Kala Pharmaceuticals Announces Name Change to KALA BIO
August 02 2023 - 8:00AM
Kala Pharmaceuticals, Inc. (Nasdaq:KALA), a clinical-stage
biopharmaceutical company dedicated to the research, development
and commercialization of innovative therapies for rare and severe
diseases of the eye, today announced that it will change its name
to KALA BIO, Inc. effective August 2, 2023, to better reflect the
company’s focus on advancing biologics for the treatment of
ophthalmic conditions. KALA BIO is progressing an innovative
pipeline built on its proprietary mesenchymal stem cell secretome
(MSC-S) platform, which is designed to provide a cell-free,
regenerative approach to disease management, with the potential to
treat multiple diseases of the front and back of the eye.
“KALA BIO is committed to developing innovative therapies for
rare and severe diseases of the eye,” said Mark Iwicki, Chair and
Chief Executive Officer of KALA BIO. “Our primary focus is the
utilization of our MSC-S platform to develop novel therapies for
ophthalmic diseases. Now that we are enrolling patients in the
CHASE (Corneal Healing
After SEcretome therapy) Phase 2b
clinical trial of KPI-012 for the treatment of persistent corneal
epithelial defect (PCED) and evaluating the potential development
of KPI-012 and KPI-014 for additional eye diseases, we believe it
is the perfect time to launch KALA BIO and highlight our new
mission of delivering a suite of novel biologics to improve the
care and treatment of rare ocular diseases.”
KALA BIO’s MSC-S are produced by collecting the biomolecules
secreted by human bone marrow derived mesenchymal stem cells,
offering the potential for benefits similar to cell therapy while
avoiding the safety and logistical concerns that are associated
with existing cell therapy approaches. KALA BIO’s most advanced
MSC-S is KPI-012, which is currently in Phase 2b clinical
development for the treatment of PCED. KALA BIO believes the
multifactorial mechanism of action of KPI-012 makes it a platform
technology and is evaluating the potential development of KPI-012
for additional rare, front-of-the-eye diseases, such as Limbal Stem
Cell Deficiency. KALA BIO has also initiated preclinical studies
for its KPI-014 program, evaluating the utility of its MSC-S
platform for inherited retinal degenerative diseases, such as
Retinitis Pigmentosa and Stargardt Disease.
In connection with the name change, KALA BIO’s corporate website
address remains unchanged at www.kalarx.com. The company’s common
stock will continue to be listed on The Nasdaq Capital Market under
the ticker symbol “KALA”, and trading on The Nasdaq Capital Market
under the new name is expected to commence on August 3, 2023. The
number of outstanding shares of the company’s common stock, and the
CUSIP number for the common stock are not affected by the name
change.
About KALA BIO
KALA BIO is a clinical-stage biopharmaceutical company dedicated
to the research, development and commercialization of innovative
therapies for rare and severe diseases of the eye. KALA BIO’s
biologics-based investigational therapies utilize KALA BIO’s
proprietary mesenchymal stem cell secretome (MSC-S) platform. KALA
BIO’s lead product candidate, KPI-012, is a human MSC-S, which
contains numerous human-derived biofactors, such as growth factors,
protease inhibitors, matrix proteins and neurotrophic factors that
can potentially correct the impaired corneal healing that is an
underlying etiology of multiple severe ocular diseases. KPI-012 is
currently in clinical development for the treatment of persistent
corneal epithelial defect (PCED), a rare disease of impaired
corneal healing, for which it has received Orphan Drug and Fast
Track designations from the U.S. Food and Drug Administration. KALA
BIO is also targeting the potential development of KPI-012 for the
treatment of Limbal Stem Cell Deficiency and other rare corneal
diseases that threaten vision and has initiated preclinical studies
to evaluate the potential utility of its MSC-S platform for retinal
degenerative diseases, such as Retinitis Pigmentosa and Stargardt
Disease. For more information on KALA BIO, please visit
www.kalarx.com.
Forward Looking Statements:
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
that involve substantial risks and uncertainties. Any statements in
this press release about KALA BIO’s future expectations, plans and
prospects, including but not limited to statements about KALA BIO’s
expectations with respect to potential advantages of KPI-012,
KPI-014 and its MSC-S platform; the clinical utility of KPI-012 for
PCED; KALA BIO’s plans to pursue research and development of
KPI-012 and its MSC-S platform for other indications; and other
statements containing the words “anticipate,” “believe,”
“estimate,” “expect,” “intend,” “may,” “plan,” “predict,”
“project,” “target,” “potential,” “likely,” “will,” “would,”
“could,” “should,” “continue,” and similar expressions constitute
forward-looking statements. Actual results may differ materially
from those indicated by such forward-looking statements as a result
of various important factors, including: uncertainties inherent in
the initiation and conduct of preclinical studies and clinical
trials; uncertainties regarding availability and timing of data
from clinical trials; whether results of early clinical trials or
trials in different disease indications will be indicative of the
results of ongoing or future trials; whether results of the Phase
1b clinical trial of KPI-012 will be indicative of results for any
future clinical trials and studies of KPI-012, including the CHASE
Phase 2b clinical trial; whether interim data from a clinical trial
will be predictive of the results of the trial; uncertainties
associated with regulatory review of clinical trials and
applications for marketing approvals; KALA BIO’s ability to retain
and hire key personnel; the impact of extraordinary external
events, such as the pandemic health event resulting from the
coronavirus (COVID-19), and their collateral consequences; the
sufficiency of cash resources and need for additional financing and
other important factors, any of which could cause KALA BIO’s actual
results to differ from those contained in the forward-looking
statements, discussed in the “Risk Factors” section of KALA BIO’s
most recent quarterly report on Form 10-Q and other filings KALA
BIO makes with the Securities and Exchange Commission. These
forward-looking statements represent KALA BIO’s views as of the
date of this press release and should not be relied upon as
representing KALA BIO’s views as of any date subsequent to the date
hereof. KALA BIO does not assume any obligation to update any
forward-looking statements, whether as a result of new information,
future events or otherwise, except as required by law.
Investor Contact:
Hannah Deresiewiczhannah.deresiewicz@sternir.com
212-362-1200
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