Krystal Biotech Reports Second Quarter 2021 Financial Results and Provides Update on Operational Progress
August 09 2021 - 8:00AM
Krystal Biotech Inc., (“Krystal”) (NASDAQ: KRYS), the leader in
redosable gene therapies for rare diseases, today reported
financial results and key operational progress updates for the
second quarter ending June 30, 2021.
“We are pleased with the progress we have made this quarter on
multiple fronts. Not only has the Krystal team continued to advance
three clinical stage programs including the pivotal GEM-3 trial, we
have also grown the commercial side of our organization and made
significant headway on the construction of our 2nd GMP
manufacturing facility,” said Krish S. Krishnan, Chairman and Chief
Executive Officer of Krystal Biotech, Inc. “The remainder of 2021
promises to be even more exciting as we look forward to reporting
pivotal data on B-VEC, Jeune announcing initial efficacy data for
KB301 in aesthetic skin conditions, and initiating a Phase 1 trial
to evaluate our first pulmonary candidate - KB407 for the treatment
of cystic fibrosis.”
Program Highlights & Upcoming Events:
B-VEC for DEB
- The Company continued to advance the pivotal GEM-3 trial and is
on track to announce top-line data in 4Q21. Details of the pivotal
Phase 3 study can be found at www.clinicaltrials.gov under NCT
identifier NCT04491604.
- During the second quarter the Company began enrolling patients
into an open label extension (“OLE”) study, including patients who
participated in the Phase 3 study and new patients who meet all
enrollment criteria. Details of the OLE study can be found at
www.clinicaltrials.gov under NCT identifier NCT04917874.
KB407 for Cystic Fibrosis
- Following the initial announcement of data from the GLP
toxicology and biodistribution study of repeat doses of KB407 in
nonhuman primates in April 2021, the Company will present more
detailed results from this study in a poster at the North American
Cystic Fibrosis Conference (“NACFC”), taking place September 30 -
October 2.
- The Company is on track to initiate a Phase 1 study of KB407 in
3Q21.
KB105 for TGM1-ARCI
- In July 2021, the Company announced data from the fourth
patient dosed in the Phase 1/2 trial evaluating topical KB105 for
the treatment of TGM1-deficient autosomal recessive congenital
ichthyosis ("TGM1-ARCI"). These data showed that repeat KB105
dosing continued to be well tolerated with no adverse events or
evidence of immune response.
- Krystal plans to discuss these data with patients and key
opinion leaders to help inform next steps. In particular, the
Company will assess the optimal dosing frequency as well as
additional clinical endpoints, including a novel scale designed for
ichthyosis. The Company intends to complete these discussions by
the end of the year and continue dosing in a Phase 2 trial in
2022.
KB301 for Aesthetic Indications
- In August 2021, Jeune Aesthetics, Inc., a wholly-owned
subsidiary of Krystal Biotech Inc., announced the initiation of
dosing in the efficacy cohort of the PEARL-1 (Phase 1) study of
KB301 for aesthetic skin indications. Details of the Phase 1 study
can be found at www.clinicaltrials.gov under NCT identifier
NCT04540900.
- Initial efficacy data from this study is anticipated in
4Q21.
Financial results for the quarter ended June 30,
2021:
- Cash, cash equivalents, and marketable securities totaled
$389.1 million on June 30, 2021, compared to $271.3 million as of
December 31, 2020.
- Research and development expenses for the second quarter ended
June 30, 2021 were $6.6 million, compared to $3.6 million for the
second quarter 2020, and $12.8 million for the six months ended
June 30, 2021, compared to $7.2 million for the six months ended
June 30, 2020.
- General and administrative expenses for the second quarter
ended June 30, 2021 were $9.8 million, compared to $3.3 million for
first quarter 2020, and $18.0 million for the six months ended June
30, 2021, compared to $5.7 million for the six months ended June
30, 2020.
- Net losses for the quarters ended June 30, 2021 and 2020 were
$16.4 million and $6.8 million, or $(0.74) and $(0.37)
respectively, per common share (basic and diluted). Net losses for
the six months ended June 30, 2021 and 2020 were $32.2 million and
$12.2 million or $(1.48) and $(0.68), respectively, per common
share (basic and diluted)
- For additional information on the Company’s financial results
for the second quarter ended June 30, 2021, refer to form 10-Q
filed with the SEC.
About Krystal BiotechKrystal Biotech, Inc.
(NASDAQ:KRYS) is a pivotal-stage gene therapy company leveraging
its novel, redosable gene therapy platform and in-house
manufacturing capabilities to develop therapies to treat serious
rare diseases. For more information please visit
http://www.krystalbio.com.
Forward-Looking StatementsAny statements in
this press release about future expectations, plans and prospects
for Krystal Biotech, Inc., including but not limited to statements
about the development of Krystal’s product candidates, such as
plans for the design, conduct and timelines of ongoing pre-clinical
and clinical trials of beremagene geperpavec (“B-VEC”), KB105,
KB104, KB301, KB407, and KB408; the clinical utility of B-VEC,
KB105, KB104, KB301, KB407 and KB408, and Krystal’s plans for
filing of regulatory approvals and efforts to bring B-VEC, KB105,
KB104, KB301, KB407 and KB408 to market; the market opportunity for
and the potential market acceptance of B-VEC, KB105, KB104, KB301,
KB407 and KB408; plans to pursue research and development of other
product candidates; the sufficiency of Krystal’s existing cash
resources; the unanticipated impact of COVID-19 on Krystal’s
business operations, pre-clinical activities and clinical trials;
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 within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors, including: the
uncertainties inherent in the initiation and conduct of clinical
trials, availability and timing of data from clinical trials,
whether results of early clinical trials or trials will be
indicative of the results of ongoing or future trials,
uncertainties associated with regulatory review of clinical trials
and applications for marketing approvals, the availability or
commercial potential of product candidates including B-VEC, KB105,
KB104, KB301, KB407 and KB408, the sufficiency of cash resources
and need for additional financing and such other important factors
as are set forth under the caption “Risk Factors” in Krystal’s
annual and quarterly reports on file with the U.S. Securities and
Exchange Commission. In addition, the forward-looking statements
included in this press release represent Krystal’s views as of the
date of this release. Krystal anticipates that subsequent events
and developments will cause its views to change. However, while
Krystal may elect to update these forward-looking statements at
some point in the future, it specifically disclaims any obligation
to do so. These forward-looking statements should not be relied
upon as representing Krystal’s views as of any date subsequent to
the date of this release.
CONTACTS: |
|
|
|
Investors: |
Media: |
Whitney Ijem |
Mary Coyle |
Krystal Biotech |
TellMed Strategies |
wijem@krystalbio.com |
mary.coyle@tmstrat.com |
Consolidated Balance Sheet Data:
(In
thousands) |
June 30,2021 |
|
December 31,2020 |
|
Balance sheet data: |
|
|
|
|
Cash and cash equivalents |
$ |
329,527 |
|
|
$ |
268,269 |
|
|
Working capital |
351,808 |
|
|
259,606 |
|
|
Total assets |
443,556 |
|
|
310,844 |
|
|
Total liabilities |
25,016 |
|
|
18,760 |
|
|
Total stockholders’ equity |
$ |
418,540 |
|
|
$ |
292,084 |
|
|
|
|
|
|
|
|
|
|
|
Consolidated Statement of Operations:
|
Three Months Ended June 30, |
|
|
(In thousands, except
shares and per share data) |
2021 |
|
2020 |
|
Change |
Expenses |
|
|
|
|
|
Research and development |
$ |
6,594 |
|
|
$ |
3,639 |
|
|
$ |
2,955 |
|
General and administrative |
9,799 |
|
|
3,315 |
|
|
6,484 |
|
Total operating expenses |
16,393 |
|
|
6,954 |
|
|
9,439 |
|
Loss from operations |
(16,393 |
) |
|
(6,954 |
) |
|
(9,439 |
) |
Other Income
(Expense) |
|
|
|
|
|
Interest and other income, net |
30 |
|
|
121 |
|
|
(91 |
) |
Total other income (expense) |
30 |
|
|
121 |
|
|
(91 |
) |
Net loss |
$ |
(16,363 |
) |
|
$ |
(6,833 |
) |
|
$ |
(9,530 |
) |
|
|
|
|
|
|
Net loss per common share:
Basic and diluted |
$ |
(0.74 |
) |
|
$ |
(0.37 |
) |
|
|
|
|
|
|
|
|
Weighted-average common shares
outstanding: Basic and diluted |
22,204,659 |
|
|
18,383,941 |
|
|
|
|
Six Months Ended June 30, |
|
|
(In thousands, except
shares and per share data) |
2021 |
|
2020 |
|
Change |
Expenses |
|
|
|
|
|
Research and development |
$ |
12,795 |
|
|
$ |
7,164 |
|
|
$ |
5,631 |
|
General and administrative |
17,951 |
|
|
5,735 |
|
|
12,216 |
|
Total operating expenses |
30,746 |
|
|
12,899 |
|
|
17,847 |
|
Loss from operations |
(30,746 |
) |
|
(12,899 |
) |
|
(17,847 |
) |
Other Income
(Expense) |
|
|
|
|
|
Interest and other income, net |
64 |
|
|
725 |
|
|
(661 |
) |
Build to suit interest expense |
(1,492 |
) |
|
— |
|
|
(1,492 |
) |
Total other income (expense) |
(1,428 |
) |
|
725 |
|
|
(2,153 |
) |
Net loss |
$ |
(32,174 |
) |
|
$ |
(12,174 |
) |
|
$ |
(20,000 |
) |
|
|
|
|
|
|
Net loss per common share:
Basic and diluted |
$ |
(1.48 |
) |
|
$ |
(0.68 |
) |
|
|
|
|
|
|
|
|
Weighted-average common shares
outstanding: Basic and diluted |
21,731,711 |
|
|
17,871,648 |
|
|
|
Source: Krystal Biotech, Inc.
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