krys-20230519

Delaware

001-38210

82-1080209

(State or other jurisdiction
of incorporation)

(Commission
File Number)

(IRS Employer
Identification Number)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:


☐			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


☐			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

On May 19, 2023, Krystal Biotech, Inc. (the “Company”) issued a press release announcing U.S. Food and Drug Administration (“FDA”) approval of VYJUVEKTM (beremagene geperpavec-svdt) for the treatment of patients six months of age or older with either recessive or dominant Dystrophic Epidermolysis Bullosa. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.

The Company will be hosting an investor conference call and webcast to discuss the FDA approval of VYJUVEK on Friday, May 19, 2023, at 6 pm ET. To register and participate in the conference call, please go to: https://www.netroadshow.com/events/login?show=d32d1c5d&confId=51401. For those unable to listen to the live conference call, a replay will be available on the Investors section of the Company’s website at www.krystalbio.com.

The information contained in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section, or incorporated by reference in any filing with the Securities and Exchange Commission (“SEC”) by the Company under the Exchange Act or the Securities Act of 1933, as amended, whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.

In connection with the FDA approval, the Company is filing certain updated risk factors with this Current Report on Form 8-K for the purpose of supplementing and updating disclosures contained in the Company’s prior filings with the SEC, including those discussed under the heading “Risk Factors,” in the Company’s prospectus supplement filed pursuant to Rule 424(b)(5) under the Securities Act of 1933, as amended, on May 8, 2023 with the SEC. The updated risk factors are filed herewith as Exhibit 99.2 and are incorporated herein by reference.


Exhibit No.						Description

99.1						Press Release, dated May 19, 2023.
99.2						Updated Risk Factors
104						Cover Page Interactive Data file (embedded within the Inline XBRL document)

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Date: May 19, 2023

KRYSTAL BIOTECH, INC.

By:

/s/ Krish S. Krishnan

Name:

Krish S. Krishnan

Title:

Chairman and Chief Executive Officer


☐			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)