UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 10-Q

☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended November 30, ~~2017~~2021

☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

Commission file number: ~~000-50298~~001-35813

ORAMED PHARMACEUTICALS INC.

(Exact Name of Registrant as Specified in Its Charter)

Delaware		98-0376008
(State or Other Jurisdiction of Incorporation or Organization)		(I.R.S. Employer Identification No.)

~~Hi-Tech Park 2/4 Givat Ram~~ ~~PO Box 39098~~ ~~Jerusalem, Israel~~		~~91390~~

1185 Avenue of the Americas, Third Floor, New York, NY		10036
(Address of Principal Executive Offices)		(Zip Code)

~~+ 972-2-566-0001~~844-967-2633

(Registrant’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading symbol		Name of each exchange on which registered
Common Stock, par value $0.012		ORMP		The Nasdaq Capital Market, Tel Aviv Stock Exchange

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.

Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically ~~and posted on its corporate Web site, if any,~~ every Interactive Data File required to be submitted ~~and posted~~ pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit ~~and post~~ such files).

Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

☐

Accelerated filer

☐

Non-accelerated filer

~~☐ (Do not check if a smaller reporting company)~~☒

Smaller reporting company

☒

Emerging growth company

☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes ☐ No ☒

As of January ~~10, 2018,~~11, 2022, there were ~~14,370,930~~38,283,841 shares of the issuer’s common stock, $0.012 par value per share, outstanding.

ORAMED PHARMACEUTICALS INC.

FORM 10-Q

TABLE OF CONTENTS

PART I - FINANCIAL INFORMATION	1

ITEM 1 - FINANCIAL STATEMENTS	1

ITEM 2 - MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS	1716

ITEM 3 - QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK	2425

ITEM 4 - CONTROLS AND PROCEDURES	2425

PART II - OTHER INFORMATION	2526
~~ITEM 2 - UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS~~	25
ITEM 6 - EXHIBITS	2526

As used in this Quarterly Report on Form 10-Q, the terms “we,” “us,” “our” and the “Company” mean Oramed Pharmaceuticals Inc. and our wholly-owned ~~Israeli subsidiary, Oramed Ltd.,~~subsidiaries, unless otherwise indicated. All dollar amounts refer to U.S. Dollars unless otherwise indicated.

On November 30, ~~2017,~~2021, the exchange rate between the New Israeli Shekel, or NIS, and the dollar, as quoted by the Bank of Israel, was NIS ~~3.499~~3.162 to $1.00. Unless indicated otherwise by the context, statements in this Quarterly Report on Form 10-Q that provide the dollar equivalent of NIS amounts or provide the NIS equivalent of dollar amounts are based on such exchange rate.

PART I – FINANCIAL INFORMATION

ITEM 1 - FINANCIAL STATEMENTS

ORAMED PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

AS OF NOVEMBER 30, ~~2017~~2021

TABLE OF CONTENTS

	Page
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS:
Balance sheets	2
Statements of comprehensive loss	3
~~Statement~~Statements of changes in stockholders’ equity	4
Statements of cash flows	5
Notes to financial statements	~~6-16~~6-15

ORAMED PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

U.S. Dollars in thousands (except share and per share data)

(UNAUDITED)

November 30, August 31,
2017 2017
Assets
CURRENT ASSETS:
Cash and cash equivalents $ 1,258 $ 3,969
Short-term deposits 14,992 13,293
Marketable securities 2,722 2,860
Restricted cash - 16
Prepaid expenses and other current assets 163 159
Total current assets 19,135 20,297

LONG-TERM ASSETS:
Long-term deposits and investment 17,780 16,232
Marketable securities 4,598 2,151
Amounts funded in respect of employee rights upon retirement 14 14
Property and equipment, net 17 18
Total long-term assets 22,409 18,415
Total assets $ 41,544 $ 38,712

Liabilities and stockholders’ equity

CURRENT LIABILITIES:
Accounts payable and accrued expenses $ 2,599 $ 2,716
Deferred revenues 2,449 2,449
Payable to related parties 76 -
Total current liabilities 5,124 5,165

LONG-TERM LIABILITIES:
Deferred revenues 13,226 13,837
Employee rights upon retirement 19 18
Provision for uncertain tax position 11 11
Other liabilities 423 443
Total long-term liabilities 13,679 14,309

COMMITMENTS (note 2)

STOCKHOLDERS’ EQUITY:
Common stock, $0.012 par value (30,000,000 authorized shares; 14,307,890 and 13,668,530 shares issued and outstanding as of November 30, 2017 and August 31, 2017, respectively) 170 163
Additional paid-in capital 80,871 75,170
Accumulated other comprehensive income 727 401
Accumulated loss (59,027 ) (56,496 )
Total stockholders’ equity 22,741 19,238
Total liabilities and stockholders’ equity $ 41,544 $ 38,712

	November 30,			August 31,
	2021			2021
Assets
CURRENT ASSETS:
Cash and cash equivalents	$	31,880		$	77,245
Short-term deposits		111,082			11,044
Marketable securities		7,573			5,851
Prepaid expenses and other current assets		1,797			1,197
Total current assets		152,332			95,337

LONG-TERM ASSETS:
Long-term deposits		25,074			25,016
Marketable securities		4,131			6,692
Amounts funded in respect of employee rights upon retirement		24			24
Property and equipment, net		385			397
Operating lease right-of-use assets		504			533
Total long-term assets		30,118			32,662
Total assets	$	182,450		$	127,999

Liabilities and stockholders’ equity

CURRENT LIABILITIES:
Accounts payable and accrued expenses	$	4,761		$	3,792
Deferred revenues		2,703			2,703
Payable to related parties		66			54
Operating lease liabilities		130			130
Total current liabilities		7,660			6,679

LONG-TERM LIABILITIES:
Long-term deferred revenues		3,570			4,244
Employee rights upon retirement		22			21
Provision for uncertain tax position		11			11
Operating lease liabilities		374			403
Other liabilities		122			124
Total long-term liabilities		4,099			4,803

COMMITMENTS (note 2)

EQUITY
EQUITY ATTRIBUTABLE TO COMPANY’S STOCKHOLDERS:
Common stock, $0.012 par value (60,000,000 authorized shares; 38,086,020 and 35,293,889 shares issued and outstanding as of November 30, 2021 and August 31, 2021, respectively)		458			424
Additional paid-in capital		292,439			230,201
Accumulated deficit		(122,742	)		(114,852	)
Total stockholders’ equity		170,155			115,773
Non-controlling interests		536			744
Total equity		170,691			116,517
Total liabilities and equity	$	182,450		$	127,999

The accompanying notes are an integral part of the condensed consolidated financial statements.

ORAMED PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

U.S. Dollars in thousands (except share and per share data)

(UNAUDITED)

Three months ended
November 30, November 30,
2017 2016

REVENUES $ 611 $ 610
COST OF REVENUES - 187
RESEARCH AND DEVELOPMENT EXPENSES, NET 2,327 2,353
GENERAL AND ADMINISTRATIVE EXPENSES 1,016 468
OPERATING LOSS 2,732 2,398
FINANCIAL INCOME 222 186
FINANCIAL EXPENSES 21 24
LOSS BEFORE TAXES ON INCOME 2,531 2,236
TAXES ON INCOME - 400
NET LOSS FOR THE PERIOD $ 2,531 $ 2,636

UNREALIZED LOSS (GAIN) ON AVAILABLE FOR SALE SECURITIES (326 ) 63
TOTAL OTHER COMPREHENSIVE LOSS (GAIN) (326 ) 63
TOTAL COMPREHENSIVE LOSS FOR THE PERIOD $ 2,205 $ 2,699

LOSS PER SHARE OF COMMON STOCK:
BASIC AND DILUTED LOSS PER SHARE OF COMMON STOCK $ 0.18 $ 0.20
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING BASIC AND DILUTED LOSS PER SHARE OF COMMON STOCK 14,239,346 13,205,971

	Three months ended
	November 30,			November 30,
	2021			2020
REVENUES	$	674			674
RESEARCH AND DEVELOPMENT EXPENSES		6,410			5,774
SALES AND MARKETING EXPENSES		585			-
GENERAL AND ADMINISTRATIVE EXPENSES		1,739			727
OPERATING LOSS		8,060			5,827
FINANCIAL INCOME		(137	)		(269	)
FINANCIAL EXPENSES		175			12
NET LOSS FOR THE PERIOD	$	8,098			5,570
NET LOSS ATTRIBUTABLE TO NON-CONTROLLING INTERESTS		208			-
NET LOSS ATTRIBUTABLE TO STOCKHOLDERS		7,890			5,570
LOSS PER SHARE OF COMMON STOCK ATTRIBUTABLE TO COMMON STOCKHOLDERS:
BASIC AND DILUTED LOSS PER SHARE OF COMMON STOCK	$	0.22		$	0.23
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING BASIC AND DILUTED LOSS PER SHARE OF COMMON STOCK		36,672,551			23,754,980

The accompanying notes are an integral part of the condensed consolidated financial statements.

ORAMED PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED ~~STATEMENT~~STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

U.S. Dollars in thousands ~~(except share data)~~

(UNAUDITED)

Accumulated
Additional other Total
Common Stock paid-in comprehensive Accumulated stockholders’
Shares $ capital income loss equity
In thousands
BALANCE AS OF AUGUST 31, 2017 13,668 $ 163 $ 75,170 $ 401 $ (56,496 ) $ 19,238
CHANGES DURING THE THREE-MONTH PERIOD ENDED NOVEMBER 30, 2017:
SHARES ISSUED FOR SERVICES 3 * 24 - - 24
ISSUANCE OF COMMON STOCK, NET 454 5 4,225 - - 4,230
EXERCISE OF WARRANTS AND OPTIONS 178 2 928 - - 930
STOCK-BASED COMPENSATION 5 * 524 - - 524
NET LOSS - - - - (2,531 ) (2,531 )
OTHER COMPREHENSIVE INCOME - - - 326 - 326
BALANCE AS OF NOVEMBER 30, 2017 14,308 $ 170 $ 80,871 $ 727 $ (59,027 ) $ 22,741

	Common Stock				Additional paid-in		Accumulated			Total stockholders’			Non- controlling			Total
	Shares		$		capital		deficit			equity			interests			equity
	In thousands
BALANCE AS OF AUGUST 31, 2021		35,293	$	424	$	230,201	$	(114,852	)	$	115,773			744		$	116,517
CHANGES DURING THE THREE MONTH PERIOD ENDED NOVEMBER 30, 2021:
ISSUANCE OF COMMON STOCK, NET		2,631		32		59,908		-			59,940			-			59,940
EXERCISE OF WARRANTS AND OPTIONS		88		1		621		-			622			-			622
STOCK-BASED COMPENSATION		74		1		1,709		-			1,710			-			1,710
NET LOSS		-		-		-		(7,890	)		(7,890	)		(208	)		(8,098	)
BALANCE AS OF NOVEMBER 30, 2021		38,086	$	458	$	292,439	$	(122,742	)	$	170,155			536		$	170,691

					Additional					Total
	Common Stock				paid-in		Accumulated			stockholders’
	Shares		$		capital		deficit			equity
	In thousands
BALANCE AS OF AUGUST 31, 2020		23,675	$	284	$	125,209	$	(92,614	)	$	32,879
CHANGES DURING THE THREE MONTH PERIOD ENDED NOVEMBER 30, 2020:
ISSUANCE OF COMMON STOCK, NET		135		2		584		-			586
STOCK-BASED COMPENSATION		-		*		317		-			317
NET LOSS		-		-		-		(5,570	)		(5,570	)
BALANCE AS OF NOVEMBER 30, 2020		23,810	$	286	$	126,110	$	(98,184	)	$	28,212

* Represents an amount of less than $1.

Represents an amount of less than $1.

The accompanying notes are an integral part of the condensed consolidated financial statements.

ORAMED PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

U.S. dollars in thousands

(UNAUDITED)

Three months ended
November 30,
2017 2016
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss $ (2,531 ) $ (2,636 )
Adjustments required to reconcile net loss to net cash provided by (used in) operating activities:
Depreciation 1 1
Exchange differences and interest on deposits and held to maturity bonds (71 ) (112 )
Stock-based compensation 524 158
Shares issued for services 24 17
Changes in operating assets and liabilities:
Prepaid expenses and other current assets (4 ) (232 )
Accounts payable, accrued expenses and related parties (41 ) 825
Deferred revenues (611 ) 3,366
Liability for employee rights upon retirement 1 -
Other liabilities (20 ) 111
Total net cash provided by (used in) operating activities (2,728 ) 1,498
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of short-term deposits (2,039 ) (1,000 )
Purchase of long-term deposits (3,540 ) (3,000 )
Purchase of held to maturity securities (2,879 ) (1,056 )
Proceeds from sale of short-term deposits 2,455 1,320
Proceeds from maturity of held to maturity securities 857 300
Total net cash used in investing activities (5,146 ) (3,436 )
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock, net of issuance costs 4,230 -
Proceeds from exercise of warrants and options 930 320
Total net cash provided by financing activities 5,160 320
EFFECT OF EXCHANGE RATE CHANGES ON CASH 3 1
DECREASE IN CASH AND CASH EQUIVALENTS (2,711 ) (1,617 )
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD 3,969 3,907
CASH AND CASH EQUIVALENTS AT END OF PERIOD $ 1,258 $ 2,290

SUPPLEMENTARY DISCLOSURE ON CASH FLOWS -
Interest received $ 133 $ 56

	Three months ended
	November 30, 2021			November 30, 2020
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss	$	(8,098	)	$	(5,570	)
Adjustments required to reconcile net loss to net cash used in operating activities:
Depreciation		12			2
Exchange differences and interest on deposits and held to maturity bonds		(383	)		(114	)
Changes in fair value of investments		151			(162	)
Stock-based compensation		1,710			317
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		(600	)		(1,104	)
Accounts payable, accrued expenses and related parties		981			1,153
Deferred revenues		(674	)		(675	)
Liability for employee rights upon retirement		1			1
Other liabilities		(3	)		-
Total net cash used in operating activities		(6,903	)		(6,152	)
CASH FLOWS FROM INVESTING ACTIVITIES:
Investment in short-term deposits		(100,000	)		(7,460	)
Purchase of held to maturity securities		-			(658	)
Purchase of corporate bonds designated as fair value		-			(1,004	)
Proceeds from sale of short-term deposits		-			7,960
Proceeds from maturity of held to maturity securities		953			1,900
Proceeds from sale of mutual funds		-			775
Funds in respect of employee rights upon retirement		(1	)		(1	)
Purchase of property and equipment		-			(313	)
Total net cash provided by (used in) investing activities		(99,048	)		1,199
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock, net of issuance costs		59,940			586
Proceeds from exercise of options		623			-
Total net cash provided by financing activities		60,563			586
EFFECT OF EXCHANGE RATE CHANGES ON CASH		23			2

DECREASE IN CASH AND CASH EQUIVALENTS		(45,365	)		(4,365	)

CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD		77,245			19,296
CASH AND CASH EQUIVALENTS AT END OF PERIOD	$	31,880		$	14,931

(A) SUPPLEMENTARY DISCLOSURE ON CASH FLOWS -
Interest received	$	112		$	92
(B) SUPPLEMENTAL DISCLOSURE OF NON-CASH ACTIVITIES:
Recognition of operating lease right of use assets and liabilities	$	-		$	582

The accompanying notes are an integral part of the condensed consolidated financial statements.

ORAMED PHARMACEUTICALS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

U.S. Dollars in thousands (except share and per share data)

(UNAUDITED)

NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES:

General:

Incorporation and operations

Oramed Pharmaceuticals Inc. (collectively with its ~~subsidiary,~~subsidiaries, the “Company”, unless the context indicates otherwise) was incorporated on April 12, 2002, under the laws of the State of Nevada. From incorporation until March 3, 2006, the Company was an exploration stage company engaged in the acquisition and exploration of mineral properties. On February 17, 2006, the Company entered into an agreement with Hadasit Medical Services and Development Ltd. ~~(“Hadasit”)~~ to acquire the provisional patent related to an orally ingestible insulin capsule to be used for the treatment of individuals with diabetes.

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

On March 11, 2011, the Company was reincorporated from the State of Nevada to the State of Delaware.

On July 30, 2019, the Subsidiary incorporated a wholly-owned subsidiary in Hong Kong, Oramed HK Limited (the “Hong Kong Subsidiary”). As of November 30, 2021, the Hong Kong Subsidiary has no operations.

On November 30, 2015, the Company entered into a Technology License Agreement (the “TLA”), with Hefei Tianhui ~~Incubation~~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 ~~“License~~“HTIT License Agreement”). According to the 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 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%.See note 2b.

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 License Agreement shall remain in effect until the expiration of the Royalty Term. The License Agreement contains customary termination provisions.~~

~~ORAMED PHARMACEUTICALS INC.~~

~~NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS~~

~~U.S. Dollars in thousands (except share and per share data)~~

~~(UNAUDITED)~~

~~NOTE 1 - SIGNIFICANT ACCOUNTING POLICIES~~~~(continued):~~

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.

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 and the fourth milestone payment of $4,000 was received in October 2016.

~~In addition, on November 30, 2015,~~On March 18, 2021, the Company entered into a ~~Stock Purchase~~license agreement (the “Oravax License Agreement”) and into the Stockholders Agreement (as defined below) with ~~HTIT (the “SPA”~~Oravax Medical Inc. (“Oravax”). According to the ~~SPA,~~Stockholders Agreement, Oravax issued 1,890,000 shares of its capital stock to the Company, ~~issued 1,155,367 shares of common stock to HTIT for $12,000. The transaction closed on December 28, 2015.~~

The License Agreement and the SPA were considered a single arrangement with multiple deliverables. The Company allocated the total consideration of $49,500 between the License Agreement and the SPA according to their fair value, as follows: $10,617 was allocated to the issuance of common stock (less issuance expenses of $23), based on the quoted pricerepresenting 63% of the ~~Company’s shares~~issued and outstanding share capital of Oravax, on a fully diluted basis, as of the ~~closing~~ date of the SPA on December 28, 2015, and $38,883 was allocated to the License Agreement. Given the Company’s continuing involvement through the expected product submission (June 2023), amounts received relating to the License Agreement are recognized over the period from which the Companyissuance. Consequently, Oramed is ~~entitled to the respective payment, and the expected product submission date using a time-based model approach over the periods that the fees are earned.~~

In July 2015, according to the letter of intent signed between the parties or their affiliates, HTIT’s affiliate paid the Subsidiary a non-refundable amount of $500 as a no-shop fee. The no-shop fee was deferred and the related revenue is recognized over the estimated term of the License Agreement.

~~Amounts that were allocated to the License Agreement~~consolidating Oravax in its consolidated financial statements as of November 30, 2017 aggregated $19,383, all of which were received through the balance sheet date. Through November 30, 2017, the Company recognized revenue in the amount of $3,708, and deferred the remaining amount of $15,675.May 31, 2021.

72)

~~The following table summarizes the movement in deferred revenues balances for the three-month period ended November 30, 2017 and the year ended August 31, 2017:~~

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. ~~Continued operation of~~Based on the Company’s current cash resources and commitments, the Company ~~is contingent upon obtaining sufficient funding until~~believes it ~~becomes profitable.~~will be able to maintain its current planned development activities and the corresponding level of expenditures for at least the next 12 months, although no assurance can be given that the Company will not need additional funds prior to such time. If there are unexpected increases in its operating expenses, the Company may need to seek additional financing during the next 12 months. Successful completion of the Company’s development programs and its transition to normal operations is dependent upon obtaining necessary regulatory approvals from the U.S. Food and Drug Administration prior to selling its products within the United States, obtaining foreign regulatory approvals to sell its products internationally, or entering into licensing agreements with third parties. There can be no assurance that the Company will receive regulatory approval of any of its product candidates, and a substantial amount of time may pass before the Company achieves a level of revenues adequate to support its operations, if at all. The Company also expects to incur substantial expenditures in connection with the regulatory approval process for each of its product candidates during their respective developmental periods. Obtaining marketing approval will be directly dependent on the Company’s ability to implement the necessary regulatory steps required to obtain marketing approval in the United States and in other countries. The Company cannot predict the outcome of these activities.

In addition to the foregoing, based on the Company’s current assessment, the Company does not expect any material impact on its development timeline and its liquidity due to the worldwide spread of the COVID-19 virus. However, the Company is continuing to assess the effect on its operation by monitoring the spread of COVID-19 and the actions implemented by the governments to combat the virus throughout the world.

Basic and diluted net loss per common share are computed by dividing the net loss for the period by the weighted average number of shares of common stock outstanding for each period. Outstanding stock options, warrants and restricted stock units (“RSUs”) have been excluded from the calculation of the diluted loss per share because all such securities are anti-dilutive for all periods presented. The ~~total~~weighted average number of common stock options, warrants and RSUs excluded from the calculation of diluted net loss was ~~1,424,029~~3,138,733 and ~~2,470,494~~5,278,347 for the ~~three-month~~three month periods ended November 30, ~~2017~~2021 and ~~2016,~~November 30, 2020, respectively.

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.

Amounts that were allocated to the HTIT License Agreement as of November 30, 2021 aggregated $22,382, all of which were received through the balance sheet date. Through November 30, 2021, the Company has recognized revenue associated with this agreement in the aggregate amount of $16,109, of which $674 was recognized in the quarter ended November 30, 2021, and deferred the remaining amount of $6,273 which is presented as deferred revenues on the condensed consolidated balance sheet.

The condensed consolidated financial statements included herein have been prepared in accordance with United States generally accepted accounting principles (“U.S. ~~GAAP~~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, ~~2017~~2021 (the ~~“2017~~“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 ~~2017~~2021 Form 10-K. The results for interim periods are not necessarily indicative of a full fiscal year’s results.

In ~~May 2014,~~June 2016, the Financial Accounting Standards Board ~~(“FASB”)~~ issued Accounting Standards Update ~~(“ASU”) No. 2014-09 (Topic 606) “Revenue from Contracts~~2016-13 “Financial Instruments—Credit Losses—Measurement of Credit Losses on Financial Instruments.” This guidance replaces the current incurred loss impairment methodology with ~~Customers”~~a methodology that ~~will supersede most current revenue recognition guidance, including industry-specific guidance. The underlying principle~~reflects expected credit losses and requires consideration of ~~this ASU is that an entity will recognize revenue upon the transfer~~a broader range of ~~goods or services~~reasonable and supportable information to ~~customers in an amount that the entity expects to be entitled to in exchange for those goods or services.~~inform credit loss estimates. The guidance ~~provides a five-step analysis of transactions to determine when and how revenue is recognized. Other major provisions include capitalization of certain contract costs, consideration of~~will be effective for the time value of money in the transaction price, and allowing estimates of variable consideration to be recognized before contingencies are resolved in certain circumstances. The guidance also requires enhanced disclosures regarding the nature, amount, timing and uncertainty of revenue and cash flows arising from an entity’s contracts with customers. The guidance is effective in annual reporting periodsfiscal year beginning after December 15, ~~2017,~~2022, including interim ~~reporting~~ periods within that ~~reporting period.~~year. The ~~Company will implement~~adoption of this guidance is not expected to have a significant impact on the ~~guidance for the annual period ending on August 31, 2019. The Company is currently evaluating the impact of the guidance on its~~Company’s consolidated financial statements.

As part of this agreement, the Subsidiary entered into a patent transfer agreement (the “Patent Transfer Agreement”) according to which the Subsidiary assigned to Entera all of its right, title and interest in and to ~~the~~a certain patent application related to the oral administration of proteins that it has licensed to Entera since August 2010. Under this agreement, the Subsidiary is entitled to receive from Entera royalties of 3% of Entera’s net revenues (as defined in the agreement) and a license back of that patent application for use in respect of diabetes and influenza. As of November 30, ~~2017,~~2021, Entera ~~had not yet realized any revenues and~~ had not paid any royalties to the Subsidiary. On December 11, 2018, Entera announced that it had entered into a research collaboration and license agreement (the “Amgen License”) with Amgen related to the research of inflammatory disease and other serious illnesses. As reported by Entera, under the terms of the Amgen License, Entera will receive a modest initial technology access fee from Amgen and will be responsible for preclinical development at Amgen’s expense. Entera will be eligible to receive up to $270,000 in aggregate payments, as well as tiered royalties up to mid-single digits, upon achievement of various clinical and commercial milestones if Amgen decides to move all of these programs forward. Amgen is responsible for clinical development, manufacturing and commercialization of any of the resulting programs. To the extent the Amgen License results in net revenues as defined in the Patent Transfer Agreement, the Subsidiary will be entitled to the aforementioned royalties.

In addition, as part of a consulting agreement with a third party, dated February 15, 2011, the Subsidiary is obliged to pay this third party royalties of 8% of the net royalties received in respect of the patent that was sold to Entera in March 2011.

The annual lease payment is New Israeli Shekel (“NIS”) 119,000 ($34) from October 2016 through September 2018 and NIS 132,000 ($38) from October 2018 through September 2021, and is linked to the increase in the Israeli consumer price index (“CPI”) (as of November 30, 2017, the future lease payments until the expiration of the lease agreement will be $142, based on the exchange rate as of November 30, 2017).

~~As security for its obligation under this lease agreement, the Company provided a bank guarantee~~

U.S. Dollars in ~~an amount equal to three monthly lease payments.~~thousands (except share and per share data)

The Subsidiary is committed to pay royalties to Bio-Jerusalem on proceeds from future sales at a rate of 4% and up to 100% of the amount of the grant received (Israeli CPI linked) at the total amount of $65. The Company received no grants from Bio-Jerusalem since fiscal year 2013.

Through November 30, 2017, total milestone payments received which are related to the funded project aggregated $17,500 and all related royalty expenses were recognized in cost of revenues in prior periods.

Under the terms of the Company’s funding from the IIA, royalties of ~~3.5%~~3% are payable on sales of products developed from a project so funded, up to a maximum amount equaling 100%-150% of the grants received (dollar linked) with the addition of interest at an annual rate based on LIBOR.

At the time the grants were received, successful development of the related projects was not assured.

The total amount that was received through November 30, ~~2017~~2021 was ~~$2,194.~~$2,207 ($2,510 including interest).

~~Through~~As of November 30, ~~2017, total milestone payments received~~2021, the liability to the IIA was $207.

The royalty expenses which are related to the funded project ~~aggregated $17,500. The royalty expenses~~ were recognized in cost of revenues in ~~prior periods and will be paid over~~ the ~~term of the License Agreement in accordance with the revenue recognized from the related project.~~relevant periods.

The Company measures fair value and discloses fair value measurements for financial ~~assets and liabilities.~~assets. 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:

As of November 30, ~~2017,~~2021, the assets ~~or liabilities~~ measured at fair value are comprised of ~~available for sale~~ equity securities (Level 1).

~~In determining fair value, the Company utilizes valuation techniques that maximize the use of observable inputs and minimize the use of unobservable inputs to the extent possible.~~

As of November 30, 2017, the carrying amount of cash and cash equivalents, short-term deposits and other current assets, accounts payable and accrued expenses approximate their fair values due to the short-term maturities of these instruments.

~~As of November 30, 2017, the carrying amount of long-term deposits approximates their fair values due to the stated interest rates which approximate market rates.~~

The fair value of held to maturity bonds as presented in note 4 was based on a Level 12 measurement.

As of November 30, 2021, the carrying amounts of cash equivalents, short-term deposits and accounts payable approximate their fair values due to the short-term maturities of these instruments.

As of November 30, 2021, the carrying amounts of long-term deposits approximate their fair values due to the stated interest rates which approximate market rates.

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

There were no Level 3 items for the ~~three-month~~three month periods ended November 30, ~~2017~~2021 and ~~2016.~~November 30, 2020.

The Company’s marketable securities include investments in equity securities of D.N.A and Entera and in held to maturity bonds.

The investment in D.N.A is reported at fair value, with unrealized gains and losses, recorded as a separate component of other comprehensive income in equity until realized. Unrealized losses that are considered to be other-than-temporary are charged to statement of operations as an impairment charge and are included in the consolidated statement of operations under impairment of available-for-sale securities.

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

As of November 30, ~~2017,~~2021, the Company owns approximately ~~6.9%~~1.7% of D.N.A’s outstanding ordinary shares.

The cost of the securities as of November 30, ~~2017~~2021 and August 31, ~~2017~~2021 is $595.

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)).

The amortized cost and estimated fair value of held-to-maturity securities as of November 30, ~~2017,~~2021, are as follows:

As of November 30, 2017, the contractual maturities of debt securities classified as held-to-maturity are as follows: after one year through two years, $4,598, and the yield to maturity rates vary between 1.40% to 1.90%.

The amortized cost and estimated fair value of held-to-maturity securities as of August 31, ~~2017,~~2021, are as follows:

As of August 31, 2017, the contractual maturities of debt securities classified as held-to-maturity are as follows: after one year through two years, $2,151 and the yield to maturity rates vary between 1.30% to 1.87%.

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.

~~On April 2, 2015, the Company entered into an At~~ The Market Issuance Sales Agreement (the “Sales Agreement”) with B. Riley FBR, Inc., as successor to FBR Capital Markets & Co. (“FBR”), as amended, pursuant to which the Company may, from time to time and at its option, issue and sell shares of its common stock having an aggregate offering price of up to $25,000 through FBR as its sales agent, subject to certain terms and conditions. Any shares sold will be sold pursuant to the Company’s effective shelf registration statement on Form S-3 including a prospectus dated February 2, 2017, as supplemented by a prospectus supplement dated April 5, 2017. The Company will pay FBR a commission of 3.0%total value of the ~~gross proceeds of~~RSUs is $662, using the ~~sale of any shares sold through FBR. As of November 30, 2017, 456,889 shares were sold under the Sales Agreement~~Monte-Carlo model for ~~aggregate net proceeds of $4,256 and an additional 50,000 shares were subsequently sold during December 2017 for aggregate net proceeds of $441.~~RSUs with market conditions.

The right-of-use asset and lease liability are initially measured at the present value of the lease payments, discounted using the interest rate implicit in the lease or, if that rate cannot be readily determined, the Company’s incremental borrowing rate based on the information available at the date of adoption in determining the present value of the lease payments. The Company’s incremental borrowing rate is estimated to approximate the interest rate on similar terms and payments and in economic environments where the leased asset is located.

The Company has various operating leases for office space and vehicles that expire through 2025. Below is a summary of our operating right-of-use assets and operating lease liabilities as of November 30, 2021 and August 31. 2021:

On July 1, 2008, the Subsidiary entered into two consulting agreements with KNRY Ltd. (“KNRY”), an Israeli company owned by the ~~Chief Scientific Officer (the “CSO”),~~CSO, whereby the ~~Chief Executive Officer (the “CEO”)~~CEO and the CSO, through KNRY, provide services to the Company (the “Consulting Agreements”). The Consulting Agreements are both terminable by either party upon 140 days prior written notice. The Consulting Agreements, as amended, provide that KNRY will be reimbursed for reasonable expenses incurred in connection with the performance of the Consulting Agreements and that the monthly consulting fee paid to the CEO and the CSO is NIS ~~127,570~~146,705 ($~~35)~~46) and NIS ~~80,454~~106,400 ($~~22)~~34), respectively.

In addition to the Consulting ~~Agreement,~~Agreements, based on a relocation cost analysis, ~~prepared by consulting company ORI - Organizational Resources International Ltd.,~~ the Company pays for certain direct costs, related taxes and expenses incurred in connection with the relocation of the CEO to ~~New York, up~~U.S. During the three months ended November 30, 2021, such relocation expenses totaled $67, compared to ~~an aggregate yearly amount of $332.~~$74 for the three months ended November 30, 2020.

ITEM 2 - MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the condensed consolidated financial statements and the related notes included elsewhere herein and in our consolidated financial statements, accompanying notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in our Annual Report (as defined below).

The statements contained in this Quarterly Report on Form 10-Q that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Words such as “expects,” “anticipates,” “intends,” “plans,” “planned expenditures,” “believes,” “seeks,” ~~“estimates”~~“estimates,” “considers” and similar expressions or variations of such words are intended to identify forward-looking statements, but are not deemed to represent an all-inclusive means of identifying forward-looking statements as denoted in this Quarterly Report on Form 10-Q. Additionally, statements concerning future matters are forward-looking statements. We remind readers that forward-looking statements are merely predictions and therefore inherently subject to uncertainties and other factors and involve known and unknown risks that could cause the actual results, performance, levels of activity, or our achievements, or industry results, to be materially different from any future results, performance, levels of activity, or our achievements, or industry results, expressed or implied by such forward-looking statements. Such forward-looking statements include, among other statements, statements regarding the following:

Although forward-looking statements in this Quarterly Report on Form 10-Q reflect the good faith judgment of our management, such statements can only be based on facts and factors currently known by us. Consequently, forward-looking statements are inherently subject to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or anticipated by the forward-looking statements. Factors that could cause or contribute to such differences in results and outcomes include, without limitation, those specifically addressed under the heading “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended August 31, ~~2017,~~2021, or our Annual Report, as filed with the Securities and Exchange Commission, or the SEC, on November ~~29, 2017,~~24, 2021, as well as those discussed elsewhere in our Annual Report ~~and this QuarterlyReport on Form 10-Q~~ and expressed from time to time in our other filings with the SEC. In addition, historic results of scientific research, clinical and preclinical trials do not guarantee that the conclusions of future research or trials would not suggest different conclusions. Also, historic results referred to in this Quarterly Report on Form 10-Q could be interpreted differently in light of additional research, clinical and preclinical trials results. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this Quarterly Report on Form 10-Q. Except as required by law, we undertake no obligation to revise or update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this Quarterly Report on Form 10-Q. Readers are urged to carefully review and consider the various disclosures made throughout the entirety of this Quarterly Report on Form 10-Q which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operations and prospects.

We are a pharmaceutical company currently engaged in the research and development of innovative pharmaceutical solutions, including an oral insulin capsule to be used for the treatment of individuals with diabetes, and the use of orally ingestible capsules or pills for delivery of other polypeptides. We utilize Clinical Research Organizations, or CROs, to conduct our clinical studies.

Through our research and development efforts, we have successfully developed an oral dosage form intended to withstand the harsh environment of the stomach and intestines and effectively deliver active insulin or other proteins, such as Glucagon-like peptide-1, or GLP-1, leptin, and others. The excipients in the formulation are not intended to modify the proteins chemically or biologically, and the dosage form is designed to be safe to ingest. We plan to continue to conduct clinical trials to show the effectiveness of our technology.

~~In August 2017, we had a call with the U.S. Food and Drug Administration, or FDA, regarding our~~: Our proprietary flagship product, an orally ingestible insulin capsule, or ~~ORMD-0801. During~~ORMD-0801, allows insulin to travel from the ~~call,~~gastrointestinal tract via the portal vein to the bloodstream, revolutionizing the manner in which insulin is delivered. It enables the passage in a more physiological manner than current delivery methods of insulin.

FDA ~~advised~~Guidance: In August 2017, the U.S. Food and Drug Administration, or FDA, instructed us that the regulatory pathway for the submission of ORMD-0801 would be a ~~Biologics License Application.~~BLA. If approved, ~~such a~~the BLA pathway would grant us 12 years of marketing exclusivity for ORMD-0801, from the approval date, and an additional six months of exclusivity may be granted to us if the product also receives approval for use in pediatric patients. The FDA confirmed that the approach to nonclinical toxicology, chemistry manufacturing controls and qualification of excipients would be driven by their published guidance documents. We plan to initiate in the first quarter of calendar year

Phase IIb Study: In May 2018, we initiated a three-month dose-ranging Phase IIb clinical trial of ORMD-0801 (Cohort A). This placebo controlled, randomized, 90-day treatment clinical trial was conducted on ~~approximately 240~~269 type 2 diabetic, or T2D, patients in multiple centers throughout the United States pursuant to an Investigational New Drug application, or IND, with the FDA. The primary endpoints of the trial were to assess the safety and evaluate the effect of ORMD-0801 on HbA1c ~~the main FDA registrational endpoint and~~levels over a ~~clamp study on six type 1 diabetic patients.~~

In February 2017, we completed a Phase IIa dose finding clinical trial which was initiated in October 2016. This randomized, double-blind trial was conducted on 32 type 2 adult diabetic patients in order to better define the optimal dosing of ORMD-0801 moving forward. The results90-day treatment period. Secondary endpoints of the trial ~~indicated~~included measurements of fasting plasma glucose, or FPG, post-prandial glucose, or PPG levels, during a mixed-meal tolerance test, or MMTT, and weight. In May 2019, we initiated an extension of this protocol for approximately 75 T2D patients, who were dosed using a lower dosage of insulin (Cohort B).

Cohort A: In November 2019, we announced positive results from the initial cohort of the Phase IIb trial. Patients randomized in the trial to once-daily ORMD-0801 achieved a statistically significant (p-value 0.036) reduction from baseline in HbA1c of 0.60% (0.54% with placebo adjustment). This 0.54% reduction in HbA1c is clinically meaningful. Treatment with ORMD-0801 demonstrated an excellent safety profile, with no serious drug-related adverse events and ~~potentially meaningful~~with no increased frequency of hypoglycemic episodes when compared to placebo. In addition, during this 90-day trial, no weight gain was observed. In the initial cohort, 269 U.S.-based patients were enrolled and treated with a dose-increasing approach: 16 mg initial dose, titrated to 24 mg per dose, and then titrated to 32 mg per dose. Patients were randomized into three groups to assess dosing frequency: once-daily (32 mg per day), twice-daily (64 mg per day), thrice daily (96 mg per day). There was a corresponding placebo for each treatment arm. Two hundred nine (209) patients completed treatment to the 12-week endpoint and were included in the data analysis (24 subjects did not complete the full 12 weeks of treatment). The twice-daily arms achieved statistically significant (p-value 0.042) reductions from baseline in HbA1c of 0.59% (0.53% with placebo adjustment). The thrice-daily arm did not meet statistical significance (p-value 0.093). In addition, due to evidence of treatment-by-center interaction, two sites (36 patients (13.4% of enrolled subjects)) were excluded from the statistical analysis as they showed results opposite from the rest of the statistically significant results. Our internal investigation as well as an independent investigation did not find a cause for such discrepancy.

Cohort B: In February 2020, we announced positive topline data from the second and final cohort of the Phase IIb trial with a different regimen across three daily dose ranges (8 mg, 16 mg, 32 mg). Patients randomized in the trial treated with 8 mg of ORMD-0801 once-daily achieved a statistically significant (p-value 0.028) observed mean reduction of 1.29% from baseline and a least square mean reduction of 0.95% from baseline, or 0.81% adjusted for placebo. Patients who had HbA1c readings above 9% at baseline and received 8 mg of oral insulin once-daily experienced a 1.26% reduction in HbA1c by week 12. Treatment with ORMD-0801 at all doses demonstrated an excellent safety profile, with no serious drug-related adverse events and with no increased frequency of hypoglycemic episodes or weight gain compared to placebo. The primary efficacy endpoint was a reduction in HbA1c at week 12.

Phase III Study: Based on guidance received from the FDA as part of the end-of-phase II meeting process for our oral insulin candidate, ORMD-0801, we have submitted to the FDA the protocols for our upcoming pivotal Phase III studies. In line with the FDA’s expectations and recommendations, we are currently conducting two Phase III studies concurrently in patients with T2D. These studies involve about 1,125 patients to provide evidence of ORMD-0801’s safety and efficacy in T2D patients over a treatment period of 6 to 12 months. A geographically diverse patient population is being recruited from multiple sites throughout the United States, Europe, and Israel. Our Phase III study is composed from 2 protocols:

ORA-D-013-1: This study will treat T2D patients with inadequate glycaemic control who are currently on 2 or 3 oral glucose-lowering agents. This U.S. study will recruit 675 patients from over 90 clinical sites located throughout the U.S. Patients will be randomized 1:1:1 in this double-dummy study into cohorts of: 8 mg ORMD-0801 once-daily at night and placebo 45 minutes before breakfast; 8 mg ORMD-0801 twice-daily, at night and 45 minutes before breakfast; and placebo twice-daily, at night and 45 minutes before breakfast. The primary endpoint of the study is to evaluate the efficacy of ORMD-0801 compared to placebo in improving glycaemic control as assessed by HbA1c, with a secondary efficacy endpoint of assessing the change from baseline in fasting plasma glucose at 26 weeks. We initiated this trial in December 2020. In November 2021, we announced that 75% of the 675 patients were enrolled and randomized.

ORA-D-013-2: This study will include T2D patients with inadequate glycaemic control who are managing their condition with either diet alone or with diet and metformin monotherapy. A total of 450 patients will be recruited through 36 sites in the U.S. and 25 sites in Western Europe and Israel. Patients will be randomized 1:1 into two cohorts dosed with: 8 mg ORMD-0801 at night; and placebo at night. The primary endpoint is to evaluate the efficacy of ORMD-0801 compared to placebo in improving glycaemic control as assessed by HbA1c over a 26-week treatment period, with a secondary efficacy endpoint of assessing the change from baseline in fasting plasma glucose at 26 weeks. We initiated this trial in the U.S. in March 2021. In August 2021, we announced that over 25% of the 450 patients were enrolled and randomized.

We expect to receive the efficacy data ~~suggest~~from the trials after patients have completed the first 6 months of treatment. Safety will be further monitored as patients will be exposed to the drug over an additional 6 months (total 12 months). The trial’s topline results are expected in calendar 2022 and we anticipate filing a BLA with the FDA in calendar 2024. A BLA would grant us 12 years of marketing exclusivity from the date of approval in the U.S.

NASH trial: In June 2020, we presented topline data of 8 patients from an open-label trial that assessed the safety, tolerability, and early effects of 16 mg ORMD-0801 ~~improves glucose control.~~

(2x8 mg capsules) on liver fat in T2D, patients with nonalcoholic steatohepatitis, or NASH. The 12-week dosing had no serious adverse events and it induced an observed mean 6.9±6.8% reduction in liver fat content (p-value: 0.035), and the relative reduction of 30%, as measured by MRI-derived proton density fat fraction, or MRI-PDFF. In ~~March 2017,~~parallel, concentrations of gamma-glutamyltransferase (GGT), a key marker of chronic hepatitis, were significantly lower after 12 weeks of treatment as compared to baseline (-14.6±13.1 U/L; p value: 0.008).

In September 2020, we initiated ~~a six month toxicology study to allow for the use~~an open label clinical trial of our oral insulin capsule, ORMD-0801, for the treatment of NASH. This 10 patient multi-center trial is comprised of three clinical sites in Belgium. The trial will measure change and percent change in MRI-PDFF from baseline to week 12.

In December 2020, we initiated a ~~longer period than previously performed, in preparation for our proposed upcoming three-month~~double blind, placebo controlled clinical trial of our oral insulin capsule, ORMD-0801, for ~~type 2 diabetes. We anticipate receiving~~ the ~~final report~~treatment of ~~this study~~NASH. This 30 patient multi-center trial is comprised of five clinical sites: three in the ~~first quarter~~U.S. and two in Israel. The trial will measure change and percent change in MRI-PDFF from baseline to week 12. In September 2021, we announced that over 50% of ~~calendar year 2018.~~the patients were enrolled and randomized.

Oral Glucagon-Like Peptide-1: Oral GLP-1, is an incretin hormone, which stimulates the secretion of insulin from the pancreas. In ~~April 2016,~~addition to our flagship product, the ORMD-0801 insulin capsule, we use our technology for an orally ingestible GLP-1 capsule, or ORMD-0901.

In February 2019, we completed a Phase ~~IIb clinical~~I pharmacokinetic trial on 180 type 2 adult diabetic patients that was initiated in June 2015 and conducted in 33 sites in the United States. This double-blind, randomized, 28-day dosing clinical trial was conducted under an Investigational New Drug application, or IND, with the FDA. The clinical trial, designed to ~~assess~~evaluate the safety and ~~efficacy~~pharmacokinetics of ~~our ORMD-0801, investigated ORMD-0801 over~~ORMD-0901 compared to placebo in healthy volunteers. We initiated a ~~28 day treatment period and had statistical power to give us greater insight into~~follow-on trial in T2D patients, in June 2021 in the drug’s efficacy. The trial indicated a statistically significant lowering of blood glucose levels versus placebo across several endpoints, with no serious or severe adverse issues related to the drug. The trial successfully met all of its primary and most of its secondary and exploratory endpoints for both safety and efficacy.

Should our Phase IIb three-month dose-ranging clinical trial successfully meet its primary endpoints, we anticipate initiating two six-month Phase III clinical trials on both type 1 and type 2 diabetic patients, following which we expect to file a New Drug Application with a potential FDA approval by the third quarter of calendar year 2023.

In September 2013, we submitted a pre-IND package to the FDA for ORMD-0901, our oral exenatide capsule, for a Phase II clinical trial on healthy volunteers and type 2 diabetic patients. In August 2015, we began a non-FDA clinical trial outside of the United States on type 2 diabetic patients. The trial was completed during the second quarter of calendar year 2016 and indicated positive results as it showed ORMD-0901 to be safe and well tolerated and demonstrated encouraging efficacy data. We completed a three-month pre-clinical toxicology study in March 2017 and the final report will beU.S. under an IND submitted to the ~~FDA~~FDA.

On March 18, 2021, we entered into a license agreement, or the Oravax License Agreement, with Oravax. For more information about the Oravax License Agreement, please see below under “Out-Licensed Technology”.

Oravax, Oramed’s 63% owned joint venture combines our ~~IND.~~proprietary POD™ oral delivery technology and the novel vaccine technology of Premas Biotech Pvt. Ltd., or Premas. We ~~expect~~are considering ways in which our shareholders could benefit more directly from Oravax, including potentially issuing some of our shares in Oravax to ~~file an IND during~~our shareholders as a dividend, which would make Oravax a publicly held company that may in turn apply for listing on a stock exchange.

A single dose of Oravax’s oral vaccine produced a significant antibody response in a preclinical in-vivo study. Oravax’s novel vaccine technology may be a candidate for protection against COVID-19 and its variants due to triple antigen targeting, easier distribution and ease of administration.

On October 29, 2021, we announced Oravax’s oral COVID-19 vaccine has received clearance from the South African Health Products Regulatory Authority to initiate a Phase I trial and subsequently to commence patient enrollment in a first in human, Phase 1 clinical trial, for its oral COVID-19 vaccine and on December 14, 2021, Oravax screened and enrolled the first ~~quarter~~participant in a Phase 1 clinical trial of ~~calendar year 2018~~its oral virus-like particle (VLP) COVID-19 vaccine in Johannesburg, South Africa.

On December 29, 2021, Oravax signed a cooperation and ~~move directly into a small pharmacokinetics study on healthy volunteers followed by a large Phase II trial on type 2 diabetic patients which will be conducted~~purchase agreement for an initial pre-purchase of 10 million doses of oral COVID-19 vaccines with Tan Thanh Holdings to commercialize the vaccine in ~~the United States under an IND.~~Southeast Asia.

~~During the first quarter of calendar 2017, we began~~We are developing a new drug candidate, a weight loss treatment in the form of an oral leptin ~~capsule, and in April 2017, Israel’s Ministry~~capsule. During the third quarter of ~~Health approved our commencement of~~the 2020 calendar year, we finalized a proof of concept ~~single dose study~~single-dose trial for ~~our oral leptin drug~~this candidate to evaluate its ~~pharmacokinetic~~pharmacokinetics and pharmacodynamics (glucagon reduction) in 10 type 1 adult diabetic ~~patients. The study is projected~~patients without any safety issues. Patients who received leptin on average had a decrease in glucose as compared to ~~initiate~~the placebo group during the first 30-180 minutes following dosing. At different time periods, the leptin treated patients on average had glucagon values that were either lower than or similar to, those in ~~calendar year 2018 and be completed during calendar year 2019.~~

~~In November 2017, Israel’s Ministry~~the placebo group. We are currently in the middle of ~~Health approved us to initiate an exploratory clinical~~a second study of ~~our oral insulin capsule, ORMD-0801,~~15 type 1 adult diabetic patients who serve as both the active and placebo arms in ~~patients~~this study, with ~~nonalcoholic steatohepatitis (NASH). The proposed three-month treatment study will assess~~anticipated results in the ~~effectiveness~~first quarter of ~~ORMD-0801 in reducing liver fat content, inflammation and fibrosis in patients with NASH. We expect to initiate~~ the ~~study in~~2022 calendar ~~year 2018 and complete it during calendar year 2019.~~year.

~~The table below gives an overview of our primary product pipeline (calendar quarters):~~

On November 30, 2015, we, ~~our Israeli subsidiary~~Oramed Ltd. and HTIT entered into a Technology License Agreement, or TLA, and on December 21, 2015, these 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, or the HTIT License Agreement. According to the HTIT License Agreement, we granted HTIT an exclusive commercialization license in the territory of the People’s Republic of China, Macau and Hong Kong ~~or the Territory,~~(the “Territory”), related to our oral insulin capsule, ORMD-0801, or the Product. Pursuant to the HTIT License Agreement, HTIT will conduct, at its own expense, certain pre-commercialization and regulatory activities with respect to our subsidiary’s technology and ORMD-0801 capsule, and will pay (i) royalties of 10% on net sales of the related commercialized products to be sold by HTIT in the Territory, or Royalties, and (ii) an aggregate of $37.5 million, of which $3 million iswas payable immediately, $8 million will be paid subject to our entry into certain agreements with certain third parties, and $26.5 million will be payable upon achievement of certain milestones and conditions. In the event that we will not meet certain conditions, the Royalties rate may be reduced to a minimum of 8%. Following the final expiration of our 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 ~~final~~ expiration of the last-to-expire licensed ~~patent~~patents in the ~~Territory~~Territory; and (ii) 15 years after the first commercial sale of the Product in the Territory, or 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. ~~The initial payment of $3 million was~~Through November 30, 2021, we received ~~in January 2016. Following the achievement of certain milestones, the second and third~~aggregate milestone payments of ~~$6.5~~$20.5 million out of the aggregate amount of $37.5 million.

On August 21, 2020, we received a letter from HTIT, disputing certain pending payment obligations of HTIT under the TLA. We wholly dispute said claims and ~~$4 million, respectively, were received~~we are in ~~July 2016, and the fourth milestone payment of $4 million was received~~discussions with HTIT in ~~October 2016.~~an attempt to reach a mutually agreeable solution.

On ~~November 30, 2015,~~March 18, 2021, we ~~also~~ entered into ~~a separate Securities Purchase~~the Oravax License Agreement with ~~HTIT, or the SPA,~~Oravax, pursuant to which we will grant to Oravax an exclusive, worldwide license, or the License, under our rights in ~~December 2015,~~certain patents and related intellectual property in which Oravax will receive certain rights relating to our proprietary oral delivery technology to further develop, manufacture and commercialize oral vaccines for COVID-19 and other novel coronaviruses based on Premas’s proprietary vaccine technology involving a triple antigen virus like particle, or the Oravax Product, which was previously owned by Cystron Biotech LLC, or Cystron, and later acquired by Akers Biosciences Inc., or Akers.

In consideration for the grant of the License, the Oravax License Agreement provides that we ~~issued~~will receive (i) royalties equal to ~~HTIT 1,155,367~~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 million to $100 million, 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 us, that will oversee the ongoing research, development, clinical and regulatory activity with respect to the Oravax Product. In addition, we agreed to buy and Oravax agreed to issue to us 1,890,000 shares of ~~our~~ common stock of Oravax, representing 63% of the common stock of Oravax for ~~total consideration~~the aggregate amount of ~~$12~~$1.5 million. ~~In connection with~~Akers agreed to contribute to Oravax $1.5 million in cash and substantially all of the ~~License Agreement~~assets of Cystron, including a license agreement to Premas’s novel vaccine technology. Nadav Kidron, the Company’s President and Chief Executive Officer, was one of the ~~SPA, we received a non-refundable payment~~former members of ~~$500,000 as a no-shop fee.~~Cystron.

Comparison of three month periods ended November 30, ~~2017~~2021 and ~~2016~~November 30, 2020

The following table summarizes certain statements of operations data of the Company for the three month periods ended November 30, ~~2017~~2021 and ~~2016~~November 30, 2020 (in thousands of dollars except share and per share data):

Revenues consist of proceeds related to the HTIT License Agreement that are recognized ~~over~~on a cumulative basis when it is probable that a significant reversal in the ~~term~~amount of cumulative revenue recognized will not occur, through the ~~License Agreement through~~expected product submission date of June ~~2023.~~2023 using the input method.

Revenues were $674,000 for each of the three month ~~period~~periods ended November 30, ~~2017 totaled $611,000, consistent with $610,000 for the three month period ended~~2021 and November 30, ~~2016.~~2020.

Cost of revenues consists of royalties related to the HTIT License Agreement that will be paid over the term of the HTIT License Agreement in accordance with revenue recognition accounting and the Law for the Encouragement of Industrial Research, Development and Technological Innovation, 1984, as amended, including any regulations or tracks promulgated thereunder.

NoThere was no cost of revenues ~~was recognized during the three month period ended November 30, 2017 compared to cost of revenues of $187,000~~ for the three month ~~period~~periods ended November 30, ~~2016. The decrease is due to no additional milestone payments having been received during the three month period ended~~2021 and November 30, ~~2017.~~2020.

Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, employee benefits, costs of materials, supplies, the cost of services provided by outside contractors, including services related to our clinical trials, clinical trial expenses, the full cost of manufacturing drugs for use in research and preclinical development. All costs associated with research and development are expensed as incurred.

Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. We outsource a substantial portion of our clinical trial activities, utilizing external entities such as ~~contract research organizations, or~~ CROs, independent clinical investigators and other third-party service providers to assist us with the execution of our clinical studies.

Clinical activities, which relate principally to clinical sites and other administrative functions to manage our clinical trials, are performed primarily by CROs. CROs typically perform most of the start-up activities for our trials, including document preparation, site identification, screening and preparation, pre-study visits, training, and program management.

Clinical trial and pre-clinical trial expenses include regulatory and scientific consultants’ compensation and fees, research expenses, purchase of materials, cost of capsule manufacturing, ~~of the oral insulin and exenatide capsules,~~ payments for patient recruitment and treatment, as well as salaries and related expenses of research and development staff.

Research and development expenses for the three month period ended November 30, ~~2017 decreased~~2021 increased by 1%11% to ~~$2,327,000,~~$6,410,000, from ~~$2,353,000~~$5,774,000 for the three month period ended November 30, ~~2016.~~2020. The ~~decrease~~increase is ~~mainly~~primarily due to ~~completion of our dose finding clinical trial and is partially offset by~~ an increase in expenses related to ~~progress in toxicology studies and preparations for~~ our Phase ~~IIb three-month~~3 and NASH clinical ~~trial.~~trials in addition to expenses related to the in process research and development costs related to Oravax. Stock-based compensation costs for the three month period ended November 30, ~~2017~~2021 totaled ~~$171,000,~~$505,000, as compared to ~~$136,000~~$137,000 during the three month period ended November 30, ~~2016.~~2020. The increase is mainly attributable to awards granted to ~~employees and~~ a consultant ~~during~~and to new award grants in fiscal ~~year 2017.~~2021.

In the three month periods ended November 30, ~~2017~~2021 and ~~2016,~~November 30, 2020, we did not recognize any research and development grants. As of November 30, ~~2017,~~2021, we incurred liabilities to pay royalties to the Israel Innovation Authority of the Israeli Ministry of Economy & Industry of ~~$533,000.~~$207,000.

Sales and Marketing expenses include the salaries and related expenses of our commercial functions, consulting costs and other general costs. We anticipate that our commercial activities will increase in the future towards and following potential approval of our planned BLA submission for ORMD-0801.

Sales and Marketing expenses for the three month period ended November 30, 2021 were $585,000 while we incurred no expenses for the three month period ended November 30, 2020. The increase in costs related to sales and marketing expenses activities is primarily attributable to stock-based compensation expenses and salary related expenses. Stock-based compensation costs for the three month period ended November 30, 2021 totaled $433,000 while there were no stock-based compensation expenses during the three month period ended November 30, 2020. The increase is mainly attributable to awards granted to an employee during fiscal 2021.

General and administrative expenses include the salaries and related expenses of our management, consulting costs, legal and professional fees, travel expenses, business development costs, insurance expenses and other general costs.

General and administrative expenses for the three month period ended November 30, ~~2017~~2021 increased by ~~117%~~139% to ~~$1,016,000~~$1,739,000 from ~~$468,000~~$727,000 for the three month period ended November 30, ~~2016.~~2020. The increase in costs related to general and administrative activities ~~during the three month period ended November 30, 2017~~ is ~~mainly~~primarily attributable to an increase in stock-based compensation ~~costs, consulting~~expenses and ~~travel~~professional fees expenses ~~related to the relocation of our Chief Executive Officer to New York, where the Company has leased an office since September 2017.~~as well as public relations and investor relations expenses. Stock-based compensation costs for the three month period ended November 30, ~~2017~~2021 totaled ~~$352,000,~~$772,000, as compared to ~~$23,000~~$180,000 during the three month period ended November 30, ~~2016.~~2020. The increase is mainly attributable to awards granted to ~~employees~~an employee during the three month period ended November 30, 2021 and ~~a consultant~~to awards granted during fiscal ~~year 2017.~~2021.

Net financial income ~~increased by 24%~~decreased from net financial income of ~~$162,000~~$257,000 for the three month period ended November 30, ~~2016~~2020 to net ~~income~~financial expenses of ~~$201,000~~$38,000 for the three month period ended November 30, ~~2017. The increase is mainly attributable to an increase in income from bank deposits and held to maturity bonds as a result of an increase in interest rates.~~

~~No taxes on income were recognized for the three month period ended November 30, 2017 as compared to $400,000 for the three month period ended November 30, 2016.~~2021. The decrease is ~~due~~primarily attributable to a decrease in withholding tax deducted from milestone payments received related to the License Agreement that resulted from a decrease in such proceeds. The Company estimates that withholding tax will not be utilized in the next five years, and therefore it was deducted.

Unrealized gains on available for sale securities for the three month period ended November 30, 2017 of $326,000, compared to losses of $63,000 for the three month period ended November 30, 2016, resulted from the increase in fair value of the ordinary shares of ~~D.N.A Biomedical Solutions~~Entera Bio Ltd. ~~that we hold.~~

From inception through November 30, ~~2017,~~2021, we have incurred losses in an aggregate amount of ~~$59,027,000.~~$122,742,000. During that period and through January 11, 2022, we have financed our operations through several private placements of our common stock, as well as public offerings of our common stock, raising a total of ~~$60,309,000,~~$241,432,000, net of transaction costs. During that period, we also received cash consideration of ~~$5,810,000~~$27,922,000 from the exercise of warrants and options. We ~~will~~expect to seek to obtain additional financing through similar sources in the future, as needed. As of November 30, ~~2017,~~2021, we had ~~$1,258,000~~$31,880,000 of available cash, ~~$32,772,000~~$136,156,000 of short-term and long-term bank deposits and ~~$7,320,000~~$11,704,000 of marketable securities.

Management continues to evaluate various financing alternatives for funding future research and development activities and general and administrative expenses through fundraising in the public or private equity markets. Although there is no assurance that we will be successful with those initiatives, management believes that it will be able to secure the necessary financing as a result of future third party investments. Based on our current cash resources and commitments, we believe we will be able to maintain our current planned development activities and the corresponding level of expenditures for at least the next 12 ~~months and beyond.~~months.

As of November 30, ~~2017,~~2021, our total current assets were ~~$19,135,000~~$152,332,000 and our total current liabilities were ~~$5,124,000.~~$7,660,000. On November 30, ~~2017,~~2021, we had a working capital surplus of ~~$14,011,000~~$144,672,000 and an accumulated loss of ~~$59,027,000.~~$122,742,000. As of August 31, ~~2017,~~2021, our total current assets were ~~$20,297,000~~$95,337,000 and our total current liabilities were ~~$5,165,000.~~$6,679,000. On August 31, ~~2017,~~2021, we had a working capital surplus of ~~$15,132,000~~$88,658,000 and an accumulated loss of ~~$56,496,000.~~$114,852,000. The ~~decrease~~increase in working capital from August 31, ~~2017~~2021 to November 30, ~~2017~~2021 was primarily due to ~~investment in long-term deposits and marketable securities.~~capital raising.

During the three month period ended November 30, ~~2017,~~2021, cash and cash equivalents decreased to ~~$1,258,000~~$31,880,000 from the ~~$3,969,000~~$77,245,000 reported as of August 31, ~~2017,~~2021, which is due to the reasons described below.

Operating activities used cash of ~~$2,728,000~~$6,903,000 in the three month period ended November 30, ~~2017,~~2021, as compared to ~~$1,498,000 provided~~$6,152,000 used in the three month period ended November 30, ~~2016.~~2020. Cash used in operating activities ~~in the three month period ended November 30, 2017~~ primarily consisted of net loss resulting from research and development, sales and marketing and general and administrative expenses, as well as changes in deferred ~~revenues~~revenue due to the HTIT License Agreement and is partially offset by changes in accounts payable and accrued expenses and stock-based ~~compensation, while~~compensation.

Investing activities used cash of $99,048,000 in the three month period ended November 30, 2021, as compared to cash provided by ~~operating~~investing activities of $1,199,000 in the three month period ended November 30, 2020. Cash used in investing activities in the three month period ended November 30, ~~2016~~2021 consisted primarily ~~consisted~~ of ~~changes in deferred revenues and is partially offset~~the purchase of short-term deposits. Cash provided by ~~net loss resulting from research and development and general and administrative expenses.~~

~~Investing~~investing activities ~~used cash of $5,146,000~~ in the three month period ended November 30, ~~2017, as compared~~2020 consisted primarily of the proceeds from the sale of short-term deposits and held to ~~$3,436,000 used~~maturity securities and mutual funds and is partially offset by the purchase of short term deposits and the purchase of held to maturity securities and corporate bonds designated at fair value.

Financing activities provided cash of $60,563,000 in the three month period ended November 30, 2016. Cash used in investing activities in the three month periods ended November 30, 2017 and 2016 consisted primarily of the purchase of short-term and long-term bank deposits and marketable securities.

~~Financing activities provided cash of $5,160,000 in the three month period ended November 30, 2017,~~2021, as compared to ~~$320,000 that were~~$586,000 provided in the three month period ended November 30, ~~2016. Financing~~2020. Cash provided by financing activities inconsisted primarily proceeds from the ~~three month period ended November 30, 2017 consisted of aggregate net proceeds of $4,230,000 from our~~ issuance of ~~453,919~~our common stock ~~under an At The Market Issuance Sales Agreement, dated April 2, 2015, or the Sales Agreement, with B. Riley FBR, Inc.,~~ as ~~successor to FBR Capital Markets & Co., or FBR,~~well as ~~amended, and proceeds from exercise of warrants and options while financing activities in the three month period ended November 30, 2016 consisted of~~ proceeds from the exercise of ~~options. Pursuant~~options and warrants.

On September 1, 2021, we entered into a controlled equity offering agreement, or the Cantor Equity Distribution Agreement, with Cantor Fitzgerald & Co., as agent, pursuant to which the ~~Sales Agreement, we~~Company may ~~from time to time and at our option,~~ issue and sell shares of ~~our~~its common stock having an aggregate offering price of up to ~~$25,000,000~~$100,000,000, through ~~FBR as~~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 ~~February 2, 2017, as supplemented by a~~July 26, 2021 and prospectus supplement dated ~~April 5, 2017.~~September 1, 2021. We ~~will pay FBR~~paid the sales agent a cash commission of 3.0% of the gross proceeds of the sale of any shares sold through ~~FBR.~~the sales agent under the Cantor Equity Sales Agreement. As of January 11, 2022, 565,120 shares were issued under the Cantor Equity Distribution Agreement for aggregate net proceeds of $12,298,000.

On November 3, 2021, we entered into a securities purchase agreement with several institutional and accredited investors, or the Purchasers, pursuant to which we agreed to sell, in a registered direct offering, or the Offering, an aggregate of 2,000,000 shares of our 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 us from the Offering, after deducting the placement agent’s fees and expenses and the Company’s Offering expenses, were approximately $46,375,000.

~~Off-balance sheet arrangements~~Critical accounting policies and estimates

As of November 30, 2017, we had no off-balance sheet arrangements that have had or that we expect would be reasonably likely to have a future material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

Our ~~significant~~critical accounting policies are described in ~~the notes to the consolidated financial statements as~~“Management’s Discussion and Analysis of ~~August 31, 2017 included~~Financial Condition and Results of Operations” contained in our Annual Report.

We invest heavily in research and development, and we expect that in the upcoming years our research and development expenses will continue to be our major operating expense.

There has been no significant change in our exposure to market risk during the ~~three month period~~quarter ended November 30, ~~2017.~~2021. For a discussion of our exposure to market risk, refer to Part II, Item 7A, “Quantitative and Qualitative Disclosures About Market Risk,” contained in our Annual Report.

Our management, including our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of November 30, ~~2017.~~2021. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures are effective.

There were no changes in our internal control over financial reporting that occurred during the quarter ended November 30, ~~2017~~2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

On November 1, 2017, we issued 2,500 shares of our common stock to Corporate Profile, LLC, or Corporate Profile, in payment of a portion of the consulting fee for investor relations services owed to Corporate Profile pursuant to a Stock Purchase Agreement and Letter Agreement, each dated May 3, 2017, between us and Corporate Profile.

On October 24, 2017, we issued 8,750 shares of our common stock to an investor resulting from his exercise of warrants purchased in connection with our 2012 private placement for a total exercise price of $52,500.

On November 14, 2017, we issued 6,399 shares of our common stock to an investor resulting from his exercise of warrants purchased in connection with our 2012 private placement for a total exercise price of $38,394.

~~We issued these shares pursuant to an exemption from registration contained in Section 4(a)(2) of the Securities Act of 1933, as amended.~~

	Three months ended November 30,			Year ended August 31,
	2017			2017

Deferred revenue at the beginning of period	$	16,286		$	14,766
Amounts received		-			4,000
Amounts due to the Company		-			(24	)
Revenue recognized		(611	)		(2,456	)
Deferred revenue at the end of period		15,675			16,286
Less – current deferred revenue portion		(2,449	)		(2,449	)
Non-current deferred revenue portion	$	13,226		$	13,837

	November 30, 2017		August 31, 2017
Short-term:
D.N.A (see b below)	$	1,322	$	996
Held to maturity bonds (see c below)		1,400		1,864
	$	2,722	$	2,860
Long-term:
Held to maturity bonds (see c below)	$	4,598	$	2,151

	November 30, 2021		August 31, 2021
Short-term:
D.N.A (see b below)	$	724	$	701
Entera (see c below)		397		571
Held to maturity bonds (see d below)		6,452		4,579
	$	7,573	$	5,851
Long-term:
Held to maturity bonds (see d below)	$	4,131	$	6,692
	$	11,704	$	12,543

	November 30, 2017
	Amortized cost		Gross unrealized losses			Estimated fair value
Short-term:
Commercial bonds	$	1,359	$	(2	)	$	1,357
Accrued interest		41		-			41

Long-term		4,598		(27	)		4,571
	$	5,998	$	(29	)	$	5,969

	November 30, 2021
	Amortized cost		Gross unrealized gains (losses)			Estimated fair value		Average yield to maturity rate
Short-term:
Commercial bonds	$	6,348	$	(109	)	$	6,239		1.42	%
Accrued interest		104		-			104

Long-term		4,131		(20	)		4,111		1.24	%
	$	10,583	$	(129	)	$	10,454

							Accumulated
					Additional		other					Total
	Common Stock				paid-in		comprehensive		Accumulated			stockholders’
	Shares		$		capital		income		loss			equity
	In thousands
BALANCE AS OF AUGUST 31, 2017		13,668	$	163	$	75,170	$	401	$	(56,496	)	$	19,238
CHANGES DURING THE THREE-MONTH PERIOD ENDED NOVEMBER 30, 2017:
SHARES ISSUED FOR SERVICES		3		*		24		-		-			24
ISSUANCE OF COMMON STOCK, NET		454		5		4,225		-		-			4,230
EXERCISE OF WARRANTS AND OPTIONS		178		2		928		-		-			930
STOCK-BASED COMPENSATION		5		*		524		-		-			524
NET LOSS		-		-		-		-		(2,531	)		(2,531	)
OTHER COMPREHENSIVE INCOME		-		-		-		326		-			326
BALANCE AS OF NOVEMBER 30, 2017		14,308	$	170	$	80,871	$	727	$	(59,027	)	$	22,741


	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.

	August 31, 2021
	Amortized cost		Gross unrealized gains (losses)			Estimated fair value		Average yield to maturity rate
Short-term:
Commercial bonds	$	4,463	$	(98	)	$	4,365		1.73	%
Accrued interest		116		-			116

Long-term		6,692		610			7,302		1.08	%
	$	11,271	$	512		$	11,783

	November 30, 2021		August 31, 2021
Operating right-of-use assets	$	504	$	533

Operating lease liabilities, current		130		130
Operating lease liabilities long-term		374		403
Total operating lease liabilities	$	504	$	533

	November 30, 2021			August 31, 2021
2022	$	118		$	156
2023		140			138
2024		138			136
2025		138			136
Total undiscounted lease payments		534			565
Less: Interest*		(30	)		(32	)
Present value of lease liabilities	$	504		$	533

	●
	●	our belief that our technology has the potential to deliver medications and vaccines orally that today can only be delivered via injection;

	●
	●	the competitive ability of our technology based product efficacy, safety, patient convenience, reliability, value and patent position;

	●
	●	our expectation that in ~~the~~ upcoming years our research and development expenses, net, will continue to be our major expenditure;

	●
	●	our expectations regarding our short- and long-term capital requirements;

	●
	●	our outlook for the coming months and future periods, including but not limited to our expectations regarding future revenue and expenses; ~~and~~

	●
	●	information with respect to any other plans and strategies for our ~~business.~~business; and

	Three months ended
	November 30, 2021			November 30, 2020

Revenues	$	674		$	674
Cost of revenues		-			-
Research and development expenses		6,410			5,774
Sales and Marketing expenses		585			-
General and administrative expenses		1,739			727
Financial income (expenses), net		(38	)		257
Taxes on income		-			-
Net loss for the period	$	8,098		$	5,570
Loss per common share - basic and diluted	$	0.22		$	0.23
Weighted average common shares outstanding		36,672,551			23,754,980

Number		Exhibit

31.1*		Certification of Principal Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended.

31.2*		Certification of Principal Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended.

32.1**		Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350.

32.2**		Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350.
101.1*
101.1*		The following financial statements from the Company’s Quarterly Report on Form 10-Q for the quarter ended November 30, ~~2017,~~2021 formatted in XBRL: (i) Condensed Consolidated Balance Sheets, (ii) Condensed Consolidated Statements of Comprehensive Loss, (iii) Condensed Consolidated Statement of Changes in Stockholders’ Equity, (iv) Condensed Consolidated Statements of Cash Flows and (v) the Notes to Condensed Consolidated Financial Statements.

	25
104.1*		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).

	ORAMED PHARMACEUTICALS INC.

Date: January 11, ~~2018~~2022	By:	/s/ Nadav Kidron
		Nadav Kidron
		President and Chief Executive Officer

Date: January 11, ~~2018~~2022	By:	/s/ ~~Hilla Eisenberg~~David Silberman
		~~Hilla Eisenberg~~David Silberman
		Chief Financial Officer
		(Principal Financial and Accounting Officer)

~~Phase I~~

~~Phase II~~

~~Phase III~~

~~Timeline~~

~~ORMD-0801~~
~~oral insulin~~

~~Type 2 diabetes~~

~~Q1 ’14: Phase IIa completed~~
~~Q2 ’16: Phase IIb multi-center study completed~~
~~Q1 ’17: Phase IIa - dose finding study completed~~
~~Q1 ’18: Phase IIb 90-day multi-center study projected initiation (projected completion Q2 ’19)~~
~~Q4 ’19: Phase III study projected initiation (projected completion Q2 ’21)~~

~~Type 1 diabetes~~

~~Q3 ’14: Phase IIa study completed~~
~~Q1 ’18: Clamp study projected initiation (projected completion Q3 ’18)~~
~~Q4 ’19: Phase III projected initiation (projected completion Q2 ’21)~~

~~ORMD-0901~~
~~oral GLP-1~~

~~Type 2 diabetes~~

~~Q2 ’16: Phase Ib non-US study completed~~
~~Q1 ’18: Pharmacokinetics clinical study projected initiation (projected completion Q3 ’18)~~
~~H2 ’18: Phase II projected initiation (projected completion Q4 ’19)~~