Document And Entity Information
Document And Entity Information | 12 Months Ended |
Dec. 31, 2023 shares | |
Entity Registrant Name | PAINREFORM LTD |
Document Type | 20-F |
Document Fiscal Period Focus | FY |
Document Period End Date | Dec. 31, 2023 |
Entity Well-known Seasoned Issuer | No |
Entity Shell Company | false |
Entity Central Index Key | 0001801834 |
Entity Filer Category | Non-accelerated Filer |
Amendment Flag | false |
Current Fiscal Year End Date | --12-31 |
Entity Current Reporting Status | Yes |
Entity Incorporation, State or Country Code | L3 |
Document Fiscal Year Focus | 2023 |
Entity Emerging Growth Company | true |
Entity Voluntary Filers | No |
Entity File Number | 001-39481 |
Document Annual Report | true |
Entity Common Stock, Shares Outstanding | 1,728,347 |
Entity Interactive Data Current | Yes |
Trading Symbol | PRFX |
Security Exchange Name | NASDAQ |
Entity Ex Transition Period | true |
Title of 12(b) Security | Ordinary shares, par value NIS 0.3 per share |
Entity Address, City or Town | Tel Aviv |
Entity Address, Address Line One | 65 Yigal Alon St., |
Entity Address, Postal Zip Code | 6744316 |
Entity Address, Country | IL |
Document Accounting Standard | U.S. GAAP |
Document Registration Statement | false |
Document Shell Company Report | false |
Document Financial Statement Error Correction [Flag] | false |
ICFR Auditor Attestation Flag | false |
Document Transition Report | false |
Auditor Firm ID | 1309 |
Auditor Location | Tel-Aviv, Israel |
Auditor Name | Kesselman & Kesselman |
Business Contact [Member] | |
Contact Personnel Email Address | ihadar@painreform.com |
Entity Address, City or Town | Tel Aviv |
Entity Address, Address Line One | 65 Yigal Alon St. |
Contact Personnel Name | Ilan Hadar |
Entity Address, Postal Zip Code | 6744316 |
Entity Address, Country | IL |
BALANCE SHEETS
BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | |
Current assets: | |||
Cash and cash equivalents | $ 8,026 | $ 4,096 | |
Short term deposit | 0 | 6,085 | |
Restricted cash | 10 | 10 | |
Prepaid clinical trial expenses and deferred clinical trial costs | 1,514 | 1,728 | |
Prepaid expenses and other current assets | 249 | 365 | |
Total current assets | 9,799 | 12,284 | |
Non-current assets | |||
Operating lease right of use asset | 93 | ||
Property and equipment, net | 38 | 44 | |
Total long-term assets | 131 | 44 | |
Total assets | 9,930 | 12,328 | |
Current liabilities: | |||
Trade payables | 221 | 209 | |
Employees and related liabilities | 465 | 499 | |
Operating lease liability | 56 | ||
Accrued expenses | 1,668 | 356 | |
Total current liabilities | 2,410 | 1,064 | |
Non-current liabilities: | |||
Operating lease liability | 30 | ||
Provision for unrecognized tax positions | 251 | 243 | |
Total non-current liabilities | 281 | 243 | |
Total liabilities | 2,691 | 1,307 | |
Commitments | |||
Shareholders’ Equity: | |||
Ordinary shares, NIS 0.3 par value; Authorized: 5,000,000 and 2,666,667 shares as of December 31, 2023, and 2022, respectively; Issued and outstanding: 1,728,347 and 1,081,755 shares as of December 31, 2023, and 2022, respectively (*) | [1] | 147 | 94 |
Additional paid-in capital | 48,955 | 43,446 | |
Accumulated deficit | (41,863) | (32,519) | |
Total shareholders’ equity | 7,239 | 11,021 | |
Total liabilities and shareholders’ equity | $ 9,930 | $ 12,328 | |
[1]All share amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split (Note 1c) |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) | Dec. 31, 2023 ₪ / shares shares | Dec. 31, 2023 $ / shares shares | Dec. 31, 2022 ₪ / shares shares |
Statement of Financial Position [Abstract] | |||
Ordinary shares, par value (in New Shekels per share) | (per share) | ₪ 0.3 | $ 9 | ₪ 0.3 |
Ordinary shares, shares authorized | 5,000,000 | 5,000,000 | 2,666,667 |
Ordinary shares, shares issued | 1,728,347 | 1,728,347 | 1,081,755 |
Ordinary shares, shares outstanding | 1,728,347 | 1,728,347 | 1,081,755 |
STATEMENTS OF COMPREHENSIVE LOS
STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | ||
Operating expenses: | ||||
Research and development expenses | $ (6,035) | $ (4,422) | $ (2,860) | |
General and administrative expenses | (3,549) | (4,447) | (4,348) | |
Operating loss | (9,584) | (8,869) | (7,208) | |
Financial income (expenses), net | 248 | 86 | (32) | |
Loss before taxes | (9,336) | (8,783) | (7,240) | |
Income tax expenses | (8) | (9) | (6) | |
Net loss and comprehensive loss | $ (9,344) | $ (8,792) | $ (7,246) | |
Basic and diluted net loss per share basic | $ (7.14) | $ (8.13) | $ (7.25) | |
Basic and diluted net loss per share diluted | $ (7.14) | $ (8.13) | $ (7.25) | |
Weighted average number of Ordinary Share used in computing basic net loss per share | [1] | 1,308,920 | 1,081,755 | 999,562 |
Weighted average number of Ordinary Share used in computing diluted net loss per share | [1] | 1,308,920 | 1,081,755 | 999,562 |
[1]All share amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split (Note 1c) |
STATEMENTS OF CHANGES IN SHAREH
STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY - USD ($) $ in Thousands | Common Stock [Member] | Additional paid-in capital [Member] | Accumulated deficit [Member] | Total | |||
Balance at Dec. 31, 2020 | $ 78 | [1] | $ 33,023 | $ (16,481) | $ 16,620 | ||
Balance (in shares) at Dec. 31, 2020 | [1] | 894,142 | |||||
Share-based compensation to employees and directors | $ 0 | [1] | 812 | 0 | 812 | ||
Share-based compensation to service providers | 0 | [1] | 412 | 0 | 412 | ||
Shares and warrants issuance - Private Investment in Public Equity ("PIPE"), net | $ 12 | [1] | 5,542 | 0 | 5,554 | ||
Shares and warrants issuance - Private Investment in Public Equity ("PIPE"), net (in shares) | [1] | 130,435 | |||||
Exercise of warrants | $ 4 | [1] | 1,926 | 0 | 1,930 | ||
Exercise of warrants (in shares) | [1] | 41,967 | |||||
Net loss and comprehensive loss | $ 0 | [1] | 0 | (7,246) | (7,246) | ||
Balance at Dec. 31, 2021 | $ 94 | [1] | 41,715 | (23,727) | 18,082 | ||
Balance (in shares) at Dec. 31, 2021 | [1] | 1,066,544 | |||||
Share-based compensation to employees and directors | $ 0 | [1] | 1,389 | 0 | 1,389 | ||
Share-based compensation to service providers | 0 | [1] | 342 | 0 | 342 | ||
Share issuance to service providers | $ 0 | [1] | 0 | 0 | 0 | ||
Share issuance to service providers (in shares) | [1] | 15,211 | |||||
Net loss and comprehensive loss | $ 0 | [1] | 0 | (8,792) | (8,792) | ||
Balance at Dec. 31, 2022 | $ 94 | [1] | 43,446 | (32,519) | 11,021 | ||
Balance (in shares) at Dec. 31, 2022 | [1] | 1,081,755 | |||||
Share-based compensation to employees and directors | $ 0 | [1] | 804 | 0 | 804 | ||
Exercise of warrants (in shares) | 467,895 | ||||||
Share issuance to service providers | [1],[2] | 0 | 0 | [2] | |||
Share issuance to service providers (in shares) | [1] | 8,697 | |||||
Issuance of common stock and pre-funded warrants upon private placement, net of underwriting commissions and other offering costs. | [3] | $ 39 | [1] | 1,411 | 0 | 1,450 | |
Issuance of common stock and pre-funded warrants upon private placement, net of underwriting commissions and other offering costs.( in shares) | [1],[3] | 467,895 | |||||
Issuance and exercise of common stock warrants upon private placement, net of underwriting commissions and other offering costs. | $ 14 | [1] | 3,294 | 3,308 | [2] | ||
Issuance and exercise of common stock warrants upon private placement, net of underwriting commissions and other offering costs. (in shares) | [1] | 170,000 | |||||
Net loss and comprehensive loss | $ 0 | [1] | 0 | (9,344) | (9,344) | ||
Balance at Dec. 31, 2023 | $ 147 | [1] | $ 48,955 | $ (41,863) | $ 7,239 | ||
Balance (in shares) at Dec. 31, 2023 | [1] | 1,728,347 | |||||
[1]All share amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split (Note 1c).[2]Represents amount less than $1[3]In addition to the issuance of 467,895 shares, an additional amount of 467,895 warrants exercisable into common shares were issued. These warrants were classified as long-term liability and were fully exercised. The investor paid for a full exercise of these warrants and decided that the Company will issue 170,000 shares. The investor has a right to issue an additional 297,895 shares (Note 7c). |
STATEMENTS OF CHANGES IN SHAR_2
STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (Parenthetical) - shares | 1 Months Ended | 12 Months Ended | ||||
Dec. 28, 2023 | Jun. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2021 | [1] | ||
Common Stock [Member] | ||||||
Issuance of common stock and pre-funded warrants upon private placement, net of underwriting commissions and other offering costs.( in shares) | [1],[2] | 467,895 | ||||
Exercise of warrants (in shares) | 467,895 | 41,967 | ||||
Issuance and exercise of common stock warrants upon private placement, net of underwriting commissions and other offering costs. (in shares) | [1] | 170,000 | ||||
Reverse split | 1-for-10 | |||||
Number of additional shares issued | 170,000 | |||||
Investor [Member] | ||||||
Reverse split | a reverse share split of its shares at the ratio of 1-for-10, such that each ten (10) ordinary shares, par value NIS 0.03 per share, were consolidated into one (1) ordinary share, par value NIS 0.30 | |||||
Number of additional shares issued | 297,895 | |||||
[1]All share amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split (Note 1c).[2]In addition to the issuance of 467,895 shares, an additional amount of 467,895 warrants exercisable into common shares were issued. These warrants were classified as long-term liability and were fully exercised. The investor paid for a full exercise of these warrants and decided that the Company will issue 170,000 shares. The investor has a right to issue an additional 297,895 shares (Note 7c). |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities | |||
Net loss | $ (9,344) | $ (8,792) | $ (7,246) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 15 | 15 | 7 |
Exchange rate differences on cash, cash equivalents and restricted cash | (2) | 0 | 0 |
Share-based compensation to employees and directors | 804 | 1,389 | 812 |
Net change in operating lease asset and liability | (9) | 0 | 0 |
Share-based compensation to service providers | 0 | 342 | 412 |
Warrant issuance costs | 368 | 0 | 0 |
Interest income (expenses) | 85 | (85) | 0 |
Change in warrant liability valuation | (1,726) | 0 | 0 |
Loss from inducement offer letter agreement | 1,502 | 0 | 0 |
Changes in operating assets and liabilities: | |||
Prepaid expenses and other current assets | 330 | 356 | (348) |
Trade payables | 12 | 73 | (585) |
Employees, related liabilities and accrued expenses | 1,286 | 243 | 395 |
Net cash used in operating activities | (6,679) | (6,459) | (6,553) |
Cash flows from investing activities | |||
Purchase of property and equipment | (9) | (6) | (50) |
Proceeds from short term deposits | 7,000 | ||
Purchase of short-term deposit | (1,000) | (6,000) | 0 |
Net cash provided by (used in) investing activities | 5,991 | (6,006) | (50) |
Cash flows from financing activities | |||
Proceeds from exercise/issuance of warrants | 2,511 | 0 | 1,930 |
Proceeds From Inducement Offer Letter Agreement | 1,334 | ||
Issuance costs | (932) | 0 | (446) |
Proceeds from Issuance of shares and pre-funded warrants | 1,703 | ||
Proceeds from issuance of ordinary shares under Private Investment in Public Equity | 0 | 0 | 6,000 |
Net cash provided by financing activities | 4,616 | 0 | 7,484 |
Effect of Exchange rate changes on cash, cash equivalents and restricted cash | 2 | 0 | 0 |
Cash, Cash Equivalents, Restricted Cash, and Restricted Cash Equivalents, Period Increase (Decrease), Including Exchange Rate Effect, Total | 3,930 | (12,465) | 881 |
Cash, cash equivalents and restricted cash at the beginning of the year | 4,106 | 16,571 | 15,690 |
Cash, cash equivalents and restricted cash at the end of the year | 8,036 | 4,106 | 16,571 |
Supplemental cash flow information: | |||
Cash and cash equivalents | 8,026 | 4,096 | 16,537 |
Restricted cash | 10 | 10 | 34 |
Total cash, cash equivalents, and restricted cash | 8,036 | 4,106 | 16,571 |
Acquisition of right-of-use assets by means of lease liabilities | $ 113 | $ 0 | $ 0 |
GENERAL
GENERAL | 12 Months Ended |
Dec. 31, 2023 | |
Compensation Related Costs [Abstract] | |
GENERAL | NOTE 1:- GENERAL a. PainReform Ltd. (“the Company”) was incorporated and started business operations in November 2007. The Company is a clinical stage specialty pharmaceutical company focused on the reformulation of established therapeutics. The Company’s proprietary extended-release drug-delivery system is designed to provide an extended period of post-surgical pain relief without the need for repeated dose administration while reducing the potential need for the use of opiates. b. Liquidity Since its inception, the Company has devoted substantially all its efforts to research and development, clinical trials, and capital raising activities. The Company is still in its development and clinical stage and has not yet generated revenues. The Company has incurred significant losses and negative cash flows from operations and incurred losses of $9,344, $8,792 and $7,246 for the years ended December 31, 2023, 2022 and 2021, respectively. During the years ended December 31, 2023, 2022 and 2021, the Company had negative operating cash outflows of $6,679, $6,459, and $6,553, respectively. As of December 31, 2023, the Company’s accumulated deficit was $41,863. The Company has funded its operations to date primarily through equity financing and has cash on hand (including restricted cash) of $8,036 as of December 31, 2023. In July 2023, the Company consummated two registered direct offerings of its ordinary shares and simultaneous private placements of warrants to purchase its ordinary shares, resulting in aggregate gross proceeds of $4.2 million and net proceeds of $3.6 million (Note 7c). In December 2023, the Company consummated a warrant exercise transaction. As part of the transaction, the Company agreed to the exercise of outstanding warrants to purchase up to an aggregate of 467,896 ordinary shares, having an exercise price of $9.00 per ordinary share, issued by the Company in July 2023, at a reduced exercise price of $2.85 per ordinary share. The warrant exercise resulted in aggregate gross proceeds of $1.3 million. In addition, the Investor received 935,792 new warrants with an exercise price of $2.85 (Note 7c). The Company expects to continue incurring losses, and negative cash flows from operations until its product, PRF-110, reaches commercial profitability. As a result of the initiation of the Company's Phase III clinical trial in March 2023, along with its current cash position, the Company does not have sufficient resources to fund operations until the end of its phase III study, nor to continue as a going concern for at least one year from the issuance date of these financial statements. Management's plans include continued raising capital through sale of additional equity securities, debt or capital inflows from strategic partnerships. There are no assurances, however, that the Company will successfully obtain the level of financing needed for its operations. If the Company is unsuccessful in raising capital, it may need to reduce activities, curtail, or abandon some or all of its operations, which could materially harm the Company’s business, financial condition and results of operations. These factors raise substantial doubt about the Company’s ability to continue as a going concern. These financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business and do not include any adjustments that might result from the outcome of this uncertainty. c. In June 2023, the Company effected a reverse share split of its shares at the ratio of 1-for-10, such that each ten (10) ordinary shares, par value NIS 0.03 per share, were consolidated into one (1) ordinary share, par value NIS 0.30. As a result of rounding of fractional shares as part of the reverse share split, 18,338 ordinary shares were added, bringing the Company’s total outstanding shares on a post-split basis to 1,090,452. All related share and per share data have been retroactively applied to the financial statements and their related notes for all periods presented. d. In May 2023, the Company announced that its supplier of the active pharmaceutical ingredient, or API, had received a deficiency notice from the FDA related to the supplier’s Drug Master File, or DMF. The DMF is the file on record with the FDA representing the manufacturing process and facility to produce the API. As a result, the second part of the Company’s first Phase 3 trial was delayed and re-commenced once the required information was provided by the supplier to the FDA and the deficiency notice was resolved, which occurred in September 2023. None of the issues raised were related to the Company’s PRF-110 product. Following the FDA review process of the DMF the Company received a notification from the FDA in September 2023 and an official letter in November 2023, allowing the use of the API manufactured by the DMF holder and an approval to proceed with the clinical trial. In October 2023, the Company reactivated the clinical study and enrolled the first patients in the second part of the Phase 3 trial with the Company’s contract research organization, which will include up to 415 patients in the double-blind study multiple clinical sites in the U.S., measuring pain reduction by PRF-110 over 72 hours compared with a placebo and Naropin® (ropivacaine). e. U.S. and global markets are experiencing volatility and disruption following the escalation of geopolitical tensions and the start of the military conflict between Israel and Hamas and the conflict between Russia and Ukraine. Although the length and impact of these ongoing military conflicts is highly unpredictable, they could lead to market disruptions, including significant volatility in commodity prices, credit and capital markets. Additionally, Russia’s prior annexation of Crimea, recent recognition of two separatist republics in the Donetsk and Luhansk regions of Ukraine and subsequent military interventions in Ukraine have led to sanctions and other penalties being levied by the United States, European Union and other countries against Russia, Belarus, the Crimea Region of Ukraine, the so-called Donetsk People’s Republic, and the so-called Luhansk People’s Republic, including agreement to remove certain Russian financial institutions from the Society for Worldwide Interbank Financial Telecommunication (SWIFT) payment system. Additional potential sanctions and penalties have also been proposed and/or threatened. Russian military actions and the resulting sanctions could adversely affect the global economy and financial markets and lead to instability and lack of liquidity in capital markets, potentially making it more difficult for us to obtain additional funds. Any of the abovementioned factors could affect our business, prospects, financial condition, and operating results. The extent and duration of the military action, sanctions and resulting market disruptions are impossible to predict. f. On October 7, 2023, an unprecedented attack was launched against Israel, which thrust Israel into a state of war. The Company is continuing the development of its product and progressing with the clinical trials taking place out of Israel. At this time, the Company's management does not expect this situation to have a material impact on its operations or its business results. g. The Company reports its financial results in U.S. dollars. A portion of research and development and general and administrative expenses of our Israeli operations are incurred in New Israeli Shekel ("NIS"). As a result, the Company is exposed to exchange rate risks that may materially and adversely affect our financial results. If the NIS appreciates against the U.S. dollar, or if the value of the NIS decline against the U.S. dollar, at a time when the rate of inflation in the cost of Israeli goods and services exceed the rate of decline in the relative value of the NIS, then the U.S. dollar-denominated cost of our operations in Israel would increase and our results of operations could be materially and adversely affected. Inflation in Israel compounds the adverse impact of a devaluation of the NIS against the U.S. dollar by further increasing the amount of our Israeli expenses. Israeli inflation may also (in the future) outweigh the positive effect of any appreciation of the U.S. dollar relative to the NIS, if, and to the extent that, it outpaces such appreciation or precedes such appreciation. The Israeli rate of inflation did not have a material adverse effect on our financial condition during 2023 ,2022 and 2021. Given our general lack of currency hedging arrangements to protect us from fluctuations in the exchange rates of the NIS in relation to the U.S. dollar (and/or from inflation of such non-U.S. currencies), the Company may be exposed to material adverse effects from such movements. the Company cannot predict any future trends in the rate of inflation in Israel or the rate of devaluation (if any) of the U.S. dollar against the NIS. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 2:- SIGNIFICANT ACCOUNTING POLICIES a. Basis of presentation: The financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). The significant accounting policies described below have been applied consistently in relation to all the periods presented, unless otherwise stated. b. Use of estimate in preparation of financial statements: The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company evaluates on an ongoing basis its assumptions. Estimates are primarily used for, but not limited to, valuation of share-based compensation, clinical trial accrual expenses, and valuation allowances. The Company’s management believes that the estimates, judgments, and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the financial statements, and the reported amounts of expenses during the reporting periods. Actual results could differ from those estimates. c. Financial statements in United States dollars: The Company’s functional currency is the U.S. dollar (“dollar” or “$”) since the dollar is the currency of the primary economic environment in which the Company has operated and expects to continue to operate in the foreseeable future. Transactions and balances originally denominated in U.S. dollars are presented at their original amounts. Balances in non-U.S. dollar currencies are translated into U.S. dollars using historical and current exchange rates for non-monetary and monetary balances, respectively. For non-U.S. dollar transactions and other items in the statements of income (indicated below), the following exchange rates are used: (i) for transactions - exchange rates at transaction dates or average exchange rates; and (ii) for other items (derived from non-monetary balance sheet items such as depreciation) - historical exchange rates. Currency transaction gains and losses are presented in financial income or expenses, as appropriate. d. Cash and cash equivalents: Cash equivalents are short-term highly liquid investments that are readily convertible to cash with original maturities of three months or less at acquisition. e. Short term deposit: Bank deposits with original maturity dates of more than three months but at balance sheet date are less than one year are included in short-term deposits. The fair value of bank deposits approximates the carrying value since they bear interest at rates close to the prevailing market rates. f. Restricted cash: As of December 31, 2023 and 2022, the Company’s restricted cash consisted of immaterial bank deposits that were denominated in NIS. Restricted deposits are presented at cost including accrued interest. These bank deposits are used as securities for the Company's credit cards. g. Fair Value Measurements: The carrying values of Company’s financial assets and liabilities, including cash and cash equivalents, restricted cash, other current assets, trade payables and other accounts payable approximate their fair value due to the short-term maturity of these instruments. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. Assets and liabilities recorded at fair value in the financial statements are categorized as follows: Level 1 - Observable inputs such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; Level 2 - Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable inputs for similar assets or liabilities. These include quoted prices for identical or similar assets or liabilities in active markets and quoted prices for identical or similar assets of liabilities in markets that are not active; Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. As of December 31, 2023, and 2022 no assets or liabilities are measured at their fair value. h. Property and equipment, net: Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets at the following rates: % Computers, software and electronic equipment 33 Furniture and office equipment 7 i. Research and development expenses: Research and development costs include costs of payroll and related expenses of employees, subcontractors and consultants and other costs related to the Company's operation of its planned clinical trials. Research and development expenses are charged to the statements of comprehensive loss as incurred. Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. The Company outsources its clinical trial activities utilizing external entities such as clinical research organizations, independent clinical investigators, and other third-party service providers to assist the Company with the execution of its clinical trials. Clinical trial expenses are charged to research and development expense as incurred. The Company accrues for expenses resulting from obligations under contracts with its clinical research organization (CRO). The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which services are provided. The Company’s objective is to reflect the appropriate trial expense in the financial statements by matching the appropriate expenses with the period in which services and efforts are expended. In the event advance payments are made to a CRO, the payments are recorded as prepaid clinical trial expenses and deferred clinical trial costs, which will be recognized as expenses as services are rendered. j. Employee severance benefits: The Company is required to make severance payments upon dismissal of an Israeli employee or upon termination of employment in certain circumstances. In accordance with the current employment terms with all of its employees (Section 14 of the Israeli Severance Pay Law, 1963) located in Israel, the Company makes regular deposits with certain insurance companies for accounts controlled by each applicable employee in order to secure the employee’s full retirement benefit and severance obligation. The Company is relieved from any severance pay liability with respect to each such employee after it makes the payments on behalf of the employee. The liability accrued in respect of these employees and the amounts funded, as of the respective agreement dates, are not reflected on the Company’s balance sheet, as the amounts funded are not under the control and management of the Company and the pension or severance pay risks have been irrevocably transferred to the applicable insurance companies. The amounts of severance payment expenses were $73, $60 and $58 for the years ended December 31, 2023, 2022 and 2021, respectively. k. Legal and other contingencies: Certain conditions may exist as of the date of the financial statements, which may result in a loss to the Company, but which will only be resolved when one or more future events occur or fail to occur. The Company’s management assesses such contingent liabilities, if any, and such assessment inherently involves an exercise of judgment. In assessing loss contingencies related to legal proceedings that are pending against the Company or unasserted claims that may result in such proceedings, the Company’s management evaluates the perceived merits of any legal proceedings or unasserted claims as well as the perceived merits of the amount of relief sought or expected to be sought. Management applies the guidance in ASC 450-20, “Loss Contingencies” when assessing losses resulting from contingencies. If the assessment of a contingency indicates that it is probable that a material loss has been incurred and the amount of the liability can be reasonable estimated, then the estimated liability is recorded as accrued expenses in the Company’s financial statements. Legal costs incurred in connection with loss contingencies are expensed as incurred. l. Income taxes: The Company accounts for income taxes using the asset and liability method whereby deferred tax asset and liability account balances are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance, if necessary, to reduce deferred tax assets to their estimated realizable value if it is more likely than not that a portion or all the deferred tax assets will not be realized, based on the weight of available positive and negative evidence. As of December 31, 2023, and 2022, the Company had a full valuation allowance on its deferred tax assets. The Company implements a two-step approach to recognize and measure uncertain tax positions. The first step is to evaluate the tax position taken or expected to be taken in a tax return by determining if the weight of available evidence indicates that it is more likely than not that, on an evaluation of the technical merits, the tax position will be sustained on audit, including resolution of any related appeals or litigation processes. The second step is to measure the tax positions as the largest amount that is more than 50% (cumulative basis) likely to be realized upon ultimate settlement. As of December 31, 2023 and 2022, the total gross amount of provision for unrecognized tax positions was $251 and $243, respectively (Note 5f). The Company recognizes interest and penalties, if any, related to unrecognized tax positions in tax expenses and exchange differences in financial expense. m. Concentrations of credit risk: Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents and restricted cash. Cash and cash equivalents and restricted cash are invested in a major bank in Israel and the United States. Management believes that the banks that hold the Company’s cash, cash equivalent and restricted cash are financially sound and, accordingly, minimal credit risk exists with respect to this cash, cash equivalent and restricted cash. n. Dependence on a single supplier risk: The Company relies, and expects to continue to rely, on a single supplier to manufacture supplies and raw materials for its clinical trial. This clinical trial could be adversely affected by a significant interruption in these manufacturing services or the availability of raw materials. o. Derivative warrant liability Financial equity instruments that do not meet the US GAAP criteria for equity classification are classified as a liability at fair value and are adjusted to fair value at each reporting period. Changes in fair value are recognized in the Company’s statements of comprehensive loss in accordance with ASC 815, “Accounting for Derivative Financial Instruments”. p. Basic and diluted loss per share: Basic loss per share is computed on the basis of the net loss for the period divided by the weighted average number of Ordinary Shares and vested Ordinary Shares issuable for little or no further consideration outstanding during the period. Diluted loss per share is based upon the weighted average number of ordinary shares and of potential Ordinary Shares outstanding when dilutive. Potential Ordinary Shares include outstanding stock options, restricted shares and warrants, which are included under the treasury stock method when dilutive. For the years ended December 31, 2023, 2022 and 2021, all outstanding share options, restricted shares, and warrants have been excluded from the calculation of the diluted net loss per share as all such securities are anti-dilutive for all years presented. The loss and the weighted average number of shares used in computing basic and diluted net loss per share is as follows: Year ended December 31, 2023 2022 2021 Numerator: Net loss applicable to shareholders of ordinary shares $ (9,344 ) $ (8,792 ) $ (7,246 ) Denominator: Shares of Ordinary Share and restricted shares used in computing basic and diluted net loss per share (*) 1,308,920 1,081,755 999,562 Net loss per share of ordinary share, basic and diluted $ (7.14 ) $ (8.13 ) $ (7.25 ) (*) All share amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split (Note 1c). q. Share-based compensation: Share-based compensation to employees and consultants is accounted for in accordance with ASC 718, “Compensation - Share Compensation” (“ASC 718”), which requires estimation of the fair value of share-based payment awards on the date of grant. The value of the portion of the award that is ultimately expected to vest is recognized as an expense over the requisite service period using the straight-line method. The Company has elected to recognize forfeitures, as incurred. The Company grants share-equivalents (“Share Based Compensation”) to its employees, officers, directors, and non-employees in consideration for services rendered (Note 7). The Company accounts for Share-Based Compensation awards classified as equity awards using the grant-date fair value method. The fair value at grant-date of the issued equity award is recognized as an expense on a straight-line basis over the requisite service period. The fair value of each share option granted is estimated using the Black-Scholes option pricing model, which requires a number of assumptions, of which the most significant are the expected share price, volatility, and the expected option term. Expected volatility was calculated based on comparable public companies in the same industry. The expected share option term is calculated for share options granted using the “simplified” method when the required conditions are met. The risk-free interest rate is based on the yield from U.S. treasury bonds with an equivalent term. The expected dividend yield assumption is based on the Company’s historical experience and expectation of no future dividend pay outs. The Company has historically not paid cash dividends and has no foreseeable plans to pay cash dividends in the future. The Company elected to recognize Share-Based Compensation cost for awards with only service conditions that have a graded vesting schedule using the straight-line method based on the multiple-option award approach. r. Deferred offering costs The Company capitalizes certain legal and other third-party fees that are directly related to the Company’s in-process equity financings until such financings are consummated. After the consummation of such equity financings, these costs are recorded as a reduction of the respective gross proceeds. Should a planned equity financing be abandoned, terminated, or significantly delayed, the deferred offering costs are written off to operating expenses. As of December 31, 2023 and 2022, there were no deferred offering costs. s. Segment Reporting The Company has one operating and reportable segment. An operating segment is defined as a component that engages in business activities whose operating results are reviewed by the chief operating decision maker, who is the Company’s Chief Executive Officer, for the purpose of assessing performance and allocating resources and for which discrete financial information is available. t. Leases In accordance with Accounting Standards Codification (“ASC”) 842, Leases, the Company determines whether an arrangement is or contains a lease at the inception of the arrangement and whether such a lease is classified as a financing lease or operating lease at the commencement date of the lease. Leases consist real estate property that are classified as operating leases with rental payment linked to the index. The Company recorded right of use (“ROU”) asset and a lease liability of the Company obligation to make the lease payments. The ROU asset and the liability are included in non-current assets, current liabilities and non-current liabilities on the balance sheet. Operating lease ROU and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term, which may include options to extend or terminate the lease, when it is reasonably certain at the commencement date whether the Company will or will not exercise the option to renew or terminate the lease. In previous periods the Company elected the short-term lease recognition exemption for all leases with a term shorter than 12 months period. This means that for those leases, the Company did not recognize ROU assets or lease liabilities but recognizes lease expenses over the lease term on a straight-line basis (Note 6a). u. Recently Issued Accounting Pronouncements Not Yet Adopted In November 2023, the FASB issued ASU No. 2023-07 Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The ASU improves reportable segments disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The ASU also require that a public entity that has a single reportable segment to provide all the disclosures required by the amendments and all existing segment disclosures in Topic 280. The ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company is currently evaluating this guidance to determine the impact it may have on its financial statements related disclosure. |
PREPAID EXPENSES AND OTHER CURR
PREPAID EXPENSES AND OTHER CURRENT ASSETS | 12 Months Ended |
Dec. 31, 2023 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
PREPAID EXPENSES AND OTHER CURRENT ASSETS | NOTE 3:- PREPAID EXPENSES AND OTHER CURRENT ASSETS December 31, 2023 2022 Receivables from governmental authorities $ 45 $ 55 Prepaid expenses 204 310 $ 249 $ 365 |
ACCRUED EXPENSES
ACCRUED EXPENSES | 12 Months Ended |
Dec. 31, 2023 | |
Accrued Liabilities [Abstract] | |
ACCURUED EXPENSES | NOTE 4:- ACCRUED EXPENSES December 31, 2023 2022 Directors’ fees $ 34 $ 33 Manufacturing and trials expenses 1,486 168 Advisors and legal expenses 148 155 $ 1,668 $ 356 |
TAXES ON INCOME
TAXES ON INCOME | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
TAXES ON INCOME | NOTE 5:- TAXES ON INCOME a. Tax rates applicable to the Company: Taxable income of the Company is subject to the Israeli Corporate tax rate which was 23% for the years ended December 31, 2023, 2022 and 2021. b. Net operating loss carry forward: As of December 31, 2023, and 2022, the Company had net operating loss carry forwards for Israeli income tax purposes of approximately $24,774 and $19,695, respectively. Net operating loss carry forwards in Israel may be carried forward indefinitely and offset against future taxable income. c. As of December 31, 2023, the Company had final tax assessments for tax years prior to and including the tax year ended December 31, 2018. d. Deferred income taxes: Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s deferred tax assets are as follows: December 31, 2023 2022 Net operating loss carry forward $ 5,698 $ 4,530 Research and development expenses 1,179 812 Other 48 34 Less: Valuation allowance (6,925 ) (5,376 ) Net deferred tax asset $ - $ - In assessing the realization of deferred tax assets, management considers whether it is more likely than not that all or some portion of the deferred tax assets will not be realized. The ultimate realization of the deferred tax assets is dependent upon the generation of future taxable income during the periods in which temporary differences are deductible and net operating losses are utilized. Based on consideration of these factors, the Company recorded a full valuation allowance on December 31, 2023, and 2022. e. Reconciliation of theoretical tax expenses to actual expenses The primary difference between the statutory tax rate of the Company and the effective rate results virtually from the changes in valuation allowance in respect of carry forward tax losses, share based compensation expenses and research and development expenses due to the uncertainty of the realization of such tax benefits. f. Uncertain tax positions: A reconciliation of the opening and closing amounts of total unrecognized tax benefits is as follows: December 31, 2023 2022 2021 Opening balance $ 243 $ 234 $ 220 Tax positions taken in the current year - - Interest and Exchange rate differences 8 9 14 Closing balance $ 251 $ 243 $ 234 The balance of total unrecognized tax position, which, if recognized, would affect the effective tax rate in the Company’s statements of comprehensive loss. The Company recognizes interest and penalties, if any, related to unrecognized tax positions in tax expenses and exchange differences in income tax expense. The accrued interest and exchange difference related to uncertain tax positions and the expenses recognized during the years ended December 31, 2023, 2022 and 2021 was $ 8, $9, $14 respectively. |
COMMITMENTS
COMMITMENTS | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES | NOTE 6:- COMMITMENTS: a. On July 26, 2021, the Company engaged in a rental agreement for its principal offices at Tel Aviv, Israel for a 12 months period. On August 1, 2022 the Company extended the rental agreement for an additional 12-month period. On August 1, 2023, the Company signed a new lease agreement ("the New lease agreement") for its principal offices for a period of one year, or until July 31, 2024, with additional option on behalf of the Company for a period of one year until July 31, 2025, that the Company’s management expects to be exercised. According to the Company's accounting policy, in regard to the New lease agreement, the Company recognized ROU assets and lease liabilities. The rent of the office is $5 per month, linked to the consumer price index. If the Company exercises its right to extend the lease for the additional year, the rent will increase by 5%. The annual rent expenses in 2023 was $66. Cash paid for amounts included in the measurement of lease liabilities $33. The weighted average remaining lease term is 1.5 years. The weighted average discount rate was 8.5%. b. On November 13, 2020, and December 3, 2020, the Company entered into a Master Clinical Research Organization Agreement (the “First Agreement”) and a Master Clinical Trial Agreement (the “Second Agreement”) with Lotus Clinical Research (“Lotus”) as the Company’s clinical research organization. According to the agreements Lotus will serve as the clinical research organization for the Company’s planned Phase 3 trials of PRF-110, which began in March 2023 and to take place during the years 2023 - 2024. The Company and the CRO negotiated and signed the updated terms of the First Agreement and the Second Agreement and mutually agreed to update the total milestone completion payment to $5.9 million and to update the payment for the actual number of evaluable subjects to $9.9 million, total $15.8. As of December 31, 2023, the Company accounted for the amounts of $1,514 as prepaid clinical trial expense and recognized expenses of $4.1 million and $1.1 million as clinical trials expenses in 2023 and 2022, respectively. |
SHAREHOLDERS' EQUITY
SHAREHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2023 | |
Stockholders' Equity Note [Abstract] | |
SHAREHOLDERS' EQUITY | NOTE 7:- SHAREHOLDERS’ EQUITY a. Ordinary shares: The Ordinary Shares confer upon their holders the right to participate and vote in general shareholder meetings of the Company and to share in the distribution of dividends, if any, declared by the Company, and rights to receive a distribution of assets upon liquidation. b. Share activity: On March 11, 2021, the Company issued to certain institutional investors (the “Purchasers”) 130,345 Ordinary Shares and warrants to purchase up to an aggregate of 65,217 ordinary shares at a combined purchase price of $46.0 per Ordinary Share and accompanying warrant in a Private Investment in Public Equity (“Private placement”) pursuant to a securities purchase agreement. The private placement resulted in gross proceeds of approximately $6,000. The Company received net amount of $5,554 less issuance costs. On July 22, 2021, as a result of an exercise of warrants to purchase 41,967 shares held by one of the Purchasers, the Company received gross proceeds of $1,930. In connection with the private placement, the Company also entered into a Registration Rights Agreement, dated as of March 8, 2021, with the Purchasers (the “Registration Rights Agreement”). Pursuant to the Registration Rights Agreement, the Company filed a registration statement (the “Registration Statement”), with the SEC to register the resale of the ordinary shares and the Ordinary Shares issuable upon exercise of the warrants. The Registration Statement was declared effective on April 9, 2021. The Company paid the placement agents of the private placement a cash placement fee equal to $390 and an expense reimbursement of $40. The Company also issued to the placement agents warrants to purchase 5,217 Ordinary Shares, at an exercise price of $50.6 per ordinary share and a term expiring on March 10, 2026. The Company paid a total of approximately $500 in placement agent fees and other expenses. c. Warrants and warrants units: The following table summarizes the warrants and warrants units outstanding as of December 31, 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 148,106 $67.2(*) December 8, 2024 Warrants to underwriters September 3, 2020 125,000 $100.00 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 December 2023 warrants December 28,2023 935,792 $2.85 December 28,2028 December 2023 warrants December 28,2023 32,753 $3.56 December 28,2028 TOTAL 4,918,762 (*) Each 10 warrants are exercisable into one IPO unit consisting of one share and one IPO warrant with an exercise price of $88.0. (**) Exercise prices amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split (Note 1c). On July 14, 2023, the Company sold to a certain institutional investor (“the investor”) an aggregate of 117,930 ordinary shares in a registered direct offering at a purchase price of $9.00 per share, and pre-funded warrants to purchase up to 183,300 ordinary shares at a purchase price of $8.999, resulting in gross proceeds of approximately $2.7 million. In addition, the Company issued to the investor unregistered warrants to purchase up to an aggregate of 301,230 ordinary shares in a concurrent private placement. On July 18, 2023, the Company sold to the investor an aggregate of 145,000 ordinary shares in a registered direct offering at a purchase price of $9.00 per share, and pre-funded warrants to purchase up to 21,666 ordinary shares at a purchase price of $8.999, resulting in gross proceeds of approximately $1.5 million. In addition, the Company issued to the investor unregistered warrants to purchase up to an aggregate of 166,666 ordinary shares in a concurrent private placement. The Company determined that the ordinary share warrants issued in July 2023 (the “Common Warrants”) were not indexed to the Company’s own ordinary shares and also, the investor possessed a right to receive any additional consideration that investors of common shares may be entitled to upon a fundamental transaction (as defined in the agreement), therefore were precluded from equity classification. The Common Warrants were measured at fair value at inception and in subsequent reporting periods with changes in fair value recognized as financial income or expense as change in fair value of warrant liabilities in the period of change in the condensed statements of comprehensive loss. The Company had recorded the value of the warrants that were issued in the July 2023 transactions as a long-term liability. The Company used the Black-Scholes option pricing model to calculate the valuation with standard deviation of 85.45%, which was based on a share price of $9.00 and a risk-free rate of 4.0%. The valuation of the warrants was $5.48 on July 14, 2023, and $5.17 on July 18, 2023, which resulted in a total valuation of the warrants of $2.5 million as of July 2023. The Company revalued these warrants as of December 28, 2023, prior to the exercise, with standard deviation of 93.49%, which was based on a share price of $3.11 and a risk-free rate of 3.87%. Each warrant valuation was $1.68, which resulted in a total valuation of the warrants of $0.8 million. The change of $1.7 million was recorded as finance income. The contractual term of the warrants was five years. The warrants were fully exercised and the long-term commitment was exercised to the Equity of the Company. On December 28, 2023, the Company entered into an inducement offer letter agreement, or the Inducement Letter, with the investor, of certain of the Company’s existing warrants to purchase up to (i) 301,230 ordinary shares issued on July 14, 2023 at an exercise price of $9.00 per ordinary share, or the July 14 Warrants, and (ii) 166,666 ordinary shares issued on July 18, 2023 at an exercise price of $9.00 per ordinary share, or the July 18 Warrants and together with the July 14, Warrants, the Existing Warrants. Pursuant to the Inducement Letter, the investor agreed to exercise for cash its Existing Warrants to purchase an aggregate of 467,896 ordinary shares at a reduced exercise price of $2.85 per ordinary share, resulting in gross proceeds to the Company of approximately $1.3 million, and net proceeds of approximately $1 million (as of December 31, 2023, $78 were recorded in accrued expenses), in consideration of the Company’s agreement to issue new warrants to purchase American Depositary Shares (“ADS”), or the New Warrants to purchase up to an aggregate of 935,792 ordinary shares at an exercise price of $2.85 per ordinary shares. The valuation of the New Warrants on the grant date was $2.2 million. According to the agreement, the Company recorded a loss of $1.5 million which is included in the financial expenses in the statement of comprehensive loss. As of December 31, 2023 the Company issued 170,000 shares out of the 467,896 shares that the investor paid for, leaving the investor with the right to receive an additional 297,896 shares. In addition, the Company issued 32,753 warrants to the broker with an exercise price of $3.56 per ordinary share. The valuation of the warrants on the grant date was $73. d. Share-based compensation: 1. The 2008 Plan On August 7, 2008, the Board of Directors approved the adoption of the 2008 Share Option Plan (the “2008 Plan”). The 2008 Plan has expired, and no additional grants may be made. 2. The 2019 Plan On July 2, 2019, the Board of Directors approved the adoption of the 2019 Plan. Under the 2019 Plan, the Company may grant its officers, directors, employees and consultants share options of the Company. Each share option granted shall be exercisable at such times and terms and conditions as the Board of Directors may specify in the applicable share option agreement, provided that no share option will be granted with a term in excess of 10 years. Upon the adoption of the 2019 Plan, the Company reserved for issuance 97,148 ordinary shares. On February 23, 2021, the shareholders of the Company approved the grant of options to purchase an aggregate of 30,000 Ordinary Shares to three current board members, the Chairman of the board of directors and to the Chief Technology Officer (who is also a director). Each was granted with options to purchase 6,000 Ordinary Shares of the Company. The options are exercisable to acquire one Ordinary Share of the Company at an exercise price of $45.0 per share. The options vest on a quarterly basis over thirty-six months, so that 1/12 of the options shall vest on the last day of each three-month period, provided that on such date each of the serving directors and Chief Technology Officer, shall serve in such capacity. The options will expire after ten years from their grant date. In April 2022, the Company’s board of directors approved the grant of options to purchase 16,446 Ordinary Shares of the Company to employees. The options were granted under the Company’s 2019 plan. The fair value of share options granted was estimated using the Black Scholes option-pricing model. The options vest over a four-year period, 4/16 of the options shall vest following the lapse of a period of twelve months commencing at the date of grant. The remaining 12/16 of the options shall vest on quarterly basis, so that 1/16 of the options shall vest on the expiry of each quarter. The weighted average grant date fair value per option was $8.90 with an exercise price of $10.60. Modification of share-based compensation On November 23, 2022 (“the commencement date”), the Company’s board of directors approved: (1) the cancellation of certain outstanding options granted to employees in September 2019 (which were fully vested), November 2020, January 2021, May 2021 and April 2022, and the grant of a greater number of replacement options thereof under the new terms with a lower exercise price of US $5.70 and a shorter vesting period (except for September 2019's grant). (2) The grant of 2,127 options to a new employee on the same terms of the replacement options granted to the rest of the Company's employees, as described (the "Modification"). The New Options vest and become exercisable under the following schedule: 50% of the shares covered by the options are immediately vesting on the commencement date determined by the administrator (and in the absence of such determination, the date on which such options were granted), and 6.25% of the shares covered by the options at the end of each subsequent three-month period thereafter over the course of the following three years. The Modification was considered as a Type I modification. The total incremental fair value of these options amounted to $165. An amount of 50% of the incremental fair value were vested immediately at the commencement date and an amount of $83 was recognized immediately, and the remaining incremental fair value will be recognized over the remaining vesting period through December 31, 2024. In addition, the unrecognized compensation cost as of the date of the Modification was recognized over the vesting period of the new options. As a result, an amount of 50% of the unrecognized compensation cost of the cancelled options were vested immediately in the amount of $454, and the remaining unrecognized compensation cost are recognized over the remaining vesting period and until December 31, 2024. As a result of the Modification, (A) 66,764 options were cancelled, comprised of (i) 5,117 options that had been granted in September 2019, at an exercise price of $33.4, (ii) 26,730 options that had been granted in November 2020, at an exercise price of $57.4, (iii) 13,365 options granted in January 2021, at an exercise price of $57.4, and (iv) 5,107 options granted in May 2021, at an exercise price of $30.1, and (ii) 16,446 options that had been granted in April 2022 at an exercise price of $10.6 (the “Cancelled Options”), and (B) 98,877 new options had been granted (including 2,127 option granted to a new employee) (the “New Options”). The intrinsic value of share options outstanding and exercisable as of December 31, 2023 was $2. On June 8, 2023, the Company’s shareholders approved the grant of options to purchase an aggregate of 54,000 shares to two current board members, and to the chairman of the board of directors. Each recipient received a grant of options to purchase 18,000 ordinary shares of the Company, at an exercise price of $5.89 per share. Fifty percent of the options vested upon grant, with the remaining shares vesting on a quarterly basis over three years so that 7,500 Options shall vest on the expiry of each quarter thereafter, provided that on such date each of the serving directors, shall serve in such capacity. The options expire after ten years from their grant date. The Company determined the valuation of the options with these assumptions: average expected term 5.36 years, average risk-free interest rate of 3.85%, volatility of 90.43%, zero dividend yield is expected. The grant-date fair value was $3.20 for each option. The valuation of the option on the grant date was $174. As of December 31, 2023, the Company had 49,720 unvested options. The total unrecognized compensation cost of employee and directors’ options as of December 31, 2023, is $383. The intrinsic value of share options outstanding as of December 31, 2023 was $2 The intrinsic value of share options exercisable as of December 31, 2022 was $9. 3. The following tables summarizes information about options granted to employees and directors: The 2008 Plan Share options outstanding and exercisable to employees and directors under the 2008 Plan are as follows: Number of options Weighted average exercise price Weighted average remaining contractual life USD Options outstanding at beginning of year 15,388 $ 2.40 1.25 Changes during the year: Options granted - - - Options exercised - - - Options forfeited - - - Options outstanding at end of year 15,388 $ 2.40 0.25 Options exercisable at end of year 15,388 $ 2.40 0.25 The 2019 Plan Share options outstanding and exercisable to employees and directors under the 2019 Plan are as follows: Number of options Weighted average exercise price Weighted average remaining contractual life USD Options outstanding at beginning of year 133,994 $ 14.40 9.39 Changes during the year: Options granted 54,000 5.89 9.44 Options cancelled - - - Options exercised - - - Options forfeited - - - Options outstanding at end of year 187,994 $ 11.94 8.69 Options exercisable at end of year 138,274 $ 13.44 8.56 4. The following table sets forth the assumptions that were used in determining the fair value of options granted to employees in 2019 plan for the years ended on December 31, 2023, 2022 and 2021: 2023 2022* 2021* Expected term (years) 5.00-6.41 5.28-6.07 5.86-6.11 Risk-free interest rates 3.82%-3.87 % 2.69%-3.88 % 0.52%-1.13 % Volatility 90.43 % 79.3%-82.6 % 69.67%-78.99 % Dividend yield - - - Exercise price $ 5.89 $ 5.70-10.60 $ 30.13-57.38 * The assumptions presented above are the original assumptions used to determine the options fair value at the date of the grants. The assumptions used to determine the incremental value of the options at the modification date are as presented at the Company's options valuation. The Company recognized $731, $1,104 and $713 during the years ended December 31, 2023, 2022 and 2021, respectively, as share-based compensation expenses which was included in general and administrative expenses, and $73, $285 and $99 during the years ended December 31, 2023, 2022 and 2021, respectively, as share-based compensation expense which was included in research and development expenses. 5. In August 2020, the Company signed a public relation service agreement (the “Service Agreement”) with Crescendo Communications, LLC (“Crescendo”), for a period of two years, commencing immediately after the IPO closing date, and in consideration for 3.75% of the Company's share capital fully diluted Pre-IPO. On August 23, 2020, the Company's Board of Directors approved the Service Agreement with Crescendo and the grant of 15,211 restricted Company's Ordinary Shares ("the first grant"). The Company recognized no expenses during the year ended December 31, 2023 and recognized $275 and $412 during the year ended December 31, 2022, and 2021, respectively, as share-based compensation expenses with respect to the first grant. In April 2022 the foregoing shares were issued. In May 2022, following discussions between the Company and Crescendo regarding the number of shares to which they are entitled, the Company's board of Directors approved the grant of an additional 8,697 of the Company's Ordinary shares, par value NIS 0.3 each to Crescendo ("the second grant"). In February 2023, the Company granted to Crescendo the second grant. During 2022, the Company has recognized $67 as share-based compensation expenses in connection with the second grant, no expense was recognized during the year ended December 31, 2023. |
SELECTED STATEMENTS OF OPERATIO
SELECTED STATEMENTS OF OPERATIONS DATA | 12 Months Ended |
Dec. 31, 2023 | |
Disclosure Text Block Supplement [Abstract] | |
SELECTED STATEMENTS OF OPERATIONS DATA | NOTE 8:- SELECTED STATEMENTS OF OPERATIONS DATA a. Research and development expenses: Year ended December 31, 2023 2022 2021 Subcontractors and consultants $ 1,001 $ 2,228 $ 1,654 Payroll and related expenses 699 766 719 Share-based compensation expense 73 285 99 Clinical trials expenses 4,262 1,121 357 Other expenses - 22 31 $ 6,035 $ 4,422 $ 2,860 b. General and administrative expenses: Year ended December 31, 2023 2022 2021 Professional services $ 1,209 $ 1,489 $ 1,697 Payroll and related expenses 877 780 688 D&O insurance 394 653 935 Rent and office maintenance 191 249 210 Share-based compensation expense 731 1,104 713 Other expenses 147 172 105 $ 3,549 $ 4,447 $ 4,348 c. Other financial income (expenses), net: Year ended December 31, 2023 2022 2021 Interest income 406 160 - Issuance expenses (368 ) - - Bank fees (16 ) (13 ) (10 ) Loss from Inducement offer letter agreement (Note 7c) (1,502 ) - Change in fair value of derivative warrant liability (Note7c) 1,726 - - Exchange rate differences $ 2 (61 ) $ (22 ) Total other financial expenses, net $ 248 86 $ (32 ) |
RELATED PARTIES BALANCES AND TR
RELATED PARTIES BALANCES AND TRANSACTIONS | 12 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions [Abstract] | |
RELATED PARTIES BALANCES AND TRANSACTIONS | NOTE 9:- RELATED PARTIES BALANCES AND TRANSACTIONS a. On January 26, 2020, the Company’s Board of Directors approved a one-time immediate payment of $150 and a payment of $37.5 on a quarterly basis (for such time as the service engagement continues) to the Chairman of the Board of Directors contingent upon shareholder approval, which was granted on July 6, 2020 and successful completion of Company’s IPO which closed on September 3, 2020. b. On February 23, 2021, the shareholders of the Company approved the grant of options to purchase an aggregate of 30,000 Ordinary Shares to three board members, the Chairman of the board of directors and to its Chief Technology Officer (who also serves as a director). c. On June 8, 2023, the Company’s shareholders approved the grant of options to purchase an aggregate of 54,000 shares to two current board members, and to the chairman of the board of directors. The valuation of the option on the grant date was $174. (Note 7d2) Balances with related parties: Year ended December 31, 2023 2022 2021 Employees accrued salaries and bonuses $ 324 $ 359 $ 356 Directors accrued fees expenses 33 33 82 $ 357 $ 392 $ 438 Transactions with related parties: Year ended December 31, 2023 2022 2021 Amounts charged to: Research and development expenses $ 528 $ 702 $ 151 General and administrative expenses $ 1,676 $ 2,091 $ 2,155 |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of presentation | a. Basis of presentation: The financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”). The significant accounting policies described below have been applied consistently in relation to all the periods presented, unless otherwise stated. |
Use of estimate in preparation of financial statements | b. Use of estimate in preparation of financial statements: The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates, judgments and assumptions that affect the amounts reported in the financial statements and accompanying notes. The Company evaluates on an ongoing basis its assumptions. Estimates are primarily used for, but not limited to, valuation of share-based compensation, clinical trial accrual expenses, and valuation allowances. The Company’s management believes that the estimates, judgments, and assumptions used are reasonable based upon information available at the time they are made. These estimates, judgments and assumptions can affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the financial statements, and the reported amounts of expenses during the reporting periods. Actual results could differ from those estimates. |
Financial statements in United States dollars | c. Financial statements in United States dollars: The Company’s functional currency is the U.S. dollar (“dollar” or “$”) since the dollar is the currency of the primary economic environment in which the Company has operated and expects to continue to operate in the foreseeable future. Transactions and balances originally denominated in U.S. dollars are presented at their original amounts. Balances in non-U.S. dollar currencies are translated into U.S. dollars using historical and current exchange rates for non-monetary and monetary balances, respectively. For non-U.S. dollar transactions and other items in the statements of income (indicated below), the following exchange rates are used: (i) for transactions - exchange rates at transaction dates or average exchange rates; and (ii) for other items (derived from non-monetary balance sheet items such as depreciation) - historical exchange rates. Currency transaction gains and losses are presented in financial income or expenses, as appropriate. |
Cash and cash equivalents | d. Cash and cash equivalents: Cash equivalents are short-term highly liquid investments that are readily convertible to cash with original maturities of three months or less at acquisition. |
Short term deposit | e. Short term deposit: Bank deposits with original maturity dates of more than three months but at balance sheet date are less than one year are included in short-term deposits. The fair value of bank deposits approximates the carrying value since they bear interest at rates close to the prevailing market rates. |
Restricted cash | f. Restricted cash: As of December 31, 2023 and 2022, the Company’s restricted cash consisted of immaterial bank deposits that were denominated in NIS. Restricted deposits are presented at cost including accrued interest. These bank deposits are used as securities for the Company's credit cards. |
Fair Value Measurements | g. Fair Value Measurements: The carrying values of Company’s financial assets and liabilities, including cash and cash equivalents, restricted cash, other current assets, trade payables and other accounts payable approximate their fair value due to the short-term maturity of these instruments. Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability (an exit price) in an orderly transaction between market participants at the reporting date. Assets and liabilities recorded at fair value in the financial statements are categorized as follows: Level 1 - Observable inputs such as unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; Level 2 - Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable inputs for similar assets or liabilities. These include quoted prices for identical or similar assets or liabilities in active markets and quoted prices for identical or similar assets of liabilities in markets that are not active; Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. As of December 31, 2023, and 2022 no assets or liabilities are measured at their fair value. |
Property and equipment, net | h. Property and equipment, net: Property and equipment are stated at cost, net of accumulated depreciation. Depreciation is calculated using the straight-line method over the estimated useful lives of the assets at the following rates: % Computers, software and electronic equipment 33 Furniture and office equipment 7 |
Research and development expenses | i. Research and development expenses: Research and development costs include costs of payroll and related expenses of employees, subcontractors and consultants and other costs related to the Company's operation of its planned clinical trials. Research and development expenses are charged to the statements of comprehensive loss as incurred. Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. The Company outsources its clinical trial activities utilizing external entities such as clinical research organizations, independent clinical investigators, and other third-party service providers to assist the Company with the execution of its clinical trials. Clinical trial expenses are charged to research and development expense as incurred. The Company accrues for expenses resulting from obligations under contracts with its clinical research organization (CRO). The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which services are provided. The Company’s objective is to reflect the appropriate trial expense in the financial statements by matching the appropriate expenses with the period in which services and efforts are expended. In the event advance payments are made to a CRO, the payments are recorded as prepaid clinical trial expenses and deferred clinical trial costs, which will be recognized as expenses as services are rendered. |
Employee severance benefits | j. Employee severance benefits: The Company is required to make severance payments upon dismissal of an Israeli employee or upon termination of employment in certain circumstances. In accordance with the current employment terms with all of its employees (Section 14 of the Israeli Severance Pay Law, 1963) located in Israel, the Company makes regular deposits with certain insurance companies for accounts controlled by each applicable employee in order to secure the employee’s full retirement benefit and severance obligation. The Company is relieved from any severance pay liability with respect to each such employee after it makes the payments on behalf of the employee. The liability accrued in respect of these employees and the amounts funded, as of the respective agreement dates, are not reflected on the Company’s balance sheet, as the amounts funded are not under the control and management of the Company and the pension or severance pay risks have been irrevocably transferred to the applicable insurance companies. The amounts of severance payment expenses were $73, $60 and $58 for the years ended December 31, 2023, 2022 and 2021, respectively. |
Legal and other contingencies | k. Legal and other contingencies: Certain conditions may exist as of the date of the financial statements, which may result in a loss to the Company, but which will only be resolved when one or more future events occur or fail to occur. The Company’s management assesses such contingent liabilities, if any, and such assessment inherently involves an exercise of judgment. In assessing loss contingencies related to legal proceedings that are pending against the Company or unasserted claims that may result in such proceedings, the Company’s management evaluates the perceived merits of any legal proceedings or unasserted claims as well as the perceived merits of the amount of relief sought or expected to be sought. Management applies the guidance in ASC 450-20, “Loss Contingencies” when assessing losses resulting from contingencies. If the assessment of a contingency indicates that it is probable that a material loss has been incurred and the amount of the liability can be reasonable estimated, then the estimated liability is recorded as accrued expenses in the Company’s financial statements. Legal costs incurred in connection with loss contingencies are expensed as incurred. |
Income taxes | l. Income taxes: The Company accounts for income taxes using the asset and liability method whereby deferred tax asset and liability account balances are determined based on differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The Company provides a valuation allowance, if necessary, to reduce deferred tax assets to their estimated realizable value if it is more likely than not that a portion or all the deferred tax assets will not be realized, based on the weight of available positive and negative evidence. As of December 31, 2023, and 2022, the Company had a full valuation allowance on its deferred tax assets. The Company implements a two-step approach to recognize and measure uncertain tax positions. The first step is to evaluate the tax position taken or expected to be taken in a tax return by determining if the weight of available evidence indicates that it is more likely than not that, on an evaluation of the technical merits, the tax position will be sustained on audit, including resolution of any related appeals or litigation processes. The second step is to measure the tax positions as the largest amount that is more than 50% (cumulative basis) likely to be realized upon ultimate settlement. As of December 31, 2023 and 2022, the total gross amount of provision for unrecognized tax positions was $251 and $243, respectively (Note 5f). The Company recognizes interest and penalties, if any, related to unrecognized tax positions in tax expenses and exchange differences in financial expense. |
Concentrations of credit risk | m. Concentrations of credit risk: Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents and restricted cash. Cash and cash equivalents and restricted cash are invested in a major bank in Israel and the United States. Management believes that the banks that hold the Company’s cash, cash equivalent and restricted cash are financially sound and, accordingly, minimal credit risk exists with respect to this cash, cash equivalent and restricted cash. |
Dependence on a single supplier risk | n. Dependence on a single supplier risk: The Company relies, and expects to continue to rely, on a single supplier to manufacture supplies and raw materials for its clinical trial. This clinical trial could be adversely affected by a significant interruption in these manufacturing services or the availability of raw materials. |
Derivative warrant liability | o. Derivative warrant liability Financial equity instruments that do not meet the US GAAP criteria for equity classification are classified as a liability at fair value and are adjusted to fair value at each reporting period. Changes in fair value are recognized in the Company’s statements of comprehensive loss in accordance with ASC 815, “Accounting for Derivative Financial Instruments”. |
Basic and diluted loss per share | p. Basic and diluted loss per share: Basic loss per share is computed on the basis of the net loss for the period divided by the weighted average number of Ordinary Shares and vested Ordinary Shares issuable for little or no further consideration outstanding during the period. Diluted loss per share is based upon the weighted average number of ordinary shares and of potential Ordinary Shares outstanding when dilutive. Potential Ordinary Shares include outstanding stock options, restricted shares and warrants, which are included under the treasury stock method when dilutive. For the years ended December 31, 2023, 2022 and 2021, all outstanding share options, restricted shares, and warrants have been excluded from the calculation of the diluted net loss per share as all such securities are anti-dilutive for all years presented. The loss and the weighted average number of shares used in computing basic and diluted net loss per share is as follows: Year ended December 31, 2023 2022 2021 Numerator: Net loss applicable to shareholders of ordinary shares $ (9,344 ) $ (8,792 ) $ (7,246 ) Denominator: Shares of Ordinary Share and restricted shares used in computing basic and diluted net loss per share (*) 1,308,920 1,081,755 999,562 Net loss per share of ordinary share, basic and diluted $ (7.14 ) $ (8.13 ) $ (7.25 ) (*) All share amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split (Note 1c). |
Share-based compensation | q. Share-based compensation: Share-based compensation to employees and consultants is accounted for in accordance with ASC 718, “Compensation - Share Compensation” (“ASC 718”), which requires estimation of the fair value of share-based payment awards on the date of grant. The value of the portion of the award that is ultimately expected to vest is recognized as an expense over the requisite service period using the straight-line method. The Company has elected to recognize forfeitures, as incurred. The Company grants share-equivalents (“Share Based Compensation”) to its employees, officers, directors, and non-employees in consideration for services rendered (Note 7). The Company accounts for Share-Based Compensation awards classified as equity awards using the grant-date fair value method. The fair value at grant-date of the issued equity award is recognized as an expense on a straight-line basis over the requisite service period. The fair value of each share option granted is estimated using the Black-Scholes option pricing model, which requires a number of assumptions, of which the most significant are the expected share price, volatility, and the expected option term. Expected volatility was calculated based on comparable public companies in the same industry. The expected share option term is calculated for share options granted using the “simplified” method when the required conditions are met. The risk-free interest rate is based on the yield from U.S. treasury bonds with an equivalent term. The expected dividend yield assumption is based on the Company’s historical experience and expectation of no future dividend pay outs. The Company has historically not paid cash dividends and has no foreseeable plans to pay cash dividends in the future. The Company elected to recognize Share-Based Compensation cost for awards with only service conditions that have a graded vesting schedule using the straight-line method based on the multiple-option award approach. |
Deferred offering costs | r. Deferred offering costs The Company capitalizes certain legal and other third-party fees that are directly related to the Company’s in-process equity financings until such financings are consummated. After the consummation of such equity financings, these costs are recorded as a reduction of the respective gross proceeds. Should a planned equity financing be abandoned, terminated, or significantly delayed, the deferred offering costs are written off to operating expenses. As of December 31, 2023 and 2022, there were no deferred offering costs. |
Segment Reporting | s. Segment Reporting The Company has one operating and reportable segment. An operating segment is defined as a component that engages in business activities whose operating results are reviewed by the chief operating decision maker, who is the Company’s Chief Executive Officer, for the purpose of assessing performance and allocating resources and for which discrete financial information is available. |
Leases | t. Leases In accordance with Accounting Standards Codification (“ASC”) 842, Leases, the Company determines whether an arrangement is or contains a lease at the inception of the arrangement and whether such a lease is classified as a financing lease or operating lease at the commencement date of the lease. Leases consist real estate property that are classified as operating leases with rental payment linked to the index. The Company recorded right of use (“ROU”) asset and a lease liability of the Company obligation to make the lease payments. The ROU asset and the liability are included in non-current assets, current liabilities and non-current liabilities on the balance sheet. Operating lease ROU and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term, which may include options to extend or terminate the lease, when it is reasonably certain at the commencement date whether the Company will or will not exercise the option to renew or terminate the lease. In previous periods the Company elected the short-term lease recognition exemption for all leases with a term shorter than 12 months period. This means that for those leases, the Company did not recognize ROU assets or lease liabilities but recognizes lease expenses over the lease term on a straight-line basis (Note 6a). |
Recently Issued Accounting Pronouncements Not Yet Adopted | u. Recently Issued Accounting Pronouncements Not Yet Adopted In November 2023, the FASB issued ASU No. 2023-07 Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures. The ASU improves reportable segments disclosure requirements, primarily through enhanced disclosures about significant segment expenses. The ASU also require that a public entity that has a single reportable segment to provide all the disclosures required by the amendments and all existing segment disclosures in Topic 280. The ASU is effective for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. The Company is currently evaluating this guidance to determine the impact it may have on its financial statements related disclosure. |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of depreciation rates for property and equipment | % Computers, software and electronic equipment 33 Furniture and office equipment 7 |
Schedule of computation of basic and diluted losses per share | Year ended December 31, 2023 2022 2021 Numerator: Net loss applicable to shareholders of ordinary shares $ (9,344 ) $ (8,792 ) $ (7,246 ) Denominator: Shares of Ordinary Share and restricted shares used in computing basic and diluted net loss per share (*) 1,308,920 1,081,755 999,562 Net loss per share of ordinary share, basic and diluted $ (7.14 ) $ (8.13 ) $ (7.25 ) (*) All share amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split (Note 1c). |
PREPAID EXPENSES AND OTHER CU_2
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | |
Schedule of prepaid expenses and other current assets | December 31, 2023 2022 Receivables from governmental authorities $ 45 $ 55 Prepaid expenses 204 310 $ 249 $ 365 |
ACCRUED EXPENSES (Tables)
ACCRUED EXPENSES (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Accrued Liabilities [Abstract] | |
Schedule of accrued expenses | December 31, 2023 2022 Directors’ fees $ 34 $ 33 Manufacturing and trials expenses 1,486 168 Advisors and legal expenses 148 155 $ 1,668 $ 356 |
TAXES ON INCOME (Tables)
TAXES ON INCOME (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Schedule of deferred income taxes | December 31, 2023 2022 Net operating loss carry forward $ 5,698 $ 4,530 Research and development expenses 1,179 812 Other 48 34 Less: Valuation allowance (6,925 ) (5,376 ) Net deferred tax asset $ - $ - |
Schedule of unrecognized tax benefits | December 31, 2023 2022 2021 Opening balance $ 243 $ 234 $ 220 Tax positions taken in the current year - - Interest and Exchange rate differences 8 9 14 Closing balance $ 251 $ 243 $ 234 |
SHAREHOLDERS' EQUITY (Tables)
SHAREHOLDERS' EQUITY (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of warrants and warrants units outstanding | c. Warrants and warrants units: The following table summarizes the warrants and warrants units outstanding as of December 31, 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 148,106 $67.2(*) December 8, 2024 Warrants to underwriters September 3, 2020 125,000 $100.00 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 December 2023 warrants December 28,2023 935,792 $2.85 December 28,2028 December 2023 warrants December 28,2023 32,753 $3.56 December 28,2028 TOTAL 4,918,762 (*) Each 10 warrants are exercisable into one IPO unit consisting of one share and one IPO warrant with an exercise price of $88.0. (**) Exercise prices amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split (Note 1c). |
Schedule of Black-Scholes to estimate fair value | 2023 2022* 2021* Expected term (years) 5.00-6.41 5.28-6.07 5.86-6.11 Risk-free interest rates 3.82%-3.87 % 2.69%-3.88 % 0.52%-1.13 % Volatility 90.43 % 79.3%-82.6 % 69.67%-78.99 % Dividend yield - - - Exercise price $ 5.89 $ 5.70-10.60 $ 30.13-57.38 |
2008 Plan [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of options granted to employees | Number of options Weighted average exercise price Weighted average remaining contractual life USD Options outstanding at beginning of year 15,388 $ 2.40 1.25 Changes during the year: Options granted - - - Options exercised - - - Options forfeited - - - Options outstanding at end of year 15,388 $ 2.40 0.25 Options exercisable at end of year 15,388 $ 2.40 0.25 |
2019 Plan [Member] | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Schedule of options granted to employees | Number of options Weighted average exercise price Weighted average remaining contractual life USD Options outstanding at beginning of year 133,994 $ 14.40 9.39 Changes during the year: Options granted 54,000 5.89 9.44 Options cancelled - - - Options exercised - - - Options forfeited - - - Options outstanding at end of year 187,994 $ 11.94 8.69 Options exercisable at end of year 138,274 $ 13.44 8.56 |
SELECTED STATEMENTS OF OPERAT_2
SELECTED STATEMENTS OF OPERATIONS DATA (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Disclosure Text Block Supplement [Abstract] | |
Schedule of research and development expenses | Year ended December 31, 2023 2022 2021 Subcontractors and consultants $ 1,001 $ 2,228 $ 1,654 Payroll and related expenses 699 766 719 Share-based compensation expense 73 285 99 Clinical trials expenses 4,262 1,121 357 Other expenses - 22 31 $ 6,035 $ 4,422 $ 2,860 |
Schedule of general and administrative expenses | Year ended December 31, 2023 2022 2021 Professional services $ 1,209 $ 1,489 $ 1,697 Payroll and related expenses 877 780 688 D&O insurance 394 653 935 Rent and office maintenance 191 249 210 Share-based compensation expense 731 1,104 713 Other expenses 147 172 105 $ 3,549 $ 4,447 $ 4,348 |
Schedule of financial expenses net | Year ended December 31, 2023 2022 2021 Interest income 406 160 - Issuance expenses (368 ) - - Bank fees (16 ) (13 ) (10 ) Loss from Inducement offer letter agreement (Note 7c) (1,502 ) - Change in fair value of derivative warrant liability (Note7c) 1,726 - - Exchange rate differences $ 2 (61 ) $ (22 ) Total other financial expenses, net $ 248 86 $ (32 ) |
RELATED PARTIES BALANCES AND _2
RELATED PARTIES BALANCES AND TRANSACTIONS (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions [Abstract] | |
Schedule of balances and transactions with related parties | Balances with related parties: Year ended December 31, 2023 2022 2021 Employees accrued salaries and bonuses $ 324 $ 359 $ 356 Directors accrued fees expenses 33 33 82 $ 357 $ 392 $ 438 Transactions with related parties: Year ended December 31, 2023 2022 2021 Amounts charged to: Research and development expenses $ 528 $ 702 $ 151 General and administrative expenses $ 1,676 $ 2,091 $ 2,155 |
GENERAL (Narrative) (Details)
GENERAL (Narrative) (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||||||||
Jul. 14, 2023 $ / shares shares | Mar. 11, 2021 shares | Dec. 28, 2023 USD ($) $ / shares shares | Jul. 31, 2023 USD ($) $ / shares | Jul. 18, 2023 $ / shares shares | Jun. 30, 2023 shares | Jul. 22, 2021 USD ($) shares | Dec. 31, 2023 USD ($) shares | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2023 ₪ / shares | Dec. 31, 2023 USD ($) $ / shares shares | |
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Net loss | $ | $ (9,344) | $ (8,792) | $ (7,246) | |||||||||
Cash used in operating activities | $ | (6,679) | (6,459) | (6,553) | |||||||||
Accumulated deficit | $ | (32,519) | $ (41,863) | ||||||||||
Cash | $ | $ 8,036 | |||||||||||
Gross proceeds from issuance of warrants | $ | 1,300 | |||||||||||
Proceeds from exercise/issuance of warrants | $ | $ 1,300 | $ 1,930 | $ 2,511 | $ 0 | $ 1,930 | |||||||
Warrants Issued to purchase aggregate ordinary shares | shares | 467,896 | 467,896 | ||||||||||
Number of warrants | shares | 41,967 | 4,918,762 | ||||||||||
Warrants exercise price | (per share) | $ 9 | $ 2.85 | $ 2.85 | $ 9 | ₪ 9 | $ 50.6 | ||||||
Reverse split | 1-for-10 | |||||||||||
Reverse share split, stock issued | shares | 18,338 | |||||||||||
Outstanding shares on a post-split basis | shares | 1,090,452 | |||||||||||
Investor [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Warrants Issued to purchase aggregate ordinary shares | shares | 183,300 | 21,666 | ||||||||||
Number of warrants | shares | 117,930 | 145,000 | 935,792 | |||||||||
Warrants exercise price | $ / shares | $ 2.85 | |||||||||||
Reverse split | a reverse share split of its shares at the ratio of 1-for-10, such that each ten (10) ordinary shares, par value NIS 0.03 per share, were consolidated into one (1) ordinary share, par value NIS 0.30 | |||||||||||
Private Placement [Member] | ||||||||||||
Subsidiary, Sale of Stock [Line Items] | ||||||||||||
Gross proceeds from issuance of warrants | $ | $ 4,200 | |||||||||||
Proceeds from exercise/issuance of warrants | $ | $ 3,600 | |||||||||||
Warrants Issued to purchase aggregate ordinary shares | shares | 65,217 | 5,217 | ||||||||||
Number of warrants | shares | 130,345 |
SIGNIFICANT ACCOUNTING POLICI_4
SIGNIFICANT ACCOUNTING POLICIES (Narrative) (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Accounting Policies [Abstract] | ||||
Unrecognized tax | $ 251 | $ 243 | $ 234 | $ 220 |
SIGNIFICANT ACCOUNTING POLICI_5
SIGNIFICANT ACCOUNTING POLICIES (Schedule of Depreciation Rates for Property and Equipment) (Details) | 12 Months Ended |
Dec. 31, 2023 | |
Computers, software and electronic equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Annual depreciation rate | 33% |
Furniture and office equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Annual depreciation rate | 7% |
SIGNIFICANT ACCOUNTING POLICI_6
SIGNIFICANT ACCOUNTING POLICIES (Schedule of Computation of Basic and Diluted Losses Per Share) (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | ||
Numerator: | ||||
Net loss applicable to shareholders of ordinary shares | $ (9,344) | $ (8,792) | $ (7,246) | |
Denominator: | ||||
Shares of Ordinary Share and restricted shares used in computing basic net loss per share | [1] | 1,308,920 | 1,081,755 | 999,562 |
Weighted average number of Ordinary Share used in computing diluted net loss per share | [1] | 1,308,920 | 1,081,755 | 999,562 |
Net loss per share of ordinary share, basic | $ (7.14) | $ (8.13) | $ (7.25) | |
Net loss per share of ordinary share, diluted | $ (7.14) | $ (8.13) | $ (7.25) | |
[1]All share amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split (Note 1c) |
PREPAID EXPENSES AND OTHER CU_3
PREPAID EXPENSES AND OTHER CURRENT ASSETS (Schedule of Prepaid Expenses and Other Current Assets) (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred Costs, Capitalized, Prepaid, and Other Assets Disclosure [Abstract] | ||
Receivables from governmental authorities | $ 45 | $ 55 |
Prepaid expenses | 204 | 310 |
Total prepaid expenses and other current assets | $ 249 | $ 365 |
ACCRUED EXPENSES (Details)
ACCRUED EXPENSES (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Accrued Liabilities [Abstract] | ||
Directors’ fees | $ 34 | $ 33 |
Manufacturing and trials expenses | 1,486 | 168 |
Advisors and legal expenses | 148 | 155 |
ACCURUED EXPENSES | $ 1,668 | $ 356 |
TAXES ON INCOME (Narrative) (De
TAXES ON INCOME (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Tax Credit Carryforward [Line Items] | ||||
Corporate tax rate | 23% | 23% | 23% | |
Provision for unrecognized tax positions | $ 251 | $ 243 | $ 234 | $ 220 |
Interest and Exchange difference | 8 | 9 | $ 14 | |
Israeli [Member] | ||||
Tax Credit Carryforward [Line Items] | ||||
Net operating loss carry forwards | $ 24,774 | $ 19,695 |
TAXES ON INCOME (Schedule of De
TAXES ON INCOME (Schedule of Deferred Income Taxes) (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Deferred tax assets: | ||
Net operating loss carry forward | $ 5,698 | $ 4,530 |
Research and development expenses | 1,179 | 812 |
Other | 48 | 34 |
Less: Valuation allowance | (6,925) | (5,376) |
Net deferred tax asset | $ 0 | $ 0 |
TAXES ON INCOME (Schedule of Un
TAXES ON INCOME (Schedule of Unrecognized Tax Benefits) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||
Opening balance | $ 243 | $ 234 | $ 220 |
Tax positions taken in the current year | 0 | 0 | |
Interest and Exchange rate differences | 8 | 9 | 14 |
Closing balance | $ 251 | $ 243 | $ 234 |
COMMITMENTS (Narrative) (Detail
COMMITMENTS (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | |||||
Aug. 01, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Aug. 01, 2022 | Aug. 01, 2021 | Jul. 26, 2021 | |
Purchase Commitment, Excluding Long-term Commitment [Line Items] | ||||||
Term of contract | 12 months | 12 months | ||||
Rent of office | $ 66 | |||||
Cash paid for rent | $ 33 | |||||
Weighted average remaining lease term | 1 year 6 months | |||||
Weighted average discount rate | 8.50% | |||||
Accumulated payment on clinical research development | $ 15,800 | |||||
Clinical trial expense | $ 4,100 | $ 1,100 | ||||
New Lease Agreement [Member] | ||||||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | ||||||
Term of contract | 1 year | |||||
Option to extend contract | one year until July 31, 2025 | |||||
Consumer Price Index [Member] | ||||||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | ||||||
Option to extend contract | If the Company exercises its right to extend the lease for the additional year, the rent will increase by 5%. | |||||
Rent of office | $ 5 | |||||
First Agreement [Member] | ||||||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | ||||||
Accumulated payment on clinical research development | $ 5,900 | |||||
Second Agreement [Member] | ||||||
Purchase Commitment, Excluding Long-term Commitment [Line Items] | ||||||
Accumulated payment on clinical research development | 9,900 | |||||
Non refundable payment of clinical research and development. | $ 1,514 |
SHAREHOLDERS' EQUITY (Narrative
SHAREHOLDERS' EQUITY (Narrative) (Details) | 1 Months Ended | 12 Months Ended | |||||||||||||||||||||||
Jul. 14, 2023 USD ($) $ / shares shares | Jun. 08, 2023 USD ($) $ / shares shares | Mar. 11, 2021 USD ($) $ / shares shares | Dec. 28, 2023 USD ($) $ / shares shares | Jul. 31, 2023 USD ($) $ / shares | Jul. 18, 2023 USD ($) $ / shares shares | Nov. 23, 2022 $ / shares shares | May 31, 2022 USD ($) | Apr. 30, 2022 $ / shares shares | Jul. 22, 2021 USD ($) shares | May 31, 2021 $ / shares shares | Feb. 23, 2021 $ / shares shares | Jan. 31, 2021 $ / shares shares | Nov. 30, 2020 $ / shares shares | Sep. 30, 2019 $ / shares shares | Dec. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2023 ₪ / shares | Dec. 31, 2023 USD ($) $ / shares shares | Dec. 31, 2022 ₪ / shares shares | May 31, 2022 ₪ / shares shares | Aug. 31, 2020 shares | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||||||||
Ordinary share issued | 1,728,347 | 1,081,755 | |||||||||||||||||||||||
Warrants exercise price | (per share) | $ 9 | $ 2.85 | $ 2.85 | $ 9 | ₪ 9 | $ 50.6 | |||||||||||||||||||
Warrants issued | $ | $ 301,230,000 | $ 166,666,000 | |||||||||||||||||||||||
Options granted | 18,000 | 30,000 | |||||||||||||||||||||||
Per share price | (per share) | $ 3.11 | $ 45 | ₪ 0.3 | $ 9 | ₪ 0.3 | ||||||||||||||||||||
Share-based compensation expense | $ | $ 73,000 | $ 285,000 | $ 99,000 | ||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Intrinsic Value | $ | $ 2,000 | ||||||||||||||||||||||||
Intrinsic value of share options exercisable | $ | $ 9,000 | ||||||||||||||||||||||||
Warrants Issued to purchase aggregate ordinary shares | 467,896 | 467,896 | |||||||||||||||||||||||
Number of ordinary shares called by warrants | 41,967 | 4,918,762 | |||||||||||||||||||||||
Proceeds from exercise/issuance of warrants | $ | $ 1,300,000 | $ 1,930,000 | $ 2,511,000 | 0 | 1,930,000 | ||||||||||||||||||||
Net proceeds from warrant exercises | $ | $ 1,000,000 | ||||||||||||||||||||||||
Placement agent fees and other expense | $ | 500,000 | ||||||||||||||||||||||||
Private placement fee | $ | 390,000 | ||||||||||||||||||||||||
Reimbursement Expense | $ | 40,000 | ||||||||||||||||||||||||
Number of options approved for grant | 2,127 | ||||||||||||||||||||||||
Vesting period of options | 3 years | ||||||||||||||||||||||||
Lower exercise price | $ / shares | $ 5.7 | ||||||||||||||||||||||||
Incremental Fair Value Of Stock Options | $ | $ 165,000 | ||||||||||||||||||||||||
Percentage of incremental fair value vested | 50% | ||||||||||||||||||||||||
Percentage Of Unrecognized Compensation Cost | 50% | ||||||||||||||||||||||||
Unrecognized compensation cost | $ | $ 454,000 | ||||||||||||||||||||||||
Number of unvested stock options | 49,720 | ||||||||||||||||||||||||
Vested Incremental Fair Value Of Stock Options | $ | $ 7,500,000 | $ 83,000 | |||||||||||||||||||||||
Standard deviation percentage | 93.49% | 85.45% | |||||||||||||||||||||||
Risk free rate | 3.85% | 3.87% | 4% | ||||||||||||||||||||||
Valuation of warrants | $ | $ 73,000 | $ 2,500,000 | $ 800,000 | ||||||||||||||||||||||
New warrants issued | $ | 2,200,000 | ||||||||||||||||||||||||
Number of share issued | 170,000 | ||||||||||||||||||||||||
Additional number of share received | 297,896 | ||||||||||||||||||||||||
Stock options assumptions average expected term | 5 years 4 months 9 days | ||||||||||||||||||||||||
Finance Income | $ | $ 1,700,000 | ||||||||||||||||||||||||
Warrant valuation price per share | $ / shares | $ 5.48 | $ 1.68 | $ 5.17 | ||||||||||||||||||||||
General and Administrative Expense [Member] | |||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||||||||
Share-based compensation expense | $ | 731,000 | 1,104,000 | 713,000 | ||||||||||||||||||||||
Research and Development Expense [Member] | |||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||||||||
Share-based compensation expense | $ | $ 73,000 | $ 285,000 | $ 99,000 | ||||||||||||||||||||||
Chief Executive Officer [Member] | |||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||||||||
Options granted | 6,000 | ||||||||||||||||||||||||
2008 Plan [Member] | |||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||||||||
Term plan | excess of 10 years | ||||||||||||||||||||||||
Options outstanding | 15,388 | 15,388 | |||||||||||||||||||||||
Options granted | 16,446 | 5,107 | 13,365 | 26,730 | 5,117 | 0 | |||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Forfeitures in Period | 0 | ||||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Outstanding, Intrinsic Value | $ | $ 2,000 | ||||||||||||||||||||||||
Weighted average exercise price of options granted | $ / shares | $ 5.89 | $ 10.6 | $ 30.1 | $ 57.4 | $ 57.4 | $ 33.4 | $ 0 | ||||||||||||||||||
Cancelled | 66,764 | ||||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 90.43% | ||||||||||||||||||||||||
2019 Plan [Member] | |||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||||||||
Options outstanding | 187,994 | 133,994 | |||||||||||||||||||||||
Options granted | 54,000 | ||||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Forfeitures in Period | 0 | ||||||||||||||||||||||||
Warrants Issued to purchase aggregate ordinary shares | 54,000 | ||||||||||||||||||||||||
Number of options approved for grant | 16,446 | ||||||||||||||||||||||||
Vesting period of options | 4 years | ||||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Award Vesting Rights | 4/16 of the options shall vest following the lapse of a period of twelve months commencing at the date of grant. The remaining 12/16 of the options shall vest on quarterly basis, so that 1/16 of the options shall vest on the expiry of each quarter. | ||||||||||||||||||||||||
Weighted average grant date fair value per option | $ / shares | $ 8.9 | ||||||||||||||||||||||||
Weighted average exercise price of options granted | $ / shares | $ 10.6 | $ 5.89 | |||||||||||||||||||||||
Percentage Of Unrecognized Compensation Cost | 50% | ||||||||||||||||||||||||
Unrecognized compensation cost | $ | $ 6,250 | ||||||||||||||||||||||||
Number of share issued | 97,148 | ||||||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Volatility Rate | [1] | 90.43% | |||||||||||||||||||||||
2019 Plan [Member] | Minimum [Member] | |||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||||||||
Risk free rate | 3.82% | [1] | 2.69% | 0.52% | |||||||||||||||||||||
Stock options assumptions average expected term | 5 years | [1] | 5 years 3 months 10 days | 5 years 10 months 9 days | |||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 79.30% | 69.67% | |||||||||||||||||||||||
2019 Plan [Member] | Maximum [Member] | |||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||||||||
Risk free rate | 3.87% | [1] | 3.88% | 1.13% | |||||||||||||||||||||
Stock options assumptions average expected term | 6 years 4 months 28 days | [1] | 6 years 25 days | 6 years 1 month 9 days | |||||||||||||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Fair Value Assumptions, Expected Volatility Rate | 82.60% | 78.99% | |||||||||||||||||||||||
IPO [Member] | |||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||||||||
Warrants exercise price | $ / shares | $ 88 | ||||||||||||||||||||||||
Private Placement [Member] | |||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||||||||
Warrants Issued to purchase aggregate ordinary shares | 65,217 | 5,217 | |||||||||||||||||||||||
Number of ordinary shares called by warrants | 130,345 | ||||||||||||||||||||||||
Gross proceeds from issuance of private placement | $ | $ 6,000,000 | ||||||||||||||||||||||||
Proceeds from exercise/issuance of warrants | $ | $ 3,600,000 | ||||||||||||||||||||||||
Proceeds from issuance of private placement | $ | $ 5,554,000 | ||||||||||||||||||||||||
Combined purchase price | $ / shares | $ 46 | ||||||||||||||||||||||||
Employee Stock [Member] | |||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||||||||
Unrecognized compensation cost | $ | $ 383,000 | ||||||||||||||||||||||||
Broker [Member] | |||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||||||||
Warrants exercise price | $ / shares | $ 3.56 | ||||||||||||||||||||||||
Additional number of share received | 32,753 | ||||||||||||||||||||||||
New Option [Member] | 2008 Plan [Member] | |||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||||||||
Options granted | 98,877 | ||||||||||||||||||||||||
New Option [Member] | 2008 Plan [Member] | Employee [Member] | |||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||||||||
Options granted | 2,127 | ||||||||||||||||||||||||
ADS [Member] | |||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||||||||
Warrants exercise price | $ / shares | $ 2.85 | ||||||||||||||||||||||||
Warrants Issued to purchase aggregate ordinary shares | 935,792 | ||||||||||||||||||||||||
Crescendo Communications [Member] | |||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||||||||
Ordinary share issued | 8,697 | ||||||||||||||||||||||||
Per share price | ₪ / shares | ₪ 0.3 | ||||||||||||||||||||||||
Share-based compensation expense | $ | $ 67,000 | ||||||||||||||||||||||||
Crescendo Communications [Member] | Restricted Stock [Member] | |||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||||||||
Ordinary share issued | 15,211 | ||||||||||||||||||||||||
Percentage of shares issued | 3.75% | ||||||||||||||||||||||||
Share-based compensation expense | $ | $ 275,000 | $ 412,000 | |||||||||||||||||||||||
Investor [Member] | |||||||||||||||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||||||||||||||||
Warrants exercise price | $ / shares | $ 2.85 | ||||||||||||||||||||||||
Warrants Issued to purchase aggregate ordinary shares | 183,300 | 21,666 | |||||||||||||||||||||||
Number of ordinary shares called by warrants | 117,930 | 145,000 | 935,792 | ||||||||||||||||||||||
Gross proceeds from issuance of private placement | $ | $ 2,700,000 | $ 1,500,000 | |||||||||||||||||||||||
Combined purchase price | $ / shares | $ 8.999 | $ 8.999 | |||||||||||||||||||||||
Number of share issued | 297,895 | ||||||||||||||||||||||||
Issuance of unregistered warrants purchase | $ | $ 301,230,000 | $ 166,666,000 | |||||||||||||||||||||||
[1]The assumptions presented above are the original assumptions used to determine the options fair value at the date of the grants. The assumptions used to determine the incremental value of the options at the modification date are as presented at the Company's options valuation. |
SHAREHOLDERS' EQUITY (Schedule
SHAREHOLDERS' EQUITY (Schedule of Warrants and Warrants Units Outstanding) (Details) | 12 Months Ended | |||||||
Dec. 31, 2023 ₪ / shares shares | Dec. 31, 2023 $ / shares shares | Dec. 28, 2023 $ / shares | Jul. 31, 2023 $ / shares | Jul. 18, 2023 $ / shares | Jul. 14, 2023 $ / shares | Jul. 22, 2021 shares | ||
Class of Warrant or Right [Line Items] | ||||||||
Number of warrants | 4,918,762 | 4,918,762 | 41,967 | |||||
Exercise price | (per share) | ₪ 9 | $ 50.6 | $ 2.85 | $ 2.85 | $ 9 | $ 9 | ||
August 2019 warrants [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Issuance Date | Aug. 22, 2019 | |||||||
Number of warrants | 205,268 | 205,268 | ||||||
Exercise price | $ / shares | [1] | $ 67.2 | ||||||
Exercisable through | Aug. 22, 2024 | |||||||
December 2019 warrants [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Issuance Date | Dec. 09, 2019 | |||||||
Number of warrants | 148,106 | 148,106 | ||||||
Exercise price | $ / shares | [1] | $ 67.2 | ||||||
Exercisable through | Dec. 08, 2024 | |||||||
Warrants to underwriters [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Issuance Date | Sep. 03, 2020 | |||||||
Number of warrants | 125,000 | 125,000 | ||||||
Exercise price | $ / shares | $ 100 | |||||||
Exercisable through | Sep. 01, 2025 | |||||||
Warrants To Underwriters [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Issuance Date | Oct. 05, 2020 | |||||||
Number of warrants | 375,000 | 375,000 | ||||||
Exercise price | $ / shares | $ 88 | |||||||
Exercisable through | Sep. 03, 2025 | |||||||
IPO warrants [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Issuance Date | Sep. 03, 2020 | |||||||
Number of warrants | 2,812,170 | 2,812,170 | ||||||
Exercise price | $ / shares | $ 88 | |||||||
Exercisable through | Sep. 03, 2025 | |||||||
PIPE warrants [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Issuance Date | Mar. 11, 2021 | |||||||
Number of warrants | 232,500 | 232,500 | ||||||
Exercise price | $ / shares | $ 46 | |||||||
Exercisable through | Sep. 10, 2026 | |||||||
Warrants to PIPE placement agent [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Issuance Date | Mar. 11, 2021 | |||||||
Number of warrants | 52,173 | 52,173 | ||||||
Exercise price | $ / shares | $ 50.6 | |||||||
Exercisable through | Mar. 08, 2026 | |||||||
December 2023 warrants [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Issuance Date | Dec. 28, 2023 | |||||||
Number of warrants | 935,792 | 935,792 | ||||||
Exercise price | $ / shares | $ 2.85 | |||||||
Exercisable through | Dec. 28, 2028 | |||||||
December 2023 warrants [Member] | ||||||||
Class of Warrant or Right [Line Items] | ||||||||
Issuance Date | Dec. 28, 2023 | |||||||
Number of warrants | 32,753 | 32,753 | ||||||
Exercise price | $ / shares | $ 3.56 | |||||||
Exercisable through | Dec. 28, 2028 | |||||||
[1]Each warrant is exercisable into one IPO unit consisting of one share and one IPO warrant with an exercise price of $8.80. |
SHAREHOLDERS' EQUITY (Schedul_2
SHAREHOLDERS' EQUITY (Schedule of share options outstanding and exercisable under 2008 Plan) (Details) - $ / shares | 1 Months Ended | 12 Months Ended | |||||||
Jun. 08, 2023 | Apr. 30, 2022 | May 31, 2021 | Feb. 23, 2021 | Jan. 31, 2021 | Nov. 30, 2020 | Sep. 30, 2019 | Dec. 31, 2023 | Dec. 31, 2022 | |
Number of options | |||||||||
Granted | 18,000 | 30,000 | |||||||
2008 Plan [Member] | |||||||||
Number of options | |||||||||
Options outstanding | 15,388 | ||||||||
Granted | 16,446 | 5,107 | 13,365 | 26,730 | 5,117 | 0 | |||
Exercised | 0 | ||||||||
Forfeited | 0 | ||||||||
Options outstanding | 15,388 | 15,388 | |||||||
Exercisable at the end of the year | 15,388 | ||||||||
Weighted-average exercise price | |||||||||
Outstanding at the beginning of the year | $ 2.4 | ||||||||
Granted | $ 5.89 | $ 10.6 | $ 30.1 | $ 57.4 | $ 57.4 | $ 33.4 | 0 | ||
Exercised | 0 | ||||||||
Forfeited | 0 | ||||||||
Outstanding at the end of the year | 2.4 | $ 2.4 | |||||||
Exercisable at the end of the year | $ 2.4 | ||||||||
Weighted-average remaining contractual term | |||||||||
Outstanding at the beginning of the year | 3 months | ||||||||
Granted | 1 year 3 months | ||||||||
Exercisable at the end of the year | 3 months | ||||||||
Plan Twenty Thousand Nineteen [Member] | |||||||||
Number of options | |||||||||
Options outstanding | 133,994 | ||||||||
Granted | 54,000 | ||||||||
Exercised | 0 | ||||||||
Forfeited | 0 | ||||||||
Options outstanding | 187,994 | 133,994 | |||||||
Exercisable at the end of the year | 138,274 | ||||||||
Weighted-average exercise price | |||||||||
Outstanding at the beginning of the year | $ 14.4 | ||||||||
Granted | $ 10.6 | 5.89 | |||||||
Exercised | 0 | ||||||||
Outstanding at the end of the year | 11.94 | $ 14.4 | |||||||
Exercisable at the end of the year | $ 13.44 | ||||||||
Weighted-average remaining contractual term | |||||||||
Outstanding at the beginning of the year | 8 years 6 months 21 days | ||||||||
Granted | 9 years 5 months 8 days | 9 years 4 months 20 days | |||||||
Exercisable at the end of the year | 8 years 8 months 8 days |
SHAREHOLDERS' EQUITY (Schedul_3
SHAREHOLDERS' EQUITY (Schedule of Stock Option Activity) (Details) - $ / shares | 1 Months Ended | 12 Months Ended | |||
Jun. 08, 2023 | Apr. 30, 2022 | Feb. 23, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | |
Number of options | |||||
Granted | 18,000 | 30,000 | |||
2019 Plan [Member] | |||||
Number of options | |||||
Options outstanding | 133,994 | ||||
Granted | 54,000 | ||||
Forfeited | 0 | ||||
Exercised | 0 | ||||
Options outstanding | 187,994 | 133,994 | |||
Exercisable at the end of the year | 138,274 | ||||
Weighted-average exercise price | |||||
Outstanding at the beginning of the year | $ 14.4 | ||||
Granted | $ 10.6 | 5.89 | |||
Exercised | 0 | ||||
Outstanding at the end of the year | 11.94 | $ 14.4 | |||
Exercisable at the end of the year | $ 13.44 | ||||
Weighted-average remaining contractual term | |||||
Outstanding at the beginning of the year | 8 years 6 months 21 days | ||||
Granted | 9 years 5 months 8 days | 9 years 4 months 20 days | |||
Exercisable at the end of the year | 8 years 8 months 8 days |
SHAREHOLDERS' EQUITY (Schedul_4
SHAREHOLDERS' EQUITY (Schedule of assumptions used for fair value of options) (Details) - $ / shares | 1 Months Ended | 12 Months Ended | |||||
Jun. 08, 2023 | Dec. 28, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Expected life | 5 years 4 months 9 days | ||||||
Risk-free interest rates | 3.85% | 3.87% | 4% | ||||
2019 Plan [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Volatility | [1] | 90.43% | |||||
Dividend yield | [1] | 0% | |||||
Minimum [Member] | 2019 Plan [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Expected life | 5 years | [1] | 5 years 3 months 10 days | 5 years 10 months 9 days | |||
Risk-free interest rates | 3.82% | [1] | 2.69% | 0.52% | |||
Volatility | 79.30% | 69.67% | |||||
Exercise price | $ 5.89 | [1] | $ 5.7 | $ 30.13 | |||
Maximum [Member] | 2019 Plan [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Expected life | 6 years 4 months 28 days | [1] | 6 years 25 days | 6 years 1 month 9 days | |||
Risk-free interest rates | 3.87% | [1] | 3.88% | 1.13% | |||
Volatility | 82.60% | 78.99% | |||||
Exercise price | $ 10.6 | $ 57.38 | |||||
[1]The assumptions presented above are the original assumptions used to determine the options fair value at the date of the grants. The assumptions used to determine the incremental value of the options at the modification date are as presented at the Company's options valuation. |
SELECTED STATEMENTS OF OPERAT_3
SELECTED STATEMENTS OF OPERATIONS DATA (Schedule of Research and Development Expenses) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule Of Financial Expenses Net [Abstract] | |||
Subcontractors and consultants | $ 1,001 | $ 2,228 | $ 1,654 |
Payroll and related expenses | 699 | 766 | 719 |
Share-based compensation expense | 73 | 285 | 99 |
Clinical trials expenses | 4,262 | 1,121 | 357 |
Other expenses | 0 | 22 | 31 |
Total Research and development expenses | $ 6,035 | $ 4,422 | $ 2,860 |
SELECTED STATEMENTS OF OPERAT_4
SELECTED STATEMENTS OF OPERATIONS DATA (Schedule of General and Administrative Expenses) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule Of Financial Expenses Net [Abstract] | |||
Professional services | $ 1,209 | $ 1,489 | $ 1,697 |
Payroll and related expenses | 877 | 780 | 688 |
D&O insurance | 394 | 653 | 935 |
Rent and office maintenance | 191 | 249 | 210 |
Share-based compensation expense | 731 | 1,104 | 713 |
Other expenses | 147 | 172 | 105 |
Total General and administrative expenses | $ 3,549 | $ 4,447 | $ 4,348 |
SELECTED STATEMENTS OF OPERAT_5
SELECTED STATEMENTS OF OPERATIONS DATA (Schedule of Financial Expenses, Net) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Schedule Of Financial Expenses Net [Abstract] | |||
Interest income | $ 406 | $ 160 | $ 0 |
Issuance expenses | (368) | 0 | 0 |
Bank fees | (16) | (13) | (10) |
Loss from inducement offer letter agreement | (1,502) | 0 | |
Change in fair value of derivative warrant liability | 1,726 | 0 | 0 |
Exchange rate differences | 2 | (61) | (22) |
Total financial expenses (income) , net | $ 248 | $ 86 | $ (32) |
RELATED PARTIES BALANCES AND _3
RELATED PARTIES BALANCES AND TRANSACTIONS (Narrative) (Details) - USD ($) | 1 Months Ended | |||
Jun. 08, 2023 | Feb. 23, 2021 | Jan. 26, 2020 | Dec. 31, 2023 | |
Related Party Transaction [Line Items] | ||||
Rental properties | $ 66,000 | |||
Options granted | 18,000 | 30,000 | ||
Valuation of options | $ 2,000 | |||
Two Board Members And Chairman [Member] | ||||
Related Party Transaction [Line Items] | ||||
Options granted | 54,000 | |||
Valuation of options | $ 174,000 | |||
Director [Member] | ||||
Related Party Transaction [Line Items] | ||||
One time payment | $ 150,000 | |||
Board of Directors Chairman [Member] | ||||
Related Party Transaction [Line Items] | ||||
One time payment, quarterly basis | $ 37,500 | |||
Three board members, Chairman of the board of directors and to its Chief Technology Officer [Member] | ||||
Related Party Transaction [Line Items] | ||||
Options granted | 30,000 |
RELATED PARTIES BALANCES AND _4
RELATED PARTIES BALANCES AND TRANSACTIONS ( Schedule of Balances and Transactions with Related Parties ) (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 |
Related Party Transactions [Abstract] | |||
Employees accrued salaries and bonuses | $ 324 | $ 359 | $ 356 |
Directors accrued fees expenses | 33 | 33 | 82 |
Employees and directors expense | $ 357 | $ 392 | $ 438 |
RELATED PARTIES BALANCES AND _5
RELATED PARTIES BALANCES AND TRANSACTIONS (Schedule of Balances and Transactions with Related Parties) (Details1) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Amounts charged to | |||
Research and development expenses | $ 528 | $ 702 | $ 151 |
General and administrative expenses | $ 1,676 | $ 2,091 | $ 2,155 |