[10-Q] Oramed Pharmaceuticals Inc. Quarterly Earnings Report
Oramed Pharmaceuticals, Inc. reports condensed consolidated interim results and disclosures for the quarter ended June 30, 2025. The company operates in a single reportable segment focused on research and development of orally delivered pharmaceuticals and vaccines. The filing details multiple strategic investments and financing arrangements, including a $36,900 investment in Alpha Tau Medical (yielding an unrealized gain of $7,138 recognized in the six months ended June 30, 2025), equity method accounting for a 50% interest in RoyaltyVest, and various loans and real estate investments presented at fair value.
The company continues to hold structured receivables and convertible notes related to Scilex, including Tranche A and Tranche B Notes, and warrants (including 6,500,000 Subsequent Penny Warrants) with monetization restrictions; as of June 30, 2025 Scilex had repaid $69,200 of the Tranche A Note. The company entered an Option Agreement (July 22, 2025) under which Scilex may repurchase Subsequent Penny Warrants for a total of $27,000, and the agreement could extend the Tranche A Note maturity if completed. The company discloses deferred revenue recognition related to an HTIT license arrangement and describes cash flows, fair value measurements, share-based compensation grants (PSUs/RSUs), and a limited stock repurchase program under which 163,869 shares were repurchased for $371.
Oramed Pharmaceuticals, Inc. presenta risultati consolidati abbreviati e informazioni intermedie per il trimestre chiuso il 30 giugno 2025. L'azienda opera in un unico segmento riferibile, dedicato alla ricerca e sviluppo di farmaci e vaccini somministrabili per via orale. La relazione evidenzia diversi investimenti strategici e operazioni di finanziamento, incluso un investimento di $36.900 in Alpha Tau Medical (con un guadagno non realizzato di $7.138 rilevato nei sei mesi terminati il 30 giugno 2025), l'applicazione del metodo del patrimonio netto per una partecipazione del 50% in RoyaltyVest e vari prestiti e investimenti immobiliari valutati al fair value.
L'azienda mantiene crediti strutturati e cambiali convertibili collegati a Scilex, comprese le Note Tranche A e Tranche B, e warrant (inclusi 6.500.000 Subsequent Penny Warrants) con restrizioni di monetizzazione; al 30 giugno 2025 Scilex aveva rimborsato $69.200 della Tranche A Note. La società ha stipulato un Accordo di Opzione (22 luglio 2025) in base al quale Scilex può riacquistare i Subsequent Penny Warrants per un totale di $27.000, e l'accordo potrebbe estendere la scadenza della Tranche A Note se completato. Viene inoltre comunicato il differimento del riconoscimento dei ricavi relativo a un accordo di licenza HTIT e descritte le attività di cassa, le misurazioni a fair value, le assegnazioni di compensi azionari (PSU/RSU) e un programma limitato di riacquisto azionario per il quale sono state riacquistate 163.869 azioni per $371.
Oramed Pharmaceuticals, Inc. informa resultados condensados consolidados e información intermedia correspondientes al trimestre terminado el 30 de junio de 2025. La compañía opera en un único segmento informable centrado en la investigación y desarrollo de medicamentos y vacunas administrados por vía oral. La presentación detalla varias inversiones estratégicas y acuerdos de financiación, incluyendo una inversión de $36.900 en Alpha Tau Medical (que generó una ganancia no realizada de $7.138 reconocida en los seis meses terminados el 30 de junio de 2025), la contabilización por el método de la participación por un interés del 50% en RoyaltyVest, y diversos préstamos e inversiones inmobiliarias presentados a valor razonable.
La compañía mantiene cuentas por cobrar estructuradas y pagarés convertibles relacionados con Scilex, incluidas las Notas Tranche A y Tranche B, y warrants (incluyendo 6.500.000 Subsequent Penny Warrants) con restricciones de monetización; al 30 de junio de 2025 Scilex había reembolsado $69.200 de la Tranche A Note. La empresa suscribió un Acuerdo de Opción (22 de julio de 2025) por el cual Scilex puede recomprar los Subsequent Penny Warrants por un total de $27.000, y el acuerdo podría prorrogar el vencimiento de la Tranche A Note si se concreta. Se revela además el diferimiento del reconocimiento de ingresos relacionado con un acuerdo de licencia HTIT y se describen los flujos de efectivo, las mediciones a valor razonable, las concesiones de compensación basada en acciones (PSU/RSU) y un programa limitado de recompra de acciones bajo el cual se recompraron 163.869 acciones por $371.
Oramed Pharmaceuticals, Inc.는 2025년 6월 30일로 종료된 분기 동안의 요약 연결 중간 재무결과 및 공시를 보고합니다. 회사는 경구 투여형 의약품 및 백신의 연구개발에 집중하는 단일 보고 세그먼트로 운영됩니다. 제출 자료에는 Alpha Tau Medical에 대한 $36,900 투자(2025년 6월 30일로 종료된 6개월 동안 인식된 미실현 이익 $7,138 포함), RoyaltyVest 지분 50%에 대한 지분법 회계 적용, 공정가치로 표시된 다양한 대출 및 부동산 투자가 상세히 기재되어 있습니다.
회사는 Scilex 관련 구조화 매출채권 및 전환사채를 보유하고 있으며, Tranche A 및 Tranche B 노트와 매출 제한이 있는 워런트(6,500,000 Subsequent Penny Warrants 포함)가 포함됩니다; 2025년 6월 30일 기준 Scilex는 Tranche A Note 중 $69,200를 상환했습니다. 회사는 Scilex가 총 $27,000에 Subsequent Penny Warrants를 재매입할 수 있는 옵션 계약(2025년 7월 22일)을 체결했으며, 이 계약이 완료되면 Tranche A Note의 만기가 연장될 수 있습니다. 또한 HTIT 라이선스 계약과 관련된 수익 인식 이연, 현금흐름, 공정가치 측정, 주식 기반 보상(PSU/RSU) 부여 및 163,869주를 $371에 재매입한 제한적 자사주 매입 프로그램을 공개하고 있습니다.
Oramed Pharmaceuticals, Inc. publie des résultats consolidés intermédiaires abrégés et des informations pour le trimestre clos le 30 juin 2025. La société opère dans un seul secteur identifiable, axé sur la recherche et le développement de médicaments et vaccins administrés par voie orale. le dépôt détaille plusieurs investissements stratégiques et arrangements de financement, y compris un investissement de $36 900 dans Alpha Tau Medical (dégageant un gain non réalisé de $7 138 reconnu au cours des six mois clos le 30 juin 2025), la comptabilisation selon la méthode de mise en équivalence pour une participation de 50% dans RoyaltyVest, ainsi que divers prêts et investissements immobiliers présentés à la juste valeur.
La société détient des créances structurées et des billets convertibles liés à Scilex, incluant les billets Tranche A et Tranche B, et des warrants (dont 6 500 000 Subsequent Penny Warrants) soumis à des restrictions de monétisation ; au 30 juin 2025, Scilex avait remboursé $69 200 de la Tranche A Note. La société a conclu un accord d'option (22 juillet 2025) par lequel Scilex peut racheter les Subsequent Penny Warrants pour un total de $27 000, et l'accord pourrait prolonger l'échéance de la Tranche A Note s'il est exécuté. Sont également divulgués le différé de reconnaissance des revenus lié à un contrat de licence HTIT, ainsi que les flux de trésorerie, les mesures à la juste valeur, les attributions de rémunération en actions (PSU/RSU) et un programme limité de rachat d'actions dans le cadre duquel 163 869 actions ont été rachetées pour $371.
Oramed Pharmaceuticals, Inc. legt die verkürzten konsolidierten Zwischenabschlüsse und Angaben für das Quartal zum 30. Juni 2025 vor. Das Unternehmen ist in einem berichtspflichtigen Segment tätig, das sich auf Forschung und Entwicklung von oral verabreichten Arzneimitteln und Impfstoffen konzentriert. Die Einreichung beschreibt mehrere strategische Investitionen und Finanzierungsvereinbarungen, darunter eine Investition von $36.900 in Alpha Tau Medical (mit einem in den sechs Monaten bis zum 30. Juni 2025 ausgewiesenen nicht realisierten Gewinn von $7.138), die Equity-Methode für eine 50%-Beteiligung an RoyaltyVest sowie verschiedene Darlehen und Immobilieninvestitionen zum Fair Value.
Das Unternehmen hält strukturierte Forderungen und wandelbare Schuldverschreibungen im Zusammenhang mit Scilex, einschließlich Tranche A- und Tranche B-Notes, sowie Warrants (einschließlich 6.500.000 Subsequent Penny Warrants) mit Monetarisierungseinschränkungen; zum 30. Juni 2025 hatte Scilex $69.200 der Tranche A Note zurückgezahlt. Das Unternehmen hat eine Optionsvereinbarung (22. Juli 2025) getroffen, wonach Scilex die Subsequent Penny Warrants insgesamt für $27.000 zurückkaufen kann, und die Vereinbarung könnte die Fälligkeit der Tranche A Note im Erfolgsfall verlängern. Ferner wird die zeitliche Abgrenzung der Erlöserfassung im Zusammenhang mit einer HTIT-Lizenzvereinbarung offengelegt sowie Cashflows, Fair-Value-Messungen, aktienbasierte Vergütungszuteilungen (PSU/RSU) und ein begrenztes Aktienrückkaufprogramm, bei dem 163.869 Aktien für $371 zurückgekauft wurden, beschrieben.
- Unrealized gain of $7,138 recognized on the Alpha Tau investment during the six months ended June 30, 2025.
- $36,900 investment in Alpha Tau completed, providing a significant equity stake and board nomination rights.
- $69,200 repaid by Scilex toward the Tranche A Note as of June 30, 2025, reducing outstanding exposure.
- Option Agreement with Scilex allows potential repurchase of Subsequent Penny Warrants for a total of $27,000, offering a defined monetization path.
- 163,869 shares repurchased under the buyback program for $371, demonstrating active capital-return actions (program not obligating future purchases).
- Substantial exposure to Scilex-related instruments (Tranche A/B Notes, multiple warrant classes) with monetization restrictions and Level 3 fair value inputs.
- Monetization constraints on 6,500,000 Subsequent Penny Warrants due to Nasdaq and other restrictions, limiting near-term liquidity from those warrants.
- Reliance on counterparty performance for realization of value (e.g., Scilex repayments, RoyaltyVest exercises, HTIT JV completion).
- Valuation sensitivity noted: the company used unobservable inputs and scenario-based techniques for fair value measurement, increasing estimation risk.
Insights
TL;DR: Oramed shows active balance sheet management through investments and structured financings but remains exposed to counterparty and monetization constraints.
Oramed's filings disclose material non-operating activity: a large equity stake in Alpha Tau (purchase price $36,900) with a reported unrealized gain of $7,138, and complex financings with Scilex involving Tranche A/B notes, multiple warrant classes and a subsequent Option Agreement that could monetize warrants for $27,000. The company reports receipt of $69,200 toward Tranche A repayments as of June 30, 2025, but also emphasizes monetization restrictions on the 6,500,000 Subsequent Penny Warrants and valuation adjustments under Level 3 inputs. These items indicate liquidity and valuation sensitivity to counterparty performance and market restrictions, while share repurchases (163,869 shares for $371) and equity-method interests (RoyaltyVest 50%) show attempts to redeploy capital.
TL;DR: The company is pursuing strategic partnerships and equity investments but relies on contingent monetization and complex royalty/convertible structures.
Oramed's contractual arrangements are notable: a JV with HTIT to form OraTech with planned cash contributions and IP transfers, significant royalty purchase and assignment arrangements tied to Scilex product rights, and an Option Agreement allowing Scilex to repurchase warrants in two tranches for $27,000. The filings show active use of convertible notes, royalty-sharing vehicles (RoyaltyVest) and equity stakes (Alpha Tau, BioXcel-related activity). For investors, these are structurally complex, with value realization dependent on counterparty execution, regulatory/market outcomes for underlying assets, and fair-value assumptions (including Level 3 inputs) used in valuations.
Oramed Pharmaceuticals, Inc. presenta risultati consolidati abbreviati e informazioni intermedie per il trimestre chiuso il 30 giugno 2025. L'azienda opera in un unico segmento riferibile, dedicato alla ricerca e sviluppo di farmaci e vaccini somministrabili per via orale. La relazione evidenzia diversi investimenti strategici e operazioni di finanziamento, incluso un investimento di $36.900 in Alpha Tau Medical (con un guadagno non realizzato di $7.138 rilevato nei sei mesi terminati il 30 giugno 2025), l'applicazione del metodo del patrimonio netto per una partecipazione del 50% in RoyaltyVest e vari prestiti e investimenti immobiliari valutati al fair value.
L'azienda mantiene crediti strutturati e cambiali convertibili collegati a Scilex, comprese le Note Tranche A e Tranche B, e warrant (inclusi 6.500.000 Subsequent Penny Warrants) con restrizioni di monetizzazione; al 30 giugno 2025 Scilex aveva rimborsato $69.200 della Tranche A Note. La società ha stipulato un Accordo di Opzione (22 luglio 2025) in base al quale Scilex può riacquistare i Subsequent Penny Warrants per un totale di $27.000, e l'accordo potrebbe estendere la scadenza della Tranche A Note se completato. Viene inoltre comunicato il differimento del riconoscimento dei ricavi relativo a un accordo di licenza HTIT e descritte le attività di cassa, le misurazioni a fair value, le assegnazioni di compensi azionari (PSU/RSU) e un programma limitato di riacquisto azionario per il quale sono state riacquistate 163.869 azioni per $371.
Oramed Pharmaceuticals, Inc. informa resultados condensados consolidados e información intermedia correspondientes al trimestre terminado el 30 de junio de 2025. La compañía opera en un único segmento informable centrado en la investigación y desarrollo de medicamentos y vacunas administrados por vía oral. La presentación detalla varias inversiones estratégicas y acuerdos de financiación, incluyendo una inversión de $36.900 en Alpha Tau Medical (que generó una ganancia no realizada de $7.138 reconocida en los seis meses terminados el 30 de junio de 2025), la contabilización por el método de la participación por un interés del 50% en RoyaltyVest, y diversos préstamos e inversiones inmobiliarias presentados a valor razonable.
La compañía mantiene cuentas por cobrar estructuradas y pagarés convertibles relacionados con Scilex, incluidas las Notas Tranche A y Tranche B, y warrants (incluyendo 6.500.000 Subsequent Penny Warrants) con restricciones de monetización; al 30 de junio de 2025 Scilex había reembolsado $69.200 de la Tranche A Note. La empresa suscribió un Acuerdo de Opción (22 de julio de 2025) por el cual Scilex puede recomprar los Subsequent Penny Warrants por un total de $27.000, y el acuerdo podría prorrogar el vencimiento de la Tranche A Note si se concreta. Se revela además el diferimiento del reconocimiento de ingresos relacionado con un acuerdo de licencia HTIT y se describen los flujos de efectivo, las mediciones a valor razonable, las concesiones de compensación basada en acciones (PSU/RSU) y un programa limitado de recompra de acciones bajo el cual se recompraron 163.869 acciones por $371.
Oramed Pharmaceuticals, Inc.는 2025년 6월 30일로 종료된 분기 동안의 요약 연결 중간 재무결과 및 공시를 보고합니다. 회사는 경구 투여형 의약품 및 백신의 연구개발에 집중하는 단일 보고 세그먼트로 운영됩니다. 제출 자료에는 Alpha Tau Medical에 대한 $36,900 투자(2025년 6월 30일로 종료된 6개월 동안 인식된 미실현 이익 $7,138 포함), RoyaltyVest 지분 50%에 대한 지분법 회계 적용, 공정가치로 표시된 다양한 대출 및 부동산 투자가 상세히 기재되어 있습니다.
회사는 Scilex 관련 구조화 매출채권 및 전환사채를 보유하고 있으며, Tranche A 및 Tranche B 노트와 매출 제한이 있는 워런트(6,500,000 Subsequent Penny Warrants 포함)가 포함됩니다; 2025년 6월 30일 기준 Scilex는 Tranche A Note 중 $69,200를 상환했습니다. 회사는 Scilex가 총 $27,000에 Subsequent Penny Warrants를 재매입할 수 있는 옵션 계약(2025년 7월 22일)을 체결했으며, 이 계약이 완료되면 Tranche A Note의 만기가 연장될 수 있습니다. 또한 HTIT 라이선스 계약과 관련된 수익 인식 이연, 현금흐름, 공정가치 측정, 주식 기반 보상(PSU/RSU) 부여 및 163,869주를 $371에 재매입한 제한적 자사주 매입 프로그램을 공개하고 있습니다.
Oramed Pharmaceuticals, Inc. publie des résultats consolidés intermédiaires abrégés et des informations pour le trimestre clos le 30 juin 2025. La société opère dans un seul secteur identifiable, axé sur la recherche et le développement de médicaments et vaccins administrés par voie orale. le dépôt détaille plusieurs investissements stratégiques et arrangements de financement, y compris un investissement de $36 900 dans Alpha Tau Medical (dégageant un gain non réalisé de $7 138 reconnu au cours des six mois clos le 30 juin 2025), la comptabilisation selon la méthode de mise en équivalence pour une participation de 50% dans RoyaltyVest, ainsi que divers prêts et investissements immobiliers présentés à la juste valeur.
La société détient des créances structurées et des billets convertibles liés à Scilex, incluant les billets Tranche A et Tranche B, et des warrants (dont 6 500 000 Subsequent Penny Warrants) soumis à des restrictions de monétisation ; au 30 juin 2025, Scilex avait remboursé $69 200 de la Tranche A Note. La société a conclu un accord d'option (22 juillet 2025) par lequel Scilex peut racheter les Subsequent Penny Warrants pour un total de $27 000, et l'accord pourrait prolonger l'échéance de la Tranche A Note s'il est exécuté. Sont également divulgués le différé de reconnaissance des revenus lié à un contrat de licence HTIT, ainsi que les flux de trésorerie, les mesures à la juste valeur, les attributions de rémunération en actions (PSU/RSU) et un programme limité de rachat d'actions dans le cadre duquel 163 869 actions ont été rachetées pour $371.
Oramed Pharmaceuticals, Inc. legt die verkürzten konsolidierten Zwischenabschlüsse und Angaben für das Quartal zum 30. Juni 2025 vor. Das Unternehmen ist in einem berichtspflichtigen Segment tätig, das sich auf Forschung und Entwicklung von oral verabreichten Arzneimitteln und Impfstoffen konzentriert. Die Einreichung beschreibt mehrere strategische Investitionen und Finanzierungsvereinbarungen, darunter eine Investition von $36.900 in Alpha Tau Medical (mit einem in den sechs Monaten bis zum 30. Juni 2025 ausgewiesenen nicht realisierten Gewinn von $7.138), die Equity-Methode für eine 50%-Beteiligung an RoyaltyVest sowie verschiedene Darlehen und Immobilieninvestitionen zum Fair Value.
Das Unternehmen hält strukturierte Forderungen und wandelbare Schuldverschreibungen im Zusammenhang mit Scilex, einschließlich Tranche A- und Tranche B-Notes, sowie Warrants (einschließlich 6.500.000 Subsequent Penny Warrants) mit Monetarisierungseinschränkungen; zum 30. Juni 2025 hatte Scilex $69.200 der Tranche A Note zurückgezahlt. Das Unternehmen hat eine Optionsvereinbarung (22. Juli 2025) getroffen, wonach Scilex die Subsequent Penny Warrants insgesamt für $27.000 zurückkaufen kann, und die Vereinbarung könnte die Fälligkeit der Tranche A Note im Erfolgsfall verlängern. Ferner wird die zeitliche Abgrenzung der Erlöserfassung im Zusammenhang mit einer HTIT-Lizenzvereinbarung offengelegt sowie Cashflows, Fair-Value-Messungen, aktienbasierte Vergütungszuteilungen (PSU/RSU) und ein begrenztes Aktienrückkaufprogramm, bei dem 163.869 Aktien für $371 zurückgekauft wurden, beschrieben.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
For the quarterly period ended
Commission file number:
(Exact Name of Registrant as Specified in Its Charter)
(State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification No.) | |
(Address of Principal Executive Offices) | (Zip Code) |
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each class | Trading symbol | Name of each exchange on which registered | ||
The Tel Aviv Stock Exchange |
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer | ☐ | Accelerated filer | ☐ |
☒ | Smaller reporting company | ||
Emerging growth company |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ☐ No
As of August 12, 2025, there were
ORAMED PHARMACEUTICALS INC.
FORM 10-Q
TABLE OF CONTENTS
PART I - FINANCIAL INFORMATION | 1 | ||
ITEM 1 - FINANCIAL STATEMENTS | 1 | ||
ITEM 2 - MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS | 29 | ||
ITEM 3 - QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK | 37 | ||
ITEM 4 - CONTROLS AND PROCEDURES | 37 | ||
PART II - OTHER INFORMATION | 38 | ||
ITEM 1A - RISK FACTORS | 38 | ||
ITEM 2 - UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS | 38 | ||
ITEM 6 - EXHIBITS | 39 |
As used in this Quarterly Report on Form 10-Q, the terms “we,” “us,” “our,” “Oramed” and the “Company” mean Oramed Pharmaceuticals Inc. and our wholly-owned subsidiaries, unless otherwise indicated. All dollar amounts refer to U.S. Dollars unless otherwise indicated.
On June 30, 2025, the exchange rate between the New Israeli Shekel, or NIS, and the dollar, as quoted by the Bank of Israel, was NIS 3.372 to $1.00. Unless indicated otherwise by the context, statements in this Quarterly Report on Form 10-Q that provide the dollar equivalent of NIS amounts or provide the NIS equivalent of dollar amounts are based on such exchange rate.
i
Cautionary Statement Regarding Forward-Looking Statements
The statements contained in this Quarterly Report on Form 10-Q that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws and the Israeli securities law. Words such as “expects,” “anticipates,” “intends,” “plans,” “planned expenditures,” “believes,” “seeks,” “estimates,” “considers” and similar expressions or variations of such words are intended to identify forward-looking statements, but are not deemed to represent an all-inclusive means of identifying forward-looking statements as denoted in this Quarterly Report on Form 10-Q. Additionally, statements concerning future matters are forward-looking statements. We remind readers that forward-looking statements are merely predictions and therefore inherently subject to uncertainties and other factors and involve known and unknown risks that could cause the actual results, performance, levels of activity, or our achievements, or industry results, to be materially different from any future results, performance, levels of activity, or our achievements, or industry results, expressed or implied by such forward-looking statements. Such forward-looking statements include, among other statements, statements regarding the following:
● | our plan to evaluate potential strategic opportunities; |
● | our potential repurchases of shares of our common stock; |
● | our ability to recover the proceeds and/or collateral under the Tranche A Note and Tranche B Note (as defined herein) and related agreements from Scilex Holding Company, or Scilex; |
● | the fluctuating market price and liquidity of the common stock of Scilex underlying the warrants we hold; |
● | the possibility that the anticipated benefits of the 2023 Scilex Transaction and 2024 Refinancing (each as defined herein) are not realized when expected or at all, including as a result of the impact of, or problems arising from, the ability of Scilex to repay the Tranche A Note and Tranche B Note (each as defined herein), and the ability of the Company to realize the value of the warrants; |
● | our ability to complete the joint venture agreement, or the JV Agreement, with Hefei Tianhui Biotech Co., Ltd., or HTIT, in Oramed NewCo, Inc., or OraTech, and the potential spin off of OraTech, or the Spin Off, without delay or at all and the impact of the Spin Off on our financial position, operations, and ability to realize anticipated benefits from our joint venture; |
● | tariffs imposed on all imports into the United States from China may affect our joint venture with HTIT; |
● | our loan agreement in real estate projects, including, but not limited to finance a real estate project, or Profit Sharing Loan Agreement, expose us to potential market, liquidity, and execution risks; |
● | our various real estate and other investments, including, but not limited to Alpha Tau Medical Ltd., a clinical-stage company, involve significant risks and might not provide long-term value appreciation and potential income streams that we expect to receive; as we continue to evaluate our business strategy, including potential structural changes, these investments are intended to enhance financial flexibility and maximize shareholder value. For example, if Alpha Tau fails to achieve positive clinical results or obtain regulatory approvals, the value of our investment could decline materially, which may adversely affect our financial results; |
● | our exposure to potential litigation; |
● | our ability to enhance value for our stockholders; |
● | the expected development and potential benefits from our products; |
● | the prospects of entering into additional license agreements, or other partnerships or forms of cooperation with other companies or medical institutions; |
● | future milestones, conditions and royalties under our license agreements; |
● | the potential of the Oravax Medical Inc., or Oravax, vaccine to protect against the coronavirus; |
● | our research and development plans, including preclinical and clinical trials plans and the timing of enrollment, obtaining results and conclusion of trials; |
ii
● | our belief that our technology has the potential to deliver medications and vaccines orally that today can only be delivered via injection; |
● | the competitive ability of our technology based on product efficacy, safety, patient convenience, reliability, value and patent position; |
● | the potential market demand for our products; |
● | our ability to obtain patent protection for our intellectual property; |
● | our expectation that our research and development expenses will continue to be our major expenditure; |
● | our expectations regarding our short- and long-term capital requirements; |
● | our outlook for the coming months and future periods, including but not limited to our expectations regarding future revenue and expenses; and |
● | information with respect to any other plans and strategies for our business. |
Although forward-looking statements in this Quarterly Report on Form 10-Q reflect the good faith judgment of our management, such statements can only be based on facts and factors currently known by us. Consequently, forward-looking statements are inherently subject to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or anticipated by the forward-looking statements. Factors that could cause or contribute to such differences in results and outcomes include, without limitation, those specifically addressed under the heading “Item 1A. Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended December 31, 2024, or our Annual Report, as filed with the Securities and Exchange Commission, or the SEC, on March 27, 2025, as amended on July 16, 2025, as well as those discussed elsewhere in our Annual Report and expressed from time to time in our other filings with the SEC. In addition, historic results of scientific research, clinical and preclinical trials do not guarantee that the conclusions of future research or trials would not suggest different conclusions. Also, historic results referred to in this Quarterly Report on Form 10-Q could be interpreted differently in light of additional research, clinical and preclinical trials results. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this Quarterly Report on Form 10-Q. Except as required by law, we undertake no obligation to revise or update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this Quarterly Report on Form 10-Q. Readers are urged to carefully review and consider the various disclosures made throughout the entirety of this Quarterly Report on Form 10-Q which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operations and prospects.
iii
PART I – FINANCIAL INFORMATION
ITEM 1 - FINANCIAL STATEMENTS
ORAMED PHARMACEUTICALS INC.
INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
AS OF JUNE 30, 2025
TABLE OF CONTENTS
Page | ||
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS: | ||
Condensed Consolidated Balance sheets | 2 | |
Condensed Consolidated Statements of Comprehensive Income | 3 | |
Condensed Consolidated Statements of Changes in Equity | 4 | |
Condensed Consolidated Statements of Cash Flows | 5 | |
Notes to Condensed Consolidated Financial Statements | 6-28 |
1
ORAMED PHARMACEUTICALS INC.
INTERIM CONDENSED CONSOLIDATED BALANCE SHEETS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
June 30, | December 31, | |||||||
2025 | 2024 | |||||||
Assets | ||||||||
CURRENT ASSETS: | ||||||||
Cash and cash equivalents | $ | $ | ||||||
Short-term deposits | ||||||||
Marketable securities | ||||||||
Investments at fair value | ||||||||
Prepaid expenses and other current assets | ||||||||
Total current assets | ||||||||
LONG-TERM ASSETS: | ||||||||
Long-term deposits | ||||||||
Investments at fair value | ||||||||
Investment in associate at fair value | - | |||||||
Loan to an equity method investee | - | |||||||
Advance payments for real estate | - | |||||||
Other non-marketable equity securities | ||||||||
Amounts funded in respect of employee rights upon retirement | ||||||||
Property and equipment, net | ||||||||
Operating lease right-of-use assets | ||||||||
Total long-term assets | ||||||||
Total assets | $ | $ | ||||||
Liabilities and stockholders’ equity | ||||||||
CURRENT LIABILITIES: | ||||||||
Accounts payable and accrued expenses | $ | $ | ||||||
Payable to related parties | ||||||||
Deferred income | - | |||||||
Operating lease liabilities | ||||||||
Total current liabilities | ||||||||
LONG-TERM LIABILITIES: | ||||||||
Long-term deferred revenues | ||||||||
Long-term deferred income | - | |||||||
Employee rights upon retirement | ||||||||
Operating lease liabilities | ||||||||
Other liabilities | - | |||||||
Total long-term liabilities | ||||||||
COMMITMENTS (note 9) | ||||||||
EQUITY ATTRIBUTABLE TO COMPANY’S STOCKHOLDERS: | ||||||||
Common stock, $ | ||||||||
Additional paid-in capital | ||||||||
Accumulated deficit | ( | ) | ( | ) | ||||
Total stockholders’ equity | ||||||||
Non-controlling interests | ( | ) | ( | ) | ||||
Total equity | ||||||||
Total liabilities and equity | $ | $ |
The accompanying notes are an integral part of the condensed consolidated financial statements.
2
ORAMED PHARMACEUTICALS INC.
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
Six months ended | Three months ended | |||||||||||||||
June 30, | June 30, | June 30, | June 30, | |||||||||||||
2025 | 2024 | 2025 | 2024 | |||||||||||||
REVENUES | $ | - | $ | - | - | |||||||||||
COST OF REVENUE | ( | ) | - | - | - | |||||||||||
GROSS PROFIT | - | - | - | |||||||||||||
RESEARCH AND DEVELOPMENT EXPENSES | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
GENERAL AND ADMINISTRATIVE EXPENSES | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
OPERATING LOSS | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
OTHER INCOME, NET | - | - | ||||||||||||||
FINANCIAL INCOME, NET | ||||||||||||||||
INTEREST EXPENSES | - | ( | ) | - | ( | ) | ||||||||||
INCOME BEFORE TAX EXPENSES | $ | $ | ||||||||||||||
TAX BENEFIT (EXPENSES) | ( | ) | ( | ) | ( | ) | ||||||||||
NET INCOME | $ | $ | ||||||||||||||
NET INCOME (LOSS) ATTRIBUTABLE TO: | ||||||||||||||||
NON-CONTROLLING INTERESTS | ( | ) | ( | ) | ( | ) | ( | ) | ||||||||
COMPANY’S STOCKHOLDERS | ||||||||||||||||
BASIC INCOME PER SHARE OF COMMON STOCK | $ | $ | $ | $ | ||||||||||||
DILUTED INCOME PER SHARE OF COMMON STOCK | $ | $ | $ | $ | ||||||||||||
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING BASIC INCOME PER SHARE OF COMMON STOCK | ||||||||||||||||
WEIGHTED AVERAGE NUMBER OF SHARES OF COMMON STOCK USED IN COMPUTING DILUTED INCOME PER SHARE OF COMMON STOCK |
The accompanying notes are an integral part of the condensed consolidated financial statements.
3
ORAMED PHARMACEUTICALS INC.
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY
U.S. Dollars in thousands
(UNAUDITED)
Common Stock | Additional paid-in | Accumulated | Total stockholders’ | Non- controlling | Total | |||||||||||||||||||||||
Shares | $ | capital | deficit | equity | interests | equity | ||||||||||||||||||||||
In thousands | ||||||||||||||||||||||||||||
BALANCE AS OF DECEMBER 31, 2024 | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ | ||||||||||||||||||
CHANGES DURING THE SIX MONTH PERIOD ENDED JUNE 30, 2025: | ||||||||||||||||||||||||||||
STOCK-BASED COMPENSATION | - | - | ||||||||||||||||||||||||||
REPURCHASE AND RETIREMENT OF COMMON STOCK | ( | ) | ( | ) | ( | ) | - | ( | ) | - | ( | ) | ||||||||||||||||
NET INCOME | - | - | - | ( | ) | |||||||||||||||||||||||
BALANCE AS OF JUNE 30, 2025 | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ |
Common Stock | Additional paid-in | Accumulated | Total stockholders’ | Non- controlling | Total | |||||||||||||||||||||||
Shares | $ | capital | deficit | equity | interests | equity | ||||||||||||||||||||||
In thousands | ||||||||||||||||||||||||||||
BALANCE AS OF DECEMBER 31, 2023 | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ | ||||||||||||||||||
CHANGES DURING THE SIX MONTH PERIOD ENDED JUNE 30, 2024: | ||||||||||||||||||||||||||||
STOCK-BASED COMPENSATION | - | - | ||||||||||||||||||||||||||
STOCK-BASED COMPENSATION OF SUBSIDIARY | - | - | - | - | - | |||||||||||||||||||||||
NET INCOME | - | - | - | ( | ) | |||||||||||||||||||||||
BALANCE AS OF JUNE 30, 2024 | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ |
Common Stock | Additional paid-in | Accumulated | Total stockholders’ | Non- controlling | Total | |||||||||||||||||||||||
Shares | $ | capital | deficit | equity | interests | equity | ||||||||||||||||||||||
In thousands | ||||||||||||||||||||||||||||
BALANCE AS OF MARCH 31, 2025 | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ | ||||||||||||||||||
CHANGES DURING THE THREE MONTH PERIOD ENDED JUNE 30, 2025: | ||||||||||||||||||||||||||||
STOCK-BASED COMPENSATION | - | - | ||||||||||||||||||||||||||
REPURCHASE AND RETIREMENT OF COMMON STOCK | ( | ) | ( | ) | ( | ) | - | ( | ) | - | ( | ) | ||||||||||||||||
NET INCOME | - | - | - | ( | ) | |||||||||||||||||||||||
BALANCE AS OF JUNE 30, 2025 | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ |
Common Stock | Additional paid-in | Accumulated | Total stockholders’ | Non- controlling | Total | |||||||||||||||||||||||
Shares | $ | capital | deficit | equity | interests | equity | ||||||||||||||||||||||
In thousands | ||||||||||||||||||||||||||||
BALANCE AS OF MARCH 31, 2024 | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ | ||||||||||||||||||
CHANGES DURING THE THREE MONTH PERIOD ENDED JUNE 30, 2024: | ||||||||||||||||||||||||||||
STOCK-BASED COMPENSATION | - | - | ||||||||||||||||||||||||||
STOCK-BASED COMPENSATION OF SUBSIDIARY | - | - | - | - | - | |||||||||||||||||||||||
NET INCOME | - | - | - | ( | ) | |||||||||||||||||||||||
BALANCE AS OF JUNE 30, 2024 | $ | $ | $ | ( | ) | $ | $ | ( | ) | $ |
The accompanying notes are an integral part of the condensed consolidated financial statements.
4
ORAMED PHARMACEUTICALS INC.
INTERIM CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
U.S. dollars in thousands
(UNAUDITED)
Six months ended | ||||||||
June 30, | ||||||||
2025 | 2024 | |||||||
CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||
Net income | $ | $ | ||||||
Adjustments required to reconcile net income to net cash provided by (used in) operating activities: | ||||||||
Depreciation | ||||||||
Exchange differences and interest on deposits | ( | ) | ||||||
Changes in fair value of investments | ( | ) | ( | ) | ||||
Stock-based compensation | ||||||||
Gain on amounts funded in respect of employee rights upon retirement | ( | ) | ( | ) | ||||
Change in accrued interest on short-term borrowings | - | ( | ) | |||||
Changes in operating assets and liabilities: | ||||||||
Prepaid expenses and other current assets | ||||||||
Accounts payable, accrued expenses and related parties | ( | ) | ||||||
Net changes in operating lease | ||||||||
Deferred revenues | ( | ) | - | |||||
Deferred income | - | |||||||
Liability for employee rights upon retirement | ||||||||
Other liabilities | ( | ) | ( | ) | ||||
Total net cash provided by (used in) operating activities | ( | ) | ||||||
CASH FLOWS FROM INVESTING ACTIVITIES: | ||||||||
Purchase of short-term deposits | - | ( | ) | |||||
Proceeds from marketable securities | - | |||||||
Investment at fair value | ( | ) | - | |||||
Proceeds from redemption of short-term deposits | ||||||||
Proceeds from loan to an equity method investee | - | |||||||
Loan to investment in equity method | ( | ) | - | |||||
Advance payments for real estate | ( | ) | - | |||||
Equity method investee | ( | ) | - | |||||
Proceeds from long-term deposits | - | |||||||
Proceeds from investments | ||||||||
Purchase of property and equipment | ( | ) | ( | ) | ||||
Total net cash provided by (used in) investing activities | ( | ) | ||||||
CASH FLOWS FROM FINANCING ACTIVITIES: | ||||||||
Repurchase and retirement of common stock | ( | ) | - | |||||
Loans repaid | - | ( | ) | |||||
Total net cash used in financing activities | ( | ) | ( | ) | ||||
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS | ( | ) | ||||||
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | ( | ) | ||||||
CASH AND CASH EQUIVALENTS AT BEGINNING OF PERIOD | ||||||||
CASH AND CASH EQUIVALENTS AT END OF PERIOD | $ | $ | ||||||
(A) SUPPLEMENTARY DISCLOSURE ON CASH FLOWS - | ||||||||
Interest received | $ | $ | ||||||
Interest paid | $ | - | $ | ( | ) | |||
Taxes paid on income | $ | $ | - | |||||
(B) SUPPLEMENTAL DISCLOSURE OF NON-CASH ACTIVITIES - | ||||||||
Investment in equity method investee | ||||||||
Recognition of operating lease right-of-use assets and liabilities | ||||||||
Derecognition of right-of-use asset | - | ( | ) | |||||
Derecognition of lease liability | - | |||||||
Warrants received from Alpha Tau | - |
The accompanying notes are an integral part of the condensed consolidated financial statements.
5
ORAMED PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
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
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
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).
Joint venture with HTIT
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.
6
ORAMED PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
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 $
The second closing, which was initially set to close by May 31, 2025,
contingent on Nasdaq listing approval, involves a $
The JV Agreement also outlines the spin-off of OraTech, requiring
regulatory filings and the distribution of at least
As part of the JV Agreement, HTIT will receive $
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 a 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.
Scilex Transactions
See note 4 regarding the 2023 Scilex Transaction (as defined herein) and the 2024 Refinancing (as defined herein) and the Option Agreement (as defined in note 16b).
In connection with the Scilex Transaction,
on February 12, 2025, the Company received
Investment in Alpha Tau Medical Ltd.
In April 2025, the Subsidiary acquired approximately
7
ORAMED PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
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 per share of common stock |
Basic income per common stock are computed by dividing the net income 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”).
For the diluted income per share calculation
for the six and three months ended June 30, 2025 and 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
For the six and three month periods ended
June 30, 2025, options to purchase common stock, warrants and RSUs in the amount of
For the six and three month periods ended June 30, 2024, options to
purchase common stock, warrants and RSUs in the amount of
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.
8
ORAMED PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued):
c. | Recently issued accounting pronouncements, not yet adopted (continued): |
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.
In July 2025, the FASB issued ASU 2025-05 “Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses for Accounts Receivable and Contract Assets”. The ASU introduces a practical expedient for all entities when estimating expected credit losses for current accounts receivable and current contract assets arising from transactions accounted for under ASC 606. Under the practical expedient, when developing reasonable and supportable forecast as part of estimating expected credit losses, an entity may assume that current conditions as of the balance sheet date do not change for the remaining life of the asset. The ASU is effective for annual reporting periods beginning after December 15, 2025 and interim reporting within those annual reporting periods. Early adoption is permitted in both interim and annual reporting periods. The Company is evaluating the impact of ASU 2025-05 on its consolidated financial statements if it elects to apply the practical expedient.
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. |
9
ORAMED PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued):
d. | Fair value (continued): |
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:
June 30, 2025 | |||||||||||||||||
Level 1 | Level 2 | Level 3 | Total | ||||||||||||||
Assets: | |||||||||||||||||
Marketable Securities | |||||||||||||||||
DNA (as defined below) | - | - | |||||||||||||||
Entera (as defined below) | - | - | |||||||||||||||
Scilex (as defined below) | - | - | |||||||||||||||
Loan to an equity method investee (see note 4) | |||||||||||||||||
Tranche A Note (see note 4) | - | - | |||||||||||||||
Subsequent Penny Warrants (see note 4)(*) | - | ||||||||||||||||
Tranche B Note (see note 4) | - | - | |||||||||||||||
Warrants Note B (see note 4) | - | - | |||||||||||||||
Royalty Purchase Agreement (see note 4) | |||||||||||||||||
Loan agreement measured in fair value (see note 7) | - | - | |||||||||||||||
Investment in Alpha Tau's shares (see note 8) | - | - | |||||||||||||||
Investment in Alpha Tau's warrants (see note 8) | - | - | |||||||||||||||
Profit Sharing Loan Agreement (see note 6) | - | - | |||||||||||||||
$ | $ | - | $ | $ |
December 31, 2024 | |||||||||||||||||
Level 1 | Level 2 | Level 3 | Fair Value | ||||||||||||||
Assets: | |||||||||||||||||
Marketable Securities | |||||||||||||||||
DNA | - | - | |||||||||||||||
Entera | - | - | |||||||||||||||
Scilex | - | - | |||||||||||||||
Tranche A Note (see note 4) | - | - | |||||||||||||||
Subsequent Penny Warrants (see note 4)(*) | - | - | |||||||||||||||
Tranche B Note (see note 4) | - | - | |||||||||||||||
Warrants Note B (see note 4) | - | - | |||||||||||||||
Royalty Purchase Agreement (see note 4) | - | - | |||||||||||||||
Profit Sharing Loan Agreement (see note 6) | - | - | |||||||||||||||
$ | $ | $ | $ |
(*) |
10
ORAMED PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued):
d. | Fair value (continued): |
As of June 30, 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 $
Through June 30, 2025, the Company recognized
revenue associated with the HTIT License Agreement in an aggregate amount of $
11
ORAMED PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE 2 - SIGNIFICANT ACCOUNTING POLICIES (continued):
f. | Other income |
Alpha Tau
The Company recognizes income from
its Service Agreement with Alpha Tau for investor relations and public relations on a straight-line basis. Under the Service Agreement,
the Company is entitled to receive six semi-annual payments of $
During the quarter, the Company received
the first $
In addition, the Company recorded an
income of $
g. | Investment in Alpha Tau |
The Company
holds an investment in Alpha Tau granting it significant influence over the investee. In determining whether the Company has significant
influence, the Company considered not only whether its ownership is equal to or greater than
Investments granting significant influence are generally accounted for under the equity method. For the investment in Alpha Tau, the Company has elected the fair value option under ASC 825-10. The fair value option has been elected as the Company believes it best reflects the underlying economics of the investment in Alpha Tau. As a result, the Company recognizes the change in the fair value in “Financial income, net”.
Summarized financial information for Alpha Tau, as determined in accordance with Rule 8-03(b)(3) of Regulation S-X is included in Note 8.
12
ORAMED PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
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 income.
Composition |
June 30, 2025 | December 31, 2024 | ||||||||
Short -term: | |||||||||
DNA | $ | $ | |||||||
Entera | |||||||||
Scilex | |||||||||
$ | $ |
NOTE 4 - INVESTMENTS, AT FAIR VALUE
On April 14, 2025, Scilex effected a
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 $ |
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 $
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
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 $
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.
b. | Warrants to purchase up to |
On October 30, 2024, the Company exercised
13
ORAMED PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE 4 - INVESTMENTS, AT FAIR VALUE (continued)
2023 Scilex Transaction and 2024 Refinancing
2023 Scilex Transaction (continued)
c. | Transferred warrants (the “Transferred Warrants”)
to purchase |
Following the 2024 Refinancing (as defined
and described below), on October 8, 2024, Scilex used $
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, 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 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
Until March 31, 2025 the fair value of the Subsequent Penny Warrants was calculated based on the closing price of the Scilex common stock on the Nasdaq Capital Market. However, on June 30, 2025, the Company used a fair value methodology. For more information see note 2(d).
The table below represents the fair value composition of the Tranche Note A:
June 30, 2025 | December 31, 2024 | ||||||||
Tranche A Note | $ | $ | |||||||
Subsequent Penny Warrants | $ | $ | |||||||
Total | $ | $ |
As of June 30, 2025 and December 31, 2024, the Tranche A Note is included under Investments at fair value, current assets.
As of December 31, 2024, and June 30,
2025, the fair value of the Tranche A Note was less than the aggregate unpaid principal balance (which includes interest payable on maturity)
by $
14
ORAMED PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE 4 - INVESTMENTS, AT FAIR VALUE (continued):
2023 Scilex Transaction and 2024 Refinancing (continued)
2024 Refinancing (continued)
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 $
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 $
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,
In consideration for its interest in
the Purchased Receivables, the Company exchanged and reduced $
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.
15
ORAMED PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE 4 - INVESTMENTS, AT FAIR VALUE (continued):
2023 Scilex Transaction and 2024 Refinancing (continued)
2024 Refinancing (continued)
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 Note to October 8, 2026. In consideration, the Company received $
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 |
● | The Tranche B Note holders had the option, through RoyaltyVest, to
fund up to |
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, net and include interest income on the Tranche B Note.
The valuation of the Tranche B Note was
performed based on the binomial model, using a discount rate of
Parameters and Assumptions | |||||
Share Price | $ | ||||
Conversion Rate | |||||
Floor Rate | |||||
Expected Term | |||||
Volatility | % | ||||
Risk Free Rate | % | ||||
Yield | % |
16
ORAMED PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE 4 - INVESTMENTS, AT FAIR VALUE (continued):
2023 Scilex Transaction and 2024 Refinancing (continued)
2024 Refinancing (continued)
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 June 30, 2025:
Parameters and Assumptions | |||||
Share Price | $ | ||||
Exercise Price | $ | ||||
Expected Term | |||||
Volatility | % | ||||
Risk Free Rate | % | ||||
Dividend Rate | % |
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 between
As of December 31, 2024, and June 30,
2025, the fair value of the Tranche B Note was less than the aggregate unpaid principal balance by $
In April 2025, and in accordance with
Tranche B Note terms, the Company received from Scilex repayment of $
The table below represents the fair value composition of the Tranche B Note:
June 30, 2025 | December 31, 2024 | ||||||||||||||||||||||||
Short term | Long term | Total | Short term | Long term | Total | ||||||||||||||||||||
Tranche Note B | $ | $ | $ | $ | $ | ||||||||||||||||||||
Warrant | - | - | $ | $ | |||||||||||||||||||||
Royalty Purchase Agreement | $ | $ | $ | $ | |||||||||||||||||||||
Total | $ | $ | $ | $ | $ |
Scilex Transaction Summary
The table below represents the fair value cycle of 2023 Scilex Transaction and 2024 Refinancing transaction throughout December 31, 2024 and June 30, 2025:
Tranche A | Tranche B | Total | |||||||||||
Balance as of December 31, 2023 | $ | - | $ | ||||||||||
2024 Refinancing | ( | ) | |||||||||||
Proceeds from the sale of Transferred Warrants | ( | ) | - | ( | ) | ||||||||
Cash received from Tranche A Note repayment | ( | ) | - | ( | ) | ||||||||
Exercised warrants (*) | ( | ) | - | ( | ) | ||||||||
Amounts receivable from the royalty agreement | - | ( | ) | ( | ) | ||||||||
Change in fair value | ( | ) | ( | ) | ( | ) | |||||||
Balance as of December 31, 2024 | |||||||||||||
Amounts receivable from the royalty agreement (**) | - | ( | ) | ( | ) | ||||||||
Principal payments | ( | ) | ( | ) | |||||||||
Interest payments | ( | ) | ( | ) | |||||||||
Change in fair value | |||||||||||||
Balance as of June 30, 2025 | $ | $ | $ |
(*) |
(**) |
17
ORAMED PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE 4 - INVESTMENTS, AT FAIR VALUE (continued):
2023 Scilex Transaction and 2024 Refinancing (continued)
Scilex Transaction Summary (continued)
Financial income recognized in respect
of the 2023 Scilex Transaction and the 2024 Refinancing, for the six and three months ended June 30, 2025, were $
Financial income recognized in respect
of the 2023 Scilex Transaction, for the six and three months ended June 30, 2024, were $
The table below represents the fair value breakdown as of June 30, 2025:
Tranche A Note | Tranche B Note | Total | |||||||||||||||||||
Amount | Fair Value | Amount | Fair Value | Fair Value | |||||||||||||||||
Notes (*) | $ | $ | $ | $ | $ | ||||||||||||||||
Warrants (**) | $ | $ | $ | ||||||||||||||||||
Royalty Purchase Agreement payment | - | - | - | $ | $ | ||||||||||||||||
June 30, 2025 | - | $ | - | $ | $ |
(*) |
(**) |
During the three months ended June 30, 2025, the Company sold
As of June 30, 2025, the Company held
All Scilex securities described above
are subject to a beneficial ownership limitation, which restricts the Company’s holdings to a maximum of
For additional information regarding the measurement of the Subsequent Penny Warrants, see note 2(d).
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
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 4
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
18
ORAMED PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
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
As of June 30, 2025, the Company held
a
There are no unrecognized losses, guarantees, or commitments related to RoyaltyVest. In addition, no impairment losses were recorded during the reporting periods.
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 $
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
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) $
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
19
ORAMED PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE 6 - EQUITY METHOD INVESTEE (continued):
c. | BioXcel |
On March 4, 2025, RoyaltyVest participated
in a registered direct offering by BioXcel, acquiring
As of June 30, 2025, RoyaltyVest has sold
NOTE 7 - LOAN AGREEMENT MEASURED IN FAIR VALUE
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 up to $
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 $
In April 2025,
the Company loaned $
The Company decided to designate the loan agreement as a whole under
the fair-value option in accordance with ASC Topic 825 “Financial Instruments”. The valuation of the loan agreement was calculated
in accordance with the weighted average expected cashflows of the loan. The predicted weighted average cashflows of the loan were discounted
at a rate of
The table below represents the fair value breakdown as of June 30, 2025:
Hapisga | Tova Chochama | Total | ||||||||||
Loan | $ | $ | $ | |||||||||
Loan repayment | $ | $ | ( | ) | $ | ( | ) | |||||
Fair value measurement | $ | $ | ||||||||||
Fair value as of June 30, 2025 | $ | $ | $ |
20
ORAMED PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE 8 - INVESTMENT IN ASSOCIATE AT FAIR VALUE
On April 24, 2025, the Subsidiary entered
into a share purchase agreement with Alpha Tau ("SP Agreement"), pursuant to which the Subsidiary purchased
Concurrently, the Subsidiary and Alpha Tau entered
into the 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 fee of $
Due to the Company’s significant influence over operating and financial policies, Alpha Tau is considered a related party of the Company.
The following presents summarized financial information related to Alpha Tau as of June 30, 2025. This aggregate information has been compiled from the financial statements of Alpha Tau.
April 24, 2025 - June 30, 2025 | ||||
Net loss | $ |
The amount presented above reflects Alpha Tau’s total net loss for the period and is calculated on a straight-line basis, as there were no significant transactions during the period.
On April 24, 2025 and June 30, 2025, the fair
value of the Company’s investment in Alpha Tau was $
The warrants issued under the Services Agreement are accounted as a separate transaction from the SP Agreement. The fair value of the warrants on the issuance date 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 Alpha Tau warrants as of June 23, 2025, and June 30, 2025:
As of | ||||||||
Parameters and Assumptions | June 23, 2025 | June 30, 2025 | ||||||
Share Price | $ | $ | ||||||
Exercise Price | $ | $ | ||||||
Expected Term | ||||||||
Volatility | % | % | ||||||
Risk Free Rate | % | % | ||||||
Dividend Rate | % | % |
As of June 23, 2025, the issuance date, the fair
value of the Alpha Tau warrants was $
21
ORAMED PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE 9 - COMMITMENTS:
a. | Grants from the Israel Innovation Authority (“IIA”) |
Under the terms of the Company’s
funding from the IIA, royalties of
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 $
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 $
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 $
22
ORAMED PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE 10 - ACCOUNTS PAYABLE AND ACCRUED EXPENSES:
Composition:
June 30, 2025 | December 31, 2024 | ||||||||
Accounts payable | $ | $ | |||||||
Payroll and related accruals | |||||||||
Income tax | |||||||||
Accrued liabilities | |||||||||
$ | $ |
NOTE 11 - STOCKHOLDERS’ EQUITY:
Stock -based compensation
Below is a table summarizing all of the RSUs grants to employees made during the six months ended June 30, 2025.
No. of RSUs granted | Exercise price | Vesting period | Fair value at grant (*) | |||||||||||||
Employees | - | (** | ) | $ |
(*) |
(**) |
23
ORAMED PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE 11 - STOCKHOLDERS’ EQUITY (continued):
Performance restricted stock units (“PSUs”) granted
On January 2, 2025, the Company granted
On January 2, 2025, the Board modified
As of June 30, 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 $
On June 5, 2025, the Company granted
an aggregate of
On June 5, 2025, the Company granted
an aggregate of
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
$
On May 21, 2025, the Company’s
board of directors authorized a one-year extension of the Company’s current stock buyback program, which was set to expire in June
2025, pursuant to which the Company may, from time to time, purchase up to $
During the three and the six months
ended June 30, 2025, the Company has repurchased
24
ORAMED PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE 12 - LEASES:
The Company has various operating leases for office space and vehicles. During the six months ended June 30, 2025, the Company exercised the extension option for a portion of its office space, extending the lease term until August 31, 2030.
In connection with the extension of the lease agreement, the Company remeasured the right-of-use (ROU) asset and corresponding lease liability in accordance with ASC 842. The updated balances reflect the revised lease term and related payment obligations through August 31, 2030.
Below is a summary of the Company’s operating right-of-use assets and operating lease liabilities as of June 30, 2025 and December 31, 2024:
June 30, 2025 | December 31, 2024 | |||||||
Operating right-of-use assets | $ | $ | ||||||
Operating lease liabilities, current | ||||||||
Operating lease liabilities long-term | ||||||||
Total operating lease liabilities | $ | $ |
Lease payments for the Company’s right-of-use assets over the remaining lease periods as of June 30, 2025 and December 31, 2024 are as follows:
June
30, 2025 |
December 31, 2024 |
|||||||
2025 | ||||||||
2026 | ||||||||
2027 | ||||||||
2028 | - | |||||||
2029 | - | |||||||
2030 | - | |||||||
Total undiscounted lease payments | ||||||||
Less: Interest* | ( |
) | ( |
) | ||||
Present value of lease liabilities | $ | $ |
* |
25
ORAMED PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE 13 - FINANCIAL INCOME, NET:
Six months ended | Three months ended | |||||||||||||||
June 30, 2025 | June 30, 2024 | June 30, 2025 | June 30, 2024 | |||||||||||||
Interest Income | $ | $ | $ | $ | ||||||||||||
Revaluation of investments: | ||||||||||||||||
Revaluation of Scilex, net (see note 4) | ||||||||||||||||
Revaluation of Hapisga, net (see note 7) | - | - | ||||||||||||||
Revaluation of Alpha Tau, net (see note 8) | - | - | ||||||||||||||
Revaluation of RoyaltyVest loan, net (see note 4) | ( | ) | - | ( | ) | - | ||||||||||
Revaluation of Profit Sharing Loan Agreement (see note 6) | - | - | ||||||||||||||
Revaluation of other marketable securities | ( | ) | ||||||||||||||
$ | $ | $ | $ |
NOTE 14 - SEGMENT REPORTING:
The CODM monitors budgeted versus actual net income, 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, Hapisga and Alpha Tau, see note 4, note 7 and note 8. The CODM monitors these investments separately from operational performance. Income and expenses related to financial instruments are reported as financial income in the consolidated statements of comprehensive income, reflecting their distinct nature from core business operations
NOTE 15 - 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
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
26
ORAMED PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE 15 - RELATED PARTY TRANSACTIONS (continued):
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
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
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
NOTE 16 - SUBSEQUENT EVENTS:
a. Scilex - Tranche B Note
In July 2025, and in accordance with
Tranche B Note terms, the Company received from Scilex repayment of $
b. Subsequent Penny Warrants
On July 14, 2025, the Company entered
into an option agreement (the “Option Agreement”) with Scilex, granting Scilex the right to repurchase the Company’s
remaining
On August 6, 2025, Scilex paid the initial
option fee of $
27
ORAMED PHARMACEUTICALS INC.
NOTES TO INTERIM CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
U.S. Dollars in thousands (except share and per share data)
(UNAUDITED)
NOTE 16 - SUBSEQUENT EVENTS (continued):
c. Pelthos Therapeutics Inc. Securities Purchase Agreement
On July 1, 2025, the Company entered into a securities purchase agreement with Pelthos Therapeutics Inc. (“PTHS”), pursuant
to which the Company invested $
In connection with this transaction, the Company entered into a customary registration rights agreement with PTHS and a customary lock-up agreement pursuant to which the Company is not permitted to sell its shares of PTHS until December 31, 2025, subject to exceptions and earlier termination as set forth in the lock-up agreement.
d. Alpha Tau
Subsequent to June 30, 2025 and through
August 12, 2025, the Company purchased an additional
e. BioXcel/RoyaltyVest
Subsequent to June 30, 2025 and through August 12, 2025, RoyaltyVest
sold
f. Scilex
Subsequent to June 30, 2025 and through
August 12, 2025, the Company sold its remaining
g. On July 4, 2025, the One Big Beautiful Bill Act (OBBBA) was signed into law. This legislation includes changes to U.S. federal tax law, which may be subject to further clarification and the issuance of interpretive guidance. The Company is assessing the legislation and its effect on its consolidated financial statements.
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ITEM 2 - MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the condensed consolidated financial statements and the related notes included elsewhere herein and in our consolidated financial statements, accompanying notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in our Annual Report.
Overview of Operations
We are a pharmaceutical company engaged in the research and development of innovative pharmaceutical solutions with a technology platform that allows for the oral delivery of therapeutic proteins.
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.
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.
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.
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.
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.
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, we paused plans to initiate a 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.
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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, except of the Subsequent Penny Warrants that were outstanding as of the reverse stock split date, that were not adjustable under the reverse split.
2023 Scilex Transaction
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:
a. | A senior secured promissory note, or the Tranche A Note, with a principal amount of $101,875,000, 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. In January 2025, we extended Tranche A Note maturity from March 21, 2025 to December 31, 2025. 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 approximately $3,056,000. Since the Tranche A Note was not repaid by March 21, 2024, we are entitled to the above-mentioned exit fee at the maturity date of the Tranche A Note. As of May 14, 2025, Scilex has repaid $69,200,000 of the amount due under the Tranche A Note and refinanced $25,000,000 as part of the 2024 Refinancing (as defined below).
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 as mentioned above.
On January 21, 2025, we entered into an amendment to the Tranche A Note, or the Tranche A Extension agreement, extending the maturity date from March 21, 2025, to December 31, 2025 or the Extended Maturity Date. Interest will continue to accrue and be payable on the Extended Maturity Date. In consideration of the extension, we received 92,858 shares of Scilex common stock. |
b. | Warrants to purchase up to 128,572 shares of Scilex common stock with an exercise price of $0.35 per share, or the Closing Penny Warrants, and additional warrants, or the Subsequent Penny Warrants, for 57,143 (after the implementation of the reverse stock split) and 6,500,000 (which were not affected by the reverse stock split) shares of Scilex common stock with an exercise price of $0.35 and $0.01 per share, respectively. The Closing Penny Warrants vested on September 21, 2023, and the Subsequent Penny Warrants vested during 2024.
On October 30, 2024, we exercised 128,572 Closing Penny Warrants and 57,143 Subsequent Penny Warrants that were exercisable at such time. As a result, we hold 187,715 shares of common stock of Scilex.
As of June 30, 2025, the Closing Penny Warrants and the Subsequent Penny Warrants are fully vested and exercisable. |
c. | Transferred warrants, or the Transferred Warrants, to purchase 114,286 shares of Scilex common stock with an exercise price of $402.5 per share, fully exercisable and expiring on November 10, 2027. On September 20, 2024, we sold the Transferred Warrants for consideration of $300,000 (see below). As a result, as of May 14, 2025 we do not hold any Transferred Warrants. |
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2024 Refinancing
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) new tranche B of senior secured convertible notes of Scilex in the aggregate principal amount of $50,000,000, or the Tranche B Note, which Tranche B Note is 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 $36.4, 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.
Scilex received from us, in consideration for our part in Tranche B Note 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.
Royalty Purchase Agreement
In addition to the Tranche B Note, 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.
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.
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.
ZTLido Rest of the World Binding Agreement
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.
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.
Tranche B Note Consent
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.
In addition, as part of the Tranche B Consent and contingent upon certain conditions that were met:
1. | Scilex and the Tranche B Noteholders agreed to a 10-year, assignable 4% royalty on global net sales of Gloperba and Elyxyb in certain territories outside of the United States, or ROW, of which, we are entitled to 2% royalties. 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. |
2. | The Tranche B Noteholders had the option, through RoyaltyVest, to fund up to 50% of the cash purchase price for ROW product rights to Gloperba and Elyxyb (excluding Elyxyb in Canada) and will receive proportional revenues from commercialization and licensing. As of June 30, 2025, RoyaltyVest exercised its option to Ex-U.S. product rights of Gloperba for $500. |
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Royalty Purchase Agreement — Gloperba and Elyxyb
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.
ZTLido License Agreement
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.
Gloperba Rest of World License Agreement
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.
Subsequent penny warrant agreement
As of June 30, 2025, we held 6,500,000 Subsequent Penny Warrants which are fully vested and exercisable. The Subsequent Penny Warrants were not subject to adjustment in connection with the 1-for-35 reverse stock split effected by Scilex in April 2025, and accordingly, continue to entitle us to purchase 6,500,000 shares of Scilex common stock. On July 14, 2025, the Company entered into an option agreement (the “Option Agreement”) with Scilex, granting Scilex the right to repurchase the Company’s remaining 6,500,000 Subsequent Penny Warrants for a total purchase price of $27,000,000. In exchange for the Option Agreement, Scilex agreed to pay to the Company a non-refundable fee of $1,500,000 in two equal installments. The repurchase is structured in two tranches: $13,000,000 for 3,130,000 Subsequent Penny Warrants on or before September 30, 2025, and $14,000,000 for 3,370,000 Subsequent Penny Warrants on or before December 31, 2025. If Scilex completes the full repurchase and pays the associated option fee, the maturity of the Tranche A Note will be extended to March 31, 2026. Until the earlier of the expiration or termination of the Option Agreement, the Company has agreed not to exercise the Subsequent Penny Warrants. The fulfilment of the Option Agreement is subject to the ability of Scilex to have sufficient cash. If the agreement is terminated without completion, the Company may exercise the Subsequent Penny Warrants, subject to applicable Nasdaq shareholder approval thresholds.
BioXcel
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.
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.
Subsequent to June 30, 2025 and through August 12, 2025, RoyaltyVest has sold 80,612 shares of BioXcel common stock and 1,358,942 pre-funded warrants. Following these transactions, RoyaltyVest continues to hold 3,000,000 warrants and no longer holds any shares or pre-funded warrants of BioXcel.
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Alpha Tau Transaction
On April 24, 2025, Oramed Ltd. entered into a share purchase agreement with Alpha Tau Medical Ltd. (Nasdaq: DRTS), or Alpha Tau, a clinical-stage oncology company developing a proprietary alpha-radiation cancer therapy platform known as Alpha DaRT™. Pursuant to the agreement, 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 and has nominated two directors to Alpha Tau’s board of directors. In addition, during the three months ended June 30, 2025, we purchased an additional 87,930 shares of Alpha Tau for an aggregate amount of $250,000. Subsequent to June 30, 2025 and through August 12, 2025, the Company purchased an additional 59,123 ordinary shares of Alpha Tau for an aggregate purchase price of $187,000.
Concurrently, Oramed Ltd. and Alpha Tau entered into a 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.
Alpha Tau’s Alpha DaRT™ platform is designed to deliver highly localized alpha radiation to solid tumors, potentially offering a novel treatment solution for patients with otherwise difficult-to-treat cancers. Alpha Tau has recently shown encouraging clinical progress, particularly in pancreatic and head and neck cancers, where interim data demonstrated strong disease control and early signals of extended survival. With U.S. Food and Drug Administration approvals secured for upcoming U.S. trials and ongoing global studies, Alpha Tau is entering a critical phase of clinical validation. As investors, we believe Alpha Tau represents a compelling opportunity—combining innovative science, a scalable platform, and growing regulatory momentum.
Impact of Current Events
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 August 13, 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.
Real Estate Investments
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.
Real Estate Transactions
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 $237,000) will be loaned upon certain milestones which are expected to occur in the second 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.
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 August 12, 2025, we have completed payment of the full purchase price.
Loan to Hapisga Project
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 up to $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 NIS 3,000,000,000 (approximately $890,000,000), 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. In May 2025, Tova Chochma repaid an amount of $500,000. 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.
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Results of Operations
Comparison of six and three months ended June 30, 2025 and 2024
The following table summarizes certain statements of operations data of the Company for the six and three months ended June 30, 2025 and 2024 (in thousands of dollars except share and per share data):
Six months ended | Three months ended | |||||||||||||||
June 30, 2025 | June 30, 2024 | June 30, 2025 | June 30, 2024 | |||||||||||||
Revenues | $ | 2,000 | $ | - | $ | - | $ | |||||||||
Cost of revenue | (1,987 | ) | - | - | - | |||||||||||
Gross profit | 13 | - | - | - | ||||||||||||
Research and development expenses | (3,240 | ) | (2,621 | ) | (1,034 | ) | (1,442 | ) | ||||||||
General and administrative expenses | (3,762 | ) | (3,476 | ) | (1,455 | ) | (1,693 | ) | ||||||||
Operating loss | (6,989 | ) | (6,097 | ) | (2,489 | ) | (3,135 | ) | ||||||||
Interest expenses | - | (853 | ) | - | (261 | ) | ||||||||||
Other income, net | 257 | - | 257 | - | ||||||||||||
Financial income, net | 12,808 | 19,322 | 15,366 | 14,234 | ||||||||||||
Income before tax expenses | 6,076 | 12,372 | 13,134 | 10,838 | ||||||||||||
Tax benefit (expenses) | (458 | ) | (1,634 | ) | 126 | (1,634 | ) | |||||||||
Net income | 5,618 | 10,738 | 13,260 | 9,204 | ||||||||||||
Net income (loss) attributable to: | ||||||||||||||||
Non-controlling interests | (28 | ) | (10 | ) | (28 | ) | (8 | ) | ||||||||
Company's stockholders | 5,646 | 10,748 | 13,288 | 9,212 | ||||||||||||
Basic income per share of common stock | 0.14 | 0.26 | 0.32 | 0.22 | ||||||||||||
Diluted income per share of common stock | 0.13 | 0.26 | 0.31 | 0.22 | ||||||||||||
Weighted average number of shares of common stock outstanding used in computing basic income per share of common stock | 41,488,994 | 40,899,275 | 41,743,486 | 40,959,759 | ||||||||||||
Weighted average number of shares of common stock outstanding used in computing diluted income per share of common stock | 42,884,004 | 41,427,849 | 42,609,425 | 41,591,007 |
Revenues
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.
We recognized $2,000,000 revenue related to the HTIT License Agreement in the six months ended June 30, 2025 while there were no revenues for the six months ended June 30, 2024. We did not recognize any revenue on the three months ended June 30, 2025 or 2024.
Cost of Revenues
On February 18, 2025, we received approval from Israel Innovation Authority, or 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 we pay the aggregate IIA grant amount, plus accrued interest, less all royalties paid to date.
On February 27, 2025, we fulfilled our payment obligation by remitting approximately $2,046,000 to the IIA, and as result we have no further obligations to the IIA. $1,987,000 of the amount is recognized in cost of revenue during the six months ended June 30, 2025. The amount of $59,000 was recognized in previous periods. There were no costs of revenue for the three months ended June 30, 2025 and for the six and three months ended June 30, 2024.
Research and Development Expenses
Research and development expenses include costs directly attributable to the conduct of research and development programs, including the cost of salaries, employee benefits, costs of materials, supplies, the cost of services provided by outside contractors, including services related to our clinical trials, clinical trial expenses, the full cost of manufacturing drugs for use in research and preclinical development. All costs associated with research and development are expensed as incurred.
Clinical trial costs are a significant component of research and development expenses and include costs associated with third-party contractors. We outsource a substantial portion of our clinical trial activities, utilizing external entities such as contract research organizations, or CROs, independent clinical investigators and other third-party service providers to assist us with the execution of our clinical trials.
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Clinical activities, which relate principally to clinical sites and other administrative functions to manage our clinical trials, are performed primarily by CROs. CROs typically perform most of the start-up activities for our trials, including document preparation, site identification, screening and preparation, pre-trial visits, training and program management.
Clinical trial and preclinical trial expenses include regulatory and scientific consultants’ compensation and fees, research expenses, purchase of materials, cost of manufacturing of the oral insulin and exenatide capsules, payments for patient recruitment and treatment, as well as salaries and related expenses of research and development staff.
Research and development expenses for the six months ended June 30, 2025 increased by 24% to approximately $3,240,000, compared to approximately $2,621,000 for the six months ended June 30, 2024. The increase was primarily driven by costs related to preparations for a new Phase 3 clinical trial (ORA-D-013-3).
Research and development expenses for the three months ended June 30, 2025 decreased by 28% to approximately $1,034,000, compared to approximately $1,442,000 for the three months ended June 30, 2024. The decrease is mainly due to a decrease in the stock-based compensation expenses and a decrease in clinical trial expenses.
General and Administrative Expenses
General and administrative expenses include the salaries and related expenses of our management, consulting expenses, legal and professional fees, travel expenses, business development expenses, insurance expenses and other general expenses.
General and administrative expenses for the six months ended June 30, 2025 increased by 8% to approximately $3,762,000 compared to approximately $3,476,000 for the six months ended June 30, 2024. The increase was mainly due to stock-based compensation expenses, which partially offset by a decrease in legal expenses and D&O insurance expenses.
General and administrative expenses for the three months ended June 30, 2025 decreased by 14% to approximately $1,455,000 compared to approximately $1,693,000 for the three months ended June 30, 2024. The decrease was mainly due to a decrease of stock-based compensation expenses.
Interest Expenses
There were no interest expenses for the six and three months ended June 30, 2025, compared to interest expenses of $853 and $261 for the six and three months ended June 30, 2024, since the Short-Term Borrowings (as defined below) received from Israel Discount Bank Ltd. were terminated during the second quarter of 2024.
Financial Income, Net
Net financial income were approximately $12,808,000 for the six months ended June 30, 2025, compared to financial income of approximately $19,322,000 for the six months ended June 30, 2024. The decrease was primarily due to the revaluation of the investment in Scilex, RoyaltyVest and a decrease in interest income on deposits, partially offset by the revaluation of Alpha Tau.
Net financial income were approximately $15,366,000 for the three months ended June 30, 2025, compared to financial income of approximately $14,234,000 for the three months ended June 30, 2024. The increase was primarily due to the revaluation of Alpha Tau, partially offset by the revaluation of the investment in Scilex and RoyaltyVest.
Tax on income
During the six months ended June 30, 2025, we recognized tax expenses on income of approximately $458,000 compared to tax on income of approximately $1,634,000 for the six months ended June 30, 2024. The tax on income is primarily attributable to the 2023 Scilex Transaction and the 2024 Refinancing.
During the three months ended June 30, 2025, we recognized tax benefit on income of approximately $126,000 compared to tax expenses on income of approximately $1,634,000 for the three months ended June 30, 2024. The tax benefit is mainly due to a change in the tax provision in the three months ended June 30, 2025.
The provision for tax on income in the interim period is determined using an estimated annual effective tax rate.
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Liquidity and Capital Resources
From our inception through June 30, 2025, we have incurred losses in an aggregate amount of approximately $170,970,000. During that period and through June 30, 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 June 30, 2025, we had approximately $15,797,000 of available cash and approximately $22,865,000 of short-term bank deposits. In addition, we hold a variety of interests in certain investments, including in Scilex, Alpha Tau and others, as further detailed in this Quarterly Report on Form 10-Q.
From inception through June 30, 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.
Based on our current cash resources and commitments, we believe we will be able to maintain our current planned activities and the corresponding level of expenditures for at least the next 12 months.
As of June 30, 2025, our total current assets were approximately $99,026,000 and our total current liabilities were approximately $3,693,000. On June 30, 2025, we had a working capital surplus of approximately $95,333,000 and an accumulated loss of approximately $170,970,000. 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 to a decrease in cash and cash equivalents and short-term deposits that was partially offset by an increase in fair value investments.
During the six months ended June 30, 2025, cash and cash equivalents decreased to approximately $15,797,000 from approximately $54,420,000 as of December 31, 2024. The decrease was mainly due to investments in Alpha Tau, RoyaltyVast and Hapisga, partially offset by the decrease in short-term deposits.
Operating activities used cash of approximately $7,054,000 in the six months ended June 30, 2025, compared to approximately $600,000 provided in the six months ended June 30, 2024. Cash used in operating activities primarily consisted of research and development expenses, general and administrative expenses and the change in fair value of investments.
Investing activities used cash of approximately $31,237,000 in the six months ended June 30, 2025, compared to approximately $124,653,000 provided in the six months ended June 30, 2024. Cash used in investing activities in the six months ended June 30, 2025 consisted primarily of investments at fair value in Alpha Tau and Hapisga, partially offset by proceeds from short-term deposits. Cash provided by investing activities in the six months ended June 30, 2024 is mainly due to proceeds from short-term deposits and from Scilex.
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Financing activities used cash of approximately $371,000 in the six months ended June 30, 2025, compared to cash used for financing activities of approximately $49,550,000 in the six months ended June 30, 2024. Cash used for financing activities in the six months ended June 30, 2025, consisted primarily of purchase of treasury shares. Cash used in financing activities in the six months ended June 30, 2024 was mainly due to loan repayment.
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 June 30, 2025, we had repaid the entire Short-Term Borrowings amount.
Critical accounting policies and estimates
Our critical accounting policies are described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contained in our Annual Report.
Planned Expenditures
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.
ITEM 3 - QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not applicable to small reporting companies.
ITEM 4 - CONTROLS AND PROCEDURES
Disclosure Controls and Procedures
Our management, including our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30, 2025. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures are effective.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting that occurred during the quarter ended June 30, 2025 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
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PART II –
ITEM 1A - RISK FACTORS
We may not realize the value of the Option Agreement and Subsequent Penny Warrants that we expect.
Our ability to realize the full value of the Option Agreement, or to complete the repurchase of the Subsequent Penny Warrants under its terms, is subject to significant uncertainty. There can be no assurance that Scilex will make the required payments or complete the repurchase within the agreed timeline, if at all. If the Option Agreement is terminated or Scilex fails to fulfill its obligations, our ability to monetize or exercise the warrants remains limited due to both regulatory and practical constraints. Specifically, Nasdaq Listing Rule 5635(d) requires shareholder approval for the issuance of securities exceeding 20% of a company’s outstanding shares at below-market prices. As a result, we may be unable to exercise or sell the full amount of the warrants without triggering such restrictions. These limitations may prevent us from realizing the full economic benefit of the Penny Warrants.
Our various real estate and other investments, including, but not limited to Alpha Tau, a clinical-stage company, involve significant risks and might not provide long-term value appreciation and potential income streams that we expect to receive.
As of the day of this report, we have various real estate and other investments, including, but not limited to Alpha Tau, a clinical-stage company, which constitute a part of our business strategy. We believe that these investments could provide long-term value appreciation and potential income streams, further strengthening our financial position and maximizing shareholder value.
However, these investments involve significant risks and might not provide long-term value appreciation and potential income streams that we expect to receive. For example, if Alpha Tau fails to achieve positive clinical results or obtain regulatory approvals, the value of our investment could decline materially, which may adversely affect our financial results. Additionally, conditions in the real estate market might change, which, in turn, might affect the value of our real estate investments.
ITEM 2 – UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
In June 2024, our board of directors authorized a stock buyback and retirement program pursuant to which we may, from time to time, repurchase up to $20 million 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 us to purchase any shares and expires in 12 months. The authorization for the stock buyback program may be terminated, increased or decreased by our board of directors in its discretion at any time.
We have repurchased and retired 1,200,845 shares of our common stock under this program for approximately $2,844,000, at an average price of $2.37 per share. All purchases were funded with cash on hand.
On May 21, 2025, our board of directors authorized a one-year extension of our current stock buyback program, which was set to expire in June 2025, pursuant to which we may, from time to time, purchase up to $20,000,000 in maximum value of our common stock.
During the three months ended June 30, 2025, we repurchased and retired 163,869 common stock. The following sets forth information with respect to repurchase and retirement made by the us of our shares of common stock during the quarter ended June 30, 2025:
Period | Total number of shares purchased | Average price paid per share | Total number of shares purchased as part of publicly announced plans or programs | Approximate dollar value of shares that may yet be purchased under the plans or programs | ||||||||||||
April 1-30, 2025 | - | $ | - | - | $ | 17,516,000 | ||||||||||
May 1-31, 2025 | 46,233 | $ | 2.19 | 46,233 | $ | 17,415,000 | ||||||||||
June 1-30, 2025 | 117,636 | $ | 2.20 | 117,636 | $ | 17,156,000 | ||||||||||
Total | 163,869 | $ | 2.20 | 163,869 | $ | 17,156,000 |
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ITEM 6 - EXHIBITS
Number | Exhibit | |
10.1 | Option Agreement for Repurchase of Warrants, dated July 22, 2025, between Scilex Holding Company and Oramed Pharmaceuticals Inc. (incorporated by reference from our Current Report on Form 8-K filed on July 23, 2025) | |
31.1* | Certification of Principal Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a) under the Securities Exchange Act of 1934, as amended. | |
31.2* | Certification of Principal Financial Officer pursuant to Rule 13a-14(a) and 15(d)-14(a) under the Securities Exchange Act of 1934, as amended. | |
32.1** | Certification of Principal Executive Officer pursuant to 18 U.S.C. Section 1350. | |
32.2** | Certification of Principal Financial Officer pursuant to 18 U.S.C. Section 1350. | |
101.1* | The following financial statements from the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025 formatted in XBRL: (i) Condensed Consolidated Balance Sheets, (ii) Condensed Consolidated Statements of Comprehensive Income (Loss), (iii) Condensed Consolidated Statement of Changes in Stockholders’ Equity, (iv) Condensed Consolidated Statements of Cash Flows and (v) the Notes to Condensed Consolidated Financial Statements. | |
104.1* | Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101). |
* | Filed herewith |
** | Furnished herewith |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
ORAMED PHARMACEUTICALS INC. | ||
Date: August 14, 2025 | By: | /s/ Nadav Kidron |
Nadav Kidron | ||
President and Chief Executive Officer | ||
Date: August 14, 2025 | By: | /s/ Avraham Gabay |
Avraham Gabay | ||
Chief Financial Officer | ||
(Principal Financial and Accounting Officer) |
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