
Most nota
to advance our expanded antiviral
Our goal was to bring multiple
pipeline. Ou
differentiated development programs
differentiate
and viral hepatitis
targeting herpesviruses
her
into the clinic. Driven by the expertise
dedication of our small but
and tireless ded
highly talented tteam, we delivered on that
commitment.
with four development candidates
We enter 2025 wit
across three therapeutic
in clinical studies a
high unmet medical need and,
indications with hi
portfolio advancements
thanks to the signi   cant
signi
year, we are well-positioned
made during the past
p
milestones this year
to achieve major upcoming
u
progress.
and fuel our continued
contin
Answering the Call for Novel Antivirals for
Herpesviruses
The strength of our clinical execution was
evidenced by our pipeline programs in recurrent
genital herpes, where we initiated Phase 1a/b
clinical studies of our two long-acting herpes
simplex virus (HSV) helicase-primase inhibitor
development candidates, ABI-5366 and ABI-1179.
Both ABI-5366, discovered here at Assembly Bio,
and ABI-1179, licensed from our partner Gilead
Sciences, Inc. (Gilead), offer promise for delivering
long overdue innovation in the treatment of
recurrent genital herpes, which signi   cantly
impacts the lives of over four million people
in the United States and Europe. With no new
therapeutic options approved in over 25 years,
there is an urgent need for innovative therapies
that can elevate the current standard of care.
Today, people living with the serious health
impacts of recurrent genital herpes have
treatment options that often fall short in
meeting their needs. The current standard of
care, given as daily suppressive therapy, offers
limited ef   cacy in preventing recurrences and
reducing transmission.
Reinforcing Our HSV Development Strategy
with Positive Data
ABI-5366 and ABI-1179 have shown potential to
deliver ef   cacy that is superior to the standard
of care and provide long-acting therapeutic
solutions that can improve patient adherence
and clinical outcomes. In Phase 1a, both
ABI-5366 and ABI-1179 exceeded our target
pharmacokinetic (PK) pro   le objectives for
each study, with data supporting the potential
for once-monthly and once-weekly oral dosing
pro   les, respectively. These interim results
reinforced our belief in the promise of both of
these investigational therapies and provide
compelling evidence that supports our ongoing
development strategy.
Based on these positive data, we have
subsequently moved both candidates into the
Phase 1b portion of the ongoing studies and
began dosing for ABI-5366 in participants with
recurrent genital herpes in the fourth quarter of
2024. We will conduct the Phase 1b evaluation
concurrently for each program using equivalent
eligibility criteria and outcome measures for
both candidates. Our goal is to reach another
critical clinical milestone in 2025: delivering new
meaningful data     including antiviral activity    
from the Phase 1b studies for ABI-5366 and ABI1179 in the fall.

Responding to the Life-Threatening
Consequences of Chronic HDV
Our team made important strides during
the past year in our efforts to address unmet
needs in chronic hepatitis D virus (HDV), a lifethreatening disease with limited treatment
options. Between 12-72 million people globally
are believed to be chronically infected with HDV
with 70% progressing to cirrhosis within 10 years.
Our novel small molecule entry inhibitor, ABI6250, has the potential to be the    rst oral
therapy for HDV. With a preclinical pro   le that
demonstrates its potential potency, safety and
tolerability, we believe ABI-6250 has a signi   cant
opportunity to simplify the treatment of HDV
through an oral medication that can enhance
treatment uptake and diagnosis rates.
We are further exploring the potential of ABI6250 in the clinic through a    rst-in-human Phase
1a study initiated in late 2024. The ongoing trial is
evaluating single and multiple ascending doses
of ABI-6250 in healthy participants. In addition to
safety and PK, outcomes in this Phase 1a study
will include a biomarker of target engagement.
Our team is excited to advance this promising
compound, and we look forward to sharing our
progress in the third quarter of 2025.
Solving Undertreatment Challenges in HBV
We also continued our progress for ABI-4334,
which we are evaluating for the treatment
of chronic hepatitis B virus (HBV) infection.
HBV is a highly pervasive, debilitating and lifethreatening disease that is urgently in need
of therapeutic change. It impacts 254 million
individuals worldwide and is the leading
cause of chronic liver disease and the need
for liver transplantation. HBV is signi   cantly
underdiagnosed and undertreated with only
seven million people receiving treatment, a
contributing factor to the 1.1 million deaths that
occur due to HBV-related causes per year.
ABI-4334 has the opportunity to improve
outcomes in HBV, where no new therapeutic
mechanisms of action have been approved
in over 25 years. As our most potent, nextgeneration capsid assembly modulator, ABI-4334
has been optimized to potently disrupt both viral
replication as well as replenishment of covalently
closed circular DNA (cccDNA), the viral reservoir
that drives HBV persistence. In the ongoing
Phase 1b study of ABI-4334, we were pleased to
achieve positive interim results from our    rst
cohort that con   rmed strong antiviral activity
and a favorable safety pro   le. The    nal cohort is
ongoing and we anticipate a readout of the rest
of the clinical data from this study in
the    rst half of 2025.
Researching New Antiviral Targets
Further, we nominated a new
development candidate: ABI-7423, an oral
broad-spectrum non-nucleoside polymerase
inhibitor (NNPI) for transplant-associated
herpesviruses.
While there are approved antivirals that are
administered in a transplant setting, they are not
active against a broad spectrum of transplantassociated herpesviruses and pose the risk of
potentially serious side effects and drug-drug
interactions. As a result of these limitations, we
see signi   cant opportunity for ABI-7423 and have
commenced IND-/CTA-enabling studies.
Strengthening Our Collaboration with Gilead
2024 also brought further investment from
our partner Gilead, building upon our global
collaboration agreement announced in 2023. The
partnership combines Gilead   s pioneering vision
with Assembly Bio   s deep R&D expertise to bring
next-generation virology medicines to patients.
In December 2024, Gilead invested an additional
$30.1 million in Assembly Bio, inclusive of a $20.1
million equity investment and $10 million in
accelerated funding. The investment will be an
important catalyst for rapidly advancing our
pipeline programs in the clinic and reaching our
key data readout targets in the year ahead. The
additional funding also extends our cash runway
to mid-2026.
The past year has brought meaningful and
important progress for Assembly Bio. The
steps we have taken provide us with a solid
foundation to build upon our accomplishments
in the year ahead. I could not be prouder to
lead our accomplished and passionate team
who, each and every day, demonstrate their
commitment to science and dedication to the
patients and families that count on us. Together,
we look forward to the work ahead, united in
purpose and intention in our mission to advance
innovation and change lives.
On behalf of all of us at Assembly Bio, thank
you for your continued support.
Sincerely,
Jason A. Okazaki
Chief Executive Of   cer and President



 4/23/2025 Letter Continued (Full PDF)