Document And Entity Information
Document And Entity Information - shares | 3 Months Ended | |
Mar. 31, 2022 | May 12, 2022 | |
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 | 38,564,016 | |
Amendment Flag | false | |
Entity Central Index Key | 0001176309 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Document Period End Date | Mar. 31, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q1 | |
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 | Mar. 31, 2022 | Dec. 31, 2021 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 27,967 | $ 27,456 |
Short-term deposits | 106,368 | 111,077 |
Marketable securities | 7,275 | 7,747 |
Prepaid expenses and other current assets | 1,952 | 1,657 |
Total current assets | 143,562 | 147,937 |
LONG-TERM ASSETS: | ||
Long-term deposits | 25,151 | 25,094 |
Marketable securities | 1,955 | 3,875 |
Amounts funded in respect of employee rights upon retirement | 24 | 26 |
Property and equipment, net | 424 | 388 |
Operating lease right-of-use assets | 1,108 | 500 |
Total long-term assets | 28,662 | 29,883 |
Total assets | 172,224 | 177,820 |
CURRENT LIABILITIES: | ||
Accounts payable, accrued expenses and other liabilities | 3,310 | 4,535 |
Deferred revenues | 2,703 | 2,703 |
Payable to related parties | 74 | |
Operating lease liabilities | 237 | 130 |
Total current liabilities | 6,324 | 7,368 |
LONG-TERM LIABILITIES: | ||
Long-term deferred revenues | 2,674 | 3,340 |
Employee rights upon retirement | 22 | 22 |
Provision for uncertain tax position | 11 | 11 |
Operating lease liabilities | 871 | 370 |
Other liabilities | 99 | 99 |
Total long-term liabilities | 3,677 | 3,842 |
COMMITMENTS (note 2) | ||
EQUITY ATTRIBUTABLE TO COMPANY’S STOCKHOLDERS: | ||
Common stock, $0.012 par value (60,000,000 authorized shares; 38,564,016 and 38,158,792 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively) | 463 | 459 |
Additional paid-in capital | 298,831 | 292,514 |
Accumulated deficit | (136,945) | (126,520) |
Total stockholders’ equity | 162,349 | 166,453 |
Non-controlling interests | (126) | 157 |
Total equity | 162,223 | 166,610 |
Total liabilities and equity | $ 172,224 | $ 177,820 |
Interim Condensed Consolidate_2
Interim Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
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 | 38,564,016 | 38,158,792 |
Common stock, shares outstanding | 38,564,016 | 38,158,792 |
Interim Condensed Consolidate_3
Interim Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Income Statement [Abstract] | ||
REVENUES | $ 666 | $ 666 |
RESEARCH AND DEVELOPMENT EXPENSES | 5,836 | 6,168 |
SALES AND MARKETING EXPENSES | 590 | |
GENERAL AND ADMINISTRATIVE EXPENSES | 5,492 | 1,102 |
OPERATING LOSS | 11,252 | 6,604 |
FINANCIAL INCOME | 544 | 541 |
NET LOSS FOR THE PERIOD | 10,708 | 6,063 |
NET LOSS ATTRIBUTABLE TO NON-CONTROLLING INTERESTS | 283 | 393 |
NET LOSS ATTRIBUTABLE TO STOCKHOLDERS | $ 10,425 | $ 5,670 |
LOSS PER SHARE | ||
BASIC AND DILUTED LOSS PER SHARE OF COMMON STOCK (in Dollars per share) | $ 0.27 | $ 0.2 |
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING BASIC AND DILUTED LOSS PER SHARE OF COMMON STOCK (in Shares) | 38,679,622 | 27,963,072 |
Interim Condensed Consolidate_4
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, 2020 | $ 320 | $ 138,587 | $ (99,938) | $ 38,969 | $ 38,969 | ||
BALANCE (in Shares) at Dec. 31, 2020 | 26,660 | ||||||
ISSUANCE OF COMMON STOCK, NET | $ 27 | 22,280 | 22,307 | 22,307 | |||
ISSUANCE OF COMMON STOCK, NET (in Shares) | 2,265 | ||||||
EXERCISE OF WARRANTS AND OPTIONS | $ 12 | 6,713 | 6,725 | 6,725 | |||
EXERCISE OF WARRANTS AND OPTIONS (in Shares) | 1,022 | ||||||
STOCK-BASED COMPENSATION | 647 | 647 | 647 | ||||
STOCK-BASED COMPENSATION (in Shares) | |||||||
ASSET ACQUISITION | 1,045 | 1,045 | 1,495 | 2,540 | |||
NET LOSS | (5,670) | (5,670) | (393) | (6,063) | |||
BALANCE at Mar. 31, 2021 | $ 359 | 169,272 | (105,608) | 64,023 | 1,102 | 65,125 | |
BALANCE (in Shares) at Mar. 31, 2021 | 29,947 | ||||||
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 | $ 3 | 2,966 | 2,969 | 2,969 | |||
ISSUANCE OF COMMON STOCK, NET (in Shares) | 277 | ||||||
EXERCISE OF WARRANTS AND OPTIONS | [1] | ||||||
EXERCISE OF WARRANTS AND OPTIONS (in Shares) | 4 | ||||||
STOCK-BASED COMPENSATION | $ 1 | 4,028 | 4,029 | 4,029 | |||
STOCK-BASED COMPENSATION (in Shares) | 125 | ||||||
TAX WITHHOLDINGS RELATED TO STOCK-BASED COMPENSATION SETTLEMENTS | (677) | (677) | (677) | ||||
NET LOSS | (10,425) | (10,425) | (283) | (10,708) | |||
BALANCE at Mar. 31, 2022 | $ 463 | $ 298,831 | $ (136,945) | $ 162,349 | $ (126) | $ 162,223 | |
BALANCE (in Shares) at Mar. 31, 2022 | 38,564 | ||||||
[1] | Less than $1 |
Interim Condensed Consolidate_5
Interim Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (10,708) | $ (6,063) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 11 | 28 |
Non-cash expense for acquired in-process research and development | 1,040 | |
Exchange differences and interest on deposits and held to maturity bonds | (235) | 126 |
Changes in fair value of investments | (110) | (459) |
Stock-based compensation | 4,029 | 647 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (295) | (378) |
Accounts payable, accrued expenses and related parties | (1,151) | 2,063 |
Deferred revenues | (666) | (666) |
Other liabilities | (20) | |
Total net cash used in operating activities | (9,125) | (3,682) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of held to maturity securities | (4,104) | |
Proceeds from sale of short-term deposits | 5,000 | 9,500 |
Proceeds from maturity of held to maturity securities | 2,406 | 2,355 |
Proceeds from sale of mutual funds | 3,029 | |
Funds in respect of employee rights upon retirement | ||
Purchase of property and equipment | (47) | (27) |
Total net cash provided by investing activities | 7,359 | 10,753 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of common stock, net of issuance costs | 2,969 | 22,307 |
Proceeds from exercise of options | 6,725 | |
Tax withholdings related to stock-based compensation settlements | (677) | |
Total net cash provided by financing activities | 2,292 | 29,032 |
EFFECT OF EXCHANGE RATE CHANGES ON CASH | (15) | 8 |
INCREASE IN CASH AND CASH EQUIVALENTS | 511 | 36,111 |
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 27,456 | 21,630 |
CASH AND CASH EQUIVALENTS AT END OF PERIOD | 27,967 | 57,741 |
Interest received | 122 | 263 |
Recognition of operating lease right of use assets and liabilities | 647 | |
(C) ASSET ACQUISITION TRANSACTION (see note 8) - | ||
In-process research and development | 1,040 | |
Note receivable from Akers | 1,500 | |
Additional paid in capital | (1,045) | |
Non-controlling interests | $ (1,495) |
Significant Accounting Policies
Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES: a. General: 1) 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 February 17, 2006, the Company entered into an agreement with Hadasit Medical Services and Development Ltd. to acquire the provisional patent related to an orally ingestible insulin capsule to be used for the treatment of individuals with diabetes. On May 14, 2007, the Company incorporated a wholly-owned subsidiary in Israel, Oramed Ltd. (the “Subsidiary”), which is engaged in research and development. On July 30, 2019, the Subsidiary incorporated a wholly-owned subsidiary in Hong Kong, Oramed HK Limited (the “Hong Kong Subsidiary”). As of March 31, 2022, the Hong Kong Subsidiary has no operations. 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, on a fully diluted basis, 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. 2) Change in Fiscal Year On February 28, 2022, the Board of Directors approved a change of the Company’s fiscal year from the period beginning on September 1 and ending on August 31 to the period beginning on January 1 and ending on December 31. As a result, the Company filed a transition report on Form 10-Q with the Securities and Exchange Commission on March 30, 2022 that included financial information for the transition period from September 1, 2021 through December 31, 2021. Subsequent to that report, the Company’s fiscal year now begins on January 1 and ends on December 31. This Quarterly Report on Form 10-Q is the Company’s first quarterly report in its new fiscal year, and reports financial results for the quarter ended March 31, 2022. 3) 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. Based on the Company’s current cash resources and commitments, the Company believes it will be able to maintain its current planned development 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. Successful completion of the Company’s development programs and its transition to normal operations is dependent upon obtaining necessary regulatory approvals from the U.S. Food and Drug Administration prior to selling its products within the United States, obtaining foreign regulatory approvals to sell its products internationally, or entering into licensing agreements with third parties. There can be no assurance that the Company will receive regulatory approval of any of its product candidates, and a substantial amount of time may pass before the Company achieves a level of revenues adequate to support its operations, if at all. The Company also expects to incur substantial expenditures in connection with the regulatory approval process for each of its product candidates during their respective developmental periods. Obtaining marketing approval will be directly dependent on the Company’s ability to implement the necessary regulatory steps required to obtain marketing approval in the United States and in other countries. The Company cannot predict the outcome of these activities. In addition to the foregoing, based on the Company’s current assessment, the Company does not expect any material impact on its development timeline and its liquidity due to the worldwide spread of COVID-19. However, the Company has experienced approximately six months of delays in clinical trials due to slow-downs of recruitment for trials generally. The Company may experience further delays if the pandemic continues for an extended period of time and it is continuing to assess the effect on its operations by monitoring the spread of COVID-19 and the actions implemented by governments to combat the virus throughout the world. b. Loss per common share Basic and diluted net loss per common share are computed by dividing the net loss for the period by the weighted average number of shares of common stock outstanding for each period. Outstanding stock options, warrants and restricted stock units (“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 3,463,525 and 5,483,784 for the three month periods ended March 31, 2022 and March 31, 2021, respectively. c. Revenue recognition On November 30, 2015, the Company entered into a Technology License Agreement (the “TLA”), 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”). The HTIT License Agreement and a stock purchase agreement, dated November 30, 2015, between the Company and HTIT (the “SPA”) were considered a single arrangement with multiple deliverables. The Company allocated the total consideration of $49,500 between the HTIT License Agreement and the SPA according to their fair value, as follows: $10,617 was allocated to the issuance of common stock (less issuance expenses of $23), based on the quoted price of the Company’s shares on the closing date of the SPA on December 28, 2015, and $38,883 was allocated to the HTIT License Agreement. Under Accounting Standard Codification, (“ASC”) 606, the Company identified a single performance obligation in the agreement and determined that the license and services are not distinct as the license and services are highly dependent on each other. In other words, HTIT cannot benefit from the license without the related services, and vice versa. Since the customer benefits from the services as the entity performs, revenue is recognized over time through the expected product submission date in June 2023, using the input method. The Company used the input method to measure the process for the purpose of recognizing revenue, which approximates the straight line attribution. The Company used significant judgment when it determined the product submission date. Under ASC 606, the consideration that the Company would be entitled to upon the achievement of contractual milestones, which are contingent upon the occurrence of future events, are a form of variable consideration. When assessing the portion, if any, of such milestones-related consideration to be included in the transaction price, the Company first assesses the most likely outcome for each milestone and excludes the consideration related to milestones of which the occurrence is not considered the most likely outcome. The Company then evaluates if any of the variable consideration determined in the first step is constrained by including in the transaction price variable consideration to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company used significant judgment when it determined the first step of variable consideration. The potential future royalty consideration is also considered a form of variable consideration under ASC 606 as it is based on a percentage of potential future sales of the Company’s products. However, the Company applies the sales-based royalty exception and accordingly will recognize the sales-based royalty amounts when the related sale has occurred. To date, the Company has not recognized any royalty-related revenue. As of March 31, 2022, an aggregate amount of $22,382 was allocated to the HTIT License Agreement, all of which were received through the balance sheet date. Through March 31, 2022, the Company has recognized revenue associated with this agreement in the aggregate amount of $17,005, of which $666 was recognized in the quarter ended March 31, 2022, and deferred the remaining amount of $5,377, which is presented as deferred revenues on the condensed consolidated balance sheet. d. 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 August 31, 2021 (the “2021 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 2021 Form 10-K. The results for interim periods are not necessarily indicative of a full fiscal year’s results. e. Recently issued accounting pronouncements, not yet adopted 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 current 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 will be effective for the fiscal year beginning after December 15, 2022, including interim periods within that year. The adoption of this guidance is not expected to have a significant impact on the Company’s consolidated financial statements. |
Commitments
Commitments | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
COMMITMENTS | NOTE 2 - COMMITMENTS: a. In March 2011, the Subsidiary sold shares of its investee company, Entera Bio Ltd. (“Entera”) to D.N.A Biomedical Solutions Ltd. (“D.N.A”), retaining 117,000 ordinary shares (after giving effect to a stock split by Entera in July 2018). In consideration for the shares sold to D.N.A, the Company received, among other payments, ordinary shares of D.N.A (see also note 4). As part of this agreement, the Subsidiary entered into a patent transfer agreement (the “Patent Transfer Agreement”), according to which the Subsidiary assigned to Entera all of its rights to a patent application related to the oral administration of proteins that it has licensed to Entera since August 2010, in return for royalties of 3% of Entera’s net revenues and a license back of that patent application for use in respect of diabetes and influenza. As of March 31, 2022, Entera had not paid any royalties to the Subsidiary. On December 11, 2018, Entera announced that it had entered into a research collaboration and license agreement with Amgen, Inc. (“Amgen”). To the extent that the license granted to Amgen results in net revenues as defined in the Patent Transfer Agreement, the Subsidiary will be entitled to the aforementioned royalties. As part of a consulting agreement with a third party dated February 15, 2011, the Subsidiary is obliged to pay this third party royalties of 8% of the net royalties received in respect of the patent that was sold to Entera in March 2011. b. According to the HTIT License Agreement, the Company granted HTIT an exclusive commercialization license in the territory of the People’s Republic of China, Macau and Hong Kong (the “Territory”), related to the Company’s oral insulin capsule, ORMD-0801 (the “Product”). Pursuant to the HTIT License Agreement, HTIT will conduct, at its own expense, certain pre-commercialization and regulatory activities with respect to the Subsidiary’s technology and ORMD-0801 capsule, and will pay to the Subsidiary (i) royalties of 10% on net sales of the related commercialized products to be sold by HTIT in the Territory (“Royalties”), and (ii) an aggregate of $37,500, of which $3,000 was payable immediately, $8,000 will be paid subject to the Company entering into certain agreements with certain third parties, and $26,500 will be paid upon achievement of certain milestones and conditions. In the event that the Company does not meet certain conditions, the Royalties rate may be reduced to a minimum of 8%. Following the final expiration of the Company’s patents covering the technology in the Territory in 2033, the Royalties rate may be reduced, under certain circumstances, to 5%. The royalty payment obligation shall apply during the period of time beginning upon the first commercial sale of the Product in the Territory, and ending upon the later of (i) the expiration of the last-to-expire licensed patents in the Territory; and (ii) 15 years after the first commercial sale of the Product in the Territory (the “Royalty Term”). The HTIT License Agreement shall remain in effect until the expiration of the Royalty Term. The HTIT License Agreement contains customary termination provisions. Among others, the Company’s involvement through the product submission date will include consultancy for the pre-commercialization activities in the Territory, as well as advisory services to HTIT on an ongoing basis. As of March 31, 2022, the Company has received milestone payments in an aggregate amount of $20,500 as follows: the initial payment of $3,000 was received in January 2016. Following the achievement of certain milestones, the second and third payments of $6,500 and $4,000, respectively, were received in July 2016, the fourth milestone payment of $4,000 was received in October 2016 and the fifth milestone payment of $3,000 was received in January 2019. On August 21, 2020, the Company received a letter from HTIT, disputing certain pending payment obligations of HTIT under the TLA. The payment obligation being disputed is $6,000, out of which only an amount of $2,000 has been received and has been included in deferred revenue in each of the consolidated balance sheets as of March 31, 2022 and December 31, 2021. The Company wholly disputes the claims made by HTIT and has been engaged in discussions and exchanges with HTIT in an attempt to clarify and resolve disagreements between the parties regarding milestone payments and work plan implementation. In addition, on November 30, 2015, the Company entered into the SPA with HTIT, according to which, the Company issued 1,155,367 shares of common stock to HTIT for $12,000. The transaction closed on December 28, 2015. The HTIT License Agreement and the SPA were considered a single arrangement with multiple deliverables. The Company allocated the total consideration of $49,500 between the HTIT License Agreement and the SPA according to their fair value, as follows: $10,617 was allocated to the issuance of common stock (less issuance expenses of $23), based on the quoted price of the Company’s shares on the closing date of the SPA on December 28, 2015, and $38,883 was allocated to the HTIT License Agreement. The Company determined that revenues are recognized over time through the expected product submission date in June 2023. In July 2015, according to the letter of intent signed between the parties or their affiliates, HTIT’s affiliate paid the Subsidiary a non-refundable amount of $500 as a no-shop fee. The no-shop fee was deferred and the related revenue is recognized over the estimated term of the HTIT License Agreement. c. On December 18, 2017, the Subsidiary entered into an agreement with a vendor for the process development and production of one of its oral capsule ingredients in the amount of $2,905 that will be paid over the term of the engagement and based on the achievement of certain development milestones, of which $1,592 was recognized in research and development expenses through March 31, 2022. d. On September 2, 2020 (effective as of January 15, 2020), the Subsidiary entered into a CRO Services Agreement with a third party to retain it as a clinical research organization (“CRO”) for the Subsidiary’s phase 3 clinical trial for its oral insulin. As consideration for its services, the Subsidiary will pay the CRO a total amount of $21,589 during the term of the engagement and based on achievement of certain milestones, of which $11,337 was recognized in research and development expenses through March 31, 2022. e. On September 16, 2020 (effective as of January 15, 2020), the Subsidiary entered into a CRO Services Agreement with a third party to retain it as a CRO for the Subsidiary’s phase 3 clinical trial for its oral insulin. As consideration for its services, the Subsidiary will pay the CRO a total amount of $12,343 during the term of the engagement and based on achievement of certain milestones, of which $4,743 was recognized in research and development expenses through March 31, 2022. f. On December 2, 2021, the Subsidiary entered into an addendum (the “Addendum”) to the current lease agreement for its facilities in Israel. The Addendum refers to the lease of an additional space of 264 square meters for a period of 60 months commencing February 1, 2022. The Subsidiary has the option to extend the period for another 60 months. The annual lease payment, including management fees, is approximately NIS 435 (approximately $137). As security for its obligation under the Addendum, the Company provided a bank guarantee in an amount equal to three monthly lease payments. For accounting purposes, the lease commenced on February 1, 2022 as the Subsidiary did not have access to the space until that date. g. 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 March 31, 2022 was $2,207 ($2,514 including interest). As of March 31, 2022, the liability to the IIA was $169. The royalty expenses which are related to the funded project were recognized in cost of revenues in the relevant periods. h. Legal expenses Following the Company’s 2019 annual meeting of stockholders, a complaint was filed in the Court of Chancery of the State of Delaware against the Company and the members of the Board of Directors. On April 27, 2022, the Court of Chancery of the State of Delaware approved the terms of a settlement between the Company and the plaintiff in the complaint, awarding the plaintiff an amount of $850,000 in attorneys’ fees, which was paid on April 28, 2022 and included in general and administrative expenses. All other details of the settlement were previously agreed by the parties and acted upon at the Company’s 2021 annual meeting of stockholders. |
Fair Value
Fair Value | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
FAIR VALUE | NOTE 3 - FAIR VALUE: The Company measures fair value and discloses fair value measurements for financial assets. Fair value is based on the price that would be received to sell an asset 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 March 31, 2022, the assets measured at fair value are comprised of equity securities (Level 1). The fair value of held to maturity bonds as presented in note 4 was based on a Level 2 measurement. As of March 31, 2022, the carrying amounts of cash equivalents, short-term deposits and accounts payable approximate their fair values due to the short-term maturities of these instruments. As of March 31, 2022, the carrying amounts of long-term deposits approximate their fair values due to the stated interest rates which approximate market rates. The amounts funded in respect of employee rights are stated at cash surrender value which approximates its fair value. Other than items related to the asset acquisition transaction of Oravax (see note 8), there were no Level 3 items measured at fair value for the quarter ended March 31, 2021. There were no Level 3 items for the three month period ended March 31, 2022. |
Marketable Securities
Marketable Securities | 3 Months Ended |
Mar. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
MARKETABLE SECURITIES: | NOTE 4 - MARKETABLE SECURITIES: The Company’s marketable securities include investments in equity securities of D.N.A and Entera and in held to maturity bonds. a. Composition: March 31, December 31, Short-term: D.N.A (see b below) $ 974 $ 863 Entera (see c below) 336 337 Held to maturity bonds (see d below) 5,965 6,547 $ 7,275 $ 7,747 Long-term: Held to maturity bonds (see d below) $ 1,955 $ 3,875 $ 9,230 $ 11,622 b. D.N.A The D.N.A 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. As of March 31, 2022, the Company owns approximately 1.4% of D.N.A’s outstanding ordinary shares. The cost of the securities as of both March 31, 2022 and December 31, 2021 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 amortized cost and estimated fair value of held to maturity securities as of March 31, 2022, were as follows: March 31, 2022 Amortized Gross Estimated Average Short-term: Commercial bonds $ 5,892 $ (114 ) $ 5,778 1.30 % Accrued interest 73 - 73 Long-term 1,955 (52 ) 1,903 0.83 % $ 7,920 $ (166 ) $ 7,754 The amortized cost and estimated fair value of held to maturity securities as of December 31, 2021, were as follows: December 31, 2021 Amortized Gross Estimated Average yield to Short-term: Commercial bonds $ 6,432 $ (115 ) $ 6,317 1.37 % Accrued interest 115 - 115 Long-term 3,875 (29 ) 3,846 1.20 % $ 10,422 $ (144 ) $ 10,278 Held to maturity securities which will mature during the 12 months from the balance sheet date are included in short-term marketable securities. Held to maturity securities with maturity dates of more than one year are considered long-term marketable securities. |
Stockholders_ Equity
Stockholders’ Equity | 3 Months Ended |
Mar. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
STOCKHOLDERS’ EQUITY | NOTE 5 - 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 our 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 March 31, 2022, and May 12, 2022, 841,638 shares were issued under the Cantor Equity Distribution Agreement for aggregate net proceeds of $15,275. 2. On November 3, 2021, the Company entered into a securities purchase agreement with several institutional and accredited investors (the “Purchasers”), pursuant to which the Company agreed to sell, in a registered direct offering (the “Offering”), an aggregate of 2,000,000 shares of the Company’s common stock to the Purchasers for an offering price of $25.00 per share. The closing of the sale of the shares occurred on November 5, 2021. The net proceeds to the Company from the Offering, after deducting the placement agent’s fees and expenses and the Company’s Offering expenses, were approximately $46,375. 3. The following are the significant stock options transactions with employees and board members made during the three months ended March 31, 2022: a. On January 3, 2022, the Company granted an aggregate of 150,000 shares of the Company’s common stock to its President and Chief Executive Officer. The total fair value of these shares on the date of grant was $2,084, using the quoted closing market share price of $13.89 on the Nasdaq Capital Market on the date of grant. b. On January 3, 2022, the Company granted an aggregate of 207,500 RSUs representing a right to receive shares of the Company’s common stock to the Company’s employees and members of the Board of Directors as follows: 63,000 to the President and Chief Executive Officer; 42,000 to the Chief Scientific Officer; 21,000 to the Chief Operating and Business Officer, 19,000 to the Chief Financial Officer and Treasurer, 19,000 to the Chief Commercial Officer, 18,000 to the Chief Legal Officer and Secretary (effective as of the time his employment with the Company commenced on January 9, 2022), an aggregate of 24,000 to four board members and 1,500 to an employee. The RSUs will vest in four equal annual instalments on each of January 1, 2023, 2024, 2025 and 2026. The total fair value of these RSUs on the date of grant was $2,849, using the quoted closing market share price of $13.89 on the Nasdaq Capital Market on the date of grant and $12.03 for the Chief Legal Officer’s grant (equivalent to the closing price of the Company’s common stock on January 10, 2022 which represents the first trading date after his employment with the Company commenced). c. On January 3, 2022, the Company granted options to purchase an aggregate of 321,500 shares of the Company’s common stock to the Company’s employees and board members at an exercise price of $13.89 per share (equivalent to the closing price of the Company’s common stock on the date of grant) as follows: 107,000 to the President and Chief Executive Officer; 72,000 to the Chief Scientific Officer; 36,000 to the Chief Operating and Business Officer, 32,000 to the Chief Financial Officer and Treasurer and 32,000 to the Chief Commercial Officer, an aggregate of 40,000 to four board members and 2,500 to an employee. The options will vest in four equal annual instalments on each of January 1, 2023, 2024, 2025 and 2026. These options expire on January 3, 2032. The fair value of all these options on the date of grant was $2,630, using the Black Scholes option-pricing model and was based on the following assumptions: stock price of $13.89; dividend yield of 0% for all years; expected volatility of 63.05%; risk-free interest rates of 1.46%; and expected term of 6.25 years. d. On January 3, 2022, the Company granted options to purchase an aggregate of 30,000 shares of the Company’s common stock to the Company’s Chief Legal Officer and Secretary (effective as of the time his employment with the Company commenced on January 9, 2022), at an exercise price of $12.03 per share (equivalent to the closing price of the Company’s common stock on January 10, 2022 which represents the first trading date after his employment with the Company commenced). The options will vest in four equal annual instalments on each of January 1, 2023, 2024, 2025 and 2026. These options expire on January 3, 2032. The fair value of all these options on the date of grant was $214, using the Black Scholes option-pricing model and was based on the following assumptions: stock price of $12.03; dividend yield of 0% for all years; expected volatility of 63.22%; risk-free interest rates of 1.60%; and expected term of 6.25 years. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2022 | |
Leases [Abstract] | |
LEASES | NOTE 6 - LEASES The right-of-use asset and lease liability are initially measured at the present value of the lease payments, discounted using the interest rate implicit in the lease or, if that rate cannot be readily determined, the Company’s incremental borrowing rate based on the information available at the commencement date in determining the present value of the lease payments. The Company’s incremental borrowing rate is estimated to approximate the interest rate on similar terms and payments and in economic environments where the leased asset is located. The Company has various operating leases for office space and vehicles that expire through 2027. Below is a summary of our operating right-of-use assets and operating lease liabilities as of March 31, 2022 and December 31, 2021: March 31, December 31, Operating right-of-use assets $ 1,108 $ 500 Operating lease liabilities, current 237 130 Operating lease liabilities long-term 871 370 Total operating lease liabilities $ 1,108 $ 500 Lease payments for the Company’s right-of-use assets over the remaining lease periods as of March 31, 2022 and December 31, 2021 are as follows: March 31, December 31, 2022 $ 215 $ 155 2023 288 140 2024 288 140 2025 230 93 2026 137 - 2027 11 - Total undiscounted lease payments 1,169 528 Less: Interest* (61 ) (28 ) Present value of lease liabilities $ 1,108 $ 500 * Future lease payments were discounted by 3% interest rate. |
Related Party Transactions
Related Party Transactions | 3 Months Ended |
Mar. 31, 2022 | |
Related Party Transactions [Abstract] | |
RELATED PARTY TRANSACTIONS | NOTE 7 - RELATED PARTY TRANSACTIONS: On July 1, 2008, 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 ($46) and NIS 106,400 ($34), respectively. In addition to the Consulting Agreements, based on a relocation cost analysis, the Company pays 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 three months ended March 31, 2022, such relocation expenses were $143, compared to $112 for the three months ended March 31, 2021. |
Asset Acquisition Transaction
Asset Acquisition Transaction | 3 Months Ended |
Mar. 31, 2022 | |
Asset Acquisition [Abstract] | |
ASSET ACQUISITION TRANSACTION | NOTE 8 - ASSET ACQUISITION TRANSACTION On March 18, 2021, the Company entered into the Oravax License Agreement and into the Stockholders Agreement with Oravax. On that date, Oravax’s assets were (1) in process research and development of COVID-19 vaccine technology; and (2) $1,500 to be received in cash. 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, on a fully diluted basis, as of the date of issuance, for which we paid $1,500. Consequently, the Company consolidates Oravax in its consolidated financial statements since that time. In addition, under the terms of the Oravax License Agreement, the Company has licensed out to Oravax certain patent rights, know-how and information related to the Company’s oral drug delivery technology with respect to the combination with the COVID-19 vaccine technology. In consideration for the grant of the License, the Oravax License Agreement provides that the Company will receive (i) royalties equal to 7.5% on net sales, as defined in the Oravax License Agreement, of each product commercialized by Oravax, its affiliates and permitted sublicensees related to the License during the term specified in the Oravax License Agreement, (ii) sublicensing fees equal to 15% of any non-sales-based consideration received by Oravax from a permitted sublicensee and (iii) other payments ranging between $25,000 to $100,000, based on certain sales milestones being achieved by Oravax. The parties further agreed to establish a development and steering committee, which will consist of three members, of which two members will be appointed by the Company, that will oversee the ongoing research, development, clinical and regulatory activity with respect to the Oravax product. Akers contributed $1,500 in cash to Oravax and a license agreement to the Oravax product which includes a maximum of 2.5% royalties of all net sales. Effective January 1, 2022, Oravax transferred its rights and obligations under the Oravax License Agreement to its wholly-owned subsidiary, Oravax Medical Ltd. Concurrently with the execution and delivery of the Oravax License Agreement, the Company entered into the Stockholders Agreement with Akers, Premas, Cutter Mill, and Run Ridge, entities controlled by Michael Vasinikovich and Craig Schwabe, former members of Cystron Biotech LLC (“Cystron,” and collectively with Akers, Premas, Cutter Mill and Run Ridge, the “Stockholders Parties”). Pursuant to the Stockholders Agreement, among other things, the Company has the right to appoint two out of the three members to the board of directors of Oravax (the “Oravax Board”), one of which is the Company’s Chief Executive Officer who will serve as the chairman of the Oravax Board, conditioned upon the Company maintaining certain ownership thresholds. Akers has the right, until the third anniversary of the Stockholders Agreement effective date, to appoint one member to the Oravax Board. Oravax’s common stock held by the Stockholders Parties is subject to certain transfer restrictions. In addition, the Stockholders Parties have certain rights of participation in future financings as well as rights of first refusal and co-sale related to future potential transactions. Nadav Kidron, the Company’s President and Chief Executive Officer, was one of the former members of Cystron. |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2022 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENTS | NOTE 9 – SUBSEQUENT EVENTS On May 2, 2022, the Company granted 4,500 RSUs representing a right to receive shares of the Company’s common stock to Mr. Yadin Rozov, a member of the Company’s board of directors. The RSUs will vest in four equal annual instalments on each of May 2, 2023, 2024, 2025 and 2026. These RSUs expire on May 2, 2032. The total fair value of these RSUs on the date of grant was $23, using the quoted closing market share price of $5.14 on the Nasdaq Capital Market on the last trading day before the date of grant. On May 2, 2022, the Company granted options to purchase an aggregate of 7,500 shares of the Company’s common stock to Mr. Yadin Rozov, a member of the Company’s board of directors, at an exercise price of $5.14 per share (equivalent to the closing price of the Company’s common stock on the last trading day before the date of grant). The options will vest in four equal annual instalments on each of May 2, 2023, 2024, 2025 and 2026. These options expire on May 2, 2032. The fair value of all these options on the date of grant was $24, using the Black Scholes option-pricing model and was based on the following assumptions: stock price of $5.14; dividend yield of 0% for all years; expected volatility of 65.26%; risk-free interest rates of 3.03%; and expected term of 6.26 years. |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
General | a. General: 1) 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 February 17, 2006, the Company entered into an agreement with Hadasit Medical Services and Development Ltd. to acquire the provisional patent related to an orally ingestible insulin capsule to be used for the treatment of individuals with diabetes. On May 14, 2007, the Company incorporated a wholly-owned subsidiary in Israel, Oramed Ltd. (the “Subsidiary”), which is engaged in research and development. On July 30, 2019, the Subsidiary incorporated a wholly-owned subsidiary in Hong Kong, Oramed HK Limited (the “Hong Kong Subsidiary”). As of March 31, 2022, the Hong Kong Subsidiary has no operations. 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, on a fully diluted basis, 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. |
Loss per common share | b. Loss per common share Basic and diluted net loss per common share are computed by dividing the net loss for the period by the weighted average number of shares of common stock outstanding for each period. Outstanding stock options, warrants and restricted stock units (“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 3,463,525 and 5,483,784 for the three month periods ended March 31, 2022 and March 31, 2021, respectively. |
Revenue recognition | c. Revenue recognition On November 30, 2015, the Company entered into a Technology License Agreement (the “TLA”), 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”). The HTIT License Agreement and a stock purchase agreement, dated November 30, 2015, between the Company and HTIT (the “SPA”) were considered a single arrangement with multiple deliverables. The Company allocated the total consideration of $49,500 between the HTIT License Agreement and the SPA according to their fair value, as follows: $10,617 was allocated to the issuance of common stock (less issuance expenses of $23), based on the quoted price of the Company’s shares on the closing date of the SPA on December 28, 2015, and $38,883 was allocated to the HTIT License Agreement. Under Accounting Standard Codification, (“ASC”) 606, the Company identified a single performance obligation in the agreement and determined that the license and services are not distinct as the license and services are highly dependent on each other. In other words, HTIT cannot benefit from the license without the related services, and vice versa. Since the customer benefits from the services as the entity performs, revenue is recognized over time through the expected product submission date in June 2023, using the input method. The Company used the input method to measure the process for the purpose of recognizing revenue, which approximates the straight line attribution. The Company used significant judgment when it determined the product submission date. Under ASC 606, the consideration that the Company would be entitled to upon the achievement of contractual milestones, which are contingent upon the occurrence of future events, are a form of variable consideration. When assessing the portion, if any, of such milestones-related consideration to be included in the transaction price, the Company first assesses the most likely outcome for each milestone and excludes the consideration related to milestones of which the occurrence is not considered the most likely outcome. The Company then evaluates if any of the variable consideration determined in the first step is constrained by including in the transaction price variable consideration to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company used significant judgment when it determined the first step of variable consideration. The potential future royalty consideration is also considered a form of variable consideration under ASC 606 as it is based on a percentage of potential future sales of the Company’s products. However, the Company applies the sales-based royalty exception and accordingly will recognize the sales-based royalty amounts when the related sale has occurred. To date, the Company has not recognized any royalty-related revenue. As of March 31, 2022, an aggregate amount of $22,382 was allocated to the HTIT License Agreement, all of which were received through the balance sheet date. Through March 31, 2022, the Company has recognized revenue associated with this agreement in the aggregate amount of $17,005, of which $666 was recognized in the quarter ended March 31, 2022, and deferred the remaining amount of $5,377, which is presented as deferred revenues on the condensed consolidated balance sheet. |
Condensed consolidated financial statements preparation | d. 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 August 31, 2021 (the “2021 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 2021 Form 10-K. The results for interim periods are not necessarily indicative of a full fiscal year’s results. |
Recently issued accounting pronouncements, not yet adopted | e. Recently issued accounting pronouncements, not yet adopted 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 current 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 will be effective for the fiscal year beginning after December 15, 2022, including interim periods within that year. The adoption of this guidance is not expected to have a significant impact on the Company’s consolidated financial statements. |
Marketable Securities (Tables)
Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of marketable securities include investments in equity securities of D.N.A and Entera and in held to maturity bonds | March 31, December 31, Short-term: D.N.A (see b below) $ 974 $ 863 Entera (see c below) 336 337 Held to maturity bonds (see d below) 5,965 6,547 $ 7,275 $ 7,747 Long-term: Held to maturity bonds (see d below) $ 1,955 $ 3,875 $ 9,230 $ 11,622 |
Schedule of amortized cost and estimated fair value of held to maturity securities | March 31, 2022 Amortized Gross Estimated Average Short-term: Commercial bonds $ 5,892 $ (114 ) $ 5,778 1.30 % Accrued interest 73 - 73 Long-term 1,955 (52 ) 1,903 0.83 % $ 7,920 $ (166 ) $ 7,754 December 31, 2021 Amortized Gross Estimated Average yield to Short-term: Commercial bonds $ 6,432 $ (115 ) $ 6,317 1.37 % Accrued interest 115 - 115 Long-term 3,875 (29 ) 3,846 1.20 % $ 10,422 $ (144 ) $ 10,278 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Leases [Abstract] | |
Schedule of operating right-of-use assets and operating lease liabilities | March 31, December 31, Operating right-of-use assets $ 1,108 $ 500 Operating lease liabilities, current 237 130 Operating lease liabilities long-term 871 370 Total operating lease liabilities $ 1,108 $ 500 |
Schedule of lease payments for the company’s right-of-use assets over the remaining lease periods | March 31, December 31, 2022 $ 215 $ 155 2023 288 140 2024 288 140 2025 230 93 2026 137 - 2027 11 - Total undiscounted lease payments 1,169 528 Less: Interest* (61 ) (28 ) Present value of lease liabilities $ 1,108 $ 500 |
Significant Accounting Polici_2
Significant Accounting Policies (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | ||
Dec. 28, 2015 | Mar. 31, 2022 | Mar. 31, 2021 | Mar. 18, 2021 | |
Significant Accounting Policies (Details) [Line Items] | ||||
Weighted average number of common stock (in Shares) | 3,463,525 | 5,483,784 | ||
Recognized revenue aggregate amount | $ 17,005 | |||
Deferred revenue recognized | 666 | |||
Deferred revenue recognized remaining amount | 5,377 | |||
License Agreement [Member] | ||||
Significant Accounting Policies (Details) [Line Items] | ||||
Total consideration | $ 49,500 | |||
Value of common stock issued | 38,883 | $ 22,382 | ||
Stock Purchase Agreement [Member] | ||||
Significant Accounting Policies (Details) [Line Items] | ||||
Value of common stock issued | 10,617 | |||
issuance expenses | $ 23 | |||
Stockholders Agreement [Member] | ||||
Significant Accounting Policies (Details) [Line Items] | ||||
Oravax issued (in Shares) | 1,890,000 | |||
Capital stock percentage | 63.00% |
Commitments (Details)
Commitments (Details) ₪ in Thousands, $ in Thousands | Apr. 28, 2022USD ($) | Sep. 16, 2020USD ($) | Sep. 02, 2020USD ($) | Dec. 28, 2015USD ($) | Aug. 21, 2020USD ($) | Jan. 31, 2019USD ($) | Dec. 18, 2017USD ($) | Oct. 31, 2016USD ($) | Jul. 31, 2016USD ($) | Jan. 31, 2016USD ($) | Nov. 30, 2015 | Jul. 31, 2015USD ($) | Mar. 31, 2011shares | Mar. 31, 2022USD ($) | Dec. 31, 2021USD ($) | Dec. 02, 2021USD ($) | Dec. 02, 2021ILS (₪) | Feb. 15, 2011 |
Commitments (Details) [Line Items] | ||||||||||||||||||
License agreement, description | (i) royalties of 10% on net sales of the related commercialized products to be sold by HTIT in the Territory (“Royalties”), and (ii) an aggregate of $37,500, of which $3,000 was payable immediately, $8,000 will be paid subject to the Company entering into certain agreements with certain third parties, and $26,500 will be paid upon achievement of certain milestones and conditions. In the event that the Company does not meet certain conditions, the Royalties rate may be reduced to a minimum of 8%. Following the final expiration of the Company’s patents covering the technology in the Territory in 2033, the Royalties rate may be reduced, under certain circumstances, to 5%. | |||||||||||||||||
Aggregate amount | $ 20,500 | |||||||||||||||||
Initial payment | $ 3,000 | |||||||||||||||||
Payment obligation disputed | $ 6,000 | |||||||||||||||||
Deferred revenue | 2,000 | $ 2,000 | ||||||||||||||||
Stock purchase agreement with HTIT description | the Company entered into the SPA with HTIT, according to which, the Company issued 1,155,367 shares of common stock to HTIT for $12,000. The transaction closed on December 28, 2015. | |||||||||||||||||
Total consideration | 49,500 | |||||||||||||||||
Issuance of common stock | 10,617 | |||||||||||||||||
Issuance expense | 23 | |||||||||||||||||
License agreement | $ 38,883 | |||||||||||||||||
Non refundable amount | $ 500 | |||||||||||||||||
Annual lease payment | $ 137 | ₪ 435 | ||||||||||||||||
Total amount received | 2,207 | |||||||||||||||||
Liability | 169 | |||||||||||||||||
Vendor One [Member] | ||||||||||||||||||
Commitments (Details) [Line Items] | ||||||||||||||||||
Capsule ingredients amount | $ 2,905 | |||||||||||||||||
Research and development expenses | 1,592 | |||||||||||||||||
Vendor Two [Member] | ||||||||||||||||||
Commitments (Details) [Line Items] | ||||||||||||||||||
Research and development expenses | 11,337 | |||||||||||||||||
Commitments for considering service | $ 21,589 | |||||||||||||||||
Vendor Three [Member] | ||||||||||||||||||
Commitments (Details) [Line Items] | ||||||||||||||||||
Research and development expenses | $ 4,743 | |||||||||||||||||
Commitments for considering service | $ 12,343 | |||||||||||||||||
Israel Innovation Authority [Member] | ||||||||||||||||||
Commitments (Details) [Line Items] | ||||||||||||||||||
Royalty percentage | 3.00% | |||||||||||||||||
Israel Innovation Authority [Member] | Minimum [Member] | ||||||||||||||||||
Commitments (Details) [Line Items] | ||||||||||||||||||
Royalty percentage | 100.00% | |||||||||||||||||
Israel Innovation Authority [Member] | Maximum [Member] | ||||||||||||||||||
Commitments (Details) [Line Items] | ||||||||||||||||||
Royalty percentage | 150.00% | |||||||||||||||||
Royalty [Member] | ||||||||||||||||||
Commitments (Details) [Line Items] | ||||||||||||||||||
Royalty term | 15 years | |||||||||||||||||
Subsequent Event [Member] | ||||||||||||||||||
Commitments (Details) [Line Items] | ||||||||||||||||||
Fees amount | $ 850,000 | |||||||||||||||||
London Interbank Offered Rate (LIBOR) [Member] | ||||||||||||||||||
Commitments (Details) [Line Items] | ||||||||||||||||||
Total amount received | $ 2,514 | |||||||||||||||||
Milestone Two [Member] | ||||||||||||||||||
Commitments (Details) [Line Items] | ||||||||||||||||||
Milestone Payments | $ 6,500 | |||||||||||||||||
Milestones Three [Member] | ||||||||||||||||||
Commitments (Details) [Line Items] | ||||||||||||||||||
Milestone Payments | $ 4,000 | |||||||||||||||||
Milestone Four [Member] | ||||||||||||||||||
Commitments (Details) [Line Items] | ||||||||||||||||||
Milestone Payments | $ 4,000 | |||||||||||||||||
Milestone Five [Member] | ||||||||||||||||||
Commitments (Details) [Line Items] | ||||||||||||||||||
Milestone Payments | $ 3,000 | |||||||||||||||||
D.N.A [Member] | Entera Bio Ltd. [Member] | ||||||||||||||||||
Commitments (Details) [Line Items] | ||||||||||||||||||
Retaining shares (in Shares) | shares | 117,000 | |||||||||||||||||
Ownership percentage retained | 3.00% | |||||||||||||||||
Royalty percentage | 8.00% |
Marketable Securities (Details)
Marketable Securities (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Marketable Securities (Details) [Line Items] | ||
Cost of securities | $ 595 | $ 595 |
D.N.A [Member] | ||
Marketable Securities (Details) [Line Items] | ||
Ownership percentage | 1.40% | |
Entera [Member] | ||
Marketable Securities (Details) [Line Items] | ||
Cost method investment | $ 1 | |
Short-Term Marketable Securities [Member] | ||
Marketable Securities (Details) [Line Items] | ||
Held to maturity securities maturity | 12 months |
Marketable Securities (Detail_2
Marketable Securities (Details) - Schedule of marketable securities include investments in equity securities of D.N.A and Entera and in held to maturity bonds - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Marketable Securities [Line Items] | ||
Short-term | $ 7,275 | $ 7,747 |
Long-term | 9,230 | 11,622 |
Held to maturity bonds [Member] | ||
Marketable Securities [Line Items] | ||
Long-term | 1,955 | 3,875 |
D.N.A [Member] | ||
Marketable Securities [Line Items] | ||
Short-term | 974 | 863 |
Entera [Member] | ||
Marketable Securities [Line Items] | ||
Short-term | 336 | 337 |
Held to maturity bonds [Member] | ||
Marketable Securities [Line Items] | ||
Short-term | $ 5,965 | $ 6,547 |
Marketable Securities (Detail_3
Marketable Securities (Details) - Schedule of amortized cost and estimated fair value of held to maturity securities - USD ($) $ in Thousands | 3 Months Ended | 4 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Schedule of Held-to-Maturity Securities [Line Items] | ||
Amortized cost | $ 7,920 | $ 10,422 |
Gross unrealized gains (losses) | (166) | (144) |
Estimated fair value | 7,754 | 10,278 |
Commercial bonds [Member] | ||
Schedule of Held-to-Maturity Securities [Line Items] | ||
Amortized cost | 5,892 | 6,432 |
Gross unrealized gains (losses) | (114) | (115) |
Estimated fair value | $ 5,778 | $ 6,317 |
Average yield to maturity rate | 1.30% | 1.37% |
Accrued interest [Member] | ||
Schedule of Held-to-Maturity Securities [Line Items] | ||
Amortized cost | $ 73 | $ 115 |
Gross unrealized gains (losses) | ||
Estimated fair value | 73 | 115 |
Long-term [Member] | ||
Schedule of Held-to-Maturity Securities [Line Items] | ||
Amortized cost | 1,955 | 3,875 |
Gross unrealized gains (losses) | (52) | (29) |
Estimated fair value | $ 1,903 | $ 3,846 |
Average yield to maturity rate | 0.83% | 1.20% |
Stockholders_ Equity (Details)
Stockholders’ Equity (Details) - USD ($) | May 12, 2022 | Jan. 03, 2022 | Nov. 03, 2021 | Sep. 02, 2021 | Mar. 31, 2022 |
Stockholders’ Equity (Details) [Line Items] | |||||
Share-based Compensation Arrangement by Share-based Payment Award, Plan Modification, Description and Terms | the Company entered into a securities purchase agreement with several institutional and accredited investors (the “Purchasers”), pursuant to which the Company agreed to sell, in a registered direct offering (the “Offering”), an aggregate of 2,000,000 shares of the Company’s common stock to the Purchasers for an offering price of $25.00 per share. The closing of the sale of the shares occurred on November 5, 2021. The net proceeds to the Company from the Offering, after deducting the placement agent’s fees and expenses and the Company’s Offering expenses, were approximately $46,375. | ||||
Aggregate of shares of common stock | 30,000 | ||||
Total fair value (in Dollars) | $ 2,084,000 | ||||
Share price (in Dollars per share) | $ 13.89 | ||||
Expired date | Jan. 3, 2032 | ||||
Stock price (in Dollars per share) | $ 12.03 | ||||
Expected dividend yield | 0.00% | ||||
Expected volatility | 63.22% | ||||
Risk-free interest rate | 1.60% | ||||
Expected term | 6 years 3 months | ||||
Common Stock [Member] | |||||
Stockholders’ Equity (Details) [Line Items] | |||||
Common stock purchase agreement description | the Company granted options to purchase an aggregate of 321,500 shares of the Company’s common stock to the Company’s employees and board members at an exercise price of $13.89 per share (equivalent to the closing price of the Company’s common stock on the date of grant) as follows: 107,000 to the President and Chief Executive Officer; 72,000 to the Chief Scientific Officer; 36,000 to the Chief Operating and Business Officer, 32,000 to the Chief Financial Officer and Treasurer and 32,000 to the Chief Commercial Officer, an aggregate of 40,000 to four board members and 2,500 to an employee. The options will vest in four equal annual instalments on each of January 1, 2023, 2024, 2025 and 2026. These options expire on January 3, 2032. The fair value of all these options on the date of grant was $2,630, using the Black Scholes option-pricing model and was based on the following assumptions: stock price of $13.89; dividend yield of 0% for all years; expected volatility of 63.05%; risk-free interest rates of 1.46%; and expected term of 6.25 years. | ||||
Exercise price (in Dollars per share) | $ 12.03 | ||||
Chief Executive Officer [Member] | |||||
Stockholders’ Equity (Details) [Line Items] | |||||
Common stock issued to employees | 63,000 | ||||
Chief Scientific Officer [Member] | |||||
Stockholders’ Equity (Details) [Line Items] | |||||
Common stock issued to employees | 42,000 | ||||
Chief Operating and Business Officer [Member] | |||||
Stockholders’ Equity (Details) [Line Items] | |||||
Common stock issued to employees | 21,000 | ||||
Chief Financial Officer [Member] | |||||
Stockholders’ Equity (Details) [Line Items] | |||||
Common stock issued to employees | 19,000 | ||||
Chief Commercial Officer [Member] | |||||
Stockholders’ Equity (Details) [Line Items] | |||||
Common stock issued to employees | 19,000 | ||||
Chief Legal Officer [Member] | |||||
Stockholders’ Equity (Details) [Line Items] | |||||
Common stock issued to employees | 18,000 | ||||
Board of Directors Chairman [Member] | |||||
Stockholders’ Equity (Details) [Line Items] | |||||
Aggregate of shares of common stock | 24,000 | ||||
Common stock issued to employees | 1,500 | ||||
Restricted Stock Units (RSUs) [Member] | |||||
Stockholders’ Equity (Details) [Line Items] | |||||
Aggregate of shares of common stock | 207,500 | ||||
Total fair value (in Dollars) | $ 2,849 | ||||
Share price (in Dollars per share) | $ 13.89 | ||||
Expired date | Jan. 3, 2032 | ||||
Employees and Board Members [Member] | |||||
Stockholders’ Equity (Details) [Line Items] | |||||
Aggregate of shares of common stock | 150,000,000 | ||||
Granted shares | 214 | ||||
Sale Agreement [Member] | |||||
Stockholders’ Equity (Details) [Line Items] | |||||
Aggregate offering price (in Dollars) | $ 100,000,000 | ||||
Agent commission rate | 3.00% | ||||
Shares, issued | 841,638 | ||||
Sale Agreement [Member] | Forecast [Member] | |||||
Stockholders’ Equity (Details) [Line Items] | |||||
Aggregate net proceeds (in Dollars) | $ 15,275,000 | ||||
Chief Legal Officer [Member] | |||||
Stockholders’ Equity (Details) [Line Items] | |||||
Granted shares | 12.03 |
Leases (Details)
Leases (Details) | 3 Months Ended |
Mar. 31, 2022 | |
Leases [Abstract] | |
Lease term, description | The Company has various operating leases for office space and vehicles that expire through 2027. |
Future lease payments , interest rate percentage | 3.00% |
Leases (Details) - Schedule of
Leases (Details) - Schedule of operating right-of-use assets and operating lease liabilities - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Schedule of operating right-of-use assets and operating lease liabilities [Abstract] | ||
Operating right-of-use assets | $ 1,108 | $ 500 |
Operating lease liabilities, current | 237 | 130 |
Operating lease liabilities long-term | 871 | 370 |
Total operating lease liabilities | $ 1,108 | $ 500 |
Leases (Details) - Schedule o_2
Leases (Details) - Schedule of lease payments for the company’s right-of-use assets over the remaining lease periods - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 | |
Schedule of lease payments for the company’s right-of-use assets over the remaining lease periods [Abstract] | |||
2022 | $ 215 | $ 155 | |
2023 | 288 | 140 | |
2024 | 288 | 140 | |
2025 | 230 | 93 | |
2026 | 137 | ||
2027 | 11 | ||
Total undiscounted lease payments | 1,169 | 528 | |
Less: Interest* | [1] | (61) | (28) |
Present value of lease liabilities | $ 1,108 | $ 500 | |
[1] | Future lease payments were discounted by 3% interest rate. |
Related Party Transactions (Det
Related Party Transactions (Details) ₪ in Thousands, $ in Thousands | 1 Months Ended | 3 Months Ended | ||
Jul. 01, 2008USD ($) | Jul. 01, 2008ILS (₪) | Mar. 31, 2022USD ($) | Mar. 31, 2021USD ($) | |
Related Party Transactions (Details) [Line Items] | ||||
Relocation expenses | $ 143 | $ 112 | ||
Chief Executive Officer [Member] | ||||
Related Party Transactions (Details) [Line Items] | ||||
Consulting agreements fee | $ (46) | ₪ 146,705 | ||
Chief Scientific Officer [Member] | ||||
Related Party Transactions (Details) [Line Items] | ||||
Consulting agreements fee | $ (34) | ₪ 106,400 |
Asset Acquisition Transaction (
Asset Acquisition Transaction (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended |
Mar. 18, 2021 | Mar. 31, 2022 | |
Asset Acquisition Transaction (Details) [Line Items] | ||
Asset acquisitions description | On that date, Oravax’s assets were (1) in process research and development of COVID-19 vaccine technology; and (2) $1,500 to be received in cash. 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, on a fully diluted basis, as of the date of issuance, for which we paid $1,500. | |
Royalty net sales | 2.50% | |
Non-sales-based consideration | 15.00% | |
Minimum [Member] | ||
Asset Acquisition Transaction (Details) [Line Items] | ||
Other payments | $ 25,000 | |
Maximum [Member] | ||
Asset Acquisition Transaction (Details) [Line Items] | ||
Other payments | $ 100,000 | |
Oravax [Member] | ||
Asset Acquisition Transaction (Details) [Line Items] | ||
Royalty net sales | 7.50% | |
Oravax License Agreement [Member] | ||
Asset Acquisition Transaction (Details) [Line Items] | ||
license agreement | $ 1,500 |
Subsequent Events (Details)
Subsequent Events (Details) - Forecast [Member] $ / shares in Units, $ in Thousands | May 02, 2022USD ($)$ / sharesshares |
Subsequent Events (Details) [Line Items] | |
Aggregate shares of common stock, description | the Company granted options to purchase an aggregate of 7,500 shares of the Company’s common stock to Mr. Yadin Rozov, a member of the Company’s board of directors, at an exercise price of $5.14 per share (equivalent to the closing price of the Company’s common stock on the last trading day before the date of grant). The options will vest in four equal annual instalments on each of May 2, 2023, 2024, 2025 and 2026. These options expire on May 2, 2032. The fair value of all these options on the date of grant was $24, using the Black Scholes option-pricing model and was based on the following assumptions: stock price of $5.14; dividend yield of 0% for all years; expected volatility of 65.26%; risk-free interest rates of 3.03%; and expected term of 6.26 years. |
Restricted Stock Units (RSUs) [Member] | |
Subsequent Events (Details) [Line Items] | |
Aggregate of restricted stock units | shares | 4,500 |
Expired dates | May 2, 2032 |
RSUs on the date of grant | $ | $ 23 |
Market share price | $ / shares | $ 5.14 |