Kala Pharmaceuticals Reports First Quarter 2018 Financial Results
"Following the acceptance of our New Drug Application (NDA) by the
Recent Corporate Highlights
Received notification from the
FDAof 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 Trachtenbergas General Counsel and Corporate Secretary. Mr. Trachtenberg formerly served as General Counsel, Chief Compliance Officer and Corporate Secretary of Aralez Pharmaceuticals, Inc. since February 2016.
Presented at the "Spotlight on Dry Eye" session at the Ophthalmology
Innovation Summit at the
American Society of Cataract and Refractive SurgeryAnnual 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 Iwickiwill provide a corporate overview at the Bank of America Merrill Lynch2018 Healthcare Conference on Tuesday, May 15, 2018 and at the Jefferies2018 Global Healthcare Conference on Tuesday, June 5, 2018.
- 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 2017.
- 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 relief.
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 and symptoms.
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
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
Kala Pharmaceuticals, Inc.
|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.
Three Months Ended
|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|
MacDougall Biomedical Communications
Cammy Duong, 781-591-3443