0001213900-22-071222 | 10-Q | XBRL Viewer | Oramed Pharmaceuticals INC

Asset Acquisition Transaction (Details) - USD ($) $ in Thousands	1 Months Ended	9 Months Ended
	Mar. 18, 2021	Sep. 30, 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

Interim Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares	Sep. 30, 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	39,113,236	38,158,792
Common stock, shares outstanding	39,113,236	38,158,792

Marketable Securities (Details) - USD ($) $ in Thousands	Sep. 30, 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

Accounting Policies, by Policy (Policies)

9 Months Ended

Sep. 30, 2022

Accounting Policies [Abstract]

General

General:

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 September 30, 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.

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.

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 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 worsens and continues for an extended period of time and it is continuing to assess the effect on its operations by monitoring the status of COVID-19.

Condensed consolidated financial statements preparation

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.

Loss per common share

Loss per common share

Basic and diluted net loss per share of common stock are computed by dividing the net loss attributable to stockholders for the period by the weighted average number of shares of common stock outstanding for each period, including vested restricted stock units (“RSUs”). Outstanding stock options, warrants and unvested RSUs have been excluded from the calculation of the diluted loss per share because all such securities are anti-dilutive for all periods presented. The weighted average number of common stock options, warrants and RSUs excluded from the calculation of diluted net loss was 3,557,200 and 4,736,797 for the nine month periods ended September 30, 2022 and September 30, 2021, respectively, and 3,715,540 and 3,644,428 for the three month periods ended September 30, 2022 and September 30, 2021, respectively.

Revenue recognition

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 September 30, 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 September 30, 2022, the Company has recognized revenue associated with this agreement in the aggregate amount of $18,361, of which $682 was recognized in the quarter ended September 30, 2022, and deferred the remaining amount of $4,022, which is presented as deferred revenues on the condensed consolidated balance sheet.

On September 1, 2022, the Company entered into a non-binding memorandum of agreement (“MOA”) with Medicox Co., Ltd. (“Medicox”) setting out basic commercial understandings between the parties that would form the basis of a definitive distribution license agreement that would grant Medicox the exclusive right and license to apply for regulatory approval for and distribute the Company’s proprietary ORMD-0801 product, currently in development, in the Republic of Korea for a period of ten years, subject to complying with agreed distribution targets. The definitive agreement would include a transfer price per capsule, as well as milestone and royalty payments upon achievement of certain targets and events. The MOA includes an undertaking by the Company that it will not engage in negotiations with or enter into any agreement with a third party for the grant of distribution and license rights to the Company’s proprietary ORMD-0801 product in the Republic of Korea until December 15, 2022. In consideration for this undertaking, Medicox has made a non-refundable payment of $2,000 to the Company, which was deferred as a contract liability (deferred revenue) as of September 30, 2022 until the potential execution of a definitive agreement. Aside from the foregoing undertaking and confidentiality obligations, the MOA is otherwise a non-binding document prepared for discussion purposes only and the execution of a definitive agreement is conditioned upon the mutual acceptance by the parties.

Recently issued accounting pronouncements, not yet adopted

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.

Interim Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (29,028)	$ (17,508)
Adjustments required to reconcile net loss to net cash used in operating activities:
Depreciation	41	69
Non-cash expense for acquired in-process research and development		1,040
Exchange differences and interest on deposits and held to maturity bonds	(933)	429
Changes in fair value of investments	494	(732)
Stock-based compensation	8,961	2,896
Changes in operating assets and liabilities:
Prepaid expenses and other current assets	1,034	128
Accounts payable, accrued expenses and related parties	(330)	1,875
Net changes in operating lease	(105)
Deferred revenues	(21)	(2,022)
Liability for employee rights upon retirement	(1)
Other liabilities	32	(74)
Total net cash used in operating activities	(19,856)	(13,899)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of held to maturity securities		(8,593)
Purchase of short-term deposits	(111,500)	(6,000)
Investment in long-term deposits		(25,000)
Proceeds from sale of short-term deposits	128,000	9,500
Proceeds from maturity of held to maturity securities	5,336	6,065
Long-term investments	(2,700)
Proceeds from sale of mutual funds		3,029
Funds in respect of employee rights upon retirement	3
Purchase of property and equipment	(188)	(55)
Total net cash provided by (used in) investing activities	18,951	(21,054)
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock, net of issuance costs	7,345	74,743
Proceeds from exercise of warrants and options	42	21,496
Transaction with non-controlling interests		1,500
Tax withholdings related to stock-based compensation settlements	(783)
Total net cash provided by financing activities	6,604	97,739
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS	41	(3)
INCREASE IN CASH AND CASH EQUIVALENTS	5,740	62,783
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD	27,456	21,630
CASH AND CASH EQUIVALENTS AT END OF PERIOD	33,196	84,413
(A) SUPPLEMENTARY DISCLOSURE ON CASH FLOWS -
Interest received	906	505
(B) SUPPLEMENTARY DISCLOSURE ON CASH FLOWS -
Recognition of operating lease right of use assets and liabilities	678
(C) ASSET ACQUISITION TRANSACTION (see note 8) -
In-process research and development		1,040
Transaction with non-controlling interests		1,500
Additional paid in capital		(1,045)
Non-controlling interests		$ (1,495)

Asset Acquisition Transaction

9 Months Ended

Sep. 30, 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.

Leases (Details) - Schedule of lease payments for the company’s right-of-use assets over the remaining lease periods - USD ($)
$ in Thousands

Sep. 30, 2022

Dec. 31, 2021

Schedule Of Lease Payments For The Company SRight Of Use Assets Over The Remaining Lease Periods Abstract

2022

$ 68

$ 155

2023

270

140

2024

270

140

2025

210

2026

123

2027

Total undiscounted lease payments

951

528

Less: Interest

^[1]

(51)

(28)

Present value of lease liabilities

$ 900

$ 500

[1]	Future lease payments were discounted by 3% interest rate.

Leases (Details)	9 Months Ended
Leases (Details)	Sep. 30, 2022
Leases [Abstract]
Future lease payments, interest rate percentage	3.00%

Commitments (Details) $ in Thousands							1 Months Ended							9 Months Ended
Commitments (Details) $ in Thousands	Apr. 27, 2022 USD ($)	Sep. 16, 2020 USD ($)	Sep. 02, 2020 USD ($)	Dec. 18, 2017 USD ($)	Dec. 28, 2015 USD ($)	Nov. 30, 2015	Aug. 26, 2022 USD ($)	Jan. 31, 2019 USD ($)	Oct. 31, 2016 USD ($)	Jul. 31, 2016 USD ($)	Jan. 31, 2016 USD ($)	Jul. 31, 2015 USD ($)	Mar. 31, 2011 shares	Sep. 30, 2022 USD ($)	Sep. 30, 2022 ILS (₪)	Feb. 15, 2011
Commitments (Details) [Line Items]
License agreement, description														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%.
Aggregate amount														$ 20,500
Initial payment											$ 3,000
Payment obligation disputed														6,000
Deferred revenue														2,000
Stock purchase agreement with HTIT description						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.
Total consideration														49,500
Issuance of common stock														10,617
Issuance expense														23
License agreement					$ 38,883
Non refundable amount												$ 500
Annual lease payment														123	₪ 435
Total amount received														2,208
Liability														133
Fees amount	$ 850
Issued and outstanding, percentage							5.00%
Vendor One [Member]
Commitments (Details) [Line Items]
Capsule ingredients amount				$ 2,905
Research and development expenses				$ 1,592
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
Vendor Two [Member]
Commitments (Details) [Line Items]
Research and development expenses														15,280
Commitments for considering service			$ 22,684
Vendor Three [Member]
Commitments (Details) [Line Items]
Research and development expenses														$ 7,357
Commitments for considering service		$ 15,796
Israel Innovation Authority [Member]
Commitments (Details) [Line Items]
Royalty percentage														3.00%	3.00%
Israel Innovation Authority [Member] \| Minimum [Member]
Commitments (Details) [Line Items]
Royalty percentage														100.00%	100.00%
Israel Innovation Authority [Member] \| Maximum [Member]
Commitments (Details) [Line Items]
Royalty percentage														(150.00%)	(150.00%)
Royalty [Member]
Commitments (Details) [Line Items]
Royalty term														15 years
Series B Preferred Stock [Member]
Commitments (Details) [Line Items]
Aggregate purchase price							$ 2,700
London Interbank Offered Rate (LIBOR) [Member]
Commitments (Details) [Line Items]
Total amount received														$ 2,530
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%

Stockholders’ Equity

9 Months Ended

Sep. 30, 2022

Stockholders' Equity Note [Abstract]

STOCKHOLDERS’ EQUITY

NOTE 5 - STOCKHOLDERS’ EQUITY:

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 September 30, 2022 and November 10, 2022, 1,334,695 shares were issued under the Cantor Equity Distribution Agreement for aggregate net proceeds of $19,664.

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.

The following are the significant stock options transactions with employees and board members made during the nine months ended September 30, 2022:

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.

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).

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.

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.

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. 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.

On July 28, 2022, the Company granted an aggregate of 404,100 RSUs representing a right to receive shares of the Company’s common stock to the Company’s executive officers, employees and board members. The RSUs granted to certain employees, executive officers and board members will vest in three equal annual instalments on each of January 1, 2024, 2025 and 2026 and the RSUs granted to certain employees will vest in three equal annual instalments on each of January 1, 2023, 2024 and 2025. The total fair value of these RSUs on the date of grant was $3,423, using the quoted closing market share price of $8.47 on the Nasdaq Capital Market on the date of grant.

On July 28, 2022, the Company granted 34,000 shares of the Company’s common stock to each of the Company’s President and Chief Executive Officer and Chief Scientific Officer. These shares vested in full on August 1, 2022. The total fair value of these shares on the date of grant was $576, using the quoted closing market share price of $8.47 on the Nasdaq Capital Market on the date of grant.

On July 28, 2022, the Company granted an aggregate of 175,500 performance based RSUs (“PSUs”) representing a right to receive shares of the Company’s common stock to the Company’s executive officers. The PSUs will vest in two instalments upon achievement of the following milestones: (i) two thirds shall vest upon receipt of positive topline data in the first oral insulin Phase 3 clinical trial (675 patients in the U.S. under protocol ORA-D-013-1); and (ii) one third shall vest upon completion of enrollment of the second oral insulin Phase 3 clinical trial (450 patients in the U.S., E.U. and Israel under protocol ORA-D-013-2) by June 30, 2023. The total fair value of these PSUs on the date of grant was $1,486, using the quoted closing market share price of $8.47 on the Nasdaq Capital Market on the date of grant.

On September 18, 2022, Oravax granted options to purchase an aggregate of 328,318 shares of Oravax’s common stock to employees and board members of Oravax and to other service providers at an exercise price of $3.91 per share. The options will vest in four annual instalments as follows: the first instalment vested immediately on the grant date and the remaining three instalments will vest on each of December 31, 2022, 2023 and 2024. These options expire on September 18, 2032. The fair value of these options on the date of grant was $665, using the Black Scholes option pricing model and was based on the following assumptions: stock price of $3.91; dividend yield of 0% for all years; expected volatility of 52.87%; risk-free interest rates of 3.62%; and expected term of 5.49 years.

- Definition

The entire disclosure for shareholders' equity comprised of portions attributable to the parent entity and noncontrolling interest, including other comprehensive income. Includes, but is not limited to, balances of common stock, preferred stock, additional paid-in capital, other capital and retained earnings, accumulated balance for each classification of other comprehensive income and amount of comprehensive income.

+ References

Reference 1: http://fasb.org/us-gaap/role/ref/legacyRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-URI https://asc.fasb.org/topic&trid=2208762

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Publisher FASB
-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 13
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Topic 505
-SubTopic 10
-Section 50
-Paragraph 14
-Subparagraph (c)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496171-112644

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-SubTopic 10
-Section 50
-Paragraph 14
-Subparagraph (b)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496171-112644

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-SubTopic 10
-Section S99
-Paragraph 1
-Subparagraph (SX 210.3-04)
-URI https://asc.fasb.org/extlink&oid=120397183&loc=d3e187085-122770

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
-Topic 505
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-Paragraph 18
-Subparagraph (d)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496189-112644

Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-Subparagraph (g)
-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496189-112644

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496158-112644

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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Reference 12: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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-Name Accounting Standards Codification
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-URI https://asc.fasb.org/extlink&oid=126973232&loc=SL123496180-112644

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
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Reference 15: http://www.xbrl.org/2003/role/disclosureRef
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Reference 16: http://www.xbrl.org/2003/role/disclosureRef
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-Subparagraph (a)
-URI https://asc.fasb.org/extlink&oid=126731327&loc=SL126733271-114008

+ Details

Stockholders’ Equity (Details) - USD ($) $ / shares in Units, $ in Thousands					1 Months Ended		9 Months Ended
	May 02, 2022	Jan. 03, 2022	Nov. 03, 2021	Sep. 01, 2021	Sep. 18, 2022	Jul. 28, 2022	Sep. 30, 2022	Nov. 10, 2022
Stockholders’ Equity (Details) [Line Items]
Securities purchase agreement			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	7,500	30,000			328,318
Total fair value (in Dollars)		$ 2,084
Share price (in Dollars per share)	$ 5.14	$ 13.89				$ 8.47
Granted shares	4,500
Exercise price (in Dollars per share)	$ 5.14	$ 12.03			$ 3.91
Expired date	May 02, 2032	Jan. 03, 2032
Grant amount (in Dollars)	$ 24	$ 214			$ 665	$ 576
Stock price (in Dollars per share)	$ 5.14	$ 12.03			$ 3.91
Dividend yield	0.00%	0.00%			0.00%
Expected volatility	65.26%	63.22%			52.87%
Risk-free interest rates	3.03%	1.60%			3.62%
Expected term	6 years 3 months 3 days	6 years 3 months			5 years 5 months 26 days
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.
Board of Directors Chairman [Member]
Stockholders’ Equity (Details) [Line Items]
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				$ 8.47
Grant amount (in Dollars)	$ 23					$ 3,423
Employees and Board members [Member]
Stockholders’ Equity (Details) [Line Items]
Aggregate of shares of common stock		150,000
Sale Agreement [Member]
Stockholders’ Equity (Details) [Line Items]
Aggregate offering price (in Dollars)				$ 100,000
Agent commission rate							3.00%
Shares, issued							1,334,695
Aggregate net proceeds (in Dollars)							$ 19,664
Sale Agreement [Member] \| Subsequent Event [Member]
Stockholders’ Equity (Details) [Line Items]
Shares, issued								1,334,695
Chief Executive Officer [Member]
Stockholders’ Equity (Details) [Line Items]
Aggregate of shares of common stock						34,000
Common stock issued to employees		63,000
President [Member]
Stockholders’ Equity (Details) [Line Items]
Aggregate of shares of common stock						34,000
Common stock issued to employees		63,000
Chief Scientific Officer [Member]
Stockholders’ Equity (Details) [Line Items]
Aggregate of shares of common stock						34,000
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
Granted shares		12.03
Board of Directors Chairman [Member]
Stockholders’ Equity (Details) [Line Items]
Aggregate of shares of common stock		24,000
Executive Officer [Member]
Stockholders’ Equity (Details) [Line Items]
Aggregate of shares of common stock						404,100
Employees and Board members [Member]
Stockholders’ Equity (Details) [Line Items]
Aggregate of shares of common stock						404,100
Nasdaq Capital Market [Member] \| Restricted Stock Units (RSUs) [Member]
Stockholders’ Equity (Details) [Line Items]
Aggregate of shares of common stock						175,500
Share price (in Dollars per share)						$ 8.47
Grant amount (in Dollars)						$ 1,486

Leases (Details) - Schedule of operating right-of-use assets and operating lease liabilities - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Schedule Of Operating Right Of Use Assets And Operating Lease Liabilities Abstract
Operating right-of-use assets	$ 1,005	$ 500
Operating lease liabilities, current	228	130
Operating lease liabilities long-term	672	370
Total operating lease liabilities	$ 900	$ 500

Marketable Securities (Details) - Schedule of amortized cost and estimated fair value of held to maturity securities - USD ($) $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2022	Dec. 31, 2021
Short-term:
Amortized cost	$ 4,528	$ 10,422
Gross unrealized gains (losses)	(129)	(144)
Estimated fair value	4,399	10,278
Commercial bonds [Member]
Short-term:
Amortized cost	4,485	6,432
Gross unrealized gains (losses)	(129)	(115)
Estimated fair value	$ 4,356	$ 6,317
Average yield to maturity rate	1.05%	1.37%
Accrued interest [Member]
Short-term:
Amortized cost	$ 43	$ 115
Gross unrealized gains (losses)
Estimated fair value	$ 43	115
Long-term [Member]
Short-term:
Amortized cost		3,875
Gross unrealized gains (losses)		(29)
Estimated fair value		$ 3,846
Average yield to maturity rate		1.20%

Significant Accounting Policies (Details) - USD ($)	1 Months Ended	3 Months Ended		9 Months Ended
Significant Accounting Policies (Details) - USD ($)	Dec. 28, 2015	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021	Mar. 18, 2021
Significant Accounting Policies (Details) [Line Items]
Weighted average number of common stock (in Shares)		3,715,540	3,644,428	3,557,200	4,736,797
Recognized revenue aggregate amount				$ 18,361,000
Deferred revenue recognized				682,000
Deferred revenue recognized remaining amount				4,022,000
Non-refundable payment				2,000
HTIT License Agreement [Member]
Significant Accounting Policies (Details) [Line Items]
Total consideration	$ 49,500,000
Value of common stock issued	38,883,000			$ 22,382,000
Stock Purchase Agreement [Member]
Significant Accounting Policies (Details) [Line Items]
Value of common stock issued	10,617,000
issuance expenses	$ 23,000
Stockholders Agreement [Member]
Significant Accounting Policies (Details) [Line Items]
Shares issued (in Shares)						1,890,000
Capital stock percentage						63.00%

Interim Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
CURRENT ASSETS:
Cash and cash equivalents	$ 33,196	$ 27,456
Short-term deposits	121,119	111,077
Marketable securities	5,234	7,747
Prepaid expenses and other current assets	623	1,657
Total current assets	160,172	147,937
LONG-TERM ASSETS:
Long-term deposits	2	25,094
Long-term investments	2,700
Marketable securities		3,875
Amounts funded in respect of employee rights upon retirement	23	26
Property and equipment, net	535	388
Operating lease right-of-use assets	1,005	500
Total long-term assets	4,265	29,883
Total assets	164,437	177,820
CURRENT LIABILITIES:
Accounts payable, accrued expenses and other liabilities	4,205	4,535
Deferred revenues	2,022	2,703
Payable to related parties	70
Operating lease liabilities	228	130
Total current liabilities	6,525	7,368
LONG-TERM LIABILITIES:
Long-term deferred revenues	4,000	3,340
Employee rights upon retirement	21	22
Provision for uncertain tax position	11	11
Operating lease liabilities	672	370
Other liabilities	61	99
Total long-term liabilities	4,765	3,842
COMMITMENTS (note 2)
EQUITY ATTRIBUTABLE TO COMPANY’S STOCKHOLDERS:
Common stock, $0.012 par value (60,000,000 authorized shares; 39,113,236 and 38,158,792 shares issued and outstanding as of September 30, 2022 and December 31, 2021, respectively)	470	459
Additional paid-in capital	307,876	292,514
Accumulated deficit	(154,538)	(126,520)
Total stockholders’ equity	153,808	166,453
Non-controlling interests	(661)	157
Total equity	153,147	166,610
Total liabilities and equity	$ 164,437	$ 177,820

Related Party Transactions

9 Months Ended

Sep. 30, 2022

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 ($41) and NIS 106,400 ($30), 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 nine months ended September 30, 2022, such relocation expenses were $201, compared to $198 for the nine months ended September 30, 2021.

Marketable Securities (Details) - Schedule of marketable securities include investments in equity securities of DNA and Entera and in held to maturity bonds - USD ($) $ in Thousands	Sep. 30, 2022	Dec. 31, 2021
Marketable Securities [Line Items]
Short-term	$ 5,234	$ 7,747
Long-term	5,234	11,622
Held to maturity securities [Member]
Marketable Securities [Line Items]
Long-term		3,875
DNA [Member]
Marketable Securities [Line Items]
Short-term	584	863
Entera [Member]
Marketable Securities [Line Items]
Short-term	122	337
Held to maturity securities [Member]
Marketable Securities [Line Items]
Short-term	$ 4,528	$ 6,547

- Definition

Amount, excluding unamortized premium (discount) and debt issuance cost, of long-term debt. Excludes lease obligation.

+ References + Details

Related Party Transactions (Details) ₪ in Thousands, $ in Thousands	1 Months Ended		9 Months Ended
	Jul. 01, 2008 USD ($)	Jul. 01, 2008 ILS (₪)	Sep. 30, 2022 USD ($)	Sep. 30, 2021 USD ($)
Related Party Transactions (Details) [Line Items]
Relocation expenses			$ 201	$ 198
Chief Executive Officer [Member]
Related Party Transactions (Details) [Line Items]
Consulting agreements fee	$ (41)	₪ 146,705
Chief Scientific Officer [Member]
Related Party Transactions (Details) [Line Items]
Consulting agreements fee	$ (30)	₪ 106,400

Document And Entity Information - shares	9 Months Ended
Document And Entity Information - shares	Sep. 30, 2022	Nov. 10, 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		39,114,736
Amendment Flag	false
Entity Central Index Key	0001176309
Entity Current Reporting Status	Yes
Entity Filer Category	Non-accelerated Filer
Document Period End Date	Sep. 30, 2022
Document Fiscal Year Focus	2022
Document Fiscal Period Focus	Q3
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Document Quarterly Report	true
Document Transition Report	false
Entity File Number	001-35813
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	98-0376008
Entity Address, Address Line One	1185 Avenue of the Americas
Entity Address, Address Line Two	Third Floor
Entity Address, City or Town	New York
Entity Address, State or Province	NY
Entity Address, Postal Zip Code	10036
City Area Code	844
Local Phone Number	967-2633
Title of 12(b) Security	Common Stock, par value $0.012
Security Exchange Name	NASDAQ
Entity Interactive Data Current	Yes

Interim Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Income Statement [Abstract]
REVENUES	$ 682	$ 682	$ 2,022	$ 2,022
RESEARCH AND DEVELOPMENT EXPENSES	5,347	6,086	20,362	15,452
SALES AND MARKETING EXPENSES	463	172	1,433	172
GENERAL AND ADMINISTRATIVE EXPENSES	3,061	1,909	11,085	4,937
OPERATING LOSS	8,189	7,485	30,858	18,539
FINANCIAL INCOME (EXPENSE), NET	1,036	(51)	1,930	1,031
LOSS BEFORE TAX EXPENSES	7,153	7,536	28,928	17,508
TAX EXPENSES	100		100
NET LOSS FOR THE PERIOD	7,253	7,536	29,028	17,508
NET LOSS ATTRIBUTABLE TO NON-CONTROLLING INTERESTS	193	279	1,010	764
NET LOSS ATTRIBUTABLE TO STOCKHOLDERS	$ 7,060	$ 7,257	$ 28,018	$ 16,744
LOSS PER SHARE
BASIC LOSS PER SHARE OF COMMON STOCK (in Dollars per share)	$ 0.18	$ 0.21	$ 0.72	$ 0.54
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING BASIC AND DILUTED LOSS PER SHARE OF COMMON STOCK (in Shares)	39,100,231	34,539,487	38,856,514	31,097,270

Fair Value

9 Months Ended

Sep. 30, 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 September 30, 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 September 30, 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.

The amounts funded in respect of employee rights are stated at cash surrender value which approximates its fair value.

- Definition

The entire disclosure for the fair value of financial instruments (as defined), including financial assets and financial liabilities (collectively, as defined), and the measurements of those instruments as well as disclosures related to the fair value of non-financial assets and liabilities. Such disclosures about the financial instruments, assets, and liabilities would include: (1) the fair value of the required items together with their carrying amounts (as appropriate); (2) for items for which it is not practicable to estimate fair value, disclosure would include: (a) information pertinent to estimating fair value (including, carrying amount, effective interest rate, and maturity, and (b) the reasons why it is not practicable to estimate fair value; (3) significant concentrations of credit risk including: (a) information about the activity, region, or economic characteristics identifying a concentration, (b) the maximum amount of loss the entity is exposed to based on the gross fair value of the related item, (c) policy for requiring collateral or other security and information as to accessing such collateral or security, and (d) the nature and brief description of such collateral or security; (4) quantitative information about market risks and how such risks are managed; (5) for items measured on both a recurring and nonrecurring basis information regarding the inputs used to develop the fair value measurement; and (6) for items presented in the financial statement for which fair value measurement is elected: (a) information necessary to understand the reasons for the election, (b) discussion of the effect of fair value changes on earnings, (c) a description of [similar groups] items for which the election is made and the relation thereof to the balance sheet, the aggregate carrying value of items included in the balance sheet that are not eligible for the election; (7) all other required (as defined) and desired information.

+ References + Details

Commitments

9 Months Ended

Sep. 30, 2022

Commitments and Contingencies Disclosure [Abstract]

COMMITMENTS

NOTE 2 - COMMITMENTS:

In March 2011, the Subsidiary sold shares of its investee company, Entera Bio Ltd. (“Entera”) to DNA GROUP (T.R.) Ltd. (formerly D.N.A Biomedical Solutions Ltd.) (“DNA”), retaining 117,000 ordinary shares (after giving effect to a stock split by Entera in July 2018). In consideration for the shares sold to DNA, the Company received, among other payments, ordinary shares of DNA (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 September 30, 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.

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 September 30, 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 September 30, 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.

For the Company’s revenue recognition policy see note 1d.

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 September 30, 2022.

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. The CRO Services Agreement was amended effective May 26, 2022 and as consideration for its services, the Subsidiary will pay the CRO a total amended amount of $22,684 during the term of the engagement and based on achievement of certain milestones, of which $15,280 was recognized in research and development expenses through September 30, 2022.

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. The CRO Services Agreement was amended effective May 26, 2022 and as consideration for its services, the Subsidiary will pay the CRO a total amended amount of $15,796 during the term of the engagement and based on achievement of certain milestones, of which $7,357 was recognized in research and development expenses through September 30, 2022.

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 $123). 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.

Grants from the Israel Innovation Authority (“IIA”)

Under the terms of the Company’s funding from the IIA, royalties of 3% are payable on sales of products developed from a project so funded, up to a maximum amount equaling 100%-150% of the grants received (dollar linked) with the addition of interest at an annual rate based on LIBOR.

At the time the grants were received, successful development of the related projects was not assured. The total amount received through September 30, 2022 was $2,208 ($2,530 including interest).

As of September 30, 2022, the liability to the IIA was $133.

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 in attorneys’ fees, which was paid on April 28, 2022 and included in general and administrative expenses in the first quarter of 2022. All other details of the settlement were previously agreed by the parties and acted upon at the Company’s 2021 annual meeting of stockholders.

Investment in Diasome Pharmaceuticals, Inc.

On August 26, 2022, the Company entered into a stock purchase agreement with Diasome Pharmaceuticals, Inc. (“Diasome”) pursuant to which the Company purchased shares of Series B preferred stock of Diasome for an aggregate purchase price of approximately $2,700. Following the purchase, the Company holds less than 5% of the issued and outstanding stock of Diasome on a diluted basis. The stock purchase agreement provides the Company with the option to purchase additional preferred shares of stock on a pro rata basis at similar terms to the terms and conditions of the current round contingent upon Diasome achieving certain milestones.

The Company will account for the investment under the measurement alternative in ASC 321, whereby the equity investment is recorded at cost, less impairment. The carrying amount will be subsequently remeasured to its fair value in accordance with the provisions of ASC 820 when observable price changes occur as of the date the transaction occurred, or it is impaired. Any adjustments to the carrying amount are recorded in net income.

Diasome is the developer of Hepatocyte Directed Vesicles (HDV™), a liver targeting system in development for drugs used to treat diabetes. When combined with insulin, HDV™ enables preferential insulin delivery to liver hepatocytes in order to reduce the risk of hypoglycemia in patients.

Leases (Tables)

9 Months Ended

Sep. 30, 2022

Leases [Abstract]

Schedule of operating right-of-use assets and operating lease liabilities

	September 30, 2022		December 31, 2021
Operating right-of-use assets	$	1,005	$	500

Operating lease liabilities, current		228		130
Operating lease liabilities long-term		672		370
Total operating lease liabilities	$	900	$	500

Schedule of lease payments for the company’s right-of-use assets over the remaining lease periods

	September 30, 2022			December 31, 2021
2022	$	68		$	155
2023		270			140
2024		270			140
2025		210			93
2026		123			-
2027		10			-
Total undiscounted lease payments		951			528
Less: Interest*		(51	)		(28	)
Present value of lease liabilities	$	900		$	500

Future lease payments were discounted by 3% interest rate.

Leases

9 Months Ended

Sep. 30, 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 September 30, 2022 and December 31, 2021:

	September 30, 2022		December 31, 2021
Operating right-of-use assets	$	1,005	$	500

Operating lease liabilities, current		228		130
Operating lease liabilities long-term		672		370
Total operating lease liabilities	$	900	$	500

Lease payments for the Company’s right-of-use assets over the remaining lease periods as of September 30, 2022 and December 31, 2021 are as follows:

	September 30, 2022			December 31, 2021
2022	$	68		$	155
2023		270			140
2024		270			140
2025		210			93
2026		123			-
2027		10			-
Total undiscounted lease payments		951			528
Less: Interest*		(51	)		(28	)
Present value of lease liabilities	$	900		$	500

Future lease payments were discounted by 3% interest rate.

Significant Accounting Policies

9 Months Ended

Sep. 30, 2022

Accounting Policies [Abstract]

SIGNIFICANT ACCOUNTING POLICIES

NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES:

General:

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 May 14, 2007, the Company incorporated a wholly-owned subsidiary in Israel, Oramed Ltd. (the “Subsidiary”), which is engaged in research and development.

Change in Fiscal Year

Development and Liquidity Risks

Condensed consolidated financial statements preparation

Loss per common share

Revenue recognition

Recently issued accounting pronouncements, not yet adopted

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

BALANCE (in Shares) at Dec. 31, 2020

26,660

ISSUANCE OF COMMON STOCK, NET

$ 70

74,673

74,743

ISSUANCE OF COMMON STOCK, NET (in Shares)

5,860

EXERCISE OF WARRANTS AND OPTIONS

$ 38

21,458

21,496

EXERCISE OF WARRANTS AND OPTIONS (in Shares)

3,164

STOCK-BASED COMPENSATION

2,896

ASSET ACQUISITION

1,045

1,495

2,540

NET LOSS

(16,744)

(764)

(17,508)

BALANCE at Sep. 30, 2021

$ 428

238,659

(116,682)

122,405

731

123,136

BALANCE (in Shares) at Sep. 30, 2021

35,684

BALANCE at Jun. 30, 2021

$ 390

198,730

(109,425)

89,695

1,010

90,705

BALANCE (in Shares) at Jun. 30, 2021

32,513

ISSUANCE OF COMMON STOCK, NET

$ 19

27,584

27,603

ISSUANCE OF COMMON STOCK, NET (in Shares)

1,573

EXERCISE OF WARRANTS AND OPTIONS

$ 19

11,065

11,084

EXERCISE OF WARRANTS AND OPTIONS (in Shares)

1,598

STOCK-BASED COMPENSATION

1,280

NET LOSS

(7,257)

(279)

(7,536)

BALANCE at Sep. 30, 2021

$ 428

238,659

(116,682)

122,405

731

123,136

BALANCE (in Shares) at Sep. 30, 2021

35,684

BALANCE at Dec. 31, 2021

$ 459

292,514

(126,520)

166,453

157

166,610

BALANCE (in Shares) at Dec. 31, 2021

38,158

ISSUANCE OF COMMON STOCK, NET

$ 9

7,336

7,345

ISSUANCE OF COMMON STOCK, NET (in Shares)

770

EXERCISE OF WARRANTS AND OPTIONS

^[1]

EXERCISE OF WARRANTS AND OPTIONS (in Shares)

STOCK-BASED COMPENSATION

$ 2

8,767

8,769

STOCK-BASED COMPENSATION (in Shares)

151

STOCK-BASED COMPENSATION OF SUBSIDIARY

192

TAX WITHHOLDINGS RELATED TO STOCK-BASED COMPENSATION SETTLEMENTS

(783)

NET LOSS

(28,018)

(1,010)

(29,028)

BALANCE at Sep. 30, 2022

$ 470

307,876

(154,538)

153,808

(661)

153,147

BALANCE (in Shares) at Sep. 30, 2022

39,113

BALANCE at Jun. 30, 2022

$ 463

300,712

(147,478)

153,697

(660)

153,037

BALANCE (in Shares) at Jun. 30, 2022

38,564

ISSUANCE OF COMMON STOCK, NET

$ 6

4,371

4,377

ISSUANCE OF COMMON STOCK, NET (in Shares)

493

EXERCISE OF WARRANTS AND OPTIONS

^[1]

EXERCISE OF WARRANTS AND OPTIONS (in Shares)

STOCK-BASED COMPENSATION

$ 1

2,857

2,858

STOCK-BASED COMPENSATION (in Shares)

STOCK-BASED COMPENSATION OF SUBSIDIARY

192

TAX WITHHOLDINGS RELATED TO STOCK-BASED COMPENSATION SETTLEMENTS

(106)

NET LOSS

(7,060)

(193)

(7,253)

BALANCE at Sep. 30, 2022

$ 470

$ 307,876

$ (154,538)

$ 153,808

$ (661)

$ 153,147

BALANCE (in Shares) at Sep. 30, 2022

39,113

[1]	Less than $1

Marketable Securities

9 Months Ended

Sep. 30, 2022

Investments, Debt and Equity Securities [Abstract]

MARKETABLE SECURITIES

NOTE 4 - MARKETABLE SECURITIES:

The Company’s marketable securities include investments in equity securities of DNA and Entera and in held to maturity securities.

Composition:

	September 30, 2022		December 31, 2021
Short-term:
DNA (see b below)	$	584	$	863
Entera (see c below)		122		337
Held to maturity securities (see d below)		4,528		6,547
	$	5,234	$	7,747
Long-term:
Held to maturity securities (see d below)	$	-	$	3,875
	$	5,234	$	11,622

DNA

The DNA ordinary shares are traded on the Tel Aviv Stock Exchange. The fair value of those securities is measured at the quoted prices of the securities on the measurement date.

As of September 30, 2022, the Company owns approximately 1.4% of DNA’s outstanding ordinary shares.

The cost of the securities as of both September 30, 2022 and December 31, 2021 was $595.

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)).

Held to maturity securities

The amortized cost and estimated fair value of held to maturity securities as of September 30, 2022, were as follows:

	September 30, 2022
	Amortized cost		Gross unrealized gains (losses)			Estimated fair value		Average yield to maturity rate
Short-term:
Commercial bonds	$	4,485	$	(129	)	$	4,356		1.05	%
Accrued interest		43		-			43
	$	4,528	$	(129	)	$	4,399

The amortized cost and estimated fair value of held to maturity securities as of December 31, 2021, were as follows:

	December 31, 2021
	Amortized cost		Gross unrealized gains (losses)			Estimated fair value		Average yield to maturity rate
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.

Marketable Securities (Tables)

9 Months Ended

Sep. 30, 2022

Investments, Debt and Equity Securities [Abstract]

Schedule of marketable securities include investments in equity securities of DNA and Entera and in held to maturity bonds

	September 30, 2022		December 31, 2021
Short-term:
DNA (see b below)	$	584	$	863
Entera (see c below)		122		337
Held to maturity securities (see d below)		4,528		6,547
	$	5,234	$	7,747
Long-term:
Held to maturity securities (see d below)	$	-	$	3,875
	$	5,234	$	11,622

Schedule of amortized cost and estimated fair value of held to maturity securities

	September 30, 2022
	Amortized cost		Gross unrealized gains (losses)			Estimated fair value		Average yield to maturity rate
Short-term:
Commercial bonds	$	4,485	$	(129	)	$	4,356		1.05	%
Accrued interest		43		-			43
	$	4,528	$	(129	)	$	4,399

	December 31, 2021
	Amortized cost		Gross unrealized gains (losses)			Estimated fair value		Average yield to maturity rate
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

Interim Condensed Consolidated Statements of Comprehensive Loss (Unaudited) (Parentheticals) - $ / shares	3 Months Ended		9 Months Ended
	Sep. 30, 2022	Sep. 30, 2021	Sep. 30, 2022	Sep. 30, 2021
Income Statement [Abstract]
DILUTED LOSS PER SHARE OF COMMON STOCK	$ 0.18	$ 0.21	$ 0.72	$ 0.54
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING BASIC LOSS PER SHARE OF COMMON STOCK (in Shares)	39,100,231	34,539,487	38,856,514	31,097,270

- Definition

The amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period.

+ References

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+ Details