PITTSBURGH, Aug. 07, 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 medical needs, today reported financial results and key operational progress updates for the second quarter ended June 30, 2023.
“2023 is off to a very strong start and we expect the momentum to continue for the rest of the year. In the first half of the year, we received FDA approval for VYJUVEK, dosed our first patient in the cystic fibrosis trial and obtained IND clearance for our first oncology candidate,” said Krish S. Krishnan, Chairman and CEO of Krystal Biotech. “I am particularly thrilled with the enthusiasm that physicians and patients are expressing for VYJUVEK in these early days of launch. With 121 Patient Start Forms in the first six weeks since approval, I am pleased with the initial pace of the launch, and we look forward to promptly initiating treatment for these patients.”
VYJUVEKTM
Respiratory
KB407 for the treatment of Cystic Fibrosis (CF)
KB408 for the treatment of Alpha-1 Antitrypsin Deficiency (AATD)
Oncology
KB707 for the treatment of solid tumors
Dermatology
KB105 for the treatment of TGM1 deficient autosomal recessive congenital ichthyosis
KB104 for the treatment of Netherton Syndrome
Aesthetics
KB301 for the treatment of aesthetic indications
Financial results for the quarter ended June 30, 2023:
Financial results for the six months ended June 30, 2023:
About VYJUVEK
VYJUVEK is a non-invasive, topical, redosable gene therapy designed to deliver two copies of the COL7A1 gene when applied directly to DEB wounds. VYJUVEK was designed to treat 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.
Indication
VYJUVEK is a herpes-simplex virus type 1 (HSV-1) vector-based gene therapy indicated for the treatment of wounds in patients six months of age and older with dystrophic epidermolysis bullosa with mutation(s) in the collagen type VII alpha 1 chain (COL7A1) gene.
IMPORTANT SAFETY INFORMATION
Adverse Reactions
The most common adverse drug reactions (incidence >5%) were itching, chills, redness, rash, cough, and runny nose. These are not all the possible side effects with VYJUVEK. Call your healthcare provider for medical advice about side effects.
To report SUSPECTED ADVERSE REACTIONS, contact Krystal Biotech, Inc. at 1-844-557-9782 or FDA at 1-800-FDA-1088 or https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program.
Contraindications
None.
Warnings and Precautions
VYJUVEK gel must be applied by a healthcare provider.
After treatment, patients and caregivers should be careful not to touch treated wounds and dressings for 24 hours.
Wash hands and wear protective gloves when changing wound dressings. Disinfect bandages from the first dressing change with a virucidal agent, and dispose of the disinfected bandages in a separate sealed plastic bag in household waste. Dispose of the subsequent used dressings in a sealed plastic bag in household waste.
Patients should avoid touching or scratching wound sites or wound dressings.
In the event of an accidental exposure flush with clean water for at least 15 minutes.
For more information, see full U.S. Prescribing Information.
About Fast Track Designation
Fast Track Designation is designed to facilitate the development and expedite the review of drugs to treat serious conditions and treat a serious or unmet medical need, enabling drugs to reach patients sooner. Clinical programs with Fast Track designation may benefit from early and frequent communication with the FDA throughout the regulatory review process, and such clinical programs may be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.
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. VYJUVEKTM is the Company’s first commercial product, the first-ever redosable gene therapy, and the only 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 Twitter.
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 develop products to fundamentally address – and reverse – the biology of aging and/or damaged skin. For more information, please visit http://www.jeuneinc.com.
Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Krystal Biotech, Inc. or Jeune Aesthetics, Inc., including statements about our commercial launch of VYJUVEK; our plans to report on Patient Start Forms and Patients on Therapy; our plans to submit a market authorization application to the EMA in the second half of 2023 and our anticipation of a potential launch of B-VEC in the EU in the second half of 2024; our plans for an open label extension study of B-VEC in Japan in the second half of 2023, filing for approval in Japan in 2024, and the timing of our provision of details of the open label extension study; our expectation that we will announce data from the Phase 1 study of KB407 in 2024; our intention to file an IND application with the FDA and initiate a Phase 1 clinical trial of KB408 for the treatment of AATD in the second half of 2023; our expectations regarding dosing the first patient with KB707 in the second half of 2023; our plans to file an amendment to the existing KB707 IND in the second half of 2023 to evaluate inhaled KB707 in a clinical trial in the first half 2024; our plans to initiate the Phase 2 cohort of the KB105-02 (JADE-1) trial in 2024; our plans to file an IND application and initiate a clinical trial of KB104 in late 2024; our expectation that we will announce results of the Phase 1, Cohort 3 study of KB301 for the improvement of lateral canthal lines at rest in the second half of 2023, 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 and applications for marketing approvals, the availability or commercial potential of product candidates including VYJUVEK, the sufficiency of cash resources and need for additional financing and such other important factors as are set forth under the caption “Risk Factors” in the Company’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 the Company’s views as of the date of this release. The Company anticipates that subsequent events and developments will cause its views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this release.
Disclosures
The Company is using the Aerogen Solo® Nebulizer System and Aerogen® Ultra in its Phase 1 CORAL-1/U.S. study evaluating KB407.
CONTACT:
Investors and Media:
Meg Dodge
Krystal Biotech
This email address is being protected from spambots. You need JavaScript enabled to view it.
Consolidated Balance Sheet Data:
(In thousands) | June 30, 2023 | December 31, 2022 | ||||
Balance sheet data: | ||||||
Cash and cash equivalents | $ | 275,875 | $ | 161,900 | ||
Short-term investments | 201,642 | 217,271 | ||||
Long-term investments | 28,410 | 4,621 | ||||
Total assets | 684,026 | 558,450 | ||||
Total liabilities | 30,912 | 36,219 | ||||
Total stockholders’ equity | $ | 653,114 | $ | 522,231 |
Consolidated Statements of Operations:
Three Months Ended June 30, | |||||||||||
(In thousands, except shares and per share data) | 2023 | 2022 | Change | ||||||||
Expenses | |||||||||||
Research and development | $ | 12,144 | $ | 10,890 | $ | 1,254 | |||||
General and administrative | 25,904 | 17,863 | 8,041 | ||||||||
Total operating expenses | 38,048 | 28,753 | 9,295 | ||||||||
Loss from operations | (38,048 | ) | (28,753 | ) | (9,295 | ) | |||||
Other Income | |||||||||||
Interest and other income, net | 4,838 | 645 | 4,193 | ||||||||
Net loss | $ | (33,210 | ) | $ | (28,108 | ) | $ | (5,102 | ) | ||
Net loss per common share: Basic and diluted | $ | (1.25 | ) | $ | (1.10 | ) | |||||
Weighted-average common shares outstanding: Basic and diluted | 26,656,883 | 25,545,167 |
Six Months Ended June 30, | |||||||||||
2023 | 2022 | Change | |||||||||
(In thousands) | (unaudited) | ||||||||||
Expenses | |||||||||||
Research and development | $ | 24,432 | $ | 20,204 | $ | 4,228 | |||||
General and administrative | 49,939 | 33,771 | 16,168 | ||||||||
Litigation settlement | 12,500 | 25,000 | (12,500 | ) | |||||||
Total operating expenses | 86,871 | 78,975 | 7,896 | ||||||||
Loss from operations | (86,871 | ) | (78,975 | ) | (7,896 | ) | |||||
Other Income | |||||||||||
Interest and other income, net | 8,364 | 902 | 7,462 | ||||||||
Net loss | $ | (78,507 | ) | $ | (78,073 | ) | $ | (434 | ) | ||
Net loss per common share: Basic and diluted | $ | (3.00 | ) | $ | (3.08 | ) | |||||
Weighted-average common shares outstanding: Basic and diluted | 26,187,161 | 25,331,000 |
Last Trade: | US$184.19 |
Daily Change: | -1.87 -1.01 |
Daily Volume: | 86,190 |
Market Cap: | US$5.290B |
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