Exhibit 99.2
SOL-GEL TECHNOLOGIES LTD.
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF JUNE 30, 2021
SOL-GEL TECHNOLOGIES LTD.
UNAUDITED CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
AS OF JUNE 30, 2021
TABLE OF CONTENTS
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CONDENSED CONSOLIDATED FINANCIAL STATEMENTS: | |
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The amounts are stated in U.S. dollars in thousands, except share and per share data
SOL-GEL TECHNOLOGIES LTD.
CONDENSED CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
December 31, | June 30, | |||||||
2020 | 2021 | |||||||
A s s e t s | ||||||||
CURRENT ASSETS: | ||||||||
Cash and cash equivalents | $ | 7,122 | $ | 11,152 | ||||
Bank deposits | 21,400 | 20,900 | ||||||
Marketable securities | 21,652 | 6,830 | ||||||
Receivables from collaborative arrangements | 2,153 | 956 | ||||||
Prepaid expenses and other current assets | 1,074 | 1,556 | ||||||
TOTAL CURRENT ASSETS | 53,401 | 41,394 | ||||||
| ||||||||
NON-CURRENT ASSETS: | ||||||||
Restricted long-term deposits and cash | 1,293 | 1,291 | ||||||
Property and equipment, net | 1,817 | 1,397 | ||||||
Operating lease right-of-use assets | 1,896 | 1,579 | ||||||
Funds in respect of employee rights upon retirement | 754 | 744 | ||||||
TOTAL NON-CURRENT ASSETS | 5,760 | 5,011 | ||||||
| ||||||||
TOTAL ASSETS | $ | 59,161 | $ | 46,405 | ||||
Liabilities and shareholders' equity | ||||||||
CURRENT LIABILITIES: | ||||||||
Accounts payable | $ | 1,203 | $ | 1,345 | ||||
Other accounts payable | 4,088 | 3,164 | ||||||
Current maturities of operating leases liabilities | 673 | 649 | ||||||
TOTAL CURRENT LIABILITIES | 5,964 | 5,158 | ||||||
| ||||||||
LONG-TERM LIABILITIES - | ||||||||
Operating leases liabilities | 1,299 | 958 | ||||||
Liability for employee rights upon retirement | 1,049 | 1,042 | ||||||
TOTAL LONG-TERM LIABILITIES | 2,348 | 2,000 | ||||||
COMMITMENTS | ||||||||
TOTAL LIABILITIES | 8,312 | 7,158 | ||||||
| ||||||||
SHAREHOLDERS' EQUITY: | ||||||||
Ordinary Shares, NIS 0.1 par value – authorized: 50,000,000 as of December 31, 2020 and June 30, 2021; issued and outstanding: 23,000,782 and 23,029,951 as of December 31, 2020 and June 30, 2021, respectively. | 635 | 635 | ||||||
Additional paid-in capital | 231,577 | 232,071 | ||||||
Accumulated deficit | (181,363 | ) | (193,459 | ) | ||||
TOTAL SHAREHOLDERS' EQUITY | 50,849 | 39,247 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 59,161 | $ | 46,405 |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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SOL-GEL TECHNOLOGIES LTD.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
Six months ended June 30 | Three months ended June 30 | |||||||||||||||
2020 | 2021 | 2020 | 2021 | |||||||||||||
COLLABORATION REVENUES | $ | 4,598 | $ | 1,629 | $ | 1,133 | $ | 928 | ||||||||
RESEARCH AND DEVELOPMENT EXPENSES | 14,381 | 9,399 | 6,451 | 6,933 | ||||||||||||
GENERAL AND ADMINISTRATIVE EXPENSES | 4,994 | 4,496 | 2,233 | 2,037 | ||||||||||||
TOTAL OPERATING LOSS | 14,777 | 12,266 | 7,551 | 8,042 | ||||||||||||
FINANCIAL INCOME, net | (597 | ) | (170 | ) | (481 | ) | (9 | ) | ||||||||
LOSS FOR THE PERIOD | $ | 14,180 | $ | 12,096 | $ | 7,070 | $ | 8,033 | ||||||||
BASIC AND DILUTED LOSS PER ORDINARY SHARE | $ | 0.64 | $ | 0.53 | $ | 0.31 | $ | 0.35 | ||||||||
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC AND DILUTED LOSS PER SHARE | 22,143,099 | 23,016,104 | 22,920,557 | 23,028,508 |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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SOL-GEL TECHNOLOGIES LTD.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
Ordinary shares | Additional paid-in capital | Accumulated deficit | Total | |||||||||||||||||
Number of shares | Amounts | Amounts | ||||||||||||||||||
BALANCE AS OF JANUARY 1, 2020 | 20,402,800 | 561 | 203,977 | (152,073 | ) | 52,465 | ||||||||||||||
CHANGES DURING THE SIX MONTHS ENDED JUNE 30, 2020: | ||||||||||||||||||||
Loss for the period | (14,180 | ) | (14,180 | ) | ||||||||||||||||
Issuance of shares and warrants through public offering, net of issuance costs | 2,091,907 | 61 | 21,245 | 21,306 | ||||||||||||||||
Issuance of shares and warrants through private placement from the controlling shareholder | 454,628 | 13 | 4,987 | 5,000 | ||||||||||||||||
Vesting of restricted shares units | 19,166 | * | * | * | ||||||||||||||||
Exercise of options | 28,447 | * | 151 | 151 | ||||||||||||||||
Share-based compensation | 779 | 779 | ||||||||||||||||||
BALANCE AT JUNE 30, 2020 | 22,996,948 | 635 | 231,139 | (166,253 | ) | 65,521 | ||||||||||||||
| ||||||||||||||||||||
BALANCE AS OF JANUARY 1, 2021 | 23,000,782 | 635 | 231,577 | (181,363 | ) | 50,849 | ||||||||||||||
CHANGES DURING THE SIX MONTHS ENDED JUNE 30, 2021: | ||||||||||||||||||||
Loss for the period | (12,096 | ) | (12,096 | ) | ||||||||||||||||
Vesting of restricted shares units | 15,333 | * | * | |||||||||||||||||
Exercise of options | 13,836 | * | 83 | 83 | ||||||||||||||||
Share-based compensation | 411 | 411 | ||||||||||||||||||
BALANCE AT JUNE 30, 2021 | 23,029,951 | 635 | 232,071 | (193,459 | ) | 39,247 |
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SOL-GEL TECHNOLOGIES LTD.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
Ordinary shares | Additional paid-in capital | Accumulated deficit | Total | |||||||||||||||||
Number of shares | Amounts | Amounts | ||||||||||||||||||
BALANCE AS OF APRIL 1, 2020 | 22,514,488 | $ | 622 | $ | 225,693 | $ | (159,183 | ) | $ | 67,132 | ||||||||||
CHANGES DURING THE THREE MONTHS ENDED JUNE 30, 2020: | ||||||||||||||||||||
Loss for the period | (7,070 | ) | (7,070 | ) | ||||||||||||||||
Issuance of shares and warrants through private placement from the controlling shareholder | 454,628 | 13 | 4,987 | 5,000 | ||||||||||||||||
Vesting of restricted shares units | 3,833 | * | * | * | ||||||||||||||||
Exercise of options | 23,999 | * | 144 | 144 | ||||||||||||||||
Share-based compensation | 315 | 315 | ||||||||||||||||||
BALANCE AT JUNE 30, 2020 | 22,996,948 | $ | 635 | $ | 231,139 | $ | (166,253 | ) | $ | 65,521 | ||||||||||
| ||||||||||||||||||||
BALANCE AS OF APRIL 1, 2021 | 23,028,264 | 635 | 231,849 | (185,426 | ) | 47,058 | ||||||||||||||
CHANGES DURING THE THREE MONTHS ENDED JUNE 30, 2021: | ||||||||||||||||||||
Loss for the period | (8,033 | ) | (8,033 | ) | ||||||||||||||||
Exercise of options | 1,687 | * | 9 | 9 | ||||||||||||||||
Share-based compensation | 213 | 213 | ||||||||||||||||||
BALANCE AT JUNE 30, 2021 | 23,029,951 | 635 | 232,071 | (193,459 | ) | 39,247 |
* less than $1 thousand.
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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SOL-GEL TECHNOLOGIES LTD.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
Six months ended June 30 | ||||||||
2020 | 2021 | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
Loss | $ | (14,180 | ) | $ | (12,096 | ) | ||
Adjustments required to reconcile loss to net cash used in operating activities: | ||||||||
Depreciation | 470 | 474 | ||||||
Changes in accrued liability for employee rights upon retirement, net | 17 | 3 | ||||||
Share-based compensation | 779 | 411 | ||||||
Financial expenses (income), net | (14 | ) | 15 | |||||
Net changes in operating leases | (30 | ) | (48 | ) | ||||
Changes in fair value of marketable securities | 76 | (59 | ) | |||||
Changes in operating asset and liabilities: | ||||||||
Receivables from collaborative arrangements | 2,949 | 1,197 | ||||||
Prepaid expenses and other current assets | (201 | ) | (482 | ) | ||||
Accounts payable, accrued expenses and other | 553 | (782 | ) | |||||
Net cash used in operating activities | (9,581 | ) | (11,367 | ) | ||||
CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
Purchase of property and equipment | (358 | ) | (54 | ) | ||||
Investment in marketable securities | (19,640 | ) | (4,065 | ) | ||||
Proceeds from sales and maturity of marketable securities | 19,852 | 18,946 | ||||||
Short-term deposits | (19,900 | ) | 500 | |||||
Long-term deposits | (12 | ) | 2 | |||||
Net cash provided by (used in) investing activities | (20,058 | ) | 15,329 | |||||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
Proceed from exercise of options | 151 | 83 | ||||||
Proceeds from issuance of shares, net of issuance costs | 26,306 | - | ||||||
Net cash provided by financing activities | 26,457 | 83 | ||||||
EFFECT OF EXCHANGE RATE ON CASH AND CASH EQUIVALENTS | 14 | (15 | ) | |||||
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | (3,168 | ) | 4,030 | |||||
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF THE PERIOD | 9,762 | 8,272 | ||||||
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AT END OF THE PERIODS | $ | 6,594 | $ | 12,302 | ||||
Cash and Cash equivalents | 5,444 | 11,152 | ||||||
Restricted cash | 1,150 | 1,150 | ||||||
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH SHOWN IN STATEMENT OF CASH FLOWS | 6,594 | 12,302 | ||||||
SUPPLEMENTARY INFORMATION: | ||||||||
Interest received | 628 | 582 |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
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SOL-GEL TECHNOLOGIES LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
NOTE 1 - NATURE OF OPERATIONS
Sol-Gel Technologies Ltd. (collectively with its U.S. subsidiary, the Company) is an Israeli Company incorporated in 1997.
The Company is a clinical stage specialty pharmaceutical company focused on developing and commercializing topical dermatological drug products. The Company’s lead product candidates are based upon its proprietary microencapsulation delivery system, consisting of microcapsules made of precipitated silica. The most advanced investigational drugs in the Company's product pipeline are: (i) Twyneo®, which is developed for the treatment of acne vulgaris and (ii) Epsolay®, a potential treatment for subtype II rosacea. The New Drug Application ("NDA") for Twyneo® was accepted by the U.S. Food and Drug Administration (the “FDA”), which assigned a Prescription Drug User Fee Act ("PDUFA") goal date of August 1, 2021. The NDA for Epsolay® was accepted by the FDA, which assigned a PDUFA goal date of April 26, 2021. On such PDUFA goal date, the Company received confirmation from the FDA that action on the NDA could not be taken since a pre-approval inspection of the production site of Epsolay® still needs to be conducted. In June 2021, the Company entered into two exclusive license agreements with a third party for the commercialization of Twyneo® and Epsolay®, in the United States, see note 5. On July 27, 2021, the Company announced that the FDA approved the drug product, Twyneo®, see note 9. In addition to the novel product candidates, the Company’s products include the generic products Acyclovir, Ivermectin and other generic product candidates.
Risk and Uncertainties
Since incorporation through June 30, 2021, the Company has an accumulated deficit of $193,459 and its activities have been funded mainly by its shareholders and collaboration revenues, see also Notes 4 and 5. The Company expects to continue to incur significant research and development and other costs related to its ongoing operations. In June 2021, the Company entered into two exclusive license agreements with a third party for the commercialization of two of the Company's most advanced investigational drug products in the United States including upfront and milestone payments and related royalties, see note 5.
In addition, management is continuing to analyze cash resources and considering raising additional funding from different sources, such as corporate collaborations, public or private equity offerings and/or debt financings, and/or selling shares under the Company's Open Market Sale Agreement with Jefferies LLC. Management expects that the Company's cash and cash equivalents, deposits and marketable securities as of June 30, 2021 will allow the Company to fund its operating plan through at least the next 12 months from the condensed financial statement issuance date.
The Company is subject to risks and uncertainties as a result of the COVID-19 pandemic.
The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company's business, results of operations and financial condition, including revenues from collaboration arrangements, expenses, reserves and allowances, manufacturing, supply, regulatory approvals, clinical trials, commercial launch of branded and generic product candidates, research and development costs and employee-related amounts, will depend on future developments that are highly uncertain and cannot be predicted. The Company continues to monitor and assess new information related to the COVID-19 pandemic, the actions taken to contain or treat COVID-19, as well as the economic impact on various markets.
Furthermore, the estimation process required to prepare the Company’s consolidated financial statements requires assumptions to be made about future events and conditions and the impact of COVID-19 on its financial results, and while management believes such assumptions are reasonable, they are inherently subjective and uncertain. The Company’s actual results could differ materially from those estimates.
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SOL-GEL TECHNOLOGIES LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES:
a. Basis of Presentation
The unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America ("U.S. GAAP") for interim financial statements. Accordingly, they do not include all of the information and notes required by U.S. GAAP for annual financial statements. In the opinion of management, these unaudited condensed consolidated financial statements reflect all adjustments, which include normal recurring adjustments, necessary for a fair statement of the Company’s consolidated financial position as of June 30, 2021, the consolidated results of operations and the statements of changes in shareholders' equity for the six month and three month periods ended June 30, 2020 and 2021 and the statements of cash flows for the six month period ended June 30, 2020 and 2021.
The consolidated results for the six month period ended June 30, 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2021.
These unaudited condensed consolidated financial statements should be read in conjunction with the audited financial statements of the Company for the year ended December 31, 2020. The comparative balance sheet at December 31, 2020 has been derived from the audited financial statements at that date but does not include all disclosures required by U.S. GAAP.
b. 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 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 equivalents include outstanding stock options, restricted shares and warrants, which are included under the treasury stock method when dilutive. The calculation of diluted loss per share does not include 3,437,843 and 3,463,710 options, restricted shares and warrants for the six and three months ended June 30, 2021 and 1,244,731 and 1,197,028 options and restricted shares for the six and the three months ended June 30, 2020, respectively, because the effect would be anti-dilutive.
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SOL-GEL TECHNOLOGIES LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
NOTE 3 - MARKETABLE SECURITIES:
The following table sets forth the Company’s marketable securities for the indicated periods:
December | June 30, | |||||||
31, 2020 | 2021 | |||||||
Level 2 securities: | ||||||||
U.S government and agency bonds | $ | 4,192 | $ | 2,716 | ||||
Canada government bonds | - | - | ||||||
Other foreign government bonds | 2,006 | - | ||||||
Corporate bonds* | 15,454 | 4,114 | ||||||
Total | $ | 21,652 | $ | 6,830 |
* Investments in Corporate bonds rated A or higher.
The Company’s debt securities are classified within Level 2 because it uses quoted market prices or alternative pricing sources and models utilizing market observable inputs to determine their fair value.
The table below sets forth a summary of the changes in the fair value of the Company’s marketable securities for the indicated periods:
Marketable securities | ||||||||
For the year ended December 31, 2020 | For the Six Months ended June 30, 2021 | |||||||
| ||||||||
Balance at beginning of the period | $ | 40,966 | $ | 21,652 | ||||
Additions | 32,322 | 4,065 | ||||||
Sale or maturity | (51,498 | ) | (18,946 | ) | ||||
Changes in fair value during the period | (138 | ) | 59 | |||||
Balance at end of the period | $ | 21,652 | $ | 6,830 |
As of June 30, 2021, the Company’s debt securities had the following maturity dates:
Market value |
| |||
June 30, 2021 |
| |||
Due within one year | 6,830 |
|
The carrying amount of the cash and cash equivalents, bank deposits, restricted cash, restricted long term deposits, accrued expenses and other liabilities approximates their fair value.
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SOL-GEL TECHNOLOGIES LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
NOTE 4 - COLLABORATION AGREEMENTS:
a. In 2007, the Company granted rights to a third party for use and commercialization of a product for skin protection. Under this agreement, the Company is entitled to royalties during the years 2016 to 2024. Based on current sales, royalties are not material.
b. In 2016 through 2021, the Company entered into several collaboration agreements with two third parties for the development, manufacturing and commercialization of several product candidates. Under the agreements, the third parties are obligated to conduct regulatory, scientific, clinical and technical activities necessary to develop the product and prepare and file ANDA, with the FDA and gain regulatory approval. The Company participates in the development of the product candidates, including participation in joint steering committees and is obligated for sourcing the active pharmaceutical ingredient (API) during the development phase.
Upon FDA approval, the third parties have exclusive rights and are required to use diligent efforts to commercialize these products in territories defined under the agreements, including all required sales, marketing and distributing activities associated with the agreements. The Company is entitled to 50% of the third parties’ gross profits related to the sale of these products, as such term is defined in the agreements.
During the six and three months ended June 30, 2021, respectively, the Company recognized revenues from royalties related to sales of two generic products in the U.S. under these agreements in the amount of $1,582 and $904.
The Agreements are considered to be within the scope of ASC 808, as the parties are active participants and exposed to the risks and rewards of the collaborative activity.
The Company recognizes collaboration revenue when the related sales occur.
NOTE 5 - LICENSE AGREEMENTS:
In June 2021, the Company entered into two exclusive license agreements with a third party for the commercialization of two of the Company most advanced investigational drug products (Twyneo® and Epsolay®) in the United States. The Company is entitled to up to $7.5 million per product in upfront payments and regulatory approval milestone payments assuming 2021 approval of each respective product. The Company is also eligible to receive tiered double-digit royalties ranging from mid-teen to high-teen percentage of net sales as well as up to $9 million in sales milestone payments. According to the agreement, the Company has an option to regain commercialization rights five years following first commercialization. Subsequent to June 30, 2021, the Company received $4 million per product of upfront payments, which are refundable if FDA approval for each respective product is not received by December 31, 2021. As to FDA approval, received subsequent to June 30, 2021, with respect to Twyneo® , see note 9.
NOTE 6 - COMMITMENTS:
In June 2021, the Company entered into a new agreement with a third party for the commercialization of a product candidate. According to the agreement the Company shall receive from the third party an upfront payment of $1,250 and additional milestone payments in the future. In connection with the development of the product candidate, the Company is expected to sign an agreement with another third party. Both third parties are expected to sign a manufacture and supply agreement. In case either the development and/or supply agreements will not be executed during the 3rd quarter of 2021, the Company shall be required to refund the third party with the aforementioned upfront payment. In July 2021, the Company received the upfront payment.
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SOL-GEL TECHNOLOGIES LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
NOTE 7 – SHARE CAPITAL:
Options grants
During the six months ended June 30, 2021, the Company granted 248,600 options to employees and directors:
i.
In January 2021 and March 2021, the Company granted a total of 20,000 options and 3,600 options, respectively, to several employees to purchase ordinary shares at an exercise price of $10.44 and $9.93 per share, respectively. The options vest over a period of 4 years; one quarter of the options vest on the first anniversary of the vesting commencement date (as described in each agreement) and the rest vest quarterly over the following three years. The options expire on the tenth anniversary of their grant date.
ii.
In February 2021, the Company granted a total of 225,000 options to several directors to purchase ordinary shares at an exercise price of $10.02 per share. The options vest over a period of 3 years; one third of the options vest on the first anniversary of the vesting commencement date (as described in each agreement) and the rest vest quarterly over the following two years. The options expire on the tenth anniversary of their grant date.
The fair value of options granted in 2021 was $1,061. The underlying data used for computing the fair value of the options are as follows:
2021 | |||
Value of one ordinary share | $9.56-$10.44 | ||
Dividend yield | 0% | ||
Expected volatility | 59.52%-70.48% | ||
Risk-free interest rate | 0.55%-1.14% | ||
Expected term | 3.25-7 years |
Ordinary shares
On February 19, 2020, the Company completed an underwritten public offering, in which it issued 2,091,907 ordinary shares and 2,091,907 warrants to purchase up to 1,673,525 ordinary shares, at a public offering price of $11.00 per ordinary shares for total proceeds, net of issuance costs of approximately $21,306. The warrants are exercisable over a six-years period from the date of issuance at a per share exercise price of $14, subject to certain adjustments as defined in the agreement.
In addition and in parallel to the public offering, the Company completed private placement with its controlling shareholder for an additional investment of approximately $5,000 in consideration of 454,628 ordinary shares and 454,628 warrants to purchase up to 363,702 ordinary shares, at the same terms of the underwritten public offering mentioned above.
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SOL-GEL TECHNOLOGIES LTD.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(U.S. dollars in thousands, except share and per share data)
(Unaudited)
NOTE 8 - RELATED PARTIES:
a. Related parties include the controlling shareholder and companies under his control, the board of directors and the executive officers of the Company.
b. As to the private placement with the controlling shareholder, see note 7.
NOTE 9 – SUBSEQUENT EVENT:
i. On July 27, 2021, the Company announced that the FDA approved the Company’s first proprietary drug product, Twyneo® . The Company expects to receive a regulatory milestone payment in conjunction with this approval under the exclusive license executed in June 2021 related to the commercialization of Twyneo® and retains the option to regain U.S. commercialization rights five years following first commercialization in the U.S. FDA approval of Twyneo®.
ii. In July 2021, the Company received the upfront payment related to a new agreement with a third party for the commercialization of a product candidate, see Note 6.
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