About Us | ScientistPRFX PainReform Ltd.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
PRF-110
Post-operative pain
|
Phase 3
Phase 3
|
Phase 3 trial planned for 3Q 2021.
|
Latest News
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HERZLIYA, Israel, May 13, 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 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.
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 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.Contact:
Crescendo Communications, LLC
Tel: 212-671-1021
Email: [email protected]Ilan Hadar
Chief Executive Officer
PainReform Ltd.
Tel: +972-54-5331725
Email: [email protected]
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HERZLIYA, Israel, March 18, 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 year-end business update.
Significant events and achievements during the fourth quarter 2020 and subsequent period:
- Preparation for the first Phase 3 clinical trial, for patients undergoing bunionectomy surgery, is expected to begin by mid-2021
- Announced the engagement of Lotus Clinical Research as the Company's clinical research organization to conduct the Phase 3 clinical trials under the leadership of Dr. Neil Singla
- Announced the appointment of Rita Keynan as Vice President of Pharmaceutical Operations
- Signed a manufacturing services and quality agreement with a subcontractor for GMP manufacturing of clinical trial batches of PRF-110
- Continued to build the patent estate, which now includes fourteen issued patents around the world, the earliest of which do not expire until 2033
- Announced a $6 million private placement, expected to provide funding into Q2 2022
Ilan Hadar, Chief Executive Officer of PainReform, commented, "We are making rapid progress towards commencing our Phase 3 clinical trials of PRF-110. Our first planned trial is for bunionectomy surgery. On the heels of the bunionectomy trial, we plan to commence our second Phase 3 trial for the treatment of hernia. In addition, we recently announced the appointment of Lotus Clinical Research as our clinical research organization to conduct the two clinical trials under the leadership of Dr. Neil Singla, one of the preeminent experts in analgesic protocol design. We also recently announced the appointment of Rita Keynan as Vice President of Pharmaceutical Operations, who brings over 25 years of experience in the pharmaceutical industry and will be an important addition to the team as we prepare to commence our Phase 3 pivotal trials for PRF-110. Most recently, we signed a manufacturing services and quality agreement with a subcontractor for manufacturing of regarding GMP manufacturing clinical trial batches of PRF-110."
Mr. Hadar concluded, "I am excited about the outlook for 2021 and look forward to a number of key upcoming catalysts that we believe will further enhance shareholders' value, including the start of enrolment and dosing of the first patients. Given that we were granted 505(b)(2) pathway by the FDA, I expect this to be a rapid and cost efficient trial. With the completion of our recent private placement, 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 completion of our first Phase 3 trial and reporting its top-line data."
Financial Results for the Year Ended December 31, 2020
Research and development expenses for the year ended December 31, 2020 were $354,000 an increase of $218,000, or 160% higher, compared to $136,000 for the prior year. The increase resulted primarily due to the preparations associated with the Company's planned Phase 3 trials.
General and administrative expenses for the year ended December 31, 2020 were $1.3 million, an increase of $764,000, or 138% compared to $553,000 for the prior year. The increase is primarily a result of the increase in professional services expenses, public company D&O insurance premiums and increase in payroll expenses related to the hiring, post IPO of additional management.
Operating loss for the year ended December 31, 2020 amounted to $1.7 million, compared to $689,000 for the year ended December 31, 2019.
Net financial expenses amounted to $2.2 million for the year ended December 31, 2020, compared to $590,000 for the year ended December 31, 2019. The increase is primarily due to the increase in interest expense, amortization of the discount on convertible notes and increase in expenses related to the change in the fair value of derivative warrant liability.
The Company's net loss for the year ended December 31, 2020 amounted was $4.1 million, compared to $1.3 million for the prior year.
The Company had $15.7 million in cash and cash equivalents as of December 31, 2020. In addition, on March 11, 2021, the Company closed a $6.0 million private placement, before placement agent fees and expenses. The Company believes that its cash and cash equivalents as of December 31, 2020, plus the net proceeds from the private placement will fund operating expenses and capital expenditure requirements into the second quarter of 2022.
Net cash used in operating activities for the year ended December 31, 2020 was $2.6 million, compared to $609,000 for the year before.
Net cash provided by financing activities for the year ended December 31, 2020 was $17.3 million, compared to $1.5 million for the prior year. The cash flows in 2020 primarily reflect net proceeds received from the Company's IPO on the Nasdaq Capital Market. The cash flows in 2019 primarily reflect the net proceeds from issuance of convertible notes.
More detailed information can be found in the Company's Annual Report on Form 20-F, a copy of which has been filed with the Securities and Exchange Commission and posted on the Company's website at www.painreform.com. You may request a copy of the Company's Form 20-F, at no cost to you, by writing to the Chief Financial Officer of the Company at 4 Bruria Street, Tel Aviv, Israel, 6745442 or by calling +972-3-717-7051.
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 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.
Contact:
Crescendo Communications, LLC
Tel: 212-671-1021
Email: [email protected]Ilan Hadar
Chief Executive Officer
PainReform Ltd.
Tel: +972-54-5331725
Email: [email protected]Statements of Comprehensive Loss:
(U.S. Dollars in thousands, except share and per share data)Year ended December 31, 2020 2019 Operating expenses: Research and development (354 ) (136 ) Selling, general and administrative (1,317 ) (553 ) Operating loss for the period (1,671 ) (689 ) Financial expenses, net: (2,162 ) (590 ) Loss before taxes (3,833 ) (1,279 ) Tax expenses (220 ) - Comprehensive loss (4,053 ) (1,279 ) Loss per ordinary share, basic and diluted (1.25 ) (4.17 ) Weighted average number of shares of ordinary share used in computing basic and diluted net loss per share 3,243,943 576,556 Balance sheet data
(U.S. Dollars in thousands)December 31, 2020 2019 Cash and cash equivalents 15,677 941 Restricted cash 13 6 Prepaid clinical trial expenses and deferred clinical trial costs 1,294 - Prepaid expenses and other current assets 807 25 Total current assets 17,791 972 Property and equipment, net 10 - Other non-current asset - 192 Total current liabilities 961 6,339 Convertible debt - - Provision for tax benefits 220 - Derivative warrant liability - 447 Temporary equity - 6,621 Shareholders' equity (deficit) 16,620 (12,243 ) -
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HERZLIYA, Israel, March 11, 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 announced that Ilan Hadar, CEO of PainReform, has been invited to present at the Inaugural Emerging Growth Virtual Conference, hosted by M Vest LLC and Maxim Group LLC. The presentation will be available to all registered participants of the conference on March 17th - 19th and will be posted on PainReform's website after March 19th.
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 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.
Contact:
Crescendo Communications, LLC
Tel: 212-671-1021
Email: [email protected]
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HERZLIYA, Israel, March 08, 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 announced that it has entered into securities purchase agreements with certain institutional investors to raise approximately $6.0 million through the private placement of 1,304,346 ordinary shares and accompanying warrants to purchase an aggregate of up to 652,173 ordinary shares at a combined purchase price of $4.60 per share and accompanying warrant. The warrants will be exercisable immediately at an exercise price of $4.60 per share and will expire five and a half years from the date of issuance. The closing of the private placement is expected to occur on March 10, 2021, subject to the satisfaction of certain customary closing conditions set forth in the securities purchase agreements.
Maxim Group LLC is acting as the lead placement agent and Joseph Gunnar & Co., LLC is acting as co-placement agent for the transaction.
The ordinary shares and warrants described above have not been registered under the Securities Act of 1933, as amended, and may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (SEC) or an applicable exemption from such registration requirements. The securities were offered only to accredited investors. Pursuant to a registration rights agreement with the investors, the Company has agreed to file one or more registration statements with the SEC covering the resale of the ordinary shares and the shares issuable upon exercise of the warrants.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
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 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: statements relating to the closing of the offering, which is subject to the satisfaction of customary closing conditions; the outcomes of preclinical studies, clinical trials and other research regarding PRF-110 and future product candidates, the commercialization and pricing of our product candidates, our competitors' development, marketing and sale of products that compete with our products our expectations regarding future growth, including our ability to develop an active trading market for our ordinary shares and whether the market price of our ordinary shares is volatile and our expectations regarding the maintenance of our foreign private issuer status and emerging growth company status. More detailed information about the risks and uncertainties affecting us is contained under the heading "Risk Factors" included in the Company's recent prospectus included in the registration statement, in the form last filed with the SEC and in other filings that we have made and may make with the Securities and Exchange Commission in the future.
Contact:
Crescendo Communications, LLC
Tel: 212-671-1021
Email: [email protected]Ilan Hadar
Chief Executive Officer
PainReform Ltd.
Tel: +972-54-5331725
Email: [email protected] -
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HERZLIYA, Israel, Jan. 07, 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 announced that it will be presenting at the H.C. Wainwright BioConnect 2021 Conference, being held virtually between January 11-14, 2021.
A webcast of PainReform's presentation will be available on-demand as of 6:00 a.m. ET, Monday, January 11, 2021 and will be accessible for 90 days. The webcast can be accessed here and the investor relations section of PainReform's website at www.painreform.com/investors-information/.
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 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.
Contact:
Crescendo Communications, LLC
Tel: 212-671-1021
Email: [email protected]