For the completed multidose clinical studies in ALS and PMS, the Company has improved the efficiency of NurOwn® production and improved its stability, allowing manufacturing to take place at centralized clean room facilities from which NurOwn® is distributed to the clinical trial sites, where the cells are then administered to patients. The Company is also engaged in several research initiatives to further improve and scale-up manufacturing capacity and extend the shelf life of NurOwn®.
Corporate Information
We are incorporated under the laws of the State of Delaware. Our principal executive offices are located at 1325 Avenue of Americas, 28th Floor, New York, NY 10019, and our telephone number is (201) 488-0460. We also maintain an office in Petach Tikva, Israel. We maintain a website at http://www.brainstorm-cell.com. The information on our website is not incorporated into this Quarterly Report on Form 10-Q.
Results of Operations
For the period from inception (September 22, 2000) until June 30, 2022, we did not generate any revenues from operations. In addition, we incurred operating costs and expenses of approximately $7,591,000 during the three months ended June 30, 2022, compared to $6,121,000 during the three months ended June 30, 2021. We incurred operating costs and expenses of approximately $13,066,000 during the six months ended June 30, 2022, compared to $13,050,000 during the six months ended June 30, 2021.
Research and Development, net
Our business model calls for significant investments in research and development. Our research and development expenditures, net in the three months ended June 30, 2022 were $5,113,000, an increase of $1,514,000 compared to $3,599,000 for the three months ended in June 30, 2021.
This increase is due to: (i) an increase of $1,416,000 in costs related to the EAP and commercial preparation expenses from $1,665,000 in three months ended June 30, 2021 to $3,081,000 for the three months period ended June 30, 2022; (ii) an increase of $391,000 in connection with materials, travel, depreciation, rent and other activities and (iii) a decrease of $214,000 in participation of the Israel Innovation Authority (“IIA”) and under various awarded grants in 2022. This increase was partially offset by (i) a decrease of $417,000 for costs related to stock-based compensation expenses and payroll and (ii) a decrease of $90,000 in connection with consultants, patents and other costs. Excluding participation from IIA and other grants, research and development expenses in the three months ended June 30, 2022 were $5,113,000, an increase of $1,300,000 compared to $3,813,000 for the three months ended in June 30, 2021.
Our research and development expenditures, net in the six months ended June 30, 2022 were $7,729,000, a decrease of $211,000 compared to $7,940,000 for the six months ended in June 30, 2021.
This decrease is due to: (i) a decrease of $1,123,000 in costs related to the Phase 3 and Phase 2 Clinical Trials from $4,728,000 in six months ended June 30, 2021 to $3,605,000 for the six months period ended June 30, 2022; (ii) and decrease of $385,000 in connection with payroll expenses, consultants, patents and other activities from $3,272,000 in six months ended June 30, 2021 to $2,887,000 for the six months period ended June 30, 2022 This decrease was partially offset by (i) an increase of $948,000 for costs related to stock-based compensation expenses, materials, depreciation, travel, rent and other activities and (ii) a decrease of $349,000 in participation of the Israel Innovation Authority (“IIA”).
General and Administrative
General and administrative expenses for the three months ended June 30, 2022 and 2021 were $2,478,000 and $2,522,000, respectively. The decrease in general and administrative expenses of $44,000 is primarily due to a decrease in payroll and other costs.
General and administrative expenses for the six months ended June 30, 2022 and 2021 were $5,337,000 and $5,110,000, respectively. The increase in general and administrative expenses of $227,000 is primarily due to increase for costs related to stock-based compensation expenses, consultants, PR activities, travel, rent and other activities. This increase was partially offset by a decrease in payroll cost.