Krystal Biotech Reports First Quarter 2021 Financial Results and Provides Update on Operational Progress
Completed enrollment in pivotal GEM-3 study of B-VEC in dystrophic epidermolysis bullosa (DEB)
Strong balance sheet with
“This year has already been, and will continue to be, a busy period for Krystal and I would like to thank our employees for their commitment, passion and resiliency during a global pandemic,” said
Program Highlights & Upcoming Events:
B-VEC for DEB
- During the first quarter, the Company completed enrollment in the ongoing pivotal GEM-3 trial and finalized the statistical analysis plan (SAP) based on feedback from the FDA.
- Topline data from the study is anticipated in 4Q21.
- Details of the pivotal Phase 3 study can be found at www.clinicaltrials.gov under NCT identifier NCT04491604.
KB105 for TGM1-ARCI
- The Company is on track to provide an update on this program in 1H21. The update will consist of safety, TGM1 expression level and efficacy data from the 4th patient enrolled. Data from this patient, together with the data from the three initial patients will help determine next steps.
- Details of the Phase 1/2 study can be found at www.clinicaltrials.gov under NCT identifier NCT04047732.
KB407 for Cystic Fibrosis
April 2021, the Company announced data from the GLP toxicology and biodistribution study which demonstrated in vivo safety of repeat, nebulized doses of KB407 in nonhuman primates. More detailed data will be presented at a future scientific conference.
- The Company intends to initiate a Phase 1 study of KB407 in 3Q21.
KB408 for Alpha-1 Antitrypsin Deficiency
April 2021, Krystal announced initial positive proof-of-concept data from preclinical studies of KB408 in mice. Additional preclinical studies are ongoing, and more detailed data will be presented at a future scientific conference.
KB301 for Aesthetic Indications
May 2021, detailed safety data from the first cohort in the ongoing Phase 1 study of KB301 for aesthetic skin indications was presented at the Society of Investigative Dermatology(SID) Annual Meeting.
- Initial efficacy data from the Phase 1 study is anticipated in 2H21.
KB104 for Netherton Syndrome
- The Company continues to work towards an IND filing, which is anticipated in 2H21.
May 2021, the Company announced the appointment of Andy Orthas Chief Commercial Officer. Mr. Orthhas more than 25 years of global biotechnology experience, most recently in the role of Senior Vice President, Head of US Business at Alnylam Pharmaceuticals.
March 2021, the Company announced the appointment of Dr. Bhuhsan Hardas, M.D., MBA as President of Jeune, Inc.the Company’s wholly owned subsidiary that is leveraging Krystal’s clinically validated gene delivery platform to fundamentally address – and reverse – the biology of aging and/or damaged skin. Before joining Jeune, Dr. Hardasserved as Chief Scientific Officer, Executive Vice President, Global Head of Licensing at Almirall and previously served as Chief Medical Officer of Allergan's Dermatology and Medical Aesthetics business.
February 2021, the Company completed a public offering of 2,211,538 shares of its common stock, including 288,461 shares purchased by the underwriters, at $65.00per share. Net proceeds to the Company from the offering were $134.9 million.
January 2021, 262,500 shares of common stock were issued pursuant to our at-the-market equity offering program ("ATM Program") for net proceeds of $16.9 million, resulting in a remaining $132.5 million available for issuance under the ATM Program. The Company also incurred $172 thousand of other offering expenses related to the ATM Program.
Financial results for the quarter ended
- Cash, cash equivalents and short-term investments totaled
$403.4 millionon March 31, 2021.
- Research and development expenses for the first quarter ended
March 31, 2021were $6.2 million, compared to $3.5 millionfor the first quarter 2020.
- General and administrative expenses for the first quarter ended
March 31, 2021were $8.2 million, compared to $2.4 millionfor first quarter 2020.
- Net losses for the quarters ended
March 31, 2021and 2020 were $15.8 millionand $5.3 million, or $(0.74)and $(0.31)respectively, per common share (basic and diluted).
- For additional information on the Company’s financial results for the first quarter ended
March 31, 2021, refer to form 10-Q filed with the SEC.
Any statements in this press release about future expectations, plans and prospects for
Consolidated Balance Sheet Data:
|Balance sheet data:|
|Cash and cash equivalents||$||402,172||$||268,269|
|Total stockholders’ equity||$||430,652||$||292,084|
Consolidated Statement of Operations:
|Three Months Ended
|(In thousands, except shares and per share data)||2021||2020||Change|
|Research and development||$||6,201||$||3,525||$||2,676|
|General and administrative||8,152||2,421||5,731|
|Total operating expenses||14,353||5,946||8,407|
|Loss from operations||(14,353||)||(5,946||)||(8,407||)|
|Other Income (Expense)|
|Interest and other income, net||33||605||(572||)|
|Build to suit interest expense||(1,492||)||—||(1,492||)|
|Total other income (expense)||(1,459||)||605||(2,064||)|
|Net loss applicable to stockholders||$||(15,812||)||$||(5,341||)||$||(10,471||)|
|Net loss attributable to common stockholders
per share: Basic and diluted
|Weighted-average common shares
outstanding: Basic and diluted
Source: Krystal Biotech, Inc.