Krystal Biotech Announces Third Quarter 2022 Financial Results and Operational Highlights
November 07 2022 - 7:00AM
Krystal Biotech, Inc., (the “Company”) (NASDAQ: KRYS), a
biotechnology company focused on developing and commercializing
genetic medicines for patients with rare diseases, today reported
financial results and key operational progress updates for the
third quarter ended September 30, 2022.
“In the third quarter we continued building our commercial
footprint in anticipation of a US and an EU launch in 2023, while
working closely with the FDA during the review cycle,” said Krish
S. Krishnan, Chairman & Chief Executive Officer at Krystal
Biotech. “In the next few months, we intend to initiate dosing in
our KB407, KB105 and KB301 clinical trials where we have commenced
clinical site identification and qualification activities.”
Dermatology
B-VEC (beremagene geperpavec) for Dystrophic Epidermolysis
Bullosa (DEB)
- In October, following mid-cycle BLA review, the Company was
informed that the FDA does not plan on holding an Advisory
Committee meeting and has also not identified a need for Risk
Evaluation and Mitigation Strategies for the B-VEC
application.
- In September, the Company received a positive opinion from the
European Medical Agency (EMA) Pediatric Committee on the Pediatric
Investigation Plan for B-VEC for the treatment of DEB with no
additional studies required. We are on track to submit a Marketing
Authorization Application (MAA) in the fourth quarter of 2022.
- In August, the FDA accepted and granted Priority Review
designation for the B-VEC Biologics License Application (BLA).
Rare dermatological pipeline
- The Company anticipates patient dosing in the ongoing Phase 1/2
clinical trial of KB105 for the treatment of TGM1-deficient
autosomal recessive congenital ichthyosis in early 2023. Details of
the Phase 1/2 study can be found at
www.clinicaltrials.gov under NCT identifier NCT04047732.
- The Company continues to work towards an investigational new
drug filing (IND) for KB104 for the treatment of Netherton
Syndrome, which is now anticipated in the first half of 2023.
Respiratory
KB407 for the treatment of Cystic Fibrosis (CF)
- In August, the Company announced that the U.S. FDA has accepted
the KB407 IND Application to evaluate KB407 for the treatment of
cystic fibrosis in a Phase 1 clinical trial. The Company plans to
initiate the trial in the fourth quarter of 2022.
- The Company continues to screen patients for enrollment in the
Phase 1 clinical study of inhaled KB407 (CORAL-1/AU study) and
plans to initiate dosing in the fourth quarter of 2022. Details of
the Phase 1 study can be found at www.clinicaltrials.gov under
NCT identifier NCT05095246.
Aesthetics
KB301 for the treatment of Aesthetic Indications
- In the second quarter of 2022, following completion of the
PEARL-1 efficacy study, a subset of subjects were rolled over into
a durability trial to evaluate KB301’s duration of effect following
dosing in the Phase 1 efficacy trial. The Company plans on
announcing top line results from the durability trial in the fourth
quarter of 2022. Details of the Phase 1 study can be found at
www.clinicaltrials.gov under NCT identifier NCT04540900.
- The Company intends to start a Phase 2 clinical study (PEARL-2)
for the treatment of wrinkles and improvements in skin quality
attributes in the first half of 2023 following agreement with the
FDA on measurement of primary efficacy endpoints.
Financial results for the quarter ended
September 30, 2022:
- Cash, cash equivalents, and investments totaled $407.0 million
on September 30, 2022.
- Research and development expenses for the quarter ended
September 30, 2022 were $11.5 million, compared to $6.1
million for the quarter ended September 30, 2021 and $31.7
million for the nine months ended September 30, 2022, compared
to $18.9 million for the nine months ended September 30,
2021.
- General and administrative expenses for the quarter ended
September 30, 2022 were $19.9 million, compared to $9.6
million for the quarter ended September 30, 2021 and $53.7
million for the nine months ended September 30, 2022, compared
to $27.5 million for the nine months ended September 30,
2021.
- Net losses for the quarters ended September 30, 2022 and
2021 were $29.9 million and $15.6 million, or $(1.17) and $(0.70),
respectively, per common share (basic and diluted). Net losses for
the nine months ended September 30, 2022 and 2021 were $107.9
million and $47.8 million, or $(4.24) and $(2.18), respectively,
per common share (basic and diluted).
- For additional information on the Company’s financial results
for the quarter ended September 30, 2022, please refer to the
Form 10-Q filed with the SEC.
About Krystal Biotech, Inc.Krystal Biotech,
Inc. (NASDAQ: KRYS) is a biotechnology company focused on
developing and commercializing genetic medicines for patients with
rare diseases. The Company’s wide-ranging pipeline is based on its
proprietary redosable HSV vector. Headquartered in Pittsburgh,
Pennsylvania, the Company is led by an experienced management team,
is fully-integrated and has core capabilities in viral vector
design, vector optimization, gene therapy manufacturing and
commercialization. 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 Statements
Any 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.
CONTACT:Investors and
Media:
Meg Dodge
Krystal Biotech
mdodge@krystalbio.com
Source: Krystal Biotech, Inc.
Consolidated Balance Sheet Data:
(In
thousands) |
September 30,2022 |
|
December 31,2021 |
|
Balance sheet data: |
|
|
|
|
Cash and cash equivalents |
$ |
186,409 |
|
$ |
341,246 |
|
Short-term investments |
|
208,011 |
|
|
96,850 |
|
Long-term investments |
|
12,557 |
|
|
64,371 |
|
Total assets |
|
576,379 |
|
|
626,295 |
|
Total liabilities |
|
35,607 |
|
|
32,719 |
|
Total stockholders’ equity |
$ |
540,772 |
|
$ |
593,576 |
|
|
|
|
|
|
|
|
Consolidated Statement of Operations:
|
Three Months EndedSeptember
30, |
|
|
(In thousands, except
shares and per share data) |
|
2022 |
|
|
|
2021 |
|
|
Change |
Expenses |
|
|
|
|
|
Research and development |
$ |
11,516 |
|
|
$ |
6,080 |
|
|
$ |
5,436 |
|
General and administrative |
|
19,935 |
|
|
|
9,572 |
|
|
|
10,363 |
|
Total operating expenses |
|
31,451 |
|
|
|
15,652 |
|
|
|
15,799 |
|
Loss from operations |
|
(31,451 |
) |
|
|
(15,652 |
) |
|
|
(15,799 |
) |
Other Income
(Expense) |
|
|
|
|
|
Interest and other income, net |
|
1,601 |
|
|
|
63 |
|
|
|
1,538 |
|
Total other income (expense) |
|
1,601 |
|
|
|
63 |
|
|
|
1,538 |
|
Net loss |
$ |
(29,850 |
) |
|
$ |
(15,589 |
) |
|
$ |
(14,261 |
) |
|
|
|
|
|
|
Net loss per common share:
Basic and diluted |
$ |
(1.17 |
) |
|
$ |
(0.70 |
) |
|
|
|
|
|
|
|
|
Weighted-average common
shares outstanding: Basic and diluted |
|
25,619,125 |
|
|
|
22,212,266 |
|
|
|
|
Nine Months Ended September 30, |
|
|
(In thousands, except
shares and per share data) |
|
2022 |
|
|
|
2021 |
|
|
Change |
Expenses |
|
|
|
|
|
Research and development |
$ |
31,720 |
|
|
$ |
18,875 |
|
|
$ |
12,845 |
|
General and administrative |
|
53,705 |
|
|
|
27,524 |
|
|
|
26,181 |
|
Litigation settlement |
|
25,000 |
|
|
|
— |
|
|
|
25,000 |
|
Total operating expenses |
|
110,425 |
|
|
|
46,399 |
|
|
|
64,026 |
|
Loss from operations |
|
(110,425 |
) |
|
|
(46,399 |
) |
|
|
(64,026 |
) |
Other Income
(Expense) |
|
|
|
|
|
Interest and other income, net |
|
2,502 |
|
|
|
127 |
|
|
|
2,375 |
|
Interest expense |
|
— |
|
|
|
(1,492 |
) |
|
|
1,492 |
|
Total other income (expense) |
|
2,502 |
|
|
|
(1,365 |
) |
|
|
3,867 |
|
Net loss |
$ |
(107,923 |
) |
|
$ |
(47,764 |
) |
|
$ |
(60,159 |
) |
|
|
|
|
|
|
Net loss per common share:
Basic and diluted |
$ |
(4.24 |
) |
|
$ |
(2.18 |
) |
|
|
|
|
|
|
|
|
Weighted-average common
shares outstanding: Basic and diluted |
|
25,428,097 |
|
|
|
21,893,656 |
|
|
|
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