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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
File Number)		 (IRS Employer
Identification Number)
2100 Wharton Street, Suite 701
Pittsburgh, Pennsylvania 15203
(Address of principal executive offices, including Zip Code)
Registrant’s telephone number, including area code: (412) 586-5830

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each classTrading Symbol(s)Name of each exchange on which registered
Common StockKRYSNasdaq Global Select Market
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.  ☐



Item 7.01    Regulation FD Disclosure.

On August 28, 2024, Jeune Aesthetics, Inc. (the “Company”), a wholly owned subsidiary of Krystal Biotech, Inc., issued a press release announcing phase 1 (PEARL-1) positive interim safety and efficacy results for KB301 in the treatment of lateral canthal lines and dynamic wrinkles of the décolleté. In addition, the press release indicated that the Company and Krystal Biotech, Inc. would host a conference call and webcast at 4:30 p.m. ET on August 28, 2024, to discuss the PEARL-1 Cohort 3 and Cohort 4 interim results, the KB301 clinical development program, the Company's pipeline product candidates, and the strategic vision for the Company. For purposes of the call and webcast, the Company provided a slide presentation, which is available on the “Investors” section of Krystal Biotech, Inc.’s website at www.krystalbio.com. Copies of the press release and the slide presentation are attached hereto as Exhibit 99.1 and Exhibit 99.2, respectively, and are incorporated by reference herein.

The information in this Item 7.01 of this Current Report on Form 8-K and in Exhibits 99.1 and 99.2 attached hereto shall not be (i) deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, or (ii) incorporated into any registration statement or other document filed with the Securities and Exchange Commission by Krystal Biotech, Inc., whether made before or after the date hereof, regardless of any general incorporation language in such filing, except as shall be expressly set forth by specific reference in such filing.

Item 9.01    Financial Statements and Exhibits.

(d) Exhibits.
Exhibit
No.		Description
99.1
99.2
104
Cover Page Interactive Data file (embedded within the Inline XBRL document)


SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
Date: August 28, 2024  KRYSTAL BIOTECH, INC.
  By:/s/ Krish S. Krishnan
  Name:Krish S. Krishnan
  Title:Chairman and Chief Executive Officer


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.m. ET PITTSBURGH, August 28, 2024 (GLOBE NEWSWIRE) – Jeune Aesthetics, Inc. (“Jeune”), a wholly owned subsidiary of Krystal Biotech, Inc. (“Krystal”) (NASDAQ: KRYS) leveraging Krystal’s clinically validated gene-delivery platform to fundamentally address – and reverse – the biology of aging skin, announced today positive interim safety and efficacy results from both Cohorts 3 and 4 of PEARL-1, a Phase 1 study evaluating KB301, an investigational aesthetic treatment designed to deliver the COL3A1 transgene and increase type III collagen (“COL3”) levels in the skin, for the improvement of lateral canthal lines at rest in Cohort 3 and for the improvement of dynamic wrinkles of the décolleté in Cohort 4. “Today’s injectable aesthetics toolbox is limited to toxins and fillers which allow us to manipulate, but not rejuvenate, aging skin,” said Steve G. Yoelin, M.D., one of the principal investigators for PEARL-1. “With its unique mechanism of action and compelling early efficacy data, I am excited by the potential for KB301 to change the treatment paradigm in the field of medical aesthetics and meet the growing demand for treatments that fundamentally replenish the skin or delay signs of aging.” Meaningful and sustained improvements in skin aesthetic attributes, assessed using a Global Aesthetic Improvement Scale (“GAIS”), were reported by the study investigators and subjects alike in both the décolleté and lateral canthal regions. Increased subject satisfaction with wrinkle appearance was also reported using a Subject Satisfaction Questionnaire (“SSQ”). Dynamic Wrinkles of the Décolleté Topline Efficacy Results A total of 20 subjects were enrolled. Two subjects dropped out before completing KB301 treatments. The remaining 18 subjects were assessed for aesthetic improvement out to two months following KB301 injections in the décolleté region. Results included: • Study investigators reported clinically meaningful improvement in wrinkles both one and two months after treatment, as assessed by GAIS: o At two months: 94% of subjects had at least a one point improvement and 28% had a two point improvement - the maximum potential score on the GAIS scale. o At one month: 83% of subjects had at least a one point improvement and 28% had a two point improvement. Exhibit 99.1

 
• Subjects also reported improvements in wrinkles that increased from the first to second follow up month, as assessed by GAIS: o At two months: 89% of subjects reported at least a one point improvement and 39% reported a two point improvement. o At one month: 61% of subjects reported at least a one point improvement and 28% reported a two point improvement. • 94% of subjects reported improved satisfaction with their wrinkles’ appearance two months after treatment, as assessed by SSQ. • Improvements were also seen across multiple additional skin attributes, as assessed by GAIS, including crepiness, hydration, and radiance, for which investigators reported improvements of 1 point or better in 89%, 94%, and 94% of subjects, respectively, two months after treatment. Lateral Canthal Line Topline Efficacy Results A total of 13 subjects were enrolled. One subject dropped out before completing KB301 treatments. The remaining 12 subjects were assessed for aesthetic improvement out to two months following KB301 injections in the lateral canthal region. Results included: • Study investigators again reported clinically meaningful improvement in wrinkles both one and two months after treatment, as assessed by GAIS: o At two months: 75% of subjects had at least a one point improvement and 50% had a two point improvement. o At one month: 92% of subjects had at least a one point improvement and 50% had a two point improvement. • Subjects also reported improvements in wrinkles, as assessed by GAIS: o At two months: 50% of subjects reported at least a one point improvement and 25% reported a two point improvement. o At one month: 58% of subjects reported at least a one point improvement and 17% reported a two point improvement. • 67% of subjects reported improved satisfaction with their wrinkles’ appearance two months after treatment, as assessed by SSQ. • Improvements across multiple additional skin attributes were again reported, as assessed by GAIS, with investigators reporting one point or greater improvements in at least 75% of subjects for each of crepiness, hydration, and radiance, two months following treatment. Across both cohorts, the KB301 safety profile was consistent with prior clinical experience in Cohorts 1 and 2 and other injectable aesthetic products. Adverse events were primarily

 
injection associated, mild-to-moderate, and transient. No drug related serious adverse events were reported. “We are excited to share today’s data update in which we continue to see profound aesthetic benefits following KB301 administration in both the lateral canthal region and the décolleté, in line with our earlier findings from PEARL-1 Cohort 2,” said September Riharb, Senior Vice President of Jeune. “We are also pleased that, in addition to reporting improvements in fine lines and wrinkles, both study investigators and subjects alike reported high rates of improvement across a variety of key skin attributes, consistent with KB301’s paradigm-changing mechanism of delivering COL3A1 directly to the skin and restoring COL3 levels to more youthful levels. The natural looking results of KB301 rejuvenated skin are exactly what consumers are looking for today. On the basis of the strong results we saw in Cohort 4, we will be progressing KB301 into Phase 2 development for the treatment of dynamic wrinkles of the décolleté, a priority aesthetic site for which no FDA-approved injectables exist, and will be meeting with the FDA in the coming months to enable initiation of the Phase 2 study.” A subset of Cohort 4 subjects opted in to redose at the two month follow up timepoint, after completing the assessments described above. Additional data collection is ongoing in the redosed subjects. Upon completion, detailed results of PEARL-1 Cohorts 3 and 4 will be presented at future scientific conference(s). Conference Call, Webcast and Presentation Information Jeune and Krystal will host a conference call and webcast today, Wednesday, August 28, 2024, at 4:30 pm ET, to discuss the PEARL-1 Cohort 3 and Cohort 4 interim results, the KB301 clinical development program, Jeune’s pipeline product candidates, and the strategic vision for Jeune. Investors and the general public can access the live webcast at: https://www.webcaster4.com/Webcast/Page/3018/51166 For those unable to listen to the live webcast, a replay will be available on the Investor’s section of the Krystal website at www.krystalbio.com. About KB301 KB301 is an investigational aesthetic therapy employing Krystal’s novel replication-defective, non-integrating HSV-1-based vector to deliver two copies of the COL3A1 transgene and increase COL3 levels in skin to address signs of skin aging associated with declining collagen levels and damage of the skin’s extracellular matrix. KB301 is formulated as a solution for direct intradermal injection to aesthetic priority areas. About the PEARL-1 Study PEARL-1 is a multi-cohort Phase 1 study designed to evaluate the safety, tolerability, initial efficacy and duration of effect of intradermal KB301 injections in adult subjects. Previously disclosed results from Cohorts 1 and 2 revealed that repeat administration of KB301 to various

 
locations on the body was well-tolerated and, in 2022, Jeune announced positive proof-of- concept, safety, efficacy, and nine-month durability data from PEARL-1 Cohort 2 with respect to improvement of fine lines and wrinkles. Building on the results from Cohort 2, Cohorts 3 and 4 of PEARL-1 are open-label, single-arm cohorts designed to evaluate KB301 in two potential target indications for Phase 2, lateral canthal lines at rest and dynamic wrinkles of the décolleté. Details of the Phase 1 study can be found at www.clinicaltrials.gov under NCT identifier NCT04540900. About Jeune Aesthetics, Inc. Jeune Aesthetics, Inc., a wholly-owned subsidiary of Krystal Biotech, Inc., is a biotechnology company leveraging a clinically validated gene-delivery platform to fundamentally address – and reverse – the biology of aging skin. For more information, please visit http://www.jeuneinc.com. About Krystal Biotech, Inc. Krystal Biotech, Inc. (NASDAQ: KRYS) is a commercial-stage biotechnology company focused on the discovery, development and commercialization of genetic medicines to treat diseases with high unmet medical needs. VYJUVEK® is the Company’s first commercial product, the first-ever redosable gene therapy, and the first medicine approved by the FDA for the treatment of dystrophic epidermolysis bullosa. The Company is rapidly advancing a robust preclinical and clinical pipeline of investigational genetic medicines in respiratory, oncology, dermatology, ophthalmology, and aesthetics. Krystal Biotech is headquartered in Pittsburgh, Pennsylvania. For more information, please visit http://www.krystalbio.com, and follow @KrystalBiotech on LinkedIn and X (formerly Twitter). Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for Krystal Biotech, Inc., or its wholly-owned subsidiary, Jeune Aesthetics, Inc., including statements about the clinical utility of KB301; the potential for KB301 to change the treatment paradigm in the field of medical aesthetics and meet the growing demand for treatments that fundamentally replenish the skin or delay signs of aging; Krystal’s and Jeune’s plans to progress KB301 into Phase 2 development for the treatment of dynamic wrinkles of the décolleté, including timing of meeting with the FDA and the initiation of the Phase 2 study; Krystal’s proprietary, HSV-1 based gene delivery platform; and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward- looking statements as a result of various important factors, including: uncertainties associated with regulatory review of clinical trials, the availability or commercial potential of KB301, and such other important factors as are set forth under the caption “Risk Factors” in Krystal’s annual and quarterly reports on file with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Krystal’s and Jeune’s views as of the date of this press release. Krystal and Jeune anticipate that subsequent events and developments will cause their views to change. However, while Krystal and Jeune may elect to

 
update these forward-looking statements at some point in the future, they specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing Krystal’s and Jeune’s views as of any date subsequent to the date of this press release. CONTACT Investors and Media: Stéphane Paquette, PhD Krystal Biotech spaquette@krystalbio.com

 
August 2024 1 Revolutionizing Aesthetic Medicine KB301 PEARL-1 Interim Results for Dynamic Wrinkles of the Décolleté and Lateral Canthal Lines Exhibit 99.2

 
Forward-Looking Statements 2 This presentation, which includes the accompanying oral presentation, contains, and the answers to questions may contain, forward-looking statements that involve substantial risks and uncertainties. Any statements in this presentation about future expectations, plans and prospects for Jeune Aesthetics, Inc., a wholly-owned subsidiary of Krystal Biotech, Inc. (together, the “Company”), which may include but are not limited to statements about the clinical utility of KB301; the Company’s plans for a Phase 2 study evaluating KB301 for the treatment of dynamic wrinkles of the décolleté, including the expected timing of initiation of the Phase 2 study; the markets for aesthetic skin conditions and the primary and secondary tools for treating aesthetic skin conditions, including existing consumer demand for aesthetic treatments and expected market expansion trends; the projected aesthetic treatment ladder; the potential market for aesthetic treatments for aged skin; the development and commercialization of the Company’s pipeline product candidates, including conduct and timelines of clinical studies; the Company’s technology platform; and other statements containing the words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “may”, “plan”, “predict”, “project”, “target”, “potential”, “likely”, “will”, “would”, “could”, “should”, “continue” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties associated with regulatory reviews and clinical trials; the availability or commercial potential of the Company’s products; and such other important factors as are set forth in the Krystal Biotech Inc.’s filings with the U.S. Securities and Exchange Commission. The forward-looking statements included in this presentation represent the Company’s views as of the date of this presentation and should not be relied upon as representing the Company’s views as of any subsequent date. While the Company may elect to update these forward-looking statements, it specifically disclaims any obligation to do so. This presentation contains estimates and statistical data made by independent parties or the Company relating to, among other things, market size and growth. These estimates involve assumptions and limitations and should not be given undue weight. Neither the Company nor any other person makes any representation as to the accuracy or completeness of such estimates or data or undertakes any obligation to update such estimates or data. In addition, any projections, assumptions and estimates of the Company’s future performance and the future performance of the markets in which the Company operates are necessarily subject to a high degree of uncertainty and risk. All product candidates described in this presentation are investigational treatments. © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved.

 
Jeune Aesthetics: Wholly Owned Subsidiary of Krystal Biotech, Inc. 3*Jeune holds exclusive license to Krystal’s HSV-1 gene delivery platform for cash pay markets Subsidiary Dedicated to Aesthetics and Cash Pay Markets*  Clinical Development  Commercial Fully integrated biotech developing portfolio of genetic medicines R&D Finance / HR Manufacturing Legal Regulatory © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved.

 
Jeune’s Groundbreaking Skin Rejuvenation Technology 4 © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved.

 
Lead Program KB301 Designed to Increase Type III Collagen Levels in Aging Skin 5 Cohort 1 – Safety and PK* Cohort 2 – Initial Efficacy** Cohort 2E – Durability*** Cohorts 3 / 4 KB301 Phase 1 Program PEARL-1 KB301 Payload • Type III collagen (COL3) is the second most abundant protein in the skin but levels decline significantly with age • COL3 has been implicated in both new collagen fibril formation as well as regulation of collagen fibril diameter, organization, and elasticity • Consistent with its role as an early regulator of new collagen formation, COL3 expression has been used as a marker of clinical efficacy of fillers Jeune’s lead program KB301 is designed to increase COL3 expression from an individual’s own skin cells, restoring youthful collagen levels and rejuvenating the skin © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved. * Results presented at SID 2021 in May 2021 ** Results presented March 2022 *** Results presented November 2022 Fleischmajer R 1990 Ann N Y Acad Sci 580: 161-175; Fleischmajer R 1990 J Struct Biol 105: 162-169; Asgari M 2017 Sci Rep 7: 1392; Liu X 1997 Proc Natl Acad U S A 94: 1852-1856; Shuster S 1975 Br J Dermatol 93: 639; Wang P 2018 J Chin Med Assoc 81: 94-101; Yutsovskaya Y 2014 J Drugs Dermatol 13: 1047-1052; Xue M 2015 Adv Wound Care 4: 119-136; Hayakawa T 1979 Clin Chim Acta 93: 119-125 PK, pharmacokinetics

 
Aesthetic Improvement Reported at All KB301 Treatment Sites in Cohort 2 6 © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved. Both low and high dose KB301 generally well tolerated, with evidence of pharmacodynamic effect and aesthetic improvement across injection sites Cohort 2: Exploratory, 2:1 randomized, placebo-controlled study evaluating safety and efficacy of KB301, administered up to four times weekly, at either low and/or high dose, to the area above the knee, the lower cheek and upper cheek. 1.6 1.9 0.7 0.9 0.0 0.5 1.0 1.5 2.0 Visit 5 Visit 6 M ea n C ha ng e fr o m B as el in e Subject Satisfaction Score High Dose - KB301 Placebo n = 19 n = 9 Lower Cheek High Dose Upper Cheek Low Dose Above The Knee 1.74 0.67 0.0 0.5 1.0 1.5 2.0 Visit 5 M ea n C ha ng e, m m Skin Fold Thickness Change from Baseline High Dose - KB301 Placebo No signal detected at low dose (n = 12 with n = 6 matching placebo) 1.3 1.3 0.5 0.7 0.0 0.5 1.0 1.5 2.0 Visit 5 Visit 6 M ea n C ha ng e fr o m B as el in e Subject Satisfaction Score Low Dose - KB301 Placebo n = 31 n = 15 n = 31 n = 15 Only high dose was tested above the knee Only low dose was tested in the upper cheek

 
0 0.2 0.4 0.6 0.8 1 1.2 1.4 1.6 1.8 2 Baseline (n=13) Visit 5 (n=13) Visit 6 (n=12) Month 1 (n=13) Month 2 (n=13) Month 3 (n=10) M ea n C ha ng e in S SS fr o m B as el in e Change in Subject Satisfaction Score Lower Cheek High Dose Group Durability of at Least Nine Months Observed in Extension Follow Up 7 Cohort 2 (Efficacy) Cohort 2E (Durability) 5 -6 m o nt hs Scores remained elevated from baseline approximately 7-9 months after the last dose in Cohort 2 7 to 9 months after last dose Change in SSS compared to baseline (defined as the beginning of Cohort 2 prior to any treatment with KB301) Visit 5 and 6 correspond to 2 to 4 weeks after the last dose, depending on whether the subject received 3 or 4 doses Missing data at Visit 6 and Month 3 are due to missed study visits. © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved. SSS, Subject satisfaction score

 
Indications for Cohorts 3/4 Selected Based on KB301 Profile and Market Demand 8 © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved. Cohort 3 Cohort 4 Lateral Canthal Lines at Rest Dynamic Wrinkles of the Décolleté

 
Cohorts 3 and 4 Interim Data Review 9

 
Study Population • 13 subjects enrolled and 12 assessed through two month follow up • Assessed subjects: • Median 57 years of age (range = 31 to 68 years), 92% female • Six subjects received high dose KB301 with microneedling treatment • Two subjects received low dose KB301 and five subjects received high dose KB301 with standard syringe 10 © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved. PEARL-1 Cohort 3 Evaluating KB301 in Lateral Canthal Lines at Rest Study Objective and Design • Multicenter, open-label study evaluating KB301 for the improvement of lateral canthal lines at rest in adults • Key study objectives were safety and preliminary efficacy as assessed by investigator and subject, as well as images; surveys for efficacy assessment included • Investigator and Subject: 5-point Global Aesthetic Improvement Scale (GAIS) • Subject Only: Subject Satisfaction Questionnaire (SSQ) • Dosing and administration technique also explored as part of study • Key exclusion / inclusion criteria • Adults up to 75 years of age, Fitzpatrick phototype score I-IV • No skin conditions or aesthetic treatments in lateral canthal region, last 6 months Treatment Visits • Image Capture • Subject and Investigator Assessments • Weekly Treatments One Month Follow Up • Image Capture • Subject and Investigator Assessments Two Month Follow Up • Image Capture • Subject and Investigator Assessments One Month Abbreviated Treatment and Assessment Schedule for Interim Readout One Month

 
Interim Safety Findings in Lateral Canthal Region Both low and high dose KB301 generally well tolerated with no adverse change in safety profile upon repeat dosing Localized, Related or Possibly Related Adverse Events* Grade 1 Grade 2 Grade 3 Grade 4 Dryness 2 0 0 0 Erosion 0 2 0 0 Itching 6 0 0 0 Pain 2 6 0 0 Swelling 13 21 0 0 Texture 2 0 0 0 N 25 29 0 0 Possibly related or related systemic AE reported in 2 subjects: headache, chills, muscle aches (n=1 each) © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved. 11AE, adverse event *Total localized, possibly related or related AEs recorded over all visits and both right and left injection sites

 
0% 20% 40% 60% 80% 100% One Month Two Month Investigator Assessed 12 © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved. Clear and Clinically Meaningful Improvements in Lateral Canthal Lines 0% 20% 40% 60% 80% 100% One Month Two Month Subject Assessed +2 Point = (Much) Improved +1 Point = Somewhat Improved 0 Point = No Change -1 Point = Somewhat Worse -2 Point = (Much) Worse GAIS Results for Wrinkles / Lines Responder No Change or Worse Subject Satisfaction Responder Rate* Lateral Canthal Lines; Two Month Follow Up *Defined as subject satisfaction increase of one or more points n = 12 n = 12 for each timepoint Follow Up Period After Treatment n = 12 for each timepoint Follow Up Period After Treatment GAIS, Global Aesthetic Improvement Scale

 
0% 20% 40% 60% 80% 100% One Month Two Month Investigator Assessed 0% 20% 40% 60% 80% 100% One Month Two Month Subject Assessed Crepiness Elasticity Hydration Radiance Texture 13 © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved. Improvements Also Observed Across Multiple Other Skin Attributes GAIS Responder Rates* by Attribute *Defined as GAIS scores of +1 or +2 Additional attributes assessed and not shown, erythema and pigmentation, for which responder rates at month 1 / 2 ranged from 17% to 100%, n = 12 / timepoint n = 12 for each timepoint Follow Up Period After Treatment n = 12 for each timepoint Follow Up Period After Treatment GAIS, Global Aesthetic Improvement Scale

 
Lateral Canthal Lines Before and After Images 14Baseline Two Month Follow Up © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved.

 
Lateral Canthal Lines Before and After Images 15 © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved. Baseline Two Month Follow Up

 
16 © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved. PEARL-1 Cohort 4 Evaluating KB301 in Dynamic Wrinkles of the Décolleté Study Objective and Design • Multicenter, open-label study evaluating KB301 for the improvement of dynamic wrinkles of the décolleté in adults • Key study objectives were safety and preliminary efficacy as assessed by investigator and subject, as well as images; surveys for efficacy assessment included • Investigator and Subject: 5-point Global Aesthetic Improvement Scale (GAIS) • Subject Only: Subject Satisfaction Questionnaire (SSQ) • Key exclusion / inclusion criteria • Adults up to 75 years of age, Fitzpatrick phototype score I-IV • No skin conditions or aesthetic treatments in décolleté region, last 6 months Study Population • 20 subjects enrolled and 18 assessed through two month follow up • Assessed subjects: • Median 60 years of age (range = 42 to 74 years), all female • All received high dose KB301 with standard syringe Treatment Visits • Image Capture • Subject and Investigator Assessments • Weekly Treatments One Month Follow Up • Image Capture • Subject and Investigator Assessments Two Month Follow Up • Image Capture • Subject and Investigator Assessments One Month Abbreviated Treatment and Assessment Schedule for Interim Readout One Month

 
Interim Safety Findings in the Décolleté Region Localized, Related or Possibly Related Adverse Events* Grade 1 Grade 2 Grade 3 Grade 4 Bumps 14 1 0 0 Burning 1 0 0 0 Discomfort 0 1 0 0 Edema 1 0 0 0 Hypersensitivity 2 0 0 0 Itching 20 5 0 0 Pain 12 3 0 0 Redness 26 5 0 0 Swelling 2 3 0 0 Tenderness 12 0 0 0 Tightness 0 1 0 0 N 90 19 0 0 Possibly related or related systemic AE reported in 4 subjects: chills (n = 3), headache, muscle aches, dizziness, vomiting, swelling of hands (n=1 each) © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved. KB301 generally well tolerated with no adverse change in safety profile upon repeat dosing 17AE, adverse event *Total localized, possibly related or related AEs recorded over all visits

 
18 © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved. Profound Improvements Increasing With Time in the Décolleté Responder No Change or Worse Subject Satisfaction Responder Rate* Dynamic Wrinkles; Two Month Follow Up 0% 20% 40% 60% 80% 100% One Month Two Month Investigator Assessed GAIS Results for Wrinkles / Lines n = 18 n = 18 for each timepoint Follow Up Period After Treatment n = 18 for each timepoint Follow Up Period After Treatment 0% 20% 40% 60% 80% 100% One Month Two Month Subject Assessed +2 Point = (Much) Improved +1 Point = Somewhat Improved 0 Point = No Change -1 Point = Somewhat Worse -2 Point = (Much) Worse *Defined as subject satisfaction increase of one or more pointsGAIS, Global Aesthetic Improvement Scale

 
0% 20% 40% 60% 80% 100% One Month Two Month Investigator Assessed 19 © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved. Again Seeing Improvements Across Multiple Other Skin Attributes GAIS Responder Rates* by Attribute *Defined as GAIS scores of +1 or +2 Additional attributes assessed and not shown, erythema, pigmentation, for which responder rates at month 1 / 2 ranged from 41% to 82%, n = 15-18 0% 20% 40% 60% 80% 100% One Month Two Month Subject Assessed Crepiness Elasticity Hydration Radiance Texture n = 17-18 for each timepoint Follow Up Period After Treatment n = 18 for each timepoint Follow Up Period After Treatment GAIS, Global Aesthetic Improvement Scale

 
Décolleté Before and After Images 20 © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved. Baseline Two Month Follow Up

 
Décolleté Before and After Images 21 © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved. Baseline Two Month Follow Up

 
Décolleté Before and After Images 22 © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved. Baseline Two Month Follow Up

 
Next Steps and Market Opportunity 23

 
Next Steps for KB301 24  Select indication for Phase 2 development – completed, décolleté selected  Develop KB301-specific scale and assessment tool for patient report outcomes  Initiate Phase 2 development – target study start 2025  © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved.

 
No Primary Aesthetic Tool Addresses Aged Skin Fillers: Fat and Bone Loss Neuromodulators: Dynamic Wrinkles NO PRIMARY TOOL Aged Skin © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved. 25

 
Address Root Cause of Skin Aging Injected with Standard Syringes and Needles Shipped and Stored like other Injectables No Capital Equipment Investment Jeune Technology Jeune Technology Jeune Technology Jeune Technology Ideal Primary Tool for Skin Rejuvenation © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved. 26

 
4.5M Aesthetic Injection Consumers Globally1 No FDA Approved Aesthetic Injectables for the Décolleté © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved. 1 International Society of Plastic Surgery, Global Survey, 2022. Consumer number calculated from global neurotoxin procedures divided by two 2 The Best Anti-Aging Chest and Décolletage Products and Derm Treatments | Vogue The Décolleté: New Emphasis is Being Given to Keeping the Area as Fresh as your Face2 27 Significant Existing Consumer Demand

 
Significant Market Expansion Trends Growing Skin Rejuvenation Market1 WW Annual Expenditure $24.6B 2023 $44.5B 2030 Increasing Demand due to GLP-1 Accelerated Skin Aging3 Collagen and Elastin Damage in Skin due to Significant Weight loss © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved. Prejuvenation2 Growth of Minimally Invasive Procedures in Millennials Gen Z is 22% of Global Population 1 Br J Dermatol 2023; 189:i17–i23 2 Gen Z and Gen Alpha Infographic Update – McCrindle 3 Ozempic Is Changing People’s Skin, Say Plastic Surgeons | Allure 28

 
Projected Aesthetic Treatment Ladder © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved. 29 OTC Beauty Lotions Aesthetic Practice Visit Skin Rejuvenation with Jeune Technology Addition of Neurotoxin and Filler

 
Market Size Fillers: Fat and Bone Loss Neuromodulators: Dynamic Wrinkles Aged Skin POTENTIAL MARKET $5B $4B $5B Global filler revenue : https://www.fortunebusinessinsights.com/industry-reports/dermal-fillers-market-100939 Global neuromodulators revenue: AbbVie earnings and Aesthetics Market Resilience: AbbVie Asserts Widely Used Botox Dominance Amidst Rising Competition (yahoo.com) © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved. 30

 
Deep Pipeline Targeting Priority Extracellular Matrix Proteins Including Elastin 31 PROGRAM INDICATION PAYLOAD PRE-CLINICAL PHASE 1 PHASE 2 KB301 Dynamic Wrinkles of the Décolleté Type III collagen (COL3) KB303 TBD elastin (ELN) KB304 TBD COL3 + ELN KB302 TBD Type 1 collagen (COL1) KB305 TBD Type IV collagen (COL4) Jeune Aesthetics Pipeline Arrows denote human elastic fibers Human Elastin Immunohistochemistry KB303 Treated Mouse Skin KB303 for the Delivery of Elastin • Late preclinical stage program with data package to support progression into clinic for treatment of skin elasticity loss • Transduction and elastin secretion by skin cells in vitro • Expression and elastin fiber formation confirmed in both young and aged mice treated with KB303 • KB304 combination vector is also in advanced preclinical development © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved.

 
32 Long Term Strategic Vision for Jeune Vision: Creating a new segment of fundamentally rejuvenative aesthetics built on Krystal’s proprietary gene delivery platform  Krystal well-positioned to rapidly advance KB301 through value-creating Phase 2 milestones  As KB301 progresses in the clinic, need for dedicated resource and commercial aesthetics expertise will grow  Jeune was purpose-built as wholly owned subsidiary to allow optionality for spin-out or partnership during clinical development © Copyright 2024 Jeune Aesthetics, Inc. All rights reserved.

 
Closing and Q&A 33

 
v3.24.2.u1
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Aug. 28, 2024
Cover [Abstract]  
Document Type 8-K
Document Period End Date Aug. 28, 2024
Entity Registrant Name KRYSTAL BIOTECH, INC.
Entity Incorporation, State or Country Code DE
Entity File Number 001-38210
Entity Tax Identification Number 82-1080209
Entity Address, Address Line One 2100 Wharton Street
Entity Address, Address Line Two Suite 701
Entity Address, City or Town Pittsburgh
Entity Address, State or Province PA
Entity Address, Postal Zip Code 15203
City Area Code 412
Local Phone Number 586-5830
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Entity Emerging Growth Company false
Amendment Flag false
Entity Central Index Key 0001711279
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