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.

To Our Stockholders:
Last year, our team at Assembly Bio signi cantly
advanced our preclinical and clinical pipelines
and embarked on an important long-term
collaboration that set the stage for an exciting
2024 and beyond. We remain steadfast in our
dedication to changing the treatment paradigm
for serious viral diseases. The impressive progress
we ve made during the past year positions us to
be a catalyst of therapeutic change that millions
of individuals living with these chronic viral
infections and their families deserve.
Our mission to deliver novel antiviral therapies
continues to take place against a backdrop of
pervasive unmet medical needs. Innovation
is urgently needed to treat diseases such as
recurrent genital herpes, in which only onethird of persons with high recurrence that are
taking the standard-of-care antivirals make it
through a year without recurrence. Treatment
options are similarly limited in chronic hepatitis
D virus (HDV), a life-threatening disease that is
signi cantly underdiagnosed and where 70% of
patients progress to cirrhosis in 10 years. And, in
chronic hepatitis B virus (HBV), a leading cause
of liver cancer, there remains a paramount need
for a functional cure for the nearly 300 million
people living with HBV around the world.
Navigating a Path Forward
Through Novel Science
Much work remains to stem the impact that
viruses can have on our daily life. In recent years,
the pandemic elevated that impact in our public
health discourse, but even more importantly,
showed us the critical role that scienti c
innovation plays in protecting and saving lives.
Discovering and developing novel therapies for
serious viral diseases requires an unwavering
commitment to science. That s what drives our
team of virology experts as they lead the path
to innovation. Together, we embrace a bold
agenda to advance new treatment options
and a commitment to succeed on behalf of
the patients that count on us. The depth and
breadth of our viral discovery efforts have yielded
product candidates with exciting potential
four of which we expect to move into the clinic
in 2024.
Improving Outcomes for Individuals
Living with Chronic Viral Infections
Our singular purpose of creating meaningful
medical change in the treatment of serious
viral diseases is exempli ed by our therapeutic
pipeline. We ve made considerable progress over
the past few years in strategically diversifying
our discovery and development efforts in
herpesviruses and HDV. In 2023, those efforts
coalesced in the nominations of two new
product candidates: ABI-5366, a long-acting
helicase-primase inhibitor for recurrent genital
herpes resulting from herpes simplex virus (HSV)
infections; and ABI-6250, our small molecule
entry inhibitor for HDV.

Both of these indications have been underserved
for decades and patients are waiting for
innovative therapeutics that will deliver
improved outcomes. Our team is answering their
call with urgency in our clinical development
strategy. First-in-human studies for ABI-5366 are
anticipated to start by mid-year 2024, with initial
data expected during the third quarter and
Phase 1b studies in individuals with recurrent
genital herpes anticipated to start by the end of
the year. ABI-6250 is targeted for clinical entry by
year-end.
Our team has made exceptional
progress in building our portfolio
and establishing the foundation that
will support our ongoing growth
and future success. Leaning on the
strength of our greatest asset our
dedicated team we remain keenly
focused on execution.
Building upon our pioneering heritage in the
development of capsid assembly modulators
(CAMs) for HBV, we also remain encouraged
by the potential of our next-generation CAM,
ABI-4334. We applied our learnings from our
rst-generation CAM candidate, vebicorvir, to
develop a more potent CAM optimized against
a mechanism of action targeting the formation
of the HBV reservoir, cccDNA. We completed our
Phase 1a clinical study of ABI-4334 in 2023 and
are planning to initiate Phase 1b studies by mid2024 with initial data expected by end of year.
Accelerating the Delivery
of Novel Antivirals
In 2023, Assembly Bio also took a signi cant
step in our journey toward clinical development
and commercialization of our virology portfolio
through the announcement of our long-term
partnership with Gilead Sciences, Inc.
By combining our early-stage R&D and clinical
development expertise with Gilead s late-stage
program experience and proven commercial
capabilities, the partnership is mutually
bene cial for both companies and a potential
value driver for patients and stockholders. In
addition to an upfront $100 million payment,
including equity investment, Gilead has already
augmented our pipeline with the contribution
of two of their novel herpesvirus programs as
part of the collaboration. The rst candidate
licensed from Gilead, ABI-1179, a long-acting HSV
helicase-primase inhibitor for recurrent genital
herpes, is also anticipated to enter the clinic by
the end of 2024.
Looking Ahead
Our team has made exceptional progress in
building our portfolio and establishing the
foundation that will support our ongoing growth
and future success. Leaning on the strength
of our greatest asset our dedicated and
passionate team we remain keenly focused
on execution. Our expertise and capabilities to
achieve clinical success on the road ahead were
strengthened even further in 2023 with the
addition of Anuj Gaggar, M.D., Ph.D., an infectious
disease specialist who joined our company as
chief medical of cer.
All of these 2023 developments positioned us
well to continue our important progress as we
embark on the path ahead. In parallel with this
exciting progress, we also continue to carefully
manage our cash position, with our runway
projected into the second half of 2025.
On behalf of our entire team at Assembly Bio,
thank you for your continued support. Our work
to change the lives of individuals living with
serious viral diseases and their families has never
been more important. We look to the future,
hopeful and optimistic for the advances that
lie ahead.
Sincerely,
We believe Gilead s established success in
developing and commercializing antiviral
medicines and Assembly Bio s deep virology
research expertise will help advance a wave of
innovation in virology. The partnership between
these two companies strengthens our portfolio
and furthers our efforts toward the development
and commercialization of differentiated
treatments for herpesviruses, HDV, HBV and
other viral indications.
Jason A. Okazaki
Chief Executive Of cer and President

•

4/17/2024 Letter Continued (Full PDF)
•

4/12/2023 ASMB Stockholder Letter
•

More "Biotechnology" Category Stockholder Letters
•

ASMB Benford's Law Stock Score = 64

ASMB Shareholder/Stockholder Letter Transcript:

2023 Annual Report

To Our Stockholders:
Last year, our team at Assembly Bio signi cantly
advanced our preclinical and clinical pipelines
and embarked on an important long-term
collaboration that set the stage for an exciting
2024 and beyond. We remain steadfast in our
dedication to changing the treatment paradigm
for serious viral diseases. The impressive progress
we ve made during the past year positions us to
be a catalyst of therapeutic change that millions
of individuals living with these chronic viral
infections and their families deserve.
Our mission to deliver novel antiviral therapies
continues to take place against a backdrop of
pervasive unmet medical needs. Innovation
is urgently needed to treat diseases such as
recurrent genital herpes, in which only onethird of persons with high recurrence that are
taking the standard-of-care antivirals make it
through a year without recurrence. Treatment
options are similarly limited in chronic hepatitis
D virus (HDV), a life-threatening disease that is
signi cantly underdiagnosed and where 70% of
patients progress to cirrhosis in 10 years. And, in
chronic hepatitis B virus (HBV), a leading cause
of liver cancer, there remains a paramount need
for a functional cure for the nearly 300 million
people living with HBV around the world.
Navigating a Path Forward
Through Novel Science
Much work remains to stem the impact that
viruses can have on our daily life. In recent years,
the pandemic elevated that impact in our public
health discourse, but even more importantly,
showed us the critical role that scienti c
innovation plays in protecting and saving lives.
Discovering and developing novel therapies for
serious viral diseases requires an unwavering
commitment to science. That s what drives our
team of virology experts as they lead the path
to innovation. Together, we embrace a bold
agenda to advance new treatment options
and a commitment to succeed on behalf of
the patients that count on us. The depth and
breadth of our viral discovery efforts have yielded
product candidates with exciting potential
four of which we expect to move into the clinic
in 2024.
Improving Outcomes for Individuals
Living with Chronic Viral Infections
Our singular purpose of creating meaningful
medical change in the treatment of serious
viral diseases is exempli ed by our therapeutic
pipeline. We ve made considerable progress over
the past few years in strategically diversifying
our discovery and development efforts in
herpesviruses and HDV. In 2023, those efforts
coalesced in the nominations of two new
product candidates: ABI-5366, a long-acting
helicase-primase inhibitor for recurrent genital
herpes resulting from herpes simplex virus (HSV)
infections; and ABI-6250, our small molecule
entry inhibitor for HDV.

Both of these indications have been underserved
for decades and patients are waiting for
innovative therapeutics that will deliver
improved outcomes. Our team is answering their
call with urgency in our clinical development
strategy. First-in-human studies for ABI-5366 are
anticipated to start by mid-year 2024, with initial
data expected during the third quarter and
Phase 1b studies in individuals with recurrent
genital herpes anticipated to start by the end of
the year. ABI-6250 is targeted for clinical entry by
year-end.
Our team has made exceptional
progress in building our portfolio
and establishing the foundation that
will support our ongoing growth
and future success. Leaning on the
strength of our greatest asset our
dedicated team we remain keenly
focused on execution.
Building upon our pioneering heritage in the
development of capsid assembly modulators
(CAMs) for HBV, we also remain encouraged
by the potential of our next-generation CAM,
ABI-4334. We applied our learnings from our
rst-generation CAM candidate, vebicorvir, to
develop a more potent CAM optimized against
a mechanism of action targeting the formation
of the HBV reservoir, cccDNA. We completed our
Phase 1a clinical study of ABI-4334 in 2023 and
are planning to initiate Phase 1b studies by mid2024 with initial data expected by end of year.
Accelerating the Delivery
of Novel Antivirals
In 2023, Assembly Bio also took a signi cant
step in our journey toward clinical development
and commercialization of our virology portfolio
through the announcement of our long-term
partnership with Gilead Sciences, Inc.
By combining our early-stage R&D and clinical
development expertise with Gilead s late-stage
program experience and proven commercial
capabilities, the partnership is mutually
bene cial for both companies and a potential
value driver for patients and stockholders. In
addition to an upfront $100 million payment,
including equity investment, Gilead has already
augmented our pipeline with the contribution
of two of their novel herpesvirus programs as
part of the collaboration. The rst candidate
licensed from Gilead, ABI-1179, a long-acting HSV
helicase-primase inhibitor for recurrent genital
herpes, is also anticipated to enter the clinic by
the end of 2024.
Looking Ahead
Our team has made exceptional progress in
building our portfolio and establishing the
foundation that will support our ongoing growth
and future success. Leaning on the strength
of our greatest asset our dedicated and
passionate team we remain keenly focused
on execution. Our expertise and capabilities to
achieve clinical success on the road ahead were
strengthened even further in 2023 with the
addition of Anuj Gaggar, M.D., Ph.D., an infectious
disease specialist who joined our company as
chief medical of cer.
All of these 2023 developments positioned us
well to continue our important progress as we
embark on the path ahead. In parallel with this
exciting progress, we also continue to carefully
manage our cash position, with our runway
projected into the second half of 2025.
On behalf of our entire team at Assembly Bio,
thank you for your continued support. Our work
to change the lives of individuals living with
serious viral diseases and their families has never
been more important. We look to the future,
hopeful and optimistic for the advances that
lie ahead.
Sincerely,
We believe Gilead s established success in
developing and commercializing antiviral
medicines and Assembly Bio s deep virology
research expertise will help advance a wave of
innovation in virology. The partnership between
these two companies strengthens our portfolio
and furthers our efforts toward the development
and commercialization of differentiated
treatments for herpesviruses, HDV, HBV and
other viral indications.
Jason A. Okazaki
Chief Executive Of cer and President

4/17/2024 Letter Continued (Full PDF)

ASMB Shareholder/Stockholder Letter Transcript:

ASMB Stockholder/Shareholder Letter (ASSEMBLY BIOSCIENCES, INC.) | www.StockholderLetter.com Copyright © 2023 - 2025, All Rights Reserved

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Copyright © 2023 - 2025, All Rights Reserved