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F-2 | |
F-3 | |
F-4 | |
F-5 | |
F-6 - F-12 |
As of June 30, | As of December 31, | |||||||||||
Note | 2024 | 2023 | ||||||||||
Assets | ||||||||||||
Current assets: | ||||||||||||
Cash and cash equivalents | $ | 2,783 | $ | 8,026 | ||||||||
Restricted cash | 10 | 10 | ||||||||||
Prepaid clinical trial expenses and deferred clinical trial costs | - | 1,514 | ||||||||||
Prepaid expenses and other current assets | 199 | 249 | ||||||||||
Total current assets | 2,992 | 9,799 | ||||||||||
Non-current assets | ||||||||||||
Operating lease right of use asset | 4 | 73 | 93 | |||||||||
Property and equipment, net | 42 | 38 | ||||||||||
Total long-term assets | 115 | 131 | ||||||||||
Total assets | $ | 3,107 | $ | 9,930 | ||||||||
Liabilities and shareholders’ equity | ||||||||||||
Current liabilities: | ||||||||||||
Trade payables | $ | 119 | $ | 221 | ||||||||
Employees and related liabilities | 440 | 465 | ||||||||||
Operating lease liability | 4 | 57 | 56 | |||||||||
Accrued expenses | 4,275 | 1,668 | ||||||||||
Total current liabilities | 4,891 | 2,410 | ||||||||||
Non-current liabilities: | ||||||||||||
Operating lease liability | 4 | 2 | 30 | |||||||||
Provision for uncertain tax positions | 255 | 251 | ||||||||||
Total non-current liabilities | 257 | 281 | ||||||||||
Total liabilities | 5,148 | 2,691 | ||||||||||
Commitments (Note 7) | ||||||||||||
Shareholders’ equity: | ||||||||||||
Ordinary shares, NIS 0.3 par value; Authorized: 20,000,000 shares as of June 30, 2024, 5,000,000 as of December 31, 2023; Issued and outstanding: 3,468,243 and 1,728,347 shares as of June 30, 2024, and December 31, 2023, respectively. | 288 | 147 | ||||||||||
Additional paid-in capital | 5a | 52,352 | 48,955 | |||||||||
Accumulated deficit | (54,681 | ) | (41,863 | ) | ||||||||
Total shareholders’ (deficit) equity | (2,041 | ) | 7,239 | |||||||||
Total liabilities and shareholders’ (deficit) equity | $ | 3,107 | $ | 9,930 | ||||||||
F - 2
PAINREFORM LTD.
For the Six Months Ended June, | ||||||||||||
Note | 2024 | 2023 | ||||||||||
Operating expenses: | ||||||||||||
Research and development expenses | $ | (11,407 | ) | $ | (2,700 | ) | ||||||
General and administrative expenses | (1,503 | ) | (1,968 | ) | ||||||||
Operating loss | (12,910 | ) | (4,668 | ) | ||||||||
Financial income, net | 8 | 92 | 179 | |||||||||
Net loss and comprehensive loss | $ | (12,818 | ) | $ | (4,489 | ) | ||||||
Basic and diluted net loss per share | 6 | $ | (3.12 | ) | $ | (4.12 | ) | |||||
Weighted average number of Ordinary shares used in computing basic and diluted net loss per share | 4,114,155 | 1,090,452 | ||||||||||
F - 3
PAINREFORM LTD.
Ordinary shares | Additional paid-in capital | Accumulated deficit | Total shareholders’ (deficit) equity | |||||||||||||||||
Number | Amount | |||||||||||||||||||
Balance as of January 1, 2023 | 1,081,755 | $ | 94 | $ | 43,446 | $ | (32,519 | ) | $ | 11,021 | ||||||||||
Share-based compensation to employees and directors | - | - | 441 | - | 441 | |||||||||||||||
Share issuance to service providers | 8,697 | * | * | |||||||||||||||||
Net loss and comprehensive loss | - | - | - | (4,489 | ) | (4,489 | ) | |||||||||||||
Balance as of June 30, 2023 | 1,090,452 | $ | 94 | $ | 43,887 | $ | (37,008 | ) | $ | 6,973 | ||||||||||
Balance as of January 1, 2024 | 1,728,347 | $ | 147 | $ | 48,955 | $ | (41,863 | ) | $ | 7,239 | ||||||||||
Share-based compensation to employees and directors | - | - | 198 | - | 198 | |||||||||||||||
Share issuance (Note 5a) | 297,896 | 24 | (24 | ) | - | - | ||||||||||||||
Issuance of common stock, warrants and prefunded warrants upon private placement, net of underwriting commissions and other offering costs (Note 5c) | 447,500 | 36 | 3,304 | 3,340 | ||||||||||||||||
Exercise of prefunded warrants (Note 5c) | 994,500 | 81 | (81 | ) | - | - | ||||||||||||||
Net loss and comprehensive loss | - | - | (12,818 | ) | (12,818 | ) | ||||||||||||||
Balance as of June 30, 2024 | 3,468,243 | $ | 288 | $ | 52,352 | $ | (54,681 | ) | $ | (2,041 | ) | |||||||||
F - 4
PAINREFORM LTD.
For the Six Months Ended June, | ||||||||
2024 | 2023 | |||||||
Cash flows from operating activities | ||||||||
Net loss | $ | (12,818 | ) | $ | (4,489 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation | 8 | 6 | ||||||
Exchange rate differences on cash, cash equivalents and restricted cash | (3 | ) | 3 | |||||
Net change in operating lease asset and liability | (7 | ) | - | |||||
Share-based compensation to employees and directors | 198 | 441 | ||||||
Interest income | - | 71 | ||||||
Change in: | ||||||||
Other current assets | 1,564 | (23 | ) | |||||
Trade payables | (102 | ) | (139 | ) | ||||
Other accounts payable | 2,516 | 175 | ||||||
Net cash used in operating activities | (8,644 | ) | (3,955 | ) | ||||
Cash flows from investing activities | ||||||||
Purchase of property and equipment | (12 | ) | - | |||||
Purchase of short term deposit | - | (1,000 | ) | |||||
Proceeds from short term deposit | - | 6,000 | ||||||
Net cash provided by (used in) investing activities | (12 | ) | 5,000 | |||||
Cash flows from financing activities | ||||||||
Proceeds from issuance of shares and prefunded warrants | 4,000 | - | ||||||
Issuance costs | (590 | ) | - | |||||
Net cash provided by financing activities | 3,410 | - | ||||||
Effect of Exchange rate changes on cash, cash equivalents and restricted cash | 3 | (3 | ) | |||||
Change in cash, cash equivalents and restricted cash | (5,243 | ) | 1,042 | |||||
Cash, cash equivalents and restricted cash at the beginning of the period | 8,036 | 4,106 | ||||||
Cash, cash equivalents and restricted cash at the end of the period | $ | 2,793 | $ | 5,148 | ||||
As of June, | ||||||||
2024 | 2023 | |||||||
Cash and cash equivalents | $ | 2,783 | $ | 5,138 | ||||
Restricted cash | 10 | 10 | ||||||
Total cash, cash equivalents and restricted cash | $ | 2,793 | $ | 5,148 | ||||
Financial activities not involving cash flow:
Issuance costs | $ | 70 | $ | - |
F - 5
PAINREFORM LTD.
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 $12,818 and $4,489 for the six-month periods ended June 30, 2024, and 2023, respectively. During the six months ended June 30, 2024, and 2023, the Company had operating cash outflows of $8,644, and $3,955, respectively. As of June 30, 2024 the company has a deficit of $1,899 in working capital. The Company expects to continue to incur losses and negative cash flows from operations until its products reach profitability, if at all. As of June 30, 2024, the Company’s accumulated deficit was $54,681. The Company has funded its operations to date primarily through equity financing and has cash on hand (including restricted cash) in the amount of $2,793 as of June 30, 2024. The Company expects to continue incurring losses and negative cash flows from operations until its product, PRF-110, reaches commercial profitability, if at all. As a result of the initiation of the Company’s’ Phase III clinical trial, 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 capital raising through the 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 or 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 does not include any adjustments that might result from the outcome of this uncertainty. |
| c. | The Company reports its financial results in U.S. dollars. A portion of research, development, general and administrative expenses of its 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 its financial results. If the NIS appreciates against the U.S. dollar, or if the value of the NIS declines against the U.S. dollar at a time when the rate of inflation in the cost of Israeli goods and services exceeds the rate of decline in the relative value of the NIS, then the U.S. dollar-denominated cost of its operations in Israel would increase and its 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 its 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 or precedes such appreciation. The Israeli rate of inflation did not have a material adverse effect on its financial condition during the Six months ended June 30, 2024 and 2023, respectively. Given its general lack of currency hedging arrangements to protect it 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. |
d. | U.S. and global markets are experiencing volatility and disruption following the escalation of geopolitical tensions and the military conflict between Russia and Ukraine. The conflict in Ukraine could lead to market disruptions, including significant volatility in commodity prices, credit and capital markets. Any of the abovementioned factors could affect its business, prospects, financial condition, and operating results. The extent and duration of the military action, sanctions and resulting market disruptions are not possible to predict. |
e. | On October 7, 2023, an 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. The Company's management does not expect this situation to have a material impact on its operations or its business results. As of the date of these financial statements, the war in Israel is ongoing and continues to evolve. The intensity and duration of the war is difficult to predict. |
F - 6
PAINREFORM LTD.
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
F - 7
PAINREFORM LTD.
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
| a. | Warrants and Warrants units |
Type | Issuance Date | Number of warrants | Exercise price | Exercisable through |
August 2019 warrants | August 22, 2019 | 205,268 | $67.20 (*) | August 22, 2024 |
December 2019 warrants | December 9, 2019 | 148,106 | $67.20 (*) | December 8, 2024 |
Warrants to underwriters | September 3, 2020 | 125,000 | $100.00 | September 1, 2025 |
Warrants to underwriters | October 5, 2020 | 375,000 | $88.00 | September 3, 2025 |
IPO warrants | September 3, 2020 | 2,812,170 | $88.00 | September 3, 2025 |
PIPE warrants | March 11, 2021 | 232,500 | $46.00 | September 10, 2026 |
Warrants to PIPE placement agent | March 11,2021 | 52,173 | $50.60 | March 8, 2026 |
December 2023 warrants (**) | December 28, 2023 | 935,792 | $0.80 | April 15, 2029 |
December 2023 warrants | December 28, 2023 | 32,753 | $3.56 | December 28, 2028 |
Warrants issued to investors (***) | April 15, 2024 | 5,000,000 | $0.80 | April 15, 2029 |
Warrants issued to underwriters (***) | April 15, 2024 | 350,000 | $1.00 | April 15, 2029 |
TOTAL | 10,268,762 |
F - 8
PAINREFORM LTD.
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
NOTE 5: SHAREHOLDERS’ EQUITY (Cont.)
F - 9
PAINREFORM LTD.
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
| b. | Share-based compensation: |
| 1. The 2008 Plan: |
Number of options | Weighted average exercise price | Weighted average remaining contractual life | ||||||||||
Options outstanding as of December 31,2023 | 15,388 | $ | 2.40 | 0.25 | ||||||||
Options granted | - | - | - | |||||||||
Options exercised | - | - | - | |||||||||
Options expired | (15,388 | ) | 2.40 | 0.25 | ||||||||
Options outstanding as of June 30, 2024 | - | $ | - | - | ||||||||
Options exercisable as of June 30, 2024 | - | $ | - | - | ||||||||
| 2. The 2019 Plan: |
Number of options | Weighted average exercise price | Weighted average remaining contractual life | ||||||||||
| Options outstanding as of December 31,2023 | 187,994 | $ | 11.94 | 8.69 | ||||||||
| Options granted | - | - | - | |||||||||
| Options exercised | - | - | - | |||||||||
| Options expired | (10,861 | ) | 5.70 | - | ||||||||
| Options outstanding as of June 30, 2024 | 177,133 | $ | 12.32 | 8.18 | ||||||||
| Options exercisable as of June 30, 2024 | 148,132 | $ | 13.59 | 8.07 | ||||||||
F - 10
PAINREFORM LTD.
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
| c. | On April 15, 2024, the Company sold to certain institutional investors an aggregate of (i) 447,500 of its ordinary shares (the “April 2024 Shares”), (ii) 4,552,500 prefunded warrants to purchase 4,552,500 ordinary shares (the “Prefunded Warrants”), and (iii) 5,000,000 warrants to purchase 5,000,000 ordinary shares (the “Investor Warrants”), at a purchase price of $0.80 per April 2024 Share and accompanying Investor Warrant, and $0.7999 per Prefunded Warrant and accompanying Investor Warrant, and (iv) 350,000 warrants to purchase 350,000 ordinary shares at a purchase price of $1.00 were issued to the underwriter resulting in gross proceeds of approximately $4.0 million. The net proceeds from the transaction were $3.3 million. Up to June 30, 2024 the company issued to the investors 994,500 ordinary shares out of the prefunded warrants, leaving 3,558,000 as a prefunded warrants. The Prefunded Warrants and the Investor Warrants and were classified as equity. |
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, prefunded warrants, 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, and warrants, which are included under the treasury stock method when dilutive. For the periods ended June 30, 2024, and 2023, all outstanding share options and warrants have been excluded from the calculation of the diluted net loss per share as all such securities are anti-dilutive for all periods presented. |
F - 11
PAINREFORM LTD.
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
Six Months ended June 30, | ||||||||
2024 | 2023 | |||||||
Bank fees | (9 | ) | (8 | ) | ||||
Interest income | 98 | 190 | ||||||
Exchange rate differences | 3 | (3 | ) | |||||
Total financial income, net | $ | 92 | $ | 179 | ||||
| 1. | An increase in the employees' options pool to 600,000 options for ordinary shares of the company. |
| 2. | A grant of 28,000 options to a company employee with an exercise price of $0.54, every three months 2,333 options will be vested, these options will be expired after 10 years. |
| 1. | To increase the Company’s authorized share capital by 40,000,000 shares, such that following the increase, the authorized share capital shall be divided into 60,000,000 ordinary shares, nominal value NIS 0.3 each, and to amend the Company’s articles of association accordingly. |
| 2. | To cancel the nominal value of the Company’s ordinary shares such that, subject to the approval of Proposal 3, the Company’s authorized share capital will be divided into 60,000,000 ordinary shares with no nominal value, and to amend the Company’s articles of association accordingly. |
| 3. | To approve a reverse split of the Company ordinary shares, so that every six ordinary shares of the Company with no nominal value will be combined into one share and to amend the Company Articles of Association accordingly. As of the August 15, 2024 The reverse split is not effective. The company's pro forma Basic and diluted net loss per share as of June 30, 2024 and 2023 giving retroactive effect to the reverse split, will be 18.69 and 24.70, respectively and the weighted average number of shares of Ordinary Shares used in computing basic and diluted net loss per share as of June 30, 2024 and 2023 will be 685,693 and 181,742, respectively |
