Kala Pharmaceuticals Reports Second Quarter 2018 Financial Results
– PDUFA Target Action Date for INVELTYS™ is
– Defined Strategy for KPI-121 0.25% in Dry Eye Disease –
– Strengthened Commercial Team in Preparation for INVELTYS Launch –
"Since our last update we have made excellent progress,” said
PDUFA Date for INVELTYS of
Defined Path for KPI-121 0.25% in Dry Eye Disease: Following a
productive meeting with the
- Kala plans to submit a New Drug Application (NDA) during the second half of 2018 including data from one Phase 2 and two Phase 3 efficacy and safety trials.
- In addition, based upon the FDA’s recommendation, Kala has initiated an additional Phase 3 clinical trial, STRIDE 3 (STRIDE - Short Term Relief In Dry Eye), evaluating KPI-121 0.25% for the temporary relief of the signs and symptoms of dry eye disease. Kala believes that the changes made to the design of STRIDE 3 will improve the probability of success. The Company expects to report top-line results for STRIDE 3 in the fourth quarter of 2019.
Second Quarter 2018 Financial Results
Cash Position: As of
June 30, 2018, Kala had cash of $91.2 millioncompared to $114.6 millionas 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
June 30, 2018, research and development expenses were $7.4 millioncompared to $8.1 millionfor the same period in 2017. The decrease in research and development expenses is primarily due to a $1.9 million decrease in external costs associated with the completion of our Phase 3 clinical trials of INVELTYS for the treatment of inflammation and pain following cataract surgery and KPI-121 0.25% for the short-term treatment of dry eye disease. This decrease was offset by a $1.4 million increase in employee-related costs due to the additional hiring of clinical and regulatory personnel, overall merit increases and an increase in stock compensation expense related to stock option grants.
G&A Expenses: For the quarter ended
June 30, 2018, general and administrative expenses were $7.2 millioncompared to $1.6 millionfor the same period in 2017. The increase in general and administrative expenses is attributable to a $2.5 millionincrease in employee-related costs, consisting of a $1.3 millionincrease in general and administrative employee headcount expense and merit increases and a $1.2 millionincrease in stock compensation expenses related to stock options granted during 2018. In addition, the Company incurred a $1.2 millionincrease in costs associated with legal, accounting and finance activities, primarily as a result of operating as a public company, and a $1.9 millionincrease in commercial-related costs as the Company advances its product candidates toward regulatory approval.
Operating Loss: Loss from operations for the quarter ended
June 30, 2018was $14.5 millioncompared to $9.6 millionfor the same period in 2017.
Net Loss: Net loss was
$14.6 million, or $0.60per share, for the quarter ended June 30, 2018, compared to a net loss of $11.0 million, or $9.30per share, for the same period in 2017.
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 preclinical
studies, MPP increased delivery of the active ingredient, loteprednol
etabonate (LE), 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 profile for the treatment of inflammation and
pain following ocular surgery. The NDA for INVELTYS was accepted for
review by the
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 the active ingredient, 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 complement existing therapies, could result in a favorable profile for the management of dry eye flares and other dry eye associated conditions.
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. Kala’s 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, INVELTYS being well-received by physicians and patients
as a twice-daily ocular corticosteroid, the target action date under the
|Kala Pharmaceuticals, Inc.|
|Condensed Consolidated Balance Sheets|
|June 30,||December 31,|
|Total Stockholders’ Equity||68,093||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||Six Months Ended|
|June 30,||June 30,|
|Research and development||$||7,368||$||8,071||$||13,024||$||16,110|
|General and administrative||7,151||1,559||12,633||3,091|
|Total operating expenses||14,519||9,630||25,657||19,201|
|Loss from operations||(14,519||)||(9,630||)||(25,657||)||(19,201||)|
|Other income (expense):|
|Change in fair value of warrant liability||-||(1,185||)||-||(1,221||)|
|Total other income (expense)||(101||)||(1,356||)||(259||)||(1,544||)|
|Net loss per share—basic and diluted||$||(0.60||)||$||(9.30||)||$||(1.06||)||$||(17.56||)|
|Weighted average shares outstanding—basic and diluted||24,567,103||1,181,429||24,554,834||1,181,429|