ORAMED PHARMACEUTICALS INC
For the period ended Mar 31, 2025. Filed May 15, 2025.
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Mar 31, 2025 · Filed May 15, 2025
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Notes to Condensed Consolidated Financial Statements
NOTE 1 - GENERAL:
Incorporation and Operations
Oramed Pharmaceuticals Inc. (collectively with its subsidiaries, the “Company”, unless the context indicates otherwise), a Delaware corporation, was incorporated on April 12, 2002.
On May 14, 2007, the Company incorporated a wholly-owned subsidiary in Israel, Oramed Ltd. (the “Subsidiary”), which is engaged in research and development.
On March 18, 2021, the Company entered into a license agreement with Oravax Medical Inc. (“Oravax”) and holds 63% of Oravax’s issued and outstanding share capital on a fully diluted basis, as of the date of issuance. Consequently, Oramed consolidates Oravax in its consolidated financial statements since that time.
On July 1, 2024, the Company incorporated a wholly-owned subsidiary in Nevada, Oramed NewCo, Inc. (“OraTech”), which is intended to serve as the company for the joint venture with Hefei Tianhui Biotech Co., Ltd. (“HTIT”) (see below).
On January 11, 2023, the Company announced that the ORA-D-013-1 Phase 3 trial did not meet its primary or secondary endpoints. As a result, the Company terminated this trial and a parallel Phase 3, ORA-D-013-2 clinical trial. As these results are considered a triggering event, the Company evaluated all of its long lived assets which include fixed assets and operating lease right-of-use assets in the first quarter of 2023 and concluded that no impairment was required.
In 2023, the Company completed an analysis of the data from the ORA-D-013-1 Phase 3 trial and found that subpopulations of patients with pooled specific parameters, such as body mass index (BMI), baseline HbA1c and age, responded well to oral insulin. These subsets exhibited an over 1% placebo adjusted, statistically significant, reduction in HbA1c. Based on this analysis, on September 12, 2024 the Company submitted protocol ORA-D-013-3 Phase 3 to focus on the subpopulations with the higher probability to show efficacy. Moreover, the Company is examining its existing pipeline and has commenced an evaluation process of potential strategic opportunities, with the goal of enhancing value for the Company’s stockholders.
On February 7, 2025, the Company and HTIT entered into a Joint Venture Agreement (the “JV Agreement”), amending the original agreement signed on January 22, 2024. The joint venture (“JV”) was formed with the purpose of advancing the development and commercialization of oral insulin, combining the Company’s proprietary technology and funding with HTIT’s manufacturing capabilities. Through this partnership, the JV is expected to have the technology, resources, and production capacity to bring oral insulin to market.
NOTE 1 - GENERAL (continued):
Incorporation and Operations (continued):
The initial closing of the JV Agreement, initially set on April 30, 2025 but which has not yet occurred, will include an investment of $40,000 by HTIT and $7,500 by the Company into OraTech. Additionally, the Company will transfer all its intellectual property rights to OraTech. Upon completion, OraTech will issue all of its shares to both HTIT and the Company in approximately equal proportion.
The second closing, which was initially set as to close by May 31, 2025, contingent on Nasdaq listing approval, involves a $20,000 investment by HTIT and an additional $7,500 investment by the Company.
The JV Agreement also outlines the spin-off of OraTech, requiring regulatory filings and the distribution of at least 60% of the Company’s equity interest in OraTech to its shareholders. Both the Company and HTIT agreed to a 120-day lock-up period post-listing, restricting share sales.
As part of the JV Agreement, HTIT will receive $20,000 at the initial closing and $10,000 at the second closing under a supply agreement with OraTech. The supply agreement covers both raw materials (insulin, SBTI, etc.) and finished insulin capsules for clinical and commercial applications.
Pursuant to the terms of the JV Agreement, each of the Company, the Subsidiary and HTIT irrevocably released and waived (i) any claims and demands against each other party in connection with an existing Technology License Agreement (“TLA”); and (ii) all rights, obligations and liabilities set out and arising with respect to the performance of the TLA.
Due to ongoing U.S.-China trade tensions, HTIT is currently unable to obtain the necessary regulatory approvals to complete its capital contribution and fulfill its closing obligations under the JV Agreement. These delays have also raised concerns regarding HTIT’s ability to provide supply and manufacturing support in the near term.
As a result, the closing of the JV Agreement is currently on hold. Consequently, the Company has paused plans to initiate the Phase 3 clinical trial in the U.S. pending further clarity. The Company is evaluating whether a modified structure with HTIT is feasible under current conditions and concurrently exploring alternative partners and pathways to advance the program independently.
See note 4 regarding 2023 Scilex Transaction and 2024 Refinancing.
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES:
| a. | Condensed consolidated financial statements preparation |
The condensed consolidated financial statements included herein have been prepared in accordance with United States generally accepted accounting principles (“U.S. GAAP”) and, on the same basis as the audited consolidated financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 (the “2024 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 2024 Form 10-K. The results for interim periods are not necessarily indicative of a full fiscal year’s results.
| b. | Income (loss) per share of common stock |
Basic income (loss) per common stock are computed by dividing the net earnings (loss) attributable to stockholders for the period by the weighted average number of shares of common stock outstanding for each period, including vested restricted stock units (“RSUs”). Outstanding stock options, warrants and unvested RSUs have been excluded from the calculation of the diluted loss per share for the three months ended March 31, 2025 because all such securities are anti-dilutive for the three months ended March 31, 2025.
For the diluted earnings per share calculation for the three months ended March 31, 2024, the weighted average number of shares outstanding during the period is adjusted for the potential dilution that could occur in connection with employee share-based payment, using the treasury stock method. The difference in the denominator results from the dilutive impact of 233,200 RSUs.
The weighted average number of stock options, warrants and RSUs excluded from the calculation of diluted income (loss) per share was 4,975,471 and 4,846,474 for the three months ended March 31, 2025 and 2024, respectively.
| c. | Recently issued accounting pronouncements, not yet adopted |
In December 2023, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2023-09 “Income Taxes (Topic 740): Improvements to Income Tax Disclosures.” This guidance is intended to enhance the transparency and decision-usefulness of income tax disclosures. The amendments in ASU 2023-09 address investor requests for enhanced income tax information primarily through changes to disclosure regarding rate reconciliation and income taxes paid both in the U.S. and in foreign jurisdictions. ASU 2023-09 is effective for fiscal years beginning after December 15, 2024 on a prospective basis, with the option to apply the standard retrospectively. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures.
In November 2024, the FASB issued ASU 2024-03 “Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40): Disaggregation of Income Statement Expenses”, which requires disclosure about the types of costs and expenses included in certain expense captions presented on the income statement as well as disclosures about selling expenses. ASU 2024-03 is effective for years beginning after December 15, 2026, and interim periods within years beginning after December 15, 2027, with early adoption permitted, and may be applied either prospectively or retrospectively. The Company is currently evaluating this guidance to determine the impact it may have on its consolidated financial statements disclosures.
| d. | Fair value |
The Company measures fair value and discloses fair value measurements for financial assets and liabilities. Fair value is based on the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. In order to increase consistency and comparability in fair value measurements, the guidance establishes a fair value hierarchy that prioritizes observable and unobservable inputs used to measure fair value into three broad levels, which are described as follows:
| Level 1: | Quoted prices (unadjusted) in active markets that are accessible at the measurement date for assets or liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs. |
| Level 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. |
The Company’s financial assets subject to fair value measurements on a recurring basis and the level of inputs used in such measurements were as follows:
| Level 1 | Level 2 | Level 3 | Total | |
|---|---|---|---|---|
| Assets: | ||||
| Marketable Securities | ||||
| DNA (as defined below) | 445 | - | - | 445 |
| Entera (as defined below) | 199 | - | - | 199 |
| Scilex (as defined below) | 3,051 | - | - | 3,050 |
| Loan to an equity method investee (see note 6) | - | - | 4,265 | 4,265 |
| Tranche A Note (see note 4) | - | - | 12,268 | 12,268 |
| Subsequent Penny Warrants (see note 4) | - | 1,625 | - | 1,625 |
| Tranche B Note (see note 4) | - | - | 13,733 | 13,733 |
| Warrants Note B (see note 4) | - | - | 184 | 184 |
| Royalty Purchase Agreement (see note 4) | - | - | 1,906 | 1,906 |
| Profit Sharing Loan Agreement (see note 4) | 1,382 | 1,382 | ||
| $3,695 | $1,625 | $33,738 | $39,057 | |
| d. | Fair value (continued) |
| Level 1 | Level 2 | Level 3 | Fair Value | |
|---|---|---|---|---|
| Assets: | ||||
| Marketable Securities | ||||
| DNA | 424 | - | - | 424 |
| Entera | 248 | - | - | 248 |
| Scilex | 2,769 | - | - | 2,769 |
| Tranche A Note (see note 4) | - | - | 13,714 | 13,714 |
| Subsequent Penny Warrants (see note 4) | - | 2,772 | - | 2,772 |
| Tranche B Note (see note 4) | - | - | 15,798 | 15,798 |
| Warrants Note B (see note 4) | - | - | 548 | 548 |
| Royalty Purchase Agreement (see note 4) | - | - | 1,976 | 1,976 |
| Profit Sharing Loan Agreement (see note 4) | - | - | 1,367 | 1,367 |
| $3,441 | $2,772 | $33,403 | $39,616 | |
As of March 31, 2025 and December 31, 2024, the carrying amounts of cash equivalents, short-term deposits, and accounts payable approximate their fair values due to the short-term maturities of these instruments.
The amounts funded in respect of employee rights are stated at cash surrender value which approximates its fair value.
| e. | Revenue recognition |
HTIT
On November 30, 2015, the Company entered into a TLA, with HTIT and on December 21, 2015, the parties entered into an amended and restated technology license agreement that was further amended by the parties on June 3, 2016 and July 24, 2016 (the “HTIT License Agreement”).
As of December 31, 2024, an aggregate amount of $22,382 was allocated to the HTIT License Agreement, all of which were received through December 31, 2024. Through December 31, 2024, the Company recognized revenue associated with this agreement in the aggregate amount of $20,382, and deferred the remaining amount of $2,000, which was presented as long-term deferred revenues on the consolidated balance sheet as of December 31, 2024.
Through March 31, 2025, the Company recognized revenue associated with the HTIT License Agreement in an aggregate amount of $22,382, of which $2,000 was recognized in the three months ended March 31, 2025 following HTIT's waiver of any claims and demands against the company which was signed in connection with the JV Agreement.
| e. | Revenue recognition (continued) |
Medicox
On November 13, 2022, the Company entered into a distribution license agreement (“Medicox License Agreement”) with Medicox Co., Ltd. (“Medicox”). The Medicox License Agreement grants Medicox an exclusive license to apply for regulatory approval and distribute ORMD-0801 in the Republic of Korea.
The Medicox License Agreement contains a fixed consideration of $2,000, which was received by the Company during the year ended December 31, 2022 and is currently presented under long-term deferred revenues.
The Company’s obligation to stand-ready and support Medicox will be recognized on a straight-line basis over the period the Company expects to provide support to Medicox. As of March 31, 2025, this support has not commenced, and no revenue was recognized from the Medicox License Agreement.
If Medicox proceeds with the regulatory approval process in the Republic of Korea, the Company expects most of the revenue to be recognized at a later stage, going forward. If Medicox chooses to terminate the agreement as a result of the outcome of the Phase 3 trials, the Company will accelerate revenue recognition and recognize it at such time.
NOTE 3 - MARKETABLE SECURITIES
The Company’s marketable securities include investments in equity securities of DNA Group (T.R.) Ltd. (“DNA”), Entera Bio Ltd. (“Entera”) and Scilex Holding Company (“Scilex”) at fair value with changes in fair value recognized in earnings.
Composition
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Short -term: | ||
| DNA | $445 | $424 |
| Entera | 199 | 248 |
| Scilex | 3,051 | 2,769 |
| $3,695 | $3,441 | |
NOTE 4 - INVESTMENTS, AT FAIR VALUE
2023 Scilex Transaction and 2024 Refinancing
On April 14, 2025, Scilex effected a 1-for-35 reverse stock split of its issued and outstanding common stock. As a result, every 35 shares of Scilex common stock were automatically reclassified into 1 share of common stock, with fractional shares rounded up to the nearest whole share. The numbers below reflect the reverse split effect.
2023 Scilex Transaction
On September 21, 2023, the Company entered into and consummated the transactions (collectively, the “2023 Scilex Transaction”) contemplated by a securities purchase agreement with Scilex, pursuant to which Scilex issued to the Company:
| a. | A senior secured promissory note (the “Tranche A Note”), with a principal amount of $101,875, maturing on March 21, 2025 and bearing interest of SOFR plus 8.5%, payable in-kind. Scheduled principal payments are due on December 21, 2023, March 21, 2024, June 21, 2024, September 21, 2024, and December 21, 2024, with the balance due on March 21, 2025. |
On September 20, 2024, the Company and Scilex entered into an extension agreement (the “Extension Agreement”) to extend the due date of the September 21, 2024 payment. Pursuant to the Extension Agreement, Scilex paid to the Company $2,000 on September 23, 2024, which payment is to be applied as follows: (i) $1,700 to the payment due under the Tranche A Note on March 21, 2025 and (ii) $300 to purchase the Transferred Warrants. In January 2025, the Company extended Tranche A Note’s maturity from March 21, 2025 to December 31, 2025 (the “Extended Maturity Date”). Interest will continue to accrue and be payable on the Extended Maturity Date. In consideration of the extension, the Company received 92,858 shares of Scilex Common Stock. As per the Tranche A Note terms, if the Tranche A Note is not repaid in full on or prior to March 21, 2024, an exit fee of $3,056 is due. Since the Tranche A Note was not repaid by that date, the Company is entitled to the above-mentioned exit fee at the Extended Maturity Date of the Tranche A Note. No payments were received from Scilex in connection with Tranche A note during the three months ended on March 31, 2025. As of March 31, 2025, Scilex has repaid $69,200 of the amount due under the Tranche A Note.
The Tranche A Note constitutes senior secured indebtedness of Scilex and is guaranteed by all existing or future formed, direct and indirect, domestic subsidiaries of Scilex and is secured by a first priority security interest and liens on all of the assets of Scilex, subject to customary and mutually agreed permitted liens and except for certain specified exemptions.
NOTE 4 - INVESTMENTS, AT FAIR VALUE (continued)
2023 Scilex Transaction and 2024 Refinancing (continued)
2023 Scilex Transaction (continued)
| b. | Warrants to purchase up to 128,572 shares of Scilex common stock with an exercise price of $0.35 per share (the “Closing Penny Warrants”) and four additional warrants (the “Subsequent Penny Warrants”) each for 60,715 shares of Scilex common stock with an exercise price of $0.35 per share. The Closing Penny Warrants were vested on September 21, 2023, and each of the Subsequent Penny Warrants vested quarterly during 2024. |
| c. | Transferred warrants (the “Transferred Warrants”) to purchase 4,000,000 shares of Scilex common stock with an exercise price of $11.50 per share, fully exercisable and expiring on November 10, 2027. On September 20, 2024, the Company sold the Transferred Warrants for consideration of $300 (see below). As a result, as of March 31, 2025 the Company does not hold any Transferred Warrants. |
According to the Extension Agreement (as defined below), as of December 31, 2024, 128,572 Closing Penny Warrants and 57,143 Subsequent Penny Warrants have become exercisable. On October 30, 2024, the Company exercised 128,572 Closing Penny Warrants and 57,143 Subsequent Penny Warrants that were exercisable at such time. As a result, the Company holds 185,715 shares of common stock of Scilex.
Following the 2024 Refinancing (as defined and described below), on October 8, 2024, Scilex used $12,500 of the net proceeds from the proceeds of the Tranche B Notes for the partial repayment of the outstanding balance under the Tranche A Note.
The Company elected the fair value option for the Tranche A Note and the Penny Warrants in order to reduce operational complexity of bifurcating embedded derivatives. Changes in value are recorded under financial income (expense), net and include interest income on the Tranche A Note.
The valuation was performed based on several scenarios. Each scenario took into consideration the present value of the Tranche A Note’s cash flows (including the exit fee and the prepayment premium) and the Warrants’ value. The total value of the 2023 Scilex Transaction (and of each of its components) was valued on a weighted average of the different scenarios.
The discount rate of the Tranche A Note was based on the B- rating zero curve in addition to a risk premium which takes into account the credit risk of Scilex and ranged between 129.7% to 131.4%.
The fair value of the Penny Warrants was calculated based on the closing price of the Scilex common stock on the Nasdaq Capital Market.
2023 Scilex Transaction and 2024 Refinancing (continued)
2023 Scilex Transaction (continued)
The table below represents the fair value composition of the Tranche Note A:
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Tranche A Note | $12,268 | $13,714 |
| Subsequent Penny Warrants | $1,625 | $2,772 |
| Total | $13,893 | $16,486 |
As of March 31, 2025 and December 31, 2024, the Tranche A Note is included under Investments at fair value, current assets.
As of December 31, 2024, the fair value of the Tranche A Note was less than the aggregate unpaid principal balance (which includes interest payable on maturity) by $8,114.
As of March 31, 2025, the fair value of the Tranche A Note was less than the aggregate unpaid principal balance (which includes interest payable on maturity) by $10,268.
2024 Refinancing
In October 2024, the Company entered into the following transactions (collectively, the “2024 Refinancing”) pursuant to which Scilex issued to the Company:
a. Convertible Notes SPA
The Company entered into a securities purchase agreement (the “Convertible Notes SPA”) with the other Tranche Note B holders (together with the Company, the “Buyers”) and Scilex to refinance a portion of the Tranche A Note and pay off certain other indebtedness of Scilex. Pursuant to the Convertible Notes SPA, the Buyers purchased in a registered offering by Scilex (i) a new tranche B of senior secured convertible notes of Scilex in the aggregate principal amount of $50,000 (the “Tranche B Notes”) repayable on a quarterly basis for 2 years, which Tranche B Notes are convertible into shares of Scilex common stock and (ii) warrants to purchase up to 214,286 shares of Scilex common stock with an exercise price of $36.4 (the “Tranche B warrants”). The Company purchased 50% of Tranche B Notes and Tranche B Warrants and therefore holds an aggregate principal amount of $25,000 of the Tranche B Notes and 107,143 Tranche B Warrants.
Scilex received from the Company, in consideration of the Tranche B Note and the Tranche B Warrants issued to the Company, an exchange and reduction of the principal outstanding balance under the Tranche A Note of $22,500.
b. Royalty Purchase Agreement
The Company and the other Tranche Note B holders (together with the Company, the “RPA Purchasers”) entered into a Purchase and Sale Agreement (the “Royalty Purchase Agreement”) with Scilex and Scilex Pharmaceuticals Inc. (“Scilex Pharma”). Pursuant to the Royalty Purchase Agreement, the RPA Purchasers acquired the right to receive, in the aggregate,8% of net sales worldwide for 10 years (the “Purchased Receivables”) with respect to ZTlido (lidocaine topical system)1.8%, SP-103 (lidocaine topical system)5.4%, and any related, improved, successor, replacement or varying dosage forms of the foregoing. The Company acquired the right to receive 50% of the Purchased Receivables and therefore holds the right to receive 4% royalties.
In consideration for its interest in the Purchased Receivables, the Company exchanged and reduced $2,500 of the principal balance under the Tranche A Note.
c. ZTlido Rest of the World Binding Agreement
The Company and certain other institutional investors and Scilex entered into a binding term sheet (“ROW License Term Sheet”), regarding a license and development agreement, with respect to services, compositions, products, dosages and formulations comprising lidocaine, including without limitation, the product and any future product defined as a “Product” under Scilex Pharma’s existing (i) Product development agreement, dated as of May 11, 2011, with Oishi Koseido Co., Ltd. (“Oishi”), and Itochu Chemical Frontier Corporation (“Itochu”), as amended, and (ii) the associated commercial supply agreement, dated February 16, 2017, between Scilex, Oishi and Itochu, as amended.
The Company and such institutional investors hold this license through RoyaltyVest. See note 6 for additional information about RoyaltyVest.
The institutional investors who are parties to the Convertible Notes SPA, Royalty Purchase Agreement and the ZTLido License Agreement are all inter-related.
Tranche B Note Consent
On January 2, 2025, the Company and other Tranche B Note holders entered into deferral and consent agreements with Scilex (the “Tranche B Consent”), deferring Scilex’s first amortization payment under the Tranche B Notes to October 8, 2026. In consideration, the Company received $877 ($500 of the principal amount and $372 accrued interest), and 71,429 Scilex Common Stock shares.
In addition, as part of the Tranche B Consent and contingent upon certain conditions that were met:
| ● | Scilex and the Tranche B Note holders agreed to a 10-year, assignable 4% royalty on global net sales of Gloperba and Elyxyb, excluding Elyxyb sales in Canada, with the Company entitled to 2%. Gloperba, an oral liquid colchicine formulation for gout, and Elyxyb, an oral solution for acute migraine treatment, represent key assets in Scilex’s portfolio. The definitive agreement was signed on February 28, 2025. |
| ● | The Tranche B Note holders have the option, through RoyaltyVest, to fund up to 50% of the cash purchase price for Ex-U.S. product rights to Gloperba and Elyxyb (excluding Elyxyb in Canada) and will receive proportional revenues from commercialization and licensing. As of March 31, 2025, RoyaltyVest exercised its option to Ex-U.S. product rights of Gloperba for $500. See Note 6 for further details. |
The Company elected the fair value option for the Tranche B Note and the Royalty Purchase Agreement, The Note B Warrants meet the definition of a derivative and therefore will be measured at fair value. Changes in value are recorded under financial income (expense), net and include interest income on the Tranche B Note.
The valuation of the Tranche B Note’s was performed based on the binomial model, using a discount rate of 129.2%. Presented below is the summary of the assumptions and estimates that were used for the valuation as of March 31, 2025:
| Parameters and Assumptions | |
|---|---|
| Share Price | $8.75 |
| Conversion Rate | 36.4 |
| Floor Rate | 36.4 |
| Expected Term | 1.52 Years |
| Volatility | 62.74% |
| Risk Free Rate | 3.92% |
The fair value of the Note B Warrants was calculated based on Black and Scholes model.
Presented below is the summary of the assumptions and estimates that were used for the valuation of the Warrants as of March 31, 2025:
| Parameters and Assumptions | |
|---|---|
| Share Price | $8.75 |
| Exercise Price | $36.4 |
| Expected Term | 4.53 Years |
| Volatility | 61.74% |
| Risk Free Rate | 3.91% |
| Dividend Rate | 0% |
The value of the Royalty Purchase Agreement was calculated according to the royalty payment schedule and the aggregation of discounted cash flows derived from the royalty payments, using a discount rate of 129.2%.
As of December 31, 2024, the fair value of the Tranche B Note was less than the aggregate unpaid principal balance (which includes interest payable on maturity) is $9,833.
As of March 31, 2025, the fair value of the Tranche B Note was less than the aggregate unpaid principal balance (which includes interest payable on maturity) is $11,360.
The table below represents the fair value composition of the Tranche B Note:
| March 31, 2025 | December 31, 2024 | |||||
|---|---|---|---|---|---|---|
| Short term | Long term | Total | Short term | Long term | Total | |
| Tranche Note B | $10,814 | 2,919 | $13,733 | $11,263 | $4,535 | $15,798 |
| Warrant | - | 184 | 184 | - | $548 | $548 |
| Royalty Purchase Agreement | $1,025 | 881 | $1,906 | 1,039 | $937 | $1,976 |
| Total | $11,839 | 3,984 | $15,823 | $12,302 | $6,020 | $18,322 |
Scilex Transaction Summary
The table below represents the fair value cycle of 2023 Scilex Transaction and 2024 Refinancing transaction throughout December 31, 2024 and March 31, 2025:
| Tranche A · Tranche B · Total | |||||
|---|---|---|---|---|---|
| Balance as of December 31, 2023 | $110,188 | - | $110,188 | ||
| 2024 Refinancing | (21,575) | 25,000 | 3,425 | ||
| Proceeds from the sale of Transferred Warrants | (300) | - | (300) | ||
| Cash received from Tranche A Note repayment | (64,200) | - | (64,200) | ||
| Exercised warrants (*) | (6,123) | - | (6,123) | ||
| Amounts receivable from the royalty agreement | - | (398) | (398) | ||
| Change in fair value | (1,504) | (6,280) | (7,784) | ||
| Balance as of December 31, 2024 | 16,486 | 18,322 | 34,808 | ||
| Amounts receivable from the royalty agreement (**) | - | (208) | (208) | ||
| Principal payments | (500) | (500) | |||
| Interest payments | (377) | (377) | |||
| Change in fair value | (2,593) | (1,414) | (4,007) | ||
| Balance as of March 31, 2025 | $13,893 | $15,823 | $29,716 | ||
| (*) | On October 30, 2024 the Company exercised 128,572 Closing Penny Warrants, and 57,143 Subsequent Penny Warrants into 185,715 shares of common stock of Scilex and as a result, these shares are not part of the Tranche A Note and presented under Marketable securities. |
|---|
| (**) | The amount is included under prepaid expenses and other current assets. |
|---|
Financial income (expenses) recognized in respect of the 2023 Scilex Transaction and the 2024 Refinancing, for the three months ended March 31, 2025 and 2024, were ($3,616) and $3,552, respectively.
Scilex Transaction Summary (continued)
The table below represents the fair value breakdown as of March 31, 2025:
| Tranche A Note · Tranche B Note · Total | |||||
|---|---|---|---|---|---|
| Amount | Fair Value | Amount | Fair Value | Fair Value | |
| The Notes (*) | $7,675 | $12,268 | $24,500 | $13,733 | $26,001 |
| Warrants | 185,715 | $1,625 | 107,143 | $184 | $1,809 |
| Royalty Purchase Agreement payment | - | - | - | $1,906 | $1,906 |
| March 31, 2025 | - | $13,893 | - | $15,823 | $29,716 |
| (*) | the note amount represents the principal amount under the note and excluding the accrued interest |
|---|
In addition, as a result of the exercise of Transferred Warrants and the Subsequent Penny Warrants, the Tranche A extension agreement and the Tranche B Consent, as of March 31, 2025 the Company holds 350,000 shares of common stock of Scilex. In addition, as of March 31, 2025, the Company holds 185,715 Subsequent Penny Warrants which are fully vested and exercisable.
Profit Sharing Loan Agreement
On September 4, 2024, the Company entered into a loan agreement (the “Profit Sharing Loan Agreement”) with Rabi Binyamin 4 Tama 38 Ltd. (the “Borrower”) to finance a real estate project (the “Project”). According to the terms of the Profit Sharing Loan Agreement, Oramed agreed to loan NIS 5.5 million ($1,523) (the “Loan Principal”) to the Borrower. NIS 4.7 million ($1,307) was loaned upon signing the Profit Sharing Loan Agreement and an additional NIS 0.8 million ($216) will be loaned upon certain milestones which are expected to occur in the first half of 2025. Upon completion of the Project, the Company is entitled to receive the Loan Principal and the greater of: (i)20% annual interest of the Loan Principal and (ii)40% of the Project profits.
The Company decided to designate the Profit Sharing Loan Agreement as a whole under the Fair-Value option in accordance with Accounting Standards Codification (“ASC”) Topic 825 “Financial Instruments”. The valuation of the Profit Sharing Loan Agreement was based on various project profit scenarios derived from an appraiser’s report. The Company used the Wang Transform model, a risk-neutral probabilities method, with an expected term of 3.76 years, a curve rate of 14.25% and a risk spread of 0.43%.
NOTE 5 - ADVANCE PAYMENTS FOR REAL ESTATE
Real Estate – Castel
In January 2025, the Company entered into an agreement to acquire a parcel of land in Mevaseret Zion, Israel for a total purchase price of NIS 5,800 ($1,586). The transaction is structured in installments, and as of March 31, 2025, the Company has paid $1,041 toward the acquisition price and $180 for related costs. The Company intends to pursue value-enhancing activities in connection with the land, with the goal of increasing its potential return upon future sale. The amount is included under Advance payments for real-estate, long term assets.
NOTE 6 - EQUITY METHOD INVESTEE
On October 8, 2024, the Company and certain other investors (“Additional Holders of Note B”) entered into a refinance agreement with Scilex. As part of the refinancing, the Company and the Additional Holders of Note B were granted rights to receive royalties from certain Scilex products. In connection with these rights, on January 2, 2025, the Additional Holders of Note B established RoyaltyVest Ltd. (“RoyaltyVest”), a company incorporated in the British Virgin Islands. On February 12, 2025, the Additional Holders of Note B transferred to the Company 50% of the issued and outstanding capital stock of RoyaltyVest.
As of March 31, 2025, the Company held a 50% equity interest in RoyaltyVest. The Company accounts for this investment using the equity method. The amount of the investment was $640 as of March 31, 2025.
There are no unrecognized losses, guarantees, or commitments related to RoyaltyVest. In addition, no impairment losses were recorded during the reporting period.
In addition to its original investment in RoyaltyVest, the Company is using RoyaltyVest as a potential investment vehicle for additional transactions conducted in collaboration with the other shareholders of RoyaltyVest.
As such, On March 4, 2025, the Company entered into a loan agreement with RoyaltyVest pursuant to which the Company made a loan to RoyaltyVest in the amount of $7,000 to purchase shares of by BioXcel Therapeutics, Inc. (Nasdaq: BTAI) (“BioXcel”). The loan is non-interest bearing and is non recourse to the BioXcel shares. Repayment of the outstanding principal shall be made from the proceeds of sales of BioXcel shares. The company elected to measure the loan at fair value option, and as such it is presented at fair value. During the three months ended March 31, 2025, the Company received $2,736 of the principal amount from RoyaltyVest from the sales of BioXcel.
NOTE 6 - EQUITY METHOD INVESTEE (continued):
The transactions below were carried out by RoyaltyVest:
| a. | ZTlido License Agreement |
As part of the ROW License Term Sheet signed with Scilex under the Tranche B Note, on February 22, 2025, RoyaltyVest, entered into an additional License Agreement with Scilex (“ZTLido License Agreement”). Under the ZTLido License Agreement, RoyaltyVest acquired exclusive rights to develop, manufacture, and commercialize lidocaine-based products, including ZTlido (lidocaine topical system 1.8%) and SP-103, outside the United States. As part of the arrangement, RoyaltyVest and Scilex will each receive 50% of the net profits from the commercialization of these products.
In consideration for the rights to be provided under the proposed ZTLido License Agreement, as more fully described in the ZTLido License Agreement, (a) RoyaltyVest will invest (whether through cash consideration or in-kind payment through the provision of services) $200 per year toward expanding the Product, (b) Scilex will grant RoyaltyVest a worldwide, exclusive right, license and interest to all products rights for the development, out-licensing, commercialization of any Product outside of the United States and other territories, other than certain excluded designated territories ( “ROW Territory”), and (c) each of RoyaltyVest and Scilex will receive 50% percent of the net revenue (less expenses) generated from any product in the ROW Territory.
| b. | Ex-U.S. product rights to Gloperba |
On February 28, 2025, RoyaltyVest entered into a worldwide (excluding the U.S.) license agreement for Gloperba products, as defined under the License and Commercialization Agreement between RxOmeg Therapeutics LLC and Scilex, dated June 14, 2022, as amended on January 16, 2025 (the “Gloperba License Agreement”). Under the Gloperba License Agreement, RoyaltyVest was granted an exclusive (including as to Scilex Pharma) license to all product-related rights worldwide to develop, manufacture, obtain regulatory approvals for, commercialize, and otherwise exploit the Gloperba products in the licensed territory. RoyaltyVest and Scilex will each be entitled to receive 50% of the net revenue generated from the commercialization of the Gloperba products.
| c. | BioXcel |
On March 4, 2025, RoyaltyVest participated in a registered direct offering by BioXcel, acquiring 188,383 shares of BioXcel’s common stock,3,811,617 pre-funded warrants and accompanying warrants to purchase up to an additional 4,000,000 shares for a total consideration of $14,000. The warrants have an exercise price of $4.20 per share, are immediately exercisable, and will expire five years from the date of issuance. The pre-funded warrants have an exercise price of $0.001 per share, and are immediately exercisable with no expiration date.
As of March 31, 2025 RoyaltyVest has sold 1,739,984 shares for $5,472 and continued to hold 136,071 shares of BioXcel common stock and 2,123,941 pre-funded warrants.
NOTE 7 - COMMITMENTS:
| a. | Grants from the Israel Innovation Authority (“IIA”) |
Under the terms of the Company’s funding from the IIA, royalties of 3% are payable on sales of products developed from a project so funded, up to a maximum amount equaling 100%-150% of the grants received (dollar linked) with the addition of interest at an annual rate based on SOFR.
At the time the grants were received, successful development of the related projects was not assured. The total amount received through December 31, 2024 was $2,213 ($2,570 including interest).
On February 18, 2025, the Company received approval from the IIA to transfer all of its IIA-funded technology to OraTech in accordance with the terms of the JV Agreement. This approval was granted upon the condition that the Company pays the aggregate IIA grant amount, plus accrued interest, less all royalties paid to date.
On February 27, 2025, the Company fulfilled its payment obligation by remitting $2,046 to the IIA, and as result the Company has no further obligations to the IIA. This amount is recognized in cost of revenue during the three months ended March 31, 2025.
| b. | Clinical Research Organization Services Agreement |
On September 23, 2024, the Subsidiary entered into a Clinical Research Organization Services Agreement with a third party, to retain it as a clinical research organization (“CRO”). The services covered by the agreement include strategic planning, expert consultation, data processing, regulatory, clerical, project management and other research and development services requested by the Company for the Phase 3 clinical trial. As consideration for its services, the Company will pay the CRO a total amount of $11,577 during the term of the engagement and based on achievement of certain milestones, of which $1,070 recognized in research and development expenses through March 31, 2025.
| c. | Loan Agreement |
On March 24, 2025, the Company entered into a loan agreement with Hapisga Project – New Talpiot Ltd. to finance a purchase of a real estate asset in Jerusalem, Israel in the amount of $22,650 (“Hapisga”). The Company lent the amount with a one-year maturity, and a caveat was registered on the property reflecting a commitment to register a first-ranking mortgage on a property which valued at approximately $800,000, providing significant collateral coverage. The loan bears an annual interest rate of 12%.
In addition, in March 2025, the Company entered into an additional loan agreement with Tova Chochma Im Nachala Ltd. (“Tova Chochama”) in the amount of $5,000. The loan bears an annual interest rate of 12%. The original maturity of the loan was set to be 14 days which was further extended, in April 2025, to up to 12 months. Tova Chochama can repay the loan at any time, with interest accruing until the date of actual repayment. This loan is also secured by the registration of the caveat for Hapisga.
In April 2025, the Company paid $27,650 in connection with the loans to Hapisga and to Tova Chocma.
NOTE 8 - ACCOUNTS PAYABLE AND ACCRUED EXPENSES:
Composition:
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Accounts payable | $509 | $789 |
| Payroll and related accruals | 178 | 407 |
| Income tax | 3,788 | 3,204 |
| Accrued liabilities | 800 | 740 |
| $5,275 | $5,140 |
NOTE 9 - STOCKHOLDERS’ EQUITY:
Stock -based compensation
Below is a table summarizing all of the RSUs grants to employees made during the three months ended March 31, 2025.
| No. of RSUs granted · Exercise price · Vesting period · Fair value at grant (*) | |||||
|---|---|---|---|---|---|
| Employees | 1,023,540 | - | (** | ) | $2,465,430 |
| (*) | The RSUs’ fair value is based on the Company’s share price on the Nasdaq Capital Market on the grant dates. |
|---|
| (**) | Vesting in 12 equal quarterly installments starting January 1, 2025. |
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Performance restricted stock units (“PSUs”) granted
On January 2, 2025, the Company granted 328,500 PSUs representing a right to receive shares of the Company’s common stock to the Company’s executive officers. The total amount of the PSUs shall vest upon at the earliest of (1) the closing of a joint venture transaction with HTIT; or (2) the repayment to the Company of the value of its principal investment in Scilex plus 10%. The total fair value of these PSUs on the date of grant was $792 based on the quoted closing market share price of $2.41 on the Nasdaq Capital Market on the date of grant.
The Board modified 294,000 outstanding PSUs that were granted to the Company’s executive officers adjusting the vesting criteria from market condition to performance targets, as mentioned above. The incremental fair value arising from the modification was $13.
As of March 31, 2025, the PSUs granted to the Company’s executive officers were deemed to have achieved the first updated performance target. As a result, the Company recognized stock-based compensation expense of $197 for the three months ended March 31, 2025, equal to the unrecognized grant-date fair value of the original award plus the incremental fair value arising from the modification.
NOTE 9 - STOCKHOLDERS’ EQUITY (continued):
Buyback program
In June 2024, the Company’s board of directors authorized a stock buyback program pursuant to which the Company may, from time to time, repurchase and retire up to $20,000 in maximum value of its common stock. Share repurchases may be executed through various means, including, without limitation, open market transactions, privately negotiated transactions or otherwise in compliance with Rule 10b-18 under the Securities Exchange Act of 1934, as amended. The stock buyback program does not obligate the Company to purchase any shares and expires in June 2025. The authorization for the stock buyback program may be terminated, increased or decreased by the Company’s board of directors in its discretion at any time.
During the three months ended March 31, 2025, the Company has not repurchased and retired shares of its common stock under this program.
NOTE 10 - LEASES:
The Company has various operating leases for office space and vehicles that expire through 2027. Below is a summary of the Company’s operating right-of-use assets and operating lease liabilities as of March 31, 2025 and December 31, 2024:
| March 31, 2025 | December 31, 2024 | |
|---|---|---|
| Operating right-of-use assets | $342 | $414 |
| Operating lease liabilities, current | 181 | 216 |
| Operating lease liabilities long-term | 120 | 156 |
| Total operating lease liabilities | $301 | $372 |
Lease payments for the Company’s right-of-use assets over the remaining lease periods as of March 31, 2025 and December 31, 2024 are as follows:
| March 31, 2025 · December 31, 2024 | ||
|---|---|---|
| 2025 | 154 | 225 |
| 2026 | 139 | 141 |
| 2027 | 18 | 18 |
| Total undiscounted lease payments | 311 | 384 |
| Less: Interest* | (10) | (12) |
| Present value of lease liabilities | $301 | $372 |
| * | Future lease payments were discounted by 3%-7% interest rate. |
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NOTE 11 - SEGMENT REPORTING:
The Company’s Chief Executive Officer, serving as the Chief Operating Decision Maker (CODM), evaluates operational performance and makes resource allocation decisions based on net income (loss), which is reported in the consolidated statements of comprehensive income (loss). The Company has determined that it operates in a single reportable segment, focused on research and development activities related to its proprietary products and technologies.
The CODM monitors budgeted versus actual net income (loss), using this measure to assess segment performance and guide financial planning, which is consistent with the financial statements. In addition to its research and development activities, the Company holds financial investments, including a material investment in Scilex, see note 4. The CODM monitors these investments separately from operational performance. Income and expenses related to financial instruments are reported as finance income (expenses) in the consolidated statements of comprehensive income (loss), reflecting their distinct nature from core business operations.
NOTE 12 - RELATED PARTY TRANSACTIONS:
Chief Scientific Officer
On July 1, 2008, the Subsidiary entered into a consulting agreement with KNRY Ltd. (“KNRY”), an Israeli company owned by the Company’s Chief Scientific Officer, whereby the Chief Scientific Officer, through KNRY, provides services to the Company (the “Consulting Agreement”). The Consulting Agreement is terminable by either party upon 140 days prior written notice. The Consulting Agreement, as amended, provides that KNRY will be reimbursed for reasonable expenses incurred in connection with performance of the Consulting Agreement.
Effective as of July 1, 2024, the monthly consulting fee of the Chief Scientific Officer is NIS 134,550 ($37).
Effective as of April 1, 2025, the Company entered into a consulting agreement with KNRY, whereby the Chief Scientific Officer, through KNRY, provides services as Chief Scientific Officer of the Company. The agreement is terminable by either party upon 140 days prior written notice. The agreement provides that KNRY will be reimbursed for reasonable expenses incurred in connection with performance of the agreement. The Chief Scientific Officer receives a monthly consulting fee of NIS 67,275 ($18). Pursuant to the agreement, KNRY and the Chief Scientific Officer each agree that during the term of the agreement and for a 12-month period thereafter, none of them will compete with the Company nor solicit employees of the Company.
In addition, the Company, through the Subsidiary, has entered into an employment agreement with the Chief Scientific Officer, effective as of April 1, 2025, pursuant to which the Chief Scientific Officer receives a gross monthly salary of NIS 51,750 ($14) in consideration for her services as Chief Scientific Officer of the Subsidiary. In addition, the Chief Scientific Officer is provided with a phone and a company car pursuant to the terms of her agreement.
President and Chief Executive Officer
Effective as of July 1, 2024, the Company entered into a consulting agreement with Shnida Ltd. (“Shnida”), whereby the Company’s President and Chief Executive Officer, through Shnida, provides services as President and Chief Executive Officer of the Company. The agreement is terminable by either party upon 140 days prior written notice. The agreement provides that Shnida will be reimbursed for reasonable expenses incurred in connection with performance of the agreement. Effective as of January 1, 2024, the President and Chief Executive Officer receives a monthly consulting fee of NIS 111,349 ($31). Pursuant to the agreement, Shnida and the President and Chief Executive Officer each agree that during the term of the agreement and for a 12-month period thereafter, none of them will compete with the Company nor solicit employees of the Company.
In addition, the Company, through the Subsidiary, has entered into an employment agreement with the President and Chief Executive Officer, effective as of July 1, 2024, pursuant to which, effective as of January 1, 2024, the President and Chief Executive Officer receives gross monthly salary of NIS 59,330 ($16) in consideration for his services as President and Chief Executive Officer of the Subsidiary. In addition, the President and Chief Executive Officer is provided with a phone and a company car pursuant to the terms of his agreement.
NOTE 13 - SUBSEQUENT EVENTS:
| a. | Alpha Tau |
On April 24, 2025, the Subsidiary entered into a share purchase agreement with Alpha Tau Medical Ltd. (Nasdaq: DRTS) (“Alpha Tau”), pursuant to which the Subsidiary purchased 14,110,121 (16.65%) ordinary shares, no par value per share, of Alpha Tau in a registered direct offering at a price of $2.612 per share, for an aggregate purchase price of approximately $36,900. The closing of the transaction occurred on April 28, 2025. In connection with the investment, the Subsidiary has the right to nominate two out of eight directors to Alpha Tau’s board of directors, subject to certain conditions.
Concurrently, the Subsidiary and Alpha Tau entered into a strategic investor relations and public relations services agreement, pursuant to which the Subsidiary will provide Alpha Tau with investor relations and public relations services. As consideration, Alpha Tau agreed to pay the Subsidiary a non-refundable fee of $3,000 over three years and to issue to the Subsidiary warrants to purchase up to 3,237,000 ordinary shares of Alpha Tau at exercise prices ranging from $3.474 to $3.90 per share, subject to shareholder approval. The term of the services agreement isthree years, with limited termination rights.
| b. | Scilex - Tranche B Note |
In April, 2025, and in accordance with Tranche B Note terms, the Company received from Scilex repayment of $3,722 ($3,125 of the principal amount and $597 accrued interest).
| c. | Real Estate – Castel |
In April 2025, the Company paid an additional $539 toward the acquisition price and $27 for related costs, thereby completing all required payments. As of May 14, 2025, the Company is in the process of transferring the rights of the real estate property and registering it under the Company’s name.
| d. | Loan Agreement |
In April 2025, the Company paid $27,650 in connection with the loans to Hapisga and to Tova Chocma (see note 7c).
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.