• B-VEC PDUFA date May 19, 2023
• Data from the pivotal Phase 3 (GEM-3) trial of B-VEC for dystrophic epidermolysis bullosa published in the New England Journal of Medicine
• Four pipeline clinical trials in dermatology, respiratory and aesthetics to initiate in 2023
• Strong balance sheet, closing the quarter with $383.8 million in cash, cash equivalents and investments
PITTSBURGH, Feb. 27, 2023 (GLOBE NEWSWIRE) -- Krystal Biotech, Inc., (the “Company”) (NASDAQ: KRYS), a biotechnology company focused on developing and commercializing genetic medicines, today reported financial results and key operational updates for the fourth quarter and year ending December 31, 2022.
“In 2022, we were focused on advancing B-VEC toward approval and getting commercially prepared for a potential launch this year, and I thank the entire Krystal team for their dedication and perseverance in helping us achieve our objectives,” said Krish S. Krishnan, Chairman and CEO of Krystal Biotech, Inc. He added, “Our focus in 2023 will be on advancing our pipeline and demonstrating the breadth of our gene delivery platform. We plan to have ASTRA, our second manufacturing facility, operational early this year which will enable us to advance our pipeline products in a timely manner.”
Dermatology
B-VEC (beremagene geperpavec) for Dystrophic Epidermolysis Bullosa (DEB)
Rare Dermatological Pipeline
- The Company plans to file an investigational new drug application (IND) for KB104 for the treatment of Netherton Syndrome in 2023.
Respiratory
KB407 for the treatment of Cystic Fibrosis (CF)
KB408 for the treatment of Alpha-1 Antitrypsin Deficiency (AATD)
- The Company is completing preclinical and manufacturing activities for KB408 and expects to initiate a Phase 1 clinical trial for the treatment of AATD in the second half of 2023.
Aesthetics
KB301 for the treatment of Aesthetic Indications
Fourth Quarter and Full Year 2022 Financial Results:
- Cash, cash equivalents, and investments totaled $383.8 million on December 31, 2022.
- Research and development expenses for the fourth quarter ended December 31, 2022 were $10.7 million, compared to $9.0 million for the fourth quarter 2021, and $42.5 million for the year ended December 31, 2022, compared to $27.9 million for the year ended December 31, 2021.
- General and administrative expenses for the fourth quarter ended December 31, 2022 were $24.0 million, compared to $12.9 million for the fourth quarter 2021, and $77.7 million for the year ended December 31, 2022, compared to $40.4 million for the year ended December 31, 2021.
- Net losses for the quarters ended December 31, 2022 and 2021 were $32.1 million and $21.8 million, or $(1.25) and $(0.94) respectively, per common share (basic and diluted). Net losses for the years ended December 31, 2022 and 2021 were $140.0 million and $69.6 million, or $(5.49) and $(3.13), respectively, per common share (basic and diluted).
- For additional information on the Company’s financial results for the year ended December 31, 2022, please refer to the Form 10-K filed with the Securities and Exchange Commission.
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 B-VEC PDUFA date of May 19, 2023; our focus in 2023 on advancing our pipeline and demonstrating the breadth of our gene delivery platform; our plans to have our second manufacturing facility operational; the timing of the Company’s EMA marketing authorization application for B-VEC; our expectations regarding initiating dosing in the Phase 2 cohort of our KB105-02 (JADE-1) trial; our plans to file an investigational new drug application for KB104; our plan to initiate a Phase 1 dose ranging clinical (CORAL-1) trial for KB407 in the US in the first half of 2023; our plans to initiate a Phase 1 clinical trial for KB408 for the treatment of AATD; our plans for 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
| Condensed Balance Sheet: | ||||||
| (In thousands) | December 31, 2022 | December 31, 2021 | ||||
| Balance sheet data: | ||||||
| Cash and cash equivalents | $ | 161,900 | $ | 341,246 | ||
| Short-term investments | 217,271 | 96,850 | ||||
| Long-term investments | 4,621 | 64,371 | ||||
| Total assets | 558,450 | 626,295 | ||||
| Total liabilities | 36,219 | 32,719 | ||||
| Total stockholders’ equity | $ | 522,231 | $ | 593,576 | ||
| Consolidated Statement of Operations: | |||||||||||
| Three Months Ended December 31, | |||||||||||
| (In thousands, except shares and per share data) | 2022 | 2021 | Change | ||||||||
| Expenses | |||||||||||
| Research and development | $ | 10,741 | $ | 9,010 | $ | 1,731 | |||||
| General and administrative | 24,030 | 12,867 | 11,163 | ||||||||
| Total operating expenses | 34,771 | 21,877 | 12,894 | ||||||||
| Loss from operations | (34,771 | ) | (21,877 | ) | (12,894 | ) | |||||
| Other Income (Expense) | |||||||||||
| Interest and other income, net | 2,719 | 71 | 2,648 | ||||||||
| Net loss | $ | (32,052 | ) | $ | (21,806 | ) | $ | (10,246 | ) | ||
| Net loss per common share: Basic and diluted | $ | (1.25 | ) | $ | (0.94 | ) | |||||
| Weighted-average common shares outstanding: Basic and diluted | 25,680,520 | 23,096,530 | |||||||||
| Years Ended December 31, | |||||||||||
| (In thousands, except shares and per share data) | 2022 | 2021 | Change | ||||||||
| Expenses | |||||||||||
| Research and development | $ | 42,461 | $ | 27,884 | $ | 14,577 | |||||
| General and administrative | 77,735 | 40,391 | 37,344 | ||||||||
| Litigation settlement | 25,000 | — | 25,000 | ||||||||
| Total operating expenses | 145,196 | 68,275 | 76,921 | ||||||||
| Loss from operations | (145,196 | ) | (68,275 | ) | (76,921 | ) | |||||
| Other Income (Expense) | |||||||||||
| Interest and other income, net | 5,221 | 197 | 5,024 | ||||||||
| Interest expense | — | (1,492 | ) | 1,492 | |||||||
| Total other income (expense) | 5,221 | (1,295 | ) | 6,516 | |||||||
| Net loss | $ | (139,975 | ) | $ | (69,570 | ) | $ | (70,405 | ) | ||
| Net loss per common share: Basic and diluted | $ | (5.49 | ) | $ | (3.13 | ) | |||||
| Weighted-average common shares outstanding: Basic and diluted | 25,491,721 | 22,196,846 | |||||||||
