TEL AVIV, Israel, Aug. 01, 2024 (GLOBE NEWSWIRE) -- PainReform Ltd. (Nasdaq: PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, announces 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 ...

TEL AVIV, Israel, July 24, 2024 (GLOBE NEWSWIRE) -- PainReform Ltd. (NASDAQ:PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced it has filed a patent covering its new and highly scalable manufacturing process for PRF-110, its flagship product designed to revolutionize post-operative pain control. The patent filing follows successful completion and testing of the new process. This milestone not only ...

TEL AVIV, Israel, June 26, 2024 (GLOBE NEWSWIRE) -- PainReform Ltd. (NASDAQ:PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced 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 ...

TEL AVIV, Israel, May 31, 2024 (GLOBE NEWSWIRE) -- PainReform Ltd. (NASDAQ:PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today announced that 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 forth in Listing Rule 5550(a)(2), which requires listed securities to ...

Exhibit 99.1 PAINREFORM LTD. CONDENSED FINANCIAL STATEMENTS AS OF MARCH 31, 2024 U.S. DOLLARS IN THOUSANDS UNAUDITED INDEX | | Page | | --- | --- | | Condensed Balance Sheets | F-2 | | Condensed Statements of Comprehensive Loss | F-3 | | Condensed Statements of Changes in Shareholders' Equity | F-4 | | Condensed Statements of Cash Flows | F-5 | | Notes to Condensed Financial Statements | F-6 - F-10 | PAINREFORM LTD. CONDENSED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited) U.S. dollars in thousands (except sha ...

Reaches 50% enrollment in the second part of its Phase 3 clinical trial of PRF-110 in bunionectomy Remains on track to announce top-line data in Q3 2024 TEL AVIV, Israel, May 15, 2024 (GLOBE NEWSWIRE) -- PainReform Ltd. (NASDAQ:PRFX) ("PainReform" or the "Company"), a clinical-stage specialty pharmaceutical company focused on the reformulation of established therapeutics, today provided a business update for the first quarter ended March 31, 2024. Ilan Hadar, Chief Executive Officer of PainReform, stated, " ...

PART I [ITEM 3. KEY INFORMATION](index=7&type=section&id=ITEM%203.%20KEY%20INFORMATION) 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](index=7&type=section&id=D.%20Risk%20Factors) 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](index=53&type=chunk)[61](index=61&type=chunk)[341](index=341&type=chunk) - 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](index=48&type=chunk)[68](index=68&type=chunk)[69](index=69&type=chunk) - 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](index=162&type=chunk)[164](index=164&type=chunk) - 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](index=134&type=chunk)[135](index=135&type=chunk)[136](index=136&type=chunk) - 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](index=192&type=chunk) 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](index=39&type=section&id=ITEM%204.%20INFORMATION%20ON%20THE%20COMPANY) 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](index=39&type=section&id=A.%20History%20and%20Development%20of%20the%20Company) 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](index=199&type=chunk)[200](index=200&type=chunk) - 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](index=202&type=chunk)[203](index=203&type=chunk) [B. Business Overview](index=40&type=section&id=B.%20Business%20Overview) 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](index=206&type=chunk) - 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](index=206&type=chunk)[218](index=218&type=chunk) - 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](index=208&type=chunk)[209](index=209&type=chunk)[210](index=210&type=chunk) - The North American post-operative pain treatment market was estimated at **$12 billion** and is projected to reach **$16 billion** by 2026[212](index=212&type=chunk) - 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](index=248&type=chunk) [C. Organizational Structure](index=58&type=section&id=C.%20Organizational%20Structure) The company currently operates without any subsidiaries - The company currently has no subsidiaries[306](index=306&type=chunk) [D. Property, Plants and Equipment](index=58&type=section&id=D.%20Property,%20Plants%20and%20Equipment) 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](index=307&type=chunk) - The lease expires in August 2024, with an annual cost of approximately **$66 thousand**[307](index=307&type=chunk) [ITEM 5. OPERATING AND FINANCIAL REVIEW AND PROSPECTS](index=59&type=section&id=ITEM%205.%20OPERATING%20AND%20FINANCIAL%20REVIEW%20AND%20PROSPECTS) 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](index=62&type=section&id=A.%20Operating%20Results) 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](index=330&type=chunk) - 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](index=332&type=chunk) [B. Liquidity and Capital Resources](index=64&type=section&id=B.%20Liquidity%20and%20Capital%20Resources) 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](index=341&type=chunk)[353](index=353&type=chunk) - In 2023, the company raised gross proceeds of **$5.6 million** through two registered direct offerings and a warrant exercise transaction[316](index=316&type=chunk) 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](index=69&type=section&id=E.%20Critical%20Accounting%20Estimates) 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](index=374&type=chunk)[375](index=375&type=chunk) - 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](index=376&type=chunk)[377](index=377&type=chunk) - Share-based compensation is calculated using the Black-Scholes model, requiring significant assumptions for variables like expected share price volatility and option term[378](index=378&type=chunk) [ITEM 6. DIRECTORS, SENIOR MANAGEMENT AND EMPLOYEES](index=70&type=section&id=ITEM%206.%20DIRECTORS,%20SENIOR%20MANAGEMENT%20AND%20EMPLOYEES) 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](index=70&type=section&id=A.%20Directors%20and%20Senior%20Management) 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](index=381&type=chunk) - 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](index=381&type=chunk) [B. Compensation](index=72&type=section&id=B.%20Compensation) 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](index=75&type=section&id=C.%20Board%20Practices) 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](index=408&type=chunk)[414](index=414&type=chunk) - 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](index=430&type=chunk) - 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](index=439&type=chunk)[440](index=440&type=chunk) - The company has adopted policies for exculpation, insurance, and indemnification for its directors and officers to the fullest extent permitted by Israeli law[475](index=475&type=chunk)[479](index=479&type=chunk) [D. Employees](index=88&type=section&id=D.%20Employees) 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](index=305&type=chunk) [E. Share Ownership](index=88&type=section&id=E.%20Share%20Ownership) 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](index=483&type=chunk) - 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](index=484&type=chunk) [ITEM 7. MAJOR SHAREHOLDERS AND RELATED PARTY TRANSACTIONS](index=89&type=section&id=ITEM%207.%20MAJOR%20SHAREHOLDERS%20AND%20RELATED%20PARTY%20TRANSACTIONS) 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](index=89&type=section&id=A.%20Major%20Shareholders) 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](index=493&type=chunk) [B. Related Party Transactions](index=92&type=section&id=B.%20Related%20Party%20Transactions) 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](index=498&type=chunk) - The company has entered into indemnification, employment, and option agreements with its directors and executive officers[499](index=499&type=chunk)[500](index=500&type=chunk) [ITEM 8. FINANCIAL INFORMATION](index=93&type=section&id=ITEM%208.%20FINANCIAL%20INFORMATION) 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](index=503&type=chunk) - The company is not currently a party to any material legal proceedings[304](index=304&type=chunk)[502](index=502&type=chunk) [ITEM 9. THE OFFER AND LISTING](index=94&type=section&id=ITEM%209.%20THE%20OFFER%20AND%20LISTING) 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](index=505&type=chunk)[506](index=506&type=chunk) [ITEM 10. ADDITIONAL INFORMATION](index=94&type=section&id=ITEM%2010.%20ADDITIONAL%20INFORMATION) 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](index=95&type=section&id=E.%20Taxation) 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](index=516&type=chunk)[520](index=520&type=chunk)[524](index=524&type=chunk) - 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](index=530&type=chunk)[537](index=537&type=chunk) - 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](index=533&type=chunk)[534](index=534&type=chunk) - 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](index=562&type=chunk) [ITEM 11. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK](index=107&type=section&id=ITEM%2011.%20QUANTITATIVE%20AND%20QUALITATIVE%20DISCLOSURES%20ABOUT%20MARKET%20RISK) 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](index=585&type=chunk) - 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](index=586&type=chunk) [ITEM 15. CONTROLS AND PROCEDURES](index=107&type=section&id=ITEM%2015.%20CONTROLS%20AND%20PROCEDURES) 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](index=593&type=chunk) - Management concluded that the company's internal control over financial reporting was effective as of December 31, 2023[594](index=594&type=chunk) - 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](index=595&type=chunk) [ITEM 16. Other Information](index=108&type=section&id=ITEM%2016.%20Other%20Information) 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](index=597&type=chunk) 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](index=608&type=chunk)[609](index=609&type=chunk) - 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](index=616&type=chunk) PART III [ITEM 18. FINANCIAL STATEMENTS](index=113&type=section&id=ITEM%2018.%20FINANCIAL%20STATEMENTS) 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](index=618&type=chunk)[619](index=619&type=chunk) [ITEM 19. EXHIBITS](index=113&type=section&id=ITEM%2019.%20EXHIBITS) 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](index=620&type=chunk)[621](index=621&type=chunk)

Exhibit 99.1 PAINREFORM LTD. CONDENSED FINANCIAL STATEMENTS AS OF SEPTEMBER 30, 2023 U.S. DOLLARS IN THOUSANDS UNAUDITED INDEX | | Page | | --- | --- | | Condensed Balance Sheets | F-2 | | Condensed Statements of Comprehensive Loss | F-3 | | Condensed Statements of Changes in Shareholders' Equity | F-4 | | Condensed Statements of Cash Flows | F-5-F-6 | | Notes to Condensed Financial Statements | F-7 - F-13 | PAINREFORM LTD. CONDENSED BALANCE SHEETS U.S. dollars in thousands | | | | As of | | As of | | --- | ...

[Financial Statements](index=2&type=section&id=Financial%20Statements) This section presents the company's condensed balance sheets, statements of comprehensive loss, changes in shareholders' equity, and cash flows [Condensed Balance Sheets](index=2&type=section&id=Condensed%20Balance%20Sheets) The company's balance sheet as of June 30, 2023, shows a decrease in total assets and shareholders' equity compared to December 31, 2022, primarily driven by a reduction in current assets, particularly short-term deposits Condensed Balance Sheets (in thousands) | Metric | As of June 30, 2023 (in thousands) | As of December 31, 2022 (in thousands) | Change (2023 vs 2022) | | :-------------------------------- | :---------------------------------- | :----------------------------------- | :-------------------- | | Total assets | $8,316 | $12,328 | -$4,012 | | Total current assets | $8,278 | $12,284 | -$4,006 | | Cash and cash equivalents | $5,138 | $4,096 | +$1,042 | | Short term deposit | $1,014 | $6,085 | -$5,071 | | Total liabilities | $1,343 | $1,307 | +$36 | | Total shareholders' equity | $6,973 | $11,021 | -$4,048 | [Condensed Statements of Comprehensive Loss](index=3&type=section&id=Condensed%20Statements%20of%20Comprehensive%20Loss) For the six months ended June 30, 2023, the company experienced an increased net loss and comprehensive loss compared to the same period in 2022, primarily due to higher research and development expenses, partially offset by financial income Condensed Statements of Comprehensive Loss (in thousands) | Metric | For the Six Months Ended June 30, 2023 (in thousands) | For the Six Months Ended June 30, 2022 (in thousands) | Change (2023 vs 2022) | | :------------------------------------ | :-------------------------------------------------- | :-------------------------------------------------- | :-------------------- | | Research and development expenses | $(2,700) | $(1,423) | -$(1,277) | | General and administrative expenses | $(1,968) | $(2,094) | +$126 | | Operating loss | $(4,668) | $(3,517) | -$(1,151) | | Financial income, net | $179 | $- | +$179 | | Net loss and comprehensive loss | $(4,489) | $(3,517) | -$(972) | | Basic and diluted net loss per share | $(4.12) | $(3.25) | -$(0.87) | [Condensed Statements of Changes in Shareholders' Equity](index=4&type=section&id=Condensed%20Statements%20of%20Changes%20in%20Shareholders%27%20Equity) Shareholders' equity decreased significantly from $11,021 thousand at January 1, 2023, to $6,973 thousand by June 30, 2023, primarily due to the net loss incurred during the period, partially offset by share-based compensation Condensed Statements of Changes in Shareholders' Equity (in thousands) | Metric | Balance as of January 1, 2023 (in thousands) | Balance as of June 30, 2023 (in thousands) | Change | | :------------------------------------ | :----------------------------------------- | :---------------------------------------- | :------- | | Total shareholders' equity | $11,021 | $6,973 | -$4,048 | | Accumulated deficit | $(32,519) | $(37,008) | -$(4,489) | | Additional paid-in capital | $43,446 | $43,887 | +$441 | | Share-based compensation to employees and directors (6 months ended June 30, 2023) | N/A | $441 | N/A | | Net loss and comprehensive loss (6 months ended June 30, 2023) | N/A | $(4,489) | N/A | - The number of issued and outstanding ordinary shares increased from **1,081,755** as of December 31, 2022, to **1,090,452** as of June 30, 2023, reflecting share issuance to service providers and adjustments from a reverse share split[3](index=3&type=chunk)[7](index=7&type=chunk) [Condensed Statements of Cash Flows](index=5&type=section&id=Condensed%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2023, the company significantly reduced its net cash used in operating activities compared to the prior year, while investing activities provided a substantial cash inflow, leading to an overall increase in cash and cash equivalents Condensed Statements of Cash Flows (in thousands) | Metric | For the Six Months Ended June 30, 2023 (in thousands) | For the Six Months Ended June 30, 2022 (in thousands) | Change (2023 vs 2022) | | :------------------------------------------ | :-------------------------------------------------- | :-------------------------------------------------- | :-------------------- | | Net cash used in operating activities | $(3,955) | $(2,699) | -$(1,256) | | Net cash provided by investing activities | $5,000 | $(3) | +$5,003 | | Change in cash, cash equivalents and restricted cash | $1,042 | $(2,702) | +$3,744 | | Cash, cash equivalents and restricted cash at end of period | $5,148 | $13,869 | -$8,721 | - The positive cash flow from investing activities in 2023 was primarily driven by proceeds from short-term deposits (**$6,000 thousand**), offsetting purchases of short-term deposits (**$1,000 thousand**)[9](index=9&type=chunk) [Notes to Condensed Unaudited Financial Statements](index=6&type=section&id=Notes%20to%20Condensed%20Unaudited%20Financial%20Statements) This section provides detailed notes explaining the company's financial statements, including significant accounting policies, going concern issues, and subsequent events [NOTE 1: GENERAL](index=6&type=section&id=NOTE%201%3A%20GENERAL) PainReform Ltd. is a clinical-stage specialty pharmaceutical company focused on post-surgical pain relief. The company has incurred significant losses and negative cash flows, raising substantial doubt about its ability to continue as a going concern, necessitating further capital raising. Additionally, the second part of its Phase 3 clinical trial faces delays due to an FDA deficiency notice to its API supplier - The Company is a clinical stage specialty pharmaceutical company focused on the reformulation of established therapeutics, aiming to provide extended post-surgical pain relief without repeated dose administration and reduce opiate use[15](index=15&type=chunk) - The Company has incurred significant losses and negative cash flows from operations, with net losses of **$4,489 thousand** and **$3,517 thousand** for the six-month periods ended June 30, 2023 and 2022, respectively[11](index=11&type=chunk) - As of June 30, 2023, the accumulated deficit was **$37,008 thousand**, and the Company does not have sufficient resources to fund operations until the end of its Phase III study, raising substantial doubt about its ability to continue as a going concern[11](index=11&type=chunk)[13](index=13&type=chunk) - Management plans to continue capital raising through equity, debt, or strategic partnerships, but there are no assurances of obtaining the necessary financing[14](index=14&type=chunk) - The second part of the Phase 3 trial for PRF-110 is expected to commence once the FDA resolves a deficiency notice issued to the Company's API supplier, which does not relate to the PRF-110 product itself[14](index=14&type=chunk) [NOTE 2: UNAUDITED CONDENSED FINANCIAL STATEMENTS](index=7&type=section&id=NOTE%202%3A%20UNAUDITED%20CONDENSED%20FINANCIAL%20STATEMENTS) These unaudited condensed financial statements are prepared in accordance with U.S. GAAP, consistent with the annual report, but omit certain disclosures. They reflect management's necessary adjustments and are not indicative of future results. The company is exposed to foreign exchange risk due to Israeli operations and has retroactively applied a 1-for-10 reverse share split. Global market volatility from geopolitical tensions is also noted as a potential risk - The unaudited condensed financial statements are prepared in accordance with U.S. GAAP, consistent with the Company's 2022 Annual Report on Form 20-F, but certain information and disclosures normally included in annual financial statements have been omitted[17](index=17&type=chunk)[18](index=18&type=chunk) - Operating results for the six months ended June 30, 2023, are not necessarily indicative of the results that may be expected for the full year or any other future period[20](index=20&type=chunk) - The Company is exposed to exchange rate risks between the New Israeli Shekel (NIS) and the U.S. dollar, which could materially affect financial results, although Israeli inflation did not have a material adverse effect during the periods presented[21](index=21&type=chunk) - In June 2023, the Company effected a **1-for-10 reverse share split**, and all related share and per share data have been retroactively applied to the financial statements for all periods presented[21](index=21&type=chunk) - U.S. and global markets are experiencing volatility and disruption due to geopolitical tensions and the military conflict between Russia and Ukraine, which could affect the Company's business, financial condition, and operating results[21](index=21&type=chunk) [NOTE 3: SIGNIFICANT ACCOUNTING POLICIES](index=8&type=section&id=NOTE%203%3A%20SIGNIFICANT%20ACCOUNTING%20POLICIES) The significant accounting policies applied in these unaudited condensed financial statements are consistent with those used in the Company's most recent annual financial statements - The significant accounting policies applied in the preparation of these unaudited condensed financial statements are consistent with those used in the Company's most recent annual financial statements in connection with its Annual Report on Form 20-F[22](index=22&type=chunk) [NOTE 4: SHAREHOLDERS' EQUITY](index=8&type=section&id=NOTE%204%3A%20SHAREHOLDERS%27%20EQUITY) This note details the company's outstanding warrants and share-based compensation plans, including options granted to employees and directors. It also confirms the retroactive application of a 1-for-10 reverse share split to all share-related data [Warrants and warrants units](index=8&type=section&id=Warrants%20and%20warrants%20units) As of June 30, 2023, the company had 3,950,217 warrants outstanding with various issuance dates, exercise prices, and expiration dates, including IPO, PIPE, and underwriter warrants Warrants Outstanding as of June 30, 2023 | Type | Issuance Date | Number of warrants | Exercise price (**) | Exercisable through | | :-------------------------------- | :---------------- | :----------------- | :------------------ | :------------------ | | August 2019 warrants | August 22, 2019 | 205,268 | $67.2 (*) | August 22, 2024 | | December 2019 warrants | December 9, 2019 | 92,321 | $67.2 (*) | December 8, 2024 | | Warrants 2019 Convertible Notes to placement agent | December 9, 2019 | 55,785 | $67.2 (*) | December 8, 2024 | | Warrants to underwriters | September 3, 2020 | 125,000 | $100.0 | September 1, 2025 | | Warrants to underwriters | October 5, 2020 | 375,000 | $88.0 | September 3, 2025 | | IPO warrants | September 3, 2020 | 2,812,170 | $88.0 | September 3, 2025 | | PIPE warrants | March 11, 2021 | 232,500 | $46.0 | September 10, 2026 | | Warrants to PIPE placement agent | March 11, 2021 | 52,173 | $50.6 | March 8, 2026 | | **TOTAL** | | **3,950,217** | | | - All exercise prices have been retroactively adjusted to reflect a **1-for-10 reverse share split**[24](index=24&type=chunk) [Share-based compensation](index=9&type=section&id=Share-based%20compensation) The company maintains two share option plans (2008 and 2019 Plans) for employees and directors. In June 2023, 54,000 options were granted to board members under the 2019 Plan at an exercise price of $5.89 per share, with a grant-date fair value of $3.20 per option 2008 Share Option Plan (Options Outstanding and Exercisable) | Metric | As of June 30, 2023 | As of December 31, 2022 | | :-------------------------------- | :------------------ | :-------------------- | | Options outstanding | 15,388 | 15,388 | | Weighted average exercise price | $2.40 | $2.40 | | Weighted average remaining contractual life | 0.75 years | 1.25 years | | Options exercisable | 15,388 | 15,388 | 2019 Share Option Plan (Options Outstanding and Exercisable) | Metric | As of June 30, 2023 | As of December 31, 2022 | | :-------------------------------- | :------------------ | :-------------------- | | Options outstanding | 187,994 | 133,994 | | Weighted average exercise price | $11.94 | $14.4 | | Weighted average remaining contractual life | 9.20 years | 9.39 years | | Options exercisable | 116,416 | 133,994 | - On June 8, 2023, shareholders approved the grant of **54,000 options** to two current board members and the Chairman, each receiving **18,000 options** at an exercise price of **$5.89 per share**. Fifty percent vested upon grant, with the remainder vesting quarterly over 36 months[27](index=27&type=chunk) - The grant-date fair value for the June 2023 options was **$3.20 per option**, based on an average expected term of **5.36 years**, a risk-free interest rate of **3.85%**, volatility of **90.43%**, and zero dividend yield[27](index=27&type=chunk) - A **1-for-10 reverse share split** was effected in June 2023, consolidating shares and retroactively adjusting all related share and per share data in the financial statements and notes for all periods presented[34](index=34&type=chunk) [NOTE 5: LOSS PER SHARE](index=11&type=section&id=NOTE%205%3A%20LOSS%20PER%20SHARE) Basic loss per share is calculated based on net loss and weighted average ordinary shares. For the periods ended June 30, 2023, and 2022, all outstanding share options, restricted shares, and warrants were anti-dilutive and thus excluded from the diluted loss per share calculation - Basic loss per share is computed by dividing the net loss by the weighted average number of Ordinary Shares and vested Ordinary Shares issuable for little or no further consideration outstanding during the period[30](index=30&type=chunk) - For the six months ended June 30, 2023, and 2022, all outstanding share options, restricted shares, and warrants were excluded from the calculation of diluted net loss per share because they were anti-dilutive[31](index=31&type=chunk) [NOTE 6: COMMITMENTS AND CONTINGENCIES](index=11&type=section&id=NOTE%206%3A%20COMMITMENTS%20AND%20CONTINGENCIES) The company has agreements with Lotus Clinical Research for its Phase 3 trials of PRF-110, with updated milestone and subject payment terms. Clinical trial expenses are recognized as incurred, with prepaid amounts recorded. Additionally, the company issued shares to a consultant in February 2023 - The Company entered into Master Clinical Research Organization Agreements with Lotus Clinical Research for its planned Phase 3 trials of PRF-110, which commenced in March 2023[32](index=32&type=chunk) - The total milestone completion payment was updated to **$5.6 million**, and the payment for the actual number of evaluable subjects was updated to **$8.6 million**[32](index=32&type=chunk) - Clinical trial expenses are charged to research and development expenses as incurred. As of June 30, 2023, **$1,962 thousand** was accounted for as prepaid clinical trial expenses, and **$2,042 thousand** was recognized as clinical trial expenses during the six months ended June 2023[33](index=33&type=chunk)[34](index=34&type=chunk) - In February 2023, the Company issued **8,697 Ordinary Shares** to a consultant in connection with a second grant approved in May 2022[34](index=34&type=chunk) [NOTE 7: FINANCIAL INCOME, NET](index=12&type=section&id=NOTE%207%3A%20FINANCIAL%20INCOME%2C%20NET) For the six months ended June 30, 2023, the company reported net financial income of $179 thousand, primarily driven by interest income, a significant increase compared to the prior year Financial Income, Net (in thousands) | Metric | Six Months ended June 30, 2023 (in thousands) | Six Months ended June 30, 2022 (in thousands) | | :------------------------ | :------------------------------------------ | :------------------------------------------ | | Bank fees | $(8) | $(7) | | Interest income | $190 | $- | | Exchange rate differences | $(3) | $7 | | **Total financial income, net** | **$179** | **$-** | [NOTE 8: FINANCIAL INSTRUMENTS](index=12&type=section&id=NOTE%208%3A%20FINANCIAL%20INSTRUMENTS) The carrying amounts of the company's cash equivalents, restricted cash, trade payables, and accrued expenses are considered to approximate their fair value due to their short-term nature - The carrying amount of cash equivalents, restricted cash, account payables, and accrued expenses approximate their fair value due to their short-term characteristics[36](index=36&type=chunk) [NOTE 9: SUBSEQUENT EVENTS](index=12&type=section&id=NOTE%209%3A%20SUBSEQUENT%20EVENTS) In July 2023, the company completed two registered direct offerings and concurrent private placements of warrants, raising approximately $4.2 million in gross proceeds and $3.6 million in net proceeds. These transactions involved the sale of ordinary shares and pre-funded warrants, which were fully exercised - On July 14, 2023, the Company sold **117,930 Ordinary Shares** and pre-funded warrants for **183,300 Ordinary Shares** in a registered direct offering and private placement, generating gross proceeds of approximately **$2.7 million** and net proceeds of **$2.3 million**[38](index=38&type=chunk) - On July 18, 2023, another registered direct offering and private placement resulted in the sale of **145,000 Ordinary Shares** and pre-funded warrants for **21,666 Ordinary Shares**, yielding gross proceeds of approximately **$1.5 million** and net proceeds of **$1.3 million**[38](index=38&type=chunk) - Both offerings included the issuance of unregistered warrants to purchase additional Ordinary Shares at an exercise price of **$9.00 per share**, and all pre-funded warrants were exercised in full[38](index=38&type=chunk)

Exhibit 99.1 PAINREFORM LTD. CONDENSED FINANCIAL STATEMENTS AS OF MARCH 31, 2023 U.S. DOLLARS IN THOUSANDS UNAUDITED F - 2 PAINREFORM LTD. CONDENSED STATEMENTS OF COMPREHENSIVE LOSS U.S. dollars in thousands (except share and per share data) INDEX | | Page | | --- | --- | | Condensed Balance Sheets | F-2 | | Condensed Statements of Comprehensive Loss | F-3 | | Condensed Statements of Changes in Shareholders' Equity | F-4 | | Condensed Statements of Cash Flows | F-5 | | Notes to Condensed Financial Statement ...