Krystal Biotech Announces Second Quarter 2022 Financial Results and Reports Updates on Operational Progress
August 08 2022 - 7:00AM
Krystal Biotech, Inc., (the “Company”) (NASDAQ: KRYS), the leader
in redosable gene therapy, today reported financial results and key
operational progress updates for the second quarter ending June 30,
2022.
“The B-VEC BLA filing is the first and only FDA
filing for the treatment of dystrophic epidermolysis bullosa that
fundamentally addresses the underlying genetic pathology of this
devastating disease,” said Krish S. Krishnan, Chairman & Chief
Executive Officer at Krystal Biotech. “We are committed to driving
progress for the DEB patient community, and look forward to the
FDA’s review of our filing.” He added, “I am tremendously proud of
what the Company has accomplished so far this year, and we
anticipate a productive second half of the year as we advance the
development of several of our pipeline candidates and prepare for
the potential global launch of B-VEC.”
Program Highlights & Upcoming
Events:
B-VEC (beremagene geperpavec) for Dystrophic
Epidermolysis Bullosa (DEB)
- Filed and announced a biologics
license application (BLA) with the U.S. Food and Drug
Administration (FDA) on June 22, 2022.
- New data on GEM-3 Phase 3 results for
B-VEC were presented at the Society for Investigative Dermatology
Annual Meeting on May 19, 2022. The full presentation is available
in the Investors section of the Company’s website.
- Marketing Authorization Application
for B-VEC is anticipated to be filed with the European Medical
Agency (EMA) in 2H 2022.
- Published information about the
Company’s HSV-1 based vector platform in Cell & Gene Therapy
Insights discussing the benefits of viral vector-based gene
replacement.
KB407 for the treatment of Cystic Fibrosis
(“CF”)
- FDA accepted IND of KB407 for the
treatment of CF. Anticipate initiating a Phase 1 clinical trial
(CORAL-1/US study) in CF patients in the US in 2H 2022.
- The Company has begun screening
patients for enrollment in the Phase 1 clinical study of inhaled
KB407 (CORAL-1/AU study) and plans to initiate dosing in 2H 2022.
Details of the Phase 1 study can be found at www.clinicaltrials.gov
under NCT identifier NCT05095246.
KB105 for the treatment of Autosomal Recessive
Congenital Ichthyosis (ARCI)
- Dosing the next cohort in the ongoing
Phase 1/2 clinical trial of KB105 for the treatment of
TGM1-deficient ARCI is on track to resume in 2H 2022 and details of
the Phase 1/2 study can be found at www.clinicaltrials.gov under
NCT identifier NCT04047732.
KB104 for the treatment of Netherton Syndrome
- The Company continues to work towards
an investigational new drug filing (IND), which is anticipated
later this year.
KB301 for the treatment of Aesthetic
Indications
- On March 22, 2022, Jeune Aesthetics,
Inc., the Company’s wholly-owned subsidiary, announced positive
proof-of-concept efficacy data with respect to fine lines and
wrinkles in the upper cheek, lower cheek and the knee from Cohort 2
of the PEARL-1 study of KB301. Details of the Phase 1 study can be
found at www.clinicaltrials.gov under NCT identifier
NCT04540900.
- Subjects from Cohort 2 were rolled
over into a durability trial to look for duration of effect
following completion of the PEARL-1 study and for long term safety
monitoring. The Company anticipates announcing results from the
durability trial in Q4 2022.
- The Company anticipates commencing a
Phase 2 study of KB301 in Q4 2022 or Q1 2023.
Financial results for the quarter ended
June 30, 2022:
- Cash, cash equivalents, and
investments totaled $438.5 million on June 30, 2022.
- Research and development expenses for
the quarter ended June 30, 2022 were $10.9 million, compared
to $6.6 million for the quarter ended June 30, 2021 and $20.2
million for the six months ended June 30, 2022, compared to
$12.8 million for the six months ended June 30, 2021.
- General and administrative expenses
for the quarter ended June 30, 2022 were $17.9 million,
compared to $9.8 million for the quarter ended June 30, 2021
and $33.8 million for the six months ended June 30, 2022,
compared to $18.0 million for the six months ended June 30,
2021.
- Net losses for the quarters ended
June 30, 2022 and 2021 were $28.1 million and $16.4 million,
or $(1.10) and $(0.74), respectively, per common share (basic and
diluted). Net losses for the six months ended June 30, 2022
and 2021 were $78.1 million and $32.2 million, or $(3.08) and
$(1.48), respectively, per common share (basic and diluted).
- For additional information on the
Company’s financial results for the quarter ended June 30,
2022, please refer to the Form 10-Q filed with the SEC.
About Krystal Biotech, Inc.Krystal
Biotech, Inc. (NASDAQ: KRYS) is a pivotal-stage gene therapy
company leveraging its proprietary, redosable gene therapy platform
and in-house manufacturing capabilities to develop life-changing
medicines for patients with serious diseases, including rare
diseases in skin, lung, and other areas. For more information,
please visit http://www.krystalbio.com, and follow @KrystalBiotech
on LinkedIn and Twitter.
About Jeune Aesthetics, Inc. Jeune
Aesthetics, Inc., a wholly-owned subsidiary of Krystal Biotech,
Inc., is a biotechnology company leveraging a clinically validated
gene-delivery platform to develop products to fundamentally address
– and reverse – the biology of aging and/or damaged skin. For more
information, please visit http://www.jeuneinc.com.
Forward-Looking StatementsAny
statements in this press release about future expectations, plans
and prospects for Krystal Biotech, Inc., including statements about
the clinical utility of B-VEC, the timing of the Company’s EMA
marketing authorization application for B-VEC, timing of the KB407
Phase 1 clinical trial program in Australia and the U.S., timing of
dosing the next cohort in the ongoing Phase 1/2 clinical trial of
KB105, timing of an IND filing for KB104, timing of announcement of
results from the durability trial of KB301 and the commencement of
a Phase 2 study of KB301, 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: uncertainties associated with regulatory review
of clinical trials and applications for marketing approvals, the
availability or commercial potential of product candidates
including B-VEC, 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 the Company’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 the Company’s views as of the date of
this release. The Company anticipates that subsequent events and
developments will cause its views to change. However, while the
Company 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 the Company’s views as of any date subsequent
to the date of this release.
CONTACTS:Investors and
Media:
Meg Dodge
Krystal Biotech
mdodge@krystalbio.com
Source: Krystal Biotech, Inc.
Consolidated Balance Sheet
Data:
(In thousands) |
June 30,2022 |
|
December 31,2021 |
|
Balance sheet data: |
|
|
|
|
Cash and cash equivalents |
$ |
218,720 |
|
$ |
341,246 |
|
Short-term investments |
|
206,845 |
|
|
96,850 |
|
Long-term investments |
|
12,902 |
|
|
64,371 |
|
Total assets |
|
601,324 |
|
|
626,295 |
|
Total liabilities |
|
42,143 |
|
|
32,719 |
|
Total stockholders’ equity |
$ |
559,181 |
|
$ |
593,576 |
|
Consolidated Statement of
Operations:
|
Three Months Ended June 30, |
|
|
(In thousands, except shares and per share
data) |
|
2022 |
|
|
|
2021 |
|
|
Change |
Expenses |
|
|
|
|
|
Research and development |
$ |
10,890 |
|
|
$ |
6,594 |
|
|
$ |
4,296 |
|
General and administrative |
|
17,863 |
|
|
|
9,799 |
|
|
|
8,064 |
|
Total operating expenses |
|
28,753 |
|
|
|
16,393 |
|
|
|
12,360 |
|
Loss from operations |
|
(28,753 |
) |
|
|
(16,393 |
) |
|
|
(12,360 |
) |
Other Income (Expense) |
|
|
|
|
|
Interest and other income, net |
|
645 |
|
|
|
30 |
|
|
|
615 |
|
Total other income (expense) |
|
645 |
|
|
|
30 |
|
|
|
615 |
|
Net loss |
$ |
(28,108 |
) |
|
$ |
(16,363 |
) |
|
$ |
(11,745 |
) |
|
|
|
|
|
|
Net loss per common share: Basic and diluted |
$ |
(1.10 |
) |
|
$ |
(0.74 |
) |
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding: Basic and
diluted |
|
25,545,167 |
|
|
|
22,204,659 |
|
|
|
|
Six Months Ended June 30, |
|
|
(In thousands, except shares and per share
data) |
|
2022 |
|
|
|
2021 |
|
|
Change |
Expenses |
|
|
|
|
|
Research and development |
$ |
20,204 |
|
|
$ |
12,795 |
|
|
$ |
7,409 |
|
General and administrative |
|
33,771 |
|
|
|
17,951 |
|
|
|
15,820 |
|
Litigation settlement |
|
25,000 |
|
|
|
— |
|
|
|
25,000 |
|
Total operating expenses |
|
78,975 |
|
|
|
30,746 |
|
|
|
48,229 |
|
Loss from operations |
|
(78,975 |
) |
|
|
(30,746 |
) |
|
|
(48,229 |
) |
Other Income (Expense) |
|
|
|
|
|
Interest and other income, net |
|
902 |
|
|
|
64 |
|
|
|
838 |
|
Interest expense |
|
— |
|
|
|
(1,492 |
) |
|
|
1,492 |
|
Total other income (expense) |
|
902 |
|
|
|
(1,428 |
) |
|
|
2,330 |
|
Net loss |
$ |
(78,073 |
) |
|
$ |
(32,174 |
) |
|
$ |
(45,899 |
) |
|
|
|
|
|
|
Net loss per common share: Basic and diluted |
$ |
(3.08 |
) |
|
$ |
(1.48 |
) |
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding: Basic and
diluted |
|
25,331,000 |
|
|
|
21,731,711 |
|
|
|
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