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Krystal Biotech, Inc. (KRYS) SEC Filing 10-Q Quarterly report for the period ending Tuesday, March 31, 2020

SEC Filings

KRYS Quarterly Reports

Krystal Biotech, Inc.

CIK: 1711279 Ticker: KRYS

Exhibit 99.1

 

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Krystal Biotech Reports 2019 Financial Results and Business Progress

Phase 3 trial of B-VEC (Beremagene Geperpavec, previously “KB103”) to treat dystrophic epidermolysis

bullosa (“DEB”) to start in 1H 2020

Interim results on Phase 1/2 clinical study on KB105 to be announced in 1H 2020

Planned filing of two Investigational New Drug Applications (“INDs”), one for rare skin disease and

another for an aesthetic skin indication, in 2H 2020

Company strengthens portfolio with four new patents covering B-VEC, KB105 and the STAR-D platform

PITTSBURGH, March 10, 2020 – 

Krystal Biotech Inc., (“Krystal”) (NASDAQ: KRYS), a gene therapy company developing medicines to treat dermatological diseases, announces financial results for 2019 and an update on its business progress.

Krish S. Krishnan, chairman and chief executive officer of Krystal Biotech stated, “2020 is expected to be an exciting year for Krystal as we get ready to commence the pivotal study of B-VEC, and announce interim Phase 1/2 clinical results on KB105 in the first half of 2020. In January, we hired a chief commercial officer to build out our market access and commercial team for the anticipated launch of B-VEC and also broke ground on our second cGMP manufacturing facility, ASTRA, a 100,000 square foot facility that will be built-out and validated over the next 12-15 months to serve our future pipeline products. On the research front, our research, clinical and regulatory teams are working to initiate a Phase 1 clinical study in an aesthetic skin indication and file an IND for a third rare disease indication in the second half of 2020.

“2019 was a busy year for Krystal as we worked to become fully-integrated in the gene therapy space. On the clinical front, we announced positive results from the Phase 1/2 results of B-VEC to treat DEB and the initiation of a Phase 1/2 clinical study of KB105 for the treatment of TGM1-deficient autosomal recessive congenital ichthyosis (“ARCI”) in October. On the manufacturing front, we initiated manufacturing of our Phase 3 clinical material at ANCORIS, our first cGMP facility for the clinical and future commercial production of B-VEC, that was completed early in 2020. We strengthened our patent portfolio with the issuance of our first foreign patent for B-VEC and broadened our platform patent for skin-targeted therapeutics as well as methods of its use for delivering any effector of interest to the skin.”

2019 and Recent Corporate Highlights

Manufacturing

 

   

On January 24, 2020, we announced the ground-breaking of the second commercial gene therapy facility in Findlay Township, Pennsylvania. The facility, named ASTRA, will have the capacity to produce commercial gene therapy medicines to treat patients suffering from debilitating rare diseases. The ASTRA facility is being designed as a state-


The following information was filed by Krystal Biotech, Inc. (KRYS) on Tuesday, March 10, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Document And Entity Information
Condensed Consolidated Balance Sheets
Condensed Consolidated Balance Sheets (Parenthetical)
Condensed Consolidated Statements Of Cash Flows
Condensed Consolidated Statements Of Operations And Comprehensive Loss
Condensed Consolidated Statements Of Stockholders' Equity
Balance Sheet Components
Balance Sheet Components (Tables)
Balance Sheet Components - Additional Information (Detail)
Balance Sheet Components - Schedule Of Accrued Expenses And Other Current Liabilities (Detail)
Balance Sheet Components - Schedule Of Property And Equipment, Net (Detail)
Capitalization
Capitalization - Additional Information (Detail)
Commitments And Contingencies
Commitments And Contingencies (Tables)
Commitments And Contingencies - Additional Information (Detail)
Commitments And Contingencies - Schedule Of Future Minimum Operating Lease Payments (Detail)
Fair Value Instruments
Fair Value Instruments (Tables)
Fair Value Instruments - Summary Of Cash, Cash Equivalents And Available-For-Sale Securities (Detail)
Net Loss Per Share Attributable To Common Stockholders
Net Loss Per Share Attributable To Common Stockholders (Tables)
Net Loss Per Share Attributable To Common Stockholders - Additional Information (Detail)
Net Loss Per Share Attributable To Common Stockholders - Schedule Of Basic And Diluted Net Loss Per Share And Per Unit (Detail)
Organization
Organization - Additional Information (Detail)
Related Party Transactions
Related Party Transactions - Additional Information (Detail)
Stock-Based Compensation
Stock-Based Compensation (Tables)
Stock-Based Compensation - Additional Information (Detail)
Stock-Based Compensation - Fair Value Of Stock Options, Valuation Assumptions (Detail)
Stock-Based Compensation - Schedule Of Company's Stock Option Activity (Detail)
Stock-Based Compensation - Summary Of Stock Based Compensation Expense Related To Issuance Of Stock Option Awards And Restricted Stock Awards (Detail)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
Summary Of Significant Accounting Policies (Tables)
Summary Of Significant Accounting Policies - Additional Information (Detail)
Summary Of Significant Accounting Policies - Summary Of Estimated Useful Lives Of Assets (Detail)
Ticker: KRYS
CIK: 1711279
Form Type: 10-Q Quarterly Report
Accession Number: 0001564590-20-020571
Submitted to the SEC: Fri May 01 2020 6:32:25 PM EST
Accepted by the SEC: Mon May 04 2020
Period: Tuesday, March 31, 2020
Industry: Biological Products No Disgnostic Substances

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