Document and Entity Information
Document and Entity Information | 6 Months Ended |
Jun. 30, 2023 | |
Cover [Abstract] | |
Entity Central Index Key | 0001684693 |
Current Fiscal Year End Date | --12-31 |
Document Fiscal Year Focus | 2023 |
Document Fiscal Period Focus | Q2 |
Amendment Flag | false |
Document Type | 6-K |
Document Period End Date | Jun. 30, 2023 |
Entity Registrant Name | SOL-GEL TECHNOLOGIES LTD. |
Entity Address, Address Line One | 7 Golda Meir Street |
Entity Address, City or Town | Ness Ziona |
Entity Address, Postal Zip Code | 7403650 |
Entity Address, Country | IL |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 15,618 | $ 12,448 |
Bank deposits | 13,500 | 12,500 |
Marketable securities | 17,863 | 8,678 |
Receivables from collaborative and licensing arrangements | 2,205 | 7,858 |
Prepaid expenses and other current assets | 2,405 | 1,571 |
TOTAL CURRENT ASSETS | 51,591 | 43,055 |
NON-CURRENT ASSETS: | ||
Restricted long-term deposits and cash | 1,293 | 1,288 |
Property and equipment, net | 569 | 660 |
Operating lease right-of-use assets | 709 | 876 |
Other long-term receivables | 229 | 0 |
Funds in respect of employee rights upon retirement | 712 | 749 |
TOTAL NON-CURRENT ASSETS | 3,512 | 3,573 |
TOTAL ASSETS | 55,103 | 46,628 |
CURRENT LIABILITIES: | ||
Accounts payable | 461 | 251 |
Other accounts payable | 4,773 | 2,360 |
Current maturities of operating leases | 433 | 718 |
TOTAL CURRENT LIABILITIES | 5,667 | 3,329 |
LONG-TERM LIABILITIES | ||
Operating leases liabilities | 136 | 54 |
Liability for employee rights upon retirement | 1,004 | 1,032 |
TOTAL LONG-TERM LIABILITIES | 1,140 | 1,086 |
TOTAL LIABILITIES | 6,807 | 4,415 |
SHAREHOLDERS' EQUITY: | ||
Ordinary Shares, NIS 0.1 par value – authorized: 50,000,000 as of December 31, 2022 and June 30, 2023; issued and outstanding: 23,129,469 and 27,805,954 as of December 31, 2022 and June 30, 2023, respectively. | 771 | 638 |
Additional paid-in capital | 257,281 | 234,640 |
Accumulated deficit | (209,756) | (193,065) |
TOTAL SHAREHOLDERS' EQUITY | 48,296 | 42,213 |
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ 55,103 | $ 46,628 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (Parenthetical) - ₪ / shares | Jun. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Ordinary shares, par value | ₪ 0.1 | ₪ 0.1 |
Ordinary shares, shares authorized | 50,000,000 | 50,000,000 |
Ordinary shares, shares issued | 27,805,954 | 23,129,469 |
Ordinary shares, shares outstanding | 27,805,954 | 23,129,469 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
LICENSE REVENUES | $ 594 | $ 3,518 | $ 894 | $ 3,521 |
RESEARCH AND DEVELOPMENT EXPENSES | 5,312 | 2,380 | 14,698 | 6,422 |
GENERAL AND ADMINISTRATIVE EXPENSES | 1,809 | 1,601 | 3,786 | 3,512 |
OPERATING LOSS | 6,527 | 463 | 17,590 | 6,413 |
FINANCIAL INCOME, net | (557) | (329) | (899) | (682) |
LOSS FOR THE PERIOD | $ 5,970 | $ 134 | $ 16,691 | $ 5,731 |
BASIC LOSS PER ORDINARY SHARE | $ 0.22 | $ 0.01 | $ 0.63 | $ 0.25 |
DILUTED LOSS PER ORDINARY SHARE | $ 0.22 | $ 0.01 | $ 0.63 | $ 0.25 |
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF BASIC LOSS PER SHARE | 27,660,326 | 23,128,429 | 26,306,484 | 23,127,958 |
WEIGHTED AVERAGE NUMBER OF SHARES OUTSTANDING USED IN COMPUTATION OF DILUTED LOSS PER SHARE | 27,660,326 | 23,128,429 | 26,306,484 | 23,127,958 |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY (Unaudited) - USD ($) $ in Thousands | Ordinary shares [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] | Total | |
Balance at Dec. 31, 2021 | $ 638 | $ 233,098 | $ (178,142) | $ 55,594 | |
Balance, shares at Dec. 31, 2021 | 23,126,804 | ||||
Loss for the period | (5,731) | (5,731) | |||
Exercise of options | [1] | 15 | 15 | ||
Exercise of options, shares | 2,665 | ||||
Share-based compensation | 473 | 473 | |||
Balance at Jun. 30, 2022 | $ 638 | 233,586 | (183,873) | 50,351 | |
Balance, shares at Jun. 30, 2022 | 23,129,469 | ||||
Balance at Mar. 31, 2022 | $ 638 | 233,224 | (183,739) | 50,123 | |
Balance, shares at Mar. 31, 2022 | 23,127,669 | ||||
Loss for the period | (134) | (134) | |||
Exercise of options | [1] | 10 | 10 | ||
Exercise of options, shares | 1,800 | ||||
Share-based compensation | 352 | 352 | |||
Balance at Jun. 30, 2022 | $ 638 | 233,586 | (183,873) | 50,351 | |
Balance, shares at Jun. 30, 2022 | 23,129,469 | ||||
Balance at Dec. 31, 2022 | $ 638 | 234,640 | (193,065) | $ 42,213 | |
Balance, shares at Dec. 31, 2022 | 23,129,469 | 23,129,469 | |||
Loss for the period | (16,691) | $ (16,691) | |||
Issuance of shares and warrants through public offering, net of issuance costs | $ 74 | 11,468 | 11,542 | ||
Issuance of shares and warrants through public offering, net of issuance costs Shares | 2,560,000 | ||||
Issuance of shares and warrants through private placement from the controlling shareholder | $ 56 | 9,944 | 10,000 | ||
Issuance of shares and warrants through private placement from the controlling shareholder Shares | 2,000,000 | ||||
Exercise of options | $ 3 | 177 | 180 | ||
Exercise of options, shares | 116,485 | ||||
Share-based compensation | 1,052 | 1,052 | |||
Balance at Jun. 30, 2023 | $ 771 | 257,281 | (209,756) | $ 48,296 | |
Balance, shares at Jun. 30, 2023 | 27,805,954 | 27,805,954 | |||
Balance at Mar. 31, 2023 | $ 712 | 246,678 | (203,786) | $ 43,604 | |
Balance, shares at Mar. 31, 2023 | 25,702,237 | ||||
Loss for the period | (5,970) | (5,970) | |||
Issuance of shares and warrants through private placement from the controlling shareholder | $ 56 | 9,944 | 10,000 | ||
Issuance of shares and warrants through private placement from the controlling shareholder Shares | 2,000,000 | ||||
Exercise of options | $ 3 | 161 | 164 | ||
Exercise of options, shares | 103,717 | ||||
Share-based compensation | 498 | 498 | |||
Balance at Jun. 30, 2023 | $ 771 | $ 257,281 | $ (209,756) | $ 48,296 | |
Balance, shares at Jun. 30, 2023 | 27,805,954 | 27,805,954 | |||
[1]less than $1 thousand. |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | |||||
Loss for the period | $ (5,970) | $ (134) | $ (16,691) | $ (5,731) | |
Adjustments required to reconcile loss to net cash used in operating activities: | |||||
Depreciation | 185 | 327 | |||
Changes in accrued liability for employee rights upon retirement, net | 9 | 37 | |||
Share-based compensation expenses | 498 | 352 | 1,052 | 473 | |
Financial expenses (income), net | (1) | (126) | |||
Net changes in operating leases | (36) | (173) | |||
Changes in fair value of marketable securities | (66) | 135 | |||
Changes in operating asset and liabilities: | |||||
Receivables from collaborative and licensing arrangements (including long-term) | 5,653 | 7,792 | |||
Prepaid expenses, other current assets and other long-term receivables | (1,063) | (891) | |||
Accounts payable, accrued expenses and other | 2,623 | (8,387) | |||
Net cash used in operating activities | (8,335) | (6,544) | |||
CASH FLOWS FROM INVESTING ACTIVITIES: | |||||
Purchase of property and equipment | (94) | (102) | |||
Investment in marketable securities | (17,114) | (10,006) | $ (10,006) | ||
Proceeds from sales and maturity of marketable securities | 7,995 | 1,734 | 2,918 | ||
Short-term deposits | (1,000) | 448 | |||
Restricted long-term deposits | 12 | 9 | |||
Net cash used in investing activities | (10,201) | (7,917) | |||
CASH FLOWS FROM FINANCING ACTIVITIES: | |||||
Proceeds from exercise of options | 180 | 15 | |||
Proceeds from issuance of shares and warrants through placement from the controlling shareholder | 10,000 | 0 | |||
Proceeds from issuance of shares and warrants through public offering, net of issuance costs | 11,542 | 0 | |||
Net cash provided by financing activities | 21,722 | 15 | |||
EFFECT OF EXCHANGE RATE ON CASH AND CASH EQUIVALENTS | 1 | 126 | |||
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS AND RESTRICTED CASH | 3,187 | (14,320) | |||
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AT BEGINNING OF THE PERIOD | 13,598 | 21,235 | 21,235 | ||
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH AT END OF THE PERIODS | 16,785 | 6,915 | 16,785 | 6,915 | 13,598 |
Cash and Cash equivalents | 15,618 | 5,765 | 15,618 | 5,765 | 12,448 |
Restricted cash | 1,167 | 1,150 | 1,167 | 1,150 | |
CASH AND CASH EQUIVALENTS AND RESTRICTED CASH SHOWN IN STATEMENT OF CASH FLOWS | $ 16,785 | $ 6,915 | 16,785 | 6,915 | $ 13,598 |
SUPPLEMENTARY INFORMATION ON INVESTING AND FINANCING ACTIVITIES NOT INVOLVING CASH FLOWS: | |||||
Recognition of new operating lease ROU and liabilities | 190 | 88 | |||
SUPPLEMENTARY INFORMATION: | |||||
Interest received | $ 590 | $ 153 |
NATURE OF OPERATIONS
NATURE OF OPERATIONS | 6 Months Ended |
Jun. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
NATURE OF OPERATIONS | 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 has two approved drugs: (i) Twyneo®, which was developed for the treatment of acne vulgaris and received marketing authorization by the U.S. Food and Durg Administration (the "FDA") on July 27, 2021 and (ii) Epsolay®, a treatment for subtype II rosacea that received marketing authorization by the FDA on April 25, 2022. In June 2021, the Company entered into two exclusive license agreements with Galderma for the commercialization of Twyneo® and Epsolay®, in the United States, see note 5. On April 14, 2022, the Company announced that Twyneo® is available for purchase by consumers who obtain a prescription from their physician. On June 2, 2022, the Company announced that Epsolay® is available for purchase by consumers who obtain a prescription from their physician. In addition to the novel products, the Company’s products included the approved generic products Acyclovir, Ivermectin and other generic product candidates. In November 2021, the Company entered into an agreement with Padagis, to sell its rights in relation to ten generic collaborative agreements between the parties, including the agreements for the two aforementioned approved generic drug products. Under the new agreement, the Company has retained collaboration rights to two generic programs related to four generic drug candidates, see note 4b. On January 27, 2023 the Company entered into an asset purchase agreement with PellePharm, Inc. (hereafter-“PellePharm”), pursuant to which the Company agreed to purchase all of the assets related to the topically-applied patidegib, a hedgehog signaling pathway blocker, for the treatment of Gorlin syndrome (such compound designated as investigational compound SGT-610). On January 30, 2023, upon closing of the transaction, the Company was required to pay an upfront payment (hereafter- "upfront payment") of $4.7 million to PellePharm. The upfront payment is paid as follows: (i) $4 million was paid upon closing and (ii) $0.7 million will be paid, subject to the terms as defined in the Agreement, 15 months from the closing date. In addition, the Company will be required to pay total development and NDA acceptance milestones of up to $6 million, and up to $64 million in commercial milestones which amount increases to $89 million when sales exceed $500 million as well as single digit royalties which increase to double digit royalties when sales exceed $500 million. The upfront payment and the additional development milestone payments under the PellePharm agreement represent payments for research and development in-process ("IPR&D") acquired as part of an asset purchase, which has not reached technological feasibility and has no alternative future use. Accordingly, such payments are expensed as incurred and are recognized as research and development expenses. The Company has a wholly owned U.S. subsidiary - Sol-Gel Technologies Inc. (the "Subsidiary"). The Subsidiary supports the Company with regard to marketing, regulatory affairs and business development relating to its products and technology in the U.S. Risk and Uncertainties Since incorporation through June 30, 2023, the Company has an accumulated deficit of $209,756 and its activities have been funded mainly by its shareholders, collaboration revenues and license agreements, 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 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. Management expects that the Company's cash and cash equivalents, deposits and marketable securities as of June 30, 2023 will allow the Company to fund its operating plan through at least the next 12 months from the condensed financial statement issuance date. See also note 8 with regards to cost-saving measures, management adopted subsequent to June 30, 2023. |
SIGNIFICANT ACCOUNTING POLICIES
SIGNIFICANT ACCOUNTING POLICIES: | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES: | NOTE 2 – SIGNIFICANT ACCOUNTING POLICIES: a. Basis of Presentation The consolidated results for the six month period ended June 30, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023. 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, 2022. The comparative balance sheet at December 31, 2022 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 The calculation of diluted loss per share does not include 5,961,999 and 7,120,463 options and warrants for the six and three months ended June 30, 2023 and 3,713,296 and 4,085,416 options and warrants for the six and the three months ended June 30, 2022, respectively, because the effect would be anti-dilutive. |
MARKETABLE SECURITIES_
MARKETABLE SECURITIES: | 6 Months Ended |
Jun. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
MARKETABLE SECURITIES | NOTE 3 – MARKETABLE SECURITIES: The following table sets forth the Company’s marketable securities for the indicated periods: December 31, June 30, 2022 2023 Level 2 securities: U.S government and agency bonds 1,494 - Other foreign government bonds - 3,899 Corporate bonds* 7,184 13,964 Total 8,678 17,863 * Investments in Corporate bonds rated A or higher. The Company elected the fair value option to measure and recognize its investments in debt securities in accordance with ASC 825, Financial Instruments as the Company manages its portfolio and evaluates the performance on a fair value basis. 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, 2022 For the Six Months ended June 30, 2023 Balance at beginning of the period 1,709 8,678 Additions 10,006 17,114 Sale or maturity (2,918 ) (7,995 ) Changes in fair value during the period (119 ) 66 Balance at end of the period 8,678 17,863 As of June 30, 2023, the Company’s debt securities had the following maturity dates: Market value June 30, 2023 Due within one year 7,445 Between 1-2 years 10,418 The carrying amount of the cash and cash equivalents, bank deposits, restricted cash, restricted long term deposits, receivables from collaborative arrangements, accrued expenses and other liabilities approximates their fair value. |
COLLABORATION AGREEMENTS_
COLLABORATION AGREEMENTS: | 6 Months Ended |
Jun. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
COLLABORATION AGREEMENTS: | 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 2020, the Company entered into several collaboration agreements mainly with one partner (the "Partner") for the development, manufacturing and commercialization of several generic product candidates. Under the agreements, the Partner is 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 Partner has exclusive rights and is 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 a share of the Partner's gross profits related to the sale of the products, as such term is defined in each of the agreements. These 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. In November 2021, the Company entered into a new agreement (the "New Agreement") with the Partner, to sell its rights in relation to ten generic collaborative agreements between the parties, including the agreements for two approved generic drug products. Under the New Agreement, the Company has retained collaboration rights to two generic programs related to four generic drug candidates. Following the signing of the New Agreement, the Company is no longer entitled to receive its share in profit as detailed above, other than with respect to the two generic drug programs related to four generic products. Under the terms of the New Agreement, effective as of November 1, 2021, the Company will unconditionally receive $21,500 over 24 months, in lieu of its share in future gross profits for the two approved generic drug products and its potential gross profits for eight unapproved generic programs. The Company received $1,250 as an upfront payment and $20,250 in eight equal quarterly instalments. The New Agreement also provides that effective as of November 1, 2021, the Company will cease paying any outstanding and future operational costs related to these collaborative agreements. |
LICENSE AGREEMENTS_
LICENSE AGREEMENTS: | 6 Months Ended |
Jun. 30, 2023 | |
License Agreements [Abstract] | |
LICENSE AGREEMENTS: | NOTE 5 – LICENSE AGREEMENTS: a. In June 2021, the Company entered into two exclusive license agreements with Galderma for the commercialization of Twyneo® and Epsolay® in the United States. Following the FDA approvals for each of the products and under the license agreements, the Company received $7.5 million for Twyneo® and $3.5 million for Epsolay® as regulatory approval milestone payments. 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. On April 14, 2022, the Company announced that Twyneo® is available for purchase by consumers who obtain a prescription from their physician, See note 1. On June 2, 2022, the Company announced that Epsolay® is available for purchase by consumers who obtain a prescription from their physician, See also note 1. b. On June 6, 2023, the Company and Searchlight Pharma Inc. (“Searchlight”), a private Canadian specialty pharmaceutical company, signed on an exclusive license agreements for TWYNEO and EPSOLAY for the Canadian market, over a fifteen-year term that is renewable for subsequent five-year periods. Searchlight will be responsible for obtaining and maintaining any regulatory approvals required to market and sell the drugs in Canada, with support from the Company. Under the agreement, the Company will receive up to $11 million in potential upfront payments and regulatory and sales milestones for both drugs, combined. In addition, the Company will be entitled to royalty percentages of all Canadian net sales ranging from low-double-digits to high teens. In June 2023, the Company received $500 as an upfront payment in connection with the license agreement and related support provided to Searchlight for obtaining the regulatory approval in the Canadian market. The Company is also required to support Searchlight during such period if needed based on agreed upon rates. The Company has identified two performance obligations in the license agreement as follows: (i) the license to market the products in Canada; and (ii) continuing support during the regulatory approval process. Accordingly, the Company recognized $380 as license revenue in the period and recorded $120 as contract liability in respect of the support services. |
SHARE CAPITAL_
SHARE CAPITAL: | 6 Months Ended |
Jun. 30, 2023 | |
Stockholders' Equity Note [Abstract] | |
SHARE CAPITAL: | NOTE 6 – SHARE CAPITAL: a. Ordinary shares On January 27, 2023, the Company entered into a securities purchase agreement (hereafter - “Purchase Agreement”) with Armistice Capital, pursuant to which the Company issued to Armistice Capital (i) 2,560,000 ordinary shares of the Company, par value NIS 0.1 per share in a registered direct offering at a price of $5.00 per ordinary share and (ii) in a concurrent private placement unregistered warrants to purchase up to 2,560,000 Ordinary Shares (the "Investor Warrants"). Each of the Investor Warrants are exercisable for one ordinary share, have an exercise price of $5.85 and will become exercisable beginning six months from the date of issuance and will expire on January 27, 2028. The sale of the Ordinary Shares in the Registered Direct Offering was made by means of a shelf registration statement. The Offering closed on January 31, 2023. The gross proceeds from the Offering were approximately $12.8 million. Concurrently with the signing of the Purchase Agreement, the Company also entered into a subscription agreement (hereafter - “Subscription Agreement”) between the Company and M. Arkin Dermatology Ltd., the Controlling Shareholder of the Company, pursuant to which M. Arkin Dermatology Ltd. agreed to purchase 2,000,000 unregistered Ordinary Shares and unregistered warrants to purchase up to 2,000,000 ordinary shares (the “PIPE Warrants” and, together with the Investor Warrants, the “Warrants”) in a concurrent private placement (hereafter- “Affiliate Private Placement"), at a price equal to the offering price of the Ordinary Shares in the Offering. The Affiliate Private Placement agreement was contingent on certain conditions and was approved by the Company’s shareholders on March, 2023. The total proceeds of $10,000 were received in April 2023. b. Options grants 1) During the Six months ended June 30, 2023, the Company granted 749,750 options to employees and executive officers: i. In March 2023, the Company granted a total of 53,092 options to several employees to purchase ordinary shares at an exercise price of $4.63 and $5.6 per share. 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 March 2023, the Company granted a total of 439,314 options to several Executive Officers to purchase ordinary shares at an exercise price of $5.6 per share. 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. iii. In March 2023, the board of directors approved and recommended the Company's shareholders to approve a grant of 257,344 options to the Company's CEO to purchase ordinary shares at an exercise price of $5.6 per share. The Company's shareholders approved the grant in July 2023. 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. The weighted average fair value of options granted in 2023 was $2.01 The underlying data used for computing the fair value of the options are as follows: 2023 Value of one ordinary share $ 3.8 Dividend yield 0 % Expected volatility 56 % Risk-free interest rate 4.1 % Expected term 7 years c. Option plan In March 2023, the Company’s Board of Directors approved an increase of the ordinary shares that may be issued under the Company’s Plan by reserving an additional amount of 1,250,000 ordinary shares. |
RELATED PARTIES_
RELATED PARTIES: | 6 Months Ended |
Jun. 30, 2023 | |
Related Party Transactions [Abstract] | |
RELATED PARTIES: | NOTE 7 – 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 options and restricted shares granted to directors and executive officers, see note 6. |
SUBSEQUENT EVENTS_
SUBSEQUENT EVENTS: | 6 Months Ended |
Jun. 30, 2023 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS: | NOTE 8 – SUBSEQUENT EVENT: On August 10, 2023, following recent assessment of partner licensing revenues and the delay in the development of SGT-210, the Company announced a restructuring plan to reduce operating expenses as part of cost-saving measures. The Plan’s cost-saving measures includes workforce reductions of about 25 employees, as well as other cost-mitigation measures. |
SIGNIFICANT ACCOUNTING POLICI_2
SIGNIFICANT ACCOUNTING POLICIES: (Policies) | 6 Months Ended |
Jun. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | a. Basis of Presentation The consolidated results for the six month period ended June 30, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023. 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, 2022. The comparative balance sheet at December 31, 2022 has been derived from the audited financial statements at that date but does not include all disclosures required by U.S. GAAP. |
Loss per share | b. Loss per share The calculation of diluted loss per share does not include 5,961,999 and 7,120,463 options and warrants for the six and three months ended June 30, 2023 and 3,713,296 and 4,085,416 options and warrants for the six and the three months ended June 30, 2022, respectively, because the effect would be anti-dilutive. |
MARKETABLE SECURITIES_ (Tables)
MARKETABLE SECURITIES: (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of Marketable Securities | December 31, June 30, 2022 2023 Level 2 securities: U.S government and agency bonds 1,494 - Other foreign government bonds - 3,899 Corporate bonds* 7,184 13,964 Total 8,678 17,863 * Investments in Corporate bonds rated A or higher. |
Schedule Of Summary of Changes in Fair Value of Marketable Securities | Marketable securities For the year ended December 31, 2022 For the Six Months ended June 30, 2023 Balance at beginning of the period 1,709 8,678 Additions 10,006 17,114 Sale or maturity (2,918 ) (7,995 ) Changes in fair value during the period (119 ) 66 Balance at end of the period 8,678 17,863 |
Schedule of Debt Securities | Market value June 30, 2023 Due within one year 7,445 Between 1-2 years 10,418 |
SHARE CAPITAL_ (Tables)
SHARE CAPITAL: (Tables) | 6 Months Ended |
Jun. 30, 2023 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Assumptions Used to Estimate Fair Value | 2023 Value of one ordinary share $ 3.8 Dividend yield 0 % Expected volatility 56 % Risk-free interest rate 4.1 % Expected term 7 years |
NATURE OF OPERATIONS (Narrative
NATURE OF OPERATIONS (Narrative) (Details) - USD ($) $ in Thousands | 1 Months Ended | |||
Jan. 30, 2023 | Jun. 30, 2023 | Dec. 31, 2022 | Jun. 30, 2022 | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Accumulated deficit | $ (209,756) | $ (193,065) | $ (209,756) | |
PellePharm, Inc. [Member] | Asset Purchase Agreement [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Upfront payment paid | $ 4,700 | |||
PellePharm, Inc. [Member] | Asset Purchase Agreement [Member] | Development And Nda Acceptance Milestones [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Sales milestone payments | 6,000 | |||
PellePharm, Inc. [Member] | Asset Purchase Agreement [Member] | Commercial Milestones [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Sales milestone payments | $ 64,000 | |||
Description of upfront payment | (i) $4 million was paid upon closing and (ii) $0.7 million will be paid, subject to the terms as defined in the Agreement, 15 months from the closing date. | |||
Increase in sales milestone amount due to sales exceed dollar 500 million | $ 89,000 |
SIGNIFICANT ACCOUNTING POLICI_3
SIGNIFICANT ACCOUNTING POLICIES: (Narrative) (Details) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2023 | Jun. 30, 2022 | Jun. 30, 2023 | Jun. 30, 2022 | |
Accounting Policies [Abstract] | ||||
Anti-dilutive shares | 7,120,463 | 4,085,416 | 5,961,999 | 3,713,296 |
MARKETABLE SECURITIES_ (Schedul
MARKETABLE SECURITIES: (Schedule of Company's Marketable Securities) (Details) - USD ($) $ in Thousands | Jun. 30, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Level 2 securities: | ||||
Marketable securities | $ 17,863 | $ 8,678 | $ 1,709 | |
U.S government and agency bonds [Member] | ||||
Level 2 securities: | ||||
Marketable securities | 0 | 1,494 | ||
Other foreign government bonds [Member] | ||||
Level 2 securities: | ||||
Marketable securities | 3,899 | 0 | ||
Corporate bonds [Member] | ||||
Level 2 securities: | ||||
Marketable securities | [1] | $ 13,964 | $ 7,184 | |
[1]Investments in Corporate bonds rated A or higher. |
MARKETABLE SECURITIES_ (Sched_2
MARKETABLE SECURITIES: (Schedule of Changes in Fair Value of Company's Marketable Securities) (Details) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2023 | Jun. 30, 2022 | Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |||
Balance at beginning of the period | $ 8,678 | $ 1,709 | $ 1,709 |
Additions | 17,114 | 10,006 | 10,006 |
Sale or maturity | (7,995) | $ (1,734) | (2,918) |
Changes in fair value during the period | 66 | (119) | |
Balance at end of the period | $ 17,863 | $ 8,678 |
MARKETABLE SECURITIES_ (Sched_3
MARKETABLE SECURITIES: (Schedule of Company's debt marketable securities) (Details) $ in Thousands | Jun. 30, 2023 USD ($) |
Investments, Debt and Equity Securities [Abstract] | |
Due within one year | $ 7,445 |
Between 1-2 years | $ 10,418 |
COLLABORATION AGREEMENTS_ (Narr
COLLABORATION AGREEMENTS: (Narrative) (Details) $ in Thousands | 12 Months Ended | |
Nov. 01, 2021 USD ($) Agreement Candidate Instalment Program | Dec. 31, 2007 | |
Number of generic collaborative agreements to sell rights | Agreement | 10 | |
Number of generic programs retained for collaboration rights | Program | 2 | |
Number of generic drug candidates | Candidate | 4 | |
Expected revenue receivable over twenty four months | $ | $ 21,500 | |
Number of approved generic drug products | Program | 2 | |
Number of unapproved generic programs | Program | 8 | |
Upfront payment received | $ | $ 1,250 | |
Payment receivable in instalments | $ | $ 20,250 | |
Number of equal quarterly instalments | Instalment | 8 | |
Minimum [Member] | ||
Royalties maturity | 2016 | |
Maximum [Member] | ||
Royalties maturity | 2024 |
LICENSE AGREEMENTS_ (Narrative)
LICENSE AGREEMENTS: (Narrative) (Details) - USD ($) $ in Thousands | 1 Months Ended | 6 Months Ended | ||
Jun. 06, 2023 | Jun. 30, 2021 | Jun. 30, 2023 | Jun. 30, 2022 | |
Twyneo [Member] | License Agreements With Galderma [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Regulatory approval milestone payments received | $ 7,500 | |||
Epsolay [Member] | License Agreements With Galderma [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Regulatory approval milestone payments received | 3,500 | |||
Twyneo And Epsolay [Member] | License Agreements With Galderma [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Sales milestone payments | $ 9,000 | |||
Royalties revenues | $ 466 | $ 3,500 | ||
Twyneo And Epsolay [Member] | License Agreements With Searchlight [Member] | ||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||
Upfront payments received | $ 11,000 | 500 | ||
Royalties revenues | 380 | |||
Contract liability | $ 120 |
SHARE CAPITAL_ (Narrative) (Det
SHARE CAPITAL: (Narrative) (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 6 Months Ended | 12 Months Ended | ||||||||
Apr. 30, 2023 USD ($) | Mar. 31, 2023 shares | Jan. 27, 2023 USD ($) shares | Mar. 31, 2022 $ / shares shares | Jun. 30, 2023 USD ($) $ / shares shares | Jun. 30, 2022 USD ($) | Dec. 31, 2022 ₪ / shares | Jun. 30, 2023 ₪ / shares | Jun. 30, 2023 $ / shares | Jan. 27, 2023 ₪ / shares shares | Jan. 27, 2023 $ / shares shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Par value | ₪ / shares | ₪ 0.1 | ₪ 0.1 | |||||||||
Expected term | 7 years | ||||||||||
Proceeds from Issuance Initial Public Offering | $ | $ 11,542 | $ 0 | |||||||||
Proceeds from Issuance of Private Placement | $ | $ 10,000 | $ 0 | |||||||||
Odinary share issued under share incentive plan | 1,250,000 | ||||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ / shares | $ 2.01 | ||||||||||
Purchase Agreement With Armistice Capital [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Shares issued | 2,560,000 | ||||||||||
Par value | ₪ / shares | ₪ 0.1 | ||||||||||
Per share price | $ / shares | $ 5 | ||||||||||
Purchase Agreement With Armistice Capital [Member] | Investor Warrants [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Exercise price | $ / shares | $ 5.85 | ||||||||||
Warrants to purchase ordinary shares | 2,560,000 | 2,560,000 | |||||||||
Net proceeds | $ | $ 12,800 | ||||||||||
Subscription Agreement M Arkin Dermatology Ltd [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Shares issued | 2,000,000 | ||||||||||
Warrants to purchase ordinary shares | 2,000,000 | 2,000,000 | |||||||||
Net proceeds | $ | $ 10,000 | ||||||||||
Employees [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Option grants | 53,092 | 749,750 | |||||||||
Exercise price | $ / shares | $ 4.63 | $ 5.6 | |||||||||
Option vesting period | 4 years | ||||||||||
Executive Officers [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Option grants | 439,314 | ||||||||||
Exercise price | $ / shares | $ 5.6 | ||||||||||
Option vesting period | 4 years | ||||||||||
Chief Executive Officer [Member] | |||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||||||
Option grants | 257,344 | ||||||||||
Exercise price | $ / shares | $ 5.6 | ||||||||||
Option vesting period | 4 years |
SHARE CAPITAL_ (Schedule of Ass
SHARE CAPITAL: (Schedule of Assumptions Used to Estimate Fair Value) (Details) | 12 Months Ended |
Dec. 31, 2022 $ / shares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Value of one ordinary share | $ 3.8 |
Dividend yield | 0% |
Expected volatility | 56% |
Risk-free interest rate | 4.10% |
Expected term | 7 years |