Grundlæggende statistik
| LEI | 549300YONUY68210OE41 |
| CIK | 1711279 |
SEC Filings
All companies that sell securities in the United States must register with the Securities and Exchange Commission (SEC) and file reports on a regular basis.
These reports include company annual reports (10K, 10Q), news updates (8K), investor presentations (found in 8Ks), insider trades (form 4), ownership reports (13D, and 13G), and reports related to the specific securities sold, such as registration statements and prospectus. This page shows recent SEC filings related to Krystal Biotech, Inc.
SEC Filings (Chronological Order)
Denne side giver en komplet, kronologisk liste over SEC-arkiveringer, eksklusive ejerskabsregistreringer, som vi leverer andre steder.
| May 20, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 OR 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 15, 2026 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File |
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| May 4, 2026 |
Krystal Biotech Announces First Quarter 2026 Financial and Operating Results $116. |
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| May 4, 2026 |
signedemploymentagreemen |
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| May 4, 2026 |
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| May 4, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2026 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38210 Krystal B |
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| May 4, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported) May 4, 2026 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File N |
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| April 3, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☒ Defin |
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| April 3, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Defin |
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| April 3, 2026 |
annualreport-color 2025 Annual Report UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| February 17, 2026 |
Subsidiaries of Krystal Biotech, Inc. Exhibit 21.1 Subsidiaries of Krystal Biotech, Inc. We have omitted the subsidiaries which, considered in the aggregate, would not constitute a “significant subsidiary,” as defined in Rule 1-02(w) of Regulation S-X. |
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| February 17, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of The Securities Exchange Act of 1934 Date of Report (Date of earliest event reported) February 17, 2026 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission |
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| February 17, 2026 |
Krystal Biotech Announces Fourth Quarter and Full Year 2025 Financial and Operating Results $107. |
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| February 17, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-38210 Krystal Biotech, Inc. (Exa |
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| January 12, 2026 |
EXHIBIT 99.1 Krystal Biotech Provides Business Update at 44th Annual J.P. Morgan Healthcare Conference Preliminary 4Q 2025 VYJUVEK net revenue of $106 million to $107 million Robust clinical pipeline with multibillion dollar opportunities and strong balance sheet for sustained growth PITTSBURGH, January 11, 2026 (GLOBE NEWSWIRE) – Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS) today announce |
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| January 12, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 11, 2026 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission |
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| January 8, 2026 |
kb407coral-1cohort3annou © Copyright 2026 Krystal Biotech, Inc. All rights reserved. KB407 for Cystic Fibrosis CORAL-1 Clinical Data Update January 2026 Exhibit 99.2 Krystal | 2 Forward Looking Statements and Disclosures This presentation and our discussion contain forward-looking statements that involve substantial risks and uncertainties. Any statements about future expectations, plans, and pros |
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| January 8, 2026 |
Exhibit 99.1 Krystal Biotech Announces Positive Interim Clinical Update from KB407 Phase 1 CORAL-1 Study with Confirmation of Wild-Type CFTR Delivery to the Lungs of Patients with Cystic Fibrosis Confirmed wild-type CFTR delivery and expression in conducting airway cells of patients with class I mutations KB407 transduction confirmed in all six patients with successful bronchoscopies irrespective |
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| January 8, 2026 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 8, 2026 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission F |
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| December 23, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 23, 2025 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission |
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| November 3, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 3, 2025 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission |
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| November 3, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38210 Kryst |
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| November 3, 2025 |
Krystal Biotech Announces Third Quarter 2025 Financial and Operating Results $97.8 million in 3Q VYJUVEK revenue and $623.2 million since U.S. launch VYJUVEK launched in Germany in 3Q; launched in France and Japan in 4Q Updated U.S. VYJUVEK label expands eligible patient population and provides greater patient flexibility FDA grants platform technology designation CF interim results expected in 4Q |
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| October 22, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): October 22, 2025 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission |
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| August 4, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38210 Krystal Bi |
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| August 4, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 4, 2025 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission Fi |
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| August 4, 2025 |
Krystal Biotech Announces Second Quarter 2025 Financial and Operating Results $96. |
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| July 25, 2025 |
Exhibit 99.1 Krystal Biotech Announces Approval of VYJUVEK® by Japan’s Ministry of Health, Labour and Welfare for the Treatment of Dystrophic Epidermolysis Bullosa VYJUVEK approved for the treatment of DEB from birth with flexible administration options including home dosing and the option for administration by the patient or their family VYJUVEK is the first and only genetic medicine approved in |
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| July 25, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 25, 2025 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission Fil |
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| July 24, 2025 |
Exhibit 99.1 Jeune Announces Positive Results and Significant Aesthetic Improvements from Phase 1 Study of KB304 for Moderate to Severe Wrinkles of the Décolleté KB304 designed to deliver collagen and elastin to restore skin naturally Conference call to discuss results scheduled for Thursday, July 24, 2025 at 4:30pm ET PITTSBURGH, July 24, 2025 - Jeune Aesthetics, Inc. (“Jeune”), a wholly owned su |
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| July 24, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 24, 2025 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission Fil |
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| July 24, 2025 |
irpresentationx7x23x25f July 2025 1 KB304 PEARL-2 Results for Dynamic Wrinkles of the Décolleté r e p l e n i s h r e s t o r e Exhibit 99. |
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| July 9, 2025 |
kb801fpiannouncementfina © Copyright 2025 Krystal Biotech, Inc. All rights reserved. KB801 for Neurotrophic Keratitis First Patient Dosed Update July 2025 Krystal | 2 Forward Looking Statements and Disclosures This presentation and the accompanying oral presentation contain forward-looking statements that involve substantial risks and uncertainties. Any statements about future expectations, plans, |
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| July 9, 2025 |
Exhibit 99.1 Krystal Biotech Announces First Patient Dosed in Phase 1/2 Trial of KB801 for the Treatment of Neurotrophic Keratitis Eye drop administration of KB801 designed to enable sustained expression of NGF in the front of the eye Investor call and webcast to be held July 9 at 8:30 am ET to discuss program and trial design PITTSBURGH, July 9, 2025 (GLOBE NEWSWIRE) – Krystal Biotech, Inc. (the |
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| July 9, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 9, 2025 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File |
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| June 2, 2025 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 2, 2025 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File |
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| June 2, 2025 |
RESULTS ASCO2025 Annual Meeting ABSTRACT #2575 Inhaled KB707, a Novel HSV-based Immunotherapy, as a Monotherapy in Patients with Advanced Solid Tumor Malignancies Affecting the Lungs: Efficacy and Safety Results from a Phase 1/2 Study Wen Wee Ma1, Meredith A. |
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| May 19, 2025 |
Submission of Matters to a Vote of Security Holders UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 19, 2025 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File |
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| May 13, 2025 |
Expansion of an HSV-1-Based Gene Therapy Platform to Treat Hailey-Hailey and Darier Diseases Bruce Nmezi, Ph. |
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| May 13, 2025 |
Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 12, 2025 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File |
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| May 6, 2025 |
Krystal Biotech Announces First Quarter 2025 Financial and Operating Results VYJUVEK approved in Europe for the treatment of DEB patients from birth $88. |
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| May 6, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 6, 2025 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File |
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| May 6, 2025 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 5, 2025 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File |
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| May 6, 2025 |
Topical application of the HSV-1-based gene therapy vector KB801 results in sustained nerve growth factor expression in wounded murine corneas Haley N. |
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| May 6, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38210 Krystal B |
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| April 28, 2025 |
Exhibit 99.1 Krystal Biotech Announces European Commission Approval of VYJUVEK® for the Treatment of Dystrophic Epidermolysis Bullosa VYJUVEK approved for the treatment of DEB from birth in Europe Approval allows for dosing at home or in a healthcare setting, as well as patient or caregiver administration if deemed appropriate by a healthcare professional PITTSBURGH, April 28, 2025 (GLOBE NEWSWIRE |
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| April 28, 2025 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 28, 2025 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission Fi |
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| April 3, 2025 |
2024 Annual Report UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D. |
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| April 3, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☒ Defin |
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| April 3, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Defin |
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| February 28, 2025 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 28, 2025 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission |
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| February 28, 2025 |
Exhibit 99.1 Krystal Biotech Receives Positive CHMP Opinion for VYJUVEK® for the Treatment of Dystrophic Epidermolysis Bullosa EC approval decision anticipated in second quarter of 2025 PITTSBURGH, February 28, 2025 (GLOBE NEWSWIRE) – Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company, today welcomed the European Medicines Agency's (EMA’s) announcement t |
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| February 19, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-38210 Krystal Biotech, Inc. (Exa |
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| February 19, 2025 |
, by and between Wharton Lender Associates, L.P. and Krystal Biotech, Inc. Krystal Biotech September 23, 2024 TWELFTH AMENDMENT TO LEASE AGREEMENT THIS TWELFTH AMENDMENT TO LEASE AGREEMENT (this Twelfth Amendment is made as of the day of September 2024, by and between Wharton Lender Associates, LP, a Pennsylvania limited partnership Landlord Krystal Biotech, Inc. |
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| February 19, 2025 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 19, 2025 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission |
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| February 19, 2025 |
Krystal Biotech Announces Fourth Quarter and Full Year 2024 Financial and Operating Results Fourth quarter revenues increased 116% to $91. |
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| February 19, 2025 |
Subsidiaries of Krystal Biotech, Inc. Exhibit 21.1 Subsidiaries of Krystal Biotech, Inc. We have omitted the subsidiaries which, considered in the aggregate, would not constitute a “significant subsidiary,” as defined in Rule 1-02(w) of Regulation S-X. |
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| February 19, 2025 |
Insider Trading Policy and Guidelines for Disclosure of Material Non-Public Information Exhibit 19.1 KRYSTAL BIOTECH, INC. INSIDER TRADING POLICY AND GUIDELINES FOR DISCLOSURE OF MATERIAL NON-PUBLIC INFORMATION This Insider Trading Policy and Guidelines for Disclosure of Material Non-Public Information (the “Insider Trading Policy”) provides guidelines to all personnel, including employees, directors, officers, and consultants of Krystal Biotech, Inc. (including its subsidiaries and |
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| December 18, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 18, 2024 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission |
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| December 18, 2024 |
Krystal Biotech Announces Early Evidence of Monotherapy Activity in Heavily Pre-Treated Patients with Advanced Non-Small Cell Lung Cancer Preliminary clinical data in post-anti-PD-1 NSCLC patients demonstrated a 27% ORR and 73% DCR in monotherapy trial Monotherapy activity with inhaled KB707 provides further evidence of successful repeat administration of HSV-1 based inhaled lung gene delivery and builds on recent clinical data update for CF and AAT deficiency respiratory disease programs PITTSBURGH, December 18, 2024 (GLOBE NEWSWIRE) – Krystal Biotech, Inc. |
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| December 12, 2024 |
Krystal Biotech Announces Initial Clinical Update for Rare Respiratory Disease Programs KB408 and KB407 Including Early Clinical Evidence of Gene Delivery to the Lung of AATD Patients and Increase in Lung AAT to Therapeutic Levels Clear evidence of SERPINA1 gene delivery and AAT expression following KB408 administration in AATD patients Both KB408 for AATD patients and KB407 for patients with cystic fibrosis were safe and well tolerated at all dosing regimens evaluated to date Conditional sanctioning of the KB407 Phase 1 CF Study CORAL-1 protocol by CFF TDN Investor call and webcast to be held December 12 at 8:30 am ET to discuss data update PITTSBURGH, December 12, 2024 (GLOBE NEWSWIRE) – Krystal Biotech, Inc. |
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| December 12, 2024 |
© Copyright 2024 Krystal Biotech, Inc. All rights reserved. Rare Respiratory Pipeline Interim Clinical Update December 2024 Krystal | 2 Forward Looking Statements and Disclosures Forward Looking Statements This presentation and the accompanying oral presentation that are collectively referred to as this presentation contain forward-looking statements that involve substantial risks and uncertaintie |
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| December 12, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): December 12, 2024 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission |
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| November 14, 2024 |
KRYS / Krystal Biotech, Inc. / Redmile Group, LLC - SC 13G/A Passive Investment SC 13G/A 1 tm2427858d5sc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 5) Krystal Biotech, Inc. (Name of Issuer) Common Stock, $0.00001 par value (Title of Class of Securities) 501147102 (CUSIP Number) September 30, 2024 (Date of Event Which Requires Filing of this Statement) Check the |
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| November 14, 2024 |
EX-99.1 2 tm2427858d5ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Joint Filing Agreement In accordance with Rule 13d-1(k)(1) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the undersigned hereby agree to the joint filing on behalf of each of them of a Statement on Schedule 13G (including any and all amendments thereto, the “Schedule 13G”) relating to the Common Stock, $0.00001 |
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| November 12, 2024 |
KRYS / Krystal Biotech, Inc. / FMR LLC Passive Investment SC 13G/A 1 filing.txt SCHEDULE 13G Amendment No.9 KRYSTAL BIOTECH INC COMMON STOCK Cusip #501147102 Check the appropriate box to designate the rule pursuant to which this Schedule is filed: [x] Rule 13d-1(b) [ ] Rule 13d-1(c) [ ] Rule 13d-1(d) Cusip #501147102 Item 1: Reporting Person - FMR LLC Item 2: (a) [ ] (b) [ ] Item 4: Delaware Item 5: 4,291,926 Item 6: 0 Item 7: 4,292,881 Item 8: 0 Item 9: |
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| November 4, 2024 |
Krystal Biotech Announces Third Quarter 2024 Financial Results and Provides Business Updates Net product revenue of $83. |
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| November 4, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38210 Kryst |
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| November 4, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 4, 2024 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission |
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| October 16, 2024 |
KRYS / Krystal Biotech, Inc. / STATE STREET CORP Passive Investment SC 13G 1 KrystalBiotechInc.htm SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* KRYSTAL BIOTECH INC (Name of Issuer) COMMON STOCK (Title of Class of Securities) 501147102 (CUSIP Number) September 30, 2024 (Date of Event Which Requires Filing of This Statement) Check the appropriate box to designate the rule pursuant |
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| August 28, 2024 |
Jeune Aesthetics Announces Phase 1 Positive Interim Safety and Efficacy Results for KB301 in the Treatment of Lateral Canthal Lines and Dynamic Wrinkles of the Décolleté Décolleté indication selected for Phase 2 study expected to start next year Conference call to discuss results scheduled for Wednesday, August 28, 2024 at 4:30 p. |
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| August 28, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 28, 2024 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission F |
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| August 28, 2024 |
August 2024 1 Revolutionizing Aesthetic Medicine KB301 PEARL-1 Interim Results for Dynamic Wrinkles of the Décolleté and Lateral Canthal Lines Exhibit 99. |
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| August 5, 2024 |
Krystal Biotech, Inc. 2017 IPO S Exhibit 10.2 FIRST AMENDMENT TO THE KRYSTAL BIOTECH, INC. 2017 IPO STOCK INCENTIVE PLAN This First Amendment (the “Amendment”) to the Krystal Biotech, Inc. 2017 IPO Stock Incentive Plan (the “Plan”) is made and entered into effective as of August 2, 2024 (the “Effective Date”). Capitalized terms used but not defined herein shall have the meanings ascribed to such terms in the Plan. RECITALS WHEREA |
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| August 5, 2024 |
Krystal Biotech Announces Second Quarter 2024 Financial Results and Provides Business Updates Net product revenue of $70. |
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| August 5, 2024 |
fective date of August 2, 2024 (incorporated by reference to Exhibit 10.1 to the Company Exhibit 10.1 KRYSTAL BIOTECH, INC. EXECUTIVE CHANGE IN CONTROL SEVERANCE PLAN 1.Purpose. Krystal Biotech, Inc., a Delaware corporation (the “Company”), has adopted the Krystal Biotech, Inc. Executive Change in Control Severance Plan (the “Plan”) to provide severance pay and benefits to Eligible Executives whose employment is terminated under qualifying circumstances during the Change in Control Pr |
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| August 5, 2024 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 5, 2024 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission Fi |
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| August 5, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38210 Krystal Bi |
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| July 10, 2024 |
KRYS / Krystal Biotech, Inc. / VANGUARD GROUP INC - SCHEDULE 13G/A Passive Investment SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Schedule 13G Under the Securities Exchange Act of 1934 (Amendment No.: 1)* Name of issuer: Krystal Biotech Inc Title of Class of Securities: Common Stock CUSIP Number: 501147102 Date of Event Which Requires Filing of this Statement: June 28, 2024 Check the appropriate box to designate the rule pursuant to which this Schedule is filed: ☒ Rul |
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| July 8, 2024 |
KRYS / Krystal Biotech, Inc. / BlackRock Inc. Passive Investment SC 13G/A 1 us5011471027070824.txt us5011471027070824.txt SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No: 4) KRYSTAL BIOTECH INC - (Name of Issuer) Common Stock - (Title of Class of Securities) 501147102 - (CUSIP Number) June 30, 2024 - (Date of Event Which Requires Filing of this Statement) Check the appropriate box to |
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| May 21, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 21, 2024 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File |
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| May 8, 2024 |
An HSV-1-Based Vector Platform for Localized Delivery to the Posterior of the Eye Haley N. |
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| May 8, 2024 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 7, 2024 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File |
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| May 6, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38210 Krystal B |
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| May 6, 2024 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 6, 2024 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File |
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| May 6, 2024 |
Exhibit 99.1 Krystal Biotech Announces First Quarter 2024 Financial Results and Provides Business Updates Net product revenue of $45.3 million in 1Q and $95.9 million since August First patient dosed in inhaled KB707 study for locally advanced or metastatic tumors of the lung Received Fast Track Designations for both inhaled and intratumoral KB707 Strong balance sheet with $622.3 million in cash a |
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| April 4, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☒ Defin |
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| April 4, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☐ Defin |
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| February 26, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-38210 Krystal Biotech |
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| February 26, 2024 |
As filed with the Securities and Exchange Commission on February 26, 2024 As filed with the Securities and Exchange Commission on February 26, 2024 Registration No. |
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| February 26, 2024 |
Executive Incentive Compensation Recoupment Policy Exhibit 97.1 KRYSTAL BIOTECH, INC. EXECUTIVE INCENTIVE COMPENSATION RECOUPMENT POLICY (Adopted August 4, 2023) I.INTRODUCTION The Board of Directors (the “Board”) of Krystal Biotech, Inc. (the “Company”) has determined that it is in the best interests of the Company to adopt a policy (the “Policy”) providing for the Company’s recoupment of “Erroneously Awarded Incentive-Based Compensation” (as def |
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| February 26, 2024 |
Exhibit 99.1 Krystal Biotech Announces Fourth Quarter and Full Year 2023 Financial Results and Provides Business Updates •Net product revenue of $42.1M in 4Q and $50.7M for the year •New England Journal of Medicine publication of the use of B-VEC eyedrop formulation •Reached alignment with FDA to enable approval of B-VEC eyedrop formulation for the treatment of lesions in the eye of DEB patients • |
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| February 26, 2024 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 26, 2024 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission |
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| February 26, 2024 |
Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) Krystal Biotech, Inc. |
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| February 26, 2024 |
Subsidiaries of Krystal Biotech, Inc. Exhibit 21.1 Subsidiaries of Krystal Biotech, Inc. The following subsidiary constitutes a “significant subsidiary,” as defined in Rule 1-02(w) of Regulation S-X. –Krystal Biotech Switzerland GmbH |
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| February 14, 2024 |
KRYS / Krystal Biotech, Inc. / Redmile Group, LLC - SC 13G/A Passive Investment SC 13G/A 1 tm245846d6sc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 4) Krystal Biotech, Inc. (Name of Issuer) Common Stock, $0.00001 par value (Title of Class of Securities) 501147102 (CUSIP Number) December 31, 2023 (Date of Event Which Requires Filing of this Statement) Check the ap |
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| February 14, 2024 |
KRYS / Krystal Biotech, Inc. / Avoro Capital Advisors LLC - KRYSTAL BIOTECH, INC. Passive Investment SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* Krystal Biotech, Inc. (Name of Issuer) Common Stock, par value $0.00001 per share (Title of Class of Securities) 501147102 (CUSIP Number) December 31, 2023 (Date of Event Which Requires Filing of This Statement) Check the appropriate box to designate the rule pursuant |
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| February 14, 2024 |
EX-99.1 2 tm245846d6ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Joint Filing Agreement In accordance with Rule 13d-1(k)(1) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the undersigned hereby agree to the joint filing on behalf of each of them of a Statement on Schedule 13G (including any and all amendments thereto, the “Schedule 13G”) relating to the Common Stock, $0.00001 |
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| February 13, 2024 |
KRYS / Krystal Biotech, Inc. / VANGUARD GROUP INC - SCHEDULE 13G Passive Investment SC 13G 1 tv01302-krystalbiotechinc.htm SCHEDULE 13G SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Schedule 13G Under the Securities Exchange Act of 1934 Name of issuer: Krystal Biotech Inc Title of Class of Securities: Common Stock CUSIP Number: 501147102 Date of Event Which Requires Filing of this Statement: December 29, 2023 Check the appropriate box to designate the rule pursuant to |
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| February 12, 2024 |
KRYS / Krystal Biotech, Inc. / FMR LLC Passive Investment SC 13G/A 1 filing.txt SCHEDULE 13G Amendment No.8 KRYSTAL BIOTECH INC COMMON STOCK Cusip #501147102 Check the appropriate box to designate the rule pursuant to which this Schedule is filed: [x] Rule 13d-1(b) [ ] Rule 13d-1(c) [ ] Rule 13d-1(d) Cusip #501147102 Item 1: Reporting Person - FMR LLC Item 2: (a) [ ] (b) [ ] Item 4: Delaware Item 5: 3,348,551 Item 6: 0 Item 7: 3,349,474 Item 8: 0 Item 9: |
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| February 9, 2024 |
KRYS / Krystal Biotech, Inc. / FMR LLC Passive Investment SC 13G/A 1 filing.txt SCHEDULE 13G Amendment No.7 KRYSTAL BIOTECH INC COMMON STOCK Cusip #501147102 Check the appropriate box to designate the rule pursuant to which this Schedule is filed: [x] Rule 13d-1(b) [ ] Rule 13d-1(c) [ ] Rule 13d-1(d) Cusip #501147102 Item 1: Reporting Person - FMR LLC Item 2: (a) [ ] (b) [ ] Item 4: Delaware Item 5: 2,385,183 Item 6: 0 Item 7: 2,385,898 Item 8: 0 Item 9: |
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| January 29, 2024 |
KRYS / Krystal Biotech, Inc. / BlackRock Inc. Passive Investment SC 13G/A 1 us5011471027012924.txt us5011471027012924.txt SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No: 3) KRYSTAL BIOTECH INC - (Name of Issuer) Common Stock - (Title of Class of Securities) 501147102 - (CUSIP Number) December 31, 2023 - (Date of Event Which Requires Filing of this Statement) Check the appropriate bo |
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| November 6, 2023 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 6, 2023 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission |
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| November 6, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38210 Kryst |
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| November 6, 2023 |
Exhibit 99.1 Krystal Biotech Announces Third Quarter 2023 Financial Results and Provides Business Update •284 VYJUVEK Patient Start Forms and $8.6 million in VYJUVEK U.S. net product revenue as of the end of the third quarter • Cohort 1 completed in Phase 1 clinical trial of KB407 for the treatment of CF •First patient dosed in Phase 1 Clinical Trial of KB707 in patients with locally advanced or m |
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| August 7, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38210 Krystal Bi |
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| August 7, 2023 |
Exhibit 99.1 Krystal Biotech Announces Second Quarter 2023 Financial Results and Operational Highlights •VYJUVEK™ approved in the U.S. as the first and only topical redosable gene therapy for the treatment of dystrophic epidermolysis bullosa •121 Patient Start Forms in the first six weeks of launch •First cystic fibrosis patient dosed in Phase 1 Clinical Trial of KB407 •IND for KB707, Krystal’s fi |
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| August 7, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 7, 2023 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission Fi |
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| August 7, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 2, 2023 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission Fi |
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| July 26, 2023 |
exhibit992investorslidep © Copyright 2023 Krystal Biotech, Inc. All rights reserved. Research & Development Oncology Program Announcement July 2023 Krystal | 2 Speakers Suma Krishnan President, Research & Development Trevor Parry, PhD VP, Research and Scientific Affairs David Chien, MD SVP, Clinical Development – Oncology Jason J. Luke, MD, FACP • Associate Professor of Medicine in the Division of |
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| July 26, 2023 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 26, 2023 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission Fil |
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| July 26, 2023 |
Exhibit 99.1 Krystal Biotech Announces Pipeline Expansion into Oncology and FDA Acceptance of IND Application for Lead Oncology Candidate KB707 PITTSBURGH, July 26, 2023 (GLOBE NEWSWIRE) – Krystal Biotech, Inc. (the “Company”) (NASDAQ: KRYS), a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet m |
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| July 18, 2023 |
Power of Attorney (included on signature page hereto). S-3ASR Table of Contents As filed with the Securities and Exchange Commission on July 18, 2023 Registration No. |
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| July 18, 2023 |
EX-FILING FEES Exhibit 107 Calculation of Filing Fee Table Form S-3 (Form Type) Krystal Biotech, Inc. |
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| May 23, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 23, 2023 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File |
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| May 22, 2023 |
Exhibit 10.1 SECURITIES PURCHASE AGREEMENT This SECURITIES PURCHASE AGREEMENT (this “Agreement”) is made and entered into as of May 21, 2023, by and among Krystal Biotech, Inc., a Delaware corporation (the “Company”), and the Investors identified on Exhibit A attached hereto (each an “Investor” and collectively the “Investors”). RECITALS A. The Company and the Investors are executing and deliverin |
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| May 22, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 22, 2023 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File |
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| May 22, 2023 |
Krystal Biotech Announces $160 Million Private Placement Equity Financing Exhibit 99.1 Krystal Biotech Announces $160 Million Private Placement Equity Financing PITTSBURGH, May 22, 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 announced that it has entered into a securities purchase agreement for the sale of 1,729,729 s |
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| May 22, 2023 |
Exhibit 10.2 REGISTRATION RIGHTS AGREEMENT This REGISTRATION RIGHTS AGREEMENT (this “Agreement”) is made and entered into as of May 21, 2023, by and among Krystal Biotech Inc., a Delaware corporation (the “Company”), and the “Investors” named in that certain Securities Purchase Agreement by and among the Company and the Investors, dated as of May 21, 2023 (the “Purchase Agreement”). Capitalized te |
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| May 19, 2023 |
Exhibit 99.1 Krystal Biotech Receives FDA Approval for the First-Ever Redosable Gene Therapy, VYJUVEKTM (beremagene geperpavec-svdt) for the Treatment of Dystrophic Epidermolysis Bullosa •Dystrophic Epidermolysis Bullosa (DEB) is a serious rare genetic disease that affects the skin and mucosal tissues and is caused by one or more mutations in the COL7A1 gene, resulting in lack of production of fun |
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| May 19, 2023 |
Exhibit 99.2 Updated Risk Factors Risks Related to Our Business We have limited experience as a commercial company and the sales, marketing, and distribution of VYJUVEK or any future approved products may be unsuccessful or less successful than anticipated. We recently received FDA approval of VYJUVEK, and we have initiated a commercial launch of VYJUVEK in the United States. As a company, we have |
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| May 19, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 19, 2023 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File |
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| May 11, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 11, 2023 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File |
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| May 11, 2023 |
isid2023-finalposterpdf Long term use of topical beremagene geperpavec (B-VEC) in two patients with dystrophic epidermolysis bullosa N Momin1, IS Bagci1, B Agostini2, H Chen2, G Feeney2, M Steimer2, K Sridhar1, B Kapadia2, S Krishnan2, MP Marinkovich1 1Stanford University, Stanford, CA; 2Krystal Biotech, Inc. |
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| May 10, 2023 |
KRYS / Krystal Biotech Inc / FMR LLC Passive Investment SCHEDULE 13G Amendment No.6 KRYSTAL BIOTECH INC COMMON STOCK Cusip #501147102 Check the appropriate box to designate the rule pursuant to which this Schedule is filed: [x] Rule 13d-1(b) [ ] Rule 13d-1(c) [ ] Rule 13d-1(d) Cusip #501147102 Item 1: Reporting Person - FMR LLC Item 2: (a) [ ] (b) [ ] Item 4: Delaware Item 5: 2,613,035 Item 6: 0 Item 7: 2,613,272 Item 8: 0 Item 9: 2,613,272 Item 11: 10 |
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| May 8, 2023 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 8, 2023 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File |
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| May 8, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38210 Krystal B |
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| May 8, 2023 |
Sales Agreement, dated May 8, 2023, by and between Krystal Biotech, Inc. and Cowen and Company, LLC. EX-1.1 EXHIBIT 1.1 KRYSTAL BIOTECH, INC. Common Stock (par value $0.00001 per share) SALES AGREEMENT May 8, 2023 Cowen and Company, LLC 599 Lexington Avenue New York, NY 10022 Ladies and Gentlemen: Krystal Biotech, Inc., a Delaware corporation (the “Company”), confirms its agreement (this “Agreement”) with Cowen and Company, LLC (“Cowen”), as follows: 1. Issuance and Sale of Shares. The Company ag |
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| May 8, 2023 |
424B5 Table of Contents Filed Pursuant to Rule 424(b)(5) Registration No. 333-271167 PROSPECTUS SUPPLEMENT (To prospectus dated April 6, 2023) $150,000,000 Common Stock We have entered into a sales agreement with Cowen and Company, LLC, or Cowen, relating to the shares of our common stock offered by this prospectus supplement and the accompanying prospectus. In accordance with the terms of the sal |
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| May 8, 2023 |
Krystal Biotech Announces First Quarter 2023 Financial Results and Operational Highlights •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. |
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| May 8, 2023 |
EX-FILING FEES Exhibit 107 Calculation of Filing Fee Tables 424(b)(5) (Form Type) Krystal Biotech, Inc. |
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| May 8, 2023 |
Form of Time-Based Restricted Stock Unit Award Agreement under the 2017 IPO Stock Incentive Plan Exhibit 10.1 KRYSTAL BIOTECH, INC. 2017 IPO STOCK INCENTIVE PLAN NOTICE OF RESTRICTED STOCK UNIT AWARD Grantee’s Name and Address: You (the “Grantee”) have been granted an award of Restricted Stock Units (the “RSUs”), subject to the terms and conditions of this Notice of Restricted Stock Unit Award (the “Notice”), the Krystal Biotech, Inc. 2017 IPO Stock Incentive Plan, as amended from time to tim |
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| May 8, 2023 |
Exhibit 10.2 KRYSTAL BIOTECH, INC. 2017 IPO STOCK INCENTIVE PLAN NOTICE OF PERFORMANCE-BASED RESTRICTED STOCK UNIT AWARD Grantee’s Name and Address: You (the “Grantee”) have been granted an award of performance-based Restricted Stock Units (the “RSUs”), subject to the terms and conditions of this Notice of Performance-Based Restricted Stock Unit Award (the “Notice”), the Krystal Biotech, Inc. 2017 |
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| May 8, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 8, 2023 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File |
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| April 24, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): April 23, 2023 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission Fi |
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| April 24, 2023 |
Exhibit 99.1 Krystal Biotech Announces Clinical Data on Topical Application of B-VEC to the Eye to Treat Ocular Complications in a Patient with Dystrophic Epidermolysis Bullosa Under a Compassionate Use Program •Data presented at Association for Research in Vision and Ophthalmology Annual Meeting on April 23, 2023 •Topical application of B-VEC to the eye was well tolerated and patient showed signi |
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| April 24, 2023 |
United States securities and exchange commission logo April 24, 2023 Kathryn A. Romano Chief Accounting Officer Krystal Biotech, Inc. 2100 Wharton Street, Suite 701 Pittsburgh, PA 15203 Re: Krystal Biotech, Inc. Form 10-K for the Fiscal Year Ended December 31, 2022 Filed Feberuary 27, 2023 File No. 001-38210 Dear Kathryn A. Romano: We have completed our review of your filings. We remind you that t |
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| April 24, 2023 |
Exhibit 99.2 |
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| April 11, 2023 |
April 11, 2023 U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, N.E. Washington, DC 20549 Attn: Gary Newberry Kevin J. Kuhar Re: Krystal Biotech, Inc. Form 10-K for the fiscal year ended December 31, 2022 Filed February 27, 2023 File No. 001-38210 Dear Messrs. Newberry and Kuhar: This letter provides the response of Krystal Biotech, Inc. |
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| April 6, 2023 |
Exhibit 107 Calculation of Filing Fee Tables Form S-3 (Form Type) Krystal Biotech, Inc. |
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| April 6, 2023 |
As filed with the Securities and Exchange Commission on April 6, 2023 As filed with the Securities and Exchange Commission on April 6, 2023 Registration No. |
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| April 4, 2023 |
DEFA14A 1 noticeofinternetavailabili.htm DEFA14A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commissio |
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| April 4, 2023 |
Definitive Proxy Statement on Schedule 14A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ☒ Defin |
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| March 30, 2023 |
United States securities and exchange commission logo March 30, 2023 Kathryn A. Romano Chief Accounting Officer Krystal Biotech, Inc. 2100 Wharton Street, Suite 701 Pittsburgh, PA 15203 Re: Krystal Biotech, Inc. Form 10-K for the Fiscal Year Ended December 31, 2022 Filed Feberuary 27, 2023 File No. 001-38210 Dear Kathryn A. Romano: We have reviewed your filing and have the following comment. In so |
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| March 6, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 6, 2023 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission Fil |
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| March 6, 2023 |
Krystal Biotech Appoints Catherine Mazzacco to Board of Directors Exhibit 99.1 Krystal Biotech Appoints Catherine Mazzacco to Board of Directors March 6, 2023 PITTSBURGH, March 6, 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 announced the appointment of Catherine Mazzacco to its Board of Directors. “I am pleas |
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| February 27, 2023 |
Form of Krystal Biotech, Inc. 2017 IPO Stock Incentive Plan Notice of Exhibit 10.23 KRYSTAL BIOTECH, INC. 2017 IPO STOCK INCENTIVE PLAN NOTICE OF RESTRICTED STOCK BONUS AWARD Grantee’s Name and Address: You (the “Grantee”) have been granted shares of Common Stock of the Company (the “Award”), subject to the terms and conditions of this Notice of Restricted Stock Bonus Award (the “Notice”), the Krystal Biotech, Inc. 2017 IPO Stock Incentive Plan, as amended from time |
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| February 27, 2023 |
Exhibit 4.3 DESCRIPTION OF COMMON STOCK General Our authorized capital stock consists of 80,000,000 shares of common stock, $0.00001 par value per share, and 20,000,000 shares of preferred stock, $0.00001 par value per share. Our common stock is registered under Section 12(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). We have no other securities registered under Secti |
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| February 27, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-38210 Krystal Biotech |
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| February 27, 2023 |
Subsidiaries of Krystal Biotech, Inc. Exhibit 21.1 Subsidiaries of Krystal Biotech, Inc. We have omitted the subsidiaries which, considered in the aggregate, would not constitute a “significant subsidiary,” as defined in Rule 1-02(w) of Regulation S-X. |
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| February 27, 2023 |
Exhibit 99.1 Krystal Biotech Announces Fourth Quarter and Full Year 2022 Financial Results and Operational Progress February 27, 2023 •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 • |
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| February 27, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 27, 2023 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission |
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| February 14, 2023 |
EX-99.1 2 tm236041d14ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Joint Filing Agreement In accordance with Rule 13d-1(k)(1) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), the undersigned hereby agree to the joint filing on behalf of each of them of a Statement on Schedule 13G (including any and all amendments thereto, the “Schedule 13G”) relating to the Common Stock, $0.00001 |
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| February 14, 2023 |
KRYS / Krystal Biotech Inc / Avoro Capital Advisors LLC - KRYSTAL BIOTECH, INC. Passive Investment SC 13G 1 p23-0580sc13g.htm KRYSTAL BIOTECH, INC. SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. )* Krystal Biotech, Inc. (Name of Issuer) Common Stock, par value $0.00001 per share (Title of Class of Securities) 501147102 (CUSIP Number) December 31, 2022 (Date of Event Which Requires Filing of This Statement) Check th |
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| February 14, 2023 |
KRYS / Krystal Biotech Inc / Redmile Group, LLC - SC 13G/A Passive Investment SC 13G/A 1 tm236041d14sc13ga.htm SC 13G/A UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 3) Krystal Biotech, Inc. (Name of Issuer) Common Stock, $0.00001 par value (Title of Class of Securities) 501147102 (CUSIP Number) December 31, 2022 (Date of Event Which Requires Filing of this Statement) Check the a |
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| February 14, 2023 |
SC 13G/A 1 pt7213ga.htm SCHEDULE 13G/A, AMENDMENT #2 240.13d-102 Schedule 13G - Information to be included in statements filed pursuant to 240.13d-1(b), (c), and (d) and amendments thereto filed pursuant to 240.13d-2. Securities and Exchange Commission, Washington, D.C. 20549 Schedule 13G Under the Securities Exchange Act of 1934 (Amendment No. 2)* (Name of Issuer) Krystal Biotech, Inc. (Title of |
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| February 9, 2023 |
KRYS / Krystal Biotech Inc / FMR LLC Passive Investment SC 13G/A 1 filing.txt SCHEDULE 13G Amendment No.5 KRYSTAL BIOTECH INC COMMON STOCK Cusip #501147102 Check the appropriate box to designate the rule pursuant to which this Schedule is filed: [x] Rule 13d-1(b) [ ] Rule 13d-1(c) [ ] Rule 13d-1(d) Cusip #501147102 Item 1: Reporting Person - FMR LLC Item 2: (a) [ ] (b) [ ] Item 4: Delaware Item 5: 2,108,661 Item 6: 0 Item 7: 2,108,853 Item 8: 0 Item 9: |
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| February 2, 2023 |
Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) Krystal Biotech, Inc. |
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| February 2, 2023 |
As filed with the Securities and Exchange Commission on February 2, 2023 As filed with the Securities and Exchange Commission on February 2, 2023 Registration No. |
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| February 1, 2023 |
KRYS / Krystal Biotech Inc / BlackRock Inc. Passive Investment SC 13G/A 1 us5011471027013123.txt us5011471027013123.txt SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No: 2) KRYSTAL BIOTECH INC - (Name of Issuer) Common Stock - (Title of Class of Securities) 501147102 - (CUSIP Number) December 31, 2022 - (Date of Event Which Requires Filing of this Statement) Check the appropriate bo |
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| January 9, 2023 |
Krystal Biotech Announces FDA’s 3-Month Extension of BLA PDUFA Date and Regulatory Update for B-VEC to Treat Patients with Dystrophic Epidermolysis Bullosa January 9, 2023 NEW PDUFA DATE OF MAY 19, 2023 PITTSBURGH, January 9, 2023 (GLOBE NEWSWIRE) – Krystal Biotech, Inc. |
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| January 9, 2023 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 9, 2023 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission F |
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| November 17, 2022 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 17, 2022 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission |
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| November 17, 2022 |
Jeune Aesthetics Announces Positive Durability Results for KB301 in the PEARL-1 Extension Cohort, an Investigational Gene-based Treatment for Improvement of Fine Lines and Wrinkles November 17, 2022 ? Up to nine months durability of effect observed in patients aged 55 to 76 in the extension cohort following administration of high dose KB301 ? Mean change in Subject Satisfaction Scores from baseline ranged from 1. |
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| November 17, 2022 |
A GENE-BASED AESTHETICS COMPANY November 2022 1 PEARL-1 Durability Results Forward Looking Statement 2 This presentation contains forward-looking statements that involve substantial risks and uncertainties. |
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| November 7, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38210 Kryst |
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| November 7, 2022 |
Exhibit 99.1 Krystal Biotech Announces Third Quarter 2022 Financial Results and Operational Highlights November 7, 2022 ?Received 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 follo |
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| November 7, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 7, 2022 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission |
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| November 3, 2022 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 3, 2022 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission |
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| November 3, 2022 |
Respiratory cell-type affinity and absolute CFTR expression in the primate airway upon nebulization of KB407 T r e v o r P a r r y , S a r a A r t u s i , J o r g e G u z m a n - L e p e , M a r y J a n e D u e r m e y e r , S u m a K r i s h n a n K r y s t a l B i o t e c h , I n c . |
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| August 18, 2022 |
FDA Accepts Krystal Biotech?s Biologics License Application for Dystrophic Epidermolysis Bullosa ? FDA granted Priority Review designation ? PDUFA target action date is February 17, 2023 ? FDA stated that it is not currently planning to hold an advisory committee meeting August 18, 2022 PITTSBURGH, August 18, 2022 (GLOBE NEWSWIRE) ? Krystal Biotech, Inc. |
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| August 18, 2022 |
Regulation FD Disclosure, Financial Statements and Exhibits, Other Events UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 18, 2022 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission F |
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| August 8, 2022 |
Krystal Biotech Announces Second Quarter 2022 Financial Results and Reports Updates on Operational Progress August 8, 2022 ?Biologics License Application for B-VEC filed with the FDA on June 22, 2022 ?FDA accepts IND on KB407 for the treatment of Cystic Fibrosis ?Strong balance sheet, closing the quarter with $438. |
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| August 8, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 or ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38210 Krystal Bi |
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| August 8, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 8, 2022 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission Fi |
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| June 22, 2022 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 22, 2022 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission Fil |
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| June 22, 2022 |
Krystal Biotech Submits Biologics License Application to U.S. FDA Seeking Approval of B-VEC for the Treatment of Patients with Dystrophic Epidermolysis Bullosa June 22, 2022 PITTSBURGH, June 22, 2022 (GLOBE NEWSWIRE) ? Krystal Biotech, Inc. (the ?Company?) (NASDAQ: KRYS), the leader in redosable gene therapy, announced today the submission of a Biologics License Application (BLA) to the U.S. Food |
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| May 26, 2022 |
Exhibit 16.1 May 26, 2022 Securities and Exchange Commission 100 F Street N.E. Washington, D.C. 20549 Commissioners: We have read Item 4.01 of Krystal Biotech, Inc.?s Form 8-K dated May 26, 2022, and we agree with the statements set forth in Item 4.01, insofar as they relate to our firm. We have no basis to agree or disagree with other statements made by the registrant contained in Item 4.01. Very |
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| May 26, 2022 |
Financial Statements and Exhibits, Changes in Registrant's Certifying Accountant UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 24, 2022 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File |
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| May 23, 2022 |
Submission of Matters to a Vote of Security Holders UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 23, 2022 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File |
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| May 20, 2022 |
GEM-3: Phase 3 Safety and Immunogenicity Results of Beremagene Geperpavec (B-VEC), an Investigational, Topical Gene Therapy for Dystrophic Epidermolysis Bullosa (DEB) Presented at the Society for Investigative Dermatology (SID) 2022 Annual Meeting, May 18-21, 2022, Portland, Oregon ? Dystrophic epidermolysis bullosa (DEB) is a serious, ultra-rare genetic blistering disease caused by mutations in t |
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| May 20, 2022 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 20, 2022 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File |
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| May 20, 2022 |
GEM-3: Phase 3 Safety and Immunogenicity Results of Beremagene Geperpavec (B-VEC), an Investigational, Topical Gene Therapy for Dystrophic Epidermolysis Bullosa (DEB) 1Stanford University, Redwood City, CA, USA; 2University of Miami, Miami, FL, USA; 3Mission Dermatology Center, Children?s Hospital of Orange County, University of California, Irvine, Department of Dermatology, Rancho Santa Margarita, CA, USA; 4Savio Group Analytics & Statistics, Hockessin, DE, USA; 5Krystal Biotech, Inc. |
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| May 9, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 or ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38210 Krystal B |
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| May 9, 2022 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 9, 2022 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File |
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| May 9, 2022 |
Exhibit 99.1 Krystal Biotech Announces First Quarter 2022 Financial Results and Reports Updates on Operational Progress May 9, 2022 ?Biologics License Application for B-VEC remains on track to file in the US in 2Q 2022 and Marketing Authorization in the EU on track to file in 2H 2022 ?FDA allows dosing at a patient?s home in the Open Label Extension Study of B-VEC for the treatment of DEB ?Positiv |
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| April 7, 2022 |
DEF 14A 1 d286126ddef14a.htm DEF 14A Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ☒ Filed by a Party other than the Registrant ☐ Check the appropriate box: ☐ Preliminary Proxy Statement ☐ Confidential, for Use of the Com |
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| April 7, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ? Filed by a Party other than the Registrant ? Check the appropriate box: ? Preliminary Proxy Statement ? Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ? Defin |
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| March 28, 2022 |
EX-99.1 AAD GEM-3 Phase 3 Data Conference Call © Copyright 2022 Krystal Biotech, Inc. All rights reserved. Exhibit 99.1 This presentation contains forward-looking statements that involve substantial risks and uncertainties. Any statements in this presentation about future expectations, plans and prospects for Krystal Biotech, Inc. (the “Company”), including but not limited to statements about the |
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| March 28, 2022 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 26, 2022 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission Fi |
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| March 22, 2022 |
Exhibit 99.1 Jeune Aesthetics Announces Positive Clinical Phase 1 (PEARL-1 Study) Efficacy Results for KB301, an Investigational Gene-based Treatment Designed to Address the Underlying Biology of Aging Skin ?Positive proof-of-concept efficacy data supports advancing into Phase 2 studies ?Adverse events, associated with injection site reactions, were mild and transitory ? Conference call to discuss |
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| March 22, 2022 |
A GENE-BASED AESTHETICS COMPANY March 2022 1 Exhibit 99.2 Forward Looking Statement 2 This presentation contains forward-looking statements that involve substantial risks and uncertainties. Any statements in this presentation about future expectations, plans and prospects for Krystal Biotech, Inc. and its wholly-owned subsidiary, Jeune Aesthetics, Inc. (collectively, the ?Company?), including but |
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| March 22, 2022 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 22, 2022 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission Fi |
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| March 15, 2022 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 15, 2022 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission Fi |
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| March 15, 2022 |
Krystal Biotech Announces Settlement with PeriphaGen, Inc. Exhibit 99.1 Krystal Biotech Announces Settlement with PeriphaGen, Inc. PITTSBURGH, March 15, 2022 ? Krystal Biotech, Inc., (?Krystal?) (NASDAQ: KRYS), the leader in redosable gene therapies for rare diseases, today announced it has reached a binding term sheet with PeriphaGen, Inc. (?PeriphaGen?) to resolve all claims in the trade secret litigation filed by PeriphaGen on May 20, 2020. Under the c |
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| February 28, 2022 |
1 NINTH AMENDMENT TO LEASE AGREEMENT THIS NINTH AMENDMENT TO LEASE AGREEMENT (this ?Ninth Amendment?) is made as of the 4th day of January 2022, by and between Wharton Lender Associates, LP, a Pennsylvania limited partnership (?Landlord?), and Krystal Biotech, Inc. |
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| February 28, 2022 |
sf-3750204KBca E M P L O Y M E N T A G R E E M E N T This Employment Agreement (?the Agreement?), dated December 6, 2021, is between Krystal Biotech, Inc. |
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| February 28, 2022 | ||
| February 28, 2022 |
Subsidiaries of Krystal Biotech, Inc. Exhibit 21.1 SUBSIDIARIES OF KRYSTAL BIOTECH, INC. AS OF DECEMBER 31, 2021 Name Direct Parent Ownership Jurisdiction of Incorporation Krystal Australia Pty Ltd Krystal Biotech, Inc. 100% Australia Jeune, Inc. Krystal Biotech, Inc. 100% Delaware |
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| February 28, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ? ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO Commission File Number 001-38210 Krystal Biotech |
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| February 28, 2022 |
1 EIGHTH AMENDMENT TO LEASE AGREEMENT THIS EIGHTH AMENDMENT TO LEASE AGREEMENT (this ?Eighth Amendment?) is made as of the 21st day of July 2021 (the ?Effective Date?), by and between Wharton Lender Associates, LP, a Pennsylvania limited partnership (?Landlord?), and Krystal Biotech, Inc. |
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| February 28, 2022 |
1 SEVENTH AMENDMENT TO LEASE AGREEMENT THIS SEVENTH AMENDMENT TO LEASE AGREEMENT (this ?Seventh Amendment?) is made as of the day of May 2021 (the ?Effective Date?), by and between Wharton Lender Associates, LP, a Pennsylvania limited partnership (?Landlord?), and Krystal Biotech, Inc. |
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| February 28, 2022 |
13th Larry Walsh COO |
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| February 28, 2022 |
Krystal Biotech Reports Fourth Quarter and Full Year 2021 Financial Results and Provides Update on Operational Progress ?Following successful completion of GEM-3 pivotal trial, Krystal is on track to file BLA for VyjuvekTM for the treatment of dystrophic epidermolysis bullosa in 1H 2022; MAA filing anticipated in 2H 2022 ?Phase 1 trial of KB407 in cystic fibrosis patients in Australia expected to begin in 1H 2022; IND filing and U. |
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| February 28, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 25, 2022 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission |
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| February 17, 2022 |
As filed with the Securities and Exchange Commission on February 17, 2022 As filed with the Securities and Exchange Commission on February 17, 2022 Registration No. |
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| February 17, 2022 |
Exhibit 107 Calculation of Filing Fee Tables Form S-8 (Form Type) Krystal Biotech, Inc. |
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| February 14, 2022 |
Exhibit 99.1 Joint Filing Agreement In accordance with Rule 13d-1(k)(1) under the Securities Exchange Act of 1934, as amended (the ?Exchange Act?), the undersigned hereby agree to the joint filing on behalf of each of them of a Statement on Schedule 13G (including any and all amendments thereto, the ?Schedule 13G?) relating to the Common Stock, $0.00001 par value per share, of Krystal Biotech, Inc |
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| February 14, 2022 |
KRYS / Krystal Biotech Inc / Redmile Group, LLC - SC 13G/A Passive Investment UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G/A Under the Securities Exchange Act of 1934 (Amendment No. 2) Krystal Biotech, Inc. (Name of Issuer) Common Stock, $0.00001 par value (Title of Class of Securities) 501147102 (CUSIP Number) December 31, 2021 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pur |
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| February 14, 2022 |
240.13d-102 Schedule 13G - Information to be included in statements filed pursuant to 240.13d-1(b), (c), and (d) and amendments thereto filed pursuant to 240.13d-2. Securities and Exchange Commission, Washington, D.C. 20549 Schedule 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* (Name of Issuer) Krystal Biotech, Inc. (Title of Class of Securities) Common Stock, Par Value $0.00001 |
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| February 9, 2022 |
KRYS / Krystal Biotech Inc / FMR LLC Passive Investment SCHEDULE 13G Amendment No. 4 KRYSTAL BIOTECH INC COMMON STOCK Cusip #501147102 Check the appropriate box to designate the rule pursuant to which this Schedule is filed: [x] Rule 13d-1(b) [ ] Rule 13d-1(c) [ ] Rule 13d-1(d) Cusip #501147102 Item 1: Reporting Person - FMR LLC Item 2: (a) [ ] (b) [ ] Item 4: Delaware Item 5: 0 Item 6: 0 Item 7: 1,978,289 Item 8: 0 Item 9: 1,978,289 Item 11: 7.879% It |
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| February 3, 2022 |
KRYS / Krystal Biotech Inc / BlackRock Inc. Passive Investment us5011471027020322.txt SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No: 1) KRYSTAL BIOTECH INC - (Name of Issuer) Common Stock - (Title of Class of Securities) 501147102 - (CUSIP Number) December 31, 2021 - (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant t |
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| January 18, 2022 |
Exhibit 99.1 Krystal Biotech Appoints Jing Marantz, MD, PhD, MBA as Chief Business Officer and Rand Sutherland, MD, MPH to its Board of Directors January 18, 2022 PITTSBURGH, January 18, 2022 (GLOBE NEWSWIRE) ? Krystal Biotech, Inc., (?Krystal?) (NASDAQ: KRYS), the leader in redosable gene therapies for rare disease, announced today the appointments of Jing Marantz as Chief Business Officer and Ra |
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| January 18, 2022 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): January 18, 2022 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission |
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| December 6, 2021 |
KRYS / Krystal Biotech Inc / Point72 Asset Management, L.P. - SCHEDULE 13G Passive Investment 240.13d-102 Schedule 13G - Information to be included in statements filed pursuant to 240.13d-1(b), (c), and (d) and amendments thereto filed pursuant to 240.13d-2. Securities and Exchange Commission, Washington, D.C. 20549 Schedule 13G Under the Securities Exchange Act of 1934 (Amendment No.)* (Name of Issuer) Krystal Biotech, Inc. (Title of Class of Securities) Common Stock, Par Value $0.00001 P |
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| December 6, 2021 |
Exhibit 99.1 JOINT FILING AGREEMENT The undersigned hereby agree that the foregoing statement on Schedule 13G is filed on behalf of each of the undersigned in accordance with the provisions of Rule 13d-1(k) under the Securities Exchange Act of 1934, as amended, and that all subsequent amendments to this statement on Schedule 13G may be filed on behalf of each of the undersigned without the necessi |
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| December 3, 2021 |
Entry into a Material Definitive Agreement, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 30, 2021 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission |
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| December 3, 2021 |
EX-1.1 2 d225152dex11.htm EX-1.1 Exhibit 1.1 Execution Version Krystal Biotech, Inc. 2,666,667 Shares Common Stock ($0.00001 par value) Underwriting Agreement New York, New York November 30, 2021 Goldman Sachs & Co. LLC BofA Securities, Inc. Cowen and Company, LLC William Blair & Company, L.L.C. As Representative of the several Underwriters, c/o Goldman Sachs & Co. LLC 200 West Street New York, Ne |
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| December 1, 2021 |
Table of Contents Filed Pursuant to Rule 424(b)(2) Registration Statement No. 333-237983 CALCULATION OF REGISTRATION FEE Title of Each Class of Securities to be Registered Amount to be Registered Maximum Aggregate Offering Price Per Share Maximum Aggregate Offering Price Amount of Registration Fee(1) Common Stock, $0.00001 par value per share 3,066,667 $75.00 $230,000,025 $21,321.00 (1) Calculated |
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| November 29, 2021 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 29, 2021 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission |
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| November 29, 2021 |
EX-99.2 3 d217944dex992.htm EX-99.2 The Leader in Redosable Gene Therapy for Rare Disease Topline GEM-3 Trial Results Call © Copyright 2021 Krystal Biotech, Inc. All rights reserved. Exhibit 99.2 Forward looking statements This presentation contains forward-looking statements that involve substantial risks and uncertainties. Any statements in this presentation about future expectations, plans and |
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| November 29, 2021 |
Subject To Completion Dated November 29, 2021 Table of Contents Filed Pursuant to Rule 424(b)(5) Registration No. 333-237983 The information in this preliminary prospectus supplement is not complete and may be changed. This preliminary prospectus supplement and the accompanying prospectus are part of an effective registration statement filed with the Securities and Exchange Commission. This preliminary prospectus supplement and the accompanyi |
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| November 29, 2021 |
EX-99.1 2 d217944dex991.htm EX-99.1 Exhibit 99.1 Krystal Biotech Announces Positive Topline Results from GEM-3 Pivotal Trial of VYJUVEK™ in Patients with Dystrophic Epidermolysis Bullosa - Pivotal GEM-3 trial met its primary endpoint of complete wound healing at six-month timepoints, and its secondary endpoint of complete wound healing at three-month timepoints - VYJUVEKTM was well tolerated, with |
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| November 8, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 or ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38210 Kryst |
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| November 8, 2021 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): November 8, 2021 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission |
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| November 8, 2021 |
EX-99.1 2 d238696dex991.htm EX-99.1 Exhibit 99.1 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 sh |
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| September 16, 2021 |
Entry into a Material Definitive Agreement, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): September 13, 2021 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commissio |
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| September 16, 2021 |
Guaranteed Maximum Price Amendment dated September 13, 2021. Exhibit 10.1 Document A133™ – 2019 Exhibit A Guaranteed Maximum Price Amendment This Amendment dated the 13th day of September in the year Two Thousand Twenty-One, is incorporated into the accompanying AIA Document A133™–2019, Standard Form of Agreement Between Owner and Construction Manager as Constructor where the basis of payment is the Cost of the Work Plus a Fee with a Guaranteed Maximum Pric |
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| August 19, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K/A (Amendment No. 1) CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 24, 2021 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorpora |
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| August 9, 2021 |
EX-99.2 3 d91447dex992.htm EX-99.2 The Leader in Redosable Gene Therapy for Rare Disease August 2021 © Copyright 2021 Krystal Biotech, Inc. All rights reserved. Exhibit 99.2 Forward looking statements This presentation contains forward-looking statements that involve substantial risks and uncertainties. Any statements in this presentation about future expectations, plans and prospects for Krystal |
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| August 9, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 or ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38210 Krystal Bi |
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| August 9, 2021 |
EX-10.1 2 exhibit101krystal-wtcon.htm EX-10.1 DocuSign Envelope ID: D218C14A-72DE-40BA-A9B4-171E7642CDD6 |
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| August 9, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 9, 2021 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission Fi |
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| August 9, 2021 |
EX-99.1 2 d91447dex991.htm EX-99.1 Exhibit 99.1 Krystal Biotech Reports Second Quarter 2021 Financial Results and Provides Update on Operational Progress • Top-line data from the pivotal GEM-3 study of B-VEC in dystrophic epidermolysis bullosa (“DEB”) on track for 4Q21 • Initiation of Phase 1 study of inhaled KB407 for the treatment of cystic fibrosis expected in 3Q21 • Our wholly-owned subsidiary |
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| August 2, 2021 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): August 2, 2021 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission Fi |
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| August 2, 2021 |
Exhibit 99.1 Jeune Aesthetics Announces Initiation of Dosing in Efficacy Cohort of KB301 Phase 1 trial to Assess Improvement in Skin Quality - KB301 is designed to deliver a full-length human type III collagen transgene via intradermal injection - Initial data from this efficacy cohort of the PEARL-1 study is anticipated in 4Q21 PITTSBURGH, August 2, 2021 – Jeune Aesthetics, Inc., a wholly-owned s |
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| July 7, 2021 |
Entry into a Material Definitive Agreement UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): June 30, 2021 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission Fil |
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| July 1, 2021 |
Exhibit 99.1 Krystal Biotech Provides Update on the Clinical Trial Evaluating Topical KB105 for the Treatment of TGM-1 Associated Ichthyosis - - New data include update from the fourth patient treated in the Phase 1/2 trial - - Repeat topical KB105 dosing continues to be well tolerated with no adverse events or evidence of immune response PITTSBURGH, July 1, 2021 ? Krystal Biotech Inc., (?Krystal? |
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| July 1, 2021 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): July 1, 2021 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File |
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| July 1, 2021 |
The Leader in Redosable Gene Therapy for Rare Disease July 2021 ? Copyright 2021 Krystal Biotech, Inc. |
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| May 24, 2021 |
Submission of Matters to a Vote of Security Holders UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 21, 2021 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File |
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| May 10, 2021 |
Financial Statements and Exhibits, Results of Operations and Financial Condition UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): May 10, 2021 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission File |
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| May 10, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ? QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 or ? TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38210 Krystal B |
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| May 10, 2021 |
EX-99.1 2 d31488dex991.htm EX-99.1 Exhibit 99.1 Krystal Biotech Reports First Quarter 2021 Financial Results and Provides Update on Operational Progress • Completed enrollment in pivotal GEM-3 study of B-VEC in dystrophic epidermolysis bullosa (DEB) • Strong balance sheet with March 31, 2021 cash, cash equivalents and short-term investments of $403.4 million PITTSBURGH, May 10, 2021 – Krystal Biot |
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| May 10, 2021 |
EX-10.1 2 krys-20210331ex101psa.htm EX-10.1 Exhibit 10.1 PURCHASE AND SALE AGREEMENT THIS PURCHASE AND SALE AGREEMENT (this “Agreement”) is entered into as of January 29, 2021 (the “Effective Date”) by and between NORTHFIELD I, LLC, an Ohio limited liability company (“Seller”), and KRYSTAL BIOTECH, INC., a Delaware corporation (“Purchaser”), and, solely with respect to Articles VII, XIV and XVI, A |
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| April 6, 2021 |
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ? Filed by a Party other than the Registrant ? Check the appropriate box: ? Preliminary Proxy Statement ? Confidential, for Use of the Commission Only (as permitted by Rule 14 |
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| April 6, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 14A Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934 (Amendment No. ) Filed by the Registrant ? Filed by a Party other than the Registrant ? Check the appropriate box: ? Preliminary Proxy Statement ? Confidential, for Use of the Commission Only (as permitted by Rule 14a-6(e)(2)) ? Defin |
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| March 24, 2021 |
Regulation FD Disclosure, Financial Statements and Exhibits UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 8-K CURRENT REPORT Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): March 24, 2021 KRYSTAL BIOTECH, INC. (Exact name of registrant as specified in its charter) Delaware 001-38210 82-1080209 (State or other jurisdiction of incorporation) (Commission Fi |
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| March 24, 2021 |
Exhibit 99.1 Krystal Biotech Announces Launch of Jeune, a Gene-Based Aesthetics Company, and Initial Phase 1 Safety Data for KB301 in Aesthetic Indications - Initial data from Cohort 1 of the PEARL-1 study shows safety and tolerability of repeat KB301 injections - Dr. Bhushan Hardas M.D., MBA appointed President, Jeune, Inc. PITTSBURGH, March 24, 2021 ? Krystal Biotech Inc., (?Krystal?) (NASDAQ: K |
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| March 9, 2021 |
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 SCHEDULE 13G Under the Securities Exchange Act of 1934 (Amendment No. 1)* Krystal Biotech, Inc. (Name of Issuer) Common Stock (Title of Class of Securities) 501147102 (CUSIP Number) March 1, 2021 (Date of Event Which Requires Filing of this Statement) Check the appropriate box to designate the rule pursuant to which this Sched |
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| March 1, 2021 |
EX-10.15 6 krys-20201231ex1015fift.htm EX-10.15 Exhibit 10.15 FIFTH AMENDMENT TO LEASE AGREEMENT THIS FIFTH AMENDMENT TO LEASE AGREEMENT (the "Fifth Amendment") is made as of the 10th day of December, 2018, by and between Wharton Lender Associates, L.P., a Pennsylvania limited partnership ("Landlord"), and Krystal Biotech Inc. a Delaware corporation formerly known as Krystal Biotech, LLC, a Califo |
