Document And Entity Information
Document And Entity Information - shares | 6 Months Ended | |
Feb. 28, 2021 | Apr. 13, 2021 | |
Document Information Line Items | ||
Entity Registrant Name | ORAMED PHARMACEUTICALS INC. | |
Document Type | 10-Q | |
Current Fiscal Year End Date | --08-31 | |
Entity Common Stock, Shares Outstanding | 30,228,421 | |
Amendment Flag | false | |
Entity Central Index Key | 0001176309 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Document Period End Date | Feb. 28, 2021 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Incorporation, State or Country Code | DE | |
Entity File Number | 000-50298 | |
Entity Interactive Data Current | Yes |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Feb. 28, 2021 | Aug. 31, 2020 |
CURRENT ASSETS: | ||
Cash and cash equivalents | $ 33,805 | $ 19,296 |
Short-term deposits | 13,116 | 11,060 |
Marketable securities | 9,868 | 9,544 |
Prepaid expenses and other current assets | 683 | 611 |
Total current assets | 57,472 | 40,511 |
LONG-TERM ASSETS: | ||
Long-term deposits | 2 | 2 |
Marketable securities | 3,140 | 3,928 |
Amounts funded in respect of employee rights upon retirement | 20 | 18 |
Property and equipment, net | 415 | 99 |
Operating lease right-of-use assets | 608 | 75 |
Total long-term assets | 4,185 | 4,122 |
Total assets | 61,657 | 44,633 |
CURRENT LIABILITIES: | ||
Accounts payable and accrued expenses | 3,003 | 1,699 |
Deferred revenues | 2,703 | 2,703 |
Payable to related parties | 87 | 90 |
Operating lease liabilities | 139 | 44 |
Total current liabilities | 5,932 | 4,536 |
LONG-TERM LIABILITIES: | ||
Deferred revenues | 5,606 | 6,947 |
Employee rights upon retirement | 20 | 18 |
Provision for uncertain tax position | 11 | 11 |
Operating lease liabilities | 469 | 31 |
Other liabilities | 177 | 211 |
Total long-term liabilities | 6,283 | 7,218 |
COMMITMENTS (note 2) | ||
STOCKHOLDERS’ EQUITY: | ||
Common stock, $0.012 par value (60,000,000 authorized shares; 28,289,592 and 23,675,530 shares issued and outstanding as of February 28, 2021 and August 31, 2020, respectively) | 339 | 284 |
Additional paid-in capital | 151,895 | 125,209 |
Accumulated deficit | (102,792) | (92,614) |
Total stockholders’ equity | 49,442 | 32,879 |
Total liabilities and stockholders’ equity | $ 61,657 | $ 44,633 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares | Feb. 28, 2021 | Aug. 31, 2020 |
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 | 28,289,592 | 23,675,530 |
Common stock, shares outstanding | 28,289,592 | 23,675,530 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Feb. 28, 2021 | Feb. 29, 2020 | Feb. 28, 2021 | Feb. 29, 2020 | |
Statement of Comprehensive Income [Abstract] | ||||
REVENUES | $ 665 | $ 674 | $ 1,339 | $ 1,348 |
COST OF REVENUES | ||||
RESEARCH AND DEVELOPMENT EXPENSES | 3,869 | 3,320 | 9,643 | 5,342 |
GENERAL AND ADMINISTRATIVE EXPENSES | 1,664 | 1,391 | 2,391 | 2,472 |
OPERATING LOSS | 4,868 | 4,037 | 10,695 | 6,466 |
FINANCIAL INCOME (EXPENSES), NET | 260 | 349 | 517 | 235 |
LOSS BEFORE TAXES ON INCOME | 4,608 | 3,688 | 10,178 | 6,231 |
TAXES ON INCOME | ||||
NET LOSS FOR THE PERIOD | $ 4,608 | $ 3,688 | $ 10,178 | $ 6,231 |
LOSS PER SHARE OF COMMON STOCK: | ||||
BASIC AND DILUTED LOSS PER SHARE OF COMMON STOCK (in Dollars per share) | $ 0.17 | $ 0.21 | $ 0.40 | $ 0.35 |
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING BASIC AND DILUTED LOSS PER SHARE OF COMMON STOCK (in Shares) | 27,004,268 | 17,818,429 | 25,359,960 | 17,645,372 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Changes in Stockholders’ Equity (Unaudited) - USD ($) $ in Thousands | Common Stock | Additional paid-in capital | Accumulated deficit | Total | |
BALANCE at Aug. 31, 2019 | $ 208 | $ 100,288 | $ (81,103) | $ 19,393 | |
BALANCE (in Shares) at Aug. 31, 2019 | 17,383 | ||||
ISSUANCE OF COMMON STOCK, NET | $ 5 | 2,311 | 2,316 | ||
ISSUANCE OF COMMON STOCK, NET (in Shares) | 441 | ||||
SHARES ISSUED FOR SERVICES | [1] | 30 | 30 | ||
SHARES ISSUED FOR SERVICES (in Shares) | 8 | ||||
EXERCISE OF WARRANTS AND OPTIONS | $ 1 | 12 | 13 | ||
EXERCISE OF WARRANTS AND OPTIONS (in Shares) | 12 | ||||
STOCK-BASED COMPENSATION | 569 | 569 | |||
NET LOSS | (6,231) | (6,231) | |||
BALANCE at Feb. 29, 2020 | $ 214 | 103,210 | (87,334) | 16,090 | |
BALANCE (in Shares) at Feb. 29, 2020 | 17,844 | ||||
BALANCE at Nov. 30, 2019 | $ 209 | 100,597 | (83,646) | 17,160 | |
BALANCE (in Shares) at Nov. 30, 2019 | 17,400 | ||||
ISSUANCE OF COMMON STOCK, NET | $ 5 | 2,311 | 2,316 | ||
ISSUANCE OF COMMON STOCK, NET (in Shares) | 441 | ||||
SHARES ISSUED FOR SERVICES | [1] | 13 | 13 | ||
SHARES ISSUED FOR SERVICES (in Shares) | 3 | ||||
EXERCISE OF WARRANTS AND OPTIONS | |||||
EXERCISE OF WARRANTS AND OPTIONS (in Shares) | |||||
STOCK-BASED COMPENSATION | 289 | 289 | |||
NET LOSS | (3,688) | (3,688) | |||
BALANCE at Feb. 29, 2020 | $ 214 | 103,210 | (87,334) | 16,090 | |
BALANCE (in Shares) at Feb. 29, 2020 | 17,844 | ||||
BALANCE at Aug. 31, 2020 | $ 284 | 125,209 | (92,614) | 32,879 | |
BALANCE (in Shares) at Aug. 31, 2020 | 23,675 | ||||
ISSUANCE OF COMMON STOCK, NET | $ 48 | 22,210 | 22,258 | ||
ISSUANCE OF COMMON STOCK, NET (in Shares) | 3,996 | ||||
EXERCISE OF WARRANTS AND OPTIONS | $ 7 | 3,748 | 3,755 | ||
EXERCISE OF WARRANTS AND OPTIONS (in Shares) | 618 | ||||
STOCK-BASED COMPENSATION | 728 | 728 | |||
NET LOSS | (10,178) | (10,178) | |||
BALANCE at Feb. 28, 2021 | $ 339 | 151,895 | (102,792) | 49,442 | |
BALANCE (in Shares) at Feb. 28, 2021 | 28,289 | ||||
BALANCE at Nov. 30, 2020 | $ 286 | 126,110 | (98,184) | 28,212 | |
BALANCE (in Shares) at Nov. 30, 2020 | 23,810 | ||||
ISSUANCE OF COMMON STOCK, NET | $ 46 | 21,626 | 21,672 | ||
ISSUANCE OF COMMON STOCK, NET (in Shares) | 3,861 | ||||
EXERCISE OF WARRANTS AND OPTIONS | $ 7 | 3,748 | 3,755 | ||
EXERCISE OF WARRANTS AND OPTIONS (in Shares) | 618 | ||||
STOCK-BASED COMPENSATION | 411 | 411 | |||
NET LOSS | (4,608) | (4,608) | |||
BALANCE at Feb. 28, 2021 | $ 339 | $ 151,895 | $ (102,792) | $ 49,442 | |
BALANCE (in Shares) at Feb. 28, 2021 | 28,289 | ||||
[1] | Represents an amount of less than $1. |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 6 Months Ended | |
Feb. 28, 2021 | Feb. 29, 2020 | |
CASH FLOWS FROM OPERATING ACTIVITIES: | ||
Net loss | $ (10,178) | $ (6,231) |
Adjustments required to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 30 | 2 |
Exchange differences and interest on deposits and held to maturity bonds | 515 | (17) |
Changes in fair value of investments | (351) | 121 |
Stock-based compensation | 728 | 569 |
Shares issued for services | 30 | |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (72) | 479 |
Accounts payable, accrued expenses and related parties | 1,304 | (186) |
Deferred revenues | (1,342) | (1,349) |
Liability for employee rights upon retirement | 2 | (5) |
Other liabilities | (37) | (38) |
Total net cash used in operating activities | (9,401) | (6,625) |
CASH FLOWS FROM INVESTING ACTIVITIES: | ||
Purchase of short-term deposits | (5,000) | (10,200) |
Proceeds from sale of mutual funds | 775 | |
Purchase of held to maturity securities | (4,406) | |
Proceeds from sale of short-term deposits | 2,500 | 15,000 |
Proceeds from maturity of held to maturity securities | 4,366 | 2,100 |
Funds in respect of employee rights upon retirement | 3 | |
Purchase of property and equipment | (346) | (3) |
Total net cash provided by investing activities | (2,111) | 6,900 |
CASH FLOWS FROM FINANCING ACTIVITIES: | ||
Proceeds from issuance of common stock, net of issuance costs | 22,265 | 2,316 |
Proceeds from exercise of options | 3,748 | 13 |
Total net cash provided by financing activities | 26,013 | 2,329 |
EFFECT OF EXCHANGE RATE CHANGES ON CASH | 8 | 1 |
INCREASE IN CASH AND CASH EQUIVALENTS | 14,509 | 2,605 |
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | 19,296 | 3,329 |
CASH AND CASH EQUIVALENTS AT END OF PERIOD | 33,805 | 5,934 |
(A) SUPPLEMENTARY DISCLOSURE ON CASH FLOWS - | ||
Interest received | 208 | 348 |
(B) SUPPLEMENTAL DISCLOSURE OF NON-CASH ACTIVITIES: | ||
Right of use assets and lease liabilities recognition | $ 582 |
Significant Accounting Policies
Significant Accounting Policies | 6 Months Ended |
Feb. 28, 2021 | |
Accounting Policies [Abstract] | |
SIGNIFICANT ACCOUNTING POLICIES | NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES: a. General: 1) Incorporation and operations Oramed Pharmaceuticals Inc. (collectively with its subsidiary, the “Company”, unless the context indicates otherwise) was incorporated on April 12, 2002, under the laws of the State of Nevada. From incorporation until March 3, 2006, the Company was an exploration stage company engaged in the acquisition and exploration of mineral properties. 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 March 11, 2011, the Company was reincorporated from the State of Nevada to the State of Delaware. On July 30, 2019, the Subsidiary incorporated a wholly-owned subsidiary in Hong Kong, Oramed HK Limited (the “Hong Kong Subsidiary”). As of November 30, 2020, the Hong Kong Subsidiary has no operations. HTIT Licence Agreement 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”). 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 February 28, 2021, 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. For revenue recognition policy see note 1c. In addition, on November 30, 2015, the Company entered into a Stock Purchase Agreement with HTIT (the “SPA”). According to the SPA, the Company issued 1,155,367 shares of common stock to HTIT for $12,000. The transaction closed on December 28, 2015. 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 License Agreement. 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 revenues in each of the consolidated balance sheets as of February 28, 2021 and for the fiscal years ended August 31, 2020 and 2019. 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. 2) 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. 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 5,338,751 and 4,736,787 for the six month periods ended February 28, 2021 and February 29, 2020, respectively, and 5,401,269 and 4,840,417 for the three month periods ended February 28, 2021 and February 29, 2020, respectively. c. Revenue recognition The License Agreement and the SPA were considered a single arrangement with multiple deliverables. The Company allocated the total consideration of $49,500 between the 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 License Agreement. On September 1, 2018, the Company adopted Accounting Standards Update (“ASU”) 2014-09 “Revenue from Contracts with Customers (Topic 606)” (“ASC 606”), using the modified retrospective method of adoption. Under this method, the Company applied Accounting Standards Codification (“ASC”) 606 to the License Agreement at the adoption date and was required to make an adjustment to the September 1, 2018 opening accumulated deficit balance and all prior periods continue to be presented under ASC 605. The most significant impact from adopting ASC 606 was the impact of the timing of recognition of revenue associated with the milestone payment. Under ASC 606, the Company is required to recognize the total transaction price (which includes consideration related to milestones once the criteria for recognition have been satisfied) using the input method over the period the performance obligation is fulfilled. Accordingly, once the consideration associated with a milestone is included in the transaction price, incremental revenue is recognized immediately based on the period of time that has elapsed towards complete satisfaction of the performance obligation. Under 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. Amounts that were allocated to the HTIT License Agreement as of February 28, 2021 aggregated $22,382, all of which were received through the balance sheet date. Through February 28, 2021, the Company has recognized revenue associated with this agreement in the aggregate amount of $14,073, of which $666 was recognized in the quarter ended February 28, 2021, and deferred the remaining amount of $8,309 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, 2020 (the “2020 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 2020 Form 10-K. The results for interim periods are not necessarily indicative of a full fiscal year’s results. e. Recently adopted standards In February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-02, “Leases (Topic 842)”, which supersedes the existing guidance for lease accounting, Leases (Topic 840). The new standard requires a lessee to record assets and liabilities on its balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the lessee’s income statement. The Company adopted this standard as of September 1, 2019 on a modified retrospective basis and will not restate comparative periods. The Company elected the package of practical expedients permitted under the transition guidance within the new standard which, among other things, allows the Company to carry forward the historical lease classification. The Company made an accounting policy election to keep leases with an initial term of 12 months or less off of its balance sheet. The Company recognized those lease payments in its statements of operations on a straight-line basis over the lease period. As of the adoption date, the Company recognized an operating lease asset and liability of $168 and $168, respectively, as of September 1, 2019 on its balance sheet. f. Standards issued but not yet adopted In June 2016, the FASB issued ASU 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 will not have a significant impact on the Company’s consolidated financial statements. |
Commitments
Commitments | 6 Months Ended |
Feb. 28, 2021 | |
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 right, title and interest in and to a certain patent application related to the oral administration of proteins that it has licensed to Entera since August 2010. Under this agreement, the Subsidiary is entitled to receive from Entera royalties of 3% of Entera’s net revenues (as defined in the agreement) and a license back of that patent application for use in respect of diabetes and influenza. As of February 28, 2021, 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 (the “Amgen License”) with Amgen related to the research of inflammatory disease and other serious illnesses. As reported by Entera, under the terms of the Amgen License, Entera will receive a modest initial technology access fee from Amgen and will be responsible for preclinical development at Amgen’s expense. Entera will be eligible to receive up to $270,000 in aggregate payments, as well as tiered royalties up to mid-single digits, upon achievement of various clinical and commercial milestones if Amgen decides to move all of these programs forward. Amgen is responsible for clinical development, manufacturing and commercialization of any of the resulting programs. To the extent the Amgen License results in net revenues as defined in the Patent Transfer Agreement, the Subsidiary will be entitled to the aforementioned royalties. In addition, 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. 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 $1,542 was recognized in research and development expenses through February 28, 2021. c. On August 2, 2020, the Subsidiary entered into a lease agreement for its facilities in Israel. The lease agreement is for 263 sqm and is for a period of 60 months commencing September 1, 2020. The Company has the option to extend the period by another 60 months. The annual lease payment, including management fee, is NIS 435,000 ($133). As security for its obligation under this lease agreement, the Company provided a bank guarantee in an amount equal to three monthly lease payments. 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 $3,512 was recognized in research and development expenses through February 28, 2021. 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 $1,561 was recognized in research and development expenses through February 28, 2021. f. 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 that was received through February 28, 2021 was $2,207 ($2,490 including interest). g. Grants from the European Commission (“EC”) During fiscal year 2020, the Company received an aggregate payment of €50 from the EC under The European Innovation Council Accelerator (previously known as SME Instrument) of the European Innovation Programme Horizon 2020. As part of the grant terms, the Company is required to use the proceeds from the grant in Europe. The Company intends on using the grant to explore the possibility of running clinical trials in Europe. |
Fair Value
Fair Value | 6 Months Ended |
Feb. 28, 2021 | |
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 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 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 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 February 28, 2021, 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 February 28, 2021, 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 February 28, 2021, 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. There were no Level 3 items for the three month periods ended February 28, 2021 and February 29, 2020. |
Marketable Securities
Marketable Securities | 6 Months Ended |
Feb. 28, 2021 | |
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, held to maturity bonds, fair value through profit and loss, preferred equity and mutual funds. a. Composition: February 28, 2021 August 31, Short-term: D.N.A (see b below) $ 553 $ 246 Entera (see c below) 194 150 Held to maturity bonds (see d below) 6,120 5,369 Preferred equity - 481 Mutual funds* 3,001 3,298 $ 9,868 $ 9,544 Long-term: Held to maturity bonds (see d below) $ 3,140 $ 3,928 13,008 $ 13,472 * Mutual funds include equity funds only 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 February 28, 2021, the Company owns approximately 1.9% of D.N.A’s outstanding ordinary shares. The cost of the securities as of February 28, 2021 and August 31, 2020 is $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 February 28, 2021, are as follows: February 28, 2021 Amortized Gross unrealized Estimated Average yield to Short-term: Commercial bonds $ 6,049 $ (76 ) $ 5,973 2.06 % Accrued interest 71 - 71 Long-term 3,140 7 3,147 1.57 % $ 9,260 $ (69 ) $ 9,191 The amortized cost and estimated fair value of held-to-maturity securities as of August 31, 2020, are as follows: August 31, 2020 Amortized Gross unrealized Estimated Average yield to Short-term: Commercial bonds $ 5,295 $ (29 ) $ 5,266 2.26 % Accrued interest 74 - 74 Long-term 3,928 56 3,984 2.20 % $ 9,297 $ 27 $ 9,324 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 | 6 Months Ended |
Feb. 28, 2021 | |
Stockholders' Equity Note [Abstract] | |
STOCKHOLDERS' EQUITY | NOTE 5 - STOCKHOLDERS’ EQUITY: 1. On September 5, 2019, the Company entered into an Equity Distribution Agreement (the “Sales Agreement”), pursuant to which the Company could, from time to time and at the Company’s option, issue and sell shares of Company common stock having an aggregate offering price of up to $15,000, through a sales agent, subject to certain terms and conditions. Any shares sold would be sold pursuant to the Company’s effective shelf registration statement on Form S-3 including a prospectus and prospectus supplement, each dated February 10, 2020 (which superseded a prior registration statement, prospectus and prospectus supplement that related to shares sold under the Sales Agreement). 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 Sales Agreement. As of February 28, 2021, 3,212,621 shares were issued under the Sales Agreement for aggregate net proceeds of $14,397. 2. On February 27, 2020, the Company entered into an underwriting agreement (“Agreement”) with National Securities Corporation (“Underwriter”), in connection with a public offering (“Offering”) of 5,250,000 shares of the Company’s common stock, at an offering price of $4.00 per share. Under the terms of the Agreement, the Company granted the Underwriter a 45-day option to purchase from the Company up to an additional 787,500 shares of common stock at the public offering price (“Over-Allotment Option”). In connection with the Offering, the Company also agreed to issue to the Underwriter, or its designees, warrants (“Underwriter’s Warrants”), to purchase up to an aggregate of 7% of the shares of common stock sold in the Offering (including any additional shares sold during the 45-day option period), at an exercise price of $4.80 per share. The Underwriter’s Warrants issued in the Offering will be exercisable at any time and from time to time, in whole or in part, commencing six months from issuance for a period of three years from the date of issuance. The closing of the sale of the Offering occurred on March 2, 2020. On April 9, 2020, the Company issued 180,561 shares of Common Stock and 12,640 Underwriter’s Warrants pursuant to a partial exercise by the Underwriter of the Over-Allotment Option (“Partial Over-Allotment Option Exercise”). The net proceeds to the Company from the Offering, including from the Partial Over-Allotment Option Exercise, after deducting the underwriting discount and the Company’s estimated Offering expenses were $19,894. 3. On December 1, 2020, the Company entered into a new equity distribution agreement (the “New Sales Agreement”), pursuant to which the Company may, from time to time and at the Company’s option, issue and sell shares of Company common stock having an aggregate offering price of up to $40,000, 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 February 10, 2020 and prospectus supplement dated December 1, 2020. The Company will pay 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 New Sales Agreement. As of February 28, 2021, 1,623,114 shares were issued under the New Sales Agreement for aggregate net proceeds of $11,852. As of April 13, 2021, 3,152,093 shares were issued under the New Sales Agreement for aggregate net proceeds of $27,653. 4. The following are the non-performance based stock option grants made by the Company to the Company's employees and board members during the six months ended February 28, 2021: a. On February 3, 2021, the Company granted options to purchase an aggregate of 340,000 shares of common stock of the Company at an exercise price of $10.40 per share (equivalent to the closing price of the Company’s common stock on the date of grant) as follows: 150,000 to the President and Chief Executive Officer; 100,000 to the Chief Scientific Officer; 50,000 to the Chief Operating Officer and 40,000 to the Chief Financial Officer, Treasurer and Secretary. The options will vest in four equal annual instalments on each of December 31, 2021, 2022, 2023 and 2024. These options expire on February 3, 2031. The fair value of all these options on the date of grant was $1,987, using the Black Scholes option-pricing model and was based on the following assumptions: stock price of $10.40; dividend yield of 0% for all years; expected volatility of 61.07%; risk-free interest rates of 0.64%; and expected term of 6.21 years. b. On February 17, 2021, the Company granted options to purchase an aggregate of 15,000 shares of common stock of the Company at an exercise price of $11.33 per share (equivalent to the closing price of the Company’s common stock on the date of grant) to Kevin Rakin, one of the Company’s Board members. The options will vest in three equal annual instalments on each of December 31, 2021, 2022, and 2023. These options expire on February 17, 2031. The fair value of all these options on the date of grant was $100, using the Black Scholes option-pricing model and was based on the following assumptions: stock price of $11.33; dividend yield of 0% for all years; expected volatility of 64.39%; risk-free interest rates of 1.67%; and expected term of 5.94 years. |
Leases
Leases | 6 Months Ended |
Feb. 28, 2021 | |
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 date of adoption 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 2025. Below is a summary of our operating right-of-use assets and operating lease liabilities as of February 28, 2021: February 28, Operating right-of-use assets $ 608 Operating lease liabilities, current 139 Operating lease liabilities long-term 469 Total operating lease liabilities $ 608 For more information about our office lease terms, please see note 2(c). Minimum lease payments for the Company’s right-of-use assets over the remaining lease periods as of February 28, 2021 are as follows: February 28, 2021 $ 84 2022 165 2023 135 2024 133 2025 133 Total undiscounted lease payments 650 Less: Interest* 42 Present value of lease liabilities $ 608 * Future lease payments were discounted by 3% interest rate. |
Related Parties - Transactions
Related Parties - Transactions | 6 Months Ended |
Feb. 28, 2021 | |
Related Party Transactions [Abstract] | |
RELATED PARTIES - TRANSACTIONS | NOTE 7 - RELATED PARTIES - 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 (the “CSO”), whereby the Chief Executive Officer (the “CEO”) and the CSO, 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 CEO and the CSO is NIS 127,570 ($39) and NIS 92,522 ($28), respectively. In addition to the Consulting Agreements, based on a relocation cost analysis prepared by consulting company ORI - Organizational Resources International Ltd., the Company pays for certain direct costs, related taxes and expenses incurred in connection with the relocation of the CEO to U.S. During the six months ended February 28, 2021, such relocation expenses totalled $180, compared to $298 for the six months ended February 29, 2020. |
Subsequent Event
Subsequent Event | 6 Months Ended |
Feb. 28, 2021 | |
Subsequent Events [Abstract] | |
SUBSEQUENT EVENT | NOTE 8 – SUBSEQUENT EVENT: 1. Oravax License Agreement On March 18, 2021, the Company, entered into a License Agreement (the “Oravax License Agreement”) with Oravax Medical Inc. (“Oravax”), pursuant to which the Company will grant to Oravax an exclusive, worldwide license (the “License”) under the Company’s rights in certain patents and related intellectual property in which Oravax will receive certain rights relating to the Company’s proprietary oral delivery technology to further develop, manufacture and commercialize oral vaccines for COVID-19 and other novel coronaviruses based on Premas Biotech Pvt.’s (“Premas”) proprietary vaccine technology involving a triple antigen virus like particle (the “Oravax Product”) which was previously owned by Cystron Biotech LLC (“Cystron”), and later acquired by Akers Biosciences Inc. (“Akers”). 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. In addition, the Company agreed to buy and Oravax agreed to issue to the Company 1,890,000 shares of common stock of Oravax, representing 63% of the common stock of Oravax for the aggregate amount of $1,500. Akers agreed to contribute to Oravax $1,500 in cash and substantially all of the assets of Cystron, including a license agreement to the Premas novel vaccine technology. The company is evaluating the nature of the transaction for accounting purposes. 2. Oravax Stockholders Agreement Concurrently with the execution and delivery of the Oravax License Agreement, the Company entered into a Stockholders Agreement (the “Stockholders Agreement”), with Akers, Premas, Cutter Mill Capital LLC (“Cutter Mill”), and Run Ridge LLC (“Run Ridge”), entities controlled by Michael Vasinikovich and Craig Schwabe, former members of Cystron, and collectively with Akers, Premas, Cutter Mill and Run Ridge, the Stockholders Parties. Pursuant to the Stockholders Agreement, among other things, the Company will have 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 will have 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 will be subject to certain transfer restrictions. In addition, the Stockholders Parties will have certain rights of participation in future financings as well as rights of first refusal and co-sale related to future potential transactions. |
Accounting Policies, by Policy
Accounting Policies, by Policy (Policies) | 6 Months Ended |
Feb. 28, 2021 | |
Accounting Policies [Abstract] | |
General | a. General: 1) Incorporation and operations Oramed Pharmaceuticals Inc. (collectively with its subsidiary, the “Company”, unless the context indicates otherwise) was incorporated on April 12, 2002, under the laws of the State of Nevada. From incorporation until March 3, 2006, the Company was an exploration stage company engaged in the acquisition and exploration of mineral properties. 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 March 11, 2011, the Company was reincorporated from the State of Nevada to the State of Delaware. On July 30, 2019, the Subsidiary incorporated a wholly-owned subsidiary in Hong Kong, Oramed HK Limited (the “Hong Kong Subsidiary”). As of November 30, 2020, the Hong Kong Subsidiary has no operations. HTIT Licence Agreement 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”). 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 February 28, 2021, 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. For revenue recognition policy see note 1c. In addition, on November 30, 2015, the Company entered into a Stock Purchase Agreement with HTIT (the “SPA”). According to the SPA, the Company issued 1,155,367 shares of common stock to HTIT for $12,000. The transaction closed on December 28, 2015. 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 License Agreement. 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 revenues in each of the consolidated balance sheets as of February 28, 2021 and for the fiscal years ended August 31, 2020 and 2019. 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. 2) 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. |
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 5,338,751 and 4,736,787 for the six month periods ended February 28, 2021 and February 29, 2020, respectively, and 5,401,269 and 4,840,417 for the three month periods ended February 28, 2021 and February 29, 2020, respectively. |
Revenue recognition | c. Revenue recognition The License Agreement and the SPA were considered a single arrangement with multiple deliverables. The Company allocated the total consideration of $49,500 between the 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 License Agreement. On September 1, 2018, the Company adopted Accounting Standards Update (“ASU”) 2014-09 “Revenue from Contracts with Customers (Topic 606)” (“ASC 606”), using the modified retrospective method of adoption. Under this method, the Company applied Accounting Standards Codification (“ASC”) 606 to the License Agreement at the adoption date and was required to make an adjustment to the September 1, 2018 opening accumulated deficit balance and all prior periods continue to be presented under ASC 605. The most significant impact from adopting ASC 606 was the impact of the timing of recognition of revenue associated with the milestone payment. Under ASC 606, the Company is required to recognize the total transaction price (which includes consideration related to milestones once the criteria for recognition have been satisfied) using the input method over the period the performance obligation is fulfilled. Accordingly, once the consideration associated with a milestone is included in the transaction price, incremental revenue is recognized immediately based on the period of time that has elapsed towards complete satisfaction of the performance obligation. Under 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. Amounts that were allocated to the HTIT License Agreement as of February 28, 2021 aggregated $22,382, all of which were received through the balance sheet date. Through February 28, 2021, the Company has recognized revenue associated with this agreement in the aggregate amount of $14,073, of which $666 was recognized in the quarter ended February 28, 2021, and deferred the remaining amount of $8,309 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, 2020 (the “2020 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 2020 Form 10-K. The results for interim periods are not necessarily indicative of a full fiscal year’s results. |
Recently adopted standards | e. Recently adopted standards In February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-02, “Leases (Topic 842)”, which supersedes the existing guidance for lease accounting, Leases (Topic 840). The new standard requires a lessee to record assets and liabilities on its balance sheet for all leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the lessee’s income statement. The Company adopted this standard as of September 1, 2019 on a modified retrospective basis and will not restate comparative periods. The Company elected the package of practical expedients permitted under the transition guidance within the new standard which, among other things, allows the Company to carry forward the historical lease classification. The Company made an accounting policy election to keep leases with an initial term of 12 months or less off of its balance sheet. The Company recognized those lease payments in its statements of operations on a straight-line basis over the lease period. As of the adoption date, the Company recognized an operating lease asset and liability of $168 and $168, respectively, as of September 1, 2019 on its balance sheet. |
Standards issued but not yet adopted | f. Standards issued but not yet adopted In June 2016, the FASB issued ASU 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 will not have a significant impact on the Company’s consolidated financial statements. |
Marketable Securities (Tables)
Marketable Securities (Tables) | 6 Months Ended |
Feb. 28, 2021 | |
Investments, Debt and Equity Securities [Abstract] | |
Schedule of marketable securities include investments in equity securities | February 28, 2021 August 31, Short-term: D.N.A (see b below) $ 553 $ 246 Entera (see c below) 194 150 Held to maturity bonds (see d below) 6,120 5,369 Preferred equity - 481 Mutual funds* 3,001 3,298 $ 9,868 $ 9,544 Long-term: Held to maturity bonds (see d below) $ 3,140 $ 3,928 13,008 $ 13,472 * Mutual funds include equity funds only |
Schedule of amortized cost and estimated fair value of held-to-maturity securities | February 28, 2021 Amortized Gross unrealized Estimated Average yield to Short-term: Commercial bonds $ 6,049 $ (76 ) $ 5,973 2.06 % Accrued interest 71 - 71 Long-term 3,140 7 3,147 1.57 % $ 9,260 $ (69 ) $ 9,191 August 31, 2020 Amortized Gross unrealized Estimated Average yield to Short-term: Commercial bonds $ 5,295 $ (29 ) $ 5,266 2.26 % Accrued interest 74 - 74 Long-term 3,928 56 3,984 2.20 % $ 9,297 $ 27 $ 9,324 |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Feb. 28, 2021 | |
Leases [Abstract] | |
Schedule of operating right-of-use assets and operating lease liabilities | February 28, Operating right-of-use assets $ 608 Operating lease liabilities, current 139 Operating lease liabilities long-term 469 Total operating lease liabilities $ 608 |
Schedule of minimum lease payments for the company’s right-of-use assets | February 28, 2021 $ 84 2022 165 2023 135 2024 133 2025 133 Total undiscounted lease payments 650 Less: Interest* 42 Present value of lease liabilities $ 608 |
Significant Accounting Polici_2
Significant Accounting Policies (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||||||
Aug. 21, 2020 | Dec. 28, 2015 | Nov. 30, 2015 | Feb. 28, 2021 | Feb. 29, 2020 | Feb. 28, 2021 | Feb. 29, 2020 | Aug. 31, 2020 | Sep. 01, 2019 | Jul. 31, 2015 | |
Significant Accounting Policies (Details) [Line Items] | ||||||||||
Royalty term | 15 years | |||||||||
Milestone payment received | $ 20,500 | |||||||||
Non-refundable amount | $ 500 | |||||||||
Milestone payment, description | 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. | |||||||||
Antidilutive Securities Excluded from Computation of Earnings Per Share, Amount (in Shares) (in Shares) | 5,401,269 | 4,840,417 | 5,338,751 | 4,736,787 | ||||||
Operating lease asset | $ 608 | $ 608 | $ 75 | $ 168 | ||||||
Operating lease liability | $ 168 | |||||||||
Stock Purchase Agreement [Member] | ||||||||||
Significant Accounting Policies (Details) [Line Items] | ||||||||||
Number of common stock issued | $ 10,617 | |||||||||
issuance expenses | 23 | |||||||||
License Agreement [Member] | ||||||||||
Significant Accounting Policies (Details) [Line Items] | ||||||||||
Number of common stock issued | 38,883 | $ 22,382 | ||||||||
Total consideration | $ 49,500 | |||||||||
HTIT [Member] | ||||||||||
Significant Accounting Policies (Details) [Line Items] | ||||||||||
Percentages of royalties on net sales | 10.00% | |||||||||
Aggregate license cost | $ 37,500 | |||||||||
License costs payable | 3,000 | 3,000 | ||||||||
Amount paid subject to the Company entering into certain agreements | 8,000 | 8,000 | ||||||||
Payable upon achievement of certain milestones and conditions | $ 26,500 | $ 26,500 | ||||||||
Royalty commitment description | 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%. | |||||||||
Milestone payment, description | 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 revenues in each of the consolidated balance sheets as of February 28, 2021 and for the fiscal years ended August 31, 2020 and 2019. 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. | |||||||||
HTIT [Member] | Stock Purchase Agreement [Member] | ||||||||||
Significant Accounting Policies (Details) [Line Items] | ||||||||||
Number of common stock issued (in Shares) | 1,155,367 | |||||||||
Number of common stock issued | $ 12,000 |
Commitments (Details)
Commitments (Details) - USD ($) $ in Thousands | Sep. 16, 2020 | Sep. 02, 2020 | Aug. 02, 2020 | Dec. 11, 2018 | Mar. 31, 2011 | Dec. 18, 2017 | Feb. 28, 2021 | Feb. 15, 2011 |
Commitments (Details) [Line Items] | ||||||||
Aggregate payments receive | $ 270,000 | |||||||
Total amount received | $ 2,207 | |||||||
Total amount received including interest | $ 2,490 | |||||||
Grants from the European Commission, description | During fiscal year 2020, the Company received an aggregate payment of €50 from the EC under The European Innovation Council Accelerator (previously known as SME Instrument) of the European Innovation Programme Horizon 2020. | |||||||
Vendor Two [Member] | ||||||||
Commitments (Details) [Line Items] | ||||||||
Expense which was recognized | $ 3,512 | |||||||
Commitments for consulting services | $ 21,589 | |||||||
Vendor Three [Member] | ||||||||
Commitments (Details) [Line Items] | ||||||||
Expense which was recognized | 1,561 | |||||||
Commitments for consulting services | $ 12,343 | |||||||
Vendor One [Member] | ||||||||
Commitments (Details) [Line Items] | ||||||||
Commitments for consulting services | $ 2,905 | |||||||
Expense which was recognized | $ 1,542 | |||||||
Office Facilities [Member] | ||||||||
Commitments (Details) [Line Items] | ||||||||
Lessee, description | The lease agreement is for 263 sqm and is for a period of 60 months commencing September 1, 2020. The Company has the option to extend the period by another 60 months. The annual lease payment, including management fee, is NIS 435,000 ($133). | |||||||
Entera Bio Ltd. [Member] | D.N.A [Member] | ||||||||
Commitments (Details) [Line Items] | ||||||||
Ordinary shares after stock split (in Shares) | 117,000 | |||||||
Ownership percentage retained | 3.00% | |||||||
Royalty percentage | 8.00% | |||||||
Israel Innovation Authority [Member] | ||||||||
Commitments (Details) [Line Items] | ||||||||
Royalty percentage | 3.00% | |||||||
Israel Innovation Authority [Member] | Minimum [Member] | ||||||||
Commitments (Details) [Line Items] | ||||||||
Royalty percentage | 100.00% | |||||||
Israel Innovation Authority [Member] | Maximum [Member] | ||||||||
Commitments (Details) [Line Items] | ||||||||
Royalty percentage | 150.00% |
Marketable Securities (Details)
Marketable Securities (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Feb. 28, 2021 | Aug. 31, 2020 | |
Investments, Debt and Equity Securities [Abstract] | ||
Percentage of ownership interest | 1.90% | |
Cost of securities | $ 595 | $ 595 |
Cost method investment | $ 1 | |
Marketable securities maturity, term | 12 months |
Marketable Securities (Detail_2
Marketable Securities (Details) - Schedule of marketable securities include investments in equity securities - USD ($) $ in Thousands | Feb. 28, 2021 | Aug. 31, 2020 | |
Schedule of marketable securities include investments in equity securities [Abstract] | |||
D.N.A (see b below) | $ 553 | $ 246 | |
Entera (see c below) | 194 | 150 | |
Held to maturity bonds (see d below) | 6,120 | 5,369 | |
Preferred equity | 481 | ||
Mutual funds | [1] | 3,001 | 3,298 |
Marketable securities | 9,868 | 9,544 | |
Long-term: | |||
Held to maturity bonds (see d below) | 3,140 | 3,928 | |
Total marketable securities, noncurrent | $ 13,008 | $ 13,472 | |
[1] | Mutual funds include equity funds only |
Marketable Securities (Detail_3
Marketable Securities (Details) - Schedule of amortized cost and estimated fair value of held-to-maturity securities - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Feb. 28, 2021 | Aug. 31, 2020 | |
Short-term: | ||
Amortized cost | $ 9,260 | $ 9,297 |
Gross unrealized gains (losses) | (69) | 27 |
Estimated fair value | 9,191 | 9,324 |
Short-term [Member] | Commercial bonds [Member] | ||
Short-term: | ||
Amortized cost | 6,049 | 5,295 |
Gross unrealized gains (losses) | (76) | (29) |
Estimated fair value | $ 5,973 | $ 5,266 |
Average yield to maturity rate | 2.06% | 2.26% |
Short-term [Member] | Accrued interest [Member] | ||
Short-term: | ||
Amortized cost | $ 71 | $ 74 |
Gross unrealized gains (losses) | ||
Estimated fair value | 71 | 74 |
Long-term [Member] | ||
Short-term: | ||
Amortized cost | 3,140 | 3,928 |
Gross unrealized gains (losses) | 7 | 56 |
Estimated fair value | $ 3,147 | $ 3,984 |
Average yield to maturity rate | 1.57% | 2.20% |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | Apr. 13, 2021 | Feb. 03, 2021 | Dec. 02, 2020 | Sep. 05, 2019 | Feb. 17, 2021 | Feb. 27, 2020 | Feb. 28, 2021 |
Stockholders' Equity (Details) [Line Items] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Plan Modification, Description and Terms | the Company entered into an underwriting agreement (“Agreement”) with National Securities Corporation (“Underwriter”), in connection with a public offering (“Offering”) of 5,250,000 shares of the Company’s common stock, at an offering price of $4.00 per share. Under the terms of the Agreement, the Company granted the Underwriter a 45-day option to purchase from the Company up to an additional 787,500 shares of common stock at the public offering price (“Over-Allotment Option”). In connection with the Offering, the Company also agreed to issue to the Underwriter, or its designees, warrants (“Underwriter’s Warrants”), to purchase up to an aggregate of 7% of the shares of common stock sold in the Offering (including any additional shares sold during the 45-day option period), at an exercise price of $4.80 per share. The Underwriter’s Warrants issued in the Offering will be exercisable at any time and from time to time, in whole or in part, commencing six months from issuance for a period of three years from the date of issuance. The closing of the sale of the Offering occurred on March 2, 2020. On April 9, 2020, the Company issued 180,561 shares of Common Stock and 12,640 Underwriter’s Warrants pursuant to a partial exercise by the Underwriter of the Over-Allotment Option (“Partial Over-Allotment Option Exercise”). The net proceeds to the Company from the Offering, including from the Partial Over-Allotment Option Exercise, after deducting the underwriting discount and the Company’s estimated Offering expenses were $19,894. | ||||||
Sale agreement [Member] | |||||||
Stockholders' Equity (Details) [Line Items] | |||||||
Aggregate offering price (in Dollars) | $ 15,000 | ||||||
Agent commission rate | 3.00% | ||||||
Shares, Issued | 3,212,621 | ||||||
Aggregate net proceeds (in Dollars) | $ 14,397 | ||||||
New sales agreement [Member] | |||||||
Stockholders' Equity (Details) [Line Items] | |||||||
Aggregate offering price (in Dollars) | $ 40,000 | ||||||
Agent commission rate | 3.00% | ||||||
Shares, Issued | 1,623,114 | ||||||
Aggregate net proceeds (in Dollars) | $ 11,852 | ||||||
New sales agreement [Member] | Subsequent Event [Member] | |||||||
Stockholders' Equity (Details) [Line Items] | |||||||
Shares, Issued | 3,152,093 | ||||||
Aggregate net proceeds (in Dollars) | $ 27,653 | ||||||
Employees and Board members [Member] | |||||||
Stockholders' Equity (Details) [Line Items] | |||||||
Options granted | 340,000 | 15,000 | |||||
Exercise price (in Dollars per share) | $ 10.40 | $ 11.33 | |||||
Expiration date | Feb. 3, 2031 | Feb. 17, 2031 | |||||
Fair value of options granted (in Dollars) | $ 1,987 | $ 100 | |||||
Stock price (in Dollars per share) | $ 10,400 | $ 11.33 | |||||
Expected dividend yield | 0.00% | 0.00% | |||||
Expected volatility | 61.07% | 64.39% | |||||
Risk-free interest rate | 0.64% | 1.67% | |||||
Expected term | 6 years 76 days | 5 years 343 days | |||||
Vesting, description | The options will vest in four equal annual instalments on each of December 31, 2021, 2022, 2023 and 2024. | The options will vest in three equal annual instalments on each of December 31, 2021, 2022, and 2023. | |||||
President and Chief Executive Officer [Member] | |||||||
Stockholders' Equity (Details) [Line Items] | |||||||
Options granted | 150,000 | ||||||
Chief Scientific Officer [Member] | |||||||
Stockholders' Equity (Details) [Line Items] | |||||||
Options granted | 100,000 | ||||||
Chief Operating Officer [Member] | |||||||
Stockholders' Equity (Details) [Line Items] | |||||||
Options granted | 50,000 | ||||||
Chief Financial Officer [Member] | |||||||
Stockholders' Equity (Details) [Line Items] | |||||||
Options granted | 40,000 |
Leases (Details)
Leases (Details) | 6 Months Ended |
Feb. 28, 2021 | |
Disclosure Text Block [Abstract] | |
Lease term, description | The Company has various operating leases for office space and vehicles that expire through 2025. |
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 $ in Thousands | Feb. 28, 2021USD ($) |
Schedule of operating right-of-use assets and operating lease liabilities [Abstract] | |
Operating right-of-use assets | $ 608 |
Operating lease liabilities, current | 139 |
Operating lease liabilities long-term | 469 |
Total operating lease liabilities | $ 608 |
Leases (Details) - Schedule o_2
Leases (Details) - Schedule of minimum lease payments for the company’s right-of-use assets $ in Thousands | Feb. 28, 2021USD ($) | |
Schedule of minimum lease payments for the company’s right-of-use assets [Abstract] | ||
2021 | $ 84 | |
2022 | 165 | |
2023 | 135 | |
2024 | 133 | |
2025 | 133 | |
Total undiscounted lease payments | 650 | |
Less: Interest | 42 | [1] |
Present value of lease liabilities | $ 608 | |
[1] | Future lease payments were discounted by 3% interest rate. |
Related Parties - Transactions
Related Parties - Transactions (Details) - Chief Executive Officer [Member] - USD ($) | 1 Months Ended | 6 Months Ended | |
Jul. 01, 2008 | Feb. 28, 2021 | Feb. 29, 2020 | |
Related Parties - Transactions (Details) [Line Items] | |||
Consulting agreements, description | 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 CEO and the CSO is NIS 127,570 ($39) and NIS 92,522 ($28), respectively. | ||
Relocation expenses | $ 180 | $ 298 |
Subsequent Event (Details)
Subsequent Event (Details) - Subsequent Event [Member] - Oravax License Agreement [Member] | Mar. 18, 2021USD ($)shares |
Subsequent Event (Details) [Line Items] | |
Percentages of royalties on net sales | 7.50% |
Sublicensing fees percentage | 15.00% |
Number of common stock issued (in Shares) | shares | 1,890,000 |
Aggregate of common stock percentage | 63.00% |
Number of common stock issued | $ 1,500 |
Cash contributed | 1,500 |
Minimum [Member] | |
Subsequent Event (Details) [Line Items] | |
Licensing other payments | 25,000 |
Maximum [Member] | |
Subsequent Event (Details) [Line Items] | |
Licensing other payments | $ 100,000 |