PITTSBURGH - Krystal Biotech , Inc. (NASDAQ: NASDAQ:KRYS), a biotechnology company in the commercial stage valued at $4.86 billion, has released initial clinical results from its KYANITE-1 study, which is examining the effects of inhaled KB707 on patients with solid tumors in the lungs. The company maintains an impressive "GREAT" financial health rating according to InvestingPro analysis, with strong cash flow and growth metrics. The study showed an objective response rate (ORR) of 27% and a disease control rate (DCR) of 73% in patients with advanced non-small cell lung cancer (NSCLC) who have progressed after standard treatments.
The KYANITE-1 study is an open-label, multicenter trial with a focus on safety, tolerability, and tumor response, following RECIST v1.1 criteria. The trial involves administering KB707 once weekly for the first three weeks, followed by once every three weeks. As of December 6, 2024, 37 patients have received at least one dose of KB707, with 17 having advanced NSCLC.
Dr. Wen Wee Ma of the Cleveland Clinic noted the inhaled delivery method as innovative, emphasizing its potential benefit as a monotherapy in NSCLC patients. The treatment has been well tolerated and is suitable for outpatient settings, showing no Grade 4 or 5 adverse events.
The company has observed clinical activity, particularly in patients with advanced NSCLC, where out of 11 evaluable patients, three partial responses were recorded, and seven remained on treatment. Treatment responses in lung lesions were notable, with an ORR of 36% in target lung lesions. This clinical progress comes as Krystal demonstrates remarkable commercial execution, achieving a 92.55% gross profit margin and experiencing substantial revenue growth in the last twelve months. InvestingPro subscribers can access 15+ additional key metrics and insights about KRYS's financial performance.
Krystal Biotech has amended the KYANITE-1 protocol to explore KB707 in combination with anti-PD-1 therapy, with or without chemotherapy, for advanced NSCLC. No patients have yet been enrolled in these new cohorts.
The company plans to present detailed and updated results from the KYANITE-1 study at future scientific conferences. With analysts maintaining a strong buy consensus and setting price targets up to $221, investors seeking deeper insights can access the comprehensive Pro Research Report available on InvestingPro, which provides detailed analysis of KRYS's valuation, growth prospects, and peer comparison. The information in this article is based on a press release statement from Krystal Biotech.
In other recent news, Krystal Biotech has been making significant strides in its operations and financials. The company reported a substantial rise in earnings per share in Q3 2024, moving from $0.54 in Q2 to $0.95, driven primarily by robust revenue growth from its lead product, VYJUVEK, which generated net revenues of $83.8 million in Q3. BofA Securities maintained a Buy rating on the company, underlining the potential of its product candidates KB407 and KB408, currently under development for cystic fibrosis and alpha-1 antitrypsin deficiency respectively.
Krystal Biotech also announced plans to expand into Europe and Japan, with the anticipated launch of its gene therapy product, B-VEC, in both regions in 2025. This aligns with the company's expectation of receiving an opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in the first quarter of 2025. The company is also advancing its clinical pipeline, with interim data readouts expected by the end of 2024 from multiple products.
Financially, Krystal Biotech reported a robust position, with $374 million in cash and investments at the end of Q3 2024, and anticipates reaching a $300 million milestone payment related to the PeriphaGen settlement in early 2025. These developments are part of Krystal Biotech's ongoing efforts to diversify and expand its operations, as noted by BofA Securities.
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