Duyuru • May 31
PRF Technologies Ltd. Advances DeepSolar Predict Toward Commercial Launch As AI Platform Targets Revenue Optimization Across Renewable Energy Markets PRF Technologies Ltd. provided an update on the advancement of DeepSolar Predict, the Company’s AI-driven renewable energy revenue optimization platform, as PRF continues to prepare the solution for planned commercial launch. DeepSolar Predict is designed to help renewable energy operators move from production monitoring and standalone forecasting to real-time revenue optimization by combining AI forecasting, storage intelligence and market-driven decision support in a single platform. DeepSolar Predict is being developed with the goal of helping renewable asset owners, operators, and energy market participants improve production forecasting, optimize energy commitments, reduce imbalance exposure, and support higher-value delivery decisions across solar, wind, and battery energy storage assets. The platform builds on PRF’s previously announced DeepSolar initiatives, including DeepSolar’s participation in the NVIDIA Connect Program and the Company’s patent application covering proprietary methods for plant-level micro-climate modeling designed to improve solar energy production forecast accuracy in competitive electricity markets. DeepSolar Predict is designed to address these challenges through a unified AI-driven platform that connects the full renewable asset workflow — from weather intelligence and production forecasting to commitment optimization, storage orchestration, delivery planning and real-time market decision support. The Company believes this integrated approach differentiates DeepSolar Predict from many existing market solutions that address only isolated parts of the renewable energy value chain. DeepSolar Predict is being developed to help operators convert complex operational and market data into actionable decisions intended to improve asset-level economics. Key planned capabilities of DeepSolar Predict include: Localized weather intelligence: plant- and asset-level weather modeling designed to improve short-term and intraday renewable production forecasts; Production forecasting: AI-driven forecasting intended to support more accurate day-ahead and intraday energy commitments; Imbalance risk management: tools designed to help operators reduce exposure caused by differences between committed and actual energy delivery; Storage optimization: decision support for battery energy storage systems, including when to store, dispatch or preserve capacity based on market conditions; Portfolio-level optimization: analytics intended to support renewable operators managing multiple assets across different geographies, grid conditions and market structures; Real-time market decision support: market-informed analytics designed to help operators identify higher-value delivery opportunities. PRF believes DeepSolar Predict is positioned to support a growing need among renewable asset owners, independent power producers, infrastructure investors and energy market participants seeking to improve forecasting accuracy, protect margins and maximize asset value as renewable portfolios scale globally. The Company’s DeepSolar platform has already advanced across multiple commercial and strategic initiatives, including solar analytics deployments, technical due diligence services, commercial collaboration agreements and development of proprietary forecasting technologies. PRF believes the planned launch of DeepSolar Predict would represent an important next step in expanding DeepSolar from solar asset analytics into broader AI-driven renewable energy optimization. New Risk • May 29
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 36% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$4.0m free cash flow). Share price has been highly volatile over the past 3 months (36% average weekly change). Earnings have declined by 11% per year over the past 5 years. Shareholders have been substantially diluted in the past year (116% increase in shares outstanding). Revenue is less than US$1m (US$17k revenue). Market cap is less than US$10m (US$1.19m market cap). Duyuru • May 26
PRF Technologies Reports Positive Preclinical Results for PRF-110 in Head-To-Head Study with ZYNRELEF PRF Technologies Ltd. announced positive results from a preclinical study in domestic pigs directly comparing its lead product candidate, PRF-110, to ZYNRELEF (bupivacaine and meloxicam extended-release solution), an approved extended-release product used as a benchmark in the study. PRF-110 is a proprietary, oil-based, viscous, clear extended-release formulation of ropivacaine designed to be deposited directly into the surgical wound bed prior to closure. The product candidate is being developed to provide prolonged local analgesia following surgery through a single administration at the surgical site. Such product is designed to reduce the use of opiates for post-surgical pain. In the head-to-head preclinical study, PRF-110 demonstrated sustained analgesic activity comparable to ZYNRELEF across the 72-hour post-surgical evaluation period. PRF-110 achieved this activity with a ropivacaine-only, NSAID-free formulation. Ropivacaine is a well-characterized long-acting local anesthetic that has demonstrated lower cardiac toxicity than bupivacaine in non-clinical pharmacology studies. The preclinical study was conducted in a validated pig incisional pain model, with von Frey methodology, used extensively to evaluate post-operative analgesic therapies. Animals were randomized to receive a single administration of either PRF-110 or ZYNRELEF into the surgical wound bed prior to closure. Pain-related endpoints were assessed at multiple timepoints over a 72-hour post-operative period. Analgesic activity was evaluated using standard measures of incisional pain in pigs, including behavioral and functional parameters, as well as stimulus-evoked responses. The active treatment arms were assessed for magnitude and duration of analgesic effect across early and late post-operative time windows. PRF-110 and ZYNRELEF each produced clear reductions in pain-related measures, confirming post-operative analgesic activity for both extended-release local analgesic formulations. Across the overall 72-hour assessment period, PRF-110’s analgesic effect was comparable to ZYNRELEF on the primary efficacy endpoints evaluated in this head-to-head preclinical setting. At later post-operative timepoints, PRF-110 maintained analgesic efficacy comparable to ZYNRELEF, supporting the sustained-release characteristics of PRF-110 following a single administration. PRF-110’s safety and local tolerability profile in pigs was consistent with prior preclinical experience, with no unexpected findings observed at the doses tested. PRF believes the findings provide useful supportive data as the Company evaluates the next steps for PRF-110’s development and regulatory strategy. The Company believes the head-to-head comparison with an approved benchmark may help inform future development planning for PRF-110, including study design, formulation positioning and potential regulatory engagement. PRF-110 is a proprietary, oil-based, viscous, clear extended-release solution based on the local anesthetic ropivacaine and is being developed for the post-operative pain relief market. PRF-110 is designed to be deposited directly into the surgical wound bed prior to closure to provide localized and extended post-operative analgesia. The formulation is designed to remain in place at the surgical site, spread over and adhere to the wound surface, resist rapid clearance, and provide sustained local release of ropivacaine. PRF-110 is being developed to provide prolonged post-operative pain relief following a single administration, with the goal of reducing the need for repeated dosing and potentially reducing reliance on opioids after surgery. Duyuru • Apr 30
PRF Technologies Ltd. Announces FDA Clearance Of IND Application For OcuRing-K Phase II Clinical Trial PRF Technologies Ltd. announced that the U.S. Food and Drug Administration has cleared the Company’s Investigational New Drug application for OcuRing-K, enabling the initiation of a Phase II clinical trial in patients undergoing cataract surgery. The IND clearance marks an important regulatory milestone for PRF and advances the Company’s strategy to develop OcuRing-K as a drop-less, sustained-release therapy designed to address pain and inflammation following cataract surgery. OcuRing-K is a patent-protected, bio-erodible intraocular ring designed to deliver ketorolac through a single intraoperative application. The platform is intended to provide sustained, localized drug release at the surgical site, potentially eliminating the need for complex post-surgical eye-drop regimens that can burden patients and contribute to inconsistent compliance. Following IND clearance and completion of trial-startup activities, PRF plans to initiate a multi-center Phase II clinical trial in the United States, with patient enrollment expected to begin in the second half of 2026. The study is expected to evaluate endpoints related to pain reduction, inflammation control, and overall safety. Cataract surgery is one of the most commonly performed surgical procedures worldwide, yet post-operative recovery often still depends on weeks of topical steroid and NSAID eye drops. PRF believes OcuRing-K’s sustained-release, intraoperative approach may offer a differentiated alternative by improving drug-delivery consistency, reducing dosing burden, and supporting better patient adherence. PRF has previously highlighted that the broader LayerBio ocular platform may also support additional ophthalmic applications over time, including other NSAID, steroid, antibiotic, and anti-VEGF opportunities. Through its majority ownership of LayerBio Inc., PRF believes it is building a differentiated ophthalmic platform with the potential to expand across multiple product candidates and indications, while creating an additional long-term value driver within its broader healthcare portfolio. Board Change • Mar 12
Less than half of directors are independent Following the recent departure of a director, there are only 2 independent directors on the board. The company's board is composed of: 2 independent directors. 3 non-independent directors. Independent External Director Gus Lawlor was the last independent director to join the board, commencing their role in 2020. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Duyuru • Jan 21
PRF Technologies Ltd. Files Its First Patent Application for Solar Plant Micro-Climate Forecast Modeling Designed to Improve Energy Production Forecast Accuracy PRF Technologies Ltd. announced that it has filed a patent application covering proprietary methods for solar plant-level micro-climate modeling designed to significantly improve the accuracy of solar energy production forecasts in competitive electric utility markets. The patent follows acceptance into the NVIDIA Connect Program and aims to protect core intellectual property underlying DeepSolar Predict, PRF Technologies' solar forecasting software platform. The technology is designed to address a critical limitation in conventional solar forecasting: the reliance on regional or broad-area weather models that fail to capture the highly localized conditions that directly impact power output at individual solar plants. By modeling micro-climate behavior unique to each solar installation, the patented approach aims to enable more precise short-term and intraday production forecasts that reflect real operating conditions rather than broad regional averages. The system continuously adapts to localized environmental dynamics, allowing forecasts to evolve in real time as conditions change. Improved forecast accuracy has direct commercial implications for solar asset owners, operators, and energy market participants. More reliable production estimates can potentially support stronger positioning in day-ahead and intraday electricity markets, reduce financial penalties from forecast errors, enhance revenue capture during favorable pricing conditions, and improve operational decision-making across plant control and energy management systems. PRF Technologies believes that, upon commercialization, DeepSolar Predict can help utility-scale solar operators and energy traders optimize dispatch decisions, improve risk management, and enhance the overall financial performance of solar plants, particularly in markets where pricing volatility and imbalance penalties materially affect returns. The patent filing further strengthens PRF Technologies' growing portfolio of energy-focused intellectual property and supports the Company's strategy to expand its presence in the rapidly growing global market for data-driven renewable energy optimization solutions. New Risk • Jan 20
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$6.0m free cash flow). Share price has been highly volatile over the past 3 months (16% average weekly change). Earnings have declined by 22% per year over the past 5 years. Shareholders have been substantially diluted in the past year (348% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$4.42m market cap). Duyuru • Jan 13
PainReform Ltd. and LayerBio, Inc. Announces Safety Data Supporting the Continued Development of OcuRing-K Drop-less, Sustainable-Release Ocular Drug Delivery Platform for Use in Cataract Surgery PainReform Ltd. together with its majority-owned subsidiary LayerBio Inc. announced safety data supporting the continued development of OcuRing™?-K drop-less, sustained-release ocular drug delivery platform for use in cataract surgery. The development program included a series of preclinical rabbit studies evaluating ocular tolerability, biocompatibility, and tissue response, as well as a Phase I clinical study in patients undergoing cataract surgery. Collectively, these studies demonstrated a favorable safety profile for the platform, supporting its advancement toward later-stage development. In the Phase I clinical study, no treatment-emergent adverse events related to the study drug were observed. All reported adverse events were as expected in the context of cataract surgery, and consistent with subjects' underlying ocular histories. No serious adverse events were reported, and no safety issues related to the drug delivery platform were identified. OcuRing™?- K's intraocular drug delivery system is designed to provide targeted, sustained release of non-steroidal anti-inflammatory drugs (NSAIDs), corticosteroids, or other ophthalmic therapeutics through a single intraoperative application. The platform utilizes a preservative-free formulation and controlled-release mechanism intended to minimize local irritation, reduce epithelial toxicity, and limit systemic exposure associated with traditional topical dosing regimens. Building on previously disclosed progress toward an Investigational New Drug (IND) submission, PainReform and LayerBio are advancing IND-enabling activities, with preparation and development efforts well underway to support the next phase of clinical evaluation in the United States. Duyuru • Jan 06
PainReform Ltd.'s Deepsolar Launches Smart TDD, A Next-Generation Solar Due Diligence Service Targeting the $60B+ Global Solar Asset M&A Market PainReform Ltd. announced that its DeepSolar business unit has launched Smart TDD, an advanced solar Technical Due Diligence ("TDD") service designed to provide faster, more accurate, and more comprehensive assessments of solar asset performance and risk. The newly enhanced service expands DeepSolar's audit capabilities to support independent power producers (IPPs), infrastructure funds, operators, lenders, and insurers at every major lifecycle milestone of a solar asset. Solar continues to experience historic global growth, with more than $500 billion invested in 2024 and over $60 billion in solar assets changing hands annually. At the same time, tens of gigawatts of capacity are reaching warranty expiration or showing mid-life underperformance--driving urgent demand for reliable, data-driven technical assessments. Yet most traditional TDD processes still rely on partial sampling, manual inspections, and over-simplified models that often miss underlying problems, extend deal cycles, and increase financial risk. The launch of Smart TDD reinforces DeepSolar's role as a trusted analytics partner for the global solar sector. As aging assets face increasing performance issues and M&A activity continues to accelerate, the demand for high-quality technical due diligence services is expected to rise sharply, and DeepSolar's enhanced platform is designed to deliver at scale. Duyuru • Dec 11
Painreform Ltd. Announces Its Pharmaceutical Division Has Completed an R&D Assessment of Layerbio's Proprietary Drop-Less, Sustained-Release Ocular Drug-Delivery Platform painReform Ltd. announced that its pharmaceutical division has completed an R&D assessment of LayerBio's proprietary drop-less, sustained-release ocular drug-delivery platform. The assessment confirmed that its sustained release, polymer matrix platform can incorporate a variety of drug entities, reinforcing its long-term potential to provide greatly improved pharmacological efficiency and simplify postoperative care for cataract patients by reducing or eliminating the need for medicated eye drops - the DROP-LESS advantage. The matrix platform successfully incorporated corticosteroids and NSAIDs--two major therapeutic drug classes routinely used after cataract surgery. The results support the technical feasibility of multi-drug potential. LayerBio's pre-fabricated OcuRing is placed during cataract surgery via an intraocular route, enabling sustained-release drug delivery to targeted ocular tissues. By providing controlled exposure at a fraction of the total drug amount used in traditional eye-drop regimens, the platform has the potential to improve patient comfort, reduce safety risks associated with higher drop dosing and significantly enhance compliance--an important unmet need especially among elderly cataract patients. Duyuru • Dec 03
PainReform Ltd. Commences Development for OcuRing™?-K Phase II Trial, LayerBio's Drop-Less Sustained-Release Ocular Therapy painReform Ltd. announced, through its pharmaceutical division, the commencement of its development plan for OcuRing™?-K, LayerBio's patented, drop-less, intraoperatively administered sustained-release ocular therapy designed to deliver controlled, site-specific release of ketorolac following cataract surgery. Following the closing of PainReform's majority investment in LayerBio and the integration of OcuRing-K into PainReform's development portfolio, the Company conducted a methodical internal assessment with LayerBio's management team to define development priorities and establish a clear path for advancing the program. Work is now progressing toward the Phase II clinical trial. OcuRing-K is an erodible, intraoperatively administered sustained the device designed to provide extended and consistent intraocular therapeutic levels of an NSAID (non-steroidal, non-opiate, anti-inflammatory angesic). By removing the need for patient-administered drops, OcuRing-K also reduces contamination risks, such as inadvertent contact between dropper bottles and ocular tissues. Preclinical studies and a Phase I clinical evaluation demonstrated reductions in post-surgical pain and inflammation while using significantly lower total drug exposure than standard eye-drop regimens. The sustained-release kinetics of OcuRing-K maintained therapeutic levels over time, supporting the potential for improved ocular safety, reduced systemic side effects associated with high-volume topical dosing, and enhanced patient compliance, particularly among elderly populations. LayerBio's sustained-release platform also supports delivery of a wide range of other ocular therapeutics--including NSAIDs, antibiotics, steroids, and anti-VEGF agents--aligning with PainReform's plans to explore additional ophthalmic indications following the development of OcuRing-K. Duyuru • Nov 26
PainReform Ltd., Annual General Meeting, Dec 30, 2025 PainReform Ltd., Annual General Meeting, Dec 30, 2025. Location: amit, pollak, matalon & co., at apm house, 18 raoul wallenberg st., building d, 6th floor, ramat hachayal, tel aviv-yafo Israel Duyuru • Nov 13
PainReform's DeepSolar Advances Development of its AI-Driven Automated Reporting Engine for Solar-Asset Analysis painReform Ltd. announced that DeepSolar, its solar energy business unit developing next-generation AI analytics, has advanced the development of its proprietary automated reporting engine, designed to transform how solar-asset performance is analyzed, understood, and communicated. The automated reporting engine reduces manual effort and produces tailored reports according to the customers' needs. Performance reports are essential tools for executive management, investors, and asset owners to assess a plant's operational and financial performance, identify the root causes of output variations, and evaluate return on investment (ROI). Currently, producing such reports requires manual aggregation of data from multiple systems--including SCADA, monitoring platforms, weather feeds, and market data--followed by labor-intensive analysis and formatting. DeepSolar's new AI-powered reporting engine is being designed to automate and streamline this process. Once completed, it will automatically consolidate and interpret data from diverse sources, delivering customized, insight-rich reports within minutes. The platform will allow users to define the depth of analysis, visualization style, and reporting frequency to meet operational, managerial, and investor needs--all seamlessly integrated within DeepSolar's advanced AI analytics framework. New Risk • Aug 19
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 24% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$13m free cash flow). Share price has been highly volatile over the past 3 months (24% average weekly change). Earnings have declined by 32% per year over the past 5 years. Shareholders have been substantially diluted in the past year (over 12x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$2.70m market cap). New Risk • Apr 16
New major risk - Revenue and earnings growth Earnings have declined by 32% per year over the past 5 years. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are declining over an extended period, then in most cases the share price will decline over time unless the company can turn around its fortunes. A trend of falling earnings can be very difficult to turn around. If the company is well already established it may also be a sign the company has matured and is in decline. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$13m free cash flow). Earnings have declined by 32% per year over the past 5 years. Shareholders have been substantially diluted in the past year (over 22x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$3.46m market cap). Minor Risk Share price has been volatile over the past 3 months (15% average weekly change). Duyuru • Mar 07
PainReform Ltd. (NasdaqCM:PRFX) completed the acquisition of Business Activities Associated with the DeepSolar Technology of BladeRanger Ltd. PainReform Ltd. (NasdaqCM:PRFX) entered into a business acquisition agreement to acquire Business Activities Associated with the DeepSolar Technology of BladeRanger Ltd for ILS 1.8 million on February 17, 2025. In consideration for the sale of the Acquired Assets, BladeRanger is entitled to receive (1) 178,769 ordinary shares of the Company, representing 9.9% of the issued and outstanding share capital of the Company (after such issuance); (2) 223,792 pre-funded warrants to purchase 223,792 ordinary shares; (3) 685,004 pre-funded milestone warrants to purchase 685,004 ordinary shares; (4) 1,087,565 warrants-A to purchase 1,087,565 ordinary shares ; and (5) 1,087,565 warrants-B to purchase 1,087,565 ordinary shares (collectively, the “Securities”).
The business acquisition is conditioned upon customary closing conditions. and is expected to be consummated by the end of February 2025, subject to the satisfaction of customary closing conditions.
PainReform Ltd. (NasdaqCM:PRFX) completed the acquisition of Business Activities Associated with the DeepSolar Technology of BladeRanger Ltd on March 5, 2025. New Risk • Mar 03
New minor risk - Financial data availability The company's latest financial reports are more than 6 months old. Last reported fiscal period ended June 2024. This is considered a minor risk. If the company has not reported its earnings on time, it may have been delayed due to audit problems or it may be finding it difficult to reconcile its accounts. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (56% average daily change). Negative equity (-US$2.0m). Shareholders have been substantially diluted in the past year (over 11x increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$2.76m market cap). Minor Risks Latest financial reports are more than 6 months old (reported June 2024 fiscal period end). Currently unprofitable and not forecast to become profitable over next 3 years (US$25m net loss in 3 years). Duyuru • Feb 19
PainReform Ltd. (NasdaqCM:PRFX) entered into a business acquisition agreement to acquire Business Activities Associated with the DeepSolar Technology of BladeRanger Ltd for ILS 1.8 million. PainReform Ltd. (NasdaqCM:PRFX) entered into a business acquisition agreement to acquire Business Activities Associated with the DeepSolar Technology of BladeRanger Ltd for ILS 1.8 million on February 17, 2025. In consideration for the sale of the Acquired Assets, BladeRanger is entitled to receive (1) 178,769 ordinary shares of the Company, representing 9.9% of the issued and outstanding share capital of the Company (after such issuance); (2) 223,792 pre-funded warrants to purchase 223,792 ordinary shares; (3) 685,004 pre-funded milestone warrants to purchase 685,004 ordinary shares; (4) 1,087,565 warrants-A to purchase 1,087,565 ordinary shares ; and (5) 1,087,565 warrants-B to purchase 1,087,565 ordinary shares (collectively, the “Securities”).
The business acquisition is conditioned upon customary closing conditions. and is expected to be consummated by the end of February 2025, subject to the satisfaction of customary closing conditions. Duyuru • Dec 27
PainReform Ltd. Provides Further Update on Phase 3 Clinical Trial of PRF-110 PainReform Ltd. announced an update regarding its Phase 3 clinical trial evaluating PRF-110 in post-surgical pain management of patients undergoing bunionectomy.PainReform previously disclosed initial topline data from its Phase 3 clinical trial in which it reported that it demonstrated statistically significant superiority over placebo in reducing pain during the first 48 hours following surgery. Yet, at that time, data pertaining to the last 24-hour period of the 72-hour study follow-up was unclear, and efforts were made to resolve the incoherence and complete the analysis.Following further investigation, PainReform has determined that the data from the final 24-hour period could not be clarified to satisfy the study’s primary endpoint 72 hours requirement, and therefore, it did not meet the primary endpoint of the study. Despite this setback, the Company has initiated research and development (R&D) activities to better understand and refine the pharmaco-kinetics and pharmaco-dynamics of PRF-110 based on the data received from the study. These efforts are intended to potentially resolve this issue to support future clinical trials. Duyuru • Dec 06
Painreform Ltd. Announces CFO Changes PainReform Ltd. appointed Mr. Eyal Broder as the Company’s Interim Chief Financial Officer until a replacement is appointed, replacing Dr. Ehud Geller, the current Executive Chairman of the Board, Interim Chief Executive Officer and Chief Financial Officer. Dr. Geller will continue to serve as the Executive Chairman of the Board and Interim Chief Executive Officer of the Company. Prior to his appointment as their Interim Chief Financial Officer, Mr. Broder served as their Finance Director since February 2023. Previously, Mr. Broder served as Chief Financial Officer at several leading companies, including Inomize, Tradenet Group, Elbit Imaging India and Koor Industries. Mr. Broder holds a BA in Accounting and Economics and an MBA in Business Management, both from Tel Aviv University. Duyuru • Nov 20
PainReform Ltd. Announces Initial Topline Data for PRF-110 Phase 3 Clinical Trial PainReform Ltd. announced the receipt of partial topline data from its contract research organization (CRO), Lotus Clinical Research ("Lotus"), for the Phase 3 clinical trial evaluating PRF-110 in post-surgical pain management of patients undergoing bunionectomy. Initial analysis of the topline data indicates that PRF-110 demonstrated statistically significant superiority over placebo in reducing pain during the first 48 hours following surgery. These findings underscore PRF-110's potential to provide effective pain relief during the critical early postoperative period. However, data pertaining to the subsequent 24-hour period, which is essential for assessing the primary endpoint of the trial, is currently unclear due to incoherence of the data. PainReform is actively collaborating with Lotus to resolve this to complete the analysis of this portion of the data. At present, there can be no assurance that the effort to resolve the incoherence will be successful. PRF-110 is PainReform's proprietary, oil-based, extended-release formulation of ropivacaine, a widely used local anesthetic. Designed to provide prolonged pain relief while reducing the need for opioids, PRF-110 has the potential to significantly enhance patient recovery and safety in the post-surgical setting. The bunionectomy Phase 3 trial is a randomized, double-blind, placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of intra-operative administration of PRF-110 following unilateral bunionectomy. The study is conducted in two parts. In the first part, a total of 15 patients were enrolled in an open label study at a single site in which PRF-110 was administered intra-operatively to measure safety and plasma concentration levels. All safety requirements including plasma concentration levels were met, and the study proceeded to the second part. In the second part, the company randomized 428 patients. PRF-110 was administered intra-operatively and patients were divided into three cohorts, PRF-110, Naropin® (ropivacaine), and placebo in a 2:2:1 ratio. The primary efficacy endpoint is mean area under the curve, or AUC, of the numerical rating scale, or NRS, of pain intensity scores over 72 hours (AUC0-72) for PRF110 compared with placebo. Secondary efficacy endpoints include mean AUC0-72 of the NRS of pain intensity scores for PRF110 compared with plain ropivacaine, total post-surgery opioid consumption (in morphine equivalents) over 72 hours for PRF110 compared with saline placebo, the proportion of subjects who are opioid-free through 72 hours for PRF110 compared to that of plain ropivacaine, the total postoperative opioid consumption through 72 hours for PRF110 compared to that of plain ropivacaine. Safety endpoints include incidence of treatment emergent adverse events and serious adverse events, physical examination, vital signs and wound healing. If the first Phase 3 clinical trial of patients undergoing bunionectomy is successful, the company plan to initiate a second trial for pain treatment of hernia repair operations. Duyuru • Nov 08
PainReform Announces Receipt of Nasdaq Notice Regarding Minimum Stockholders’ Equity Requirement PainReform Ltd. announced that it has received a notification from the Listing Qualifications Department of the Nasdaq Stock Market LLC (“Nasdaq”) advising the Company that it no longer satisfied the minimum $2.5 million stockholders’ equity requirement for continued listing on Nasdaq set in Nasdaq Listing Rule 5550(b)(1) (the “Minimum Equity Rule”) or, alternatively, the requirement that the Company either maintain a market value of listed securities of at least $35 million or generate net income from continuing operations of $500,000 in the most recently completed fiscal year or two of the last three most recently completed fiscal years. The notification from Nasdaq has no immediate effect on PainReform’s business or the listing or trading of PainReform’s ordinary shares which continue to trade on the Nasdaq Capital Market under the symbol “PRFX.” PainReform has 45 days from the date of the notice, or until December 19, 2024, to submit to Nasdaq a plan to regain compliance with the Minimum Equity Rule or an alternative continued listing standard. If the plan is accepted, Nasdaq may grant an extension of up to 180 calendar days from the date of the notice, or until May 3, 2025, for the Company to regain compliance. Duyuru • Oct 17
PainReform Ltd. has filed a Follow-on Equity Offering in the amount of $1.35 million. PainReform Ltd. has filed a Follow-on Equity Offering in the amount of $1.35 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Transaction Features: At the Market Offering Duyuru • Aug 29
PainReform Ltd., Annual General Meeting, Sep 30, 2024 PainReform Ltd., Annual General Meeting, Sep 30, 2024. Location: the offices of the companys attorneys, doron tikotzky kantor gutman & amit gross, 7 metsada st., b.s.r tower 4,33 floor, bnei brak Israel Duyuru • Aug 22
PainReform Ltd. Announces Successful Determination of Optimal Delivery Method for PRF-110 in Bunionectomy Procedures PainReform Ltd. announced the successful determination of the optimal delivery method for PRF-110 in bunionectomy procedures. This achievement marks a significant milestone aimed at advancing PRF-110 as a leading post-surgical pain management solution. Building on previously reported in-vitro studies that demonstrated the superior spreadability of PRF-110, PainReform has now completed comprehensive Phase III evaluations, focusing on the practical application of the product in surgical wounds. The findings underscore PRF-110's exceptional physical properties, which ensure optimal coverage of cut nerve endings and traumatized tissue surfaces, contributing to effective post-surgical pain control. Key Findings from the Phase III Study: Effective Wound Coverage: PRF-110 was observed to provide thorough coverage of both nerve endings and surrounding tissue surfaces. This is crucial for maximizing pain relief, as full coverage ensures that the product remains in place throughout wound closure and delivers the intended dose directly to the target area. Competitive Advantages: Unlike a leading competitor’s aqueous liposomal suspension, which requires multiple injections with difficulty in achieving full instillation (coverage of the whole wound bed), PRF-110 demonstrated superior adhesion and location adherence over the wound bed. Additionally, PRF-110 resolved another competitor's product issue, being too viscous and becoming increasingly difficult to manage when interacting with physiological fluids. Enhanced Viscosity and Uniformity: PRF-110 exhibited optimal viscosity and uniformity, maintaining its effectiveness even in the presence of physiological fluids. These attributes facilitated ease of application and ensured that the product could be evenly distributed across the wound bed. Precision Delivery Coverage: To ensure comprehensive coverage within the wound geometry, PRF-110 was administered using a cannula connected to the syringe’s Luer lock. This method enabled precise delivery to all parts of the wound, further enhancing the product's therapeutic impact. Duyuru • Aug 20
painReform Ltd. Announces Positive Safety Profile for PRF-110 in Phase 3 Bunionectomy Study painReform Ltd. announced encouraging early safety results from its ongoing Phase 3 bunionectomy study of PRF-110, the Company's proprietary post-surgical pain formulation. The study, which has now completed full enrollment with a total of 443 patients across eight clinical sites in the United States, is designed as a randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of PRF-110 in patients undergoing bunionectomy, a common outpatient surgical procedure. Initial safety data from the study revealed a low incidence of adverse events, averaging just one per subject. PRF-110’s safety and efficacy are further supported by extensive clinical and preclinical testing, positioning it as a potential leader in the market. The company remains committed to advancing PRF-110 through the final stages of clinical development, with the aim of providing patients and healthcare providers with a novel, non-opioid solution for post-surgical pain management. New Risk • Aug 18
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$11m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$11m free cash flow). Negative equity (-US$2.0m). Shareholders have been substantially diluted in the past year (181% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$1.17m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$25m net loss in 3 years). Share price has been volatile over the past 3 months (15% average weekly change). Duyuru • Aug 13
PainReform Ltd. Announces Development and Successful Manufacturing of New Formulations Providing Anti-Inflammatory and Extended Analgesic Effects PainReform Ltd. announced the successful development and manufacturing of new patented formulations of its extended postoperative pain relief therapy, PRF-110. These novel formulations may incorporate both the angesic and an anti-inflammatory agent, designed to enhance postoperative recovery. Nerve blockades are critical for managing pain over extended periods, preventing complications, and accelerating recovery post-surgery. Adding an anti-inflammatory agent, such as a steroid, to a local anesthetic like ropivacaine has been demonstrated to extend and enhance the anesthetic effect. This combination not only provides a quicker onset of pain relief but also reduces the reliance on opioids post-operatively. Ropivacaine is preferred over bupivacaine for surgical blocks due to its lower neurotoxicity and cardiotoxicity, as well as a reduced risk of bone chondrotoxicity. By combining ropivacaine with dexamethasone, a potent anti-inflammatory agent, PainReform aims to deliver superior pain management. This combination is already employed in various peripheral nerve blocks, including transversus abdominis plane blocks, interscalene blocks, and adductor canal blocks. PainReform's PRF-110 formulation uniquely supports the administration of ropivacaine-steroid mixtures while ensuring product stability—a challenging feat with such combinations. The company holds a patent for the ropivacaine and dexamethasone mixture and has successfully manufactured specific combination products of PRF-110, containing 3.6% or 3.0% ropivacaine and 0.1-0.5% dexamethasone. These formulations have demonstrated promising stability in ongoing studies. Duyuru • Aug 08
PainReform Ltd. Announces Favorable Safety Profile of PRF-110, Indicating Potential for Use in New Surgical Applications Requiring Higher Doses PainReform Ltd. announced compelling safety data for its lead product candidate, PRF-110. This data, derived from pharmacokinetic (PK) studies in both herniorrhaphy and bunionectomy clinical trials, highlights PRF-110's promising safety profile, with maximum blood levels (Cmax) recorded at approximately 10% of the FDA-established safety threshold. Local anesthetics, such as ropivacaine—the active pharmaceutical ingredient (API) in PRF-110—and bupivacaine, the API in other products like Exparel and Zynrelef, are known for their correlation between Cmax levels and the risk of cardiovascular toxicity and central nervous system (CNS) adverse events. The threshold for these adverse events is typically between 2000-4000 ng/ml (Clinical Drug Investigation, 2013, 33 pp. 109-115). The results from the PRF-110 studies suggest that the product remains well within safe limits, underscoring its potential for broader surgical applications. PRF-110 is a viscous, oil-based, clear solution designed for direct application into the surgical wound bed before closure, providing localized and extended postoperative analgesia. The formulation ensures controlled release of the API over time, avoiding dose dumping. The use of ropivacaine in PRF-110, regarded as the safest long-acting local anesthetic (Local and Regional Anesthesia, 2010; 3: 11–19), is a significant advantage, offering the potential for higher doses and larger product volumes in various surgical operations compared to other anesthetics. Duyuru • Aug 06
PainReform Ltd. Announces Favorable Wound Healing Data in Human Clinical Trials for PRF-110 PainReform Ltd. announced positive wound healing data from its human clinical trials investigating the efficacy of PRF-110, the Company’s lead asset designed to provide extended, non-opiate, post-surgical pain relief. Building on extensive preclinical research, PainReform previously conducted wound healing studies in animal models which demonstrated that PRF-110 allows for normal wound healing of surgical incisions comparable to both Naropin (ropivacaine) and saline. Importantly, these studies showed no adverse histological or radiologic effects on soft or bony tissues. The recent human clinical trials included patients undergoing both hard tissue (bunionectomy) and soft tissue (hernia) surgeries. Results from these trials indicated no abnormalities in wound healing or scar formation among patients treated with PRF-110. Wound healing in all patients was complete and consistent with outcomes expected from surgeries without PRF-110. PRF-110's formulation includes approximately 55% lecithin, which forms liposome-like structures upon contact with body fluids. This feature is particularly noteworthy as existing literature suggests that lecithin liposomes enhance wound healing through in vitro antioxidant activity and in vivo wound-healing models. The potential beneficial effects of PRF-110 on the wound healing process are further supported by these in vitro, in vivo, and human studies. PainReform continues to advance the development of PRF-110 and is on track to report top-line results from the Phase 3 trial in the second half of 2024. These results are expected to further inform the regulatory submission process and potential commercialization plans. Duyuru • Aug 02
PainReform Ltd. Announces New Manufacturing Process Achieves Significant Benefits Including 18-Month Stability of PRF-110 at Room Temperature PainReform Ltd. announced a major advancement in the development of its lead asset, PRF-110. The Company's new highly scalable manufacturing process, for which it recently filed a new patent, has enabled PRF-110 to achieve full product stability for 18 months at room temperature. This stability study is ongoing and marks a significant achievement for PainReform. Drug stability, or shelf life, is defined as the ability of a drug substance or product to maintain its original properties and characteristics within specified limits during storage. This is crucial for ensuring the drug's safety and efficacy. The demonstrated stability of PRF-110 at room temperature is a critical milestone for PainReform as it significantly eases handling and transportation and reduces associated costs, all of which are vital for ensuring future market penetration and wide-scale use. The company continues to advance the development of PRF-110 and is on track to report top-line results from the Phase 3 trial in the second half of 2024. These results are expected to further inform the regulatory submission process and potential commercialization plans. Duyuru • Jul 25
PainReform Ltd. Files Patent Covering Highly Scalable Manufacturing Process for PRF-110 Following Successful Completion and Testing PainReform Ltd. announced it has filed a patent covering its new and highly scalable manufacturing process for PRF-110, its product designed to revolutionize post-operative pain control. The patent filing follows successful completion and testing of the new process. This milestone not only marks a critical step forward in preparation for future potential market launch of PRF-110, allowing a smooth step-wise increase of batch manufacturing, but also underscores the Company's commitment to enhancing manufacturing efficiency and reducing costs. The key improvements introduced in the manufacturing process include: Continuous Process Manufacturing: Streamlining production to ensure constant and efficient output, thereby significantly reducing downtime and increasing overall productivity. Single Reactor Manufacturing: Simplifying the manufacturing process by using a single reactor, which not only reduces equipment and maintenance costs but also minimizes the risk of exposure to contamination. Enhanced Batch Size: Incorporating additional steps that facilitate larger batch sizes while maintaining the stringent product quality attributes. These innovative manufacturing techniques are now being protected by a patent application filed by PainReform, highlighting the Company's dedication to intellectual property support. The introduction of these manufacturing improvements is expected to have a positive impact on the production cost of PRF-110, leading to a reduction in the cost of goods sold (COGS). Duyuru • Jun 26
PainReform Ltd. Completes Enrollment in the Second Part of Its Phase 3 Bunionectomy Trial for Prf-110 PainReform Ltd. announced a major milestone on the way to registration - the successful completion of patient enrollment in its Phase 3 clinical trial for PRF-110, a novel analgesic drug candidate designed for the treatment of post-operative pain. In total, 428 patients have been enrolled at eight clinical sites across the U.S. As the study pain score is being tracked for 72 hours, the end of enrollment is generally the end of the clinical part of the study. The Phase 3 trial, a randomized, double-blind, placebo-controlled study, is designed to evaluate the efficacy and safety of PRF-110 in patients undergoing bunionectomy, a common outpatient surgical procedure. Completion of enrollment in this trial marks a significant milestone in the development of PRF-110 and brings the Company closer to potentially offering a new, non-opioid pain management solution to patients and healthcare providers. This innovative drug candidate leverages a patented, oil-based, extended-release formulation of the well-established local anesthetic, ropivacaine, to provide effective and prolonged pain relief. The Company anticipates reporting top-line results from the Phase 3 trial in the second half of 2024, which will further inform the regulatory submission process and potential commercialization plans. The trial's primary endpoint is to demonstrate a significant reduction in post-operative pain intensity compared to placebo over the first 72 hours after surgery. Secondary endpoints include reduction in post-operative pain intensity compared to Naropin (ropivacaine), evaluating the total consumption of rescue analgesics and the overall safety and tolerability of PRF-110. New Risk • Jun 14
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of American stocks, typically moving 16% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (16% average weekly change). Shareholders have been substantially diluted in the past year (131% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$1.36m market cap). Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$26m net loss in 3 years). Duyuru • Apr 19
PainReform Ltd. has completed a Follow-on Equity Offering in the amount of $7.999045 million. PainReform Ltd. has completed a Follow-on Equity Offering in the amount of $7.999045 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Securities Offered: 447,500
Price\Range: $0.8
Discount Per Security: $0.056
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant
Securities Offered: 4,552,500
Price\Range: $0.7999
Discount Per Security: $0.056
Security Name: Common Warrants
Security Type: Equity Warrant
Securities Offered: 5,000,000
Price\Range: $0.7999
Discount Per Security: $0.056 Duyuru • Apr 12
Painreform Ltd. Announces Groundbreaking Results from New Studies Demonstrating the Superior In-Vitro Release Rates of PRF-110 PainReform Ltd. announced groundbreaking results from new studies demonstrating the superior in-vitro release (IVR) rates of PRF-110 compared to the industry leader for topical post-surgical pain management products. These findings underscore PainReform's commitment to advancing non-opiate pain relief options and mark a significant milestone in the development of long-lasting pain management solutions. Leveraging the latest IVR technology, which automates the testing of drug release from formulations over time, PainReform conducted comprehensive studies to evaluate the performance of PRF-110. Over a 72-hour industry-standard duration, and extending to 96 hours, PRF-110 exhibited remarkably higher rates of analgesic drug release compared to a market-leading post-surgical pain product. Results indicated that PRF-110 released between 34%-77% more drug over a span of 96 hours under various testing conditions. These results are particularly noteworthy as they not only provide support for PRF-110's superior efficacy but also its potential to significantly extend the duration of pain relief. By ensuring a more consistent and prolonged analgesic effect, PRF-110 aims to reduce the dependency on opiates for post-surgical pain management, addressing a critical need in the healthcare system for safer, more effective pain management strategies. Duyuru • Apr 02
PainReform Ltd. Reaches 50% Enrollment in the Second Part of its Phase 3 Clinical Trial of PRF-110 in Bunionectomy PainReform Ltd. announced it has reached the 50% enrollment target for the second part of Phase 3 clinical trial of PRF-110 in bunionectomy. In total, over 200 patients have been enrolled, of up to approximately 400 patients at eight clinical sites across the U.S. Duyuru • Mar 02
PainReform Ltd. has filed a Follow-on Equity Offering in the amount of $5 million. PainReform Ltd. has filed a Follow-on Equity Offering in the amount of $5 million.
Security Name: Ordinary Shares
Security Type: Common Stock
Security Name: Pre-Funded Warrants
Security Type: Equity Warrant New Risk • Jan 21
New major risk - Shareholder dilution The company's shareholders have been substantially diluted in the past year. Increase in shares outstanding: 91% This is considered a major risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Major Risks Shareholders have been substantially diluted in the past year (91% increase in shares outstanding). Revenue is less than US$1m. Market cap is less than US$10m (US$4.55m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$13m net loss in 3 years). Share price has been volatile over the past 3 months (15% average weekly change). Board Change • Oct 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 4 experienced directors. 1 highly experienced director. Independent External Director Gus Lawlor was the last director to join the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Duyuru • Sep 13
PainReform Ltd. Announces Plans to Commence Second Part of Phase 3 Clinical Trial to Evaluate PRF-110 in Patients Undergoing Bunionectomy Surgery Following Positive FDA Review of Drug Master File PainReform Ltd. announced plans to commence the second part of the Company’s phase 3 trial to evaluate PRF-110 in patients undergoing bunionectomy surgery. Starting the second part of the bunionectomy Phase III study follows the clearance by FDA of the DMF (Drug Master File) held by the Company’s API manufacturer. This second part of the trial is expected to proceed in the next quarter of 2023. As announced earlier this year, the company completed the first part of its Phase 3 clinical trial of PRF-110, in which 15 patients undergoing bunionectomy surgery were enrolled at two clinical sites in Texas. The Company reported positive safety data in the first part of the Phase 3 clinical trial with no serious adverse events (SAEs) reported, suggesting a substantial potential advantage to using PRF-110 over opioids. As previously reported, PRF-110 provided pain reduction for up to 72 hours post-operatively in the Company’s prior Phase 2 proof-of-concept clinical study in herniorrhaphy (hernia repair). The upcoming second part of the trial will be a double-blind study, in which the Company plans to randomize approximately 400 patients at seven clinical sites in the U.S. PRF-110 is a highly uniform solution, resulting in consistent sustained and extended release of the analgesic. Ropivacaine, the active drug used in PRF-110, is a safe, well-tolerated, and well-characterized local anesthetic. The other components that comprise the remainder of the PRF-110 formulation have been designated by the FDA as Generally Recognized as Safe (GRAS), mitigating many potential safety issues common in drug development. Key surgical benefits observed to date include: PRF-110 does not alter the integrity of standard surgical devices, such as sutures and meshes used in a large variety of surgical procedures; PRF-110 does not interfere with normal macro and microscopic wound healing of surgical incisions in soft tissue and bone models; PRF-110 does not alter the tensile strength of healed skin at the surgical sites in an animal study mimicking surgical procedures. Duyuru • Sep 08
PainReform Ltd. Announces Selection for Poster Presentation at the 13th Congress of the European Pain Federation in Budapest, Hungary PainReform Ltd. announced that Company has been selected for a poster presentation, titled “Pharmacokinetics and Safety Profiles of PRF-110 in Subjects Following Bunionectomy Surgery,” at the upcoming 13th Congress of the European Pain Federation (EFIC) being held September 20-22, 2023 at the HUNGEXPO Exhibition Centre in Budapest, Hungary. The poster will be presented by Professor Eli Hazum, Chief Technology Officer of PainReform, on September 20, 2023. The poster will be available on the EFIC website after the meeting. The poster presentation will provide further details regarding the positive safety and pharmacokinetic (PK) data from the Company’s first part of its two-part Phase 3 clinical trial of PRF-110, which enrolled 15 bunionectomy patients at two clinical sites in Texas. PRF-110 was administrated intra-operatively to validate the formulation's safety and confirm optimal product instillation in the surgical wound. PRF 110 was well tolerated, all adverse events (AEs) were mild, and no serious adverse events (SAEs) were observed. The Phase 3 trial is a randomized, double-blind, placebo and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of intra-operative administration of PRF-110 following unilateral bunionectomy. PRF-110 is an oil-based, viscous, clear solution that is deposited directly into the surgical wound bed before closure to provide localized and extended postoperative analgesia. The upcoming second part of the trial will be a double-blind study, randomizing approximately 400 patients at seven clinical sites in the U.S. and measuring pain reduction by PRF-110 over 72 hours compared with placebo and plain ropivacaine. New Risk • Jun 11
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 17% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$7.3m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Earnings are forecast to decline by an average of 17% per year for the foreseeable future. Revenue is less than US$1m. Market cap is less than US$10m (US$5.41m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$20m net loss in 3 years). Shareholders have been diluted in the past year (2.3% increase in shares outstanding). Duyuru • Jun 08
PainReform Ltd. Provides Regulatory Update on Second Part of its Phase 3 Clinical Trial of PRF-110 in Patients Undergoing Bunionectomy Surgery PainReform Ltd. provided a regulatory update on the second part of its Phase 3 clinical trial of PRF-110 in patients undergoing Bunionectomy surgery. The Company's supplier of the API (active pharmaceutical ingredient) has received a deficiency notice from the FDA related to its Drug Master File (DMF). The DMF is the file on record with FDA representing the manufacturing process and facility for the production of the API. As a result, the second part of Phase 3 trial is expected to commence once the required information has been provided by the supplier to the FDA and the deficiency notice has been resolved. None of the issues raised relate to the Company's PRF-110 product. New Risk • Jun 08
New major risk - Financial position The company has less than a year of cash runway based on its current free cash flow trend. Free cash flow: -US$7.3m This is considered a major risk. With less than a year's worth of cash, the company will need to raise capital or take on debt unless its cash flows improve. This would dilute existing shareholders or increase balance sheet risk. Currently, the following risks have been identified for the company: Major Risks Less than 1 year of cash runway based on free cash flow trend (-US$7.3m free cash flow). Share price has been highly volatile over the past 3 months (17% average weekly change). Revenue is less than US$1m. Market cap is less than US$10m (US$5.15m market cap). Minor Risks Currently unprofitable and not forecast to become profitable over next 3 years (US$19m net loss in 3 years). Shareholders have been diluted in the past year (2.3% increase in shares outstanding). Duyuru • May 19
PainReform Ltd. Announces Positive Pharmacokinetic (PK) Data in First Part of Phase 3 Clinical Trial of PRF-110 in Patients Undergoing Bunionectomy Surgery PainReform Ltd. announced positive pharmacokinetic (PK) data in the first part of its two-part Phase 3 clinical trial of PRF-110, which enrolled 15 bunionectomy patients at two clinical sites in Texas. During Part I of this study, blood samples were collected at specified time points post-surgery, through 72 hours, to determine maximum plasma ropivacaine concentrations (Cmax). Cmax value among all of the 15 patients, was approximately 10% of the safety window set by FDA. The Phase 3 trial is a randomized, double-blind, placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of intra-operative administration of PRF-110 following unilateral bunionectomy. PRF-110 is an oil-based, viscous, clear solution that is deposited directly into the surgical wound bed before closure to provide localized and extended postoperative analgesia. The other components that make up the remainder of the PRF-110 formulation have been designated by the FDA as Generally Recognized as Safe (GRAS), by the FDA, mitigating many potential safety issues. Duyuru • May 05
PainReform Ltd., Annual General Meeting, Jun 08, 2023 PainReform Ltd., Annual General Meeting, Jun 08, 2023, at 15:00 Israel Standard Time. Location: offices of the Company's attorneys, Doron Tikotzky Kantor Gutman Nass & Amit Gross 7 Metsada St., B.S.R Tower 4, 33 Floor Bnei Brak Israel Agenda: To approve the re-election of directors; to approve a grant of options; to ratify and approve certain adjustments of the compensation terms of Ilan Hadar, the Chief Executive Officer of the Company; to increase the Company's authorized share capital; to approve a reverse split of the Company ordinary shares; To approve the re-appointment of Kesselman & Kesselman, as the Company's independent registered public accounting firm for the year ending December 31, 2023, and to authorize the Board of Directors, upon the recommendation of the Company's audit committee, to determine the Auditors's remuneration to be fixed in accordance with the volume and nature of their services to the Company for such fiscal year; and to review and discuss Company's financial statements for the year ended December 31, 2022, and to transact such other business as may properly come before the meeting. Duyuru • Feb 09
PainReform Announces Receipt of Extension to Meet the Nasdaq’s Minimum Bid Price Requirement PainReform Ltd. announced that on February 7, 2023, it received a letter from The Nasdaq Stock Market LLC, notifying the Company that it is eligible for an additional 180 calendar day period, or until August 7, 2023, to regain compliance with the Nasdaq’s minimum $1 bid price per share requirement. The Company was first notified by Nasdaq of its failure to maintain a minimum bid price of $1 per share for 30 consecutive trading days under Nasdaq Listing Rule 5550(a)(2) on August 10, 2022, and was given until February 6, 2023 to regain compliance. The Company did not regain compliance with the minimum $1 bid price per share requirement during the first 180-calendar-day compliance period and submitted a written request to the Staff to afford it an additional 180-day compliance period to cure the deficiency. If at any time before August 7, 2023, the bid price of the Company’s ordinary shares closes at or above $1 per share for a minimum of 10 consecutive trading days, the Company will regain compliance with the Nasdaq Listing Rules, and the matter will be closed. Duyuru • Nov 26
PainReform Ltd., Annual General Meeting, Dec 29, 2022 PainReform Ltd., Annual General Meeting, Dec 29, 2022, at 11:00 Israel Standard Time. Location: Metsada St., B.S.R Tower 4, Bnei Brak Benei Brak Israel Agenda: To approve the re-election of Prof. Eli Hazum, Dr. Ehud Geller and Efi Cohen-Arazi, to the board of directors of the Company, each until the next annual general meeting of shareholders; to approve the re-appointment of Kesselman & Kesselman, Certified Public Accountants (Isr.), a member firm of PricewaterhouseCoopers International Limited (the “Auditors”), as the Company’s independent registered public accounting firm for the year ending December 31, 2022, and to authorize the Board of Directors, upon the recommendation of the Company’s audit committee, to determine the Auditors’ remuneration to be fixed in accordance with the volume and nature of their services to the Company for such fiscal year; to ratify and approve the grant of options to Ilan Hadar in his capacity as the Chief Executive Officer of the Company; and to review and discuss our financial statements for the year ended December 31, 2021 , and to transact such other business as may properly come before the meeting. Price Target Changed • Nov 16
Price target decreased to US$3.00 Down from US$6.00, the current price target is provided by 1 analyst. New target price is 445% above last closing price of US$0.55. Stock is down 76% over the past year. The company is forecast to post a net loss per share of US$0.64 next year compared to a net loss per share of US$0.74 last year. Duyuru • Nov 09
PainReform Ltd. Provides Further Update on Manufacturing of PRF-110 PainReform Ltd. provided a further update related to the manufacturing process of clinical batches for PRF-110. As previously announced, the company implemented additional enhancements to manufacturing process for PRF-110 expected to improve the efficiency and scalability of manufacturing. The company have since encountered issues in the manufacturing process, which will result in a delay in the commencement of planned Phase 3 trial. Company is moving aggressively on plans and expect to report further updates as it relates to the expected start of the clinical study as soon as practical. Overall, Company remain highly encouraged by the outlook for the business based on the success of prior Phase 2 proof-of-concept clinical study. Assuming Phase 3 trial is successful, company believe PRF-110 has the potential to become standard-of-care within the $12 billion post-operative pain treatment market and represents a highly attractive alternative to systemic opioids. Duyuru • Oct 06
PainReform Ltd. Provides PRF-110 Manufacturing Update PainReform Ltd. provided an update regarding the added benefits in its PRF-110 manufacturing process. This new process is expected to not only aid the manufacturing of clinical stock for the Phase 3 clinical study about to begin, but also deliver benefits into the future. Duyuru • Aug 17
PainReform Announces Receipt of Nasdaq Minimum Bid Price Notification PainReform Ltd. (“PainReform” or the “Company”) announced that the Company received a letter from the Nasdaq Listing Qualifications (the “Letter”), indicating that the Company is not in compliance with the minimum bid price requirement for continued listing set in Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum bid price of $1.00 per share. Further, the Rules also provide the Company a compliance period of 180 calendar days to regain compliance. According to the Letter, the Company has from August 10, 2022, or until February 6, 2023, to regain compliance with the minimum bid price requirement. The Company can regain compliance, if at any time during this 180-day period, the closing bid price of its ordinary shares is at least $1 for a minimum of ten consecutive business days, in which case the Company will be provided with a written confirmation of compliance and this matter will be closed. In the event the Company does not regain compliance after the initial 180-day period, the Company may then be eligible for an additional time if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period. If the Company cannot demonstrate compliance by the end of the 180-day period, the Nasdaq’s staff will notify the Company that its ordinary shares are subject to delisting. The Letter has no immediate effect on the Company’s Nasdaq listing or the trading of its ordinary shares, and during the grace period, as may be extended, PainReform’s ordinary shares will continue to trade on the Nasdaq Capital Market under the symbol “PRFX”. Price Target Changed • Apr 27
Price target decreased to US$3.00 Down from US$6.00, the current price target is provided by 1 analyst. New target price is 183% above last closing price of US$1.06. Stock is down 69% over the past year. The company is forecast to post a net loss per share of US$2.29 next year compared to a net loss per share of US$0.74 last year. Breakeven Date Change • May 22
Forecast to breakeven in 2025 The analyst covering PainReform expects the company to break even for the first time. New forecast suggests the company will make a profit of US$18.5m in 2025. Average annual earnings growth of 43% is required to achieve expected profit on schedule. Duyuru • Mar 21
PainReform Ltd. announced that it has received $5.999992 million in funding On March 19, 2021, PainReform Ltd. (NasdaqCM:PRFX) closed the transaction. The transaction included participation from 3 investors. Executive Departure • Mar 10
Director has left the company On the 28th of February, Assif Stoffman's tenure as Director ended after 1.2 years in the role. We don't have any record of a personal shareholding under Assif's name. Assif is the only executive to leave the company over the last 12 months. Duyuru • Mar 09
PainReform Ltd. announced that it expects to receive $5.999992 million in funding PainReform Ltd. (NasdaqCM:PRFX) announced that it has entered into securities purchase agreements with certain institutional investors for a private placement of 1,304,346 shares at a price of $4.60 per share for gross proceeds of $5,999,992 on March 8, 2021. The company will also warrants to purchase an aggregate of up to 652,173 ordinary shares at a combined purchase price of $4.60 per share. 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 transaction is expected to occur on March 10, 2021, subject to the satisfaction of certain customary closing conditions. Duyuru • Mar 04
PainReform Ltd. Announces Resignation of Assif Stoffman from Board of Directors February 28, 2021, Assif Stoffman, a member of the board of directors of PainReform Ltd. notified the Company that effective immediately, he resigned from the board of directors. Is New 90 Day High Low • Feb 10
New 90-day high: US$5.66 The company is up 33% from its price of US$4.27 on 11 November 2020. The American market is up 15% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Pharmaceuticals industry, which is up 8.0% over the same period. Duyuru • Jan 08
PainReform Ltd. Appoints Rita Keynan as Vice President of Pharmaceutical Operations PainReform Ltd. announced the appointment of Rita Keynan as Vice President of Pharmaceutical Operations. Mrs. Keynan has been responsible for drug development from early phase trials through NDA filings, including managing all chemistry, manufacturing and control (CMC) activities supporting product development, clinical supplies, scale-up, regulatory submissions and commercial manufacturing. Prior to joining PainReform, Mrs. Keynan served as Executive Director of Drug Development at VYNE Therapeutics Ltd., formerly Foamix Pharmaceuticals, where she managed the drug development department that included a team of nearly a dozen employees in Israel, as well as a contract manufacturing organization (CMO) team in Europe. Is New 90 Day High Low • Jan 07
New 90-day low: US$4.06 The company is down 12% from its price of US$4.60 on 08 October 2020. The American market is up 12% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Pharmaceuticals industry, which is up 6.0% over the same period. Duyuru • Nov 24
PainReform Appoints Ilan Hadar as Chief Executive Officer PainReform Ltd. announced the appointment of Ilan Hadar as Chief Executive Officer. Mr. Hadar brings over 20 years of multinational managerial and corporate experience with pharmaceutical and high-tech companies. Prior to joining PainReform, Mr. Hadar served as Country Manager Israel and CFO at Foamix Pharmaceuticals Ltd. since 2014. Prior to Foamix, Mr. Hadar was Finance Director at Pfizer Pharmaceutical Ltd., where he oversaw all commercial, financial and operational activities of the local entity. From 2007 to 2011, Mr. Hadar served as Finance Manager at HP Indigo Ltd. Prior to that, Mr. Hadar was Finance Director at BAE Systems. Duyuru • Nov 14
PainReform Ltd. Welcomes Ellen Baron as A Member of Board of Directors PainReform Ltd. welcomed Dr. Ellen Baron as a member of the company's board of directors following its recent initial public offering. Dr. Ellen Baron has been a Managing Director at Outcome Capital LLC, a specialized life science and technology strategic advisory and investment banking firm, since February 2017, serving as global head of the Biopharmaceutical practice. From 2012-2017, she served as a Managing Director of Healthios Capital Markets,
LLC. Before joining Healthios, Dr. Baron served as Lifescience Venture Capital Partner at Oxford Bioscience Partners and as Senior Vice President, Business Development at Human Genome Sciences, a publicly traded biopharmaceutical company. Dr. Baron previously spent 20 years at Schering-Plough Corporation in both research and development, as well as business development. Dr. Baron currently serves on the board of directors of Tetragenetics Inc., a biotech company, Sixth Element Capital, UK-based oncology focused venture capital fund, and SFH, a Maine-based nutraceutical company. Duyuru • Nov 10
PainReform Ltd. Appoints Augustine Lawlor as Member of Board of Directors PainReform Ltd. appointed Augustine Lawlor as a member of the company’s Board of Directors following its recent initial public offering. Mr. Lawlor has served as Chief Operating Officer of Leap Therapeutics Inc., an oncology company, since January 2016 and has been a Managing Director of HealthCare Ventures since 2000. From 1997 to 2000. Duyuru • Sep 02
PainReform Ltd. has completed an IPO in the amount of $20 million. PainReform Ltd. has completed an IPO in the amount of $20 million.
Security Name: Units
Security Type: Equity/Derivative Unit
Price\Range: $8
Discount Per Security: $0.56
Security Name: Units
Security Type: Equity/Derivative Unit
Price\Range: $8
Discount Per Security: $0.28
Transaction Features: Sponsor Backed Offering 