PITTSBURGH, Aug. 08, 2022 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc., (the “Company”) (NASDAQ: KRYS), the leader in redosable gene therapy, today reported financial results and key operational progress updates for the second quarter ending June 30, 2022.

“The B-VEC BLA filing is the first and only FDA filing for the treatment of dystrophic epidermolysis bullosa that fundamentally addresses the underlying genetic pathology of this devastating disease,” said Krish S. Krishnan, Chairman & Chief Executive Officer at Krystal Biotech. “We are committed to driving progress for the DEB patient community, and look forward to the FDA’s review of our filing.” He added, “I am tremendously proud of what the Company has accomplished so far this year, and we anticipate a productive second half of the year as we advance the development of several of our pipeline candidates and prepare for the potential global launch of B-VEC.”   

Program Highlights & Upcoming Events:

B-VEC (beremagene geperpavec) for Dystrophic Epidermolysis Bullosa (DEB)

KB407 for the treatment of Cystic Fibrosis (“CF”)

KB105 for the treatment of Autosomal Recessive Congenital Ichthyosis (ARCI)

KB104 for the treatment of Netherton Syndrome

KB301 for the treatment of Aesthetic Indications

Financial results for the quarter ended June 30, 2022:

About Krystal Biotech, Inc.
Krystal Biotech, Inc. (NASDAQ: KRYS) is a pivotal-stage gene therapy company leveraging its proprietary, redosable gene therapy platform and in-house manufacturing capabilities to develop life-changing medicines for patients with serious diseases, including rare diseases in skin, lung, and other areas. 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 Statements
Any statements in this press release about future expectations, plans and prospects for Krystal Biotech, Inc., including statements about the clinical utility of B-VEC, the timing of the Company’s EMA marketing authorization application for B-VEC, timing of the KB407 Phase 1 clinical trial program in Australia and the U.S., timing of dosing the next cohort in the ongoing Phase 1/2 clinical trial of KB105, timing of an IND filing for KB104, timing of announcement of results from the durability trial of KB301 and the commencement of 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.

CONTACTS:
Investors and Media:                                                               
Meg Dodge                                                     
Krystal Biotech                                                   
mdodge@krystalbio.com                                            

Source: Krystal Biotech, Inc.

Consolidated Balance Sheet Data:

(In thousands)June 30,
2022		 December 31,
2021		 
Balance sheet data:    
Cash and cash equivalents$        218,720 $        341,246 
Short-term investments         206,845          96,850 
Long-term investments         12,902          64,371 
Total assets         601,324          626,295 
Total liabilities         42,143          32,719 
Total stockholders’ equity$        559,181 $        593,576 

Consolidated Statement of Operations:

 Three Months Ended June 30,  
(In thousands, except shares and per share data) 2022   2021  Change
Expenses     
Research and development$        10,890  $        6,594  $        4,296 
General and administrative         17,863           9,799           8,064 
Total operating expenses         28,753           16,393           12,360 
Loss from operations         (28,753)          (16,393)          (12,360)
Other Income (Expense)     
Interest and other income, net         645           30           615 
Total other income (expense)         645           30           615 
Net loss$        (28,108) $        (16,363) $        (11,745)
      
Net loss per common share: Basic and diluted$        (1.10) $        (0.74)  
      
Weighted-average common shares
   outstanding: Basic and diluted		         25,545,167           22,204,659   


 Six Months Ended June 30,  
(In thousands, except shares and per share data) 2022   2021  Change
Expenses     
Research and development$        20,204  $        12,795  $        7,409 
General and administrative         33,771           17,951           15,820 
Litigation settlement         25,000           —           25,000 
Total operating expenses         78,975           30,746           48,229 
Loss from operations         (78,975)          (30,746)          (48,229)
Other Income (Expense)     
Interest and other income, net         902           64           838 
Interest expense         —           (1,492)          1,492 
Total other income (expense)         902           (1,428)          2,330 
Net loss$        (78,073) $        (32,174) $        (45,899)
      
Net loss per common share: Basic and diluted$        (3.08) $        (1.48)  
      
Weighted-average common shares
   outstanding: Basic and diluted		         25,331,000           21,731,711