[Business Update and Strategic Overview](index=1&type=section&id=Business%20Update%20and%20Strategic%20Overview) PainReform provided a 2024 year-end business update, detailing a strategic shift towards high-margin technology sectors via the DeepSolar acquisition, continued PRF-110 drug development, and Nasdaq compliance efforts [Introduction and Key Strategic Shifts](index=1&type=section&id=Introduction%20and%20Key%20Strategic%20Shifts) PainReform provided a year-end business update for 2024, highlighting a strategic shift towards investing in high-margin, technology-driven sectors, exemplified by the DeepSolar acquisition, while continuing to advance its lead drug candidate, PRF-110 - PainReform is expanding its strategy to include high-margin, technology-driven sectors[3](index=3&type=chunk) - The company provided a business update for the year ended December 31, 2024[2](index=2&type=chunk) [PRF-110 Clinical Development Update](index=1&type=section&id=PRF-110%20Clinical%20Development%20Update) The company remains committed to advancing PRF-110 for post-operative pain relief despite a temporary setback in its Phase 3 bunionectomy trial, focusing on addressing a 24-hour data gap and refining the drug's pharmacokinetics and pharmacodynamics - PainReform is committed to advancing PRF-110 for extended post-operative pain relief[3](index=3&type=chunk) - Encountered a temporary setback in Phase 3 clinical trial for PRF-110 in bunionectomy patients[3](index=3&type=chunk) - Launched R&D activities to refine PRF-110's pharmacokinetics and pharmacodynamics based on trial data[3](index=3&type=chunk) [DeepSolar Acquisition and Clean Energy Expansion](index=1&type=section&id=DeepSolar%20Acquisition%20and%20Clean%20Energy%20Expansion) PainReform acquired DeepSolar, an AI-driven solar analytics platform, marking its expansion into the high-growth clean energy sector with expectations for scalable SaaS platform revenue growth and strategic partnerships - Acquired DeepSolar, an AI-driven solar analytics platform, expanding into the clean energy sector[3](index=3&type=chunk) - Expects DeepSolar's scalable SaaS platform to drive revenue growth[3](index=3&type=chunk) - Intends to explore strategic partnerships with utility companies, solar technology providers, and smart grid operators[3](index=3&type=chunk) [Nasdaq Listing Compliance](index=1&type=section&id=Nasdaq%20Listing%20Compliance) Following a notice of non-compliance with Nasdaq's minimum shareholders' equity requirement, PainReform believes it has regained compliance after a $0.9 million ATM raise and the DeepSolar acquisition, and is committed to maintaining its listing standards - Received Nasdaq notice for non-compliance with **$2.5 million** minimum shareholders' equity[4](index=4&type=chunk) - Believes shareholders' equity now exceeds the required threshold after a **$0.9 million** ATM raise and DeepSolar acquisition[4](index=4&type=chunk) [Financial Results for the Year Ended December 31, 2024](index=1&type=section&id=Financial%20Results%20for%20the%20Year%20Ended%20December%2031%2C%202024) The company reported increased R&D expenses and a higher net loss in 2024, while general and administrative expenses decreased, maintaining a positive working capital position [Research and Development Expenses](index=1&type=section&id=Research%20and%20Development%20Expenses) R&D expenses significantly increased in 2024, primarily due to higher clinical trial and manufacturing costs, partially offset by reduced subcontractor and consultant expenses Research and Development Expenses | Year | Amount (approx.) | Change (YoY) | Primary Reason for Change | | :--- | :--- | :--- | :--- | | 2024 | $11.7 million | +$5.7 million | Increase in clinical trial costs and manufacturing expenses, offset by decrease in subcontractors and consultants' expenses | | 2023 | $6.0 million | | | [General and Administrative Expenses](index=1&type=section&id=General%20and%20Administrative%20Expenses) General and administrative expenses decreased in 2024, mainly attributable to lower insurance costs and share-based compensation expenses General and Administrative Expenses | Year | Amount (approx.) | Change (YoY) | Primary Reason for Change | | :--- | :--- | :--- | :--- | | 2024 | $3.0 million | -$0.6 million | Decrease due to insurance costs and share-based compensation expenses | | 2023 | $3.6 million | | | [Financial Income, Net](index=1&type=section&id=Financial%20Income%2C%20Net) Net financial income decreased in 2024 compared to 2023, primarily due to a reduction in cash holdings Financial Income, Net | Year | Amount (approx.) | Change (YoY) | Primary Reason for Change | | :--- | :--- | :--- | :--- | | 2024 | $93,000 | -$155,000 | Decrease due to lower cash in 2024 | | 2023 | $248,000 | | | [Net Loss and Working Capital](index=1&type=section&id=Net%20Loss%20and%20Working%20Capital) PainReform reported a higher net loss in 2024 compared to 2023, but maintained a positive working capital of approximately $2.0 million as of year-end Net Loss | Year | Amount (approx.) | Change (YoY) | | :--- | :--- | :--- | | 2024 | $14.6 million | +$5.3 million | | 2023 | $9.3 million | | - Company had a positive working capital of approximately **$2.0 million** as of December 31, 2024[8](index=8&type=chunk) [Company Information and Disclosures](index=1&type=section&id=Company%20Information%20and%20Disclosures) This section details the filing of the 2024 annual report, provides an overview of PainReform's business, includes forward-looking statements, and lists contact information [Annual Report Filing](index=1&type=section&id=Annual%20Report%20Filing) PainReform filed its annual report on Form 20-F for the year ended December 31, 2024, with the SEC and made it available on its investor relations website, offering hard copies to shareholders upon request - Annual report on Form 20-F for 2024 filed with SEC and available on investor relations website[9](index=9&type=chunk) - Hard copies of the annual report are available to shareholders upon request[9](index=9&type=chunk) [About PainReform](index=2&type=section&id=About%20PainReform) PainReform is a specialty pharmaceutical company focused on reformulating established therapeutics, utilizing a proprietary extended-release drug-delivery system for post-surgical pain relief, and recently expanded into AI-driven solar analytics with the DeepSolar acquisition - PainReform is a specialty pharmaceutical company focused on reformulating established therapeutics[10](index=10&type=chunk) - Develops a proprietary extended-release drug-delivery system for post-surgical pain relief[10](index=10&type=chunk) - Acquired DeepSolar, an AI-driven solar analytics technology, in March 2025[10](index=10&type=chunk) [Forward-Looking Statements](index=2&type=section&id=Forward-Looking%20Statements) The press release includes forward-looking statements regarding PainReform's expectations, beliefs, and intentions, particularly concerning the DeepSolar acquisition's benefits and market opportunities, and cautions readers about inherent risks and uncertainties - Press release contains forward-looking statements about PainReform's expectations, beliefs, and intentions, including anticipated benefits of DeepSolar acquisition[11](index=11&type=chunk) - Forward-looking statements are subject to risks and uncertainties, and actual results may differ materially[11](index=11&type=chunk) [Contact Information](index=2&type=section&id=Contact%20Information) Contact details for investor relations (Crescendo Communications) and PainReform's Chairman and interim CEO, Dr. Ehud Geller, are provided for inquiries - Contact information for investor relations and company management is provided[12](index=12&type=chunk)

Financial Performance and Risks - The company has never generated revenues and may never be profitable, indicating a significant risk for investors[51]. - The independent registered public accounting firm's report contains an explanatory paragraph regarding substantial doubt about the company's ability to continue as a going concern[51]. - The company has incurred significant losses and negative cash flows from operations since inception and expects to continue incurring losses for the foreseeable future[54]. - As of December 31, 2024, the company had total cash and cash equivalents of $4.2 million, raising substantial doubt about its ability to continue as a going concern[63]. - The company incurred losses of approximately $14.6 million, $9.3 million, and $8.8 million for the years ended December 31, 2024, 2023, and 2022, respectively, with an accumulated deficit of $56.5 million as of December 31, 2024[64]. - The company expects to continue incurring losses for the foreseeable future, particularly as it initiates clinical trials for PRF-110 and expands its DeepSolar business[65]. - The company will require substantial additional funding to support ongoing operations and product development, with no committed external sources of funds currently available[68]. - Future capital requirements will depend on the costs and outcomes of clinical trials, regulatory reviews, and commercialization activities for PRF-110 and the DeepSolar business[72]. - The company may need to raise additional capital through equity offerings or debt financings, which could dilute shareholder ownership and impose operational restrictions[74]. Product Development and Clinical Trials - The company is dependent on the success of its initial product candidate, PRF-110, and any delays in obtaining approval or commercialization could materially harm the business[54]. - The company has limited experience in conducting and managing clinical trials necessary for obtaining regulatory approvals, which poses a risk to its drug development efforts[54]. - The Phase 3 clinical trial for PRF-110 did not meet its primary endpoint, necessitating further research and development to refine its pharmacokinetics and pharmacodynamics[77]. - The company has not yet commercialized any pharmaceutical products and may never achieve profitability, depending on various factors including regulatory approvals and market acceptance[82]. - The company relies on third-party service providers for clinical trials, and any failure on their part could delay or prevent the development and commercialization of its products[95]. - The company has faced issues with its former contract manufacturing organization (CMO) in Israel, leading to a shift of manufacturing operations to North America[95]. - The company commenced its Phase 3 clinical trial of PRF-110 in March 2023 after overcoming manufacturing process issues[95]. - Market acceptance of PRF-110 will depend on its advantages over existing treatments and the effectiveness of marketing efforts[98]. Competition and Market Conditions - The company may face intense competition in the AI software market, which could limit its ability to develop a customer base and generate revenue[54]. - The pharmaceutical industry is highly competitive, and the company may face challenges if competitors develop more effective or less expensive products[99]. - The company faces intense competition from established players like Power Factors and Meteocontrol, which have greater financial resources and market presence[144]. Regulatory and Legislative Environment - Legislative and regulatory changes in the U.S. healthcare system could impact the profitability and marketability of PRF-110[106]. - The Bipartisan Budget Act of 2018 increased the point-of-sale discount for Medicare Part D beneficiaries from 50% to 70% during the coverage gap[108]. - The Budget Control Act of 2011 led to aggregate reductions in Medicare payments to providers of up to 2% per fiscal year, effective through 2030[109]. - The Inflation Reduction Act of 2022 allows Medicare to negotiate prices for certain high-expenditure drugs, with a maximum of 20 drugs subject to negotiation by 2029[110]. - Legislative changes may result in additional reductions in Medicare and healthcare funding, impacting the pricing and availability of drug products[112]. DeepSolar Business and Market Adoption - In March 2025, the company acquired DeepSolar, an AI-driven solar analytics technology, which is in the early stage of commercialization and presents unpredictable future performance[60]. - The DeepSolar business, acquired in March 2025, is in early commercialization stages and has generated limited revenues to date[125]. - The market for the DeepSolar solution is new and unproven, with future success dependent on market adoption and customer acceptance[127]. - The AI-based software market is relatively new and may face limited growth, impacting the demand for DeepSolar technology[129]. - Regulatory scrutiny over AI technologies may increase, potentially affecting the adoption and marketability of the DeepSolar solution[130]. - The sales cycle for the DeepSolar solution is long and unpredictable, requiring significant time and expense for customer evaluation and education[133]. - The company has generated limited revenue to date and lacks adequate sales and marketing infrastructure for the DeepSolar solution[135]. - The future success of the DeepSolar solution is uncertain, as it depends on the widespread adoption of solar energy technologies and sufficient market demand[151]. - The company must enhance the DeepSolar brand and increase market awareness to achieve broader market acceptance[142]. Internal Controls and Compliance - The company has identified a material weakness in its internal control over financial reporting, which could impair the reliability of its financial statements[58]. - A material weakness in internal control over financial reporting has been identified, which could impair the company's ability to produce timely and accurate financial statements[216]. - The material weakness is attributed to insufficient finance staff and incomplete segregation of duties[217]. - Management concluded that internal control over financial reporting was ineffective as of December 31, 2024[217]. - Company plans to hire additional accounting and finance personnel or provide training for new hires to remediate the material weakness[218]. - There is no assurance that remediation measures will be sufficient to prevent future material weaknesses[218]. - Failure to maintain effective internal control could lead to restatements of financial statements and loss of investor confidence[218]. - Independent registered public accounting firm will not attest to the effectiveness of internal controls until the company is no longer an "emerging growth company"[219]. - Inability to comply with Section 404 of the Sarbanes-Oxley Act may result in adverse reports from the independent registered public accounting firm[219]. - Failure to remediate existing weaknesses could negatively affect the market price of the company's ordinary shares and warrants[219]. - Potential investigations by Nasdaq, SEC, or other regulatory authorities could arise from ineffective internal controls[219]. Geopolitical and Economic Factors - The ongoing geopolitical instability, including military conflicts, may adversely affect the company's operations and market conditions[58]. - Political instability in Israel, including recent conflicts, may adversely affect the company's business conditions and financial results[175]. - The company operates in a period of economic uncertainty and capital markets disruption, significantly impacted by geopolitical instability, including military conflicts in Israel and Ukraine[204]. - The company is exposed to various international legal and political risks due to its global operations[195]. Intellectual Property and Technology Risks - The company relies on proprietary technology and faces risks related to intellectual property rights and potential infringement claims[153]. - The company has patent protection for PRF-110, but its DeepSolar business lacks any patents or patent applications, which may adversely affect its ability to commercialize products[156]. - Changes in patent laws or their interpretation could diminish the company's ability to protect its inventions and affect the value of its intellectual property[157]. - The patent prosecution process is expensive and complex, and the company may not be able to maintain or enforce all necessary patent applications[158]. - The natural expiration of a utility patent in the U.S. is generally 20 years from its earliest effective filing date, which limits the lifespan of patent protection[159]. - The company relies on third parties for its intellectual property, increasing the risk of misappropriation or disclosure of trade secrets[164]. Employee and Organizational Challenges - The loss of key personnel could negatively impact the company's business and product development capabilities[85]. - The company may incur significant costs to attract and retain qualified employees, which is critical for its future success[86]. - The company may face operational inefficiencies if it fails to manage growth effectively, which could lead to increased costs and impact financial results[138]. - The company may face challenges in enforcing non-competition agreements with former employees, potentially affecting competitive positioning[184]. - Compensation for employee inventions may be determined by the Israeli Patents Office, impacting future revenue from R&D[185]. - Shareholder rights are governed by Israeli law, which may differ from U.S. corporate governance standards[186].

Core Viewpoint - PainReform Ltd. is advancing its clinical development of PRF-110 while expanding into the clean energy sector through the acquisition of DeepSolar, aiming for long-term shareholder value and revenue growth [2][9]. Business Update - The company is focused on the clinical development of PRF-110, targeting post-operative pain relief, and has faced a temporary setback in its Phase 3 clinical trial for bunionectomy patients [2]. - PainReform has launched R&D activities to refine the pharmacokinetics and pharmacodynamics of PRF-110 based on trial data [2]. Financial Performance - Research and development expenses increased to approximately $11.7 million for the year ended December 31, 2024, from approximately $6.0 million in 2023, primarily due to higher clinical trial and manufacturing costs [4]. - General and administrative expenses decreased to approximately $3.0 million in 2024 from approximately $3.6 million in 2023, mainly due to lower insurance and share-based compensation costs [5]. - The net loss for 2024 was approximately $14.6 million, compared to a net loss of approximately $9.3 million in 2023 [6]. Compliance and Equity - PainReform received a notice from Nasdaq regarding non-compliance with the minimum shareholders' equity requirement of $2.5 million but believes its equity now exceeds this threshold following a $0.9 million raise and the DeepSolar acquisition [3]. Company Overview - PainReform is a specialty pharmaceutical company focused on reformulating established therapeutics and has recently acquired DeepSolar, an AI-driven solar analytics platform [9].

Core Viewpoint - PainReform's acquisition of DeepSolar positions the company as a potential leader in the high-growth, high-margin AI solar energy management sector while maintaining its focus on pharmaceutical innovation [1][4]. Company Overview - PainReform is a clinical-stage specialty pharmaceutical company focused on reformulating established therapeutics, particularly in post-surgical pain relief [9]. - The company has successfully acquired 100% of DeepSolar, an AI-driven solar analytics platform, from BladeRanger Ltd [1][2]. Acquisition Details - The acquisition allows PainReform to enter the clean energy sector, leveraging DeepSolar's software to optimize solar farm efficiency and profitability [2]. - DeepSolar's AI analytics platform enhances energy production and reduces operational inefficiencies, integrating with SCADA systems for monitoring and predictive maintenance [3][6]. - The transaction involved PainReform issuing 178,769 ordinary shares and 223,792 pre-funded warrants to BladeRanger Ltd as part of the acquisition [7]. Market Potential - The solar energy market is projected to grow at an annual rate of 25.32%, generating over 1 terawatt (TW) of energy from 2021 to 2026 [3]. - The residential solar market reached a valuation of $94.2 billion in 2024 and is expected to grow at 8% annually through 2034 [3]. Strategic Goals - PainReform aims to broaden DeepSolar's customer base, targeting utility-scale solar operators, independent power producers, and residential solar users [2]. - The company plans to explore strategic partnerships with utility companies, solar technology providers, and smart grid operators to drive revenue growth [4][5]. - DeepSolar's SaaS model is expected to generate steady, high-margin revenue streams while reducing operational costs for customers by up to 30% [6]. Technological Differentiation - DeepSolar's AI capabilities provide a competitive advantage in the renewable energy market, positioning PainReform as a potential technology leader in solar asset optimization [6].

Core Viewpoint - PainReform Ltd. has announced a strategic acquisition of DeepSolar, an AI-driven solar analytics platform, which is expected to enhance its growth potential while maintaining its commitment to pharmaceutical innovation [1][5][12]. Company Overview - PainReform is a clinical-stage specialty pharmaceutical company focused on reformulating established therapeutics, particularly in pain management [14]. - DeepSolar is an AI-powered analytics company that optimizes the efficiency and profitability of solar energy assets through proprietary software and automation tools [2][3]. Acquisition Details - The acquisition agreement includes the transfer of all rights, intellectual property, customer relations, and the "My DeepSolar" application to PainReform [6][11]. - In exchange, BladeRanger Ltd. will receive 178,769 ordinary shares of PainReform, representing 9.9% of its issued share capital, along with various warrants [7][8]. Market Opportunity - The global residential solar market was valued at $94.2 billion in 2024 and is projected to grow at an annual rate of 8% until 2034 [15]. - DeepSolar's technology can reduce operational costs by up to 30%, significantly improving profitability for solar asset owners [3][15]. Strategic Rationale - The acquisition is seen as a unique opportunity for PainReform to enter a high-margin, rapidly growing sector, leveraging DeepSolar's advanced AI capabilities to enhance solar energy efficiency [5][12]. - PainReform aims to capitalize on the technological advantages of DeepSolar to position itself for long-term growth while continuing its focus on pharmaceutical innovation [12][13].

Core Viewpoint - PainReform Ltd. announced that its Phase 3 clinical trial for PRF-110 in post-surgical pain management did not meet the primary endpoint due to unclear data from the final 24-hour period, but the company is initiating R&D activities to refine the drug's pharmacokinetics and pharmacodynamics [2][6][7] Group 1: Clinical Trial Update - The Phase 3 clinical trial initially reported statistically significant superiority of PRF-110 over placebo in reducing pain during the first 48 hours post-surgery [6] - The final 24-hour data was unclear, preventing the study from meeting its primary endpoint of a 72-hour follow-up [2][6] - The company is focused on resolving the data issues through high-level in-vitro models before proceeding with additional clinical work [7] Group 2: Product Information - PRF-110 is based on the local anesthetic ropivacaine and is designed for postoperative pain relief [7] - The product features an oil-based, viscous solution that is applied directly into the surgical wound to provide localized and extended analgesia [7] - The proprietary extended-release drug-delivery system aims to reduce the need for repeated doses and minimize opioid use [7] Group 3: Future Directions - The company is committed to leveraging learnings from the trial to enhance PRF-110's profile for future evaluations [7] - Ongoing R&D efforts are aimed at deepening the understanding of PRF-110's pharmacological properties [7] - PainReform is also reviewing its strategic options, although there is no assurance that this will lead to enhanced shareholder value [7]

Core Insights - PainReform Ltd. has received partial topline data from its Phase 3 clinical trial for PRF-110, which is aimed at managing post-surgical pain in patients undergoing bunionectomy [1][2] - Initial analysis shows PRF-110 has statistically significant superiority over placebo in reducing pain during the first 48 hours post-surgery, indicating its potential effectiveness [2][4] - There are unresolved data issues regarding the subsequent 24-hour period, which is critical for assessing the primary endpoint of the trial [3] Company Overview - PainReform is a clinical-stage specialty pharmaceutical company focused on reformulating established therapeutics, with PRF-110 being its lead product based on ropivacaine [6] - PRF-110 is designed to provide prolonged pain relief while minimizing the need for opioids, potentially enhancing patient recovery and safety in post-surgical settings [4][6] Clinical Trial Details - The Phase 3 trial is a randomized, double-blind, placebo- and active-controlled study involving 428 patients, with PRF-110 administered intra-operatively [5] - The primary efficacy endpoint is the mean area under the curve (AUC) of pain intensity scores over 72 hours, with secondary endpoints including opioid consumption and the proportion of opioid-free subjects [5]

Core Viewpoint - PainReform Ltd. has received a notification from Nasdaq indicating it no longer meets the minimum stockholders' equity requirement for continued listing, but this has no immediate effect on its trading status [1][2]. Company Overview - PainReform is a clinical-stage specialty pharmaceutical company focused on reformulating established therapeutics, with its lead product PRF-110 targeting postoperative pain relief [3]. - PRF-110 is an oil-based, viscous solution designed for direct application into surgical wounds to provide localized and extended pain relief, potentially reducing the need for opiates [3]. Nasdaq Notification Details - The company has 45 days from the notification date to submit a plan to regain compliance with the Minimum Equity Rule or an alternative listing standard, with a deadline of December 19, 2024 [2]. - If the plan is accepted, Nasdaq may grant an extension of up to 180 days, allowing compliance to be achieved by May 3, 2025 [2].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Form 6-K Report of Foreign Private Issuer Pursuant to Rule 13a-16 or 15d-16 of the Securities Exchange Act of 1934 For the month of September 2024 Commission File Number: 001-39481 PainReform Ltd. (Translation of registrant's name into English) 65 Yigal Alon St., Tel Aviv 6744316 Israel (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F. Washington, D.C. 2 ...

Core Insights - PainReform Ltd. announced positive findings regarding the compatibility of its lead product PRF-110 with surgical sutures in human clinical trials, indicating its potential for extended, non-opiate post-surgical pain relief [1][4] Group 1: Product and Clinical Trials - PRF-110 is designed to provide extended post-surgical pain relief without the use of opiates, utilizing a proprietary extended-release drug-delivery system [5] - Comprehensive in vitro studies were conducted to assess the impact of PRF-110 on both nonabsorbable (PROLENE™) and resorbable (Vicryl™) sutures, focusing on mechanical properties such as breaking force and elongation [2] - Results showed that PRF-110 does not affect the mechanical properties of either type of suture, suggesting compatibility with surgical conditions [3] Group 2: Company Leadership and Future Directions - Ehud Geller, Chairman and interim CEO, emphasized the importance of these findings as a milestone for the safety and efficacy of PRF-110, advancing the product toward commercialization [4] - The ability to provide extended pain relief without compromising suture integrity is highlighted as a significant advancement in post-surgical care [4]