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Share Name | Share Symbol | Market | Type |
---|---|---|---|
PainReform Ltd | NASDAQ:PRFX | NASDAQ | Common Stock |
Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|---|---|
-0.03 | -3.70% | 0.78 | 0.7215 | 2.50 | 0.8499 | 0.78 | 0.791 | 14,683 | 05:00:02 |
99.1
|
Unaudited Condensed Financial Statements as of June 30, 2023
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|
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99.2
|
Operating and Financial Review as of June 30, 2023 and for the six months then ended
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|
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99.3
|
Press Release dated August 10, 2023
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Exhibit No.
|
Description
|
|
|
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|
|
Date: August 10, 2023
|
PAINREFORM LTD.
|
||
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||
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By:
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/s/ Ilan Hadar
|
|
|
|
Ilan Hadar
|
|
|
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Chief Executive Officer
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Page | |
F-2 | |
F-3 | |
F-4 | |
F-5 | |
F-6 - F-11 |
|
As of
June 30,
|
As of
December 31,
|
||||||
|
2023
|
2022
|
||||||
Assets
|
||||||||
Current assets:
|
||||||||
Cash and cash equivalents
|
$
|
|
$
|
|
||||
Short term deposit
|
|
|
||||||
Restricted cash
|
|
|
||||||
Prepaid clinical trial expenses and deferred clinical trial costs
|
|
|
||||||
Prepaid expenses and other current assets
|
|
|
||||||
|
||||||||
Total current assets
|
|
|
||||||
|
||||||||
Property and equipment, net
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|
|
||||||
|
||||||||
Total assets
|
$
|
|
$
|
|
||||
|
||||||||
Liabilities and shareholders’ equity
|
||||||||
|
||||||||
Current liabilities:
|
||||||||
Trade payables
|
$
|
|
$
|
|
||||
Employees and related liabilities
|
|
|
||||||
Accrued expenses
|
|
|
||||||
|
||||||||
Total current liabilities
|
|
|
||||||
|
||||||||
Non-current liabilities:
|
||||||||
Provision for uncertain tax positions
|
|
|
||||||
Total non-current liabilities
|
|
|
||||||
|
||||||||
Total liabilities
|
|
|
||||||
|
||||||||
Commitments (Note 6)
|
||||||||
|
||||||||
Shareholders’ equity:
|
||||||||
Ordinary shares, NIS
|
|
|
||||||
Additional paid-in capital
|
|
|
||||||
Accumulated deficit
|
(
|
)
|
(
|
)
|
||||
|
||||||||
Total shareholders’ equity
|
|
|
||||||
|
||||||||
Total liabilities and shareholders’ equity
|
$
|
|
$
|
|
F - 2
|
For the Six Months Ended
June 30, |
||||||||||
|
Note
|
2023
|
2022
|
||||||||
|
|||||||||||
Operating expenses:
|
|||||||||||
Research and development expenses
|
$
|
(
|
)
|
$
|
(
|
)
|
|||||
General and administrative expenses
|
(
|
)
|
(
|
)
|
|||||||
|
|||||||||||
Operating loss
|
(
|
)
|
(
|
)
|
|||||||
|
|||||||||||
Financial income, net
|
7
|
|
|
||||||||
|
|||||||||||
Net loss and comprehensive loss
|
$
|
(
|
)
|
$
|
(
|
)
|
|||||
|
|||||||||||
Basic and diluted net loss per share(*)
|
5
|
$
|
(
|
)
|
$
|
(
|
)
|
||||
|
|||||||||||
Weighted average number of shares of Ordinary Shares used in computing basic and diluted net loss per share
|
|
|
F - 3
|
Ordinary shares(**)
|
Additional paid-in
capital
|
Accumulated
deficit
|
Total
shareholders’ equity
|
||||||||||||||||
Number
|
Amount
|
|||||||||||||||||||
|
||||||||||||||||||||
Balance as of January 1, 2022
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
|
||||||||||||||||||||
Share-based compensation to employees and directors
|
-
|
|
|
|
|
|||||||||||||||
|
||||||||||||||||||||
Share-based compensation to service providers
|
-
|
|
|
|
|
|||||||||||||||
Share issuance to service providers
|
|
|
|
|||||||||||||||||
Net loss and comprehensive loss
|
-
|
|
|
(
|
)
|
(
|
)
|
|||||||||||||
|
||||||||||||||||||||
Balance as of June 30, 2022
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
Balance as of January 1, 2023
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
||||||||||
Share-based compensation to employees and directors
|
-
|
|
|
|
|
|||||||||||||||
Share issuance to service providers
|
|
|
|
|
|
|||||||||||||||
Net loss and comprehensive loss
|
|
|
(
|
)
|
(
|
)
|
||||||||||||||
Balance as of June 30, 2023
|
|
$
|
|
$
|
|
$
|
(
|
)
|
$
|
|
F - 4
|
For the Six Months Ended
June 30, |
|||||||
|
2023
|
2022
|
||||||
Cash flows from operating activities
|
||||||||
|
||||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||
Depreciation
|
|
|
||||||
Exchange rate differences on cash, cash equivalents and restricted cash
|
|
|
||||||
Share-based compensation to employees and directors
|
|
|
||||||
Share-based compensation to service providers
|
|
|||||||
Interest income, net
|
|
|
||||||
Change in:
|
||||||||
Other current assets
|
(
|
)
|
|
|||||
Trade payables
|
(
|
)
|
|
|||||
Other accounts payable
|
|
(
|
)
|
|||||
|
||||||||
Net cash used in operating activities
|
(
|
)
|
(
|
)
|
||||
|
||||||||
Cash flows from investing activities
|
||||||||
|
||||||||
Purchase of property and equipment
|
|
(
|
)
|
|||||
Purchase of short-term deposit
|
(
|
)
|
|
|||||
Proceeds from short term deposit
|
|
|
||||||
|
||||||||
Net cash provided by investing activities
|
|
(
|
)
|
|||||
Cash flows from financing activities
|
||||||||
Net cash provided by financing activities
|
|
|
||||||
|
||||||||
Effect of Exchange rate changes on cash, cash equivalents and restricted cash
|
(
|
)
|
|
|||||
Change in cash, cash equivalents and restricted cash
|
|
(
|
)
|
|||||
Cash, cash equivalents and restricted cash at the beginning of the period
|
|
|
||||||
|
||||||||
Cash, cash equivalents and restricted cash at the end of the period
|
$
|
|
$
|
|
|
As of June 30,
|
|||||||
|
2023
|
2022
|
||||||
|
||||||||
Cash and cash equivalents
|
$
|
|
$
|
|
||||
Restricted cash
|
|
|
||||||
Total cash, cash equivalents and restricted cash
|
$
|
|
$
|
|
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
|
c. |
The Company’s supplier of the API (active pharmaceutical ingredient) has received a deficiency notice from the FDA related to its Drug Master File (DMF). The DMF is the file on record with FDA representing the manufacturing process and facility for the production of the API. As a result, the second part of Phase 3 trial is expected to commence once the FDA completes the review of the information provided by the supplier to the FDA and the deficiency notice has been resolved. None of the issues raised relate to the Company’s PRF-110 product.
|
F - 6
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
NOTE 1: GENERAL (Cont.)
d. |
The Company reports its financial results in U.S. dollars. A portion of research, development, 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 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 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 or precedes such appreciation. The Israeli rate of inflation did not have a material adverse effect on our financial condition during the six months ended June 30, 2023 and 2022, respectively. 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.
|
e. |
In June 2023, the Company effected a reverse share split of its shares at the ratio of
|
f. |
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 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 - 7
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
|
|
|
$
|
|
December 2019 warrants
|
|
|
$
|
|
Warrants 2019 Convertible Notes to placement agent
|
|
|
$
|
|
Warrants to underwriters
|
|
|
$
|
|
Warrants to underwriters
|
|
|
$
|
|
IPO warrants
|
|
|
$
|
|
PIPE warrants
|
|
|
$
|
|
Warrants to PIPE placement agent
|
|
|
$
|
|
TOTAL
|
|
|
|
|
F - 8
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, 2022
|
|
$
|
|
|
||||||||
Options granted
|
|
|
-
|
|||||||||
Options exercised
|
|
|
-
|
|||||||||
Options forfeited
|
|
|
-
|
|||||||||
Options outstanding as of June 30, 2023
|
|
$
|
|
|
||||||||
|
||||||||||||
Options exercisable as of June 30, 2023
|
|
$
|
|
|
2. |
The 2019 Plan:
|
|
Number
of options(*)
|
Weighted
average
exercise price(*)
|
Weighted
average
remaining
contractual
life
|
|||||||||
|
||||||||||||
Options outstanding as of December 31, 2022
|
|
$
|
|
|
||||||||
Options granted
|
|
|
9.95
|
|||||||||
Options exercised
|
|
|
-
|
|||||||||
Options forfeited
|
|
|
-
|
|||||||||
Options outstanding as of June 30, 2023
|
|
$
|
|
|
||||||||
|
||||||||||||
Options exercisable as of June 30, 2023
|
|
$
|
|
|
F - 9
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
c.
|
In April 2022, the Company issued
|
d.
|
In June 2023,
|
F - 10
NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS
U.S. dollars in thousands, except share and per share data
|
Six Months ended
June 30,
|
|||||||
|
2023
|
2022
|
||||||
|
||||||||
Bank fees
|
(
|
)
|
(
|
)
|
||||
Interest income
|
|
|
||||||
Exchange rate differences
|
(
|
)
|
|
|||||
Total financial income, net
|
$
|
|
$
|
|
- |
On July 14, 2023, the Company sold to a certain institutional investor an aggregate of
|
- |
On July 18, 2023, the Company sold to a certain institutional investor an aggregate of
|
• |
our ability to continue as a going concern;
|
• |
our history of losses and needs for additional capital to fund our operations and our ability to obtain additional capital on acceptable terms, or at all;
|
• |
our dependence on the success of our initial product candidate, PRF-110;
|
• |
the outcomes of preclinical studies, clinical trials and other research regarding PRF-110 and future product candidates;
|
• |
fluctuations in inflation and interest in Israel and the United States;
|
• |
our limited experience managing clinical trials;
|
• |
our ability to retain key personnel and recruit additional employees;
|
• |
our reliance on third parties for the conduct of clinical trials, product manufacturing and development;
|
• |
the impact of competition and new technologies;
|
• |
our ability to comply with regulatory requirements relating to the development and marketing of our product candidates;
|
• |
our ability to establish and maintain strategic partnerships and other corporate collaborations;
|
• |
the implementation of our business model and strategic plans for our business and product candidates;
|
• |
the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others;
|
• |
the overall global economic environment;
|
• |
our ability to develop an active trading market for our ordinary shares and whether the market price of our ordinary shares is volatile; and
|
• |
statements as to the impact of the political and security situation in Israel on our business.
|
• |
continue the ongoing and planned preclinical and clinical development of our drug candidates;
|
• |
build a portfolio of drug candidates through the acquisition or in-license of drugs, drug candidates or technologies;
|
• |
initiate preclinical studies and clinical trials for any additional drug candidates that we may pursue in the future;
|
• |
seek marketing approvals for our current and future drug candidates that successfully complete clinical trials;
|
• |
establish a sales, marketing and distribution infrastructure to commercialize any drug candidate for which we may obtain marketing approval;
|
• |
develop, maintain, expand and protect our intellectual property portfolio;
|
• |
implement operational, financial and management systems; and
|
• |
attract, hire and retain additional administrative, clinical, regulatory and scientific personnel.
|
• |
employee-related expenses, including salaries, benefits and stock-based compensation expense;
|
• |
fees paid to consultants for services directly related to our drug development and regulatory effort;
|
• |
expenses incurred under contract manufacturing organizations, as well as contract manufacturing organizations and consultants that conduct preclinical studies and clinical trials;
|
• |
costs associated with development activities;
|
• |
costs associated with technology and intellectual property licenses; and
|
• |
milestone payments and other costs under licensing agreements.
|
• |
number of clinical trials required for approval and any requirement for extension trials;
|
• |
per patient trial costs;
|
• |
number of patients that participate in the clinical trials;
|
• |
number of sites included in the clinical trials;
|
• |
countries in which the clinical trial is conducted;
|
• |
length of time required to enroll eligible patients;
|
• |
potential additional safety monitoring or other studies requested by regulatory agencies; and
|
• |
efficacy and safety profile of the drug candidate.
|
|
Six Months Ended
June 30,
|
|||||||
|
2023
|
2022
|
||||||
(US$ thousands)
|
||||||||
Statements of comprehensive loss data:
|
||||||||
Research and development
|
(2,700
|
)
|
(1,423
|
)
|
||||
General and administrative
|
(1,968
|
)
|
(2,094
|
)
|
||||
Total operating loss
|
(4,668
|
)
|
(3,517
|
)
|
||||
Financial income, net
|
179
|
-
|
||||||
Net loss
|
(4,489
|
)
|
(3,517
|
)
|
• |
the costs, timing and outcome of regulatory review of PRF-110;
|
• |
the scope, progress, results and costs of our current and future clinical trials of PRF-110 for our current targeted uses;
|
• |
the extent to which we acquire or invest in businesses, products and technologies, including entering into or maintaining licensing or collaboration arrangements for PRF-110 on favorable terms, although we currently have no commitments
or agreements to complete any such transactions;
|
• |
the costs and timing of future commercialization activities, including drug sales, marketing, manufacturing and distribution, for any of our product candidates for which we receive marketing approval, to the extent that such sales,
marketing, manufacturing and distribution are not the responsibility of any collaborator that we may have at such time;
|
• |
the amount of revenue, if any, received from commercial sales of PRF-110, should it receive marketing approval;
|
• |
the costs of preparing, filing and prosecuting patent applications, maintaining, defending and enforcing our intellectual property rights and defending intellectual property-related claims;
|
• |
our ability to establish strategic collaborations, licensing or other arrangements and the financial terms of any such agreements, including the timing and amount of any future milestone, royalty or other payments due under any such
agreement;
|
• |
our headcount growth and associated costs as we expand our business operations and our research and development activities;
|
• |
the costs of operating as a public company;
|
• |
maintaining minimum shareholders’ equity requirements under the Nasdaq rules; and
|
• |
the impact of the COVID-19 pandemic and the Russian invasion of Ukraine, which may exacerbate the magnitude of the factors discussed above.
|
|
Six months
Ended June 30,
2023
|
Six months
Ended June 30,
2022
|
||||||
Net cash used in operating activities
|
$
|
(3,955
|
)
|
$
|
(2,699
|
)
|
||
Net cash provided by (used in) investing activities
|
5,000
|
(3
|
)
|
|||||
Net cash provided by financing activities
|
-
|
-
|
||||||
Effect of Exchange rate changes on cash, cash equivalents and restricted cash
|
(3
|
)
|
-
|
|||||
Increase (decrease) in cash and cash equivalents and restricted cash
|
1,042
|
(2,702
|
)
|
|||||
Cash and cash equivalents and restricted cash, at the beginning of period
|
4,106
|
16,571
|
||||||
Cash and cash equivalents and restricted cash, at the end of period
|
$
|
5,148
|
$
|
13,869
|
• |
number of clinical trials required for approval and any requirement for extension trials;
|
• |
per patient trial costs;
|
• |
number of patients that participate in the clinical trials;
|
• |
number of sites included in the clinical trials;
|
• |
countries in which the clinical trial is conducted;
|
• |
length of time required to enroll eligible patients;
|
• |
potential additional safety monitoring or other studies requested by regulatory agencies; and
|
• |
efficacy and safety profile of the drug candidate.
|
Document And Entity Information |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
Cover Abstract | |
Entity Registrant Name | PainReform Ltd. |
Document Type | 6-K |
Current Fiscal Year End Date | --12-31 |
Amendment Flag | false |
Entity Central Index Key | 0001801834 |
Document Period End Date | Jun. 30, 2023 |
Document Fiscal Year Focus | 2023 |
Document Fiscal Period Focus | Q2 |
Entity File Number | 001-39481 |
Entity Address, Address Line One | 65 Yigal Alon |
Entity Address, City or Town | St., Tel Aviv |
Entity Address, Postal Zip Code | 6744316 |
Entity Address, Country | IL |
CONDENSED BALANCE SHEETS (Parentheticals) - ₪ / shares |
Jun. 30, 2023 |
Dec. 31, 2022 |
|||
---|---|---|---|---|---|
Statement of Financial Position [Abstract] | |||||
Ordinary shares, par value (in New Shekels per share) | ₪ 0.3 | [1] | ₪ 0.3 | ||
Ordinary shares, shares authorized | 5,000,000 | [1] | 5,000,000 | ||
Ordinary shares, shares issued | [1] | 1,090,452 | 1,081,755 | ||
Ordinary shares, shares outstanding | 1,090,452 | 1,081,755 | |||
|
CONDENSED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands |
6 Months Ended | |||
---|---|---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
|||
Operating expenses: | ||||
Research and development expenses | $ (2,700) | $ (1,423) | ||
General and administrative expenses | (1,968) | (2,094) | ||
Operating loss | (4,668) | (3,517) | ||
Financial income, net | 179 | 0 | ||
Net loss and comprehensive loss | $ (4,489) | $ (3,517) | ||
Basic net loss per share | $ (4.12) | $ (3.25) | ||
Diluted net loss per share | [1] | $ (4.12) | $ (3.25) | |
Weighted average number of shares of ordinary shares used in computing basic net loss per share | 1,090,452 | 1,081,755 | ||
Weighted average number of shares of ordinary shares used in computing diluted net loss per share | 1,090,452 | 1,081,755 | ||
|
CONDENSED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY - USD ($) $ in Thousands |
Ordinary shares |
Additional paid-in capital |
Accumulated deficit |
Total |
||||||
---|---|---|---|---|---|---|---|---|---|---|
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 | 430 | 0 | 430 | ||||||
Share-based compensation to service providers | 0 | [1] | 206 | 0 | 206 | |||||
Shares issuance to service providers | [2] | [1] | ||||||||
Shares issuance to service providers (in Shares) | [1] | 15,211 | ||||||||
Net loss and comprehensive loss | $ 0 | [1] | 0 | (3,517) | (3,517) | |||||
Balance at Jun. 30, 2022 | $ 94 | [1] | 42,351 | (27,244) | 15,201 | |||||
Balance (in Shares) at Jun. 30, 2022 | [1] | 1,081,755 | ||||||||
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] | 441 | 0 | 441 | |||||
Shares issuance to service providers | [1],[2] | 0 | 0 | [2] | ||||||
Shares issuance to service providers (in Shares) | [1] | 8,697 | ||||||||
Net loss and comprehensive loss | $ 0 | [1] | 0 | (4,489) | (4,489) | |||||
Balance at Jun. 30, 2023 | $ 94 | [1] | $ 43,887 | $ (37,008) | $ 6,973 | |||||
Balance (in Shares) at Jun. 30, 2023 | [1] | 1,090,452 | ||||||||
|
GENERAL |
6 Months Ended | ||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 30, 2023 | |||||||||||||||
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||||||||||||
GENERAL |
NOTE 1: GENERAL
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 $4,489 and $3,517 for the six-month periods ended on June 30, 2023 and 2022, respectively. During the six months ended June 30, 2023, and 2022, the Company had negative operating cash outflows of $3,955, and $2,699, respectively. The Company expects to continue to incur losses and negative cash flows from operations until its product reaches profitability. As of June 30, 2023, the Company’s accumulated deficit was $37,008. The Company has funded its operations to date primarily through equity financing and has cash on hand (including restricted cash and deposits) in the amount of $6,162 as of June 30, 2023.
In July 2023, the Company consummated two registered direct offerings of Ordinary Shares and simultaneous private placements of warrants in the amount of $4.2 million, the net proceeds were $3.6 million (Note 9).
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, 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, 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.
|
UNAUDITED CONDENSED FINANCIAL STATEMENTS |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
Condensed Financial Information Disclosure [Abstract] | |
UNAUDITED CONDENSED FINANCIAL STATEMENTS |
NOTE 2: UNAUDITED CONDENSED FINANCIAL STATEMENTS
The unaudited condensed financial statements included herein have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and, on the same basis as the audited financial statements included in the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2022 (the “2022 Form 20-F”).
Certain information and disclosures normally included in annual financial statements have been omitted in this interim period report pursuant to the rules and regulations of the Securities and Exchange Commission (the "SEC"). Because the unaudited condensed financial statements do not include all of the information and disclosures required by U.S. GAAP for annual financial statements, they should be read in conjunction with the audited financial statements and notes included in the 2022 Form 20-F.
The year-end balance sheet data were derived from the audited financial statements as of December 31, 2022, but not all disclosures required by generally accepted accounting principles in the United States (“U.S. GAAP”) are included.
In the opinion of management, all adjustments (consisting only of normal recurring accruals) considered necessary for a fair statement of the Company’s financial position as of June 30, 2023 and its results of operations and cash flows for the six months ended June 30, 2023 and 2022 have been included. Operating results for the six months ended June 30, 2023, are not necessarily indicative of the results that may be expected for the year ending December 31, 2023 or any other interim period or for any other future year.
|
SIGNIFICANT ACCOUNTING POLICIES |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES |
NOTE 3: SIGNIFICANT ACCOUNTING POLICIES
The significant accounting policies that have been applied in the preparation of the unaudited condensed financial statements are consistent with those that were applied in preparation of the Company’s most recent annual financial statements in connection with its Annual Report on Form 20-F.
|
SHAREHOLDERS' EQUITY |
6 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stockholders' Equity Note [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
SHAREHOLDERS’ EQUITY |
NOTE 4: SHAREHOLDERS’ EQUITY
The following table summarizes the warrants and warrants units outstanding as of June 30, 2023:
(*) Each 10 warrants are exercisable into one IPO unit consisting of one share and one IPO warrant with an exercise price of $88.0 (Note 4d).
(**) Exercise prices amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split (Note 4d).
Share options outstanding and exercisable to employees and directors under the 2008 Share Option Plan (the “2008 Plan”) as of June 30, 2023 and December 31, 2022 were as follows:
(*) Figures were adjusted according to reverse share split (Note 4d)
Share options outstanding and exercisable to employees and directors under the 2019 Share Option Plan (the “2019 Plan”) as of June 30, 2023 and December 31, 2022, were as follows:
(*) Figures were adjusted according to reverse share split (note 4d)
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 thirty-six months, so that 1/24 of the options shall vest on the last day of each three-month period, 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.
|
LOSS PER SHARE |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
Earnings Per Share [Abstract] | |
LOSS PER SHARE |
NOTE 5: 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 periods ended June 30, 2023, and 2022, 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 periods presented.
|
COMMITMENTS AND CONTINGENCIES |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS AND CONTINGENCIES |
NOTE 6: COMMITMENTS AND CONTINGENCIES
On November 13, 2020, the Company entered into a Master Clinical Research Organization Agreement (the "First Agreement"), and on December 3, 2020, the Company entered into a Master Clinical Trial Agreement (the "Second Agreement") both with Lotus Clinical Research as the Company's clinical research organization for the Company's planned Phase 3 trials of PRF-110, which started to take place in March 2023. During the fourth quarter of 2022 and throughout the first quarter of 2023 the Company and the Clinical Research Organization (the "CRO") negotiated the term of the First and the Second Agreements and mutually agreed to update the total milestone completion payment to $5.6 million and to update the payment for the actual number of evaluable subjects to $8.6 million.
Clinical trial expenses are charged to research and development expenses as incurred. The Company accrues expenses resulting from obligations under contracts with its 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.
As of June 30, 2023, the Company accounted for amounts of net $1,962 as prepaid clinical trial expenses and deferred clinical trial costs after recognizing cumulative costs of $3,271 in clinical trial expenses through June 2023. During the six months ended June 2023, the Company recognized clinical trial expenses of $2,042.
|
FINANCIAL INCOME, NET |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure Text Block Supplement [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
FINANCIAL INCOME, NET |
NOTE 7: FINANCIAL INCOME, NET
|
FINANCIAL INSTRUMENTS |
6 Months Ended |
---|---|
Jun. 30, 2023 | |
Financial Instruments [Abstract] | |
FINANCIAL INSTRUMENTS |
NOTE 8: FINANCIAL INSTRUMENTS
The carrying amount of cash equivalents, restricted cash, account payables and accrued expenses approximate their fair value due to their short-term characteristics.
|
SUBSEQUENT EVENTS |
6 Months Ended | ||||||
---|---|---|---|---|---|---|---|
Jun. 30, 2023 | |||||||
Subsequent Events [Abstract] | |||||||
SUBSEQUENT EVENTS |
NOTE 9: SUBSEQUENT EVENTS
|
SHAREHOLDERS' EQUITY (Tables) |
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Jun. 30, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stockholders' Equity Note [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of warrants and warrants units outstanding |
(*) Each 10 warrants are exercisable into one IPO unit consisting of one share and one IPO warrant with an exercise price of $88.0 (Note 4d).
(**) Exercise prices amounts have been retroactively adjusted to reflect a 1-for-10 reverse share split (Note 4d).
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Schedule of share options outstanding and exercisable to employees and directors |
(*) Figures were adjusted according to reverse share split (Note 4d)
(*) Figures were adjusted according to reverse share split (note 4d)
|
FINANCIAL INCOME, NET (Tables) |
6 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Jun. 30, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disclosure Text Block Supplement [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of financial income, net |
|
GENERAL (Detail Textuals) - USD ($) $ in Thousands |
1 Months Ended | 6 Months Ended | ||
---|---|---|---|---|
Jul. 31, 2023 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
|
Nature Of Operations [Line Items] | ||||
Net loss | $ 4,489 | $ 3,517 | ||
Negative operating cash outflows | 3,955 | $ 2,699 | ||
Accumulated deficit | 37,008 | $ 32,519 | ||
Cash on hands | $ 6,162 | |||
Stockholders' Equity, Reverse Stock Split | 1-for-10 | |||
Subsequent Event [Member] | Private Placement [Member] | ||||
Nature Of Operations [Line Items] | ||||
Proceeds from issuance of ordinary shares under Private Investment in Public Equity | $ 3,600 | |||
Proceeds from issuance of warrants | $ 4,200 |
SHAREHOLDERS' EQUITY - (Narrative) (Details) $ / shares in Units, $ in Thousands |
5 Months Ended | 6 Months Ended | 12 Months Ended | 29 Months Ended | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Jun. 08, 2023
₪ / shares
$ / shares
|
Jun. 08, 2023
₪ / shares
shares
|
Jun. 30, 2023
₪ / shares
shares
|
Dec. 31, 2022
USD ($)
|
Dec. 31, 2022
USD ($)
|
Feb. 23, 2023
₪ / shares
|
Dec. 31, 2022
₪ / shares
shares
|
May 31, 2022
shares
|
Apr. 20, 2022
shares
|
||||||
Class of Stock [Line Items] | ||||||||||||||
Reverse share split | 1-for-10 | |||||||||||||
Description of stock split | 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 split, 18,338 shares were added, bringing the Company’s total outstanding shares on a post-split basis to 1,090,452. | |||||||||||||
Average expected term | 5 years 4 months 9 days | |||||||||||||
Risk free interest rate | 3.85% | |||||||||||||
Volatility | 90.43% | |||||||||||||
Dividend yield | 0.00% | |||||||||||||
Grant date fair value per option | ₪ / shares | ₪ 3.2 | ₪ 3.2 | ||||||||||||
Ordinary shares, shares issued | shares | [1] | 1,090,452 | 1,081,755 | |||||||||||
Granted, Number of options | shares | 18,000 | |||||||||||||
Granted, Weighted average exercise price | $ / shares | [2] | ₪ 5.89 | ||||||||||||
Ordinary shares, par value (in New Shekels per share) | ₪ / shares | ₪ 0.3 | [1] | ₪ 0.3 | |||||||||||
Consultant [Member] | ||||||||||||||
Class of Stock [Line Items] | ||||||||||||||
Ordinary shares, shares issued | shares | 8,697 | 8,697 | 15,211 | |||||||||||
Ordinary shares, par value (in New Shekels per share) | ₪ / shares | ₪ 0.3 | |||||||||||||
Share-based compensation expense | $ | $ 67 | $ 822 | ||||||||||||
|
SHAREHOLDERS' EQUITY - Schedule of share options outstanding and exercisable to employees and directors (Details) - $ / shares |
5 Months Ended | 6 Months Ended | |||||||
---|---|---|---|---|---|---|---|---|---|
Jun. 08, 2023 |
Jun. 08, 2023 |
Jun. 30, 2023 |
Jun. 30, 2022 |
Dec. 31, 2022 |
|||||
Schedule Of Share Options Outstanding And Exercisable To Employees And Directors [Line Items] | |||||||||
Granted, Number of options | 18,000 | ||||||||
Granted, Weighted average exercise price | [1] | $ 5.89 | |||||||
Ordinary shares, shares issued | [2] | 1,090,452 | 1,081,755 | ||||||
2008 Plan [Member] | |||||||||
Schedule Of Share Options Outstanding And Exercisable To Employees And Directors [Line Items] | |||||||||
Option outstanding at beginning, Number of options | [1] | 15,388 | 15,388 | ||||||
Option outstanding at beginning, Weighted average exercise price | [1] | $ 2.4 | $ 2.4 | ||||||
Option outstanding at beginning, Weighted average remaining contractual life | 9 months | 1 year 3 months | |||||||
Granted, Number of options | [1] | 0 | |||||||
Granted, Weighted average exercise price | [1] | $ 0 | |||||||
Exercised, Number of options | [1] | 0 | |||||||
Exercised, Weighted average exercise price | [1] | $ 0 | |||||||
Forfeited, Number of options | [1] | 0 | |||||||
Forfeited, Weighted average exercise price | [1] | $ 0 | |||||||
Option outstanding at ending, Number of options | [1] | 15,388 | |||||||
Option outstanding at ending, Weighted average exercise price | [1] | $ 2.4 | |||||||
Options exercisable, Number of options | [1] | 15,388 | |||||||
Options exercisable, Weighted average exercise price | [1] | $ 2.4 | |||||||
Options exercisable, Weighted average remaining contractual life | 9 months | ||||||||
2019 Plan [Member] | |||||||||
Schedule Of Share Options Outstanding And Exercisable To Employees And Directors [Line Items] | |||||||||
Option outstanding at beginning, Number of options | [1] | 133,994 | 133,994 | ||||||
Option outstanding at beginning, Weighted average exercise price | [1] | $ 14.4 | $ 14.4 | ||||||
Option outstanding at beginning, Weighted average remaining contractual life | 9 years 2 months 12 days | 9 years 4 months 20 days | |||||||
Granted, Number of options | [1] | 54,000 | |||||||
Granted, Weighted average exercise price | [1] | $ 5.89 | |||||||
Exercised, Number of options | [1] | 0 | |||||||
Exercised, Weighted average exercise price | [1] | $ 0 | |||||||
Forfeited, Number of options | [1] | 0 | |||||||
Forfeited, Weighted average exercise price | [1] | $ 0 | |||||||
Option outstanding at ending, Number of options | [1] | 187,994 | |||||||
Option outstanding at ending, Weighted average exercise price | [1] | $ 11.94 | |||||||
Options exercisable, Number of options | [1] | 116,416 | |||||||
Options exercisable, Weighted average exercise price | $ 13.19 | ||||||||
Options exercisable, Weighted average remaining contractual life | 9 years 18 days | ||||||||
Employee Stock [Member] | 2019 Plan [Member] | |||||||||
Schedule Of Share Options Outstanding And Exercisable To Employees And Directors [Line Items] | |||||||||
Granted, Number of options | 54,000 | ||||||||
|
COMMITMENTS AND CONTINGENCIES (Detail Textuals) - USD ($) $ in Thousands |
6 Months Ended | |
---|---|---|
Jun. 30, 2023 |
Dec. 31, 2022 |
|
Purchase Commitment, Excluding Long-Term Commitment [Line Items] | ||
Total milestone completion payment | $ 5,600 | |
Total payment for actual number of evaluable subjects | 8,600 | |
Deferred Costs, Noncurrent | 1,962 | |
Prepaid clinical trial expenses and deferred clinical trial costs | 1,962 | $ 1,728 |
Clinical trial expense | 3,271 | |
Recognized clinical trial expenses | $ 2,042 |
FINANCIAL INCOME, NET - Schedule of financial income, net (Details) - USD ($) $ in Thousands |
6 Months Ended | |
---|---|---|
Jun. 30, 2023 |
Jun. 30, 2022 |
|
Schedule of financial expenses, net [Abstract] | ||
Bank fees | $ (8) | $ (7) |
Interest income | 190 | 0 |
Exchange rate differences | (3) | 7 |
Total financial expenses, net | $ 179 | $ 0 |
SUBSEQUENT EVENTS (Narrative) (Details) - Subsequent Event - Private Placement [Member] - USD ($) |
1 Months Ended | ||
---|---|---|---|
Jul. 14, 2023 |
Jul. 31, 2023 |
Jul. 18, 2023 |
|
Subsequent Event [Line Items] | |||
Net proceeds from transaction | $ 3,600,000 | ||
Proceeds from Issuance of Warrants | $ 4,200,000 | ||
Institutional Investor [Member] | |||
Subsequent Event [Line Items] | |||
Net proceeds from transaction | $ 2,300,000 | $ 1,300,000 | |
Sale of stock | 117,930 | 145,000 | |
Purchase price per shares | $ 9 | $ 9 | |
Warrants issue to purchase ordinary shares | 183,300 | 21,666 | |
Proceeds from Issuance of Warrants | $ 8,999 | $ 8,999 | |
Proceeds from Warrant Exercises | $ 2,700,000 | $ 1,500,000 | |
Unregistered warrants issued | 301,230 | 166,666 | |
Exercise price (in Dollars per share) | $ 9 | $ 9 | |
Cash placement fee | $ 176,200 | $ 97,500 | |
Expenses reimbursement | $ 50,000 | $ 30,000 | |
Warrant term | 5 years | 5 years | |
Expiration period of warrants from issuance date | The warrants may be exercised on a cashless basis if at the time of exercise thereof, there is no effective registration statement registering the Ordinary Shares underlying the warrants. | The warrants may be exercised on a cashless basis if at the time of exercise thereof, there is no effective registration statement registering the Ordinary Shares underlying the warrants. |
1 Year PainReform Chart |
1 Month PainReform Chart |
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