HERZLIYA, Israel – May 13, 2021 – 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 first quarter ended March 31, 2021. The Company also announces it has finalized the protocol for its Phase 3 clinical trials of PRF-110 for the treatment of patients undergoing bunionectomy surgery for submission to the regulatory authorities.
Ilan Hadar, Chief Executive Officer of PainReform, commented, “We continue to make progress towards commencing our Phase 3 clinical trials of PRF-110. Towards this end, we have been manufacturing clinical trial batches of PRF-110 in preparation for the Phase 3 clinical trials and are working to address delays due to our CMC partner. We currently expect to commence our bunionectomy Phase 3 clinical trial toward the end of the third quarter of this year. We also hired a new head of clinical operations, which follows the appointment of Lotus Clinical Research as our clinical research organization to oversee the two clinical trials in patients undergoing bunionectomy and hernia repair operations.”
Mr. Hadar continued, “Assuming our Phase 3 clinical trials are successful, we believe PRF-110 will address an important unmet need in the market, especially as an alternative to systemic opioids, which have contributed to the opioid epidemic. Moreover, we have maintained a strong balance sheet, with cash and cash equivalents of $19.4 million as of March 31, 2021, which we believe should be more than sufficient to support our ongoing activities beyond completion of our first Phase 3 trial and reporting top-line data.”
“Marjorie D. Tamblyn, our new head of clinical operations in the U.S., brings over 20 years of experience in clinical operations leadership in the pharmaceutical/biotech and Clinical Research Organization industry and will be an important addition to the team as we advance our clinical trials and begin preparations for commercial activities. Her skill sets and leadership skills should be invaluable as we work towards our goal of establishing PRF-110 as the standard of care in the post-operative non-opiate pain treatment market. We remain highly encouraged by our prior data, which demonstrated a strong safety profile, suggesting a substantial advantage to using PRF-110 over the local anesthetic, ropivacaine.”
Financial Results for the First Quarter Ended March 31, 2021
Research and development expenses were $1,029,000 for the three months ended March 31, 2021 compared to $24,000 for the three months ended March 31, 2020, an increase of $1,005,000. The increase was primarily due to an increase in CMC activities and preparation for the initiation of clinical trials.
General and administrative expenses were $1,010,000 for the three months ended March 31, 2021 compared to $108,000 for the three months ended March 31, 2020, an increase of $902,000 or 835%. 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 professional services costs.
Financial expense, net was $2,000 for the three months ended March 31, 2021 compared to financial expenses, net of $1,164,000 for the three months ended March 31, 2020, a decrease of $1,162,000. The decrease was primarily due to a decrease in change in fair value of derivative warrant liability, and interest expense and amortization of discount on convertible notes.
As a result of the foregoing, the Company incurred a net loss of $2,041,000 for the three months ended March 31, 2021 compared to a net loss of $1,296,000 for the three months ended March 31, 2020, an increase of $745,000 or 57%.
As of March 31, 2021, the Company had cash and cash equivalents of $19,424,000.
PainReform is a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics. PRF-110, the Company’s lead product, is based on the local anesthetic ropivacaine, targeting the post-operative pain relief market. PRF-110 is an oil-based, viscous, clear solution that is deposited directly into the surgical wound bed prior to closure to provide localized and extended post-operative analgesia. The Company’s proprietary extended-release drug-delivery system is designed to provide an extended period of post-surgical pain relief without the need for repeated dose administration while reducing the potential need for the use of opiates.
Notice Regarding Forward-Looking Statements
This press release contains forward looking statements about our expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. These forward-looking statements are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and we undertake no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of our control. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward- looking statements, including, but not limited to, the following: our history of significant losses, our need to raise additional capital and our ability to obtain additional capital on acceptable terms, or at all; our dependence on the success of our initial product candidate, PRF-110; the outcomes of preclinical studies, clinical trials and other research regarding PRF-110 and future product candidates; the impact of the COVID-19 pandemic on our operations; our limited experience managing clinical trials; our ability to retain key personnel and recruit additional employees; our reliance on third parties for the conduct of clinical trials, product manufacturing and development; the impact of competition and new technologies; our ability to comply with regulatory requirements relating to the development and marketing of our product candidates; commercial success and market acceptance of our product candidates; our ability to establish sales and marketing capabilities or enter into agreements with third parties and our reliance on third party distributors and resellers; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights and our ability to operate our business without infringing the intellectual property rights of others; the overall global economic environment; our ability to develop an active trading market for our ordinary shares and whether the market price of our ordinary shares is volatile; and statements as to the impact of the political and security situation in Israel on our business. More detailed information about the risks and uncertainties affecting us is contained under the heading “Risk Factors” included in the Company’s most recent Annual Report on Form 20-F and in other filings that we have made and may make with the Securities and Exchange Commission in the future.
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Chief Executive Officer