PainReform Provides Year-End Business Update
PainReform Ltd. (PRFX) provides a business update, reporting enrollment progress in Phase 3 clinical trial for PRF-110, a post-operative pain relief drug. The company aims to announce top-line data by mid-2024. Financially, research and development expenses increased, while general and administrative expenses decreased. The net loss for 2023 was $9.3 million, with cash and cash equivalents of $8.0 million.
Positive
PainReform continues enrollment in Phase 3 clinical trial for PRF-110.
Top-line data for PRF-110 expected by mid-2024.
Financially, research and development expenses increased to $6.0 million in 2023.
General and administrative expenses decreased to $3.6 million in 2023.
Net loss for 2023 was approximately $9.3 million.
Cash and cash equivalents stood at $8.0 million as of December 31, 2023.
The financial results disclosed by PainReform Ltd. indicate a strategic allocation of resources towards their clinical trials, specifically the Phase 3 trial of PRF-110. The increase in R&D expenses from $4.4 million to $6.0 million year-over-year reflects the company's commitment to advancing its lead drug candidate. This uptick is a common occurrence in biotech firms as they progress through clinical stages, but it warrants investor attention as it impacts the burn rate and the timeline for potential revenue generation.
On the other hand, the reduction in G&A expenses from $4.4 million to $3.6 million suggests effective cost management and possibly a strategic shift of focus from administrative to core research activities. The net loss widening from $8.8 million to $9.3 million is not unusual for a clinical-stage pharmaceutical company, yet it is crucial for stakeholders to monitor the company's cash runway. With $8.0 million in cash and equivalents, the financial position seems sufficient in the short-term but may necessitate additional funding, especially if the clinical trial extends beyond mid-2024 or encounters unforeseen hurdles.
The enrollment progress in PainReform's Phase 3 clinical trial is a critical step towards the potential approval and commercialization of PRF-110. The target enrollment of up to 400 patients is significant as it suggests a robust sample size, which can provide more statistically significant data. The positive in vitro test results mentioned, which highlight superior formulation properties, could differentiate PRF-110 from competitors and offer a unique selling proposition. However, the true test will be the clinical efficacy and safety data that will emerge from the ongoing trial.
The company's focus on reducing the need for opiates with PRF-110 taps into a pressing medical need, given the opioid crisis. If successful, PRF-110 could capture a considerable market share within the $12 billion post-operative pain treatment market. The drug's potential to become a standard-of-care will depend on its clinical outcomes compared to current treatments. Long-term, the impact on PainReform's business will be profound if PRF-110 is approved, but risks remain until regulatory approval is secured and commercialization strategies are proven effective.
The post-operative pain treatment market, valued at $12 billion, is a substantial opportunity for PainReform's PRF-110 if it proves to be a viable alternative to systemic opioids. Given the current climate of opioid aversion and the need for effective pain management solutions, a successful entry by PRF-110 could disrupt the market dynamics. The company's positive pharmacokinetic (PK) data from earlier trial phases is encouraging but must be contextualized within the broader competitive landscape, which includes a range of non-opioid pain management options.
Investors should consider the potential market penetration strategies and reimbursement scenarios for PRF-110, as these will significantly influence the commercial success of the product. Furthermore, the company's intellectual property position, regulatory pathway and partnership opportunities will be key factors in determining its ability to leverage the market opportunity presented by PRF-110.
03/01/2024 - 08:00 AM
Reports continued enrollment in the second part of the Phase 3 clinical trial in bunionectomy
Remains on track to announce top-line data by mid- 2024
TEL AVIV, Israel, March 01, 2024 (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 year ended December 31, 2023.
Ilan Hadar, Chief Executive Officer of PainReform, stated, “We are pleased to report significant progress this past year advancing PRF-110, our lead drug candidate for post-operative extended pain relief, thereby reducing the potential need for the use of opiates. Building on the success of the first part of our Phase 3 clinical trial of PRF-110, we are moving forward steadily with our enrollment. We have now enrolled over 140 patients in the trial, out of our target, of up to 400 patients at six clinical sites across the U.S. As a result, we remain on track to announce topline data around mid-2024. Moreover, we are pleased with the positive results of the recent in vitro tests, which further demonstrated the superior formulation properties of PRF-110 compared to the industry leader, with respect to surface-tissue spreading. Overall, we remain highly encouraged by the outlook for PRF-110 and our ongoing clinical trial given the positive PK data in the first part of our Phase 3 trial, as well as our prior Phase 2 data in hernia repair, confirming the safety and quality of our product as an alternative to systemic opioids. For these reasons, we remain confident PRF-110 has the potential to become standard-of-care within the $12 billion post-operative pain treatment market.”
Financial Results for the Ye ar E nded December 31, 2023
Research and development expenses were approximately $6.0 million for the year ended December 31, 2023, compared to approximately $4.4 million for the year ended December 31, 2022. The increase was primarily due to an increase in payments for clinical trial costs and manufacturing costs that were offset by a decrease in subcontractors and consultants’ expenses.
General and administrative expenses were approximately $3.6million for the year ended December 31, 2023, compared to approximately $4.4 million for the year ended December 31, 2022. The decrease was mainly in insurance costs and certain professional services costs.
Financial income, net, was approximately $248,000 for the year ended December 31, 2023, compared to financial income, net, of approximately $86,000 for the year ended December 31, 2022. The increase was primarily due to financial income resulting from a change in the valuation of warrants that were issued in 2023 and interest income from bank deposits, which was offset by losses from warrant issuance and issuance costs.
Net loss for the year ended December 31, 2023 was approximately $9.3 million , compared to a net loss of approximately $8.8 million for the year ended December 31, 2022.
As of December 31, 2023, the Company had cash and cash equivalents (including short term deposits) of approximately $8.0 million and a positive working capital of approximately $7.4 million .
A copy of the Company’s annual report on Form 20-F for the year ended December 31, 2023 has been filed with the U.S. Securities and Exchange Commission at https://www.sec.gov/ https://painreform.com/investors/ info@painreform.com
About PainReform
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 postoperative 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 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 repeated dose administration while reducing the potential need for the use of opiates. For more information, please visit www.painreform.com
Notice Regarding Forward-Looking Statements
This press release contains forward-looking statements about our expectations, beliefs and intention s including with respect to objectives , plans and strategies and expected timing of result s. 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 ability to continue as a going concern, 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; 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; 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 , including due to the current war between Israel and Hamas . 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.
Contact:
Crescendo Communications, LLCprfx@crescendo-ir.com
Ilan Hadarihadar@painreform.com
What is PainReform's ticker symbol?
PainReform's ticker symbol is PRFX.
What is the focus of PainReform's lead drug candidate PRF-110?
PRF-110 is focused on post-operative extended pain relief.
When is PainReform expected to announce top-line data for PRF-110?
PainReform aims to announce top-line data for PRF-110 by mid-2024.
How many patients have been enrolled in the Phase 3 clinical trial for PRF-110?
Over 140 patients have been enrolled in the Phase 3 clinical trial for PRF-110.
What were PainReform's research and development expenses for the year ended December 31, 2023?
Research and development expenses were approximately $6.0 million for the year ended December 31, 2023.
What was PainReform's net loss for the year ended December 31, 2023?
The net loss for the year ended December 31, 2023 was approximately $9.3 million.
