PDUFA date of May 19, 2023
Presented clinical data at ARVO on topical application of B-VEC to the eye to treat ocular complications in a patient with recessive dystrophic epidermolysis bullosa under Compassionate Use Program
Strong balance sheet, closing the quarter with $355.5 million in cash, cash equivalents and investments
PITTSBURGH, May 08, 2023 (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 first quarter ended March 31, 2023.
“Krystal had a strong start to 2023, marked by significant progress in commercial preparation activities for our anticipated FDA approval of B-VEC later this month, as well as advancements across our pipeline, which lay the groundwork for long-term value creation,” said Krish S. Krishnan, Chairman and CEO of Krystal Biotech. He added, “We are also encouraged by the remarkable vision improvements seen in the RDEB patient who was dosed with B-VEC topically in the eye to treat cicatrizing conjunctivitis under our compassionate use program, which supports expansion of our platform beyond skin and pulmonology into ophthalmological indications.”
Dermatology
B-VEC (beremagene geperpavec) for the treatment of Dystrophic Epidermolysis Bullosa (DEB)
Rare dermatological pipeline
Respiratory
KB407 for the treatment of Cystic Fibrosis
KB408 for the treatment of Alpha-1 Antitrypsin Deficiency (AATD)
Aesthetics
KB301 for the treatment of Aesthetic Indications
Financial results for the quarter ended March 31, 2023:
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 expansion of our platform beyond skin and pulmonology into ophthalmological indications, the timing of submission of the European Medicines Agency’s marketing authorization application for B-VEC and approval in the EU, our plans to start an open label extension study of B-VEC in Japan in 2023 with an approval in Japan expected in early 2025, our plans to initiate the Phase 2 cohort of the KB105-02 (JADE-1) trial in the first half of 2023, our plans to file an IND for KB104 in 2023, the timing of the KB407 Phase 1 clinical trial program in Australia and the U.S., our plans to initiate a Phase 1 clinical trial of KB408 for the treatment of AATD in the second half of 2023, our expectation that the Phase 1, Cohort 3 study of KB301 will be complete in the second half of 2023 and our plans to initiate 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
This email address is being protected from spambots. You need JavaScript enabled to view it.
Consolidated Balance Sheet Data:
(In thousands) | March 31, 2023 | December 31, 2022 | ||||
Balance sheet data: | ||||||
Cash and cash equivalents | $ | 140,745 | $ | 161,900 | ||
Short-term investments | 209,642 | 217,271 | ||||
Long-term investments | 5,129 | 4,621 | ||||
Total assets | 531,847 | 558,450 | ||||
Total liabilities | 42,281 | 36,219 | ||||
Total stockholders’ equity | $ | 489,566 | $ | 522,231 |
Consolidated Statement of Operations:
Three Months Ended March 31, | |||||||||||
(In thousands, except shares and per share data) | 2023 | 2022 | Change | ||||||||
Expenses | |||||||||||
Research and development | $ | 12,288 | $ | 9,314 | $ | 2,974 | |||||
General and administrative | 24,035 | 15,908 | 8,127 | ||||||||
Litigation settlement | 12,500 | 25,000 | (12,500 | ) | |||||||
Total operating expenses | 48,823 | 50,222 | (1,399 | ) | |||||||
Loss from operations | (48,823 | ) | (50,222 | ) | 1,399 | ||||||
Other Income | |||||||||||
Interest and other income, net | 3,526 | 257 | 3,269 | ||||||||
Net loss | $ | (45,297 | ) | $ | (49,965 | ) | $ | 4,668 | |||
Net loss per common share: Basic and diluted | $ | (1.76 | ) | $ | (1.99 | ) | |||||
Weighted-average common shares outstanding: Basic and diluted | 25,712,220 | 25,114,453 |
Last Trade: | US$175.00 |
Daily Change: | -2.11 -1.19 |
Daily Volume: | 190,747 |
Market Cap: | US$5.030B |
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