PainReform Provides Q2 Business Update
On track to begin Phase 3 bunion clinical trial in Q4 2022
Complete technology transfer to CMO for clinical batch manufacturing
TEL AVIV, Israel, Aug. 16, 2022 (GLOBE NEWSWIRE) — PainReform Ltd. (Nasdaq: PRFX) (“pain reform“or the”Company“), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutic products, today provided a business update for the second quarter ended June 30, 2022.
Ilan Hadar, President and CEO of Pain Reform, said, “We are pleased to report continued progress in advancing PRF-110, our lead product, based on the local anesthetic ropivacaine, which is designed to provide a prolonged period of post-surgical pain relief. without the need for repeated doses, while reducing the potential need to use opioids. Importantly, the manufacturing technology transfer to our CMO, which we engaged to manufacture our clinical batches of PRF-110, was successful and we are in the process of manufacturing the clinical trial material. To that end, we remain on track to commence the U.S. Phase 3 clinical trial of PRF-110 in bunionectomy in the fourth quarter of 2022. Additionally, we have implemented process technology related milestones which we believe will make the manufacturing of PRF-110 much more efficient. efficient. As a result, manufacturing is progressing and we expect to complete manufacturing of the clinical batch by the end of this month. »
“We remain very encouraged by our earlier data, which demonstrated a strong safety profile, suggesting a substantial benefit to the use of PRF-110 over the local anesthetic, ropivacaine. Additionally, upon completion of the bunionectomy trial, we plan to initiate the phase 3 hernia trial. Overall, we are pleased with the outlook for the remainder of 2022 and look forward to a number of key milestones ahead that we believe will further improve shareholder value, including the start of recruitment and the mix of first patients. We have maintained a strong balance sheet and had $13.8 million in cash and no debt as of June 30, 2022. As a result, we have more than sufficient capital to support our ongoing operations beyond the launch of our first phase 3 trial,” concluded Hadar.
“Overall, we remain very encouraged by the company’s prospects. There are over 50 million surgeries performed each year in the United States in hospitals and outpatient surgery centers, many of these invasive and painful procedures can be treated with extended-release ropivacaine through our product , PRF-110. Given that approximately 99% of surgeries today are treated with opioids, and our proprietary sustained-release drug delivery system has broad potential in a wide range of surgeries, we believe we are well positioned in the 12 billion dollar post-operative pain relief market. Additionally, we believe that PRF-110 will significantly prolong post-operative analgesia and be significantly less expensive to produce than current alternatives.
Financial results for the six months ended June 30, 2022
Research and development expenses were $1.4 million for the six months ended June 30, 2022, compared to $1.7 million for the six months ended June 30, 2021, a decrease of $0.3 million. dollars. The decrease is mainly due to lower payments to contractors and clinical trial costs.
General and administrative expenses were $2.1 million for the six months ended June 30, 2022, compared to $2.0 million for the six months ended June 30, 2021. An increase in headcount costs and regulation was offset by lower costs for insurance and certain professional services. costs.
Finance expense, net, was negligible for the six months ended June 30, 2022 compared to finance expense, net of $43,000 for the six months ended June 30, 2021, a decrease of $43,000. The decrease is mainly due to changes in foreign exchange costs.
As a result of the above, the Company incurred a net loss of $3.5 million for the six months ended June 30, 2022, compared to a net loss of $3.7 million for the six months ended June 30, 2021 , a decrease of $0.2 million.
As of June 30, 2022, the Company had cash and cash equivalents of $13.8 million.
PainReform is a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics. PRF-110, the Company’s flagship product, is based on the local anesthetic ropivacaine, targeting the post-operative pain relief market. PRF-110 is a clear viscous oil-based solution that is deposited directly into the surgical wound bed prior to closure to provide localized and prolonged postoperative 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 repeat doses while reducing the potential need to use opiates. For more information, visit www.painreform.com.
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”, “could”, “seek”, “target”, “will”, “project”, “anticipate”, “continue” or “anticipate” or their negative forms or variants of these words or other comparable words or by the fact that such statements do not relate strictly to historical matters.These forward-looking statements are based on assumptions and assessments made in light of experience and management’s perception of historical trends, current conditions, expected future developments and other factors deemed appropriate.The forward-looking statements contained in this press release are made as of the date of this press release, and we undertake no obligation to update or revise such statements, whether as of further news rations, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are beyond our control. Many factors could cause our actual operations or results to differ materially from the operations and results anticipated in the forward-looking statements, including, but not limited to, the following: our history of significant losses, our need to mobilize additional capital and our ability to obtain additional capital on acceptable terms, if at all; our dependence on the success of our initial product candidate, PRF-110; results 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 in managing clinical trials; our ability to retain key personnel and recruit additional employees; our reliance on third parties for the conduct of clinical trials, manufacturing and product development; the impact of competition and new technologies; our ability to comply with regulatory requirements relating to the development and commercialization of our product candidates; the 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 business collaborations; the implementation of our business model and strategic plans for our businesses and product candidates; the extent 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 common stock and whether the market price of our common stock is volatile; and statements regarding 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 documents we have filed and may file. with the Securities and Exchange Commission in the future.
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