–  Top-line results from the pivotal GEM-3 study of B-VEC in dystrophic epidermolysis bullosa (DEB) on track for 4Q21

–  Enrollment in Phase 1 proof-of-concept study (PEARL-1 study) to treat aesthetic skin conditions is complete

–  Strong balance sheet with September 30, 2021 cash, cash equivalents, and investments of $362.3 million

PITTSBURGH, Nov. 08, 2021 (GLOBE NEWSWIRE) -- 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 third quarter ending September 30, 2021.

“We’ve had a productive third quarter and the momentum continues to build with topline data expected from the pivotal GEM-3 trial evaluating B-VEC this quarter,” said Krish Krishnan, Chairman and CEO of Krystal Biotech, Inc. “If positive, this will be a significant milestone for patients living with DEB and strong validation of our redosable gene therapy platform. Outside of the B-VEC program, we are on track to open enrollment in our Phase 1 study of KB407 for cystic fibrosis in Australia and deliver Phase 1 proof-of-concept efficacy data for KB301 from our wholly-owned subsidiary, Jeune Aesthetics in early 2022. As we continue to advance and grow our pipeline, we are also expanding our manufacturing footprint with continued progress on our second facility – ASTRA – which we expect will come online in 2022.”   

Program Highlights & Upcoming Events:

B-VEC for DEB

KB407 for Cystic Fibrosis

KB105 for TGM1-ARCI

KB301 for Aesthetic Indications

KB104 for Netherton Syndrome

Corporate Highlights:

Financial results for the quarter ended September 30, 2021:

About Krystal Biotech
Krystal 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, and follow @KrystalBiotech on LinkedIn and Twitter.

Forward-Looking Statements
Any 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, and the expected timing for ASTRA coming online; 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:
Julie Normant
Real Chemistry
jnormart@realchemistry.com


Consolidated Balance Sheet Data:

(In thousands)September 30,
2021		 December 31,
2020		 
Balance sheet data:    
Cash and cash equivalents$286,614  $268,269  
Working capital310,033  259,606  
Total assets451,095  310,844  
Total liabilities42,858  18,760  
Total stockholders’ equity$408,237  $292,084  

Consolidated Statement of Operations:

 Three Months Ended September 30,  
(In thousands, except shares and per share data)2021 2020 Change
Expenses     
Research and development$6,080  $5,100  $980 
General and administrative9,572  4,580  4,992 
Total operating expenses15,652  9,680  5,972 
Loss from operations(15,652) (9,680) (5,972)
Other Income (Expense)     
Interest and other income, net63  70  (7)
Total other income (expense)63  70  (7)
Net loss$(15,589) $(9,610) $(5,979)
      
Net loss per common share: Basic and diluted$(0.70) $(0.49)  
      
Weighted-average common shares
   outstanding: Basic and diluted		22,212,266  19,676,016   


 Nine Months Ended September 30,  
(In thousands, except shares and per share data)2021 2020 Change
Expenses     
Research and development$18,875  $12,264  $6,611 
General and administrative27,524  10,315  17,209 
Total operating expenses46,399  22,579  23,820 
Loss from operations(46,399) (22,579) (23,820)
Other Income (Expense)     
Interest and other income, net127  795  (668)
Build to suit interest expense(1,492) —  (1,492)
Total other income (expense)(1,365) 795  (2,160)
Net loss$(47,764) $(21,784) $(25,980)
      
Net loss per common share: Basic and diluted$(2.18) $(1.18)  
      
Weighted-average common shares
   outstanding: Basic and diluted		21,893,656  18,477,495   


Source: Krystal Biotech, Inc.