EX-99.1 2 ea168314ex99-1_oramed.htm PRESS RELEASE DATED NOVEMBER 10, 2022

Exhibit 99.1

 

Oramed Reports Third Quarter 2022 Financial Results

 

NEW YORK, November 10, 2022 – Oramed Pharmaceuticals Inc. (“Oramed” or the “Company”) (Nasdaq/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.

 

"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

 

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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 

 

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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 

 

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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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