Kala Pharmaceuticals Announces Up to $31 Million Private Placement Financing
November 28 2022 - 4:01PM
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, today announced that it has entered into a definitive
agreement with a life sciences-focused investor for the sale, in a
private placement priced at-the-market under Nasdaq rules, of
shares of its common stock and Series E Convertible Non-Redeemable
Preferred Stock (Series E Preferred) in two tranches for gross
proceeds of up to $31 million.
Under the terms of the agreement, Kala has agreed to sell in a
first tranche an aggregate of 76,813 shares of its common stock at
a price of $5.75 per share and an aggregate of 9,666 shares of its
Series E Preferred at a price of $575.00 per share, for gross
proceeds of approximately $6 million. The first tranche is expected
to close on or about December 1, 2022. In addition, subject to
acceptance by the U.S. Food and Drug Administration (FDA) of Kala’s
investigational new drug (IND) application for KPI-012 in
persistent corneal epithelial defect (PCED), the investor has
agreed to purchase in a second tranche an aggregate of 43,478
shares of Series E Preferred at a price of $575.00 per share, for
gross proceeds of approximately $25 million.
Kala intends to use proceeds from the financing to advance the
clinical development of KPI-012 for the treatment of PCED, as well
as for general corporate purposes.
The securities to be sold in the private placement have not been
registered under the Securities Act of 1933, as amended, or
applicable state securities laws, and may not be offered or sold
in the United States except pursuant to an effective
registration statement or an applicable exemption from the
registration requirements.
This press release shall not constitute an offer to sell or the
solicitation of an offer to buy, nor shall there be any sale of
securities of Kala in any state or other jurisdiction in which such
offer, solicitation or sale would be unlawful prior to the
registration or qualification under the securities laws of any such
state or jurisdiction.
About KPI-012 for Persistent Corneal Epithelial Defect
(PCED)Persistent corneal epithelial defect, which is
defined as a persistent non-healing corneal defect or wound that is
refractory to conventional treatments, is a rare disease with an
estimated incidence in the United States of 100,000 cases per year.
PCED can have various etiologies, including neurotrophic keratitis,
surgical epithelial debridement, microbial/viral keratitis, corneal
transplant, limbal stem cell deficiency and mechanical and chemical
trauma and, if left untreated, can lead to infection, corneal
ulceration or perforation, scarring, opacification and significant
vision loss.
Based on its multifactorial mechanism of action and preclinical
and clinical data generated to-date, Kala believes KPI-012 may
represent a significant advancement in the treatment of PCED and
could become the first approved treatment for PCED across all its
various etiologies. Kala intends to initiate a Phase 2b clinical
trial evaluating the efficacy and safety of two doses of KPI-012 in
PCED patients with a broad range of underlying etiologies in the
fourth quarter of 2022. If positive, this trial could serve as the
first of two pivotal trials needed to support the submission of a
Biologics License Agreement (BLA) to the U.S. Food and Drug
Administration.
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 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 designation from the U.S. Food and Drug Administration.
Kala is also targeting the potential development of 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 potential utility of
its MSC-S platform for retinal degenerative diseases.
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 the expected closings for the private placement,
the anticipated use of proceeds from the private placement 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: whether the conditions for
the closing of each tranche of the private placement will be
satisfied; Kala’s ability to maintain its listing on the Nasdaq
Global Select Market; Kala’s ability to comply with the covenants
under its outstanding loan agreement; 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, including the
planned Phase 2b clinical trial; uncertainties associated with
regulatory review of clinical trials and applications for marketing
approvals; Kala’s ability to retain and hire key personnel; 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 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 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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