WALTHAM, Mass.--(BUSINESS WIRE)--May 10, 2018--
Kala Pharmaceuticals, Inc. (NASDAQ:KALA), a biopharmaceutical company
focused on the development and commercialization of product candidates
using its proprietary mucus-penetrating particle (MPP) technology with
an initial focus on the treatment of eye diseases, today reported
financial results for the quarter ended March 31, 2018.
"Following the acceptance of our New Drug Application (NDA) by the U.S.
Food and Drug Administration (FDA) for INVELTYS™ for the treatment of
inflammation and pain following ocular surgery, our focus during the
first quarter of 2018 has been on strengthening our commercial team
ahead of the potential FDA approval for INVELTYS," said Mark Iwicki,
Chairman and Chief Executive Officer. "We remain excited about our
ophthalmology programs, including KPI-121 0.25%, our product candidate
for dry eye disease, as we continue advancing these programs toward
approval and commercialization."
Recent Corporate Highlights
Received notification from the FDA of acceptance of our NDA filing for
INVELTYS. If approved, INVELTYS could be the first FDA-approved
twice-daily ocular corticosteroid indicated for the treatment of
post-operative ocular inflammation and pain.
Strengthened the management team with the appointment of Eric
Trachtenberg as General Counsel and Corporate Secretary.
Mr. Trachtenberg formerly served as General Counsel, Chief Compliance
Officer and Corporate Secretary of Aralez Pharmaceuticals, Inc. since
Presented at the "Spotlight on Dry Eye" session at the Ophthalmology
Innovation Summit at the American Society of Cataract and Refractive
Surgery Annual Meeting (OIS @ ASCRS).
Presented safety and efficacy data of INVELTYS for the treatment of
inflammation and pain following ocular surgery at the American Society
of Cataract and Refractive Surgery (ASCRS) Annual Meeting.
Strengthened commercial organization in preparation for the potential
approval and launch of INVELTYS with the following key hires:
Kathleen McCann Kline, Vice President of Marketing
James Patnoe, Vice President of Commercial Operations and Pricing
Carl Rennie, Executive Director of Account Management
Patrick Bedell, Executive Director of Trade and Alternate Channels
Lynette Zickl, Director of Commercial Analytics and Forecasting
Upcoming Milestones and Events
Mark Iwicki will provide a corporate overview at the Bank of America
Merrill Lynch 2018 Healthcare Conference on Tuesday, May 15, 2018 and
at the Jefferies 2018 Global Healthcare Conference on Tuesday, June 5,
PDUFA target action date of August 24, 2018 for INVELTYS.
First Quarter 2018 Financial Results
Cash Position: As of March 31, 2018, Kala had cash of $100.5
million compared to $114.6 million as of December 31, 2017. Kala
anticipates that its existing cash on hand will enable it to fund
operations through at least the next twelve months.
R&D Expenses: For the quarter ended March 31, 2018,
research and development expenses were $5.7 million compared to $8.0
million for the same period in 2017. The decrease in research and
development expenses is primarily due to a decrease in costs
associated with our Phase 3 clinical trial of INVELTYS, which
completed in the first half of 2017 and our two Phase 3 clinical
trials of KPI-121 0.25%, which completed during the fourth quarter of
G&A Expenses: General and administrative expenses for the
quarter ended March 31, 2018 were $5.5 million compared to $1.5
million for the same period in 2017. The increase in G&A expenses is
primarily attributable to an increase in personnel costs and
professional fees associated with operating as a public company, and
costs incurred in preparation for becoming a commercial organization.
Operating Loss: Loss from operations for the quarter
ended March 31, 2018 was $11.1 million compared to $9.6 million for
the same period in 2017.
Net Loss: Net loss was $11.3 million, or $0.46 per share, for
the quarter ended March 31, 2018, compared to a net loss of $9.8
million, or $8.26 per share, for the same period in 2017.
About INVELTYS™ (KPI-121 1%)
INVELTYS™ (KPI-121 1%) is a
twice-a-day corticosteroid for the treatment of inflammation and pain
following ocular surgery. INVELTYS utilizes Kala's proprietary
mucus-penetrating particle (MPP) technology to enhance penetration into
target tissues of the eye. In pre-clinical studies, MPP increased
delivery of a corticosteroid into ocular tissues more than three-fold by
facilitating penetration through the tear film mucus. Two Phase 3
clinical trials have been successfully completed for INVELTYS and
statistical significance was achieved for both primary efficacy
endpoints in both trials. In each of these trials, INVELTYS was well
tolerated with no treatment-related serious adverse events observed.
Kala believes INVELTYS has a favorable treatment profile compared to the
standard of care for the treatment of inflammation and pain following
ocular surgery, due to its twice-a-day dosing regimen and rapid onset of
About KPI-121 0.25%
Kala is developing KPI-121 0.25% for the
temporary relief of the signs and symptoms of dry eye disease utilizing
a two-week course of therapy administered four times a day. Dry eye
disease is a chronic, episodic, multifactorial disease affecting the
tears and ocular surface and can involve tear film instability,
inflammation, discomfort, visual disturbance and ocular surface damage.
KPI-121 0.25% utilizes Kala's mucus-penetrating particle (MPP)
technology to enhance penetration of loteprednol etabonate (LE) into
target tissue of the eye. In preclinical studies, MPP technology
increased delivery of LE into ocular tissues more than three-fold
compared to current LE products by facilitating penetration through the
tear film mucus. Kala has completed one Phase 2 and two Phase 3 clinical
trials of KPI-121 0.25%. Kala believes that KPI-121 0.25%'s broad
mechanism of action, rapid onset of relief of both signs and symptoms,
favorable tolerability and safety profile and the potential to be
complementary to existing therapies, could result in a favorable profile
for the management of dry eye flares and other dry eye associated
conditions which could benefit from temporary relief of dry eye signs
About Kala Pharmaceuticals, Inc.
Kala is a
biopharmaceutical company focused on the development and
commercialization of therapeutics using its proprietary
mucus-penetrating particle (MPP) technology, with an initial focus on
the treatment of eye diseases. Kala has applied the MPP technology to a
corticosteroid designed for ocular applications, resulting in two lead
product candidates. The product candidates are INVELTYS™ (KPI-121 1%)
for the treatment of inflammation and pain following ocular surgery, for
which an NDA has been accepted for review by the FDA, and KPI-121 0.25%
for the temporary relief of the signs and symptoms of dry eye disease.
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, including statements regarding the Company's product
candidates, including INVELTYS (KPI-121 1%) for the treatment of
inflammation and pain following ocular surgery and KPI-121 0.25% for the
temporary relief of the signs and symptoms of dry eye disease,
continuing to advance these programs toward approval and
commercialization, and the Company strengthening its commercial team
ahead of potential FDA approval for INVELTYS. All statements, other than
statements of historical facts, contained in this press release,
including statements regarding the Company's strategy, future
operations, future financial position, future revenue, projected costs,
prospects, plans and objectives of management, are forward-looking
statements. The words "anticipate," "believe," "estimate," "expect,"
"intend," "may," "plan," "predict," "project," "target," "potential,"
"will," "would," "could," "should," "continue" and similar expressions
are intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. The Company
may not actually achieve the plans, intentions or expectations disclosed
in its forward-looking statements, and you should not place undue
reliance on such forward-looking statements. Actual results or events
could differ materially from the plans, intentions and expectations
disclosed in the forward-looking statements as a result of various risks
and uncertainties including, but not limited to: whether the data from
our Phase 3 clinical trials of KPI-121 0.25% will warrant submission of
an NDA on the timeline expected, or at all, whether any additional
clinical trials will be required prior to submission of an NDA and
whether any such NDA will be approved; that topline data is based on
preliminary analysis of key efficacy and safety data, and such data
could change following a more comprehensive review and may not
accurately reflect the complete results of our clinical trials; that
post-hoc analyses are normally given less weight by regulatory
authorities than prespecified analyses; whether our NDA for INVELTYS
will be approved by its PDUFA date or at all; uncertainties inherent in
the availability and timing of data from ongoing clinical trials;
uncertainties related to our ability to obtain regulatory approvals to
conduct trials or to market products; whether the Company's cash
resources will be sufficient to fund the Company's foreseeable and
unforeseeable operating expenses and capital expenditure requirements
for the Company's expected timeline; other matters that could affect the
availability or commercial potential of the Company's product
candidates; and other important factors, any of which could cause the
Company's actual results to differ from those contained in the
forward-looking statements, discussed in the "Risk Factors" section of
the Company's most recently filed Annual Report on Form 10-K and other
filings the Company makes with the Securities and Exchange Commission.
These forward-looking statements represent the Company's views as of the
date of this release and should not be relied upon as representing the
Company's views as of any date subsequent to the date hereof. The
Company 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.
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Kala Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
|Total Stockholders’ Equity||80,271||89,679|
(1)The company defines working capital as current assets less current liabilities. See the Company’s consolidated financial statements for further details regarding its current assets and current liabilities.
Kala Pharmaceuticals, Inc.
Consolidated Statements of Operations
(In thousands, except share and per share data)
| || || || || |
Three Months Ended
|2018|| || || ||2017|
|Research and development||$||5,657||$||8,039|
|General and administrative|| ||5,482|| ||1,532|
|Total operating expenses|| ||11,139|| ||9,571|
|Loss from operations||(11,139)||(9,571)|
|Other income (expense):|
|Change in fair value of warrant liability|| ||—|| ||(36)|
|Total other income (expense)|| ||(158)|| ||(188)|
|Net loss per share—basic and diluted||$||(0.46)||$||(8.26)|
|Weighted average shares outstanding—basic and diluted|| ||24,542,428|| ||1,181,429|
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Source: Kala Pharmaceuticals, Inc.
MacDougall Biomedical Communications
Cammy Duong, 781-591-3443