Krystal Biotech Reports Q1 2019 Financial Results and Provides Corporate Update

5/6/19

PITTSBURGH, May 06, 2019 (GLOBE NEWSWIRE) -- Krystal Biotech Inc., (NASDAQ: KRYS), a gene therapy company developing medicines to treat dermatological diseases, announced financial results for first quarter 2019 and an update on its business progress.

“We are very pleased to have KB103 accepted into the PRIME program and believe that KB103 could potentially be a transformative treatment option for patients with dystrophic epidermolysis bullosa,” said Krish S. Krishnan, chairman and chief executive officer. “Data to be presented at SID will demonstrate the pipeline potential of our platform technology as we look to file an IND on KB105 for the treatment of autosomal recessive congenital ichthyosis and initiate Phase 1/2 clinical trials in the second half of 2019. We remain steadfast in our goal to commence pivotal trials on KB103 in the second half of 2019 and make our gene therapy available as quickly and safely as possible for families suffering from DEB.”

Recent Corporate Highlights

  • On April 29, 2019, we announced five presentations of clinical and preclinical data at the upcoming Society for Investigative Dermatology annual meeting on May 9, 2019 in Chicago.
  • On March 29, 2019, the European Medicines Agency (EMA) granted PRIME eligibility for KB103 to treat dystrophic epidermolysis bullosa. The PRIME scheme was established by the EMA to enhance support for the development of medicines that target unmet medical needs, with the goals of optimizing development plans and speeding up evaluation so these medicines can potentially reach patients earlier.
  • On March 5, 2019, we had the official inauguration of Ancoris, our commercial scale cGMP-compliant manufacturing facility, following completion of a manufacturing trial run of KB103.

Financial results for the quarter ended March 31, 2019

  • Cash, cash equivalents and short-term investments totaled $106.6 million on March 31, 2019.
  • Research and development expenses for the first quarter ended March 31, 2019 were $3.2 million, compared to $1.5 million for first quarter 2018.
  • General and administrative expenses for the first quarter ended March 31, 2019 were $1.5 million, compared to $0.8 million for first quarter 2018.
  • Net losses for the quarters ended March 31, 2019 and 2018 were $4.1 million and $2.2 million or ($0.29) and ($0.21) per common share (basic and diluted), respectively.

For additional information on the Company’s financial results for the year ended December 31, 2018, refer to form 10K filed with the SEC.


About KB103

KB103 is Krystal’s lead product candidate, currently in clinical development and seeks to use gene therapy to treat dystrophic epidermolysis bullosa, or DEB, an incurable skin blistering condition caused by a lack of collagen in the skin. KB103 is a replication-defective, non-integrating viral vector that has been engineered using the HSV-1 virus employing Krystal’s STAR-D platform to deliver functional human COL7A1 genes directly to the patients’ dividing and non-dividing skin cells. Krystal’s vector can penetrate skin cells more efficiently than other viral vectors. Its high payload capacity allows it to accommodate large or multiple genes and its low immunogenicity makes it a suitable choice for direct and repeat delivery to the skin.