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SOL - GEL Sol - Gel Technologies Reports First Quarter 2021 Financial Results and Corporate Update May 13 , 2021 - Sol - Gel is in advanced negotiations with a potential partner regarding the commercialization of EPSOLAY® and TWYNEO® - EPSOLAY PDUFA goal date was set for April 26 , 2021. Awaiting FDA's pre - approval inspection - TWYNEO PDUFA goal date set for August 1 , 2021 NESS ZIONA , Israel , May 13 , 2021 ( GLOBE NEWSWIRE ) -- Sol - Gel Technologies , Ltd. ( NASDAQ : SLGL ) , a clinical - stage dermatology company focused on identifying , developing and commercializing branded and generic topical drug products for the treatment of skin diseases , today announced financial results for the first quarter ended March 31 , 2021 and provided corporate updates . Corporate Highlights and Recent Developments • Sol - Gel is in advanced negotiations with a potential partner regarding the commercialization of EPSOLAY ( benzoyl peroxide , 5 % ) topical cream and TWYNEO ( benzoyl peroxide , 3 % , and tretinoin , 0.1 % ) topical cream . • With the completion of the development of EPSOLAY and TWYNEO and the advanced negotiations with a potential partner regarding their commercialization , Sol - Gel is turning its attention to the development of its next generation of dermatological treatments for unmet medical needs including SGT - 210 , erlotinib and preclinical assets tapinarof and roflumilast . As Mr. Mori Arkin was deeply involved in the origination of these products and is the main inventor on many of their new patents , Sol - Gel's CEO , Dr. Alon Seri - Levy , has requested Mr. Arkin to leverage his vast experience in dermatology on behalf of Sol - Gel and dedicate more time to overseeing the development of the new projects . Sol - Gel is grateful to Mr. Arkin for agreeing to Dr. Seri - Levy's request . The Board of Directors has approved a change in Mr. Arkin's title to Executive Chairman to reflect Mr. Arkin's expanded role at the Company . • In September 2020 , Sol - Gel was informed by the FDA that the PDUFA goal date for EPSOLAY was set for April 26 , 2021 In the most recent written communication with the FDA regarding EPSOLAY , Sol - Gel and the FDA discussed and agreed to the final content of the labeling of the product . On April 27 , 2021 , Sol - Gel received confirmation from the FDA that action on the NDA for EPSOLAY has not yet been taken due to the inability of the FDA to conduct a pre - approval inspection of the production site of EPSOLAY as a result of COVID - 19 travel restrictions . Sol - Gel's contract manufacturer of EPSOLAY is located in North America , outside the USA , and it underwent on - site inspection by the FDA in the first quarter of 2020 . • In December 2020 , Sol - Gel was informed by the FDA that the PDUFA goal date for TWYNEO is set for August 1 , 2021 . Our contract manufacturer of TWYNEO is located outside of North America , and it underwent on - site inspection by the FDA in the fourth quarter of 2019 . • Second generic is expected to be commercialized in the second quarter of this year . Financial Results for the Three Months Ended March 31 , 2021 Revenue in 2021 was $ 0.7million . The revenue was mainly due to sales of a generic product from a collaboration arrangement with Perrigo . Research and development expenses were $ 2.5 million in 2021 compared to $ 7.9 million during the same period in 2020. The decrease of $ 5.4 million was mainly attributed to a decrease of $ 5.1 million in clinical trial expenses related to EPSOLAY and TWYNEO and a decrease of $ 0.5 million in manufacturing expenses . General and administrative expenses were $ 2.5 million in 2021 compared to $ 2.8 million in 2020. The decrease of $ 0.3 million was mainly attributed to a decrease of $ 0.2 million in patent related expenses . Sol - Gel reported a loss of $ 4.1 million for the first quarter of 2021 compared to loss of $ 7.1 million for the same period in 2020 . As of March 31 , 2021 , Sol - Gel had $ 34.2 million in cash , cash equivalents and deposits , and $ 12.8 million in marketable securities for a total balance of $ 47.0 million . Sol - Gel expects its existing cash resources will enable funding of operational and capital expenditure requirements into the third quarter of 2022 . About Sol - Gel Technologies Sol - Gel is a clinical - stage dermatology company focused on identifying , developing and commercializing branded and generic topical drug products for the treatment of skin diseases . Sol - Gel leverages its proprietary microencapsulation technology platform for the development of TWYNEO , under investigation for the treatment of acne vulgaris with an NDA filed with the FDA and a PDUFA goal date set for August 1 , 2021 ; and EPSOLAY , under investigation for the treatment of inflammatory lesions of rosacea with an NDA filed with the FDA and a PDUFA goal date which was set for April 26 , 2021. Action on the NDA for EPSOLAY has not yet been taken due to the inability of the FDA to conduct a pre - approval inspection of the production site of EPSOLAY as a result of COVID - 19 travel restrictions . The Company's pipeline also includes SGT - 210 , an early - stage topical epidermal growth factor receptor inhibitor , erlotinib , under investigation for the treatment of palmoplantar keratoderma , and preclinical assets tapinarof and roflumilast . For additional information , please visit www.sol-gel.com .