NEW YORK, Nov. 10, 2022 /PRNewswire/ — Oramed Pharmaceuticals Inc. (“Oramed” or the “Company”) (Nasdaq: ORMP) (TASE: ORMP) (www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery platforms, today reported its financial results for the quarter ended September 30, 2022.

Oramed Pharmaceuticals Inc. Logo

 

“We are pleased to share our quarterly report for the third quarter of 2022. We had a strong quarter filled with important milestones, including positive Phase 2 NASH data and initial positive results from our Phase 1 oral Covid-19 vaccine trial. Over the next few months, we look forward to sharing multiple milestones, most notably topline data from our first Phase 3 oral insulin trial expected in January,” said Oramed Chief Executive Officer, Nadav Kidron. “Oramed remains in a strong financial position with approximately $160 million in cash and investments as of September 30, 2022, allowing us to continue advancing all aspects of our pipeline and giving us sufficient runway to complete our pivotal oral insulin (ORMD-0801) Phase 3 trials and advance us towards potential FDA approval.”

Financial Results for the Three Month Period Ended September 30, 2022  

  • As of September 30, 2022, we had approximately $160 million in cash and investments, comprised of $33,196,000 of available cash, $121,119,000 of short-term bank deposits and $5,234,000 of marketable securities.

  • Research and development expenses for the three month period ended September 30, 2022 decreased by 12% to $5,347,000, compared to $6,086,000 for the three month period ended September 30, 2021. The decrease was mainly due to lower research and development expenses in our subsidiary Oravax Inc. (“Oravax”) in the third quarter of 2022. Stock-based compensation expenses for the three month period ended September 30, 2022 were $771,000, compared to $495,000 during the three month period ended September 30, 2021. This increase was mainly due to equity awards granted to employees in 2022, and equity awards granted by Oravax to employees and board members of Oravax and to other service providers in September 2022.

  • Sales and marketing expenses for the three month period ended September 30, 2022 increased by 169% to $463,000, compared to $172,000 for the three month period ended September 30, 2021. The increase was primarily due to stock-based compensation expenses and consulting expenses. Stock-based compensation costs for the three month period ended September 30, 2022 were $303,000, compared to $142,000 for the three month period ended September 30, 2021. This increase was mainly due to equity awards granted to an employee during fiscal years 2021 and 2022.

  • General and administrative expenses for the three month period ended September 30, 2022 increased by 60% to $3,061,000 compared to $1,909,000 for the three month period ended September 30, 2021. The increase was mainly due to higher stock-based compensation expenses and salary expenses. Stock-based compensation costs for the three month period ended September 30, 2022 were $1,977,000, compared to $644,000 for the three month period ended September 30, 2021. This increase was mainly due to equity awards granted to directors, officers and other employees in 2022, and equity awards granted by Oravax to employees and board members of Oravax and to other service providers in September 2022.

  • Basic and diluted loss per share of common stock for the three month period ended September 30, 2022 decreased by 14% to $0.18, compared to $0.21 for the three month period ended September 30, 2021. The decrease in loss was mainly due to a higher number of weighted average shares of common stock in the three month period ended September 30, 2022 compared to the three month period ended September 30, 2021.

Full financial tables are included below.

About Oramed Pharmaceuticals

Oramed Pharmaceuticals (Nasdaq/TASE: ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, with offices in the United States and Israel, Oramed has developed a novel Protein Oral Delivery (POD™) technology. Oramed is seeking to transform the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which is being evaluated in two pivotal Phase 3 studies and has the potential to be the first commercial oral insulin capsule for the treatment of diabetes. In addition, Oramed is developing an oral GLP-1 (Glucagon-like peptide-1) analog capsule (ORMD-0901).

For more information, please visit www.oramed.com.

Forward-looking statements: This press release contains forward-looking statements. For example, we are using forward-looking statements when we discuss the potential development and timing of an oral COVID-19 vaccine, what our financial position is expected to allow us to achieve, our expectations to share multiple milestones, including topline data from our first Phase 3 oral insulin trial, the expected timing of results of our clinical trials, the expected timing and achievement of milestones and other anticipated future results. In addition, historic results of scientific research and clinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. These forward-looking statements are based on the current expectations of the management of Oramed only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risks and uncertainties related to the progress, timing, cost, and results of clinical trials and product development programs; difficulties or delays in obtaining regulatory approval or patent protection for our product candidates; competition from other pharmaceutical or biotechnology companies; and our ability to obtain additional funding required to conduct our research, development and commercialization activities. In addition, the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; delays or obstacles in launching our clinical trials; changes in legislation; inability to timely develop and introduce new technologies, products and applications; lack of validation of our technology as we progress further and lack of acceptance of our methods by the scientific community; inability to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties that may develop with our process; greater cost of final product than anticipated; loss of market share and pressure on pricing resulting from competition; laboratory results that do not translate to equally good results in real settings; our patents may not be sufficient; and finally that products may harm recipients, all of which could cause the actual results or performance of Oramed to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Oramed undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Oramed, reference is made to Oramed’ s reports filed from time to time with the Securities and Exchange Commission. 

Company Contact:
Zach Herschfus+1-844-9-ORAMED
zach@oramed.com

 

FINANCIAL TABLES

 

 

ORAMED PHARMACEUTICALS INC.

INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS

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

(UNAUDITED)

September 30,

December 31,

2022

2021

Assets

CURRENT ASSETS:

  Cash and cash equivalents

$

33,196

$

27,456

  Short-term deposits

121,119

111,077

  Marketable securities

5,234

7,747

  Prepaid expenses and other current assets

623

1,657

Total current assets

160,172

147,937

LONG-TERM ASSETS:

     Long-term deposits

2

25,094

     Long-term investments

2,700

–

     Marketable securities

–

3,875

     Amounts funded in respect of employee rights upon retirement

23

26

     Property and equipment, net

535

388

     Operating lease right-of-use assets

1,005

500

Total long-term assets

4,265

29,883

Total assets

$

164,437

$

177,820

Liabilities and stockholders’ equity

CURRENT LIABILITIES:

     Accounts payable, accrued expenses and other liabilities

$

4,205

$

4,535

     Deferred revenues

2,022

2,703

     Payable to related parties

70

–

     Operating lease liabilities

228

130

Total current liabilities

6,525

7,368

LONG-TERM LIABILITIES:

     Long-term deferred revenues

4,000

3,340

     Employee rights upon retirement

21

22

     Provision for uncertain tax position

11

11

     Operating lease liabilities

672

370

     Other liabilities

61

99

Total long-term liabilities

4,765

3,842

COMMITMENTS (note 2)

Equity

EQUITY ATTRIBUTABLE TO COMPANY’S STOCKHOLDERS:

Common stock, $0.012 par value (60,000,000 authorized shares; 39,113,236
     and 38,158,792 shares issued and outstanding as of September 30, 2022
     and December 31, 2021, respectively)

470

459

Additional paid-in capital

307,876

292,514

Accumulated deficit

(154,538)

(126,520)

Total stockholders’ equity

153,808

166,453

Non-controlling interests

(661)

157

Total equity

153,147

166,610

Total liabilities and equity

$

164,437

$

177,820

 

 

 

ORAMED PHARMACEUTICALS INC.

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

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

(UNAUDITED)

Nine months ended

Three months ended

September 30,

September 30,

September 30,

September 30,

2022

2021

2022

2021

REVENUES

$

2,022

2,022

$

682

682

RESEARCH AND DEVELOPMENT EXPENSES

20,362

15,452

5,347

6,086

SALES AND MARKETING EXPENSES

1,433

172

463

172

GENERAL AND ADMINISTRATIVE EXPENSES

11,085

4,937

3,061

1,909

OPERATING LOSS

30,858

18,539

8,189

7,485

FINANCIAL INCOME (EXPENSE), NET

1,930

1,031

1,036

(51)

LOSS BEFORE TAX EXPENSES

28,928

17,508

7,153

7,536

TAX EXPENSES

100

–

100

–

NET LOSS FOR THE PERIOD

$

29,028

17,508

$

7,253

7,536

NET LOSS ATTRIBUTABLE TO NON-
     CONTROLLING INTERESTS

1,010

764

193

279

NET LOSS ATTRIBUTABLE TO STOCKHOLDERS

28,018

16,744

7,060

7,257

LOSS PER SHARE

BASIC AND DILUTED LOSS PER SHARE OF
     COMMON STOCK

$

0.72

$

0.54

$

0.18

$

0.21

WEIGHTED AVERAGE NUMBER OF SHARES
     OF COMMON STOCK USED IN
     COMPUTING BASIC AND DILUTED LOSS
     PER SHARE OF COMMON STOCK

38,856,514

31,097,270

39,100,231

34,539,487

 

 

ORAMED PHARMACEUTICALS INC.

INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

U.S. dollars in thousands

(UNAUDITED)

Nine months ended

September 30,

2022

2021

CASH FLOWS FROM OPERATING ACTIVITIES:

Net loss

$

(29,028)

$

(17,508)

Adjustments required to reconcile net loss to net cash used in operating activities:

     Depreciation

41

69

     Non-cash expense for acquired in-process research and development

–

1,040

     Exchange differences and interest on deposits and held to maturity bonds

(933)

429

     Changes in fair value of investments

494

(732)

     Stock-based compensation

8,961

2,896

     Changes in operating assets and liabilities:

     Prepaid expenses and other current assets

1,034

128

     Accounts payable, accrued expenses and related parties

(330)

1,875

     Net changes in operating lease

(105)

–

     Deferred revenues

(21)

(2,022)

     Liability for employee rights upon retirement

(1)

–

     Other liabilities

32

(74)

Total net cash used in operating activities

(19,856)

(13,899)

CASH FLOWS FROM INVESTING ACTIVITIES:

Purchase of held to maturity securities

–

(8,593)

Purchase of short-term deposits

(111,500)

(6,000)

Investment in long-term deposits

–

(25,000)

Proceeds from short-term deposits

128,000

9,500

Proceeds from maturity of held to maturity securities

5,336

6,065

Long-term investments

(2,700)

–

Proceeds from sale of mutual funds

–

3,029

Funds in respect of employee rights upon retirement

3

–

Purchase of property and equipment

(188)

(55)

Total net cash provided by (used in) investing activities

18,951

(21,054)

CASH FLOWS FROM FINANCING ACTIVITIES:

Proceeds from issuance of common stock, net of issuance costs

7,345

74,743

Proceeds from exercise of warrants and options

42

21,496

Transaction with non-controlling interests

–

1,500

Tax withholdings related to stock-based compensation settlements

(783)

–

Total net cash provided by financing activities

6,604

97,739

EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS

41

(3)

INCREASE IN CASH AND CASH EQUIVALENTS

5,740

62,783

CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD

27,456

21,630

CASH AND CASH EQUIVALENTS AT END OF PERIOD

$

33,196

$

84,413

(A) SUPPLEMENTARY DISCLOSURE ON CASH FLOWS –

Interest received

$

906

$

505

(B) SUPPLEMENTARY DISCLOSURE ON CASH FLOWS –

Recognition of operating lease right of use assets and liabilities

$

678

$

–

(C) ASSET ACQUISITION TRANSACTION (see note 8) –

In-process research and development

–

1,040

Transaction with non-controlling interests

–

1,500

Additional paid in capital

–

(1,045)

Non-controlling interests

$

–

$

(1,495)

 

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SOURCE Oramed Pharmaceuticals Inc.