Krystal Biotech Provides Update on Operational Progress and Reports Fourth Quarter and Full Year 2020 Financial Results
March 01 2021 - 8:37AM
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
fourth quarter ending December 31, 2020.
“As the gene therapy landscape evolves, we grow increasingly
confident in the unique positioning of our proprietary technology.
The ability to episomally deliver therapeutic transgenes repeatedly
over time has afforded us a great opportunity to develop
transformative medicines for debilitating rare diseases,” said
Krish Krishnan, Chairman and CEO of Krystal Biotech, Inc. “2021 is
an exciting year for our company as we will have Phase 3 data for
B-VEC, continue to advance our rare skin pipeline, and begin dosing
patients for the first time with our lung targeted vector in cystic
fibrosis.”
Program Highlights & Upcoming Events:
B-VEC for DEB
- Enrollment in the ongoing pivotal GEM-3 study is expected to
complete in 1Q21. Details of the pivotal study can be found at
www.clinicaltrials.gov under NCT identifier NCT04491604
- Top line data is anticipated in 4Q21 followed by BLA filing
shortly after
- Data from this trial will also form the basis of a Marketing
Authorisation Application (MAA) filing in the EU which is
anticipated following the BLA filing
- More details on the safety of repeat dose B-VEC from the
completed Phase 1/2 study will be presented as an e-Poster talk at
the Society of Investigative Dermatology (SID) Annual Meeting,
which will be held May 3-8 as a virtual event-
Title: Assessment of safety in repeat dosing of an in vivo
topical gene therapy for the treatment of recessive dystrophic
epidermolysis bullosa (RDEB) in a phase I/II trial- Session
Name: Poster Session I - Genetic Disease, Gene Regulation,
and Gene Therapy; 2:30pm – 4:00pm EST on May 5th
2021- The presentation will also be available
on-demand for those registered for the SID conference from May 3,
2021 – May 31, 2021
KB105 for TGM1-ARCI
- The Company plans to present an update on this program in 1H21.
The update will consist of safety, TGM1 expression level and
efficacy data from the 4th patient enrolled. Data from this
patient, together with the data from the 3 initial patients will
help determine next steps
- Details of the Phase 1/2 study can be found at
www.clinicaltrials.gov under NCT identifier NCT04047732
KB407 for Cystic Fibrosis
- The GLP toxicology study evaluating repeat dosing of inhaled
KB407 in a large cohort of nonhuman primates is nearly complete,
and the Company plans to announce data from the study in 1H21
- In February 2021 the European Medicines Agency (EMA) Committee
for Orphan Medicinal Products issued a positive opinion on the
Company’s application for orphan drug designation for its
investigational medicine KB407 as a potential treatment for cystic
fibrosis
- Clinical trial initiation is anticipated in 1H21
KB301 for Aesthetic Indications
- Dosing in the first cohort of the Phase 1 study of KB301 is
complete. Patients in cohort 1 received intradermal injections of
KB301 in the buttock region, which was compared to an untreated or
saline injected control. The Company plans to announce initial data
from this cohort, consisting of safety and COL3 expression levels,
in 1Q21 and present more details at the upcoming SID Annual
meeting- Title: First‐in‐human safety and
mechanism of action (MOA) analyses of repeatedly dosed in vivo gene
delivery for directed human type III collagen (COL3) expression in
aesthetics- Session Name: Poster Session I -
Genetic Disease, Gene Regulation, and Gene Therapy; 2:30pm – 4:00pm
EST on May 5th 2021- The presentation will also be
available on-demand for those registered for the SID conference
from May 3, 2021 – May 31, 2021
- Enrollment in the efficacy cohorts is expected to begin in
2H21
KB104 for Netherton Syndrome
- The Company continues to work towards an IND filing, which is
anticipated in 2H21
Fourth Quarter and Full Year 2020 Financial
Results:
- Cash, cash equivalents and short-term investments totaled
$271.3 million on December 31, 2020, compared to $193.7 million as
of December 31, 2019.
- Research and development expenses for the fourth quarter ended
December 31, 2020 were $5.7 million, compared to $4.3 million for
the fourth quarter 2019, and $17.9 million for the year ended
December 31, 2020, compared to $15.6 million for the year ended
December 31, 2019.
- General and administrative expenses for the fourth quarter
ended December 31, 2020 were $4.8 million, compared to $1.8 million
for the fourth quarter 2019, and $15.1 million for the year ended
December 31, 2020, compared to $6.5 million for the year ended
December 31, 2019.
- Net losses for the quarters ended December 31, 2020 and 2019
were $10.5 million and $5.4 million, or $(0.53) and $(0.31)
respectively, per common share (basic and diluted). Net losses for
the years ended December 31, 2020 and 2019 were $32.2 million and
$19.1 million or $(1.71) and $(1.20) respectively, per common share
(basic and diluted).
- For additional information on the Company’s financial results
for the year ended December 31, 2020, refer to form 10-K filed with
the SEC.
Subsequent Events:
- On February 1, 2021, the Company completed a public offering of
2,211,538 shares of its common stock, including 288,461 shares
purchased by the underwriters, at $65.00 per share. Net proceeds to
the Company from the offering were $135.0 million.
- In January 2021, 262,500 shares of common stock were issued
pursuant to our at-the-market equity offering program ("ATM
Program") for net proceeds of $16.9 million, resulting in a
remaining $132.5 million available for issuance under the ATM
Program.
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 clinical
trials of beremagene geperpavec (“B-VEC”), KB105, KB104, KB301 and
KB407; the clinical utility of B-VEC, KB105, KB104, KB301 and
KB407, and Krystal’s plans for filing of regulatory approvals and
efforts to bring B-VEC, KB105, KB104, KB301 and KB407 to market;
the market opportunity for and the potential market acceptance of
B-VEC, KB105, KB104, KB301 and KB407; 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 and KB407, 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) |
December 31,2020 |
|
December 31,2019 |
Balance sheet data: |
|
|
|
Cash and cash equivalents |
$ |
268,269 |
|
|
$ |
187,514 |
|
Working capital |
259,606 |
|
|
192,553 |
|
Total assets |
310,844 |
|
|
209,023 |
|
Total liabilities |
18,760 |
|
|
6,109 |
|
Total stockholders’ equity |
$ |
292,084 |
|
|
$ |
202,914 |
|
|
|
|
|
|
|
|
|
Consolidated Statement of Operations: |
|
|
|
|
|
Years Ended December 31, |
|
|
(In thousands, except
shares and per share data) |
2020 |
|
2019 |
|
Change |
Expenses |
|
|
|
|
|
Research and development |
$ |
17,936 |
|
|
$ |
15,616 |
|
|
$ |
2,320 |
|
General and administrative |
15,063 |
|
|
6,465 |
|
|
8,598 |
|
Total operating expenses |
32,999 |
|
|
22,081 |
|
|
10,918 |
|
Loss from operations |
(32,999 |
) |
|
(22,081 |
) |
|
(10,918 |
) |
Other
Expense |
|
|
|
|
|
Interest and other income, net |
832 |
|
|
2,993 |
|
|
(2,161 |
) |
Total interest and other income |
832 |
|
|
2,993 |
|
|
(2,161 |
) |
Net loss |
(32,167 |
) |
|
(19,088 |
) |
|
(13,079 |
) |
Net loss applicable to
stockholders |
$ |
(32,167 |
) |
|
$ |
(19,088 |
) |
|
$ |
(13,079 |
) |
|
|
|
|
|
|
Net loss attributable to
common stockholders per share: Basic and diluted |
$ |
(1.71 |
) |
|
$ |
(1.20 |
) |
|
|
|
|
|
|
|
|
Weighted-average common
shares outstanding: Basic and diluted |
18,787,161 |
|
|
15,901,083 |
|
|
|
|
|
|
|
|
|
|
|
Source: Krystal Biotech, Inc.
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