Quarterly Report for Quarter Ending September 30, 2026 (Form 10-Q)

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 on Form 10-K for the fiscal year ended December 31, 2025, filed with the Securities and Exchange Commission on March 26, 2026 (our "Annual Report").

Overview of Operations

Oramed has transformed into a strategic healthcare operating company focused on building long-term value through active ownership and operational leadership. We selectively acquire meaningful strategic positions in companies where we can leverage our expertise across corporate strategy, clinical and regulatory development, commercialization, capital markets, and business growth. By partnering closely with management and providing hands-on operational guidance, we seek to accelerate innovation and unlock the full potential of our portfolio companies. Our value creation is driven by operating and growing these businesses, with a focus on long-term strategic development and real-world impact.

Recent Developments

Investment in Scilex

On October 16, 2026, we entered into a letter agreement with Scilex extending the date for payment in full of all obligations under the Tranche A Note and the Tranche B Note to November 9, 2026. In consideration of the extension, Scilex agreed to pay us a non-refundable extension fee of $1.0 million, of which $250,000 was paid upon execution of the letter agreement and received by us and $750,000 is payable on November 9, 2026. The extension fee does not reduce the amounts outstanding under the notes. If any portion of the extension fee is not paid when due, the extension terminates automatically and all obligations under the notes become immediately due and payable. Interest under the Tranche A Note continues to accrue until paid in full.

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 November 12, 2026, 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.

Results of Operations

Comparison of nine and three months ended September 30, 2026 and 2025

The following table summarizes certain statements of operations data of the Company for the nine and three months ended September 30, 2026 and 2025 (in thousands of dollars except share and per share data):

		Nine months ended								Three months ended
		September 30, 2026				September 30, 2025				September 30, 2026				September 30, 2025
Revenues		$	-			$	2,000			$	-			$	-
Cost of revenue			-				(1,987	)			-				-
Gross profit			-				13				-				-
Research and development expenses			(1,594	)			(4,393	)			-				(1,153	)
General and administrative expenses			(8,935	)			(5,036	)			(4,104	)			(1,274	)
Operating loss			(10,529	)			(9,416	)			(4,104	)			(2,427	)
Other income, net			9,347				665				487				408
Financial income, net			180,489				74,278				31,897				61,470
Income before tax expenses			179,307				65,527				28,280				59,451
Tax expenses			(44,431	)			(11,520	)			(9,870	)			(11,062	)
Net income			134,876				54,007				18,410				48,389
Net income (loss) attributable to:
Non-controlling interests			-				(34	)			-				(6	)
Company's stockholders			134,876				54,041				18,410				48,395
Basic income per share of common stock			3.28				1.30				0.44				1.16
Diluted income per share of common stock			3.17				1.26				0.43				1.13
Weighted average number of shares of common stock outstanding used in computing basic income per share of common stock			41,168,426				41,569,359				41,664,380				41,756,301
Weighted average number of shares of common stock outstanding used in computing diluted income per share of common stock			42,504,437				42,969,519				43,015,317				42,774,504

Revenues

We did not recognize any revenue in the nine months ended September 30, 2026, compared to $2,000,000 revenue recognized related to the Technology License Agreement, dated November 30, 2015, with Hefei Tianhui Biotech Co., Ltd. ("HTIT"), as amended (the "HTIT License Agreement"), for the nine months ended September 30, 2025. The decrease in recognized revenue is attributable to the full recognition of all deferred revenue under the HTIT License Agreement in prior periods.

We did not recognize any revenue in the three months ended September 30, 2026 or the three months ended September 30, 2025.

Cost of Revenues

There was no cost of revenue during the nine months ended September 30, 2026, compared to approximately $1,987,000 cost of revenue for the nine months ended September 30, 2025. Cost of revenue for the nine months ended September 30, 2025 reflected the fulfillment of our payment obligation to the Israel Innovation Authority (the "IIA") through a remittance of approximately $2,046,000, partially offset by an expense reversal of approximately $59,000. We have no further obligations to the IIA.

There was no cost of revenue during the three months ended September 30, 2026, and three months ended September 30, 2025.

Research and Development Expenses

Research and development expenses for the nine months ended September 30, 2026 decreased by 64% to approximately $1,594,000, compared to approximately $4,393,000 for the nine months ended September 30, 2025. The decrease was primarily attributable to the transfer of the POD™ technology platform activity to OraTech on March 25, 2026. Since that date, all research and development costs related to such activity have been charged to OraTech, and accordingly we recorded no research and development expenses in the second and third quarters of 2026.

There were no research and development expenses during the three months ended September 30, 2026, compared to approximately $1,153,000 for the three months ended September 30, 2025. This is due to the transfer of the POD™ technology platform activity to OraTech on March 25, 2026, following which all research and development costs related to such activity have been charged to OraTech.

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 nine months ended September 30, 2026, increased by 77% to approximately $8,935,000 compared to approximately $5,036,000 for the nine months ended September 30, 2025. The increase was mainly attributable to an increase of approximately $3,184,000 in non-cash stock-based compensation expenses. Excluding stock-based compensation expenses, general and administrative expenses increased by 27%, mainly due to increases in salary expenses and professional fees. Commencing in the second quarter of 2026, stock-based compensation expenses of our Chief Scientific Officer and Chief Operating Officer are recorded within general and administrative expenses rather than research and development expenses.

General and administrative expenses for the three months ended September 30, 2026, increased by 222% to approximately $4,104,000 compared to approximately $1,274,000 for the three months ended September 30, 2025. The increase was mainly attributable to an increase of approximately $2,635,000 in non-cash stock-based compensation expenses, as well as an increase in salary expenses. Commencing in the second quarter of 2026, stock-based compensation expenses of our Chief Scientific Officer and Chief Operating Officer are recorded within general and administrative expenses rather than research and development expenses.

Operating Loss

Operating loss was approximately $10,529,000 for the nine months ended September 30, 2026, compared to approximately $9,416,000 for the nine months ended September 30, 2025. The increase of approximately 12% was primarily attributable to an increase in general and administrative expenses, partially offset by a decrease in research and development expenses, as described above.

Operating loss was approximately $4,104,000 for the three months ended September 30, 2026, compared to approximately $2,427,000 for the three months ended September 30, 2025. The increase of approximately 69% was primarily attributable to an increase in general and administrative expenses, partially offset by a decrease in research and development expenses, as described above.

Other Income, Net

		Nine months ended								Three months ended
(U.S. dollars in thousands)		September 30, 2026				September 30, 2025				September 30, 2026				September 30, 2025
Alpha Tau Warrants and Services Agreement		$	1,256			$	665			$	409			$	408
Clinical Trial Management Agreement			270				-				78				-
Capital Gain from Sale of IP to OraTech			5,821				-				-				-
Medicox License Agreement			2,000				-				-				-
Total Other Income, Net			9,347				665				487				408

On November 13, 2022, we entered into a ten-year distribution license agreement ("Medicox License Agreement") with Medicox Co., Ltd. ("Medicox"), pursuant to which we granted Medicox an exclusive license to apply for regulatory approval and distribute ORMD-0801 in the Republic of Korea.

Following the Lifeward transaction, the expected clinical development timeline for ORMD-0801 was extended beyond the term contemplated under the Medicox License Agreement. As a result, we determined that the agreement was no longer commercially viable and that we have no remaining performance obligation thereunder. We recognized $2,000,000 income related to the Medicox License Agreement in the three months ended March 31, 2026.

Net other income was approximately $9,347,000 for the nine months ended September 30, 2026, compared to approximately $665,000 for the nine months ended September 30, 2025. The increase was primarily due to the gain on sale of IP to OraTech, income related to the Medicox License Agreement and an increase in other income related to Alpha Tau. During the nine months ended September 30, 2026, other income related to Alpha Tau amounted to approximately $1,432,000 (consisting of approximately $750,000 under the Services Agreement and approximately $682,000 in respect of the Alpha Tau Warrants), which was partially offset by IR expenses related to Alpha Tau of approximately $176,000, resulting in net other income related to Alpha Tau of approximately $1,256,000.

Net other income was approximately $487,000 for the three months ended September 30, 2026, compared to approximately $408,000 for the three months ended September 30, 2025. The increase was primarily due to income related to the Clinical Trial Management Agreement with OraTech.

Financial Income, Net

Net financial income was approximately $180,489,000 for the nine months ended September 30, 2026, compared to financial income of approximately $74,278,000 for the nine months ended September 30, 2025. The increase was primarily due to revaluation gains on the investments in Alpha Tau of approximately $174,500,000, as well as revaluation gains on the investments in Hapisga, mainly attributable to the appreciation of the NIS against the U.S. dollar, and Lifeward, and a fee received from Scilex in consideration for the extension of the maturity of the Scilex notes. The increase was partially offset by revaluation losses on the investment in Scilex of approximately $3,428,000, compared to revaluation gains of approximately $38,457,000 in the corresponding period of 2025, revaluation losses on other marketable securities and lower interest income. Financial income for the period is largely unrealized, as it primarily reflects changes in the fair value of investments we hold.

Net financial income was approximately $31,897,000 for the three months ended September 30, 2026, compared to financial income of approximately $61,470,000 for the three months ended September 30, 2025. The decrease was primarily due to revaluation losses on the investment in Scilex of approximately $5,895,000, compared to revaluation gains of approximately $34,163,000 in the corresponding period of 2025, revaluation losses on the investments in Lifeward and Hapisga, the latter mainly attributable to the depreciation of the NIS against the U.S. dollar during the quarter, and lower revaluation gains on other marketable securities. The decrease was partially offset by revaluation gains on the investments in Alpha Tau of approximately $41,083,000 and a fee received from Scilex in consideration for the extension of the maturity of the Scilex notes. Financial income for the period is largely unrealized, as it primarily reflects changes in the fair value of investments we hold.

Tax on income

During the nine months ended September 30, 2026, we recognized tax expenses on income of approximately $44,431,000 compared to tax expenses on income of approximately $11,520,000 for the nine months ended September 30, 2025. The increase in income tax expense was mainly attributable to deferred tax expense of approximately $42,226,000, primarily related to the revaluation of the investment in Alpha Tau. Current tax expense of approximately $2,205,000 was mainly attributable to the gain from the sale of IP and the Scilex transaction.

During the three months ended September 30, 2026, we recognized tax expenses on income of approximately $9,870,000 compared to tax expenses on income of approximately $11,062,000 for the three months ended September 30, 2025. Income tax expense was mainly attributable to deferred tax expense of approximately $10,594,000, primarily related to the revaluation of the investment in Alpha Tau, partially offset by a current tax benefit of approximately $724,000, which was mainly attributable to the Scilex notes.

The provision for tax on income in the interim period is determined using an estimated annual effective tax rate.

Liquidity and Capital Resources

As of September 30, 2026, we had retained earnings of approximately $11,445,000, after the distribution of a dividend of approximately $10,870,000. From our inception through September 30, 2026, 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 $28,185,000 from the exercise of warrants and options. We expect to seek additional financing through similar sources in the future, as needed. As of September 30, 2026, we had approximately $28,934,000 of available cash. In addition, we hold a variety of interests in certain investments, including in Lifeward, Scilex, Alpha Tau, Hapisga and others, as further detailed in this Quarterly Report on Form 10-Q.

From inception through September 30, 2026, we have not generated significant revenues from our operations, other than the recognition of deferred revenue related to the HTIT License Agreement and the Medicox License Agreement, as described above. Following the termination of our Phase 3 clinical trials, our research and development activities were significantly reduced while we conducted a strategic review process. Following the closing of the Lifeward transaction, the development of the oral insulin platform is conducted by OraTech, and accordingly we do not expect to incur significant research and development expenses.

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.

Material Cash Requirements and Commitments

Our material cash requirements from known contractual and other obligations as of September 30, 2026 consist primarily of the following:

Operating leases. Undiscounted lease payments for our office space and vehicles in Israel of approximately $1,795,000, of which approximately $93,000 is payable during the remainder of 2026, approximately $402,000 in 2027 and the balance through January 2032. See Note 9b.

Income taxes. Income taxes payable of approximately $5,549,000, which we expect to pay during 2027.

Ruby Sapphire II. An unfunded capital commitment of NIS 5,444,000 (approximately $1,777,000), payable upon capital calls by the fund's general partner during the fund's four year investment period, which runs through approximately mid 2029. The timing and amount of capital calls are not within our control.

Lifeward Additional Notes. Up to $9,000,000 of Additional Notes that Lifeward may require us to purchase upon satisfaction of either of the conditions described in Note 9d. As of the date of this report, neither condition has been satisfied, and we cannot predict whether or when either condition will be satisfied.

CRO agreement. Milestone-based payments under the CRO agreement described in Note 9a, which provides for aggregate payments of up to approximately $11,577,000, payable only upon achievement of specified milestones. In light of the change in the planned clinical protocol from a Phase 3 trial to a Phase 2 trial, we expect the agreement to be revised and its overall scope and cost to be significantly reduced.

We believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund these requirements for at least the next 12 months.

Off-Balance Sheet Arrangements

Bank guarantee. On September 9, 2026, in connection with the Profit Sharing Loan Agreement, we caused a bank to issue a guarantee of NIS 2,000,000 (approximately $663,000) in favor of the financing entity that provides construction financing to the borrower, securing a portion of that financing. If the borrower fails to repay the guaranteed portion, we may be required to pay up to NIS 2,000,000 under the guarantee, which is valid until March 1, 2027. As security, the bank placed a lien on a U.S. dollar deposit of approximately $868,000, which is presented as a restricted deposit.

Variable interests in unconsolidated entities. We hold variable interests in Lifeward, a VIE of which we are not the primary beneficiary. As of September 30, 2026, our maximum exposure to loss was approximately $24,897,000, the carrying amount of our interests, plus up to $9,000,000 of Additional Notes we may be required to purchase. See Note 2f.

Guarantee entered into after September 30, 2026. On November 6, 2026, in connection with a $9,000,000 mortgage loan from Fieldpoint Private Bank & Trust to MAR Bailey Avenue LLC, the entity that owns the Bailey Avenue project and in which we hold an indirect interest through MAR Oramed JV LLC, we and the two principals of MAR Development LLC entered into a guaranty under which we jointly and severally guarantee payment of 100% of the outstanding indebtedness. Our guaranty will step down to 25% of the outstanding indebtedness once the borrower meets a 1.30x debt service coverage ratio, tested on its filed tax returns. We also entered into a completion guaranty and an environmental indemnity in favor of the lender. The loan has a seven year term. The maximum potential amount of future payments under the payment guaranty is $9,000,000 plus accrued interest and enforcement costs. MAR Development LLC, its two principals and certain of its affiliates have agreed, jointly and severally, to indemnify us for amounts we pay under these guarantees, subject to limited exceptions. As of November 12, 2026, no event has occurred that would require us to make any payment under these guarantees.

Other than as described above, we do not have any off-balance sheet arrangements that have or are reasonably likely to have a current or future material effect on our financial condition, results of operations, liquidity, capital expenditures or capital resources.

Cash Flows

As of September 30, 2026, our total current assets were approximately $57,376,000 and our total current liabilities were approximately $9,446,000. On September 30, 2026, we had a working capital surplus of approximately $47,930,000 and retained earnings of approximately $11,445,000. As of December 31, 2025, our total current assets were approximately $133,271,000 and our total current liabilities were approximately $19,086,000. On December 31, 2025, we had a working capital surplus of approximately $114,185,000 and an accumulated loss of approximately $123,436,000. The decrease in working capital surplus was mainly due to the reclassification of the Hapisga loan, in the amount of approximately $27,943,000, from current assets to long-term assets following the extension of its maturity to April 2028; the use of current assets to fund long-term investments, mainly the Lifeward transaction (approximately $11,924,000, including the funding of OraTech prior to the closing) and the investments in the Warren at Bay Loan, the 83 Wythe Loan and the Profit Sharing Loan Agreement; the conversion of the Lifeward convertible note of approximately $4,636,000 into the A&R Note, which is classified as a long-term asset; revaluation losses on the Scilex notes; cash used in operating activities; and an increase in income tax payable of approximately $2,263,000.

During the nine months ended September 30, 2026, cash and cash equivalents decreased to approximately $28,934,000 from approximately $45,947,000 as of December 31, 2025. The decrease was mainly due to the reasons described below.

Operating Activities

Operating activities used cash of approximately $2,689,000 in the nine months ended September 30, 2026, compared to approximately $8,679,000 used in the nine months ended September 30, 2025. Cash used in operating activities primarily consisted of cash used in general and administrative expenses, partially offset by interest received of approximately $1,170,000 and receipts from Alpha Tau.

Investing Activities

Investing activities used cash of approximately $1,986,000 in the nine months ended September 30, 2026, compared to cash provided of approximately $7,127,000 in the nine months ended September 30, 2025. Cash used in investing activities in the nine months ended September 30, 2026 consisted primarily of purchases of marketable securities, the Lifeward transaction and investments in the Warren at Bay Loan, the 83 Wythe Loan and the Profit Sharing Loan Agreement, which were partially offset by proceeds from the sale of marketable securities, redemption of short-term deposits and repayments by Scilex. Cash provided by investing activities in the nine months ended September 30, 2025 was mainly due to redemption of short-term deposits and proceeds from investments, partially offset by investments at fair value in Alpha Tau and Hapisga.

Financing Activities

Financing activities used cash of approximately $12,273,000 in the nine months ended September 30, 2026, compared to approximately $732,000 in the nine months ended September 30, 2025. Cash used by financing activities in the nine months ended September 30, 2026 consisted of the payment of dividends and tax withholdings related to stock-based compensation settlements, partially offset by proceeds from the exercise of stock options, while cash used in the nine months ended September 30, 2025 consisted of the repurchase and retirement of common stock.

Alpha Tau Transaction

On April 24, 2025, our wholly-owned subsidiary, Oramed Ltd., entered into a share purchase agreement with Alpha Tau Medical Ltd. ("Alpha Tau"), a clinical-stage oncology company developing the Alpha DaRT™ alpha-radiation cancer therapy platform, under which, and through additional purchases since then, we have in the aggregate invested approximately $38.2 million to purchase 14,469,335 Alpha Tau ordinary shares (an average price of approximately $2.64 per share), representing approximately 17% of Alpha Tau's outstanding share capital as of November 12, 2026. Concurrently, we entered into a three-year services agreement to provide Alpha Tau investor relations and public relations services in exchange for a non-refundable fee of $3,000,000 and warrants to purchase up to 3,237,000 Alpha Tau ordinary shares at exercise prices ranging from $3.474 to $3.90 per share, subject to limited termination rights. As of September 30, 2026, the fair value of our investment in Alpha Tau, including the warrants, was approximately $252.4 million. In addition, we have the right to nominate two out of eight directors to Alpha Tau's board of directors, subject to certain conditions.

Dual Listing on the Tel Aviv Stock Exchange and Inclusion in the TA-90 and TA-125 Indices

In August 2026, Alpha Tau's ordinary shares became dual-listed for trading on the Tel Aviv Stock Exchange ("TASE"), in addition to the Nasdaq, where they trade under the symbol DRTS (Hebrew symbol דרטס), allowing investors to trade Alpha Tau ordinary shares in both U.S. dollars and New Israeli Shekels during the trading hours of each market.

On October 29, 2026, within months of its dual listing, Alpha Tau announced that its ordinary shares will be included in the TASE's TA-90 and TA-125 indices, effective November 5, 2026. The TA-125 index, considered by many Israeli investors to be the benchmark index of the TASE, comprises the 35 companies in the TA-35 index and the 90 companies in the TA-90 index, and according to Alpha Tau, it will be one of only three biomedical companies included in the TA-125. Index funds that track the TA-90 and TA-125 indices are expected to add Alpha Tau ordinary shares to their holdings.

Alpha DaRT™ Platform and Technology

Alpha Tau's Alpha DaRT platform is designed to deliver highly localized alpha radiation through intratumoral insertion of radium-224 impregnated sources into solid tumors. When the radium decays, its short-lived daughters are released and disperse while emitting high-energy alpha particles aimed at destroying tumor cells while sparing surrounding healthy tissue. This approach potentially offers a novel treatment solution for patients with otherwise difficult-to-treat cancers where conventional external beam radiation may be limited.

Clinical Development Progress

Alpha Tau is currently conducting an extensive clinical program with five concurrent FDA-approved trials in the United States, alongside additional trials in France, Italy, Israel, Japan, and planned studies in the UK. In October 2026, Alpha Tau also signed a memorandum of understanding with Samsung Medical Center in Seoul, South Korea, regarding a potential clinical trial of Alpha DaRT in pancreatic cancer patients, which would be subject to regulatory and ethics committee approvals. Alpha Tau's U.S. clinical trials are summarized below:

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ReSTART Pivotal Trial (Recurrent SCC Treatment with Alpha DaRT Radiation Therapy): A multi-center pivotal study in patients with recurrent cutaneous squamous cell carcinoma (cSCC), the second most common form of skin cancer. Alpha Tau has begun submitting modules of its Modular Pre-Market Approval (PMA) application to the FDA and has finished treating patients in its ReSTART pivotal trial, with top-line data from the trial expected in late 2026 or early 2027.

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IMPACT Study (Intratumoral Pancreatic Alpha Combination Trial): A multi-center pilot study combining Alpha DaRT with chemotherapy in patients with newly diagnosed unresectable locally advanced or metastatic pancreatic adenocarcinoma. In a pooled analysis of its first-in-human trials in Canada and Israel presented at DDW 2026, Alpha DaRT showed a 100% local disease control rate with a favorable safety profile, and a pooled analysis of three Phase I/II EUS-guided studies presented at the 2026 ASCO Annual Meeting reported median overall survival longer than historical standard-of-care benchmarks across all examined sub-groups, with no treatment-related deaths. The FDA approved an IDE supplement adding a second standard-of-care regimen alongside mFOLFIRINOX and expanding enrollment. Alpha Tau completed enrollment on August 31, 2026, with 48 patients at 10 clinical centers in the United States, Canada and Israel. Initial data are targeted for early 2027 and are intended to inform the design of a planned pivotal study.

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GBM Feasibility Study: A study in patients with recurrent glioblastoma multiforme (GBM), a highly aggressive malignant brain tumor. Alpha Tau treated the first patient in its REGAIN (Recurrent Glioblastoma Alpha-DaRT Intratumoral Therapy) trial at Ohio State University's Comprehensive Cancer Center. Interim results from the first three patients, treated between December 2025 and March 2026, demonstrated a 100% local disease control rate and a 67% complete response rate under Response Assessment in Neuro-Oncology (RANO) criteria, with a single associated grade 3 serious adverse event that resolved and no local or distant recurrences as of the data cut-off. On June 11, 2026, following its review of a pre-specified interim safety report, the FDA cleared Alpha Tau to complete enrollment of the final seven patients (up to ten in total) and authorized two additional leading U.S. academic cancer centers to join the trial. On October 19, 2026, Alpha Tau announced that the FDA approved an IDE supplement expanding REGAIN to up to 20 patients across the three authorized U.S. centers, opening the study to patients with IDH-mutant grade 4 tumors, adding progression-free survival as a secondary endpoint and regular quality-of-life assessments, and providing for an additional interim analysis. An abstract including new REGAIN trial data has been accepted for presentation at the Society for Neuro-Oncology (SNO) 2026 Annual Meeting in November 2026. Alpha DaRT previously received FDA Breakthrough Device Designation in recurrent GBM (October 2021) and was selected for the FDA's Total Product Life Cycle Advisory Program (TAP). Separately, in June 2026, Alpha Tau treated the first recurrent glioblastoma patient outside the United States-and the first in Israel-at Hadassah University Medical Center in Jerusalem under its broad-access ALL clinical protocol, marking the first international application of Alpha DaRT's brain-specific delivery system.

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Recurrent Prostate Cancer Pilot Study: A pilot study in patients with locally recurrent prostate cancer. Alpha Tau has treated prostate cancer patients in Israel and secured an FDA Investigational Device Exemption (IDE) for a U.S. trial. In June 2026, Alpha Tau entered into a strategic collaboration with Tolmar International Ltd. to commercialize Alpha DaRT for prostate cancer in the United States, as described under Regulatory and Commercial Progress below.

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Immunocompromised cSCC Study (ADMIRE - Alpha DaRT Management for Immunocompromised patients with REcurrent cSCC): A multi-center study in immunocompromised patients with cSCC. On July 15, 2026, Alpha Tau announced the successful treatment of the first patient in the ADMIRE study, performed at Banner MD Anderson Cancer Center in Gilbert, Arizona.

In addition, Alpha Tau is engaged in pre-clinical research partnerships with leading academic institutions including Mayo Clinic, McGill University, Emory University, and MD Anderson Cancer Center, exploring combinations with immunotherapy. Alpha Tau has also reported positive results from a clinical study in Israel examining the combination of Alpha DaRT with the checkpoint inhibitor pembrolizumab (Keytruda®) for patients with locally advanced or metastatic head and neck squamous cell carcinoma. As presented at the American Head and Neck Society's 12th International Conference on Head and Neck Cancer in July 2026, the combination produced a 100% objective response rate and a median overall survival of 18.2 months among nine evaluable patients, with no Alpha DaRT-associated serious adverse events, surpassing the study's pre-specified threshold for success. Alpha Tau is exploring the possibility of conducting a sixth U.S. trial in this indication.

Regulatory and Commercial Progress

In addition to the ongoing FDA engagement for its U.S. clinical programs, on February 24, 2026, Alpha Tau received Shonin marketing approval from Japan's Ministry of Health, Labour and Welfare ("MHLW") for Alpha DaRT in the treatment of unresectable locally advanced or locally recurrent head and neck cancer. Shonin is the most rigorous regulatory pathway for medical devices in Japan and is granted following review and recommendation by Japan's Pharmaceuticals and Medical Devices Agency ("PMDA"). The approval marks the first regulatory clearance of the Alpha DaRT platform outside of Israel. As a condition of approval, Alpha Tau will conduct a post-market surveillance (PMS) study enrolling 66 patients across five leading clinical centers in Japan to further evaluate Alpha DaRT's safety and clinical performance in real-world settings and generate additional clinical evidence in collaboration with Japanese physicians and treatment centers.

On the manufacturing front, Alpha Tau has received a radioactive materials license for the first phase of its Hudson, New Hampshire facility and is currently equipping the facility for Alpha DaRT manufacturing to support commercial readiness and scale-up operations.

On June 2, 2026, Alpha Tau entered into a strategic collaboration with Tolmar International Ltd. to develop and commercialize Alpha DaRT for the treatment of prostate cancer in the United States. The agreement grants Tolmar exclusive U.S. commercialization rights for prostate cancer, with an option to expand into bladder cancer subject to additional payments. Under the collaboration, Tolmar committed an initial $15 million manufacturing investment and a $20 million equity investment at $11.99 per share (a 25% premium to the 30-day VWAP), with up to $161.5 million in clinical, regulatory and commercial milestones for the first indication. Under the collaboration, Alpha Tau will manufacture and supply Alpha DaRT to Tolmar at 60% of the onward net sales price (subject to certain adjustments).

Strategic Overview Rationale

Alpha Tau has reported clinical progress across multiple difficult-to-treat cancer types, including pancreatic cancer, head and neck cancer, and skin cancer, including a 100% local disease control rate and favorable safety profile reported in a pooled analysis of its two first-in-human pancreatic adenocarcinoma trials at DDW 2026. Alpha Tau has five concurrent FDA-approved trials in the U.S., has received its first commercial approval outside Israel, in Japan, has entered into a U.S. commercialization collaboration with Tolmar for prostate cancer, and is advancing toward a PMA submission for its pivotal skin cancer trial, Alpha Tau is entering a critical phase of clinical validation and regulatory progression. Alpha Tau's innovative alpha-radiation platform, combined with its expanding clinical footprint across multiple solid tumor types and growing manufacturing capabilities, represents what we believe to be a compelling opportunity in the oncology therapeutics space.

Lifeward Transactions

Lifeward Share Purchase Agreement

On January 12, 2026, we entered into a Share Purchase Agreement with Lifeward Ltd. ("Lifeward") (Nasdaq: LFWD) and OraTech, pursuant to which Lifeward agreed to acquire all of the outstanding equity interests of OraTech from us (the "Share Purchase Agreement"). Prior to the closing, we transferred to OraTech all intellectual property and related assets relating to our POD™ (Protein Oral Delivery) technology platform, together with approximately $6,500,000 to fund the next planned clinical trial and related development activities. The transaction closed on March 25, 2026 (the "Lifeward Closing Date"), and from that date forward, OraTech will bear all research and development expenses related to the POD™ technology platform.

In consideration for the acquisition of OraTech, Lifeward issued to us: (i) 1,250,363 ordinary shares of Lifeward, no par value (the "Lifeward Ordinary Shares"), representing 45.0% of the outstanding Lifeward Ordinary Shares on the Lifeward Closing Date; (ii) 1,006,113 pre-funded warrants to purchase Lifeward Ordinary Shares at an exercise price of $0.0001 per share, exercisable and with no expiration date ("Pre-Funded Warrants"); and (iii) 1,296,296 warrants to purchase Lifeward Ordinary Shares at an exercise price of $5.40 per share ("Share Purchase Warrants"). In addition, Oramed will receive revenue-sharing payments equal to 4% of the net revenue from Lifeward's ReWalk Personal Exoskeleton products and related extended warranties for up to 10 years ("Lifeward Revenue Share"), subject to certain caps and termination events.

In addition to the Share Purchase Agreement, on the Lifeward Closing Date, we entered into a securities purchase agreement ("Lifeward Notes Purchase Agreement"), pursuant to which, on March 25, 2026, following satisfaction of closing conditions set forth in the Lifeward Notes Purchase Agreement, Lifeward issued to us $9,000,000 aggregate principal amount of senior secured convertible notes (together with senior secured convertible notes issued to other investors, the "Initial Notes"), convertible into Lifeward Ordinary Shares at a conversion price of $5.40 per share, together with warrants to purchase up to 1,666,666 Lifeward Ordinary Shares at an exercise price of $5.40 per share ("Note Warrants"). The Note Warrants are exercisable and expire five years from the date of issuance.

Under the Lifeward Notes Purchase Agreement, Lifeward also has the right to require us to fund a second tranche of $9,000,000 aggregate principal amount of senior secured convertible notes ("Additional Notes", and together with the Initial Notes, "Notes"), on substantially the same terms as the Initial Notes, together with warrants to purchase up to 1,666,666 Lifeward Ordinary Shares ("Additional Note Warrants") upon the occurrence of either of the following: (i) Lifeward's achievement of at least a 150% increase in ReWalk unit sales compared to the trailing twelve-month period immediately preceding the additional closing; or (ii) the closing price of the Lifeward Ordinary Shares equaling or exceeding $13.80 per share for 10 consecutive trading days immediately prior to the additional closing. As of September 30, 2026, neither of the foregoing conditions had been satisfied, and accordingly, the Additional Notes had not been funded.

On June 30, 2026, Lifeward entered into an additional securities purchase agreement with certain investors, pursuant to which Lifeward agreed to issue approximately $5,600,000 aggregate principal amount of additional senior secured convertible notes. The additional investment closed in July 2026, as announced by Lifeward on July 7, 2026. In connection with such investment, the Initial Notes held by us, the Share Purchase Warrants and the Pre-Funded Warrants were amended and restated (the "A&R Note", "A&R Warrants" and "A&R Pre-Funded Warrants", respectively) to, among other things, provide that the notes rank pari passu with respect to the collateral securing them.

Under the terms of the Pre-Funded Warrants, the Share Purchase Warrants, the Notes and the Note Warrants, in each case as amended and restated, we may not exercise or convert any of such instruments to the extent that we, together with our affiliates, would beneficially own more than 45.0% of the outstanding Lifeward Ordinary Shares immediately after such exercise or conversion. We may, subject to certain conditions, increase the beneficial ownership limitation upon at least 61 days' prior notice to Lifeward, subject to Lifeward's prior consent, which consent shall not be unreasonably withheld, conditioned or delayed.

Strategic Overview Rationale

Lifeward is a commercial-stage medical technology company that develops and markets a portfolio of robotics and rehabilitation solutions to help individuals with physical limitations or those recovering from injury restore mobility, function, and independence. Its product portfolio spans the continuum of rehabilitation and mobility care and includes the ReWalk Personal Exoskeleton, a wearable robotic device that enables individuals with spinal cord injury to stand, walk, and climb stairs, and the AlterG Anti-Gravity treadmill, which uses patented differential air pressure technology to provide precise body-weight support for physical therapy, athletic training, and rehabilitation. Through this established and diversified platform, Lifeward generates recurring revenue from a global customer base that includes hospitals, rehabilitation clinics, sports medicine and performance facilities, the U.S. Department of Veterans Affairs, and individual home users across the United States, Europe, and other international markets.

In February 2026, Lifeward's ReWalk Personal Exoskeleton gained Medicare Advantage coverage from Aetna, which-together with prior authorizations previously issued by UnitedHealthcare and Humana-extended coverage across three of the largest Medicare Advantage insurers, collectively representing approximately 16 million beneficiaries in the United States.

For the second quarter of 2026, Lifeward reported revenue of $6.6 million, an increase of 16% compared to the second quarter of 2025 and its strongest quarterly revenue performance since the fourth quarter of 2024. In August 2026, Lifeward launched a six-month pilot program with Ottobock Care, which operates more than 50 patient care clinics in the United States, to expand access to the ReWalk Personal Exoskeleton. In September and October 2026, two independent peer-reviewed studies were published reporting on the home use of the ReWalk Personal Exoskeleton by individuals with chronic spinal cord injury.

On August 31, 2026, Lifeward announced the appointment of Josh Hexter as Interim Chief Executive Officer, effective September 1, 2026, succeeding Mark Grant. On October 26, 2026, Lifeward's board of directors appointed Ronen Tsimerman as Lifeward's Chief Financial Officer, principal financial officer and principal accounting officer, effective November 1, 2026, succeeding Almog Adar.

We entered into this transaction as part of our ongoing portfolio optimization and continued focus on high-potential innovation, gaining near-term cash flow and diversified exposure through a significant equity interest in Lifeward's revenue-generating business; we believe that prior execution challenges at Lifeward were driven primarily by strategy and management rather than by the quality of the underlying technology, and that, with a new strategic direction and leadership team in place, Lifeward is well positioned to realize the full value of its product platform. We further believe the combination delivers long-term upside from the transferred POD™ platform and its refined oral insulin program-for which we retain responsibility for managing the near-term clinical development program-alongside the near-term contribution of Lifeward's commercial portfolio, ultimately driving meaningful growth and shareholder value.

Clinical Trial Management Agreement

In connection with the Share Purchase Agreement, we entered into a clinical trial management agreement (the "Clinical Trial Management Agreement") with OraTech, pursuant to which we agreed to manage the clinical study of OraTech's investigational oral insulin capsule product (the "Study"), including providing clinical trial management and administrative services through completion of the Study (the "Services"). In consideration for the Services, OraTech will reimburse us for all reasonable out-of-pocket expenses actually incurred by us in providing the Services and payments made on behalf of OraTech to third parties and vendors, such as clinical sites, if applicable, subject to certain limitations and maximum payments as set forth in the Clinical Trial Management Agreement. To the extent the actual cost of the Study exceeds the $6,500,000 funded to OraTech prior to the Lifeward Closing Date, we will bear such excess costs without additional consideration; based on our current estimates, we do not expect the actual cost of the Study to exceed that amount. The Clinical Trial Management Agreement will terminate upon completion of the Study unless earlier terminated in accordance with the terms set forth therein.

Critical accounting policies and estimates

Our condensed consolidated financial statements are prepared in accordance with U.S. GAAP, which requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. We evaluate our estimates on an ongoing basis. Our estimates are based on historical experience and various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ materially from those estimates. We believe the following critical accounting estimates involve the most significant judgments and estimates used in the preparation of our condensed consolidated financial statements.

During the nine months ended September 30, 2026, the Company entered into significant transactions with Lifeward, which required significant management estimates in determining the fair value of financial instruments received and significant judgment in assessing variable interest entity ("VIE") considerations in accordance with the applicable accounting guidance.

Fair value measurement of Level 3 financial instruments. Certain of our financial instruments are measured at fair value on a recurring basis using significant unobservable inputs (Level 3), including our investments in Scilex and Hapisga, our real estate loans, our Alpha Tau warrants and the A&R Warrants, A&R Note and Note Warrants issued to us by Lifeward. Determining the fair value of these instruments requires management to apply valuation techniques that incorporate significant judgments and assumptions, such as expected volatility, expected term, discount rates, discounts for lack of marketability and, where applicable, the probability and timing of future events. Changes in these assumptions could materially affect the fair value of these instruments and the related gains or losses recognized in financial income, net.

Deferred taxes. We recognize deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the carrying amounts of assets and liabilities in our financial statements and their respective tax bases, which arise primarily from unrealized gains on our investments measured at fair value. Measuring deferred taxes requires judgment, including with respect to the applicable tax rates, the expected manner and timing of realization of the underlying investments and the realizability of deferred tax assets, including the need for a valuation allowance.

Stock-based compensation - modification of awards. In September 2026, our Compensation Committee approved an exchange of certain outstanding stock options (the "Option Exchange"). We accounted for the Option Exchange as a modification of awards under ASC 718, which requires a comparison of the fair value of the modified awards with the fair value of the original awards immediately before the modification. These fair values are estimated using an option-pricing model that requires assumptions such as expected volatility, expected term and the risk-free interest rate. Based on this assessment, no incremental compensation cost was recognized in connection with the Option Exchange.

There have been no material changes to our critical accounting estimates during the nine months ended September 30, 2026, other than those described above. For additional information about our significant accounting policies, refer to the notes to the condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q and our Annual Report.