Krystal Biotech Inc., (“Krystal” or the "Company") (NASDAQ: KRYS),
the leader in redosable gene therapy, today reported financial
results and key operational updates for the fourth quarter and year
ending December 31, 2021.
“I would like to thank the entire Krystal team for their
dedication in 2021. This was an important year for Krystal with the
announcement of positive topline data from the Phase 3 trial of
VyjuvekTM for the treatment of dystrophic epidermolysis bullosa. We
are now working diligently toward global regulatory filings,
including submitting our biologics license application, and
preparing for commercialization,” said Krish S. Krishnan, Chairman
and CEO of Krystal Biotech, Inc. He added, “The positive Phase 3
data provides strong validation of our approach and our platform as
we advance new medicines to treat other debilitating diseases.”
Fourth Quarter Program Highlights & Upcoming
Events:
Vyjuvek for the treatment of Dystrophic Epidermolysis Bullosa
(EB)
- In November 2021, the Company announced positive topline data
from the pivotal GEM-3 trial of topical Vyjuvek (beremagene
geperpavec or B-VEC) for the treatment of dystrophic EB. The
Company intends to present more detailed results at upcoming
medical congresses.
- The Company is on track to file a biologics license application
(BLA) with the U.S. Food and Drug Administration (FDA) in 1H 2022
and a marketing authorization application with the European
Medicines Agency (EMA) in 2H 2022.
KB407 for the treatment of Cystic Fibrosis (CF)
- The Company expects to initiate a Phase 1 clinical trial of
inhaled KB407 in patients with CF in Australia in 1H 2022. Details
of the Phase 1 study can be found at www.clinicaltrials.gov under
NCT identifier NCT05095246.
- The Company plans to expand the Phase 1 trial clinical program
to the U.S. in 2H 2022.
KB105 for the treatment of Autosomal Recessive Congenital
Ichthyosis (ARCI)
- Dosing in the next cohort in the ongoing Phase 2 clinical trial
of KB105 for the treatment of TGM1-deficient ARCI is on track to
resume in 2022.
- Details of the Phase 1/2 study can be found at
www.clinicaltrials.gov under NCT identifier NCT04047732.
KB104 for Netherton Syndrome
- The Company continues to work towards an investigational new
drug filing (IND), which is anticipated in 2022.
KB301 for Aesthetic Indications
- Jeune Aesthetics, Inc., the Company’s wholly-owned subsidiary,
expects to announce safety and proof-of-concept efficacy data from
the Phase 1 study (PEARL-1) of intradermal KB301 in 1Q 2022.
Details of the study can be found at www.clinicaltrials.gov under
NCT identifier NCT04540900.
Corporate Highlights:
- In February 2022, Suma Krishnan was promoted to President,
Research and Development. Suma was the chief architect for the
Company’s differentiated redosable gene therapy platform and has
been leading research and development efforts since Krystal’s
inception. This promotion is a testament to her outstanding
accomplishment in driving the science and innovation leading to
recent positive results from B-VEC, our lead asset from this
platform. With this promotion, Suma will focus on building and
strengthening an industry-leading research and development team and
further expanding the Company’s efforts to deliver life-changing
medicines for patients.
- On December 3, 2021, the Company completed a public offering of
2,866,667 shares of its common stock, including 200,000 shares
purchased by the underwriters, at $75.00 per share. Net proceeds to
the Company from the offering were $201.9 million after deducting
underwriting discounts.
Fourth Quarter and Full Year 2021 Financial
Results:Cash, cash equivalents and investments totaled
$502.5 million on December 31, 2021, compared to
$271.3 million as of December 31, 2020. The increase of
$231.2 million is inclusive of net proceeds from our February 2021
and December 2021 public offerings.
Research and development expenses for the fourth quarter ended
December 31, 2021 were $9.0 million, compared to $5.7 million
for the fourth quarter 2020, and $27.9 million for the year ended
December 31, 2021, compared to $17.9 million for the year
ended December 31, 2020.
General and administrative expenses for the fourth quarter ended
December 31, 2021 were $12.9 million, compared to $4.8 million
for the fourth quarter 2020, and $40.4 million for the year ended
December 31, 2021, compared to $15.1 million for the year
ended December 31, 2020.
Net losses for the quarters ended December 31, 2021 and
2020 were $21.8 million and $10.5 million, or $(0.94) and $(0.53)
respectively, per common share (basic and diluted). Net losses for
the years ended December 31, 2021 and 2020 were $69.6 million
and $32.2 million or $(3.13) and $(1.71) respectively, per common
share (basic and diluted).
For additional information on the Company’s financial results
for the year ended December 31, 2021, refer to form 10-K filed
with the SEC.
About Krystal BiotechKrystal Biotech, Inc.
(NASDAQ:KRYS) is a pivotal-stage gene therapy company leveraging
its proprietary, redosable gene therapy platform and in-house
manufacturing capabilities to potentially bring life-changing
treatment options to patients with serious diseases, including rare
diseases in skin, lung, and other areas.
For more information please visit:https://www.krystalbio.com,
and follow @KrystalBiotech on LinkedIn and Twitter
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 its products; Krystal's plans for filing
regulatory and efforts to bring its products to market; 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, 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:Whitney Ijem Krystal Biotech
wijem@krystalbio.com
Media:Tiffany HamiltonKrystal
Biotechthamilton@krystalbio.com
Consolidated Balance Sheet Data:
(In
thousands) |
December 31,2021 |
|
December 31,2020 |
|
Balance sheet data: |
|
|
|
|
Cash and cash equivalents |
$ |
341,246 |
|
$ |
268,269 |
|
Working capital |
|
416,531 |
|
|
259,606 |
|
Total assets |
|
626,295 |
|
|
310,844 |
|
Total liabilities |
|
32,719 |
|
|
18,760 |
|
Total stockholders’ equity |
$ |
593,576 |
|
$ |
292,084 |
|
Consolidated Statement of Operations:
|
Years Ended December 31, |
|
|
(In thousands, except
shares and per share data) |
|
2021 |
|
|
|
2020 |
|
|
Change |
Expenses |
|
|
|
|
|
Research and development |
$ |
27,884 |
|
|
$ |
17,936 |
|
|
$ |
9,948 |
|
General and administrative |
|
40,391 |
|
|
|
15,063 |
|
|
|
25,328 |
|
Total operating expenses |
|
68,275 |
|
|
|
32,999 |
|
|
|
35,276 |
|
Loss from operations |
|
(68,275 |
) |
|
|
(32,999 |
) |
|
|
(35,276 |
) |
Other Expense |
|
|
|
|
|
Interest and other income, net |
|
197 |
|
|
|
832 |
|
|
|
(635 |
) |
Interest expense |
|
(1,492 |
) |
|
|
— |
|
|
|
(1,492 |
) |
Total interest and other income |
|
(1,295 |
) |
|
|
832 |
|
|
|
(2,127 |
) |
Net
loss applicable to stockholders |
$ |
(69,570 |
) |
|
$ |
(32,167 |
) |
|
$ |
(37,403 |
) |
|
|
|
|
|
|
Net loss attributable to
common stockholders per share: Basic and diluted |
$ |
(3.13 |
) |
|
$ |
(1.71 |
) |
|
|
|
|
|
|
|
|
Weighted-average common
shares outstanding: Basic and diluted |
|
22,196,846 |
|
|
|
18,787,161 |
|
|
|
Source: Krystal Biotech, Inc.
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