KALA BIO, Inc. (NASDAQ:KALA), a clinical-stage biopharmaceutical
company dedicated to the research, development and
commercialization of innovative therapies for rare and severe
diseases of the eye, today reported financial results for the
second quarter ended June 30, 2024 and provided a corporate update.
"Following the completion of a $12.5 million
private placement financing this quarter, we are entering the
second half of this year well-positioned to advance our lead
candidate, KP1-012, toward a late-stage clinical readout and
explore the broad potential of our MSC-S platform to produce
innovative therapies for rare and severe eye diseases," said Mark
Iwicki, Chair and Chief Executive Officer of KALA BIO. “We are
targeting topline results from the Phase 2b CHASE trial evaluating
KPI-012 for the treatment of Persistent Corneal Epithelial Defect
(PCED) in the first quarter of 2025. If successful, this trial
could serve as the first of two pivotal trials required to support
a BLA submission. We are working diligently to progress the
clinical development of KPI-012, which could be the first treatment
option to address all underlying etiologies of PCED and has the
potential to significantly improve patient outcomes and quality of
life.”
Mr. Iwicki continued, “We believe KPI-012
represents an exciting pipeline-in-a-product opportunity to address
multiple severe corneal diseases by targeting their underlying
causes with a generally well-tolerated and easily administered
therapy. Our clinical progress in PCED will support further
exploration of KPI-012 in additional indications such as Limbal
Stem Cell Deficiency (LSCD) and other corneal diseases. We are also
evaluating our second asset, KPI-014, for the treatment of rare,
inherited retinal diseases including Retinitis Pigmentosa and
Stargardt Disease. We aim to fully realize the potential of our
MSC-S platform technology and establish KALA as a leader in the
emerging field of mesenchymal stem cell secretome therapy.”
Second Quarter and Recent Business
Highlights:
KALA is advancing an innovative pipeline based on
its proprietary mesenchymal stem cell secretome (MSC-S) platform.
KALA believes the multifactorial mechanism of action of its MSC-S
platform technology may enable it to generate product candidates
for a range of ocular orphan diseases and is evaluating the
potential development of this technology for multiple rare, front-
and back-of-the-eye diseases.
KALA’s lead product candidate, KPI-012 contains
growth factors, protease inhibitors, matrix proteins and
neurotrophic factors to potentially correct the impaired corneal
healing that is an underlying etiology of multiple severe ocular
diseases.
KALA is initially developing KPI-012 for the
treatment of PCED, a persistent, non-healing corneal defect or
wound that is refractory to conventional treatments which, if left
untreated, can lead to significant complications, including
infection, corneal perforation/scarring and vision loss. PCED has
an estimated incidence of approximately 100,000 patients in the
U.S., representing a potentially sizeable market opportunity as
there are currently no U.S. Food and Drug Administration
(FDA)-approved prescription products with a broad indication for
all underlying etiologies of PCED.
- KALA continues to enroll patients in the CHASE
(Corneal Healing After SEcretome
therapy) Phase 2b clinical trial evaluating KPI-012 for the
treatment of PCED and plans to report topline data in the first
quarter of 2025. Contingent on positive results and subject to
discussion with regulatory authorities, the Company believes the
CHASE Phase 2b trial could potentially serve as the first of two
pivotal studies required to support the submission of a Biologics
License Application (BLA) to the FDA.
- KALA is also exploring the potential of KPI-012 for additional
rare, front-of-the-eye diseases, including LSCD and other corneal
diseases. LSCD is characterized by the loss or deficiency of limbal
epithelial stem cells, which can result in recurrent epithelial
breakdown, neovascularization, conjunctivalization, inflammation
and other sequalae that can lead to significant symptomology and a
loss of corneal clarity and vision impairment. Like PCED, LSCD
represents a potentially substantial market opportunity, with an
estimated incidence of 100,000 patients in the U.S.
KPI-014, KALA’s preclinical program to evaluate
the utility of its MSC-S platform for inherited retinal
degenerative diseases, contains neurotrophic factors, growth
factors, anti-inflammatory or immune-modulatory factors and
antioxidant inhibitors with the potential to protect and preserve
retinal cell function. Secretomes have demonstrated a
neuroprotective effect in both in vitro and in
vivo models of retinal degeneration. KALA believes KPI-014
could offer a gene-agnostic approach for the treatment of rare
inherited retinal diseases and has initiated preclinical studies to
evaluate the utility of KPI-014 for conditions such as Retinitis
Pigmentosa and Stargardt Disease.
Corporate Updates:
In June 2024, KALA closed a private placement
financing, raising aggregate gross proceeds of $12.5 million. The
financing was led by SR One with participation from ADAR1 Capital
Management and another life sciences-focused investor. In the
private placement, KALA sold an aggregate of 1,197,314 shares of
its common stock at a price of $5.85 per share and 9,393 shares of
its Series H Preferred Stock at a price of $585.00 per share.
Aggregate net proceeds raised in the private placement were $12.3
million.
Financial Results:
Cash Position: As of June 30,
2024, KALA had cash and cash equivalents of $54.2 million, compared
to $48.5 million as of March 31, 2024. This increase reflects gross
proceeds of $12.5 million received from KALA’s June 2024 private
placement financing, partially offset by cash used in operations.
Based on its current plans, KALA anticipates that its cash
resources as of June 30, 2024, together with the $3.2 million of
funds received under the CIRM Award in August 2024 and anticipated
additional funding under the CIRM award, will enable it to fund
operations into the fourth quarter of 2025.
Financial Results for the Three Months
Ended June 30, 2024:
- G&A Expenses: For the quarter ended June
30, 2024, general and administrative (G&A) expenses were $4.3
million, compared to $5.0 million for the same period in 2023. The
decrease was primarily due to a decrease in administrative and
professional service fees.
- R&D Expenses: For the quarter ended June
30, 2024, research and development (R&D) expenses were $5.3
million, compared to $4.3 million for the same period in 2023. The
increase was primarily due to an increase in KPI-012 development
costs and employee-related costs.
- (Gain)/Loss on Fair Value Remeasurement of Contingent
Consideration: For the quarter ended June 30, 2024, the
gain on fair value remeasurement of contingent consideration, in
connection with the acquisition of Combangio, was less than $0.1
million, compared to a loss of $0.4 million for the same period in
2023. The decrease was primarily due to changes in discount rates,
changes in the expected timing and probability of payment and the
passage of time.
- Operating Loss: For the quarter ended June 30,
2024, loss from operations was $9.6 million, compared to $9.6
million for the same period in 2023.
- Net Loss: For the quarter ended June 30, 2024,
net loss was $9.6 million, or $3.16 per share, compared to a net
loss of $10.4 million, or $4.36 per share, for the same period in
2023. The weighted average number of shares used to calculate net
loss per share was 3.0 million for the quarter ended June 30, 2024
and 2.4 million for the quarter ended June 30, 2023.
Financial Results for the Six Months Ended
June 30, 2024:
- G&A Expenses: For the six months ended
June 30, 2024, G&A expenses were $9.7 million, compared to
$11.0 million for the same period in 2023. The decrease was
primarily due to a decrease in administrative and professional
service fees and employee-related costs, partially offset by an
increase in stock-based compensation costs.
- R&D Expenses: For the six months ended
June 30, 2024, R&D expenses were $11.7 million, compared to
$8.3 million for the same period in 2023. The increase was
primarily related to an increase in KPI-012 development costs, as
we advance the clinical development of KPI-012, an increase in
employee-related costs and an increase in other research and
development costs.
- Gain on Fair Value Remeasurement of Deferred Purchase
Consideration: For the six months ended June 30, 2024,
there was no gain on fair value remeasurement of deferred purchase
consideration due to the final settlement of the liability in March
2023. For the six months ended June 30, 2023, the gain on fair
value remeasurement of deferred purchase consideration was $0.2
million.
- Loss on Fair Value Remeasurement of Contingent
Consideration: For the six months ended June 30, 2024, the
loss on fair value remeasurement of contingent consideration, in
connection with the acquisition of Combangio, was $0.1 million,
compared to a loss of $2.2 million for the same period in 2023. The
decrease was primarily due to changes in discount rates, changes in
the expected timing and probability of payment and the passage of
time.
- Operating Loss: For the six months ended June
30, 2024, loss from operations was $21.5 million, compared to a
loss of $21.3 million for the same period in 2023.
- Net Loss: For the six months ended June 30,
2024, net loss was $21.4 million, or $7.32 per share, compared to a
net loss of $24.9 million, or $11.15 per share, for the same period
in 2023. The weighted average number of shares used to calculate
net loss per share was 2.9 million for the six months ended June
30, 2024 and 2.2 million for the six months ended June 30,
2023.
About KALA BIO, Inc.
KALA is a clinical-stage biopharmaceutical company
dedicated to the research, development and commercialization of
innovative therapies for rare and severe 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 and Fast
Track designations from the U.S. Food and Drug Administration. KALA
is also targeting the potential development of KPI-012 for the
treatment of Limbal Stem Cell Deficiency and other rare corneal
diseases that threaten vision and has initiated preclinical studies
to evaluate the potential 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 and its MSC-S platform; the clinical utility
of KPI-012 for PCED; anticipated timelines to report topline data
for the CHASE Phase 2b clinical trial of KPI-012; KALA’s belief
that the Chase Phase 2b trial could serve as the first of two
pivotal trials required to support the submission of a BLA to the
FDA; KALA’s plans to pursue research and development of KPI-012 and
its MSC-S platform for other indications; expectations about the
potential benefits and future operation of the CIRM award; KALA’s
ability to achieve the specified milestones and obtain the full
funding under the CIRM award; the sufficiency of KALA’s existing
cash resources for the period anticipated; and other statements
containing the words “anticipate,” “believe,” “continue,” “could,”
“estimate,” “expect,” “intend,” “likely,” “may,” “plan,”
“potential,” “predict,” “project,” “should,” “target,” “will,”
“would,” 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 comply with the
requirements under the CIRM award; 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 CHASE
Phase 2b clinical trial; whether interim data from a clinical trial
will be predictive of the results of the trial; uncertainties
associated with regulatory review of clinical trials and
applications for marketing approvals; KALA’s ability to retain and
hire key personnel; KALA’s ability to comply with the covenants
under its loan agreement, including the requirement that its common
stock continue to be listed on The Nasdaq Stock Market; the
sufficiency of cash resources and need for additional financing and
other important factors, any of which could cause 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 recent 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.
Financial Tables:
|
KALA BIO,
Inc. Balance Sheet Data (in
thousands) (unaudited) |
|
|
|
|
|
June 30, 2024 |
|
December 31, 2023 |
Cash and cash equivalents |
$ |
54,197 |
|
|
$ |
50,895 |
|
Total
assets |
|
61,606 |
|
|
|
55,949 |
|
Working
capital (1) |
|
39,663 |
|
|
|
44,524 |
|
Current
portion of long-term debt |
|
11,985 |
|
|
|
— |
|
Long-term
debt, net of discounts |
|
22,832 |
|
|
|
34,190 |
|
Other
long-term liabilities |
|
5,867 |
|
|
|
5,909 |
|
Total
stockholders’ equity |
|
13,717 |
|
|
|
7,504 |
|
(1) |
The Company defines working capital as current assets less current
liabilities. See the Company’s consolidated financial statements
for further information regarding its current assets and current
liabilities. |
|
|
KALA BIO, Inc. Consolidated Statement of
Operations (In thousands, except share and per
share data) (Unaudited) |
|
|
|
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
2024 |
|
2023 |
|
2024 |
|
2023 |
Costs and expenses: |
|
|
|
|
|
|
|
General and administrative |
$ |
4,317 |
|
|
$ |
4,962 |
|
|
$ |
9,739 |
|
|
$ |
10,992 |
|
Research and development |
|
5,317 |
|
|
|
4,278 |
|
|
|
11,668 |
|
|
|
8,314 |
|
Gain on fair value remeasurement of deferred purchase
consideration |
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(230 |
) |
(Gain) loss on fair value remeasurement of contingent
consideration |
|
(29 |
) |
|
|
359 |
|
|
|
129 |
|
|
|
2,206 |
|
Total costs and expenses |
|
9,605 |
|
|
|
9,599 |
|
|
|
21,536 |
|
|
|
21,282 |
|
Loss from operations |
|
(9,605 |
) |
|
|
(9,599 |
) |
|
|
(21,536 |
) |
|
|
(21,282 |
) |
Other income (expense): |
|
|
|
|
|
|
|
Interest income |
|
504 |
|
|
|
718 |
|
|
|
1,008 |
|
|
|
1,393 |
|
Interest expense |
|
(1,458 |
) |
|
|
(1,413 |
) |
|
|
(2,913 |
) |
|
|
(2,887 |
) |
Grant income |
|
980 |
|
|
|
— |
|
|
|
2,055 |
|
|
|
— |
|
Other expense, net |
|
— |
|
|
|
(119 |
) |
|
|
— |
|
|
|
(2,092 |
) |
Total other income (expense) |
|
26 |
|
|
|
(814 |
) |
|
|
150 |
|
|
|
(3,586 |
) |
Net loss |
$ |
(9,579 |
) |
|
$ |
(10,413 |
) |
|
$ |
(21,386 |
) |
|
$ |
(24,868 |
) |
Net loss per share attributable to common stockholders—basic and
diluted |
$ |
(3.16 |
) |
|
$ |
(4.36 |
) |
|
$ |
(7.32 |
) |
|
$ |
(11.15 |
) |
Weighted average shares outstanding—basic and diluted |
|
3,030,213 |
|
|
|
2,387,793 |
|
|
|
2,921,712 |
|
|
|
2,229,370 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Investor Contact: Taylor Steiner
taylor.steiner@precisionaq.com 212-362-1200
KALA BIO (NASDAQ:KALA)
過去 株価チャート
から 8 2024 まで 9 2024
KALA BIO (NASDAQ:KALA)
過去 株価チャート
から 9 2023 まで 9 2024