Full Press Release Details
Krystal Biotech Reports 2019 Financial Results and Business Progress
Phase 3 trial of B-VEC (Beremagene Geperpavec, previously KB103 ) to treat dystrophic
bullosa ( DEB ) to start in 1H 2020
Interim results on Phase 1/2 clinical study on KB105 to be announced in 1H 2020
Planned filing of two Investigational New Drug Applications ( INDs ), one for rare skin disease and
another for an aesthetic skin indication, in 2H 2020
Company strengthens portfolio with four new patents covering B-VEC, KB105 and the STAR-D platform
PITTSBURGH, March 10, 2020 Krystal Biotech Inc., ( Krystal )
(NASDAQ: KRYS), a gene therapy company developing medicines to treat dermatological diseases, announces financial results for 2019 and an update on its business progress.
Krish S. Krishnan, chairman and chief executive officer of Krystal Biotech stated, 2020 is expected to be an exciting year for Krystal as we get ready
to commence the pivotal study of B-VEC, and announce interim Phase 1/2 clinical results on KB105 in the first half of 2020. In January, we hired a chief commercial officer to build out our market access and
commercial team for the anticipated launch of B-VEC and also broke ground on our second cGMP manufacturing facility, ASTRA, a 100,000 square foot facility that will be
built-out and validated over the next 12-15 months to serve our future pipeline products. On the research front, our research, clinical and regulatory teams are working
to initiate a Phase 1 clinical study in an aesthetic skin indication and file an IND for a third rare disease indication in the second half of 2020.
2019 was a busy year for Krystal as we worked to become fully-integrated in the gene therapy space. On the clinical front, we announced positive results
from the Phase 1/2 results of B-VEC to treat DEB and the initiation of a Phase 1/2 clinical study of KB105 for the treatment of TGM1-deficient autosomal recessive congenital ichthyosis ( ARCI ) in
October. On the manufacturing front, we initiated manufacturing of our Phase 3 clinical material at ANCORIS, our first cGMP facility for the clinical and future commercial production of B-VEC, that was completed early in 2020. We strengthened our
patent portfolio with the issuance of our first foreign patent for B-VEC and broadened our platform patent for skin-targeted therapeutics as well as methods of its use for delivering any effector of interest
2019 and Recent Corporate Highlights
Intellectual Property
Financial Results for the Year Ended December 31, 2019
For additional information
on Krystal s financial results for the year ended December 31, 2019, refer to form 10K filed with the SEC.
About Krystal Biotech
Krystal Biotech, Inc. (NASDAQ:KRYS) is a gene therapy company dedicated to developing and commercializing novel treatments for patients
suffering from dermatological diseases. For more information, please visit http://www.krystalbio.com.
B-VEC (Beremagene Geperpavec, previously KB103 ) is Krystal s lead product candidate that seeks
to use gene therapy to treat dystrophic epidermolysis bullosa, or DEB, an incurable skin blistering condition caused by a lack of collagen in the skin. B-VEC is a replication-defective, non-integrating viral vector that has been engineered employing Krystal s STAR-D platform to deliver functional human COL7A1 genes directly to the patients dividing
and non-dividing skin cells. HSV-1 is Krystal s proprietary vector that can penetrate skin cells more efficiently than other viral vectors. Its high
payload capacity allows it to accommodate large or multiple genes and its low immunogenicity makes it a suitable choice for direct and repeat delivery to the skin.
KB105 is Krystal s second
product candidate, currently in preclinical development, and seeks to use gene therapy to treat patients with TGM1-deficient ARCI. KB105 is a replication-defective, non-integrating viral vector that has been
engineered employing Krystal s STAR-D platform to deliver functional human TGM1 gene directly to the patients dividing and non-dividing skin cells. HSV-1 is Krystal s replication-deficient, non-integrating viral vector that can penetrate skin cells more efficiently than other viral vectors. Its high payload capacity
allows it to accommodate large or multiple genes and its low immunogenicity makes it a suitable choice for direct and repeat delivery to the skin.
About the STAR-D Gene Therapy Platform
Krystal s Skin TARgeted Delivery platform, or STAR-D platform, is a proprietary gene therapy
platform consisting of an engineered viral vector and skin-optimized gene transfer technology that Krystal is employing to develop off-the-shelf treatments for
dermatological diseases for which there are no known effective treatments. The company believes that the STAR-D platform provides an optimal approach for treating dermatological conditions due to the nature of
the HSV-1 viral vector it has created. Certain inherent features of the HSV-1 virus, combined with the ability to strategically modify the virus in the form employed as
a gene delivery backbone, provide the STAR-D platform with several advantages over other viral vector platforms for use in dermatological applications.
Forward-Looking Statements
Any statements in this
press release about future expectations, plans and prospects for Krystal, 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 bercolagene telserpavec ( B-VEC ) and KB105, the clinical utility of B-VEC and KB105 and Krystal s plans for filing of regulatory approvals and
efforts to bring B-VEC and KB105 to market, the market opportunity for and the potential market acceptance of B-VEC and KB105, plans to pursue research and development
of other product candidates, the sufficiency of Krystal s existing cash resources 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 and KB105, 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
LifeSci Communications
Source: Krystal Biotech, Inc.