Applied Molecular Transport Provides Strategy Update
May 18 2022 - 8:00AM
Applied Molecular Transport Inc. (Nasdaq: AMTI) (AMT), a
clinical-stage biopharmaceutical company, today announced strategic
actions to focus resources on its lead clinical programs.
Strategic Actions Summary:
- Prioritizing the advancement of
AMT-101 into late-stage clinical development
- Preparing for end of Phase 2
meetings with FDA and other regulators to advance AMT-101 to Phase
3 in chronic pouchitis, an orphan indication with no FDA-approved
products
- Completing the remaining three
AMT-101 Phase 2 trials with top-line data readouts in 2022,
consistent with previous guidance
- Evaluating next steps for AMT-126,
which recently demonstrated safety and tolerability in a Phase 1a
trial in healthy volunteers
- Pausing earlier-stage research
programs and activities
- Aligning senior management to
support the late-stage focus of the company
- Shawn Cross named president and
chief operating officer
- Brandon Hants assumes role of chief
financial officer
- Randy Mrsny, Ph.D., stepping down
as chief scientific officer
- Reducing workforce by approximately
40%, to 81 full-time employees, and focusing on execution of
late-stage clinical trials and related CMC activities
- The company expects to record a
one-time charge, primarily related to severance, in the second
quarter of 2022; strategic prioritization extends estimated cash
runway into 2024
“Given the recent positive AMT-101 Phase 2
results in chronic pouchitis, and its broad potential in additional
indications, we have taken these strategic actions to prioritize
our cash resources to support late-stage clinical advancement,
including an anticipated Phase 3 trial in chronic pouchitis, as
well as the ongoing Phase 2 trials in UC and RA,” said Tahir
Mahmood, Ph.D., chief executive officer and co-founder of AMT. “We
also continue to explore partnership opportunities for our earlier
stage programs and technology platform.”
Dr. Mahmood continued, “I also want to
acknowledge the foundational contributions of AMT’s co-founder
Randy Mrsny to the technology platform that underpins our product
candidates. It has been my great pleasure and honor to work
alongside Randy to build AMT in order to create and advance novel
oral biologic therapeutics.”
“Parting with the employees who have brought AMT
to such an advanced stage is a difficult decision. We thank our AMT
colleagues for their contributions to our progress thus far,”
concluded Dr. Mahmood.
About AMT-101AMT-101 is a novel GI-selective,
oral fusion of IL-10 and AMT’s proprietary carrier molecule,
currently in development in Phase 2 clinical trials for chronic
pouchitis, UC and RA. AMT-101 is designed to cross the intestinal
epithelial (IE) barrier with limited entry into the bloodstream,
thereby focusing IL-10 at the primary site of inflammation in IBD,
along the intestinal tissue lamina propria, potentially avoiding
the side effects observed with systemic administration.
About AMT-126AMT-126 is a novel GI-selective,
oral fusion of IL-22 and AMT’s proprietary carrier molecule for
diseases related to IE barrier defects. IL-22 is a cytokine that
repairs structural and functional defects of the IE barrier and
induces microbial defense. AMT-126 is designed to act locally on
the epithelial cells of the intestinal tissue, thereby repairing
the IE barrier and supporting mucosal healing, potentially
translating into clinically meaningful improvements in a broad
range of GI-focused, peripheral inflammatory and other
diseases.
About Applied Molecular Transport
Inc.AMT is a clinical-stage biopharmaceutical company
developing novel oral biologic product candidates, by leveraging
its technology platform to design biologic product candidates in
patient friendly oral dosage forms. AMT’s product candidates are
designed to precisely target the relevant pathophysiology of
disease. AMT’s proprietary technology platform is incorporated in
its product candidates, exploiting existing natural cellular
trafficking pathways to drive the active transport of diverse
therapeutic modalities across the IE barrier. Active transport is
an efficient mechanism that utilizes the cell’s own machinery to
transport materials across the IE barrier.
AMT’s headquarters, internal GMP manufacturing
and lab facilities are located in South San Francisco, CA. For
additional information on AMT, please visit
www.appliedmt.com.
Forward-Looking Statements
This press release contains forward-looking statements as that
term is defined in Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Such
forward-looking statements involve substantial risks and
uncertainties. All statements other than statements of historical
facts contained in this press release are forward-looking
statements including statements relating to AMT’s plans,
expectations, forecasts and future events. Such forward-looking
statements include, but are not limited to, the potential of, and
expectations regarding AMT’s technology platform, statements
relating to the Company’s business plans, including potential
partnership opportunities, statements relating to the Company’s
strategic prioritization and its impacts, statements regarding the
potential of AMT-101 and AMT-126 or regarding AMT-101 and AMT-126’s
clinical trials, including the timing of data readouts from such
trials, advancing product candidates to future phases of
development, and program updates, milestones for such trials, and
our ability to replicate past clinical development strategies, and
statements regarding the potential for AMT’s product candidates to
treat or provide clinically meaningful outcomes for certain medical
conditions or diseases and the potential to avoid side effects with
our product candidates. In some cases, you can identify
forward-looking statements by terminology such as “believe,”
“estimate,” “intend,” “may,” “plan,” “potentially,” “will,”
“expect,” “enable,” “likely” or the negative of these terms or
other similar expressions. We have based these forward-looking
statements largely on our current expectations and projections
about future events and trends that we believe may affect our
financial condition, results of operations, business strategy and
financial needs. Actual events, trends or results could differ
materially from the plans, intentions and expectations disclosed in
these forward-looking statements based on various factors.
Information regarding the foregoing and additional risks may be
found in the section entitled “Risk Factors” in AMT’s Annual and
Quarterly Reports on Form 10-K and 10-Q filed with the Securities
and Exchange Commission (the “SEC”), and AMT’s future reports to be
filed with the SEC. These forward-looking statements are made as of
the date of this press release, and AMT assumes no obligation to
update the forward-looking statements, or to update the reasons why
actual results could differ from those projected in the
forward-looking statements, except as required by law.
Investor Relations Contact:Andrew ChangHead,
Investor Relations & Corporate
Communicationsachang@appliedmt.com
Media Contacts:Alexandra SantosWheelhouse Life
Science Advisorsasantos@wheelhouselsa.com
Aljanae ReynoldsWheelhouse Life Science
Advisorsareynolds@wheelhouselsa.com
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