Krystal Biotech Announces First Quarter 2023 Financial Results and Operational Highlights
May 08 2023 - 7:23AM
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
first quarter ended March 31, 2023.
“Krystal had a strong start to 2023, marked by significant
progress in commercial preparation activities for our anticipated
FDA approval of B-VEC later this month, as well as advancements
across our pipeline, which lay the groundwork for long-term value
creation,” said Krish S. Krishnan, Chairman and CEO of Krystal
Biotech. He added, “We are also encouraged by the remarkable vision
improvements seen in the RDEB patient who was dosed with B-VEC
topically in the eye to treat cicatrizing conjunctivitis under our
compassionate use program, which supports expansion of our platform
beyond skin and pulmonology into ophthalmological indications.”
Dermatology
B-VEC (beremagene geperpavec) for the treatment of Dystrophic
Epidermolysis Bullosa (DEB)
- In January, the Company was notified by the U.S. Food &
Drug Administration (FDA) that the Prescription Drug User Fee Act
(PDUFA) date for the Company’s Biologics License Application for
B-VEC for the treatment of patients with DEB, will be May 19, 2023.
In April, the Company began labeling discussions with the FDA.
- The Company was informed by the European Medicines Agency in
January 2023 to modify the Pediatric Investigation Plan (PIP)
waiver request to include patients between birth and 6 months. The
Company has modified and submitted the PIP waiver so that the
Marketing Authorization Application procedure can officially start
in the second half of 2023 with an approval expected in early
2024.
- The Company was informed by the Ministry of Health, Labour and
Welfare (MHLW) of Japan that B-VEC was confirmed as safe for
importation under the Cartagena Act. With the approval for the
importation of B-VEC under the Cartagena Act, we intend to start an
open label extension study of B-VEC in Japan in 2023 with an
approval in Japan expected in early 2025.
- In April 2023, the Company presented new data on the
compassionate use of topical B-VEC to treat a patient with RDEB
with recurrent cicatrizing conjunctivitis at the Association for
Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting.
The data presented describes the first application of B-VEC to
treat ocular complications in a patient with RDEB under a
compassionate use program. The patient underwent surgical
symblepharon lysis with pannus removal in the right eye. B-VEC was
administered to the patient’s right eye at regular intervals
following surgery in addition to routine post-surgical management.
B-VEC was well tolerated and associated with full corneal healing
by 3 months as well as significant visual acuity improvement from
hand motion to 20/40 at 7 months, the latest time point of the
ongoing treatment effect evaluation.
Rare dermatological pipeline
- The Company plans to initiate the Phase 2 cohort of its
KB105-02 (JADE-1) trial in the first half of 2023. The Phase 2
cohort will enroll both pediatric and adult patients with TGM1
deficient autosomal recessive congenital ichthyosis for assessment
of KB105 safety and efficacy. Details of the Phase 1/2 study can be
found at www.clinicaltrials.gov under NCT identifier
NCT04047732.
- The Company is working on an investigational new drug (IND)
filing for KB104 for the treatment of Netherton Syndrome. The
Company is on track to file an IND for KB104 in 2023.
Respiratory
KB407 for the treatment of Cystic Fibrosis
- In August 2022, we announced that the FDA had accepted our IND
application to evaluate KB407 in a clinical trial to treat patients
with Cystic Fibrosis. We are closely working with the Therapeutics
Development Network of the Cystic Fibrosis Foundation to validate
our Phase 1 clinical protocol. We plan to initiate a Phase 1
clinical trial in the U.S. in the first half of 2023. Details of
the Phase 1 study can be found at www.clinicaltrials.gov under
NCT identifier NCT05504837.
- Screening activities are ongoing for a Phase 1 clinical trial
in Australia to study safety and determine frequency of dosing
application. Details of the Phase 1 study can be found at
www.clinicaltrials.gov under NCT identifier NCT05095246.
KB408 for the treatment of Alpha-1 Antitrypsin Deficiency
(AATD)
- The Company is performing preclinical and manufacturing
activities and is on track to initiate a Phase 1 clinical trial of
KB408 for the treatment of AATD in the second half of 2023.
Aesthetics
KB301 for the treatment of Aesthetic Indications
- In April, Jeune Aesthetics, Inc. (Jeune), a wholly-owned
subsidiary of the Company, announced the dosing of the first
subject in the Phase 1, Cohort 3 study of KB301 for the improvement
of lateral canthal lines at rest. The Phase 1, Cohort 3 study is
being conducted at a single center as an open label study to assess
two different doses of KB301 in up to 20 subjects. Improvement of
lateral canthal lines at rest was selected as a target indication
for KB301 based upon the Phase 1 safety, efficacy and durability
studies, which evaluated KB301 in the lower and upper cheek,
including the lateral canthal region. Subjects will be followed for
three months after KB301 treatment, and the study is expected to be
complete in the second half of 2023. Details of the Phase 1 study
can be found at www.clinicaltrials.gov under NCT identifier
NCT04540900.
- Jeune plans to initiate a Phase 2 multicenter, double-blind
randomized study (PEARL-2) of KB301 for the improvement of lateral
canthal lines at rest following completion of the Phase 1, Cohort 3
study.
Financial results for the quarter ended
March 31, 2023:
- Cash, cash equivalents, and investments totaled $355.5 million
on March 31, 2023.
- Research and development expenses for the quarter ended
March 31, 2023 were $12.3 million, compared to $9.3 million
for the quarter ended March 31, 2022.
- General and administrative expenses for the quarter ended
March 31, 2023 were $24.0 million, compared to $15.9 million
for the quarter ended March 31, 2022.
- Net losses for the quarters ended March 31, 2023 and 2022
were $45.3 million and $50.0 million, or $(1.76) and $(1.99),
respectively, per common share (basic and diluted).
- For additional information on the Company’s financial results
for the quarter ended March 31, 2023, 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 StatementsAny statements in
this press release about future expectations, plans and prospects
for Krystal Biotech, Inc., including statements about expansion of
our platform beyond skin and pulmonology into ophthalmological
indications, the timing of submission of the European Medicines
Agency’s marketing authorization application for B-VEC and approval
in the EU, our plans to start an open label extension study of
B-VEC in Japan in 2023 with an approval in Japan expected in early
2025, our plans to initiate the Phase 2 cohort of the KB105-02
(JADE-1) trial in the first half of 2023, our plans to file an IND
for KB104 in 2023, the timing of the KB407 Phase 1 clinical trial
program in Australia and the U.S., our plans to initiate a Phase 1
clinical trial of KB408 for the treatment of AATD in the second
half of 2023, our expectation that the Phase 1, Cohort 3 study of
KB301 will be complete in the second half of 2023 and our plans to
initiate 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 DodgeKrystal Biotechmdodge@krystalbio.com
Consolidated Balance Sheet Data:
(In
thousands) |
March 31,2023 |
|
December 31,2022 |
|
Balance sheet data: |
|
|
|
|
Cash and cash equivalents |
$ |
140,745 |
|
$ |
161,900 |
|
Short-term investments |
|
209,642 |
|
|
217,271 |
|
Long-term investments |
|
5,129 |
|
|
4,621 |
|
Total assets |
|
531,847 |
|
|
558,450 |
|
Total liabilities |
|
42,281 |
|
|
36,219 |
|
Total stockholders’ equity |
$ |
489,566 |
|
$ |
522,231 |
|
Consolidated Statement of Operations:
|
Three Months EndedMarch 31, |
|
|
(In thousands, except
shares and per share data) |
|
2023 |
|
|
|
2022 |
|
|
Change |
Expenses |
|
|
|
|
|
Research and development |
$ |
12,288 |
|
|
$ |
9,314 |
|
|
$ |
2,974 |
|
General and administrative |
|
24,035 |
|
|
|
15,908 |
|
|
|
8,127 |
|
Litigation settlement |
|
12,500 |
|
|
|
25,000 |
|
|
|
(12,500 |
) |
Total operating expenses |
|
48,823 |
|
|
|
50,222 |
|
|
|
(1,399 |
) |
Loss from operations |
|
(48,823 |
) |
|
|
(50,222 |
) |
|
|
1,399 |
|
Other Income |
|
|
|
|
|
Interest and other income, net |
|
3,526 |
|
|
|
257 |
|
|
|
3,269 |
|
Net
loss |
$ |
(45,297 |
) |
|
$ |
(49,965 |
) |
|
$ |
4,668 |
|
|
|
|
|
|
|
Net loss per common share:
Basic and diluted |
$ |
(1.76 |
) |
|
$ |
(1.99 |
) |
|
|
|
|
|
|
|
|
Weighted-average common shares
outstanding: Basic and diluted |
|
25,712,220 |
|
|
|
25,114,453 |
|
|
|
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