Document And Entity Information
Document And Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 09, 2023 | |
Document Information Line Items | ||
Entity Registrant Name | ORAMED PHARMACEUTICALS INC. | |
Trading Symbol | ORMP | |
Document Type | 10-Q | |
Current Fiscal Year End Date | --12-31 | |
Entity Common Stock, Shares Outstanding | 40,338,979 | |
Amendment Flag | false | |
Entity Central Index Key | 0001176309 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity File Number | 001-35813 | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 98-0376008 | |
Entity Address, Address Line One | 1185 Avenue of the Americas | |
Entity Address, Address Line Two | Third Floor | |
Entity Address, City or Town | New York | |
Entity Address, State or Province | NY | |
Entity Address, Postal Zip Code | 10036 | |
City Area Code | 844 | |
Local Phone Number | 967-2633 | |
Title of 12(b) Security | Common Stock, par value $0.012 | |
Security Exchange Name | NASDAQ | |
Entity Interactive Data Current | Yes |
Interim Condensed Consolidated
Interim Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 5,468 | $ 40,464 |
Short-term deposits | 120,158 | 111,513 |
Marketable securities | 3,743 | |
Investments at fair value | 49,413 | |
Prepaid expenses and other current assets | 666 | 1,389 |
Total current assets | 175,705 | 157,109 |
LONG-TERM ASSETS: | ||
Long-term deposits | 6 | 7 |
Investments at fair value | 47,406 | |
Marketable securities | 2,535 | |
Non-marketable equity securities | 3,524 | 2,700 |
Amounts funded in respect of employee rights upon retirement | 26 | 24 |
Property and equipment, net | 923 | 815 |
Operating lease right-of-use assets | 768 | 987 |
Total long-term assets | 55,188 | 4,533 |
Total assets | 230,893 | 161,642 |
CURRENT LIABILITIES: | ||
Accounts payable and accrued expenses | 2,561 | 4,158 |
Short-term borrowings | 75,363 | |
Deferred revenues | 1,340 | |
Payable to related parties | 1 | |
Operating lease liabilities | 251 | 247 |
Total current liabilities | 78,175 | 5,746 |
LONG-TERM LIABILITIES: | ||
Long-term deferred revenues | 4,000 | 4,000 |
Employee rights upon retirement | 27 | 21 |
Provision for uncertain tax position | 11 | 11 |
Operating lease liabilities | 389 | 647 |
Other liabilities | 61 | 61 |
Total long-term liabilities | 4,488 | 4,740 |
COMMITMENTS (note 3) | ||
EQUITY ATTRIBUTABLE TO COMPANY’S STOCKHOLDERS: | ||
Common stock, $0.012 par value (60,000,000 authorized shares; 40,282,688 and 39,563,888 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively) | 484 | 476 |
Additional paid-in capital | 319,540 | 314,417 |
Accumulated deficit | (170,892) | (163,081) |
Total stockholders’ equity | 149,132 | 151,812 |
Non-controlling interests | (902) | (656) |
Total equity | 148,230 | 151,156 |
Total liabilities and equity | $ 230,893 | $ 161,642 |
Interim Condensed Consolidate_2
Interim Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in Dollars per share) | $ 0.012 | $ 0.012 |
Common stock, shares authorized | 60,000,000 | 60,000,000 |
Common stock, shares issued | 40,282,688 | 39,563,888 |
Common stock, shares outstanding | 40,282,688 | 39,563,888 |
Interim Condensed Consolidate_3
Interim Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Statement [Abstract] | ||||
REVENUES | $ 682 | $ 1,340 | $ 2,022 | |
RESEARCH AND DEVELOPMENT EXPENSES | 957 | 5,347 | 7,205 | 20,362 |
SALES AND MARKETING EXPENSES | (663) | 463 | (287) | 1,433 |
GENERAL AND ADMINISTRATIVE EXPENSES | 2,599 | 3,061 | 6,314 | 11,085 |
OPERATING LOSS | 2,893 | 8,189 | 11,892 | 30,858 |
INTEREST EXPENSES | 826 | 826 | ||
FINANCIAL INCOME, NET | 435 | 1,036 | 4,510 | 1,930 |
LOSS BEFORE TAX EXPENSES | 3,284 | 7,153 | 8,208 | 28,928 |
TAX EXPENSES | 100 | 100 | ||
NET LOSS | 3,284 | 7,253 | 8,208 | 29,028 |
NET LOSS ATTRIBUTABLE TO NON-CONTROLLING INTERESTS | 62 | 193 | 397 | 1,010 |
NET LOSS ATTRIBUTABLE TO STOCKHOLDERS | $ 3,222 | $ 7,060 | $ 7,811 | $ 28,018 |
BASIC LOSS PER SHARE OF COMMON STOCK (in Dollars per share) | $ 0.08 | $ 0.18 | $ 0.19 | $ 0.72 |
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING BASIC LOSS PER SHARE OF COMMON STOCK (in Shares) | 40,445,896 | 39,100,231 | 40,246,515 | 38,856,514 |
Interim Condensed Consolidate_4
Interim Condensed Consolidated Statements of Comprehensive Loss (Unaudited) (Parentheticals) - $ / shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Statement [Abstract] | ||||
DILUTED LOSS PER SHARE OF COMMON STOCK | $ 0.08 | $ 0.18 | $ 0.19 | $ 0.72 |
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING DILUTED LOSS PER SHARE OF COMMON STOCK (in Shares) | 40,445,896 | 39,100,231 | 40,246,515 | 38,856,514 |
Interim Condensed Consolidate_5
Interim Condensed Consolidated Statements of Changes in Stockholders’ Equity (Unaudited) - USD ($) $ in Thousands | Common Stock | Additional paid-in capital | Accumulated deficit | Total stockholders’ equity | Non- controlling interests | Total | |
BALANCE at Dec. 31, 2021 | $ 459 | $ 292,514 | $ (126,520) | $ 166,453 | $ 157 | $ 166,610 | |
BALANCE (in Shares) at Dec. 31, 2021 | 38,158 | ||||||
ISSUANCE OF COMMON STOCK, NET | $ 9 | 7,336 | 7,345 | 7,345 | |||
ISSUANCE OF COMMON STOCK, NET (in Shares) | 770 | ||||||
EXERCISE OF WARRANTS AND OPTIONS | [1] | 42 | 42 | 42 | |||
EXERCISE OF WARRANTS AND OPTIONS (in Shares) | 34 | ||||||
STOCK-BASED COMPENSATION | $ 2 | 8,767 | 8,769 | 8,769 | |||
STOCK-BASED COMPENSATION (in Shares) | 151 | ||||||
STOCK-BASED COMPENSATION OF SUBSIDIARY | 192 | 192 | |||||
TAX WITHHOLDINGS RELATED TO STOCK-BASED COMPENSATION SETTLEMENTS | (783) | (783) | (783) | ||||
NET (INCOME) LOSS | (28,018) | (28,018) | (1,010) | (29,028) | |||
BALANCE at Sep. 30, 2022 | $ 470 | 307,876 | (154,538) | 153,808 | (661) | 153,147 | |
BALANCE (in Shares) at Sep. 30, 2022 | 39,113 | ||||||
BALANCE at Jun. 30, 2022 | $ 463 | 300,712 | (147,478) | 153,697 | (660) | 153,037 | |
BALANCE (in Shares) at Jun. 30, 2022 | 38,564 | ||||||
ISSUANCE OF COMMON STOCK, NET | $ 6 | 4,371 | 4,377 | 4,377 | |||
ISSUANCE OF COMMON STOCK, NET (in Shares) | 493 | ||||||
EXERCISE OF WARRANTS AND OPTIONS | [1] | 42 | 42 | 42 | |||
EXERCISE OF WARRANTS AND OPTIONS (in Shares) | 30 | ||||||
STOCK-BASED COMPENSATION | $ 1 | 2,857 | 2,858 | 2,858 | |||
STOCK-BASED COMPENSATION (in Shares) | 26 | ||||||
STOCK-BASED COMPENSATION OF SUBSIDIARY | 192 | 192 | |||||
TAX WITHHOLDINGS RELATED TO STOCK-BASED COMPENSATION SETTLEMENTS | (106) | (106) | (106) | ||||
NET (INCOME) LOSS | (7,060) | (7,060) | (193) | (7,253) | |||
BALANCE at Sep. 30, 2022 | $ 470 | 307,876 | (154,538) | 153,808 | (661) | 153,147 | |
BALANCE (in Shares) at Sep. 30, 2022 | 39,113 | ||||||
BALANCE at Dec. 31, 2022 | $ 476 | 314,417 | (163,081) | 151,812 | (656) | $ 151,156 | |
BALANCE (in Shares) at Dec. 31, 2022 | 39,564 | 39,563,888 | |||||
ISSUANCE OF COMMON STOCK, NET | $ 2 | 2,426 | 2,428 | $ 2,428 | |||
ISSUANCE OF COMMON STOCK, NET (in Shares) | 193 | ||||||
SHARES ISSUED FOR SERVICES | [1] | 9 | 9 | 9 | |||
SHARES ISSUED FOR SERVICES (in Shares) | 3 | ||||||
STOCK-BASED COMPENSATION | $ 6 | 2,688 | 2,694 | 2,694 | |||
STOCK-BASED COMPENSATION (in Shares) | 523 | ||||||
STOCK-BASED COMPENSATION OF SUBSIDIARY | 151 | 151 | |||||
NET (INCOME) LOSS | (7,811) | (7,811) | (397) | (8,208) | |||
BALANCE at Sep. 30, 2023 | $ 484 | 319,540 | (170,892) | 149,132 | (902) | $ 148,230 | |
BALANCE (in Shares) at Sep. 30, 2023 | 40,283 | 40,282,688 | |||||
BALANCE at Jun. 30, 2023 | $ 484 | 318,732 | (167,670) | 151,546 | (891) | $ 150,655 | |
BALANCE (in Shares) at Jun. 30, 2023 | 40,219 | ||||||
SHARES ISSUED FOR SERVICES | [1] | 7 | 7 | 7 | |||
SHARES ISSUED FOR SERVICES (in Shares) | 3 | ||||||
STOCK-BASED COMPENSATION | [1] | 801 | 801 | 801 | |||
STOCK-BASED COMPENSATION (in Shares) | 61 | ||||||
STOCK-BASED COMPENSATION OF SUBSIDIARY | 51 | 51 | |||||
NET (INCOME) LOSS | (3,222) | (3,222) | (62) | (3,284) | |||
BALANCE at Sep. 30, 2023 | $ 484 | $ 319,540 | $ (170,892) | $ 149,132 | $ (902) | $ 148,230 | |
BALANCE (in Shares) at Sep. 30, 2023 | 40,283 | 40,282,688 | |||||
[1] Represents an amount of less than $1. |
Interim Condensed Consolidate_6
Interim Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (8,208) | $ (29,028) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 143 | 41 |
Exchange differences and interest on deposits and held to maturity bonds | (2,042) | (933) |
Changes in fair value of investments | (191) | 494 |
Stock-based compensation | 2,845 | 8,961 |
Shares issued for services | 9 | |
Gain on amounts funded in respect of employee rights upon retirement | (2) | |
Accrued interest on short-term borrowings to maturity | 813 | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 726 | 1,034 |
Accounts payable, accrued expenses and related parties | (1,601) | (330) |
Net changes in operating lease | (35) | (105) |
Deferred revenues | (1,340) | (21) |
Liability for employee rights upon retirement | 6 | (1) |
Other liabilities | 32 | |
Total net cash used in operating activities | (8,877) | (19,856) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of short-term deposits | (91,369) | (111,500) |
Proceeds from short-term deposits | 84,760 | 128,000 |
Proceeds from maturity of held to maturity securities | 3,375 | 5,336 |
Long-term investments | (99,550) | (2,700) |
Funds in respect of employee rights upon retirement | 3 | |
Purchase of property and equipment | (251) | (188) |
Total net cash provided by (used in) investing activities | (103,035) | 18,951 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of common stock, net of issuance costs | 2,428 | 7,345 |
Loans received | 99,550 | |
Loans paid | (25,000) | |
Proceeds from exercise of warrants and options | 42 | |
Tax withholdings related to stock-based compensation settlements | (783) | |
Total net cash provided by financing activities | 76,978 | 6,604 |
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS | (62) | 41 |
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | (34,996) | 5,740 |
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 40,464 | 27,456 |
CASH AND CASH EQUIVALENTS AT END OF PERIOD | 5,468 | 33,196 |
(A) SUPPLEMENTARY DISCLOSURE ON CASH FLOWS - | ||
Interest received | 3,393 | 906 |
Interest paid | (14) | |
(B) SUPPLEMENTARY DISCLOSURE ON CASH FLOWS - | ||
Recognition of operating lease right-of-use assets and liabilities | $ 678 |
General
General | 9 Months Ended |
Sep. 30, 2023 | |
General [Abstract] | |
GENERAL | NOTE 1 - GENERAL: a. Incorporation and Operations Oramed Pharmaceuticals Inc. (collectively with its subsidiaries, the “Company”, unless the context indicates otherwise), a Delaware corporation, was incorporated on April 12, 2002. On March 18, 2021, the Company entered into a license agreement (the “Oravax License Agreement”) with Oravax Medical Inc. (“Oravax”) and into a stockholders agreement (the “Stockholders Agreement”) with Akers Biosciences Inc. (“Akers”), Premas Biotech Pvt. Ltd. (“Premas”), Cutter Mill Capital LLC (“Cutter Mill”) and Run Ridge LLC (“Run Ridge”). According to the Stockholders Agreement, Oravax issued 1,890,000 shares of its capital stock to the Company, representing 63% of the issued and outstanding share capital of Oravax as of the date of issuance. Consequently, Oramed consolidates Oravax in its consolidated financial statements since that time. On November 23, 2021, Oravax incorporated a wholly-owned subsidiary in Israel, Oravax Medical Ltd., which is engaged in research and development. Effective January 1, 2022, Oravax transferred its rights and obligations under the Oravax License Agreement to Oravax Medical Ltd. On January 11, 2023, the Company announced that the ORA-D-013-1 Phase 3 trial did not meet its primary and secondary endpoints. As a result, the Company terminated this trial and a parallel Phase 3, ORA-D-013-2 clinical trial. As these results are considered a triggering event, the Company evaluated all of its long lived assets which include fixed assets and operating lease right-of-use assets in the first quarter of 2023 and concluded that no impairment was required. The Company recently completed an analysis of the data from the ORA-D-013-1 Phase 3 trial and found that subpopulations of patients with pooled specific parameters, such as body mass index (BMI), baseline HbA1c, age, gender and body weight, responded well to oral insulin. These subsets exhibited an over 1% placebo adjusted, statistically significant, reduction in HbA1c. The Company is currently considering if there is a path forward for its oral insulin candidate, based on this analysis. Concurrently, the Company is examining its existing pipeline and has commenced an evaluation process of potential strategic opportunities, with the goal of enhancing value for the Company’s stockholders. b. Development and Liquidity Risks The Company is engaged in research and development in the biotechnology field for innovative pharmaceutical solutions, including an orally ingestible insulin capsule to be used for the treatment of individuals with diabetes, and the use of orally ingestible capsules for delivery of other polypeptides, and has not generated significant revenues from its operations. Following the termination of the ORA-D-013-1 and ORA-D-013-2 Phase 3 trials, the Company’s research and development activities have been significantly reduced while it conducts a strategic review process. As a result, the Company is currently incurring lower research and development and sales and marketing expenses. Based on the Company’s current cash resources and commitments, the Company believes it will be able to maintain its current planned activities and the corresponding level of expenditures for at least the next 12 months, although no assurance can be given that the Company will not need additional funds prior to such time. If there are unexpected increases in its operating expenses, the Company may need to seek additional financing during the next 12 months. The Company may also need additional funds to realize the decisions made as part of its strategic review process. The Company cannot predict the outcome of these activities. On August 7, 2023, the Company entered into a Stock Purchase Agreement, as subsequently amended on August 9, 2023 and August 21, 2023, (the “Sorrento SPA”), with Sorrento Therapeutics, Inc. (“Sorrento”), to acquire certain equity securities of Scilex Holding Company (“Scilex”), owned by Sorrento (the “Purchased Securities”), for a purchase price of $105,000. Sorrento and its affiliated debtor, Scintilla Pharmaceuticals, Inc. (“Scintilla” and together with Sorrento, the “Debtors”) are in Chapter 11 bankruptcy proceedings. On August 9, 2023, the Company entered into a Senior Secured, Super-Priority Debtor-in-Possession Loan and Security Agreement (the “Senior DIP Loan Agreement”) with the Debtors in the principal amount of $100,000, which included a non-refundable closing fee of $450 paid in full out of the proceeds. This amount was subsequently drawn in full by the Debtors and was intended to be used by the Company as a credit for the consideration for the Purchased Securities, with an additional $5,000 in cash to be paid by the Company at closing. Thereafter, the Company and Sorrento continued discussions and negotiations relating to the sale contemplated under the Sorrento SPA. On September 21, 2023, the Company entered into and consummated the transactions contemplated by a Securities Purchase Agreement (the “Scilex SPA”) with Scilex and Acquiom Agency Services LLC. Pursuant to the Scilex SPA, in exchange for Scilex assuming outstanding obligations of Sorrento under the Senior DIP Loan Agreement (the “DIP Assumption”) and for the ability to credit the amounts assumed under the DIP Assumption in exchange for certain equity securities of Scilex owned by Sorrento, Scilex (i) issued to the Company (A) a Senior Secured Promissory Note due 18 months from the date of issuance in the principal amount of $101,875 (the “Note”), which includes accrued and unpaid interest of $875 under the Senior DIP Loan Agreement and $1,000 of fees added to the principal amount of the Note, (B) the Closing Penny Warrant (as defined herein), and (C) the Subsequent Penny Warrants (as defined herein), and (ii) caused the Transferred Warrants (as defined herein) to be transferred to the Company. For further details, see note 7. On August 8, 2023, the Company borrowed an aggregate of $99,550 pursuant to loan agreements from Israel Discount Bank Ltd. For further details, see note 6. |
Significant Accounting Policies
Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES: a. Condensed consolidated financial statements preparation The condensed consolidated financial statements included herein have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) and, on the same basis as the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 (the “2022 Form 10-K”). These condensed consolidated financial statements reflect all adjustments that are of a normal recurring nature and that are considered necessary for a fair statement of the results of the periods presented. Certain information and disclosures normally included in annual consolidated financial statements have been omitted in this interim period report pursuant to the rules and regulations of the Securities and Exchange Commission. Because the condensed consolidated interim 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 consolidated financial statements and notes included in the 2022 Form 10-K. The results for interim periods are not necessarily indicative of a full fiscal year’s results. b. Loss per common share Basic and diluted net loss per share of common stock are computed by dividing the net loss attributable to stockholders for the period by the weighted average number of shares of common stock outstanding for each period, including vested restricted stock units (“RSUs”). Outstanding stock options, warrants and unvested RSUs have been excluded from the calculation of the diluted loss per share because all such securities are anti-dilutive for all periods presented. The weighted average number of common stock options, warrants and RSUs excluded from the calculation of diluted net loss was 3,745,590 and 3,557,200 for the nine month periods ended September 30, 2023 and September 30, 2022, respectively, and 3,845,271 and 3,715,540 for the three month periods ended September 30, 2023 and September 30, 2022, respectively. c. Revenue recognition HTIT On November 30, 2015, the Company entered into a Technology License Agreement, with Hefei Tianhui Incubator of Technologies Co. Ltd. (“HTIT”) and on December 21, 2015, the parties entered into an Amended and Restated Technology License Agreement that was further amended by the parties on June 3, 2016 and July 24, 2016 (the “HTIT License Agreement”). As of September 30, 2023, an aggregate amount of $22,382 was allocated to the HTIT License Agreement, all of which were received through the balance sheet date. Through September 30, 2023, the Company recognized revenue associated with this agreement in the aggregate amount of $20,382, of which $1,340 was recognized in the nine month period ended September 30, 2023, and deferred the remaining amount of $2,000, which is presented as long-term deferred revenues on the condensed consolidated balance sheet. Medicox On November 13, 2022, the Company entered into a distribution license agreement (“Medicox License Agreement”) with Medicox Co., Ltd. (“Medicox”). The Medicox License Agreement grants Medicox an exclusive license to apply for regulatory approval and distribute ORMD-0801 in the Republic of Korea. For further details, see note 3a. Under ASC 606, the Company identified Medicox as a customer and the Medicox License Agreement as a contract with a customer. The Company identified a performance obligation in the Medicox License Agreement to stand-ready and provide Medicox with support in its commercialization efforts in the Republic of Korea. This performance obligation includes a non-distinct distribution license for ORMD-0801, which the Company views a predominant item in the combined performance obligation. The Company concluded that the license is not distinct, as no party other than the Company is capable of providing related services to Medicox, and both the license and related services are necessary for the customer to obtain a regulatory approval in the Republic of Korea. In addition, the agreement covers the terms of future manufacturing services, that are contingent on the completion and success of the commercialization efforts. The Medicox License Agreement contains a fixed consideration of $2,000, which was received by the Company in fiscal year 2022 and is presented under long-term deferred revenues as of September 30, 2023. It also contains variable consideration of contractual milestone payments and sales-based royalties. The Company’s obligation to stand-ready and support Medicox will be recognized on a straight-line basis over the period the Company expects to provide support to Medicox. As of September 30, 2023, this support has not commenced, and no revenue was recognized from the Medicox License Agreement. If Medicox proceeds with the regulatory approval process in the Republic of Korea, the Company expects most of the revenue to be recognized at a later stage. The Company notes that its Phase 3 trial did not meet its primary and secondary endpoints. If Medicox chooses to terminate the agreement as a result of the outcome of the applicable Phase 3 trials, the Company expects to accelerate revenue recognition and recognize it at such time. d. Recently adopted accounting pronouncements Financial instruments – credit losses In June 2016, the Financial Accounting Standards Board issued Accounting Standards Update 2016-13 “Financial Instruments—Credit Losses—Measurement of Credit Losses on Financial Instruments.” This guidance replaces the incurred loss impairment methodology with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The guidance became effective for the fiscal year beginning after December 15, 2022, including interim periods within that year. The Company adopted the provisions of this update as of January 1, 2023, with no material impact on its consolidated financial statements. e. Fair value The Company measures fair value and discloses fair value measurements for financial assets and liabilities. Fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, the guidance establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described as follows: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2: Observable prices that are based on inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. As of September 30, 2023, the fair value of marketable equity securities as presented in note 4 and of the Transferred Warrants included in the Scilex SPA as presented in note 7 were based on a Level 1 measurement. The fair value of held to maturity bonds as presented in note 4 and of the Closing Penny Warrant as presented in note 7 were based on a Level 2 measurement. The fair value of the investment in non-marketable equity securities as presented in note 5, of the Subsequent Penny Warrants as presented in note 7 and of the Note as presented in note 7 were based on a Level 3 measurement. As of September 30, 2023, the carrying amounts of cash equivalents, short-term deposits, Short-Term Borrowings and accounts payable approximate their fair values due to the short-term maturities of these instruments. The amounts funded in respect of employee rights are stated at cash surrender value which approximates its fair value. |
Commitments
Commitments | 9 Months Ended |
Sep. 30, 2023 | |
Commitments [Abstract] | |
COMMITMENTS | NOTE 3 - COMMITMENTS a. Medicox License Agreement On November 13, 2022, the Company entered the Medicox License Agreement with Medicox. The Medicox License Agreement grants Medicox an exclusive license to apply for regulatory approval and distribute ORMD-0801 in the Republic of Korea. The Medicox License Agreement is for ten years, but the parties have the right to terminate it upon 180 days’ notice. Medicox will comply with agreed distribution targets and will purchase ORMD-0801 at an agreed upon transfer price per capsule. In addition, Medicox will pay the Company up to $15,000 in developmental milestones, $2,000 of which have already been received by the Company, and up to 15% royalties on gross sales. Medicox will also be responsible for obtaining a regulatory approval in the Republic of Korea. The Company is currently evaluating with Medicox a path forward to continue its collaboration, following the results of the ORA-D-013-1 Phase 3 trial. For the Company’s revenue recognition policy, see note 2c. b. Grants from the Israel Innovation Authority (“IIA”) Under the terms of the Company’s funding from the IIA, royalties of 3% are payable on sales of products developed from a project so funded, up to a maximum amount equaling 100%-150% of the grants received (dollar linked) with the addition of interest at an annual rate based on LIBOR. At the time the grants were received, successful development of the related projects was not assured. The total amount received through September 30, 2023 was $2,208 ($2,553 including interest). As of September 30, 2023, the liability to the IIA was $59. |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2023 | |
Marketable Securities [Abstract] | |
MARKETABLE SECURITIES | NOTE 4 - MARKETABLE SECURITIES: The Company’s marketable securities include investments in equity securities of DNA GROUP (T.R.) Ltd. (formerly D.N.A Biomedical Solutions Ltd.) (“DNA”), Entera Bio Ltd. (“Entera”), and the Transferred Warrants (as defined herein; for further details, see note 7). As of December 31, 2022, marketable securities also included held to maturity securities. a. Composition September 30, December 31, Short-term: DNA (see b below) $ - $ 352 Entera (see c below) - 85 Held to maturity securities (see d below) - 3,306 $ - $ 3,743 Long-term: DNA (see b below) $ 450 $ - Entera (see c below) 85 - Transferred Warrants (see note 7) 2,000 - $ 2,535 $ - b. DNA The DNA ordinary shares are traded on the Tel Aviv Stock Exchange. The fair value of those securities is measured at the quoted prices of the securities on the measurement date. During the nine month period ended September 30, 2023, the Company did not sell any of DNA’s ordinary shares. As of September 30, 2023, the Company owns approximately 1.4% of DNA’s outstanding ordinary shares. The cost of the securities as of both September 30, 2023 and December 31, 2022 was $595. c. Entera Entera ordinary shares have been traded on the Nasdaq Capital Market since June 28, 2018. The Company measures the investment at fair value from such date, since it has a readily determinable fair value (prior to such date the investment was accounted for as a cost method investment (amounting to $1)). d. Held to maturity securities The Company did not have any held to maturity securities as of September 30, 2023. The amortized cost and estimated fair value of held to maturity securities as of December 31, 2022, were as follows: December 31, 2022 Amortized Gross Estimated Average yield to Short-term: Commercial bonds $ 3,258 $ (82 ) $ 3,176 1.07 % Accrued interest 48 - 48 $ 3,306 $ (82 ) $ 3,224 |
Non-Marketable Equity Securitie
Non-Marketable Equity Securities | 9 Months Ended |
Sep. 30, 2023 | |
Non-Marketable Equity Securities [Abstract] | |
NON-MARKETABLE EQUITY SECURITIES | NOTE 5 – NON-MARKETABLE EQUITY SECURITIES: On August 26, 2022, the Company entered into a stock purchase agreement with Diasome Pharmaceuticals, Inc. (“Diasome”), a privately-held company, pursuant to which the Company purchased shares of Series B preferred stock of Diasome for an aggregate purchase price of approximately $2,700. Following the purchase, the Company holds less than 5% of the issued and outstanding stock of Diasome. The stock purchase agreement provides the Company with the option to purchase additional preferred shares of stock on a pro rata basis at similar terms to the terms and conditions of the current round contingent upon Diasome achieving certain milestones. The Company accounts for the investment under the measurement alternative in ASC 321 “Investments – Equity Securities,” whereby the equity investment is recorded at cost, less impairment. The carrying amount is subsequently remeasured to its fair value in accordance with the provisions of ASC 820 “Fair Value Measurement” when observable price changes occur as of the date the transaction occurred, or it is impaired. Any adjustments to the carrying amount are recorded in the statements of comprehensive loss. The Company’s non-marketable equity securities are an investment in a company without a readily determinable fair value. As of September 30, 2023, the Company recorded an $824 increase in value due to the closing in June 2023 of a Series C investment round in Diasome. The change was recorded using the transaction price of similar securities issued by Diasome, adjusted for contractual rights and obligations of the securities held by the Company. |
Financing
Financing | 9 Months Ended |
Sep. 30, 2023 | |
Financing [Abstract] | |
FINANCING | NOTE 6 - FINANCING: On August 8, 2023, the Company borrowed an aggregate of $99,550 pursuant to loan agreements from Israel Discount Bank Ltd. (the “Short-Term Borrowings”). The Short-Term Borrowings mature on dates ranging from August 11, 2023 to May 24, 2024, bear interest ranging from 6.66% to 7.38%, and are secured by certificates of deposits issued by Israel Discount Bank Ltd. having an aggregate face amount of $99,550. The net proceeds of the Short-Term Borrowings were used to fund the Note (for further details, see note 7). The Short-Term Borrowings are paid in one payment of principal and interest at each respective maturity. As of September 30, 2023, $25,000 was repaid under the Short-Term Borrowings. Annual 2023 $ 25,000 2024 49,550 Total $ 74,550 |
Investments, at Fair Value
Investments, at Fair Value | 9 Months Ended |
Sep. 30, 2023 | |
Investments, at Fair Value [Abstract] | |
INVESTMENTS, AT FAIR VALUE | NOTE 7 - INVESTMENTS, AT FAIR VALUE: Scilex Transaction On September 21, 2023 (the “Closing Date”), the Company entered into and consummated the transactions (collectively, the “Transaction”) contemplated by the Scilex SPA with Scilex and Acquiom Agency Services LLC. Pursuant to the Scilex SPA, in exchange for the DIP Assumption and for the ability to credit the amounts assumed under the DIP Assumption in exchange for certain equity securities of Scilex owned by Sorrento, Scilex (i) issued to the Company (A) the Note, (B) a warrant to purchase up to an aggregate of 4,500,000 shares of common stock of Scilex, par value $0.0001 per share (“Scilex Common Stock”), with an exercise price of $0.01 per share and containing certain restrictions on exercisability (the “Closing Penny Warrant”), and (C) warrants to purchase up to an aggregate of 8,500,000 shares of Scilex Common Stock (the “Subsequent Penny Warrants” and together with the Closing Penny Warrant, the “Penny Warrants”), each with an exercise price of $0.01 per share and each with certain restrictions on exercisability, and (ii) caused certain outstanding warrants to purchase up to an aggregate of 4,000,000 shares of Scilex Common Stock with an exercise price of $11.50 per share to be transferred to the Company (the “Transferred Warrants” and together with the Penny Warrants, the “Warrants”). In addition, on the Closing Date, Scilex reimbursed $1,910 of the Company’s Transaction expenses pursuant to the Scilex SPA. Pursuant to the terms of the Scilex SPA, Scilex agreed to certain restrictions on additional issuances of equity securities. In connection with the Transaction, the Company and Sorrento mutually agreed to terminate the Sorrento SPA and to release all claims the Company and Sorrento may have against one another, and Scilex completed the acquisition of the Purchased Securities. Note The principal of the Note issued on September 21, 2023 is $101,875, which includes accrued and unpaid interest of $875 under the Senior DIP Loan Agreement and $1,000 of fees added to the principal amount of the Note. The Note matures on March 21, 2025 or upon an uncured event of default, subject to certain mandatory prepayments, and bears interest at a rate per annum equal to Term SOFR (as defined in the Note) plus 8.5% (subject to a Term SOFR floor of 4.0%), to be paid in-kind, by being capitalized and added to the principal amount of the Note on a monthly basis. The Scilex SPA provides for principal payments of (i) $5,000 on December 21, 2023, (ii) $15,000 on March 21, 2024, and (iii) $20,000 on each of June 21, 2024, September 21, 2024, and December 21, 2024, and for the entire remaining principal balance of the Note to be paid on March 21, 2025. If the Note is not repaid in full on or prior to March 21, 2024, an exit fee equal to approximately $3,056 shall be payable upon repayment of the Note in full. The Note constitutes senior secured indebtedness of Scilex and is guaranteed by all existing or future formed, direct and indirect, domestic subsidiaries of Scilex and is secured by a first priority security interest in and liens on all of the assets of Scilex, subject to customary and mutually agreed permitted liens and except for certain specified exemptions. Mandatory prepayments under the Note are required following the earlier of (a) April 1, 2024 and (b) the date upon which certain of Scilex’s outstanding indebtedness are repaid in full. Mandatory prepayments may be triggered by certain future equity and debt issuances by Scilex. Voluntary prepayments may be made at Scilex’s discretion; provided that, if made prior to the one-year anniversary of the Closing Date, Scilex will also be required to pay a 50% interest make-whole on the portion of the Note so prepaid. The Note includes customary events of default, upon which the Note will bear interest at a default rate of Term SOFR plus 15.0%, which shall be payable in-kind, by being capitalized and added to the principal amount of the Note on a monthly basis. If the Note is accelerated upon an event of default, Scilex is required to repay the principal amount of the Note at a mandatory default rate of 125% of such principal amount (together with 100% of accrued and unpaid interest thereon and all other amounts due in respect of the Note). Until the obligations under the Note are repaid in full, the Company has the right to designate one non-voting observer to attend meetings of the board of directors and committees of Scilex and its subsidiaries. Closing Penny Warrant The Closing Penny Warrant will be exercisable upon the earliest of (i) March 14, 2025, (ii) the date on which the Senior Secured Note has been repaid in full and (iii) the Management Sale Trigger Date (as defined therein), if any, and will expire on the date that is the fifth anniversary of the issuance date (i.e., September 21, 2028). For purposes of the Penny Warrants, the Management Sale Trigger Date is generally the first date that either Dr. Henry Ji, Scilex’s Executive Chairperson, or Mr. Jaisim Shah, Scilex’s Chief Executive Officer and President and a member of Scilex’s Board of Directors, engages in certain sales or other similar transfers of shares of Common Stock or other of the Issuer’s or any of its subsidiaries’ securities, subject to certain exceptions in connection with financings or similar transactions. The exercise price of the Closing Penny Warrant is $0.01 per share, subject to adjustment. Subsequent Penny Warrants Scilex issued four Subsequent Penny Warrants to the Company, each for 2,125,000 shares of Scilex Common Stock, one of which shall vest and become exercisable on the date that is the later of (i) each of March 19, 2024, June 17, 2024, September 15, 2024 or December 14, 2024 (the “Subsequent Penny Warrant Vesting Date”) and (ii) the earliest of (A) March 14, 2025, (B) the date on which the Senior Secured Note has been repaid in full and (C) the Management Sale Trigger Date (as defined therein), if any. Each Subsequent Penny Warrant will expire on the date that is the fifth anniversary of the issuance date; provided that, if the Senior Secured Note is repaid in full prior to the Subsequent Penny Warrant Vesting Date applicable to such Subsequent Penny Warrant, such Subsequent Penny Warrant will expire on the date the Senior Secured Note is repaid in full. The Company may exercise the Penny Warrants by means of a “cashless exercise.” The Penny Warrants may not be exercised if the Company, together with its affiliates, would beneficially own in excess of 9.9% of the number of shares of Scilex Common Stock outstanding immediately after giving effect to such exercise; provided, that the Company may increase or decrease such limitation upon 61 days’ prior notice to Scilex. Transferred Warrants The Transferred Warrants are listed on the Nasdaq Capital Market, have an exercise price of $11.50 per share, are fully exercisable and expire on November 10, 2027. The Company accounted for the Transferred Warrants as derivatives measured at fair value. The Company elected the fair value option for the Note and the Penny Warrants in order to reduce operational complexity of bifurcating embedded derivatives. Changes in value are recorded under financial income, net and include interest income on the Note. The valuation was performed based on several scenarios which some of them took into account a partial or full early repayment of the Note. Each scenario took into consideration the present value of the Note’s cash flows (including the exit fee and the prepayment premium) and the Warrants’ value. The total value of the Transaction (and of each of its components) was valued on a weighted average of the different scenarios. The discount rate of the Note was based on the B- rating Zero curve in addition to a risk premium which takes into account the credit risk of Scilex and ranged between 54.80% to 55.25%. The fair value of the Transferred Warrants was based on their closing price on the Nasdaq Capital Market. The fair value of the Penny Warrants was calculated based on the closing price of the Scilex stock on the Nasdaq Capital Market, taking into account several scenarios which assume a partial or full early repayment of the Note, when applicable. On the Closing Date, the fair value of the Transaction was $101,875. As of September 30, 2023, the fair value of the Transaction was $98,819, split between the Note ($80,404, of which $49,413 is presented under short-term investments at fair value and $30,991 is presented under long-term investments at fair value), the Closing Penny Warrant ($6,300), the Subsequent Penny Warrants ($10,115), both presented under long-term investments at fair value and the Transferred Warrants ($2,000) presented under long-term marketable securities. This resulted in a loss of $3,056, attributed mainly to the change in fair value of the Warrants. The difference between the Note’s fair value and aggregate unpaid principal balance (which includes interest payable on maturity) is $21,826. |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2023 | |
Stockholders' Equity Note [Abstract] | |
STOCKHOLDERS' EQUITY | NOTE 8 - STOCKHOLDERS’ EQUITY: 1. On September 1, 2021, the Company entered into a controlled equity offering agreement (the “Cantor Equity Distribution Agreement”) with Cantor Fitzgerald & Co., as agent, pursuant to which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $100,000, through a sales agent, subject to certain terms and conditions. Any shares sold will be sold pursuant to the Company’s effective shelf registration statement on Form S-3 including a prospectus dated July 26, 2021 and prospectus supplement dated September 1, 2021. The Company paid the sales agent a cash commission of 3.0% of the gross proceeds of the sale of any shares sold through the sales agent under the Cantor Equity Distribution Agreement. As of September 30, 2023 and November 9, 2023, 1,971,447 shares were issued under the Cantor Equity Distribution Agreement for aggregate net proceeds of $26,253. 2. On April 17, 2023, the Company granted an aggregate of 868,500 RSUs representing a right to receive shares of the Company’s common stock to executive officers and board members of the Company. The RSUs will vest in twelve equal quarterly installments starting May 1, 2023. The total fair value of these RSUs on the date of grant was $1,980, using the quoted closing market share price of $2.28 on the Nasdaq Capital Market on the date of grant. 3. On April 17, 2023, the Company granted an aggregate of 245,500 performance based RSUs (“PSUs”) representing a right to receive shares of the Company’s common stock to executive officers of the Company. The PSUs vested on May 26, 2023, upon the Company’s common stock achieving and maintaining a specified price per share. The total fair value of these PSUs on the date of grant was $550, using the Monte-Carlo model. 4. On May 1, 2023, the Company granted an aggregate of 20,000 RSUs representing a right to receive shares of the Company’s common stock to a board member. The RSUs will vest in twelve quarterly installments starting May 1, 2023. The total fair value of these RSUs on the date of grant was $49, using the quoted closing market share price of $2.45 on the Nasdaq Capital Market on the date of grant. 5. During the third quarter of 2023, 86,500 stock options and 110,917 unvested RSUs were forfeited, due to termination of the employment of an executive officer, resulting in a reversal of $663 in sales and marketing expenses. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
LEASES | NOTE 9 - LEASES: The Company has various operating leases for office space and vehicles that expire through 2027. Below is a summary of the Company’s operating right-of-use assets and operating lease liabilities as of September 30, 2023 and December 31, 2022: September 30, 2023 December 31, Operating right-of-use assets $ 768 $ 987 Operating lease liabilities, current 251 247 Operating lease liabilities long-term 389 647 Total operating lease liabilities $ 640 $ 894 Lease payments for the Company’s right-of-use assets over the remaining lease periods as of September 30, 2023 and December 31, 2022 are as follows: September 30, 2023 December 31, 2023 67 291 2024 267 291 2025 210 228 2026 114 124 2027 9 10 Total undiscounted lease payments 667 944 Less: Interest* (27 ) (50 ) Present value of lease liabilities $ 640 $ 894 * Future lease payments were discounted by 3%-5.75% interest rate. |
Related Party Transactions
Related Party Transactions | 9 Months Ended |
Sep. 30, 2023 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | NOTE 10 - RELATED PARTY TRANSACTIONS: On July 1, 2008, the Company’s wholly-owned subsidiary, Oramed Ltd. (the “Subsidiary”), entered into two consulting agreements with KNRY Ltd. (“KNRY”), an Israeli company owned by the Chief Scientific Officer, whereby the President and Chief Executive Officer and the Chief Scientific Officer, through KNRY, provide services to the Company (the “Consulting Agreements”). The Consulting Agreements are both terminable by either party upon 140 days prior written notice. The Consulting Agreements, as amended, provide that KNRY will be reimbursed for reasonable expenses incurred in connection with the performance of the Consulting Agreements and that the monthly consulting fee paid to the President and Chief Executive Officer and the Chief Scientific Officer is NIS 146,705 ($38) and NIS 106,400 ($28), respectively. In addition to the Consulting Agreements, based on a relocation cost analysis, the Company paid for certain direct costs, related taxes and expenses incurred in connection with the relocation of the President and Chief Executive Officer to the U.S. During the nine months ended September 30, 2023, there were no such relocation expenses, compared to $201 for the nine months ended September 30, 2022. Following the relocation of the President and Chief Executive Officer to the State of Israel, the Company entered into two agreements with the President and Chief Executive Officer, replacing his above-mentioned consulting agreement through KNRY, substantially on the same terms, in order to allocate his time and services between the Company and the Subsidiary. Effective November 1, 2022, the Company entered into a consulting agreement with Shnida Ltd., whereby the President and Chief Executive Officer, through Shnida Ltd., provides services as President and Chief Executive Officer of the Company. The agreement is terminable by either party upon 140 days prior written notice. The agreement provides that Shnida Ltd. will be reimbursed for reasonable expenses incurred in connection with performance of the agreement and that the President and Chief Executive Officer will receive a monthly consulting fee of NIS 88,023 ($23), plus value added tax. Pursuant to the agreement, Shnida Ltd. and the President and Chief Executive Officer each agree that during the term of the agreement and for a 12-month period thereafter, none of them will compete with the Company nor solicit employees of the Company. In addition, the Company, through the Subsidiary, has entered into an employment agreement with the President and Chief Executive Officer, effective as of November 1, 2022, pursuant to which the President and Chief Executive Officer receives gross monthly salary of NIS 46,901 ($12) in consideration for his services as President and Chief Executive Officer of the Subsidiary. In addition, the President and Chief Executive Officer is provided with a cellular phone and a company car pursuant to the terms of his agreement. |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Condensed consolidated financial statements preparation | a. Condensed consolidated financial statements preparation The condensed consolidated financial statements included herein have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) and, on the same basis as the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 (the “2022 Form 10-K”). These condensed consolidated financial statements reflect all adjustments that are of a normal recurring nature and that are considered necessary for a fair statement of the results of the periods presented. Certain information and disclosures normally included in annual consolidated financial statements have been omitted in this interim period report pursuant to the rules and regulations of the Securities and Exchange Commission. Because the condensed consolidated interim 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 consolidated financial statements and notes included in the 2022 Form 10-K. The results for interim periods are not necessarily indicative of a full fiscal year’s results. |
Loss per common share | b. Loss per common share Basic and diluted net loss per share of common stock are computed by dividing the net loss attributable to stockholders for the period by the weighted average number of shares of common stock outstanding for each period, including vested restricted stock units (“RSUs”). Outstanding stock options, warrants and unvested RSUs have been excluded from the calculation of the diluted loss per share because all such securities are anti-dilutive for all periods presented. The weighted average number of common stock options, warrants and RSUs excluded from the calculation of diluted net loss was 3,745,590 and 3,557,200 for the nine month periods ended September 30, 2023 and September 30, 2022, respectively, and 3,845,271 and 3,715,540 for the three month periods ended September 30, 2023 and September 30, 2022, respectively. |
Revenue recognition | c. Revenue recognition HTIT On November 30, 2015, the Company entered into a Technology License Agreement, with Hefei Tianhui Incubator of Technologies Co. Ltd. (“HTIT”) and on December 21, 2015, the parties entered into an Amended and Restated Technology License Agreement that was further amended by the parties on June 3, 2016 and July 24, 2016 (the “HTIT License Agreement”). As of September 30, 2023, an aggregate amount of $22,382 was allocated to the HTIT License Agreement, all of which were received through the balance sheet date. Through September 30, 2023, the Company recognized revenue associated with this agreement in the aggregate amount of $20,382, of which $1,340 was recognized in the nine month period ended September 30, 2023, and deferred the remaining amount of $2,000, which is presented as long-term deferred revenues on the condensed consolidated balance sheet. Medicox On November 13, 2022, the Company entered into a distribution license agreement (“Medicox License Agreement”) with Medicox Co., Ltd. (“Medicox”). The Medicox License Agreement grants Medicox an exclusive license to apply for regulatory approval and distribute ORMD-0801 in the Republic of Korea. For further details, see note 3a. Under ASC 606, the Company identified Medicox as a customer and the Medicox License Agreement as a contract with a customer. The Company identified a performance obligation in the Medicox License Agreement to stand-ready and provide Medicox with support in its commercialization efforts in the Republic of Korea. This performance obligation includes a non-distinct distribution license for ORMD-0801, which the Company views a predominant item in the combined performance obligation. The Company concluded that the license is not distinct, as no party other than the Company is capable of providing related services to Medicox, and both the license and related services are necessary for the customer to obtain a regulatory approval in the Republic of Korea. In addition, the agreement covers the terms of future manufacturing services, that are contingent on the completion and success of the commercialization efforts. The Medicox License Agreement contains a fixed consideration of $2,000, which was received by the Company in fiscal year 2022 and is presented under long-term deferred revenues as of September 30, 2023. It also contains variable consideration of contractual milestone payments and sales-based royalties. The Company’s obligation to stand-ready and support Medicox will be recognized on a straight-line basis over the period the Company expects to provide support to Medicox. As of September 30, 2023, this support has not commenced, and no revenue was recognized from the Medicox License Agreement. If Medicox proceeds with the regulatory approval process in the Republic of Korea, the Company expects most of the revenue to be recognized at a later stage. The Company notes that its Phase 3 trial did not meet its primary and secondary endpoints. If Medicox chooses to terminate the agreement as a result of the outcome of the applicable Phase 3 trials, the Company expects to accelerate revenue recognition and recognize it at such time. |
Recently adopted accounting pronouncements | d. Recently adopted accounting pronouncements Financial instruments – credit losses In June 2016, the Financial Accounting Standards Board issued Accounting Standards Update 2016-13 “Financial Instruments—Credit Losses—Measurement of Credit Losses on Financial Instruments.” This guidance replaces the incurred loss impairment methodology with a methodology that reflects expected credit losses and requires consideration of a broader range of reasonable and supportable information to inform credit loss estimates. The guidance became effective for the fiscal year beginning after December 15, 2022, including interim periods within that year. The Company adopted the provisions of this update as of January 1, 2023, with no material impact on its consolidated financial statements. |
Fair value | e. Fair value The Company measures fair value and discloses fair value measurements for financial assets and liabilities. Fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, the guidance establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described as follows: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level 2: Observable prices that are based on inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. As of September 30, 2023, the fair value of marketable equity securities as presented in note 4 and of the Transferred Warrants included in the Scilex SPA as presented in note 7 were based on a Level 1 measurement. The fair value of held to maturity bonds as presented in note 4 and of the Closing Penny Warrant as presented in note 7 were based on a Level 2 measurement. The fair value of the investment in non-marketable equity securities as presented in note 5, of the Subsequent Penny Warrants as presented in note 7 and of the Note as presented in note 7 were based on a Level 3 measurement. As of September 30, 2023, the carrying amounts of cash equivalents, short-term deposits, Short-Term Borrowings and accounts payable approximate their fair values due to the short-term maturities of these instruments. The amounts funded in respect of employee rights are stated at cash surrender value which approximates its fair value. |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Marketable Securities [Abstract] | |
Schedule of Marketable Securities Include Investments in Equity Securities | As of December 31, 2022, marketable securities also included held to maturity securities. September 30, December 31, Short-term: DNA (see b below) $ - $ 352 Entera (see c below) - 85 Held to maturity securities (see d below) - 3,306 $ - $ 3,743 Long-term: DNA (see b below) $ 450 $ - Entera (see c below) 85 - Transferred Warrants (see note 7) 2,000 - $ 2,535 $ - |
Schedule of Amortized Cost and Estimated Fair Value of Held-to-Maturity Securities | The amortized cost and estimated fair value of held to maturity securities as of December 31, 2022, were as follows: December 31, 2022 Amortized Gross Estimated Average yield to Short-term: Commercial bonds $ 3,258 $ (82 ) $ 3,176 1.07 % Accrued interest 48 - 48 $ 3,306 $ (82 ) $ 3,224 |
Financing (Tables)
Financing (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Financing [Abstract] | |
Schedule of Annual Principal Payments on Debt | The aggregate remaining annual principal payments on debt until maturity are as follows: Annual 2023 $ 25,000 2024 49,550 Total $ 74,550 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Leases [Abstract] | |
Schedule of Operating Right-of-use Assets and Operating Lease Liabilities | The Company has various operating leases for office space and vehicles that expire through 2027. Below is a summary of the Company’s operating right-of-use assets and operating lease liabilities as of September 30, 2023 and December 31, 2022: September 30, 2023 December 31, Operating right-of-use assets $ 768 $ 987 Operating lease liabilities, current 251 247 Operating lease liabilities long-term 389 647 Total operating lease liabilities $ 640 $ 894 |
Schedule of Right-of-use Assets Over the Remaining Lease Periods | Lease payments for the Company’s right-of-use assets over the remaining lease periods as of September 30, 2023 and December 31, 2022 are as follows: September 30, 2023 December 31, 2023 67 291 2024 267 291 2025 210 228 2026 114 124 2027 9 10 Total undiscounted lease payments 667 944 Less: Interest* (27 ) (50 ) Present value of lease liabilities $ 640 $ 894 * Future lease payments were discounted by 3%-5.75% interest rate. |
General (Details)
General (Details) - USD ($) $ in Thousands | 9 Months Ended | |||
Sep. 21, 2023 | Aug. 09, 2023 | Aug. 08, 2023 | Sep. 30, 2023 | |
General [Line Items] | ||||
Capital stock shares issued (in Shares) | 1,890,000 | |||
Shares issued and outstanding percentage | 63% | |||
Purchase price | $ 105,000 | |||
Non-refundable closing fee paid | $ 450 | |||
Additional cash paid | 5,000 | |||
Principal amount | $ 101,875 | $ 99,550 | ||
Accrued and unpaid interest | 875 | |||
Aggregate face amount | $ 99,550 | |||
Senior DIP Loan Agreement [Member] | ||||
General [Line Items] | ||||
Debtors principal amount | $ 100,000 | |||
Loan processing fee | $ 1,000 |
Significant Accounting Polici_2
Significant Accounting Policies (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Jun. 30, 2023 | Sep. 30, 2023 | Sep. 30, 2022 | |
Significant Accounting Policies (Details) [Line Items] | |||||
Diluted net loss (in Shares) | 3,845,271 | 3,715,540 | 3,745,590 | 3,557,200 | |
Recognized revenue aggregate amount | $ 20,382 | ||||
Recognized amount | 1,340 | ||||
Deferred remaining amount | $ 2,000 | ||||
Fixed consideration | $ 2,000 | ||||
HTIT License Agreement [Member] | |||||
Significant Accounting Policies (Details) [Line Items] | |||||
Aggregate amount | $ 22,382 |
Commitments (Details)
Commitments (Details) - USD ($) $ in Thousands | 9 Months Ended | |||
Nov. 13, 2022 | Sep. 30, 2023 | Sep. 21, 2023 | Aug. 08, 2023 | |
Commitments [Line Items] | ||||
Agreement term | ten | |||
Development amount | $ 15,000 | |||
Development received amount | $ 2,000 | |||
Royalties percentage | 15% | |||
Interest amount | $ 101,875 | $ 99,550 | ||
Interest amount | $ 2,553 | |||
Liability | $ 59 | |||
Israel Innovation Authority [Member] | ||||
Commitments [Line Items] | ||||
Royalties percentage | 3% | |||
Interest amount | $ 2,208 | |||
Minimum [Member] | Israel Innovation Authority [Member] | ||||
Commitments [Line Items] | ||||
Royalty percentage | 100% | |||
Maximum [Member] | Israel Innovation Authority [Member] | ||||
Commitments [Line Items] | ||||
Royalty percentage | 150% |
Marketable Securities (Details)
Marketable Securities (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Marketable Securities [Line Items] | ||
Cost of securities | $ 595 | $ 595 |
Cost method investments | $ 1 | |
DNA [Member] | ||
Marketable Securities [Line Items] | ||
Ownership percentage | 1.40% |
Marketable Securities (Detail_2
Marketable Securities (Details) - Schedule of Marketable Securities Include Investments in Equity Securities - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Short-term: | ||
Total Short-term | $ 3,743 | |
Long-term: | ||
Total Long-term | 2,535 | |
DNA [Member] | ||
Short-term: | ||
Total Short-term | 352 | |
Long-term: | ||
Total Long-term | 450 | |
Entera [Member] | ||
Short-term: | ||
Total Short-term | 85 | |
Long-term: | ||
Total Long-term | 85 | |
Held-to-Maturity Securities [Member] | ||
Short-term: | ||
Total Short-term | 3,306 | |
Transferred Warrants [Member] | ||
Long-term: | ||
Total Long-term | $ 2,000 |
Marketable Securities (Detail_3
Marketable Securities (Details) - Schedule of Amortized Cost and Estimated Fair Value of Held-to-Maturity Securities $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Marketable Securities [Line Items] | |
Amortized cost | $ 3,306 |
Gross unrealized gains (losses) | (82) |
Estimated fair value | 3,224 |
Commercial bonds [Member] | |
Marketable Securities [Line Items] | |
Amortized cost | 3,258 |
Gross unrealized gains (losses) | (82) |
Estimated fair value | $ 3,176 |
Average yield to maturity rate | 1.07% |
Accrued interest [Member] | |
Marketable Securities [Line Items] | |
Amortized cost | $ 48 |
Gross unrealized gains (losses) | |
Estimated fair value | $ 48 |
Non-Marketable Equity Securit_2
Non-Marketable Equity Securities (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Aug. 26, 2022 | Sep. 30, 2023 | |
Non-Marketable Equity Securities (Details) [Line Items] | ||
Issued and outstanding stock | 5% | |
Equity securities | $ 824 | |
Series B Preferred Stock [Member] | ||
Non-Marketable Equity Securities (Details) [Line Items] | ||
Aggregate purchase price | $ 2,700 |
Financing (Details)
Financing (Details) - USD ($) $ in Thousands | Sep. 30, 2023 | Sep. 21, 2023 | Aug. 08, 2023 |
Financing [Line Items] | |||
Loan agreements | $ 99,550 | ||
Aggregate face amount | $ 101,875 | $ 99,550 | |
Short-term borrowings | $ 25,000 | ||
Minimum [Member] | |||
Financing [Line Items] | |||
Bear interest percentage | 6.66% | ||
Maximum [Member] | |||
Financing [Line Items] | |||
Bear interest percentage | 7.38% |
Financing (Details) - Schedule
Financing (Details) - Schedule of Annual Principal Payments on Debt $ in Thousands | Sep. 30, 2023 USD ($) |
Schedule of Annual Principal Payments on Debt [Abstract] | |
2023 | $ 25,000 |
2024 | 49,550 |
Annual Principal Payments | $ 74,550 |
Investments, at Fair Value (Det
Investments, at Fair Value (Details) - USD ($) | 9 Months Ended | ||
Sep. 21, 2023 | Sep. 30, 2023 | Jun. 30, 2023 | |
Investments, at Fair Value [Line Items] | |||
Warrant per share (in Dollars per share) | $ 11.5 | ||
Sale of Stock, Percentage of Ownership after Transaction | 9.90% | ||
Fair value transaction | $ 101,875,000 | ||
Short term investment | 49,413 | ||
Long term investment | 30,991 | ||
Aggregate unpaid principal balance amount | $ 21,826,000 | ||
Maximum [Member] | |||
Investments, at Fair Value [Line Items] | |||
Discount rate | 55.25% | ||
Fair value transaction | $ 98,819,000 | ||
Minimum [Member] | |||
Investments, at Fair Value [Line Items] | |||
Discount rate | 54.80% | ||
Fair value transaction | $ 80,404,000 | ||
Closing Penny Warrant [Member] | |||
Investments, at Fair Value [Line Items] | |||
Fair value transaction | (6,300,000) | ||
Subsequent Penny Warrants [Member] | |||
Investments, at Fair Value [Line Items] | |||
Fair value transaction | (10,115,000) | ||
Transferred Warrants [Member] | |||
Investments, at Fair Value [Line Items] | |||
Fair value transaction | (2,000,000) | ||
Warrant [Member] | |||
Investments, at Fair Value [Line Items] | |||
Fair value transaction | $ 3,056,000 | ||
Scilex Holding Company [Member] | Common Stock [Member] | |||
Investments, at Fair Value [Line Items] | |||
Aggregate shares (in Shares) | 2,125,000 | ||
Scilex Transaction [Member] | |||
Investments, at Fair Value [Line Items] | |||
Aggregate shares (in Shares) | 4,000,000 | ||
Warrant per share (in Dollars per share) | $ 11.5 | ||
Principal of note issued | $ 101,875,000 | ||
Fees added to principal amount | $ 1,000,000 | ||
Bear interest rate | 8.50% | 50% | |
Disclosure of principal payments | The Scilex SPA provides for principal payments of (i) $5,000 on December 21, 2023, (ii) $15,000 on March 21, 2024, and (iii) $20,000 on each of June 21, 2024, September 21, 2024, and December 21, 2024, and for the entire remaining principal balance of the Note to be paid on March 21, 2025. If the Note is not repaid in full on or prior to March 21, 2024, an exit fee equal to approximately $3,056 shall be payable upon repayment of the Note in full. | ||
Scilex Transaction [Member] | Maximum [Member] | |||
Investments, at Fair Value [Line Items] | |||
Bear interest rate | 125% | ||
Scilex Transaction [Member] | Minimum [Member] | |||
Investments, at Fair Value [Line Items] | |||
Bear interest rate | 100% | ||
Scilex Transaction [Member] | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate [Member] | |||
Investments, at Fair Value [Line Items] | |||
Bear interest rate | 4% | 15% | |
Scilex Transaction [Member] | DIP Loan Agreement [Member] | |||
Investments, at Fair Value [Line Items] | |||
Accrued and unpaid interest | $ 875,000 | ||
Scilex Transaction [Member] | Penny Warrants [Member] | |||
Investments, at Fair Value [Line Items] | |||
Aggregate shares (in Shares) | 4,500,000 | ||
Warrant per share (in Dollars per share) | $ 0.01 | ||
Warrant per share (in Dollars per share) | $ 0.01 | ||
Scilex Transaction [Member] | Scilex Holding Company [Member] | Penny Warrants [Member] | |||
Investments, at Fair Value [Line Items] | |||
Aggregate shares (in Shares) | 8,500,000 | ||
Common stock of Scilex, par value (in Dollars per share) | $ 0.0001 | ||
Warrant per share (in Dollars per share) | $ 0.01 | ||
Transaction expenses | $ 1,910,000 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||
Nov. 09, 2023 | May 01, 2023 | Apr. 17, 2023 | Sep. 01, 2021 | Sep. 30, 2023 | Sep. 30, 2023 | |
Class of Stock [Line Items] | ||||||
Aggregate offering price | $ 100,000 | |||||
Cash commission percentage | 3% | |||||
Shares issued | 1,971,447 | |||||
Aggregate net proceeds | $ 26,253 | |||||
Stock options issued | 86,500 | 86,500 | ||||
Sales and marketing expenses | $ 663 | |||||
Subsequent Event [Member] | ||||||
Class of Stock [Line Items] | ||||||
Shares issued | 1,971,447 | |||||
Aggregate net proceeds | $ 26,253 | |||||
Restricted Stock Units (RSUs) [Member] | ||||||
Class of Stock [Line Items] | ||||||
Aggregate granted shares | 20,000 | 868,500 | ||||
Fair value | $ 49 | $ 1,980 | ||||
Market share price | $ 2.45 | $ 2.28 | ||||
Forfeited shares | 110,917 | |||||
PSUs [Member] | ||||||
Class of Stock [Line Items] | ||||||
Aggregate granted shares | 245,500 | |||||
Fair value | $ 550 |
Leases (Details)
Leases (Details) | Sep. 30, 2023 |
Minimum [Member] | |
Lease [Line Items] | |
Future lease payments rate | 3% |
Maximum [Member] | |
Lease [Line Items] | |
Future lease payments rate | 5.75% |
Leases (Details) - Schedule of
Leases (Details) - Schedule of Operating Right-of-use Assets and Operating Lease Liabilities - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
Operating right-of-use assets | $ 768 | $ 987 |
Operating lease liabilities, current | 251 | 247 |
Operating lease liabilities long-term | 389 | 647 |
Total operating lease liabilities | $ 640 | $ 894 |
Leases (Details) - Schedule o_2
Leases (Details) - Schedule of Right-of-use Assets Over the Remaining Lease Periods - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 | |
Leases [Abstract] | |||
2023 | $ 67 | $ 291 | |
2024 | 267 | 291 | |
2025 | 210 | 228 | |
2026 | 114 | 124 | |
2027 | 9 | 10 | |
Total undiscounted lease payments | 667 | 944 | |
Less: Interest | [1] | (27) | (50) |
Present value of lease liabilities | $ 640 | $ 894 | |
[1] Future lease payments were discounted by 3%-5.75% interest rate. |
Related Party Transactions (Det
Related Party Transactions (Details) ₪ in Thousands, $ in Thousands | 1 Months Ended | 9 Months Ended | |||
Nov. 01, 2022 USD ($) | Nov. 01, 2022 ILS (₪) | Jul. 01, 2008 USD ($) | Jul. 01, 2008 ILS (₪) | Sep. 30, 2023 USD ($) | |
Related Party Transactions [Line Items] | |||||
Consulting fee paid | $ 23 | ₪ 88,023 | |||
Relocation expenses | $ 201 | ||||
Gross salary | $ 12 | ₪ 46,901 | |||
Chief Executive Officer [Member] | |||||
Related Party Transactions [Line Items] | |||||
Consulting fee paid | $ 38 | ₪ 146,705 | |||
Chief Scientific Officer [Member] | |||||
Related Party Transactions [Line Items] | |||||
Consulting fee paid | $ 28 | ₪ 106,400 |