Latest News by Industry
• Received US FDA filing acceptance of B-VEC BLA with Priority Review designation for treatment of dystrophic epidermolysis bullosa; PDUFA target action date of February 17, 2023
• Notified of no Advisory Committee meeting or a need for Risk Evaluation and Mitigation Strategies following mid-cycle BLA review for the B-VEC application
• Received positive opinion from EMA Pediatric Committee on the Pediatric Investigation Plan for B-VEC for treatment of dystrophic epidermolysis bullosa; on track to submit a marketing authorization application in fourth quarter of 2022
• Strong balance sheet, closing the quarter with$407.0 millionin cash, cash equivalents and investments
PITTSBURGH, Nov. 07, 2022 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc., (the “Company”) (NASDAQ: KRYS), a biotechnology company focused on developing and commercializing genetic medicines for patients with rare diseases, today reported financial results and key operational progress updates for the third quarter ended September 30, 2022.
“In the third quarter we continued building our commercial footprint in anticipation of a US and an EU launch in 2023, while working closely with the FDA during the review cycle,” said Krish S. Krishnan, Chairman & Chief Executive Officer at Krystal Biotech. “In the next few months, we intend to initiate dosing in our KB407, KB105 and KB301 clinical trials where we have commenced clinical site identification and qualification activities.”
Dermatology
B-VEC (beremagene geperpavec) for Dystrophic Epidermolysis Bullosa (DEB)
Rare dermatological pipeline
Respiratory
KB407 for the treatment of Cystic Fibrosis (CF)
Aesthetics
KB301 for the treatment of Aesthetic Indications
Financial results for the quarter ended September 30, 2022:
About Krystal Biotech, Inc.
Krystal Biotech, Inc. (NASDAQ: KRYS) is a biotechnology company focused on developing and commercializing genetic medicines for patients with rare diseases. The Company’s wide-ranging pipeline is based on its proprietary redosable HSV vector. Headquartered in Pittsburgh, Pennsylvania, the Company is led by an experienced management team, is fully-integrated and has core capabilities in viral vector design, vector optimization, gene therapy manufacturing and commercialization. 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.
CONTACT:
Investors and Media:
Meg Dodge
Krystal Biotech
mdodge@krystalbio.com
Source: Krystal Biotech, Inc.
Consolidated Balance Sheet Data:
| (In thousands) | September 30, 2022 | December 31, 2021 | ||||
| Balance sheet data: | ||||||
| Cash and cash equivalents | $ | 186,409 | $ | 341,246 | ||
| Short-term investments | 208,011 | 96,850 | ||||
| Long-term investments | 12,557 | 64,371 | ||||
| Total assets | 576,379 | 626,295 | ||||
| Total liabilities | 35,607 | 32,719 | ||||
| Total stockholders’ equity | $ | 540,772 | $ | 593,576 | ||
Consolidated Statement of Operations:
| Three Months Ended September 30, | |||||||||||
| (In thousands, except shares and per share data) | 2022 | 2021 | Change | ||||||||
| Expenses | |||||||||||
| Research and development | $ | 11,516 | $ | 6,080 | $ | 5,436 | |||||
| General and administrative | 19,935 | 9,572 | 10,363 | ||||||||
| Total operating expenses | 31,451 | 15,652 | 15,799 | ||||||||
| Loss from operations | (31,451 | ) | (15,652 | ) | (15,799 | ) | |||||
| Other Income (Expense) | |||||||||||
| Interest and other income, net | 1,601 | 63 | 1,538 | ||||||||
| Total other income (expense) | 1,601 | 63 | 1,538 | ||||||||
| Net loss | $ | (29,850 | ) | $ | (15,589 | ) | $ | (14,261 | ) | ||
| Net loss per common share: Basic and diluted | $ | (1.17 | ) | $ | (0.70 | ) | |||||
| Weighted-average common shares outstanding: Basic and diluted | 25,619,125 | 22,212,266 | |||||||||
| Nine Months Ended September 30, | |||||||||||
| (In thousands, except shares and per share data) | 2022 | 2021 | Change | ||||||||
| Expenses | |||||||||||
| Research and development | $ | 31,720 | $ | 18,875 | $ | 12,845 | |||||
| General and administrative | 53,705 | 27,524 | 26,181 | ||||||||
| Litigation settlement | 25,000 | — | 25,000 | ||||||||
| Total operating expenses | 110,425 | 46,399 | 64,026 | ||||||||
| Loss from operations | (110,425 | ) | (46,399 | ) | (64,026 | ) | |||||
| Other Income (Expense) | |||||||||||
| Interest and other income, net | 2,502 | 127 | 2,375 | ||||||||
| Interest expense | — | (1,492 | ) | 1,492 | |||||||
| Total other income (expense) | 2,502 | (1,365 | ) | 3,867 | |||||||
| Net loss | $ | (107,923 | ) | $ | (47,764 | ) | $ | (60,159 | ) | ||
| Net loss per common share: Basic and diluted | $ | (4.24 | ) | $ | (2.18 | ) | |||||
| Weighted-average common shares outstanding: Basic and diluted | 25,428,097 | 21,893,656 | |||||||||