Item 8.01 Other Events.
On May 12, 2020, Krystal Biotech, Inc., a Delaware corporation (the "Company"),
presented a poster on the in vitro pharmacology of KB407, an HSV-1-based gene
therapy vector, for the treatment of cystic fibrosis at the American Society of
Gene & Cell Therapy Annual Meeting. A copy of the Company's poster is attached
as Exhibit 99.1 hereto and incorporated by reference herein and is also
available at the Company's website located at
www.krystalbio.com/select-scientific-publications.
Any statements in this Current Report on Form 8-K 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 and KB407; the clinical utility of B-VEC, KB105 and
KB407, and Krystal's plans for filing of regulatory approvals and efforts to
bring B-VEC, KB105 and KB407 to market; the market opportunity for and the
potential market acceptance of B-VEC, KB105 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-clinicalactivities 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 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.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
No. Description
99.1 In Vitro Pharmacology of KB407, An HSV-1-Based Gene Therapy Vector, for
the Treatment of Cystic Fibrosis Poster, dated May 12, 2020
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