ORAMED PHARMACEUTICALS INC
For the period ended Mar 31, 2025. Filed May 15, 2025.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2025 · Filed May 15, 2025
ORMP$3.86-0.8%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2024-09-30; filed 2024-11-07.
0001213900-24-095397
ITEM 2. - MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-15.
0001213900-25-044193
ITEM 2. - MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 95 previous paragraphs and 97 current paragraphs.
24 unchanged; 26 reworded; 47 added; 43 removed; 2 previous and 0 current paragraphs rearranged.
Tables are not compared: 4 previous and 6 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (47)
Current report
On January 22, 2024, we along with our wholly-owned subsidiary Oramed Ltd., entered into a joint venture agreement with Hefei Tianhui Biotech Co., Ltd., or HTIT, and its subsidiary Technowl Limited, or HTIT Sub, to focus on developing and commercializing products based on our oral insulin and POD™ technology, utilizing HTIT’s manufacturing capabilities.
Current report
On February 7, 2025, we and HTIT entered into a Joint Venture Agreement, or the JV Agreement, amending the initial JV Agreement signed on January 22, 2024. To execute the JV Agreement, we formed OraTech Pharmaceuticals, Inc., or OraTech, which will serve as the joint venture entity. We currently hold 100% of OraTech shares. OraTech was formed to advance the development and commercialization of oral insulin, combining our proprietary technology and funding with HTIT’s manufacturing capabilities. Through this partnership, OraTech is expected to have the technology, resources, and production capacity to bring oral insulin to market. The agreement also outlines the spin-off of OraTech, or the Spin Off, requiring regulatory filings and the distribution of the majority of OraTech’s shares held by us to our shareholders. Both we and HTIT agreed to a 120-day lock-up period post-listing, restricting share sales.
Current report
Under the JV Agreement’s terms, the initial closing, or the Initial Closing, which was initially set as April 30, 2025 but has not yet occurred, will include an investment of $40,000,000 by HTIT and $7,500,000 by us into OraTech. Additionally, we will transfer all our intellectual property rights to OraTech. The second closing, which was initially set as to close by May 31, 2025, contingent on the listing of OraTech’s shares on Nasdaq, involves a $20,000,000 investment by HTIT and an additional $7,500,000 investment by us, or the Second Closing, which was initially set as to close by May 31, 2025. Upon completion of the Initial Closing and the Second Closing, OraTech will issue shares to both HTIT and us, resulting in ownership of 50% for each of HTIT and us, excluding the impact of the contemplated distribution of OraTech shares to our shareholders.
Current report
As part of the JV Agreement, HTIT will receive $20,000,000 at the Initial Closing and $10,000,000 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.
Current report
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.
Current report
As a result, the closing of the JV Agreement is currently on hold. Consequently, we paused plans to initiate the Phase 3 clinical trial in the U.S. pending further clarity. We are evaluating whether a modified structure with HTIT is feasible under current conditions and concurrently exploring alternative partners and pathways to advance the program independently.
Current report
2023 Scilex Transaction and 2024 Refinancing
Current report
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.
Current report
2024 Refinancing
Current report
Scilex received from us, in consideration for our part in Tranche B Notes and the Tranche B Warrants issued to us, an exchange and reduction of the principal outstanding balance under the Tranche A Note of $22,500,000.
Current report
As of May 14, 2025, we received a total amount of $3,722,000 from Scilex related to Tranche B Note.
Current report
Royalty Purchase Agreement
Current report
ZTlido Rest of the World Binding Agreement
Current report
To implement the agreement, we and the other institutional investors agreed to operate through a joint venture. Accordingly, on January 2, 2025, the institutional investors formed RoyaltyVest Ltd., or RoyaltyVest, a company incorporated in the British Virgin Islands. On February 12, 2025, they transferred to us 50% of the issued and outstanding shares of RoyaltyVest.
Current report
Tranche B Note Consent
Current report
On January 2, 2025, we and other Tranche B Noteholders entered into deferral and consent agreements with Scilex or the Tranche B Note Consent, deferring Scilex’s first amortization payment under the Tranche B Note to October 8, 2026. In consideration, we received approximately $877,000 and 71,249 shares of Scilex common stock.
Current report
In addition, as part of the Tranche B Consent and contingent upon certain conditions that were met:
Current report
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, we hold 350,000 shares of common stock of Scilex. In addition, as of March 31, 2025, we hold 187,715 Subsequent Penny Warrants.
Current report
Royalty Purchase Agreement — Gloperba and Elyxyb
Current report
Following the Tranche B Note Consent, on February 28, 2025, we entered into the RPA with the RPA Purchasers, pursuant to which Scilex Pharma sold rights to receive 4% of worldwide net sales of Gloperba, Elyxyb, and related products. We are entitled to 50% of these royalty payments. Under the agreement, Scilex Pharma will make quarterly payments to the RPA Purchasers for a term of 10 years, beginning with sales from the first quarter of 2025.
Current report
ZTLido License Agreement
Current report
Following the ROW License Term Sheet, on February 22, 2025, we, through our 50% ownership in RoyaltyVest, entered into a license agreement with Scilex, or the 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, in the ROW Territory. As part of the ZTLido License Agreement, RoyaltyVest and Scilex will each receive 50% of the net profits from the commercialization of these products. Given our 50% ownership in RoyaltyVest, we effectively hold a 25% in the profits generated under this agreement.
Current report
On February 28, 2025, we through 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, or 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.
Current report
BioXcel
Current report
In order to diversify our investments as a part of our use of cash strategy, on March 4, 2025, RoyaltyVest, participated in a registered direct offering by BioXcel Therapeutics, Inc. (Nasdaq: BTAI), or 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 $14,000,000. 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, are immediately exercisable with no expiration date.
Current report
BioXcel is a biopharmaceutical company leveraging artificial intelligence to develop innovative medicines in neuroscience and immuno-oncology. Its lead programs focus on treatments for agitation in neuropsychiatric disorders and other central nervous system conditions.
Current report
As of May 14, 2025, RoyaltyVest, have sold 1,739,988 shares and continue to hold 136,071 shares of BioXcel common stock and 2,123,941 pre-funded warrants.
Current report
Alpha Tau Transaction
Current report
On April 24, 2025, Oramed Ltd. entered into a share purchase agreement with Alpha Tau Medical Ltd. (Nasdaq: DRTS), or Alpha Tau, pursuant to which Oramed Ltd. purchased 14,110,121 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 $36,900,000. The closing of the transaction occurred on April 28, 2025. In connection with the investment, Oramed Ltd. has the right to nominate two directors to Alpha Tau’s board of directors, subject to certain conditions.
Current report
Concurrently, Oramed Ltd. and Alpha Tau entered into a strategic investor relations and public relations services agreement, pursuant to which Oramed Ltd. will provide Alpha Tau with investor relations and public relations services. As consideration, Alpha Tau agreed to pay Oramed Ltd. a non-refundable fee of $3,000,000 over three years and to issue to Oramed Ltd. 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 is three years, with limited termination rights.
Current report
Joint Venture Agreement: As mentioned above, on February 7, 2025, we entered into the JV Agreement with HTIT. The collaboration combines our POD technology with HTIT’s manufacturing capabilities. We expect this integration of technology and manufacturing expertise will enable us to ensure consistent, high-quality production at scale, setting new standards for oral protein delivery.
Current report
OraTech is backed by a substantial capital and operational commitment. These resources support the initiation of a Phase 3 clinical trial in the U.S. As mentioned above, by leveraging insights from prior clinical studies, we have strategically designed this refined Phase 3 trial to focus on key patient subpopulations that we believe have the highest potential to demonstrate efficacy.
Current report
In October 2022, Oravax reported positive preliminary Phase 1 data for Cohort A of a Phase 1 clinical trial, meeting primary or secondary endpoints of safety and immunogenicity. These results included significant antibody response (2-6 fold over baseline) as measured by multiple markers of immune response to virus like particle vaccine antigens observed in the majority of the patients dosed, and no safety issues were observed, including mild symptoms. Cohort B completed dosing in January 2023. Cohort B measured Immunoglobulin G, or IGG, against the spike (S) protein, showing positive IGG in approximately 55% of the patients dosed. We are currently evaluating our path forward for Oravax’s oral vaccines for COVID-19.
Current report
Real Estate Investments
Current report
On November 7, 2024, our Board of Directors, or the Board, approved investments of up to $10,000,000 in real estate assets. This decision aligns with our strategic approach to capital allocation, leveraging opportunities in the current real estate market where we have identified attractive investment prospects. With interest rates expected to decline and valuations presenting favorable entry points, the Board believes these investments could provide long-term value appreciation and potential income streams, further strengthening our financial position. As we continue to evaluate our business strategy, including potential structural changes, these investments are intended to enhance financial flexibility and maximize shareholder value. On February 13, 2025, the Board approved increasing the real estate investments to up to $30,000,000.
Current report
Real Estate Transactions
Current report
In January 2025, we entered into an agreement to acquire a parcel of land in Mevaseret Zion, Israel for a total purchase price of NIS 5,800,000 (approximately $1,586,000). The transaction is structured in installments, and as of May 14, 2025, we have paid approximately $1,221,000 toward the acquisition price.
Current report
On March 24, 2025, we 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 $22,650,000 (“Hapisga Loan”). The loan has 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 $800,000,000, providing significant collateral coverage. The loan bears an annual interest rate of 12%. On the same date, we entered into a loan agreement with Tova Chochma Im Nachala Ltd. (“Tova Chochama”) in the amount of $5,000,000. The loan bears an annual interest rate of 12% with a maturity date of 12 months. Tova Chochama can repay the loan at any time. This loan is also secured by the registration of the caveat for Hapisga Loan. The loans were granted by us in April 2025.
Current report
Comparison of three months ended March 31, 2025 and 2024
Current report
On February 7, 2025, we and HTIT entered into the JV Agreement, amending the original agreement signed on January 22, 2024. Pursuant to the terms of the JV Agreement, we and HTIT irrevocably released and waived (i) any claims and demands against each other party in connection with our existing Technology License Agreement with HTIT, or TLA; and (ii) all rights, obligations and liabilities set out and arising with respect to the performance of the TLA.
Showing the first 40 of 47 passages. Open the source sections for the rest.
Removed paragraphs (43)
Previous report
On August 30, 2024, Scilex agreed that 4,500,000 Closing Penny Warrants and 937,500 Subsequent Penny Warrants became exercisable as of such date.
Previous report
On September 20, 2024, we and Scilex entered into an extension agreement, or the Extension Agreement, to extend the due date of the September 21, 2024 payment under the Tranche A Note. Pursuant to the Extension Agreement, Scilex paid us $2,000,000 on September 23, 2024, which payment is to be applied as follows: (i) $1,700,000 to the payment due under the Tranche A Note on March 21, 2025 and (ii) $300,000 to purchase the Transferred Warrants. In addition, 1,062,500 Subsequent Penny Warrants were accelerated from December 15, 2024 and became exercisable into shares of Scilex common stock at any time after September 20, 2024.
Previous report
Scilex Refinancing
Previous report
Senior Convertible Notes
Previous report
The Tranche B Notes bear interest at a rate of 5.5% per annum, payable in arrears on the first trading day of each calendar quarter, beginning January 2, 2025, payable, at Scilex’s option, either in cash or in shares of Scilex common stock, subject to certain conditions. Unless earlier converted or redeemed, the Tranche B Note will mature on the two-year anniversary of the issuance date, subject to extension at the option of us in certain circumstances as provided in the Tranche B Note. The Tranche B Notes will be Scilex’s senior secured obligation (alongside and under certain circumstances subordinate to, the Tranche A Note) and will rank senior to the right to payment of the holders of Scilex’s subordinated debt and will be pari passu with all other indebtedness of Scilex.
Previous report
At any time after issuance, all amounts due under the Tranche B Notes are convertible, in whole or in part, and subject to certain beneficial ownership limitations, at our option, into Scilex common stock at the initial fixed conversion price of $1.09 per share, which is subject to adjustments provided that the conversion price cannot be lower than $1.04 unless Scilex shareholder approval is obtained. The Tranche B Notes may not be converted to the extent such conversion would result in our beneficially owning in excess of 4.99%, or the Maximum Percentage, of shares of the Scilex common stock outstanding immediately after giving effect to such conversion. At our option, the Maximum Percentage may be raised up to 9.99%, except that any increase will only be effective upon 61 days’ prior notice to Scilex.
Previous report
Scilex has the right (assuming no failure of certain specific conditions relating to Scilex’s equity) to redeem in cash all, but not less than all, of the amount then outstanding under the Tranche B Notes at a 35% redemption premium to the greater of (i) the amount then outstanding under the Tranche B Notes to be redeemed and (ii) the equity value of the Scilex common stock underlying such Tranche B Notes. Scilex has a mandatory obligation to redeem the Tranche B Notes upon an event of default relating to bankruptcy. The Tranche B Notes are subject to redemption at the election of each holder in certain circumstances, including, a change of control of Scilex, a subsequent placement of certain securities of Scilex, and asset sales by Scilex. The Tranche B Notes contain affirmative and negative covenants binding on Scilex and its subsidiaries and prohibit Scilex from entering into specified fundamental transactions unless the successor entity assumes all of Scilex’s obligations under the Tranche B Notes.
Previous report
The Tranche B Notes contain certain customary events of default, including, without limitation, a cross-default to other specified indebtedness or any other indebtedness involving an obligation of $5,000,000 or more. The interest rate of the Tranche B Notes will automatically increase to 15.0% per annum upon the occurrence and during the continuance of an event of default. Scilex is also required to pay a late charge of 15.0% on any amount of principal or other amounts that are not paid when due (solely to the extent such amounts are not then accruing interest at the default rate of 15.0% per annum).
Previous report
In connection with any amortization, certain redemptions or other repayment of the Tranche B Notes, Scilex will also pay an amount equal to the amount of additional interest that would accrue under such Tranche B Notes at the interest rate then in effect assuming that the amount so converted, redeemed, amortized or otherwise repaid on such date of determination instead remained outstanding through and including the maturity date of such Tranche B Notes.
Previous report
Scilex’s obligations under the Tranche A Note and Tranche B Notes are secured by a security interest in all or substantially all of the property of Scilex and each of its subsidiaries, respectively, pursuant to an amended and restated security agreement, or the Amended and Restated Security Agreement, with Scilex and its subsidiaries.
Previous report
Tranche B Warrants
Previous report
The Tranche B Warrants are exercisable for a period of five years from the date of issuance. The Tranche B Warrants issued to us at Closing will initially be exercisable for 3,750,000 shares of Scilex common stock, subject to the Maximum Percentage limitation.
Previous report
The Tranche B Warrants will initially be exercisable for cash at an exercise price equal to $1.09 per share of Scilex common stock, subject to adjustments upon the occurrence of any stock split, stock dividend, stock combination, recapitalization, similar transactions and/or full-ratchet adjustment in connection with a subsequent offering at a per share price less than the fixed conversion price then in effect subject to a floor price of $1.04 unless shareholder approval is obtained. If at the time of exercise, there is no effective registration statement registering the shares of Scilex common stock underlying the Tranche B Warrants, such warrants may be exercised on a cashless basis pursuant to their terms.
Previous report
Amendment to Scilex-Oramed SPA
Previous report
In connection with the execution of the Convertible Notes SPA, on October 8, 2024, we, Scilex and the Agent amended the Scilex-Oramed SPA to account for the issuance of the Tranche B Notes and the execution of certain related documents, including the Subordination Agreement (as defined herein) and an agreement, or the Agreement Among Holders, pursuant to which we and the Investors agreed that, subject to certain conditions and exceptions, the payment of the obligations in respect of the Tranche B Notes will be subject to the prior payment in full of all obligations in respect of the Tranche A Note up to the Maximum First Out Amount (as defined in the Agreement Among Holders).
Previous report
Royalty Transaction
Previous report
The Royalty Purchase Agreement terminates six months following receipt by the RPA Purchasers of all payments of the Purchased Receivables to which each RPA Purchaser is entitled thereunder during the period commencing on the date of closing and expiring on the tenth anniversary of such closing date.
Previous report
Pursuant to the terms of the Royalty Purchase Agreement, Scilex Pharma entered into a security agreement with the collateral agent (as identified therein) for the benefit of the RPA Purchasers, dated as of October 8, 2024, or the Royalty Security Agreement. Under the Royalty Security Agreement, Scilex’s and Scilex Pharma’s due performance and payment under the Royalty Purchase Agreement is secured by certain collateral, including a collection account and certain material contracts, intellectual property rights and the regulatory approvals, in each case related to the Covered Products. Scilex Pharma, the collateral agent and the Agent also entered into a subordination agreement, or the Subordination Agreement, whereby the parties agreed that all obligations, liabilities and indebtedness under the Royalty Purchase Agreement will be secured by first priority liens on the collateral under the Royalty Security Agreement, or the Royalty Collateral, and all obligations under the Amended and Restated Security Agreement, including in respect of the Tranche A Note and the Tranche B Notes, will be secured by second priority liens on the Royalty Collateral and first priority liens on all other collateral granted under the Amended and Restated Security Agreement.
Previous report
In consideration for the rights to be provided under the proposed Lido License Agreement, as more fully described in the ROW License Term Sheet, (a) Lido Dev Co. will invest (whether through cash consideration or in-kind payment through the provision of services) $200,000 per year toward expanding the Product, (b) Scilex will grant Lido Dev Co. 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, or the ROW Territory, and (c) each of Lido Dev Co. and Scilex will receive fifty percent of the net revenue (less expenses) generated from any Product in the ROW Territory.
Previous report
Scilex is required to use its commercially reasonable efforts to obtain the consent of Oishi and Itochu to the Lido License Agreement. If that consent is not obtained within 30 days of execution of the ROW License Term Sheet, Lido Dev Co. has the right to designate an agent to continue negotiations directly with Oishi and Itochu. Definitive documents for the Lido License Agreement and related matters are subject to ongoing negotiation among the parties thereto.
Previous report
Joint Venture Agreement: On January 22, 2024, Oramed and its wholly-owned subsidiary, Oramed Ltd., entered into a joint venture agreement, or the JV Agreement, with HTIT Biotech and Technowl Limited, a wholly-owned indirect subsidiary of HTIT Biotech and together with HTIT Biotech, HTIT, pursuant to which, subject to the terms and conditions set forth in the JV Agreement, the parties will establish a joint venture, or the JV, based on Oramed’s oral drug delivery technology.
Previous report
The JV will focus on the development and worldwide commercialization of innovative products based on Oramed’s oral insulin and POD™ (Protein Oral Delivery) pipeline and HTIT’s manufacturing capabilities and technologies. The JV expects to conduct a Phase 3 oral insulin clinical trial in the United States.
Previous report
Oramed and HTIT will initially hold equal shares in the JV, with each owning 50% of the equity. The board of directors will initially consist of equal representation from HTIT and Oramed. HTIT will contribute to the JV cash and credit to purchase materials, while Oramed will contribute cash and shares of Oramed common stock (that will be subject to certain registration rights) and will transfer intellectual property related to its oral insulin and POD™ technology, as well as other assets in the Oramed pipeline.
Previous report
The consummation of the JV Agreement is subject to and contingent upon the parties entering into additional agreements pursuant to the JV Agreement. There is no assurance that the parties will complete and sign these additional agreements.
Previous report
Comparison of nine and three month periods ended September 30, 2024 and September 30, 2023
Previous report
Revenues consist of proceeds related to the Amended and Restated Technology License Agreement, dated December 21, 2015, between us and HTIT, or as further amended by the parties on June 3, 2016 and July 24, 2016, the HTIT License Agreement, that are recognized on a cumulative basis when it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur, through the expected product submission date by HTIT of June 2023, using the input method.
Previous report
There were no revenues for the nine month period ended September 30, 2024 while revenues were $1,340,000 for the nine month period ended September 30, 2023. The decrease was due to recognition of revenues until the product submission date by HTIT of June 2023.
Previous report
Research and development expenses for the nine month period ended September 30, 2024 decreased by 33% to $4,863,000, compared to $7,205,000 for the nine month period ended September 30, 2023. The decrease was mainly due to lower expenses related to the Phase 3 trials that were terminated and was partially offset by higher stock-based compensation expenses.
Previous report
Research and development expenses for the three month period ended September 30, 2024 increased by 134% to $2,242,000, compared to $957,000 for the three month period ended September 30, 2023. The increase was due to costs related to the new Phase 3 clinical trial preparations.
Previous report
Government grants
Previous report
In the nine month periods ended September 30, 2024 and September 30, 2023, we did not receive any research and development grants. As of September 30, 2024, we had incurred liabilities to pay royalties to the Israel Innovation Authority of the Israeli Ministry of Economy and Industry of $59,000.
Previous report
Sales and Marketing Expenses
Previous report
We did not recognize any sales and marketing expenses for the nine month period ended September 30, 2024, compared to an income of $287,000 for the nine period ended September 30, 2023. The income primarily resulted from the reversal of previously recognized expenses related to forfeited employee stock options, following the termination of an executive officer in fiscal year 2023.
Previous report
We did not recognize any stock-based compensation expenses for the nine month period ended September 30, 2024, compared to an income of $440,000 for the nine month period ended September 30, 2023. The income primarily resulted from the reversal of previously recognized expenses related to forfeited employee stock options, following the termination of an executive officer in fiscal year 2023.
Previous report
We did not recognize any sales and marketing expenses for the three month periods ended September 30, 2024, compared to an income of $663,000 for the three month period ended September 30, 2023. The income primarily resulted from the reversal of previously recognized expenses related to forfeited employee stock options, following the termination of an executive officer in fiscal year 2023.
Previous report
General and administrative expenses for the nine month period ended September 30, 2024 decreased by 32% to $4,323,000 compared to $6,314,000 for the nine month period ended September 30, 2023. This decrease was mainly due to the reversal of previously recognized expenses following the resignation of certain executive officers.
Previous report
General and administrative expenses for the three month period ended September 30, 2024 decreased by 67% to $847,000 compared to $2,599,000 for the three month period ended September 30, 2023. This decrease was mainly due to the reversal of previously recognized expenses following the resignation of an executive officer.
Previous report
Interest expenses were $853,000 for the nine month period ended September 30, 2024, compared to $826,000 for the nine month period ended September 30, 2023. The increase was mainly due to interest on the Short-Term Borrowings (as defined below).
Previous report
Financial Income (Loss), Net
Previous report
Net financial income decreased by 14% to $3,902,000 for the nine month period ended September 30, 2024, compared to $4,510,000 for the nine month period ended September 30, 2023. The decrease was mainly due to the lower interest income on deposits.
Showing the first 40 of 43 passages. Open the source sections for the rest.
Reworded paragraphs (26)
Previous wording
We have developed an oral dosage form intended to withstand the harsh environment of the gastrointestinal tract and effectively deliver active insulin or other proteins. The formulation is not intended to modify the proteins chemically or biologically, and the dosage form is designed to be safe to ingest.
Current wording
We have developed an oral dosage form intended to withstand the harsh environment of the gastrointestinal tract and effectively deliver active insulin or other proteins. 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.
Previous wording
On September 21, 2023, we entered into and consummated the transactions, or, collectively, the 2023 Scilex Transaction, contemplated by a securities purchase agreement, or the Scilex-Oramed SPA, with Scilex Holding Company, or Scilex, pursuant to which Scilex issued to us:
Current wording
On September 21, 2023, we entered into and consummated transactions, or, collectively, the 2023 Scilex Transaction, with Scilex Holding Company, or Scilex, pursuant to which Scilex issued to us:
Previous wording
On October 7, 2024, we entered into a securities purchase agreement, or the Convertible Notes SPA, with certain institutional investors, or the Investors, and together with us, the Buyers, and Scilex, pursuant to which the Buyers purchased in a registered offering (i) a new tranche B of senior secured convertible notes of Scilex in the aggregate principal amount of $50,000,000, or the Tranche B Notes, which Tranche B Notes are convertible into shares of Scilex common stock and (ii) warrants, or the Tranche B Warrants, to purchase up to 7,500,000 shares of Scilex common stock. In the transaction, Scilex refinanced a portion of the Tranche A Note issued to us and paid off certain other indebtedness of Scilex. The transactions contemplated by the Convertible Notes SPA were consummated on October 8, 2024.
Current wording
On October 7, 2024, we and certain institutional investors, or the Note B Holders, entered into certain agreements with Scilex, pursuant to which the Note B Holders purchased in a registered offering, or the 2024 Refinancing, (i) a new tranche B of senior secured convertible notes of Scilex in the aggregate principal amount of $50,000,000, or the Tranche B Notes, which Tranche B Notes are convertible into shares of Scilex common stock and (ii) warrants, or the Tranche B Warrants, to purchase up to 214,286 shares of Scilex common stock with an exercise price of $1.04, or Tranche B Warrants. We purchased 50% of Tranche B Note and Tranche B Warrants and therefore hold an aggregate principal amount of $25,000,000 under the Tranche B Note and 107,143 Tranche B Warrants.
Previous wording
On October 8, 2024, we and certain institutional investors, or, collectively, the RPA Purchasers, entered into a Purchase and Sale Agreement, or the Royalty Purchase Agreement, with Scilex and Scilex Pharmaceuticals Inc., or Scilex Pharma. Pursuant to the Royalty Purchase Agreement, the RPA Purchasers acquired the right to receive, in the aggregate, 8.0% of net sales worldwide for 10 years, or 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, or the Covered Products. We have acquired the right to receive 50% of the Purchased Receivables, as more fully described in the Royalty Purchase Agreement.
Current wording
In addition to Tranche B Notes, on October 8, 2024, we and certain institutional investors, or the RPA Purchasers, entered into a Purchase and Sale Agreement, or the RPA, with Scilex and Scilex Pharmaceuticals Inc., or Scilex Pharma. Pursuant to the RPA, the RPA Purchasers acquired the right to receive, in the aggregate, 8% of net sales worldwide for 10 years of certain purchase receivables, or 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. We acquired the right to receive 50% of the Purchased Receivables, as more fully described in the RPA and therefore hold the right to receive 4% royalties.
Previous wording
In full consideration for the sale, transfer, conveyance and granting of the Purchased Receivables, and subject to the terms and conditions set forth in the Royalty Purchase Agreement, the aggregate purchase price paid by the RPA Purchasers for the Purchased Receivables was $5,000,000 (net of expenses of the RPA Purchasers). In consideration for our interest in the Purchased Receivables, we exchanged and reduced $2,500,000 of the principal balance under the Tranche A Note.
Current wording
In consideration for our interest in the Purchased Receivables, we exchanged and reduced $2,500,000 of the principal balance under the Tranche A Note.
Previous wording
The aggregate purchase price for the Tranche B Note issued to us and the related Tranche B Warrants was $22,500,000. The Tranche B Note issued to us bears an initial principal balance of $25,000,000 and an original issue discount of 10.0%. As consideration for the Tranche B Note and Tranche B Warrants, we exchanged a portion of the Tranche A Note resulting in a reduction of the principal outstanding balance under the Tranche A Note of $22,500,000. Additionally, Scilex used $12,500,000 of the net proceeds from the offering for the repayment and satisfaction of the outstanding balance under the Tranche A Note.
Current wording
Following the refinancing as described above, on October 8, 2024, Scilex used $12,500,000 of the net proceeds from the proceeds of the Tranche B Note for the repayment of the outstanding balance under the Tranche A Note.
Previous wording
On October 8, 2024, we, certain other institutional investors and Scilex entered into a binding term sheet, or the ROW License Term Sheet, regarding a license and development agreement, or the Lido License 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., or Oishi, and Itochu Chemical Frontier Corporation, or Itochu, as amended, and (ii) the associated Commercial Supply Agreement, dated February 16, 2017, between Scilex, Oishi and Itochu, as amended. Subject to determination of a final structure for the transactions contemplated by the ROW License Term Sheet, it is anticipated that we and such institutional investors will hold the Lido License Agreement through a joint venture, Lido Dev Co.
Current wording
We and certain other institutional investors and Scilex entered into a binding term sheet, or the 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. , or Oishi, and Itochu Chemical Frontier Corporation, or Itochu, as amended, and (ii) the associated commercial supply agreement, dated February 16, 2017, between Scilex, Oishi and Itochu, as amended.
Previous wording
Binding Term Sheet Regarding Rest of World License Agreement
Current wording
Gloperba Rest of World License Agreement
Previous wording
Type 2 Diabetes: We conducted the ORA-D-013-1 Phase 3 trial on patients with type 2 diabetes, or T2D, with inadequate glycaemic control who were on two or three oral glucose-lowering agents. The primary endpoint of the trial was to evaluate the efficacy of our oral insulin capsule, 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. On January 11, 2023, we announced that the ORA-D-013-1 Phase 3 trial did not meet its primary or secondary endpoints. Following the results of the ORA-D-013-1 Phase 3 trial, we also terminated the ORA-D-013-2 Phase 3 trial, a second Phase 3 trial that included T2D patients with inadequate glycaemic control who were attempting to manage their condition with either diet alone or with diet and metformin. In 2023, we 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 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, we have submitted a protocol for a new Phase 3 clinical trial to the FDA.
Current wording
Type 2 Diabetes: We conducted the ORA-D-013-1 Phase 3 trial on patients with type 2 diabetes, or T2D, with inadequate glycaemic control who were on two or three oral glucose-lowering agents. The primary endpoint of the trial was to evaluate the efficacy of our oral insulin capsule, 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. On January 11, 2023, we announced that the ORA-D-013-1 Phase 3 trial did not meet its primary or secondary endpoints. Following the results of the ORA-D-013-1 Phase 3 trial, we also terminated the ORA-D-013-2 Phase 3 trial, a second Phase 3 trial that included T2D patients with inadequate glycaemic control who were attempting to manage their condition with either diet alone or with diet and metformin. In 2023, we 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 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 we submitted a protocol for a revised Phase 3 (ORA-D-013-3) clinical trial to the FDA. We are additionally examining our existing pipeline and have commenced an evaluation process of potential strategic opportunities, with the goal of enhancing value for our stockholders.
Previous wording
On October 7, 2023, the State of Israel was attacked by and subsequently declared war on Hamas. Israel has been in an ongoing state of war with Hamas since that time. Following the attack by Hamas, Hezbollah has also launched attacks against Israel and Israel has been responding to these attacks with targeted air strikes. It is possible that other terrorist organizations, including Palestinian military organizations in the West Bank, as well as other hostile countries, will join the hostilities. As of November 7, 2024, we believe that there is no immediate risk to our business operations related to these events. For further information, see “Item 1A. Risk Factors,” under “We are affected by the political, economic and military risks of having operations in Israel” in our Annual Report.
Current wording
On October 7, 2023, the State of Israel was attacked by Hamas, a group designated as a terrorist organization by the United States, and the State of Israel subsequently declared war on Hamas. Since that time, Israel has been engaged in a multi-front armed conflict with combatants located in Gaza, the West Bank, Syria, Iran, Lebanon and Yemen. The situation in the region remains volatile and the possibility of renewed conflicts persists. As of May 14, 2025, we believe that there is no immediate risk to our business operations related to these events. For further information, see “Item 1A. Risk Factors,” under “We are affected by the political, economic and military risks of having operations in Israel” in our Annual Report.
Previous wording
On September 4, 2024, we entered into a loan agreement, or the Profit Sharing Loan Agreement, with Rabi Binyamin 4 Tama 38 Ltd., or the Borrower, to finance a real estate project, or the Project. According to the terms of the Profit Sharing Loan Agreement, we agreed to loan NIS 5.5 million ($1,523), or the Loan Principal, to the Borrower. NIS 4.7 million ($1,307) was loaned upon signing the Profit Sharing Loan Agreement and the remaining 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 we are 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.
Current wording
On September 4, 2024, we entered into a loan agreement, or the Profit Sharing Loan Agreement, with Rabi Binyamin 4 Tama 38 Ltd., or the Borrower, to finance a real estate project, or the Rabi Binyamin Project. According to the terms of the Profit Sharing Loan Agreement, we agreed to loan NIS 5,500,000 (approximately $1,523,000), or the Loan Principal, to the Borrower. NIS 4,700,000 (approximately $1,307,000) was loaned upon signing the Profit Sharing Loan Agreement and an additional NIS 800,000 (approximately $216,000) will be loaned upon certain milestones which are expected to occur in the first half of 2025. Upon completion of the Rabi Binyamin Project, we entitled to receive the Loan Principal and the greater of: (i) 20% annual interest of the Loan Principal and (ii) 40% of the Rabi Binyamin Project profits.
Previous wording
The following table summarizes certain statements of operations data of the Company for the nine and three month periods ended September 30, 2024 and September 30, 2023 (in thousands of dollars except share and per share data):
Current wording
The following table summarizes certain statements of operations data of the Company for the three months ended March 31, 2025 and 2024 (in thousands of dollars except share and per share data):
Previous wording
There were no revenues for the three month periods ended September 30, 2024 and 2023.
Current wording
We recognized $2,000,000 revenue related to the HTIT License Agreement in the three months ended March 31, 2025 while there were no revenues for the three months ended March 31, 2024.
Previous wording
There were no interest expenses for the three month period ended September 30, 2024, compared to interest expenses of $826,000 for the three month period ended September 30, 2023, since the Short-Term Borrowings (as defined below) received from Discount Bank Ltd. were terminated during the second quarter of 2024 (see below).
Current wording
There were no interest expenses for the three months ended March 31, 2025, compared to interest expenses of $592 for the three months ended March 31, 2024, since the Short-Term Borrowings (as defined below) received from Israel Discount Bank Ltd. were terminated during the second quarter of 2024.
Previous wording
Net financial loss was $15,420,000 for the three month period ended September 30, 2024, compared to $435,000 net financial income for the three month period ended September 30, 2023. The change was mainly due to the revaluation of the investments in Scilex.
Current wording
Net financial expenses were approximately $2,558,000 for the three months ended March 31, 2025, compared to financial income of approximately $5,088,000 for the three months ended March 31, 2024. The change was primarily due to the revaluation of the investment in Scilex, partially offset by interest income on deposits and the revaluation of marketable securities.
Previous wording
During the nine and three month periods ended September 30, 2024, we recognized tax expenses totaling $2,767,000 and $1,133,000, respectively. The tax expenses are primarily attributable to the 2023 Scilex Transaction. The provision for income taxes in the interim period is determined using an estimated annual effective tax rate (taking into account utilization of our carryforward tax losses).
Current wording
During the three months ended March 31, 2025, we recognized tax on income of approximately $584,000. The tax on income are primarily attributable to the 2023 Scilex Transaction and 2024 Refinancing. The provision for tax on income in the interim period is determined using an estimated annual effective tax rate.
Previous wording
During the three and nine month periods ended September 30, 2023, we did not recognize any tax expenses.
Current wording
During the three months ended March 31, 2024, we did not recognize any tax on income.
Previous wording
From inception through September 30, 2024, we have incurred losses in an aggregate amount of $166,427,000. During that period and through September 30, 2024, 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 $255,384,000, net of transaction costs. During that period, we also received cash consideration of $28,001,000 from the exercise of warrants and options. We expect to seek additional financing through similar sources in the future, as needed. As of September 30, 2024, we had $42,104,000 of available cash and $42,741,000 of short-term bank deposits.
Current wording
From our inception through March 31, 2025, we have incurred losses in an aggregate amount of approximately $184,258,000. During that period and through March 31, 2025, 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 approximately $255,384,000, net of transaction costs. During that period, we also received cash consideration of approximately $28,001,000 from the exercise of warrants and options. We expect to seek additional financing through similar sources in the future, as needed. As of March 31, 2025, we had approximately $74,516,000 of available cash and approximately $26,701,000 of short-term bank deposits. In addition, we hold a variety of interests in certain investments, including in Scilex and others, as further detailed in this Quarterly Report on Form 10-Q.
Previous wording
From inception through September 30, 2024, we have not generated significant revenues from our operations. Following the termination of the ORA-D-013-1 and ORA-D-013-2 Phase 3 trials, our research and development activities have been significantly reduced while it conducts a strategic review process. However, in the three month period ended September 30, 2024 we increased the research and development activities that related to the new Phase 3 clinical trial.
Current wording
From inception through March 31, 2025, we have not generated significant revenues from our operations (other than recognizing deferred revenue related to the HTIT License Agreement, as described above). Although, we have increased the research and development activities related to the new Phase 3 clinical trial, our research and development activities have been significantly reduced while we conducted a strategic review process, following the termination of the ORA-D-013-1 and ORA-D-013-2 Phase 3 trials. Following the preparation and expected initiation of the revised phase 3 trial (ORA-D-013-3), we expect to increase our research and development expenses, either directly or through OraTech.
Previous wording
As of September 30, 2024, our total current assets were $142,774,000 and our total current liabilities were $5,274,000. On September 30, 2024, we had a working capital surplus of $137,500,000 and an accumulated loss of $166,427,000. As of December 31, 2023, our total current assets were $162,584,000 and our total current liabilities were $53,214,000. On December 31, 2023, we had a working capital surplus of $109,370,000 and an accumulated loss of $157,556,000. The increase in working capital from December 31, 2023 to September 30, 2024 was mainly due to an increase in cash and cash equivalents and in investments at fair value, together with a decrease in short-term borrowings partially offset by a decrease in short-term deposits.
Current wording
As of March 31, 2025, our total current assets were approximately $131,476,000 and our total current liabilities were approximately $5,492,000. On March 31, 2025, we had a working capital surplus of approximately $125,984,000 and an accumulated loss of approximately $184,258,000. As of December 31, 2024, our total current assets were approximately $143,221,000 and our total current liabilities were approximately $5,685,000. On December 31, 2024, we had a working capital surplus of approximately $137,536,000 and an accumulated loss of approximately $176,616,000. The decrease in working capital surplus was mainly due a decrease in short-term deposits that was partially offset by an increase in cash and cash equivalents and marketable securities.
Previous wording
During the nine month period ended September 30, 2024, cash and cash equivalents increased to $42,104,000, from $9,055,000 as of December 31, 2023. The increase was mainly due to the reasons described below.
Current wording
During the three months ended March 31, 2025, cash and cash equivalents increased to approximately $74,516,000 from approximately $54,420,000 as of December 31, 2024. The increase was mainly due to the reasons described below.
Previous wording
Operating activities used cash of $6,500,000 in the nine month period ended September 30, 2024, compared to $8,877,000 used in the nine month period ended September 30, 2023. Cash used in operating activities primarily consisted research and development, general and administrative expenses, partially offset by interest received from short-term deposits, an increase in accounts payable and accrued expenses and stock based compensation.
Current wording
Operating activities used cash of approximately $3,519,000 in the three months ended March 31, 2025, compared to approximately $1,476,000 used in the three months ended March 31, 2024. Cash used in operating activities primarily consisted of research and development expenses, and general and administrative expenses, partially offset by interest received from short-term deposits and a slight increase in accounts payable and accrued expenses.
Previous wording
Investing activities provided cash of $90,393,000 in the nine month period ended September 30, 2024, compared to used cash of $103,035,000 in the nine month period ended September 30, 2023. Cash provided by investing activities in the nine month period ended September 30, 2024 consisted primarily of proceeds from short-term deposits and proceeds from long-term investments. Cash used by investing activities in the nine month period ended September 30, 2023 consisted primarily of the purchase of short-term deposits, partially offset by proceeds from short-term investing activities.
Current wording
Investing activities provided cash of approximately $23,616,000 in the three months ended March 31, 2025, compared to approximately $29,998,000 in the three months ended March 31, 2024. Cash provided by investing activities in the three months ended March 31, 2025 consisted primarily of proceeds from short-term deposits and proceeds from the sale of BioXcel shares by RoyaltyVest. Cash provided by investing activities in the three months ended March 31, 2024 is mainly due to our investment in Scilex and short-term investing activities, partially offset by the purchase of short-term deposits.
Previous wording
Financing activities used cash of $50,842,000 in the nine month period ended September 30, 2024, compared to cash of $76,978,000 provided in the nine month period ended September 30, 2023. Cash used by financing activities in the nine month period ended September 30, 2024, consisted primarily of repayments of the Short-Term Borrowings and repurchases of our shares. Cash provided by financing activities in the nine month period ended September 30, 2023, consisted primarily of proceeds from the issuance of our common stock.
Current wording
There were no financing activities in the three months ended March 31, 2025, compared to cash used by financing activities of approximately $19,000,000 in the three months ended March 31, 2024. Cash used by financing activities in the three months ended March 31, 2024, consisted primarily of partial repayment of the Short-Term Borrowings described below.
Previous wording
On August 8, 2023, we borrowed an aggregate of $99,550,000 pursuant to Loan agreements from Israel Discount Bank Ltd., or the Short-Term Borrowings. The Short-Term Borrowings matured on dates ranging from August 11, 2023 to May 24, 2024, bore interest ranging from 6.66% to 7.38%, were secured by certificates of deposits issued by Israel Discount Bank Ltd. having an aggregate face amount of $99,550,000. The net proceeds of the Short-Term Borrowings were used to fund the Tranche A Note. The Short-Term Borrowings were paid in one payment of principal and interest at each respective maturity. As of September 30, 2024, we repaid the entire Short-Term Borrowings amount.
Current wording
On August 8, 2023, we borrowed an aggregate of $99,550,000 pursuant to loan agreements from Israel Discount Bank Ltd., or the Short-Term Borrowings. The Short-Term Borrowings matured on dates ranging from August 11, 2023 to May 24, 2024, bore interest ranging from 6.66% to 7.38%, were secured by certificates of deposits issued by Israel Discount Bank Ltd. having an aggregate face amount of $99,550,000. The net proceeds of the Short-Term Borrowings were used to fund the Tranche A Note. The Short-Term Borrowings were paid in one payment of principal and interest at each respective maturity. As of March 31, 2025, we had repaid the entire Short-Term Borrowings amount.
Previous wording
We have invested 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.
Current wording
In previous years, we primarily invested in research and development. We expect that in the upcoming years our research and development expenses will continue to be our major operating expense, either directly or under the JV Agreement, however, if this clinical trial is conducted through OraTech, these costs will be borne by OraTech and not by us.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
On January 11, 2023, we announced that the Phase 3 oral insulin trial (ORA-D-013-1) did not meet its primary or secondary endpoints. As a result, we terminated this trial and a parallel Phase 3, ORA-D-013-2 clinical trial. In 2023, we completed an analysis of the ORA-D-013-1 Phase 3 trial data 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. Based on this analysis, we have submitted a protocol for a new Phase 3 clinical trial to the FDA. We are additionally examining our existing pipeline and have commenced an evaluation process of potential strategic opportunities, with the goal of enhancing value for our stockholders.
Previous report — wording carried elsewhere
Sales and marketing expenses include the salaries and related expenses of our commercial functions, consulting expenses and other general expenses.