Kala Pharmaceuticals Completes Sale of EYSUVIS® and INVELTYS® to Alcon Inc
July 11 2022 - 8:00AM
Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a clinical-stage
biopharmaceutical company dedicated to the research, development
and commercialization of innovative therapies for rare diseases of
the eye, announced today that it has completed the sale of its
commercial portfolio and related intellectual property assets to
Alcon Inc., a transaction that was announced on May 23, 2022. The
sale included EYSUVIS, the first and only U.S. Food and Drug
Administration approved medicine for the short-term (up to two
weeks) treatment of the signs and symptoms of dry eye disease, and
INVELTYS, a twice-a-day corticosteroid for the treatment of
post-operative inflammation and pain following ocular surgery.
Under the terms of the transaction, Kala received an upfront
payment of $60 million in cash at closing and is eligible to
receive commercial-based milestone payments. Kala anticipates that
its existing cash resources, together with the net payments
received at the closing of the Alcon transaction and planned
reductions in operating expenses, will enable it to fund its
operations into the second quarter of 2024.
“The completion of this sale marks a significant transformation
of our company, as we pivot our efforts to focus on the advancement
of KPI-012, our novel biologic with the potential to improve the
treatment of multiple rare ophthalmic conditions,” said Mark
Iwicki, Chief Executive Officer and Chairman of Kala. “As we enter
the second half of 2022, we are operating from an enhanced
financial position, with sufficient capital to fund our operations
beyond the planned data readout from our Phase 2/3 trial of KPI-012
for persistent corneal epithelial defect. We expect to initiate
this study in the fourth quarter of 2022, as we continue to pursue
our commitment to developing innovative products that can better
treat rare, underserved diseases of the eye.”
Piper Sandler acted as exclusive financial advisor and Wilmer
Cutler Pickering Hale and Dorr LLP served as legal counsel to
Kala.
About Kala Pharmaceuticals, Inc.Kala is a
clinical-stage biopharmaceutical company dedicated to the research,
development and commercialization of innovative therapies for rare
diseases of the eye. Kala’s biologics-based investigational
therapies utilize Kala’s proprietary Mesenchymal Stem Cell
Secretome (MSC-S) platform. Kala’s lead product candidate, KPI-012,
is in clinical development for the treatment of persistent corneal
epithelial defect (PCED), a rare disease of impaired corneal
healing, which has received orphan drug designation from the U.S.
Food and Drug Administration. Kala is also targeting KPI-012 for
the treatment of Partial Limbal Stem Cell Deficiency and ocular
manifestations of moderate-to-severe Sjögren's and plans to
initiate preclinical studies to evaluate the utility of its MSC-S
platform for retinal degenerative diseases, such as Retinitis
Pigmentosa and Stargardt Disease. For more information on Kala,
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’s future expectations, plans and prospects,
including but not limited to statements about Kala’s expectations
with respect to potential advantages of KPI-012; the future
development or commercialization of KPI-012; conduct and timelines
of clinical trials; the clinical utility of KPI-012 for PCED; plans
to pursue research and development of KPI-012 for other
indications; Kala’s ability to realize potential milestones
payments under the transaction with Alcon and the risk that Kala
may not realize the expected benefits of the transaction; the
sufficiency of Kala’s existing cash resources 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: Kala’s ability to realize the
anticipated benefits of the transaction with Alcon, including the
uncertainty regarding the receipt of any milestone payments; the
impact of extraordinary external events, such as the current
pandemic health event resulting from the novel coronavirus
(COVID-19), and their collateral consequences; the 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;
uncertainties associated with regulatory review of clinical trials
and applications for marketing approvals; Kala’s ability to retain
and hire key personnel; the sufficiency of cash resources and need
for additional financing and other important factors, any of which
could cause the Kala’s actual results to differ from those
contained in the forward-looking statements, discussed in the “Risk
Factors” section of Kala’s Annual Report on Form 10-K, most
recently filed Quarterly Report on Form 10-Q and other filings Kala
makes with the Securities and Exchange Commission. These
forward-looking statements represent Kala’s views as of the date of
this press release and should not be relied upon as representing
the Kala’s views as of any date subsequent to the date hereof. Kala
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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