Company Overview - PainReform Ltd. is a clinical-stage specialty pharmaceutical company that has expanded into the Smart Energy Management (SEM) sector following the acquisition of DeepSolar, which provides AI-driven software solutions for optimizing solar energy usage [1][2][7] - The company aims to leverage its AI expertise to address new verticals, focusing on data-centric platforms that drive recurring revenue and operational scalability [6] Strategic Expansion - The expansion into the SEM sector is part of PainReform's long-term diversification strategy to tap into high-growth, tech-enabled markets [2][5] - This move aligns with global energy trends, particularly the increasing demand for decentralized and sustainable energy solutions, as well as the growing global solar capacity [2][5] DeepSolar Product Offering - DeepSolar's MyDeepSolar application utilizes machine learning and predictive analytics for real-time monitoring, yield forecasting, and performance optimization of solar systems [3][4] - The application provides homeowners with insights into their solar system's performance, maximizing returns on solar investments and optimizing energy efficiency [4] Market Context - The entry into the SEM market occurs amid significant M&A activity and institutional investments in solar and smart energy technologies, with governments increasing support for residential optimization through various incentives [5] - The optimization software is seen as a foundational tool in the transition to sustainable energy, providing both economic and environmental value [2]

Core Insights - PainReform Ltd. is expanding into the Smart Energy Management (SEM) sector following the acquisition of DeepSolar, which specializes in AI-driven software for optimizing solar energy usage [1][2][5] - This strategic move is part of PainReform's long-term diversification strategy aimed at entering high-growth, tech-enabled markets, particularly in response to the increasing global demand for decentralized and sustainable energy solutions [2][6] Company Overview - PainReform is a clinical-stage specialty pharmaceutical company that focuses on reformulating established therapeutics and developing AI-driven energy optimization technologies through its DeepSolar platform [7] - The company aims to leverage its expertise in AI to create data-centric platforms that drive recurring revenue and operational scalability in the SEM sector [6][7] Product Details - DeepSolar's MyDeepSolar application utilizes machine learning and predictive analytics for real-time monitoring, yield forecasting, and performance optimization of solar energy systems [3][4] - The application provides homeowners with insights into their solar system's performance, maximizing returns on solar investments and enhancing energy efficiency [4] Market Context - The expansion into SEM aligns with global energy trends and capitalizes on a technology platform with significant commercial scalability [5] - There is a growing trend of mergers and acquisitions in the solar and smart energy technology sectors, supported by government incentives for residential optimization [5]

[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].