Information and analysis earlier than you hear about it on CNBC and others. Declare your 1-week free trial to StreetInsider Premium here.
PainReform Ltd. (Nasdaq: PRFX) (“PainReform” or the “Firm”), a medical stage specialty pharmaceutical firm centered on the reformulation of established therapeutics, in the present day offered a year-end enterprise replace.
Vital occasions and achievements throughout the fourth quarter 2020 and subsequent interval:
- Preparation for the primary Section 3 medical trial, for sufferers present process bunionectomy surgical procedure, is anticipated to start by mid-2021
- Introduced the engagement of Lotus Scientific Analysis because the Firm’s medical analysis group to conduct the Section 3 medical trials beneath the management of Dr. Neil Singla
- Introduced the appointment of Rita Keynan as Vice President of Pharmaceutical Operations
- Signed a producing companies and high quality settlement with a subcontractor for GMP manufacturing of medical trial batches of PRF-110
- Continued to construct the patent property, which now consists of fourteen issued patents all over the world, the earliest of which don’t expire till 2033
- Introduced a $6 million personal placement, anticipated to supply funding into Q2 2022
Ilan Hadar, Chief Govt Officer of PainReform, commented, “We’re making fast progress in direction of commencing our Section 3 medical trials of PRF-110. Our first deliberate trial is for bunionectomy surgical procedure. On the heels of the bunionectomy trial, we plan to start our second Section 3 trial for the therapy of hernia. As well as, we lately introduced the appointment of Lotus Scientific Analysis as our medical analysis group to conduct the 2 medical trials beneath the management of Dr. Neil Singla, one of many preeminent consultants in analgesic protocol design. We additionally lately introduced the appointment of Rita Keynan as Vice President of Pharmaceutical Operations, who brings over 25 years of expertise within the pharmaceutical trade and will likely be an necessary addition to the group as we put together to start our Section 3 pivotal trials for PRF-110. Most lately, we signed a producing companies and high quality settlement with a subcontractor for manufacturing of concerning GMP manufacturing medical trial batches of PRF-110.”
Mr. Hadar concluded, “I’m excited concerning the outlook for 2021 and look ahead to numerous key upcoming catalysts that we consider will additional improve shareholders’ worth, together with the beginning of enrolment and dosing of the primary sufferers. Provided that we have been granted 505(b)(2) pathway by the FDA, I count on this to be a fast and value environment friendly trial. With the completion of our latest personal placement, we now have a money runway of greater than 12 months, which we count on will take us via numerous necessary key milestones, together with completion of our first Section 3 trial and reporting its top-line information.”
Monetary Outcomes for the 12 months Ended December 31, 2020
Analysis and growth bills for the yr ended December 31, 2020 have been $354,000 a rise of $218,000, or 160% increased, in comparison with $136,000 for the prior yr. The rise resulted primarily as a result of the preparations related to the Firm’s deliberate Section 3 trials.
Common and administrative bills for the yr ended December 31, 2020 have been $1.3 million, a rise of $764,000, or 138% in comparison with $553,000 for the prior yr. The rise is primarily a results of the rise in skilled companies bills, public firm D&O insurance coverage premiums and enhance in payroll bills associated to the hiring, put up IPO of extra administration.
Working loss for the yr ended December 31, 2020 amounted to $1.7 million, in comparison with $689,000 for the yr ended December 31, 2019.
Internet monetary bills amounted to $2.2 million for the yr ended December 31, 2020, in comparison with $590,000 for the yr ended December 31, 2019. The rise is primarily because of the enhance in curiosity expense, amortization of the low cost on convertible notes and enhance in bills associated to the change within the honest worth of spinoff warrant legal responsibility.
The Firm’s web loss for the yr ended December 31, 2020 amounted was $4.1 million, in comparison with $1.3 million for the prior yr.
The Firm had $15.7 million in money and money equivalents as of December 31, 2020. As well as, on March 11, 2021, the Firm closed a $6.0 million personal placement, earlier than placement agent charges and bills. The Firm believes that its money and money equivalents as of December 31, 2020, plus the web proceeds from the personal placement will fund working bills and capital expenditure necessities into the second quarter of 2022.
Internet money utilized in working actions for the yr ended December 31, 2020 was $2.6 million, in comparison with $609,000 for the yr earlier than.
Internet money offered by financing actions for the yr ended December 31, 2020 was $17.3 million, in comparison with $1.5 million for the prior yr. The money flows in 2020 primarily mirror web proceeds obtained from the Firm’s IPO on the Nasdaq Capital Market. The money flows in 2019 primarily mirror the web proceeds from issuance of convertible notes.
Extra detailed data will be discovered within the Firm’s Annual Report on Type 20-F, a duplicate of which has been filed with the Securities and Change Fee and posted on the Firm’s web site at www.painreform.com. It’s possible you’ll request a duplicate of the Firm’s Type 20-F, for free of charge to you, by writing to the Chief Monetary Officer of the Firm at 4 Bruria Avenue, Tel Aviv, Israel, 6745442 or by calling +972-3-717-7051.
PainReform is a clinical-stage specialty pharmaceutical firm centered on the reformulation of established therapeutics. PRF-110, the Firm’s lead product, is predicated on the native anesthetic ropivacaine, focusing on the post-operative ache reduction market. PRF-110 is an oil-based, viscous, clear answer that’s deposited instantly into the surgical wound mattress previous to closure to supply localized and prolonged post-operative analgesia. The Firm’s proprietary extended-release drug-delivery system is designed to supply an prolonged interval of post-surgical ache reduction with out the necessity for repeated dose administration whereas decreasing the potential want for the usage of opiates.