Oramed Pharmaceuticals (ORMP) 10-Q 11 May 23 2023 Q1 Quarterly report Financial data

Document And Entity Information

Document And Entity Information - shares	3 Months Ended
	Mar. 31, 2023	May 11, 2023
Document Information Line Items
Entity Registrant Name	ORAMED PHARMACEUTICALS INC.
Trading Symbol	ORMP
Document Type	10-Q
Current Fiscal Year End Date	--12-31
Entity Common Stock, Shares Outstanding		40,027,396
Amendment Flag	false
Entity Central Index Key	0001176309
Entity Current Reporting Status	Yes
Entity Filer Category	Non-accelerated Filer
Document Period End Date	Mar. 31, 2023
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q1
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Document Quarterly Report	true
Document Transition Report	false
Entity File Number	001-35813
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	98-0376008
Entity Address, Address Line One	1185 Avenue of the Americas
Entity Address, Address Line Two	Third Floor
Entity Address, City or Town	New York
Entity Address, State or Province	NY
Entity Address, Postal Zip Code	10036
City Area Code	844
Local Phone Number	967-2633
Title of 12(b) Security	Common Stock, par value $0.012
Security Exchange Name	NASDAQ
Entity Interactive Data Current	Yes

Interim Condensed Consolidated

Interim Condensed Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
CURRENT ASSETS:
Cash and cash equivalents	$ 24,104	$ 40,464
Short-term deposits	127,363	111,513
Marketable securities	2,267	3,743
Prepaid expenses and other current assets	1,423	1,389
Total current assets	155,157	157,109
LONG-TERM ASSETS:
Long-term deposits	7	7
Long-term investments	2,700	2,700
Amounts funded in respect of employee rights upon retirement	24	24
Property and equipment, net	977	815
Operating lease right-of-use assets	915	987
Total long-term assets	4,623	4,533
Total assets	159,780	161,642
CURRENT LIABILITIES:
Accounts payable and accrued expenses	4,055	4,158
Deferred revenues	674	1,340
Payable to related parties	1	1
Operating lease liabilities	242	247
Total current liabilities	4,972	5,746
LONG-TERM LIABILITIES:
Long-term deferred revenues	4,000	4,000
Employee rights upon retirement	26	21
Provision for uncertain tax position	11	11
Operating lease liabilities	564	647
Other liabilities	59	61
Total long-term liabilities	4,660	4,740
COMMITMENTS (note 3)
EQUITY ATTRIBUTABLE TO COMPANY’S STOCKHOLDERS:
Common stock, $0.012 par value (60,000,000 authorized shares; 39,969,979 and 39,563,888 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively)	481	476
Additional paid-in capital	316,965	314,417
Accumulated deficit	(166,476)	(163,081)
Total stockholders’ equity	150,970	151,812
Non-controlling interests	(822)	(656)
Total equity	150,148	151,156
Total liabilities and equity	$ 159,780	$ 161,642

Interim Condensed Consolidate_2

Interim Condensed Consolidated Balance Sheets (Unaudited) (Parentheticals) - $ / shares	Mar. 31, 2023	Dec. 31, 2022
Statement of Financial Position [Abstract]
Common stock, par value (in Dollars per share)	$ 0.012	$ 0.012
Common stock, shares authorized	60,000,000	60,000,000
Common stock, shares issued	39,969,979	39,563,888
Common stock, shares outstanding	39,969,979	39,563,888

Interim Condensed Consolidate_3

Interim Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Income Statement [Abstract]
REVENUES	$ 666	$ 666
RESEARCH AND DEVELOPMENT EXPENSES	4,427	5,836
SALES AND MARKETING EXPENSES	184	590
GENERAL AND ADMINISTRATIVE EXPENSES	1,263	5,492
OPERATING LOSS	5,208	11,252
FINANCIAL INCOME, NET	1,597	544
NET LOSS	3,611	10,708
NET LOSS ATTRIBUTABLE TO NON-CONTROLLING INTERESTS	216	283
NET LOSS ATTRIBUTABLE TO STOCKHOLDERS	$ 3,395	$ 10,425
BASIC AND DILUTED LOSS PER SHARE OF COMMON STOCK (in Dollars per share)	$ 0.08	$ 0.27
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING BASIC AND DILUTED LOSS PER SHARE OF COMMON STOCK (in Shares)	40,041,258	38,679,622

Interim Condensed Consolidate_4

Interim Condensed Consolidated Statements of Comprehensive Loss (Unaudited) (Parentheticals) - $ / shares	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Income Statement [Abstract]
DILUTED LOSS PER SHARE OF COMMON STOCK	$ 0.07	$ 0.27
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING BASIC LOSS PER SHARE OF COMMON STOCK (in Shares)	40,041,258	38,679,622

Interim Condensed Consolidate_5

Interim Condensed Consolidated Statements of Changes in Stockholders’ Equity (Unaudited) - USD ($) $ in Thousands	Common Stock		Additional paid-in capital	Accumulated deficit	Total stockholders’ equity	Non- controlling interests	Total
BALANCE at Dec. 31, 2021	$ 459		$ 292,514	$ (126,520)	$ 166,453	$ 157	$ 166,610
BALANCE (in Shares) at Dec. 31, 2021	38,158
CHANGES DURING THE THREE MONTH PERIOD ENDED MARCH 31, 2023:
ISSUANCE OF COMMON STOCK, NET	$ 3		2,966		2,969		2,969
ISSUANCE OF COMMON STOCK, NET (in Shares)	277
EXERCISE OF WARRANTS AND OPTIONS		[1]
EXERCISE OF WARRANTS AND OPTIONS (in Shares)	4
STOCK-BASED COMPENSATION	$ 1		4,028		4,029		4,029
STOCK-BASED COMPENSATION (in Shares)	125
TAX WITHHOLDINGS RELATED TO STOCK-BASED COMPENSATION SETTLEMENTS			(677)		(677)		(677)
NET LOSS				(10,425)	(10,425)	(283)	(10,708)
BALANCE at Mar. 31, 2022	$ 463		298,831	(136,945)	162,349	(126)	162,223
BALANCE (in Shares) at Mar. 31, 2022	38,564
BALANCE at Dec. 31, 2022	$ 476		314,417	(163,081)	151,812	(656)	151,156
BALANCE (in Shares) at Dec. 31, 2022	39,564
CHANGES DURING THE THREE MONTH PERIOD ENDED MARCH 31, 2023:
ISSUANCE OF COMMON STOCK, NET	$ 2		2,428		2,430		2,430
ISSUANCE OF COMMON STOCK, NET (in Shares)	193
STOCK-BASED COMPENSATION	$ 3		120		123		123
STOCK-BASED COMPENSATION (in Shares)	213
STOCK-BASED COMPENSATION OF SUBSIDIARY						50	50
NET LOSS				(3,395)	(3,395)	(216)	(3,611)
BALANCE at Mar. 31, 2023	$ 481		$ 316,965	$ (166,476)	$ 150,970	$ (822)	$ 150,148
BALANCE (in Shares) at Mar. 31, 2023	39,970
[1] Represents an amount of less than $1.

Interim Condensed Consolidate_6

Interim Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$ (3,611)	$ (10,708)
Adjustments required to reconcile net loss to net cash used in operating activities:
Depreciation	37	11
Exchange differences and interest on deposits and held to maturity bonds	(1,267)	(235)
Changes in fair value of investments	(65)	(110)
Stock-based compensation	173	4,029
Changes in operating assets and liabilities:
Prepaid expenses and other current assets	(34)	(295)
Accounts payable, accrued expenses and related parties	(103)	(1,151)
Net changes in operating lease	(16)
Deferred revenues	(666)	(666)
Liability for employee rights upon retirement	5
Other liabilities	(2)
Total net cash used in operating activities	(5,549)	(9,125)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of short-term deposits	(19,000)
Proceeds from short-term deposits	4,500	5,000
Proceeds from maturity of held to maturity securities	1,496	2,406
Purchase of property and equipment	(199)	(47)
Total net cash provided by (used in) investing activities	(13,203)	7,359
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock, net of issuance costs	2,430	2,969
Tax withholdings related to stock-based compensation settlements		(677)
Total net cash provided by financing activities	2,430	2,292
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS	(38)	(15)
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS	(16,360)	511
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD	40,464	27,456
CASH AND CASH EQUIVALENTS AT END OF PERIOD	24,104	27,967
(A) SUPPLEMENTARY DISCLOSURE ON CASH FLOWS -
Interest received	308	122
(B) SUPPLEMENTARY DISCLOSURE ON CASH FLOWS -
Recognition of operating lease right-of-use assets and liabilities		$ 647

General

General	3 Months Ended
	Mar. 31, 2023
General [Abstract]
GENERAL	NOTE 1 - GENERAL: a. Incorporation and Operations Oramed Pharmaceuticals Inc. (collectively with its subsidiaries, the “Company”, unless the context indicates otherwise), a Delaware corporation, was incorporated on April 12, 2002. On February 17, 2006, the Company entered into an agreement with Hadasit Medical Services and Development Ltd. to acquire the provisional patent related to an orally ingestible insulin capsule to be used for the treatment of individuals with diabetes. On May 14, 2007, the Company incorporated a wholly-owned subsidiary in Israel, Oramed Ltd. (the “Subsidiary”), which is engaged in research and development. On July 30, 2019, the Subsidiary incorporated a wholly-owned subsidiary in Hong Kong, Oramed HK Limited (the “Hong Kong Subsidiary”). As of March 31, 2023, 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. On January 11, 2023, the Company announced that the ORA-D-013-1 Phase 3 trial did not meet its primary and secondary endpoints. As a result, the Company terminated this trial and a parallel Phase 3, ORA-D-013-2 clinical trial. The Company has also initiated a comprehensive analysis of the data to understand if there is a path forward for its oral insulin candidate. Concurrently, the Company is examining its existing pipeline and has commenced an evaluation process of potential strategic opportunities, with the goal of enhancing value for the Company’s stockholders. As these results are considered a triggering event, the Company evaluated all of its long lived assets which include fixed assets and operating lease right-of-use assets in the first quarter of 2023 and concluded that no impairment is required. b. Development and Liquidity Risks The Company is engaged in research and development in the biotechnology field for innovative pharmaceutical solutions, including an orally ingestible insulin capsule to be used for the treatment of individuals with diabetes, and the use of orally ingestible capsules for delivery of other polypeptides, and has not generated significant revenues from its operations. 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 may also need additional funds to realize the decisions made as part of its strategic review process. The Company cannot predict the outcome of these activities.

Significant Accounting Policies

Significant Accounting Policies	3 Months Ended
	Mar. 31, 2023
Accounting Policies [Abstract]
SIGNIFICANT ACCOUNTING POLICIES	NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES: a. Condensed consolidated financial statements preparation The condensed consolidated financial statements included herein have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) and, on the same basis as the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 (the “2022 Form 10-K”). These condensed consolidated financial statements reflect all adjustments that are of a normal recurring nature and that are considered necessary for a fair statement of the results of the periods presented. Certain information and disclosures normally included in annual consolidated financial statements have been omitted in this interim period report pursuant to the rules and regulations of the Securities and Exchange Commission. Because the condensed consolidated interim financial statements do not include all of the information and disclosures required by U.S. GAAP for annual financial statements, they should be read in conjunction with the audited consolidated financial statements and notes included in the 2022 Form 10-K. The results for interim periods are not necessarily indicative of a full fiscal year’s results. b. Loss per common share Basic and diluted net loss per share of common stock are computed by dividing the net loss attributable to stockholders for the period by the weighted average number of shares of common stock outstanding for each period, including vested restricted stock units (“RSUs”). Outstanding stock options, warrants and unvested RSUs have been excluded from the calculation of the diluted loss per share because all such securities are anti-dilutive for all periods presented. The weighted average number of common stock options, warrants and RSUs excluded from the calculation of diluted net loss was 3,357,911 and 3,463,525 for the three month periods ended March 31, 2023 and March 31, 2022, respectively. c. Revenue recognition HTIT On November 30, 2015, the Company entered into a Technology License Agreement (the “TLA”), with Hefei Tianhui Incubator of Technologies Co. Ltd. (“HTIT”) and on December 21, 2015, the parties entered into an Amended and Restated Technology License Agreement that was further amended by the parties on June 3, 2016 and July 24, 2016 (the “HTIT License Agreement”). The HTIT License Agreement and a Stock Purchase Agreement, dated November 30, 2015, between the Company and HTIT (the “SPA”) were considered a single arrangement with multiple deliverables. The Company allocated the total consideration of $49,500 between the HTIT License Agreement and the SPA according to their fair value, as follows: $10,617 was allocated to the issuance of common stock (less issuance expenses of $23), based on the quoted price of the Company’s shares on the closing date of the SPA on December 28, 2015, and $38,883 was allocated to the HTIT License Agreement. Under Accounting Standard Codification, (“ASC”) 606, the Company identified a single performance obligation in the agreement and determined that the license and services are not distinct as the license and services are highly dependent on each other. In other words, HTIT cannot benefit from the license without the related services, and vice versa. Since the customer benefits from the services as the entity performs, revenue is recognized over time through the expected product submission date in June 2023, using the input method. The Company used the input method to measure the process for the purpose of recognizing revenue, which approximates the straight line attribution. The Company used significant judgment when it determined the product submission date. Under ASC 606, the consideration that the Company would be entitled to upon the achievement of contractual milestones, which are contingent upon the occurrence of future events, are a form of variable consideration. When assessing the portion, if any, of such milestones-related consideration to be included in the transaction price, the Company first assesses the most likely outcome for each milestone and excludes the consideration related to milestones of which the occurrence is not considered the most likely outcome. The Company then evaluates if any of the variable consideration determined in the first step is constrained by including in the transaction price variable consideration to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company used significant judgment when it determined the first step of variable consideration. The potential future royalty consideration is also considered a form of variable consideration under ASC 606 as it is based on a percentage of potential future sales of the Company’s products. However, the Company applies the sales-based royalty exception and accordingly will recognize the sales-based royalty amounts when the related sale has occurred. To date, the Company has not recognized any royalty-related revenue. As of March 31, 2023, an aggregate amount of $22,382 was allocated to the HTIT License Agreement, all of which were received through the balance sheet date. Through March 31, 2023, the Company recognized revenue associated with this agreement in the aggregate amount of $19,708, of which $666 was recognized in the quarter ended March 31, 2023, and deferred the remaining amount of $2,674, which is presented as a contract liability on the condensed consolidated balance sheet. Medicox On November 13, 2022, the Company entered into a distribution license agreement (“Medicox License Agreement”) with Medicox Co., Ltd. (“Medicox”). The Medicox License Agreement grants Medicox an exclusive license to apply for regulatory approval and distribute ORMD-0801 in the Republic of Korea. For further details, see note 3c. Under ASC 606, the Company identified Medicox as a customer and the Medicox License Agreement as a contract with a customer. The Company identified a performance obligation in the Medicox License Agreement to stand-ready and provide Medicox with support in its commercialization efforts in the Republic of Korea. This performance obligation includes a non-distinct distribution license for ORMD-0801, which the Company views a predominant item in the combined performance obligation. The Company concluded that the license is not distinct, as no party other than the Company is capable of providing related services to Medicox, and both the license and related services are necessary for the customer to obtain a regulatory approval in the Republic of Korea. In addition, the agreement covers the terms of future manufacturing services, that are contingent on the completion and success of the commercialization efforts. The Medicox License Agreement contains a fixed consideration of $2,000, which was received by the Company in fiscal year 2022 and is presented under long-term deferred revenues as of March 31, 2023. It also contains variable consideration of contractual milestone payments and sales-based royalties. The Company’s obligation to stand-ready and support Medicox will be recognized on a straight-line basis over the period the Company expects to provide support to Medicox. As of March 31, 2023, this support has not commenced, and no revenue was recognized from the Medicox License Agreement. If Medicox proceeds with the regulatory approval process in the Republic of Korea, the Company expects most of the revenue to be recognized in 2024, going forward. The Company notes that its Phase 3 trial did not meet its primary and secondary endpoints. If Medicox chooses to terminate the agreement as a result of the outcome of the applicable Phase 3 trials, the Company expects to accelerate revenue recognition and recognize it at such time. d. Recently adopted accounting pronouncements Financial instruments – credit losses In June 2016, the Financial Accounting Standards Board issued Accounting Standards Update 2016-13 “Financial Instruments—Credit Losses—Measurement of Credit Losses on Financial Instruments.” This guidance replaces the 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 became effective for the fiscal year beginning after December 15, 2022, including interim periods within that year. The Company adopted the provisions of this update as of January 1, 2023, with no material impact on its consolidated financial statements. e. Fair value The Company measures fair value and discloses fair value measurements for financial assets and liabilities. Fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, the guidance establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described as follows: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level Observable prices that are based on inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. As of March 31, 2023, the assets measured at fair value are comprised of equity securities (Level 1). The fair value of held to maturity bonds as presented in note 4 was based on a Level 2 measurement. As of March 31, 2023, 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.

Commitments

Commitments	3 Months Ended
	Mar. 31, 2023
Commitments and Contingencies Disclosure [Abstract]
COMMITMENTS	NOTE 3 - COMMITMENTS a. 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 up to $22,684 during the term of the engagement and based on achievement of certain milestones, of which $16,600 was recognized in research and development expenses through March 31, 2023 . On January 11, 2023, the Company announced that the ORA-D-013-1 Phase 3 trial did not meet its primary and secondary endpoints. As a result, the Company terminated this trial. b. 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 up to $15,796 during the term of the engagement and based on achievement of certain milestones, of which $7,972 was recognized in research and development expenses through March 31, 2023. On January 11, 2023, the Company announced that the ORA-D-013-1 Phase 3 trial did not meet its primary and secondary endpoints. As a result, the Company terminated this trial and a parallel Phase 3, ORA-D-013-2 clinical trial. c. On November 13, 2022, the Company entered the Medicox License Agreement with Medicox. The Medicox License Agreement grants Medicox an exclusive license to apply for regulatory approval and distribute ORMD-0801 in the Republic of Korea. The Medicox License Agreement is for ten years, but the parties have the right to terminate it upon 180 days’ notice. Medicox will comply with agreed distribution targets and will purchase ORMD-0801 at an agreed upon transfer price per capsule. In addition, Medicox will pay the Company up to $15,000 in developmental milestones, $2,000 of which have already been received by the Company, and up to 15% royalties on gross sales. Medicox will also be responsible for obtaining a regulatory approval in the Republic of Korea. The Company is currently evaluating with Medicox a path forward to continue its collaboration, following the results of the ORA-D-013-1 Phase 3 trial. For the Company’s revenue recognition policy, see note 2c. d. Grants from the Israel Innovation Authority (“IIA”) Under the terms of the Company’s funding from the IIA, royalties of 3% are payable on sales of products developed from a project so funded, up to a maximum amount equaling 100%-150% of the grants received (dollar linked) with the addition of interest at an annual rate based on LIBOR. At the time the grants were received, successful development of the related projects was not assured. The total amount received through March 31, 2023 was $2,208 ($2,542 including interest). As of March 31, 2023, the liability to the IIA was $96. The royalty expenses which are related to the funded project were recognized in cost of revenues in the relevant periods.

Marketable Securities

Marketable Securities	3 Months Ended
	Mar. 31, 2023
Marketable Securities [Abstract]
MARKETABLE SECURITIES	NOTE 4 - MARKETABLE SECURITIES: The Company’s marketable securities include investments in equity securities of DNA GROUP (T.R.) Ltd. (formerly D.N.A Biomedical Solutions Ltd.) (“DNA”), Entera Bio Ltd. (“Entera”) and in held to maturity securities. a. Composition: March 31, December 31, Short-term: DNA (see b below) $ 366 $ 352 Entera (see c below) 136 85 Held to maturity securities (see d below) 1,765 3,306 $ 2,267 $ 3,743 b. DNA The DNA ordinary shares are traded on the Tel Aviv Stock Exchange. The fair value of those securities is measured at the quoted prices of the securities on the measurement date. During the three month period ended March 31, 2023, the Company did not sell any of DNA’s ordinary shares. As of March 31, 2023, the Company owns approximately 1.4% of DNA’s outstanding ordinary shares. The cost of the securities as of both March 31, 2023 and December 31, 2022 was $595. c. Entera Entera ordinary shares have been traded on The Nasdaq Capital Market since June 28, 2018. The Company measures the investment at fair value from such date, since it has a readily determinable fair value (prior to such date the investment was accounted for as a cost method investment (amounting to $1)). d. Held to maturity securities The amortized cost and estimated fair value of held to maturity securities as of March 31, 2023, were as follows: March 31, 2023 Amortized Gross Estimated Average Short-term: Commercial bonds $ 1,738 $ (40 ) $ 1,698 0.84 % Accrued interest 27 - 27 $ 1,765 $ (40 ) $ 1,725 The amortized cost and estimated fair value of held to maturity securities as of December 31, 2022, were as follows: December 31, 2022 Amortized Gross Estimated Average yield to Short-term: Commercial bonds $ 3,258 $ (82 ) $ 3,176 1.07 % Accrued interest 48 - 48 $ 3,306 $ (82 ) $ 3,224 Held to maturity securities which will mature during the 12 months from the balance sheet date are included in short-term marketable securities.

Stockholders' Equity

Stockholders' Equity	3 Months Ended
	Mar. 31, 2023
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 the Company’s effective shelf registration statement on Form S-3 including a prospectus dated July 26, 2021 and prospectus supplement dated September 1, 2021. The Company paid the sales agent a cash commission of 3.0% of the gross proceeds of the sale of any shares sold through the sales agent under the Cantor Equity Distribution Agreement. As of March 31, 2023 and May 11, 2023, 1,971,447 shares were issued under the Cantor Equity Distribution Agreement for aggregate net proceeds of $26,253.

Leases

Leases	3 Months Ended
	Mar. 31, 2023
Leases [Abstract]
LEASES	NOTE 6 - LEASES: The Company has various operating leases for office space and vehicles that expire through 2027. Below is a summary of the Company’s operating right-of-use assets and operating lease liabilities as of March 31, 2023 and December 31, 2022: March 31, 2023 December 31, Operating right-of-use assets $ 915 $ 987 Operating lease liabilities, current 242 247 Operating lease liabilities long-term 564 647 Total operating lease liabilities $ 806 $ 894 Lease payments for the Company’s right-of-use assets over the remaining lease periods as of March 31, 2023 and December 31, 2022 are as follows: March 31, 2023 December 31, 2023 212 291 2024 283 291 2025 222 228 2026 120 124 2027 10 10 Total undiscounted lease payments 847 944 Less: Interest* (41 ) (50 ) Present value of lease liabilities $ 806 $ 894 * Future lease payments were discounted by 3%-5.75% interest rate.

Related Party Transactions

Related Party Transactions	3 Months Ended
	Mar. 31, 2023
Related Party Transactions [Abstract]
RELATED PARTY TRANSACTIONS	NOTE 7 - RELATED PARTY TRANSACTIONS: On July 1, 2008, the Subsidiary entered into two consulting agreements with KNRY Ltd. (“KNRY”), an Israeli company owned by the Chief Scientific Officer, whereby the President and Chief Executive Officer and the Chief Scientific Officer, through KNRY, provide services to the Company (the “Consulting Agreements”). The Consulting Agreements are both terminable by either party upon 140 days prior written notice. The Consulting Agreements, as amended, provide that KNRY will be reimbursed for reasonable expenses incurred in connection with the performance of the Consulting Agreements and that the monthly consulting fee paid to the President and Chief Executive Officer and the Chief Scientific Officer is NIS 146,705 ($41) and NIS 106,400 ($29), respectively. In addition to the Consulting Agreements, based on a relocation cost analysis, the Company paid for certain direct costs, related taxes and expenses incurred in connection with the relocation of the President and Chief Executive Officer to the U.S. During the three months ended March 31, 2023, there were no Following the relocation of the President and Chief Executive Officer to the State of Israel, the Company entered into two agreements with the President and Chief Executive Officer, replacing his above-mentioned consulting agreement through KNRY, substantially on the same terms, in order to allocate his time and services between the Company and the Subsidiary. Effective November 1, 2022, the Company entered into a consulting agreement with Shnida Ltd., whereby the President and Chief Executive Officer, through Shnida Ltd., provides services as President and Chief Executive Officer of the Company. The agreement is terminable by either party upon 140 days prior written notice. The agreement provides that Shnida Ltd. will be reimbursed for reasonable expenses incurred in connection with performance of the agreement and that the President and Chief Executive Officer will receive a monthly consulting fee of NIS 88,023 ($24), plus value added tax. Pursuant to the agreement, Shnida Ltd. and the President and Chief Executive Officer each agree that during the term of the agreement and for a 12-month period thereafter, none of them will compete with the Company nor solicit employees of the Company. In addition, the Company, through the Subsidiary, has entered into an employment agreement with the President and Chief Executive Officer, effective as of November 1, 2022, pursuant to which the President and Chief Executive Officer receives gross monthly salary of NIS 46,901 ($13) in consideration for his services as President and Chief Executive Officer of the Subsidiary. In addition, the President and Chief Executive Officer is provided with a cellular phone and a company car pursuant to the terms of his agreement.

Subsequent Events

Subsequent Events	3 Months Ended
	Mar. 31, 2023
Subsequent Events [Abstract]
SUBSEQUENT EVENTS	NOTE 8 - SUBSEQUENT EVENTS: 1. On April 17, 2023, the Company granted an aggregate of 868,500 RSUs representing a right to receive shares of the Company’s common stock to executive officers and board members of the Company. The RSUs will vest in twelve equal quarterly installments starting May 1, 2023. The total fair value of these RSUs on the date of grant was $1,980, using the quoted closing market share price of $2.28 on the Nasdaq Capital Market on the date of grant. 2. On April 17, 2023, the Company granted an aggregate of 245,500 performance based RSUs (“PSUs”) representing a right to receive shares of the Company’s common stock to executive officers of the Company. The PSUs will vest upon the Company’s common stock achieving and maintaining a specified price per share. The total fair value of these PSUs on the date of grant was $550, using the Monte-Carlo model. 3. On May 1, 2023, the Company granted an aggregate of 20,000 RSUs representing a right to receive shares of the Company’s common stock to a board member. The RSUs will vest in twelve quarterly installments starting May 1, 2023. The total fair value of these RSUs on the date of grant was $49, using the quoted closing market share price of $2.45 on the Nasdaq Capital Market on the date of grant.

Accounting Policies, by Policy

Accounting Policies, by Policy (Policies)	3 Months Ended
	Mar. 31, 2023
General [Abstract]
Condensed consolidated financial statements preparation	a. Condensed consolidated financial statements preparation The condensed consolidated financial statements included herein have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) and, on the same basis as the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022 (the “2022 Form 10-K”). These condensed consolidated financial statements reflect all adjustments that are of a normal recurring nature and that are considered necessary for a fair statement of the results of the periods presented. Certain information and disclosures normally included in annual consolidated financial statements have been omitted in this interim period report pursuant to the rules and regulations of the Securities and Exchange Commission. Because the condensed consolidated interim financial statements do not include all of the information and disclosures required by U.S. GAAP for annual financial statements, they should be read in conjunction with the audited consolidated financial statements and notes included in the 2022 Form 10-K. The results for interim periods are not necessarily indicative of a full fiscal year’s results.
Loss per common share	b. Loss per common share Basic and diluted net loss per share of common stock are computed by dividing the net loss attributable to stockholders for the period by the weighted average number of shares of common stock outstanding for each period, including vested restricted stock units (“RSUs”). Outstanding stock options, warrants and unvested RSUs have been excluded from the calculation of the diluted loss per share because all such securities are anti-dilutive for all periods presented. The weighted average number of common stock options, warrants and RSUs excluded from the calculation of diluted net loss was 3,357,911 and 3,463,525 for the three month periods ended March 31, 2023 and March 31, 2022, respectively.
Revenue recognition	c. Revenue recognition HTIT On November 30, 2015, the Company entered into a Technology License Agreement (the “TLA”), with Hefei Tianhui Incubator of Technologies Co. Ltd. (“HTIT”) and on December 21, 2015, the parties entered into an Amended and Restated Technology License Agreement that was further amended by the parties on June 3, 2016 and July 24, 2016 (the “HTIT License Agreement”). The HTIT License Agreement and a Stock Purchase Agreement, dated November 30, 2015, between the Company and HTIT (the “SPA”) were considered a single arrangement with multiple deliverables. The Company allocated the total consideration of $49,500 between the HTIT License Agreement and the SPA according to their fair value, as follows: $10,617 was allocated to the issuance of common stock (less issuance expenses of $23), based on the quoted price of the Company’s shares on the closing date of the SPA on December 28, 2015, and $38,883 was allocated to the HTIT License Agreement. Under Accounting Standard Codification, (“ASC”) 606, the Company identified a single performance obligation in the agreement and determined that the license and services are not distinct as the license and services are highly dependent on each other. In other words, HTIT cannot benefit from the license without the related services, and vice versa. Since the customer benefits from the services as the entity performs, revenue is recognized over time through the expected product submission date in June 2023, using the input method. The Company used the input method to measure the process for the purpose of recognizing revenue, which approximates the straight line attribution. The Company used significant judgment when it determined the product submission date. Under ASC 606, the consideration that the Company would be entitled to upon the achievement of contractual milestones, which are contingent upon the occurrence of future events, are a form of variable consideration. When assessing the portion, if any, of such milestones-related consideration to be included in the transaction price, the Company first assesses the most likely outcome for each milestone and excludes the consideration related to milestones of which the occurrence is not considered the most likely outcome. The Company then evaluates if any of the variable consideration determined in the first step is constrained by including in the transaction price variable consideration to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. The Company used significant judgment when it determined the first step of variable consideration. The potential future royalty consideration is also considered a form of variable consideration under ASC 606 as it is based on a percentage of potential future sales of the Company’s products. However, the Company applies the sales-based royalty exception and accordingly will recognize the sales-based royalty amounts when the related sale has occurred. To date, the Company has not recognized any royalty-related revenue. As of March 31, 2023, an aggregate amount of $22,382 was allocated to the HTIT License Agreement, all of which were received through the balance sheet date. Through March 31, 2023, the Company recognized revenue associated with this agreement in the aggregate amount of $19,708, of which $666 was recognized in the quarter ended March 31, 2023, and deferred the remaining amount of $2,674, which is presented as a contract liability on the condensed consolidated balance sheet. Medicox On November 13, 2022, the Company entered into a distribution license agreement (“Medicox License Agreement”) with Medicox Co., Ltd. (“Medicox”). The Medicox License Agreement grants Medicox an exclusive license to apply for regulatory approval and distribute ORMD-0801 in the Republic of Korea. For further details, see note 3c. Under ASC 606, the Company identified Medicox as a customer and the Medicox License Agreement as a contract with a customer. The Company identified a performance obligation in the Medicox License Agreement to stand-ready and provide Medicox with support in its commercialization efforts in the Republic of Korea. This performance obligation includes a non-distinct distribution license for ORMD-0801, which the Company views a predominant item in the combined performance obligation. The Company concluded that the license is not distinct, as no party other than the Company is capable of providing related services to Medicox, and both the license and related services are necessary for the customer to obtain a regulatory approval in the Republic of Korea. In addition, the agreement covers the terms of future manufacturing services, that are contingent on the completion and success of the commercialization efforts. The Medicox License Agreement contains a fixed consideration of $2,000, which was received by the Company in fiscal year 2022 and is presented under long-term deferred revenues as of March 31, 2023. It also contains variable consideration of contractual milestone payments and sales-based royalties. The Company’s obligation to stand-ready and support Medicox will be recognized on a straight-line basis over the period the Company expects to provide support to Medicox. As of March 31, 2023, this support has not commenced, and no revenue was recognized from the Medicox License Agreement. If Medicox proceeds with the regulatory approval process in the Republic of Korea, the Company expects most of the revenue to be recognized in 2024, going forward. The Company notes that its Phase 3 trial did not meet its primary and secondary endpoints. If Medicox chooses to terminate the agreement as a result of the outcome of the applicable Phase 3 trials, the Company expects to accelerate revenue recognition and recognize it at such time.
Recently adopted accounting pronouncements	d. Recently adopted accounting pronouncements Financial instruments – credit losses In June 2016, the Financial Accounting Standards Board issued Accounting Standards Update 2016-13 “Financial Instruments—Credit Losses—Measurement of Credit Losses on Financial Instruments.” This guidance replaces the 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 became effective for the fiscal year beginning after December 15, 2022, including interim periods within that year. The Company adopted the provisions of this update as of January 1, 2023, with no material impact on its consolidated financial statements.
Fair value	e. Fair value The Company measures fair value and discloses fair value measurements for financial assets and liabilities. Fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, the guidance establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described as follows: Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. Level Observable prices that are based on inputs other than quoted prices included within Level 1 that are observable for the asset or liability, either directly or indirectly. Level 3: Unobservable inputs are used when little or no market data is available. The fair value hierarchy gives the lowest priority to Level 3 inputs. As of March 31, 2023, the assets measured at fair value are comprised of equity securities (Level 1). The fair value of held to maturity bonds as presented in note 4 was based on a Level 2 measurement. As of March 31, 2023, 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.

Marketable Securities (Tables)

Marketable Securities (Tables)	3 Months Ended
	Mar. 31, 2023
Marketable Securities [Abstract]
Schedule of marketable securities include investments in equity securities	March 31, December 31, Short-term: DNA (see b below) $ 366 $ 352 Entera (see c below) 136 85 Held to maturity securities (see d below) 1,765 3,306 $ 2,267 $ 3,743
Schedule of amortized cost and estimated fair value of held-to-maturity securities	March 31, 2023 Amortized Gross Estimated Average Short-term: Commercial bonds $ 1,738 $ (40 ) $ 1,698 0.84 % Accrued interest 27 - 27 $ 1,765 $ (40 ) $ 1,725 December 31, 2022 Amortized Gross Estimated Average yield to Short-term: Commercial bonds $ 3,258 $ (82 ) $ 3,176 1.07 % Accrued interest 48 - 48 $ 3,306 $ (82 ) $ 3,224

Leases (Tables)

Leases (Tables)	3 Months Ended
	Mar. 31, 2023
Leases [Abstract]
Schedule of operating right-of-use assets and operating lease liabilities	March 31, 2023 December 31, Operating right-of-use assets $ 915 $ 987 Operating lease liabilities, current 242 247 Operating lease liabilities long-term 564 647 Total operating lease liabilities $ 806 $ 894
Schedule of right-of-use assets over the remaining lease periods	March 31, 2023 December 31, 2023 212 291 2024 283 291 2025 222 228 2026 120 124 2027 10 10 Total undiscounted lease payments 847 944 Less: Interest* (41 ) (50 ) Present value of lease liabilities $ 806 $ 894 * Future lease payments were discounted by 3%-5.75% interest rate.

General (Details)

General (Details)	3 Months Ended
	Mar. 31, 2023 shares
General [Abstract]
Capital stock issued	1,890,000
Shares issued and outstanding percentage	63%

Significant Accounting Polici_2

Significant Accounting Policies (Details) - USD ($) $ in Thousands	1 Months Ended	3 Months Ended
	Dec. 28, 2015	Mar. 31, 2023	Mar. 31, 2022
Significant Accounting Policies (Details) [Line Items]
Diluted net loss (in Shares)		3,357,911	3,463,525
Fixed consideration		$ 2,000
Recognized revenue aggregate amount		19,708
Deferred revenue recognized		666
Deferred revenue recognized remaining amount		2,674
HTIT License Agreement [Member]
Significant Accounting Policies (Details) [Line Items]
Fixed consideration	$ 49,500
Value of common stock issued	38,883	$ 22,382
Stock Purchase Agreement [Member]
Significant Accounting Policies (Details) [Line Items]
Value of common stock issued	10,617
issuance expenses	$ 23

Commitments (Details)

Commitments (Details) - USD ($) $ in Thousands			3 Months Ended
	Nov. 13, 2022	Sep. 02, 2020	Mar. 31, 2023
Commitments (Details) [Line Items]
License agreement, description			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 up to $15,796 during the term of the engagement and based on achievement of certain milestones, of which $7,972 was recognized in research and development expenses through March 31, 2023.
Right terminate years	10 years
Development amount			$ 15,000
Development received amount			$ 2,000
Royalty percentage			15%
Total amount received			$ 2,208
Liability			$ 96
Israel Innovation Authority [Member]
Commitments (Details) [Line Items]
Royalty percentage			3%
Minimum [Member] | Israel Innovation Authority [Member]
Commitments (Details) [Line Items]
Royalty percentage			100%
Maximum [Member] | Israel Innovation Authority [Member]
Commitments (Details) [Line Items]
Royalty percentage			150%
Vendor Two [Member]
Commitments (Details) [Line Items]
Commitments for considering service		$ 22,684
Research and development expenses			$ 16,600
LIBOR [Member]
Commitments (Details) [Line Items]
Total amount received			$ 2,542

Marketable Securities (Details)

Marketable Securities (Details) - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Marketable Securities (Details) [Line Items]
Cost of securities	$ 595	$ 595
Cost method investments	$ 1
Equity Method Investment [Member]
Marketable Securities (Details) [Line Items]
Ownership percentage	1.40%

Marketable Securities (Detail_2

Marketable Securities (Details) - Schedule of marketable securities include investments in equity securities - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Schedule Of Marketable Securities Include Investments In Equity Securities Abstract
DNA (see b below)	$ 366	$ 352
Entera (see c below)	136	85
Held to maturity securities (see d below)	1,765	3,306
Marketable securities	$ 2,267	$ 3,743

Marketable Securities (Detail_3

Marketable Securities (Details) - Schedule of amortized cost and estimated fair value of held-to-maturity securities - USD ($) $ in Thousands	3 Months Ended
	Mar. 31, 2023	Mar. 31, 2022
Schedule of Held-to-Maturity Securities [Line Items]
Amortized cost	$ 1,765	$ 3,306
Gross unrealized gains (losses)	(40)	(82)
Estimated fair value	1,725	3,224
Commercial bonds [Member]
Schedule of Held-to-Maturity Securities [Line Items]
Amortized cost	1,738	3,258
Gross unrealized gains (losses)	(40)	(82)
Estimated fair value	$ 1,698	$ 3,176
Average yield to maturity rate	0.84%	1.07%
Accrued Interest [Member]
Schedule of Held-to-Maturity Securities [Line Items]
Amortized cost	$ 27	$ 48
Gross unrealized gains (losses)
Estimated fair value	$ 27	$ 48

Stockholders' Equity (Details)

Stockholders' Equity (Details) - USD ($)			3 Months Ended
	May 11, 2023	Sep. 01, 2021	Mar. 31, 2023
Stockholders' Equity (Details) [Line Items]
Aggregate offering price		$ 100,000
Cash commission percentage		3%
Shares issued (in Shares)			1,971,447
Aggregate net proceeds			$ 26,253
Subsequent Event [Member]
Stockholders' Equity (Details) [Line Items]
Shares issued (in Shares)	1,971,447
Aggregate net proceeds	$ 26,253

Leases (Details)

Leases (Details)	Mar. 31, 2023
Minimum [Member]
Leases (Details) [Line Items]
Future lease payments rate	3%
Maximum [Member]
Leases (Details) [Line Items]
Future lease payments rate	5.75%

Leases (Details) - Schedule of

Leases (Details) - Schedule of operating right-of-use assets and operating lease liabilities - USD ($) $ in Thousands	Mar. 31, 2023	Dec. 31, 2022
Schedule of Operating Right of Use Assets and Operating Lease Liabilities [Abstract]
Operating right-of-use assets	$ 915	$ 987
Operating lease liabilities, current	242	247
Operating lease liabilities long-term	564	647
Total operating lease liabilities	$ 806	$ 894

Leases (Details) - Schedule o_2

Leases (Details) - Schedule of right-of-use assets over the remaining lease periods - USD ($) $ in Thousands		Mar. 31, 2023	Mar. 31, 2022
Schedule of Right of Use Assets Over the Remaining Lease Periods [Abstract]
2023		$ 212	$ 291
2024		283	291
2025		222	228
2026		120	124
2027		10	10
Total undiscounted lease payments		847	944
Less: Interest	[1]	(41)	(50)
Present value of lease liabilities		$ 806	$ 894
[1] Future lease payments were discounted by 3%-5.75% interest rate.

Related Party Transactions (Det

Related Party Transactions (Details) $ in Thousands	1 Months Ended				3 Months Ended
	Nov. 01, 2022 USD ($)	Nov. 01, 2022 ILS (₪)	Jul. 01, 2008 USD ($)	Jul. 01, 2008 ILS (₪)	Mar. 31, 2023 USD ($)	Mar. 31, 2022 USD ($)
Related Party Transactions (Details) [Line Items]
Consulting fee paid	$ 24	₪ 88,023
Relocation expenses | $						$ 143
Gross salary	$ 13	₪ 46,901
Chief Executive Officer [Member]
Related Party Transactions (Details) [Line Items]
Consulting fee paid			$ 41	₪ 146,705
Chief Scientific Officer [Member]
Related Party Transactions (Details) [Line Items]
Consulting fee paid | ₪				₪ 29

Subsequent Events (Details)

Subsequent Events (Details) - Subsequent Event [Member] - USD ($) $ / shares in Units, $ in Thousands		1 Months Ended
	May 01, 2023	Apr. 17, 2023
Subsequent Events (Details) [Line Items]
Aggregate of restricted stock units		245,500
RSUs on the date of grant		$ 550
Forecast [Member]
Subsequent Events (Details) [Line Items]
Aggregate of restricted stock units	20,000
RSUs on the date of grant	$ 49
Market share price	$ 2.45
Restricted Stock Units (RSUs) [Member]
Subsequent Events (Details) [Line Items]
Aggregate of restricted stock units		868,500
RSUs on the date of grant		$ 1,980
Market share price		$ 2.28