PainReform(PRFX) - 2023 Q4 - Annual Report

PART I ITEM 3. KEY INFORMATION This section details significant risks to the company's financial viability, drug development, intellectual property, and operations, including its going concern status and reliance on PRF-110 D. Risk Factors The company faces substantial risks, including a "going concern" warning, dependence on its sole product PRF-110, geopolitical instability, and potential Nasdaq delisting - The company's independent registered public accounting firm has issued a "going concern" explanatory paragraph, indicating substantial doubt about its ability to continue operations without raising additional capital. As of December 31, 2023, the company had $8.0 million in cash and cash equivalents and believes it only has sufficient resources to fund operations through the third quarter of 2024[53][61][341] - The company is entirely dependent on the success of its initial product candidate, PRF-110, which is currently in a Phase 3 clinical trial. Any failure or significant delay in its development or commercialization would materially harm the business[48][68][69] - The company has previously faced non-compliance with Nasdaq's minimum bid price requirement of $1.00 per share, receiving a notice in August 2022. While compliance was regained in July 2023, failure to maintain this requirement in the future could lead to delisting[162][164] - The ongoing military conflict between Israel and Hamas, which began in October 2023, presents a significant risk. While operations have not been adversely affected to date, a prolonged or expanded conflict could harm business conditions, results of operations, and the ability to raise capital[134][135][136] - U.S. shareholders face a risk that the company could be characterized as a Passive Foreign Investment Company (PFIC). While the company believes it was not a PFIC for the 2023 taxable year, this status is determined annually and could result in adverse U.S. federal income tax consequences for U.S. investors if it becomes a PFIC in the future[192] Historical Net Losses | Year Ended December 31 | Net Loss (in millions) | | :--- | :--- | | 2023 | $9.3 | | 2022 | $8.8 | | 2021 | $7.2 | | Accumulated Deficit as of Dec 31, 2023 | $41.9 | ITEM 4. INFORMATION ON THE COMPANY PainReform is a clinical-stage pharmaceutical company focused on reformulating therapeutics with its proprietary extended-release system, with PRF-110 as its lead product A. History and Development of the Company PainReform Ltd., incorporated in Israel in 2007, is a clinical-stage specialty pharmaceutical company leveraging its proprietary extended-release drug-delivery system - The company was incorporated in Israel in November 2007 and focuses on reformulating established therapeutics for extended post-surgical pain relief[199][200] - PainReform is classified as an "emerging growth company" and a "foreign private issuer," which permits it to take advantage of certain exemptions from U.S. reporting requirements[202][203] B. Business Overview The company's business centers on PRF-110, an extended-release ropivacaine formulation for post-operative pain, utilizing the FDA's 505(b)(2) pathway and targeting a multi-billion dollar market - The company's lead product candidate is PRF-110, an extended-release, oil-based solution of the local anesthetic ropivacaine, designed for post-operative pain relief[206] - PainReform utilizes the FDA's 505(b)(2) regulatory pathway, which allows it to rely in part on existing data for the approved drug (ropivacaine), potentially reducing development time and cost[206][218] - The first Phase 3 clinical trial for PRF-110 in bunionectomy patients began in March 2023. After a delay caused by an FDA query to its API supplier, the trial resumed patient enrollment in October 2023. A second Phase 3 trial in hernia repair is planned upon successful completion of the first[208][209][210] - The North American post-operative pain treatment market was estimated at $12 billion and is projected to reach $16 billion by 2026[212] - Key competitors in the post-operative pain market include Exparel® (Pacira), Zynrelief® (Heron Therapeutics), and several other products in development by companies like Durect, Innocoll, and Vertex Pharmaceuticals[248] C. Organizational Structure The company currently operates without any subsidiaries - The company currently has no subsidiaries[306] D. Property, Plants and Equipment The company leases approximately 2,300 square feet of office space in Tel Aviv, Israel, with its current lease expiring in August 2024 - The company's principal facilities consist of approximately 2,300 square feet of leased office space in Tel Aviv, Israel[307] - The lease expires in August 2024, with an annual cost of approximately $66 thousand[307] ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS This section analyzes the company's financial condition and operations, highlighting its history of net losses, increased R&D expenses, and significant liquidity concerns with a going concern warning A. Operating Results The company reported a net loss of $9.3 million in 2023, primarily driven by increased research and development expenses for PRF-110, with no revenue generated Results of Operations (in thousands of U.S. dollars) | | 2023 | 2022 | 2021 | | :--- | :--- | :--- | :--- | | Research and development | $6,035 | $4,422 | $2,860 | | General and administrative | $3,549 | $4,447 | $4,348 | | Total operating loss | $9,584 | $8,869 | $7,208 | | Net loss | $9,344 | $8,792 | $7,246 | - Research and development expenses increased by $1.6 million (36.4%) in 2023 compared to 2022, mainly due to a $3.2 million increase in clinical trials and manufacturing expenses for PRF-110[330] - General and administrative expenses decreased by $0.8 million (18.2%) in 2023 compared to 2022, primarily due to lower insurance costs and professional services fees[332] B. Liquidity and Capital Resources The company faces significant liquidity challenges, including a going concern warning, with current cash sufficient only through Q3 2024, necessitating further capital raises - There is substantial doubt about the company's ability to continue as a going concern, with sufficient resources to fund operations only through the end of Q3 2024[341][353] - In 2023, the company raised gross proceeds of $5.6 million through two registered direct offerings and a warrant exercise transaction[316] Key Liquidity Metrics (as of Dec 31, 2023) | Metric | Amount (in millions) | | :--- | :--- | | Cash and cash equivalents | $8.0 | | Accumulated deficit | $41.9 | | Positive working capital | $7.4 | Cash Flow Summary (in thousands of U.S. dollars) | | 2023 | 2022 | 2021 | | :--- | :--- | :--- | :--- | | Net cash used in operating activities | ($6,679) | ($6,459) | ($6,553) | | Net cash provided by (used in) investing activities | $5,991 | ($6,006) | ($50) | | Net cash provided by financing activities | $4,616 | $0 | $7,484 | Contractual Obligations (as of Dec 31, 2023) | Obligation | Payments Due (in thousands) | | :--- | :--- | | Master clinical research organization agreement | $2,192 | | Master clinical trial agreement | $6,991 | | Total | $9,183 | E. Critical Accounting Estimates Critical accounting estimates involve significant judgment in areas such as clinical trial accruals, income taxes, and share-based compensation, reflecting the company's operational complexities - Key accounting estimates include clinical trial accruals, which are based on the progress of trials as reported by external vendors like CROs[374][375] - The company has recorded a full valuation allowance against its net deferred tax assets due to its history of losses and uncertainty regarding future taxable income. As of December 31, 2023, it had net operating loss (NOL) carryforwards of approximately $24.8 million[376][377] - Share-based compensation is calculated using the Black-Scholes model, requiring significant assumptions for variables like expected share price volatility and option term[378] ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES This section details the company's leadership, compensation practices, and board structure, including key management, aggregate compensation, and board committee composition A. Directors and Senior Management The company's leadership comprises key senior management and a six-member Board of Directors, including two external directors as mandated by Israeli law - Key senior management includes Ilan Hadar (CEO & CFO), Prof. Eli Hazum (CTO & Director), Dr. Sigal Aviel (COO), and Rita Keynan (VP of Pharmaceutical Operations)[381] - The Board of Directors is chaired by Dr. Ehud Geller and includes two external directors, Dr. Ellen S. Baron and Augustine Lawlor, as required by Israeli law[381] B. Compensation Aggregate compensation for senior management and directors totaled approximately $2.2 million in 2023, with detailed compensation for top executives provided Aggregate Compensation for Senior Management and Directors (2023) | Compensation Type | Amount (in thousands of U.S. dollars) | | :--- | :--- | | Salaries, fees, commissions, and bonuses | $1,269 | | Pension, retirement and similar benefits | $160 | | Value of Options Granted | $776 | | Total | $2,205 | Individual Compensation of Top Executives (2023) | Name and Position | Total Compensation (in thousands of U.S. dollars) | | :--- | :--- | | Ilan Hadar, CEO | $562 | | Rita Keynan, VP Operations | $353 | | Sigal Aviel, COO | $352 | | Ehud Geller, Chairman | $276 | | Eli Hazum, CTO | $270 | C. Board Practices The board of directors, comprising six members including two external directors, operates with established Audit and Compensation Committees and defined policies for director and officer protection - The Board of Directors currently consists of six directors, including two external directors (Dr. Ellen Baron and Augustine Lawlor) as required by Israeli Companies Law[408][414] - The Audit Committee is comprised of Efi Cohen-Arazi, Dr. Ellen Baron, and Augustine Lawlor (Chairman). Mr. Lawlor is designated as the "audit committee financial expert"[430] - The Compensation Committee is comprised of Efi Cohen-Arazi (Chairperson), Dr. Ellen Baron, and Augustine Lawlor. It is responsible for establishing and overseeing the company's compensation policy[439][440] - The company has adopted policies for exculpation, insurance, and indemnification for its directors and officers to the fullest extent permitted by Israeli law[475][479] D. Employees As of December 31, 2023, the company had seven full-time employees across R&D, operations, and administration, maintaining good employee relations - As of December 31, 2023, the company had seven full-time employees[305] E. Share Ownership The company maintains share incentive plans, with options for 177,133 ordinary shares outstanding under the 2019 Plan as of February 29, 2024 - The 2008 PainReform Option Plan has expired, but as of Feb 29, 2024, options to purchase 15,388 shares remain outstanding under this plan[483] - Under the active 2019 PainReform Option Plan, as of Feb 29, 2024, options for 177,133 ordinary shares were outstanding, and 24,813 were available for future issuance[484] ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS This section outlines the company's ownership structure, including major shareholders and beneficial ownership by management, along with details of related party transactions A. Major Shareholders As of February 29, 2024, major shareholders included Medica III Investment group, Armistice Capital, and XT Hi-Tech Investments, with management holding 25.7% beneficial ownership Major Shareholders (as of February 29, 2024) | Shareholder | Percentage Owned | | :--- | :--- | | Medica III Investment group | 19.9% | | Armistice Capital, LLC | 9.99% | | XT Hi-Tech Investments (1992) Ltd. | 6.2% | | All senior management and directors as a group | 25.7% | - As of February 29, 2024, there were 1,728,347 ordinary shares outstanding[493] B. Related Party Transactions Material related party transactions involve the Medica III Investment group and standard agreements with the company's directors and executive officers - The Medica III Investment group, a major shareholder, held approximately 19.1% of the company's shares as of December 31, 2023. Prof. Eli Hazum, the company's CTO, has been a partner at Medica Venture Partners since 1995[498] - The company has entered into indemnification, employment, and option agreements with its directors and executive officers[499][500] ITEM 8. FINANCIAL INFORMATION This section refers to the detailed financial statements in Item 18, confirming no material legal proceedings and no intention to pay future cash dividends - The company has never declared or paid cash dividends and does not intend to in the foreseeable future, planning to reinvest any earnings into the business[503] - The company is not currently a party to any material legal proceedings[304][502] ITEM 9. THE OFFER AND LISTING The company's ordinary shares commenced trading on the Nasdaq Capital Market under the ticker "PRFX" on September 1, 2020 - The company's ordinary shares are listed on the Nasdaq Capital Market under the trading symbol "PRFX" since September 1, 2020[505][506] ITEM 10. ADDITIONAL INFORMATION This section covers additional corporate details, including material contracts, exchange controls, and a detailed summary of Israeli and U.S. tax considerations for shareholders E. Taxation This subsection provides a detailed overview of Israeli and U.S. federal income tax considerations, including corporate tax rates, capital gains, dividends, and the risk of Passive Foreign Investment Company (PFIC) classification - The general corporate tax rate in Israel is 23%. The company may be eligible for reduced rates under programs like the Preferred Enterprise or Preferred Technology Enterprise regimes if it generates taxable income in the future[516][520][524] - For Israeli residents, the capital gains tax rate on the sale of shares is generally 25%, or 30% for a "substantial shareholder." The dividend tax rate is also 25% (or 30% for a substantial shareholder)[530][537] - Non-Israeli residents are generally exempt from Israeli capital gains tax on the sale of shares listed on a foreign exchange, subject to certain conditions. Under the U.S.-Israel Tax Treaty, U.S. residents are generally exempt from this tax unless they hold 10% or more of the voting power or meet other specific criteria[533][534] - The company believes it was not a Passive Foreign Investment Company (PFIC) for U.S. federal income tax purposes for its 2023 taxable year. However, PFIC status is an annual determination, and if the company were to be classified as a PFIC, it could result in adverse tax consequences for U.S. Holders[562] ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK The company is exposed to market risks, primarily foreign exchange risk from multi-currency operations and significant liquidity risk, including a going concern warning - The company is exposed to foreign exchange risk as some operational expenses are in New Israeli Shekel (NIS) and Euro, while its functional currency is the U.S. dollar[585] - Significant liquidity risk exists, with substantial doubt about the company's ability to continue as a going concern. Current cash is expected to fund operations only through Q3 2024, requiring additional capital to complete its clinical trials[586] ITEM 15. CONTROLS AND PROCEDURES Management concluded that disclosure controls and internal control over financial reporting were effective as of December 31, 2023, with an auditor attestation exemption as an emerging growth company - Management concluded that as of December 31, 2023, the company's disclosure controls and procedures were effective[593] - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2023[594] - The annual report does not include an auditor's attestation report on internal control over financial reporting, as the company is exempt as an emerging growth company[595] ITEM 16. Other Information This section covers governance and compliance, including the audit committee financial expert, principal accountant fees, Nasdaq exemptions, and cybersecurity risk management - The Board of Directors has determined that Augustine Lawlor is an audit committee financial expert[597] Principal Accountant Fees (in thousands of USD) | Fee Type | 2023 | 2022 | | :--- | :--- | :--- | | Audit fees | $120 | $107 | | Audit-related fees | $122 | $5 | | All other fees | $0 | $23 | | Total | $242 | $135 | - As a foreign private issuer, the company follows its home country (Israel) corporate governance practices in lieu of certain Nasdaq listing rules, including those related to shareholder approval, director nominations, and quorum requirements[608][609] - In Q2 2022, the company experienced a cybersecurity incident where a third party impersonated a supplier, resulting in a fraudulent wire transfer of $165 thousand. The company recovered most of the payment and has since enhanced its internal controls[616] PART III ITEM 18. FINANCIAL STATEMENTS This section indicates the inclusion of a full set of financial statements and related notes as required by Item 18 at the end of the annual report - The company has elected to provide financial statements and related information pursuant to Item 18, which are included starting on page F-1 of the report[618][619] ITEM 19. EXHIBITS This section lists all exhibits filed as part of the annual report, including corporate governance documents, material agreements, and required certifications - A comprehensive list of exhibits is provided, including corporate governance documents, material contracts, and required SEC certifications[620][621]