Full Press Release Details
Krystal Biotech Reports Third Quarter 2021 Financial Results and Provides Update on Operational Progress
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, November 8, 2021 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.
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:
KB407 for Cystic Fibrosis
KB301 for Aesthetic Indications
KB104 for Netherton Syndrome
Corporate Highlights:
Financial results for the quarter ended September 30, 2021:
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
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.
Consolidated Balance Sheet Data:
| (In thousands) | September 30, 2021 | December 31, 2020 | ||||||
| Balance sheet data: | ||||||||
| Cash and cash equivalents | $ | 286,614 | $ | 268,269 | ||||
| Working capital | 310,033 | 259,606 | ||||||
| Total assets | 451,095 | 310,844 | ||||||
| Total liabilities | 42,858 | 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 administrative | 9,572 | 4,580 | 4,992 | |||||||||
| Total operating expenses | 15,652 | 9,680 | 5,972 | |||||||||
| Loss from operations | (15,652 | ) | (9,680 | ) | (5,972 | ) | ||||||
| Other Income (Expense) | ||||||||||||
| Interest and other income, net | 63 | 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 administrative | 27,524 | 10,315 | 17,209 | |||||||||
| Total operating expenses | 46,399 | 22,579 | 23,820 | |||||||||
| Loss from operations | (46,399 | ) | (22,579 | ) | (23,820 | ) | ||||||
| Other Income (Expense) | ||||||||||||
| Interest and other income, net | 127 | 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.