Krystal Biotech Stock

Krystal Biotech, Inc. operates as a fully integrated, commercial-stage biotechnology company.

The company focuses on the discovery, development, and commercialization of genetic medicines to treat diseases with high unmet medical needs. The company’s first commercial product, VYJUVEK, was approved by the FDA on May 19, 2023 for the treatment of DEB, and the company subsequently initiated its U.S. commercial launch. VYJUVEK is the first medicine approved by the FDA for the treatment of DEB.

Using the company’s patented gene therapy technology platform that is based on engineered HSV-1, the company creates vectors that efficiently deliver therapeutic transgenes to cells of interest in multiple organ systems. The cell’s own machinery then transcribes and translates the encoded effector to treat or prevent disease. The company formulates its vectors for non-invasive or minimally invasive routes of administration at a healthcare professional’s office or in the patient’s home by a healthcare professional. The company’s intention is to develop easy-to-use medicines to dramatically improve the lives of patients living with rare and serious diseases. The company’s innovative technology platform is supported by an in-house, FDA-inspected commercial scale Current Good Manufacturing Practice (‘CGMP’) manufacturing facility and a second, completed and qualified, commercial scale CGMP facility to support future expansion.

The company’s development pipeline includes multiple clinical stage programs for rare and serious diseases, and the company is investing in research and development to advance and grow this pipeline. The company possesses exclusive rights to develop, manufacture, and commercialize its FDA approved product and the company’s pipeline candidates throughout the world.

While the company’s focus is on the development of gene therapies to treat patients with severe, life-threatening, or rare diseases with high unmet medical needs, the company is also evaluating the potential of the company’s platform to address more prevalent and/or non-genetic conditions. To that end, in April 2019, the company incorporated Jeune Aesthetics, Inc. (‘Jeune Aesthetics’), a wholly-owned subsidiary, for the purposes of undertaking preclinical and clinical studies for aesthetic skin conditions.

FDA Approved Commercial Product

VYJUVEK (beremagene geperpavec-svdt, or B-VEC; referred to as B-VEC outside the U.S.)

B-VEC

B-VEC is a redosable, off-the-shelf gene therapy designed to deliver two copies of the COL7A1 gene when applied topically, directly onto an open wound. Unlike the previous standard of care, B-VEC treats DEB at the molecular level by providing the patient’s skin cells the template to make normal COL7 protein, thereby addressing the fundamental disease-causing mechanism. B-VEC was specifically designed to be easily administered by a healthcare professional in a doctor’s office or at the patient’s home. B-VEC was approved by the FDA in May 2023 and is marketed as VYJUVEK in the United States.

The company’s approach to treating DEB is positively differentiated relative to palliative approaches, which do not address the underlying genetic cause of DEB or impact the durability of wound closure, and other known efforts to develop corrective treatments that employ autologous approaches. Autologous treatments use a patient’s own tissues and cells to manufacture an individualized therapy. Such therapies tend to be expensive, invasive and time consuming to use, and require extensive patient travel, extended hospital stays, highly sophisticated medical teams and procedures.

Commercial Launch

The company launched VYJUVEK, the first FDA approved treatment for DEB and the first and only corrective therapy for DEB globally, in the United States in the second quarter of 2023.

Commercial readiness efforts had been underway over two years prior to the FDA approval of VYJUVEK. In the United States, prior to FDA approval and VYJUVEK launch, as part of the company’s disease awareness program, the company’s medical science liaisons had been interacting with and educating health care professionals (‘HCPs’) on DEB and the importance of genetic testing in ensuring an accurate diagnosis. The company also built-out Krystal ConnectTM, the company’s U.S. in-house patient services call center staffed with Krystal employees, which was launched subsequent to FDA approval to assist patients, caregivers and HCPs interested in accessing VYJUVEK. Additionally, the company hired, trained and deployed commercial field teams to educate on DEB and to prepare for launch of VYJUVEK. The company’s field force has been fully deployed since launch and is covering both centers of excellence and community physicians treating patients with DEB.

The company’s market access team had successfully secured positive policies or coverage decisions from plans covering over 93% of commercial and Medicaid lives in the United States, including positive coverage determinations from all major commercial national health plans and several regional health plans. In January 2024, the company announced that the United States Centers for Medicare & Medicaid Services (‘CMS’) had assigned a permanent and product-specific J-code (J3401) for VYJUVEK, effective on January 1, 2024.

VYJUVEK is distributed in the U.S. through a limited network of specialty pharmacy providers that administer the medication to patients in their homes and specialty distributors that distribute VYJUVEK for administration to patients at the site of care.

Preparations and infrastructure buildout are underway in Europe and Japan to support direct commercial launch by Krystal in these regions, which is expected by 2025. The company has also initiated a named patient program in Europe to provide initial access to VYJUVEK. Outside of Germany, France, Italy, Spain, the United Kingdom, and Japan, the company’s strategy is to enter into distribution arrangements with local distributors to commercialize VYJUVEK.

Regulatory Status

On May 19, 2023, the FDA approved VYJUVEK, the first ever redosable gene therapy, for treating patients, six months of age or older, suffering from DEB. No clinical post-marketing commitments or Risk Evaluation and Mitigation Strategies program were required by the FDA. With the approval, the FDA issued a Rare Pediatric Disease Priority Review Voucher (‘PRV’), which confers priority review to a subsequent drug application that would not otherwise qualify for priority review. The company sold the PRV in the third quarter of 2023 for $100.0 million.

The FDA had previously granted B-VEC Orphan Drug Designation (‘ODD’), Fast Track Designation, Rare Pediatric Designation, and granted Regenerative Medicine Advanced Therapy to B-VEC for the treatment of DEB.

In September 2023, the company received a positive opinion from the EMA Pediatric Committee on the Pediatric Investigation Plan for B-VEC for the treatment of DEB. Based on this positive opinion, the company expects to be eligible for up to an additional two years of marketing exclusivity in the European Union (‘EU’), on top of the ten-year EU market exclusivity after market approval in the EU. The European regulatory authorities have also granted B-VEC Orphan Designation and PRIority MEdicines eligibility for B-VEC to treat DEB.

In October 2023, the company submitted a marketing authorization application (‘MAA’) to the EMA for B-VEC for the treatment of DEB in patients from birth. In November 2023, the company was notified that the MAA had been validated and was now under Committee for Medicinal Products for Human Use review. The company expects an EMA decision on its MAA in the second half of 2024.

In December 2023, B-VEC was granted ODD status for the treatment of DEB by the Japan Ministry of Health, Labour and Welfare, a designation which confers specific benefits for orphan drug development including priority review of applications, extended registration validity, and reduced development costs. The company anticipates filing its Japan New Drug Application with Japan’s Pharmaceuticals and Medical Devices Agency (‘PMDA’) in the second half of 2024 enabling a potential authorization in 2025.

Clinical Development

The company initiated Phase 1 testing of a topical formulation of B-VEC in May 2018 at Stanford University, and the company announced positive interim results from this clinical study on two patients in October 2018. The Phase 2 portion of the trial commenced in December 2018 at Stanford University, and the company announced positive interim results from this clinical study on June 24, 2019. In March 2022, results from the complete Phase 1/2 study of topical B-VEC for the treatment of DEB were published in Nature Medicine.

The company initiated a pivotal Phase 3 trial (‘GEM-3 trial’) in July 2020. The GEM-3 trial of topical B-VEC for the treatment of DEB was a randomized, double-blind, intra-patient placebo-controlled multicenter study designed to evaluate the efficacy and safety of B-VEC for patients suffering from both recessive and dominant forms of DEB. The trial enrolled 31 participants with DEB, aged 6 months or older at time of consent. In each patient, a primary wound pair was identified by the investigator; one wound was randomized to receive a weekly topical application of B-VEC and the other to receive placebo. These primary wounds were treated once weekly for six months until wound closure. If a wound re-opened at any point during the study, weekly dosage resumed until closure. The dose administered to each wound was dependent on the size of the wound. A maximum vector dose per patient per week was defined on the basis of preclinical and clinical safety data. In the event that the maximum dose per patient had not been reached based on dosing of the primary wounds, the study investigators and patients had the opportunity to select additional ‘secondary’ wounds across which the remaining weekly dose was applied. The company announced positive results from the GEM-3 trial in November 2021 and in December 2022 full results from the GEM-3 trial were published in the New England Journal of Medicine.

Following completion of the GEM-3 trial, the company initiated an open label extension study (‘OLE’) to provide extension of B-VEC treatment for participants who completed study GEM-3 (‘rollover participants’) and B-VEC treatment for newly enrolling (‘naïve participants’) participants with DEB. The OLE was a multi-center, open-label study of B-VEC for the topical treatment of DEB wounds. The study enrolled 47 participants in total, comprising of 24 rollover participants and 23 naïve participants, at five sites in the United States. In April 2022, following feedback from the FDA, the company announced that patients enrolled in the OLE study would have the option to be dosed in their homes by a health care professional. The primary study objective was the assessment of safety and tolerability of extended dosing with B-VEC in a broader patient population. Various quality of life and participant satisfaction metrics were also assessed. The OLE study was concluded in the third quarter of 2023, and the safety profile continued to support the overall benefit-risk of B-VEC, with no new safety concerns noted with extended duration of dosing of B-VEC. The company expects to disclose detailed study data at upcoming scientific meetings or in scientific publications.

In July 2023, the PMDA in Japan officially accepted the company’s OLE study of B-VEC in Japanese patients (the ‘Japan OLE’). Following that acceptance, the company initiated the Japan OLE study and completed study enrollment. The company expects to complete the study in 2024.

Pipeline Programs

Ophthalmology

Ophthalmic B-VEC for Ocular Complications of DEB

Ophthalmic B-VEC

Ophthalmic B-VEC is a redosable eye drop formulation of B-VEC, designed to deliver two copies of the COL7A1 transgene to the epithelial cells in a patient’s eye to produce COL7 protein. As with VYJUVEK, the goal of therapy with ophthalmic B-VEC is to treat the disease locally, at the molecular level, by providing the patient’s epithelial cells of the eye the template to make normal COL7 protein, and thereby address the fundamental disease-causing mechanism. In preclinical studies, single and repeated topical B-VEC administration to the eye in a mouse corneal lesion model resulted in localized COL7A1 expression with no adverse effects noted histologically.

Ophthalmic B-VEC has been applied topically to the eye of one DEB patient under a compassionate use protocol. The clinical observations of this compassionate use case were published in the New England Journal of Medicine in February 2024. The patient presented with severe cicatrizing conjunctivitis secondary to DEB. Surgical symblepharon lysis of the patient’s right eye with pannus removal was conducted and regular administration of B-VEC as an eye drop directly to the eye (5×109 PFU/mL) were added to routine post-surgical care, three times weekly for the first two weeks and then once weekly. B-VEC application frequency was further decreased to once monthly once the corneal epithelium was healed. B-VEC was well tolerated with no drug related adverse events noted. Full corneal healing was observed at 3 months, as well as significant visual acuity improvement from hand motion to 20/25 by 8 months.

In February 2024, the FDA agreed with the company’s proposed single arm, open label study in approximately 10 patients to enable approval of B-VEC eyedrops to treat ocular complications secondary to DEB. The company plans to initiate this study in the second half of 2024.

Respiratory

KB407 for Cystic Fibrosis (‘CF’)

KB407

KB407 is a redosable off the-shelf gene therapy designed to deliver two copies of the full-length CFTR transgene directly to the airway epithelia via inhaled (nebulized) administration. By inducing expression of full length, normal CFTR protein in the lung, treatment with KB407 has potential to restore ion and water flow into and out of lung cells to correct the lung manifestations of the disease in patients regardless of their underlying genetic mutation. Preclinical efforts to date have shown that KB407 successfully transduces patient-derived epithelial cells and delivers functional CFTR in vitro in 2D and 3D organotypic systems, and is amendable to non-invasive inhaled administration in vivo, as indicated by successful delivery to the lungs through the use of a clinically relevant nebulizer in small animal models. Successful delivery and distribution throughout the lung also was observed in a nonhuman primate.

The FDA and the EMA have granted KB407 ODD and Orphan Designation, respectively, for the treatment of cystic fibrosis, and the FDA has granted KB407 Rare Pediatric Designation for the treatment of cystic fibrosis.

Clinical Development of KB407

In July 2023, the company had dosed the first patient in its Phase 1 CORAL-1 study evaluating KB407, delivered via a nebulizer, for the treatment of patients with CF. The CORAL-1 study is a multi-center, dose-escalation trial of KB407 in patients with CF, regardless of their underlying genotype. In the fourth quarter of 2023, the company completed the first cohort of the CORAL-1 study with no severe or serious adverse events, and in January 2024, the company initiated dosing in the second of three cohorts.

KB408 for Alpha-1 Antitrypsin Deficiency (‘AATD’)

KB408

KB408 is an inhaled (nebulized) formulation of the company’s proprietary vector, designed to deliver two copies of the SERPINA1 transgene that encodes functional, full-length human AAT protein, for the treatment of AATD. Preclinical studies have shown that KB408 successfully transduces patient-derived lung epithelial cells in vitro, leading to production and secretion of full-length human AAT protein capable of irreversibly binding its cognate target NE. In small animal models, analysis of lung tissue biopsies, serum, and bronchoalveolar lavage fluid harvested 24 and 48 hours after inhalation of KB408 shows secretion of full-length AAT protein, with no evidence of significant or systemic toxicity.

In September 2023, the FDA granted KB408 ODD for the treatment of AATD.

Clinical Development of KB408

In September 2023, the company announced that the FDA had accepted the company’s Investigational New Drug (‘IND’) application to evaluate KB408, delivered via a nebulizer, in a clinical trial to treat patients with AATD. In February 2024, the company dosed the first patient in the KB408 Phase 1 SERPENTINE-1 study for the treatment of Alpha-1 Antitrypsin Deficiency. SERPENTINE-1 is a Phase 1 open-label, single dose escalation study in adult patients with AATD with a PI*ZZ genotype. Three planned dose levels of KB408 will be evaluated in up to 12 patients to evaluate the safety, tolerability, and proof-of-mechanism of KB408. Cohorts 1 and 2 will focus predominantly on safety with dose escalation and pharmacodynamic activity in the lung will be assessed at the highest dose by bronchoscopy in Cohort 3. The company is working closely with the Alpha-1 Foundation and their Therapeutic Development Network on the SERPENTINE-1 study and intends to announce interim data from the study in the second half of 2024.

Oncology

KB707 for Solid Tumors

KB707

KB707is a redosable, immunotherapy designed to deliver genes encoding both human interleukin-2 (‘IL-2’) and interleukin-12 (‘IL-12’) to the tumor microenvironment and promote systemic immune-mediated tumor clearance. Two formulations of KB707 are in development, a solution formulation for transcutaneous injection and an inhaled (nebulized) formulation for lung delivery. IL-2 and IL-12 are secreted cytokines with complementary functions promoting cell-mediated immunity in humans. Both IL-2 and IL-12 have been shown to elicit anti-tumor immune responses in preclinical or clinical models and have been extensively studied for their potential in cancer immunotherapy. Despite promising signs of efficacy, it has proven difficult to effectively harness IL-2 and IL-12 for therapeutic benefit, as systemic administration is often poorly tolerated, and the inherently short half-lives of these cytokines necessitate high dose levels and extremely frequent dose intervals. KB707 leverages the company’s HSV-1 vector platform – and its ability to efficiently deliver a durable DNA payload without active replication and minimal cytotoxicity – to drive local and sustained cytokine expression within the tumor microenvironment and maximize the therapeutic window and benefit of IL-2 and IL-12.

In preclinical studies, KB707 has been shown to efficiently transduce mammalian cells in vitro leading to the secretion of bioactive IL-2 and IL-12 and drive localized, durable cytokine expression in mouse skin after intradermal injection. Furthermore, in stringent, checkpoint inhibitor refractory ‘cold’ syngeneic mouse models, HSV-1 vector based delivery of murine equivalent IL2 and IL12 elicited robust antitumor responses and survival benefits, including via intratumoral injection in single and dual flank B16F10 melanoma models, as well as via intratracheal delivery in a metastatic K7M2 osteosarcoma model, with evidence of protection from tumor rechallenge in both models suggestive of prolonged adaptive immunity.

In July 2023, the FDA granted intratumoral KB707 Fast Track Designation for the treatment of anti-programmed cell death protein-1 (‘PD-1’) relapsed/refractory locally advanced or metastatic melanoma. In February 2024, the FDA also granted inhaled KB707 Fast Track Designation for the treatment of patients with solid tumors with pulmonary metastases that are relapsed or refractory to standard of care therapy.

Clinical Development of KB707

In July 2023, the company announced that the FDA had accepted the company’s IND application to evaluate intratumoral KB707 in a clinical trial to treat patients with locally advanced or metastatic solid tumors. The study, OPAL-1, is an open-label, multi-center, monotherapy, dose escalation and expansion Phase 1 study, enrolling patients with locally advanced or metastatic solid tumors, who relapsed or are refractory to standard of care, with at least one measurable and injectable tumor accessible by transcutaneous route. The primary objective of the study is to evaluate safety and tolerability of KB707. Efficacy will also be assessed by multiple measures, including overall response rate, progression free survival, and overall survival, and the immune effects of KB707 monotherapy will be assessed in tumor tissue, lymph nodes, and blood. The first patient in OPAL-1 was dosed in October 2023 and enrollment is ongoing.

In January 2024, the FDA accepted an amendment to the company’s IND application to evaluate inhaled KB707 in a clinical trial to treat patients with locally advanced or metastatic solid tumors of the lung. The company plans on initiating this open-label, multi-center, monotherapy, dose escalation and expansion Phase 1 study, KYANITE-1, in the first half of 2024.

Dermatology

KB105 for TGM1-Deficient Autosomal Recessive Congenital Ichthyosis (‘ARCI’)

KB105

KB105 is a redosable, off the-shelf gene therapy designed to deliver two copies of the TGM1 gene when applied topically, directly to a patient’s exfoliated skin. The intention of direct supplementation of TGM1 protein at the site of administration is local correction and phenotypic improvement. Like B-VEC, KB105 was designed to be easily administered by a healthcare professional in the doctor’s office or, potentially, at the patient’s home.

The FDA and the EMA have each granted KB105 ODD and Orphan Designation, respectively, for the treatment of TGM1-ARCI, and the FDA has granted KB105 Fast Track Designation and Rare Pediatric Designation for the treatment of TGM1-ARCI.

Clinical Development of KB105

In September 2019, the company initiated a Phase 1/2 trial in TGM1-ARCI patients. In May 2020, initial clinical data from the Phase 1 portion of the study which enrolled adult patients were presented at the Society for Investigative Dermatology (‘SID’) meeting. In August 2020, the company initiated the second phase of its Phase 2 portion of the clinical trial of KB105 to treat ARCI. In July 2021, the company announced initial Phase 2 data.

The company plans to resume enrollment in the Phase 2 portion of this trial later in 2024.

KB104 for Netherton Syndrome

KB104

KB104 is a redosable off-the-shelf gene therapy designed to deliver two copies of the SPINK5 gene to relevant skin cells when applied topically. By directly supplementing the skin with functional SPINK5, the goal of therapy is to locally correct the desquamation and improve the barrier function of the skin. In preclinical testing, a properly localized human SPINK5 gene was detected 48 hours after topical KB104 application in mice without toxicity. KB104-mediated human SPINK5 was expressed in the correct layer of skin at the transcript and protein levels.

The FDA has granted KB104 Rare Pediatric Designation for the treatment of Netherton Syndrome.

The company plans to file an IND application with the FDA and initiate a clinical trial of KB104 in Netherton Syndrome following initiation of the KB105 Phase 2 study.

Aesthetics

While the company’s focus is on the development of gene therapies to treat patients with severe, life-threatening, or rare diseases with high unmet medical needs, the company is also evaluating the potential of the company’s platform to address more prevalent and/or non-genetic conditions. To that end, in April 2019, the company incorporated Jeune Aesthetics, a wholly-owned subsidiary, for the purposes of undertaking preclinical and clinical studies for aesthetic skin conditions.

KB301 for Aesthetic Skin Conditions

KB301

KB301 leverages the company’s clinical experience in delivering genes of interest to the skin and is designed to stimulate biorejuvenation of the skin via delivery of the gene that encodes for type III collagen when administered via intradermal injection. The company’s approach of directed expression of full-length human type III collagen via intradermal application of KB301 provides a unique and straightforward approach to restoring collagen homeostasis, and by extension, reconstructing an optimal physiologic environment in the skin to treat wrinkles or other presentations of aged or damaged skin.

Clinical Development of KB301

The company initiated a Phase 1 clinical trial, the PEARL-1 trial, for the treatment of aesthetic skin conditions in August 2020. The Phase 1 dose-ranging trial evaluated the safety, tolerability, and initial efficacy of intradermal injections of KB301 in adult subjects aged 18-75. KB301 was well tolerated, and the company was able to biopsy and demonstrate proof-of-mechanism. Complete results from Cohort 1 focused on safety were presented at the 2021 SID Annual Meeting.

In March 2022, the company announced positive proof-of-concept efficacy and safety data from Cohort 2 of the PEARL-1 study of KB301 for the treatment of aesthetic skin indications. Cohort 2 was a randomized, double-blind, placebo-controlled clinical trial that evaluated the safety and efficacy of KB301 for the improvement of fine lines and skin texture in the lower and upper cheek and for improvement in skin thickness in the knee. Cohort 2 enrolled 27 subjects across two trial sites. Bilateral treatment areas included the neck behind the ear to assess initial safety and on the cheek below and above the zygomatic arch (lower and upper cheek), and around the knee. Subjects were randomized 2:1 to receive low dose KB301 or placebo in the upper cheek and knee as multiple micro depot injections over the selected treatment area with a 33 G needle. Subjects receiving KB301 in the lower check were randomized 2:1 to receive either low dose KB301, high dose KB301 or placebo. Four patients dropped out of the Cohort 2 study – one subject following the initial safety assessment behind the ear, two subjects for unspecified reasons, and one subject due to unevenness in face between active and placebo during the study.

A subset of subjects from the PEARL-1 Cohort 2 trial were enrolled into a durability trial to look for duration of effect, reduction of the unevenness in placebo treated sites, and for long term safety monitoring. Ten subjects were enrolled in the durability trial, an open-label extension study to assess duration of effect below the zygomatic arch (the lower cheek area). The durability trial enrolled subjects who had received the high dose regimen of KB301 during the PEARL-1 Cohort 2 trial in one or both of their lower cheeks. Subject Satisfaction Scores and Investigator Assessments were measured monthly for three consecutive visits that correspond to timepoints up to nine-months following administration of the last dose of KB301. In addition, subjects with placebo-treated lower cheeks were dosed with KB301 during the durability trial to normalize their appearance. In November 2022, the company announced nine-month durability of effect in Cohort 2 of the PEARL-1 study of KB301.

In April 2023, the company initiated and treated the first subject in the PEARL-1 Cohort 3 study. The PEARL-1 Cohort 3 study is an open label study to evaluate different doses of KB301 for the improvement of lateral canthal lines (‘LCL’) at rest in up to 20 subjects. Jeune Aesthetics initiated and treated the first subject in the PEARL-1 Cohort 4 study in January 2024, an open label study to evaluate KB301 for the improvement of dynamic wrinkles of the decollete in up to 20 subjects. The Cohort 3 and Cohort 4 studies are running simultaneously and Jeune Aesthetics expects to announce results for both cohorts in the first half of 2024. Following completion of these cohorts, Jeune Aesthetics plans to initiate a Phase 2 study of KB301. Details of the Phase 1 study can be found at www.clinicaltrials.gov under NCT identifier NCT04540900. Nothing included on this website shall be deemed incorporated by reference into this Annual Report on Form 10-K.

Future Opportunities

In addition to the programs specified herein, the company is conducting exploratory preclinical research and development to expand potential applications of proprietary HSV-1 based vector platform. Research focus areas include the development of new candidates for the treatment of additional monogenic rare diseases in the skin, lung, and eye, as well as exploration of new routes of administration to treat diseases in additional tissues. The company also believe the ability to redose, as well as the large payload capacity of the company’s proprietary vectors, will allow the company to deliver multiple genes and other effectors, which could enable development of therapies for more common conditions that are not necessarily the result of an inherited genetic defect, such as KB707. As additional proof-of concept the company has generated a library of vectors designed to deliver anti-inflammatory antibodies. Further, the company evaluated one of these vectors in an animal model of atopic dermatitis where expression of the vector-encoded-antibody was confirmed, and efficacy was observed.

Government Regulation and Product Approval

For the therapy, the company is developing that diagnoses based on existing genetic tests developed and administered by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) are sufficient to select appropriate patients and will be permitted by the FDA.

In addition to the foregoing, state and federal laws regarding environmental protection and hazardous substances, including the Occupational Safety and Health Act, the Resource Conservation and Recovery Act, and the Toxic Substances Control Act, affect the company’s business.

History

The company was founded in the state of California in 2016 as Krystal Biotech, LLC. In 2017, the company converted from a limited liability company to a C-corporation in the state of Delaware and changed its name to Krystal Biotech, Inc. It was incorporated in 2017.