Business
PainReform Provides Business Update for the Third Quarter of 2021
Reports continued progress towards commencing Phase 3 clinical trials Announces Selection of Pharmaceutics International, Inc. as U.S. Manufacturer of PRF-110
About this update from Prf Technologies Ltd.
[{"type":"text","content":"Reports continued progress towards commencing Phase 3 clinical trials Announces Selection of Pharmaceutics International, Inc. as U.S. Manufacturer of PRF-110 for Upcoming Phase 3 Trial TEL AVIV, Israel, Nov. 16, 2021 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) (\"PainReform\" or the \"Company\"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today provided a business update for the third quarter ended September 30, 2021. Ilan Hadar, Chief Executive Officer, stated, \"We are continuing to progress towards the commencement of our Phase 3 clinical trials of PRF-110, our lead product, based on the local anesthetic ropivacaine, targeting the post-operative pain relief market. Towards this end, we have engaged Pharmaceutics International, Inc. (PI), a US based contract manufacturing organization (CMO) for the purpose of manufacturing our clinical batches. PI is a premier, CMO with over 25 years of experience in cGMP manufacturing services to the global biopharmaceutical industry. We now expect to commence our first clinical trial in bunionectomy by the second half of 2022. Moreover, upon completion of the bunionectomy trial, we plan to initiate the Phase 3 hernia repair clinical trial.” “We have maintained a solid balance sheet with $18.4 million of cash on hand at the end of the third quarter. With the recent exercise of warrants, we now have a cash runway of more than 12 months, which we expect will take us through a number of important key milestones, including initiation of our first Phase 3 trial” concluded Mr. Hadar. Financial Results Research and development expenses were $2.3 million for the nine months ended September 30, 2021 compared to $92,000 for the nine months ended September 30, 2020, an increase of $2.2 million. The increase was primarily due to an increase in chemistry and manufacturing controls (CMC) activities and preparation for the initiation of clinical trials. General and administrative expenses were $3.2 million for the nine months ended September 30, 2021 compared to $888,000 for the nine months ended September 30, 2020, an increase of $2.3 million. The increase was primarily due to costs related with us becoming a publicly traded company commencing September 2020, an increase in headcount related costs and an increase in certain profession...